If CRISPR crops can avoid being regulated like GMOs, they can create significant opportunities for low- and middle-income countries, and help combat hunger and poverty.
Genetically modified (GMO) farm crops are engineered with DNA from other organisms, making them “transgenic.” They have been blocked from widespread use over the past two decades due in part to a basic disagreement over how they should be regulated. Despite scientific consensus on the safety of transgenic (rDNA) methods, European policies added a new layer of regulatory restrictions for GMO crops, making them difficult plant or sell. When a majority of other governments followed suit, the uptake of GMO food crops in particular was widely blocked. Now, crop science is taking another novel step forward. A new genome editing method first mastered in 2012, called Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), can precisely alter crops at the molecular level without introducing genes from other organisms. If these CRISPR crops can avoid being regulated like GMOs, they might create significant opportunities for low- and middle-income countries (LMICs) and help combat both hunger and poverty. 1
GMO Regulations Limit Crop Uptake, Establish Harmful Precedent
In 1986, anticipating the development of transgenic GMO crops, the United States decided to test and regulate them narrowly, according to their potentially harmful traits such as toxicity, allergenicity, and negative impacts on the environment. The final product, not the process of development, would remain the regulatory focus. The European Union took a different approach, focusing also on the method of development and legislating an added layer of regulatory restriction for crops that were transgenic, with “foreign” DNA.
Europe’s decision to create these added regulations was not enough to reassure ordinary citizens, who were being told the new crops might be dangerous. In fact, the stronger regulations only heightened popular suspicion of threat. The only way to calm such fears in Europe was to ramp up the new restrictions to keep GMO foods and crops out of supermarkets and farm fields entirely. This was accomplished through a burdensome series of regulatory requirements: GMO crops would require pre-market approval on a case-by-case basis, and would have to be segregated from conventional crops in the field and separately labeled. Operators in the marketplace must then maintain an audit trail “tracing” where each GMO came from and where it went for five years. GMO crops would also be subject to “strict liability,” meaning developers and growers would be vulnerable to legal action if anything went wrong, even if they had played by the rules. 2 When regulators in most Asian and African countries decided to follow some version of this European approach, the United States, with its more permissive view of GMOs, became a global outlier.
The wide global adoption of European-style GMO crop regulations limited the uptake of GMO food crops in particular. Industrial crops (like cotton) and crops sold primarily for animal feed (like yellow corn and soybeans) are widely grown in GMO form in some countries, but staple food crops seldom are. 3 To date, it is not legal for farmers in most countries to plant any GMO varieties of wheat, potato, white rice, or white corn.
It was ironic that these restrictions on GMO food crops took hold just as a scientific consensus was emerging—even in Europe—that the use of rDNA methods had not introduced new risks into the process of crop development. By 2004, the Royal Society in London, the British Medical Association, the French Academy of Sciences, and the German Academies of Science and Humanities had all declared, in writing, they found no convincing evidence of any new risks to either human health or to the environment from any of the GMO crops that had been developed for the market. Even the European Union Commission agreed with this conclusion. In 2010, the Research Directorate of the European Union conducted an analysis of more than 150 projects the European Union funded over two decades, and concluded that, “biotechnology, and in particular GMOs, are not per se more risky than e.g., conventional plant breeding technologies.” 4
Is GMO History Repeating itself with CRISPR Crops?
Gene editing cuts the strands of a plant’s own DNA at a specific location to either “knock out” or amplify genetic traits. This should make CRISPR crops less controversial than transgenic GMOs, because they do not have to contain “foreign” DNA from another organism. They strongly resemble common mutations found in nature, and the use of mutations to breed new crops has traditionally been exempted from separate regulation, even in Europe.
Nonetheless, civil society organizations that had earlier organized to block GMOs began working immediately to block gene-edited crops as well, attempting to brand them “GMO 2.0.” They asserted that the new method would bring new risks, such as “off-target mutations,” even though genome editing-methods like CRISPR are precise and appear to generate non-target mutations at a similar frequency to natural mutations. 5 The fact that mutations are a natural process, plus the fact that most gene-edited crops do not have any DNA from other organisms, should make them even less prone to new risks than rDNA crops.
