Regulations (Preambles to Final Rules) - Table of Contents Regulations (Preambles to Final Rules) - Table of Contents
• Record Type: Occupational Exposure to 4,4' Methylenedianiline (MDA)
• Section: 3
• Title: Section 3 - III. Events Leading to the Final Standard

III. Events Leading to the Final Standard

EPA issued a notice under Section 4(f) of the Toxic Substances Control Act (TSCA) on April 27, 1983 (48 FR 19078) which indicated that MDA presents a significant cancer risk to humans. EPA was then required to either initiate "appropriate action" or announce that the risk was not "unreasonable."

The Section 4(f) notice was based on a draft study undertaken by the National Toxicology Program (NTP). The study demonstrated that the dihydrochloride salt of MDA is carcinogenic in both sexes of rats and mice at two oral dose levels. This study plus the following factors formed the basis for the Section 4 (f) notice: (1) a lack of any mandatory workplace standard; (2) the apparent inadequacy of protection afforded at the American Conference of Governmental Industrial Hygienists (ACGIH) recommended threshold limit value (0.1 parts per million (ppm)); (3) evidence that some processors may be exceeding even the ACGIH limit; and (4) evidence that several thousand workers may be exposed.

The "appropriate action" taken by EPA was the issuance of an Advance Notice of Proposed Rulemaking (ANPR) on September 20, 1983 (48 FR 42898). The ANPR announced the joint effort by EPA and OSHA to initiate regulatory action to determine and implement the most effective means of controlling occupational exposure to MDA. At the time of the issuance of the ANPR, only limited data were available on exposure levels and the number of workers potentially exposed. The ANPR requested detailed information on the operations used to manufacture and process MDA; the potential for exposure at each stage, including air and work surface monitoring data; and descriptions of workplace practices. The second area of inquiry was the production and use of MDA. Detailed descriptions of the uses of MDA and updated information of the identity of processors and users was sought. The third area of inquiry was the availability, costs, and the suitability, and toxicity of substitutes for MDA. Finally, information was sought on methods of controlling exposure. The ANPR invited views and data from interested parties in any of these areas.

In response to the ANPR, comments were received from four parties:

Diamond Shamrock; National Resources Defense Council, Inc.; DuPont; and CMA. These comments have been analyzed and where appropriate are reflected in this document.

On July 5, 1985, EPA published a Federal Register notice, in accordance with section 9 TSCA provisions (50 FR 27674) which described the occupational risks associated with worker exposure to MDA and requested that OSHA respond to EPA and indicate what regulatory activity would be implemented, if any. Under section 9(a)(2) of TSCA, EPA was prohibited from taking any regulatory action pending a response from OSHA.

In response (51 FR 6748, February 26, 1986), OSHA determined that there is a reasonable basis to believe that the manufacture and use of MDA presents a significant risk to the health of exposed workers and that the risk described by EPA may be eliminated or reduced to a significant extent by a workplace standard which regulates workers exposure. Further, OSHA determined on the basis of preliminary data, that the adoption of an occupational standard for worker exposure to MDA is economically and technologically feasible.

In the course of considering an appropriate regulatory action under the Occupational Safety and Health Act of 1970 (84 Stat. 1590; 29 U.S.C. 655) ("OSH Act"), OSHA examined various regulatory scenarios before determining the process which might be followed in developing a comprehensive regulation for occupational exposure to MDA. The Administrative Conference of the United States (ACUS) had recently studied the rulemaking process of various federal agencies and found that:

The complexity of government regulation has increased greatly compared to that which existed when the Administrative Procedure Act [APA] was enacted, and this complexity has been accompanied by a formalization of the rulemaking process beyond the brief, expeditious notice and comment procedures envisioned by section 553 of the APA. Procedures in addition to notice and comment may, in some instances, provide important safeguards against arbitrary or capricious decisions by agencies and help ensure that agencies develop sound factual basis for the exercise of the discretion entrusted them by Congress, but the increased formalization of the rulemaking process has also had adverse consequences. The participants, including the agency, tend to develop adversarial relationships with each other causing them to take extreme positions, to withhold information from one another, and to attack the legitimacy of opposing positions. Because of the adversarial relationships, participants often do not focus on creative solutions to problems, ranking of the issues involved in a rulemaking, or the important details involved in a rule. Extensive factual records are often developed beyond what is necessary. Long periods of delay result and participation in rulemaking proceedings can become needlessly expensive. Moreover, many participants perceive their roles in the rulemaking proceeding more as positioning themselves for the subsequent judicial review than as contributing to a solution on the merits at the administrative level. Finally, many participants remain dissatisfied with the policy judgments made at the outcome of rulemaking proceedings.

