After they were introduced in the mid-1990s, GMO crops were met with a buzzsaw of regulations and skepticism because they involved the transfer of genes between species, thus giving rise to concerns of potential health hazards to humans and animals and harm to the environment. These concerns were never given validity by any scientific evidence.
There has never been one reported instance of harm caused to humans by eating GMO foods. Nevertheless, opponents of GMOs were able to manufacture concerns and distrust which slowed their acceptance among the public. In addition, the heavy hand of regulation that most countries imposed on GMOs boosted the cost of research and development and deterred their cultivation. As a result, GMOs were largely developed by large agri-business multinationals for a few major crops such as corn, sugar beets and soybeans with Bayer (which owns Monsanto), Corteva (formed via the merger of the agribusiness divisions of Dow and Dupont) and Syngenta (a Swiss company that was purchased in 2015 by China National Chemical Corporation) dominating the GMO seed market. This has led to charges that GMOs are controlled by an oligarchy of giant multinationals who have developed biotechnology crops that are not in the interest of consumers but instead are in the interest of large farmers.
New Plant Breeding Technologies, particularly gene-editing tools such as CRISPR, are generally coming under less government scrutiny and regulation because they are perceived as being less potentially dangerous since the changes that occur mimic mutations that could happen naturally. Also, the changes are not a product of the transference of DNA between species which sparked unwarranted concerns that GMOs were an “out of control” science experiment that could create unintended consequences.
Reduced regulation and cost of entry has resulted in a plethora of new companies entering the gene-editing crop field. They are involved in researching and developing new and innovative foods such as:
- Cayxt’s heart healthy high oleic low linolenic soybean oil.
- Cibus is working on developing weed, disease and insect resistant rice that is Nitrogen Use Efficient.
- Yield 10 Biosciences is working to increase the yields of canola and soybeans, and increase the oil content of these and other oilseeds.
- Pairwise is developing seedless blackberries, pit-less cherries and more nutritious lettuce.
This lighter touch of government regulation for gene-editing is occurring at a time when GMOs are becoming more acceptable and being adopted by a growing list of developing countries. Perhaps the most important recent development was the decision by China to approve new regulations to set out a clear path for the approval of GMO crops.
China’s commercialization of GMOs
Since 1997, China has commercialized six GMO products; cotton, tomato, sweet pepper, petunia, poplar, and papaya, but only papaya and cotton are currently in commercial production.
The decision to accelerate the commercialization of GMOs was prompted by the realization that hesitancy towards GMOs was stifling the seed industry, the need to reduce dependency on foreign imports of food, particularly corn and soybeans, which are used extensively as animal feed, and the need to increase food production to reflect the growing affluence of the population. Under the new regulations, if a GM trait has been approved as safe by the Agriculture Ministry, it only requires a one-year production trial to verify its safety. Production of GMO corn is expected to begin sometime in 2023.
On January 25, the Chinese government issued draft rules that reduced regulations for gene-edited crops. The new rules stipulate that once gene-edited crops have completed pilot trials, a production certificate can be applied for. As a result, gene-edited crops could take only a year or two to get formal approval. Although no gene-edited crops have been commercialized, Chinese scientists have conducted extensive research in the field, and China’s research institutes have published more research reports on gene-edited crops than any other country.
Developing countries catching the GE wave
Despite a well-funded campaign by anti-GMO and anti-GE advocates to spread dis-information more and more nations, particularly developing countries, are adopting GE crops:
- In 2012, Sudan began growing GMO cotton.
- In 2014 Bangladesh began growing insect resistant Bt brinjal (a variety of eggplant).
- In 2015 Vietnam began cultivating GMO corn.
- In 2018 eswatini (formerly Swaziland) began planting GMO cotton.
- In 2019, Ethiopia commercialized GMO cotton.
- In 2020 Nigeria, Malawi and Kenya started growing GMO cotton.
- In December 2020, Cuba began planting GMO corn.
In 2021, Nigeria started growing GMO insect resistant cowpeas and is currently conducting confined field trials for GM insect-resistant and drought-tolerant corn, bio-fortified Sorghum, Virca Plus Cassava (resistant to Brown Streak Disease) and Nitrogen-and Water-Use Efficient and Salt Tolerant rice.
Kenya has authorized the approval of field performance trials for a disease resistant cassava and will begin growing GMO corn this year. Ghana is likely to follow Nigeria and approve the growing of GMO cowpeas in 2022. Two required regulatory field trials have been successfully concluded in Ghana for Nitrogen Use Efficient Rice.
The USDA Biotechnology Report for Indonesia for December, 2021, noted, “to date, 20 GE corn, 14 GE soybean, three GE sugarcane, one GE potato, four GE canola, and five GE cotton varieties have undergone risk assessment for either food, feed, or environmental safety. Of these, a GE sugar cane variety, has undergone all three assessments. The GE sugar cane developed by state-owned PT Perkebunan Nusantara XI, is the first GE crop to meet all existing regulatory requirements for public release.” A GE blight resistant potato is expected to be commercialized by 2025.
