research questions on genetically modified organisms

20 GMO questions: Animal, vegetable, controversy?

Here's a bullet-point summation of what nathanael johnson learned about gmos in 2013..

This is a slightly unusual end-of-the-year list. Instead of a selection of the best or worst news over the year, this is simply a bullet-point summation of what I’ve learned about GMOs in 2013.

When I started this series , I proposed to cut through the debate by finding the facts that both sides agree upon. I also proposed to do this ( back in July ) “over the next few weeks.” Ha. Not only has this taken me much longer, I’ve also learned that this controversy has turned into something resembling trench warfare, where the two sides refuse to agree on anything, lest they give up an inch of their hard-won position. So I don’t expect everyone to agree with the list below, but I do expect that reasonable people on both sides will concede (if only under their breath) that the bulk of the evidence leads to these conclusions.

As I’ve dug into this over the past six months, I know I’ve provided more detail than all but the most fascinated readers really wanted. In this list, therefore, I’ve aimed for brevity. If you want more nuance I’ll include links to the longer stories, which, in turn, contain links to even more technical scholarly articles, not to mention a detailed dissection of my every sentence in the comments.

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I’ve heard that GMOs are totally unregulated, is that true?

Nope. In the United States, GM food is regulated by the USDA, the FDA, and the EPA. The FDA process is technically voluntary, but every creator of GM food has opted to jump through those hoops, so it’s voluntary in name only. Genetically engineered foods are regulated much more heavily than many other new technologies, including other modes of genetically modifying crops, like mutagenesis .

Caveats: The regulatory process is not transparent — you can’t just go on the web and look up the tests that have been performed. And non-food plants may escape regulation, as was the case in this instance .

More nuance here .

Do the big seed companies prevent scientists from doing research on their patented plants?

They used to. Not anymore. I’ve been asking university scientists if they’ve run into restrictions, but the system seems to be working.

Are there dangers for scientists working on genetically engineered plants?

Yes. Anyone who challenges an accepted paradigm — like the consensus that genetic engineering is basically safe — will come under attack (see Copernicus, Galileo, and Thomas Kuhn ). On the other hand, there are huge rewards for anyone who is able to overturn a paradigm.

There are dangers on the other side too: Scientists have had to abandon their work on genetic engineering because of popular resistance to the technology.

More nuance here , and here .

Is genetic engineering more likely than other forms of plant breeding to create unforeseen changes?

Slightly. Here’s the National Research Council’s assessment of how likely it is that a technique will lead to something unexpected. (Biolistic transfer and Agrobacterium transfer are what we normally think of as “genetic engineering.”)

National Research Council Relative likelihood of unintended genetic effects associated with various methods of plant genetic modification. Click to embiggen.

Is that difference relevant?

Hard to say, but so far it probably hasn’t been relevant. Note that there is one method more likely to cause unintended changes than genetic engineering: mutagenesis. Our worries about genetic engineering (paradoxically) have led to a surge in the use of mutagenesis , and even that hasn’t led to problems. Crop scientists back-cross both mutated and genetically engineered plants, breeding them with the parent variety for generations to eliminate any unwanted changes.

More nuance  here , and  here .

What about newer forms of genetic engineering?

We’re now seeing many new plants bred for disease resistance using gene-silencing techniques, which, as you can see, isn’t included on the chart above. Others will follow. Each will have to be evaluated on its own merits.

Isn’t genetic engineering more likely to create allergens?

If you are moving genes from a plant that contains a lot of known allergens, then absolutely, you’ve got to watch out. And we do a really good job testing for this. There’s a different danger in introducing some unknown allergen — and we don’t have great ways of testing for  that.

So, does the chance that novel allergens could emerge make genetic engineering dangerous?

Every immunologist I’ve talked to — including those suggested to me by activists concerned about GMO allergens — told me that the risk of novel allergens arising through genetic engineering is very low.

More nuance  here .

But what about those studies suggesting that GMOs are harmful?

A couple of those do exist. It’s important to look at them carefully, with an open mind. It’s also important to do the same with the hundreds of studies suggesting that GMOs aren’t harmful. When you consider the evidence in sum, the products out there look pretty darn safe.

Isn’t it possible that some subtle, unintended shift in corn DNA is causing the obesity epidemic, the rise of autoimmune disorders, autism, and  Morgellons disease ?

It is possible. But all the new technologies we’ve introduced, from cellphones to pesticides to SUVs, have the same association. There are a lot of other hypotheses to explain these things with actual evidence backing them up. When I spoke with scientists working on these problems, none of them thought that a connection to genetic engineering was likely. And Morgellons is caused by the tiny spider drones the CIA has been injecting under your skin.

Have genetically engineered crops reduced insecticide applications?

Yes, in a big way. This advantage may evaporate as insects develop resistance (some already have). But scientists have created variations on the insect resistant crops and entomologists say that genetic engineering will continue reducing insecticides if we use it well.

Haven’t the decreases in insecticides been dwarfed by increases in herbicides?

Yes. We know for sure that farmers are now using a lot more of the herbicide glyphosate. As a result, more glyphosate-resistant weeds developed. At the same time, farmers began reducing other herbicides. And if you zoom out to look at all the herbicide-resistant weeds (not just glyphosate-resistant ones), the overall rate at which they’ve developed hasn’t been changed by genetic engineering.

Caveat: Glyphosate is much less toxic to humans than most other herbicides, so you could argue that increasing glyphosate and decreasing other herbicides is good.

Caveat to the caveat: Glyphosate does its job so well that it completely eliminates weeds like milkweed from fields. That decline in biodiversity on farms threatens insects, like monarch butterflies .

What about soil and carbon? Have GMOs led to carbon capture and soil preservation by facilitating an increase in no-till and low-till farming?

In South America, yes. In the United States GM seeds have helped some farmers make the transition to conservation tillage, but that hasn’t amounted to a big change.

Who has profited from genetically engineered crops?

Seed companies like Monsanto have made a lot of money. Farmers have reaped some of the rewards. And eaters have benefited a little from slightly lower prices.

Aren’t there big problems caused by the fact that genetically engineered seeds are patented?

Sure. There have been all sorts of nasty lawsuits over patented seeds. Any time useful inventions are locked up, innovation slows down. It used to be that seeds were all open source, that is, farmers shared their innovations freely. But this isn’t a problem unique to genetic engineering: Conventionally bred plants can be patented, and genetic engineers can make their inventions open source .

More nuance here.

But that’s nothing, what about Monsanto forcing farmers to buy their seeds by spreading the terminator gene?

That’s just not happening. The so-called terminator gene never got off the ground. And this general technology (with the clunky name GURT) would actually be a good thing in my opinion, because it would prevent genetically engineered DNA from spreading too far .

Is genetically engineered pollen spreading into regular old plants?

Yep. And this can cause problems for organic farmers, who lose a big premium if they have too many genetically engineered seeds in their harvest. It can also cause problems when an organic farmer’s pollen spreads into a field of genetically engineered plants.

Do genetically engineered crops help or hurt poor farmers?

It’s hard to tell. In sum GMOs improve economics for farmers, but this could mean that the richest are getting much richer while the poorest get a little poorer. There are a few recent studies that have taken this into account and they suggest that even smallholders benefit from GM crops. Scientists are working on a few crops designed specifically to help the poor.

More nuance here , and here , and here .

Do we absolutely need genetically engineered crops to feed the world?

No. So far GMOs have mainly been used in animal feed and biofuels. Genetic engineering has helped minimize the amount of grain lost to insects and weeds, but it hasn’t boosted intrinsic yields .

So should we label GMOs?

This is opinion, not fact, but I think so. Look, it may not make much sense to fixate on this one particular technology, but like it or not, people are fixated. Labeling removes the fear of the unknown.

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Block party: Are activists thwarting GMO innovation?

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• v.12(3); 2020 Mar

Genetically Modified Products, Perspectives and Challenges

Dimitrios t karalis.

1 Nutrition and Dietetics, University of Thessaly, Volos, GRC

Tilemachos Karalis

2 Obstetrics and Gynecology, General Hospital of Trikala, Trikala, GRC

Stergios Karalis

3 Internal Medicine, General Hospital of Trikala, Trikala, GRC

Angeliki S Kleisiari

4 Nutrition and Dietetics, University of Thessaly, Trikala, GRC

It is a common ground that humans have always modified the genome of both plants and animals. This intrusive process that has existed for thousands of years, many times through mistakes and failures, was initially carried out through the crossing of organisms with desirable features. This was done with the aim of creating and producing new plants and animals that would benefit humans, that is , they would offer better quality food, more opportunities for people to move and transport products, greater returns to work, resistance to diseases, etc. However, creating genetically modified organisms does not proceed without conflicts. One part of the equation concerns objections made by disputants of genetically modified organisms to the manipulation of life, as opposed to defenders who argue that it is essentially an extension of traditional plant cultivation and animal breeding techniques. There are also conflicts regarding the risks to the environment and human health from using genetically modified organisms. Concerns about the risks to the environment and human health from genetically modified products have been the subject of much debate, which has led to the development of regulatory frameworks for the evaluation of genetically modified crops. However, the absence of a globally accepted framework has the effect of slowing down technological development with negative consequences for areas of the world that could benefit from new technologies. So, while genetically modified crops can provide maximum benefits in food safety and in adapting crops to existing climate change, the absence of reforms, as well as the lack of harmonization of the frameworks and regulations about the genetic modifications results in all those expected benefits of using genetically modified crops being suspended. However, it is obvious that the evolution of genetically modified products is not going to stop. For that reason, research on the impact of genetic modification on medical technologies, agricultural production, commodity prices, land use and on the environment in general, should therefore continue.

Introduction and background

Biotechnology has developed many procedures that specialize in genetic recombination; the attempt to move genes from one organism to another or to change the genes present in a specific organism results in the expression of new attributes that originally were not there. The above procedures that allow gene alterations of a food or an organism result in Genetically Modified (GM) food or Genetically Modified Organisms (GMO). The concept of gene altering has initiated many debates, with one side criticising the unknown effects and risks on both public health and the environment, and the other supporting the genetic modification's benefits on economy and hunger elimination. This article attempts a literature review on Genetically Modified Products, and specifically the possible risks that they pose, the benefits of their production and use, as well as some basics concepts that have been described and analyzed in current published writings.

Possible risks of using genetically modified products

Environmental Hazards

There is strong evidence that genetically modified plants appear to interact with their environment [ 1 ]. This means that genes introduced into genetically modified plants may be transferred to other plants or even to other organisms in the ecosystem [ 2 - 3 ]. Gene transfer between plants, especially among related plants, results in genetic contamination and is carried out by the transport of pollen [ 4 ]. Because natural wild plant varieties are likely to have a competitive disadvantage against genetically modified crops, they may not be able to survive, resulting in the reduction or disappearance of wild varieties [ 5 ]. Changing biodiversity worldwide will result in increased resistance of several species of weeds, others to dominate and others to decline or disappear, thus creating a complete and general deregulation in ecosystems [ 6 ]. It is a common belief in scientific circles that research needs to be continued to assess the risks and benefits of crops more accurately and adequately.

Risks to Human Health

There may be allergenic effects - especially in people who are predisposed to allergies - or other adverse effects on human health [ 7 ]. Experimental studies in animals have shown weight gain, changes in the pancreas and kidneys, toxic effects to the immune system, changes in blood biochemistry among other effects [ 8 , 9 ]. Moreover, the lack of large-scale long-term epidemiological studies that lead to safe conclusions about the allergenic effects of genetically modified plants makes researchers skeptical about the use of genetically modified products. This is because the introduction of a gene that expresses a non-allergenic protein does not mean that it will produce a product without allergenic action. Also, allergies from genetically modified products may be more intense and dangerous, as the allergenic potential of these foods is stronger than that of conventional plants [ 10 , 11 ].

Resistance to Antibiotics

We must note from the outset that the use of antibiotic-resistant genes has stopped in most mutated products. The main problem now lies in the widespread use of antibiotics in feed which, as a natural consequence, end up in the human body through the consumption of dairy products and meat, and thus create resistant germs in the human digestive system [ 12 ]. However, more research and studies are needed to determine the differences between transgenic plants from traditional plants and whether genetically modified plants pose additional risks to the consumer public [ 13 , 14 ].

Benefits of using genetically modified products

Hunger Elimination

One of the arguments put forward by advocates of genetically modified products is to eliminate world hunger, a perception that has encountered various reactions [ 15 - 16 ]. A series of extensive and long-term research has shown that the benefits of growing genetically modified crops in the fight against global food shortages and hunger have been significant. The steady increase in the global population has led researchers to focus on the benefits of developing genetically modified products, rather than the potential risks they pose each time [ 17 ].

Economic Benefits

A number of studies show the economic benefits of using genetically modified products. Between 1996 and 2011, farmers' income worldwide increased by $92 million from the use of genetically modified crops. Part of the revenue is due to the more efficient treatment of weeds and insects, while another part is due to lower overall production costs. The greatest economic benefits have been achieved in the US, Argentina, China and India, while at the same time, production costs have fallen sharply [ 18 ]. At this point, however, there are conflicting reports [ 19 ].

Insect Resistance

Bacillus thuringiensis (or BT) is a Gram-positive, soil-dwelling bacterium, commonly used as a biological pesticide. During sporulation, many BT strains produce crystal proteins (proteinaceous inclusions), called δ-endotoxins, that have insecticidal action. This has led to their use as insecticides, and more recently, to genetically modified crops using BT genes, such as BT corn. The main target of these plants is to combat the European Corn Borer insect which is responsible for the destruction of maize crops with a loss of up to one billion dollars a year [ 20 ].

Nematode Resistance

Parasitic nematodes are responsible for much of the crop losses. They attack many different plants by destroying the root system. Nematodes, which are essentially a worm species, survive in the soil in very difficult conditions for many years. Chemical control of nematodes is prohibited because there is a high environmental risk. The only natural way to deal with this is through crop rotation (the practice of growing a series of dissimilar or different types of crops in the same area in sequenced seasons), but this is often not possible due to the high financial cost [ 21 ]. Thus, the introduction of genes from nematode-resistant plants seems to be the only way to deal with the problem [ 22 ]. 

Resistance to Herbicide Round Up

It is common ground that the use of herbicides and pesticides in general causes serious problems for the environment and, consequently, for human health. We know that in areas where wheat is cultivated, that is, where the use of herbicides is increased, the number of child births is clearly decreasing, complications in childbirth occur, and children are born with serious health problems mainly related to mental retardation and autism spectrum [ 23 ]. Genetically modified products enable farmers to use a smaller amount of herbicides. Genetically modified soy beans produce an enzyme resistant to the action of the herbicide. The herbicide Round Up destroys the action of a plant enzyme, thereby destroying the plant. Genetically modified plants, however, produce a glyphosate-insensitive form of this enzyme, making it resistant and not affected by the action of the herbicide [ 24 - 25 ]. Researchers are divided on the effects on human health and animals [ 26 ].

Cold Resistance

An important advantage of genetically modified plants is the creation of varieties that are resistant to cold temperatures that would normally result in the plant freezing and destroying the plant, thereby losing production. Since the mid-2010s, because of the rapid global change in climate and because plants cannot adapt to rapid temperature changes, scientists have turned to transgenic plants to address the problem [ 27 ].

Heat Resistance

In the near future, continuous global warming (as scientists at least claim) will have disastrous consequences for plants, especially in areas where water shortages are already occurring. Creation of modified genes (Sh2 and Bt2) can help plants withstand high temperatures [ 28 - 29 ].

Basic concepts related to genetically modified products

The Notion of Substantial Equivalence

The concept of substantive equivalence has been introduced in the debate on genetically modified products to ensure that these foods are safe [ 30 ]. The principle of substantive equivalence holds that if the genetically modified product contains substantially equivalent ingredients present in the conventional product, then no further safety rules are required. In this way the principle of substantial equivalence is a method of evaluating genetically modified products and finding negative factors (such as allergens due to the presence of new proteins) [ 31 , 32 ].

The Precautionary Principle

According to the precautionary principle, any new genetically modified product should not be made available to consumers unless there is first-hand evidence that the product is safe or if there are serious conflicts and conflicting opinions of researchers on the safety of the product in question [ 33 ]. Many researchers, however, have argued that the precautionary principle can act as a deterrent to the evolution of science and society, as it may stop or delay any new technology which is capable of solving environmental or economic problems [ 34 ]. We should note, however, that criticisms have been raised about the utility and the way the precautionary principle works [ 35 ].

The Safeguard Clause

The safeguard clause allows Member States of the European Union to prevent the circulation and sale of genetically modified products which may be harmful to citizens [ 36 ].

The Cartagena Protocol

The purpose of this document is to protect the world's biodiversity by instituting stringent rules on the transfer of genetically modified products from one country to another [ 37 ].

Labeling of Genetically Modified Products

The appearance of genetically modified products has resulted in the need for labeling of these products [ 38 ]. Genetically modified foods should have a special label indicating that they contain genetically modified ingredients. However, as simple as it sounds, the issue of genetically modified products labeling is particularly complex and difficult, as there are important questions about how labeling will be done [ 39 ]. For example, it has been argued that products containing either modified protein or foreign DNA should bear a special label. However, there are genetically modified products that do not contain modified protein or foreign DNA, so there is the debate whether these foods, although modified, require special labeling or not. [ 40 ].

Ethical Concerns

The key ethical issue regarding the cultivation of genetically modified plants is that the creation of these crops is essentially an interference with the natural flow of life. The ethical dilemma arises as to how to find the middle ground in the use of genetically modified products, given that different countries have different perceptions of the importance of risk, with many countries banning the use of genetically modified products, while companies producing these products focus on profits, and do not take into account the problems that may or may not arise. The problem here focuses on the high degree of uncertainty about the impact of using genetically modified organisms, while the arrangements proposed are usually shaped by financial and political interventions [ 41 ]. Consumer attitude is also of particular importance, as consumers are buying and paying their vote of approval at the same time. Consumers are divided into two categories, the consumers who favor the genetically modified organisms and those who oppose them. Consumers' views are influenced by the information they are offered each time, the existing regulations, the confidence they have in the government in regulating the issues that arise, and what they are prepared to pay [ 42 ].

Ethics and the Environment

Environmental ethics plays a dominant role in discussions concerning biotechnology and genetic engineering, as many of the arguments presented against genetic engineering have to do with whether it is morally right to genetically modify organisms and the environment, as this may have serious environmental impacts. This shift is evident even in product ads, where companies say environmental protection is a priority for them [ 43 ].

Ethics and Animal Rights

Specifically with regard to animals, modern ethical and philosophical considerations hold that animals, like humans, have rights and that these rights should in no way be violated [ 44 ]. Animals need to be treated as living organisms and not as commodities or human services. Introducing genes into animals and carrying out experiments can lead to drastic changes in the physiology and behavior of the animal. The results may not be desirable, and in some cases, they may even be disastrous [ 45 ].

Patenting Living (Genetically Modified) Organisms

The creation of new organisms inevitably leads to the need to register them and allocate their ownership. But even in the case of registration of a novel product, the 'owner' of the new organism must ensure that the genetic modification does not cause undesirable effects to the environment and humans, as he will be responsible for any problems that may arise [ 46 ].

Conclusions

In recent years there has been enormous technological progress in the creation of genetically modified organisms. There is no doubt that in the future there will be a continuum that will be influenced by both scientific developments and public attitudes towards genetically modified organisms. Creating genetically modified organisms, however, does not proceed without conflicts; there are the disputants of genetically modified organisms who see their production as a manipulation of life, as well as conflicts regarding the risks to the environment and human health. Even though, it is obvious that the evolution of genetically modified crops is not going to stop. Research on the impact of genetically modified crops on agricultural production, commodity prices, land use and the environment in general should therefore continue. Additionally, it is necessary to inform the consumer in order to understand the role of modern technology in crops and agricultural production, and in particular to understand the importance of genetic modifications. In any case, there should be strict and enforceable rules for the use of genetically modified organisms, an assessment of the potential risks of genetically modified crops and clear references to the effects and the results of genetic modifications, both on the environment and on human health.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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Food, genetically modified

These questions and answers have been prepared by WHO in response to questions and concerns from WHO Member State Governments with regard to the nature and safety of genetically modified food.

Genetically modified organisms (GMOs) can be defined as organisms (i.e. plants, animals or microorganisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination. The technology is often called “modern biotechnology” or “gene technology”, sometimes also “recombinant DNA technology” or “genetic engineering”. It allows selected individual genes to be transferred from one organism into another, also between nonrelated species. Foods produced from or using GM organisms are often referred to as GM foods.

GM foods are developed – and marketed – because there is some perceived advantage either to the producer or consumer of these foods. This is meant to translate into a product with a lower price, greater benefit (in terms of durability or nutritional value) or both. Initially GM seed developers wanted their products to be accepted by producers and have concentrated on innovations that bring direct benefit to farmers (and the food industry generally).

One of the objectives for developing plants based on GM organisms is to improve crop protection. The GM crops currently on the market are mainly aimed at an increased level of crop protection through the introduction of resistance against plant diseases caused by insects or viruses or through increased tolerance towards herbicides.

Resistance against insects is achieved by incorporating into the food plant the gene for toxin production from the bacterium Bacillus thuringiensis (Bt). This toxin is currently used as a conventional insecticide in agriculture and is safe for human consumption. GM crops that inherently produce this toxin have been shown to require lower quantities of insecticides in specific situations, e.g. where pest pressure is high. Virus resistance is achieved through the introduction of a gene from certain viruses which cause disease in plants. Virus resistance makes plants less susceptible to diseases caused by such viruses, resulting in higher crop yields.

