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EPA/OCSPP

RIN: 2070-AJ76

Publication ID: Fall 2010

Title: ●Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides
Abstract: As part of a settlement agreement, EPA will propose revisions to the existing rule governing the protection of subjects in human research involving pesticides. The current rule, issued in 2006, provides protections for subjects in human research by (1) prohibiting research conducted or supported by EPA that would involve intentional exposure of human subjects who are children or pregnant or nursing women; (2) prohibiting EPA reliance in actions under the pesticide laws on research involving intentional exposure of children or pregnant or nursing women; (3) extending the substantive requirements of the Common Rule to the design and execution of research conducted by third-parties who intend to submit the data to EPA under the pesticide laws; and (4) establishing the Human Studies Review Board, an independent expert panel to review proposals for new research and reports of covered human research on which EPA proposes to rely under the pesticide laws. In settling this litigation, EPA agreed to propose to broaden the applicability of the 2006 rule to apply to research involving intentional exposure of a human subject to a pesticide, without limitation as to the regulatory statutes under which the data might be submitted, considered, or relied upon. The new proposed rule, therefore, would apply to all research with pesticides, as that term is defined in 7 U.S.C. 136(u) [Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), sec. 2(u)], submitted, considered, or relied upon under any regulatory statute that EPA administers. EPA also committed in the settlement agreement to propose amendments to the rule that would disallow consent by an authorized representative of a test subject and that would require the Agency, in its reviews of covered human research, to document its ethics and science considerations in terms of the recommendations articulated in the National Research Councils 2004 report, Intentional Human Dosing Studies for EPA Regulatory Purposes.
Agency: Environmental Protection Agency(EPA)	Priority: Other Significant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 40 CFR 26
Legal Authority: PL 109-54, sec 201 5 USC 301 42 USC 300v-1(b) 7 USC 136 to 136y 21 USC 346a

Legal Deadline:

Action	Source	Description	Date
Final	Judicial	Settlement Agreement Deadline for the Administrator's Signature	12/18/2011
NPRM	Judicial	Settlement Agreement Deadline for the Administrator's Signature	01/18/2011

Statement of Need: In 2006, EPA promulgated a regulation governing the protection of subjects in human research involving pesticides. EPA settled litigation challenging the 2006 rule by promising to conduct this rulemaking.

Summary of the Legal Basis: Public Law 109-54, section 201; 5 U.S.C. 301; 42 U.S.C. 300v-1(b); 7 U.S.C. 136 to 136y; 21 U.S.C. 346a

Alternatives: This action involves proposal of amendments to the 2006 rule consistent with a negotiated settlement, followed by receipt and response to public comments and promulgation of a final rule. Because alternative educational, voluntary, incentive-based, market-based, or other non-regulatory approaches could not resolve the legal challenge to the 2006 rule, they are not being considered. EPA retains discretion to adopt a final rule that differs from its proposal.

Anticipated Costs and Benefits: Impacts are expected to be primarily procedural and limited to the costs of supporting the rulemaking effort itself. Expected benefits from this action will result from resolution of the litigation and establishing the stability of the rules governing regulated human research with pesticides by third parties.

Risks: Although no research is known of that would fall outside the scope of the 2006 rule but within the scope of the proposed amendment, this action addresses a perceived loophole for unethical human pesticide research to be submitted to EPA and relied on by the Agency under other regulatory statutes.

Timetable:

Action	Date	FR Cite
NPRM	01/00/2011
Final Action	12/00/2011

Regulatory Flexibility Analysis Required: No	Government Levels Affected: Federal
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: Yes
RIN Information URL: http://www.epa.gov/oppfead1/guidance/human-test.htm
RIN Data Printed in the FR: No
Agency Contact: John Carley Environmental Protection Agency Office of Chemical Safety and Pollution Prevention 7501P, Washington, DC 20460 Phone:703 305-7019 Fax:703 308-4776 Email: Carley.John@epamail.epa.gov William Jordan Environmental Protection Agency Office of Chemical Safety and Pollution Prevention 7501P, Washington, DC 20460 Phone:703 305-1049 Fax:703 308-4776 Email: Jordan.William@epa.gov