Service(s) related to this article: Consulting – Food Safety Modernization Act (FSMA) support in meeting requirements, Audits – Assessing readniness for the Food Safety Modernization Act, Global Certifications

The Foreign Supplier Verification Program (FSVP) for importers of food for human and animal consumption is one of the rules under the Food Safety Modernization Act (FSMA) that was finalized in 2015. The FSVP requires importers to verify that food imported into the United States has been produced to meet applicable U.S. food safety standards. Although the compliance dates seem far off, the first compliance date was May 30, 2017. Therefore, importers of human food whose large suppliers require compliance to preventive control of human food must comply with the FDA-FSMA FSVP rules. Although small businesses are not expected to comply until 2018 or even 2020 in some cases, the reality is that foreign supplier verification for food safety has begun. On October 23^rd, the FDA released new compliance dates for the following categories of importers:

Human Food

• Small business foreign suppliers that are required to comply with PCHF – March 19, 2018
• Importers of human food, Grade “A” milk and milk products whose foreign supplier is subject to PMO requirements – March 18, 2019
• Importers of human food whose foreign supplier is a qualified facility (including very small businesses) – March 18, 2019

Animal Food

• Large business foreign suppliers are subject to the PC requirements in PCAF, but not the cGMP requirements – March 19, 2018
• Small business foreign suppliers are subject to PCAF cGMP requirements. – March 19, 2018
• Small business foreign suppliers are subject to the PC requirements in PCAF, but not the cGMP requirements – March 18, 2019
• Foreign supplier is a qualified facility (including very small businesses) subject to PCAF cGMP requirements – March 18, 2019
• Foreign supplier is a qualified facility (including very small businesses) subject to PCAF PC, but not cGMP requirements – March 17, 2020

Produce Safety Rules

• Small business foreign supplier is required to comply with sprout requirements – July 26, 2018
• Small business foreign supplier is a farm producing sprouts and eligible for a qualified exemption – July 26, 2018
• Large foreign suppliers – July 26, 2018
• Very small business foreign supplier is a farm producing sprouts and eligible for a qualified exemption – July 29, 2019
• Small business foreign supplier is subject to produce rule – July 29, 2019
• Importer whose small business foreign supplier is subject to produce safety rule and eligible for a qualified exemption – July 29, 2019
• Very small business foreign supplier is required to comply with sprout requirements – July 29, 2019
• Very small business foreign supplier is subject to produce safety rule and eligible for a qualified exemption – July 29, 2019
• Very small business foreign supplier is subject to the produce safety rule – July 27, 2020

Regardless of when your compliance date is, foreign suppliers must comply to FDA-FSMA rules eventually. At dicentra, our experts in supplier verification, both domestic and foreign, can validate your Foreign Supplier Verification Program as well as audit the foreign supplier facilities for compliance to the FDA-FSMA food safety requirements. In addition, dicentra’s Global Certifications Team is currently in the process of completing an application to become an accredited third-party certification body in the ANSI FDA-FSMA FSVP Pilot program under the FDA-FSMA rules for food safety audits.

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries.

PC: Preventive Controls PCHF: Preventive Controls Human Foods

PCAF: Preventive controls Animal Foods

cGMP: Current Good Manufacturing Practice