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Table 1 Comparison of risk and impact assessments relevant to gene drive applications

From: Recommendations for environmental risk assessment of gene drive applications for malaria vector control

 

Strategic Environmental Assessment [SEA]

[16, 17]

Environmental & Social Impact Assessment [ESIA]a

[18]

Environmental Risk Assessment [ERA]

[7, 12, 54, 55]

Purpose

Supports political and policy level decision-making

Supports decision-making on specific projects

Supports decision-making on specific products

Scope

Policy, plans and programmes

Specific projects

Specific projects

Legislative basis

National and EU environmental regulations

National and EU environmental regulations

International law and national biosafety legislationb

Guidance

Extensive documentation, including from WHO [75], UNEP [76, 77], World Bank [78], OECD [79, 80] and EU [81]

Extensive documentation, including from WHO [82], World Bank [78], International Finance Corporation of the World Bank Group [83], African Development Bank Group [84], UNEP [76, 77] and EU [85]

Extensive documentation, including from CBD [11], EFSA [7, 12], NASEM [9] and WHO [8]

Number of exercises envisaged

Single for a general class of intervention (e.g. low threshold gene drive for malaria control)

Single for a specific release at specific location but likely to be multiple based on specific context and geography

Likely to be multiple, arising from different sponsors and assigned assessors

Sponsor

Developer

Developer

Developer; Organization independent

of developer; Regulatorc

Assessor

Organization independent

of developer

Organization independent

of developer

Developer; Organisation independent

of developer; Regulatorc

Extent of engagement

Public facing and participative; Stakeholders engaged throughout processd; Data collection by interviews, focus groups, and desk-based work

Public facing and participative; Stakeholders engaged throughout processd, Data collection by interviews, focus groups, and desk-based work

Principally agency-applicant interaction; Engagement with broad experts on technical issues and parameters at discrete stages of assessment; Stakeholder engagement in problem formulation and model and scenario developmente

Parameters

Sustainability in relation to social, economic, health, environment endpoints and cumulative impacts, examination of alternatives to proposed intervention

Environmental, social, economic, and health endpoints, drawing on SEA and ERA endpoints

Biosafety endpoints on environment and health

Analysis type

Qualitative

Qualitative

Probabilistic; Qualitative; Combination of both of the aforementionedf

Role of post-release monitoring

None

Monitoring and audit as set out in Environmental and Social Management Plan to mitigate negative or enhance positive impacts of application

Post-Marketg Environmental Monitoring to assess risks and uncertainties identified and confirm hypotheses in the ERA, including on temporal or spatial scales and reversibility [12]

  1. aAlso known as Environmental, Socioecomonic and Health Impact Assessment (ESHIA) or Environmental Impact Assessment (EIA) in some jurisdictions
  2. bThe Cartagena Protocol on Biosafety to the Convention on Biological Diversity (CBD) is an international agreement that has entered into force in 173 countries, with notable exceptions such as Argentina, Australia, Canada, Israel and the United States of America
  3. cFor early gene drive applications, it is anticipated that all three types of potential sponsor and assessor are likely to be involved
  4. dFor gene drive applications, these assessments are anticipated to take place over circa two to three years
  5. eIn the EU, there is a mandatory engagement with the public for all GMOs that are environmentally released. The engagement is in the form of commenting on draft decisions. In this article, in ERA of gene drive applications we recommend wider engagement of experts and publics than has previously been the case with ERAs for conventional LMOs or GMOs (see Recommendations One, Four, Seven, Eight and Nine)
  6. fIn this article, we recommend using a combination of probabilistic and qualitative approaches to ERA for gene drive applications (see Recommendation Seven)
  7. gIn the case of gene drive applications, there would likely be a monitoring requirement even if the release was for pre-market trials