Food Facilities Must Register With U.S. FDA By December 12, 2003
On October 10, 2003 the United States Food and Drug Administration (FDA) adopted an interim final regulation entitled "Registration of Food Facilities." This regulation was adopted in response to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The FDA believes that this registration will allow the FDA to quickly react in the event of a bioterrorism threat to the nation's food supply.
Who has to register with the FDA?
This interim regulation requires domestic facilities or foreign facilities that manufacture/process, pack or hold food for human or animal consumption to register with the FDA by December 12, 2003.
Please note that this regulation only applies to facilities that manufacture/process, pack, or hold food for consumption in the United States. Examples of food include dietary supplements, infant formula, beverages (including alcoholic beverages and bottled water) fruits and vegetables, fish and seafood, dairy products, raw agricultural products 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.
Under this first set of rules, grocery stores and other retailers will not have to register with the FDA as a "food facility.” However, it is highly likely that a retailer's distribution center and a retailer's wholesaler suppliers will be required to register. Additional regulations will be available in early December which will require all food retailers to undergo significant changes in their store operations, including registration of retail stores.
Who is exempt from registration?
The FDA has listed several entities that are not required to register. These include retail food establishments, restaurants, private residences, non-bottled water drinking collection sites (municipal water systems), farms devoted to the growing and harvesting of crops, nonprofit food establishments (soup kitchens, food banks) and facilities handling only meat, poultry or egg products that are exclusively regulated by the U.S. Department of Agriculture.
The key to whether or not a retailer has to register is if the retailer's primary function is to sell food directly to consumers - even if some of the food is manufactured by the retailer. Retail food establishments (including groceries, delis and roadside stands) that sell food as their primary function are exempt from the registration requirements. Selling food to a consumer is a retailer's primary function when the annual sales directly to consumers are of greater dollar value than annual sales to other buyers. U.S. Club stores that sell 51 or more percent of their food products to consumers are also exempt from the registration requirement.
What information do I have to provide?
Each registration must contain: 1) the name, address and phone number for the facility and its parent company (if applicable); 2) the name, address and phone number of the owner, operator or agent in charge; 3) all trade names the facility uses; 4) the applicable food product categories as defined in the FDA's regulation (21 CFR 170.3); (5) a statement certifying that the information submitted is true and accurate and that the person submitting the registration - if not the owner, operator or person in charge - is authorized to submit the registration application. There is additional information that a food facility may provide that the FDA believes will help in communicating with facilities in the event of a bioterrorism threat to the food supply. None of the registration information is available to the public. If a food facility’s registration information changes, the food facility must update their registration information within 60 days.
How do I register?
Registration may be completed online at www.fda.gov/furls or by calling 1-800-216-7331 (from 7 a.m. until 11a.m. EST) beginning October 16, 2003. Registration is free. CD-ROMs may be utilized for multiple location registration. The FDA is encouraging electronic registration. If a company does not have Internet access to a form, a form may be obtained by calling 1-877-332-3882 or by mailing a request to: U.S Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857.
What if I do not register?
Failure to register is a violation of the Federal Food, Drug and Cosmetic Act subjecting you to both criminal and civil liability.
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