June 26, 2022

Volume XII, Number 177


June 24, 2022

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June 23, 2022

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EU Seeks Input on Policy for Plants Developed Using New Genomic Techniques

In July 2018, the Court of Justice of the European Union (ECJ), the EU’s Highest Court, issued a decision clarifying whether the EU would regulate products of innovative breeding techniques, like gene editing, under the EU’s Directive 2001/18, the principal EU law governing the regulation of GMOs.

As we explained previously, the ECJ held that while traditional forms of mutagenesis—a plant breeding technique that does not require the insertion of DNA from outside organisms—were excluded from the Directive, organisms developed using new genomic techniques (NGTs), including gene editing, would be regulated as GMOs and therefore subject to restrictive and onerous regulatory requirements. The ECJ determined that excluding organisms developed using newer mutagenesis techniques, such as gene editing, was appropriate because the newer techniques have not been “conventionally . . . used in a number of applications” and do not “have a long safety record.”

In November 2019, the Council of the European Union requested that the European Commission submit a study regarding the status of NGTs under EU law and, if appropriate, a proposal regarding such techniques accompanied by an impact assessment.

The European Commission’s study, published in April 2021, included the following findings:

  • “NGTs and their products have been rapidly developing in the last 20 years in many parts of the world, with some applications already on the market of some EU trade partners.”

  • “Under the current EU regulatory system, there are implementation and enforcement challenges, in particular related to the detection and differentiation of NGT products that do not contain any foreign genetic material.”

  • “There is considerable interest for NGT-related research in the EU.”

  • “There are indications about both benefits and concerns associated with NGT products and their current and future applications.”

  • “[P]lant products with similar risk profiles can be obtained with conventional breeding techniques, targeted mutagenesis[,] and cisgenesis.”

Among other things, the European Commission concluded that “[t]here are strong indications that the applicable legislation is not fit for purpose for some NGTs and their products, and that it needs to be adapted to scientific and technological progress.” In discussing next steps, the European Commission noted its plans “to initiate a policy action on plants produced by targeted mutagenesis and cisgenesis, which will involve an impact assessment including a public consultation.” Though not stated explicitly, it appears clear that the European Commission’s use of the term “targeted mutagenesis and cisgenesis” refers to certain techniques that could be deemed NGTs.

Late last month, the European Commission opened public consultation to receive “citizens’ and stakeholders’ views on the functioning of the current GMO legislation for plants obtained by targeted mutagenesis and cisgenesis and their food and feed products, i.e., under the current GMO legislation, and on potential options for a new framework.” In discussing the public consultation, Stella Kyriakides, European Commissioner for Health and Food Safety, stated that: “Plants obtained with new genomic techniques could help build a more resilient and sustainable agri-food system. Our guiding principle will remain the safety of the environment and consumers.”

The European Commission explained that it is “preparing a policy initiative on plants obtained by targeted mutagenesis and cisgenesis,” which “will also cover food and feed derived from such plants.” Furthermore, “the initiative aims at an appropriate regulatory oversight for the concerned plant products, ensuring a high level of protection of human and animal health and the environment, and enabling innovation and the contribution of plants obtained by safe NGT[s] to the objectives of the European Green Deal and the Farm to Fork Strategy.”

This consultation offers a valuable opportunity to help shape the future of a wide-reaching policy initiative with significant impact on this industry. Responses to the consultation can be submitted by filling in an online questionnaire, available here, until July 22, 2022 (midnight Brussels time).

© 2022 ArentFox Schiff LLPNational Law Review, Volume XII, Number 140

About this Author


Shoshana advises clients on the legal and regulatory landscape for matters that fall within the jurisdiction of the US Food and Drug Administration (FDA), Department of Agriculture (USDA), Environmental Protection Agency (EPA), and their state counterparts.

Examples of her work include:

  • Providing guidance on the newly established FDA Over-The-Counter Monograph Drug User Fee Program

  • Counseling on compliance with the federal Clinical Laboratory Improvement Amendments (CLIA)...

Stanley H. Abramson Biotech, Food, and Drug Attorney Arentfox Schiff LLP Law Firm

Stan represents clients before EPA, FDA, USDA, and the Congress; assists clients in obtaining approvals for agricultural, industrial, and consumer products including pesticides, biologicals, disinfectants, ag tech products, and products of biotechnology and other emerging technologies; defends challenges to products in federal court and administrative proceedings; develops corporate compliance and product stewardship programs; and conducts due diligence reviews.

Karen Ellis Carr Attorney Food and Agriculture Arent Fox Schiff Washington DC

Karen has experience in litigation and regulatory counseling, strategy, and advocacy, with a primary focus on products regulated by the United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA). Karen advises on pathways to commercialization for new products and technologies, advertising and labeling, testing and reporting, data use and compensation disputes, and litigation relating to product approvals. Karen has specific expertise with the Plant Protection Act, the National Bioengineered Food...