But when the French government used this logic to pass a law exempting gene-edited crops from the regulations imposed on GMOs, an alliance of civil society organizations, including Friends of the Earth, brought a lawsuit. The case went to the European Court of Justice, which ruled in 2018 that gene-edited crops would have to be regulated like GMOs inside the European Union. This will subject them to the same onerous rules that had kept transgenic GMO food crops out of farm fields in Europe, and in other countries that follow Europe’s regulatory lead. Perhaps genome-edited crops could now be commercially blocked as well.
Not likely, as it turns out. Regulators around the world are deciding not to repeat the earlier mistake. Instead of following Europe this time, most countries are moving to exempt gene-edited crops from GMO regulations, so long as they contain no “foreign” DNA. The countries that have moved in this direction so far include Sweden, the UK, Argentina, Chile, Brazil, Canada, Japan, South Korea, Australia, the Philippines, China, India, and several leading countries in Africa.
China, which still hasn’t commercialized transgenic rice, corn, or soy, is going full speed ahead with genome editing. By 2018, China had nearly as many CRISPR patent applications and published scientific papers on CRISPR as the United States. Chinese scientists have learned how to silence a gene that restrains kernel production in corn, resulting in a 10 percent increase in yield. 6 Eager to capture such benefits, China’s Ministry of Agriculture and Rural Affairs released preliminary guidelines early in 2022 that exempted gene-edited crops from GMO regulations, so long as they had no “foreign” DNA.
In India, at least seven institutes and universities have recently been using gene-editing to improve rice, banana, groundnuts, wheat, soybean, and maize. India still declines to plant any significant transgenic GMO crops other than cotton, but in 2020 its National Academy of Agricultural Sciences recommended that gene-edited crops without foreign DNA should be exempt from GMO regulations.
In Africa, both Nigeria and Kenya have now published guidelines for their scientists working with CRISPR, indicating that crops and animals with no foreign DNA will probably not be regulated as GMOs. Kenya’s Biosafety Authority has even granted approval to seven different gene-editing research projects.
Why LMICs are Attracted to CRISPR Genome Editing
LMICs that followed Europe’s lead when regulating transgenic crops are taking a more permissive approach to genome editing for good reason. They see gene editing as more valuable because it is faster and cheaper than transgenic methods. According to one 2019 estimate, the cost of getting non-GMO gene-edited crops to the market is likely to be less than half as high, and the time only one third as long compared to GMOs. 7 Because gene-editing is faster and cheaper, it can affordably be employed on the “orphan crops” that are planted only by poor farmers in LMICs. CRISPR gene editing will also, for this reason, be easier to develop outside of deep pocketed corporate labs. In Argentina, while 90 percent of transgenic GMO crops were developed by large multinational corporations, only nine percent of gene-edited crops so far have come from such companies. 8
The fact that gene edited crops have no foreign DNA and do not have to come from large profit-making companies will also make them much easier for farmers and consumers to trust. In addition, they are less likely to be locked up in patents. In September 2021, Wageningen University in the Netherlands, a world leader in agricultural research, announced it would waive its patent rights on CRISPR technologies for non-commercial use to help get these technologies more quickly into the hands of the poor. 9 Such efforts to deploy CRISPR technology more equitably present opportunities for LMICs to improve their agricultural technology, helping reduce financial and technological disparities that trap countries in cycles of poverty. 10
CRISPR gene editing in farming can also help mitigate adverse effects from climate change. LMICs are disproportionately impacted by climate change as they increasingly face weather variability, shifting agroecosystem boundaries, and increasing temperatures, 11 which puts farmland and harvests at risk. CRISPR gene editing can make crops more resilient to climate variability, while also helping to limit greenhouse gas emissions from agriculture. 12 By developing crops capable of higher yields in deleterious climate conditions, CRISPR provides new opportunities for LMICs to preserve farmland as well as address food insecurity and reduce rural poverty.
