E. Proposed SEC 507.10--Applicability of Subpart C to a Facility Solely Engaged in the Storage of Packaged Animal Food That Is Not Exposed to the Environment
1. Requirements of Section 418 of the FD&C Act
Section 418(m) of the FD&C Act provides, in relevant part, that "[t]he 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. Petition Relevant to Section 418(m) of the FD&C Act
In a letter dated July 22, 2011, an industry coalition of the American Bakers Association, the American Frozen Food Institute, the Grocery Manufacturers Association, the International Bottled Water Association, the International Dairy Foods Association, the International Warehouse Logistics Association, the Peanut and Tree Nut Processors Association, and the Snack Food Association (the section 418(m) petitioners) submitted a citizen petition (Docket No. FDA-2011-P-0561). The petition requests that FDA issue regulations under section 418(m) of the FD&C Act "to exempt from compliance or modify the requirements for compliance under section 418 [of the FD&C Act] for facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment, by allowing such facilities to satisfy the requirements of that section through compliance with the [CGMPs] mandated for such facilities by [current] SEC 110.93." For full discussion of this petition, please see the discussion in section X.D of the document for the proposed rule for preventive controls for human food (78 FR 3646).
3. FDA's Tentative Response to the Petition
The Agency tentatively agrees in part, and disagrees in part, with the section 418(m) petitioners. As discussed more fully in the paragraphs that follow, FDA agrees that it is appropriate for facilities solely engaged in the storage of unexposed packaged animal food to be exempt from the requirements that would be established in proposed subpart C, provided that the animal food does not require time/temperature control for safety. For unexposed packaged animal food that requires time/temperature control for safety, FDA disagrees that such an exemption is warranted, but tentatively concludes that unexposed packaged animal food that requires time/temperature control for safety could be subject to modified requirements rather than to the full requirements that would be established in proposed subpart C.
The Agency disagrees that warehouse operators do not have access to information relevant to conducting a hazard analysis and establishing risk-based preventive controls. The principal hazard that would be identified in any hazard analysis for unexposed packaged animal food is the potential for the growth of, or toxin formation by, microorganisms of animal or human health significance when an unexposed refrigerated packaged animal food requires time/temperature control for safety. Information about this hazard and appropriate preventive controls for this hazard is widely available (Refs. 39, 40, and 41). For example, the 2009 Edition of FDA's Food Code defines "Potentially Hazardous Food (Time/Temperature Control for Safety Food)" as a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation (Ref. 39). Earlier editions (e.g., the 2001 Food Code) included a similar definition for "potentially hazardous food"; since 2005, the definition jointly refers to "potentially hazardous food" and "time/temperature control for safety food" (commonly referred to as TCS food) to emphasize the importance of temperature control in keeping food safe. Although FDA disagrees that warehouse operators do not have access to information relevant to conducting a hazard analysis and establishing risk-based preventive controls, the Agency agrees that it is not necessary for each facility solely engaged in the storage of unexposed packaged animal food to conduct its own hazard analysis to identify this hazard for unexposed refrigerated packaged animal food as reasonably likely to occur and for each such facility to determine that time/temperature control is the appropriate preventive control.