GMOS and Political Stance: Global GMO Regulation, Certification, Labeling, and Consumer Preferences provides a foundational-to-current challenges resource for those involved in developing and applying regulations to these important resources. Beginning with basics of GMOs, the book first familiarizes the reader with the history, economic status, associated risks, global politics, and socio-economics of GMOs. From exploring the necessity of GMO regulations with the existing GMO technology as well as new gene editing technologies to discussion by GMO regulations experts (...) from different continents and countries, readers will find the information necessary to understand the laws, rules, regulations and policies at domestic and international scale. A last chapter delivers an update and future look on gene-edited food and feed and discusses the possibilities on the future risk assessment, legislation and regulation of gene-edited products. GMOS and Political Stance provides a unique and applicable synchronization of all regulatory information on GMOs to facilitate effective and efficient regulatory development and adherence." -- Amazon. (shrink)

This paper discusses the ethical and regulatory issues raised by ‘‘intragenics’’ – organisms that have been genetically modified using gene technologies, but that do not contain DNA from another species. Considering the rapid development of knowledge about gene regulation and genomics, we anticipate rapid advances in intragenic methods. Of regulatory systems developed to govern genetically modified organisms (GMOs) in North America, Europe, Australia, and New Zealand, the Australian system stands out in explicitly excluding intragenics from regulation. European systems are also (...) under pressure to exclude intragenics from regulation. We evaluate recent arguments that intragenics are safer and more morally acceptable than transgenic organisms, and more acceptable to the public, which might be thought to justify a lower standard of regulation. We argue that the exemption of intragenics from regulation is not justified, and that there may be significant environmental risks associated with them. We conclude that intragenics should be subject to the same standard of regulation as other GMOs. (shrink)

In order to responsibly protect certain cherished values, for instance, human or environmental health, privacy, or ‘human dignity’, societies see a need for oversight, guidance and regulation of de...

Bioethical thinking regarding biotechnology should play an important rolein our lives, views and legislation. The main debates have been and still are over theregulation, safety and moral status of certain applications of modern biotechnology,such as GMOs. There are fears about the technology being autonomous without publiccontrol due to its strategic nature. Awareness of technological impact on modern life isbecoming more apparent as the application of biotechnology continues to develop. Howthen can we create a platform for handling biotechnology in a way (...) that aligns with ourviews on the good life, ie. in a healthy, beneficial and environmentally sustainable way?This article therefore raises for discussion some important issues to considerregarding the ethical dimensions of technology and how it is used. Is it applied to thegreater good? And do current regulations, or the lack of them, violate our responsibilitiesto others by not allowing them to choose whether they knowingly and voluntarilyassume the risks of ingesting these GM substances? (shrink)

Is it necessary to contrast the spreading process of genetic engineering in the agri-food stuff sector? Can EU rules really consider the impact of this brand new technologies on biology and, consequently, on public health? Despite the general trend, a firm opposition is what is happening in some Regions of Italy, where GMOs production and placing on the market are foibidden.

Law is often linked to ethics and morality. Regulations of genetically modified organisms ensue from a discussion on how well the law is composed to accommodate ethical considerations. The precautionary principle and biotechnology have undeniable moral connotations. Besides, the principle has socio-economic implications. The application of the precautionary principle in plant breeding should be legally justified on the basis of the best available evidence. On the other hand, scientific information cannot provide all the necessary information on which a risk (...) management decision should be based. This article addresses the issue of gap between science, ethics, and socio-economic considerations related to the cultivation and authorisation of GM crops. (shrink)

In recent years there has been renewed interest in the participation of lay people in regulatory procedures. The debate peaked in the 1980s with the anti-nuclear movements and again more recently as a reaction to the food scandals of the mid-1990s. In the wake of the bovine spongiform encephalopathy (BSE) crisis there has been a proliferation of European Community rules on the production, processing and retailing of food products, along with the multiplication of scientific committees in order to cope with (...) increased ... (shrink)

