FSVP for Whom and Why

Inapplicability to certain meat, poultry, and egg products. This subpart does not apply with respect to:

(1) Meat food products that at the time of importation are subject to the requirements of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);

(2) Poultry products that at the time of importation are subject to the requirements of the USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.); and

(3) Egg products that at the time of importation are subject to the requirements of the USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

Importers who establish and verify compliance with certain specifications (concerning dietary supplement components and packaging) required under the separate, pre-existing dietary supplement Current Good Manufacturing Practices (CGMP) regulation will not be required to comply with most of the standard FSVP requirements.

The same would apply to importers whose customer is required to establish such specifications and verify that they are met, except that the importer would have to obtain written assurance that its customer is complying with those requirements.

Importers of other dietary supplements, including finished products, would be required to comply with most of the standard FSVP requirements (except the hazard analysis requirement) but their verification activities would focus on compliance with the dietary supplement CGMP regulations.

Modified FSVP requirements are established for very small importers and importers of food from certain small suppliers. (An example of these modified requirements is that certain importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances from their supplier.)

The definition of very small importer is consistent with the definition of very small business in the preventive controls rules: a sales ceiling of $1 million for human food and $2.5 million for animal food.

Importers of certain small foreign suppliers are subject to modified FSVP requirements. Those small suppliers are:

• Facilities subject to modified requirements under the preventive controls rules because they are qualified facilities
• Farms that are not covered farms under the produce safety rule because they average $25,000 or less in annual produce sales or because they meet requirements for a qualified exemption
• Shell egg producers with fewer than 3,000 laying hens

Each of these types of producers is either exempt from their underlying FDA food safety regulations or subject to modified requirements, mostly, and in some cases entirely, because of the size of these firms.

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.

Additionally, certain categories of imported food are not covered by FSVP. These include:

• Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for those products, and 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.
• Food that is imported for processing and future export
• Low-acid canned foods (LACF), such as canned vegetables – but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards).
• Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation.