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

 

Commission launches IT tool to boost cooperation on possible fraudulent practices

The European Commission has today launched a dedicated IT tool, on the ground of articles 34-40 Reg. (EC) No 882/2004, known as the Administrative Assistance and Cooperation (AAC) system to facilitate the exchange of administrative information between national authorities working to combat cross-border violations in Europe.

In the wake of the horsemeat scandal of 2013, the Commission developed an action plan to strengthen controls of the food supply chain. One of these measures was to set up a pan-European mechanism to ensure the rapid exchange of information between national authorities and the Commission in cases of suspected food fraud cases. As a result, the European Food Fraud Network (FFN) was born and tasked with handling requests for cross-border cooperation. Each Member State has appointed a contact point to handle requests from contact points in the other Member States that form part of the network. This network has been operational since July 2013 and since its creation, the Commission has observed a marked increase in the number of exchanges from 30 in 2013 to 90 so far in 2015, adding up to 180 cases in total since its creation.

Cross border cooperation helps to improve the capability of national authorities to:

  • detect and prevent cross border breaches of EU food chain rules; and if necessary
  • collect the information that is needed to refer a case for further investigation and to ensure appropriate enforcement action

The AAC system will ensure that the Food Fraud Network works even more efficiently and is able to respond more swiftly to information requests.

The Activity Report of the FFN for 2014 reveals that exchanges on suspected frauds mostly relate to mislabelling (for instance with regard to date marking, adding water or ingredients), falsified certification and/or documents and substitution, such as replacement of a higher value species with a lower value species (for example substituting pollock for cod). Importantly, however, statistical conclusions cannot be drawn from these data given that Member States may also exchange information outside of the FFN and that cases which do not have a cross-border dimension, i.e. which occur at purely national level, are not exchanged via the Network.

Next steps and main issues

The system will be used in the first phase by the Food Fraud Network. At a later stage, it will be made available also to the liaison bodies working on cases of Administrative Assistance and Cooperation not related to fraudulent practices.

The details about the AAC systems are provided by Commission Implementing Decision (EU) No 2015/1918, establishing the Administrative Assistance and Cooperation system (‘AAC system’) pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, published on the Official Journal of the European Union on 22nd October 2015.

Key points for a smooth functioning of the systems will be:

  • coordination with other existing IT systems, namely RASFF and TRACES;
  • confidentiality.

On the first point, the whereas (9) of the Decision is clear:

“In certain cases, information concerning non-compliance with food or feed law is disseminated by and among the competent authorities in the Member States through the Rapid Alert System for Food and Feed (RASFF), established in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the Council , and through the Trade Control and Expert System (TRACES), established by Commission Decision 2004/292/EC. In order to avoid unnecessary duplication, that information should be made available through the AAC system to the liaison bodies designated in accordance with Regulation (EC) No 882/2004, so that the Member State notifying that information to the RASFF or TRACES is not required to upload the same information onto the AAC system for the purposes of administrative assistance and cooperation. Accordingly, the RASFF and TRACES applications should be enabled to provide data to the AAC system in order to streamline the process.”

Regarding data protection and security, art. 10-12 provide a general framework, which is well summarized in the whereas (13) of the Decision. These provisions are necessary to ensure an effective investigative and prosecution activity:

“Where the exchange of information provided for in Regulation (EC) No 882/2004 and in this Decision involves the processing of personal data, a careful assessment should be carried out to ensure that the processing is strictly necessary to achieve the purposes of efficient administrative assistance and cooperation, and that such processing is in accordance with the national provisions implementing Directive 95/46/EC of the European Parliament and of the Council and with Regulation (EC) No 45/2001 of the European Parliament and of the Council.

Where exemptions and restrictions of certain rights of the data subjects and obligations of the data controller laid down by Directive 95/46/EC and Regulation (EC) No 45/2001 are considered in order to safeguard the interests referred to in Article 13(1)(d) and (f) of Directive 95/46/EC and in Article 20(1)(a) and (e) of Regulation (EC) No 45/2001, those exemptions and restrictions may only be adopted if they are necessary and proportionate to the objective pursued.

Restrictions to the rights of data subjects should constitute a necessary measure to prevent interference with the official control tasks of the competent authorities and with the assessment of compliance with food law or feed law.

In particular, rights of the data subjects may be restricted, in accordance with Directive 95/46/EC and Regulation (EC) No 45/2001, during the period in which actions are carried out for the purpose of sighting or discrete surveillance, where granting them would jeopardise or undermine the purpose of official controls or investigations.

In order to guarantee a high level of data protection, it is appropriate to establish a maximum timeframe to ensure that personal data do not remain in the AAC system longer than it is necessary to achieve compliance with the rules laid down in Title IV of Regulation (EC) No 882/2004. In particular, a retention period of 5 years, starting from the closure of the administrative assistance and cooperation procedure, should be established, after which time personal data should be removed from the AAC system. The length of the retention period is necessary to give the possibility to the liaison bodies and the Commission to consult the information over a sufficient period of time after the administrative assistance and cooperation procedure has been closed, in order to ascertain the timely identification of reoccurring, connected or widespread non-compliance with food or feed law.”