[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]
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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.
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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]
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