UK Department of Environment, Food and Rural Affairs Announces Public Consultation on Regulation of Gene Edited Organisms
On January 7, the United Kingdom’s Department of Environment, Food and Rural Affairs (DEFRA) announced the beginning of a public consultation period on establishment of a regulatory approach to certain genome edited organisms that will treat such organisms separate from so-called genetically modified products (GMOs). The public consultation period on regulation of genome edited organisms will end on March 17, 2021.
DEFRA is proposing to not regulate genome edited organisms as GMOs if the genetic alterations in the genome edited organism could have been achieved by means of traditional breeding. DEFRA states that this approach is consistent with the approach taken by regulatory authorities in other countries, including Argentina, Australia, Brazil, and Japan. This approach is also consistent with the regulatory approach adopted by the US Department of Agriculture in its 7 C.F.R. Part 340 amendments and proposed by the U.S. EPA in its proposal to establish an exemption from regulation under FIFRA for certain plant-incorporated protectants (PIPs). DEFRA’s consultation proposal marks a possible rejection of the requirement in the European Union that genome edited products be regulated as GMOs. Rather, DEFRA’s consultation document states that “Our position follows the science, which says that the safety of an organism is dependent on its characteristics and use rather than on how it was produced.” This, of course, is consistent with the stated approach of the U.S. Coordinated Framework, which holds that genetically engineered products should be regulated on the basis of product risk not the process by which it was created. It is possible that regulatory change by DEFRA applicable to the limited subset of genome edited organisms where the genetic alteration could have been achieved by conventional breeding techniques could impact companies engaged in genome editing of plants, animals, and microbes that are used in food, feed, fuels, and industrial applications.
In addition, DEFRA also announced that it is beginning a separate process of gathering information regarding “the wider regulatory framework governing genetically modified organisms (GMOs).” As part of this separate information-gathering effort, DEFRA has requested public input on whether products such as crop plants, farm animals, human food, animal feed, and human and veterinary medicines that are produced using genetic engineering techniques require a separate regulatory approach as a result of the use of such techniques. In initiating the process of comprehensively assessing the proper scope of regulatory assessment specifically applied to genetically engineered products generally, DEFRA could take the international lead in developing a comprehensive regulatory approach to genetically engineered organisms that places science and fact-based evidence at the forefront of its regulatory process.