4. Proposed SEC 507.10--Applicability of Part 507 to a Facility Solely Engaged in the Storage of Packaged Animal Food That Is Not Exposed to the Environment
Proposed SEC 507.10(a) would provide that 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(b) would establish that unexposed packaged animal food at such facilities is subject to modified requirements that would be established in proposed SEC 507.48. As discussed more fully in section X.I, the modified requirements would mandate that such a facility establish and implement appropriate temperature controls, monitor the temperature controls, take corrective actions, verify that the temperature controls are consistently implemented, and establish and maintain records documenting the monitoring, corrective actions, and verification activities for unexposed refrigerated packaged TCS animal food. These modified requirements would be a subset of the proposed requirements that would be established in subpart C.
There are limited routes of contamination for unexposed packaged animal food in a facility that solely stores unexposed packaged animal food (e.g., packaged animal food in containers in a warehouse). Contamination can occur, for example, if rodents gnaw through packages or if human waste from an improperly maintained toilet facility spills and seeps into paper-based packaging. However, with one exception, the CGMP requirements in proposed subpart B (e.g., proposed SUBSEC 507.17, 507.19, 507.20, and 507.28) would apply to the storage of unexposed packaged animal food and be adequate to prevent such contamination so that it would not be necessary for the owner, operator, or agent in charge of a facility to address these routes of contamination by applying the hazard analysis and risk-based preventive controls that would be established in proposed subpart C. The exception would be for the rare circumstances in which RACs are packaged in a manner in which the RACs are not exposed to the environment. An establishment solely engaged in storing RACs would be exempt from CGMPs in proposed subpart B. Such an establishment would continue to be subject to section 402(a)(4) of the FD&C Act. An establishment that is solely engaged in the storage of packaged RACs that are not exposed to the environment may find the provisions of proposed subpart B helpful in ensuring compliance with section 402(a)(4) of the FD&C Act.
Many of the requirements that would be established in proposed subpart C would be directed to manufacturing, processing, and packing animal food and would not apply to the storage of unexposed packaged animal food that does not require time/temperature control for safety. This is the case for:
* Process controls (proposed SEC 507.36(d)(1));
* Sanitation controls (proposed SEC 507.36(d)(2));
* Monitoring of process controls and sanitation controls (proposed SEC 507.39);
* Corrective actions (proposed SEC 507.42);
* Verification (including initial validation) of process controls (proposed SEC 507.45); and
* A recall plan (proposed SEC 507.38) (recalls generally are initiated by the manufacturer, processor, or packer of the animal food).
FDA tentatively concludes that the outcome of a hazard analysis for storage of unexposed packaged animal food that does not require time/temperature control for safety is that there are no hazards reasonably likely to occur. FDA also tentatively concludes that there would be little animal and human health benefit to requiring the owner, operator, or agent in charge of each facility solely engaged in the storage of such animal food to conduct its own hazard analysis and document that outcome in its own animal food safety plan. Likewise, FDA tentatively concludes that there would be no need for the facility to establish and implement preventive controls, with corresponding monitoring, corrective actions, or verification (including validation), because there would be no hazards reasonably likely to occur to trigger such activities. FDA also tentatively concludes that there would be no need for a qualified individual to conduct activities such as preparing the animal food safety plan (proposed SEC 507.30(c)); validating the preventive controls (proposed SEC 507.45(a)); reviewing records for implementation and effectiveness of preventive controls and appropriateness of corrective actions (proposed SEC 507.45(c)); or performing reanalysis of the animal food safety plan (proposed SEC 507.45(e)(4)), because the facility would not need to conduct these activities. Thus, with the exception of the unexposed refrigerated packaged TCS animal food, FDA tentatively concludes that the animal food safety system that would be established in proposed subpart C is not needed to significantly minimize or prevent the occurrence of hazards that could affect unexposed packaged animal food at a facility solely engaged in the storage of such animal food.