FDA Should Continue Move to Trusted Trader Programs in Managing Food Safety Risks, Says AAEI

The Food and Drug Administration needs to do more to use the trusted trader model to manage food safety risks, said the American Association of Exporters and Importers. “Moving away from certifying individual transactions to certifying supply chains allows FDA and industry to focus supply chain security resources more effectively, thereby targeting high-risk operators and supply chains,” said AAEI in comments on FDA’s Jan. 16 preventative controls proposal (see 13010429). “Trusted traders are industry leaders in their respective trade as well as leaders in supply chain security and compliance,” AAEI said. “They represent low risk and should not be subjected to the same level or type of oversight as others not so designated.”

The foundation for a trusted trader approach already exists, in the form of the CBP’s Customs-Trade Partnership Against Terrorism, AAEI said. C-TPAT is evidence that “the holistic approach to supply chain risk management has been successful” it said. FDA seems to be moving in that direction. Tentative requirements for participation in the Voluntary Qualified Importer Program include validation as Tier II of C-TPAT, an effective endorsement of the program, AAEI said. “We believe VQIP is a program that could potentially work well with C-TPAT and be of benefit to both private industry and the FDA in terms of reducing pressure on supply chain security resources,” it said. According to AAEI, FDA’s use of the Automated Commercial Environment (ACE) could also allow it to leverage common data elements to move toward a trusted trader model.

FDA should also consider expanding its reliance on trusted traders by extending the “qualified individual” concept from the preventative controls proposed rule to cover qualified companies, AAEI said. Under FDA’s proposal, companies are required to employ qualified individuals to oversee their food safety plans. According to AAEI, the concept of individuals that present a low risk because they work proactively with the U.S. government, if extended to a company scale, “is the very essence of a trusted trader.” By expanding the qualified individual concept to trusted traders, FDA would continue to build on the foundation laid by C-TPAT and VQIP.

“The benefit of low risk is that in the absence of credible, specific intelligence of a threat or potential threat to the food supply, trusted traders will be given exemptions to hazard analysis and risk-based preventative controls at the transactional level,” AAEI said. “This approach would allow FDA to focus scarce resources on those companies and supply chains that are not deemed to be low risk.”