In 2021, the Philippines approved the cultivation of golden rice, which enhances the vitamin A content of the crop, thus helping to reduce the health problems associated by an insufficient amount of Vitamin A in the diet. Bangladesh is expected to follow the Philippines and approve the growing of golden rice in the near future. In addition, it is conducting research and field trials for disease resistant potatoes, tomatoes and wheat and insect resistant cotton (Bt).
On March 24, 2021, Vietnam issued a Master Plan outlining the development of agricultural biotechnology to 2030. According to the USDA biotechnology report for Vietnam, the plan calls for the facilitation of “research and application and of biotechnology in a group of key agricultural products to increase quality and productivity, adapt with climate change, and resist pests and disease; increase investment in local agricultural biotechnology industries; and upgrade capacities in plant breeding technologies, gene technologies, and animal and plant cell technologies.” The plan also sets objectives in “applying gene technologies, plant cell technologies and new technologies to create new varieties with high-quality, high-yield, climate-resilient and disease-resistant traits for key crops.”
With some exceptions, the countries that cultivate GMOs have adopted a lighter brush of regulations for gene-edited crops while those that do not grow GMOs have shut the door on gene-edited crops.
Policy of highest producers of GMO crops to gene-editing
United States
The largest grower of GMOs is the United States which accounted for 37.6% of all acreage in 2019. In March of 2018, the USDA issued a statement that said, “Under its biotechnology regulations, USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests. This includes a set of new techniques that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods. The newest of these methods, such as genome editing, expand traditional plant breeding tools because they can introduce new plant traits more quickly and precisely, potentially saving years or even decades in bringing needed new varieties to farmers.”
USDA Secretary Perdue, said “Plant breeding innovation holds enormous promise for helping protect crops against drought and diseases while increasing nutritional value and eliminating allergens. “
Brazil
Brazil, the second largest grower of GMOs, Argentina, the third largest and Paraguay, the sixth largest have adopted a policy in which gene-edited crops and food are regulated as conventional plants unless they contain foreign DNA.
Canada
Canada is the fourth largest grower of GMO crops. On May 18, Health Canada issued new guidelines regarded genetically engineered crops which essentially deregulate them. Under the new regulation regime Health Canada “will no longer regulate or conduct safety assessments for foods produced from genetically edited plants unless they contain foreign DNA.” With regards to concerns about the possible health and environmental impact of gene-edited crops, Health Canada said, “There’s a consensus that the use of gene editing technologies doesn’t present any unique safety concerns compared to other more conventional methods of plant breeding. As such, Health Canada should regulate gene-edited products of plant breeding in the same manner as all other products of plant breeding.” The new regulations will mean that crops produced via gene-editing technologies will be considered to be safe and will not require a pre-market safety assessment. GMO crops however will still require pre-market approval.
Commenting on the decision, Rick White, chair of the Canada Grains Council, said, “This will open up the very real possibility of dramatic improvements for small- and large-acre crops alike, from productivity improvements to new solutions for emerging pest pressures to advances in food and fuel crops that will benefit the entire value chain including consumers.”
India
India is the fifth largest growing of GMO crops all of which are Bt cotton. There have been attempts to widen the scope of GMO crop production by growing GMO mustard and Bt brinjal but a strong and vocal anti-GMO movement in India has made it impossible to sanction the cultivation of additional GMO crops. A draft proposal that would regulate gene-editing crops similar to conventionally bred crops was pending with the Genetic Engineering Appraisal Committee for over two years before being largely approved by the government at the end of March. Under the terms of the new regulations, genome edited plants or organisms that do not contain any foreign DNA will not be subjected to the same biosafety standards as genetically modified crops and they will no longer be regulated by the Genetic Engineered Appraisal Committee.
Public Research laboratories in India are conducting gene-editing research to develop nutritionally improved oil seeds, drought tolerant rice and corn, a beta-carotene banana, high oleic and low linoleic acid ground nuts, blast-resistant rice, high yielding rice that is nitrogen and water use efficient and anthracnose (a fungal disease) resistant pepper.
China
China, the seventh largest growing of GMO crops, has, as indicated, recently taken measures to relax regulations of GMOs and gene-edited crops to encourage their development.
South Africa
South Africa is the eight largest grower of GMO crops. It however has decided to regulate gene-edited crops as if they were GMOs which is likely to slow down their development.
