We’ve scanned the web to bring together a library of interesting, thought-provoking articles, blogs, reports and academic papers that explore the issue of genetic engineering in food and farming from broader and deeper perspectives. Browse for inspiration or search by theme.

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Brexit food safety legislation and potential implications for UK trade: the devil in the details

Publication date: 31/10/2019

This Briefing Paper from the  UK Trade Policy Observatory and Chatham House examines an array of post-Brexit food safety legislation, covering pesticides, Genetically Modified Organisms (GMOs), food additives and microbiological food safety.

The UK Government has committed itself to incorporating EU law unchanged as the starting point for the post-Brexit regulatory regime. However, EU institutions underpin UK food safety legislation to the extent that detaching UK law and policy making unavoidably constitutes major legislative reform. More concerningly, our analysis suggests that the UK’s post-Brexit food safety rules fall short of the level of protection currently provided by the EU: in some cases, they give ministers broad discretion to make future changes without equivalent scrutiny.

Resource type: article: Web Page

An overview of regulatory approaches to genome editing in agriculture

Publication date: 26/07/2019

The “OECD Conference on Genome Editing: Applications in Agriculture – Implications for Health, Environment and Regulation”, brought together policy makers, academia, innovators and other stakeholders involved in the topic, in order to take stock of the existing research and applications of genome editing, and to thereby provide science-based input to the discussion of the potential impact of genome editing in the context of overarching agricultural and food policies.

The conference provided a timely opportunity for information exchange between scientific experts, risk assessors, policy makers, regulators, private sector innovators and other stakeholders from around the world.

In this paper, we summarise the conference session on the “Regulatory aspects” concerning genome editing (Session 3), during which government representatives from six different countries around the world reported on the policy frameworks pertaining to genome editing in their respective countries, and discussed their specificities, as well as the common issues encountered.

Resource type: Adobe Acrobat (.pdf)

European science community urges rethink on genome editing

Publication date: 25/07/2019

Scientists from the John Innes Centre and The Sainsbury Laboratory today joined colleagues from across Europe in calling for an urgent rethink of EU legislation on Genetically Modified Organisms (GMOs).

An open statement signed by 126 research institutes says that scientists and plant breeders in the European Union should be enabled to use gene editing with CRISPR as a faster and more efficient way of producing food sustainably.

Aimed at the newly-elected European Parliament and European Commission, the statement comes one year to the day that the European Court of Justice (ECJ) ruled that plants obtained by modern forms of mutagenesis, of which gene-editing is an example, are not exempted from the EU GMO Directive.

Resource type: article: Web Page

Roads forward for European GMO policy—uncertainties in wake of ECJ judgment have to be mitigated by regulatory reform

Publication date: 05/06/2019

This article gives an overview of legal and procedural uncertainties regarding genome edited organisms and possible ways forward for European GMO policy. After a recent judgment by the European Court of Justice (ECJ judgment of 25 July 2018, C-528/16), organisms obtained by techniques of genome editing are GMOs and subject to the same obligations as transgenic organisms.

Uncertainties emerge if genome edited organisms cannot be distinguished from organisms bred by conventional techniques, such as crossing or random mutagenesis. In this case, identical organisms can be subject to either GMO law or exempt from regulation because of the use of a technique that cannot be identified. Regulatory agencies might not be able to enforce GMO law for such cases in the long term. As other jurisdictions do not regulate such organisms as GMOs, accidental imports might occur and undermine European GMO regulation.

In the near future, the EU Commission as well as European and national regulatory agencies will decide on how to apply the updated interpretation of the law. In order to mitigate current legal and procedural uncertainties, a first step forward lies in updating all guidance documents to specifically address genome editing specifically address genome editing, including a solution for providing a unique identifier. In part, the authorization procedure for GMO release can be tailored to different types of organisms by making use of existing flexibilities in GMO law.

However, only an amendment to the regulations that govern the process of authorization for GMO release can substantially lower the burden for innovators. In a second step, any way forward has to aim at amending, supplementing or replacing the European GMO Directive (2001/18/EC). The policy options presented in this article presuppose political readiness for reform. This may not be realistic in the current political situation. However, if the problems of current GMO law are just ignored, European competitiveness and research in green biotechnology will suffer.

Resource type: Adobe Acrobat (.pdf)

Gene Drives. A report on their science, applications, social aspects, ethics and regulations

Publication date: 29/05/2019

This lengthy and in-depth report – a collaboration by  Critical Scientists Switzerland (CSS), European Network of Scientists for Social and Environmental Responsibility (ENSSER) and Vereinigung Deutscher Wissenschaftler (VDW) – delves into the science, biology and techniques behind gene drives, their potential applications and risks, as well as the social, ethical legal and regulatory issues that the technology, perhaps inevitably, brings with it.

Resource type: Adobe Acrobat (.pdf)

CRISPR editing of plants and animals gets green light in Australia. Now what?

Publication date: 30/04/2019

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.

Resource type: article: Web Page

Adopt a moratorium on heritable genome editing

Publication date: 13/03/2019

We call for a global moratorium on all clinical uses of human germline editing — that is, changing heritable DNA (in sperm, eggs or embryos) to make genetically modified children.

By ‘global moratorium’, we do not mean a permanent ban. Rather, we call for the establishment of an international framework in which nations, while retaining the right to make their own decisions, voluntarily commit to not approve any use of clinical germline editing unless certain conditions are met.

To begin with, there should be a fixed period during which no clinical uses of germline editing whatsoever are allowed. As well as allowing for discussions about the technical, scientific, medical, societal, ethical and moral issues that must be considered before germline editing is permitted, this period would provide time to establish an international framework.

Thereafter, nations may choose to follow separate paths. About 30 nations currently have legislation that directly or indirectly bars all clinical uses of germline editing, and they might choose to continue the moratorium indefinitely or implement a permanent ban. However, any nation could also choose to allow specific applications of germline editing, provided that it first: gives public notice of its intention to consider the application and engages for a defined period in international consultation about the wisdom of doing so; determines through transparent evaluation that the application is justified; and ascertains that there is broad societal consensus in the nation about the appropriateness of the application. Nations might well choose different paths, but they would agree to proceed openly and with due respect to the opinions of humankind on an issue that will ultimately affect the entire species.

Resource type: article: Web Page

Embracing uncertainty: what are the implications for sustainability and development?

Publication date: 23/01/2019

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.

 

Resource type: Web page URL

Revisiting risk governance of GM plants: the need to consider new and emerging gene-editing techniques

Publication date: 21/12/2018

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.

Resource type: Adobe Acrobat (.pdf)

Policy and governance perspectives for regulation of genome edited crops in the United States

Publication date: 08/11/2018

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.

Resource type: article: Web Page