Human food by-products are not subject to the animal food rule under FSMA (except for holding and distribution) if what two things apply?

• A. Environmental health surveillance
• B. Not further processed
• C. Produced under animal food regulations
• D. Human food by-products are not subject to the animal food rule if human food is produced in compliance with human food cGMPs and all applicable food safety requirements and not further processed

Answer: (D)

Under FSMA, there is an exemption for human food by-products used as animal feed if they remain by-products and are not further processed, and they were produced following human food safety rules. The key point is that the by-product must be produced under human food cGMPs and all applicable safety requirements, and it must not undergo further processing that would change its nature. When these conditions are met, the by-product isn’t subject to the animal food rule, except for activities related to holding and distribution, which still fall under FSMA’s oversight.

This makes the correct choice: it states both essential conditions—the by-product is produced in compliance with human food cGMPs and all applicable safety requirements, and it is not further processed. The other options don’t fit because they either address unrelated concepts (environmental health surveillance), give only part of the condition (not further processed alone), or imply production under the animal food regulations (which would not be exempt).