[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Proposed Rules]
[Pages 7751-7753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11, 16, and 112

[Docket No. FDA-2017-D-0175]


Compliance With and Recommendations for Implementation of the 
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption for Sprout Operations; Draft Guidance for 
Industry; 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availability of a draft guidance for industry entitled ``Compliance 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.'' The draft guidance, when 
finalized, 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), and 
primarily focuses on assisting such operations in complying with the 
sprout-specific requirements in Subpart M (Sprouts) of the Produce 
Safety Rule. The draft guidance also includes limited discussion on 
certain other applicable requirements of the Produce Safety Rule. This 
draft guidance may also be useful to sprout operations that are not 
subject to the Produce Safety Rule that voluntarily choose to follow 
the standards established by the rule.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 24, 2017.

[[Page 7752]]


ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Compliance with and Recommendations for 
Implementation of the Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption for Sprout Operations.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the 
Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance 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 one self-addressed adhesive 
label to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
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 ``Compliance with and Recommendations for Implementation of 
the Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption for Sprout Operations.'' We are issuing 
the draft guidance consistent with our good guidance practices 
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 alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.
    The draft guidance for industry is intended to explain our current 
thinking on how to comply with the requirements for the safe growing, 
harvesting, packing and holding of produce under 21 CFR part 112, 
focusing on subparts impacting sprout operations covered by Subpart M. 
Topics discussed in the draft guidance include:
     General Sprout Production;
     Buildings, Tools, and Equipment;
     Cleaning and Sanitizing;
     Agricultural Water in Sprouting Operations;
     Seeds for Sprouting;
     Sampling and Testing of Spent Sprout Irrigation Water or 
Sprouts;
     Environmental Monitoring; and
     Recordkeeping.
    FDA welcomes comments on any aspect of this draft guidance. We are 
particularly interested in receiving information about the types of 
seed or bean treatments that have been used by sprout operations and/or 
seed suppliers, as well as their feasibility of use, cost, impact on 
germination; scientific information related to the effectiveness in 
reducing or eliminating microorganisms of public health significance; 
and any variability in treatment effectiveness based on seed type.
    FDA has developed a risk assessment model to evaluate the public 
health impact of seed treatment and testing of spent irrigation water 
in a sprout production system and anticipates making it available in 
the near future, following peer review.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the

[[Page 7753]]

public submit reports, keep records, or provide information to a third 
party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to publish notice in the Federal Register 
soliciting public comment on each proposed collection of information 
before submitting the collection to OMB for approval. To comply with 
this requirement, we will publish a 60-day notice on the proposed 
collection of information in a future issue of the Federal Register.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01128 Filed 1-19-17; 8:45 am]
 BILLING CODE 4164-01-P