Reporting requirements for the Food Safety Modernization Act (FSMA) Foreign Supplier Verification Program (FSVP) became mandatory on May 30, 2017. Although the initial struggle to comply with the new program has greatly diminished, there is still room for improvement. The Food and Drug Administration (FDA) completed only a few FSVP audits in the U.S. Federal Fiscal Year (FY) 2017, so importers should expect that FY 2018 will bring with it the promise for a larger number of reviews.
What qualifies a FSVP importer?
Are you preparing Customs documents, but you’re not the actual FSVP importer? Then you’ll want to verify with the importer, preferably in writing, that they are willing to act as the FSVP importer. Not all companies who are defined under the law as the FSVP importer are willing to take on the responsibilities required of this role. If the party nominated is audited by the FDA and can show that they did not agree to act in this capacity, the FDA may be able to take other actions against the CBP Importer of Record.
- An FSVP importer is the U.S. owner or consignee of a food offered for import into the United States.
- If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.
- FSVP Importers can engage the services of a third party to perform certain functions, such as providing a qualified individual, but must still take responsibility for compliance with the FSVP.
How do comparable food safety systems apply to FSVP?
Did you know that some countries have a comparable food safety system as compared to the United States? These countries, including Canada, New Zealand, and Australia, have been recognized by the FDA under the FSMA as having a “comparable food safety system”, and therefore require less stringent import requirements. The FSMA provides special recognition for these countries under the FSVP. While goods from these importers must still comply with safety rules in their own countries, compliance for the FSVP importer in the United States is greatly mitigated. In short, the FSVP importer must perform two functions before importing a food from the foreign supplier:
- The FSVP importer must document that the foreign supplier is in and under the regulatory oversight of a country whose food safety system has been officially recognized by the FDA as comparable or equivalent to the United States. The food must also be within the scope of the official recognition or equivalency determination. The documentation requirements must be completed on an annual basis.
- The FSVP importer must determine and document whether the foreign supplier of the food is in good compliance standing with the food safety authority of the country in which the foreign supplier is located. The FSVP importer must also continue to monitor the foreign supplier’s compliance and promptly review any information obtained.
- If the information indicates that food safety hazards associated with the food are not being significantly minimized or prevented, the FSVP importer must take prompt corrective action. The appropriate corrective action will depend on the circumstances, but could include discontinuing use of the foreign supplier. The FSVP importer must document any corrective actions that they undertake.
What are the compliance dates for small foreign suppliers?
The new FY will also bring with it the end of the popular delayed implementation for “small foreign suppliers”. This “exemption” waived reporting requirements for the FSVP importer when their foreign supplier employed less than 500 (FTE) employees. This modified reporting waiver ends March 19, 2018.
The effective date is March 18, 2019 for importers sourcing from “very small manufacturers” or importers themselves who qualify as a “very small importer”. These importers have average annual (worldwide) sales over the past three years of less than $1 million. These figures include sales of any subsidiaries and affiliates.
What are the requirements for ACE entry documents?
The FSVP importer will be required to supply certain data to their Customs broker, for transmission to the FDA as part of the release data sent to CBP via the ACE system. These data elements include (but are not limited to):
- FSVP Importer Company Name
- FSVP Address
- E-mail Address
- DUNS Number
- FSVP Contact Name
Having an established and implemented FSVP program will aid you in any upcoming FDA inspections that examine your compliance with the FSVP requirements. Inspections will largely be based on the review of records, though inspectors may look for evidence that FSVP procedures are followed between the importer and the supplier of the goods and that the importer is documenting analyses and verification activities.
For further information, please see the Food Safety Preventive Controls Alliance (FSPCA), which has developed training regarding supplier verification for importers subject to FSVP regulation.