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The Environmental Protection Agency plans to tighten restrictions on human research involving pesticides as part of its obligations under a 2010 settlement agreement, an agency official told BNA Jan. 21.
EPA Administrator Lisa Jackson signed the proposed rule on Jan. 18, meeting a court-ordered deadline. The agency plans to publish a proposed rule in the Federal Register in early February that would amend its 2006 regulation governing human research with pesticides, said William Jordan, senior policy adviser at EPA's Office of Pesticide Programs.
The agency is codifying practices that have been in place since 2006, he explained.
The Natural Resources Defense Council, Pesticide Action Network North America, and several other interest groups filed a lawsuit in 2006 claiming that EPA regulations violated federal law outlining protections for pesticide testing on humans. The lawsuit was settled in June 2010 (Natural Resources Defense Council v. EPA, 2nd Cir., No. 06-820, settlement announced 6/17/10; 34 CRR 634, 6/28/10).
The proposed rule would require third-party pesticide researchers to comply with EPA standards for human research with pesticides regardless of whether they intend to submit study results to EPA, according to a prepublication version of the proposal.
The revised rules would expressly prohibit legally authorized representatives from providing consent for unborn fetuses, young children, or other subjects to participate in pesticide studies.
Additionally, the proposed rule would require EPA to consider National Academy of Sciences recommendations in its scientific and ethical reviews of human research with pesticides.
The proposed rule may affect pesticide manufacturers and others that sponsor and conduct human research with pesticides, as well as international boards that review human research with pesticides for ethical considerations.
Jordan said that in addition to meeting EPA's obligations under the settlement agreement, EPA hopes the proposed rule will quell debate about human research involving pesticides.
“We're hoping that this will serve to lessen some of the controversy and debate by making clear our commitment to having high ethical standards for human research,” Jordan told BNA.
EPA currently is accepting comments on the proposed rule. Once the proposal is published in the Federal Register, a 60-day comment period will begin. Jordan said EPA will issue a final rule by Dec. 18.
Jennifer Sass, senior scientist with the Natural Resources Defense Council, a party to the settlement agreement, said the organization is pleased that the proposed rule would close loopholes in pesticide research involving humans, but she said it is still not happy about these types of studies.
“It's unethical to test toxic pesticides on people,” Sass said. Current law does not provide sufficient protection for the most sensitive segments of society, including unborn fetuses, children, the elderly, and the sick, she said.
Sass said pesticide researchers often use small sample sizes, commonly adult males, expose them to small amounts of pesticides, track results, and then submit the results to EPA. Once a no-effect exposure level is determined, EPA generally applies a tenfold safety factor to set a standard for the general population.
“There's no way that there's only a tenfold difference between the way an adult healthy male is going to respond … and the way a fetus is going to respond,” Sass said.
EPA said it has not identified any research that meets its current requirements but does not meet the new proposed standards.
Sass agreed, saying pesticide researchers have never asked to test pregnant women, for example, but she said the proposed rule would close loopholes for studies submitted to EPA.
“As low as it is, we're hoping that by setting this bar, the pesticide industry won't conduct these kinds of studies,” Sass said.
Comments on the proposed rule should be submitted at http://www.regulations.gov and make reference to docket ID No. EPA-HQ-OPP-2010-0785.
By Avery Fellow
A draft version of the proposed rule is available at http://www.epa.gov/oppfead1/guidance/humansub-revisions.pdf.
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