[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Rules and Regulations]
[Pages 11644-11646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05953]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2019-D-1266]


Produce Safety Rule: Enforcement Policy for Entities Growing, 
Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and 
Almonds; 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 an immediately in effect guidance for industry entitled 
``Produce Safety Rule: Enforcement Policy for Entities Growing, 
Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and 
Almonds.'' This document states the intent of FDA to exercise 
enforcement discretion regarding the requirements of the ``Standards 
for the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption'' regulation (Produce Safety Regulation) as they apply to 
entities growing, harvesting, packing, and holding hops, wine grapes, 
pulse crops, and almonds.

DATES: The announcement of the guidance is published in the Federal 
Register on March 28, 2019.

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:

[[Page 11645]]

     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-2019-D-1266 for ``Produce Safety Rule: Enforcement Policy for 
Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, 
Pulse Crops, and Almonds: 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 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 guidance.

FOR FURTHER INFORMATION CONTACT: Fazila Shakir, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1355.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Produce Safety Rule: Enforcement Policy for Entities 
Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse 
Crops, and Almonds.'' 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 accordance 
with Sec.  10.115(g)(2), we are implementing the guidance immediately 
because we have determined that prior public participation is not 
feasible or appropriate. Although the guidance document is immediately 
in effect, FDA will accept comments at any time. The guidance is not 
subject to Executive Order 12866.
    The FDA Food Safety Modernization Act (Pub. L. 111-353) directs FDA 
to better protect public health by, among other things, adopting a 
modern, preventive, and risk-based approach to food safety. The Produce 
Safety Regulation is a set of science-based minimum standards for the 
safe growing, harvesting, packing, and holding of fruits and vegetables 
grown for human consumption. Produce is subject to the Produce Safety 
Regulation unless it is ``not covered'' or is eligible for an 
exemption. Produce that is not covered by the Produce Safety Regulation 
includes that which is rarely consumed raw (21 CFR 112.2(a)(1)), 
produced for personal or on-farm consumption (21 CFR 112.2(a)(2)), or 
not a raw agricultural commodity (21 CFR 112.2(a)(3)).
    Following the publication of the final rule establishing the 
Produce Safety Regulation, FDA received feedback from some stakeholders 
that certain covered commodities--hops, wine grapes, pulse crops, and 
almonds--should be exempt from the requirements of the Produce Safety 
Regulation. After conducting an initial review of how hops, wine 
grapes, pulse crops, and almonds are grown, harvested, packed, held, 
and used, FDA has decided to exercise enforcement discretion with 
respect to the Produce Safety Regulation for entities growing, 
harvesting, packing, or holding those commodities while we consider 
pursuing rulemaking to address the unique circumstances they each 
present. This means that we will not expect entities growing, 
harvesting, packing, or holding these commodities to meet any of the 
Produce Safety Regulation requirements with respect to these 
commodities.
    We will consider revising our intent to exercise enforcement 
discretion if, for example, new information becomes available regarding 
safety concerns associated with the production and consumption of these 
commodities.

[[Page 11646]]

II. Electronic Access

    Persons with access to the internet may obtain the 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: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05953 Filed 3-27-19; 8:45 am]
BILLING CODE 4164-01-P