FDA TO RECOGNIZE TRUSTED TRADER C-TPAT

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The coming “Trusted Trader” pilot that will combine parts of the Customs-Trade Partnership Against
Terrorism (C-TPAT) and the Importer Self Assessment programs, will give the Food and Drug
Administration the ability to see the C-TPAT status for importers, said Domenic Veneziano, director of
FDA Import Operations. Now, the FDA is unable to look at C-TPAT status for importers because it’s a
voluntary program, he said. The new access within the pilot program will give FDA another tool to
consider the risks associated with imports of food and other commodities, he said. Veneziano and other
government officials spoke June 12 at the Import Compliance and Enforcement forum put on by the
American Conference Institute.
The C-TPAT program has long been limited as it relates to FDA involvement, said Veneziano. “One of
the things related to C-TPAT that has always been a problem in the past is that I could never find out
who was C-TPAT certified and who wasn’t,” he said. The new pilot “will allow FDA to get that
information,” he said. A Federal Register notice announcing the program was originally scheduled for
September 2013, but was pushed back to the end of 2013 before again being postponed to allow for
participation by the FDA and the Consumer Product Safety Commission (see 13052032, 13111920 and
14021819). The long-delayed pilot is hoped to allow for a single validation and management approach
(see 12120321). Veneziano also noted that C-TPAT tier II or III certification is a prerequisite for
participation in the FDA’s pharmaceuticals Secure Supply Chain pilot program (see 14022015, another
example of FDA’s increased role within the C-TPAT program, he said.
There are still some obstacles and much work to be done between FDA, CBP and Advisory Committee
on the Commercial Operations of CBP (COAC) to better understand the different missions and
requirements involved in C-TPAT, he said. FDA is also working to complete its memorandum of
understanding with CBP that will allow for the sharing of information and eventual implementation of the
International Trade Data System, which is meant to allow for import filing for government agencies to go
through a “single window,” rather than having to submit multiple documents with similar information.
FDA is required to complete the MOU by July and there are some ongoing “negotiations” taking place
to get that completed by then, he said. Other government agency MOUs have been a significant
roadblock to ITDS progress in recent years, though the issue recently gained some momentum when
President Barack Obama issued an executive order earlier this year mandating completion of ITDS by
2016 (see 14021928).
FDA has also been working closely with CBP related to the Centers for Excellence and Expertise, he
said. With the program and FDA involvement is still in its “infancy,” some things are still being worked,
he said. So far, there are already several “co-locations,” allowing FDA to be even more closely involved,
said Veneziano. He also pointed out that FDA recently renewed its commitment within the Commercial
Targeting and Analysis Center, which illustrates FDA’s continued collaboration with CBP. Asked about
some communications issues on foreign trade zone weekly filings, Veneziano said the process can
take up significant agency resources and there’s been some recent discussion as to the extent the FDA
should continue to be in the business of the weekly filings, he said.

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