Globalization & FDA Bioterrorism Safeguard Measures

In June 2002, the President enacted the Public Health Security and Bioterrorism Preparedness and Response Act (the Act) in an effort to improve the health system’s ability to respond to a terrorist act. This bioterrorism safeguarding measure requires that FDA protect our food supply by imposing strict safety regulations on food supply firms. Over 400,000 foreign and domestic food suppliers will be required to register their commodities with the FDA.

The FDA came out with four proposed rules in response to the Act. In short, these include 1) Registration, 2) Records maintenance, 3) Prenotification of arriving shipments and 4) Agency authorization to detain those shipments that pose a threat to public health or safety.

Food facilities must be registered with the FDA by December 12, 2003. The Agency has not yet issued required registration information as of this writing however, a firm must register regardless of where the FDA is in this process and a proposed form is available for view on the FDA’s website. Records required for maintenance on each food include: person responsible for the food at the firm including his address, telephone numbers and email (if applicable), food type and brand, received date, released date, lot or identification number, amount, packaging material, and name, address, telephone numbers, and email of the transporting party.

Firms must notify the Agency prior to shipping their goods into the U.S. This notification must include the food type, who manufactured it, who shipped it and from where and who grew it and where. This prior notification must be conducted within 5 or more days of shipment.

The Agency may detain food articles that are suspected to pose a threat to the public health or safety. This detention period ranges from a few hours to less than 30 days depending on the commodity and its perishable likeliness.

The Agency is currently receiving comments on the records and detention proposals. Firms are urged to visit the FDA website, www.fda.gov/oc/bioterrorism/bioact.html, for continuous updates on these regulations.