It is campaign season and there is a political donnybrook brewing in Washington. This fight, however, has nothing to do with the upcoming election, although the ultimate results of the election could have a major impact on the final outcome. This battle involves the Department of Labor’s proposed rule to revise the way that OSHA and MSHA conduct risk assessments to support new occupational health rules.
On one side, DOL describes this rule as an effort to streamline its agencies’ rulemaking processes and standardize their risk assessment procedures. On the other side, congressional leaders and labor advocates charge that it is simply an effort by the Bush Administration to slow down the process of enacting new health regulations. Regardless of your perspective, the dispute has significant implication for future health compliance at both OSHA and MSHA regulated facilities.
Mistrust and Suspicion
The Department of Labor issued this notice of proposed rulemaking on August 29, 2008. Entitled “Requirements for DOL Agencies’ Assessment of Occupational Health Risks,” 73 Federal Register 50909, proposed rule describes its purposes as (1) compiling “best practices related to risk assessment into a single easy-to-reference regulation” and (2) establishing consistent procedures for conducting risk assessments that “promote greater public input and awareness of the rulemakings.”
The suspicions that surround these seemingly innocuous goals are generated primarily by the universal expectation that the next administration will promulgate a myriad of health regulations that have largely been held at bay during the Bush Administration. Consequently, critics interpret this rule as an effort by the Bush Administration and industry to impede this effort.
A leaked draft of the rule that was submitted to the Office of Management and Budget in July, without notice to the public, set off a firestorm of protest from Democratic Congressional Leaders. Although, the Department of Labor pointed out at that time that it is not required to seek public comment on changes to its internal procedures for promulgating standards, House Education and Labor George Miller nonetheless responded by introducing legislation entitled “Prohibiting the Department of Labor’s Secret Rule Act,” H.R. 6660, to force the agency to discuss the proposed rule.
Key Features of the Rule
Despite these political undercurrents, it is difficult to argue that this proposal does not at least clarify a risk assessment process that has often been characterized as being based on flawed and insufficient scientific data and allowing too little time for public comment and study. The rule maintains the threshold criteria for promulgating a new health standard -- established by the Supreme Court in Industrial Union Dept. v. American Petroleum Inst. 448 U.S. 607,656(1980) – that there be a “significant risk that can be eliminated or lessened by a change in practices.” Critics argue that this threshold evaluation cannot be conducted effectively because the rule fails to define significant risk. Ultimately, that determination is left to the agency. Nonetheless, the rule does codify the best practices framework for making that determination by laying out the four components that an agency risk assessment must include and identify:
(1) Hazard Identification – Whether a substance or chemical is a health hazard;
(2) Dose-Response Assessment – Whether there is a link between exposure and an adverse health outcome;
(3) Exposure Assessment – Estimate of the exposure to substance in workplace; and
(4) Risk Characterization – Estimates the risk to workers by summarizing key findings, limitations of the data, the choice of assumptions when there is a gap in the data, inherent uncertainties in the assessment, limitations of the database and how all these factors affect the risk assessment. 73 Fed. Reg. 50915.
At first glance, this framework would not appear to be controversial. However, critics complain that there is no guidance regarding how to evaluate uncertainties, what constitutes an “adverse health outcome” and when default assumptions – assumptions used in risk assessments when there is insufficient data – can or should be used. Consequently, agencies are given to much leeway to decide what is pertinent and what is not.
Working Life Exposure and Lengthened Rulemaking
The use of default assumptions is a major flash point when it comes to the analysis of working life exposure. The proposed rule states that “[r]isk assessments shall utilize the best available scientific data in the field, including industry-by-industry evidence relating to working life exposure.” 73 Fed. Reg. 50915. This approach would replace the traditional DOL assumption of a 45-year working life which critics believe could adversely alter exposure findings.
The proposed rule also requires that agencies issue an advanced notice of proposed rulemaking, in addition to a notice of proposed rulemaking, in any health standard promulgation process. Agencies will be required in this early phase to solicit pertinent public input, relevant studies and scientific information. Critics see this feature as an attempt to add another time consuming obstacle and slow down the rulemaking process.
The comment period for this proposed rule closes on September 29, 2008. While it remains to be seen whether this rule will be implemented in its current form, one thing is certain. Regardless of this dispute over the details of risk assessment procedures, all observers are anticipating the potential for a substantial increase in health regulation rulemaking for chemicals and substances in the workplace. Regardless of your perspective on that possibility, this current battle should be watched closely because it will have a major impact on how that rulemaking process unfolds.
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