1. Can you clarify how FDA defines “cattle managed in a dry lot”?
Growing Beef Steers and Heifers in a Dry Lot: Weaned growing beef steers and heifers (beef and dairy breeds) maintained in a dry lot. They receive the majority of their diet from harvested forage (possibly with a supplement).
FDA considers dry lot management to mean beef cattle that receive harvested forages as the majority of their diet and are reared on dormant pastures with insufficient biomass to sustain typical growth and/or housed in dirt floor pens. Beef cattle in this production phase may receive minimal supplementation (generally a protein supplement) to achieve growth rates consistent with those typically observed in cattle on pasture. Cattle in this production phase may move next to a pasture management setting or to a feedlot management setting.
Cattle producers should note that there are currently no cattle ear implants approved for use in a reimplantation program for this production phase of beef cattle.
2. How are products labeled if they are approved for use in more than production phase or class (or subclasses or variants) of animals?
Appendix III of GFI #191 lists the umbrella target animal class under which numerous other classes, subclasses, and variants are listed or “nested”. In general, when FDA approves a new animal drug product, the labeling lists the approved target animal class(es) at the most restrictive level based on the conditions of use in the regulatory studies used to support approval. When a product is approved for use in a higher order class (e.g., Beef Cattle), the nested or subclasses do not appear on the labeling. Below are some examples of how products may be labeled and how they may be used.
A product is labeled as approved for use in “Beef Cattle”. Per Appendix III, there are five specific subclasses of Beef Cattle (Beef Calves, Beef Steers, Beef Heifers, Beef Bulls, and Beef Cows) which may have additional variants or subsets listed. A product approved for use in “Beef Cattle” may be used in all five subclasses, including any variants or subsets listed in the subclasses. However, these subclasses/variants/subsets are not enumerated on the labeling.
A product that is approved for use in “Beef Steers” would permit use in all three variants of beef steers listed in the Appendix [i.e., growing beef steers on pasture, growing beef steers in a dry lot, and growing beef steers fed in confinement for slaughter (which includes those cattle in a grow yard)], and those variants would not appear on the labeling.
A product that is approved for use in Growing Beef Steers Fed in Confinement for Slaughter may be used ONLY in that specific variant, which includes Growing Beef Steers in a Grow Yard, as those cattle are considered a subset or subpopulation of Growing Beef Steers Fed in Confinement for Slaughter.
A product that is approved for use in multiple subclasses of beef cattle will specify on labeling the target animal subclasses and the associated indications. An example of the labeled indications for an implant that is approved for use in more than one subclass would state: “For increased rate of weight gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and for increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter.” The implant may only be used in those four classes of animals: in growing beef steers on pasture, growing beef heifers on pasture, growing beef steers fed in confinement for slaughter, and growing beef heifers fed in confinement for slaughter.
3. What if I am uncertain which implant(s) can be used in a reimplantation program?
4. What if I have cattle on July 1 that have received more than one implant in a production phase, and the implants used were not approved for use in a reimplantation program? Will my cattle be considered adulterated?
Cattle that were implanted or reimplanted prior to July 1, 2023, will not be considered adulterated. Per the December 10, 2021, Letter to Industry, FDA expects that beginning July 1, 2023, producers should reimplant cattle only with cattle ear implants that are explicitly labeled for use in a reimplantation program for the specific production phase.
5. Some implants have a “Not approved for repeated implantation (reimplantation)” but the implant I want to use does not have this statement on the labeling. Can I use this implant in a reimplantation program?
Beginning July 1, 2023, you should not use an implant in a reimplantation program unless the labeling of the implant product explicitly indicates it is approved for such use. While FDA continues to work with sponsors to update their labeling to clarify reimplantation use, not all products may be updated by July 1, 2023, as FDA allows new animal drug sponsors a period of time to deplete existing inventory with older labeling. However, unless a product explicitly is approved for use in a reimplantation program (and all implants approved for reimplantation currently have these statements on the labeling), they are not to be reimplanted. FDA will publish a website listing all cattle ear implants, their approved conditions of use, and labeling status on or around July 1, 2023.