Emerging biotechnologies: full report - Nuffield Council on Bioethics

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E m e r g i n g b i o t e c h n o l o g i e s 8.7 An example of such a risk-based regulatory system can befound in the European framework for the contained use and deliberate release of genetically modified organisms (GMOs). 568 It is based primarily on risk assessment procedures relating to physical harm. Both contained use and deliberate release require specific assessment procedures to be followed before authorisation is given: 569 ■ An assessment of contained uses should take into account issues including disease to humans, animals and plants; and deleterious effects due to the impossibility of treating (or providing a prophylaxis for) a disease. The relevant European Directive notes that “[t]he first stage in the assessment process should be to identify the harmful properties of the recipient and, where appropriate, the donor micro-organism, and any harmful properties associated with the vector or inserted material, including any alteration in the recipient’s existing properties.” 570 ■ An environmental risk assessment for deliberate release has the objective of identifying and evaluating “potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment”. 571 8.8 The ‘scientific’ nature of risk assessments in this area are often emphasised. For example, the UK Department for Environment, Food and Rural Affairs (Defra) notes that “[u]nder European Union (EU) legislation, GMOs, including genetically modified crops, can only be released into the environment if a science-based risk assessment shows that safety will not be compromised”; 572 the European Food Safety Authority states (EFSA) “[g]enetically modified (GM) foods can only be authorised in the European Union if they have passed a rigorous safety assessment”. 573 Although EFSA does not actually authorise GMOs – this is done by the European Commission – it does provide what it describes as “scientific advice” through the GMO Working Panel, which is comprised of “independent scientific experts” who release assessments based on “scientific dossiers”. 574 The ‘dual use’ problem 8.9 The term ‘dual use’ is intricately linked with the issue of biosecurity and is applied to the tangible and intangible features of a technology that enable it to be applied to both hostile and peaceful ends with no, or only minor, modifications. 575 The US National Science Advisory Board for Biosecurity (NSABB) 576 describes dual-use research that raises concern as “research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or materiel.” 577 8.10 To some extent, all technologies (for example, metallurgy, explosives, electronics, and nuclear energy) have been used for hostile purposes. 578 However, some have argued that modern biomedical research is ‘dual use’ in a way that is not the case with regard to, for example, 568 ‘Contained use’ generally refers to work in research laboratories while ‘deliberate release’ refers to activities such as placing a product on the market. 569 Article 6(2) Directive 90/219/EEC on the contained use of genetically modified micro-organisms and Article 4(2) 2001/18/EC on the deliberate release into the environment of genetically modified organisms, respectively. 570 Annex III, Directive 2009/41/EC on the contained use of genetically modified micro-organisms (recast). 571 Annex II, Directive 2001/18/EC. 572 Defra (2012) Genetic modification (GM), available at: http://www.defra.gov.uk/environment/quality/gm. 573 European Food Standards Agency (2012) Genetically modified organisms, available at: http://www.efsa.europa.eu/en/topics/topic/gmo.htm. 574 Ibid. 575 McLeish C and Nightingale P (2005) Strengthening the Biological Weapons Convention briefing paper No 17 (second series) – effective action to strengthen the BTWC regime: the impact of dual use controls on UK science, available at: http://www.sussex.ac.uk/Units/spru/hsp/documents/Mcleish%20pubs%20BP_17_2ndseries.pdf, p4. 576 The NSABB is a US “federal advisory committee chartered to provide advice, guidance, and leadership regarding biosecurity oversight of dual use research”. See: National Institutes of Health (2012) About NSABB, available at: http://oba.od.nih.gov/biosecurity/about_nsabb.html. 577 National Institutes of Health (2012) Dual use research and dual use research of concern, available at: http://oba.od.nih.gov/biosecurity/nsabb_faq.html#NSABB_FAQ002. 578 Meselson M (2000) Averting the hostile exploitation of biotechnology The CBW Conventions Bulletin 48: 16-9, p16. 138
