FDA bioterror rules implementation goes smoothly, awaits August test
U.S. government officials say efforts to educate importers about meeting requirements to protect the nation’s food supply from bioterror contamination has paid off so far as companies are providing data in a timely fashion to meet a new legislative mandate, but businesses continue to worry about the impact of a tougher enforcement regime due to start in seven weeks.
Requirements that importers give prior notice of incoming food shipments and that food processing facilities around the world doing business with the United States register with the Food and Drug Administration went into effect in mid-December. On June 4, Customs and Border Protection and FDA initiated a third compliance phase leading up to full enforcement and penalty administration on Aug. 13.
“We have not had long backups at the border,” FDA Acting Commissioner Lester Crawford told the House Energy and Commerce subcommittee on health Friday.
But importers, distributors, grocers, restaurants and other businesses that rely on food products from foreign sources say the potential remains for delays, inconsistent enforcement and confusion at ports of entry to increase once shipments can be held up even for technical violations.
“We do not believe that anyone can confidently predict what will happen when full enforcement begins,” Susan Stout, vice president federal affairs for the Grocery Manufacturers of America, said in prepared testimony.
Since June 4, Customs and FDA have recorded 2,479 shipments that violated the prior notice requirement, a relatively small number of the total agricultural entries into the country, said Cathy Sauceda, Customs' director of special enforcement. Since December, FDA has received 4 million prior notices or about 150,000 notifications of imported food per week, according to Crawford.
A week earlier at the Advisory Committee on Commercial Operations (COAC) of the Bureau of Customs and Border Protection, Sauceda cited 1,421 food shipments that were not filed on time or had inaccurate information.
The agency’s outreach program to the trade community has included presentations to government agencies and trade associations in Europe, Asia and South America as well U.S. trade groups like the Pacific Coast Counsel of Customs Brokers and Freight Forwarders and the National Customs Brokers and Freight Forwarders Association of America (NCBFAA), she said.
But Stout said, “FDA has provided little if any feedback on deficiencies in specific notices. Companies can only guess what problems might have occurred” to cause the FDA to reject a prior notice. The sentiment was echoed by customs broker Roger Clarke, who said that FDA has explained the basic structure of the prior notice system but not provided practical answers to about how the system applies to daily import operations.
Sauceda said at the June 19 COAC meeting that most entries are accepted once corrections are made.
Food and import officials applauded FDA for adjusting the rules to minimize the burden on food companies, but said several key areas still must be improved. Trade associations representing customs brokers argued that full enforcement should be postponed until FDA and Customs can make programming changes to the FDA’s Web-based prior notice filing system and food importers can adjust to these changes.
The best way to reduce the burden on importers would be for Congress and the two agencies to change the law to allow notice of food importation to be submitted prior to the release of the cargo instead of prior to arrival of the cargo in the United States, said Clarke, who heads Los Angeles-based Williams and Clarke Co. Clarke spoke on behalf of the Pacific Coast Council, NCBFAA, the Agriculture Ocean Transportation Coalition, the Coalition of New England Companies for Trade and the New England Seafood Producers Association.
Such a mechanism would still allow food imports to enter the country once an unavoidable error that results in a failure to transmit prior notice, such as glitches in the FDA or Customs' computer systems, has been cleared up and the prior notice requirements have been met.
“We believe this system would be significantly more effective, since it would assure that FDA and CBP do not waste valuable resources on enforcement actions against legitimate food imports that pose no threat to the public,” Clarke said.
The majority of prior notice submissions are filed by brokers through the Automated Broker Interface of Customs' data collection system, but FDA needs to strengthen its Prior Notice System Interface because it cannot handle commercial volumes when the Customs' computer system is down, Clarke said.
He expressed satisfaction with a recently unveiled program that will allow companies to submit standalone prior notices through ABI without having to file a Customs entry, but called on FDA to delay enforcement until the system is fully operational.
“I think I can speak for the entire food import community when I say we want to be in compliance, and we don’t want our cargo sitting on the docks, or in a General Order warehouse because what we though was a proper prior notice filing turned out to be incorrect or inadequate,” Clarke testified. He urged FDA to postpone the final enforcement phase until 60 to 90 days after FDA finalizes fixes to the Prior Notice System.
