[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Proposed Rules]
[Pages 67157-67159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2017-D-0175]


Draft Guidance for Industry: Standards for the Growing, 
Harvesting, Packing, and Holding of Sprouts for Human Consumption; and 
Guidance for Industry: Standards for the Growing, Harvesting, Packing, 
and Holding of Sprouts for Human Consumption; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of two guidance documents that will help sprout operations 
subject to FDA's final rule entitled ``Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption'' 
(the Produce Safety Rule) understand the topics covered in the Produce 
Safety Rule pertaining to personnel qualifications, training, and 
hygienic practices; equipment, tools, and buildings; and sampling and 
testing of spent sprout irrigation water (or in-process sprouts). FDA 
is issuing a draft guidance entitled, ``Draft Guidance for Industry: 
Standards for the Growing, Harvesting, Packing, and Holding of Sprouts 
for Human Consumption,'' which revises a currently issued draft 
guidance entitled ``Compliance with and Recommendations for 
Implementation of the Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption for Sprout Operations'' 
(January 23, 2017) (the January 2017 draft guidance). In addition, FDA 
is announcing the availability of a final guidance entitled ``Guidance 
for Industry: Standards for the Growing, Harvesting, Packing, and 
Holding of Sprouts for Human Consumption,'' which finalizes portions of 
the January 2017 draft guidance with additional clarifications in 
response to comments.

DATES: Submit either electronic or written comments on the draft 
revised guidance by March 27, 2024 to ensure that FDA considers your 
comment on the draft revised guidance before we

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begin 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-2017-D-0175 for ``Draft Guidance for Industry: Standards for the 
Growing Harvesting, Packing, and Holding of Sprouts for Human 
Consumption.'' 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, 240-402-7500.
     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.'' We will review 
this copy, including the claimed confidential information, in our 
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.govinfo.gov/content/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, 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 revised draft 
guidance document to the Division of Produce Safety, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1600. Send two self-
addressed adhesive labels to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety 
and Applied Nutrition (HFS-317), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740-3835, 240-402-1636.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Draft Guidance for Industry: Standards for the Growing, 
Harvesting, Packing, and Holding of Sprouts for Human Consumption.'' 
The draft guidance is a revision of the January 2017 draft guidance 
entitled ``Draft Guidance for Industry: Compliance with and 
Recommendations for Implementation of the Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption for 
Sprout Operations'' and contains revised information in the sections 
entitled ``Equipment, Tools and Buildings'' (titled ``Buildings, Tools 
and Equipment'' in the January 2017 draft guidance) and ``Sampling and 
Testing of Spent Sprout Irrigation Water (or In-Process sprouts)'' 
(sections IV and V, respectively, which were sections IV and VIII in 
the January 2017 draft guidance) and consolidates information on 
personnel qualifications, training, and hygienic practices into a new 
standalone section. FDA is also issuing a final guidance entitled 
``Guidance for Industry: Standards for the Growing, Harvesting, 
Packing, and Holding of Sprouts for Human Consumption,'' that finalizes 
recommendations from the January 2017 draft guidance with additional 
clarifications in response to comments. Additionally, we have revised 
the titles of both the draft guidance and final guidance to make them 
more concise and to promote clarity.
    We are issuing these guidance documents consistent with our good 
guidance practices regulation (21 CFR 10.115). The guidance documents 
do not establish any rights for any person and are not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    In the Federal Register of January 23, 2017 (82 FR 7751), we made 
available the 2017 draft guidance and gave interested parties an 
opportunity to submit comments by July 24, 2017, for us to consider 
before beginning work on the final version of the guidance. We received 
several comments on the January 2017 draft guidance, and we address 
those comments in the final guidance.
    We are issuing revised sections of the January 2017 draft guidance 
for additional comment in the draft guidance. The draft guidance 
includes revised sections on ``Equipment, Tools and Buildings,'' and 
``Sampling and Testing of Spent Sprout Irrigation Water

[[Page 67159]]

(or In-Process Sprouts)'', and a new section entitled ``Personnel 
Qualifications, Training, and Hygienic Practices.'' We are issuing 
these sections for additional comment for the following reasons:
     Equipment, Tools and Buildings: This section has been 
revised to facilitate alignment with the recommendations in related 
guidances.
     Sampling and Testing of Spent Sprout Irrigation Water (or 
In-Process Sprouts): We are reissuing this section in draft to receive 
additional comments and feedback from sprouting operations, which will 
inform ongoing FDA research on this topic.
     Personnel Qualifications, Training, and Hygienic 
Practices: In the January 2017 draft guidance, many of the 
recommendations for personnel qualifications, training, and hygienic 
practices were dispersed throughout, rather than being consolidated in 
a single section. In the draft guidance, the recommendations are 
consolidated into a standalone section entitled ``Personnel 
Qualifications, Training, and Hygienic Practices'' to ensure that we 
present the recommendations comprehensively and to facilitate ease of 
reading.
    We welcome comments on any aspect of the draft guidance. We are 
particularly interested in receiving information about any testing of 
spent sprout irrigation water or in-process sprouts that sprout 
operations are currently doing for non-O157 Shiga toxin-producing 
Escherichia coli (STEC), including test kit names (as applicable).
    We are finalizing other sections of the January 2017 draft guidance 
with minor revisions. Changes to the final guidance include: clarifying 
the recommendations regarding the frequency of cleaning and sanitizing; 
providing additional recommendations on seed for sprouting, including 
seed treatment and corrective actions; removing language on voluntary 
periodic sampling and testing of sprouts, and clarifying our 
expectations for corrective actions after an operation detects Listeria 
spp. or Listeria monocytogenes in an environmental sample. We also 
received general comments that requested we shorten and simplify the 
guidance. As a result, we removed section III (``General Sprout 
Production,'' as it appeared in the January 2017 draft guidance) 
because most of the language in this section was repeated elsewhere. We 
also made editorial changes to improve clarity and removed certain 
recommendations based on impracticality. The final guidance consists of 
the following sections:
     Cleaning and Sanitizing;
     Agricultural Water in Sprouting Operations;
     Seeds for Sprouting;
     Environmental Monitoring; and
     Recordkeeping.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in 21 CFR part 112 have been approved under 
OMB control number 0910-0816.

III. Electronic Access

    Persons with access to the internet may obtain the guidances at 
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA 
website listed in the previous sentence to find the most current 
version of the guidance.

    Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21294 Filed 9-28-23; 8:45 am]
BILLING CODE 4164-01-P