Herbicide tolerance is achieved through the introduction of a gene from a bacterium conveying resistance to some herbicides. In situations where weed pressure is high, the use of such crops has resulted in a reduction in the quantity of the herbicides used.

Generally consumers consider that conventional foods (that have an established record of safe consumption over the history) are safe. Whenever novel varieties of organisms for food use are developed using the traditional breeding methods that had existed before the introduction of gene technology, some of the characteristics of organisms may be altered, either in a positive or a negative way. National food authorities may be called upon to examine the safety of such conventional foods obtained from novel varieties of organisms, but this is not always the case.

In contrast, most national authorities consider that specific assessments are necessary for GM foods. Specific systems have been set up for the rigorous evaluation of GM organisms and GM foods relative to both human health and the environment. Similar evaluations are generally not performed for conventional foods. Hence there currently exists a significant difference in the evaluation process prior to marketing for these two groups of food.

The WHO Department of Food Safety and Zoonoses aims at assisting national authorities in the identification of foods that should be subject to risk assessment and to recommend appropriate approaches to safety assessment. Should national authorities decide to conduct safety assessment of GM organisms, WHO recommends the use of Codex Alimentarius guidelines (See the answer to Question 11 below).

The safety assessment of GM foods generally focuses on: (a) direct health effects (toxicity), (b) potential to provoke allergic reaction (allergenicity); (c) specific components thought to have nutritional or toxic properties; (d) the stability of the inserted gene; (e) nutritional effects associated with genetic modification; and (f) any unintended effects which could result from the gene insertion.

While theoretical discussions have covered a broad range of aspects, the three main issues debated are the potentials to provoke allergic reaction (allergenicity), gene transfer and outcrossing.

Allergenicity

As a matter of principle, the transfer of genes from commonly allergenic organisms to non-allergic organisms is discouraged unless it can be demonstrated that the protein product of the transferred gene is not allergenic. While foods developed using traditional breeding methods are not generally tested for allergenicity, protocols for the testing of GM foods have been evaluated by the Food and Agriculture Organization of the United Nations (FAO) and WHO. No allergic effects have been found relative to GM foods currently on the market.

Gene transfer

Gene transfer from GM foods to cells of the body or to bacteria in the gastrointestinal tract would cause concern if the transferred genetic material adversely affects human health. This would be particularly relevant if antibiotic resistance genes, used as markers when creating GMOs, were to be transferred. Although the probability of transfer is low, the use of gene transfer technology that does not involve antibiotic resistance genes is encouraged.

Outcrossing

The migration of genes from GM plants into conventional crops or related species in the wild (referred to as “outcrossing”), as well as the mixing of crops derived from conventional seeds with GM crops, may have an indirect effect on food safety and food security. Cases have been reported where GM crops approved for animal feed or industrial use were detected at low levels in the products intended for human consumption. Several countries have adopted strategies to reduce mixing, including a clear separation of the fields within which GM crops and conventional crops are grown.

Environmental risk assessments cover both the GMO concerned and the potential receiving environment. The assessment process includes evaluation of the characteristics of the GMO and its effect and stability in the environment, combined with ecological characteristics of the environment in which the introduction will take place. The assessment also includes unintended effects which could result from the insertion of the new gene.

Issues of concern include: the capability of the GMO to escape and potentially introduce the engineered genes into wild populations; the persistence of the gene after the GMO has been harvested; the susceptibility of non-target organisms (e.g. insects which are not pests) to the gene product; the stability of the gene; the reduction in the spectrum of other plants including loss of biodiversity; and increased use of chemicals in agriculture. The environmental safety aspects of GM crops vary considerably according to local conditions.

Different GM organisms include different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a case-by-case basis and that it is not possible to make general statements on the safety of all GM foods.

GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved. Continuous application of safety assessments based on the Codex Alimentarius principles and, where appropriate, adequate post market monitoring, should form the basis for ensuring the safety of GM foods.

The way governments have regulated GM foods varies. In some countries GM foods are not yet regulated. Countries which have legislation in place focus primarily on assessment of risks for consumer health. Countries which have regulatory provisions for GM foods usually also regulate GMOs in general, taking into account health and environmental risks, as well as control- and trade-related issues (such as potential testing and labelling regimes). In view of the dynamics of the debate on GM foods, legislation is likely to continue to evolve.

GM crops available on the international market today have been designed using one of three basic traits: resistance to insect damage; resistance to viral infections; and tolerance towards certain herbicides. GM crops with higher nutrient content (e.g. soybeans increased oleic acid) have been also studied recently.

The Codex Alimentarius Commission (Codex) is the joint FAO/WHO intergovernmental body responsible for developing the standards, codes of practice, guidelines and recommendations that constitute the Codex Alimentarius, meaning the international food code. Codex developed principles for the human health risk analysis of GM foods in 2003.

Principles for the risk analysis of foods derived from modern biotechnology

The premise of these principles sets out a premarket assessment, performed on a caseby- case basis and including an evaluation of both direct effects (from the inserted gene) and unintended effects (that may arise as a consequence of insertion of the new gene) Codex also developed three Guidelines:

Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants

Guideline for the conduct of food safety assessment of foods produced using recombinant-DNA microorganisms

Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA animals

Codex principles do not have a binding effect on national legislation, but are referred to specifically in the Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organization (SPS Agreement), and WTO Members are encouraged to harmonize national standards with Codex standards. If trading partners have the same or similar mechanisms for the safety assessment of GM foods, the possibility that one product is approved in one country but rejected in another becomes smaller.

The Cartagena Protocol on Biosafety, an environmental treaty legally binding for its Parties which took effect in 2003, regulates transboundary movements of Living Modified Organisms (LMOs). GM foods are within the scope of the Protocol only if they contain LMOs that are capable of transferring or replicating genetic material. The cornerstone of the Protocol is a requirement that exporters seek consent from importers before the first shipment of LMOs intended for release into the environment.

The GM products that are currently on the international market have all passed safety assessments conducted by national authorities. These different assessments in general follow the same basic principles, including an assessment of environmental and human health risk. The food safety assessment is usually based on Codex documents.

Since the first introduction on the market in the mid-1990s of a major GM food (herbicide-resistant soybeans), there has been concern about such food among politicians, activists and consumers, especially in Europe. Several factors are involved. In the late 1980s – early 1990s, the results of decades of molecular research reached the public domain. Until that time, consumers were generally not very aware of the potential of this research. In the case of food, consumers started to wonder about safety because they perceive that modern biotechnology is leading to the creation of new species.

Consumers frequently ask, “what is in it for me?”. Where medicines are concerned, many consumers more readily accept biotechnology as beneficial for their health (e.g. vaccines, medicines with improved treatment potential or increased safety). In the case of the first GM foods introduced onto the European market, the products were of no apparent direct benefit to consumers (not significantly cheaper, no increased shelflife, no better taste). The potential for GM seeds to result in bigger yields per cultivated area should lead to lower prices. However, public attention has focused on the risk side of the risk-benefit equation, often without distinguishing between potential environmental impacts and public health effects of GMOs.

Consumer confidence in the safety of food supplies in Europe has decreased significantly as a result of a number of food scares that took place in the second half of the 1990s that are unrelated to GM foods. This has also had an impact on discussions about the acceptability of GM foods. Consumers have questioned the validity of risk assessments, both with regard to consumer health and environmental risks, focusing in particular on long-term effects. Other topics debated by consumer organizations have included allergenicity and antimicrobial resistance. Consumer concerns have triggered a discussion on the desirability of labelling GM foods, allowing for an informed choice of consumers.

The release of GMOs into the environment and the marketing of GM foods have resulted in a public debate in many parts of the world. This debate is likely to continue, probably in the broader context of other uses of biotechnology (e.g. in human medicine) and their consequences for human societies. Even though the issues under debate are usually very similar (costs and benefits, safety issues), the outcome of the debate differs from country to country. On issues such as labelling and traceability of GM foods as a way to address consumer preferences, there is no worldwide consensus to date. Despite the lack of consensus on these topics, the Codex Alimentarius Commission has made significant progress and developed Codex texts relevant to labelling of foods derived from modern biotechnology in 2011 to ensure consistency on any approach on labelling implemented by Codex members with already adopted Codex provisions.

Depending on the region of the world, people often have different attitudes to food. In addition to nutritional value, food often has societal and historical connotations, and in some instances may have religious importance. Technological modification of food and food production may evoke a negative response among consumers, especially in the absence of sound risk communication on risk assessment efforts and cost/benefit evaluations.

Yes, intellectual property rights are likely to be an element in the debate on GM foods, with an impact on the rights of farmers. In the FAO/WHO expert consultation in 2003 , WHO and FAO have considered potential problems of the technological divide and the unbalanced distribution of benefits and risks between developed and developing countries and the problem often becomes even more acute through the existence of intellectual property rights and patenting that places an advantage on the strongholds of scientific and technological expertise. Such considerations are likely to also affect the debate on GM foods.

Certain groups are concerned about what they consider to be an undesirable level of control of seed markets by a few chemical companies. Sustainable agriculture and biodiversity benefit most from the use of a rich variety of crops, both in terms of good crop protection practices as well as from the perspective of society at large and the values attached to food. These groups fear that as a result of the interest of the chemical industry in seed markets, the range of varieties used by farmers may be reduced mainly to GM crops. This would impact on the food basket of a society as well as in the long run on crop protection (for example, with the development of resistance against insect pests and tolerance of certain herbicides). The exclusive use of herbicide-tolerant GM crops would also make the farmer dependent on these chemicals. These groups fear a dominant position of the chemical industry in agricultural development, a trend which they do not consider to be sustainable.

Future GM organisms are likely to include plants with improved resistance against plant disease or drought, crops with increased nutrient levels, fish species with enhanced growth characteristics. For non-food use, they may include plants or animals producing pharmaceutically important proteins such as new vaccines.

WHO has been taking an active role in relation to GM foods, primarily for two reasons:

on the grounds that public health could benefit from the potential of biotechnology, for example, from an increase in the nutrient content of foods, decreased allergenicity and more efficient and/or sustainable food production; and

based on the need to examine the potential negative effects on human health of the consumption of food produced through genetic modification in order to protect public health. Modern technologies should be thoroughly evaluated if they are to constitute a true improvement in the way food is produced.

WHO, together with FAO, has convened several expert consultations on the evaluation of GM foods and provided technical advice for the Codex Alimentarius Commission which was fed into the Codex Guidelines on safety assessment of GM foods. WHO will keep paying due attention to the safety of GM foods from the view of public health protection, in close collaboration with FAO and other international bodies.

Food, Genetically modified

• Open access
• Published: 20 October 2022

Genetically modified organisms: adapting regulatory frameworks for evolving genome editing technologies

• Pablo Rozas 1 ,
• Eduardo I. Kessi-Pérez 2 , 3 &
• Claudio Martínez   ORCID: orcid.org/0000-0001-8564-9287 2 , 3  

Biological Research volume  55 , Article number:  31 ( 2022 ) Cite this article

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Genetic modification of living organisms has been a prosperous activity for research and development of agricultural, industrial and biomedical applications. Three decades have passed since the first genetically modified products, obtained by transgenesis, become available to the market. The regulatory frameworks across the world have not been able to keep up to date with new technologies, monitoring and safety concerns. New genome editing techniques are opening new avenues to genetic modification development and uses, putting pressure on these frameworks. Here we discuss the implications of definitions of living/genetically modified organisms, the evolving genome editing tools to obtain them and how the regulatory frameworks around the world have taken these technologies into account, with a focus on agricultural crops. Finally, we expand this review beyond commercial crops to address living modified organism uses in food industry, biomedical applications and climate change-oriented solutions.

Genetic modification of living organisms for food, feed, industrial, medical, and environmental uses has been an intense field of research and economic interest since the development of modern agriculture. From the development of DNA recombination in the 70’s, the rapid and transversal implementation of genetic engineering impacted several industries such as medicine, food, feed and scientific research itself. Nevertheless, the idea of modification of living organisms is older than DNA recombination technology.

Throughout history, humanity has tried to improve yields, resources optimization, nutritional content, and organoleptic characteristics of plant crops through various plant improvement techniques. i.e. , plant breeding. These techniques include artificial selection, selective crosses, mutagenesis induced by chemical or physical agents, and genetic engineering, among others [ 1 , 2 ]. In this context, genetic engineering has contributed to accelerate the developing times of new plant varieties and increasing their diversity, capacities and applications.

One of the most widely used genetic engineering technique, and a pioneer in the field of agricultural biotechnology, is transgenesis, which consists of the transfer of genetic material from one organism to another of a different species. This process makes it possible to achieve certain traits of technological, productive, nutritional, or research interest. The most frequently developed commercial traits are resistance to pathogens, tolerance to abiotic stress, and resistance to herbicides [ 3 , 4 , 5 , 6 ].

Although the potential of transgenesis in the agricultural development, the definition of a genetically modified organism (GMO) has been a controversial topic for consumers and an evolving concept in the literature and regulatory frameworks since the first applications of transgenesis became commercially available in the 1990s. Despite being associated with this technique, current international efforts have led to a broader definition of “living modified organism” (LMO) written down into The Cartagena Protocol on Biosafety to the Convention on Biological Diversity [ 7 ]. This defines a LMO as “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology”; where “living organism” is defined as “any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids”. On the other hand, “modern biotechnology” is defined as “the application of:

in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or

fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.”

This definition of LMO, hereinafter "GMO” for the scope of this review given its use in the historical literature, has a profound impact on regulatory strategies worldwide. In this review, we focus on the current technologies employed to develop GMOs, especially crops, and how regulatory frameworks are evolving to take new technologies into account. Moreover, we will discuss how the potential of genetically modified (GM) crops and other organisms can be exploited in other industries and in biomedical applications, as well as current efforts developed to address the challenge of climate change.

GMOs global landscape

Transgenesis has been rapidly implemented in world agriculture in terms of cultivated area. According to the latest reports from the International Service for the Acquisition of Agri-biotech Applications (ISAAA), issued in 2018 and 2019, GM crops have accumulated a total cultivated area of 2.53 billion hectares in 23 years of implementation of this technology (Fig.  1 ) [ 6 , 8 ]. In 2019, the last reported year, an area of 190.4 million hectares was cultivated with GMOs in a total of 29 countries, with the Americas being the continent with the largest cultivated area in the world (Table 1 ).

Cultivated area with GM crops worldwide. Plotted from data published in the ISAAA briefs of Global Status of Commercialized Biotech/GM Crops in 2018 and 2019 [ 6 , 8 ]

The most widely cultivated GM crops are soybean, maize, cotton, and canola, with an area of 188.6 million hectares, which corresponds to 99% of the area cultivated with GMOs worldwide (Fig.  2 ). About 90% of the area cultivated with GMOs is found in 5 countries (United States, Brazil, Argentina, Canada, and India) (Table 1 ). Most of the commercially available GM crops have been developed using transgenesis based on recombinant DNA technology, mainly to confer traits such as insect resistance, herbicide tolerance, and tolerance to abiotic stress (> 99% of total commercial traits)[ 8 ] (Table 2 ) or other non-frequent traits related to improved food fortification such as provitamin A biosynthesis in “golden rice” and “golden banana”, or increased starch content in EH92-527–1 potato [ 9 , 10 , 11 , 12 , 13 ]. These transgenic crops have been mainly used for food, livestock and poultry feed, and as ingredients for processed food such as protein extracts, oils and sugar; or for other industries such as ethanol (biofuel) or natural fibre production [ 14 , 15 ].

Adapted from the ISAAA brief of Global Status of Commercialized Biotech/GM Crops in 2019.

Cultivated area with GM crops reported for 2019. Adoption rate is shown as the percentage of cultivated area with GM crop compared to the total cultivated area for that crop, being GMO or not. [ 8 ]. *Other crops: Sugar beet, potato, apple, squash, papaya and eggplant.

The era beyond transgenesis: genome editing tools

New breeding techniques

Along with the process of transgenesis, in the last decade new technologies have been developed that allow editing the genome, or modify its expression, of the target organism in a precise, fast, and relatively cheaper way than other techniques, minted under the acronym "NBT" (" new breeding techniques ") (Fig.  3 ). The genome editing process is based on the use of nucleases able to generate double-strand breaks (DSBs) in specific sequences when guided by proteins or RNA [ 16 ]. These breaks are then repaired by the cellular endogenous DNA repair machinery via non-homologous end joining (NHEJ), allowing targeted modifications, such as insertions or deletions, potentially knocking out targeted genes. Moreover, DSBs can also be repaired by homology-directed repair (HDR) using endogenous or delivered template DNA sequence, leading to gene replacement or insertion of sequences of different sizes, from one to many hundreds of nucleotides [ 17 ].

New breeding techniques used for GM crops development. Zinc finger nucleases (ZFN), transcription activator-like effector nucleases (TALEN) and the bacterial system of clustered regularly interspaced short palindromic repeats (CRISPR), employing Fok1 or Cas9 nucleases, are used to target DNA sequences to promote downstream modifications. ZFN, TALEN and Cas9 induce double-strand breaks that are corrected by NHEJ or HDR, modifying the target sequence with deletions or different size insertions. Modified Cas9, such as catalytically null (“dead” Cas9 or dCas9) is used coupled to transcriptional repressor or activators to regulate gene expression. Other forms of modified Cas9, such as coupled to reverse transcriptase (RT) or deaminases, are used to modify target sequence with specific template primers (prime editing) or switch specific bases (base editing).

The extension, location and downstream effects of these editions will determine the phenotype of the new variety, with novel traits that are, in principle, independent of exogenous gene constructs, thus differentiating them from transgenesis. Nonetheless, the delivery methods used to insert genome editor expression cassettes or ribonucleoprotein complexes represent an obstacle to obtain commercial varieties free of exogenous DNA. This is noteworthy not only for regulatory concerns but also for the acceptance of the final products by consumers [ 18 , 19 ].

Currently, the three most widely used NBT are zinc finger domain-coupled nucleases (ZFN), transcription activator-like effector nucleases (TALEN) and the bacterial system of clustered regularly interspaced short palindromic repeats (CRISPR) coupled to the nucleases Cas9, Cas12, or Cpf1, among others [ 16 , 17 ]. ZFN and TALEN systems are based on nucleases, such as Fok1, coupled to tandem zinc finger protein domains or TALE protein repeats, respectively, recognizing specific DNA motifs by protein-DNA interaction. Once this protein-guided DNA interaction occurs, Fok1 nucleases dimerize and perform their enzymatic activity on the double-stranded DNA [ 16 ] (Fig.  3 ). For example, ZFN gene editing has been used on commercially relevant crops to modify endogenous genes involved in different phenotypes such as development in tomato [ 20 ], starch metabolism in rice [ 21 ], sexual fertility in apple and fig [ 22 ], RNA silencing genes in soybean [ 23 ] or confer resistance to imidazolinone herbicides in wheat [ 24 ]. Potentially commercial traits of interest have been developed using TALEN. For instance, to modify sugar metabolism and improve herbicide tolerance in potato [ 25 , 26 ], increase oleic acid content in peanut and soybean oil [ 27 , 28 ], or reduce lignin content and improve saccharification in sugarcane [ 29 , 30 ]. Early flowering is another trait of interest, allowing to face seasonal and logistic hurdles, and wild cabbage is an example of these research efforts performed by TALEN [ 31 ].

CRISPR systems

On the other hand, the CRISPR system is based on RNA-guided DNA pairing, taking advantage of the recently growing knowledge of bacterial CRISPR/Cas complex. This RNA–DNA interaction allows sequence specificity design in a more efficient, versatile, and cheaper way than ZFN and TALEN systems [ 16 , 17 , 18 , 32 ]. Furthermore, the use of tailored Cas complexes has expanded the toolkit for genome editing by incorporating base-switching enzymes, transcription regulators, or adding translational modifications [ 18 ]. To date, several variations have been made to the CRISPR/Cas system in order to obtain different modifications on the DNA sequences or regulate gene expression (Fig.  3 ). Nuclease-inactivated Cas9 (dCas9 for “catalytically dead Cas9”) allows Cas9 targeting DNA sequences guided by a guide RNA (gRNA) without producing strand breaks [ 33 ]. The coupling of dCas9 with transcriptional repressors or activators constitutes an adaptable tool to modify gene expression ( 34 ). Moreover, fusion of Cas9 with deaminases has been shown to be useful for C-T and A-G base replacement (known as base editors) [ 33 , 35 ].

In addition to precise base editing, the potential of modified CRISPR/Cas9 systems has been taken into a broader perspective with “prime-editing” tools. In this approach, a reverse transcriptase (RT) is fused to Cas9, and the gRNA is concatenated with template RNA for RT activity. This allows targeting the sequence of interest and editing multiple bases at once without template DNA [ 36 ]. In addition to targeting gene expression, CRISPR/Cas systems can also be used to modulate translation by editing upstream open reading frames (uORFs). These uORFs can regulate translation of the primary ORF, as demonstrated in lettuce modified in the LsGGp2 uORF, enhancing vitamin C biosynthesis [ 37 ].

