Following the events of Sept. 11th the US Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). The act was signed into law on June 12, 2002 by President Bush. The Bioterrorism Act is divided into five sections and the FDA is responsible for carrying out certain provisions particularly the Protection of Food Supply and the Protection of Drug Supply.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act or the Act) have directed the Secretary of Health and Human Services to issue final regulations that establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms, restaurants and certain others) who manufacture, process, pack, transport, distribute, receive, hold, or import food. The records that must be kept by these regulations are those that are needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. This regulation implements the recordkeeping authority in the Bioterrorism Act. For a copy of the act please visit the FDA Website.
Who must establish and maintain records?
Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food; foreign persons that transport food in the U.S.; and persons who place food directly in contact with its finished container. For these regulations, the term persons includes individuals, partnerships, corporations, and associations.
How is food defined for purposes of this regulation?
Food is defined by reference to section 201(f) of the Federal Food, Drug, and Cosmetic Act. Section 201(f) which defines food as (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. Examples of food include
- Dietary supplements and dietary ingredients
- Infant formula
- Beverages (including alcoholic beverages and bottled water)
- Fruits and vegetables
- Fish and seafood
- Dairy products and shell eggs
- Raw agricultural commodities for use as food or components of food
- Canned and frozen foods
- Bakery goods, snack food, and candy (including chewing gum)
- Live food animals
- Animal feeds and pet food
What records must be established and maintained by non-transporters of food?
For non-transporters, i.e., persons who own food or who hold, manufacture, process, pack, import, receive, or distribute food for purposes other than transportation, the records have to
- Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including the name of the firm; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety (e.g., Brand X Cheddar Cheese, not just cheese; romaine lettuce, not just lettuce); date received; quantity and type of packaging (e.g., 12 oz. bottles); and identify the immediate transporter previous sources including the name, address, telephone number--and, if available, fax number and e-mail address. Persons who manufacture, process or pack food also must include lot or code number or other identifier if the information exists.
- Identify the immediate non-transporter subsequent recipients of all foods released, including the name of the firm; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety; date released; quantity and type of packaging; and identify the immediate transporter subsequent recipients, including the name, address, telephone number--and, if available, fax number and e-mail address. Persons who manufacture, process or pack food also must include lot or code number or other identifier if the information exists. The records must include information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.
What records must be established and maintained by transporters of food?
The term transporters includes persons who have possession, custody, or control of an article of food in the United States for the sole purpose of transporting the food, whether by road, rail, water, or air. The term transporters also includes foreign persons that transport food in the U.S., regardless of whether the foreign persons have possession, custody, or control of food for the sole purpose of transporting it. For transporters, records have to include names of the transporters immediate previous source and transporters immediate subsequent recipient, origin and destination points, date shipment received and date released, number of packages, description of freight, route of movement during the time the food was transported, and transfer point(s) through which the shipment moved.
For further information on the specific requirements of this final rule, please refer to the final rule itself on the FDA website.
Bioterrorism Act Details
Section 305 Registration
Section 307 Prior Notice
Section 306 Records Maintenance
According to the US Bio-Terrorism Act , all food & beverage companies exporting to the US must have registered with the FDA by December 12th 2003.
As part of its efforts to protect the US nation's food supply against terrorism and other food-related emergencies, the FDA has published two interim final regulations that require:
- a) registration with the FDA of all domestic and foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States and
- b) advance notice to the FDA of any shipment of human or animal food imported or offered for import beginning Dec. 12, 2003.
The Bioterrorism Act makes failure to register a prohibited act. If a foreign facility fails to register and also attempts to import food into the U.S., the Bioterrorism Act requires that the food be held at the port of entry unless FDA or U.S. Customs directs otherwise. All costs involved in the movement of these products will be borne by the operator/agent.
Registrants must register on Form 3537. Registrations can be submitted electronically via the Internet, through surface mail on a paper form or a CD-ROM, or through fax. To register your company with the FDA please visit their website: FDA Registration