Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Supply-Chain Program Requirements
and Co-Manufacturer Supplier Approval
and Verification for Human Food and
Animal Food: Guidance for Industry
Additional copies are available from:
Office of Food Safety HFS-300
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
(Tel) 240-402-2166
or
Center for Veterinary Medicine HFV-200
Food and Drug Administration
7519 Standish Place
Rockville, MD 20855
(Tel) 240-402-6246
http://www.fda.gov/FoodGuidances
You may submit electronic or written comments regarding this guidance at any time. Submit
electronic comments to https://www.regulations.gov. Submit written comments on the
guidance to the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified
with the Docket No. FDA-2017-D-5996.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
November 2017

Contains Nonbinding Recommendations
Table of Contents
I. 	Introduction
II. 	Background
III. 	Discussion
IV. 	References

Contains Nonbinding Recommendations
1
Supply-Chain Program Requirements
and Co-Manufacturer Supplier Approval
and Verification for Human Food and
Animal Food: Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA, the
Agency, or we) 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 statutes and regulations. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.
I. 	Introduction
This 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.
FDA has established requirements for a supply-chain program for raw materials and other
ingredients for which a receiving facility has identified a hazard requiring a supply-chain-applied
control in two regulations. The first regulation, which we established in 21 CFR part 117, is
entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food” (“part 117”). The second regulation, which we established in 21 CFR
part 507, is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Food for Animals” (“part 507”). Also, in our regulation entitled “Foreign
Supplier Verification Programs for Importers of Food for Humans and Animals” (FSVP
regulation; established in 21 CFR part 1, subpart L) we established that an importer that is a
receiving facility is deemed to be in compliance with most of the requirements of the FSVP
regulation for a food it imports, as long as the importer is in compliance with the supply-chain
program requirements of part 117 or part 507 rule for that food. When an importer that is a
receiving facility is in compliance with the supply-chain program requirements, the only
1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition
in cooperation with the Center for Veterinary Medicine and Office of Regulatory Affairs at the U.S. Food and Drug
Administration.

Contains Nonbinding Recommendations
2
requirement of the FSVP regulation that applies is the requirement for importer identification at
entry (21 CFR 1.509). 	Current industry co-manufacturing arrangements may include a supply-
chain program established and implemented by the brand owner, the co-manufacturer, or both.
This guidance advises such persons of specific circumstances in which FDA does not intend to
take enforcement action regarding a co-manufacturer’s compliance with the supply-chain
program requirements.
Not all co-manufacturers are required to have supply-chain programs. If there are no hazards
requiring supply-chain-applied controls in the raw materials and other ingredients used by a co-
manufacturer, then the co-manufacturer does not need a supply-chain program, and this guidance
is not applicable. This guidance is applicable when the brand owner approves and specifies to
the co-manufacturer which suppliers must be used and there is a hazard that requires a supply-
chain-applied control. Note, the brand owner is not considered the supplier of the co-
manufacturer under the regulations if the brand owner does not manufacture/process the food,
raise the animal, or grow the food that is provided to the co-manufacturer.
We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21
CFR 10.115). This guidance is immediately effective because FDA has determined that prior
public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe our current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The use of the word should in FDA guidances means that something is suggested or
recommended, but not required.
II. 	Background
This 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).2 These three regulations are part 117 (published
in the Federal Register on September 17, 2015, 80 FR 55907), part 507 (published in the
Federal Register on September 17, 2015, 80 FR 51670), and the FSVP regulation (published in
the Federal Register of November 27, 2015, 80 FR 74226). Subparts A, B, and F of part 117
include current good manufacturing practice (CGMP) requirements for manufacturing, packing,
or holding human food. Subparts A, C, D, E, F, and G of part 117 include requirements for
domestic and foreign facilities that are required to register under section 415 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) to conduct a hazard analysis and
implement risk-based preventive controls for human food (the human food preventive controls
requirements). Subpart G of part 117 establishes 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.
2 For more information on the Agency’s implementation of FSMA, see http://www.fda.gov/fsma.

