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HHS/FDA

RIN: 0910-AG66

Publication ID: Spring 2011

Title: ●Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes
Abstract: The Food and Drug Administration (FDA) is proposing regulations relating to the accreditation of third-party auditors to conduct food safety audits of foreign entities, including foreign facilities in the food import supply chain. The proposed regulations will include provisions to protect against conflicts of interest between accredited auditors and audited entities, as described in section 307 of the FDA Food Safety Modernization Act (FSMA), PL 111-353. As part of this rulemaking, FDA may propose regulations relating to the accreditation of third parties to perform related activities, such as conducting laboratory analyses of food, authorized by other sections of FSMA.
Agency: Department of Health and Human Services(HHS)	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: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: PL 111-353, sec 307, FDA Food Safety Modernization Act Other sections of FDA Food Safety Modernization Act, as appropriate

Legal Deadline:

Action	Source	Description	Date
Final	Statutory	Promulgate implementing regulations	07/00/2012

Overall Description of Deadline: Per PL 111-353, sec 307(c)(5)(C), promulgate, within 18 months of enactment, implementing regulations for accreditation of third-party auditors to conduct food safety audits.

Timetable:

Action	Date	FR Cite
NPRM	09/00/2011
NPRM Comment Period End	12/00/2011
Final Action	06/00/2012
Final Action Effective	01/00/2013

Regulatory Flexibility Analysis Required: No	Government Levels Affected: Undetermined
Federalism: No
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No
Agency Contact: Charlotte A. Christin Senior Advisor Department of Health and Human Services Food and Drug Administration Building 1 Room 3222, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-7526 Email: charlotte.christin@fda.hhs.gov