A Study On U.S. FDA's New Regulations

U.S. congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 on May 22, 2002. It directed the Secretary of Health and Human Service to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply. It also authorized FDA (the Food and Drug Administration) to carry out the provisions of the Bioterrorism Act. FDA promulgated Registration of Food Facilities Interim Final Rule, which requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA; Prior Notice of Imported Food Shipment Interim Final Rule, which requires exporters, importers or their agents to submit prior notice to FDA or CBP no more than 5 days and no less than 2 hours before food arrives at the port of arrival; Establishment and Maintenance of Record Interim Final Rule, which requires manufacturers, processors, packers, distributors, receivers, holders and importers of food to establish and maintain record with FDA; Administrative Detention of food For Human or Animal Consumption Interim Final Rule, which authorizes FDA to order the detention of food if an officer or a qualified FDA employee finds credible evidence or information indicating the food presents a threat of serious adverse health consequences or death to humans or animals.FDA's new regulations involve a great many enterprises, complicated formalities, and stern punishments. It will influence international food trade greatly. This thesis, which embraces five parts, does a good research on them.Part I introduces the structure of FDA and the basic contents of FDA's new regulations.Part II analyses the reasons that U.S. is attacked by international terrorists. It clarifies that FDA's new regulations can't make the U.S. "antiterrorism" dream come true under economic globalization, pointing out that antiterrorism is not the real purpose of the new regulations.