Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide; Availability, 33229-33230 [2024-08955]
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Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Rules and Regulations
8. Section 746.10 is amended by
revising paragraph (c) introductory text
and adding paragraph (c)(8), to read as
follows:
■
§ 746.10 ‘Luxury goods’ sanctions against
Russia and Belarus and Russian and
Belarusian oligarchs and malign actors.
*
*
*
*
*
(c) License exceptions. No license
exceptions may overcome the license
requirements in paragraph (a)(1) of this
section except the license exceptions
identified in paragraphs (c)(1) through
(3), (c)(7) and (8) of this section.
*
*
*
*
*
(8) License Exception MED (§ 740.23
of the EAR).
PART 762—RECORDKEEPING
9. The authority citation for 15 CFR
part 746 continues to read as follows:
■
Electronic Submissions
Authority: 50 U.S.C. 4801–4852; 50 U.S.C.
4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783.
10. Section 762.2 is amended by:
a. Revising paragraphs (b)(53) and
(54), and
■ b. Adding paragraph (b)(55).
The revisions and addition read as
follows:
■
■
§ 762.2
Records to be retained.
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(b) * * *
(53) § 750.7(c)(2), Notification of name
change by advisory opinion request;
(54) § 748.13, Certain Hong Kong
import and export licenses; and
(55) § 740.23, License Exception MED.
*
*
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*
Thea D. Rozman Kendler,
Assistant Secretary for Export
Administration.
[FR Doc. 2024–09076 Filed 4–25–24; 8:45 am]
BILLING CODE 3510–JT–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Parts 161, 164, 184, and 186
khammond on DSKJM1Z7X2PROD with RULES
[Docket No. FDA–2024–D–1669]
Revocation of Uses of Partially
Hydrogenated Oils in Foods: Guidance
for Industry; Small Entity Compliance
Guide; Availability
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notification of availability.
VerDate Sep<11>2014
15:46 Apr 26, 2024
Jkt 262001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Food and Drug Administration
AGENCY:
The Food and Drug
Administration (FDA or we) is
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.’’ The small entity compliance
guide (SECG) is intended to help small
entities comply with our regulations
after we revoked specific requirements
pertaining to the use of partially
hydrogenated oils in certain foods or as
a direct or indirect food substance.
DATES: The announcement of the
guidance is published in the Federal
Register on April 29, 2024.
ADDRESSES: You may submit either
electronic or written comments on FDA
guidances at any time as follows:
SUMMARY:
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
PO 00000
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33229
Instructions: All submissions received
must include the Docket No. FDA–
2024–D–1669 for ‘‘Revocation of Uses of
Partially Hydrogenated Oils in Foods:
Guidance for Industry; Small Entity
Compliance Guide.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the SECG to the Office of Food
Additive Safety, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-
E:\FR\FM\29APR1.SGM
29APR1
33230
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:
khammond on DSKJM1Z7X2PROD with RULES
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,
VerDate Sep<11>2014
15:46 Apr 26, 2024
Jkt 262001
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:
Frm 00048
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]]>Agencies
[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Rules and Regulations]
[Pages 33229-33230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08955]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 161, 164, 184, and 186
[Docket No. FDA-2024-D-1669]
Revocation of Uses of Partially Hydrogenated Oils in Foods:
Guidance for Industry; Small Entity Compliance Guide; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is 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.'' The small entity compliance guide (SECG) is
intended to help small entities comply with our regulations after we
revoked specific requirements pertaining to the use of partially
hydrogenated oils in certain foods or as a direct or indirect food
substance.
DATES: The announcement of the guidance is published in the Federal
Register on April 29, 2024.
ADDRESSES: You may submit either electronic or written comments on FDA
guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-D-1669 for ``Revocation of Uses of Partially Hydrogenated Oils
in Foods: Guidance for Industry; Small Entity Compliance Guide.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the SECG to the Office
of Food Additive Safety, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.
Send two self-
[[Page 33230]]
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:
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 Sec. Sec. 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, 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 Sec. 161.190;
PHOs as an optional ingredient in peanut butter under the
standard of identity for peanut butter at Sec. 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
