Published on
The Baltimore Sun

Foes Say Bush Plan Would Create 'Debating Society Over Science'

Health, environmental rules could be buried in peer reviews, critics fear

David Kohn

On its face, the idea sounds utterly unassailable: Who would oppose a government rule to increase expert discussion of key scientific research?

But a new Bush administration proposal to increase peer review for many scientific studies has alarmed public health and environmental groups, as well as many scientists.

They call it a back-door attempt to stifle new health and environmental regulations by burying them under mountains of discussion and analysis. Critics contend the process is also designed to produce conclusions slanted toward industry.

Critics say the new rules could be used to sidetrack research in such areas as climate change, air pollution and the effects of chemicals on children's health.

It's an incredibly terrible proposal. It will ossify the entire regulatory system. This would stop virtually all environmental and public health regulation.
- David Michaels, a professor of occupational and environmental health at George Washington University
The proposal, scheduled to take effect early next year, would require all government agencies to set up a formal, external "peer review" for any scientific study that could affect major federal regulations or "important public policies." Advocates say the plan will reduce bias in government science and regulation.

The peer review process, routinely employed by academic journals and some government agencies, invites knowledgeable scientists to comment on research findings to confirm their credibility. But the administration proposal would expand peer review far beyond current boundaries, critics say.

"It's an incredibly terrible proposal. It will ossify the entire regulatory system. This would stop virtually all environmental and public health regulation," said David Michaels, a professor of occupational and environmental health at George Washington University.

In a statement released Monday, seven Congress members called the proposal "a wolf in sheep's clothing" that would "hamper ... federal agencies' ability to make, use and disseminate good science."

Last month, the generally staid American Public Health Association also issued a statement criticizing the plan.

The proposal was drafted in late summer by the Office of Information and Regulatory Affairs, under the Office of Management and Budget, which oversees all federal regulation.

In an e-mail response to The Sun's request for comment, OIRA Administrator John D. Graham wrote: "OMB believes that peer review will improve the competence and credibility of agency science. We are open to suggestions on how to make peer review more objective and workable."

A spokesman said the OMB may consider critics' concerns in formulating the final rules.

Bill Kovacs, vice president of the U.S. Chamber of Commerce and a defender of the plan, said: "I think it's a great start. Government has been very inconsistent about peer review. The system as it stands now is a dark cave."

For example, he said, the Environmental Protection Agency has applied "faulty peer review" in crafting regulations for endocrine disruptors, widely used chemicals that may be hazardous to humans and animals.

But critics accuse the OMB of solving a problem that doesn't exist. "They haven't shown that the government produces bad science. Where is the evidence?" asked University of Kansas law professor Sidney Shapiro, an expert on federal regulation.

He and others argue that the Bush plan seems designed to gum up the process of converting scientific knowledge into regulation by trapping legitimate studies in a limbo of time-consuming evaluation.

"You'll create a debating society over the science. That's good if you don't want anything to happen," Shapiro said.

By creating the appearance of legitimate scientific debate where none exists, the plan will hinder health and environmental regulation, critics argue. "It's a system that lends itself to manufacturing uncertainty," said Michaels, a former assistant secretary at the Department of Energy. "Because you can always argue over science."

Even if the new rules aren't designed to obstruct regulation, they will waste time and money, said Thomas Louis, a biostatistician at the Johns Hopkins Bloomberg School of Public Health. "In many cases, it's going to cause a lot of unnecessary work," he said.

Despite the proposal's bureaucratic dreariness - its title is "Proposed Bulletin on Peer Review and Information Quality" - opponents say it could have a big impact on regulation.

"Ten years from now we will likely look back and see several major health issues that have been delayed for years," said University of Texas law professor Wendy Wagner.

Wagner says the plan would create review panels slanted toward industry. The proposal disqualifies as reviewers any scientists receiving funds from the same agency for any purpose. At the same time, it generally allows review by industry researchers.

"It puts the fox in charge of the chicken coop," said University of Maryland law professor Rena Steinzor, director of the school's Environmental Law Clinic.

The proposal's expression of concern about bias among government scientists baffled many at a recent National Academy of Science forum. "There is as a lot of accountability with public science. The area where there is no accountability is industry science," Shapiro said.

The proposal favors industry in other ways, critics argue. For example, it exempts from peer review so-called "permit applications," such as a chemical company's request for permission to sell a new pesticide.

"If you want to build a dam, or dump a chemical ... you evidently don't need to have peer-reviewed science," said Alan Morrison, a lawyer for Public Citizen, a nonprofit public interest organization.

He said he is also concerned that the proposal's broad scope - it covers any research deemed "relevant to an administration policy priority" - gives the OMB free rein to demand peer review of any study it chooses.

But peer review supporters say that the high cost of some health and environmental rules makes it prudent to get additional opinions. "When industry spends $1 billion on a rule, you have to make sure it's right," said Jim Tozzi, director of the Center For Regulatory Effectiveness, an industry-financed think tank.

But as a political agency, the OMB has neither the expertise nor the objectivity to make these scientific decisions, said Dr. Georges Benjamin, president of the American Public Health Association.

"There's a huge firewall between politics and science. That's something we need to maintain," said Benjamin, a former Maryland health secretary.

The proposal does allow the OMB to waive peer review in case of "imminent health hazard." But the agency shouldn't have this authority in the first place, said Michael Taylor, a former deputy commissioner at the FDA and now a fellow at Resources for the Future, a nonpartisan think tank.

"We should leave it to public health agencies to decide when the science is sufficient to take public health action," he said. "That's not OMB's job."

Opponents also argue that many federal agencies, including the EPA and the Food and Drug Administration, already use peer review extensively. Some current government officials agreed and said that because their agencies do reviews, the new rules will add little extra work.

"This shouldn't dramatically affect what we're doing," said EPA science adviser Paul Gilman.

But some former federal officials are skeptical. Michaels points to his experience with beryllium, a cancer-causing chemical used to make nuclear weapons. At the Department of Energy, he supervised rule changes that reduced the beryllium exposure allowed for nuclear industry workers. The process took several years and included safeguards to ensure scientific accuracy, he said.

The peer review plan "would have added nothing to that," Michaels said. "It would have only added more time and expense, and as a result caused more disease by delaying regulation."

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