[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Contamination Event; Draft Guidance for Industry; Availability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announcing the availability of a draft guidance for industry entitled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 The draft guidance, when finalized, will explain FDA's current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DATES: Submit either electronic or written comments on the draft
guidance by May 7, 2025, to ensure that the Agency considers your
comment on the draft guidance before it begins work on the final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
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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.
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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