(Recommendation 82-4 "Procedures for Negotiating Proposed Regulations," 47 FR 30708, June 18, 1982).

Therefore, ACUS recommended that agencies consider using regulatory mediation, in which the parties in interest identify the major issues, gauge their importance, identify the information necessary to resolve the issues, and develop a rule that is acceptable to the respective interests, all within the contours of the regulatory agency's statute.

In considering whether this approach would be suitable in developing regulations controlling workplace exposure to MDA, OSHA considered the selection criteria adopted by the Environmental Protection Agency. (See 49 FR 17576, 17579; April 24, 1984.) OSHA concluded that MDA met the selection criteria for mediation: the regulatory effort was at the pre-proposal phase of development; affected parties were relatively few in number and readily identifiable; there were indications that affected parties would mediate in good faith; and sufficient information was available to resolve key issues. Thus, OSHA employed mediated rulemaking in developing an occupational standard for worker exposure to MDA.

A number of parties interested in OSHA affairs have expressed concern regarding the use of mediated rulemaking in developing complex health regulations. Strictly speaking, it appears inappropriate to suggest that human suffering and lives become the trade off items in a mediation attempt. The Agency's use of mediated rulemaking in this instance did not anticipate that would be the methodology of these endeavors. Instead, OSHA expected to produce a consensus recommendation on the various aspects or issues involved in developing a complex health standard. This differs from the typical labor-management negotiations where a limited number of issues must be resolved and bargaining or trade-off become the method to form a compromise. The key difference involves the final product expected. On the one hand, a compromise is reached; on the other hand, a consensus is achieved.

OSHA indicated in its Federal Register notice of October 22, 1985 (50 FR 42789) that Mediated Rulemaking would be used to assist OSHA in its MDA rulemaking activities. This notice also set forth the basic concepts of negotiated rulemaking and outlined the participant selection criteria which OSHA expected to use in establishing an MDA Advisory Committee.

OSHA established the committee in accordance with the Federal Advisory Committee Act (FACA, 5 U.S.C. App. I); and section 7(b) of the Occupational Safety and Health Act (OSH Act; 29 U.S.C. 656 (b)) to mediate issues associated with the development of a Notice of Proposed Rulemaking (NPRM) on MDA.

This notice also solicited participants for the mediation process. As a result of the request for participants, three unions, the United Auto Workers (UAW), the United Steelworkers of America (USWA) and the Oil, Chemical, and Atomic Workers (OCAW) offered names of potential representatives for the Committee. OSHA selected representatives from the UAW and Steelworkers to participate in these mediation activities. The International Association of Machinists and Aerospace Workers (IAM) submitted a request for representation on the Committee and a representative from this group was appointed. Later, as a result of scheduling conflicts, the UAW representative resigned and was replaced by a labor representative from the United Brotherhood of Carpenters and Joiners of America.

In addition to the unions that nominated participants, three trade associations representing employer groups also expressed an interest in participating in this rulemaking effort: the National Electrical Manufacturers Association (NEMA), the Suppliers of Advanced Composite Materials Association (SACMA) and the Chemical Manufacturers Association (CMA). Representatives from these groups reflect employer interest in primary and secondary manufacturing and, to some extent, downstream use of MDA in the construction industry. The other recommendations for representation came from the Department of Energy, Brookhaven National Laboratory, Sandia National Laboratories, the National Institute for Occupational Safety and Health (NIOSH), EPA, and the Occupational Safety and Health Administration for the State of California. A list of the candidates selected, the date of the first meeting, and the agenda for the first meeting were published in the Federal Register on July 3, 1986 (51 FR 24452).

OSHA also clearly denoted, in the October 22nd notice, the relevance which the Mediated Rulemaking efforts would have in the development of its proposed rule for occupational exposure to MDA:

While the Committee's work product will likely serve as the basis for a proposed rule, it will not negate the need for adherence to traditional rulemaking procedures. This negotiated rulemaking procedure is supplemental to the normal section 6(b) rulemaking procedures specified in the OSH Act and is intended to aid OSHA in developing a proposed standard for occupational exposure to MDA (at 42790).

