Continuous monitoring is possible with many types of physical and chemical parameters. For example, the temperature and time for many thermal processes can be recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the affected product can be retained and evaluated to determine the appropriate disposition. Examples of other parameters that can be monitored continuously include pressure, flow rate, and pH.
Continuous monitoring may not be possible, or even necessary, in all cases. For example, it may not be practical to continuously monitor the size of particles in a food to ensure they do not exceed the maximum dimensions that are required to ensure a process such as cooking, cooling, or acidification can be properly implemented. If monitoring is not continuous, it may be difficult to ensure that the preventive controls are consistently implemented and a problem has not occurred. Thus, according to NACMCF, the frequency of non-continuous monitoring must be sufficient to ensure that a CCP (or, in the case of this proposed rule, a preventive control) is under control (Ref. 31). The Codex HACCP Annex also notes that, if monitoring is not continuous, then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in control (Ref. 36). The frequency of non-continuous monitoring would depend on factors such as the proximity of operating conditions to the conditions needed to ensure safety and the variability of the process. For example, if the temperature needed to ensure safety of baked pet treats is 300 [degrees] F, non-continuous monitoring would need to be more frequent when an oven for baking pet treats is operated at 350 [degrees] F than when the oven is operated at 400 [degrees] F. As another example, if temperatures vary by 30 [degrees] F during processing, monitoring would need to be more frequent than if the variation is only 10-15 degrees.
c. Proposed SEC 507.39(c)--Requirement for records. Proposed SEC 507.39(c) would require that all monitoring of preventive controls in accordance with proposed SEC 507.39 be documented in records that are subject to verification in accordance with SEC 507.45(b)(1) and records review in accordance with 507.45(c)(1)(i) and (c)(2). Proposed SEC 507.39(c) would implement section 418(g) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. Further discussion monitoring under HACCP systems can be found in section XII.E of the proposed rule for preventive controls for human food (78 FR 3646).
The monitoring records would be used to verify that the preventive controls are adequate, as would be required by proposed SEC 507.45(a), and to verify that the preventive controls are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur, as would be required by proposed SEC 507.45(d).
Together, proposed SUBSEC 507.39(a), (b), and (c) and 507.45(a), (b), and (d) would establish a system that would provide assurance that hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented and that food manufactured, processed, packed or held by such facility will not be adulterated under section 402 of the FD&C Act.
F. Proposed SEC 507.42--Corrective Actions
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