Safety Of Genetically Modified Organisms Research Articles

Genetically modified organisms (GMOs) and attached Biosafety and Biosecurity Concerns: Field practitioners’ perspective

With an agency established to oversee and regulate GMOs, the extent to which field practitioners align with the biosafety and biosecurity measures of GMOs in Nigeria remains a critical question. This study seeks to explore the perspectives of field practitioners with GMOs concerns with the technology, political and safety aspects within the Nigerian context. This research evaluation was conducted over four months (March to June 2022). It involved the distribution of questionnaires to 234 individuals, encompassing biosafety, biotechnology, and biosecurity practitioners in Abuja, Nigeria. The loadings of items have intrinsic consistency within the range of 0.733 to 0.875. Majority of the respondents expressed the view that Nigeria politicians and public interest groups were concerned about the potential allergenicity and antimicrobial resistance associated with GMOs. Three predictors: Perception on GMOs (Wald=0.031), GMOs safety assessment (Wald=0.674), and Regulation of GMOs (Wald=0.004) at df=1 have no significant effects on attacks related to GMOs as 92.3% of the respondents claimed not to suffer any attack related to GMOs products. Working experience [F (4, 233) =0.228, p=0.923] interaction with perception on GMOs was statistically not significant. The political class and public interest groups worries about GMOs products (Covariance= 5.509) share positive but not significant correlation at p=0.057 with Regulation of GMOs (Covariance= 7.841). Finally, GMOs and their products exist in Nigeria alongside a reliable regulatory body which had put up biosafety and biosecurity guidelines in controlling all GMOs related activities in order to make the environment safer and boost the populace confidence in GMOs

The evolution of China's regulation of agricultural biotechnology.

To ensure safe use of genetically modified organisms (GMOs), since 1993, China has made great efforts to establish and improve the safety regulatory system for GMOs. Here, we summarize and analyze the regulatory framework of agricultural GMOs, and the progress in regulatory approval of GM crops in China. In general, the development of GMO safety regulations underwent four stages: exploration (1993-2000), development (2001-2010), improvement (2011-2020) and current (2021-present) stage. The first formal regulation was promulgated in 1993, which provided a basis for further development of the regulations, during the exploration stage, when insect-resistant GM cotton, expressing genes from Bacillus thuringiensis (Bt), was approved for cultivation. During the development stage, the Chinese government issued a series of administrative measures, which covered almost all the fields relative to GMO safety when the basic regulatory system was established. Along with the controversy over GMO safety, the regulations have been further, and greatly improved, during improvement stage. From 2021, a few additional revisions have been made, and meanwhile, the new regulation on gene-edited crops was introduced with the development of biotechnology, forming a relative complete regulation and law system for China. The well-developed GMO regulations establishes a firm basis for safe use of GM crops in China. Currently, GM cotton and GM papaya have been widely grown on a large scale in China that have brought great economic and ecological benefits. In addition, 12 corn events, 3 soybean events, and 2 rice events have also obtained biosafety certification, but presently, these lines have yet to enter commercial production. However, several GM soybean and corn events have entered pilot industrialization, and can soon be expected to be commercially grown in China. In addition to planting, six GM crops, including soybean, corn, cotton, canola, papaya and sugar beet, with a total of 64 events, have been approved for import as processing material in China.

Strategic approaches to communicating with food consumers about genetically modified food

The use of genetically modified (GM) crops for food production is rising. This study surveyed consumers in the Republic of Korea to obtain general insights into their perceptions, knowledge, and use of GM crop-based food, their needs for information about GM foods, their GM food-purchasing intentions, their usual food-purchasing habits, and whether there are groups with particular demographic profiles and stances on GM foods that would benefit most from well-designed public education programs. In total, 1096 adults in the Republic of Korea underwent face-to-face interviews in 2017. The cohort composition was based on recent population data. Only 5.8% had a positive stance on GM foods, while 58.8% perceived GM foods as being risky to human health. While 50.3% thought that they were somewhat to very knowledgeable about GM organisms (GMO), their actual knowledge was low (<25% provided correct answers to three basic questions). Mass media was selected as the most common, powerful, and effective source of information. Experts such as professors and scientists were considered the most credible information sources. The “safety of GMO” was by far the most preferred topic for education. This reflects the huge anxiety of the consumers about GM-food safety. Indeed, a large proportion of consumers (54.7%) said they would avoid purchasing GM foods in the future. Future GM food-purchasing intentions related significantly with attitudes to, risk perception of, and knowledge about GM foods (all p < 0.001). Several target groups may benefit most from effective education programs: the elderly, consumers with a family member with an allergy, asthma, or atopy, people with a negative stance on GM foods and/or who perceive them to be risky, and people who strongly prefer environmentally friendly food. These findings on current consumer attitudes to GM foods will facilitate strategic approaches to educating the public about GMO and GM foods.

