Food Additives Permitted in Feed and Drinking Water of Animals; Condensed, Extracted Glutamic Acid Fermentation Product, 33230-33231 [2024-09073]
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Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Rules and Regulations
addressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Ellen Anderson, Center for Food Safety
and Applied Nutrition, Office of Food
Additive Safety (HFS–255), Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1309;
or Philip Chao, Center for Food Safety
and Applied Nutrition, Office of
Regulations and Policy (HFS–024), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
2378.
SUPPLEMENTARY INFORMATION:
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I. Background
We are announcing the availability of
a guidance for industry entitled
‘‘Revocation of Uses of Partially
Hydrogenated Oils in Foods: Guidance
for Industry; Small Entity Compliance
Guide.’’ We are issuing this SECG
consistent with our good guidance
practices regulation (21 CFR 10.115).
The SECG represents the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
In the Federal Register of August 9,
2023 (88 FR 53764), we published a
direct final rule entitled ‘‘Revocation of
Uses of Partially Hydrogenated Oils in
Foods’’ (‘‘the final rule’’). The final rule
amends our regulations that provide for
the use of partially hydrogenated oils
(PHOs) in food in light of our
determination that PHOs are no longer
generally recognized as safe (GRAS).
The final rule:
• Removes PHOs as an optional
ingredient in the standards of identity
for canned tuna and for peanut butter at
§§ 161.190 (21 CFR 161.190) and
164.150 (21 CFR 164.150), respectively;
• Revises our regulations affirming
food substances as GRAS pertaining to
menhaden oil (21 CFR 184.1472) and to
low erucic acid rapeseed oil (LEAR oil)
(21 CFR 184.1555) to no longer include
partially hydrogenated forms of these
oils;
• Deletes the regulation affirming
partially hydrogenated fish oil as GRAS
as an indirect food substance (21 CFR
186.1551); and
• Revokes prior sanctions for the use
of PHOs in margarine, shortening, and
bread, rolls, and buns. (A ‘‘prior
sanction’’ exempts a specific use of a
substance in food from the definition of
food additive and from all related food
additive provisions of the Federal Food,
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Drug, and Cosmetic Act if the use was
sanctioned or approved before
September 6, 1958. In accordance with
our general regulations regarding prior
sanctions, we may revoke a prior
sanctioned use of a food ingredient
where scientific data or information
demonstrate that prior-sanctioned use of
the food ingredient may be injurious to
health (see 21 CFR 181.1).)
The final rule became effective on
December 22, 2023 (88 FR 86580,
December 14, 2023).
Because we revised, removed, or
revoked the regulations mentioned
above, the SECG informs small entities
that they should no longer use:
• PHOs as an optional ingredient in
canned tuna under the standard of
identity for canned tuna at § 161.190;
• PHOs as an optional ingredient in
peanut butter under the standard of
identity for peanut butter at § 164.150;
• Partially hydrogenated versions of
menhaden oil or LEAR oil as a direct
food substance;
• Partially hydrogenated fish oil as an
indirect food substance used as a
constituent of cotton and cotton fabrics
used for dry food packaging; and
• PHOs as an ingredient in margarine,
shortening, bread, rolls, and buns.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/FoodGuidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–08955 Filed 4–26–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA–2024–F–1850]
Food Additives Permitted in Feed and
Drinking Water of Animals;
Condensed, Extracted Glutamic Acid
Fermentation Product
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
food additive regulations to update the
production organism Corynebacterium
lilium that has been scientifically
reclassified to Corynebacterium
glutamicum. This action is being taken
to improve the accuracy and clarity of
the regulations.
SUMMARY:
DATES:
This rule is effective April 29,
2024.
FOR FURTHER INFORMATION CONTACT:
Chelsea Cerrito, Center for Veterinary
Medicine (HFV–221), Food and Drug
Administration, 12225 Wilkins Ave.,
Rockville, MD 20852, 240–402–6729,
Chelsea.Cerrito@fda.hhs.gov.
FDA is
amending the food additive regulation
at 21 CFR 573.500 Condensed, extracted
glutamic acid fermentation product for
use in animal feed to update the
production organism Corynebacterium
lilium that has been scientifically
reclassified to Corynebacterium
glutamicum. This action is being taken
to improve the accuracy and clarity of
the regulations.
Publication of this document
constitutes final action under the
Administrative Procedures Act (5 U.S.C.
553). FDA has determined that notice
and public comment are unnecessary
because this amendment to the
regulations provides only technical
changes to update scientific
nomenclature and is nonsubstantive.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and the Public
Health Service Act, and under the
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 573 is
amended as follows:
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Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Rules and Regulations
PART 573—FOOD ADDITIVES
PERMITTED IN FEED AND DRINKING
WATER OF ANIMALS
1. The authority citation for part 573
continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348.
§ 573.500
[Amended]
2. In § 573.500, in paragraph (a),
remove the words ‘‘Corynebacterium
lilium’’ and add in their place the words
‘‘Corynebacterium glutamicum’’.
■
Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09073 Filed 4–26–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2024–0157]
RIN 1625–AA87
Security Zone; Port Valdez and Valdez
Narrows, Valdez, AK
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
The current Trans-Alaska
Pipeline Valdez Terminal complex
(Terminal) security zone encompasses a
waterside portion and 2000 yards
inland, which includes the shoreside
portion of the terminal and adjacent
land. The Coast Guard is amending the
TAPS Terminal security zone to exclude
the land portion from the security zone.
The Coast Guard has never exercised
any legal authority, nor has it enforced
regulations within the inland portion of
the security zone.
DATES: This rule is effective May 29,
2024.
