Introduction The phenomena and practice of improving crop and animal species seem germane to humanity across every known documented civilization. Some of these methods include cross and selective ...hybridization, grafting among others. Genetically Modified Organisms (GMOs) are unique in that certain desirable genes or protein sequences are deleted, inserted or reengineered from the same or different species into a new organism.1 It is estimated that nearly 90% of all soybeans, corn, and cotton cultivated in the United States are genetically modified.2 The introduction of GMOs) continues to generate global debate. For instance, the introduction of GMOs in the United States was fraught with many debates much as it is even now in Canada and Europe.3 Opponents have often contested that GMOs may affect naturally occurring organisms, become resistant to antibiotics and potentially affect the environment and even humans. Some have raised questions on bioequivalence and safety of GMOs to non-GMOs. It is thus not surprising that the introduction of GMOs continue to generate unprecedented controversies with scientific, ethical, and even legal dimensions.4 Recently, the Parliament of Ghana debated and passed the “Plant Breeders Bill Act 2013” which ostensibly authorized the Center for Scientific and Industrial Research (CSIR) to conduct field trials for three GMOs.5 These GMOs are cowpea, rice, and sweet potatoes. The rationale for genetically modifying these organisms is to address specific needs, including food security, nutritional enrichments, and protection of the environment.6 As anticipated, this generated substantial public outcry throughout Ghana and beyond. What is behind this global ambivalence toward the acceptability of GMOs? Are these scientifically, legally, and ethically justified? Scope This paper will examine the debates and the challenges on GMOs in general with cryptic references to the Plant Breeders Bill as a case study. I will examine some of these challenges through the acuity of some ethical concepts, such as the uncertainty theory in resolving disagreements, beneficence/non-maleficence, and justice. I will also attempt to propose some policy, legal, and ethical solutions. The Debate on Genetically Modified Organisms (GMOs) As indicated above, GMOs comprise an insertion of a particular gene of interest into living organisms or the deletion of a gene due to some desirable traits.7 Sometimes, a particular gene or protein sequence deemed obnoxious may be spliced or eviscerated from the host genome so as to attain the expression of certain characteristic or traits.8 Genetic modifications of organisms have a wide scope of applications especially in bioengineering of plants and animals for therapeutic, commercial, and other novel purposes such as pest and weed control.9 Some of these GMOs are Bt-corn, Atlantic salmon, and Bt-cowpea.10 The introduction of new genes into different organisms has degenerated into contentious debates. Indeed, the hysteria of a new or “foreign gene” in a new host’s genome makes it unfathomable to many people and also raises serious questions. But are these technologies safe? What is the threshold in defining these products as safe? Questions on the possibility of transgenic introgressions into wild varieties of certain organisms such as corn or soybean have been justifiably raised even though no conclusive scientific data has substantively proven it nor disputed the assertions to date.11 Furthermore, one of the major socio-economic aspects of the debate is that small scale farmers may perpetually rely on the big corporations for GMO seeds, which culminates in a high cost in production. It seems society has trust in biotechnology products in general, but it is particularly ambivalent about GMOs. Some religions, especially of the Abrahamic traditions, have some dietary obligations enjoined on them. Some of these include the prohibition from eating pork. What arises is the question of whether or not a gene from a pig used to engineer a product such as a vegetable would constitute a transgression of these religious tenets? This is an important question in the debate prompting many to favor a complete labeling of GMO products.12 But does a particular gene in a genome define an entire organism? In view of these challenges, I will examine these questions with some ethical concepts. What about the socio-political context? It should be noted that, whereas in the US, most initiatives on introducing GMOs have been orchestrated by private companies such as Monsanto while in developing countries such as Ghana, the government has remained quiet on the introduction of GMOs. Some Ethical Challenges and Analysis One of the major challenges on the debate on GMOs is that there are many uncertainties or “disagreements”.13 This is further exacerbated by the pervasive phenomena of conceptual, factual, and evidential disagreements on GMOs.14 The question that emerges herein is: what are the best and most certain ethical frameworks to use in analyzing the debate on GMOs, especially as there are many uncertainties and unanswered questions? Does any single ethical theory suffice in responding to the debates? If so, which one? What makes the debate on GMOs seemingly divisive both within the scientific community and the general public as a whole? Indeed as Beauchamp noted “neither one morality nor ethical theory has the resources to provide a single solution to every moral problem.”15 Consequently, in this section, I will analyze these challenges through the nexus of the ethical framework of dealing with disagreements. 