Transboundary Movements of Genetically Modified Organisms and the Cartagena Protocol: Key Issues and Concerns

Biotechnology or the engineering of the genetic material of species can give way to avenues of possibilities for the benefit of people, fauna and flora but also has the potential of posing untold and undiscovered threats to human beings and other living organisms. One of the first attempts to legislate on international rules on biotechnology can be traced back to article 19 of the Convention on Biological Diversity (CBD) in 1992. The CBD is indeed the first international legal instrument apart from the then European Community’s relevant directives to suggest that biotechnology is a matter of concern for the international community while providing a basis upon which more detailed procedures would be elaborated in the field of biosafety. While the CBD includes international rules on access to genetic resources, access to and the transfer of technology, the handling of biotechnology and the distribution of its benefits, it does not include a detailed regulation on genetically modified organisms (GMOs) and their possible adverse effects on the environment, human and animal health. It was only with the coming into existence of the Cartagena Protocol on Biosafety (Cartagena Protocol) to the CBD in 2000 that the safe transfer, handling and use of living modified organisms (LMOs) such as genetically engineered plants, animals, and microbes were at last being catered for, albeit leaving aside the broader categories of GMOs. Due to the need for the negotiators of this protocol to make compromises, there were still key issues on the international biosafety framework pertaining mainly to the scope of the GMOs to be covered by this protocol and by the Advanced Informed Agreement procedure; identification and traceability issues; and liability and redress issues.&#x0D; Nine years after the entry into force of the Cartagena Protocol the transboundary movements of GMOs have clearly increased with new categories of GMOs and genetically modified products to regulate. The debate on the safety of GMOs used for food and feed as well as the effects of GMOs on the receiving environment is still very lively throughout the world, amidst a lack of traceability of GMOs or epidemiological studies in the GMO-producing countries. However, there has been some progress on liability and redress with regard to damage resulting from the transboundary movement of LMOs with the adoption of rules and procedures for liability and redress in 2010 with the Nagoya-Kuala Lumpur Supplementary Protocol "(hereafter the Nagoya SP)" to the Cartagena Protocol, which is yet to enter into force. There are also concerns on the harmonisation of national biosafety regulation, risk assessment and risk management standards, the interpretation of socio-economic considerations, and the monitoring of compliance with the provisions of the Cartagena The scope of the GMOs covered by the Cartagena Protocol is discussed first, which discussion is followed by the discussion of identification and traceability issues, the harmonisation of national biosafety regulation, the harmonisation of risk assessment and risk management standards, the scope of the relevant socio-economic considerations, implementation, and concerns about the settlement of disputes.&#x0D;

Genetic Engineering and Human Mental Ecology: Interlocking Effects and Educational Considerations

This paper describes some likely semiotic consequences of genetic engineering on what Gregory Bateson has called “the mental ecology” (1979) of future humans, consequences that are less often raised in discussions surrounding the safety of GMOs (genetically modified organisms). The effects are as follows: an increased 1) habituation to the presence of GMOs in the environment, 2) normalization of empirically false assumptions grounding genetic reductionism, 3) acceptance that humans are capable and entitled to decide what constitutes an evolutionary improvement for a species, 4) perception that the main source of creativity and problem solving in the biosphere is anthropogenic. Though there are some tensions between them, these effects tend to produce self-validating webs of ideas, actions, and environments, which may reinforce destructive habits of thought. Humans are unlikely to safely develop genetic technologies without confronting these escalating processes directly. Intervening in this mental ecology presents distinct challenges for educators, as will be discussed.

