How and why gene editing faces fewer global regulations than GMOs - Part 2

Date:08-26-2022

Read How and why gene editing faces fewer global regulations than GMOs - Part 1

By Steven Cerier

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-Ukraine war 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.

Credit: PotatoPro

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.