FDA Bioterrorism Final Interim Regulations

In accordance with the passage of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), the Food and Drug Administration has issued its final Interim Regulations, which take effect on December 12, 2003. These rules have been issued in an effort to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.

The following is detailed information on the 2 major parts of these regulations. In addition to this information full information, including the full text of these regulations and various additional background information can be found on the FDA website.

1)Registration Of Food Facilities, 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 the FDA. Under this interim final regulation, all affected facilities must register by December 12, 2003. In the event of a potential or actual bioterrorism incident or an outbreak of food-borne illness, facility registration information will help FDA to determine the location and source of the event and permit the agency to notify quickly facilities that may be affected. Facilities can register online via the Internet, by completing a paper form, or submitting to FDA a CD-ROM with relevant registration information. The online registration system will be available for use on October 16, 2003.

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. 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

Food contact substances and pesticides are not "food" for purposes of the interim final rule. Thus, a facility that manufactures/processes, packs, or holds a food contact substance or a pesticide is not required to register with FDA.

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. Registration of foreign facilities requires the designation of a U.S. Agent.

The following facility types are exempt from registration:

Private residences of individuals

Non-bottled water drinking water collection and distribution establishments and


Transport vehicles that hold food only in the usual course of their business as carriers Farms Restaurants Retail food establishments

Nonprofit food establishments

Fishing vessels

Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture

Registration is one time, there is no fee and registration can be done via the Internet, mail or fax.

2) Prior Notice of Imported Food Shipments – which requires that FDA receive prior notice of food imported into the United States. Most of the prior notice information required by the interim final rule is data usually provided by importers or brokers to the Bureau of Customs and Border Protection (CBP) when foods arrive in the United States. Now, the Bioterrorism Act requires that this information also be provided to FDA in advance of an imported food's arrival to the United States. FDA will use this information in advance of the arrival to review, evaluate, and assess the information, and determine whether to inspect the imported food. FDA and CBP have collaborated on the implementation of the prior notice interim final rule. Nearly all of the current imported food shipments can comply by using CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS). Prior notice can be submitted either through the Automated Broker Interface (“ABI” - currently used by Broker) or FDA's Prior Notice (PN) System Interface beginning December 12, 2003. FDA’s system is still in development as are the changes required to the current ABI system to accommodate these changes.

The rules state that any individual with knowledge of the required information, including, but not limited to, brokers, importers, and U.S. agents, may send this prior notice to FDA. Further, prior notice must be received and confirmed electronically by FDA no more than 5 days before arrival and, as specified by the mode of transportation below, no fewer than:

1. 2 hours before arrival by land by road

2. 4 hours before arrival by air or by land by rail

3. 8 hours before arrival by water

4. The time consistent with the timeframe established for the mode of transportation for an article of food carried by or otherwise accompanying an individual if it is subject to prior notice (The food must also be accompanied by the FDA confirmation.)

In addition, prior notice must be received and confirmed electronically by FDA before food is mailed by international mail. (The parcel must be accompanied by confirmation of FDA receipt of prior notice.)

Exclusions to these rules are as follows:

(1)Food carried by or otherwise accompanying an individual arriving in the United States for that individual's personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution);

(2)Food that is exported without leaving the port of arrival until export;

(3)Meat food products, poultry products and egg products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act;

(4)Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States.

Food that is imported or offered for import with inadequate prior notice is subject to refusal and holding at the port or in secure storage.