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.

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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.

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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.

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Creating a Sustainable Food Future – A Menu of Solutions to Feed Nearly 10 Billion People by 2050

Publication date: 17/07/2019

As the global population grows from 7 billion in 2010 to a projected 9.8 billion in 2050, and incomes grow across the developing world, overall food demand is on course to increase by more than 50 percent, and demand for animal-based foods by nearly 70 percent. Yet today, hundreds of millions of people remain hungry, agriculture already uses almost half of the world’s vegetated land, and agriculture and related land-use change generate one-quarter of annual greenhouse gas (GHG) emissions.

This synthesis report proposes a menu of options that could allow the world to achieve a sustainable food future by meeting growing demands for food, avoiding deforestation, and reforesting or restoring abandoned and unproductive land—and in ways that help stabilize the climate, promote economic development, and reduce poverty.

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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.

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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.

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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.

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Promises and perils of gene drives: Navigating the communication of complex, post-normal science

Publication date: 16/04/2019

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.

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Detection of food and feed plant products obtained by new mutagenesis techniques

Publication date: 26/03/2019

The European Network of GMO Laboratories (ENGL) has reviewed the possibilities and challenges for the detection of food and feed plant products obtained by new directed mutagenesis techniques leading to genome editing.The focus of this report is on products of genome editing that do not contain any inserted recombinantDNA in the final plant.

It concludes that validation of an event-specific detection method and its implementation for market control will only be feasible for genome-edited plant products carrying a known DNA alteration that has been shown to be unique. Under the current circumstances, market control will fail to detect unknown genome-edited plant products.Several issues with regard to the detection, identification and quantification of genome-edited products are currently based on theoretical considerations only and lack any experimental evidence. Therefore,they will require further consideration.

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The ethics of genome editing in non-human animals: a systematic review of reasons reported in the academic literature

Publication date: 25/03/2019

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.

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