The US’ Food and Drug Administration, Normativity of Risk Assessment, GMOs, and American Democracy

The process of risk assessment of biotechnologies, such as genetically modified organisms (GMOs), has normative dimensions. However, the US’ Food and Drug Administration (FDA) seems committed to the idea that such evaluations are objective. This essay makes the case that the agency’s regulatory approach should be changed such that the public is involved in deciding any ethical or social questions that might arise during risk assessment of GMOs. It is argued that, in the US, neither aggregative nor deliberative (representative) democracy ought to be used to make such determinations. Instead, participatory (deliberative) democracy should be the means by which members of the polity decide which normative concerns ought to underlie FDA’s assessment of GMOs. This paper uses a hypothetical case involving a new GM seed to make that argument.     

Ethics in the Societal Debate on Genetically Modified Organisms: A (Re)Quest for Sense and Sensibility

Via a historical reconstruction, this paper primarily demonstrates how the societal debate on genetically modified organisms (GMOs) gradually extended in terms of actors involved and concerns reflected. It is argued that the implementation of recombinant DNA technology out of the laboratory and into civil society entailed a “complex of concerns.” In this complex, distinctions between environmental, agricultural, socio-economic, and ethical issues proved to be blurred. This fueled the confusion between the wider debate on genetic modification and the risk assessment of transgenic crops in the European Union. In this paper, the lasting skeptical and/or ambivalent attitude of Europeans towards agro-food biotechnology is interpreted as signaling an ongoing social request – and even a quest – for an evaluation of biotechnology with Sense and Sensibility. In this (re)quest, a broader-than-scientific dimension is sought for that allows addressing the GMO debate in a more “sensible” way, whilst making “sense” of the different stances taken in it. Here, the restyling of the European regulatory frame on transgenic agro-food products and of science communication models are discussed and taken to be indicative of the (re)quest to move from a merely scientific evaluation and risk-based policy towards a socially more robust evaluation that takes the “non-scientific” concerns at stake in the GMO debate seriously.     

GMOs and Global Justice: Applying Global Justice Theory to the Case of Genetically Modified Crops and Food

Proponents of using genetically modified (GM) crops and food in the developing world often claim that it is unjust not to use GMOs (genetically modified organisms) to alleviate hunger and malnutrition in developing countries. In reply, the critics of GMOs claim that while GMOs may be useful as a technological means to increase yields and crop quality, stable and efficient institutions are required in order to provide the benefits from GMO technology. In this debate, the GMO proponents tend to rely on a simple utilitarian type of calculus that highlights the benefits of GMOs to the poor, but that overlooks the complex institutional requirements necessary for GMO production. The critics, recognizing the importance of institutional conditions, focus primarily on the negative impacts of institutional deficiencies, thereby overlooking the basically Rawlsian claim that institutions per se may generate claims to justice. This article investigates how GMOs might generate claims to global justice and what type of justice is involved. The paper argues that the debate on GMOs and global justice can be categorized into three views, i.e., the cosmopolitan, the pluralist, and the sceptic. The cosmopolitan holds that GMOs can and should be used for alleviating global hunger, whereas the sceptic rejects this course of action. I will argue here for a moderately cosmopolitan approach, relying on the pluralist view of institutions and the need to exploit the benefits of GMOs. This argument rests on the premise that global cooperation on GMO production provides the relevant basis for assessing the use of GMOs by the standard of global distributive justice.     

Coexistence of Plants and Coexistence of Farmers: Is an Individual Choice Possible?

The introduction of genetically modified organisms (GMOs) in Europe has been characterized by controversy. In 2002, the European Union introduced the concept of “coexistence” as a compromise solution that, through the establishment of science-based technical measures, should allow the market to operate freely while reducing policy conflicts on GMOs. However, the concept remains highly contested and the technical measures difficult to apply. This paper presents qualitative research on the conceptualization and implementation of the coexistence framework in two regions of Spain (Catalonia and Aragon), where 42% and 55% of maize was GM in 2006, respectively. In this context, the concept of coexistence and its proposed implementation both fail to resolve previous conflicts and actually work to generate new ones through the individualization of choice and impacts. Considerations of the social conditions in which the technology and the management measures are implemented were not taken into account. This resulted in the promotion of biotechnological agriculture over other alternatives.     

