Occupational Safety and Health Standards for Shipyard Employment. | Occupational Safety and Health Administration

Publication Date:

07/01/1993
Publication Type:

Final Rule
Fed Register #:
58:35512
Standard Number:

1915
Title:

Occupational Safety and Health Standards for Shipyard Employment.

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1915

Occupational Safety and Health Standards for Shipyard Employment

AGENCY: Occupational Safety and Health Administration, Department of Labor.

ACTION: Final rule; technical amendments and redesignation.

SUMMARY: The Occupational Safety and Health Administration (OSHA) standards for shipyards are located principally in 29 CFR part 1915, Occupational Safety and Health Standards for Shipyard Employment. However, most standards for toxic substances protecting shipyard employees are printed in either 29 CFR part 1910 or in the 1970 Threshold Limit Values of the American Conference of Governmental Industrial Hygienists and cover shipyard employees by cross reference.

The Shipyard Employment Standards Advisory Committee has recommended generally that OSHA incorporate all toxic substance standards covering shipyards into 29 CFR part 1915. OSHA believes that direct incorporation of the existing toxic substance standards covering shipyard workers into 29 CFR part 1915 will be more convenient for and accessible to shipyard employers and therefore more protective of workers. There will be better knowledge of existing regulations and a higher level of compliance since almost all OSHA regulations covering the industry will be located in one, easily accessible place. Accordingly. OSHA is by this technical amendment incorporating into 29 CFR part 1915, a comprehensive subpart Z which includes the toxic substance standards and certain related standards applicable to shipyards.

EFFECTIVE DATE: July 1, 1993.

FOR FURTHER INFORMATION CONTACT: Mr. James F. Foster, OSHA Office of Public Affairs, United States Department of Labor, Room N-3641, 200 Constitution Avenue, NW. Washington, DC 20210, telephone (202) 219- 8151.

SUPPLEMENTARY INFORMATION:

BACKGROUND AND RATIONALE

Most OSHA standards governing occupational safety for shipyards are printed in 29 CFR Part 1915, Occupational Safety and Health Standards for Shipyard Employment. However, part 1915 generally does not include the text of the health standards which cover shipyard employment. Rather, it incorporates those health standards by cross reference in other documents.

Specifically, part 1915 has incorporated by cross-

reference health standards from two sources. The first, incorporated in 1915.5, 1915.12(a)(3) and (b)(3), and 1915.32(b), consist of approximately 400 exposure limits for toxic substances which are listed in the 1970 Threshold Limit Values (TLV's) of the American Conference of Governmental Industrial Hygienists (ACGIH).

The second set of health standards incorporated into part 1915 by cross reference are the single substance standards and certain other health related standards located in 29 CFR part 1910, Occupational Safety and Health Standards for General Industry. The single substance standards are located in subpart Z of part 1910. Toxic and Hazardous Substances, at 29 CFR 1910.1001 to 1910.1048. These standards appear in a separate CFR volume, which contains most of the Shipyard Safety standards.

The Shipyard Employment Standards Advisory Committee (SESAC) was organized by OSHA pursuant to the Federal Advisory Committee Act and section 7(b) of the OSH Act, to recommend one comprehensive set of standards and accompanying rationale for the shipbuilding, ship repair. and shipbreaking industries by combining part 1910 and 1915 standards, and by updating, reorganizing, clarifying and simplifying,those standards. The committee includes representatives from labor, management, government, and health and safety professionals. It holds public meetings which are announced in advance in the Federal Register. The general public may attend and address the committee. At its May 13, 1991. meeting. SESAC recommended that OSHA directly incorporate in part 1915 a subpart Z which would include the full text of the health and related standards applicable to shipyards (see transcript pp. 149 - 156). By printing the health standards applicable to shipyards in part 1915. knowledge of their requirements would increase and this would lead to better protection for employees and greater convenience and clarity for shipyard employers. OSHA concurs with the recommendations of SESAC (1). It believes that direct incorporation of the health standards, already applicable to shipyards by cross-reference, into part 1915, has important benefits.

--------

Footnote(1)

SESAC made several recommended revisions to the Access to employee exposure and medical records standard (1910.20), notably with regard to the disposition of these records after an employer ceased doing business. While these revisions may be valid and worthwhile, they nevertheless could have resulted in reduced access by employees to these records. As these revisions are substantive, they could not be included in this technical amendment. OSHA will carefully review these recommended revisions and determine whether they should be considered for future rulemaking.

First, shipyard employees will have better and more consistent health protection because all the health standards applicable to them will be readily accessible and easy to reference. There will be better knowledge of requirements necessary to protect health.

Second, the shipyard industry and its managers will have a much more convenient source for all the health requirements applicable to the industry. There will be less confusion over what regulations are applicable. This clarification also will result in a greater degree of voluntary compliance.

Third, OSHA's proposal to update the air contaminants levels for shipyards (57 FR 26002, June 12, 1992) will be delayed because of the Eleventh Circuit Court of Appeals decision to vacate similar standards for general industry in the case of AFL CIO v. OSHA, 965 F.2d 962 (1992). Consequently, convenient access to the 1970 TLV's for the shipyard industry will be necessary for a longer period and these technical amendments will be helpful for a longer period.

As stated, OSHA's standards for toxic and hazardous substances are contained in 29 CFR part 1910, subpart Z. The 29 CFR part 1910 substanc-specific standards apply to shipyard employment by virtue of two provisions. First, for some standards. 29 CFR 1910.19 directly makes the standard applicable to shipyard employment. For example. 29 CFR 1910.19(c) states that the acrylonitrile standard set forth in 1910.1045.applies to every employment and place of employment specified in 1910.13. 1910.14 and 1910.15. Those sections refer to ship repairing. shipbuilding and shipbreaking, the activities now covered by part 1915, the shipyard employment standards.

Application of the remainder of the substance-specific standards to shipyards is accomplished by virtue of 29 CFR 1910.5(c)(2). That paragraph provides that any standard will apply to employment and place of employment in any industry. even though particular standards are also prescribed for that industry, to,the extent that none of such particular standards applies. Thus, for example, because none of the particular standards applicable to the shipyard industry regulates exposure to beta Naphthylamine, the beta Naphthylamine standard, at 29 CFR 1910.1009, applies to shipyard employment.

In addition to the substance-specific standards, part 1915 also incorporates the 1970 TLVs of the American Conference of Governmental Industrial Hygienists. Part 1915 refers to the TLVs In several locations. For example, 1915.12, 1915.32, and 1915.33 refer to the threshold limit values. Section 1915.5 then identifies these "threshold limit values" as the Threshold Limit Values, 1970, of the ACGIH.

As the first step in directly Incorporating into 29 CFR part 1915 the health standards applicable to shipyards. OSHA created a new subpart Z of part 1915 when it issued the cadmium standard on September 14, 1992, at 57 FR 42102, 42388-42389. OSHA incorporated the cadmium standard into that new subpart Z of part 1915 as 1915.1027.

Elements of This Technical Amendment

1. This technical amendment creates a complete subpart Z. Toxic and Hazardous Substances, for part 1915 Shipyards. It incorporates into this subpart Z the health standards already applicable to shipyards. These include the single substance standards at 29 CFR 1910.1001-1048, which will be given the corresponding section numbers of 29 CFR 1915.1001-1915.1048 respectively. No substantive changes have been made to the requirements, but certain formal changes have been made to reflect the new location and appropriate cross references. Consequently, this Incorporation is a technical amendment.

Excluded from this incorporation are the coke oven standard, 29 CFR 1910.1029, and the cotton dust standard, 29 CFR 1910.1043, because the operations covered by these standards would not be done in shipyards.

2. OSHA is placing the air contaminants levels for shipyards in a new 29 CFR 1915.1000, Table Z-Shipyards. This will follow the numeration and style used for general industry in part 1910. This format will make the table easier to use because it will follow the same pattern used for most industry. Section 1915.1000 and Table Z-Shipyards merely reprint in, convenient form the 1970 TLVs which are already applicable to most operations in shipyards. No substantive changes are made. Consequently, this is also a technical amendment.

As noted. most areas in shipyards are presently covered by the 1970 TLV's. However, since the shipyard regulations are an amalgam of three separate bodies of regulations for shipbuilding, ship repair. and shipbreaking. a few operations have been technically covered by the 1971 OSHA permissible exposure limits (PELs). See 47 FR 16984 (April 20,1982).

Specifically. the shipbreaking and ship repairing subsectors, and the exposure to toxic solvents and removers In the shipbuilding and ship repair subsectors, are covered by the 1970 TLV's of ACGIH. See 1915.5, 1915.11, 1915.12, 1915.32, and 1915.33. The 1971 OSHA PELs, which are contained in 1910.1000, will continue to apply to shipbuilding operations not involving toxic solvents and removers. See 29 CFR 1910.5(c).

3. ACGIH made clear that the 1970 TLV "Nuisance Particulate" standard covered both organic and inorganic particulates. Appendix D of the 1970 TLV booklet listed as examples of typical nuisance particulates, various organic particulates such as cellulose, vegetable oil mists, starch, and sucrose. Some confusion was created because ACGIH printed the nuisance particulate limit as part of a table which was headed "Mineral Dusts." To resolve this confusion and to make it clear that the "nuisance particulate" exposure limit covers both inorganic and organic nuisance particulates, OSHA is including a footnote to this effect after the "Inert or Nuisance Particulate" entry. OSHA is also including a duplicate listing titled "Particulates not otherwise regulated (PNOR)" with the same exposure limit. The purpose of this duplicate listing is to make the limit easier to find by using current terminology.

4. The hazard communication standard is currently included in part 1915 as 29 CFR 1915.99. As this is primarily a health-related standard, it is more convenient to redesignate it as 1915.1200 to reflect the same numeration as general idustry and to include it with the other health standards in subpart Z of part 1915.

5. Two other health-related standards already applicable to shipyards by cross reference are being incorporated in full text into subpart Z as recommended by SESAC These standards are 1910.20, Access to employee exposure and medical records, which will be incorporated as 1915.1120, and 1910.1450 Occupational exposure to hazardous chemicals in laboratories, which will be incorporated as 1915.1450.

Necessary consequential changes are made to 1915.5. 1915.12, and 1915.32 to reference subpart Z (which now includes the 1970 TLV's) rather then referencing the ACGIH publication.

6. The general industry asbestos standard at 29 CFR 1910.1001 now specifically applies to shipyards. It is being directly incorporated into part 1915 as 1915.1001. Shipyard representatives have recommended to OSHA in the asbestos remand rulemaking that an asbestos standard tailored to shipyards be developed. OSHA is presently considering this issue, but has not made a final decision. If OSHA concludes that changes in the asbestos standard for shipyards are appropriate, OSHA will amend 1915.1001 to reflect any such changes when the final rule on the asbestos remand is published in the Federal Register.

Conclusion

As this is a technical amendment, it is adopted for the convenience of the shipyard employers and employees. it effects no significant substantive changes, and it has also been supported by SESAC. OSHA concludes that it is unnecessary to provide for notice and comment, as permitted by section 4 of the Administrative Procedure Act, 5 U.S.C. 553(b) and 1911.5.

As this is not a substantive rule, it may take effect upon publication in the Federal Register. OSHA finds good cause for this rule to take effect June 30, 1993, so that these technical amendments will be incorporated in the 1993 edition of the CFR and thereby increase the convenience to the public as soon as possible. See 5 U.S.C. 553(d).

For the same reasons, it is certified that no substantive changes are being made which would require analysis under the Regulatory Flexibility Act or under Executive Order 12291.

List of Subjects in 29 CFR Part 1915

Shipyards, Shipbuilding, Ship repairing, Shipbreaking, Toxic chemicals, Air contaminants, Coal tar pitch volatile, 4-Nitrobiphenyl, alpha-Naphthylamine, Methyl chloromethyl ether, 3,3'-Dichlorobenzidine (and its salts), bis-Chloromethyl ether, beta-Naphthylamine, Benzidine, 4-Aminodiphenyl, Ethyleneimine, betaPropiolactone, 2- Actylaminofluorene, 4-Dimethylaminoazobenzene, Nitrosodimethylamine, Vinyl chloride, Inorganic arsenic, Lead, Benzene, Acrylonitrile, Ethylene oxide, Formaldehyde, Asbestos, Hazard Communication, Laboratories, Medical records, Monitoring records.

Authority and Signature

This document was prepared under the direction of David C. Zeigler, Acting Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210.

Accordingly, pursuant to sections 6 and 8 of the Occupational Safety and Health Act (29 U.S.C. 655, 657); section 41, Longshore and Harbor Workers Compensation Act (33 U.S.C. 941); section 4 of the Administrative Procedure Act (5 U.S.C. 553); and Secretary of Labor's Order No. 1-90 (55 FR 9033); OSHA is issuing these final technical amendments.

Signed at Washington. DC. this 24th day of June, 1993.

David C. Zeigler,
Acting Assistant Secretary of Labor.

29 CFR part 1915 is amended as follows:

PART 1915--(AMENDED)

1. The authority citation of part 1915 is revised to read as follows:

Authority: § 41, longshore and Harbor Workers Compensation Act (33 U.S.C. 941); § 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655. 657); § 4 of the Administrative procedure Act (5 U.S.C. 553); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35735) or 1-90 (55 FR 9033), as applicable; 29 CFR part 1911.

2. Section 1915.5 is amended by adding a sentence to the paragraph incorporating the Threshold Limit Values (the seventh paragraph that lists organizations that are not agencies of the U.S. government). As amended, this paragraph reads as follows:

1915.5 Reference specification, standards, and codes.

* * * * *

Threshold Limit Values, 1970, American Conference of Governmental Industrial Hygienists, 1014 Broadway, Cincinnati, Ohio 45202, subpart 1915.12(a)(3); subpart C, 1915.32(b). These threshold limit values are contained in 1915.1000, Table Z.

* * * * *

3. Paragraphs (a)(3) and (b)(3) of 1915.12 are revised to read as follows:

1915.12 Precautions before entering.

(a) Flammable atmospheres and residues.

* * * * *

(3) If the atmosphere in the space to be entered is found to contain a concentration of flammable vapor or gas below the level immediately dangerous to life as defined in 1915.152(b)(1), but above the permissible exposure limits specified In 29 CFR part 1915, table employees shall be protected in accordance with the requirements of 1915.152(a), and (c), (d). or whichever is applicable.

(b)Toxic atmospheres and residues. * * * * * (3) If the atmosphere In the space to be entered is found to contain a concentration of toxic contaminants below the level immediately dangerous to life as defined in 1915.152 but above the permissible exposure limits specified In 29 CFR part 1915, table Z, employees shall be protected in accordance with the requirements of 1915.152(a), and (c),(d), or wichever is applicable.

* * * * *

1915.99 [Redesignated as 1915.1200]

4. Section 1915.99 Hazard communication, is redesignated as 1915.1200.

5. Subparts M-Y are reserved and subpart Z is revised to read as follows:

* * * * *

Subparts M-Y [Reserved]

Subpart Z-Toxic and Hazardous Substances

§ 1915.1000 Air contaminants.
1915.1001 Asbestos.
1915.1002 Coal tar pitch volatiles; interpretation of term.
1915.1003 4-Nitrobiphenyl.
1915.1004 alpha-Naphthylamine.
1915.1005 [Reserved]
1915.1006 Methyl chloromethyl ether.
1915.1007 3,3'Dichlorobenzidiene (and its salts).
1915.1008 bis-Chloromethyl ether.
1915.1009 beta-Naphthylamine.
1915.1010 Benzidine.
1915.1011 4-Aminodiphenyl.
1915.1012 Ethyleneimine.
1915.1013 beta-Propiolactone.
1915.1014 2-Acetylaminofluorene.
1915.1015 4-Dimethylaminoazohenzene.
1915.1016 N-Nitrosodimeyhylamine.
1915.1017 Vinyl chloride.
1915.1018 lnorganic arsenic.
1915.1025 Lead.
1915.1027 Cadmium.
1915.1028 Benzene.
1915.1030 Bloodborne pathogens
1915.1044 1,2 dibromo-3-chloropropane
1915.1045 Acrylonitrile.
1915.1047 Ethylene oxide.
1915.1048 Formaldehyde.
1915.1050 Methylenedianiline
1915.1120 Access to employee exposure and medical records.
1915.1200 Hazard communication.
1915.1450 Occupational exposure to hazardous chemicals in
laboratories.

Authority: § 41 longshore and Harbor Workers Compensation Act (33 U.S.C 941); secs. 4, 6, 8, Occupational Safety and Heath Act of 1970 (29 U.S.C. 653, 655, 657); §4 of the Administrative Procedure Act (5 U.S.C. 553); Secretary of Labor's Order No. 12-71 (36 F 8754, 8-76 (41 FR 25059), 9-83 (48 FR 35736) or 1-90 (55 FR 9033), as applicable; 29 CFR part 1911.

* * * * *

Subpart Z - Toxic and Hazardous Substances

1915.1000 Air contaminants.

Wherever this section applies, an employees's exposure to any substance listed in Table Z-Shipyards of this section shall be limited in accordance with the requirements of the following paragraphs of this section.

(a) - (1) "Substances with limits preceded by 'C'" - "Ceiling Values."

An employee's exposure to any substance in Table Z-Shipyards, the exposure limit of which is preceded by a "C," shall at no time exceed the exposure limit given for that substance. If instantaneous monitoring is not feasible, then the ceiling shall be assessed as a 15-minute time weighted average exposure which shall not be exceeded at any time over a working day.

(2) "Other Substances" - "8-hour Time Weighted Averages." An employee's exposure to any substance in Table Z-Shipyards , the exposure limit of which is not preceded by a "C," shall not exceed the 8-hour Time Weighted Average given for that substance in any 8-hour work shift of a 40-hour work week.

(b)-(c) [Reserved] (d) "Computation formulae." The computation formula which shall apply to employee exposure to more than one substance for which 8-hour time weighted averages are listed in subpart Z of 29 CFR part 1915 in order to determine whether an employee is exposed over the regulatory limit is as follows:

(1) - (i) The cumulative exposure for an 8-hour work shift shall be computed as follows:

E = (C(a)T(a) + C(b) +...C(n)T(n)) + 8

Where:

E is the equivalent exposure for the working shift. C is the concentration during any period of time T where the concentration remains constant.

T is the duration in hours of the exposure at the concentration C.

The value of E shall not exceed the 8-hour time weighted average specified in subpart Z of 29 CFR Part 1915 for the material involved.

(ii) To illustrate the formula prescribed in paragraph (d)(1)(i) of this section, assume that Substance A has an 8-hour time weighted average limit of 100 ppm noted in Table Z-Shipyards. Assume that an employee is subject to the following exposure:

Two hours exposure at 150 p/m
Two hours exposure at 75 p/m
Four hours exposure at 50 p/m
Substituting this information in the formula, we have

(2 X 150 +2 X 75 + 4 X 50) + 8 = 81.25 p/m

Since 81.25 ppm is less than 100 p.p.m., the 8-hour time weighted average limit, the exposure is acceptable.

(2)(i) in case of a mixture of air contaminants an employer shall compute the equivalent exposure as follows:

E(m) = (C(1) + L(1) +L(2)) +...(C(n) + L(n))

Where:
E(m)	is the equivalent exposure for the mixture

C	is the concentration of a particular contaminant

L	is the exposure limit for that substance specified in Subpart Z of 29 CFR Part 1915
	The value of E(m) shall not exceed unity (1)
	(ii) To illustrate the formula prescribed in paragraph (d)(2)(i) of this section, consider the following exposures:

Substance

Actual concentration of
8 hour exposure (ppm)

18 hr. TWA PEL (ppm)

500

1000

200

Substituting in the formula, we have:
Em = 500 + 1,000 + 45 + 200 + 40 + 200
Em = 0.500 + 0.225 + 0.200
Em = 0.925

Since Em is less than unity (1), the exposure combination is within acceptable limits.

__________

NOTE: Because of the length of the table, explanatory Footnotes applicable to all substances are given below as well as at the end of the table. Footnotes specific only to a limited number of substances are also shown within the table.

Footnote(1) [Reserved]

Footnote(2) See Mineral Dusts Table.

Footnote(3) Use Asbestos Limit 1915.1001.

Footnote(4) See 1915.1001

Footnote(*) The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit. They are to be determined from breathing-zone air samples.

Footnote(a) Parts of vapor or gas per million parts of contaminated air by volume at 25 degrees C and 760 torr.

Footnote(b) Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when listed with a ppm entry, it is approximate.

Footnote(c) [Reserved]

Footnote(d) The CAS number is for information only. Enforcement is based on the substance name. For an entry covering more than one metal compound, measured as the metal, the CAS number for the metal is given - not CAS numbers for the individual compounds.

Footnote(e) [Reserved]

Footnote(f) [Reserved]

Footnote(g) For sectors excluded from 1915.1028 the limit is 10 ppm TWA.

Footnote(h) Where OSHA has published a proposal for a substance but has not issued a final rule, the proposal is referenced and the existing limit is published.

Footnote(i) [Reserved]

Footnote(j) Millions of particles per cubic foot of air, based on impinger samples counted by light-field techniques.

Footnote(k) The percentage of crystalline silica in the formula is the amount determined from airborne samples, except in those instances in which other methods have been shown to be applicable.

Footnote(l) [Reserved]

Footnote(m) Covers all organic and inorganic particulates not otherwise regulated. Same as Particulates Not Otherwise Regulated.

The 1970 TLV uses letter designations instead of a numerical value as follows:

Footnote(A(1)) [Reserved]

Footnote(A(2)) Polytetrafluoroethylene decomposition products. Because these products decompose in part by hydrolysis in alkaline solution, they can be quantitatively determined in air as fluoride to provide an index of exposure. No TLV is recommended pending determination of the toxicity of the products, but air concentrations should be minimal.

Footnote(A(3)) Gasoline and/or Petroleum distillates. The composition of these materials varies greatly and thus a single TLV for all types of these materials is no longer applicable. The content of benzene, other aromatics and additives should be determined to arrive at the appropriate TLV.

Footnote(E) Simple asphyxiants. The limiting factor is the available oxygen which shall be at least 18 percent and be within the requirements addressing explosion in subpart B of part 1915.

TABLE Z-SHIPYARDS
Substance	CAS No. (d)	ppm (a)	mg/m(3)(h)	Skin Designation
Abate; see Temephos
Acetaldehyde	75-07-0	200	360
Acetic acid	64-19-7	10	25
Acetic anhydride	108-24-7	5	20
Acetone	67-64-1	1000	2400
Acetonitrile	75-05-8	40	70
2-Acetylaminofluorine;
see 1915.1014	53-96-3
Acetylene	74-86-2	E
Acetylene dichloride;
see
1,2-Dichloroethylene
Acetylene tetrabromide	79-27-6	1	14
Acrolein	107-02-8	0.1	0.25
Acrylamide	79-06-1		0.3	X
Acrylonitrile;
see 1915.1045	107-13-1
Aldrin	309-00-2		0.25	X
Allyl alcohol	107-18-6	2	5	X
Allyl chloride	107-05-1	1	3
Allyl glycidyl ether
(AGE)	106-92-3	(C)10	(C)45
Allyl propyl disulfide	2179-59-1	2	12
alpha-Alumina	1344-28-1
Total dust			15
Respirable fraction			5
Aluminum (as Al) Metal	7429-90-5
Total dust			15
Respirable fraction			5
Alundum; see
alpha-Alumina
4-Aminodiphenyl;
see 1915.1011	92-67-1
2-Aminoethanol;
see Ethanolamine
2-Aminopyridine	504-29-0	0.5	2
Ammonia	7664-41-7	50	35
Ammonium sulfamate	7773-06-0
Total dust			15
Respirable fraction			5
n-Amyl acetate	628-63-7	100	525
sec-Amyl acetate	626-38-0	125	650
Aniline and homologs	62-53-3	5	19	X
Anisidine
(o-,p-isomers)	29191-52-4		0.5	X
Antimony and compounds
(as Sb)	7440-36-0		0.5
ANTU (alpha
Naphthylthiourea)	86-88-4		0.3
Argon	7440-37-1	E
Arsenic, inorganic
compounds (as As);
see 1915.1018	7440-38-2
Arsenic, organic
compounds (as As)	7440-38-2		0.5
Arsine	7784-42-1	0.05	0.2
Asbestos;
see 1915.1001
Azinphos-methyl	86-50-0		0.2	X
Barium, soluble
compounds (as Ba)	7440-39-3		0.5
Barium sulfate	7727-43-7
Total dust			15
Respirable fraction			5
Benomyl	17804-35-2
Total dust			15
Respirable fraction			5
Benzene(g); See
1915.1028	71-43-2
Benzidine;
See 1915.1010	92-87-5
p-Benzoquinone;
see Quinone
Benzo(a)pyrene; see
Coal tar pitch
volatiles
Benzoyl peroxide	94-36-0		5
Benzyl chloride	100-44-7	1	5
Beryllium and
beryllium compounds
(as Be)	7440-41-7		0.002
Biphenyl; see Diphenyl
Bismuth telluride,
Undoped	1304-82-1
Total dust			15
Respirable fraction			5
Bisphenol A; see
Diglycidyl ether
Boron oxide	1303-86-2
Total dust			15
Boron tribromide	10294-33-4	1	10
Boron trifluoride	7637-07-2	(C)1	(C)3
Bromine	7726-95-6	0.1	0.7
Bromine pentafluoride	7789-30-2	0.1	0.7
Bromoform	75-25-2	0.5	5	X
Butadiene
(1,3-Butadiene)(h)	106-99-0	1000	2200
Butanethiol;
see Butyl mercaptan
2-Butanone
(Methyl ethyl ketone)	78-93-3	200	590
2-Butoxyethanol	111-76-2	50	240	X
n-Butyl-acetate	123-86-4	150	710
sec-Butyl acetate	105-46-4	200	950
tert-Butyl-acetate	540-88-5	200	950
n-Butyl alcohol	71-36-3	100	300
sec-Butyl alcohol	78-92-2	150	450
tert-Butyl alcohol	75-65-0	100	300
Butylamine	109-73-9	(C)5	(C)15	X
tert-Butyl chromate
(as CrO(3))	1189-85-1		(C)0.1	X
n-Butyl glycidyl ether
(BGE)	2426-08-6	50	270
Butyl mercaptan	109-79-5	0.5	1.5
p-tert-Butyltoluene	98-51-1	10	60
Cadmium dust fume
(as Cd);
see 1915.1027	7440-43-9
Calcium Carbonate	1317-65-3
Total dust			15
Respirable fraction			5
Calcium hydroxide	1305-62-0
Total dust			15
Respirable fraction			5
Calcium oxide	1305-78-8		5
Calcium silicate	1344-95-2
Total dust			15
Respirable fraction			5
Calcium sulfate	7778-18-9
Total dust			15
Respirable fraction			5
Camphor, synthetic	76-22-2		2
Carbaryl (Sevin)	63-25-2		5
Carbon black	1333-86-4		3.5
Carbon dioxide	124-38-9	5000	9000
Carbon disulfide	75-15-0	20	60	X
Carbon monoxide	630-08-0	50	55
Carbon tetrachloride	56-23-5	10	65	X
Cellulose	9004-34-6
Total dust			15
Respirable fraction			5
Chlordane	57-74-9		0.5	X
Chlorinated camphene	8001-35-2		0.5	X
Chlorinated diphenyl
oxide	55720-99-5		0.5
Chlorine	7782-50-5	1	3
Chlorine trifluoride	7790-91-2	(C)0.1	(C)0.4
Chloroacetaldehyde	107-20-0	(C)1	(C)3
a-Chloroacetophenone
(Phenacyl chloride)	532-27-4	0.05	0.3
Chlorobenzene	108-90-7	75	350
o-Chlorobenzylidene
malononitrile	2698-41-1	0.05	0.4
Chlorobromomethane	74-97-5	200	1050
2-Chloro-1,3-butadiene;
See beta-Chloroprene
Chlorodiphenyl
(42% Chlorine)(PCB)	53469-21-9		1	X
Chlorodiphenyl
(54% Chlorine)(PCB)	11097-69-1		0.5	X
1-Chloro-2,
3-epoxypropane;
See Epichlorohydrin
2-Chloroethanol; See
Ethylene chlorohydrin
Chloroethylene;
See Vinyl chloride
Chloroform
(Trichloromethane)	67-66-3	50	240
bis(Chloromethyl)
ether; see 1915.1008	542-88-1
Chloromethyl methyl
ether; see 1915.1006	107-30-2
1-Chloro-1-nitropropane	600-25-9	20	100
Chloropicrin	76-06-2	0.1	0.7
beta-Chloroprene	126-99-8	25	90	X
2-Chloro-6
(trichloromethyl)
pyridine	1929-82-4
Total dust			15
Respirable fraction			5
Chromic acid and
chromates (as CrO(3))	Varies with		0.1
	compound
Chromium (II) compounds
(as Cr)	7440-47-3		0.5
Chromium (III)
compounds (as Cr)	7440-47-3		0.5
Chromium metal and
insol. salts (as Cr)	7440-47-3		1
Chrysene; see Coal tar
pitch volatiles
Clopidol	2971-90-6
Total dust			15
Respirable fraction			5
Coal tar pitch
volatiles (benzene
soluble fraction),
anthracene, BaP,
phenanthrene,
acridine, chrysene,
pyrene	65966-93-2		0.2
Cobalt metal, dust,
and fume (as Co)	7440-48-4		0.1
Copper	7440-50-8
Fume (as Cu)			0.1
Dusts and mists
(as Cu)			1
Corundum; see Emery
Cotton dust (raw)			1
Crag herbicide (Sesone)	136-78-7
Total dust			15
Respirable fraction			5
Cresol, all isomers	1319-77-3	5	22	X
Crotonaldehyde	123-73-9	2	6
	4170-30-3
Cumene	98-82-8	50	245	X
Cyanides (as CN)	Varies with		5
	Compound
Cyanogen	460-19-5	10
Cyclohexane	110-82-7	300	1050
Cyclohexanol	108-93-0	50	200
Cyclohexanone	108-94-1	50	200
Cyclohexene	110-83-8	300	1015
Cyclonite	121-82-4		1.5	X
Cyclopentadiene	542-92-7	75	200
2,4-D (Dichlorophen-
oxyacetic acid)	94-75-7		10
Decaborane	17702-41-9	0.05	0.3	X
Demeton (Systox)	8065-48-3		0.1	X
Diacetone alcohol
(4-Hydroxy-4-methyl-
2-pentanone)	123-42-2	50	240
1,2-Diaminoethane;
see Ethylenediamine
Diazomethane	334-88-3	0.2	0.4
Diborane	19287-45-7	0.1	0.1
1,2-Dibromo-3-
chloropropane (CBCP);
see 1915.1044	96-12-8
1,2-Dibromoethane; see
Ethylene dibromide
Dibutyl phosphate	107-66-4	1	5
Dibutyl phthalate	84-74-2		5
Dichloroacetylene	7572-29-4	(C)0.1	(C)0.4
o-Dichlorobenzene	95-50-1	(C)50	(C)300
p-Dichlorobenzene	106-46-7	75	450
3,3'-Dichlorobenzidine;
see 1915.1007	91-94-1
Dichlorodifluoromethane	75-71-8	1000	4950
1,3-Dichloro-5,
5-dimethyl hydantoin	118-52-5		0.2
Dichlorodiphenyltri-
chloroethane (DDT)	50-29-3		1	X
1,1-Dichloroethane	75-34-3	100	400
1,2-Dichloroethane; see
Ethylene dichloride
1,2-Dichloroethylene	540-59-0	200	790
Dichloroethyl ether	111-44-4	(C)15	(C)90	X
Dichloromethane; see
Methylene chloride
Dichloromonofluoro-
methane	75-43-4	1000	4200
1,1-Dichloro-1-
nitroethane	594-72-9	(C)10	(C)60
1,2-Dichloropropane;
see
Propylene dichloride
Dichlorotetrafluoro-
ethane	76-14-2	1000	7000
Dichlorvos (DDVP)	62-73-7		1	X
Dicyclopentadienyl iron	102-54-5
Total dust			15
Respirable fraction			5
Dieldrin	60-57-1		0.25	X
Diethylamine	109-89-7	25	75
2-Diethylaminoethanol	100-37-8	10	50
Diethylene triamine	111-40-0	(C)10	(C)42	X
Diethyl ether;
see Ethyl ether
Difluorodibromomethane	75-61-6	100	860
Diglycidyl ether (DGE)	2238-07-5	(C)0.5	(C)2.8
Dihydroxybenzene;
see Hydroquinone
Diisobutyl ketone	108-83-8	50	290
Diisopropylamine	108-18-9	5	20	X
4-Dimethylaminoazo-
benzene;
see 1915.1015	60-11-7
Dimethoxymethane;
see Methylal
Dimethyl acetamide	127-19-5	10	35	X
Dimethylamine	124-40-3	10	18
Dimethylaminobenzene;
see Xylidine
Dimethylaniline
(N,N-Dimethylaniline)	121-69-7	5	25	X
Dimethylbenzene;
see Xylene
Dimethyl-1,2-dibromo-2,
2-dichloroethyl
phosphate	300-76-5		3
Dimethylformamide	68-12-2	10	30	X
2,6-Dimethyl-4-
heptanone; see
Diisobutyl ketone
1,1-Dimethylhydrazine	57-14-7	0.5	1	X
Dimethylphthalate	131-11-3		5
Dimethyl sulfate	77-78-3	1	5	X
Dinitrobenzene
(all isomers)			1	X
(ortho)	528-29-0
(meta)	99-65-0
(para)	100-25-4
Dinitro-o-cresol	534-52-1		0.2	X
Dinitrotoluene	25321-14-6		1.5	X
Dioxane
(Diethylene dioxide)	123-91-1	100	360	X
Diphenyl (Biphenyl)	92-52-4	0.2	1
Diphenylamine	122-39-4		10
Diphenylmethane
diisocyanate; see
Methylene bisphenyl
isocyanate
Dipropylene glycol
methyl ether	34590-94-8	100	600	X
Di-sec octyl phthalate
(Di-(2-ethylhexyl)
phthalate)	117-81-7		5
Emery	12415-34-8
Total dust			15
Respirable fraction			5
Endosulfan	115-29-7		0.1	X
Endrin	72-20-8		0.1	X
Epichlorohydrin	106-89-8	5	19	X
EPN	2104-64-5		0.5	X
1,2-Epoxypropane; see
Propylene oxide
2,3-Epoxy-1-propanol;
see Glycidol
Ethane	74-84-0	E
Ethanethiol; see
Ethyl mercaptan
Ethanolamine	141-43-5	3	6
2-Ethoxyethanol
(Cellosolve)	110-80-5	200	740	X
2-Ethoxyethyl acetate
(Cellosolve acetate)	111-15-9	100	540	X
Ethyl acetate	141-78-6	400	1400
Ethyl acrylate	140-88-5	25	100	X
Ethyl alcohol (Ethanol)	64-17-5	1000	1900
Ethylamine	75-04-7	10	18
Ethyl amyl ketone
(5-Methyl-3-
heptanone)	541-85-5	25	130
Ethyl benzene	100-41-4	100	435
Ethyl bromide	74-96-4	200	890
Ethyl butyl ketone
(3-Heptanone)	106-35-4	50	230
Ethyl chloride	75-00-3	1000	2600
Ethyl ether	60-29-7	400	1200
Ethyl formate	109-94-4	100	300
Ethyl mercaptan	75-08-1	0.5	1
Ethyl silicate	78-10-4	100	850
Ethylene	74-85-1	E
Ethylene chlorohydrin	107-07-3	5	16	X
Ethylenediamine	107-15-3	10	25
Ethylene dibromide	106-93-4	(C)25	(C)190	X
Ethylene dichloride
(1,2-Dichloroethane)	107-06-2	50	200
Ethylene glycol
dinitrate	628-96-6	(C)0.2	(C)1	X
Ethylene glycol methyl
acetate; see Methyl
cellosolve acetate
Ethyleneimine;
see 1915.1012	151-56-4
Ethylene oxide;
see 1915.1047	75-21-8
Ethylidene chloride;
see 1,1-Dichlorethane
N-Ethylmorpholine	100-74-3	20	94	X
Ferbam	14484-64-1
Total dust			15
Ferrovanadium dust	12604-58-9		1
Fibrous Glass
Total dust			15
Respirable fraction			5
Fluorides (as F)	Varies with		2.5
	compound
Fluorine	7782-41-4	0.1	0.2
Fluorotrichloromethane
(Trichloro-
fluoromethane)	75-69-4	1000	5600
Formaldehyde;
see 1915.1048	50-00-0
Formic acid	64-18-6	5	9
Furfural	98-01-1	5	20	X
Furfuryl alcohol	98-00-0	50	200
Gasoline	8006-61-9		A(3)
Glycerin (mist)	56-81-5
Total dust			15
Respirable fraction			5
Glycidol	556-52-5	50	150
Glycol monoethyl ether;
see 2-Ethoxyethanol
Graphite, natural
respirable dust	7782-42-5	(2)	(2)	(2)
Graphite, synthetic
Total dust			15
Respirable Fraction			5
Guthion;
see Azinphos methyl
Gypsum	13397-24-5
Total dust			15
Respirable fraction			5
Hafnium	7440-58-6		0.5
Helium	7440-59-7	E
Heptachlor	76-44-8		0.5	X
Heptane (n-Heptane)	142-82-5	500	2000
Hexachloroethane	67-72-1	1	10	X
Hexachloronaphthalene	1335-87-1		0.2	X
n-Hexane	110-54-3	500	1800
2-Hexanone (Methyl
n-butyl ketone)	591-78-6	100	410
Hexone (Methyl
isobutyl ketone)	108-10-1	100	410
sec-Hexyl acetate	108-84-9	50	300
Hydrazine	302-01-2	1	1.3	X
Hydrogen	1333-74-0	E
Hydrogen bromide	10035-10-6	3	10
Hydrogen chloride	7647-01-0	(C)5	(C)7
Hydrogen cyanide	74-90-8	10	11	X
Hydrogen fluoride
(as F)	7664-39-3	3	2
Hydrogen peroxide	7722-84-1	1	1.4
Hydrogen selenide
(as Se)	7783-07-5	0.05
Hydrogen sulfide	7783-06-4	10	15
Hydroquinone	123-31-9		2
Indene	95-13-6	10	45
Indium and compounds
(as in)	7440-74-6		0.1
Iodine	7553-56-2	(C)0.1	(C)1
Iron oxide fume	1309-37-1		10
Iron salts (soluble)
(as Fe)	Varies with		1
	compound
Isomyl acetate	123-92-2	100	525
Isomyl alcohol
(primary and
secondary)	123-51-3	100	360
Isobutyl acetate	110-19-0	150	700
Isobutyl alcohol	78-83-1	100	300
Isophorone	78-59-1	25	140
Isopropyl acetate	108-21-4	250	950
Isopropyl alcohol	67-63-0	400	980
Isopropylamine	75-31-0	5	12
Isopropyl ether	108-20-3	500	2100
Isopropyl glycidyl
ether (IGE)	4016-14-2	50	240
Kaolin	1332-58-7
Total dust			15
Respirable fraction			5
Ketene	463-51-4	0.5	0.9
Lead inorganic (as Pb);
see 1915.1025	7439-92-1
Limestone	1317-65-3
Total dust			15
Respirable fraction			5
Lindane	58-89-9		0.5	X
Lithium hydride	7580-67-8		0.025
L.P.G. (Liquified
petroleum gas)	68476-85-7	1000	1800
Magnesite	546-93-0
Total dust			15
Respirable fraction			5
Magnesium oxide fume	1309-48-4
Total Particulate		15
Malathion	121-75-5
Total dust			15	X
Maleic anhydride	108-31-6	0.25
Manganese compounds
(as Mn)	7439-96-5		(C)5
Manganese fume (as Mn)	7439-96-5		(C)5
Marble	1317-65-3
Total dust			15
Respirable fraction			5
Mercury (aryl and
inorganic)(as Hg)	7439-97-6		0.1	X
Mercury (organo) alkyl
compounds (as Hg)	7439-97-6		0.01	X
Mercury (vapor) (as Hg)	7439-97-6		0.1	X
Mesityl oxide	141-79-7	25	100
Methane	74-82-8	E
Methanethiol;
see Methyl mercaptan
Methoxychlor	72-43-5
Total dust			15
2-Methoxyethanol;
(Methyl cellosolve)	109-86-4	25	80	X
2- Methoxyethyl acetate
(Methyl cellosolve
acetate)	110-49-6	25	120	X
Methyl acetate	79-20-9	200	610
Methyl acetylene
(Propyne)	74-99-7	1000	1650
Methyl acetylene
propadiene mixture
(MAPP)		1000	1800
Methyl acrylate	96-33-3	10	35	X
Methylal
(Dimethoxy-methane)	109-87-5	1000	3100
Methyl alcohol	67-56-1	200	260
Methylamine	74-89-5	10	12
Methyl amyl alcohol;
see Methyl Isobutyl
carbinol
Methyl n-amyl ketone	110-43-0	100	465
Methyl bromide	74-83-9	(C)20	(C)80	X
Methyl butyl ketone;
see 2-Hexanone
Methyl cellosolve;
see 2-Methoxyethanol
Methyl cellosolve
acetate;
see 2-Methoxyethyl
acetate
Methyl chloride	74-87-3	100	210
Methyl chloroform
(1,1,1-Trichloro-
ethane)	71-55-6	350	1900
Methylcyclohexane	108-87-2	500	2000
Methylcyclohexanol	25639-42-3	100	470
o-Methylcyclohexanone	583-60-8	100	460	X
Methylene chloride	75-09-2	500	1740
Methyl ethyl ketone
(MEK); see 2-Butanone
Methyl formate	107-31-3	100	250
Methyl hydrazine
(Monomethyl
hydrazine)	60-34-4	(C)0.2	(C)0.35	X
Methyl iodide	74-88-4	5	28	X
Methyl isoamyl ketone	110-12-3	100	475
Methyl isobutyl
carbinol	108-11-2	25	100	X
Methyl isobutyl ketone;
see Hexone
Methyl isocyanate	624-83-9	0.02	0.05	X
Methyl mercaptan	74-93-1	0.5	1
Methyl methacrylate	80-62-6	100	410	100
Methyl propyl ketone;
see 2-Pentanone
Methyl silicate	681-84-5	5	30
alpha-Methyl styrene	98-83-9	(C)100	(C)480
Methylene bisphenyl
isocyanate (MDI)	101-68-8	(C)0.02	(C)0.2
Mica; see Silicates
Mineral wool
Total dust			15
Respirable dust			5
Molybdenum (as Mo)	7439-98-7
Soluble compounds			5
Insoluble Compounds
Total dust			15
Monomethyl aniline	100-61-8	2	9	X
Monomethyl hydrazine;
see Methyl hydrazine
Morpholine	110-91-8	20	70	X
Naphtha (Coal tar)	8030-30-6	100	400
Naphthalene	91-20-3	10	50
alpha-Naphthylamine;
see 1915.1004	134-32-7
beta-Naphthylamine;
see 1915.1009	91-59-8
Neon	7440-01-9	E
Nickel carbonyl (as Ni)	13463-39-3	0.001	0.007
Nickel, metal and
insoluble compounds
(as Ni)	7440-02-0		1
Nickel, soluble
compounds (as Ni)	7440-02-0		1
Nicotine	54-11-5		0.5	X
Nitric acid	7697-37-2	2	5
Nitric oxide	10102-43-9	25	30
p-Nitroaniline	100-01-6	1	6	X
Nitrobenzene	98-95-3	1	5	X
p-Nitrochlorobenzene	100-00-5		1	X
4-Nitrodiphenyl;
see 1915.1003	92-93-3
Nitroethane	79-24-3	100	310
Nitrogen	7727-37-9	E
Nitrogen dioxide	10102-44-0	(C)5	(C)9
Nitrogen trifluoride	7783-54-2	10	29
Nitroglycerin	55-63-0	(C)0.2	(C)2	X
Nitromethane	75-52-5	100	250
1-Nitropropane	108-03-2	25	90
2-Nitropropane	79-46-9	25	90
N-Nitrosodimethylamine;
see 1915.1016	62-79-9
Nitrotoluene
(all isomers)		5	30	X
o-isomer	88-72-2
m-isomer	99-08-1
p-isomer	99-99-0
Nitrotrichloromethane;
see Chloropicrin
Nitrous oxide	10024-97-2	E
Octachloronaphthalene	2234-13-1		0.1	X
Octane	111-65-9	400	1900
Oil mist, mineral	8012-95-1		5
Osmium tetroxide
(as Os)	20816-12-0		0.002
Oxalic acid	144-62-7		1
Oxygen difluoride	7783-41-7	0.05	0.1
Ozone	10028-15-6	0.1	0.2
Paraquat, respirable
dust	4685-14-7		0.5	X
	1910-42-5
	2074-50-2
Parathion	56-38-2		0.1
Particulates not
otherwise regulated
Total dust organic
and inorganic			15
PCB; see Chlorodiphenyl
(42% and 54%
chlorine)
Pentaborane	19624-22-7	0.005	0.01
Pentachloronaphthalene	1321-64-8		0.5	X
Pentachlorophenol	87-86-5		0.5	X
Pentaerythritol	115-77-5
Total dust			15
Respirable fraction			5
Pentane	109-66-0	500	1500
2-Pentanone (Methyl
propyl ketone)	107-87-9	200	700
Perchloroethylene
(Tetrachloroethylene)	127-18-4	100	670
Perchloromethyl
mercaptan	594-42-3	0.1	0.8
Perchloryl fluoride	7616-94-6	3	13.5
Perlite	93763-70-3
Total dust			15
Respirable fraction			5
Petroleum distillates
(Naphtha)(Rubber
Solvent)			A(3)
Phenol	108-95-2	5	19	X
p-Phenylene diamine	106-50-3		0.1	X
Phenyl ether, vapor	101-84-8	1	7
Phenyl ether-biphenyl
mixture, vapor		1	7
Phenylethylene;
see Styrene
Phenyl glycidyl ether
(PGE)	122-60-1	10	60
Phenylhydrazine	100-63-0	5	22	X
Phosdrin (Mevinphos)	7786-34-7		0.1	X
Phosgene (Carbonyl
chloride)	75-44-5	0.1	0.4
Phosphine	7803-51-2	0.3	0.4
Phosphoric acid	7664-38-2		1
Phosphorus (yellow)	7723-14-0		0.1
Phosphorus
pentachloride	10026-13-8		1
Phosphorus pentasulfide	1314-80-3		1
Phosphorus trichloride	7719-12-2	0.5	3
Phthalic anhydride	85-44-9	2	12
Picloram	1918-02-1
Total dust			15
Respirable fraction			5
Picric acid	88-89-1		0.1
Piperazine
dihydrochloride	142-64-3			X
Pindone (2-Pivalyl-1,
3-indandione)	83-26-1		0.1
Plaster of paris	26499-65-0
Total dust			15
Respirable fraction			5
Platinum (as Pt)	7440-06-4
Metal
Soluble Salts			0.002
Polytetrafluoroethylene
decomposition
products			A(2)
Portland cement	65997-15-1
Total dust		15		10
Respirable fraction		5
Propargyl alcohol	107-19-7	1		X
beta-Propriolactone;
see 1915.1013	57-57-8
Propionic acid	79-09-4
n-Propyl acetate	109-60-4	200	840
n-Propyl alcohol	71-23-8	200	500
n-Propyl nitrate	627-13-4	25	110
Propylene dichloride	78-87-5	75	350
Propylene imine	75-55-8	2	5	X
Propylene oxide	75-56-9	100	240
Propyne; see Methyl
acetylene
Pyrethrum	8003-34-7		5
Pyridine	110-86-1	5	15
Quinone	106-51-4	0.1	0.4
RDX: see Cyclonite
Rhodium (as Rh), metal
fume and insoluble
compounds	7440-16-6		0.1
Rhodium (as Rh),
soluble compounds	7440-16-6		0.001
Ronnel	299-84-3		10
Rotenone	83-79-4		5
Rouge
Total dust			15
Respirable fraction			5
Selenium compounds
(as Se)	7782-49-2		0.2
Selenium hexafluoride
(as Se)	7783-79-1	0.05	0.4
Silica, amorphous,
precipitated and gel	112926-00-8	(2)	(2)	(2)
Silica, amorphous,
diatomaceous earth,
containing less than
1% crystalline silica	61790-53-2	(2)	(2)	(2)
Silica, crystalline
cristobalite,
respirable dust	14464-46-1	(2)	(2)	(2)
Silica, crystalline
quartz, respirable
dust	14808-60-7	(2)	(2)	(2)
Silica, crystalline
tripoli (as quartz),
respirable dust	1317-95-9	(2)	(2)	(2)
Silica, crystalline
tridymite,
respirable dust	15468-32-3	(2)	(2)	(2)
Silica, fused,
respirable dust	60676-86-0	(2)	(2)	(2)
Silicates (less than 1%
crystalline silica)
Mica (respirable
dust)	12001-26-2	(2)	(2)	(2)
Soapstone, total dust		(2)	(2)	(2)
Soapstone, respirable
dust		(2)	(2)	(2)
Talc (containing
asbestos)		(3)	(3)	(3)
Talc (containing no
asbestos),
respirable dust	14807-96-6	(2)	(2)	(2)
Tremolite		(3)	(3)	(3)
Silicon	7440-21-3
Total dust			15
Respirable fraction			5
Silicon carbide	409-21-2
Total dust			15
Respirable fraction			5
Silver, metal and
soluble compounds
(as Ag)	7440-22-4		0.01
Soapstone;
see Silicates
Sodium fluoroacetate	62-74-8		0.05	X
Sodium hydroxide	1310-73-2		2
Starch	9005-25-8
Total dust			15
Respirable fraction			5
Stibine	7803-52-3	0.1	0.5
Stoddard solvent	8052-41-3	200	1150
Strychnine	57-24-9		0.15
Styrene	100-42-5	100	420	50
Sucrose	57-50-1
Total dust			15
Respirable fraction			5
Sulfur dioxide	7446-09-5	5	13
Sulfur hexafluoride	2551-62-4	1000	6000
Sulfuric acid	7664-93-9		1
Sulfur monochloride	10025-67-9	1	6
Sulfur pentafluoride	5714-22-7	0.025	0.25
Sulfuryl fluoride	2699-79-8	5	20
Systox; see Demeton
2,4,5-T (2,4,5-tri-
chlorophenoxyacetic
acid)	93-76-5		10
Talc; see Silicates
Tantalum, metal and
oxide dust	7440-25-7		5
TEDP (Sulfotep)	3689-24-5		0.2	X
Teflon decomposition
products			A2
Tellurium and
compounds (as Te)	13494-80-9		0.1
Tellurium hexafluoride
(as Te)	7783-80-4	0.02	0.2
Temephos	3383-96-8
Total dust			15
Respirable fraction			5
TEPP (Tetraethyl
pyrophosphaate)	107-49-3		0.05	X
Terphenylis	26140-60-3	(C)1	(C)9
1,1,1,2-Tetrachloro-2,
2-difluoroethane	76-11-9	500	4170
1,1,2,2-Tetrachloro-1,
2-difluoroethane	76-12-0	500	4170
1,1,2,2-Tetrachloro-
ethane	79-34-5	5	35	X
Tetrachoroethylene;
see Perchloroethylene
Tetrachloromethane; see
Carbon tetrachloride
Tetrachloronaphthalene	1335-88-2		2	X
Tetraethyl lead (as Pb)	78-00-2		0.1	X
Tetrahydrofuran	109-99-9	200	590
Tetramethyl lead,
(as Pb)	75-74-1		0.15	X
Tetramethyl
succinonitrile	3333-52-6	0.5	3	X
Tetranitromethane	509-14-8	1	8
Tetryl (2,4,6-Trinitro-
phenylmethyl-
nitramine)	479-45-8		1.5	X
Thallium, soluble
compounds (as Tl)	7440-28-0		0.1	X
4,4'-Thiobis(6-tert,
Butyl-m-cresol)	96-69-5
Total dust			15
Respirable fraction			5
Thiram	137-26-8		5
Tin, inorganic
compounds (except
oxides) (as Sn)	7440-31-5		2
Tin, organic compounds
(as Sn)	7440-31-5		0.1
Tin oxide (as Sn)	21651-19-4
Total dust			15
Respirable fraction			5
Titanium dioxide	13463-67-7
Total dust			15
Toluene	108-88-3	200	750	100
Toluene-2,
4-diisocyanate (TDI)	584-84-9	(C)0.02	(C)0.14
o-Toluidine	95-53-4	5	22	X
Toxaphene; see
Chlorinated camphene
Tremolite;
see Silicates
Tributyl phosphate	126-73-8		5
1,1,1-Trichloroethane;
see Methyl chloroform
1,1,2-Trichloroethane	79-00-5	10	45	X
Trichloroethylene	79-01-6	100	535
Trichloromethane;
see Chloroform
Trichloronaphthalene	1321-65-9		5	X
1,2,3-Trichloropropane	96-18-4	50	300
1,1,2-Trichloro-1,2,
2-trifluoroethane	76-13-1	1000	7600
Triethylamine	121-44-8	25	100
Trifluorobromomethane	75-63-8	1000	6100
Trimethyl benzene	25551-13-7	25	120
2,4,6-Trinitrophenyl;
see Picric acid
2,4,6-Trinitrophenyl-
methyl nitramine;
see Tetryl
2,4,6-Trinitrotoluene
(TNT)	118-96-7		1.5	X
Triorthocresyl
phosphate	78-30-8		0.1
Triphenyl phosphate	115-86-6		3
Tungsten (as W)	7440-33-7
Insoluble compounds			5
Soluble compounds			1
Turpentine	8006-64-2	100	560
Uranium (as U)	7440-61-1
Soluble compounds			0.2
Insoluble compounds			0.2
Vanadium	1314-62-1
Respirable dust
(as V(2)O(5))			(C)0.5
Fume (as V(2)O(5))			(C)0.1
Vegetable oil mist
Total dust			15
Respirable fraction			5
Vinyl benzene;
see Styrene
Vinyl chloride;
see 1915.1017	75-01-4
Vinyl cyanide;
see Acrylonitrile
Vinyl toluene	25013-15-4	100	480
Warfarin	81-81-2		0.1
Xylenes
(o-, m-, p-isomers)	1330-20-7	100	435
Xylidine	1300-73-8	5	25	X
Yttrium	7440-65-5		1
Zinc chloride fume	7646-85-7		1
Zinc oxide fume	1314-13-2		5
Zinc oxide	1314-13-2
Total dust			15
Respirable fraction			5
Zinc stearate	557-05-1
Total dust			15
Respirable fraction			5
Zirconium compounds
(as Zr)	7440-67-7		5

MINERAL DUSTS
Substance	mppcf(j)

SILICA:
Crystalline
Quartz. Threshold limit calculated from the
formula	250(k)

	percent SiO(2)+5
Cristobalite
Amorphous, including natural diatomaceous
earth	20
SILICATES (less than 1 percent crystalline
silica)
Mica	20
Portland cement	50
Soapstone	20
Talc (non-asbestiform)	20
Talc (fibrous), use asbestos limit	--
Graphite (natural)	15

Inert or Nuisance Particulates:(m)	50 (or 15 mg/m(3) whichever is the the smaller) of total dust less than 1 percent SiO(2)
Conversion factors
mppcf X 35.3 = million particles
per cubic meter = particles per c.c

Footnote(1) [Reserved] Footnote(2) See Mineral Dusts Table. Footnote(3) Use Asbestos Limit 1915.1001. Footnote(4) See 1915.1001 Footnote(*) The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit. They are to be determined from breathing-zone air samples.

Footnote(a) Parts of vapor or gas per million parts of contaminated air by volume at 25 degrees C and 760 torr.

Footnote(b) Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when listed with a ppm entry, it is approximate.

Footnote(c) [Reserved] Footnote(d) The CAS number is for information only. Enforcement is based on the substance name. For an entry covering more than one metal compound, measured as the metal, the CAS number for the metal is given - not CAS numbers for the individual compounds.

Footnote(e) [Reserved] Footnote(f) [Reserved] Footnote(g) For sectors excluded from 1915.1028 the limit is 10 ppm TWA. Footnote(h) Where OSHA has published a proposal for a substance but has not issued a final rule, the proposal is referenced and the existing limit is published.

Footnote(i) [Reserved] Footnote(j) Millions of particles per cubic foot of air, based on impinger samples counted by light-field techniques.

Footnote(k) The percentage of crystalline silica in the formula is the amount determined from airborne samples, except in those instances in which other methods have been shown to be applicable.

Footnote(l) [Reserved] Footnote(m) Covers all organic and inorganic particulates not otherwise regulated. Same as Particulates Not Otherwise Regulated.

The 1970 TLV uses letter designations instead of a numerical value as follows:

Footnote(A(1)) [Reserved] Footnote(A(2)) Polytetrafluoroethylene decomposition products. Because these products decompose in part by hydrolysis in alkaline solution, they can be quantitatively determined in air as fluoride to provide an index of exposure. No TLV is recommended pending determination of the toxicity of the products, but air concentrations shaould be minimal.

Footnote(E) Simple asphyxiants. The limiting factor is the available oxygen which shall be at least 18 percent and be within the requirements addressing explosion in subpart B of part 1915.

[58 FR 35514, July 1, 1993]

1915.1001 Asbestos

(a) "Scope and application." (1) This section applies to all occupational exposures to asbestos in all industries covered by the Occupational Safety and Health Act, except as provided in paragraph (a)(2) of this section.

(2) This section does not apply to construction work as defined in 29 CFR 1910.12(b). [Exposure to asbestos in construction work is covered by 29 CFR 1926.58.] (b) "Definitions." "Action level" means an airborne concentration of asbestos, of 0.1 fiber per cubic centimeter (f/cc) of air calculated as an eight (8)-hour time-weighted average.

"Asbestos" includes chrysotile, amosite, crocidolite, tremolite asbestos, anthophyllite asbestos, actinolite asbestos, and any of these minerals that have been chemically treated and/or altered.

"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.

"Authorized person" means any person authorized by the employer and required by work duties to be present in regulated areas.

"Director" means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee.

"Employee exposure" means that exposure to airborne asbestos that would occur if the employee were not using respiratory protective equipment.

"Fiber" means a particulate form of asbestos, 5 micrometers or longer, with a length-to-diameter ratio of at least 3 to 1.

"High-efficiency particulate air (HEPA) filter" means a filter capable of trapping and retaining at least 99.97 percent of 0.3 micrometer diameter mono-disperse particles.

"Regulated area" means an area established by the employer to demarcate areas where airborne concentrations of asbestos exceed, or can reasonably be expected to exceed, the permissible exposure limit.

(c) "Permissible exposure limits (PELS)" - (1) "Time-weighted average limit (TWA)." The employer shall ensure that no employee is exposed to an airborne concentration of asbestos in excess of 0.2 fiber per cubic centimeter of air as an eight (8)-hour time-weighted average (TWA) as determined by the method prescribed in Appendix A of this section, or by an equivalent method.

(2) "Excursion limit." The employer shall ensure that no employee is exposed to an airborne concentration of asbestos in excess of 1.0 fiber per cubic centimeter of air (1 f/cc) as averaged over a sampling period of thirty (30) minutes.

(d) "Exposure monitoring" - (1) "General." (i) Determinations of employee exposure shall be made from breathing zone air samples that are representative of the 8-hour TWA and 30-minute short-term exposures of each employee.

(ii) Representative 8-hour TWA employee exposures shall be determined on the basis of one or more samples representing full-shift exposures for each shift for each employee in each job classification in each work area. Representative 30-minute short-term employee exposures shall be determined on the basis of one or more samples representing 30 minute exposures associated with operations that are most likely to produce exposures above the excursion limit for each shift for each job classification in each work area.

(2) "Initial monitoring." (i) Each employer who has a workplace or work operation covered by this standard, except as provided for in paragraphs (d)(2)(ii) and (d)(2)(iii) of this section, shall perform initial monitoring of employees who are, or may reasonably be expected to be exposed to airborne concentrations at or above the action level and/or excursion limit.

(ii) Where the employer has monitored after December 20, 1985, for the TWA and after March 14, 1988, for the excursion limit, and the monitoring satisfies all other requirements of this section, the employer may rely on such earlier monitoring results to satisfy the requirements of paragraph (d)(2)(i) of this section.

(iii) Where the employer has relied upon objective data that demonstrates that asbestos is not capable of being released in airborne concentrations at or above the action level and/or excursion limit under the expected conditions of processing, use, or handling, then no initial monitoring is required.

(3) "Monitoring frequency (periodic monitoring) and patterns." After the initial determinations required by paragraph (d)(2)(i) of this section, samples shall be of such frequency and pattern as to represent with reasonable accuracy the levels of exposure of the employees. In no case shall sampling be at intervals greater than six months for employees whose exposures may reasonably be foreseen to exceed the action level and/or excursion limit.

(4) "Changes in monitoring frequency." If either the initial or the periodic monitoring required by paragraphs (d)(2) and (d)(3) of this section statistically indicates that employee exposures are below the action level and/or excursion limit, the employer may discontinue the monitoring for those employees whose exposures are represented by such monitoring.

(5) "Additional monitoring." Notwithstanding the provisions of paragraphs (d)(2)(ii) and (d)(4) of this section, the employer shall institute the exposure monitoring required under paragraphs (d)(2)(i) and (d)(3) of this section whenever there has been a change in the production, process, control equipment, personnel or work practices that may result in new or additional exposures above the action level and/or excursion limit or when the employer has any reason to suspect that a change may result in new or additional exposures above the action level and/or excursion limit.

(6) "Method of monitoring." (i) All samples taken to satisfy the monitoring requirements of paragraph (d) shall be personal samples collected following the procedures specified in Appendix A.

(ii) All samples taken to satisfy the monitoring requirements of paragraph (d) shall be evaluated using the OSHA Reference Method (ORM) specified in Appendix A of this section, or an equivalent counting method.

(iii) If an equivalent method to the ORM is used, the employer shall ensure that the method meets the following criteria:

(A) Replicate exposure data used to establish equivalency are collected in side-by-side field and laboratory comparisons; and

(B) The comparison indicates that 90 percent of the samples collected in the range 0.5 to 2.0 times the permissible limit have an accuracy range of plus or minus 25 percent of the ORM results with a 95 percent confidence level as demonstrated by a statistically valid protocol; and

(iv) To satisfy the monitoring requirements of paragraph (d) of this section, employers must use the results of monitoring analysis performed by laboratories which have instituted quality assurance programs that include the elements as prescribed in Appendix A.

(7) "Employee notification of monitoring results." (i) The employer shall, within 15 working days after the receipt of the results of any monitoring performed under the standard, notify the affected employees of these results in writing either either individually or by posting of results in an appropriate location that is accessible to affected employees.

(ii) The written notification required by paragraph (d)(7)(i) of this section shall contain the corrective action being taken by the employer to reduce employee exposure to or below the TWA and/or excursion limit, wherever monitoring results indicated that the TWA and/or excursion limit had been exceeded.

(e) "Regulated Areas" - (1) "Establishment." The employer shall establish regulated areas wherever airborne concentrations of asbestos are in excess of the TWA and/or excursion limit prescribed in paragraph (c) of this section.

(2) "Demarcation." Regulated areas shall be demarcated from the rest of the workplace in any manner that minimizes the number of persons who will be exposed to asbestos.

(3) "Access." Access to regulated areas shall be limited to authorized persons or to persons authorized by the Act or regulations issued pursuant thereto.

(4) "Provision of respirators." Each person entering a regulated area shall be supplied with and required to use a respirator, selected in accordance with paragraph (g)(2) of this section.

(5) "Prohibited activities." The employer shall ensure that employees do not eat, drink, smoke, chew tobacco or gum, or apply cosmetics in the regulated areas.

(f) "Methods of compliance" - (1) "Engineering controls and work practices." (i) The employer shall institute engineering controls and work practices to reduce and maintain employee exposure to or below the TWA and/or excursion limit, prescribed in paragraph (c) of this section, except to the extent that such controls are not feasible.

(ii) Wherever the feasible engineering controls and work practices that can be instituted are not sufficient to reduce employee exposure to or below the TWA and/or excursion limit prescribed in paragraph (c) of this section, the employer shall use them to reduce employee exposure to the lowest levels achievable by these controls and shall supplement them by the use of respiratory protection that complies with the requirements of paragraph (g) of this section.

(iii) For the following operations, wherever feasible engineering controls and work practices that can be instituted are not sufficient to reduce the employee exposure to or below the TWA and/or excursion limit, prescribed in paragraph (c) of this section, the employer shall use them to reduce employee exposure to or below 0.5 fiber per cubic centimeter of air (as an eight-hour time-weighted average) or 2.5 fibers/cc for 30 minutes (short-term exposure) and shall supplement them by the use of any combination of respiratory protection that complies with the requirements of paragraph (g) of this section, work practices and feasible engineering controls that will reduce employee exposure to or below the TWA and to or below the excursion limit prescribed in paragraph (c) of this section: Coupling cutoff in primary asbestos cement pipe manufacturing; sanding in primary and secondary asbestos cement sheet manufacturing; grinding in primary and secondary friction product manufacturing; carding and spinning in dry textile processes; and grinding and sanding in primary plastics manufacturing.

(iv) Local exhaust ventilation. Local exhaust ventilation and dust collection systems shall be designed, constructed, installed, and maintained in accordance with good practices such as those found in the American National Standard Fundamentals Governing the Design and Operation of Local Exhaust Systems, ANSI Z9.2-1979.

(v) "Particular tools." All hand-operated and power-operated tools with would produce or release fibers of asbestos so as to expose employees to levels in excess of the TWA and/or excursion limit prescribed in paragraph (c) of this section, such as, but not limited to saws, scorers, abrasive wheels, and drills, shall be provided with local exhaust ventilation systems which comply with paragraph (f)(1)(iv) of this section.

(vi) "Wet methods." Insofar as practicable, asbestos shall be handled, mixed, applied, removed, cut, scored, or otherwise worked in a wet state sufficient to prevent the emission of airborne fibers so as to expose employees to levels in excess of the TWA and/or excursion limit, prescribed in paragraph (c) of this section, unless the usefulness of the product would be diminished thereby.

(vii) [Reserved] (viii) "Particular products and operations." No asbestos cement, mortar, coating, grout, plaster, or similar material containing asbestos shall be removed from bags, cartons, or other containers in which they are shipped, without being either wetted, or enclosed, or ventilated so as to prevent effectively the release of airborne fibers of asbestos so as to expose employees to levels in excess of the TWA and/or excursion limit prescribed in paragraph (c) of this section.

(ix) "Compressed air." Compressed air shall not be used to remove asbestos or materials containing asbestos, unless the compressed air is used in conjunction with a ventilation system designed to capture the dust cloud created by the compressed air.

(2) "Compliance program." (i) Where the TWA and/or excursion limit is exceeded, the employer shall establish and implement a written program to reduce employee exposure to or below the TWA and to or below the excursion limit by means of engineering and work practice controls as required by paragraph (f)(1) of this section, and by the use of respiratory protection where required or permitted under this section.

(ii) Such programs shall be reviewed and updated as necessary to reflect significant changes in the status of the employer's compliance program.

(iii) Written programs shall be submitted upon request for examination and copying to the Assistant Secretary, the Director, affected employees and designated employee representatives.

(iv) The employer shall not use employee rotation as a means of compliance with the TWA and/or excursion limit.

(g) "Respiratory protection" - (1) "General." The employer shall provide respirators, and ensure that they are used, where required by this section. Respirators shall be used in the following circumstances:

(i) During the interval necessary to install or implement feasible engineering and work practice controls;

(ii) In work operations, such as maintenance and repair activities, or other activities for which engineering and work practice controls are not feasible;

(iii) In work situations where feasible engineering and work practice controls are not yet sufficient to reduce exposure to or below the TWA and/or excursion limit; and

(iv) In emergencies. (2) "Respirator selection." (i) Where respirators are required under this section, the employer shall select and provide, at no cost to the employee, the appropriate respirator as specified in Table 1. The employer shall select respirators from among those jointly approved as being acceptable for protection by the Mine Safety and Health Administration (MSHA) and by the National Institute for Occupational Safety and Health (NIOSH) under the provisions of 30 CFR Part 11.

(ii) The employer shall provide a powered, air-purifying respirator in lieu of any negative pressure respirator specified in Table 1 whenever:

(A) An employee chooses to use this type of respirator; and

(B) This respirator will provide adequate protection to the employee.

TABLE 1 - RESPIRATORY PROTECTION FOR ASBESTOS FIBERS
Airborne concentration of asbestos	Required respirator

Not in excess of 2 f/cc (10 X PEL)	1. Half-mask air-purifying respirator, other than a disposable respirator, equipped with high-efficiency filters
Not in excess of 10 f/cc (50 X PEL)	1. Full facepiece air-purifying respirator equipped with high-efficiency filters
Not in excess of 20 f/cc (100 X PEL)	1. Any powered air-purifying respirator equipped with high-efficiency filters 2. Any supplied-air respirator operated in continuous flow mode
Not in excess of 200 f/cc (1000 X PEL) demand mode	1. Full facepiece supplied-air respirator operated in pressure
Greater than 200 f/cc (less than 1,000 X PEL) or unknown concentration	1. Full facepiece supplied air respirator operated in pressure demand mode equipped with an auxiliary positive pressure self-contained breathing apparatus

Note: a. Respirators assigned for higher environmental concentrations may be used at lower concentrations.

b. A high-efficiency filter means a filter that is at least 99.97 percent efficient against mono-dispersed particles of 0.3 micrometers or larger.

(3) "Respirator program." (i) Where respiratory protection is required, the employer shall institute a respirator program in accordance with 29 CFR 1910.134(b), (d), (e), and (f).

(ii) The employer shall permit each employee who uses a filter respirator to change the filter elements whenever an increase in breathing resistance is detected and shall maintain an adequate supply of filter elements for this purpose.

(iii) Employees who wear respirators shall, be permitted to leave the regulated area to wash their faces and respirator facepieces whenever necessary to prevent skin irritation associated with respirator use.

(iv) No employee shall be assigned to tasks requiring the use of respirators if, based upon his or her most recent examination, an examining physician determines that the employee will be unable to function normally wearing a respirator, or that the safety or health of the employee or other employees will be impaired by the use of a respirator. Such employee shall be assigned to another job or given the opportunity to transfer to a different position whose duties he or she is able to perform with the same employer, in the same geographical area and with the same seniority, status, and rate of pay the employee had just prior to such transfer, if such a different position is available.

(4) "Respirator fit testing." (i) The employer shall ensure that the respirator issued to the employee exhibits the least possible facepiece leakage and that the respirator is fitted properly.

(ii) For each employee wearing negative pressure respirators, employers shall perform either quantitative or qualitative face fit tests at the time of initial fitting and at least every six months thereafter. The qualitative fit tests may be used only for testing the fit of half-mask respirators where they are permitted to be worn, and shall be conducted in accordance with Appendix C. The tests shall be used to select facepieces that provide the required protection as prescribed in Table I.

(h) "Protective work clothing and equipment" - (1) "Provision and use."

If an employee is exposed to asbestos above the TWA and/or excursion limit, or where the possibility of eye irritation exists, the employer shall provide at no cost to the employee and ensure that the employee uses appropriate work clothing and equipment such as, but not limited to:

(i) Coveralls or similar full-body work clothing;

(ii) Gloves, head coverings, and foot coverings; and

(iii) Face shields, vented goggles, or other appropriate protective equipment which complies with 1910.133 of this title.

(2) "Removal and storage." (i) The employer shall ensure that employees remove work clothing contaminated with asbestos only in change rooms provided in accordance with paragraph (i)(1) of this section.

(ii) The employer shall ensure that no employee takes contaminated work clothing out of the change room, except those employees authorized to do so for the purpose of laundering, maintenance, or disposal.

(iii) Contaminated work clothing shall be placed and stored in closed containers which prevent dispersion of the asbestos outside the container.

(iv) Containers of contaminated protective devices or work clothing which are to be taken out of change rooms or the workplace for cleaning, maintenance or disposal, shall bear labels in accordance with paragraph (j)(2) of this section.

(3) "Cleaning and replacement." (i) The employer shall clean, launder, repair, or replace protective clothing and equipment required by this paragraph to maintain their effectiveness. The employer shall provide clean protective clothing and equipment at least weekly to each affected employee.

(ii) The employer shall prohibit the removal of asbestos from protective clothing and equipment by blowing or shaking.

(iii) Laundering of contaminated clothing shall be done so as to prevent the release of airborne fibers of asbestos in excess of the permissible exposure limits prescribed in paragraph (c) of this section.

(iv) Any employer who gives contaminated clothing to another person for laundering shall inform such person of the requirement in paragraph (h)(3)(iii) of this section to effectively prevent the release of asbestos in excess of the permissible exposure limits.

(v) The employer shall inform any person who launders or cleans protective clothing or equipment contaminated with asbestos of the potentially harmful effects of exposure to asbestos.

(vi) Contaminated clothing shall be transported in sealed impermeable bags, or other closed, impermeable containers, and labeled in accordance with paragraph (j) of this section.

(i) "Hygiene facilities and practices" - (1) "Change rooms." (i) The employer shall provide clean change rooms for employees who work in areas where their airborne exposure to asbestos is above the TWA and/or excursion limit.

(ii) The employer shall ensure that change rooms are in accordance with 1910.141(e) of this title, and are equipped with two separate lockers or storage facilities, so separated as to prevent contamination of the employee's street clothes from his protective work clothing and equipment.

(2) "Showers." (i) The employer shall ensure that employees who work in areas where their airborne exposure is above the TWA and/or excursion limit shower at the end of the work shift.

(ii) The employer shall provide shower facilities which comply with 1910.141(d)(3) of this title.

(iii) The employer shall ensure that employees who are required to shower pursuant to paragraph (i)(2)(i) of this section do not leave the workplace wearing any clothing or equipment worn during the work shift.

(3) "Lunchrooms." (i) The employer shall provide lunchroom facilities for employees who work in areas where their airborne exposure is above the TWA and/or excursion limit.

(ii) The employer shall ensure that lunchroom facilities have a positive pressure, filtered air supply, and are readily accessible to employees.

(iii) The employer shall ensure that employees who work in areas where their airborne exposure is above the TWA and/or excursion limit wash their hands and faces prior to eating, drinking or smoking.

(iv) The employer shall ensure that employees do not enter lunchroom facilities with protective work clothing or equipment unless surface asbestos fibers have been removed from the clothing or equipment by vacuuming or other method that removes dust without causing the asbestos to become airborne.

(4) "Smoking in work areas." The employer shall ensure that employees do not smoke in work areas where they are occupationally exposed to asbestos because of activities in that work area.

(j) "Communication of hazards to employees" - (1) "Warning signs." (i) Posting. Warning signs shall be provided and displayed at each regulated area. In addition, warning signs shall be posted at all approaches to regulated areas so that an employee may read the signs and take necessary protective steps before entering the area.

(ii) Sign specifications. The warning signs required by paragraph (j)(1)(i) of this section shall bear the following information:

DANGER ASBESTOS CANCER AND LUNG DISEASE HAZARD AUTHORIZED PERSONNEL ONLY RESPIRATORS AND PROTECTIVE CLOTHING ARE REQUIRED IN THIS AREA

(iii) [Reserved]

(iv) The employer shall ensure that employees working in and contiguous to regulated areas comprehend the warning signs required to be posted by paragraph (j)(1)(i) of this section. Means to ensure employee comprehension may include the use of foreign languages, pictographs and graphics.

(2) "Warning labels." (i) Labeling. Warning labels shall be affixed to all raw materials, mixtures, scrap, waste, debris, and other products containing asbestos fibers, or to their containers.

(ii) Label specifications. The labels shall comply with the requirements of 29 CFR 1915.1200(f) of OSHA's Hazard Communication standard, and shall include the following information:

DANGER CONTAINS ASBESTOS FIBERS AVOID CREATING DUST CANCER AND LUNG DISEASE HAZARD

(3) "Material safety data sheets." Employers who are manufacturers or importers of asbestos or asbestos products shall comply with the requirements regarding development of material safety data sheets as specified in 29 CFR 1915.1200(g) of OSHA's Hazard Communication standard, except as provided by paragraph (j)(4) of this section.

(4) The provisions for labels required by paragraph (j)(2) or for material safety data sheets required by paragraph (j)(3) do not apply where:

(i) Asbestos fibers have been modified by a bonding agent, coating, binder, or other material provided that the manufacturer can demonstrate that during any reasonably foreseeable use, handling, storage, disposal, processing, or transportation, no airborne concentrations of fibers of asbestos in excess of the action level and/or excursion limit will be released or (ii) Asbestos is present in a product in concentrations less than 0.1 percent.

(5) "Employee information and training." (i) The employer shall institute a training program for all employees who are exposed to airborne concentrations of asbestos at or above the action level and/or excursion limit and ensure their participation in the program.

(ii) Training shall be provided prior to or at the time of initial assignment and at least annually thereafter.

(iii) The training program shall be conducted in a manner which the employee is able to understand. The employer shall ensure that each employee is informed of the following:

(A) The health effects associated with asbestos exposure;

(B) The relationship between smoking and exposure to asbestos in producing lung cancer:

(C) The quantity, location, manner of use, release, and storage of asbestos, and the specific nature of operations which could result in exposure to asbestos;

(D) The engineering controls and work practices associated with the employee's job assignment;

(E) The specific procedures implemented to protect employees from exposure to asbestos, such as appropriate work practices, emergency and clean-up procedures, and personal protective equipment to be used;

(F) The purpose, proper use, and limitations of respirators and protective clothing;

(G) The purpose and a description of the medical surveillance program required by paragraph (l) of this section;

(H) The content of this standard, including appendices.

(I) The names, addresses and phone numbers of public health organizations which provide information, materials, and/or conduct programs concerning smoking cessation. The employer may distribute the list of such organizations contained in Appendix I, to comply with this requirement.

(J) The requirements for posting signs and affixing labels and the meaning of the required legends for such signs and labels.

(iv) Access to information and training materials.

(A) The employer shall make a copy of this standard and its appendices readily available without cost to all affected employees.

(B) The employer shall provide, upon request, all materials relating to the employee information and training program to the Assistant Secretary and the training program to the Assistant Secretary and the Director.

(C) The employer shall inform all employees concerning the availability of self-help smoking cessation program material. Upon employee request, the employer shall distribute such material, consisting of NIH Publication No. 89-1647, or equivalent self-help material, which is approved or published by a public health organization listed in appendix I.

(k) "Housekeeping." (1) All surfaces shall be maintained as free as practicable of accumulations of dusts and waste containing asbestos.

(2) All spills and sudden releases of material containing asbestos shall be cleaned up as soon as possible.

(3) Surfaces contaminated with asbestos may not be cleaned by the use of compressed air.

(4) Vacuuming. HEPA-filtered vacuuming equipment shall be used for vacuuming. The equipment shall be used and emptied in a manner which minimizes the reentry of asbestos into the workplace.

(5) Shoveling, dry sweeping and dry clean-up of asbestos may be used only where vacuuming and/or wet cleaning are not feasible.

(6) Waste disposal. Waste, scrap, debris, bags, containers, equipment, and clothing contaminated with asbestos consigned for disposal, shall be collected and disposed of in sealed impermeable bags, or other closed, impermeable containers.

(l) "Medical surveillance" - (1) "General." (i) The employer shall institute a medical surveillance program for all employees who are or will be exposed to airborne concentrations of asbestos at or above the action level and/or excursion limit.

(ii) "Examination by a physician." (A) The employer shall ensure that all medical examinations and procedures are performed by or under the supervision of a licensed physician, and shall be provided without cost to the employee and at a reasonable time and place.

(B) Persons other than licensed physicians, who administer the pulmonary function testing required by this section, shall complete a training course in spirometry sponsored by an appropriate academic or professional institution.

(2) "Preplacement examinations." (i) Before an employee is assigned to an occupation exposed to airborne concentrations of asbestos fibers, a preplacement medical examination shall be provided or made available by the employer.

(ii) Such examination shall include, as a minimum, a medical and work history; a complete physical examination of all systems with emphasis on the respiratory system, the cardiovascular system and digestive tract; completion of the respiratory disease standardized questionnaire in Appendix D, Part 1; a chest roentgenogram (posterior-anterior 14 x 17 inches); pulmonary function tests to include forced vital capacity (FVC) and forced expiratory volume at 1 second (FEV(1.0)); and any additional tests deemed appropriate by the examining physician. Interpretation and classification of chest roentgenograms shall be conducted in accordance with Appendix E.

(3) "Periodic examinations." (i) Periodic medical examinations shall be made available annually.

(ii) The scope of the medical examination shall be in conformance with the protocol established in paragraph (l)(2)(ii) of this section, except that the frequency of chest roentgenograms shall be conducted in accordance with Table 2, and the abbreviated standardized questionnaire contained in Appendix D, Part 2, shall be administered to the employee.

TABLE 2 - FREQUENCY OF CHEST ROENTGENOGRAMS
Years since	Age of employee
first
exposure	15 to 35	35+ to 45	45+

0 to 10	Every 5 years	Every 5 years	Every 5 years
10+	Every 5 years	Every 2 years	Every 1 year

(4) "Termination of employment examinations." (i) The employer shall provide, or make available, a termination of employment medical examination for any employee who has been exposed to airborne concentrations of fibers of asbestos at or above the action level and/or excursion limit.

(ii) The medical examination shall be in accordance with the requirements of the periodic examinations stipulated in paragraph (l)(3) of this section, and shall be given within 30 calendar days before or after the date of termination of employment.

(5) "Recent examinations." No medical examination is required of any employee, if adequate records show that the employee has been examined in accordance with any of the preceding paragraphs [(l)(2)-(l)(4)] within the past 1 year period.

(6) "Information provided to the physician." The employer shall provide the following information to the examining physician:

(i) A copy of this standard and Appendices D and E.

(ii) A description of the affected employee's duties as they relate to the employee's exposure.

(iii) The employee's representative exposure level or anticipated exposure level.

(iv) A description of any personal protective and respiratory equipment used or to be used.

(v) Information from previous medical examinations of the affected employee that is not otherwise available to the examining physician.

(7) "Physician's written opinion." (i) The employer shall obtain a written signed opinion from the examining physician. This written opinion shall contain the results of the medical examination and shall include:

(A) The physician's opinion as to whether the employee has any detected medical conditions that would place the employee at an increased risk of material health impairment from exposure to asbestos;

(B) Any recommended limitations on the employee or upon the use of personal protective equipment such as clothing or respirators; and

(C) A statement that the employee has been informed by the physician of the results of the medical examination and of any medical conditions resulting from asbestos exposure that require further explanation or treatment.

(D) A statement that the employee has been informed by the physician of the increased risk of lung cancer attributable to the combined effect of smoking and asbestos exposure.

(ii) The employer shall instruct the physician not to reveal in the written opinion given to the employer specific findings or diagnoses unrelated to occupational exposure to asbestos.

(iii) The employer shall provide a copy of the physician's written opinion to the affected employee within 30 days from its receipt.

(m) "Recordkeeping" - (1) "Exposure measurements." (i) The employer shall keep an accurate record of all measurements taken to monitor employee exposure to asbestos as prescribed in paragraph (d) of this section.

(ii) This record shall include at least the following information:

(A) The date of measurement;

(B) The operation involving exposure to asbestos which is being monitored;

(D) Number, duration, and results of samples taken;

(E) Type of respiratory protective devices worn, if any; and

(F) Name, social security number and exposure of the employees whose exposure are represented.

(iii) The employer shall maintain this record for at least thirty (30) years, in accordance with 29 CFR 1915.1120.

(2) "Objective data for exempted operations." (i) Where the processing, use, or handling of products made from or containing asbestos is exempted from other requirements of this section under paragraph (d)(2)(iii) of this section, the employer shall establish and maintain an accurate record of objective data reasonably relied upon in support of the exemption.

(ii) The record shall include at least the following:

(A) The product qualifying for exemption;

(B) The source of the objective data;

(D) A description of the operation exempted and how the data support the exemption; and

(E) Other data relevant to the operations, materials, processing, or employee exposures covered by the exemption.

(iii) The employer shall maintain this record for the duration of the employer's reliance upon such objective data.

Note: The employer may utilize the services of competent organizations such as industry trade associations and employee associations to maintain the records required by this section.

(3) "Medical surveillance." (i) The employer shall establish and maintain an accurate record for each employee subject to medical surveillance by paragraph (l)(1)(i) of this section, in accordance with 29 CFR 1915.1120.

(ii) The record shall include at least the following information:

(A) The name and social security number of the employee;

(B) Physician's written opinions;

(D) A copy of the information provided to the physician as required by paragraph (l)(6) of this section.

(iii) The employer shall ensure that this record is maintained for the duration of employment plus thirty (30) years, in accordance with 29 CFR 1915.1120.

(4) "Training." The employer shall maintain all employee training records for one (1) year beyond the last date of employment of that employee.

(5) "Availability." (i) The employer, upon written request, shall make all records required to be maintained by this section available to the Assistant Secretary and the Director for examination and copying.

(ii) The employer, upon request shall make any exposure records required by paragraph (m)(1) of this section available for examination and copying to affected employees, former employees, designated representatives and the Assistant Secretary, in accordance with 29 CFR 1915.1120 (a)-(e) and (g)-(i).

(iii) The employer, upon request, shall make employee medical records required by paragraph (m)(2) of this section available for examination and copying to the subject employee, to anyone having the specific written consent of the subject employee, and the Assistant Secretary, in accordance with 29 CFR 1915.1120.

(6) "Transfer of records." (i) The employer shall comply with the requirements concerning transfer of records set forth in 29 CFR 1915.1120(h).

(ii) Whenever the employer ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, the employer shall notify the Director at least 90 days prior to disposal of records and, upon request, transmit them to the Director.

(n) "Observation of monitoring" - (1) "Employee observation." The employer shall provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to asbestos conducted in accordance with paragraph (d) of this section.

(2) "Observation procedures." When observation of the monitoring of employee exposure to asbestos requires entry into an area where the use of protective clothing or equipment is required, the observer shall be provided with and be required to use such clothing and equipment and shall comply with all other applicable safety and health procedures.

(o) "Dates" - (1) "Effective date." This standard shall become effective July 21, 1986. The requirements in the amended paragraphs in this section which pertain only to or are triggered by the excursion limit shall become effective October 14, 1988.

(2) "Start-up dates." All obligations of this standard commence on the effective date except as follows:

(i) "Exposure monitoring." Initial monitoring required by paragraph (d)(2) of this section shall be completed as soon as possible but no later than October 20, 1986.

(ii) "Regulated areas." Regulated areas required to be established by paragraph (e) of this section as a result of initial monitoring shall be set up as soon as possible after the results of that monitoring are known and not later than November 17, 1986.

(iii) "Respiratory protection." Respiratory protection required by paragraph (g) of this section shall be provided as soon as possible but no later than the following schedule:

(A) Employees whose 8-hour TWA exposure exceeds 2 fibers/cc - July 21, 1986.

(B) Employees whose 8-hour TWA exposure exceeds the PEL but is less than 2 fibers/cc - November 17, 1986.

(iv) "Hygiene and lunchroom facilities." Construction plans for changerooms, showers, lavatories, and lunchroom facilities shall be completed no later than January 16, 1987; and these facilities shall be constructed and in use no later than July 20, 1987. However, if as part of the compliance plan it is predicted by an independent engineering firm that engineering controls and work practices will reduce exposures below the permissible exposure limit by July 20, 1988, for affected employees, then such facilities need not be completed until 1 year after the engineering controls are completed, if such controls have not in fact succeeded in reducing exposure to below the permissible exposure limit.

(v) "Employee information and training." Employee information and training required by paragraph (j)(5) of this section shall be provided as soon as possible but no later than October 20, 1986.

(vi) "Medical surveillance." Medical examinations required by paragraph (l) of this section shall be provided as soon as possible but no later than November 17, 1986.

(vii) "Compliance program." Written compliance programs required by paragraph (f)(2) of this section as a result of initial monitoring shall be completed and available for inspection and copying as soon as possible but no later than July 20, 1987.

(viii) "Methods of compliance." The engineering and work practice controls as required by paragraph (f)(1) shall be implemented as soon as possible but no later than July 20, 1988.

(3) "Start-up dates for excursion limit." Compliance with the excursion limit requirements in this section shall be as follows:

(i) Paragraphs (c), (d), (e), (g), (h), (j), (k), (l), (m) of this section, shall be complied with by December 13, 1988.

(ii) Paragraph (f) of this section, shall be complied with by March 13, 1989.

(iii) Paragraph (i) of this section, shall be complied with by September 14, 1989.

(4) "Compliance date." The requirements of paragraphs (i)(4), (j)(l)(iv), (j)(5)(iii)(I), (j)(5)(iii)(J), (j)(5)(iv)(C), and (l)(7)(i)(D) shall be complied with by May 7, 1990.

(p) "Appendices." (1) Appendices A, C, D, and E to this section are incorporated as part of this section and the contents of these Appendices are mandatory.

(2) Appendices B, F, G, H, and I to this section are informational and are not intended to create any additional obligation not otherwise imposed or to detract from any existing obligation.

[58 FR 35525, July 1, 1993]

1915.1001 App A OSHA Reference Method - Mandatory

This mandatory appendix specifies the procedure for analyzing air samples for asbestos and specifies quality control procedures that must be implemented by laboratories performing the analysis. The sampling and analytical methods described below represent the elements of the available monitoring methods (such as the NIOSH 7400 method) which OSHA considers to be essential to achieve adequate employee exposure monitoring while allowing employers to use methods that are already established within their organizations. All employers who are required to conduct air monitoring under paragraph (d) of the standard are required to utilize analytical laboratories that use this procedure, or an equivalent method, for collecting and analyzing samples.

"Sampling and Analytical Procedure"

1. The sampling medium for air samples shall be mixed cellulose ester filter membranes. These shall be designated by the manufacturer as suitable for asbestos counting. See below for rejection of blanks.

2. The preferred collection device shall be the 25-mm diameter cassette with an open-faced 50-mm electrically conductive extension cowl. The 37-mm cassette may be used if necessary but only if written justification for the need to use the 37-mm filter cassette accompanies the sample results in the employee's exposure monitoring record.

3. An air flow rate between 0.5 liter/min and 2.5 liters/min shall be selected for the 25-mm cassette. If the 37-mm cassette is used, an air flow rate between 1 liter/min and 2.5 liters/min shall be selected.

4. Where possible, a sufficient air volume for each air sample shall be collected to yield between 100 and 1,300 fibers per square millimeter on the membrane filter. If a filter darkens in appearance or if loose dust is seen on the filter, a second sample shall be started.

5. Ship the samples in a rigid container with sufficient packing material to prevent dislodging the collected fibers. Packing material that has a high electrostatic charge on its surface (e.g., expanded polystyrene) cannot be used because such material can cause loss of fibers to the sides of the cassette.

6. Calibrate each personal sampling pump before and after use with a representative filter cassette installed between the pump and the calibration devices.

7. Personal samples shall be taken in the "breathing zone" of the employee (i.e., attached to or near the collar or lapel near the worker's face).

8. Fiber counts shall be made by positive phase contrast using a microscope with an 8 to 10 X eyepiece and a 40 to 45 X objective for a total magnification of approximately 400 X and a numerical aperture of 0.65 to 0.75. The microscope shall also be fitted with a green or blue filter.

9. The microscope shall be fitted with a Walton-Beckett eyepiece graticule calibrated for a field diameter of 100 micrometers (+/- 2 micrometers).

10. The phase-shift detection limit of the microscope shall be about 3 degrees measured using the HSE phase shift test slide as outlined below.

a. Place the test slide on the microscope stage and center it under the phase objective.

b. Bring the blocks of grooved lines into focus. Note: The slide consists of seven sets of grooved lines (ca. 20 grooves to each block) in descending order of visibility from sets 1 to 7, seven being the least visible. The requirements for asbestos counting are that the microscope optics must resolve the grooved lines in set 3 completely, although they may appear somewhat faint, and that the grooved lines in sets 6 and 7 must be invisible. Sets 4 and 5 must be at least partially visible but may vary slightly in visibility between microscopes. A microscope that fails to meet these requirements has either too low or too high a resolution to be used for asbestos counting.

c. If the image deteriorates, clean and adjust the microscope optics. If the problem persists, consult the microscope manufacturer.

11. Each set of samples taken will include 10 percent blanks or a minimum of 2 blanks. The blank results shall be averaged and subtracted from the analytical results before reporting. Any samples represented by a blank having a fiber count in excess of 7 fibers/100 fields shall be rejected.

12. The samples shall be mounted by the acetone/triacetin method or a method with an equivalent index of refraction and similar clarity.

13. Observe the following counting rules. a. Count only fibers equal to or longer than 5 micrometers. Measure the length of curved fibers along the curve.

b. In the absence of other information, count all particles as asbesto that have a length-to-width ratio (aspect ratio) of 3:1 or greater.

c. Fibers lying entirely within the boundary of the Walton-Beckett graticule field shall receive a count of 1. Fibers crossing the boundary once, having one end within the circle, shall receive the count of one half (1/2). Do not count any fiber that crosses the graticule boundary more than once. Reject and do not count any other fibers even though they may be visible outside the graticule area.

d. Count bundles of fibers as one fiber unless individual fibers can be identified by observing both ends of an individual fiber.

e. Count enough graticule fields to yield 100 fibers. Count a minimum of 20 fields; stop counting at 100 fields regardless of fiber count.

14. Blind recounts shall be conducted at the rate of 10 percent.

"Quality Control Procedures"

1. Intralaboratory program. Each laboratory and/or each company with more than one microscopist counting slides shall establish a statistically designed quality assurance program involving blind recounts and comparisons between microscopists to monitor the variability of counting by each microscopist and between microscopists. In a company with more than one laboratory, the program shall include all laboratories and shall also evaluate the laboratory-to-laboratory variability.

2. Interlaboratory program. Each laboratory analyzing asbestos samples for compliance determination shall implement an interlaboratory quality assurance program that as a minimum includes participation of at least two other independent laboratories. Each laboratory shall participate in round robin testing at least once every 6 months with at least all the other laboratories in its interlaboratory quality assurance group. Each laboratory shall submit slides typical of its own work load for use in this program. The round robin shall be designed and results analyzed using appropriate statistical methodology.

3. All individuals performing asbestos analysis must have taken the NIOSH course for sampling and evaluating airborne asbestos dust or an equalivalent course.

4. When the use of different microscopes contributes to differences between counters and laboratories, the effect of the different microscope shall be evaluated and the microscope shall be replaced, as necessary.

5. Current results of these quality assurance programs shall be posted in each laboratory to keep the microscopists informed.

[58 FR 35531, July 1, 1993]

1915.1001 Appendix B Detailed Procedure for Asbestos Sampling and Analysis - Non-Mandatory

This appendix contains a detailed procedure for sampling and analysis and includes those critical elements specified in Appendix A. Employers are not required to use this procedure, but they are required to use Appendix A. The purpose of Appendix B is to provide a detailed step-by-step sampling and analysis procedure that conforms to the elements specified in Appendix A. Since this procedure may also standardize the analysis and reduce variability, OSHA encourages employers to use this appendix.

"Asbestos Sampling and Analysis Method"

Technique: Microscopy, Phase Contrast Analyte: Fibers (manual count) Sample Preparation: Acetone/triacetin method Calibration: Phase-shift detection limit about 3 degrees Range: 100 to 1300 fibers/mm(2) filter area Estimated limit of detection: 7 fibers/mm(2) filter area Sampler: Filter (0.8-1.2 um mixed cellulose ester membrane, 25-mm diameter) Flow rate: 0.5 L/min to 2.5 L/min (25-mm cassette) 1.0 L/min to 2.5 L/min (37-mm cassette) Sample volume: Adjust to obtain 100 to 1300 fibers/mm(2) Shipment: Routine Sample stability: Indefinite Blanks: 10 percent of samples (minimum 2) Standard analytical error: 0.25.

Applicability: The working range is 0.02 f/cc (1920-L air sample) to 1.25 f/cc (400-L air sample). The method gives an index of airborne asbestos fibers but may be used for other materials such as fibrous glass by inserting suitable parameters into the counting rules. The method does not differentiate between asbestos and other fibers. Asbestos fibers less than ca. 0.25 um diameter will not be detected by this method.

Interferences: Any other airborne fiber may interfere since all particles meeting the counting criteria are counted. Chainlike particles may appear fibrous. High levels of nonfibrous dust particles may obscure fibers in the field of view and raise the detection limit.

Reagents: 1. Acetone. 2. Triacetin (glycerol triacetate), reagent grade Special precautions: Acetone is an extremely flammable liquid and precautions must be taken not to ignite it. Heating of acetone must be done in a ventilated laboratory fume hood using a flameless, spark-free heat source.

Equipment: 1. Collection device: 25-mm cassette with 50-mm electrically conductive extension cowl with cellulose ester filter, 0.8 to 1.2 mm pore size and backup pad.

Note: Analyze representative filters for fiber background before use and discard the filter lot if more than 5 fibers/100 fields are found.

2. Personal sampling pump, greater than or equal to 0.5 L/min. with flexible connecting tubing.

3. Microscope, phase contrast, with green or blue filter, 8 to 10X eyepiece, and 40 to 45X phase objective (total magnification ca 400X; numerical aperture = 0.65 to 0.75.

4. Slides, glass, single-frosted, pre-cleaned, 25 x 75 mm.

5. Cover slips, 25 x 25 mm, no. 1 1/2 unless otherwise specified by microscope manufacturer.

6. Knife, No. 1 surgical steel, curved blade.

7. Tweezers.

8. Flask, Guth-type, insulated neck, 250 to 500 mL (with single-holed rubber stopper and elbow-jointed glass tubing, 16 to 22 cm long).

9. Hotplate, spark-free, stirring type; heating mantle; or infrared lamp and magnetic stirrer.

10. Syringe, hypodermic, with 22-gauge needle.

11. Graticule, Walton-Beckett type with 100 um diameter circular field at the specimen plane (area = 0.00785 mm(2)). (Type G-22).

Note: the graticule is custom-made for each microscope.

12. HSE/NPL phase contrast test slide, Mark II.

13. Telescope, ocular phase-ring centering.

14. Stage micrometer (0.01 mm divisions).

Sampling

1. Calibrate each personal sampling pump with a representative sampler in line.

2. Fasten the sampler to the worker's lapel as close as possible to the worker's mouth. Remove the top cover from the end of the cowl extension (open face) and orient face down. Wrap the joint between the extender and the monitor's body with shrink tape to prevent air leaks.

3. Submit at least two blanks (or 10 percent of the total samples, whichever is greater) for each set of samples. Remove the caps from the field blank cassettes and store the caps and cassettes in a clean area (bag or box) during the sampling period. Replace the caps in the cassettes when sampling is completed.

4. Sample at 0.5 L/min or greater. Do not exceed 1 mg total dust loading on the filter. Adjust sampling flow rate, Q (L/min), and time to produce a fiber density, E (fibers/mm(2)), of 100 to 1300 fibers/m(2) [3.85 X 10(4) to 5 X 10(5) fibers per 25-mm filter with effective collection area (A(c)=385 mm(2))] for optimum counting precision (see step 21 below). Calculate the minimum sampling time, t(minimum) (min) at the action level (one-half of the current standard), L (f/cc) of the fibrous aerosol being sampled:

t(minimum)

(Ac)(E)
_____________
(Q)(L)10(3)

5. Remove the field monitor at the end of sampling, replace the plastic top cover and small end caps, and store the monitor.

6. Ship the samples in a rigid container with sufficient packing material to prevent jostling or damage.

Note: Do not use polystyrene foam in the shipping container because of electrostatic forces which may cause fiber loss from the sample filter.

"Sample Preparation"

Note: The object is to produce samples with a smooth (non-grainy) background in a medium with a refractive index equal to or less than 1.46. The method below collapses the filter for easier focusing and produces permanent mounts which are useful for quality control and interlaboratory comparison. Other mounting techniques meeting the above criteria may also be used, e.g., the nonpermanent field mounting technique used in P & CAM 239.

7. Ensure that the glass slides and cover slips are free of dust and fibers.

8. Place 40 to 60 ml of acetone into a Guth-type flask. Stopper the flask with a single-hole rubber stopper through which a glass tube extends 5 to 8 cm into the flask. The portion of the glass tube that exits the top of the stopper (8 to 10 cm) is bent downward in an elbow that makes an angle of 20 to 30 degrees with the horizontal.

9. Place the flask in a stirring hotplate or wrap in a heating mantle. Heat the acetone gradually to its boiling temperature (ca. 58 deg. C).

Caution. - The acetone vapor must be generated in a ventilated fume hood away from all open flames and spark sources. Alternate heating methods can be used, providing no open flame or sparks are present.

10. Mount either the whole sample filter or a wedge cut from the sample filter on a clean glass slide.

a. Cut wedges of ca. 25 percent of the filter area with a curved-blade steel surgical knife using a rocking motion to prevent tearing.

b. Place the filter or wedge, dust side up, on the slide. Static electricity will usually keep the filter on the slide until it is cleared.

c. Hold the glass slide supporting the filter approximately 1 to 2 cm from the glass tube port where the acetone vapor is escaping from the heated flask. The acetone vapor stream should cause a condensation spot on the glass slide ca. 2 to 3 cm in diameter. Move the glass slide gently in the vapor stream. The filter should clear in 2 to 5 § If the filter curls, distorts, or is otherwise rendered unusable, the vapor stream is probably not strong enough. Periodically wipe the outlet port with tissue to prevent liquid acetone dripping onto the filter.

d. Using the hypodermic syringe with a 22-gauge needle, place 1 to 2 drops of triacetin on the filter. Gently lower a clean 25-mm square cover slip down onto the filter at a slight angle to reduce the possibility of forming bubbles. If too many bubbles form or the amount of triacetin is insufficient, the cover slip may become detached within a few hours.

e. Glue the edges of the cover slip to the glass slide using a lacquer or nail polish.

Note: If clearing is slow, the slide preparation may be heated on a hotplate (surface temperature 50 deg. C) for 15 min to hasten clearing. Counting may proceed immediately after clearing and mounting are completed.

