[Federal Register Volume 84, Number 122 (Tuesday, June 25, 2019)]
[Notices]
[Pages 29867-29869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13433]


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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for Sprouting: Draft Guidance for Industry; Availability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 or we) is announcing the 
availability of a draft guidance for industry entitled ``Reducing 
Microbial Food Safety Hazards in the Production of Seed for

[[Page 29868]]

Sprouting.'' The draft guidance document, when finalized, will make the 
sprout seed industry (seed growers, conditioners, packers, holders, 
suppliers, and distributors) aware 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DATES: Submit either electronic or written comments on the draft 
guidance by August 26, 2019 to ensure that FDA considers your comment 
on the draft guidance before it begins work on the final version of the 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-2018-D-4534 for ``Reducing Microbial Food Safety Hazards in the 
Production of Seed for Sprouting: Draft 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.
     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.gpo.gov/fdsys/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.
    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 draft 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 draft 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Reducing Microbial Food Safety Hazards in the Production of 
Seed for Sprouting.'' The draft guidance, when finalized, will make the 
sprout seed industry (seed growers, conditioners, packers, holders, 
suppliers, and distributors) aware 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. In the development of the draft guidance, we considered 
three documents related to food safety and hygienic production of seed 
for sprouting: (1) The Codex Code of Hygienic Practice for Fresh Fruits 
and Vegetables Annex II, Annex for Sprout Production (Ref. 1); (2) the 
International Sprout Growers Association--Institute for Food Safety and 
Health's ``U.S. Sprout Production Best Practices'' (Section 2. Raw 
Material Sourcing) (Ref. 2); and (3) the European Sprouted Seeds 
Association (ESSA) Hygiene Guideline for the Production of Sprouts and 
Seeds for Sprouting (Section 2. Production of Seeds) (Ref. 3). We have 
incorporated aspects of these documents that are consistent with our 
laws and regulations, as well as our existing policies.
    We are issuing the draft guidance consistent with our good guidance 
practice regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our current thinking 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 alternate approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous

[[Page 29869]]

sentence to find the most current version of the guidance.

III. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.
    1. Codex ``Code of Hygienic Practice for Fresh Fruits and 
Vegetables,'' CAC/RCP 53-2003, Annex II, Annex for Sprout Production, 
Revision 2010. Retrieved from https://www.ifsh.iit.edu/sites/ifsh/files/departments/ssa/pdfs/codex2003_053e.pdf.
    2. International Sprout Growers Association--Institute for Food 
Safety and Health's ``U.S. Sprout Production Best Practices'' (Section 
2. Raw Material Sourcing). Retrieved from https://www.ifsh.iit.edu/us-sprout-industry-production-best-practices.
    3. Official Journal of the European Union, ``ESSA Hygiene Guideline 
for the Production of Sprouts and Seeds for Sprouting (2017/(220/03),'' 
(Section 2. Production of Seeds). Retrieved from https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52017XX0708(01)&from=EN.

    Dated: June 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13433 Filed 6-24-19; 8:45 am]
 BILLING CODE 4164-01-P


