This National Academy of Sciences decision relates directly to the
testing of OP insecticides on humans so that the EPA's allowable
tolerances may be increased, by eliminating the "factor of 10"
allowed for interspecies variation, allowing higher levels of OP
exposure to the U.S. public. Notably, this may reduce
the safety factor for sensitive subpopulations, such as the
1-in-2000 persons with genetic variants of serum pseudocholinesterase,
or those with impaired protein synthesis e.g. due to chemotherapy.
As OP's are known sensitizers, it may also increase involuntary
exposure to those who have sensitized to cholinesterase inhibitors,
which may include some veterans of the 1990-1 Persian Gulf War.

Note reference to the Italian study testing an OP insecticide on
newborn infants. Vapona (TM) is dichlorvos (DDVP - dimethyl
dichlorovinyl phosphate). It is a chlorinated alkyl direct (irreversable)
inhibitor organophosphate. (CH3)2 P=O C=CCl2. Ld50 (rat) 70 mg/kg
(Parathion Ld50 (rat) is 5 mg/kg, but it is an indirect inhibitor; so
paraoxon is a better comparison). Production patent 1960 to Shell.
Dichlorvos was formerly used in those curley "pest strips", later
banned by the EPA.

As an editorial comment, it must noted that the National Academy of
Sciences' (NAS) National Research Council (NRC) is a quasi governmental
body with a charter from the U.S. Congress. It advises on federal
research, including on such things as chemical weapons incineration.
The Institute of Medicine's (IOM) Committee on Toxicology (COT)
provides prompt, confidential advice to the U.S. government on
critical issues of toxicology.

In one person's opinion, as goes the public policy, so goes the
confidential advice. Expect more human testing, higher tolerances,
and a failure to consider sensitives in the future.

"Failure to consider sensitive subpopulations is social, as opposed
to natural, selection against those individuals".

Paraphrased from:
Sheldon Samuels, AFL-CIO
"The Arrogance of Intellectual Power"
Phenotypic Variations in Populations, Relevance to Risk Assessment
Brookhaven National Laboratory (1976?)

___
Pesticide Testing on Humans Is Ethical, Science Panel Says
http://www.washingtonpost.com/ac2/wp-dyn/A56062-2004Feb19?language=printer
By Shankar Vedantam
Washington Post Staff Writer
Friday, February 20, 2004; Page A03

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.

© 2004 The Washington Post Company
___
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