Restaurants that serve directly to customers are exempt from registration.
Food facilities that handle food for U.S. consumption are required to register with the FDA as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In addition, food facilities must give the FDA advanced notice of shipments of imported food. This rule applies to domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption. There are some exemptions.
Facilities that Must Register
Food production and storage facilities must register.
Any establishment that processes, manufactures, packs or holds food for consumption in the United States, including foreign establishments, must register. Examples of food include fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods.
Registration
The owner, operator or agent of a facility that manufactures, processes, packs or holds food for consumption in the United States has to register. Violations may incur withholding food from the facility. To register, go to: http://www.fda.gov/furls
Exempt Facilities
Restaurants and charitable food establishments that serve food directly to customers do not have to register. Retail food establishments are exempt from registering. Farms that produce and process food that is consumed on the farm are exempt. Facilities that are wholly regulated by the U.S.D.A.'s Federal Meat Inspection Act, Poultry Products Inspection Act or Egg Products Inspection Act are not required to register. Fishing boats that process fish only for storage purposes are exempt. Foreign facilities that send food for further processing to other facilities are exempt. Any facility that does not manufacture or process, pack, or hold food as designated in 21 CFR 1.227(b)4 are exempt." For exempt facility definitions, see Resources.
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