Showing posts with label De-extinction. Show all posts
Showing posts with label De-extinction. Show all posts

09 October 2020

Mammoths

'Patentability and de-extinct animals in Europe: the patented woolly mammoth?' by Aisling McMahon and David M Doyle in (2020) Journal of Law and the Biosciences comments 

De-extinction is a hot topic within conservation science but the potential patentability of de-extinct animals in Europe has hitherto been unexplored. This article addresses this lacuna, examining the legal, commercial, and ethical implications of patenting de-extinct animals under European patent law. The article is organized into four parts. Part I explores the reasons why patents are relevant and may be applied for in this context. Part II provides an overview of the scientific techniques currently being used in de-extinction projects, setting the foundation for the analysis of patentability which follows. Part III then critically assesses whether recreated animals would qualify as patent eligible subject matter under European patent law. It also investigates the extent to which European patent exclusions such as those on animal varieties, essentially biological processes, and the morality provisions might apply and whether recreated animals would meet the novelty requirement for patentability. Part IV concludes by highlighting the possible ramifications of patenting such animals, elucidating the chasm between the cultural and symbolic significance held by such animals, and their lack of differential treatment in the patent law sphere. It argues that de-extinction reignites questions around the scope of patents, and the role of ethical considerations within patent decision-making which warrant urgent reconsideration. 

 The authors argue 

 Ever since the 1993 blockbuster film ‘Jurassic Park,’ the notion of bringing vanished species back to life has hovered on the boundaries of reality and science fiction, but scientists are now reputedly on the brink of de-extinction. While conservationists argue that this risks persuading lay people that extinction is reversible, technological advances in synthetic biology and genetics have made the revival of extinct species a real scientific possibility, with much of the recent literature in this area shifting from whether we can resurrect extinct species to whether we should. In May 2016, for instance, the International Union for the Conservation of Nature Species Survival Commission released ‘Guiding Principles for Creating Proxies of Extinct Species for Conservation Benefit’ (2016), while scientists, conservationists and bioethicists, inter alia, have begun to consider the ethics of reviving extinct species, the optimal candidate species for de-extinction, as well as attempting to conduct cost-benefit analyses of both resurrection and reintroduction. The ‘nascent discipline’ of de-extinction has been the topic of animated debates within the scientific community,5 but at least one point of consensus has emerged: we are now on the brink of de-extinction. As Donlan puts it, ‘[t] here are many unknowns surrounding de-extinction. Whether it will happen or not, however, is likely not to be one of them.’ 

Much of the academic literature to date has understandably focused on the science of bringing back extinct species, but ‘de-extinction presents us with myriad ethical, legal and regulatory questions.’ These include a range of questions around the legal status of de-extinct animals, including potential legal obligations to protect them, and the resulting environmental issues which may arise. Moreover, an important but underexplored question is the extent to which such animals, if successfully recreated, could be commercialized. Watching certain resurrected species, especially ‘cool’ and ‘charismatic megafauna,’ is expected to be an exciting diversion for many (indeed, it is often considered, albeit anecdotally, to be a central motivation for de-extinction), but little academic work has focused on the ‘non-ecological “instrumental values” that de-extinct species would be likely to have for human beings, most notably, their commercial value.’ One avenue to obtain such value from de-extinct animals is via the patent system, and specifically applying for a patent on the revived animal, yet it remains an open question whether such animals would be patentable in the European context, if ongoing de-extinction attempts are successful. In taking this focus, the article explores the legal, commercial, and ethical implications of ‘patenting’ de-extinct animal species. 

This article breaks new ground by exploring the potential European patent law implications of de-extinction in relation to animal life. In doing so, this paper focuses on animal life, as opposed to plant or other organisms, which could also be recreated via de-extinction. The rationale underlying this approach is rooted in the fact that it is these projects (e.g. particularly the Woolly Mammoth project) that have captured the public imagination and provoked the most scholarly concern to date. For this reason, we wish to explore how applications for patents on such animals in Europe may play out if such megafauna are successfully recreated. 

In examining this issue, the article focuses on the European patent law context for two main reasons: first, to date, academic inquiries of the legal implications of de-extinction have focused almost exclusively on domestic law in the USA. This is not to suggest that these studies are less valuable for adopting such an approach—the USA, after all, is one of the traditional centers of conservation power and where key de-extinction projects are ongoing but many of the species that are considered viable candidates for some form of de-extinction are not species whose habitats or migration routes are exclusive to, or even include, the USA. The applicable laws outside the US context are in vital need of investigation if we are to preemptively address the legal issues that could conceivably arise should de-extinction become feasible in the next few years. To date, these aspects of species recreation and particularly the patent implications in Europe have remained unexplored. This article aims to address this lacuna by furnishing a detailed analysis of de-extinction under European patent law. 

Secondly, the focus on European patent law was taken because Europe is one of the few patent jurisdictions with express moral exclusions from patentability. Therefore, examining the European context provides a useful site to examine the ethical ramifications of granting patents in the de-extinction context and the extent to which such ethical issues are likely to be considered within patent law. It explores how the current exclusions under European law—which have proved so controversial in the past for transgenic animals—could potentially be interpreted in the de-extinction context. Given that European patent law has express moral exclusions from patentability, concerns posed by patents on de-extinct animals could theoretically (at least on paper) have a greater chance of consideration within the European context. However, the article will argue that given past interpretative practices surrounding such provisions in Europe, without institutional change within patent law, such ethical considerations are unlikely to be significant hurdles to patenting such technology in Europe (contingent, of course, on how the science develops). 

This analysis has important practical and theoretical significance. From a practical perspective, the article highlights the main patentability questions within European law that will arise in light of de-extinction projects, aiming to provide an important reference point within the de-extinction debate. At a theoretical level, it identifies aspects of European biotechnological patent law that will require further clarification should de-extinction come to fruition, such as definitional questions surrounding the patentability of cloned animals and transgenic animals not created for medical research purposes. As will be demonstrated, these issues also have broader significance for advanced biotechnologies more generally. 

In conducting this analysis, the article is structured as follows: Part I demonstrates why patents are relevant and could be applied for in the context of de-extinction projects; Part II then briefly maps the scientific avenues that are being used in de-extinction projects setting the foundation for the legal analysis which follows; Part III provides a detailed assessment of the potential patentability of de-extinct animals, examining questions of patent eligible subject matter; the potential applications of the exclusions from patentability under Art 53 EPC to animals created in the de-extinction context; and whether such animals would meet the patent novelty requirement. Part IV concludes by highlighting the possible effects, and positive/negative ramifications, of patenting such animals and elucidates the chasm between the cultural and symbolic significance held by such animals, and their lack of differential treatment in the patent law sphere.

18 September 2020

Anabiosis

Anabiosis and the Liminal Geographies of De/extinction' by Adam Searle in (2020) 12(1) Environmental Humanities 321–345 comments

The spectacle of de-extinction is often forward facing at the interface of science fiction and speculative fact, haunted by extinction’s pasts. Missing from this discourse, however, is a robust theorization of de-extinction in the present. This article presents recent developments in the emergent fields of resurrection biology and liminality to conceptualize the anabiotic (not living nor dead) state of de/extinction. Through two stories, this article explores the epistemological perturbation caused by the suspended animation of genetic material. Contrasting the genomic stories of the bucardo, a now extinct subspecies of Iberian ibex whose genome was preserved before the turn of the millennium, and the woolly mammoth, whose genome is still a work in progress, the author poses questions concerning the existential authenticity of this genomic anabiosis. They serve as archetypal illustrations of salvaged and synthesized anabiotic creatures. De/extinction is presented as a liminal state of being, both living and dead, both fact and fiction, a realm that we have growing access to through the proliferation of synthetic biology and cryopreservation. The article concludes through a presentation of anabiotic geographies, postulating on the changing biocultural significances we attach to organisms both extinct and extant, and considering their implications for the contemporary extinction crisis. 

Searle argues

 Extinction is not a moment or singular event. Extinctions, as ecologically and culturally significant as they may be, are difficult to locate, define, understand, or even imagine. Often the term itself assumes some pre-given contextual meaning that masks its polymorphous ambiguity. Amidst narratives of Anthropocenes, the sixth mass extinction, and the emergence of novel technologies in synthetic biology, both conservation and geographical research face a series of epistemic and ontological questions. The multifaceted nature of extinction invites us to make sense of it empirically, in grounded and relatable “stories,” facilitating and affording the affective reimagining of alternatives and capacities for responses. Amidst an emergent ontology between existential extremes of extinct and extant, scientific speculation and practice are reworking the significances of extinction. This article aims to de-speculate biotechnical assemblages unsettling preceding epistemologies of extinction: contingent on the extinct as permanent and non-negotiable within evolutionary time. This article discusses two nonhuman protagonists at the heart of this emergent ontology: the bucardo, the only extinct animal to have ever been cloned; and the woolly mammoth, perhaps the most charismatic de-extinction candidate. 

The promise of de-extinction radically alters the way we perceive the event of extinction, through an introduced potential for the resurrection of extinct species. Some commentators note that it may inspire agnosticism toward extant animals, whereas others openly celebrate the prospect of optimism in public perceptions of conservation.  De-extinction has been perceived by some as active engagement with the Anthropocene,  symptomatic of the emergent role of technoscience in more-than-human relations, or as an extreme on the spectrum of introductory techniques in the conservationist’s toolbox.  Many scholars in the environmental humanities have demonstrated the multiplicities of extinction. Through an approach inspired by this literature, this article explores the various practices and performances at the interface of biology, technology, and culture in grounding the multiplicities of de-extinction, outlining differences between the bucardo and mammoth de-extinction stories. Taking into account these multiplicities of meaning, defining de-extinction becomes increasingly difficult, especially as one comes up against questions such as: are reintroductions (say, for example, of beavers in Scotland) de-extinctions? However, for ease of argument I follow the typology of Sherkow and Greely in their 2013 Science article, which maintains that de-extinction comes in three forms: back-breeding, cloning, and genetic engineering. 