A growing number of countries in sub-Saharan Africa are considering legalizing the growth of genetically modified organisms. Furthermore, several projects are underway to develop transgenic crops tailored to the region. Given the contentious nature of GMOs and prevalent anti-GMO sentiments in Africa, a robust ethical analysis examining the concerns arising from the development, adoption, and regulation of GMOs in sub-Saharan Africa is warranted. To date, ethical analyses of GMOs in the global context have drawn predominantly on Western philosophy, dealing with (...) Africa primarily on a material level. Yet, a growing number of scholars are articulating and engaging with ethical theories that draw upon sub-Saharan African value systems. One such theory, Ubuntu, is a well-studied sub-Saharan African communitarian morality. I propose that a robust ethical analysis of Africa's agricultural future necessitates engaging with African moral theory. I articulate how Ubuntu may lead to a novel and constructive understanding of the ethical considerations for introducing GMOs into sub-Saharan Africa. However, rather than reaching a definitive prescription, which would require significant engagement with local communities, I consider some of Ubuntu's broader implications for conceptualizing risk and engaging with local communities when evaluating GMOs. I conclude by reflecting on the implications of using local moral theory in bioethics by considering how one might negotiate between universalism and particularism in the global context. Rather than advocating for a form of ethical relativism, I suggest that local moral theories shed light on salient ethical considerations that are otherwise overlooked. (shrink)

The main purpose of The NorwegianGene Technology Act (1993) is to enforcecontainment of genetically modified organisms(GMOs) and control of GMO releases.Furthermore, the Act intends to ensure that``production and use of GMOs should take placein an ethically and socially justifiable way,in accordance with the principle of sustainabledevelopment and without detrimental effects tohealth and the environment.'' Hence it isobvious that, for the Norwegian authorities,sustainable development is a normativeguideline when evaluating acceptableconsequences of GMO use and production. Inaccordance with this, we have investigated theextent (...) to which the sustainability criteriawere decisive for the destiny of one approvedand one declined application of geneticallymodified plant release. The presentunderstanding of the ecological,socio-economical, and cultural consequences ofGMO use and release is fragmentary anduncertain. We consider the PrecautionaryPrinciple and the notion of equitabledistribution as key issues within thesustainable development framework, henceconstituting important foundations for ouranalyses. The Act is legitimizingsustainability criteria, but does not seem tosecure their conversion into concrete action.We envisage a more conscious implementation ofthe Norwegian Gene Technology Act.Sustainability concerns ecological, economical,and social values, and these can only beensured through long-term thinking, initiationof independent risk-associated research, andbroad involvement of all stakeholders in theevaluation of GMO issues and concerns. (shrink)

In public debate over agricultural biotechnology, at issue hasbeen its self-proclaimed aim of further industrializingagriculture. Using languages of ’risk‘, critics and proponentshave engaged in an implicit ethics debate on the direction oftechnoscientific development. Critics have challenged thebiotechnological R&D agenda for attributing socio-agronomicproblems to genetic deficiencies, while perpetuating the hazardsof intensive monoculture. They diagnosed ominous links betweentechnological dependency and tangible harm from biotechnologyproducts.In response to scientific and public concerns, theEuropean Community enacted precautionary legislation for theintentional release of genetically modified organisms (GMOs). (...) Inits implementation, choices for managing and investigatingbiotechnological risk involve an implicit environmental ethics.Yet the official policy language downplays the inherent valuejudgments, by portraying risk regulation as a matter of’objective‘ science.In parallel with safety regulation, thestate has devised an official bioethics that judges where to’draw the line‘ in applying biotechnological knowledge, as ifthe science itself were value-free. Bioethics may also judge howto ’balance‘ risks and benefits, as if their definition were notan issue. This form of ethics serves to compensate for theunacknowledged value-choices and institutional commitmentsalready embedded in R&D priorities.Thus the state separates’risk‘ and ’ethics‘, while assigning both realms to specialists.The risk/ethics boundary encourages public deference to theexpert assessments of both safety regulators and professionalethicists. Biotechnology embodies a contentious model of controlover nature and society, yet this issue becomes displaced andfragmented into various administrative controls. At stake arethe prospects for democratizing the problem-definitions thatguide R&D priorities. (shrink)

