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Daily News Archive
From August 15, 2005

EPA Draft of New Human Testing Rule Criticized
(Beyond Pesticides, August 15, 2005) An internal draft of a new proposed Environmental Protection Agency (EPA) rule on human testing with pesticides, obtained by Beyond Pesticides, fails to fulfill congressional requirements. Identifying the rule's loopholes, medical experts, congressional members, environmental groups, and EPA toxicologists, health experts, and lawyers say the rules provide insufficient measures for protecting human subjects.

While the rules do address the requirements that were established in the Interior Appropriations bill passed last month by Congress (see Daily News), such as establishing an independent advisory board and protections for children and pregnant women, the proposed rule still falls short in several areas.

"This is a very important ethical, scientific, and clinical issue, and they are going to try to fool the American public about its intent," said an EPA toxicologist who requested anonymity. Representative Henry Waxman (CA-D) calls the proposal "deeply flawed . . . [it] would allow unethical pesticide experiments on humans." (source: Baltimore Sun)

"The draft exhibits the inappropriateness of allowing human testing with pesticides and the difficultly of ensuring that a regulatory agency, especially one as politicized as EPA, adheres to even the weakest of standards," said Jay Feldman, executive director of Beyond Pesticides.

According to Public Employees for Environmental Responsibility (PEER) (see press release), the most significant weaknesses of EPA's rule, as currently drafted, includes the following:

  • Only studies identifying toxic effects would be covered, not applying to studies that test for levels of exposure, absorption or metabolism.
  • The rules would not apply to previously conducted studies.
  • Undue incentives for subjects having limited economic means and those imprisoned would be allowed.

A major concern is that EPA's proposed rule fails to protect children, fetuses, and pregnant women. Leo Trasande, M.D., assistant director of the Mount Sinai Center for Children's Health and the Environment, states that EPA is on, "a dangerous slippery slope . . . again failing in its duty to protect children from pesticides and other toxic exposures." (source: Washington Post)

Another loophole PEER identifies would allow controversial studies like the Children's Environmental Exposure Research Study (CHEERS). Such studies are particularly concerning considering the body of evidence in scientific literature showing that pesticide exposure can adversely affect a child's neurological, respiratory, immune, and endocrine system, even at low levels.

EPA's proposed rule on human testing has been submitted for review to the Office of Management and Budget, which will make recommendations. EPA can then make additional changes before the rule is published in the Federal Register, after which a 90-day public comment period will follow.

TAKE ACTION: Contact your Congress members and ask them to ensure EPA complies with recent congressional legislation.