83 FR 3449 - Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 17 (January 25, 2018)

Page Range		3449-3450
FR Document		2018-01299

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry.'' This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk- based preventive controls under our rule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.'' The newly available draft chapter is entitled ``Chapter 15--Supply-Chain Program for Human Food Products.''

Federal Register, Volume 83 Issue 17 (Thursday, January 25, 2018)

[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Proposed Rules]
[Pages 3449-3450]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01299]

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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Food; Draft Guidance for Industry; Availability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 Agency) is
announcing the availability of another draft chapter of a multichapter
guidance for industry entitled ``Hazard Analysis and Risk-Based
Preventive Controls for Human Food: Draft Guidance for Industry.'' This
multichapter draft guidance is intended to explain our current thinking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.'' The newly available draft chapter is
entitled ``Chapter 15--Supply-Chain Program for Human Food Products.''

DATES: Submit either electronic or written comments by May 25, 2018 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ensure that the Agency considers your comment on this draft guidance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: Draft Guidance for Industry.'' 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.
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.thefederalregister.org/fdsys/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.
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
Office of Food Safety, Center for Food Safety and Applied Nutrition,
Food and Drug Administration (HFS-300), 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: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2166.

SUPPLEMENTARY INFORMATION:

I. Background

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. It 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 section 418 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 350g) by adding 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).

[[Page 3450]]

In the Federal Register of August 24, 2016 (81 FR 57816), we
announced the availability of several chapters (Chapters 1-5) of a
multichapter draft guidance for industry entitled ``Hazard Analysis and
Risk-Based Preventive Controls for Human Food.'' In the Federal
Register of August 31, 2017 (82 FR 41364), we announced the
availability of an additional chapter (Chapter 6). We now are
announcing the availability of an additional draft chapter of this
multichapter guidance for industry.

II. Significance of Guidance

This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on ``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. This guidance
is not subject to Executive Order 12866.
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. The chapter that we are announcing in this
document is entitled ``Chapter 15--Supply-Chain Program for Human Food
Products.''
We intend to announce the availability for public comment of
additional chapters of the draft guidance as we complete them.

III. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 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 either https://www.fda.gov/FoodGuidances 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 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01299 Filed 1-24-18; 8:45 am]
BILLING CODE 4164-01-P

