Asserting a Role for Indigenous Peoples and Local Communities in Decision-Making
Gene drives can have cascading effects on ecosystem flora and fauna on which indigenous peoples depend for subsistence and cultural identity. Because of their intimate and historical relationships to resources and landscapes, these communities possess knowledge that should be respected and considered. These communities must have an active role in decision-making. Potential avenues include engagement in international conventions and national, state and local laws, regulations and policies, as well as scientific and professional codes of conduct.
International Decision-Making
International decision-making is especially significant due to the global nature of gene drive research. A recent report by a committee convened by the US National Academy of Sciences, Engineering, and Medicine (NASEM 2016), Gene Drives on the Horizon, outlines three categories of governance mechanisms for international agreements: policy, international coordination and cooperation, and formal treaties. Respectively, an example of the first type is the US-UK Agreement for Scientific and Technological Cooperation, the second the World Health Organization’s (WHO’s) Guidance Framework for Testing Genetically Modified Mosquitoes (GMM), and the third the UN Convention on Biological Diversity (CBD). Although they do not explicitly address gene drive research, the latter two agreements are particularly relevant, and “discussions are under way [to address gene drive research]” (NASEM, 2016).
The WHO’s GMM Framework contains normative principles for evaluation that may be adapted to gene-drive modified organisms, and the WHO also manages expert panels to encourage self-governance. For example, the Vector Control Advisory Group (VCAG) provides “expert advice to investigators on the evaluation and development of vector control products and strategies,” with critiques and comments publicly available to enhance public engagement.
The CBD is “the main international regulatory instrument governing the development and use of genetically modified organisms,” with 193 states parties and three objectives: conservation of biological diversity; sustainable use of the components of biological diversity; and fair and equitable sharing of the benefits arising out of the utilization of genetic resources (NASEM, 2016). It is implemented through its two protocols, the Cartagena Protocol on Biosafety and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization.
Extensions of the powers of the Convention in the governance of gene drive research, and, relatedly, synthetic biology, are being explored… In 2015, the Open-ended Online Forum on Synthetic biology was held to inform work of Ad Hoc Technical Expert Group. For the Forum, the Conference of the Parties (COP) invited Parties, other governments, relevant international organizations, indigenous and local communities, and other relevant stakeholders to submit information on seven topics related to synthetic biology to the Executive Secretary. The Forum demonstrated that there is a broad range of differing opinions, between and within nations, about the operation of the Convention, and about how its current provisions would relate to the governance of synthetic biology (CBD, 2015), and by extension to gene drives (NASEM, 2016).
A key challenge in applying the Convention and the Protocols to gene drive research is “the way in which individual countries choose to implement their provisions, rather than in the provisions themselves” (NASEM, 2016). Additionally, the US is not a Party to the Cartagena Protocol, constituting a significant gap in international governance because the US “does not have a clear policy for collaborating with other countries with divergent systems of governance, especially when such countries may, in fact, lack the capacity to assess the safety of gene drive research, undertake public engagement and societal dialogue, and maintain regulatory institutions” (NASEM, 2016).
National Decision-Making
In the US, “regulation of gene-drive modified organisms will most likely fall under the Coordinated Framework for the Regulation of Biotechnology,” which divides regulatory authority across the US Food and Drug Administration (FDA), the US Department of Agriculture (USDA), and the US Environmental Protection Agency (EPA), and may also include the Centers for Disease Control and Prevention (CDC) if/when public health is threatened (NASEM, 2016). Although this also does not specifically address issues related to gene drives, the landscape is evolving. “In July 2015, the Obama administration issued a memorandum directing the three participating agencies to update the Coordinated Framework, develop a long-term strategy” (NASEM, 2016), although the status of this under the Trump administration is unknown.
The specific governance mechanisms available to agencies may vary according the phase of product testing. For example, “laboratory experiments on gene drive technologies are overseen at the institutional level through Institutional Biosafety Committees (IBCs),” which “are the primary oversight mechanism for research involving genetic modification at National Institutes of Health (NIH)-funded institutions” (NASEM, 2016). This US system “to govern biotechnology research in the laboratory include[s] professional guidelines, institutional oversight committees that, in most cases, are accountable to federal agencies, and a process through which novel and controversial research can be considered by federal authorities before it proceeds. These systems are likely to have the flexibility to adapt well to gene drive technologies” (NASEM, 2016).
For the later phases of product testing, however, “the current US regulatory system does not particularly account for the intentional spread of genetically modified organisms or their potential persistence in the environment. In addition, it is not clear how existing biotechnology regulations apply to gene drive technologies” (NASEM, 2016).
All US federal actions are subject to review under the National Environmental Policy Act (NEPA), which require agencies to assess potential impacts of those actions on the environment. The NASEM report makes two important points in describing the potential role of NEPA in the analysis of environmental effects of gene-drive modified organisms:
First … while the preparation of an EA [environmental assessment] requires the assessment of potential impacts of the research activity, an EA does not require an ecological risk assessment. Thus, the necessary evidence to quantitatively estimate risk may not be gathered for environmental assessment procedures normally performed under NEPA.
