Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry; Availability, 51345-51347 [2017-24098]

Download as PDF Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations airspace action makes minor updates to certain boundary coordinates of restricted areas R–2516, R–2517, R– 2534A and R–2534B; Vandenberg AFB, CA, to match the digital shoreline data received from the NOAA Administration. This ensures that the affected boundaries continue to match the NOAA-defined position of the U.S. shoreline. It does not alter the location, altitudes, or activities conducted within the airspace; therefore, it is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment. List of Subjects in 14 CFR Part 73 Airspace, Prohibited areas, Restricted areas. Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73, as follows: Boundaries. Beginning at lat. 34°38′35″ N., long. 120°31′24″ W.; to lat. 34°35′45″ N., long. 120°28′14″ W.; to lat. 34°36′20″ N., long. 120°27′24″ W.; to lat. 34°30′00″ N., long. 120°15′34″ W.; to lat. 34°25′00″ N., long. 120°15′34″ W.; thence 3 NM from and parallel to the shoreline to lat. 34°24′39″ N., long. 120°19′13″ W.; to the point of beginning. R–2534B Vandenberg AFB, CA [Amended] By removing the current boundaries and inserting the following: Boundaries. Beginning at lat. 34°38′35″ N., long. 120°31′24″ W.; to lat. 34°24′39″ N., long. 120°19′13″ W.; to lat. 34°25′00″ N., long. 120°27′04″ W.; to lat. 34°35′00″ N., long. 120°32′04″ W.; to the point of beginning. * * * * * Issued in Washington, DC, on October 31, 2017. Rodger A. Dean, Jr., Manager, Airspace Policy Group. [FR Doc. 2017–24103 Filed 11–3–17; 8:45 am] BILLING CODE 4910–13–P PART 73—SPECIAL USE AIRSPACE DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. The authority citation for part 73 continues to read as follows: ■ Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389. Food and Drug Administration § 73.25 [Docket No. FDA–2017–D–5996] [Amended] 2. Section 73.25 is amended as follows: * * * * * ■ Pmangrum on DSK3GDR082PROD with RULES R–2516 Vandenberg AFB, CA [Amended] By removing the current boundaries and inserting the following: Boundaries. Beginning at lat. 35°00′06″ N., long. 120°42′12″ W.; to lat. 34°54′00″ N., long. 120°33′04″ W.; to lat. 34°50′00″ N., long. 120°32′04″ W.; to lat. 34°46′00″ N., long. 120°27′04″ W.; to lat. 34°42′00″ N., long. 120°30′04″ W.; to lat. 34°38′35″ N., long. 120°31′24″ W.; to lat. 34°42′00″ N., long. 120°34′34″ W.; to lat. 34°42′00″ N., long. 120°40′01″ W.; thence 3 NM from and parallel to the shoreline to the point of beginning. R–2517 Vandenberg AFB, CA [Amended] By removing the current boundaries and inserting the following: Boundaries. Beginning at lat. 34°42′00″ N., long. 120°40′01″ W.; to lat. 34°42′00″ N., long. 120°34′34″ W.; to lat. 34°38′35″ N., long. 120°31′24″ W.; to lat. 34°35′00″ N., long. 120°32′04″ W.; to lat. 34°25′00″ N., long. 120°27′04″ W.; to lat. 34°24′04″ N., long. 120°29′51″ W.; thence 3 NM from and parallel to the shoreline to the point of beginning. * * * * * R–2534A Vandenberg AFB, CA [Amended] By removing the current boundaries and inserting the following: VerDate Sep<11>2014 14:44 Nov 03, 2017 Jkt 244001 21 CFR Parts 1, 117, and 507 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. The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ‘‘SupplyChain Program Requirements and CoManufacturer 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 RiskBased 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 SUMMARY: PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 51345 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- E:\FR\FM\06NOR1.SGM 06NOR1 Pmangrum on DSK3GDR082PROD with RULES 51346 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 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/201523389.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 selfaddressed adhesive labels to assist that office in processing your request. See VerDate Sep<11>2014 14:44 Nov 03, 2017 Jkt 244001 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 (§ 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 ‘‘comanufacturing’’ 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 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 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 supplychain 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. Comanufacturers 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 comanufacturer 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 E:\FR\FM\06NOR1.SGM 06NOR1 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 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 (§§ 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. 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. Pmangrum on DSK3GDR082PROD with RULES III. Electronic Access Persons with access to the internet may obtain the document at https:// www.fda.gov/Food/Guidance Regulation/GuidanceDocuments RegulatoryInformation/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 VerDate Sep<11>2014 14:44 Nov 03, 2017 Jkt 244001 51347 find the most current version of the guidance. Folder on the line associated with this rule. IV. Reference FOR FURTHER INFORMATION CONTACT: 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. SUPPLEMENTARY INFORMATION: 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 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2017–1011] RIN 1625–AA00 Safety Zone, Delaware River; Pipeline Removal Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: The Coast Guard is establishing temporary safety zones in the Mifflin Range on the Delaware River to facilitate pipeline removal in preparation for the deepening of the Delaware River. The safety zones will be established for the waters in the vicinity of the dredge, dredge equipment, dive operations, and pipe removal operations. This regulation is necessary to provide for the safety of life on navigable waters of the Delaware River in the vicinity of pipeline removal operations and to protect mariners from the hazards associated with dredging and pipeline removal operations. Entry of vessels or persons into these zones is prohibited unless specifically authorized by the Captain of the Port Delaware Bay. DATES: This rule is effective from November 6, 2017, through December 4, 2017. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2017– 1011 in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket SUMMARY: PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 If you have questions on this rule, call or email Petty Officer Edmund Ofalt, Waterways Management Branch, U.S. Coast Guard Sector Delaware Bay; telephone (215) 271–4814, email Edmund.J.Ofalt@uscg.mil. I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule due to the short time period between when Sector Delaware Bay received complete details of this project, October 20, 2017, and the date when these safety zones needed to go into effect by. It is impracticable and contrary to the public interest to publish an NPRM to provide a notice and opportunity for comment period because the safety zones must be established by November 6, 2017 to ensure safety of life on navigable waters in the vicinity of dredging operations, underwater cutting operations, and pipeline removal operations and to protect mariners from hazards associated with the same. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to mitigate the hazards presented to safety of life on the Delaware River by the presence of dredge equipment, dredging operations, dive operations, and pipeline removal operations. E:\FR\FM\06NOR1.SGM 06NOR1

Agencies

[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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.