Do You Need a Bioterrorism Registration Number?

Posted on by Kelsey Sullivan

Have you ever heard of a Bioterrorism Registration Number?

 

Hopefully you have if you are in the food industry. I personally had never heard of it until one of our customers had some questions about the requirements. Their company produces a product in their home kitchen, where they package it, label it, and sell it directly online and to restaurants. This company wanted to find out if they needed to register for a Bioterrorism Registration Number.  I decided to do some research, and here is what I’ve found.

Cookie Factory

 

What is the Bioterrorism Act, and who must register under it?

The 2002 Bioterrorism Act (officially named the Public Health Security and Bioterrorism Preparedness and Response Act) made it so any facility that manufactures, packs, processes, or holds food must register with the Food and Drug Administration. The FDA defines facility as “any establishment, structure, or structures under one management at one general physical location, or in the case of a mobile facility, traveling to multiple locations that manufactures/processes, packs, or holds foods intended for human or animal consumption in the United States.”

Who does not need to Register for a Bioterrorism Number?

According to www.fda.gov , this means that private residences, restaurants, retail food locations, nonprofit food establishments, fishing vessels and facilities that are completely regulated by the U.S.D.A do not need to register.

Why was the Bioterrorism Act created?

The FDA explains that the Act was passed in order to, “protect the public from a threatened or actual terrorist attack on the U.S. food supply.” If there were ever to be a widespread issue of foodborne illnesses then the registration information the FDA has would be utilized to try to pinpoint where the illness originated and rapidly control the outbreak.

What happens if one of the required facilities doesn’t register?

If one of the required facilities does not register for a Bioterrorism Registration Number, their food may not be sold in the United States.  So, if you have a business that manufactures, processes, packs, or holds food you may be wondering if you could be in trouble for not doing this.

Who is exempt from the Bioterrorism Act?

Not to worry, there are several reasons you may not be required to register for a Bioterrorism Number, even if you meet the general guidelines. For example, if you operate out of your home it would not be necessary. Products coming out of private residences are not required to be registered under this Act. Also included are restaurants, charitable food establishments, fishing boats, grocery stores, farms, municipal water systems.

Therefore, it seemed to make sense that our customer did not need to register. This business recently started outgrowing the owner’s kitchen, so they expanded into the kitchen of a pre-existing garage apartment at the end of their driveway. Since the garage apartment is a normal part of a residential property, they still do not need to register.  However, if they built a large factory specifically for their product they would need to register, even if still living on the property.

How to register for a Bioterrorism Number

If you are realizing that you should probably be registered under this Act, don’t panic. You can avoid being prosecuted (yikes!) by the government by registering easily. Registration is a one time action, and there are no fees involved in registering.

If you have been required to register under this act I want to hear about you, your product, and your packaging and labels. If you have a product that you make and/or package from your residence and are planning on expanding I’d love to hear any questions or information about this process as well!

 

Resources:

http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm

http://www.tradelaw.com/tt_news1.php?table=news&doc_id=29

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