The Magic Bullet Criticism of Agricultural Biotechnology

One common method of criticizing genetically modified organisms (GMOs) is to label them as “magic bullets.” However, this criticism, like many in the debate over GMOs, is not very clear. What exactly is the “magic bullet criticism”? What are its origins? What flaw is it pointing out in GM crops and agricultural biotechnology? What is the scope of the criticism? Does it apply to all GMOs, or just some? Does it point to a fatal flaw, or something that can be fixed? The goal of this paper is to answer these questions and clarify the magic bullet criticism of agricultural biotechnology. It is hoped that the results of this exercise will be helpful in advancing deliberation over the role GMOs and agricultural biotechnology should play in 21st century agriculture.     

A Study of How Experts and Non-Experts Make Decisions on Releasing Genetically Modified Plants

The introduction of genetically modified plants into the environment has been marked by different positions, either in favor of or against their release. However, the problem goes well beyond such contradictory positions; it is necessary to take into account the legislation, ethics, biosafety, and the environment in the considerations related to the release of genetically modified organisms (GMOs). To this end, the Brazilian Committee of Biosafety (CTNBio), a consultative and deliberative multidisciplinary collegiate, provides technical and advisory support to the Brazilian Federal Government. This committee consists of scientists and non-scientists who participate in evaluating the dossiers of companies that are requesting approval by the Brazilian Government; consequently, the aim of this study was to investigate whether commercial approvals of GMOs were associated with the profile of the CTNBio members. Research was based on the minutes taken at CTNBio meetings carried out from 2006 up to 2009, considering law 11.105/2005 and the Constitution of 1988 as legal frameworks, to determine the number of voters in favor of or against releasing genetically modified Bt-maize, Bt-cotton, and herbicide resistant soybeans to be used in Brazilian agriculture. Via the internet, we had access to the curriculum vitae of the CTNBio members through the Plataforma Lattes database of the National Council for Scientific and Technological Development (CNPq), where we found their area of expertise. CTNBio members were divided into expert-for, expert-against, non-expert-for, and non-expert-against. Results showed that CTNBio decisions could be based on technical criteria as well as on the policy of the institution that expert-members were representing.     

A Precautionary Approach to Genetically Modified Organisms: Challenges and Implications for Policy and Science

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.     

The Precautionary Principle: Scientific Uncertainty and Omitted Research in the Context of GMO Use and Release

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.     

Risks Associated with Genetic Modification: – An Annotated Bibliography of Peer Reviewed Natural Science Publications

We present an annotated bibliography of peer reviewed scientific research highlighting the human health, animal welfare, and environmental risks associated with genetic modification. Risks associated with the expression of the transgenic material include concerns over resistance and non-target effects of crops expressing Bt toxins, consequences of herbicide use associated with genetically modified herbicide-tolerant plants, and transfer of gene expression from genetically modified crops through vertical and horizontal gene transfer. These risks are not connected to the technique of genetic modification as such, but would be present for any conventionally produced crops with the same heritable traits. In contrast, other risks are a direct consequence of the method used in gene manipulation. These come about because of the unstable nature of the transgene and vectors used to insert it, and because of unpredictable interactions between the transgene and the host genome. The debate over the release of genetically modified organisms is not merely a scientific one; it encompasses economics, law, ethics, and policy. Any discussion on these levels does, however, need to be informed by sound science. We hope that the scientific references provided here will provide a useful starting point for further debate.     

Sustainable Development and Norwegian Genetic Engineering Regulations: Applications, Impacts, and Challenges

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.     

Assessment of GM Crops in Commercial Agriculture

The caliber of recent discourse regarding geneticallymodified organisms (GMOs) has suffered from a lack of consensuson terminology, from the scarcity of evidence upon which toassess risk to health and to the environment, and from valuedifferences between proponents and opponents of GMOs. Towardsaddressing these issues, we present the thesis that GM should bedefined as the forcible insertion of DNA into a host genome,irrespective of the source of the DNA, and exclusive ofconventional or mutation breeding.Some defenders of the commercial use of GMOs have referred to thescientific work of GMO critics as ``junk science.' Such a claim isfalse and misleading, given that many papers critical of both theutility and safety of GMOs have been published in peer reviewedjournals by respected scientists. In contrast, there is a dearthof peer reviewed work to substantiate the frequently heardassertions of either safety or utility in GMOs. The polarity,which now characterizes much of the public discourse on GMOs,reflects not simply scientific disagreement, but alsodisagreement in underlying value assumptions. Value differencesstrongly affect the assessment of both benefit and harm fromGMOs.The concept of substantial equivalence occupies a pivotalposition in the GMO risk assessment process that is used in bothCanada and the US. A GMO judged to be substantially equivalent toa conventional product – as have all submissions to date – ispresumed to be safe enough for commercialization. The conclusionof safety – from both human health and environmental perspectives– should be based on scientific evidence, corroborated by actualexperimentation. However, regulators infer safety largely fromassumptions-based reasoning, with little or no experimentalvalidation. The judgement of safety because of substantialequivalence is a dubious argument by analogy.     