Commercialization of genetically modified organisms (GMOs) have sparked profound controversies concerning adequate approaches to risk regulation. Scientific uncertainty and ambiguity, omitted research areas, and lack of basic knowledge crucial to risk assessmentshave become apparent. The objective of this article is to discuss the policy and practical implementation of the Precautionary Principle. A major conclusion is that the void in scientific understanding concerning risks posed by secondary effects and the complexity ofcause-effect relations warrant further research. Initiatives to approach the acceptance or (...) rejection of a number of risk-associated hypotheses is badly needed. Further, since scientific advice plays a key role in GMOregulations, scientists have a responsibility to address and communicate uncertainty to policy makers and the public. Hence, the acceptance of uncertainty is not only a scientific issue, but is related to public policy and involves an ethical dimension. (shrink)

The risks of uncontrolled dissemination of GMOs has made it clear that biosafety is a very relevant matter that goes beyond the State boundaries. This approach has had its corresponding reflection at the policy level, which reveals that the public powers and the legislators have been sensitive to this existing preoccupation in ever-growing sectors of society. From the European regulations, one can deduce a set of principles, which must guide the decisions of the public powers in matters related to (...) biosafety: precaution, authorisation and inspection, “step by step”, “case by case”, traceability and transparency, among other. (shrink)

In spite of stricter provisions inthe new EU directive on deliberate release ofgenetically modified organisms (GMOs), criticsstill advocate a moratorium on permits forcultivation of GMOs. However, in an attempt tomeet concerns raised by the public, thedirective explicitly gives Member States thepossibility to take into consideration ethicalaspects of GMOs in the decision-making. Thisarticle investigates the potential effects ofsuch formulation by means of an empiricalanalysis of experiences gained the last yearsfrom similar Swedish regulations for GMOs,aiming at promoting sustainable development.The faulty implementation (...) shown in the Swedishcase indicates that legal stipulations forethics as such have limited importance. It issuggested that public participation is animportant factor for successful implementationof the ethics of sustainable development. (shrink)

Genetically modified organisms are a technology now used with increasing frequency in agriculture. Genetically modified seeds have the special characteristic of being living artefacts that can reproduce and spread; thus it is difficult to control where they end up. In addition, genetically modified seeds may also bring about uncertainties for environmental and human health. Where they will go and what effect they will have is therefore very hard to predict: this creates a puzzle for regulators. In this paper, I use (...) the problem of contamination to complicate my ascription of forward-looking moral responsibility to owners of genetically modified organisms. Indeed, how can owners act responsibly if they cannot know that contamination has occurred? Also, because contamination creates new and unintended ownership, it challenges the ascription of forward-looking moral responsibility based on ownership. From a broader perspective, the question this paper aims to answer is as follows: how can we ascribe forward-looking moral responsibility when the effects of the technologies in question are difficult to know or unknown? To solve this problem, I look at the epistemic conditions for moral responsibility and connect them to the normative notion of the social experiment. Indeed, examining conditions for morally responsible experimentation helps to define a range of actions and to establish the related epistemic virtues that owners should develop in order to act responsibly where genetically modified organisms are concerned. (shrink)

The European Court of Justice’s recent ruling that the new techniques for crop development are to be considered as genetically modified organisms under the European Union’s regulations exacerbates the need for a critical evaluation of those regulations. The paper analyzes the regulation from the perspective of moral and political philosophy. It considers whether influential arguments for restrictions of genetically modified organisms provide cogent justifications for the policies that are in place, in particular a pre-release authorization requirement, mandatory labelling, (...) and de facto bans (in the form of withholding or opting out of authorizations). It is argued that arguments pertaining to risk can justify some form of pre-release authorization scheme, although not necessarily the current one, but that neither de facto bans nor mandatory labelling can be justified by reference to common arguments concerning naturalness, agricultural policy (in particular the promotion of organic farming), socio-economic effects, or consumers’ right to choose. (shrink)

