The staff at OrganicEye has received multiple inquiries concerned about a feed additive for ruminants designed to reduce “emissions.” Although, we felt confident it wasn’t approved for use in USDA certified organic dairy products, we decided to take a deeper dive.
On May 24, 2024, the U.S. Food and Drug Administration (FDA) reviewed Bovaer, a feed supplement designed to reduce “enteric methane emissions” (burps and farts) in lactating dairy cattle, and stated:
Although Bovaer® 10 is an unapproved drug, at this time we do not intend to initiate enforcement action with respect to the drug requirements listed above for Elanco’s marketing Bovaer® 10 or use provided FDA continues to have no questions or public health concerns about Bovaer®.
The product is being marketed in North America by Elanco and DSM-Firmenich.
Bovaer® is the brand name for 3-Nitrooxypropanol (3-NOP), the active — and synthetic — ingredient in the feed supplement. Other components are:
- silicon dioxide: essentially, sand — acts as a carrier
- propylene glycol: a food stabilizer
So what does that mean for US organic dairy farmers?
FDA permission to market and use an “unapproved drug” does not mean USDA National Organic Program approval.
To date, the National Organic Standards Board (NOSB) has not addressed the use of 3-Nitrooxypropanol (3-NOP), a synthetic substance, in dairy cattle certified organic under the NOP Livestock Scope. No synthetic substances can be used in organic production without the review and approval of the NOSB.
However, silicon dioxide and propylene glycol are approved for use with specifications:
Propylene glycol: (CAS #57-55-6) is listed as a synthetic substance allowed for use in organic livestock production only for treatment of ketosis in ruminants.
Silicon dioxide: NOP Rule §205.237(a) allows for the use of nonsynthetic, nonagricultural substances to be used as livestock feed additives and feed supplements, unless specifically prohibited. Only nonsynthetic, mined mineral versions of silicon dioxide are allowed to be used in feed for organic livestock. Synthetic materials used for the same purposes must be on the National List at §205.603.
While US, Canada, the UK, and Japan have already allowed use of 3-Nitrooxypropanol (3-NOP) as a feed supplement for lactating cattle, the UK Soil Association Charity and Soil Association Certification have stated:
“Soil Association organic standards stipulate that all ingredients/components of a feed additive must be actively approved for use and be deemed safe and nutritionally useful for the animal. The main components that make up Bovaer® are not included in the list of approved products/compounds and as a result, Bovaer® would not be permitted under organic standards and for use in organic farming.”
At the October NOSB meeting in Portland, Oregon, the Livestock Subcommittee did not bring up 3-Nitrooxypropanol (3-NOP) as a feed supplement for lactating cattle for discussion. At the time, that would’ve required a pending petition from the manufacturer. Currently, there is no pending petition.
OrganicEye will monitor any discussion of the use of 3-Nitrooxypropanol (3-NOP) as a feed supplement for lactating cattle at the spring NOSB meeting scheduled for April 29 – May 1, 2025 in Tempe, Arizona.