Back-breeding, the practice of selective breeding in an attempt to reverse domestication, is an interesting approach to ecological restoration for extinct biota currently utilized by some practitioners in the rewilding movement.  This article focuses on the cloning and genetic engineering approaches to de-extinction, due to the use of novel technologies in the genetic governance of life, and their active interactions with the genome. The bucardo and the mammoth are perhaps the classic examples for exploring the practices of speculative science in the global de-extinction discourse. Cloning as a de-extinction tool is contingent on the availability of intact genetic material.  The bucardo is the only extinct mammal to be outlived by their cryopreserved material,  and therefore unique in its resurrection subjection to cloning, yet in an age of salvage cryogenics it is likely the first of many. The mammoth, conversely, is de-extinction’s celebrity candidate. As elaborated by Stephanie Turner, “for extinction narratives, the development of molecular biology means that species such as woolly mammoths and Neanderthals are not lost after all, but continue to exist as genetic codes residing in their remains, codes we are getting better and better at reading and interpreting.”  It is speculatively engaged by synthetic biologists owing to the relative abundance of its genomic material; the rate of biological deterioration diminished through the aid of permafrost. Yet intact cells remain fantastical, and as such a mammoth de-extinction would rely on a process of hybridization with the embryonic material of elephants. 

Entanglements with extinction in both of these cases are archetypal and the most developed, both theoretically and empirically, the justification for their inclusion in this essay. Beyond contrasting techniques, their juxtaposition invites reflection on the changing temporalities and materialities of extinction. Charismatic vertebrates have dominated the global de-extinction discourse, with birds and mammals populating candidate lists disproportionately.  Invertebrates and plants are rarely featured, reflecting the broader allocation of attention in wildlife conservation. Acknowledging that drawing upon these examples may further propagate this oversight, I would emphasize that these two de-extinction stories have been selected for their technoscientific peculiarities rather than the spectacle of the animals themselves. 

This article is not an argument for or against de-extinction, which is a blossoming and encapsulating debate in the ecological and environmental sciences,  bioethics,  law,  genetics,  and even tourism studies.  The list goes on in countless other disciplines, the media, and public imaginations. Phillip Seddon speaks for a significant number of people when he affirms that “de-extinction will be pursued—the reality of the idea is too sexy to ignore, and it could be driven by aesthetic, commercial, scientific, or some other hitherto unanticipated imperatives and motivations.”  As noted by Bill Adams, the prospect of de-extinction has the ability to grab headlines, to circulate and multiply to the extent that it has fallen out of contact with the scientific community.  Consequentially, de-extinction has been subject to intense speculation, and the means in which many come to engage it is at the interface of science fiction and speculative fact.  After calls for a social scientific narrative to de-speculate de-extinction,  this article works toward a theorization of de-extinction’s geographies in the present. I begin by introducing key theoretical aspects of this changing landscape, through which to interrogate the empirical stories of the mammoth and bucardo. These changing epistemologies implicate the geographies and ontologies of extinction. 

De-extinction is a speculative practice engaging the anabiotic: the liminal materiality between living and dead. Liminality is an established tradition in geography, initially conceptualized within the anthropology of ritual,  and is commonly understood as a transitional process between and on both sides of a boundary or threshold. Examples of geographical applications have included identities in cyberspace,  theoretical examinations of borders and diplomatic arenas,  international relations,  and diaspora;  the diversity of its conceptual malleability illustrated in a recent edited book called Breaking the Boundaries: Varieties of Liminality.  “Liminality is also a provocation to take process, creativity, and aspiration seriously.”  Liminality is, itself, a conceptual frame that works through “shaking up epistemological assumptions”  by collapsing binaries around constructed ontological borders, such as extinct/extant, dead/alive, immaterial/material, nonlife/life, and technological/vital. Recent scholarship has applied the concept to animals,  or liminanimals, as Clemens Wischermann and Phillip Howell celebrate the creativity of the hybrid encounter.  Through the stories presented later, I will explore the liminal geographies emerging at the heart of narratives encompassing taxa resurrection, those salvaged and the synthesized genomes in the geographies of de-extinction. De-extinction technologies and ideas unsettle, distort, and disfigure the spaces and temporalities of extinction. This liminal state of de/extinction recalibrates genetics and the genome into a multifaceted existence, being both in potentiality as information and in actuality as deoxyribonucleic acids, exceeding and encompassing the aforementioned dualisms. I use a slash (/) to differentiate this existential liminality from the concept or process of resurrecting extinct taxa that is denoted by hyphenation (-). This discursive function of the slash indicates “an active and reiterative (intra-active) rethinking of the binary,”  allowing the conceptualization of binaries as dynamic and enmeshed rather than strictly oppositional,  as liminal and uncanny. Depending on context, a slash can be used in three ways: to denote “and,” “or,” or the spanning of two discrete categories (e.g. 2011/12). De/extinction should be thought of as a proactive and interactive questioning of the extinction concept, one accounting for both extinction and de-extinction as coexisting actions perpetually rethinking one another, forceful and metamorphic. De/extinction is relative and only makes sense with a contemplation of trace; that is, to consider de-extinction is to consider what extinction is not, and vice-versa.  This ontology exists in a plane of potentiality with agency to shape the ways we engage with and perceive the worlds we inhabit, certainly questioning the notion of extinctions as irreversible and indefinite. 

In what follows this article will explore liminal materialities, two anabiotic existences that unsettle the previously held epistemologies of extinct and extant: the bucardo and the mammoth. Through exploring the materialities and agencies of DNA itself, these genomes distort the discreteness of life and death. Biologists engaging de/extinction optimistically make sense of candidate genomes dissimilarly: they are the salvaged ghosts of extinction’s lost pasts, the synthesized ghosts of extinction’s lost futures. The bucardo and the mammoth provide archetypal illustrations of salvaged and synthesized anabiosis, the “not anymore” and “not there yet.” Genomes are simultaneously material amino acids and immaterial codes of semiotic programming, the program of which is referred to as a text by the molecular biologist, the scriptural model of which Derrida contends is central to advances in postwar science.  “Literary metaphors have been woven into the fabric of molecular biology since its inception. The determination of the human genome sequence has brought these metaphors to the forefront of the popular imagination, with the natural extension of the notion of DNA as language to that of the genome as the ‘book of life.’”  These systems of meaning are appropriately engaged through a posthumanist lens, which “expresses multiple ecologies of belonging,”  encompassing the matters of language, discourse, culture; but, most notably, matter itself. Posthumanist thought has been influenced through Derrida’s writings on biology, founded through his conceptualization of trace [trace],  referring to that which formulates difference and its deferral of meaning [différance].  This postponement of action or event creates meaning and presence through absence, and is the opening in which binary oppositions can operate: those aforementioned concepts of life/death, extant/extinct, and nature/culture. Exploring the trace of bucardo and mammoth’s genomes poses to offer insights into what anabiosis ontologically and existentially is at present.

