October 23, 2003

Bronson reminds Florida agribusinesses of new FDA bioterrorism registration regulations; deadline to register is December 12, 2003

TALLAHASSEE -- Florida Agriculture Commissioner Charles H. Bronson is reminding the state’s agriculture industries of new federal bioterrorism regulations that require some agribusinesses to register their facilities with the U.S. Food and Drug Administration (FDA).

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 directs the federal government to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply.  Accordingly, regulations have been enacted which require facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with the FDA 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 quickly notify facilities that might be affected.

“I urge all Florida agribusinesses to examine the regulations to determine if they are required to register with FDA,” Bronson said.  “Visit the FDA web site, or contact FDA by telephone or email if you have any questions about the registration process.  It is important that all Florida agribusinesses that are required to register be in compliance with federal law.”

Registrants must use Form 3537.  There is no fee for the registration.  Registration is required only once for each food facility, but must be updated if the information changes.  The owner, operator, or agent in charge of a domestic or foreign facility, or an individual authorized by one of them, must register the facility with FDA.  A domestic facility must register whether or not food from the facility enters interstate commerce.

Each registration must include the name, address, and phone number for the facility, and its parent company, if applicable; the name, address, and phone number of the owner, operator, or agent in charge; all trade names the facility uses; applicable food product categories as identified in FDA’s regulation 21 CFR 170.3; and statement of accuracy and authorization.

Facilities may register online at www.fda.gov/furls.  A paper copy of the form may be requested from FDA by calling 1-877-332-3882.

For questions regarding registration, contact FDA on business days from 7 a.m. to 11 p.m. by telephone at 1-800-216-7331 or (301) 575-0156, by fax at (301) 210-0247, or by email at furls@fda.gov.  Florida industries may also contact Courtney Hunt of FDA’s Tallahassee office at (850) 942-8325.

The new regulation pertains only to facilities that manufacture/process, pack, or hold food for consumption in the United States.  Examples of “food” include:

Dietary supplements and dietary ingredients
Infant formula
Beverages
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
Live food animals
Animal feeds and pet food

The following types of facilities do not have to register:

Private residences of individuals
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 (facilities handling only meat, poultry or egg products)

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