Regulatory restructure of biotech is critical to the future of US agriculture

Regulatory restructure of biotech is critical to the future of US agriculture
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Our world population is projected to reach 9.8 billion in 2050. This, coupled with limitations in arable land and water, means meeting our future food needs will require adding new innovative and transformative technologies to our current capabilities in agriculture.
 
Genetic improvement via gene editing is one of these innovative solutions to revolutionize agriculture, where we can deliver more sustainable animal health and welfare traits into our agricultural production systems with great precision, speed and economy. 
 
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On Feb. 6, members of the House Agriculture Committee voiced concerns to U.S. Secretary of Agriculture Sonny PerdueGeorge (Sonny) Ervin PerdueUS puts business ahead of children’s health Western states brace for most severe wildfire outbreak since 2012 Agriculture chief: Farmers 'understand' trade spat with China MORE about animal agriculture products developed with biotechnology being regulated by the FDA, not the USDA.
 
 
Congressman Neal DunnNeal Patrick DunnGOP lawmaker's chief of staff resigns amid sexual misconduct allegations: report Regulatory restructure of biotech is critical to the future of US agriculture Prioritizing anti-dumping policies in NAFTA renegotiation MORE (R-Fla.) said, “Over the past twenty years, the FDA has managed to approve only two animals. This undertow of the FDA’s regulatory regime is preventing potential products like avian influenza-resistant poultry and foot-and-mouth-resistant cattle from being commercialized.”
 
We can fully support putting the USDA exclusively in charge of regulating all food animals. My company has products ready for market that enable “naturally hornless” (polled) and “naturally cool” (heat tolerant) cattle. Both types of animals were bred by copying naturally-occurring traits already found in cattle.
 
Gene editing methods, like naturally-hornless and naturally-cool, are proven safe and provide identical outcomes at the genome sequence level as well as being expressed identically for animal type, behavior, and appearance, similar to what could be achieved using slower, traditional breeding methods.
 
Our initial research was funded by grants from the USDA’s National Institute of Food and Agriculture and completed with our private sector support. Since several agencies in USDA financially support efforts to research and apply new breeding tools, such as gene-editing in food animals, it only makes sense that the USDA would have the best organizational expertise and leadership to regulate these animals.
 
Furthermore, the USDA currently regulates gene-edited plants and has regulatory processes in place for non-edited food animals, including rigorous inspections of all animal products before allowing them into the food supply.
 
The USDA’s existing scientific methods of evaluating safety are proven, predictable and trusted by the public and lawmakers. There has not been a documented case where healthy animals (regardless of their DNA makeup) have created a food safety problem. Therefore, gene edited animal products should reside in USDA’s regulatory jurisdiction and not require any involvement by the FDA — which wrongly views the process of making gene-edited animals as “drug manufacturing.”
 
At the same congressional hearing, Rep. Don Bacon (R-Neb.) asked, “Can’t we ask FDA to change its approach? Is there are a better way to go about it? We’re losing $60 million in pork due to a disease called PRRS virus. And there’s a way to do gene editing to stop it, but FDA treats it as a heavy drug treatment. Therefore, it’s under heavy regulation.” 
 
One example how gene editing is illustrated by the health and welfare traits in swine. My company is also working to introduce a novel trait in swine that will eliminate the need for surgical or immunological castration. Other traits, such as preventing the PRRS virus infection in pigs, are also possible through gene-editing.
 
Many pork producers, conscious consumers, and animal genetics companies are already on board with this technology — which represents a commercial pull for these animal health and well-being traits. But under the current regulatory framework — with oversight from the FDA — our path to market is uncertain due to unknown time and cost for approval.
 
Whether it is providing alternatives to avoid surgical castration in male pigs or dehorning in cattle (where their horns are burned off, cut off, or dissolved through caustic chemical pastes), we can and should use technology to raise food animals when the opportunity provides a pain-free outcome of improved health and well-being.
 
Animal welfare groups, such as the U.S. Humane Society, already support gene-editing for animal health and well-being. Several breeders associations also want to bring these animal welfare traits into their elite genetic lines. In addition to our partnership for castration-free swine, we have partnerships with global genetics companies to distribute the polled and heat tolerance traits through their elite genetics to farmers and ranchers around the world. 
 
Fast action is needed, or the U.S. will be prevented from deploying this promising technology and risk losing our leadership position in livestock genetics and in global meat and dairy production and export. We are already out of sync with the rest of the world, including European authorities (and livestock breeders), who are increasingly characterizing such approaches simply as advanced breeding. Other countries, like China, Canada, Australia and Brazil, will be deploying this technology with or without the guidance of the United States. They will also begin to become more formidable exporters of their beef, pork, poultry and fish products.
 
Ag Secretary Sonny Perdue is the right leader to provide regulatory oversight during this critical time in ag innovation. He led the administration’s Task Force on Agriculture and Rural Prosperity and issued a report stating, “Despite American leadership in technological innovation in agriculture, Federal regulations are currently limiting both precision agriculture and biotechnology applications.”
 
We applaud Secretary Perdue and the Trump administration’s focus on fixing policies that drive jobs and innovation offshore. We hope Perdue will request a regulatory move from the FDA to the USDA for gene-edited food animals. It’s the right thing to do today for U.S. companies, ag producers, and animals. It’s also necessary to meet the future food demands of a growing and hungry population.
 
Tammy Lee Stanoch is the president & CEO of Recombinetics, an animal gene-editing company based in St. Paul, Minnesota.