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EPA/ORD | RIN: 2080-AA13 | Publication ID: Spring 2019 |
Title: Harmonize 40 CFR Part 26 Subparts C, D, and K with Subpart A (the Common Rule) | |
Abstract:
In 1991, several federal departments and agencies that conduct or support research involving human subjects adopted a common 'Federal Policy for Protection of Human Subjects' into each of their own respective regulations. This policy is known as the 'Common Rule,' by virtue of being shared currently by all these departments and agencies. The Common Rule was revised through the Federal rulemaking process, and a final revised rule was jointly published in the Federal Register on January 19, 2017. Implementation of the revised Common Rule began on January 21, 2019. The Common Rule was codified by EPA in 40 CFR 26. Beyond the Common Rule language, which is located in subpart A of part 26, 40 CFR 26 also contains several additional subparts that are unique to EPA, added in 2006 in response to a Congressional mandate. In particular, EPA created subparts K through Q to regulate third-party pesticide research. Subpart K borrowed heavily from the provisions of the Common Rule. In December 2018, EPA proposed updating subpart K for consistency with the recent updates to the Common Rule. Without these updates, there is a disconnect between policies and procedures in subpart K, which are based on the previous version of the Common Rule, and the current version of the Common Rule. In addition to the textual issues in subpart K, subparts C and D contain minor numerical citations (i.e., regulatory reference numbers) that are no longer accurate and are addressed by the proposed updates to these subparts. The purpose of the updates contained in the proposed rule is to resolve these internal discrepancies and to avoid confusion and potential compliance issues for researchers, institutions and sponsors who must follow EPA regulations. If finalized, the proposed updates will resolve discrepancies created by the recent revision to the Common Rule and will not alter the fundamental protections for human subjects, including vulnerable populations. |
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Agency: Environmental Protection Agency(EPA) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Not subject to, not significant | |
CFR Citation: 40 CFR 26 | |
Legal Authority: 42 U.S.C. 300v-1(b) Pub. L. 109-54 21 U.S.C. 346(a) et seq. 7 U.S.C. 136w 7 U.S.C. 136(a) 5 U.S.C. 301 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Greg Susanke Environmental Protection Agency Office of Research and Development 1200 Pennsylvania Avenue NW, Washington, DC 20460 Phone:202 564-9945 Email: susanke.greg@epa.gov Tom Sinks Environmental Protection Agency Office of Research and Development 1200 Pennsylvania Avenue NW, Washington, DC 20460 Phone:202 564-0221 Email: staff_osa@epa.gov |