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H.S. CROCKER BIOTERRORISM COMPLIANCEFrom the Compliance Policy Guide – FDA publication- Registration of Food Facilities Under the Public Health and Security and Bioterrorism Preparedness and Response Act of 2002. Section 110.300: Registration of Food Facilities Under the Public Health and Security and Bioterrorism Preparedness and Response Act of 2002. (Codified at 21 CFR 1.225- 1.243). The Bioterrorism Act, as implemented by the interim final rule for registration of facilities (68 Fed. Reg. 58894; October 10,2003; codified at 21 CFR Part 1, Subpart H), exempts the following from registration: “Certain other establishments are not required to be registered because they do not manufacture/process, pack, or hold “food” as defined in the registration regulation ( 21 CFR 1.227(b)(4). This definition excludes food contact substances (including packaging materials) as defined in § 409(h)(6) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348 (h) (6), and pesticides as defined in 7 U.S. C. 136(u). Thus the facilities that manufacture/process, pack, or hold only food contact substances or only pesticides are not required to be registered”. The above information from: http://www.fda.gov/ora/compliance Due to this final rule, H.S. Crocker being exempt does not have an established formal Bioterrorism Plan, however our building is a secured facility with entry controlled by key cards, and the entire plant is under video surveillance 24-7. Per our SOP our personnel are trained in controlling access to our building and plant.
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