NRC BLASTS 'FLAWED' GUIDELINES

Report recommends that the White House withdraw its federal RISK ASSESSMENT POLICY

CHERYL HOGUE, C&EN WASHINGTON

IN AN UNUSUAL and sustained casti-gation, the National Research Council minces no words in a report issued earlier this month. NRC, an arm of the National Academies, says the Bush Administration's draft guidelines for risk assessment across the federal government are "fundamen­tally flawed" and should be scrapped.

The report is "a stringent rebuke" to the Bush Administration, says Rep. Henry A. Waxman (D-Calif.), chairman of the House Oversight & Government Reform Committee.

"NRC generally does not write a report that is so scathing," says Rick Melberth, di­rector of federal regulatory policy at OMB Watch. That watchdog group tracks activi­ties of the White House Office of Manage­ment & Budget (OMB), which issued the draft guidelines a year ago.

"Myjaw dropped," says David Michaels, research professor and associate chairman of the department of environmental and occupational health at George Washington University. "It's powerful."

Members of the NRC committee that wrote the report expected initially they would only have to provide suggestions for changing the draft guidelines, says John F. Ahearne, who chaired the panel and is director of the ethics program at Sigma Xi, a scientific research society. After delving into the issues, however, they realized the directive would not help the cause of "getting high-quality risk as­sessments," Ahearne says. The committee members determined unanimously that for scientific and technical reasons, OMB needs to withdraw the entire proposal, he says.

In light of the NRC report and the com­ments it received from federal agencies, OMB is planning to recast the guidelines, says Steven D. Aitken, acting administrator of OMB's Office of Information & Regu­latory Affairs, the office that issued the draft. OMB is pleased that the NRC report endorsed the draft's goal of improving the

quality and objectivity of federal risk as­sessments, Aitken adds.

When it released the draft guidelines in January 2006, OMB described them as "clear, minimum standards for the scientific quality of federal agency risk as­sessments" (C&EN, Jan. 16,2006, page 6). Industry groups, including the American Chemistry Council (ACC), endorsed the di­rective because they believed the guidelines would lead to improvements in the risk as­sessments done by regulatory agencies.

Safety, health, and environmental ac­tivist organizations, on the other hand, attacked the guidance document, saying it would slow regulation—especially controls on chemicals in the environment—and give industry more chances to attack the scientific assessments that support regula­tors' decisions.

A variety of federal agencies, including those involved in regulation and those that only conduct research, agreed that the guidelines would snarl government activi­ties (C&EN, June 5,2006, page 45). Federal

officials provided the NRC committee with numerous examples of how the pro­posed guidelines might tie up their actions. Among them was the concern that the guidelines would deter the Food & Drug Administration from informing the public about serious adverse health effects from a prescription drug. Another issue was that the rules could create high hurdles for the National Institutes of Health to clear before it could provide timely scientific research results to other federal agencies or to the public.

According to Michaels, the overarching themes of the NRC report are that govern­ment agencies should develop their own risk assessment policies on the basis of their resources and needs and that it is inappropriate for the White House to try to impose government-wide guidelines on risk assessments.

"In view of the diversity of risk assess­ment responsibilities and proficiencies in the federal government, it would be dif­ficult, if not impossible, to produce a single detailed technical guidance document that would be applicable to all federal agen­cies," the report says.

THE CENTER for Progressive Reform is a nonprofit research and educational or­ganization that opposes the guidelines. It calls the NRC report "a condemnation of OMB's effort to take risk assessment out of the hands of scientists and public health experts and put it in the hands of its econo­mists, in an effort to rig the outcome so as to weaken health and safety protections."

In addition to identifying numerous technical and scientific problems with the OMB plan, the NRC report says the guidelines have a high potential for actually harming the practice of risk assessment in the federal government. Some aspects of the directive could be beneficial, the report acknowledges, but "the costs—in terms of staff resources, timeliness of completing

risk assessment, and other factors—are likely to be substan­tial," it states.

OMB is the White House regulatory gatekeeper that pores over the economic analyses done by agencies and used to justify every major federal rule. The report advises OMB

OMISSION NRC criticizes the White House's guidelines for federal risk assessment in part because they would exclude information provided by companies for drug approvals.

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GOVERNMENT & POLICY

to take a dose of its own medicine. For example, OMB failed to identify the costs of implementing its guidelines and does not know which agencies lack the ability or resources to meet the proposed risk as­sessment standards, NRC says. The lack of this infor­mation to support the OMB directive was "surprising," it adds.

