March 22, 1995

Haward J. Cohen, Ph.D, CIH
University of New Haven
Gatehouse 300 Orange Avenue
West Haven, Connecticut 06516

Dear Dr. Cohen:

Thank you for your letter of December 28, 1994, addressed to Thomas Galassi of my staff concerning clarification of the agency's position on the application of your Triazine Joint Venture (JV) study to the Formaldehyde Standard (29 CFR 1910.1048). This letter serves as a response to your letter and a follow up to my December 1, 1994 letter and the September 30, 1994 meeting between representatives of the Independent Lubricating Manufacturing Association (ILMA) and the Occupational Safety and Health Administration (OSHA). In your recent letter you specifically requested a written response to clarify issues related to the JV study and its use as objective data under the Formaldehyde Standard.

Given the extensive communications between the interested parties, we feel it would be useful to recount the pertinent activities. The following is a brief description of the OSHA's participation in the review of the JV study. On July 19, 1994, Mr. Ike Tripp of the ILMA, sent a letter to OSHA requesting evaluation of your Joint Venture study. A meeting was held at OSHA's National Office on September 30, 1994, with yourself, members of the ILMA, and Dr. Edward Stein and Thomas Galassi of OSHA. Following a coordinated review by various branches of OSHA, we sent a letter to Mr. Tripp on December 1, 1994, that summarized our review of the JV study. Based on that review it appeared to us that it demonstrated formaldehyde release from the biocide "Triazine" in excess of 0.1 ppm (8-hour time weighted average), and we stated that in our letter. You have provided additional information to the agency in your December 28, 1994, letter and you stated that: "It would be my opinion that the use of concentrated Triazine, as specified in the study, will not result in detectable employee exposures to formaldehyde and that such exposures would be below 0.1 ppm as an eight-hour time weighted average."

OSHA's policy on this issue is that the determination of the presence and extent of any associated hazard is always the responsibility of the chemical manufacturer or importer of the formaldehyde product. This evaluation must assess the hazards associated with actual or potential worker exposures, including all routes of entry, that may occur under reasonably foreseeable conditions. In terms of the Formaldehyde Standard, it is the responsibility of the manufacturer and/or importer to establish what the level of formaldehyde release is (i.e., greater than 1%) and label, train and develop MSDS accordingly.

Therefore, the course of action described in your letter is consistent with the provisions of the Formaldehyde Standard. However, OSHA compliance personnel may at their discretion during an inspection evaluate the "Triazine" containing cutting fluids for formaldehyde hazards at individual worksites.

In response to the misuse of the term "ceiling" in our letter, the 0.1 ppm level specified in paragraph 29 CFR 1910.1048(m) of the formaldehyde standard is an eight hour time weighted average and not a ceiling level as we indicated. Given its meaning in the OSHA regulations, we regret the use of the word "ceiling" within the context of that Paragraph.

We hope this response meets your needs.

Sincerely,

John B. Miles, Jr., Director
Directorate of Compliance Programs

Enclosure

December 28, 1994

Mr. Thomas Galassi, CIH
Occupational Safety and Health Administration
U.S. Department of Labor
Room N3467
200 Constitution Avenue, N.W.
Washington, D.C. 20210

Dear Mr. Galassi:

It was a pleasure meeting with you in September, and more recently discussing with you over the telephone the study of formaldehyde exposures that was performed on behalf of the Triazine Joint Venture (JV). There are several points which I would like to clarify with this letter, including the use of objective data to assess the need for monitoring and hazard communication as required by the OSHA Formaldehyde Standard.

The first point we discussed over the phone is the misunderstanding by representatives of OSHA regarding the actual concentration of formaldehyde present in both Triazine and metalworking fluid containing Triazine, and its relationship to listing hazardous ingredients as specified in the OSHA Hazard Communication Standard (CFR 1910.1200). When members of the JV met in early 1993 to discuss the protocol for a formaldehyde exposure study, representatives all shared information that each of their Triazine products contained less than 1000 ppm of formaldehyde (generally, less than 100 ppm of formaldehyde). This would exempt Triazine from specific labelling and warnings due to the presence of a suspect carcinogen at less than 0.1% in solution. It would also exempt metalworking fluid containing Triazine, since this biocide is diluted approximately 1:1000 in metalworking fluid bringing the actual concentration of formaldehyde down to less than 0.0001% or less than one part per million (ppm) in solution. The sole issue facing members of the JV and their customers is whether the use of Triazine-containing metalworking fluids may produce exposures of formaldehyde above 0.1 ppm, requiring hazard communication training and labelling as specified in the final OSHA Formaldehyde Standard (29 CFR 1910.1048). This was the purpose of the study I directed.

