Rule2022-23534
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 31, 2022
Effective
September 17, 2015
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 209 (Monday, October 31, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23534]
[[Page 65527]]
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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 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.
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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
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</html>Indexed from Federal Register on October 31, 2022.
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