September 8, 1987

MEMORANDUM FOR:   REGIONAL ADMINISTRATORS

THRU:             LEO CAREY, DIRECTOR 
                 OFFICE OF FIELD COORDINATION

FROM:             THOMAS SHEPICH, DIRECTOR 
                 DIRECTORATE OF COMPLIANCE PROGRAMS

SUBJECT:          Interim Enforcement Procedures for AIDS, Hepatitis B and
                 Other Blood-borne Infectious Diseases

In the very near future an OSHA Instruction will be issued incorporating procedures and guidelines for CSHO's to follow when conducting inspections at health care facilities where potential exposure to AIDS, Hepatitis B and other blood-borne infectious-diseases exist.

Due to heightened public awareness, some regions have already and others will begin to experience an increase in employee complaints regarding blood-borne infectious diseases. When responding to complaints the following standards shall be considered for protecting health care workers from potential exposure to blood-borne diseases:

29 CFR 1910.132--Personal Protective Equipment

29 CFR 1910.22(a)(1)--General requirements, Housekeeping

29 CFR 1910.141(a)(4)(ii)--Sanitation, Waste disposal

29 CFR 1910.145--Specifications for Accident Prevention Signs and Tags

Section 5(a)(1)--General Duty Clause

Attached for your information, is a copy of the July 16 memo to George Salem (Solicitor of Labor) from Cynthia Attwood (Associate Solicitor). This memo provides legal opinion on the use of existing OSHA standards and the General Duty Clause in protecting workers from blood-borne infectious diseases.

All cases involving potential exposure to AIDS, Hepatitis B, or other blood-borne infectious diseases must be coordinated with Jacqueline Rogers of the Office of Health Compliance Assistance on FTS-523-8036. If you have any questions concerning this issue, please contact Ms. Rogers.

Attachment



July 16, 1987

MEMORANDUM FOR:     GEORGE R. SALEM
                   Solicitor of Labor

FROM:               CYNTHIA L. ATTWOOD 
                   Associate Solicitor for 
                   Occupational Safety and Health

SUBJECT:            Use of General Standards and the General Duty Clause in
                   Protecting Healthcare Workers from Bloodborne Diseases.

I. Introduction

The purpose of this memorandum is to explore the possibilities of enforcing 29 CFR 1910.132(a) (the general personal protective equipment standard), 29 CFR 1910.22(a)(1) (the general housekeeping standard), 29 CFR 1910.141(a)(4)(ii) (a waste disposal standard), and section 5(a)(1) of the OSHA Act (the general duty clause) to protect healthcare workers from bloodborne diseases -- in particular, hepatitis B and acquired immunodeficiency syndrome (AIDS). The principal focus of concern is the protection of healthcare workers in hospitals. According to figures from the Bureau of Labor Statistics, approximately 3.4 million workers are employed by hospitals regulated by federal OSHA or states with OSHA-approved plans. Of these perhaps as many as a third, including surgeons, pathologists, dentists and dental technicians, blood bank technicians, phlebotomists, and emergency room, intensive care and operating room nurses and technicians, are at high risk for occupational exposure to these diseases.

In September 1986, OSHA was petitioned by the American Federation of State, County, and Municipal Employees (AFSCME) and by the Service Employees International Union (SEIU), the National Union of Hospital and Healthcare Employees and Local 1199-Drug, Hospital and Healthcare Employees Union. AFSCME requested an emergency temporary standard and a permanent standard on these hazards and the other unions requested a permanent standard on these hazards. OSHA has not yet acted on these petitions.

As the memorandum discusses in detail, the provisions mentioned above may be used in an enforcement effort to protect healthcare workers from exposure to bloodborne diseases. As explained below, however, enforcing the general duty clause as well as general provisions such as Section 132(a) has met with little success in the Commission and the courts. Litigation would have heavy costs in time and money. Even if a section 5(a)(1) case is won, the employer is not mandated to use any particular abatement methods. A permanent health standard, on the other hand, would give superior notice of the hazards and abatement methods. It should also be noted that the presence of the general duty clause and general standards presence of the general duty clause and general standards does not obviate OSHA's duty under section 6(h) of the Act to promulgate specific standards when there is sufficient evidence of a hazard. Cf. Public Citizens Health Research Group v. Auchter, 702 F.2d 1150 (D.C. Cir. 1983)(OSHA required to issue ethylene oxide standard to protect healthcare workers, primarily). As the legislative history of the OSH Act states, the general duty clause was not to be a substitute for reliance on standards. S. Rept. No. 91-2182, 91st Cong., 2nd Sess. (1970), at 9, 10.

