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Serving: MO
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CLEAR PATH: Many biotech advancements from a lab stall because of red tape in the regulatory process. With new diseases entering both animal and human arenas, now is the time for government to work together to move solutions forward.

Unleash the next frontier of animal agriculture

Animal biotech regulations hold back livestock health; it's time to streamline the process.

It’s been more than 20 years since I joined the Chinn family hog farm. For generations, my own family raised row crops and livestock in Illinois, so jumping into hog production was a new adventure at the time.

Since then, keeping our livestock disease-free has taken on a new sense of urgency, not only to safeguard our herds from foreign animal diseases, but also to protect our economic health. Doing so will require our federal partners to be forward-thinking, cooperate with each other and act thoughtfully.

Innovations in animal science have helped U.S. livestock producers to become the world's leading suppliers of high-quality, safe and affordable protein. The U.S. has always been the global leader in agricultural innovation, so what else can we do in the agriculture tech space to protect our livestock from diseases and protect our rural economies from the risks of outbreaks?

Battle pork problems

One concern for Missouri producers is the threat of porcine reproductive and respiratory syndrome, a highly contagious disease that costs U.S. farmers more than $660 million annually. Currently, there is no effective vaccine, but new animal breeding tools such as gene editing offer tremendous promise to protect hog operations from PRRS.

Researchers at the University of Missouri have bred piglets with resistance to the disease. After learning that a specific protein helps spread PRRS, scientists were able to edit the gene that makes that protein and stop the pigs from producing it.

The breakthrough could not only save the industry hundreds of millions of dollars every year, but it also could help us address other diseases in pigs, cattle, chickens and other food animals. There have been similar biotech discoveries that could arm pigs with resistance to African swine fever and make chickens resistant to contracting and transmitting avian influenza.

Aside from the advancements in animal welfare, the economic benefits would be considerable. A recent Iowa State University study estimates that an African swine fever outbreak in the U.S. could cost up to $50 billion. The 2015 outbreak of avian influenza alone cost the U.S. $3.3 billion.

Regulation slowdown

More urgent perhaps are the potential human health benefits. Innovations in animal biotechnology may be able to prevent, prepare for and respond to outbreaks of infectious diseases such as COVID-19, Ebola, MERS and Zika, among others, by providing prevention strategies and treatments for humans.

These innovations are moving forward in slow motion until the regulatory pathway for animal biotechnology is streamlined. Currently, there is no time frame for the approval process; it’s confusing, burdensome and unpredictable.

Developers have no way of knowing how long it will take, or how much it will cost them, before their products are allowed to get into the hands of livestock producers. This has had a negative effect on investment and growth of U.S. animal biotech startups.

As director of agriculture, I see an opportunity to work on the U.S. Food and Drug Administration’s approach, which is based on the “New Animal Drug” model. Evaluating animals under this pharmaceutical-based framework is like forcing a square peg into a round hole. It also creates problems for farmers and ranchers because their animals are regulated as “drugs,” and their farms are regulated as “drug manufacturing facilities.”

The White House has stepped up efforts to streamline regulations, especially the regulatory system for plant biotechnology. So, now is the time to address animal biotechnology before America loses its position as an innovation leader. Investment, research and high-paying jobs already have been lost to other countries such as Brazil, Argentina and China.

Collaborative solutions

A logical solution could be an agreement between USDA and the FDA.

USDA, with its expertise in food production, should lead regulatory oversight of genetically modified and gene-edited food animals. The FDA should maintain its authority over animal biotechnology that is used for biomedical purposes. 

Furthermore, FDA needs to take a closer look at its process: There needs to be a more streamlined decision-making process, increased transparency and clear timelines. Developers and other stakeholders need to have confidence that the FDA pathway to commercialization is clear, consistent, risk-based and predictable.

The Midwest is a hub for animal biotechnology innovation. U.S. companies, startups, universities and world-class research institutions are working on the cutting edge of this exciting branch of science, bolstering local economies and providing high-paying jobs.

But if there is no clear path for technologies to be approved and commercialized, these operations will close. Missouri and our neighboring states have a lot at stake: the livelihood of our livestock operations, the health of our local economies, relationships with our trade partners, and our position as a leader in ag innovation.

Now more than ever we must invigorate investment, generate cures, transform our food system and sustain our economy. Now is the time for policy to catch up to science.

Chinn is the director of the Missouri Department of Agriculture and a hog producer from Clarence, Mo.

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