CRISPR gene editing will offer substantial opportunities for agricultural growth, especially for LMICs. However, when governments use a “no foreign DNA” excuse to clear the way for gene edited CRISPR crops, it will only harden today’s harmful regulatory bias against transgenic GMO crops, leaving this earlier crop improvement method even more seriously hampered. It would be better to clear the regulatory path for both gene-edited and transgenic crops by moving entirely away from DNA-based process standards, focusing instead on standard and more narrow risk assessments of the final product.
- 1CRISPR gene editing can bring substantial benefits beyond farming, including in human medicine, but some of these applications raise significant ethical concerns. Gene editing has the potential to create human sub-populations with inherited resistance to some diseases or conditions, a beneficial outcome for some, but one that could undermine social equity and should thus require a higher standard of informed social consent.
- 2Bruetschy, Chantal. “The EU Regulatory Framework on Genetically Modified Organisms (Gmos) - Transgenic Research.” SpringerLink. Springer International Publishing, July 18, 2019. https://link.springer.com/article/10.1007/s11248-019-00149-y.
- 3Paarlberg, Robert, and Ronald Herring. “The Political Economy of Biotechnology.” Annual Reviews, October 2016. https://www.annualreviews.org/doi/10.1146/annurev-resource-100815-095506.
- 4“A Decade of EU-Funded GMO Research (2001-2010).” Office of the European Union. Publications Office of the European Union, November 11, 2010. https://op.europa.eu/en/publication-detail/-/publication/d1be9ff9-f3fa-4f3c-86a5-beb0882e0e65.
- 5Podevin, Nancy, Howard V Davies , Frank Hartung, Fabien Nogué, and Josep M Casacuberta. “Site-Directed Nucleases: A Paradigm Shift in Predictable, Knowledge-Based Plant Breeding.” Trends Biotechnol. U.S. National Library of Medicine, June 2013. https://pubmed.ncbi.nlm.nih.gov/23601269/.Huang, Sanwen, Detlef Weigel, Roger N Beachy, and Jiayang Li. “A Proposed Regulatory Framework for Genome-Edited Crops.” Nature News. Nature Publishing Group, January 27, 2016. https://www.nature.com/articles/ng.3484#citeas.
- 6Houser, Kristin. “7 Ways CRISPR Is Shaping the Future of Food.” Freethink, November 9, 2022. https://www.freethink.com/science/crispr-food.
- 7Lassoued, Rim, Diego Maximiliano Macall, Hayley Hesseln, Peter W. B. Phillips, and Stuart J. Smyth. “Benefits of Genome-Edited Crops: Expert Opinion - Transgenic Research.” SpringerLink. Springer International Publishing, March 4, 2019. https://link.springer.com/article/10.1007/s11248-019-00118-5.
- 8Whelan, Agustina I, Patricia Gutti, and Martin A Lema. “Gene Editing Regulation and Innovation Economics.” Frontiers. Frontiers, March 20, 2020. https://www.frontiersin.org/articles/10.3389/fbioe.2020.00303/full.
- 9Van der Oost, John, and Louise O Fresco. “WAIVE CRISPR Patents to Meet Food Needs in Low-Income Countries.” Nature News. Nature Publishing Group, September 6, 2021. https://www.nature.com/articles/d41586-021-02397-7#:~:text=Wageningen%20University%20%26%20Research%20announced%20this,production%20sustainable%2C%20nutritious%20and%20safe.
- 10CRISPR can also help improve animal welfare, specifically through avoiding the slaughter of billions of male chickens each year by preventing the development of male embryos.
- 11“Climate-Smart Agriculture.” World Bank. Accessed November 30, 2022. https://www.worldbank.org/en/topic/climate-smart-agriculture.
- 12Sanders, Robert. “In 10 Years, CRISPR Transformed Medicine. Can It Now Help Us Deal with Climate Change?” University of California, September 13, 2022. https://www.universityofcalifornia.edu/news/10-years-crispr-transformed-medicine-can-it-now-help-us-deal-climate-change#:~:text=%E2%80%9CCRISPR%20can%20play%20a%20role,Brad%20Ringeisen%2C%20IGI%20executive%20director.