21 July 2019

Innovation and de-extinction

'Anticipating risks, governance needs, and public perceptions of de-extinction' by Rene X. Valdez, Jennifer Kuzma, Christopher L. Cummings and M. Nils Peterson in (2019) 6(2) Journal of Responsible Innovation 211-231 comments
Advances in biotechnology may allow for de-extinction. Potential impacts of de-extinct species remain uncertain; they may improve ecosystem function, or hinder conservation efforts and damage socio-ecological systems. To better anticipate de-extinction’s outcomes, ethical dilemmas, and governance needs, we surveyed experts from multiple disciplinary backgrounds. We applied a mixed-method approach to our analysis, integrating quantitative responses of perceived outcomes with qualitative responses, to clarify and provide context. Overall, respondents indicated de-extinction was more likely to induce hazards, not benefits. Reasons for this viewpoint included a ‘moral hazard’ argument, suggesting conservation policies could be undermined if society perceives that species need less protection because they can be revived later. Pessimistic views of de-extinction were linked to concerns about unclear development paths. Experts believed the public might be skeptical about de-extinction. Our results suggest future de-extinction efforts may benefit from collaborative efforts to clarify hazards and explore salient concerns among the engaged public.
The authors argue
Advances in biotechnology may allow for the de-extinction of species. De-extinction is the re-creation of extinct species using methods from synthetic biology, cloning, genetic engineering, reproduction technologies, and stem cell research. Numerous species are currently being considered as candidates for de-extinction, notably the passenger pigeon and woolly mammoth. De-extinction research on passenger pigeons includes genome sequencing (Hung et al. 2014), with plans to integrate DNA from preserved passenger pigeons into the genome of band-tailed pigeons (Novak 2013). Similarly, research on the woolly mammoth includes genome sequencing (Palkopoulou et al. 2015) with plans to gradually add mammoth genes into Asian elephant embryos, creating hybrids with progressively more mammoth traits (Devlin 2017). 
Arguments in-favor of de-extinction suggest that de-extinct species will improve ecosystem function, satisfy a moral obligation to revive extinct species, and re-invigorate efforts for conserve biodiversity. The ecological benefits of reintroducing de-extinct species may be the most significant potential outcome of de-extinction (Shapiro 2015; Iacona et al. 2017; McCauley et al. 2017). Potential ecological benefits of de-extinction are purportedly similar to restoring locally extirpated species (Jørgensen 2013; Seddon, Moehrenschlager, and Ewen 2014). For example, reintroduction of musk oxen, hares, and marmots to Pleistocene Park in Siberia altered plant distributions, facilitating grass- land restoration, and ultimately increasing biodiversity (Zimov 2005). Some researchers believe returning the woolly mammoth to the Siberian tundra might yield similar results (Shapiro 2015). As an act of restorative justice, reviving species driven to extinction by humans, such as the passenger pigeon, yields a moral good (Cohen 2014). This restorative act aligns with the goals of conservation biology, namely restoring ecological components and processes previously removed or damaged by human activities (Thorpe and Stanley 2011). Additionally, restoring animals like woolly mammoths may inspire great awe (Sherkow and Greely 2013) and lead to additional support for conservation. 
In contrast, arguments against de-extinction suggest that the process may be detrimental to conservation efforts and ecological systems, and rife with ethical dilemmas. Re-creation of extinct species may weaken conservation policies by providing a riskier alternative solution to preventing extinction (Pimm 2013). This moral hazard, or alternative solution, enables riskier behavior (Lin 2013), which is compounded by ecological change. Returning a re-created animal to its former ecosystem could be detrimental to the current, often different, ecosystem or to the de-extinct animal. For example, forests have been fragmented and degraded, and farms and urban systems have expanded in the historic passenger pigeon range (Greenberg 2014). If re-introduced, the bird may exhibit tendencies similar to invasive species (Sherkow and Greely 2013). Alternatively, a passenger pigeon may be unable to adapt to contemporary ecosystems. Would the creators of a de-extinct animal then be obligated to care for the de-extinct population in perpetuity? 
Ethical questions such as these extend beyond those considered during wildlife re-introductions (McCoy and Berry 2008) and include ownership responsibilities for de-extinct animals (Carlin, Wurman, and Zakim 2013). In most contexts, wildlife are considered common property until captured in some way (Blumm and Ritchie 2005), but de-extinction challenges these norms. Products of de-extinction may be eligible for patents based on their novelty or the technical processes used to create them (Carlin, Wurman, and Zakim 2013; Swedlow 2015). The potential commercial value could be derived from exclusive rights to exhibit, or by creating pet markets. Institutions that exhibit animals such as zoos typically require permitting under the Convention on International Trade in Endangered Species of Wild Fauna and Flora, and, in the United States, most zoos are regulated by the Animal Welfare Act (Grech 2004). There is considerable uncertainty regarding whether de-extinct animals should be considered endangered, native, exotic, or native and whether they would receive the corresponding protection or management (Camacho 2015; Okuno 2017). Further, attempts to reconstitute genomes and create hybrids, may be viewed as hubristic or similar to playing god (Sandler 2014). Playing god connotes individuals transgressing fixed limits on human behavior often linked to creation, and the pejorative label has been levied at biotechnology since its inception (Dabrock 2009). Although humans have a cultural duty to maximize positive impacts and minimize negative impacts on the world, accusations of playing god may have moral weight when they refer to technologies used to alter the biology of living organisms with unacceptable or unpredictable consequences or violate duties towards moral agents (Dabrock 2009). Animal rights and welfare concerns further complicate de-extinction. Animals such as the woolly mammoth are presumably social animals (Shapiro 2015), and rearing them in isolation may be cruel. 
Other potential de-extinction efforts (e.g. gastric-breeding frog or the Xerces butterfly) may require fewer physical accommodations (Seddon, Moehrenschlager, and Ewen 2014), but would still require navigating issues of public support and outdated biotechnology policies (Kuzma and Tanji 2010; Kuzma 2016). In the United States, federal regulation of biotechnology has not adapted to advancing biotechnological methods and novel products; for example, a de-extinct animal may be regulated following protocol originally intended for animal drugs (FDA 2009). Guiding principles have been suggested for selecting de-extinction candidates, by considering efficiency and feasibility (IUCN SSC 2016) and incorporating the 2013 IUCN Guidelines for Reintroduction and Other Conservation Translocations (Seddon, Moehrenschlager, and Ewen 2014). While these guidelines address many of the ecological risks involved in wildlife reintroduction efforts, such as ecological and socioeconomic impacts, disease risk, and feasibility, they assume opposition based on ethical principles will not matter, and that conservation policy will not inhibit de-extinction efforts. Further, these guidelines do not fully address issues associated with unique biotechnologies, higher uncertainty related to environmental risks, and more conflict between stakeholder groups compared to decision-making groups in traditional wildlife reintroduction efforts. 
A more systematic assessment of de-extinction seems necessary to anticipate risk and improve governance. In situations of high complexity and uncertainty, like de-extinction, it is especially important to anticipate risks so that appropriate governance systems are in place before technological deployment (Karinen and Guston 2009). Anticipatory governance suggests building capacities in foresight, engagement, and integration between experts (natural scientists, social scientists, and humanities scholars) and organizations (government agencies, technology developers, publics) may lead to better decisions and increased public good (Barben et al. 2007). In the absence of data on risks and benefits, expert elicitation provides a method for engaging the mental models of experts (Morgan, Henrion, and Small 1990) in order to begin the process of identifying potential risks and responding to them upstream in innovation and governance systems (Stilgoe, Owen, and Macnaghten 2013; Barben et al. 2007). 
As a first step in anticipatory governance, this paper presents the first analysis of the potential environmental impacts of de-extinction, ethical dilemmas, and governance needs by eliciting experts’ opinions from multiple disciplines. We surveyed experts in the natural sciences, social sciences, and the humanities, who have been involved in technologies and policies associated with genetic engineering and synthetic biology. Experts on biotechnology issues are well suited to assess potential de-extinction impacts, dilemmas, and governance needs because of their experiences with biotechnology development and governance. The science of biotechnology continues to develop, but at least in the United States, biotechnology policy has not explicitly addressed new genetic engineering technologies like gene editing, gene drives, or de-extinction (Kuzma 2016). International frameworks may cover genetically engineered animals, such as the Convention on Biological Diversity and the Cartagena Protocol on Biosafety, but these have not been ratified by all nations with active de-extinction research programs (Vàzquez-Salat et al. 2012; Kuzma 2016). Public opposition to genetically engineered foods is highly political, varies internationally, and is potentially becoming more controversial over time (Frewer et al. 2013). Controversies also brew within the biotechnology field as some products and companies fail to live up to their own hype (Borup et al. 2006). Biotechnology experts working within these contexts have unique experiences and can provide valuable assessments for the nascent field of de-extinction. To better anticipate the environmental impacts, ethical dilemmas, and governance needs for de-extinction, we applied a mixed-method approach to analyze quantitative responses regarding perceived risks and benefits with qualitative responses used to clarify and provide context. We compare participants’ perceptions of potential risks and benefits, highlight salient environmental and societal concerns, identify research and risk assessment needs for managing potential risks, and provide recommendations for de-extinction governance. This is the first study to our knowledge formally eliciting expert opinions about the governance of de-extinction. By conducting this study before viable, self-reproducing de-extinct species are developed, we hope to provide guidance to innovation and governance, promote environmental stewardship, and minimize unintended consequences.

