Why New Genetic Techniques Need to be Stringently Regulated



Dear Friends and Colleagues

Why New Genetic Techniques Need to be Stringently Regulated

Worldwide, governments are under pressure from the biotechnology and agrichemical industries to deregulate products developed using the so-called “new” genetic engineering techniques such as genome editing and gene silencing. A new paper describes how many of the new techniques are not new to science, but because of technical developments can now be applied to more species in less time and for more kinds of traits.

The dramatic change is in the rate at which biotechnologists can alter the genetic constitution of organisms. This is what simultaneously makes the techniques of commercial value and able to produce potentially dangerous products. The authors – all gene technologists themselves – demonstrate that the defining risk is where the technology creates a divergence between the amplification of safety and harm due to human manipulation, rather than in how close the amplified harm is to catastrophic events in nature.

Efforts to deregulate new techniques use terminology and metaphors such as “like nature”, “precise” and “no foreign genes”. The language implies familiarity and safety by association with what occurs in nature or by breeding. Researchers at the University of Canterbury and the Defense Technology Agency, both of New Zealand, demonstrate how these terms are being misapplied to the biochemistry of the new techniques. Exemption of products arising from the use of new techniques do not have the characteristics that pre-suppose them to be as safe as mutations that arise spontaneously in nature or through breeding that does not use gene technology.

The authors compare how emerging tiered (e.g. Norway and Australia) and ‘Responsible Research and innovation’ (RRI) (e.g. EU) regulatory systems could accommodate a ‘critical control points’ approach to regulation guided by a definition of risk that can be uniformly applied to all technologies used in breeding and therefore help harmonise international trade. The critical control points framework would also work for more product-based frameworks such as in Canada and the US, which have adopted them for food safety. RRI is well-adapted for the framework, but all other regulatory frameworks as currently described would require some realignment.

The article, written specifically with policy-makers in mind, is published in the peer-reviewed journal Elementa: Science for the Anthropocene, in a special collection of papers on Gene Editing the Food System.


With best wishes,

Third World Network
131 Jalan Macalister
10400 Penang
Email: twn@twnetwork.org
Websites: http://www.twn.my/and http://www.biosafety-info.net/
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Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies 

Jack A. Heinemann; Deborah J. Paull; Sophie Walker; Brigitta Kurenbach


Biotechnology describes a range of human activities in medicine, agriculture, and environmental management. One biotechnology in particular, gene technology, continues to evolve both in capacity and potential to benefit and harm society. The purpose of this article is to offer a policy bridge from unproductive descriptions of gene technology to useful methods for identifying sources of significant biological and socioeconomic risk in complex food systems. Farmers and the public could be voluntarily and involuntarily interacting with new techniques of genome editing and gene silencing in entirely new ways, limiting the usefulness of previous gene technology histories to predict safety. What we believe is a more consistent, verifiable, and practical approach is to identify the critical control points that emerge where the scale effects of a human activity diverge between risk and safety. These critical control points are where technical experts can collaborate with publics with different expertise to identify and manage the technology. The use of technical terminology describing biochemical-level phenomena discourages publics that are not technical experts from contesting the embedded cultural perspectives and uncertainty in “scientific” concepts and prejudice the risk discourse by ignoring other issues of significance to society. From our perspective as gene technologists, we confront the use of pseudo-scale language in risk discourse and propose an escape path from clashes over whether risks that arise spontaneously (from nature) can be perfectly mimicked by gene technology to a discussion on how to best control the risks created by human activity. Scale is conceptually implicit and explicit in gene technology regulation, but there is no agreement about what scales are most useful to managing risk and social expectations. Both differentiated governance (risk-tiered) and responsible research and innovation models could accommodate the critical control points mechanism that we describe.

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