Don’t Make Regulation of Gene-Edited Microbes Precautionary

Gene editing, especially CRISPR technology, has the potential to improve food production by making the microbes that live with plants better at helping them do important things like use fertilizer, fight off disease, and survive drought.

In the United States and many other countries, there is a lack of regulatory clarity for gene-edited microbes, and this confusion is keeping existing products off the market and slowing the development of new solutions. Getting regulations for gene-edited microbes right could help create a more environmentally sustainable agriculture sector, but one thing stands in the way: the Precautionary Principle.

Why the EU gets biotech so wrong

Broadly, the Precautionary Principle favors avoiding action when the potential impacts of that action are uncertain. The European Union is widely viewed as having based its regulation of genetically modified crops (GMOs) and gene-edited crops (e.g., using CRISPR) on the Precautionary Principle, and would likely take the same approach with genetically-modified or gene-edited microbes for agricultural use.

The EU views conventional breeding as well-known, predictable, and safe, and therefore it does not apply the Precautionary Principle. Conversely, it views biotechnology as unknown and potentially dangerous, and, therefore, subject to special scrutiny.

But the reality is not that simple. Conventional crop breeding still involves many unknowns. It is usually based on crossing plants of the same or closely-related species and other techniques, such as using chemicals or radiation to create random mutations. Throughout history, conventional breeding has been very safe. But that isn’t because of the nature of the process or how long it has been used. Rather, it is safe because of testing and regulation—that is, the screening and testing that breeders do to create intended traits and rule out unintended ones and regulation by the government of food safety.

Likewise, biotechnology is neither intrinsically safe nor intrinsically dangerous. As with conventional crop breeding, we understand how it works, and we have the tools to create intended outcomes. Since the 1980s, scientists have been using genetic modification to insert a gene into a plant from either a plant of the same species, a plant of a closely related species, or a more distantly related organism of a different species. Gene editing—or genome editing, a process for which CRISPR is the most well-known tool—is another type of biotechnology that allows scientists to make more precise changes to a plant’s existing DNA, either by changing or deleting one or more letters of the DNA code.

Like with conventional breeding, the outcomes of any biotechnology process is what should be regulated, not the process itself through some misapplication of the Precautionary Principle.

The United States’ progress on biotech

In the United States, the regulatory approach to agricultural biotechnology is not as precautionary as in the European Union, but it still does assume that researchers and regulators have less capacity to predict the impacts of the technology than they really do.

For example, the new United States Department of Agriculture (USDA) SECURE rule for the regulation of plant biotechnology in agriculture distinguishes some types of gene editing from genetic modification (GMOs) and applies a lower level of regulatory scrutiny because the genetic changes they produce could also have been made using conventional breeding technologies, which regulators consider to “have a long safety record.”

But that is almost as nonsensical a way to categorize outcomes as in the European Union. In the case of all three categories of technologies—conventional breeding, genetic modification, and gene editing—safety has little to do with the technology or the types of genetic changes and has everything to do with breeders’ screening and testing regimes.

In the case of agricultural biotechnology, precaution should be limited when potential negative impacts can be either ruled out or deemed unlikely enough to fall below the level of risk deemed acceptable for any other product. Further, in developing regulations, decision makers should take into account that “inaction and delay also incur consequences. The risks of inaction must also be identified and taken into consideration,” as a group of conservation scientists and practitioners state in a 2021 issue of the journal Conservation Science and Practice entitled “Intended Consequences.” Indeed, as Sarah Garland argues in Global Food Security, “Climate change is the key context necessary to reinterpret the scientific risk evaluated by the Precautionary Principle.”

If we are to really weigh the risk of biotechnology in agriculture, it must not be against a neutral or stable status quo, but against the risk of inaction—climate-vulnerable agriculture, worsening food insecurity, fertilizer pollution, and more.

The path to sensible regulations

Even though microbes have already been applied to plants and soil in agriculture and gene-edited microbes have been in development for years, there is still no guidance for regulating them in the US. Given the potential benefits of gene-edited microbes and the rapid pace of innovation, a regulatory approach must be developed as soon as possible. The SECURE rule for the regulation of plant biotechnology in agriculture was finalized two years ago, but the first biotech crops have only just made it through the Regulatory Status Review process. Before that, it took decades after the first regulations for biotech crops in the US were instituted until a revised SECURE rule was passed in 2020, and we cannot afford to wait that long again.

There are some clear paths forward. For one, there are some gaps in the peer-reviewed literature in areas that regulators need to draw on for risk assessment, and filling them could help speed up the regulatory process.

As part of the USDA review process of biotech plants under the SECURE rule, applicants must submit existing literature and unpublished studies and data to support their claims about the absence of certain risks of their product. This process is relevant to the regulation of gene-edited microbes, because, as part of this work, applicants conduct studies to measure the ability of the microbes they develop to spread in the environment. This data is largely not publicly available. If it were, though, gene-edited microbe developers could reference it in their applications to USDA, saving them time by reducing the tests they need to do themselves. It could save the USDA time, too, because the regulators wouldn’t need to review new evidence on microbial spread in the environment with every application.

There are a couple of options for building this evidence base: first, companies developing gene-edited microbes could pool their resources or agree to publish results of trials with non-proprietary strains of the microbes they use; second, a third party could conduct and publish this research in peer-reviewed literature to benefit overall development and commercialization of gene-edited microbes in agriculture. The USDA helps fund research like this that advances risk assessment abilities for biotech products through the Biotechnology Risk Assessment Research Grants Program (BRAG). Funding for 2023 applications totals about $5.5 million, and awards range from $25,000–$650,000. Funding for these grants and staff for this program should scale up as biotechnologies like gene editing are increasingly used to develop microbes for agricultural use, as well as crops and livestock.

Breeders and researchers have sufficient knowledge and ability to create intended traits through both conventional breeding and biotechnology, and the risk of unintended consequences is low. Policymakers must weigh the risks of biotechnology in agriculture against the risks of inaction, rather than against a neutral or stable status quo. And foregoing the use of powerful tools and solutions risks missing out on a future of climate-resilient agriculture and food security.