Following EPA criticism

OMB Excludes Economic Impacts From Revised Scientific Peer Review Policy

The White House Office of Management and Budget (OMB) has excluded economic impact studies of regulations from a revised draft policy on scientific peer review requirements that EPA officials have feared could slow the rulemaking process and delay environmental protections.

While OMB has made a number of concessions to EPA in the revised policy, the document still reflects the interests of industry by allowing parties to insist that the scientific basis of regulatory or policy decisions be subject to an extensive and lengthy peer review process, sources say. It would also allow outside parties to insert information in the administrative record that could be used as ammunition in legal or other challenges to agency rules. The revised approach may provide industry with the opportunity to file early data quality challenges to agency decisions by requiring the government to periodically publish its upcoming plans for allowing scientists outside the government to review the validity of data used by regulators in specific policy decisions.

In response to public and federal agency comments filed on its Proposed Bulletin on Information Quality and Peer Review, OMB on April 15 issued a revised proposal that specific cost-benefit studies which accompany agency regulatory proposals -- known as Regulatory Impact Analyses (RIAs) -- will not be subject to the new requirements. However, OMB says the models and data underlying RIAs will still be covered.

EPA economists and regulators raised concerns about the original bulletin issued in August 2003 by arguing that peer reviewing individual RIA's would be redundant and unnecessarily delay new protections.  “We're pleased the proposal was modified. Now it basically codifies current practice,” according to one EPA economist.

However, OMB has maintained a proposed requirement that agencies relying on key scientific assessments in rulemakings enter into the administrative record how they complied both with the OMB bulletin and the Information Quality Guidelines, established under a 2001 law that allows outside parties to challenge the validity of information released by the federal government. “This creates a record that goes into the rulemaking indicating whether an agency has curtailed or shortchanged the required scrutiny” and could prevent “agencies from springing a scientific document on stakeholders,” according to an industry attorney. The source explains that the record could be useful in convincing judges that some requirements for  developing a rule were not adequately addressed by an agency.

But OMB says the revised requirements are not intended to create any new legal rights of actions against agencies.

OMB released its re-proposed bulletin, which is subject to an additional 30-day comment period, along with its response to the first round of 187 agency and public comments. In general, the proposed requirements are intended to ensure the expertise and independence of peer reviewers, including the opportunity for public comment and mandating that agencies document their response to evaluations of the scientific basis of policy decisions.

Some observers say the Bush administration has narrowed the scope of the requirements in response to criticism from leading scientific organizations that the draft policy was overly prescriptive and even counterproductive. “OMB has made an overwhelming effort to be responsive” and has sought out meetings with the National Academy of Sciences, medical schools and research universities to modify the plan so as not to negatively impact their activities, according to one science policy expert.

A source with the American Association of Medical Colleges (AAMC) says OMB has “backed off micromanaging the information quality process.” But AAMC wants to ensure that “agencies retain their discretion over handling highly influential scientific information in case dramatic new medical findings” need to be released immediately to protect public health, the source says.

Information now exempt from the requirements include clinical drug trials, non-precedent setting agency adjudications or permit proceedings, National Academy of Science reports, and documents related to national security.

OMB is proposing to reserve the highest level of review for “highly influential” scientific findings that are expected to have a minimum $500 million annual impact on businesses by discouraging the continued use of certain products or through new regulatory controls. Previously, OMB had set the threshold for the more stringent peer review requirements at $100 million. The revised policy is also limited to “novel, complex or precedent setting approaches or generate significant interagency interest,” according to the latest bulletin.

In addition, each federal agency would now be required to document its peer review plans for scientific documents every six months and post it on the agency's website, similar to the regulatory plans -- or unified agenda -- agencies now publish in the Federal Register.

“This proposal is really important because it provides early targets for data quality challenges,” according to a consultant with the Center for Regulatory Effectiveness, an industry-funded group. The public notification requirement will allow outside parties to prepare sooner for potential challenges to upcoming EPA peer review plans or file data quality challenges.

The new requirements are an effort to “promote the appropriate use of peer review in order to enhance the technical quality and credibility of information disseminated by federal agencies,” according to OMB.

But environmentalists are continuing to raise concerns about the bulletin, arguing that the scientific community itself should establish accepted standards for peer reviews, rather than government policy agencies.

“OMB is still stuck in the misconception that what is good for science is good for government and that just doesn't follow,” according to a source with the Center for Progressive Regulation.

Date: April 16, 2004

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