[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Draft Guidance for Industry: Standards for the Growing,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is issuing a draft guidance entitled, ``Draft Guidance for Industry: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for Human Consumption,'' which revises a currently issued draft
guidance entitled ``Compliance with and Recommendations for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(January 23, 2017) (the January 2017 draft guidance).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the January 2017 draft guidance with additional clarifications in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
[[Page 67158]]
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