Source: https://www.federalregister.gov/documents/2017/11/06/2017-24098/supply-chain-program-requirements-and-co-manufacturer-supplier-approval-and-verification-for-human
Timestamp: 2018-05-25 09:21:53
Document Index: 715158927

Matched Legal Cases: ['§\u200910', '§\u200910', 'art 117', 'art 117', 'art 507', 'art 507', 'art 117', 'art 507', 'arts 117', '§\u20091', 'art 117', 'art 507', '§\u20091', 'arts 117', '§\u2009117', '§\u2009117', '§\u2009507', '§\u20091', '§\u2009117', '§\u2009507', 'art 117', 'art 507']

Federal Register :: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry; Availability
Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry; Availability
A Rule by the Food and Drug Administration on 11/06/2017
82 FR 51345
51345-51347 (3 pages)
https://www.federalregister.gov/d/2017-24098 https://www.federalregister.gov/d/2017-24098
Instructions: All submissions received must include the Docket No. FDA-2017-D-5996 for “Supply-Chain Program Requirements and Co-Start Printed Page 51346Manufacturer 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.
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.
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 (§ 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 (§ 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 § 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 (§ 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 §§ 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 Start Printed Page 51347compliance 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 (§§ 117.410(d) and 117.415(a)(3) or §§ 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 § 1.502(c)(3) but whose supply-chain program is subject to enforcement discretion regarding §§ 117.410(d) and 117.415(a)(3) or §§ 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.
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.
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.
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.
[FR Doc. 2017-24098 Filed 11-3-17; 8:45 am]