Nutrient imbalance hazards can result from excessive levels of a nutrient in animal food leading to toxicity (e.g., copper poisoning in sheep consuming food with excessive levels of copper), or a nutrient deficiency in the food that can compromise the health of animals (e.g., chickens fed riboflavin deficient diets experience curled toe disease) (Refs. 56, 57, 58, and 59). Nutrient imbalances are particularly problematic for animal food, because often one animal food type is the sole source of an animal's diet. A nutrient imbalance hazard in animal food would pose a greater risk to the health of animals fed a sole source diet than animals receiving multiple types of animal food (like humans eat).
Nutrient imbalance hazards can also result from diets containing essential nutrients in inappropriate proportions of essential nutrients. For example, an animal's calcium needs cannot be considered independently of phosphorus. Calcium, an essential mineral, may be adequate in forage (especially legumes) for grazing cattle. Phosphorus, however, can be deficient in the forages, and since calcium and phosphorus work hand in hand for the animal's muscle and metabolic functions, respectively, supplemental phosphorus at an appropriate level would be needed for cattle on forage-based diets. Calcium and phosphorus are also the major mineral constituents of bone. The calcium to phosphorus ratio in the animal food for cattle would need to be maintained in the desired range to prevent negative health effects associated with nutrient imbalance (e.g. rickets in young animals, osteomalacia in adult animals, reduced resistance to disease, overall reduced productivity including reduced food intake, reduced conception rates, or reduced milk production in cattle) (Refs. 60 and 61).
Proposed SEC 507.33(b)(3) would require that the hazard analysis consider physical hazards, which are required to be considered by section 418(b)(1)(A) of the FD&C Act. Examples of physical hazards include pieces of wood, stones, glass, or metal fragments that could inadvertently be introduced into animal food. Physical hazards may be associated with raw materials, especially raw agricultural products. The facility and equipment can also be a source of physical hazards (e.g., pieces of glass from glass container breakage and metal pieces such as nuts and bolts from equipment used during manufacturing/processing).
Proposed SEC 507.33(b)(4) would require that the hazard analysis consider radiological hazards. Examples of radiological hazards include radionuclides such as radium-226, radium-228, uranium, strontium-90 and iodine-131. Section 418(b)(1)(A) of the FD&C Act requires that radiological hazards be considered, and animal food may be subject to contamination with radiological hazards, e.g., if water used to manufacture the animal food contains a radionuclide.
4. Proposed SEC 507.33(c)--Hazard Evaluation
Proposed SEC 507.33(c) would require that the hazard analysis contain an evaluation of the hazards identified in SEC 507.33(b) of this section to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur. Proposed SEC 507.33(c) would implement sections 418(b)(1) and (c)(3) of the FD&C Act. Contamination of animal food with biological hazards often leads to immediate or near-term onset of illness or injury (e.g., gastrointestinal illness in humans after handling pet treats contaminated with Salmonella). Exposure to some biological hazards may have long-term consequences as well (e.g., human infections with Salmonella may lead to reactive arthritis). The health consequence of exposure to some biological hazards can be severe (e.g., acute enteritis that can cause severe abdominal pain, diarrhea or death in horses exposed to Salmonella spp. through consumption of contaminated food) (Refs. 62 and 63). Proposed SEC 507.33(c) would require that such biological hazards be considered to determine whether they are reasonably likely to occur even if the biological hazard occurs infrequently.
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