[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Rules and Regulations]
[Pages 51345-51347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24098]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 117, and 507

[Docket No. FDA-2017-D-5996]


Supply-Chain Program Requirements and Co-Manufacturer Supplier 
Approval and Verification for Human Food and Animal Food: 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 guidance for industry entitled 
``Supply-Chain Program Requirements and Co-Manufacturer Supplier 
Approval and Verification for Human Food and Animal Food.'' The 
guidance announces that we do not intend to take enforcement action 
against a receiving facility that is a co-manufacturer and that is not 
in compliance with certain supply-chain program requirements in the 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food'' and ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals'' regulations (preventive controls regulations) for food 
manufactured for the brand owner, under certain circumstances, until 
November 6, 2019. Furthermore, we do not intend to take enforcement 
action under the Foreign Supplier Verification Programs (FSVP) 
regulation against an importer whose supply-chain program is subject to 
enforcement discretion under the preventive controls regulations until 
November 6, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on November 6, 2017.

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:
     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-5996 for ``Supply-Chain Program Requirements and Co-

[[Page 51346]]

Manufacturer Supplier Approval and Verification for Human Food and 
Animal Food.'' 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 21CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Food Safety, Center for Food Safety and Applied Nutrition 
(HFS-300), 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:
    For questions relating to the guidance as it applies to human food: 
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
240-402-2166.
    For questions relating to the guidance as it applies to animal 
food: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-
402-6246.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Supply-Chain Program Requirements and Co-Manufacturer 
Supplier Approval and Verification for Human Food and Animal Food: 
Guidance for Industry.'' We are issuing this guidance consistent with 
our good guidance practices (GGP) regulation (Sec.  10.115 (21 CFR 
10.115)). We are implementing this guidance without prior public 
comment because we have determined that prior public participation is 
not feasible or appropriate (Sec.  10.115(g)(2)). We made this 
determination because the guidance represents a less burdensome policy 
consistent with the public health. Although this guidance document is 
immediately in effect, it remains subject to comment in accordance with 
FDA's GGP regulation. This guidance is not subject to Executive Order 
12866.
    The guidance is intended for persons who participate in certain 
``co-manufacturing'' agreements in the production of human or animal 
food. By ``co-manufacturing,'' we mean a contractual arrangement 
whereby one party (the brand owner) arranges for a second party (the 
co-manufacturer) to manufacture/process human or animal food on behalf 
of the first party. The guidance concerns three regulations that we 
have established in Title 21 of the Code of Federal Regulations (21 
CFR) as part of our implementation of the FDA Food Safety Modernization 
Act (FSMA; Pub. L. 111-353). (For more information on the Agency's 
implementation of FSMA, see https://www.fda.gov/fsma.) These three 
regulations are part 117 (21 CFR part 117) (published in the Federal 
Register on September 17, 2015, 80 FR 55908), part 507 (21 CFR part 
507) (published in the Federal Register on September 17, 2015, 80 FR 
56170), and the FSVP regulation (published in the Federal Register of 
November 27, 2015, 80 FR 74226). Subpart G of part 117 and subpart E of 
part 507 establish requirements for a supply-chain program for those 
raw materials and other ingredients for which a receiving facility has 
identified a hazard requiring a supply-chain-applied control.
    Under the FSVP regulation, importers are required to develop, 
maintain, and follow a foreign supplier verification program that, 
among other things, provides adequate assurance that foreign suppliers 
are producing food in compliance with processes and procedures that 
provide at least the same level of public health protection as those 
required under section 418 of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 350g) (which authorized the supply-chain 
programs in parts 117 and 507) (see Sec.  1.502(a) (21 CFR 1.502(a)). 
An importer that is a receiving facility subject to section 418 of the 
FD&C Act is deemed to be in compliance with the requirements of the 
FSVP regulation, except the importer identification requirements in 21 
CFR 1.509, if the importer has established and implemented a risk-based 
supply-chain program in compliance with part 117, subpart G or part 
507, subpart E (Sec.  1.502(c)(3)).
    Under the definition of ``receiving facility'' established in parts 
117 and 507, co-manufacturers that are subject to the human food or the 
animal food preventive controls requirements and that manufacture/
process a raw material or other ingredient received from a supplier are 
receiving facilities. Co-manufacturers that are receiving facilities 
that have identified a hazard in a raw material or ingredient requiring 
a supply-chain-applied control are required to approve their suppliers 
for those raw materials or other ingredients. However, the supply-chain 
provisions permit an entity other than the receiving facility (e.g., 
permit the brand owner) to determine, conduct, or both determine and 
conduct, appropriate supplier verification activities, provided that 
the receiving facility documents its review and assessment of the other 
entity's applicable documentation. (See Sec. Sec.  117.415(a)(3) and 
507.115(a)(3).) Specifically, the rules allow for a co-manufacturer to 
base its verification of suppliers on review of adequate documentation 
of the brand owner's supplier verification activities.
    Industry has expressed concerns that the requirements of the 
supply-chain program would require revisions to contracts between brand 
owners and their suppliers to allow brand owners to share certain 
information (e.g., audits of suppliers) with co-manufacturers, and that 
establishing new contracts would take a significant period of time, 
impeding their ability to meet

[[Page 51347]]

compliance dates (Ref. 1). If a contract prevents a co-manufacturer 
from being able to review a brand owner's documentation of supplier 
verification activities, the co-manufacturer would not be able to 
verify suppliers based on its review of that documentation. 
Consequently, the co-manufacturer would need to conduct supplier 
verification activities (e.g., on-site audits) that might otherwise not 
be required.
    To provide time for contracts to be revised to allow co-
manufacturers to review all necessary documentation from the brand 
owner, FDA is announcing that, under certain circumstances and on a 
temporary basis, we do not intend to take enforcement action against a 
receiving facility that is a co-manufacturer, and that is not in 
compliance with certain supply-chain program requirements (Sec. Sec.  
117.410(d) and 117.415(a)(3) or Sec. Sec.  507.110(d) and 
507.115(a)(3)) for food manufactured for the brand owner until November 
6, 2019. Furthermore, we do not intend to take enforcement action under 
the FSVP regulation against an importer who is relying on Sec.  
1.502(c)(3) but whose supply-chain program is subject to enforcement 
discretion regarding Sec. Sec.  117.410(d) and 117.415(a)(3) or 
Sec. Sec.  507.110(d) and 507.115(a)(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 alternative approach if it satisfies 
the requirements of the applicable statues and regulations.

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 part 117 have been approved under OMB 
control number 0910-0751. The collections of information in part 507 
have been approved under OMB control number 0910-0789.

III. Electronic Access

    Persons with access to the internet may obtain the document at 
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/default.htm, 
or https://www.regulations.gov. Use the FDA Web sites listed in the 
previous sentence to find the most current version of the guidance.

IV. Reference

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov.

1. Letter from Grocery Manufacturers Association to Dr. Stephen 
Ostroff, Acting Commissioner of Food and Drugs, February 7, 2017.

    Dated: October 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24098 Filed 11-3-17; 8:45 am]
 BILLING CODE 4164-01-P


