Livestock Health Care vs. Feed Ingredients

How does OMRI differentiate between livestock feed ingredients (LF) and livestock health care (LH) products, and thus decide which review policies to use?

By Nick Stansbury

The National Organic Program (NOP) regulations at 7 CFR Part 205 outline distinct standards for Livestock Feed at §205.237 and Livestock Health Care at §205.238. There is some overlap, and §205.238 includes the “[p]rovision of a feed ration sufficient to meet nutritional requirements” as a health care practice standard. Crucial to the review of products in both classes is the distinction between synthetic/nonsynthetic and agricultural/nonagricultural status of the ingredients. Beyond that similarity there are some clear differences.

OMRI differentiates an LF versus an LH product using the product label. The label for a product applying to the LH class must indicate a compliant health care use (e.g., non-routine use, administered at certain stages of life, prescriptive). These products include animal drugs, general use health care substances, internal and topical medications and biologics. The label for a product applying to the LF class does not have to include use instructions, but if it does, they must be consistent with use as an additive or supplement for livestock feed. Examples include, but are not limited to, a Guaranteed Analysis showing protein, fat and fiber; instructions to mix with other feed; or directions indicating quantities to be used per an amount of feed. LF products can be further segmented by whether the label indicates it is a feed additive or feed supplement. The National List allows a limited number of synthetic substances in a feed additive, but provides no allowance for synthetic substances in a feed supplement. A feed additive is a substance or combination of substances added to the basic feed mix to fulfill a specific nutritional need, normally in micro-quantities. A feed supplement is used along with another feed to improve the nutrient balance or performance of the total feed ration. It may be fed undiluted as a supplement to other feeds, or offered free choice with other parts of the ration being separately available.

For an LF product, agricultural ingredients identified in an ingredient list must be organically produced or handled, and all nonagricultural ingredients must be nonsynthetic, or synthetics appearing at §205.603(d). For LH products, agricultural ingredients do not need to be organically produced or handled, and OMRI also distinguishes between active ingredients and excipients. Active ingredients must be nonsynthetic or synthetics appearing at §205.603 for the intended purpose. Excipients are ingredients intentionally added to livestock medications (i.e., LH products) that do not exert therapeutic or diagnostic effects at the intended dosage, but may improve product delivery. Excipients must be nonsynthetic, or synthetics allowed under §205.603(f). Excipients identified by the FDA as Generally Recognized as Safe or approved by the FDA as a food additive are allowed in LH products. If an LH product is registered under a New Animal Drug Application or New Drug Application, or is APHIS registered, OMRI considers any excipients present in those products allowed in organic production.

Revised and updated in March 2020 by OMRI Technical Director Doug Currier. This article was originally published in the Winter 2017 edition of the OMRI Materials Review newsletter.