In a situation where the owner, operator or agent in charge of a facility does not have information from the manufacturer, processor, or packer of the food about whether an unexposed refrigerated packaged animal food requires time/temperature control for safety and, if so, what specific temperature controls are necessary for safe storage of the food, the owner, operator, or agent in charge of the facility could either consult the scientific and technical literature to determine whether a particular food is a TCS animal food or assume that any unexposed refrigerated packaged food is a TCS animal food. Information about food that is TCS animal food, and about the appropriate temperatures to address the potential for microorganisms of animal or human health significance to grow or produce toxin, in food are well-established in the scientific literature. Documents prepared by or on behalf of FDA regarding appropriate time/temperature controls for safety (Refs. 86 and 87) provide numerous references to the primary scientific literature and serve as the basis for time/temperature controls for a variety of foods including animal food. The two temperatures commonly cited in these documents as maximum temperatures for safe storage of refrigerated food are 41 [degrees] F (5 [degrees] C) and 45 [degrees] F (7 [degrees] C). The cited maximum temperature depends on the type of food; in some cases, a maximum storage temperature is established through rulemaking in a regulation. For example:
* FDA regulations for the prevention of Salmonella Enteritidis in shell eggs during production, storage, and transportation ( SEC 118.4(e) (21 CFR 118.4(e))) and for refrigeration of shell eggs held for retail distribution (21 CFR 115.50(b)(2)) require that eggs be held and transported at a temperature not to exceed 45 [degrees] F (7 [degrees] C).
* The PMO provides for pasteurized Grade "A" milk and milk products to be held at 45 [degrees] F (7 [degrees] C) (Ref. 77).
* The FDA Food Code, which has been widely adopted in state laws, recommends holding most potentially hazardous (TCS) food at 41 [degrees] F (7 [degrees] C) or lower (Ref. 88).
Storage of refrigerated food at or below one of these two temperatures (i.e., 41 [degrees] F (5 [degrees] C) or 45 [degrees] F (7 [degrees] C)) consistent with storage temperatures required by regulation or recommended in widely adopted documents such as the PMO and the FDA Food Code would satisfy proposed SEC 507.48(a).
The Agency considers frozen animal food to be a subset of refrigerated animal food. The temperature and time required for a frozen animal food to become unsafe would result in significant quality issues for such food. Although there have been occasional problems with frozen animal food being subject to temperatures that allow some thawing in storage and distribution, the Agency is not aware of situations in which frozen animal food has been associated with the food becoming unsafe. Thus, the Agency tentatively concludes that it would be rare for an unexposed frozen packaged animal food to be a TCS animal food.
Proposed SEC 507.48(a)(2) would require that the owner, operator, or agent in charge of a facility solely engaged in the storage of unexposed packaged animal food monitor the temperature controls established for unexposed refrigerated packaged TCS animal food with sufficient frequency to provide assurance that they are consistently performed. Monitoring can be done by use of a continuous temperature-recording device (e.g., a recording thermometer) that indicates and records the temperature accurately within the refrigeration compartment with a visual check of the recorded data at least once per day. Monitoring as would be required by proposed SEC 507.48(a)(2) would provide the owner, operator, or agent in charge of the facility with factual information with which to judge whether the temperature control is operating as intended. Proposed SEC 507.48(a)(2) is modified relative to the analogous monitoring requirement that would be established in proposed SEC 507.39(a) in subpart C in that proposed SEC 507.48(a)(2) would not require written procedures for monitoring. The records of monitoring (which would be required by proposed SEC 507.48(a)(5)(i)) would demonstrate the frequency of monitoring. The Agency requests comment on whether there would be a benefit to requiring a facility to develop written procedures for monitoring temperature.
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