Foreign Supplier Verification Programs guidance, fact sheet and documentation - [Single Window #2201]

In the last weeks, the U.S. Food and Drug Administration (FDA) released multiple documents regarding the Food Safety Modernization Act (FSMA) including the Foreign Supplier Verification Program (FSVP).

1. On August 7, 2017, the FDA released guidance on exemptions under FSMA for products covered by existing regulations for the control of biological standards or HACCP  - Low-Acid Canned Foods and FSMA, Juice HACCP and FSMA, Seafood HACCP and FSMA. 
2. On August 10, 2017, the FDA released A Conversation with Jenny Murphy on the preventive controls for animal food rule under FSMA. Please note that starting September 18, 2017, larger animal food facilities located in the U.S. or who are manufacturing animal food for export to the U.S., will have to comply with the preventive controls requirements, and that small animal food facilities will be required to meet Current Good Manufacturing Practices.
3. On August 14, 2017, the FDA issued guidance to clarify that a waiver to the Sanitary Transportation of Human and Animal Food final rule covers retail food establishments that sell food for humans, including those that sell both human and animal food, but does not apply to establishments that only sell food for animals. As instructed in April 2017, waivers are available for certain milk shipments, food establishment and businesses transporting molluscan shellfish.
4. On August 22, 2017, the FDA launched a Food Safety Plan Builder to help businesses comply with FSMA requirements. The Food Safety Plan Builder (FSPB) is a free software application that businesses can download to guide them, step-by-step, through the creation of a food safety plan, as required by FSMA.
5. In a Federal Register final rule released on August 24, 2017, the FDA provided extensions and clarifications of compliance dates for certain provisions of four implementing rules in the FSMA, including the FSVP. We encourage Canadian stakeholders to review this notice as it could provide more time for your operations to comply with the FSVP and other requirements.
6. On August 30, 2017, the FDA released the sixth chapter of the draft guidance for the PC-human food rule. The draft guidance is intended to help food facilities comply with specific requirements of the preventive controls for human food rule, mandated by the FSMA, such as developing a written food safety plan, establishing preventive controls, and taking corrective actions. Chapter 6 focuses on providing information on how to establish and implement a heat treatment as a process control for bacterial pathogens.  
7. On September 5, 2017, the FDA released a Compliance Guide for Small Businesses under the FSMA Produce Safety Rule. The document provides information that can help small and very small businesses understand how the requirements of the produce safety rule apply to them.

From a Canadian point of view, although the majority of documents target U.S. companies who have to comply with the FSMA regulations, Canadian manufacturers exporting to the U.S. are also impacted.  Some particular areas to note:

• Canadian companies manufacturing or processing low-acid canned foods, juice or seafood for export to the U.S. should review the guidance in 1) as it clarifies the requirements for foreign suppliers under the FSVP program.
• As highlighted in the link in point 2), the FDA stated that "because the FDA is not yet beginning inspections of animal food facilities to ensure compliance with preventive control requirements, the agency will also not begin FSVP inspections for animal food importers until the fall of 2018. This way the start of the FSVP inspections for these importers will be aligned with the start of preventive controls inspections for animal food".
• Through the final rule released on August 25, 2017, in 5), the FDA extended the compliance dates for the importation of food contact substances under the FSVP rule. As a result, the earliest that an importer will be required to comply with the FSVP for the importation of food contact substances is May 28, 2019.

Please let us know if you have any questions.
Market Access Secretariat 
Agriculture and Agri-Food Canada 
1341 Baseline Road, T5-3-346
Ottawa, Ontario K1A 0C5
E-mail Address: [email protected]