Furthermore, OSHA's participation in these mediated rulemaking endeavors was clearly delineated and was, in fact, to be substantial. OSHA would be an active participant in these efforts. An OSHA representative provided draft regulatory text and the necessary expertise in standard drafting which the Committee needed.

To the extent that OSHA could not accept the Committee's recommendations as its notice of proposed rulemaking, OSHA agreed to publish its rationale for such non-acceptance. OSHA, for the most part, based its NPRM on the Committee's recommendations.

In addition, OSHA's approach entailed the Agency setting forth the issues on which the Committee must come to consensus. OSHA had the knowledge and experience needed to develop complex health standards. Furthermore, OSHA is cognizant of its own legal requirements and limitations. Thus, OSHA provided the Committee with the issues to be resolved, the record evidence accumulated to date, and the suggested draft regulatory language. The Committee used the record evidence and draft language provided by OSHA, along with information supplied by some of its members and, of course, the personal expertise of its members to achieve its consensus recommendations. The recommendations developed by the Committee reflect the consensus reached regarding the risk associated with occupational exposure to MDA, the PELs and standard provisions necessary to reduce this risk, and the technological and economic feasibility of implementing these standards. The Committee's products were comprehensive regulations with accompanying rationales.

The Committee also agreed that unanimous agreement on all the issues was not necessary for consensus to be reached. This is different than typical negotiations in which all the issues must be resolved in order to culminate successfully.

OSHA also required that the Committee be established in accordance with, and that it follow the requirements established by, the Federal Advisory Committee Act. The Mediated Rulemaking Committee was set up in the fashion that OSHA previously had established Advisory Committees under section 7(b) of the OSH Act. Thus, all the Committee's meetings, unlike typical labor/management negotiations, were open to the public and a record was kept and made available to the public.

Further, representation of the interests involved was mandatory; not representation of all the parties, but of all the interests. The recommendations proposed by this consensus building group were developed by representatives from labor, management, and state and federal interests.

The Committee met formally on seven occasions. The first meeting consisted of organizational activities (defining consensus, establishing agendas and topics for discussions). The subsequent meetings were used to develop consensus recommendations. The last meeting ended on May 21, 1987. In this meeting the Committee made and rendered its final recommendations on the proposed standards regulating occupational exposure to MDA in both general industry and the construction industry to the Assistant Secretary. These recommendations were published on July 16, 1987 (50 FR 26776).

OSHA based its NPRM primarily upon the recommendations made by the Committee. Furthermore, in the infrequent situations where the Committee's recommendations could not be used by OSHA in its NPRM, OSHA, as agreed, provided its rationale for this non-acceptance.

OSHA also consulted, as required by section 107 (e) of the Contract Work Hours and Safety Standards Act (40 U.S.C. 333 (e)) and 29 CFR 1912.3, with the Construction Advisory Committee concerning this proposed rule for Construction. This meeting took place on November 3, 1987. This Committee advised that OSHA adopt the recommendations made by the MDA Mediated Rulemaking Advisory Committee for the construction industry and use such as the basis for its NPRM for construction.

On May 12, 1989, OSHA published a Notice of Proposed Rulemaking (NPRM) which proposed new standards regulating occupational exposure to MDA (54 FR 20672). The comment period and the time for requesting a hearing was extended to July 11, 1989. OSHA received twenty-six comments including two hearing requests; one from the A.O. Smith Co. and the other from United Technologies. Accordingly, pursuant to Section 6(b)(3) of the OSH Act, OSHA held hearings on the proposal on March 20 and 21, 1990. In response to the Notice of Hearing published on January 22, 1990 (55 FR 2101), OSHA received eleven comments and twelve Notices of Intention to Appear (NOIA) indicating the participants at the hearing. Interestingly, neither party who had requested the hearing filed a NOIA or participated at the hearing in any way. During the two day hearing, the Administrative Law Judge admitted twelve exhibits and established post-hearing comment periods that ran until May 23, 1990. OSHA has received eight timely post-hearing comments. The hearing record was certified by the Administrative Law Judge on October 10, 1990.

The final standard, like the proposed rule, is based primarily on the recommendations made by the MDA Mediated Rulemaking Committee. In those few instances where OSHA has amended the proposal and established different requirements in the final standard, these changes have been noted.

[57 FR 35630, Aug. 10, 1992]

Regulations (Preambles to Final Rules) - Table of Contents Regulations (Preambles to Final Rules) - Table of Contents