U.S. Customs: Implementation of FDA bioterror rules goes smoothly

U.S. Customs: Implementation of FDA bioterror rules goes smoothly    Food shipments did not come to a halt at U.S. ports after authorities this month ratcheted up enforcement of new bioterrorism rules as many feared, said Cathy Sauceda, director of special enforcement for U.S. Customs and Border Protection.
   Strong compliance by importers with requirements for submitting prior notice of incoming food products meant that international trade kept flowing without interruption despite the phase in of penalties by Customs and the Food and Drug Administration, Sauceda told a key Customs advisory group on Friday.
   The agencies are taking a graduated approach to implementing rules for prior notice and registration of food facilities. Congress mandated FDA collect the information to analyze the risk of shipments before arrival as part of an effort to protect the food supply from tampering by terrorists.
   The first stages focused on educating companies about the requirements and sending out reminder notices for inaccurate and late prior notices or importation from an unregistered overseas facility. In the third phase, Customs can issue civil penalties for repeat and intentional offenders. Full enforcement, including refusing to admit shipments for technical violations, goes into effect Aug. 13. The government can turn away shipments that are determined to be dangerous at any time.
   Since the start of the third phase of enforcement June 4 there have only been 830 failed entries through the Automated Broker Interface, 591 non-compliant entries filed through FDA’s Web-based system and 131 failed in-bond entries, Sauceda told the industry panel. Most entries were accepted once corrections were made.
   Only 96 shipments were returned to a foreign country and two shipments were abandoned, she said.
   Importers and their agents are filing more than 20,000 prior notices per day through the existing ABI system for transmitting entry data to Customs. The remaining 20 percent of food entries are filed through FDA’s Web-based Prior Notice System Interface.
   “The ABI filers and even the mom-and-pop PNSI filers knew what to do,” Sauceda said. That’s a big change from even a couple of months ago, when FDA reported that more than 50 percent of entries had incomplete prior notice data.
   Companies that are unable to transmit notices on time due to FDA and Customs computer glitches will not be penalized, said Joe McCallion, deputy director, FDA division of import operations and policy. FDA was roundly criticized by COAC members for failing to send a representative to the previous meeting in April.
   Customs is conducting a thorough analysis of why companies are still failing to comply and continuing counseling in preparation for the Aug. 13 enforcement deadline, Sauceda said. The agency published on its Web site Friday guidelines for different degrees of penalties and mitigating factors.
   McCallion said the FDA is working to solve some problems with PNSI, such as broken links with ABI, slow access or error messages that result in the loss of data already input to the system. He urged commercial shippers to file prior notice through the Automated Broker Interface of Customs' trade data system.
   “PNSI was intended for entries that do not normally go through ABI and (the Automated Commercial System). It was set up as an accommodation to small filers and individuals,” McCallion said. As a Web-based system, PNSI depends on Internet service providers and other factors outside FDA’s control, whereas ACS offers a direct electronic pipe to Customs and FDA.
   Importers also worry that PNSI cannot handle the volume of commercial transmissions in situations when ACS goes down.
   Arthur Litman of FedEx Trade Networks asked FDA to suspend the penalty requirements until it fixes all of its automation problems.
   “There is nothing that puts terror in my heart like this program,” he said.
   McCallion said delaying implementation is not a legal option, but acknowledged that the agency must quickly come up with better contingency plans. Customs has said its contingency plan was to resort to accepting paper copies of prior notices and clearing food entries manually at some ports.
   The trade community needs to be informed within minutes about system outages and possible alternatives, Litman suggested.