The foreign supplier verification program (FSVP) was established to ensure that imported foods meet the same high standard of safety as is required by foods produced domestically. This is important since the United States is a huge importer of foods from over 150 countries and 275,000 facilities from around the world representing about 15% of the US food supply. The rule places the responsibility for imported foods on the importer. The importer could be the owner of the food, the person contracted to ship the food (called the consignee), or the US agent of the foreign supplier.
Exemptions from this program applies to:
- Low acid canned foods (for microbial hazards) and foods that are under previous regulatory requirement to have a HACCP plan, since they already have a FSVP in place
- Food imported for research or evaluation
- Food for personal consumption
- Foods shipped for further processing
- Alcoholic beverages
- Meat, poultry and egg products regulated by the USDA
Standard FSVP requirements include:
- Hazard analysis and risk assessment
- Supplier verification
- Corrective actions
- Record keeping
Hazard Analysis and Risk Assessment
Before approving a foreign supplier, the importer must determine that the supplier is capable of providing foods that are safe and meet the standards of foods sold domestically in the US. This requires a hazard analysis and risk assessment which includes identification of hazards based on experience, illness data, scientific reports and other information. Considerations must include:
- Raw materials
- Food formulation
- Facilities and equipment
- Processing steps
- Packaging and labeling
- Transportation and storage practices
- Prerequisite programs
- Compliance with relevant FDA food safety regulations
- Food safety history, including responsiveness in correcting problems in the past
The importer may conduct the hazard analysis or rely on a qualified and independent third party which may include the regulatory authority in the foreign country. In the case of the latter, the importer would only need to review and verify the documentation. If the hazard is controlled by the importer, the importer must demonstrate through written documentation that it has established control procedures and is following them to prevent the hazard of concern. If the hazard is controlled by the customer of the importer, the importer must disclose written documentation accompanying the food that the food is “not processed to control (the identified) hazard”, and must obtain from the customer on an annual basis a written assurance that he has established and is following steps to minimize or prevent the hazard.
An annual onsite audit is required when there is a reasonable probability that exposure to the food hazard of interest could cause severe adverse health consequences or death to humans or animals (SAHCODHA). Alternately, the importer may choose another means of verification as long as he is able to demonstrate that it is adequate to assure food safety. Other verification methods may include sampling and testing, and review of relevant food safety records. As with the preventive controls rule, the FDA has established that the FSVP must be reevaluated at least every three 3 years to determine if new hazards pose potential risks with the food or foreign supplier of the food.
The importer must take corrections in the case that the foreign supplier is found to be in violation of the rule or if there are new concerns. For example if there are significant complaints, if the food is found to be adulterated or misbranded, or if regulatory inspections find significant non-compliance.
As with the preventive controls rule, proper records must be kept. These may be in the form of written signed original copies or electronic copies. Records must be kept for up to 2 years after they were created and be ready for FDA inspection on request. Separate FSVP is required if different suppliers are used.