Changes will make Australian gene technology regulations more relaxed than New Zealand and Europe but tighter than the US. Some scientists urge caution and question the arguments used to support deregulation of the most common form of gene editing, but the food authority has yet to decide on safety assessment and labelling of gene-edited foods.
In November of 2017, an interdisciplinary panel discussed the complexities of gene drive applications as part of the third Sackler Colloquium on “The Science of Science Communication.” The panel brought together a social scientist, life scientist, and journalist to discuss the issue from each of their unique perspectives. This paper builds on the ideas and conversations from the session to provide a more nuanced discussion about the context surrounding responsible communication and decision-making for cases of post-normal science. Deciding to use gene drives to control and suppress pests will involve more than a technical assessment of the risks involved, and responsible decision-making regarding their use will require concerted efforts from multiple actors. We provide a review of gene drives and their potential applications, as well as the role of journalists in communicating the extent of uncertainties around specific projects. We also discuss the roles of public opinion and online environments in public engagement with scientific processes. We conclude with specific recommendations about how to address current challenges and foster more effective communication and decision-making for complex, post-normal issues, such as gene drives.
In recent years, new genome editing technologies have emerged that can edit the genome of non-human animals with progressively increasing efficiency. Despite ongoing academic debate about the ethical implications of these technologies, no comprehensive overview of this debate exists. To address this gap in the literature, we conducted a systematic review of the reasons reported in the academic literature for and against the development and use of genome editing technologies in animals. Most included articles were written by academics from the biomedical or animal sciences. The reported reasons related to seven themes: human health, efficiency, risks and uncertainty, animal welfare, animal dignity, environmental considerations and public acceptability. Our findings illuminate several key considerations about the academic debate, including a low disciplinary diversity in the contributing academics, a scarcity of systematic comparisons of potential consequences of using these technologies, an underrepresentation of animal interests, and a disjunction between the public and academic debate on this topic. As such, this article can be considered a call for a broad range of academics to get increasingly involved in the discussion about genome editing, to incorporate animal interests and systematic comparisons, and to further discuss the aims and methods of public involvement.
Uncertainties can make it hard to plan ahead. But recognising them can help to reveal new questions and choices. What kinds of uncertainty are there, why do they matter for sustainability, and what ideas, approaches and methods can help us to respond to them?
Uncertainty is a concept that defines our times. Every media headline seems to assert that things are uncertain, and increasingly so. Whether it’s climate change, disease outbreaks, economic conditions or political settlements, the same narrative exists.
Helga Nowotny, in her book The Cunning of Uncertainty, argues that “uncertainty is written into the script of life”. But how should we understand ‘uncertainty’, and why does it matter? Are we equipped for responding to seemingly accelerating uncertainties across different policy domains?
A conventional, managerial and technocratic approach is to construct such challenges as risks – where the probabilities of future outcomes are known, or at least can be estimated. The paraphernalia of risk assessment and management are familiar, derived from engineering approaches. These approaches are good for some cases, such as designing a bridge or road, but not for others, where complex socio-ecological dynamics are involved.
New and emerging gene-editing techniques make it possible to target specific genes in species with greater speed and specificity than previously possible. Of major relevance for plant breeding, regulators and scientists are discussing how to regulate products developed using these gene-editing techniques.
Such discussions include whether to adopt or adapt the current framework for GMO risk governance in evaluating the impacts of gene-edited plants, and derived products, on the environment, human and animal health and society. Product classification or definition is one of several aspects of the current framework being criticized. Further, knowledge gaps related to risk assessments of gene-edited organisms—for example of target and off-target effects of intervention in plant genomes—are also of concern.
Resolving these and related aspects of the current framework will involve addressing many subjective, value-laden positions, for example how to specify protection goals through ecosystem service approaches. A process informed by responsible research and innovation practices, involving a broader community of people, organizations, experts, and interest groups, could help scientists, regulators, and other stakeholders address these complex, value-laden concerns related to gene-editing of plants with and for society.
In July 2018, the European Court of Justice (Case C-528/16) ruled that organisms obtained by directed mutagenesis techniques are to be regarded as genetically modified organisms (GMOs) within the meaning of Directive 2001/18. The ruling marked the next round of the dispute around agricultural genetic engineering in Europe. Many of the pros and cons presented in this dispute are familiar from the debate around the first generation of genetic engineering techniques. The current wave of enthusiasm for the new genetic engineering methods, with its claim to make good on the failed promises of the previous wave, seems to point more to an admission of failure of the last generation of genetic engineering than to a true change of paradigm. Regulation is being portrayed as a ban on research and use, which is factually incorrect, and the judges of the European Court of Justice are being defamed as espousing “pseudoscience”. Furthermore, this highly polarised position dominates the media reporting of the new techniques and the court’s ruling. Advocates of the new genetic engineering techniques appear to believe that their benefits are so clear that furnishing reliable scientific evidence is unnecessary. Meanwhile, critics who believe that the institution of science is in a serious crisis are on the increase not just due to the cases of obvious documented scientific misconduct by companies and scientists, but also due to the approach of dividing the world into those categorically for or against genetic engineering. In this construct of irreconcilable opposites, differentiations fall by the wayside. This article is a response to this one-sided and biased reporting, which often has the appearance of spin and lacks journalistic ethics that require journalists to report on different positions in a balanced and factual manner instead of taking positions and becoming undeclared advocates themselves.