Growing monstrous organisms: the construction of anti-GMO visual rhetoric through digital media

ABSTRACTThis paper explores the international controversy over genetically modified organisms (GMOs). We argue that the uncommonly high levels of opposition to genetically modified food in both the United States and in Europe can be attributed to the overwhelming success of the online visual campaign against GMOs. By exploiting the unique characteristics of the internet to create memetic images that can travel freely across linguistic and cultural borders, opponents of the technology have been able to refute rationalist claims about the safety of GMOs. In response to the single coherent narrative of scientific certainty, a diffuse set of challenges emerges. The risk of genetic engineering holds within it the potential for catastrophe, leaving the industries that produce and manufacture the technology in a perpetual state of crisis. Instead of a unified narrative of scientific certainty, each challenge presents a multiplicity of diffuse narratives that unsettle the public’s understanding of the risk presented by GMOs. We aim to augment traditional understandings of the way that publics may interact with the “public screen” by explicating one way in which dominance of the visual in mediated political discourse may privilege non-rational political decision making.

Regulation of Genetically Modified Food Use in the Russian Federation

Practical application of new methods of а plant genome transformation resulted in the need for strict regulation of the safety assessment process of genetically modified organisms of plant origin, intended for use in food. The devise of Genetically Modified Organisms (GMO) of plant origin safety assessment system, which is currently valid in the Russian Federation, was initiated in 1995-1996. Not only does the system accumulate all domestic and foreign experience, it also includes the latest scientific approaches, based on achievements of fundamental science. In the present article authors focused on issues of the basic legislative regulations of plant biotechnology in the Russian Federation, and approaches to the safety assessment of GM food and control over such food. GMO safety assessment is carried out at the stage of State registration. The subject of registration is novel food products derived from GMO, manufactured in the Russian Federation, as well as food products, entering the Russian Federation for the first time. In the system of medical and biological assessment of the GMO safety, along with general toxicological research, the study of specific types of toxicity in in vivo experiments takes a prominent place. In accordance with established research practice, which uses an integrated approach, and provides with the most complete and reliable information on potential reprotoxic, genotoxic, immunotoxic and allergenic effects of GMO, as well as enables to reveal possible unintended effects of genetic modification. From 1999 to 2016 22 GM lines passed the entire cycle of medical-biological investigations. By 2016 there had been amassed scientific foundation on GMO safety, which includes the analysis of result of research, carried out within the framework of GMO state registration in the Russian Federation, as well as domestic and international data, presented by scientific literature on the problem of biotechnological food safety, at both registration stage and post-registration monitoring stage. To sum up, in the Russian Federation the most essential issues, allowing to use GMO for food purpose have been resolved: 1) legislation, normative and methodical foundations, regulating safety assessment and control over GMO turnover, as well as ensuring customer awareness about presence of GMO in food products, have been created; 2) scientifically proven evidence on the lack of negative effects for human health, i.e. GMO safety has been amassed; 3) the possibility of control over GMO turnover throughout the food market of the country has been sustained.

Transboundary movements of genetically modified organisms and the Cartagena protocol: key issues and concerns

Biotechnology or the engineering of the genetic material of species can give way to avenues of possibilities for the benefit of people, fauna and flora but also has the potential of posing untold and undiscovered threats to human beings and other living organisms. One of the first attempts to legislate on international rules on biotechnology can be traced back to article 19 of the Convention on Biological Diversity (CBD) in 1992. The CBD is indeed the first international legal instrument apart from the then European Community’s relevant directives to suggest that biotechnology is a matter of concern for the international community while providing a basis upon which more detailed procedures would be elaborated in the field of biosafety. While the CBD includes international rules on access to genetic resources, access to and the transfer of technology, the handling of biotechnology and the distribution of its benefits, it does not include a detailed regulation on genetically modified organisms (GMOs) and their possible adverse effects on the environment, human and animal health. It was only with the coming into existence of the Cartagena Protocol on Biosafety (Cartagena Protocol) to the CBD in 2000 that the safe transfer, handling and use of living modified organisms (LMOs) such as genetically engineered plants, animals, and microbes were at last being catered for, albeit leaving aside the broader categories of GMOs. Due to the need for the negotiators of this protocol to make compromises, there were still key issues on the international biosafety framework pertaining mainly to the scope of the GMOs to be covered by this protocol and by the Advanced Informed Agreement procedure; identification and traceability issues; and liability and redress issues. Nine years after the entry into force of the Cartagena Protocol the transboundary movements of GMOs have clearly increased with new categories of GMOs and genetically modified products to regulate. The debate on the safety of GMOs used for food and feed as well as the effects of GMOs on the receiving environment is still very lively throughout the world, amidst a lack of traceability of GMOs or epidemiological studies in the GMO-producing countries. However, there has been some progress on liability and redress with regard to damage resulting from the transboundary movement of LMOs with the adoption of rules and procedures for liability and redress in 2010 with the Nagoya-Kuala Lumpur Supplementary Protocol "(hereafter the Nagoya SP)" to the Cartagena Protocol, which is yet to enter into force. There are also concerns on the harmonisation of national biosafety regulation, risk assessment and risk management standards, the interpretation of socioeconomic considerations, and the monitoring of compliance with the provisions of the Cartagena The scope of the GMOs covered by the Cartagena Protocol is discussed first, which discussion is followed by the discussion of identification and traceability issues, the harmonisation of national biosafety regulation, the harmonisation of risk assessment and risk management standards, the scope of the relevant socio-economic considerations, implementation, and concerns about the settlement of disputes. KEYWORDS: genetically modified organisms; transboundary movements; biosafety regulation; Cartagena Protocol; harmonisation.

