The Foreign Supplier Verification Program

What is the Foreign Supplier Verification Program?

As the name suggests, US importers now have the legal and financial responsibility to approve and verify foreign suppliers, ensuring that the products they import and distribute in the US fully comply with the food safety standards and methods mandated by the Food Safety Modernization act of 2011. This requires three major new procedures:

  1. hiring or engaging a qualified individual with knowledge of Hazard Analysis and Risk-Based Preventive Control (HARPC) methods.
  2. creating a foreign supplier verification program (see below)
  3. providing the FSVP importer “unique facility identifier” (UFI) each time when filing an entry with the Customs and Border Protection (CBP)

Those US importers who are not able to show complete FSVP records upon request by the FDA within 24 hours will or may face fines. Moreover, many larger retailers demand to see proof that importers have and maintain FSVP records.

What Investments are Necessary to Create and Maintain a FSVP?

Importers and Foreign Suppliers are likely to be approached by many consultants and law firms trying to make a quick buck by stirring fear and alarm about the consequences of non-compliance with FSMA and FSVP. No panic, keep calm. The FDA does not have the resources to check all importers at once and is not interested in shutting businesses down. All importers can create and maintain a FSVP under $2,000 and a little dedicated time. They can hire PCQI consultants (Preventive Controls Qualified Individual) or any employee or owner can attend online or in-class training seminars to become qualified. Training is offered at the Food Safety Preventive Control Alliance (FSPCA)

10 Steps to Create a FSVP

  1. Appoint, hire or train a “preventive control qualified individual” who is familiar with matters food safety, hazard analysis, risk assessment and preventive control
  2. Conduct and document a hazard analysis based on the risk profile of your foreign suppliers’ food and beverage products
  3. Document your supplier’s preventive controls of the hazards you identified in the analysis
  4. Document how your supplier and you monitor the implementation of preventive controls in and outside the production facility
  5. Document how your suppliers adjust their controls over time and keeps records of all food safety related activities
  6. Create a recall plan for all food products you’re importing.
  7. If these activities and the resulting food safety plan are part of an audit under the Global Food Safety Initiative (GFSI) scheme, such as IFS, BRC, SQF or SSC 222000, make sure you get a copy of the audit summary and understand, how that audit covers the FSVP requirements.
  8. At least once every three years, visit the factory and become familiar with the systems and checks and balances your supplier have in place to control the safety of the food they produce.
  9. Keep records of all your FSVP activities in an easy to find folder or in computer files. These records have to be made available to the FDA upon request.
  10. Continually inform your employees and your suppliers of your FSVP related activities

What FSVP formats are required?

The FDA prescribes no specific format and it’s up to the importer to establish the most effective FSVP that fits his/her business needs. Of course, it is advisable to keep records in one place, ideally in electronic files and retrievable by any qualified individual in the company. It is also advisable to have a summary of the FSVP ready for retailers upon request.

What are the differences between FSVP Importers, Importers of Record, FDA US Agents and US Import Agents?

The Importer of Record and FSVP Importer are usually the same entity with direct financial interest in the imported food, i.e. those who are the new owner /consignee/purchaser of an import shipment. However, these can also be separate entities. For example, a retailer can be the Importer of Record, while another firm acts as the FSVP importer who creates maintains the FSVP for a given food item and the respective supplier. If no FSVP Importer has been designated by the exporter or customs broker at the point of entry in the US, the FDA will look for a designated US Import agent. This can be any qualified entity (consultant, customs broker, individual) who consented in writing to act as the FSVP Import Agent, without necessarily taking ownership of the food shipment. The FDA US Agent is a US resident who acts as liaison to the FDA in accordance with the Bioterrorism Law of 2001. The Bioterrorism FDA US Agent is not automatically the FSVP US Agent.

What Codes are required to identify FSVP importers and related food products?

FSVP importers are well advised to obtain a Universal Facility Identifier (UFI) Number, at no charge, from Dun & Bradstreet: the so-called DUNS number. When you export a food or beverage products that falls under the FSVP categories is exported, you need to file one of the following Affirmation of Compliance Codes in the CBP / ACE system:

  • FSV – for food products under FDA oversight subject to FSVP
  • FSX – for food exempt from FSVP or not yet subject to FSVP
  • RNE – for food subject to research and evaluation, i.e. samples, not to be sold

Additionally, you need to file the FSVP Importer’s Universal Facility Identifier (UFI), i.e. DUNS Number. If the DUNS Number is not known, the export or import broker can file the Code “UNK” (unkown) for a limited time.

Do Food Audit Standards under the Global Food Safety Initiative (GFSI) cover all FSVP requirements?

The four main GFSI food audit schemes – IFS, BRC, SQF and FSSC 22000 – cover “most all” of the US FSMA, FSVP and Preventive Control requirements. This is the conclusion of a Comparative Analysis between the IFS Standard and FSMA. US Importers are well advised to get a summary report of their suppliers’ most recent GFSI audit as well as the corresponding certificate for the records. In addition, US importers should check other mandatory measures, such as the prevention of intentional adulteration, audits of the external environment etc..

Minimum FSVP documentation you should have on hand for all suppliers

At the very minimum, all importers should maintain an updated file containing the following information about each supplier:

  1. Supplier Contact Name, Title, Email Address, Phone number
  2. Does this company have over 500 employees? Yes No
  3. Factory Name Factory Address Factory Contact Person Contact Person Title Contact Email Address Contact Telephone, Factory Business License Number(s), if available
  4. Food and Drug Administration (FDA) Registration Number(s)
  5. How long has this facility shipped food for human consumption to the US?
  6. Has this facility previously produced any food product recalled by the US Food and Drug Administration (FDA)?
  7. If yes, what type of food was recalled and when?
  8. Has this facility ever been issued a warning letter of cited by local health inspection authorities or the US FDA?
  9. If yes, what was the violation and when was the warning letter issued?
  10. Has this facility been listed on a US FDA Import Alert?
  11. If yes, what was the import alert number?
  12. GFSI certified audit
  13. Which certification body performed the audit on the facility?
  14. What is the GFSI certified audit score?
  15. When is the audit expiration date?

Which products do not require a FSVP ?

Foreign suppliers do not have to identify a FSVP importer when filing a CBP entry or US importers do not have to create and maintain a FSVP for the following food and beverage products:

  • juice and seafood, as long as their suppliers comply with the respective HAACP procedures
  • small quantities of foods and beverages used for research and evaluation, are not intended for retail sales or distributed to the public
  • small quantities for personal consumption
  • low acid canned foods (importers do not have to identify risks of  microbiological hazards, as they are covered by the LACF permit)
  • certain alcoholic beverages
  • trans-shipped foods and beverages
  • meat, poultry and egg products regulated by the USDA

Please note: In 2017, first time exporters do not need a FSVP importer for sending samples to trade shows. After May 30, 2017, use the Acronym UNK as Code for the importer.

Please contact CMA Global Partners , if you have any further questions, are in need of an external FSVP Importer, PCQI or US FDA Agent.