II. The Diseases

A. Hepatitis B

Hepatitis B, or "serum hepatitis", is caused by hepatitis B virus (HBV) and is transmitted by body fluids, including blood, and by sexual contact. Many infected individuals do not have symptoms. The onset of acute hepatitis B is long -- 45 to 160 days after exposure. Clinical symptoms include anorexia, malaise, nausea, vomiting, abdominal pain, and jaundice. Although most individuals recover a few die of fulminant hepatic necrosis. Some individuals become chronic carriers of HBV, harboring the virus for years after initial infection. Generally these individuals do not have any overt signs of disease but some develop chronic active hepatitis which can be fatal. Death may also result from cirrhosis or primary hepatocellular carcinoma.

According to data compiled by the OSHA Health Standards Directorate, the estimated annual number of HBV infections in all healthcare workers (HCWs) in the United States is 12,000 to 18,000 and the estimated number of HBV infections in high-risk HCWs is 8,000 to 12,000. The estimated number of clinical hepatitis cases among high-risk HCSs is 2,000-3,000 and the estimated number of deaths among these workers due to hepatitis B is 200-300. The primary means of HBV infection among HCWs are exposure to blood through needlesticks, cuts, and contacts with mucous membranes or other breaks in the skin.

B. Acquired Immunodeficiency Syndrome (AIDS)

Acquired immunodeficiency syndrome is caused by the human immunodeficiency virus (HIV). The virus, transmitted by blood and by sexual contact, infects the lymphocytes, a type of white blood cell that is necessary for the functioning of the body's immune system. Persons who are infected with HIV may have no symptoms, may have AIDS-related complex (ARC), or may manifest the symptoms of overt AIDS. Individuals with ARC often have lymphodenopathy accompanied by fatigue, weight loss and mild immune system abnormalities. Individuals who have AIDS are most often diagnosed when they develop an opportunistic infection such as Pneumocystis carinnii pneumonia (an uncommon infection of the lungs), or certain malignancies such as Kaposi's sarcoma (a very unusual cancer), and have no other underlying cause of immunodeficiency. AIDS is fatal; no vaccine or cure has yet been developed. Over a third of all HIV-positive individuals will develop AIDS and many more will develop ARC.

Currently, of the several thousand HCWs tested in the United States, approximately 8 are infected with HIV as a result of occupational exposure. None of these belong to AIDS high-risk groups. However, the OSHA staff members suspect that there are many more cases and that more testing will reveal these cases. OSHA staff members also feel that the number of HIV-infected HCWs will increase as the AIDS epidemic spreads. Like hepatitis B, the primary means of HIV infection in HCWs are needlestick injuries and blood splashes.

III. Abatement Methods

With one major exception, the abatement methods for preventing HBV and HIV infections in HCWs are the same. On November 30, 1983, OSHA issued guidelines for preventing HBV infections in HCSs. OSHA Instruction CPL 2-2.36. These guidelines are based on the guidelines issued by the Centers for Disease Control (CDC). These methods include: (1) inpatient identification, i.e., placing a card setting forth blood/body fluid precautions on the door or near the bed of an infected patient; (2) use of gloves when there is patient contact or HCWs are involved in procedures in which blood, body fluids, or saliva will be handled; (3) use of gowns; (4) placement of objects likely to be contaminated in puncture-resistant containers; (5) sterilization or decontamination of reusable equipment; (6) handwashing; (7) use of disposable syringes and the prohibition of the recapping or bending of needles; (8) reporting of needlesticks involving potentially contaminated needles to supervisors; (9) proper handling and placement of contaminated linen in laundry bags; (10) the bagging and labeling of contaminated reusable dishes, utensils, and trays; (11) bagging, labeling and disposal of contaminated dressings and paper dressings in accordance with local regulations; (12) labeling, disinfection and bagging of lab specimens; (13) room cleaning; (14) cleaning of blood spills with detergent and water; and (15) use of gloves during the examination of the oropharynx, gastrointestinal tract and genito-urinary tract. The American Hospital Association and the American Occupational Medicine Association have similar guidelines. The use of pulmonary resuscitation equipment is also suggested. Training about hazards and precautions is essential.

