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http://www.commondreams.org/headlines03/1219-03.htm

Published on Friday, December 19, 2003 by the Baltimore Sun
http://www.sunspot.net/

Foes Say Bush Plan Would Create 'Debating Society Over Science'
Health, environmental rules could be buried in peer reviews, critics fear


by David Kohn

QUOTE:
"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


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.

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."

Copyright © 2003, The Baltimore Sun

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