FDA criticized for skipping meeting on agricultural imports
A U.S. federal advisory group with a new focus on the importation of agricultural goods identified its top concerns at a meeting on Friday, but no Food and Drug Administration officials were present to hear the feedback, drawing the ire of a few of the industry representatives on the panel.
In its first public action since its creation in February, the agriculture subcommittee of the Advisory Committee on Commercial Operations of Customs and Border Protection listed at least a dozen concerns surrounding implementation of the Bioterrorism Act for electronically filing advance notice of imports and registering food facilities. The requirements went into effect in December and FDA, with the assistance of Customs, is phasing in enforcement of the regulations, which can result in food shipments being held and civil penalties if food importers fail to comply. Many importers are complaining that shipments are being rejected or held at U.S. ports because of technical problems or misunderstandings that are causing incomplete, inaccurate or late filings, as well as difficulties in getting confirmation notices from FDA necessary to enter the goods.
The absence of FDA officials at the meeting served to harden perceptions among importers that the agency is more interested in enforcement than collaboratively working with industry and Customs and Border Protection to lessen the burden of complying with new bioterror rules. From 20 to 40 percent of all cargo moving into the United States is subject to the bioterror regulations.
COAC member Jim Finnegan lambasted FDA for not taking trade facilitation as seriously as Customs to ensure U.S. industry is not harmed by security rules. FDA signed an agreement to work through Customs to enforce the bioterror rules one year ago.
“I’m surprised that we cannot get an FDA representative here. I believe that the organization has more than one employee,” said Finnegan, director of trade compliance for Philadelphia-based Kulicke & Soffa. “Here we are one year later. And we continue to cost a lot of money to the trade and consumers because the FDA continues to cause a bottleneck.”
Unless FDA officials get involved with COAC they will never understand the impact the agency is having on international trade, he said. FDA’s behavior is wiping out the positive results of Customs’ efforts to listen to industry concerns and balance enforcement requirements with commercial trade realities, Finnegan said. If goods don’t move the name of the agency that held up the shipment doesn’t matter to industry.
“Unfortunately, crossing the border is crossing the border. Trade is trade. And the government is the government,” he said, adding that Customs ultimately has the responsibility to coordinate the government response to border issues and get FDA to be a team player.
Customs and Border Protection is the premier border protection agency, “but we have these agencies with independent regulatory authority to set methods, data expectations and supply chain cycle times to get goods into the United States,” Finnegan told American Shipper after the meeting. “Every agency needs to be at the supply chain table because each is impacting the supply chain cycle time.”
Carol Fuchs, head of the agriculture subcommittee and a trade lawyer with KMZ Rosenman, took the blame for FDA’s absence, saying she suggested to the FDA official involved that she thought it would be more valuable that they have a private meeting to try and work out some of the substantive implementation difficulties, rather than having the official attend the meeting. Fuchs acknowledged it was difficult at first to get the FDA and the U.S. Department of Agriculture, which sets policy for plant and animal inspectors working within Customs, to respond to the subcommittee, but felt encouraged that the group finally has their ear.
COAC member Thomas Travis, a partner in the law firm Sandler, Travis and Rosenberg, rebuked Fuchs for disinviting FDA, and said he hoped it would not serve as a precedent for other agencies to limit contact with COAC and especially its new container security subcommittee.
“We have to be inclusive because everyone of these issues that we are going to discuss impacts agencies which you (Customs) enforce laws for,” he said. “If we are going to have committees, we need to have that openness to ensure that those committees do not shield the participation of a critical agency to your mission and to our constituencies. We are supposed to air issues and get collaboration.”
The Department of Homeland Security was created to improve cooperation and coalesce efforts among agencies with domestic security responsibilities and COAC was reassigned as an advisory body to DHS to add dialogue with agencies that have an impact on the flow of goods in and out of the country, Travis said.
“It’s not that we’d like to have them attend. They have to be here,” he said.
FDA participated with Customs in many internal working groups and public discussions to develop the bioterrorism rules and Customs will continue to engage with FDA to iron out implementation issues, said Jayson Ahern, assistant commissioner for field operations.
Stuart Verdrey, assistant secretary for policy and planning in the border and transportation security directorate of the Department of Homeland Security, promised to make sure FDA and all appropriate government agencies attend future COAC meetings.
During her presentation, Fuchs cited information sharing among agencies and data requirements as the areas of greatest concern to food importers, especially as the government seeks more commercial shipping data from companies for security purposes. Food importers with which the subcommittee consulted expressed “lots of frustration with multiple requirements, overlap, different agencies requiring different data, and different agencies requiring the same data but in different formats.”