Calibration and Quality Control

11. Calibration of the Walton-Beckett graticule. The diameter, d(c)(mm), of the circular counting area and the disc diameter must be specified when ordering the graticule.

a. Insert any available graticule into the eyepiece and focus so that the graticule lines are sharp and clear.

b. Set the appropriate interpupillary distance and, if applicable, reset the binocular head adjustment so that the magnification remains constant.

c. Install the 40 to 45X phase objective.

d. Place a stage micrometer on the microscope object stage and focus the microscope on the graduated lines.

e. Measure the magnified grid length, L(o)(mm), using the stage micrometer.

f. Remove the graticule from the microscope and measure its actual grid length, L(a)(mm). This can best be accomplished by using a stage fitted with verniers.

g. Calculate the circle diameter, d(c)(mm), for the Walton-Beckett graticule:

Example. - If L(o) = 108 um, L(a) = 2.93 mm and D = 100 um, then d(c) = 2.71 mm.

h. Check the field diameter, D(acceptable range 100 mm plus or minus 2 mm) with a stage micrometer upon receipt of the graticule from the manufacturer. Determine field area (mm(2)).

12. Microscope adjustments. Follow the manufacturer's instructions and also the following:

a. Adjust the light source for even illumination across the field of view at the condenser iris.

Note: Kohler illumination is preferred, where available.

b. Focus on the particulate material to be examined.

c. Make sure that the field iris is in focus, centered on the sample, and open only enough to fully illuminate the field of view.

d. Use the telescope ocular supplied by the manufacturer to ensure that the phase rings (annular diaphragm and phase-shifting elements) are concentric.

13. Check the phase-shift detection limit of the microscope periodically.

a. Remove the HSE/NPL phase-contrast test slide from its shipping container and center it under the phase objective.

b. Bring the blocks of grooved lines into focus.

Note: The slide consists of seven sets of grooves (ca. 20 grooves to each block) in descending order of visibility from sets 1 to 7. The requirements for counting are that the microscope optics must resolve the grooved lines in set 3 completely, although they may appear somewhat faint, and that the grooved lines in sets 6 to 7 must be invisible. Sets 4 and 5 must be at least partially visible but may vary slightly in visibility between microscopes. A microscope which fails to meet these requirements has either too low or too high a resolution to be used for asbestos counting.

c. If the image quality deteriorates, clean the microscope optics and, if the problem persists, consult the microscope manufacturer. 14. Quality control of fiber counts.

a. Prepare and count field blanks along with the field samples. Report the counts on each blank. Calculate the mean of the field blank counts and subtract this value from each sample count before reporting the results.

Note 1: The identity of the blank filters should be unknown to the counter until all counts have been completed.

Note 2: If a field blank yields fiber counts greater than 7 fibers/100 fields, report possible contamination of the samples.

b. Perform blind recounts by the same counter on 10 percent of filters counted (slides relabeled by a person other than the counter).

15. Use the following test to determine whether a pair of counts on the same filter should be rejected because of possible bias. This statistic estimates the counting repeatability at the 95 percent confidence level. Discard the sample if the difference between the two counts exceeds 2.77(F)s(r), where F=average of the two fiber counts and s(r)=relative standard deviation, which should be derived by each laboratory based on historical in-house data.

Note: If a pair of counts is rejected as a result of this test, recount the remaining samples in the set and test the new counts against the first counts. Discard all rejected paired counts.

16. Enroll each new counter in a training course that compares performance of counters on a variety of samples using this procedure.

Note: To ensure good reproducibility, all laboratories engaged in asbestos counting are required to participate in the Proficiency Analytical Testing (PAT) Program and should routinely participate with other asbestos fiber counting laboratories in the exchange of field samples to compare performance of counters.

Measurement

17. Place the slide on the mechanical stage of the calibrated microscope with the center of the filter under the objective lens. Focus the microscope on the plane of the filter.

18. Regularly check phase-ring alignment and Kohler illumination.

19. The following are the counting rules: a. Count only fibers longer than 5 um. Measure the length of curved fibers along the curve.

b. Count only fibers with a length-to-width ratio equal to or greater than 3:1.

c. For fibers that cross the boundary of the graticule field, do the following:

1. Count any fiber longer than 5 um that lies entirely within the graticule area.

2. Count as 1/2 fiber any fiber with only one end lying within the graticule area.

3. Do not count any fiber that crosses the graticule boundary more than once.

4. Reject and do not count all other fibers.

d. Count bundles of fibers as one fiber unless individual fibers can be identified by observing both ends of a fiber.

e. Count enough graticule fields to yield 100 fibers. Count a minimum of 20 fields. Stop at 100 fields regardless of fiber count.

20. Start counting from one end of the filter and progress along a radial line to the other end, shift either up or down on the filter, and continue in the reverse direction. Select fields randomly by looking away from the eyepiece briefly while advancing the mechanical stage. When an agglomerate covers ca. 1/6 or more of the field of view, reject the field and select another. Do not report rejected fields in the number of total fields counted.

Note: When counting a field, continuously scan a range of focal planes by moving the fine focus knob to detect very fine fibers which have become embedded in the filter. The small-diameter fibers will be very faint but are an important contribution to the total count.

Calculations

21. Calculate and report fiber density on the filter, E (fibers/mm(2)); by dividing the total fiber count, F; minus the mean field blank count, B, by the number of fields, n; and the field area, A(f)(0.00785 mm(2) for a properly calibrated Walton-Beckett graticule):

d(c)

L(a) X D
________________
l(o)

(F/n(f) - (B/n(b))
________________________
A(f)

fibers/mm(2)

where:

n(f)=number of fields in submission sample n(b)=number of fields in blank sample

22. Calculate the concentration, C (f/cc), of fibers in the air volume sampled, V (L), using the effective collection area of the filter, A(c) (385 mm(2) for a 25-mm filter):

(E)(Ac)
_________________
V(10(3))

Note: Periodically check and adjust the value of A(c), if necessary.

[58 FR 35532, July 1, 1993]

1915.1001 Appendix C Qualitative and Quantitative Fit Testing Procedures - Mandatory

Qualitative Fit Test Protocols

I. "Isoamyl Acetate Protocol."

A. Odor Threshold Screening

1. Three 1-liter glass jars with metal lids (e.g. Mason or Bell jars) are required.

2. Odor-free water (e.g. distilled or spring water) at approximately 25 deg. C shall be used for the solutions.

3. The isoamyl acetate (IAA) (also known as isopentyl acetate) stock solution is prepared by adding 1 cc of pure IAA to 800 cc of odor free water in a 1-liter jar and shaking for 30 seconds. This solution shall be prepared new at least weekly.

4. The screening test shall be conducted in a room separate from the room used for actual fit testing. The two rooms shall be well ventilated but shall not be connected to the same recirculating ventilation system.

5. The odor test solution is prepared in a second jar by placing 0.4 cc of the stock solution into 500 cc of odor free water using a clean dropper or pipette. Shake for 30 seconds and allow to stand for two to three minutes so that the IAA concentration above the liquid may reach equilibrium. This solution may be used for only one day.

6. A test blank is prepared in a third jar by adding 500 cc of odor free water.

7. The odor test and test blank jars shall be labelled 1 and 2 for jar identification. If the labels are put on the lids they can be periodically peeled, dried off and switched to maintain the integrity of the test.

8. The following instructions shall be typed on a card and placed on the table in front of the two test jars (i.e. 1 and 2): "The purpose of this test is to determine if you can smell banana oil at a low concentration. The two bottles in front of you contain water. One of these bottles also contains a small amount of banana oil. Be sure the covers are on tight, then shake each bottle for two seconds. Unscrew the lid of each bottle, one at a time, and sniff at the mouth of the bottle. Indicate to the test conductor which bottle contains banana oil."

9. The mixtures used in the IAA odor detection test shall be prepared in an area separate from where the test is performed, in order to prevent olfactory fatigue in the subject.

10. If the test subject is unable to correctly identify the jar containing the odor test solution, the IAA qualitative fit test may not be used.

11. If the test subject correctly identifies the jar containing the odor test solution, the test subject may proceed to respirator selection and fit testing.

B. Respirator Selection

2. The selection process shall be conducted in a room separate from the fit-test chamber to prevent odor fatigue. Prior to the selection process, the test subject shall be shown how to put on a respirator, how it should be positioned on the face, how to set strap tension and how to determine a "comfortable" respirator. A mirror shall be available to assist the subject in evaluating the fit and positioning of the respirator. This instruction may not constitute the subject's formal training on respirator use, as it is only a review.

3. The test subject should understand that the employee is being asked to select the respirator which provides the most comfortable fit. Each respirator represents a different size and shape and, if fit properly and used properly will provide adequate protection.

4. The test subject holds each facepiece up to the face and eliminates those which obviously do not give a comfortable fit. Normally, selection will begin with a half-mask and if a good fit cannot be found, the subject will be asked to test the full facepiece respirators. (A small percentage of users will not be able to wear any half-mask.) 5. The more comfortable facepieces are noted; the most comfortable mask is donned and worn at least five minutes to assess comfort. All donning and adjustments of the facepiece shall be performed by the test subject without assistance from the test conductor or other person. Assistance in assessing comfort can be given by discussing the points in number 6 below. If the test subject is not familiar with using a particular respirator, the test subject shall be directed to don the mask several times and to adjust the straps each time to become adept at setting proper tension on the straps.

6. Assessment of comfort shall include reviewing the following points with the test subject and allowing the test subject adequate time to determine the comfort of the respirator:

. Positioning of mask on nose.
. Room for eye protection.
. Room to talk.
. Positioning mask on face and cheeks.

7. The following criteria shall be used to help determine the adequacy of the respirator fit:

. Chin properly placed.
. Strap tension.
. Fit across nose bridge.
. Distance from nose to chin.
. Tendency to slip.
. Self-observation in mirror.

8. The test subject shall conduct the conventional negative and positive-pressure fit checks (e.g. see ANSI Z88.2-1980). Before conducting the negative- or positive-pressure test the subject shall be told to "seat" the mask by rapidly moving the head from side-to-side and up and down, while taking a few deep breaths.

9. The test subject is now ready for fit testing.

10. After passing the fit test, the test subject shall be questioned again regarding the comfort of the respirator. If it has become uncomfortable, another model of respirator shall be tried.

11. The employee shall be given the opportunity to select a different facepiece and be retested if the chosen facepiece becomes increasingly uncomfortable at any time.

C. Fit Test

1. The fit test chamber shall be similar to a clear 55 gal drum liner suspended inverted over a 2 foot diameter frame, so that the top of the chamber is about 6 inches above the test subject's head. The inside top center of the chamber shall have a small hook attached.

2. Each respirator used for the fitting and fit testing shall be equipped with organic vapor cartridges or offer protection against organic vapors. The cartridges or masks shall be changed at least weekly.

3. After selecting, donning, and properly adjusting a respirator, the test subject shall wear it to the fit testing room. This room shall be separate from the room used for odor threshold screening and respirator selection, and shall be well ventilated, as by an exhaust fan or lab hood, to prevent general room contamination.

4. A copy of the following test exercises and rainbow passage shall be taped to the inside of the test chamber:

"Test Exercises"

i. Breathe normally.

ii. Breathe deeply. Be certain breaths are "deep" and "regular."

iii. Turn head all the way from one side to the other. Inhale on each side. Be certain movement is complete. Do not bump the respirator against the shoulders.

iv. Nod head up-and-down. Inhale when head is in the full up position (looking toward ceiling). Be certain motions are complete and made about every second. Do not bump the respirator on the chest.

v. Talking. Talk aloud and slowly for several minutes. The following paragraph is called the Rainbow Passage. Reading it will result in a wide range of facial movements, and thus be useful to satisfy this requirement. Alternative passages which serve the same purpose may also be used.

vi. Jogging in place.

vii. Breathe normally.

"Rainbow Passage"

When the sunlight strikes raindrops in the air, they act like a prism and form a rainbow. The rainbow is a division of white light into many beautiful colors. These take the shape of a long round arch, with its path high above, and its two ends apparently beyond the horizon. There is, according to legend, a boiling pot of gold at one end. People look but no one ever finds it. When a man looks for something beyond reach, his friends say he is looking for the pot of gold at the end of the rainbow.

5. Each test subject shall wear the respirator for at least 10 minutes before starting the fit test.

6. Upon entering the test chamber, the test subject shall be given a 6 inch by 5 inch piece of paper towel or other porous absorbent single ply material, folded in half and wetted with three-quarters of one cc of pure IAA. The test subject shall hang the wet towel on the hook at the top of the chamber.

7. Allow two minutes for the IAA test concentration to be reached before starting the fit-test exercises. This would be an appropriate time to talk with the test subject, to explain the fit test, the importance of cooperation, the purpose for the head exercises, or to demonstrate some of the exercises.

8. Each exercise described in number 4 above shall be performed for at least one minute.

9. If at any time during the test, the subject detects the banana-like odor of IAA, the test has failed. The subject shall quickly exit from the test chamber and leave the test area to avoid olfactory fatigue.

10. If the test is failed, the subject shall return to the selection room and remove the respirator, repeat the odor sensitivity test, select and put on another respirator, return to the test chamber, and again begin the procedure described in the c(4) through c(8) above. The process continues until a respirator that fits well has been found. Should the odor sensitivity test be failed, the subject shall wait about 5 minutes before retesting. Odor sensitivity will usually have returned by this time.

11. If a person cannot pass the fit test described above wearing a half-mask respirator from the available selection, full facepiece models must be used.

12. When a respirator is found that passes the test, the subject breaks the faceseal and takes a breath before exiting the chamber. This is to assure that the reason the test subject is not smelling the IAA is the good fit of the respirator facepiece seal and not olfactory fatigue.

13. When the test subject leaves the chamber, the subject shall remove the saturated towel and return it to the person conducting the test. To keep the area from becoming contaminated, the used towels shall be kept in a self-sealing bag so there is no significant IAA concentration buildup in the test chamber during subsequent tests.

14. At least two facepieces shall be selected for the IAA test protocol. The test subject shall be given the opportunity to wear them for one week to choose the one which is more comfortable to wear.

15. Persons who have successfully passed this fit test with a half-mask respirator may be assigned the use of the test respirator in atmospheres with up to 10 times the PEL of airborne asbestos.

16. The test shall not be conducted if there is any hair growth between the skin the facepiece sealing surface.

17. If hair growth or apparel interfere with a satisfactory fit, then they shall be altered or removed so as to eliminate interference and allow a satisfactory fit. If a satisfactory fit is still not attained, the test subject must use a positive-pressure respirator such as powered air-purifying respirators, supplied air respirator, or self-contained breathing apparatus.

18. If a test subject exhibits difficulty in breathing during the tests, she or he shall be referred to a physician trained in respirator diseases or pulmonary medicine to determine whether the test subject can wear a respirator while performing her or his duties.

19. Qualitative fit testing shall be repeated at least every six months.

20. In addition, because the sealing of the respirator may be affected, qualitative fit testing shall be repeated immediately when the test subject has a:

(1) Weight change of 20 pounds or more, (2) Significant facial scarring in the area of the facepiece seal, (3) Significant dental changes; i.e., multiple extractions without prothesis, or acquiring dentures, (4) Reconstructive or cosmetic surgery, or (5) Any other condition that may interfere with facepiece sealing.

D. Recordkeeping

A summary of all test results shall be maintained in each office for 3 years. The summary shall include:

(1) Name of test subject.

(2) Date of testing.

(3) Name of the test conductor.

(4) Respirators selected (indicate manufacturer, model, size and approval number).

(5) Testing agent.

II. "Saccharin Solution Aerosol Protocol"

A. Respirator Selection

Respirators shall be selected as described in section IB (respirator selection) above, except that each respirator shall be equipped with a particulate filter.

B. Taste Threshold Screening

1. An enclosure about head and shoulders shall be used for threshold screening (to determine if the individual can taste saccharin) and for fit testing. The enclosure shall be approximately 12 inches in diameter by 14 inches tall with at least the front clear to allow free movement of the head when a respirator is worn.

2. The test enclosure shall have a three-quarter inch hole in front of the test subject's nose and mouth area to accommodate the nebulizer nozzle.

3. The entire screening and testing procedure shall be explained to the test subject prior to conducting the screening test.

4. During the threshold screening test, the test subject shall don the test enclosure and breathe with open mouth with tongue extended.

5. Using a DeVilbiss Model 40 Inhalation Medication Nebulizer or equivalent, the test conductor shall spray the threshold check solution into the enclosure. This nebulizer shall be clearly marked to distinguish it from the fit test solution nebulizer.

6. The threshold check solution consists of 0.83 grams of sodium saccharin, USP in water. It can be prepared by putting 1 cc of the test solution (see C 7 below) in 100 cc of water.

7. To produce the aerosol, the nebulizer bulb is firmly squeezed so that it collapses completely, then is released and allowed to fully expand.

8. Ten squeezes of the nebulizer bulb are repeated rapidly and then the test subject is asked whether the saccharin can be tasted.

9. If the first response is negative, ten more squeezes of the nebulizer bulb are repeated rapidly and the test subject is again asked whether the saccharin can be tasted.

10. If the second response is negative ten more squeezes are repeated rapidly and the test subject is again asked whether the saccharin can be tasted.

11. The test conductor will take note of the number of squeezes required to elicit a taste response.

12. If the saccharin is not tasted after 30 squeezes (Step 10), the saccharin fit test cannot be performed on the test subject.

13. If a taste response is elicited, the test subject shall be asked to take note of the taste for reference in the fit test.

14. Correct use of the nebulizer means that approximately 1 cc of liquid is used at a time in the nebulizer body.

15. The nebulizer shall be thoroughly rinsed in water, shaken dry, and refilled at least every four hours.

C. Fit Test

1. The test subject shall don and adjust the respirator without the assistance from any person.

2. The fit test uses the same enclosure described in IIB above.

3. Each test subject shall wear the respirator for at least 10 minutes before starting the fit test.

4. The test subject shall don the enclosure while wearing the respirator selected in section 1B above. This respirator shall be properly adjusted and equipped with a particulate filter.

5. The test subject may not eat, drink (except plain water), or chew gum for 15 minutes before the test.

6. A second DeVilbiss Model 40 Inhalation Medication Nebulizer is used to spray the fit test solution into the enclosure. This nebulizer shall be clearly marked to distinguish it from the screening test solution nebulizer.

7. The fit test solution is prepared by adding 83 grams of sodium saccharin to 100 cc of warm water.

8. As before, the test subject shall breathe with mouth open and tongue extended.

9. The nebulizer is inserted into the hole in the front of the enclosure and the fit test solution is sprayed into the enclosure using the same technique as for the taste threshold screening and the same number of squeezes required to elicit a taste response in the screening. (See B8 through B10 above).

10. After generation of the aerosol read the following instructions to the test subject. The test subject shall perform the exercises for one minute each.

i. Breathe normally.

ii. Breathe deeply. Be certain breaths are "deep" and "regular."

iii. Turn head all the way from "one side to the other." Be certain movement is complete. Inhale on each side. Do not bump the respirator against the shoulders.

iv. Nod head up-and-down. Be certain motions are complete. Inhale when head is in the full up position (when looking toward the ceiling). Do not bump the respirator on the chest.

vi. Jogging in place.

vii. Breathe normally.

"Rainbow Passage"

When the sunlight strikes raindrops in the air, they act like a prism and form a rainbow. The rainbow is a division of white light into many beautiful colors. These take the shape of a long round arch, with its path high above, and its two ends apparently beyond the horizon. There is, according to legend, a boiling pot of gold at one end. People look, but no one ever finds it. When a man looks for something beyond his reach, his friends say he is looking for the pot of gold at the end of the rainbow.

11. At the beginning of each exercise, the aerosol concentration shall be replenished using one-half the number of squeezes as initially described in C9.

12. The test subject shall indicate to the test conductor if at any time during the fit test the taste of saccharin is detected.

13. If the saccharin is detected the fit is deemed unsatisfactory and a different respirator shall be tried.

14. At least two facepieces shall be selected by the saccharin solution aerosol test protocol. The test subject shall be given the opportunity to wear them for one week to choose the one which is more comfortable to wear.

15. Successful completion of the test protocol shall allow the use of the half mask tested respirator in contaminated atmospheres up to 10 times the PEL of asbestos. In other words this protocol may be used to assign protection factors no higher than ten.

16. The test shall not be conducted if there is any hair growth between the skin and the facepiece sealing surface.

19. Qualitative fit testing shall be repeated at least every six months.

20. In addition, because the sealing of the respirator may be affected, qualitative fit testing shall be repeated immediately when the test subject has a:

(1) Weight change of 20 pounds or more, (2) Significant facial scarring in the area of the facepiece seal, (3) Significant dental changes; i.e.; multiple extractions without prothesis, or acquiring dentures, (4) Reconstructive or cosmetic surgery, or (5) Any other condition that may interfere with facepiece sealing.

D. Recordkeeping

A summary of all test results shall be maintained in each office for 3 years. The summary shall include:

(1) Name of test subject.

(2) Date of testing.

(3) Name of test conductor.

(4) Respirators selected (indicate manufacturer, model, size and approval number).

(5) Testing agent.

III. "Irritant Fume Protocol"

A. Respirator selection

Respirators shall be selected as described in section IB above, except that each respirator shall be equipped with a high-efficiency cartridge.

B. Fit test

1. The test subject shall be allowed to smell a weak concentration of the irritant smoke to familiarize the subject with the characteristic odor.

2. The test subject shall properly don the respirator selected as above, and wear it for at least 10 minutes before starting the fit test.

3. The test conductor shall review this protocol with the test subject before testing.

4. The test subject shall perform the conventional positive pressure and negative pressure fit checks (see ANSI Z88.2 1980). Failure of either check shall be cause to select an alternate respirator.

5. Break both ends of a ventilation smoke tube containing stannic oxychloride, such as the MSA part number 5645, or equivalent. Attach a short length of tubing to one end of the smoke tube. Attach the other end of the smoke tube to a low pressure air pump set to deliver 200 milliliters per minute.

6. Advise the test subject that the smoke can be irritating to the eyes and instruct the subject to keep the eyes closed while the test is performed.

7. The test conductor shall direct the stream of irritant smoke from the tube towards the faceseal area of the test subject. The person conducting the test shall begin with the tube at least 12 inches from the facepiece and gradually move to within one inch, moving around the whole perimeter of the mask.

8. The test subject shall be instructed to do the following exercises while the respirator is being challenged by the smoke. Each exercise shall be performed for one minute.

i. Breathe normally.

ii. Breathe deeply. Be certain breaths are "deep" and "regular."

iii. Turn head all the way from one side to the other. Be certain movement is complete. Inhale on each side. Do not bump the respirator against the shoulders.

iv. Nod head up-and-down. Be certain motions are complete and made every second. Inhale when head is in the full up position (looking toward ceiling). Do not bump the respirator against the chest.

v. Talking. Talk aloud and slowly for several minutes. The following paragraph is called the Rainbow Passage. Repeating it after the test conductor (keeping eyes closed) will result in a wide range of facial movements, and thus be useful to satisfy this requirement. Alternative passages which serve the same purpose may also be used.

"Rainbow Passage"

When the sunlight strikes raindrops in the air, they act like a prism and form a rainbow. The rainbow is a division of white light into many beautiful colors. These take the shape of a long round arch, with its path high above, and its two ends apparently beyond the horizon. There is, according to legend, a boiling pot of gold at one end. People look, but no one ever finds it. When a man looks for something beyond his reach, his friends say he is looking for the pot of gold at the end of the rainbow.

vi. Jogging in Place.

vii. Breathe normally.

9. The test subject shall indicate to the test conductor if the irritant smoke is detected. If smoke is detected, the test conductor shall stop the test. In this case, the tested respirator is rejected and another respirator shall be selected.

10. Each test subject passing the smoke test (i.e. without detecting the smoke) shall be given a sensitivity check of smoke from the same tube to determine if the test subject reacts to the smoke. Failure to evoke a response shall void the fit test.

11. Steps B4, B9, B10 of this fit test protocol shall be performed in a location with exhaust ventilation sufficient to prevent general contamination of the testing area by the test agents.

12. At least two facepieces shall be selected by the irritant fume test protocol. The test subject shall be given the opportunity to wear them for one week to choose the one which is more comfortable to wear.

13. Respirators successfully tested by the protocol may be used in contaminated atmospheres up to ten times the PEL of asbestos.

14. The test shall not be conducted if there is any hair growth between the skin and the facepiece sealing surface.

15. If hair growth or apparel interfere with a satisfactory fit, then they shall be altered or removed so as to eliminate interference and allow a satisfactory fit. If a satisfactory fit is still not attained, the test subject must use a positive-pressure respirator such as powered air-purifying respirators, supplied air respirator, or self-contained breathing apparatus.

16. If a test subject exhibits difficulty in breathing during the tests, she or he shall be referred to a physician trained in respirator diseases or pulmonary medicine to determine whether the test subject can wear a respirator while performing her or his duties.

17. Qualitative fit testing shall be repeated at least every six months.

18. In addition, because the sealing of the respirator may be affected, qualitative fit testing shall be repeated immediately when the test subject has a:

C. Recordkeeping

A summary of all test results shall be maintained in each office for 3 years. The summary shall include:

(1) Name of test subject.

(2) Date of testing.

(3) Name of test conductor.

(4) Respirators selected (indicate manufacturer, model, size and approval number).

(5) Testing agent

"Quantitative Fit Test Procedures"

1. General.

a. The method applies to the negative-pressure nonpowered air-purifying respirators only.

b. The employer shall assign one individual who shall assume the full responsibility for implementing the respirator quantitative fit test program.

2. "Definition."

a. "Quantitative Fit Test" means the measurement of the effectiveness of a respirator seal in excluding the ambient atmosphere. The test is performed by dividing the measured concentration of challenge agent in a test chamber by the measured concentration of the challenge agent inside the respirator facepiece when the normal air purifying element has been replaced by an essentially perfect purifying element.

b. "Challenge Agent" means the air contaminant introduced into a test chamber so that its concentration inside and outside the respirator may be compared.

c. "Test Subject" means the person wearing the respirator for quantitative fit testing.

d. "Normal Standing Position" means standing erect and straight with arms down along the sides and looking straight ahead.

e. "Fit Factor" means the ratio of challenge agent concentration outside with respect to the inside of a respirator inlet covering (facepiece or enclosure).

3. "Apparatus."

a. "Instrumentation." Corn oil, sodium chloride or other appropriate aerosol generation, dilution, and measurement systems shall be used for quantitative fit test.

b. "Test chamber." The test chamber shall be large enough to permit all test subjects to freely perform all required exercises without distributing the challenge agent concentration or the measurement apparatus. The test chamber shall be equipped and constructed so that the challenge agent is effectively isolated from the ambient air yet uniform in concentration throughout the chamber.

c. When testing air-purifying respirators, the normal filter or cartridge element shall be replaced with a high-efficiency particulate filter supplied by the same manufacturer.

d. The sampling instrument shall be selected so that a strip chart record may be made of the test showing the rise and fall of challenge agent concentration with each inspiration and expiration at fit factors of at least 2,000.

e. The combination of substitute air-purifying elements (if any), challenge agent, and challenge agent concentration in the test chamber shall be such that the test subject is not exposed in excess of PEL to the challenge agent at any time during the testing process.

f. The sampling port on the test specimen respirator shall be placed and constructed so that there is no detectable leak around the port, a free air flow is allowed into the sampling line at all times and so there is no interference with the fit or performance of the respirator.

g. The test chamber and test set-up shall permit the person administering the test to observe one test subject inside the chamber during the test.

h. The equipment generating the challenge atmosphere shall maintain the concentration of challenge agent constant within a 10 percent variation for the duration of the test.

i. The time lag (interval between an event and its being recorded on the strip chart) of the instrumentation may not exceed 2 seconds.

j. The tubing for the test chamber atmosphere and for the respirator sampling port shall be the same diameter, length and material. It shall be kept as short as possible. The smallest diameter tubing recommended by the manufacturer shall be used.

k. The exhaust flow from the test chamber shall pass through a high-efficiency filter before release to the room.

l. When sodium chloride aerosol is used, the relative humidity inside the test chamber shall not exceed 50 percent.

4. "Procedural Requirements."

a. The fitting of half-mask respirators should be started with those having multiple sizes and a variety of interchangeable cartridges and canisters such as the MSA Comfo II-M, North M. Survivair M, A-O M, or Scott-M. Use either of the tests outlined below to assure that the facepiece is properly adjusted.

(1) "Positive pressure test." With the exhaust port(s) blocked, the negative pressure of slight inhalation should remain constant for several seconds. (2) "Negative pressure test." With the intake port(s) blocked, the negative pressure slight inhalation should remain constant for several seconds.

b. After a facepiece is adjusted, the test subject shall wear the facepiece for at least 5 minutes before conducting a qualitive test by using either of the methods described below and using the exercise regime described in 5.a., b., c., d, and e.

(1) "Isoamyl acetate test." When using organic vapor cartridges, the test subject who can smell the odor should be unable to detect the odor of isoamyl acetate squirted into the air near the most vulnerable portions of the facepiece seal. In a location which is separated from the test area, the test subject shall be instructed to close her/his eyes during the test period. A combination cartridge or canister with organic vapor and high-efficiency filters shall be used when available for the particular mask being tested. The test subject shall be given an opportunity to smell the odor of isoamyl acetate before the test is conducted.

(2) "Irritant fume test." When using high-efficiency filters, the test subject should be unable to detect the odor of irritant fume (stannic chloride or titanium tetrachloride ventilation smoke tubes) squirted into the air near the most vulnerable portions of the facepiece seal. The test subject shall be instructed to close her/his eyes during the test period.

c. The test subject may enter the quantitative testing chamber only if she or he has obtained a satisfactory fit as stated in 4.b. of this Appendix.

d. Before the subject enters the test chamber, a reasonably stable challenge agent concentration shall be measured in the test chamber.

e. Immediately after the subject enters the test chamber, the challenge agent concentration inside the respirator shall be measured to ensure that the peak penetration does not exceed 5 percent for a half-mask and 1 percent for a full facepiece.

f. A stable challenge agent concentration shall be obtained prior to the actual start of testing.

(1) Respirator restraining straps may not be overtightened for testing. The straps shall be adjusted by the wearer to give a reasonably comfortable fit typical of normal use.

5. "Exercise Regime." Prior to entering the test chamber, the test subject shall be given complete instructions as to her/his part in the test procedures. The test subject shall perform the following exercises, in the order given, for each independent test.

a. "Normal Breathing (NB)." In the normal standing position, without talking, the subject shall breathe normally for at least one minute.

b. "Deep Breathing (DB)." In the normal standing position the subject shall do deep breathing for at least one minute pausing so as not to hyperventilate.

c. "Turning head side to side (SS)." Standing in place the subject shall slowly turn his/her head from side between the extreme positions to each side. The head shall be held at each extreme position for at least 5 seconds. Perform for at least three complete cycles.

d. "Moving head up and down (UD)." Standing in place, the subject shall slowly move his/her head up and down between the extreme position straight up and the extreme position straight down. The head shall be held at each extreme position for at least 5 seconds. Perform for at least three complete cycles.

e. "Reading (R)." The test subject (keeping eyes closed) shall repeat after the test conductor the `rainbow passage' at the end of this section. The subject shall talk slowly and aloud so as to be heard clearly by the test conductor or monitor.

f. "Grimace (G)." The test subject shall grimace, smile, frown, and generally contort the face using the facial muscles. Continue for at least 15 seconds.

g. "Bend over and touch toes (B)." The test subject shall bend at the waist and touch toes and return to upright position. Repeat for at least 30 seconds.

h. "Jogging in place (J)." The test subject shall perform jog in place for at least 30 seconds.

i. "Normal Breathing (NB)." Same as exercise a.

"Rainbow Passage"

When the sunlight strikes raindrops in the air, they act like a prism and form a rainbow. The rainbow is a division of white light into many beautiful colors. These take the shape of a long round arch, with its path high above, and its two ends apparently beyond the horizon. There is, according to legend, a boiling pot of gold at one end. People look, but no one ever finds it. When a man looks for something beyond reach, his friends say he is looking for the pot of gold at the end of the rainbow.

6. The test shall be terminated whenever any single peak penetration exceeds 5 percent for half-masks and 1 percent for full facepieces. The test subject may be refitted and retested. If two of the three required tests are terminated, the fit shall be deemed inadequate.

7. "Calculation of Fit Factors."

a. The fit factor determined by the quantitative fit test equals the average concentration inside the respirator.

b. The average test chamber concentration is the arithmetic average of the test chamber concentration at the beginning and of the end of the test.

c. The average peak concentration of the challenge agent inside the respirator shall be the arithmetic average peak concentrations for each of the nine exercises of the test which are computed as the arithmetic average of the peak concentrations found for each breath during the exercise.

d. The average peak concentration for an exercise may be determined graphically if there is not a great variation in the peak concentrations during a single exercise.

8. "Interpretation of Test Results." The fit factor measured by the quantitative fit testing shall be the lowest of the three protection factors resulting from three independent tests.

9. "Other Requirements."

a. The test subject shall not be permitted to wear a half-mask or full facepiece mask if the minimum fit factor of 100 or 1,000, respectively, cannot be obtained. If hair growth or apparel interfere with a satisfactory fit, then they shall be altered or removed so as to eliminate interference and allow a satisfactory fit. If a satisfactory fit is still not attained, the test subject must use a positive-pressure respirator such as powered air-purifying respirators, supplied air respirator, or self-contained breathing apparatus.

b. The test shall not be conducted if there is any hair growth between the skin and the facepiece sealing surface.

c. If a test subject exhibits difficulty in breathing during the tests, she or he shall be referred to a physician trained in respirator diseases or pulmonary medicine to determine whether the test subject can wear a respirator while performing her or his duties.

d. The test subject shall be given the opportunity to wear the assigned respirator for one week. If the respirator does not provide a satisfactory fit during actual use, the test subject may request another QNFT which shall be performed immediately.

e. A respirator fit factor card shall be issued to the test subject with the following information:

(1) Name. (2) Date of fit test. (3) Protection factors obtained through each manufacturer, model and approval number of respirator tested.(4) Name and signature of the person that conducted the test. f. Filters used for qualitative or quantitative fit testing shall be replaced weekly, whenever increased breathing resistance is encountered, or when the test agent has altered the integrity of the filter media. Organic vapor cartridges/canisters shall be replaced daily or sooner if there is any indication of breakthrough by the test agent.

10. In addition, because the sealing of the respirator may be affected, quantitative fit testing shall be repeated immediately when the test subject has a:

(1) Weight change of 20 pounds or more, (2) Significant facial scarring in the area of the facepiece seal, (3) Significant dental changes; i.e., multiple extractions without prothesis, or acquiring dentures.(4) Reconstructive or cosmetic surgery, or (5) Any other condition that may interfere with facepiece sealing.

11. "Recordkeeping." A summary of all test results shall be maintained for 3 years. The summary shall include:

(1) Name of test subject. (2) Date of testing. (3) Name of the test conductor. (4) Fit factors obtained from every respirator tested (indicate manufacturer, model, size and approval number).

[58 FR 35534, July 1, 1993]

1915.1001 Appendix D Medical Questionnaires; Mandatory

This mandatory appendix contains the medical questionnaires that must be administered to all employees who are exposed to asbestos above the action level, and who will therefore be included in their employer's medical surveillance program. Part 1 of the appendix contains the Initial Medical Questionnaire, which must be obtained for all new hires who will be covered by the medical surveillance requirements. Part 2 includes the abbreviated Periodical Medical Questionnaire, which must be administered to all employees who are provided periodic medical examinations under the medical surveillance provisions of the standard.

                             Part 1
               INITIAL MEDICAL QUESTIONNAIRE

1.  NAME ________________________________________________________________

2.  SOCIAL SECURITY NUMBER ___  ___  ___  ___  ___  ___  ___  ___  ___
                            1    2    3    4    5    6    7    8    9

3.  CLOCK NUMBER                          ___  ___  ___  ___  ___  ___
                                          10   11   12   13   14   15

4.  PRESENT OCCUPATION __________________________________________________

5.  PLANT _______________________________________________________________

6.  ADDRESS _____________________________________________________________

7.  _____________________________________________________________________
                                                          (Zip Code)

8.  TELEPHONE NUMBER ____________________________________________________

9.  INTERVIEWER _________________________________________________________

10. DATE _________________________________  ___  ___  ___  ___  ___  ___
                                            16   17   18   19   20   21

11. Date of Birth ________________________  ___  ___  ___  ___  ___  ___
                  Month      Day     Year   22   23   24   25   26   27

12. Place of Birth ______________________________________________________

13. Sex                                 1. Male    ___
                                        2. Female  ___

14. What is your marital status?        1. Single  ___  4. Separated/
                                        2. Married ___      Divorced ___
                                        3. Widowed ___

15. Race                                1. White ___   4. Hispanic ___
                                        2. Black ___   5. Indian   ___
                                        3. Asian ___   6. Other    ___


16.  What is the highest grade completed in school? _____________________
     (For example 12 years is completion of high school)

OCCUPATIONAL HISTORY

17A.  Have you ever worked full time (30 hours     1. Yes ___  2. No ___
      per week or more) for 6 months or more?

      IF YES TO 17A:

  B.  Have you ever worked for a year or more in   1. Yes ___  2. No ___
      any dusty job?                               3. Does Not Apply ___

      Specify job/industry _______________ Total Years Worked __________

      Was dust exposure: 1. Mild  ____  2. Moderate ____  3. Severe ____

  C.  Have you ever been exposed to gas or         1. Yes ___  2. No ___
      chemical fumes in your work?
      Specify job/industry ______________________ Total Years Worked ___

      Was exposure :     1. Mild  ____  2. Moderate ____  3. Severe ____

  D.  What has been your usual occupation or job -- the one you have
      worked at the longest?

      1. Job occupation ________________________________________________

      2. Number of years employed in this occupation ___________________

      3. Position/job title ____________________________________________

      4. Business, field or
industry _______________________________________________________________

(Record on lines the years in which you have worked in any of these
industries, e.g. 1960-1969)

Have you ever worked:                                 YES        NO

  E.   In a mine? .........................          _____      _____

  F.   In a quarry? .......................          _____      _____

  G.   In a foundry? ......................          _____      _____

  H.   In a pottery? ......................          _____      _____

  I.   In a cotton, flax or hemp mill? ....          _____      _____

  J.   With asbestos? .....................          _____      _____

18.  PAST MEDICAL HISTORY
                                                      YES        NO

  A. Do you consider yourself to be in good health?  _____      _____

         If "NO" state reason __________________________________________

  B. Have you any defect of vision? ...............  _____      _____

         If "YES" state nature of defect _______________________________

  C. Have you any hearing defect? .................  _____      _____

         If "YES" state nature of defect ______________________________

  D. Are you suffering from or have you ever suffered from:

     a.  Epilepsy (or fits, seizures, convulsions)?  _____      _____

     b.  Rheumatic fever?                            _____      _____

     c.  Kidney disease?                             _____      _____

     d.  Bladder disease?                            _____      _____

     e.  Diabetes?                                   _____      _____

     f.  Jaundice?                                   _____      _____

19.  CHEST COLDS AND CHEST ILLNESSES

19A. If you get a cold, does it "usually" go to your 1. Yes ___  2. No ___
     chest?  (Usually means more than 1/2 the time)  3. Don't get colds __

20A. During the past 3 years, have you had any chest 1. Yes ___  2. No ___
     illnesses that have kept you off work, indoors at
     home, or in bed?

        IF YES TO 20A:
  B. Did you produce phlegm with any of these chest  1. Yes ___  2. No ___
     illnesses?                                      3. Does Not Apply ___

  C. In the last 3 years, how many such illnesses  Number of illnesses ___
     with (increased) phlegm did you have which    No such illnesses   ___
     lasted a week or more?

21.  Did you have any lung trouble before the age of 1. Yes ___  2. No ___
     16?

22.  Have you ever had any of the following?

     1A.  Attacks of bronchitis?                     1. Yes ___  2. No ___

          IF YES TO 1A:
      B. Was it confirmed by a doctor?               1. Yes ___  2. No ___
                                                     3. Does Not Apply ___

      C. At what age was your first attack?             Age in Years   ___
                                                        Does Not Apply ___

     2A. Pneumonia (include bronchopneumonia)?       1. Yes ___  2. No ___

         IF YES TO 2A:
      B. Was it confirmed by a doctor?               1. Yes ___  2. No ___
                                                     3. Does Not Apply ___

      C. At what age did you first have it?             Age in Years   ___
                                                        Does Not Apply ___

     3A. Hay Fever?                                  1. Yes ___  2. No ___

         IF YES TO 3A:
      B. Was it confirmed by a doctor?               1. Yes ___  2. No ___
                                                     3. Does Not Apply ___

      C. At what age did it start?                      Age in Years   ___
                                                        Does Not Apply ___


23A. Have you ever had chronic bronchitis?           1. Yes ___  2. No ___

         IF YES TO 23A:
  B. Do you still have it?                           1. Yes ___  2. No ___
                                                     3. Does Not Apply ___

  C.  Was it confirmed by a doctor?                  1. Yes ___  2. No ___
                                                     3. Does Not Apply ___

  D. At what age did it start?                          Age in Years   ___
                                                        Does Not Apply ___

24A. Have you ever had emphysema?                    1. Yes ___  2. No ___

          IF YES TO 24A:
  B. Do you still have it?                           1. Yes ___  2. No ___
                                                     3. Does Not Apply ___

  C.  Was it confirmed by a doctor?                  1. Yes ___  2. No ___
                                                     3. Does Not Apply ___

  D. At what age did it start?                          Age in Years   ___
                                                        Does Not Apply ___

  E. If you no longer have it, at what age did it       Age stopped    ___
                                                        Does Not Apply ___

26.  Have you ever had:

  A. Any other chest illness?                        1. Yes ___  2. No ___

        If yes, please specify ___________________________________________

  B. Any chest operations?                           1. Yes ___  2. No ___

        If yes, please specify ___________________________________________

  C. Any chest injuries?                             1. Yes ___  2. No ___

        If yes, please specify ___________________________________________

27A. Has a doctor ever told you that you had heart   1. Yes ___  2. No ___
     trouble?

         IF YES TO 27A:
  B. Have you ever had treatment for heart trouble   1. Yes ___  2. No ___
     in the past 10 years?                           3. Does Not Apply ___

28A. Has a doctor told you that you had high         1. Yes ___  2. No ___
     blood pressure?

         IF YES TO 28A:
  B. Have you had any treatment for high blood       1. Yes ___  2. No ___
     pressure (hypertension) in the past 10 years?   3. Does Not Apply ___

29.  When did you last have your chest X-rayed?  (Year) ___  ___  ___  ___
                                                        25   26   27   28

30.  Where did you last have your chest X-rayed (if known)? ______________

     What was the outcome? _______________________________________________

FAMILY HISTORY

31.  Were either of your natural parents ever told by a doctor that they
     had a chronic lung condition such as:

                             FATHER                     MOTHER
                    1. Yes  2. No  3. Don't    1. Yes  2. No  3. Don't
                                      know                       know

  A. Chronic
     Bronchitis?       ___    ___     ___         ___     ___    ___

  B. Emphysema?        ___    ___     ___         ___     ___    ___

  C. Asthma?           ___    ___     ___         ___     ___    ___

  D. Lung cancer?      ___    ___     ___         ___     ___    ___

  E. Other chest
     conditions        ___    ___     ___         ___     ___    ___

  F. Is parent currently alive?
                       ___    ___     ___         ___     ___    ___

  G. Please Specify    ___ Age if Living          ___ Age if Living
                       ___ Age at Death           ___ Age at Death
                       ___ Don't Know             ___ Don't Know

  H. Please specify cause of death
     ____________________________________     __________________________

COUGH

32A. Do you usually have a cough? (Count             1. Yes ___  2. No ___
     a cough with first smoke or on first
     going out of doors.  Exclude clearing
     of throat.) (If no, skip to question
     32C.)

  B. Do you usually cough as much as 4 to            1. Yes ___  2. No ___
     6 times a day 4 or more days out of
     the week?

  C. Do you usually cough at all on getting          1. Yes ___  2. No ___
     up or first thing in the morning?

  D. Do you usually cough at all during the          1. Yes ___  2. No ___
     rest of the day or at night?

IF YES TO ANY OF ABOVE (32A, B, C, OR D,), ANSWER THE FOLLOWING.  IF NO
TO ALL, CHECK "DOES NOT APPLY" AND SKIP TO NEXT PAGE

  E. Do you usually cough like this on most          1. Yes ___  2. No ___
     days for 3 consecutive months or more           3. Does not apply ___
     during the year?

  F. For how many years have you had the cough?        Number of years ___
                                                       Does not apply  ___

33A. Do you usually bring up phlegm from your        1. Yes ___  2. No ___
     chest?
     (Count phlegm with the first smoke or
     on first going out of doors.  Exclude
     phlegm from the nose.  Count swallowed
     phlegm.)  (If no, skip to 33C)

  B. Do you usually bring up phlegm like this        1. Yes ___  2. No ___
     as much as twice a day 4 or more days
     out of the week?

  C. Do you usually bring up phlegm at all on        1. Yes ___  2. No ___
     getting up or first thing in the morning?


  D. Do you usually bring up phlegm at all on        1. Yes ___  2. No ___
     during the rest of the day or at night?

IF YES TO ANY OF THE ABOVE (33A, B, C, OR D), ANSWER THE FOLLOWING:
IF NO TO ALL, CHECK "DOES NOT APPLY" AND SKIP TO 34A

  E. Do you bring up phlegm like this on most        1. Yes ___  2. No ___
     days for 3 consecutive months or more           3. Does not apply ___
     during the year?

  F. For how many years have you had trouble           Number of years ___
     with phlegm?                                      Does not apply  ___

EPISODES OF COUGH AND PHLEGM

34A. Have you had periods or episodes of             1. Yes ___  2. No ___
     (increased*) cough and phlegm lasting
     for 3 weeks or more each year?
     *(For persons who usually have cough and/or
       phlegm)

     IF YES TO 34A
  B. For how long have you had at least 1 such         Number of years ___
     episode per year?                                 Does not apply  ___

WHEEZING

35A. Does your chest ever sound wheezy or
     whistling
              1. When you have a cold?               1. Yes ___  2. No ___
              2. Occasionally apart from colds?      1. Yes ___  2. No ___
              3. Most days or nights?                1. Yes ___  2. No ___

         IF YES TO 1, 2, or 3 in 35A
  B. For how many years has this been present?         Number of years ___
                                                       Does not apply  ___

36A. Have you ever had an attack of wheezing         1. Yes ___  2. No ___
     that has made you feel short of breath?

         IF YES TO 36A
  B. How old were you when you had your first          Age in years   ___
     such attack?                                      Does not apply ___

  C. Have you had 2 or more such episodes?           1. Yes ___  2. No ___
                                                     3. Does not apply ___

  D. Have you ever required medicine or              1. Yes ___  2. No ___
     treatment for the(se) attack(s)?                3. Does not apply ___

BREATHLESSNESS

37.  If disabled from walking by any condition
     other than heart or lung disease, pleas
     describe and proceed to question 39A.
     Nature of condition(s) ______________________________________________

38A. Are you troubled by shortness of breath when    1. Yes ___  2. No ___
     hurrying on the level or walking up a
     slight hill?

     IF YES TO 38A
  B. Do you have to walk slower than people of       1. Yes ___  2. No ___
     your age on the level because of breath         3. Does not apply ___
     lessness?

  C. Do you ever have to stop for breath when        1. Yes ___  2. No ___
     walking at your own pace on the level?          3. Does not apply ___

  D. Do you ever have to stop for breath             1. Yes ___  2. No ___
     after walking about 100 yards (or               3. Does not apply ___
     after a few minutes) on the level?

  E. Are you too breathless to leave the             1. Yes ___  2. No ___
     house or breathless on dressing or              3. Does not apply ___
     climbing one flight of stairs?

TOBACCO SMOKING

39A. Have you ever smoked cigarettes?  (No           1. Yes ___  2. No ___
     means less than 20 packs of cigarettes
     or 12 oz. of tobacco in a lifetime or less
     than 1 cigarette a day for 1 year.)

     IF YES TO 39A

  B. Do you now smoke cigarettes (as of              1. Yes ___  2. No ___
     one month ago)                                  3. Does not apply ___

  C. How old were you when you first started            Age in years   ___
     regular cigarette smoking?                         Does not apply ___

  D. If you have stopped smoking cigarettes     Age stopped            ___
     completely, how old were you when you      Check if still smoking ___
     stopped?                                   Does not apply         ___

  E. How many cigarettes do you smoke per       Cigarettes per day     ___
     day now?                                   Does not apply         ___

  F. On the average of the entire time you      Cigarettes per day     ___
     smoked, how many cigarettes did you        Does not apply         ___
     smoke per day?

  G. Do or did you inhale the cigarette smoke?  1. Does not apply      ___
                                                2. Not at all          ___
                                                3. Slightly            ___
                                                4. Moderately          ___
                                                5. Deeply              ___

40A. Have you ever smoked a pipe regularly?          1. Yes ___  2. No ___
     (Yes means more than 12 oz. of tobacco
     In a lifetime.)

     IF YES TO 40A:
FOR PERSONS WHO HAVE EVER SMOKED A PIPE

  B. 1. How old were you when you started to
        smoke a pipe regularly?                   Age ___

     2. If you have stopped smoking a pipe        Age stopped         ___
        completely, how old were you when you     Check if still
        stopped?                                  smoking pipe        ___
                                                  Does not apply      ___

   C. On the average over the entire time you  ___ oz. per week (a standard
      smoked a pipe, how much pipe tobacco did     pouch of tobacco
      you smoke per week?                          contains 1 1/2 oz.)
                                               ___ Does not apply

   D. How much pipe tobacco are you smoking now?   oz. per week       ___
                                                   Not currently
                                                   smoking a pipe     ___

   E. Do you or did you inhale the pipe smoke?      1. Never smoked   ___
                                                    2. Not at all     ___
                                                    3. Slightly       ___
                                                    4. Moderately     ___
                                                    5. Deeply         ___

41A. Have you ever smoked cigars regularly?         1. Yes ___  2. No ___
     (Yes means more than 1 cigar a week for a
      year)

     IF YES TO 41A
FOR PERSONS WHO HAVE EVER SMOKED A PIPE

  B. 1. How old were you when you started           Age ___
        smoking cigars regularly?

     2. If you have stopped smoking cigars          Age stopped       ___
        completely, how old were you when           Check if still
        you stopped.                                smoking cigars    ___
                                                    Does not apply    ___

  C. On the average over the entire time you        Cigars per week   ___
     smoked cigars, how many cigars did you         Does not apply    ___
     smoke per week?

  D. How many cigars are you smoking per week       Cigars per week   ___
     now?                                           Check if not
                                                    smoking cigars
                                                    currently         ___

  E. Do or did you inhale the cigar smoke?       1. Never smoked      ___
                                                 2. Not at all        ___
                                                 3. Slightly          ___
                                                 4. Moderately        ___
                                                 5. Deeply            ___

Signature ____________________________   Date _____________________

                          Part 2
                  PERIODIC MEDICAL QUESTIONNAIRE

1.   NAME _______________________________________________________________

2.   SOCIAL SECURITY NUMBER ___  ___  ___  ___  ___  ___  ___    ___  ___
                             1    2    3    4    5    6    7  8  9

3.   CLOCK NUMBER                          ---  ---  ---  ---    ---  ---
                                           10   11   12   13  14 15

4.   PRESENT OCCUPATION __________________________________________________

5.   PLANT ______________________________________________________________

6.   ADDRESS ____________________________________________________________

7.   ____________________________________________________________________
                                                         (Zip Code)

8.   TELEPHONE NUMBER ___________________________________________________

9.   INTERVIEWER  _______________________________________________________

10.  DATE ___________________________  ___   ___   ___   ___     ___  ___
                                       16    17    18    19  20  21

11.  What is your marital status?      1. Single  ___   4. Separated/.
                                       2. Married ___      Divorced ___
                                       3. Widowed ___

12.  OCCUPATIONAL HISTORY

12A. In the past year, did you work    1. Yes ___       2. No ___
     full time (30 hours per week
     or more) for 6 months or more?

     IF YES TO 12A:

12B. In the past year, did you work    1. Yes ___       2. No ___
     in a dusty job?                   3. Does not Apply ___

12C. Was dust exposure:     1. Mild ___   2. Moderate ___  3. Severe ___

12D. In the past year, were you        1. Yes ___       2. No ___
     exposed to gas or chemical
     fumes in your work?

12E. Was exposure:          1. Mild ___   2. Moderate ___  3. Severe ___

12F. In the past year,
     what was your:         1. Job/occupation? _________________________
                            2. Position/job title? _____________________

13.  RECENT MEDICAL HISTORY

13A. Do you consider yourself to
     be in good health?                Yes  ___        No ___

     If NO, state reason ______________________________________________

13B. In the past year, have you
     developed:                                        Yes     No
                                    Epilepsy?          ___    ___
                                    Rheumatic fever?   ___    ___
                                    Kidney disease?    ___    ___
                                    Bladder disease?   ___    ___
                                    Diabetes?          ___    ___
                                    Jaundice?          ___    ___
                                    Cancer?            ___    ___

14.  CHEST COLDS AND CHEST ILLNESSES

14A. If you get a cold, does it "usually" go to your chest?
     (usually means more than 1/2 the time)
                                                  1. Yes ___   2. No ___
                                                  3. Don't get colds ___

15A. During the past year, have you had
     any chest illnesses that have kept you       1. Yes ___   2. No ___
     off work, indoors at home, or in bed?        3. Does Not Apply  ___

     IF YES TO 15A:

15B. Did you produce phlegm with any              1. Yes ___   2. No ___
     of these chest illnesses?                    3. Does Not Apply  ___

15C. In the past year, how many such              Number of illnesses ___
     illnesses with (increased) phlegm            No such illnesses   ___
     did you have which lasted a week
     or more?

16.  RESPIRATORY SYSTEM

     In the past year have you had:

                         Yes or No       Further Comment on Positive
                                                  Answers
     Asthma                _____

     Bronchitis            _____

     Hay Fever             _____

     Other Allergies       _____


                         Yes or No       Further Comment on Positive
                                                  Answers
     Pneumonia             _____

     Tuberculosis          _____

     Chest Surgery         _____

     Other Lung Problems   _____

     Heart Disease         _____

     Do you have:

                         Yes or No       Further Comment on Positive
                                                  Answers

     Frequent colds        _____

     Chronic cough         _____

     Shortness of breath
     when walking or
     climbing one flight
     or stairs             _____

     Do you:

     Wheeze                _____

     Cough up phlegm       _____

     Smoke cigarettes      _____   Packs per day ____  How many years ___


Date __________________    Signature ____________________________________

[58 FR 35538, July 1, 1993]

1915.1001 Appendix E Interpretation and Classification of Chest

Roentgenograms - Mandatory

(a) Chest roentgenograms shall be interpreted and classified in accordance with a professionally accepted Classification system and recorded on an interpretation form following the format of the CDC/NIOSH (M) 2.8 form. As a minimum, the content within the bold lines of this form (items 1 though 4) shall be included. This form is not to be submitted to NIOSH.

(b) Roentgenograms shall be interpreted and classified only by a B-reader, a board eligible/certified radiologist, or an experienced physician with known expertise in pneumoconioses.

(c) All interpreters, whenever interpreting chest roentgenograms made under this section, shall have immediately available for reference a complete set of the ILO-U/C International Classification of Radiographs for Pneumoconioses, 1980.

[58 FR 35551, July 1, 1993]

1915.1001 Appendix F Work Practices and Engineering Controls for Automotive Brake Repair Operations - Non-Mandatory

This appendix is intended as guidance for employers in the automotive brake and clutch repair industry who wish to reduce their employees' asbestos exposures during repair operations to levels below the new standard's action level (0.1 f/cc). OSHA believes that employers in this industry sector are likely to be able to reduce their employees' exposures to asbestos by employing the engineering and work practice controls described in Sections A and B of this appendix. Those employers who choose to use these controls and who achieve exposures below the action level will thus be able to avoid any burden that might be imposed by complying with such requirements as medical surveillance, Recordkeeping, training, respiratory protection, and regulated areas, which are triggered when employee exposures exceed the action level or PEL.

Asbestos exposure in the automotive brake and clutch repair industry occurs primarily during the replacement of clutch plates and brake pads, shoes, and linings. Asbestos fibers may become airborne when an automotive mechanic removes the asbestos-containing residue that has been deposited as brakes and clutches wear. Employee exposures to asbestos occur during the cleaning of the brake drum or clutch housing.

Based on evidence in the rulemaking record (Exs. 84-74, 84-263, 90-148), OSHA believes that employers engaged in brake repair operations who implement any of the work practices and engineering controls described in Sections A and B of this appendix may be able to reduce their employees' exposures to levels below the action level (0.1 fiber/cc). These control methods and the relevant record evidence on these and other methods are described in the following sections.

A. "Enclosed Cylinder/HEPA Vacuum System Method"

The enclosed cylinder-vacuum system used in one of the facilities visited by representatives of the National Institute for Occupational Safety and Health (NIOSH) during a health hazard evaluation of brake repair facilities (Ex. 84-263) consists of three components:

(1) A wheel-shaped cylinder designed to cover and enclose the wheel assembly;

(2) A compressed-air hose and nozzle that fits into a port in the cylinder; and

(3) A HEPA-filtered vacuum used to evacuate airborne dust generated within the cylinder by the compressed air.

To operate the system, the brake assembly is enclosed in a cylinder that has viewing ports to provide visibility and cotton sleeves through which the mechanic can handle the brake assembly parts. The cylinder effectively isolates asbestos dust in the drum from the mechanic's breathing zone. One company manufactures the brake assembly isolation cylinder in two sizes to fit brake drums in the 7-to-12-inch size range common to automobiles and light trucks and the 12-to-19-inch size range common to large commercial vehicles. The cylinder is equipped with built-in compressed-air guns and a connection for a vacuum cleaner equipped with a High Efficiency Particulate Air (HEPA) filter. This type of filter is capable of removing all particles greater than 0.3 microns from the air. When the vacuum cleaner's filter is full, it must be replaced according to the manufacturer's instruction, and appropriate HEPA-filtered dual cartridge respirators should be worn during the process. The filter of the vacuum cleaner is assumed to be contaminated with asbestos fibers and should be handled carefully, wetted with a fine mist of water, placed immediately in a labelled plastic bag, and disposed of properly. When the cylinder is in place around the brake assembly and the HEPA vacuum is connected, compressed air is blown into the cylinder to loosen the residue from the brake assembly parts. The vacuum then evacuates the loosened material from within the cylinder, capturing the airborne material on the HEPA filter.

The HEPA vacuum system can be disconnected from the brake assembly isolation cylinder when the cylinder is not being used. The HEPA vacuum can then be used for clutch facing work, grinding, or other routine cleaning.

B. "Compressed Air/Solvent System Method"

A compressed-air hose fitted at the end with a bottle of solvent can be used to loosen the asbestos-containing residue and to capture the resulting airborne particles in the solvent mist. The mechanic should begin spraying the asbestos-contaminated parts with the solvent at a sufficient distance to ensure that the asbestos particles are not dislodged by the velocity of the solvent spray. After the asbestos particles are thoroughly wetted, the spray may be brought closer to the parts and the parts may be sprayed as necessary to remove grease and other material. The automotive parts sprayed with the mist are then wiped with a rag, which must then be disposed of appropriately. Rags should be placed in a labelled plastic bag or other container while they are still wet. This ensures that the asbestos fibers will not become airborne after the brake and clutch parts have been cleaned. (If cleanup rags are laundered rather than disposed of, they must be washed using methods appropriate for the laundering of asbestos-contaminated materials.) OSHA believes that a variant of this compressed-air/solvent mist process offers advantages over the compressed-air/solvent mist technique discussed above, both in terms of costs and employee protection. The variant involves the use of spray cans filled with any of several solvent cleaners commercially available from auto supply stores. Spray cans of solvent are inexpensive, readily available, and easy to use. These cans will also save time, because no solvent delivery system has to be assembled, i.e., no compressed-air hose/mister ensemble. OSHA believes that a spray can will deliver solvent to the parts to be cleaned with considerably less force than the alternative compressed-air delivery system described above, and will thus generate fewer airborne asbestos fibers than the compressed-air method. The Agency therefore believes that the exposure levels of automotive repair mechanics using the spray can/solvent mist process will be even lower than the exposures reported by NIOSH (Ex. 84-263) for the compressed-air/solvent mist system (0.08 f/cc).

C. "Information on the Effectiveness of Various Control Measures"

The amount of airborne asbestos generated during brake and clutch repair operations depends on the work practices and engineering controls used during the repair or removal activity. Data in the rulemaking record document the 8-hour time-weighted average (TWA(8)) asbestos exposure levels associated with various methods of brake and clutch repair and removal.

NIOSH submitted a report to the record entitled "Health Hazard Evaluation for Automotive Brake Repair" (Ex. 84-263). In addition, Exhibits 84-74 and 90-148 provided exposure data for comparing the airborne concentrations of asbestos generated by the use of various work practices during brake repair operations. These reports present exposure data for brake repair operations involving a variety of controls and work practices, including:

. Use of compressed air to blow out the brake drums;

. Use of a brush, without a wetting agent, to remove the asbestos-containing residue;

. Use of a brush dipped in water or a solvent to remove the asbestos-containing residue;

. Use of an enclosed vacuum cleaning system to capture the asbestos-containing residue; and

. Use of a solvent mixture applied with compressed air to remove the residue.

"Prohibited Methods"

The use of compressed air to blow the asbestos-containing residue off the surface of the brake drum removes the residue effectively but simultaneously produces an airborne cloud of asbestos fibers. According to NIOSH (Ex. 84-263), the peak exposures of mechanics using this technique were as high as 15 fibers/cc, and 8-hour TWA exposures ranged from 0.03 to 0.19 f/cc.

Dr. William J. Nicholson of the Mount Sinai School of Medicine (Ex. 84-74) cited data from Knight and Hickish (1970) that indicated that the concentration of asbestos ranged from 0.84 to 5.35 f/cc over a 60-minute sampling period when compressed air was being used to blow out the asbestos-containing residue from the brake drum. In the same study, a peak concentration of 87 f/cc was measured for a few seconds during brake cleaning performed with compressed air. Rohl et al. (1976) (Ex. 90-148) measured area concentrations (of unspecified duration) within 3-5 feet of operations involving the cleaning of brakes with compressed air and obtained readings ranging from 6.6 to 29.8 f/cc. Because of the high exposure levels that result from cleaning brake and clutch parts using compressed air, OSHA has prohibited this practice in the revised standard.

"Ineffective Methods"

When dry brushing was used to remove the asbestos-containing residue from the brake drums and wheel assemblies, peak exposures measured by NIOSH ranged from 0.61 to 0.81 f/cc, while 8-hour TWA levels were at the new standard's permissible exposure limit (PEL) of 0.2 f/cc (Ex. 84-263). Rohl and his colleagues (Ex. 90-148) collected area samples 1-3 feet from a brake cleaning operation being performed with a dry brush, and measured concentrations ranging from 1.3 to 3.6 f/cc; however, sampling times and TWA concentrations were not presented in the Rohl et al. study.

When a brush wetted with water, gasoline, or Stoddart solvent was used to clean the asbestos-containing residue from the affected parts, exposure levels (8-hour TWAs) measured by NIOSH also exceeded the new 0.2 f/cc PEL, and peak exposures ranged as high as 2.62 f/cc (Ex. 84-263).

"Preferred Methods"

Use of an engineering control system involving a cylinder that completely encloses the brake shoe assembly and a High Efficiency Particulate Air (HEPA) filter-equipped vacuum produced 8-hour TWA employee exposures of 0.01 f/cc and peak exposures ranging from nondetectable to 0.07 f/cc (Ex. 84-263). (Because this system achieved exposure levels below the standard's action level, it is described in detail above.) Data collected by the Mount Sinai Medical Center (Ex. 90-148) for Nilfisk of America, Inc., the manufacturer of the brake assembly enclosure system, showed that for two of three operations sampled, the exposure of mechanics to airborne asbestos fibers was nondetectable. For the third operator sampled by Mt. Sinai researchers, the exposure was 0.5 f/cc, which the authors attributed to asbestos that had contaminated the operator's clothing in the course of previous brake repair operations performed without the enclosed cylinder/vacuum system.

Some automotive repair facilities use a compressed-air hose to apply a solvent mist to remove the asbestos-containing residue from the brake drums before repair. The NIOSH data (Ex. 84-263) indicated that mechanics employing this method experienced exposures (8-hour TWAs) of 0.8 f/cc, with peaks of 0.25 to 0.68 f/cc. This technique, and a variant of it that OSHA believes is both less costly and more effective in reducing employee exposures, is described in greater detail above in Sections A and B.

D. "Summary"

In conclusion, OSHA believes that it is likely that employers in the brake and clutch repair industry will be able to avail themselves of the action level trigger built into the revised standard if they conscientiously employ one of the three control methods described above: the enclosed cylinder/HEPA vacuum system, the compressed air/solvent method, or the spray can/solvent mist system.

[58 FR 35551, July 1, 1993]

1915.1001 App G Substance Technical Information for Asbestos - Non-Mandatory

I. "Substance Identification"

A. Substance: "Asbestos" is the name of a class of magnesium-silicate minerals that occur in fibrous form. Minerals that are included in this group are chrysotile, crocidolite, amosite, tremolite asbestos, anthophyllite asbestos, and actinolite asbestos.

B. Asbestos is used in the manufacture of heat-resistant clothing, automative brake and clutch linings, and a variety of building materials including floor tiles, roofing felts, ceiling tiles, asbestos-cement pipe and sheet, and fire-resistant drywall. Asbestos is also present in pipe and boiler insulation materials, and in sprayed-on materials located on beams, in crawlspaces, and between walls.

C. The potential for a product containing asbestos to release breathable fibers depends on its degree of friability. Friable means that the material can be crumbled with hand pressure and is therefore likely to emit fibers. The fibrous or fluffy sprayed-on materials used for fireproofing, insulation, or sound proofing are considered to be friable, and they readily release airborne fibers if disturbed. Materials such as vinyl-asbestos floor tile or roofing felts are considered nonfriable and generally do not emit airborne fibers unless subjected to sanding or sawing operations. Asbestos-cement pipe or sheet can emit airborne fibers if the materials are cut or sawed, or if they are broken during demolition operations.

D. Permissible exposure: Exposure to airborne asbestos fibers may not exceed 0.2 fibers per cubic centimeter of air (0.2 f/cc) averaged over the 8-hour workday.

II. "Health Hazard Data"

A. Asbestos can cause disabling respiratory disease and various types of cancers if the fibers are inhaled. Inhaling or ingesting fibers from contaminated clothing or skin can also result in these diseases. The symptoms of these diseases generally do not appear for 20 or more years after initial exposure.

B. Exposure to asbestos has been shown to cause lung cancer, mesothelioma, and cancer of the stomach and colon. Mesothelioma is a rare cancer of the thin membrane lining of the chest and abdomen. Symptoms of mesothelioma include shortness of breath, pain in the walls of the chest, and/or abdominal pain.

III. "Respirators and Protective Clothing"

A. Respirators: You are required to wear a respirator when performing tasks that result in asbestos exposure that exceeds the permissible exposure limit (PEL) of 0.2 f/cc. These conditions can occur while your employer is in the process of installing engineering controls to reduce asbestos exposure, or where engineering controls are not feasible to reduce asbestos exposure. Air-purifying respirators equipped with a high-efficiency particulate air (HEPA) filter can be used where airborne asbestos fiber concentrations do not exceed 2 f/cc; otherwise, air-supplied, positive-pressure, full facepiece respirators must be used. Disposable respirators or dust masks are not permitted to be used for asbestos work. For effective protection, respirators must fit your face and head snugly. Your employer is required to conduct fit tests when you are first assigned a respirator and every 6 months thereafter. Respirators should not be loosened or removed in work situations where their use is required.

B. Protective Clothing: You are required to wear protective clothing in work areas where asbestos fiber concentrations exceed the permissible exposure limit (PEL) of 0.2 f/cc to prevent contamination of the skin. Where protective clothing is required, your employer must provide you with clean garments. Unless you are working on a large asbestos removal or demolition project, your employer must also provide a change room and separate lockers for your street clothes and contaminated work clothes. If you are working on a large asbestos removal or demolition project, and where it is feasible to do so, your employer must provide a clean room, shower, and decontamination room contiguous to the work area. When leaving the work area, you must remove contaminated clothing before proceeding to the shower. If the shower is not adjacent to the work area, you must vacuum your clothing before proceeding to the change room and shower. To prevent inhaling fibers in contaminated change rooms and showers, leave your respirator on until you leave the shower and enter the clean change room.

IV. "Disposal Procedures and Cleanup"

A. Wastes that are generated by processes where asbestos is present include:

1. Empty asbestos shipping containers.

2. Process wastes such as cuttings, trimmings, or reject material.

3. Housekeeping waste from sweeping or vacuuming.

4. Asbestos fireproofing or insulating material that is removed from buildings.

5. Building products that contain asbestos removed during building renovation or demolition.

6. Contaminated disposable protective clothing.

B. Empty shipping bags can be flattened under exhaust hoods and packed into airtight containers for disposal. Empty shipping drums are difficult to clean and should be sealed.

C. Vacuum bags or disposable paper filters should not be cleaned, but should be sprayed with a fine water mist and placed into a labeled waste container.

D. Process waste and housekeeping waste should be wetted with water or a mixture of water and surfactant prior to packaging in disposable containers.

E. Material containing asbestos that is removed from buildings must be disposed of in leak-tight 6-mil thick plastic bags, plastic-lined cardboard containers, or plastic-lined metal containers. These wastes, which are removed while wet, should be sealed in containers before they dry out to minimize the release of asbestos fibers during handling.

V. "Access to Information"

A. Each year, your employer is required to inform you of the information contained in this standard and appendices for asbestos. In addition, your employer must instruct you in the proper work practices for handling materials containing asbestos, and the correct use of protective equipment.

B. Your employer is required to determine whether you are being exposed to asbestos. You or your representative has the right to observe employee measurements and to record the results obtained. Your employer is required to inform you of your exposure, and, if you are exposed above the permissible limit, he or she is required to inform you of the actions that are being taken to reduce your exposure to within the permissible limit.

C. Your employer is required to keep records of your exposures and medical examinations. These exposure records must be kept for at least thirty (30) years. Medical records must be kept for the period of your employment plus thirty (30) years.

D. Your employer is required to release your exposure and medical records to your physician or designated representative upon your written request.

[58 FR 35552, July 1, 1993]

1915.1001 Appendix H Medical Surveillance Guidelines for Asbestos Non-Mandatory

I. "Route of Entry Inhalation, Ingestion"

II. "Toxicology"

Clinical evidence of the adverse effects associated with exposure to asbestos is present in the form of several well-conducted epidemiological studies of occupationally exposed workers, family contacts of workers, and persons living near asbestos mines. These studies have shown a definite association between exposure to asbestos and an increased incidence of lung cancer, pleural and peritoneal mesothelioma, gastrointestinal cancer, and asbestoses. The latter is a disabling fibrotic lung disease that is caused only by exposure to asbestos. Exposure to asbestos has also been associated with an increased incidence of esophageal, kidney, laryngeal, pharyngeal, and buccal cavity cancers. As with other known chronic occupational diseases, disease associated with asbestos generally appears about 20 years following the first occurrence of exposure: There are no known acute effects associated with exposure to asbestos.

Epidemiological studies indicate that the risk of lung cancer among exposed workers who smoke cigarettes is greatly increased over the risk of lung cancer among non-exposed smokers or exposed nonsmokers. These studies suggest that cessation of smoking will reduce the risk of lung cancer for a person exposed to asbestos but will not reduce it to the same level of risk as that existing for an exposed worker who has never smoked.

III. "Signs and Symptoms of Exposure-Related Disease"

The signs and symptoms of lung cancer or gastrointestinal cancer induced by exposure to asbestos are not unique, except that a chest X-ray of an exposed patient with lung cancer may show pleural plaques, pleural calcification, or pleural fibrosis. Symptoms characteristic of mesothelioma include shortness of breath, pain in the walls of the chest, or abdominal pain. Mesothelioma has a much longer latency period compared with lung cancer (40 years versus 15-20 years), and mesothelioma is therefore more likely to be found among workers who were first exposed to asbestos at an early age. Mesothelioma is always fatal.

Asbestoses is pulmonary fibrosis caused by the accumulation of asbestos fibers in the lungs. Symptoms include shortness of breath, coughing, fatigue, and vague feelings of sickness. When the fibrosis worsens, shortness of breath occurs even at rest. The diagnosis of asbestoses is based on a history of exposure to asbestos, the presence of characteristic radiologic changes, end-inspiratory crackles (rales), and other clinical features of fibrosing lung disease. Pleural plaques and thickening are observed on X-rays taken during the early stages of the disease. Asbestoses is often a progressive disease even in the absence of continued exposure, although this appears to be a highly individualized characteristic. In severe cases, death may be caused by respiratory or cardiac failure.

IV. "Surveillance and Preventive Considerations"

As noted above, exposure to asbestos has been linked to an increased risk of lung cancer, mesothelioma, gastrointestinal cancer, and asbestoses among occupationally exposed workers. Adequate screening tests to determine an employee's potential for developing serious chronic diseases, such as cancer, from exposure to asbestos do not presently exist. However, some tests, particularly chest X-rays and pulmonary function tests, may indicate that an employee has been overexposed to asbestos increasing his or her risk of developing exposure-related chronic diseases. It is important for the physician to become familiar with the operating conditions in which occupational exposure to asbestos is likely to occur. This is particularly important in evaluating medical and work histories and in conducting physical examinations. When an active employee has been identified as having been overexposed to asbestos, measures taken by the employer to eliminate or mitigate further exposure should also lower the risk of serious long-term consequences.

The employer is required to institute a medical surveillance program for all employees who are or will be exposed to asbestos at or above the action level (0.1 fiber per cubic centimeter of air). All examinations and procedures must be performed by or under the supervision of a licensed physician, at a reasonable time and place, and at no cost to the employee.

Although broad latitude is given to the physician in prescribing specific tests to be included in the medical surveillance program, OSHA requires inclusion of the following elements in the routine examination:

(i) Medical and work histories with special emphasis directed to symptoms of the respiratory system, cardiovascular system, and digestive tract.

(ii) Completion of the respiratory disease questionnaire contained in Appendix D.

(iii) A physical examination including a chest roentgenogram and pulmonary function test that includes measurement of the employee's forced vital capacity (FVC) and forced expiratory volume at one second (FEV(1)).

(iv) Any laboratory or other test that the examining physician deems by sound medical practice to be necessary.

The employer is required to make the prescribed tests available at least annually to those employees covered; more often than specified if recommended by the examining physician; and upon termination of employment.

The employer is required to provide the physician with the following information: A copy of this standard and appendices; a description of the employee's duties as they relate to asbestos exposure; the employee's representative level of exposure to asbestos; a description of any personal protective and respiratory equipment used; and information from previous medical examinations of the affected employee that is not otherwise available to the physician. Making this information available to the physician will aid in the evaluation of the employee's health in relation to assigned duties and fitness to wear personal protective equipment, if required.

The employer is required to obtain a written opinion from the examining physician containing the results of the medical examination; the physician's opinion as to whether the employee has any detected medical conditions that would place the employee at an increased risk of exposure-related disease; any recommended limitations on the employee or on the use of personal protective equipment; and a statement that the employee has been informed by the physician of the results of the medical examination and of any medical conditions related to asbestos exposure that require further explanation or treatment. This written opinion must not reveal specific findings or diagnoses unrelated to exposure to asbestos, and a copy of the opinion must be provided to the affected employee.

[58 FR 35553, July 1, 1993]

1915.1001 Appendix I Smoking Cessation Program Information for Asbestos - Non-Mandatory

The following organizations provide smoking cessation information and program material.

1. The National Cancer Institute operates a toll-free Cancer Information Service (CIS) with trained personnel to help you. Call 1-800-4-CANCER* to reach the CIS office serving your area, or write: Office of Cancer Communications, National Cancer Institute, National Institutes of Health, Building 31, Room 10A24, Bethesda, Maryland 20892.

2. American Cancer Society, 3340 Peachtree Road, NE., Atlanta, Georgia 30062, (404) 320-3333.

The American Cancer Society (ACS) is a voluntary organization composed of 58 divisions and 3,100 local units. Through "The Great American Smokeout" in November, the annual Cancer Crusade in April, and numerous educational materials, ACS helps people learn about the health hazards of smoking and become successful ex-smokers.

3. American Heart Association, 7320 Greenville Avenue, Dallas, Texas 75231, (214) 750-5300.

The American Heart Association (AHA) is a voluntary organization with 130,000 members (physicians, scientists, and laypersons) in 55 state and regional groups. AHA produces a variety of publications and audiovisual materials about the effects of smoking on the heart. AHA also has developed a guidebook for incorporating a weight-control component into smoking cessation programs.

4. American Lung Association, 1740 Broadway, New York, New York 10019, (212) 245-8000.

A voluntary organization of 7,500 members (physicians, nurses, and laypersons), the American Lung Association (ALA) conducts numerous public information programs about the health effect of smoking. ALA has 59 state and 85 local units. The organization actively supports legislation and information campaigns for non-smokers' rights and provides help for smokers who want to quit, for example, through "Freedom From Smoking," a self-help smoking cessation program.

5. Office on Smoking and Health, U.S. Department of Health and, Human Services, 5600 Fishers Lane, Park Building, Room 110, Rockville, Maryland 20857.

The Office on Smoking and Health (OSH) is the Department of Health and Human Services' lead agency in smoking control. OSH has sponsored distribution of publications on smoking-realted topics, such as free flyers on relapse after initial quitting, helping a friend or family member quit smoking, the health hazards of smoking, and the effects of parental smoking on teenagers.

. In Hawaii, on Oahu call 524-1234 (call collect from neighboring islands), Spanish-speaking staff members are available during daytime hours to callers from the following areas: California, Florida, Georgia, Illinois, New Jersey (area code 210), New York, and Texas. Consult your local telephone directory for listings of local chapters.

(Reporting and Recordkeeping requirements in paragraphs (d)(2), (3), (5), and (7), (f)(2) and (3)(i), (j)(5), (l), and (m) as they apply to the excursion limit have been approved by the Office of Management and Budget under control numbers 1218-0133 and 1218-0134. The OMB clearance expires on February 29, 1992.)

(Reporting and Recordkeeping requirements in paragraph (j)(5)(iv)(C) have received OMB paperwork clearance under OMB clearance number 1218-0133. The OMB clearance expires on April 30, 1993.)

(Approved by the Office of Management and Budget under control number 1218-0133)

[58 FR 35553, July 1, 1993]

1915.1002 Coal tar pitch volatiles; Interpretation of term.

As used in 1915.1000 (Table Z-1), coal tar pitch volatiles include the fused polycyclic hydrocarbons which volatilize from distillation residues of coal, petroleum (excluding asphalt), wood, and other organic matter. Asphalt (CAS 8052-42-4, and CAS 64742-93-4) is not covered under the "coal tar pitch volatiles" standard.

[58 FR 35554, July 1, 1993]

1915.1003 4-Nitrobiphenyl.

(a) "Scope and application." (1) This section applies to any area in which 4-Nitrobiphenyl, Chemical Abstracts Service Registry Number 92933 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 0.1 percent by weight or volume of 4-Nitrobiphenyl.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of 4-Nitrobiphenyl. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving 4-Nitrobiphenyl where containment prevents the release of 4-Nitrobiphenyl into regulated areas, non-regulated areas, or the external environment.

(5) "Decontamination" means the inactivation of 4-Nitrobiphenyl or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of 4-Nitrobiphenyl from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of 4-Nitrobiphenyl which may result in exposure to or contact with 4-Nitrobiphenyl.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of 4-Nitrobiphenyl, which is impervious to the passage of 4-Nitrobiphenyl, and which would prevent the entry of 4-Nitrobiphenyl into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving 4-Nitrobiphenyl within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving 4-Nitrobiphenyl in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of 4-Nitrobiphenyl into regulated areas, non-regulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to 4-Nitrobiphenyl.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing 4-Nitrobiphenyl." A regulated area shall be established by an employer where 4-Nitrobiphenyl is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with 4-Nitrobiphenyl within an isolated system such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where 4-Nitrobiphenyl is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while 4-Nitrobiphenyl is contained within: (i) Access shall be restricted to authorized employees only;

(ii) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit and before engaging in other activities.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where 4-Nitrobiphenyl is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(ii) Each operation shall be provided with continuous local exhaust ventilation so that air movement is always from ordinary work areas to the operation. Exhaust air shall not be discharged to regulated areas, nonregulated areas or the external environment unless decontaminated. Clean makeup air shall be introduced in sufficient volume to maintain the correct operation of the local exhaust system.

(iii) Employees shall be provided with, and required to wear, clean, full body protective clothing (smocks, coveralls, or long-sleeved shirt and pants), shoe covers and gloves prior to entering the regulated area.

(iv) Employees engaged in 4-Nitrobiphenyl handling operations shall be provided with and required to wear and use a half-face, filter-type respirator for dusts, mists, and fumes, in accordance with 1910.134. A respirator affording higher levels of protection may be substituted.

(v) Prior to each exit from a regulated area, employees shall be required to remove and leave protective clothing and equipment at the point of exit and at the last exit of the day, to place used clothing and equipment in impervious containers at the point of exit for purposes of decontamination or disposal. The contents of such impervious containers shall be identified, as required under paragraphs (e)(2), (3), and (4) of this section.

(vi) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities.

(vii) Employees shall be required to shower after the last exit of the day.

(viii) Drinking fountains are prohibited in the regulated area.

(5) "Maintenance and decontamination activities." In cleanup of leaks or spills, maintenance or repair operations on contaminated systems or equipment, or any operations involving work in an area where direct contact with 4-Nitrobiphenyl could result, each authorized employee entering that area shall:

(i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(2) "Emergencies." In an emergency, immediate measures including, but not limited to, the requirements of paragraphs (d)(2)(i), (ii), (iii), (iv), and (v) of this section shall be implemented.

(i) The potentially affected area shall be evacuated as soon as the emergency has been determined.

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iii) Special medical surveillance by a physician shall be instituted within 24 hours for employees present in the potentially affected area at the time of the emergency. A report of the medical surveillance and any treatment shall be included in the incident report, in accordance with paragraph (f)(2) of this section.

(iv) Where an employee has a known contact with 4-Nitrobiphenyl such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(3) "Hygiene facilities and practices." (i) Storage or consumption of food, storage or use of containers of beverages, storage or application of cosmetics, smoking, storage of smoking materials, tobacco products or other products for chewing, or the chewing of such products, are prohibited in regulated areas.

(ii) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2) (ii) through (vii).

(iii) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iv) Where employees wear protective clothing and equipment, clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(v) Where toilets are in regulated areas, such toilets shall be in a separate room.

(4) "Contamination control." (i) Regulated areas, except for outdoor systems, shall be maintained under pressure negative with respect to nonregulated areas. Local exhaust ventilation may be used to satisfy this requirement. Clean makeup air in equal volume shall replace air removed.

(ii) Any equipment, material, or other item taken into or removed from a regulated area shall be done so in a manner that does not cause contamination in nonregulated areas or the external environment.

(iii) Decontamination procedures shall be established and implemented to remove 4-Nitrobiphenyl from the surfaces of materials, equipment and the decontamination facility.

(iv) Dry sweeping and dry mopping are prohibited.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS
AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS,
AND AIR-SUPPLIED HOOD REQUIRED AT ALL
TIMES
AUTHORIZED PERSONNEL ONLY

(iii) Appropriate signs and instructions shall be posted at the entrance to, and exit from, regulated areas, informing employees of the procedures that must be followed in entering and leaving a regulated area.

(2) "Container contents identification." (i) Containers of 4-Nitrobiphenyl and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of 4-Nitrobiphenyl and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have 4-Nitrobiphenyl contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(3) "Lettering." Lettering on signs and instructions required by paragraph (e)(1) shall be a minimum letter height of 2 inches (5.08 cm). Labels on containers required under this section shall not be less than 1/2 the size of the largest lettering on the package, and not less than 8 point type in any instance. "Provided," That no such required lettering need be more than 1 inch (2.54 cm) in height.

(4) "Prohibited statements." No statement shall appear on or near any required sign, label, or instruction which contradicts or detracts from the effect of any required warning, information or instruction.

(5) "Training and indoctrination." (i) Each employee prior to being authorized to enter a regulated area, shall receive a training and indoctrination program including, but not necessarily limited to: (A) The nature of the carcinogenic hazards of 4-Nitrobiphenyl, including local and systemic toxicity;

(B) The specific nature of the operation involving 4-Nitrobiphenyl which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of 4-Nitrobiphenyl;

(H) The purpose for and application of specific first aid procedures and practices;

(i) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(f) "Reports" - (1) "Operations." Not later than March 1, 1974, the information required in paragraphs (f)(1)(i), (ii), (iii), and (iv) of this section shall be reported in writing to the nearest OSHA Area Director. Any changes in such information shall be similarly reported in writing within 15 calendar days of such change.

(i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of 4-Nitrobiphenyl in each regulated area.

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which 4-Nitrobiphenyl is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of 4-Nitrobiphenyl into any area where employees may be potentially exposed shall be reported in accordance with this paragraph. (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the nearest OSHA Area Director.

(ii) A written report shall be filed with the nearest OSHA Area Director within 15 calendar days thereafter and shall include: (A) A specification of the amount of material released, the amount of time involved, and an explanation of the procedure used in determining this figure;

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(g) "Medical surveillance." At no cost to the employee, a program of medical surveillance shall be established and implemented for employees considered for assignment to enter regulated areas, and for authorized employees.

(1) "Examinations." (i) Before an employee is assigned to enter a regulated area, a preassignment physical examination by a physician shall be provided. The examination shall include the personal history of the employee, family and occupational background, including genetic and environmental factors.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(iii) In all physical examinations, the examining physician shall consider whether there exist conditions of increased risk, including reduced immunological competence, those undergoing treatment with steroids or cytotoxic agents, pregnancy and cigarette smoking.

(2) "Records." (i) Employers of employees examined pursuant to this paragraph shall cause to be maintained complete and accurate records of all such medical examinations. Records shall be maintained for the duration of the employee's employment. Upon termination of the employee's employment, including retirement or death, or in the event that the employer ceases business without a successor, records, or notarized true copies thereof, shall be forwarded by registered mail to the Director.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120 (a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0085)

[58 FR 35554, July 1, 1993]

1915.1004 alpha-Naphthylamine.

(a) "Scope and application." (1) This section applies to any area in which alpha-Naphthylamine, Chemical Abstracts Service Registry Number 134327 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 1.0 percent by weight or volume of alpha-Naphthylamine.

(3) This section will not apply to operations involving the destructive distillation of carbonaceous materials, such as occurs in coke ovens.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of alpha-Naphthylamine. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving alpha-Naphthylamine where containment prevents the release of alpha-Naphthylamine into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of alpha-Naphthylamine or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of alpha-Naphthylamine from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of alpha-Naphthylamine which may result in exposure to or contact with alpha-Naphthylamine.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of alpha-Naphthylamine, which is impervious to the passage of alpha-Naphthylamine, and which would prevent the entry of alpha-Naphthylamine into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving alpha-Naphthylamine within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving alpha-Naphthylamine in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of alpha-Naphthylamine into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to alpha-Naphthylamine.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing alpha-Naphthylamine." A regulated area shall be established by an employer where alpha-Naphthylamine is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with alpha-Naphthylamine within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where alpha-Naphthylamine is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while alpha-Naphthylamine is contained within: (i) Access shall be restricted to authorized employees only;

(ii) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit and before engaging in other activities.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where alpha-Naphthylamine is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iii) Employees shall be provided with, and required to wear, clean, full body protective clothing (smocks, coveralls, or long-sleeved shirt and pants), and shoe covers and gloves prior to entering a regulated area.

(iv) Employees engaged in alpha-Naphthylamine handling operations shall be provided with and required to wear and use a half-face, filter-type respirator for dusts, mists, and fumes, in accordance with 1910.134. A respirator affording higher levels of protection may be substituted.

(v) Prior to each exit from a regulated area, employees shall be required to remove and leave protective clothing and equipment at the point of exit and at the last exist of the day, to place used clothing and equipment in impervious containers at the point of exit for purposes of decontamination or disposal. The contents of such impervious containers shall be identified, as required under paragraphs (e)(2), (3), and (4) of this section.

(vi) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities.

(vii) Employees shall be required to shower after the last exit of the day.

(viii) Drinking fountains are prohibited in the regulated area.

(5) "Maintenance and decontamination activities." In cleanup of leaks or spills, maintenance or repair operations on contaminated systems or equipment, or any operations involving work in an area where direct contact with alpha-Naphthylamine could result, each authorized employee entering that area shall:

(i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(2) "Emergencies." In an emergency, immediate measures including, but not limited to, the requirements of paragraphs (d)(2)(i), (ii), (iii), (iv), and (v) of this section shall be implemented.

(i) The potentially affected area shall be evacuated as soon as the emergency has been determined.

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected areas shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with alpha-Naphthylamine, such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2)(ii) through (vii).

(iii) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iv) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(v) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iii) Decontamination procedures shall be established and implemented to remove alpha-Naphthylamine from the surfaces of materials, equipment and the decontamination facility.

(iv) Dry sweeping and dry mopping are prohibited.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS
AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS,
AND AIR-SUPPLIED HOOD REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of alpha-Naphthylamine and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of alpha-Naphthylamine and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by, employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have alpha-Naphthylamine contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(3) "Lettering." Lettering on signs and instructions required by paragraph (e)(1) of this section shall be a minimum letter height of 2 inches (5.08 cm). Labels on containers required under this section shall not be less than 1/2 the size of the largest lettering on the package, and not less than 8 point type in any instance: "Provided," That no such required lettering need be more than 1 inch (2.54 cm) in height.

(5) "Training and indoctrination." (i) Each employee prior to being authorized to enter a regulated area, shall receive a training and indoctrination program including, but not necessarily limited to: (A) The nature of the carcinogenic hazards of alpha-Naphthylamine, including local and systemic toxicity;

(B) The specific nature of the operation involving alpha-Naphthylamine which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of alpha-Naphthylamine;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of alpha-Naphthylamine in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which alpha-Naphthylamine is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of alpha-Naphthylamine into any area where employees may be potentially exposed shall be reported in accordance with this subparagraph.

(i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the nearest OSHA Area Director.

(ii) A written report shall be filed with the nearest OSHA Area Director within 15 calendar days thereafter and shall include:

(A) A specification of the amount of material released, the amount of time involved, and an explanation of the procedure used in determining this figure;

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0084)

[58 FR 35557, July 1, 1993]

1915.1005 [Reserved]

[Reserved]

1915.1006 Methyl chloromethyl ether.

(a) "Scope and application." (1) This section applies to any area in which methyl chloromethyl ether, Chemical Abstracts Service Registry Number 107302 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 0.1 percent by weight or volume of methyl chloromethyl ether.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of methyl chloromethyl ether. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving methyl chloromethyl ether where containment prevents the release of methyl chloromethyl ether into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of methyl chloromethyl ether or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of methyl chloromethyl ether from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of methyl chloromethyl ether which may result in exposure to or contact with methyl chloromethyl ether.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of methyl chloromethyl ether, which is impervious to the passage of methyl chloromethyl ether, and which would prevent the entry of methyl chloromethyl ether into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving methyl chloromethyl ether within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving methyl chloromethyl ether in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of methyl chloromethyl ether into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to methyl chloromethyl ether.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing methyl chloromethyl ether." A regulated area shall be established by an employer where methyl chloromethyl ether is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with methyl chloromethyl ether within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where methyl chloromethyl ether is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while methyl chloromethyl ether is contained within. Access shall be restricted to authorized employees only.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where methyl chloromethyl ether is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iii) Employees shall be provided with, and required to wear, clean, full body protective clothing (smocks, coveralls, or long-sleeved shirt and pants), and gloves prior to entering the regulated area.

(iv) Employees engaged in methyl chloromethyl ether handling operations shall be provided with and required to wear and use a full-face, supplied air respirator, of the continuous flow or pressure-demand type, in accordance with 1910.134.

(vi) Drinking fountains are prohibited in the regulated area.

(5) "Maintenance and decontamination activities." In cleanup of leaks or spills, maintenance or repair operations on contaminated systems or equipment, or any operations involving work in an area where direct contact with methyl chloromethyl ether could result, each authorized employee entering that area shall:

(i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(2) "Emergencies." In an emergency, immediate measures including, but not limited to, the requirements of paragraphs (d)(2)(i), (ii), (iii), (iv), and (v) of this section shall be implemented.

(i) The potentially affected area shall be evacuated as soon as the emergency has been determined.

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with methyl chloromethyl ether, such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees wear protective clothing and equipment, clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(iii) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iv) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(1) and (2) (ii) through (vii).

(v) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iii) Decontamination procedures shall be established and implemented to remove methyl chloromethyl ether from the surfaces of materials, equipment and the decontamination facility.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA IMPERVIOUS SUIT
INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of methyl chloromethyl ether and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of methyl chloromethyl ether and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii) (B) of this section which are accessible to, or handled by, employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have methyl chloromethyl ether contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(5) "Training and indoctrination." (i) Each employee prior to being authorized to enter a regulated area, shall receive a training and indoctrination program including, but not necessarily limited to: (A) The nature of the carcinogenic hazards of methyl chloromethyl ether, including local and systemic toxicity;

(B) The specific nature of the operation involving methyl chloromethyl ether which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of methyl chloromethyl ether;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of methyl chloromethyl ether in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which methyl chloromethyl ether is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of methyl chloromethyl ether into any area where employees may be potentially exposed shall be reported in accordance with this subparagraph.

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances be taken, with specific completion dates, of the incident, and measures taken or to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0086)

[58 FR 35559, July 1, 1993]

1915.1007 3,3'-Dichlorobenzidine (and its salts).

(a) "Scope and application." (1) This section applies to any area in which 3,3'-Dichlorobenzidine (or its salts), Chemical Abstracts Service Registry Number 91941 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 1 percent by weight or volume of 3,3'-Dichlorobenzidine (or its salts).

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of 3,3'-Dichlorobenzidine (or its salts). The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving 3,3'-Dichlorobenzidine (or its salts) where containment prevents the release of 3,3'-Dichlorobenzidine (or its salts) into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of 3,3'-Dichlorobenzidine or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of 3,3'-Dichlorobenzidine (or its salts) from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of 3,3'-Dichlorobenzidine (or its salts) which may result in exposure to or contact with 3,3'-Dichlorobenzidine (or its salts).

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment, of 3,3'-Dichlorobenzidine (or its salts), which is impervious to the passage of 3,3'-Dichlorobenzidine (or its salts) and which would prevent the entry of 3,3'-Dichlorobenzidine (or its salts) into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving 3,3'-Dichlorobenzidine (or its salts) within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated" area means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving 3,3'-Dichlorobenzidine (or its salts) in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of 3,3'-Dichlorobenzidine (or its salts) into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to 3,3'-Dichlorobenzidine (or its salts).

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing 3,3'-Dichlorobenzidine (or its salts)." A regulated area shall be established by an employer where 3,3'-Dichlorobenzidine (or its salts) is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with 3,3'-Dichlorobenzidine (or its salts) within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where 3,3'-Dichlorobenzidine (or its salts) is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while 3,3'-Dichlorobenzidine (or its salts) is contained within:

(i) Access shall be restricted to authorized employees only;

(ii) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit and before engaging in other activities.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where 3,3'-Dichlorobenzidine (or its salts) is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iv) Employees engaged in 3,3'-Dichlorobenzidine (or its salts) handling operations shall be provided with and required to wear and use a half-face, filter-type respirator for dusts, mists, and fumes, in accordance with 1910.134. A respirator affording higher levels of protection may be substituted.

(vi) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities.

(vii) Employees shall be required to shower after the last exit of the day.

(viii) Drinking fountains are prohibited in the regulated area.

(5) "Maintenance and decontamination activities." In cleanup of leaks or spills, maintenance or repair operations on contaminated systems or equipment, or any operations involving work in an area where direct contact with 3,3'-Dichlorobenzidine (or its salts) could result, each authorized employee entering that area shall:

(i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(2) "Emergencies." In an emergency, immediate measures including, but not limited to, the requirements of paragraphs (d)(2)(i), (ii), (iii), (iv), and (v) of this section shall be implemented.

(i) The potentially affected area shall be evacuated as soon as the emergency has been determined.

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with 3,3'-Dichlorobenzidine (or its salts), such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2)(ii) through (vii).

(iii) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iv) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(v) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iii) Decontamination procedures shall be established and implemented to remove 3,3'-Dichlorobenzidine (or its salts) from the surfaces of materials, equipment and the decontamination facility.

(iv) Dry sweeping and dry mopping are prohibited.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of 3,3'-Dichlorobenzidine (or its salts) and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of 3,3'-Dichlorobenzidine (or its salts) and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by, employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have 3,3'-Dichlorobenzidine (or its salts) contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(4) Prohibited statements. No statement shall appear on or near any required sign, label, or instruction which contradicts or detracts from the effect of any required warning, information or instruction.

(A) The nature of the carcinogenic hazards of 3,3'-Dichlorobenzidine (or its salts), including local and systemic toxicity;

(B) The specific nature of the operation involving 3,3'-Dichlorobenzidine (or its salts) which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of 3,3'-Dichlorobenzidine (or its salts);

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of 3,3'-Dichlorobenzidine (or its salts) in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which 3,3'-Dichlorobenzidine (or its salts) is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of 3,3'-Dichlorobenzidine (or its salts) into any area where employees may be potentially exposed shall be reported in accordance with this subparagraph. (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the nearest OSHA Area Director.

(ii) A written report shall be filed with the nearest OSHA Area Director within 15 calendar days thereafter and shall include:

(A) A specification of the amount of material released, the amount of time involved, and an explanation of the procedure used in determining this figure;

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination, and (C) A report of any medical treatment of affected employees, and any medical surveillance program implemented; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(iii) In all physical examinations, the examining physician shall consider whether there exist conditions of increased risk, including reduced immunological competence, those undergoing treatment with steroids of cytotoxic agents, pregnancy and cigarette smoking.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0083)

[58 FR 35562, July 1, 1993]

1915.1008 bis-Chloromethyl ether.

(a) "Scope and application." (1) This section applies to any area in which bis-chloromethyl ether, Chemical Abstracts Service Registry Number 542881 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 0.1 percent by weight or volume of bis-chloromethyl ether.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of bis-chloromethyl ether. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system means" an operation involving bis-chloromethyl ether where containment prevents the release of bis-chloromethyl ether into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of bis-chloromethyl ether or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of bis-chloromethyl ether from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of bis-chloromethyl ether which may result in exposure to or contact with bis-chloromethyl ether.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment, of bis-chloromethyl ether, which is impervious to the passage of, bis-chloromethyl ether and which would prevent the entry of bis-chloromethyl ether into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving bis-chloromethyl ether within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving bis-chloromethyl ether in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of bis-chloromethyl ether into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to bis-chloromethyl ether.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing bis-chloromethyl ether." A regulated area shall be established by an employer where bis-chloromethyl ether is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with bis-chloromethyl ether within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where bis-chloromethyl ether is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while bis-chloromethyl ether is contained within. Access shall be restricted to authorized employees only.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where bis-chloromethyl ether is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this paragraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iv) Employees engaged in bis-chloromethyl ether handling operations shall be provided with and required to wear and use a full-face, supplied air respirator, of the continuous flow or pressure-demand type, in accordance with 1910.134.

(vi) Drinking fountains are prohibited in the regulated area.

(5) "Maintenance and decontamination activities." In cleanup of leaks or spills, maintenance or repair operations on contaminated systems or equipment, or any operations involving work in an area where direct contact with bis-chloromethyl ether could result, each authorized employee entering that area shall:

(i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(2) "Emergencies." In an emergency, immediate measures including, but not limited to, the requirements of paragraphs (d)(2)(i), (ii), (iii), (iv), and (v) of this section shall be implemented. (i) The potentially affected area shall be evacuated as soon as the emergency has been determined.

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with bis-chloromethyl ether such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(iii) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iv) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2) (ii) through (vii).

(v) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iii) Decontamination procedures shall be established and implemented to remove bis-chloromethyl ether from the surfaces of materials, equipment and the decontamination facility.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identifications." (i) Containers of bis-chloromethyl ether and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of bis-chloromethyl ether and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by, employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have bis-chloromethyl ether contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(3) "Lettering." Lettering on signs and instructions required by subparagraph (1) of this paragraph shall be a minimum letter height of 2 inches (5.08 cm). Labels on containers required under this section shall not be less than 1/2 the size of the largest lettering on the package, and not less than 8 point type in any instance: "Provided," That no such required lettering need be more than 1 inch (2.54 cm) in height.

(5) "Training and indoctrination." (i) Each employee prior to being authorized to enter a regulated area, shall receive a training and indoctrination program including, but not necessarily limited to: (A) The nature of the carcinogenic hazards of bis-chloromethyl ether, including local and systemic toxicity;

(B) The specific nature of the operation involving bis-chloromethyl ether which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of bis-chloromethyl ether;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(i) A brief description and inplant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of bis-chloromethyl ether in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which bis-chloromethyl ether is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of bis-chloromethyl ether into any area where employees may be potentially exposed shall be reported in accordance with this subparagraph. (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the nearest OSHA Area Director.

(ii) A written report shall be filed with the nearest OSHA Area Director within 15 calendar days thereafter and shall include:

(A) A specification of the amount of material released, the amount of time involved, and an explanation of the procedure used in determining this figure;

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0087)

[58 FR 35564, July 1, 1993]

1915.1009 beta-Naphthylamine.

(a) "Scope and application." (1) This section applies to any area in which beta-Naphthylamine, Chemical Abstracts Service Registry Number 91598 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to transshipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 0.1 percent by weight or volume of beta-Naphthylamine.

(3) This section will not apply to operations involving the destructive distillation of carbonaceous materials, such as occurs in coke ovens.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of beta-Naphthylamine. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving beta-Naphthylamine where containment prevents the release of beta-Naphthylamine into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of beta-Naphthylamine or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of beta-Naphthylamine from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of beta-Naphthylamine which may result in exposure to or contact with beta-Naphthylamine.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of beta-Naphthylamine, which is impervious to the passage of beta-Naphthylamine, and which would prevent the entry of beta-Naphthylamine into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving beta-Naphthylamine within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving beta-Naphthylamine in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of beta-Naphthylamine into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to beta-Naphthylamine.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing beta-Naphthylamine." A regulated area shall be established by an employer where beta-Naphthylamine is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved: (1) "Isolated systems." Employees working with beta-Naphthylamine within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where beta-Naphthylamine is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while beta-Naphthylamine is contained within; (i) Access shall be restricted to authorized employees only;

(ii) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit and before engaging in other activities.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where beta-Naphthylamine is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this paragraph shall apply.

