New US bioterrorism legislation

In response to the terrorist attacks on the US in September 2001, the US Congress last year passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act).

As of 12 December all food facilities exporting to the US will have to be registered with the American Food and Drug Administration (FDA). They will also have to give prior advice of shipments heading to American ports.

Failure either to register or provide advance information on shipments will mean that goods are held at the port of entry and the FDA can order that these be held in a secure facility at the cost of the exporter, importer or consignee.

This new regulation pertains only to facilities that manufacture/process, pack, or hold food, as defined in the regulation, for consumption in the U.S.

A major aim of the legislation is to give America's Food and Drug Administration (FDA) the power to assemble much more comprehensive information on food that is about to enter the country and the companies involved in supplying it.

This will give the FDA better information on which to base decisions to check import consignments, as well as being able to quickly warn the relevant industry sector of food scares, ranging from food-borne illnesses to suspected terrorist activity. Food problems will also be able to be tracked back to their source much more easily.

Registration information

Basic registration information required will include the company name, full address, phone and fax, including home phone numbers, e-mail address, details of parent or subsidiary companies where relevant and US agent contact information. Additional information will include type of activity, type of storage used, seasonality of product where applicable and warehouse details.

Type of Food

Food has been given a broad definition and includes the finished product as well as ingredients and additives.

Product categories exempt are meat, poultry and processed eggs, as those are the responsibility of the United States Department of Agriculture.

What types of facilities do not have to register?

• Private residences of individuals, even though food may be manufactured/processed, packed, or held there.
• Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems.
• Transport vehicles that hold food only in the usual course of their business as carriers.
• Farms, i.e., facilities in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.
• Restaurants, i.e., facilities that prepare and sell food directly to consumers for immediate consumption, including pet shelters, kennels, and veterinary facilities that provide food directly to animals.
• Retail food establishments, such as groceries, delis, and roadside stands, that sell food directly to consumers as their primary function, meaning that annual sales directly to consumers are of greater dollar value than annual sales to other buyers.
• Non-profit food establishments, which are charitable entities and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S.
• Fishing vessels that harvest and transport fish. Such vessels may engage in practices such as heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel and remain exempt.
• Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture, that is, facilities handling only meat, poultry or egg products.

Registration

The owner, operator, or agent in charge of a domestic or foreign facility that manufactures/processes, packs, or holds food for human or animal consumption in the U.S., or an individual authorized by one of them, must register that facility with FDA by December 12, 2003. A domestic facility must register whether or not food from the facility enters interstate commerce. A foreign facility must designate a U.S. agent (for example a facility's importer or broker), who must live or maintain a place of business in the U.S. and be physically present in the U.S., for purposes of registration.

Registration is required only once for each food facility. However, required registration information must be updated if it changes. There is no fee for registration or for updates of any registration.

Failure of a domestic or foreign facility to register, update required elements, or cancel its registration in accordance with this regulation is a prohibited act under the Federal Food, Drug, and Cosmetic Act. The Federal government can bring a civil action to ask a Federal court to enjoin persons who commit a prohibited act, or it can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act.

Detention of food shipments

If a foreign facility is required to register but fails to do so, food from that foreign facility that is offered for import into the U.S. is subject to being held within the port of entry for the article unless otherwise directed by FDA or the Bureau of Customs and Border Protection (CBP).

The FDA are now also authorised to order the detention of food if an officer or qualified FDA employee finds, during an inspection, examination, or investigation, credible evidence or information indicating the article presents a threat of serious adverse health consequences or death to humans or animals.

Prior Notice

Exporters or their US agents will need to advise expected arrival of product. Further information is provided at http://www.cfsan.fda.gov/~dms/fsbtac13.html

Information required will include type of product and quantity, country of origin, FDA product code characters, lot and production code, customs code, manufacturer and shipper, grower if known, importer, owner and consignee, port of entry and carrier. FDA will issue a confirmation of prior notice to the transmitter upon successful receipt of the prior notice information.

Record-keeping

Businesses manufacturing, processing, packing, transporting, distributing, receiving, holding or importing food will be required to create and maintain records that the FDA deems necessary to track food sources and the immediate subsequent recipients.

Comment

This will involve extra paperwork and so costs for exporters to the US. A US agent, if not already used, must be obtained. Extra consideration should be given to ensure that all agents and contractors are aware of the requirements. Insurance and other contracts should allocate the extra risks accordingly.

For further information please contact Mark Tyler at [email protected] or Jessica Burt at [email protected]