February 24, 2000

On July 3, 1999, the President announced an initiative to ensure the safety of imported food by directing the Secretaries of the U.S. Department of Health and Human Services and the U.S. Department of Treasury to develop new operational procedures to protect the public health. This initiative is geared to optimize the statutory authorities and resources available to FDA and the U.S. Customs Service to take whatever steps are feasible to protect consumers from unsafe imported foods. The President directed the agencies to target unscrupulous importers who violate the rules and work to subvert the system by moving unsafe foods into U.S. markets.

On December 11, 1999, the Secretaries of Health and Human Services and Treasury submitted the "Presidential Initiative - Safety of Imported Foods, Status Report" to the President. The report presented the progress made in each area and a plan for fully accomplishing the President's directive. A copy of the report is available on the World Wide Web at http://www.foodsafety.gov.

On February 10, 2000 in Irvine California and on February 17, 2000 in Washington, D.C., FDA and the U.S. Customs Service hosted public meetings to discuss the six specific objectives in the President's directive and to review of the new operational procedures proposed to accomplish each of the six objectives with stakeholders and other interested parties.

Participants in the public meetings actively expressed opinions and concerns about the report and action plan, and to work through the issues and develop options. All were anxious to be kept informed of the progress of the plan and the resulting procedures and rules. They were concerned that the procedures be transparent and timely. Generally, participants recommended that the agencies: 1) assure equal treatment of domestic and imported foods; 2) recognize the economic impact of the procedures and proposed rules; 3) assure the promptness of decisions, particularly those requiring destruction or marking; and, 4) anticipate the impact of equivalency.

Some specific concerns and options suggested were: 1) provide alternatives to bonded warehouses for secured storage; 2) target the destruction procedure toward those intending to import a "bad" product, rather than those simply importing an unsafe food; 3) assure that the "refusal" mark specifies the reason for refusal; 4) reduce audits of private labs based on accreditation; and, 5) limit the imposition of increased bond to importers subject to secured storage.

In keeping with the President's Directive to target unscrupulous importers, Customs is in the process of reviewing comments and finalizing the rule concerning increased bonds and FDA is in the process of developing proposed rules covering marking and private laboratories. Both will be published for comment in the Federal Register. Both agencies are in the process of finalizing procedures to deal with secured storage, destruction, and civil monetary penalties.

Food Safety Initiative Staff E-mail: cah@vm.cfsan.fda.gov

Office Number: (202) 260-8920 · FAX (202) 260-9653 CFSAN Web site: http://www.cfsan.fda.gov/