Who needs to comply with FSVP
There are strict requirements for record keeping and training that importers, brokers, exporters and foreign suppliers must comply with under FSMA Foreign Supplier Verification Program. Some exemptions and modifications are allowed for:
- Small importers
- Foods covered under other food safety regulations (such as Juice HACCP)
If you are unsure whether you are required to comply with FSVP rules, the FDA has a flow sheet to help you determine your status.
Foreign Supplier Verification Program Compliance requirements
The first compliance dates for FSVP were May 2017. FDA has already begun inspection activities and issued warning letters to firms that were non-compliant.
To stay compliant, importers must establish and follow written procedures to assure that foreign suppliers are evaluated for food safety hazards. They must develop a FSVP for each food brought into the United States. This means that every foreign supplier of a food ingredient must undergo a hazard assessment and implement preventive controls. After establishing preventive controls, re-evaluation must happen every three years.
Just like preventive control regulations, a qualified individual will need to identify and evaluate imported foods for biological, chemical and physical hazards. Things to consider when making this analysis will be:
- Formulation of food
- Condition, function and design of facility and equipment
- Raw materials
- Transportation practices
- Harvesting, raising, manufacturing, processing and packing procedures
- Packaging and labeling activities
- Storage and distribution
- Intended use
- Sanitation and employee hygiene
A complete plan includes an evaluation for harm or illness posed by an imported food, the supplier’s performance, verification activities and appropriate corrective action plans.
More details on FSVP compliance:
- At a Glance FDA fact sheet
- Final Rule on Foreign Supplier Verification Programs
- FSMA Technical Assistance Network (TAN)
Preparing for Inspections
FSMA inspections are not merely observations of food production, but also a record review. FDA Consumer Food Safety Officers will check to see that you developed, maintained and followed the Foreign Supplier Verification Program for each food brought into the United States. Additionally, they will confirm there is a FSVP for each of the suppliers. Record keeping is one of the biggest changes resulting from FSMA regulations.
Global impact
Importers that bring in foods from countries which have food safety systems comparable to the United States have less rigorous requirements under FSVP. We should expect countries in the European Commission to have food safety laws that are comparable or better. The European Union has prioritized food safety and has even proposed an amendment to current laws increasing the transparency of risk assessment. We should prepare for more food safety requirements in risk assessment, management and communication.
