A very small importer is one whose annual average in food sales, and the U.S. market value of food imported, processed, packed, or held without sale, during the previous three-year period is less than U.S. $1 million in human food or less than U.S. $2.5 million in animal food. The very small importer, small foreign supplier, importers of dietary supplements/components, and importers of certain foods from countries with food safety systems officially recognized by the U.S. FDA as equivalent to that of the U.S. are under modified FSVP requirements. These clauses exclude them from having to conduct hazard analyses of the imported food, evaluate the risk of the food, evaluate the foreign supplier’s performance, implement a foreign supplier approval program, or meet certain recordkeeping requirements. There are other requirements of very small importers and their foreign suppliers that cannot be discussed adequately in this column.
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There are also foods exempt from FSVP requirements. Exempted foods include those regulated under the FDA seafood and juice HACCP (Hazard Analysis and Critical Control Point) rules and raw materials and ingredients used for those foods; meat, poultry, or egg products under the USDA regulation; certain alcoholic beverages and raw materials and ingredients for those beverages; those intended for personal or research use and not for sale or distribution in the U.S.; those manufactured or processed, raised, or grown in the U.S. then exported but not subjected to further manufacturing or processing and returned to the U.S.; foods transshipped through the U.S. but not for sale or distribution in the U.S. then exported; foods imported for processing in the U.S. but not for sale or distribution in the U.S. then exported; and low-acid canned foods and raw materials and ingredients for such foods but only for microbiological hazards.
Implementation of the FSVP requirements, however, is still proving to be difficult even for importers eligible for modified requirements. Below are some of the concerns shared with me during my interviews with processors and customs brokers.
Varying FSVP Enforcement Dates
According to some small food processors, they were advised by U.S. FDA that they will probably not see FSVP enforcement for another two years, i.e., by 2020. Other food processors are stating, however, that they are currently seeing enforcement. The FDA may enter any food facility under its jurisdiction at any time of food manufacture, leaving the food processor uncertain when to expect the FDA investigator—leading to increased anxiety levels brought by the unknown.
It is recommended the FDA conduct updates for the industry clarifying FSVP compliance and enforcement dates.
Obtaining a Foreign Supplier’s Food Safety Plan
Having a working food safety plan may be routine practice in most regions in the U.S., but is still considered novel in other areas including overseas. Some processors have encountered foreign suppliers who prefer not to share their food safety plans because those are considered “proprietary.” There is a misunderstanding about the purpose of a food safety plan. It is not understood or accepted that asking for a food safety plan from suppliers and customers is a standard procedure. The food safety plan demonstrates that the processor has evaluated the risks associated with a food item or ingredient, and if the severity of the risks significantly impacts the safety of the food, at least one preventive control must be identified. The food safety plan also details what corrective actions should be taken when deviations occur, including steps to prevent their recurrence. These actions are verified by various means including records review with management sign-off. These records must be kept as evidence of what the food processor declared as critical in protecting the safety of its food.