Section VII discusses the Agency's approach to the requirement in FSMA section 103(c) for a science-based risk analysis of the types of on-farm manufacturing, processing, packing, or holding operations that can involve animal food that is not consumed on that farm or on another farm under common ownership for purposes of section 415 of the FD&C Act and request comment on that approach. The final approach will consider comments received to this proposed rule.
Section VIII.C discusses proposed exemptions for small and very small businesses that are solely engaged in certain types of "low risk" activities involving the on-farm manufacturing, processing, packing, and holding of certain "low risk" animal foods from the requirements of section 418 of the FD&C Act (proposed
e. Exemption or modification of requirements for certain facilities. Under section 418(m) of the FD&C Act, the Secretary may exempt or modify the requirements for compliance of section 418 of the FD&C Act for hazard analysis and preventive controls for facilities that are solely engaged in the storage of raw agricultural commodities (RACs) (other than fruits and vegetables) intended for further distribution or processing. As discussed in section VIII.C, in accordance with the discretionary language of section 418(m),
Section 418(m) of the FD&C Act also authorizes the Secretary to exempt or modify the requirements for compliance with section 418 for facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment. Section VIII.E describes the proposal for how the requirements of proposed part 507 would apply to such facilities that store animal food (proposed
FDA proposes to implement section 103 of FSMA in several regulations, rather than a single regulation that covers all food and hazards subject to preventive controls. This proposal is applicable to certain hazards that may be associated with a food facility that manufactures, processes, packs or holds animal food. Section 103 of FSMA applies to "food," which is not limited to human food. Section 201(f) of the FD&C Act defines "food" to include "articles used for food or drink for man or other animals."
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