(i) Access shall be restricted to authorized employees only.

(iv) Employees engaged in beta-Naphthylamine handling operations shall be provided with and required to wear and use a half-face, filter-type respirator for dusts, mists, and fumes, in accordance with 1910.134. A respirator affording higher levels of protection may be substituted.

(vi) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities.

(vii) Employees shall be required to shower after the last exit of the day.

(viii) Drinking fountains are prohibited in the regulated area.

(i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with beta-Naphthylamine, such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2)(ii) through (vii).

(iii) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iv) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(v) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iii) Decontamination procedures shall be established and implemented to remove beta-Naphthylamine from the surfaces of materials, equipment and the decontamination facility.

(iv) Dry sweeping and dry mopping are prohibited.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of beta-Naphthylamine and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of beta-Naphthylamine and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have beta-Naphthylamine contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(3) "Lettering." Lettering on signs and instructions required by paragraph (e)(1) shall be a minimum letter height of 2 inches (5.08 cm). Labels on containers required under this section shall not be less than 1/2 the size of the largest lettering on the package, and not less than 8 point type in any instance: "Provided," That no such required lettering need be more than 1 inch (2.54 cm) in height.

(5) "Training and indoctrination." (i) Each employee prior to being authorized to enter a regulated area, shall receive a training and indoctrination program including, but not necessarily limited to: (A) The nature of the carcinogenic hazards of beta-Naphthylamine, including local and systemic toxicity;

(B) The specific nature of the operation involving beta-Naphthylamine which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of beta-Naphthylamine;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of beta-Naphthylamine in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which beta-Naphthylamine is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of beta-Naphthylamine into any area where employees may be potentially exposed shall be reported in accordance with this subparagraph. (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the nearest OSHA Area Director.

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination;

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(iii) In all physical examinations the examining physician shall consider whether there exist conditions of increased risk, including reduced immunological competence, those undergoing treatment with steroids or cytotoxic agents, pregnancy and cigarette smoking.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0089)

[58 FR 35567, July 1, 1993]

1915.1010 Benzidine.

(a) "Scope and application." (1) This section applies to any area in which Benzidine, Chemical Abstracts Service Registry Number 92875 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to transshipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 0.1 percent by weight or volume in Benzidine.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono dispense aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of Benzidine. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving Benzidine where containment prevents the release of Benzidine into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of Benzidine or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of Benzidine from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of Benzidine which may result in exposure to or contact with Benzidine.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of Benzidine, which is impervious to the passage of Benzidine, and which would prevent the entry of Benzidine into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving Benzidine within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving Benzidine in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of Benzidine into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to Benzidine.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing Benzidine." A regulated area shall be established by an employer where Benzidine is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with Benzidine within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where Benzidine is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while Benzidine is contained within:

(i) Access shall be restricted to authorized employees only;

(ii) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit and before engaging in other activities.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where Benzidine is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply. (i) Access shall be restricted to authorized employees only;

(iv) Employees engaged in Benzidine handling operations shall be provided with and required to wear and use a half-face, filter-type respirator for dusts, mists, and fumes, in accordance with 1910.134. A respirator affording higher levels of protection may be substituted.

(vi) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities.

(vii) Employees shall be required to shower after the last exit of the day.

(viii) Drinking fountains are prohibited in the regulated area.

(5) "Maintenance and decontamination activities." In cleanup of leaks or spills, maintenance or repair operations on contaminated systems or equipment, where direct contact with Benzidine could result, each authorized employee entering that area shall: (i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with Benzidine such employee shall be required to shower as soon as possible unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2) (ii) through (vii).

(iii) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iv) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(v) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iii) Decontamination procedures shall be established and implemented to remove Benzidine from the surfaces of materials, equipment and the decontamination facility.

(iv) Dry sweeping and dry mopping are prohibited.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of Benzidine and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of Benzidine and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have Benzidine contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(B) The specific nature of the operation involving Benzidine which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of Benzidine;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(ii) The name(s) and other identifying information as to the presence of Benzidine in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which Benzidine is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of Benzidine into any area where employees may be potentially exposed shall be reported in accordance with this paragraph. (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the nearest OSHA Area Director.

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0082)

[58 FR 35570, July 1, 1993]

1915.1011 4-Aminodiphenyl.

(a) "Scope and application." (1) This section applies to any area in which 4-Aminodiphenyl, Chemical Abstracts Service Registry Number 92671 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 0.1 percent by weight or volume of 4-Aminodiphenyl.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change" room means a room where employees put on clean clothing and/or protective equipment in an environment free of 4-Aminodiphenyl. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving 4-Aminodiphenyl where containment prevents the release of 4-Aminodiphenyl into regulated areas, nonregulated area, or the external environment.

(5) "Decontamination" means the inactivation of 4-Aminodiphenyl or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of 4-Aminodiphenyl from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of 4-Aminodiphenyl which may result in exposure to or contact with 4-Aminodiphenyl.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of 4-Aminodiphenyl, which is impervious to the passage of 4-Aminodiphenyl, and which would prevent the entry of 4-Aminodiphenyl into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving 4-Aminodiphenyl within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving 4-Aminodiphenyl in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of 4-Aminodiphenyl into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to 4-Aminodiphenyl.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing 4-Aminodiphenyl." A regulated area shall be established by an employer where 4-Aminodiphenyl is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with 4-Aminodiphenyl within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where 4-Aminodiphenyl is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while 4-Aminodiphenyl is contained within:

(i) Access shall be restricted to authorized employees only;

(ii) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit and before engaging in other activities.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where 4-Aminodiphenyl is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iv) Employees engaged in 4-Aminodiphenyl handling operations shall be provided with and required to wear and use a half-face, filter-type respirator for dusts, mists, and fumes, in accordance with 1910.134. A respirator affording higher levels of protection may be substituted.

(vi) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities.

(vii) Employees shall be required to shower after the last exit of the day.

(viii) Drinking fountains are prohibited in the regulated area.

(i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with 4-Aminodiphenyl such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2)(ii) through (vii).

(iii) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iv) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(v) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iii) Decontamination procedures shall be established and implemented to remove 4-Aminodiphenyl from the surfaces of materials, equipment and the decontamination facility.

(iv) Dry sweeping and dry mopping are prohibited.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING
GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of 4-Aminodiphenyl and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of 4-Aminodiphenyl and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by, employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have 4-Aminodiphenyl contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(3) "Lettering." Lettering on signs and instructions required by subparagraph (1) shall be a minimum letter height of 2 inches (5.08 cm). Labels on containers required under this section shall not be less than 1/2 the size of the largest lettering on the package, and not less than 8 point type in any instance: "Provided," That no such required lettering need be more than 1 inch (2.54 cm) in height.

(5) "Training and indoctrination." (i) Each employee prior to being authorized to enter a regulated area, shall receive including, but not necessarily limited to: A training and indoctrination program. (A) The nature of the carcinogenic hazards of 4-Aminodiphenyl, including local and systemic toxicity;

(B) The specific nature of the operation involving 4-Aminodiphenyl which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of 4-Aminodiphenyl;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in this application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(ii) The name(s) and other identifying information as to the presence of 4-Aminodiphenyl in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which 4-Aminodiphenyl is present in each regulated area; e.g. whether it is manufactured, processed, used repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of 4-Aminodiphenyl into any area where employees may be potentially exposed shall be reported in accordance with this paragraph. (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the nearest OSHA Area Director.

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0090)

[58 FR 35572, July 1, 1993]

1915.1012 Ethyleneimine.

(a) "Scope and application." (1) This section applies to any area in which Ethyleneimine, Chemical Abstracts Service Registry Number 151564 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 1.0 percent by weight or volume of Ethyleneimine.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of Ethyleneimine. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving Ethyleneimine where containment prevents the release of Ethyleneimine into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of Ethyleneimine or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of Ethyleneimine from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of Ethyleneimine which may result in exposure to or contact with Ethyleneimine.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of Ethyleneimine, which is impervious to the passage of Ethyleneimine, and which would prevent the entry of Ethyleneimine into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving Ethyleneimine within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving Ethyleneimine in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of Ethyleneimine into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to Ethyleneimine.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing Ethyleneimine." A regulated area shall be established by an employer where Ethyleneimine is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with Ethyleneimine within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where Ethyleneimine is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while Ethyleneimine is contained within: Access shall be restricted to authorized employees only.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where Ethyleneimine is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iv) Employees engaged in Ethyleneimine handling operations shall be provided with and required to wear and use a full-face, supplied air respirator, of the continuous flow or pressure-demand type, in accordance with 1910.134.

(vi) Drinking fountains are prohibited in the regulated area.

(i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with Ethyleneimine, such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(vi) Emergency deluge showers and eyewash fountains supplied with running potable water shall be located near, within sight of, and on the same level with locations where a direct exposure of Ethyleneimine would be most likely as a result of equipment failure, or improper work practice.

(ii) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(iii) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iv) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2)(ii) through (vii).

(v) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iii) Decontamination procedures shall be established and implemented to remove Ethyleneimine from the surfaces of materials, equipment and the decontamination facility.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of Ethyleneimine and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of Ethyleneimine and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii) (B) of this section which are accessible to, or handled by employees other than authorized employees or employees trained in accordance with paragraph (e)5 of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have Ethyleneimine contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(5) "Training and indoctrination." (i) Each employee prior to being authorized to enter a regulated area, shall receive a training and indoctrination program including, but not necessarily limited to: (A) The nature of the carcinogenic hazards of Ethyleneimine, including local and systemic toxicity;

(B) The specific nature of the operation involving Ethyleneimine which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of Ethyleneimine;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(ii) The name(s) and other identifying information as to the presence of Ethyleneimine in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which Ethyleneimine is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of Ethyleneimine into any area where employees may be potentially exposed shall be reported in accordance with this paragraph. (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the nearest OSHA Area Director.

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0080)

[58 FR 35575, July 1, 1993]

1915.1013 beta-Propiolactone.

(a) "Scope and application." (1) This section applies to any area in which beta-Propiolactone, Chemical Abstracts Service Registry Number 57578 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 1.0 percent by weight or volume of beta-Propiolactone.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of beta-Propiolactone. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving beta-Propiolactone where containment prevents the release of beta-Propiolactone into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of beta-Propiolactone or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of beta-Propiolactone from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of beta-Propiolactone which may result in exposure to or contact with beta-Propiolactone.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of beta-Propiolactone, which is impervious to the passage of beta-Propiolactone, and which would prevent the entry of beta-Propiolactone into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving beta-Propiolactone within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving beta-Propiolactone in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of beta-Propiolactone into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to beta-Propiolactone.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing beta-Propiolactone." A regulated area shall be established by an employer where beta-Propiolactone is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with beta-Propiolactone within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where beta-Propiolactone is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while beta-Propiolactone is contained within. Access shall be restricted to authorized employees only.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where beta-Propiolactone is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iv) Employees engaged in beta-Propiolactone handling operations shall be provided with and required to wear and use a full-face, supplied air respirator, of the continuous flow or pressure-demand type, in accordance with 1910.134.

(vi) Drinking fountains are prohibited in the regulated area.

(5) "Maintenance and decontamination activities." In cleanup of leaks or spills, maintenance or repair operations on contaminated systems or equipment, where direct contact with beta-Propiolactone could result, each authorized employee entering that area shall: (i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with beta-Propiolactone, such employee shall be required to shower soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(vi) Emergency deluge showers and eyewash fountains supplied with running potable water shall be located near, within sight of, and on the same level with locations where a direct exposure to beta-Propiolactone would be most likely as a result of equipment failure, or improper work practice.

(ii) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(iii) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iv) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2)(ii) through (vii).

(v) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iii) Decontamination procedures shall be established and implemented to remove beta-Propiolactone from the surfaces of materials, equipment and the decontamination facility.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of beta-Propiolactone and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of beta-Propiolactone and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by, employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have beta-Propiolactone contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(3) "Lettering." Lettering on signs and instructions required by paragraph (e)(1) shall be a minimum letter height of 2 inches. Labels on containers required under this section shall not be less than 1/2 the size of the largest lettering on the package, and not less than 8 point type in any instance: "Provided," That no such required lettering need be more than 1 inch in height.

(A) The nature of the carcinogenic hazards of beta-Propiolactone, including local and systemic toxicity;

(B) The specific nature of the operation involving beta-Propiolactone which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of beta-Propiolactone;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of beta-Propiolactone in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which beta-Propiolactone is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of beta-Propiolactone into any area where employees may be potentially exposed shall be reported in accordance with this subparagraph. (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the nearest OSHA Area Director.

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0079)

[58 FR 35577, July 1, 1993]

1915.1014 2-Acetylaminofluorene.

(a) "Scope and application." (1) This section applies to any area in which 2-Acetylaminofluorene, Chemical Abstracts Service Registry Number 53963 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 1.0 percent by weight or volume of 2-Acetylaminofluorene.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of 2-Acetylaminofluorene. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving 2-Acetylaminofluorene where containment prevents the release of 2-Acetylaminofluorene into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of 2-Acetylaminofluorene or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of 2-Acetylaminofluorene from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of 2-Acetylaminofluorene which may result in exposure to or contact with 2-Acetylaminofluorene.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of 2-Acetylaminofluorene, which is impervious to the passage of 2-Acetylaminofluorene, and which would prevent the entry of 2-Acetylaminofluorene into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving 2-Acetylaminofluorene within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving 2-Acetylaminofluorene in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of 2-Acetylaminofluorene into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to 2-Acetylaminofluorene.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing 2-Acetylaminofluorene." A regulated area shall be established by an employer where 2-Acetylaminofluorene is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with 2-Acetylaminofluorene within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where 2-Acetylaminofluorene is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while 2-Acetylaminofluorene is contained within:

(i) Access shall be restricted to authorized employees only;

(ii) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit and before engaging in other activities.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where 2-Acetylaminofluorene is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iv) Employees engaged in 2-Acetylaminofluorene handling operations shall be provided with and required to wear and use a half-face, filter-type respirator for dusts, mists, and fumes, in accordance with 1910.134. A respirator affording higher levels of protection may be substituted.

(vi) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities.

(vii) Employees shall be required to shower after the last exit of the day.

(viii) Drinking fountains are prohibited in the regulated area.

(i) Be provided with and required to wear clean, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(2) "Emergencies." In an emergency, immediate measures including, but not limited to, the requirements of paragraphs (d)(2)(i), (ii), (iii), (iv), and (v) of this section shall be implemented.

(i) The potentially affected area shall be evacuated as soon as the emergency has been determined.

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with 2-Acetylaminofluorene, such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2)(ii) through (vii).

(iii) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iv) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(v) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iii) Decontamination procedures shall be established and implemented to remove 2-Acetylaminofluorene from the surfaces of materials, equipment and the decontamination facility.

(iv) Dry sweeping and dry mopping are prohibited.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of 2-Acetylaminofluorene and containers required under paragraphs (c)(4)(v) and (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification, limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of 2-Acetylaminofluorene and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by, employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have 2-Acetylaminofluorene contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(3) "Lettering." Lettering on signs and instructions required by subparagraph (1) shall be a minimum letter height of 2 inches (5.08 cm). Labels on containers required under this section shall not be less than 1/2 the size of the largest lettering on the package, and not less than 8 point type in any instance; "Provided," That no such required lettering need be more than 1 inch (2.54 cm) in height.

(5) "Training and indoctrination." (i) Each employee prior to being authorized to enter a regulated area, shall receive a training and indoctrination program including, but not necessarily limited to: (A) The nature of the carcinogenic hazards of 2-Acetylaminofluorene, including local and systemic toxicity;

(B) The specific nature of the operation involving 2-Acetylaminofluorene which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of 2-Acetylaminofluorene;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees, shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of 2-Acetylaminofluorene in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which 2-Acetylaminofluorene is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of 2-Acetylaminofluorene into any area where employees may be potentially exposed shall be reported in accordance with this subparagraph.

(ii) A written report shall be filed with the nearest OSHA Area Director within 15 calendar days thereafter and shall include:

(A) A specification of the amount of material released, the amount of time involved, and an explanation of the procedure used in determining this figure;

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0088)

[58 FR 35580, July 1, 1993]

1915.1015 4-Dimethylaminoazobenzene.

(a) "Scope and application." (1) This section applies to any area in which 4-Dimethylaminoazobenzene, Chemical Abstracts Service Registry Number 60117 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 1.0 percent by weight or volume of 4-Dimethylaminoazobenzene.

(b) "Definitions." For the purposes of this section: (1) "Absolute filter" is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of 4-Dimethylaminoazobenzene. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving 4-Dimethylaminoazobenzene where containment prevents the release of 4-Dimethylaminoazobenzene into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination" means the inactivation of 4-Dimethylaminoazobenzene or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of 4-Dimethylaminoazobenzene from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of 4-Dimethylaminoazobenzene which may result in exposure to or contact with 4-Dimethylaminoazobenzene.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of 4-Dimethylaminoazobenzene, which is impervious to the passage of 4-Dimethylaminoazobenzene which would prevent the entry of 4-Dimethylaminoazobenzene into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving 4-Dimethylaminoazobenzene within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving 4-Dimethylaminoazobenzene in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of 4-Dimethylaminoazobenzene into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to 4-Dimethylaminoazobenzene.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing 4-Dimethylaminoazobenzene." A regulated area shall be established by an employer where 4-Dimethylaminoazobenzene is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with 4-Dimethylaminoazobenzene within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where 4-Dimethylaminoazobenzene is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while 4-Dimethylaminoazobenzene is contained within:

(i) Access shall be restricted to authorized employees only;

(ii) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit and before engaging in other activities.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving "laboratory type hoods," or in locations where 4-Dimethylaminoazobenzene is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iii) Employees shall be provided with, and required to wear, clean, full body protective clothing (smocks, coveralls, or long-sleeved shirt and pants), shoe covers, and gloves prior to entering the regulated area.

(iv) Employees engaged in 4-Dimethylaminoazobenzene handling operations shall be provided with and required to wear and use a half-face, filter-type respirator for dusts, mists, and fumes, in accordance with 1910.134. A respirator affording higher levels of protection may be substituted.

(vi) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities.

(vii) Employees shall be required to shower after the last exist of the day.

(viii) Drinking fountains are prohibited in the regulated area.

(5) "Maintenance and decontamination activities." In cleanup of leaks or spills, maintenance or repair operations on contaminated systems or equipment, where direct contact with 4-Dimethylaminoazobenzene could result, each authorized employee entering that area shall: (i) Be provided with and required to wear clear, impervious garments, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with 4-Dimethylaminoazobenzene, such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d) (1) and (2) (ii) through (vii).

(iii) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iv) Where employees wear protective clothing and equipment clean change room shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(v) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iii) Decontamination procedures shall be established and implemented to remove 4-Dimethylaminoazobenzene from the surfaces of materials, equipment and the decontamination facility.

(iv) Dry sweeping and dry mopping are prohibited.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of 4-Dimethylaminoazobenzene and containers required under paragraph (c)(4)(v) and (c)(6)(vii) (B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of 4-Dimethylaminoazobenzene and containers required under paragraphs (c)(4)(v), (c)(6)(vii) (B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have 4-Dimethylaminoazobenzene contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(A) The nature of the carcinogenic hazards of 4-Dimethylaminoazobenzene, including local and sytemic toxicity;

(B) The specific nature of the operation involving 4-Dimethylaminoazobenzene which could result in exposure;

(C) The purpose for the application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose for and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of 4-Dimethylaminoazobenzene;

(H) The purpose for and application of specific first aid procedures and practices;

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of 4-Dimethylaminoazobenzene in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which 4-Dimethylaminoazobenzene is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of 4-Dimethylaminoazobenzene into any area where employees may be potentially exposed shall be reported in accordance with this paragraph.

(ii) A written report shall be filed with the nearest OSHA Area Director within 15 calendar days thereafter and shall include:

(A) A specification of the amount of material released, the amount of time involved, and an explanation of the procedure used in determining this figure;

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(iii) In all physical examination, the examining physician shall consider whether there exist conditions of increased risk, including reduced immunological competence, those undergoing treatment with steroids or cytotoxic agents, pregnancy and cigarette smoking.

(2) "Records." (i) Employers of employees examined pursuant to this paragraph shall cause to be maintained complete and accurate records of all such medical examination. Records shall be maintained for the duration of the employee's employment. Upon termination of the employee's employment, including retirement or death, or in the event that the employer ceases business without a successor, records, or notarized true copies thereof, shall be forwarded by registered mail to the Director.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0044)

[58 FR 35582, July 1, 1993]

1915.1016 N-Nitrosodimethylamine.

(a) "Scope and application." (1) This section applies to any area in which N-Nitrosodimethylamine, Chemical Abstracts Service Registry Number 62759 is manufactured, processed, repackaged, released, handled, or stored, but shall not apply to trans-shipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid mixtures containing less than 1.0 percent by weight or volume of N-Nitrosodimethylamine.

(b) "Definitions." For the purposes of this section: (1) Absolute filter is one capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 um particles.

(2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.

(3) "Clean change room" means a room where employees put on clean clothing and/or protective equipment in an environment free of N-Nitrosodimethylamine. The clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this section.

(4) "Closed system" means an operation involving N-Nitrosodimethylamine where containment prevents the release of N-Nitrosodimethylamine into regulated areas, nonregulated areas, or the external environment.

(5) "Decontamination means" the inactivation of N-Nitrosodimethylamine or its safe disposal.

(6) "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health and Human Services to act for the Director.

(7) "Disposal" means the safe removal of N-Nitrosodimethylamine from the work environment.

(8) "Emergency" means an unforeseen circumstance or set of circumstances resulting in the release of N-Nitrosodimethylamine which may result in exposure to or contact with N-Nitrosodimethylamine.

(9) "External environment" means any environment external to regulated and nonregulated areas.

(10) "Isolated system" means a fully enclosed structure other than the vessel of containment of N-Nitrosodimethylamine, which is impervious to the passage of N-Nitrosodimethylamine, and which would prevent the entry of N-Nitrosodimethylamine into regulated areas, nonregulated areas, or the external environment, should leakage or spillage from the vessel of containment occur.

(11) "Laboratory type hood" is a device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed, and maintained in such a way that an operation involving N-Nitrosodimethylamine within the hood does not require the insertion of any portion of any employee's body other than his hands and arms.

(12) "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled.

(13) "Open-vessel system" means an operation involving N-Nitrosodimethylamine in an open vessel, which is not in an isolated system, a laboratory type hood, nor in any other system affording equivalent protection against the entry of N-Nitrosodimethylamine into regulated areas, nonregulated areas, or the external environment.

(14) "Protective clothing" means clothing designed to protect an employee against contact with or exposure to N-Nitrosodimethylamine.

(15) "Regulated area" means an area where entry and exit is restricted and controlled.

(c) "Requirements for areas containing N-Nitrosodimethylamine." A regulated area shall be established by an employer where N-Nitrosodimethylamine is manufactured, processed, used, repackaged, released, handled or stored. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:

(1) "Isolated systems." Employees working with N-Nitrosodimethylamine within an isolated system, such as a "glove box" shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.

(2) "Closed system operation." Within regulated areas where N-Nitrosodimethylamine is stored in sealed containers, or contained in a closed system, including piping systems, with any sample ports or openings closed while N-Nitrosodimethylamine is contained within:

(i) Access shall be restricted to authorized employees only;

(ii) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit and before engaging in other activities.

(3) "Open vessel system operations." Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.

(4) "Transfer from a closed system, charging or discharging point operations, or otherwise opening a closed system." In operations involving " laboratory type hoods," or in locations where N-Nitrosodimethylamine is contained in an otherwise "closed system," but is transferred, charged, or discharged into other normally closed containers, the provisions of this subparagraph shall apply.

(i) Access shall be restricted to authorized employees only;

(iv) Employees engaged in N-Nitrosodimethylamine handling operations shall be provided with and required to wear and use a half-face, filter-type respirator for dusts, mists, and fumes, in accordance with 1910.134. A respirator affording higher levels of protection may be substituted.

(vi) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities.

(vii) Employees shall be required to shower after the last exit of the day.

(viii) Drinking fountains are prohibited in the regulated area.

(i) Be provided with and required to wear clean, impervious garment, including gloves, boots and continuous-air supplied hood in accordance with 1910.134.

(ii) Be decontaminated before removing the protective garments and hood;

(iii) Be required to shower upon removing the protective garments and hood.

(d) "General regulated area requirements."

(1) [Reserved]

(2) "Emergencies." In an emergency, immediate measures including, but not limited to, the requirements of paragraphs (d)(2)(i), (ii), (iii), (iv), and (v) of this section shall be implemented.

(i) The potentially affected area shall be evacuated as soon as the emergency has been determined.

(ii) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.

(iv) Where an employee has a known contact with N-Nitrosodimethylamine, such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries.

(v) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.

(ii) Where employees are required by this section to wash, washing facilities shall be provided in accordance with 1910.141(d)(1) and (2)(ii) through (vii).

(iii) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d)(3).

(iv) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 1910.141(e), for the number of such employees required to change clothes.

(v) Where toilets are in regulated areas, such toilets shall be in a separate room.

(iii) Decontamination procedures shall be established and implemented to remove N-Nitrosodimethylamine from the surfaces of materials, equipment and the decontamination facility.

(iv) Dry sweeping and dry mopping are prohibited.

(e) "Signs, information and training" - (1) "Signs." (i) Entrances to regulated areas shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5) of this section shall be posted with signs bearing the legend:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(2) "Container contents identification." (i) Containers of N-Nitrosodimethylamine and containers required under paragraphs (c)(4)(v) and (c)(6)(vii) (B), and (c)(6)(viii)(B) of this section which are accessible only to, and handled only by, authorized employees, or by other employees trained in accordance with paragraph (e)(5) of this section, may have contents identification limited to a generic or proprietary name, or other proprietary identification, of the carcinogen and percent.

(ii) Containers of N-Nitrosodimethylamine and containers required under paragraphs (c)(4)(v), (c)(6)(vii)(B), and (c)(6)(viii)(B) of this section which are accessible to, or handled by employees other than authorized employees or employees trained in accordance with paragraph (e)(5) of this section shall have contents identification which includes the full chemical name and Chemical Abstracts Service Registry number as listed in paragraph (a)(1) of this section.

(iii) Containers shall have the warning words "CANCER-SUSPECT AGENT" displayed immediately under or adjacent to the contents identification.

(iv) Containers which have N-Nitrosodimethylamine contents with corrosive or irritating properties shall have label statements warning of such hazards, noting, if appropriate, particularly sensitive or affected portions of the body.

(A) The nature of the carcinogenic hazards of N-Nitrosodimethylamine, including local and systemic toxicity;

(B) The specific nature of the operation involving N-Nitrosodimethylamine which could result in exposure;

(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;

(D) The purpose of and application of decontamination practices and purposes;

(E) The purpose for and significance of emergency practices and procedures;

(F) The employee's specific role in emergency procedures;

(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of N-Nitrosodimethylamine;

(H) The purpose for and application of specific first aid procedures and practices.

(I) A review of this section at the employee's first training and indoctrination program and annually thereafter.

(ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in their application.

(iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director.

(i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area;

(ii) The name(s) and other identifying information as to the presence of N-Nitrosodimethylamine in each regulated area;

(iii) The number of employees in each regulated area, during normal operations including maintenance activities; and

(iv) The manner in which N-Nitrosodimethylamine is present in each regulated area; e.g. whether it is manufactured, processed, used, repackaged, released, stored, or otherwise handled.

(2) "Incidents." Incidents which result in the release of N-Nitrosodimethylamine into any area where employees may be potentially exposed shall be reported in accordance with this paragraph.

(ii) A written report shall be filed with the nearest OSHA Area Director within 15 calendar days thereafter and shall include:

(A) A specification of the amount of material released, the amount of time involved, and an explanation of the procedure used in determining this figure;

(B) A description of the area involved, and the extent of known and possible employee exposure and area contamination; and

(D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases.

(ii) Authorized employees shall be provided periodic physical examinations, not less often than annually, following the preassignment examination.

(2) "Records." (i) Employers of employees examined pursuant to this paragraph shall cause to be maintained complete and accurate records of all such medical examinations. Records shall be maintained for the duration of the employee's employment. Upon termination of an employee's employment, including retirement or death, or in the event that the employer ceases business without a successor, records, or notarized true copies thereof, shall be forwarded by registered mail to the Director.

(ii) Records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i). These records shall also be provided upon request to the Director.

(iii) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.

(Approved by the Office of Management and Budget under control number 1218-0081)

[58 FR 35585, July 1, 1993]

1915.1017 Vinyl chloride.

(a) "Scope and application." (1) This section includes requirements for the control of employee exposure to vinyl chloride (chloroethene), Chemical Abstracts Service Registry No. 75014.

(2) This section applies to the manufacture, reaction, packaging, repackaging, storage, handling or use of vinyl chloride or polyvinyl chloride, but does not apply to the handling or use of fabricated products made of polyvinyl chloride.

(3) This section applies to the transportation of vinyl chloride or polyvinyl chloride except to the extent that the Department of Transportation may regulate the hazards covered by this section.

(b) "Definitions." (1) "Action level" means a concentration of vinyl chloride of 0.5 ppm averaged over an 8-hour work day.

(2) "Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or his designee.

(3) "Authorized person" means any person specifically authorized by the employer whose duties require him to enter a regulated area or any person entering such an area as a designated representative of employees for the purpose of exercising an opportunity to observe monitoring and measuring procedures.

(4) "Director" means the Director, National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services or his designee.

(5) "Emergency" means any occurrence such as, but not limited to, equipment failure, or operation of a relief device which is likely to, or does, result in massive release of vinyl chloride.

(6) "Fabricated product" means a product made wholly or partly from polyvinyl chloride, and which does not require further processing at temperatures, and for times, sufficient to cause mass melting of the polyvinyl chloride resulting in the release of vinyl chloride.

(7) "Hazardous operation" means any operation, procedure, or activity where a release of either vinyl chloride liquid or gas might be expected as a consequence of the operation or because of an accident in the operation, which would result in an employee exposure in excess of the permissible exposure limit.

(8) "OSHA Area Director" means the Director for the Occupational Safety and Health Administration Area Office having jurisdiction over the geographic area in which the employer's establishment is located.

(9) "Polyvinyl chloride" means polyvinyl chloride homopolymer or copolymer before such is converted to a fabricated product.

(10) "Vinyl chloride" means vinyl chloride monomer.

(c) "Permissible exposure limit." (1) No employee may be exposed to vinyl chloride at concentrations greater than 1 ppm averaged over any 8-hour period, and

(2) No employee may be exposed to vinyl chloride at concentrations greater than 5 ppm averaged over any period not exceeding 15 minutes.

(3) No employee may be exposed to vinyl chloride by direct contact with liquid vinyl chloride.

(d) "Monitoring." (1) A program of initial monitoring and measurement shall be undertaken in each establishment to determine if there is any employee exposed, without regard to the use of respirators, in excess of the action level.

(2) Where a determination conducted under paragraph (d)(1) of this section shows any employee exposures, without regard to the use of respirators, in excess of the action level, a program for determining exposures for each such employee shall be established. Such a program:

(i) Shall be repeated at least monthly where any employee is exposed, without regard to the use of respirators, in excess of the permissible exposure limit.

(ii) Shall be repeated not less than quarterly where any employee is exposed, without regard to the use of respirators, in excess of the action level.

(iii) May be discontinued for any employee only when at least two consecutive monitoring determinations, made not less than 5 working days apart, show exposures for that employee at or below the action level.

(3) Whenever there has been a production, process or control change which may result in an increase in the release of vinyl chloride, or the employer has any other reason to suspect that any employee may be exposed in excess of the action level, a determination of employee exposure under paragraph (d)(1) of this section shall be performed.

(4) The method of monitoring and measurement shall have an accuracy (with a confidence level of 95 percent) of not less than plus or minus 50 percent from 0.25 through 0.5 ppm, plus or minus 35 percent from over 0.5 ppm through 1.0 ppm, and plus or minus 25 percent over 1.0 ppm. (Methods meeting these accuracy requirements are available in the "NIOSH Manual of Analytical Methods").

(5) Employees or their designated representatives shall be afforded reasonable opportunity to observe the monitoring and measuring required by this paragraph.

(e) "Regulated area." (1) A regulated area shall be established where:

(i) Vinyl chloride or polyvinyl chloride is manufactured, reacted, repackaged, stored, handled or used; and

(ii) Vinyl chloride concentrations are in excess of the permissible exposure limit.

(2) Access to regulated areas shall be limited to authorized persons.

(f) "Methods of compliance." Employee exposures to vinyl chloride shall be controlled to at or below the permissible exposure limit provided in paragraph (c) of this section by engineering, work practice, and personal protective controls as follows:

(1) Feasible engineering and work practice controls shall immediately be used to reduce exposures to at or below the permissible exposure limit.

(2) Wherever feasible engineering and work practice controls which can be instituted immediately are not sufficient to reduce exposures to at or below the permissible exposure limit, they shall nonetheless be used to reduce exposures to the lowest practicable level, and shall be supplemented by respiratory protection in accordance with paragraph (g) of this section. A program shall be established and implemented to reduce exposures to at or below the permissible exposure limit, or to the greatest extent feasible, solely by means of engineering and work practice controls, as soon as feasible.

(3) Written plans for such a program shall be developed and furnished upon request for examination and copying to authorized representatives of the Assistant Secretary and the Director. Such plans shall be updated at least every six months.

(g) "Respiratory protection." Where respiratory protection is required under this section:

(1) The employer shall provide a respirator which meets the requirements of this paragraph and shall assure that the employee uses such respirator, except that until April 1, 1976, wearing of respirators shall be at the discretion of each employee for exposures not in excess of 25 ppm, measured over any 15-minute period. Until April 1, 1976, each employee who chooses not to wear an appropriate respirator shall be informed at least quarterly of the hazards of vinyl chloride and the purpose, proper use, and limitations of respiratory devices.

(2) Respirators shall be selected from among those jointly approved by the Mining Enforcement and Safety Administration, Department of the Interior, and the National Institute for Occupational Safety and Health under the provisions of 30 CFR part 11.

(3) A respiratory protection program meeting the requirements of 1910.134 shall be established and maintained.

(4) Selection of respirators for vinyl chloride shall be as follows:

Atmospheric concentration of vinyl chloride	Required apparatus
(i) Unknown, or above 3,600 p/m	Open-circuit, self-contained breathing apparatus, pressure demand type, with full facepiece
(ii) Not over 3,600 p/m	(A) Combination type C supplied air respirator, pressure demand type, with full or half facepiece, and auxiliary self-contained air supply; or
(iii) Not over 1,000 p/m	(B) Combination type, supplied air respirator continuous flow type, with full or half facepiece, and auxiliary self-contained air supply Type C, supplied air respirator, continuous flow type, with full or half facepiece, helmet or hood
(iv) Not over 100 p/m	(A) Combination type C supplied air respirator demand type, with full facepiece, and auxiliary self-contained air supply; or (B) Open-circuit self-contained breathing apparatus with full facepiece, in demand mode; or (C) Type C supplied air respirator, demand type, with full facepiece
(v) Not over 25 p/m	(A) A powered air-purifying respirator with hood, helmet, full or half facepiece, and a canister which provides a service life of at least 4 hours for concentrations of vinyl chloride up to 25 p/m, or (B) Gas mask, front-or back-mounted canister which provides a service life of at least 4 hours for concentrations of vinyl chloride up to 25 p/m
(vi) Not over 10 p/m	(A) Combination type C supplied-air respirator, demand type, with half facepiece, and auxiliary self-contained air supply; or (B) Type C supplied-air respirator, demand type, with half facepiece; or (C) Any chemical cartridge respirator with an organic vapor cartridge which provides a service life of at least 1 hour for concentrations of vinyl chloride up to 10 p/m.

(5)(i) Entry into unknown concentrations or concentrations greater than 36,000 ppm (lower explosive limit) may be made only for purposes of life rescue; and

(ii) Entry into concentrations of less than 36,000 ppm, but greater than 3,600 ppm may be made only for purposes of life rescue, firefighting, or securing equipment so as to prevent a greater hazard from release of vinyl chloride.

(6) Where air-purifying respirators are used:

(i) Air-purifying canisters or cartridges shall be replaced prior to the expiration of their service life or the end of the shift in which they are first used, whichever occurs first, and (ii) A continuous monitoring and alarm system shall be provided where concentrations of vinyl chloride could reasonably exceed the allowable concentrations for the devices in use. Such system shall be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices in use.

(7) Apparatus prescribed for higher concentrations may be used for any lower concentration.

(h) "Hazardous operations." (1) Employees engaged in hazardous operations, including entry of vessels to clean polyvinyl chloride residue from vessel walls, shall be provided and required to wear and use;

(i) Respiratory protection in accordance with paragraphs (c) and (g) of this section; and

(ii) Protective garments to prevent skin contact with liquid vinyl chloride or with polyvinyl chloride residue from vessel walls. The protective garments shall be selected for the operation and its possible exposure conditions.

(2) Protective garments shall be provided clean and dry for each use. (i) "Emergency situations." A written operational plan for emergency situations shall be developed for each facility storing, handling, or otherwise using vinyl chloride as a liquid or compressed gas. Appropriate portions of the plan shall be implemented in the event of an emergency. The plan shall specifically provide that:

(1) Employees engaged in hazardous operations or correcting situations of existing hazardous releases shall be equipped as required in paragraph (h) of this section;

(2) Other employees not so equipped shall evacuate the area and not return until conditions are controlled by the methods required in paragraph (f) of this section and the emergency is abated.

(j) "Training." Each employee engaged in vinyl chloride or polyvinyl chloride operations shall be provided training in a program relating to the hazards of vinyl chloride and precautions for its safe use.

(1) The program shall include:

(i) The nature of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard;

(ii) The specific nature of operations which could result in exposure to vinyl chloride in excess of the permissible limit and necessary protective steps;

(iii) The purpose for, proper use, and limitations of respiratory protective devices;

(iv) The fire hazard and acute toxicity of vinyl chloride, and the necessary protective steps;

(v) The purpose for and a description of the monitoring program;

(vi) The purpose for, and a description of, the medical surveillance program;

(vii) Emergency procedures;

(viii) Specific information to aid the employee in recognition of conditions which may result in the release of vinyl chloride; and

(ix) A review of this standard at the employee's first training and indoctrination program, and annually thereafter.

(2) All materials relating to the program shall be provided upon request to the Assistant Secretary and the Director.

(k) "Medical surveillance." A program of medical surveillance shall be instituted for each employee exposed, without regard to the use of respirators, to vinyl chloride in excess of the action level. The program shall provide each such employee with an opportunity for examinations and tests in accordance with this paragraph. All medical examinations and procedures shall be performed by or under the supervision of a licensed physician, and shall be provided without cost to the employee.

(1) At the time of initial assignment, or upon institution of medical surveillance;

(i) A general physical examination shall be performed, with specific attention to detecting enlargement of liver, spleen or kidneys, or dysfunction in these organs, and for abnormalities in skin, connective tissues and the pulmonary system (See Appendix A).

(ii) A medical history shall be taken, including the following topics:

(A) Alcohol intake;

(B) Past history of hepatitis;

(D) Past history of blood transfusions; and

(E) Past history of hospitalizations.

(iii) A serum specimen shall be obtained and determinations made of: (A) Total bilirubin; (B) Alkaline phosphatase; (C) Serum glutamic oxalacetic transaminase (SGOT); (D) Serum glutamic pyruvic transaminase (SGPT); and (E) Gamma glustamyl transpeptidase.

(2) Examinations provided in accordance with this paragraph shall be performed at least:

(i) Every 6 months for each employee who has been employed in vinyl chloride or polyvinyl chloride manufacturing for 10 years or longer; and

(ii) Annually for all other employees.

(3) Each employee exposed to an emergency shall be afforded appropriate medical surveillance.

(4) A statement of each employee's suitability for continued exposure to vinyl chloride including use of protective equipment and respirators, shall be obtained from the examining physician promptly after any examination. A copy of the physician's statement shall be provided each employee.

(5) If any employee's health would be materially impaired by continued exposure, such employee shall be withdrawn from possible contact with vinyl chloride.

(6) Laboratory analyses for all biological specimens included in medical examinations shall be performed in laboratories licensed under 42 CFR part 74.

(7) If the examining physician determines that alternative medical examinations to those required by paragraph (k)(1) of this section will provide at least equal assurance of detecting medical conditions pertinent to the exposure to vinyl chloride, the employer may accept such alternative examinations as meeting the requirements of paragraph (k)(1) of this section, if the employer obtains a statement from the examining physician setting forth the alternative examinations and the rationale for substitution. This statement shall be available upon request for examination and copying to authorized representatives of the Assistant Secretary and the Director.

(l) "Signs and labels." (1) Entrances to regulated areas shall be posted with legible signs bearing the legend:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(2) Areas containing hazardous operations or where an emergency currently exists shall be posted with legible signs bearing the legend:

CANCER-SUSPECT AGENT
PROTECTIVE EQUIPMENT REQUIRED
AUTHORIZED PERSONNEL ONLY

(3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled:

CONTAMINATED WITH VINYL CHLORIDE
CANCER-SUSPECT AGENT

(4) Containers of polyvinyl chloride shall be legibly labeled:

POLYVINYL CHLORIDE (OR TRADE NAME)
CONTAINS VINYL CHLORIDE
VINYL CHLORIDE IS A CANCER-SUSPECT AGENT

(5) Containers of vinyl chloride shall be legibly labeled either:

(i)

VINYL CHLORIDE
EXTREMELY FLAMMABLE GAS UNDER PRESSURE
CANCER-SUSPECT AGENT

or (ii) In accordance with 49 CFR parts 170 through 189, with the additional legend:

CANCER-SUSPECT AGENT

applied near the label or placard.

(6) No statement shall appear on or near any required sign, label or instruction which contradicts or detracts from the effect of, any required warning, information or instruction.

(m) "Records." (1) All records maintained in accordance with this section shall include the name and social security number of each employee where relevant.

(2) Records of required monitoring and measuring and medical records shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a) through (e) and (g) through (i). These records shall be provided upon request to the Director. Authorized personnel rosters shall also be provided upon request to the Assistant Secretary and the Director.

(i) Monitoring and measuring records shall:

(A) State the date of such monitoring and measuring and the concentrations determined and identify the instruments and methods used;

(B) Include any additional information necessary to determine individual employee exposures where such exposures are determined by means other than individual monitoring of employees; and

(ii) [Reserved]

(iii) Medical records shall be maintained for the duration of the employment of each employee plus 20 years, or 30 years, whichever is longer.

(3) In the event that the employer ceases to do business and there is no successor to receive and retain his records for the prescribed period, these records shall be transmitted by registered mail to the Director, and each employee individually notified in writing of this transfer. The employer shall also comply with any additional requirements set forth in 29 CFR 1915.1120(h).

(n) "Reports." (1) Not later than 1 month after the establishment of a regulated area, the following information shall be reported to the OSHA Area Director. Any changes to such information shall be reported within 15 days.

(i) The address and location of each establishment which has one or more regulated areas; and

(ii) The number of employees in each regulated area during normal operations, including maintenance.

(2) Emergencies, and the facts obtainable at that time, shall be reported within 24 hours to the OSHA Area Director. Upon request of the Area Director, the employer shall submit additional information in writing relevant to the nature and extent of employee exposures and measures taken to prevent future emergencies of similar nature.

(3) Within 10 working days following any monitoring and measuring which discloses that any employee has been exposed, without regard to the use of respirators, in excess of the permissible exposure limit, each such employee shall be notified in writing of the results of the exposure measurement and the steps being taken to reduce the exposure to within the permissible exposure limit.

(o) "Effective dates." (1) Until April 1, 1975, the provisions currently set forth in 1910.93q of this part shall apply.

(2) Effective April 1, 1975, the provisions set forth in 1910.93q of this part shall apply.

(Approved by the Office of Management and Budget under control number 1218-0010)

[58 FR 35588, July 1, 1993]

1915.1017 Appendix A Supplementary Medical Information.

When required tests under paragraph (k)(1) of this section show abnormalities, the tests should be repeated as soon as practicable, preferably within 3 to 4 weeks. If tests remain abnormal, consideration should be given to withdrawal of the employee from contact with vinyl chloride, while a more comprehensive examination is made. Additional tests which may be useful:

A. For kidney dysfunction: urine examination for albumin, red blood cells, and exfoliative abnormal cells.

B. Pulmonary system: Forced vital capacity, Forced expiratory volume at 1 second, and chest roentgenogram (posterioranterior, 14 X 17 inches (35.56 X 43.18 cm)).

C. Additional serum tests: Lactic acid dehydrogenase, lactic acid dehydrogenase isoenzyme, protein determination, and protein electrophoresis.

D. For a more comprehensive examination on repeated abnormal serum tests: Hepatitis B antigen, and liver scanning.

[58 FR 35591, July 1, 1993]

1915.1018 Inorganic arsenic.

(a) "Scope and application." This section applies to all occupational exposures to inorganic arsenic except that this section does not apply to employee exposures in agriculture or resulting from pesticide application, the treatment of wood with preservatives or the utilization of arsenically preserved wood.

(b) "Definitions." Action level means a concentration of inorganic arsenic of 5 micrograms per cubic meter of air (5 ug/m(3)) averaged over any eight (8) hour period.

"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.

"Authorized person" means any person specifically authorized by the employer whose duties require the person to enter a regulated area, or any person entering such an area as a designated representative of employees for the purpose of exercising the right to observe monitoring and measuring procedures under paragraph (e) of this section.

"Director" means the Director, National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services or designee.

"Inorganic arsenic" means copper aceto-arsenite and all inorganic compounds containing arsenic except arsine, measured as arsenic (As).

(c) "Permissible exposure limit." The employer shall assure that no employee is exposed to inorganic arsenic at concentrations greater than 10 micrograms per cubic meter of air (10 ug/m(3)), averaged over any 8-hour period.

(d) "Notification of use." (1) By October 1, 1978 or within 60 days after the introduction of inorganic arsenic into the workplace, every employer who is required to establish a regulated area in his workplaces shall report in writing to the OSHA area office for each such workplace:

(i) The address of each such workplace;

(ii) The approximate number of employees who will be working in regulated areas; and

(iii) A brief summary of the operations creating the exposure and the actions which the employer intends to take to reduce exposures.

(2) Whenever there has been a significant change in the information required by paragraph (d)(1) of this section the employer shall report the changes in writing within 60 days to the OSHA area office.

(e) "Exposure monitoring" - (1) "General." (i) Determinations of airborne exposure levels shall be made from air samples that are representative of each employee's exposure to inorganic arsenic over an eight (8) hour period.

(ii) For the purposes of this section, employee exposure is that exposure which would occur if the employee were not using a respirator.

(iii) The employer shall collect full shift (for at least 7 continuous hours) personal samples including at least one sample for each shift for each job classification in each work area.

(2) "Initial monitoring." Each employer who has a workplace or work operation covered by this standard shall monitor each such workplace and work operation to accurately determine the airborne concentration of inorganic arsenic to which employees may be exposed.

(3) "Frequency." (i) If the initial monitoring reveals employee exposure to be below the action level the measurements need not be repeated except as otherwise provided in paragraph (e)(4) of this section.

(ii) If the initial monitoring, required by this section, or subsequent monitoring reveals employee exposure to be above the permissible exposure limit, the employer shall repeat monitoring at least quarterly.

(iii) If the initial monitoring, required by this section, or subsequent monitoring reveals employee exposure to be above the action level and below the permissible exposure limit the employer shall repeat monitoring at least every six months.

(iv) The employer shall continue monitoring at the required frequency until at least two consecutive measurements, taken at least seven (7) days apart, are below the action level at which time the employer may discontinue monitoring for that employee until such time as any of the events in paragraph (e)(4) of this section occur.

(4) "Additional monitoring." Whenever there has been a production, process, control or personal change which may result in new or additional exposure to inorganic arsenic, or whenever the employer has any other reason to suspect a change which may result in new or additional exposures to inorganic arsenic, additional monitoring which complies with paragraph (e) of this section shall be conducted.

(5) "Employee notification." (i) Within five (5) working days after the receipt of monitoring results, the employer shall notify each employee in writing of the results which represent that employee's exposures.

(ii) Whenever the results indicate that the representative employee exposure exceeds the permissible exposure limit, the employer shall include in the written notice a statement that the permissible exposure limit was exceeded and a description of the corrective action taken to reduce exposure to or below the permissible exposure limit.

(6) "Accuracy of measurement." (i) The employer shall use a method of monitoring and measurement which has an accuracy (with a confidence level of 95 percent) of not less than plus or minus 25 percent for concentrations of inorganic arsenic greater than or equal to 10 ug/m(3).

(ii) The employer shall use a method of monitoring and measurement which has an accuracy (with confidence level of 95 percent) of not less than plus or minus 35 percent for concentrations of inorganic arsenic greater than 5 ug/m(3) but less than 10 ug/m(3).

(f) "Regulated area" - (1) "Establishment." The employer shall establish regulated areas where worker exposures to inorganic arsenic, without regard to the use of respirators, are in excess of the permissible limit.

(2) "Demarcation." Regulated areas shall be demarcated and segregated from the rest of the workplace in any manner that minimizes the number of persons who will be exposed to inorganic arsenic.

(3) "Access." Access to regulated areas shall be limited to authorized persons or to persons otherwise authorized by the Act or regulations issued pursuant thereto to enter such areas.

(4) "Provision of respirators." All persons entering a regulated area shall be supplied with a respirator, selected in accordance with paragraph (h)(2) of this section.

(5) "Prohibited activities." The employer shall assure that in regulated areas, food or beverages are not consumed, smoking products, chewing tobacco and gum are not used and cosmetics are not applied, except that these activities may be conducted in the lunchrooms, change rooms and showers required under paragraph (m) of this section. Drinking water may be consumed in the regulated area.

(g) "Methods of compliance" - (1) "Controls." (i) The employer shall institute at the earliest possible time but not later than December 31, 1979, engineering and work practice controls to reduce exposures to or below the permissible exposure limit, except to the extent that the employer can establish that such controls are not feasible.

(ii) Where engineering and work practice controls are not sufficient to reduce exposures to or below the permissible exposure limit, they shall nonetheless be used to reduce exposures to the lowest levels achievable by these controls and shall be supplemented by the use of respirators in accordance with paragraph (h) of this section and other necessary personal protective equipment. Employee rotation is not required as a control strategy before respiratory protection is instituted.

(2) "Compliance Program." (i) The employer shall establish and implement a written program to reduce exposures to or below the permissible exposure limit by means of engineering and work practice controls.

(ii) Written plans for these compliance programs shall include at least the following:

(A) A description of each operation in which inorganic arsenic is emitted; e.g. machinery used, material processed, controls in place, crew size, operating procedures and maintenance practices;

(B) Engineering plans and studies used to determine methods selected for controlling exposure to inorganic arsenic;

(D) Monitoring data;

(E) A detailed schedule for implementation of the engineering controls and work practices that cannot be implemented immediately and for the adaption and implementation of any additional engineering and work practices necessary to meet the permissible exposure limit;

(F) Whenever the employer will not achieve the permissible exposure limit with engineering controls and work practices by December 31, 1979, the employer shall include in the compliance plan an analysis of the effectiveness of the various controls, shall install engineering controls and institute work practices on the quickest schedule feasible, and shall include in the compliance plan and implement a program to minimize the discomfort and maximize the effectiveness of respirator use; and

(G) Other relevant information.

(iii) Written plans for such a program shall be submitted upon request to the Assistant Secretary and the Director, and shall be available at the worksite for examination and copying by the Assistant Secretary, Director, any affected employee or authorized employee representatives.

(iv) The plans required by this paragraph shall be revised and updated at least every 6 months to reflect the current status of the program.

(h) "Respiratory protection" - (1) "General." The employer shall assure that respirators are used where required under this section to reduce employee exposures to below the permissible exposure limit and in emergencies. Respirators shall be used in the following circumstances:

(i) During the time period necessary to install or implement feasible engineering or work practice controls;

(ii) In work operations such as maintenance and repair activities in which the employer establishes that engineering and work practice controls are not feasible;

(iii) In work situations in which engineering controls and supplemental work practice controls are not yet sufficient to reduce exposures to or below the permissible exposure limit; or (iv) In emergencies. (2) "Respirator selection." (i) Where respirators are required under this section the employer shall select, provide at no cost to the employee and assure the use of the appropriate respirator or combination of respirators from Table I below for inorganic arsenic compounds without significant vapor pressure, or Table II below for inorganic arsenic compounds which have significant vapor pressure.

(ii) Where employee exposures exceed the permissible exposure limit for inorganic arsenic and also exceed the relevant limit for particular gasses such as sulfur dioxide, any air purifying respirator supplied to the employee as permitted by this standard must have a combination high efficiency filter with an appropriate gas sorbent. (See footnote in Table 1)

TABLE I - RESPIRATORY PROTECTION FOR INORGANIC ARSENIC PARTICULATE EXCEPT FOR THOSE WITH SIGNIFICANT VAPOR PRESSURE
Concentration of inorganic arsenic (as As) or condition of use	Required respirator
(i) Unknown or greater or lesser than 20,000 ug/m(3) (20 mg/m(3)) or firefighting	(A) Any full facepiece self-contained breathing apparatus operated in positive pressure mode
(ii) Not greater than 20,000 ug/m(3) (20 mg/m(3))	(A) Supplied air respirator with full facepiece, hood, or helmet or suit and operated in positive pressure mode
(iii) Not greater than 10,000 ug/m(3) (10 mg/m(3))	(A) Powered air-purifying respirators in all inlet face coverings with high efficiency filters.(1) (B) Half-mask supplied air respirators operated in positive pressure mode
(iv) Not greater than 500 ug/m(3)	(A) Full facepiece air-purifying respirator equipped with high-efficiency filter.(1) (B) Any full facepiece supplied air respirator. (C) Any full facepiece self-contained breathing apparatus
(v) Not greater than 100 ug/m(3)	(A) Half-mask air-purifying respirator equipped with high-efficiency filter.(1) (B) Any half-mask supplied air respirator
Footnote(1) High-efficiency filter - 99.97 percent efficiency against 0.3 micrometer monodisperse diethyl-hexyl phthalate (DOP) particles.

TABLE II - RESPIRATORY PROTECTION FOR INORGANIC ARSENICALS (SUCH AS ARSENIC TRICHLORIDE(2) AND ARSENIC PHOSPHIDE) WITH SIGNIFICANT VAPOR PRESSURE
Concentration of inorganic arsenic (as As) or condition of use	Required respirator
(i) Unknown or greater or lesser than 20,000 ug/m(3) (20 mg/m(3))or firefighting	(A) Any full facepiece self-contained breathing apparatus operated in positive pressure mode
(ii) Not greater than 20,000 ug/m(3) (20 mg/m(3))	(A) Supplied air respirator with full facepiece hood, or helmet or suit and operated in positive pressure mode
(iii) Not greater than 10,000 ug/m(3) (10 mg/m(3))	(A) Half-mask(2) supplied air respirator operated in positive pressure mode
(iv) Not greater than 500 ug/m(3)	(A) Front or back mounted gas mask equipped with high-efficiency filter(1) and acid gas canister (B) Any full facepiece supplied air respirator. (C) Any full facepiece self-contained breathing apparatus
(v) Not greater than 100 ug/m(3)	(A) Half-mask(2) air-purifying respirator equipped with high-efficiency filter(1) and acid gas cartridge. (B) Any half-mask supplied air respirator

Footnote(1) High efficiency filter - 99.97 percent efficiency against 0.3 micrometer monodisperse diethyl-hexyl phthalate (DOP) particles.

Footnote(2) Half-mask respirators shall not be used for protection against arsenic trichloride, as it is rapidly absorbed through the skin.

(iii) The employer shall select respirators from among those approved for protection against dust, fume, and mist by the National Institute for Occupational Safety and Health (NIOSH) under the provisions of 30 CFR part 11.

(3) "Respirator usage." (i) The employer shall assure that the respirator issued to the employee exhibits minimum facepiece leakage and that the respirator is fitted properly.

(ii) The employer shall perform qualitative fit tests at the time of initial fitting and at least semi-annually thereafter for each employee wearing respirators, where quantitative fit tests are not required.

(iii) Employers with more than 20 employees wearing respirators shall perform a quantitative face fit test at the time of initial fitting and least semi-annually thereafter for each employee wearing negative pressure respirators. The test shall be used to select facepieces that provide the required protection as prescribed in Table I or II.

(iv) If an employee has demonstrated difficulty in breathing during the fitting test or during use, he or she shall be examined by a physician trained in pulmonary medicine to determine whether the employee can wear a respirator while performing the required duty.

(4) "Respirator program." (i) The employer shall institute a respiratory protection program in accordance with 29 CFR 1910.134(b), (d), (e) and (f).

(iii) Employees who wear respirators shall be permitted to leave work areas to wash their face and respirator facepiece to prevent skin irritation associated with respirator use.

(5) "Commencement of respirator use." (i) The employer's obligation to provide respirators commences on August 1, 1978 for employees exposed over 500 ug/m(3) of inorganic arsenic, as soon as possible but not later than October 1, 1978 for employees exposed to over 50 ug/m(3) of inorganic arsenic, and as soon as possible but not later than December 1, 1978 for employees exposed between 10 and 50 ug/m(3) of inorganic arsenic.

(ii) Employees with exposures below 50 ug/m(3) of inorganic arsenic may choose not to wear respirators until December 31, 1979.

(iii) After December 1, 1978 any employee required to wear air-purifying respirators may choose, and if so chosen the employer must provide, if it will give proper protection, a powered air purifying respirator and in addition if necessary a combination dust and acid gas respirator for times where exposures to gases are over the relevant exposure limits.

(i) [Reserved]

(j) "Protective work clothing and equipment" - (1) "Provision and use."

Where the possibility of skin or eye irritation from inorganic arsenic exists, and for all workers working in regulated areas, the employer shall provide at no cost to the employee and assure that employees use appropriate and clean protective work clothing and equipment such as, but not limited to:

(i) Coveralls or similar full-body work clothing;

(ii) Gloves, and shoes or coverlets;

(iii) Face shields or vented goggles when necessary to prevent eye irritation, which comply with the requirements of 1915.133(a)(2)-(6); and

(iv) Impervious clothing for employees subject to exposure to arsenic trichloride.

(2) "Cleaning and replacement." (i) The employer shall provide the protective clothing required in paragraph (j)(1) of this section in a freshly laundered and dry condition at least weekly, and daily if the employee works in areas where exposures are over 100 ug/m(3) of inorganic arsenic or in areas where more frequent washing is needed to prevent skin irritation.

(ii) The employer shall clean, launder, or dispose of protective clothing required by paragraph (j)(1) of this section.

(iii) The employer shall repair or replace the protective clothing and equipment as needed to maintain their effectiveness.

(iv) The employer shall assure that all protective clothing is removed at the completion of a work shift only in change rooms prescribed in paragraph (m)(1) of this section.

(v) The employer shall assure that contaminated protective clothing which is to be cleaned, laundered, or disposed of, is placed in a closed container in the change-room which prevents dispersion of inorganic arsenic outside the container.

(vi) The employer shall inform in writing any person who cleans or launders clothing required by this section, of the potentially harmful effects including the carcinogenic effects of exposure to inorganic arsenic.

(vii) The employer shall assure that the containers of contaminated protective clothing and equipment in the workplace or which are to be removed from the workplace are labelled as follows:

Caution: Clothing contaminated with inorganic arsenic; do not remove dust by blowing or shaking. Dispose of inorganic arsenic contaminated wash water in accordance with applicable local, State or Federal regulations.

(viii) The employer shall prohibit the removal of inorganic arsenic from protective clothing or equipment by blowing or shaking.

(k) "Housekeeping" - (1) "Surfaces." All surfaces shall be maintained as free as practicable of accumulations of inorganic arsenic.

(2) "Cleaning floors." Floors and other accessible surfaces contaminated with inorganic arsenic may not be cleaned by the use of compressed air, and shoveling and brushing may be used only where vacuuming or other relevant methods have been tried and found not to be effective.

(3) "Vacuuming." Where vacuuming methods are selected, the vacuums shall be used and emptied in a manner to minimize the reentry of inorganic arsenic into the workplace.

(4) "Housekeeping plan." A written housekeeping and maintenance plan shall be kept which shall list appropriate frequencies for carrying out housekeeping operations, and for cleaning and maintaining dust collection equipment. The plan shall be available for inspection by the Assistant Secretary.

(5) "Maintenance of equipment." Periodic cleaning of dust collection and ventilation equipment and checks of their effectiveness shall be carried out to maintain the effectiveness of the system and a notation kept of the last check of effectiveness and cleaning or maintenance.

(l) [Reserved]

(m) "Hygiene facilities and practices" - (1) "Change rooms." The employer shall provide for employees working in regulated areas or subject to the possibility of skin or eye irritation from inorganic arsenic, clean change rooms equipped with storage facilities for street clothes and separate storage facilities for protective clothing and equipment in accordance with 29 CFR 1910.141(e).

(2) "Showers." (i) The employer shall assure that employees working in regulated areas or subject to the possibility of skin or eye irritation from inorganic arsenic shower at the end of the work shift.

(ii) The employer shall provide shower facilities in accordance with 1910.141(d)(3).

(3) "Lunchrooms." (i) The employer shall provide for employees working in regulated areas, lunchroom facilities which have a temperature controlled, positive pressure, filtered air supply, and which are readily accessible to employees working in regulated areas.

(ii) The employer shall assure that employees working in the regulated area or subject to the possibility of skin or eye irritation from exposure to inorganic arsenic wash their hands and face prior to eating.

(4) "Lavatories." The employer shall provide lavatory facilities which comply with 1910.141(d)(1) and (2)(ii) through (vii).

(5) "Vacuuming clothes." The employer shall provide facilities for employees working in areas where exposure, without regard to the use of respirators, exceeds 100 ug/m(3) to vacuum their protective clothing and clean or change shoes worn in such areas before entering change rooms, lunchrooms or shower rooms required by paragraph (j) of this section and shall assure that such employees use such facilities.

(6) "Avoidance of skin irritation." The employer shall assure that no employee is exposed to skin or eye contact with arsenic trichloride, or to skin or eye contact with liquid or particulate inorganic arsenic which is likely to cause skin or eye irritation.

(n) "Medical surveillance" - (1) "General" - (i) "Employees covered."

The employer shall institute a medical surveillance program for the following employees:

(A) All employees who are or will be exposed above the action level, without regard to the use of respirators, at least 30 days per year; and

(B) All employees who have been exposed above the action level, without regard to respirator use, for 30 days or more per year for a total of 10 years or more of combined employment with the employer or predecessor employers prior to or after the effective date of this standard. The determination of exposures prior to the effective date of this standard shall be based upon prior exposure records, comparison with the first measurements taken after the effective date of this standard, or comparison with records of exposures in areas with similar processes, extent of engineering controls utilized and materials used by that employer.

(ii) "Examination by physician." The employer shall assure that all medical examinations and procedures are performed by or under the supervision of a licensed physician, and shall be provided without cost to the employee, without loss of pay and at a reasonable time and place.

(2) "Initial examinations." By December 1, 1978, for employees initially covered by the medical provisions of this section, or thereafter at the time of initial assignment to an area where the employee is likely to be exposed over the action level at least 30 days per year, the employer shall provide each affected employee an opportunity for a medical examination, including at least the following elements:

(i) A work history and a medical history which shall include a smoking history and the presence and degree of respiratory symptoms such as breathlessness, cough, sputum production and wheezing.

(ii) A medical examination which shall include at least the following:

(A) A 14" by 17" (35.56 X 43.18 cm) posterior-anterior chest X-ray and International Labor Office UICC/Cincinnati (ILO U/C) rating;

(B) A nasal and skin examination;

(D) Other examinations which the physician believes appropriate because of the employees exposure to inorganic arsenic or because of required respirator use.

(3) "Periodic examinations." (i) The employer shall provide the examinations specified in paragraphs (n)(2)(i) and (n)(2)(ii) (A), (B), and (D) at least annually for covered employees who are under 45 years of age with fewer than 10 years of exposure over the action level without regard to respirator use.

(ii) The employer shall provide the examinations specified in paragraphs (n)(2)(i) and (n)(2)(ii) of this section at least semi-annually for other covered employees.

(iii) Whenever a covered employee has not taken the examinations specified in paragraphs (n)(2)(i) and (n)(2)(ii) of this section within six (6) months preceding the termination of employment, the employer shall provide such examinations to the employee upon termination of employment.

(4) "Additional examinations." If the employee for any reason develops signs or symptoms commonly associated with exposure to inorganic arsenic the employer shall provide an appropriate examination and emergency medical treatment.

(5) "Information provided to the physician." The employer shall provide the following information to the examining physician:

(i) A copy of this standard and its appendices;

(ii) A description of the affected employee's duties as they relate to the employee's exposure;

(iii) The employee's representative exposure level or anticipated exposure level;

(iv) A description of any personal protective equipment used or to be used; and

(v) Information from previous medical examinations of the affected employee which is not readily available to the examining physician.

(6) "Physician's written opinion." (i) The employer shall obtain a written opinion from the examining physician which shall include:

(A) The results of the medical examination and tests performed;

(B) The physician's opinion as to whether the employee has any detected medical conditions which would place the employee at increased risk of material impairment of the employee's health from exposure to inorganic arsenic;

(C) Any recommended limitations upon the employee's exposure to inorganic arsenic or upon the use of protective clothing or equipment such as respirators; and

(D) A statement that the employee has been informed by the physician of the results of the medical examination and any medical conditions which require further explanation or treatment.

(ii) The employer shall instruct the physician not to reveal in the written opinion specific findings or diagnoses unrelated to occupational exposure.

(iii) The employer shall provide a copy of the written opinion to the affected employee.

(o) "Employee information and training" - (1) "Training program." (i) The employer shall institute a training program for all employees who are subject to exposure to inorganic arsenic above the action level without regard to respirator use, or for whom there is the possibility of skin or eye irritation from inorganic arsenic. The employer shall assure that those employees participate in the training program.

(ii) The training program shall be provided by October 1, 1978, for employees covered by this provision, at the time of initial assignment for those subsequently covered by this provision, and shall be repeated at least quarterly for employees who have optional use of respirators and at least annually for other covered employees thereafter; and the employer shall assure that each employee is informed of the following:

(A) The information contained in Appendix A;

(B) The quantity, location, manner of use, storage, sources of exposure, and the specific nature of operations which could result in exposure to inorganic arsenic as well as any necessary protective steps;

(D) The purpose and a description of the medical surveillance program as required by paragraph (n) of this section;

(E) The engineering controls and work practices associated with the employee's job assignment; and

(F) A review of this standard.

(2) "Access to training materials." (i) The employer shall make readily available to all affected employees a copy of this standard and its appendices.

(ii) The employer shall provide; upon request, all materials relating to the employee information and training program to the Assistant Secretary and the Director.

(p) "Signs and labels" - (1) "General." (i) The employer may use labels or signs required by other statutes, regulations, or ordinances in addition to, or in combination with, signs and labels required by this paragraph.

(ii) The employer shall assure that no statement appears on or near any sign or label required by this paragraph which contradicts or detracts from the meaning of the required sign or label.

(2) "Signs." (i) The employer shall post signs demarcating regulated areas bearing the legend;

DANGER
INORGANIC ARSENIC
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
NO SMOKING OR EATING
RESPIRATOR REQUIRED

(ii) The employer shall assure that signs required by this paragraph are illuminated and cleaned as necessary so that the legend is readily visible.

(3) "Labels." The employer shall apply precautionary labels to all shipping and storage containers of inorganic arsenic, and to all products containing inorganic arsenic except when the inorganic arsenic in the product is bound in such a manner so as to make unlikely the possibility of airborne exposure to inorganic arsenic. (Possible examples of products not requiring labels are semiconductors, light emitting diodes and glass). The label shall bear the following legend:

DANGER
CONTAINS INORGANIC ARSENIC
CANCER HAZARD
HARMFUL IF INHALED OR SWALLOWED
USE ONLY WITH ADEQUATE VENTILATION
OR RESPIRATORY PROTECTION

(q) "Recordkeeping" - (1) "Exposure monitoring." (i) The employer shall establish and maintain an accurate record of all monitoring required by paragraph (e) of this section.

(ii) This record shall include:

(A) The date(s), number, duration location, and results of each of the samples taken, including a description of the sampling procedure used to determine representative employee exposure where applicable;

(B) A description of the sampling and analytical methods used and evidence of their accuracy;

(D) Name, social security number, and job classification of the employees monitored and of all other employees whose exposure the measurement is intended to represent; and

(E) The environmental variables that could affect the measurement of the employee's exposure.

(iii) The employer shall maintain these monitoring records for at least 40 years or for the duration of employment plus 20 years, whichever, is longer.

(2) "Medical surveillance." (i) The employer shall establish and maintain an accurate record for each employee subject to medical surveillance as required by paragraph (n) of this section.

(ii) This record shall include:

(A) The name, social security number, and description of duties of the employee;

(B) A copy of the physician's written opinions;

(C) Results of any exposure monitoring done for that employee and the representative exposure levels supplied to the physician; and

(D) Any employee medical complaints related to exposure to inorganic arsenic.

(iii) The employer shall in addition keep, or assure that the examining physician keeps, the following medical records;

(A) A copy of the medical examination results including medical and work history required under paragraph (n) of this section;

(B) A description of the laboratory procedures and a copy of any standards or guidelines used to interpret the test results or references to that information;

(D) The X-rays for the most recent 5 years;

(E) Any X-rays with a demonstrated abnormality and all subsequent X-rays;

(F) The initial cytologic examination slide and written description;

(G) The cytologic examination slide and written description for the most recent 5 years; and

(H) Any cytologic examination slides with demonstrated atypia, if such atypia persists for 3 years, and all subsequent slides and written descriptions.

(iv) The employer shall maintain or assure that the physician maintains those medical records for at least 40 years, or for the duration of employment plus 20 years whichever is longer.

(3) "Availability." (i) The employer shall make available upon request all records required to be maintained by paragraph (q) of this section to the Assistant Secretary and the Director for examination and copying.

(4) "Transfer of records." (i) Whenever the employer ceases to do business, the successor employer shall receive and retain all records required to be maintained by this section.

(ii) Whenever the employer ceases to do business and there is no successor employer to receive and retain the records required to be maintained by this section for the prescribed period, these records shall be transmitted to the Director.

(iii) At the expiration of the retention period for the records required to be maintained by this section, the employer shall notify the Director at least 3 months prior to the disposal of such records and shall transmit those records to the Director if he requests them within that period.

(iv) The employer shall also comply with any additional requirements involving the transfer of records set in 29 CFR 1915.1120(h).

(r) "Observation of monitoring" - (1) "Employee observation." The employer shall provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to inorganic arsenic conducted pursuant to paragraph (e) of this section.

(2) "Observation procedures." (i) Whenever observation of the monitoring of employee exposure to inorganic arsenic requires entry into an area where the use of respirators, protective clothing, or equipment is required, the employer shall provide the observer with and assure the use of such respirators, clothing, and such equipment, and shall require the observer to comply with all other applicable safety and health procedures.

(ii) Without interfering with the monitoring, observers shall be entitled to;

(A) Receive an explanation of the measurement procedures;

(B) Observe all steps related to the monitoring of inorganic arsenic performed at the place of exposure; and

(s) "Effective date." This standard shall become effective August 1, 1978.

(t) "Appendices." The information contained in the appendices to this section is not intended by itself, to create any additional obligations not otherwise imposed by this standard nor detract from any existing obligation.

(u) "Startup dates" - (1) "General." The startup dates of requirements of this standard shall be the effective date of this standard unless another startup date is provided for either in other paragraphs of this section or in this paragraph.

(2) "Monitoring." Initial monitoring shall be commenced on August 1, 1978, and shall be completed by September 15, 1978.

(3) "Regulated areas." Regulated areas required to be established as a result of initial monitoring shall be set up as soon as possible after the results of that monitoring is known and no later than October 1, 1978.

(4) "Compliance program." The written program required by paragraph (g)(2) as a result of initial monitoring shall be made available for inspection and copying as soon as possible and no later than December 1, 1978.

(5) "Hygiene and lunchroom facilities." Construction plans for change- rooms, showers, lavatories, and lunchroom facilities shall be completed no later than December 1, 1978, and these facilities shall be constructed and in use no later than July 1, 1979. However, if as part of the compliance plan it is predicted by an independent engineering firm that engineering controls and work practices will reduce exposures below the permissible exposure limit by December 31, 1979, for affected employees, then such facilities need not be completed until 1 year after the engineering controls are completed or December 31, 1980, whichever is earlier, if such controls have not in fact succeeded in reducing exposure to below the permissible exposure limit.

(6) "Summary of startup dates set forth elsewhere in this standard."

"Startup Dates"

August 1, 1978 - Respirator use over 500 ug/m(3).

"as soon as possible but no later than"

September 15, 1978 - Completion of initial monitoring. October 1, 1978 - Complete establishment of regulated areas. Respirator use for employees exposed above 50 ug/m(3). Completion of initial training. Notification of use.

December 1, 1978 - Respirator use over 10 ug/m(3). Completion of initial medical. Completion of compliance plan. Optional use of powered air-purifying respirators.

July 1, 1979 - Completion of lunch rooms and hygiene facilities. December 31, 1979 - Completion of engineering controls.

All other requirements of the standard have as their startup date August 1, 1978.

(Approved by the Office of Management and Budget under control number 1218-0104)

[58 FR 35591, July 1, 1993]

1915.1018 Appendix A Inorganic Arsenic Substance Information Sheet.

I. SUBSTANCE IDENTIFICATION

A. "Substance." Inorganic Arsenic.

B. "Definition." Copper acetoarsenite, arsenic and all inorganic compounds containing arsenic except arsine, measured as arsenic (As).

C. "Permissible Exposure Limit." 10 micrograms per cubic meter of air as determined as an average over an 8-hour period. No employee may be exposed to any skin or eye contact with arsenic trichloride or to skin or eye contact likely to cause skin or eye irritation.

D. "Regulated Areas." Only employees authorized by your employer should enter a regulated area.

II. HEALTH HAZARD DATA

A. "Comments." The health hazard of inorganic arsenic is high.

B. "Ways in which the chemical affects your body." Exposure to airborne concentrations of inorganic arsenic may cause lung cancer, and can be a skin irritant. Inorganic arsenic may also affect your body if swallowed. One compound in particular, arsenic trichloride, is especially dangerous because it can be absorbed readily through the skin. Because inorganic arsenic is a poison, you should wash your hands thoroughly prior to eating or smoking.

III. PROTECTIVE CLOTHING AND EQUIPMENT

A. "Respirators." Respirators will be provided by your employer at no cost to you for routine use if your employer is in the process of implementing engineering and work practice controls or where engineering and work practice controls are not feasible or insufficient. You must wear respirators for non-routine activities or in emergency situations where you are likely to be exposed to levels of inorganic arsenic in excess of the permissible exposure limit. Since how well your respirator fits your face is very important, your employer is required to conduct fit tests to make sure the respirator seals properly when you wear it. These tests are simple and rapid and will be explained to you during training sessions.

B. "Protective clothing." If you work in a regulated area, your employer is required to provide at no cost to you, and you must wear, appropriate, clean, protective clothing and equipment. The purpose of this equipment is to prevent you from bringing to your home arsenic-contaminated dust and to protect your body from repeated skin contact with inorganic arsenic likely to cause skin irritation. This clothing should include such items as coveralls or similar full-body clothing, gloves, shoes or coverlets, and aprons. Protective equipment should include face shields or vented goggles, where eye irritation may occur.

IV. HYGIENE FACILITIES AND PRACTICES

You must not eat, drink, smoke, chew gum or tobacco, or apply cosmetics in the regulated area, except that drinking water is permitted. If you work in a regulated area your employer is required to provide lunchrooms and other areas for these purposes.

If you work in a regulated area, your employer is required to provide showers, washing facilities, and change rooms. You must wash your face, and hands before eating and must shower at the end of the work shift. Do not take used protective clothing out of change rooms without your employer's permission. Your employer is required to provide for laundering or cleaning of your protective clothing.

V. SIGNS AND LABELS

Your employer is required to post warning signs and labels for your protection. Signs must be posted in regulated areas. The signs must warn that a cancer hazard is present, that only authorized employees may enter the area, and that no smoking or eating is allowed, and that respirators must be worn.

VI. MEDICAL EXAMINATIONS

If your exposure to arsenic is over the Action Level (5 ug/m(3)) - (including all persons working in regulated areas) at least 30 days per year, or you have been exposed to arsenic for more than 10 years over the Action Level, your employer is required to provide you with a medical examination. The examination shall be every 6 months for employees over 45 years old or with more than 10 years exposure over the Action Level and annually for other covered employees. The medical examination must include a medical history; a chest x-ray; skin examination; nasal examination and sputum cytology exam for the early detection of lung cancer. The cytology exams are only included in the initial exam and examinations given after you are either 45 years or older or have 10 or more years employment over the Action Level. The examining physician will provide a written opinion to your employer containing the results of the medical exams. You should also receive a copy of this opinion. The physician must not tell your employer any conditions he detects unrelated to occupational exposure to arsenic but must tell you those conditions.

VII. OBSERVATION OF MONITORING

Your employer is required to monitor your exposure to arsenic and you or your representatives are entitled to observe the monitoring procedure. You are entitled to receive an explanation of the measurement procedure, and to record the results obtained. When the monitoring procedure is taking place in an area where respirators or personal protective clothing and equipment are required to be worn, you must also be provided with and must wear the protective clothing and equipment.

VIII. ACCESS TO RECORDS

You or your representative are entitled to records of your exposure to inorganic arsenic and your medical examination records if you request your employer to provide them.

IX. TRAINING AND NOTIFICATION

Additional information on all of these items plus training as to hazards of exposure to inorganic arsenic and the engineering and work practice controls associated with your job will also be provided by your employer. If you are exposed over the permissible exposure limit, your employer must inform you of that fact and the actions he is taking to reduce your exposures.

[58 FR 35596, July 1. 1993]

1915.1018 Appendix B Substance Technical Guidelines

ARSENIC, ARSENIC TRIOXIDE, ARSENIC TRICHLORIDE (THREE EXAMPLES)

I. "Physical and chemical properties"

1. Formula: As. 2. Appearance: Gray metal. 3. Melting point: Sublimes without melting at 613 deg. C. 4. Specific Gravity: (H(2)O=1):5.73. 5. Solubility in water: Insoluble.

1. Formula: As2O3, (As4O6). 2. Appearance: White powder. 3. Melting point: 315 deg. C. 4. Specific Gravity (H(2)O=1):3.74. 5. Solubility in water: 3.7 grams in 100cc of water at 20 deg. C.

1. Formula: AsC 13. 2. Appearance: Colorless or pale yellow liquid. 3. Melting point: -8.5 deg. C. 4. Boiling point: 130.2 deg. C. 5. Specific Gravity (H(2)O=1):2.16 at 20 deg. C. 6. Vapor Pressure: 10mm Hg at 23.5 deg. C. 7. Solubility in Water: Decomposes in water.

II. "Fire, explosion and reactivity data."

A. Fire: Arsenic, Arsenic Trioxide and Arsenic Trichloride are nonflammable.

B. Reactivity:

1. Conditions Contributing to instability: Heat.

2. Incompatibility: Hydrogen gas can react with inorganic arsenic to form the highly toxic gas arsine.

III. "Monitoring and Measurement Procedures"

Samples collected should be full shift (at least 7-hour) samples. Sampling should be done using a personal sampling pump at a flow rate of 2 liters per minute. Samples should be collected on 0.8 micrometer pore size membrane filter (37mm diameter). Volatile arsenicals such as arsenic trichloride can be most easily collected in a midget bubbler filled with 15 ml. of 0.1 N NaOH.

The method of sampling and analysis should have an accuracy of not less than plus or minus 25 percent (with a confidence limit of 95 percent) for 10 micrograms per cubic meter of air (10 ug/m(3)) and plus or minus 35 percent (with a confidence limit of 95 percent) for concentrations of inorganic arsenic between 5 and 10 ug/m(3).

[58 FR 35597, July 1, 1993]

1915.1018 Appendix C Medical Surveillance Guidelines

I. GENERAL

Medical examinations are to be provided for all employees exposed to levels of inorganic arsenic above the action level (5 ug/m(3)) for at least 30 days per year (which would include among others, all employees, who work in regulated areas). Examinations are also to be provided to all employees who have had 10 years or more exposure above the action level for more than 30 days per year while working for the present or predecessor employer though they may no longer be exposed above the level.

An initial medical examination is to be provided to all such employees by December 1, 1978. In addition, an initial medical examination is to be provided to all employees who are first assigned to areas in which worker exposure will probably exceed 5 ug/m(3) (after the effective date of this standard) at the time of initial assignment. In addition to its immediate diagnostic usefulness, the initial examination will provide a baseline for comparing future test results. The initial examination must include as a minimum the following elements:

(1) A work and medical history, including a smoking history, and presence and degree of respiratory symptoms such as breathlessness, cough, sputum production, and wheezing;

(2) A 14" by 17" (35.56 X 43.18 cm) posterior-anterior chest X-ray and an International Labor Office UICC/Cincinnati (ILO U/C) rating;

(3) A nasal and skin examination;

(4) A Sputum Cytology examination; and

(5) Other examinations which the physician believes appropriate because of the employee's exposure to inorganic arsenic or because of required respirator use.

Periodic examinations are also to be provided to the employees listed above. The periodic examinations shall be given annually for those covered employees 45 years of age or less with fewer than 10 years employment in areas where employee exposure exceeds the action level (5 ug/m(3)). Periodic examinations need not include sputum cytology and only an updated medical history is required.

Periodic examinations for other covered employees, shall be provided every six (6) months. These examinations shall include all tests required in the initial examination, except that the medical history need only be updated.

The examination contents are minimum requirements. Additional tests such as lateral and oblique X-rays or pulmonary function tests may be useful. For workers exposed to three arsenicals which are associated with lymphatic cancer, copper acetoarsenite, potassium arsenite, or sodium arsenite the examination should also include palpation of superficial lymph nodes and complete blood count.

II. Noncarcinogenic Effects

The OSHA standard is based on minimizing risk of exposed workers dying of lung cancer from exposure to inorganic arsenic. It will also minimize skin cancer from such exposures.

The following three sections quoted from "Occupational Diseases: A Guide to Their Recognition", Revised Edition, June 1977, National Institute for Occupational Safety and Health is included to provide information on the nonneoplastic effects of exposure to inorganic arsenic. Such effects should not occur if the OSHA standards are followed.

A. "Local" - Trivalent arsenic compounds are corrosive to the skin. Brief contact has no effect but prolonged contact results in a local hyperemia and later vesicular or pustular eruption. The moist mucous membranes are most sensitive to the irritant action. Conjunctiva, moist and macerated areas of skin, the eyelids, the angles of the ears, nose, mouth, and respiratory mucosa are also vulnerable to the irritant effects. The wrists are common sites of dermatitis, as are the genitalia if personal hygiene is poor. Perforations of the nasal septum may occur. Arsenic trioxide and pentoxide are capable of producing skin sensitization and contact dermatitis. Arsenic is also capable of producing keratoses, especially of the palms and soles.

B. "Systemic" - The acute toxic effects of arsenic are generally seen following ingestion of inorganic arsenical compounds. This rarely occurs in an industrial setting. Symptoms develop within 1/2 to 4 hours following ingestion and are usually characterized by constriction of the throat followed by dysphagia, epigastric pain, vomiting, and watery diarrhea. Blood may appear in vomitus and stools. If the amount ingested is sufficiently high, shock may develop due to severe fluid loss, and death may ensue in 24 hours. If the acute effects are survived, exfoliative dermatitis and peripheral neuritis may develop.

Cases of acute arsenical poisoning due to inhalation are exceedingly rare in industry. When it does occur, respiratory tract symptoms - cough, chest pain, dyspnea - giddiness, headache, and extreme general weakness precede gastrointestinal symptoms. The acute toxic symptoms of trivalent arsenical poisoning are due to severe inflammation of the mucous membranes and greatly increased permeability of the blood capillaries.

Chronic arsenical poisoning due to ingestion is rare and generally confined to patients taking prescribed medications. However, it can be a concomitant of inhaled inorganic arsenic from swallowed sputum and improper eating habits. Symptoms are weight loss, nausea and diarrhea alternating with constipation, pigmentation and eruption of the skin, loss of hair, and peripheral neuritis. Chronic hepatitis and cirrhosis have been described. Polyneuritis may be the salient feature, but more frequently there are numbness and parasthenias of "glove and stocking" distribution. The skin lesions are usually melanotic and keratotic and may occasionally take the form of an intradermal cancer of the squamous cell type, but without infiltrative properties. Horizontal white lines (striations) on the fingernails and toenails are commonly seen in chronic arsenical poisoning and are considered to be a diagnostic accompaniment of arsenical polyneuritis.

Inhalation of inorganic arsenic compounds is the most common cause of chronic poisoning in the industrial situation. This condition is divided into three phases based on signs and symptoms.

First Phase: The worker complains of weakness, loss of appetite, some nausea, occasional vomiting, a sense of heaviness in the stomach, and some diarrhea.

Second Phase: The worker complains of conjunctivitis, a catarrhal state of the mucous membranes of the nose, larynx, and respiratory passage. Coryza, hoarseness, and mild tracheobronchitis may occur. Perforation of the nasal septum is common, and is probably the most typical lesion of the upper respiratory tract in occupational exposure to arsenical dust. Skin lesions, eczematoid and allergic in type, are common.

Third Phase: The worker complains of symptoms of peripheral neuritis, initially of hands and feet, which is essentially sensory. In more severe cases, motor paralyses occur; the first muscles affected are usually the toe extensors and the peronei. In only the most severe cases will paralysis of flexor muscles of the feet or of the extensor muscles of hands occur.

Liver damage from chronic arsenical poisoning is still debated, and as yet the question is unanswered. In cases of chronic and acute arsenical poisoning, toxic effects to the myocardium have been reported based on EKG changes. These findings, however, are now largely discounted and the EKG changes are ascribed to electrolyte disturbances concomitant with arsenicalism. Inhalation of arsenic trioxide and other inorganic arsenical dusts does not give rise to radiological evidence or pneumoconiosis. Arsenic does have a depressant effect upon the bone marrow, with disturbances of both erythropoiesis and myelopoiesis.

Bibliography

Dinman, B. D. 1960. Arsenic; chronic human intoxication. J. Occup. Med. 2:137.

Elkins, H. B. 1959. The Chemistry of Industrial Toxicology, 2nd ed. John Wiley and Sons, New York.

Holmquist, L. 1951. Occupational arsenical dermatitis; a study among employees at a copper-ore smelting works including investigations of skin reactions to contact with arsenic compounds. Acta. Derm. Venereol. (Supp. 26) 31:1.

Pinto, S. S., and C. M. McGill. 1953. Arsenic trioxide exposure in industry. Ind. Med. Surg. 22:281.

Pinto, S. S., and K. W. Nelson. 1976. Arsenic toxicology and industrial exposure. Annu. Rev. Pharmacol. Toxicol. 16:95.

Vallee, B. L., D. D. Ulmer, and W. E. C. Wacker. 1960. Arsenic toxicology and biochemistry. AMA Arch. Indust. Health 21:132.

III. Sputum Cytology

Sputum can be collected by aerosol inhalation during the medical exam or by spontaneous early morning cough at home. Sputum is induced by transoral inhalation of an aerosolized solution of eight per cent (8 percent) sodium chloride in water. After inhaling as few as three to five breaths the subject usually yields an adequate sputum. All sputum should be collected directly into sixty percent (60 percent) alcohol.

Scientific evidence suggests that chest X-rays and sputum cytology should be used together as screening tests for lung tests for lung cancer in high risk populations such as workers exposed to inorganic arsenic. The tests are to be performed every six months on workers who are 45 years of age or older or have worked in the regulated area for 10 or more years. Since the tests seem to be complementary, it may be advantageous to alternate the test procedures. For instance, chest X-rays could be obtained in June and December and sputum cytologies could be obtained in March and September. Facilities for providing necessary diagnostic investigation should be readily available as well as chest physicians, surgeons, radiologists, pathologists and immunotherapists to provide any necessary treatment services.

[58 FR 35597, July 1, 1993]

1915.1025 Lead

(a) "Scope and application." (1) This section applies to all occupational exposure to lead, except as provided in paragraph (a)(2).

(2) This section does not apply to the construction industry or to agricultural operations covered by 29 CFR Part 1928.

(b) "Definitions." "Action level" means employee exposure, without regard to the use of respirators, to an airborne concentration of lead of 30 micrograms per cubic meter of air (30 ug/m(3)) averaged over an 8-hour period.

"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.

"Director" means the Director, National Institute for Occupational Safety and Health (NIOSH), U.S. Department of Health, Education, and Welfare, or designee.

"Lead" means metallic lead, all inorganic lead compounds, and organic lead soaps. Excluded from this definition are all other organic lead compounds.

(c) "Permissible exposure limit (PEL)." (1) The employer shall assure that no employee is exposed to lead at concentrations greater than fifty micrograms per cubic meter of air (50 ug/m(3)) averaged over an 8-hour period.

(2) If an employee is exposed to lead for more than 8 hours in any work day, the permissible exposure limit, as a time weighted average (TWA) for that day, shall be reduced according to the following formula:

Maximum permissible limit (in ug/m(3))=400 divided by hours worked in the day.

(3) When respirators are used to supplement engineering and work practice controls to comply with the PEL and all the requirements of paragraph (f) have been met, employee exposure, for the purpose of determining whether the employer has complied with the PEL, may be considered to be at the level provided by the protection factor of the respirator for those periods the respirator is worn. Those periods may be averaged with exposure levels during periods when respirators are not worn to determine the employee's daily TWA exposure.

(d) "Exposure monitoring" - (1) "General." (i) For the purposes of paragraph (d), employee exposure is that exposure which would occur if the employee were not using a respirator.

(ii) With the exception of monitoring under paragraph (d)(3), the employer shall collect full shift (for at least 7 continuous hours) personal samples including at least one sample for each shift for each job classification in each work area.

(iii) Full shift personal samples shall be representative of the monitored employee's regular, daily exposure to lead.

(2) "Initial determination." Each employer who has a workplace or work operation covered by this standard shall determine if any employee may be exposed to lead at or above the action level.

(3) "Basis of initial determination." (i) The employer shall monitor employee exposures and shall base initial determinations on the employee exposure monitoring results and any of the following, relevant considerations:

(A) Any information, observations, or calculations which would indicate employee exposure to lead;

(B) Any previous measurements of airborne lead; and

(ii) Monitoring for the initial determination may be limited to a representative sample of the exposed employees who the employer reasonably believes are exposed to the greatest airborne concentrations of lead in the workplace.

(iii) Measurements of airborne lead made in the preceding 12 months may be used to satisfy the requirement to monitor under paragraph (d)(3)(i) if the sampling and analytical methods used meet the accuracy and confidence levels of paragraph (d)(9) of this section.

(4) "Positive initial determination and initial monitoring." (i) Where a determination conducted under paragraphs (d) (2) and (3) of this section shows the possibility of any employee exposure at or above the action level, the employer shall conduct monitoring which is representative of the exposure for each employee in the workplace who is exposed to lead.

(ii) Measurements of airborne lead made in the preceding 12 months may be used to satisfy this requirement if the sampling and analytical methods used meet the accuracy and confidence levels of paragraph (d)(9) of this section.

(5) "Negative initial determination." Where a determination, conducted under paragraphs (d) (2) and (3) of this section is made that no employee is exposed to airborne concentrations of lead at or above the action level, the employer shall make a written record of such determination. The record shall include at least the information specified in paragraph (d)(3) of this section and shall also include the date of determination, location within the worksite, and the name and social security number of each employee monitored.

(6) "Frequency." (i) If the initial monitoring reveals employee exposure to be below the action level the measurements need not be repeated except as otherwise provided in paragraph (d)(7) of this section.

(ii) If the initial determination or subsequent monitoring reveals employee exposure to be at or above the action level but below the permissible exposure limit the employer shall repeat monitoring in accordance with this paragraph at least every 6 months. The employer shall continue monitoring at the required frequency until at least two consecutive measurements, taken at least 7 days apart, are below the action level at which time the employer may discontinue monitoring for that employee except as otherwise provided in paragraph (d)(7) of this section.

(iii) If the initial monitoring reveals that employee exposure is above the permissible exposure limit the employer shall repeat monitoring quarterly. The employer shall continue monitoring at the required frequency until at least two consecutive measurements, taken at least 7 days apart, are below the PEL but at or above the action level at which time the employer shall repeat monitoring for that employee at the frequency specified in paragraph (d)(6)(ii), except as otherwise provided in paragraph (d)(7) of this section.

(7) "Additional monitoring." Whenever there has been a production, process, control or personnel change which may result in new or additional exposure to lead, or whenever the employer has any other reason to suspect a change which may result in new or additional exposures to lead, additional monitoring in accordance with this paragraph shall be conducted.

(8) "Employee notification." (i) Within 5 working days after the receipt of monitoring results, the employer shall notify each employee in writing of the results which represent that employee's exposure.

(ii) Whenever the results indicate that the representative employee exposure, without regard to respirators, exceeds the permissible exposure limit, the employer shall include in the written notice a statement that the permissible exposure limit was exceeded and a description of the corrective action taken or to be taken to reduce exposure to or below the permissible exposure limit.

(9) "Accuracy of measurement." The employer shall use a method of monitoring and analysis which has an accuracy (to a confidence level of 95 percent) of not less than plus or minus 20 percent for airborne concentrations of lead equal to or greater than 30 ug/m(3).

(e) "Methods of compliance" - (1) Engineering and work practice controls. (i) Where any employee is exposed to lead above the permissible exposure limit for more than 30 days per year, the employer shall implement engineering and work practice controls (including administrative controls) to reduce and maintain employee exposure to lead in accordance with the implementation schedule in Table I below, except to the extent that the employer can demonstrate that such controls are not feasible. Wherever the engineering and work practice controls which can be instituted are not sufficient to reduce employee exposure to or below the permissible exposure limit, the employer shall nonetheless use them to reduce exposures to the lowest feasible level and shall supplement them by the use of respiratory protection which complies with the requirements of paragraph (f) of this section.

(ii) Where any employee is exposed to lead above the permissible exposure limit, but for 30 days or less per year, the employer shall implement engineering controls to reduce exposures to 200 ug/m(3), but thereafter may implement any combination of engineering, work practice (including administrative controls), and respiratory controls to reduce and maintain employee exposure to lead to or below 50 ug/m(3)

TABLE I - IMPLEMENTATION SCHEDULE
	Compliance dates
Industry(1)	200 ug/m(3)	100 ug/m(3)	50 ug/m(3)
Primary lead production	(3)	June 29, 1984(2)	June 29, 1991(2)
Secondary lead production	(3)	June 29, 1984(2)	June 29, 1986(2)
Lead acid battery manufacture	(3)	June 29, 1983(2)	June 29, 1986(2)
Automobile manufacture/solder grinding	(3)	N/A	June 29, 1986(2)
Electronics, gray iron
foundries, ink manufacture,
paints and coatings
manufacture, wall paper
manufacture, can
manufacture, and printing	(3)	N/A	June 29, 1982(2)
Brass and bronze ingot
manufacture, lead chemical
manufacture, and secondary
copper smelting	(3)	N/A	5 years(4)
Non-ferrous foundries	(3)	N/A	5 years(4)(5)
All other industries	(3)	N/A	2 1/2 years(4)

Footnote(1) Includes ancillary activities located on the same worksite.

Footnote(2) This date is calculated by counting, from June 29, 1981 (the date when the United States Supreme court denied certiorari and lifted the stay on the implementation of paragraph (e)(1)), the number of years specified for the particular industry in the original lead standard for compliance with the given airborne exposure level. The denial of certiorari followed a decision of the United States Court of Appeals for the District of Columbia Circuit finding compliance with paragraph (e)(1) to be feasible for the relevant industries.

Footnote(3) On the effective date of this standard, March 1, 1979. This continues an obligation from Table Z-2 of 29 CFR 1910.1000, which has been in effect since 1971 but was deleted from the Code of Federal Regulations upon the effectiveness of this standard.

Footnote(4) Expressed as the number of years from the date on which the court lifts the stay on the implementation of paragraph (e)(1) for the particular industry.

Footnote(5) Large non-ferrous foundries (20 or more employees) are required to achieve 50 ug/m(3) by means of engineering and work practice controls. Small non-ferrous foundries (fewer than 20 employees), however, are only required to achieve 75 ug/m(3) by such controls. All foundries are required to comply within five years.

(2) "Respiratory protection." Where engineering and work practice controls do not reduce employee exposure to or below the 50 ug/m(3) permissible exposure limit, the employer shall supplement these controls with respirators in accordance with paragraph (f).

(3) "Compliance program." (i) Each employer shall establish and implement a written compliance program to reduce exposures to or below the permissible exposure limit, and interim levels if applicable, solely by means of engineering and work practice controls in accordance with the implementation schedule in paragraph (e)(1).

(ii) Written plans for these compliance programs shall include at least the following:

(A) A description of each operation in which lead is emitted; e.g. machinery used, material processed, controls in place, crew size, employee job responsibilities, operating procedures and maintenance practices;

(B) A description of the specific means that will be employed to achieve compliance, including engineering plans and studies used to determine methods selected for controlling exposure to lead;

(D) Air monitoring data which documents the source of lead emissions;

(E) A detailed schedule for implementation of the program, including documentation such as copies of purchase orders for equipment, construction contracts, etc.;

(F) A work practice program which includes items required under paragraphs (g), (h) and (i) of this regulation;

(G) An administrative control schedule required by paragraph (e)(6), if applicable;

(H) Other relevant information. (iii) Written programs shall be submitted upon request to the Assistant Secretary and the Director, and shall be available at the worksite for examination and copying by the Assistant Secretary, Director, any affected employee or authorized employee representatives.

(iv) Written programs shall be revised and updated at least every 6 months to reflect the current status of the program.

(4) "Bypass of interim level." Where an employer's compliance plan provides for a reduction of employee exposures to or below the PEL solely by means of engineering and work practice controls in accordance with the implementation schedule in table I, and the employer has determined that compliance with the 100 ug/m(3) interim level would divert resources to the extent that it clearly precludes compliance, otherwise attainable, with the PEL by the required time, the employer may proceed with the plan to comply with the PEL in lieu of compliance with the interim level if:

(i) The compliance plan clearly documents the basis of the determination;

(ii) The employer takes all feasible steps to provide maximum protection for employees until the PEL is met; and

(iii) The employer notifies the OSHA Area Director nearest the affected workplace in writing within 10 working days of the completion or revision of the compliance plan reflecting the determination.

(5) "Mechanical ventilation." (i) When ventilation is used to control exposure, measurements which demonstrate the effectiveness of the system in controlling exposure, such as capture velocity, duct velocity, or static pressure shall be made at least every 3 months. Measurements of the system's effectiveness in controlling exposure shall be made within 5 days of any change in production, process, or control which might result in a change in employee exposure to lead.

(ii) "Recirculation of air." If air from exhaust ventilation is recirculated into the workplace, the employer shall assure that (A) the system has a high efficiency filter with reliable back-up filter; and (B) controls to monitor the concentration of lead in the return air and to bypass the recirculation system automatically if it fails are installed, operating, and maintained.

(6) "Administrative controls." If administrative controls are used as a means of reducing employees TWA exposure to lead, the employer shall establish and implement a job rotation schedule which includes:

(i) Name or identification number of each affected employee;

(ii) Duration and exposure levels at each job or work station where each affected employee is located; and

(iii) Any other information which may be useful in assessing the reliability of administrative controls to reduce exposure to lead.

(f) "Respiratory protection" - (1) "General." Where the use of respirators is required under this section, the employer shall provide, at no cost to the employee, and assure the use of respirators which comply with the requirements of this paragraph. Respirators shall be used in the following circumstances:

(i) During the time period necessary to install or implement engineering or work practice controls, except that after the dates for compliance with the interim levels in table I, no employer shall require an employee to wear a negative pressure respirator longer than 4.4 hours per day;

(ii) In work situations in which engineering and work practice controls are not sufficient to reduce exposures to or below the permissible exposure limit; and

(iii) Whenever an employee requests a respirator.

(2) "Respirator selection." (i) Where respirators are required under this section the employer shall select the appropriate respirator or combination of respirators from table II below.

TABLE II-RESPIRATORY PROTECTION FOR LEAD AEROSOLS
Airborne concentration of lead or condition of use	Required respirator(1)
Not in excess of 0.5 mg/m(3)(10X PEL).	Half-mask, air-purifying respirator equipped with high efficiency filters.(2),(3)
Not in excess of 2.5 mg/m(3)(50X PEL).	Full facepiece, air-purifying respirator with high efficiency filters(3).
Not in excess of 50 mg/m(3)(1000X PEL).	(1) Any powered, air-purifying respirator with high efficiency filters(3); or (2) Half-mask supplied-air respirator operated in positive-pressure mode(2).
Not in excess of 100 mg/m(3)(2000X PEL).	Supplied-air respirators with full facepiece, hood, helmet, or suit, operated in positive pressure mode.
Greater than 100 mg/m(3), unknown concentration or fire fighting.	Full facepiece, self-contained breathing apparatus operated in positive-pressure mode.

Footnote(1) Respirators specified for high concentrations can be used at lower concentrations of lead.

Footnote(2) Full facepiece is required if the lead aerosols cause eye or skin irritation at the use concentrations.

Footnote(3) A high efficiency particulate filter means 99.97 percent efficient against 0.3 micron size particles.

(ii) The employer shall provide a powered, air-purifying respirator in lieu of the respirator specified in Table II whenever:

(A) An employee chooses to use this type of respirator; and

(B) This respirator will provide adequate protection to the employee. (iii) The employer shall select respirators from among those approved for protection against lead dust, fume, and mist by the Mine Safety and Health Administration and the National Institute for Occupational Safety and Health (NIOSH) under the provisions of 30 CFR Part 11.

(3) "Respirator usage." (i) The employer shall assure that the respirator issued to the employee exhibits minimum facepiece leakage and that the respirator is fitted properly.

(ii) Employers shall perform either quantitative or qualitative face fit tests at the time of initial fitting and at least every six months thereafter for each employee wearing negative pressure respirators. The qualitative fit tests may be used only for testing the fit of half-mask respirators where they are permitted to be worn, and shall be conducted in accordance with Appendix D. The tests shall be used to select facepieces that provide the required protection as prescribed in table II.

