By Sarah Gonzalez, Director of Communications and Digital Media
President Donald Trump directed the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) to streamline their regulation of agricultural biotechnology in an executive order issued June 11.
“The United States must employ a science-based regulatory system that evaluates products based on human health and safety and potential benefits and risks to the environment,” the executive order stated. “Such a system must both foster public confidence in biotechnology and avoid undue regulatory burdens…Any regulatory regime for products of agricultural biotechnology should ensure public confidence in the oversight of such products and also promote future innovation and competitiveness.”
While it is too early to determine the precise impact the new executive order will have on U.S. government review and oversight of agricultural biotechnology traits, including new gene-edited techniques, the NGFA will reiterate the importance of U.S. government policies not further disrupting the domestic or international marketability of grain and grain products.
Under the order, the leaders of the three U.S. agencies that have regulatory jurisdiction over agricultural biotechnology – the EPA, FDA and USDA – are given 180 days to identify ways to streamline their regulations and design a plan for an online system for companies to submit biotech approval requests.
Further, the agencies have 120 days to outline an international outreach plan, as well as a strategy “to remove unjustified trade barriers and expand markets for products of agricultural biotechnology.”
The executive order does not include any specific regulatory changes.
USDA already published a new proposed rule on June 6 for the regulation of plant-based agricultural biotechnology products. Under the proposed rule (known as “Part 340”), USDA’s Animal and Plant Health Inspection Service (APHIS) – which has authority to determine whether agricultural biotech traits pose a plant pest or noxious weed risk to the environment – would exempt most crops developed with gene-editing techniques from regulation. APHIS said gene-edited plants can be produced through traditional breeding techniques, making them unlikely to pose a greater plant pest risk than conventionally bred crops. The APHIS proposal also would empower crop developers to make a “self-determination” that their plant is exempt from APHIS regulatory oversight. They would have the option to request written confirmation from APHIS that their self-determination is valid.
Greg Jaffe, biotechnology director for the Center for Science and the Public Interest, said he’s concerned about both the executive order and proposed rule serving as a potential “blank check” for USDA, FDA and EPA to “deregulate whole categories of products.”
The NGFA also is concerned that the “self-determination” approach in the proposed rule could put the United States out of step with the regulatory systems of important international markets for U.S. agricultural products, and would not provide sufficient transparency regarding which gene-edited crops are present in the food supply. NGFA intends to submit comments to APHIS outlining these concerns as part of the rulemaking process.