Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption; and Guidance for Industry: Standards for the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, 67157-67159 [2023-21294]

Download as PDF Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Proposed Rules 67157 ** We based this figure on the average FY 2023 wait times for field offices and hearings office, as well as by averaging both the average FY 2023 wait times for field offices and teleservice centers, based on SSA’s current management information data. *** This figure does not represent actual costs that SSA is imposing on recipients of Social Security payments to complete this application; rather, these are theoretical opportunity costs for the additional time respondents will spend to complete the application. There is no actual charge to respondents to complete the application. SSA submitted a single new Information Collection Request which encompasses revisions to information collections currently under OMB Numbers 0960–0174, 0960–0456, and 0960–0529) to OMB for the approval of the changes due to the proposed rule. After approval at the final rule stage, we will adjust the figures associated with the current OMB numbers for these forms to reflect the new burden. We are soliciting comments on the burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize the burden on respondents, including the use of automated techniques or other forms of information technology. In addition, we are specifically seeking comment on whether you have any questions or suggestions for edits to the forms referenced above in the context of this proposed regulatory change. If you would like to submit comments, please send them to the following locations: Office of Management and Budget, Attn: Desk Officer for SSA, Fax Number: 202–395–6974, Email address: OIRA_ Submission@omb.eop.gov Social Security Administration, OLCA, Attn: Reports Clearance Director, Mail Stop 3253 Altmeyer, 6401 Security Blvd., Baltimore MD 21235, Fax: 410– 966–2830, Email address: OR.Reports.Clearance@ssa.gov You can submit comments until November 28, 2023, which is 60 days after the publication of this notice. However, your comments will be most useful if you send them to SSA by October 30, 2023, which is 30 days after publication. To receive a copy of the OMB clearance package, contact the SSA Reports Clearance Officer using any of the above contact methods. We prefer to receive comments by email or fax. lotter on DSK11XQN23PROD with PROPOSALS1 (Catalog of Federal Domestic Assistance Program No. 96.006, Supplemental Security Income) List of Subjects in 20 CFR Part 416 Administrative practice and procedure, Reporting and recordkeeping requirements, Supplemental Security Income (SSI). The Acting Commissioner of Social Security, Kilolo Kijakazi, Ph.D., M.S.W., having reviewed and approved this document, is delegating the authority to electronically sign this document to Faye I. Lipsky, who is the primary VerDate Sep<11>2014 18:59 Sep 28, 2023 Jkt 259001 Federal Register Liaison for SSA, for purposes of publication in the Federal Register. Faye I. Lipsky, Federal Register Liaison, Office of Legislation and Congressional Affairs, Social Security Administration. For the reasons stated in the preamble, we propose to amend 20 CFR chapter III, part 416, subpt. K, as set forth below: PART 416—SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED 1. The authority citation for subpart K of part 416 continues to read as follows: Authority: Secs. 702(a)(5), 1602, 1611, 1612, 1613, 1614(f), 1621, 1631, and 1633 of the Social Security Act (42 U.S.C. 902(a)(5), 1381a, 1382, 1382a, 1382b, 1382c(f), 1382j, 1383, and 1383b; sec. 211, Pub. L. 93–66, 87 Stat. 154 (42 U.S.C. 1382 note). 2. Amend § 416.1142 by revising paragraphs (a) introductory text and (a)(6) and (7) and adding paragraph (a)(8) to read as follows: ■ § 416.1142 If you live in a public assistance household. (a) Definition. For purposes of our programs, a public assistance household is one in which every member receives some kind of public incomemaintenance payments. These are payments made under— * * * * * (6) State or local government assistance programs based on need (tax credits or refunds are not assistance based on need); (7) U.S. Department of Veterans Affairs programs (those payments based on need); and (8) The Supplemental Nutrition Assistance Program (SNAP). * * * * * [FR Doc. 2023–21550 Filed 9–28–23; 8:45 am] BILLING CODE 4191–02–P Fmt 4702 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 Food and Drug Administration, HHS. ■ Frm 00041 Food and Drug Administration AGENCY: Subpart K—Income PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Sfmt 4702 ACTION: Notification of availability. 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 inprocess 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 SUMMARY: E:\FR\FM\29SEP1.SGM 29SEP1 67158 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Proposed Rules begin work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: lotter on DSK11XQN23PROD with PROPOSALS1 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 VerDate Sep<11>2014 18:59 Sep 28, 2023 Jkt 259001 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-201509-18/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: PO 00000 Frm 00042 Fmt 4702 Sfmt 4702 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 InProcess 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 E:\FR\FM\29SEP1.SGM 29SEP1 lotter on DSK11XQN23PROD with PROPOSALS1 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Proposed Rules (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; VerDate Sep<11>2014 18:59 Sep 28, 2023 Jkt 259001 • 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-regulationfood-and-dietary-supplements/ guidance-documents-regulatoryinformation-topic-food-and-dietarysupplements, https://www.fda.gov/ regulatory-information/search-fdaguidance-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 POSTAL SERVICE 39 CFR Part 111 Ballot Mail Ancillary Service Endorsements Postal ServiceTM. Proposed rule. AGENCY: ACTION: The Postal Service is proposing to amend Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM®) to remove Change Service Requested, Option 1, as an ancillary service endorsement option for Ballot Mail. DATES: Submit comments on or before October 30, 2023. ADDRESSES: Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L’Enfant Plaza SW, Room 4446, Washington, DC 20260–5015. If sending comments by email, include the name and address of the commenter and send to PCFederalRegister@usps.gov, with a subject line of ‘‘Ballot Mail Service Endorsements’’. Faxed comments are not accepted. SUMMARY: PO 00000 Frm 00043 Fmt 4702 Sfmt 4702 67159 Confidentiality All submitted comments and attachments are part of the public record and subject to disclosure. Do not enclose any material in your comments that you consider to be confidential or inappropriate for public disclosure. You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L’Enfant Plaza SW, 11th Floor North, Washington, DC 20260. These records are available for review on Monday through Friday, 9 a.m.–4 p.m., by calling 202–268–2906. FOR FURTHER INFORMATION CONTACT: Emily Matyas (202) 826–7157 or Garry Rodriguez at (202) 268–7281. SUPPLEMENTARY INFORMATION: Ancillary service endorsements provide an option for mailers to instruct the Postal Service on how to treat their mail if it is determined to be undeliverable-asaddressed and to request address correction services. The Postal Service is proposing to revise subsections 507.1.5.1 and 507.1.5.3 to remove the ‘‘Change Service Requested’’, Option1, ancillary service endorsement as an option for Ballot Mail items. Change Service Requested, Option 1 permits all mailpieces that are undeliverable as addressed to be disposed of and an address correction notice with reason for non-delivery is provided to the mailer. The Election and Government Mail Services group made the policy decision to never allow any identifiable Ballot Mail piece that is undeliverable as addressed to be disposed of by the Postal Service. Instead, Ballot Mail that is undeliverable as addressed must be forwarded to the voter if a Change of Address notice is on file or returned to the election office that sent the Ballot Mail. The Postal Service is proposing to implement this change effective January 21, 2024. We believe this proposed revision will provide customers with a more efficient mailing experience. Although exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), the Postal Service invites public comment on the following proposed revisions to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1. We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes. E:\FR\FM\29SEP1.SGM 29SEP1

Agencies

[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]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.