Opinion: A Healthy and resilient world needs animal biotech innovation

The COVID-19 crisis has delivered a devastating blow to every segment of our society, and our nation’s agriculture sector is no exception. Our food supply chain has been tested; our rural economies are suffering; and our farmworkers are on the front lines of risk. The need for innovation and resilient solutions has never been more urgent.

These unprecedented challenges were top of mind during the recent annual meeting of the National Association of State Departments of Agriculture (NASDA). I’m very proud that NASDA has adopted a new vision statement: “Agriculture leads the way toward a healthy and resilient world.”

Fundamental to this idea of resilience is the role of innovation.  America has always been the global leader in agriculture innovation, and we have made some great strides. But our regulatory system for animal agriculture – specifically animal biotechnology – has not kept pace with science. 

The pandemic continues to remind us about the importance of the One Health initiative adopted by the federal government to better understand the link between human and animal diseases. Sixty percent of human diseases begin in animals. As populations grow and move, zoonotic diseases will become more prevalent and potentially more dangerous.

One Health solutions, many made possible through biotechnology, can protect the health of our livestock, enhance human health, safeguard our economy, and strengthen our systems for preventing and responding to future outbreaks. 

Biotechnology, for example, can arm pigs with resistance to African Swine Fever, protect American pork producers from significant economic loss, and create resiliency in our nation’s food supply. Scientists have also developed a chicken that is resistant to contracting and transmitting avian influenza. And researchers are using gene editing to make pigs resistant to Porcine Reproductive and Respiratory Syndrome (PRRS).

The economic benefits alone would be considerable. The 2015 outbreak of avian influenza cost the United States $3.3 billion. And a recent Iowa State University study estimates that an African Swine Fever outbreak in the United States could cost up to $50 billion. PRRS – a viral disease affecting the U.S. pork industry – already costs upwards of $664 million annually.

More urgent perhaps is the potential human health impacts. Advances in animal biotechnology can help prevent, prepare for, and respond to outbreaks of infectious diseases such as COVID-19, Ebola, MERS, Zika, among others, by providing prevention strategies and treatments for humans.

The need for science-based solutions is urgent, but these breakthroughs are being held back by an awkward and unworkable regulatory system.

The U.S. animal biotechnology regulatory process – currently under the Food and Drug Administration (FDA) – is confusing, unpredictable, and in dire need of reform. For technology developers, there is no way to know how long it will take, or how much it will cost before products are approved for market. 

There has been only one food animal approved to date. AquaBounty’s salmon, genetically engineered to grow to market size twice as fast using 25 percent less feed than traditional salmon, was under consideration by the FDA for more than two decades. Most small companies can’t survive such delays and red tape.

If there were a clearer path to commercialization, U.S. companies, start-ups, universities, and independent researchers could be developing cutting edge solutions, bolstering local economies, and creating high-paying jobs. Instead, animal biotech researchers and investors are moving to other countries such as Brazil, Argentina, and China.

Part of the problem is FDA’s approach, which requires these animals to be regulated under the “New Animal Drug” model. It creates potential problems for farmers and ranchers to have their animals treated as “drugs” and their farms to be regulated as “drug manufacturing facilities.”

Over the past decade, both the Obama and Trump administrations have stepped up efforts to streamline biotechnology regulations, especially for crops and plants. Now we must do the same for our animal biotech sector.

One potential solution is an agreement between the FDA and the U.S. Department of Agriculture (USDA). The USDA, with expertise in food production, could lead regulatory oversight of genetically modified and gene-edited food animals. The FDA could maintain authority over animal biotechnology for biomedical purposes. 

The FDA should also reexamine its process and make the necessary changes so decision-making is risk-based, consistent, and streamlined. Stakeholders need to have confidence that the FDA pathway to commercialization is clear and that timelines are reasonable and predictable.

As NASDA’s new president, I urge our federal officials to prioritize innovation, commit to long-range policies, cooperate with each other, and act thoughtfully. We need policies that will redefine agriculture toward a healthy and resilient world. Innovation is essential to making that goal a reality.

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