The FSMA rules for human and animal food are quite similar. However, it is important to understand that there are two different GMPs: Part 117, Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Controls for Human Food (HARPC); and Part 507, Current Good Manufacturing Practice (HARPC) for Animal Food, for the preventive controls rules. Is it possible that a food company could come under both rules? The answer is yes, but there are some distinctions you need to be aware of.
If you are operating under Part 117 (human food) and are in compliance with those GMPs, you don’t have to apply Part 507 (animal food) requirements as long as you are not processing those by-products to make an ingredient or an animal food. However, you will still have to ensure that the by-products are not contaminated by doing the following as defined in § 507.28
- Proper storage conditions that prevent contamination of by-products
- Containers and equipment are properly designed and constructed of materials that will prevent contamination
- Protected against any contamination with trash or other objectionable materials
- The by-products must be properly labeled, e.g. identified by a common name
- Shipping containers including the actual vehicles used for transport must be inspected prior to use whether they are the facility’s containers and transports or a contracted 3rd party handling and delivering those by-products
If you are a human food processor and you are doing further processing of your by-products such as dehydrating product, pelletizing the product, adding enrichment to make an ingredient or final animal food product, you do come under the animal food rule in Part 507 and both sets of GMPs apply to you.
For more information on how the seven FSMA rules apply to your company, visit our website for FDA-recognized training for Preventive Control Qualified Individual(s), webinars, FSMA regional courses, and 5 Easy Steps to a FSMA Ready Facility.