* The formulation of the animal food;
* The condition, function, and design of the facility and equipment;
* Raw materials and ingredients;
* Transportation practices;
* Manufacturing/processing procedures;
* Packaging activities and labeling activities;
* Storage and distribution;
* Intended or reasonably foreseeable use;
* Sanitation, including employee hygiene; and
* Any other relevant factors.
The Agency tentatively concludes that these are factors that a prudent person who manufactures, processes, packs, or holds animal food would consider when evaluating identified hazards to determine whether they are reasonably likely to occur. As the Agency indicated when proposing FDA's HACCP regulation for juice, a prudent processor should consider factors such as these in doing a hazard analysis (63 FR 20450 at 20468,
Proposed SEC 507.33(d)(1) would require that the hazard evaluation consider the formulation of the animal food. The addition of certain ingredients such as acids and preservatives may be critical to the safety of the food, since they may inhibit growth of, or even kill, microorganisms of animal and health significance. This could impact the evaluation of the potential for growth of pathogens in the animal food during manufacturing, processing, packing or holding. A multi-component food may have individual ingredients that on their own do not support growth of undesirable microorganisms, e.g., because of their oil content or salt content that affects aw, but when these ingredients are combined the finished food may have an aw that supports microorganism growth. Under proposed SEC 507.33(d)(1), the interaction of the individual ingredients must be evaluated as part of the formulation of the animal food.
Proposed SEC 507.33(d)(2) would require that the hazard evaluation consider the condition, function, and design of the facility and equipment. The condition, function, or design of a facility or its equipment could potentially result in the introduction of hazards into animal food. For example, older equipment (e.g., older belt, bucket elevator, or auger conveying equipment) may be more difficult to clean (e.g., with close fitting components or hollow parts) and, thus, provide more opportunities for pathogens to become established in a niche environment than modern equipment designed to address the problem of pathogen proliferation in niche environments. Proposed SEC 507.33(d)(2) would require that facilities with such equipment consider the impact of the equipment on the potential for a pathogen to be a hazard that is reasonably likely to occur; in those situations, a preventive control such as enhanced sanitation controls may be appropriate, particularly if the equipment is used in production of animal food products that would not undergo further processing to eliminate pathogens prior to consumption. Equipment designed such that there is metal-to-metal contact may generate metal fragments. Proposed SEC 507.33(d)(2) would require that facilities with such equipment consider the impact of the equipment on the potential for generation of such metal fragments to be a hazard that is reasonably likely to occur; if so, a preventive control such as metal detectors may be appropriate.
Proposed SEC 507.33(d)(3) would require that the hazard evaluation consider the effect of raw materials and ingredients on the safety of the finished animal food. While there is an overlap between raw materials and ingredients, not all raw materials are ingredients. Before being used in the manufacturing process, raw materials are often altered to be used in different processes. For example, molasses, a thick, dark syrup, is a byproduct of sugar refining that is used as an ingredient in animal food for cattle. Briefly, to make molasses from sugar cane, washed cane stalks are shredded into short pieces and cane juice separated from the stalks by mechanical (pressing through rollers) or solvent (water or lime juice) extraction methods. The juice is then subjected to a series of processes including filtration, vacuum boiling, and centrifugation to clarify the juice, crystallize out, and separate the sugar leaving the thick syrup (molasses). Because the production process transforms sugar cane stalks, the raw materials, into molasses, those raw materials generally would not be viewed as "ingredients" of the final product, molasses. Likewise, if a facility that manufactures animal food for cattle mixes molasses with other food products to make the food, the facility would view molasses as an ingredient of its cattle food product, but would not view the sugar cane stalks used to produce molasses as ingredients of its cattle food product. Animal food can become contaminated through the use of contaminated raw materials or ingredients. For example, corn grown under severely hot and dry weather conditions often becomes infected with Aspergillus flavus. Under these environmental conditions, this fungus is likely to produce aflatoxins, resulting in aflatoxin contaminated corn. Corn is one of the most frequently used ingredients in animal food, and corn contaminated with aflatoxins can cause illness in animals consuming food made with the corn and in humans consuming milk derived from dairy cattle consuming food made with the contaminated corn (Refs. 71 and 53).
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