Is your winery, tasting room or food manufacturing, processing, packing or storage facility registered under the federal Bioterrorism Act? If so, did you know that this year you are required to renew your registration? Despite its sinister-sounding name, the Bioterrorism Act is nothing to fear.
Let's review some of the basics:What is the Bioterrorism Act?
According to Federal Register interim final rule 68 FR 58893, the purpose of Bioterrorism Act registration is to enable the U.S. Food and Drug Administration to act quickly in responding to a threatened or actual terrorist attack on the U.S. food supply by giving the FDA information about facilities that manufacture or process, pack or hold food for consumption in the United States.
Additionally, in the event of an outbreak of food-borne illness, such information will help the FDA and other authorities determine the source and cause of the event, and quickly notify the facilities that might be affected by the outbreak.Who is required to register?
In general, any facility engaged in manufacturing, processing, packing or holding food for consumption in the United States is required to register. Note that "food" includes alcoholic beverages. Therefore, wineries, custom-crush facilities and warehouse facilities that meet the definition will need to register.Who is exempt from registration?
Since the rules are pretty broad and complex, we're just going to focus on the likely exemptions for winery and vineyard related businesses here.
Farms don't have to register unless they are also production facilities. This exempts many grape growers from the registration requirements.
Tasting rooms don't have to register if they sell food products directly to consumers as their primary function. The FDA definition of "consumers" does not include other businesses. In order to calculate the "primary function" of a business, the test is whether the dollar value in sales of food products sold directly to consumers exceeds the value of sales to all other buyers, see www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081637.htm#IIId.
In other words, if you're selling most of your wine directly to consumers out of your tasting room then you are considered a "retail food establishment" and don't need to register. However, if your tasting room is on-site at the winery, the facility will need to register, since it will be considered a "mixed-use" facility.When do I need to register?
If you are required to register you should have done so already. The registration requirements have been in place since 2003. Registration is a fairly straightforward process and can be completed online (fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/OnlineRegistration).
If you are already registered, it's time to re-register. Registration renewal is required under 21 U.S. Code Section 350d(a)(3). Specifically, during the period beginning on Oct. 1 and ending on Dec. 31 of each even-numbered year, such as 2012, each registrant must renew its registration.How do I register?
You can mail in the questionnaire, or submit it online. Information on how and when to register can be found at fda.gov/Food/FoodSafety/FSMA/ucm314178.htm?source=govdelivery. While you may have read that renewal registrations were not yet open, the FDA site has recently begun accepting renewals.•••
Caroline Boller (707-524-7000, firstname.lastname@example.org) is an associate attorney in Dickenson, Peatman & Fogarty's Business Department and based in the firm's Santa Rosa office. Her practice areas are real property and business. Reprinted, with permission, from the firm's wine law blog, Lex Vini (lexvini.blogspot.com).