The Food Safety Modernization Act (FSMA), and its new requirements, has been discussed at length in the food industry in recent years. However there is one aspect of these new regulations that is still not widely known by many we talk with: the new requirements for human food by-products that are used for animal feed. We have received a number of questions about these new requirements, and thought it would be a good topic for a newsletter article to help clarify what FDA expects to see. Draft guidance was released by FDA in early September (just a few weeks ago) which attempts to provide some clarity on the issue, but in true FDA fashion it is written in very general terms and still leaves many questions unanswered. In this article we have laid out the details that we do have available, to help shed some light on these requirements for our readers.
Why The New Requirements?
The FDA has recognized that there’s an important place for human food by-products that are perfectly safe to consume, but may not be suitable for sale as human food because they don’t meet consumer’s expectations, or they don’t meet quality criteria, or they aren’t typically consumed by people. But they also understand that these products, if contaminated, can be harmful to the animals – and also to humans later. As an example of the need for these new regulations, they point to past incidents of dioxins in animal feed building up in animal tissue and later making its way into the food supply and making people ill. Other toxins can also potentially begin to build up in animal tissues. Additionally, pathogens such as harmful bacteria, if consumed by animals, can be found living in their gut later and can easily spread to other animals as well as making their way into the human food supply.
In General Terms
First, it’s important to understand what sort of products FDA is referring to when they talk about “human food by-products used for animal feed”. Their recent guidance document gives some good examples, as shown in the image below. As you can see, it’s relatively straight-forward (From page 5, “Draft Guidance for Industry #239”):
Some examples of human food by-products used for animal food include:
- Wheat middlings generated while processing wheat for flour.
- Grain products (hulls, bran, germ, gluten meal, grits and meals) from other grain processing operations.
- Peels, rinds, pomace, pulp, culls, or other similar material generated from processing fruits or vegetables for human consumption.
- Human food such as potato chips, cookies, bread, pastry products, and pasta that is not adulterated and is safe for use as animal food, but is not acceptable as human food for quality reasons such as the wrong size, shape, color, or texture.
This would include things like almond hulls, pomace (solids) from wine, juice, or concentrate production, and other similar items if sent to animal feed.
Now let’s take a look at some of the guiding principles that the regulations put into place. The products have to be “safe for their intended use”, and cannot be adulterated, or misbranded – these are the same criteria that human food products must meet. That is, if it’s unsafe for human consumption, it’s not ok to simply redirect it to animal feed; any by-products directed to animal feed must be safe for consumption. In addition to the by-products themselves, any processing aids or additives present in the products should meet GRAS status (Generally Recognized As Safe), or be approved as an additive for animal feed. Some food companies will need to implement a decision-making process, if not already in place, to determine whether or not waste streams are suitable for animal feed.
Again, as indicated above, FDA’s main concern during holding of human food by-products that will become animal feed is that they be protected from harmful contaminants. In the Preventive Controls regulation, in section L, they discuss in very general terms that the any holding containers or product conveyances (conveyor belts, bucket elevators, etc.) be made of suitable materials, be cleaned as necessary, and be maintained in a way that prevents contamination (preventive maintenance). They specifically mention separation of these by-products from trash to prevent contamination. The regulation also requires that containers for shipping be inspected prior to use to ensure they are clean and won’t contaminate these products.
The regulations also stress the importance of accurate labeling, so that food products, by products, and trash be clearly discernible as separate items so that they are not mishandled and there is no cross-contamination. A specific requirement laid out in the regulation is that by-products be labeled with their common name. One recommendation found in the guidance is color coding of containers, which makes a lot of sense and is already in place at many of our customers’ facilities.
Something interesting found in the guidance document is the new expectation that food companies be intentional about what happens to their by-products after they’re sold. We see a new expectation that these by-products, if they aren’t safe for consumption, should be labeled as “Not For Animal Food Use”. This is similar to some of the new supply chain requirements found in the regulations, which require food processors to communicate with their customers regarding further processing of their food products that may be necessary to make it safe, such as pasteurization. So we’re seeing an expectation of greater due diligence on the part of food companies with what happens to their products after they’re shipped, both with their primary food products as well as by-products.
The FDA does lay out some specific allowable defect levels for contaminants in animal feed that are unavoidable; for instance, aflatoxin. There are allowable levels of this compound that the FDA considers acceptable for human food as well as animal food, and the regulations are specific to what the purpose of the feed is. Some details can be found in “Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed” Keep in mind that this is a guidance document, and is not all-inclusive. There are also Compliance Policy Guides in place that can be referred to for guidance for human food, which may provide some additional guidance. If you have any more specific questions please reach out to us, as our labs can help with product testing and our team will do our best to help answer any questions.
- Draft Guidance for Industry #239: Human Food By-Products for Use as Animal Food
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule (see section L, page 214)
- Draft Guidance #235: Current Good Manufacturing Practice Requirements for Food for Animals