Proposed Rule2024-01911
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 2, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 This multichapter draft guidance, when finalized, will explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule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 This draft guidance is not final nor is it in effect at this time.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 23 (Friday, February 2, 2024)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-01911]
=======================================================================
-----------------------------------------------------------------------
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Food; Draft Guidance for Industry; Availability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.
-----------------------------------------------------------------------
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 This multichapter draft guidance, when finalized, will explain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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
------------------------------------------------------------------------
Chapter No. Chapter title Publication
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
[[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 <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
</pre></body>
</html>Indexed from Federal Register on February 2, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.