FDA issued the final rule for the Foreign Supplier Verification Program (FSVP) last week. This final rule is the first step in implementing the Food Safety Modernization Act’s (FSMA’s) mandate that U.S. importers verify their foreign manufacturers’ compliance with U.S. law. As the industry faces this new requirement, firms must first determine whether it even applies to them – and, if so, under which standard, as several requirements are modified depending on the situation.
Who Needs One:
FDA requires all food (human and animal) importers to develop and implement a FSVP. A food importer is defined as “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry…” 21 C.F.R. 1.500.
It’s important to recognize that the “importer” from an FSVP perspective is possibly different than the “importer of record” from a Customs perspective. Frequently, they will be the same; however, when a shipment has a Customs foreign importer of record, the U.S. consignee will be the “importer” for the purposes of the FSVP regulations.
Who Doesn’t Need One:
While the definition of “importer” is extremely broad, the rule has several exemptions. Those importing the following types of food or type of situations are exempted from the FSVP requirement:
- Food subject to HACCP. Not only are seafood and juice exempted, this exemption applies to the raw material ingredients that are processed according to a seafood or juice HACCP program.
- Food for research and evaluation. To claim this exemption, the importer needs to file an electronic declaration at the Customs that the food will used for research or evaluation and will not be sold or distributed to the public, among other requirements.
- Food for personal use.
- Alcohol subject to TTB jurisdiction.
- Food not intended for the U.S. market. This includes food brought into the United States to simply transship through the country, but it also includes food imported for further processing and exporting.
- U.S. food returned. This only applies if the food was not further processed when overseas.
- USDA (FSIS) regulated products.
Needs One with Modified Requirements:
Under the following circumstances, the importer must still have an FSVP, but must only satisfy modified requirements:
- Importing food subject to supply-chain control under a preventive control plan.
- Importing food subject to dietary supplement cGMPs.
- Very small importer. For human food, a very small importer (including any subsidiaries and affiliates) who “average[s] less than $1 million per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale (e.g., importer for a fee.)” is exempted. For animal food, the amount is 2.5 million a year. 21 C.F.R. 1.500.
- Small foreign supplier that is a qualified facility under the preventive control rule.
- Farm growing produce not subject to the produce safety rule.
- Shell egg producers with fewer than 3,000 laying hens.
- Officially recognized countries. Thus far FDA has officially recognized New Zealand, Australia and Canada.
Once an importer takes this critical first step – determining whether the requirements of FSVP apply to them – they can begin developing an appropriate FSVP for each food imported.
For Part 2 of our FSVP series please read here.
For more information regarding FSVP please watch the videos below.
