Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

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Published

October 23, 2026

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of one additional draft chapter of a multichapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under FDA's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 titled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." The newly available draft chapter is titled "Chapter 12: Control of Chemical Hazards." This draft guidance is not final nor is it in effect at this time.

Full Text

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<title>Federal Register, Volume 91 Issue 204 (Friday, October 23, 2026)</title>
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[Federal Register Volume 91, Number 204 (Friday, October 23, 2026)]
[Proposed Rules]
[Pages 66798-66799]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21669]

[[Page 66798]]

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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Food; Draft Guidance for Industry; Availability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, the Agency, or we) is
announcing the availability of one additional draft chapter of a
multichapter draft guidance for industry titled ``Hazard Analysis and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draft guidance, when finalized, will explain FDA's current thinking on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 titled ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food.'' The newly available draft chapter is titled
``Chapter 12: Control of Chemical Hazards.'' 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 January 21, 2027 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:
<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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpo.gov/fdsys/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 draft guidance to
the Office of Surveillance Strategy and Risk Prioritization, 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 requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lauren Robin, Office of Food Chemical
Safety, Dietary Supplements, and Innovation, Human Foods Program, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
429-6741; or Leah Proffitt, Office of Regulations and International
Programs, Human Foods Program, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of one additional draft chapter
of a multichapter draft guidance for industry entitled ``Hazard
Analysis and Risk-Based Preventive Controls for Human Food.'' The newly
available draft chapter is entitled ``Chapter 12: Control of Chemical
Hazards.'' 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 previously announced the availability of several chapters of
that draft guidance as shown in table 1.

[[Page 66799]]

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; Revised
89 FR 7315,
February 2, 2024.
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 and 24, 2016.
Preventive Control
Management Components.
6........................ Use of Heat Treatments 82 FR 41364, August
as a Process Control. 31, 2017.
11....................... Food Allergen Program... 88 FR 66457,
September 27,
2023.
14....................... Recall Plan............. 84 FR 53347,
October 7, 2019.
15....................... Supply-Chain Program for 83 FR 3449, January
Human Food Products. 25, 2018.
16....................... Acidified Foods......... 88 FR 66457,
September 27,
2023.
Appendix 1............... Potential Hazards for 81 FR 57816, August
Foods and Processes. 24, 2016; Revised
89 FR 7315,
February 2, 2024.
Appendix 2............... Food Safety Plan Forms.. 81 FR 57816, August
24, 2016.
Appendix 3............... Bacterial Pathogen 81 FR 57816, August
Growth and Inactivation. 24, 2016.
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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. This draft chapter addresses controls for known or
reasonably foreseeable (``potential'') chemical hazards. On February
13, 2025, the Trump Administration issued Executive Order 14212
``Establishing the President's Make American Healthy Again Commission''
(90 FR 9833). The goal of this Commission is to address the health
crisis in America and lower chronic disease and, in furtherance of this
goal, advance efforts to improve food quality and safety. This guidance
seeks to help ``Make America Healthy Again'' by improving understanding
of the regulations regarding controlling chemical hazards in foods,
including radiological hazards, pesticide and drug residues, natural
toxins, decomposition, and unapproved food or color additives, as
specified in 21 CFR 117.130(b)(1)(ii), as well as environmental
contaminants (e.g., toxic elements (e.g., lead, cadmium, arsenic),
dioxin, and per- and polyfluoroalkyl substances (PFAS)), and hazardous
chemicals that can form during food production (process-related
contaminants). Controlling chemical hazards in foods helps ensure the
safety and quality of the food supply and protect U.S. consumers.
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.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.

II. Paperwork Reduction Act of 1995

While this draft 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 either <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 one of the FDA websites listed in the previous
sentence to find the most current version of the guidance.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21669 Filed 10-22-26; 11:15 am]
BILLING CODE 4164-01-P

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