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

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.

Reproductive interference and Satyrisation: mechanisms, outcomes and potential use for insect control

“…if ongoing releases are required). Whether releasing the Satyr species/population complies with this current and well-established legislation for biological control would need to be carefully assessed (Turner et al 2018) as well as considering biosafety frameworks advised by global authorities on biosecurity and public health (WHO and UNICEF 2010;United Nations 2003;Engineering Biology Research Consortium 2020).…”

“…This may include: If, after examining these factors, Satyrisation remains a viable prospect, it should be considered whether it can synergise with other control methods, such as SIT (Honma et al 2019). Following this, the development of practical control elements would be followed (Table 3) and under guidance from the various regulatory authorities (Vanderplank 1944;FAO/IAEA 2006;Bale et al 2008;Turner et al 2018).…”

Systematic identification of plausible pathways to potential harm via problem formulation for investigational releases of a population suppression gene drive to control the human malaria vector Anopheles gambiae in West Africa

“…It could also be argued that many of the pathways identified here, although plausible, would not, in any event, be expected to occur because the potential harm would be identified during standard product development and result in the strain being eliminated from further advancement towards release. There are already regulatory precedents for the development and successful field release of transgenic mosquito strains [ 20 , 138 ] so that increased vector competence, decreased insecticide sensitivity, broadened tolerances for abiotic conditions, or toxicity and allergenicity of transgenic products are all recognized as having the potential to contribute to harms to health and environmental protection goals. In that respect, many of the pathways identified here are not uniquely drawn from problem formulation.…”

Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives

“…albopictus, Anopheles albimanus and An. stephensi (Fu et al, 2010;Wise de Valdez et al, 2011;Labb e et al, 2012;Slade and Morrison, 2014) and agricultural pests such as the diamondback moth (Plutella xylostella; strain OX4319L; Harvey-Samuel et al, 2015;Bolton et al, 2019), fall armyworm (Spodoptera frugiperda; strain OX4319; Jin et al, 2013), pink bollworm (Pectinophora gossypiella; strains OX3402C, OX4135 and OX4319; Simmons et al, 2011;Morrison et al, 2012;Jin et al, 2013), Mediterranean fruit fly (C. capitata; strain OX3864A; Leftwich et al, 2014;Asadi et al, 2019) and olive fly (Bactrocera oleae; strain OX3097D; Ant et al, 2012;Turner et al, 2018). These strains also express the fluorescent protein marker, DsRed, to permit the effective monitoring of the presence of such strains in the field.…”