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Preventative Controls for Animal Food: Who Is Covered?

Denis Storey
February 27, 2020

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Feed supplied to livestock and the food we provide our pets is subject to the Preventive Controls for Animal Food rule within the Food Safety Modernization Act (FSMA). Thanks to the U.S. Food and Drug Administration (FDA), the manufacturing, processing, packing, and storage of animal feed and foods is regulated to keep animals safe.

What is the Preventive Controls for Food for Animals Rule?

The Preventive Controls for Food for Animals rule is a near copy of the Preventive Controls for Human Food rule. Good Manufacturing Practices (GMPs) and preventive controls are the two core components now outlined in the food safety plan.

Current Good Manufacturing Practices (CGMPs) are not unique since they exist in many other segments along the supply chain. However, they are unique to the animal industry, as this is the first time CGMPs are mandatory for animal feed and animal food producers. A balancing act, the rule elevates baseline features to a mandatory requirement to regulate animal safety.

Again, the preventive controls element to this rule is 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 establish preventive controls and include the proper oversight, monitoring, and verification to adapt and revise the food safety plan over time as necessary.

Who Does the Rule Apply To?

If you manufacture, process, pack or store animal feed/food, this rule applies to you. There is, however, one primary exemption when it comes to facilities the FDA deems a farm.

The FDA breaks the term "farm" into two different categories: primary production and secondary production. A primary production farm is a single management facility located in the same geographic area. A secondary production farm is a contractual relationship and does not exist under the same management or geographical location.

Requirements also exist as to the activities required to be considered a farm. Pitting or roasting are not considered farm activities and are considered by the FDA to relate more to manufacturing, processing, and packing operations. To be considered a farm or to be considered for exemption, you have to meet management, location, and activity elements.

What About Feed Mills?

The answer here is, "Maybe." If a company has a ranch and is raising beef cattle, and they also have a feed mill to produce the feed to raise the beef cattle, the facility used for animal production constitutes a manufacturing, processing, or packing facility under the animal controls rule.

The clarifying answer is then found in the FDA's definition of primary and secondary farms. If the company has a primary production farm operating on the same ranch, within the same geographic location, and under the same management, that feed is determined to be produced for your own animals, and the company is not subject to the rule. However, if the relationship is similar, yet the company is not the owner of the ranch, the feed mill will be subject to the Preventive Controls for Animal Food rule.

Currently, there are gaps. The FDA is considering an additional rule stating a feed mill producing for its production, regardless of whether it's primary or secondary, will need to follow at least the CGMP portion of the animal control rule. Section 5 of the Key Requirements lists this option.

What About Byproducts?

Another item of interest to many is byproducts like spent grain. If a company produces human food, they're going to be subject to the human food rule and will not also be required to follow the animal food rule. For like spent grain, companies are not going to need to follow both if that byproduct is going to feed animals.

However, if a company is 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 apply to that activity.

TraceGains has a comprehensive suite of solutions to help animal food producers maintain compliance with CGMPs while streamlining and automating business processes throughout operations. For more information, download our "Ten Components of a Strong Good Manufacturing Program" eBook here