[Federal Register Volume 89, Number 23 (Friday, February 2, 2024)]
[Proposed Rules]
[Pages 7315-7317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2016-D-2343]


Hazard Analysis and Risk-Based Preventive Controls for Human 
Food; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
announcing the availability of a revised draft Introduction, and a 
revised draft Appendix 1, within a multichapter guidance for industry 
entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human 
Food.'' This multichapter draft guidance, when finalized, will explain 
our current thinking on how to comply with the requirements for hazard 
analysis and risk-based preventive controls under our rule entitled 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food.'' We revised the draft Introduction 
and draft Appendix 1: Known or Reasonably Foreseeable Hazards 
(``Potential Hazards'') to address comments submitted on drafts that we 
made available in 2016. This draft guidance is not final nor is it in 
effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by June 3, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 7316]]

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive 
Controls for Human Food.'' 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.
    <bullet> 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 guidance to the 
Office of Food Safety (HFS-300), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740. Send two self-addressed adhesive labels to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Linda Kahl, Center for Food Safety and 
Applied Nutrition (HFS-024), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2784.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a revised draft Introduction 
and a revised draft Appendix 1 of a multichapter draft guidance for 
industry entitled ``Hazard Analysis and Risk-Based Preventive Controls 
for Human Food.'' We previously announced the availability of several 
chapters of that draft guidance as shown in table 1.

   Table 1--Available Draft Chapters in Hazard Analysis and Risk-Based
                   Preventive Controls for Human Food
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         Chapter No.              Chapter title          Publication
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N/A.........................  Introduction........  81 FR 57816, August
                                                     24, 2016.
1...........................  The Food Safety Plan  81 FR 57816, August
                                                     24, 2016.
2...........................  Conducting a Hazard   81 FR 57816, August
                               Analysis.             24, 2016.
3...........................  Potential Hazards     81 FR 57816, August
                               Associated with the   24, 2016.
                               Manufacturing,
                               Processing,
                               Packing, and
                               Holding of Human
                               Food.
4...........................  Preventive Controls.  81 FR 57816, August
                                                     24, 2016.
5...........................  Application of        81 FR 57816, August
                               Preventive Controls   24, 2016.
                               and Preventive
                               Control Management
                               Components.
6...........................  Use of Heat           82 FR 41364, August
                               Treatments as a       31, 2017.
                               Process Control.
11..........................  Food Allergen         88 FR 66457,
                               Program.              September 27, 2023.
14..........................  Recall plan.........  84 FR 53347, October
                                                     7, 2019.
15..........................  Supply-Chain Program  83 FR 3449, January
                               for Human Food        25, 2018.
                               Products.
16..........................  Acidified Foods.....  88 FR 66457,
                                                     September 27, 2023.
Appendix 1..................  Potential Hazards     81 FR 57816, August
                               for Foods and         24, 2016.
                               Processes.
Appendix 2..................  Food Safety Plan      81 FR 57816, August
                               Forms.                24, 2016.
Appendix 3..................  Bacterial Pathogen    81 FR 57816, August
                               Growth and            24, 2016.
                               Inactivation.
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[[Page 7317]]

    We are issuing these revised sections of 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 ``Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Human Food.'' 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.
    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 
enables FDA to better protect public health by helping to ensure the 
safety and security of the food supply. FSMA enables FDA to focus more 
on preventing food safety problems rather than relying primarily on 
reacting to problems after they occur. FSMA recognizes the important 
role industry plays in ensuring the safety of the food supply, 
including the adoption of modern systems of preventive controls in food 
production.
    Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic 
Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with 
requirements for hazard analysis and risk-based preventive controls for 
establishments that are required to register as food facilities under 
our regulations in 21 CFR part 1, subpart H, in accordance with section 
415 of the FD&C Act (21 U.S.C. 350d). We have established regulations 
to implement these requirements within part 117 (21 CFR part 117).
    The multichapter draft guidance for industry is intended to explain 
our current thinking on how to comply with the requirements for hazard 
analysis and risk-based preventive controls under part 117, principally 
in subparts C and G. One revised draft that we are announcing in this 
document is ``Introduction and General Information Applicable to This 
Guidance.'' We revised the draft Introduction that we made available in 
2016 to address comments submitted regarding the draft Introduction, 
include all draft definitions that we subsequently included in chapters 
we have made available, and add draft recommendations for training 
applicable to most topics covered in the multichapter guidance. We also 
added two administrative features. One feature is a comprehensive 
bibliography of references that we cited within the chapters previously 
made available, as well as references that we expect to cite in the 
additional chapters that we have included in the table of contents. 
Another feature is a compilation of resources that could be useful to 
persons who use the multichapter guidance.
    The second revised draft that we are announcing in this document is 
``Appendix 1: Known or Reasonably Foreseeable Hazards (``Potential 
Hazards'').'' We revised the draft Appendix 1 that we made available in 
2016 to add text providing context for what the Appendix is, how it was 
developed, and how it should be used. To address comments submitted 
regarding the draft Appendix, we made several changes, including: (1) 
significantly revised product categories (which emphasize ingredients 
that go into foods rather than finished foods that can be formulated 
with many variations of such ingredients); (2) replaced a series of 
tables listing known or reasonably foreseeable (``potential'') process-
related hazards with a discussion of such hazards; (3) provided a 
general discussion of food allergen hazards rather than identify known 
or reasonably foreseeable (``potential'') food allergen hazards that 
could apply to multiple product categories; and (4) identified 
scientific, technical, or regulatory information that we considered 
when identifying some hazards that are known or reasonably foreseeable 
(``potential''), but less common, hazards in some food categories.
    We intend to announce the availability for public comment of 
additional chapters of the draft guidance as we complete them. The 
titles of the additional chapters that we expect to make available for 
public comment are included in the table of contents for the complete 
multichapter guidance.

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 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.

    Dated: January 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01911 Filed 1-30-24; 4:15 pm]
BILLING CODE 4164-01-P