2 Dec 2016
Expedited Food Import Programme Should Be Launched in FY 2019
The Food and Drug Administration has made available a final guidance for industry on the fee-based Voluntary Qualified Importer Program, which will provide for expedited review and importation of human and animal food by participating importers with a proven track record of food safety and security. The FDA believes that expedited entry under the VQIP will incentivise importers to adopt a robust system of supply chain management and allow the FDA to focus its resources on examining and sampling food imports that are more likely to present a potential risk to public health.
The guidance describes the eligibility criteria for, and benefits of, participation in the VQIP. It also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported under the VQIP, the VQIP user fee, conditions that might result in the revocation of VQIP eligibility, and criteria for reinstatement of eligibility. Importers participating in the VQIP will receive the following benefits.
- The FDA will expedite entry into the United States for all foods included in an approved VQIP application. The agency will set screening in its PREDICT import screening system to recognise shipments of food that are the subject of an approved VQIP application so as to expedite the entry of such food. The system is designed to recognise the information and release the shipment immediately after the receipt of entry information unless examination and sampling are necessary for public health reasons.
- The 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.
- In the examination and/or sampling circumstances identified in the previous bullet, the 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, the FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection to export from the port preferred by the importer.
- The 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.
- The FDA will maintain a VQIP importers help desk dedicated to responding to questions and resolving issues raised by such importers about VQIP food and the agency’s guidance document. The 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.
- The FDA will post a publicly available list of approved VQIP importers on its website, although VQIP importers may choose not to be included on the list. A VQIP importer’s decision to opt out of being listed on the publicly available list of approved importers will not have any effect on its participation.
VQIP benefits will begin on 1 October following an importer’s acceptance into the programme and will last through 30 September of the following year. However, the agency may suspend any or all of these benefits as necessary to protect public health or in the case of an unforeseen emergency.
A VQIP importer may import food from any foreign supplier, provided that supplier is not subject to detention without physical examination under an import alert and has a current food facility certification issued by a third-party certification body accredited under section 808 of the Federal Food, Drug, and Cosmetic Act and in accordance with the FDA’s third-party certification regulation. For the purposes of the VQIP the foreign supplier will be the same as in the foreign supplier verification programme regulation, that is, the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labelling or any similar activity of a de minimis nature.
To maintain eligibility for importation under the VQIP the foreign supplier of a VQIP food must obtain re-certification annually. Further, under the FDA’s third-party certification regulation an accredited certification body may issue a certification for a term of up to one year. Although the FDA anticipates that most foreign supplier facility certifications will have a term of one year, an accredited certification body may find it appropriate in some circumstances to issue the certification for a shorter term (e.g., based on seasonal productions). This may require the facility to be re-audited and re-certified more frequently (e.g., when there are multiple seasonal productions during a year). The importer is responsible for ensuring that all foreign supplier facility certifications on which it relies in its VQIP application are current. The guidance indicates that an importer should co-ordinate with its foreign suppliers to ensure a third-party regulatory audit is conducted and a current facility certification is issued before the expiration of a certification referenced in the importer’s VQIP application.
The FDA plans to begin accepting applications for the VQIP on 1 January 2018 for participation starting in fiscal year 2019, which begins on 1 October 2018. The agency anticipates approving about 200 applications in the first year. The annual fee to be paid by all VQIP participants has been estimated at US$16,400 but has not yet been finalised. The FDA states that it will publish the fee amount in the Federal Register on or before 1 August 2017 and each year thereafter.