And then there’s the European Union
Expectations on the part of scientists that the EU would adopt a more friendly attitude towards gene-edited crops were dashed by a ruling by the European Court of Justice (ECJ) in 2018 that placed them under the same harsh regulatory procedures that have stifled the development of GMO crops. Many scientists were confounded by the ruling as it was contrary to the consensus of the scientific community that gene-editing is a safe and effective means of altering the DNA of a plant and thus did not require heavy handed regulation. The ECJ decision also went against the growing trend in the world of applying the same guidelines and standards to gene-edited crops that apply to conventionally grown crops.
Anti-GE organizations, which are highly influential in the EU, strongly applauded the decision. Greenpeace EU’s food policy director, Franziska Achterberg, said
the court’s ruling had prioritized the protection of human health and the environment. Releasing these new GMOs into the environment without proper safety measures is illegal and irresponsible, particularly given that gene-editing can lead to unintended side effects. The European commission and European governments must now ensure that all new GMOs are fully tested and labelled, and that any field trials are brought under GMO rules.
Recognizing the potential benefits of gene-editing for crops, the EU has recently tried to leave open the possibility of revisiting in the future a more favorable ruling for gene-edited crops. A May 2021 EU Commission report for example, recommended updating EU legislation to allow the use of gene-editing. The report noted that CRISPR can help make food production more sustainable, create plants that are resistant to diseases and hasher environmental conditions that may result from climate change and that do not require pesticides and fungicides.
From a practical standpoint however, it will be very difficult to change the regulation approval regime for gene-edited crops for a number of reasons.
- First, any change would need the approval of all member states, the EU Council and the European Parliament. There is however no consensus among the EU states to change the regulations. Only Spain and Portugal grow a relatively small amount of GMO corn while most of the other EU countries have an outright ban of cultivating GMO crops. No country meanwhile has produced a gene-edited crop.
- Second, changing the regulations would be met with public pushback as there is great deal of antipathy in the EU to any form of genetic engineering of food. A 2020 Pew Research World Survey on attitudes towards GMOs reported that 67% of Poles, 62% of Italians, 54% of the French, 53% of Czechs, 48% of Germans and 47% of Spaniards who were surveyed believed GMOs were unsafe. Only a small fraction believed they were safe with most of the remainder saying they did not know enough to make a judgment. The least skeptical were the Dutch. Only 29% of those asked said GMOs were unsafe. It should be noted though that 50% of the Dutch surveyed said they did not know enough to make a judgment.
- Third, many of the political parties in Europe, particularly the Green Parties, are strongly opposed to GE food. This is especially the case with the Green party in Germany, which is the third largest political party and is part of the governing coalition that includes the Free Democrats and the Social Democrats.
In their party platform for the 2021 elections, the Green Party said, “Our guiding principle is further developing ecological agriculture with its principles of animal justice, freedom from genetic engineering and freedom from chemical-synthetic pesticides…we want to advance the breeding of robust varieties and research into organic seeds, as well as strengthen research into alternative approaches that rely on traditional and organic breeding methods.” With respect to old and new genetic engineering methods, the Greens pledged to “adhere to a strict authorization procedure and the precautionary principle anchored in European law” and called for “continued binding labelling that protects GMO-free production and consumers’ freedom of choice. Accordingly, risk and detection research need to be strengthened.”
The Social Democrats, who became the largest political party in Parliament in the 2021 election, ran on a platform of, “We will continue to say no to genetically modified plants”, while the Left party, which won 9.6% of the vote, adopted a platform that was anti-genetic engineering calling for a ban on the cultivation, trade and import of GMOs.
Antipathy to GE for crops is embedded in the German bureaucracy and as such will be very difficult to dislodge. The Federal Office for Nature Conservation, which is a division of the Environment Ministry, for example funds the Expert Office of Genetic Engineering and Environment, which is dominated by people who are opposed to genetic engineering and sympathetic to anti-GMO NGOS such as Testbiotech, Genethisches Netzwerk and Save our Seeds.
Testbiotech, one of the most influential anti-GE organizations in Germany, is opposed to gene-editing. A report paper put out by the group said,
The technical potential of New GE can be used to achieve profound changes in the biological characteristics of organisms without introducing any additional DNA sequences. These changes can exceed the range of characteristics developed gradually through evolution or previous breeding methods. It is obvious that specific risks are connected to these organisms…Risks associated with the release or usage of the genetically engineered organisms for food production need to be thoroughly examined in every case. If strict regulation of New GE is not in place, the uncontrolled release of large numbers of organisms with characteristics not gradually developed through evolution can be expected within a short period of time. This would result in the substantial likelihood of damage to ecosystems, agriculture, forestry and food production. Without sufficient regulation of New GE, Testbiotech warns that severe damage to biological diversity is likely; risks to food production may be introduced and accumulate unnoticed; access to data needed for risk assessment by independent experts will not be made available; no measures can be taken against the uncontrolled spread of the organisms in the environment; no data will be available to track and trace the New GE organisms and products derived thereof; agriculture and food production relying on GE free sources can no longer be protected.
