[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Proposed Rules]
[Pages 3445-3446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01297]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2017-D-5225]
Foreign Supplier Verification Programs for Importers of Food for
Humans and Animals; Draft Guidance for Industry; Availability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announcing the availability of a draft guidance for industry entitled
``Foreign Supplier Verification Programs for Importers of Food for
Humans and Animals.'' The draft guidance, once finalized, will provide
our thinking on how importers of human or animal food can comply with
the regulation on foreign supplier verification programs (FSVPs) issued
on November 27, 2015.
DATES: Submit either electronic or written comments on the draft
guidance by May 25, 2018 to ensure that the Agency considers your
comments on this draft guidance before it completes a final version of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-2017-D-5225 for ``Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals: 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
[[Page 3446]]
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 Outreach and Information Center (HFS-009), Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740. 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: Mischelle B. Ledet, Office of
Compliance (HFS-600), Center for Food Safety and Applied Nutrition,
5001 Campus Dr., College Park, MD 20740, 240-701-5986.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 27, 2015 (80 FR 74226), we
issued a final rule adopting a regulation on foreign supplier
verification programs (FSVPs) for importers of food for humans and
animals (FSVP final rule). The FSVP final rule implements section 301
of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353),
which enables the Agency to better protect public health by helping to
ensure the safety and security of the food supply.
Section 301 of FSMA added section 805 to the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) to require persons who
import food into the United States to perform risk-based foreign
supplier verification activities. In addition to directing FDA to issue
regulations on the content of FSVPs, section 805 directs FDA to issue
guidance to assist importers in developing FSVPs.
In accordance with section 805 of the FD&C Act, we are announcing
the availability of a draft guidance for industry entitled ``Foreign
Supplier Verification Programs for Importers of Food for Humans and
Animals.'' The draft guidance, once finalized, will provide our
thinking on how to comply with the FSVP regulation, including, but not
limited to, requirements to analyze the hazards in food, evaluate a
potential foreign supplier's performance and the risk posed by a food,
and determine and conduct appropriate foreign supplier verification
activities. The draft guidance also addresses how importers can meet
the modified FSVP requirements for importers of dietary supplements,
very small importers, importers of food from certain small foreign
suppliers, and importers of food from countries whose food safety
systems we have officially recognized as comparable or determined to be
equivalent to that of the United States.
The draft guidance reflects interpretations regarding two matters
addressed in the preamble to the FSVP final rule that differ from the
interpretations expressed there. First, the draft guidance reflects an
interpretation that is different from our statement in the preamble to
the FSVP final rule that waxing and cooling raw agricultural
commodities, when done by a packing operation for purposes of storage
or transport, may be considered a packing activity (see 80 FR 74226 at
74236 (Comment/Response 14)). Instead, the draft guidance states that
such activities may be packing activities and/or holding activities,
depending on the circumstances. This change reflects our revised
thinking regarding the classification of waxing, which we now consider
may be incidental to holding (not packing) under certain circumstances
(see ``Classification of Activities as Harvesting, Packing, Holding, or
Manufacturing/Processing for Farms and Facilities: Draft Guidance for
Industry'' (81 FR 58421, August 25, 2016) available at: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM517575.pdf). Second, the
draft guidance reflects an interpretation that differs from our
statement in the preamble to the FSVP final rule that there may be
circumstances in which hazards that may be intentionally introduced by
acts of terrorism may present a known or reasonably foreseeable hazard,
such that importers may need to address these hazards as part of their
supplier verification activities (see 80 FR 74226 at 74281 (Comment/
Response 174)). That statement assumed that importers would consider
such hazards in their hazard analyses. In the draft guidance, we
clarify that importers are not required under the FSVP regulation to
consider in their hazard analysis hazards that are intentionally
introduced to cause wide scale public health harm. Instead, importers
should consider warning letters or other enforcement action taken by
FDA against foreign suppliers for violation of FDA's regulation on
intentional adulteration (in 21 CFR part 121) as part of their
evaluation of potential suppliers under 21 CFR 1.505 in the FSVP
regulation. Our prior statements were incorrect and we hereby withdraw
them. We further explain our thinking on these matters in the FSVP
draft guidance.
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
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 may use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This draft guidance is not subject to Executive Order 12866.
III. 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 1, subpart L, have been
approved under OMB control number 0910-0752.
IV. 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 draft guidance.
Dated: January 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01297 Filed 1-24-18; 8:45 am]
BILLING CODE 4164-01-P