Breaking New Ground In Use of Intentional Genomic Alterations In Cattle Candace Smith & Lindsay Burley Steptoe & Johnson, PLLC The Food and Drug Administration’s (“FDA”) Center for Veterinary Medicine provides oversight for Intentional Genomic Alterations (“IGAs”) in animals. This oversight includes a risk-based evaluation that is particularly focused on safety. In most cases, IGA developers are required to obtain an approved application for IGAs in animals prior to marketing. However, for low-risk IGAs, the FDA can use its enforcement discretion to waive such approval. Essentially, this enforcement discretion allows the FDA to determine, following a risk-based review, that a product is low-risk to humans, animals, and the environment, such that no application is required to be submitted for approval. Historically, the FDA has utilized its enforcement discretion over animals that are not intended for food use. For example, the FDA has approved IGAs in aquarium fish intended to cause the fish to fluoresce and in animals of food-producing species intended for use as models of disease. Recently, however, the FDA made a low-risk determination for the marketing of IGAs in food products. A developer submitted genomic data for the FDA’s consideration of an IGA to be used in cattle to create a very short, slick-hair coat. The cattle with this IGA are known as “PRLR-SLICK” cattle. This same short, slick-hair coat can sometimes be found in conventionally bred cattle due to naturally occurring mutations. Studies have shown that cattle with this short, slick-hair coat may be able to better withstand hot weather, which could in turn, help prevent the cattle from experiencing temperature-related stress and lead to better food production. In addition to showing that this same trait can occur naturally, the data submitted by the developer also showed that the food from PRLR-SLICK cattle is the same as the food produced from conventionally bred cattle that have the same short, slick-hair coat. Based on these factors and the data submitted, the FDA determined that the IGA for PRLR-SLICK cattle is low risk and does not raise any safety concerns. Therefore, the FDA exercised its enforcement discretion and decided that the developer does not have to obtain FDA’s approval prior to marketing. The developer anticipates that meat products derived from cattle with this IGA will be available for purchase by the general population in as early as two years.
These materials are public information and have been prepared solely for educational purposes. These materials reflect only the personal views of the authors and are not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and Steptoe & Johnson PLLC cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the authors or Steptoe & Johnson PLLC. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 18 • Cow Country • May
This low-risk determination is significant in a number of ways. The low-risk determination helps the developer because the developer will not have to seek the FDA’s approval once again before it markets the beef from these cattle. The low-risk determination also, however, helps other cattle breeders who want to raise and produce cattle with the short, slick-hair coat trait. The IGA that created the PRLR-SLICK can be passed on to offspring, meaning that the trait can be shared through conventional breeding. Therefore, the FDA does not expect other farms or facilities (i.e., farms and facilities owned by someone other than the developer) that are producing and breeding these low-risk PRLR-SLICK cattle using conventional breeding techniques to register with the FDA. Not only does this low-risk determination allow other cattle breeders to breed cows that would better withstand heat, but the determination could also encourage other developers to bring new IGAs forward for the FDA’s risk determination. An attorney can help you stay apprised about emerging IGA-related breeding opportunities and ensure you have satisfied any FDA requirements associated with the newly-developed breeds of cattle.
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Saturday, May 21, 2022 12:00 Noon Central Time
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