AR-News: News: White House seeks control on health, safety

[Lawrence Carter-Long]

White House seeks control on health, safety

Published: Sunday, Jan. 11 2004

The Office of Management and Budget wants to have the final say on
releasing emergency declarations to the public.

By Andrew Schneider
Of the Post-Dispatch [copyright]2004, St. Louis Post-Dispatch

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.

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.

The OMB also wants to manage scientific and technical evaluations - known as
peer reviews - of all major government rules, plans, proposed regulations and
pronouncements.

Currently, each federal agency controls its emergency notifications and peer
review of its projects.

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."

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."

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."

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."

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.

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.

"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.


Forging a final plan





John Graham, administrator of the OMB's Office of Information and Regulatory
Affairs, said the just-concluded public comment period has been constructive.

"We will be using these comments to prepare a final peer review policy that is
as objective and workable as possible," Graham said.

Federal agencies have until Thursday to submit comments on what they think
about having their authority stripped.

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.

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.

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.

Graham said revising peer review "is a major priority for this 
administration."

The OMB was created in 1970 to evaluate all agency budget, policy, 
legislative,
regulatory and management issues on behalf of the president.

Question of neutrality





Many in the scientific community worry that the OMB's selection process for
reviewers will taint impartiality.

"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.

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:

An emergency termination of a clinical trial of anti-arrhythmic drugs "that 
was
not beneficial, but in fact dangerous."

An announcement that hormone replacement therapy for post-menopausal women was
causing adverse effects.

Last October's halting of a clinical trial of a cancer drug to reduce the rate
of breast cancer recurrence.

"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.

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.

Taylor cited the severe November hepatitis outbreak from contaminated green
onions at a Mexican fast food restaurant near Pittsburgh.

"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.

"That's what the plan calls for, and it's not just FDA, it's all agencies
involved with health and safety."

"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."

Peer review issue



Graham is aware of the controversy.

"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.

"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."



Emergency declarations





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.

"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."


Lauded by industry





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.

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.

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.

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.

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.

"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.

Andrew Schneider
E-mail: aschneider at post-dispatch.com
Phone: 314-340-8101


Lawrence Carter-Long
e-mail: LCarter-Long(at)PosterBrat.com
Visit PosterBrat.com - "Because Sometimes A Brat Is The Best Thing To Be ..."

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