Some preventive controls may not have specific parameters associated with them. For example, preventive controls for metal may include an equipment preventive maintenance program and a metal detector on the packaging line. These programs may not have specific factors that must be controlled to prevent metal contamination. Sanitation procedures may include scrubbing certain pieces of equipment by hand; this may not require the identification of specific parameters.
Proposed SEC 507.36(c)(2) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include, as appropriate to the facility and the animal food, the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur. Some of the preventive controls a facility may implement may be based upon scientific studies or other information that demonstrate the effectiveness of the control measure at specific values of a biological, chemical, physical, or radiological parameter e.g., the application of heat to animal food at a specific time/temperature combination to adequately reduce pathogens. Proposed SEC 507.36(c) would also require that a facility that establishes such a preventive control specify values of the essential parameters to be applied in implementing the control. Specifying these values would enable the facility to implement them consistently and would facilitate validation of the preventive controls as would be required by proposed SEC 507.45(a). Proposed SEC 507.36(c)(1) and (c)(2) would implement section 418(c) of the FD&C Act and are consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal regulations for seafood, juice, and meat and poultry, although there are some differences related to the differences between HACCP systems and the preventive control system established by section 418 of the FD&C Act. FSMA does not use the term "critical limit." Critical limits may not be appropriate for preventive controls that are not applied at CCPs. Thus, proposed SEC 507.36(c)(1) and (c)(2) use a broader term, i.e., parameter, to encompass preventive controls that may or may not apply at CCPs.
5. Proposed SEC 507.36(d)(1)--Process Controls
Proposed SEC 507.36(d)(1) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include process controls that include those procedures, practices, and processes performed on an animal food during manufacturing/processing that are employed to significantly minimize or prevent hazards that are reasonably likely to occur. Process controls do not include those procedures, practices, and processes that are not applied to the animal food itself, e.g., controls of personnel or the environment that may be used to significantly minimize or prevent hazards that are reasonably likely to occur but are not applied to the food itself. Specifying that process controls are employed during manufacturing/processing to significantly minimize or prevent hazards that are reasonably likely to occur would distinguish those controls applied in manufacturing/processing that significantly minimize or prevent hazards (e.g., screening, drying, cooking, and, irradiating) from other types of controls that may be applied in manufacturing/processing to provide the desired product (e.g., controls for product size and shape).
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