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Department of Labor Submits Draft Proposed Rule on Occupational Risk Assessment to OMB for Review

Date: Aug 01, 2008

On July 7, 2008, the Department of Labor (DOL) submitted a draft Notice of Proposed Rulemaking titled "Requirements for DOL Agencies' Assessment of Occupational Health Risks" to the Office of Management and Budget (OMB) to obtain approval for publication in the Federal Register.

This rule, unlike most, is not a substantive rule governing employers. Instead, it outlines internal procedures for risk assessments conducted by DOL agencies, primarily OSHA and MSHA, in developing health standards. The draft proposal is intended to (1) create a consistent, reliable, and transparent set of procedures when conducting risk assessments, (2) outline the components that should be included in a risk assessment, and (3) provide for improved public access to rulemaking information and public participation in the rulemaking process.[1]

In large part, the preamble to the proposal summarizes current practices and requirements established by the Supreme Court decisions in Benzene and Cotton Dust,[2] the Information Quality Act (IQA),[3] Executive Order 12866,[4] and other risk assessment guidance.[5] Two features of the proposal are particularly notable.

First, the draft proposed rule would require the affected DOL agency to issue an Advanced Notice of Proposed Rulemaking (ANPRM), which would help the agency in deciding whether to proceed with a rulemaking and, if so, what approach would be most effective, before publishing a Notice of Proposed Rulemaking (NPRM), thus providing the public with an opportunity to present relevant studies and scientific information to assist with risk assessment. This would formalize the type of approach that OSHA announced for crystalline silica and preclude the affected agency from taking shortcuts in the interest of expediency. OSHA's Peer Review page states that OSHA "[a]nticipate[s] requesting written comment on [the] draft report at a time to be announced later, and subsequently holding a public meeting."[6] This DOL action would ensure that the "anticipated" public participation will consistently occur in connection with the adoption of every health standard. Given that the rules governing peer review panels preclude the participation of interested parties, we believe this opportunity for public participation at this point in the rulemaking process is critical.

This proposal parallels the approach followed by California in updating its Permissible Exposure Limits (PEL). That procedure was adopted through an advisory committee process after extensive input from industry, organized labor, public interest groups, and government agencies. Under that procedure, the risk assessment is performed by an advisory committee in open process involving all stakeholders, and then the feasibility issues are addressed by a separate Feasibility Advisory Committee, which is expected to have significant representation by affected industries. All of that occurs before the recommended proposals are sent to the Standards Board to be issued as a proposed rule.

Second, the draft proposed rule would support a more realistic measure of exposure when the data are available to overcome default assumptions. Traditionally, when adopting PELs, OSHA bases its exposure assessment on the default assumption that affected workers will continuously work in jobs with unprotected exposures at or above the PEL, 40 hours per week, 50 weeks each year, for 45 years. Under the draft proposed rule, however, agencies would be required to solicit information on the appropriate "working life model" of workers. The 40 hours per week, 50 weeks per year, 45-year "working life model" would remain the default where available data did not demonstrate that another approach was more appropriate.

DOL believes it is imperative that the "working life model" used in adopting a standard reflect "realistic estimates, based on the best available evidence, of the actual number of years that workers who spend their entire working life in a particular industry or occupation tend to work." [7] With more realistic estimates, DOL agencies can better assess relative risk and ensure that the most dangerous conditions are being addressed first.

DOL should be commended for bringing this proposal forward. It is unfortunate that the effort to streamline the regulatory agenda and the delayed publication of this proposal have created a political controversy that obscures the merits of what is being presented. In the Regulatory Agenda of November 2000, OSHA indicated that it was developing a proposal to update certain PELs, and said,

"[I]t is a high OSHA priority to establish an ongoing regular process that will allow OSHA routinely to update existing PELs and to establish limits for some currently unregulated substances. The first step in achieving this goal is to publish an air contaminants proposal for a number of substances that will establish streamlined but scientifically sound and defensible procedures for conducting risk assessments and performing feasibility analyses that will permit regular updating and review of permissible exposure limits for air contaminants."

While the delay has been unfortunate, we view this positive development as the "first step" OSHA referenced, and believe OSHA and MSHA should follow the same scientific procedures and, where practical, consider joint rulemakings for establishing risk estimates within the limits of their respective regulatory authority.

The proposal opens the door for an updating of risk assessment procedures in both DOL agencies, something that has not been seriously discussed in more than 30 years. Since that time, such efforts have focused on specific chemical substances and not on generic procedures, assumptions and models. This proposal should offer a long-needed opportunity to reach a scientific consensus on the issue.

The employer community, as well as organized labor and other interested parties, should embrace this opportunity to have this discussion. Employers should participate in what promises to be an important effort on DOL's part to streamline the rulemaking process for health standards, a process that everyone agrees has produced less than stellar results over the last 15 or more years. We encourage you to contact your trade associations and to participate in the process. We anticipate that it may be issued in August with a short 30-day comment period, and we encourage you to watch for the announcement and to participate actively in the process.

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For more information on the draft "Requirements for DOL Agencies' Assessment of Occupational Health Risks," or on OSHA's rulemaking process generally, please contact:



[1] U.S. Department of Labor, Proposed Rulemaking, Requirements for DOL Agencies' Assessment of Occupational Health Risks (2008).

[2] Industrial Union Dept. v. American Petroleum Inst., 448 U.S. 607, 614-15, 100 S. Ct. 2844 (1980); American Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490 (1981).

[3] Information Quality Act, Pub. L. No. 106-554 (2000).

[4] Executive Order 12866, 58 Fed. Reg. 51,735 (Oct. 4, 1993).

[5] Presidential/Congressional Commission on Risk Assessment and Risk Management, Framework for Environmental Health Risk Management, Final Report (1997); and U.S. Office of Management and Budget and Office of Science and Technology Policy (OSTP), Memorandum for the Heads of Executive Departments and Agencies, Updated Principles for Risk Analysis (2007).

[6] http://www.osha.gov/dsg/peer_review/peer_agenda.html

[7] U.S. Department of Labor, Proposed Rulemaking, Requirements for DOL Agencies' Assessment of Occupational Health Risks, at pgs. 18-19, (2008). Section 6(b)(5) of the OSH Act and Section 101(a)(6)(A) of the Mine Act "requires the Department to use a standard that ensures that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure that would be experienced by a hypothetical worker who is exposed to a substance for his or her entire working life." Although the statute uses the phrase "'no employee', the Department has never interpreted this language as requiring it to use the longest actual or theoretical working life it can identify or imagine."