Proposed SEC 507.1(d) would apply to facilities that manufacture, process, pack, or hold animal food and human food. The Agency wanted to address the instances where a facility may handle both animal and human food in some form, to make it clear which proposed rule would apply for that facility manufacturing, processing, packing, or holding these foods. In addition, in some facilities, "waste" from human food production, such as by-products that may not be edible for humans, or lack nutritional value for humans, are used or sold for animal food. Many species of animals have different digestive systems and nutritional requirements than humans, thus allowing for this use. For the human food manufactured, processed, packed, or held, the facility would need to comply with proposed part 117 (proposed rule for preventive controls for human food (78 FR 3646)), subparts B and C as applicable (facilities subject to subpart B may not also be subject to subpart C), and as subject to the exemptions for proposed part 117. For the animal food manufactured, processed, packed, or held, the facility may choose to comply with either proposed part 507 subparts B and C as applicable or proposed part 117 subparts B and C as applicable, so long as the food safety plan also addresses all hazards that are reasonably likely to occur in the animal food, including nutrient imbalances. "Food" used in proposed part 117 would be read to include "animal food" when the facility is applying proposed part 117 to the animal food. For example, human food waste that is used for animal food would be treated as "food" for the purposes of its animal food use and as waste for the purposes of its role in human food production. The Agency tentatively concludes that this will provide facilities the flexibility to streamline their compliance efforts, while also ensuring human and animal food safety.
FDA requests comment on the applicability of the requirements of this proposed rule to
1. Definitions That FDA is Proposing
In developing the following proposed definitions,
The Agency is proposing in
Proposed SEC 507.3 defines "adequate" as that which is needed to accomplish the intended purpose in keeping with good public health practice.
FDA is proposing to define the term "affiliate" as it is defined in section 418(l)(4)(A) of the FD&C Act to mean any facility that controls, is controlled by, or is under common control with another facility. This term relates to the determination of whether a facility meets the definition of a qualified facility.
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