19 April 2019

De-extinction

'Anticipating risks, governance needs, and public perceptions of de-extinction' by Rene X. Valdez, Jennifer Kuzma, Christopher L. Cummings and M. Nils Peterson in (2019) Journal of Responsible Innovation comments
 Advances in biotechnology may allow for de-extinction. Potential impacts of de-extinct species remain uncertain; they may improve ecosystem function, or hinder conservation efforts and damage socio-ecological systems. To better anticipate de-extinction’s outcomes, ethical dilemmas, and governance needs, we surveyed experts from multiple disciplinary backgrounds. We applied a mixed-method approach to our analysis, integrating quantitative responses of perceived outcomes with qualitative responses, to clarify and provide context. Overall, respondents indicated deextinction was more likely to induce hazards, not benefits. Reasons for this viewpoint included a ‘moral hazard’ argument, suggesting conservation policies could be undermined if society perceives that species need less protection because they can be revived later. Pessimistic views of de-extinction were linked to concerns about unclear development paths. Experts believed the public might be skeptical about de-extinction. Our results suggest future de-extinction efforts may benefit from collaborative efforts to clarify hazards and explore salient concerns among the engaged public.
The authors argue 
Advances in biotechnology may allow for the de-extinction of species. De-extinction is the re-creation of extinct species using methods from synthetic biology, cloning, genetic engineering, reproduction technologies, and stem cell research. Numerous species are currently being considered as candidates for de-extinction, notably the passenger pigeon and woolly mammoth. De-extinction research on passenger pigeons includes genome sequencing (Hung et al. 2014), with plans to integrate DNA from preserved passenger pigeons into the genome of band-tailed pigeons (Novak 2013). Similarly, research on the woolly mammoth includes genome sequencing (Palkopoulou et al. 2015) with plans to gradually add mammoth genes into Asian elephant embryos, creating hybrids with progressively more mammoth traits (Devlin 2017). 
Arguments in-favor of de-extinction suggest that de-extinct species will improve ecosystem function, satisfy a moral obligation to revive extinct species, and re-invigorate efforts for conserve biodiversity. The ecological benefits of reintroducing de-extinct species may be the most significant potential outcome of de-extinction (Shapiro 2015; Iacona et al. 2017; McCauley et al. 2017). Potential ecological benefits of de-extinction are purportedly similar to restoring locally extirpated species (Jørgensen 2013; Seddon, Moehrenschlager, and Ewen 2014). For example, reintroduction of musk oxen, hares, and marmots to Pleistocene Park in Siberia altered plant distributions, facilitating grassland restoration, and ultimately increasing biodiversity (Zimov 2005). Some researchers believe returning the woolly mammoth to the Siberian tundra might yield similar results (Shapiro 2015). As an act of restorative justice, reviving species driven to extinction by humans, such as the passenger pigeon, yields a moral good (Cohen 2014). This restorative act aligns with the goals of conservation biology, namely restoring ecological components and processes previously removed or damaged by human activities (Thorpe and Stanley 2011). Additionally, restoring animals like woolly mammoths may inspire great awe (Sherkow and Greely 2013) and lead to additional support for conservation. In contrast, arguments against de-extinction suggest that the process may be detrimental to conservation efforts and ecological systems, and rife with ethical dilemmas. Re-creation of extinct species may weaken conservation policies by providing a riskier alternative solution to preventing extinction (Pimm 2013). This moral hazard, or alternative solution, enables riskier behavior (Lin 2013), which is compounded by ecological change. Returning a re-created animal to its former ecosystem could be detrimental to the current, often different, ecosystem or to the de-extinct animal. For example, forests have been fragmented and degraded, and farms and urban systems have expanded in the historic passenger pigeon range (Greenberg 2014). If re-introduced, the bird may exhibit tendencies similar to invasive species (Sherkow and Greely 2013). Alternatively, a passenger pigeon may be unable to adapt to contemporary ecosystems. Would the creators of a de-extinct animal then be obligated to care for the de-extinct population in perpetuity? 
Ethical questions such as these extend beyond those considered during wildlife reintroductions (McCoy and Berry 2008) and include ownership responsibilities for deextinct animals (Carlin, Wurman, and Zakim 2013). In most contexts, wildlife are considered common property until captured in some way (Blumm and Ritchie 2005), but de-extinction challenges these norms. Products of de-extinction may be eligible for patents based on their novelty or the technical processes used to create them (Carlin, Wurman, and Zakim 2013; Swedlow 2015). The potential commercial value could be derived from exclusive rights to exhibit, or by creating pet markets. Institutions that exhibit animals such as zoos typically require permitting under the Convention on International Trade in Endangered Species of Wild Fauna and Flora, and, in the United States, most zoos are regulated by the Animal Welfare Act (Grech 2004). There is considerable uncertainty regarding whether de-extinct animals should be considered endangered, native, exotic, or native and whether they would receive the corresponding protection or management (Camacho 2015; Okuno 2017). Further, attempts to reconstitute genomes and create hybrids, may be viewed as hubristic or similar to playing god (Sandler 2014). Playing god connotes individuals transgressing fixed limits on human behavior often linked to creation, and the pejorative label has been levied at biotechnology since its inception (Dabrock 2009). Although humans have a cultural duty to maximize positive impacts and minimize negative impacts on the world, accusations of playing god may have moral weight when they refer to technologies used to alter the biology of living organisms with unacceptable or unpredictable consequences or violate duties towards moral agents (Dabrock 2009). Animal rights and welfare concerns further complicate de-extinction. Animals such as the woolly mammoth are presumably social animals (Shapiro 2015), and rearing them in isolation may be cruel. 
Other potential de-extinction efforts (e.g. gastric-breeding frog or the Xerces butterfly) may require fewer physical accommodations (Seddon, Moehrenschlager, and Ewen 2014), but would still require navigating issues of public support and outdated biotechnology policies (Kuzma and Tanji 2010; Kuzma 2016). In the United States, federal regulation of biotechnology has not adapted to advancing biotechnological methods and novel products; for example, a de-extinct animal may be regulated following protocol originally intended for animal drugs (FDA 2009). Guiding principles have been suggested for selecting deextinction candidates, by considering efficiency and feasibility (IUCN SSC 2016) and incorporating the 2013 IUCN Guidelines for Reintroduction and Other Conservation Translocations (Seddon, Moehrenschlager, and Ewen 2014). While these guidelines address many of the ecological risks involved in wildlife reintroduction efforts, such as ecological and socioeconomic impacts, disease risk, and feasibility, they assume opposition based on ethical principles will not matter, and that conservation policy will not inhibit deextinction efforts. Further, these guidelines do not fully address issues associated with unique biotechnologies, higher uncertainty related to environmental risks, and more conflict between stakeholder groups compared to decision-making groups in traditional wildlife reintroduction efforts. 
A more systematic assessment of de-extinction seems necessary to anticipate risk and improve governance. In situations of high complexity and uncertainty, like de-extinction, it is especially important to anticipate risks so that appropriate governance systems are in place before technological deployment (Karinen and Guston 2009). Anticipatory governance suggests building capacities in foresight, engagement, and integration between experts (natural scientists, social scientists, and humanities scholars) and organizations (government agencies, technology developers, publics) may lead to better decisions and increased public good (Barben et al. 2007). In the absence of data on risks and benefits, expert elicitation provides a method for engaging the mental models of experts (Morgan, Henrion, and Small 1990) in order to begin the process of identifying potential risks and responding to them upstream in innovation and governance systems (Stilgoe, Owen, and Macnaghten 2013; Barben et al. 2007). 
As a first step in anticipatory governance, this paper presents the first analysis of the potential environmental impacts of de-extinction, ethical dilemmas, and governance needs by eliciting experts’ opinions from multiple disciplines. We surveyed experts in the natural sciences, social sciences, and the humanities, who have been involved in technologies and policies associated with genetic engineering and synthetic biology. Experts on biotechnology issues are well suited to assess potential de-extinction impacts, dilemmas, and governance needs because of their experiences with biotechnology development and governance. The science of biotechnology continues to develop, but at least in the United States, biotechnology policy has not explicitly addressed new genetic engineering technologies like gene editing, gene drives, or de-extinction (Kuzma 2016). International frameworks may cover genetically engineered animals, such as the Convention on Biological Diversity and the Cartagena Protocol on Biosafety, but these have not been ratified by all nations with active de-extinction research programs (Vàzquez-Salat et al. 2012; Kuzma 2016). Public opposition to genetically engineered foods is highly political, varies internationally, and is potentially becoming more controversial over time (Frewer et al. 2013). Controversies also brew within the biotechnology field as some products and companies fail to live up to their own hype (Borup et al. 2006). Biotechnology experts working within these contexts have unique experiences and can provide valuable assessments for the nascent field of de-extinction. To better anticipate the environmental impacts, ethical dilemmas, and governance needs for de-extinction, we applied a mixedmethod approach to analyze quantitative responses regarding perceived risks and benefits with qualitative responses used to clarify and provide context. We compare participants’ perceptions of potential risks and benefits, highlight salient environmental and societal concerns, identify research and risk assessment needs for managing potential risks, and provide recommendations for de-extinction governance. This is the first study to our knowledge formally eliciting expert opinions about the governance of de-extinction. By conducting this study before viable, self-reproducing de-extinct species are developed, we hope to provide guidance to innovation and governance, promote environmental stewardship, and minimize unintended consequences

