If you care in the least about the sustainability of animal agriculture and of the planet we inhabit, read on.
There’s a bill in Congress that has far-reaching implications for both. S.1842/H.R. 6687, better known as the Innovative Feed Enhancement and Economic Development Act of 2023 (or the IFEED Act for short) is awaiting passage by the Senate and the House. The proposed legislation would amend the Federal Food, Drug and Cosmetic Act to create a shorter and more direct path to approval for animal-feed ingredients, including — and this is major — additives that have been shown to improve the health of livestock, reduce enteric methane emissions and/or improve overall food safety.
“All animal food ingredients must be approved for use,” says Leah Wilkinson, vice president of public policy and education at the American Feed Industry Association. “That can happen in various ways, but until recently, when an ingredient or additive came with health benefits, there was but one path to approval. The FDA looked at it as if it were a drug and then subjected it to the same long and cumbersome drug review process. It’s been taking upward of 10 years,” she says.
Per the IFEED Act, there would be a new category for substances such as feed additives that act solely in the guts of animals. The FDA would classify them as “zootechnical animal food substances,” which would put them on a different — and shorter — path to regulatory approval.
Perhaps anticipating the passage of the IFEED Act, the FDA recently made what Leah calls “a bold move” by stepping away from the policy of considering these ingredients drugs. In a letter to stakeholders dated Feb. 2, it said:
“The U.S. Food and Drug Administration is aware that the animal feed industry is interested in bringing to market animal food substances that act solely within the gut of the affected animal with scientifically substantiated claims related to animal production, animal well-being, food safety, and environmental benefits, as animal food. FDA encourages firms with these novel products for animals to contact the agency early in the product development process.
“To facilitate animal and veterinary product advancement, and to encourage the development of safe, novel products and products for unmet human and animal needs, FDA’s Center for Veterinary Medicine (CVM) intends to withdraw Policy & Procedures Manual (PPM) 1240.3605, Regulating Animal Foods with Drug Claims.”
Having some of the most promising food additives in regulatory limbo ranges from inefficient to concerning to darn-near disastrous. Frustrated with the process, feed companies are necessarily putting their eggs in offshore baskets, where new technology is embraced and brought to market much more quickly than here in the United States.
Our growers are behind the eight ball in all facets of sustainability — from economic to environmental — because they’re being deprived of the latest scientific developments. Standing as a shining example is 3-NOP, marketed by Elanco as Bovaer. One of the most extensively researched feed additives in existence, it has been proven effective in suppressing methane production in the stomachs of ruminants, which in turn, reduces enteric methane emissions. Furthermore, after Bovaer does its job, it’s broken down into nitrate and a bio-based alcohol, which are already present and processed by the cow’s normal digestive and metabolic processes.
Bovaer is being used successfully in more than 40 nations, including those in the European Union and the European Economic Area, plus Australia, Brazil, Chile, Pakistan, Switzerland and Turkey. But you won’t find it on farms and ranches in the United States because it’s stuck in the FDA drug review process.
However, the bipartisan and bicameral IFEED legislation has the potential to change that, to revolutionize the American feed industry by keeping us in a leadership position while we move the needle dramatically on the reduction of methane emissions from animal agriculture. Kudos to Senators Baldwin, Marshall, Moran and Bennet for bringing such a crucial bill to the forefront.
Leah and others at AFIA, not to mention nearly 200 stakeholders throughout animal agriculture, report a tremendous groundswell of support for the bill. And the FDA seems to be on board as well, given its recent announcement.
While withdrawing the regulation is well within its purview — and we in the industry applaud the move — the FDA is still looking for legislative direction, which is certainly understandable. In other words, we need our lawmakers to pass the IFEED Act and give the FDA the backing it needs. There is just so much riding on it.
“In the sprint to meet our 2030 methane reduction goals, as well as our 2050 goals, the importance of the regulatory time frame being shortened by potentially more than six years cannot be overstated,” says Charles Brooke, an expert in air quality who leads enteric methane field road mapping and program development at Spark. “The IFEED Act will allow the U.S. to maintain the integrity and safety of the food chain while accelerating the time to market, building trust for the use of these products, and serving as a strong signal for innovation in this space.”
Lest anyone think the new direction will come at the price of safety, rest assured that the condensed time frame won’t simplify the review. In fact, all the same science will be required. “It still will be highly regulated,” Leah says. “We won’t be skirting regulations. Rather, we’ll be going through the proper regulatory review. Products that act within the gut shouldn’t be considered drugs.”
We need our legislators to act and act quickly. Call, write, do whatever you can to make noise and let your representatives know how much is riding on this bill.
It’s not a nice to have. It’s a must have.
“Other countries are measuring emissions reduced, and we’re measuring time lost,” Leah says.
