NAS Asks Affected Federal Agencies to Opine on OMB's Proposed Risk Assessment Bulletin

25 Jul 2006 in Regulatory Science, Information Quality, Peer Review

On June 28, staff of the National Academy of Sciences panel charged with reviewing OMB's proposed risk assessment guidance sent OMB staff a letter "regarding questions from the NRC Committee to Review the OMB Risk Assessment Bulletin for the federal agencies." The letter apparently included a list of questions that committee members wanted affected agencies to address.

NAS posted a reference to to this letter on the project web site but did not post a copy of the letter iitself. Our request to OMB for a copy of the letter was denied, so today we submitted a formal request for it under the Freedom of Information Act.

Neutral Source has obtained what we believe to be an accurate deception of the attachment.

Here is the list of questions posed to the agencies by NAS, as reported to Neutral Source:

Questions for All Agencies Potentially Affected by the OMB Bulletin

• Please provide a brief overview of your current risk assessment practices. Specifically, do you conduct probabilistic risk assessment? Is there a common approach to both risk assessments and uncertainty analysis? How do you currently address uncertainty and variability in your agency's risk assessments?
• Please identify any substantial scientific or technical challenges that you may encounter when conducting risk assessments for your agency.
• What is your current definition of risk assessment, and what types of products are covered by that definition?
• About how long (that is, from initiation of the risk assessment to delivery to the regulatory decision maker) does it take to produce the various types of risk assessments?
• Questions about OMB’s definition of risk assessment and applicability:
  • Using the definition of risk assessment described in the OMB Bulletin, are there work products that would now be considered risk assessments that were not previously considered risk assessments? If so, what are they?
• Questions about type of risk assessment (tiered structure):
  • In your agency, is there currently a clear demarcation between risk
    assessments used for regulatory analysis and those not used for regulatory analysis? Is this clear at the outset of the risk assessment?
  • In your agency, is there currently a clear demarcation between
    "influential risk assessment" used for regulatory purposes and other risk assessments used for regulatory purposes? Is this clear at the outset of the risk assessment?
• Questions about impact of the Bulletin on agency risk assessment practices:
  • If applicable, please specify provisions in the Bulletin that can be expected to have a substantial positive effect on the quality, conduct, and use of risk assessments undertaken by your agency.
  • If applicable, please specify provisions in the Bulletin that can be expected to have a substantial negative effect on the quality, conduct, and use of risk assessments undertaken by your agency.
  • If your agency followed the procedures described in the Bulletin, would it affect the time course for production of the risk assessment (that is, the time required from initiation of the risk assessment to delivery to the regulatory decision maker)? If so, please explain why?
  • One of the Bulletin’s reporting standards states the need to be scientifically objective by “giving weight to both positive and negative studies in light of each study’s technical quality.” Please give an example of how this would be implemented by your agency or department.
• Does your agency use risk assessments conducted by external groups? Would it be helpful to you if risk assessments submitted to your agency by external groups, such as consultants and private industry, met the requirements proposed in the OMB Bulletin?

Additional Questions for Specific Agencies

DOE

• What are DOE’s current overall challenges regarding risk assessment? Specifically, please address DOE sites that have to be remediated (e.g., Hanford); DOE facilities (e.g., research and test reactors and processing plants); special projects (e.g., Yucca Mountain); and other sites (e.g., Pantex). How will the OMB Bulletin impact the quality, conduct, and use of risk assessments in these cases?

EPA

• Regarding pesticides specifically, what risk-assessment activities will be covered by the Bulletin and what risk-assessment activities will be exempted?
• Does EPA have any examples of the application of the 1996 requirements of the Safe Drinking Water Act, as described on page 13 of the Bulletin? Can any examples be provided to the committee? If none are available, can EPA provide an explanation?
• Does EPA have a working definition of “expected risk” or “central estimate”? The agency indicated in its 1986 cancer guidelines
  (51 FR 33992-34003) that central estimates of low-dose risk, based on “best fit” of the observed dose-response relationship, were meaningless -- that “fit” in the high-dose region provided no information about “best fit” in the region of extrapolation. The newer cancer guidelines appear to adopt the same thinking. Has the Agency changed its view on this point? If so, why?
  

FDA

• Dr. Galson indicated at the public meeting that there were problems with the application of OMB requirements to certain types of assessments. Can FDA suggest specific language to exclude those problematic assessments from OMB requirements, rather than just offering examples of those assessments? In other words, how would FDA describe in general terms the types of assessments it would like to see excluded?

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