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The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, otherwise known as the Bioterrorism Act, requires domestic and foreign facilities to register with FDA if they manufacture, process, pack or hold food for human or animal consumption in the U.S. The purpose of registration is to provide FDA with sufficient and reliable information about food and feed facilities.
Examples of FDA-regulated “foods” 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
Both domestic and foreign farms do not need to register if they fall within the following criteria established by FDA:
- 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.
- 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.
By this definition, packing houses that pack foods other than those owned by them need to register. The Bioterrorism Act makes failure to register a prohibited act. In August 2006, FDA published a revised Compliance Policy Guide (CPG).
There is a thorough Q&A outlining who is currently required to register at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/fooddefense/ucm082703.htm
FDA Food Facility Registration
*Biennial Registration Renewal for Food Facilities begins on October 22, 2012. At that time, the food facility registration system will be accepting food facility registration renewals.
Food Facility Registration: Who, How and When?
This document was developed by the NCDA&CS Food and Drug Protection Division to help food facilities, including certain farms, determine whether they need to register with the FDA, and to provide information on the registration process.