As Germany is the largest economy and the most populous nation in the EU, its opposition would make any change in the regulations of gene-editing virtually impossible.
- Fourth, there is an active and very influential anti-genetic engineering movement in the EU which opposes any relaxation of regulations. In a report, entitled, “Danger ahead: Why gene editing is not the answer to the EU’s environment challenges, issued in March 2021, Greenpeace warned “that the use of so-called gene (or genome) editing techniques like CRISPR-Cas could not only exacerbate the negative effects of industrial farming on nature, animals and people, but it could effectively turn both nature and ourselves (through the food we eat) into a gigantic genetic engineering experiment with unknown, potentially irrevocable outcomes.”
- Fifth, there is a very influential organic lobby in the EU that opposes GE technology. IFOAM Europe, an international association of organic farmers, has said, “weakening the rules on using genetic engineering in agriculture and food is worrying news and could leave organic food system unprotected.”
- Finally, instead of promoting modern biotechnology solutions for the agriculture sector that could boost productivity, efficiency and create crops that are disease, insect, browning and drought resistant, more nutritious and potentially create their own nitrogen, the EU has decided to effectively turn back the clock and rely more on organic farming and reduced use of fertilizer. These are among the main tenets of the farm to fork (F2F) strategy that the EU unveiled in 2020 in order to help achieve the goals of agricultural sustainability, promoting biodiversity and carbon neutrality by 2050.
Among the specific targets for 2030 are reducing the use of chemical pesticides by 50%, lowering fertilizer use by 20% and increasing the share of agricultural land devoted to organic farming to at least 25%. According to the farm to fork strategy report,
There is an urgent need to reduce dependency on pesticides and antimicrobials, reduce excess fertilization, increase organic farming, improve animal welfare, and reverse biodiversity loss.
It should be noted that the F2F strategy is not a specific piece of legislation but instead is an outline for a future food system. As a result, the strategy report was not accompanied by an environmental or economic impact statement nor was there any public consultation. Although the European Parliament did vote decisively in favor of the strategy in October 2021 with a majority of 452 of the 699 members, the vote had no legislative value.
By 2023, the European Commission is expected to present a proposal for a legislative framework for sustainable food systems that will set common definitions and requirements for all actors in the food system. There are 37 different measures in the strategy that range from avoiding “marketing campaigns advertising meat at very low prices”, supporting the reduced dependence on long-haul transportation to deliver food, developing an integrated nutrient management action plan to address nutrient pollution at the source and increase the sustainability of the livestock sector.
As can be expected, the F2F strategy was warmly welcomed by the organic food industry. The Organic Processing and Trade Association European President, Stefan Hipp, said,
We all know that we have to enhance our relationship with nature to fight climate change and restore biodiversity, quality of water and soil fertility. The organic sector has been fighting for these purposes for many years. I think for all pioneers in organic farming, processing and trading this Farm to Fork strategy is a recognition of the contribution they bring to the tables and plates across Europe.
Many of the assessments of the F2F have been highly critical because of concerns it would lead to reduced food production and drive-up food costs to consumers. Tim Cullinan, the President of the Irish Farmers Association, said,
the Farm to Fork and Biodiversity strategies are unrealistic and will make European farming uncompetitive…It is not credible for the EU to drive up production costs for European farmers while at the same time looking for low food prices. They want food produced to organic standards, but available at conventional prices.
The USDA performed a number of simulations on the impact of the F2F strategy and concluded, “Under all these scenarios, we found that the proposed input reductions affect EU farmers by reducing their agricultural production by 7 to 12 percent and diminishing their competitiveness in both domestic and export markets. Moreover, we found that adoption of these strategies would have impacts that stretch beyond the EU, driving up worldwide food prices…We estimate that the higher food prices under these scenarios would increase the number of food-insecure people in the world’s most vulnerable regions.”
An analysis of F2F by Wageningen University and Research in the Netherlands, noted that,
According to the assessment at macro level, the realization of the objectives of the F2F strategies will result in a decrease of the produced volumes per crop in the entire EU on average ranging from 10 to 20%. The production volume can decline up to 30% for some crops such as apples…Prices of products such as wine, olives and hops will increase. By consequence, international trade will change significantly: EU exports were found to decline and EU imports will increase.
Potentially, the EU’s F2F policy and its opposition to genetic engineering of food threatens to create a chasm of conflict between those countries, led by the US, who want to utilize new methods of biotechnology to grow food and those, mainly the EU, who do not. The US in this regard is determined not to allow the EU to set global agricultural standards which conflict with those of the US and not to allow F2F to become a barrier hindering US agricultural exports to the EU.
To counter F2F and the EU’s anti GE stance, the US created the Coalition on Sustainable Productivity Growth for Food Security and Resource Conservation which includes Australia, Brazil, Canada, Colombia, Dominican Republic, Georgia, Ghana, Honduras, Israel, Jordan, Liberia, Mauritania, Paraguay, Philippines, Republic of North Macedonia, Turkey, United States and Vietnam.
