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June 9, 2003
Volume 81, Number 23
CENEAR 81 23 p. 9
ISSN 0009-2347


TOXICOLOGY

EVALUATING PESTICIDES
EPA must consider human test data

BETTE HILEMAN

8123notw5.crops
APPLICATION New sprayers use less pesticide.
PHOTO BY ROB FLYNN/USDA
A
federal appeals court has struck down EPA's decision to refuse all data from human tests of pesticides conducted by third parties. However, the judicial panel left EPA an opportunity to reinstitute the ban by proposing it as a formal rule. It also said that any studies with humans must be conducted according to the highest ethical standards and must follow the Common Rule--federal policy for protection of human subjects.

The court "confirmed [EPA's] authority to reject industry human tests that do not satisfy strict regulations and the highest ethical standards," says Erik D. Olson, a senior attorney at the Natural Resources Defense Council. Under these criteria, EPA would have to reject all human tests conducted so far, he says.

However, American Chemistry Council (ACC) counsel Jamie Conrad contends that all the existing studies of pesticides using humans followed the Common Rule.

In the late 1990s, EPA reevaluated its practice of relying on data from human studies and began considering such data only on a case-by-case basis. In December 2001, the agency announced that it would not consider data from any human studies until the National Academy of Sciences reviewed the ethical issues involved.

Next, industry groups CropLife America and ACC asked the U.S. Court of Appeals for the District of Columbia Circuit to intervene. In their complaint, they said the rejection of human data by EPA was unlawful because it constituted a regulation issued without a notice of proposed rule-making. They also said EPA's decision violated two federal laws requiring the agency to consider "all relevant data." In response, EPA contended the ban was not a rule but a "policy statement."



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Related Stories
Toxicity Testing
[C&EN, Mar. 23, 2003]

Testing Of Chemicals On Humans
[C&EN, Jan. 27, 2003]

Another View Of Pesticide Use
[C&EN, Nov. 4, 2002]
Related Sites
EPA

Natural Resources Defense Council

ACC

NAS

CropLife America

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