scholarly journals Toward the definition of specific protection goals for the environmental risk assessment of chemicals: A perspective on environmental regulation in Europe

2016 ◽  
Vol 13 (1) ◽  
pp. 17-37 ◽  
Author(s):  
A Ross Brown ◽  
Graham Whale ◽  
Mathew Jackson ◽  
Stuart Marshall ◽  
Mick Hamer ◽  
...  
2019 ◽  
Vol 18 (1) ◽  
Author(s):  
John L. Teem ◽  
Aggrey Ambali ◽  
Barbara Glover ◽  
Jeremy Ouedraogo ◽  
Diran Makinde ◽  
...  

Abstract Background Gene drive mosquitoes have been proposed as a possible means to reduce the transmission of malaria in Africa. Because this technology has no prior use-history at this time, environmental risk assessments for gene drive mosquitoes will benefit from problem formulation—an organized and ordered process to identify protection goals and potential pathways to harm to the environment, or animal or human health. Recognizing this need, the New Partnership for Africa’s Development (NEPAD), with support from African and international partners, organized four regional consultative workshops in Africa to initiate this process. Methods The workshops were attended by a diverse set of participants and stakeholders, including scientists, ethicists, health professionals, government regulators in the fields of environment health and biosafety as well government policymakers, who met for 4 days to deliberate on protection goals and pathways relevant to the use of gene drive mosquitoes for malaria control. The goal of the workshops was not to produce a comprehensive and detailed environmental risk assessment of gene drive mosquitoes, but rather to introduce problem formulation as a tool to the stakeholder community, and to serve as a starting point for conducting systematic environmental risk assessments in the future, identifying protection goals related to gene drive mosquitoes that are particular to African stakeholders. Results Participants in the workshops frequently identified human health and biodiversity as being relevant broad protection goals. Results of the deliberations provide insight into the concerns of African participants at an early stage in the development of gene drive organism/products that should be instructive to developers using this technology. Conclusions In general, the African participants of the consultations had a precautionary perspective with regard to environmental risk assessment of gene drive technology. As gene drive technology develops, protection goals will become further refined and candidate products will be further defined. These workshops represent only the beginning of a continuing process that will ultimately inform environmental risk assessment for gene drive mosquitoes to control malaria in Africa.


2020 ◽  
Vol 15 ◽  
pp. 1-29 ◽  
Author(s):  
Marion Dolezel ◽  
Christoph Lüthi ◽  
Helmut Gaugitsch

Gene drive organisms (GDOs) have been suggested as approaches to combat some of the most pressing environmental and public health issues. No such organisms have so far been released into the environment, but it remains unclear whether the relevant regulatory provisions will be fit for purpose to cover their potential environmental, human and animal health risks if environmental releases of GDOs are envisaged. We evaluate the novel features of GDOs and outline the resulting challenges for the environmental risk assessment. These are related to the definition of the receiving environment, the use of the comparative approach, the definition of potential harm, the stepwise testing approach, the assessment of long-term and large-scale risks at population and ecosystem level and the post-release monitoring of adverse effects. Fundamental adaptations as well as the development of adequate risk assessment methodologies are needed in order to enable an operational risk assessment for globally spreading GDOs before these organisms are released into environments in the EU.


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