Government Testing Dangerous Pesticides on Humans

Government Testing Dangerous
Pesticides on Humans

Published on Tuesday, November 27, 2001 in the Los Angeles Times

U.S. Will Use Once-Banned Human Tests

Pesticides: EPA says it will accept industry data gathered by giving
paid subjects chemical doses
by Elizabeth Shogren

WASHINGTON -- Three years ago, in response to mounting criticism from
environmentalists and physicians, the Clinton administration stopped
using information from industry studies conducted on humans to
determine the amount of pesticides that could be applied to fruits,
vegetables and other crops.

Now the Bush administration, siding with manufacturers on whether such
studies are ethical and scientifically valid, has told the pesticide
industry it will use data from such tests, in which paid volunteers
swallow small doses of the products.

The new policy, which the Environmental Protection Agency has not
announced, also appears to disregard the recommendations of a
scientific panel the agency assembled in late 1998. Two panel members
called for a ban on human testing of pesticides, while the 16 others
said such tests must be very limited. The panel of doctors,
bioethicists and clinical scientists urged the EPA to adopt a clear
policy on human testing, one that would require adherence to rigorous
standards and pre-approval by an independent review board.

"The force of the report was, in general, that it shouldn't be done.
There should be a very high threshold," said panel member Samuel
Gorovitz, a professor of philosophy and public administration at
Syracuse University.

The new policy could have a significant impact because it comes as the
government is beginning to reassess about 9,000 pesticide safety
levels to reflect their impact on children. In general, children can
tolerate smaller amounts of pesticides, medicines and other substances
than adults.

Federal regulators determine the amount of certain pesticides that
people can tolerate on foods, in water and in agricultural jobs
without harming their health. Too much exposure can result in
neurological damage, cancer or other serious illnesses.

Though details of the new policy are unclear, industry officials
welcome the shift. Without human tests, the government uses the
results of animal testing and multiplies that exposure level by 10 to
establish an exposure level considered safe for humans. The companies
argue that human tests provide more accurate results, allowing
pesticides to be applied to crops in larger quantities and closer to
delivery to supermarkets.

Without human tests, regulations "end up being more conservative and
more restrictive than they need to be," said Ray McAllister, vice
president for science and regulatory affairs for the pesticide trade
association.

If human subjects are not used, "you may be denying benefits not only
to the grower producing the crop but also to society that needs the
food at a reasonable price," he said. "There are secondary public
health consequences if you don't have good crop protection."

Industry officials also noted that human volunteers are regularly used
to test the effects of air pollution.

The administration first signaled the policy switch last month, when a
top EPA official told the annual meeting of the American Crop
Protection Assn. that the agency would consider the results of
clinical tests on humans.

Assistant Administrator Stephen L. Johnson "indicated the agency would
be looking at the human data that were submitted," McAllister said.

Also, documents on at least three pesticides submitted to the EPA in
recent weeks for re-registration plainly state that the agency is
considering data from tests on humans. The re-registration is mandated
by the 1996 Food Quality Protection Act, which requires the EPA to
reassess 9,000 currently registered pesticides for their impact on
children.

An EPA official, speaking on the condition of anonymity, confirmed
Johnson's remarks to the trade group, and other EPA officials
acknowledged that the administration is developing a new policy on
human testing of pesticides. But officials said they did not have
approval from top political appointees to talk about it.

In its 10-month tenure, the Bush administration has weakened an array
of Clinton administration environmental regulations and proposals,
agreeing with industry and angering environmentalists. The rollbacks
range from loosening energy efficiency standards for air conditioners
to erasing a provision that would have allowed federal land managers
to reject certain types of mines if they would cause irreparable
damage to public land.

The administration also halted the implementation of new, stricter
standards for arsenic in drinking water. After conducting its own
tests, and under pressure from Congress, the EPA announced last month
that it would adopt the Clinton administration standard.

In the decade before 1996, when the law requiring retesting of
pesticides was passed, the EPA received only a handful of human tests.
In the three years that followed, the agency received 14 new,
unsolicited human subject studies on 10 pesticides.

The controversy over human testing of pesticides erupted in 1998, when
Environmental Working Group, a Washington-based investigative
environmental organization, published a report on the plethora of
human test results arriving at the EPA for pesticide evaluations.

