New Competition Era for Gene-Edited Crops and the Positive Shift on GM Crops: An Overview on Global Regulatory Changes

The global food security system has been threatened by many challenges, such as the lingering COVID-19 pandemic for three years, frequent extreme weather events, and the Russia-Ukraine conflict, the most significant ‘black swan’ in 2022. 

Increasing uncertainties make ″how to build a more resilient food supply system″ the hottest topic of the day.

As the most potential important force to promote the disruptive development of agriculture, agricultural biotechnology is again in the spotlight. In addition to the gene editing technology, which is highly favored because it can precisely change specific traits by ″editing″ gene fragments without introducing exogenous genes and overthrow the traditional breeding path and selection efficiency, the agricultural genetically modified (″GM″) technology, which has been controversial due to uncertain food safety issues, is showing rare signs of being accepted to a greater extent.

 Gene-edited crops

Pushing the boundaries of plant breeding

Gene editing technology, which won the Nobel Prize in 2020, is hailed as a revolutionary breakthrough in the life sciences in the 21st century. It has been applied in many countries, showing broad prospects in scientific research, agriculture, clinical medicine and other fields. In recent years, gene editing technology, represented by CRISPR-Cas9, has become an important tool for gene function analysis and variety creation, constantly increasing the precision and efficiency of crop breeding.

Globally, gene editing technology has been widely used in crops such as rice, corn, soybean, wheat and tomato, and gene-edited products such as waxy maize, high-oleic soybean, non-browning potato, GABA-enriched tomato, non-browning mushrooms have been commercialized in the U.S., Japan and other countries.

Difference exists in mainstream regulatory models

The prerequisite for the commercialization of a product is the availability of regulatory policies. However, currently, there exist regional disharmonized regulations and policies for gene editing. According to a study by LENG Yan, et al. at the University of Science and Technology Beijing^[1], governments of various countries adopt different regulatory measures in applying crop gene editing technology, and no consensus has been reached yet. 

Generally, regulatory models can be divided into three categories: first, the lenient model represented by the United States (US). and Argentina, which is of product-oriented regulation; second, the cautious model represented by most EU countries, which is of process-oriented regulation and considers gene-edited crops to be substantially equivalent to genetically modified (GM) crops; and third, the eclectic model represented by Australia, and countries adopting this model adjust corresponding regulations and technical measures according to the economic and technological development stages in the regulatory process of gene-edited crops.

In the U.S., crop-related gene editing is jointly regulated by the USDA, the U.S. Food and Drug Administration, and the U.S. EPA. In 2020, the Federal Register published a new policy, stating that, if researchers use gene editing to design a plant that could have been bred conventionally, the new plant will be exempt from regulation. Currently, the USDA has exempted from GMO regulation various products designed with gene editing technology, such as SDN-1 and SDN-2 type corn, canola, mushrooms, and false flax.

The EU continues its rigorous approach to the regulation of gene-edited crops. In a ruling of 2018, the Court of Justice of the European Union ruled that gene editing techniques such as CRISPR-Cas9 should be included in existing regulatory rules for GM crops, aiming to strictly control genetic modification methods that transfer genes between different species. However, according to a report by Reuters on February 7, 2023, the European Supreme Court announced that in-vitro plant gene editing techniques used conventionally and with a long safety record are excluded from EU laws restricting the use of genetically modified organism (GMOs). The resolution largely relaxes regulatory restrictions on gene editing in areas such as agriculture.

Australia was one of the early adopters to introduce and plant GM crops, and its biotechnology regulation has been somewhere between the U.S. and the EU. The Gene Technology Act the country adopted the regulation of gene-edited crops. When the Act was revised for the third time in 2019, it provided that gene editing techniques not introducing exogenous genes for use in plants will no longer be regulated.

Policies change in response to seed industry competition

Compared with GM technology, gene editing technology is newer and has broader prospects. Furthermore, unlike GM technology, gene editing technology has less pressure from the public. Therefore, it is regarded as a new development direction for seed industry competition by many countries, especially developing countries. This can be evidenced by changes in regulatory policies of some countries in recent two years.

