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EPA/OPPTS

RIN: 2070-AD57

Publication ID: Spring 2002

Title: Acceptability of Research Using Human Subjects
Abstract: EPA is evaluating how its current policy with respect to the protection of human research subjects should be applied to testing not conducted or supported by the Agency. Current EPA regulations apply to research conducted or supported by the Agency or otherwise subject to regulation. No action has been taken to give effect to the otherwise-subject-to-regulation phrase. In addition, EPA has asked the advice of the National Academy of Sciences on several issues surrounding the acceptability and interpretation of third-party studies involving deliberate dosing of human subjects for the purpose of defining or quantifying toxic endpoints. EPA will seek public comment on issues related to Agency use of human research data in its regulatory decisionmaking. EPA believes the process being initiated will serve two important Agency goals: ensuring the availability of sound and appropriate scientific data in its decisions, and protection of the interests, rights and safety of human research subjects. EPA may issue one or more documents, which may include policy statements, rulemaking or requests for public comment.
Agency: Environmental Protection Agency(EPA)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
Major: No	Unfunded Mandates: No
CFR Citation: 40 CFR 26 (Revision)
Legal Authority: 7 USC 136a 21 USC 346a

Legal Deadline: None

Statement of Need: In July 1998, the Agency committed that EPA would not consider human research on pesticides in support of decisions under the Food Quality Protection Act revisions to FIFRA and FFDCA unless a policy were in place that could assure any such studies met the highest scientific and ethical standards. The Agency convened a special joint subcommittee of the FIFRA Scientific Advisory Panel and the EPA Science Advisory Board to advise on this policy. The subcommittee has completed its work. If deemed acceptable for consideration, some human research already performed could significantly affect the Agency's risk assessments of some pesticides. Clarification of Agency policy with respect to use of human data is thus needed.

Summary of the Legal Basis: FIFRA sec. 3 authorizes EPA to define data requirements supporting pesticide decisions and to establish guidelines for conducting research to support pesticide decisions. FFDCA sec. 408 authorizes EPA to consider available and reliable data in support of pesticide tolerance decisions.

Alternatives: Still to be identified.

Anticipated Costs and Benefits: No analysis has been performed yet.

Risks: No analysis has been performed yet.

Timetable:

Action	Date	FR Cite
ANPRM	07/00/2003

Additional Information: SAN No. 4610
Regulatory Flexibility Analysis Required: No	Government Levels Affected: Federal
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: Yes
Sectors Affected: 32532 Pesticide and Other Agricultural Chemical Manufacturing
Agency Contact: Vanessa Vu Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7201M, Washington, DC 20460 Phone:202 564-8429 Fax:202 564-8452 Email: vu.vanessa.@epa.gov John Carley Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7501P, Washington, DC 20460 Phone:703 305-7019 Fax:703 308-4776 Email: Carley.John@epamail.epa.gov