The FSVP Importer may or not be the same entity that serves as the “Importer of Record” for purposes of U.S. Customs and Border Protection requirements.
In most cases, the FSVP Importer is the
- U.S. Owner or Consignee of an article of food that is being offered for import into the United States
- U.S. Agent or representative of the foreign owner or consignee at the time of entry
On May 10, 2021, the FDA launched the FSVP Importer Portal for FSVP Records Submission as a means for importers to upload FSVP records electronically to the Agency, after receiving a written request from FDA for records.
When food is offered for entry into the United States, the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system will require the filer to enter at least one additional code as part of the required data elements.
FSVP Importers should use the entity role code “FSV,” indicating the entry is subject to the FSVP regulation. This will then prompt the ACE system to ask for the importer’s name, email address, and unique facility identifier (UFI) or DUNS Number.
Under modified requirements, importers do not have to conduct hazard analyses or evaluate the food and foreign supplier.
For the modified requirements to apply, the importer will need to annually document its “very small importer” status or obtain assurance that its foreign supplier meets the criteria as “small” foreign supplier.
Importers of dietary supplements and dietary supplement components, as well as importers of certain food from foreign suppliers in countries whose food safety systems FDA has officially recognized as comparable or equivalent, can take advantage of the modified requirements.
The written assurance must include either
- A brief description of the preventive controls that the supplier is implementing to control the applicable hazard in the food
- A statement that the supplier is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries
FSVP does not apply to these foods:
- Fish and fishery products, or certain ingredients for use in fish and fishery products
- Juice, or certain ingredients for use in juice products
- Food for research or evaluation
- Certain alcoholic beverages, or certain ingredients for use in alcoholic beverages
- Certain meat, poultry, and egg products regulated by USDA
- Food imported for personal consumption
- Food that is transshipped
- Food that is imported for processing and export
- U.S. food that is exported and returned without further manufacturing/processing in a foreign country
Very Small Importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance.
Remember that, unlike traditional facility inspections, FSVP inspections are based on the review of records submitted electronically, rather than observations of food production or products at a warehouse.
Therefore, we expect you to provide all related documentation, upon request.
Small and Mid-Sized Importers may be less ready to comply with FSVP requirements than their Large Importer and Food Producer counterparts.
Most companies claim that they have their own plan, using some form of industry-recognized processes or methods, such as Hazard Analysis Critical Control Point (HACCP) plans, Global Food Safety Initiative (GFSI) schemes, or other food defense and food safety programs to verify the safety of food being imported into the United States. Secondly, they rely on assertions (import letters, letters of guarantee), certifications (Certificates of Analysis or COAs), and other forms of documentation (supplier hazard or risk documentation) provided directly by the suppliers asserting that the food they are selling is safe. The third most cited verification activity is onsite supplier audits. Importers (large and small), brokers, and food producers periodically visit or engage third-party auditors to conduct audits of foreign facilities to ensure that the supplier maintains safe practices, procedures, and operations on an ongoing basis.
There is a training for importers available through the Food Safety Preventive Controls Alliance (FSPCA) designed to provide the knowledge required to meet the FSVP requirements. The training is also available to others who have an interest in ensuring that FSVP requirements are met, such as brokers, foreign suppliers, and representatives of foreign governments.
Any Challenges to Meeting FSVP Requirements?
Here are the main ones: educating foreign suppliers, combating misinformation, working with documents in different languages, having to overcome language barriers, and working as smaller businesses typically under-resourced and unable to dedicate complete resources to fulfilling the requirements of FSVP.
FSVP Information in Foreign Languages