Contains Nonbinding Recommendations
3
Part 117 defines a “receiving facility” as a facility that is subject to the human food preventive
controls requirements and that manufactures/processes a raw material or other ingredient that it
receives from a supplier. Part 117 defines a “supplier” as the establishment that
manufactures/processes the food, raises the animal, or grows the food that is provided to a
receiving facility without further manufacturing/processing by another establishment, except for
further manufacturing/processing that consists solely of the addition of labeling or similar
activity of a de minimis nature. Part 117 defines a “supply-chain-applied control” as a preventive
control for a hazard in a raw material or other ingredient when the hazard in the raw material or
other ingredient is controlled before its receipt.
For domestic and foreign facilities that are required to register, subparts A, B, and F of part 507
include CGMP requirements and subparts A, C, D, E, and F of part 507 include requirements to
conduct a hazard analysis and implement risk-based preventive controls for animal food (the
animal food preventive controls requirements). Subpart E of part 507 establishes requirements
for a supply-chain program for raw materials and other ingredients for which a receiving facility
has identified a hazard requiring a supply-chain-applied control. The provisions and
applicability of part 507, subpart E, and the definitions established in part 507 for “receiving
facility,” “supplier,” and “supply-chain-applied control” are analogous to those of part 117.
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 FD&C Act
(which authorized the supply-chain programs in 21 CFR parts 117 and 507) (see 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 21 CFR part 117, subpart G or part 507,
subpart E (21 CFR 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 21 CFR 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.

Contains Nonbinding Recommendations
4
III. 	Discussion
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 compliance
dates (Ref. 1).
As noted in section II, the supply-chain program provisions permit a co-manufacturer to review
and assess documentation of a brand owner’s determination, conduct, or both determination and
conduct, of appropriate supplier verification activities, provided that the co-manufacturer
documents its review and assessment of the brand owner’s applicable documentation. (See 21
CFR 117.415(a)(3) and 507.115(a)(3).) 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 for food manufactured for the brand owner. Specifically, we do not intend to take
enforcement action regarding 21 CFR 117.410(d) and 117.415(a)(3) or 21 CFR 507.110(d) and
507.115(a)(3) in the circumstances described below. Furthermore, we do not intend to take
enforcement action under the FSVP regulation against an importer who is relying on 21 CFR
1.502(c)(3) but whose supply-chain program is subject to enforcement discretion regarding 21
CFR 117.410(d) and 117.415(a)(3) or 21 CFR 507.110(d) and 507.115(a)(3) in the
circumstances described below.
Supplier Approval
FDA does not intend to take enforcement action under the following circumstances: (1) a brand
owner conducts supplier approval activities, (2) the co-manufacturer describes these activities in
its food safety plan, and (3) the co-manufacturer conducts any necessary supplier approval
activities not conducted by the brand owner. For example, FDA does not intend to take
enforcement action when a brand owner (rather than the co-manufacturer) evaluates supplier
performance as part of approving a supplier, the co-manufacturer’s food safety plan states that
the brand owner will consider supplier performance before a supplier is approved, and the co-
manufacturer conducts any other necessary supplier approval activities (e.g., hazard analysis of
the food). The co-manufacturer is always responsible for following written procedures for
receiving raw materials and other ingredients, and documenting use of the procedures (21 CFR
§§ 117.420 and 507.120).
Supplier Verification
FDA does not intend to take enforcement action under the following circumstances: (1) a brand
owner determines and/or conducts supplier verification activities for its co-manufacturer, (2) the

Contains Nonbinding Recommendations
5
co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer
conducts any necessary supplier verification activities not conducted by the brand owner. For
example, FDA does not intend to take enforcement action when an audit is determined to be the
appropriate supplier verification activity but a co-manufacturer does not independently obtain a
supplier audit or review the conclusions of a supplier audit obtained and reviewed by the brand
owner, the co-manufacturer’s food safety plan states that the brand owner will obtain and review
audits of the supplier, and the co-manufacturer conducts any other necessary supplier verification
activities (e.g., sampling and testing of the raw material or other ingredient).
We do not intend to take enforcement action regarding the affected provisions until November 6,
2019.
Co-manufacturers to whom this policy applies still must comply with the importer identification
requirements in 21 CFR 1.509, if they are also FSVP importers. Under 21 CFR 1.509(a), for
each line entry of food product offered for importation into the United States, the importer must
provide its name, electronic mail address, and unique facility identifier recognized as acceptable
by FDA electronically when filing entry with U.S. Customs and Border Protection. FDA has
recognized the Dun & Bradstreet Data Universal Numbering System (DUNS) number as an
acceptable unique facility identifier for the FSVP rule. When a food product under FDA
oversight is offered for entry into the United States, the U.S. Customs and Border Protection
(CBP) Automated Commercial Environment (ACE) system will prompt the filer to transmit an
“FSV” entity role code indicating the entry line is subject to the FSVP regulation and currently
subject to FSVP enforcement. For more information on importer identification, consult
“Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for
the Foreign Supplier Verification Programs Regulation,” available at
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm556661.htm.
IV. References
The following references are on display in the Division of Dockets Management, Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has verified the Web site
addresses, as of the date of this document, but Web sites are subject to change over time.
1. Letter from Grocery Manufacturers Association to Dr. Stephen Ostroff, Acting Commissioner
of Food and Drugs, February 7, 2017.