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Important article even if not radiation related
The following appeared in today's Washington Post.
The implications regarding the setting of regulatory
limits may be influenced not only for the use of
chemicals and pesticides, but may have implication for
ALARA decision making.
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Pesticide Testing on Humans Is Ethical, Science
Panel Says
By Shankar Vedantam
It is ethical to test pesticides and pollutants on
human volunteers in order to determine whether
environmental safety standards can be lowered, a top
panel of scientists said yesterday in an opinion that
is expected to strongly influence government policy.
Many scientists and ethicists have argued that such
research is never justified, and yesterday's
unprecedented verdict by the National Academy of
Sciences took environmentalists by surprise.
The pesticide industry has vehemently supported such
tests for years, arguing that current regulatory
limits on exposure to environmental toxins are overly
cautious. Manufacturers of pesticides and companies
that produce pollutants say human studies will
demonstrate that higher levels of toxins in the air
and water are not harmful.
While volunteers would derive no benefit and some
might incur transient harm, the panel of experts said
this would be outweighed by societal benefits. Besides
helping regulators set accurate benchmarks for
environmental dangers, such trials might also address,
for example, how much insecticide can safely be used
to fight a malaria outbreak.
Yesterday's decision by a panel of the National
Research Council will allow the Environmental
Protection Agency to devise a final rule over the next
several months, an EPA spokesman said. Both the
pesticide industry and environmental groups said they
expect the agency will accept the recommendation of
the panel, which would also allow the EPA to evaluate
human studies of pesticides that had previously been
conducted, and give the industry an incentive to
conduct new trials.
The panelists called for a rigorous safety and ethics
system to evaluate and approve such trials, much like
the system used by the Food and Drug Administration to
evaluate drug trials conducted by the pharmaceutical
industry.
While there was no "foolproof mechanism" to eliminate
all risk of patient harm, the joint chairman of the
panel, James Childress, an ethics professor at the
University of Virginia, said that the risk for
volunteers would generally be "exceedingly low."
Environmental groups acknowledged that the panel had
tried to institute safeguards, but feared that trials
would still cause harm.
Currently, to determine what level of a toxin is safe
for human exposure, regulators at the EPA first
determine what dose is toxic to animals. Regulators
divide that dose by 10, because humans may react more
sensitively than animals -- called the "inter-species
safety factor." Because some people are more
sensitive than others, regulators lower the
potentially toxic dose by another factor of 10.
Finally, to protect children and fetuses, a third
safety factor of as much as 10 is introduced.
Collectively, these safety factors can reduce human
exposure limits to toxins to one-thousandth the dose
that harms animals.
The goal of human pesticide studies is to lower the
inter-species factor. If companies can show that
humans are not more sensitive than rats, higher
exposure levels might be permitted.
Richard Wiles, senior vice president at the
Environmental Working Group, an advocacy organization,
said that while the EPA can enforce a tenfold safety
factor to protect children, it does not do so for many
chemicals. As a result, he said, the exposure limit
for humans might end up being only one-tenth the toxic
animal dose.
"Pesticide law would have gone from the toughest law
on the books to the weakest law on the books through
this marvelous sleight of hand that the industry has
pulled," Wiles said.
The report allowed for the possibility of trials
involving children, but panelists said they could not
imagine such tests would ever be conducted. But Erik
Olson, senior attorney at the Natural Resources
Defense Council, an environmental group, said such
tests have already been performed: As recently as
2000, he said, a manufacturer petitioned the EPA to
consider data from an Italian study of infants that
deliberately exposed them to dichlorvos, an
insecticide sold under the brand name Vapona.
Dichlorvos manufacturer Amvac Chemical Corp., of
Newport Beach, Calif., petitioned the agency to
consider two 1969 trials titled "Exposure of Newborn
Babies to Vapona Insecticide" and "Clinical Effects of
Exposure to DDVP (Vapona) Insecticide in Hospital
Wards."
A call to Amvac was returned by consultant Howard
Berman, president of Environmental Mediation Inc.
Berman said that the trials cited in the petition had
not been commissioned by Amvac. Speaking on behalf of
the company, he said Amvac had no plans to conduct
trials among children.
Jay Vroom, president of Croplife America, which
represents pesticide manufacturers, said he knew of no
company that planned to test pesticides on children.
But data from adult trials would be useless in
predicting the risk for children, said Philip
Landrigan, a Mount Sinai pediatrician in New York and
chairman of a National Academy of Sciences panel in
1993 that examined the risk of pesticides on children.
During the Clinton administration, the EPA refused
to consider any human trials. The Bush administration
reopened the possibility of using the tests.
The pesticide industry dismissed critics of the
trials as biased, and environmental groups countered
yesterday with similar criticism of the NRC panel.
Olson, the NRDC attorney, produced documentation that
panel member James Bruckner, a professor of
pharmacology and toxicology at the University of
Georgia, was a paid expert witness for Lockheed Martin
Corp., which is fighting a lawsuit in California over
whether pollution from its products might have caused
cancer and thyroid problems.
Gail Rymer, a spokeswoman for Lockheed Martin in
Bethesda, confirmed that the company had paid for a
human study of a rocket fuel component called
perchlorate in hopes of influencing the California
lawsuit.
Bruckner and the National Academy of Sciences said
there was no conflict of interest because he testified
as an expert on a chemical called trichloroethylene
and did not know about the perchlorate study.
Olson and Gary Praglin, who is suing Lockheed Martin
on behalf of alleged victims in Redlands, Calif., said
the argument was specious.
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(c) 2004 The Washington Post Company
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"The care of human life and happiness . . . is the first and only legitimate object of good government."
Thomas Jefferson
-- John
John Jacobus, MS
Certified Health Physicist
e-mail: crispy_bird@yahoo.com
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