According to the Declaration of Support statement, “We recognize that given tightening natural resource constraints, raising the productivity of existing natural resources…is the only viable option to meet food security needs of current and future generations. Only through sustainable productivity growth can we meet the world’s growing nutrition needs without bankrupting farmers, consumers, and nature.
An article in Food Policy by Robert Paarlberg highlighted some of the difficulties that the EU will face in implementing its F2F policy. It said,
With its new Farm to Fork (F2F) strategy, the EU plans to expand organic farming, an approach that rules out both synthetic chemicals and modern biotechnology, and it intends to use trade and assistance policies to pursue this strategy not just at home but also through Green Alliances abroad. The United States, by contrast, is emphasizing agricultural innovations based on the latest science—including gene-editing—and is now organizing with other countries a Coalition for Productivity Growth as a counter to European influence. Environmentalists in Europe believe their new vision is “green,” but on closer inspection it is not. If organic farming scaled up to replace 25 percent of conventional farming in Europe, much more land would have to be converted to food production, with damaging results for wildlife habitat and the climate. In its earlier rejection of GMOs, Europe caused environmental harm by foregoing options to cut insecticide use and adopt no-till practices. Europe’s regulatory example also discouraged the adoption of GMO food crops around the world. Europe is now inviting similar harms by classifying and regulating gene-edited crops as GMOs, but this most recent aversion to agricultural science is less likely to enjoy global influence.
The EU F2F policy may ultimately be derailed by the war in Ukraine which has made many of its goals impractical in the face of soaring prices for barley, corn, sunflower seeds and oil, wheat and fertilizers, which both Ukraine and Russia are major producers of. The EU obtains half of its corn from Ukraine, and a third of its fertilizers from Russia.
An article in the Financial Times in March noted,
The EU is reviewing the bloc’s sustainable food strategy…Brussels agreed two years ago to reform its farm practices as part of a drive to eliminate net carbon emissions by 2050. But Russia’s invasion of Ukraine has seen a drop in grain and fertilizer exports from those countries and raised concerns over food security. The bloc’s agriculture ministers meet…to discuss both short-term measures to alleviate the risk of shortages and price rises and possible changes to its Farm to Fork sustainable food strategy. There is a desire to make sure that the objectives we have in our public policy are consistent with the need for food security . . . and sovereignty, said an EU diplomat. French president Emmanuel Macron said the sustainable food strategy was based on a pre-Ukraine war world and should be reviewed… Copa-Cogeca, the EU farmers’ lobby group, has sent a list of demands to Janusz Wojciechowski, the European agriculture commissioner. A paradigm shift is needed . . . starting with the objectives, targets and timeline of the Farm to Fork strategy…It wants to increase fertilizer imports, pesticide use and cultivation of crops for animal feed while calling for opt-outs from ecological schemes and climate-linked animal welfare standards. Pekka Pesonen, secretary-general of Copa-Cogeca, said the best way to reduce carbon emissions was to increase productivity. He wants new technologies permitted that would allow gene editing to improve the output of animals and plants.
In the long-term, the EU position against genetic engineering is unsustainable because it will place European farmers at a severe disadvantage to farmers in other countries who will have the tools to create drought, disease, browning, disease and insect resistance and more nutritious and tastier crops. These crops will be far superior to the ones grown in the EU. Disease resistant GE crops for example will result in a huge cost savings in terms of waste and spoilage and substantially less fungicide use.
Paradoxically in this regard, Dutch and Irish scientists have created a cisgenesis potato resistant to late blight disease. It is unlikely though EU farmers will ever be able to cultivate the potato if the prevailing regulatory environment that strangles research and development of GE crop persists. They will also not be able to take advantage of research that is likely to lead to wheat resistant to wheat rust, tomatoes resistant to powdery mildew, apples resistant to fire blight and grapes resistant to powdery mildew.
An article in “Trends in Plant Science”, outlined the benefits that adopting GMO crops could bring to Europe. It said,
Genetically modified (GM) crops can help reduce agricultural greenhouse gas (GHG) emissions. In addition to possible decreases in production emissions, GM yield gains also mitigate land-use change and related emissions. Wider adoption of already-existing GM crops in Europe could result in a reduction equivalent to 7.5% of the total agricultural GHG emissions of Europe. The public debate about GM crops and new genomic breeding technologies remains contentious, especially in Europe. Critics focus primarily on hypothetical risks, while ignoring actual and potential benefits. Various reviews of the scientific literature show that the adoption of GM crops leads to economic, environmental, and health benefits through higher crop yields, higher farm profits, and, in some cases, lower chemical pesticide use. A few studies also show that certain GM crop applications help reduce GHG emissions and support carbon sequestration in the soil by facilitating reduced tillage farming…As global demand for food production continues to grow, crop yield increases can reduce the need to add new land into production, thus preventing additional CO2 emissions from land-use change.
