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From July 28, 2005

Congress Compromises on Human Pesticide Testing
(Beyond Pesticides, July 28, 2005)
The conference committee charged with reconciling the differences in the Interior Appropriations bill has weakened amendments that would have established a one-year moratorium on human pesticide testing. Instead, the new language prohibits EPA from accepting, considering, or relying upon human pesticide studies until EPA finalizes binding rules on human testing.

The compromise reached restricts pesticide testing on children and pregnant women, requires testing to follow the ethical guidelines of the Nuremberg Code as well as the highly criticized National Academy of Sciences, and requires the formation of an independent review board (IRB) to review all proposed studies before they begin. How the Nuremberg Code and other guidelines are interpreted and implemented will be closely watched by the environmental health and medical communtiies.

The amendments calling for the moratorium, sponsored in the House by Representative Hilda Solis (CA-D) and in the Senate by Senator Barbara Boxer (CA-D), both passed (see Daily News). The amendments would have prohibited, "the use of funds by the Administrator of the Environmental Protection Agency to accept, consider, or rely on third-party intentional dosing human studies for pesticides or to conduct intentional dosing human studies for pesticides."

However, a contradicting amendment on human pesticide testing sponsored by Senator Conrad Burns (MT-R), also passed, sending the issue to conference. The stated purpose of this amendment was, "to direct the Administrator of the Environmental Protection Agency to conduct a review of all third party intentional human dosing studies to identify or quantify toxic effects."

The language of the conference committee's report conveys the temporary ban on human pesticide testing will last between 3 and 6 months, depending on how fast EPA proposes a rule. Several requirements for the final rule are included in the language of the committee's report:

"Sec 201. None of the funds made available by this Act may be used by the Administrator of the Environmental Protection Agency to accept, consider or rely on third-party intentional dosing human toxicity studies for pesticides, or to conduct intentional dosing human toxicity studies for pesticides until the Administrator issues a final rulemaking on this subject. The Administrator shall allow for a period of not less than 90 days for public comment on the Agency's proposed rule before issuing a final rule. Such rule shall not permit the use of pregnant women, infants or children as subjects; shall be consistent with the principles proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principles of the Nuremberg Code with respect to human experimentation; and shall establish an independent Human Subjects Review Board. The final rule shall be issued no later than 180 days after enactment of this Act."

EPA rulemaking on human testing has been widely criticized during the last several years. A moratorium had been put in place during the Clinton-era, but it was reversed in 2003 by a lawsuit brought by the pesticide industry. In 2004, the National Academy of Sciences (NAS) made several recommendations addressing human testing (see Daily News). The rules EPA recently proposed disregarded NAS recommendations; did not meet international norms for human studies, such as the Nuremberg Code or the Helsinki Declaration; and prompted an internal EPA memo from toxicologists, physicians, and lawyers denouncing the established guidelines. These rules would have allowed testing on vulnerable populations such as infants, children, pregnant women, and prisoners.

The Interior Appropriations bill is slated for the House today, after which it is expected to go the Senate and the President before the August congressional recess.