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Review
. 2018 Jul 19;12(Suppl 8):13.
doi: 10.1186/s12919-018-0112-2. eCollection 2018.

Means and ends of effective global risk assessments for genetic pest management

Geoff Turner  1   2 , Camilla Beech  2   3 , Lucia Roda  4
Affiliations
Review

Means and ends of effective global risk assessments for genetic pest management

Geoff Turner et al. BMC Proc. .

Abstract

The development and use of genetic technologies is regulated by countries according to their national laws and governance structures. Legal frameworks require comprehensive technical evidence to be submitted by an applicant on the biology of the organism, its safety to human, animal health and the environment in which it will be released. Some countries also require information on socio-economic and trade impacts. One of the key elements that assists decision-making under those legal frameworks is the use of risk assessments. The risk assessment paradigm of problem formulation based on risk hypothesis, and the assessment of plausible scientific pathways leading to potential environmental and human harms being realised, has been used widely to assess potential risks of genetic technologies to human health and the environment, from crops to mosquitoes. This paper uses the case study of a genetically modified self-limiting olive fly (Bactrocera oleae) for a first deliberate release in Spain to examine the regulatory processes and stakeholders involved in the assessment of risk. It is anticipated that existing risk assessment frameworks are equally applicable to gene drive technologies that may spread and persist in the environment and cross-national borders, but it is the governance structures surrounding the involvement of civil society in regulatory processes that must be administered in a more transparent and defined manner.

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Conflict of interest statement

Not applicable.Not applicable.At the time of writing GT was an employee of Oxitec Ltd. a pioneer of self-limiting biological control solutions for insects that spread disease and cause crop damage. Oxitec is a wholly owned subsidiary of Intrexon Corporation. CB is a former employee of Oxitec Ltd. and a shareholder in Intrexon Corporation. OECD paid for CB attendance at the meeting.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Key steps established in Guidance on the environmental risk assessment of genetically modified animals, European Food Safety Authority [10], Guidance Framework for Testing Genetically Modified Mosquitoes. World Health Organisation [11] alongside of the steps established in Risk Analysis Framework, 2013 Office of the Gene Regulator, Australia [12], and Guidance on Risk Assessment of Living Modified Organisms and Monitoring in the Context of Risk Assessment. UNEP/CBD/BS/COP-MOP/8/8/Add.1, September 2016 [13]
Fig. 2
Fig. 2
Structural representation of the ERA and inter-relation between the different elements. Steps in the ERA are taken from WHO 2014 and EFSA 2013, and specific areas of risk from EFSA 2013. Adapted from EFSA 2013
Fig. 3
Fig. 3
Process of deriving measurement endpoints from broad protection goals in risk assessment. Theoretical example provided for a generic GM insect in the defined risk area of persistence and invasiveness
See this image and copyright information in PMC

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