
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Proposed Rules]
[Pages 4803-4805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00819]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2008-D-0096 (Formerly Docket No. 2007D-0494)]


Control of Listeria monocytogenes in Ready-To-Eat Foods: Revised 
Draft Guidance for Industry; Availability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announcing the availability of a revised draft guidance for industry 
entitled ``Control of Listeria monocytogenes in Ready-To-Eat Foods.'' 
The revised draft guidance is intended for any person who is subject to 
our regulation entitled ``Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Human Food'' and who 
manufactures, processes, packs, or holds ready-to-eat (RTE) foods. The 
revised draft guidance is intended to help such persons comply with the 
requirements of that regulation with respect to measures that can 
significantly minimize or prevent the contamination of RTE food with L. 
monocytogenes whenever a RTE food is exposed to the environment prior 
to packaging and the packaged food does not receive a treatment or 
otherwise include a control measure (such as a formulation lethal to L. 
monocytogenes) that would significantly minimize L. monocytogenes.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we issue the final version of the guidance, submit 
either electronic or written comments on the draft guidance by July 26, 
2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2008-D-0096 for ``Control of Listeria monocytogenes in Ready-To-Eat 
Foods.'' 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 Division of Dockets Management 
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

[[Page 4804]]

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 Division of Dockets 
Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the revised draft 
guidance to the 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 revised 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

    We are announcing the availability of a revised draft guidance for 
industry entitled ``Control of Listeria monocytogenes in Ready-To-Eat 
Foods.'' We are issuing the revised draft guidance consistent with our 
good guidance practices regulation (21 CFR 10.115). The revised 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.
    In the Federal Register of February 7, 2008 (73 FR 7293), we made 
available a draft guidance for industry entitled ``Control of Listeria 
monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods'' (the 2008 
draft Listeria guidance). The recommendations in the 2008 draft 
Listeria guidance were intended to complement the requirements in a 
regulation entitled ``Current Good Manufacturing Practice in 
Manufacturing, Packing, or Holding Human Food,'' which had been 
established in part 110 (21 CFR part 110). The recommendations in the 
2008 draft Listeria guidance also were intended to assist processors of 
refrigerated and frozen RTE foods in meeting the requirements in part 
110 with respect to the control of L. monocytogenes. We gave interested 
parties an opportunity to submit comments by April 7, 2008, for us to 
consider before beginning work on the final version of the guidance. We 
received several comments on the 2008 draft Listeria guidance.
    Since issuing the 2008 draft Listeria guidance, we conducted 
rulemaking to amend the current good manufacturing practice (CGMP) 
requirements in part 110 to modernize them and establish them in new 
part 117 (21 CFR part 117), subparts A, B, and F (80 FR 55908, 
September 17, 2015). Part 117 (entitled ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
Food'') also includes new requirements (in subparts A, C, D, E, F, and 
G) for domestic and foreign facilities that are required to register 
under section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 350d) to establish and implement hazard analysis and 
risk-based preventive controls for human food (the human food 
preventive controls requirements). The new human food preventive 
controls requirements are part of our implementation of the FDA Food 
Safety Modernization Act (FSMA; Pub. L. 111-353). We also discussed 
certain recommendations in the 2008 draft Listeria guidance with our 
Food Advisory Committee during a meeting held on December 7 and 8, 2015 
(80 FR 69229, November 9, 2015 and Ref. 1).
    We have revised the 2008 draft Listeria guidance to reflect the 
comments we received on that draft guidance, the amended CGMP 
requirements now established in part 117, the new human food preventive 
controls requirements established in part 117, and the recommendations 
of our Food Advisory Committee (Ref. 2). The revised draft guidance is 
intended to explain our current thinking on procedures and practices to 
help food establishments that are subject to part 117 to: (1) Comply 
with the CGMP requirements of part 117 (e.g., for personnel, buildings 
and facilities, equipment and utensils, and production and process 
controls) during the production of an RTE food that is exposed to the 
environment prior to packaging and the packaged food does not receive a 
treatment or otherwise include a control measure (such as a formulation 
lethal to L. monocytogenes) that would significantly minimize L. 
monocytogenes; and (2) comply with certain human food preventive 
controls requirements regarding environmental pathogens in such RTE 
foods.
    Part 117 defines ``environmental pathogen'' to mean a pathogen 
capable of surviving and persisting within the manufacturing, 
processing, packing, or holding environment such that food may be 
contaminated and may result in foodborne illness if that food is 
consumed without treatment to significantly minimize the environmental 
pathogen (21 CFR 117.3). Within that definition, L. monocytogenes is 
listed as an example of an environmental pathogen. The hazard analysis 
required by part 117 must include an evaluation of environmental 
pathogens whenever an RTE food is exposed to the environment prior to 
packaging and the packaged food does not receive a treatment or 
otherwise include a control measure (such as a formulation lethal to 
the pathogen) that would significantly minimize the pathogen (Sec.  
117.130(c)(1)(ii)). If the hazard analysis identifies L. monocytogenes 
as a hazard requiring a preventive control, the facility must identify 
one or more preventive controls to provide assurances that L. 
monocytogenes will be significantly minimized or prevented in the 
facility's food products and the food manufactured, processed, packed, 
or held by the facility will not be adulterated under section 402 of 
the FD&C Act (Sec.  117.135(a)). In addition, the human food preventive 
controls requirements specify that, as appropriate to the facility, the 
food, and

[[Page 4805]]

the nature of the preventive control and its role in the facility's 
food safety system, the facility must conduct activities that include 
environmental monitoring, for an environmental pathogen or for an 
appropriate indicator organism, if contamination of an RTE food with an 
environmental pathogen is a hazard requiring a preventive control, by 
collecting and testing environmental samples (Sec.  117.165(a)(3)). The 
revised draft guidance includes recommendations for controls to 
significantly minimize or prevent L. monocytogenes in RTE foods, for 
sanitation controls to eliminate L. monocytogenes from the food 
production environment, and for environmental monitoring as 
verification of sanitation controls.

II. Paperwork Reduction Act of 1995

    The revised 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 (the PRA) (44 
U.S.C. 3501-3520). The collections of information in part 117 have been 
approved under OMB Control No. 0910-0751.
    FDA tentatively concludes that the revised draft guidance also 
contains proposed information collection provisions that are subject to 
review by OMB under the PRA but are not included in the information 
collection approved under OMB Control No. 0910-0751. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes Agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal Agencies to provide a 60-day notice in the Federal Register for 
each proposed collection of information before submitting the 
collection to OMB for approval. To comply with this requirement, we 
will publish a 60-day notice on the proposed collection of information 
in a future issue of the Federal Register.

III. Electronic Access

    Persons with access to the Internet may obtain the revised draft 
guidance at either http://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

IV. References

    The following references are on display at the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA. 2015. Food Advisory Committee Meeting, Charge and Questions. 
Topic: Addressing Listeria monocytogenes in Ready-To-Eat Foods, 
December 7-8, 2015. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/UCM472842.pdf.
2. FDA. 2015. Food Advisory Committee (FAC) Recommendations. Topic: 
Addressing Listeria monocytogenes in Ready-To-Eat Foods, December 7-
8, 2015. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/UCM476521.pdf.

    Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00819 Filed 1-13-17; 8:45 am]
 BILLING CODE 4164-01-P


