FDA Could Beef Up Food Safety Enforcement Through Inter-Agency Center

FDA expects its work in the Customs and Border Protection's new import tracing analysis center to generate information the agency can assimilate into its own supply-chain tracing capabilities.

CBP's Commercial Targeting and Analysis Center for Import Safety, with support from FDA and other federal agencies, specifically will target shipments of imported cargo, including food, for safety violations, the Department of Homeland Security said Dec. 9.

A spokesman said FDA will work with other federal agencies in the CBP center "to share information, identify and evaluate signals that may indicate a safety concern with an imported product and develop procedures that will maximize resources in order to prevent the duplication of work among the agencies."

The collaboration also will identify additional risks associated with shipments and will lead to the development of rules that will be incorporated into FDA's Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting system.

PREDICT, which FDA began rolling out in September, flags for inspection imports showing the highest likelihood of violating FDA rules and standards (¹ (Also see "FDA's PREDICT Makes Accelerated Entry Likely For Most Imports" - Pink Sheet, 26 Oct, 2009.)).

According to the spokesman, FDA's "evaluation of signals" processed through the CBP center "may indicate immediate follow-up" with PREDICT.

Benjamin England, a former FDA attorney who now heads international import consulting group FDAImports.com in Columbia, Md., expects that in addition to FDA gleaning information for PREDICT, the CBP center could gain from using the system.

"The difficulty in this is how do they figure out if a shipment came from a good place versus a bad place? That's where targeting is important. If that's what they're doing - if they're using the PREDICT system - that's great," England said.

PREDICT is already influencing how FDA conducts import safety enforcement and what importers must be prepared to do for compliance.

"All your registrations and all your listings, even contract manufacturers that before didn't require registration or listing, FDA's looking for it and they're holding up cargo as a result of it," England said.

The center's work likely will have broader impact in changing how firms importing food products - ingredients as well as finished items - maintain supply chain documentation.

While many firms already consistently maintain accurate supply chain information for business purposes, all importers now face a higher likelihood of being asked to provide the information for regulatory inquiries.

"One thing that I'm telling my clients now is that it's important for them to develop internal procedures that ensure the documentation on all of their shipments lines up, that all the dots are connected between the parties involved in the financial transaction, the manufacturing operation and the distribution and transportation," England said.

"It has to be clear that when the information comes to the United States government, that there is nothing that looks like an anomaly."

Step In Cooperation Direction?

The center, one of six CBP operates, appears to be a step in the direction of greater inter-agency cooperation that FDA officials and food and drug industry stakeholders say is needed to improve import safety.

Dietary supplement and import safety experts, however, point out that cross-agency training and communication, in addition to assigning officials from different departments to the same operation, is needed for effective inter-agency food safety enforcement.

The center "has the potential to break down silos, as long as it does not create an additional layer of bureaucracy," said Jennifer McEntire, manager of the Institute of Food Technologists' Science and Technology Projects.

Council for Responsible Nutrition executive Andrew Shao also considers the CBP center a start to removing food-safety collaboration barriers between agencies. But he cautions that training for federal officials in other agencies' import regulations and ongoing communications are needed to make multi-agency efforts effective.

"It is abundantly clear that the silo approach to import safety - for all products, not just food - of different international, federal, state and local authorities working separately is ineffective, so some attempt to align these groups under a single umbrella makes sense," Shao, CRN's VP for scientific and regulatory affairs, said in an e-mail.

Dietary supplement firms have had ingredients held up at ports of entry due to a lack of understanding of applicable laws and regulations by FDA officials, and those problems could be prevented by training and communication between FDA and other agencies.

"This would be a major undertaking requiring substantial resources for education and enforcement to deal with the global supply chain," Shao said.

Different Regulatory Backgrounds

McEntire suggests food safety officials from different agencies approach a multi-agency effort from their own regulatory backgrounds, not with a common enforcement history.

"They're going to be presumably working together. You're bringing people in who come from different agencies, who have different requirements, who operate under different laws and I think it will be interesting to see who ultimately is in charge and who has the final say over things," she said in an interview.

As the host agency, CBP most likely will direct the effort, McEntire observed, adding that "how the other agencies are able to work within that structure I guess is to be determined."

England expects different regulatory backgrounds to continue to impede food safety collaboration among federal agencies.

"To a certain extent, it's a bit of rearranging the deck chairs," England said in an interview. "There's not a whole lot of change I expect from this."

The heightened attention to imports could overshadow the need to maintain scrutiny of domestically made or processed food products, says McEntire, who was the lead researcher in a recent IFT report commissioned by FDA that recommended standardizing ingredient tracing systems for the food industry as a crucial component of enhancing food supply safety (² (Also see "Inconsistencies "Complicate" Food Supply-Chain Tracing - Report" - Pink Sheet, 23 Nov, 2009.)).

The contamination crisis this year that accelerated calls for food safety reform - salmonella-tainted peanuts - was a domestic problem.

"I wouldn't want more attention paid to imports than we pay to products that are sourced or at least processed in the United States," McEntire said.

"I think when we look at what can be done to increase food safety protection, I don't know that it is appropriate to make a distinction between domestic or imports."

Recommended By Working Group

In addition to FDA, the Department of Agriculture's Food Safety and Inspection Service, the Environmental Protection Agency and the Consumer Product Safety Commission will provide expertise at the tracing analysis center, which will be headed by CBP's Office of International Trade and located in Washington, the DHS release says.

President Obama's Food Safety Working Group recommended the center. While some members of Congress and experts have pushed for creating a stand-alone food agency comprising existing divisions of multiple federal agencies, the working group and administration appointees have emphasized improving cooperation and collaboration between agencies with current food safety enforcement and oversight authorities (³ (Also see "Federal-State Food Safety Coordination Becoming A Key Reform Ingredient" - Pink Sheet, 27 Apr, 2009.)).

The working group "identified close cooperation between federal agencies as a key to achieving real progress," Agriculture Secretary Tom Vilsack, co-chair of the group, said in a USDA release.

FDA Commissioner Margaret Hamburg and Principal Deputy Commissioner Josh Sharfstein, in a New England Journal of Medicine article they co-authored, said the agency will collaborate closely with industry and other agencies to establish a modern food-safety system focused on prevention (⁴ (Also see "Hamburg Sees Collaboration As Major Factor In Improving Food Safety" - Pink Sheet, 1 Jun, 2009.)).

A key change in FDA efforts to improve its food safety enforcement came in July with Hamburg's addition of a food safety czar in an agency-wide reorganization. The post has not yet been filled, although leading food safety expert and former FDA policy exec Michael Taylor has been added as a senior advisor on food safety (⁵ (Also see "FDA Creates Food Czar In Agency-Wide Reorganization" - Pink Sheet, 13 Jul, 2009.)).

- Malcolm Spicer ( ⁶ [email protected] )