Date: Sep 30, 2005
In the wake of the 9/11 terrorist attacks, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In order facilitate a governmental response to a real or threatened terrorist attack on the U.S. food supply, among other things, the law requires that all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. register with the Federal Food and Drug Administration. On October 3, FDA will publish its final regulations implementing this provision of the law, which are consistent with the interim final rules issued two years ago. Those rules required registration by December 12, 2003.
A key provision of the rules requires that all foreign facilities designate a U.S. agent to serve as the primary point of contact, should the government need to communicate with the foreign facility. According to the rules, contact with the U.S. agent is deemed to be contact with the foreign facility. Because many such foreign facilities are small operations that do not have U.S. offices, affiliates, or agents, several food-related trade associations with an international membership have stepped forward to serve as U.S. agents for their foreign members. Clearly, this can be an invaluable service for the association to provide to its foreign members, because it puts in place a communications link that is now key to doing business in this country. Just as important in an age of tight association budgets, by offering this service to their members, some trade associations are able to open up a new and potentially substantial revenue source. Of course, there are legal obligations imposed on the agent, which must be fully understood before embarking on such a relationship.