16 First of all, there are conceptual uncertainties or moral disagreements among scientists and even ethicists about GMOs.17 Some proponents postulate the argument that biotechnological innovations and the introduction of GMOs are good and novel human inventions in advancing the common good. Aligned with this is the idea that humanity has always improved living organisms in the past through methods such as grafting and domestication of wild crops and animals. Therefore, the introduction of GMOs is consistent with an intrinsic disposition of humans to improve naturally occurring living organisms. GMOs, such as the case of genetically modified cowpeas in Ghana, is to insure food security and enhance nutritional needs of people, and thus ameliorate the problem caused by the fact that nearly 30-70% of non-GMO cowpeas were lost during propagation and harvesting. Hence, the notion and the conception of resolving a seemingly significant natural problem should be accepted under the expediency of its novelty, rather than the presumption that GMOs are inherently bad.18 On the other hand, some have countered the above argument, suggesting that unlike other forms of biotechnological innovations such as crop and animal breeding, in GMOs, genes from unrelated species are introduced for specific purposes that may not be natural to the host organism(s).19 There is no certitude and data to substantiate the case that these new genes are substantively safe especially in the long term.20 Should the introduction of GMOs be halted until questions of uncertainty are addressed albeit resolved?21 This then leads us to the issue of disagreement based on insufficient information and evidence.22 The debate on GMOs is further compounded and enveloped with apparently insufficient information. Proponents of this view asserted that there are unreliable and insufficient data to make the case for GMOs. Furthermore, there seem to be many disagreements among scientists about some data on GMOs. 23 For example, some data suggests that GMOs are perilously invasive and may have altered other living organisms within an ecosystem, including humans.24 Currently, the FDA has endorsed the production and the release of GMOs while the European Food and Safety Authority (EFSA) has adopted a precautionary principle and banned GMOs in Europe. 25 The crust of the issue is that these are two credible scientific organizations mandated to ensure food and drug safety but both have stark disagreements on the information on GMOs. Both the FDA and EFSA seem to agree on the lack of scientific certitude and insufficient biodata on the safety of GMOs.26 To buttress this argument, proponents agree with the WHO statement that GMOs “...are not likely to present risks for human health”.27 Furthermore, the World Trade Organization’s (WTO) Sanitary and Phytosanitary Agreement (SPS) article 5.7 inter alia indicates that: “...in cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time”. 28 Given the apparent insufficiencies of the information on GMOs, it begs the questions as to whether ethicists have any formidable grounds to assume a particular position to be accurate or good! The third component to the uncertainty theory is based on the premise of factual disagreements. There is no doubt that there are many biodata on GMOs evidenced in the many scientific publications and peer reviewed information about scientific “facts” on the pros and cons of GMOs.29 On the contrary, some scientists have also demonstrated seemingly convincing biodata challenging and raising the question of safety of GMOs, allergenic reactions and eco-safety. For example, a seminal study conducted on the effect of GMO Bt-Corn on larvae and concluded that material from the bacterium Bacillus thuringiensis (Bt ) are generally thought to have “although plants transformed with genetic negligible impact on non-targe
Products derived from agricultural biotechnology is fast becoming one of the biggest agricultural trade commodities globally, clothing us, feeding our livestock, and fueling our eco-friendly cars. ...This exponential growth occurs despite asynchronous regulatory schemes around the world, ranging from moratoriums and prohibitions on genetically modified (GM) organisms, to regulations that treat both conventional and biotech novel plant products under the same regulatory framework. Given the enormous surface area being cultivated, there is no longer a question of acceptance or outright need for biotech crop varieties. Recent recognition of the researchers for the development of a genome editing technique using CRISPR/Cas9 by the Nobel Prize committee is another step closer to developing and cultivating new varieties of agricultural crops. By employing precise, efficient, yet affordable genome editing techniques, new genome edited crops are entering country regulatory schemes for commercialization. Countries which currently dominate in cultivating and exporting GM crops are quickly recognizing different types of gene-edited products by comparing the products to conventionally bred varieties. This nuanced legislative development, first implemented in Argentina, and soon followed by many, shows considerable shifts in the landscape of agricultural biotechnology products. The evolution of the law on gene edited crops demonstrates that the law is not static and must adjust to the
of society, informed by the experiences of 25 years of cultivation and regulation of GM crops. The crux of this review is a consolidation of the global legislative landscape on GM crops, as it stands, building on earlier works by specifically addressing how gene edited crops will fit into the existing frameworks. This work is the first of its kind to synthesize the applicable regulatory documents across the globe, with a focus on GM crop cultivation, and provides links to original legislation on GM and gene edited crops.