Hepatitis B can also be prevented by immunization. A hepatitis B vaccine prepared from human serum became available in 1982. A new vaccine, prepared using recombinant DNA technology, is now available. This vaccine is given in a series of three injections over a six-month period and costs approximately $100. A CDC telephone survey conducted in 1985 indicated that 65 percent of hospitals surveyed had a hepatitis B vaccine program. Small hospitals (those with fewer than 100 beds) are much less likely than large hospitals (those with more than 500 beds) to have a vaccine program, 60 percent versus 90 percent, respectively. Of the hospitals with a vaccine program, 77 percent offer the vaccine at no cost to healthcare workers considered to be at high risk.

IV. Relevant Standards and Statutory Provisions

There are no specific OSHA standards dealing with HCW exposure to bloodborne diseases. Assuming arguendo that bloodborne diseases may properly be considered "hazards of environment," the personal protective equipment standard, 29 CFR 1910.132(a), can be cited in order to require the use of gloves, gowns, masks and other appropriate clothing. OSHA could also cite 29 CFR 1910.22(a)(1), the general housekeeping standard; and 29 CFR 1910.141(a)(4)(ii), a waste disposal standard. Assuming also that OSHA could establish that compliance with standards alone would not eliminate the hazard and that a hazard posing a significant risk would remain, the general duty clause could also be cited. Int'l Union U.A.W. v. General Dynamics Land Systems Div., 815 F. 2d 1570 (D.C. Cir. 1987), pet. for rehearing denied (1987) (Employer not absolved of duty under section 5(a)(1) despite the presence of an applicable OSHA standard if that standard is inadequate to protect workers).

A. 29 CFR 1910.132(a)

The standard provides:

(a) Application. Protective equipment, including personal protective equipment for eyes, face, head, and extremities, protective clothing, respiratory devices and protective shields and barriers, shall be provided, used, and maintained in a sanitary and reliable condition whenever it is necessary by reason of hazards of processes or environment, chemical hazards, radiological hazards, or mechanical irritants encountered in a manner capable of causing injury or impairment in the function of any part of the body through absorption, inhalation or physical contact.

In Kastalon Inc. and Conap Inc., 12 BNA OSHC 1928 (Nos. 79-3561 and 79-5543, 1986) the Commission held that under section 132(a), as in general duty clause cases, the Secretary must show that a significant risk to employees is present because the standard does not presume the existence of the hazard. In support of the holding the Commission cited, inter alia, Donovan v. General Motors Corp., 764 F.2d 32 (1st Cir. 1985) and Modern Drop Forge Co. v. Secretary of Labor, 683 F.2d 1105, 1114-15 (7th Cir. 1982). The Commission vacated the 29 CFR 1910.132(a) citation for exposure to MOCA, a carcinogen, for the same reason it vacated the section 5(a)(1) citations, i.e. the Secretary's failure to show a significant risk of harm.

We think that we could establish a violation of Section 132(a) if an employer were not providing its exposed HCWs with personal protective equipment such as masks, gloves and gowns. First, bloodborne diseases can be considered to be a "hazard of processes or environment" within the meaning of the standard. The processes involved here are the healthcare activities such as handling infected patients. Hazard of environment within the meaning of the standard would include the splashed acid is a hazard of the environment covered by the standard. For the reasons given in our discussion of the general duty clause below, HCWs are exposed to a "hazard," i.e. significant risk of harm. Finally, gloves, gowns, and pulmonary resuscitation equipment have been suggested as appropriate personal protective equipment.

