Importers of food products intended for introduction into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements.
Imported food products are subject to FDA inspection when offered for import at U.S. ports of entry.
FDA may detain shipments of products offered for import if the shipments are found not to be in compliance with U.S. regulations.
The FSVP rule requires importers to perform risk-based foreign supplier verification activities to verify that:
● The food is produced in a manner that provides the same level of public health protection – hazard analysis and risk-based preventive controls or standards for the safe production and harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs), if applicable
● The food is not adulterated
● The food is not misbranded (food allergen labeling).
For the purposes of FSVP, an importer is the:
▪ U.S. owner or consignee of a food offered for import into the United States.
▪ U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.
Importers are required to develop, maintain and follow an FSVP for each food brought into the United States and the foreign supplier of that food.
If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers.
Similarly, if the importer obtains many different foods from a single supplier, a separate FSVP would be required for each food.
Importers are not required to evaluate the food and supplier or conduct supplier verification activities if they receive adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety in accordance with applicable requirements.
The evaluation of the risk posed by the imported food and the supplier’s performance must be reevaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier’s performance.
Such evaluation would have to consider the following factors:
▪ Formulation of the food.
▪ Condition, function and design of the establishment and equipment of a typical entity that produces the food.
▪ Raw materials and other ingredients.
▪ Transportation practices.
▪ Harvesting, raising, manufacturing, processing and packing procedures
Packaging and labeling activities.
▪ Storage and distribution.
▪ Intended or reasonably foreseeable use.
▪ Sanitation, including employee hygiene.
Risks posed by imported food that are reasonably likely to cause illness or injury include:
● Biological hazards (parasites and disease-causing bacteria).
● Chemical hazards (radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens).
● Physical hazards, such as glass.
Said hazards occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain, such as substituting a less costly ingredient.
There are modified requirements for certain foods from a foreign supplier in a country whose food safety system has been recognized as comparable or determined to be the equivalent of the United States’ system.
The United States and certain countries have entered into Food Safety Systems Recognition Arrangements (SRA).
Moreover, modified FSVP requirements are also established for very small importers and importers of food from certain small suppliers.
Imported foods that are not covered by FSVP:
▪ Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations.
▪ Certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations.
▪ Food for research or evaluation.
▪ Food for personal consumption.
▪ Alcoholic beverages and certain ingredients for use in alcoholic beverages.
▪ Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation.
Ready to import, but unable to comply with multiple regulatory requirements?