3450 Federal Register / Vol. 83, No. 17 / Thursday, January 25, 2018 / Proposed Rules

In the Federal Register of August 24, Dated: January 18, 2018. I. Table of Abbreviations
2016 (81 FR 57816), we announced the Leslie Kux,
CFR Code of Federal Regulations
availability of several chapters (Chapters Associate Commissioner for Policy. DHS Department of Homeland Security
1–5) of a multichapter draft guidance for [FR Doc. 2018–01299 Filed 1–24–18; 8:45 am] FR Federal Register
industry entitled ‘‘Hazard Analysis and BILLING CODE 4164–01–P NPRM Notice of proposed rulemaking
Risk-Based Preventive Controls for § Section
Human Food.’’ In the Federal Register U.S.C. United States Code
of August 31, 2017 (82 FR 41364), we DEPARTMENT OF HOMELAND
announced the availability of an SECURITY II. Background, Purpose, and Legal
additional chapter (Chapter 6). We now Basis
are announcing the availability of an Coast Guard
The City of Fort Lauderdale notified
additional draft chapter of this the Coast Guard that it will be hosting
multichapter guidance for industry. 33 CFR Part 100
the Fort Lauderdale Air Show annually
II. Significance of Guidance [Docket Number USCG–2017–0993] on one weekend (Saturday and Sunday)
RIN 1625–AA00 during the month of May. The regulated
This level 1 draft guidance is being area would cover all navigable waters of
issued consistent with FDA’s good Special Local Regulation: Fort the Atlantic Ocean, east of Fort
guidance practices regulation (21 CFR Lauderdale Air Show; Atlantic Ocean, Lauderdale, Florida beginning at the
10.115). The draft guidance, when Fort Lauderdale, FL Port Everglades Inlet and continues
finalized, will represent the current north for approximately six miles. The
AGENCY: Coast Guard, DHS.
thinking of FDA on ‘‘Hazard Analysis regulated area is intended to protect
and Risk-Based Preventive Controls for ACTION: Notice of proposed rulemaking. personnel, vessels, and the marine
Human Food’’. It does not establish any SUMMARY: The Coast Guard proposes to environment from potential hazards
rights for any person and is not binding establish a recurring special local during aerobatic maneuvers by high
on FDA or the public. You can use an regulation for navigable waters of the speed, low flying airplanes and high
alternate approach if it satisfies the Atlantic Ocean, east of Fort Lauderdale, speed vessels during the air show. Over
requirements of the applicable statutes Florida beginning at the Port Everglades the years, there have been unfortunate
and regulations. This guidance is not Inlet. This action is necessary to ensure instances of aircraft mishaps during
subject to Executive Order 12866. the safety of the general public, performances at various air shows
The multichapter draft guidance for spectators, vessels, and the marine around the world. Occasionally, these
industry is intended to explain our environment from potential hazards incidents result in a wide area of
current thinking on how to comply with during aerobatic maneuvers conducted scattered debris in the water that can
the requirements for hazard analysis by high-speed, low-flying airplanes and damage property or cause significant
and risk-based preventive controls any high speed vessels performing injury or death to the public observing
under part 117, principally in subparts inside of the regulated area during the the air shows. The Captain of the Port
C and G. The chapter that we are Fort Lauderdale Air Show. This Miami has determined that a special
announcing in this document is entitled proposed rulemaking would prohibit local regulation is necessary to protect
persons and non-participant vessels the general public from hazards
‘‘Chapter 15—Supply-Chain Program for
from entering, transiting through, associated with aerial flight
Human Food Products.’’
anchoring in, or remaining within the demonstrations.
We intend to announce the regulated area unless authorized by the The Coast Guard proposes this
availability for public comment of Captain of the Port Miami or a rulemaking under authority in 33 U.S.C.
additional chapters of the draft guidance designated representative. We invite 1231.
as we complete them. your comments on this proposed
rulemaking. III. Discussion of Proposed Rule
III. Paperwork Reduction Act of 1995
DATES: Comments and related material This rule establishes a special local
This draft guidance refers to must be received by the Coast Guard on regulation on the waters of the Atlantic
previously approved collections of or before February 26, 2018. Ocean, east of Fort Lauderdale, Florida
information found in FDA regulations. ADDRESSES: You may submit comments beginning at the Port Everglades Inlet
These collections of information are identified by docket number USCG– and continuing north for approximately
subject to review by the Office of 2017–0993 using the Federal six miles. The duration of the regulated
Management and Budget (OMB) under eRulemaking Portal at http:// area is intended to ensure the safety of
the Paperwork Reduction Act of 1995 www.regulations.gov. See the ‘‘Public the public during the aerial flight
(44 U.S.C. 3501–3520). The collections Participation and Request for demonstrations and high speed boat
of information in part 117 have been Comments’’ portion of the races. Non participant vessels are not
approved under OMB control number SUPPLEMENTARY INFORMATION section for
permitted to enter, transit through,
0910–0751. further instructions on submitting anchor in, or remain within the
comments. regulated area without obtaining
IV. Electronic Access
sradovich on DSK3GMQ082PROD with PROPOSALS

FOR FURTHER INFORMATION CONTACT: If permission from the Captain of the Port
Persons with access to the internet you have questions about this proposed Miami or a designated representative.
may obtain the draft guidance at either rulemaking, call or email Petty Officer The Coast Guard will provide notice of
https://www.fda.gov/FoodGuidances or Mara J. Brown, Sector Miami Waterways the regulated area by Broadcast Notice
https://www.regulations.gov. Use the Management Division, U.S. Coast to Mariners and on-scene designated
FDA website listed in the previous Guard; telephone 305–535–4317, email representatives. The regulatory text we
sentence to find the most current Mara.J.Brown@uscg.mil. are proposing appears at the end of this
version of the guidance. SUPPLEMENTARY INFORMATION: document.

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Document Created: 2018-01-25 08:50:34
Document Modified: 2018-01-25 08:50:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notification of availability.
Dates		Submit either electronic or written comments by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.
FR Citation		83 FR 3449

83 FR 3449 - Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 17 (January 25, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration