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, 65527 [2022-23534]
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Federal Register / Vol. 87, No. 209 / Monday, October 31, 2022 / Rules and Regulations
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 RiskBased Preventive Controls for Food for
Animals; Supply-Chain Programs and
Onsite Audits; Announcement of
Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Final rule; announcement of
effective date.
ACTION:
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 RiskBased Preventive Controls for Human
Food and Current Good Manufacturing
Practice, Hazard Analysis, and RiskBased 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
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:51 Oct 28, 2022
Jkt 259001
(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 supplychain 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,
§§ 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
§ 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 §§ 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 supplychain 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.
PO 00000
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Fmt 4700
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65527
At the time the final rule published,
§§ 507.105(a)(2) and 507.175(c)(2)
referred to provisions in a future final
FSVP rule, whereas § 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 §§ 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 §§ 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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2022–0789]
RIN 1625–AA00
Safety Zone; Upper Mississippi River
Mile Marker 485.3–485.9 Davenport, IA
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone for
all navigable waters in the Upper
Mississippi River at Mile Marker (MM)
485.3 through 485.9. The safety zone is
needed to protect personnel, vessels,
and the marine environment from all
potential hazards associated with
electrical line work. Entry of vessels or
persons into this zone is prohibited
unless specifically authorized by the
Captain of the Port Sector Upper
Mississippi River (COTP) or a
designated representative.
DATES: This rule is effective from
October 31, 2022 through November 23,
2022.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2022–
0789 in the search box and click
‘‘Search.’’ Next, in the Document Type
SUMMARY:
E:\FR\FM\31OCR1.SGM
31OCR1
]]>Agencies
[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]]
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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.
-----------------------------------------------------------------------
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
