Accreditation of Third-Party Auditors

Docket ID: FDA-2011-N-0146
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)

This rule establishes regulations for accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits. FDA is taking this action to improve the safety of food that is imported into the United States.

RIN: 0910-AG66
Impacts and Effects: International
CFR Citation: 21 CFR 1
Priority: Other Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Spring 2016
Agenda Stage of Rulemaking: Completed Action
Major Rule: No
Legal Authorities: 21 U.S.C. 384d, Pub. L. 111-353, sec 307 FDA Food Safety Modernization Act, 21 U.S.C. 371, 21 U.S.C. 381, 21 U.S.C. 384b, ...
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: No
Small Entities Affected: No
International Impacts: Yes
Energy Effects: No
Included in Regulatory Plan: No
Legal Deadline
JudicialOtherTo the Office of the Federal Register for publication10/31/2015
ActionDateFR Citation
NPRM07/29/201378 FR 45781
NPRM Comment Period Extended11/20/201378 FR 69603
NPRM Comment Period End11/26/2013
NPRM Comment Period Extended End01/27/2014
Final Action11/27/201580 FR 74569
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: FDA-2011-N-0143
Short Title: Accreditation of Third-Party Auditors
Keyword(s): cfsan20119, section 307, 2014-924, Accreditation of Third-Party Auditors, 2014-886, Charlotte A. Christin, CFSAN, User Fee Program to Provide for Accreditation, of Third-Party Auditors/Certification Bodies, to Conduct Food Safety Audits, and to Issue Certifications, 2014-391
Type: Rulemaking
Docket Status: OPEN
Center: CDER
Docket Item Code: N

Primary Documents

View All  (32)
Comment Period Closed
Oct 07, 2015 11:59 PM ET
Proposed Rule
Posted: 07/24/2015
ID: FDA-2011-N-0146-0181
Comment Period Closed
Oct 07, 2015 11:59 PM ET
Posted: 07/24/2015
ID: FDA-2011-N-0146-0179
Comment Period Closed
Jan 27, 2014 11:59 PM ET
Posted: 09/11/2014
ID: FDA-2011-N-0146-0132
Comment Period Closed
Jan 27, 2014 11:59 PM ET
Proposed Rule
Posted: 11/20/2013
ID: FDA-2011-N-0146-0039
Comment Period Closed
Nov 26, 2013 11:59 PM ET
Proposed Rule
Posted: 07/29/2013
ID: FDA-2011-N-0146-0024

Supporting Documents

View All  (47)
Comments Not Accepted
Supporting & Related Material
Posted: 11/27/2015
ID: FDA-2011-N-0146-0201
Comments Not Accepted
Supporting & Related Material
Posted: 11/27/2015
ID: FDA-2011-N-0146-0207
Comments Not Accepted
Supporting & Related Material
Posted: 11/27/2015
ID: FDA-2011-N-0146-0218


View All  (181)

Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Current Stage
Agency Contact
Charlotte A. Christin
Senior Advisor
Building 1 Room 3222, 10903 New Hampshire Avenue
Silver Spring, MD 20993
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.