[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Proposed Rules]
[Pages 53197-53199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2018-D-3583]


Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft 
Guidance for Industry; Availability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announcing the availability of a draft guidance for industry entitled 
``Guide to Minimize Food Safety Hazards of Fresh-cut Produce.'' The 
draft guidance, when finalized, will supersede a previous guidance, 
entitled ``Guide to Minimize Microbial Food Safety Hazards of Fresh-cut 
Fruits and Vegetables,'' that we issued in 2008. The draft guidance is 
intended to explain our current thinking on how to comply with recently 
modernized requirements for current good manufacturing practice (CGMP) 
and with new requirements for hazard analysis and risk-based preventive 
controls under our regulation entitled ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
Food'' during the production of fresh-cut produce.

DATES: Submit either electronic or written comments on the draft 
guidance by April 22, 2019 to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 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

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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-2018-D-3583 for ``Guide to Minimize Food Safety Hazards of Fresh-
cut Produce: 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.gpo.gov/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 
the Office of Food Safety, Division of Produce Safety, 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 request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Insook Son, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1648.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Guide to Minimize Food Safety Hazards of Fresh-cut 
Produce.'' 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. This guidance 
is not subject to Executive Order 12866.
    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).
    In 2008, we issued a guidance for industry entitled ``Guide to 
Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and 
Vegetables.'' Fresh-cut fruits and vegetables mean any fresh fruit or 
vegetable or combination thereof that has been physically altered from 
its whole state after being harvested from the field (e.g., by 
chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or 
tearing) without additional processing (such as blanching or cooking). 
That guidance was intended for all fresh-cut produce processing firms 
to enhance the safety of fresh-cut produce by minimizing the microbial 
food safety hazards. It explained our thinking on how to comply with 
CGMP requirements that then were established in a regulation entitled 
``Current Good Manufacturing Practice in Manufacturing, Packing, or 
Holding Human Food'' (21 CFR part 110).
    In the Federal Register of September 17, 2015 (80 FR 55908), we 
published a final rule that, among other things, modernized the CGMP 
requirements and established them in new 21 CFR part 117 (part 117), 
entitled ``Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Human Food.'' Part 117 also includes 
new requirements for hazard analysis and risk-based preventive controls 
for establishments that are required to register as food facilities. 
The draft guidance that we are making available for public comment is 
intended to explain our current thinking on how all food establishments 
that produce fresh-cut produce can comply with the modernized CGMP 
requirements in part 117. The draft guidance also is intended to 
explain our current thinking on how fresh-cut produce food facilities 
that are subject to the new requirements for hazard analysis and risk-
based preventive controls can comply with those requirements.

II. 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

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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.

III. 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: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23005 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P