(iii) If an employee exhibits difficulty in breathing during the fitting test or during use, the employer shall make available to the employee an examination in accordance with paragraph (j)(3)(i)(C) of this section to determine whether the employee can wear a respirator while performing the required duty.

(4) "Respirator program." (i) The employer shall institute a respiratory protection program in accordance with 29 CFR 1910.134(b), (d), (e) and (f).

(iii) Employees who wear respirators shall be permitted to leave work areas to wash their face and respirator facepiece whenever necessary to prevent skin irritation associated with respirator use.

(g) "Protective work clothing and equipment" - (1) "Provision and use."

If an employee is exposed to lead above the PEL, without regard to the use of respirators or where the possibility of skin or eye irritation exists, the employer shall provide at no cost to the employee and assure that the employee uses appropriate protective work clothing and equipment such as, but not limited to:

(i) Coveralls or similar full-body work clothing;

(ii) Gloves, hats, and shoes or disposable shoe coverlets; and

(iii) Face shields, vented goggles, or other appropriate protective equipment which complies with 1910.133 of this Part.

(2) "Cleaning and replacement." (i) The employer shall provide the protective clothing required in paragraph (g)(1) of this section in a clean and dry condition at least weekly, and daily to employees whose exposure levels without regard to a respirator are over 200 ug/m(3) of lead as an 8-hour TWA.

(ii) The employer shall provide for the cleaning, laundering, or disposal of protective clothing and equipment required by paragraph (g)(1) of this section.

(iii) The employer shall repair or replace required protective clothing and equipment as needed to maintain their effectiveness.

(iv) The employer shall assure that all protective clothing is removed at the completion of a work shift only in change rooms provided for that purpose as prescribed in paragraph (i)(2) of this section.

(vi) The employer shall inform in writing any person who cleans or launders protective clothing or equipment of the potentially harmful effects of exposure to lead.

(vii) The employer shall assure that the containers of contaminated protective clothing and equipment required by paragraph (g)(2)(v) are labelled as follows:

CAUTION: CLOTHING CONTAMINATED WITH LEAD.
DO NOT REMOVE DUST BY BLOWING OR SHAKING.
DISPOSE OF LEAD CONTAMINATED WASH WATER IN ACCORDANCE
WITH APPLICABLE LOCAL, STATE, OR FEDERAL REGULATIONS.

(viii) The employer shall prohibit the removal of lead from protective clothing or equipment by blowing, shaking, or any other means which disperses lead into the air.

(h) "Housekeeping" - (1) "Surfaces." All surfaces shall be maintained as free as practicable of accumulations of lead.

(2) "Cleaning floors." (i) Floors and other surfaces where lead accumulates may not be cleaned by the use of compressed air.

(ii) Shoveling, dry or wet sweeping, and brushing may be used only where vacuuming or other equally effective methods have been tried and found not to be effective.

(3) "Vacuuming." Where vacuuming methods are selected, the vacuums shall be used and emptied in a manner which minimizes the reentry of lead into the workplace.

(i) "Hygiene facilities and practices." (1) The employer shall assure that in areas where employees are exposed to lead above the PEL, without regard to the use of respirators, food or beverage is not present or consumed, tobacco products are not present or used, and cosmetics are not applied, except in change rooms, lunchrooms, and showers required under paragraphs (i)(2) - through (i)(4) of this section.

(2) "Change rooms." (i) The employer shall provide clean change rooms for employees who work in areas where their airborne exposure to lead is above the PEL, without regard to the use of respirators.

(ii) The employer shall assure that change rooms are equipped with separate storage facilities for protective work clothing and equipment and for street clothes which prevent cross-contamination.

(3) "Showers." (i) The employer shall assure that employees who work in areas where their airborne exposure to lead is above the PEL, without regard to the use of respirators, shower at the end of the work shift.

(ii) The employer shall provide shower facilities in accordance with 1910.141(d)(3) of this part.

(iii) The employer shall assure that employees who are required to shower pursuant to paragraph (i)(3)(i) do not leave the workplace wearing any clothing or equipment worn during the work shift.

(4) "Lunchrooms." (i) The employer shall provide lunchroom facilities for employees who work in areas where their airborne exposure to lead is above the PEL, without regard to the use of respirators.

(ii) The employer shall assure that lunchroom facilities have a temperature controlled, positive pressure, filtered air supply, and are readily accessible to employees.

(iii) The employer shall assure that employees who work in areas where their airborne exposure to lead is above the PEL without regard to the use of a respirator wash their hands and face prior to eating, drinking, smoking or applying cosmetics.

(iv) The employer shall assure that employees do not enter lunchroom facilities with protective work clothing or equipment unless surface lead dust has been removed by vacuuming, downdraft booth, or other cleaning method.

(5) "Lavatories." The employer shall provide an adequate number of lavatory facilities which comply with 1910.141(d)(1) and (2) of this part.

(j) "Medical surveillance" - (1) "General." (i) The employer shall institute a medical surveillance program for all employees who are or may be exposed above the action level for more than 30 days per year.

(ii) The employer shall assure that all medical examinations and procedures are performed by or under the supervision of a licensed physician.

(iii) The employer shall provide the required medical surveillance including multiple physician review under paragraph (j)(3)(iii) without cost to employees and at a reasonable time and place.

(2) "Biological monitoring" - (i) "Blood lead and ZPP level sampling and analysis." The employer shall make available biological monitoring in the form of blood sampling and analysis for lead and zinc protoporphyrin levels to each employee covered under paragraph (j)(1)(i) of this section on the following schedule:

(A) At least every 6 months to each employee covered under paragraph (j)(1)(i) of this section;

(B) At least every two months for each employee whose last blood sampling and analysis indicated a blood lead level at or above 40 ug/100 g of whole blood. This frequency shall continue until two consecutive blood samples and analyses indicate a blood lead level below 40 ug/100 g of whole blood; and

(C) At least monthly during the removal period of each employee removed from exposure to lead due to an elevated blood lead level.

(ii) "Follow-up blood sampling tests." Whenever the results of a blood lead level test indicate that an employee's blood lead level exceeds the numerical criterion for medical removal under paragraph (k)(1)(i), the employer shall provide a second (follow-up) blood sampling test within two weeks after the employer receives the results of the first blood sampling test.

(iii) "Accuracy of blood lead level sampling and analysis." Blood lead level sampling and analysis provided pursuant to this section shall have an accuracy (to a confidence level of 95 percent) within plus or minus 15 percent or 6 ug/100 ml, whichever is greater, and shall be conducted by a laboratory licensed by the Center for Disease Control, United States Department of Health, Education and Welfare (CDC) or which has received a satisfactory grade in blood lead proficiency testing from CDC in the prior twelve months.

(iv) "Employee notification." Within five working days after the receipt of biological monitoring results, the employer shall notify in writing each employee whose blood lead level exceeds 40 ug/100 g: (A) of that employee's blood lead level and (B) that the standard requires temporary medical removal with Medical Removal Protection benefits when an employee's blood lead level exceeds the numerical criterion for medical removal under paragraph (k)(1)(i) of this section.

(3) "Medical examinations and consultations" - (i) "Frequency." The employer shall make available medical examinations and consultations to each employee covered under paragraph (j)(1)(i) of this section on the following schedule:

(A) At least annually for each employee for whom a blood sampling test conducted at any time during the preceding 12 months indicated a blood lead level at or above 40 ug/100 g;

(B) Prior to assignment for each employee being assigned for the first time to an area in which airborne concentrations of lead are at or above the action level;

(C) As soon as possible, upon notification by an employee either that the employee has developed signs or symptoms commonly associated with lead intoxication, that the employee desires medical advice concerning the effects of current or past exposure to lead on the employee's ability to procreate a healthy child, or that the employee has demonstrated difficulty in breathing during a respirator fitting test or during use; and (D) As medically appropriate for each employee either removed from exposure to lead due to a risk of sustaining material impairment to health, or otherwise limited pursuant to a final medical determination.

(ii) Content. Medical examinations made available pursuant to paragraph (j)(3)(i)(A)-(B) of this section shall include the following elements:

(A) A detailed work history and a medical history, with particular attention to past lead exposure (occupational and non-occupational), personal habits (smoking, hygiene), and past gastrointestinal, hematologic,renal, cardiovascular, reproductive and neurological problems;

(B) A thorough physical examination, with particular attention to teeth, gums, hematologic, gastrointestinal, renal, cardiovascular, and neurological systems. Pulmonary status should be evaluated if respiratory protection will be used;

(D) A blood sample and analysis which determines:

(1) Blood lead level;

(2) Hemoglobin and hematocrit determinations, red cell indices, and examination of peripheral smear morphology;

(3) Zinc protoporphyrin;

(4) Blood urea nitrogen; and,

(5) Serum creatinine;

(E) A routine urinalysis with microscopic examination; and

(F) Any laboratory or other test which the examining physician deems necessary by sound medical practice. The content of medical examinations made available pursuant to paragraph (j)(3)(i)(C) - (D) of this section shall be determined by an examining physician and, if requested by an employee, shall include pregnancy testing or laboratory evaluation of male fertility.

(iii) "Multiple physician review mechanism." (A) If the employer selects the initial physician who conducts any medical examination or consultation provided to an employee under this section, the employee may designate a second physician:

(1) To review any findings, determinations or recommendations of the initial physician; and

(2) To conduct such examinations, consultations, and laboratory tests as the second physician deems necessary to facilitate this review.

(B) The employer shall promptly notify an employee of the right to seek a second medical opinion after each occasion that an initial physician conducts a medical examination or consultation pursuant to this section. The employer may condition its participation in, and payment for, the multiple physician review mechanism upon the employee doing the following within fifteen (15) days after receipt of the foregoing notification, or receipt of the initial physician's written opinion, whichever is later:

(1) The employee informing the employer that he or she intends to seek a second medical opinion, and (2) The employee initiating steps to make an appointment with a second physician.

(C) If the findings, determinations or recommendations of the second physician differ from those of the initial physician, then the employer and the employee shall assure that efforts are made for the two physicians to resolve any disagreement.

(D) If the two physicians have been unable to quickly resolve their disagreement, then the employer and the employee through their respective physicians shall designate a third physician:

(1) To review any findings, determinations or recommendations of the prior physicians; and

(2) To conduct such examinations, consultations, laboratory tests and discussions with the prior physicians as the third physician deems necessary to resolve the disagreement of the prior physicians.

(E) The employer shall act consistent with the findings, determinations and recommendations of the third physician, unless the employer and the employee reach an agreement which is otherwise consistent with the recommendations of at least one of the three physicians.

(iv) "Information provided to examining and consulting physicians." (A) The employer shall provide an initial physician conducting a medical examination or consultation under this section with the following information:

(1) A copy of this regulation for lead including all Appendices;

(2) A description of the affected employee's duties as they relate to the employee's exposure;

(3) The employee's exposure level or anticipated exposure level to lead and to any other toxic substance (if applicable);

(4) A description of any personal protective equipment used or to be used;

(5) Prior blood lead determinations; and

(6) All prior written medical opinions concerning the employee in the employer's possession or control.

(B) The employer shall provide the foregoing information to a second or third physician conducting a medical examination or consultation under this section upon request either by the second or third physician, or by the employee.

(v) "Written medical opinions." (A) The employer shall obtain and furnish the employee with a copy of a written medical opinion from each examining or consulting physician which contains the following information:

(1) The physician's opinion as to whether the employee has any detected medical condition which would place the employee at increased risk of material impairment of the employee's health from exposure to lead;

(2) Any recommended special protective measures to be provided to the employee, or limitations to be placed upon the employee's exposure to lead;

(3) Any recommended limitation upon the employee's use of respirators, including a determination of whether the employee can wear a powered air purifying respirator if a physician determines that the employee cannot wear a negative pressure respirator; and

(4) The results of the blood lead determinations.

(B) The employer shall instruct each examining and consulting physician to:

(1) Not reveal either in the written opinion, or in any other means of communication with the employer, findings, including laboratory results, or diagnoses unrelated to an employee's occupational exposure to lead; and

(2) Advise the employee of any medical condition, occupational or nonoccupational, which dictates further medical examination or treatment.

(vi) "Alternate Physician Determination Mechanisms." The employer and an employee or authorized employee representative may agree upon the use of any expeditious alternate physician determination mechanism in lieu of the multiple physician review mechanism provided by this paragraph so long as the alternate mechanism otherwise satisfies the requirements contained in this paragraph.

(4) "Chelation." (i) The employer shall assure that any person whom he retains, employs, supervises or controls does not engage in prophylactic chelation of any employee at any time.

(ii) If therapeutic or diagnostic chelation is to be performed by any person in paragraph (j)(4)(i), the employer shall assure that it be done under the supervision of a licensed physician in a clinical setting with thorough and appropriate medical monitoring and that the employee is notified in writing prior to its occurrence.

(k) "Medical Removal Protection" - (1) "Temporary medical removal and return of an employee" - (i) "Temporary removal due to elevated blood lead levels" - (A) "First year of the standard." During the first year following the effective date of the standard, the employer shall remove an employee from work having a daily eight hour TWA exposure to lead at or above 100 ug/m(3) on each occasion that a periodic and a follow-up blood sampling test conducted pursuant to this section indicate that the employee's blood lead level is at or above 80 ug/100 g of whole blood;

(B) "Second year of the standard." During the second year following the effective date of the standard, the employer shall remove an employee from work having a daily 8-hour TWA exposure to lead at or above 50 ug/m(3) on each occasion that a periodic and a follow-up blood sampling test conducted pursuant to this section indicate that the employee's blood lead level is at or above 70 ug/100 g of whole blood;

(C) "Third year of the standard, and thereafter." Beginning with the third year following the effective date of the standard, the employer shall remove an employee from work having an exposure to lead at or above the action level on each occasion that a periodic and a follow-up blood sampling test conducted pursuant to this section indicate that the employee's blood lead level is at or above 60 ug/100 g of whole blood; and,

(D) "Fifth year of the standard, and thereafter." Beginning with the fifth year following the effective date of the standard, the employer shall remove an employee from work having an exposure to lead at or above the action level on each occasion that the average of the last three blood sampling tests conducted pursuant to this section (or the average of all blood sampling tests conducted over the previous six (6) months, whichever is longer) indicates that the employee's blood lead level is at or above 50 ug/100 g of whole blood; provided, however, that an employee need not be removed if the last blood sampling test indicates a blood lead level at or below 40 ug/100 g of whole blood.

(ii) "Temporary removal due to a final medical determination." (A) The employer shall remove an employee from work having an exposure to lead at or above the action level on each occasion that a final medical determination results in a medical finding, determination, or opinion that the employee has a detected medical condition which places the employee at increased risk of material impairment to health from exposure to lead.

(B) For the purposes of this section, the phrase "final medical determination" shall mean the outcome of the multiple physician review mechanism or alternate medical determination mechanism used pursuant to the medical surveillance provisions of this section.

(C) Where a final medical determination results in any recommended special protective measures for an employee, or limitations on an employee's exposure to lead, the employer shall implement and act consistent with the recommendation.

(iii) "Return of the employee to former job status." (A) The employer shall return an employee to his or her former job status:

(1) For an employee removed due to a blood lead level at or above 80 ug/100 g, when two consecutive blood sampling tests indicate that the employee's blood lead level is at or below 60 ug/100 g of whole blood;

(2) For an employee removed due to a blood lead level at or above 70 ug/100 g, when two consecutive blood sampling tests indicate that the employee's blood lead level is at or below 50 ug/100 g of whole blood;

(3) For an employee removed due to a blood lead level at or above 60 ug/100 g, or due to an average blood lead level at or above 50 ug/100 g, when two consecutive blood sampling tests indicate that the employee's blood lead level is at or below 40 ug/100 g of whole blood;

(4) For an employee removed due to a final medical determination, when a subsequent final medical determination results in a medical finding, determination, or opinion that the employee no longer has a detected medical condition which places the employee at increased risk of material impairment to health from exposure to lead.

(B) For the purposes of this section, the requirement that an employer return an employee to his or her former job status is not intended to expand upon or restrict any rights an employee has or would have had, absent temporary medical removal, to a specific job classification or position under the terms of a collective bargaining agreement.

(iv) "Removal of other employee special protective measure or limitations." The employer shall remove any limitations placed on an employee or end any special protective measures provided to an employee pursuant to a final medical determination when a subsequent final medical determination indicates that the limitations or special protective measures are no longer necessary.

(v) "Employer options pending a final medical determination." Where the multiple physician review mechanism, or alternate medical determination mechanism used pursuant to the medical surveillance provisions of this section, has not yet resulted in a final medical determination with respect to an employee, the employer shall act as follows:

(A) "Removal." The employer may remove the employee from exposure to lead, provide special protective measures to the employee, or place limitations upon the employee, consistent with the medical findings, determinations, or recommendations of any of the physicians who have reviewed the employee's health status.

(B) "Return." The employer may return the employee to his or her former job status, end any special protective measures provided to the employee, and remove any limitations placed upon the employee, consistent with the medical findings, determinations, or recommendations of any of the physicians who have reviewed the employee's health status, with two exceptions. If - (1) the initial removal, special protection, or limitation of the employee resulted from a final medical determination which differed from the findings, determinations, or recommendations of the initial physician or (2) The employee has been on removal status for the preceding eighteen months due to an elevated blood lead level, then the employer shall await a final medical determination.

(2) "Medical removal protection benefits" - (i) "Provision of medical removal protection benefits." The employer shall provide to an employee up to eighteen (18) months of medical removal protection benefits on each occasion that an employee is removed from exposure to lead or otherwise limited pursuant to this section.

(ii) "Definition of medical removal protection benefits." For the purposes of this section, the requirement that an employer provide medical removal protection benefits means that the employer shall maintain the earnings, seniority and other employment rights and benefits of an employee as though the employee had not been removed from normal exposure to lead or otherwise limited.

(iii) "Follow-up medical surveillance during the period of employee removal or limitation." During the period of time that an employee is removed from normal exposure to lead or otherwise limited, the employer may condition the provision of medical removal protection benefits upon the employee's participation in follow-up medical surveillance made available pursuant to this section.

(iv) "Workers' compensation claims." If a removed employee files a claim for workers' compensation payments for a lead-related disability, then the employer shall continue to provide medical removal protection benefits pending disposition of the claim. To the extent that an award is made to the employee for earnings lost during the period of removal, the employer's medical removal protection obligation shall be reduced by such amount. The employer shall receive no credit for workers' compensation payments received by the employee for treatment related expenses.

(v) "Other credits." The employer's obligation to provide medical removal protection benefits to a removed employee shall be reduced to the extent that the employee receives compensation for earnings lost during the period of removal either from a publicly or employer-funded compensation program, or receives income from employment with another employer made possible by virtue of the employee's removal.

(vi) "Employees whose blood lead levels do not adequately decline within 18 months of removal." The employer shall take the following measures with respect to any employee removed from exposure to lead due to an elevated blood lead level whose blood lead level has not declined within the past eighteen (18) months of removal so that the employee has been returned to his or her former job status:

(A) The employer shall make available to the employee a medical examination pursuant to this section to obtain a final medical determination with respect to the employee;

(B) The employer shall assure that the final medical determination obtained indicates whether or not the employee may be returned to his or her former job status, and if not, what steps should be taken to protect the employee's health;

(C) Where the final medical determination has not yet been obtained, or once obtained indicates that the employee may not yet be returned to his or her former job status, the employer shall continue to provide medical removal protection benefits to the employee until either the employee is returned to former job status, or a final medical determination is made that the employee is incapable of ever safely returning to his or her former job status.

(D) Where the employer acts pursuant to a final medical determination which permits the return of the employee to his or her former job status despite what would otherwise be an unacceptable blood lead level, later questions concerning removing the employee again shall be decided by a final medical determination. The employer need not automatically remove such an employee pursuant to the blood lead level removal criteria provided by this section.

(vii) "Voluntary Removal or Restriction of An Employee." Where an employer, although not required by this section to do so, removes an employee from exposure to lead or otherwise places limitations on an employee due to the effects of lead exposure on the employee's medical condition, the employer shall provide medical removal protection benefits to the employee equal to that required by paragraph (k)(2)(i) of this section.

(l) "Employee information and training" - (1) "Training program." (i) Each employer who has a workplace in which there is a potential exposure to airborne lead at any level shall inform employees of the content of Appendices A and B of this regulation.

(ii) The employer shall institute a training program for and assure the participation of all employees who are subject to exposure to lead at or above the action level or for whom the possibility of skin or eye irritation exists.

(iii) The employer shall provide initial training by 180 days from the effective date for those employees covered by paragraph (l)(1) (ii) on the standard's effective date and prior to the time of initial job assignment for those employees subsequently covered by this paragraph.

(iv) The training program shall be repeated at least annually for each employee.

(v) The employer shall assure that each employee is informed of the following:

(A) The content of this standard and its appendices;

(B) The specific nature of the operations which could result in exposure to lead above the action level;

(D) The purpose and a description of the medical surveillance program, and the medical removal protection program including information concerning the adverse health effects associated with excessive exposure to lead (with particular attention to the adverse reproductive effects on both males and females);

(E) The engineering controls and work practices associated with the employee's job assignment;

(F) The contents of any compliance plan in effect; and

(G) Instructions to employees that chelating agents should not routinely be used to remove lead from their bodies and should not be used at all except under the direction of a licensed physician;

(2) "Access to information and training materials." (i) The employer shall make readily available to all affected employees a copy of this standard and its appendices.

(ii) The employer shall provide, upon request, all materials relating to the employee information and training program to the Assistant Secretary and the Director.

(iii) In addition to the information required by paragraph (l)(1)(v), the employer shall include as part of the training program, and shall distribute to employees, any materials pertaining to the Occupational Safety and Health Act, the regulations issued pursuant to that Act, and this lead standard, which are made available to the employer by the Assistant Secretary.

(m) "Signs" - (1) "General." (i) The employer may use signs required by other statutes, regulations or ordinances in addition to, or in combination with, signs required by this paragraph.

(ii) The employer shall assure that no statement appears on or near any sign required by this paragraph which contradicts or detracts from the meaning of the required sign.

(2) "Signs." (i) The employer shall post the following warning signs in each work area where the PEL is exceeded:

WARNING
LEAD WORK AREA
POISON
NO SMOKING OR EATING

(ii) The employer shall assure that signs required by this paragraph are illuminated and cleaned as necessary so that the legend is readily visible.

(n) "Recordkeeping" - (1) "Exposure monitoring." (i) The employer shall establish and maintain an accurate record of all monitoring required in paragraph (d) of this section.

(ii) This record shall include:

(A) The date(s), number, duration, location and results of each of the samples taken, including a description of the sampling procedure used to determine representative employee exposure where applicable;

(B) A description of the sampling and analytical methods used and evidence of their accuracy;

(D) Name, social security number, and job classification of the employee monitored and of all other employees whose exposure the measurement is intended to represent; and

(E) The environmental variables that could affect the measurement of employee exposure.

(iii) The employer shall maintain these monitoring records for at least 40 years or for the duration of employment plus 20 years, whichever is longer.

(2) "Medical surveillance." (i) The employer shall establish and maintain an accurate record for each employee subject to medical surveillance as required by paragraph (j) of this section.

(ii) This record shall include:

(A) The name, social security number, and description of the duties of the employee;

(B) A copy of the physician's written opinions;

(C) Results of any airborne exposure monitoring done for that employee and the representative exposure levels supplied to the physician; and

(D) Any employee medical complaints related to exposure to lead.

(iii) The employer shall keep, or assure that the examining physician keeps, the following medical records:

(A) A copy of the medical examination results including medical and work history required under paragraph (j) of this section;

(B) A description of the laboratory procedures and a copy of any standards or guidelines used to interpret the test results or references to that information;

(iv) The employer shall maintain or assure that the physician maintains those medical records for at least 40 years, or for the duration of employment plus 20 years, whichever is longer.

(3) "Medical removals." (i) The employer shall establish and maintain an accurate record for each employee removed from current exposure to lead pursuant to paragraph (k) of this section.

(ii) Each record shall include:

(A) The name and social security number of the employee;

(B) The date on each occasion that the employee was removed from current exposure to lead as well as the corresponding date on which the employee was returned to his or her former job status;

(D) A statement with respect to each removal indicating whether or not the reason for the removal was an elevated blood lead level.

(iii) The employer shall maintain each medical removal record for at least the duration of an employee's employment.

(4) "Availability." (i) The employer shall make available upon request all records required to be maintained by paragraph (n) of this section to the Assistant Secretary and the Director for examination and copying.

(ii) Environmental monitoring, medical removal, and medical records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120 (a)-(e) and (2)-(i). Medical removal records shall be provided in the same manner as environmental monitoring records.

(5) "Transfer of records." (i) Whenever the employer ceases to do business, the successor employer shall receive and retain all records required to be maintained by paragraph (n) of this section.

(iv) The employer shall also comply with any additional requirements involving transfer of records set forth in 29 CFR 1915.1120(h).

(o) "Observation of monitoring." (1) "Employee observation." The employer shall provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to lead conducted pursuant to paragraph (d) of this section.

(2) "Observation procedures." (i) Whenever observation of the monitoring of employee exposure to lead requires entry into an area where the use of respirators, protective clothing or equipment is required, the employer shall provide the observer with and assure the use of such respirators, clothing and such equipment, and shall require the observer to comply with all other applicable safety and health procedures.

(ii) Without interfering with the monitoring, observers shall be entitled to:

(A) Receive an explanation of the measurement procedures;

(B) Observe all steps related to the monitoring of lead performed at the place of exposure; and

(p) "Effective date." This standard shall become effective March 1, 1979.

(q) "Appendices." The information contained in the appendices to this section is not intended by itself, to create any additional obligations not otherwise imposed by this standard nor detract from any existing obligation.

(r) "Startup dates." All obligations of this standard commence on the effective date except as follows:

(1) The initial determination under paragraph (d)(2) shall be made as soon as possible but no later than 30 days from the effective date.

(2) Initial monitoring under paragraph (d)(4) shall be completed as soon as possible but no later than 90 days from the effective date.

(3) Initial biological monitoring and medical examinations under paragraph (j) shall be completed as soon as possible but no later than 180 days from the effective date. Priority for biological monitoring and medical examinations shall be given to employees whom the employer believes to be at greatest risk from continued exposure.

(4) Initial training and education shall be completed as soon as possible but no later than 180 days from the effective date.

(5) Hygiene and lunchroom facilities under paragraph (i) shall be in operation as soon as possible but no later than 1 year from the effective year.

(6)(i) Respiratory protection required by paragraph (f) shall be provided as soon as possible but no later than the following schedule:

(A) Employees whose 8-hour TWA exposure exceeds 200 ug/m(3)-on the effective date.

(B) Employees whose 8-hour TWA exposure exceeds the PEL but is less than 200 ug/m(3)-150 days from the effective date.

(D) Quantitative fit testing required under (f)(3)(ii)-one year from effective date. Qualitative fit testing is required in the interim.

(7)(i) Written compliance plans required by paragraph (e)(3) shall be completed and available for inspection and copying as soon as possible but no later than the following schedule:

(A) Employers for whom compliance with the PEL or interim level is required within 1 year from the effective date-6 months from the effective date.

(B) Employers in secondary smelting and refining, lead storage battery manufacturing lead pigment manufacturing and nonferrous foundry industries-1 year from the effective date.

(C) Employers in primary smelting and refining industry-1 year from the effective date for the interim level; 5 years from the effective date for PEL.

(D) Plans for construction of hygiene facilities, if required-6 months from the effective date.

(8) The permissible exposure limit in paragraph (c) shall become effective 150 days from the effective date.

(Approved by the Office of Management and Budget under control number 1218-0092)

[58 FR 35598, July 1, 1993]

1915.1025 Appendix A

Substance data sheet for occupational exposure to lead.

I. "Substance Identification"

A. "Substance:" Pure lead (Pb) is a heavy metal at room temperature and pressure and is a basic chemical element. It can combine with various other substances to form numerous lead compounds.

B. "Compounds Covered by the Standard:" The word "lead" when used in this standard means elemental lead, all inorganic lead compounds and a class of organic lead compounds called lead soaps. This standard does not apply to other organic lead compounds.

C. "Uses:" Exposure to lead occurs in at least 120 different occupations, including primary and secondary lead smelting, lead storage battery manufacturing, lead pigment manufacturing and use, solder manufacturing and use, shipbuilding and ship repairing, auto manufacturing, and printing.

D. "Permissible Exposure:" The Permissible Exposure Limit (PEL) set by the standard is 50 micrograms of lead per cubic meter of air (50 ug/m(3)), averaged over an 8-hour workday.

E. "Action Level:" The standard establishes an action level of 30 micrograms per cubic meter of air (30 ug/m(3)), time weighted average, based on an 8-hour work-day. The action level initiates several requirements of the standard, such as exposure monitoring, medical surveillance, and training and education.

II. "Health Hazard Data"

A. "Ways in which lead enters your body." When absorbed into your body in certain doses lead is a toxic substance. The object of the lead standard is to prevent absorption of harmful quantities of lead. The standard is intended to protect you not only from the immediate toxic effects of lead, but also from the serious toxic effects that may not become apparent until years of exposure have passed.

Lead can be absorbed into your body by inhalation (breathing) and ingestion (eating). Lead (except for certain organic lead compounds not covered by the standard, such as tetraethyl lead) is not absorbed through your skin. When lead is scattered in the air as a dust, fume or mist it can be inhaled and absorbed through you lungs and upper respiratory tract. Inhalation of airborne lead is generally the most important source of occupational lead absorption. You can also absorb lead through your digestive system if lead gets into your mouth and is swallowed. If you handle food, cigarettes, chewing tobacco, or make-up which have lead on them or handle them with hands contaminated with lead, this will contribute to ingestion.

A significant portion of the lead that you inhale or ingest gets into your blood stream. Once in your blood stream, lead is circulated throughout your body and stored in various organs and body tissues. Some of this lead is quickly filtered out of your body and excreted, but some remains in the blood and other tissues. As exposure to lead continues, the amount stored in your body will increase if you are absorbing more lead than your body is excreting. Even though you may not be aware of any immediate symptoms of disease, this lead stored in your tissues can be slowly causing irreversible damage, first to individual cells, then to your organs and whole body systems.

B. "Effects of overexposure to lead" - (1) "Short term (acute) overexposure." Lead is a potent, systemic poison that serves no known useful function once absorbed by your body. Taken in large enough doses, lead can kill you in a matter of days. A condition affecting the brain called acute encephalopathy may arise which develops quickly to seizures, coma, and death from cardiorespiratory arrest. A short term dose of lead can lead to acute encephalopathy. Short term occupational exposures of this magnitude are highly unusual, but not impossible. Similar forms of encephalopathy may, however, arise from extended, chronic exposure to lower doses of lead. There is no sharp dividing line between rapidly developing acute effects of lead, and chronic effects which take longer to acquire. Lead adversely affects numerous body systems, and causes forms of health impairment and disease which arise after periods of exposure as short as days or as long as several years.

(2) "Long-term (chronic) overexposure." Chronic overexposure to lead may result in severe damage to your blood-forming, nervous, urinary and reproductive systems. Some common symptoms of chronic overexposure include loss of appetite, metallic taste in the mouth, anxiety, constipation, nausea, pallor, excessive tiredness, weakness, insomnia, headache, nervous irritability, muscle and joint pain or soreness, fine tremors, numbness, dizziness, hyperactivity and colic. In lead colic there may be severe abdominal pain.

Damage to the central nervous system in general and the brain (encephalopathy) in particular is one of the most severe forms of lead poisoning. The most severe, often fatal, form of encephalopathy may be preceded by vomiting, a feeling of dullness progressing to drowsiness and stupor, poor memory, restlessness, irritability, tremor, and convulsions. It may arise suddenly with the onset of seizures, followed by coma, and death. There is a tendency for muscular weakness to develop at the same time. This weakness may progress to paralysis often observed as a characteristic "wrist drop" or "foot drop" and is a manifestation of a disease to the nervous system called peripheral neuropathy.

Chronic overexposure to lead also results in kidney disease with few, if any, symptoms appearing until extensive and most likely permanent kidney damage has occurred. Routine laboratory tests reveal the presence of this kidney disease only after about two-thirds of kidney function is lost. When overt symptoms of urinary dysfunction arise, it is often too late to correct or prevent worsening conditions, and progression to kidney dialysis or death is possible.

Chronic overexposure to lead impairs the reproductive systems of both men and women. Overexposure to lead may result in decreased sex drive, impotence and sterility in men. Lead can alter the structure of sperm cells raising the risk of birth defects. There is evidence of miscarriage and stillbirth in women whose husbands were exposed to lead or who were exposed to lead themselves. Lead exposure also may result in decreased fertility, and abnormal menstrual cycles in women. The course of pregnancy may be adversely affected by exposure to lead since lead crosses the placental barrier and poses risks to developing fetuses. Children born of parents either one of whom were exposed to excess lead levels are more likely to have birth defects, mental retardation, behavioral disorders or die during the first year of childhood.

Overexposure to lead also disrupts the blood-forming system resulting in decreased hemoglobin (the substance in the blood that carries oxygen to the cells) and ultimately anemia. Anemia is characterized by weakness, pallor and fatigability as a result of decreased oxygen carrying capacity in the blood.

(3) "Health protection goals of the standard." Prevention of adverse health effects for most workers from exposure to lead throughout a working lifetime requires that worker blood lead (PbB) levels be maintained at or below forty micrograms per one hundred grams of whole blood (40 ug/100g). The blood lead levels of workers (both male and female workers) who intend to have children should be maintained below 30 ug/100g to minimize adverse reproductive health effects to the parents and to the developing fetus.

The measurement of your blood lead level is the most useful indicator of the amount of lead being absorbed by your body. Blood lead levels (PbB) are most often reported in units of milligrams (mg) or micrograms (ug) of lead (1 mg=1000 ug) per 100 grams (100g), 100 milliters (100 ml) or deciliter (dl) of blood. These three units are essentially the same. Sometime PbB's are expressed in the form of mg percent or ug percent. This is a shorthand notation for 100g, 100 ml, or dl.

PbB measurements show the amount of lead circulating in your blood stream, but do not give any information about the amount of lead stored in your various tissues. PbB measurements merely show current absorption of lead, not the effect that lead is having on your body or the effects that past lead exposure may have already caused. Past research into lead-related diseases, however, has focused heavily on associations between PbBs and various diseases. As a result, your PbB is an important indicator of the likelihood that you will gradually acquire a lead-related health impairment or disease.

Once your blood lead level climbs above 40 ug/100g, your risk of disease increases. There is a wide variability of individual response to lead, thus it is difficult to say that a particular PbB in a given person will cause a particular effect. Studies have associated fatal encephalopathy with PbBs as low as 150 ug/100g. Other studies have shown other forms of diseases in some workers with PbBs well below 80 ug/100g. Your PbB is a crucial indicator of the risks to your health, but one other factor is also extremely important. This factor is the length of time you have had elevated PbBs. The longer you have an elevated PbB, the greater the risk that large quantities of lead are being gradually stored in your organs and tissues (body burden). The greater your overall body burden, the greater the chances of substantial permanent damage.

The best way to prevent all forms of lead-related impairments and diseases-both short term and long term- is to maintain your PbB below 40 ug/100g. The provisions of the standard are designed with this end in mind. Your employer has prime responsibility to assure that the provisions of the standard are complied with both by the company and by individual workers. You as a worker, however, also have a responsibility to assist your employer in complying with the standard. You can play a key role in protecting your own health by learning about the lead hazards and their control, learning what the standard requires, following the standard where it governs your own actions, and seeing that your employer complies with provisions governing his actions.

(4) "Reporting signs and symptoms of health problems." You should immediately notify your employer if you develop signs or symptoms associated with lead poisoning or if you desire medical advice concerning the effects of current or past exposure to lead on your ability to have a healthy child. You should also notify your employer if you have difficulty breathing during a respirator fit test or while wearing a respirator. In each of these cases your employer must make available to you appropriate medical examinations or consultations. These must be provided at no cost to you and at a reasonable time and place.

The standard contains a procedure whereby you can obtain a second opinion by a physician of your choice if the employer selected the initial physician.

[58 FR 35607, July 1, 1993]

1915.1025 Appendix B Employee standard summary.

This appendix summarizes key provisions of the standard that you as a worker should become familiar with.

I. "Permissible Exposure Limit (PEL)" - "paragraph (c)"

The standards sets a permissible exposure limit (PEL) of fifty micrograms of lead per cubic meter of air (50 ug/m(3)), averaged over an 8-hour work-day. This is the highest level of lead in air to which you may be permissibly exposed over an 8-hour workday. Since it is an 8-hour average it permits short exposures above the PEL so long as for each 8-hour work day your average exposure does not exceed the PEL.

This standard recognizes that your daily exposure to lead can extend beyond a typical 8-hour workday as the result of overtime or other alterations in your work schedule. To deal with this, the standard contains a formula which reduces your permissible exposure when you are exposed more than 8 hours. For example, if you are exposed to lead for 10 hours a day, the maximum permitted average exposure would be 40 ug/m(3).

II. "Exposure Monitoring" - "paragraph (d)"

If lead is present in the workplace where you work in any quantity, your employer is required to make an initial determination of whether the action level is exceeded for any employee. This initial determination must include instrument monitoring of the air for the presence of lead and must cover the exposure of a representative number of employees who are reasonably believed to have the highest exposure levels. If your employer has conducted appropriate air sampling for lead in the past year he may use these results. If there have been any employee complaints of symptoms which may be attributable to exposure to lead or if there is any other information or observations which would indicate employee exposure to lead, this must also be considered as part of the initial determination. This initial determination must have been completed by March 31, 1979. If this initial determination shows that a reasonable possibility exists that any employee may be exposed, without regard to respirators, over the action level (30 ug/m(3)) your employer must set up an air monitoring program to determine the exposure level of every employee exposed to lead at your workplace.

In carrying out this air monitoring program, your employer is not required to monitor the exposure of every employee, but he must monitor a representative number of employees and job types. Enough sampling must be done to enable each employee's exposure level to be reasonably represented by at least one full shift (at least 7 hours) air sample. In addition, these air samples must be taken under conditions which represent each employee's regular, daily exposure to lead. All initial exposure monitoring must have been completed by May 30, 1979.

If you are exposed to lead and air sampling is performed, your employer is required to quickly notify you in writing of air monitoring results which represent your exposure. If the results indicate your exposure exceeds the PEL (without regard to your use of respirators), then your employer must also notify you of this in writing, and provide you with a description of the corrective action that will be taken to reduce your exposure.

Your exposure must be rechecked by monitoring every six months if your exposure is over the action level but below the PEL. Air monitoring must be repeated every 3 months if you are exposed over the PEL. Your employer may discontinue monitoring for you if 2 consecutive measurements, taken at least two weeks apart, are below the action level. However, whenever there is a production, process, control, or personnel change at your workplace which may result in new or additional exposure to lead, or whenever there is any other reason to suspect a change which may result in new or additional exposure to lead, your employer must perform additional monitoring.

III. "Methods of Compliance" - "paragraph (e)"

Your employer is required to assure that no employee is exposed to lead in excess of the PEL. The standard establishes a priority of methods to be used to meet the PEL.

IV. "Respiratory Protection" - "paragraph (f)"

Your employer is required to provide and assure your use of respirators when your exposure to lead is not controlled below the PEL by other means. The employer must pay the cost of the respirator. Whenever you request one, your employer is also required to provide you a respirator even if your air exposure level does not exceed the PEL. You might desire a respirator when, for example, you have received medical advice that your lead absorption should be decreased. Or, you may intend to have children in the near future, and want to reduce the level of lead in your body to minimize adverse reproductive effects. While respirators are the least satisfactory means of controlling your exposure, they are capable of providing significant protection if properly chosen, fitted, worn, cleaned, maintained, and replaced when they stop providing adequate protection.

Your employer is required to select respirators from the seven types listed in Table II of the Respiratory Protection section of the standard. Any respirator chosen must be approved by the Mine Safety and Health Administration (MSHA) or the National Institute for Occupational Safety and Health (NIOSH). This respirator selection table will enable your employer to choose a type of respirator which will give you a proper amount of protection based on your airborne lead exposure. Your employer may select a type of respirator that provides greater protection than that required by the standard; that is, one recommended for a higher concentration of lead than is present in your workplace. For example, a powered air purifying respirator (PAPR) is much more protective than a typical negative pressure respirator, and may also be more comfortable to wear. A PAPR has a filter, cartridge or canister to clean the air, and a power source which continuously blows filtered air into your breathing zone. Your employer might make a PAPR available to you to ease the burden of having to wear a respirator for long periods of time. The standard provides that you can obtain a PAPR upon request.

Your employer must also start a Respiratory Protection Program. This program must include written procedures for the proper selection, use, cleaning, storage, and maintenance of respirators.

Your employer must assure that your respirator facepiece fits properly. Proper fit of a respirator facepiece is critical. Obtaining a proper fit on each employee may require your employer to make available two or three different mask types. In order to assure that your respirator fits properly and that facepiece leakage is minimized, beginning on November 12, 1982, your employer must give you either a qualitative fit test in accordance with Appendix D of the standard or a quantitative fit test if you use a negative pressure respirator. Any respirator which has a filter, cartridge or canister which cleans the work room air before you breathe it and which requires the force of your inhalation to draw air thru the filtering element is a negative pressure respirator. A positive pressure respirator supplies air to you directly. A quantitative fit test uses a sophisticated machine to measure the amount, if any, of test material that leaks into the facepiece of your respirator.

You must also receive from your employer proper training in the use of respirators. Your employer is required to teach you how to wear a respirator, to know why it is needed, and to understand its limitations.

Until March 1, 1980, your employer must test the effectiveness of your negative pressure respirator initially and at least every six months thereafter with a "qualitative fit test." In this test, the fit of the facepiece is checked by seeing if you can smell a substance placed outside the respirator. If you can, there is appreciable leakage where the facepiece meets your face.

The standard provides that if your respirator uses filter elements, you must be given an opportunity to change the filter elements whenever an increase in breathing resistance is detected. You also must be permitted to periodically leave your work area to wash your face and respirator facepiece whenever necessary to prevent skin irritation. If you ever have difficulty in breathing during a fit test or while using a respirator, your employer must make a medical examination available to you to determine whether you can safely wear a respirator. The result of this examination may be to give you a positive pressure respirator (which reduces breathing resistance) or to provide alternative means of protection.

V. "Protective Work Clothing and Equipment" - "paragraph (g)"

If you are exposed to lead above the PEL, or if you are exposed to lead compounds such as lead arsenate or lead azide which can cause skin and eye irritation, your employer must provide you with protective work clothing and equipment appropriate for the hazard. If work clothing is provided, it must be provided in a clean and dry condition at least weekly, and daily if your airborne exposure to lead is greater than 200 ug/m(3). Appropriate protective work clothing and equipment can include coveralls or similar full-body work clothing, gloves, hats, shoes or disposable shoe coverlets, and face shields or vented goggles. Your employer is required to provide all such equipment at no cost to you. He is responsible for providing repairs and replacement as necessary, and also is responsible for the cleaning, laundering or disposal of protective clothing and equipment. Contaminated work clothing or equipment must be removed in change rooms and not worn home or you will extend your exposure and expose your family since lead from your clothing can accumulate in your house, car, etc. Contaminated clothing which is to be cleaned, laundered or disposed of must be placed in closed containers in the change room. At no time may lead be removed from protective clothing or equipment by any means which disperses lead into the workroom air.

VI. "Housekeeping" - "paragraph (h)"

Your employer must establish a housekeeping program sufficient to maintain all surfaces as free as practicable of accumulations of lead dust. Vacuuming is the preferred method of meeting this requirement, and the use of compressed air to clean floors and other surfaces is absolutely prohibited. Dry or wet sweeping, shoveling, or brushing may not be used except where vacuuming or other equally effective methods have been tried and do not work. Vacuums must be used and emptied in a manner which minimizes the reentry of lead into the workplace.

VII. "Hygiene Facilities and Practices" - "paragraph (i)"

The standard requires that change rooms, showers, and filtered air lunchrooms be constructed and made available to workers exposed to lead above the PEL. These requirements have temporarily been delayed by the court of appeals in situations where new facilities must be constructed, or where substantial renovations must be made to existing facilities. When the PEL is exceeded, the employer must assure that food and beverage is not present or consumed, tobacco products are not present or used, and cosmetics are not applied, except in these facilities. Change rooms, showers, and lunchrooms, must be used by workers exposed in excess of the PEL. After showering, no clothing or equipment worn during the shift may be worn home, and this includes shoes and underwear. Your own clothing worn during the shift should be carried home and cleaned carefully so that it does not contaminate your home. Lunchrooms may not be entered with protective clothing or equipment unless surface dust has been removed by vacuuming, downdraft booth, or other cleaning method. Finally, workers exposed above the PEL must wash both their hands and faces prior to eating, drinking, smoking or applying cosmetics.

All of the facilities and hygiene practices just discussed are essential to minimize additional sources of lead absorption from inhalation or ingestion of lead that may accumulate on you, your clothes, or your possessions. Strict compliance with these provisions can virtually eliminate several sources of lead exposure which significantly contribute to excessive lead absorption.

VIII. "Medical Surveillance" - "paragraph (j)"

The medical surveillance program is part of the standard's comprehensive approach to the prevention of lead-related disease. Its purpose is to supplement the main thrust of the standard which is aimed at minimizing airborne concentrations of lead and sources of ingestion. Only medical surveillance can determine if the other provisions of the standard have affectively protected you as an individual. Compliance with the standard's provision will protect most workers from the adverse effects of lead exposure, but may not be satisfactory to protect individual workers (1) who have high body burdens of lead acquired over past years, (2) who have additional uncontrolled sources of non-occupational lead exposure, (3) who exhibit unusual variations in lead absorption rates, or (4) who have specific non-work related medical conditions which could be aggravated by lead exposure (e.g., renal disease, anemia). In addition, control systems may fail, or hygiene and respirator programs may be inadequate. Periodic medical surveillance of individual workers will help detect those failures. Medical surveillance will also be important to protect your reproductive ability-regardless of whether you are a man or woman.

All medical surveillance required by the standard must be performed by or under the supervision of a licensed physician. The employer must provide required medical surveillance without cost to employees and at a reasonable time and place. The standard's medical surveillance program has two parts-periodic biological monitoring and medical examinations.

Your employer's obligation to offer you medical surveillance is triggered by the results of the air monitoring program. Medical surveillance must be made available to all employees who are exposed in excess of the action level for more than 30 days a year. The initial phase of the medical surveillance program, which includes blood lead level tests and medical examinations, must be completed for all covered employees no later than August 28, 1979. Priority within this first round of medical surveillance must be given to employees whom the employer believes to be at greatest risk from continued exposure (for example, those with the longest prior exposure to lead, or those with the highest current exposure). Thereafter, the employer must periodically make medical surveillance-both biological monitoring and medical examinations-available to all covered employees.

Biological monitoring under the standard consists of blood lead level (PbB) and zinc protoporphyrin tests at least every 6 months after the initial PbB test. A zinc protoporphyrin (ZPP) test is a very useful blood test which measures an effect of lead on your body. Thus biological monitoring under the standard is currently limited to PbB testing. If a worker's PbB exceeds 40 ug/100g the monitoring frequency must be increased from every 6 months to at least every 2 months and not reduced until two consecutive PbBs indicate a blood lead level below 40 ug/100g. Each time your PbB is determined to be over 40 ug/100g, your employer must notify you of this in writing within five working days of his receipt of the test results. The employer must also inform you that the standard requires temporary medical removal with economic protection when your PbB exceeds certain criteria. (See Discussion of Medical Removal Protection-Paragraph (k).) During the first year of the standard, this removal criterion is 80 ug/100g. Anytime your PbB exceeds 80 ug/100g your employer must make available to you a prompt follow-up PbB test to ascertain your PbB. If the two tests both exceed 80 ug/100g and you are temporarily removed, then your employer must make successive PbB tests available to you on a monthly basis during the period of your removal.

Medical examinations beyond the initial one must be made available on an annual basis if your blood lead level exceeds 40 ug/100g at any time during the preceding year. The initial examination will provide information to establish a baseline to which subsequent data can be compared. An initial medical examination must also be made available (prior to assignment) for each employee being assigned for the first time to an area where the airborne concentration of lead equals or exceeds the action level. In addition, a medical examination or consultation must be made available as soon as possible if you notify your employer that you are experiencing signs or symptoms commonly associated with lead poisoning or that you have difficulty breathing while wearing a respirator or during a respirator fit test. You must also be provided a medical examination or consultation if you notify your employer that you desire medical advice concerning the effects of current or past exposure to lead on your ability to procreate a healthy child.

Finally, appropriate follow-up medical examinations or consultations may also be provided for employees who have been temporarily removed from exposure under the medical removal protection provisions of the standard. (See Part IX, below.) The standard specifies the minimum content of pre-assignment and annual medical examinations. The content of other types of medical examinations and consultations is left up to the sound discretion of the examining physician. Pre-assignment and annual medical examinations must include (1) a detailed work history and medical history, (2) a thorough physical examination, and (3) a series of laboratory tests designed to check your blood chemistry and your kidney function. In addition, at any time upon your request, a laboratory evaluation of male fertility will be made (microscopic examination of a sperm sample), or a pregnancy test will be given.

The standard does not require that you participate in any of the medical procedures, tests, etc. which your employer is required to make available to you. Medical surveillance can, however, play a very important role in protecting your health. You are strongly encouraged, therefore, to participate in a meaningful fashion. The standard contains a multiple physician review mechanism which would give you a chance to have a physician of your choice directly participate in the medical surveillance program. If you were dissatisfied with an examination by a physician chosen by your employer, you could select a second physician to conduct an independent analysis. The two doctors would attempt to resolve any differences of opinion, and select a third physician to resolve any firm dispute. Generally your employer will choose the physician who conducts medical surveillance under the lead standard-unless you and your employer can agree on the choice of a physician or physicians. Some companies and unions have agreed in advance, for example, to use certain independent medical laboratories or panels of physicians. Any of these arrangements are acceptable so long as required medical surveillance is made available to workers.

The standard requires your employer to provide certain information to a physician to aid in his or her examination of you. This information includes (1) the standard and its appendices, (2) a description of your duties as they relate to lead exposure, (3) your exposure level, (4) a description of personal protective equipment you wear, (5) prior blood lead level results, and (6) prior written medical opinions concerning you that the employer has. After a medical examination or consultation the physician must prepare a written report which must contain (1) the physician's opinion as to whether you have any medical condition which places you at increased risk of material impairment to health from exposure to lead, (2) any recommended special protective measures to be provided to you, (3) any blood lead level determinations, and (4) any recommended limitation on your use of respirators. This last element must include a determination of whether you can wear a powered air purifying respirator (PAPR) if you are found unable to wear a negative pressure respirator.

The medical surveillance program of the lead standard may at some point in time serve to notify certain workers that they have acquired a disease or other adverse medical condition as a result of occupational lead exposure. If this is true, these workers might have legal rights to compensation from public agencies, their employers, firms that supply hazardous products to their employers, or other persons. Some states have laws, including worker compensation laws, that disallow a worker who learns of a job-related health impairment to sue, unless the worker sues within a short period of time after learning of the impairment. (This period of time may be a matter of months or years.) An attorney can be consulted about these possibilities. It should be stressed that OSHA is in no way trying to either encourage or discourage claims or lawsuits. However, since results of the standard's medical surveillance program can significantly affect the legal remedies of a worker who has acquired a job-related disease or impairment, it is proper for OSHA to make you aware of this.

The medical surveillance section of the standard also contains provisions dealing with chelation. Chelation is the use of certain drugs (administered in pill form or injected into the body) to reduce the amount of lead absorbed in body tissues. Experience accumulated by the medical and scientific communities has largely confirmed the effectiveness of this type of therapy for the treatment of very severe lead poisoning. On the other hand, it has also been established that there can be a long list of extremely harmful side effects associated with the use of chelating agents. The medical community has balanced the advantages and disadvantages resulting from the use of chelating agents in various circumstances and has established when the use of these agents is acceptable. The standard includes these accepted limitations due to a history of abuse of chelation therapy by some lead companies. The most widely used chelating agents are calcium disodium EDTA, (Ca Na(2) EDTA), Calcium Disodium Versenate (Versenate), and d-penicillamine (pencillamine or Cupramine).

The standard prohibits "prophylactic chelation" of any employee by any person the employer retains, supervises or controls. "Prophylactic chelation" is the routine use of chelating or similarly acting drugs to prevent elevated blood levels in workers who are occupationally exposed to lead, or the use of these drugs to routinely lower blood lead levels to predesignated concentrations believed to be `safe'. It should be emphasized that where an employer takes a worker who has no symptoms of lead poisoning and has chelation carried out by a physician (either inside or outside of a hospital) solely to reduce the worker's blood lead level, that will generally be considered prophylactic chelation. The use of a hospital and a physician does not mean that prophylactic chelation is not being performed. Routine chelation to prevent increased or reduce current blood lead levels is unacceptable whatever the setting.

The standard allows the use of "therapeutic" or "diagnostic"

chelation if administered under the supervision of a licensed physician in a clinical setting with thorough and appropriate medical monitoring. Therapeutic chelation responds to severe lead poisoning where there are marked symptoms. Diagnostic chelation involved giving a patient a dose of the drug then collecting all urine excreted for some period of time as an aid to the diagnosis of lead poisoning.

In cases where the examining physician determines that chelation is appropriate, you must be notified in writing of this fact before such treatment. This will inform you of a potentially harmful treatment, and allow you to obtain a second opinion.

IX. "Medical Removal Protection" - "paragraph (k)"

Excessive lead absorption subjects you to increased risk of disease. Medical removal protection (MRP) is a means of protecting you when, for whatever reasons, other methods, such as engineering controls, work practices, and respirators, have failed to provide the protection you need. MRP involves the temporary removal of a worker from his or her regular job to a place of significantly lower exposure without any loss of earnings, seniority, or other employment rights or benefits. The purpose of this program is to cease further lead absorption and allow your body to naturally excrete lead which has previously been absorbed. Temporary medical removal can result from an elevated blood lead level, or a medical opinion. Up to 18 months of protection is provided as a result of either form of removal. The vast majority of removed workers, however, will return to their former jobs long before this eighteen month period expires. The standard contains special provisions to deal with the extraordinary but possible case where a longterm worker's blood lead level does not adequately decline during eighteen months of removal.

During the first year of the standard, if your blood lead level is 80 ug/100g or above you must be removed from any exposure where your air lead level without a respirator would be 100 ug/m(3) or above. If you are removed from your normal job you may not be returned until your blood lead level declines to at least 60 ug/100g. These criteria for removal and return will change according to the following schedule:

	Removal blood	Air lead	Return blood lead
	lead (ug/100 g)	(ug/m(3))	(ug/100 g)

After Mar. 1, 1980	70 and above	50 and above	At or below 50
After Mar. 1, 1981	60 and above	30 and above	At or below 40
After Mar. 1, 1983	50 and above	30 and above	Do
	averaged over
	six months

You may also be removed from exposure even if your blood lead levels are below these criteria if a final medical determination indicates that you temporarily need reduced lead exposure for medical reasons. If the physician who is implementing your employers medical program makes a final written opinion recommending your removal or other special protective measures, your employer must implement the physician's recommendation. If you are removed in this manner, you may only be returned when the doctor indicates that it is safe for you to do so.

The standard does not give specific instructions dealing with what an employer must do with a removed worker. Your job assignment upon removal is a matter for you, your employer and your union (if any) to work out consistent with existing procedures for job assignments. Each removal must be accomplished in a manner consistent with existing collective bargaining relationships. Your employer is given broad discretion to implement temporary removals so long as no attempt is made to override existing agreements. Similarly, a removed worker is provided no right to veto an employer's choice which satisfies the standard.

In most cases, employers will likely transfer removed employees to other jobs with sufficiently low lead exposure. Alternatively, a worker's hours may be reduced so that the time weighted average exposure is reduced, or he or she may be temporarily laid off if no other alternative is feasible.

In all of these situation, MRP benefits must be provided during the period of removal - i.e., you continue to receive the same earnings, seniority, and other rights and benefits you would have had if you had not been removed. Earnings includes more than just your base wage; it includes overtime, shift differentials, incentives, and other compensation you would have earned if you had not been removed. During the period of removal you must also be provided with appropriate follow-up medical surveillance. If you were removed because your blood lead level was too high, you must be provided with a monthly blood test. If a medical opinion caused your removal, you must be provided medical tests or examinations that the doctor believes to be appropriate. If you do not participate in this follow up medical surveillance, you may lose your eligibility for MRP benefits.

When you are medically eligible to return to your former job, your employer must return you to your "former job status." This means that you are entitled to the position, wages, benefits, etc., you would have had if you had not been removed. If you would still be in your old job if no removal had occurred that is where you go back. If not, you are returned consistent with whatever job assignment discretion your employer would have had if no removal had occurred. MRP only seeks to maintain your rights, not expand them or diminish them.

If you are removed under MRP and you are also eligible for worker compensation or other compensation for lost wages, your employer's MRP benefits obligation is reduced by the amount that you actually receive from these other sources. This is also true if you obtain other employment during the time you are laid off with MRP benefits.

The standard also covers situations where an employer voluntarily removes a worker from exposure to lead due to the effects of lead on the employee's medical condition, even though the standard does not require removal. In these situations MRP benefits must still be provided as though the standard required removal. Finally, it is important to note that in all cases where removal is required, respirators cannot be used as a substitute. Respirators may be used before removal becomes necessary, but not as an alternative to a transfer to a low exposure job, or to a lay-off with MRP benefits.

X. "Employee Information and Training" - "paragraph (l)"

Your employer is required to provide an information and training program for all employees exposed to lead above the action level or who may suffer skin or eye irritation from lead. This program must inform these employees of the specific hazards associated with their work environment, protective measures which can be taken, the danger of lead to their bodies (including their reproductive systems), and their rights under the standard. In addition your employer must make readily available to all employees, including those exposed below the action level, a copy of the standard and its appendices and must distribute to all employees any materials provided to the employer by the Occupational Safety and Health Administration (OSHA).

Your employer is required to complete this training program for all employees by August 28, 1979. After this date, all new employees must be trained prior to initial assignment to areas where there is a possibility of exposure over the action level.

This training program must also be provided at least annually thereafter.

XI. "Signs" - "paragraph (m)"

The standard requires that the following warning sign be posted in work areas where the exposure to lead exceeds the PEL:

WARNING
LEAD WORK AREA
NO SMOKING OR EATING

XII. "Recordkeeping" - "paragraph (n)"

Your employer is required to keep all records of exposure monitoring for airborne lead. These records must include the name and job classification of employees measured, details of the sampling and analytic techniques, the results of this sampling, and the type of respiratory protection being worn by the person sampled. Your employer is also required to keep all records of biological monitoring and medical examination results. These must include the names of the employees, the physician's written opinion, and a copy of the results of the examination. All of the above kinds of records must be kept for 40 years, or for at least 20 years after your termination of employment, whichever is longer.

Recordkeeping is also required if you are temporarily removed from your job under the medical removal protection program. This record must include your name and social security number, the date of your removal and return, how the removal was or is being accomplished, and whether or not the reason for the removal was an elevated blood lead level. Your employer is required to keep each medical removal record only for as long as the duration of an employee's employment.

The standard requires that if you request to see or copy environmental monitoring, blood lead level monitoring, or medical removal records, they must be made available to you or to a representative that you authorize. Your union also has access to these records. Medical records other than PbB's must also be provided upon request to you, to your physician or to any other person whom you may specifically designate. Your union does not have access to your personal medical records unless you authorize their access.

XIII. "Observations of Monitoring" - "paragraph (o)"

When air monitoring for lead is performed at your workplace as required by this standard, your employer must allow you or someone you designate to act as an observer of the monitoring. Observers are entitled to an explanation of the measurement procedure, and to record the results obtained. Since results will not normally be available at the time of the monitoring, observers are entitled to record or receive the results of the monitoring when returned by the laboratory. Your employer is required to provide the observer with any personal protective devices required to be worn by employees working in the area that is being monitored. The employer must require the observer to wear all such equipment and to comply with all other applicable safety and health procedures.

XIV. "Effective Date" - "paragraph (p)"

The standard's effective data is March 1, 1979, and employer obligations under the standard begin to come into effect as of that date.

XV. "For Additional Information"

A. Copies of the Standard and explanatory materials can be obtained free of charge by calling or writing the OSHA Office of Publications, Room S-1212, United States Department of Labor, Washington, D.C. 20210: Telephone (202) 523-6138. The following publications are available:

1. The standard and summary of the statement of reasons (preamble), "Federal Register," Volume 43, pp. 52952-53014, November 14, 1978.

2. The full statement of reasons (preamble) "Federal Register," vol. 43, pp. 54354-54509, November 21, 1978.

3. Partial Administrative Stay and Corrections to the standard, (44 FR 5446-5448) January 26, 1979.

4. Notice of the Partial Judicial Stay (44 FR 14554-14555) March 13, 1979.

5. Corrections to the preamble, "Federal Register," vol. 44, pp. 20680-20681, April 6, 1979.

6. Additional correction to the preamble concerning the construction industry, "Federal Register," vol. 44, p. 50338, August 28, 1979.

7. Appendices to the standard (Appendices A, B, C), "Federal Register," Vol. 44, pp. 60980-60995, October 23, 1979.

8. Corrections to appendices, "Federal Register," Vol. 44, 68828, November 30, 1979.

9. Revision to the standard and additional appendices (Appendices D and E), "Federal Register," Vol. 47, pp. 51117-51119, November 12, 1982.

B. Additional information about the standard, its enforcement, and your employer's compliance can be obtained from the nearest OSHA Area Office listed in your telephone directory under United States Government/Department of Labor.

[58 FR 35608, July 1, 1993]

1915.1025 Appendix C Medical surveillance guidelines.

"Introduction"

The primary purpose of the Occupational Safety and Health Act of 1970 is to assure, so far as possible, safe and healthful working conditions for every working man and woman. The occupational health standard for inorganic lead(1) was promulgated to protect workers exposed to inorganic lead including metallic lead, all inorganic lead compounds and organic lead soaps.

_____________

Footnote(1) The term inorganic lead used throughout the medical surveillance appendices is meant to be synonymous with the definition of lead set forth in the standard.

_____________

Under this final standard in effect as of March 1, 1979, occupational exposure to inorganic lead is to be limited to 50 ug/m(3) (micrograms per cubic meter) based on an 8 hour time-weighted average (TWA). This level of exposure eventually must be achieved through a combination of engineering, work practice and other administrative controls. Periods of time ranging from 1 to 10 years are provided for different industries to implement these controls. The schedule which is based on individual industry considerations is given in Table 1. Until these controls are in place, respirators must be used to meet the 50 ug/m(3) exposure limit.

The standard also provides for a program of biological monitoring and medical surveillance for all employees exposed to levels of inorganic lead above the action level of 30 ug/m(3) (TWA) for more than 30 days per year.

The purpose of this document is to outline the medical surveillance provisions of the standard for inorganic lead, and to provide further information to the physician regarding the examination and evaluation of workers exposed to inorganic lead.

Section 1 provides a detailed description of the monitoring procedure including the required frequency of blood testing for exposed workers, provisions for medical removal protection (MRP), the recommended right of the employee to a second medical opinion, and notification and recordkeeping requirements of the employer. A discussion of the requirements for respirator use and respirator monitoring and OSHA's position on prophylactic chelation therapy are also included in this section.

Section 2 discusses the toxic effects and clinical manifestations of lead poisoning and effects of lead intoxication on enzymatic pathways in heme synthesis. The adverse effects on both male and female reproductive capacity and on the fetus are also discussed.

Section 3 outlines the recommended medical evaluation of the worker exposed to inorganic lead including details of the medical history, physical examination, and recommended laboratory tests, which are based on the toxic effects of lead as discussed in Section 2.

Section 4 provides detailed information concerning the laboratory tests available for the monitoring of exposed workers. Included also is a discussion of the relative value of each test and the limitations and precautions which are necessary in the interpretation of the laboratory results.

TABLE 1

	Effective date

Permissible airborne	Mar 1,	Mar 1,	Mar 1,	Mar 1,	Mar 1,	Mar 1,
lead levels by	1979	1980	1981	1982	1984	1989
industry (ug/m(3))(1)						(final)
1. Primary lead protection	200	200	200	100	100	50
2. Secondary lead
protection.	200	200	200	100	50	50
3. Lead-acid battery
manufacturing.	200	200	100	100	50	50
4. Nonferrous foundries.	200	100	100	100	50	50
5. Lead pigment
manufacturing.	200	200	200	100	50	50
6. All other industries	200	50	50	50	50	50

Footnote(1) Airborne levels to be achieved without reliance or respirator protection through a combination of engineering, work practice and other administrative controls. While these controls are being implemented respirators must be used to meet the 50 ug/m(3) exposure limit.

I. "Medical Surveillance and Monitoring Requirements for Workers Exposed to Inorganic Lead"

Under the occupational health standard for inorganic lead, a program of biological monitoring and medical surveillance is to be made available to all employees exposed to lead above the action level of 30 ug/m(3) TWA for more than 30 days each year. This program consists of periodic blood sampling and medical evaluation to be performed on a schedule which is defined by previous laboratory results, worker complaints or concerns, and the clinical assessment of the examining physician.

Under this program, the blood lead level of all employees who are exposed to lead above the action level of 30 ug/m(3) is to be determined at least every six months. The frequency is increased to every two months for employees whose last blood lead level was between 40 ug/100 g whole blood and the level requiring employee medical removal to be discussed below. For employees who are removed from exposure to lead due to an elevated blood lead, a new blood lead level must be measured monthly. A zinc protoporphyrin (ZPP) measurement is strongly recommended on each occasion that a blood lead level measurement is made. Last two sentences of this paragraph removed by 56 FR 24686, May 31, 1991.

An annual medical examination and consultation performed under the guidelines discussed in Section 3 is to be made available to each employee for whom a blood test conducted at any time during the preceding 12 months indicated a blood lead level at or above 40 ug/100 g. Also, an examination is to be given to all employees prior to their assignment to an area in which airborne lead concentrations reach or exceed the action level. In addition, a medical examination must be provided as soon as possible after notification by an employee that the employee has developed signs or symptoms commonly associated with lead intoxication, that the employee desires medical advice regarding lead exposure and the ability to procreate a healthy child, or that the employee has demonstrated difficulty in breathing during a respirator fitting test or during respirator use. An examination is also to be made available to each employee removed from exposure to lead due to a risk of sustaining material impairment to health, or otherwise limited or specially protected pursuant to medical recommendations.

Results of biological monitoring or the recommendations of an examining physician may necessitate removal of an employee from further lead exposure pursuant to the standard's medical removal protection (MRP) program. The object of the MRP program is to provide temporary medical removal to workers either with substantially elevated blood lead levels or otherwise at risk of sustaining material health impairment from continued substantial exposure to lead. The following guidelines which are summarized in Table 2 were created under the standard for the temporary removal of an exposed employee and his or her subsequent return to work in an exposure area.

TABLE 2
(For Table 2, see printed copy)

Under the standard's ultimate worker removal criteria, a worker is to be removed from any work having any eight hour TWA exposure to lead of 30 ug/m(3) or more whenever either of the following circumstances apply: (1) a blood lead level of 60 ug/100 g or greater is obtained and confirmed by a second follow-up blood lead level performed within two weeks after the employer receives the results of the first blood sampling test, or (2) the average of the previous three blood lead determinations or the average of all blood lead determinations conducted during the previous six months, whichever encompasses the longest time period, equals or exceeds 50 ug/100 g, unless the last blood sample indicates a blood lead level at or below 40 ug/100 g in which case the employee need not be removed. Medical removal is to continue until two consecutive blood lead levels are 40 ug/100 g or less.

During the first two years that the ultimate removal criteria are being phased in, the return criteria have been set to assure that a worker's blood lead level has substantially declined during the period of removal. From March 1, 1979 to March 1, 1980, the blood lead level requiring employee medical removal is 80 ug/100 g. Workers found to have a confirmed blood lead at this level or greater need only be removed from work having a daily 8 hour TWA exposure to lead at or above 100 ug/m(3). Workers so removed are to be returned to work when their blood lead levels are at or below 60 ug/100 g of whole blood. From March 1, 1980 to March 1, 1981, the blood lead level requiring medical removal is 70 ug/100 g. During this period workers need only be removed from jobs having a daily 8 hour TWA exposure to lead at or above 50 ug/m(3) and are to be returned to work when a level of 50 ug/100 g is achieved. Beginning March 1, 1981, return depends on a worker's blood lead level declining to 40 ug/100 g of whole blood.

As part of the standard, the employer is required to notify in writing each employee whose blood lead level exceeds 40 ug/100 g. In addition each such employee is to be informed that the standard requires medical removal with MRP benefits, discussed below, when an employee's blood lead level exceeds the above defined limits.

In addition to the above blood lead level criteria, temporary worker removal may also take place as a result of medical determinations and recommendations. Written medical opinions must be prepared after each examination pursuant to the standard. If the examining physician includes a medical finding, determination or opinion that the employee has a medical condition which places the employee at increased risk of material health impairment from exposure to lead, then the employee must be removed from exposure to lead at or above the action level. Alternatively, if the examining physician recommends special protective measures for an employee (e.g., use of a powered air purifying respirator) or recommends limitations on an employee's exposure to lead, then the employer must implement these recommendations. Recommendations may be more stringent than the specific provisions of the standard. The examining physician, therefore, is given broad flexibility to tailor special protective procedures to the needs of individual employees. This flexibility extends to the evaluation and management of pregnant workers and male and female workers who are planning to raise children. Based on the history, physical examination, and laboratory studies, the physician might recommend special protective measures or medical removal for an employee who is pregnant or who is planning to conceive a child when, in the physician's judgment, continued exposure to lead at the current job would pose a significant risk. The return of the employee to his or her former job status, or the removal of special protections or limitations, depends upon the examining physician determining that the employee is no longer at increased risk of material impairment or that special measures are no longer needed.

During the period of any form of special protection or removal, the employer must maintain the worker's earnings, seniority, and other employment rights and benefits (as though the worker had not been removed) for a period of up to 18 months. This economic protection will maximize meaningful worker participation in the medical surveillance program, and is appropriate as part of the employer's overall obligation to provide a safe and healthful workplace. The provisions of MRP benefits during the employee's removal period may, however, be conditioned upon participation in medical surveillance.

On rare occasions, an employee's blood lead level may not acceptably decline within 18 months of removal. This situation will arise only in unusual circumstances, thus the standard relies on an individual medical examination to determine how to protect such an employee. This medical determination is to be based on both laboratory values, including lead levels, zinc protoporphyrin levels, blood counts, and other tests felt to be warranted, as well as the physician's judgment that any symptoms or findings on physical examination are a result of lead toxicity. The medical determination may be that the employee is incapable of ever safely returning to his or her former job status. The medical determination may provide additional removal time past 18 months for some employees or specify special protective measures to be implemented.

The lead standard provides for a multiple physician review in cases where the employee wishes a second opinion concerning potential lead poisoning or toxicity. If an employee wishes a second opinion, he or she can make an appointment with a physician of his or her choice. This second physician will review the findings, recommendations or determinations of the first physician and conduct any examinations, consultations or tests deemed necessary in an attempt to make a final medical determination. If the first and second physicians do not agree in their assessment they must try to resolve their differences. If they cannot reach an agreement then they must designate a third physician to resolve the dispute.

The employer must provide examining and consulting physicians with the following specific information: a copy of the lead regulations and all appendices, a description of the employee's duties as related to exposure, the exposure level to lead and any other toxic substances (if applicable), a description of personal protective equipment used, blood lead levels, and all prior written medical opinions regarding the employee in the employer's possession or control. The employer must also obtain from the physician and provide the employee with a written medical opinion containing blood lead levels, the physicians's opinion as to whether the employee is at risk of material impairment to health, any recommended protective measures for the employee if further exposure is permitted, as well as any recommended limitations upon an employee's use of respirators.

Employers must instruct each physician not to reveal to the employer in writing or in any other way his or her findings, laboratory results, or diagnoses which are felt to be unrelated to occupational lead exposure. They must also instruct each physician to advise the employee of any occupationally or non-occupationally related medical condition requiring further treatment or evaluation.

The standard provides for the use of respirators where engineering and other primary controls have not been fully implemented. However, the use of respirator protection shall not be used in lieu of temporary medical removal due to elevated blood lead levels or findings that an employee is at risk of material health impairment. This is based on the numerous inadequacies of respirators including skin rash where the facepiece makes contact with the skin, unacceptable stress to breathing in some workers with underlying cardiopulmonary impairment, difficulty in providing adequate fit, the tendency for respirators to create additional hazards by interfering with vision, hearing, and mobility, and the difficulties of assuring the maximum effectiveness of a complicated work practice program involving respirators. Respirators do, however, serve a useful function where engineering and work practice controls are inadequate by providing supplementary, interim, or short-term protection, provided they are properly selected for the environment in which the employee will be working, properly fitted to the employee, maintained and cleaned periodically, and worn by the employee when required.

In its final standard on occupational exposure to inorganic lead, OSHA has prohibited prophylactic chelation. Diagnostic and therapeutic chelation are permitted only under the supervision of a licensed physician with appropriate medical monitoring in an acceptable clinical setting. The decision to initiate chelation therapy must be made on an individual basis and take into account the severity of symptoms felt to be a result of lead toxicity along with blood lead levels, ZPP levels, and other laboratory tests as appropriate. EDTA and penicillamine which are the primary chelating agents used in the therapy of occupational lead poisoning have significant potential side effects and their use must be justified on the basis of expected benefits to the worker. Unless frank and severe symptoms are present, therapeutic chelation is not recommended given the opportunity to remove a worker from exposure and allow the body to naturally excrete accumulated lead. As a diagnostic aid, the chelation mobilization test using CA-EDTA has limited applicability. According to some investigators, the test can differentiate between lead-induced and other nephropathies. The test may also provide an estimation of the mobile fraction of the total body lead burden.

Employers are required to assure that accurate records are maintained on exposure monitoring, medical surveillance, and medical removal for each employee. Exposure monitoring and medical surveillance records must be kept for 40 years or the duration of employment plus 20 years, whichever is longer, while medical removal records must be maintained for the duration of employment. All records required under the standard must be made available upon request to the Assistant Secretary of Labor for Occupational Safety and Health and the Director of the National Institute for Occupational Safety and Health. Employers must also make environmental and biological monitoring and medical removal records available to affected employees and to former employees or their authorized employee representatives. Employees or their specifically designated representatives have access to their entire medical surveillance records.

In addition, the standard requires that the employer inform all workers exposed to lead at or above the action level of the provisions of the standard and all its appendices, the purpose and description of medical surveillance and provisions for medical removal protection if temporary removal is required. An understanding of the potential health effects of lead exposure by all exposed employees along with full understanding of their rights under the lead standard is essential for an effective monitoring program.

II. "Adverse Health Effects of Inorganic Lead"

Although the toxicity of lead has been known for 2,000 years, the knowledge of the complex relationship between lead exposure and human response is still being refined. Significant research into the toxic properties of lead continues throughout the world, and it should be anticipated that our understanding of thresholds of effects and margins of safety will be improved in future years. The provisions of the lead standard are founded on two prime medical judgments: first, the prevention of adverse health effects from exposure to lead throughout a working lifetime requires that worker blood lead levels be maintained at or below 40 g/100 g and second, the blood lead levels of workers, male or female, who intend to parent in the near future should be maintained below 30 ug/100 g to minimize adverse reproductive health effects to the parents and developing fetus. The adverse effects of lead on reproduction are being actively researched and OSHA encourages the physician to remain abreast of recent developments in the area to best advise pregnant workers or workers planning to conceive children.

The spectrum of health effects caused by lead exposure can be subdivided into five developmental stages: normal, physiological changes of uncertain significance, pathophysiological changes, overt symptoms (morbidity), and mortality. Within this process there are no sharp distinctions, but rather a continuum of effects. Boundaries between categories overlap due to the wide variation of individual responses and exposures in the working population. OSHA's development of the lead standard focused on pathophysiological changes as well as later stages of disease.

1. "Heme Synthesis Inhibition." The earliest demonstrated effect of lead involves its ability to inhibit at least two enzymes of the heme synthesis pathway at very low blood levels. Inhibition of delta aminolevulinic acid dehydrase (ALA-D) which catalyzes the conversion of delta-aminolevulinic acid (ALA) to protoporphyrin is observed at a blood lead level below 20 ug/100 g whole blood. At a blood lead level of 40 ug/100 g, more than 20 percent of the population would have 70 percent inhibition of ALA-D. There is an exponential increase in ALA excretion at blood lead levels greater than 40 ug/100 g.

Another enzyme, ferrochelatase, is also inhibited at low blood lead levels. Inhibition of ferrochelatase leads to increased free erythrocyte protoporphyrin (FEP) in the blood which can then bind to zinc to yield zinc protoporphyrin. At a blood lead level of 50 ug/100 g or greater, nearly 100 percent of the population will have an increase in FEP. There is also an exponential relationship between blood lead levels greater than 40 ug/100 g and the associated ZPP level, which has led to the development of the ZPP screening test for lead exposure.

While the significance of these effects is subject to debate, it is OSHA's position that these enzyme disturbances are early stages of a disease process which may eventually result in the clinical symptoms of lead poisoning. Whether or not the effects do progress to the later stages of clinical disease, disruption of these enzyme processes over a working lifetime is considered to be a material impairment of health.

One of the eventual results of lead-induced inhibition of enzymes in the heme synthesis pathway is anemia which can be asymptomatic if mild but associated with a wide array of symptoms including dizziness, fatigue, and tachycardia when more severe. Studies have indicated that lead levels as low as 50 ug/100 g can be associated with a definite decreased hemoglobin, although most cases of lead-induced anemia, as well as shortened red-cell survival times, occur at lead levels exceeding 80 ug/100 g. Inhibited hemoglobin synthesis is more common in chronic cases whereas shortened erythrocyte life span is more common in acute cases.

In lead-induced anemias, there is usually a reticulocytosis along with the presence of basophilic stippling, and ringed sideroblasts, although none of the above are pathognomonic for lead-induced anemia.

2. "Neurological Effects." Inorganic lead has been found to have toxic effects on both the central and peripheral nervous systems. The earliest stages of lead-induced central nervous system effects first manifest themselves in the form of behavioral disturbances and central nervous system symptoms including irritability, restlessness, insomnia and other sleep disturbances, fatigue, vertigo, headache, poor memory, tremor, depression, and apathy. With more severe exposure, symptoms can progress to drowsiness, stupor, hallucinations, delirium, convulsions and coma.

The most severe and acute form of lead poisoning which usually follows ingestion or inhalation of large amounts of lead is acute encephalopathy which may arise precipitously with the onset of intractable seizures, coma, cardiorespiratory arrest, and death within 48 hours.

While there is disagreement about what exposure levels are needed to produce the earliest symptoms, most experts agree that symptoms definitely can occur at blood lead levels of 60 ug/100 g whole blood and therefore recommend a 40 ug/100 g maximum. The central nervous system effects frequently are not reversible following discontinued exposure or chelation therapy and when improvement does occur, it is almost always only partial.

The peripheral neuropathy resulting from lead exposure characteristically involves only motor function with minimal sensory damage and has a marked predilection for the extensor muscles of the most active extremity. The peripheral neuropathy can occur with varying degrees of severity. The earliest and mildest form which can be detected in workers with blood lead levels as low as 50 ug/100 g is manifested by slowing of motor nerve conduction velocity often without clinical symptoms. With progression of the neuropathy there is development of painless extensor muscle weakness usually involving the extensor muscles of the fingers and hand in the most active upper extremity, followed in severe cases by wrist drop or, much less commonly, foot drop.

In addition to slowing of nerve conduction, electromyographical studies in patients with blood lead levels greater than 50 ug/100 g have demonstrated a decrease in the number of acting motor unit potentials, an increase in the duration of motor unit potentials, and spontaneous pathological activity including fibrillations and fasciculations. Whether these effects occur at levels of 40 ug/100 g is undetermined.

While the peripheral neuropathies can occasionally be reversed with therapy, again such recovery is not assured particularly in the more severe neuropathies and often improvement is only partial. The lack of reversibility is felt to be due in part to segmental demyelination.

3. "Gastrointestinal." Lead may also affect the gastrointestinal system producing abdominal colic or diffuse abdominal pain, constipation, obstipation, diarrhea, anorexia, nausea and vomiting. Lead colic rarely develops at blood lead levels below 80 ug/100 g.

4. "Renal." Renal toxicity represents one of the most serious health effects of lead poisoning. In the early stages of disease nuclear inclusion bodies can frequently be identified in proximal renal tubular cells. Renal function remains normal and the changes in this stage are probably reversible. With more advanced disease there is progressive interstitial fibrosis and impaired renal function. Eventually extensive interstitial fibrosis ensues with sclerotic glomeruli and dilated and atrophied proximal tubules; all represent end stage kidney disease. Azotemia can be progressive, eventually resulting in frank uremia necessitating dialysis. There is occasionally associated hypertension and hyperuricemia with or without gout.

Early kidney disease is difficult to detect. The urinalysis is normal in early lead nephropathy and the blood urea nitrogen and serum creatinine increase only when two-thirds of kidney function is lost. Measurement of creatinine clearance can often detect earlier disease as can other methods of measurement of glomerular filtration rate. An abnormal Ca-EDTA mobilization test has been used to differentiate between lead-induced and other nephropathies, but this procedure is not widely accepted. A form of Fanconi syndrome with aminoaciduria, glycosuria, and hyperphosphaturia indicating severe injury to the proximal renal tubules is occasionally seen in children.

5. "Reproductive effects." Exposure to lead can have serious effects on reproductive function in both males and females. In male workers exposed to lead there can be a decrease in sexual drive, impotence, decreased ability to produce healthy sperm, and sterility. Malformed sperm (teratospermia), decreased number of sperm (hypospermia), and sperm with decreased motility (asthenospermia) can all occur. Teratospermia has been noted at mean blood lead levels of 53 ug/100 g and hypospermia and asthenospermia at 41 ug/100 g. Furthermore, there appears to be a dose-response relationship for teratospermia in lead exposed workers.

Women exposed to lead may experience menstrual disturbances including dysmenorrhea, menorrhagia and amenorrhea. Following exposure to lead, women have a higher frequency of sterility, premature births, spontaneous miscarriages, and stillbirths.

Germ cells can be affected by lead and cause genetic damage in the egg or sperm cells before conception and result in failure to implant, miscarriage, stillbirth, or birth defects.

Infants of mothers with lead poisoning have a higher mortality during the first year and suffer from lowered birth weights, slower growth, and nervous system disorders.

Lead can pass through the placental barrier and lead levels in the mother's blood are comparable to concentrations of lead in the umbilical cord at birth. Transplacental passage becomes detectable at 12-14 weeks of gestation and increases until birth.

There is little direct data on damage to the fetus from exposure to lead but it is generally assumed that the fetus and newborn would be at least as susceptible to neurological damage as young children. Blood lead levels of 50-60 ug/100 g in children can cause significant neurobehavioral impairments and there is evidence of hyperactivity at blood levels as low as 25 ug/100 g. Given the overall body of literature concerning the adverse health effects of lead in children, OSHA feels that the blood lead level in children should be maintained below 30 ug/100 g with a population mean of 15 ug/100 g. Blood lead levels in the fetus and newborn likewise should not exceed 30 ug/100 g.

Because of lead's ability to pass through the placental barrier and also because of the demonstrated adverse effects of lead on reproductive function in both the male and female as well as the risk of genetic damage of lead on both the ovum and sperm, OSHA recommends a 30 ug/100 g maximum permissible blood lead level in both males and females who wish to bear children.

6. "Other toxic effects." Debate and research continue on the effects of lead on the human body. Hypertension has frequently been noted in occupationally exposed individuals although it is difficult to assess whether this is due to lead's adverse effects on the kidney or if some other mechanism is involved. Vascular and electrocardiographic changes have been detected but have not been well characterized. Lead is thought to impair thyroid function and interfere with the pituitary-adrenal axis, but again these effects have not been well defined.

III. "Medical Evaluation"

The most important principle in evaluating a worker for any occupational disease including lead poisoning is a high index of suspicion on the part of the examining physician. As discussed in Section 2, lead can affect numerous organ systems and produce a wide array of signs and symptoms, most of which are non-specific and subtle in nature at least in the early stages of disease. Unless serious concern for lead toxicity is present, many of the early clues to diagnosis may easily be overlooked.

The crucial initial step in the medical evaluation is recognizing that a worker's employment can result in exposure to lead. The worker will frequently be able to define exposures to lead and lead containing materials but often will not volunteer this information unless specifically asked. In other situations the worker may not know of any exposures to lead but the suspicion might be raised on the part of the physician because of the industry or occupation of the worker. Potential occupational exposure to lead and its compounds occur in at least 120 occupations, including lead smelting, the manufacture of lead storage batteries, the manufacture of lead pigments and products containing pigments, solder manufacture, shipbuilding and ship repair, auto manufacturing, construction, and painting.

Once the possibility for lead exposure is raised, the focus can then be directed toward eliciting information from the medical history, physical exam, and finally from laboratory data to evaluate the worker for potential lead toxicity.

A complete and detailed work history is important in the initial evaluation. A listing of all previous employment with information on work processes, exposure to fumes or dust, known exposures to lead or other toxic substances, respiratory protection used, and previous medical surveillance should all be included in the worker's record. Where exposure to lead is suspected, information concerning on-the-job personal hygiene, smoking or eating habits in work areas, laundry procedures, and use of any protective clothing or respiratory protection equipment should be noted. A complete work history is essential in the medical evaluation of a worker with suspected lead toxicity, especially when long term effects such as neurotoxicity and nephrotoxicity are considered.

The medical history is also of fundamental importance and should include a listing of all past and current medical conditions, current medications including proprietary drug intake, previous surgeries and hospitalizations, allergies, smoking history, alcohol consumption, and also non-occupational lead exposures such as hobbies (hunting, riflery). Also known childhood exposures should be elicited. Any previous history of hematological, neurological, gastrointestinal, renal, psychological, gynecological, genetic, or reproductive problems should be specifically noted.

A careful and complete review of systems must be performed to assess both recognized complaints and subtle or slowly acquired symptoms which the worker might not appreciate as being significant. The review of symptoms should include the following:

General-weight loss, fatigue, decreased appetite. Head, Eyes, Ears, Nose, Throat (HEENT)-headaches, visual disturbances or decreased visual acuity, hearing deficits or tinnitus, pigmentation of the oral mucosa, or metallic taste in mouth.

Cardio-pulmonary-shortness of breath, cough, chest pains, palpitations, or orthopnea.

Gastrointestinal-nausea, vomiting, heartburn, abdominal pain, constipation or diarrhea.

Neurologic-irritability, insomnia, weakness (fatigue), dizziness, loss of memory, confusion, hallucinations, incoordination, ataxia, decreased strength in hands or feet, disturbances in gait, difficulty in climbing stairs, or seizures.

Hematologic-pallor, easy fatigability, abnormal blood loss, melena. Reproductive (male and female and spouse where relevant)-history of infertility, impotence, loss of libido, abnormal menstrual periods, history of miscarriages, stillbirths, or children with birth defects.

Musculo-skeletal-muscle and joint pains. The physical examination should emphasize the neurological, gastrointestinal, and cardiovascular systems. The worker's weight and blood pressure should be recorded and the oral mucosa checked for pigmentation characteristic of a possible Burtonian or lead line on the gingiva. It should be noted, however, that the lead line may not be present even in severe lead poisoning if good oral hygiene is practiced.

The presence of pallor on skin examination may indicate an anemia, which if severe might also be associated with a tachycardia. If an anemia is suspected, an active search for blood loss should be undertaken including potential blood loss through the gastrointestinal tract.

A complete neurological examination should include an adequate mental status evaluation including a search for behavioral and psychological disturbances, memory testing, evaluation for irritability, insomnia, hallucinations, and mental clouding. Gait and coordination should be examined along with close observation for tremor. A detailed evaluation of peripheral nerve function including careful sensory and motor function testing is warranted. Strength testing particularly of extensor muscle groups of all extremities is of fundamental importance.

Cranial nerve evaluation should also be included in the routine examination.

The abdominal examination should include auscultation for bowel sounds and abdominal bruits and palpation for organomegaly, masses, and diffuse abdominal tenderness.

Cardiovascular examination should evaluate possible early signs of congestive heart failure. Pulmonary status should be addressed particularly if respirator protection is contemplated.

As part of the medical evaluation, the lead standard requires the following laboratory studies:

1. Blood lead level 2. Hemoglobin and hematocrit determinations, red cell indices, and examination of the peripheral blood smear to evaluate red blood cell morphology 3. Blood urea nitrogen 4. Serum creatinine 5. Routine urinalysis with microscopic examination. 6. A zinc protoporphyrin level. In addition to the above, the physician is authorized to order any further laboratory or other tests which he or she deems necessary in accordance with sound medical practice. The evaluation must also include pregnancy testing or laboratory evaluation of male fertility if requested by the employee.

Additional tests which are probably not warranted on a routine basis but may be appropriate when blood lead and ZPP levels are equivocal include delta aminolevulinic acid and coproporphyrin concentrations in the urine, and dark-field illumination for detection of basophilic stippling in red blood cells.

If an anemia is detected further studies including a careful examination of the peripheral smear, reticulocyte count, stool for occult blood, serum iron, total iron binding capacity, bilirubin, and, if appropriate, vitamin B12 and folate may be of value in attempting to identify the cause of the anemia.

If a peripheral neuropathy is suspected, nerve conduction studies are warranted both for diagnosis and as a basis to monitor any therapy.

If renal disease is questioned, a 24 hour urine collection for creatinine clearance, protein, and electrolytes may be indicated. Elevated uric acid levels may result from lead-induced renal disease and a serum uric acid level might be performed.

An electrocardiogram and chest x-ray may be obtained as deemed appropriate.

Sophisticated and highly specialized testing should not be done routinely and where indicated should be under the direction of a specialist.

IV. "Laboratory Evaluation"

The blood lead level at present remains the single most important test to monitor lead exposure and is the test used in the medical surveillance program under the lead standard to guide employee medical removal. The ZPP has several advantages over the blood lead level. Because of its relatively recent development and the lack of extensive data concerning its interpretation, the ZPP currently remains an ancillary test.

This section will discuss the blood lead level and ZPP in detail and will outline their relative advantages and disadvantages. Other blood tests currently available to evaluate lead exposure will also be reviewed.

The blood lead level is a good index of current or recent lead absorption when there is no anemia present and when the worker has not taken any chelating agents. However, blood lead levels along with urinary lead levels do not necessarily indicate the total body burden of lead and are not adequate measures of past exposure. One reason for this is that lead has a high affinity for bone and up to 90 percent of the body's total lead is deposited there. A very important component of the total lead body burden is lead in soft tissue (liver, kidney, and brain). This fraction of the lead body burden, the biologically active lead, is not entirely reflected by blood lead levels since it is a function of the dynamics of lead absorption, distribution, deposition in bone and excretion. Following discontinuation of exposure to lead, the excess body burden is only slowly mobilized from bone and other relatively stable body stores and excreted. Consequently, a high blood lead level may only represent recent heavy exposure to lead without a significant total body excess and likewise a low blood lead level does not exclude an elevated total body burden of lead.

Also due to its correlation with recent exposures, the blood lead level may vary considerably over short time intervals.

To minimize laboratory error and erroneous results due to contamination, blood specimens must be carefully collected after thorough cleaning of the skin with appropriate methods using lead-free blood containers and analyzed by a reliable laboratory. Under the standard, samples must be analyzed in laboratories which are approved by the Center for Disease Control (CDC) or which have received satisfactory grades in proficiency testing by the CDC in the previous year. Analysis is to be made using atomic absorption spectrophotometry, anodic stripping voltammetry or any method which meets the accuracy requirements set forth by the standard.

The determination of lead in urine is generally considered a less reliable monitoring technique than analysis of whole blood primarily due to individual variability in urinary excretion capacity as well as the technical difficulty of obtaining accurate 24 hour urine collections. In addition, workers with renal insufficiency, whether due to lead or some other cause, may have decreased lead clearance and consequently urine lead levels may underestimate the true lead burden. Therefore, urine lead levels should not be used as a routine test.

The zinc protoporphyrin test, unlike the blood lead determination, measures an adverse metabolic effect of lead and as such is a better indicator of lead toxicity than the level of blood lead itself. The level of ZPP reflects lead absorption over the preceding 3 to 4 months, and therefore is a better indicator of lead body burden. The ZPP requires more time than the blood lead to read significantly elevated levels; the return to normal after discontinuing lead exposure is also slower. Furthermore, the ZPP test is simpler, faster, and less expensive to perform and no contamination is possible. Many investigators believe it is the most reliable means of monitoring chronic lead absorption.

Zinc protoporphyrin results from the inhibition of the enzyme ferrochelatase which catalyzes the insertion of an iron molecule into the protoporphyrin molecule, which then becomes heme. If iron is not inserted into the molecule then zinc, having a greater affinity for protoporphyrin, takes the place of the iron, forming ZPP.

An elevation in the level of circulating ZPP may occur at blood lead levels as low as 20-30 ug/100 g in some workers. Once the blood lead level has reached 40 ug/100 g there is more marked rise in the ZPP value from its normal range of less than 100 ug/100 ml. Increases in blood lead levels beyond 40 ug/100 g are associated with exponential increases in ZPP.

Whereas blood lead levels fluctuate over short time spans, ZPP levels remain relatively stable. ZPP is measured directly in red blood cells and is present for the cell's entire 120 day life-span. Therefore, the ZPP level in blood reflects the average ZPP production over the previous 3-4 months and consequently the average lead exposure during that time interval.

It is recommended that a hematocrit be determined whenever a confirmed ZPP of 50 ug/100 ml whole blood is obtained to rule out a significant underlying anemia. If the ZPP is in excess of 100 ug/100 ml and not associated with abnormal elevations in blood lead levels, the laboratory should be checked to be sure that blood leads were determined using atomic absorption spectrophotometry anodic stripping voltammetry, or any method which meets the accuracy requirements set forth by the standard by a CDC approved laboratory which is experienced in lead level determinations. Repeat periodic blood lead studies should be obtained in all individuals with elevated ZPP levels to be certain that an associated elevated blood lead level has not been missed due to transient fluctuations in blood leads.

ZPP has a characteristic fluorescence spectrum with a peak at 594 nm which is detectable with a hematofluorimeter. The hematofluorimeter is accurate and portable and can provide on-site, instantaneous results for workers who can be frequently tested via a finger prick.

However, careful attention must be given to calibration and quality control procedures. Limited data on blood lead-ZPP correlations and the ZPP levels which are associated with the adverse health effects discussed in Section 2 are the major limitations of the test. Also it is difficult to correlate ZPP levels with environmental exposure and there is some variation of response with age and sex. Nevertheless, the ZPP promises to be an important diagnostic test for the early detection of lead toxicity and its value will increase as more data is collected regarding its relationship to other manifestations of lead poisoning.

Levels of delta-aminolevulinic acid (ALA) in the urine are also used as a measure of lead exposure. Increasing concentrations of ALA are believed to result from the inhibition of the enzyme delta-aminolevulinic acid dehydrase (ALA-D). Although the test is relatively easy to perform, inexpensive, and rapid, the disadvantages include variability in results, the necessity to collect a complete 24 hour urine sample which has a specific gravity greater than 1.010, and also the fact that ALA decomposes in the presence of light.

The pattern of porphyrin excretion in the urine can also be helpful in identifying lead intoxication. With lead poisoning, the urine concentrations of coproporphyrins I and II, porphobilinogen and uroporphyrin I rise. The most important increase, however, is that of coproporphyrin III; levels may exceed 5,000 ug/1 in the urine in lead poisoned individuals, but its correlation with blood lead levels and ZPP are not as good as those of ALA. Increases in urinary porphyrins are not diagnostic of lead toxicity and may be seen in porphyria, some liver diseases, and in patients with high reticulocyte counts.

"Summary." The Occupational Safety and Health Administration's standard for inorganic lead places significant emphasis on the medical surveillance of all workers exposed to levels of inorganic lead above the action level of 30 ug/m(3) TWA. The physician has a fundamental role in this surveillance program, and in the operation of the medical removal protection program.

Even with adequate worker education on the adverse health effects of lead and appropriate training in work practices, personal hygiene and other control measures, the physician has a primary responsibility for evaluating potential lead toxicity in the worker. It is only through a careful and detailed medical and work history, a complete physical examination and appropriate laboratory testing that an accurate assessment can be made. Many of the adverse health effects of lead toxicity are either irreversible or only partially reversible and therefore early detection of disease is very important.

This document outlines the medical monitoring program as defined by the occupational safety and health standard for inorganic lead. It reviews the adverse health effects of lead poisoning and describes the important elements of the history and physical examinations as they relate to these adverse effects. Finally, the appropriate laboratory testing for evaluating lead exposure and toxicity is presented.

It is hoped that this review and discussion will give the physician a better understanding of the OSHA standard with the ultimate goal of protecting the health and well-being of the worker exposed to lead under his or her care.

[58 FR 35612, July 1, 1993]

1915.1025 Appendix D Qualitative fit test protocols.

This appendix specifies the only allowable qualitative fit test protocols permissible for compliance with paragraph (f)(3)(ii).

I. "Isoamyl Acetate Protocol"

A. Odor threshold screening.

1. Three 1-liter glass jars with metal lids (e.g. Mason or Bell jars) are required.

2. Odor-free water (e.g. distilled or spring water) at approximately 25 deg. C shall be used for the solutions.

4. The screening test shall be conducted in a room separate from the room used for actual fit testing. The two rooms shall be well ventilated but may not be connected to the same recirculating ventilation system.

5. The odor test solution is prepared in a second jar by placing .4 cc of the stock solution into 500 cc of odor free water using a clean dropper or pipette. Shake for 30 seconds and allow to stand for two to three minutes so that the IAA concentration above the liquid may reach equilibrium. This solution may be used for only one day.

6. A test blank is prepared in a third jar by adding 500 cc of odor free water.

7. The odor test and test blank jars shall be labelled 1 and 2 for jar identification. If the labels are put on the lids they can be periodically dried off and switched to avoid people thinking the same jar always has the IAA.

8. The following instructions shall be typed on a card and placed on the table in front of the two test jars (i.e. 1 and 2);

"The purpose of this test is to determine if you can smell banana oil at a low concentration. The two bottles in front of you contain water. One of these bottles also contains a small amount of banana oil. Be sure the covers are on tight, then shake each bottle for two seconds. Unscrew the lid of each bottle, one at a time, and sniff at the mouth of the bottle. Indicate to the test conductor which bottle contains banana oil."

9. The mixtures used in the IAA odor detection test shall be prepared in an area separate from where the test is performed, in order to prevent olfactory fatigue in the subject.

10. If the test subject is unable to correctly identify the jar containing the odor test solution, the IAA QLFT may not be used.

11. If the test subject correctly identifies the jar containing the odor test solution he may proceed to respirator selection and fit testing.

B. Respirator selection.

1. The test subject shall be allowed to select the most comfortable respirator from a large array of various sizes and manufacturers that includes at least three sizes of elastomeric half facepieces and units of at least two manufacturers.

2. The selection process shall be conducted in a room separate from the fit-test chamber to prevent odor fatigue. Prior to the selection process, the test subject shall be shown how to put on a respirator, how it should be positioned on the face, how to set strap tension and how to assess an "comfortable" respirator. A mirror shall be available to assist the subject in evaluating the fit and positioning of the respirator. This may not constitute his formal training on respirator use, only a review.

3. The test subject should understand that he is being asked to select the respirator which provides the most comfortable fit for him. Each respirator represents a different size and shape and, if fit properly, will provide adequate protection.

4. The test subject holds each facepiece up to his face and eliminates those which are obviously not giving a comfortable fit. Normally, selection will begin with a half-mask and if a fit cannot be found here, the subject will be asked to go to the full facepiece respirators. (A small percentage of users will not be able to wear any half-mask.) 5. The more comfortable facepieces are recorded; the most comfortable mask is donned and worn at least five minutes to assess comfort. Assistance in assessing comfort can be given by discussing the points in number 6 below. If the test subject is not familiar with using a particular respirator, he shall be directed to don the mask several times and to adjust the straps each time, so that he becomes adept at setting proper tension on the straps.

6. Assessment of comfort shall include reviewing the following points with the test subject:

. Chin properly placed. . Positioning of mask on nose. . Strap tension. . Fit across nose bridge. . Room for safety glasses. . Distance from nose to chin. . Room to talk. . Tendency to slip. . Cheeks filled out. . Self-observation in mirror. . Adequate time for assessment.

7. The test subject shall conduct the conventional negative and positive-pressure fit checks (e.g. see ANSI Z88.2-1980). Before conducting the negative- or positive-pressure checks, the subject shall be told to "seat" his mask by rapidly moving the head side-to-side and up and down, taking a few deep breaths.

8. The test subject is now ready for fit testing.

9. After passing the fit test, the test subject shall be questioned again regarding the comfort of the respirator. If it has become uncomfortable, another model of respirator shall be tried.

10. The employee shall be given the opportunity to select a different facepiece and be retested if during the first two weeks of on-the-job wear the chosen facepiece becomes unacceptably uncomfortable.

C. Fit test.

1. The fit test chamber shall be substantially similar to a clear 55 gallon drum liner suspended inverted over a 2 foot diameter frame, so that the top of chamber is about 6 inches above the test subject's head. The inside top center of the chamber shall have a small hook attached.

3. After selecting, donning, and properly adjusting a respirator himself, the test subject shall wear it to the fit testing room. This room shall be separate from the room used for odor threshold screening and respirator selection, and shall be well ventilated, as by an exhaust fan or lab hook, to prevent general room contamination.

4. A copy of the following test exercises and rainbow (or equally effective) passage shall be taped to the inside of the test chamber:

"Test Exercises "

i. Normal breathing.

ii. Deep breathing. Be certain breaths are "deep" and "regular".

iii. Turning head from side-to-side. Be certain movement is complete.

Alert the test subject not to bump the respirator on the shoulders. Have the test subject inhale when his head is at either side.

iv. Nodding head up-and-down. Be certain motions are complete and made about every second. Alert the test subject not bump the respirator on the chest. Have the test subject inhale when his head is in the fully up position.

"Rainbow Passage"

When the sunlight strikes raindrops in the air, they act like a prism and form a rainbow. The rainbow is a division of white light into many beautiful colors. These take the shape of a long round arch, with its path high above, and its two ends apparently beyond the horizon. There is, according to legend, a boiling pot of gold at one end. People look, but no one ever finds it. When a man looks for something beyond reach, his friends say he is looking for the pot of gold at the end of the rainbow.

vi. Normal breathing.

5. Each test subject shall wear his respirator for at least 10 minutes before starting the fit test.

7. Allow two minutes for the IAA test concentration to be reached before starting the fit-test exercises. This would be an appropriate time to talk with the test subject, to explain the fit test, the importance of his cooperation, the purpose for the head exercises, or to demonstrate some of the exercises.

8. Each exercise described in No. 4 above shall be performed for at least one minute.

9. If at any time during the test, the subject detects the banana-like odor of IAA, he shall quickly exit from the test chamber and leave the test area to avoid olfactory fatigue.

10. Upon returning to the selection room, the subject shall remove the respirator, repeat the odor sensitivity test, select and put on another respirator, return to the test chamber, etc. The process continues until a respirator that fits well has been found. Should the odor sensitivity test be failed, the subject shall wait about 5 minutes before retesting. Odor sensitivity will usually have returned by this time.

11. If a person cannot be fitted with the selection of half-mask respirators, include full facepiece models in the selection process. When a respirator is found that passes the test, its efficiency shall be demonstrated for the subject by having him break the face seal and take a breath before exiting the chamber.

12. When the test subject leaves the chamber he shall remove the saturated towel, returning it to the test conductor. To keep the area from becoming contaminated, the used towels shall be kept in a self-sealing bag. There is no significant IAA concentration buildup in the test chamber from subsequent tests.

13. Persons who have successfully passed this fit test may be assigned the use of the tested respirator in atmospheres with up to 10 times the PEL of airborne lead. In other words this IAA protocol may be used to assign a protection factor no higher than 10.

II. "Saccharin Solution Aerosol Protocol"

A. Taste threshold screening.

1. Threshold screening as well as fit testing employees shall use an enclosure about the head and shoulders that is approximately 12 inches in diameter by 14 inches tall with at least the front portion clear and that allows free movement of the head when a respirator is worn. An enclosure substantially similar to the 3M hood assembly of part number FT 14 and FT 15 combined is adequate.

2. The test enclosure shall have a three-quarter inch hole in front of the test subject's nose and mouth area to accommodate the nebulizer nozzle.

3. The entire screening and testing procedure shall be explained to the test subject prior to the conduct of the screening test.

4. The test subject shall don the test enclosure. For the threshold screening test, he shall breath through his open mouth with tongue extended.

6. The threshold check solution consists of 0.83 grams of sodium saccharin, USP in water. It can be prepared by putting 1 cc of the test solution (see C6 below) in 100 cc of water.

7. To produce the aerosol, the nebulizer bulb is firmly squeezed so that it collapses completely then released and allowed to fully expand.

8. Ten squeezes are repeated rapidly and then the test subject is asked whether the saccharin can be tasted.

9. If the first response is negative, ten more squeezes are repeated rapidly and the test subject is again asked whether the saccharin is tasted.

10. If the second response is negative ten more squeezes are repeated rapidly and the test subject is again asked whether the saccharin is tasted.

11. The test conductor will take note of the number of squeezes required to elicit a taste response.

12. If the saccharin is not tasted after 30 squeezes (Step 9), the test subject may not perform the saccharin fit test.

13. If a taste response is elicited, the test subject shall be asked to take note of the taste for reference in the fit test.

14. Correct use of the nebulizer means that approximately 1 cc of liquid is used at a time in the nebulizer body.

15. The nebulizer shall be thoroughly rinsed in water, shaken dry, and refilled at least each morning and afternoon or at least every four hours.

B. Respirator selection. Respirators shall be selected as described in section IB above, except that each respirator shall be equipped with a particulate filter cartridge.

C. Fit test.

1. The fit test uses the same enclosure described in B1 and B2 above

2. Each test subject shall wear his respirator for at least 10 minutes before starting the fit test.

3. The test subject shall don the enclosure while wearing the respirator selected in section A above. This respirator shall be properly adjusted and equipped with a particulate filter cartridge.

4. The test subject may not eat, drink (except plain water), or chew gum for 15 minutes before the test.

5. A second DeVilbiss Model 40 Inhalation Medication Nebulizer or equivalent, is used to spray the fit test solution into the enclosure. This nebulizer shall be clearly marked to distinguish it from the screening test solution nebulizer.

6. The fit test solution is prepared by adding 83 grams of sodium saccharin to 100 cc of warm water.

7. As before, the test subject shall breathe through the open mouth with tongue extended.

8. The nebulizer is inserted into the hole in the front of the enclosure and the fit test solution is sprayed into the enclosure and the fit test solution is sprayed into the enclosure using the same technique as for the taste threshold screening and the same number of squeezes required to elicit a taste response in the screening. (See B 10 above).

9. After generation of the aerosol the test subject shall be instructed to perform the following exercises for one minute each.

i. Normal breathing.

ii. Deep breathing. Be certain breaths are "deep" and "regular".

iii. Turning head from side-to-side. Be certain movement is complete.

Alert the test subject not to bump the respirator on the shoulders. Have the test subject inhale when his head is at either side.

iv. Nodding head up-and-down. Be certain motions are complete. Alert the test subject not to bump the respirator on the chest. Have the test subject inhale when his head in the fully up position.

"Rainbow Passage"

When the sunlight strikes raindrops in the air, they act like a prism and form a rainbow. The rainbow is a division of white light into many beautiful colors. These take the shape of a long round arch, with its path high above, and its two ends apparently beyond the horizon. There is, according to legend, a boiling pot of gold at one end. People look, but no one ever finds it. When a man looks for something beyond his reach, his friends say he is looking for the pot of gold at the end of the rainbow.

10. Every 30 seconds, the aerosol concentration shall be replenished using one-half the number of squeeze as initially (C8).

11. The test subject shall so indicate to the test conductor if at any time during the fit test the taste of saccharin is detected.

12. If the saccharin is detected the fit is deemed unsatisfactory and a different respirator shall be tried.

13. Successful completion of the test protocol shall allow the use of the tested respirator in contaminated atmospheres up to 10 times the PEL. In other words this protocol may be used assign protection factors no higher than ten.

III. "Irritant Fume Protocol"

A. Respirator selection. Respirators shall be selected as described in section IB above, except that each respirator shall be equipped with high efficiency cartridges.

B. Fit test.

1. The test subject shall be allowed to smell a weak concentration of the irritant smoke to familiarize him with the characteristic odor of each.

2. The test subject shall properly don the respirator selected as above, and wear it for at least 10 minutes before starting the fit test.

3. The test conductor shall review this protocol with the test subject before testing.

4. The test subject shall perform the conventional positive pressure and negative pressure fit checks. Failure of either check shall be cause to select an alternate respirator.

5. Break both ends of a ventilation smoke tube containing stannic oxychloride, such as the MSA part No. 5645, or equivalent. Attach a short length of tubing to one end of the smoke tube. Attach the other end of the smoke tube to a low pressure air pump set to deliver 200 milliliters per minute.

6. Advise the test subject that the smoke can be irritating to the eyes and instruct him to keep his eyes closed while the test is performed.

7. The test conductor shall direct the stream of irritant smoke from the tube towards the faceseal area of the test subject. He shall begin at least 12 inches from the facepiece and gradually move to within one inch, moving around the whole perimeter of the mask.

8. The following exercises shall be performed while the respirator seal is being challenged by the smoke. Each shall be performed for one minute.

i. Normal breathing.

ii. Deep breathing. Be certain breaths are "deep" and "regular".

iii. Turning head from side-to-side. Be certain movement is complete.

Alert the test subject not to bump the respirator on the shoulders. Have test subject inhale when his head is at either side.

iv. Nodding head up-and-down. Be certain motions are complete. Alert the test subject not to bump the respirator on the chest. Have the test subject inhale when his head is in the fully up position.

v. Talking-slowly and distinctly, count backwards from 100.

vi. Normal breathing.

9. If the irritant smoke produces an involuntary reaction (cough) by the test subject, the test conductor shall stop the test. In this case the tested respirator is rejected and another respirator shall be selected.

10. Each test subject passing the smoke test without evidence of a response shall be given a sensitivity check of the smoke from the same tube to determine whether he reacts to the smoke. Failure to evoke a response shall void the fit test.

11. Steps B4, B7, B8 of this protocol shall be performed in a location with exhaust ventilation sufficient to prevent general contamination of the testing area by the irritant smoke.

12. Respirators successfully tested by the protocol may be used in contaminated atmospheres up to ten times the PEL. In other words this protocol may be used to assign protection factors not exceeding ten.

[58 FR 35618, July 1, 1993]

1915.1028 Benzene

(a) "Scope and application." (1) This section applies to all occupational exposures to benzene. Chemical Abstracts Service Registry No. 71-43-2, except as provided in paragraphs (a)(2) and (a)(3) of this section.

(2) This section does not apply to:

(i) The storage, transportation, distribution, dispensing, sale or use of gasoline, motor fuels, or other fuels containing benzene subsequent to its final discharge from bulk wholesale storage facilities, except that operations where gasoline or motor fuels are dispensed for more than 4 hours per day in an indoor location are covered by this section.

(ii) Loading and unloading operations at bulk wholesale storage facilities which use vapor control systems for all loading and unloading operations, except for the provisions of 29 CFR 1915.1200 as incorporated into this section and the emergency provisions of paragraphs (g) and (i)(4) of this section.

(iii) The storage, transportation, distribution or sale of benzene or liquid mixtures containing more than 0.1 percent benzene in intact containers or in transportation pipelines while sealed in such a manner as to contain benzene vapors or liquid, except for the provisions of 29 CFR 1915.1200 as incorporated into this section and the emergency provisions of paragraphs (g) and (i)(4) of this section.

(iv) Containers and pipelines carrying mixtures with less than 0.1 percent benzene and natural gas processing plants processing gas with less than 0.1 percent benzene.

(v) Work operations where the only exposure to benzene is from liquid mixtures containing 0.5 percent or less of benzene by volume, or the vapors released from such liquids until September 12, 1988; work operations where the only exposure to benzene is from liquid mixtures containing 0.3 percent or less of benzene by volume or the vapors released from such liquids from September 12, 1988, to September 12, 1989; and work operations where the only exposure to benzene is from liquid mixtures containing 0.1 percent or less of benzene by volume or the vapors released from such liquids after September 12, 1989; except that tire building machine operators using solvents with more than 0.1 percent benzene are covered by paragraph (i) of this section.

(vi) Oil and gas drilling, production and servicing operations.

(vii) Coke oven batteries.

(3) The cleaning and repair of barges and tankers which have contained benzene are excluded from paragraph (f) methods of compliance, paragraph (e)(1) exposure monitoring-general, and paragraph (e)(6) accuracy of monitoring. Engineering and work practice controls shall be used to keep exposures below 10 ppm unless it is proven to be not feasible.

(b) "Definitions."

"Action level" means an airborne concentration of benzene of 0.5 ppm calculated as an 8-hour time-weighted average.

"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.

"Benzene" (C(6)H(6)) (CAS Registry No. 71-43-2) means liquefied or gaseous benzene. It includes benzene contained in liquid mixtures and the benzene vapors released by these liquids. It does not include trace amounts of unreacted benzene contained in solid materials.

"Bulk wholesale storage facility" means a bulk terminal or bulk plant where fuel is stored prior to its delivery to wholesale customers.

"Container" means any barrel, bottle, can, cylinder, drum, reaction vessel, storage tank, or the like, but does not include piping systems.

"Day" means any part of a calendar day.

"Director" means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee.

"Emergency" means any occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment which may or does result in an unexpected significant release of benzene.

"Employee exposure" means exposure to airborne benzene which would occur if the employee were not using respiratory protective equipment.

"Regulated area" means any area where airborne concentrations of benzene exceed or can reasonably be expected to exceed, the permissible exposure limits, either the 8-hour time weighted average exposure of 1 ppm or the short-term exposure limit of 5 ppm for 15 minutes.

"Vapor control system" means any equipment used for containing the total vapors displaced during the loading of gasoline, motor fuel or other fuel tank trucks and the displacing of these vapors through a vapor processing system or balancing the vapor with the storage tank. This equipment also includes systems containing the vapors displaced from the storage tank during the unloading of the tank truck which balance the vapors back to the tank truck.

(c) "Permissible exposure limits (PELs)" - (1) "Time-weighted average limit (TWA)." The employer shall assure that no employee is exposed to an airborne concentration of benzene in excess of one part of benzene per million parts of air (1 ppm) as an 8-hour time-weighted average.

(2) "Short-term exposure limit (STEL)." The employer shall assure that no employee is exposed to an airborne concentration of benzene in excess of five (5) ppm as averaged over any 15 minute period.

(d) "Regulated areas." (1) The employer shall establish a regulated area wherever the airborne concentration of benzene exceeds or can reasonably be expected to exceed the permissible exposure limits, either the 8-hour time weighted average exposure of 1 ppm or the short-term exposure limit of 5 ppm for 15 minutes.

(2) Access to regulated areas shall be limited to authorized persons.

(3) Regulated areas shall be determined from the rest of the workplace in any manner that minimizes the number of employees exposed to benzene within the regulated area.

(e) "Exposure monitoring" - (1) "General." (i) Determinations of employee exposure shall be made from breathing zone air samples that are representative of each employee's average exposure to airborne benzene.

(ii) Representative 8-hour TWA employee exposures shall be determined on the basis of one sample or samples representing the full shift exposure for each job classification in each work area.

(iii) Determinations of compliance with the STEL shall be made from 15 minute employee breathing zone samples measured at operations where there is reason to believe exposures are high, such as where tanks are opened, filled, unloaded or gauged; where containers or process equipment are opened and where benzene is used for cleaning or as a solvent in an uncontrolled situation. The employer may use objective data, such as measurements from brief period measuring devices, to determine where STEL monitoring is needed.

(iv) Except for initial monitoring as required under paragraph (e)(2) of this section, where the employer can document that one shift will consistently have higher employee exposures for an operation, the employer shall only be required to determine representative employee exposure for that operation during the shift on which the highest exposure is expected.

(2) "Initial monitoring." (i) Each employer who has a place of employment covered under paragraph (a)(1) of this section shall monitor each of these workplaces and work operations to determine accurately the airborne concentrations of benzene to which employees may be exposed.

(ii) The initial monitoring required under paragraph (e)(2)(i) of this section shall be completed by 60 days after the effective date of this standard or within 30 days of the introduction of benzene into the workplace. Where the employer has monitored within one year prior to the effective date of this standard and the monitoring satisfies all other requirements of this section, the employer may rely on such earlier monitoring results to satisfy the requirements of paragraph (e)(2)(i) of this section.

(3) "Periodic monitoring and monitoring frequency." (i) If the monitoring required by paragraph (e)(2)(i) of this section reveals employee exposure at or above the action level but at or below the TWA, the employer shall repeat such monitoring for each such employee at least every year.

(ii) If the monitoring required by paragraph (e)(2)(i) of this section reveals employee exposure above the TWA, the employer shall repeat such monitoring for each such employee at least every six (6) months.

(iii) The employer may alter the monitoring schedule from every six months to annually for any employee for whom two consecutive measurements taken at least 7 days apart indicate that the employee exposure has decreased to the TWA or below, but is at or above the action level.

(iv) Monitoring for the STEL shall be repeated as necessary to evaluate exposures of employees subject to short term exposures.

(4) "Termination of monitoring." (i) If the initial monitoring required by paragraph (e)(2)(i) of this section reveals employee exposure to be below the action level the employer may discontinue the monitoring for that employee, except as otherwise required by paragraph (e)(5) of this section.

(ii) If the periodic monitoring required by paragraph (e)(3) of this section reveals that employee exposures, as indicated by at least two consecutive measurements taken at least 7 days apart, are below the action level the employer may discontinue the monitoring for that employee, except as otherwise required by paragraph (e)(5).

(5) "Additional monitoring." (i) The employer shall institute the exposure monitoring required under paragraphs (e)(2) and (e)(3) of this section when there has been a change in the production, process, control equipment, personnel or work practices which may result in new or additional exposures to benzene, or when the employer has any reason to suspect a change which may result in new or additional exposures.

(ii) Whenever spills, leaks, ruptures or other breakdowns occur that may lead to employee exposure, the employer shall monitor (using area or personal sampling) after the cleanup of the spill or repair of the leak, rupture or other breakdown to ensure that exposures have returned to the level that existed prior to the incident.

(6) "Accuracy of monitoring." Monitoring shall be accurate, to a confidence level of 95 percent, to within plus or minus 25 percent for airborne concentrations of benzene.

(7) "Employee notification of monitoring results." (i) The employer shall, within 15 working days after the receipt of the results of any monitoring performed under this standard, notify each employee of these results in writing either individually or by posting of results in an appropriate location that is accessible to affected employees.

(ii) Whenever the PELs are exceeded, the written notification required by paragraph (e)(7)(i) of this section shall contain the corrective action being taken by the employer to reduce the employee exposure to or below the PEL, or shall refer to a document available to the employee which states the corrective actions to be taken.

(f) "Methods of compliance" - (1) "Engineering controls and work practices." (i) The employer shall institute engineering controls and work practices to reduce and maintain employee exposure to benzene at or below the permissible exposure limits, except to the extent that the employer can establish that these controls are not feasible or where the provisions of paragraph (f)(1)(iii) or (g)(1) of this section apply.

(ii) Wherever the feasible engineering controls and work practices which can be instituted are not sufficient to reduce employee exposure to or below the PELs, the employer shall use them to reduce employee exposure to the lowest levels achievable by these controls and shall supplement them by the use of respiratory protection which complies with the requirements of paragraph (g) of this section.

(iii) Where the employer can document that benzene is used in a workplace less than a total of 30 days per year, the employer shall use engineering controls, work practice controls or respiratory protection or any combination of these controls to reduce employee exposure to benzene to or below the PELs, except that employers shall use engineering and work practice controls, if feasible, to reduce exposure to or below 10 ppm as an 8-hour TWA.

(2) "Compliance program." (i) When any exposures are over the PEL, the employer shall establish and implement a written program to reduce employee exposure to or below the PEL primarily by means of engineering and work practice controls, as required by paragraph (f)(1) of this section.

(ii) The written program shall include a schedule for development and implementation of the engineering and work practice controls. These plans shall be reviewed and revised as appropriate based on the most recent exposure monitoring data, to reflect the current status of the program.

(iii) Written compliance programs shall be furnished upon request for examination and copying to the Assistant Secretary, the Director, affected employees and designated employee representatives.

(g) "Respiratory protection." (1) "General." The employer shall provide respirators, and assure that they are used, where required by this section. Respirators shall be used in the following circumstances:

(i) During the time period necessary to install or implement feasible engineering and work practice controls;

(ii) In work operations for which the employer establishes that compliance with either the TWA or STEL through the use of engineering and work practice controls is not feasible, such as some maintenance and repair activities, vessel cleaning, or other operations where engineering and work practice controls are infeasible because exposures are intermittent in nature and limited in duration;

(iii) In work situations where feasible engineering and work practice controls are not yet sufficient or are not required under paragraph (f)(1)(iii) of this section to reduce exposure to or below the PELs; and

(iv) In emergencies.

(2) "Respirator selection." (i) Where respirators are required or allowed under this section, the employer shall select and provide, at no cost to the employee, the appropriate respirator as specified in Table 1, and shall assure that the employee uses the respirator provided.

(ii) The employer shall select respirators from among those jointly approved by the Mine Safety and Health Administration and the National Institute for Occupational Safety and Health under the provisions of 30 CFR Part 11. Negative pressure respirators shall have filter elements approved by MSHA/NIOSH for organic vapors or benzene.

(iii) Any employee who cannot wear a negative pressure respirator shall be given the option of wearing a respirator with less breathing resistance such as a powered air-purifying respirator or supplied air respirator.

(3) "Respirator program." The employer shall institute a respiratory protection program in accordance with 29 CFR 1910.134 (b), (d), (e) and (f).

(4) "Respirator use." (i) Where air-purifying respirators are used, the employer shall replace the air purifying element at the expiration of service life or at the beginning of each shift in which they will be used, whichever comes first.

(ii) If an air purifying element becomes available with an end of useful life indicator for benzene approved by MSHA/NIOSH, the element may be used until such time as the indicator shows no further useful life.

(iii) The employer shall permit employees who wear respirators to leave the regulated area to wash their faces and respirator facepieces as necessary in order to prevent skin irritation associated with respirator use or to change the filter elements of air-purifying respirators whenever they detect a change in breathing resistance or chemical vapor breakthrough.

(5) "Respirator fit testing." (i) The employer shall perform, and certify the results of, either quantitative or qualitative fit tests at the time of initial fitting and at least annually thereafter for each employee wearing a negative pressure respirator. The test shall be used to select a respirator facepiece which exhibits minimum leakage and provides the required protection as prescribed in Table 1. The employer shall provide and assure that the employee wears a respirator demonstrated by the fit test to provide the required protection.

(ii) The employer shall follow the test protocols outlined in Appendix E of this standard for whichever type of fit testing the employer chooses.

TABLE 1. - RESPIRATORY PROTECTION FOR BENZENE
Airborne concentration of benzene or condition of use	Respirator type
(a) Less than or equal to 10 ppm	(1) Half-mask air-purifying respirator with organic vapor cartridge.
(b) Less than or equal to 50 ppm	(1) Full facepiece respirator with organic vapor cartridges. (1) Full facepiece gas mask with chin style canister.(1)
(c) Less than or equal to 100 ppm	(1) Full facepiece powered air-purifying respirator with organic vapor canister.(1)
(d) Less than or equal to 1,000 ppm	(1) Supplied air respirator with full facepiece in positive-pressure mode.
(e) Greater than 1,000 ppm or unknown concentration	(1) Self-contained breathing apparatus with full facepiece in positive pressure mode. (2) Full facepiece positive-pressure supplied-air respirator with auxiliary self-contained air supply.
(f) Escape	(1) Any organic vapor gas mask; or (2) Any self-contained breathing apparatus with full facepiece.
(g) Firefighting	(1) Full facepiece self-contained breathing apparatus in positive pressure mode.

Footnote(1) Canisters must have a minimum service life of four (4) hours when tested at 150 ppm benzene, at a flow rate of 64 LPM, 25 deg. C, and 85 percent relative humidity for non-powered air purifying respirators. The flow rate shall be 115 LPM and 170 LPM respectively for tight fitting and loose fitting powered air-purifying respirators.

(h) "Protective clothing and equipment." Personal protective clothing and equipment shall be worn where appropriate to prevent eye contact and limit dermal exposure to liquid benzene. Protective clothing and equipment shall be provided by the employer at no cost to the employee and the employer shall assure its use where appropriate. Eye and face protection shall meet the requirements of 29 CFR 1910.133.

(i) "Medical surveillance" - (1) "General." (i) The employer shall make available a medical surveillance program for employees who are or may be exposed to benzene at or above the action level 30 or more days per year; for employees who are or may be exposed to benzene at or above the PELs 10 or more days per year; for employees who have been exposed to more than 10 ppm of benzene for 30 or more days in a year prior to the effective date of the standard when employed by their current employer; and for employees involved in the tire building operations called tire building machine operators, who use solvents containing greater than 0.1 percent benzene.

(ii) The employer shall assure that all medical examinations and procedures are performed by or under the supervision of a licensed physician and that all laboratory tests are conducted by an accredited laboratory.

(iii) The employer shall assure that persons other than licensed physicians who administer the pulmonary function testing required by this section shall complete a training course in spirometry sponsored by an appropriate governmental, academic or professional institution.

(iv) The employer shall assure that all examinations and procedures are provided without cost to the employee and at a reasonable time and place.

(2) "Initial examination." (i) Within 60 days of the effective date of this standard, or before the time of initial assignment, the employer shall provide each employee covered by paragraph (i)(1)(i) of this section with a medical examination including the following elements:

(A) A detailed occupational history which includes:

(1) Past work exposure to benzene or any other hematological toxins,

(2) A family history of blood dyscrasias including hematological neoplasms;

(3) A history of blood dyscrasias including genetic hemoglobin abnormalities, bleeding abnormalities, abnormal function of formed blood elements;

(4) A history of renal or liver dysfunction;

(5) A history of medicinal drugs routinely taken;

(6) A history of previous exposure to ionizing radiation and

(7) Exposure to marrow toxins outside of the current work situation.

(B) A complete physical examination.

(C) "Laboratory tests." A complete blood count including a leukocyte count with differential, a quantitative thrombocyte count, hematocrit, hemoglobin, erythrocyte count and erythrocyte indices (MCV, MCH, MCHC). The results of these tests shall be reviewed by the examining physician.

(D) Additional tests as necessary in the opinion of the examining physician, based on alterations to the components of the blood or other signs which may be related to benzene exposure; and

(E) For all workers required to wear respirators for at least 30 days a year, the physical examination shall pay special attention to the cardiopulmonary system and shall include a pulmonary function test.

(ii) No initial medical examination is required to satisfy the requirements of paragraph (i)(2)(i) of this section if adequate records show that the employee has been examined in accordance with the procedures of paragraph (i)(2)(i) of this section within the twelve months prior to the effective date of this standard.

(3) "Periodic examinations." (i) The employer shall provide each employee covered under paragraph (i)(1)(i) of this section with a medical examination annually following the previous examination. These periodic examinations shall include at least the following elements:

(A) A brief history regarding any new exposure to potential marrow toxins, changes in medicinal drug use, and the appearance of physical signs relating to blood disorders:

(B) A complete blood count including a leukocyte count with differential, quantitative thrombocyte count, hemoglobin, hematocrit, erythrocyte count and erythrocyte indices (MCV, MCH, MCHC); and

(C) Appropriate additional tests as necessary, in the opinion of the examining physician, in consequence of alterations in the components of the blood or other signs which may be related to benzene exposure.

(ii) Where the employee develops signs and symptoms commonly associated with toxic exposure to benzene, the employer shall provide the employee with an additional medical examination which shall include those elements considered appropriate by the examining physician.

(iii) For persons required to use respirators for at least 30 days a year, a pulmonary function test shall be performed every three (3) years. A specific evaluation of the cardiopulmonary system shall be made at the time of the pulmonary function test.

(4) "Emergency examinations." (i) In addition to the surveillance required by (i)(1)(i), if an employee is exposed to benzene in an emergency situation, the employer shall have the employee provide a urine sample at the end of the employee's shift and have a urinary phenol test performed on the sample within 72 hours. The urine specific gravity shall be corrected to 1.024.

(ii) If the result of the urinary phenol test is below 75 mg phenol/L of urine, no further testing is required.

(iii) If the result of the urinary phenol test is equal to or greater than 75 mg phenol/L of urine, the employer shall provide the employee with a complete blood count including an erythrocyte count, leukocyte count with differential and thrombocyte count at monthly intervals for a duration of three (3) months following the emergency exposure.

(iv) If any of the conditions specified in paragraph (i)(5)(i) of this section exists, then the further requirements of paragraph (i)(5) of this section shall be met and the employer shall, in addition, provide the employees with periodic examinations if directed by the physician.

(5) "Additional examinations and referrals." (i) Where the results of the complete blood count required for the initial and periodic examinations indicate any of the following abnormal conditions exist, then the blood count shall be repeated within 2 weeks.

(A) The hemoglobin level or the hematocrit falls below the normal limit [outside the 95 percent confidence interval (C.I.)] as determined by the laboratory for the particular geographic area and/or these indices show a persistent downward trend from the individual's pre-exposure norms; provided these findings cannot be explained by other medical reasons.

(B) The thrombocyte (platelet) count varies more than 20 percent below the employee's most recent values or falls outside the normal limit (95 percent C.I.) as determined by the laboratory.

(ii) If the abnormality persists, the examining physician shall refer the employee to a hematologist or an internist for further evaluation unless the physician has good reason to believe such referral is unnecessary. (See Appendix C for examples of conditions where a referral may be unnecessary.) (iii) The employer shall provide the hematologist or internist with the information required to be provided to the physician under paragraph (i)(6) of this section and the medical record required to be maintained by paragraph (k)(2)(ii) of this section.

(iv) The hematologist's or internist's evaluation shall include a determination as to the need for additional tests, and the employer shall assure that these tests are provided.

(6) "Information provided to the physician." The employer shall provide the following information to the examining physician:

(i) A copy of this regulation and its appendices;

(ii) A description of the affected employee's duties as they relate to the employee's exposure;

(iii) The employee's actual or representative exposure level:

(iv) A description of any personal protective equipment used or to be used; and

(v) Information from previous employment-related medical examinations of the affected employee which is not otherwise available to the examining physician.

(7) "Physician's written opinions." (i) For each examination under this section, the employer shall obtain and provide the employee with a copy of the examining physician's written opinion within 15 days of the examination. The written opinion shall be limited to the following information:

(A) The occupationally pertinent results of the medical examination and tests;

(B) The physician's opinion concerning whether the employee has any detected medical conditions which would place the employee's health at greater than normal risk of material impairment from exposure to benzene;

(C) The physician's recommended limitations upon the employee's exposure to benzene or upon the employee's use of protective clothing or equipment and respirators.

(D) A statement that the employee has been informed by the physician of the results of the medical examination and any medical conditions resulting from benzene exposure which require further explanation or treatment.

(ii) The written opinion obtained by the employer shall not reveal specific records, findings and diagnoses that have no bearing on the employee's ability to work in a benzene-exposed workplace.

(8) "Medical removal plan." (i) When a physician makes a referral to a hematologist/internist as required under paragraph (i)(5)(ii) of this section, the employee shall be removed from areas where exposures may exceed the action level until such time as the physician makes a determination under paragraph (i)(8)(ii) of this section.

(ii) Following the examination and evaluation by the hematologist/internist, a decision to remove an employee from areas where benzene exposure is above the action level or to allow the employee to return to areas where benzene exposure is above the action level shall be made by the physician in consultation with the hematologist/internist. This decision shall be communicated in writing to the employer and employee. In the case of removal, the physician shall state the required probable duration of removal from occupational exposure to benzene above the action level and the requirements for future medical examinations to review the decision.

(iii) For any employee who is removed pursuant to paragraph (i)(8)(ii) of this section, the employer shall provide a follow-up examination. The physician, in consultation with the hematologist/internist, shall make a decision within 6 months of the date the employee was removed as to whether the employee shall be returned to the usual job or whether the employee should be removed permanently.

(iv) Whenever an employee is temporarily removed from benzene exposure pursuant to paragraph (i)(8)(i) or (i)(8)(ii) of this section, the employer shall transfer the employee to a comparable job for which the employee is qualified (or can be trained for in a short period) and where benzene exposures are as low as possible, but in no event higher than the action level. The employer shall maintain the employee's current wage rate, seniority and other benefits. If there is no such job available, the employer shall provide medical removal protection benefits until such a job becomes available or for 6 months, whichever comes first.

(v) Whenever an employee is removed permanently from benzene exposure based on a physician's recommendation pursuant to paragraph (i)(8)(iii) of this section, the employee shall be given the opportunity to transfer to another position which is available or later becomes available for which the employee is qualified (or can be trained for in a short period) and where benzene exposures are as low as possible but in no event higher than the action level. The employer shall assure that such employee suffers no reduction in current wage rate, seniority or other benefits as a result of the transfer.

(9) "Medical removal protection benefits." (i) The employer shall provide to an employee 6 months of medical removal protection benefits immediately following each occasion an employee is removed from exposure to benzene because of hematological findings pursuant to paragraphs (i)(8)(i) and (ii) of this section, unless the employee has been transferred to a comparable job where benzene exposures are below the action level.

(ii) For the purposes of this section, the requirement that an employer provide medical removal protection benefits means that the employer shall maintain the current wage rate, seniority and other benefits of an employee as though the employee had not been removed.

(iii) The employer's obligation to provide medical removal protection benefits to a removed employee shall be reduced to the extent that the employee receives compensation for earnings lost during the period of removal either from a publicly or employer-funded compensation program, or from employment with another employer made possible by virtue of the employee's removal.

(j) "Communication of benzene hazards to employees" - (1) "Signs and labels." (i) The employer shall post signs at entrances to regulated areas. The signs shall bear the following legend:

DANGER
BENZENE
CANCER HAZARD
FLAMMABLE - NO SMOKING
AUTHORIZED PERSONNEL ONLY
RESPIRATOR REQUIRED

(ii) The employer shall ensure that labels or other appropriate forms of warning are provided for containers of benzene within the workplace. There is no requirement to label pipes. The labels shall comply with the requirements of 29 CFR 1915.1200(f) and in addition shall include the following legend:

DANGER
CONTAINS BENZENE
CANCER HAZARD

(2) "Material safety data sheets." (i) Employers shall obtain or develop, and shall provide access to their employees, to a material safety data sheet (MSDS) which addresses benzene and complies with 29 CFR 1915.1200.

(ii) Employers who are manufacturers or importers shall:

(A) Comply with paragraph (a) of this section, and

(B) Comply with the requirement in OSHA's Hazard Communication Standard, 29 CFR 1915.1200, that they deliver to downstream employers an MSDS which addresses benzene.

(3) "Information and training." (i) The employer shall provide employees with information and training at the time of their initial assignment to a work area where benzene is present. If exposures are above the action level, employees shall be provided with information and training at least annually thereafter.

(ii) The training program shall be in accordance with the requirements of 29 CFR 1915.1200(h)(1) and (2), and shall include specific information on benzene for each category of information included in that section.

(iii) In addition to the information required under 29 CFR 1915.1200, the employer shall:

(A) Provide employees with an explanation of the contents of this section, including Appendices A and B, and indicate to them where the standard is available; and

(B) Describe the medical surveillance program required under paragraph (i) of this section, and explain the information contained in Appendix C.

(k) "Recordkeeping" - (1) "Exposure measurements." (i) The employer shall establish and maintain an accurate record of all measurements required by paragraph (e) of this section, in accordance with 29 CFR 1915.1120.

(ii) This record shall include:

(A) The dates, number, duration, and results of each of the samples taken, including a description of the procedure used to determine representative employee exposures;

(B) A description of the sampling and analytical methods used;

(D) The name, social security number, job classification and exposure levels of the employee monitored and all other employees whose exposure the measurement is intended to represent.

(iii) The employer shall maintain this record for at least 30 years, in accordance with 29 CFR 1915.1120.

(2) "Medical surveillance." (i) The employer shall establish and maintain an accurate record for each employee subject to medical surveillance required by paragraph (i) of this section, in accordance with 29 CFR 1915.1120.

(ii) This record shall include:

(A) The name and social security number of the employee;

(B) The employer's copy of the physician's written opinion on the initial, periodic and special examinations, including results of medical examinations and all tests, opinions and recommendations;

(D) A copy of the information provided to the physician as required by paragraphs (i)(6) (ii) through (v) of this section; and

(E) A copy of the employee's medical and work history related to exposure to benzene or any other hematologic toxins.

(iii) The employer shall maintain this record for at least the duration of employment plus 30 years, in accordance with 29 CFR 1915.1120.

(3) "Availability." (i) The employer shall assure that all records required to be maintained by this section shall be made available upon request to the Assistant Secretary and the Director for examination and copying.

(ii) Employee exposure monitoring records required by this paragraph shall be provided upon request for examination and copying to employees, employee representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120 (a) through (e) and (g) through (i).

(iii) Employee medical records required by this paragraph shall be provided upon request for examination and copying, to the subject employee, to anyone having the specific written consent of the subject employee, and to the Assistant Secretary in accordance with 29 CFR 1915.1120.

(4) "Transfer of records." (i) The employer shall comply with the requirements involving transfer of records set forth in 29 CFR 1915.1120(h).

(ii) If the employer ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, the employer shall notify the Director, at least three (3) months prior to disposal, and transmit them to the Director if required by the Director within that period.

(l) "Observation of monitoring" - (1) "Employee observation." The employer shall provide affected employees, or their designated representatives, an opportunity to observe the measuring or monitoring of employee exposure to benzene conducted pursuant to paragraph (e) of this section.

(2) "Observation procedures." When observation of the measuring or monitoring of employee exposure to benzene requires entry into areas where the use of protective clothing and equipment or respirators is required, the employer shall provide the observer with personal protective clothing and equipment or respirators required to be worn by employees working in the area, assure the use of such clothing and equipment or respirators, and require the observer to comply with all other applicable safety and health procedures.

(m) "Dates" - (1) "Effective date." The standard shall become effective December 10, 1987.

(2) "Start-up dates." (i) The requirements of paragraph (a) through (m) of this section, except the engineering control requirements of paragraph (f)(1) of this section shall be completed within sixty (60) days after the effective date of the standard.

(ii) Engineering and work practice controls required by paragraph (f)(1) of this section shall be implemented no later than 2 years after the effective date of the standard.

(iii) Coke and coal chemical operations may comply with paragraph (m)(2)(ii) of this section or alternately include within the compliance program required by paragraph (f)(2) of this section, a requirement to phase in engineering controls as equipment is repaired and replaced. For coke and coal chemical operations choosing the latter alternative, compliance with the engineering controls requirements of paragraph (f)(1) of this section shall be achieved no later than 5 years after the effective date of this standard and substantial compliance with the engineering control requirements shall be achieved within 3 years of the effective date of this standard.

(n) "Appendices." The information contained in Appendices A, B, C, and D is not intended, by itself, to create any additional obligations not otherwise imposed or to detract from any existing obligations. The protocols on respiratory fit testing in Appendix E are mandatory.

(Approved by the Office of Management and Budget under control number 1218-0129)

[58 FR 35620, July 1, 1993]

1915.1028 Appendix A Substance Safety Data Sheet, Benzene.

I. "Substance Identification"

A. Substance: Benzene.

B. Permissible Exposure: Except as to the use of gasoline, motor fuels and other fuels subsequent to discharge from bulk terminals and other exemptions specified in 1915.1028(a)(2):

1. Airborne: The maximum time-weighted average (TWA) exposure limit is 1 part of benzene vapor per million parts of air (1 ppm) for an 8-hour workday and the maximum short-term exposure limit (STEL) is 5 ppm for any 15-minute period.

2. Dermal: Eye contact shall be prevented and skin contact with liquid benzene shall be limited.

C. Appearance and odor: Benzene is a clear, colorless liquid with a pleasant, sweet odor. The odor of benzene does not provide adequate warning of its hazard.

II. "Health Hazard Data"

A. "Ways in which benzene affects your health." Benzene can affect your health if you inhale it, or if it comes in contact with your skin or eyes. Benzene is also harmful if you happen to swallow it.

B. "Effects of overexposure." 1. Short-term (acute) overexposure: If you are overexposed to high concentrations of benzene, well above the levels where its odor is first recognizable, you may feel breathless, irritable, euphoric, or giddy; you may experience irritation in eyes, nose, and respiratory tract. You may develop a headache, feel dizzy, nauseated, or intoxicated. Severe exposures may lead to convulsions and loss of consciousness.

2. Long-term (chronic) exposure. Repeated or prolonged exposure to benzene, even at relatively low concentrations, may result in various blood disorders, ranging from anemia to leukemia, an irreversible, fatal disease. Many blood disorders associated with benzene exposure may occur without symptoms.

III. "Protective Clothing and Equipment"

A. "Respirators." Respirators are required for those operations in which engineering controls or work practice controls are not feasible to reduce exposure to the permissible level. However, where employers can document that benzene is present in the workplace less than 30 days a year, respirators may be used in lieu of engineering controls. If respirators are worn, they must have joint Mine Safety and Health Administration and the National Institute for Occupational Safety and Health (NIOSH) seal of approval, and cartridge or canisters must be replaced before the end of their service life, or the end of the shift, whichever occurs first. If you experience difficulty breathing while wearing a respirator, you may request a positive pressure respirator from your employer. You must be thoroughly trained to use the assigned respirator, and the training will be provided by your employer.

B. "Protective Clothing." You must wear appropriate protective clothing (such as boots, gloves, sleeves, aprons, etc.) over any parts of your body that could be exposed to liquid benzene.

C. "Eye and Face Protection." You must wear splash-proof safety goggles if it is possible that benzene may get into your eyes. In addition, you must wear a face shield if your face could be splashed with benzene liquid.

IV. "Emergency and First Aid Procedures"

A. "Eye and face exposure." If benzene is splashed in your eyes, wash it out immediately with large amounts of water. If irritation persists or vision appears to be affected see a doctor as soon as possible.

B. "Skin exposure." If benzene is spilled on your clothing or skin, remove the contaminated clothing and wash the exposed skin with large amounts of water and soap immediately. Wash contaminated clothing before you wear it again.

C. "Breathing." If you or any other person breathes in large amounts of benzene, get the exposed person to fresh air at once. Apply artificial respiration if breathing has stopped. Call for medical assistance or a doctor as soon as possible. Never enter any vessel or confined space where the benzene concentration might be high without proper safety equipment and at least one other person present who will stay outside. A life line should be used.

D. "Swallowing." If benzene has been swallowed and the patient is conscious, do not induce vomiting. Call for medical assistance or a doctor immediately.

V. "Medical Requirements"

If you are exposed to benzene at a concentration at or above 0.5 ppm as an 8-hour time-weighted average, or have been exposed at or above 10 ppm in the past while employed by your current employer, your employer is required to provide a medical examination and history and laboratory tests within 60 days of the effective date of this standard and annually thereafter. These tests shall be provided without cost to you. In addition, if you are accidentally exposed to benzene (either by ingestion, inhalation, or skin/eye contact) under emergency conditions known or suspected to constitute toxic exposure to benzene, your employer is required to make special laboratory tests available to you.

VI. "Observation of Monitoring"

Your employer is required to perform measurements that are representative of your exposure to benzene and you or your designated representative are entitled to observe the monitoring procedure. You are entitled to observe the steps taken in the measurement procedure, and to record the results obtained. When the monitoring procedure is taking place in an area where respirators or personal protective clothing and equipment are required to be worn, you or your representative must also be provided with, and must wear the protective clothing and equipment.

VII. "Access to Records"

You or your representative are entitled to see the records of measurements of your exposure to benzene upon written request to your employer. Your medical examination records can be furnished to yourself, your physician or designated representative upon request by you to your employer.

VIII. "Precautions for Safe Use, Handling and Storage"

Benzene liquid is highly flammable. It should be stored in tightly closed containers in a cool, well ventilated area. Benzene vapor may form explosive mixtures in air. All sources of ignition must be controlled. Use nonsparking tools when opening or closing benzene containers. Fire extinguishers, where provided, must be readily available. Know where they are located and how to operate them. Smoking is prohibited in areas where benzene is used or stored. Ask your supervisor where benzene is used in your area and for additional plant safety rules.

[58 FR 35625, July 1, 1993]

1915.1028 App B Substance Technical Guidelines, Benzene.

I. "Physical and Chemical Data"

A. Substance identification. 1. "Synonyms:" Benzol, benzole, coal naphtha, cyclohexatriene, phene, phenyl hydride, pyrobenzol. (Benzin, petroleum benzin and Benzine do not contain benzene).

2. "Formula:" C(6)H(6) (CAS Registry Number: 71-43-2)

B. Physical data. 1. Boiling Point (760 mm Hg); 80.1 deg. C (176 deg. F) 2. Specific Gravity (water = 1): 0.879 3. Vapor Density (air = 1): 2.7 4. Melting Point: 5.5 deg. C (42 deg. F) 5. Vapor Pressure at 20 deg. C (68 deg. F): 75 mm Hg 6. Solubility in Water: .06 percent 7. Evaporation Rate (ether = 1): 2.8 8. Appearance and Odor: Clear, colorless liquid with a distinctive sweet odor.

II. "Fire, Explosion, and Reactivity Hazard Data"

A. Fire. 1. Flash Point (closed cup): -11 deg. C (12 deg. F) 2. Autoignition Temperature: 580 deg. C (1076 deg. F) 3. Flammable limits in Air. percent by Volume: Lower: 1.3 percent, Upper: 7.5 percent 4. Extinguishing Media: Carbon dioxide, dry chemical, or foam. 5. Special Fire-Fighting procedures: Do not use solid stream of water, since stream will scatter and spread fire. Fine water spray can be used to keep fire-exposed containers cool.

6. Unusual fire and explosion hazards: Benzene is a flammable liquid. Its vapors can form explosive mixtures. All ignition sources must be controlled when benzene is used, handled, or stored. Where liquid or vapor may be released, such areas shall be considered as hazardous locations. Benzene vapors are heavier than air; thus the vapors may travel along the ground and be ignited by open flames or sparks at locations remote from the site at which benzene is handled.

7. Benzene is classified as a 1 B flammable liquid for the purpose of conforming to the requirements of 29 CFR 1910.106. A concentration exceeding 3,250 ppm is considered a potential fire explosion hazard. Locations where benzene may be present in quantities sufficient to produce explosive or ignitable mixtures are considered Class I Group D for the purposes of conforming to the requirements of 29 CFR 1910.309.

B. Reactivity. 1. Conditions contributing to instability: Heat. 2. Incompatibility: Heat and oxidizing materials. 3. Hazardous decomposition products: Toxic gases and vapors (such as carbon monoxide).

III. "Spill and Leak Procedures"

A. Steps to be taken if the material is released or spilled. As much benzene as possible should be absorbed with suitable materials, such as dry sand or earth. That remaining must be flushed with large amounts of water. Do not flush benzene into a confined space, such as a sewer, because of explosion danger. Remove all ignition sources. Ventilate enclosed places.

B. Waste disposal method. Disposal methods must conform to other jurisdictional regulations. If allowed, benzene may be disposed of: (a) By absorbing it in dry sand or earth and disposing in a sanitary landfill; (b) if small quantities, by removing it to a safe location from buildings or other combustible sources, pouring it in dry sand or earth and cautiously igniting it; and (c) if large quantities, by atomizing it in a suitable combustion chamber.

IV. "Miscellaneous Precautions"

A. High exposure to benzene can occur when transferring the liquid from one container to another. Such operations should be well ventilated and good work practices must be established to avoid spills.

B. Use non-sparking tools to open benzene containers which are effectively grounded and bonded prior to opening and pouring.

C. Employers must advise employees of all plant areas and operations where exposure to benzene could occur. Common operations in which high exposures to benzene may be encountered are: the primary production and utilization of benzene, and transfer of benzene.

[58 FR 35626, July 1, 1993]

1915.1028 Appendix C Medical Surveillance Guidelines for Benzene.

I. "Route of Entry"

Inhalation; skin absorption.

II. "Toxicology"

Benzene is primarily an inhalation hazard. Systemic absorption may cause depression of the hematopoietic system, pancytopenia, aplastic anemia, and leukemia. Inhalation of high concentrations can affect central nervous system function. Aspiration of small amounts of liquid benzene immediately causes pulmonary edema and hemorrhage of pulmonary tissue. There is some absorption through the skin. Absorption may be more rapid in the case of abraded skin, and benzene may be more readily absorbed if it is present in a mixture or as a contaminant in solvents which are readily absorbed. The defatting action of benzene may produce primary irritation due to repeated or prolonged contact with the skin. High concentration are irritating to the eyes and the mucous membranes of the nose, and respiratory tract.

III. "Signs and Symptoms"

Direct skin contact with benzene may cause erythema. Repeated or prolonged contact may result in drying, scaling dermatitis, or development of secondary skin infections. In addition, there is benzene absorption through the skin. Local effects of benzene vapor or liquid on the eye are slight. Only at very high concentrations is there any smarting sensation in the eye. Inhalation of high concentrations of benzene may have an initial stimulatory effect on the central nervous system characterized by exhilaration, nervous excitation, and/or giddiness, followed by a period of depression, drowsiness, or fatigue. A sensation of tightness in the chest accompanied by breathlessness may occur and ultimately the victim may lose consciousness. Tremors, convulsions and death may follow from respiratory paralysis or circulatory collapse in a few minutes to several hours following severe exposures.

The detrimental effect on the blood-forming system of prolonged exposure to small quantities of benzene vapor is of extreme importance. The hematopoietic system is the chief target for benzene's toxic effects which are manifested by alterations in the levels of formed elements in the peripheral blood. These effects have occurred at concentrations of benzene which may not cause irritation of mucous membranes, or any unpleasant sensory effects. Early signs and symptoms of benzene morbidity are varied, often not readily noticed and non-specific. Subjective complaints of headache, dizziness, and loss of appetite may precede or follow clinical signs. Rapid pulse and low blood pressure, in addition to a physical appearance of anemia, may accompany a subjective complaint of shortness of breath and excessive tiredness. Bleeding from the nose, gums, or mucous membranes, and the development of purpuric spots (small bruises) may occur as the condition progresses. Clinical evidence of leukopenia, anemia, and thrombocytopenia, singly or in combination, has been frequently reported among the first signs.

Bone marrow may appear normal, aplastic, or hyperplastic, and may not, in all situations, correlate with peripheral blood forming tissues. Because of variations in the susceptibility to benzene morbidity, there is no "typical" blood picture. The onset of effects of prolonged benzene exposure may be delayed for many months or years after the actual exposure has ceased and identification or correlation with benzene exposure must be sought out in the occupational history.

IV. "Treatment of Acute Toxic Effects"

Remove from exposure immediately. Make sure you are adequately protected and do not risk being overcome by fumes. Give oxygen or artificial resuscitation if indicated. Flush eyes, wash skin if contaminated and remove all contaminated clothing. Symptoms of intoxication may persist following severe exposures. Recovery from mild exposures is usually rapid and complete.

V. "Surveillance and Preventive Considerations"

A. General

The principal effects of benzene exposure which form the basis for this regulation are pathological changes in the hematopoietic system, reflected by changes in the peripheral blood and manifesting clinically as pancytopenia, aplastic anemia, and leukemia. Consequently, the medical surveillance program is designed to observe, on a regular basis, blood indices for early signs of these effects, and although early signs of leukemia are not usually available, emerging diagnostic technology and innovative regimes make consistent surveillance for leukemia, as well as other hematopoietic effects, essential.

Initial examinations are to be provided within 60 days of the effective date of this standard, or at the time of initial assignment, and periodic examinations annually thereafter. There are special provisions for medical tests in the event of hematologic abnormalities or for emergency situations.

The blood values which require referral to a hematologist or internist are noted in the standard in paragraph (i)(5). The standard specifies that blood abnormalities that persist must be referred "unless the physician has good reason to believe such referral is unnecessary" (paragraph (i)(5)). Examples of conditions that could make a referral unnecessary despite abnormal blood limits are iron or folate deficiency, menorrhagia, or blood loss due to some unrelated medical abnormality.

Symptoms and signs of benzene toxicity can be non-specific. Only a detailed history and appropriate investigative procedures will enable a physician to rule out or confirm conditions that place the employee at increased risk. To assist the examining physician with regard to which laboratory tests are necessary and when to refer an employee to the specialist, OSHA has established the following guidelines.

B. Hematology Guidelines

A minimum battery of tests is to be performed by strictly standardized methods.

1. Red cell, white cell, platelet counts, white blood cell differential, hematacrit and red cell indices must be performed by an accredited laboratory. The normal ranges for the red cell and white cell counts are influenced by altitude, race, and sex, and therefore should be determined by the accredited laboratory in the specific area where the tests are performed.

Either a decline from an absolute normal or an individual's base line to a subnormal value or a rise to a supra-normal value, are indicative of potential toxicity, particularly if all blood parameters decline. The normal total white blood count is approximately 7,200/mm(3) plus or minus 3,000. For cigarette smokers the white count may be higher and the upper range may be 2,000 cells higher than normal for the laboratory. In addition, infection, allergies and some drugs may raise the white cell count. The normal platelet count is approximately 250,000 with a range of 140,000 to 400,000. Counts outside this range should be regarded as possible evidence of benzene toxicity.

Certain abnormalities found through routine screening are of greater significance in the benzene-exposed worker and require prompt consultation with a specialist, namely:

a. Thrombocytopenia.

b. A trend of decreasing white cell, red cell, or platelet indices in an individual over time is more worrisome than an isolated abnormal finding at one test time. The importance of trend highlights the need to compare an individual's test results to baseline and/or previous periodic tests.

c. A constellation or pattern of abnormalities in the different blood indices is of more significance than a single abnormality. A low white count not associated with any abnormalities in other cell indices may be a normal statistical variation, whereas if the low white count is accompanied by decreases in the platelet and/or red cell indices, such a pattern is more likely to be associated with benzene toxicity and merits thorough investigation.

Anemia, leukopenia, macrocytosis or an abnormal differential white blood cell count should alert the physician to further investigate and/or refer the patient if repeat tests confirm the abnormalities. If routine screening detects an abnormality, follow-up tests which may be helpful in establishing the etiology of the abnormality are the peripheral blood smear and the reticulocyte count.

The extreme range of normal for reticulocytes is 0.4 to 2.5 percent of the red cells, the usual range being 0.5 to 1.2 percent of the red cells, but the typical value is in the range of 0.8 to 1.0 percent. A decline in reticulocytes to levels of less than 0.4 percent is to be regarded as possible evidence (unless another specific cause is found) of benzene toxicity requiring accelerated surveillance. An increase in reticulocyte levels to about 2.5 percent may also be consistent with (but is not as characteristic of) benzene toxicity.

2. An important diagnostic test is a careful examination of the peripheral blood smear. As with reticulocyte count the smear should be with fresh uncoagulated blood obtained from a needle tip following venipuncture or from a drop of earlobe blood (capillary blood). If necessary, the smear may, under certain limited conditions, be made from a blood sample anticoagulated with EDTA (but never with oxalate or heparin). When the smear is to be prepared from a specimen of venous blood which has been collected by a commercial Vacutainer type tube containing neutral EDTA, the smear should be made as soon as possible after the venesection. A delay of up to 12 hours is permissible between the drawing of the blood specimen into EDTA and the preparation of the smear if the blood is stored at refrigerator (not freezing) temperature.

3. The minimum mandatory observations to be made from the smear are:

a. The differential white blood cell count. b. Description of abnormalities in the appearance of red cells. c. Description of any abnormalities in the platelets. d. A careful search must be made throughout of every blood smear for immature white cells such as band forms (in more than normal proportion, i.e., over 10 percent of the total differential count), any number of metamyelocytes, myelocytes or myeloblasts. Any nucleate or multinucleated red blood cells should be reported. Large "giant" platelets or fragments of megakaryocytes must be recognized.

An increase in the proportion of band forms among the neutrophilic granulocytes is an abnormality deserving special mention, for it may represent a change which should be considered as an early warning of benzene toxicity in the absence of other causative factors (most commonly infection). Likewise, the appearance of metamyelocytes, in the absence of another probable cause, is to be considered a possible indication of benzene-induced toxicity.

An upward trend in the number of basophils, which normally do not exceed about 2.0 percent of the total white cells, is to be regarded as possible evidence of benzene toxicity. A rise in the eosinophil count is less specific but also may be suspicious of toxicity if the rises above 6.0 percent of the total white count.

The normal range of monocytes is from 2.0 to 8.0 percent of the total white count with an average of about 5.0 percent. About 20 percent of individuals reported to have mild but persisting abnormalities caused by exposure to benzene show a persistent monocytosis. The findings of a monocyte count which persists at more than 10 to 12 percent of the normal white cell count (when the total count is normal) or persistence of an absolute monocyte count in excess of 800/mm(3) should be regarded as a possible sign of benzene-induced toxicity.

A less frequent but more serious indication of benzene toxicity is the finding in the peripheral blood of the so-called "pseudo" (or acquired) Pelger-Huet anomaly. In this anomaly many, or sometimes the majority, of the neutrophilic granulocytes possess two round nuclear segments - less often one or three round segments - rather than three normally elongated segments. When this anomaly is not hereditary, it is often but not invariably predictive of subsequent leukemia. However, only about two percent of patients who ultimately develop acute myelogenous leukemia show the acquired Pelger-Huet anomaly. Other tests that can be administered to investigate blood abnormalities are discussed below; however, such procedures should be undertaken by the hematologist.

An uncommon sign, which cannot be detected from the smear, but can be elicited by a "sucrose water test" of peripheral blood, is transient paroxysmal nocturnal hemoglobinuria (PNH), which may first occur insidiously during a period of established aplastic anemia, and may be followed within one to a few years by the appearance of rapidly fatal acute myelogenous leukemia. Clinical detection of PNH, which occurs in only one or two percent of those destined to have acute myelogenous leukemia, may be difficult; if the "sucrose water test" is positive, the somewhat more definitive Ham test, also known as the acid-serum hemolysis test, may provide confirmation.

e. Individuals documented to have developed acute myelogenous leukemia years after initial exposure to benzene may have progressed through a preliminary phase of hematologic abnormality. In some instances pancytopenia (i.e., a lowering in the counts of all circulating blood cells of bone marrow origin, but not to the extent implied by the term "aplastic anemia") preceded leukemia for many years. Depression of a single blood cell type or platelets may represent a harbinger of aplasia or leukemia. The finding of two or more cytopenias, or pancytopenia in a benzene-exposed individual, must be regarded as highly suspicious of more advanced although still reversible, toxicity. "Pancytopenia" coupled with the appearance of immature cells (myelocytes, myeloblasts, erythroblasts, etc.), with abnormal cells (pseudo Pelger-Huet anomaly, atypical nuclear heterochromatin, etc.), or unexplained elevations of white blood cells must be regarded as evidence of benzene overexposure unless proved otherwise. Many severely aplastic patients manifested the ominous finding of 5-10 percent myeloblasts in the marrow, occasional myeloblasts and myelocytes in the blood and 20-30 percent monocytes. It is evident that isolated cytopenias, pancytopenias, and even aplastic anemias induced by benzene may be reversible and complete recovery has been reported on cessation of exposure. However, since any of these abnormalities is serious, the employee must immediately be removed from any possible exposure to benzene vapor. Certain tests may substantiate the employee's prospects for progression or regression. One such test would be an examination of the bone marrow, but the decision to perform a bone marrow aspiration or needle biopsy is made by the hematologist.

The findings of basophilic stippling in circulating red blood cells (usually found in 1 to 5 percent of red cells following marrow injury), and detection in the bone marrow of what are termed "ringed sideroblasts" must be taken seriously, as they have been noted in recent years to be premonitory signs of subsequent leukemia.

Recently peroxidase-staining of circulating or marrow neutrophil granulocytes, employing benzidine dihydrochloride, have revealed the disappearance of, or diminution in, peroxidase in a sizable proportion of the granulocytes, and this has been reported as an early sign of leukemia. However, relatively few patients have been studied to date. Granulocyte granules are normally strongly peroxidase positive. A steady decline in leukocyte alkaline phosphatase has also been reported as suggestive of early acute leukemia. Exposure to benzene may cause an early rise in serum iron, often but not always associated with a fall in the reticulocyte count. Thus, serial measurements of serum iron levels may provide a means of determining whether or not there is a trend representing sustained suppression of erythropoiesis.

Measurement of serum iron, determination of peroxidase and of alkaline phosphatase activity in peripheral granulocytes can be performed in most pathology laboratories. Peroxidase and alkaline phosphatase staining are usually undertaken when the index of suspicion for leukemia is high.

[58 FR 35627, July 1, 1993]

1915.1028 Appendix D

Sampling and Analytical Methods for Benzene Monitoring and Measurement Procedures.

Measurements taken for the purpose of determining employee exposure to benzene are best taken so that the representative average 8-hour exposure may be determined from a single 8-hour sample or two (2) 4-hour samples. Short-time interval samples (or grab samples) may also be used to determine average exposure level if a minimum of five measurements are taken in a random manner over the 8-hour work shift. Random sampling means that any portion of the work shift has the same change of being sampled as any other. The arithmetic average of all such random samples taken on one work shift is an estimate of an employee's average level of exposure for that work shift. Air samples should be taken in the employee's breathing zone (air that would most nearly represent that inhaled by the employee). Sampling and analysis must be performed with procedures meeting the requirements of the standard.

There are a number of methods available for monitoring employee exposures to benzene. The sampling and analysis may be performed by collection of the benzene vapor or charcoal absorption tubes, with subsequent chemical analysis by gas chromatography. Sampling and analysis may also be performed by portable direct reading instruments, real-time continuous monitoring systems, passive dosimeters or other suitable methods. The employer has the obligation of selecting a monitoring method which meets the accuracy and precision requirements of the standard under his unique field conditions. The standard requires that the method of monitoring must have an accuracy, to a 95 percent confidence level, of not less than plus or minus 25 percent for concentrations of benzene greater than or equal to 0.5 ppm.

The OSHA Laboratory modified NIOSH Method S311 and evaluated it at a benzene air concentration of 1 ppm. A procedure for determining the benzene concentration in bulk material samples was also evaluated. This work, reported in OSHA Laboratory Method No. 12, includes the following two analytical procedures:

I. "OSHA Method 12 for Air Samples"

Analyte: Benzene Matrix: Air Procedure: Adsorption on charcoal, desorption with carbon disulfide, analysis by GC. Detection limit: 0.04 ppm Recommended air volume and sampling rate: 10L to 0.2 L/min.

1. Principle of the Method.

1.1 A known volume of air is drawn through a charcoal tube to trap the organic vapors present.

1.2. The charcoal in the tube is transferred to a small, stoppered vial, and the analyte is desorbed with carbon disulfide.

1.3. An aliquot of the desorbed sample is injected into a gas chromatograph.

1.4 The area of the resulting peak is determined and compared with areas obtained from standards.

2. Advantages and disadvantages of the method.

2.1 The sampling device is small, portable, and involved no liquids.

Interferences are minimal, and most of those which do occur can be eliminated by altering chromatographic conditions. The samples are analyzed by means of a quick, instrumental method.

2.2 The amount of sample which can be taken is limited by the number of milligrams that the tube will hold before overloading. When the sample value obtained for the backup section of the charcoal tube exceeds 25 percent of that found on the front section, the possibility of sample loss exists.

3. Apparatus.

3.1 A calibrated personal sampling pump whose flow can be determined within + or - 5 percent at the recommended flow rate.

3.2. Charcoal tubes: Glass with both ends flame sealed, 7 cm long with a 6-mm O.D. and a 4-mm I.D., containing 2 sections of 20/40 mesh activated charcoal separated by a 2-mm portion of urethane foam. The activated charcoal is prepared from coconut shells and is fired at 600 deg. C prior to packing. The adsorbing section contains 100 mg of charcoal, the back-up section 50 mg. A 3-mm portion of urethane foam is placed between the outlet end of the tube and the back-up section. A plug of silanized glass wool is placed in front of the adsorbing section. The pressure drop across the tube must be less than one inch of mercury at a flow rate of 1 liter per minute.

3.3. Gas chromatograph equipped with a flame ionization detector.

3.4. Column (10-ft X 1/8 -in stainless steel) packed with 80/100 Supelcoport coated with 20 percent SP 2100, 0.1 percent CW 1500.

3.5. An electronic integrator or some other suitable method for measuring peak area.

3.6. Two-milliliter sample vials with Teflon-lined caps.

3.7. Microliter syringes: 10-microliter (10-uL syringe, and other convenient sizes for making standards, 1-uL syringe for sample injections.

3.8. Pipets: 1.0 mL delivery pipets

3.9. Volumetric flasks: convenient sizes for making standard solutions.

4. Reagents.

4.1. Chromatographic quality carbon disulfide (CS(2)). Most commercially available carbon disulfide contains a trace of benzene which must be removed. It can be removed with the following procedure:

Heat under reflux for 2 to 3 hours, 500 mL of carbon disulfide, 10 mL concentrated sulfuric acid, and 5 drops of concentrated nitric acid. The benzene is converted to nitrobenzene. The carbon disulfide layer is removed, dried with anhydrous sodium sulfate, and distilled. The recovered carbon disulfide should be benzene free. (It has recently been determined that benzene can also be removed by passing the carbon disulfide through 13x molecular sieve).

4.2. Benzene, reagent grade.

4.3. p-Cymene, reagent grade, (internal standard).

4.4. Desorbing reagent. The desorbing reagent is prepared by adding 0.05 mL of p-cymene per milliliter of carbon disulfide. (The internal standard offers a convenient means correcting analytical response for slight inconsistencies in the size of sample injections. If the external standard technique is preferred, the internal standard can be eliminated).

4.5. Purified GC grade helium, hydrogen and air.

5. Procedure.

5.1. Cleaning of equipment. All glassware used for the laboratory analysis should be properly cleaned and free of organics which could interfere in the analysis.

5.2. Calibration of personal pumps. Each pump must be calibrated with a representative charcoal tube in the line.

5.3. Collection and shipping of samples.

5.3.1. Immediately before sampling, break the ends of the tube to provide an opening at least one-half the internal diameter of the tube (2 mm).

5.3.2. The smaller section of the charcoal is used as the backup and should be placed nearest the sampling pump.

5.3.3. The charcoal tube should be placed in a vertical position during sampling to minimize channeling through the charcoal.

5.3.4 Air being sampled should not be passed through any hose or tubing before entering the charcoal tube.

5.3.5. A sample size of 10 liters is recommended. Sample at a flow rate of approximately 0.2 liters per minute. The flow rate should be known with an accuracy of at least + or - 5 percent.

5.3.6. The charcoal tubes should be capped with the supplied plastic caps immediately after sampling.

5.3.7. Submit at least one blank tube (a charcoal tube subjected to the same handling procedures, without having any air drawn through it) with each set of samples.

5.3.8. Take necessary shipping and packing precautions to minimize breakage of samples.

5.4. Analysis of samples.

5.4.1. Preparation of samples. In preparation for analysis, each charcoal tube is scored with a file in front of the first section of charcoal and broken open. The glass wool is removed and discarded. The charcoal in the first (larger) section is transferred to a 2-ml vial. The separating section of foam is removed and discarded; the second section is transferred to another capped vial. These two sections are analyzed separately.

5.4.2. Desorption of samples. Prior to analysis, 1.0 mL of desorbing solution is pipetted into each sample container. The desorbing solution consists of 0.05 uL internal standard per mL of carbon disulfide. The sample vials are capped as soon as the solvent is added. Desorption should be done for 30 minutes with occasional shaking.

5.4.3. GC conditions. Typical operating conditions for the gas chromatograph are:

1.30 mL/min (60 psig) helium carrier gas flow. 2.30 mL/min (40 psig) hydrogen gas flow to detector. 3.240 mL/min (40 psig) air flow to detector. 4.150 deg. C injector temperature. 5.250 deg. C detector temperature. 6.100 deg. C column temperature.

5.4.4. Injection size. 1 uL.

5.4.5. Measurement of area. The peak areas are measured by an electronic integrator or some other suitable form of area measurement.

5.4.6. An internal standard procedure is used. The integrator is calibrated to report results in ppm for a 10 liter air sample after correction for desorption efficiency.

5.5. Determination of desorption efficiency.

5.5.1. Importance of determination. The desorption efficiency of a particular compound can vary from one laboratory to another and from one lot of chemical to another. Thus, it is necessary to determine, at least once, the percentage of the specific compound that is removed in the desorption process, provided the same batch of charcoal is used.

5.5.2. Procedure for determining desorption efficiency. The reference portion of the charcoal tube is removed. To the remaining portion, amounts representing 0.5X, 1X, and 2X and (X represents target concentration) based on a 10 L air sample are injected into several tubes at each level. Dilutions of benzene with carbon disulfide are made to allow injection of measurable quantities. These tubes are then allowed to equilibrate at least overnight. Following equilibration they are analyzed following the same procedure as the samples. Desorption efficiency is determined by dividing the amount of benzene found by amount spiked on the tube.

6. Calibration and standards. A series of standards varying in concentration over the range of interest is prepared and analyzed under the same GC conditions that will be used on the samples. A calibration curve is prepared by plotting concentration (ug/mL) versus peak area.

7. Calculations. Benzene air concentration can be calculated from the following equation:

mg/m(3) = (A)(B)/(C)(D) Where: A = ug/mL benzene, obtained from the calibration curve B = desorption volume (1 mL) C = Liters of air sampled D = desorption efficiency

The concentration in mg/m(3) can be converted to ppm (at 25 deg. and 760 mm) with following equation:

ppm = (mg/m(3))(24.46)/(78.11) Where: 24.46 = molar volume of an ideal gas 25 deg. C and 760 mm 78.11 = molecular weight of benzene

8. Backup Data.

8.1 Detection limit-Air Samples. The detection limit for the analytical procedure is 1.28 ng with a coefficient of variation of 0.023 at this level. This would be equivalent to an air concentration of 0.04 ppm for a 10 L air sample. This amount provided a chromatographic peak that could be identifiable in the presence of possible interferences. The detection limit data were obtained by making 1 uL injections of a 1.283 ug/mL standard.

Injection	Area Count

1	655.4
2	617.5D
3	662.0	mean of X = 640.2
4	641.1	SD = 14.9
5	636.4	CV = 0.023
6	629.2

8.2. Pooled coefficient of variation - Air Samples. The pooled coefficient of variation for the analytical procedure was determined by 1 uL replicate injections of analytical standards. The standards were 16.04, 32.08, and 64.16 ug/mL, which are equivalent to 0.5, 1.0, and 2.0 ppm for a 10 L air sample respectively.

Injection	Area Counts
	0.5 ppm	1.0 ppm	2.0 ppm
1	3996.5	8130.2	16481
2	4059.4	8235.6	16493
3	4052.0	8307.9	16535
4	4027.2	8263.2	16609
5	4046.8	8291.1	16552
6	4137.9	8288.8	16618
mean of X =	4053.3	8254.0	16548.3
SD =	47.2	62.5	57.1
CV =	0.0116	0.0076	0.0034
mean of CV = 0.008

8.3. Storage data - Air Samples Samples were generated at 1.03 ppm benzene at 80 percent relative humidity, 22 deg. C, and 643 mm. All samples were taken for 50 minutes at 0.2 L/min. Six samples were analyzed immediately and the rest of the samples were divided into two groups by fifteen samples each. One group was stored at refrigerated temperature of -25 deg. C, and the other group was stored at ambient temperature (approximately 23 deg. C). These samples were analyzed over a period of fifteen days. The results are tabulated below.

PERCENT RECOVERY
Day analyzed	Refrigerated	Ambient
0	97.4 98.7 98.9	97.4 98.7 98.9
0	97.1 100.6 100.9	97.1 100.6 100.9
2	95.8 96.4 95.4	95.4 96.6 96.9
5	93.9 93.7 92.4	92.4 94.3 94.1
9	93.6 95.5 94.6	95.2 95.6 96.6
13	94.3 95.3 93.7	91.0 95.0 94.6
15	96.8 95.8 94.2	92.9 96.3 95.9

8.4. Desorption data. Samples were prepared by injecting liquid benzene onto the A section of charcoal tubes. Samples were prepared that would be equivalent to 0.5, 1.0, and 2.0 ppm for a 10 L air sample.

PERCENT RECOVERY
Sample	0.5	1.0	2.0
	ppm	ppm	ppm
1	99.4	98.8	99.5
2	99.5	98.7	99.7
3	99.2	98.6	99.8
4	99.4	99.1	100.0
5	99.2	99.0	99.7
6	99.8	99.1	99.9
mean of X =	99.4	98.9	99.8
SD =	0.22	0.21	0.18
CV =	0.0022	0.0021	0.0018
mean of X = 99.4

8.5. Carbon disulfide.

Carbon disulfide from a number of sources was analyzed for benzene contamination. The results are given in the following table. The benzene contaminant can be removed with the procedures given in section 4.1.

Sample	ug Benzene/mL	ppm equivalent (for 10 L air sample)
Aldrich Lot 83017	4.20	0.13
Baker Lot 720364	1.01	0.03
Baker Lot 822351	1.01	0.03
Malinkrodt Lot WEMP	1.74	0.05
Malinkrodt Lot WDSJ	5.65	0.18
Malinkrodt Lot WHGA	2.90	0.09
Treated CS(2)

II. "OSHA Laboratory Method No. 12 for Bulk Samples"

Analyte: Benzene. Matrix: Bulk Samples. Procedure: Bulk Samples are analyzed directly by high performance liquid chromatography (HPLC).

Detection limits: 0.01 percent by volume.

1. Principle of the method.

1.1. An aliquot of the bulk sample to be analyzed is injected into a liquid chromatograph.

1.2. The peak area for benzene is determined and compared to areas obtained from standards.

2. Advantages and disadvantages of the method.

2.1. The analytical procedure is quick, sensitive, and reproducible.

2.2. Reanalysis of samples is possible.

2.3. Interferences can be circumvented by proper selection of HPLC parameters.

2.4. Samples must be free of any particulates that may clog the capillary tubing in the liquid chromatograph. This may require distilling the sample or clarifying with a clarification kit.

3. Apparatus.

3.1. Liquid chromatograph equipped with a UV detector.

3.2. HPLC Column that will separate benzene from other components in the bulk sample being analyzed. The column used for validation studies was a Waters uBondapack C18, 30 cm x 3.9 mm.

3.3. A clarification kit to remove any particulates in the bulk if necessary.

3.4. A micro-distillation apparatus to distill any samples if necessary.

3.5. An electronic integrator or some other suitable method of measuring peak areas.

3.6. Microliter syringes - 10 uL syringe and other convenient sizes for making standards. 10 uL syringe for sample injections.

3.7. Volumetric flasks, 5 mL and other convenient sizes for preparing standards and making dilutions.

4. Reagents.

4.1. Benzene, reagent grade.

4.2. HPLC grade water, methyl alcohol, and isopropyl alcohol.

5. Collection and shipment of samples.

5.1. Samples should be transported in glass containers with Teflon-lined caps.

5.2. Samples should not be put in the same container used for air samples.

6. Analysis of samples.

6.1. Sample preparation. If necessary, the samples are distilled or clarified. Samples are analyzed undiluted. If the benzene concentration is out of the working range, suitable dilutions are made with isopropyl alcohol.

6.2. HPLC conditions. The typical operating conditions for the high performance liquid chromatograph are:

1. Mobile phase - Methyl alcohol/water, 50/50 1. Analytical wavelength - 254 nm 3. Injection size - 10 uL 6.3. Measurement of peak area and calibration. Peak areas are measured by an integrator or other suitable means. The integrator is calibrated to report results percent in benzene by volume.

7. Calculations. Since the integrator is programmed to report results in percent benzene by volume in an undiluted sample, the following equation is used:

percent Benzene by Volume = A x B Where: A = percent by volume on report B = Dilution Factor (B = 1 for undiluted sample)

8. Backup Data.

8.1. Detection limit - Bulk Samples. The detection limit for the analytical procedure for bulk samples is 0.88 ug, with a coefficient of variation of 0.019 at this level. This amount provided a chromatographic peak that could be identifiable in the presence of possible interferences. The detection limit date were obtained by making 10 uL injections of a 0.10 percent by volume standard.

Injection	Area Count
1	45386
2	44214
3	43822	mean of X = 44040.1
4	44062	SD = 852.5
6	42724	CV = 0.019

8.2. Pooled coefficient of variation - Bulk Samples. The pooled coefficient of variation for analytical procedure was determined by 50 uL replicate injections of analytical standards. The standards were 0.01, 0.02, 0.04, 0.10, 1.0, and 2.0 percent benzene by volume.

AREA COUNT (PERCENT)
Injection No.	0.01	0.02	0.04	0.10	1.0	2.0
1	45386	84737	166097	448497	4395380	9339150
2	44241	84300	170832	441299	4590800	9484900
3	43822	83835	164160	443719	4593200	9557580
4	44062	84381	164445	444842	4642350	9677060
5	44006	83012	168398	442564	4646430	9766240
6	42724	81957	173002	443975	4646260
mean of X =	44040.1	83703.6	167872	444149	4585767	9564986
SD =	852.5	1042.2	3589.8	2459.1	96839.3	166233
CV =	0.0194	0.0125	0.0213	0.0055	0.0211	0.0174
mean of CV =	0.017

[58 FR 35628, July 1, 1993]

1915.1028 App E Qualitative and Quantitative Fit Testing Procedures.

I. "Fit Test Protocols"

A. The employer shall include the following provisions in the fit test procedures. These provisions apply to both qualitative fit testing (QLFT) and quantitative fit testing (QNFT).

1. The test subject shall be allowed to pick the most comfortable respirator from a selection including respirators of various sizes from different manufacturers. The selection shall include at least three sizes of elastomeric facepieces of the type of respirator that is to be tested, i.e., three sizes of half mask; or three sizes of full facepiece; and units from at least two manufacturers.

2. Prior to the selection process, the test subject shall be shown how to put on a respirator, how it should be positioned on the face, how to set strap tension and how to determine a comfortable fit. A mirror shall be available to assist the subject in evaluating the fit and positioning the respirator. This instruction may not constitute the subject's formal training on respirator use, at it is only a review.

3. The test subject shall be informed that he/she is being asked to select the respirator which provides the most comfortable fit. Each respirator represents a different size and shape, and if fitted and used properly, will provide adequate protection.

4. The test subject shall be instructed to hold each facepiece up to the face and eliminate those which obviously do not give a comfortable fit.

5. The more comfortable facepieces are noted; the most comfortable mask is donned and worn at least five minutes to assess comfort. Assistance in assessing comfort can be given by discussing the points in item 6 below. If the test subject is not familiar with using a particular respirator, the test subject shall be directed to don the mask several times and to adjust the straps each time to become adept at setting proper tension on the straps.

6. Assessment of comfort shall include reviewing the following points with the test subject and allowing the test subject adequate time to determine the comfort of the respirator:

(a) Position of the mask on the nose. (b) Room for eye protection. (c) Room to talk. (d) Position of mask on face and cheeks.

7. The following criteria shall be used to help determine the adequacy of the respirator fit:

(a) Chin properly placed:

(b) Adequate strap tension, not overly tightened;

(d) Respirator of proper size to span distance from nose to chin;

(e) Tendency of respirator to slip;

(f) Self-observation in mirror to evaluate fit and respirator position.

8. The test subject shall conduct the negative and positive pressure fit checks as described below or ANSI Z88.2-1980. Before conducting the negative or positive pressure test, the subject shall be told to seat the mask on the face by moving the head from side-to-side and up and down slowly while taking in a few slow deep breaths. Another facepiece shall be selected and retested if the test subject fails the fit check tests.

(a) "Positive pressure test." Close off the exhalation value and exhale gently onto the facepiece. The face fit is considered satisfactory if a slight positive pressure can be built up inside the facepiece without any evidence of outward leakage of air at the seal. For most respirators this method of leak testing requires the wearer to first remove the exhalation value cover before closing off the exhalation value and then carefully replacing it after the test.

(b) "Negative pressure test." Close off the inlet opening of the canister or cartridge(s) by covering with the palm of the hand(s) or by replacing the filter seal(s), inhale gently so that the facepiece collapses slightly, and hold the breath for ten seconds. If the facepiece remains in its slightly collapsed condition and no inward leakage of air is detected, the tightness of the respirator is considered satisfactory.

9. The test shall not be conducted if there is any hair growth between the skin and the facepiece sealing surface, such as stubble beard growth, beard, or long sideburns which cross the respirator sealing surface. Any type of apparel which interferes with a satisfactory fit shall be altered or removed.

10. If a test subject exhibits difficulty in breathing during the tests, she or he shall be referred to a physician trained in respiratory disease or pulmonary medicine to determine whether the test subject can wear a respirator while performing her or his duties.

11. The test subject shall be given the opportunity to wear the successfully fitted respirator for a period of two weeks. If at any time during this period the respirator becomes uncomfortable, the test subject shall be given the opportunity to select a different facepiece and to be retested.

12. The employer shall certify that a successful fit test has been administered to the employee. The certification shall include the following information:

(a) Name of employee;

(b) Type, brand and size of respirator; and

(c) Date of test. Where QNFT is used, the fit factor, strip chart, or other recording of the results of the test, shall be retained with the certification. The certification shall be maintained until the next fit test is administered.

13. Exercise regimen. Prior to the commencement of the fit test, the test subject shall be given a description of the fit test and the test subject's responsibilities during the test procedure. The description of the process shall include a description of the test exercises that the subject will be performing. The respirator to be tested shall be worn for at least 5 minutes before the start of the fit test.

14. Test Exercises. The test subject shall perform exercises, in the test environment, in the manner described below:

(a) Normal breathing. In a normal standing position, without talking, the subject shall breathe normally.

(b) Deep breathing. In a normal standing position, the subject shall breathe slowly and deeply, taking caution so as to not hyperventilate.

(c) Turning head side to side. Standing in place, the subject shall slowly turn his/her head from side to side between the extreme positions on each side. The head shall be held at each extreme momentarily so the subject can inhale at each side.

(d) Moving head up and down. Standing in place, the subject shall slowly move his/her head up and down. The subject shall be instructed to inhale in the up position (i.e., when looking toward the ceiling).

(e) Talking. The subject shall talk out loud slowly and loud enough so as to be heard clearly by the test conductor. The subject can read from a prepared text such as the Rainbow Passage, count backward from 100, or recite a memorized poem or song.

(f) Grimace. The test subject shall grimace by smiling or frowning. (g) Bending over. The test subject shall bend at the waist as if he/she were to touch his/her toes. Jogging in place shall be substituted for this exercise in those test environments such as shroud type QNFT units which prohibit bending at the waist.

(h) Normal breathing. Same as exercise 1. Each test exercise shall be performed for one minute except for the grimace exercise which shall be performed for 15 seconds.

The test subject shall be questioned by the test conductor regarding the comfort of the respirator upon completion of the protocol. If it has become uncomfortable, another model of respirator shall be tried.

B. Qualitative Fit Test (QLFT) Protocols. 1. "General." (a) The employer shall assign specific individuals who shall assume full responsibility for implementing the respirator qualitative fit test program.

(b) The employer shall ensure that persons administering QLFT are able to prepare test solutions, calibrate equipment and perform tests properly, recognize invalid tests, and assure that test equipment is in proper working order.

(c) The employer shall assure that QLFT equipment is kept clean and well maintained so as to operate at the parameters for which it was designed.

2. "Isoamyl Acetate Protocol."

(a) Odor threshold screening. The odor threshold screening test, performed without wearing a respirator, is intended to determine if the individual tested can detect the odor of isoamyl acetate.

(1) Three 1-liter glass jars with metal lids are required.

(2) Odor free water (e.g. distilled or spring water) at approximately 25 degrees C shall be used for the solutions.

(3) The isoamyl acetate (IAA) (also known as isopentyl acetate) stock solution is prepared by adding 1 cc of pure IAA to 800 cc of odor free water in a 1 liter jar and shaking for 30 seconds. A new solution shall be prepared at least weekly.

(4) The screening test shall be conducted in a room separate from the room used for actual fit testing. The two rooms shall be well ventilated but shall not be connected to the same recirculating ventilation system.

(5) The odor test solution is prepared in a second jar by placing 0.4 cc of the stock solution into 500 cc of odor free water using a clean dropper or pipette. The solution shall be shaken for 30 seconds and allowed to stand for two to three minutes so that the IAA concentration above the liquid may reach equilibrium. This solution shall be used for only one day.

(6) A test blank shall be prepared in a third jar by adding 500 cc of odor free water.

(7) The odor test and test blank jars shall be labeled 1 and 2 for jar identification. Labels shall be placed on the lids so they can be periodically peeled, dried off and switched to maintain the integrity of the test.

(8) The following instruction shall be typed on a card and placed on the table in front of the two test jars (i.e., 1 and 2): "The purpose of this test is to determine if you can smell banana oil at a low concentration. The two bottles in front of you contain water. One of these bottles also contains a small amount of banana oil. Be sure the covers are on tight, then shake each bottle for two seconds. Unscrew the lid of each bottle, one at a time, and sniff at the mouth of the bottle. Indicate to the test conductor which bottle contains banana oil."

(9) The mixtures used in the IAA odor detection test shall be prepared in an area separate from where the test is performed, in order to prevent olfactory fatigue in the subject.

(10) If the test subject is unable to correctly identify the jar containing the odor test solution, the IAA qualitative fit test shall not be performed.

(11) If the test subject correctly identifies the jar containing the odor test solution, the test subject may proceed to respirator selection and fit testing.

(b) Isoamyl acetate fit test. (1) The fit test chamber shall be similar to a clear 55-gallon drum liner suspended inverted over a 2-foot diameter frame so that the top of the chamber is about 6 inches (15.24 cm) above the test subject's head. The inside top center of the chamber shall have a small hook attached.

(2) Each respirator used for the fitting and fit testing shall be equipped with organic vapor cartridges or offer protection against organic vapors. The cartridges or masks shall be changed at least weekly.

(3) After selecting, donning, and properly adjusting a respirator, the test subject shall wear it to the fit testing room. This room shall be separate from the room used for odor threshold screening and respirator selection, and shall be well ventilated, as by an exhaust fan or lab hood, to prevent general room contamination.

(4) A copy of the test exercises and any prepared text from which the subject is to read shall be taped to the inside of the test chamber.

(5) Upon entering the test chamber, the test subject shall be given a 6-inch by 5-inch (15.24 X 12.7 cm) piece of paper towel, or other porous, absorbent, single-ply material, folded in half and wetted with 0.75 cc of pure IAA. The test subject shall hand the wet towel on the hook at the top of the chamber.

(6) Allow two minutes for the IAA test concentration to stabilize before starting the fit test exercises. This would be an appropriate time to talk with the test subject; to explain the fit test, the importance of his/her cooperation, and the purpose for the head exercises; or to demonstrate some of the exercises.

(7) If at any time during the test, the subject detects the banana like odor of IAA, the test has failed. The subject shall quickly exit from the test chamber and leave the test area to avoid olfactory fatigue.

(8) If the test has failed, the subject shall return to the selection room and remove the respirator, repeat the odor sensitivity test, select and put on another respirator, return to the test chamber and again begin the procedure described in (1) through (7) above. The process continues until a respirator that fits well has been found. Should the odor sensitivity test be failed, the subject shall wait about 5 minutes before retesting. Odor sensitivity will usually have returned by this time.

(9) When a respirator is found that passes the test, its efficiency shall be demonstrated for the subject by having the subject break the face seal and take a breath before existing the chamber.

(10) When the test subject leaves the chamber, the subject shall remove the saturated towel and return it to the person conducting the test. To keep the test area from becoming contaminated, the used towels shall be kept in a self sealing bag so there is no significant IAA concentration build-up in the test chamber during subsequent tests.

3. "Saccharin Solution Aerosol Protocol."

The saccharin solution aerosol QLFT protocol is the only currently available, validated test protocol for use with particulate disposable dust respirators not equipped with high-efficiency filters. The entire screening and testing procedure shall be explained to the test subject prior to the conduct of the screening test.

(a) Taste threshold screening. The saccharin taste threshold screening, performed without wearing a respirator, is intended to determine whether the individual being tested can detect the taste of saccharin.

(1) Threshold screening as well as fit testing subjects shall wear an enclosure about the head and shoulders that is approximately 12 inches (30.48 cm) in diameter by 14 inches (35.56 cm) tall with at least the front portion clear and that allows free movements of the head when a respirator is worn. An enclosure substantially similar to the 3M hood assembly, parts number FT 14 and number FT 15 combined, is adequate.

(2) The test enclosure shall have a 3/4-inch (1.905 cm) hole in front of the test subject's nose and mouth area to accommodate the nebulizer nozzle.

(3) The test subject shall don the test enclosure. Throughout the threshold screening test, the test subject shall breathe through his/her wide open mouth with tongue extended.

(4) Using a DeVilbiss Model 40 Inhalation Medication Nebulizer the test conductor shall spray the "threshold check solution" into the enclosure. This nebulizer shall be clearly marked to distinguish it from the fit test solution nebulizer.

(5) The "threshold check solution" consists of 0.83 grams of sodium saccharin USP in 1 cc of warm water. It can be prepared by putting 1 cc of the fit test solution (see (b)(5) below) in 100 cc of distilled water.

(6) To produce the aerosol, the nebulizer bulb is firmly squeezed so that it collapses completely, then released and allowed to fully expand.

(7) Ten squeezes are repeated rapidly and then the test subject is asked whether the saccharin can be tasted.

(8) If the first response is negative, ten more squeezes are repeated rapidly and the test subject is again asked whether the saccharin is tasted.

(9) If the second response is negative, ten more squeezes are repeated rapidly and the test subject is again asked whether the saccharin is tasted.

(10) The test conductor will take note of the number of squeezes required to solicit a taste response.

(11) If the saccharin is not tasted after 30 squeezes (step 10), the test subject may not perform the saccharin fit test.

(12) If a taste response is elicited, the test subject shall be asked to take note of the taste for reference in the fit test.

(13) Correct use of the nebulizer means that approximately 1 cc of liquid is used at a time in the nebulizer body.

(14) The nebulizer shall be thoroughly rinsed in water, shaken dry, and refilled at least each morning and afternoon or at least every four hours.

(b) Saccharin solution aerosol fit test procedure. (1) The test subject may not eat, drink (except plain water), or chew gum for 15 minutes before the test.

(2) The fit test uses the same enclosure described in (a) above.

(3) The test subject shall don the enclosure while wearing the respirator selected in section (a) above. The respirator shall be properly adjusted and equipped with a particulate filter(s).

(4) A second DeVilbiss Model 40 Inhalation Medication Nebulizer is used to spray the fit test solution into the enclosure. This nebulizer shall be clearly marked to distinguish it from the screening test solution nebulizer.

(5) The fit test solution is prepared by adding 83 grams of sodium saccharin to 100 cc of warm water.

(6) As before, the test subject shall breathe through the open mouth with tongue extended.

(7) The nebulizer is inserted into the hole in the front of the enclosure and the fit test solution is sprayed into the enclosure using the same number of squeezes required to elicit a taste response in the screening test.

(8) After generating the aerosol the test subject shall be instructed to perform the exercises in section I. A. 14 above.

(9) Every 30 seconds the aerosol concentration shall be replenished using one half the number of squeezes as initially.

(10) The test subject shall indicate to the test conductor if at any time during the fit test the taste of saccharin is detected.

(11) If the taste of saccharin is detected, the fit is deemed unsatisfactory and a different respirator shall be tried.

4. "Irritant Fume Protocol."

(a) The respirator to be tested shall be equipped with high-efficiency particulate air (HEPA) filters.

(b) The test subject shall be allowed to smell a weak concentration of the irritant smoke before the respirator is donned to become familiar with its characteristic odor.

(c) Break both ends of a ventilation smoke tube containing stannic oxychloride, such as the MSA part No. 5645, or equivalent. Attach one end of the smoke tube to a low flow air pump set to deliver 200 milliliters per minute.

(d) Advise the test subject that the smoke can be irritating to the eyes and instruct the subject to keep his/her eyes closed while the test is performed.

(e) The test conductor shall direct the stream of irritant smoke from the smoke tube towards the face seal area of the test subject. He/She shall begin at least 12 inches (30.48 cm) from the facepiece and gradually move to within one inch (2.54 cm), moving around the whole perimeter of the mask.

(f) The exercises identified in section I. A. 14 above shall be performed by the test subject while the respirator seal is being challenged by the smoke.

(g) Each test subject passing the smoke test without evidence of a response shall be given a sensitivity check of the smoke from the same tube once the respirator has been removed to determine whether he/she reacts to the smoke. Failure to evoke a response shall void the fit test.

(h) The fit test shall be performed in a location with exhaust ventilation sufficient to prevent general contamination of the testing area by the test agent.

C. Quantitative Fit Test (QNFT) Protocol. 1. "General." (a) The employer shall assign specific individuals who shall assume full responsibility for implementing the respirator quantitative fit test program.

(b) The employer shall ensure that persons administering QNFT are able to calibrate equipment and perform tests properly, recognize invalid tests, calculate fit factors properly and assure that test equipment is in proper working order.

(c) The employer shall assure that QNFT equipment is kept clean and well maintained so as to operate at the parameters for which it was designed.

2. "Definitions."

(a) Quantitative fit test. The test is performed in a test chamber. The normal air-purifying element of the respirator is replaced by a high-efficiency particulate air (HEPA) filter in the case of particulate QNFT aerosols or a sorbent offering contaminant penetration protection equivalent to high-efficiency filters where the QNFT test agent is a gas or vapor.

(b) Challenge agent means the aerosol, gas or vapor introduced into a test chamber so that its concentration inside and outside the respirator may be measured.

(d) Normal standing position means standing erect and straight with arms down along the sides and looking straight ahead.

(e) Maximum peak penetration method means the method of determining test agent penetration in the respirator as determined by strip chart recordings of the test. The highest peak penetration for a given exercise is taken to be representative of average penetration into the respirator for that exercise.

(f) Average peak penetration method means the method of determining test agent penetration into the respirator utilizing a strip chart recorder, integrator, or computer. The agent penetration is determined by an average of the peak heights on the graph or by computer integration, for each exercise except the grimace exercise. Integrators or computers which calculate the actual test agent penetration into the respirator for each exercise will also be considered to meet the requirements of the average peak penetration method.

(g) "Fit Factor" means the ration of challenge agent concentration outside with respect to the inside of a respirator inlet covering (facepiece or enclosure).

3. "Apparatus."

(a) Instrumentation. Aerosol generation, dilution, and measurement systems using corn oil or sodium chloride as test aerosols shall be used for quantitatives fit testing.

(b) Test chamber. The test chamber shall be large enough to permit all test subjects to perform freely all required exercises without disturbing the challenge agent concentration or the measurement apparatus. The test chamber shall be equipped and constructed so that the challenge agent is effectively isolated from the ambient air, yet uniform in concentration throughout the chamber.

(c) When testing air-purifying respirators, the normal filter or cartridge element shall be replaced with a high-efficiency particulate filter supplied by the same manufacturer.

(d) The sampling instrument shall be selected so that a strip chart record may be made of the test showing the rise and fall of the challenge agent concentration with each inspiration and expiration at fit factors of at least 2,000. Integrators or computers which integrate the amount of test agent penetration leakage into the respirator for each exercise may be used provided a record of the readings is made.

(e) The combination of substitute air-purifying elements, challenge agent and challenge agent concentration in the test chamber shall be such that the test subject is not exposed in excess of an established exposure limit for the challenge agent at any time during the testing process.

(f) The sampling port on the test specimen respirator shall be placed and constructed so that no leakage occurs around the port (e.g. where the respirator is probed), a free air flow is allowed into the sampling line at all times and so that there is no interference with the fit or performance of the respirator.

(g) The test chamber and test set up shall permit the person administering the test to observe the test subject inside the chamber during the test.

(h) The equipment generating the challenge atmosphere shall maintain the concentration of challenge agent inside the test chamber constant to within a 10 percent variation for the duration of the test.

(i) The time lag (interval between an event and the recording of the event on the strip chart or computer or integrator) shall be kept to a minimum. There shall be a clear association between the occurrence of an event inside the test chamber and its being recorded.

(j) The sampling line tubing for the test chamber atmosphere and for the respirator sampling port shall be of equal diameter and of the same material. The length of the two lines shall be equal.

(k) The exhaust flow from the test chamber shall pass through a high-efficiency filter before release.

(l) When sodium chloride aerosol is used, the relative humidity inside the test chamber shall not exceed 50 percent.

(m) The limitations of instrument detection shall be taken into account when determining the fit factor.

(n) Test respirators shall be maintained in proper working order and inspected for deficiencies such as cracks, missing valves and gaskets, etc.

4. "Procedural Requirements."

(a) When performing the initial positive or negative pressure test the sampling line shall be crimped closed in order to avoid air pressure leakage during either of these tests.

(b) An abbreviated screening isoamyl acetate test or irritant fume test may be utilized in order to quickly identify poor fitting respirators which passed the positive and/or negative pressure test and thus reduce the amount of QNFT time. When performing a screening isoamyl acetate test, combination high-efficiency organic vapor cartridges/canisters shall be used.

(c) A reasonably stable challenge agent concentration shall be measured in the test chamber prior to testing. For canopy or shower curtain type of test units the determination of the challenge agent stability may be established after the test subject has entered the test environment.

(d) Immediately after the subject enters the test chamber, the challenge agent concentration inside the respirator shall be measured to ensure that the peak penetration does not exceed 5 percent for a half mask or 1 percent for a full facepiece respirator.

(e) A stable challenge concentration shall be obtained prior to the actual start of testing.

(f) Respirator restraining straps shall not be overtightened for testing. The straps shall be adjusted by the wearer without assistance from other persons to give a reasonable comfortable fit typical of normal use.

(g) The test shall be terminated whenever any single peak penetration exceeds 5 percent for half masks and 1 percent for full facepiece respirators. The test subject shall be refitted and retested. If two of the three required tests are terminated, the fit shall be deemed inadequate.

(h) In order to successfully complete a QNFT, three successful fit tests are required. The results of each of the three independent fit tests must exceed the minimum fit factor needed for the class of respirator (e.g. half mask respirator, full facepiece respirator).

(i) Calculation of fit factors. (1) The fit factor shall be determined for the quantitative fit test by taking the ratio of the average chamber concentration to the concentration inside the respirator.

(2) The average test chamber concentration is the arithmetic average of the test chamber concentration at the beginning and of the end of the test.

(3) The concentration of the challenge agent inside the respirator shall be determined by one of the following methods:

(i) Average peak concentration.

(ii) Maximum peak concentration.

(iii) Integration by calculation of the area under the individual peak for each exercise. This includes computerized integration.

(j) Interpretation of test results. The fit factor established by the quantitative fit testing shall be the lowest of the three fit factor values calculated from the three required fit tests.

(k) The test subject shall not be permitted to wear a half mask, or full facepiece respirator unless a minimum fit factor equivalent to at least 10 times the hazardous exposure level is obtained.

(l) Filters used for quantitative fit testing shall be replaced at least weekly, or whenever increased breathing resistance is encountered, or when the test agent has altered the integrity of the filter media. Organic vapor cartridges/canisters shall be replaced daily (when used) or sooner if there is any indication of breakthrough by a test agent.

[58 FR 35631, July 1, 1993]

1915.1030 Bloodborne pathogens

(a) "Scope and Application." This section applies to all occupational exposure to blood or other potentially infectious materials as defined by paragraph (b) of this section.

(b) "Definitions." For purposes of this section, the following shall apply:

"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, or designated representative.

"Blood" means human blood, human blood components, and products made from human blood.

"Bloodborne Pathogens" means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV).

"Clinical Laboratory" means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials.

"Contaminated" means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.

"Contaminated Laundry" means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps.

"Contaminated Sharps" means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires.

"Decontamination" means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.

"Director" means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designated representative.

"Engineering Controls" means controls (e.g., sharps disposal containers, self-sheathing needles) that isolate or remove the bloodborne pathogens hazard from the workplace.

"Exposure Incident" means a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties.

"Handwashing Facilities" means a facility providing an adequate supply of running potable water, soap and single use towels or hot air drying machines.

"Licensed Healthcare Professional" is a person whose legally permitted scope of practice allows him or her to independently perform the activities required by paragraph (f) Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up.

"HBV" means hepatitis B virus.

"HIV" means human immunodeficiency virus. "Occupational Exposure" means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.

"Other Potentially Infectious Materials" means:

(1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids;

(2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and

(3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

"Parenteral" means piercing mucous membranes or the skin barrier through such events as needlesticks, human bites, cuts, and abrasions.

"Personal Protective Equipment" is specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.

"Production Facility" means a facility engaged in industrial-scale, large-volume or high concentration production of HIV or HBV.

"Regulated Waste" means liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials.

"Research Laboratory" means a laboratory producing or using research-laboratory-scale amounts of HIV or HBV. Research laboratories may produce high concentrations of HIV or HBV but not in the volume found in production facilities.

"Source Individual" means any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Examples include, but are not limited to, hospital and clinic patients; clients in institutions for the developmentally disabled; trauma victims; clients of drug and alcohol treatment facilities; residents of hospices and nursing homes; human remains; and individuals who donate or sell blood or blood components.

"Sterilize" means the use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores.

"Universal Precautions" is an approach to infection control. According to the concept of Universal Precautions, all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens.

"Work Practice Controls" means controls that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique).

(c) "Exposure Control." (1) "Exposure Control Plan." (i) Each employer having an employee(s) with occupational exposure as defined by paragraph (b) of this section shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure.

(ii) The Exposure Control Plan shall contain at least the following elements:

(A) The exposure determination required by paragraph (c)(2), (B) The schedule and method of implementation for paragraphs (d) Methods of Compliance, (e) HIV and HBV Research Laboratories and Production Facilities, (f) Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up, (g) Communication of Hazards to Employees, and (h) Recordkeeping, of this standard, and (C) The procedure for the evaluation of circumstances surrounding exposure incidents as required by paragraph (f)(3)(i) of this standard.

(iii) Each employer shall ensure that a copy of the Exposure Control Plan is accessible to employees in accordance with 29 CFR 1915.1120(e).

(iv) The Exposure Control Plan shall be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupational exposure.

(v) The Exposure Control Plan shall be made available to the Assistant Secretary and the Director upon request for examination and copying.

(2) "Exposure determination." (i) Each employer who has an employee(s) with occupational exposure as defined by paragraph (b) of this section shall prepare an exposure determination. This exposure determination shall contain the following:

(A) A list of all job classifications in which all employees in those job classifications have occupational exposure;

(B) A list of job classifications in which some employees have occupational exposure, and

(C) A list of all tasks and procedures or groups of closely related task and procedures in which occupational exposure occurs and that are performed by employees in job classifications listed in accordance with the provisions of paragraph (c)(2)(i)(B) of this standard.

(ii) This exposure determination shall be made without regard to the use of personal protective equipment.

(d) "Methods of Compliance." (1) "General." Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Under circumstances in which differentiation between body fluid types is difficult or impossible, all body fluids shall be considered potentially infectious materials.

(2) "Engineering and work practice controls." (i) Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall also be used.

(ii) Engineering controls shall be examined and maintained or replaced on a regular schedule to ensure their effectiveness.

(iii) Employers shall provide handwashing facilities which are readily accessible to employees.

(iv) When provision of handwashing facilities is not feasible, the employer shall provide either an appropriate antiseptic hand cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes. When antiseptic hand cleansers or towelettes are used, hands shall be washed with soap and running water as soon as feasible.

(v) Employers shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment.

(vi) Employers shall ensure that employees wash hands and any other skin with soap and water, or flush mucous membranes with water immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials.

(vii) Contaminated needles and other contaminated sharps shall not be bent, recapped, or removed except as noted in paragraphs (d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of contaminated needles is prohibited.

(A) Contaminated needles and other contaminated sharps shall not be bent, recapped or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure.

(B) Such bending, recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique.

(viii) Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be:

(A) Puncture resistant;

(B) Labeled or color-coded in accordance with this standard;

(D) In accordance with the requirements set forth in paragraph (d)(4)(ii)(E) for reusable sharps.

(ix) Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure.

(x) Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present.

(xi) All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances.

(xii) Mouth pipetting/suctioning of blood or other potentially infectious materials is prohibited.

