- WASHINGTON -- Under a new
proposal, the White House would decide what and when the public would be
told about an outbreak of mad cow disease, an anthrax release, a nuclear
plant accident or any other crisis.
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- The White House Office of Management and Budget is trying
to gain final control over release of emergency declarations from the federal
agencies responsible for public health, safety and the environment.
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- The OMB also wants to manage scientific and technical
evaluations - known as peer reviews - of all major government rules, plans,
proposed regulations and pronouncements.
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- Currently, each federal agency controls its emergency
notifications and peer review of its projects.
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- But the OMB says peer review policies in various agencies
vary dramatically. And a senior OMB official says his office has been ordered
by Congress to take "a greater role in evaluating what the agencies
do."
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- On Friday, a nonpartisan group of 20 former top agency
officials sent a letter to the OMB asking the White House watchdog agency
to withdraw its proposal, saying it "could damage the federal system
for protecting public health and the environment."
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- One of the signers, David Michaels, said: "It goes
beyond just having the White House involved in picking industry favorites
to evaluate government science. Under this proposal, the carefully crafted
process used by the government to notify the public of an imminent danger
is going to first have to be signed off by someone weighing the political
hazards."
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- Michaels, a former assistant secretary for environment,
safety and health at the Department of Energy, is now a research professor
at George Washington University's School of Public Health. He added: "OMB
is not a science agency. The ramifications of it attempting to insert itself
into a time-proven system of having the most knowledgeable scientists available
evaluate proposed policy or regulations is a disaster in the making."
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- In addition to Michaels, the letter is signed by two
former Environmental Protection Agency administrators, a former secretary
of labor, two former heads of the Occupational Safety and Health Administration,
a former assistant labor secretary in charge of mine safety and health,
and 13 other former senior officials of both political parties.
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- The letter, obtained by the Post-Dispatch, referred to
a Nov. 18 conference sponsored by the National Academy of Sciences on the
OMB's plan.
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- "Speaker after speaker warned that implementation
of this proposal would lead to increased costs and delays in disseminating
information to the public and in promulgating health, safety, environmental
and other regulations, while potentially damaging the existing system of
peer review," the letter said.
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- Forging a final plan
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- John Graham, administrator of the OMB's Office of Information
and Regulatory Affairs, said the just-concluded public comment period has
been constructive.
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- "We will be using these comments to prepare a final
peer review policy that is as objective and workable as possible,"
Graham said.
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- Federal agencies have until Thursday to submit comments
on what they think about having their authority stripped.
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- There is wide concern among those in the science offices
at the EPA and Occupational Safety and Health Administration that their
agencies' responses will be based more on political realities than on the
genuine merits of the OMB's proposal.
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- Even those critical of the OMB's plan agree with the
need for peer review. The practice, which has been accepted for decades,
demands that before scientific, medical or technical findings can be determined
to be effective and safe for use or published in professional journals,
they must be evaluated for merit by other specialists in the same field.
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- Industry has not been shy about denouncing government's
system of peer review as unfair, especially when regulators determined
that their pharmaceutical product, chemical or process must be tightly
controlled because of possible danger to the public or environment. And
the White House has been equally open about its desire to reduce the regulatory
burden on industry.
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- Graham said revising peer review "is a major priority
for this administration."
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- The OMB was created in 1970 to evaluate all agency budget,
policy, legislative, regulatory and management issues on behalf of the
president.
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- Question of neutrality
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- Many in the scientific community worry that the OMB's
selection process for reviewers will taint impartiality.
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- "The proposed peer review selection criteria would
severely and unnecessarily restrict an agency's access to the most qualified
expertise," said Dr. Jordan Cohen, president of the Association of
American Medical Colleges.
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- In lengthy comments to the OMB, Cohen and a co-signer,
Robert Wells, president of the 60,000-member Federation of American Societies
for Experimental Biology, also questioned the OMB's proposed involvement
in screening emergency public health announcements.
-
- They offered examples of recent events from one agency
- the Food and Drug Administration - where a delay caused by the OMB could
have been dangerous. Among them:
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- An emergency termination of a clinical trial of anti-arrhythmic
drugs "that was not beneficial, but in fact dangerous."
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- An announcement that hormone replacement therapy for
post-menopausal women was causing adverse effects.
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- Last October's halting of a clinical trial of a cancer
drug to reduce the rate of breast cancer recurrence.
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- "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," said the
comments from the groups, which represent more than 100 medical and scientific
societies.
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- Michael Taylor, former deputy commissioner at the FDA
under the first Bush administration, warned that the OMB's involvement
in the dissemination of information on "imminent health hazards"
is dangerous.