Although the FDA has reduced the time frames for how far in advance a prior notice must be submitted for different transportation modes, industry officials said they wanted the agency to speed up plans to harmonize those time frames with Customs' shorter requirements for advance transmission of shipping data so that food imports will not be delayed at the border.
“Congress should amend the act to eliminate the requirement that prior notice be submitted no earlier than five days before arrival in the United States. We cannot fathom the reasoning behind such a requirement. After all, CBP is screening cargo data 24 hours prior to vessel loading at the foreign port,” Clarke told the panel.
The groups expressed concern with the FDA’s recent penalty guide, which says that local ports will determine penalties. Clarke said FDA headquarters should determine the penalties to avoid “port shopping.” The groups he represents also disagreed with FDA’s decision to penalize both the submitter and the transmitter for an untimely filing.
The Grocery Manufacturers of America and the National Food Processors Association called on FDA to change the current rules requiring all prior notices to contain the registration number of the facility where the food was produced, saying this posed a particular problem for imports of product samples. Companies import samples to analyze products they may want to order or produce, or to monitor their suppliers and competitors. The registration number is not mandated by the bioterror statute, but FDA created the rule to help manage the new data it collects and one member of the subcommittee suggested that Congress may consider making the use of registration numbers a statutory requirement.
Access to the registration number is not available for a competitor’s food product or if the sample is from a company not doing business already in the United States, Stout said. Industry officials warned that unless the rule is modified, food companies might move their product analysis facilities outside the United States to avoid administrative expenses and retain the ability to test samples for which a registration number cannot be obtained.
“This places U.S. companies at a competitive disadvantage and encourages the relocation of research and development activities to Canada, for example, where import of samples is not restricted,” John Cady, president of the National Food Processors Association, testified.
“The routine importation of small quantities of food product samples simply does not present major food security issues,” Stout said. “FDA should develop a category for which a registration number is not required such as sample products that will not be consumed by the general public or that are not intended for retail sale.”
Food processing and distribution groups also expressed concern about requirements to keep records identifying sources of ingredients and customers that received each product lot. The groups said it is not possible in many instances to keep track of the exact lot codes of products that go to individual stores and that it would cost millions of dollars in information technology upgrades to keep lot level information. They urged FDA to abandon the requirement when it publishes its interim final rule on the subject because inventory records are not based on lot codes and would not help remove products from the market in the event of a safety recall.
“In many cases, a requirement to record lot numbers would mean that distributors must break open pallets and cases and search for the lot numbers to record,” said David French, senior vice president of government relations for the International Foodservice Distributors Association.
Industry compliance with FDA’s rule to register foreign and domestic food facilities has not been as good as the with the Prior Notice requirement. Crawford reported that 208,277 facilities, including 109,381 foreign ones, have registered since December. But that figure is only half of the 400,000 facilities FDA estimated play a role in the U.S. food chain. Crawford said FDA will continue its education efforts about the registration requirement, but also allowed that FDA may have overestimated the number of facilities affected by the law.
Cady requested that FDA provide more guidance about what facilities do not need to register and Crawford said as the agency gathers more experience implementing the rule it may determine additional industry niches to exempt from the requirement.
Rep. John Shimkus, R-Ill., expressed concern that smaller companies are at risk of being squeezed out of business by the spate of new security mandates, including the Bioterrorism Act, because they can’t keep up with all the requirements the same way big companies can allocate administrative and legal resources. Shimkus was one of the original co-sponsors of the law.
“The more government we have to intervene to protect (the nation) the bigger the organizations have to be to comply,” he said.
In response to lawmakers’ questions, Crawford said FDA inspects about 2 percent of all food shipments, including 12,000 inspections in fiscal 2003.
The Association of Food and Drug Officials, representing state and local government food safety officials, testified that the FDA needs to take the additional measure of performing inspections at foreign manufacturing sites rather than at domestic ports of entry in order to better detect, detain and remove intentionally adulterated foods from commerce.
Crawford said his agency is considering a new rulemaking to implement part of the bioterror law that requires food that has been refused for safety reasons to be marked so importers can’t try to enter the shipment at another port.
