Blog: NGOs Propose Principles for the Responsible Governance of Gene Editing

Last month, a group of environmental, conservation, and consumer NGOs published principles for “responsible governance of gene editing in agriculture and the environment.” These principles are meant to be high level and to serve as “an invitation from our organizations to other stakeholders to join us in developing a governance framework for gene editing.”

Gene editing is a process to make targeted changes to an organism’s DNA, be it plant, animal, or microbe. The term is popularly used to describe small changes to genetic material, as opposed to the insertion of large pieces of DNA from other organisms, known as genetic modification — though gene-editing technologies can be used to do this as well. It’s also often described as making changes that could have otherwise been produced using older, conventional breeding techniques.

CRISPR was developed in 2015 and many CRISPR-edited plants are heading toward commercialization. In addition, a soybean plant that produces heart-healthy oil was developed using an older gene-editing technology and was commercialized in 2019. Other gene-edited plants with health and environmental benefits include a high-fiber wheat and a virus-resistant tomato, and the USDA’s new 2019 regulation framework for gene editing could ease the commercialization process for these products as well as others. There are also several efforts by stakeholders to come up with principles, guidelines, and responsible-use frameworks for funders, developers, and regulators of gene-edited products that go beyond federal regulations.

The six principles developed by a group for “responsible governance of gene editing in agriculture and the environment” are summarized in the figure below:

These principles are high-level enough that many organizations would support them, which is a good place to start. The more difficult task — of deciding how to apply these principles in practice — comes next. Below, I will discuss two of these principles and how they might be applied.

In order to satisfy the principle of transparency, the authors suggest a national registry of gene-edited products that have been released (variations of which have been suggested before by many stakeholders). In USDA’s 2019 SECURE rule, three types of gene-edited changes that could otherwise have been made using conventional breeding are exempted upfront from regulation under SECURE, with developers self-determining whether their product qualifies for an exemption. A registry would address the common fear of developers abusing self-determined exemptions, though if participation is not required it would be less effective for this purpose or for the purpose of transparency generally.

Ideally, I would like to see this registry include not only gene-edited products, but all new products developed using any method, whether conventional breeding (including mutagenesis), genetic modification (including transgenesis), or gene editing. Being able to see the products of all these different breeding methods in one place would allow the public to compare tangible examples and understand the continuum of changes possible through all of these methods. Including all breeding methods in the registry wouldn’t single out gene-edited products and give the incorrect impression that they are somehow unique or more dangerous than products of conventional breeding or genetic modification.

In order to best satisfy the principle of effective, science-based government regulation, self-determined exemptions under SECURE should be based on the traits of products developed using any method of gene editing or genetic modification. Currently, however, SECURE bases self-determined exemptions on the type of genetic change or technique used, which is a less effective and less science-based proxy for risk. If self-determined exemptions were trait-based, they could be for predetermined categories of products that have low-risk traits. Unfortunately, it’s not realistic to expect this large of a change in USDA regulation anytime soon because the 2019 SECURE rule marks the first overhaul of USDA regulation of genetically modified organisms in 30 years (not to mention the revised rules proposed in 2008 and 2017 that were subsequently withdrawn).

As a wider group of stakeholders participate to form a governance framework for gene editing based on these principles, it will be important to ensure that the framework as a whole will still, “balance societal safeguards with timely, efficient access to benefits,” as the authors state for the principle of effective, science-based government regulation.