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 by December 12, 2003.
Last updated February 3, 2007

• What You Need to Know About Registration of Food Facilities - FDA booklet - November 2003
• Questions and Answers Regarding Registration of Food Facilities (Edition 4)* Final Guidance August 2004
• Questions and Answers Regarding Registration of Food Facilities - FDA Guidance for Industry - December 2003
• FDA pledges education on bioterrorism rules - The Packer - December 17, 2003

Who is required to register?

• Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.

• Examples of FDA-regulated foods and food additives for humans or animals include:

  Dietary supplements and dietary ingredients Infant formula Beverages (including alcoholic beverages and bottled water) Fruits and vegetables Fish and seafood Dairy products	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
  (complete list)

Who does not have to register?

Farms Private residences of individuals Retail food establishments Restaurants Non-profit establishments that prepare food for, or serve food directly to, consumers Transport vehicles that hold food only in the usual course of their business as carriers. Facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture Fishing vessels not engaged in processing Non-bottled water, drinking water collection and distribution establishments and structures, such as municipal water systems

(Further explanation of criteria for exemption)

Is there a fee to register?

• There is no fee to register.
• FDA has advised registrants that registration is easy and free and to be cautious when companies offer to assist with registration for a fee here

How do I register?

• Registrations can be submitted electronically via the Internet, through surface mail on a paper form or a CD-ROM, or through fax
  • Instructions for registering by mail or fax (download a form here)
  • Instructions for online registration

What information Is required?

• Name
• Physical address
• Phone number of the facility and parent company, if the facility is a subsidiary
• All trade names the facility uses
• Food product categories (21 CFR 170.3)
• A statement certifying that the information submitted is true and accurate and submitter is authorized to register the facility
• Name and contact information of the person submitting the certification statement
• Name of foreign facility's U.S. agent, if applicable, and the agent's contact information
• Emergency contact information

• Registration is easy, free, and required by law.
• Food manufacturers need to register by December 12, 2003.
• FDA will initially take an educational rather than enforcement approach for the first several months of the regulation.
• However, repeated failures to register can bring a civil action in Federal court or the Federal government can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act.

For help with registration, contact FDA
In the U.S call 1-800-216-7331 or 301-575-0156
From elsewhere call 301-575-0156
Fax questions to 301-210-0247
Email questions to furls@fda.gov

or contact

Luke LaBorde
Associate Professor of Food Science
Penn State University
lfl5@psu.edu