Emerging biotechnologies: full report - Nuffield Council on Bioethics
Emerging biotechnologies: full report - Nuffield Council on Bioethics
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<br />
Biosafety and biosecurity<br />
8.4 A particularly influential set of c<strong>on</strong>cerns for the regulati<strong>on</strong> of emerging <str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g> has been<br />
physical and envir<strong>on</strong>mental harm described under the rubrics of ‘biosafety’ and ‘biosecurity’. Of<br />
course, biosafety and biosecurity are not at all unique to emerging <str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g> but they<br />
arise with particular force here because of the key characteristics of emerging <str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g>:<br />
the way uncertainty, ambiguity and transformative potential simultaneously produce a culture of<br />
high expectati<strong>on</strong>s about benefits and high trepidati<strong>on</strong> about harms, and where there are<br />
profound difficulties in predicting – or, indeed, identifying – either.<br />
C H A P T E R 8<br />
8.5 While the terms ‘biosafety’ and ‘biosecurity’ have no universally accepted definiti<strong>on</strong> and their<br />
meaning varies c<strong>on</strong>textually, 563 they can be understood in the following ways:<br />
■ Biosafety relates to “the safe handling and c<strong>on</strong>tainment of infectious microorganisms and<br />
hazardous biological materials”, 564 applicable to humans, animals and the envir<strong>on</strong>ment.<br />
■ Biosecurity relates to securing biological materials in the c<strong>on</strong>text of military and nati<strong>on</strong>al<br />
security risks, for example in relati<strong>on</strong> to biological warfare or biological terrorism. More<br />
generally, biosecurity can be understood as “the protecti<strong>on</strong> of living organisms from harmful<br />
effects brought about by other species, especially the transmissi<strong>on</strong> of disease”. 565<br />
8.6 As a shorthand biosafety is sometimes thought of as being c<strong>on</strong>cerned with keeping hazardous<br />
biological materials away from people and biosecurity as being c<strong>on</strong>cerned with keeping people<br />
away from hazardous biological materials. 566 Biotechnologies present obvious biosafety issues<br />
given that they are intended to affect biological systems and some of these systems are capable<br />
of experiencing harm, either directly or indirectly. 567 However, what makes these issues<br />
particularly difficult to manage is the potential absence of a predictable, linear correlati<strong>on</strong><br />
between interventi<strong>on</strong> and effect, and the uncertainty of the benefit or harm that might accrue.<br />
This is compounded as the combined effect of the special characteristics of emerging<br />
<str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g> simultaneously create difficulties in anticipating the effect of possible regulatory<br />
designs or decisi<strong>on</strong>s (‘locking in’ or ‘crowding out’ a technology, for example).<br />
http://www.hfea.gov.uk/docs/Warnock_Report_of_the_Committee_of_Inquiry_into_Human_Fertilisati<strong>on</strong>_and_Embryology_1<br />
984.pdf) and in Europe Case C-34/10 Brüstle v Greenpeace eV (CJEU 18 October 2011), available at:<br />
http://curia.europa.eu/juris/liste.jsf?language=en&num=C-34/10#).<br />
563 For example, biosecurity could be understood as a subset of biosafety: a procedure designed to limit the possibly of<br />
pathogens being acquired for criminal purposes could be easily understood as part of basic laboratory biosafety measures<br />
for the c<strong>on</strong>tainment of hazardous material. In turn, biosecurity has been described as becoming “the master frame for<br />
debates about threats to human, animal, and plant-based ecologies and the policies and practices developed to anticipate<br />
and mitigate risk.” Maye D, Dibden J, Higgins V and Potter C (2012) Governing biosecurity in a neoliberal world: comparative<br />
perspectives from Australia and the United Kingdom Envir<strong>on</strong>ment and Planning A 44: 150.<br />
564 Department of Health and Human Services, Centers for Disease C<strong>on</strong>trol and Preventi<strong>on</strong> and Nati<strong>on</strong>al Institutes of Health<br />
(2009) Biosafety in microbiological and biomedical laboratories: 5th editi<strong>on</strong>, available at:<br />
http://www.cdc.gov/biosafety/publicati<strong>on</strong>s/bmbl5/BMBL.pdf, p1.<br />
565 Lackie J (Editor) (2007) Chambers dicti<strong>on</strong>ary of science and technology (Edinburgh: Chambers), p123. However, there is no<br />
single accepted definiti<strong>on</strong> of the term (see: Health and Safety Executive (2007) Final <str<strong>on</strong>g>report</str<strong>on</strong>g> <strong>on</strong> potential breaches of<br />
biosecurity at the Pirbright site 2007, available at: http://www.hse.gov.uk/news/archive/07aug/final<str<strong>on</strong>g>report</str<strong>on</strong>g>.pdf, p10). However,<br />
it may be taken to imply both the “c<strong>on</strong>tainment of ideas and informati<strong>on</strong> as well as bioagents” (Sture JF (2010) Dual use<br />
awareness and applied research ethics: a brief introducti<strong>on</strong> to a social resp<strong>on</strong>sibility perspective for scientists, available at:<br />
http://www.brad.ac.uk/bioethics/media/SSIS/<strong>Bioethics</strong>/docs/Dual_Use_and_Soc_Resp_Guidance_FINAL.pdf) as is the case,<br />
for example, with knowledge c<strong>on</strong>cerning the synthesis of pathogens. See: Herfst S, Osterhaus ADME and Fouchier RAM<br />
(2012) The future of research and publicati<strong>on</strong> <strong>on</strong> altered H5N1 viruses Journal of Infectious Diseases 205: 1628-31.<br />
566 Sture JF (2010) Dual use awareness and applied research ethics: a brief introducti<strong>on</strong> to a social resp<strong>on</strong>sibility perspective for<br />
scientists, available at:<br />
http://www.brad.ac.uk/bioethics/media/SSIS/<strong>Bioethics</strong>/docs/Dual_Use_and_Soc_Resp_Guidance_FINAL.pdf, p7.<br />
567 The objective of the Cartagena Protocol <strong>on</strong> Biosafety is to ensure an “adequate level of protecti<strong>on</strong> in the field of the safe<br />
transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects<br />
<strong>on</strong> the c<strong>on</strong>servati<strong>on</strong> and sustainable use of biological diversity…” (Article 1). United Nati<strong>on</strong>s (2000) Text of the Cartagena<br />
Protocol <strong>on</strong> Biosafety to the C<strong>on</strong>venti<strong>on</strong> <strong>on</strong> Biological Diversity, available at:<br />
http://treaties.un.org/doc/Treaties/2000/01/20000129%2008-44%20PM/Ch_XXVII_08_ap.pdf.<br />
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