Garlich von Essen, the Secretary-General of the European Seed Association, has warned that if the EU does not alter its stance on genetic engineering of crops, EU based crop breeding companies will be compelled to relocate their advanced breeding programs to more friendlier countries in order to “remain at the cutting edge of technology, attract the best breeders and develop the advanced plant varieties we all want to see.” He also said farmers in the EU expect
the EU Commission to give them access to the same innovative tools as their competitors in other parts of the world…The pressure on the EU will be growing as more and more countries around the world take a different approach and will probably see the EU’s approach as a protectionist one that blocks market access and trade.
By continuing to reject GE technology, the EU will make it more difficult for the EU to reach its farm sustainable goals and reduce agricultural greenhouse gas emissions as genetic engineering is an important tool in reaching those goals because disease resistant crops use much less fungicides, insect resistant crops use much less insecticides, crops that create their own nitrogen require much less fertilizers, drought resistant crops can survive warmer temperatures and browning resistant crops will cause much less waste. Genetic engineering will provide the tools to achieve many of the objectives the EU desires in agriculture but foregoing biotechnology will make it much more difficult to attain these goals.
The Brexit way
On September 29, 2021, the UK government, relaxed regulations regarding research and development of gene-edited crops thereby freeing scientists from the straightjacket of restrictions and red tape that had stifled such research when the country was a member of the EU. In announcing the move, Environment Secretary, George Eustice, said,
Our departure from the EU has given us the opportunity to adopt a more scientific and proportionate approach to the way that we do things like the regulation of organisms produced by genetic technologies such as gene editing.
The government indicated that for now, GMO regulations will continue to apply where DNA from one species is transferred to another but such regulations will be reviewed “more broadly” in the future. It also indicated that it will strive to pass legislation in 2022 that will regulate gene-edited crops on the same basis as crops developed via traditional breeding methods, thereby allowing their commercialization.
As part of the move to deregulate crop biotechnology, effective the end of 2021, researchers who want to conduct field trials of gene-edited crops will no longer have to submit a risk assessment. This will reduce the costs of the trials. They still though will need to register their plans with the Department for Environment, Food and Rural Affairs.
The relaxation of rules on gene-edited crops only applies to England while Wales, Northern Ireland and Scotland will continue to maintain tight controls.
The scientific community warmly welcomed the change in regulations. Angela Karp, director and CEO of Rothamsted Research, which has conducted crop gene-editing research, applauded the move saying,
We very much welcome this important announcement that regulation of gene-edited crops for research and development will now be approached in an appropriate, evidence-based manner.
Chief Scientific Adviser, Professor Gideon Henderson, said:
Gene editing is a powerful tool that will help us make plant breeding more efficient and precise by mimicking natural processes that currently take many years to complete. With the new rules now formally in place, scientists will be able to assess new crops in real-world conditions more easily. This will increase our ability to harness the potential of gene-editing to efficiently help grow plants that are more nutritious, beneficial to the environment, more resilient to climate change, and resistant to disease and pests.
Professor Nick Talbot, the executive director of the Sainsbury Laboratory, in Norwich, said,
We can achieve the outcomes of plant breeding – which has been so successful in controlling diseases and improving yields – but in a much more precise manner… to produce nutritious crops requiring much lower fertilizer inputs and with greater resilience. We need innovation to help us escape from the chemical treadmill of current agriculture. In the face of the climate emergency, doing nothing is no longer an option.
As expected, opponents of crop genetic engineering and the organic industry denounced the government action. Liz O’Neill, director of GM Freeze, said,
Genetic engineering – whatever you choose to call it – needs to be properly regulated. The government wants to swap the safety net of proper public protections for a hi-tech free-for-all – but our food, our farms and the natural environment deserve better.
Joanna Lewis, the Director of Policy and Strategy at the Soil Association, said
gene editing was the wrong approach and the government should instead focus on helping farmers become more sustainable. What would help is a reversal of the … lack of investment in agro-ecological, nature-friendly methods and farmer-led technology.
Dr Helen Wallace, of Genewatch, described the changes as a
weakening of standards meant to protect human health and the environment…People won’t be fooled. GM crops are GM crops. Whether they are made with new or old techniques, they can lead to unintended consequences.
Although there has been no commercialization of gene-edited or GMO crops in the UK because of stifling EU regulations, UK scientists have conducted a great deal of research on genetically engineered plants which should expedite their commercialization when regulations and guidelines are further relaxed. Rothamsted Research, the Sainsbury Laboratory and the John Innes Centre have been in the forefront of that research.