Despite the likelihood that implementation of the guidelines would be expen­sive, the White House gave no indication that it would ask Congress for extra mon­ey to improve federal risk assessments, the report con­tinues. If the guidelines were implemented without new funding, "fewer risk assess- Ahearne ments would be done, fewer risks would be identified (and the extent of the risks understood), and fewer solutions would be proposed for problems that need consideration," the NRC report says.

"Many deficiencies in the technical qual­

ity of the current risk assessments and risk assessment programs can be traced not to inadequate guidance but to inadequate re­sources," including not enough dollars and staffers to carry out these analyses prop­

erly, the report notes. 5 Rep. John D.Dingell o (D-Mich.), chairman of the % House Energy & Commerce 2 Committee, says, "OMB p should follow NRC'srec-* ommendation and abandon

its costly requirement for superfluous analysis that ig­nores the specific statutory directives Congress gave the agencies."

ACC, even though it sup­ported the guidelines, says it is encouraged by the part of the NRC report saying "that there is room for im­

provement in risk assessment practices in the federal government and that additional guidance would help."

"Although significant advances have been made over the past 10 to 15 years in

the state of the science of risk assessment, the routine use of these advanced risk as­sessment approaches by federal agencies has not kept pace," says Richard A. Becker, ACC's senior toxicologist. "Agencies need to bring their practices up-to-date to assure an objective portrayal of potential risks."

NRC also criticizes OMB's draft bulletin for conveying "the impression that risk assessments can and should achieve total objectivity." This is a misguided impres­sion to convey, the report says, because risk assessments are usually done when there are some scientific data still missing and thus have to include assumptions and judg­ments. An example is the assumption that the risk of cancer increases linearly with more exposure to a carcinogen.

The report also points out a number of other issues OMB failed to address in its risk assessment guidelines. The directive is vague on the need for assumptions and default values, which are based on expert judgment and which risk assessors rely on when they lack scientific data. For instance, regulators without chemical exposure information may assume that a person is

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outside an industrial facility continuously for 70 years, breathing the plant's emis­sions. OMB's lack of a discussion about de­fault values and assumptions was a serious deficiency in the guidelines, says Joseph V. Rodericks, founding principal of Environ International, a technical consulting firm. Rodericks served on the NRC panel that produced the report.

The guidelines also fail to discuss the need for definitive criteria that spell out when risk assessors can use numbers other than default values. 'Without explicit and clear directions on such matters, agency risk assessments are more susceptible to being manipulated to achieve a predeter­mined result," the report says.

Another omission from the guidelines

could have a major impact on how children, the elderly, the poor, or minority com­munities are protected through federal regulations. OMB's draft directive empha­sizes that risk assessments should focus on "central estimates," that is, the most likely chances of harm to the average person from a risk.

This means those making regulatory decisions could be deprived of information on risks—such as health problems from ex­posure to chemicals—to the most vulner­able people in a population, which might include children, the elderly, or "environ­mental-justice subpopulations"—poor or minority communities living in particularly pollution-plagued areas—the NRC report says. The most vulnerable groups, the report explains, "almost by definition, lie in the tails of the probability distribution" and might be underrepresented in a central estimate.

Rep. Albert Wynn (D-Md.), chairman of the House Energy & Commerce Sub­committee on Environment & Hazardous Materials, says, "I am deeply troubled by the effect that OMB's proposed risk assess­ment analysis would have on our most vul­nerable and disadvantaged constituents."

ANOTHER ISSUE was that OMB's draft would have excluded from its own guide­lines a broad array of risk assessments that are submitted to federal regulators by companies seeking product approvals or registrations, notably for pharmaceuticals and pesticides. Excluding this informa­tion from the guidelines, coverage "is not consistent with the overarching objective of seeking higher quality risk assessments," NRC says. It adds that the onus should be on outside parties and not on a govern­ment agency to ensure that the informa­tion they submit to regulators conforms to any federal risk assessment guidelines.

In place of the guidelines, the report says, OMB should issue a new document that is limited to the goals and general prin­ciples of risk assessment. This document should direct each federal agency to devel­op its own peer-reviewed technical guide­lines on risk assessment that are consistent with the agency's statutory mandates and missions, the NRC report says.

This new document, Ahearne says, "should draw on the risk assessment exper­tise that exists in federal agencies and the organizations that advise them."

NRC's report is available at www.nap. edu/catalog/ii8n.html. •

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