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EPA/ORD | RIN: 2080-AA13 | Publication ID: Spring 2018 |
Title: Harmonize 40 CFR 26 Subparts C, D, and K With 40 CFR 26 Subpart A (the Common Rule) | |
Abstract:
Subpart A of the Federal policy for "Protection of Human Subjects" is known as the Common Rule, because this regulation is shared by 18 departments and agencies that conduct or support research involving human subjects (codified by EPA at 40 CFR 26). 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. There was a 1-year implementation deadline for most provisions. On January 19, 2018 an Interim Final Rule was published delaying implementation of the revised Common Rule for 6 months. A draft Notice of Proposed Rulemaking is currently being circulated to the agencies that would further delay implementation of the revised Common Rule until January 2019. Beyond subpart A, 40 CFR 26 also contains several additional subparts that are unique to EPA, added in 2006 in response to 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 (and EPA’s subpart A). In this rulemaking, EPA is updating subpart K for consistency with the recent updates to the Common Rule. Without appropriate updates, once the new Common Rule becomes effective, there will be a disconnect between policies and procedures based on competing versions of the same 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 should also be updated. Failure to resolve these internal discrepancies will create confusion and, more seriously, potential compliance and/or legal liabilities for researchers, institutions, and sponsors who must follow EPA regulations. These updates are solely intended to resolve discrepancies created by the recent revision to subpart A 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: Proposed Rule Stage |
Major: No | Unfunded Mandates: Undetermined |
EO 13771 Designation: Other | |
CFR Citation: 40 CFR 26 | |
Legal Authority: Not Yet Determined |
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: 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 Daniel Nelson Environmental Protection Agency Office of Research and Development 109 T.W. Alexander Drive, Mail Code 58A, Research Triangle Park, NC 27709 Phone:919 966-6217 Email: nelson.daniel@epa.gov |