(xiii) Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping.

(A) The container for storage, transport, or shipping shall be labeled or color-coded according to paragraph (g)(1)(i) and closed prior to being stored, transported, or shipped. When a facility utilizes Universal Precautions in the handling of all specimens, the labeling/color-coding of specimens is not necessary provided containers are recognizable as containing specimens. This exemption only applies while such specimens/containers remain within the facility. Labeling or color-coding in accordance with paragraph (g)(1)(i) is required when such specimens/containers leave the facility.

(B) If outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping and is labeled or color-coded according to the requirements of this standard.

(C) If the specimen could puncture the primary container, the primary container shall be placed within a secondary container which is puncture-resistant in addition to the above characteristics.

(xiv) Equipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible.

(A) A readily observable label in accordance with paragraph (g)(1)(i)(H) shall be attached to the equipment stating which portions remain contaminated.

(B) The employer shall ensure that this information is conveyed to all affected employees, the servicing representative, and/or the manufacturer, as appropriate, prior to handling, servicing, or shipping so that appropriate precautions will be taken.

(3) "Personal Protective Equipment." - (i) "Provision." When there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.

(ii) "Use." The employer shall ensure that the employee uses appropriate personal protective equipment unless the employer shows that the employee temporarily and briefly declined to use personal protective equipment when, under rare and extraordinary circumstances, it was the employee's professional judgment that in the specific instance its use would have prevented the delivery of health care or public safety services or would have posed an increased hazard to the safety of the worker or co-worker. When the employee makes this judgement, the circumstances shall be investigated and documented in order to determine whether changes can be instituted to prevent such occurrences in the future.

(iii) "Accessibility." The employer shall ensure that appropriate personal protective equipment in the appropriate sizes is readily accessible at the worksite or is issued to employees. Hypoallergenic gloves, glove liners, powderless gloves, or other similar alternatives shall be readily accessible to those employees who are allergic to the gloves normally provided.

(iv) "Cleaning, Laundering, and Disposal." The employer shall clean, launder, and dispose of personal protective equipment required by paragraphs (d) and (e) of this standard, at no cost to the employee.

(v) "Repair and Replacement." The employer shall repair or replace personal protective equipment as needed to maintain its effectiveness, at no cost to the employee.

(vi) If a garment(s) is penetrated by blood or other potentially infectious materials, the garment(s) shall be removed immediately or as soon as feasible.

(vii) All personal protective equipment shall be removed prior to leaving the work area.

(viii) When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination or disposal.

(ix) "Gloves." Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin; when performing vascular access procedures except as specified in paragraph (d)(3)(ix)(D); and when handling or touching contaminated items or surfaces.

(A) Disposable (single use) gloves such as surgical or examination gloves, shall be replaced as soon as practical when contaminated or as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised.

(B) Disposable (single use) gloves shall not be washed or decontaminated for re-use.

(C) Utility gloves may be decontaminated for re-use if the integrity of the glove is not compromised. However, they must be discarded if they are cracked, peeling, torn, punctured, or exhibit other signs of deterioration or when their ability to function as a barrier is compromised.

(D) If an employer in a volunteer blood donation center judges that routine gloving for all phlebotomies is not necessary then the employer shall:

(1) Periodically reevaluate this policy;

(2) Make gloves available to all employees who wish to use them for phlebotomy;

(3) Not discourage the use of gloves for phlebotomy; and

(4) Require that gloves be used for phlebotomy in the following circumstances:

[i] When the employee has cuts, scratches, or other breaks in his or her skin;

[ii] When the employee judges that hand contamination with blood may occur, for example, when performing phlebotomy on an uncooperative source individual; and

[iii] When the employee is receiving training in phlebotomy. (x) "Masks, Eye Protection, and Face Shields." Masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated.

(xi) "Gowns, Aprons, and Other Protective Body Clothing." Appropriate protective clothing such as, but not limited to, gowns, aprons, lab coats, clinic jackets, or similar outer garments shall be worn in occupational exposure situations. The type and characteristics will depend upon the task and degree of exposure anticipated.

(xii) Surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipated (e.g., autopsies, orthopaedic surgery).

(4) "Housekeeping." - (i) "General." Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area.

(ii) All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials.

(A) Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning.

(B) Protective coverings, such as plastic wrap, aluminum foil, or imperviously-backed absorbent paper used to cover equipment and environmental surfaces, shall be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the workshift if they may have become contaminated during the shift.

(C) All bins, pails, cans, and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials shall be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination.

(D) Broken glassware which may be contaminated shall not be picked up directly with the hands. It shall be cleaned up using mechanical means, such as a brush and dust pan, tongs, or forceps.

(E) Reusable sharps that are contaminated with blood or other potentially infectious materials shall not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed.

(iii) "Regulated Waste." (A) "Contaminated Sharps Discarding and Containment." (1) Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are:

[i] Closable;

[ii] Puncture resistant;

[iii] Leakproof on sides and bottom; and

[iv] Labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard.

(2) During use, containers for contaminated sharps shall be:

[i] Easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found (e.g., laundries);

[ii] Maintained upright throughout use; and

[iii] Replaced routinely and not be allowed to overfill.

(3) When moving containers of contaminated sharps from the area of use, the containers shall be:

[i] Closed immediately prior to removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping;

[ii] Placed in a secondary container if leakage is possible. The second container shall be:

[A] Closable;

[B] Constructed to contain all contents and prevent leakage during handling, storage, transport, or shipping; and

[C] Labeled or color-coded according to paragraph (g)(1)(i) of this standard.

(4) Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury.

(B) "Other Regulated Waste Containment." (1) Regulated waste shall be placed in containers which are:

[i] Closable;

[ii] Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping;

[iii] Labeled or color-coded in accordance with paragraph (g)(1)(i) this standard; and

[iv] Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping.

(2) If outside contamination of the regulated waste container occurs, it shall be placed in a second container. The second container shall be:

[i] Closable;

[ii] Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping;

[iii] Labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard; and

[iv] Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping.

(C) Disposal of all regulated waste shall be in accordance with applicable regulations of the United States, States and Territories, and political subdivisions of States and Territories.

(iv) "Laundry." (A) Contaminated laundry shall be handled as little as possible with a minimum of agitation.

(1) Contaminated laundry shall be bagged or containerized at the location where it was used and shall not be sorted or rinsed in the location of use.

(2) Contaminated laundry shall be placed and transported in bags or containers labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard. When a facility utilizes Universal Precautions in the handling of all soiled laundry, alternative labeling or color-coding is sufficient if it permits all employees to recognize the containers as requiring compliance with Universal Precautions.

(3) Whenever contaminated laundry is wet and presents a reasonable likelihood of soak-through of or leakage from the bag or container, the laundry shall be placed and transported in bags or containers which prevent soak-through and/or leakage of fluids to the exterior.

(B) The employer shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment.

(C) When a facility ships contaminated laundry off-site to a second facility which does not utilize Universal Precautions in the handling of all laundry, the facility generating the contaminated laundry must place such laundry in bags or containers which are labeled or color-coded in accordance with paragraph (g)(1)(i).

(e) "HIV and HBV Research Laboratories and Production Facilities."

(1) This paragraph applies to research laboratories and production facilities engaged in the culture, production, concentration, experimentation, and manipulation of HIV and HBV. It does not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues, or organs. These requirements apply in addition to the other requirements of the standard.

(2) Research laboratories and production facilities shall meet the following criteria:

(i) "Standard microbiological practices." All regulated waste shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens.

(ii) "Special practices." (A) Laboratory doors shall be kept closed when work involving HIV or HBV is in progress.

(B) Contaminated materials that are to be decontaminated at a site away from the work area shall be placed in a durable, leakproof, labeled or color-coded container that is closed before being removed from the work area.

(C) Access to the work area shall be limited to authorized persons. Written policies and procedures shall be established whereby only persons who have been advised of the potential biohazard, who meet any specific entry requirements, and who comply with all entry and exit procedures shall be allowed to enter the work areas and animal rooms.

(D) When other potentially infectious materials or infected animals are present in the work area or containment module, a hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors. The hazard warning sign shall comply with paragraph (g)(1)(ii) of this standard.

(E) All activities involving other potentially infectious materials shall be conducted in biological safety cabinets or other physical-containment devices within the containment module. No work with these other potentially infectious materials shall be conducted on the open bench.

(F) Laboratory coats, gowns, smocks, uniforms, or other appropriate protective clothing shall be used in the work area and animal rooms. Protective clothing shall not be worn outside of the work area and shall be decontaminated before being laundered.

(G) Special care shall be taken to avoid skin contact with other potentially infectious materials. Gloves shall be worn when handling infected animals and when making hand contact with other potentially infectious materials is unavoidable.

(H) Before disposal all waste from work areas and from animal rooms shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens.

(I) Vacuum lines shall be protected with liquid disinfectant traps and high-efficiency particulate air (HEPA) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained or replaced as necessary.

(J) Hypodermic needles and syringes shall be used only for parenteral injection and aspiration of fluids from laboratory animals and diaphragm bottles. Only needle-locking syringes or disposable syringe-needle units (i.e., the needle is integral to the syringe) shall be used for the injection or aspiration of other potentially infectious materials. Extreme caution shall be used when handling needles and syringes. A needle shall not be bent, sheared, replaced in the sheath or guard, or removed from the syringe following use. The needle and syringe shall be promptly placed in a puncture-resistant container and autoclaved or decontaminated before reuse or disposal.

(K) All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials.

(L) A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director or other responsible person.

(M) A biosafety manual shall be prepared or adopted and periodically reviewed and updated at least annually or more often if necessary. Personnel shall be advised of potential hazards, shall be required to read instructions on practices and procedures, and shall be required to follow them.

(iii) "Containment equipment." (A) Certified biological safety cabinets (Class I, II, or III) or other appropriate combinations of personal protection or physical containment devices, such as special protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals, shall be used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes, spills, or aerosols.

(B) Biological safety cabinets shall be certified when installed, whenever they are moved and at least annually.

(3) HIV and HBV research laboratories shall meet the following criteria:

(i) Each laboratory shall contain a facility for hand washing and an eye wash facility which is readily available within the work area.

(ii) An autoclave for decontamination of regulated waste shall be available.

(4) HIV and HBV production facilities shall meet the following criteria:

(i) The work areas shall be separated from areas that are open to unrestricted traffic flow within the building. Passage through two sets of doors shall be the basic requirement for entry into the work area from access corridors or other contiguous areas. Physical separation of the high-containment work area from access corridors or other areas or activities may also be provided by a double-doored clothes-change room (showers may be included), airlock, or other access facility that requires passing through two sets of doors before entering the work area.

(ii) The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination.

(iii) Each work area shall contain a sink for washing hands and a readily available eye wash facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area.

(iv) Access doors to the work area or containment module shall be self-closing.

(v) An autoclave for decontamination of regulated waste shall be available within or as near as possible to the work area.

(vi) A ducted exhaust-air ventilation system shall be provided. This system shall create directional airflow that draws air into the work area through the entry area. The exhaust air shall not be recirculated to any other area of the building, shall be discharged to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified (i.e., into the work area).

(5) "Training requirements." Additional training requirements for employees in HIV and HBV research laboratories and HIV and HBV production facilities are specified in paragraph (g)(2)(ix).

(f) "Hepatitis B vaccination and post-exposure evaluation and follow-up." - (1) "General." (i) The employer shall make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and post-exposure evaluation and follow-up to all employees who have had an exposure incident.

(ii) The employer shall ensure that all medical evaluations and procedures including the hepatitis B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis, are:

(A) Made available at no cost to the employee;

(B) Made available to the employee at a reasonable time and place;

(C) Performed by or under the supervision of a licensed physician or by or under the supervision of another licensed healthcare professional; and (D) Provided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place, except as specified by this paragraph (f).

(iii) The employer shall ensure that all laboratory tests are conducted by an accredited laboratory at no cost to the employee.

(2) "Hepatitis B vaccination." (i) Hepatitis B vaccination shall be made available after the employee has received the training required in paragraph (g)(2)(vii)(I) and within 10 working days of initial assignment to all employees who have occupational exposure unless the employee has previously received the complete hepatitis B vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons.

(ii) The employer shall not make participation in a prescreening program a prerequisite for receiving hepatitis B vaccination.

(iii) If the employee initially declines hepatitis B vaccination but at a later date while still covered under the standard decides to accept the vaccination, the employer shall make available hepatitis B vaccination at that time.

(iv) The employer shall assure that employees who decline to accept hepatitis B vaccination offered by the employer sign the statement in Appendix A.

(v) If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health Service at a future date, such booster dose(s) shall be made available in accordance with section (f)(1)(ii).

(3) "Post-exposure evaluation and follow-up." Following a report of an exposure incident, the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up, including at least the following elements:

(i) Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred;

(ii) Identification and documentation of the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law;

(A) The source individual's blood shall be tested as soon as feasible and after consent is obtained in order to determine HBV and HIV infectivity. If consent is not obtained, the employer shall establish that legally required consent cannot be obtained. When the source individual's consent is not required by law, the source individual's blood, if available, shall be tested and the results documented.

(B) When the source individual is already known to be infected with HBV or HIV, testing for the source individual's known HBV or HIV status need not be repeated.

(C) Results of the source individual's testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual.

(iii) Collection and testing of blood for HBV and HIV serological status;

(A) The exposed employee's blood shall be collected as soon as feasible and tested after consent is obtained.

(B) If the employee consents to baseline blood collection, but does not give consent at that time for HIV serologic testing, the sample shall be preserved for at least 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing shall be done as soon as feasible.

(iv) Post-exposure prophylaxis, when medically indicated, as recommended by the U.S. Public Health Service;

(v) Counseling; and

(vi) Evaluation of reported illnesses.

(4) "Information provided to the healthcare professional." (i) The employer shall ensure that the healthcare professional responsible for the employee's Hepatitis B vaccination is provided a copy of this regulation.

(ii) The employer shall ensure that the healthcare professional evaluating an employee after an exposure incident is provided the following information:

(A) A copy of this regulation;

(B) A description of the exposed employee's duties as they relate to the exposure incident;

(D) Results of the source individual's blood testing, if available; and

(E) All medical records relevant to the appropriate treatment of the employee including vaccination status which are the employer's responsibility to maintain.

(5) "Healthcare professional's written opinion." The employer shall obtain and provide the employee with a copy of the evaluating healthcare professional's written opinion within 15 days of the completion of the evaluation.

(i) The healthcare professional's written opinion for Hepatitis B vaccination shall be limited to whether Hepatitis B vaccination is indicated for an employee, and if the employee has received such vaccination.

(ii) The healthcare professional's written opinion for post-exposure evaluation and follow-up shall be limited to the following information:

(A) That the employee has been informed of the results of the evaluation; and

(B) That the employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment.

(iii) All other findings or diagnoses shall remain confidential and shall not be included in the written report.

(6) "Medical recordkeeping." Medical records required by this standard shall be maintained in accordance with paragraph (h)(1) of this section.

(g) "Communication of hazards to employees." - (1) "Labels and signs." -

(i) "Labels." (A) Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials, except as provided in paragraph (g)(1)(i)(E), (F) and (G).

(B) Labels required by this section shall include the following legend:

BIOHAZARD (For Illustration, of Biohazard symbol, see printed copy)

(C) These labels shall be fluorescent orange or orange-red or predominantly so, with lettering and symbols in a contrasting color.

(D) Labels shall be affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal.

(E) Red bags or red containers may be substituted for labels.

(F) Containers of blood, blood components, or blood products that are labeled as to their contents and have been released for transfusion or other clinical use are exempted from the labeling requirements of paragraph (g).

(G) Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment or disposal are exempted from the labeling requirement.

(H) Labels required for contaminated equipment shall be in accordance with this paragraph and shall also state which portions of the equipment remain contaminated.

(I) Regulated waste that has been decontaminated need not be labeled or color-coded.

(ii) "Signs." (A) The employer shall post signs at the entrance to work areas specified in paragraph (e), HIV and HBV Research Laboratory and Production Facilities, which shall bear the following legend:

BIOHAZARD
(For Illustration, of Biohazard symbol, see printed copy)

(Name of the Infectious Agent) (Special requirements for entering the area) (Name, telephone number of the laboratory director or other responsible person.)

(B) These signs shall be fluorescent orange-red or predominantly so, with lettering and symbols in a contrasting color.

(2) "Information and training." (i) Employers shall ensure that all employees with occupational exposure participate in a training program which must be provided at no cost to the employee and during working hours.

(ii) Training shall be provided as follows:

(A) At the time of initial assignment to tasks where occupational exposure may take place;

(B) Within 90 days after the effective date of the standard; and

(C) At least annually thereafter. (iii) For employees who have received training on bloodborne pathogens in the year preceding the effective date of the standard, only training with respect to the provisions of the standard which were not included need be provided.

(iv) Annual training for all employees shall be provided within one year of their previous training.

(v) Employers shall provide additional training when changes such as modification of tasks or procedures or institution of new tasks or procedures affect the employee's occupational exposure. The additional training may be limited to addressing the new exposures created.

(vi) Material appropriate in content and vocabulary to educational level, literacy, and language of employees shall be used.

(vii) The training program shall contain at a minimum the following elements:

(A) An accessible copy of the regulatory text of this standard and an explanation of its contents;

(B) A general explanation of the epidemiology and symptoms of bloodborne diseases;

(D) An explanation of the employer's exposure control plan and the means by which the employee can obtain a copy of the written plan;

(E) An explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials;

(F) An explanation of the use and limitations of methods that will prevent or reduce exposure including appropriate engineering controls, work practices, and personal protective equipment;

(G) Information on the types, proper use, location, removal, handling, decontamination and disposal of personal protective equipment;

(H) An explanation of the basis for selection of personal protective equipment;

(I) Information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine and vaccination will be offered free of charge;

(J) Information on the appropriate actions to take and persons to contact in an emergency involving blood or other potentially infectious materials;

(K) An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available;

(L) Information on the post-exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident;

(M) An explanation of the signs and labels and/or color coding required by paragraph (g)(1); and

(N) An opportunity for interactive questions and answers with the person conducting the training session.

(viii) The person conducting the training shall be knowledgeable in the subject matter covered by the elements contained in the training program as it relates to the workplace that the training will address.

(ix) Additional Initial Training for Employees in HIV and HBV Laboratories and Production Facilities. Employees in HIV or HBV research laboratories and HIV or HBV production facilities shall receive the following initial training in addition to the above training requirements.

(A) The employer shall assure that employees demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV or HBV.

(B) The employer shall assure that employees have prior experience in the handling of human pathogens or tissue cultures before working with HIV or HBV.

(C) The employer shall provide a training program to employees who have no prior experience in handling human pathogens. Initial work activities shall not include the handling of infectious agents. A progression of work activities shall be assigned as techniques are learned and proficiency is developed. The employer shall assure that employees participate in work activities involving infectious agents only after proficiency has been demonstrated.

(h) "Recordkeeping." - (1) "Medical records." (i) The employer shall establish and maintain an accurate record for each employee with occupational exposure, in accordance with 29 CFR 1915.1120.

(ii) This record shall include:

(A) The name and social security number of the employee;

(B) A copy of the employee's hepatitis B vaccination status including the dates of all the hepatitis B vaccinations and any medical records relative to the employee's ability to receive vaccination as required by paragraph (f)(2);

(D) The employer's copy of the healthcare professional's written opinion as required by paragraph (f)(5); and

(E) A copy of the information provided to the healthcare professional as required by paragraphs (f)(4)(ii)(B)(C) and (D).

(iii) Confidentiality. The employer shall ensure that employee medical records required by paragraph (h)(1) are:

(A) Kept confidential; and

(B) Not disclosed or reported without the employee's express written consent to any person within or outside the workplace except as required by this section or as may be required by law.

(iv) The employer shall maintain the records required by paragraph (h) for at least the duration of employment plus 30 years in accordance with 29 CFR 1915.1120.

(2) "Training records." (i) Training records shall include the following information:

(A) The dates of the training sessions;

(B) The contents or a summary of the training sessions;

and (D) The names and job titles of all persons attending the training sessions.

(ii) Training records shall be maintained for 3 years from the date on which the training occurred.

(3) "Availability." (i) The employer shall ensure that all records required to be maintained by this section shall be made available upon request to the Assistant Secretary and the Director for examination and copying.

(ii) Employee training records required by this paragraph shall be provided upon request for examination and copying to employees, to employee representatives, to the Director, and to the Assistant Secretary.

(iii) Employee medical records required by this paragraph shall be provided upon request for examination and copying to the subject employee, to anyone having written consent of the subject employee, to the Director, and to the Assistant Secretary in accordance with 29 CFR 1915.1120.

(4) "Transfer of records." (i) The employer shall comply with the requirements involving transfer of records set forth in 29 CFR 1915.1120(h).

(ii) If the employer ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, the employer shall notify the Director, at least three months prior to their disposal and transmit them to the Director, if required by the Director to do so, within that three month period.

(i) "Dates." - (1) "Effective date." The standard shall become effective on March 6, 1992.

(2) The Exposure Control Plan required by paragraph (c) of this section shall be completed on or before May 5, 1992.

(3) Paragraph (g)(2) Information and Training and (h) Recordkeeping shall take effect on or before June 4, 1992.

(4) Paragraphs (d)(2) Engineering and Work Practice Controls, (d)(3) Personal Protective Equipment, (d)(4) Housekeeping, (e) HIV and HBV Research Laboratories and Production Facilities, (f) Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up, and (g)(1) Labels and Signs, shall take effect July 6, 1992.

[58 FR 35634, July 1, 1993]

1915.1030 Appendix A

Appendix A - Hepatitis B Vaccine Declination (Mandatory).

I understand that due to my occupational exposure to blood or other potentially infectious materials I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no charge to me.

(Approved by the Office of Management and Budget under control number 1218-0180)

[58 FR 35641, July 1, 1993]

1915.1044 1,2-dibromo-3-chloropropane.

(a) "Scope and application." (1) This section applies to occupational exposure to 1,2-dibromo-3-chloropropane (DBCP).

(2) This section does not apply to:

(i) Exposure to DBCP which results solely from the application and use of DBCP as a pesticide; or (ii) The storage, transportation, distribution or sale of DBCP in intact containers sealed in such a manner as to prevent exposure to DBCP vapors or liquid, except for the requirements of paragraphs (i), (n) and (o) of this section.

(b) "Definitions." "Authorized person" means any person required by his duties to be present in regulated areas and authorized to do so by his employer, by this section, or by the Act. "Authorized person" also includes any person entering such areas as a designated representative of employees exercising an opportunity to observe employee exposure monitoring.

"DBCP" means 1,2-dibromo-3-chloropropane, Chemical Abstracts Service Registry Number 96-12-8, and includes all forms of DBCP.

"Director" means the Director, National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee.

"Emergency" means any occurrence such as, but not limited to equipment failure, rupture of containers, or failure of control equipment which may, or does, result in an unexpected release of DBCP.

"OSHA Area Office" means the Area Office of the Occupational Safety and Health Administration having jurisdiction over the geographic area where the affected workplace is located.

"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.

(c) "Permissible exposure limit" - (1) "Inhalation." The employer shall assure that no employee is exposed to an airborne concentration of DBCP in excess of 1 part DBCP per billion parts of air (ppb) as an 8-hour time-weighted average.

(2) "Dermal and eye exposure." The employer shall assure that no employee is exposed to eye or skin contact with DBCP.

(d) "Notification of use." Within ten (10) days following the introduction of DBCP into the workplace, every employer who has a workplace where DBCP is present, shall report the following information to the nearest OSHA Area Office for each such workplace;

(1) The address and location of the workplace:

(2) A brief description of each process or operation which may result in employee exposure to DBCP;

(3) The number of employees engaged in each process or operation who may be exposed to DBCP and an estimate of the frequency and degree of exposure that occurs; and

(4) A brief description of the employer's safety and health program as it relates to limitation of employee exposure to DBCP.

(e) "Regulated areas." (1) The employer shall establish, within each place of employment, regulated areas wherever DBCP concentrations are in excess of the permissible exposure limit.

(2) The employer shall limit access to regulated areas to authorized persons.

(f) "Exposure monitoring" - (1) "General." (i) Determinations of airborne exposure levels shall be made from air samples that are representative of each employee's exposure to DBCP over an 8-hour period.

(ii) For the purposes of this paragraph, employee exposure is that exposure which would occur if the employee were not using a respirator.

(2) "Initial." Each employer who has a place of employment in which DBCP is present, shall monitor each workplace and work operation to accurately determine the airborne concentrations of DBCP to which employees may be exposed.

(3) "Frequency." (i) If the monitoring required by this section reveals employee exposures to be below the permissible exposure limit, the employer shall repeat these measurements at least quarterly.

(ii) If the monitoring required by this section reveals employee exposures to be in excess of the permissible exposure limit, the employer shall repeat these measurements for each such employee at least monthly. The employer shall continue monthly monitoring until at least two consecutive measurements, taken at least seven (7) days apart, are below the permissible exposure limit. Thereafter the employer shall monitor at least quarterly.

(4) "Additional." Whenever there has been a production, process, control, or personnel change which may result in any new or additional exposure to DBCP, or whenever the employer has any reason to suspect new or additional exposures to DBCP, the employer shall monitor the employees potentially affected by such change for the purpose of redetermining their exposure.

(5) "Employee notification." (i) Within five (5) working days after the receipt of monitoring results, the employer shall notify each employee in writing of the measurements which represent the employee's exposure.

(ii) Whenever the results indicate that employee exposure exceeds the permissible exposure limit, the employer shall include in the written notice a statement that the permissible exposure limit was exceeded and a description of the corrective action being taken to reduce exposure to or below the permissible exposure limit.

(6) "Accuracy of measurement." The employer shall use a method of measurement which has an accuracy, to a confidence level of 95 percent, of not less than plus or minus 25 percent for concentrations of DBCP at or above the permissible exposure limit.

(g) "Methods of compliance" - (1) "Priority of compliance methods." The employer shall institute engineering and work practice controls to reduce and maintain employee exposures to DBCP at or below the permissible exposure limit, except to the extent that the employer establishes that such controls are not feasible. Where feasible engineering and work practice controls are not sufficient to reduce employee exposures to within the permissible exposure limit, the employer shall nonetheless use them to reduce exposures to the lowest level achievable by these controls, and shall supplement them by use of respiratory protection.

(2) "Compliance program." (i) The employer shall establish and implement a written program to reduce employee exposures to DBCP to or below the permissible exposure limit solely by means of engineering and work practice controls as required by paragraph (g)(1) of this section.

(ii) The written program shall include a detailed schedule for development and implementation of the engineering and work practice controls. These plans shall be revised at least every six months to reflect the current status of the program.

(iii) Written plans for these compliance programs shall be submitted upon request to the Assistant Secretary and the Director, and shall be available at the worksite for examination and copying by the Assistant Secretary, the Director, and any affected employee or designated representative of employees.

(iv) The employer shall institute and maintain at least the controls described in his most recent written compliance program.

(h) "Respirators" - (1) "General." Where respiratory protection is required under this section, the employer shall select, provide and assure the proper use of respirators. Respirators shall be used in the following circumstances:

(i) During the period necessary to install or implement feasible engineering and work practice controls; or (ii) During maintenance and repair activities in which engineering and work practice controls are not feasible; or (iii) In work situations where feasible engineering and work practice controls are not yet sufficient to reduce exposure to or below the permissible exposure limit; or (iv) In emergencies. (2) "Respirator selection." (i) Where respirators are required under this section, the employer shall select and provide, at no cost to the employee,the appropriate respirator from Table 1 below and shall assure that the employee uses the respirator provided.

(ii) The employer shall select respirators from among those approved by the National Institute for Occupational Safety and Health (NIOSH) under the provisions of 30 CFR Part 11.

TABLE 1 - RESPIRATORY PROTECTION FOR DBCP
Airborne concentration of DBCP or condition of use	Respirator type
(a) Less than or equal to 10 ppb..	(1) Any supplied-air respirator; or (2) any self-contained breathing apparatus.
(b) Less than or equal to 50 ppb..	(1) Any supplied-air respirator with full facepiece, helmet, or hood; or (2) any self-contained breathing apparatus with full facepiece.
(c) Less than or equal to 1,000 ppb	(1) A Type C supplied-air respirator operated in pressure-demand or other positive pressure or continuous flow mode.
(d) Less than or equal to	(1) A Type C supplied-air respirator
2,000 ppb	with full facepiece operated in pressure-demand or other positive pressure mode, or with full facepiece, helmet, or hood operated in continuous flow mode.
(e) Greater than 2,000 ppb or entry and escape from unknown concentrations.	(1) A combination respirator which includes a Type C supplied-air respirator with full facepiece operated in pressure-demand or other positive pressure or continuous flow mode and an auxiliary self-contained breathing apparatus operated in pressure-demand or positive pressure mode; or (2) a self-contained breathing apparatus with full facepiece operated in pressure-demand or other positive pressure mode.
(f) Firefighting	(1) A self-contained breathing apparatus with full facepiece operated in pressure-demand or other positive pressure mode.

(3) "Respirator program." (i) The employer shall institute a respiratory protection program in accordance with 29 CFR 1910.134(b), (d), (e), and (f).

(ii) Employees who wear respirators shall be allowed to wash their faces and respirator facepieces as needed to prevent potential skin irritation associated with respirator use.

(i) "Emergency situations" - (1) "Written plans." (i) A written plan for emergency situations shall be developed for each workplace in which DBCP is present.

(ii) Appropriate portions of the plan shall be implemented in the event of an emergency.

(2) Employees engaged in correcting emergency conditions shall be equipped as required in paragraphs (h) and (j) of this section until the emergency is abated.

(3) "Evacuation." Employees not engaged in correcting the emergency shall be removed and restricted from the area and normal operations in the affected area shall not be resumed until the emergency is abated.

(4) "Alerting employees." Where there is a possibility of employee exposure to DBCP due to the occurrence of an emergency, a general alarm shall be installed and maintained to promptly alert employees of such occurrences.

(5) "Medical surveillance." For any employee exposed to DBCP in an emergency situation, the employer shall provide medical surveillance in accordance with paragraph (m)(6) of this section.

(6) "Exposure monitoring." (i) Following an emergency, the employer shall conduct monitoring which complies with paragraph (f) of this section.

(ii) In workplaces not normally subject to periodic monitoring, the employer may terminate monitoring when two consecutive measurements indicate exposures below the permissible exposure limit.

(j) "Protective clothing and equipments" - (1) "Provision and use."

Where there is any possibility of eye or dermal contact with liquid or solid DBCP, the employer shall provide, at no cost to the employee, and assure that the employee wears impermeable protective clothing and equipment to protect the area of the body which may come in contact with DBCP. Eye and face protection shall meet the requirements of 1910.133 of this title.

(2) "Removal and storage." (i) The employer shall assure that employees remove DBCP contaminated work clothing only in change rooms provided in accordance with paragraph (l)(1) of this section.

(ii) The employer shall assure that employees promptly remove any protective clothing and equipment which becomes contaminated with DBCP-containing liquids and solids. This clothing shall not be reworn until the DBCP has been removed from the clothing or equipment.

(iii) The employer shall assure that no employee takes DBCP contaminated protective devices and work clothing out of the change room, except those employees authorized to do so for the purpose of laundering, maintenance, of disposal.

(iv) DBCP-contaminated protective devices and work clothing shall be placed and stored in closed containers which prevent dispersion of the DBCP outside the container.

(v) Containers of DBCP contaminated protective devices or work clothing which are to be taken out of change rooms or the workplace for cleaning, maintenance or disposal, shall bear labels in accordance with paragraph (o)(3) of this section.

(ii) The employer shall inform any person who launders or clean DBCP-contaminated protective clothing or equipment of the potentially harmful effects of exposure to DBCP.

(iii) The employer shall prohibit the removal of DBCP from protective clothing and equipment by blowing or shaking.

(k) "Housekeeping" - (1) "Surfaces." (i) All workplace surfaces shall be maintained free of visible accumulations of DBCP.

(ii) Dry sweeping and the use of compressed air for the cleaning of floors and other surfaces is prohibited where DBCP dusts or liquids are present.

(iii) Where vacuuming methods are selected to clean floors and other surfaces, either portable units or a permanent system may be used.

(A) If a portable unit is selected, the exhaust shall be attached to the general workplace exhaust ventilation system or collected within the vacuum unit, equipped with high efficiency filters or other appropriate means of contaminant removal, so that DBCP is not reintroduced into the workplace air; and

(B) Portable vacuum units used to collect DBCP may not be used for other cleaning purposes and shall be labeled as prescribed by paragraph (o)(3) of this section.

(iv) Cleaning of floors and other surfaces contaminated with DBCP-containing dusts shall not be performed by washing down with a hose, unless a fine spray has first been laid down.

(2) "Liquids." Where DBCP is present in a liquid form, or as a resultant vapor, all containers or vessels containing DBCP shall be enclosed to the maximum extent feasible and tightly covered when not in use.

(3) "Waste disposal." DBCP waste scrap, debris, containers or equipment, shall be disposed of in sealed bags or other closed containers which prevent dispersion of DBCP outside the container.

(l) "Hygiene facilities and practices" - (1) "Change rooms." The employer shall provide clean change rooms equipped with storage facilities for street clothes and separate storage facilities for protective clothing and equipment whenever employees are required to wear protective clothing and equipment in accordance with paragraphs (h) and (j) of this section.

(2) "Showers." (i) The employer shall assure that employees working in the regulated area shower at the end of the work shift.

(ii) The employer shall assure that employees whose skin becomes contaminated with DBCP-containing liquids or solids immediately wash or shower to remove any DBCP from the skin.

(iii) The employer shall provide shower facilities in accordance with 29 CFR 1910.141(d)(3).

(3) "Lunchrooms." The employer shall provide lunchroom facilities which have a temperature controlled, positive pressure, filtered air supply, and which are readily accessible to employees working in regulated areas.

(4) "Lavatories." (i) The employer shall assure that employees working in the regulated area remove protective clothing and wash their hands and face prior to eating.

(ii) The employer shall provide a sufficient number of lavatory facilities which comply with 29 CFR 1910.141(d)(1) and (2).

(5) "Prohibition of activities in regulated areas." The employer shall assure that, in regulated areas, food or beverages are not present or consumed, smoking products and implements are not present or used, and cosmetics are not present or applied.

(m) "Medical surveillance" - (1) "General." (i) The employer shall make available a medical surveillance program for employees who work in regulated areas and employees who are subjected to DBCP exposures in an emergency situation.

(ii) All medical examinations and procedures shall be performed by or under the supervision of a licensed physician, and shall be provided without cost to the employee.

(2) "Frequency and content." At the time of initial assignment, and annually thereafter, the employer shall provide a medical examination for employees who work in regulated areas, which includes at least the following:

(i) A medical and occupational history including reproductive history.

(ii) A physical examination, including examination of the genitourinary tract, testicle size and body habitus, including a determination of sperm count.

(iii) A serum specimen shall be obtained and the following determinations made by radioimmunoassay techniques utilizing National Institutes of Health (NIH) specific antigen or one of equivalent sensitivity:

(A) Serum follicle stimulating hormone (FSH);

(B) Serum luteinizing hormone (LH); and

(iv) Any other tests deemed appropriate by the examining physician.

(3) "Additional examinations." If the employee for any reason develops signs or symptoms commonly associated with exposure to DBCP, the employer shall provide the employee with a medical examination which shall include those elements considered appropriate by the examining physician.

(4) "Information provided to the physician." The employer shall provide the following information to the examining physician:

(i) A copy of this regulation and its appendices;

(ii) A description of the affected employee's duties as they relate to the employee's exposure;

(iii) The level of DBCP to which the employee is exposed; and

(iv) A description of any personal protective equipment used or to be used.

(5) "Physician's written opinion." (i) For each examination under this section, the employer shall obtain and provide the employee with a written opinion from the examining physician which shall include:

(A) The results of the medical tests performed;

(B) The physician's opinion as to whether the employee has any detected medical condition which would place the employee at an increased risk of material impairment of health from exposure to DBCP; and

(C) Any recommended limitations upon the employee's exposure to DBCP or upon the use of protective clothing and equipment such as respirators.

(ii) The employer shall instruct the physician not to reveal in the written opinion specific findings or diagnoses unrelated to occupational exposure.

(6) "Emergency situations." If the employee is exposed to DBCP in an emergency situation, the employer shall provide the employee with a sperm count test as soon as practicable, or, if the employee has been vasectionized or is unable to produce a semen specimen, the hormone tests contained in paragraph (m)(2)(iii) of this section. The employer shall provide these same tests three months later.

(n) "Employee information and training" - (1) "Training program." (i) The employer shall institute a training program for all employees who may be exposed to DBCP and shall assure their participation in such training program.

(ii) The employer shall assure that each employee is informed of the following:

(A) The information contained in Appendix A;

(B) The quantity, location, manner of use, release or storage of DBCP and the specific nature of operations which could result in exposure to DBCP as well as any necessary protective steps;

(D) The purpose and description of the medical surveillance program required by paragraph (m) of this section; and

(E) A review of this standard, including appendices.

(2) "Access to training materials." (i) The employer shall make a copy of this standard and its appendices readily available to all affected employees.

(ii) The employer shall provide, upon request, all materials relating to the employee information and training program to the Assistant Secretary and the Director.

(o) "Signs and labels" - (1) "General. "(i) The employer may use labels or signs required by other statutes, regulations, or ordinances in addition to or in combination with, signs and labels required by this paragraph.

(ii) The employer shall assure that no statement appears on or near any sign or label required by this paragraph which contradicts or detracts from the required sign or label.

(2) "Signs." (i) The employer shall post signs to clearly indicate all regulated areas. These signs shall bear the legend:

DANGER
1,2-Dibromo-3-chloropropane

(Insert appropriate trade or common names)
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATOR REQUIRED

(3) "Labels." (i) The employer shall assure that precautionary labels are affixed to all containers of DBCP and of products containing DBCP in the workplace, and that the labels remain affixed when the DBCP or products containing DBCP are sold, distributed, or otherwise leave the employer's workplace. Where DBCP or products containing DBCP are sold, distributed or otherwise leave the employer's workplace bearing appropriate labels required by EPA under the regulations in 40 CFR Part 162, the labels required by this paragraph need not be affixed.

(ii) The employer shall assure that the precautionary labels required by this paragraph are readily visible and legible. The labels shall bear the following legend:

DANGER
1,2-Dibromo-3-chloropropane
CANCER HAZARD

(p) "Recordkeeping" - (1) "Exposure monitoring." (i) The employer shall establish and maintain an accurate record of all monitoring required by paragraph (f) of this section.

(ii) This record shall include:

(A) The dates, number, duration and results of each of the samples taken,including a description of the sampling procedure used to determine representative employee exposure;

(B) A description of the sampling and analytical methods used;

(D) Name, social security number, and job classification of the employee monitored and of all other employees whose exposure the measurement is intended to represent.

(iii) The employer shall maintain this record for at least 40 years or the duration of employment plus 20 years, whichever is longer.

(2) "Medical surveillance." (i) The employer shall establish and maintain an accurate record for each employee subject to medical surveillance required by paragraph (m) of this section.

(ii) This record shall include:

(A) The name and social security number of the employee;

(B) A copy of the physician's written opinion;

(D) A copy of the information provided the physician as required by paragraphs (m)(4)(ii) through (m)(4)(iv) of this section; and

(E) A copy of the employee's medical and work history.

(iii) The employer shall maintain this record for at least 40 years or the duration of employment plus 20 years, whichever is longer.

(3) "Availability." (i) The employer shall assure that all records required to be maintained by this section be made available upon request to the Assistant Secretary and the Director for examination and copying.

(ii) Employee exposure monitoring records and employee medical records required by this paragraph shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a) through (e) and (g) through (i).

(4) "Transfer of records." (i) If the employer ceases to do business, the successor employer shall receive and retain all records required to be maintained by paragraph (p) of this section for the prescribed period.

(ii) If the employer ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, the employer shall transmit these records by mail to the Director.

(iii) At the expiration of the retention period for the records required to be maintained under paragraph (p) of this section, the employer shall transmit these records by mail to the Director.

(iv) The employer shall also comply with any additional requirements involving transfer of records set forth in 29 CFR 1915.1120(h).

(q) "Observation of monitoring" - (1) "Employee observation." The employer shall provide affected employees, or their designated representatives, with an opportunity to observe any monitoring of employee exposure to DBCP required by this section.

(2) "Observation procedures." (i) Whenever observation of the measuring or monitoring of employee exposure to DBCP requires entry into an area where the use of protective clothing or equipment is required, the employer shall provide the observer with personal protective clothing or equipment required to be worn by employees working in the area, assure the use of such clothing and equipment, and require the observer to comply with all other applicable safety and health procedures.

(ii) Without interfering with the monitoring or measurement, observers shall be entitled to:

(A) Receive an explanation of the measurement procedures;

(B) Observe all steps related to the measurement of airborne concentrations of DBCP performed at the place of exposure; and

(C) Record the results obtained. (r) "Appendices." The information contained in the appendices is not intended, by itself, to create any additional obligations not otherwise imposed or to detract from any existing obligation.

(Approved by the Office of Management and Budget under control number 1218-0101)

[58 FR 35641, July 1, 1993]

1915.1044 Appendix A Substance safety data sheet for DBCP

I. "Substance Identification"

A. Synonyms and trades names: DBCP; Dibromochloropropane; Fumazone (Dow Chemical Company TM); Nemafume; Nemagon (Shell Chemical Co. TM); Nemaset; BBC 12; and OS 1879.

B. Permissible exposure:

1. "Airborne." 1 part DBCP vapor per billion parts of air (1 ppb); time-weighted average (TWA) for an 8-hour workday.

2. "Dermal." Eye contact and skin contact with DBCP are prohibited.

C. Appearance and odor: Technical grade DBCP is a dense yellow or amber liquid with a pungent odor. It may also appear in granular form, or blended in varying concentrations with other liquids.

D. Uses: DBCP is used to control nematodes, very small worm-like plant parasites, on crops including cotton, soybeans, fruits, nuts, vegetables and ornamentals.

II. "Health Hazard Data"

A. Routes of entry: Employees may be exposed:

1. Through inhalation (breathing);

2. Through ingestion (swallowing);

3. Skin contact; and

4. Eye contact.

B. Effects of exposure: 1. "Acute exposure." DBCP may cause drowsiness, irritation of the eyes, nose, throat and skin, nausea and vomiting. In addition, overexposure may cause damage to the lungs, liver or kidneys.

2. "Chronic exposure." Prolonged or repeated exposure to DBCP has been shown to cause sterility in humans. It also has been shown to produce cancer and sterility in laboratory animals and has been determined to constitute an increased risk of cancer in man.

3. "Reporting Signs and Symptoms." If you develop any of the above signs or symptoms that you think are caused by exposure to DBCP, you should inform your employer.

III. "Emergency First Aid Procedures"

A. "Eye exposure." If DBCP liquid or dust containing DBCP gets into your eyes, wash your eyes immediately with large amounts of water, lifting the lower and upper lids occasionally. Get medical attention immediately. Contact lenses should not be worn when working with DBCP.

B. "Skin exposure." If DBCP liquids or dusts containing DBCP get on your skin, immediately wash using soap or mild detergent and water. If DBCP liquids or dusts containing DBCP penetrate through your clothing, remove the clothing immediately and wash. If irritation is present after washing get medical attention.

C. "Breathing." If you or any person breathe in large amounts of DBCP, move the exposed person to fresh air at once. If breathing has stopped, perform artificial respiration. Do not use mouth-to-mouth. Keep the affected person warm and at rest. Get medical attention as soon as possible.

D. "Swallowing." When DBCP has been swallowed and the person is conscious, give the person large amounts of water immediately. After the water has been swallowed, try to get the person to vomit by having him touch the back of his throat with his finger. Do not make an unconscious person vomit. Get medical attention immediately.

E. "Rescue." Notify someone. Put into effect the established emergency rescue procedures. Know the locations of the emergency rescue equipment before the need arises.

IV. "Respirators and Protective Clothing"

A. "Respirators." You may be required to wear a respirator in emergencies and while your employer is in the process of reducing DBCP exposures through engineering controls. If respirators are worn, they must have a National Institute for Occupational Safety and Health (NIOSH) approval label (Older respirators may have a Bureau of Mines Approval label). For effective protection, a respirator must fit your face and head snugly. The respirator should not be loosened or removed in work situations where its use is required. DBCP does not have a detectable odor except at 1,000 times or more above the permissible exposure limit. If you can smell DBCP while wearing a respirator, the respirator is not working correctly; go immediately to fresh air. If you experience difficulty breathing while wearing a respirator, tell your employer.

B. "Protective clothing." When working with DBCP you must wear for your protection impermeable work clothing provided by your employer. (Standard rubber and neoprene protective clothing do not offer adequate protection).

DBCP must never be allowed to remain on the skin. Clothing and shoes must not be allowed to become contaminated with DBCP, and if they do, they must be promptly removed and not worn again until completely free of DBCP. Turn in impermeable clothing that has developed leaks for repair or replacement.

C. "Eye protection." You must wear splash-proof safety goggles where there is any possibility of DBCP liquid or dust contacting your eyes.

V. "Precautions for Safe Use, Handling, and Storage"

A. DBCP must be stored in tightly closed containers in a cool, well-ventilated area.

B. If your work clothing may have become contaminated with DBCP, or liquids or dusts containing DBCP, you must change into uncontaminated clothing before leaving the work premises.

C. You must promptly remove any protective clothing that becomes contaminated with DBCP. This clothing must not be reworn until the DBCP is removed from the clothing.

D. If your skin becomes contaminated with DBCP, you must immediately and thoroughly wash or shower with soap or mild detergent and water to remove any DBCP from your skin.

E. You must not keep food, beverages, cosmetics, or smoking materials, nor eat or smoke, in regulated areas.

F. If you work in a regulated area, you must wash your hands thoroughly with soap or mild detergent and water, before eating, smoking or using toilet facilities.

G. If you work in a regulated area, you must remove any protective equipment or clothing before leaving the regulated area.

H. Ask your supervisor where DBCP is used in your work area and for any additional safety and health rules.

VI. "Access to Information"

A. Each year, your employer is required to inform you of the information contained in this Substance Safety Data Sheet for DBCP. In addition, your employer must instruct you in the safe use of DBCP, emergency procedures, and the correct use of protective equipment.

B. Your employer is required to determine whether you are being exposed to DBCP. You or your representative have the right to observe employee exposure measurements and to record the result obtained. Your employer is required to inform you of your exposure. If your employer determines that you are being overexposed, he is required to inform you of the actions which are being taken to reduce your exposure.

C. Your employer is required to keep records of your exposure and medical examinations. Your employer is required to keep exposure and medical data for at least 40 years or the duration of your employment plus 20 years, whichever is longer.

D. Your employer is required to release exposure and medical records to you, your physician, or other individual designated by you upon your written request.

[58 FR 35645, July 1, 1993]

1915.1044 Appendix B Substance technical guidelines for DBCP.

I. "Physical and Chemical Data"

A. Substance Identification 1. Synonyms: 1,2-dibromo-3-chloropropane; DBCP, Fumazone; Nemafume; Nemagon; Nemaset; BBC 12; OS 1879. DBCP is also included in agricultural pesticides and fumigants which include the phrase "Nema---" in their name.

2. Formula: C(3)H(5)Br(2)C1.

3. Molecular Weight: 236.

B. Physical Data: 1. Boiling point (760 mm HG): 195 C (383 F)

2. Specific gravity (water=1): 2.093.

3. Vapor density (air=1 at boiling point of DBCP): Data not available.

4. Melting point: 6 C (43 F).

5. Vapor pressure at 20 C (68 F): 0.8 mm Hg

6. Solubility in water: 1000 ppm.

7. Evaporation rate (Butyl Acetate=1): very much less than 1.

8. Appearance and odor: Dense yellow or amber liquid with a pungent odor at high concentrations. Any detectable odor of DBCP indicates overexposure.

II. "Fire Explosion and Reactivity Hazard Data"

A. Fire 1. Flash point: 170 F (77 C) 2. Autoignition temperature: Data not available. 3. Flammable limits in air, percent by volume: Data not available. 4. Extinguishing media: Carbon dioxide, dry chemical. 5. Special fire-fighting procedures: Do not use a solid stream of water since a stream will scatter and spread the fire. Use water spray to cool containers exposed to a fire. 6. Unusual fire and explosion hazards: None known. 7. For purposes of complying with the requirements of 1910.106, liquid DBCP is classified as a Class III A combustible liquid. 8. For the purpose of complying with 1910.309, the classification of hazardous locations as described in article 500 of the National Electrical Code for DBCP shall be Class I, Group D. 9. For the purpose of compliance with 1910.157, DBCP is classified as a Class B fire hazard. 10. For the purpose of compliance with 1910.178, locations classified as hazardous locations due to the presence of DBCP shall be Class I, Group D. 11. Sources of ignition are prohibited where DBCP presents a fire or explosion hazard.

B. Reactivity 1. Conditions contributing to instability: None known. 2. Incompatibilities: Reacts with chemically active metals, such as aluminum, magnesium and tin alloys. 3. Hazardous decomposition products: Toxic gases and vapors (such as HBr, HCl and carbon monoxide) may be released in a fire involving DBCP. 4. Special precautions: DBCP will attack some rubber materials and coatings.

III. "Spill, Leak and Disposal Procedures"

A. If DBCP is spilled or leaked, the following steps should be taken: 1. The area should be evacuated at once and re-entered only after thorough ventilation. 2. Ventilate area of spill or leak. 3. If in liquid form, collect for reclamation or absorb in paper, vermiculite, dry sand, earth or similar material. 4. If in solid form, collect spilled material in the most convenient and safe manner for reclamation or for disposal.

B. Persons not wearing protective equipment must be restricted from areas of spills or leaks until cleanup has been completed.

C. Waste Disposal Methods:

1. For small quantities of liquid DBCP, absorb on paper towels, remove to a safe place (such as a fume hood) and burn the paper. Large quantities can be reclaimed or collected and atomized in a suitable combustion chamber equipped with an appropriate effluent gas cleaning device. If liquid DBCP is absorbed in vermiculite, dry sand, earth or similar material and placed in sealed containers it may be disposed of in a State-approved sanitary landfill. 2. If in solid form, for small quantities, place on paper towels, remove to a safe place (such as a fume hood) and burn. Large quantities may be reclaimed. However, if this is not practical, dissolve in a flammable solvent (such as alcohol) and atomize in a suitable combustion chamber equipped with an appropriate effluent gas cleaning device. DBCP in solid form may also be disposed in a state-approved sanitary landfill.

IV. "Monitoring and Measurement Procedures"

A. Exposure above the permissible exposure limit. 1. "Eight Hour Exposure Evaluation:" Measurements taken for the purpose of determining employee exposure under this section are best taken so that the average 8-hour exposure may be determined from a single 8-hour sample or two (2) 4-hour samples. Air samples should be taken in the employee's breathing zone (air that would most nearly represent that inhaled by the employee).

2. "Monitoring Techniques:" The sampling and analysis under this section may be performed by collecting the DBCP vapor on petroleum based charcoal absorption tubes with subsequent chemical analyses. The method of measurement chosen should determine the concentration of airborne DBCP at the permissible exposure limit to an accuracy of plus or minus 25 percent. If charcoal tubes are used, a total volume of 10 liters should be collected at a flow rate of 50 cc. per minute for each tube. Analyze the resultant samples as you would samples of halogenated solvent.

B. Since many of the duties relating to employee protection are dependent on the results of monitoring and measuring procedures, employers should assure that the evaluation of employee exposures is performed by a competent industrial hygienist or other technically qualified person.

V. "Protective Clothing"

Employees should be required to wear appropriate protective clothing to prevent any possibility of skin contact with DBCP. Because DBCP is absorbed through the skin, it is important to prevent skin contact with both liquid and solid forms of DBCP. Protective clothing should include impermeable coveralls or similar fullbody work clothing, gloves, headcoverings, and workshoes or shoe coverings. Standard rubber and neoprene gloves do not offer adequate protection and should not be relied upon to keep DBCP off the skin. DBCP should never be allowed to remain on the skin. Clothing and shoes should not be allowed to become contaminated with the material, and if they do, they should be promptly removed and not worn again until completely free of the material. Any protective clothing which has developed leaks or is otherwise found to be defective should be repaired or replaced. Employees should also be required to wear splash-proof safety goggles where there is any possibility of DBCP contacting the eyes.

VI. "Housekeeping and Hygiene Facilities"

1. The workplace must be kept clean, orderly and in a sanitary condition;

2. Dry sweeping and the use of compressed air is unsafe for the cleaning of floors and other surfaces where DBCP dust or liquids are found. To minimize the contamination of air with dust, vacuuming with either portable or permanent systems must be used. If a portable unit is selected,the exhaust must be attached to the general workplace exhaust ventilation system, or collected within the vacuum unit equipped with high efficiency filters or other appropriate means of contamination removal and not used for other purposes. Units used to collect DBCP must be labeled.

3. Adequate washing facilities with hot and cold water must be provided, and maintained in a sanitary condition. Suitable cleansing agents should also be provided to assure the effective removal of DBCP from the skin.

4. Change or dressing rooms with individual clothes storage facilities must be provided to prevent the contamination of street clothes with DBCP. Because of the hazardous nature of DBCP, contaminated protective clothing must be stored in closed containers for cleaning or disposal.

VII. "Miscellaneous Precautions"

A. Store DBCP in tightly closed containers in a cool, well ventilated area.

B. Use of supplied-air suits or other impervious clothing (such as acid suits) may be necessary to prevent skin contact with DBCP. Supplied-air suits should be selected, used, and maintained under the supervision of persons knowledgeable in the limitations and potential life-endangering characteristics of supplied-air suits.

C. The use of air-conditioned suits may be necessary in warmer climates.

D. Advise employees of all areas and operations where exposure to DBCP could occur.

VIII. "Common Operations"

Common operations in which exposure to DBCP is likely to occur are:

during its production; and during its formulation into pesticides and fumigants.

[58 FR 35646, July 1, 1993]

1915.1044 Appendix C Medical surveillance guidelines for DBCP.

I. "Route of Entry"

Inhalation; skin absorption

II. "Toxicology"

Recent data collected on workers involved in the manufacture and formulation of DBCP has shown that DBCP can cause sterility at very low levels of exposure. This finding is supported by studies showing that DBCP causes sterility in animals. Chronic exposure to DBCP resulted in pronounced necrotic action on the parenchymatous organs (i.e., liver, kidney, spleen) and on the testicles of rats at concentrations as low as 5 ppm. Rats that were chronically exposed to DBCP also showed changes in the composition of the blood, showing low ABC, hemoglobin, and WBC, and high reticulocyte levels as well as functional hepatic disturbance, manifesting itself in a long prothrombin time. Reznik et al. noted a single dose of 100 mg produced profound depression of the nervous system of rats. Their condition gradually improved. Acute exposure also resulted in the destruction of the sex gland activity of male rats as well as causing changes in the estrous cycle in female rats. Animal studies have also associated DBCP with an increased incidence of carcinoma. Olson, et al. orally administered DBCP to rats and mice 5 times per week at experimentally predetermined maximally tolerated doses and at half those doses. As early as ten weeks after initiation of treatment, DBCP induce a high incidence of squamous cell carcinomas of the stomach with metastases in both species. DBCP also induced mammary adenocarcinomas in the female rats at both dose levels.

III. "Signs and Symptoms"

A. Inhalation: Nausea, eye irritation, conjunctivitis, respiratory irritation, pulmonary congestion or edema, CNS depression with apathy, sluggishness, and ataxia.

B. Dermal: Erythema or inflammation and dermatitis on repeated exposure.

IV. "Special Tests"

A. "Semen analysis:" The following information excerpted from the document "Evaluation of Testicular Function", submitted by the Corporate Medical Department of the Shell Oil Company (exhibit 39-3), may be useful to physicians conducting the medical surveillance program;

In performing semen analyses certain minimal but specific criteria should be met:

1. It is recommended that a minimum of three valid semen analyses be obtained in order to make a determination of an individual's average sperm count.

2. A period of sexual abstinence is necessary prior to the collection of each masturbatory sample. It is recommended that intercourse or masturbation be performed 48 hours before the actual specimen collection. A period of 48 hours of abstinence would follow; then the masturbatory sample would be collected.

3. Each semen specimen should be collected in a clean, widemouthed, glass jar (not necessarily pre-sterilized) in a manner designated by the examining physician. Any part of the seminal fluid exam should be initialed "only after liquefaction" is complete, i.e., 30 to 45 minutes after collection.

4. Semen volume should be measured to the nearest 1/10 of a cubic centimeter.

5. Sperm density should be determined using routine techniques involving the use of a white cell pipette and a hemocytometer chamber. The immobilizing fluid most effective and most easily obtained for this process is distilled water.

6. Thin, dry smears of the semen should be made for a morphologic classification of the sperm forms and should be stained with either hematoxalin or the more difficult, yet more precise, Papanicolaou technique. Also of importance to record is obvious sperm agglutination, pyospermia, delayed liquefaction (greater than 30 minutes), and hyperviscosity. In addition, pH, using nitrazine paper, should be determined.

7. A total morphology evaluation should include percentages of the following:

a. Normal (oval) forms, b. Tapered forms, c. Amorphous forms (include large and small sperm shapes), d. Duplicated (either heads or tails) forms, and e. Immature forms.

8. Each sample should be evaluated for sperm "viability" (percent viable sperm moving at the time of examination) as well as sperm "motility" (subjective characterization of "purposeful forward sperm progression" of the majority of those viable sperm analyzed) within two hours after collection, ideally by the same or equally qualified examiner.

B. "Serum determinations:" The following serum determinations should be performed by radioimmuno-assay techniques using National Institutes of Health (NIH) specific antigen or antigen preparations of equivalent sensitivity:

1. Serum follicle stimulating hormone (FSH);

2. Serum luteinizing hormone (LH); and

3. Serum total estrogen (females only).

V. "Treatment"

Remove from exposure immediately, give oxygen or artificial resuscitation if indicated. Contaminated clothing and shoes should be removed immediately. Flush eyes and wash contaminated skin. If swallowed and the person is conscious, induce vomiting. Recovery from mild exposures is usually rapid and complete.

VI. "Surveillance and Preventive Considerations"

A. "Other considerations." DBCP can cause both acute and chronic effects. It is important that the physician become familiar with the operating conditions in which exposure to DBCP occurs. Those with respiratory disorders may not tolerate the wearing of negative pressure respirators.

B. "Surveillance and screening." Medical histories and laboratory examinations are required for each employee subject to exposure to DBCP. The employer should screen employees for history of certain medical conditions (listed below) which might place the employee at increased risk from exposure.

1. "Liver disease." The primary site of biotransformation and detoxification of DBCP is the liver. Liver dysfunctions likely to inhibit the conjugation reactions will tend to promote the toxic actions of DBCP. These precautions should be considered before exposing persons with impaired liver function to DBCP.

2. "Renal disease." Because DBCP has been associated with injury to the kidney it is important that special consideration be given to those with possible impairment of renal function.

3. "Skin disease." DBCP can penetrate the skin and can cause erythema on prolonged exposure. Persons with pre-existing skin disorders may be more susceptible to the effects of DBCP.

4. "Blood dyscrasias." DBCP has been shown to decrease the content of erythrocytes, hemoglobin, and leukocytes in the blood, as well as increase the prothrombin time. Persons with existing blood disorders may be more susceptible to the effects of DBCP.

5. "Reproductive disorders." Animal studies have associated DBCP with various effects on the reproductive organs. Among these effects are atrophy of the testicles and changes in the estrous cycle. Persons with pre-existing reproductive disorders may be at increased risk to these effects of DBCP.

"References"

1. Reznik, Ya. B. and Sprinchan, G. K.: Experimental Data on the Gonadotoxic effect of Nemagon, Gig. Sanit., (6), 1975, pp. 101-102, (translated from Russian).

2. Faydysh, E. V., Rakhmatullaev, N. N. and Varshavskii, V. A.: The Cytotoxic Action of Nemagon in a Subacute Experiment, Med. Zh. Uzbekistana, (No. 1), 1970, pp. 64-65, (translated from Russian).

3. Rakhmatullaev, N. N.: Hygienic Characteristics of the Nematocide Nemagon in Relation to Water Pollution Control, Hedge. Sanit., 36(3), 1971, pp. 344-348, (translated from Russian).

4. Olson, W. A. et al.: Induction of Stomach Cancer in Rats and Mice by Halogenated Aliphatic Fumigants, Journal of the National Cancer Institute, (51), 1973, pp. 1993-1995.

5. Torkelson, T. R. et al.: Toxicologic Investigations of 1, 2-Dibromo-3-chloropropane, Toxicology and Applied Pharmacology, 3, 1961 pp. 545-559.

[58 FR 35647, July 1, 1993]

1915.1045 Acrylonitrile.

(a) "Scope and application." (1) This section applies to all occupational exposures to acrylonitrile (AN), Chemical Abstracts Service Registry No. 000107131, except as provided in paragraphs (a)(2) and (a)(3) of this section.

(2) This section does not apply to exposures which result solely from the processing, use, and handling of the following materials:

(i) ABS resins, SAN resins, nitrile barrier resins, solid nitrile elastomers, and acrylic and modacrylic fibers, when these listed materials are in the form of finished polymers, and products fabricated from such finished polymers;

(ii) Materials made from and/or containing AN for which objective data is reasonably relied upon to demonstrate that the material is not capable of releasing AN in airborne concentrations in excess of 1 ppm as an eight (8)-hour time-weighted average, under the expected conditions of processing, use, and handling which will cause the greatest possible release; and

(iii) Solid materials made from and/or containing AN which will not be heated above 170 deg. F (77 deg. C) during handling, use, or processing.

(3) An employer relying upon exemption under paragraph (a)(2)(ii) shall maintain records of the objective data supporting that exemption, and of the basis of the employer's reliance on the data, as provided in paragraph (q) of this section.

(b) "Definitions." "Acrylonitrile" or "AN" means acrylonitrile monomer, chemical formula CH(2)=CHCN.

"Action level" means a concentration of AN of 1 ppm as an eight (8)-hour time-weighted average.

"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.

"Authorized person" means any person specifically authorized by the employer whose duties require the person to enter a regulated area, or any person entering such an area as a designated representative of employees for the purpose of exercising the opportunity to observe monitoring procedures under paragraph (r) of this section.

"Decontamination" means treatment of materials and surfaces by water washdown, ventilation, or other means, to assure that the materials will not expose employees to airborne concentrations of AN above 1 means the Director, National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee.

"Emergency" means any occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment, which results in an unexpected massive release of AN.

"Liquid AN" means AN monomer in liquid form, and liquid or semiliquid polymer intermediates, including slurries, suspensions, emulsions, and solutions, produced during the polymerization of AN.

"OSHA Area Office" means the Area Office of the Occupational Safety and Health Administration having jurisdiction over the geographic area where the affected workplace is located.

(c) "Permissible exposure limits" - (1) "Inhalation." (i) "Time weighted average limit (TWA)." The employer shall assure that no employee is exposed to an airborne concentration of acrylonitrile in excess of two (2) parts acrylonitrile per million parts of air (2 ppm) as an eight (8)-hour time-weighted average.

(ii) "Ceiling limit." The employer shall assure that no employee is exposed to an airborne concentration of acrylonitrile in excess of ten (10) ppm as averaged over any fifteen (15)-minute period during the work day.

(2) "Dermal and eye exposure." The employer shall assure that no employee is exposed to skin contact or eye contact with liquid AN.

(d) "Notification of regulated areas and emergencies" - (1) "Regulated areas." Within thirty (30) days following the establishment of a regulated area pursuant to paragraph (f) of this section, the employer shall report the following information to the OSHA Area Office:

(i) The address and location of each establishment which has one or more regulated areas;

(ii) The locations, within the establishment, of each regulated area;

(iii) A brief description of each process or operation which results in employee exposure to AN in regulated areas; and

(iv) The number of employees engaged in each process or operation within each regulated area which results in exposure to AN, and an estimate of the frequency and degree of exposure that occurs.

Whenever there has been a significant change in the information required to be reported by this paragraph, the employer shall promptly provide the new information to the OSHA Area Office.

(2) "Emergencies." Emergencies, and the facts obtainable at that time, shall be reported within seventy-two (72) hours of the initial occurrence to the OSHA Area Office. Upon request of the OSHA Area Office; the employer shall submit additional information in writing relevant to the nature and extent of employee exposures and measures taken to prevent future emergencies of a similar nature.

(ii) For the purposes of this section, employee exposure is that exposure which would occur if the employee were not using a respirator.

(2) "Initial monitoring." Each employer who has a place of employment in which AN is present shall monitor each such workplace and work operation to accurately determine the airborne concentrations of AN to which employees may be exposed.

(3) "Frequency." (i) If the monitoring required by this section reveals employee exposure to be below the action level, the employer may discontinue monitoring for that employee.

(ii) If the monitoring required by this section reveals employee exposure to be at or above the action level but below the permissible exposure limits, the employer shall repeat such monitoring for each such employee at least quarterly. The employer shall continue these quarterly measurements until at least two consecutive measurements taken at least seven (7) days apart, are below the action level, and thereafter the employer may discontinue monitoring for that employee.

(iii) If the monitoring required by this section reveals employee exposure to be in excess of the permissible exposure limits, the employer shall repeat these determinations for each such employee at least monthly. The employer shall continue these monthly measurements until at least two consecutive measurements, taken at least seven (7) days apart, are below the permissible exposure limits, and thereafter the employer shall monitor at least quarterly.

(4) "Additional monitoring." Whenever there has been a production, process, control, or personnel change which may result in new or additional exposures to AN, or whenever the employer has any other reason to suspect a change which may result in new or additional exposures to AN, additional monitoring which complies with this paragraph shall be conducted.

(5) "Employee notification." (i) Within five (5) working days after the receipt of the results of monitoring required by this paragraph, the employer shall notify each employee in writing of the results which represent that employee's exposure.

(ii) Whenever the results indicate that the representative employee exposure exceeds the permissible exposure limits, the employer shall include in the written notice a statement that the permissible exposure limits were exceeded and a description of the corrective action being taken to reduce exposure to or below the permissible exposure limits.

(6) "Accuracy of measurement." The method of measurement of employee exposures shall be accurate to a confidence level of 95 percent, to within plus or minus 35 percent for concentrations of AN at or above the permissible exposure limits, and plus or minus 50 percent for concentrations of AN below the permissible exposure limits.

(f) "Regulated areas." (1) The employer shall establish regulated areas where AN concentrations are in excess of the permissible exposure limits.

(2) Regulated areas shall be demarcated and segregated from the rest of the workplace, in any manner that minimizes the number of persons who will be exposed to AN.

(3) Access to regulated areas shall be limited to authorized persons or to persons otherwise authorized by the act or regulations issued pursuant thereto.

(4) The employer shall assure that food or beverages are not present or consumed, tobacco products are not present or used, and cosmetics are not applied in the regulated area.

(g) "Methods of compliance" - (1) "Engineering and work practice controls." (i) By November 2, 1980, the employer shall institute engineering and work practice controls to reduce and maintain employee exposures to AN, to or below the permissible exposure limits, except to the extent that the employer establishes that such controls are not feasible.

(ii) Wherever the engineering and work practice controls which can be instituted are not sufficient to reduce employee exposures to or below the permissible exposure limits, the employer shall nonetheless use them to reduce exposures to the lowest levels achievable by these controls, and shall supplement them by the use of respiratory protection which complies with the requirements of paragraph (h) of this section.

(2) "Compliance program." (i) The employer shall establish and implement a written program to reduce employee exposures to or below the permissible exposure limits solely by means of engineering and work practice controls, as required by paragraph (g)(1) of this section.

(ii) Written plans for these compliance programs shall include at least the following:

(A) A description of each operation or process resulting in employee exposure to AN above the permissible exposure limits;

(B) An outline of the nature of the engineering controls and work practices to be applied to the operation or process in question;

(D) A schedule for implementation of engineering and work practice controls for the operation or process, which shall project completion no later than November 2, 1980; and

(E) Other relevant information. (iii) The employer shall complete the steps set forth in the compliance program by the dates in the schedule.

(iv) Written plans shall be submitted upon request to the Assistant Secretary and the Director, and shall be available at the worksite for examination and copying by the Assistant Secretary, the Director, or any affected employee or representative.

(v) The plans required by this paragraph shall be revised and updated at least every six (6) months to reflect the current status of the program.

(h) "Respiratory protection" - (1) "General." The employer shall assure that respirators are used where required by this section to reduce employee exposure to within the permissible exposure limits. Respirators shall be used in the following circumstances:

(i) During the time period necessary to install or implement feasible engineering and work practice controls;

(ii) In work operations, such as maintenance and repair activities or reactor cleaning, in which the employer establishes that engineering and work practice controls are not feasible;

(iii) In work situations where feasible engineering and work practice controls are not yet sufficient to reduce exposure to or below the permissible exposure limits; and

(iv) In emergencies.

(2) "Respirator selection." (i) Where respiratory protection is required under this section, the employer shall select and provide, at no cost to the employee, the appropriate type of respirator from table I below, and shall assure that the employee wears the respirator provided.

TABLE I - RESPIRATORY PROTECTION FOR ACRYLONITRILE (AN)
Concentration of AN or condition of use	Respirator type
(a) Less than or equal to 20 ppm.	(1) Chemical cartridge respirator with organic vapor cartridge(s) and half-mask facepiece; or (2) Supplied air respirator with half-mask facepiece
(b) Less than or equal to 100 ppm or maximum use concentration (MUC) of cartridges or canisters, whichever is lower	(1) Full facepiece respirator with (A) organic vapor cartridges, (B) organic vapor gas mask chin-style, or (C) organic vapor gas mask canister, front- or back-mounted; (2) Supplied air respirator with full facepiece; or (3) Self-contained breathing apparatus with full facepiece
(c) Less than or equal to 4,000 ppm.	(1) Supplied air respirator operated in the positive pressure mode with full facepiece, helmet, suit, or hood
(d) Greater than 4,000 ppm or unknown concentration	(1) Supplied air and auxiliary self-contained breathing apparatus with full facepiece in positive pressure mode; or (2) Self-contained breathing apparatus with full facepiece in positive pressure mode
(e) Firefighting	Self-contained breathing apparatus with full facepiece in positive pressure mode
(f) Escape	(1) Any organic vapor respirator, or (2) Any self-contained breathing apparatus

(ii) The employer shall select respirators from among those approved for use with organic vapors by the National Institute for Occupational Safety and Health under the provisions of 30 CFR part 11.

(3) "Respirator program." (i) The employer shall institute a respiratory protection program in accordance with 29 CFR 1910.134(b), (d), (e), and (f).

(ii) Where air/purifying respirators (chemical cartridge- or canister-type) are used, the air-purifying canister or cartridge(s) shall be replaced prior to the expiration of their service life or at the completion of each shift, whichever occurs first. A label shall be attached to the cartridge or canister to indicate the date and time at which it is first installed on the respirator.

(iii) "Testing." Fit testing of respirators shall be performed to assure that the respirator selected provides the protection required by table I.

(A) "Qualitative fit." The employer shall perform qualitative fit tests at the time of initial fitting and at least semiannually thereafter for each employee wearing respirators.

(B) "Quantitative fit." Each employer with more than 10 employees wearing negative pressure respirators shall perform quantitative fit testing at the time of initial fitting and at least semiannually thereafter for each such employee.

(iv) Employees who wear respirators shall be allowed to wash their faces and to wipe clean the face-to-facepiece seals on their respirators to minimize potential skin irritation associated with respirator use.

(i) "Emergency situations" - (1) "Written plans." (i) A written plan for emergency situations shall be developed for each workplace where liquid AN is present. Appropriate portions of the plan shall be implemented in the event of an emergency.

(ii) The plan shall specifically provide that employees engaged in correcting emergency conditions shall be equipped as required in paragraph (h) of this section until the emergency is abated.

(iii) Employees not engaged in correcting the emergency shall be evacuated from the area and shall not be permitted to return until the emergency is abated.

(2) "Alerting employees." Where there is the possibility of employee exposure to AN in excess of the ceiling limit, a general alarm shall be installed and used to promptly alert employees of such occurrences.

(j) "Protective clothing and equipment" - (1) "Provision and use." Where eye or skin contact with liquid AN may occur, the employer shall provide at no cost to the employee, and assure that employees wear, impermeable protective clothing or other equipment to protect any area of the body which may come in contact with liquid AN. The provision of 1910.132 and 1910.133 shall be complied with.

(2) "Cleaning and replacement." (i) The employer shall clean, launder, maintain, or replace protective clothing and equipment required by this section as needed to maintain their effectiveness.

(ii) The employer shall assure that impermeable protective clothing which contacts or is likely to have contacted liquid AN shall be decontaminated before being removed by the employee.

(iii) The employer shall assure that an employee whose nonimpermeable clothing becomes wetted with liquid AN shall immediately remove that clothing and proceed to shower. The clothing shall be decontaminated before it is removed from the regulated area.

(iv) The employer shall assure that no employee removes protective clothing or equipment from the change room, except for those employees authorized to do so for the purpose of laundering, maintenance, or disposal.

(v) The employer shall inform any person who launders or cleans protective clothing or equipment of the potentially harmful effects of exposure to AN.

(k) "Housekeeping." (1) All surfaces shall be maintained free of visible accumulations of liquid AN.

(2) For operations involving liquid AN, the employer shall institute a program for detecting leaks and spills of liquid AN, including regular visual inspections.

(3) Where spills of liquid AN are detected, the employer shall assure that surfaces contacted by the liquid AN are decontaminated. Employees not engaged in decontamination activities shall leave the area of the spill, and shall not be permitted in the area until decontamination is completed.

(l) "Waste disposal." AN waste, scrap, debris, bags, containers, or equipment shall be decontaminated before being incorporated in the general waste disposal system.

(m) "Hygiene facilities and practices." (1) Where employees are exposed to airborne concentrations of AN above the permissible exposure limits, or where employees are required to wear protective clothing or equipment pursuant to paragraph (j) of this section, the facilities required by 29 CFR 1910.141, including clean change rooms and shower facilities, shall be provided by the employer for the use of those employees, and the employer shall assure that the employees use the facilities provided.

(2) The employer shall assure that employees wearing protective clothing or equipment for protection from skin contact with liquid AN shall shower at the end of the work shift.

(3) The employer shall assure that, in the event of skin or eye exposure to liquid AN, the affected employee shall shower immediately to minimize the danger of skin absorption.

(4) The employer shall assure that employees working in the regulated area wash their hands and faces prior to eating.

(n) "Medical surveillance" - (1) "General." (i) The employer shall institute a program of medical surveillance for each employee who is or will be exposed to AN at or above the action level, without regard to the use of respirators. The employer shall provide each such employee with an opportunity for medical examinations and tests in accordance with this paragraph.

(ii) The employer shall assure that all medical examinations and procedures are performed by or under the supervision of a licensed physician, and that they shall be provided without cost to the employee.

(2) "Initial examinations." At the time of initial assignment, or upon institution of the medical surveillance program, the employer shall provide each affected employee an opportunity for a medical examination, including at least the following elements:

(i) A work history and medical history with special attention to skin, respiratory, and gastrointestinal systems, and those nonspecific symptoms, such as headache, nausea, vomiting, dizziness, weakness, or other central nervous system dysfunctions that may be associated with acute or with chronic exposure to AN;

(ii) A complete physical examination giving particular attention to the peripheral and central nervous system, gastrointestinal system, respiratory system, skin, and thyroid;

(iii) A 14- by 17-inch posteroanterior chest X-ray; and

(iv) Further tests of the intestinal tract, including fecal occult blood screening, for all workers 40 years of age or older, and for any other affected employees for whom, in the opinion of the physician, such testing is appropriate.

(3) "Periodic examinations." (i) The employer shall provide the examinations specified in paragraph (n)(2) of this section at least annually for all employees specified in paragraph (n)(1) of this section.

(ii) If an employee has not had the examination specified in paragraph (n)(2) of this section within 6 months preceding termination of employment,the employer shall make such examination available to the employee prior to such termination.

(4) "Additional examinations." If the employee for any reason develops signs or symptoms which may be associated with exposure to AN, the employer shall provide an appropriate examination and emergency medical treatment.

(5) "Information provided to the physician." The employer shall provide the following information to the examining physician:

(i) A copy of this standard and its appendixes;

(ii) A description of the affected employee's duties as they relate to the employee's exposure;

(iii) The employee's representative exposure level;

(iv) The employee's anticipated or estimated exposure level (for preplacement examinations or in cases of exposure due to an emergency);

(v) A description of any personal protective equipment used or to be used; and

(vi) Information from previous medical examinations of the affected employee, which is not otherwise available to the examining physician.

(6) "Physician's written opinion." (i) The employer shall obtain a written opinion from the examining physician which shall include:

(A) The results of the medical examination and test performed;

(B) The physician's opinion as to whether the employee has any detected medical condition(s) which would place the employee at an increased risk of material impairment of the employee's health from exposure to AN;

(C) Any recommended limitations upon the employee's exposure to AN or upon the use of protective clothing and equipment such as respirators; and (D) A statement that the employee has been informed by the physician of the results of the medical examination and any medical conditions which require further examination or treatment.

(ii) The employer shall instruct the physician not to reveal in the written opinion specific findings or diagnoses unrelated to occupational exposure to AN.

(iii) The employer shall provide a copy of the written opinion to the affected employee.

(o) "Employee information and training" - (1) "Training program." (i) By January 2, 1979, the employer shall institute a training program for and assure the participation of all employees exposed to AN above the action level, all employees whose exposures are maintained below the action level by engineering and work practice controls, and all employees subject to potential skin or eye contact with liquid AN.

(ii) Training shall be provided at the time of initial assignment, or upon institution of the training program, and at least annually thereafter, and the employer shall assure that each employee is informed of the following:

(A) The information contained in appendixes A and B;

(B) The quantity, location, manner of use, release, or storage of AN, and the specific nature of operations which could result in exposure to AN, as well as any necessary protective steps;

(D) The purpose and a description of the medical surveillance program required by paragraph (n) of this section;

(E) The emergency procedures developed, as required by paragraph (i) of this section;

(F) Engineering and work practice controls, their function, and the employee's relationship to these controls; and

(G) A review of this standard.

(2) "Access to training materials."

(i) The employer shall make a copy of this standard and its appendixes readily available to all affected employees.

(ii) The employer shall provide, upon request, all materials relating to the employee information and training program to the Assistant Secretary and the Director.

(ii) The employer shall assure that no statement appears on or near any sign or label required by this paragraph which contradicts or detracts from the required sign or label.

(2) "Signs." (i) The employer shall post signs to clearly indicate all workplaces where AN concentrations exceed the permissible exposure limits. The signs shall bear the following legend:

DANGER
ACRYLONITRILE (AN)
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS MAY BE REQUIRED

(ii) The employer shall assure that signs required by this paragraph are illuminated and cleaned as necessary so that the legend is readily visible.

(3) "Labels." (i) The employer shall assure that precautionary labels are affixed to all containers of liquid AN and AN-based materials not exempted under paragraph (a)(2) of this standard. The employer shall assure that the labels remain affixed when the materials are sold, distributed, or otherwise leave the employer's workplace.

(ii) The employer shall assure that the precautionary labels required by this paragraph are readily visible and legible. The labels shall bear the following legend:

DANGER
CONTAINS ACRYLONITRILE (AN)
CANCER HAZARD

(q) "Recordkeeping" - (1) "Objective data for exempted operations." (i) Where the processing, use, and handling of materials made from or containing AN are exempted pursuant to paragraph (a)(2)(ii) of this section, the employer shall establish and maintain an accurate record of objective data reasonably relied upon in support of the exemption.

(ii) This record shall include at least the following information:

(A) The material qualifying for exemption;

(B) The source of the objective data;

(D) A description of the operation exempted and how the data supports the exemption; and

(E) Other data relevant to the operations, materials, and processing covered by the exemption.

(iii) The employer shall maintain this record for the duration of the employer's reliance upon such objective data.

(2) "Exposure monitoring." (i) The employer shall establish and maintain an accurate record of all monitoring required by paragraph (e) of this section.

(ii) This record shall include:

(A) The dates, number, duration, and results of each of the samples taken, including a description of the sampling procedure used to determine representative employee exposure;

(B) A description of the sampling and analytical methods used and the data relied upon to establish that the methods used meet the accuracy and precision requirements of paragraph (e)(6) of this section;

(D) Name, social security number, and job classification of the employee monitored and of all other employees whose exposure the measurement is intended to represent.

(iii) The employer shall maintain this record for at least forty (40) years, or for the duration of employment plus twenty (20) years, whichever is longer.

(3) "Medical surveillance." (i) The employer shall establish and maintain an accurate record for each employee subject to medical surveillance as required by paragraph (n) of this section.

(ii) This record shall include:

(A) A copy of the physician's written opinions;

(B) Any employee medical complaints related to exposure to AN;

(D) A copy of the employee's medical and work history.

(iii) The employer shall assure that this record be maintained for at least forty (40) years, or for the duration of employment plus twenty (20) years, whichever is longer.

(4) "Availability." (i) The employer shall make all records required to be maintained by this section available, upon request, to the Assistant Secretary and the Director for examination and copying.

(ii) Records required by paragraphs (q)(1) through (q)(3) of this section shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1915.1120(a) through (e) and (q) through (i). Records required by paragraph (q)(1) shall be provided in the same manner as exposure monitoring records.

(5) "Transfer of records." (i) Whenever the employer ceases to do business,the successor employer shall receive and retain all records required to be maintained by this section for the prescribed period.

(ii) Whenever the employer ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, these records shall be transmitted to the Director.

(iii) At the expiration of the retention period for the records required to be maintained pursuant to this section, the employer shall notify the Director at least 3 months prior to the disposal of the records, and shall transmit them to the Director upon request.

(iv) The employer shall also comply with any additional requirements involving transfer of records set forth in 29 CFR 1915.1120(h).

(r) "Observation of monitoring" - (1) "Employee observation." The employer shall provide affected employees, or their designated representatives, an opportunity to observe any monitoring of employee exposure to AN conducted pursuant to paragraph (e) of this section.

(2) "Observation procedures." (i) Whenever observation of the monitoring of employee exposure to AN requires entry into an area where the use of protective clothing or equipment is required, the employer shall provide the observer with personal protective clothing and equipment required to be worn by employees working in the area, assure the use of such clothing and equipment, and require the observer to comply with all other applicable safety and health procedures.

(ii) Without interfering with the monitoring, observers shall be entitled:

(A) To receive an explanation of the measurement procedures;

(B) To observe all steps related to the measurement of airborne concentrations of AN performed at the place of exposure; and

(2) Monitoring and medical surveillance conducted since January 17, 1978, under the provisions of the emergency temporary standard may be relied upon by the employer to meet the initial monitoring and initial medical surveillance requirements of this section.

(3) Training programs must be implemented by January 2, 1979.

(4) Engineering and work practice controls required by paragraph (g) of this section shall be implemented no later than November 2, 1980.

(t) "Appendixes." The information contained in the appendixes is not intended, by itself, to create any additional obligation not otherwise imposed, or to detract from any obligation.

(Approved by the Office of Management and Budget under control number 1218-0126)

[58 FR 35310, July 1, 1993]

1915.1045 Appendix A Substance safety data sheet for acrylonitrile.

I. "Substance Identification"

A. Substance: Acrylonitrile (CH(2) CHCN).

B. Synonyms: Propenenitrile; vinyl cyanide; cyanoethylene; AN; VCN; acylon; carbacryl; fumigrian; ventox.

C. Acrylonitrile can be found as a liquid or vapor, and can also be found in polymer resins, rubbers, plastics, polyols, and other polymers having acrylonitrile as a raw or intermediate material.

D. AN is used in the manufacture of acrylic and modiacrylic fibers, acrylic plastics and resins, speciality polymers, nitrile rubbers, and other organic chemicals. It has also been used as a fumigant.

E. Appearance and odor: Colorless to pale yellow liquid with a pungent odor which can only be detected at concentrations above the permissible exposure level, in a range of 13-19 parts AN per million parts of air (13-19 ppm).

F. Permissible exposure: Exposure may not exceed either:

1. Two parts AN per million parts of air (2 ppm) averaged over the 8-hour workday; or

2. Ten parts AN per million parts of air (10 ppm) averaged over any 15-minute period in the workday.

3. In addition, skin and eye contact with liquid AN is prohibited.

II. "Health Hazard Data"

A. Acrylonitrile can affect your body if you inhale the vapor (breathing), if it comes in contact with your eyes or skin, or if you swallow it. It may enter your body through your skin.

B. Effects of overexposure: 1. Short-term exposure: Acrylonitrile can cause eye irritation, nausea, vomiting, headache, sneezing, weakness, and lightheadedness. At high concentrations, the effects of exposure may go on to loss of consciousness and death. When acrylonitrile is held in contact with the skin after being absorbed into shoe leather or clothing, it may produce blisters following several hours of no apparent effect. Unless the shoes or clothing are removed immediately and the area washed, blistering will occur. Usually there is no pain or inflammation associated with blister formation.

2. Long-term exposure: Acrylonitrile has been shown to cause cancer in laboratory animals and has been associated with higher incidences of cancer in humans. Repeated or prolonged exposure of the skin to acrylonitrile may produce irritation and dermatitis.

3. Reporting signs and symptoms: You should inform your employer if you develop any signs or symptoms and suspect they are caused by exposure to acrylonitrile.

III. "Emergency First Aid Procedures"

A. Eye exposure: If acrylonitrile gets into your eyes, wash your eyes immediately with large amounts of water, lifting the lower and upper lids occasionally. Get medical attention immediately. Contact lenses should not be worn when working with this chemical.

B. Skin exposure: If acrylonitrile gets on your skin, immediately wash the contaminated skin with water. If acrylonitrile soaks through your clothing, especially your shoes, remove the clothing immediately and wash the skin with water. If symptoms occur after washing, get medical attention immediately. Thoroughly wash the clothing before reusing. Contaminated leather shoes or other leather articles should be discarded.

C. Inhalation: If you or any other person breathes in large amounts of acrylonitrile, move the exposed person to fresh air at once. If breathing has stopped, perform artificial respiration. Keep the affected person warm and at rest. Get medical attention as soon as possible.

D. Swallowing: When acrylonitrile has been swallowed, give the person large quantities of water immediately. After the water has been swallowed, try to get the person to vomit by having him touch the back of his throat with his finger. Do not make an unconscious person vomit. Get medical attention immediately.

E. Rescue: Move the affected person from the hazardous exposure. If the exposed person has been overcome, notify someone else and put into effect the established emergency procedures. Do not become a casualty yourself. Understand your emergency rescue procedures and know the location of the emergency equipment before the need arises.

F. Special first aid procedures: First aid kits containing an adequate supply (at least two dozen) of amyl nitrite pearls, each containing 0.3 ml,should be maintained at each site where acrylonitrile is used. When a person is suspected of receiving an overexposure to acrylonitrile, immediately remove that person from the contaminated area using established rescue procedures. Contaminated clothing must be removed and the acrylonitrile washed from the skin immediately. Artificial respiration should be started at once if breathing has stopped. If the person is unconscious, amyl nitrite may be used as an antidote by a properly trained individual in accordance with established emergency procedures. Medical aid should be obtained immediately.

IV. "Respirators and Protective Clothing"

A. Respirators. You may be required to wear a respirator for nonroutine activities, in emergencies, while your employer is in the process of reducing acrylonitrile exposures through engineering controls, and in areas where engineering controls are not feasible. If respirators are worn,they must have a Mine Safety and Health Administration (MSHA or MESA) or National Institute for Occupational Safety and Health (NIOSH) label of approval for use with organic vapors. (Older respirators may have a Bureau of Mines approval label.) For effective protection, respirators must fit your face and head snugly. Respirators should not be loosened or removed in work situations where their use is required.

Acrylonitrile does not have a detectable odor except at levels above the permissible exposure limits. Do not depend on odor to warn you when a respirator cartridge or canister is exhausted. Cartridges or canisters must be changed daily or before the end-of-service-life, whichever comes first. Reuse of these may allow acrylonitrile to gradually filter through the cartridge and cause exposures which you cannot detect by odor. If you can smell acrylonitrile while wearing a respirator, proceed immediately to fresh air. If you experience difficulty breathing while wearing a respirator, tell your employer.

B. Supplied-air suits: In some work situations, the wearing of supplied-air suits may be necessary. Your employer must instruct you in their proper use and operation.

C. Protective clothing: You must wear impervious clothing, gloves, face shield, or other appropriate protective clothing to prevent skin contact with liquid acrylonitrile. Where protective clothing is required, your employer is required to provide clean garments to you as necessary to assume that the clothing protects you adequately.

Replace or repair impervious clothing that has developed leaks. Acrylonitrile should never be allowed to remain on the skin. Clothing and shoes which are not impervious to acrylonitrile should not be allowed to become contaminated with acrylonitrile, and if they do the clothing and shoes should be promptly removed and decontaminated. The clothing should be laundered or discarded after the AN is removed. Once acrylonitrile penetrates shoes or other leather articles, they should not be worn again.

D. Eye protection: You must wear splashproof safety goggles in areas where liquid acrylonitrile may contact your eyes. In addition, contact lenses should not be worn in areas where eye contact with acrylonitrile can occur.

V. "Precautions for Safe Use, Handling, and Storage"

A. Acrylonitrile is a flammable liquid, and its vapors can easily form explosive mixtures in air.

B. Acrylonitrile must be stored in tightly closed containers in a cool, well-ventilated area, away from heat, sparks, flames, strong oxidizers (especially bromine), strong bases, copper, copper alloys, ammonia, and amines.

C. Sources of ignition such as smoking and open flames are prohibited wherever acrylonitrile is handled, used, or stored in a manner that could create a potential fire or explosion hazard.

D. You should use non-sparking tools when opening or closing metal containers of acrylonitrile, and containers must be bonded and grounded when pouring or transferring liquid acrylonitrile.

E. You must immediately remove any non-impervious clothing that becomes wetted with acrylonitrile, and this clothing must not be reworn until the acrylonitrile is removed from the clothing.

F. Impervious clothing wet with liquid acrylonitrile can be easily ignited. This clothing must be washed down with water before you remove it.

G. If your skin becomes wet with liquid acrylonitrile, you must promptly and thoroughly wash or shower with soap or mild detergent to remove any acrylonitrile from your skin.

H. You must not keep food, beverages, or smoking materials, nor are you permitted to eat or smoke in regulated areas where acrylonitrile concentrations are above the permissible exposure limits.

I. If you contact liquid acrylonitrile, you must wash your hands thoroughly with soap or mild detergent and water before eating, smoking, or using toilet facilities.

J. Fire extinguishers and quick drenching facilities must be readily available, and you should know where they are and how to operate them.

K. Ask your supervisor where acrylonitrile is used in your work area and for any additional plant safety and health rules.

VI. "Access to Information"

A. Each year, your employer is required to inform you of the information contained in this Substance Safety Data Sheet for acrylonitrile. In addition, you employer must instruct you in the proper work practices for using acrylonitrile, emergency procedures, and the correct use of protective equipment.

B. Your employer is required to determine whether you are being exposed to acrylonitrile. You or your representative has the right to observe employee measurements and to record the results obtained. Your employer is required to inform you of your exposure. If your employer determines that you are being overexposed, he or she is required to inform you of the actions which are being taken to reduce your exposure to within permissible exposure limits.

C. Your employer is required to keep records of your exposures and medical examinations. These records must be kept by the employer for at least forty (40) years or for the period of your employment plus twenty (20) years, whichever is longer.

D. Your employer is required to release your exposure and medical records to you or your representative upon your request.

[58 FR 35652, July 1, 1993]

1915.1045 Appendix B Substance technical guidelines for acrylonitrile

I. "Physical and Chemical Data"

A. Substance identification: 1. Synonyms: AN; VCN; vinyl cyanide; propenenitrile; cyanoethylene; Acrylon; Carbacryl; Fumigrain; Ventox. 2. Formula: CH(2=CHCN). 3. Molecular weight: 53.1.

B. Physical data: 1. Boiling point (760 mm Hg): 77.3 deg. C (171 deg. F); 2. Specific gravity (water = 1): 0.81 (at 20 deg. C or 68 deg. F); 3. Vapor density (air=1 at boiling point of acrylonitrile): 1.83; 4. Melting point: -83 deg. C (-117 deg. F); 5. Vapor pressure (at 20 deg. F): 83 mm Hg; 6. Solubility in water, percent by weight at 20 deg. C (68 deg. F): 7.35; 7. Evaporation rate (Butyl Acetate = 1): 4.54; and 8. Appearance and odor: Colorless to pale yellow liquid with a pungent odor at concentrations above the permissible exposure level. Any detectable odor of acrylonitrile may indicate overexposure.

II. "Fire, Explosion, and Reactivity Hazard Data"

A. Fire: 1. Flash point: -1 deg. C (30 deg. F) (closed cup). 2. Autoignition temperature: 481 deg. C (898 deg. F). 3. Flammable limits air, percent by volume: Lower: 3, Upper: 17. 4. Extinguishing media: Alcohol foam, carbon dioxide, and dry chemical. 5. Special fire-fighting procedures: Do not use a solid stream of water, since the stream will scatter and spread the fire. Use water to cool containers exposed to a fire.

6. Unusual fire and explosion hazards: Acrylonitrile is a flammable liquid. Its vapors can easily form explosive mixtures with air. All ignition sources must be controlled where acrylonitrile is handled, used, or stored in a manner that could create a potential fire or explosion hazard. Acrylonitrile vapors are heavier than air and may travel along the ground and be ignited by open flames or sparks at locations remote from the site at which acrylonitrile is being handled.

7. For purposes of compliance with the requirements of 29 CFR 1910.106, acrylonitrile is classified as a class IB flammable liquid. For example, 7,500 ppm, approximately one-fourth of the lower flammable limit, would be considered to pose a potential fire and explosion hazard.

8. For purposes of compliance with 29 CFR 1910.157, acrylonitrile is classified as a Class B fire hazard.

9. For purpose of compliance with 29 CFR 1919.309, locations classified as hazardous due to the presence of acrylonitrile shall be Class I, Group D.

B. Reactivity:

1. Conditions contributing to instability: Acrylonitrile will polymerize when hot, and the additional heat liberated by the polymerization may cause containers to explode. Pure AN may self-polymerize, with a rapid build-up of pressure, resulting in an explosion hazard. Inhibitors are added to the commercial product to prevent self-polymerization.

2. Incompatibilities: Contact with strong oxidizers (especially bromine) and strong bases may cause fires and explosions. Contact with copper, copper alloys, ammonia, and amines may start serious decomposition.

3. Hazardous decomposition products: Toxic gases and vapors (such as hydrogen cyanide, oxides of nitrogen, and carbon monoxide) may be released in a fire involving acrylonitrile and certain polymers made from acrylonitrile.

4. Special precautions: Liquid acrylonitrile will attack some forms of plastics, rubbers, and coatings.

III. "Spill, Leak, and Disposal Procedures"

A. If acrylonitrile is spilled or leaked, the following steps should be taken:

1. Remove all ignition sources.

2. The area should be evacuated at once and re-entered only after the area has been thoroughly ventilated and washed down with water.

3. If liquid acrylonitrile or polymer intermediate, collect for reclamation or absorb in paper, vermiculite, dry sand, earth, or similar material, or wash down with water into process sewer system.

B. Persons not wearing protective equipment should be restricted from areas of spills or leaks until clean-up has been completed.

C. Waste disposal methods: Waste material shall be disposed of in a manner that is not hazardous to employees or to the general population. Spills of acrylonitrile and flushing of such spills shall be channeled for appropriate treatment or collection for disposal. They shall not be channeled directly into the sanitary sewer system. In selecting the method of waste disposal, applicable local, State, and Federal regulations should be consulted.

IV. "Monitoring and Measurement Procedures"

A. Exposure above the Permissible Exposure Limit:

1. Eight-hour exposure evaluation: Measurements taken for the purpose of determining employee exposure under this section are best taken so that the average 8-hour exposure may be determined from a single 8-hour sample or two (2) 4-hour samples. Air samples should be taken in the employee's breathing zone (air that would most nearly represent that inhaled by the employee.) 2. Ceiling evaluation: Measurements taken for the purpose of determining employee exposure under this section must be taken during periods of maximum expected airborne concentrations of acrylonitrile in the employee's breathing zone. A minimum of three (3) measurements should be taken on one work shift. The average of all measurements taken is an estimate of the employee's ceiling exposure.

3. Monitoring techniques: The sampling and analysis under this section may be performed by collecting the acrylonitrile vapor on charcoal adsorption tubes or other composition adsorption tubes, with subsequent chemical analysis. Sampling and analysis may also be performed by instruments such as real-time continuous monitoring systems, portable direct-reading instruments, or passive dosimeters. Analysis of resultant samples should be by gas chromatograph.

Appendix D lists methods of sampling and analysis which have been tested by NIOSH and OSHA for use with acrylonitrile. NIOSH and OSHA have validated modifications of NIOSH Method S-156 (See Appendix D) under laboratory conditions for concentrations below 1 ppm. The employer has the obligation of selecting a monitoring method which meets the accuracy and precision requirements of the standard under his unique field conditions. The standard requires that methods of monitoring must be accurate, to a 95-percent confidence level, to + or - 35-percent for concentrations of AN at or above 2 ppm, and to + or - 50-percent for concentrations below 2 ppm. In addition to the methods described in Appendix D, there are numerous other methods available for monitoring for AN in the workplace. Details on these other methods have been submitted by various companies to the rulemaking record, and are available at the OSHA Docket Office.

B. Since many of the duties relating to employee exposure are dependent on the results of monitoring and measuring procedures, employers shall assure that the evaluation of employee exposures is performed by a competent industrial hygienist or other technically qualified person.

V. "Protective Clothing"

Employees shall be provided with and required to wear appropriate protective clothing to prevent any possibility of skin contact with liquid AN. Because acrylonitrile is absorbed through the skin, it is important to prevent skin contact with liquid AN. Protective clothing shall include impermeable coveralls or similar full-body work clothing, gloves, head-coverings, as appropriate to protect areas of the body which may come in contact with liquid AN.

Employers should ascertain that the protective garments are impermeable to acrylonitrile. Non-impermeable clothing and shoes should not be allowed to become contaminated with liquid AN. If permeable clothing does become contaminated, it should be promptly removed, placed in a regulated area for removal of the AN, and not worn again until the AN is removed. If leather footwear or other leather garments become wet from acrylonitrile, they should be replaced and not worn again, due to the ability of leather to absorb acrylonitrile and hold it against the skin. Since there is no pain associated with the blistering which may result from skin contact with liquid AN, it is essential that the employee be informed of this hazard so that he or she can be protected.

Any protective clothing which has developed leaks or is otherwise found to be defective shall be repaired or replaced. Clean protective clothing shall be provided to the employee as necessary to assure its protectiveness. Whenever impervious clothing becomes wet with liquid AN, it shall be washed down with water before being removed by the employee. Employees are also required to wear splash-proof safety goggles where there is any possibility of acrylonitrile contacting the eyes.

VI. "Housekeeping and Hygiene Facilities"

For purposes of complying with 29 CFR 1910.141, the following items should be emphasized:

A. The workplace should be kept clean, orderly, and in a sanitary condition. The employer is required to institute a leak and spill detection program for operations involving liquid AN in order to detect sources of fugitive AN emissions.

B. Dry sweeping and the use of compressed air is unsafe for the cleaning of floors and other surfaces where liquid AN may be found.

C. Adequate washing facilities with hot and cold water are to be provided, and maintained in a sanitary condition. Suitable cleansing agents are also to be provided to assure the effective removal of acrylonitrile from the skin.

D. Change or dressing rooms with individual clothes storage facilities must be provided to prevent the contamination of street clothes with acrylonitrile. Because of the hazardous nature of acrylonitrile, contaminated protective clothing should be placed in a regulated area designated by the employer for removal of the AN before the clothing is laundered or disposed of.

VII. "Miscellaneous Precautions"

A. Store acrylonitrile in tightly-closed containers in a cool, well-ventilated area and take necessary precautions to avoid any explosion hazard.

B. High exposures to acrylonitrile can occur when transferring the liquid from one container to another.

C. Non-sparking tools must be used to open and close metal acrylonitrile containers. These containers must be effectively grounded and bonded prior to pouring.

D. Never store uninhibited acrylonitrile.

E. Acrylonitrile vapors are not inhibited. They may form polymers and clog vents of storage tanks.

F. Use of supplied-air suits or other impervious coverings may be necessary to prevent skin contact with and provide respiratory protection from acrylonitrile where the concentration of acrylonitrile is unknown or is above the ceiling limit. Supplied-air suits should be selected, used, and maintained under the immediate supervision of persons knowledgeable in the limitations and potential life-endangering characteristics of supplied-air suits.

G. Employers shall advise employees of all areas and operations where exposure to acrylonitrile could occur.

VIII. "Common Operations"

Common operations in which exposure to acrylonitrile is likely to occur include the following: Manufacture of the acrylonitrile monomer; synthesis of acrylic fibers, ABS, SAN, and nitrile barrier plastics and resins, nitrile rubber, surface coatings, specialty chemicals, use as a chemical intermediate, use as a fumigant and in the cyanoethylation of cotton.

[58 FR 35654, July 1, 1993]

1915.1045 Appendix C Medical surveillance guidelines for acrylonitrile.

I. "Route of Entry"

Inhalation; skin absorption; ingestion.

II. "Toxicology"

Acrylonitrile vapor is an asphyxiant due to inhibitory action on metabolic enzyme systems. Animals exposed to 75 or 100 ppm for 7 hours have shown signs of anoxia; in some animals which died at the higher level, cyanomethemoglobin was found in the blood. Two human fatalities from accidental poisoning have been reported; one was caused by inhalation of an unknown concentration of the vapor, and the other was thought to be caused by skin absorption or inhalation. Most cases of intoxication from industrial exposure have been mild, with rapid onset of eye irritation, headache, sneezing, and nausea. Weakness, lightheadedness, and vomiting may also occur. Exposure to high concentrations may produce profound weakness, asphyxia, and death. The vapor is a severe eye irritant. Prolonged skin contract with the liquid may result in absorption with systemic effects, and in the formation of large blisters after a latent period of several hours. Although there is usually little or no pain or inflammation, the affected skin resembles a second-degree thermal burn. Solutions spilled on exposed skin, or on areas covered only by a light layer of clothing, evaporate rapidly, leaving no irritation, or, at the most, mild transient redness. Repeated spills on exposed skin may result in dermatitis due to solvent effects.