A radical reform of the agri-food biotech regulation in the EU is considered in many quarters as a pressing necessity. Indeed, two important decisions on the legal status of the so-called New Breeding Techniques are expected shortly. In order to clarify some basic aspects of the complex scenario, after a brief introduction regarding the “GMO” fallacy, we offer our point of view on the following facets: A faulty approach is frequent in the discussion of the agri-food regulation; NBTs, genome editing (...) may lead to the disappearance of the “GMO” meme; Beyond health and safety issues: socio-economic considerations; Sustainability: the comprehensive, meaningful starting point of a positive reform; The theoretical and legal basis for the reform are already contained in the EU’s general guidelines to legislation. (shrink)

The “Lošinj Declaration on Biotic Sovereignty” is a novelty in the consideration of the environment and life in general and a unique document on a global scale. Until the advent of the Declaration, the environment was usually considered in an instrumentalist way, following the prevailing techno-scientific paradigm. The Declaration introduces biotic sovereignty as the starting point for the debate on GMOs, from which the harmfulness or potential benefits of genetic engineering can be assessed. The protection of biotic sovereignty should be (...) one of the crucial values that European and Croatian citizens should defend in the upcoming struggle to change and probably drastically reduce the regulatory regime for genetically modified crops in the European Union and thus also in Croatia. In this paper, we highlight the importance of the “Lošinj Declaration on Biotic Sovereignty” in the context of the emergence of new gene regulation techniques that are becoming a threat to biotic sovereignty. We analyse the lobbying process against the ruling C-528/16 using the example of the scientists united in the network EU-SAGE. The central part of the paper analyses the controversy over a new European Commission study on new genetic techniques and the political context of the conflict between the European Commission and the European Parliament over the authorisation of new seed varieties of genetically modified crops. (shrink)

This paper discusses strategic decision making in firms pursuing biotechnology innovation and the influence of risk regulation on firm strategy. Data from three research projects, involving interviews with over 60 managers from agricultural and food related biotechnology companies and also over 60 key participants in the regulatory process in the UK and EC, shows a diversity of strategy and opinion. While some industry representatives identified new risk regulations governing the release of genetically manipulated organisms (GMOs) as the primary constraint (...) on biotechnology innovation, the findings of the study painted a more complex picture. The controversies surrounding the issue of risk regulation and its impact on innovation are best understood if viewed in the context of other political and economic factors. We conclude that the actual impact of risk regulation on industry strategies is probably less than the rhetoric of industry lobbyists would suggest. At the same time, the very act of lobbying so forcefully could lead to a public backlash against industry that would be much more damaging than the regulation itself. (shrink)

In this article, we address the public issue of mandatory Genetically Modified Organism (GMO) retail food labeling in the U.S., first by reviewing the policy arguments both in support and against labeling food containing GMOs; second, by describing the existing U.S. federal regulatory system pertaining to GMO labeling, and why it does not presently require labeling of food containing GMOs; third, by reviewing and interpreting the results of studies of American consumer attitudes toward mandatory GMO retail food labeling; fourth, by (...) evaluating, through the utilization of issue life cycle analysis in the nonmarket environment, where the issue of GMO retail food labeling stands in the national public policy process; fifth, summarizing the state of scientific evidence addressing the safety of GMO foods and the existing regulatory and public policy environment for this issue; and sixth, offering legislative and litigation strategies for the mainstream food nonmarket strategy framework to formally assess the GMO industry to protect their interests and those of American consumers not concerned with GMO food ingredients, while offering a voluntary labeling strategy for firms responding to and recognizing the “rights” of American consumers who “choose” to purchase non‐GMO food products. (shrink)

