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Protections for Subjects in Human Research Involving Pesticides

pesticide · Rule · Published 2013-02-14 · Effective 2013-04-15 · 78 FR 10538

Document

Document number
2013-03456
Federal Register citation
78 FR 10538
CFR reference
40 CFR 26
Type
Rule
Action
Final rule.
Category
pesticide
Publication date
2013-02-14
Effective date
2013-04-15
EPA docket
EPA-HQ-OPP-2010-0785

Abstract

EPA is finalizing narrowly tailored amendments to the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The amendments broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The amendments also disallow participation in third- party pesticide studies by subjects who cannot consent for themselves. Finally, the amendments identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). The amendments make no changes to the current Federal Policy for the Protection of Human Subjects (the "Common Rule"), which governs research with human subjects conducted or supported by EPA and many other Federal departments and agencies.

Source

Authoritative
Federal Register document
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