By Ricardo Carvajal –
As directed under FSMA, FDA issued draft guidance on its approach to implementation of the Voluntary Qualified Importer Program (VQIP). In exchange for voluntarily subjecting themselves to an initial round of heightened scrutiny, importers who are approved for participation in the program can expect a range of benefits that could have a significant commercial impact. The Q&A section of the draft guidance begins with a focus on those benefits, to include:
- Expedited entry for all foods included in an approved VQIP application – in essence, immediate release of shipments “unless examination and sampling are necessary for public health reasons”;
- Examination and sampling limited 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”;
- Examination and sampling at the location preferred by the importer;
- Expedited laboratory analysis of “for cause” or audit samples “to the extent possible in accordance with public health priorities”; and
- Access to a VQIP Importers Help Desk.
The benefits described above have obvious appeal to any importer that has experienced a disruption of its operations as a result of an FDA hold on an imported food shipment. However, as the remainder of the draft guidance makes clear, those benefits won’t come cheap. There are numerous eligibility criteria that must be satisfied, but the ones that we believe merit greatest attention are these:
- Neither the importer nor any non-applicant entities associated with the food can be “subject to an ongoing FDA administrative or judicial action…, or have a history of significant noncompliances relating to food safety” (“non-applicant entities” are defined as “those entities associated with a VQIP food that conduct activities throughout the supply chain necessary for ensuring that the eligibility requirements of VQIP are met,” and include the FSVP or HACCP importer, the foreign supplier, and the filer/broker);
- Demonstration of compliance with supplier verification “and other importer responsibilities under the applicable FSVP, juice HACCP, or seafood HACCP regulations”; and
- Development and implementation of a VQIP Quality Assurance Program (QAP).
The first criterion described above suggests that a fair amount of due diligence will be expected on the part of any importer that hopes to gain approval. The second criterion essentially summarizes what will be required under the Foreign Supplier Verification Program. But the third criterion is where the rubber really meets the road. The QAP is described as “a compilation of the written policies and procedures you will use to ensure adequate control over the safety and security of the foods you import,” and must include the following “as applicable”:
- Corporate quality policy statement that relates to “food safety and security throughout the supply chain,” and an explanation of how it is communicated to and understood by all non-applicant entities involved in implementation;
- Organizational structure and functional responsibilities for the importer, and functional responsibilities for non-applicant entities;
- Food safety policies and procedures implemented to ensure food safety “from source to entry”;
- Food defense policies and procedures, including “procedures for controlling the safety and security of each VQIP food throughout the transportation supply chain”;
- Experience and training for responsible employees;
- Procedures for ensuring QAP implementation, and auditing and updating as needed;
- Records “relating to the structure, processes, procedures, and implementation of the QAP,” which must be made available to FDA upon request; and
- References relied on in development and implementation of the QAP.
It seems clear that development and implementation of a QAP that will pass muster with FDA will be a resource-intensive endeavor. It may be impossible to anticipate how many importers will be willing to take on that burden (and also bear the other costs, including the estimated annual fee of @ $16k) in exchange for the benefits promised by FDA. In any case, FDA plans to limit the number of applications in the first year of operation to approximately 200, depending on the agency’s resources. Whether that limit is reached could prove to be a good indicator of whether FDA has struck the right balance between benefits and costs of participation.
Comments on the draft guidance are due by August 19.