Biotechnology and biosafety under the Trump administration: The devil will be in the details

By Greg Jaffe

January 23, 2018

Soybean plants in Hawaii. Photo: Robert Hazen
Soybean plants in Hawaii. Photo: Robert Hazen

In 2017, agricultural biotechnology was not high on the US Department of Agriculture s (USDA) policy agenda. Then, this month, the USDA released its report on Agriculture and Rural Prosperity, which highlights the value of biotechnology innovation in US agriculture and recommends streamlining biotechnology regulations.

While the report s recommendations don t seem to differ from positions taken by the Obama administration, it will be important to watch how the Trump administration implements them in the coming months.

The Agriculture and Rural Prosperity Report

The USDA report states that biotechnology is an area of US leadership and a driver of the fourth industrial revolution that presents an incredible opportunity for American farmers and rural communities to thrive at the forefront of innovation. It finds that biotechnologies have enabled US farmers to increase the supply and quality of crop and livestock commodities using fewer resources and at lower costs of production. However, it concludes that federal regulations are limiting biotechnology applications and that better coordination among regulatory agencies is needed to reduce barriers to commercialization of safe, beneficial and improved genetically engineered entities.

The report recommends a streamlined, science-based regulatory policy for biotechnology. It reaffirms the current administration s support for two documents released by the Obama White House: the Coordinated Framework for the Regulation of Biotechnology and the National Strategy for Modernizing the Regulatory System for Biotechnology Products. It calls for the White House s Office of Science and Technology Policy (OSTP) to coordinate and improve science-based regulatory approaches among the relevant agencies. (This is all well and good, but the fact is that OSTP has been decimated under the Trump administration and only has a shoestring staff.) Finally, the report calls on OSTP to create a forum that connects federal funding agencies with regulators so those regulators will be aware of biotechnology products coming to market and can speed their commercialization.

Putting the Report into Practice

Reading the USDA report and its biotechnology recommendations, three thoughts about its implementation immediately surface. First, the report uses all the politically correct phases when discussing government oversight. It mentions transparency, predictability, efficiency, risk-based, and science-based all of which are concepts and principles that both proponents and opponents of genetic engineering agree are appropriate when developing federal regulatory oversight.

It also states that the regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation. What we don t know is how these occasionally competing goals will be achieved and what trade-offs will be made when a conflict arises. In many cases, safety can be advanced while also promoting innovation and jobs, but if that is not possible, safety must be paramount. The Trump administration should strive for appropriate risk-based oversight, and should not rush, in a deregulatory zeal, to eliminate regulations that are needed to ensure safety and consumer confidence, both domestically and internationally.

In addition, the USDA report suggests that the problems with the regulatory system would disappear if only the three regulatory agencies the USDA, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA) were better coordinated. However, many of the problems with the USDA s current regulation of GE plants have nothing to do with the other agencies.

For example, a developer who introduces a gene with a herbicide-tolerance trait into a corn plant may or may not need a permit from the USDA to release that crop into the environment. This depends, almost exclusively, on how the new gene is introduced into the plant. If the developer uses Agrobacterium, which is a plant pest, the GE crop will require USDA oversight. If the gene is introduced using a gene gun (which is a mechanical device) or CRISPR-Cas9 neither of which is a plant pest the GE crop probably escapes USDA oversight. Those three versions of the same GE crop with the same potential risks to the environment get different regulatory treatment.

The USDA regulatory system is neither science-based nor risk-based and no amount of coordination with other agencies will change that. Instead, the USDA needs to adopt risk-based and proportionate oversight of products so that little or no oversight is required for safe and familiar products, and risk assessments and approval are mandatory for novel or potentially risky products.

Finally, the USDA report emphasizes the need for the USDA, the Department of State, and other relevant agencies to better communicate with the public about biotechnology products to improve consumer acceptance in the US and abroad. The report says that more efficient and effective communication must be employed to build evidence-based confidence in the safety of products for health and the environment. Without directly saying it, the report suggests that if only consumers knew the truth about GE crops, they would be more willing to accept them. The report does not mention the FDA s Agricultural Biotechnology Education and Outreach Initiative, which is supposed to be coordinated with USDA.

Information from the government about GE crops may convince some consumers, but public trust in the government is required for that to happen. And trust in the Trump administration is anything but high. Consumer acceptance is more likely if GE products are developed by the public sector or if products have clear consumer value. Consumers are more likely to support GE products if they hear about their benefits and safety from a respected stakeholder (a farmer or scientist).

Overall, the USDA report is not groundbreaking. It primarily reiterates policies and positions of the Obama administration. How (and how quickly) the report s recommendations are implemented will tell us how important agricultural biotechnology will be during the Trump administration. It will also be important to watch how the administration balances the cost of regulation with the need to ensure public safety and build consumer trust. The Trump administration should not radically reduce government regulation of GE crops. Instead, it should rethink its oversight to make it proportionate, risk-based, and responsive to new developments in this rapidly changing field.

Greg Jaffe directs the Biotechnology Project for the Center for Science in the Public Interest