FDA Reviewing Cargo Hold Stats, Document Centralization

The Food and Drug Administration (FDA) is beginning work to update its border procedures though reviews of its hold statistics and document review abilities, said John Verbeten, director of the operations and policy branch at the FDA. Verbeten spoke Sept. 10 at the National Customs Brokers and Forwarders Association of America (NCBFAA) Government Affairs conference. It remains unclear exactly how much progress has been made on these efforts and the trade community would like to see more interaction with the agency on the issues, said Express Association of America (EAA) Executive Director Mike Mullen, who has been leading an industry charge to improve FDA's role at the border.

The agency will be taking a good look at PREDICT, the FDA's risk-based screening system for imports, said Verbeten. "I have no interest in stopping good stuff," he said. FDA is now working to get people to come in to take a look at the metrics to find "that right magic formula," that lets goods enter without posing an undue risk to consumers and allows the FDA to do its job, he said.

"We have an assessment team, we have contractors who are looking at what would be our acceptable risk number, meaning if nothing else, it is actually holding that line for us," Verbeten said. If "it's a risk number of, say, 60 or below, the system is just going to release it. So if there's nothing else that's holding it, not an import alert, if there's not some kind of administrative requirement that's not met" the system will release it, he said. Verbeten also came to the defense of PREDICT, noting "overall, on a national basis, that violation rate for things that are being held are higher than the violation rate we had before PREDICT."

Centralized Review

Verbeten also said he's been "tasked with coming up with a plan" for centralized review. "We can, as an agency, centralize some of these decision making processes," he said. That would allow the FDA to be more consistent in its decisions, rather than seeing varying results "district to district," he said. "We're looking into that. We are going to be developing a plan to see how we can test it out," he said.

The FDA also has people from "all the districts" working to develop best practices and come up with national procedures and guidance as part of the Import Operations Strategic Plan. The FDA also hopes to improve things from a communication standpoint, getting useful information about the procedures and contacts out to the industry, Verbeten said. For instance, if a broker is located in Miami and is filing an entry through Los Angeles, the FDA website should provide easily accessible information on who to contact in Los Angeles.

Limited Involvement with Trade

While the reviews mentioned by Verbeten are positives for the import community, so far there's been limited interaction with trade representatives, said Mullen in an interview. Mullen said industry would "like to talk a bit" with the FDA on this and get more detail "before they get too deep in planning." Mullen said he would like to know a little more about "where things stand." The FDA didn't return a request for comment on details on the agency's review of import procedures.

Mullen, who spoke at the NCBFAA conference alongside Verbeten, established earlier this year an industry group that came up with 17 recommendations for the agency. Both a centralized review program and a review of FDA hold statistics were submitted in May by the industry groups as important changes. The group focused on "practical actions" that could be implemented without "big resource commitments or legislation," Mullen said.

Specifically, the FDA should look at the number of shipments being held as a percentage of all shipments subject to FDA regulatory review, and the number of violative products seized as a percentage of those being held. Based on a one-week review of FDA data, a total of 55 percent of FDA regulated shipments were held for review, far more than the number CBP holds, which is typically around 5 percent, said Mullen. Among the most pressing issues FDA should take on include adjusting PREDICT rules to cut holds in half through a "no further action list" and designation of "low risk products," said Mullen. FDA should also move document reviews to post release environment and provide feedback to the importer or filer electronically, the working group recommended.

Email documents@brokerpower.com to see Mullen's presentation or more information on specific working group recommendations.

Legislative Mission Update Needed

There remain some basic issues with the FDA and its position at the border, said Mullen at the conference. Verbeten said FDA’s focus is on consumer protection and “trade facilitation is not in my mission,” though “I’d be a fool if I ignored how important trade facilitation is” and there’s no hope to “hinder trade." But, trade facilitation needs to be included in that mission, said Mullen. The FDA's protection mission is important, but with the "explosion in the number of products that the FDA now regulates and all the significant legislation that has come down the pike in the last decades, it's tremendously expanded [FDA's] role," he said. As a result, the FDA is "having a huge impact on the supply chain, and trade facilitation has got to become part of the mission." Mullen urged the conference attendees to push for a legislative fix, adding trade facilitation to the FDA mission.