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- Taylor cited the severe November hepatitis outbreak from
contaminated green onions at a Mexican fast food restaurant near Pittsburgh.
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- "OMB's proposal says it gets to weigh in on any
agency statement that would have a significant impact on an industry. Any
FDA warning or recall would have that nationwide impact. So should the
FDA commissioner have to go to John Graham for permission to warn people
about the possible danger from tainted green onions?" Taylor asked.
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- "That's what the plan calls for, and it's not just
FDA, it's all agencies involved with health and safety."
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- "Speed is often essential," Taylor said. "If
you discover that a heart valve is defective and killing people and can't
issue a recall until the White House has weighed in on the issue, people
could die."
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- Peer review issue
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- Graham is aware of the controversy.
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- "We understand that concerns have been raised about
how the proposed (plan) addresses emergencies," said the administrator,
who added that his department's view on the issue will be explained in
a final version of the plan.
-
- The OMB's actions are needed, according to a senior OMB
official, because "federal agencies have inconsistent peer review
policies."
-
- Some, like the Army Corps of Engineers and U.S. Department
of Agriculture, have no formal peer review policy. But others such as the
EPA and FDA have detailed policies for the mandatory evaluations, he said.
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- "Even agencies that have peer review polices have
not been found to implement them consistently," the official said.
-
- The National Resources Defense Council calls the OMB's
effort a blatant end run to "achieve what could not be achieved through
the intense campaigns to lobby to Congress to weaken pollution and safety
standards." So said Jennifer Sass, a senior scientist with the 1 million-member
environmental organization.
-
- "The integrity of the science used to support regulatory
decisions would be compromised, perhaps beyond repair," Sass said.
-
- But the OMB says it has been ordered by Congress to take
a greater role in evaluating what the agencies do.
-
- "Congress, in the Information Quality Law, required
OMB to engage in oversight of the information quality activities of federal
agencies," the senior OMB official said. "Peer review is one
of the critical activities agencies use to assure quality control of information
during pre-dissemination review."
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- Emergency declarations
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- The OMB's attempt to take control of the release of emergency
information surprises even its critics.
-
- There were headlines across the country when the EPA's
inspector general confirmed that the White House's Council on Environmental
Quality had forced downplaying of actual hazards from the collapse of the
World Trade Center buildings. And the OMB was faulted in congressional
hearings for preventing the EPA from declaring a public health emergency
regarding asbestos contamination in Libby, Mont.
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- "Incredibly, OMB's response to this widespread criticism
about political interference in public health decisions is to come right
out and explicitly propose to take authority over release of emergency
information away from health, safety and environmental officials and transfer
it into the hands" of John Graham, said Winifred De Palma, regulatory
affairs counsel for Public Citizen.
-
- The consumer advocacy organization was founded by Ralph
Nader in 1971.
-
- "OMB has no statutory or other express legal authority
to impose this type of control on the agencies," De Palma said. "If
the plan is implemented, it will mean that political considerations, and
not public health, will be the administration's primary concern in the
deciding whether to release health and safety information to the public
in emergency situations."
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- Lauded by industry
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- In public statements on its proposal, the OMB did not
cite specific cases where the existing peer review didn't work.
-
- The agency referred reporters to the comments of the
American Chemical Council, which listed six examples where it said EPA's
peer review of certain chemicals were flawed. For example, it criticized
a 2000 EPA evaluation specifying hazards of diisononyl phthalate, a plasticiser
used in soft vinyl children's products.
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- The EPA evaluation "ignored the primate data indicating
that the effects seen at high doses in rodents do not occur in primates,"
the council wrote.
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- Since his confirmation, Graham, who has a doctorate from
Harvard, has been a target for criticism from Public Citizen and other
interest groups worried about his strong ties to industry.
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- Before joining the Bush administration, Graham headed
the Harvard Center for Risk Analysis. Its research, funded mostly by corporations,
is often widely praised by industry and denounced by some public interest
groups. Graham has written or edited books on the problems of government
peer review.
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- Two of Graham's own studies on the safety of cell phones
and driving and the value of automotive air bags for children are called
scientific whitewash by some critics and praised as an unbiased evaluation
by those in the automotive and cell phone industry.
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- "Although peer review does take time and hard work,
it ultimately strengthens public health and environmental protection by
better ensuring that rules will have the intended effect and are legally
sound," said Graham, explaining the value of the proposal.
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- E-mail: aschneider@post-dispatch.com
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- Post-Dispatch [copyright]2004
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