The reauthorization of the Animal Drug User Fee Act, commonly referred to as ADUFA is coming up for renewal at the end of September 2023. This act was introduced and passed originally in 2003 and has been reauthorized every five years, (2008, 2013, and 2018) with strong bipartisan support in the House and Senate. The purpose of ADUFA is to facilitate drug manufacturers in introducing new drugs to the market through the required FDA approval process.
By going through the formal FDA approval process, it allows the FDA to study and evaluate a drug's efficacy in doing what the manufacturer claims the drug will do. At the same time, the approval process requires testing to demonstrate the effectiveness, additional studies are required to demonstrate no unintended consequences in the target animal species being treated while assuring the consumer there are no issues such as drug residues that may affect the consumer.
Without the reauthorization of ADUFA, the consequences will inhibit or slow down the research, development and manufacturing of new animal drugs. This will prevent new and innovative drugs from coming to market for our producers that they rely on to keep their livestock healthy and productive.
The types of drugs that ADUFA was authorized for were primarily pharmaceuticals, including antibiotics and drugs that create more effective feed to weight gain conversion rates for the food animal industry. The animal protein produced becomes part of our food chain, which is eventually consumed by people. These drugs go through extensive testing prior to making them available to market to ensure there is no deleterious effects to the animal or any residues in the meat we eat and milk we drink.
The U.S. food animal industry encompassing meat, eggs and milk products produced by our farmers and ranchers is of the highest quality of food sold both domestically and around the world. The USDA stamp of approval is the gold standard of ensuring the products are wholesome and healthy and those products bring a premium for that standard. The FDA approval process, along with ADUFA is an integral part of this assurance.
This year's ADUFA has an amendment called the Innovative Feed Enhancement and Economic Development (Innovative FEED) Act of 2023 (S.1842) trying to be attached to it. This bill would allow for a catch all classification of additives, “zootechnical animal food substances” or “zootechnicals,” to be added to our livestock feed for animal protein production and entering the human food chain for consumption without the rigors of safety and effectiveness testing required for FDA approval of animal drugs.
There are three points I would caution the “Authors and Supporters” of this legislation to consider before attaching it to the reauthorization of the 2023 ADUFA legislation. One: the concern of adding something to our food supply which has no scientific evidence or studies to determine what effect it could have on the animal with long term consumption of these additives, or the environment, is highly irresponsible and concerning. One also has to consider, what effects on humans after both short- and long-term consumption of the end product (food), that contains these zootechnical products.
Two: How will the addition of “zootechnical food substances” affect trade with other nations. We have seen in the past and currently the refusal by our trading partners to accept products produced in the U.S. that do not meet a country’s phytosanitary requirements. We have seen this with our pork producers that at one time used Ractopamine and the Asian countries blocked these pork products and even though it is no longer used, it still is an impediment to trade. The European Union and Canada prohibited dairy products from cows given BST, a hormone that increased milk production.
Don't miss a beat! Sign up for a FREE month of Agri-Pulse news! For the latest on what’s happening in agriculture in Washington, D.C. and around the country, click here.
The EU has their own approval process for approving feed additives under the oversight of the regulatory agency and program called EFSA, (European Food Safety Authority). This EFSA authority has stated: “Feed additives may not be put on the market unless they have been authorized following a scientific evaluation carried out and reviewed by EFSA demonstrating that the additive has no harmful effects on human and animal health and on the environment.”
Meanwhile, the Innovative FEED Act lacks clarity on defining how safety and effectiveness will be determined. Therefore, by adding a feed additive that has not been tested and approved cooperatively by the United States and our recipient trading partner will definitely reduce trade in meat and milk products thus damaging our trade in these products.
The third and final point is: S.1842, if tacked on to ADUFA reauthorization will be a contentious issue and stop ADUFA from being approved. This will bring confusion to the animal drug manufacturing industry that needs certainty to develop the next generation of the necessary drugs to keep our livestock industry strong.
I urge the Senate to remove S.1842 from this year’s ADUFA based on the above discussion and pass a clean ADUFA reauthorization. Let the “zootechnicals” go through the proper testing to earn the confidence of the American people and our trading partners that our U.S. produced food is the safest on the planet.
Former Rep. Ted Yoho, R-Fla., served on both the House Agriculture Committee and the House Foreign Affairs Committee. He practiced food animal medicine for 28 years.
For more ag news and opinions, visit Agri-Pulse.com.
