Animal Food Rule 21 CFR 507

The sub parts of this rule that you need to comply with are based on the activities you perform in your business:

• Manufacturing – if you are manufacturing feed or feed ingredients you must be in full compliance with FSMA. In reality, if you manufacture, you are probably also processing raw materials and you certainly package them either in bag or bulk for sale.
• Processing – There may be some facilities who do not manufacture finished feed or feed ingredients but process raw ingredients such as drying, cracking or grinding corn or crimping oats. These activities also require full compliance with FSMA.
• Packing – If a facility only buys bulk feed or ingredients and packages it for further distribution, this activity also requires full compliance with FSMA.
• Holding – If a facility only buys feed or ingredients and holds it in a warehouse for further distribution, much like CFD and a retail store, this activity requires limited compliance with FSMA.

What does full compliance and limited compliance require?

 

Sub Part	Title	Manufacture / Process / Pack	Hold	BY
A	General Provisions (training)	YES	YES	9/17/17
B	Current Good Manufacturing Practice	YES	YES	9/17/17
C	Hazard Analysis and Risk- Based Preventive Controls	YES	NO	9/17/18
D	Withdrawal of a Qualified Facility Exemption	NA	NA	NA
E	Supply Chain Program	YES	NO	9/17/18
F	Records (as they apply to above)	YES	YES	As above

Sub Part B – cGMP’s – there is eight categories of cGMP’s that are considered to be necessary to the manufacture of safe animal feed. These are the foundation from which everything is built upon. This is where you start to: “say what you do and do what you say”.

In order to gain compliance with FSMA you should consider writing standard operating procedures (SOP’s) that demonstrate or document your compliance with cGMP’s.

1. Personnel – defines employee rules regarding hygiene and sanitation.
2. Plant and Grounds – maintenance of your facility and pest control.
3. Sanitation – housekeeping procedures and the handling of toxic materials required to maintain sanitary conditions.
4. Water Supply and Plumbing – water, plumbing, sewage and trash disposal procedures.
5. Equipment and Utensils – procedures for the cleaning and repair of equipment, calibration of equipment.
6. Plant Operations – includes purchasing, receiving, storage, processing and manufacturing.
7. Holding and Distribution – includes packing, storing and shipping.
8. Holding and Distribution of human food by-products for use in animal feed – process definition from packing, storing and shipping specific to human food by-products.