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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Proposed Rules]
[Pages 1052-1054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31528]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 106 and 117

[Docket No. FDA-2024-D-2604]

Establishing Sanitation Programs for Low-Moisture Ready-To-Eat 
Human Foods and Taking Corrective Actions Following a Pathogen 
Contamination Event; Draft Guidance for Industry; Availability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, the Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human 
Foods and Taking Corrective Actions Following a Pathogen Contamination 
Event.'' The draft guidance, when finalized, will explain FDA's current 
thinking on establishing a routine sanitation program for low-moisture 
ready-to-eat human foods (LMRTE foods) that can help prevent 
contamination of food or a food-contact surface with a pathogen and 
will explain our current thinking for corrective actions, including 
corrective actions to remediate contamination of food-contact surfaces, 
if prevention fails.

DATES: Submit either electronic or written comments on the draft 
guidance by May 7, 2025, to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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

[[Page 1053]]

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-2604 for ``Establishing Sanitation Programs for Low-Moisture 
Ready-to-Eat Human Foods and Taking Corrective Actions Following a 
Pathogen Contamination Event.'' 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 draft guidance to 
the Office of Microbiological Food Safety, Human Foods Program, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Benjamin Warren, Office of 
Microbiological Food Safety, Human Foods Program, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-645-7004, 
[email protected]; or Linda S. Kahl, Office of Policy, 
Regulations, and Information, Human Foods Program, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2784, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Establishing Sanitation Programs for Low-Moisture Ready-to-
Eat Human Foods and Taking Corrective Actions Following a Pathogen 
Contamination Event.'' We are issuing the draft guidance consistent 
with our good guidance practices regulation (21 CFR 10.115). The draft 
guidance, when finalized, will represent 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 alternate approach if it 
satisfies the requirements of the applicable statutes and regulations.
    We are issuing this draft guidance to help manufacturers/processors 
of LMRTE foods comply with 21 CFR part 117 and, for powdered infant 
formula, 21 CFR part 106. Examples of LMRTE foods are powdered infant 
formula, peanut butter, nut butters, powdered drink mixes, chocolate, 
medical foods in powdered and paste forms, processed tree nuts, milk 
powders, powdered spices, snack foods such as chips and crackers, 
granola bars, and dry cereal. When finalized, the recommendations in 
this guidance can help manufacturers/processors of LMRTE foods consider 
and take actions to help ensure a safe and sanitary food supply through 
current good manufacturing practices and to establish and implement 
hazard analysis and risk-based preventive controls for these foods. The 
draft guidance, when finalized, will explain our current thinking on 
establishing a routine sanitation program for LMRTE foods that can help 
prevent contamination of food or a food-contact surface with a pathogen 
and will explain our current thinking on recommendations for corrective 
actions, including corrective actions to remediate contamination of 
food-contact surfaces, if prevention fails.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 106 have been approved under OMB control number 0910-
0256. The collections of information in 21 CFR part 117 have been 
approved under OMB control number 0910-0751.

III. Electronic Access

    Persons with access to the internet may obtain the draft 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.

[[Page 1054]]

    Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31528 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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