The second issue is an apparent error in the letter issued by John Miles, Jr. to Ike Tripp, Jr. at the Independent Lubrication Manufacturers Association (ILMA) dated December 1, 1994. In the third paragraph of Mr. Miles' letter he refers to the threshold for labelling and warning on MSDSs as employee exposure of 0.1 ppm level or more of formaldehyde as determined both by an eight-hour time-weighted average and as a ceiling value. It is my understanding from reading the preamble of the final Formaldehyde Standard, and from previous letters of interpretation by representatives of OSHA, that the 0.1 ppm exposure limit is defined as an eight-hour time-weighted average. This is a crucial point in interpreting the results of the JV formaldehyde study.

The final issue is a clarification on the use of the JV formaldehyde study by groups including the JV and ILMA. It is my understanding from our discussions that the hazard communications provisions of the Formaldehyde Standard are performance based and interpretations of how the JV study relates to the 0.1 ppm exposure limit is left at the discretion of individual users and manufacturers rather than OSHA. I am proposing to write a letter, or have others do the same, to any interested parties which wish an interpretation of the JV formaldehyde study. It would be my opinion that results of this study demonstrate that the use of concentrated Triazine, as specified in the study, will not result in detectable employee exposures to formaldehyde, and that such exposures would be below 0.1 ppm as an eight-hour time-weighted average. This conclusion is based on the careful evaluation of data when concentrated Triazine was added to the metalworking fluid system, which should represent the highest exposure likely from this product. I would further indicate that background levels at a number of facilities and uncertainty in the measurement process allow for the possibility that results of both area and personal monitoring for formaldehyde may at times exceed 0.1 ppm as a time-weighted average in some locations using Triazine. However, this exposure cannot be determined to be caused by the use of Triazine.

I would request a letter back from you or Mr. Miles which clarifies that the 0.1 ppm limit for formaldehyde labelling and warning is as an eight-hour time-weighted average, and that the course of action indicated above is consistent with the provisions of the OSHA Formaldehyde Standard regarding the use of objective data to determine labelling and hazard communication training.

Let me thank Ed Stein and yourself for taking the time and effort to clarify these specific requirements of the OSHA Formaldehyde Standard. I look forward to hearing from you or Mr. Miles in the future, and please feel free to contact me at the University of New Haven at 203-932-7238 should you have any questions.

Sincerely,

Howard J. Cohen, Ph.D., CIH
Study Director for the JV Formaldehyde Study

Enclosure

January 26, 1995

Mr. John B. Miles, Jr.
Directorate of Compliance Programs
U.S. Department of Labor Occupational
Safety and Health Administration
Room N3467
200 Constitution Avenue, N.W.
Washington, DC 20210

Dear Mr. Miles:

The Independent Lubricant Manufacturers Association ("ILMA") has received your letter, dated December 1, 1994, addressed to Ike Tripp, Jr., immediate past president of ILMA. The Association appreciates your correspondence, as well as the attention and hard work of your staffs especially Tom Galassi and Dr. Ed Stein. They have been extremely receptive to working with us to resolve interpretation issues associated with the Triazine Joint Venture's Study under the Formaldehyde Standard.

Your December 1 letter crossed in the mail with correspondence from ILMA in follow-up to our September 30, 1994 meeting with Mr. Galassi and Dr. Stein. Moreover, we understand that Dr. Howard Cohen, the principal researcher for the Triazine Joint Venture Study, also has submitted additional comments and information to the Occupational Safety and Health Administration. Accordingly, ILMA is continuing to work with Mr. Galassi and Dr. Stein in addressing this matter.