Rothamsted Research is conducting field testing of gene-edited wheat that has a lower content of Asparagine, which can be converted to acrylamide, a toxin, when flour prepared from the grain is used to make food. Acrylamide is regarded as a probable cancer-causing agent. Reduced asparagine concentration in wheat grain could therefore lower the exposure of consumers to acrylamide, thus reducing the risk of cancer.
In conjunction with Yield 10 Bioscience of the US, Scientists at the Rothamsted Institute, have been able to genetically modify Camelina sativa, a relative of oil seed rape, to produce omega-3 which is normally sourced from fish oil. Field trials indicate the fish oil contains high levels of EPA and DHA, both of which are important ingredients of fish oils. They are highly beneficial to human health and are linked to improvements in blood lipid levels, reduced tendency for thrombosis, blood pressure and heart level improvements, improved vascular functions and helps with eye and joint health and infant development.
Scientists at the John Innes Centre have identified via gene-editing technology a gene in wheat that is responsible for 50% of the yield of the crop. This opens up the possibility of breeding high yield wheat varieties. In addition, gene-editing could introduce other variable traits to wheat such as resilience and disease resistance.
Gene-editing research on glucosinolate levels is being conducted on cruciferous vegetables such as broccoli, cabbage and kale at the John Innes Centre. Glucosinolates are believed to have health promoting effects, including anti-carcinogenic properties, promoting improved glucose control and reducing the risk of cardiovascular disease. Increasing the levels glucosinolates via gene-editing techniques could as a result lead to the cultivation of more healthy vegetables.
In 2020, scientists at the John Innes Center were able to confer resistance to a deadly fungal disease by transferring genes from wheat into barley. Dr. Asyrak Hatta, said,
We have shown that wheat stem rust resistance genes work in barley which is something that has not been achieved by wide crosses between grass relatives. Given that we know that wheat resistance genes work in barley it is likely that barley resistance will also work in wheat…This might therefore expand the reservoir of resistance genes available to wheat for engineering resistance to its major diseases.
The Sainsbury Laboratory is conducting field trial of a cisgenic potato that is resistant to blight. The potato was developed by inserting a gene from a wild potato into the Maris Piers potato variety.
Researchers at the University of York have partnered with the Universidad Austral de Chile to genetically modify wheat plants by increasing the amount of a protein that control the growth rate thus producing grains that are up to 12% larger than conventional varieties.
Tropic Biosciences is a Norwich based company that develops “high-performing commercial varieties of tropical crops which promote cultivation efficiencies, enhance consumer health, and improve sustainable environmental practices, using cutting edge genetic-editing technologies.”
On November 4, 2021, the company received confirmation from the USDA that its gene-edited potato with reduced browning characteristics were determined to be exempt from regulations. This was the first regulatory approval of a crop developed by the company using its proprietary Gene-Editing Induced Gene Silencing technology. This technology is being utilized to develop valuable traits in coffee and rice and is being used to develop bananas that are resistant to Panama Disease.
While the measures taken by the British government to deregulate gene-editing are encouraging, full deregulation that will allow the commercialization of gene-edited crops faces several hurdles. First, there will be ferocious opposition from the anti-GE lobby and the organic food industry. Despite the scientific evidence indicating genetically engineered foods are safe for humans and animals and the environment, the forces against genetic engineering have learned the lesson that it is easier to scare people than to reassure them.
In response to the government’s announcement of changes in the law for field trials for gene-edited crops, Pat Thomas, Director of Beyond GM said,
There’s a lot of techno optimism about what kind of gene-edited foods might materialize one day, eventually, in the fullness of time…The reality is that after 35 years of use genetically engineered crops have not delivered much in terms of real value and they have largely been a distraction from more meaningful discussions about what kind of food system we want and need to transition to…There are no clear scientific criteria for deregulation and no plan to develop social, ethical or values-based criteria that will enrich and guide the approval process for genetically engineered plants.
Second, the issue of labelling gene-edited crops is likely to prove to be contentious. At present all foods that contain GMOs must be clearly labeled. Beyond GM and Slow Food have been lobbying supermarkets to refuse to sell unlabeled gene-edited food.
Third, although England is taking the lead on deregulating gene-edited crops, it does not necessarily mean that Scotland, Wales and Northern Ireland will follow. With regard to Scotland, the ruling Scottish National Party has its eyes on another independence referendum and if it is successful its objective would be to join the EU. As a result, even though many in the scientific community are urging the Scottish government to follow England and deregulate gene-editing, this is unlikely to happen because if Scotland gains its independence it will have to follow EU regulations if it wants to become a member.
It may well ultimately be the case that each of the four nations comprising the UK will have a different regulatory regime. This will impose additional costs for food producers in terms of sale, transportation and tracing of food within the UK.
Fourth, there are fears in the farming community that by adopting gene-editing technology they could lose access to the EU market because of its antipathy to the technology.