Then-EPA Administrator Carol Browner harshly criticized the practice,
launched the study and temporarily halted the use of such data. The
moratorium deterred companies from sponsoring and submitting results
from such tests. But because the Clinton administration never
formalized the policy, Bush administration regulators could change
their practices without a new formal policy.

The majority of human studies considered by the EPA in the past were
conducted in other countries. But in 1999, 60 volunteers in Nebraska
participated in a test of a pesticide called chlorpyrifos, which is
marketed as Lorsban or Dursban. It has been used for 30 years to keep
insects off most major crops grown in the United States.

The volunteers were paid $460. Some of them swallowed
chlorpyrifos-laced tablets, while others took placebos. Some members
of both groups experienced headaches or vomiting. Garry Hamlin,
spokesman for chlorpyrifos manufacturer Dow AgroSciences, said the
results of his company's tests showed no signs of toxicity from the
pesticide.

"The clinical test was a way of bridging the gap from a considerable
amount of existing data that would help us understand how this product
functioned in the human body, how the body metabolized it and how
quickly it excreted it," he said.

But the EPA panel of scientists found that human testing is almost
never needed for pesticides already in use because studies are already
available of agriculture workers and fruit and vegetable eaters who
have been exposed to the pesticides.

The panel suggested that at least some human subject tests used by the
EPA in the past had not met the demands of good science, saying that
"bad science is always unethical." Panel members were concerned, for
example, that previous human tests were too small to assess the risks
of pesticide exposure to the broader population or to more vulnerable
individuals.

Human testing of pesticides cannot be justified "to facilitate the
interests of industry or of agriculture," the panel concluded in its
final report, delivered in February 2000. Such studies are acceptable
only if they "promise reasonable health benefits to the individual or
society at large," it said.

Human studies could be appropriate for new pesticides, the panel
concluded, if there was no way to protect human health by testing on
rats, dogs and other laboratory animals.

Panel members were concerned that human testing of pesticides could
become widespread, especially because the 1996 law required the EPA to
give closer scrutiny to pesticides originally registered before 1984.

Recent documents regarding the pesticides phosmet, azinphos-methyl and
chlorpyrifos--insecticides used on a wide variety of fruits and
vegetables--show that the EPA is evaluating data from human tests as
well as a variety of tests on laboratory animals to determine exposure
levels.

Pesticide manufacturers want to use human tests to reduce or eliminate
regulators' current assessment method: determining safe exposure
levels for laboratory animals and then multiplying that risk factor by
10 to ensure safety for humans.

In the midst of the dispute over federal policy, California's
Department of Pesticide Regulation drafted its own policy on human
testing. The state agency considers human test data if the tests were
conducted under specific ethical and scientific guidelines.

The state agency has considered two or three human-subject tests over
the last five years, according to Glenn Brank, spokesman for
California's Department of Pesticide Regulation. One such test, for
the azinphos-methyl, persuaded regulators that humans and animals
respond in the same way to the toxins in the pesticide.

As a result, the agency allowed growers of apricots and other pitted
fruits to apply the pesticide closer to harvest time, Brank said.

Lynn Goldman, who headed the pesticide program at EPA for five years
during the Clinton administration, opposes the use of human subject
tests and strongly believes that EPA can safely regulate pesticides
with tests on animals.

She said she is "very troubled" by the use of human testing for
pesticides, because there is no possible healthful effect from taking
a pesticide-laced tablet, as there usually is for testing a
pharmaceutical. The only justification for conducting the tests is to
make more money for the pharmaceutical companies, she said.

"If they were doing something to benefit us you might look at it
differently," said Goldman, now a professor of environmental sciences
at Johns Hopkins University. "For industry, there is an enormous
amount of money in the balance; one study could make the difference of
tens of millions of dollars. That's one of the troubling ethical
issues."

Goldman also finds it disturbing that test subjects are given money to
take the pesticide tablets, saying that encourages students and
low-income individuals to participate.

Goldman said she believed that pressure from the industry prevented
the Clinton administration from finalizing a policy governing human
testing.

"When it came to new regulations or new policies like this one--and
especially around the Food Quality Protection Act that had such a
major impact on the world--we had a whole lot of push-back through the
White House from industry, and a lot of it would come at us from
Congress," she said.

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