FSVP Exemptions

Team

Updated May 17, 2017

Not all foods or food manufacturers and growers are subject to FDA’s Food Safety Modernization Act (FSMA) requirements. Some are exempt by statute, others by regulation. During implementation and roll out of FDA’s FSMA regulations, the Agency also identifies compliance enforcement dates to enable industry to prepare for FDA inspections focusing on the new requirements. These compliance enforcement dates are not technically exemptions and many times are dependent upon regulatory exemptions that apply to other parties in the upstream supply chain.

FSVP Statutory and Regulatory Exemptions
The FDA exempts firms that fit the following criteria from some or all of the provisions of FSVP.

Importers of dietary supplements who are subject to and verify compliance with certain specifications under the Current Good Manufacturing Practices (CGMPs) for Dietary Supplements or who can demonstrate that their customer is compliant will not need to fulfill most FSVP requirements.
Some importers of Dietary Supplements are exempt from the hazard analysis, provided they comply with FDA’s Dietary Supplement CGMPs. [CAUTION: Most Dietary Ingredient (bulk substance and raw material) manufacturers are not subject to Dietary Supplement CGMPs at all and are excluded from FSMA exemptions. They are therefore excluded from this FSVP exemption.]

The following foods are not covered by the FSVP regulations.

  • Juice, fish, and fishery products subject to and in compliance with FDA’s applicable Hazard Analysis and Critical Control Point (HACCP) regulations.
  • Alcoholic beverages and certain ingredients used in alcoholic beverages.
  • Food imported for the purpose of research or for personal consumption
  • Food that is imported to be processed and exported
  • Meat, poultry, and egg products regulated by USDA at the time of importation

FSVP Statutory and Regulatory Modified Requirements
There are modified requirements if the hazard is controlled downstream for certain foods from foreign suppliers in countries with a food safety system recognized as comparable or equivalent to the U.S. system.

    *Very small importers or importers of food from certain small suppliers are permitted to establish a modified FSVP.
    *Thermally processed Low-acid canned foods (LACF) packaged in hermetically sealed containers, though this exemption only applies to microbiological hazards.

Limitations of Exemptions

Each of these exemptions and modifications is limited. Many foreign facilities that are already subject to these other food and beverage safety requirements (e.g., HACCP) will still be subject to Hazard Analysis and Risk-based Preventive Controls (HARPC or Preventive Controls) and Standards of Produce Safety. Therefore, U.S. Importers bringing foods from such suppliers will still be subject to FSVP.

Many dietary ingredient manufacturers are not subject to FDA’s Dietary Supplement CGMPs. Therefore, such dietary ingredient manufacturers are subject to HARPC and imported food from such foreign dietary ingredient manufacturers are subject to FSVP. These facilities are not excluded by the Dietary Supplement CGMP-compliance exemption because they are not subject to FDA’s Dietary Supplement CGMP rule at all.

As we have stated previously, the exemptions are largely illusory because FDA’s other food safety programs do not cover all food safety hazards (e.g., LACF) or all elements of food adulteration (e.g., HACCP), both of which are required by HARPC, Standards of Produce Safety and FSVP. If firms fail to appreciate the limitations of these exemptions, they will fail to implement the FSVP requirements, eventually leading to FDA import refusals and import alerts targeting both the Foreign Suppliers and the Importers. Placement onto an FDA Import Alert red list will significantly increase the costs of importing. NOTE: For the immediate future we expect FDA to remain in Educational Mode and not move to Enforcement Mode unless the agency finds something that introduces a significant food safety risk during an FSVP Importer inspection.

Timing of FSVP (Effect of Compliance Enforcement Dates)

May 30, 2017

Beginning May 30, 2017, imported food shipments, from large food facilities subject to the FDA’s Preventive Control Rule (HARPC) or Standards for Produce Safety Rule will fall within FDA’s comprehensive FSVP Rule. Therefore, the FSVP Importer of such food shipments must be prepared on that date to demonstrate compliance with FSVP for each shipment of food and foreign supplier. Further, all food importers will be required beginning May 30, 2017 to provide to Customs and FDA (through the Automated Commercial Environment – ACE) the FSVP Importer Name, Address, and unique identification number (which FDA has determined will be the FSVP Importer’s DUNS#).

There is a way through this process for shipments of food that are from facilities that are exempt or where the implementation dates have not yet passed (e.g., small foreign food suppliers). Shipments of food that are exempt from FSVP (e.g., for personal use, or for transhipment) can be declared to FDA and Customs using an Affirmation of Compliance (AoC) code indicating the shipment contains FSVP-exempt food. Food shipments from foreign suppliers that are exempt from HARPC or Standards of Product Safety (e.g., seafood and juice subject to HACCP) can also be declared using the exempt AoC code. Imported food from small foreign suppliers, which are not yet subject to HARPC or the Standards of Produce Safety (only due to their size) may also be declared to Customs and FDA using an AoC code that indicates the FSVP data is not required at entry. We strongly recommend all food importers obtaining affirmations from foreign suppliers to confirm use of the AoC is justifiable.

Contact us or send your customs broker or freight forwarder to us with any questions.