UPDATE 01-29-2018 : The next compliance date is March 19, 2018 for most food importers (who purchase food from foreign suppliers with fewer than 500 FTEs) .
FDA’s Foreign Supplier Verification Plan (FSVP) first implementation date was May 30, 2017, which had food importers and their foreign suppliers scrambling to understand what is required and when.[1] Along with that, importers wanted to know when FDA would start enforcing FSVP requirements and what that enforcement might look like.
Shipment Holds Highly Unlikely
The worry was that on May 31, 2017 FDA would begin issuing import refusals against all food shipments with an importer that lacks a perfect FSVP. However, FDA has publicly stated that it does not intend to verify compliance with the FSVP rule in conjunction with an individual shipment. In other words, FDA currently does not intend to hold a shipment while it reviews the importer’s FSVP system. If FDA were to conduct such a review, the worry is that FDA would subject the product to an extended hold and then possibly issue an import refusal if it objects to the importer’s FSVP.
We anticipate that FDA’s initial inspections will be focusing more on whether the importer has an FSVP or not for each food – as compared to a deep audit into the FSVP itself. FDA continues to train its inspection and compliance staff on the regulation, and it will take time for FDAs staff to become familiar with the rule. Furthermore, FDA still has not issued any substantive guidance (even in draft form) about how to comply with the rule. This guidance is legally required under the Food Safety Modernization Act (FSMA), and in theory was supposed to have been published in 2012.
Education Before Enforcement
When FDA introduced similar systems-based regulations in the past (i.e. seafood HACCP and the Preventive Control rules) the approach focused on education and voluntary compliance in the early stages. If FDA observes an issue with the FSVP system, FDA will likely give the importer an opportunity to voluntarily fix it prior to taking an enforcement action, including issuing import refusals.
The FSVP Importer is responsible for establishing a legally acceptable program and implementing it — FDA does not “approve” an importer’s FSVP, nor must the importer file its FSVP with FDA. Rather FDA has indicated that it will inspect an importer’s FSVP under a facility inspection model. Thus, an inspector will arrive at the importer’s office and inspect various aspects of the importer’s FSVP (or the request may come by email). While FDA is reviewing the FSVP system, import shipments will continue to be released/examined as normal (there may be increased FDA examination if the Agency observes something concerning, but the shipments will not simply be refused without notice).
Of course, completely ignoring your obligations as an FSVP Importer or having an egregious violation certainly could trigger a strong enforcement action. Importers cannot afford to delay implementing a FSVP, as enforcement actions can include stopping all future shipments and placing a company on FDA’s import alert list.
Importers First Steps
If you haven’t analyzed the impact of FSVP on your food imports business yet, here are some initial steps you should take.
- Identify your foreign suppliers and the foods you import from them.
- Determine your compliance date(s) and obligations.
- Get to work on the FSVP process. You’ll need to perform a hazard analysis for each imported food, and analyze your suppliers’ compliance histories. Then conduct verification activities such as facility inspections, testing or record review, and put corrective action procedures in place where needed.
- Be prepared to provide documentation with each shipment, including a DUNS number as the Unique Identifier for your facility.
FDAImports.com’s team of regulatory consultants and attorneys helps FSVP Importers and their suppliers with action plans, training, and guidance. FSVP is complex and confusing, but we take companies through the requirements step-by-step. Contact us today with your questions.
[1] See FDAImports.com blogs to learn more about key FSVP issues:
DUNS Numbers to Play Role in FSVP Compliance
FSVP: Requirements for Hazard Analysis, Risk Evaluation, and Supplier Compliance
Who‘s Who in FSVP: Importer, Foreign Supplier
Foreign Supplier Verification Program: Who Needs One?
For even more FSVP information check out our videos below:
- FSVP: Understanding FDA’s Foreign Supplier Verification Plan
- FSVP: What the Regulation Says and Who it Applies to
