I. Background and History of the Regulation

On December 4, 1987, after an extensive rulemaking proceeding, detailed in the preamble to the final rule (52 FR at 46169-46171), OSHA issued a comprehensive regulation covering occupational exposure to formaldehyde at 29 CFR 1910.1048. This rule reduced the permissible exposure limits (PELs) to 1 part formaldehyde per million parts of air (ppm) as an 8-hour time-weighted average (TWA), and established a 2 ppm 15-minute short term exposure limit (STEL). The comprehensive standard also included an "action level" of 0.5 ppm, measured as an 8-hour TWA, and provisions for employee exposure monitoring, medical surveillance, recordkeeping, regulated areas, emergency procedures, preferred methods to control exposure, maintenance and selection of personal protective equipment, and hazard communication. OSHA's rule was based on the consideration of a wide range of new evidence including animal bioassays and epidemiological evidence. It was based in part on OSHA's recognition of formaldehyde as a potential occupational carcinogen as well as its irritating and sensitizing effects.

The standard was challenged in the United States Court of Appeals for the District of Columbia Circuit, pursuant to section 6(f) of the Act, 29 U.S.C. 655(f), by both industry and labor. Four unions, the International Union, United Automobile, Aerospace and Agricultural Implement Workers of America (UAW), the Amalgamated Clothing and Textile Workers Union (ACTWU), the International Ladies' Garment Workers Union (ILGWU) and the International Molders and Allied Workers Union, and Public Citizen, a public interest group, challenged the standard as being insufficiently protective. They contended that the PEL was not set low enough to eliminate all significant risk of harm from both cancer and from formaldehyde's irritant effects. They also objected to OSHA's decision not to include a medical removal protection (MRP) provision in the standard, and to a number of other aspects of the standard, including the setting of the action level, the lack of a requirement for annual medical examinations, and the provisions regarding labeling and training.

The Formaldehyde Institute (FI), on the other hand, sought review of the hazard communication provisions in paragraph (m) of the standard. While challenging these provisions in court, the FI, along with others, petitioned OSHA for an administrative stay of the hazard communication provisions and reconsideration of these provisions. On December 13, 1988, after giving the public an opportunity to comment on this petition, OSHA stayed the hazard communication provisions, paragraphs (m)(1)(i) through (m)(4)(ii), and announced its intention to consider further regulatory action on these provisions (53 FR 50198). The effect of the stay was to continue the implementation of OSHA's generic Hazard Communication Standard (29 CFR 1910.1200) in effect with respect to formaldehyde. The administrative stay was subsequently continued to allow the Agency more time to resolve the issue (54 FR 35639, 8/29/89; 55 FR 24070, 6/13/90; 55 FR 32616, 8/10/90; 55 FR 51698, 12/17/90; 56 FR 10377, 3/12/91; 56 FR 26909, 6/12/91; 56 FR 37651, 8/8/91); 56 FR 57593, 11/13/91; 57 FR 2681, 1/23/92).

The Court of Appeals affirmed the final standard in most respects but concluded that OSHA had failed adequately to explain its cancer risk estimates and why it had not included medical removal protection (MRP) provisions in the standard. UAW v. Pendergrass, 878 F.2d 389 (D.C. Cir. 1989). The Court's decision required OSHA to better explain or reevaluate the risk assessment that led it to choose a PEL of 1 ppm. According to the Court, should OSHA conclude that a significant risk remains at 1 ppm, the Agency could then adjust the standard accordingly. The Court's decision also required OSHA to better explain or reevaluate its decision not to include an MRP provision in the standard.

The Court did not review the hazard communication provisions of the standard because they had been administratively stayed for reconsideration at the time. Because all of the provisions of the standard are interconnected, OSHA determined that the hazard communication provisions should be reconsidered together with the remand issues.

[57 FR 22290, May 27, 1992]