[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Pages 25814-25815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-2131]
Evaluating Alternate Curricula for the 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Draft Guidance for Industry; Availability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: 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availability of a draft guidance for industry entitled ``Evaluating
Alternate Curricula for the Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption.'' The draft
guidance, when finalized, will provide recommendations on the factors
that covered farms should consider if they are selecting an alternate
curriculum training to meet the requirements of the ``Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption'' (Produce Safety Rule) and for educators when developing
or evaluating alternate curricula.
DATES: Submit either electronic or written comments on the draft
guidance by October 2, 2019 to ensure that the Agency considers your
comment on the draft guidance before it begins work on the final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-2019-D-2131 for ``Evaluating Alternate Curricula for the Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption: 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
[[Page 25815]]
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.
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
We are announcing the availability of a draft guidance for industry
entitled ``Evaluating Alternate Curricula for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption: Guidance for
Industry.'' 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.
The Produce Safety Rule established science-based minimum standards
for the safe growing, harvesting, packing, and holding of produce grown
for human consumption. Subpart C of the rule includes the specific
requirements for personnel qualifications and training, including the
requirement for at least one supervisor or responsible party from a
farm to successfully complete food safety training at least equivalent
to that received under the standardized curriculum recognized as
adequate by FDA (Sec. 112.22(c) (21 CFR 112.22(c))). For farms covered
by the Produce Safety Rule, version 1.1 of the standardized curriculum
developed by the Produce Safety Alliance is adequate as the
standardized curriculum in Sec. 112.22(c). The purpose of this draft
guidance is to provide recommendations on the factors that covered
farms should consider if they are using an alternate curriculum
training to satisfy the requirements of Sec. 112.22(c) and for
educators when developing or evaluating alternate curricula.
II. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements 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, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11603 Filed 6-3-19; 8:45 am]
BILLING CODE 4164-01-P