Food Imports: How to Increase Safety — Regardless of Origin

A qualified individual is someone hired on a full-time basis or sought through an external resource to help you:

• Document and implement the hazard analysis, verification activities, and corrective actions;
• Conduct performance evaluation of foreign suppliers;
• Approve suppliers;
• Reevaluate FSVP and documentation;
• Perform on-site supplier verification activities; and
• Maintain up-to-date records.

Certification audits conducted according to the program may be used to satisfy the onsite audit activity requirement for supplier verification. Supplier certificates must be maintained as records to demonstrate compliance with FSVP.

When the FDA Third-Party Accredited Certification is used to satisfy FSVP requirements, it provides the opportunity to reduce audit burden and conserves human and financial resources related to repetitive or redundant customer audits. The audit against the applicable FDA regulations for the product scope may be conducted in conjunction with a current certification program, such as a Global Food Safety Initiative (GFSI) benchmarked food safety program, to ensure any gaps between the existing program and the FDA requirements are fully evaluated.

Voluntary Qualified Importer Program

VQIP, a voluntary fee-based program, provides expedited review and import entry of food brought into the U.S. for participating importers. Participating importers benefit from increased speed and predictability at U.S. points-of-entry. Consumers benefit from increased safety and security of imported foods.

VQIP suppliers must be certified by a certification body accredited under the FDA Third-Party Accredited Certification Program. A supplier site may choose to have a third-party consultative audit prior to the certification audit to help the site prepare. Consultative audits are not available from accredited certification bodies and may not be used for certification.

VQIP benefits for importers include:

• Quicker, easier market entry for imported goods;
• Limited examination and sampling;
• FDA sampling at importer’s preferred location; and
• Faster test results.

FDA High-Risk Import Certification

FDA may determine a foreign supplier or food product is high risk and mandate import certification (IC) by a Certification Body accredited under the FDA Third-Party Accredited Certification Program. FDA does not maintain a register or list of high-risk products, but may designate this status in the event of an ongoing food safety incident, as a result of field sampling, or in response to elevated risk to food safety due to geopolitical or natural events.

If FDA designates a product as high risk requiring import certification, the supplier would be notified by FDA and the site would choose the accredited certification body to perform the certification in order to qualify for import. The imported product must be accompanied by the certificate and be listed by the certification body on its public listing of certified sites.

Regardless of the reason for the certification, foreign suppliers and importers should remember:

• All accredited certification audits for VQIP suppliers and FDA high-risk imports are unannounced;
• FDA may mandate an import certification for high-risk products as a condition of import, unrelated to VQIP or FSVP;
• If a supplier undertakes a VQIP or IC audit by an accredited certifier, its audit information is shared with FDA, and it is listed publicly for its certification status and authorized products for import;
• Audit information for VQIP suppliers and FDA IC imports is subject to public disclosure under the Freedom of Information Act;
• If a VQIP or IC supplier is involved in a recall, the certification is immediately suspended pending further investigation;
• If a certification body observes a critical food safety hazard at the certified site, FDA is immediately notified, the certification audit is stopped, and certification is suspended;
• Importers and suppliers must maintain clean food safety records for the three years immediately preceding certification; and
• Mixed loads of certified and non-certified products for VQIP imports will be detained in order to separate the load.

Accreditation and Certification Process

FDA authorized independent accreditation bodies to assess the program integrity for those certification bodies that have applied for and achieved accreditation under this program. The certification bodies currently accredited are listed on the FDA website as well as with the accreditation bodies (ANSI, ANAB, IAS, etc.).