[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Rules and Regulations]
[Pages 64060-64061]
[FR Doc No: 2016-22494]

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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.

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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,<PHONE_NUMBER>.
    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''

(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