CRISPR systems have been experimentally used on most commercial GM crops such as maize, soybean and cotton, along with several other crops, e.g. , apple, carrot, orange, raps, lettuce, grapes, pear, strawberry, cucumbers, wheat, rice, and tomato, in addition to ornamental flowers such as Dendrobium officinale (orchid), Ipomoea nil (morning glory), Petunia hybrid (petunia) and Torenia fournieri (wishbone flower) [ 16 , 18 , 32 , 38 , 39 , 40 ]. The traits obtained by CRISPR also cover a wide range of biotechnological interests such as sugar, fatty acid or pigment metabolism, herbicide tolerance, pathogen resistance, and development modifications, among others.

• Regulatory frameworks

Despite their differences, countries’ regulatory frameworks can be broadly classified as process-oriented or product-oriented [ 14 , 41 ]. The first determines criteria and regulations according to the methods used to generate new plant varieties, while the second applies criteria based on the new characteristics of a biotechnological event and makes comparisons with their conventional counterparts, both applying a case-by-case evaluation system. Noteworthy, these product- or process-oriented regulatory guides commonly share elements with each other, making legal frameworks difficult to categorize [ 41 , 42 ]. Parallel to the “regulatory style” of each country, the Cartagena Protocol, signed by more than 140 countries, constitutes an instance of international law with binding legal principles for the countries that have ratified it [ 7 ].

Most of the current regulations worldwide have been created to address transgenic-derived crops, which have the largest participation on markets. However, frameworks have been updated in several countries, mainly developed countries, to take genome-edited crops into account. Here we address the current status of regulatory frameworks for GM crops around the globe, in which, for the purpose of this review, we have categorized the main regulatory focus of each country as product- or process- oriented (although it is not a legal classification in any of these countries) (Table 3 ).

Latin America

In Latin America there are different types of regulation, from very permissive to moratorium. The lack of consensus is a characteristic of the region, where countries with similar regulations do not coordinate or share information on seeding requests. The “biotechnological mega-countries” (a term coined by ISAAA for countries growing more than 50.000 Ha of GM crops) in the region, being Argentina, Brazil, Bolivia, Colombia, Mexico, Paraguay and Uruguay, have regulations that allow the cultivation and/or trade of GMO, rendering them as important players in the global market. Other Latin America countries with planted GMOs such Costa Rica and Honduras, have similar regulations compared to the biotechnological mega-countries of the region. Chile has a unique regulatory framework where GMO crops can be planted for seed production and export, and research purposes but not for domestic food or feed uses [ 43 , 44 ]. Despite the regulation similarities within these countries, their definitions and lists of approved events are not synchronized, which delays the application of events throughout the region and weakens regional trade [ 14 ].

Therefore, at the XXXIV Extraordinary Meeting of the Southern Agricultural Council (CAS), held in 2017, the Ministers of Agriculture of Brazil, Chile, Paraguay and Uruguay, and the Secretary of Livestock, Agriculture and Fisheries of Argentina, declared it necessary to promote activities of regional cooperation and exchange of information for the approval of GMOs and to train "experts in new technologies" (related to NBT). The common characteristic in the regional regulations relies in evaluating food biosafety and field release (environmental and biodiversity) in a case-by-case and product-oriented manner, according to the institutions mandated for such purposes in each country [ 14 ].

On the prohibitive side of Latin American region, Ecuador, Peru, and Venezuela do not allow the commercial cultivation of GMOs. Ecuador, whose 2008 constitution defines the country as "free of transgenic crops and seeds", has made its position more flexible and allows the use of GM seeds for research purposes, through the Organic Law of Agrobiodiversity, Seeds and Promotion of the Sustainable Agriculture, decreed in 2017. In the case of Venezuela, the Venezuelan Seed Law, decreed in 2015, prohibits all GM crops in its territory.

In Peru, a transition towards a prohibitive policy has been observed. In 1999, through Law 27104, the regulation of GMOs was established, managing and controlling their confined use and release; in addition to regulating its introduction, commercialization, research, transportation, and storage, among others. It even decreed a law for the labelling of foods made with ingredients that contain GMOs (Law 29888). However, through the enactment of Law 29811, in 2011, a moratorium on the entry and production of GMOs in Peruvian territory was established for ten years, emphasizing the need to assess risks, protect biodiversity, and generate a new regulatory framework. This moratorium excludes GMOs cultivated for research purposes and in January 2021 the Peruvian Congress enacted an extension of the moratorium for fifteen more years from the end of the first ten-year period (Law 31111).

USA and Canada

The United States of America (USA) and Canada share a common regulatory style, considering the new GM plant varieties as conventional based on case-by-case biosafety analysis. This permissive style has allowed these countries to use their previous legislation to adapt it to the evaluation of GMOs [ 14 ]. Following this line, the USA, despite being the main producer of GM crops in the world, does not have federal legislation as a general framework to regulate GMOs. Depending on whether the purpose of the GM product is for human, animal and/or environmental use, its authorization and regulation fall under the standards of the Food and Drug Administration (FDA); the Animal and Plant Health Inspection Service (APHIS); or the Department of Agriculture (USDA) and/or the USA Environmental Protection Agency (EPA), respectively.

The case of Canada is unique in the world, considering a new term in its regulatory framework: “plant with novel traits” (PNT). In the Canadian regulatory framework, a new plant variety is considered a PNT if it meets certain differentiating criteria with its conventional counterpart, regardless of the methodology used to generate it, be it transgenesis, conventional breeding or NBT. Therefore, a new plant variety can be considered a PNT in Canada while being considered a GMO for the rest of the world. Despite the broad definition criteria, Canada has a biosafety evaluation system focused on toxicity, allergenicity, impact on field release and even impacts on organisms other than the PNT, through the Canadian Food Inspection Agency (CFIA) [ 11 ].

The regulations of the European Union (EU) have been classified as restrictive since they determine high biosafety standards for human and animal consumption, environmental impact and consumer interests, as stated in the first article of Regulation 1829/2003 EU. This standard gives much of the responsibility on the applicant to demonstrate the safety of the GM product and to monitor its cultivation or use as food. In addition, the EU regulation provides a framework for citizen participation by making public the Authority's opinions regarding new requests. Citizens can send their comments to the evaluation committee within a period of thirty days, through article 6 number 7 of the aforementioned Regulation. Such have been the levels of control in the EU in terms of applications to cultivate GMOs that in more than two decades only two biotechnological events have been approved for cultivation and in the last years only one is cultivated in Spain and Portugal (insect-resistant corn, MON810) [ 8 ].

Despite this, the EU is one of the main importers of GMOs for human consumption, being mainly soybeans and its derivatives (90–95% GMOs of total imports), maize (20–25% GMOs of total imports) and canola (25% GMOs of total imports) [ 8 ]. In addition to seeding restrictions, it has regulations on traceability and labelling of GMOs. The general standard of the EU regulatory style is based on the definition of process-oriented GMOs, defining a GMO in article 2 of Directive 2001/18/EC, as “if the method of genetic modification is carried out in such a way that does not occur by natural crossing and/or recombination”. This definition does not take into account the type of modification, be it gene insertion, regulatory sequences, specific nucleotide changes, etc. Therefore, it does not discriminate the type of methodology used to generate a GMO. On the other hand, this definition also includes conventional plant breeding, on which cases it has an allowing “historical” criterion.

The African continent has been slowly adopting GM crops with different regulations between countries, similar to Latin America. Africa is home to some of the countries with the largest area planted with GM crops in the world (South Africa, Sudan, Nigeria, Eswatini and Ethiopia) (Table 1 ), in addition to Malawi and Kenya. With regard to the cultivated plant varieties, South Africa has cultivated maize, soybeans and cotton, while other countries cultivate mainly IR/Bt cotton [ 8 ], for a total of 2.9 million hectares of GM crops in 2019.

South Africa was the first African country to regulate GM crops through the Genetically Modified Organisms Act No. 15 of 1997, while other countries began to regulate this technology since the early 2000’s (Kenya and Malawi) or the last decade (Egypt, Ethiopia, Eswatini, Ghana, Nigeria, Sudan, Burkina Faso and Uganda). Furthermore, Egypt, Ghana and Uganda do not allow GM crops cultivation for commercial purposes [ 14 ]. Burkina Faso has been producing Bt cotton since 2008 but stopped its production in 2016 due to quality concerns. Its regulation allows cultivation of GM crops, but there is currently no commercial production [ 45 ]. Although Egypt was a pioneering African country in developing and planting GM maize in 2008, GM cultivation was banned four years later due to a lack of biosafety laws [ 46 ].

Asia and Oceania

Asia is the main source of GM cotton, with India being the country with the largest cultivated area (11.9 million hectares of Bt cotton in 2019) [ 8 ]. Despite the approval of Bt cotton in India in 2002, several other food and non-food GM crops are not allowed and have been planted illegally since then, such as virus-resistant papaya, Bt brinjal/eggplant and IR/HT cotton [ 47 ]. Like India, Pakistan and China are also ones of the main producers of Bt cotton [ 8 ]. Beyond the domestic and export production of GM crops, China has led the research and development of GMOs obtained by NBT, being the main source of published articles and patent applications in this regard [ 48 , 49 ]. The Ministry of Agriculture and Rural Affairs is the institution responsible for new approvals and demands strict field and environmental assessments for new events, delaying the process from development to commercialization. This marks a difference with the USA and Canadian regulatory frameworks, that allow faster track for the application of new events [ 14 ].

Philippines is one of the key players in the market of GMOs in Southeast Asia, being a leading producer of GM maize in the region, and also an important commercial target for GM rice that harbours enzymes for the biosynthesis of the vitamin A precursor (golden rice), which is produced mainly in China [ 9 ]. Like Philippines, Indonesia also has a product-oriented regulation with the difference of a smaller production of GMO limited to sugarcane [ 8 ]. Similar to these cases, Vietnam and Bangladesh, in Asia mainland, also have a permissive regulatory style regarding GMOs but only one species is the main focus of production being maize and brinjal/eggplant, respectively [ 8 ].

In the Pacific region, New Zealand has a strict regulatory framework that takes Māori culture into consideration, prohibiting crops that may alter traditions, sites, flora, and fauna [ 50 ]. This has led to no GM crops being cultivated commercially in the country. Moreover, this regulatory framework also considers new plant varieties developed by NBT through the regulation of GMOs [ 41 ].

Japan and Australia allow the cultivation of GM crops but with different regulatory approaches. Japan leads in GM crops approvals behind the USA, but its strict confined field trials and environmental risk assessments have not allowed commercial production of GMOs for food or feed, but only for ornamental blue rose flower [ 51 ]. On the other hand, Australia has allowed commercial production of GM crops, being a major producer of cotton, canola, and safflower (ranked 13th in area cultivated with GMOs in 2019) (Table 1 ) [ 8 ]. Despite their different approaches to commercial cultivation of GMOs, Japan and Australia share common criteria for evaluating and defining new plant varieties developed by NBT, considering unguided repair of site-directed nuclease activity (SDN-1) organisms as non-GMO [ 52 , 53 ].

Beyond GM crops

Gm microorganisms.

Agriculture has been the activity with the most extensive research, development, and application of GMOs. However, several other fields have been taking advantage of this technology. Closely related to crops, the use of yeast has been a historical tool for the production of bread and alcoholic beverages (such as wine and beer). Furthermore, due to the extensive knowledge of yeast genetics and cell biology, the biotechnological application of yeasts, as well as other fungal species, has rapidly evolved and spans various industries, such as biofuel production, medical applications, and alcoholic beverages itself. For example, genetic modification of yeast strains has been experimentally tested to modulate ethanol yields [ 54 , 55 ].

Although the use of GM yeasts in industrial applications such as bioethanol and pharmaceutical production is not a problem (the commercialization of recombinant insulin is an example of this), the use of GM yeasts for food production has faced the same problems associated with GM plants, i.e. , legal restrictions and consumer rejection, which lead to the limited commercial success that recombinant yeasts have had in the food industry [ 56 , 57 ]. For example, in the wine industry, there are only two commercialized GM strains: one for better metabolization of urea [ 58 ] and other for simultaneous alcoholic and malolactic fermentation [ 59 ]. Most commercialized wine yeast strains have resulted from the selection of strains naturally present in different ecosystems [ 60 , 61 , 62 ], followed by hybridization [ 63 , 64 , 65 ], and, in recent years, from breeding programs (similar to those made in plants and animals) [ 57 , 66 , 67 ].

All the aforementioned aspects are relevant not only for the use of yeast but also other microorganisms for food production, e.g. , lactic acid bacteria. And because NBT can also be applied for genome modification of microorganisms, the impact that these technologies could have in regulations worldwide will also impact the development and commercialization of new strains of microorganisms with enhanced characteristics.

Biomedical applications

Biomedical sciences have been systematically exploiting genetic modification for new therapeutic approaches since the 90's. The practical potential of these approaches comes from complementary fields in continuous development: the design and optimization of in vivo oligonucleotide-based therapies, engineering of viral vectors for gene therapy and the introduction of gene-edited cells generated ex vivo into patients to treat certain conditions, especially blood-related diseases [ 68 , 69 , 70 ]. Importantly, these gene editing techniques have been employed to modify coding or non-coding regulatory sequences and also epigenetic modulators of gene expression ( 71 , 72 ). Noteworthy, the engineered viral vectors and the genetically modified cells can be considered GMOs or products of them, depending on the methodology used.

Despite increasing knowledge and proof-of-concept studies, only a few gene-editing therapies have been approved by FDA and are currently available to patients [ 69 , 73 ]. Most of these therapies are based on chimeric antigen receptor T cells (CAR-T cells), modifying T lymphocytes ex vivo with viral vectors to infuse them back into the patient’s bloodstream to treat multiple myeloma or B-cell lymphoma. Trade names for these FDA-approved CAR-T cells therapies are Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta. Besides the ex vivo approach, Imlygic is the only case of local administration of viral particles to transduce cancer cells, leading to oncolysis for melanoma treatment. Luxturna and Zolgensma are adeno-associated virus (AAV) gene therapies for RPE65 mutation-associated retinal dystrophy and spinal muscular atrophy (SMA), replacing the dysfunctional alleles of the RPE65 or SMN1 gene, respectively, with their functional copies [ 74 , 75 ]. These two gene-replacing AAV therapies constitute the only approved cases for gene editing of the nervous system.

Controversially, the patient’s somatic cells transduced in gene therapy administration can also be considered as GMOs, since they meet the definition of the Cartagena protocol, as long as they harbour a new combination of genetic material through the use of modern biotechnology. For example, Luxturna and Zolgensma viral vectors replace the dysfunctional alleles of the RPE65 and SMN1 genes in retina or central nervous system nerve cells, respectively. This results in genetically modified somatic cells. How will GMO regulation take these events into account? This question is still open for debate, as regulatory frameworks keep pace with new technologies and applications.

Beside genome edition approach to develop therapeutic interventions, targeting gene expression has also been tested by meanings of RNA-based therapies [ 76 ]. Contrary to the case of some viruses, DNA but no RNA is considered as the genetic material in humans and, thus, RNA use and/or modification would not be regarded as LMOs by Cartagena protocol [ 77 ]. Nevertheless, nucleic acid therapies based on RNA have been proved useful to treat several diseases and their regulation could fall under the terms of genetic modification if the case arises. These therapies include vaccines, being COVID-19 messenger RNA (mRNA)-based ones the most widespread employed up to date [ 78 , 79 ]. One of the main advantages of RNA therapy is the reduced genotoxicity due to lack of integration into the genome [ 76 ]. Moreover, due to the diverse roles of RNA molecules in cell biology, including modulation of transcription, mRNA processing, translation and protein homeostasis, is possible to target specific metabolic pathways without carrying the modification into daughter cells [ 76 , 80 , 81 , 82 ]. RNA-based therapies have been approved by FDA to treat several diseases, such as atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia [ 83 , 84 ], SMA [ 85 ], Duchenne muscular dystrophy [ 86 , 87 ], hereditary transthyretin-mediated amyloidosis (hATTR) [ 88 ], hepatic porphyria [ 89 ] or neovascular age-related macular degeneration [ 90 ]. These therapies relay on antisense oligonucleotide, small interfering RNA (siRNA) or modified RNA (aptamers) tools [ 76 ].

Not only human cells are the main target for gene editing or gene expression modification in pathological contexts. The use of biomaterials in medicine has opened new avenues for GMOs and/or their products in biomedical treatments. Spanning from tissue engineering, drug delivery, organ transplantation, artificial organs, dental implants, bone replacement to prosthetics, among others, biomaterials serve as a functional platform to couple GMOs to human physiology. Stratagraft and Maci are FDA-approved cellular therapies acting as scaffolds for tissue regeneration indicated for knee cartilage defects or deep partial-thickness thermal burns, respectively. Despite not being genetically modified, these decellularized collagen scaffolds open the way for existing and developing “functional” biomaterials that express recombinant proteins such as growth factors, immune modulators or extracellular matrix components [ 91 , 92 , 93 ]. Following this line, functional photosynthetic scaffolds for dermal regeneration have been tested using Synechococcus sp. transgenic cyanobacteria that synthetize hyaluronic acid or modified Chlamydomonas reinhardtii microalgae that expresses the vascular endothelial growth factor (VEGF) [ 92 , 93 ].

GMOs for climate change challenge

Notwithstanding the potential of GMOs to face big challenges in human activities, regulatory frameworks and public opinion continue to play a critical role in their development and implementation. Such is the case of climate change solutions based on GMOs. It has been proposed that biotech crops can reduce the greenhouse gases (GHG) emission by means of optimizing land-use, increasing yields, and decreasing the chemical, energy and transport resources involved in agricultural production [ 94 ]. Herbicide and insect resistant traits have allowed reduced levels of pesticide used worldwide estimated to an extent of 8.3% compared to the amount needed on the same area planted with conventional counterpart crops [ 95 ]. This have led to reduced, and even remove, tillage between agricultural cycles because farmers no longer need to remove weeds mechanically neither separate pathogen-infected plants [ 95 ]. Due to this continuous use of land for crop growth, there is more plant mass available to change atmospheric CO 2 fluxes towards the soil in a phenomenon termed carbon sequestration [ 96 ]. Moreover, insect resistant traits have reduced the need for insecticide spraying, decreasing the fuel consumption associated with this process worldwide. In top of that, some authors argue that GM crops require less agricultural surface to be produced, also decreasing the fuel demand for machinery associated with larger farm area [ 94 , 95 ]. It has been estimated that, depending on the region, cultivation of maize, soybean or rotation of both, have a carbon sequestration between 102 and 250 kg of carbon per hectare per year [ 95 ].

European geographical conditions are advantageous for growing the most commercialized GM crops. It has recently been estimated that GMOs adoption in the EU will increase yields and lower pesticide utilization [ 94 ]. Importantly, the EU imports more than 45 million tons of maize and soybean, for food and feed, from the Americas (mainly USA, Argentina and Brazil). Higher yields and increased local production due to hypothetical adoption of GM crops in the EU will reduce imports and therefore the environmental impact worldwide. This scenario could lead to a reduction in GHG emissions by 33 million tons of CO 2 equivalents per year [ 94 ]. However, as stated above, Europe is the most reluctant region to GMOs adoption due to its strict regulatory framework and overall consumer rejection. As long as these legal and sociological features hold their positions, little progress will be made not only in assessing GM crops potential to tackle climate change, but also in scientific research for European crops breeding and global solutions. Nevertheless, a future turn towards uses of modern biotechnology could be expected as the presence of GM ingredients in food and drinks and gene editing technology are not even at the top three main concerns regarding food security, according to the last Eurobarometer survey assessing food security perception [ 97 , 98 ].

In addition to GHG emissions reduction and crop yield and nutrient content optimization, plant adaptation to the changing environment is one of the main concerns in climate change context. Besides conventional breeding, genetic modification has been tested to enhance plant resistance to higher global temperatures and lower water availability. In this scenario, the drought-tolerance trait has become an attractive research focus for crop development [ 99 , 100 ]. Soybean and wheat, two of the most consumed crops, have been modified to express sunflower Hahb-4 transcription factor related to water stress responses [ 101 ]. These transgenic crops (termed HB4 crops) are currently commercially available and do not differ in nutritional content compared to their non-transgenic counterparts [ 102 , 103 , 104 ]. Under field conditions, HB4 soybean has increased seed yield and water use efficiency in dry environments compared to non-transgenic crops [ 105 ]. Experience in the USA has shown that one of the few drought-tolerant commercial maize led to increased yields in water-limited environments compared to conventional hybrids in the same regions, with yield differences ranging from 1 to 9.7% [ 106 , 107 ]. The understanding of water management and root systems in plant biology is a key aspect for the development of this trait [ 100 ]. In fact, modifying rice root architecture-related locus Dro1 , increased root depth and provided better yields under water-limited in vitro or field environments [ 108 , 109 ]. Another relevant path to stress resistance and drought tolerance is abscisic acid (ABA) hormone signaling, being a potential target for genetic modification in order to obtain new varieties [ 100 ]. Transgenic canola harboring antisense construct against farnesyltransferase (ERA1), an ABA signaling down-regulator factor, is able to increase seed yields under water-limited field conditions during flowering time [ 110 ]. Indeed, complementary approaches modifying root systems, ABA signaling and early-flowering strategies could be useful to cope with warm seasons, avoiding exposition to heat and reduced water levels in drought risk regions [ 99 , 100 , 110 , 111 , 112 ].

