Document ID: FDA-2011-N-0920-2068
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; Supply-Chain Programs and Onsite Audits; Announcement of Effective Date
Posted Date: 2022-10-31T04:00Z

[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Rules and Regulations]
[Page 65527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23534]

[[Page 65527]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 117 and 507

[Docket Nos. FDA-2011-N-0920 and 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; Supply-Chain Programs and Onsite Audits; 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 requirements related to establishing and 
implementing supply-chain programs, records documenting supply-chain 
programs, and onsite audits in two final rules, 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, that 
appeared in the Federal Register of September 17, 2015.

DATES: The effective date for the amendments to 21 CFR 117.405(a)(2), 
117.435(d), and 117.475(c)(2), which published in the Federal Register 
of September 17, 2015 (80 FR 55908), is October 31, 2022. The effective 
date for the amendments to 21 CFR 507.105(a)(2), 507.135(d), and 
507.175(c)(2), which published in the Federal Register of September 17, 
2015 (80 FR 56170), is October 31, 2022.

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: Jennifer Erickson, Center for Veterinary Medicine (HFV-200), 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 
240-402-7382.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 17, 
2015 (80 FR 55908), we published a final rule that established 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food'' in part 117 (21 CFR part 117). 
Section 117.405(a)(2) specifies circumstances in which a receiving 
facility that is an importer need not conduct certain supplier 
verification activities. Section 117.475(c)(2) provides for 
documentation related to its supply-chain program that a receiving 
facility that is an importer is required to maintain. Section 
117.435(d) specifies that if an onsite audit is solely conducted to 
meet the supply-chain program requirements of part 117 by an audit 
agent of a certification body that is accredited in accordance with 
regulations in part 1, subpart M (21 CFR part 1, subpart M), the audit 
is not subject to the requirements in those regulations.
    At the time the final rule published, Sec. Sec.  117.405(a)(2) and 
117.475(c)(2) referred to provisions in a future final rule, ``Foreign 
Supplier Verification Programs for Importers of Food for Humans and 
Animals'' (FSVP rule) (80 FR 74226; November 27, 2015), whereas Sec.  
117.435(d) referred to a provision in a future final rule, 
``Accreditation of Third-Party Certification Bodies To Conduct Food 
Safety Audits and To Issue Certifications'' (third-party certification 
rule) (80 FR 74570; November 27, 2015). In the final rule establishing 
part 117, we stated that we would publish a document in the Federal 
Register announcing the effective dates of Sec. Sec.  117.405(a)(2), 
117.475(c)(2), and 117.435(d) (80 FR 55908 at 56131).
    In the Federal Register of September 17, 2015 (80 FR 56170), we 
published a final rule that established ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals'' in part 507 (21 CFR part 507). Section 507.105(a)(2) 
specifies circumstances in which a receiving facility that is an 
importer need not conduct certain supplier verification activities. 
Section 507.175(c)(2) provides for documentation related to its supply-
chain program that a receiving facility that is an importer is required 
to maintain. Section 507.135(d) specifies that if an onsite audit is 
solely conducted to meet the supply-chain program requirements of part 
507 by an audit agent of a certification body that is accredited in 
accordance with regulations in part 1, subpart M, the audit is not 
subject to the requirements in those regulations.
    At the time the final rule published, Sec. Sec.  507.105(a)(2) and 
507.175(c)(2) referred to provisions in a future final FSVP rule, 
whereas Sec.  507.135(d) referred to a provision in a future final 
third-party certification rule. In the final rule establishing part 
507, we stated that we would publish a document in the Federal Register 
announcing the effective dates of Sec. Sec.  507.105(a)(2), 
507.175(c)(2), and 507.135(d) (80 FR 56170 at 56330).
    The final FSVP rule and the final third-party certification rule 
published in the Federal Register on November 27, 2015, with effective 
dates of January 26, 2016.
    This document announces that the effective date for Sec. Sec.  
117.405(a)(2), 117.475(c)(2), 117.435(d), 507.105(a)(2), 507.175(c)(2), 
and 507.135(d) is October 31, 2022.

    Dated: October 21, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-23534 Filed 10-28-22; 8:45 am]
BILLING CODE 4164-01-P