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

 

FVO report – India – Microbiological contamination in seeds for human consumption

This report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in India from 9 to 17 December 2014. The objectives of the audit were to evaluate the control systems in place to control microbiological contamination in seeds for human consumption (in particular Salmonella contamination of sesame seeds as well as seeds for sprouting e.g mung beans and other seeds for sprouting) intended for export to the European Union (EU) in the framework of Regulations (EC) No 178/2002 and No 852/2004. The evaluation of procedures in place for certification for imports into the EU of seeds for the production of sprouts as required by Regulation (EU) No 211/2013 was also assessed.

This FVO audit to India on the microbiological controls of sesame seeds was undertaken as part of the 2014 FVO audit programme due to the number of Rapid Alert System for Food and Feed (RASFF) notifications linked to this issue.

There is no requirement for exporters of sesame seeds to the EU to be registered with the Shellac and Forest Products Export Promotion Council (SHEFEXIL), the competent authority responsible for sesame seeds. A number of exporters who were mentioned in RASFF notifications were not members of SHEFEXIL and could not be followed up by SHEFEXIL.

A number of consignments that were tested and found to be Salmonella and E. coli free prior to shipment from India were found to be Salmonella positive in the EU.

Overall, there are a number of significant gaps in existence which cannot assure that sesame seeds exported to the EU are safe. The CA responsible for sesame seeds, SHEFEXIL, does not carry out any controls on growers, processors or exporters of sesame seed. In addition, there is a failure to follow up RASFF notifications relating to sesame seeds in India. This is mainly due to a lack of coordination between the Ministry of Commerce and Industry which is the national contact point for RASFF in India and SHEFEXIL, which is responsible for following up on RASFF notifications relating to sesame seeds. Laboratories visited were capable of undertaking the relevant testing for Salmonella detection. However, the approach to sampling of consignments for microbiological testing prior to export could not ensure statistical representativeness.

The Agricultural and Processed Food Products Export Development Authority (APEDA) confirmed that they are the CA for sprouted seeds and seeds for sprouting. APEDA is aware of the certification requirements for imports into the EU of sprouts and seeds intended for the production of sprouts as required by Regulation (EU) No 211/2013. APEDA has received no requests from exporters for such certification to date, thus no certificates have been issued.