Previously we alerted readers to proposed government-wide guidance on the conduct of health, safety and environmental risk assessment. An ad hoc National Academy of Sciences committee was established to review this proposed guidance document. The committee held its first public meeting on May 21, 2006.
The meeting began with presentations by Office of Management and Budget (OMB) staff toxicologist Nancy Beck, and John Graham, former administrator of OMB’s Office of Information and Regulatory Affairs (OIRA). Graham resigned his post shortly after publishing the proposed guidance for public comment. He is now Dean of the Pardee RAND Graduate School.
Beck’s presentation consisted of a short description of the provisions of the proposed guidance. She reiterated that the charge to the NAS panel primarily concerned scientific and technical matters on which such a panel arguably has expertise, and that OMB expected to receive the committee’s report this autumn.
Graham provided a rationale for the guidance document using three illustrations from his OMB experience:
- An instance in which risk assessment provided the government justification for taking deregulatory action (a USDA action to reopen the U.S. to imports of Canadian beef subsequent to a BSE detect in Canada)
- An instance in which risk assessment provided the government justification for taking regulatory action (EPA’s 2004 non-road diesel rule)
- An instance in which risk assessment was performed for nominally non-regulatory purposes (e.g., EPA’s Integrated Risk Information System) but which has significant indirect regulatory effects (EPA’s 2002 draft perchlorate risk assessment)
Graham used these examples to illustrate situations in which a risk assessment was needed but had not been performed (the USDA rulemaking); a risk assessment was relatively well-conducted and justified the regulatory action being taken (the EPA diesel rulemaking); and a draft risk assessment with fatal scientific flaws that were confirmed by a NAS review and which would not have occurred had the principles of the proposed guidance been followed.
The NAS panel heard presentations from the Department of Agriculture (USDA), the Department of Labor (DOL), the Environmental Protection Agency (EPA), the Department of Defense (DoD), the Department of Energy (DOE), the National Aeronautics and Space Administration (NASA), and the Department of Health and Human Services (DHHS).
All agency speakers supported the principles of the guidance. However, USDA, DOL and especially DHHS generally objected to having to comply with its provisions. NASA objected on the ground that its sophisticated risk assessment methods and procedures adhered to the principles but might not be permitted under the guidance. EPA said its existing risk assessment guidance is largely consistent with the proposed OMB guidance. DoD supported the proposed guidance and suggested that it be extended to site-specific applications that would be exempt under the current draft.
Additional presentations were delivered by various individuals and stakeholders:
- Gilbert Omenn, Professor of Medicine, Genetics and Public Health, University of Michigan Medical School
- Alan Krupnick, Senior Fellow and Director, Quality of the Environment Program, Resources for the Future
- Steven Heinig, Senior Research Fellow, Association of American Medical Colleges
- Lorenz Rhomberg, Principal, Gradient Corporation
- Judith Graham, Managing Director, Long-Range Research Initiative Team, American Chemistry Council
- Robert Schull, Director of Regulatory Policy, OMB Watch
- Jennifer Sass, Senior Scientist, Health and Environment, Natural Resources Defense Council
These presentations largely followed the interests of the stakeholders the speakers represented. Notable comments include:
- Omenn recommended that interagency review and coordination of draft risk assessments occur earlier in the regulatory development process instead of at the end.
- Krupnick supported the guidance to the extent that it would stop the longstanding practice of embedding precautionary policy judgments within risk assessment (“risk aversion bias”).
- Rhomberg admitted that fulfillment of certain provisions of the guidance would be difficult in some cases, but said that difficult or not they ought to be performed when the stakes are large.
- Schull objected to any requirement for the generation of central tendency estimates of individual risk, and to population risk estimates in general, terming these things “irrelevant information.” He also objected to the possibility that weight-of-evidence determinations might be removed from risk assessment and made an explicit risk management activity.
- Sass objected to language in the preamble that, in her view, might prevent risk assessments to be based on non-adverse effects. She also asserted that the guidance would have imposed burdensome new duties on federal agencies but exempted industry risk assessments.
All speakers who devoted attention to the preamble complained about ambiguities and inconsistencies. Opponents consistently called for OMB to perform a benefit-cost analysis showing that the benefits of adhering to the principles and provisions of the guidance outweighed the costs.