No scientific consensus on GMO safety

A broad community of independent scientific researchers and scholars challenges recent claims of a consensus over the safety of genetically modified organisms (GMOs). In the following joint statement, the claimed consensus is shown to be an artificial construct that has been falsely perpetuated through diverse fora. Irrespective of contradictory evidence in the refereed literature, as documented below, the claim that there is now a consensus on the safety of GMOs continues to be widely and often uncritically aired. For decades, the safety of GMOs has been a hotly controversial topic that has been much debated around the world. Published results are contradictory, in part due to the range of different research methods employed, an inadequacy of available procedures, and differences in the analysis and interpretation of data. Such a lack of consensus on safety is also evidenced by the agreement of policymakers from over 160 countries - in the UN’s Cartagena Biosafety Protocol and the Guidelines of the Codex Alimentarius - to authorize careful case-by-case assessment of each GMO by national authorities to determine whether the particular construct satisfies the national criteria for ‘safe’. Rigorous assessment of GMO safety has been hampered by the lack of funding independent of proprietary interests. Research for the public good has been further constrained by property rights issues, and by denial of access to research material for researchers unwilling to sign contractual agreements with the developers, which confer unacceptable control over publication to the proprietary interests. The joint statement developed and signed by over 300 independent researchers, and reproduced and published below, does not assert that GMOs are unsafe or safe. Rather, the statement concludes that the scarcity and contradictory nature of the scientific evidence published to date prevents conclusive claims of safety, or of lack of safety, of GMOs. Claims of consensus on the safety of GMOs are not supported by an objective analysis of the refereed literature.

Retraction of a study on genetically modified corn: Expert investigations should speak louder during controversies over safety.

Over the past few years, genetically modified organisms (GMO) have gradually become more familiar after numerous reports of problems with GMO safety, such as genetically modified (GM) potatoes disrupting immunity, GM corn inducing tumors, and GM rice being fed to unwitting Chinese children. Every time, these reports cause panic among the population and lead to objections to GMO in various fora. After each incident, the scientific community has delivered its academic appraisal and refuted rumors through slow and cautious investigations and evaluations. Unfortunately, during each event media outlets quickly scare the public about food safety and ignore the ensuing comments from scientists. Although scientists have investigated each GMO crisis and reached scientific and rational conclusions, they have less ability to disseminate information than the media, so the public is not promptly informed of their rational and objective viewpoints as experts. Thus, scientists need greater ability to disseminate information from scientific investigations and evaluations in order to correct the intemperate reporting by attention-seeking media.

Do GMOs Accumulate Formaldehyde and Disrupt Molecular Systems Equilibria? Systems Biology May Provide Answers

Safety assessment of genetically modified organisms (GMOs) is a contentious topic. Proponents of GMOs assert that GMOs are safe since the FDA’s policy of substantial equivalence considers GMOs “equivalent” to their non-GMO counterparts, and argue that genetic modification (GM) is simply an extension of a “natural” process of plant breeding, a form of “genetic modification”, though done over longer time scales. Anti-GMO activists counter that GMOs are unsafe since substantial equivalence is unscientific and outdated since it originates in the 1970s to assess safety of medical devices, which are not comparable to the complexity of biological systems, and contend that targeted GM is not plant breeding. The heart of the debate appears to be on the methodology used to determine criteria for substantial equivalence. Systems biology, which aims to understand complexity of the whole organism, as a system, rather than just studying its parts in a reductionist manner, may provide a framework to determine appropriate criteria, as it recognizes that GM, small or large, may affect emergent properties of the whole system. Herein, a promising computational systems biology method couples known perturbations on five biomolecules caused by the CP4 EPSPS GM of Glycine max L. (soybean), with an integrative model of C1 metabolism and oxidative stress (two molecular systems critical to plant function). The results predict significant accumulation of formaldehyde and concomitant depletion of glutathione in the GMO, suggesting how a “small” and single GM creates “large” and systemic perturbations to molecular systems equilibria. Regulatory agencies, currently reviewing rules for GMO safety, may wish to adopt a systems biology approach using a combination of in silico, computational methods used herein, and subsequent targeted experimental in vitro and in vivo designs, to develop a systems understanding of “equivalence” using biomarkers, such as formaldehyde and glutathione, which predict metabolic disruptions, towards modernizing the safety assessment of GMOs.