Finally, politics could always get in the way of changing the regulations if a government or Prime Minister comes into office that is less favorably disposed toward gene-editing.
Elsewhere in the world
In 2019, the Australian government, which has sanctioned the cultivation of GMO cotton, canola and safflower, indicated it will not regulate gene-edited plants as long as they do not contain DNA from other species. Previously research was restricted because gene-editing came under the same rules as GMOs which require approval from a biosafety committee accredited by the Office of the Gene Technology Regulator. According to the government however, the deregulation measure only applies to genetic engineering technologies “in which proteins cut DNA at a specific target site — as long as the tools allow the host cell to repair the break naturally, rather than using a template containing genetic material to direct the repair process.” As a result, it does not apply to all gene-editing tools. The deregulation though will apply to CRISPR.
Switzerland does not cultivate any GMO crops. It usually follows EU regulations given that the EU is its dominant trading partner. However, it has recently altered its policy towards gene-edited crops, adopting a more scientific approach.
In March, the government indicated that the moratorium on GMO cultivation will remain until 2025 but regulations will be relaxed for genomic editing and targeted mutagenesis in plant breeding “provided that precision breeding offers advantages over conventional breeding.”
The Parliament has requested the Federal Council to draft a bill by mid-2024 that would regulate how “a risk-based authorization of precision breeding could look.” The risk-based authorization is to apply
to plants, plant parts, seeds and other plant propagating material for agricultural, horticultural or forestry purposes, which have been bred using methods of new breeding technologies, to which no transgenic genetic material has been inserted and which have a proven added value for agriculture, the environment or consumers compared to conventional breeding methods.
Japan does not produce any GMO crops but in 2019, the government indicated gene-edited foods could be produced and sold to consumers without a safety evaluation. According to Hirohito Sone, an endocrinologist at Niigata University, who chaired the expert panel that advised the government, “There is little difference between traditional breeding methods and gene editing in terms of safety.” Although the government has essentially deregulated gene-edited crops, the government must be notified of any gene-edited crops that are being developed and informed about the specific gene-editing technique and the genes that were targeted for modification.
A gene-edited tomato has been developed in Japan and went on sale in 2021. It was modified to five times the amount of gamma amino batric acid than conventionally grown tomatoes. High levels of gamma amino batric acid may help to reduce blood pressure.
Israel does not grow any GMO crops but it has warmly embraced gene-editing. According to the 2021 USDA Biotechnology Report for Israel, “In March 2017, the National Committee for Transgenic Plants published a decision stating that genome edited plants…with no insertion of foreign DNA, are not considered to be transgenic and will not be subjected to the GE Seed Regulation. The applicant must, however, submit data showing that they meet the determined criteria to ensure that foreign DNA sequences were not incorporated into a plant genome.”
Scientists in Africa are urging African governments to adopt gene-editing technology to help feed the continent’s growing population. Dr. Chiedozie Egesi, senior scientist at the International Institute of Tropical Agriculture in Nigeria, said,
We need technologies such as gene-editing to increase our productivity, enhance the nutrition status of our crops and make them more resilient to climate change and a pandemic environment… we have seen promising landmark research for virus resistance in banana and cassava, pest resistance against the fall armyworm in maize and better nutrition, less cyanide in cassava and high iron and zinc in cassava, among others.
Kenya and Nigeria have both moved to deregulate gene-edited crops. In March, Kenya published Genome Editing Guidelines specifying that genome edited and derived products will not be regulated under the Biosafety Act if the modifications are made by inserting genes from sexually compatible species, deletions/knockouts without foreign genetic material in the end product, and processed products whose inserted foreign material cannot be detected. Applicants for research on gene-edited crops however would be required to submit an “Early Consultation Form” to the National Biosafety Authority that provides data on their project experimental processes and end product to “establish whether it should be regulated under the Biosafety Act or not.”
In outlining regulations regarding gene-edited crops in February, Nigeria’s Director-General/Chief Executive Officer of The National Biosafety Management Agency, Dr. Rufus Ebegba, said,
there are some products, due to the process of development, that fall squarely within the purview of biosafety regulations, because those ones are referred to as genetically-modified products… However, those that do not fall within the purview of genetically-modified products may not require a rigorous biosafety process.
Those nations that do not relax their regulations regarding gene-editing of plant crops will not be able to avail themselves of the innovations in crop production that will spur the development of disease, drought, insect and browning resistant and more nutritious crops. They will also be putting their farmers and agriculture industry at a severe disadvantage by reducing their competitiveness in world agricultural markets.
Gene-editing is not a luxury but is a necessity to grow the food required for an increasing world population, help to deal with climate change and food waste and create crops that are more nutritious. Those countries and organizations who oppose this advance in biotechnology for purely ideological reasons that defy the laws of science are on the wrong side of history.
Steven E. Cerier is an international economist and a frequent contributor to the Genetic Literacy Project.
