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New bioterror rules may affect farmers

Some Farm Bureau members will be required to register as food facilities according to newly published rules resulting from the Bioterrorism Act of 2002. The registration deadline is Dec. 12.

According to a Food and Drug Administration fact sheet, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) 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. In the event of a potential or actual bioterrorism incident or an outbreak of food-borne illness, facility registration information will help FDA determine the location and source of the event and permit the agency to quickly notify facilities that may be affected.

Who must register?

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. Farmers who process their food products and sell that processed product to another business entity will need to register. Farmers who pack or hold food produced by another farmer and sell that product to another business entity will need to register. OFBF is clarifying with FDA if freezing produce, maple syrup and honey production, baled hay, baled or ensiled corn residue and silage are considered processed foods. OFBF is also clarifying registration requirements for farmers markets and produce auctions.

What types of facilities do not have to register? (Partial list)

  • 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. Washing, trimming of outer leaves, and cooling of produce are considered part of harvesting. The term "farm" also includes facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership, and facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
  • 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. An establishment that manufactures/processes, packs, or holds food and whose primary function is to sell food directly to consumers, including food that the establishment manufactures/processes, from that establishment is a retail food establishment and is not required to register.
  • 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.

Facilities can register online via the Internet, by completing a paper form, or submitting to FDA a CD-ROM with relevant registration information. For assistance with online registration: in the U.S call 800-216-7331 or send a fax to 301-210-0247. Requests for assistance also may be emailed to furls@fda.gov The Online Registration Help Desk will be staffed on business days from 7 a.m. until 11 p.m.

 
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