The Development and Standardization of Testing Methods for Genetically Modified Organisms and their Derived ProductsF

As the worldwide commercialization of genetically modified organisms (GMOs) increases and consumers concern the safety of GMOs, many countries and regions are issuing labeling regulations on GMOs and their products. Analytical methods and their standardization for GM ingredients in foods and feed are essential for the implementation of labeling regulations. To date, the GMO testing methods are mainly based on the inserted DNA sequences and newly produced proteins in GMOs. This paper presents an overview of GMO testing methods as well as their standardization.

EU Regulation of GMOs. Law and Decision Making for a New Technology

In this book,1 Maria Lee makes a convincing case that regulation of genetically modified organisms (GMOs) is about much more than controlling risk. While regulation must necessarily address risks to the environment and to human and animal health, the regulatory sphere also extends far more broadly than this to cover matters such as coexistence, liability, consumer choice, and ownership. Lee's book is a valuable addition to the literature for those wishing to broaden their understanding of the range of legal disciplines involved in GMO regulation. While her analysis is focused on the EU, the underlying principles are pertinent for policy-makers in any society facing the difficult questions raised by development of agricultural biotechnology. Lee begins by examining the EU's regulatory framework for authorisation of GMOs and finds it wanting. Her fundamental criticism relates to its overwhelming focus on questions of risk. While she finds that the authorisation framework provides a rigorous mechanism by which to assess, contest, and debate the safety of GMOs, she suggests that it does not allow thorough consideration of GMOs as a ‘social problem’, as something that is ‘raising profound questions about the type of world we are creating’. Interestingly, she observes in Europe an increasing acceptance that science does not have all the answers and that the public has something to contribute to decision-making. Yet, she finds that while it is relatively simple to understand the importance of social values and public participation, it is far more difficult to establish a concrete meaning for them and to usefully incorporate them within a regulatory framework. The term ‘public participation’, for example, is capable of many meanings and has many purposes, from improving democracy to improving substantive results. Perhaps, not surprisingly, she finds that under the EU regulatory scheme, the authority of science as a tool of decision-making in practice and in law remains very powerful.

Animal feeding trials for assessing GMO safety: answers and questions.

Abstract The safety assessment of genetically modified (GM) plants and their derived food and feed is nowadays a matter of lively debate. Any nutritional consequence of GM food consumption needs to be considered, both in terms of possible changes in the levels of nutrients in the food itself, and in terms of direct or indirect, immediate or cumulative effects on the overall diet. From this point of view, several potential risks have been taken into consideration by scientists when evaluating the safety of GM organisms (GMOs) by animal feeding trials; in particular, the possibility has been considered that GM food effects might not be due to the introduced gene itself, but to the unintended consequences of its introduction, such as allergy induction, DNA transfer to gastrointestinal flora (including antibiotic resistance), production of toxic compounds (i.e. insecticidal proteins), persistence of herbicide residues in transgenic herbicide-tolerant plants, any kind of unintended effects associated with the expression of recombinant proteins in non-native hosts. In this review, an overview of the literature data is reported on the effects of GMO intake in different animal models, with the scope to outline the state of the art of the scientific research on this subject.