Science and values in risk assessment: The case of deliberate release of genetically engineered organisms

To make more responsible decisions regarding risk and to understand disagreements and controversies in risk assessments, it is important to know how and where values are infused into risk assessment and how they are embedded in the conclusions. In this article an attempt is made to disentangle the relationship of science and values in decision-making concerning the deliberate release of genetically modified organisms (GMOs) into the environment. This exercise in applied philosophy of science is based on Helen Longino's contextual empiricism which attempts to reconcile the objectivity of science with its social and cultural construction. Longino distinguishes different levels of research on which values apparently contextual with respect to a given research program can shape the knowledge emerging from that program. Her scheme is applied for locating and identifying the values that affect environment risk assessments of the field experiments with GMOs. The article concludes with some provisional suggestions for the decision process and the role of scientists in it.     

Ethics of Sustainable Development – a Study of Swedish Regulations for Genetically Modified Organisms

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.     

Global Trade in GM Food and the Cartagena Protocol on Biosafety: Consequences for China

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.     

Biosafety Act 2007: Does It Really Protect Bioethical Issues Relating To GMOS

Despite the (serious) global concerns about the safety and genetic stability of genetically modified organisms, the Malaysian National Biosafety Board (NBB) has recently approved the field testing for genetically modified (GM) male mosquitoes. With this development, bioethical issues, which in some respect could adversely impinge on the social, economic and environmental aspects of the society, have surfaced, and these concerns must be addressed by the authorities concerned. In reviewing this application, the National Biosafety Board has followed the requirements of the Biosafety Act 2007, which was created to strike a balance between promoting biotechnology and at the same time protecting against its potential environmental and human health risks in Malaysia. However, the 2007 Act fails to adequately take into account any bioethical issues in spite of the inclusion of a provision on socio-economic consideration. As part of an ongoing doctoral research project, and by way of an instrumental critique of the 2007 Act, the present paper attempts to address the role and function of the Malaysia biosafety legal framework in governing bioethical concerns relating to Genetically Modified Organisms (GMOs) within the current biotechnology background in Malaysia. Additionally, the paper suggests that the ambiguity of the provisions contained within the 2007 Act in governing such concerns, representing wider societal interests and welfare, in some ways might defeat the balancing role that this act was originally intended to fulfil.     

“The Moral Difference between Intragenic and Transgenic Modification of Plants”

Public policy on the development and use of genetically modified organisms (GMOs) has mainly been concerned with defining proper strategies of risk management. However, surveys and focus group interviews show that although lay people are concerned with risks, they also emphasize that genetic modification is ethically questionable in itself. Many people feel that this technology “tampers with nature” in an unacceptable manner. This is often identified as an objection to the crossing of species borders in producing transgenic organisms. Most scientists reject these opinions as based on insufficient knowledge about biotechnology, the concept of species, and nature in general. Some recent projects of genetic modification aim to accommodate the above mentioned concerns by altering the expression of endogenous genes rather than introducing genes from other species. There can be good scientific reasons for this approach, in addition to strategic reasons related to greater public acceptability. But are there also moral reasons for choosing intragenic rather than transgenic modification? I suggest three interrelated moral reasons for giving priority to intragenic modification. First, we should respect the opinions of lay people even when their view is contrary to scientific consensus; they express an alternative world-view, not scientific ignorance. Second, staying within species borders by strengthening endogenous traits reduces the risks and scientific uncertainty. Third, we should show respect for nature as a complex system of laws and interconnections that we cannot fully control. The main moral reason for intragenic modification, in our view, is the need to respect the “otherness” of nature.     