Conclusions

The development of new genetic editing strategies and technologies such as NBT has brought opportunities to face critical challenges in different aspects of human life. From meeting the needs for food and feed to development of industries and new therapeutic approaches, the enormous potential of LMOs could be a game-changing tool to thrive in a rapidly changing world. Updating, understanding and discussing this scientific knowledge will have a profound impact on regulatory frameworks across the world as seen in the evolution of different legal styles that has been constructed over the years. Noteworthy, the comparison of these frameworks shows that several cultural and local aspects, such as environmental or economic factors, are as important as technology development to rise up to these challenges.

Availability of data and materials

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Abbreviations

Adeno-associated virus

Abscisic acid

Chimeric antigen receptor T

Clustered regularly interspaced short palindromic repeats

Double-strand break

Deoxyribonucleic acid

Greenhouse gases

Genetically modified

Genetically modified organism

Homology-directed repair

Herbicide tolerance

Insect resistance

Non-homologous end joining

Living modified organism

Open reading frame

Plant with novel traits

Reverse transcriptase

Spinal muscular atrophy

Transcription activator-like effector

Transcription activator-like effector nuclease

Vascular endothelial growth factor

Zinc finger domain-coupled nucleases

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Acknowledgements

This work was funded by Dicyt-USACH, Universidad de Santiago de Chile [grant USA1856_2_1_4] to PR, ANID/FONDECYT [grant 11220533] to EIKP, and ANID/FONDECYT [grant 1201104] and ANID/FONDEF IDeA I+D [grant ID21I10198] to CM.

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Eduardo I. Kessi-Pérez & Claudio Martínez

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Conceptualization, EIKP and CM; investigation, PR; data curation, PR; writing—original draft preparation, PR; writing—review and editing, PR, EIKP and CM; visualization, PR and EIKP; supervision, EIKP and CM; project administration, CM; funding acquisition, CM. All authors read and approved the final manuscript.

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Rozas, P., Kessi-Pérez, E.I. & Martínez, C. Genetically modified organisms: adapting regulatory frameworks for evolving genome editing technologies. Biol Res 55 , 31 (2022). https://doi.org/10.1186/s40659-022-00399-x

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Science and History of GMOs and Other Food Modification Processes

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How has genetic engineering changed plant and animal breeding?

Did you know.

Genetic engineering is often used in combination with traditional breeding to produce the genetically engineered plant varieties on the market today.

For thousands of years, humans have been using traditional modification methods like selective breeding and cross-breeding to breed plants and animals with more desirable traits. For example, early farmers developed cross-breeding methods to grow corn with a range of colors, sizes, and uses. Today’s strawberries are a cross between a strawberry species native to North America and a strawberry species native to South America.

Most of the foods we eat today were created through traditional breeding methods. But changing plants and animals through traditional breeding can take a long time, and it is difficult to make very specific changes. After scientists developed genetic engineering in the 1970s, they were able to make similar changes in a more specific way and in a shorter amount of time.

A Timeline of Genetic Modification in Agriculture

A Timeline of Genetic Modification in Modern Agriculture

Circa 8000 BCE: Humans use traditional modification methods like selective breeding and cross-breeding to breed plants and animals with more desirable traits.

1866: Gregor Mendel, an Austrian monk, breeds two different types of peas and identifies the basic process of genetics.

1922: The first hybrid corn is produced and sold commercially.

1940: Plant breeders learn to use radiation or chemicals to randomly change an organism’s DNA.

1953: Building on the discoveries of chemist Rosalind Franklin, scientists James Watson and Francis Crick identify the structure of DNA.

1973: Biochemists Herbert Boyer and Stanley Cohen develop genetic engineering by inserting DNA from one bacteria into another.

1982: FDA approves the first consumer GMO product developed through genetic engineering: human insulin to treat diabetes.

1986: The federal government establishes the Coordinated Framework for the Regulation of Biotechnology. This policy describes how the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) work together to regulate the safety of GMOs.

1992: FDA policy states that foods from GMO plants must meet the same requirements, including the same safety standards, as foods derived from traditionally bred plants.

1994: The first GMO produce created through genetic engineering—a GMO tomato—becomes available for sale after studies evaluated by federal agencies proved it to be as safe as traditionally bred tomatoes.

1990s: The first wave of GMO produce created through genetic engineering becomes available to consumers: summer squash, soybeans, cotton, corn, papayas, tomatoes, potatoes, and canola. Not all are still available for sale.

2003: The World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations develop international guidelines and standards to determine the safety of GMO foods.

2005: GMO alfalfa and sugar beets are available for sale in the United States.

2015: FDA approves an application for the first genetic modification in an animal for use as food, a genetically engineered salmon.

2016: Congress passes a law requiring labeling for some foods produced through genetic engineering and uses the term “bioengineered,” which will start to appear on some foods.

2017: GMO apples are available for sale in the U.S.

2019: FDA completes consultation on first food from a genome edited plant.

2020 : GMO pink pineapple is available to U.S. consumers.

2020 : Application for GalSafe pig was approved.

How are GMOs made?

“GMO” (genetically modified organism) has become the common term consumers and popular media use to describe foods that have been created through genetic engineering. Genetic engineering is a process that involves:

• Identifying the genetic information—or “gene”—that gives an organism (plant, animal, or microorganism) a desired trait
• Copying that information from the organism that has the trait
• Inserting that information into the DNA of another organism
• Then growing the new organism

How Are GMOs Made? Fact Sheet

Making a GMO Plant, Step by Step

The following example gives a general idea of the steps it takes to create a GMO plant. This example uses a type of insect-resistant corn called “Bt corn.” Keep in mind that the processes for creating a GMO plant, animal, or microorganism may be different.

To produce a GMO plant, scientists first identify what trait they want that plant to have, such as resistance to drought, herbicides, or insects. Then, they find an organism (plant, animal, or microorganism) that already has that trait within its genes. In this example, scientists wanted to create insect-resistant corn to reduce the need to spray pesticides. They identified a gene in a soil bacterium called Bacillus thuringiensis (Bt) , which produces a natural insecticide that has been in use for many years in traditional and organic agriculture.

After scientists find the gene with the desired trait, they copy that gene.

For Bt corn, they copied the gene in Bt that would provide the insect-resistance trait.

Next, scientists use tools to insert the gene into the DNA of the plant. By inserting the Bt gene into the DNA of the corn plant, scientists gave it the insect resistance trait.

This new trait does not change the other existing traits.

In the laboratory, scientists grow the new corn plant to ensure it has adopted the desired trait (insect resistance). If successful, scientists first grow and monitor the new corn plant (now called Bt corn because it contains a gene from Bacillus thuringiensis) in greenhouses and then in small field tests before moving it into larger field tests. GMO plants go through in-depth review and tests before they are ready to be sold to farmers.

The entire process of bringing a GMO plant to the marketplace takes several years.

Learn more about the process for creating genetically engineered microbes and genetically engineered animals .

What are the latest scientific advances in plant and animal breeding?

Scientists are developing new ways to create new varieties of crops and animals using a process called genome editing . These techniques can make changes more quickly and precisely than traditional breeding methods.

There are several genome editing tools, such as CRISPR . Scientists can use these newer genome editing tools to make crops more nutritious, drought tolerant, and resistant to insect pests and diseases.

Learn more about Genome Editing in Agricultural Biotechnology .

How GMOs Are Regulated in the United States

GMO Crops, Animal Food, and Beyond

How GMO Crops Impact Our World

www.fda.gov/feedyourmind

Articles on Genetically Modified Organisms

Displaying 1 - 20 of 61 articles.

Genetically modified crops may be a solution to hunger - why there is scepticism in Africa

Ademola Adenle , Technical University of Denmark

What’s the latest on GMOs and gene-edited foods – and what are the concerns? An expert explains

Karen Massel , The University of Queensland

A mammoth meatball hints at a future of exotic lab-grown meats, but the reality will be far more boring, and rife with problems

Hallam Stevens , James Cook University

Kenya has lifted its ban on genetically modified crops: the risks and opportunities

Benard Odhiambo Oloo , Egerton University

Gene-edited crops: expert Q+A on what field trials could mean for the future of food

Guy Poppy , University of Southampton

Calling the latest gene technologies ‘natural’ is a semantic distraction — they must still be regulated

Jack Heinemann , University of Canterbury ; Brigitta Kurenbach , University of Canterbury ; Deborah Paull , University of Canterbury , and Sophie Walker , University of Canterbury

From this week, every mainland Australian state will allow genetically modified crops. Here’s why that’s nothing to fear

Daniel Tan , University of Sydney

Battling misinformation wars in Africa: applying lessons from GMOs to  COVID-19

Edward Mabaya , Cornell University ; Ifeanyi M Nsofor , George Washington University , and Sarah Evanega , Cornell University

The quest for delicious decaf coffee could change the appetite for GMOs

Thomas Merritt , Laurentian University

Plants might be able to tell us about the location of dead bodies, helping families find missing people

Neal Stewart , University of Tennessee

Ethicists: We need more flexible tools for evaluating gene-edited  food

Christopher J. Preston , University of Montana and Trine Antonsen , University of Tromsø

The Philippines has rated ‘Golden Rice’ safe, but farmers might not plant it

Glenn Davis Stone , Sweet Briar College and Dominic Glover , Institute of Development Studies

Confusion at the fish counter: How to eat fish responsibly

Jenny Weitzman , Dalhousie University

CRISPR isn’t just for editing human embryos, it also works for plants and bugs: 5 essential reads

Bijal Trivedi, The Conversation

GM crop ruling shows why the EU’s laws are wholly inadequate

Ottoline Leyser , University of Cambridge

Gene drives accelerate evolution – but we need brakes

Yu-Hsuan Tsai , Cardiff University and Tony Perry , University of Bath

Mandatory labels with simple disclosures reduced fears of GE foods in Vermont

Jane Kolodinsky , University of Vermont

These CRISPR-modified crops don’t count as GMOs

Yi Li , University of Connecticut

Growing food in the post-truth  era

Alana Mann , University of Sydney

Beyond just promise, CRISPR is delivering in the lab today

Ian Haydon , University of Washington

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Genetic Engineering and Society Center

What to know about gmos.

September 29, 2021 | Guest Author

Five Questions with Biotech Policy Expert Jennifer Kuzma

by: Nash Dunn

During the past 30 years, the acronym “GMO” has reached the mainstream. You’re likely to hear it in conversation, advertising and, these days, the marketplace.

But what exactly are genetically modified organisms? How are they developed and regulated? How can they be improved and advanced, safely?

These aren’t just questions for biologists and engineers. NC State is home to social scientists and humanists who explore governance, communication, and ethical, historical and societal implications of emerging biotechnologies. Professor Jennifer Kuzma is a leader in this area.

The Goodnight-NCGSK Foundation Distinguished Professor in the School of Public and International Affairs, Kuzma is the co-founder and co-director of NC State’s Genetic Engineering and Society Center .

During the past two decades, she’s contributed more than 150 scholarly publications in the realm of biotechnology regulation and has held positions on numerous national and international committees. In 2018, the American Association for the Advancement of Science named Kuzma an honorary fellow, one of several distinctions she’s earned in her career.

Jennifer Kuzma

What are genetically modified foods? Or GMOs?

• Genetically modified organisms (GMOs) are animals, plants or microorganisms that have been modified using modern biotechnology techniques.
• Genetically modified foods (GM foods) are foods derived from GMOs.

GMOs and GM foods can contain foreign genes, or in other words, genes coming from an unrelated species. If the gene you are engineering into a host species comes from an unrelated species, scientists use the term transgenic. If the engineered genes come from related species, scientists use the term cisgenic.

Gene editing is a subset of biotechnology that uses enzymes to cut the genome in a very specific location, in order to change a gene in some way.

For example, analogous to changing a letter in a word, biotechnologists can use enzymes that cut at a specific location and rely on the cell’s own repair system to form a small mutation. To make larger changes, scientists can also introduce an engineered DNA template, and cells will copy that sequence into the site for more substantial genetic “edits” (analogous to introducing a new word or sentence in a paragraph).

CRISPR-Cas9 is a new type of gene editing that makes it easier to introduce small or larger genetic changes into a particular gene in a crop. After the edit is made, the foreign genes can be removed from the plant or animal through standard breeding so that only the edited gene will remain. Thus, not all GMOs contain foreign genes.

What GM foods can be found on the market?  

In the first decades of agricultural biotechnology (1990-2010), GM foods mainly involved large commodity crops like soybeans, corn and cotton. The two traits engineered into these crops were typically genes involved in pest resistance or herbicide tolerance.

For example, most pest-resistant GM crops contained genes from the bacterium Bacillus thuringiensis , also known as “Bt.” These genes express proteins that poke holes in insects’ guts and kill them. In other words, the pesticide is built into Bt crops through genetic engineering and therefore, under some conditions, farmers can spray fewer chemical pesticides. Most of these GM crops went to animal feed, cotton, corn and soybean oil or corn or soybean meal.

Today, some whole sweet corn with Bt or herbicide-tolerant genes is on the market for human consumption, as are some viral-resistant papaya and squash. Also on the market is the Arctic Apple, a GM apple that resists browning.

Only a few GM animals have been approved for human consumption by the U.S. Food and Drug Administration (FDA) — the AquAdvantage salmon that contains a growth hormone for faster growth and a GM GalSafe pig for lower allergenicity and reduced tissue rejection for transplantation.

Scientists mark the advent of gene editing as the second generation of GMOs. Several gene-edited crops have been reviewed by the U.S. Department of Agriculture (USDA) for agricultural planting. The only gene-edited crop reviewed for human consumption by the FDA is a high oleic acid soybean, which has a healthier profile of oil and better food processing characteristics. It’s on the market now.

How can I find info about GM crops in the food supply?

In general, it’s difficult for consumers to find out what GM foods are on the market because they aren’t currently labeled in the U.S. Also, different federal agencies regulate GM crops, and there’s not a one-stop shop for finding information about what’s been approved. And even if a GM crop is approved through regulation, it might not be on the market yet.

Community-Led Governance For Gene-Edited Crops

In a recent paper in Science magazine, Kuzma and scholar Khara Grieger call for a public-friendly repository of GM and gene-edited crops — so consumers can know the general types and uses in the marketplace.

Starting in 2022, GM crops with foreign DNA will require labeling in the U.S. to comply with the new National Bioengineered Foods Disclosure Law and Standards. However, the new law excludes GM foods that are cisgenic, or those that don’t contain foreign DNA (like oils derived from transgenic GM crops). Furthermore, the labels will use the term “bioengineered” instead of GM, which might be less familiar to consumers. Biotech policy expert Greg Jaffe and I critiqued these and other requirements in a recent article , asking whether it might cause greater confusion among consumers.

If they choose to, consumers can avoid GM and gene-edited foods by purchasing USDA certified organic foods. Some organizations have also instituted “non-GM” labels like the non-GMO project seal.

Are GM foods safe?

As a broad category, GM foods are neither “safe” or “unsafe,” and the scientific consensus is they need to be reviewed on a case by case basis. We can say, however, that current GM foods on the market have not exhibited increased toxicity or allergenicity and have been screened for equivalent nutritional content.

GM foods on the market have been reviewed through the FDA’s voluntary consultation process. So far, there have been no observed adverse health effects from humans consuming GM foods. It is possible that in the future some GM foods would be developed with changed nutritional makeup or increased toxicity or allergenicity.

What is NC State doing to address genetic engineering and GMOs?

NC State’s Genetic Engineering and Society Center has become an international leader in research, scholarship, education and engagement on the societal implications of genetic engineering and emerging biotechnologies.

The GES center has more than 50 affiliated faculty, houses a graduate minor and several academic courses, and works with nonprofit, governmental, academic and industry partners on projects to consider the broader societal context, science, technology and safety of GMOs.

Explore NC State’s international hub of interdisciplinary research, engaged scholarship and inclusive dialogues surrounding opportunities and challenges associated with genetic engineering and society.

In addition to the center, NC State sponsors a Genetic Engineering and Society faculty cluster through the Chancellor’s Faculty Excellence Program. This interdisciplinary group of scholars helps hire top faculty and researches cultural, policy and economic aspects of GMOs.

All of this work helps ensure the safe, responsible and equitable development of emerging biotechnologies. This is an increasingly important task, one needed to realize potential benefits to sustainability, ensuring an adequate food supply, reducing illness and disease, and conserving our biodiversity.

This article was originally published in the Fall 2021 issue of the CHASS digital magazine,  Accolades at https://chass.ncsu.edu/news/2021/09/29/what-to-know-about-gmos/

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What is a genetically modified organism?

A genetically modified organism (GMO) is an organism whose DNA has been modified in the laboratory in order to favour the expression of desired physiological traits or the production of desired biological products.

Why are genetically modified organisms important?

Genetically modified organisms (GMOs) provide certain advantages to producers and consumers. Modified plants, for example, can at least initially help protect crops by providing resistance to a specific disease or insect, ensuring greater food production. GMOs are also important sources of medicine.

Assessing the environmental safety of genetically modified organisms (GMOs) is challenging. While modified crops that are resistant to herbicides can reduce mechanical tillage and hence soil erosion, engineered genes from GMOs can potentially enter into wild populations, genetically modified crops may encourage increased use of agricultural chemicals, and there are concerns that GMOs may cause inadvertent losses in biodiversity .

The question of whether genetically modified (GM) crops should be grown is one that has been debated for decades. Some people argue that GM crops can lower the price of food, increase nutritional content, and thus help to alleviate world hunger, while others argue that the genetic makeup of plants may introduce toxins or trigger allergic reactions. Learn more at ProCon.org.

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genetically modified organism (GMO) , organism whose genome has been engineered in the laboratory in order to favour the expression of desired physiological traits or the generation of desired biological products. In conventional livestock production, crop farming, and even pet breeding, it has long been the practice to breed select individuals of a species in order to produce offspring that have desirable traits. In genetic modification, however, recombinant genetic technologies are employed to produce organisms whose genomes have been precisely altered at the molecular level, usually by the inclusion of genes from unrelated species of organisms that code for traits that would not be obtained easily through conventional selective breeding .

Genetically modified organisms (GMOs) are produced using scientific methods that include recombinant DNA technology and reproductive cloning . In reproductive cloning, a nucleus is extracted from a cell of the individual to be cloned and is inserted into the enucleated cytoplasm of a host egg (an enucleated egg is an egg cell that has had its own nucleus removed). The process results in the generation of an offspring that is genetically identical to the donor individual. The first animal produced by means of this cloning technique with a nucleus from an adult donor cell (as opposed to a donor embryo) was a sheep named Dolly , born in 1996. Since then a number of other animals, including pigs , horses , and dogs , have been generated by reproductive cloning technology . Recombinant DNA technology, on the other hand, involves the insertion of one or more individual genes from an organism of one species into the DNA (deoxyribonucleic acid) of another. Whole-genome replacement, involving the transplantation of one bacterial genome into the “cell body,” or cytoplasm, of another microorganism, has been reported, although this technology is still limited to basic scientific applications.

GMOs produced through genetic technologies have become a part of everyday life, entering into society through agriculture, medicine , research, and environmental management. However, while GMOs have benefited human society in many ways, some disadvantages exist; therefore, the production of GMOs remains a highly controversial topic in many parts of the world.

Genetically modified (GM) foods were first approved for human consumption in the United States in 1994, and by 2014–15 about 90 percent of the corn , cotton , and soybeans planted in the United States were GM. By the end of 2014, GM crops covered nearly 1.8 million square kilometres (695,000 square miles) of land in more than two dozen countries worldwide. The majority of GM crops were grown in the Americas.

Engineered crops can dramatically increase per area crop yields and, in some cases, reduce the use of chemical insecticides . For example, the application of wide-spectrum insecticides declined in many areas growing plants, such as potatoes , cotton, and corn, that were endowed with a gene from the bacterium Bacillus thuringiensis , which produces a natural insecticide called Bt toxin . Field studies conducted in India in which Bt cotton was compared with non-Bt cotton demonstrated a 30–80 percent increase in yield from the GM crop. This increase was attributed to marked improvement in the GM plants’ ability to overcome bollworm infestation, which was otherwise common. Studies of Bt cotton production in Arizona, U.S., demonstrated only small gains in yield—about 5 percent—with an estimated cost reduction of $25–$65 (USD) per acre owing to decreased pesticide applications. In China, where farmers first gained access to Bt cotton in 1997, the GM crop was initially successful. Farmers who had planted Bt cotton reduced their pesticide use by 50–80 percent and increased their earnings by as much as 36 percent. By 2004, however, farmers who had been growing Bt cotton for several years found that the benefits of the crop eroded as populations of secondary insect pests, such as mirids, increased. Farmers once again were forced to spray broad-spectrum pesticides throughout the growing season , such that the average revenue for Bt growers was 8 percent lower than that of farmers who grew conventional cotton. Meanwhile, Bt resistance had also evolved in field populations of major cotton pests, including both the cotton bollworm ( Helicoverpa armigera ) and the pink bollworm ( Pectinophora gossypiella ).

Other GM plants were engineered for resistance to a specific chemical herbicide , rather than resistance to a natural predator or pest. Herbicide-resistant crops (HRC) have been available since the mid-1980s; these crops enable effective chemical control of weeds , since only the HRC plants can survive in fields treated with the corresponding herbicide. Many HRCs are resistant to glyphosate (Roundup), enabling liberal application of the chemical, which is highly effective against weeds. Such crops have been especially valuable for no-till farming, which helps prevent soil erosion. However, because HRCs encourage increased application of chemicals to the soil, rather than decreased application, they remain controversial with regard to their environmental impact. In addition, in order to reduce the risk of selecting for herbicide-resistant weeds, farmers must use multiple diverse weed-management strategies.

