The Commercial Feed Regulatory Program (CFRP) has released a Notice to Industry regarding the labeling and use of Bovaer®10 in commercial feed in California.
In 2023, the U.S. Food and Drug Administration (FDA) launched an Animal and Veterinary Innovation Agenda that has helped shape future direction for innovative products. California relies on FDA’s federal review and evaluation process for these new and novel products that have demonstrated progress toward climate goals. Elanco Animal Health’s Bovaer® 10 is intended for the reduction of methane emissions in lactating dairy cattle and one of the first of these innovative products that has undergone FDA review for safety and efficacy. This provides agriculture an additional tool to be part of the overall methane reduction strategy.
On October 3, CDFA’s Feed Inspection Advisory Board and its Technical Advisory Subcommittee met to discuss labeling and use of products with enforcement discretion from FDA, and specifically, Elanco’s Bovaer® 10. They reviewed and supported the CFRP’s five-step process to evaluate products/ingredients under FDA enforcement discretion for safe and effective labeling and use in California. Regarding Bovaer® 10, they reviewed information provided to CDFA’s Milk and Dairy Food Safety Branch and CFRP including the FDA Center for Veterinary Medicine enforcement discretion letter to Elanco for 3-NOP. After conducting a review of submitted information and materials, CDFA has no current objection to the sale or use of Bovaer® 10 in California, provided it adheres to California-specific labeling requirements, it is used in accordance with its labeling, and that CDFA and FDA continue to have no questions or public health concerns regarding its safety.
California’s climate goals include the reduction of methane emissions to 40% below 2013 levels by 2030, as codified in SB 1383 (Lara, 2016). CDFA’s Enteric Methane Emission Reduction Programs in the Office of Environmental Farming and Innovation are assisting the department in working towards this goal. Advancements in enteric methane reduction offer real opportunities for agricultural producers to utilize while contributing toward California’s reputation as a leader in climate-smart agriculture.