The commercial introduction of genetically modified organisms (GMOs) has revealed a broad range of views among scientists and other stakeholders on perspectives of genetic engineering (GE) and if and how GMOs should be regulated. Within this controversy, the precautionary principle has become a contentious issue with high support from skeptical groups but resisted by GMO advocates. How to handle lack of scientific understanding and scientific disagreement are core issues within these debates. This article examines some of the key issues affecting (...) precaution as a legal standard and as an approach to the use of science in decision-making processes. It is pointed out that there is a need for reflection over the level of scientific evidence required for applying the precautionary principle as well as who should have the burden of proof when there are uncertainties. Further, an awareness of the broader scientific uncertainties found in GMO risk assessment implies that a precautionary approach must be elaborated: both for acknowledging uncertainties and for identification of scientific responses. Since precaution is an important issue within the sustainable development framework, it is suggested that sustainability can provide a normative standard that can help to reveal the influence and negotiate the importance of the various forms of uncertainty. Wise management of uncertainties and inclusion of normative aspects in risk assessment and management may help to ensure sustainable and socially robust GMO innovations at present and in the future. (shrink)

New genomic techniques (NGTs) are powerful technologies with the potential to change how we relate to our food, food producers, and natural environment. Their use may affect the practices and values our societies are built on. Like many countries, the EU is currently revisiting its GMO legislation to accommodate the emergence of NGTs. We argue that assessing such technologies according to whether they are ‘safe enough’ will not create the public trust necessary for societal acceptance. To avoid past mistakes of (...) under- or miscommunication about possible impacts, we need open, transparent, and inclusive societal debate on the nature of the science of gene (editing) technologies, on how to use them, and whether they contribute to sustainable solutions to societal and environmental challenges. To be trustworthy, GMO regulation must demonstrate the authorities’ ability to manage the scientific, socio-economic, environmental, and ethical complexities and uncertainties associated with NGTs. Regulators and authorities should give equal attention to the reflexive and the emotional aspects of trust and make room for honest public and stakeholder inclusion processes. The European Group of Ethics in Science and Technology’s recent report on the Ethics of Genome Editing (2021) is important in calling attention to a series of fundamental issues that ought to be included in debates on the regulation and use of NGTs to ensure public trust in these technologies and in regulating authorities. With the great power of NGTs comes great responsibility, and the way forward must be grounded in responsible research, innovation, and regulation. (shrink)

In this chapter, Gary Comstock considers whether it is ethically justified to pursue genetically modified ( GM) crops and foods. He first considers intrinsic objections to GM crops that allege that the process of making GMOs is objectionable in itself. He argues that there is no justifiable basis for the objections- i.e. GM crops are not intrinsically ethically problematic. He then considers extrinsic objections to GM crops, including objections based on the precautionary principle, which focus on the potential harms that (...) may result from the adoption of GM organisms. He argues that these concerns have some merit. However, they do not justify giving up GM crops altogether. Instead, they require that GM crops be developed carefully and with appropriate oversight. Comstock then presents the positive case for GM crops that he endorses. It is based on three considerations: (i) the right of people to choose to adopt GM technology; (ii) the balance of likely benefits over harms to consumers and the environment from GM technology; and (iii) the wisdom of encouraging discovery, innovation, and careful regulation of GM technology. (shrink)

The UN Cartagena Protocol onBiosafety adopted in Montreal, 29 January, 2000and opened for signature in Nairobi, 15–26 May,2000 will exert a profound effect oninternational trade in genetically modifiedorganisms (GMOs) and their products. In thispaper, the potential effects of variousarticles of the Protocol on international tradein GMOs are analyzed. Based on the presentstatus of imports of GMOs and domestic researchand development of biotechnology in China,likely trends in imports of foreign GM food andrelated products after China accedes to WTO isexplored. Also, China's (...) potentialcountermeasures to control and regulate importsof GMOs in line with implementation of theProtocol are discussed. China, in recent times,has increased its food and agricultural importssubstantially from USA and Canada. Chinaimported soybean 10.42 mill. tons in 2000 andabout 15 mill tons in 2001, of which majorityare from USA where GM soybean accounts for60%. The plantation of US Monsanto'stransgenic Bt cotton was increased to more than1 million ha in China in 2001. Though China haspaid great attention to develop biotechnology,it appears to have little scope to export GMOsand GM products. So China may consider a rangeof administrative measures to implement theCartagena Protocol and to regulate its importof GMOs and GM agricultural products.Consequently, the Regulation on Safety ofAgri-GMOs was issued on June, 2001 and followedthree detailed rules issued in Jan. of 2002,with a priority to limit foreign GMOs importingby safety certification and labeling system.These were outlined taking into accountpolicies adopted in Western countries such asgreen barriers to international trade. (shrink)

