INDUSTRY ALTERNATIVE TO OMB RISK BULLETIN DRAWS FIRE FROM ACTIVISTS

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Date: June 15, 2007 -

A proposal being offered by an industry-funded group as a replacement for a controversial White House Office of Management & Budget (OMB) risk assessment guidance facing Senate scrutiny is drawing fire from activists, who say the proposal fails to address many of their concerns about the OMB guide and would create its own implementation problems at EPA and other federal agencies.

The existing OMB guidance proposal, originally introduced for public comment in January 2006, has led to Democratic and activist criticism as well as a National Academy of Sciences (NAS) recommendation that it be withdrawn. Recently the criticism has included a May 14 letter from Sens. Jeff Bingaman (D-NM) and Joe Lieberman (I-CT), who chair the Energy and Homeland Security & Governmental Affairs committees respectively, calling on OMB Director Rob Portman not to issue the guidance -- a move in line with NAS’ January report calling it “fundamentally flawed”.

The guidance has not yet gone into effect, and OMB official Susan Dudley has signaled she does not know when a revised version will be available. Critics of the OMB proposal have said it too narrowly focuses all risk assessments on methods relevant to EPA’s environmental risk assessment process, giving other agencies and departments guidance that could be difficult to use and interpret.

Now an alternative guidance is being proposed by the Center for Regulatory Effectiveness (CRE), a deregulatory government affairs group. The proposal, which was submitted to OMB June 6, notes in its summary that NAS “recently recommended that a previous OMB guidance proposal on this topic be withdrawn and replaced by more general goals and principles. This guidance follows that . . . recommendation.” It lays out a variety of federal agency risk assessment and risk communication measures not included in the OMB version, including some that activists say will hamper EPA’s ability to perform risk assessments and promulgate useful regulations.

A CRE source says the proposal was sent to OMB “to focus peoples’ attention and get the ball rolling” because OMB does not have statutory deadlines to finalize a new risk assessment guidance and may take a long time to complete it. The proposal is available on InsideEPA.com.

The CRE proposal describes itself as stemming from a mandate in the 2000 Information Quality Act (IQA), which required OMB to develop and issue guidance to federal agencies on ensuring the quality of information agencies disseminate to the public, including its objectivity and utility. “In view of the inconsistencies among agencies on presentation of risk information, conflicts between agency risk assessment and characterization practice, and the requirement in the IQA and OMB guidelines for objectivity, OMB finds it necessary to clarify through goals and principles how the objectivity and utility requirements apply to risk information,” the CRE draft says.

The CRE guidance would mandate that risk assessments set aside a new portion of their scientific discussion to address the level of confidence assessors have in the data underlying their conclusions, a measure that activists have long charged is a way to effectively paralyze health and environmental regulations by highlighting uncertainty. The CRE proposal says such assessments should include “an expression of professional scientific judgment concerning the level of confidence that can be placed in the underlying data, the scientific understanding of the data, and the overall conclusions in the information presented.”

Further, CRE’s draft directs risk assessors not to promote a best estimate of safe exposure without clear scientific support, saying, “Single expressions or point estimates of risk shall not be presented when not supported by the scientific evidence and professional scientific judgment concerning that evidence. Expression of risk as a range must also be based on scientific evidence and professional scientific judgment concerning the scientific evidence.”

A source with OMB Watch, an activist group opposed to both the CRE and OMB versions of the risk assessment guidance, says such restrictions on setting risk levels in the absence of scientific certainty “lead to endless data collection because you never have full data. This allows OMB to say the science is too uncertain” to promote regulations that may be needed.

Dudley said in a June 8 interview with Inside EPA that she had not seen the proposal and that discussions about how to proceed with risk assessment guidance revisions have not been influenced by it.

Source: Inside EPA via InsideEPA.com

Date: June 15, 2007

Issue: Vol. 28, No. 24

INSIDEEPA-28-24-10