Sep 9, 1986 - Labeling of Formaldehyde-Containing Products Under the Hazard Communication StandardSep 9, 1986 - Labeling of Formaldehyde-Containing Products Under…
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OSHA Hazard Communication Letters of Interpretation
Labeling of Formaldehyde-Containing Products Under the Hazard Communication Standard
ILPI assessment: Cancer warning principle retained; current criteria and wording govern
This letter addresses the original 1983 Hazard Communication Standard (HCS), which is now obsolete. Its need to communicate formaldehyde's cancer hazard remains valid, but current duties do not depend on finding a positive human study before animal evidence can matter. Apply current carcinogenicity criteria and the formaldehyde-specific 1910.1048(m) hazard-communication provisions, including their coverage and labeling conditions.
This comparison with current requirements is not a finding that OSHA has formally withdrawn this letter. This assessment reflects editorial judgment informed by human review and AI assistance. It is an opinion, may contain errors or omissions, and is not an official OSHA determination. For guidance on how OSHA requirements apply to your circumstances, contact your local OSHA office.
OSHA's notice about interpretation letters
The following notice is published on OSHA's interpretation pages; it is general guidance, not a letter-specific withdrawal notice.
OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.
Several parties have asked for guidance on the subject issue. The Hazard Communication Standard (HCS) does not establish a clear threshold for the inclusion of hazard warnings on product labels. The term "appropriate hazard warning" found under 29 CFR 1910.1200(f) is the determining factor in the standard's labeling requirements.
While it is not the Agency's intent to provide specifications that might erode the standard's inherent flexibility, it is necessary to establish guidelines to ensure uniformity in our enforcement evaluations of employer programs. Guidelines were published originally on May 16, 1986 and further refined recently on July 18 in OSHA Instruction CPL 2-2.38A and CPL 2-2.38A CH-1 (pages A-12 through A-18). The guidelines provide criteria that are summarized in Table 1 of the directive on page A-18. These guidelines establish the presence of a single valid, positive study showing human evidence of carcinogenicity as a sufficient basis for the inclusion of a carcinogen warning on product labels.
In a recent formaldehyde rulemaking proposal (50 FR 50412), the Agency considered the epidemiological evidence as suggestive based on a consideration of all available evidence. There are, however, several valid, positive studies showing human carcinogenicity. The following are examples (all exhibit numbers refer to the formaldehyde docket, number H225 and H225A):
Stroup, Exhibit 73-42
Acheson et al., Exhibit 42-
Blair et al., (recent NCI report)
Olsen et al., Exhibit 73-36
In addition, formaldehyde has been tested and shown to cause cancer in three separate animal studies by CIIT (Exhibit 42-131), New Research (Exhibits 42-3, 42-4) and (Exhibit 73-146) Carcinogenicity has also been documented through several short term essays.
Health professionals must employ a large measure of judgment when making decisions about the appropriateness of a label warning. They must keep in mind that the HCS is primarily an information standard and as such expresses an intent to disclose information rather than to withhold information. Accordingly label warnings stating the carcinogenic potential for formaldehyde will generally be required under the HCS.
The specific words or phrases used to warn of formaldehyde carcinogenicity will vary. Compliance officers should expect to see warnings such as "CARCINOGEN," POTENTIAL CARCINOGEN," and "ANIMAL CARCINOGEN." Others will incorporate modifying statements such as "INCONCLUSIVE EVIDENCE OF HUMAN CARCINOGENICITY." Wide latitude should be permitted as long as the label being evaluated warns of the potential cancer risk.