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Tuesday, October 23, 2012

Wineries and Vineyards Need Not be Frightened by Bioterrorism Act Rules and Requirements

Is your winery or tasting room registered under the Bioterrorism Act?  If so, did you know that this year you are required to renew your registration?  If not, are you sure you’re not required to register?  Despite its sinister-sounding name, the Bioterrorism Act is nothing to fear.  Let’s review some of the basics:

1.         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 FDA to act quickly in responding to a threatened or actual terrorist attack on the U.S. food supply by giving FDA information about facilities that manufacture/process, pack, or hold food for consumption in the United States.  Additionally, in the event of an outbreak of foodborne illness, such information will help FDA and other authorities determine the source and cause of the event, and quickly notify the facilities that might be affected by the outbreak.

2.            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. 

3.            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. 

               A.            Farms don’t have to register unless they are also production facilities.  This exempts many grape growers from the registration requirements.     

               B.            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: http://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.    

4.            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:  http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/OnlineRegistration/ucm125055.htm


If you are already registered, it’s time to re-register!  Registration renewal is required under 21 U.S.C. § 350d(a)(3).  Specifically, during the period beginning on October 1 and ending on December 31 of each even-numbered year, each registrant must renew their registration.

5.            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: http://www.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. 

For assistance with the registration process or with other questions related to winery or grower issues, please contact Caroline Boller at cboller@dpf-law.com      


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