Sincerely,

John C. Steigerwald
President

Enclosure

cc: ILMA Triazine Task Force Triazine Joint Venture Dr. Howard Cohen Jeffrey L. Leiter, Esq. Stephanie Siegel, Esq. Tom Galassi Dr. Edward Stein

December 1, 1994

Mr. Ike Tripp, Jr.
President Independent Lubricant Manufacturers Association
651 S. Washington Street
Alexandria, Virginia 22314

Dear Mr. Tripp:

This is in further response to your letters July 19, and follow up letter of August 10, addressed to Mr. Joseph A. Dear, Assistant Secretary for the Occupational Safety and Health Administration (OSHA), requesting an interpretation of the Formaldehyde Standard, 29 CFR 1910.1048. Specifically, you indicated that a study entitled "A Study of Formaldehyde Exposure from Metalworking Fluid Operations Using Hexahydro-1,3,5-Tris (2-Hydroxyethyl) S-Triazine" published on May 3, by Dr. Howard Cohen, Ph.D., on the release of formaldehyde when using a commercially available biocide Triazinell will not exceed 0.1 ppm when typically used in the metalworking industry. As a consequence of that study and your understanding of the Formaldehyde rule, you concluded that section 29 CFR 1910.1048(m) of the standard does not apply, and that the metalworking industry can use the data to demonstrate the trivial (below 0.1 ppm) exposure for the metalworking industry.

A meeting was held on August 30, where you and other ILMA representatives met with OSHA representatives, Thomas Galassi and Edward Stein, to further discuss the study and it's implication to the standard. We understand the meeting was productive and raised a number of important issues.

OSHA's position on the standard's 0.1 ppm (8 hour Time Weighted Average) "trigger" for coverage of a product containing formaldehyde has been discussed in the preamble to the final formaldehyde rule (57 FR 102, page 22297), which states the following: "Formaldehyde-containing products incapable of causing exposures at or above 0.1 ppm or mixtures and solutions containing less than 0.1% formaldehyde will not be subject to any hazard communication requirements." In addition, on page 22298 of the preamble it reads: "The labeling requirement is intended to apply to the maximum potential emission under foreseeable conditions." OSHA's intent was that the 0.1 ppm level represent a ceiling value and not a statistical upper confidence interval. The level of precision associated with the sampling and analytical method can be considered in the 0.1 ppm determination.

OSHA reviewed the study report, submitted by the ILMA on July 19, and the agency's conclusions are in agreement with the study's author (refer to last paragraph of report's executive summary). In that document Dr. Cohen stated the following: "Unless employers have their own exposure data indicating formaldehyde levels below 0.1 ppm, a conservative approach would suggest employers follow the requirements of the formaldehyde standard. These include modifying existing hazard communication training..." Essentially, the agency finds Dr. Cohen's conclusion to be prudent.

It is the agency's view that the data in your study demonstrates that Triazine is capable of formaldehyde release at the 0.1 ppm level. We base this conclusion on the results presented for the 8 locations monitored. There are a number of instances where personal and area samples were" found to be in above than the 0.1 ppm level. This is also true when the data is adjusted for background (control) levels and sampling and analytical error.

On pages 33 to 38 of the report, in the section "Additional Laboratory Studies," you investigated the relationship between the concentration of formaldehyde in a synthetic metalworking fluid and the concentration of formaldehyde in the headspace. Your results clearly indicated that at typical triazine metalworking concentrations (500-1000 ppm), formaldehyde air concentrations in the headspace above were well over 0.1 ppm.

You raised the issues of high imprecision surrounding the sampling and analysis of formaldehyde at 0.1 ppm, and the unknown contribution of formaldehyde background levels to the sampling results in some of the monitored plants. We agree that these factors appear to obscure or introduce uncertainty into the conclusions you wish to draw. However, even when these factors are accounted for, the evidence indicates that Triazine is capable of exceeding 0.1 ppm.

We hope this response provides you with the necessary guidance of the formaldehyde standard to properly interpret the data. Please bear in mind that the final determination of compliance must take into account factors pertaining to the use of metalworking fluids at a particular worksite. This must include an on-site evaluation by an OSHA Compliance Officer.

Please accept my commendation for performing this study. It clearly provides important health hazard information to your industry, and promotes the health and safety of the workers. Should you have additional questions, please feel free to contact OSHA's Office of Health Compliance Assistance at (202) 219-8036.

Sincerely,

John B. Miles, Jr., Director Directorate of Compliance Programs