Another example of a GM crop is golden rice , which originally was intended for Asia and was genetically modified to produce almost 20 times the beta- carotene of previous varieties. Golden rice was created by modifying the rice genome to include a gene from the daffodil Narcissus pseudonarcissus that produces an enzyme known as phyotene synthase and a gene from the bacterium Erwinia uredovora that produces an enzyme called phyotene desaturase. The introduction of these genes enabled beta-carotene, which is converted to vitamin A in the human liver, to accumulate in the rice endosperm —the edible part of the rice plant—thereby increasing the amount of beta-carotene available for vitamin A synthesis in the body. In 2004 the same researchers who developed the original golden rice plant improved upon the model, generating golden rice 2, which showed a 23-fold increase in carotenoid production.

Another form of modified rice was generated to help combat iron deficiency, which impacts close to 30 percent of the world population. This GM crop was engineered by introducing into the rice genome a ferritin gene from the common bean , Phaseolus vulgaris , that produces a protein capable of binding iron, as well as a gene from the fungus Aspergillus fumigatus that produces an enzyme capable of digesting compounds that increase iron bioavailability via digestion of phytate (an inhibitor of iron absorption). The iron-fortified GM rice was engineered to overexpress an existing rice gene that produces a cysteine-rich metallothioneinlike (metal-binding) protein that enhances iron absorption.

A variety of other crops modified to endure the weather extremes common in other parts of the globe are also in production.

ENCYCLOPEDIC ENTRY

Genetically modified organisms.

A genetically modified organism contains DNA that has been altered using genetic engineering. Genetically modified animals are mainly used for research purposes, while genetically modified plants are common in today’s food supply.

Biology, Ecology, Genetics, Health

Photo of a genetically engineered Salmon. Created so that it continuously produces growth hormones and can be sold as a full size fish after 18 months instead of 3 years.

Photograph by Paulo Oliveira/Alamy Stock Photo

A genetically modified organism (GMO) is an animal, plant, or microbe whose DNA has been altered using genetic engineering techniques.

For thousands of years, humans have used breeding methods to modify organisms . Corn, cattle, and even dogs have been selectively bred over generations to have certain desired traits . Within the last few decades, however, modern advances in biotechnology have allowed scientists to directly modify the DNA of micro organisms , crops, and animals.

Conventional methods of modifying plants and animals— selective breeding and crossbreeding —can take a long time. Moreover, selective breeding and crossbreeding often produce mixed results, with unwanted traits appearing alongside desired characteristics. The specific targeted modification of DNA using biotechnology has allowed scientists to avoid this problem and improve the genetic makeup of an organism without unwanted characteristics tagging along.

Most animals that are GMOs are produced for use in laboratory research. These animals are used as “models” to study the function of specific genes and, typically, how the genes relate to health and disease. Some GMO animals, however, are produced for human consumption. Salmon, for example, has been genetically engineered to mature faster, and the U.S. Food and Drug Administration has stated that these fish are safe to eat.

GMOs are perhaps most visible in the produce section. The first genetically engineered plants to be produced for human consumption were introduced in the mid-1990s. Today, approximately 90 percent of the corn, soybeans, and sugar beets on the market are GMOs. Genetically engineered crops produce higher yields, have a longer shelf life, are resistant to diseases and pests, and even taste better. These benefits are a plus for both farmers and consumers. For example, higher yields and longer shelf life may lead to lower prices for consumers, and pest-resistant crops means that farmers don’t need to buy and use as many pesticides to grow quality crops. GMO crops can thus be kinder to the environment than conventionally grown crops.

Genetically modified foods do cause controversy, however. Genetic engineering typically changes an organism in a way that would not occur naturally. It is even common for scientists to insert genes into an organism from an entirely different organism. This raises the possible risk of unexpected allergic reactions to some GMO foods. Other concerns include the possibility of the genetically engineered foreign DNA spreading to non-GMO plants and animals. So far, none of the GMOs approved for consumption have caused any of these problems, and GMO food sources are subject to regulations and rigorous safety assessments.

In the future, GMOs are likely to continue playing an important role in biomedical research. GMO foods may provide better nutrition and perhaps even be engineered to contain medicinal compounds to enhance human health. If GMOs can be shown to be both safe and healthful, consumer resistance to these products will most likely diminish.

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• Mara Almeida   ORCID: orcid.org/0000-0002-0435-6296 1 &
• Robert Ranisch   ORCID: orcid.org/0000-0002-1676-1694 2 , 3  

Humanities and Social Sciences Communications volume  9 , Article number:  139 ( 2022 ) Cite this article

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• Medical humanities
• Science, technology and society

Genetic engineering has provided humans the ability to transform organisms by direct manipulation of genomes within a broad range of applications including agriculture (e.g., GM crops), and the pharmaceutical industry (e.g., insulin production). Developments within the last 10 years have produced new tools for genome editing (e.g., CRISPR/Cas9) that can achieve much greater precision than previous forms of genetic engineering. Moreover, these tools could offer the potential for interventions on humans and for both clinical and non-clinical purposes, resulting in a broad scope of applicability. However, their promising abilities and potential uses (including their applicability in humans for either somatic or heritable genome editing interventions) greatly increase their potential societal impacts and, as such, have brought an urgency to ethical and regulatory discussions about the application of such technology in our society. In this article, we explore different arguments (pragmatic, sociopolitical and categorical) that have been made in support of or in opposition to the new technologies of genome editing and their impact on the debate of the permissibility or otherwise of human heritable genome editing interventions in the future. For this purpose, reference is made to discussions on genetic engineering that have taken place in the field of bioethics since the 1980s. Our analysis shows that the dominance of categorical arguments has been reversed in favour of pragmatic arguments such as safety concerns. However, when it comes to involving the public in ethical discourse, we consider it crucial widening the debate beyond such pragmatic considerations. In this article, we explore some of the key categorical as well sociopolitical considerations raised by the potential uses of heritable genome editing interventions, as these considerations underline many of the societal concerns and values crucial for public engagement. We also highlight how pragmatic considerations, despite their increasing importance in the work of recent authoritative sources, are unlikely to be the result of progress on outstanding categorical issues, but rather reflect the limited progress on these aspects and/or pressures in regulating the use of the technology.

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The ability to alter a sequence of genetic material was initially developed in microorganisms during the 1970s and 1980s (for an overview: Walters et al., 2021 ). Since then, technological advances have allowed researchers to alter DNA in different organisms by introducing a new gene or by modifying the sequence of bases in the genome. The manipulation of the genome of living organisms (typically plants) continues a course that science embraced more than 40 years ago, and may ultimately allow, if not deliberately curtailed by societal decisions, the possibility of manipulating and controlling genetic material of other living species, including humans.

Genetic engineering can be used in a diverse range of contexts, including research (e.g., to build model organisms), pharmacology (e.g., for insulin production) and agriculture (e.g., to improve crop resistance to environmental pressures such as diseases, or to increase yield). Beyond these applications, modern genetic engineering techniques such as genome editing technologies have the potential to be an innovative tool in clinical interventions but also outside the clinical realm. In the clinical context, genome editing techniques are expected to help in both disease prevention and in treatment (Porteus, 2019 ; Zhang, 2019 ). Nevertheless, genome editing technology raises several questions, including the implications of its use for human germline cells or embryos, since the technology’s use could facilitate heritable genome editing interventions (Lea and Niakan, 2019 ). This possible use has fuelled a heated debate and fierce opposition, as illustrated by the moratoriums proposed by researchers and international institutions on the use of the technology (Lander et al., 2019 ; Baltimore et al., 2015 ; Lanphier et al., 2015 ). Heritable human germline modifications are currently prohibited under various legislations (Baylis et al., 2020 ; Ledford, 2015 ; Isasi et al., 2016 ; König, 2017 ) and surveys show public concerns about such applications, especially without clear medical justification (e.g., Gaskell et al., 2017 ; Jedwab et al., 2020 ; Scheufele et al., 2017 ; Blendon et al., 2016 ).

To analyse some implications of allowing heritable genome editing interventions in humans, it is relevant to explore underlying values and associated ethical considerations. Building on previous work by other authors (e.g., Coller, 2019 ; de Wert et al., 2018 ; van Dijke et al., 2018 ; Mulvihill et al., 2017 ; Ishii, 2015 ), this article aims to provide context to the debates taking place and critically analyse some of the major pragmatic, categorical and sociopolitical considerations raised to date in relation to human heritable genome editing. Specifically, we explore some key categorical and sociopolitical considerations to underline some of the possible barriers to societal acceptance, key outstanding questions requiring consideration, and possible implications at the individual and collective level. In doing so, we hope to highlight the predominance of pragmatic arguments in the scientific debate regarding the permissible use of heritable genome editing interventions compared to categorical arguments relevant to broader societal debate.

Human genome editing: a brief history of CRISPR/Cas9

Human genome editing is an all-encompassing term for technologies that are aimed at making specific changes to the human genome. In humans, these technologies can be used in embryos or germline cells as well as somatic cells (Box 1 ). Concerning human embryos or germline cells, the intervention could introduce heritable changes to the human genome (Lea and Niakan, 2019 ; Vassena et al., 2016 ; Wolf et al., 2019 ). In contrast, an intervention in somatic cells is not intended to result in changes to the genome of subsequent generations. It is worth noting that intergenerational effects occur only when the modified cells are used to establish a pregnancy which is carried to term. Thus, a distinction has been made between germline genome editing (GGE), which may only affect in vitro embryos in research activity, and heritable genome editing (HGE), which is used in reproductive medicine (e.g., Baylis et al., 2020 ). HGE could be used to prevent the transmission of serious genetic disease; however, other applications could be imagined, e.g., creating genetic resistance or even augmenting human functions.

In the last decade, prominent technical advances in genome engineering methods have taken place, including the zinc-finger nucleases (ZFNs) and TAL effector nucleases (TALENs), making human genome modification a tangible possibility (Gaj et al., 2013 ; Li et al., 2020 ; Gupta and Musunuru, 2014 ). In 2012, a study showed that the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), combined with an enzyme called Cas9, could be used as a genome‐editing tool in human cell culture (Jinek et al., 2012 ). In 2013, the use of CRISPR/Cas9 in mammalian cells was described, demonstrating the application of this tool in the genome of living human cells (Cong et al., 2013 ). In 2014, CRISPR/Cas9 germline modifications were first used in non-human primates, resulting in the birth of gene-edited cynomolgus monkeys (Niu et al., 2014 ). This was followed in 2015 by the first-ever public reported case of genome modification in non-viable human embryos (tripronuclear zygotes) (Liang et al., 2015 ). This study has caused broad concerns in the scientific community (Bosley et al., 2015 ) with leading journals rejecting publication for ethical reasons. Five years after these initial experiments were conducted, more than 10 papers have been published reporting the use of genome editing tools on human preimplantation embryos (for an overview: Niemiec and Howard, 2020 ).

Compared to counterpart genome technologies (e.g., ZFNs and TALENs), CRISPR/Cas9 is considered by many a revolutionary tool due to its efficiency and reduced cost. More specifically, CRISPR/Cas9 seems to provide the possibility of a more targeted and effective intervention in the genome involving the insertion, deletion, or replacement of genetic material (Dance, 2015 ). The potential applicability of CRISPR/Cas9 technique is considered immense, since it can be used on all type of organisms, from bacteria to plants, non-human cells, and human cells (Barrangou and Horvath, 2017 ; Hsu et al., 2014 ; Doudna and Charpentier, 2014 ; Zhang, 2019 ).

Box 1 Difference associated with germline cells and somatic cells.

For the purposes of the analysis presented in this article, one of the main differences is the heritability of genes associated with either type of cell. Germline cells include spermatozoa, oocytes, and their progenitors (e.g., embryonic cells in early development), which can give rise to a new baby carrying a genetic heritage coming from the parents. Thus, germline are those cells in an organism which are involved in the transfer of genetic information from one generation to the next. Somatic cells, conversely, constitute many of the tissues that form the body of living organisms, and do not pass on genetic traits to their progeny.

Germline interventions: the international debate

As a reaction to the 2015 study with CRISPR/Cas9, several commentaries by scientists were published regarding the future use of the technology (e.g., Bosley et al., 2015 ; Lanphier et al., 2015 ; Baltimore et al., 2015 ). Many of them focused on germline applications, due to the possibility of permanent, heritable changes to the human genome and its implications for both individuals and future generations. These commentaries included position statements calling for great caution in the use of genome editing techniques for heritable interventions in humans and suggested a voluntary moratorium on clinical germline applications of CRISPR/Cas9, at least until a broad societal understanding and consensus on their use could be reached (Brokowski, 2018 ; Baltimore et al., 2015 ; Lander, 2015 ). Such calls for a temporary ban were often seen as reminiscent of the “Asilomar ban” on recombinant DNA technology in the mid-1970s (Guttinger, 2017 ). Other commentaries asked for research to be discouraged or halted all together (Lanphier et al., 2015 ). More firmly, the United States (US) National Institutes of Health (NIH) released a statement indicating that the NIH would not fund research using genome editing technologies on human embryos (Collins, 2015 ).

In December 2015, the first International Summit on Human Gene Editing took place, hosted by the US National Academy of Sciences, the US National Academy of Medicine, the UK Royal Society, and the Chinese Academy of Sciences (NASEM). The organizing committee issued a statement about appropriate uses of the technology that included the following: “It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application” (NASEM, 2015 ).

Following this meeting, initiatives from different national bodies were organized to promote debate on the ethical issues raised by the new genome editing technologies and to work towards a common framework governing the development and permissibility of their use in humans. This included an ethical review published in 2016 by the Nuffield Council on Bioethics, addressing conceptual and descriptive questions concerning genome editing, and considering key ethical questions arising from the use of the technology in both human health and other contexts (Nuffield Council on Bioethics, 2016 ). In 2017, a committee on human genome editing set up by the US National Academy of Sciences (NAS) and the National Academy of Medicine (NAM) carried out a so-called consensus study “Human Genome Editing: Science, Ethics, and Governance” (NASEM, 2017 ). This study put forward a series of recommendations on policies and procedures to govern human applications of genome editing. Specifically, the study concluded that HGE could be justified under specific conditions: “In some situations, heritable genome editing would provide the only or the most acceptable option for parents who desire to have genetically related children while minimizing the risk of serious disease or disability in a prospective child” (NASEM, 2017 ). The report stimulated much public debate and was met with support and opposition since it was seen as moving forward on the permissibility of germline editing in the clinical context (Ranisch and Ehni, 2020 ; Hyun and Osborn, 2017 ).

Following the report in 2016, the Nuffield Council on Bioethics published a second report in 2018. Similar to the NASEM 2017 report, this report emphasizes the value of procreative freedom and stresses that in some cases HGE might be the only option for couples to conceive genetically related, healthy offspring. In this document, the Nuffield Council on Bioethics maintains that there are no categorical reasons to prohibit HGE. However, it highlights three kinds of interests that should be recognized when discussing prospective HGE. They are related to individuals directly affected by HGE (parents or children), other parts of society, and future generations of humanity. In this context, two ethical principles are highlighted as important to guide future evaluations of the HGE use in specific interventions: “(...) to influence the characteristics of future generations could be ethically acceptable, provided if, and only if, two principles are satisfied: first, that such interventions are intended to secure, and are consistent with, the welfare of a person who may be born as a consequence, and second, that any such interventions would uphold principles of social justice and solidarity (…)” (Nuffield Council on Bioethics, 2018 ). This report was met with criticism for (implicitly) advocating genetic heritable interventions might be acceptable even beyond the boundaries of therapeutic uses. This is particularly controversial and goes well beyond the position previously reached by the NASEM report (which limited permissible uses of genome editing at preventing the transmission of genetic variants associated to diseases) (Drabiak, 2020 ). On the other hand, others have welcomed the report and, within it, the identification of explicit guiding ethical principles helpful in moving forward the debate on HGE (Gyngell et al., 2019 ).

As a follow-up to the 2015 conference, a second International Summit on Human Gene Editing was scheduled for November 2018 in Hong Kong (National Academies of Sciences, Engineering, and Medicine, 2019 ). The event, convened by the Hong Kong Academy of Sciences, the UK Royal Society, the US National Academy of Sciences and the US National Academy of Medicine, was supposed to focus on the prospects of HGE. Just before the Summit began, news broke that He Jiankui, a Chinese researcher and invited speaker at the Summit, created the world’s first genetically edited babies resulting from the use of CRISPR/Cas9 in embryos (Regalado, 2018 ; Lovell-Badge, 2019 ). Although an independent investigation of the case is still pending, his experiments have now been reviewed in detail by some scholars (e.g., Greely, 2019 , 2021 ; Kirksey, 2020 ; Davies, 2020 ; Musunuru, 2019 ). These experiments were globally criticized, since they did not follow suitable safety procedures or ethical guidelines (Wang and Yang, 2019 ; Lovell-Badge, 2019 ; Krimsky, 2019 ), nor considered the recommendations previously put forward by international reports (NASEM, 2017 ; Nuffield Council on Bioethics, 2018 ) and legal frameworks (Araki and Ishii, 2014 ; Isasi et al., 2016 ). Different reactions were triggered, including another call by scientists for a global moratorium on clinical human genome editing, to allow time for international discussions to take place on its appropriate uses (Lander et al., 2019 ) or an outright ban on the technology (Botkin, 2019 ). There were also calls for a measured analysis of the possible clinical applications of human genome editing, without the imposition of a moratorium (Daley et al., 2019 ; Dzau et al., 2018 ).

Most countries currently have legal frameworks to ban or severely restrict the use of heritable genome editing technologies (Araki and Ishii, 2014 ; Isasi et al., 2016 ; Baylis et al., 2020 ). However, since He’s experiment, the possibility that researchers might still attempt (with some likelihood of success) to use the technology in human embryos, became a growing concern, particularly since some scientists have already announced their interest in further clinical experiments (Cyranoski, 2019 ). For many, He’s experiments highlighted the ongoing risks associated with the use of modern genome editing technology without proper safety protocols and regulatory frameworks at an international level (Ranisch et al., 2020 ). This has triggered the need to develop clear and strict regulations to be implemented if these tools are to be used in the future. This incident also led to the formation of several working groups, including the establishment of an international commission on the Clinical Use of Human Germline Genome Editing set up by the US National Academy of Medicine, the US National Academy of Sciences, and the UK’s Royal Society. In 2020, the commission published a comprehensive report on HGE, proposing a translational pathway from research to clinical use (National Academy of Medicine, National Academy of Sciences, and the Royal Society, 2020 ). Likewise, a global expert Advisory Committee was established by the World Health Organization (WHO) with the goal of developing recommendations on governance mechanisms for human genome editing. Although the committee insisted in an interim recommendation that “it would be irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing” (WHO, 2019 ), it did not express fundamental concerns on the possibility that some forms of HGE will one day become a reality. In 2021, the WHO’s Advisory Committee issued some publications, including a “Framework for governance” report and a “Recommendations” report (WHO, 2021 ). Building on a set of procedural and substantive values and principles, the “Framework for Governance” report discusses a variety of tools and institutions necessary for developing appropriate national, transnational, and international governance and oversight mechanisms for HGE. Specifically, the report considers the full spectrum of possible applications of human genome editing (including epigenetic editing and human enhancement) and addresses specific challenges associated with current, possible and speculative scenarios. These range from somatic gene therapy for the prevention of serious hereditary diseases to potentially more controversial applications reminiscent of the He Jiankui case (e.g., the use of HGE in reproductive medicine outside regulatory controls and oversight mechanisms). Additionally, the “Recommendations” report proposes among other things whistleblowing mechanisms to report illegal or unethical research. It also highlights the need for a global human genome editing registry, that should also cover basic and preclinical research on different applications of genetic manipulation, including HGE. The report also emphasises the need of making possible benefits of human genome editing widely accessible.

The idea of a human genome editing registry has also been supported by the European Group on Ethics in Science and New Technologies (EGE), an advisory board to the President of the European Commission. After an initial statement on genome editing published in 2016, still calling for a moratorium on editing of human embryos (EGE, 2016 ), the EGE published a comprehensive Opinion in 2021 (EGE, 2021 ). Although the focus of this report is on the moral issues surrounding genome editing in animals and plants, HGE is also discussed. Similar to the WHO Advisory Committee, the EGE recommends for HGE not to be introduced prematurely into clinical application and that measures should be taken to prevent HGE’s use for human enhancement.

Overall, when reviewing reports and initiatives produced since 2015, common themes and trajectories can be identified. A key development is the observation that the acceptance of the fundamental permissibility of such interventions appears to be increasing. This constitutes an important change from previous positions, reflecting the fact that human germline interventions have long been considered a ‘red line’ or at least viewed with deep scepticism (Ranisch and Ehni, 2020 ). In particular, while there is agreement that it would be premature to bring HGE into a clinical context, key concerns expressed by authoritative international bodies and committees are now associated with acceptable uses of the technology, rather than its use per se. Consideration is now being given to the conditions and objectives under which germline interventions could be permissible, instead of addressing the fundamental question of whether HGE may be performed at all. The question of permissibility is often linked to the stage of technological development. These developments are remarkable, since the key ethical aspects of genome editing are now frequently confined to questions of safety or cost–benefit ratios, rather than categorical considerations.

