Whether you’re talking about your pet dog named Bobo or the giant feedlots with thousands of cattle you typically see while driving along in rural America, both of the food/feed supplied to these critters are now subject to the Food Safety Modernization Act (FSMA), specifically the Established Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals rule, which covers those involved in the manufacturing, processing, packing, and holding of food for animals.
What is the Preventive Controls for Food for Animals rule?
So what is the Preventive Controls for Food for Animals rule (PCAF)? It’s essentially a copy of what you’ve seen with the Preventive Controls for Human Food (PCFH) rule. If you’re familiar with that model, this rule is going to be very similar.
At its core, FSMA is adding two new functions to the animal feed and food industry. It’s adding Good Manufacturing Practices (GMPs also referred to as CGMPs for Current) and it’s building a framework for preventive controls, primarily through the food safety plan. In general, preventive controls and CGMPs are the two core mechanisms that FSMA is bringing in for the first time with this particular rule.
CGMPs are not unique on their own since they are already used in many other segments along the supply chain. They are, however, unique to the animal industry, as this will be the first time CGMPs are mandatory for animal feed and animal food producers. It’s not shocking in that it’s a novel concept, the rule is just bringing in baseline features we’ve seen before and putting them into a mandatory requirement on the animal side of things.
A Learning Curve?
What we will most likely see is something similar to what we saw on the dietary supplement side. When part 111 (GMPs for dietary supplement manufacturers, packers, holders, etc.) was introduced for the first time, there were huge spikes in violations found during audits. This resulted in a roughly 10-year adjustment period where firms, big and small, acclimated to the new environment. This acclimation might be something repeated with CGMPs on the animal side. It’s going to take some time to get these incorporated and to get audits running smoothly.
The preventive controls element to this rule is, again, very similar to the human food rule in that you still have to develop a food safety plan and conduct a hazard analysis. Once the hazards are determined, you’ll need to develop preventive controls and include the proper oversight, monitoring, and verification to adapt and revise the food safety plan over time as necessary.
One of the most common questions with regards to any FSMA rule is “Who, me?” This type of mentality, can be somewhat common throughout the supply chain. But when talking specifically about the animal food rule, if you manufacture, process, pack, or hold animal feed/food, then the rule applies to you. There is, however, one primary exemption when it comes to facilities the FDA deems a farm.
What the FDA has done is broken the term farm out into two different categories: primary production and secondary production. In general, a primary production farm is a single management facility and is largely located in the same geographic area. One could then say a secondary production farm is the opposite, meaning it’s not going to be under the same management or in the same geographical location—it’s going to be a contractual relationship.
The FDA is, however, issuing a separate guidance on what the farm definition means and how to apply it. This guidance should be coming out in the late spring.
There are also requirements as to what activities can happen on a farm to then still be considered a farm. In general, activities like pitting, roasting, or taking something like legumes and making a bean chip moves away from what the FDA feels is a farm activity and pushes more into manufacturing, processing, packing, and so forth. To be considered a farm or to be considered for exemption, you have to meet management, location, and certain activity elements.
What about Feed Mills?
Does this rule apply to feed mills? Maybe… For example, if you have a ranch and are raising beef cattle, and you have a feed mill to produce the feed to raise the beef cattle, that facility you’re using for the animal production constitutes a manufacturing, processing, or packing facility under the animal controls rule.
This then comes down to the FDA’s definition of a primary or secondary farm. If you are a primary production farm—same ranch, same geographic location, same management—then you’re producing that feed for your own animals and are not subject to the rule. But if you have broken that relationship in some way—you own the feed mill, but are not the owner of the ranch or vice versa (a contractual relationship)—then the feed mill is going to be subject to the animal food rule.
As depicted above, there are some gaps. The gaps have emerged from the statutory framework, but the FDA is talking about bringing in an additional rule that would eliminate these gaps. Basically, this additional rule would state that a feed mill producing for its own production, regardless of whether it’s primary or secondary, will need to follow at least the CGMP portion of the animal control rule. This, however, isn’t even in the proposed state yet, but rather only listed out in the comments section the FDA has issued.
What about Byproducts?
Another item to look at is byproducts like spent grain, which is a really big topic with brewers. The FDA has stated that if you produce human food, you’re going to be subject to the human food rule, but will not also be required to follow the animal food rule. So for items like spent grain, you're not going to need to follow both if that byproduct is going to feed animals.
However, the FDA has said is that if you’re taking production a little bit further and not just providing a byproduct, but are actually processing that byproduct into a finished product or performing some activity (drying, pelleting, etc.) to transform the byproduct into some other element, then the preventive controls for animal food rule is going to come in and apply to that activity. So it’s important to ask yourself:
- Do we have a byproduct?
- What are we doing with the byproduct?
- How do these rules interplay and come together?
As with all the FSMA rules, there are staggered dates of effectiveness varying for business size (small, very small, etc.) Additionally, with this particular rule, there are effective dates for just the CGMP portion and effective dates for the preventive controls portion of the rule. The CGMPs will come into effect before the preventive controls, giving a sense of priority from the FDA and also preparing you for what might take longer to develop and put into place.
Wise Words of Wisdom
If you classify as a small or very small business, use this additional prep time wisely. There are a lot of small or very small firms that will see this as an opportunity to put off certain aspects. To the contrary, the FDA has stated that facilities really do need the time allotted to develop, implement, and adopt these requirements. Use that time.
Keep this is mind
Even if you’re classified as a very small business and have extended time to comply, you still have to maintain records supporting your status as a very small business in the interim.
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