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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.

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