[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Rules and Regulations]
[Pages 34508-34510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12109]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2020-D-1386]


Temporary Policy During the COVID-19 Public Health Emergency 
Regarding the Qualified Exemption From the Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption: 
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, Agency, or we) is 
announcing the availability of a final guidance for industry entitled 
``Temporary Policy During the COVID-19 Public Health Emergency 
Regarding the Qualified Exemption from the Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption.'' 
Given the public health emergency presented by COVID-19, this guidance 
document is being implemented without prior public comment because FDA 
has determined that prior public participation is not feasible or 
appropriate, but it remains subject to comment in accordance with the 
Agency's good guidance practices. The guidance communicates the 
Agency's intention to exercise

[[Page 34509]]

enforcement discretion, in the manner described in the guidance, 
regarding sales to qualified end-users when determining eligibility for 
the qualified exemption from the Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption, due to 
disruptions to supply chains, for the duration of the COVID-19 public 
health emergency.

DATES: The announcement of the guidance is published in the Federal 
Register on June 5, 2020.

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:
     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-2020-D-1386 for ``Temporary Policy During the COVID-19 Public 
Health Emergency Regarding the Qualified Exemption from the Standards 
for the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption.'' 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.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 (21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Compliance, Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr. (HFS-607), 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: Samir Assar, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr. 
(HFS-607), College Park, MD 20740, 240-402-1636.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Temporary Policy During the COVID-19 Public Health Emergency 
Regarding the Qualified Exemption from the Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption.'' 
This policy relates to the supply chain disruptions caused by the 
public health emergency related to COVID-19, as declared by the 
Department of Health and Human Services.
    Given this public health emergency, this guidance is being 
implemented without prior public comment because FDA has determined 
that prior public participation for this guidance is not feasible or 
appropriate. This guidance document is being implemented immediately, 
but it remains subject to comment in accordance with the Agency's good 
guidance practices.
    This guidance document concerns flexibility for the eligibility 
criteria for the qualified exemption from the Standards for the 
Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption (part 112 (21 CFR part 112)) due to disruptions to supply 
chains due to COVID-19. A farm is eligible for a qualified exemption 
and associated modified requirements in a calendar year if during the 
previous 3-year period preceding the applicable calendar year, the 
average annual monetary value of food the farm sold directly to 
qualified end-users exceeded the average annual monetary value of the 
food the farm sold to all other buyers during that period, and the 
average annual monetary value of all food the farm sold during the 3-
year period was less than $500,000, adjusted for inflation. In order to 
provide flexibility to affected farms during the COVID-19 public health 
emergency, under the circumstances described in the guidance FDA does 
not intend to enforce the criteria regarding the portion of sales that 
are made to qualified end-users in 2020 (and any subsequent years that 
are affected by the COVID-19 public health emergency). Specifically,

[[Page 34510]]

for farms that either met the criteria for the qualified exemption in 
2020 based on sales that were made in 2017 to 2019, or that did not 
have 3 years of sales prior to 2020, but that met the relevant 
requirements during the years they were in operation prior to 2020, FDA 
does not intend to enforce the criteria regarding the portion of sales 
that are made to qualified end-users in years that are affected by the 
COVID-19 public health emergency. This guidance does not affect the 
status of farms who continue to sell a majority of their food to 
qualified end-users despite COVID-19 supply chain disruptions.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation Sec.  10.115(g)(2). The guidance represents the 
current thinking of FDA on ``Temporary Policy During the COVID-19 
Public Health Emergency Regarding the Qualified Exemption from the 
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of 
information. 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. 3501-3521). The collections of information in 
part 112 have been approved under OMB control number 0910-0816.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/FoodGuidances, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19, 
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 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12109 Filed 6-4-20; 8:45 am]
BILLING CODE 4164-01-P