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Court allows human tests for pesticides

Posted - Jun. 3, 2003 at 12:20 p.m.



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WASHINGTON, Jun 03, 2003 (United Press International via COMTEX) -- A federal appeals court in Washington Tuesday struck down an Environmental Protection Agency directive curtailing pesticide testing on humans.

But the action by the three-judge panel left EPA with an opportunity to attempt to reapply the ban.

EPA relied on human studies conducted by outside laboratories or someone other than the pesticide manufacturer for decades. In the late 1990s, however, the Clinton administration began to re-evaluate the practice under pressure from environmentalists and began considering such data on a case-by-case basis.

As late as October 2001, the Bush administration EPA "made this case-by-case practice clear to the regulated community," the appeals court panel said in its opinion. "Then, however, the agency abruptly reversed its position."

In December 2001, the appeals court said, "EPA issued a directive in a press release, announcing that, pending review by the National Academy of Sciences ... of the ethical issues posed by EPA's use of third-party human studies, 'the agency will not consider or rely on any such human studies in its regulatory decision making, whether previously or newly submitted."

A group led by CropLife America -- pesticide manufacturers and a trade association -- asked the U.S. Court of Appeals for the District of Columbia Circuit to intervene.

The Washington U.S. appeals court reviews regulatory decisions by federal agencies. The court's decisions can only be reversed by the Supreme Court.

The manufacturers group contended that the EPA directive was unlawful "because it constitutes a binding regulation that was issued without the notice of proposed rulemaking and period for public comment, mandated by the Federal, Food, Drug and Cosmetic Act."

The FFDCA governs pesticide residue in the food supply.

The group said the EPA action also violated at least two other federal laws that required the agency to "consider all relevant reliable data" when issuing its regulations.

The directive had come at a particularly bad time for the pesticide industry.

In 1988, Congress amended the Federal Insecticide, Fungicide and Rodenticide Act -- which governs pesticide regulations -- so that every pesticide registered before 1984 had to be re-registered under modern standards.

"As a result," the appeals court said, "the agency is currently in the process of re-examining thousands of regulated pesticides. This process involves years of preliminary action and evaluation under both FIFRA and FFDCA, culminating in public pronouncements of the agency's position on the safety of a given pesticide."

The appeals court said the principal issue in the pesticide manufacturer challenge to the ban "is whether the EPA directive that is included in the ... press release constitutes binding regulation."

The court panel concluded that it did, rejecting EPA's contention that the ban was simply a "policy statement" that did not require public comment.

The court also rejected EPA's claim that the challengers were not injured by the directive, and therefore had no "standing" to bring the challenge.

"EPA's argument is meritless," the panel said. "The disputed directive concretely injures (the manufacturers and trade association group), because it unambiguously precludes the agency's consideration of all third-party human studies, i.e., studies that (the group members) have previously been permitted to use to verify the safety of their products."

The directive "effects a dramatic change in the agency's established regulatory regime, (and) EPA was required to follow notice and comment procedures" under federal law.

The court said it was throwing out the directive, adding, "The consequence is that the agency's previous practice of considering third-party human studies on a case-by-case basis, applying statutory requirements, the common rule and high ethical standards as a guide, is reinstated and remains in effect until it is replaced by a lawfully promulgated regulation."

There was no immediate indication whether the EPA would ask the full U.S. Appeals Court for the District of Columbia Circuit, or the Supreme Court, for review.

--

(No. 02, 1057, CropLife America et al vs. EPA.)

Copyright 2003 by United Press International.

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