In October, we published a blog post
regarding the 2002 Bioterrorism Act which required “food facilities” to register with the FDA. Given some of the uncertainties regarding what constitutes a “food facility,” a follow up post seemed appropriate.In 2002, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act (often referred to simply as the “Bioterrorism Act”), directing the FDA to take steps to protect the general public from potential terrorist attacks on the nation’s food supply. Part of that law requires all owners, operators, or agents of facilities that manufacture, process, pack, or hold food for consumption in the U.S. to register with the FDA. The food facilities registration
can be completed online and there is no registration fee.
The regulations define “facilities” as “any establishment, structure, or structures under one ownership at one general physical location… that manufactures/processes, packs, or holds food for consumption in the United States.” 21 C.F.R. § 1.227(a)(2). Food includes alcohol beverages, such as wine. 21 C.F.R. § 1.227(a)(4)(ii).
In drafting the regulations, the FDA anticipated the potential of two or more owners sharing the same physical space. “A facility may consist of one or more contiguous structures, and a single building may house more than one distinct facility if the facilities are under separate ownership.” 21 C.F.R. § 1.227(a)(2). Thus, each alternating proprietor at a host winery must register even if the host winery has already registered.
The FDA also took into account mobile facilities that travel to multiple locations for the processing, packaging, or holding of food, unless the vehicle is being used “to hold food only in the usual course of business as carriers.” 21 C.F.R. § 1.227(a)(2). Therefore, mobile bottling units are considered facilities for the purpose of the 2002 Bioterrorism Act, and should be registered with the FDA.
Please contact us if you have any questions regarding the registration process.