24 February 2019

De-extinction

'A Criminology of Extinction: Biodiversity, extreme consumption and the vanity of species resurrection' by Avi Brisman and Nigel South in European Journal of Criminology (forthcoming) comments
This article explores an issue pertaining to the commodification of nature and related market processes—reviving extinct species. It begins by offering an overview of the aesthetic, economic, scientific and ethical reasons to preserve biological diversity. The article then considers how and why biological diversity is actually being reduced at an unprecedented rate—the ways in which, and the explanations for why, human acts and omissions are directly and indirectly, separately and synergistically, causing extinctions— quite possibly of species that we do not even know exist. From here, the article draws on the growing body of research on resurrecting species — a process known as de-extinction — to contemplate the questions raised about the permanency of extinction, as well as whether we should revive extinct species and the meaning and criminological implications of doing so. 
The authors comment
Significant international work in recent years has drawn attention to “animal abuse,” “wildlife crime” and, more broadly, harms and crimes affecting non-human species (Bayrachnaya et al., 2018; Beirne, 1995, 1997, 1999, 2009, 2014; Gibbs et al., 2010; Maher and Sollund, 2016; Maher et al., 2016; Moreto, 2018; Nurse, 2013, 2015; Pires and Clarke, 2011; Sollund 2011, 2013a, 2013b, 2015; Wyatt, 2013). In some respects, this work has been pioneering. In other ways, it builds on the past work of others and serves as a reminder of the historical complexity of human-non-human relations. Bryant (1979:412) made an early call for the study of “zoological crime”—a term coined to refer to the violation of “animal related social norms . . . [that] may well be among the most ubiquitous of any social deviancy.” Beirne’s (1995) essay, some sixteen years later, was, in part, a frustrated reaction to the failure to respond to Bryant’s proposal. Although Beirne (1995:5) acknowledged that “the field of crimes against animals does not yet constitute a recognized, let alone a coherent, object of study,” he maintained that it would be inaccurate to state that “animals are never present in criminological discourse,” and he noted the wide range of materials involving animals as central figures in relation to “inter alia, the configuration of rural class relations in 18th-century England, the alleged links between crime and human nature, and the behavioral manifestations of children who are likely to be violent as adults.” For example, the American scholar and linguist E.P. Evans (1906/1987) had documented the role nonhuman animals play in human society in The Criminal Prosecution and Capital Punishment of Animals, while historians such as E.P. Thompson, Linebaugh and others outlined the importance of wildlife in terms of property law, moral economies, class oppression, and social and environmental transformation (Hay, 1975; Linebaugh, 1976; Thompson, 1975). Game laws and poaching/anti-poaching activities and initiatives reflect centuries of human relationships with nature, as have measures aimed at balancing conservation, culling, hunting for sport, and killing for food. Many sociological studies of deviance and leisure have produced descriptive accounts of the recreational pursuit of wildlife, abuse of animals, and breaking of wildlife protection laws (Eliason, 2003; Nurse, 2013).
Hence, although Moreto and colleagues (2015:360) may in general be correct that law enforcement and criminal justice systems have accorded wildlife offences a “low priority when compared to other crimes (Cook et al. 2002),” this is not to suggest they have been ignored completely or have not been regarded as important.
Criminological attention to poaching, trafficking and related animal abuse is now substantial, and encompasses contributions aimed at market reduction and enhancing conservation efforts (e.g., Lee et al., 2014; Schneider, 2008; Shepherd, 2017). While all of this represents a welcome shift, attention to the dynamics of the illegal market for a particular species or the investigation of the scope, extent, and geographical range of the international trade in specific wildlife as live bodies or as harvested “parts and products” has overshadowed—and has perhaps come at the expense of—broader criminological considerations of “biological diversity” (or “biodiversity”) loss, decline and extinction, of which wildlife crime is but one cause (see, e.g., http://www.cnn.com/interactive/2016/12/specials/vanishing/).
In 2016, the World Wildlife Fund for Nature’s Living Planet Report (WWF, 2016: 4) noted that for some decades, “scientists have been warning that human actions are pushing life toward a sixth mass extinction” (see also Kolbert, 2014; Mirzoeff, 2014:227 (citing Novoacek 2007)). The data from the Living Planet Index—which offers an indication of the state of global biological diversity, based on trends in the populations of vertebrate species from around the world—show that between 1970 and 2012, the planet experienced a “58 per cent overall decline in vertebrate population abundance” with populations of vertebrate species falling, on average, “by more than half in little more than 40 years … an average annual decline of 2 per cent,” with “no sign yet that this rate will decrease.” This decline of other species is one measure of the magnitude of human impact on the planet stemming from the expansion and acceleration of human activity designed to meet the demands of human survival as a growing global population needs more food, requiring more human engineered change to natural habitats (e.g., deforestation) and contributing to more over-fishing and over-hunting (EEA, 2015).
Along with pollution and global warming, these anthropogenically-induced pressures on the planetary ecosystem are now sending warning signals (Brannen, 2017). Some believe that by responding to these signals now, policy changes and technological developments can help provide remedies; others caution that some change is already irreversible and only drastic reorganization of global economic and consumption systems can slow down species decline and extinctions (for a discussion, see, e.g., Ripple et al., 2017).
This article considers human contributions to the rate of loss of biological diversity, beliefs that science and regulation can control the extent and nature of any consequences (Fukuyama, 2002; Wilson, 1998, 2004), and related efforts to explore the plausibility, viability and implications of reviving extinct species (Wray, 2017). It first provides an overview of the reasons for preserving biological diversity, before turning to an outline of the causes of recent (unprecedented) extinctions. The implications of extinction trends have been explored thoroughly within relevant natural sciences and some areas of the social sciences, but not so far within criminology. This article explores the prospects of species extinction in terms of the merger of conservation and consumerism (e.g., “conservation tourism” (AWF, n.d.; Buckley, 2010)), as well as the bases for denial and deferral of action furnished by faith in the new science of “de-extinction.” It concludes by arguing the case for considering “extinction” as a matter of criminological concern, and for why this is not only justifiable but necessary.
'Ancient Genetics to Ancient Genomics: Celebrity and Credibility in Data-Driven Practice' by Elizabeth D. Jones  (2019) comments 
 The search for DNA from ancient and extinct organisms – a practice now known worldwide as “Ancient DNA Research” – surfaced from the interface of paleontology, archeology, and molecular biology in the 1980s, then evolved from an emergent into a more established scientific and technological practice today. Throughout the decades, this novel approach to the study of fossils has grown under intense press and public interest, particularly as it coincided with and was catalyzed into the media spotlight by the book and movie Jurassic Park in the 1990s. Ancient DNA continues to capture professional and popular attention as researchers have recovered genetic material from extinct mammoths to early humans and Neanderthals in an attempt to refine or even rewrite our understanding of evolutionary history. This practice also captures public curiosity because of speculation – inspired by media reports as well as scientific research – that DNA may one day be used to bring extinct species back to life. Broadly, ancient DNA research is the practice of extracting, sequencing, and analyzing degraded or damaged DNA from dead organisms that are hundreds to thousands of years old. Ancient DNA has been recovered from organisms such as plants, animals, humans, and bacteria, and can be preserved in skins, tissues, and even bone if the bone is not a fully mineralized fossil.  However, it is important to note that the term “ancient” does not necessarily relate to the age of the DNA but to the characteristic damage patterns that occur as DNA breaks down after an organism has died. Given the degraded nature of this genetic material, research into DNA from ancient and extinct species requires specialist skills and technologies. Many researchers are interested in adapting state-of-the-art molecular biological techniques and high-throughput sequencing technologies in order to optimize the recovery of ancient DNA. They are also interested in using this DNA for the primary purpose of studying the evolutionary history of extinct and extant organisms as well as testing hypotheses about evolution, such as the drivers of patterns of genetic variation, regions of the genome under selection, and the migrations of past populations. At the same time, however, the ability to recover DNA from fossils has been closely connected to the idea of using DNA to resurrect extinct species. Since the 1980s, speculation about resurrection has followed the field closely, influencing the development of this practice over a prolonged period of time. 
Drawing on historical and archival material, interviews with scientists, and philosophical literature, this paper presents the search for DNA from fossils, throughout its disciplinary development from the 1980s to today, as a data-driven and celebrity-driven practice. This paper proceeds in three parts. First, I deliver a condensed history of ancient DNA research from the 1980s to today with attention to the role that technology as well as consistent press and public interest played in its growth from a curious idea into a credible practice within evolutionary biology. Second, I introduce interviewees’ memories of their history and analyze their perspectives on the historical and philosophical development of ancient DNA activity as an extended episode of boundary-work. In attempts to make sense of their history as a science in the spotlight, interviewees try to draw a line between their past and present in order to portray the practice as a more question-driven, and therefore more mature, area of research today. Finally, I discuss the role of celebrity and credibility in the data-driven practice of ancient DNA research.

24 January 2019

Mammoths Again

'Won’t Somebody Please Think of the Mammoths? De-extinction and Animal Welfare' by Heather Browning in (2019) Journal of Agricultural and Environmental Ethics 1-19 comments
 De-extinction is the process through which extinct species can be brought back into existence. Although these projects have the potential to cause great harm to animal welfare, discussion on issues surrounding de-extinction have focussed primarily on other issues. In this paper, I examine the potential types of welfare harm that can arise through de-extinction programs, including problems with cloning, captive rearing and re-introduction. I argue that welfare harm should be an important consideration when making decisions on de-extinction projects. Though most of the proposed benefits of these projects are insufficient to outweigh the current potential welfare harm, these problems may be overcome with further development of the technology and careful selection of appropriate species as de-extinction candidates.
Browing argues
 There are three methods through which de-extinction can be achieved: selective breeding, cloning and genetic engineering (Cohen 2014; Shapiro 2015). Each of these has different benefits and drawbacks and is useful for different cases. The first of these methods is selective breeding, or back-breeding. In this process, current relatives are selectively bred for those characteristics that defined the extinct species. For example, in order to re-create mammoths, elephants could be successively bred for their larger and hairier variations, until something closely resembling a mammoth is created. There are currently a few programs using back-breeding to attempt to recreate extinct species—projects attempting to bring back the quagga are selectively breeding zebras (Cohen 2014), and to bring back Auroch through selective breeding of modern-day cattle (Shapiro 2017). The process is limited by the availability of sufficiently similar relatives that are still capable of expressing the desired traits. 
The second method is somatic cell nuclear transfer (SCNT), or cloning. This requires the nucleus of a cell taken from a recovered member of the species to be implanted into an egg cell of a related surrogate species. This creates a zygote genetically identical to the donor animal of the target extinct species. The zygote is then gestated and birthed by the surrogate animal. A famous example of the use of this process was in the creation of ‘Dolly’ the sheep. This has also been attempted for de-extinction purposes, in the cloning of the Pyrinean ibex, or Bucardo, where a clone was made of the last living individual; though this clone did not survive long after birth (Cohen 2014). There has reportedly been some success in using this technique for creating new embryos of the extinct gastric-brooding frog (Cohen 2014). This process is only possible where entire cells of the extinct species are available, which is only the case for very recent extinctions, and where appropriate surrogate species can be identified (Shapiro 2017). 
The third de-extinction method is genetic engineering. Here, DNA is recovered from preserved specimens of the extinct species. As it is almost never entirely intact, it is spliced with the DNA of a related species to create the closest possible genetic match to the original target. The spliced genetic material is then used to create a zygote to be gestated and birthed by an extant surrogate animal. Most current work on de-extincting mammoths is using this method, as the remaining mammoth DNA exists only in fragments. It is also the primary method in use for de-extinction of the passenger pigeon (Cohen 2014). This is what Shapiro (2017) considers the “most likely route to de-extinction” (2017, p. 4) as it only requires fragmentary DNA from the target species, which can then be expanded into a whole genome. It is limited primarily through availability of preserved DNA, which rules out long-extinct species, and like the cloning techniques, requires the use of closely related living species both for use of their DNA for gene editing, and as surrogate mothers (Shapiro 2017). 
All of these methods for de-extinction are being used in current projects on various species, and each presents potential animal welfare problems, which I will detail in the “Welfare Issues” section. This is not merely hypothetical—de-extinction projects are happening now, and the welfare concerns for the animals thus created should be the focus of attention when evaluating these projects. ... 
In the past few years, de-extinction has become the centre of increasing scientific and philosophical focus, with a number of books and papers published on the scientific feasibility of and ethical issues surrounding such projects. I will summarise these here, before moving on in the next section to examine the animal welfare concerns, which have not yet been given much attention in the literature. 
Firstly, there is the question of whether or not the animals created through these methods count as members of the original species. Although they will be genetically similar to the target species, they will still have some differences in genotype, phenotype and development, that may rule them out as part of the species (Shapiro 2017). It is thus uncertain whether the species can really be said to have been brought back from extinction, or whether we have simply created a new, similar species to fill the same role. This question, and its implications, will be discussed further in the “Weighing Up Potential Benefits” section. 
Another set of issues relate to scientific feasibility; whether the breeding and cloning methods can even work. Further, if animals are intended for reintroduction, this raises questions as to how we should select species such that they have the highest chance of success when reintroduced (Jones 2014). There are concerns as to whether the necessary environments for release still exist, and whether the animals can undergo the required behavioural training for release (Blockstein 2017). There are also legal issues, as to what the status of the de-extinct and re-introduced animals would be (e.g. native or introduced) and how this would affect conservation and protection legislation (Camacho 2015). 
A number of papers have also addressed the ethical concerns of de-extinction projects, across a range of issues. For example, whether this sort of targeted ‘precision’ conservation is in conflict with a more wholistic form of ecosystem conservation (Adams 2017). There are suggestions that resources spent on de-extinction programs could result in decreased support for conservation of extant species, through loss of actual or potential sources of funding (Bennett et al. 2017). Campagna et al. (2017) are concerned that the discussion of de-extinction could “give the impression that extinction is reversible” and will therefore “diminish the gravity of the human annihilation of species” (2017, p. 48). Davis and Moran (2016) express concern that release of de-extinct species carries the risks of “invasiveness, disease transmission, and unforeseen species interactions” (2016, p. 3) and call for field research using similar surrogate species in order to minimise these risks. Another criticism of the process is that it is ‘unnatural’—both in terms of the technologies that are used to recreate the species, and in terms of the nature of the species thus created (Mason 2017). All these questions have already been well-explored and will not be re-examined further here; instead I will now turn to the issues of animal welfare arising from de-extinction projects. 
Welfare Issues 
Until recently, what has been absent in discussions of de-extinction is an exploration of the issues relating to the welfare of the animals created through these projects. Although mentioned briefly in many of the papers discussing ethical issues, animal welfare concerns are typically given only a few lines. These usually indicate that these issues are important but should not be difficult to work out, as they are the same sorts of issues that show up in other projects involving scientific research and species reintroduction. For example, Cohen (2014) brings up harm to animals as a potential source of negative utility in considerations of de-extinction projects but concludes “there is no reason to think de-extinction will cause a large animal welfare problem” (2014, p. 175). Sandler (2014) considers animal welfare concerns as a potential ethical reason against de-extinction projects but concludes “compared with the number of animals already used in research … conservation cloning does not pose a special or very large animal welfare problem” (2014, p. 358). Although he acknowledges that research should take care to minimise suffering caused, he thinks “the animal welfare concerns it raises do not significantly differentiate it from many other research and conservation practices involving animals” (2014, p. 358). Rohwer and Marris (2018) point out that “creating a mammoth is morally permissible … provided that suffering is minimal” (2018, p. 2, italics in original), and go on to describe some of the concerns with cloning, surrogacy and rearing; though again, follow Sandler in dismissing these as not much different from those in other similar conservation practices. Greely (2017) describes the potential welfare problems associated with cloning technology but considers that “the risks of de-extinction are not substantively different from those associated with gene editing” (2017, p. 34). Friese and Marris (2014) briefly describe some of the welfare concerns in the creation and rearing of de-extinct animals, and argue that “questions regarding animal care need to be understood as a crucial part of de-extinction experimentation, rather than downstream concerns” (2014, p. 2), however they conclude that these issues can be addressed through “a social science approach based upon the current realities of cloning, genetic engineering, back breeding, and species preservation today” (2014, p. 3). 
Only Kasperbauer (2017) has really emphasised the importance of animal welfare considerations in making decisions about de-extinction programs, labelling it as “the most critical challenge for de-extinction” (2017, p. 1). He argues that “the current state of de-extinction technology provides good reasons to think the lives of de-extinct animals will indeed be full of suffering” (2017, p. 6) due to problems with cloning technology and reintroduction, and briefly outlines some of the ways in which these potential harms could come about. Here I will examine in detail exactly how and why these situations are likely to be harmful to animal welfare. 
Although it is true that many of the welfare issues are continuous with those affecting other areas of animal research and conservation, I argue that de-extinction creates special issues for animal welfare that need to be considered when evaluating such projects. Welfare issues can affect the de-extinct animals, other animals used in the process (e.g. surrogate mothers) and the wild animals that will be impacted through reintroduction (Cohen 2014). In particular, there are welfare issues surrounding the cloning procedures when these are used, and in the process of captive rearing and reintroduction, beyond those usually faced by zoos or conservation bodies doing this sort of work. This is in large part due to the lack of knowledge about these species and their requirements.

