In mid-October 2003, the Food and Drug Administration (FDA) plans to publish final regulations necessary to carry out major food safety provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. These regulations will place new responsibilities on many companies and individuals within the food and animal feed industries.
All domestic and foreign facilities that manufacture, process, pack, or hold food for consumption by humans or animals in the United States must register by December 12, 2003, and only after the final rule has been published. An online registration system will be available once FDA publishes the final rule. Registration by mail will also be possible and there is no fee associated with registration.
In addition, FDA must be given prior notice of each article of food imported or offered for import into the United States before the food arrives at the port of entry. This requirement also takes effect December 12. Importers, in most circumstances, will be able to provide the required information to FDA using Custom and Border Protection’s Automated Commercial System, currently used to obtain import information required by Customs.
Also required will be the creation and maintenance of records by domestic persons that manufacture, process, pack, transport, distribute, receive, hold, or import food for consumption in the United States that identify the immediate previous sources and the immediate subsequent recipients of food (i.e., where it came from and where it went). Foreign facilities that manufacture, process, pack, or hold food for consumption in the United States also would have to comply with this requirement. Businesses will have anywhere from six to 18 months following publication of the rule to comply, depending on the number of employees at the company.
In a press release, FDA stated, “It is critically important that all segments of the farm- or sea-to-table food industry continuum, both those who have new responsibilities under the act and those who are exempt, understand what they will – or will not – be required to do.”
Following the terrorist events of September 11, 2001, Congress passed the bioterrorism act to strengthen U.S. security against bioterrorism. The act provides several new tools that enable FDA to act quickly in responding to threatened or actual terrorist attacks on the U.S. food supply or other food-related emergencies by providing the agency with better information than is now available about the production and distribution of food consumed in, or entering, the United States.
To assist those who must comply, FDA has posted the bioterrorism act and the regulatory proposals to implement these provisions on their Web site at www.fda.gov/oc/bioterrorism/bioact.html.
October 2003 Render