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FSMA Preventive Controls: Humans vs. Animals

Denis Storey
February 6, 2020

On Demand Webinar: Food Regulations 101

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On Demand Webinar: Food Regulations 101

FDA attorney Marc Sanchez discusses the primary regulatory agencies in the United States, what’s regulated and why, sources of law, and practical suggestions to put that regulatory knowledge into practice.

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The Food Safety Modernization Act (FSMA) establishes preventive controls for the manufacturing, processing, packing, and storing of both human and animal foods. Separate rules outline the key requirements for each, and differences do exist. For many companies, the line of delineation is relatively simple. Are you producing human food or animal food? For others, especially companies that produce byproducts consumed by animals, the answer isn't so clear.  

One vs. Many Species

Both the human and animal rules require the creation of a food safety plan with adherence to Good Manufacturing Practices (GMPs) and preventive controls. Differences exist because the regulations must consider the species in question. For example, in the development of a food additive, identifying hazards for the human species is relatively simple, as we're only one species. In the development of a similar additive for animals, there are nine to ten million animal species within the animal kingdom, so identifying the single species (or a subset of species) you want to target is very important. In the human food rule, hazard analysis pertains to only the human species. In the animal rule, companies must account for the differences in, for example, salmonella found in poultry, versus salmonella found in swine, and prepare appropriate hazard analysis for each. This consideration increases hazard analysis complexity in the animal rule because hazard analysis is specific to the species. 

Animal Hazards and Risks

Some hazards are unique to certain animal species. Depending on the species, the associated risks involved may also differ. Individual species can react differently to hazards, and some hazards are more likely to occur in one species over another. Each permutation requires separate controls, and that equates to complexity within the safety plan supporting animal foods.

Concerning risk, the different outcomes associated with a given hazard, also differ among species. For example, animal feed containing corn holds a potential aflatoxin hazard. If dairy cows consume the feed, the hazard analysis will include risk to the animal and the milk produced. What level of aflatoxin will occur in the milk, and how will the risk be controlled? 

If the same analysis occurs in swine, will a swine respond to the corn similarly to dairy cows? These animals have different sizes, weights, consumption points, and digestion processes, and these variables create a significant risk potential for different animals. In this example, we have the same risks and the same hazards. However, the risk analysis will contain different controls for the same hazard across species, because of the difference in species. 

Animals are Unique

Three items make the animal food safety plan unique:

  1. Human Handlers – Hazard analysis must account for hazards and risks reasonably likely to occur to human handlers.

  2. Nutrition Imbalances – Animal welfare depends upon appropriate levels of feed additives and nutrition. 

  3. Allergens – The animal food rule does not account for allergens, as allergens are uniquely a human hazard.  

Find additional insights on FSMA basics in our on demand webinar, "Food Regulations 101." Watch the recording here