FDA Releases Final Guidance for Voluntary Qualified Importer Program

The U.S. Food and Drug Administration is announcing final guidance for industry for a voluntary, fee-based program to allow the expedited review and importation of foods into the United States from importers with a proven track record of food safety and security. The final guidance is in question-and-answer format to explain how this program will work.

In particular the document address the following points:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

The Food Safety Modernization Act (FSMA), indeed, required FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes importation of food from facilities that have been certified in accordance with FDA’s program for Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (see FDA’s third-party certification regulations at 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import. Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

Speaking of benefits for companies, they will be the following:

• FDA will expedite entry into the United States for all foods included in an approved VQIP application (VQIP foods). FDA will set screening in its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening system to recognize shipments of food which are the subject of an approved VQIP application to expedite the entry of such food. The system is designed to recognize the information and release the shipment immediately after the receipt of entry information, unless examination and sampling are necessary for public health reasons. (See Question A.5.)

• FDA will limit examination and/or sampling of VQIP food entries to “for cause” situations (i.e., when the food is or may be associated with a risk to the public health), to obtain statistically necessary risk-based microbiological samples, and to audit VQIP. (See Question A.5.)

• In the examination and/or sampling circumstances identified in the previous bullet, FDA will attempt, to the extent possible, to examine an entry and collect samples at the VQIP food destination or other location preferred by the VQIP importer. If exportation is warranted, FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection (CBP) to export from the port preferred by the importer.

• FDA will expedite its laboratory analysis of “for cause” or audit samples of VQIP entries, to the extent possible in accordance with public health priorities.

• FDA will maintain a VQIP Importers Help Desk dedicated to responding to questions and resolving issues raised by VQIP importers about VQIP food and this guidance document. The VQIP Importers Help Desk will be available for assistance with completing the VQIP application and facilitating review of VQIP food that does not receive an immediate release.

• FDA will post a publicly available list of approved VQIP importers on FDA’s VQIP Web page. VQIP importers may choose not to be listed on the VQIP importers list. A VQIP importer’s decision to opt out of being listed on the publicly available list of approved VQIP importers will not have any effect on its participation.

Additional Information

 

FDA improvements to food recall system – Learn from SCORE team

Very interesting developments from USA Food & Drug Administration webpage:

“Six months ago, the FDA moved to speed its response when there are foods on the market that present a real or potential danger to consumers’ health.

The agency created a team of key senior leaders to get involved with the most challenging recall situations, those complicated by such issues as the nature of the product, the scope of available evidence, and the company’s response. This team is called SCORE (Strategic Coordinated Oversight of Recall Execution).

SCORE is already making a difference, helping to overcome obstacles and streamlining processes to get potentially harmful foods off the market as soon as possible to reduce further consumer exposure.

William Correll, director of the Office of Compliance in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Douglas Stearn, director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs (ORA), are the SCORE co-chairs. They talk about what SCORE has achieved in its first six months, the challenges it has faced, and the road ahead.

And in an FDA Voice blog, Stephen Ostroff, Deputy Commissioner for Foods and Veterinary Medicine, and Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy, talk about SCORE’s role in complex recalls.”