FDA Officials Outline Plans for Coming Qualified Importer Program, Prior Notice, Etc.
HOLLYWOOD, Fla. -- Food and Drug Administration (FDA) Director of Import Operations Domenic Veneziano went into detail in describing the plans for the voluntary qualified importer program (VQIP) while speaking at the National Customs Brokers and Forwarders Association of America April 25, 2012. The plans are still in development, said Veneziano. The VQIP was required as part of the Food Safety Modernization Act.
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Eligibility requirements for the VQIP will include:
- Must be importer with a record.
- Must be in good standing with U.S. Customs and Border Protection.
- Will need to have Tier 2 status with CBP's C-TPAT.
- Foreign Supplier Verification Program (FSVP) importers must be in compliance with provisions of FSVP.
- Applicants can't be subject to FDA action.
Under the VQIP, there will be two levels of participants. Level 1 members will have an adjusted risk score that reduces probability for products to be sampled. Level 2 participants will also have an adjusted risk profile which also reduces the likelihood of products being sampled. Those members will have received expedited lab analysis by FDA. The processes for revocation are still being worked on, as are user fees, he said.
FDA Final Rule on Prior Notice Coming
A final rule on the requirements of prior notice of imported food is being prepared for issuance soon, said Tony Taube, director of the FDA prior notice center. A new Question and Answer guidance is also expected to be released shortly, he said. In a presentation at the convention, Taube described some of the problem areas that have been persistent within the program. Problems include: declared manufacturer not being the actual manufacturer, the manufacturer registration not matching submitted name and address and manufacturer not registered, he said.
The FDA issued an interim final rule that requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. (See ITT’s Online Archives 11050516 and 11090106 for summary of the interim final rule establishing the new PN element on other countries refusing food and FDA stating it would enforce it starting September 6, 2011.)