The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the "Bioterrorism Act")

Bioterrorism Act Compliance

In 2002, the President of the United States signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the "Bioterrorism Act" or "BTA"). The BTA was a direct response to the terrorist attacks of September 11, 2001 and was intended to provide FDA with new tools to prevent and respond to bioterrorism. It focused primarily, although not exclusively, upon foods.

The BTA expanded FDA's authority with respect to foods through several specific areas of new FDA regulatory and administrative power:

1. Registration of food facilities with FDA (foreign and domestic);
2. Prior notice of virtually all imported food shipments under FDA authority;
3. Record keeping requirements for food facilities (to include transporters of food in the U.S. and international carriers bringing food into the U.S.);
4. FDA administrative detention (not import detention) of food where there is credible evidence that such food presents a threat of serious adverse health consequences or death;
5. Debarment of food importers for various violations related to food importation;
6. Permission to reimport previously refused foods if certain criteria are met

FDA has implemented these four major areas by promulgating four bioterrorism regulations. FDAImports.com consultants and affiliated attorneys regularly provide guidance and representation with respect to all aspects of the BTA, FDA's implementing bioterrorism regulations, the agency's bioterrorism security guidance for food, cosmetic, drugs, and biological products establishments and their respective products.

For instance, FDAImports.com consultants and affiliated attorneys are able to advise clients regarding prior notice of food imports and food facility registration requirements, evaluation of record keeping compliance, responding to FDA requests for records under the agency's BTA record keeping authority, identifying opportunities for clients to protect the confidentiality of biosecurity related information and data, handling FDA or Customs refusals and delays due to BTA enforcement at U.S. Ports of Entry, implementation of FDA's product security and bioterrorism guidance, and integration of biosecurity principles into C-TPAT programs.