The EU has the probably strictest regulations in the world for the presence of GMOs in food and feed. These require the labeling of food and feed where the level of approved GMO exceeds 0.9% of ...unintentional adventitious presence. For non-approved GMOs the threshold is ‘zero’ and thus requires that cargoes containing GMOs non-approved GMOs are returned to the port of origin or are destroyed. The process of GMO safety approval is slow and subject to extensive political interference. However outside of Europe, new GMOs are being created, approved and cultivated at a rate exceeding that of EU approvals. Since current methods of cultivation, storage and transport do not permit complete segregation of GMO and non-GMO crops, some co-mingling must be expected. This leads to a peculiar situation where the EU is dependent on imports (particularly soybean for animal feed) from North and South America and yet, legally, must reject these imports since they contain low levels of unauthorized GMOs. Several authorative European reports indicate that this is not a sustainable situation and must result in feed shortages and price increases of meat and poultry. The solution is to either to modify EU regulations or to synchronize GMOs approvals on an international level.
The USA has constantly criticized the EU for its unscientific GMO regulations which it says amounts to trade protectionism. Very recently however, the USA has realized that other countries are now producing and cultivating their own GMOs, and that these are not authorized in the USA. The USA is thus proposing to set up its own system of GMO regulations which may bear a close similarity to those in Europe.
Genetically modified plants, in the following referred to as genetically modified organisms or GMOs, have been commercially grown for almost two decades. In 2010 approximately 10% of the total global ...crop acreage was planted with GMOs (James, 2011). More than 30 countries have been growing commercial GMOs, and many more have performed field trials. Although the majority of commercial GMOs both in terms of acreage and specific events belong to the four species: soybean, maize, cotton and rapeseed, there are another 20+ species where GMOs are commercialized or in the pipeline for commercialization. The number of GMOs cultivated in field trials or for commercial production has constantly increased during this time period. So have the number of species, the number of countries involved, the diversity of novel (added) genetic elements and the global trade. All of these factors contribute to the increasing complexity of detecting and correctly identifying GMO derived material. Many jurisdictions, including the European Union (EU), legally distinguish between authorized (and therefore legal) and un-authorized (and therefore illegal) GMOs. Information about the developments, field trials, authorizations, cultivation, trade and observations made in the official GMO control laboratories in different countries around the world is often limited, despite several attempts such as the OECD BioTrack for voluntary dissemination of data. This lack of information inevitably makes it challenging to detect and identify GMOs, especially the un-authorized GMOs. The present paper reviews the state of the art technologies and approaches in light of coverage, practicability, sensitivity and limitations. Emphasis is put on exemplifying practical detection of un-authorized GMOs. Although this paper has a European (EU) bias when examples are given, the contents have global relevance.
The combined availability of whole genome sequences and genome editing tools is set to revolutionize the field of fruit biotechnology by enabling the introduction of targeted genetic changes with ...unprecedented control and accuracy, both to explore emergent phenotypes and to introduce new functionalities. Although plasmid-mediated delivery of genome editing components to plant cells is very efficient, it also presents some drawbacks, such as possible random integration of plasmid sequences in the host genome. Additionally, it may well be intercepted by current process-based GMO regulations, complicating the path to commercialization of improved varieties. Here, we explore direct delivery of purified CRISPR/Cas9 ribonucleoproteins (RNPs) to the protoplast of grape cultivar
and apple cultivar such as
fruit crop plants for efficient targeted mutagenesis. We targeted
, a susceptible gene in order to increase resistance to powdery mildew in grape cultivar and
, and
in the apple to increase resistance to fire blight disease. Furthermore, efficient protoplast transformation, the molar ratio of Cas9 and sgRNAs were optimized for each grape and apple cultivar. The targeted mutagenesis insertion and deletion rate was analyzed using targeted deep sequencing. Our results demonstrate that direct delivery of CRISPR/Cas9 RNPs to the protoplast system enables targeted gene editing and paves the way to the generation of DNA-free genome edited grapevine and apple plants.
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