Dive Brief:
- An ingredient claiming to reduce methane emissions from dairy cattle by 30% has received approval from the Food and Drug Administration, a milestone for the agtech sector as companies race to scale solutions minimizing agriculture's environmental footprint.
- Elanco Animal Health Incorporated said Monday the FDA completed a multiyear review of the company's Bovaer feed ingredient powder, with the agency stating the supplement meets safety and efficacy requirements for use in lactating cattle.
- Elanco expects the product to become available in North America sometime during the third quarter. The company is also launching a carbon credit platform for dairy farmers to receive payments for reducing their emissions.
Dive Insight:
FDA approval of Bovaer comes months after the agency announced steps to accelerate the process to bring animal feed additives to market, overhauling a regulatory system that startups say was mired down by long, multiyear delays.
Elanco says it researched and developed Bovaer for more than 10 years, and the product is already available in more than 55 countries including the European Union. Canada moved to approve the product earlier this year.
"This monumental announcement has the ability to accelerate the opportunity for climate-neutral dairy farming while creating a new revenue stream for dairy farmers across the country,"Jeff Simmons, Elanco Animal Health president and CEO, said in a statement. "We appreciate FDA's commitment to maintaining high standards for science-based review, while balancing the need to quickly bring solutions to the market."
Bovaer is a powdered supplement that can be added to animal feed and works by suppressing a cow's ability to produce methane during the digestive process. The company says feeding each cow one tablespoon per day can reduce annual methane emissions by 30%, or the equivalent of 1.2 metric tons of carbon dioxide.
Methane from cattle digestion and manure makes up 4.5% of total U.S. emissions, or roughly 45% of U.S. agricultural emissions nationally, according to the University of Wisconsin-Madison. Although several startups have tried to tackle the problem through novel supplements, regulatory delays have prevented companies from bringing their products to the U.S. market.
"Bovaer holds the key to a transformative shift in the global dairy sector, and launching this feed ingredient in the U.S. after years of dedicated research, trials, and industry collaboration is a testament to its global potential," said Dimitri de Vreeze, CEO at dsm-firmenich, which teamed with Elanco to accelerate Bovaer's approval in the U.S.
Dairy farmers who use Elanco’s supplements can also earn additional revenue through a partnership with Athian, which operates a marketplace for dairy farmers to sell carbon credits. Farms can use Elanco’s digital tool UpLook to quantify emissions reductions and then easily certify carbon credits on Athian’s platform.
In 2018, the FDA approved Elanco’s Experior, which can reduce ammonia emissions from beef cattle. The move was the first time the agency approved an animal drug reducing gas emissions from an animal or its waste.