Notice2022-10189
Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting; Guidance for Industry; Availability
Primary source
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Published
May 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting." This final guidance is intended to inform the sprout seed industry (seed growers, conditioners, packers, holders, suppliers, and distributors) of FDA's serious concern with the continuing outbreaks of foodborne illness associated with the consumption of raw and lightly cooked sprouts and provide FDA's recommendations to firms throughout the production chain of seed for sprouting.
Full Text
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<title>Federal Register, Volume 87 Issue 94 (Monday, May 16, 2022)</title>
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[Federal Register Volume 87, Number 94 (Monday, May 16, 2022)]
[Notices]
[Pages 29753-29754]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10189]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4534]
Reducing Microbial Food Safety Hazards in the Production of Seed
for Sprouting; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Reducing Microbial Food Safety Hazards in the Production of Seed for
Sprouting.'' This final guidance is intended to inform the sprout seed
industry (seed growers, conditioners, packers, holders, suppliers, and
distributors) of FDA's serious concern with the continuing outbreaks of
foodborne illness associated with the consumption of raw and lightly
cooked sprouts and provide FDA's recommendations to firms throughout
the production chain of seed for sprouting.
DATES: The announcement of the guidance is published in the Federal
Register on May 16, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-4534 for ``Reducing Microbial Food Safety Hazards in the
Production of Seed for Sprouting: Guidance for Industry.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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
[[Page 29754]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 guidance to the
Office of Food 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 guidance.
FOR FURTHER INFORMATION CONTACT: Patricia Homola, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1700; or Lauren Kleinman, Center
for Food Safety and Applied Nutrition, Office of Regulations and Policy
(HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Reducing Microbial Food Safety Hazards in the Production of
Seed for Sprouting.'' This guidance is intended to inform the sprout
seed industry (seed growers, conditioners, packers, holders, suppliers,
and distributors) of our serious concern with the continuing outbreaks
of foodborne illness associated with the consumption of raw and lightly
cooked sprouts and provide our recommendations to firms throughout the
production chain of seed for sprouting. We are issuing the guidance
consistent with our good guidance practices regulation (21 CFR 10.115).
The guidance represents 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 alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
In the Federal Register of June 25, 2019 (84 FR 29867), we
announced a draft guidance for industry and gave interested parties an
opportunity to submit comments by August 26, 2019, for us to consider
before beginning work on the final version of the guidance. We received
10 comments on the draft guidance and have modified the final guidance
where appropriate. Changes to the guidance include the addition of
examples, information about the scope of recommendations pertaining to
cleaning and sanitizing of wet and dry food contact surfaces,
information about testing seed for sprouting, research related to the
source of contamination in sprout-related outbreaks, and updated
recommendations related to proximity of seed growing operations to a
domestic animal raising farm. The guidance announced in this notice
finalizes the draft guidance dated June 2019.
II. Paperwork Reduction Act of 1995
This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in
the previous sentence to find the most current version of the guidance.
Dated: May 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10189 Filed 5-13-22; 8:45 am]
BILLING CODE 4164-01-P
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