Small importers and producers raise FSVP compliance concerns

Meetings were held in June in Costa Mesa; California, Rutherford; New Jersey and Detroit; Michigan and involved 350 importers, producers and foreign and industry association representatives.

They covered import safety programs under the Food Safety Modernization Act (FSMA), including the Foreign Supplier Verification Programs (FSVPs), Accredited Third-Party Certification and the Voluntary Qualified Importer Program (VQIP).

Small businesses expressed concern​ that they do not have the resources to participate in VQIP, to educate foreign suppliers on the requirements of FSVP, or thoroughly research and understand FSVP requirements.

FDA said small and mid-sized importers may benefit from additional support, education and outreach to ensure industry-wide FSVP compliance.

Verification activities to ensure safe food​

Most participants indicated they have their own plan, using some industry-recognized processes or methods, such as Hazard Analysis Critical Control Point (HACCP) plans, Global Food Safety Initiative (GFSI) schemes, or other programs to verify the safety of food being imported into the US.

Importers also indicated they rely on assertions (import letters, letters of guarantee, etc.), certifications (Certificates of Analysis (COAs)), and other forms of documentation (supplier hazard or risk documentation) provided directly by the suppliers asserting the food they are selling is safe.

The third most cited verification activity was onsite supplier audits.

Participants said they perform risk reviews and assessments of the products, manufacturers, markets and countries from which they import foods.

The most common risk-monitoring activities included hazard analyses, monitoring news, reviewing public records, analyzing hazard and risk data, and reviewing ingredients of their imported products on a periodic basis. Product testing was the fifth most-cited activity.

While participants described different testing techniques and methods, most testing activities were direct product testing, test data reviews, border inspections and inspections upon arrival.

Reviewing foreign supplier food safety plans or programs was the least-cited verification activity and typically was part of a supplier approval program or as regularly scheduled review of supplier plans or supplier programs and data.

Only 50% of those who took the self-assessments indicated they were ready to prepare and maintain an FSVP on each food for each foreign supplier.

Just more than half indicated they were aware of exemptions and modified requirements of FSVP and knew how to respond in an appropriate manner.

Most participants indicated they need an increased understanding of FSVP requirements to comply fully. This ranged from importers unsure how to identify the importer of record, unsure who could perform hazard analyses and how they must be conducted and participants unclear whether FSVP is required for every product.

Participants expressed challenges with knowing how much verification and hazard analysis activity was necessary, how much and how long records-keeping activities were necessary, how frequently verification activities must occur and others related to understanding FDA’s expectations.

VQIP participation​

Most participants expressed hesitations based on the effort that may be required to apply for participation in the program, which will provide expedited clearance to qualified participants.

Cost of participation and uncertainty around return on investment (ROI) were other areas identified.

Most importers said it was the boost in reputation and credibility in the eyes of customers and the FDA that appealed to them most as motivations for wanting to participate.