15 June 2018

FDA regulation and the CRISPR Zoo

‘A Menagerie of Moral Hazards: Regulating Genetically Modified Animals’ by Sarah Polcz and Anna C.F. Lewis in (2018) 40 The Journal of Law, Medicine and Ethics  180-184 comments
Dairy cattle naturally grow long and dangerous horns. So as a protective measure, farmers permanently remove calves’ small horns through a painful procedure. Recently, scientists have used modern genetic editing techniques to create dairy cattle that never develop horns, and so never need to be “dehorned.” The regulatory fate of these genetically dehorned cattle may be bound up with numerous more controversial cases from the same rapidly diversifying field: the genetic editing of animals. Or, at least so it could be under draft Food and Drug Administration (FDA) guidance which closed for public commentary in June 2017. The FDA’s challenge is to chart a flexible regulatory course. One which will support the potential of gene-editing technology, while staking out the boundaries of acceptable risks — i.e. the ethical boundaries — of the looming “CRISPR zoo.” Here we review the background to the draft guidance, as well as the scathing comments it received from disparate interest groups. The comments show that to foster public trust in how gene-editing technologies are used, it is imperative that the FDA re-engage with all stakeholders, including the public at large. 
In its draft guidance, the FDA proposed to regulate “intentionally altered genomic DNA” of animals as a drug being evaluated for use in animals. The original altered animal and all its progeny would be subject to the animal drug regulations. The FDA invited comments on these proposed amendments. As we discuss here, a mere handful of the 151 comments received were supportive,4 and most were extremely critical, including those from the National Association of State Departments of Agriculture (NASDA). We argue that the FDA’s proposals are unsatisfactory and should be withdrawn.
The authors conclude
 We agree that the product should be the subject of regulation, and not the process that created it. A focus on product would force the FDA to clarify its regulatory intent, increas- ing transparency not just for product developers, but also for the public. It would elevate the importance of understanding risk, a view that was shared by a broad cross section of commenters. By contrast, a focus on process bunches diverse applications under one umbrella, from curing inherited diseases to adding in genes from distant species, from food to de- extinction of animals. And it divides products that should be considered together. In contrast, the USDA excluded from its proposed regulations any genetically modified organ- ism that could have been produced using traditional breeding techniques because “[s]uch organisms are essentially identical, despite the method of creation.” 
Moreover, history has shown that biotech regulations focusing on process have a frustratingly short shelf life. Regulation introduced in 2009 focused on process, calling out recombinant DNA. Just a few years later, new technologies arrived that are not covered by that regulation. Updating guidance with updated technologies repeats the original error. Already technology is outpacing proposals: mice have had their epigenomes successfully edited, and as these terms are currently understood they would not qualify as having “intentionally altered genomic DNA”. 
A focus on process has allowed the FDA to avoid answering tough product questions. This needs to change. The approach proposed by the NAS in its report concerning the future products of biotechnology, in our opinion represents a sound core for a revised approach: a single cross-agency entry point for the risk based appraisal of new products. In the context of technology designed to affect animals, an additional concern should be for animal welfare. Technology such as gene editing has huge potential to not only improve animal welfare, but also to decrease it. 
The lack of consistency across different agencies concerning geneti- cally altered organisms is not only confusing within the U.S., it makes it almost impossible for other coun- tries to follow the U.S.’s lead. The aim should be internal consistency within the U.S. as part of a cohesive international approach for these international issues: protection from large-scale risk while helping provide for the food security and better health of humanity. 
Finally, the FDA received a similar number and spread of comments as the USDA received in reaction to its proposals. The same arguments cited by the USDA in withdrawing its own proposals apply equally to the FDA. In both cases, the propos- als clearly fail to attract even minimal support from a broad range of commenters. Moreover, as the USDA noted, the publication of the proposed rules constrained its ability to explore alternatives with stakeholders. The withdrawal opened up the opportunity for “a more open and robust policy dialogue.” Given the opposition to the proposals, it would be consistent for the FDA to likewise withdraw them as a first step towards a cohesive framework. Then we can start the much needed dialog to build a risk-based approach, both for gene-editing and for the biotechnologies to come.

05 May 2017

Mammoth Fever

'Frankenstein's Mammoth: Anticipating the Global Legal Framework for De-Extinction' by Erin Okuno in (2016) 43(3) Ecology Law Quarterly comments
Scientists around the world are actively working toward de-extinction, the concept of bringing extinct species back to life. Before herds of woolly mammoths roam and flocks of passenger pigeons soar once again, the international community needs to consider what should be done about de-extinct species from a legal and policy perspective. In the context of international environmental law, the precautionary principle counsels that the absence of scientific certainty should not be used as an excuse for failing to prevent environmental harm. No global legal framework exists to protect and regulate de-extinct species, and this Article seeks to fill that gap by anticipating how the global legal framework for de-extinction could be structured. 
The Article recommends that the notions underlying the precautionary principle should be applied to de-extinction and that the role of international treaties and other international agreements should be considered to determine how they will or should apply to de-extinct species. The Article explains the concepts of extinction and de-extinction, reviews relevant international treaties and agreements, and analyzes how those treaties and agreements might affect de-extinct species as objects of trade, as migratory species, as biodiversity, as genetically modified organisms, and as intellectual property. 
The Article provides suggestions about how the treaties and the international legal framework could be modified to address de-extinct species more directly. Regardless of ongoing moral and ethical debates about de-extinction, the Article concludes that the international community must begin to contemplate how de-extinct species will be regulated and protected under existing and prospective international laws and policies.