B. 29 CFR 1910.22(a)(1) and 29 CFR 1910.141(a)(4)(ii)

The standard at 29 CFR 1910.22(a)(1) provides:

(a) Housekeeping. (1) All places of employment, passageways, storerooms, and service rooms shall be kept clean and orderly and in a sanitary condition.

This standard has been construed to apply to all hazards resulting from an unclean, disorderly, or unsanitary place of employment. Bunge Corp. v. Secretary of Labor & OSHRC, of employment. Bunge Corp. v. Secretary of Labor & OSHRC, 638 F.2d 831 (5th Cir. 1981); Con Aqra, Inc. v. OSHRC, 672 F.2d 699 (8th Cir. 1982).

The standard at 29 CFR 1910.141(a)(4)(ii) provides:

(ii) All sweepings, solid or liquid wastes, refuse, and garbage shall be removed in such a manner as to avoid creating a menace to health and as often as necessary or appropriate to maintain the place of employment in a sanitary condition.

There are no reported cases on this provision.

Section 1910.22(a)(1) could be cited if the employer failed to clean up blood spills or if contaminated needles or other debris were scattered on the floor. Section 1910.141(a)(4) dealing with the removal of refuse, could be cited if needles and other contaminated debris like dressings or contaminated tissues were not placed in impervious bags, for example.

C. Section 5(a)(1)

The section provides:

Each employer--

(1) shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.

To establish a violation of section 5(a)(1), the Secretary must show (1) that a condition or activity in the employer's workplace presented a hazard to employees, (2) the cited employer or the employer's industry recognized that hazard, (3) that the hazard was likely to cause death or serious physical harm, and (4) that feasible means existed to eliminate or materially reduce the hazard. Kastalon Inc. and Conap Inc., 12 BNA OSHA 1928 (Nos. 79-3561 and 79-5543, 1986); Pelron Corp., 12 BNA OSHC 1833 (No. 82-388, 1986); Davey Tree Expert Co., 11 BNA OSHA 1898 (No. 77-2350, 1984).

With respect to the first element, the Commission ruled in Kastalon, supra, at 1931-32, that the Secretary must show a significant risk of harm as he must when he promulgates a standard. Industrial Union Department, AFL-CIO v. American Petroleum Institute, 448 U.S. 607 (1980) (the Benzene case). In Kastalon, supra, OSHA cited an employer for exposure to MOCA, a chemical which is known to cause cancer in animals but with respect to which there is no evidence directly linking it to any human cancer. The Secretary's expert had done a quantitative risk assessment based on animal studies. Assuming that a worker would receive a total dose of 14 grams per kilogram of body weight after 39 years, he postulated that the worker would be at a 100% risk of contracting cancer after 39 years. The Commission held that to establish a significant risk in a section 5(a)(1) case involving a carcinogen, the Secretary must show the probability that employees will contract cancer under the conditions present in the workplace. The Commission found that the Secretary's expert's assumption of the amount of exposure to MOCA was inaccurate because it was based on the urine test of only a few employees on a single day and because there was no evidence on the amount of MOCA in Kastalon's employees' urine. The Commission also concluded that other assumptions made by the Secretary's expert to extrapolate human risk from the animal studies were too speculative for the purposes of section 5(a)(1) citation because the Secretary had not proven the first element.

It should be noted, however, that the Commission has affirmed a section 5(a)(1) citation involving exposure to anthrax. Peter Cooper Corporations, 10 BNA OSHC 1203 (No. 76-596, 1981). In that case employees were exposed to anthrax from animal bones used in making gelatin. The Commission noted, inter alia, medical journal articles introduced into evidence by the Secretary dealing with anthrax among employees who handled imported bones. The Commission concluded that there was a hazard on the basis of the presence of anthrax bacteria in the workplace, several incidences of anthrax infection at the employer's facility, as well as expert testimony about the dangers of anthrax to workers handling imported bones. The Commission also concluded that the hazard was recognized because the employer's general manager was aware of the danger. The Commission also found that the hazard was likely to cause death or serious physical harm because the mortality rate for cutaneous anthrax is 10 to 20 percent if the patient does not receive an effective antibiotic. Finally, the Commission concluded that inoculation was a feasible abatement method, partially on the basis of a CDC recommendation.

