[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Proposed Rules]
[Pages 53196-53197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23006]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2018-D-3631]


Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption; Draft Guidance for Industry; 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, the Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption.'' The draft guidance, when finalized, 
will provide FDA's current thinking and recommendations to help covered 
farms comply with the final regulation entitled ``Standards for the 
Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption'' (Produce Safety Rule), which established science-based 
minimum standards for the safe growing, harvesting, packing, and 
holding of produce grown for human consumption.

DATES: Submit either electronic or written comments on the draft 
guidance by April 22, 2019 to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 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-3631 for ``Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption; 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 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.

[[Page 53197]]


FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1636.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Standards for the Growing, Harvesting, Packing, and Holding 
of Produce for Human Consumption.'' We are issuing the draft guidance 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The draft guidance, when finalized, will represent 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 alternate 
approach if it satisfies the requirements of the applicable statutes 
and regulations. This guidance is not subject to Executive Order 12866.
    We intend to conduct four public meetings in diverse regions of the 
United States to discuss the draft guidance, and we will provide 
details about these public meetings in a notice published in the 
Federal Register.
    The Produce Safety Rule (80 FR 74353) established science-based 
minimum standards for the safe growing, harvesting, packing, and 
holding of produce grown for human consumption. The rule sets forth 
procedures, processes, and practices that minimize the risk of serious 
adverse health consequences or death, including those reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable biological hazards into or onto produce and to provide 
reasonable assurances that the produce is not adulterated on account of 
such hazards. Requirements of the rule focus on major routes of 
contamination, including health and hygiene; biological soil amendments 
of animal origin; domesticated and wild animals; and equipment, tools, 
and buildings.
    This draft guidance provides recommendations, examples, and 
information related to compliance and implementation of the following 
subparts of the Produce Safety Rule:
    Subpart A--General Provisions
    Subpart C--Personnel Qualifications and Training
    Subpart D--Health and Hygiene
    Subpart F--Biological Soil Amendments of Animal Origin and Human 
Waste
    Subpart I--Domesticated and Wild Animals
    Subpart K--Growing, Harvesting, Packing, and Holding Activities
    Subpart L--Equipment, Tools, Buildings, and Sanitation
    Subpart O--Records
    Subpart P--Variances

    This draft guidance is based on FDA's current thinking and we 
believe that additional information would assist us in developing the 
final guidance. While we invite comments on all aspects of the draft 
guidance, we seek specific comments, information, and data on the 
following:
    For equipment and tools intended to or likely to contact covered 
produce:
     When acquiring equipment and tools, how do you engage with 
equipment and tool suppliers about the size, design, and construction 
of your buildings so that they can accommodate the equipment and tools?
     What information or data can you provide about cleaning, 
sanitizing, and maintenance practices and procedures for equipment and 
tools that have wood, foam, or other porous or absorbent materials?
    For domesticated and wild animals:
     What data or information can you provide about factors or 
conditions that would affect the likelihood of contamination of covered 
produce by animals? Such factors include, for example, historical 
information and conditions on or near farms that influence animal 
habitats.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 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 draft guidance 
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23006 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P


