Monitoring and verification are closely related; both address the performance of preventive controls, and verification relies in part on monitoring records to establish that preventive controls developed to significantly minimize or prevent hazards are being implemented according to plan. Three provisions of section 418(f) of the FD&C Act (Verification) are particularly relevant when considering the role of monitoring. First, section 418(f)(1) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that "the preventive controls implemented . . . are adequate to control the hazards identified . . . " Second, section 418(f)(2) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that "the owner, operator, or agent is conducting monitoring . . ." Third, section 418(f)(4) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that "the preventive controls implemented . . . are effectively and significantly minimizing or preventing the occurrence of identified hazards . . ."
3. Monitoring the Performance of Preventive Controls
Section 418(a) requires monitoring the "performance" of preventive controls whereas section 418(d) requires monitoring their "effectiveness." The Agency tentatively concludes that the language of section 418 regarding monitoring is ambiguous and that it would be appropriate to require monitoring of the performance of preventive controls. "Performance" means "the execution or accomplishment of an action, operation, or process undertaken or ordered" (Shorter Oxford English Dictionary, Fifth Ed. (2002), p. 2157) and is consistent with use of "monitoring" in traditional HACCP. Monitoring the performance of preventive controls would be undertaken to determine whether a facility is implementing its preventive controls and would generate records that would be used to verify implementation of the controls. For example, monitoring performance could include visual observation and measurements of temperature, time, pH, and moisture level. In contrast, "effectiveness" refers to the quality of "having an effect or result" (Shorter Oxford English Dictionary, Fifth Ed. (2002), p. 794) and is not consistent with use of the term "monitoring in traditional HACCP. The term "verification," not "monitoring" is used to refer to effectiveness in traditional HACCP systems. Monitoring the effectiveness of preventive controls would evaluate whether the preventive controls were working.
Requiring monitoring of the effectiveness of the preventive controls would be redundant with required verification activities. Section 418(f) requires verification that the preventive controls are "effectively and significantly minimizing the occurrence of the identified hazards . . ." The activities necessary for such verification are the same as would be required for monitoring the effectiveness of the preventive controls. Requiring monitoring of effectiveness rather than performance of the preventive controls would create a significant gap in the preventive controls system. In contrast, monitoring the performance of preventive controls would provide evidence that the preventive controls established to control the identified hazards are implemented appropriately and thereby are effectively and significantly minimizing or preventing hazards.
Section 418(n)(5) of the FD&C Act directs the Secretary, in issuing these regulations, to review hazard analysis and preventive control programs in existence to ensure that this regulation is consistent to the extent practicable with applicable domestic and internationally-recognized standards in existence. Requiring monitoring of the performance of preventive controls is consistent with applicable domestic and internationally recognized standards.
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