Another common issue can also be found in recent reports: the question of involving society in the debate. There is consensus on the fact that the legitimacy and governance of HGE should not be left solely to scientists and other experts but should involve society more broadly. Since germline interventions could profoundly change the human condition, the need for a broad and inclusive public debate is frequently emphasized (Iltis et al., 2021 ; Scheufele et al., 2021 ). The most striking expression of the need for public engagement and a “broad societal consensus” can be found in the final statement by the 2015 International Summit on Human Gene Editing organizing committee, as previously quoted (NASEM, 2015 ). Furthermore, the EGE and others also stresses the need for an inclusive societal debate before HGE can be considered permissible.

The pleas for public engagement are, however, not free of tension. For example, the NASEM’s 2017 report was criticised for supporting HGE bypassing the commitment for the broad societal consensus (Baylis, 2017 ). Regarding HGE, some argue that only a “small but vocal group of scientists and bioethicists now endorse moving forward” (Andorno et al., 2020 ). Serious efforts to engage the public on the permissibility and uses of HGE have yet to be made. This issue not only lacks elaboration on approaches to how successful public participation can occur, but also how stop short of presenting views on how to translate the public’s views into ethical considerations and policy (Baylis, 2019 ).

Potential uses of heritable genome editing technology

HGE is expected to allow a range of critical interventions: (i) preventing the transmission of genetic variants associated with severe genetic conditions (mostly single gene disorders); (ii) reducing the risk of common diseases (mostly polygenic diseases), with the promise of improving human health; and (iii) enhancing human capabilities far beyond what is currently possible for human beings, thereby overcoming human limitations. The identification of different classes of potential interventions has shifted the debate to the applications considered morally permissible beyond the acceptable use of HGE (Dzau et al., 2018 ). Specifically, there are differences in the limits of applicability suggested by some of the key cornerstone publications discussed above. For example, the NASEM ( 2017 ) report suggests limiting the use of HGE to the transmission of genetic variants linked to severe conditions, although in a very regulated context. In a very similar way, the 2020 report from the International Commission on the Clinical Use of Human Germline Genome Editing suggests that the initial clinical use of HGE should be limited to the prevention of serious monogenic diseases. By contrast, the 2018 Nuffield Council on Bioethics Report does not seem to limit the uses of genome editing to specific applications, though suggests that applications should be aligned with fundamental guiding ethical principles and need to have followed public debate (Savulescu et al., 2015 ). The same report also discusses far-reaching and speculative uses of HGE that might achieve “other outcomes of positive value” (Nuffield Council on Bioethics, 2018 ). Some of these more speculative scenarios include “built-in genetic resistance or immunity to endemic disease”; “tolerance for adverse environmental conditions” and “supersenses or superabilities” (Nuffield Council on Bioethics, 2018 , p. 47).

There have been different views on the value of HGE technology. Some consider that HGE should be permissible in the context of therapeutic applications, since it can provide the opportunity to treat and cure diseases (Gyngell et al., 2017 ). For example, intervention in severe genetic disorders is considered as therapeutic and hence morally permissible, or even obligatory. Others consider HGE to be more like a public health measure, which could be used to reduce the prevalence of a disease (Schaefer, 2020 ). However, others maintain that reproductive uses of HGE are not therapeutic because there is no individual in a current state of disease which needs to be treated, rather a prospective individual to be born with a specific set of negative prospective traits (Rulli, 2019 ).

Below, HGE is discussed in the context of reproductive uses and conditions of clinical advantage over existent reproductive technologies. The HGE applications are explored regarding their potential for modifying one or more disease-related genes relevant to the clinical context. Other uses associated with enhancement of physical and mental characteristics, which are considered non-clinical (although the distinction is sometimes blurred), are also discussed.

Single gene disorders

An obvious application of HGE interventions is to prevent the inheritance of genetic variants known to be associated with a serious disease or condition. Its potential use for this purpose could be typically envisaged through assisted reproduction, i.e., as a process to provide reproductive options to couples or individuals at risk of transmitting genetic conditions to their offspring. Critics of this approach often argue that other assisted reproductive technologies (ARTs) and preimplantation screening technologies e.g., preimplantation genetic diagnosis (PGD), not involving the introduction of genetic modifications to germline cells, are already available for preventing the transmission of severe genetic conditions (Lander, 2015 ; Lanphier et al., 2015 ). These existent technologies aim to support prospective parents in conceiving genetically related children without the condition that affect them. In particular, PGD involves the creation of several embryos by in vitro fertilization (IVF) treatment that will be tested for genetic anomalies before being transferred to the uterine cavity (Sermon et al., 2004 ). In Europe, there is a range in the regulation of the PGD technology with most countries having restrictions of some sorts (Soini, 2007 ). The eligibility criteria for the use of PGD also vary across countries, depending on the range of heritable genetic diseases for which it can be used (Bayefsky, 2016 ).

When considering its effectiveness, PGD presents specific limitations, which include the rare cases in which either both prospective parents are homozygous carriers of a recessive genetic disease, or one of the parents is homozygous for a dominant genetic disease (Ranisch, 2020 ). In these cases, all embryos produced by the prospective parents will be affected by the genetic defect, and therefore it will not be possible to select an unaffected embryo after PGD. Currently, beyond adoption of course, the options available for these prospective parents include the use of a third-party egg or sperm donors.

Overall, given the rarity of cases in which it is not applicable, PGD is thought to provide a reliable option to most prospective parents for preventing severe genetic diseases to be transmitted to their offspring, except in very specific cases. HGE interventions have been suggested to be an alternative method to avoid single gene disorders in the rare cases in which selection techniques such as PGD cannot be used (Ranisch, 2020 ). It has also been proposed to use tools such as CRISPR/Cas9 to edit morphologically suitable but genetically affected embryos, and thus increase the number of embryos available for transfer (de Wert et al., 2018 ; Steffann et al., 2018 ). Moreover, HGE interventions are considered by some as a suitable alternative to PGD, even when the use of PGD could be possible. One argument in this respect is that, although not leading to the manifestation of the disease, the selected embryos can still be carriers of it. In this respect, differently from PGD, HGE interventions can be used to eliminate unwanted, potential future consequences of genetic diseases (i.e., by eliminating the critical mutation carried out in the selected embryo), with the advantage of reducing the risks of further propagation of the disease in subsequent future generations (Gyngell et al., 2017 ).

Overall, HGE interventions are thought to offer a benefit over PGD in some situations by providing a broader range of possible interventions, as well as by providing a larger number of suitable embryos. The latter effect is usually important in the cases where unaffected embryos are small in number, making PGD ineffective (Steffann et al., 2018 ). Whether these cases provide a reasonable ground to justify research and development on the clinical use of HGE remain potentially contentious. Some authors have suggested that the number of cases in which PGD cannot be effectively used to prevent transmission of genetic disorders is so marginal that clinical application of HGE could hardly be justified (Mertes and Pennings, 2015 ). Particularly when analyzing economic considerations (i.e., the allocation of already scarce resources towards clinical research involving expensive techniques with limited applicability) and additional risks associated with direct interventions. In either case of HGE being used as an alternative or a complementary tool to PGD, PGD will most likely still be used to identify those embryos that would manifest the disease and would hence require subsequent HGE.

The PGD technique, however, is not itself free of criticism and possible moral advantages of HGE over PGD have also been explored (Hammerstein et al., 2019 ; Ranisch, 2020 ). PGD remains ethically controversial since, identifying an unaffected embryo from the remaining embryos (which will not be used and ultimately discarded) amounts to the selection of ‘healthy’ embryos rather than ‘curing’ embryos affected by the genetic conditions. On the other hand, given a safe and effective application of the technology, the use of HGE is considered by many morally permissible to prevent the transmission of genetic variants known to be associated with serious illness or disability (de Miguel Beriain, 2020 ). One question that remains is whether HGE and PGD have a differing or equal moral permissibility or, at least, comparable. On issues including human dignity and autonomy, it was argued that HGE and PGD interventions can be considered as equally morally acceptable (Hammerstein et al., 2019 ). This equal moral status was, however, only valid if HGE is used under the conditions of existent gene variants in the human gene pool and to promote the child health’s best interest in the context of severe genetic diseases (Hammerstein et al., 2019 ). Because of selection and ‘therapy’, moral assessments resulted in HGE interventions being considered to some extent preferable to PGD, once safety is carefully assessed (Gyngell et al., 2017 ; Cavaliere, 2018 ). Specifically, PGD’s aim is selective and not ‘therapeutic’, which could be said to contradict the aims of traditional medicine (MacKellar and Bechtel, 2014 ). In contrast to PGD’s selectivity, HGE interventions are seen as ‘pre-emptively therapeutic’, and therefore closer to therapy than PGD (Cavaliere, 2018 ). However, it is also argued that HGE does not have curative aims, and thus it is not a therapeutic application, as there is no patient involved in the procedure to be cured (Rulli, 2019 ). On balance, there appears to be no consensus on which of the approaches, HGE and PGD, is morally a better strategy to prevent the transmission of single gene disorders, with a vast amount of literature expressing diverse positions when considering different scenarios (Delaney, 2011 ; Gyngell et al., 2017 ; Cavaliere, 2018 ; Ranisch, 2020 ; Rehmann-Sutter, 2018 ; Sparrow, 2021 ).

Polygenetic conditions

HGE is also argued to have the potential to be used in other disorders which have a polygenic disposition and operate in combination with environmental influences (Gyngell et al., 2017 , 2019 ). Many common diseases, which result from the involvement of several genes and environmental factors, fall into this category. Examples of common diseases of this type includes diabetes, coronary artery disease and different types of cancers, for which many of the genes involved were identified by studies of genome wide association (e.g., Wheeler and Barroso, 2011 ; Peden and Farral, 2011 ). These diseases affect the lives of millions of people globally, severely impacting health and often leading to death. Furthermore, these diseases have a considerable burden on national health systems. Currently, many of these diseases are controlled through pharmaceutical products, although making healthier life choices about diet and exercise can also contribute to preventing and managing some of them. Despite the interest, the use of PGD in polygenic conditions would hardly be feasible, due to the number of embryos needed to select the preferred genotype and available polygenic predictors (Karavani et al., 2019 ; Shulman and Bostrom, 2014 ).

In theory, HGE could be a potentially useful tool to target different genes and decrease the susceptibility to multifactorial conditions in current and future generations. The application of HGE to polygenic conditions is often argued by noting that the range of applicability of the technique (well beyond single gene disorders) would justify and outweigh the cost needed to develop it. However, to do so, a more profound knowledge of genetic interactions, of the role of genes and environmental factors in diverse processes would be needed to be able to modify such interconnected systems with limited risk to the individual (Lander, 2015 ). Besides, it is now understood that, depending on the genetic background, individuals will have different risks of developing polygenetic diseases (risk-associated variants), but hardly any certainty of it. In other words, although at the population level there would most likely be an incidence of the disease, it is not possible to be certain of the manifestation of the disease in any specific individual. As a result, the benefits of targeting a group of genes associated to a disease in a specific individual would have to be assessed in respect to the probability of incidence of the disease. The risk-benefit ratio for HGE is considerably increased for polygenic conditions compared to monogenic disorders. Additionally, the risks of adverse effects, e.g., off-target effects, increases with the number of genes targeted for editing. The latter effects make the potential benefits of HGE in polygenic diseases more uncertain than in single gene disorders.

Genetic enhancement

A widespread concern regarding the use of HGE is that such interventions could be used not only to prevent serious diseases, but also to enhance desirable genetic traits. Currently, our knowledge on how to genetically translate information into specific phenotypes is very limited and some argue that it might never be technically feasible to achieve comprehensive genetic enhancements using current gene editing technologies (Janssens, 2016 ; Ranisch, 2021 ). Similar to many diseases, in which different genetic and other factors are involved, many of the desirable traits to be targeted by any enhancement will most likely be the result of a combination of several different genes influenced by environment and context. Moreover, the implications for future generations of widespread genetic interventions in the human population and its potential impact on our evolutionary path are difficult to assess (Almeida and Diogo, 2019 ). Nevertheless, others argue that genetic enhancement through HGE could be possible in the near future (de Araujo, 2017 ).

There has been much discussion regarding the meaning of the terms and the conceptual or normative difference between ‘therapy’ and ‘enhancement’ (for an early discussion: Juengst, 1997 ; Parens, 1998 ). There are mainly three different meanings of ‘enhancement’ used in the literature. First, ‘enhancement’ is sometimes used to refer to measures that go beyond therapy or prevention of diseases, i.e., that transcend goals of medicine. Second, ‘enhancement’ is used to refer to measures that equip a human with traits or capacities that they typically do not possess. In both cases, the term points to equally controversial and contrasting concepts: on the one hand, those of ‘health’, ‘disease’ or ‘therapy’, and on the other, those of ‘normality’ or ‘naturalness’. Third, ‘enhancement’ is sometimes also used as an umbrella-term describing all measures that have a positive effect on a person’s well-being. According to this definition, the cure, or prevention of a disease is then also not opposed to an enhancement. Here again, this use refers to the controversial concept of ‘well-being’ or a ‘good life’.

It is beyond the scope of this article to provide a detailed review of the complex debate about enhancement (for an overview: Juengst and Moseley, 2019 ). However, three important remarks can be made: first, although drawing a clear line between ‘enhancement’ and ‘therapy’ (or ‘normality’, etc.) will always be controversial, some cases can be clearly seen as human enhancement. This could include modifications to augment human cognition, like having a greater memory, or increasing muscle mass to increase strength, which are not considered essential for human health (de Araujo, 2017 ).

Second, it is far from clear whether a plausible account of human enhancement would, in fact, be an objectivist account. While authors suggest that there is some objectivity regarding the conditions that constitute a serious disease (Habermas, 2003 ), the same might not be true for what constitutes an improvement of human functioning. It may rather turn out that an enhancement for some might be seen as a dis-enhancement for others. Furthermore, the use of the HGE for enhancement purposes can be considered at both an individual and a collective level (Gyngell and Douglas, 2015 ; Almeida and Diogo, 2019 ), with a range of ethical and biological implications. If HGE is to be used for human enhancement, this use will be in constant dependence on what we perceive as ‘normal’ functioning or as ‘health’. Therefore, factors such as cultural and societal norms will have an impact on where such boundaries are drawn (Almeida and Diogo, 2019 ).

Third, it should be noted that from an ethical perspective the conceptual question of what enhancement is, and what distinguishes it from therapy, is less important than whether this distinction is ethically significant in the first place. In this context, it was pointed out that liberal positions in bioethics often doubt that the distinction between therapy and enhancement could play a meaningful role in determining the limits of HGE (Agar, 1998 ). The consideration of genetic intervention for improving or adding traits considered positive by individuals have raised extreme positions. Some welcome the possibility to ameliorate the human condition, whilst others consider it an alarming attempt to erase aspects of our common human ‘nature’. More specifically, some authors consider HGE a positive step towards allowing humans the opportunity to obtain beneficial traits that otherwise would not be achievable through human reproduction, thus providing a more radical interference in human life to overcome human limitations (de Araujo, 2017 ; Sorgner, 2018 ). The advocates of this position are referred to as ‘bioliberals’ or ‘transhumanists’ (Ranisch and Sorgner, 2014 ), and its opponents are referred to as ‘bioconservatives’ (Fukuyama, 2002 ; Leon, 2003 ; Sandel, 2007 ). Transhumanism supports the possibility of humans taking control of their biology and interfering in their evolution with the use of technology. Bioconservatism defends the preservation and protection of ‘human essence’ and expresses strong concerns about the impact of advanced technologies on the human condition (Ranisch and Sorgner, 2014 ).

For the general public, HGE used in a clinical context seems to be less contentious compared when used as a possible human enhancement tool. Specifically, some surveys indicate that the general-public typically exhibits a reduced support for the use of genome editing interventions for enhancement purposes compared to therapeutic purposes (Gaskell et al., 2017 ; Scheufele et al., 2017 ). In contrast, many technologies and pharmaceutical products developed in the medical context to treat patients are already being used by individuals to ‘enhance’ some aspect of their bodies. Some examples include drugs to boost brain power, nutritional supplements, and brain-stimulating technologies to control mood, even though their efficiency and safety is not clear. This could suggest that views on enhancement may vary depending on the context and on what is perceived as an enhancement by individuals. It may be informative to carry out detailed population studies to explore whether real ethical boundaries and concerns exist, or whether these are purely the result of the way information is processed and perceived.

Heritable genome editing: Mapping the ethical debate

Even though genome editing methods have only been developed in the last decade, the normative implication of interventions into the human germline have been discussed since the second half of the 20th century (Walters et al., 2021 ). Some even argue that, virtually, all the ethical issues raised by genetic engineering were already being debated at that time (Paul, 2005 ). This includes questions about the distinction between somatic and germline interventions, as well as between therapy and enhancement (e.g., Anderson, 1985 ). Nevertheless, as it has been widely noted, it is difficult to draw clear lines between these two categories (e.g., McGee, 2020 ; Juengst, 1997 ), and alternative frameworks have been proposed, particularly in the context of HGE (Cwik, 2020 ). Other questions include the normative status of human nature (e.g., Ramsey, 1970 ), the impossibility of consent from future generations (e.g., Lappe, 1991 ), possible slippery slopes towards eugenics (e.g., Howard and Rifkin, 1977 ), or implications for justice and equality (e.g., Resnik, 1994 ).

When discussing the ethics of HGE, roughly three types of considerations can be distinguished: (i) pragmatic, (ii) sociopolitical, and iii) categorical (Richter and Bacchetta, 1998 ; cf. Carter, 2002 ). Pragmatic considerations focus on medical or technological aspects of HGE, such as the safety or efficacy of interventions, risk–benefit ratio, possible alternatives or the feasibility of responsible translational research. Such considerations largely depend on the state of science and are thus always provisional. For example, if high-risk technologies one day evolve into safe and reliable technologies, some former pragmatic considerations may become obsolete. Sociopolitical aspects, on the other hand, are concerned with the possible societal impact of technologies, e.g., how they can promote or reduce inequalities, support or undermine power asymmetries, strengthen, or threaten democracy. Similar to pragmatic considerations, sociopolitical reasons depend on specific contexts and empirical factors. However, these are in a certain sense ‘outside’ the technology—even though technologies and social realities often have a symbiotic relationship. While sociopolitical considerations can generate strong reasons against (or in favour of) implementing certain technologies, most often these concerns could be mitigated by policies or good governance. Categorical considerations are different and more akin to deontic reasons. They emphasise categorical barriers to conduct certain deeds. It could be argued, for instance, that the integrity of the human genome or the impossibility to obtain consent from future generation simply rule out certain options to modify human nature. Such categorical considerations may persist despite technological advances or changing sociopolitical conditions.

Comparing the bioethical literature on genetic engineering from the last century with the ongoing discussions shows a remarkable shift in the ethical deliberation. In the past, scholars from the field of medical ethics, as well as policy reports, used to focus on possible categorical boundaries for germline interventions and on possible sociopolitical consequences of such scenarios. For instance, the influential 1982 report “Splicing Life” from the US President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioural Research prominently discussed concerns about ‘playing God’ against the prospects of genetically engineering human beings, as well as possible adverse consequences of such interventions. Although this study addresses potential harms, pragmatic arguments played only a minor role, possibly due to the technical limitations at the time.

With the upcoming availability of effective genome editing techniques, the focus on the moral perspective seems to have been reversed. Increasingly, the analysis of the permissibility of germline interventions is confined to questions of safety and efficacy. This is demonstrated by the 2020 consensus study report produced by an international commission convened by the US National Academy of Medicine, the US National Academy of Sciences, and the UK’s Royal Society, which aimed at defining a translational pathway for HGE. Although the report recognizes that HGE interventions does not only raise pragmatic questions, ethical aspects were not explicitly addressed (National Academy of Medicine, National Academy of Sciences, and the Royal Society, 2020 ).

Similarly, in 2019, a report on germline interventions published by the German Ethics Council (an advisory body to the German government and parliament) emphasizes that the “previous categorical rejection of germline interventions” could not be maintained (Deutscher Ethikrat, 2019 , p. 5). The German Ethics Council continues to address ethical values and societal consequences of HGE. However, technical progress and the development of CRISPR/Cas9 tools seem to have changed the moral compass in the discussion about germline interventions.

For a comprehensive analysis of HGE to focus primarily on pragmatic arguments such as safety or efficacy would be inadequate. In recent years, developments in the field of genome editing have occurred at an incredibly fast pace. At the same time, there are still many uncertainties about the efficacy of the various gene editing methods and unexpected effects in embryo editing persist (Ledford, 2015 ). Social and political implication also remain largely unknown. To date, it has been virtually impossible to estimate how deliberate interventions into the human germline could shape future societies and to conduct a complete analysis of the safety aspects of germline interventions.

Moreover, as the EGE notes, we should be cautious not to limit the complex process of ethical decision-making to pragmatic aspects such as safety. The “‘safe enough’ narrative purports that it is enough for a given level of safety to be reached in order for a technology to be rolled out unhindered, and limits reflections on ethics and governance to considerations about safety” (EGE, 2021 , p. 20). Consequently, the EGE has highlighted the need to engage with value-laden concepts such as ‘humanness’, ‘naturalness’ or ‘human diversity’ when determining the conditions under which HGE could be justified. Even if a technology has a high level of safety, its application may still contradict ethical values or lead to undesirable societal consequences. Efficacy does not guarantee compatibility with well-established ethical values or cultural norms.

