This proposed rule would not apply to farms. For example, farms manufacturing, processing, packing, and holding food for consumption by their own animals would not be required to register under section 415 of the FD&C Act and therefore would not be required to comply with the proposed rule. However, if the farm operates an animal food manufacturing business (in addition to its traditional farm activities) that requires registration under section 415 of the FD&C Act, that food manufacturing business would likely need to comply with this proposed rule.
In complying with the Hazard Analysis and Risk-Based Preventive Controls section of the proposed rule (subpart C), facilities that manufacture, process, pack, or hold animal food for a single species of animal would focus on hazards most likely to be associated with the ingredients they use, as well as hazards most likely to occur during manufacturing, processing, packing, or holding at the facility, relevant to that species of animal. Facilities that manufacture, process, pack, or hold an ingredient would focus on reducing hazards associated with the ingredient and those species of animal that may consume animal food containing that ingredient. Facilities that manufacture, process, pack, or hold animal food for a range of species or variety of uses would need to consider a more diverse number and type of hazards. In addition to focusing on hazards associated with their incoming ingredients or the types of equipment they use, a feed mill that manufactures food for multiple species would need to be aware of nutritional sensitivities of the animals for which it makes food. For example, a manufacturer that makes food for swine, which can tolerate a relatively large amount of copper in their diet, and food for sheep, which are very sensitive to copper, would need to adopt controls that would ensure that the sheep food it does not contains levels of copper that are unsafe for sheep.
Pet foods usually contain ingredients from the same sources used to make food for livestock and pet foods are sometimes manufactured in the same facilities as food for livestock. For these reasons the Agency has not proposed different rules for these different types of facilities. However, the hazards associated with pet food may be significantly different from the risks associated with food for livestock, and the facility manufacturing, processing, packing, or holding would need to identify and address these hazards. Pet foods usually come into the home, so in addition to being safe for pets to eat, they also would need to be safe for the pet owner to handle. For example, pet foods and treats have been known to carry Salmonella (see section II.E). A facility manufacturing pet food would need to address the potential for injury or illness (including death) from the Salmonella hazard in not only animals, but in humans handling that pet food (especially the young, old, or immunocompromised.)
V. Highlights of the Proposed Rule
The proposed rule would establish part 507 and contains regulations regarding the manufacturing, processing, packing, or holding of animal food. The proposed rule would establish new provisions for CGMPs for animal food and ingredients, and it would establish new provisions for risk-based preventive controls.
Under the proposed rule, part 507 would be divided into the following subparts:
* Subpart A--General Provisions;
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