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  • ACOEM Comments on Proposed Rulemaking RIN 1290-AA23 U.S. Department of Labor Requirements for DOL Agencies’ Assessment of Occupational Health Risks

    The American College of Occupational and Environmental Medicine (ACOEM) represents more than 5,000 physicians and other health care professionals specializing in the field of occupational and environmental medicine. Founded in 1916, ACOEM is the nation's largest medical society dedicated to promoting the health of workers through preventive medicine, clinical care, disability management, research, and education.  

    ACOEM and its members have worked closely with the Department of Labor, the Occupational Safety and Health Administration (OSHA), and the Mine Safety and Health Administration (MSHA) to ensure the optimal health and safety of workers and workplaces. 

    ACOEM is pleased to submit the following comments to the Department and we express our gratitude to the Secretary and Department staff for the opportunity to participate in this important rulemaking process.   

    ACOEM has long been committed to scientific integrity and the use of the best available science.  ACOEM further believes that evidence-based science should be the underpinning of any rulemaking that impacts worker health and safety.  Accordingly, ACOEM supports the Department in its clear adoption of the “best available scientific data and practices … the latest available scientific data in the field.” 

    ACOEM also supports the Department’s initiative to make available to the public in a timely way all documents relevant to occupational health rulemaking.  In so doing, the Department would effectively respond to historical concerns (whether true or not) that OSHA and MSHA have tended to undertake rulemaking in an atmosphere of secrecy.  Increased transparency and openness of Department rulemaking can only lead to improvements in the health and safety of American workers.   

    Notwithstanding our support in principle for the generic elements of the Proposed Rule, we have specific concerns about its implementation.  Of particular concern is the likelihood that implementation will delay future rulemaking.  With respect to the requirement for an ANPRM, the Proposal states:

    “The Department expects that the publication of the ANPRM, collection of public comments, and review will occur simultaneously with the ordinary development of the standard in order to ensure that the rulemaking process is not delayed or slowed.”  [73 FR 50914]

    It seems almost certain that efforts required to review, critique and integrate the additional information submitted in response to an ANPRM will necessarily lead to delays and slowing.  Our concern is not just that such delays would occur, but that they would be superimposed on a process that under normal conditions seems at times to move at a glacial pace.  

    Consider for example the last three standards issued by OSHA (Butadiene; Methylene Chloride; and, Hexavalent Chromium) which were specifically cited as examples in the Proposal because DOL had issued an ANPRM for each one.1 It is striking to consider the timelines that distinguished those three rules:


    ANPRM published 05/15/1984 (49 FR 20524)
    ANPRM published 10/01/1986 (51 FR 35003)
    Final rule published 11/04/1996 (61 FR 56746)
    Elapsed time12 years, 5 months, 20 days

    Methylene Chloride:

    ANPR M published 11/24/1986 (51 FR 42257)
    Final rule published 01/10/1997 (62 FR 1493)
    Elapsed time10 years, 1 month, 17 days 

    Hexavalent Chromium:

    ANPRM published 08/22/2002 (67 FR 54389)
    Final rule published 02/28/2006 (71 FR 10100)
    Elapsed time3 years, 6 months, 6 days2 

    It seems clear that for more than two decades, the OSHA regulatory process has proceeded slowly.  That slow pace has needlessly permitted numerous workers to be exposed for years to specific industrial chemicals at levels that OSHA ultimately deemed unacceptable.  

    ACOEM objects to such lack of timeliness in the promulgation of occupational health regulations, a lack that would be of concern without regard to the Proposed Rulemaking.  The current Proposal, however, raises concerns of further slowing. 

    We strongly urge as part of this rulemaking, and in the interests of compiling truly “best practices” for future risk assessments, that there be developed specific timelines to guide the process and set time limits for the various stages of the risk assessment and rulemaking processes.  Such timelines could be adaptive to evolving scientific understanding, while also ensuring that reasonable limits were imposed on the deliberative and political aspects of rulemaking. 

    ACOEM also urges the Department to provide greater detail about the definitions and content of its standard “defaults”.3 The Proposal states:

    “The Department strives to obtain the best available evidence in all key assumptions and defaults underlying its risk assessments, but the use of assumptions is invariably necessary if information is lacking.” [73 FR 50913]

    It is reassuring that the Department uses “best available evidence” in setting defaults, but that statement is insufficient.  While the use of defaults assumptions should be adaptive, there is also important need to ensure consistency.  This particular concern was emphasized recently by the National Research Council Committee to Review the OMB Risk Assessment Bulletin, which stressed the need to avoid “case-by-case manipulations of risk assessments”.4

    To achieve the stated goals of openness and transparency in its regulatory process and occupational health risk assessments, ACOEM urges the Department to articulate its standard defaults, along with procedural guidelines to allow departure from those defaults when appropriate.  Moreover, the specific determination of individual defaults should be subject to public comment and scientific review. 

    Finally, as discussed in the Proposed Rulemaking and as recognized by the Supreme Court, Congress ranked the health of workers above all other concerns in the regulatory process: 

    “The Court explained that, ‘Congress itself defined the basic relationship between costs and benefits, by placing the ‘benefit’ of worker health above all other considerations’.”  [73 FR 50913]

    ACOEM shares that view.  Accordingly, we urge the Department to modify its Proposal to make explicit the default assumptions that underlie many critical aspects of occupational health risk assessments and to ensure that future rulemaking proceeds according to explicit timelines. 

    1 In fact, there was no ANPRM for Hexavalent Chromium.  Instead, DOL published a Request for Information. 

    2 A compressed schedule for this rulemaking was established by order of the U.S. Court of Appeals for the Third Circuit (See Public Citizen Health Research Group v. Chao, 314 F.3d 143(3rd Cir. 2002)).

    3 In speaking of “defaults”, ACOEM specifically refers to defaults that impact the process of risk characterization (e.g., “default uncertainty factors”) , and others that impact dose-response and exposure assessments (e.g., duration of the ”default” workday, workweek and work-life).

    4 Committee to Review the OMB Risk Assessment Bulletin, National Research Council: Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget.  Washington, DC: National Academy Press, 2007; p. 18.