For Whom and Why?
The FSVP regulations apply to all FDA-regulated foods imported or offered for import into the United States, with a few partial and somewhat minor exemptions. “Food” includes ingredients in food and beverages, food additives, and color additives used during processing, dietary supplements, and packaging, as well as other substances in contact with food. However, there is a two-year extension for FSVP compliance concerning food contact substances. Foods regulated by the USDA are not subject to FSVP regulations.
Exemption
Inapplicability to certain meat, poultry, and egg products. This subpart does not apply to:
- Meat-based 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 USC 601 et seq.);
- Poultry products that, at the time of importation, are subject to USDA requirements under the Poultry Products Inspection Act (21 USC 451 et seq.);
- Egg products that, at the time of importation, are subject to USDA requirements under the Egg Products Inspection Act (21 USC 1031 et seq.).
Importers who establish and verify compliance with certain specifications (concerning components and packaging of dietary supplements) required under the separate pre-existing Dietary Supplement Current Good Manufacturing Practice (CGMP) regulations will not be required to comply with most standard FSVP requirements.
The same applies to importers whose customer is responsible for establishing these specifications and verifying their compliance, except that the importer must obtain written assurance that their customer complies with these requirements.
Importers of other dietary supplements, including finished products, would be required to comply with most of the standard FSVP requirements (except for the hazard analysis requirement), but their verification activities would focus on compliance with CGMP regulations for dietary supplements.
Modified Requirements
FSVP requirements are modified for very small importers and importers of food from certain small suppliers. (For example, some importers would not be required to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances from their supplier.)
The definition of a very small importer aligns with the definition of a very small business under the preventive control 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. These small suppliers include:
- Facilities subject to modified requirements under the preventive control rules because they are qualified facilities;
- Farms not covered by the Produce Safety Rule because they average $25,000 or less in annual produce sales, or because they meet the 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, mainly due to the size of their businesses.
Other Exemptions
Certain foods from foreign suppliers in a country whose food safety system has been recognized as comparable or equivalent to the U.S. system are subject to modified requirements.
Additionally, some categories of imported foods are not covered by FSVP. These include:
- Juice, fish, and fishery products subject to and compliant with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for these products, as well as certain ingredients used in juice and fish and fishery products subject to HACCP regulations.
- Foods for research or evaluation, foods for personal consumption, alcoholic beverages, and certain ingredients used in alcoholic beverages.
- Foods imported for further processing and future export.
- Low-acid canned foods (LACF), such as canned vegetables—only in relation to microbiological hazards covered by other regulations, and certain ingredients used in LACF products (but only concerning microbiological hazards).
- Certain meat, poultry, and egg products regulated by the USDA at the time of import.
Reliance on Other Entities
The FSVP importer may rely on other entities to perform most standard FSVP requirements, provided the FSVP importer reviews and evaluates the other entity’s work and documents the review and evaluation. This flexibility is intended to assist FSVP importers who are less familiar with food safety, as well as FSVP importers who do not have a direct business relationship with the foreign supplier.
FDA Agent and Workforce Needs
A qualified individual must develop your FSVP and perform each required activity. A qualified individual must have the education, training, or experience (or a combination of these) necessary to perform the assigned activities and must be able to read and understand the language of all records that need to be reviewed when performing an activity.
A qualified auditor must perform any audits conducted in accordance with FDA requirements. A qualified auditor must have the technical expertise obtained through education, training, or experience (or a combination of these) needed to perform the audit function.
Hazard Analysis
An importer must implement a safety and quality control program like HACCP, GFSI, BRC, or another FDA-recognized program.
The importer is required to identify and evaluate, based on their experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food they import to determine if there are hazards requiring control.
As required by their safety and quality control program, the importer must then assess the identified hazards to determine whether any of the identified hazards are “hazards requiring control.” A “hazard requiring control” is defined as a known or reasonably foreseeable hazard for which a knowledgeable person in the safe manufacturing, processing, packing, or holding of food would establish, based on the results of a hazard analysis, one or more controls or measures to significantly minimize or prevent the hazard. The hazard analysis must weigh the likelihood that the hazard will occur in the absence of control measures and the severity of illness or injury if the hazard occurs.
FDA Agent: Food Verification
Supplier Verification
Importers can tailor supplier verification activities to the unique food risks and supplier characteristics. Once the risk assessment is completed, the importer must establish and follow written procedures to ensure, in most cases, that they only import from approved foreign suppliers and conduct appropriate supplier verification activities.
Options include all requirements of their safety and quality control program, such as:
- Annual on-site audits of the supplier’s facilities, conducted by a qualified external auditor.
- Sampling and testing.
- A review of the supplier’s relevant food safety records. An importer may rely on another entity (other than the foreign supplier) to determine and perform the appropriate supplier verification activities, as long as the importer reviews and evaluates the relevant documentation.
When Things Go Wrong
Importers must promptly take appropriate corrective actions if they determine that a foreign supplier has not used processes and procedures that provide the same level of public health protection as required under the produce safety and preventive control regulations, or if the supplier produces food that is adulterated or misbranded concerning allergen labeling.
- The appropriate corrective action will depend on the circumstances but could include stopping the use of the foreign supplier until the cause of the non-compliance, adulteration, or misbranding has been properly addressed.
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