Families Against Cancer & Toxics

Stop cancer before it starts

July 27, 2006

SAFE AND SOUND?

From: Nature, Jul. 20, 2006

By Colin Macilwain

'Bush declares war on environment,' read an unflattering CNN headline
in March 2001. It was early in the administration of President George
W. Bush, and the White House had just upwardly revised how much
arsenic it would allow in drinking water. Never mind that they had
stepped into a trap laid by former president Bill Clinton, who sharply
lowered the acceptable level of arsenic just before leaving office.
The direct approach to changing the standards didn't play well, and it
would be the last time the administration openly sought to relax a
pollution rule.

After that, the usually direct administration took a discreet approach
to reforming the way in which the US federal agencies regulate
everything from drinking-water standards and air quality to airport
security and work safety. The approach is so discreet that few outside
Washington DC even realize it exists. Its headquarters are at the
Office of Information and Regulatory Affairs, at the White House
Office of Management and Budget (OMB) -- the low-key powerhouse that
oversees the $2.7-trillion annual spending of the federal government.

Until this February, the effort's chief engineer was John Graham, a
soft-spoken, bespectacled former director of the Center for Risk
Analysis at Harvard. When Graham quit the government to run the Pardee
RAND science-policy graduate school in Santa Monica, California, he
left behind a proposal that could radically change how health, safety
and environmental rules are drawn up. Its real effect would be to
relax them, critics charge.

The OMB Bulletin on Risk Assessment landed quietly on agency
officials' desks in January. The 26-page document outlines proposed
changes to the way the government conducts risk assessments -- the
scientific studies that quantify the risks to human health, safety and
the environment caused by various activities. The bulletin is merely a
proposal at this stage and, unusually, the OMB has sent it to the
National Academies for review. An academies panel chaired by John
Ahearne, an engineer and former head of the Nuclear Regulatory
Commission now at Duke University in Durham, North Carolina, will
report on it in November. The OMB should issue its final bulletin soon
afterwards. And all federal agencies will be expected to adhere to it.

"The quality of risk assessment in the federal government is uneven,"
explains Graham. "What we're trying to attain is a standard across the
government."

But already the knives are out for the proposal. Environmental and
consumer groups charge that its real aim is to weaken regulators, such
as the Environmental Protection Agency (EPA) and the Food and Drug
Administration. "If this is adopted in anything close to its current
form," says Rena Steinzor, a regulatory-affairs specialist at the
University of Maryland in Baltimore, "it will have a devastating
impact on public health and safety regulations."

Congress is also getting involved. On 5 May, leading Democrats in the
House of Representatives fired off a letter to the president of the
National Academy of Sciences, Ralph Cicerone. In it, Tennessee's Bart
Gordon, Michigan's John Dingell and other senior Democrats ask the
National Academies to spell out the limitations of its own review. In
effect, they warn it to refrain from filing a scientific endorsement
of what they regard as a fundamentally political proposal.

"It appears impossible to provide a comprehensive answer to the
questions without reaching beyond the scope of a scientific review,"
says the letter. It goes on to charge that the "OMB's proposed
bulletin is in conflict with the approach taken in existing law" --
which, the authors say, already instructs individual agencies on how
to assess particular risks.

Both supporters and critics agree that the document is the crowning
achievement of Graham's long march to regulatory reform. It is the
fourth important element that he put in place from his powerful
position at the OMB. Three broad-ranging edicts on how agencies
should, and should not, go about the production of regulations have
already been issued: they covered 'information quality', cost-benefit
analyses and scientific peer review. The last drew a sharp and
uninvited riposte from the National Academies when it was released in
2003. The academies said it was far too prescriptive in telling
scientists how to review the work of their peers; the document was
subsequently watered down to accommodate the concerns.

The main scope of January's risk-assessment bulletin is twofold: it
offers guidance on how government agencies should go about conducting
such assessments, and broadens the set of circumstances in which they
need to be done.

Scientific risk assessments are murky affairs at the best of times.
The US environmental movement, in its 1970s heyday, strongly resisted
the very concept; greens prefer the rival paradigm of the
'precautionary principle'. This principle holds that a regulator responsible for, say, clean water, should respond to uncertainty about the toxic effects of a given chemical by setting a limit that it holds to be safe, in advance of more precise information. The approach is anathema to regulated industries, but it has been embraced, at least in theory, by political leaders in the European Union. By contrast, in the United States, where water and air quality are more tightly
regulated, risk assessment has been incorporated into many environmental laws. With the bulletin, it would be officially incorporated into all federal-agency responses to risk.

Triple bill

Graham has cited three main examples in support of the need for the
bulletin. One takes issue with a 2002 EPA estimate of the 'safe' dose
in drinking water of perchlorate -- an ingredient in solid rocket
fuel, often dumped on public land by the Department of Defense. A
subsequent, 2005 National Academies study identified a much higher
safe dose of the chemical than the EPA had done -- leading the
agency's critics to say that it should take more care before issuing
such dose estimates.

The second case also concerns the EPA, and an estimate that it made of
deaths caused from cardiopulmonary disease as a result of diesel fuel
emissions from off-road vehicles. The EPA made its estimate, Graham
argues, even as it requested millions of dollars to research the
topic. It turned out that the agency's estimate was merely a central
value between risks that might be much higher or much lower, depending
on the outcome of the research. "When an agency produces a risk
assessment with false precision," says Graham, "it engenders negative
reactions from stakeholders and from the scientific community."

His third example addresses a rather different area. The Department of
Agriculture decided to shut the Canadian border to cattle trading
after mad cow disease was found in Canadian cattle in May 2003. Graham
says that when he raised the issue of a risk assessment with
department officials, as they were considering re-opening the border,
he got "a long silence and a blank stare, as if risk assessment was a
term from a foreign language".

Only last week, a National Academies panel took sharp issue with yet
another EPA risk assessment -- a 2003 estimate of the cancer risk
posed by chemicals called dioxins. The panel, chaired by David Eaton
of the University of Washington in Seattle, said that the agency had
failed to quantify the risks in its assessment, or to justify the main
assumptions behind it.

Graham's bulletin would require government decisions to be subjected
to formal risk assessment; in emergencies, this could be completed
after the decision was implemented. Deciding what constitutes an
emergency can be difficult, however, and critics claim the regime
would stifle government action. "They won't be able to react to things
that involve a rapid decision," says Jennifer Sass of the Natural
Resources Defense Council, an environmental group based in New York.
For instance, the EPA moved swiftly to monitor mould growth in New
Orleans after Hurricane Katrina -- a response that might not be
possible under the new rules, she claims.

The measures enacted by the OMB, critics say, will provide enough
sawdust to clog up the wheels of government regulation for years to
come. "The aim is to bog the process down, in the name of
transparency," says Robert Shull, head of regulatory policy at the
pressure group OMB Watch, based in Washington DC.

Graham, a former economist, says its aim is quite the opposite. "There
will be some cases where risk assessments will become more expensive"
as a result of the bulletin, he concedes. "But their improved quality
will mean less controversy and less delay -- so we can see
opportunities for saving time and money."

Fans in commerce The measure's strongest supporters are the US Chamber
of Commerce and industry groups such as the American Chemistry
Council, headquartered in Arlington, Virginia. "It crystallizes 15 to
20 years of research on how best to do risk assessment, on the basis
of what has been said by the National Academies and others," says the
chemistry council's senior toxicologist, Richard Becker. His group has
endorsed the proposal and suggests that it be given more teeth by
making it subject to judicial review, in which an aggrieved party can
challenge the government's implementation of it.

The National Academies is accustomed to being in the middle of this
kind of fight, but it is rarely asked to review a policy proposal
before it goes into force. Sceptics smell a trap: the academies'
unsolicited intervention greatly diluted the previous White House
proposal on standardizing peer review of scientific evidence. By
asking for its advice first, the OMB can hope to implement a final
rule -- which it will write itself -- that will be difficult for
future administrations to overturn.

The only time the unflappable Graham looks ruffled is when asked if
his sending of the proposed bulletin to the academies for endorsement
might be regarded as a ploy to muffle political criticism. "Anyone who
believes that the National Academies can be used in that way doesn't
understand the process," he sniffs. "Perhaps the OMB should be given
credit for allowing its work to be criticized by the scientific
community. There was no legal requirement for it to do so."

Whatever the National Academies says in November, a rule is likely to
be implemented that will embed risk assessment more deeply in the
decision-making process. This will be John Graham's permanent legacy,
subtly moving the regulatory goalposts in industry's favour, without
catching the public's eye. "It all sounds very nice and sensible,"
says Shull. "Politically, it is much more viable than, say, trying to
weaken the drinking-water standards."
 
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