Phased enforcement of FDA rules has pluses and minuses
The U.S. Bureau of Customs and Border Protection and the Food and Drug Administration are tweaking their guidelines for complying with the food import requirements of the Bioterrorism Act even as enforcement deadlines approach, leaving importers with the challenge of trying to comply with a moving playing field.
During Friday’s meeting of the Advisory Committee on Commercial Operations, a Customs official reiterated the agency’s timetable for enforcing the prior notice and food facility registration requirements of the act, which went into effect in December.
The decision to phase in enforcement follows the approach the agency used in implementing the 24-hour rule for advance manifest filing of ocean manifests. During the first phase, currently scheduled to end March 12, the agency is taking an educational role, contacting companies that fail to file a prior notice, or do so in an untimely or incomplete way, and counseling them how to avoid compliance mistakes, said Cathy Sauceda, director of special enforcement. The only shipments that will be held are ones that pose a clear bioterrorism threat. At least 50 percent of prior notices filed so far have been incomplete, inaccurate or late, she said.
The second phase enforcement is set to begin March 13 and continue until May 12, at which time “egregious violations” will be subject to civil monetary penalties, Sauceda said. The third phase, from May 13 to Aug. 12, ratchets up enforcement another notch. Customs will begin holding shipments for failure to provide prior notice, and continue to issue fines for those that have problems properly filing their forms.
Aug. 13 is the date when full-scale enforcement activity will begin. On that date, shipments will be held at the port of entry even if the violation is simply procedural.
“Everything will be held unless there is some reason for why (prior notice) is not happening, like maybe trucks are backed up to Mexico City,” Sauceda said, making it clear that it would take a very unusual circumstance for Customs to back off and use discretion.
Customs and the FDA continue to work on harmonizing the time frames for prior notice in an effort to more closely mirror Customs’ rules that allow shorter time frames for filing manifests prior to arrival at the border for air, rail and truck shipments. Sauceda said the agencies would publish the final time frames by March 15.
But uncertainty about the filing deadlines warrants a further enforcement extension because companies are finding it difficult to set their computer systems to automatically send notices when they don’t have information on the dates and times necessary for compliance, said Carol Fuchs, a lawyer at KMZ Rosenman. It is difficult for the trade community to comply when the guidelines for enforcement are changing at the same time the government is moving ahead with enforcement, she added.
“These processes are working concurrently,” Fuchs said. “But to say over the next month or two or three you are gong to put up guidance in certain areas and during that same time people should be gearing up their systems so they can comply, it is very difficult. So in that context the time frames (for enforcement) might still be a bit aggressive.”
So far, shipments that have been held have met both agencies criteria for closer inspection, due to anomalies in shipping data that raise suspicion about their origin or integrity. Shipments are not being singled out solely on the basis of FDA targeting rules, Sauceda said.
Customs has recognized some implementation mistakes and is working to correct them, she said. One involves a lockout feature on the Automated Broker Interface that prevents an importer from changing an entry once prior notice has been filed. Customs is working with FDA to develop a list of items that can be changed after the fact so that goods are not held up, Sauceda said.
Another fix already in place is eliminating the need to file prior notice for U.S. exports that are being returned, she said.
“The phase in period has been good for you (in the trade community) and good for us,” Sauceda told COAC.
John Peterson, from broker C.H. Powell, complained about the fact that the rules do not allow an importer to file prior notice more than five days in advance of a shipment’s arrival, preventing companies from clearing up data problems and other issues in advance. Stuart Verdery, an official with the Department of Homeland Security, asked Peterson to submit a detailed description of the problem for further review.