Recent U.S. Food and Drug Administration (“FDA”) regulations released under The Public Health Security and Preparedness and Response Act of 2002 (the “Act”) have imposed new compliance obligations that affect companies that export food into the United States. With the addition of Act Section 305, which became operative for most businesses in mid-2004, most foreign facilities that produce, manufacture or process food that will be consumed in the United States are obligated to register with the FDA.

This registration with the FDA must contain information necessary to notify the FDA Secretary (“Secretary”) of the name and address of each facility at which, and all trade names under which, the registrant conducts business and, when determined necessary by the Secretary through guidance, the general food category that is handled/produced by the facility. The new regulations require that any food originating from an unregistered source be detained at the border until the facility is registered.

Act Section 306 Amends Chapter IV to authorize the Secretary to have access to certain records when there is a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. This rule applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of the food.  There is an exclusion for farms and restaurants.  This rule has an exception for information such as recipes, financial data, personnel data, research data, and sales data (other than shipment data regarding sales).

Act Section 307 Amends Section 801 to require prior notice of imported food shipments. The notice is required to describe the article of food being exported, the manufacturer and shipper, the grower (if known within the specified time in which notice is required), the country of origin, the country from which the article is shipped, and the anticipated port of entry.  The section further states that if notice is not provided, the article shall be refused admission.  Furthermore, under this section, the regulation provides a specific (narrow) time period in which companies that are sending food across the border are required to notify the FDA of such shipments.