[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]


-----------------------------------------------------------------------

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Humans and Animals; Draft Guidance for Industry; Availability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.

-----------------------------------------------------------------------

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announcing the availability of a draft guidance for industry entitled 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 The draft guidance, once finalized, will provide 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DATES: Submit either electronic or written comments on the draft 
guidance by May 25, 2018 to ensure that the Agency considers your 
comments on this draft guidance before it completes a final version of 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