Smallholder producers are the collective most likely to be affected by the introduction of GMOs globally, yet the least included in public debates and consultation about the development, implementation or regulation of this agricultural biotechnology. Why are the voices and arguments of smallholder farmers being excluded from national and international GM debates and regulation? In this article, we identify barriers which prevent smallholder farmers in Mexico from having a voice in public political, economic, scientific and social fori regarding the GM (...) maize controversy. Through the analysis of empirical data from a case study in Mexico, we identify political, institutional, economic and ontological reasons that lie behind that exclusion. We conclude with an appraisal of smallholder farmers’ perspectives on GM maize and their visions of Mexico’s rural future, within which they demand a meaningful and rightful space. (shrink)

Scientific risk evaluations are constructed by specific evidence, value judgements and biological background assumptions. The latter are the framework-setting suppositions we apply in order to understand some new phenomenon. That background assumptions co-determine choice of methodology, data interpretation, and choice of relevant evidence is an uncontroversial claim in modern basic science. Furthermore, it is commonly accepted that, unless explicated, disagreements in background assumptions can lead to misunderstanding as well as miscommunication. Here, we extend the discussion on background assumptions from basic (...) science to the debate over genetically modified (GM) plants risk assessment. In this realm, while the different political, social and economic values are often mentioned, the identity and role of background assumptions at play are rarely examined. We use an example from the debate over risk assessment of stacked genetically modified plants (GM stacks), obtained by applying conventional breeding techniques to GM plants. There are two main regulatory practices of GM stacks: (i) regulate as conventional hybrids and (ii) regulate as new GM plants. We analyzed eight papers representative of these positions and found that, in all cases, additional premises are needed to reach the stated conclusions. We suggest that these premises play the role of biological background assumptions and argue that the most effective way toward a unified framework for risk analysis and regulation of GM stacks is by explicating and examining the biological background assumptions of each position. Once explicated, it is possible to either evaluate which background assumptions best reflect contemporary biological knowledge, or to apply Douglas' 'inductive risk' argument. (shrink)

The current debate about labeling genetically engineered (GE) food focuses on food derived from GE crops, neglecting food derived from GE animals. This is not surprising, as GE animal products have not yet reached the market. Participants in the debate may also be assuming that conclusions about GE crops automatically extend to GE animals. But there are two GE animals - the Enviropig and the AquAdvantage Bred salmon - that are approaching the market, animals raise more ethical issues than plants, (...) and U.S. regulations treat animal products differently from crops. This paper therefore examines the specific question of whether there should be mandatory labeling on all food products derived from GE animals. We examine the likely regulatory pathways, salient differences between GE animals and GE crops, and relevant social science research on consumers’ attitudes. We argue that on any of the likely pathways, the relevant agency has a democratic obligation to require labeling for all GE animal food products. (shrink)

This paper examines the “biotechnology problem” in the history of molecular biology, namely the alleged reinvention of a basic academic discipline looking for the logic of life, into a typical technoscientific enterprise, closely related to agriculture, medicine, and the construction of markets. The dominant STS model sees the roots of this shift in a radical change of the regime of knowledge production. The paper argues that this scheme needs to be historicized to take into account the past in our biotech (...) present. Looking at the development of breast cancer genetic testing and GMOs as examples of mounting issues of intellectual property, risk and regulation, the paper also argues that historians of biology should pay closer attention to the political, the economical and the legal changes of the last thirty years. Solving the biotech problem requires new categories. The notion of “way of regulating” is given as an example of such notions linking the local and the global. (shrink)

I claim that differences in the importance attached to economic liberty are more important in debates over the use of genetically modified organisms (GMOs) in agriculture than disagreements about the precautionary principle. I will argue this point by considering a case study: the decision by the U.S. Animal and Plant Health Inspection Service (APHIS) to grant nonregulated status to Roundup Ready soy. I will show that the unregulated release of this herbicide-resistant crop would not be acceptable morally unless one places (...) a very high premium on economic liberty. This is true even if one takes a sound science attitude to unknown risks, rather than a precautionary attitude. I concede that it may not have been within APHIS’s legislative mandate to regulate Roundup Ready soy further, but for those of us who do not put a high premium on economic liberty, this only calls for extending regulatory oversight of GMOs. (shrink)

