FSVP for Whom and Why
The FSVP regulations apply to all FDA-regulated food imported or offered for import into the United States, with some partial and somewhat minor exemptions. “Food” includes ingredients in food and beverages, food additives and color additives put in food during processing, dietary supplements and packaging and other food contact substances, though there’s a two-year extension FSVP compliance for food contact substances. Food regulated by USDA is not subject to the FSVP regulations.
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.
Reliance on Other Entities
The FSVP importer may rely on other entities to perform most of the standard FSVP requirements, provided the FSVP importer reviews and assesses the other entity’s work and documents its review and assessment. This flexibility is intended to assist FSVP importers that are less knowledgeable about food safety, as well as FSVP importers that do not have a direct commercial relationship with the foreign supplier.
A qualified individual must develop your FSVP and perform each of the activities required under this subpart. A qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities and must be able to read and understand the language of any records that must be reviewed in performing an activity.
A qualified auditor must conduct any audit conducted in accordance with FDA requirements. A qualified auditor must have technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function
An importer must run a Safety and Quality Control Program like HACCP, GFSI, BRC or any other program recognize by FDA.
An importer is required to identify and evaluate—based on experience, illness data, scientific reports and other information—the known or reasonably foreseeable hazards for each type of food it imports to determine if there are any hazards requiring a control.
As required by his Safety and Quality Control Program, the importer then must evaluate the identified hazards to determine whether any of the identified hazards is a “hazard requiring a control.” A “hazard requiring a control” is defined as a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis, establish one or more controls or measures to significantly minimize or prevent the hazard. The hazard evaluation must weigh the probability the hazard will occur in the absence of controls and the severity of the illness or injury if the hazard were to occur.
Importers have the flexibility to tailor supplier verification activities to unique food risks and supplier characteristic. The evaluation of risk conducted, the importer must establish and follow written procedures to ensure, in most instances, that it only imports from approved foreign suppliers and must conduct appropriate supplier verification activities.
The options include all requirement of their Safety and Quality Control Program.
For exemple :
- Annual on-site audits of the supplier’s facility, performed by an external qualify auditor.
- Sampling and testing
- A review of the supplier’s relevant food safety records. An importer can rely on another entity (other than the foreign supplier) to determine and perform appropriate supplier verification activities, so long as the importer reviews and assesses the relevant documentation.
What if Something Goes 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 controls regulations, as applicable, or that the supplier produces food that is adulterated or misbranded with respect to allergen labeling.
• The appropriate corrective measure will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration or misbranding has been adequately addressed.