Document ID: FDA-2011-N-0920-2051
Agency: fda
Document Type: Rule
Title: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals; Definition of Qualified Auditor; Announcement of Effective 
Date
Posted Date: 2016-09-19T04:00Z

[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Rules and Regulations]
[Pages 64060-64061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22494]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 117 and 507

[Docket Nos. FDA-2011-N-0920, FDA-2011-N-0922]

Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food and Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals; Definition of Qualified Auditor; Announcement of Effective 
Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; announcement of effective date.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
effective date for the definition of qualified auditor in the two final 
rules that appeared in the Federal Register of September 17, 2015.

DATES: The effective date of paragraph (2) of the definition of 
qualified auditor in 21 CFR 117.3 and in 21 CFR 507.3, which published 
in the Federal Register of September 17, 2015 (80 FR 55908) and (80 FR 
56170), is September 19, 2016.

FOR FURTHER INFORMATION CONTACT: For questions relating to Current Good 
Manufacturing Practice, Hazard Analysis and Risk-Based Preventive 
Controls for Human Food: Jenny Scott, Center for Food Safety and 
Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2166.
    For questions relating to Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Food for 
Animals: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 
240-402-6246.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 17, 
2015 (80 FR 55908), we published a final rule for ``Current Good 
Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food'' (preventive controls for human food rule). In 
Sec.  117.3, we included the definition of a qualified auditor. In the 
definition, we provided examples of qualified auditors. Paragraph 2 of 
the definition reads ``An audit agent of a certification body that is 
accredited in accordance with regulations in part 1, subpart M of this 
chapter.'' At the time the final rule published, paragraph 2 referred 
to a provision in a future final rule: ``Accreditation of Third-Party 
Certification Bodies to Conduct Food Safety Audits to Issue 
Certifications'' (third-party certification rule). In the preamble to 
the preventive controls for human food rule, we stated that we would 
publish a document in the Federal Register announcing the effective 
date of paragraph (2) once we finalized the third-party certification 
rule (80 FR 55908 at 55954).
    In the Federal Register of September 17, 2015 (80 FR 56170), we 
published a final rule for ``Current Good Manufacturing Practices, 
Hazard Analysis, and Risk-Based Preventive Controls for Food for 
Animals''

[[Page 64061]]

(preventive controls for animal food rule). In Sec.  507.3, we included 
the definition of a qualified auditor. In the definition, we provided 
examples of qualified auditors. Paragraph 2 of the definition reads 
``An audit agent of a certification body that is accredited in 
accordance with regulations in part 1, subpart M of this chapter.'' At 
the time the final rule published, paragraph 2 referred to a provision 
in a future final rule: ``Accreditation of Third-Party Certification 
Bodies to Conduct Food Safety Audits to Issue Certifications'' (third-
party certification rule). In the preamble to the preventive controls 
for animal food rule, we stated that we would publish a document in the 
Federal Register announcing the effective date of paragraph (2) once we 
finalized the third-party certification rule (80 FR 55908 at 55954).
    The final third-party certification rule (80 FR 74569) published in 
the Federal Register on November 27, 2015, with an effective date of 
January 26, 2016. This document announces that the effective date for 
paragraph 2 in the definition of qualified auditor in Sec.  117.3 (80 
FR 55098 at 56147) and Sec.  507.3 (80 FR 56170 at 56339) is September 
19, 2016.

    Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22494 Filed 9-16-16; 8:45 am]
 BILLING CODE 4164-01-P