The first one worth mentioning is the UK. After the completion of Brexit, the UK has more room to extricate itself from the EU restrictions on agricultural biotechnology. In June 2022, the British government proposed a new bill to Parliament, with the intention of relaxing the regulations on gene-edited crops.

In China, the Guidelines for Safety Evaluation of Gene-Edited Plants for Agricultural Use (Trial), released in January 2022, regulate the management of safety evaluation of gene-edited plants. The industry sees the introduction of this policy as a sign to break the previous situation of ″leading research, lagging management and blank application″ of gene editing technology in China. According to the information from the database of the European Sustainable Agriculture Through Genome Editing organization (EU-SAGE), China and the U.S. lead the world in the research of gene-edited crops.

Figure 1: Countries where GE studies were conducted

(Source: EU-SAGE)

In March 2022, the Ministry of Environment, Forest and Climate Change of India revised its rules concerning gene editing applications in agriculture, stating that gene editing will be excluded from the GMO classification. This ruling will likely open the door to new techniques for plant breeding, such as CRISPR.

African countries also made particularly notable efforts in this regard. In December 2020, Nigeria became the first country in Africa to authorize, through its National Biosafety Management Agency, guidelines on gene-edited crops, stating that if edited lines do not contain a new combination of genetic material, they can be classified as conventional varieties or products. 

In February 2022, Kenya’s National Biosafety Authority published guidelines that provide the framework for exempting gene-edited organisms and products from the Biosafety Act, enabling approval on a case-by-case basis that should be classified as conventional varieties. 

Malawi, Ethiopia, and Ghana are also currently developing their policies, while South Africa is currently in an on-going appeals process after a decision to consider all gene-edited plants as GMOs.

Harmonized regulations are vital to the commercialization of gene-edited crops

According to the information from the EU-SAGE’s database, the current global research on gene-edited crops is focused on increasing yields and improving product quality^[2]. So, it is easy to understand why this technology is gaining more attention and growing rapidly at a time when global food security is a major challenge.

Figure 2: Trait categories studied using gene-editing

(Source: EU-SAGE)

A consensus is emerging that gene-edited crops are expected to meet the global food supply and contribute considerably to human health and the environment. However, from the above overview of regulatory policies of various countries and regions, it can be seen that there is no harmonization/alignment of regulations for this technology by now. If this issue is not well addressed, the industry will likely face the same trade issues that have limited the wider commercialization of GM crops.

 GM Crops

Food security crisis - a favorable turn for GM crops

According to a statement^[3] jointly issued by the Food and Agriculture Organization of the United Nations, the International Monetary Fund, the World Bank, the World Food Programme and the World Trade Organization, supply chain disruptions, climate change, the COVID-19 pandemic, financial tightening through rising interest rates and the Russia-Ukraine war have caused an unprecedented shock to the global food system. Food inflation remains high worldwide, with dozens of countries experiencing double-digit inflation. According to the World Food Programme, 349 million people across 79 countries/regions are acutely food insecure.

Against this backdrop, the GM crop industry, which has been under pressure of both regulation and public opinion, is likely to welcome a favorable turn amid global concerns about food security.

The most typical change happens in Europe, where GM crops are most heavily regulated. As hot, dry weather wreaked havoc on European agriculture last year and the impact of the Russian-Ukrainian war on the agricultural supply chain, some European politicians are starting to rethink the EU’s long-standing opposition to genetically modified and gene-edited crops. In fact, political pressure to change the current rules on GMOs has been building since 2018. Industry players want to see GM plants without ″foreign DNA″ intentionally added to their genomes excluded from EU’s GMO legislation.

China deserves high attention from domestic and foreign investors

China is mostly worth mentioning in this regard. In 2021, China launched its Seed Industry Revitalization Action Plan (″the Plan″), aiming to secure the ″chips″ of agriculture. The Plan is most favorable to the GM crop industry. Since the end of 2019, China has successively introduced rules on ″verifying the safety and effectiveness of transferred genes″, ″verifying the effect of yield and income increase by GM varieties″, ″defined and detailed management standards″, ″original innovation protection by regulations″, etc., creating a good technical and institutional basis for the liberalization of the GM seeds market.

