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

Date:08-25-2022

By Steven Cerier

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.

To be continued in How and why gene editing faces fewer global regulations than GMOs - Part 2