FDA and CBP Announce Their Transitional Compliance Policy
on Food Imports Under the Bioterrorism Act
This press release replaces an earlier version.
FOR IMMEDIATE RELEASE
December 11, 2003
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The United States Food and Drug Administration (FDA) and the U.S. Bureau of Customs and Border Protection (CBP) today issued a compliance policy guide that describes their strategy for maintaining an uninterrupted flow of food imports while improving their safety in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).
The policy guide deals with the enforcement of the Bioterrorism Act's requirement, which becomes effective on December 12, 2003, that FDA receive a prior notification of all human and animal food, drinks and dietary supplements imported or offered for import to the U.S. Another requirement of the Bioterrorism Act mandates that all facilities that manufacture, process, pack or hold food for consumption in the U.S. be registered with FDA. This registration requirement for foreign facilities will be primarily enforced through the prior notice provision.
In October, FDA and CBP jointly published an interim final rule that specified that, among other requirements, the prior notice must be received by FDA between two and eight hours -- depending on the mode of transportation -- before each shipment's arrival at the U.S. border. The prior notice interim final rule also covers food packages mailed or brought to the U.S. by individuals from abroad.
As the rule becomes effective, FDA and CBP expect a "good faith" effort at compliance. The policy guide issued today makes
clear that during the next 8 months, the two agencies will primarily rely on educating the affected firms and individuals. During this period, the agencies will utilize communication and education initiatives, escalating imposition of civil monetary penalities, and ultimately refusal of shipments. This phase-in period will end on August 12, 2004. As always, both agencies will continue to ensure that imported products are safe for human or animal consumption. Regarding food mailed, brought or accompanied to the U.S. by individuals for non-personal use, FDA and CBP generally will continue their education efforts and will not refuse its admission before August 12, 2004 because of inadequate or lacking prior notice.
"Our intention all along has been to implement the Bioterrorism Act in a way that would protect consumers without obstructing the food imports, on which we depend for 20 percent of all fresh produce and up to 60 percent of all the seafood consumed in the U.S.," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "The goal of the transition policy is to provide complete clarity and education about the new import requirements, and achieve a higher level of U.S. food security without disrupting trade. I am satisfied that this policy guide presents a realistic strategy for facilitating the flow of this essential commerce, as well as holiday food packages, while countering the threat of terrorism."
U.S. Customs and Border Protection Commissioner Robert C. Bonner said, "We at the CBP for decades have worked closely with the FDA in ensuring the safety and security of imported foods, especially perishables, that reach our dinner tables every day. The Bioterrorism Act provides us with yet another highly effective tool to safeguard America's food supply from the terrorist threat."
FDA and CBP personnel have already begun an extensive campaign to educate with written material, briefings, and seminars other government officials, domestic and foreign food importers, brokers, transporters, and other affected industry representatives on compliance with the Bioterrorism Act. In addition, during the 8-month transitional period, the two agencies plan to take the following steps:
Gather data to track compliance with the prior notice requirements and to determine how to best use FDA's and CBP's resources to educate industry and the public to achieve full compliance with the Bioterrorism Act.
Provide industry and the public with summary information about the level of compliance with the prior notice rules, including data on the types of errors in submitted prior notices.
Post the summary information on FDA's website at www.fda.gov.
Use the data and summary information to assist the industry and the public in improving the submission of prior notice.
During the phase-in period, FDA and CBP will generally use civil monetary penalties and refusals only in response to repetitive, flagrant and other serious violations.
The policy guide clarifies, however, that FDA and CBP will continue their surveillance of food imports to ensure they are safe, wholesome, and that they comply with other U.S. requirements. The transitional policy announced today does not affect FDA’s or CBP's ability to initiate other actions to protect U.S. consumers. If FDA decides during and after the transition period not to refuse an imported article of food under the provisions of the Bioterrorism Act, such decision will have no bearing on whether the article is admissible on other grounds.
Thus, for food that is imported or offered for imports, FDA will continue to carry out such routine food safety- and security-focused reviews, investigations, and enforcement actions as may be necessary. From December 12, 2003 on, the enforcement of the Bioterrorism Act will be carried out, on a round-the-clock, 7 days a week basis, by hundreds of FDA and CBP employees.
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