Unless exempt, all importers of human and animal food must develop, maintain, and follow an FSVP for each food and foreign supplier.
FSVP’s documentation must now be submitted electronically, as the FDA shifts to conducting this inspection remotely during the COVID-19 public health emergency.
Importers are required to establish and follow written procedures to ensure that they import foods only from foreign suppliers they approved based on an evaluation of the risk posed by the imported food and the supplier’s performance, or from suppliers whose foods are subjected to adequate verification activities before being imported.
Identify known or reasonably foreseeable hazards in each food:
> Biological, chemical, and physical hazards
> Foreseeable hazards that may be present in a food because
■ hazard occurs naturally
■ hazard may be unintentionally introduced
■ hazard may be intentionally introduced for purposes of economic gain.
Evaluate identified hazards, including pathogens, to assess probability that hazard will occur in the absence of controls and the severity of the illness or injury, if the hazard were to occur.
Relevant factors to consider:
■ formulation, condition, function, and design of the establishment and equipment of a typical entity that manufactures/processes, grows, harvests, or raises this type of 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.
Reevaluate if new information or concerns relating to foreign supplier or at the end of any 3-year period.
Take actions: discontinue use of foreign supplier, change verification activities, based on reevaluation if results of verification activity do not provide adequate assurance that hazards requiring a control in the food were significantly minimized or prevented.
Documentation: a qualified individual conducted the hazard analysis. Must be performed by entity other than foreign supplier.
Before food is imported or offered for import, if there is no U.S. owner or consignee, the U.S. Agent or representative becomes the importer.
ITB HOLDINGS LLC assists companies in the United States, Canada, Mexico, Brazil, Australia, India, China, Japan, South Korea, Russia, Portugal, Spain, Italy, France, Belgium, Netherlands, Switzerland, Germany, Sweden, United Kingdom, and Ireland that are exporting or importing food products.