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FDA approves Bovaer for use in US lactating dairy cattle

The U.S. Food and Drug Administration (FDA) has completed its review of methane-reducing feed ingredient Bovaer (3-NOP) and has determined the product meets safety and efficacy requirements for use in lactating dairy cattle.

Dairy Cows
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The U.S. Food and Drug Administration (FDA) has completed its review of methane-reducing feed ingredient Bovaer (3-NOP) and has determined the product meets safety and efficacy requirements for use in lactating dairy cattle.

Elanco Animal Health, which has exclusive licensing rights to the DSM-Firmenich product in the U.S., said it expects to make Bovaer available to producers in the U.S. in the third quarter of this year. Additionally, the two companies expanded its commercialization agreement across North America to include Canada and Mexico – both countries which have already granted market authorization for Bovaer.

“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,” said Jeff Simmons, president and CEO, Elanco Animal Health. “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 represents another example of Elanco being a partner of choice in animal health, where the capabilities of our talented R&D, regulatory and commercial teams are delivering significant value.”

Bovaer works by suppressing the enzyme in the cow’s rumen that forms methane. Feeding one tablespoon of Bovaer per lactating dairy cow per day can reduce methane emissions about 30% or about 1.2 metric tons of carbon dioxide equivalent (CO2e) emissions annually, while creating opportunity for dairy farmers to be financially rewarded for reducing their dairy’s carbon footprint. Feeding 1 million cows Bovaer would reduce emissions equivalent to removing more than 285,000 cars from the road for a year. Feeding Bovaer to cattle has proven to be safe for animals, producers and consumers.

“We congratulate Elanco and the U.S. dairy sector, on this important milestone, and will support Elanco by providing initial supplies from Europe,” said Dimitri de Vreeze, CEO at DSM-Firmenich. “This strategic collaboration exemplifies how we can accelerate the expansion and adoption of Bovaer in North America to significantly decrease methane emissions on a large scale, and thereby support global efforts to combat climate change. 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.”

Dairy farmers incorporate Bovaer into their rations and quantify the effect using carbon market-friendly tools like UpLook by Elanco, an insights-based engine designed to quantify greenhouse gas emissions reductions. The tool utilizes on-farm data and peer-reviewed science to identify key drivers of an operation’s carbon footprint and track the progress of sustainability efforts. UpLook connects seamlessly to Athian, the first-of-its-kind livestock carbon inset marketplace. This seamless process allows farmers to quantify their emissions reduction efforts and certify carbon credits for sale. In addition to the carbon marketplace, the U.S. Department of Agriculture has awarded US$89 million in funding to support farms using technologies like Bovaer to reduce their methane emissions.

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