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Plan to peer-review rules draws criticism

Fearing the process could become politicized, a number of leading researchers are mobilizing against a Bush administration plan to require peer-review before any health and environmental regulations are approved.
/ Source: a href="" linktype="External" resizable="true" status="true" scrollbars="true">The Washington Post</a

A number of leading researchers are mobilizing against a Bush administration plan that would require new health and environmental regulations to rely more solidly on science that has been peer-reviewed -- an awkward situation in which scientists find themselves arguing against one of the universally accepted gold standards of good science.

The administration proposal, which is open for comment from federal agencies through Friday and could take effect in the next few months, would block the adoption of new federal regulations unless the science being used to justify them passes muster with a centralized peer review process that would be overseen by the White House Office of Management and Budget.

Administration officials say the approach reflects President Bush's commitment to "sound science."

But a number of scientific organizations, citizen advocacy groups and even a cadre of former government regulators see a more sinister motivation: an effort to inject White House politics into the world of science and to use the uncertainty that inevitably surrounds science as an excuse to delay new rules that could cost regulated industries millions of dollars.

"The way it's structured it allows for the political process to second-guess the experts," said Georges Benjamin, executive director of the 50,000-member American Public Health Association, one of many groups that have spoken against the proposal.

New layer of review
The escalating debate over the OMB effort is the latest in a series of recent battles involving claims of politicization of science under Bush. In areas including embryo cell research, contraception and global warming, scientists in the past year have increasingly accused the White House of undercutting the federal scientific enterprise to please religious conservatives and corporate constituents.

At issue this time is a proposed rule -- technically a "bulletin," an OMB term for legally binding language meant to guide federal agency actions -- that would require a new layer of OMB-approved peer review of "any scientific or technical study that is relevant to regulatory policy."

John Graham, OMB chief of regulatory affairs and a prime architect of the administration proposal, said: "Peer review in its many forms can be used to increase the technical quality and credibility of regulatory science . . .  protects science-based rulemakings from political criticism and litigation."

Scientists across the board say they agree with that. But because peer review can also be subject to peer pressure, the question is who will do it, and under whose control.

Under the current system, individual agencies typically invite outside experts to review the accuracy of their science and the scientific information they offer -- whether it is the health effects of diesel exhaust, industry injury rates, or details about the dangers of eating beef that has been mechanically scraped from the spinal cords of mad cows.

The proposed change would usurp much of that independence. It lays out specific rules regarding who can sit on peer review panels -- rules that, to critics' dismay, explicitly discourage the participation of academic experts who have received agency grants but offer no equivalent warnings against experts with connections to industry. And it grants the executive branch final say as to whether the peer review process was acceptable.

The proposal demands an even higher level of OMB-approved scrutiny for "especially significant regulatory information," a term defined in part as any information relevant to an "administration policy priority" -- a concept that William Schlesinger finds "alarming."

The agencies implementing the plan -- the OMB and the Office of Science and Technology Policy (OSTP) -- "are fundamentally political entities," Schlesinger, president of the Ecological Society of America, which represents 8,000 scientists in academia, government and industry, wrote in a recent letter to the OMB. "It is critical that barriers between federal science and politics remain in place. These guidelines appear to weaken that vital divide."

Expect delays?
A separate concern is that the proposed process would create long delays. After all, experts said, for all its elegant capacity to discern fact from fiction, science rarely provides definitive answers. And regulations in search of certainty may wait forever.

 "This is an attempt at paralysis by analysis," said Joan Claybrook, president of Public Citizen, a government watchdog group that has also questioned the legal basis of the OMB proposal. Much of the budget agency's claim to authority over peer review comes from the Information Quality Law -- a few lines of text slipped into the 2001 Treasury appropriations bill that was never subject to congressional debate.

"This is a huge attack on the health and safety regulatory process," Claybrook said.

Regulatory delays could prove deadly in the event of a public health emergency, some doctors and scientists said. In recent years, for example, the Food and Drug Administration and the Agriculture Department have had to act quickly to stop clinical trials in which medicines were found to be causing harm or to announce that certain foods such as green onions or tainted beef should be avoided or recalled.

"We see no public benefit from mandating an additional layer of OMB interposition, peer review and public comments that, at best, would have delayed these announcements for untold months," representatives from the Association of American Medical Colleges and the Federation of American Societies for Experimental Biology wrote in comments to the OMB.

An administration official, speaking on the condition of anonymity, said a centralized system of peer review is needed because some agencies have no such procedures in place or have weak peer review rules. And the proposal would allow regulators to skip the new layers of review in emergencies, the official said, if the OMB grants a waiver.

Too much distrust?
Fred Anderson, a Washington lawyer and a member of a National Academy of Sciences panel that sponsored a November workshop focusing on the OMB proposal, said scientists are overly distrustful of the White House and the OMB.

"They are sophisticated citizens and they know OMB is powerful and they're concerned about how that power is wielded," said Anderson, who with co-counsel Geraldine Edens submitted comments to the OMB generally appreciative of the proposal. "It goes back to [John D.] Ehrlichman and Haldeman. But that was then and this is now."

Not everyone agrees, though, that White House efforts at obfuscation have been wholly relegated to history. Some cited an August 2003 report by the Environmental Protection Agency's inspector general, which concluded that EPA's 2001 statement that the air around the recently collapsed World Trade Center was safe to breathe was not backed up by actual data but was the result of the White House Council on Environmental Quality having "convinced EPA to add reassuring statements and delete cautionary ones."

Industry vs. former regulators
Of the nearly 200 public comments received by the OMB, several call for even more sweeping changes. But the political dividing lines between supportive letters and others is clear. Supporters include the National Association of Manufacturers, the National Petrochemical and Refiners Association, Ford Motor Co., the American Chemistry Council, the National Stone, Sand and Gravel Association (whose members include regulated mining concerns), and Syngenta, a pesticide company that has been in a public struggle over data suggesting that one of its products may be responsible for major declines in frog populations.

Among those filing criticisms is a group of 20 former federal officials, including prominent former regulators from the administrations of Richard Nixon, Gerald Ford, Jimmy Carter, George H.W. Bush and Bill Clinton. Among them are former labor secretary Robert B. Reich; former EPA administrators Russell Train and Carol M. Browner; heads of the Occupational Safety and Health Administration under Carter and the elder Bush; and Neal Lane, who was director of the National Science Foundation under Clinton and head of the White House Office of Science and Technology Policy.

Their letter urges the OMB to withdraw its proposal.

One interesting question raised by the new debate, experts said, is whether peer review standards for public policy should be stiffer or more lax than those applied to the publication of results in journals.

An administration official said it makes sense to raise the bar of proof when a rule is going to affect consumers, workers and businesses. By contrast, Harvard science professor Sheila Jasanoff wrote to the OMB that although research science seeks absolute truths, regulatory science should realistically settle for "serviceable truths."