FSMA Preventive Controls: What’s the Difference between Humans and Animals?

    Posted by Chelsey Davis on Mar 4, 2016 4:38:06 PM

    FSMA Preventive Controls: Difference Between Animals and Humans

    In our Chill Out About FSMA post, we talked about how similar the Food Safety Modernization Act (FSMA) rules are when you break them down into digestable sections. And for the most part the Preventive Controls for Human Food rule and the Preventive Controls for Animal Food rule are very similar in design. For example, you will still be required to create a food safety plan with identifying and controlling hazards as the core activity, but there are a few key differences between the two.

    For example, if you’re developing a human drug and an animal drug, it’s going to be slightly easier to identify hazards on the human side because you’re dealing with one species—a human.


    But when you’re dealing with an animal drug, you’re dealing with the animal kingdom. What species are you going to be developing this drug for? Are you going to have a feed additive that’s used solely for poultry? Or will it be used for companion animals? The species part of the hazard analysis gives you a multiplicity of hazards. Not only do you have to account for salmonella, but you have to know, for example, how salmonella is different in swine as opposed to poultry. Your hazard will need to be specific to the species, and will not be generalized.

    Certain hazards are unique to certain species. And when looking at the hazards, the risks may be different. For example, one animal may not react the same way to a particular hazard, so you may have to control it in a different way. Or a certain species may make the hazard more likely to occur. This is what will make the animal food safety plans and analysis different.


    Here’s an example where the risk is different. When you look at the hazard, you would have a different outcome based on the risk for one particular species than what you would for another.

    Take corn as an example. The potential hazard here is aflatoxin with con in animal feed. If the corn is fed to dairy cows, how will the hazard analysis then play out? You’ll have to look at risks for the animal and risks associated with the amount of aflatoxin potentially in the milk. Is there going to be a large amount in the milk? If so, to what level? How do you control for that risk?

    If you do the same analysis, but change the species to swine, does swine respond to corn the same way the cow does? There are differences in size, weight, consumption, digestion, so the risk level may vary. One species is for milk production, while the other is for meat production.

    Same risk. Same hazard. But because the species has changed, you’ll have a new risk analysis and could potentially have a different control for the same hazard. This is another illustration as to how this food safety plan will be different to the human controls food safety plan.

    Animals are Unique

    There are a few particular items unique to a food safety plan on the animal side versus the human side, and some items were omitted altogether. One item added is the consideration of hazards that could occur to human handlers. This is largely going to play out in the companion animal side, but you could also be in animal production and looking at the animal feed.


    Another difference is the subject of nutrition imbalances. Animal welfare is an undercurrent to this rule, so you not only have to worry about making sure the human handler is safe, but you also need to make sure the product produced from the animal and the animal overall is safe. In a lot of these situations, this is the animal's primary or sole form of nutrition, so you want to make sure that the nutrition is properly balanced and that the hazard is controlled.

    And if this is a facility operation where you’re adding feed additives for production, you want to make sure that the chemical additives you’re adding to the feed are at the appropriate levels for animal welfare. Worrying about nutrition is not something you necessarily see on the human side, but is something you need to account for in the animal controls food safety plan.

    One of the things the animal food rule doesn’t account for in food safety plans are allergens. Allergens are uniquely a human hazard. The regulations the FDA has on allergen controls only apply to humans.

    Additionally, as with the human food rule, when you’re talking about the food safety plan, you’ll need to have a preventive controls qualified individual involved throughout the process. You can read more about unraveling the Preventive Controls Qualified Individual Requirement here.

    If you're looking to understand who is covered by FSMA's Preventive Controls for Animal Food rule, take at look at our post, Preventative Controls for Animal Food: Who Is Covered?

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