Industry News

Trusted Trader Pilot Will Give FDA New Visibility into CTPAT Participation

The coming “Trusted Trader” pilot that will combine parts of the Customs-Trade Partnership Against Terrorism (CTPAT) and the Importer Self Assessment programs, will give the Food and Drug Administration the ability to see the CTPAT status for importers, said Domenic Veneziano, director of FDA Import Operations. Now, the FDA is unable to look at CTPAT 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 CTPAT program has long been limited as it relates to FDA involvement, said Veneziano. “One of the things related to CTPAT that has always been a problem in the past is that I could never find out who was CTPAT 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 CTPAT 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 CTPAT 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 CTPAT, 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.

 CBP outlines Trusted Trader Program here.