[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Pages 66457-66458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20738]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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Food; Draft Guidance for Industry; Availability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, the Agency, or we) is 
announcing the availability of two additional draft chapters of a 
multichapter draft guidance for industry entitled ``Hazard Analysis and 
Risk-Based Preventive Controls for Human Food.'' This multichapter 
draft guidance, when finalized, will explain FDA's current thinking on 
how to comply with the requirements for hazard analysis and risk-based 
preventive controls under FDA's regulation entitled ``Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food.'' The newly available draft chapters are 
entitled ``Chapter 11--Food Allergen Program'' and ``Chapter 16--
Acidified Foods.'' This draft guidance is not final nor is it in effect 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DATES: Submit either electronic or written comments on the draft 
guidance by March 25, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

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-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.
     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 draft 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-300), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2784.

[[Page 66458]]


SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of two draft chapters entitled 
``Chapter 11--Food Allergen Program'' and ``Chapter 16--Acidified 
Foods'' 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 Preventive  81 FR 57816, August
                          Controls and Preventive    24, 2016.
                          Control Management
                          Components.
6......................  Use of Heat Treatments as  82 FR 41364, August
                          a Process Control.         31, 2017.
14.....................  Recall plan..............  84 FR 53347, October
                                                     7, 2019.
15.....................  Supply-Chain Program for   83 FR 3449, January
                          Human Food Products.       25, 2018.
Appendix 1.............  Potential Hazards for      81 FR 57816, August
                          Foods and Processes.       24, 2016.
Appendix 2.............  Food Safety Plan Forms...  81 FR 57816, August
                                                     24, 2016.
Appendix 3.............  Bacterial Pathogen Growth  81 FR 57816, August
                          and Inactivation.          24, 2016.
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    We also are announcing changes to the expected table of contents 
for the complete multichapter guidance.
    We are issuing these chapters 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 
how to comply with the requirements for hazard analysis and risk-based 
preventive controls under part 117 (21 CFR part 117), principally in 
subparts C and G. 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.
    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.
    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.

III. 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.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/FoodGuidances, https://www.fda.govregulatory-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: September 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20738 Filed 9-26-23; 8:45 am]
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