In the past year, over RMB3 billion capital was poured into the seed market, and several Chinese seed companies rang the bell for IPO. China’s biotechnology plant breeding industry ushered in its first year of commercialization. Under the background of revitalizing China’s seed industry, the commercialization of GM crops is just around the corner.

From the perspective of food trade, China imports large quantities of soybeans, corn and wheat every year, and China’s policy on GM crops affects not only the direction of food trade but also the planting plans of GM crops in exporting countries. In the past two years, China’s Ministry of Agriculture and Rural Affairs published several issues of China Imported GMOs Biosafety Certificate List, approving the import of GM soybeans, cotton, canola and other products from Bayer CropScience, Corteva, BASF, Bioceres and other companies, marking the further opening of the Chinese market.

Countries adopting favorable policies again after years of wait-and-see

At the end of 2022, the Indian Genetic Engineering Appraisal Committee (GEAC) approved the commercialization of GM mustard, bringing two positive signals to the process of genetic engineering in Indian agriculture. The first is that India’s first GM mustard variety has significant advantages in boosting its domestic mustard production and achieving self-sufficiency. The second is that the commercial release process of more GM crop varieties in India will be further advanced. Before mustard, cotton was the only GM crop approved for commercial cultivation in India.

Also, in 2022, Kenya broke its decade-long ban on GMOs and resolved to approve the cultivation and import of GM crops. The government said it had developed a strong policy, legal and institutional framework to promote the safety of GMOs. The same year, the Philippine government approved the commercial cultivation of Bt eggplant, becoming the second country after Bangladesh to allow commercial cultivation of moth-resistant Bt eggplant. Bangladeshi regulators agreed last year to introduce transgenic Bt cotton in the country. Once introduced, Bt cotton will be Bangladesh’s second GM crop after Bt eggplant was introduced in 2013.

Milestone progress for the commercialization of GM wheat 

In Argentina, GM wheat developed by Bioceres Crop Solutions has achieved a series of progress in commercialization. In 2020, Bioceres Crop Solutions’ drought-resistant GM wheat (event: HB4) received approval for consumption or processing and commercial cultivation from Argentina’s Ministry of Agriculture. Argentina is the largest wheat producer in Latin America and the first country worldwide to adopt HB4 drought tolerance technology in wheat. According to Bioceres, the HB4 trait can increase wheat yields by 20%, and it is currently the only drought-tolerant technology used in wheat and soybeans in the world.

In 2021, Brazil, a country that purchases over 85% of its wheat from Argentina, approved HB4 wheat flour for animal and human consumption, clearing the way for the cultivation and commercialization of HB4 wheat. In 2022, HB4 wheat successively received approvals for food and feed use from Colombia, Australia and New Zealand, the U.S., Nigeria and South Africa. Approvals are pending from Uruguay, Paraguay, Chile, Bolivia, and Indonesia.

Until HB4 wheat was approved in Argentina, wheat has historically been an ″orphan crop″ in the area of biotechnology, despite being planted in 200 million hectares globally, the largest of any crop. Argentina is Latin America’s largest wheat producer, accounting for approximately 70% of wheat produced in this region. Currently, drought-tolerant HB4 wheat is the only GM wheat approved and commercialized globally, which represents a major milestone in wheat’s global value chain.

References:

[1] LENG Yan, SUN Kang Tai, et al. Trends of Global Gene-edited Crops Supervision. China Biotechnology, 2021, 41 (12): 24-29

[2] Michael G. K. Jones, John Fosu-Nyarko, etc. Enabling Trade in Gene-Edited Produce in Asia and Australasia: The Developing Regulatory Landscape and Future Perspectives. Plants 2022, 11(19), 2538; https://doi.org/10.3390/plants11192538

[3] Joint Statement by the Heads of the Food and Agriculture Organization, International Monetary Fund, World Bank Group, World Food Programme and World Trade Organization on the Global Food and Nutrition Security Crisis. 

If you are interested in the topic of gene-edited crops and GM crops, feel free to write to the author for further communication.  christina@agropages.com

This article was initially published in AgroPages' 'Annual Review 2022' magazine.