5. Proposed SEC 507.45(b)(3)--Implementation and Effectiveness
Proposed SEC 507.45(b)(3) would require that the owner, operator, or agent in charge of a facility verify the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur, including the requirements in proposed SEC 507.45(b)(3) and SEC 507.45(c), as appropriate to the facility and the animal food. Proposed SEC 507.45(b)(3) and (c) would implement section 418(f)(4) of the FD&C Act, which requires in relevant part verification by "appropriate means" that the preventive controls "are effectively and significantly minimizing or preventing the occurrence of identified hazards."
a. Proposed SEC 507.45(b)(4)--Calibration. Proposed SEC 507.45(b)(4) would require calibration of process monitoring instruments and verification instruments. The combination of monitoring (proposed SEC 507.39(a)), recordkeeping (proposed SEC 507.55), and verification (proposed SEC 507.45(a), (b)(4), and (c)) 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 would be significantly minimized or prevented and that animal food manufactured, processed, packed, or held by such facility would not be adulterated under section 402 of the FD&C Act. In many instances, monitoring and verification activities rely on instruments (such as a weigh scale or a thermometer) that must be calibrated. Calibration provides assurance that an instrument is measuring accurately. If these instruments are not properly calibrated, the values they provide may not provide the necessary assurance that hazards will be significantly minimized or prevented. If an instrument is calibrated against a known reference, the reference standard may also need periodic calibration (e.g., the standard reference thermometer used to calibrate a thermometer used in processing equipment will itself also need to be calibrated periodically).
Instrument calibration is performed on a regular or periodic basis based upon the type of instrument being used and its sensitivity to factors such as the operating environment and the wear and tear of ongoing use. The type of instruments used in a particular facility and the manner of their use will largely determine the need for, and the frequency of, calibration, and the frequency of calibration is often prescribed by the instrument manufacturer. Therefore, proposed SEC 507.45(b)(4) would not specify a frequency for calibration.
b. Proposed SEC 507.45(c)--Records review. Proposed SEC 507.45(c) would require a review of specific records related to monitoring, corrective actions, and other verification activities within specified timeframes, by (or under the oversight of) a qualified individual, to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decisions were made about corrective actions. Proposed SEC 507.45(c)(1)(i) would require review of the monitoring and corrective action records within a week after the records are made. Proposed SEC 507.45(c)(1)(ii) would require review of the records related to calibration of instruments within a reasonable time after the records are made. (As discussed in section X.J, proposed SEC 507.55 would list the records that facilities must establish and maintain, including records that document the monitoring of preventive controls as required by SEC 507.39(c), corrective actions as required by SEC 507.42(d), and verification activities as required by SEC 507.45(f)). Proposed SEC 507.45(c) would implement section 418(f) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP guidelines, and Federal HACCP regulations for seafood, juice, and meat and poultry.
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