23 March 2017

De-extinction

'Spending limited resources on de-extinction could lead to net biodiversity loss' by Joseph R. Bennett, Richard F. Maloney, Tammy E. Steeves, James Brazill-Boast, Hugh P. Possingham and Philip J. Seddon in (2017) 1 Nature Ecology & Evolution 0053 comments
There is contentious debate surrounding the merits of de-extinction as a biodiversity conservation tool. Here, we use extant analogues to predict conservation actions for potential de-extinction candidate species from New Zealand and the Australian state of New South Wales, and use a prioritization protocol to predict the impacts of reintroducing and maintaining populations of these species on conservation of extant threatened species. Even using the optimistic assumptions that resurrection of species is externally sponsored, and that actions for resurrected species can share costs with extant analogue species, public funding for conservation of resurrected species would lead to fewer extant species that could be conserved, suggesting net biodiversity loss. If full costs of establishment and maintenance for resurrected species populations were publicly funded, there could be substantial sacrifices in extant species conservation. If conservation of resurrected species populations could be fully externally sponsored, there could be benefits to extant threatened species. However, such benefits would be outweighed by opportunity costs, assuming such discretionary money could directly fund conservation of extant species. Potential sacrifices in conservation of extant species should be a crucial consideration in deciding whether to invest in de-extinction or focus our efforts on extant species.
Technological advances are reducing the barriers to resurrecting extinct species or their close genetic proxies, allowing de-extinction to be considered as a biodiversity conservation tool. Arguments in favour of de-extinction include necessity, driven by the rapid rate of species and habitat loss, an ethical duty to redress past mistakes, as well as potential technological and ecological knowledge that could stem from de-extinction programmes. Counter-arguments include high risk of failure due to difficulties of cloning for some species, technical risks inherent in re-introductions , loss of culture in resurrected animal species, and lack of remaining habitat for some species, as well as negative consequences for extant species, including reduced incentive for traditional conservation, and ecological impacts of introducing long-absent or genetically modified species.
The relative cost versus benefit for biodiversity is fundamental to the debate surrounding de-extinction. Assuming species are resurrected to be released into former habitats, the cost of de-extinction includes the process of producing initial founder populations, translocating individuals, then monitoring and managing new wild populations. If conservation funds are re-directed from extant to resurrected species, there is risk of perverse outcomes whereby net biodiversity might decrease as a result of de-extinction. Although private agencies might fund the resurrection of extinct species out of technical or philanthropic interest, the subsequent ongoing management of such species (many of which would face the same threats that made them extinct) would fall on government agencies, as commonly occurs with extant threatened species. Alternatively, if private agencies are willing to provide new funding for post de-extinction management, there could be additional benefits to species sharing habitats or threats.
Here, we test the potential impact of establishing and sustaining wild populations of resurrected extinct species (or proxies of such species) on the conservation of extant species. Specifically, we use long-term conservation programmes for extant analogue species in New Zealand (NZ) and the Australian state of New South Wales (NSW), to infer potential conservation actions for resurrected species, and predict the impact of resurrected species programmes on conservation of extant species. We use these datasets because they contain detailed prescriptions and costs of actions designed to achieve population recovery for most of the extant threatened species requiring specific management actions in either jurisdiction. We estimate the net number of extant species that can be conserved, using the following scenarios:
(1) establishment and maintenance of resurrected species become the burden of government conservation programmes, and
(2) establishment and maintenance of resurrected species populations are funded externally using non-public resources.
In Scenario 1, the use of government resources on resurrected species results in less funding for extant species programmes, but provides potential benefits for species that share actions with resurrected species. In Scenario 2, there are also potential benefits to extant species conservation programmes through shared conservation actions. However, there are potential opportunity costs, if private agencies use resources they could otherwise have used on conservation of extant species. Our analysis assumes that species would be resurrected to be re-introduced into their former habitats, rather than for other potential reasons, such as research or public display.

14 June 2016

De-extinction

'Making De-Extinction Mundane?' by Friese and Marris in (2014) 12(3) PLoS Biology e1001825 argues
 The use of new technologies to bring back extinct species has recently become a topic widely discussed in the media, partly as the result of a TEDx programme on de-extinction at the National Geographic Headquarters, timed to coincide with a National Geographic cover story in April 2013. Two weeks earlier, Stuart Brand, a key proponent of de-extinction, gave his own TED talk. These public events were followed by high-profile conferences at Cambridge (UK) and Stanford Universities. These events have begun to shape the contours of ‘de-extinction,’ by defining the relevant techniques (cloning, genome editing, back breeding, stem cell manipulation) and also the actors that can legitimately participate. Thus, de-extinction is currently crystalizing into a field that includes not only bioscientists but also, to varying degrees, the popular press, bioethicists, conservationists, and scientists from other fields (for example, synthetic biologists). 
De-extinction has raised a number of ethical and political questions: Will it divert resources from other tried-and-tested measures for conservation? Will the resurrected animals be classified as members of the extinct species? Are conservationists too pessimistic and sceptical about cutting-edge science to embrace its potential? How will we ethically care for the animals used in and produced by these techniques? Are there hidden commercial interests at stake? What is striking, from our perspective, is that many of these debates have been held before: the tropes regarding de-extinction are remarkably similar to those used in debates regarding cloning endangered animals. 
In this paper, we explore the relevance of previous debates and argue that important insights can be gleaned from them as de-extinction moves forward, and that there is another set of questions that has not yet been adequately addressed. In line with the arguments of Marris and Rose in the opening editorial for this series “Opening Engagement: Exploring Public Participation in the Biosciences,” we examine how, in the field of cloning endangered animals, the concerns of conservationists have in some cases been the basis for reformulating scientific practices in a way that can be interpreted as a form of ‘upstream’ public engagement. We argue that de-extinction could learn valuable lessons from these earlier projects regarding how to incorporate contributions from various publics; and demonstrate what a sociological approach can add to the exploration of these questions, in ways that traditional bioethics and ELSI (Ethical, Legal and Social Implications) approaches cannot.
'From dinosaurs to dodos: who could and should we de-extinct?' by Kate Elizabeth Jones in (2014)  6(1) Frontiers of Biogeography comments
 Reviving extinct species with new synthetic biology tools is as exciting an idea as it is controversial. Genomic manipulation of extinct species’ close relatives and/or cloning suitably preserved cells are the two main ways synthetic biology could be used to revive species. Discussions of where to target initial revival efforts have focused on species’ charisma (e.g. Woolly mammoth, Passenger pigeon) with less emphasis on feasibility or the ecological, ethical and legal considerations. Here I discuss who we could and should de-extinct, focussing on these latter criteria. Given the current devastating anthropogenic pressures on biodiversity, I suggest that a better use of de-extinction technologies would be to focus them on preventing species extinctions by restoring populations of critically endangered species. For example, this could be through increasing population numbers through cloning or genomic manipulation to better enable susceptible species to adapt to global change or by restoring genetic diversity by reviving extinct sub-species (e.g. Quagga, Barbary lion). This idea circumvents many of the criticisms of de-extinction from conservationists, whilst retaining public interest in de-extinction.
'CRISPR Critters and CRISPR Cracks' by R. Alta Charo and Henry T. Greely in (2015) 15(12) The American Journal of Bioethics 11-17 comments on
possible nonhuman applications of CRISPR/Cas9 that are likely to be widely overlooked because they are unexpected and, in some cases, perhaps even “frivolous.” We look at five uses for “CRISPR Critters”: wild de-extinction, domestic de-extinction, personal whim, art, and novel forms of disease prevention. We then discuss the current regulatory framework and its possible limitations in those contexts. We end with questions about some deeper issues raised by the increased human control over life on earth offered by genome editing.
'The Woolly-Mammoth in the Room: The Patentability of Animals Brought Back From Extinction Through Cloning and Genetic Engineering' by Miriam R. Swedlow in (2015) 11(3) Washington Journal of Law, Technology and Arts 185 comments
Advances and success in cloning and genetic engineering may mean passenger pigeons, dodos, gastric- brooding frogs, thylacines, woolly mammoths, and other extinct species will once again grace this planet. As de-extinction becomes a reality, it is uncertain whether these animals are patent eligible. Diamond v. Chakrabarty opened the door to cloning multicellular organisms. Since then, the U.S. Patent Office’s Board of Patent Appeals and Interferences has found “non-naturally occurring, man- made organisms including animals” to be patentable subject matter under 35 U.S.C. § 101. Because the initial case challenging this decision failed on procedural grounds, the underlying legal issue has not been addressed in a federal court. Congress forbids patents directed at, or encompassing, human organisms, but has been silent with respect to animals. The Supreme Court holds that sections of naturally occurring DNA are not patent eligible, while non-naturally occurring synthetic strands are. But the Court has not considered organisms created from both naturally occurring and synthetic DNA, as would be the case in de-extinction. The Federal Circuit upheld a decision denying a patent for Dolly the cloned sheep, yet left room for successful patents of other cloned animals. The Federal Circuit’s distinction may lie between patenting the clone of an animal that already exists and patenting an animal that does not or no longer exists. In light of ever- changing science and technology, there are few clear boundaries of what organisms can or cannot be patented. Practitioners need to be aware of the boundaries and the gray areas in the existing law to navigate a path towards patentability of de-extinct species.
'Going the Way of the Dodo: De-Extinction, Dualisms, and Reframing Conservation' by Alejandro E. Camacho in (2015) 92 Washington University Law Review 849 comments
De-extinction, a suite of selective breeding or biotechnological processes for reviving and releasing into the environment members or facsimiles of an extinct species, has been the subject of a recent surge of analysis in popular, scientific, and legal literature. Yet de-extinction raises more fundamental questions about the relationship between humans and nature and about the more and less useful ways that the law serves to navigate that relationship. Unfortunately, the endangered species, invasive species, and public land management laws likely to govern the revival and introduction of de-extinct species largely remain premised on an understanding of nature as static and easily divisible from human activity. In these contexts, the law habitually privileges and even actively promotes what it identifies as natural and native over the unnatural and exotic. 
Through the example of de-extinction, this article illustrates the limitations of the law’s reliance on these crude dualisms. Currently, de- extinct species will often be obstructed as non-native and introduced (evenif they might promote ecological function in a particular area) and may be allowed or promoted in locations they used to exist (even if likely to cause ecological damage). De-extinction illustrates how policymakers need to reformulate natural resources law to be less dependent on these strict dualities. Instead, the article argues in favor of cautious risk assessment that acknowledges the dynamism of nature and humanity’s indivisibility from it.
'De-extinction and precision conservation' by William M. Adams in (2016) Progress in Human Geography argues
 Extinction has long been a central concern in biodiversity conservation. Today, de-extinction offers interesting possibilities of restoring charismatic species and ecosystem function, but also risks and costs. Most de-extinction depends on genetic engineering and synthetic biology. These technologies are also proposed for use in ‘gene tweaking’ in wild species to enhance their chance of survival. Within conservation, the resulting debates pit an optimistic world of high-tech ‘precision conservation’ against a more conventional vision of biodiversity conservation achieved primarily through protected areas. De-extinction is a fashionable idea that brings the complex debates about the ethics and wisdom of genetic engineering to a central position within conservation science.