Onsite Sewage System Regulation Along the Great Lakes and the US EPA “Homeowner Awareness” Model

According to the United States Environmental Protection Agency (US EPA), a significant percentage of residential onsite sewage systems (OSSs) are failing at any given time. The US EPA has therefore issued a set of recommended guidelines for OSS regulatory programs aimed at reducing overall failure rates. We conducted a survey of OSS regulatory program administrators with jurisdictions bordering a Great Lake. Our goal was to determine their programs’ capacities to meet the US EPA’s recommendations. We found that although some local programs meet the US EPA’s recommendations, most do not. In this article, we present our findings and conclusions for one of the US EPA’s models, the baseline “Homeowner Awareness” model. Most areas do not have recommended requirements that systems be inspected when properties transfer between owners. A majority do not track changes in ownership within the computerized databases they use to record information about systems. Although most provide at least “one-time” information to homeowners regarding proper OSS maintenance, most do not contact them periodically with reminders of needed maintenance. We include recommendations for resolving some of the issues that our research identified.     

The Moral Considerability of Invasive Transgenic Animals

The term moral considerability refers to the question of whether a being or set of beings is worthy of moral consideration. Moral considerability is most readily afforded to those beings that demonstrate the clearest relationship to rational humans, though many have also argued for and against the moral considerability of species, ecosystems, and “lesser” animals. Among these arguments there are at least two positions: “environmentalist” positions that tend to emphasize the systemic relations between species, and “liberationist” positions that tend to emphasize the attributes or welfare of a particular individual organism. Already, this classic conflict provides for some challenging theoretical clashes between environmentalists and animal liberationists. The question of moral considerability is complicated, however, by recent developments in genetic engineering. Some animals, like pigs and fish, have been genetically modified by humans to grow organs that can then be transplanted into humans. If environmental arguments for the moral consideration of species are correct, then we are released from our obligations to morally consider those animals that we have genetically modified, since they are by their nature always an “invader species.” If, instead, the welfare of the animal is of penultimate importance, then there is a case for strengthening the moral considerability of GM animals over “naturally-occurring” animals, since they bear a closer relationship to humans. This would appear to be an intractable problem, a “bad marriage,” as Mark Sagoff once proposed. This paper argues that the case of invasive transgenic animals exposes weaknesses in this classic conflict, and particularly, in the framing of this conflict. To remedy this framing problem, this paper argues for a reconceptualization of the term “moral considerability,” instead urging a strong distinction between moral considerability, moral relevance, and moral significance.     

Risk assessment methodologies for biotechnology impact assessment

Summary By combining hazard assessment of effects of a potential biotechnology product with exposure assessments based on study of the genetically engineered organism's fate, conclusions may be reached about the risk involved in release of the product to the environment. In order to make this risk assessment, criteria (including regulatory endpoints) must be established and then developed further against a data base from well-accepted tests. Other aspects requiring research and development include test evaluation, quality assurance, statistical procedures, and methods of identifying and monitoring not only the nominal organism(s) in the products, but also any contaminating material or organisms to which the genetically engineered components may be transferred in the environment.Application of microcosm technology to testing of genetically engineered organisms is expected to be important, since these systems may be used safely to understand fate and effects prior to (or in place of) testing the product in the environment. Limitations in the use of microcosms may be offset by the cost-effectiveness and incisiveness of results, as has been shown for other pollutants.Risk management for biotechnology products currently lacks an adequate background, but components of the process exist or can be developed. New resources, in terms of personnel, training, facilities, and funding, will be needed in order to apply the risk assessment paradigm used for toxic chemicals and pesticides. We will need to know:     

The transatlantic rift in genetically modified food policy

The regulatory structures underlying United States and European Union policies regarding genetically modified (GM) food and crops are fundamentally different. The US regulates GM foods and crops as end products, applying roughly the same regulatory framework that it does to non GM foods or crops. The EU, on the other hand, regulates products of agricultural biotechnology as the result of a specific production process. Accordingly, it has developed a network of rules that regulate GM foods and crops specifically. As a result, US regulation of GM foods and crops is relatively permissive, whereas EU regulation is relatively restrictive. Why are genetically modified food policies in the United States and the European Union so strikingly different? In the light of the recent World Trade Organization dispute on agricultural biotechnology, it may seem that economic interests are the driving force behind policies. While they are certainly part of the picture, the issue is far more complex. This paper argues that three different elements help explain differences between US and EU GM food policies. First, an investigation of US and European policies of the 1970s and 1980s on recombinant DNA research and of events leading up to early GM food and crop regulation allows a deeper understanding of current policy. Second, scrutinizing underlying values and norms can uncover the beliefs that condition current GM food and crop policy. Third, an analysis of involved actors’ views and levels of success in influencing policy is essential to understanding US and EU policies.