November - December 2003
Food Safety Regulations Issued
Health & Human Services Secretary Tommy Thompson announced in October the issuance of two Food and Drug Administration (FDA) regulations that will bolster the safety and security of America's food supply. The new regulations will enable better targeted efforts to monitor and inspect imported foods and will allow quick identification and notification of food processors and other establishments involved in any deliberate or accidental contamination of food. "By requiring advance notice for imported food shipments and registering domestic and foreign food facilities, we are providing critical new tools for the FDA to identify potentially dangerous foods and better keep our food supply safe and secure," Secretary Thompson said. "These new requirements represent the latest steps in our ongoing efforts to respond to new threats and improve the safety of all the foods that we eat in this country."
The two new regulations will implement key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which provided FDA new authority to protect the nation's food supply against actual or threatened terrorist acts and other food-related emergencies. "With input from the private sector, our partners in the federal government and the governments of our trading partners, we will use these regulations to work more effectively than ever to protect America's food supply, while maintaining the regular, free flow of commerce that is so vital to the well being of our citizens," said FDA Commissioner Mark B. McClellan, M.D., Ph.D.
The first regulation requires food importers to provide the FDA with advance notice of human and animal food shipments imported or offered for import on or after December 12, 2003. This will allow FDA to know, in advance, when specific food shipments will be arriving at U.S. ports of entry and what those shipments will contain. This advance information will allow the FDA, working with U.S. Customs and Border Protection, to more effectively target inspections and ensure the safety of imported foods. The FDA expects to receive about 25,000 notifications about incoming shipments each day.
The second regulation requires domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the agency by December 12, 2003. As a result, FDA will have for the first time a complete roster of foreign and domestic food facilities. The requirements will enable the FDA to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food. The FDA expects about 420,000 facilities to register under this requirement.
Under the new regulations, prior notice of imported foods must be received and confirmed electronically by FDA no more than five days before its arrival and no fewer than: two hours before arrival by land via road; four hours before arrival by air or by land via rail; or eight hours before arrival by water. In addition, for international mail shipments, notifications must be made before the shipment is mailed. Also, when an individual carries or otherwise transports foods subject to the new requirement, advance notice of two, four or eight hours is required - depending on the mode of transportation. The food must also be accompanied by confirmation of receipt for FDA review.
The advance notice to the FDA may be submitted electronically in most circumstances using Customs' existing ABI/ACS system, making it easier for importers to comply with the new law. In addition, the FDA will operate a new Prior Notice System Interface that can receive such notifications. The second regulation requires the owner, operator, or agent in charge of a domestic or foreign food facility to register with FDA, providing information about the name and address of each facility at which, and all trade names under which, the registrant conducts business, and information about certain categories of food the facility produces. For a foreign facility, the registration must include the name of the U.S. agent for the facility.
Registration is required for domestic facilities whether or not food from the facility enters interstate commerce. Domestic facilities are also required to provide emergency contact information. All changes to such information must be reported within 60 days.
Except for specific exemptions, the registration requirements apply to all facilities that manufacture, process, pack or hold food regulated by FDA, including animal feed, dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives.
Registration would not be required for private residences of individuals; certain food transport vehicles; facilities that manufacture food contact substances and pesticides; farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; non-processing fishing vessels; and facilities (such as meat and poultry slaughterhouses) that are regulated exclusively by the U.S. Department of Agriculture. Also exempt are foreign facilities if the food from the facility is to undergo further processing or packaging by another facility before it is exported to the U.S. The regulations are available at: http://www.cfsan.fda.gov/. (HHS News Release, 10/9/03).