SUMMARY:
To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2024–
0157 in the search box and click
‘‘Search.’’ Next, in the Document Type
column, select ‘‘Supporting & Related
Material.’’
khammond on DSKJM1Z7X2PROD with RULES
ADDRESSES:
If
you have questions about this rule, call
or email Lieutenant Junior Grade
Abigail Ferrara, Marine Safety Unit
Valdez, US Coast Guard. Telephone
907–835–7209, email
Abigail.C.Ferrara@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
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I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port Prince William
Sound
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
TAPS Trans-Alaska Pipeline
U.S.C. United States Code
II. Background Information and
Regulatory History
In response to the terrorist attacks on
September 11, 2001, the Coast Guard
instituted several temporary security
zones in the Trans-Alaska Pipeline
(TAPS) Terminal and Port Valdez areas.
Between 2002 and 2004, Coast Guard
published several proposed and
supplemental proposed rulemakings to
establish security zones in the area. This
culminated with a final rule (71 FR
2152) published on January 13, 2006,
which established the current
permanent security zones in 33 CFR
165.1710.
The current TAPS Terminal security
zone encompasses a waterside portion
and 2000 yards inland, which includes
the shoreside portion of the terminal
and adjacent land. The Coast Guard has
never exercised any legal authority, nor
has it enforced regulations within the
inland portion of the security zone. The
Captain of the Port Prince William
Sound (COTP) determined that the
current practice of non-enforcement
within the inland portion of the security
zone could create confusion for future
stakeholders and the public. It would be
an arbitrary and unreasonable burden
upon the facility and industry
employees who have freely entered the
inland portion without COTP
permission for decades if a COTP were
to begin enforcing their authority over
the inland portion of the security zone
in the future.
The Coast Guard is issuing this
rulemaking under authority in 46 U.S.C.
70051 and 70124.
On February 20, 2024, the Coast
Guard published a notice of proposed
rulemaking (NPRM) titled Security
Zone; Port Valdez and Valdez narrows,
Valdez, AK (89 FR 13015). There we
stated why we issued the NPRM and
invited comments on our proposed
regulatory action related to this security
zone. During the comment period that
ended March 22, 2024, we received no
comments.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 46 U.S.C. 70051 and
70124. The COTP determined that the
current practice of non-enforcement
PO 00000
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33231
within the inland portion of the security
zone could create confusion for future
stakeholders and the public. It would be
an arbitrary and unreasonable burden
upon the facility and industry
employees who have freely entered the
inland portion without COTP
permission for decades if a COTP were
to begin enforcing their authority over
the inland portion of the security zone
in the future. The purpose of this rule
is to prevent future confusion.
IV. Discussion of Comments, Changes,
and the Rule
As noted above, we received no
comments on our NPRM published
February 20, 2024. There are no changes
in the regulatory text of this rule from
the proposed rule in the NPRM.
The COTP is amending the current
security zone found in 33 CFR
165.1710(a)(1) to excise the 2000-yard
inland portion of the zone. This will
result in the security zone
encompassing only the water up to the
shoreline. The regulatory text we are
amending appears at the end of this
document.
V. Regulatory Analyses
We developed this rule after
considering numerous statutes and
Executive orders related to rulemaking.
Below we summarize our analyses
based on a number of these statutes and
Executive orders.
A. Regulatory Planning and Review
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits.
This rule has not been designated a
‘‘significant regulatory action,’’ under
section 3(f) of Executive Order 12866, as
amended by Executive Order 14094
(Modernizing Regulatory Review).
Accordingly, this rule has not been
reviewed by the Office of Management
and Budget (OMB).
This regulatory action determination
is based on the size and location of the
current waterside portion security zone
remaining the same. Moreover, the
landside portion of the facility has had
other security regulations in place for
roughly two decades.
B. Impact on Small Entities
The Regulatory Flexibility Act of
1980, 5 U.S.C. 601–612, as amended,
requires Federal agencies to consider
the potential impact of regulations on
small entities during rulemaking. The
term ‘‘small entities’’ comprises small
businesses, not-for-profit organizations
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]]>Agencies
[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Rules and Regulations]
[Pages 33230-33231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09073]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2024-F-1850]
Food Additives Permitted in Feed and Drinking Water of Animals;
Condensed, Extracted Glutamic Acid Fermentation Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to update the production organism Corynebacterium
lilium that has been scientifically reclassified to Corynebacterium
glutamicum. This action is being taken to improve the accuracy and
clarity of the regulations.
DATES: This rule is effective April 29, 2024.
FOR FURTHER INFORMATION CONTACT: Chelsea Cerrito, Center for Veterinary
Medicine (HFV-221), Food and Drug Administration, 12225 Wilkins Ave.,
Rockville, MD 20852, 240-402-6729, [email protected].
SUPPLEMENTARY INFORMATION: FDA is amending the food additive regulation
at 21 CFR 573.500 Condensed, extracted glutamic acid fermentation
product for use in animal feed to update the production organism
Corynebacterium lilium that has been scientifically reclassified to
Corynebacterium glutamicum. This action is being taken to improve the
accuracy and clarity of the regulations.
Publication of this document constitutes final action under the
Administrative Procedures Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because this amendment to the
regulations provides only technical changes to update scientific
nomenclature and is nonsubstantive.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and the
Public Health Service Act, and under the authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 573 is amended as follows:
[[Page 33231]]
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for part 573 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348.
Sec. 573.500 [Amended]
0
2. In Sec. 573.500, in paragraph (a), remove the words
``Corynebacterium lilium'' and add in their place the words
``Corynebacterium glutamicum''.
Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09073 Filed 4-26-24; 8:45 am]
BILLING CODE 4164-01-P
