The Food Safety Modernization Act (FSMA) plays a large role in global food safety, and the Foreign Supplier Verification Program (FSVP) rule is something every U.S. food importer needs to be compliant with. The rule was created for two reasons: to prevent potentially adulterated food from being imported to the U.S., and to ensure imported food is produced under the same food safety requirements as domestic products. But, is it possible to develop and implement a compliant FSVP without personally visiting foreign suppliers? Absolutely!
The key is to determine what is needed to demonstrate that FSVP requirements are being met. For the most part, the importer’s responsibilities are the same as those of a U.S. manufacturer who sources raw materials and ingredients locally.
The FSVP importer is responsible for verifying that the food or raw materials/ingredients produced by the foreign suppliers are being manufactured, raised, or harvested in accordance with relevant sections of the FD&C Act, depending on the type of food product being imported. The importer will be held responsible by FDA for the food safety of all imported food products, including food-contact substances.
If you are the FSVP importer, then it is important to outline a policy and procedure on how your company is going to verify compliance of your foreign suppliers. A good first step is to align your FSVP with your company’s food safety plan. Using your food safety plan as a guide will help identify the hazards most common to the food products being sourced and the impact these foods may have in your facility. Items to look for include the hazards outlined in the preventive controls rule.
- Biological
- Chemical
- Physical
- Radiological
- Natural toxins
- Pesticides
- Drug residues
- Decomposition
- Parasites
- Allergens
- Unapproved additives
- Intentional adulterants, such as those that fall under Economically Motivated Adulteration
The second step would be a review of the foreign supplier’s own hazard analysis and Food Safety Plan (FSP) to assure compliance with the Preventive Controls Rule requirements. It is important to know the controls that the suppliers have in place for the various hazards common to these imported foods or ingredients. Besides that, the foreign supplier may be relying on a local supplier to apply the necessary preventive control. In such a case, the foreign supplier verification activities must include the local supplier of the foreign supplier as well.
The review of the foreign supplier FSP can be complimented by a supplier survey, which provides valuable background information on the facility’s food safety programs and culture. It also provides important information related to the food safety plan and prerequisite programs. The survey should be as detailed as necessary to provide the information to make critical decisions related to the products. Items to include are:
- Country of origin for sourcing of the materials
- Prerequisites programs to include copies of procedures and examples of records
- Hazard controls such as temperature, water activity, foreign material controls
- Allergens common to the facilities that may or may not impact your facility
- Historical hazards associated with the materials, such as toxins or economical adulterants
The third step would be to undertake a review of the food sanitation and safety compliance history of the foreign suppliers. Information that can be researched and reviewed include:
- Import alerts
- Warning letters
- Recalls
- FDA inspections
- Inspections by the foreign national food safety authorities
- Third party audits
Finally, transportation methods and procedures to ensure proper controls for the food safety integrity of the products need to be considered. The Sanitary Transportation Rule may apply depending on the type of food product being imported (bulk liquid or solid) and whether temperature control is critical for food safety.
