Food Safety Modernization Act are not only Preventive Controls for Human and Animal Food Rules. FSMA consists of series of regulations that pertain to various food type activities. This includes importing human and animal food from foreign countries.
Foreign Supplier Verification Program Regulation is part of FSMA and is addressed under 21CFR Parts 1, 11 & 111.
According to FSVP concept, importers of human and animal food to the U.S. are overall responsible for food safety of incoming food. The purpose of this rule is to assure that food coming into the U.S. meets the same level of public safety that food made here.
Foreign Suppliers and importers were given 2 years to adjust their Programs and collect necessary records. Each importer that is identified as FSVP importer on CBP filing must conduct the following activities according to the rule:
- Conduct hazard analysis of the imported food
- Assess the risk associated with foreign supplier of the food
- Have written procedures for approving foreign suppliers
- Have written procedures for determining verification activities
- Determine, conduct, and document verification activities
All above activities must be conducted by Qualified Individual. According to the definition, Qualified Individuals are individuals with training, experience, or combination of thereof to conduct FSVP activities. Typically, that type of experience comes from years of work within food manufacturing industry on food safety management side. Not too many importers have that.
Food importers struggle with implementing FSVP requirements as imports were never under such a scrutiny. Back in the days one did not need any special qualifications to bring and distribute foreign food. FSMA and FSVP changed everything and now importers are required to conduct activities and collect records they simply do not know much about. With pandemic the number of FSVP inspections by FDA skyrocketed as these could be conducted remotely.
Best way for the importers to prepare for FDA’s regulatory inspection is to educate themselves on food safety. HACCP certification course would be a good start, followed by Preventive Controls Qualified Individual course and Foreign Supplier Verification Program Course. We recognize that it may take time for some to become Qualified Individual and conduct required activities.
Lately, we have been getting a lot of inquiries regarding assistance with FSVP compliance. If you are one of the importers struggling with fulfilling these requirements, please give us a call!