Companies bringing a new biotech crop to the market currently face a costly, endless bureaucratic nightmare. No less than three federal agencies are involved. The process generally takes about 10 years. And it costs millions of dollars.
So President Trump signed an executive order in June directing the EPA, USDA, and FDA to streamline the regulatory procedure. It tasks the three agencies to do a number of things, including identifying regulations that can be streamlined and coordinated, create one website with guidance for companies trying to wade through the process, and remove unnecessary barriers for the technology to get to market. The order also asks the Secretary of State’s office to encourage dialogue to make biotechnology more acceptable to our trading partners.
The move comes after a lot of input on the current state of biotech regulations. The 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products and the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology clarified the federal government’s role and responsibility in overseeing biotech crops. And the Agriculture and Rural Prosperity Task Force established in 2017 recommended further action to modernize the regulatory framework. The task force recommended ensuring coordination between regulatory agencies to maximize the benefits of biotech crops, while also making sure they’re safe for human consumption and use.
Biotech regulations should focus on ensuring crop safety for farmers, humans, animals, and the environment. It shouldn’t be used as an expensive barrier to block potential crops. Unfortunately, that’s where the current regulatory system stands.
I can still remember the exasperation in Neal Carter‘s voice when I asked him about the frequent criticism that GMOs are unregulated. Neal is the President of Arctic Apples, the non-browning apples. He told me then: ” Oh my goodness, that is a pretty stringent science based and onerous undertaking, let me tell you. You know people who make comments about the regulatory agencies and the lack of regulatory oversight really don’t understand the process, because it is extremely rigorous and, in fact, we are now heading towards a four years of science review and due diligence around this product. And when it comes to the regulatory requirements, they require an equivalent of four or five Ph.D.s.”
So the Executive Order is a step in the right direction. We don’t have to sacrifice safety and environmental stewardship. But we should remove unnecessary regulatory hurdles that don’t protect the public. Bringing all three agencies together should help increase transparency and build public trust. And it will help the companies, universities, and private innovators with new biotech products navigate the regulatory process with less hassle and cost.
Now the EPA, USDA, and FDA need to step up to the plate to streamline the regulatory process. And hopefully we can see a whole new generation of biotech crops enter the market faster and cheaper.