Ancestral Genetic Resources Provide an Alternative to GMO Crops

Concern about the effects of pesticides on human health and the environment, has been a major rationale for pro-moting&nbsp; transgenic crops, often&nbsp; referred&nbsp; to as genetically modified organisms (GMOs), or as genetically&nbsp; enhanced (GE) crops.&nbsp;&nbsp; Companies&nbsp; that sell genetically engineered crop plants claim that biotechnology offers a safe alterna-tive to agricultural chemicals and is&nbsp; necessary to feed the world&rsquo;s expanding human population. However, there are still many unknowns about the safety of GMOs for human health and the&nbsp; environment, and virtually nothing is known about&nbsp; how&nbsp; the&nbsp; genomes&nbsp; of&nbsp; organisms may&nbsp; be&nbsp; affected by horizontal transfer of alien genes into plants, animals, and even humans. An alternative approach&nbsp; to&nbsp; transgen-ic&nbsp; technology&nbsp; is&nbsp; the exploitation of beneficial genes&nbsp; from wild&nbsp; relatives of crop plants using conventional breeding methods. This paper describes how genetic engineering &nbsp;differs&nbsp; from conventional plant breeding,&nbsp; then compares and&nbsp; contrasts benefits&nbsp; from&nbsp; transgenic engineering with traditional methods of crop&nbsp; improvement. An example of how the ancestral genes model has been employed to im-part an insect resistance trait to corn based on native re-sistance&nbsp; from&nbsp; a wild&nbsp; relative&nbsp; is&nbsp; compared&nbsp; to&nbsp; transgenic corn with&nbsp; resistance&nbsp; to&nbsp; the same&nbsp; insect engineered with &nbsp;a transgene from a bacterium. Using the ancestral genes approach, harmful chemicals used to control the worst in-sect pest of corn can be eliminated with no&nbsp; consequenc-es to human health or the environment; whereas with the transgenic approach,&nbsp; there are many safety concerns&nbsp; in both arenas.

Consumer attitudes and acceptance of genetically modified organisms in Korea

Genetically modified organisms (GMOs) were first used to designate micro organisms that had had genes from other species transferred into their genetic material by the then‐new techniques of ‘gene‐splicing.’ Cultivation of GMOs has so far been most widespread in the production of soybeans and maize. The United States holds almost three‐fourths of the total crop area devoted to GMOs. Because many crops have been imported from the US, there is a large possibility for consumers to intake the products of GMOs in Korea. The safety of GMOs is not scientifically settled at this time, however. Additionally, the research regarding the GMOs issue of consumers has rarely been conducted in Korea. This study therefore focused on the consumer attitudes about GMOs and willingness to purchase them. The data were collected from 506 adults living in Seoul, Daegu and Busan, Korea, by means of a self‐administered questionnaire. Frequencies and chi‐square tests were conducted by SPSS. The results of the survey were as follows. First, the consumer concerns about GMOs were high but recognition was low; many respondents answered they did not have exact information about GMOs, although they had heard about them. Second, almost 93% of the respondents desired the labelling of GMOs. Third, the level of acceptance of GMOs was high; two‐thirds of the respondents showed that they were willing to buy GMOs. Finally, many respondents worried about the safety of GMOs in that 73% of the respondents primarily wanted to be informed about safety of GMOs. This study suggests that the consumer education about GMOs should be conducted through mass media and consumer protection organisations.

Assessment of GM Crops in Commercial Agriculture

The caliber of recent discourse regarding genetically modified organisms (GMOs) has suffered from a lack of consensus on terminology, from the scarcity of evidence upon which to assess risk to health and to the environment, and from value differences between proponents and opponents of GMOs. Towards addressing these issues, we present the thesis that GM should be defined as the forcible insertion of DNA into a host genome, irrespective of the source of the DNA, and exclusive of conventional or mutation breeding. Some defenders of the commercial use of GMOs have referred to the scientific work of GMO critics as "junk science." Such a claim is false and misleading, given that many papers critical of both the utility and safety of GMOs have been published in peer reviewed journals by respected scientists. In contrast, there is a dearth of peer reviewed work to substantiate the frequently heard assertions of either safety or utility in GMOs. The polar- ity, which now characterizes much of the public discourse on GMOs, reflects not simply scientific disagreement, but also disagreement in underlying value assumptions. Value differences strongly affect the assessment of both benefit and harm from GMOs. The concept of substantial equivalence occupies a pivotal position in the GMO risk assessment process that is used in both Canada and the US. A GMO judged to be substan- tially equivalent to a conventional product - as have all submissions to date - is presumed to be safe enough for commercialization. The conclusion of safety - from both human health and environmental perspectives - should be based on scientific evidence, corroborated by actual experimentation. However, regulators infer safety largely from assumptions-based reasoning, with little or no experimental validation. The judgement of safety because of substantial equivalence is a dubious argument by analogy.