Proposed SEC 507.36(a) would implement section 418(c) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for juice, seafood, and meat and poultry, although there are some differences between HACCP systems and the preventive control system established by section 418 of the FD&C Act. It differs in part in that preventive controls may be required at points other than at CCPs and critical limits would not be required for all preventive controls. Under proposed SEC 507.36(a), a processor could address hazards that are reasonably likely to occur through preventive controls that would be applied at CCPs, but doing so would not be the only option available to the facility in all circumstances. In some cases adequate assurances could be achieved via preventive controls implemented through other procedures and practices of a facility, such as its control parameters for the occurrence of nutrient imbalance hazards, which may not have specific CCPs.
Whatever types of preventive controls a facility chooses to apply in its operations, the requirement in proposed SEC 507.36(a) would be risk-based. Establishing risk-based preventive controls involves consideration of the available scientific data and information related to animal food safety risks. Typically, the hazard evaluation will enable the facility to determine appropriate risk-based preventive controls for the hazard based on the severity of the hazard and the likelihood of its occurrence.
For example, as discussed in section II.F.4 of this document, Salmonella spp. is an environmental pathogen that can establish a harborage in the environment such as on a production line used in manufacturing. Once established, Salmonella spp. can intermittently contaminate products on the production line. When a hazard analysis identifies Salmonella spp. as a hazard that is reasonably likely to occur in an animal food, the facility would establish sanitation controls to prevent Salmonella spp. from establishing itself in a harborage site. In addition to such sanitation controls, a facility may consider applying a bactericidal process step (i.e., a process control applied to adequately reduce levels of Salmonella spp.) in animal foods that are handled in the home.
3. Proposed SEC 507.36(b)--Requirement for Written Preventive Controls
Proposed SEC 507.36(b) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur be written. Proposed SEC 507.36(b) would implement section 418(h) of the FD&C Act which, as discussed in section X.A.1, requires that the owner, operator, or agent in charge of a facility prepare a written food safety plan that, among other things, identifies the preventive controls within the plan. Written preventive controls are essential for the facility to implement the preventive controls consistently and essential for the facility's food safety team, auditors, and to inspectors. Written preventive controls also would be essential for training purposes and during reanalysis and updates of the preventive controls.
4. Proposed SEC 507.36(c)--Requirement for Parameters Associated With the Control of Hazards That Are Reasonably Likely To Occur
Proposed SEC 507.36(c)(1) 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, parameters associated with the control of the hazard, such as parameters associated with heat processing, irradiating, and refrigerating animal foods. The parameters are those factors that must be controlled to ensure the hazard will be significantly minimized or prevented. The specific parameters required, and how they would be controlled, would depend on the facility and the animal food. For example, for a heat process, parameters such as temperature and time must be controlled. The heating temperature may be controlled through controls on oven temperature (as when heating product in an oven). The heating time may be controlled by the belt speed for the conveyor on a continuous oven. A facility would have flexibility to establish controls on heating temperature and time through these or other mechanisms.
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