The rules were revised under intense criticism from
environmental groups, scientists and members of Congress, after the disclosure
that subjects in some earlier pesticide studies were unaware of what they were
being exposed to and, in many cases, did not know why the testing was being
done.
One study would have used $2 million from the chemical
industry to measure the pesticide consumption of infants in low-income
households in Florida.
In unveiling the new rules last week, the EPA
promised full protection for those most at risk of unethical testing.
"We regard as unethical and would never conduct,
support, require or approve any study involving intentional exposure of pregnant
women, infants or children to a pesticide," the rule states.
But within the 30 pages of rules are clear-cut
exceptions that permit:
Testing of "abused or neglected" children without permission from
parents or guardians.
"Ethically deficient" human research if it is
considered crucial to "protect public health."
More than minimal health risk to a subject if there is
a "direct benefit" to the child being tested, and the parents or guardians
agree.
EPA acceptance of overseas industry
studies, which are often performed in countries that have minimal or no ethical
standards for testing, as long as the tests are not done directly for the EPA.
The EPA provided little clarification yesterday in response to questions
about the exemptions.
In a written response, officials said that abused and
neglected children were specifically singled out to create "additional
protection" for them, although they did not elaborate.
And they denied
there were any exceptions to the prohibitions on testing women and children.
They added that the new rules meet all the requirements set by Congress last
spring and summer in a series of often heated hearings.
But some of those who led the hearings disagreed.
"For the first time in our nation's history, the EPA has proposed a
program to allow for the systematic and everyday experimentation of pesticides
on humans," Rep. Henry A. Waxman, a California Democrat and leading critic of
the testing policies, said in a statement yesterday. "Moreover, the proposed
program is riddled with ethical loopholes."
Sen. Barbara Boxer, another
California Democrat, who also demanded improvements in protecting human test
subjects, voiced similar criticism.
"The EPA proposed rule on human testing has several
large loopholes that undermine the very purpose of the rule. No wonder the
pesticide companies are saying such nice things about it," Boxer said.
"This is unethical and contrary to recent direction from Congress."
Many critics believe that the agency is buckling to the pesticide
industry, which has faced much more stringent testing standards under
regulations approved in 1996.
The exemptions are "obviously driven by
the pesticide industry's goal of relaxing pesticide safety standards," said
Aaron Colangelo, a senior staff lawyer with the Natural Resources Defense Fund,
which has been involved in 18 lawsuits against the pesticide industry and
government agencies.
Public health experts, including Colangelo, said they
had no idea what the EPA meant by some of the language in the exemptions - how
the agency might define a "direct benefit" to a child, for example.
"The
rule says it's acceptable to test children if there is a direct benefit,"
Colangelo said. "How can any child possibly benefit from exposure to pesticides?
What was EPA thinking about?"
"This is ethically abhorrent, and the way
EPA described this rule is clearly misleading," he said. "In fact, the rule
expressly approves intentional chemical tests against these [at-risk groups] in
several circumstances."
Richard Wiles, senior vice
president of Environmental Working Group, said "EPA's proposal is the
[pesticide] industry's dream, and the public's nightmare."
Physicians
and lawyers offered possible explanations for some of the exemptions.
A
study that could mean higher crop yields could be justification enough for the
EPA to cite a "public health benefit" under the exemptions, said Dr. Alan
Lockwood, an expert in human-testing ethics and past president of Physicians for
Social Responsibility. 
09:19:24 EDT by 