* Verify that the preventive controls are adequate to control the hazards the owner, operator, or agent is conducting monitoring and is making appropriate decisions about corrective actions and the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards and there is documented, periodic reanalysis of the plan under section 418(i) of the FD&C Act to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats (section 418(f) of the FD&C Act);
* Maintain, for not less than 2 years, records documenting the monitoring of the preventive controls instances of nonconformance material to food safety and instances when corrective actions were implemented (section 418(g) of the FD&C Act);
* Prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act, including analyzing the hazards and identifying the preventive controls adopted to address those hazards section 418(h) of the FD&C Act);
* Conduct a reanalysis under section 418(b) of the FD&C Act whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier (section 418(i) of the FD&C Act).
In addition to these requirements directed to the owner, operator, or agent in charge of a facility, section 418(m) of the FD&C Act provides, in relevant part, that the Secretary may, by regulation, exempt or modify the requirements for compliance under section 418 of the FD&C Act with respect to facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment.
2. Approach to Modified Requirements Under Section 418(m) of the FD&C Act
As discussed in section VIII.E of this document, proposed SEC 507.10 would both provide that proposed part 507 subpart C does not apply to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment (proposed SEC 507.10(a)) and establish that such a facility is subject to modified requirements in proposed SEC 507.48 (proposed SEC 507.10(b)). In the remainder of the discussion of these modified requirements, the Agency refers to "packaged food that is not exposed to the environment" as "unexposed packaged animal food," and to "unexposed refrigerated packaged animal food that requires time/temperature control for safety" as "unexposed refrigerated packaged TCS animal food." As noted in section VIII.E, the Agency considers "not exposed to the environment" and "unexposed" to mean that the animal food is in a form that prevents any direct human contact with the food. The modified requirements in proposed SEC 507.48 would apply to unexposed refrigerated packaged TCS animal food. In essence, proposed SEC 507.48 distinguishes between unexposed packaged animal food and unexposed refrigerated packaged TCS animal food. This distinction is based on hazards that are reasonably likely to occur during the storage of unexposed refrigerated packaged TCS animal food, but are not reasonably likely to occur during the storage of unexposed packaged animal food that does not require time/temperature control for safety.
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