Page 7 - Beverage Master June-July 2018
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Craft Beverage

               ism best practices used by large public companies,     As part of the registration, the craft beverage
               and smaller companies as well.  No matter how you  company must agree to allow agents of the FDA
               cut it, change happened.                             to inspect the company’s facility. The inspection
                                                                    usually happens at a reasonable time with reason-
                                   THE ACT                          able notice assuming there is no indication that the
                                                                    subject of the inspection will be tampered with or
                 The Public Health Security and Bioterrorism        destroyed. “Food” facilities are required to register
               Preparedness and Response Act of 2002 (the Act)      with the FDA and to renew such registrations every
               affects craft beverages sold to the public in the    other year.
               US. The purpose of the Act is to protect US food
               supplies against acts of bioterrorism and food and     At a minimum, the FDA can suspend the regis-
               beverage borne illnesses. The Act was written to     tration of a food facility if it determines that food
               include alcoholic beverages as “food” so I use the   manufactured, processed, packed, received, or held
               words “food” and “beverages” to have the same        by a registered food facility has a reasonable proba-
               meaning.                                             bility of causing serious adverse health consequenc-
                                                                    es or death to humans or animals. The FDA may by
                 Though not every large-scale, public outbreak of   order suspend the registration of a facility where
               E.coli, salmonella or food poisoning is attributed to   people at that facility:
               bioterrorism; a fleeting thought now crosses our
               mind each time food or drink is contaminated and     1.  Created, caused, or was otherwise responsible
               sickens a large group of people isolated to a part of    (e.g., bottled), or if there is a reasonable prob-
               the US. Was this contamination done intentional-         ability that people at the facility were responsi-
               ly? Usually not, but we do think about it. I’m sure      ble, for such contamination; or
               that my grandfather never considered it as even
               remotely possible.                                   2.  They knew of, or had reason to know of, such
                                                                        reasonable probability of contamination; and
                                  THE RULES                             the contaminated food was packed (bottled),
                                                                        received, or held at the facility.
 CRAFT BEVERAGES & BIOTERRORISM     In accordance with the Act, craft beer makers sell-  B.  Notify. If the craft beer is imported into the US,
               ing beverages to the public in the US must, under
               certain circumstances:
                                                                        the importer of record must provide the FDA
 By: Dan Minutillo, APC                                                 with prior notice of “food” imported or offered
               A.  Register. FDA food facility registration is          for import into the US by notifying the Bureau
                  required if a domestic or foreign food facility       of Customs and Border Protection or providing
                  manufactures, processes, packs, or holds food         such notification through the FDA notice sys-
                  to be sold to the US public.                          tem.

                 Let’s break this down. This part of the Act is       This notification process is not difficult but it must
               straightforward. A US food facility registration is   be accomplished if required. The problem is getting
               required if the manufacturing facility in question   the word out to businesses that such notification is
               is located in the US or abroad and almost anything   required so the appropriate personnel can comply.
               is done to the food (remember that alcoholic bev-
               erages are considered a “food”) to prepare it for    C. Record. The Act indicates that records must be
               public consumption including bottling if that food is   held for possible later inspection by the agents
               sold to the public in the US.                           of the FDA.  Recordkeeping applies to domestic
                                                                       persons in the US that manufacture, process,
                 This registration relates to the FDA Food Safety      pack, transport, distribute, receive, hold or
               Modernization Act enacted on January 4, 2011,           import food; foreign persons that transport
               requiring facilities engaged in manufacturing, pro-     food; and persons who place food directly in
               cessing, packing, or holding food for consumption       contact with its finished container (bottling). For
               in the US to submit information to the FDA as part      these regulations, the term persons include indi-
               of a detailed registration process.                     viduals, partnerships, corporations, and associa-

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