While concepts such as ‘safety’ or ‘risk’ are often defined in scientific terms, this does not take away the decision of what is ethically desirable given the technical possibilities. As Hurlbut and colleagues put it in the context of genome editing: “Limiting early deliberation to narrowly technical constructions of risk permits science to define the harms and benefits of interest, leaving little opportunity for publics to deliberate on which imaginations need widening, and which patterns of winning and losing must be brought into view” (Hurlbut et al., 2015 ). Therefore, if public engagement is to be taken seriously, cultural norms and values of those affected by technologies must also be considered (Klingler et al., 2022 ). This, however, means broadening the narrow focus on pragmatic reasons and allowing categorical as well as sociopolitical concerns in the discourse. Given the current attention on pragmatic reasons in current debates on HGE, it is therefore beneficial to revisit the categorical and sociopolitical concerns that remain unresolved. The following sections provide an overview of relevant considerations that can arise in the context of HGE and that underline many of the societal concerns and values crucial for public engagement.

Human genome ‘integrity’

Heritability seems to be one of the foremost considerations regarding germline genome editing, as it raises relevant questions on a ‘natural’ human genome and its role in ‘human nature’ (Bayertz, 2003 ). This follows an ongoing philosophical debate on ‘human nature’, at least as defined by the human genome. This has ensued a long debate on the value of the human genome and normative implications associated with its modification (e.g., Habermas, 2003 ). Although a comprehensive discussion of these topics goes beyond the scope of this paper, the human genome is viewed by many as playing an important role in defining ‘human nature’ and providing a basis for the unity of the human species (for discussion: Primc, 2019 ). Considering the implications for the individual and the collective, some affirm the right of all humans to inherit an unmodified human genome. For some authors, germline modification is considered unethical, e.g., a “line that should not be crossed” (Collins, 2015 ) or a “crime against humanity” (Annas et al., 2002 ).

The Universal Declaration on the Human Genome and Human Rights (UDHGHR) states that “the human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity” (Article 1, UNESCO, 1997 ). The human genome is viewed as our uniquely human collective ‘heritage’ that needs to be preserved and protected. Critics of heritable genetic interventions argue that germline manipulation would disrupt this natural heritage and therefore would threaten human rights and human equality (Annas, 2005 ). Heritable human genome editing creates changes that can be heritable to future generations. For many, this can represent a threat to the unity and identity of the human species, as these modifications could have an impact on the human’s gene pool. Any alterations would then affect the evolutionary trajectory of the human species and, thus, its unity and identity.

However, the view of the human genome as a common heritage is confronted with observations of the intrinsic dynamism of the genome (Scally, 2016 ). Preservation of the human genome, at least in its current form, would imply that the genome is static. However, the human genome is dynamic and, at least in specific periods of environmental pressure, must have naturally undergone change, as illustrated by human evolution (Fu and Akey, 2013 ). The genome of any individual includes mutations that have occurred naturally. Most of them seem to be neither beneficial nor detrimental to the ability of an individual to live or to his/her health. Others can be detrimental and limiting to their wellbeing. It has been shown that, on average, each human genome has 60 new mutations compared to their parents (Conrad et al., 2011 ). At the human population level, a human genome can have in average 4.1–5 million variants compared to the ‘reference’ genome (Li and Sadler, 1991 ; Genomes Project C, 2015 ). The reference genome itself is thus a statistical entity, representing the statistic distribution of the probability of different gene variants in the whole genome. Human genomic variation is at the basis of the differences in the various physical traits present in humans (e.g., eye colour, height, etc.), as well as specific genetic diseases. Thus, the human population is comprised of genomes with a pattern of variants and not of ‘one’ human genome that needs to be preserved (Venter et al. 2001 ). The human genome has naturally been undergoing changes throughout human history. An essentialist view of nature seems to be the basis for calling for the preservation of genome integrity. However, in many ways, this view is intrinsically challenged by the interpretation portrayed by evolutionary biology of our genetic history already more than a century ago. Nevertheless, despite the dynamic state of the human genome, this in itself cannot justify the possibility of modifying the human genome. It is also worth considering that the integrity of the human genome could also be perceived in a ‘symbolic’ rather than biological literal meaning. Such an interpretation would not require a literally static genome over time, but instead suggest a boundary between ‘naturally’ occurring variation and ‘artificially’ induced change. This is rather a version of the ‘natural’/unnatural argument, rather than an argument for a literally unchanged genetic sequence.

The modification of the human genome raises complex questions about the characterization of the human species genome and if there should be limits on interfering with it. The options to modify the human genome could range from modifying only the genes that are part of the human gene pool (e.g., those genes involved in severe genetic diseases such as Huntington’s disease) to adding new variants to the human genome. Regarding variants which are part of the common range of variation found in the human population (although it is not possible to know all the existent variations), the question becomes whether HGE could also be used in any of them (e.g., even the ones providing some form of enhancement) or only in disease-associated variants and thus be restricted to the prevention of severe genetic diseases. In both cases, the integrity of the human genome is expected to be maintained with no disruption to human lineage. However, it could be argued that this type of modification is defending a somewhat conservative human nature argument, since it is considering that a particular genetic make-up is ‘safe’ or would not involve any relevant trade-offs. In contrast, a different conclusion could be drawn on the integrity of the human genome when introducing genotypical and phenotypical traits that do not lie within the common range of variation found in the population (Cwik, 2020 ). In all cases, since the implications of the technology are intergenerational and consequently, it will be important to carry out an assessment of the risks that we, as a species, are willing to take when dealing with disease and promoting health. For this, we will need to explore societal views, values and cultural norms associated with the human genome, as well as possibly existing perceptions of technology tampering with ‘nature’. To support such an assessment, it would be useful to draw on a firm concept of human nature and the values it implies, beyond what is implied by genetic aspects.

Human dignity

In several of the legally binding and non-binding documents addressing human rights in the biomedical field, human dignity is one of the key values emphasized. There are concerns that heritable genome interventions might conflict with the value of human dignity (Calo, 2012 ; Melillo, 2017 ). The concerns are considered in the context of preserving the human genome (Nordberg et al. 2020 ). More specifically, the recommendation on Genetic Engineering by the Council of Europe (1982) states that “ the rights to life and to human dignity protected by Articles 2 and 3 of the European Convention on Human Rights imply the right to inherit a genetic pattern which has not been artificially changed” (Assembly, 1982 ). This is supported by the Oviedo Convention on Human Rights and Biomedicine (1997), where Article 13 prohibits any genetic intervention with the aim of introducing a modification in the genome of any descendants. The Convention is the only international legally binding instrument that covers human germline modifications among the countries which have ratified it (Council of Europe, 1997 ). However, there have been some authors disputing the continued ban proposed by the Oviedo Convention (Nordberg et al. 2020 ). Such authors have focused on the improvements of safety and efficacy of the technology in contrast to authors focusing on its value for human dignity (Baylis and Ikemoto, 2017 ; Sykora and Caplan, 2017 ). The latter authors seem to highlight the concept of human dignity to challenge heritable interventions to the human genome.

But a question in debate has been to demonstrate how ‘human dignity’, described in such norms, relates to heritable genome interventions. The concept of the human genome as common genetic heritage, distinguishing humans from other species seems one of the main principles implied by such norms. In this view, the human genome determines who belongs to the human species and who does not, and thus confers an individual the dignity of being a human by association. This creates an inherent and strong link between the concept of human genome and the concept of human dignity and its associated legal rights (Annas, 2005 ). It could be argued that a genetic modification to an individual may make it difficult for him/her to be recognized as a human being and therefore, preservation of the human genome being important for human dignity to be maintained. This simple approach, or at least interpretation, however, ignores the fact that the human genome is not a fixed or immutable entity, as exemplified by human evolution (as discussed in the previous section). As a result, the view that HGE interventions are inherently inadmissible based on the need to preserve human dignity is contested (Beriain, 2018 ; Raposo, 2019 ). More broadly, the idea that biological traits are the basis for equality and dignity, supporting the need for the human genome to be preserved, is often challenged (Fenton, 2008 ).

It is argued that to fully assess the impact of the HGE interventions on human dignity, it will be necessary to have a better understanding of the concept of human dignity in the first place (Häyry, 2003 ; Cutas, 2005 ). For some, however, human dignity is a value that underlies questions of equality and justice. Thus, the dignity-based arguments could uncover relevant questions in the discussion of ethical implications on modifying the human genome (Segers and Mertes, 2020 ). In the Nuffield Council on Bioethics Report (2018) principles of social justice and solidarity, as well as welfare, are used to guide the debate on managing HGE interventions. Similarly, the concept of human dignity could, therefore, provide the platform upon which consideration of specific values could be discussed, broaden the debate on HGE to values shared by society.

Right of the child: informed consent

In many modern societies, every individual, including children, have the rights to autonomy and self-determination. Therefore, each person is entitled to decide for themselves in decisions relating to their body. These rights are important for protecting the physical integrity of a person. When assessing the implication of allowing individuals to take (informed) decisions relative to the use of heritable genetic interventions on someone else’s body, it is useful to reflect on the maturity of existing medical practices and, more broadly, on the additional complexities associated with the heritability of any such intervention.

In modern health-care systems, informed consent provides the opportunity for an individual to exercise autonomy and make an informed decision about a medical procedure, based on their understanding of the benefits and risks of such procedure. Informed consent is thus a fundamental principle in medical (research) ethics when dealing with human subjects (Beauchamp and Childress, 2019 ).

Heritable genome interventions present an ethical constraint on the impossibility of future generations of providing consent to an intervention on their genome (Smolenski, 2015 ). In other words, future generations cannot be involved in a decision which could limit their autonomy, since medical or health-related decisions affecting them are placed on the present generation (and, in the case of a child to be born, more specifically, on his/her parents). However, many other actions taken by parents of young children also intentionally influence the lives of those children and have been doing so for millennia (Ranisch, 2017 ). Although these actions may not involve altering their genes, many of such actions can have a long-lasting impact on a child’s life (e.g., education and diet). However, it could be argued that they do not have the irreversible effect that HGE will have in the child and future generations. In cases where parents act to expand the life choices of their children by eliminating disease (e.g., severe genetic diseases), this would normally be thought to outweigh any possible restriction on autonomy. In these cases, if assuming HGE benefits will outweigh risks regarding safety and efficacy, the use of HGE could be expected to contribute to the autonomy of the child, as him/her would be able in the future to have a better life, not constrained by the limitations of the disease. As a result, even if it is accepted that these technologies may in one way reduce the autonomy of future generations, some believe that this will often be outweighed by other effects increasing autonomy (Gyngell et al., 2017 ). In other words, it is reasonable to suppose that, when taken by parents based on good information and understanding of risks and impacts, the limitation in the autonomy of unborn children associated with heritable genetic interventions would be compensated by the beneficial effects of increasing their autonomy when born (Gyngell et al., 2017 ).

It has often been emphasized that possible genetic interventions must not curtail the future possibilities of offspring to live their lives according to their own idea of a good life. This view originated in the liberal tradition and is associated with the “right to an open future”, defended by Joel Feinberg ( 1992 ). That is an anticipatory autonomy right that parents can violate, even though the offspring could exercise it only in the future. Feinberg has discussed the right to an open future in the context of religious education. However, various authors have applied this argument to the question of permissible and desirable genetic interventions (Buchanan et al., 2000 ; Glover, 2006 ; Agar, 1998 ). Accordingly, germline modifications or selection would have to allow the offspring to have a self-determined choice of life plans. It would therefore be necessary to provide offspring with genetic endowments that represent the so-called all-purpose goods. These goods are “useful and valuable in carrying out nearly any plan of life or set of aims that humans typically have” (Buchanan et al., 2000 , p. 167). While this claim is certainly appealing, in reality it will be difficult to identify phenotypes that will only broaden and do not narrow the spectrum of life plans. Take, for example, body size: a physique favourable for a basketball player would at the same time be less favourable in successfully riding horses as a professional jockey and vice versa. Increasing some opportunities often means reducing other ones.

The arguments of informed consent and open future need to be explored outside the realm of severe genetic diseases by considering other scenarios (including scenarios of genetic enhancement). Hereby, the effects of the interventions on the autonomy of future generations can be assessed more comprehensively. As for enhancement, decisions outside the realm of health can be more controversial, as the traits that parents see fit to generate enhancement may inadvertently condition a child’s choices in the future in an undesirable way.

If HGE is to be used, questions on how the consent and information should be provided to parents to fully equip them to decide in the best interests of the child will need to be assessed (Evitt et al., 2015 ). This is evident if considering the informed consent used in the study conducted by He Jiankui. One of the many criticisms of the study was the inadequacy of the informed consent process provided to the parents, which did not meet regulatory or ethical standards (Krimsky, 2019 ; Kirksey, 2020 ). This raises questions on how best to achieve ethical and regulatory compliance regarding informed consent in applications of HGE (Jonlin, 2020 ).

Discrimination of people with disabilities

For many years, there has been an effort to develop selective reproduction technologies to prevent genetic diseases or conditions leading to severe disabilities. These forms of reproductive genetic disease prevention are based on effectively filtering and eradicating embryos or foetuses affected by genetic diseases. There are divergent views regarding the use of these technologies. For example, the disability rights movement argues that the use of technologies such as prenatal testing (PNT) and PGD discriminates against people living with a disability (Scully, 2008 ; Asch and Barlevy, 2012 ). The key arguments presented supporting this view are: (i) the limited value of a genetic trait in respect to the life of an embryo (Parens and Asch, 2000 ) and (ii) the ‘expressivist’ argument (Buchanan, 1996 ; Shakespeare, 2006 ). The first argument is based on the critique that a disabling trait is viewed as being more significant than the life of an embryo/foetus. This argument was initially used in the context of prenatal testing and selective termination, and has also been applied in the context of new technologies like PGD (Parens and Asch, 2000 ). The second, the ‘expressivist’ argument, argues that the use of these technologies expresses negative or discriminatory views on the disabling conditions they are targeting and subsequently on the people living with these conditions (Asch and Wasserman, 2015 ). The expressivist argument, however, has been challenged by stressing the importance of differentiating between the disability itself and the people living with disability (Savulescu, 2001 ). The technology’s use is aimed at reducing the incidence of disability, and it does not have a position of value on the people that have a specific condition.

When applying the same arguments to the use of HGE in comparison with other forms of preventing heritable genetic diseases, some important considerations can be made. Regarding the first argument, in contrast to selective reproduction technologies, HGE may allow the removal of the disabled trait with the aim of ensuring survival of the affected embryo. However, most likely, PGD would be used before and after the editing of the embryos to help the identification of the ones requiring intervention and verifying the efficiency of the genetic intervention (de Miguel Beriain, 2018 ; Ranisch, 2020 ). Similarly, the expressivist argument continues to be challenged if the application of human HGE is envisaged in the context of severe genetic diseases (e.g., Tay-Sachs and Huntington’s disease). It has been argued that the choice to live without a specific genotype neither implies discriminating people living with a respective condition nor considering the life of people living with the disease not worth living or less valuable (Savulescu, 2001 ). In other words, the expressivist argument is not a valid or a sufficiently strong ethical argument for prospective parents not to have the option to have a future child without a genetic disease.

It is worth noting that the debate on the use of reproduction technologies for the prevention of genetic diseases is not at all new, and that modern HGE techniques only serve to highlight ethical concerns that have been expressed for a long time. In the case of preventing genetic diseases, the application of both arguments to HGE intervention could be considered not to provide sufficiently strong ethical arguments to limit the use of the technology in the future. However, it is worth exploring whether scientific innovations like HGE are either ameliorating or reinvigorating ethical concerns expressed so far, for example in creating a future that respects or devalues disability as a part of the human condition. Perhaps even more importantly, given their potential spectrum of possible intervention and efficacy, it is important to reflect on whether the broad use of HGE could have an impact on concepts of disability and ‘normality’ as a whole distorting an already unclear ethical line between clinical and non-clinical interventions. Moreover, research work exploring the relationship between disability and identity indicated that personhood with disability can be an important component to people’s identity and interaction with the world. In the case of heritable human genome editing, it is not yet known how this technology will impact the notions of identity and personhood in people who had their germline genome modified (Boardman and Hale, 2018 ). For further progress on these issues public engagement might be important to gather different views and perceptions on the issue.

Justice and equality

Beside the limits of applicability, another common ethical concern associated with the use of genome editing technologies, as with many new technologies, is the question of accessibility (Baumann, 2016 ). Due to the large investments that will need to be made for continuing development of the technology, there is a (perceived) risk of it becoming an expensive technology that only a few wealthy individuals in any population (and/or only citizens in comparatively rich countries) can access. In addition, there is concern that patenting of genome editing technologies will delay widespread access or lead to unequal distribution of corresponding benefits (Feeney et al., 2018 ). This may, consequently, contribute to further increases in existing disparities, since individuals or countries with the means of accessing better health treatments may have economic advantages (Bosley et al., 2015 ). This could enhance inequality at different levels, depending on the limits of applicability of the technology. Taken to its extreme, the use of the technology could allow germline editing to create and distinguish classes of individuals that could be defined by the quality of their manipulated genome.

The concern that the possibility of germline interventions in humans could entrench or even increase inequalities has accompanied the discussion about ethics of genetic interventions from the very beginning until today (e.g. Resnik, 1994 ). In ‘Remaking Eden’ Lee Silver envisioned a divided future society, consisting of a genetically enhanced class, the “genRich”, and a genetic underclass, the “naturals” (Silver, 1997 ). Françoise Baylis recently echoed such concerns regarding future HGE interventions, namely that “unequal access to genome-editing technologies will both accentuate the vagaries of the natural lottery and introduce an unjust genetic divide that mirrors the current unjust economic and social divide between rich and poor individuals” (Baylis, 2019 , p. 67). At the same time, the possibility to genetically intervene in the ‘natural lottery’ has also been associated with the hope of countering natural inequalities and increase equality of opportunities. Robert Sinsheimer may be among the first to envision such a ‘new’ individualistic type of ‘eugenics’ that “would permit in principle the conversion of all of the unfit to the highest genetic level” (Sinsheimer, 1969 , p. 13). More recently, in the book ‘From chance to choice: Genetics and justice’ (2000) it is argued that “equality of opportunity will sometimes require genetic interventions and that the required interventions may not always be limited to the cure or prevention of disease” (Buchanan et al., 2000 , p. 102). When discussing issues related to justice and equality, it will be important to involve a broad spectrum of stakeholders to better evaluate the economic effects of the commercialization of the technology.

Conclusions

With ongoing technological developments and progress with guiding and regulating its acceptable use, the possibility of HGE interventions in the human genome is closer than ever to becoming a reality. The range of HGE applicability can go from preventing the transmission of genetic variants associated with severe genetic conditions (mostly single gene disorders but also, to a lesser extent, polygenic diseases) to genetic enhancements. The permissibility of HGE has often been considered on the basis of possible uses, with therapeutic uses generally considered more acceptable than non-therapeutic ones (including human enhancement). When compared with other technologies with similar therapeutic uses (e.g., PGD) already in use, HGE presents similarities and differences. However, from an ethical acceptability perspective, there is currently no consensus on whether HGE is more or less acceptable than PGD.

An important conclusion of this study is that, along with the technological development of genome germline editing techniques, a shift in the focus of analyses on its applicability has been observed. More specifically, the emphasis on pragmatic considerations seems to have increased substantially compared with the previous emphasis on categorical and sociopolitical arguments. Many of the most recent publications from authoritative advisory committees and institutions discuss the permissibility of HGE interventions primarily on the basis of pragmatic arguments, in which safety and efficacy are the main focus. Since germline interventions could profoundly change the human condition, the need for a broad and inclusive public debate on this topic has also been frequently emphasized. However, limited consideration has been given to approaches to carry out such action effectively, and on how to consider their outcomes in relevant policies and regulations.

It is currently not entirely clear whether: (i) the pragmatic position championed by such authoritative sources builds on the premise that the ethical debate has reached sufficient maturity to allow a turning point; (ii) the lack of progress has somewhat hampered further consideration of issues still considered controversial; (iii) regulatory pressure is somewhat de facto pushing forward the introduction of such technologies despite critical, unresolved ethical issues. Based on the analysis presented in this paper, a combination of the latter factors (ii and iii) seems more likely. In engaging the public in societal debates on the acceptability of such technologies, unresolved questions are likely to re-emerge. Specifically, it is possible that categorical and sociopolitical considerations will gain renewed focus during public engagement. In other words, when involving the public in discussions on HGE, it is possible that cultural values and norms, not only questions of safety and efficacy, will re-emerge as crucial to the acceptance of the technology (What is meant by natural? What is understood by humanity? etc.).

HGE interventions put into question specific biological and moral views of individuals, including views on the value of the human genome, on human dignity, on informed consent, on disability and on societal equality and justice. The range of ethical issues affected by the introduction of such technology, often still characterised by non-convergent, and at times conflicting, positions, illustrate the importance of further consideration of these issues in future studies and public engagement activities. As a result, society’s moral uncertainties will need to be assessed further to support the regulation of HGE technologies and form a well-informed and holistic view on how they can serve society’s common goals and values.

Data availability

This statement is not applicable.

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This work was supported by Fundação para Ciência e a Tecnologia (FCT) of Portugal [UIDP/00678/2020 to M.A]. We thank Dr. Michael Morrison for his comments and Dr. Gustav Preller for his proofreading of this manuscript.

