[Federal Register Volume 87, Number 94 (Monday, May 16, 2022)]
[Notices]
[Pages 29753-29754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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.
    <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 https://www.regulations.gov 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 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 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 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: May 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10189 Filed 5-13-22; 8:45 am]
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