3. Proposed SEC 507.48--Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Packaged Animal Food That Is Not Exposed to the Environment
Proposed SEC 507.48(a) would require that the owner, operator, or agent in charge of a facility solely engaged in the storage of packaged animal food that is not exposed to the environment conduct certain activities for any such refrigerated packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of animal or human health significance. Briefly, those activities would encompass:
* Establishing and implementing temperature controls (proposed SEC 507.48(a)(1));
* Monitoring the temperature controls (proposed SEC 507.48(a)(2));
* If there is a problem with the temperature controls for such refrigerated packaged animal food, taking appropriate corrective actions (proposed SEC 507.48(a)(3));
* Verifying that temperature controls are consistently implemented (proposed SEC 507.48(a)(4)); and
* Establishing and maintaining certain records (proposed SEC 507.48(a)(5)).
More specifically, proposed SEC 507.48(a)(1) would require that the owner, operator, or agent in charge of a facility subject to proposed SEC 507.48 establish and implement temperature controls adequate to significantly minimize or prevent the growth of, or toxin production by, microorganisms of animal or human health significance in an unexposed refrigerated packaged TCS animal food. There are two fundamental questions that the owner, operator, or agent in charge of a facility subject to proposed SEC 507.48 would need to know the answers to in order to comply with proposed SEC 507.48 for any given unexposed refrigerated packaged animal food:
* Is the animal food a TCS food?
* If the animal food is a TCS food, what is the appropriate temperature for storage of the food?
The two primary ways in which the owner, operator, or agent in charge of a facility subject to proposed SEC 507.48 can obtain the answers to these questions are through: (1) Information provided by the manufacturer, processor, or packer of the animal food, either in documents exchanged between the parties in the course of business or by label statements placed on the animal food by the manufacturer, processor, or packer of the food and (2) applicable scientific and technical support literature.
As discussed in section VIII.E, a citizen petition submitted to FDA (Docket No. FDA-2011-P-0561) asserted that facilities work closely with the food manufacturers to understand the conditions and controls that need to be utilized to ensure the quality of the foods they store and distribute and, in many cases, those conditions and controls are formalized in written contracts. If the conditions for storage are not formalized in written contracts or by other means (e.g., through documents of the trade that travel with a food product when it moves within the supply chain), information relevant to safe storage of the food may be provided by the manufacturer, processor, or packer of the food on the food label. For example, in 1997 FDA published guidelines for labeling food that needs refrigeration by consumers due to the potential for the food to be rendered unsafe due to the growth of infectious or toxigenic microorganisms if "temperature abused" (62 FR 8248). FDA recommended that foods requiring refrigeration by the consumer for safety be labeled "IMPORTANT Must be Kept Refrigerated to Maintain Safety" (62 FR 8248 at 8251) and that foods that are intended to be refrigerated but that do not pose a safety hazard if temperature abused be labeled more simply, e.g.; "Keep refrigerated." Such labeling can provide facilities with the information to identify TCS animal food. The Agency tentatively concludes that similar food safety principles applied in human food storage would be relevant to animal food. Further, the Agency tentatively concludes that it would be rare for a facility solely engaged in the storage of unexposed packaged animal food to not have information regarding whether a refrigerated packaged food requires time/temperature control for safety and, if so, what specific temperature controls are necessary for safe storage of the food. The Agency requests comment on this tentative conclusion.
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