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Almeida, M., Ranisch, R. Beyond safety: mapping the ethical debate on heritable genome editing interventions. Humanit Soc Sci Commun 9 , 139 (2022). https://doi.org/10.1057/s41599-022-01147-y

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Chapter 6: Public Opinion About Food

The Pew Research survey included a handful of questions related to genetically modified (GM) foods and one on the safety of foods grown with pesticides. This chapter looks at each of these in turn. The findings point to a mix of factors that are central to the public’s beliefs about food safety. Women and blacks appear to be more leery of GM foods and pesticides on crops. And there are sizeable differences across education and knowledge groups in thinking about these foods. Additionally, the public tends to be skeptical that scientists, on the whole, have a clear understanding of the health effects of GM crops

Genetically Modified Foods

A minority of adults (37%) say that eating GM foods is generally safe, while 57% say they believe it is unsafe. And, most are skeptical about the scientific understanding of the effects of genetically modified organisms (GMOs) on health. About two-thirds (67%) of adults say scientists do not clearly understand the health effects of GM crops; 28% say scientists have a clear understanding of this.

Information about eating GM products is sometimes provided voluntarily by food producers. About half of U.S. adults report that they always (25%) or sometimes (25%) look to see if products are genetically modified when they are food shopping. Some 31% say they never look for such labels and 17% say they do not often look.

Gender, Age, Race and Ethnicity

Fewer women (28%) than men (47%) believe eating GM foods is safe. Opinions also tend to vary by race and ethnicity with fewer blacks (24%) and Hispanics (32%) than whites (41%) saying that GM foods are safe to eat. Views about GMOs are roughly the same among both younger (ages 18 to 49) and older (50 and older) adults.

Education and Knowledge

Views about the safety of GM foods differ by education. Those who hold a college degree, especially those with a postgraduate degree, are more likely than those with less education to say GM foods are safe.

Those with postgraduate degree say that GM foods are generally safe or unsafe by a margin of 57% to 38%. This is the only education group with a majority saying such foods are generally safe.

Those with more knowledge about science in general are closely divided about the safety of eating GM foods (48% safe to 47% unsafe). Those with less knowledge about science are more likely to see GM foods as unsafe to eat (26% safe to 66% unsafe).

There are no differences between those with a college degree in a scientific field and those with a degree in some other field on this issue.

Party and Ideology

There are no statistically significant differences on the safety of eating GM foods between Republicans and those who lean to the Republican Party as compared with Democrats and those who lean to the Democratic Party. Nor are there differences on this issue among political or ideological groups.

Multivariate Analyses

A multivariate logistic regression predicting the view that GM foods are generally safe finds a number of significant predictors. Belief that scientists have a clear understanding of the health effects of GM foods is a significant predictor of views about GM food safety (+0.24). 45

Those with a postgraduate degree are more likely to say such foods are safe, relative to those with a high school degree or less schooling, holding other factors at their means (+0.18). A person with more science knowledge is 17 percentage points more likely to say that GM foods are safe. Adults with less science knowledge and a high school degree or less have a predicted probability of 0.30 of saying genetically modified foods are safe to eat, while adults with a postgraduate degree and more science knowledge have a predicted probability of 0.65.

The predicted probability of a man saying that GM foods are safe to eat was 0.50 (50%) while that of a woman saying such foods are safe was 0.32 (32%) – a difference of 18 percentage points. African Americans are more likely than whites to say that eating GM foods is unsafe (a difference of 14 percentage points).

Holding other factors at their means, those with no party affiliation or leaning are 21 percentage points less likely than are Democrats and leaning Democrats to say that GM foods are safe. There is no significant difference between Republicans and independents that lean to the GOP and their Democratic counterparts, however. Nor is political ideology a significant predictor of views about the safety of GM foods.

A separate model that includes a factor for the judgment that the overall effect of science on the quality of food in the U.S. was either mostly positive or mostly negative also was a significant predictor of views about GM foods. Those with a positive view of science’s effect on food quality were more likely to consider GM foods safe to eat. The other factors shown above were significant in both models. (Further details about this model are available upon request.)

Looking for GM Food Labels While Shopping

The Pew Research survey also asked respondents how often they pay attention to whether products are labeled as genetically modified when food shopping. Some 25% of adults say they always look for such labels; 25% say they do so sometimes, while 17% say they do so “not too often.” Three-in-ten (31%) say they never look for GM labeling.

In general, those who consider GM foods unsafe check for GM food labels more often: 35% of this group always looks to see if products are genetically modified, compared with 9% among those who consider such foods generally safe to eat.

Consistent with gender differences in the perceived safety of eating GM foods, men and women also differ in their reported shopping behavior. Women are more likely to say they look for GM labels at least sometimes while men are more likely to say they never do so.

Blacks are more likely than either whites or Hispanics to say they always look for GM labels while shopping. Differences by age tend to be modest. Fewer seniors report “always” looking for GM labels. There are no differences among other age groups in self-reported attention to GM food labels.

There are no significant differences by education or science knowledge in self-reported attention to GM labeling.

Party and political ideology groups are about equally likely to report looking for GM labels when food shopping.

An ordered logistic regression analysis shows that women (relative to men) and African Americans (relative to non-Hispanic whites) report looking for GM food labels more frequently. The average change in predicted probability between never and always looking for food labels among women is 6 percentage points; the average change among African Americans is 7 percentage points. None of the other factors in the model were significant predictors of attention to GM labels.

A separate model (not shown) found that beliefs about whether scientists have a clear understanding about the health effects of GM crops to be a significant predictor of more frequent attention to GM labeling. Gender and race have an independent effect, however, even when controlling for views of scientific understanding about GM crops. (Details are available upon request.)

Perceptions of Scientific Understanding About GM Crops

Survey respondents were asked: “From what you’ve heard or read, would you say scientists have a clear understanding of the health effects of genetically modified crops or are scientists not clear about this?”

Two-thirds (67%) of adults say scientists do not have a clear understanding, while 28% say scientists have a clear understanding of the health effects.

Not surprisingly, people’s views about scientific understanding of GMOs are significantly related to their views about the safety of eating GM foods and to their own reports of seeking out GM food labels when grocery shopping.

A majority of men and women, whites, blacks and Hispanics, and of all age groups, say scientists do not have a clear understanding of the health effects of GM crops.

Consistent with gender differences about the safety of eating GM foods, women are less inclined than men to say that scientists have a clear understanding about this.

Older adults are more inclined than younger adults to say scientists do not have a clear understanding about the health effects of GM crops.

Non-Hispanic whites and blacks are more likely than Hispanics to say scientists do not have a clear understanding of this.

While those with a postgraduate degree are particularly likely to say that eating GM foods is generally safe, a majority of all education groups, including those with a postgraduate degree, believe scientists do not have a clear understanding of the health effects of GM crops. Nor are there differences in views on this point between those with more and less knowledge about science or those with a college degree in a science field as compared with those with degrees in other fields.

Similarly, there are no differences among party and ideological groups about scientific understanding of health effects from GM crops.

A multivariate logistic regression model predicting the view that scientists have a clear understanding of the health effects of GM crops finds older adults inclined to hold a skeptical view about scientific understanding of GMOs. On average, the oldest adults are 25 percentage points less likely than the youngest adults to say scientists have a clear understanding about this issue, controlling for other factors. Women (-0.06) are more likely than men to hold a skeptical view about scientific understanding of GMOs. Hispanics (+0.10) are more likely than are whites to say that scientists have a clear understanding about these issues.

Safety of Foods Grown with Pesticides

Most Americans are skeptical that eating foods grown with pesticides are safe for consumption. About seven-in-ten (69%) adults say that eating such foods is generally unsafe , while 28% say it is safe.

The patterns of opinion on this issue are similar to those on the safety of eating genetically modified foods. Women are less likely than men to consider it safe to eat foods grown with pesticides, though a majority of both groups considers eating foods grown with pesticides unsafe.

Blacks and Hispanics are a bit more likely than whites to consider eating such foods unsafe. Majorities of all three racial and ethnic groups say that eating foods grown with pesticides is generally unsafe.

Adults ages 18 to 49 hold about the same views as those ages 50 and older on this issue. Adults under age 30 are a bit more likely than those 65 and older to say that eating foods grown with pesticides is generally unsafe (75% to 64%). Majorities of all age groups consider eating such foods to be generally unsafe.

Those holding at least a college degree are more likely than those with less schooling to say that foods grown with pesticides are safe to eat. And those who earned a degree in a scientific field are more likely than other college graduates to consider foods grown with pesticides safe. Similarly, those with more knowledge about science, generally, are more inclined to see such foods as safe to eat. However, majorities of all education and knowledge groups say it is generally unsafe to eat foods grown with pesticides.

Republicans and independents who lean Republican are more likely than their Democratic counterparts to say it is safe to eat foods grown with pesticides (39% vs. 23%), although majorities of both groups say that eating such foods is generally unsafe. There are no differences by ideological groups on this issue.

A multivariate logistic regression analysis finds women (-0.16) and African Americans (-0.13) less likely to consider foods grown with pesticides to be safe for consumption, compared to men or whites, respectively. Those who know more about science are more likely to say such foods are safe (+0.14), although education, per se, is not an independent predictor of views about this issue.

Republicans and leaning Republicans are 13 percentage points more likely than Democrats and leaning Democrats to say eating foods grown with pesticides are safe, with other characteristics statistically controlled. The relative influence of party in predicting views on this issue is on par with that of other factors. There is no significant effect of ideology.

A separate model, not shown, which includes judgment that the overall effect of science on the quality of food in the U.S. was mostly positive or negative, was also a significant predictor of views about this. Those with a positive view of science’s effect on food quality were more likely to consider foods grown with pesticides to be safe. The other factors shown above were significant in both models. (Details are available upon request.)

• We also ran these analyses without including beliefs that scientists have a clear understanding of the health effects of GM foods to test that the findings shown here hold regardless of this difference in model specification. Details are available upon request. ↩

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Genetically modified organisms: tricks or threats

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Thanks to recent advances in synthetic biology, the interest in genetically modified organisms (GMOs) is exponentially increasing and their applications for real life appear virtually endless, ranging from the manufacture of drugs and vaccine to their use in the agro-food field. ...

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Debunking the 9 Most Common Myths About GMOs

By dispelling common misconceptions, a more constructive discussion can be had about the health benefits of gmos..

• Alivia Kaylor, MSc

Misconceptions about genetically modified organisms (GMOs) have formed due to factors such as limited understanding of the science behind genetic engineering, fear of unknown consequences, media portrayal that focuses on controversies and risks, the spread of misinformation through social media outlets, and visceral emotional responses related to health, environment, ethics, and cultural values.

These factors have contributed to the development and perpetuation of misconceptions despite scientific consensus supporting genetic modification's safety and potential benefits. In the scientific community, there is little dispute or controversy regarding the safety of these crops.

While roughly 90% of scientists, including the American Medical Association (AMA), the National Academy of Sciences, the American Association for the Advancement of Science, and the World Health Organization (WHO), hold the belief that GMOs are safe , only slightly over one-third of consumers share this perspective.

What Are GMOs?

Genetic engineering involves transferring specific DNA from one organism to another — altering the DNA of organisms and creating GMOs . While genetically modified animals are primarily used for research, genetically modified plants have become prevalent in the global food system.

In 1994, there was a significant transformation in the agricultural landscape of the United States as the US Food and Drug Administration (FDA) approved the first commercially cultivated GMO to be grown on American farmland.

Regulatory agencies such as the US Department of Agriculture (USDA), Environmental Protection Agency (EPA), and FDA collaborate to ensure the safety of GMO crops for humans, animals, and the environment. Their collective efforts focus on evaluating and approving the safety of genetically engineered crops.

The EPA specifically oversees the safety of plant-incorporated protectants (PIPs), substances within GMO plants that function as pesticides. These PIPs often confer resistance to insects or diseases. Additionally, the EPA regulates the safety of other pesticides used on both GMO and non-GMO crops.

“To some degree, everything is genetically modified,” said Erma Levy, MPH, RD, LD, a research dietitian at the University of Texas MD Anderson Cancer Center, in an MD Anderson article.

Despite being extensively used in diverse industries like healthcare, pharmaceuticals, and life sciences, numerous prevailing myths are associated with GMOs. Here are the top misconceptions related to GMOs in these sectors:

Myth: GMOs Are Unsafe for Human Consumption.

Fact : Scientific studies and regulatory agencies worldwide have consistently affirmed the safety of GMOs for human consumption. In a comprehensive report published in 2016, the National Academies of Science, Engineering, and Medicine stated that GMOs are no more risky than conventionally bred crops.

Additionally, the European Food Safety Authority reviewed over 1,000 scientific studies in 2020 and concluded that GMOs pose no higher risk to human health than their non-GMO counterparts.

These findings align with the consensus reached by reputable organizations, such as the WHO and AMA, asserting safety.

As of January 2022, more than 3,000 scientific studies have assessed the safety of crops in terms of human health and environmental impact. Overall, the weight of scientific evidence supports the conclusion that GMOs are safe for human consumption.

Myth: GMOs Cause Allergic Reactions.

Fact : Scientific research has consistently demonstrated that GMOs do not pose a significant risk of causing allergic reactions. GMOs are rigorously assessed, including evaluating potential allergenicity.

Food allergies primarily stem from allergens in a limited set of nine foods — peanuts, tree nuts, milk, eggs, wheat, soy, shellfish, sesame, and fish. To illustrate, soy, an allergenic food, can be found in GMOs. According to the FDA , if a person is allergic to traditional (non-GMO) soy-based products, they would also be allergic to GMO soy-based foods. Conversely, without an allergy to conventional soy-based foods, people do not exhibit an allergic reaction to GMO soy-based foods.

Scientists who develop GMOs conduct thorough testing to ensure that allergens are not transferred from one food to another. Extensive research indicates that GMO foods are no more likely to provoke allergies compared to non-GMOs.

For instance, a 2020 Foods study examined the allergenicity of genetically modified soybeans. Researchers concluded that genetically modified soybeans were just as safe as non-GM soybeans, with no increased allergenic potential found. These findings and numerous other studies provide a solid scientific foundation for dispelling concerns about GMOs causing allergic reactions.

Myth: GMOs Cause Cancer.

Fact : Multiple scientific studies and regulatory assessments have consistently shown that GMOs are not linked to increased cancer risks.

Agencies such as the National Academies of Science, Engineering, and Medicine , WHO , and the European Food Safety Authority (EFSA) have all affirmed the safety of GMOs and found no evidence linking them to cancer. The Cancer Council has also declared no proven evidence of a link between genetically modified foods on the market and cancer risk.

These recent and reputable references provide robust scientific evidence to dispel the unfounded claim that GMOs cause cancer.

Myth: GMOs Are Not Well-Regulated.

Fact : Scientific evidence has consistently demonstrated the effective regulation of GMOs.

Regulatory agencies such as the EPA, FDA, and USDA collaborate closely to ensure the safety of GMO crops for humans, animals, and the environment. Their collective efforts focus on evaluating and approving the safety of genetically engineered crops.

A PLOS ONE study analyzed the environmental impacts of genetically modified crops and found that, on average, these crops reduced pesticide use by 37% and increased crop yields by 22%. The study also highlighted the strict regulatory frameworks in place, emphasizing the rigorous evaluation of GMOs before their approval for commercial cultivation.

Another study reviewed over 1,700 scientific publications and concluded that GMOs are no riskier than their conventional counterparts. These findings, combined with the extensive regulatory oversight by government agencies, provide substantial evidence supporting the well-regulated nature of GMOs.

Myth: GMOs Threaten Biodiversity.

Fact : Genetic modification techniques allow for precise changes in specific genes and traits, which can contribute to biodiversity preservation by enhancing crop resilience and reducing the need for harmful pesticides.

Scientific research conducted in recent years proves that GMOs do not significantly threaten biodiversity.

In a 2014 publication , researchers conducted a meta-analysis to evaluate the influence of genetically modified crops on biodiversity. By examining data from 147 original studies, they concluded that utilizing genetically modified crops did not result in significant detrimental effects on the diversity of plant and animal populations.

Research indicates that GMOs can affect ecosystems differently depending on the traits introduced. For example, insect-resistant GMOs may reduce the need for chemical insecticides, potentially benefiting non-target organisms. However, it acknowledges the importance of monitoring and assessing long-term effects to preserve biodiversity and ecosystem stability.

Myth: GMOs Are Designed for Corporate Benefit and Agribusiness.

Fact : Genetic engineering offers a variety of benefits , including more nutritious and flavorful food, disease- and drought-resistant plants requiring fewer resources, reduced pesticide use, increased food supply with lower costs and longer shelf life, faster growth of plants and animals, food with desirable traits (e.g., lower cancer-causing substances in fried potatoes), and the potential for medicinal foods serving as vaccines or medicines.

According to the FDA , the primary purpose behind developing most GMO crops grown today is to assist farmers in mitigating crop loss. The three prevailing traits frequently found in GMO crops include the following:

• Insect resistance
• Herbicide tolerance
• Virus resistance

Recent scientific findings also demonstrate that GMOs can offer substantial benefits beyond the interests of corporations and agribusiness, positively impacting farmers, productivity, and sustainability.

Myth: GMOs Are Linked to Pollinator Decline.

Fact : Scientific research has consistently shown that GMOs are not responsible for the decline in pollinator species.

A meta-analysis examined the potential effects of Bacillus thuringiensis (Bt) maize, a genetically modified crop, on honeybee colonies. The researchers found no adverse effects on honey bee colony performance or overwintering survival when comparing colonies fed with Bt maize pollen to those fed with non-Bt maize pollen.

This finding and numerous others provide robust scientific evidence debunking the notion that GMOs are responsible for the decline in pollinator species. Instead, other factors — such as climate change, habitat loss, pesticide use, and diseases — contribute to pollinator decline . GMOs, in themselves, are not the primary cause of this decline.

Myth: GMOs Are Not Adequately Labeled.

Fact : Starting from January 1, 2022, a requirement for mandatory GMO labeling was implemented.

This labeling regulation entails that food products and their packaging must display a small seal or include text indicating whether they are "bioengineered" or "derived from bioengineering." The enforcement of this labeling rule is primarily carried out in response to complaints or reports of non-compliance.

“By providing a uniform national standard for labeling bioengineered foods, [the United States] can increase transparency in our food system and give consumers information about the bioengineered status of their foods,” said Anna Waller, marketing specialist with the USDA Agricultural Marketing Service, during a 2020 webinar .

Myth: GMOs Lack Significant Societal Benefits.

Fact : GMOs have brought several benefits, such as improved crop yields, enhanced nutritional content, reduced pesticide usage, and increased disease resistance, contributing to global food security and improved healthcare options.

GMOs have been extensively studied and scientifically proven to deliver significant societal benefits. Recent research has demonstrated the positive impact of GMOs in various areas. For instance, a meta-analysis found that genetically modified technology adoption has helped increase agricultural yields by up to 22%, reduce pesticide use by 37%, and raise farmer profits by 68%. This has contributed to improving global food security and reduced the environmental impact of agriculture.

Furthermore, a 2020 study published in the Journal of Nutrition highlighted that GMOs could address critical challenges such as malnutrition and vitamin deficiencies by enhancing the nutritional content of crops. These findings collectively support that GMOs are vital in addressing societal needs and advancing sustainable agriculture.

It's important to note that these myths are widely debunked by scientific evidence and expert consensus. However, public perception and understanding of GMOs can vary, and ongoing dialogue and education are crucial for informed decision-making.

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Genetically Modified Food

About genetically modified food, narrow the topic.

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Since the 1930s, several decades after the Austrian monk and scientist Gregor Mendel discovered genes—small heredity units in  DNA  by which parents pass along traits to their offspring—people have altered crops or animals by crossbreeding. Breeders select a certain trait, such as size or color, and by carefully choosing the parent plants or animals, develop new species of that organism. Tomatoes may be made plumper, grapes seedless, or oranges juicier. However, the process can take a long time. Often many seasons pass before growers achieve desired results.

For animals, these modifications can take even longer. If breeders want a heftier steer, they select parents who are larger and meatier. They mate the parents, wait for the calf to be born, and then wait for the calf to grow old enough to have babies. Then, the breeders mate it with another huge bull or cow and again wait until the resulting calf is mature enough to have babies itself. If breeders are working toward a specific trait, it may take generations of crossbreeding to attain the desired results.

( Opposing Viewpoints )

• How safe is genetically modified food?
• What are the possible dangers of genetically modified food? What are the possible benefits?
• What precautions should the government take to protect our food?
• Focus on the possibilities of genetically modifying a certain food, such as potatos or soy beans. Who would benefit from genetically modified food, the consumer or the producer?
• What is the evidence the illnesses and deaths from L-Tryptophan in 1989 was linked to genetic modification?
• Why did the European Commission require labeling for food that has been genetically modified? Why don't we have that in the U.S.?
• Why is there more press about genetically modified food in European countries than U.S.A.?
• Discuss genetically modified food and allergies, nutrition, antibiotic reserves, pesticides.
• Should the EPA, USDA, or FDA be given the task of conducting studies of long term effects of biotechnology?
• What are the ramifications of giving hormones to cattle or other animals?
• Why is there an interest in sterilized crops? What are the implications?
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• Last Updated: Feb 6, 2024 3:52 PM
• URL: https://libguides.broward.edu/GMO