EPA publishes final rule on gene-edited plants

The US Environmental Protection Agency (EPA) has published a final rule on gene-edited (GE) plants exempting them from an in-depth review process if the change could have been achieved with conventional breeding, Science website reported on 2 June.

However, to ensure safety for humans and wildlife, the EPA said it would require developers to submit data to show plants that had been gene-edited to resist pests – for example by producing more of a naturally-occurring toxic protein – would not harm other components of the plant’s eco-system or people.

The EPA’s ruling followed a decision made last year by the United States Department of Agriculture (USDA) which exempted specific GE changes to plants. Developers, for example, were not required to ask for approval if they had given a crop a trait that already existed naturally in a sexually compatible plant, the report said. The EPA said on 25 May that it would use the conventional breeding exemption for many GE crops, although – unlike the USDA – it would require companies to submit confirmatory safety data, such as evidence that the changes did not increase pesticide levels beyond those found in food from conventional crops, Science wrote.

According to the EPA, regulatory review would be faster and cheaper for GE crops – in which existing genes are altered – against genetically modified crops where foreign genes are used.

Biotechnology expert Jennifer Kuzma of North Carolina State University said the EPA had struck a reasonable balance to ensure industry was thinking about risks to non-target organisms and humans when it came to pesticidal compounds.