14 117.165 (b) Where product testing for a Product testing for a pathogen (or indicator pathogen (or indicator organism) or other hazard is a defined verification organism) or other hazard is activity in 21 CFR § 117.165 of the regulation. used as a verification Where product testing is used as a verification activity, a scientifically valid activity, the site must establish and implement a and written testing scientifically valid testing procedure, which defines procedure must identify the sampling, frequency, test method, laboratory, and following: corrective action procedure. Generally, expectations to meet this requirement are defined sampling by BRC clause 5.6.2.3. procedure to include method, Where product testing is used as a verification quantity, activity to confirm the effective implementation of frequency, and a preventive control, the site should reanalyze the number of samples applicable procedures for analyses that are critical analytical method to safety and legality and update them as laboratory conducting an necessary to ensure that the procedure(s) analysis documents all requirements of the regulation. corrective action procedure where a pathogen is detected. 15 117.165 (c) Where environmental Environmental monitoring for a pathogen (or monitoring for a pathogen indicator organism) is a required verification (or indicator organism) is activity as defined in 21 CFR § 117.165 of the used as a verification regulation where RTE product is exposed to the activity, a scientifically valid environment before being packaged and the and written testing packaged food does not receive a kill step to procedure must identify the eliminate or significantly minimize the pathogen. following: Where environmental monitoring is applied as a verification activity for exposed RTE product, the adequate number site must establish and implement a scientifically and location of valid testing procedure, which defines sampling sample sites (including location of sites), timing and frequency, timing and test method, laboratory, and the corrective action frequency of sampling
14 117.165 (b) Where product testing for a pathogen (or indicator organism) or other hazard is used as a verification activity, a scientifically valid and written testing procedure must identify the following: sampling procedure to include method, quantity, frequency, and number of samples analytical method laboratory conducting an analysis corrective action procedure where a pathogen is detected. Product testing for a pathogen (or indicator organism) or other hazard is a defined verification activity in 21 CFR § 117.165 of the regulation. Where product testing is used as a verification activity, the site must establish and implement a scientifically valid testing procedure, which defines sampling, frequency, test method, laboratory, and corrective action procedure. Generally, expectations to meet this requirement are defined by BRC clause 5.6.2.3. Where product testing is used as a verification activity to confirm the effective implementation of a preventive control, the site should reanalyze the applicable procedures for analyses that are critical to safety and legality and update them as necessary to ensure that the procedure(s) documents all requirements of the regulation. 15 117.165 (c) Where environmental monitoring for a pathogen (or indicator organism) is used as a verification activity, a scientifically valid and written testing procedure must identify the following: adequate number and location of sample sites timing and frequency of sampling Environmental monitoring for a pathogen (or indicator organism) is a required verification activity as defined in 21 CFR § 117.165 of the regulation where RTE product is exposed to the environment before being packaged and the packaged food does not receive a kill step to eliminate or significantly minimize the pathogen. Where environmental monitoring is applied as a verification activity for exposed RTE product, the site must establish and implement a scientifically valid testing procedure, which defines sampling (including location of sites), timing and frequency, test method, laboratory, and the corrective action