[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Proposed Rules]
[Pages 3443-3445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2017-D-6592]


Application of the Foreign Supplier Verification Program 
Regulation to Importers of Grain Raw Agricultural Commodities: 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, we, or Agency) is 
announcing the availability of a guidance for industry entitled 
``Application of the Foreign Supplier Verification Program Regulation 
to Importers of Grain Raw Agricultural Commodities: Guidance for 
Industry.'' This guidance is intended to explain our intent to exercise 
enforcement discretion for importers of grain raw agricultural 
commodities (RACs) that are solely engaged in the storage of grain 
intended for further distribution or processing and grain importers 
that do not take physical possession of the grain they import, but 
instead arrange for the delivery of the grain to others for storage, 
packing, or manufacturing/processing.

[[Page 3444]]


DATES: The announcement of the guidance is published in the Federal 
Register on January 25, 2018.

ADDRESSES: You may submit either electronic or written comments on FDA 
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-2017-D-6592 for ``Application of the Foreign Supplier Verification 
Program Regulation to Importers of Grain Raw Agricultural Commodities: 
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 Office 
of Food Safety, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration (HFS-300), 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: Sharon Mayl, Office of Foods and 
Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993-0002, 301-796-4719.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Application of the Foreign Supplier Verification Program 
Regulation to Importers of Grain Raw Agricultural Commodities: Guidance 
for Industry.'' We are issuing the guidance consistent with our good 
guidance practices regulation Sec.  10.115 (21 CFR 10.115). 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. We made this determination because this 
guidance document provides information pertaining to regulations with 
which many importers were required to comply as of May 30, 2017, and it 
sets out compliance policy that reduces regulatory burdens for 
importers of certain raw agricultural commodities. Although the 
guidance document is immediately in effect, we invite comments at any 
time in accordance with the Agency's good guidance practices (Sec.  
10.115(g)(3)).
    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 alternate approach if it satisfies 
the requirements of the applicable statutes and regulations. This 
guidance is not subject to Executive Order 12866.
    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 
enables FDA to better protect public health by helping to ensure the 
safety and security of the food supply. It amended the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) to add, among other food safety 
requirements, provisions requiring the verification of the safety of 
food imported from foreign suppliers of that food.
    Section 805(c) of the FD&C Act (21 U.S.C. 384a(c)) directs FDA to 
issue regulations on the content of Foreign Supplier Verification 
Programs (FSVPs). We issued the FSVP final rule on November 27, 2015 
(80 FR 74225). The FSVP regulation requires food importers to develop, 
maintain, and follow an FSVP that provides adequate assurances that the 
foreign supplier uses processes and procedures that provide the same 
level of public health protection as those required under the 
preventive controls and produce safety provisions of FSMA (if 
applicable) and regulations implementing those provisions, as well as 
assurances that the imported food is not adulterated and that human 
food is not misbranded with respect to allergen labeling.

[[Page 3445]]

    FSMA also includes provisions requiring certain food facilities to 
implement preventive controls to, among other things, provide 
assurances that hazards identified in a hazard analysis will be 
significantly minimized or prevented. FDA's final rules on current good 
manufacturing practice, hazard analysis, and risk-based preventive 
controls for human food (80 FR 55908, September 17, 2015) and for 
animal food (80 FR 56170, September 17, 2015) include provisions 
requiring receiving facilities to conduct a hazard analysis and to 
establish and implement supply-chain programs for domestic and imported 
raw materials and other ingredients for which the facility has 
identified a hazard requiring a supply-chain applied control.
    The preventive controls requirements, including the supply-chain 
program provisions, do not apply to facilities that are solely engaged 
in the storage of non-produce RACs (including grain RACs) intended for 
further distribution or processing. However, the FSVP regulation 
applies to all importers of non-produce RACs, including importers that 
are solely engaged in the storage of these RACs intended for further 
processing.
    The guidance describes FDA's current thinking on the application of 
the FSVP regulation to importers of grain RACs. To better align the 
FSVP regulation with the exemption from preventive controls 
requirements for facilities solely engaged in the storage of non-
produce RACs, and because of the nature of the hazards associated with 
grain RACs and how they are generally addressed in the distribution 
chain, we intend to exercise enforcement discretion for importers of 
grain RACs that are solely engaged in the storage of grain intended for 
further distribution or processing with respect to the FSVP regulation. 
This intent to exercise enforcement discretion with respect to FSVP 
also applies to grain importers that do not take physical possession of 
the grain they import but instead arrange for the delivery of the grain 
to others for storage, packing or manufacturing/processing.

II. Paperwork Reduction Act of 1995

    This 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.

III. 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: January 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01298 Filed 1-24-18; 8:45 am]
 BILLING CODE 4164-01-P