Roughly 20 percent of organic cropland wasdevoted to produce compared to only 3 percent forconventional agriculture in 1995. At the otherextreme, only 6 percent of organic cropland was incorn production while 25 percent of all croplandproduced corn. Only 30 percent of all organicfarmland was in pasture and rangeland compared to 66percent of all farmland. Clearly, these differencesreflect the greater importance of meat and dairyproduction in agriculture overall than in the organicsubsector. In recent years, the organic industry hasgrown not only in (...) volume but in products offered,moving well beyond fresh produce into dairy, snacks,and frozen foods. The estimated growth in retail salesof organic foods averaged over 20 percent a year forthe last eight years compared to only two percent inthe food industry overall, reaching an estimated $4.5billion in 1998. The mix of commodities produced atthe farm level have and will continue to change inresponse to several dynamic forces, including consumerdemand, regulation, and consolidations, mergers, andmainstream entrants at the farm, manufacturing, andretail levels. Consumer demand for organic foods hasbeen spurred by a number of factors including concernsover pesticide residues on foods, food produced usinggenetically modified organisms (GMOs), and hormones indairy and meat products. These concerns coupled withthe overall increase in demand for convenience foodsexplain the phenomenal recent growth of over 70 percent in sales of organic snacks, candy, and frozenfoods. The result has been increased demand forGMO-free grains for snacks, cereals, soy products, andfeed for dairy cows. The recent allowance by USDA forthe labeling of meat and poultry as organic willaccelerate already heightened demand for organic grainand feed from the organic dairy industry. Although thefastest growth in organic foods has been in categoriesother than produce, clearly produce plays an importantrole in the consumers decision on where to shop, anddemand should increase with the overall increase inthe number of organic consumers. Market outlets nowinclude sophisticated natural food store chains,gourmet specialty stores, and e-commerce, allowing fora broadened array of products. Mainstream agriculturalproducers, manufacturers, and supermarket chains haveentered the organic marketplace at a time of lowprices for commodities at the farm gate, fiercecompetition for retail shelf space, and increasinglysophisticated targeting of consumers. Inevitably,these changes in food products offered and in retailoutlets will lead to an organic agriculture thatincreasingly resembles the conventional foodindustry. (shrink)

This survey on biotechnology and bioethics was carried out on national random samples of the public and scientists in November 2000-January 2000 throughout Japan, and attendees at the Novartis Life Science Forum held on 29 September, 1999 in Tokyo. The sample size was 297, 370, and 74 respectively. While there is better awareness of GMOs in 2000 compared to 1991; the trend shows an increase in the perceived risks of GMOs followed by growing resistance in Japan. While a majority of (...) persons believed genetic engineering would make life better over the next twenty years, the proportion of respondents who thought genetic engineering would make life worse over the next twenty years doubled from 1997 to 2000. Respondents were asked whether they had heard about applications in several areas and the order of familiarity was: pest-resistant crops, human genes in bacteria, mouse to develop cancer, food and drinks, pigs with human hearts and pre-implantation diagnosis. A divide of opinion can be seen when the results on benefit, risk and moral acceptability of applications of biotechnology by the public are compared to the forum and scientist samples.A significant change in the acceptance of the public occurred in 2000 where only 22% agreed on the moral acceptability of GM food compared to 41% in 1997. In 2000 fewer people said they are willing to buy genetically modified fruits that taste better compared to 1997. The results show less public support for use of gene therapy than 1993 and twice as many scientists rejected gene therapy than they did in 1991.When asked whom is best placed to regulate modern biotechnology, the respondents were overwhelmingly in favor of international regulatory bodies, such as the United Nations and the World Health Organization, rather than national bodies. The comparison between scientists and public is interesting, however the more enthusastic sample were participants from the Novartis Life Science Forum with its mixed occupations. (shrink)

