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
the hazard, control, and role in the food safety system. Sites should reanalyze all identified preventive controls and consider the need for validation where this is not presently documented. 13 117.165 (a) The PCQI (or authorized designee) reviews the monitoring and corrective action records within 7 days. Where an alternate timeframe exceeding 7 days is used, the PCQI must document justification. The PCQI (or their authorized designee) reviews the verification records for all preventive controls (e.g., calibration records, product testing, supply-chain audits) within a reasonable timeframe after the record has been created. The review of records related to the implementation and management of preventive controls is defined as a core verification activity in the regulation. The PCQI has overall responsibility for it to ensure that any failure in implementing preventive controls is identified within an appropriate timeframe to prevent adulterated product from reaching consumers. 21 CFR § 117.165 requires the PCQI to conduct (or oversee) record reviews for monitoring and corrective action records within 7 days and all verification records within a reasonable timeframe. This requirement is consistent with the monitoring expectations for record review, as defined in BRC clause 2.10.2. Consideration should be given to the 7-day timeframe; where a timeline exceeding 7 days is used, the PCQI must document justification. Requirements for the review of corrective action and verification records are implied in BRC clauses 2.12.1 and 3.7.2. The corrective action and verification procedures related to the food safety plan should be evaluated and updated as necessary to ensure there is provision for records to be reviewed by the PCQI or their designee.