Animal food companies other than small and very small businesses were required to implement the new CGMPs in September 2016. On September 18, 2017 these same large businesses are required to implement the preventive controls portion of the regulation. Also on this date, small businesses with fewer than 500 full-time employees are required to implement the CGMPs as written in the regulation. These small businesses will have an additional year to implement the preventive controls which are required September 2018.
The CGMPs and preventive controls compliance dates for animal food were staggered because these requirements are new for this type of food product. This is the first time this kind of comprehensive preventive oversight has been in place and CGMPs for animal food did not exist in the entirety that were available for human food. When the proposed rule was sent out for comments, the industry requested that the compliance dates be staggered to allow a year to focus solely on CGMPs as they are the foundation that must be in place before preventive controls are established.
What is the difference between CGMPs and preventive controls?
CGMPs are the foundation of food safety. They’re the best practices required in the normal course of business, like cleaning, sanitation, pest management, equipment maintenance, and personal hygiene. CGMPs establish a foundation to produce safe animal food. Preventive controls require further development of the food safety plan with a complete hazard analysis focusing on issues that, if found in animal food, could be a public health concern. The analysis requires consideration of potential biological, chemical, and physical hazards and the steps needed to reduce or minimize associated risks.
Increased FDA oversight of CGMPs is resulting in more routine inspections. Large companies with more than 500 full-time employees are required to meet the preventive controls requirements in the fall of 2018. FDA has repeatedly stated that they want to educate before they regulate, which is the reason for the delay of inspections.
However, we want to issue a word of caution. Just last week, FDA indicated that although these rules will not be inspected for compliance until the fall of 2018, if there is a problem with a potential or actual food safety hazard FDA inspectors will use the tools available to them to keep that food out of the marketplace. This is important to understand!
FDA’s newest Draft Guidance for Industry #239: Human Food By-Products for Use as Animal Food is available now. So if you are a human food facility that holds food for animal feed these are the requirements and guidance you should follow.