In public debate GMPs are oftenreferred to as being unnatural or a violationof nature. Some people have serious moralconcerns about departures from what is natural.Others are concerned about potential risks tothe environment arising from the combination ofhereditary material moving across naturalboundaries and the limits of scientificforesight of long-term consequences. To addresssome of these concerns we propose that anadditional element in risk assessment based onthe concept of familiarity should beintroduced. The objective is to facilitatetransparency about uncertainties inherent inthe risk assessment of (...) the GMP. Familiarityconventionally involves data and experiencerelating to the plant species and the ecosystemin question. We would like to extend thisconcept to the molecular level of plantbreeding and suggest that GMP characteristicsshould be compared to a reference baselinedetermined by conventional breeding techniques.Three GMPs are ranked according to familiarityat the plant and ecosystem level and themolecular level. The approach may help tointegrate discussion of the scientificarguments and moral questions raised in thedebate about GMOs by providing an operationalscheme within which moral concerns are broughtwithin the framework of science-based riskassessment. (shrink)

In Europe the use of genetically modified (GM) crops in food production has so far failed to gain wide public approval. Ordinary people are concerned about issues not covered by the existing regulation, including usefulness and unnaturalness. In response, particularly to worries about unnaturalness, biotechnologists have suggested that inserted genes should derive only from the plant itself, or from close relatives. This paper examines public perceptions of these so-called ‘cisgenic crops’ and asks whether the public shares the idea that they (...) are less unnatural and thus more acceptable than transgenic plants. Using five focus group interviews, we identified five lines of argument about naturalness with a bearing on the assessment of cisgenic crops as well as GM crops in general. The paper concludes that, depending on perceptions of naturalness, some people would agree that cisgenic crops are more acceptable than their transgenic counterparts. The finding that ordinary people value different aspects of naturalness may be relevant to a broader audience than just those interested in gene technology. It cautions against a simplistic interpretation of what counts as ‘natural’. (shrink)

Investigates the resolution of contradictions and ambiguous derogations in a code, by means of the imposition of partial orderings.

The new scientific acquisitions are numerous and even more are their future promises. The debate on bio-technologies involves the fundamental rights of the individual and the advancements in research must merge with the supremacy of the human being on the interests both of the ‘science’ and of society at large. In the attempt to combine ‘democracy’ with techno-scientific issues, Law has turned from pure technical rules (meant to reflect, without any critique, some knowledge) into a tool meant to fill cognitive (...) gaps and its role is showing to be not only crucial, but also innovative for legal professionals themselves. (shrink)

Private associations abounded in the ancient Greek world and beyond, and this volume provides the first large-scale study of the strategies of governance which they employed. Emphasis is placed on the values fostered by the regulations of associations, the complexities of the private-public divide and the dynamics of regional and global networks and group identity. The attested links between rules and religious sanctions also illuminate the relationship between legal history and religion. Moreover, possible links between ancient associations and the (...) early Christian churches will prove particularly valuable for scholars of the New Testament. The book concludes by using the regulations of associations to explore a novel and revealing aspect of the interaction between the Mediterranean world, India and China. (shrink)

World Athletics have introduced regulations preventing female athletes with certain differences in sex development from competing in the female category. We argue these regulations are not justified and should be removed. Firstly, we examine the reasoning and evidence underlying the position that these athletes have a substantial mean difference in performance from other female athletes such that it constitutes an advantage, and argue it is not sufficient. Secondly, if an advantage does exist, it needs to be demonstrated it (...) is unfair. We argue the advantage would not be unfair because to say otherwise relies on a presupposition about whether these athletes are female, which involves contradictory and inconsistent definitions of sex. Thirdly, we contend that even if it is established that there is an advantage and it is unfair, the response of requiring athletes to take testosterone-suppressing medication is not appropriate and is unfair. (shrink)

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of (...) identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies. (shrink)

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the case at (...) the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used. (shrink)

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: the data protection regime which follows the application of the European Union General Data Protection Regulation, and the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore (...) has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper. (shrink)