US EPA proposes further streamlining approval of biotech crops

Developers of genetically engineered crops would have an easier time getting their products onto the US market under a proposed rule issued by the US Environmental Protection Agency on Sept. 1.

The rule applies to certain plant-produced natural products that act as pesticides and the genetic material that allows plants to make the substances. These substances, called plant-incorporated protectants (PIPs), have long been exempt from regulation under the federal pesticide law and the law that regulates pesticide residues on food, if they were created by conventional breeding. The EPA’s proposal would extend that exemption to include PIPs created with biotechnology.

To qualify for the exemption, the substances would have to pose no greater risk than those created by conventional breeding. It must also be possible to make the substances by conventional breeding. The EPA is allowing developers to determine whether their product meets that criteria or have the agency confirm that it does.

The EPA claims that exempting PIPs created with newer technologies, such as gene editing, would reduce costs for developers and lead to more pest control options for farmers. The agency estimates that 80% of such products would be developed by small firms, many of which are developing their products for use on minor crops. Since 1995, the EPA has registered PIPs for use on corn, cotton, soybeans, potatoes, plums, and papayas.

The EPA’s proposal follows a similar rule finalized in May by the Department of Agriculture to streamline the regulatory process for approving genetically engineered crops. Both actions were prompted by a June 2019 executive order from the White House that directed federal agencies to overhaul the process for approving crops produced with biotechnology to accelerate their entry into the marketplace and reduce costs for developers. The efforts mark the first time the process has been changed since 1987.

“This new rule will provide critical new tools for America’s farmers as they work to increase agricultural productivity, improve the nutritional value and quality of crops, fight pests and diseases, and boost food safety,” EPA Administrator Andrew Wheeler says in a statement. “Embracing this technology through a transparent, consistent and science-based process is long overdue, and will secure benefits to American agriculture well into the future.”

The EPA’s proposal will be open to public comments for 60 days once it is published in the Federal Register.