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 safe food imports while achieving compliance with the requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).
The goal of the transition policy is to provide complete clarity and education about the new import requirements, to achieve a new level of food security in the United States without disrupting trade. The policy guide deals with the enforcement of two provisions of the Bioterrorism Act which become effective on December 12, 2003: the registration with FDA of domestic and foreign firms that manufacture, process, pack or hold food for consumption in the U.S.; and the requirement that FDA receive a prior notification of all human and animal food, drinks and dietary supplements imported or offered for import to the United States. The latter rule covers also food packages mailed or brought to the U.S. by individuals from abroad, which must be accompanied by a notice with information about its nature and origin.
In October, FDA and CBP jointly published two interim final rules that described how the affected firms can register with FDA electronically, and specified, among others, that the prior notice must be received by the agency between two and eight hours -- depending on the mode of transportation -- before each shipment's arrival at the U.S. border. The two agencies also noted that they intended to provide a transition period during which the hundreds of thousands of foreign food firms, domestic importers, and individuals who wish to mail or bring food packages from abroad can learn how to meet this requirement.
The policy guide issued today makes clear that during the next 8 months, FDA and CBP will rely on educating the affected firms and individuals while gradually phasing in enforcement of the registration and prior notice rules. As always, both agencies will continue to make sure that the imported products are safe for human or animal consumption.
Under the policy guide, generally no food imported from abroad between December 12, 2003 and March 12, 2004 will be refused entry because of lack of compliance with the Bioterrorism registration and prior notice rules, and the two agencies will respond to violations as much as possible by education about the requirements. From March 13, 2004 until May 12, 2004, CBP generally will assess civil monetary penalties to non-compliant firms whose violation of the rules is repetitious, intentional or flagrant. Full compliance will be expected by August 12, 2004.
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. "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 at the U.S. ports of entry have already begun a general campaign to educate food importers, brokers, and transporters, and other affected industry representatives with written material as well as in briefings and seminars on compliance of 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.
· Following the first three months of education and outreach on compliance, FDA and CBP plan to issue penalties against the most egregious violators of the provisions of 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.
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. If FDA decides during and after the transition period to not 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.