[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]
BILLING CODE 4164-01-P