Results after 1 year of a planned 2-year animal study on the effects of exposure to acrylonitrile have indicated that rats ingesting as little as 35 ppm in their drinking water develop tumors of the central nervous system. The interim results of this study have been supported by a similar study being conducted by the same laboratory, involving exposure of rats by inhalation of acrylonitrile vapor, which has shown similar types of tumors in animals exposed to 80 ppm.

In addition, the preliminary results of an epidemiological study being performed by duPont on a cohort of workers in their Camden, S.C. acrylic fiber plant indicate a statistically significant increase in the incidence of colon and lung cancers among employees exposed to acrylonitrile.

III. "Signs and Symptoms of Acute Overexposure"

Asphyxia and death can occur from exposure to high concentrations of acrylonitrile. Symptoms of overexposure include eye irritation, headache, sneezing, nausea and vomiting, weakness, and lightheadedness. Prolonged skin contact can cause blisters on the skin with appearance of a second-degree burn, but with little or no pain. Repeated skin contact may produce scaling dermatitis.

IV. "Treatment of Acute Overexposure"

Remove employee from exposure. Immediately flush eyes with water and wash skin with soap or mild detergent and water. If AN has been swallowed, and person is conscious, induce vomiting. Give artificial resuscitation if indicated. More severe cases, such as those associated with loss of consciousness, may be treated by the intravenous administration of sodium nitrite, followed by sodium thiosulfate, although this is not as effective for acrylonitrile poisoning as for inorganic cyanide poisoning.

V. "Surveillance and Preventive Considerations"

A. As noted above, exposure to acrylonitrile has been linked to increased incidence of cancers of the colon and lung in employees of the duPont acrylic fiber plant in Camden, S.C. In addition, the animal testing of acrylonitrile has resulted in the development of cancers of the central nervous system in rats exposed by either inhalation or ingestion. The physician should be aware of the findings of these studies in evaluating the health of employees exposed to acrylonitrile.

Most reported acute effects of occupational exposure to acrylonitrile are due to its ability to cause tissue anoxia and asphyxia. The effects are similar to those caused by hydrogen cyanide. Liquid acrylonitrile can be absorbed through the skin upon prolonged contact. The liquid readily penetrates leather, and will produce burns of the feet if footwear contaminated with acrylonitrile is not removed.

It is important for the physician to become familiar with the operating conditions in which exposure to acrylonitrile may occur. Those employees with skin diseases may not tolerate the wearing of whatever protective clothing may be necessary to protect them from exposure. In addition, those with chronic respiratory disease may not tolerate the wearing of negative-pressure respirators.

B. Surveillance and screening. Medical histories and laboratory examinations are required for each employee subject to exposure to acrylonitrile above the action level. The employer must screen employees for history of certain medical conditions which might place the employee at increased risk from exposure.

1. "Central nervous system dysfunction." Acute effects of exposure to acrylonitrile generally involve the central nervous system. Symptoms of acrylonitrile exposure include headache, nausea, dizziness, and general weakness. The animal studies cited above suggest possible carcinogenic effects of acrylonitrile on the central nervous system, since rats exposed by either inhalation or ingestion have developed similar CNS tumors.

2. "Respiratory disease." The du Pont data indicate an increased risk of lung cancer among employees exposed to acrylonitrile.

3. "Gastrointestinal disease." The du Pont data indicate an increased risk of cancer of the colon among employees exposed to acrylonitrile. In addition, the animal studies show possible tumor production in the stomachs of the rats in the ingestion study.

4. "Skin disease." Acrylonitrile can cause skin burns when prolonged skin contact with the liquid occurs. In addition, repeated skin contact with the liquid can cause dermatitis.

5. "General." The purpose of the medical procedures outlined in the standard is to establish a baseline for future health monitoring. Persons unusually susceptible to the effects of anoxia or those with anemia would be expected to be at increased risk. In addition to emphasis on the CNS, respiratory and gastrointestinal systems, the cardiovascular system, liver, and kidney function should also be stressed.

[58 FR 35655, July 1, 1993]

1915.1045 Appendix D Sampling and analytical methods for acrylonitrile.

There are many methods available for monitoring employee exposures to acrylonitrile. Most of these involve the use of charcoal tubes and sampling pumps, with analysis by gas chromatograph. The essential differences between the charcoal tube methods include, among others, the use of different desorbing solvents, the use of different lots of charcoal, and the use of different equipment for analysis of the samples.

Besides charcoal, considerable work has been performed on methods using porous polymer sampling tubes and passive dosimeters. In addition, there are several portable gas analyzers and monitoring units available on the open market.

This appendix contains details for the methods which have been tested at OSHA Analytical Laboratory in Salt Lake City, and NIOSH in Cincinnati. Each is a variation on NIOSH Method S-156, which is also included for reference. This does not indicate that these methods are the only ones which will be satisfactory. There also may be workplace situations in which these methods are not adequate, due to such factors as high humidity. Copies of the other methods available to OSHA are available in the rulemaking record, and may be obtained from the OSHA Docket Office. These include, the Union Carbide, Monsanto, Dow Chemical and Dow Badische methods, as well as NIOSH Method P & CAM 127.

Employers who note problems with sample breakthrough should try larger charcoal tubes. Tubes of larger capacity are available, and are often used for sampling vinyl chloride. In addition, lower flow rates and shorter sampling times should be beneficial in minimizing breakthrough problems.

Whatever method the employer chooses, he must assure himself of the method's accuracy and precision under the unique conditions present in his workplace.

"NIOSH Method S-156 (Unmodified)"

Analyte: Acrylonitrile. Matrix: Air. Procedure: Absorption on charcoal, desorption with methanol, GC.

1. "Principle of the method" (Reference 11.1).

1.1 A known volume of air is drawn through a charcoal tube to trap the organic vapors present.

1.2 The charcoal in the tube is transferred to a small, stoppered sample container, and the analyte is desorbed with methanol.

1.3 An aliquot of the desorbed sample is injected into a gas chromatograph.

1.4 The area of the resulting peak is determined and compared with areas obtained for standards.

2. "Range and sensitivity."

2.1 This method was validated over the range of 17.5-70.0 mg/cu m at an atmospheric temperature and pressure of 22 deg. C and 760 MM Hg, using a 20-liter sample. Under the conditions of sample size (20-liters) the probable useful range of this method is 4.5-135 mg-cu m. The method is capable of measuring much smaller amounts if the desorption efficiency is adequate. Desorption efficiency must be determined over the range used.

2.2 The upper limit of the range of the method is dependent on the adsorptive capacity of the charcoal tube. This capacity varies with the concentrations of acrylonitrile and other substances in the air. The first section of the charcoal tube was found to hold at least 3.97 mg of acrylonitrile when a test atmosphere containing 92.0 mg/cu m of acrylonitrile in air was sampled 0.18 liter per minute for 240 minutes; at that time the concentration of acrylonitrile in the effluent was less than 5 percent of that in the influent. (The charcoal tube consists of two sections of activated charcoal separated by a section of urethane foam. See section 6.2.) If a particular atmosphere is suspected of containing a large amount of contaminant, a smaller sampling volume should be taken.

3. "Interference."

3.1 When the amount of water in the air is so great that condensation actually occurs in the tube, organic vapors will not be trapped efficiently. Preliminary experiments using toluene indicate that high humidity severely decreases the breakthrough volume.

3.2 When interfering compounds are known or suspected to be present in the air, such information, including their suspected identities, should be transmitted with the sample.

3.3 It must be emphasized that any compound which has the same retention time as the analyte at the operating conditions described in this method is an interference. Retention time data on a single column cannot be considered proof of chemical identity.

3.4 If the possibility of interference exists, separation conditions (column packing, temperature, etc.) must be changed to circumvent the problem.

4. "Precision and accuracy."

4.1 The Coefficient of Variation (CV(T)) for the total analytical and sampling method in the range of 17.5-70.0 mg/cu m was 0.073. This value corresponds to a 3.3 mg/cu m standard deviation at the (previous) OSHA standard level (20 ppm). Statistical information and details of the validation and experimental test procedures can be found in Reference 11.2.

4.2 On the average the concentrations obtained at the 20 ppm level using the overall sampling and analytical method were 6.0 percent lower than the "true" concentrations for a limited number of laboratory experiments. Any difference between the "found" and "true" concentrations may not represent a bias in the sampling and analytical method, but rather a random variation from the experimentally determined "true" concentration. Therefore, no recovery correction should be applied to the final result in section 10.5.

5. "Advantages and disadvantages of the method."

5.1 The sampling device is small, portable, and involves no liquids. Interferences are minimal, and most of those which do occur can be eliminated by altering chromatographic conditions. The tubes are analyzed by means of a quick, instrumental method.

The method can also be used for the simultaneous analysis of two or more substances suspected to be present in the same sample by simply changing gas chromatographic conditions.

5.2 One disadvantage of the method is that the amount of sample which can be taken is limited by the number of milligrams that the tube will hold before overloading. When the sample value obtained for the backup section of the charcoal tube exceeds 25 percent of that found on the front section, the possibility of sample loss exists.

5.3 Furthermore, the precision of the method is limited by the reproducibility of the pressure drop across the tubes. This drop will affect the flow rate and cause the volume to be imprecise, because the pump is usually calibrated for one tube only.

6. "Apparatus."

6.1 A calibrated personal sampling pump whose flow can be determined within + or - 5 percent at the recommended flow rate. (Reference 11.3).

6.2 Charcoal tubes: Glass tubes with both ends flame sealed, 7 cm long with a 6-mm O.D. and a 4-mm I.D., containing 2 sections of 20/40 mesh activated charcoal separated by a 2-mm portion of urethane foam. The activated charcoals prepared from coconut shells and is fired at 600 deg. C prior to packing. The adsorbing section contains 100 mg of charcoal, the backup section 50 mg. A 3-mm portion of urethane foam is placed between the outlet end of the tube and the backup section. A plug of silicated glass wool is placed in front of the adsorbing section. The pressure drop across the tube must be less than 1 inch of mercury at a flow rate of 1 liter per minute.

6.3 Gas chromatograph equipped with a flame ionization detector.

6.4 Column (4-ftX 1/4 -in stainless steel) packed with 50/80 mesh Poropak, type Q.

6.5 An electronic integrator or some other suitable method for measuring peak areas.

6.6 Two-milliliter sample containers with glass stoppers or Teflon-lined caps. If an automatic sample injector is used, the associated vials may be used.

6.7 Microliter syringes: 10-microliter and other convenient sizes for making standards.

6.8 Pipets: 1.0-ml delivery pipets.

6.9 Volumetric flask: 10-ml or convenient sizes for making standard solutions.

7. "Reagents."

7.1 Chromatographic quality methanol.

7.2 Acrylonitrile, reagent grade.

7.3 Hexane, reagent grade.

7.4 Purified nitrogen.

7.5 Prepurified hydrogen.

7.6 Filtered compressed air.

8. "Procedure."

8.1 Cleaning of equipment. All glassware used for the laboratory analysis should be detergent washed and thoroughly rinsed with tap water and distilled water.

8.2 Calibration of personal pumps. Each personal pump must be calibrated with a representative charcoal tube in the line. This will minimize errors associated with uncertainties in the sample volume collected.

8.3 Collection and shipping of samples.

8.3.1 Immediately before sampling, break the ends of the tube to provide an opening at least one-half the internal diameter of the tube (2 mm).

8.3.2 The smaller section of charcoal is used as a backup and should be positioned nearest the sampling pump.

8.3.3 The charcoal tube should be placed in a vertical direction during sampling to minimize channeling through the charcoal.

8.3.4 Air being sampled should not be passed through any hose or tubing before entering the charcoal tube.

8.3.5 A maximum sample size of 20 liters is recommended. Sample at a flow of 0.20 liter per minute or less. The flow rate should be known with an accuracy of at least + or - 5 percent.

8.3.6 The temperature and pressure of the atmosphere being sampled should be recorded. If pressure reading is not available, record the elevation.

8.3.7 The charcoal tubes should be capped with the supplied plastic caps immediately after sampling. Under no circumstances should rubber caps be used.

8.3.8 With each batch of 10 samples submit one tube from the same lot of tubes which was used for sample collection and which is subjected to exactly the same handling as the samples except that no air is drawn through it. Label this as a blank.

8.3.9 Capped tubes should be packed tightly and padded before they are shipped to minimize tube breakage during shipping.

8.3.10 A sample of the bulk material should be submitted to the laboratory in a glass container with a Teflon-lined cap. This sample should not be transported in the same container as the charcoal tubes.

8.4 Analysis of samples.

8.4.1 Preparation of samples. In preparation for analysis, each charcoal tube is scored with a file in front of the first section of charcoal and broken open. The glass wool is removed and discarded. The charcoal in the first (larger) section is transferred to a 2-ml stoppered sample container. The separating section of foam is removed and discarded; the second section is transferred to another stoppered container. These two sections are analyzed separately.

8.4.2 Desorption of samples. Prior to analysis, 1.0 ml of methanol is pipetted into each sample container. Desorption should be done for 30 minutes. Tests indicate that this is adequate if the sample is agitated occasionally during this period. If an automatic sample injector is used, the sample vials should be capped as soon as the solvent is added to minimize volatilization.

8.4.3 GC conditions. The typical operating conditions for the gas chromatograph are:

1. 50 ml/min (60 psig) nitrogen carrier gas flow. 2. 65 ml/min (24 psig) hydrogen gas flow to detector. 3. 500 ml/min (50 psig) air flow to detector. 4. 235 deg. C injector temperature. 5. 255 deg. C manifold temperature (detector). 6. 155 deg. C column temperature.

8.4.4 Injection. The first step in the analysis is the injection of the sample into the gas chromatograph. To eliminate difficulties arising from blowback or distillation within the syringe needle, one should employ the solvent flush injection technique. The 10-microliter syringe is first flushed with solvent several times to wet the barrel and plunger. Three microliters of solvent are drawn into the syringe to increase the accuracy and reproducibility of the injected sample volume. The needle is removed from the solvent, and the plunger is pulled back about 0.2 microliter to separate the solvent flush from the sample with a pocket of air to be used as a marker. The needle is then immersed in the sample, and a 5-microliter aliquot is withdrawn, taking into consideration the volume of the needle, since the sample in the needle will be completely injected. After the needle is removed from the sample and prior to injection, the plunger is pulled back 1.2 microliters to minimize evaporation of the sample from the tip of the needle. Observe that the sample occupies 4.9-5.0 microliters in the barrel of the syringe. Duplicate injections of each sample and standard should be made. No more than a 3 percent difference in area is to be expected. An automatic sample injector can be used if it is shown to give reproducibility at least as good as the solvent flush method.

8.4.5 Measurement of area. The area of the sample peak is measured by an electronic integrator or some other suitable form of area measurement, and preliminary results are read from a standard curve prepared as discussed below.

8.5 Determination of desorption efficiency.

8.5.1 Importance of determination. The desorption efficiency of a particular compound can vary from one laboratory to another and also from one batch of charcoal to another. Thus, it is necessary to determine at least once the percentage of the specific compound that is removed in the desorption process, provided the same batch of charcoal is used.

8.5.2 Procedure for determining desorption efficiency. Activated charcoal equivalent to the amount in the first section of the sampling tube (100 mg) is measured into a 2.5 in, 4-mm I.D. glass tube, flame sealed at one end. This charcoal must be from the same batch as that used in obtaining the samples and can be obtained from unused charcoal tubes. The open end is capped with Parafilm. A known amount of hexane solution of acrylonitrile containing 0.239 g/ml is injected directly into the activated charcoal with a microliter syringe, and tube is capped with more Parafilm. When using an automatic sample injector, the sample injector vials, capped with Teflon-faced septa, may be used in place of the glass tube.

The amount injected is equivalent to that present in a 20-liter air sample at the selected level.

Six tubes at each of three levels (0.5X, 1X, and 2X of the standard) are prepared in this manner and allowed to stand for at least overnight to assure complete adsorption of the analyte onto the charcoal. These tubes are referred to as the sample. A parallel blank tube should be treated in the same manner except that no sample is added to it. The sample and blank tubes are desorbed and analyzed in exactly the same manner as the sampling tube described in section 8.4.

Two or three standards are prepared by injecting the same volume of compound into 1.0 ml of methanol with the same syringe used in the preparation of the samples. These are analyzed with the samples.

The desorption efficiency (D.E.) equals the average weight in mg recovered from the tube divided by the weight in mg added to the tube, or

D.E.

Average weight recovered (mg)
______________________________
weight added (mg)

The desorption efficiency is dependent on the amount of analyte collected on the charcoal. Plot the desorption efficiency versus weight of analyte found. This curve is used in section 10.4 to correct for adsorption losses.

9. "Calibration and standards."

It is convenient to express concentration of standards in terms of mg/1.0 ml methanol, because samples are desorbed in this amount of methanol. The density of the analyte is used to convert mg into microliters for easy measurement with a microliter syringe. A series of standards, varying in concentration over the range of interest, is prepared and analyzed under the same GC conditions and during the same time period as the unknown samples. Curves are established by plotting concentration in mg/1.0 ml versus peak area.

Note: Since no internal standard is used in the method, standard solutions must be analyzed at the same time that the sample analysis is done. This will minimize the effect of known day-to-day variations and variations during the same day of the FID response.

10. "Calculations."

10.1 Read the weight, in mg, corresponding to each peak area from the standard curve. No volume corrections are needed, because the standard curve is based on mg/1.0 ml methanol and the volume of sample injected is identical to the volume of the standards injected.

10.2 Corrections for the bank must be made for each sample.

mg = mg sample-mg blank Where: mg sample = mg found in front section of sample tube. mg sample = mg found in front section of blank tube.

A similar procedure is followed for the backup sections.

10.3 Add the weights found in the front and backup sections to get the total weight in the sample.

10.4 Read the desorption efficiency from the curve (see § 8.5.2) for the amount found in the front section. Divide the total weight by this desorption efficiency to obtain the corrected mg/sample.

Corrected mg/sample

Total weight
_____________
D.E.

10.5 The concentration of the analyte in the air sampled can be expressed in mg/cu m.

mg/cu m

Corrected mg (section
10.4) X

1,000 (liter/cu m)
__________________________
air volume sampled (liter)

10.6 Another method of expressing concentration is ppm.

ppm = m mg/cu X 24.45/M.W. X 760/PX T. + 273/298

Where:
P = Pressure (mm Hg) of air sampled.
T = Temperature (deg. C) of air sampled.
24.45 = Molar volume (liter/mole) at 25 deg. C and 760 mm Hg.
M.W. = Molecular weight (g/mole) of analyte.
760 = Standard pressure (mm Hg).
298 = Standard temperature (deg.K).

11. "References."

11.1 White, L. D. et al., "A Convenient Optimized Method for the Analysis of Selected Solvent Vapors in the Industrial Atmosphere," Amer. Ind. Hyg. Assoc. J., 31:225 (1970).

11.2 Documentation of NIOSH Validation Tests, NIOSH Contract No. CDC-99-74-45.

11.3 Final Report, NIOSH Contract HSM-99-71-31, "Personal Sampler Pump for Charcoal Tubes," September 15, 1972.

NIOSH Modification of NIOSH Method S-156

The NIOSH recommended method for low levels for acrylonitrile is a modification of method S-156. It differs in the following respects:

(1) Samples are desorbed using 1 ml of 1 percent acetone in CS(2) rather than methanol.

(2) The analytical column and conditions are:

Column: 20 percent SP-1000 on 80/100 Supelcoport 10 feet x 1/8 inch

S.S.
Conditions:
Injector temperature: 200 deg. C.
Detector temperature: 100 deg. C.
Column temperature: 85 deg. C.
Helium flow: 25 ml/min.
Air flow: 450 ml/min.
Hydrogen flow: 55 ml/min.

(3) A 2 ul injection of the desorbed analyte is used.

(4) A sampling rate of 100 ml/min is recommended.

OSHA Laboratory Modification of NIOSH Method S-156

Analyte: Acrylonitrile. Matrix: Air. Procedure: Adsorption on charcoal, desorption with methanol, GC.

1. "Principle of the Method" (Reference 1).

1.1 A known volume of air is drawn through a charcoal tube to trap the organic vapors present.

1.2 The charcoal in the tube is transferred to a small, stoppered sample vial, and the analyte is desorbed with methanol.

1.3 An aliquot of the desorbed sample is injected into a gas chromatograph.

1.4 The area of the resulting peak is determined and compared with areas obtained for standards.

2. "Advantages and disadvantages of the method."

2.1 The sampling device is small, portable, and involves no liquids. Interferences are minimal, and most of those which do occur can be eliminated by altering chromatographic conditions. The tubes are analyzed by means of a quick, instrumental method.

2.2 This method may not be adequate for the simultaneous analysis of two or more substances.

2.3 The amount of sample which can be taken is limited by the number of milligrams that the tube will hold before overloading. When the sample value obtained for the backup section of the charcoal tube exceeds 25 percent of that found on the front section, the possibility of sample loss exists.

2.4 The precision of the method is limited by the reproducibility of the pressure drop across the tubes. This drop will affect the flow rate and cause the volume to be imprecise, because the pump is usually calibrated for one tube only.

3. "Apparatus."

3.1 A calibrated personal sampling pump whose flow can be determined within + or - (5) percent at the recommended flow rate.

3.2 Charcoal tubes: Glass tube with both ends flame sealed, 7 cm long with a 6-mm O.D. and a 4-mm I.D., containing 2 sections of 20/40 mesh activated charcoal separated by a 2-mm portion of urethane foam. The activated charcoal is prepared from coconut shells and is fired at 600 deg. C prior to packing. The adsorbing section contains 100 mg of charcoal, the back-up section 50 mg. A 3-mm portion of urethane foam is placed between the outlet end of the tube and the back-up section. A plug of sililated glass wool is placed in front of the adsorbing section. The pressure drop across the tube must be less than one inch of mercury at a flow rate of 1 liter per minute.

3.3 Gas chromatograph equipped with a nitrogen phosphorus detector.

3.4 Column (10-ft x 1/8"-in stainless steel) packed with 100/120 Supelcoport coated with 10 percent SP 1000.

3.5 An electronic integrator or some other suitable method for measuring peak area.

3.6 Two-milliliter sample vials with Teflon-lined caps

3.7 Microliter syringes: 10-microliter, and other convenient sizes for making standards.

3.8 Pipets: 1.0-ml delivery pipets.

3.9 Volumetric flasks: convenient sizes for making standard solutions.

4. "Reagents."

4.1 Chromatographic quality methanol.

4.2 Acrylonitrile, reagent grade.

4.3 Filtered compressed air.

4.4 Purified hydrogen.

4.5 Purified helium.

5. "Procedure."

5.1 Cleaning of equipment. All glassware used for the laboratory analysis should be properly cleaned and free of organics which could interfere in the analysis.

5.2 Calibration of personal pumps. Each pump must be calibrated with a representative charcoal tube in the line.

5.3 Collection and shipping of samples.

5.3.1 Immediately before sampling, break the ends of the tube to provide an opening at least one-half the internal diameter of the tube (2 mm).

5.3.2 The smaller section of the charcoal is used as the backup and should be placed nearest the sampling pump.

5.3.3 The charcoal should be placed in a vertical position during sampling to minimize channeling through the charcoal.

5.3.4 Air being sampled should not be passed through any hose or tubing before entering the charcoal tube.

5.3.5 A sample size of 20 liters is recommended. Sample at a flow rate of approximately 0.2 liters per minute. The flow rate should be known with an accuracy of at least + or - (5) percent.

5.3.6 The temperature and pressure of the atmosphere being sampled should be recorded.

5.3.7 The charcoal tubes should be capped with the supplied plastic caps immediately after sampling. Rubber caps should not be used.

5.3.8 Submit at least one blank tube (a charcoal tube subjected to the same handling procedures, without having any air drawn through it) with each set of samples.

5.3.9. Take necessary shipping and packing precautions to minimize breakage of samples.

5.4 Analysis of samples.

5.4.1 Preparation of samples. In preparation for analysis, each charcoal tube is scored with a file in front of the first section of charcoal and broken open. The glass wool is removed and discarded. The charcoal in the first (larger) section is transferred to a 2-ml vial. The separating section of foam is removed and discarded; the section is transferred to another capped vial. These two sections are analyzed separately.

5.4.2 Desorption of samples. Prior to analysis, 1.0 ml of methanol is pipetted into each sample container. Desorption should be done for 30 minutes in an ultrasonic bath. The sample vials are recapped as soon as the solvent is added.

5.4.3 GC conditions. The typical operating conditions for the gas chromatograph are:

1. 30 ml/min (60 psig) helium carrier gas flow. 2. 3.0 ml/min (30 psig) hydrogen gas flow to detector. 3. 50 ml/min (60 psig) air flow to detector. 4. 200 deg. C injector temperature. 5. 200 deg. C dejector temperature. 6. 100 deg. C column temperature.

5.4.4 Injection. Solvent flush technique or equivalent.

5.4.5 Measurement of area. The area of the sample peak is measured by an electronic integator or some other suitable form of area measurement, and preliminary results are read from a standard curve prepared as discussed below.

5.5 Determination of desorption efficiency.

5.5.1 Importance of determination. The desorption efficiency of a particular compound can vary from one laboratory to another and also from one batch of charcoal to another. Thus, it is necessary to determine, at least once, the percentage of the specific compound that is removed in the desorption process, provided the same batch of charcoal is used.

5.5.2 Procedure for determining desorption efficiency. The reference portion of the charcoal tube is removed. To the remaining portion, amounts representing 0.5X, 1X, and 2X (X represents TLV) based on a 20 l air sample are injected onto several tubes at each level. Dilutions of acrylonitrile with methanol are made to allow injection of measurable quantities. These tubes are then allowed to equilibrate at least overnight. Following equilibration they are analyzed following the same procedure as the samples A curve of the desorption efficiency amt recovered/amt added is plotted versus amount of analyte found. This curve is used to correct for adsorption losses.

6. "Calibration and standards."

A series of standards, varying in concentration over the range of interest, is prepared and analyzed under the same GC conditions and during the same time period as the unknown samples. Curves are prepared by plotting concentration versus peak area.

7. "Calculations."

Read the weight, corresponding to each peak area from the standard curve, correct for the blank, correct for the desorption efficiency, and make necessary air volume corrections.

8. "Reference". NIOSH Method S-156.

[58 FR 35656, July 1, 1993]

1915.1047 Ethylene oxide.

(a) "Scope and application." (1) This section applies to all occupational exposures to ethylene oxide (EtO), Chemical Abstracts Service Registry No. 75-21-8, except as provided in paragraph (a)(2) of this section.

(2) This section does not apply to the processing, use, or handling of products containing EtO where objective data are reasonably relied upon that demonstrate that the product is not capable of releasing EtO in airborne concentrations at or above the action level, and may not reasonably be foreseen to release EtO in excess of the excursion limit, under the expected conditions of processing, use, or handling that will cause the greatest possible release.

(3) Where products containing EtO are exempted under paragraph (a)(2) of this section, the employer shall maintain records of the objective data supporting that exemption and the basis for the employer's reliance on the data, as provided in paragraph (k)(1) of this section.

(b) "Definitions:" For the purpose of this section, the following definitions shall apply:

"Action level" means a concentration of airborne EtO of 0.5 ppm calculated as an eight (8)-hour time-weighted average.

"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.

"Director" means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee.

"Emergency" means any occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment that is likely to or does result in an unexpected significant release of EtO.

"Employee exposure" means exposure to airborne EtO which would occur if the employee were not using respiratory protective equipment.

"Ethylene oxide" or "EtO" means the three-membered ring organic compound with chemical formula C(2)H(4)O.

(c) "Permissible exposure limits" - (1) "8-hour time-weighted average (TWA)." The employer shall ensure that no employee is exposed to an airborne concentration of EtO in excess of one (1) part EtO per million parts of air (1 ppm) as an 8-hour time-weighted average (8-hour TWA).

(2) "Excursion limit." The employer shall ensure that no employee is exposed to an airborne concentration of EtO in excess of 5 parts of EtO per million parts of air (5 ppm) as averaged over a sampling period of fifteen (15) minutes.

(d) "Exposure monitoring" - (1) "General." (i) Determinations of employee exposure shall be made from breathing zone air samples that are representative of the 8-hour TWA and 15-minute short-term exposures of each employee.

(ii) Representative 8-hour TWA employee exposure shall be determined on the basis of one or more samples representing full-shift exposure for each shift for each job classification in each work area. Representative 15-minute short-term employee exposures shall be determined on the basis of one or more samples representing 15-minute exposures associated with operations that are most likely to produce exposures above the excursion limit for each shift for each job classification in each work area.

(iii) Where the employer can document that exposure levels are equivalent for similar operations in different work shifts, the employer need only determine representative employee exposure for that operation during one shift.

(2) "Initial monitoring." (i) Each employer who has a workplace or work operation covered by this standard, except as provided for in paragraph (a)(2) or (d)(2)(ii) of this section, shall perform initial monitoring to determine accurately the airborne concentrations of EtO to which employees may be exposed.

(ii) Where the employer has monitored after June 15, 1983 and the monitoring satisfies all other requirements of this section, the employer may rely on such earlier monitoring results to satisfy the requirements of paragraph (d)(2)(i) of this section.

(iii) Where the employer has previously monitored for the excursion limit and the monitoring satisfies all other requirements of this section, the employer may rely on such earlier monitoring results to satisfy the requirements of paragraph (d)(2)(i) of this section.

(3) "Monitoring frequency (periodic monitoring)." (i) If the monitoring required by paragraph (d)(2) of this section reveals employee exposure at or above the action level but at or below the 8-hour TWA, the employer shall repeat such monitoring for each such employee at least every 6 months.

(ii) If the monitoring required by paragraph (d)(2)(i) of this section reveals employee exposure above the 8-hour TWA, the employer shall repeat such monitoring for each such employee at least every 3 months.

(iii) The employer may alter the monitoring schedule from quarterly to semiannually for any employee for whom two consecutive measurements taken at least 7 days apart indicate that the employee's exposure has decreased to or below the 8-hour TWA.

(iv) If the monitoring required by paragraph (d)(2)(i) of this section reveals employee exposure above the 15 minute excursion limit, the employer shall repeat such monitoring for each such employee at least every 3 months, and more often as necessary to evaluate exposure the employee's short-term exposures.

(4) "Termination of monitoring." (i) If the initial monitoring required by paragraph (d)(2)(i) of this section reveals employee exposure to be below the action level, the employer may discontinue TWA monitoring for those employees whose exposures are represented by the initial monitoring.

(ii) If the periodic monitoring required by paragraph (d)(3) of this section reveals that employee exposures, as indicated by at least two consecutive measurements taken at least 7 days apart, are below the action level, the employer may discontinue TWA monitoring for those employees whose exposures are represented by such monitoring.

(iii) If the initial monitoring required by paragraph (d)(2)(i) of this section reveals employee exposure to be at or below the excursion limit, the employer may discontinue excursion limit monitoring for those employees whose exposures are represented by the initial monitoring.

(iv) If the periodic monitoring required by paragraph (d)(3) of this section reveals that employee exposures, as indicated by at least two consecutive measurements taken at least 7 days apart, are at or below the excursion limit, the employer may discontinue excursion limit monitoring for those employees whose exposures are represented by such monitoring.

(5) "Additional monitoring." Notwithstanding the provisions of paragraph (d)(4) of this section, the employer shall institute the exposure monitoring required under paragraphs (d)(2)(i) and (d)(3) of this section whenever there has been a change in the production, process, control equipment, personnel or work practices that may result in new or additional exposures to EtO or when the employer has any reason to suspect that a change may result in new or additional exposures.

(6) "Accuracy of monitoring." (i) Monitoring shall be accurate, to a confidence level of 95 percent, to within plus or minus 25 percent for airborne concentrations of EtO at the 1 ppm TWA and to within plus or minus 35 percent for airborne concentrations of EtO at the action level of 0.5 ppm.

(ii) Monitoring shall be accurate, to a confidence level of 95 percent, to within plus or minus 35 percent for airborne concentrations of EtO at the excursion limit.

(7) "Employee notification of monitoring results." (i) The employer shall, within 15 working days after the receipt of the results of any monitoring performed under this standard, notify the affected employee of these results in writing either individually or by posting of results in an appropriate location that is accessible to affected employees.

(e) "Regulated Areas." (1) The employer shall establish a regulated area wherever occupational exposures to airborne concentrations of EtO may exceed the TWA or wherever the EtO concentration exceeds or can reasonably be expected to exceed the excursion limit.

(2) Access to regulated areas shall be limited to authorized persons.

(3) Regulated areas shall be demarcated in any manner that minimizes the number of employees within the regulated area.

(f) "Methods of compliance." - (1) "Engineering controls and work practices." (i) The employer shall institute engineering controls and work practices to reduce and maintain employee exposure to or below the TWA and to or below the excursion limit, except to the extent that such controls are not feasible.

(ii) Wherever the feasible engineering controls and work practices that can be instituted are not sufficient to reduce employee exposure to or below the TWA and to or below the excursion limit, the employer shall use them to reduce employee exposure to the lowest levels achievable by these controls and shall supplement them by the use of respiratory protection that complies with the requirements of paragraph (g) of this section.

(iii) Engineering controls are generally infeasible for the following operations: collection of quality assurance sampling from sterilized materials removal of biological indicators from sterilized materials: loading and unloading of tank cars; changing of ethylene oxide tanks on sterilizers; and vessel cleaning. For these operations, engineering controls are required only where the Assistant Secretary demonstrates that such controls are feasible.

(2) "Compliance program." (i) Where the TWA or excursion limit is exceeded, the employer shall establish and implement a written program to reduce exposure to or below the TWA and to or below the excursion limit by means of engineering and work practice controls, as required by paragraph (f)(1) of this section, and by the use of respiratory protection where required or permitted under this section.

(ii) The compliance program shall include a schedule for periodic leak detection surveys and a written plan for emergency situations, as specified in paragraph (h)(i) of this section.

(iii) Written plans for a program required in paragraph (f)(2) shall be developed and furnished upon request for examination and copying to the Assistant Secretary, the Director, affected employees and designated employee representatives. Such plans shall be reviewed at least every 12 months, and shall be updated as necessary to reflect significant changes in the status of the employer's compliance program.

(iv) The employer shall not implement a schedule of employee rotation as a means of compliance with the TWA or excursion limit.

(g) "Respiratory protection and personal protective equipment" - (1) "General." The employer shall provide respirators, and ensure that they are used, where required by this section. Respirators shall be used in the following circumstances.

(i) During the interval necessary to install or implement feasible engineering and work practice controls;

(ii) In work operations, such as maintenance and repair activities, vessel cleaning, or other activities for which engineering and work practice controls are not feasible;

(iii) In work situations where feasible engineering and work practice controls are not yet sufficient to reduce exposure to or below the TWA or excursion limit; and

(iv) In emergencies.

(2) "Respirator selection." (i) Where respirators are required under this section, the employer shall select and provide, at no cost to the employee, the appropriate respirator as specified in Table 1, and shall ensure that the employee uses the respirator provided.

(ii) The employer shall select respirators from among those jointly approved as being acceptable for protection against EtO by the Mine Safety and Health Administration (MSHA) and by the National Institute for Occupational Safety and Health (NIOSH) under the provisions of 30 CFR Part 11.

(3) "Respirator program." Where respiratory protection is required by this section, the employer shall institute a respirator program in accordance with 29 CFR 1910.134(b), (d), (e), and (f).

(4) "Protective clothing and equipment." Where eye or skin contact with liquid EtO or EtO solutions may occur, the employer shall select and provide, at no cost to the employee, appropriate protective clothing or other equipment in accordance with 29 CFR 1910.132 and 1910.133 to protect any area of the body that may come in contact with liquid EtO or EtO in solution, and shall ensure that the employee wears the protective clothing and equipment provided.

(h) "Emergency situations." - (1) "Written plan." (i) A written plan for emergency situations shall be developed for each workplace where there is a possibility of an emergency. Appropriate portions of the plan shall be implemented in the event of an emergency.

(ii) The plan shall specifically provide that employees engaged in correcting emergency conditions shall be equipped with respiratory protection as required by paragraph (g) of this section until the emergency is abated.

(iii) The plan shall include the elements prescribed in 29 CFR 1910.38, "Employee emergency plans and fire prevention plans."

(2) "Alerting employees." Where there is the possibility of employee exposure to EtO due to an emergency, means shall be developed to alert potentially affected employees of such occurrences promptly. Affected employees shall be immediately evacuated from the area in the event that an emergency occurs.

TABLE 1 - MINIMUM REQUIREMENTS FOR RESPIRATORY PROTECTION FOR AIRBORNE EtO
Condition of use or concentration of airborne EtO (ppm)	Minimum required respirator
Equal to or less than 50	(a) Full facepiece respirator with EtO approved canister, front-or back-mounted.
Equal to or less than 2,000	(a) Positive-pressure supplied air respirator, equipped with full facepiece, hood, or helmet, or (b) Continuous-flow supplied air respirator (positive pressure) equipped with hood, helmet or suit.
Concentration above 2,000 or unknown concentration (such as in emergencies)	(a) Positive-pressure self-contained breathing apparatus (SCBA), equipped with full facepiece, or (b) Positive-pressure full facepiece supplied air respirator equipped with an auxiliary positive-pressure self-contained breathing apparatus.
Firefighting	(a) Positive pressure self-contained breathing apparatus equipped with full facepiece.
Escape	(a) Any respirator described above.

Note. - Respirators approved for use in higher concentrations are permitted to be used in lower concentrations.

(i) "Medical Surveillance" - (1) "General" - (i) "Employees covered."

(A) The employer shall institute a medical surveillance program for all employees who are or may be exposed to EtO at or above the action level, without regard to the use of respirators, for at least 30 days a year.

(B) The employer shall make available medical examinations and consultations to all employees who have been exposed to EtO in an emergency situation.

(ii) "Examination by a physician." The employer shall ensure that all medical examinations and procedures are performed by or under the supervision of a licensed physician, and are provided without cost to the employee, without loss of pay, and at a reasonable time and place.

(2) "Medical examinations and consultations." (i) Frequency. The employer shall make available medical examinations and consultations to each employee covered under paragraph (i)(1)(i) of this section on the following schedules:

(A) Prior to assignment of the employee to an area where exposure may be at or above the action level for at least 30 days a year.

(B) At least annually each employee exposed at or above the action level for at least 30 days in the past year.

(C) At termination of employment or reassignment to an area where exposure to EtO is not at or above the action level for at least 30 days a year.

(D) As medically appropriate for any employee exposed during an emergency.

(E) As soon as possible, upon notification by an employee either (1) that the employee has developed signs or symptoms indicating possible overexposure to EtO, or (2) that the employee desires medical advice concerning the effects of current or past exposure to EtO on the employee's ability to produce a healthy child.

(F) If the examining physician determines that any of the examinations should be provided more frequently than specified, the employer shall provide such examinations to affected employees at the frequencies recommended by the physician.

(ii) "Content." (A) Medical examinations made available pursuant to paragraphs (i)(2)(i)(A)-(D) of this section shall include:

(1) A medical and work history with special emphasis directed to symptoms related to the pulmonary, hematologic, neurologic, and reproductive systems and to the eyes and skin.

(2) A physical examination with particular emphasis given to the pulmonary, hematologic, neurologic, and reproductive systems and to the eyes and skin.

(3) A complete blood count to include at least a white cell count (including differential cell count), red cell count, hematocrit, and hemoglobin.

(4) Any laboratory or other test which the examining physician deems necessary by sound medical practice.

(B) The content of medical examinations or consultation made available pursuant to paragraph (i)(2)(i)(E) of this section shall be determined by the examining physician, and shall include pregnancy testing or laboratory evaluation of fertility, if requested by the employee and deemed appropriate by the physician.

(3) "Information provided to the physician." The employer shall provide the following information to the examining physician:

(i) A copy of this standard and Appendices A, B, and C.

(ii) A description of the affected employee's duties as they relate to the employee's exposure.

(iii) The employee's representative exposure level or anticipated exposure level.

(iv) A description of any personal protective and respiratory equipment used or to be used.

(v) Information from previous medical examinations of the affected employee that is not otherwise available to the examining physician.

(4) "Physician's written opinion." (i) The employer shall obtain a written opinion from the examining physician. This written opinion shall contain the results of the medical examination and shall include:

(A) The physician's opinion as to whether the employee has any detected medical conditions that would place the employee at an increased risk of material health impairment from exposure to EtO;

(B) Any recommended limitations on the employee or upon the use of personal protective equipment such as clothing or respirators; and

(C) A statement that the employee has been informed by the physician of the results of the medical examination and of any medical conditions resulting from EtO exposure that require further explanation or treatment.

(ii) The employer shall instruct the physician not to reveal in the written opinion given to the employer specific findings or diagnoses unrelated to occupational exposure to EtO.

(iii) The employer shall provide a copy of the physician's written opinion to the affected employee within 15 days from its receipt.

(j) "Communication of EtO hazards to employees" - (1) "Signs and labels." (i) The employer shall post and maintain legible signs demarcating regulated areas and entrances or accessways to regulated areas that bear the following legend:

DANGER
ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED
TO BE WORN IN THIS AREA

(ii) The employer shall ensure that precautionary labels are affixed to all containers of EtO whose contents are capable of causing employee exposure at or above the action level or whose contents may reasonably be foreseen to cause employee exposure above the excursion limit, and that the labels remain affixed when the containers of EtO leave the workplace. For the purposes of this paragraph, reaction vessels, storage tanks, and pipes or piping systems are not considered to be containers. The labels shall comply with the requirements of 29 CFR 1915.1200(f) of OSHA's Hazard Communication standard, and shall include the following legend:

(A)

DANGER
ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE HAZARD

and (B) A warning statement against breathing airborne concentrations of EtO.

(iii) The labeling requirements under this section do not apply where EtO is used as a pesticide, as such term is defined in the Federal Insecticide. Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), when it is labeled pursuant to that Act and regulations issued under that Act by the Environmental Protection Agency.

(2) "Material safety data sheets." Employers who are manufacturers or importers of EtO shall comply with the requirements regarding development of material safety data sheets as specified in 29 CFR 1915.1200(g) of OSHA's Hazard Communication standard.

(3) "Information and training." (i) The employer shall provide employees who are potentially exposed to EtO at or above the action level or above the excursion limit with information and training on EtO at the time of initial assignment and at least annually thereafter.

(ii) Employees shall be informed of the following:

(A) The requirements of this section with an explanation of its contents, including Appendices A and B;

(B) Any operations in their work area where EtO is present;

(D) The medical surveillance program required by paragraph (i) of this section with an explanation of the information in Appendix C.

(iii) Employee training shall include at least:

(A) Methods and observations that may be used to detect the presence or release of EtO in the work area (such as monitoring conducted by the employer, continuous monitoring devices, etc.);

(B) The physical and health hazards of EtO;

(C) The measures employees can take to protect themselves from hazards associated with EtO exposure, including specific procedures the employer has implemented to protect employees from exposure to EtO, such as work practices, emergency procedures, and personal protective equipment to be used; and

(D) The details of the hazard communication program developed by the employer, including an explanation of the labeling system and how employees can obtain and use the appropriate hazard information.

(k) "Recordkeeping" - (1) "Objective data for exempted operations." (i) Where the processing, use, or handling of products made from or containing EtO are exempted from other requirements of this section under paragraph (a)(2) of this section, or where objective data have been relied on in lieu of initial monitoring under paragraph (d)(2)(ii) of this section, the employer shall establish and maintain an accurate record of objective data reasonably relied upon in support of the exemption.

(ii) This record shall include at least the following information:

(A) The product qualifying for exemption;

(B) The source of the objective data;

(D) A description of the operation exempted and how the data support the exemption; and

(E) Other data relevant to the operations, materials, processing, or employee exposures covered by the exemption.

(iii) The employer shall maintain this record for the duration of the employer's reliance upon such objective data.

(2) "Exposure measurements." (i) The employer shall keep an accurate record of all measurements taken to monitor employee exposure to EtO as prescribed in paragraph (d) of this section.

(ii) This record shall include at least the following information:

(A) The date of measurement;

(B) The operation involving exposure to EtO which is being monitored;

(D) Number, duration, and results of samples taken;

(E) Type of protective devices worn, if any; and

(F) Name, social security number and exposure of the employees whose exposures are represented.

(iii) The employer shall maintain this record for at least thirty (30) years, in accordance with 29 CFR 1915.1120.

(3) "Medical surveillance." (i) The employer shall establish and maintain an accurate record for each employee subject to medical surveillance by paragraph (i)(1)(i) of this section, in accordance with 29 CFR 1915.1120.

(ii) The record shall include at least the following information:

(A) The name and social security number of the employee;

(B) Physicians' written opinions;

(D) A copy of the information provided to the physician as required by paragraph (i)(3) of this section.

(iii) The employer shall ensure that this record is maintained for the duration of employment plus thirty (30) years, in accordance with 29 CFR 1915.1120.

(4) "Availability." (i) The employer, upon written request, shall make all records required to be maintained by this section available to the Assistant Secretary and the Director for examination and copying.

(ii) The employer, upon request, shall make any exemption and exposure records required by paragraphs (k)(1) and (2) of this section available for examination and copying to affected employees, former employees, designated representatives and the Assistant Secretary, in accordance with 29 CFR 1915.1120(a) through (e) and (g) through (i).

(iii) The employer, upon request, shall make employee medical records required by paragraph (k)(3) of this section available for examination and copying to the subject employee, anyone having the specific written consent of the subject employee, and the Assistant Secretary, in accordance with 29 CFR 1915.1120.

(5) "Transfer of records." (i) The employer shall comply with the requirements concerning transfer of records set forth in 29 CFR 1915.1120(h).

(l) "Observation of monitoring" - (1) "Employee observation." The employer shall provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to EtO conducted in accordance with paragraph (d) of this section.

(2) "Observation procedures." When observation of the monitoring of employee exposure to EtO requires entry into an area where the use of protective clothing or equipment is required, the observer shall be provided with and be required to use such clothing and equipment and shall comply with all other applicable safety and health procedures.

(m) "Dates" - (1) - (i) "Effective date." The paragraphs contained in this section shall become effective August 21, 1984, except for paragraphs (a)(2), (d), (e), (f)(2), (g)(3), (h), (i), and (j) which shall become effective on March 12, 1985.

(ii) The requirements in this section which pertain only to or are triggered by the excursion limit shall become effective June 6, 1988, except for the excursion limit provisions in paragraphs (a)(2), (d), (f)(2), (g)(3) and (j) of this section which shall become effective August 25, 1988.

(2) "Start-up dates." (i) The start-up date for the requirements in those paragraphs that were effective on August 21, 1984, including institution of work practice controls specified in paragraph (f)(1), shall be February 19, 1985, except as provided for in paragraph (m)(2)(ii), and the start-up date for paragraphs (a)(2), (d), (e), (f)(2), (g)(3), (h), (i), and (j) of this section shall be September 9, 1985.

(ii) Engineering controls specified by paragraph (f)(1) of this section shall be implemented by August 21, 1985.

(iii) Compliance with the requirements in this section which pertain to or are triggered by the excursion limit shall be by September 6, 1988, except for compliance with the excursion limit provisions of paragraphs (a)(2), (d), (f)(2), (g)(3) and (j) of this section, which shall be by October 6, 1988, and implementation of engineering controls specified for compliance with the excursion limit, which shall be by December 6, 1988.

(3) "Labeling." (i) Paragraph (j)(1)(ii)(A) of this section as amended is effective January 9, 1986.

(ii) Paragraph (j)(1)(iii) of this is effective October 11, 1985. (n) "Appendices." The information contained in the appendices is not intended by itself to create any additional obligations not otherwise imposed or to detract from any existing obligation.

(Approved by the Office of Management and Budget under control number 1218-0108)

[58 FR 35659, July 1, 1993]

1915.1047

Appendix A Substance safety data sheet for ethylene oxide (non-mandatory).

I. "Substance Identification"

A. Substance: Ethylene oxide (C(2)H(4)O).

B. Synonyms: dihydrooxirene, dimethylene oxide, EO, 1,2-epoxyethane, EtO, ETO, oxacyclopropane, oxane, oxidoethane, alpha/beta-oxidoethane, oxiran, oxirane.

C. Ethylene oxide can be found as a liquid or vapor.

D. EtO is used in the manufacture of ethylene glycol, surfactants, ethanolamines, glycol ethers, and other organic chemicals. EtO is also used as a sterilant and fumigant.

E. Appearance and odor: Colorless liquid below 10.7 deg. C (51.3 deg. F) or colorless gas with ether-like odor detected at approximately 700 parts EtO per million parts of air (700 ppm).

F. Permissible Exposure: Exposure may not exceed 1 part EtO per million parts of air averaged over the 8-hour workday.

II. "Health Hazard Data"

A. Ethylene oxide can cause bodily harm if you inhale the vapor, if it comes into contact with your eyes or skin, or if you swallow it.

B. Effects of overexposure:

1. Ethylene oxide in liquid form can cause eye irritation and injury to the cornea, frostbite, and severe irritation and blistering of the skin upon prolonged or confined contact. Ingestion of EtO can cause gastric irritation and liver injury. Acute effects from inhalation of EtO vapors include respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, shortness of breath, and cyanosis (blue or purple coloring of skin). Exposure has also been associated with the occurrence of cancer, reproductive effects, mutagenic changes, neurotoxicity, and sensitization.

1. EtO has been shown to cause cancer in laboratory animals and has been associated with higher incidences of cancer in humans. Adverse reproductive effects and chromosome damage may also occur from EtO exposure.

a. Reporting signs and symptoms: You should inform your employer if you develop any signs or symptoms and suspect that they are caused by exposure to EtO.

III. "Emergency First Aid Procedures"

A. Eye exposure: If EtO gets into your eyes, wash your eyes immediately with large amounts of water, lifting the lower and upper eyelids. Get medical attention immediately. Contact lenses should not be worn when working with this chemical.

B. Skin exposure: If EtO gets on your skin, immediately wash the contaminated skin with water. If EtO soaks through your clothing, especially your shoes, remove the clothing immediately and wash the skin with water using an emergency deluge shower. Get medical attention immediately. Thoroughly wash contaminated clothing before reusing. Contaminated leather shoes or other leather articles should not be reused and should be discarded.

C. Inhalation: If large amounts of EtO are inhaled, the exposed person must be moved to fresh air at once. If breathing has stopped, perform cardiopulmonary resuscitation. Keep the affected person warm and at rest. Get medical attention immediately.

D. Swallowing: When EtO has been swallowed, give the person large quantities of water immediately. After the water has been swallowed, try to get the person to vomit by having him or her touch the back of the throat with his or her finger. Do not make an unconscious person vomit. Get medical attention immediately.

E. Rescue: Move the affected person from the hazardous exposure. If the exposed person has been overcome, attempt rescue only after notifying at least one other person of the emergency and putting into effect established emergency procedures. Do not become a casualty yourself. Understand your emergency rescue procedures and know the location of the emergency equipment before the need arises.

IV. "Respirators and Protective Clothing"

A. Respirators: You may be required to wear a respirator for nonroutine activities, in emergencies, while your employer is in the process of reducing EtO exposures through engineering controls, and where engineering controls are not feasible. As of the effective date of the standard, only air supplied positive-pressure, full-facepiece respirators are approved for protection against EtO. If air-purifying respirators are worn in the future, they must have a joint Mine Safety and Health Administration (MSHA) and National Institute for Occupational Safety and Health (NIOSH) label of approval for use with ethylene oxide. For effective protection, respirators must fit your face and head snugly. Respirators should not be loosened or removed in work situations where their use is required.

EtO does not have a detectable odor except at levels well above the permissible exposure limits. If you can smell EtO while wearing a respirator, proceed immediately to fresh air. If you experience difficulty breathing while wearing a respirator, tell your employer.

B. Protective clothing: You may be required to wear impermeable clothing, gloves, a face shield, or other appropriate protective clothing to prevent skin contact with liquid EtO or EtO-containing solutions. Where protective clothing is required, your employer must provide clean garments to you as necessary to assure that the clothing protects you adequately.

Replace or repair protective clothing that has become torn or otherwise damaged.

EtO must never be allowed to remain on the skin. Clothing and shoes which are not impermeable to EtO should not be allowed to become contaminated with EtO, and if they do, the clothing should be promptly removed and decontaminated. Contaminated leather shoes should be discarded. Once EtO penetrates shoes or other leather articles, they should not be worn again.

C. Eye protection: You must wear splashproof safety goggles in areas where liquid EtO or EtO-containing solutions may contact your eyes. In addition, contact lenses should not be worn in areas where eye contact with EtO can occur.

V. "Precautions for Safe Use, Handling, and Storage"

A. EtO is a flammable liquid, and its vapors can easily form explosive mixtures in air.

B. EtO must be stored in tightly closed containers in a cool, well-ventilated area, away from heat, sparks, flames, strong oxidizers, alkalines, and acids, strong bases, acetylide-forming metals such as cooper, silver, mercury and their alloys.

C. Sources of ignition such as smoking material, open flames and some electrical devices are prohibited wherever EtO is handled, used, or stored in a manner that could create a potential fire or explosion hazard.

D. You should use non-sparking tools when opening or closing metal containers of EtO, and containers must be bonded and grounded in the rare instances in which liquid EtO is poured or transferred.

E. Impermeable clothing wet with liquid EtO or EtO-containing solutions may be easily ignited. If your are wearing impermeable clothing and are splashed with liquid EtO or EtO-containing solution, you should immediately remove the clothing while under an emergency deluge shower.

F. If your skin comes into contact with liquid EtO or EtO-containing solutions, you should immediately remove the EtO using an emergency deluge shower.

G. You should not keep food, beverages, or smoking materials in regulated areas where employee exposures are above the permissible exposure limits.

H. Fire extinguishers and emergency deluge showers for quick drenching should be readily available, and you should know where they are and how to operate them.

I. Ask your supervisor where EtO is used in your work area and for any additional plant safety and health rules.

VI. "Access to Information"

A. Each year, your employer is required to inform you of the information contained in this standard and appendices for EtO. In addition, your employer must instruct you in the proper work practices for using EtO emergency procedures, and the correct use of protective equipment.

B. Your employer is required to determine whether you are being exposed to EtO. You or your representative has the right to observe employee measurements and to record the results obtained. Your employer is required to inform you of your exposure. If your employer determine that you are being overexposed, he or she is required to inform you of the actions which are being taken to reduce your exposure to within permissible exposure limits.

C. Your employer is required to keep records of your exposures and medical examinations. These exposure records must be kept by the employer for at least thirty (30) years. Medical records must be kept for the period of your employment plus thirty (30) years.

D. Your employer is required to release your exposure and medical records to your physician or designated representative upon your written request.

VII. "Sterilant use of ETO in Hospitals and Health Care Facilities"

This section of Appendix A, for informational purposes, sets forth EPA's recommendations for modifications in workplace design and practice in hospitals and health care facilities for which the Environmental Protection Agency has registered EtO for uses as a sterilant or fumigant under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 "et seq". These new recommendations, published in the "Federal Register" by EPA at 49 FR 15268, as modified in today's "Register", are intended to help reduce the exposure of hospital and health care workers to EtO to 1 ppm. EPA's recommended workplace design and workplace practice are as follows:

1. "Workplace Design"

a. "Installation of gas line hand valves." Hand valves must be installed on the gas supply line at the connection to the supply cylinders to minimize leakage during cylinder change.

b. "Installation of capture boxes." Sterilizer operations result in a gas/water discharge at the completion of the process. This discharge is routinely piped to a floor drain which is generally located in an equipment or an adjacent room. When the floor drain is not in the same room as the sterilizer and workers are not normally present, all that is necessary is that the room be well ventilated.

The installation of a "capture box" will be required for those work place layouts where the floor drain is located in the same room as the sterilizer or in a room where workers are normally present. A "capture box" is a piece of equipment that totally encloses the floor drain where the discharge from the sterilizer is pumped. The "capture box" is to be vented directly to a non-recirculating or dedicated ventilation system. Sufficient air intake should be allowed at the bottom of the box to handle the volume of air that is ventilated from the top of the box. The "capture box" can be made of metal, plastic, wood or other equivalent material. The box is intended to reduce levels of EtO discharged into the work room atmosphere. The use of a "capture box" is not required if: (1) The vacuum pump discharge floor drain is located in a well ventilated equipment or other room where workers are not normally present or (2) the water sealed vacuum pump discharges directly to a closed sealed sewer line (check local plumbing codes).

If it is impractical to install a vented "capture box" and a well ventilated equipment or other room is not feasible, a box that can be sealed over the floor drain may be used if: (1) The floor drain is located in a room where workers are not normally present and EtO cannot leak into an occupied area, and (2) the sterilizer in use is less than 12 cubic feet in capacity (check local plumbing codes).

c. "Ventilation of aeration units" i. "Existing aeration units."

Existing units must be vented to a non-recirculating or dedicated system or vented to an equipment or other room where workers are not normally present and which is well ventilated. Aerator units must be positioned as close as possible to the sterilizer to minimize the exposure from the off-gassing of sterilized items.

ii. "Installation of new aerator units (where none exist)." New aerator units must be vented as described above for existing aerators. Aerators must be in place by July 1, 1986.

d. "Ventilation during cylinder change." Workers may be exposed to short but relatively high levels of EtO during the change of gas cylinders. To reduce exposure from this route, users must select one of three alternatives designed to draw off gas that may be released when the line from the sterilizer to the cylinder is disconnected:

i. Location of cylinders in a well ventilated equipment room or other room where workers are not normally present.

ii. Installation of a flexible hose (at least 4" in diameter) to a non-recirculating or dedicated ventilation system and located in the area of cylinder change in such a way that the hose can be positioned at the point where the sterilizer gas line is disconnected from the cylinder.

iii. Installation of a hood that is part of a non-recirculating or dedicated system and positioned no more than one foot above the point where the change of cylinders takes place.

e. "Ventilation of sterilizer door area." One of the major sources of exposure to EtO occurs when the sterilizer door is opened following the completion of the sterilization process. In order to reduce this avenue of exposure, a hood or metal canopy closed on each end must be installed over the sterilizer door. The hood or metal canopy must be connected to a non-recirculating or dedicated ventilation system or one that exhausts gases to a well ventilated equipment or other room where workers are not normally present. A hood or canopy over the sterilizer door is required for use even with those sterilizers that have a purge cycle and must be in place by July 1, 1986.

f. "Ventilation of sterilizer relief valve." Sterilizers are typically equipped with a safety relief device to release gas in case of increased pressure in the sterilizer. Generally, such relief devices are used on pressure vessels. Although these pressure relief devices are rarely opened for hospital and health care sterilizers, it is suggested that they be designed to exhaust vapor from the sterilizer by one of the following methods:

i. Through a pipe connected to the outlet of the relief valve ventilated directly outdoors at a point high enough to be away from passers by, and not near any windows that open, or near any air conditioning or ventilation air intakes.

ii. Through a connection to an existing or new non-recirculating or dedicated ventilation system.

iii. Through a connection to a well ventilated equipment or other room where workers are not normally present.

g. "Ventilation systems." Each hospital and health care facility affected by this notice that uses EtO for the sterilization of equipment and supplies must have a ventilation system which enables compliance with the requirements of section (b) through (f) in the manner described in these sections and within the timeframes allowed. Thus, each affected hospital and health care facility must have or install a non-recirculating or dedicated ventilation equipment or other room where workers are not normally present in which to vent EtO.

h. "Installation of alarm systems." An audible and visual indicator alarm system must be installed to alert personnel of ventilation system failures,i.e., when the ventilation fan motor is not working.

2. "Workplace Practices" ** All the workplace practices discussed in this unit must be permanently posted near the door of each sterilizer prior to use by any operator.

a. "Changing of supply line filters." Filters in the sterilizer liquid line must be changed when necessary, by the following procedure:

i. Close the cylinder valve and the hose valve.

ii. Disconnect the cylinder hose (piping) from the cylinder.

iii. Open the hose valve and bleed slowly into a proper ventilating system at or near the in-use supply cylinders.

iv. Vacate the area until the line is empty.

v. Change the filter.

vi. Reconnect the lines and reverse the value position.

vii. Check hoses, filters, and valves for leaks with a fluorocarbon leak detector (for those sterilizers using the 88 percent chlorofluorocarbon, 12 percent ethylene oxide mixture (12/88)).

b. "Restricted access area." i. Areas involving use of EtO must be designated as restricted access areas. They must be identified with signs or floor marks near the sterilizer door, aerator, vacuum pump floor drain discharge, and in-use cylinder storage.

ii. All personnel must be excluded from the restricted area when certain operations are in progress, such as discharging a vacuum pump, emptying a sterilizer liquid line, or venting a non-purge sterilizer with the door ajar or other operations where EtO might be released directly into the face of workers.

c. "Door opening procedures." i. "Sterilizers with purge cycles." A load treated in a sterilizer equipped with a purge cycle should be removed immediately upon completion of the cycle (provided no time is lost opening the door after cycle is completed). If this is not done, the purge cycle should be repeated before opening door.

ii. "Sterilizers without purge cycles." For a load treated in a sterilizer not equipped with a purge cycle, the sterilizer door must be ajar 6" for 15 minutes, and then fully opened for at least another 15 minutes before removing the treated load. The length of time of the second period should be established by peak monitoring for one hour after the two 15-minute periods suggested. If the level is above 10 ppm time-weighted average for 8 hours, more time should be added to the second waiting period (door wide open). However, in no case may the second period be shortened to less than 15 minutes.

d. "Chamber unloading procedures." i. Procedures for unloading the chamber must include the use of baskets or rolling carts, or baskets and rolling tables to transfer treated loads quickly, thus avoiding excessive contact with treated articles, and reducing the duration of exposures.

ii. If rolling carts are used, they should be pulled not pushed by the sterilizer operators to avoid offgassing exposure.

e. "Maintenance." A written log should be instituted and maintained documenting the date of each leak detection and any maintenance procedures undertaken. This is a suggested use practice and is not required.

i. "Leak detection." Sterilizer door gaskets, cylinder and vacuum piping, hoses, filters, and valves must be checked for leaks under full pressure with a Fluorocarbon leak detector (for 12/88 systems only) every two weeks by maintenance personnel. Also, the cylinder piping connections must be checked after changing cylinders. Particular attention in leak detection should be given to the automatic solenoid valves that control the flow of EtO to the sterilizer. Specifically, a check should be made at the EtO gasline entrance port to the sterilizer, while the sterilizer door is open and the solenoid valves are in a closed position.

ii. "Maintenance procedures." Sterilizer/areator door gaskets, valves, and fittings must be replaced when necessary as determined by maintenance personnel in their bi-weekly checks; in addition, visual inspection of the door gaskets for cracks, debris, and other foreign substances should be conducted daily by the operator.

[58 FR 35663, July 1, 1993]

1915.1047 Appendix B

Substance technical guidelines for ethylene oxide (Non-mandatory).

I. "Physical and Chemical Data"

A. Substance identification:

1. Synonyms: dihydrooxirene, dimethylene oxide, EO, 1,2-epoxyethane, EtO ETO oxacyclopropane, oxane, oxidoethane, alpha/beta-oxidoethane, oxiran, oxirane. 2. Formula: (C(2)H(4)O). 3. Molecular weight: 44.06

B. Physical data: 1. Boiling point (760 mm Hg): 10.70 deg. C (51.3 deg. F); 2. Specific gravity (water = 1): 0.87 (at 20 deg. C or 68 deg. F) 3. Vapor density (air = 1): 1.49; 4. Vapor pressure (at 20 deg. C); 1,095 mm Hg; 5. Solubility in water: complete; 6. Appearance and odor: colorless liquid; gas at temperature above 10.7 deg. F or 51.3 deg. C with ether-like odor above 700 ppm.

II. "Fire, Explosion, and Reactivity Hazard Data"

A. Fire:

1. Flash point: less than O deg. F (open cup);

2. Stability: decomposes violently at temperatures above 800 deg. F;

3. Flammable limits in air, percent by volume: Lower: 3, Upper: 100;

4. Extinguishing media: Carbon dioxide for small fires, polymer or alcohol foams for large fires;

5. Special fire fighting procedures: Dilution of ethylene oxide with 23 volumes of water renders it non-flammable;

6. Unusual fire and explosion hazards: Vapors of EtO will burn without the presence of air or other oxidizers. EtO vapors are heavier than air and may travel along the ground and be ignited by open flames or sparks at locations remote from the site at which EtO is being used.

7. For purposes of compliance with the requirements of 29 CFR 1910.106, EtO is classified as a flammable gas. For example, 7,500 ppm, approximately one-fourth of the lower flammable limit, would be considered to pose a potential fire and explosion hazard.

8. For purposes of compliance with 29 CFR 1910.155, EtO is classified as a Class B fire hazard.

9. For purpose of compliance with 29 CFR 1919.307, locations classified as hazardous due to the presence of EtO shall be Class I.

B. Reactivity:

1. Conditions contributing to instability: EtO will polymerize violently if contaminated with aqueous alkalis, amines, mineral acids, metal chlorides, or metal oxides. Violent decomposition will also occur at temperatures above 800 deg. F;

2. Incompatabilities: Alkalines and acids;

3. Hazardous decomposition products: Carbon monoxide and carbon dioxide.

III. "Spill, Leak, and Disposal Procedures" A. If EtO is spilled or leaked, the following steps should be taken:

1. Remove all ignition sources. 2. The area should be evacuated at once and re-entered only after the area has been thoroughly ventilated and washed down with water.

B. Persons not wearing appropriate protective equipment should be restricted from areas of spills or leaks until cleanup has been completed.

C. Waste disposal methods: Waste material should be disposed of in a manner that is not hazardous to employees or to the general population. In selecting the method of waste disposal, applicable local, State, and Federal regulations should be consulted.

IV. "Monitoring and Measurement Procedures"

A. Exposure above the Permissible Exposure Limit:

1. Eight-hour exposure evaluation: Measurements taken for the purpose of determining employee exposure under this section are best taken with consecutive samples covering the full shift. Air samples should be taken in the employee's breathing zone (air that would most nearly represent that inhaled by the employee.) 2. Monitoring techniques: The sampling and analysis under this section may be performed by collection of the EtO vapor on charcoal adsorption tubes or other composition adsorption tubes, with subsequent chemical analysis. Sampling and analysis may also be performed by instruments such as real-time continuous monitoring systems, portable direct reading instruments, or passive dosimeters as long as measurements taken using these methods accurately evaluate the concentration of EtO in employees' breathing zones.

Appendix D describes the validated method of sampling and analysis which has been tested by OSHA for use with EtO. Other available methods are also described in Appendix D. The employer has the obligation of selecting a monitoring method which meets the accuracy and precision requirements of the standard under his unique field conditions. The standard requires that the method of monitoring should be accurate, to a 95 percent confidence level, to plus or minus 25 percent for concentrations of EtO at 1 ppm, and to plus or minus 35 percent for concentrations at 0.5 ppm. In addition to the method described in Appendix D, there are numerous other methods available for monitoring for EtO in the workplace. Details on these other methods have been submitted by various companies to the rulemaking record, and are available at the OSHA Docket Office.

B. Since many of the duties relating to employee exposure are dependent on the results of measurement procedures, employers should assure that the evaluation of employee exposures is performed by a technically qualified person.

V. "Protective Clothing and Equipment"

Employees should be provided with and be required to wear appropriate protective clothing wherever there is significant potential for skin contact with liquid EtO or EtO-containing solutions. Protective clothing shall include impermeable coveralls or similar full-body work clothing, gloves, and head coverings, as appropriate to protect areas of the body which may come in contact with liquid EtO or EtO-containing solutions.

Employers should ascertain that the protective garments are impermeable to EtO. Permeable clothing, including items made of rubber, and leather shoes should not be allowed to become contaminated with liquid EtO. If permeable clothing does become contaminated, it should be immediately removed, while the employer is under an emergency deluge shower. If leather footwear or other leather garments become wet from EtO they should be discarded and not be worn again, because leather absorbs EtO and holds it against the skin.

Any protective clothing that has been damaged or is otherwise found to be defective should be repaired or replaced. Clean protective clothing should be provided to the employee as necessary to assure employee protection. Whenever impermeable clothing becomes wet with liquid EtO, it should be washed down with water before being removed by the employee. Employees are also required to wear splash-proof safety goggles where there is any possibility of EtO contacting the eyes.

VI. "Miscellaneous Precautions"

A. Store EtO in tightly closed containers in a cool, well-ventilated area and take all necessary precautions to avoid any explosion hazard.

B. Non-sparking tools must be used to open and close metal containers. These containers must be effectively grounded and bonded.

C. Do not incinerate EtO cartridges, tanks or other containers.

D. Employers should advise employees of all areas and operations where exposure to EtO occur.

VII. "Common Operations"

Common operations in which exposure to EtO is likely to occur include the following: Manufacture of EtO, surfactants, ethanolamines, glycol ethers, and specialty chemicals, and use as a sterilant in the hospital, health product and spice industries.

[58 FR 35665, July 1, 1993]

1915.1047 Appendix C

Medical surveillance guidelines for ethylene oxide (Non-mandatory).

I. "Route of Entry"

Inhalation.

II. "Toxicology"

Clinical evidence of adverse effects associated with the exposure to EtO is present in the form of increased incidence of cancer in laboratory animals (leukemia, stomach, brain), mutation in offspring in animals, and resorptions and spontaneous abortions in animals and human populations respectively. Findings in humans and experimental animals exposed to airborne concentrations of EtO also indicate damage to the genetic material (DNA). These include hemoglobin alkylation, unsecheduled DNA synthesis, sister chromatid exchange chromosomal aberration, and functional sperm abnormalities.

Ethylene oxide in liquid form can cause eye irritation and injury to the cornea, frostbite, severe irritation, and blistering of the skin upon prolonged or confined contact. Ingestion of EtO can cause gastric irritation and liver injury. Other effects from inhalation of EtO vapors include respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, dyspnea and cyanosis.

III. "Signs and Symptoms of Acute Overexposure"

The early effects of acute overexposure to EtO are nausea and vomiting, headache, and irritation of the eyes and respiratory passages. The patient may notice a "peculiar taste" in the mouth. Delayed effects can include pulmonary edema, drowsiness, weakness, and incoordination. Studies suggest that blood cell changes, an increase in chromosomal aberrations, and spontaneous abortion may also be causally related to acute overexposure to EtO.

Skin contact with liquid or gaseous EtO causes characteristic burns and possibly even an allergic-type sensitization. The edema and erythema occurring from skin contact with EtO progress to vesiculation with a tendency to coalesce into blebs with desquamation. Healing occurs within three weeks, but there may be a residual brown pigmentation. A 40-80 percent solution is extremely dangerous, causing extensive blistering after only brief contact. Pure liquid EtO causes frostbite because of rapid evaporation. In contrast, the eye is relatively insensitive to EtO, but there may be some irritation of the cornea.

Most reported acute effects of occupational exposure to EtO are due to contact with EtO in liquid phase. The liquid readily penetrates rubber and leather, and will produce blistering if clothing or footwear contaminated with EtO are not removed.

IV. "Surveillance and Preventive Considerations"

As noted above, exposure to EtO has been linked to an increased risk of cancer and reproductive effects including decreased male fertility, fetotoxicity, and spontaneous abortion. EtO workers are more likely to have chromosomal damage than similar groups not exposed to EtO. At the present, limited studies of chronic effects in humans resulting from exposure to EtO suggest a causal association with leukemia. Animal studies indicate leukemia and cancers at other sites (brain, stomach) as well. The physician should be aware of the findings of these studies in evaluating the health of employees exposed to EtO.

Adequate screening tests to determine an employee's potential for developing serious chronic diseases, such as cancer, from exposure to EtO do not presently exist. Laboratory tests may, however, give evidence to suggest that an employee is potentially overexposed to EtO. It is important for the physician to become familiar with the operating conditions in which exposure to EtO is likely to occur. The physician also must become familiar with the signs and symptoms that indicate a worker is receiving otherwise unrecognized and unacceptable exposure to EtO. These elements are especially important in evaluating the medical and work histories and in conducting the physical exam. When an unacceptable exposure in an active employee is identified by the physician, measures taken by the employer to lower exposure should also lower the risk of serious long-term consequences.

The employer is required to institute a medical surveillance program for all employees who are or will be exposed to EtO at or above the action level (0.5 ppm) for at least 30 days per year, without regard to respirator use. All examinations and procedures must be performed by or under the supervision of a licensed physician at a reasonable time and place for the employee and at no cost to the employee.

Although broad latitude in prescribing specific tests to be included in the medical surveillance program is extended to the examining physician, OSHA requires inclusion of the following elements in the routine examination:

(i) Medical and work histories with special emphasis directed to symptoms related to the pulmonary, hematologic, neurologic, and reproductive systems and to the eyes and skin.

(ii) Physical examination with particular emphasis given to the pulmonary, hematologic, neurologic, and reproductive systems and to the eyes and skin.

(iii) Complete blood count to include at least a white cell count (including differential cell count), red cell count, hematocrit, and hemoglobin.

(iv) Any laboratory or other test which the examining physician deems necessary by sound medical practice.

If requested by the employee, the medical examinations shall include pregnancy testing or laboratory evaluation of fertility as deemed appropriate by the physician.

In certain cases, to provide sound medical advice to the employer and the employee, the physician must evaluate situations not directly related to EtO. For example, employees with skin diseases may be unable to tolerate wearing protective clothing. In addition those with chronic respiratory diseases may not tolerate the wearing of negative pressure (air purifying) respirators. Additional tests and procedures that will help the physician determine which employees are medically unable to wear such respirators should include: An evaluation of cardiovascular function, a baseline chest x-ray to be repeated at five year intervals, and a pulmonary function test to be repeated every three years. The pulmonary function test should include measurement of the employee's forced vital capacity (FVC), forced expiratory volume at one second (FEV1), as well as calculation of the ratios of FEV1 to FVC, and measured FVC and measured FEV1 to expected values corrected for variation due to age, sex, race, and height.

The employer is required to make the prescribed tests available at least annually to employees who are or will be exposed at or above the action level, for 30 or more days per year; more often than specified if recommended by the examining physician; and upon the employee's termination of employment or reassignment to another work area. While little is known about the long term consequences of high short-term exposures, it appears prudent to monitor such affected employees closely in light of existing health data. The employer shall provide physician recommended examinations to any employee exposed to EtO in emergency conditions. Likewise, the employer shall make available medical consultations including physician recommended exams to employees who believe they are suffering signs or symptoms of exposure to EtO.

The employer is required to provide the physician with the following information: a copy of this standard and its appendices; a description of the affected employee's duties as they relate to the employee exposure level; and information from the employee's previous medical examinations which is not readily available to the examining physician. Making this information available to the physician will aid in the evaluation of the employee's health in relation to assigned duties and fitness to wear personal protective equipment, when required.

The employer is required to obtain a written opinion from the examining physician containing the results of the medical examinations; the physician's opinion as to whether the employee has any detected medical conditions which would place the employee at increased risk of material impairment of his or her health from exposure to EtO; any recommended restrictions upon the employee's exposure to EtO, or upon the use of protective clothing or equipment such as respirators; and a statement that the employee has been informed by the physician of the results of the medical examination and of any medical conditions which require further explanation or treatment. This written opinion must not reveal specific findings or diagnoses unrelated to occupational exposure to EtO, and a copy of the opinion must be provided to the affected employee.

The purpose in requiring the examining physician to supply the employer with a written opinion is to provide the employer with a medical basis to aid in the determination of initial placement of employees and to assess the employee's ability to use protective clothing and equipment.

[58 FR 35666, July 1, 1993]

1915.1047 Appendix D

Sampling and analytical methods for ethylene oxide (Non-mandatory).

A number of methods are available for monitoring employee exposures to EtO. Most of these involve the use of charcoal tubes and sampling pumps, followed by analysis of the samples by gas chromatograph. The essential differences between the charcoal tube methods include, among others, the use of different desorbing solvents, the use of different lots of charcoal, and the use of different equipment for analysis of the samples.

Besides charcoal, methods using passive dosimeters, gas sampling bags, impingers, and detector tubes have been utilized for determination of EtO exposure. In addition, there are several commercially available portable gas analyzers and monitoring units.

This appendix contains details for the method which has been tested at the OSHA Analytical Laboratory in Salt Lake City. Inclusion of this method in the appendix does not mean that this method is the only one which will be satisfactory. Copies of descriptions of other methods available are available in the rulemaking record, and may be obtained from the OSHA Docket Office. These include the Union Carbide, Dow Chemical, 3M, and DuPont methods, as well as NIOSH Method S-286. These methods are briefly described at the end of this appendix.

Employers who note problems with sample breakthrough using the OSHA or other charcoal methods should try larger charcoal tubes. Tubes of larger capacity are available. In addition, lower flow rates and shorter sampling times should be beneficial in minimizing breakthrough problems. Whatever method the employer chooses, he must assure himself of the method's accuracy and precision under the unique conditions present in his workplace.

ETHYLENE OXIDE

Method No.: 30. Matrix: Air. Target Concentration: 1.0 ppm (1.8 mg/m(3)).

Procedure: Samples are collected on two charcoal tubes in series and desorbed with 1 percent CS(2) in benzene. The samples are derivatized with HBr and treated with sodium carbonate. Analysis is done by gas chromatography with an electron capture detector.

Recommended Air Volume and Sampling Rate: 1 liter and 0.05 Lpm. Detection Limit of the Overall Procedure: 13.3 ppb (0.024 mg/m(3)) (Based on 1.0 liter air sample).

Reliable Quantitation Limit: 52.2 ppb (0.094 mg/m(3)) (Based on 1.0 liter air sample).

Standard Error of Estimate: 6.59 percent (See Backup Section 4.6). Special Requirements: Samples must be analyzed within 15 days of sampling date.

Status of Method: The sampling and analytical method has been subjected to the established evaluation procedures of the Organic Method Evaluations Branch.

Date: August 1981. Chemist: Wayne D. Potter.

Organic Solvents Branch, OSHA Analytical Laboratory, Salt Lake City, Utah

1. General Discussion.

1.1 Background.

1.1.1 History of Procedure. Ethylene oxide samples analyzed at the OSHA Laboratory have normally been collected on activated charcoal and desorbed with carbon disulfide. The analysis is performed with a gas chromatograph equipped with a FID (Flame ionization detector) as described in NIOSH Method S286 (Ref. 5.1). This method is based on a PEL of 50 ppm and has a detection limit of about 1 ppm.

Recent studies have prompted the need for a method to analyze and detect ethylene oxide at very low concentrations.

Several attempts were made to form an ultraviolet (UV) sensitive derivative with ethylene oxide for analysis with HPLC. Among those tested that gave no detectable product were: p-anisidine, methylimidazole, aniline, and 2,3,6-trichlorobenzoic acid. Each was tested with catalysts such as triethylamine, aluminum chloride, methylene chloride and sulfuric acid but no detectable derivative was produced.

The next derivatization attempt was to react ethylene oxide with HBr to form 2-bromoethanol. This reaction was successful. An ECD (electron capture detector) gave a very good response for 2-bromoethanol due to the presence of bromine. The use of carbon disulfide as the desorbing solvent gave too large a response and masked the 2-bromoethanol. Several other solvents were tested for both their response on the ECD and their ability to desorb ethylene oxide from the charcoal. Among those tested were toluene, xylene, ethyl benzene, hexane, cyclohexane and benzene. Benzene was the only solvent tested that gave a suitable response on the ECD and a high desorption. It was found that the desorption efficiency was improved by using 1 percent CS(2) with the benzene. The carbon disulfide did not significantly improve the recovery with the other solvents. SKC Lot 120 was used in all tests done with activated charcoal.

1.1.2 Physical Properties (Ref. 5.2-5.4).

Synonyms: Oxirane; dimethylene oxide, 1,2-epoxy-ethane; oxane; C(2)H(4)O; ETO;

Molecular Weight: 44.06 Boiling Point: 10.7 deg. C (51.3 deg.) Melting Point: -111 deg. C Description: Colorless, flammable gas Vapor Pressure: 1095 mm. at 20 deg. C Odor: Ether-like odor Lower Explosive Limits: 3.0 percent (by volume) Flash Point (TOC): Below 0 deg. F Molecular Structure: CH(2)-CH(2)

1.2 Limit Defining Parameters.

1.2.1 Detection Limit of the Analytical Procedure. The detection limit of the analytical procedure is 12.0 picograms of ethylene oxide per injection. This is the amount of analyte which will give a peak whose height is five times the height of the baseline noise. (See Backup Data Section 4.1).

1.2.2 Detection Limit of the Overall Procedure. The detection limit of the overall procedure is 24.0 ng of ethylene oxide per sample.

This is the amount of analyte spiked on the sampling device which allows recovery of an amount of analyte equivalent to the detection limit of the analytical procedure. (See Backup Data Section 4.2).

1.2.3 Reliable Quantitation Limit. The reliable quantitation limit is 94.0 nanograms of ethylene oxide per sample. This is the smallest amount of analyte which can be quantitated within the requirements of 75 percent recovery and 95 percent confidence limits. (See Backup Data Section 4.2).

It must be recognized that the reliable quantitation limit and detection limits reported in the method are based upon optimization of the instrument for the smallest possible amount of analyte. When the target concentration of an analyte is exceptionally higher than these limits, they may not be attainable at the routine operating parameters. In this case, the limits reported on analysis reports will be based on the operating parameters used during the analysis of the samples.

1.2.4 Sensitivity. The sensitivity of the analytical procedure over a concentration range representing 0.5 to 2 times the target concentration based on the recommended air volume is 34105 area units per ug/mL. The sensitivity is determined by the slope of the calibration curve (See Backup Data Section 4.3).

The sensitivity will vary somewhat with the particular instrument used in the analysis.

1.2.5 Recovery. The recovery of analyte from the collection medium must be 75 percent or greater. The average recovery from spiked samples over the range of 0.5 to 2 times the target concentration is 88.0 percent (See Backup Section 4.4). At lower concentrations the recovery appears to be non-linear.

1.2.6 Precision (Analytical Method Only). The pooled coefficient of variation obtained from replicate determination of analytical standards at 0.5X, 1X and 2X the target concentration is 0.036 (See Backup Data Section 4.5).

1.2.7 Precision (Overall Procedure). The overall procedure must provide results at the target concentration that are 25 percent of better at the 95 percent confidence level. The precision at the 95 percent confidence level for the 15 day storage test is plus or minus 12.9 percent (See Backup Data Section 4.6).

This includes an additional plus or minus 5 percent for sampling error.

1.3 Advantages.

1.3.1 The sampling procedure is convenient.

1.3.2 The analytical procedure is very sensitive and reproducible.

1.3.3 Reanalysis of samples is possible.

1.3.4 Samples are stable for at least 15 days at room temperature.

1.3.5 Interferences are reduced by the longer GC retention time of the new derivative.

1.4 Disadvantages.

1.4.1 Two tubes in series must be used because of possible breakthrough and migration.

1.4.2 The precision of the sampling rate may be limited by the reproducibility of the pressure drop across the tubes. The pumps are usually calibrated for one tube only.

1.4.3 The use of benzene as the desorption solvent increases the hazards of analysis because of the potential carcinogenic effects of benzene.

1.4.4 After repeated injections there can be a buildup of residue formed on the electron capture detector which decreases sensitivity.

1.4.5 Recovery from the charcoal tubes appears to be nonlinear at low concentrations.

2. Sampling Procedure.

2.1 Apparatus.

2.1.1 A calibrated personal sampling pump whose flow can be determined within plus or minus 5 percent of the recommended flow.

2.1.2 SKC Lot 120 Charcoal tubes: glass tube with both ends flame sealed, 7 cm long with a 6 mm O.D. and a 4-mm I.D., containing 2 sections of coconut shell charcoal separated by a 2-mm portion of urethane foam. The adsorbing section contains 100 mg of charcoal, the backup section 50 mg. A 3-mm portion of urethane foam is placed between the outlet end of the tube and the backup section. A plug of silylated glass wool is placed in front of the adsorbing section.

2.2 Reagents.

2.2.1 None required.

2.3 Sampling Technique.

2.3.1 Immediately before sampling, break the ends of the charcoal tubes.

All tubes must be from the same lot.

2.3.2 Connect two tubes in series to the sampling pump with a short section of flexible tubing. A minimum amount of tubing is used to connect the two sampling tubes together. The tube closer to the pump is used as a backup. This tube should be identified as the backup tube.

2.3.3 The tubes should be placed in a vertical position during sampling to minimize channeling.

2.3.4 Air being sampled should not pass through any hose or tubing before entering the charcoal tubes.

2.3.5 Seal the charcoal tubes with plastic caps immediately after sampling. Also, seal each sample with OSHA seals lengthwise.

2.3.6 With each batch of samples, submit at least one blank tube from the same lot used for samples. This tube should be subjected to exactly the same handling as the samples (break, seal, transport) except that no air is drawn through it.

2.3.7 Transport the samples (and corresponding paperwork) to the lab for analysis.

2.3.8 If bulk samples are submitted for analysis, they should be transported in glass containers with Teflon-lined caps. These samples must be mailed separately from the container used for the charcoal tubes.

2.4 Breakthrough.

2.4.1 The breakthrough (5 percent breakthrough) volume for a 3.0 mg/m ethylene oxide sample stream at approximately 85 percent relative humidity, 22 deg. C and 633 mm is 2.6 liters sampled at 0.05 liters per minute. This is equivalent to 7.8 mg of ethylene oxide. Upon saturation of the tube it appeared that the water may be displacing ethylene oxide during sampling.

2.5 Desorption Efficiency.

2.5.1 The desorption efficiency, from liquid injection onto charcoal tubes, averaged 88.0 percent from 0.5 to 2.0 x the target concentration for a 1.0 liter air sample. At lower ranges it appears that the desorption efficiency is non-linear (See Backup Data Section 4.2).

2.5.2 The desorption efficiency may vary from one laboratory to another and also from one lot of charcoal to another. Thus, it is necessary to determine the desorption efficiency for a particular lot of charcoal.

2.6 Recommended Air Volume and Sampling Rate.

2.6.1 The recommended air volume is 1.0 liter.

2.6.2 The recommended maximum sampling rate is 0.05 Lpm.

2.7 Interferences.

2.7.1 Ethylene glycol and Freon 12 at target concentration levels did not interfere with the collection of ethylene oxide.

2.7.2 Suspected interferences should be listed on the sample data sheets.

2.7.3 The relative humidity may affect the sampling procedure.

2.8 Safety Precautions.

2.8.1 Attach the sampling equipment to the employee so that it does not interfere with work performance.

2.8.2 Wear safety glasses when breaking the ends of the sampling tubes.

2.8.3 If possible, place the sampling tubes in a holder so the sharp end is not exposed while sampling.

3. Analytical Method.

3.1 Apparatus.

3.1.1 Gas chromatograph equipped with a linearized electron capture detector.

3.1.2 GC column capable of separating the derivative of ethylene oxide (2-bromoethanol) from any interferences and the 1 percent CS(2) in benzene solvent. The column used for validation studies was: 10 ft x 1/8 inch stainless steel 20 percent SP-2100, .1 percent Carbowax 1500 on 100/120 Supelcoport.

3.1.3 An electronic integrator or some other suitable method of measuring peak areas.

3.1.4 Two milliliter vials with Teflon-lined caps.

3.1.5 Gas tight syringe - 500 mL or other convenient sizes for preparing standards.

3.1.6 Microliter syringes - 10 mL or other convenient sizes for diluting standards and 1 mL for sample injections.

3.1.7 Pipets for dispensing the 1 percent CS(2) in benzene solvent. The Glenco 1 mL dispenser is adequate and convenient.

3.1.8 Volumetric flasks - 5 mL and other convenient sizes for preparing standards.

3.1.9 Disposable Pasteur pipets.

3.2 Reagents.

3.2.1 Benzene, reagent grade.

3.2.2 Carbon Disulfide, reagent grade.

3.2.3 Ethylene oxide, 99.7 percent pure.

3.2.4 Hydrobromic Acid, 48 percent reagent grade.

3.2.5 Sodium Carbonate, anhydrous, reagent grade.

3.2.6 Desorbing reagent, 99 percent Benzene/1 percent CS(2).

3.3 Sample Preparation.

3.3.1 The front and back sections of each sample are transferred to separate 2-mL vials.

3.3.2 Each sample is desorbed with 1.0 mL of desorbing reagent.

3.3.3 The vials are sealed immediately and allowed to desorb for one hour with occasional shaking.

3.3.4 Desorbing reagent is drawn off the charcoal with a disposable pipet and put into clean 2-mL vials.

3.3.5 One drop of HBr is added to each vial. Vials are resealed and HBr is mixed well with the desorbing reagent.

3.3.6 About 0.15 gram of sodium carbonate is carefully added to each vial. Vials are again resealed and mixed well.

3.4 Standard Preparation.

3.4.1 Standards are prepared by injecting the pure ethylene oxide gas into the desorbing reagent.

3.4.2 A range of standards are prepared to make a calibration curve. A concentration of 1.0 uL of ethylene oxide gas per 1 mL desorbing reagent is equivalent to 1.0 ppm air concentration (all gas volumes at 25 deg. C and 760 mm) for the recommended 1 liter air sample. This amount is uncorrected for desorption efficiency (See Backup Data Section 4.2. for desorption efficiency corrections).

3.4.3 One drop of HBr per mL of standard is added and mixed well.

3.4.4 About 0.15 grams of sodium carbonate is carefully added for each drop of HBr (A small reaction will occur).

3.5 Analysis.

3.5.1 GC Conditions.

Nitrogen flow rate - 10 mL/min. Injector Temperature - 250 deg. C Detector Temperature - 300 deg. C Column Temperature - 100 deg. C Injection size - 0.8 uL Elution time - 3.9 minutes

3.5.2 Peak areas are measured by an integrator or other suitable means.

3.5.3 The integrator results are in area units and a calibration curve is set up with concentration vs. area units.

3.6 Interferences.

3.6.1 Any compound having the same retention time of 2-bromoethanol is a potential interference. Possible interferences should be listed on the sample data sheets.

3.6.2 GC parameters may be changed to circumvent interferences.

3.6.3 There are usually trace contaminants in benzene. These contaminants, however, posed no problem of interference.

3.6.4 Retention time data on a single column is not considered proof of chemical identity. Samples over the 1.0 ppm target level should be confirmed by GC/Mass Spec or other suitable means.

3.7 Calculations

3.7.1 The concentration in ug/mL for a sample is determined by comparing the area of a particular sample to the calibration curve, which has been prepared from analytical standards.

3.7.2 The amount of analyte in each sample is corrected for desorption efficiency by use of a desorption curve.

3.7.3 Analytical results (A) from the two tubes that compose a particular air sample are added together.

3.7.4 The concentration for a sample is calculated by the following equation:

ETO, mg/m(3) = AXB/C

where:

A = ug/mL B = desorption volume in milliliters C = air volume in liters.

3.7.5 To convert mg/m(3) to parts per million (ppm) the following relationship is used:

ETO, ppm = mg/m(3) X 24.45/44.05

where:

mg/m(3) = results from 3.7.4 24.45 = molar volume at 25 deg. C and 760 mm Hg 44.05 = molecular weight of ETO.

3.8 Safety Precautions

3.8.1 Ethylene oxide and benzene are potential carcinogens and care must be exercised when working with these compounds.

3.8.2 All work done with the solvents (preparation of standards, desorption of samples, etc.) should be done in a hood.

3.8.3 Avoid any skin contact with all of the solvents.

3.8.4 Wear safety glasses at all times.

3.8.5 Avoid skin contact with HBr because it is highly toxic and a strong irritant to eyes and skin.

4. Backup Data.

4.1 Detection Limit Data. The detection limit was determined by injecting 0.8 uL of a 0.015 ug/mL standard of ethylene oxide into 1 percent CS(2) in benzene. The detection limit of the analytical procedure is taken to be 1.20 X 10(-5) ug per injection. This is equivalent to 8.3 ppb (0.015 mg/m(3)) for the recommended air volume.

4.2 Desorption Efficiency. Ethylene oxide was spiked onto charcoal tubes and the following recovery data was obtained.

Amount spiked (ug)	Amount recovered (ug)	Percent recovery
4.5	4.32	96.0
3.0	2.61	87.0
2.25	2.025	90.0
1.5	1.365	91.0
1.5	1.38	92.0
.75	.6525	87.0
.375	.315	84.0
.375	.312	83.2
.1875	.151	80.5
.094	.070	74.5

At lower amounts the recovery appears to be non-linear. 4.3 Sensitivity Data. The following data was used to determine the calibration curve.

Injection	0.5 X .75 ug/mL	1 X 1.5 ug/mL	2 X 3.0 ug/mL
1	30904	59567	111778
2	30987	62914	106016
3	32555	58578	106122
4	32242	57173	109716
X	31672	59558	108408

Slope = 34.105.

4.4 Recovery. The recovery was determined by spiking ethylene oxide onto lot 120 charcoal tubes and desorbing with 1 percent CS(2) in Benzene. Recoveries were done at 0.5, 1.0, and 2.0 X the target concentration (1 ppm) for the recommended air volume.

PERCENT RECOVERY

_________________________________________

Sample	0.5x	1.0x	2.0x
1	88.7	95.0	91.7
2	83.8	95.0	87.3
3	84.2	91.0	86.0
4	88.0	91.0	83.0
5	88.0	86.0	85.0
X	86.5	90.5	87.0

Weighted Average = 88.2. 4.5 Precision of the Analytical Procedure.

The following data was used to determine the precision of the analytical method:

Concentration	0.5x.75 ug/mL	1x1.5 ug/mL	2X3.0 ug/mL
Injection	.7421	1.4899	3.1184
	.7441	1.5826	3.0447
	.7831	1.4628	2.9149
	.7753	1.4244	2.9185
Average	.7612	1.4899	2.9991
Standard Deviation	.0211	.0674	.0998
CV	.0277	.0452	.0333

3(.0277)(squared) + 3(.0452)(squared) + 3(.0333)(squared) CV = ___________________________________________________________ 3 + 3 + 3

CV + 0.036

4.6 Storage Data. Samples were generated at 1.5 mg/m(3) ethylene oxide at 85 percent relative humidity, 22 deg. C and 633 mm. All samples were taken for 20 minutes at 0.05 Lpm. Six samples were analyzed as soon as possible and fifteen samples were stored at refrigerated temperature (5 deg. C) and fifteen samples were stored at ambient temperature (23 deg. C). These stored samples were analyzed over a period of nineteen days.

PERCENT RECOVERY

Day analyzed	Refrigerated	Ambient
1	87.0	87.0
1	93.0	93.0
1	94.0	94.0
1	92.0	92.0
4	92.0	91.0
4	93.0	88.0
4	91.0	89.0
6	92.0
6	92.0
8		92.0
8		86.0
10	91.7
10	95.5
10	95.7
11		90.0
11		82.0
13	78.0
13	81.4
13	82.4
14		78.5
14		72.1
18	66.0
18	68.0
19		64.0
19		77.0

4.7 Breakthrough Data. Breakthrough studies were done at 2 ppm (3.6 mg/m(3)) at approximately 85 percent relative humidity at 22 deg.C (ambient temperature). Two charcoal tubes were used in series. The backup tube was changed every 10 minutes and analyzed for breakthrough. The flow rate was 0.050 Lpm.

Tube No.	Time (minutes)	Percent break-through
1	10	(1)
2	20	(1)
3	30	(1)
4	40	1.23
5	50	3.46
6	60	18.71
7	70	39.2
8	80	53.3
9	90	72.0
10	100	96.0
11	110	113.0
12	120	133.9

Footnote(1) None.

The 5 percent breakthrough volume was reached when 2.6 liters of test atmosphere were drawn through the charcoal tubes.

5. References.

5.1 "NIOSH Manual of Analytical Methods," 2nd ed. NIOSH: Cincinnati, 1977; Method S286.

5.2 "IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man," International Agency for Research on Cancer: Lyon, 1976; Vol. II, p. 157.

5.3 Sax., N.I. "Dangerous Properties of Industrial Materials," 4th ed.; Van Nostrand Reinhold Company. New York, 1975; p. 741.

5.4 "The Condensed Chemical Dictionary", 9th ed.; Hawley, G.G., ed.; Van Nostrand Reinhold Company, New York, 1977; p. 361.

"Summary of Other Sampling Procedures"

OSHA believes that served other types of monitoring equipment and techniques exist for monitoring time-weighted averages. Considerable research and method development is currently being performed, which will lead to improvements and a wider variety of monitoring techniques. A combination of monitoring procedures can be used. There probably is no one best method for monitoring personal exposure to ethylene oxide in all cases. There are advantages, disadvantages, and limitations to each method. The method of choice will depend on the need and requirements. Some commonly used methods include the use of charcoal tubes, passive dosimeters, Tedler gas sampling bags, detector tubes, photoionization detection units, infrared detection units and gas chromatographs. A number of these methods are described below.

A. Charcoal Tube Sampling Procedures

"Qazi-Ketcham method" (Ex. 11-133) - This method consists of collecting EtO on Columbia JXC activated carbon, desorbing the EtO with carbon disulfide and analyzing by gas chromatography with flame ionization detection. Union Carbide has recently updated and revalidated this monitoring procedures. This method is capable of determining both eight-hour time-weighted average exposures and short-term exposures. The method was validated to 0.5 ppm. Like other charcoal collecting procedures, the method requires considerable analytical expertise.

"ASTM-proposed method" - The Ethylene Oxide Industry Council (EOIC) has contracted with Clayton Environmental Consultants, Inc. to conduct a collaborative study for the proposed method. The ASTM-Proposed method is similar to the method published by Qazi and Ketcham is the November 1977 American Industrial Hygiene Association Journal, and to the method of Pilney and Coyne, presented at the 1979 American Industrial Hygiene Conference. After the air to be sampled is drawn through an activated charcoal tube, the ethylene oxide is desorbed from the tube using carbon disulfide and is quantitated by gas chromatography utilizing a flame ionization detector. The ASTM-proposed method specifies a large two-section charcoal tube, shipment in dry ice, storage at less than -5 deg.C, and analysis within three weeks to prevent migration and sample loss. Two types of charcoal tubes are being tested-Pittsburgh Coconut-Based (PCB) and Columbia JXC charcoal. This collaborative study will give an indication of the inter- and intralaboratory precision and accuracy of the ASTM-proposed method. Several laboratories have considerable expertise using the Qazi-Ketcham and Dow methods.

B. Passive Monitors - Ethylene oxide diffuses into the monitor and is collected in the sampling media. The DuPont Pro-Tek badge collects EtO in an absorbing solution, which is analyzed colorimetrically to determine the amount of EtO present. The 3M 350 badge collects the EtO on chemically treated charcoal. Other passive monitors are currently being developed and tested. Both 3M and DuPont have submitted data indicating their dosimeters meet the precision and accuracy requirements of the proposed ethylene oxide standard. Both presented laboratory validation data to 0.2 ppm (Exs. 11-65, 4-20, 108, 109, 130).

C. Tedlar Gas Sampling Bags - Samples are collected by drawing a known volume of air into a Tedlar gas sampling bag. The ethylene oxide concentration is often determined on-site using a portable gas chromatograph or portable infrared spectometer.

D. Detector tubes - A known volume of air is drawn through a detector tube using a small hand pump. The concentration of EtO is related to the length of stain developed in the tube. Detector tubes are economical, easy to use, and give an immediate readout. Unfortunately, partly because they are nonspecific, their accuracy is often questionable. Since the sample is taken over a short period of time, they may be useful for determining the source of leaks.

E. Direct Reading Instruments - There are numerous types of direct reading instruments, each having its own strengths and weaknesses (Exs. 135B, 135C, 107, 11-78, 11-153). Many are relatively new, offering greater sensitivity and specificity. Popular ethylene oxide direct reading instruments include infrared detection units, photoionization detection units, and gas chromatographs.

Portable infrared analyzers provide an immediate, continuous indication of a concentration value; making them particularly useful for locating high concentration pockets, in leak detection and in ambient air monitoring. In infrared detection units, the amount of infrared light absorbed by the gas being analyzed at selected infrared wavelengths is related to the concentration of a particular component. Various models have either fixed or variable infrared filters, differing cell pathlengths, and microcomputer controls for greater sensitivity, automation, and interference elimination.

A fairly recent detection system is photoionization detection. The molecules are ionized by high energy ultraviolet light. The resulting current is measured. Since different substances have different ionization potentials, other organic compounds may be ionized. The lower the lamp energy, the better the selectivity. As a continuous monitor, photoionization detection can be useful for locating high concentration pockets, in leak detection, and continuous ambient air monitoring. Both portable and stationary gas chromatographs are available with various types of detectors, including photoionization detectors. A gas chromatograph with a photoionization detector retains the photoionization sensitivity, but minimizes or eliminates interferences. For several GC/PID units, the sensitivity is in the 0.1-0.2 ppm EtO range. The GC/PID with microprocessors can sample up to 20 sample points sequentially, calculate and record data, and activate alarms or ventilation systems. Many are quite flexible and can be configured to meet the specific analysis needs for the workplace.

DuPont presented their laboratory validation data of the accuracy of the Qazi-Ketcham charcoal tube, the PCB charcoal tube, Miran 103 IR analyzer, 3M #3550 monitor and the Du Pont C-70 badge. Quoting Elbert V. Kring:

We also believe that OSHA's proposed accuracy in this standard is appropriate. At plus or minus 25 percent at one part per million, and plus or minus 35 percent below that. And, our data indicates there's only one monitoring method, right now, that we've tested thoroughly, that meets that accuracy requirements. That is the Du Pont Pro-Tek badge. . .. We also believe that this kind of data should be confirmed by another independent laboratory, using the same type dynamic chamber testing (Tr. 1470)

Additional data by an independent laboratory following their exact protocol was not submitted. However, information was submitted on comparisons and precision and accuracy of those monitoring procedures which indicate far better precision and accuracy of those monitoring procedures than that obtained by Du Pont (Ex. 4-20, 130, 11-68, 11-133, 130, 135A).

The accuracy of any method depends to a large degree upon the skills and experience of those who not only collect the samples but also those who analyze the samples. Even for methods that are collaboratively tested, some laboratories are closer to the true values than others. Some laboratories may meet the precision and accuracy requirements of the method; others may consistently far exceed them for the same method.

[58 FR 35667, July 1, 1993]

1915.1048 Formaldehyde.

(a) "Scope and application." This standard applies to all occupational exposures to formaldehyde, i.e. from formaldehyde gas, its solutions, and materials that release formaldehyde.

(b) "Definitions." For purposes of this standard, the following definitions shall apply:

"Action level" means a concentration of 0.5 part formaldehyde per million parts of air (0.5 ppm) calculated as an eight (8)-hour time-weighted average (TWA) concentration.

