Bioterrorism Registration
Registration is an FDA requirement per the Public Health Security and Bioterrorism and Response Act of 2002 (Bioterrorism Act).
Source: FDA registration information
Registration Information
How do I register?
You can register at FDA's Bioterrorism Registration page.
What is the Bioterrism Act?
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.
What does the Bioterrorism Act require?
The Bioterrorism Act requires owners, operators, or agents in charge of domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register their facilities with FDA, unless the facility is exempted.
Why register?
Changes made by the Food Safety and Modernization Act (FSMA) to the Federal Food, Drug, and Cosmetic Act now require all seafood processing vessels and land based food manufacturers to renew their registration, including previously registered firms. All firms will be required to renew their registration every 2 years beginning October 1 and ending on December 31 of each even numbered year.
Who must register?
Owners, operators, or agents in charge of facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register their facilities with FDA. Fishing vessels that otherwise engage in processing fish are also required to register.
What is considered processing?
Processing means handling, storing, preparing, shucking, changing into different market forms, manufacturing, preserving, packing, labeling.
Who is exempt?
The Bioterrorism Act exempts fishing vessels, including those that not only harvest and transport fish, but also engage in practices such as heading and eviscerating solely to preserve freshness.
I already registered, do I have to reregister?
Yes. Even firms that have previously registered will be required to renew their registration.
How often will we be required to register?
All firms are required to renew their registration every 2 years beginning on October 1 and ending on December 31 of each even-numbered year.
Where can I find additional information?
You can find more information on FDA's Food Registration web page.
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