The subcommittee plans to put together a matrix outlining all the different regulatory permutations from each agency to help government officials and industry better understand their respective roles, she said. The group hopes some follow-on agreements to an interagency memorandum of understanding to implement the bioterror law will help to better clarify the roles of Customs and Border Protection and its Animal and Plant Health Inspection Service, the USDA and the FDA. She indicated that the confusion is restricting some types of information exchange between the agencies and slowing background exams on personnel that need access to the data to do their jobs.
Along those lines, the agriculture subcommittee expressed strong support for the development of the International Trade Data System (ITDS) to serve as the communication datalink between multiple agencies and that as many agencies possible participate.
“I really do look forward to the matrix that will be done by the subcommittee to see what data elements are being required and to where we can actually reduce some of the redundancy and avoid some of the unnecessary data input if we already have that being collected elsewhere,” Ahern told COAC. He said three of the prime drivers pushing ITDS within the government are Customs, FDA and USDA and that other agencies with jurisdiction over international trade need to be brought into the network.
Other areas that Fuchs and the agriculture subcommittee, which includes representatives from government and industry, want addressed include:
* Lack of access to ports by USDA personnel due to Customs security restrictions.
* Expanded use at more ports of an agriculture ombudsman, similar to the one in Miami, dedicated to dealing with complaints about government handling of agriculture imports. The subcommittee plans to draft recommendations on specific locations and situations where an ombudsman would be helpful.
* More interagency meetings at the port level to discuss issues and iron out difficulties that affect the trade community.
* Technical issues associated with complying with the FDA’s prior notice requirements, such as delays getting into the FDA’s Web-based prior notice filing system during peak usage periods, delays in transmission when the system goes down, whether single submissions could be allowed for consolidated shipments from multiple producers and sources, and making possible exceptions to the prior notice requirement for sending trade samples and small value inter-company shipments;
* Lack of adequate FDA staffing and work hours at some ports to help clear shipments.
* The desire to start stationing U.S. inspectors in Mexico, as they are in Canada, in accordance with the 22-point action plan signed by the U.S. and Mexico in 2002.
* Concern that agriculture user fees are going up and that the fees are not enough to cover the costs of customs clearance.
* Concern that the burden of pest and disease control is falling more and more on states as the federal government cuts back its level of activity in this area, and that some dangerous pests and diseases may not be eradicated soon enough before they damage domestic food sources. The group suggested that state personnel be allowed to participate in federal training programs as one way to beef up front-line capability.
The anxiety of the trade community about the technical capabilities of the Customs and FDA computer systems was amplified a couple of weeks ago when the Customs’ system for communicating with FDA severed its connection to the Automated Broker Interface and the main Customs database. Importers and their agents are filing about 20,000 prior notices per day — about 80 percent of the total number — through the existing ABI system for transmitting entry data to Customs, according to Customs officials.
The outage forced all filers, including brokers, to file transactions through the FDA’s Web-based prior notice system. Although FDA says its system can handle any amount of traffic, it can take hours or days to get a response from the FDA system, said Cathy Sauceda, Customs' director for special enforcement.
COAC member John Peterson, who heads the Los Angeles brokerage office of C.H. Powell Co., said in a brief interview that the FDA prior notice Web site is so busy sometimes it is impossible to get on the system to file prior notices. Another industry official familiar with the FDA system who did not want to be identified said it can handle about 500 concurrent users. In some cases, brokers will spend considerable time filling out the online forms only to get an error message and lose all their inputs when they are kicked off the system, Peterson said.
Customs now has a contingency plan in place to handle that type of situation. “We have actually resorted in some circumstances to receiving paper copies of prior notices and we’re going to clear them manually in some ports if things are not working,” she said.
Even when the FDA’s Prior Notice System Interface is working properly it still normally takes about 25 minutes for someone to enter a line of data into the system, Sauceda acknowledged. If a broker has an entry of 30 items, which is average for an agricultural entry, it can take hours to key in the data, she said. Peterson said a customs entry can easily include four or five prior notices for different kinds of products and take one to two hours to complete.
Customs officials said they considered directors in each port as their de facto ombudsmen for resolving industry complaints on Customs matters. Ahern cautioned that an ombudsman could undercut some of the processes the agency has in place if the job is not carefully structured.
The comment period for the prior notice and facility registration requirements will be open for another 30 days once a notice is published as expected in the Federal Register this week, said Sauceda.