To import human food products into the US, it is mandatory to appoint an FSVP agent
Based on the Foreign Supplier Verification Program (FSVP), a foreign manufacturer or distributor of human food products who intends to freight its merchandise to tradeshows or store chains in the US, or market the products through Amazon or its own branch/division in America, must primarily engage and formally appoint a US resident consultant specializing in the matter of FSVP regulation.
The FSVP dispositions are aimed to ensure that all the human food products to be imported and marketed into the US are subjected to and comply with the regulatory rules applicable to similar American products. Therefore, the FSVP agent, once being appointed by the foreign manufacturer/distributor, has the assignment and the legal responsibility to make sure – in the name and on behalf of the firm – that each and all the products to be imported and marketed in the US comply with the food safety rules administered by the Food and Drugs Administration (FDA).
To carry out its assignment, the FSVP agent will be assisted by a trusted professional qualified for food-safety preventive controls (PCQI) in drafting the FSVP Plan, which is the administrative instrument to certify the foreign supplier’s status of compliance with the FSVP regulation.
In summary, the FSVP agent is engaged by the foreign supplier to ensure that each and all the human food products to be imported by the latter into the US satisfy the requirement of the US regulatory rules and are not adulterated or labeled in a way inconsistent with the relevant US regulations in the matter of allergenic labeling
Procedures that the FSVP agent carries out to prove the Status of Compliance of the foreign supplier and its products with the FSVP – FSMA regulation
The FSVP agent carries out the following procedures:
- Determining the US rules applicable to the foreign supplier and its products for all concerns the manufacturing process, single ingredients, labeling, and characteristics of the finished products to be imported into America.
- Drafting the risk analysis based on the factors of risk associated with the finished products, in biological, chemical, physical, and radiological terms, along with the risk of adulteration for undue profit.
- Determining the specific verification practices required to the foreign supplier to minimize or prevent the possible dangers outlined by the risk analysis and ascertaining that such possible hazards have been minimized or prevented. In addition, the FSVP agent is statutorily required to set the monitoring frequency of the aforesaid verification practices.
- Gathering from the foreign supplier the verification activity reports on the food safety practices implemented in its manufacturing facility, including product labeling checks, inspection reports, Hazard Analysis Risk Preventive Control (HARPC) or Hazard Analysis Critical Control (HACCP), Food Defense, Food Safety System, Recall Plan, along with all the respective third-party reports. The required actions may vary in number and kind depending on the supplier background and company size.
- Reviewing and evaluating all the documents gathered from the foreign supplier, labels included, to draft the FSVP Plan, which is the instrument necessary to approve the foreign supplier and its human food products to be imported into the US. Specifically, the aforesaid revision and evaluation procedure serves the purpose of ascertaining that the foreign manufacturer, in each and all the steps of the manufacturing processes, has diligently applied the risk-analysis preventive controls following the principles of the HARPC system, as prescribed in the US pursuant to the FSMA statutes, and NOT theHACCP’s as applied in Europe. It must be also ascertained that the current good manufacturing practices (CGMPs) and management control procedures have been diligently implemented pursuant to the FSMA rules in the matter of preventive control for human food (PCHF).
Designating the professional roles and respective assignments of the individuals managing the merchandise import, storage, distribution, and the formal communications between the firm and the US federal food and drugs agency (FDA), which may be particularly intense in the case of Product Recalls, with the consequential need for corrective actions, if possible. Such corrective actions may include the Relabeling, Sanitation, Fumigation, or Destruction of the human food products imported into the US.
Procedures and practices required to the foreign supplier and American FSVP Importer pursuant to the FSMA dispositions
The regulation Preventive Control for Human Food (PCHF) constitutes one of the FSMA dispositions and applies with no distinction to all human food manufacturers and distributors, whether American or foreign. The aforesaid regulation prescribes and defines the role of a qualified individual for preventive controls (PCQI), who can be either an employee of the firm or an independent third-party consultant hired to carry out these procedures.
In summary, the PCQI is an employee/official of the firm, or a third-party consultant engaged by the foreign supplier to draft the food safety control plan HARPC. This is an instrument through which the FDA assesses the compliance of the foreign supplier and its products with the US standards and rules, and consequently authorizes the import operations, followed by the delivery and storage of the merchandise at the facility of the supplier’s American client.
Within the meaning of the FSVP plan, the supplier’s American client acts as an FSVP Importer, and in such a vest, must carry out all the control activities assigned by the plan to the type of its company and the category of the products to be import into the US. The HARPC filing is an FDA mandatory requirement applying to the manufacturing and distribution firms, either American or foreign, which store the merchandise in their own storage spaces or in logistic or warehousing rented spaces.
The HARPC plan contains the following documents:
- Risk Analysis aimed to sever those risk that needs preventive control. This checking procedure must be drafted into a form even if none of such risks have been identified.
- Report on food safety preventive controls carried out at the facility with the purpose of minimizing or preventing any potential hazards previously identified by the Risk Analysis.
The Food Safety Plan includes the following check procedures:
- Process controls
- Food allergen controls
- Sanitation controls
- Supply-chain controls
- Recall plan
- Other checks and monitoring procedures to assess the implementation of the preventive controls, corrective actions, and verification procedures
- Food Defense
- Food Safety System
Food Safety Modernization Act (FSMA) regulations
With the new Food Safety Modernization Act (FSMA) regulations, in effect since 2017, the Food and Drug Administration (FDA) has established a stricter and more articulated set of requirements for foreign exporters. As a matter of fact, the latter framework legislation prescribes that the foreign exporter’s shipments to the US must be addressed to and received by a company incorporated in America under the US Commercial Law, in order to obtain customs clearance, public/private storing permit, and green light to distribute, sell (even through web portals like Amazon and similar), and/or expose merchandise on trade fairs in America. Specifically, a relevant FSMA section defines the aforesaid commercial entity as a qualifying “US importer”. It is important to note that nothing on the same legislation prevents the foreign exporter from establishing in America and incorporating under the US Commercial Law its own division or subsidiary/affiliate company for export-import purposes.
In summary, the foreign exporter needs to establish its own commercial entity in America. Once its subsidiary US company qualifies as a “US importer” to the extent of the FSMA regulations, it is officially allowed to distribute, sell, or expose its products on the American market. However, the commercial license comes with the legal duty and responsibilities of certification: The US importer is bound to provide the FDA with documental evidence of compliance with the FSMA preventive risk control programs and other procedures and rules for all the merchandise imported. The same statute moreover specifies that the compliance certification must be executed by a third-party consultant or consulting firm qualifying as an “FSVP agent for US importers” pursuant to the FSMA dispositions of law.