The human population is growing, and as a result we need to produce more food whilst reducing the impact of farming on the environment. Selective breeding and genomic selection have had a transformational impact on livestock productivity, and now transgenic and genome-editing technologies offer exciting opportunities for the production of fitter, healthier and more-productive livestock. Here, we review recent progress in the application of genome editing to farmed animal species and discuss the potential impact on our ability to produce food.
Many technologies, at the time of their inception, have appeared efficacious, safe, and generally a good idea, based on the science at the time. However, in a number of cases, a technology that was once deemed appropriate and desirable has later turned out to be not such a good idea after all. Not only has it failed to deliver on its promises, but it has given rise to environmental damage and negative health impacts. Such technologies have ended up being abandoned or tightly restricted.
There are many examples from history. Asbestos, DDT insecticides, leaded gasoline, and PCBs (polychlorinated biphenyls) in electrical goods were all once hailed as great innovations, but as we grew in our understanding of the mechanisms and complexities of nature’s functioning, we found they could have devastating effects on the health of humans and animals.
We continue to learn from our catastrophic mistakes, but only after serious damage has already occurred to health and the environment. In order to avoid such damage, we need to constantly review each technology from the perspective of the science from which it is derived. Transgenic and genome editing technologies are no exception.
There is no question that our food system is broken. The way we farm, the way we process, sell, buy and eat food has become an exercise in a polluted environment and polluted, undernourished bodies.
Against this backdrop the word ‘organic’ is sometimes waived like a flag – or worn like a magic cloak – that protects us from harm.
The image of organic, of an agricultural system that promotes healthy plants, animals, soil and humans; that emulates and sustains natural systems; that promotes fairness and justice for all living things; and that cares for future generations, is still strong and is still substantially true.
Organic is the most widely-used system that comes closest in practice to genuinely sustainable farming. But it’s under attack on many fronts. In part this is because there can be a large space between image and the business-as-usual reality of food production. Even with the best will in the world, unsatisfactory practices can creep in and, increasingly, corporate and industrial farming and food interests seek to benefit financially from the cache of organic while at the same time belittling, and in some cases ignoring, its core values.
As in many things the US leads the way in this. Hydroponics and concentrated animal feeding operations (CAFOs) have both been allowed in organic foods certified by the United States Department of Agriculture (USDA), in the face of considerable opposition, recently formalised under the banner of the Real Organic Project.
The US has also been blighted by the rise what some call ‘Big Organic’ – an upscaling of organic production that mimics industrial agriculture in its reliance on monocultures, intensive animal rearing and industrial processes. One component of Big Organic is some of the well-established organic brands that have been bought up by large food conglomerates; another is the proliferation of ‘organic’ supermarkets that operate in the same unfair and unsustainable way as their conventional counterparts.
It might be argued that this is simply the consequence of continued and healthy growth in the organic market. Even if that is the case, it is also part of a subtle trend that chips away at the essential nature of organic using mumbo jumbo about the inevitability of market forces and opaque certification.
Genome editing for crop improvement lies at the leading edge of disruptive bioengineering technologies that will challenge existing regulatory paradigms for products of biotechnology and which will elicit widespread public interest.
Regulation of products of biotechnology through the US Coordinated Framework for Biotechnology is predicated on requiring burden of proof that regulation is warranted. Although driven by considerations of newly emerging processes for product development, regulation has, for the most part, focused on characteristics of the biotechnology product itself and not the process used for its development per se.
This standard of evidence and product focus has been maintained to date in regulatory considerations of genome edited crops. Those genome edited crops lacking recombinant DNA (rDNA) in the product intended for environmental release, lacking plant pest or pesticidal activity, or showing no food safety attributes different from those of traditionally bred crops are not deemed subject to regulatory evaluation.
Regardless, societal uncertainties regarding genome editing are leading regulators to seek ways whereby these uncertainties may be addressed through redefinition of those products of biotechnology that may be subject to regulatory assessments. Within US law prior statutory history, language and regulatory action have significant influence on decision making; therefore, the administrative law and jurisprudence underlying the current Coordinated Framework strongly inform policy and governance when considering new plant breeding technologies such as genome editing.
Our purpose in this discussion has been to elaborate how governance within the US legal framework is influencing decisions regarding the regulation of genome edited crops. We do not defend or justify the US regulatory system or suggest any given theory of jurisprudence which is preferable for administration of the Coordinated Framework for Biotechnology. Such considerations would require much more serious examination of the norms that constitute the basis of the US regulatory system.
However, this analysis of the regulatory framework for biotechnology in the US should provide an explanation of the circumstances in law that have led US regulatory agencies, including the USDA, to their current positions for imposing new rules for crops and derived foods developed through genome editing.
Open access .pdf also available.
