be documented on the hazard analysis for qualifying or not qualifying a known or reasonably foreseeable hazard as a hazard requiring a preventive control. For example, Salmonella is a known or reasonably foreseeable hazard in raw peanuts. The justification for qualifying Salmonella in the receiving of raw peanuts as a hazard requiring a preventive control lies in the knowledge that raw and processed peanuts have been the source of foodborne illness outbreaks responsible for severe illness and death. 8 117.135 Establish one or more 21 CFR § 117.135 requires the establishment of preventive control(s) for one or more preventive controls for each identified each identified that that require a preventive ‘hazard ‘hazard control’. require a preventive Preventive controls must be risk-based, control’ (i.e., significant hazard) reasonably appropriate procedures, practices, or such that the control processes, that control a specific hazard. The significantly minimizes or control must be capable of significantly minimizing prevents the food or preventing the associated hazard. This is manufactured, processed, consistent with the current scientific packed, or held by the understanding of safe food practices. Preventive facility from being controls must be written and may include CCPs. A adulterated under section preventive control may also be a procedure, 402 of the Federal Food, practice, or process at activities or process steps Drug, and Cosmetic Act or other than at CCPs. misbranded under section 403(w) of the Federal Food, For example, where a site handles allergenic Drug and Cosmetic Act. (e.g., tree nuts) and nonallergenic materials (e.g., dried fruit) and produces allergen-free products, tree nuts are considered to be a that ‘hazard requires a preventive because of the control’ potential for allergen cross-contact in nonallergenic products and adulteration/misbranding under FD&C sections 402 and 403. Thus, one or more preventive
be documented on the hazard analysis for qualifying or not qualifying a known or reasonably foreseeable hazard as a hazard requiring a preventive control. For example, Salmonella is a known or reasonably foreseeable hazard in raw peanuts. The justification for qualifying Salmonella in the receiving of raw peanuts as a hazard requiring a preventive control lies in the knowledge that raw and processed peanuts have been the source of foodborne illness outbreaks responsible for severe illness and death. 8 117.135 Establish one or more preventive control(s) for each identified ‘hazard that require a preventive control’ (i.e., significant hazard) such that the control significantly minimizes or prevents the food manufactured, processed, packed, or held by the facility from being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug and Cosmetic Act. 21 CFR § 117.135 requires the establishment of one or more preventive controls for each identified ‘hazard that require a preventive control’. Preventive controls must be risk-based, reasonably appropriate procedures, practices, or processes, that control a specific hazard. The control must be capable of significantly minimizing or preventing the associated hazard. This is consistent with the current scientific understanding of safe food practices. Preventive controls must be written and may include CCPs. A preventive control may also be a procedure, practice, or process at activities or process steps other than at CCPs. For example, where a site handles allergenic (e.g., tree nuts) and nonallergenic materials (e.g., dried fruit) and produces allergen-free products, tree nuts are considered to be a ‘hazard that requires a preventive control’ because of the potential for allergen cross-contact in nonallergenic products and adulteration/misbranding under FD&C sections 402 and 403. Thus, one or more preventive
vm005-brc-fsma-self-assessment-tool-3152016-3.docx