12 December 2015

DTC Genomics regulation in Europe

'Current developments in the regulation of direct-to-consumer genetic testing in Europe' by Louiza Kalokairinou, Heidi C. Howard and Pascal Borry in the (2015) 15(2-3) Medical Law International 97-123 comments
Over the past years, direct-to-consumer (DTC) genetic testing has provoked controversy regarding its still questionable risks and benefits. The safety and performance of such devices, when entering the European market, are currently regulated by the Directive 98/79 EC of the European Parliament and of the Council on in vitro diagnostic medical devices. In September 2012, a new Regulation was proposed to replace this Directive, and the legislative process is still ongoing. This article presents the main points of the European Commission’s proposal for the new Regulation and the subsequent amendments voted by the European Parliament, aiming to evaluate the potential contribution of the proposal for a more effective regulation of DTC genetic testing in Europe. In this regard, the proposal seems to enhance the current regulatory framework by further elucidating the scope of the Regulation and by establishing a risk-based classification system that guarantees increased pre-market scrutiny of the tests. Furthermore, the proposal attempts to establish higher safety and performance requirements and to enhance transparency. In addition, the European Parliament introduced amendments according to which appropriate genetic counselling is required in the context of genetic tests, and such tests are classified as prescription only, banning, at the same time, their DTC advertising. These developments have already provoked controversy among stakeholders and, if eventually adopted, they may lead to a radical change in the European DTC genetic testing landscape. In this light, the political decisions that will be taken imminently will be determinant.
In introducing the article they state
Even though proponents of [direct-to-consumer (DTC) genetic] tests claim that they enhance the autonomy of consumers and promote their education regarding genetics, there is great concern among policymakers, professional groups and scientists regarding various ethical, social and regulatory aspects associated with such services. These concerns include, among others, issues regarding the questionable validity and utility of DTC genetic tests and the often poor and misleading information accompanying them, as well as concerns regarding the privacy of results and the possible stigmatization and discrimination resulting from a privacy breach. In addition, it is feared that the absence of adequate medical supervision and genetic counselling in this context may lead to inappropriate health decisions and unnecessary burden on the healthcare system if consumers request and obtain unnecessary consultations with medical professionals. Moreover, the effectiveness of regulation regarding DTC genetic testing has been widely debated, both in Europe and in the United States, and it is further complicated by such tests being mostly marketed through the Internet, rendering the enforcement of relevant legislation more challenging.
The aim of this article is to outline exactly how regulation of DTC genetic testing in Europe is likely to be affected by the proposed Regulation on In Vitro Diagnostic Medical Devices, which is currently under discussion in a trialogue between the European Parliament, the Council of the European Union (EU) and the European Commission. More specifically, after providing a brief introduction to the historical background of the proposed regulation, the proposed amendments will be summarized and assessed, focusing especially on the scope of protection provided by the proposed regulation, the risk classification of devices, the regulation of self-tests, clinical evidence and clinical utility, transparency and truth in labelling, canalization and advertising of genetic tests and, finally, regarding genetic counselling and informed consent.
The authors conclude
Adopting the current proposed Regulation and the amendments introduced by the Parliament will mean that a very broad range of genetic tests, including tests for both health-related and lifestyle purposes may fall within the scope of the Regulation, regardless of the jurisdiction in which the manufacturer is established, as long as they are offered to people residing in EU Member States. Furthermore, DTC genetic tests will be subject to additional requirements set for self-testing devices, whilst, according to the new risk-based classification system, (DTC) genetic tests will have to go through a pre-market assessment by independent notified bodies. In this respect, the proposed Regulation and the amendments voted by the European Parliament improve upon the current regulatory framework and may raise the standards of safety and performance for genetic tests entering the European market. Nevertheless, the lack of definition and requirements for the assessment of clinical utility might render its inclusion in the pre-market evaluation of IVD devices meaningless and/or burdensome for the notified bodies.
Furthermore, the European Parliament’s amendments make mandatory the involvement of health-care professionals in the process of genetic testing by requiring appropriate genetic counselling for every type of genetic test as well as by classifying all genetic tests as prescription only and banning DTC advertising for such tests. A full implementation of these provisions would mean, in theory, that genetic testing companies will have to redirect the provision of their products and their marketing campaigns to health-care professionals since directly accessing consumers in the EU will be illegal. In this way, the amendments attempt to bring genetic testing back to the traditional, physician-centred model of healthcare, despite the recent shift to a model focusing on consumer empowerment, as initiated by DTC genetic testing companies.
Even though requiring genetic counselling and the involvement of health-care professionals in the genetic testing process might mitigate the risks stemming from particular subsets of tests, the competence of the EU to regulate clinical practice in such detail has been contested. There are concerns that the very broad definition of genetic tests provided by the proposal, in combination with particularly strict requirements for pre-market approval, without taking into account risks and benefits associated with each type of test, would be overly restrictive and stifle innovation and competitiveness in Europe. Hence, it may be important for the restrictions imposed on the tests to be proportionate with the potential risks stemming from such tests in order to achieve an appropriate balance between the protection of public health and the right of the individuals for self-determination and access to their genetic information.
As a general comment, it may be noted that the amendments introduced by Parliament emphasize medical supervision and genetic counselling in order to address some of the risks potentially stemming from DTC genetic testing. At the same time, an opportunity to establish robust criteria of clinical validity is being missed, whilst the inclusion of clinical utility in the pre-market assessment is not likely to have any impact on DTC genetic tests. In this regard, it may be argued that the medical prescription model and the mandatory pre- and post-test genetic counselling have been valued more than ensuring the good quality of the tests. This policy choice might prove to be problematic since it shifts responsibility to health-care professionals who may often not be adequately equipped to assume the role of gatekeepers.
The Council, on the other hand, seems to move closer to the position of the Commission and attempts to ensure that IVD devices are thoroughly assessed when entering or being put into service in the European market and they are adequately surveyed after that.
When it comes to DTC genetic testing, the approaches adopted by the Parliament and the Council are divergent. It remains to be seen how this opportunity to change the DTC genetic testing landscape will be handled on the political level and on which side the pendulum will settle.
Finally, it should be kept in mind that the Regulation is still a long way from implementation. A trialogue among the Commission, the Parliament and the Council started in October 2015. This procedure might last for several months. Taking into account that the proposal of the Parliament provides a 3-year transition period before implementation of the Regulation, whilst the Commission and the Council propose a 5-year period, and given the rapid developments in the DTC industry, it is not clear to what extent the reforms will impact the DTC genetic testing market.
'Should Extinction be Forever? Restitution, Restoration, and Reviving Extinct Species' by Christian Diehm in (2015) 37(2) Environmental Ethics comments
 “De-extinction” projects propose to re-create or “resurrect” extinct species. Perhaps the most common justification offered for these projects is that humans have an obligation to make restitution to species we have eradicated. There are three versions of this argument for de-extinction—one individualistic, one concerned with species, and one that emphasizes ecological restoration—and all three fail to provide a compelling case for species revival. A general critique of de-extinction can be sketched that highlights how it can both facilitate inattentiveness to biological and ecological boundaries and foster a managerial mentality toward the natural world.
'Towards a Law of the Mammoth? Climate Engineering in Contemporary EU Environmental Law' (Tilburg Law School Research Paper No. 07/2015) by Han Somsen comments
 In an article that made waves when it was first published in 1996, judge Easterbrook scorned the idea that the technological reality of cyberspace justified talk about or a need for ‘Cyber Law’. Just as there is no need for a ‘Law of the Horse’ merely because horses give rise to legal claims, he argued, conventional legal principles and reasoning are sufficiently accommodating to absorb new legal challenges that arise in the wake of cyberspace. We may likewise doubt the need for a ‘Law of the Mammoth’, even though technologies emerge that harbour the prospect of bringing back the woolly mammoth from extinction, reversing climate change, and creating new life forms. Cyber Law is now firmly established, of course, and Easterbrook also appears to have lost the academic debate from the likes of Lawrence Lessig. That fact notwithstanding, the onus to show that the time has come for a Law of the Mammoth clearly is on those staking the claim. 
The purpose of this article essentially is to prepare the ground for that argument, with particular but by no means exclusive reference to climate engineering. Instead of framing the question as one of a confrontation between environmental law and climate engineering, a multitude of technologies instrumental in intentionally enhancing the environment suggests that it is appropriate more generically to consider the introduction of a novel concept in environmental law that captures the essence of such efforts. In the same vein as ‘human enhancement’ has come to be distinguished from ‘medical therapy’, in view of novel environmental policy uses of technologies it is submitted that we should consider the virtues of distinguishing environmental ‘enhancement’ from environmental ‘improvement’.