To the extent that the standards do not completely cover the hazards to healthcare workers associated with bloodborne diseases OSHA could properly cite an employer for violating section 5(a)(1). Any citation would have to address conditions with respect to both hepatitis B and AIDS. Although the scientific evidence does support the idea that HIV can be transmitted occupationally to HCWs, these data are incomplete and this lack of quantitative evidence would make it difficult to prove that there is a significant risk of harm under the stringent Kastalon test. However, the AIDS danger could be included in a citation primarily dealing with hepatitis B.

The case for citing section 5(a)(1) in hepatitis B situations was made by T. Timothy Ryan, Jr., a former Solicitor of Labor, and Attorney Robert J. Aamoth(1) in an article entitled "Hepatitis B: An Occupational Hazard for Health Personnel" printed in Health Matrix: The Quarterly Journal of Health Services Management, Vol. II, No. 4. Furthermore, the North Carolina OSHA agency has in an opinion letter construed its general duty clause to require employers to take steps to protect HCWs from hepatitis B.

________
FOOTNOTE(1)  These attorneys are partner and associate at Pierson, Ball &
Dowd, counsel to Merck, Sharp & Dohme, which manufacturers a hepatitis B
vaccine.
________
There is no question that the hazard (HBV or HIV) is likely to cause death
or serious physical harm.  As pointed out above, the symptoms of hepatitis B
include, inter alia, nausea, anorexia, vomiting, and jaundice.  It is also
fatal for some infected individuals.  AIDS is fatal, and although not all
persons with HIV infections develop AIDS, over a third of them do and many
other seropositive individuals develop ARC.

As the Ryan and Aamoth article states, the employment conditions in many health care facilities plainly increase the likelihood that at-risk employees will contract hepatitis B. The risk embodied in these conditions thus constitutes an occupational hazard. Arguably, OSHA would not have to show the presence of patients with hepatitis B (or AIDS) at a particular hospital. See Brock v. City Oil Well Service C., 795 F.2d 507 (5th Cir. 1986)(the Secretary in showing a violation of the general respirator standard does not have to show that the toxic gases were actually present at the worksite; the fact that the presence of the toxic gas is a constant risk at a worksite like the cited employer's is sufficient to show the hazard). However, if the Commission is very strict about showing that there is a hazard actually at the cited workplace, as in Kastalon, supra, the Secretary would have to prove that patients with the viruses were actually present in the hospital. The Secretary would than probably have to obtain hospital medical records or present evidence about an HCW at the cited hospital who was infected and who would not have been infected in any way other than occupationally. If the Secretary attempted to obtain hospital medical records, privacy objections could be raised. However, with the deletion of personal identifiers, these objections might be surmounted.

The hazard of HCW exposure to hepatitis B is recognized by health and safety experts familiar with the health care industry. The United States Public Health Immunization Practices Advisory Committee, the Centers for Disease Control, the Advisory Committee on Infections Within Hospitals of the American Hospital Association, the American College of Physicians, the Committee on Medical Center Employee Occupational Health Services of the American Occupational Medicine Association, occupational safety officials in Oregon and North Carolina, and numerous researchers and commentators have recognized this hazard.

As Ryan and Aamoth and previous portions of this memorandum point out, there are feasible abatement methods, including, inter alia, inpatient identification, sterilization, and decontamination. Training is also important and has been requested by the petitioning unions (the hazard communication standard does not cover nor does OSHA plan to have it cover infectious diseases). With respect to hepatitis B, inoculation is a feasible abatement method, as in Peter Cooper, supra.

VI. Conclusion

Based upon our analysis to date, we believe that it would be appropriate to cite for violations of section 5(a)(1) and the standards discussed above in cases in which employers failed to adequately protect their health care workers from the hazards of bloodborne diseases. However, we should be very selective about the cases that we bring to trial in light of the fact that we have had very little success with section 5(a)(1) cases. Between April 1983 and December 1986 we have lost all section 5(a)(1) cases before the Commission on review. We will need to be prepared to use the best available experts to support our litigation efforts. Proof that employees are exposed to a hazard will require a mini-rulemaking in each case.