"Assistant Secretary" means the Assistant Secretary of Labor for the Occupational Safety and Health Administration, U.S. Department of Labor, or designee.

"Authorized person" means any person required by work duties to be present in regulated areas, or authorized to do so by the employer, by this section, or by the OSH Act of 1970.

"Director" means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee.

"Emergency" is any occurrence, such as but not limited to equipment failure, rupture of containers, or failure of control equipment that results in an uncontrolled release of a significant amount of formaldehyde.

"Employee exposure" means the exposure to airborne formaldehyde which would occur without corrections for protection provided by any respirator that is in use.

"Formaldehyde" means the chemical substance, HCHO, Chemical Abstracts Service Registry No. 50-00-0.

(c) "Permissible Exposure Limit (PEL)" - (1) "TWA:" The employer shall assure that no employee is exposed to an airborne concentration of formaldehyde which exceeds 0.75 parts formaldehyde per million parts of air (0.75 ppm) as an 8-hour TWA.

(2) "Short Term Exposure Limit (STEL):" The employer shall assure that no employee is exposed to an airborne concentration of formaldehyde which exceeds two parts formaldehyde per million parts of air (2 ppm) as a 15-minute STEL.

(d) "Exposure monitoring" - (1) "General." (i) Each employer who has a workplace covered by this standard shall monitor employees to determine their exposure to formaldehyde.

(ii) "Exception." Where the employer documents, using objective data, that the presence of formaldehyde or formaldehyde-releasing products in the workplace cannot result in airborne concentrations of formaldehyde that would cause any employee to be exposed at or above the action level or the STEL under foreseeable conditions of use, the employer will not be required to measure employee exposure to formaldehyde.

(iii) When an employee's exposure is determined from representative sampling, the measurements used shall be representative of the employee's full shift or short-term exposure to formaldehyde, as appropriate.

(iv) Representative samples for each job classification in each work area shall be taken for each shift unless the employer can document with objective data that exposure levels for a given job classification are equivalent for different work shifts.

(2) "Initial monitoring." The employer shall identify all employees who may be exposed at or above the action level or at or above the STEL and accurately determine the exposure of each employee so identified.

(i) Unless the employer chooses to measure the exposure of each employee potentially exposed to formaldehyde, the employer shall develop a representative sampling strategy and measure sufficient exposures within each job classification for each workshift to correctly characterize and not underestimate the exposure of any employee within each exposure group.

(ii) The initial monitoring process shall be repeated each time there is a change in production, equipment, process, personnel, or control measures which may result in new or additional exposure to formaldehyde.

(iii) If the employer receives reports of signs or symptoms of respiratory or dermal conditions associated with formaldehyde exposure, the employer shall promptly monitor the affected employee's exposure.

(3) "Periodic monitoring." (i) The employer shall periodically measure and accurately determine exposure to formaldehyde for employees shown by the initial monitoring to be exposed at or above the action level or at or above the STEL.

(ii) If the last monitoring results reveal employee exposure at or above the action level, the employer shall repeat monitoring of the employees at least every 6 months.

(iii) If the last monitoring results reveal employee exposure at or above the STEL, the employer shall repeat monitoring of the employees at least once a year under worst conditions.

(4) "Termination of monitoring." The employer may discontinue periodic monitoring for employees if results from two consecutive sampling periods taken at least 7 days apart show that employee exposure is below the action level and the STEL. The results must be statistically representative and consistent with the employer's knowledge of the job and work operation.

(5) "Accuracy of monitoring." Monitoring shall be accurate, at the 95 percent confidence level, to within plus or minus 25 percent for airborne concentrations of formaldehyde at the TWA and the STEL and to within plus or minus 35 percent for airborne concentrations of formaldehyde at the action level.

(6) "Employee notification of monitoring results." Within 15 days of receiving the results of exposure monitoring conducted under this standard, the employer shall notify the affected employees of these results. Notification shall be in writing, either by distributing copies of the results to the employees or by posting the results. If the employee exposure is over either PEL, the employer shall develop and implement a written plan to reduce employee exposure to or below both PELs, and give written notice to employees. The written notice shall contain a description of the corrective action being taken by the employer to decrease exposure.

(7) "Observation of monitoring." (i) The employer shall provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to formaldehyde required by this standard.

(ii) When observation of the monitoring of employee exposure to formaldehyde requires entry into an area where the use of protective clothing or equipment is required, the employer shall provide the clothing and equipment to the observer, require the observer to use such clothing and equipment, and assure that the observer complies with all other applicable safety and health procedures.

(e) "Regulated areas." (1) The employer shall establish regulated areas where the concentration of airborne formaldehyde exceeds either the TWA or the STEL and post all entrances and accessways with signs bearing the following information:

DANGER
FORMALDEHYDE

IRRITANT AND POTENTIAL CANCER HAZARD
AUTHORIZED PERSONNEL ONLY

(2) The employer shall limit access to regulated areas to authorized persons who have been trained to recognize the hazards of formaldehyde.

(3) An employer at a multiemployer worksite who establishes a regulated area shall communicate the access restrictions and locations of these areas to other employers with work operations at that worksite.

(f) "Methods of compliance" - (1) "Engineering controls and work practices." The employer shall institute engineering and work practice controls to reduce and maintain employee exposures to formaldehyde at or below the TWA and the STEL.

(2) "Exception." Whenever the employer has established that feasible engineering and work practice controls cannot reduce employee exposure to or below either of the PELs, the employer shall apply these controls to reduce employee exposures to the extent feasible and shall supplement them with respirators which satisfy this standard.

(g) "Respiratory protection" - (1) "General." Where respiratory protection is required, the employer shall provide the respirators at no cost to the employee and shall assure that they are properly used. The respirators shall comply with the requirements of this standard and shall reduce the concentration of formaldehyde inhaled by the employee to at or below both the TWA and the STEL. Respirators shall be used in the following circumstances:

(i) During the interval necessary to install or implement feasible engineering and work practice controls;

(ii) In work operations, such as maintenance and repair activities or vessel cleaning, for which the employer establishes that engineering and work practice controls are not feasible;

(iii) In work situations where feasible engineering and work practice controls are not yet sufficient to reduce exposure to or below the PELs; and (iv) In emergencies. (2) "Respirator selection." (i) The appropriate respirators as specified in Table 1 shall be selected from those approved by the Mine Safety and Health Administration (MSHA) and by the National Institute for Occupational Safety and Health (NIOSH) under the provisions of 30 CFR Part 11.

TABLE 1. - MINIMUM REQUIREMENTS FOR RESPIRATORY
PROTECTION AGAINST FORMALDEHYDE

________________________________________________________________________ Condition of use or | formaldehyde | Minimum respirator required (1) concentration (ppm) | _____________________|___________________________________________________ Up to 7.5 ppm | (10 x PEL)........ | Full facepiece with cartridges or canisters | specifically approved for protection against | formaldehyde.(2) Up to 75 ppm | (100 x PEL)....... | Full-face mask with chin style or chest or back | mounted type, with industrial size canister | specifically approved for protection against | formaldehyde. Type C supplied air respirator, | demand type, or continuous flow type, with full | facepiece, hood, or helmet. Above 75 ppm or | unknown | (emergencies) | 100 x PEL)....... | Self-contained breathing apparatus (SCBA) with | positive pressure full facepiece. Combination | supplied-air, full facepiece positive pressure | respirator with auxiliary self-contained air | supply. Firefighting ....... | SCBA with positive pressure in full face-piece. Escape ............. | SCBA in demand or pressure demand mode. Full-face | mask with chin style or front or back mounted | type industrial size canister specifically | approved for protection against formaldehyde. _____________________|___________________________________________________

Footnote(1) Respirators specified for use at higher concentrations may be used at lower concentrations.

Footnote(2) A half-mask respirator with cartridges specifically approved for protection against formaldehyde can be substituted for the full facepiece respirator providing that effective gas-proof goggles are provided and used in combination with the half-mask respirator.

(ii) The employer shall make available a powered air-purifying respirator adequate to protect against formaldehyde exposure to any employee who experiences difficulty wearing a negative pressure respirator to reduce exposure to formaldehyde.

(3) "Respirator usage." (i) Whenever respirator use is required by this standard, the employer shall institute a respiratory protection program in accordance with 29 CFR 1910.134(b), (d), (e), and (f).

(ii) The employer shall perform either quantitative or qualitative face fit tests in accordance with the procedures outlined in Appendix E at the time of initial fitting and at least annually thereafter for all employees required by this standard to wear negative pressure respirators.

(A) Respirators selected shall be from those exhibiting the best facepiece fit.

(B) No respirator shall be chosen that would potentially permit the employee to inhale formaldehyde at concentrations in excess of either the TWA or the STEL.

(iii) Where air purifying chemical cartridge respirators are used, the cartridges shall be replaced after three hours of use or at the end of the workshift, whichever is sooner unless the cartridge contains a NIOSH-approved end-of-service indicator to show when breakthrough occurs.

(iv) Unless the canister contains a NIOSH-approved end-of- service-life indicator to show when breakthrough occurs, canisters used in atmospheres up to 7.5 ppm (10 x PEL) shall be replaced every 4 hours and industrial sized canisters used in atmospheres up to 75 ppm (100 x PEL) shall be replaced every two hours or at the end of the workshift, whichever is sooner.

(v) Employers shall permit employees to leave the work area to wash their faces and respirator facepieces as needed to prevent skin irritation from respirator use.

(h) "Protective equipment and clothing." Employers shall comply with the provisions of 29 CFR 1910.132 and 29 CFR 1910.133. When protective equipment or clothing is provided under these provisions, the employer shall provide these protective devices at no cost to the employee and assure that the employee wears them.

(1) "Selection." The employer shall select protective clothing and equipment based upon the form of formaldehyde to be encountered, the conditions of use, and the hazard to be prevented.

(i) All contact of the eyes and skin with liquids containing 1 percent or more formaldehyde shall be prevented by the use of chemical protective clothing made of material impervious to formaldehyde and the use of other personal protective equipment, such as goggles and face shields, as appropriate to the operation.

(ii) Contact with irritating or sensitizing materials shall be prevented to the extent necessary to eliminate the hazard.

(iii) Where a face shield is worn, chemical safety goggles are also required if there is a danger of formaldehyde reaching the area of the eye.

(iv) Full body protection shall be worn for entry into areas where concentrations exceed 100 ppm and for emergency reentry into areas of unknown concentration.

(2) "Maintenance of protective equipment and clothing." (i) The employer shall assure that protective equipment and clothing that has become contaminated with formaldehyde is cleaned or laundered before its reuse.

(ii) When ventilating formaldehyde-contaminated clothing and equipment, the employer shall establish a storage area so that employee exposure is minimized. Containers for contaminated clothing and equipment and storage areas shall have labels and signs containing the following information:

DANGER FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT AVOID INHALATION AND SKIN CONTACT

(iii) The employer shall assure that only persons trained to recognize the hazards of formaldehyde remove the contaminated material from the storage area for purposes of cleaning, laundering, or disposal.

(iv) The employer shall assure that no employee takes home equipment or clothing that is contaminated with formaldehyde.

(v) The employer shall repair or replace all required protective clothing and equipment for each affected employee as necessary to assure its effectiveness.

(vi) The employer shall inform any person who launders, cleans, or repairs such clothing or equipment of formaldehyde's potentially harmful effects and of procedures to safely handle the clothing and equipment.

(i) "Hygiene protection." (1) The employer shall provide change rooms, as described in 29 CFR 1910.141 for employees who are required to change from work clothing into protective clothing to prevent skin contact with formaldehyde.

(2) If employees' skin may become splashed with solutions containing 1 percent or greater formaldehyde, for example, because of equipment failure or improper work practices, the employer shall provide conveniently located quick drench showers and assure that affected employees use these facilities immediately.

(3) If there is any possibility that an employee's eyes may be splashed with solutions containing 0.1 percent or greater formaldehyde, the employer shall provide acceptable eyewash facilities within the immediate work area for emergency use.

(j) "Housekeeping." For operations involving formaldehyde liquids or gas, the employer shall conduct a program to detect leaks and spills, including regular visual inspections.

(1) Preventative maintenance of equipment, including surveys for leaks, shall be undertaken at regular intervals.

(2) In work areas where spillage may occur, the employer shall make provisions to contain the spill, to decontaminate the work area, and to dispose of the waste.

(3) The employer shall assure that all leaks are repaired and spills are cleaned promptly by employees wearing suitable protective equipment and trained in proper methods for cleanup and decontamination.

(4) Formaldehyde-contaminated waste and debris resulting from leaks or spills shall be placed for disposal in sealed containers bearing a label warning of formaldehyde's presence and of the hazards associated with formaldehyde.

(k) "Emergencies." For each workplace where there is the possibility of an emergency involving formaldehyde, the employer shall assure appropriate procedures are adopted to minimize injury and loss of life. Appropriate procedures shall be implemented in the event of an emergency.

(l) "Medical surveillance" - (1) "Employees covered." (i) The employer shall institute medical surveillance programs for all employees exposed to formaldehyde at concentrations at or exceeding the action level or exceeding the STEL.

(ii) The employer shall make medical surveillance available for employees who develop signs and symptoms of overexposure to formaldehyde and for all employees exposed to formaldehyde in emergencies. When determining whether an employee may be experiencing signs and symptoms of possible overexposure to formaldehyde, the employer may rely on the evidence that signs and symptoms associated with formaldehyde exposure will occur only in exceptional circumstances when airborne exposure is less than 0.1 ppm and when formaldehyde is present in material in concentrations less than 0.1 percent.

(2) "Examination by a physician." All medical procedures, including administration of medical disease questionnaires, shall be performed by or under the supervision of a licensed physician and shall be provided without cost to the employee, without loss of pay, and at a reasonable time and place.

(3) "Medical disease questionnaire." The employer shall make the following medical surveillance available to employees prior to assignment to a job where formaldehyde exposure is at or above the action level or above the STEL and annually thereafter. The employer shall also make the following medical surveillance available promptly upon determining that an employee is experiencing signs and symptoms indicative of possible overexposure to formaldehyde.

(i) Administration of a medical disease questionnaire, such as in Appendix D, which is designed to elicit information on work history, smoking history, any evidence of eye, nose, or throat irritation; chronic airway problems or hyperreactive airway disease: allergic skin conditions or dermatitis; and upper or lower respiratory problems.

(ii) A determination by the physician, based on evaluation of the medical disease questionnaire, of whether a medical examination is necessary for employees not required to wear respirators to reduce exposure to formaldehyde.

(4) "Medical examinations." Medical examinations shall be given to any employee who the physician feels, based on information in the medical disease questionnaire, may be at increased risk from exposure to formaldehyde and at the time of initial assignment and at least annually thereafter to all employees required to wear a respirator to reduce exposure to formaldehyde. The medical examination shall include:

(i) A physical examination with emphasis on evidence of irritation or sensitization of the skin and respiratory system, shortness of breath, or irritation of the eyes.

(ii) Laboratory examinations for respirator wearers consisting of baseline and annual pulmonary function tests. As a minimum, these tests shall consist of forced vital capacity (FVC), forced expiratory volume in one second (FEV(1)), and forced expiratory flow (FEF).

(iii) Any other test which the examining physician deems necessary to complete the written opinion.

(iv) Counseling of employees having medical conditions that would be directly or indirectly aggravated by exposure to formaldehyde on the increased risk of impairment of their health.

(5) "Examinations for employees exposed in an emergency." The employer shall make medical examinations available as soon as possible to all employees who have been exposed to formaldehyde in an emergency.

(i) The examination shall include a medical and work history with emphasis on any evidence of upper or lower respiratory problems, allergic conditions, skin reaction or hypersensitivity, and any evidence of eye, nose, or throat irritation.

(ii) Other examinations shall consist of those elements considered appropriate by the examining physician.

(6) "Information provided to the physician." The employer shall provide the following information to the examining physician:

(i) A copy of this standard and Appendix A, C, D, and E;

(ii) A description of the affected employee's job duties as they relate to the employee's exposure to formaldehyde;

(iii) The representative exposure level for the employee's job assignment;

(iv) Information concerning any personal protective equipment and respiratory protection used or to be used by the employee; and

(v) Information from previous medical examinations of the affected employee within the control of the employer.

(vi) In the event of a nonroutine examination because of an emergency, the employer shall provide to the physician as soon as possible: a description of how the emergency occurred and the exposure the victim may have received.

(7) "Physician's written opinion." (i) For each examination required under this standard, the employer shall obtain a written opinion from the examining physician. This written opinion shall contain the results of the medical examination except that it shall not reveal specific findings or diagnoses unrelated to occupational exposure to formaldehyde. The written opinion shall include:

(A) The physician's opinion as to whether the employee has any medical condition that would place the employee at an increased risk of material impairment of health from exposure to formaldehyde;

(B) Any recommended limitations on the employee's exposure or changes in the use of personal protective equipment, including respirators;

(C) A statement that the employee has been informed by the physician of any medical conditions which would be aggravated by exposure to formaldehyde, whether these conditions may have resulted from past formaldehyde exposure or from exposure in an emergency, and whether there is a need for further examination or treatment.

(ii) The employer shall provide for retention of the results of the medical examination and tests conducted by the physician.

(iii) The employer shall provide a copy of the physician's written opinion to the affected employee within 15 days of its receipt.

(8) "Medical removal." (i) The provisions of paragraph (l)(8) apply when an employee reports significant irritation of the mucosa of the eyes or of the upper airways, respiratory sensitization, dermal irritation, or dermal sensitization attributed to workplace formaldehyde exposure. Medical removal provisions do not apply in the case of dermal irritation or dermal sensitization when the product suspected of causing the dermal condition contains less than 0.05 percent formaldehyde.

(ii) An employee's report of signs or symptoms of possible overexposure to formaldehyde shall be evaluated by a physician selected by the employer pursuant to paragraph (l)(3). If the physician determines that a medical examination is not necessary under paragraph (l)(3)(ii), there shall be a two-week evaluation and remediation period to permit the employer to ascertain whether the signs or symptoms subside untreated or with the use of creams, gloves, first aid treatment or personal protective equipment. Industrial hygiene measures that limit the employee's exposure to formaldehyde may also be implemented during this period. The employee shall be referred immediately to a physician prior to expiration of the two-week period if the signs or symptoms worsen. Earnings, seniority and benefits may not be altered during the two-week period by virtue of the report.

(iii) If the signs or symptoms have not subsided or been remedied by the end of the two-week period, or earlier if signs or symptoms warrant, the employee shall be examined by a physician selected by the employer. The physician shall presume, absent contrary evidence, that observed dermal irritation or dermal sensitization are not attributable to formaldehyde when products to which the affected employee is exposed contain less than 0.1 percent formaldehyde.

(iv) Medical examinations shall be conducted in compliance with the requirements of paragraph (l)(5)(i) and (ii). Additional guidelines for conducting medical exams are contained in Appendix C.

(v) If the physician finds that significant irritation of the mucosa of the eyes or of the upper airways, respiratory sensitization, dermal irritation, or dermal sensitization result from workplace formaldehyde exposure and recommends restrictions or removal, the employer shall promptly comply with the restrictions or recommendation of removal. In the event of a recommendation of removal, the employer shall remove the affected employee from the current formaldehyde exposure and if possible, transfer the employee to work having no or significantly less exposure to formaldehyde.

(vi) When an employee is removed pursuant to paragraph (l)(8)(v), the employer shall transfer the employee to comparable work for which the employee is qualified or can be trained in a short period (up to 6 months), where the formaldehyde exposures are as low as possible, but not higher than the action level. The employer shall maintain the employee's current earnings, seniority, and other benefits. If there is no such work available, the employer shall maintain the employee's current earnings, seniority and other benefits until such work becomes available, until the employee is determined to be unable to return to workplace formaldehyde exposure, until the employee is determined to be able to return to the original job status, or for six months, whichever comes first.

(vii) The employer shall arrange for a follow-up medical examination to take place within six months after the employee is removed pursuant to this paragraph. This examination shall determine if the employee can return to the original job status, or if the removal is to be permanent. The physician shall make a decision within six months of the date the employee was removed as to whether the employee can be returned to the original job status, or if the removal is to be permanent.

(viii) An employer's obligation to provide earnings, seniority and other benefits to a removed employee may be reduced to the extent that the employee receives compensation for earnings lost during the period of removal either from a publicly or employer-funded compensation program or from employment with another employer made possible by virtue of the employee's removal.

(ix) In making determinations of the formaldehyde content of materials under this paragraph the employer may rely on objective data.

(9) "Multiple physician review." (i) After the employer selects the initial physician who conducts any medical examination or consultation to determine whether medical removal or restriction is appropriate, the employee may designate a second physician to review any findings, determinations or recommendations of the initial physician and to conduct such examinations, consultations,and laboratory tests as the second physician deems necessary and appropriate to evaluate the effects of formaldehyde exposure and to facilitate this review.

(iii) The employer may condition its participation in, and payment for, the multiple physician review mechanism upon the employee doing the following within fifteen (15) days after receipt of the notification of the right to seek a second medical opinion, or receipt of the initial physician's written opinion, whichever is later;

(A) The employee informs the employer of the intention to seek a second medical opinion, and (B) The employee initiates steps to make an appointment with a second physician.

(iv) If the findings, determinations or recommendations of the second physician differ from those of the initial physician, then the employer and the employee shall assure that efforts are made for the two physicians to resolve the disagreement. If the two physicians are unable to quickly resolve their disagreement, then the employer and the employee through their respective physicians shall designate a third physician who shall be a specialist in the field at issue:

(A) To review the findings, determinations or recommendations of the prior physicians; and

(B) To conduct such examinations, consultations, laboratory tests and discussions with the prior physicians as the third physician deems necessary to resolve the disagreement of the prior physicians.

(v) In the alternative, the employer and the employee or authorized employee representative may jointly designate such third physician.

(vi) The employer shall act consistent with the findings, determinations and recommendations of the third physician, unless the employer and the employee reach an agreement which is otherwise consistent with the recommendations of at least one of the three physicians.

(m) "Hazard communication" - (1) "General." Communication of the hazards associated with formaldehyde in the workplace shall be governed by the requirements of paragraph (m). The definitions of 29 CFR 1915.1200 (c) shall apply under this paragraph.

(i) The following shall be subject to the hazard communication requirements of this paragraph: formaldehyde gas, all mixtures or solutions composed of greater than 0.1 percent formaldehyde, and materials capable of releasing formaldehyde into the air, under reasonably foreseeable conditions of use, at concentrations reaching or exceeding 0.1 ppm.

(ii) As a minimum, specific health hazards that the employer shall address are: cancer, irritation and sensitization of the skin and respiratory system, eye and throat irritation, and acute toxicity.

(2) Manufacturers and importers who produce or import formaldehyde or formaldehyde-containing products shall provide downstream employers using or handling these products with an objective determination through the required labels and MSDSs if these items may constitute a health hazard within the meaning of 29 CFR 1915.1200(d) under normal conditions of use.

(3) "Labels." (i) The employer shall assure that hazard warning labels complying with the requirements of 29 CFR 1915.1200(f) are affixed to all containers of materials listed in paragraph (m)(1)(i), except to the extent that 29 CFR 1915.1200(f) is inconsistent with this paragraph.

(ii) "Information on labels." As a minimum, for all materials listed in paragraph (m)(1)(i) capable of releasing formaldehyde at levels of 0.1 ppm to 0.5 ppm, labels shall identify that the product contains formaldehyde; list the name and address of the responsible party; and state that physical and health hazard information is readily available from the employer and from material safety data sheets.

(iii) For materials listed in paragraph (m)(1)(i) capable of releasing formaldehyde at levels above 0.5 ppm, labels shall appropriately address all hazards as defined in 29 CFR 1915.1200 (d) and 29 CFR 1915.1200 appendices A and B, including respiratory sensitization, and shall contain the words "Potential Cancer Hazard."

(iv) In making the determinations of anticipated levels of formaldehyde release, the employer may rely on objective data indicating the extent of potential formaldehyde release under reasonably foreseeable conditions of use.

(v) "Substitute warning labels." The employer may use warning labels required by other statutes, regulations, or ordinances which impart the same information as the warning statements required by this paragraph.

(4) "Material safety data sheets." (i) Any employer who uses formaldehyde-containing materials listed in paragraph (m)(1)(i) shall comply with the requirements of 29 CFR 1915.1200(g) with regard to the development and updating of material safety data sheets.

(ii) Manufacturers, importers, and distributors of formaldehyde-containing materials listed in paragraph (m)(1)(i) shall assure that material safety data sheets and updated information are provided to all employers purchasing such materials at the time of the initial shipment and at the time of the first shipment after a material safety data sheet is updated.

(5) "Written hazard communication program." The employer shall develop, implement, and maintain at the workplace, a written hazard communication program for formaldehyde exposures in the workplace, which at a minimum describes how the requirements specified in this paragraph for labels and other forms of warning and material safety data sheets, and paragraph (n) for employee information and training, will be met. Employers in multi-employer workplaces shall comply with the requirements of 29 CFR 1915.1200(e)(2).

(n) "Employee information and training" - (1) "Participation." The employer shall assure that all employees who are assigned to workplaces where there is exposure to formaldehyde participate in a training program, except that where the employer can show, using objective data, that employees are not exposed to formaldehyde at or above 0.1 ppm, the employer is not required to provide training.

(2) "Frequency." Employers shall provide such information and training to employees at the time of initial assignment, and whenever a new exposure to formaldehyde is introduced into the work area. The training shall be repeated at least annually.

(3) "Training program." The training program shall be conducted in a manner which the employee is able to understand and shall include:

(i) A discussion of the contents of this regulation and the contents of the Material Safety Data Sheet.

(ii) The purpose for and a description of the medical surveillance program required by this standard, including:

(A) A description of the potential health hazards associated with exposure to formaldehyde and a description of the signs and symptoms of exposure to formaldehyde.

(B) Instructions to immediately report to the employer the development of any adverse signs or symptoms that the employee suspects is attributable to formaldehyde exposure.

(iii) Description of operations in the work area where formaldehyde is present and an explanation of the safe work practices appropriate for limiting exposure to formaldehyde in each job;

(iv) The purpose for, proper use of, and limitations of personal protective clothing and equipment;

(v) Instructions for the handling of spills, emergencies, and clean-up procedures;

(vi) An explanation of the importance of engineering and work practice controls for employee protection and any necessary instruction in the use of these controls; and

(vii) A review of emergency procedures including the specific duties or assignments of each employee in the event of an emergency.

(4) "Access to training materials." (i) The employer shall inform all affected employees of the location of written training materials and shall make these materials readily available, without cost, to the affected employees.

(ii) The employer shall provide, upon request, all training materials relating to the employee training program to the Assistant Secretary and the Director.

(o) "Recordkeeping" - (1) "Exposure measurements." The employer shall establish and maintain an accurate record of all measurements taken to monitor employee exposure to formaldehyde. This record shall include:

(i) The date of measurement;

(ii) The operation being monitored;

(iii) The methods of sampling and analysis and evidence of their accuracy and precision;

(iv) The number, durations, time, and results of samples taken;

(v) The types of protective devices worn; and

(vi) The names, job classifications, social security numbers, and exposure estimates of the employees whose exposures are represented by the actual monitoring results.

(2) "Exposure determinations." Where the employer has determined that no monitoring is required under this standard, the employer shall maintain a record of the objective data relied upon to support the determination that no employee is exposed to formaldehyde at or above the action level.

(3) "Medical surveillance." The employer shall establish and maintain an accurate record for each employee subject to medical surveillance under this standard. This record shall include:

(i) The name and social security number of the employee;

(ii) The physician's written opinion;

(iii) A list of any employee health complaints that may be related to exposure to formaldehyde; and

(iv) A copy of the medical examination results, including medical disease questionnaires and results of any medical tests required by the standard or mandated by the examining physician.

(4) "Respirator fit testing." (i) The employer shall establish and maintain accurate records for employees subject to negative pressure respirator fit testing required by this standard.

(ii) This record shall include:

(A) A copy of the protocol selected for respirator fit testing.

(B) A copy of the results of any fit testing performed.

(D) The date of the most recent fit testing, the name and social security number of each tested employee, and the respirator type and facepiece selected.

(5) "Record retention." The employer shall retain records required by this standard for at least the following periods:

(i) Exposure records and determinations shall be kept for at least 30 years.

(ii) Medical records shall be kept for the duration of employment plus 30 years.

(iii) Respirator fit testing records shall be kept until replaced by a more recent record.

(6) "Availability of records." (i) Upon request, the employer shall make all records maintained as a requirement of this standard available for examination and copying to the Assistant Secretary and the Director.

(ii) The employer shall make employee exposure records, including estimates made from representative monitoring and available upon request for examination, and copying to the subject employee, or former employee, and employee representatives in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i).

(iii) Employee medical records required by this standard shall be provided upon request for examination and copying, to the subject employee or former employee or to anyone having the specific written consent of the subject employee or former employee in accordance with 29 CFR 1915.1120(a)-(e) and (g)-(i).

(p) "Dates" - (1) "Effective dates" - (i) "General." This section shall become effective February 2, 1988, except as noted below.

(ii) "Laboratories." This standard shall become effective for anatomy, histology, and pathology laboratories February 2, 1988, except as noted in the start-up date section. For all other laboratories, paragraphs (a) and (c) of this standard shall become effective February 2, 1988, and paragraphs (b) and (d)-(o) of this standard shall become effective on September 1, 1988 except as noted in the start-up date section.

(2) "Start-up dates" - (i) "Exposure determinations." Initial monitoring or objective determinations that no monitoring is required by the standard shall be completed by 6 months after the effective date of the standard.

(ii) "Medical surveillance." The initial medical surveillance of all eligible employees shall be completed by 6 months after the effective date of the standard.

(iii) "Emergencies." The emergency procedures required by this standard shall be implemented by 6 months after the effective date of the standard.

(iv) "Respiratory protection." Respiratory protection as required in this standard shall be provided as soon as possible and no later than 9 months after the effective date of the standard.

(v) "Engineering and work practice controls." Engineering and work practice controls required by this standard shall be implemented as soon as possible, but no later than one year after the effective date of the standard.

(vi) "Employee training." Written materials for employee training shall be updated as soon as possible, but no later than 2 months after the effective date of the standard.

(3) "Start-up dates of amended paragraphs" - (i) "Respiratory protection." Respiratory protection required to meet the amended PEL of 0.75 ppm TWA shall be provided as soon as possible but no later than September 24, 1992.

(ii) "Engineering and work practice controls." Engineering and work practice controls required to meet the amended PEL of 0.75 ppm TWA shall be implemented as soon as possible, but no later than June 26, 1993.

(iii) "Medical removal protection." The medical removal protection provisions including the multiple physician review mechanism shall be implemented no later than December 28, 1992.

(iv) "Hazard communication." The labeling provisions contained in amended paragraph (m) of this standard shall be implemented no later than December 28, 1992. Labeling of containers of formaldehyde products shall continue to comply with the provisions of 29 CFR 1915.1200(e)-(j) until that time.

(v) "Training." The periodic training mandated for all employees exposed to formaldehyde between 0.1 ppm and 0.5 ppm shall begin no later than August 25, 1992

(Approved by the Office of Management and Budget under control number 1218-0145)

[58 FR 35672, July 1, 1993]

1915.1048 Appendix A Substance Technical Guidelines for Formalin.

The following Substance Technical Guideline for Formalin provides information on uninhibited formalin solution (37 percent formaldehyde, no methanol stabilizer). It is designed to inform employees at the production level of their rights and duties under the formaldehyde standard whether their job title defines them as workers or supervisors. Much of the information provided is general; however, some information is specific for formalin. When employee exposure to formaldehyde is from resins capable of releasing formaldehyde, the resin itself and other impurities or decomposition products may also be toxic, and employers should include this information as well when informing employees of the hazards associated with the materials they handle. The precise hazards associated with exposure to formaldehyde depend both on the form (solid, liquid, or gas) of the material and the concentration of formaldehyde present. For example, 37-50 percent solutions of formaldehyde present a much greater hazard to the skin and eyes from spills or splashes than solutions containing less than 1 percent formaldehyde. Individual Substance Technical Guidelines used by the employer for training employees should be modified to properly give information on the material actually being used.

"Substance Identification"

Chemical Name: Formaldehyde Chemical Family: Aldehyde Chemical Formula: HCHO Molecular Weight: 30.03 Chemical Abstracts Service Number (CAS Number): 50-00-0

"Synonyms:" Formalin; Formic Aldehyde; Paraform; Formol; Formalin (Methanol-free); Fyde; Formalith; Methanal; Methyl Aldehyde; Methylene Glycol; Methylene Oxide; Tetraoxymethalene; Oxomethane; Oxymethylene

"Components and Contaminants"

Percent: 37.0 Formaldehyde Percent: 63.0 Water

(Note.-Inhibited solutions contain methanol.)

"Other Contaminants:" Formic acid (alcohol free)

"Exposure Limits:"

OSHA TWA - 1 ppm OSHA STEL - 2 ppm

"Physical Data"

Description: Colorless liquid, pungent odor Boiling point: 214 deg. F (101 deg. C) Specific Gravity: 1.08 (H(2)O=1 at 20 deg. C) pH: 2.8-4.0 Solubility in Water: Miscible Solvent Solubility: Soluble in alcohol and acetone Vapor Density: 1.04 (Air=1 at 20 deg. C) Odor Threshold: 0.8-1 ppm

"Fire and Explosion Hazard"

Moderate fire and explosion hazard when exposed to heat or flame. The flash point of 37 percent formaldehyde solutions is above normal room temperature, but the explosion range is very wide, from 7 to 73 percent by volume in air.

Reaction of formaldehyde with nitrogen dioxide, nitromethane, perchloric acid and aniline, or peroxyformic acid yields explosive compounds.

Flash Point: 185 deg. F (85 deg. C) closed cup Lower Explosion Limit: 7 percent Upper Explosion Limit: 73 percent Autoignition Temperature: 806 deg. F (430 deg. C) Flammability Class (OSHA): III A

"Extinguishing Media:" Use dry chemical, "alcohol foam", carbon dioxide, or water in flooding amounts as fog. Solid streams may not be effective. Cool fire-exposed containers with water from side until well after fire is out.

Use of water spray to flush spills can also dilute the spill to produce nonflammable mixtures. Water runoff, however, should be contained for treatment.

"National Fire Protection Association Section 325M Designation:"

"Health:" 2-Materials hazardous to health, but areas may be entered with full-faced mask self-contained breathing apparatus which provides eye protection.

"Flammability:" 2-Materials which must be moderately heated before ignition will occur. Water spray may be used to extinguish the fire because the material can be cooled below its flash point.

"Reactivity:" D-Materials which (in themselves) are normally stable even under fire exposure conditions and which are not reactive with water. Normal fire fighting procedures may be used.

"Reactivity"

"Stability:" Formaldehyde solutions may self-polymerize to form paraformaldehyde which precipitates.

"Incompatibility (Materials to Avoid):" Strong oxidizing agents, caustics, strong alkalies, isocyanates, anhydrides, oxides, and inorganic acids. Formaldehyde reacts with hydrochloric acid to form the potent carcinogen, bis-chloromethyl ether. Formaldehyde reacts with nitrogen dioxide, nitromethane, perchloric acid and aniline, or peroxyformic acid to yield explosive compounds. A violent reaction occurs when formaldehyde is mixed with strong oxidizers.

Hazardous Combustion or Decomposition Products: Oxygen from the air can oxidize formaldehyde to formic acid, especially when heated. Formic acid is corrosive.

"Health Hazard Data"

Acute Effects of Exposure

"Ingestion (Swallowing):" Liquids containing 10 to 40 percent formaldehyde cause severe irritation and inflammation of the mouth, throat, and stomach. Severe stomach pains will follow ingestion with possible loss of consciousness and death. Ingestion of dilute formaldehyde solutions (0.03-0.04 percent) may cause discomfort in the stomach and pharynx.

"Inhalation (Breathing):" Formaldehyde is highly irritating to the upper respiratory tract and eyes. Concentrations of 0.5 to 2.0 ppm may irritate the eyes, nose, and throat of some individuals. Concentrations of 3 to 5 ppm also cause tearing of the eyes and are intolerable to some persons. Concentrations of 10 to 20 ppm cause difficulty in breathing, burning of the nose and throat, cough, and heavy tearing of the eyes, and 25 to 30 ppm causes severe respiratory tract injury leading to pulmonary edema and pneumonitis. A concentration of 100 ppm is immediately dangerous to life and health. Deaths from accidental exposure to high concentrations of formaldehyde have been reported.

"Skin (Dermal):" Formalin is a severe skin irritant and a sensitizer. Contact with formalin causes white discoloration, smarting, drying, cracking, and scaling. Prolonged and repeated contact can cause numbness and a hardening or tanning of the skin. Previously exposed persons may react to future exposure with an allergic eczematous dermatitis or hives.

"Eye Contact:" Formaldehyde solutions splashed in the eye can cause injuries ranging from transient discomfort to severe, permanent corneal clouding and loss of vision. The severity of the effect depends on the concentration of formaldehyde in the solution and whether or not the eyes are flushed with water immediately after the accident.

Note.-The perception of formaldehyde by odor and eye irritation becomes less sensitive with time as one adapts to formaldehyde. This can lead to overexposure if a worker is relying on formaldehyde's warning properties to alert him or her to the potential for exposure.

Acute Animal Toxicity: Oral, rats: LD50=800 mg/kg Oral, mouse: LD50=42 mg/kg Inhalation, rats: LCLo=250 mg/kg Inhalation, mouse: LCLo=900 mg/kg Inhalation, rats: LC50=590 mg/kg

"Chronic Effects of Exposure"

"Carcinogenicity:" Formaldehyde has the potential to cause cancer in humans. Repeated and prolonged exposure increases the risk. Various animal experiments have conclusively shown formaldehyde to be a carcinogen in rats. In humans, formaldehyde exposure has been associated with cancers of the lung, nasopharynx and oropharynx, and nasal passages.

"Mutagenicity:" Formaldehyde is genotoxic in several "in vitro" test systems showing properties of both an initiator and a promoter.

"Toxicity:" Prolonged or repeated exposure to formaldehyde may result in respiratory impairment. Rats exposed to formaldehyde at 2 ppm developed benign nasal tumors and changes of the cell structure in the nose as well as inflamed mucous membranes of the nose. Structural changes in the epithelial cells in the human nose have also been observed. Some persons have developed asthma or bronchitis following exposure to formaldehyde, most often as the result of an accidental spill involving a single exposure to a high concentration of formaldehyde.

"Emergency and First Aid Procedures"

"Ingestion (Swallowing):" If the victim is conscious, dilute, inactivate, or absorb the ingested formaldehyde by giving milk, activated charcoal, or water. Any organic material will inactivate formaldehyde. Keep affected person warm and at rest. Get medical attention immediately. If vomiting occurs, keep head lower than hips.

"Inhalation (Breathing):" Remove the victim from the exposure area to fresh air immediately. Where the formaldehyde concentration may be very high, each rescuer must put on a self-contained breathing apparatus before attempting to remove the victim, and medical personnel should be informed of the formaldehyde exposure immediately. If breathing has stopped, give artificial respiration. Keep the affected person warm and at rest. Qualified first-aid or medical personnel should administer oxygen, if available, and maintain the patient's airways and blood pressure until the victim can be transported to a medical facility. If exposure results in a highly irritated upper respiratory tract and coughing continues for more than 10 minutes, the worker should be hospitalized for observation and treatment.

"Skin Contact:" Remove contaminated clothing (including shoes) immediately. Wash the affected area of your body with soap or mild detergent and large amounts of water until no evidence of the chemical remains (at least 15 to 20 minutes). If there are chemical burns, get first aid to cover the area with sterile, dry dressing, and bandages. Get medical attention if you experience appreciable eye or respiratory irritation.

"Eye Contact:" Wash the eyes immediately with large amounts of water occasionally lifting lower and upper lids, until no evidence of chemical remains (at least 15 to 20 minutes). In case of burns, apply sterile bandages loosely without medication. Get medical attention immediately. If you have experienced appreciable eye irritation from a splash or excessive exposure, you should be referred promptly to an opthamologist for evaluation.

"Emergency Procedures"

"Emergencies:" If you work in an area where a large amount of formaldehyde could be released in an accident or from equipment failure, your employer must develop procedures to be followed in event of an emergency. You should be trained in your specific duties in the event of an emergency, and it is important that you clearly understand these duties. Emergency equipment must be accessible and you should be trained to use any equipment that you might need. Formaldehyde contaminated equipment must be cleaned before reuse.

If a spill of appreciable quantity occurs, leave the area quickly unless you have specific emergency duties. Do not touch spilled material. Designated persons may stop the leak and shut off ignition sources if these procedures can be done without risk. Designated persons should isolate the hazard area and deny entry except for necessary people protected by suitable protective clothing and respirators adequate for the exposure. Use water spray to reduce vapors. Do not smoke, and prohibit all flames or flares in the hazard area.

"Special Firefighting Procedures:" Learn procedures and responsibilities in the event of a fire in your workplace. Become familiar with the appropriate equipment and supplies and their location. In firefighting, withdraw immediately in case of rising sound from venting safety device or any discoloration of storage tank due to fire.

"Spill, Leak, and Disposal Procedures"

"Occupational Spill:" For small containers, place the leaking container in a well ventilated area. Take up small spills with absorbent material and place the waste into properly labeled containers for later disposal. For larger spills, dike the spill to minimize contamination and facilitate salvage or disposal. You may be able to neutralize the spill with sodium hydroxide or sodium sulfite. Your employer must comply with EPA rules regarding the clean-up of toxic waste and notify state and local authorities, if required. If the spill is greater than 1,000 lb/day, it is reportable under EPA's Superfund legislation.

"Waste Disposal:" Your employer must dispose of waste containing formaldehyde in accordance with applicable local, state, and Federal law and in a manner that minimizes exposure of employees at the site and of the clean-up crew.

"Monitoring and Measurement Procedures"

"Monitoring Requirements:" If your exposure to formaldehyde exceeds the 0.5 ppm action level or the 2 ppm STEL, your employer must monitor your exposure. Your employer need not measure every exposure if a "high exposure" employee can be identified. This person usually spends the greatest amount of time nearest the process equipment. If you are a "representative employee", you will be asked to wear a sampling device to collect formaldehyde. This device may be a passive badge, a sorbent tube attached to a pump, or an impinger containing liquid. You should perform your work as usual, but inform the person who is conducting the monitoring of any difficulties you are having wearing the device.

"Evaluation of 8-hour Exposure:" Measurements taken for the purpose of determining time-weighted average (TWA) exposures are best taken with samples covering the full shift. Samples collected must be taken from the employee's breathing zone air.

"Short-term Exposure Evaluation:" If there are tasks that involve brief but intense exposure to formaldehyde, employee exposure must be measured to assure compliance with the STEL. Sample collections are for brief periods, only 15 minutes, but several samples may be needed to identify the peak exposure.

"Monitoring Techniques:" OSHA's only requirement for selecting a method for sampling and analysis is that the methods used accurately evaluate the concentration of formaldehyde in employees' breathing zones. Sampling and analysis may be performed by collection of formaldehyde on liquid or solid sorbents with subsequent chemical analysis. Sampling and analysis may also be performed by passive diffusion monitors and short-term exposure may be measured by instruments such as real-time continuous monitoring systems and portable direct reading instruments.

"Notification of Results:" Your employer must inform you of the results of exposure monitoring representative of your job. You may be informed in writing, but posting the results where you have ready access to them constitutes compliance with the standard.

"Protective Equipment and Clothing"

[Material impervious to formaldehyde is needed if the employee handles formaldehyde solutions of 1 percent or more. Other employees may also require protective clothing or equipment to prevent dermatitis.] "Respiratory Protection:" Use NIOSH-approved full facepiece negative pressure respirators equipped with approved cartridges or canisters within the use limitations of these devices. (Present restrictions on cartridges and canisters do not permit them to be used for a full workshift.) In all other situations, use positive pressure respirators such as the positive-pressure air purifying respirator or the self-contained breathing apparatus (SCBA). If you use a negative pressure respirator, your employer must provide you with fit testing of the respirator at least once a year in accordance with the procedures outlined in Appendix E.

"Protective Gloves:" Wear protective (impervious) gloves provided by your employer, at no cost, to prevent contact with formalin. Your employer should select these gloves based on the results of permeation testing and in accordance with the ACGIH Guidelines for Selection of Chemical Protective Clothing.

"Eye Protection:" If you might be splashed in the eyes with formalin, it is essential that you wear goggles or some other type of complete protection for the eye. You may also need a face shield if your face is likely to be splashed with formalin, but you must not substitute face shields for eye protection. (This section pertains to formaldehyde solutions of 1 percent or more.) "Other Protective Equipment:" You must wear protective (impervious) clothing and equipment provided by your employer at no cost to prevent repeated or prolonged contact with formaldehyde liquids. If you are required to change into whole-body chemical protective clothing, your employer must provide a change room for your privacy and for storage of your normal clothing.

If you are splashed with formaldehyde, use the emergency showers and eyewash fountains provided by your employer immediately to prevent serious injury. Report the incident to your supervisor and obtain necessary medical support.

"Entry Into an IDLH Atmosphere"

Enter areas where the formaldehyde concentration might be 100 ppm or more only with complete body protection including a self-contained breathing apparatus with a full facepiece operated in a positive pressure mode or a supplied air respirator with full facepiece and operated in a positive pressure mode. This equipment is essential to protect your life and health under such extreme conditions.

"Engineering Controls"

Ventilation is the most widely applied engineering control method for reducing the concentration of airborne substances in the breathing zones of workers. There are two distinct types of ventilation.

"Local Exhaust:" Local exhaust ventilation is designed to capture airborne contaminants as near to the point of generation as possible. To protect you, the direction of contaminant flow must always be toward the local exhaust system inlet and away from you.

"General (Mechanical):" General dilution ventilation involves continuous introduction of fresh air into the workroom to mix with the contaminated air and lower your breathing zone concentration of formaldehyde. Effectiveness depends on the number of air changes per hour. Where devices emitting formaldehyde are spread out over a large area, general dilution ventilation may be the only practical method of control.

"Work Practices:" Work practices and administrative procedures are an important part of a control system. If you are asked to perform a task in a certain manner to limit your exposure to formaldehyde, it is extremely important that you follow these procedures.

"Medical Surveillance"

Medical surveillance helps to protect employees' health. You are encouraged strongly to participate in the medical surveillance program.

Your employer must make a medical surveillance program available at no expense to you and at a reasonable time and place if you are exposed to formaldehyde at concentrations above 0.5 ppm as an 8-hour average or 2 ppm over any 15-minute period. You will be offered medical surveillance at the time of your initial assignment and once a year afterward as long as your exposure is at least 0.5 ppm (TWA) or 2 ppm (STEL). Even if your exposure is below these levels, you should inform your employer if you have signs and symptoms that you suspect, through your training, are related to your formaldehyde exposure because you may need medical surveillance to determine if your health is being impaired by your exposure.

The surveillance plan includes:

(a) A medical disease questionnaire. (b) A physical examination if the physician determines this is necessary.

If you are required to wear a respirator, your employer must offer you a physical examination and a pulmonary function test every year.

The physician must collect all information needed to determine if you are at increased risk from your exposure to formaldehyde. At the physician's discretion, the medical examination may include other tests, such as a chest x-ray, to make this determination.

After a medical examination the physician will provide your employer with a written opinion which includes any special protective measures recommended and any restrictions on your exposure. The physician must inform you of any medical conditions you have which would be aggravated by exposure to formaldehyde.

All records from your medical examinations, including disease surveys, must be retained at your employer's expense.

"Emergencies"

If you are exposed to formaldehyde in an emergency and develop signs or symptoms associated with acute toxicity from formaldehyde exposure, your employer must provide you with a medical examination as soon as possible. This medical examination will include all steps necessary to stabilize your health. You may be kept in the hospital for observation if your symptoms are severe to ensure that any delayed effects are recognized and treated.

[58 FR 35677, July 1, 1993]

1915.1048 Appendix B

Sampling Strategy and Analytical Methods for Formaldehyde.

To protect the health of employees, exposure measurements must be unbiased and representative of employee exposure. The proper measurement of employee exposure requires more than a token commitment on the part of the employer. OSHA's mandatory requirements establish a baseline; under the best of circumstances all questions regarding employee exposure will be answered. Many employers, however, will wish to conduct more extensive monitoring before undertaking expensive commitments, such as engineering controls, to assure that the modifications are truly necessary. The following sampling strategy, which was developed at NIOSH by Nelson A. Leidel, Kenneth A. Busch, and Jeremiah R. Lynch and described in NIOSH publication No. 77-173 (Occupational Exposure Sampling Strategy Manual) will assist the employer in developing a strategy for determining the exposure of his or her employees.

There is no one correct way to determine employee exposure. Obviously, measuring the exposure of every employee exposed to formaldehyde will provide the most information on any given day. Where few employees are exposed, this may be a practical solution. For most employers, however, use of the following strategy will give just as much information at less cost.

Exposure data collected on a single day will not automatically guarantee the employer that his or her workplace is always in compliance with the formaldehyde standard. This does not imply, however, that it is impossible for an employer to be sure that his or her worksite is in compliance with the standard. Indeed, a properly designed sampling strategy showing that all employees are exposed below the PELs, at least with a 95 percent certainty, is compelling evidence that the exposure limits are being achieved provided that measurements are conducted using valid sampling strategy and approved analytical methods.

There are two PELs, the TWA concentration and the STEL. Most employers will find that one of these two limits is more critical in the control of their operations, and OSHA expects that the employer will concentrate monitoring efforts on the critical component. If the more difficult exposure is controlled, this information, along with calculations to support the assumptions, should be adequate to show that the other exposure limit is also being achieved.

"Sampling Strategy"

Determination of the Need for Exposure Measurements

The employer must determine whether employees may be exposed to concentrations in excess of the action level. This determination becomes the first step in an employee exposure monitoring program that minimizes employer sampling burdens while providing adequate employee protection. If employees may be exposed above the action level, the employer must measure exposure. Otherwise, an objective determination that employee exposure is low provides adequate evidence that exposure potential has been examined.

The employer should examine all available relevant information, eg. insurance company and trade association data and information from suppliers or exposure data collected from similar operations. The employer may also use previously-conducted sampling including area monitoring. The employer must make a determination relevant to each operation although this need not be on a separate piece of paper. If the employer can demonstrate conclusively that no employee is exposed above the action level or the STEL through the use of objective data, the employer need proceed no further on employee exposure monitoring until such time that conditions have changed and the determination is no longer valid.

If the employer cannot determine that employee exposure is less than the action level and the STEL, employee exposure monitoring will have to be conducted.

Workplace Material Survey

The primary purpose of a survey of raw material is to determine if formaldehyde is being used in the work environment and if so, the conditions under which formaldehyde is being used.

The first step is to tabulate all situations where formaldehyde is used in a manner such that it may be released into the workplace atmosphere or contaminate the skin. This information should be available through analysis of company records and information on the MSDSs available through provisions of this standard and the Hazard Communication standard.

If there is an indication from materials handling records and accompanying MSDSs that formaldehyde is being used in the following types of processes or work operations, there may be a potential for releasing formaldehyde into the workplace atmosphere:

(1) Any operation that involves grinding, sanding, sawing, cutting, crushing, screening, sieving, or any other manipulation of material that generates formaldehyde-bearing dust (2) Any processes where there have been employee complaints or symptoms indicative of exposure to formaldehyde (3) Any liquid or spray process involving formaldehyde (4) Any process that uses formaldehyde in preserved tissue (5) Any process that involves the heating of a formaldehyde-bearing resin.

Processes and work operations that use formaldehyde in these manners will probably require further investigation at the worksite to determine the extent of employee monitoring that should be conducted.

Workplace Observations

To this point, the only intention has been to provide an indication as to the existence of potentially exposed employees. With this information, a visit to the workplace is needed to observe work operations, to identify potential health hazards, and to determine whether any employees may be exposed to hazardous concentrations of formaldehyde.

In many circumstances, sources of formaldehyde can be identified through the sense of smell. However, this method of detection should be used with caution because of olfactory fatigue.

Employee location in relation to source of formaldehyde is important in determining if an employee may be significantly exposed to formaldehyde. In most instances, the closer a worker is to the source, the higher the probability that a significant exposure will occur.

Other characteristics should be considered. Certain high temperature operations give rise to higher evaporation rates. Locations of open doors and windows provide natural ventilation that tend to dilute formaldehyde emissions. General room ventilation also provides a measure of control.

Calculation of Potential Exposure Concentrations

By knowing the ventilation rate in a workplace and the quantity of formaldehyde generated, the employer may be able to determine by calculation if the PELs might be exceeded. To account for poor mixing of formaldehyde into the entire room, locations of fans and proximity of employees to the work operation, the employer must include a safety factor. If an employee is relatively close to a source, particularly if he or she is located downwind, a safety factor of 100 may be necessary. For other situations, a factor of 10 may be acceptable. If the employer can demonstrate through such calculations that employee exposure does not exceed the action level or the STEL, the employer may use this information as objective data to demonstrate compliance with the standard.

Sampling Strategy

Once the employer determines that there is a possibility of substantial employee exposure to formaldehyde, the employer is obligated to measure employee exposure.

The next step is selection of a maximum risk employee. When there are different processes where employees may be exposed to formaldehyde, a maximum risk employee should be selected for each work operation.

Selection of the maximum risk employee requires professional judgment. The best procedure for selecting the maximum risk employee is to observe employees and select the person closest to the source of formaldehyde. Employee mobility may affect this selection; eg. if the closest employee is mobile in his tasks, he may not be the maximum risk employee. Air movement patterns and differences in work habits will also affect selection of the maximum risk employee.

When many employees perform essentially the same task, a maximum risk employee cannot be selected. In this circumstance, it is necessary to resort to random sampling of the group of workers. The objective is to select a subgroup of adequate size so that there is a high probability that the random sample will contain at least one worker with high exposure if one exists. The number of persons in the group influences the number that need to be sampled to ensure that at least one individual from the highest 10 percent exposure group is contained in the sample. For example, to have 90 percent confidence in the results, if the group size is 10, nine should be sampled; for 50, only 18 need to be sampled.

If measurement shows exposure to formaldehyde at or above the action level or the STEL, the employer needs to identify all other employees who may be exposed at or above the action level or STEL and measure or otherwise accurately characterize the exposure of these employees.

Whether representative monitoring or random sampling are conducted, the purpose remains the same-to determine if the exposure of any employee is above the action level. If the exposure of the most exposed employee is less than the action level and the STEL, regardless of how the employee is identified, then it is reasonable to assume that measurements of exposure of the other employees in that operation would be below the action level and the STEL.

Exposure Measurements

There is no "best" measurement strategy for all situations. Some elements to consider in developing a strategy are:

(1) Availability and cost of sampling equipment (2) Availability and cost of analytic facilities (3) Availability and cost of personnel to take samples (4) Location of employees and work operations (5) Intraday and interday variations in the process (6) Precision and accuracy of sampling and analytic methods, and (7) Number of samples needed. Samples taken for determining compliance with the STEL differ from those that measure the TWA concentration in important ways. STEL samples are best taken in a nonrandom fashion using all available knowledge relating to the area, the individual, and the process to obtain samples during periods of maximum expected concentrations. At least three measurements on a shift are generally needed to spot gross errors or mistakes; however, only the highest value represents the STEL.

If an operation remains constant throughout the workshift, a much greater number of samples would need to be taken over the 32 discrete nonoverlapping periods in an 8-hour workshift to verify compliance with a STEL. If employee exposure is truly uniform throughout the workshift, however, an employer in compliance with the 1 ppm TWA would be in compliance with the 2 ppm STEL, and this determination can probably be made using objective data.

Need to Repeat the Monitoring Strategy

Interday and intraday fluctuations in employee exposure are mostly influenced by the physical processes that generate formaldehyde and the work habits of the employee. Hence, in-plant process variations influence the employer's determination of whether or not additional controls need to be imposed. Measurements that employee exposure is low on a day that is not representative of worst conditions may not provide sufficient information to determine whether or not additional engineering controls should be installed to achieve the PELs.

The person responsible for conducting sampling must be aware of systematic changes which will negate the validity of the sampling results. Systematic changes in formaldehyde exposure concentration for an employee can occur due to:

(1) The employee changing patterns of movement in the workplace (2) Closing of plant doors and windows (3) Changes in ventilation from season to season (4) Decreases in ventilation efficiency or abrupt failure of engineering control equipment (5) Changes in the production process or work habits of the employee.

Any of these changes, if they may result in additional exposure that reaches the next level of action (i.e. 0.5 or 1.0 ppm as an 8-hr average or 2 ppm over 15 minutes) require the employer to perform additional monitoring to reassess employee exposure.

A number of methods are suitable for measuring employee exposure to formaldehyde or for characterizing emissions within the worksite. The preamble to this standard describes some methods that have been widely used or subjected to validation testing. A detailed analytical procedure derived from the OSHA Method 52 for acrolein and formaldehyde is presented below for informational purposes.

Inclusion of OSHA's method in this appendix in no way implies that it is the only acceptable way to measure employee exposure to formaldehyde. Other methods that are free from significant interferences and that can determine formaldehyde at the permissible exposure limits within + or - 25 percent of the "true" value at the 95 percent confidence level are also acceptable. Where applicable, the method should also be capable of measuring formaldehyde at the action level to + or - 35 percent of the "true" value with a 95 percent confidence level. OSHA encourages employers to choose methods that will be best for their individual needs. The employer must exercise caution, however, in choosing an appropriate method since some techniques suffer from interferences that are likely to be present in workplaces of certain industry sectors where formaldehyde is used.

"OSHA's Analytical Laboratory Method"

Method No: 52 Matrix: Air Target Concentration: 1 ppm (1.2 mg/m(3)) Procedures: Air samples are collected by drawing known volumes of air through sampling tubes containing XAD-2 adsorbent which have been coated with 2-(hydroxymethyl) piperidine. The samples are desorbed with toluene and then analyzed by gas chromatography using a nitrogen selective detector.

Recommended Sampling Rate and Air Volumes: 0.1 L/min and 24 L Reliable Quantitation Limit:16 ppb (20 ug/m(3)) Standard Error of Estimate at the Target Concentration: 7.3 percent Status of the Method: A sampling and analytical method that has been subjected to the established evaluation procedures of the Organic Methods Evaluation Branch. Date: March 1985

1. "General Discussion"

1.1 "Background:" The current OSHA method for collecting acrolein vapor recommends the use of activated 13X molecular sieves. The samples must be stored in an ice bath during and after sampling and also they must be analyzed within 48 hours of collection. The current OSHA method for collecting formaldehyde vapor recommends the use of bubblers containing 10 percent methanol in water as the trapping solution.

This work was undertaken to resolve the sample stability problems associated with acrolein and also to eliminate the need to use bubblers to sample formaldehyde. A goal of this work was to develop and/or to evaluate a common sampling and analytical procedure for acrolein and formaldehyde.

NIOSH has developed independent methodologies for acrolein and formaldehyde which recommend the use of reagent-coated adsorbent tubes to collect the aldehydes as stable derivatives. The formaldehyde sampling tubes contain Chromosorb 102 adsorbent coated with N-benzylethanolamine (BEA) which reacts with formaldehyde vapor to form a stable oxazolidine compound. The acrolein sampling tubes contain XAD-2 adsorbent coated with 2-(hydroxymethyl)piperidine (2-HMP) which reacts with acrolein vapor to form a different, stable oxazolidine derivative. Acrolein does not appear to react with BEA to give a suitable reaction product. Therefore, the formaldehyde procedure cannot provide a common method for both aldehydes. However, formaldehyde does react with 2-HMP to form a very suitable reaction product. It is the quantitative reaction of acrolein and formaldehyde with 2-HMP that provides the basis for this evaluation.

This sampling and analytical procedure is very similar to the method recommended by NIOSH for acrolein. Some changes in the NIOSH methodology were necessary to permit the simultaneous determination of both aldehydes and also to accommodate OSHA laboratory equipment and analytical techniques.

1.2 "Limit-defining parameters:" The analyte air concentrations reported in this method are based on the recommended air volume for each analyte collected separately and a desorption volume of 1 mL. The amounts are presented as acrolein and/or formaldehyde, even though the derivatives are the actual species analyzed.

1.2.1 "Detection limits of the analytical procedure:" The detection limit of the analytical procedure was 386 pg per injection for formaldehyde. This was the amount of analyte which gave a peak whose height was about five times the height of the peak given by the residual formaldehyde derivative in a typical blank front section of the recommended sampling tube.

1.2.2 "Detection limits of the overall procedure:" The detection limits of the overall procedure were 482 ng per sample (16 ppb or 20 ug/m(3) for formaldehyde). This was the amount of analyte spiked on the sampling device which allowed recoveries approximately equal to the detection limit of the analytical procedure.

1.2.3 "Reliable quantitation limits:" The reliable quantitation limit was 482 ng per sample (16 ppb or 20 ug/m(3)) for formaldehyde. These were the smallest amounts of analyte which could be quantitated within the limits of a recovery of at least 75 percent and a precision (+ or - 1.96 SD) of + or - 25 percent or better.

____________________

The reliable quantitation limit and detection limits reported in the method are based upon optimization of the instrument for the smallest possible amount of analyte. When the target concentration of an exceptionally higher than these limits, they may not be attainable at the routine operating parameters.

___________________

1.2.4 "Sensitivity:" The sensitivity of the analytical procedure over concentration ranges representing 0.4 to 2 times the target concentration, based on the recommended air volumes, was 7,589 area units per ug/mL for formaldehyde. This value was determined from the slope of the calibration curve. The sensitivity may vary with the particular instrument used in the analysis.

1.2.5 "Recovery:" The recovery of formaldehyde from samples used in an 18-day storage test remained above 92 percent when the samples were stored at ambient temperature. These values were determined from regression lines which were calculated from the storage data. The recovery of the analyte from the collection device must be at least 75 percent following storage.

1.2.6 "Precision (analytical method only):" The pooled coefficient of variation obtained from replicate determinations of analytical standards over the range of 0.4 to 2 times the target concentration was 0.0052 for formaldehyde (Section 4.3).

1.2.7 "Precision (overall procedure):" The precision at the 95 percent confidence level for the ambient temperature storage tests was + or - 14.3 percent for formaldehyde. These values each include an additional + or - 5 percent for sampling error. The overall procedure must provide results at the target concentrations that are + or - 25 percent at the 95 percent confidence level.

1.2.8 "Reproducibility:" Samples collected from controlled test atmospheres and a draft copy of this procedure were given to a chemist unassociated with this evaluation. The formaldehyde samples were analyzed following 15 days storage. The average recovery was 96.3 percent and the standard deviation was 1.7 percent.

1.3 "Advantages:"

1.3.1 The sampling and analytical procedures permit the simultaneous determination of acrolein and formaldehyde.

1.3.2 Samples are stable following storage at ambient temperature for at least 18 days.

1.4 "Disadvantages:" None. 2. "Sampling Procedure"

2.1 "Apparatus:"

2.1.1 Samples are collected by use of a personal sampling pump that can be calibrated to within + or - 5 percent of the recommended 0.1 L/min sampling rate with the sampling tube in line.

2.1.2 Samples are collected with laboratory prepared sampling tubes. The sampling tube is constructed of silane treated glass and is about 8-cm long. The ID is 4 mm and the OD is 6 mm. One end of the tube is tapered so that a glass wool end plug will hold the contents of the tube in place during sampling. The other end of the sampling tube is open to its full 4-mm ID to facilitate packing of the tube. Both ends of the tube are fire-polished for safety. The tube is packed with a 75-mg backup section, located nearest the tapered end and a 150-mg sampling section of pretreated XAD-2 adsorbent which has been coated with 2-HMP. The two sections of coated adsorbent are separated and retained with small plugs of silanized glass wool. Following packing, the sampling tubes are sealed with two 7/32 inch OD plastic end caps. Instructions for the pretreatment and the coating of XAD-2 adsorbent are presented in Section 4 of this method.

2.1.3 Sampling tubes, similar to those recommended in this method, are marketed by Supelco, Inc. These tubes were not available when this work was initiated; therefore, they were not evaluated.

2.2 "Reagents:" None required.

2.3 "Technique:"

2.3.1 Properly label the sampling tube before sampling and then remove the plastic end caps.

2.3.2 Attach the sampling tube to the pump using a section of flexible plastic tubing such that the large, front section of the sampling tube is exposed directly to the atmosphere. Do not place any tubing ahead of the sampling tube. The sampling tube should be attached in the worker's breathing zone in a vertical manner such that it does not impede work performance.

2.3.3 After sampling for the appropriate time, remove the sampling tube from the pump and then seal the tube with plastic end caps.

2.3.4 Include at least one blank for each sampling set. The blank should be handled in the same manner as the samples with the exception that air is not drawn through it.

2.3.5 List any potential interferences on the sample data sheet.

2.4 "Breakthrough:"

2.4.1 Breakthrough was defined as the relative amount of analyte found on a backup sample in relation to the total amount of analyte collected on the sampling train.

2.4.2 For formaldehyde collected from test atmospheres containing 6 times the PEL, the average 5 percent breakthrough air volume was 41 L. The sampling rate was 0.1 L/min and the average mass of formaldehyde collected was 250 ug.

2.5 "Desorption Efficiency:" No desorption efficiency corrections are necessary to compute air sample results because analytical standards are prepared using coated adsorbent. Desorption efficiencies were determined, however, to investigate the recoveries of the analytes from the sampling device. The average recovery over the range of 0.4 to 2 times the target concentration, based on the recommended air volumes, was 96.2 percent for formaldehyde. Desorption efficiencies were essentially constant over the ranges studied.

2.6 "Recommended Air Volume and Sampling Rate:"

2.6.1. The recommended air volume for formaldehyde is 24 L.

2.6.2. The recommended sampling rate is 0.1 L/min.

2.7 "Interferences:"

2.7.1 Any collected substance that is capable of reacting 2-HMP and thereby depleting the derivatizing agent is a potential interference. Chemicals which contain a carbonyl group, such as acetone, may be capable or reacting with 2-HMP.

2.7.2 There are no other known interferences to the sampling method.

2.8 "Safety Precautions:"

2.8.1 Attach the sampling equipment to the worker in such a manner that it well not interfere with work performance or safety.

2.8.2 Follow all safety practices that apply to the work area being sampled.

3. "Analytical Procedure"

3.1 "Apparatus:"

3.1.1 A gas chromatograph (GC), equipped with a nitrogen selective detector. A Hewlett-Packard Model 5840A GC fitted with a nitrogen-phosphorus flame ionization detector (NPD) was used for this evaluation. Injections were performed using a Hewlett-Packard Model 7671A automatic sampler.

3.1.2 A GC column capable of resolving the analytes from any interference. A 6 ft x 1/4 in OD (2mm ID) glass GC column containing 10 percent UCON 50-HB-5100 + 2 percent KOH on 80/100 mesh Chromosorb W-AW was used for the evaluation. Injections were performed on-column.

3.1.3 Vials, glass 2-mL with Teflon-lined caps.

3.1.4 Volumetric flasks, pipets, and syringes for preparing standards, making dilutions, and performing injections.

3.2 "Reagents:"

3.2.1 Toluene and dimethylformamide. Burdick and Jackson solvents were used in this evaluation.

3.2.2 Helium, hydrogen, and air, GC grade.

3.2.3 Formaldehyde, 37 percent, by weight, in water. Aldrich Chemical, ACS Reagent Grade formaldehyde was used in this evaluation.

3.2.4 Amberlite XAD-2 adsorbent coated with 2-(hydroxymethyl-piperidine (2-HMP), 10 percent by weight (Section 4).

3.2.5 Desorbing solution with internal standard. This solution was prepared by adding 20 uL of dimethylformamide to 100 mL of toluene.

3.3 "Standard preparation:"

3.3.1 "Formaldehyde:" Prepare stock standards by diluting known volumes of 37 percent formaldehyde solution with methanol. A procedure to determine the formaldehyde content of these standards is presented in Section 4. A standard containing 7.7 mg/mL formaldehyde was prepared by diluting 1 mL of the 37 percent reagent to 50 mL with methanol.

3.3.2 It is recommended that analytical standards be prepared about 16 hours before the air samples are to be analyzed in order to ensure the complete reaction of the analytes with 2-HMP. However, rate studies have shown the reaction to be greater than 95 percent complete after 4 hours. Therefore, one or two standards can be analyzed after this reduced time if sample results are outside the concentration range of the prepared standards.

3.3.3 Place 150-mg portions of coated XAD-2 adsorbent, from the same lot number as used to collect the air samples, into each of several glass 2-mL vials. Seal each vial with a Teflon-lined cap.

3.3.4 Prepare fresh analytical standards each day by injecting appropriate amounts of the diluted analyte directly onto 150-mg portions of coated adsorbent. It is permissible to inject both acrolein and formaldehyde on the same adsorbent portion. Allow the standards to stand at room temperature. A standard, approximately the target levels, was prepared by injecting 11 uL of the acrolein and 12 uL of the formaldehyde stock standards onto a single coated XAD-2 adsorbent portion.

3.3.5 Prepare a sufficient number of standards to generate the calibration curves. Analytical standard concentrations should bracket sample concentrations. Thus, if samples are not in the concentration range of the prepared standards, additional standards must be prepared to determine detector response.

3.3.7 Desorb the standards in the same manner as the samples following the 16-hour reaction time.

3.4 "Sample preparation:"

3.4.1 Transfer the 150-mg section of the sampling tube to a 2-mL vial. Place the 75-mg section in a separate vial. If the glass wool plugs contain a significant number of adsorbent beads, place them with the appropriate sampling tube section. Discard the glass wool plugs if they do not contain a significant number of adsorbent beads.

3.4.2 Add 1 mL of desorbing solution to each vial.

3.4.3 Seal the vials with Teflon-lined caps and then allow them to desorb for one hour. Shake the vials by hand with vigorous force several times during the desorption time.

3.4.4 Save the used sampling tubes to be cleaned and recycled.

3.5 "Analysis:"

3.5.1 GC "Conditions"

"Column Temperature:" Bi-level temperature program - First level: 100 to 140 deg. C at 4 deg.

C/min following completion of the first level. Second level: 140 to 180 deg. C at 20 deg. C/min following completion of the first level.

Isothermal period: Hold column at 180 deg. C until the recorder pen

returns to baseline (usually about 25 min after injection). Injector temperature: 180 deg. C Helium flow rate: 30 mL/min (detector response will be reduced if nitrogen is substituted for helium carrier gas).

Injection volume: 0.8 uL GC column: Six-ft x 1/4-in OD (2 mm ID) glass GC column containing 10 percent UCON 50-HB-5100+2 percent KOH on 80/100 Chromosorb W-AW. NPD "conditions": Hydrogen flow rate: 3 mL/min Air flow rate: 50 mL/min Detector temperature: 275 deg. C 3.5.2 "Chromatogram:" For an example of a typical chromatogram, see Figure 4.11 in OSHA Method 52.

3.5.3 Use a suitable method, such as electronic integration, to measure detector response.

3.5.4 Use an internal standard method to prepare the calibration curve with several standard solutions of different concentrations. Prepare the calibration curve daily. Program the integrator to report results in ug/mL.

3.5.5 Bracket sample concentrations with standards.

3.6 "Interferences (Analytical)"

3.6.1 Any compound with the same general retention time as the analytes and which also gives a detector response is a potential interference. Possible interferences should be reported to the laboratory with submitted samples by the industrial hygienist.

3.6.2 GC parameters (temperature, column, etc.) may be changed to circumvent interferences.

3.6.3 A useful means of structure designation is GC/MS. It is recommended this procedure be used to confirm samples whenever possible.

3.6.4 The coated adsorbent usually contains a very small amount of residual formaldehyde derivative (Section 4.8).

3.7 "Calculations:"

3.7.1 Results are obtained by use of calibration curves. Calibration curves are prepared by plotting detector response against concentration for each standard. The best line through the data points is determined by curve fitting.

3.7.2 The concentration, in ug/mL, for a particular sample is determined by comparing its detector response to the calibration curve. If either of the analytes is found on the backup section, it is added to the amount found on the front section. Blank corrections should be performed before adding the results together.

3.7.3 The acrolein and/or formaldehyde air concentration can be expressed using the following equation:

mg/m(3)=(A)(B)/C where A=ug/mL from 3.7.2, B=desorption volume, and C=L of air sampled.

No desorption efficiency corrections are required.

3.7.4 The following equation can be used to convert results in mg/m(3) to ppm.

ppm=(mg/m(3))(24.45)/MW where mg/m(3)=result from 3.7.3, 24.45=molar volume of an ideal gas at 760 mm Hg and 25 deg. C, MW=molecular weight (30.0).

4. "Backup Data"

4.1 Backup data on detection limits, reliable quantitation limits, sensitivity and precision of the analytical method, breakthrough, desorption efficiency, storage, reproducibility, and generation of test atmospheres are available in OSHA Method 52, developed by the Organics Methods Evaluation Branch, OSHA Analytical Laboratory, Salt Lake City, Utah.

4.2 "Procedure to Coat XAD-2 Adsorbent with 2-HMP:"

4.2.1 "Apparatus:" Soxhlet extraction apparatus, rotary evaporation apparatus, vacuum dessicator, 1-L vacuum flask, 1-L round-bottomed evaporative flask, 1-L Erlenmeyer flask, 250-mL Buchner funnel with a coarse fritted disc, etc.

4.2.2 "Reagents:"

4.2.2.1 Methanol, isooctane, and toluene.

4.2.2.2 2-(Hydroxymethyl)piperidine.

4.2.2.3 Amberlite XAD-2 non-ionic polymeric adsorbent, 20 to 60 mesh, Aldrich Chemical XAD-2 was used in this evaluation.

4.2.3 "Procedure:" Weigh 125 g of crude XAD-2 adsorbent into a 1-L Erlenmeyer flask. Add about 200 mL of water to the flask and then swirl the mixture to wash the adsorbent. Discard any adsorbent that floats to the top of the water and then filter the mixture using a fritted Buchner funnel. Air dry the adsorbent for 2 minutes. Transfer the adsorbent back to the Erlenmeyer flask and then add about 200 mL of methanol to the flask. Swirl and then filter the mixture as before. Transfer the washed adsorbent back to the Erlenmeyer flask and then add about 200 mL of methanol to the flask. Swirl and then filter the mixture as before. Transfer the washed adsorbent to a 1-L round-bottomed evaporative flask, add 13 g of 2-HMP and then 200 mL of methanol, swirl the mixture and then allow it to stand for one hour. Remove the methanol at about 40 deg. C and reduced pressure using a rotary evaporation apparatus. Transfer the coated adsorbent to a suitable container and store it in a vacuum desiccator at room temperature overnight. Transfer the coated adsorbent to a Soxhlet extractor and then extract the material with toluene for about 24 hours. Discard the contaminated toluene, add methanol in its place and then continue the Soxhlet extraction for an additional 4 hours. Transfer the adsorbent to a weighted 1-L round-bottom evaporative flask and remove the methanol using the rotary evaporation apparatus. Determine the weight of the adsorbent and then add an amount of 2-HMP, which is 10 percent by weight of the adsorbent. Add 200 mL of methanol and then swirl the mixture. Allow the mixture to stand for one hour. Remove the methanol by rotary evaporation. Transfer the coated adsorbent to a suitable container and store it in a vacuum desiccator until all traces of solvents are gone. Typically, this will take 2-3 days. The coated adsorbent should be protected from contamination. XAD-2 adsorbent treated in this manner will probably not contain residual acrolein derivative. However, this adsorbent will often contain residual formaldehyde derivative levels of about 0.1 ug per 150 mg of adsorbent. If the blank values for a batch of coated adsorbent are too high, then the batch should be returned to the Soxhlet extractor, extracted with toluene again and then recoated. This process can be repeated until the desired blank levels are attained.

The coated adsorbent is now ready to be packed into sampling tubes. The sampling tubes should be stored in a sealed container to prevent contamination. Sampling tubes should be stored in the dark at room temperature. The sampling tubes should be segregated by coated adsorbent lot number. A sufficient amount of each lot number of coated adsorbent should be retained to prepare analytical standards for use with air samples from that lot number.

4.3 "A Procedure to Determine Formaldehyde by Acid Titration:"

Standardize the 0.1 N HCl solution using sodium carbonate and methyl orange indicator.

Place 50 mL of 0.1 M sodium sulfite and three drops of thymophthalein indicator into a 250-mL Erlenmeyer flask. Titrate the contents of the flask to a colorless endpoint with 0.1 N HCl (usually one or two drops is sufficient). Transfer 10 mL of the formaldehyde/methanol solution (prepared in 3.3.1) into the same flask and titrate the mixture with 0.1 N HCl, again, to a colorless endpoint. The formaldehyde concentration of the standard may be calculated by the following equation:

Formaldehyde, mg/mL

acid titer X acid normality X 30.0
____________________________________
mL of sample

This method is based on the quantitative liberation of sodium hydroxide when formaldehyde reacts with sodium sulfite to form the formaldehyde-bisulfite addition product. The volume of sample may be varied depending on the formaldehyde content but the solution to be titrated must contain excess sodium sulfite. Formaldehyde solutions containing substantial amounts of acid or base must be neutralized before analysis.

[58 FR 35680, July 1, 1993]

1915.1048 Appendix C Medical surveillance - Formaldehyde.

I. "Health Hazards"

The occupational health hazards of formaldehyde are primarily due to its toxic effects after inhalation, after direct contact with the skin or eyes by formaldehyde in liquid or vapor form, and after ingestion.

II. "Toxicology"

A. Acute Effects of Exposure

1. "Inhalation (breathing):" Formaldehyde is highly irritating to the upper airways. The concentration of formaldehyde that is immediately dangerous to life and health is 100 ppm. Concentrations above 50 ppm can cause severe pulmonary reactions within minutes. These include pulmonary edema, pneumonia, and bronchial irritation which can result in death. Concentrations above 5 ppm readily cause lower airway irritation characterized by cough, chest tightness and wheezing. There is some controversy regarding whether formaldehyde gas is a pulmonary sensitizer which can cause occupational asthma in a previously normal individual. Formaldehyde can produce symptoms of bronchial asthma in humans. The mechanism may be either sensitization of the individual by exposure to formaldehyde or direct irritation by formaldehyde in persons with pre-existing asthma. Upper airway irritation is the most common respiratory effect reported by workers and can occur over a wide range of concentrations, most frequently above 1 ppm. However, airway irritation has occurred in some workers with exposures to formaldehyde as low as 0.1 ppm. Symptoms of upper airway irritation include dry or sore throat, itching and burning sensations of the nose, and nasal congestion. Tolerance to this level of exposure may develop within 1-2 hours. This tolerance can permit workers remaining in an environment of gradually increasing formaldehyde concentrations to be unaware of their increasingly hazardous exposure.

2. "Eye contact:" Concentrations of formaldehyde between 0.05 ppm and 0.5 ppm produce a sensation of irritation in the eyes with burning, itching, redness, and tearing. Increased rate of blinking and eye closure generally protects the eye from damage at these low levels, but these protective mechanisms may interfere with some workers' work abilities. Tolerance can occur in workers continuously exposed to concentrations of formaldehyde in this range. Accidental splash injuries of human eyes to aqueous solutions of formaldehyde (formalin) have resulted in a wide range of ocular injuries including corneal opacities and blindness. The severity of the reactions have been directly dependent on the concentration of formaldehyde in solution and the amount of time lapsed before emergency and medical intervention.

3. "Skin contact:" Exposure to formaldehyde solutions can cause irritation of the skin and allergic contact dermatitis. These skin diseases and disorders can occur at levels well below those encountered by many formaldehyde workers. Symptoms include erythema, edema, and vesiculation or hives. Exposure to liquid formalin or formaldehyde vapor can provoke skin reactions in sensitized individuals even when airborne concentrations of formaldehyde are well below 1 ppm.

4. "Ingestion:" Ingestion of as little as 30 ml of a 37 percent solution of formaldehyde (formalin) can result in death. Gastrointestinal toxicity after ingestion is most severe in the stomach and results in symptoms which can include nausea, vomiting, and severe abdominal pain. Diverse damage to other organ systems including the liver, kidney, spleen, pancreas, brain, and central nervous systems can occur from the acute response to ingestion of formaldehyde.

B. Chronic Effects of Exposure

Long term exposure to formaldehyde has been shown to be associated with an increased risk of cancer of the nose and accessory sinuses, nasopharyngeal and oropharyngeal cancer, and lung cancer in humans. Animal experiments provide conclusive evidence of a causal relationship between nasal cancer in rats and formaldehyde exposure. Concordant evidence of carcinogenicity includes DNA binding, genotoxicity in short-term tests, and cytotoxic changes in the cells of the target organ suggesting both preneoplastic changes and a dose-rate effect. Formaldehyde is a complete carcinogen and appears to exert an effect on at least two stages of the carcinogenic process.

III. "Surveillance considerations"

A. History

1. "Medical and occupational history:" Along with its acute irritative effects, formaldehyde can cause allergic sensitization and cancer. One of the goals of the work history should be to elicit information on any prior or additional exposure to formaldehyde in either the occupational or the non-occupational setting.

2. "Respiratory history:" As noted above, formaldehyde has recognized properties as an airway irritant and has been reported by some authors as a cause of occupational asthma. In addition, formaldehyde has been associated with cancer of the entire respiratory system of humans. For these reasons, it is appropriate to include a comprehensive review of the respiratory system in the medical history. Components of this history might include questions regarding dyspnea on exertion, shortness of breath, chronic airway complaints, hyperreactive airway disease, rhinitis, bronchitis, bronchiolitis, asthma, emphysema, respiratory allergic reaction, or other preexisting pulmonary disease.

In addition, generalized airway hypersensitivity can result from exposures to a single sensitizing agent. The examiner should, therefore, elicit any prior history of exposure to pulmonary irritants, and any short- or long-term effects of that exposure.

Smoking is known to decrease mucociliary clearance of materials deposited during respiration in the nose and upper airways. This may increase a worker's exposure to inhaled materials such as formaldehyde vapor. In addition, smoking is a potential confounding factor in the investigation of any chronic respiratory disease, including cancer. For these reasons, a complete smoking history should be obtained.

3. "Skin Disorders:" Because of the dermal irritant and sensitizing effects of formaldehyde, a history of skin disorders should be obtained. Such a history might include the existence of skin irritation, previously documented skin sensitivity, and other dermatologic disorders. Previous exposure to formaldehyde and other dermal sensitizers should be recorded.

4. "History of atopic or allergic diseases:" Since formaldehyde can cause allergic sensitization of the skin and airways, it might be useful to identify individuals with prior allergen sensitization. A history of atopic disease and allergies to formaldehyde or any other substances should also be obtained. It is not definitely known at this time whether atopic diseases and allergies to formaldehyde or any other substances should also be obtained. Also it is not definitely known at this time whether atopic individuals have a greater propensity to develop formaldehyde sensitivity than the general population, but identification of these individuals may be useful for ongoing surveillance.

5. "Use of disease questionnaires:" Comparison of the results from previous years with present results provides the best method for detecting a general deterioration in health when toxic signs and symptoms are measured subjectively. In this way recall bias does not affect the results of the analysis. Consequently, OSHA has determined that the findings of the medical and work histories should be kept in a standardized form for comparison of the year-to-year results.

B. Physical Examination

1. "Mucosa of eyes and airways:" Because of the irritant effects of formaldehyde, the examining physician should be alert to evidence of this irritation. A speculum examination of the nasal mucosa may be helpful in assessing possible irritation and cytotoxic changes, as may be indirect inspection of the posterior pharynx by mirror.

2. "Pulmonary system:" A conventional respiratory examination, including inspection of the thorax and auscultation and percussion of the lung fields should be performed as part of the periodic medical examination. Although routine pulmonary function testing is only required by the standard once every year for persons who are exposed over the TWA concentration limit, these tests have an obvious value in investigating possible respiratory dysfunction and should be used wherever deemed appropriate by the physician. In cases of alleged formaldehyde-induced airway disease, other possible causes of pulmonary disfunction (including exposures to other substances) should be ruled out. A chest radiograph may be useful in these circumstances. In cases of suspected airway hypersensitivity or allergy, it may be appropriate to use bronchial challenge testing with formaldehyde or methacholine to determine the nature of the disorder. Such testing should be performed by or under the supervision of a physician experienced in the procedures involved.

3. "Skin:" The physician should be alert to evidence of dermal irritation of sensitization, including reddening and inflammation, urticaria, blistering, scaling, formation of skin fissures, or other symptoms. Since the integrity of the skin barrier is compromised by other dermal diseases, the presence of such disease should be noted. Skin sensitivity testing carries with it some risk of inducing sensitivity, and therefore, skin testing for formaldehyde sensitivity should not be used as a routine screening test. Sensitivity testing may be indicated in the investigation of a suspected existing sensitivity. Guidelines for such testing have been prepared by the North American Contact Dermatitis Group.

C. Additional Examinations or Tests

The physician may deem it necessary to perform other medical examinations or tests as indicated. The standard provides a mechanism whereby these additional investigations are covered under the standard for occupational exposure to formaldehyde.

D. Emergencies

The examination of workers exposed in an emergency should be directed at the organ systems most likely to be affected. Much of the content of the examination will be similar to the periodic examination unless the patient has received a severe acute exposure requiring immediate attention to prevent serious consequences. If a severe overexposure requiring medical intervention or hospitalization has occurred, the physician must be alert to the possibility of delayed symptoms. Followup nonroutine examinations may be necessary to assure the patient's well-being.

E. Employer Obligations

The employer is required to provide the physician with the following information: A copy of this standard and appendices A, C, D, and E; a description of the affected employee's duties as they relate to his or her exposure concentration; an estimate of the employee's exposure including duration (e.g. 15 hr/wk, three 8-hour shifts, full-time); a description of any personal protective equipment, including respirators, used by the employee; and the results of any previous medical determinations for the affected employee related to formaldehyde exposure to the extent that this information is within the employer's control.

F. Physician's Obligations

The standard requires the employer to obtain a written statement from the physician. This statement must contain the physician's opinion as to whether the employee has any medical condition which would place him or her at increased risk of impaired health from exposure to formaldehyde or use of respirators, as appropriate. The physician must also state his opinion regarding any restrictions that should be placed on the employee's exposure to formaldehyde or upon the use of protective clothing or equipment such as respirators. If the employee wears a respirator as a result of his or her exposure to formaldehyde, the physician's opinion must also contain a statement regarding the suitability of the employee to wear the type of respirator assigned. Finally, the physician must inform the employer that the employee has been told the results of the medical examination and of any medical conditions which require further explanation or treatment. This written opinion is not to contain any information on specific findings or diagnoses unrelated to occupational exposure to formaldehyde.

The purpose in requiring the examining physician to supply the employer with a written opinion is to provide the employer with a medical basis to assist the employer in placing employees initially, in assuring that their health is not being impaired by formaldehyde, and to assess the employee's ability to use any required protective equipment.

[58 FR 35684, July 1, 1993]

1915.1048 Appendix D Nonmandatory Medical Disease Questionnaire.

A. "Identification"

Plant Name____________________________________________________________
Date__________________________________________________________________
Employee Name_________________________________________________________
S.S. #________________________________________________________________
Job Title_____________________________________________________________
Birthdate:____________________________________________________________
Age:__________________________________________________________________
Sex:__________________________________________________________________
Height:_______________________________________________________________
Weight:_______________________________________________________________

B. "Medical History"

1. Have you ever been in the hospital as a patient?
Yes__ No__
If yes, what kind of problem were you having?___________________________
________________________________________________________________________
2. Have you ever had any kind of operation?
Yes__ No__
If yes, what kind?______________________________________________________
________________________________________________________________________
3. Do you take any kind of medicine regularly?
Yes__ No__
If yes, what kind?______________________________________________________
________________________________________________________________________
4. Are you allergic to any drugs, foods, or chemicals?
Yes__ No__
If yes, what kind of allergy is it?_____________________________________
________________________________________________________________________
What causes the allergy?________________________________________________
________________________________________________________________________
5. Have you ever been told that you have asthma, hayfever, or sinusitis?
Yes__ No__
6. Have you ever been told that you have emphysema, bronchitis, or any
other respiratory problems?
Yes__ No__
7. Have you ever been told you had hepatitis?
Yes__ No__
8. Have you ever been told that you had cirrhosis?
Yes__ No__
9. Have you ever been told that you had cancer?
Yes__ No__
10. Have you ever had arthritis or joint pain?
Yes__ No__
11. Have you ever been told that you had high blood pressure?
Yes__ No__
12. Have you ever had a heart attack or heart trouble?
Yes__ No__

B-1. "Medical History Update"

1. Have you been in the hospital as a patient any time within the past
year?
Yes__ No__
If so, for what condition?______________________________________________
________________________________________________________________________
2. Have you been under the care of a physician during the past year?
Yes__ No__
If so, for what condition?______________________________________________
________________________________________________________________________
3. Is there any change in your breathing since last year?
Yes__ No__
Better?_________________________________________________________________
Worse?__________________________________________________________________
No change?______________________________________________________________
If change, do you know why?_____________________________________________
________________________________________________________________________
4. Is your general health different this year from last year?
Yes__ No__
If different, in what way?______________________________________________
________________________________________________________________________
5. Have you in the past year or are you now taking any medication on a
regular basis?
Yes__ No__
Name Rx_________________________________________________________________
Condition being treated ________________________________________________

C. "Occupational History"

1. How long have you worked for your present employer?
________________________________________________________________________
2. What jobs have you held with this employer? Include job title and
length of time in each job.
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
3. In each of these jobs, how many hours a day were you exposed to
chemicals?
________________________________________________________________________
4. What chemicals have you worked with most of the time?
________________________________________________________________________
5. Have you ever noticed any type of skin rash you feel was related to
your work?
Yes__ No__
6. Have you ever noticed that any kind of chemical makes you cough?
Yes__ No__
Wheeze?
Yes__ No__
Become short of breath or cause your chest to become tight?
Yes__ No__
7. Are you exposed to any dust or chemicals at home?
Yes__ No__
If yes, explain:________________________________________________________
________________________________________________________________________
8. In other jobs, have you ever had exposure to:
Wood dust?
Yes__ No__
Nickel of chromium?
Yes__ No__
Silica (foundry, sand blasting)?
Yes__ No__
Arsenic or asbestos?
Yes__ No__
Organic solvents?
Yes__ No__
Urethane foams?
Yes__ No__

C-1. "Occupational History Update"

1. Are you working on the same job this year as you were last year?
Yes__ No__
If not, how has your job changed?_______________________________________
________________________________________________________________________
2. What chemicals are you exposed to on your job?
________________________________________________________________________
3. How many hours a day are you exposed to chemicals?
________________________________________________________________________
4. Have you noticed any skin rash within the past year you feel was
related to your work?
Yes__ No__
If so, explain circumstances:___________________________________________
________________________________________________________________________
5. Have you noticed that any chemical makes you cough, be short of
breath, or wheeze?
Yes__ No__
If so, can you identify it?_____________________________________________
________________________________________________________________________

D. "Miscellaneous"

1. Do you smoke?
Yes__ No__
If so, how much and for how long?_______________________________________
________________________________________________________________________
Pipe____________________________________________________________________
Cigars__________________________________________________________________
Cigarettes______________________________________________________________
2. Do you drink alcohol in any form?
Yes__ No__
If so, how much, how long, and how often?_______________________________
________________________________________________________________________
3. Do you wear glasses or contact lenses?
Yes__ No__
4. Do you get any physical exercise other than that required to do your
job?
Yes__ No__
If so, explain:_________________________________________________________
________________________________________________________________________
5. Do you have any hobbies or "side jobs" that require you to use
chemicals, such as furniture stripping, sand blasting, insulation or
manufacture of urethane foam, furniture, etc?
Yes__ No__
If so, please describe, giving type of business or hobby, chemicals
used and length of exposures.
________________________________________________________________________

E. "Symptoms Questionnaire"

1. Do you ever have any shortness of breath?
Yes__ No__
If yes, do you have to rest after climbing several flights of stairs?
Yes__ No__
If yes, if you walk on the level with people your own age, do you walk
slower than they do?
Yes__ No__
If yes, if you walk slower than a normal pace, do you have to limit the
distance that you walk?
Yes__ No__
If yes, do you have to stop and rest while bathing or dressing?
Yes__ No__
2. Do you cough as much as three months out of the year?
Yes__ No__
If yes, have you had this cough for more than two years?
Yes__ No__
If yes, do you ever cough anything up from chest?
Yes__ No__
3. Do you ever have a feeling of smothering, unable to take a deep
breath, or tightness in your chest?
Yes__ No__
If yes, do you notice that this on any particular day of the week?
Yes__ No__
If yes, what day or the week?
Yes__ No__
If yes, do you notice that this occurs at any particular place?
Yes__ No__
If yes, do you notice that this is worse after you have returned to
work after being off for several days?
Yes__ No__
4. Have you ever noticed any wheezing in your chest?
Yes__ No__
If yes, is this only with colds or other infections?
Yes__ No__
Is this caused by exposure to any kind of dust or other material?
Yes__ No__
If yes, what kind?_____________________________________________________
5. Have you noticed any burning, tearing, or redness of your eyes when
you are at work?
Yes__ No__
If so, explain circumstances:___________________________________________
________________________________________________________________________
6. Have you noticed any sore or burning throat or itchy or burning nose
when you are at work?
Yes__ No__
If so, explain circumstances:___________________________________________
________________________________________________________________________
7. Have you noticed any stuffiness or dryness of your nose?
Yes__ No__
8. Do you ever have swelling of the eyelids or face?
Yes__ No__
9. Have you ever been jaundiced?
Yes__ No__
If yes, was this accompanied by any pain?
Yes__ No__
10. Have you ever had a tendency to bruise easily or bleed excessively?
Yes__ No__
11. Do you have frequent headaches that are not relieved by aspirin or
tylenol?
Yes__ No__
If yes, do they occur at any particular time of the day or week?
Yes__ No__
If yes, when do they occur?_____________________________________________
________________________________________________________________________
12. Do you have frequent episodes of nervousness or irritability?
Yes__ No__
13. Do you tend to have trouble concentrating or remembering?
Yes__ No__
14. Do you ever feel dizzy, light-headed, excessively drowsy or like you
have been drugged?
Yes__ No__
15. Does your vision ever become blurred?
Yes__ No__
16. Do you have numbness or tingling of the hands or feet or other parts
of your body?
Yes__ No__
17. Have you ever had chronic weakness or fatigue?
Yes__ No__
18. Have you ever had any swelling of your feet or ankles to the point
where you could not wear your shoes?
Yes__ No__
19. Are you bothered by heartburn or indigestion?
Yes__ No__
20. Do you ever have itching, dryness, or peeling and scaling of the
hands?
Yes__ No__
21. Do you ever have a burning sensation in the hands, or reddening of
the skin?
Yes__ No__
22. Do you ever have cracking or bleeding of the skin on your hands?
Yes__ No__
23. Are you under a physician's care?
Yes__ No__
If yes, for what are you being treated?_________________________________
________________________________________________________________________
24. Do you have any physical complaints today?
Yes__ No__
If yes, explain?________________________________________________________
________________________________________________________________________
25. Do you have other health conditions not covered by these questions?
Yes__ No__
If yes, explain:________________________________________________________
________________________________________________________________________

[58 FR 35685, July 1, 1993]

1915.1048 App E Qualitative and Quantitative Fit Testing Procedures.

I. "FIT Test Protocols"

Because exposure to formaldehyde can affect the employee's ability to detect common odorants, fit test results from the isoamyl acetate test must be augmented by results from either the saccharin or irritant smoke test.

A. The employer shall include the following provisions in the fit test procedures. These provisions apply to both qualitative fit testing (QLFT) and quantitative fit testing (QNFT).

4. The test subject shall be instructed to hold each facepiece up to the face and eliminate those which obviously do not give a comfortable fit.

6. Assessment of comfort shall include reviewing the following points with the test subject and allowing the test subject adequate time to determine the comfort of the respirator:

(a) position of the mask on the nose. (b) room for eye protection. (c) room to talk. (d) position of mask on face and cheeks.

7. The following criteria shall be used to help determine the adequacy of the respirator fit:

(a) chin properly placed;

(b) adequate strap tension, not overly tightened;

(d) respirator of proper size to span distance from nose to chin;

(e) tendency of respirator to slip;

(f) self-observation in mirror to evaluate fit and respirator position.

(a) "Positive pressure test." Close off the exhalation valve and exhale gently onto the facepiece. The face fit is considered satisfactory if a slight positive pressure can be built up inside the facepiece without any evidence of outward leakage of air at the seal. For most respirators this method of leak testing requires the wearer to first remove the exhalation valve cover before closing off the exhalation valve and then carefully replacing it after the test.

12. The employer shall certify that a successful fit test has been administered to the employee. The certification shall include the following information:

(a) Name of employee;

(b) Type, brand and size of respirator; and

Where QNFT is used, the fit factor, strip chart, or other recording of the results of the test, shall be retained with the certification. The certification shall be maintained until the next fit test is administered.

13. Exercise regimen. Prior to the commencement of the fit test, the test subject shall be given a description of the fit test and the test subject's responsibilities during the test procedure.

The description of the process shall include a description of the test exercises that the subject will be performing. The respirator to be tested shall be worn for at least 5 minutes before the start of the fit test.

14. Test Exercises. The test subject shall perform exercises, in the test environment, in the manner described below:

(a) "Normal breathing." In a normal standing position, without talking, the subject shall breathe normally.

(b) "Deep breathing." In a normal standing position, the subject shall breathe slowly and deeply, taking caution so as to not hyperventilate.

(c) "Turning head side to side." Standing in place, the subject shall slowly turn his/her head from side to side between the extreme positions on each side. The head shall be held at each extreme momentarily so the subject can inhale at each side.

(d) "Moving head up and down." Standing in place, the subject shall slowly move his/her head up and down. The subject shall be instructed to inhale in the up position (i.e., when looking toward the ceiling).

(e) "Talking." The subject shall talk out loud slowly and loud enough so as to be heard clearly by the test conductor. The subject can read from a prepared text such as the Rainbow Passage, count backward from 100, or recite a memorized poem or song.

(f) "Grimace." The test subject shall grimace by smiling or frowning.

(g) "Bending over." The test subject shall bend at the waist as if he/she were to touch his/her toes. Jogging in place shall be substituted for this exercise in those test environments such as shroud type QNFT units which prohibit bending at the waist.

(h) "Normal breathing." Same as exercise 1. Each test exercise shall be performed for one minute except for the grimace exercise which shall be performed for 15 seconds.

B. "Qualitative Fit Test (QLFT) Protocols"

1. "General." (a) The employer shall assign specific individuals who shall assume full responsibility for implementing the respirator qualitative fit test program.

(c) The employer shall assure the QLFT equipment is kept clean and well maintained so as to operate at the parameters for which it was designed.

2. "Isoamyl Acetate Protocol" - (a) "Odor threshold screening." The odor threshold screening test, performed without wearing a respirator, is intended to determine if the individual tested can detect the odor of isoamyl acetate.

(1) Three 1-liter glass jars with metal lids are required.

(2) Odor free water (e.g., distilled or spring water) at approximately 25 degrees C shall be used for the solutions.

(3) The isoamyl acetate (IAA) (also known at isopentyl acetate) stock solution is prepared by adding 1 cc of pure IAA to 800 cc of odor free water in a 1 liter jar and shaking for 30 seconds. A new solution shall be prepared at least weekly.

(5) The odor test solution is prepared in a second jar by placing 0.4 cc of the stock solution into 500 cc of odor free water using a clear dropper or pipette. The solution shall be shaken for 30 seconds and allowed to stand for two to three minutes so that the IAA concentration above the liquid may reach equilibrium. This solution shall be used for only one day.

(6) A test blank shall be prepared in a third jar by adding 500 cc of odor free water.

(8) The following instruction shall be typed on a card and placed on the table in front of the two jars (i.e., 1 and 2): "The purpose of this test is to determine if you can smell banana oil at a low concentration. The two bottles in front of you contain water. One of these bottles also contains a small amount of banana oil. Be sure the covers are on tight, then shake each bottle for two seconds. Unscrew the lid of each bottle, one at a time, and sniff at the mouth of the bottle. Indicate to the test conductor which bottle contains banana oil."

(9) The mixtures used in the IAA odor detection test shall be prepared in an area separate from where the test is performed, in order to prevent olfactory fatigue in the subject.

(10) If the test subject is unable to correctly identify the jar containing the odor test solution, the IAA qualitative fit test shall not be performed.

(11) If the test subject correctly identifies the jar containing the odor test solution, the test subject may proceed to respirator selection and fit testing.

(b) "Isoamyl acetate fit test." (1) The fit test chamber shall be similar to a clear 55-gallon drum liner suspended inverted over a 2-foot diameter frame so that the top of the chamber is about 6 inches above the test subject's head. The inside top center of the chamber shall have a small hook attached.

(3) After selecting, donning, and properly adjusting a respirator, the test subject shall ware it to the fit testing room. This room shall be separate from the room used for odor threshold screening and respirator selection, and shall be well ventilated, as by an exhaust fan or lab hood, to prevent general room contamination.

(4) A copy of the test exercises and any prepared text from which the subject is to read shall be taped to the inside of the test chamber.

(5) Upon entering the test chamber, the test subject shall be given a 6-inch by 5-inch piece of paper towel, or other porous, absorbent, single-ply material, folded in half and wetted with 0.75 cc of pure IAA. The test subject shall hang the wet towel on the hook at the top of the chamber.

(9) When a respirator is found that passes the test, its efficiency shall be demonstrated for the subject by having the subject break the face seal and take a breath before exiting the chamber.

3. "Saccharin Solution Aerosol Protocol." The saccharin solution aerosol QLFT protocol is the only currently available, validated test protocol for use with particulate disposable dust respirators not equipped with high-efficiency filters. The entire screening and testing procedure shall be explained to the test subject prior to the conduct of the screening test.

(a) "Taste threshold screening." The saccharin taste threshold screening, performed without wearing a respirator, is intended to determine whether the individual being tested can detect the taste of saccharin.

(1) Threshold screening as well as fit testing subjects shall wear an enclosure about the head and shoulders that is approximately 12 inches in diameter by 14 inches tall with at least the front portion clear and that allows free movements of the head when a respirator is worn. An enclosure substantially similar to the 3M hood assembly, parts # FT 14 and # FT 15 combined, is adequate.

(2) The test enclosure shall have a 3/4 -inch hole in front of the test subject's nose and mouth area to accommodate the nebulizer nozzle.