FDA Remains Undaunted By Lagging Compliance

The FDA plans to step up educational efforts to combat failure by companies to comply with Bioterrorism regulations

Last October 10, the U.S. Food & Drug Administration (FDA), in conjunction with the U.S. Bureau of Customs & Border Protection (CBP), instituted new rules requiring registration of all food facilities and advance notification of imported food shipments prior to arrival in the U.S. But, to date the FDA estimates that as many as 220,000 facilities have yet to register.

The two interim final rules carry out provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and officially took effect on December 12, 2003.

The FDA had anticipated the registration of about 420,000 domestic and foreign food facilities that manufacture, pack or hold food for human or animal consumption. By mid-April, only 104,000 foreign facilities and 96,000 domestic facilities had registered.

Officials from the FDA site confusion or lack of awareness as a possible reason for lagging numbers. They don't feel that companies are intentionally trying to skirt the law. For example, small companies that do not typically ship interstate are more likely to be unaware of their responsibilities, as they do not have everyday communication with the FDA.

"We feel that some companies either hadn't heard about the regulations, didn't think they were applicable, or couldn't figure out how to comply," an FDA spokesman said.

The FDA may discover that companies haven't registered when imports arrive in the U.S. because "prior notice" forms require registration numbers. A facility's failure to register also may be discovered during the course of a routine FDA inspection.

The FDA's response to violations until August 12, 2004 (eight months after the mandatory deadline) will be mainly to step up education regarding the regulations.

"The FDA is putting more of an emphasis on education throughout the industry, rather than on fining those companies who haven't complied," the spokesman said.

This will be accomplished through actions such as the distribution of flyers at points of import, providing updated information on the FDA website, providing notice of violation to companies that fail to comply, and continuing to track compliance data in order to best determine how to further educate the industry.

Although education is its first option, the FDA is not without the power to assess fines for noncompliance. It is important to remember that failure to register is a violation of the law. The actions taken by the FDA depend on the level of violation that occurs and the time period in which it occurs (see accompanying table). Companies who repeatedly ignore violations and warning letters are particularly at risk for fines.

In most cases, correcting violations is a relatively easy process. A facility's owner, operator or agent in charge can register online and receive a registration number nearly instantaneously. Registration can also be done on paper, and mailed to the FDA.

In its continuing effort to work with the food industry to meet the requirements of advance notice and facility registration, the FDA reopened the comment period for both regulations. Companies had the opportunity to submit written or electronic comments on specific portions of the facility registration interim final rules from April 14 to May 14, 2004.

"The FDA is particularly interested in receiving comments from companies now that they have had some real world experience with the regulations in place," the FDA spokesman said.


Upcoming Regulations

When the Bioterrorism Act was instituted by President Bush in 2002, it specified that the FDA was to create regulations addressing particular areas of concern. The Prior Notice and Registration of Food Facilities provisions were two such regulations. Two other regulations, Administrative Detention and Record Keeping, are due to be updated this May. The official publishing of the Administrative Detention regulation will elucidate the specific circumstances when the FDA can use its detention powers, and will better define how this is to be accomplished. This regulation is in place to give the FDA the power to detain suspicious or threatening shipments, preventing them from entering interstate commerce, while the FDA obtains the necessary paperwork, court orders, etc. to deal effectively with the shipment in question.

The Record Keeping regulation allows the FDA to access a company's records if it determines that the potential for serious adverse health consequences exist. Its publication this May will further clarify the specifics of the regulation. Officials say both the Administrative Detention and Record Keeping regulations were delayed by the abundance of comments received during their comment period.