E m e r g i n g b i o t e c h n o l o g i e s nuclear materials technology, insofar as the “underlying research and technology base is available to a rapidly growing and increasingly international technical community”. 579 For example, “pathogens listed by the Government as potential agents for terrorists are used in thousands of clinical and diagnostic laboratories.” 580 8.11 Regulatory decisions made around biosecurity and dual-use research touch on a number of areas: health, security, academic freedom, international trade and scientific and technological development. A commonly discussed biosecurity concern is the possibility of limiting research on the creation of particular pathogens from scratch, or work on increasing virulence in an attempt to reduce the likelihood of the information being used by hostile non-state actors or rival states. For example, NSABB recommended in 2011 that experimental evidence relating to a highly pathogenic avian influenza virus subtype acquiring the ability to transmit via aerosols between ferrets should not be published. 581 In 2012, NSABB concluded that knowledge generated by the research “could conceivably be directly misused to threaten public health or national security.” 582 There are significant uncertainties on both sides in such decisions: the likely threat to national or global security is hard to quantify and the longer range health benefits of relatively early stage research are difficult to gauge. C H A P T E R 8 Relevance to issues concerning emerging biotechnology 8.12 There are distinctive approaches in the regulation of <strong>biotechnologies</strong> (and applied biotechnology research) depending on whether their context of application is medical or non-medical, and whether their primary perceived effect is on human health or on the environment. What is more important than technical risk assessment in relation to emerging <strong>biotechnologies</strong> is to explore the meaning of the risks and levels of uncertainty. For example, there were, and remain, considerable ambiguities associated with the implementation of GM technologies, especially in relation to food crops: technically accurate risk assessments relating to acceptable levels of cross-contamination between GM and non-GM crops, or the likelihood or physical harm to human recipients of the resulting food, fail to take adequate account of the level of polarisation in societal attitudes to the technology. As a result, many conflicting – sometimes irreconcilable – value judgments applied by different parts of society are simply excluded from the formal regulatory procedures for decision making. Such exclusions can ultimately destabilise the expected technological pathway for which regulation is designed. Whether or not they do so may depend partly on how the different framings are established in society and on how judgments are amplified in the social discourse surrounding the technology. (For example, social opposition to GM crops and foods was effectively amplified; principled opposition to human embryo research has remained marginal.) 8.13 The (non-)introduction of GM crops into the UK is often highlighted as an example of a failure to commercialise a new technology. Much has been said in relation to synthetic biology and nanotechnology in terms of how to avoid the ‘pitfalls’ encountered by those who went though the same process with GM crops in the late 1990s and early 2000s. 583 To some extent, these issues could have been avoided (which does not necessarily mean a different outcome would have resulted) if there had been a more sophisticated appreciation of the complex nature of the uncertainties and ambiguities associated with the technology: simply noting the safety of a technology within particular defined boundaries does not necessarily address the concerns of those objecting to its introduction if there is a fundamental disagreement about the significance 579 Stern J (2002/3) Dreaded risks and the control of biological weapons International Security 27: 89-123. 580 Ibid, p95. 581 Herfst S, Osterhaus ADME and Fouchier RAM (2012) The future of research and publication on altered H5N1 viruses Journal of Infectious Diseases 205: 1628-31. See also Box 3.1. 582 National Science Advisory Board for Biosecurity (2012) Findings and recommendations: March 29-30, 2012, available at: http://oba.od.nih.gov/oba/biosecurity/PDF/03302012_NSABB_Recommendations.pdf, p5. 583 See, for example: Sciencewise (2011) Listening or explaining? Avoiding a deficit approach to public engagement in synthetic biology, available at: http://www.sciencewise-erc.org.uk/cms/listening-or-explaining-avoiding-a-deficit-approach-to-publicengagement-in-synthetic-biology. 139
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Emerging b
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Emerging b
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Secretariat Hugh Whittall (Director
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Foreword 1 The use of living organi
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Terms of reference 1. To examine co
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Applying public ethics: towards a p
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E m e r g i n g b i o t e c h n o l
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Part 1 Understanding emerging <stro
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Chapter 2 Biotechnology promises an
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Chapter 3 The threefold challenge o
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Chapter 5 Public perspectives
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