Second, NEPA includes provisions for some public engagement. For environmental assessments, agencies sometimes take into account public views in the form of a public hearing or comment period. NEPA explicitly requires public consultation for an EIS [environmental impact statement]. Through mandatory public hearings and comment periods, members of the public can express their views about the relative value of potential benefits and harms, and concerns about assumptions built into the environmental impact statement. Thus, through provisions requiring transparent decision making and public input of various kinds, NEPA affords stakeholders and the general public the opportunity to participate directly in governance (NASEM, 2016).
Regarding native peoples in the U.S., President Obama re-affirmed Executive Order 13175 (November 6, 2000) in his Presidential Memorandum regarding tribal consultation (November 5, 2009), clarifying that “executive departments and agencies (agencies) are charged with engaging in regular and meaningful consultation and collaboration with tribal officials in the development of Federal policies that have tribal implications, and are responsible for strengthening the government-to-government relationship between the United States and Indian Tribes.”
In recognition of the sovereignty of federally recognized Indian Tribes (Indian Tribes) and their special relationship with the U.S. Government, federal agencies are required to engage with Indian Tribes in formal government-to-government consultation in advance of proposed actions or undertakings. Tribal consultation involves relationship-building and is most effective when federal agencies approach the process from that perspective. President Obama’s memorandum on tribal consultation states, “History has shown that failure to include the voices of tribal officials in formulating policy affecting their communities has all too often led to undesirable and, at times, devastating and tragic results. By contrast, meaningful dialogue between Federal officials and tribal officials has greatly improved Federal policy toward Indian tribes. Consultation is a critical ingredient of a sound and productive Federal-tribal relationship” (MPA FAC, 2011: 12).
Although this pertains to specifically to federally-recognized tribes, leadership and staff of many federal agencies recognize the importance of engaging and collaborating with indigenous communities across the spectrum of recognition status, and are able to do so in their activities and practices. Additionally, the National Historic Preservation Act (NHPA) “requires federal agencies to meaningfully consider the potential effects of federally assisted or permitted projects on properties included in, or eligible for inclusion in, the National Register of Historic Places. Meaningful consideration includes consultation with all concerned parties, not just State or Tribal preservation offices. The Section 106 process of the NHPA is triggered by the presence or possibility of potentially eligible, eligible, or listed NRHP properties that may be affected by the proposed project” (MPA FAC, 2011: 10).
The connection of gene drive research to NHPA is that ecosystem-based management requires understanding the human dimensions operating within ecosystems, rather than using the separated vantage points of “natural” and “cultural” resources, and furthermore, a cultural landscape approach examines the relationships among living and non-living resources, and their environment (MPA FAC, 2011: 20). Many natural resources and sites have cultural value to indigenous communities, which may include traditional knowledge and practices important for subsistence and cultural identity. Gene drive activities that may impact these resources and places must necessarily engage these communities in decision making.
Sub-National Decision-Making
State and local laws, regulations and ordinances also contribute to the complex regulatory environment for outdoor research with gene drive constructs in animals. Of greatest import may be the state-level environmental laws (e.g., the California Environmental Quality Act), and state and local notification requirements for the release of genetically modified organisms (e.g., Virginia Biotechnology Research Act Sec. 2.2-5500-5509). Gene-drive modified organisms released into the environment have the potential for transboundary movement. Governance will require communication and coordination between adjacent countries or states with separate regulatory jurisdiction. Both regional and national rules and regulations would apply. Laws and regulations at the country and local levels (nation, state, province, county, or lesser levels of jurisdiction control, such as a village) are also likely to play a significant role in the governance of the release of gene-drive modified organisms and their potential transboundary movement. The phase of staged environmental release, in particular, will have direct effects and implications for communities near and adjacent to the location of release, animating the issue of community participation in research governance (NASEM, 2016).
As discussed above, gene drives implemented in an ecosystem can have cascading effects on flora and fauna on which communities depend for subsistence and cultural identity. Because of their intimate and historical relationships to resources and landscapes, local and indigenous peoples possess knowledge that should be respected and considered by researchers. These communities must therefore have an active role in decision-making in the process.
While engagement does not guarantee an outcome that will be celebrated by all, procedures that demonstrate good-faith efforts toward respectful listening, creative compromise, and flexible practice contribute to a sense of “procedural justice.” According to Ottinger (2013), “procedural justice, or the ability of people affected by decisions to participate in making them, is widely recognized as an important aspect of environmental justice” (p. 250), demanding that we foster “ongoing opportunities for communities to consent to the presence of hazards as local knowledge emerges and scientific knowledge changes” (p. 251). Regulatory frameworks may provide convening authority for engagement, but are often insufficient to achieve procedural justice. Where such laws are not in place, which may be a common context for field trials of gene drives in low-income countries, decision making processes may need to be developed to fit the political and cultural context—a lack of regulatory requirements demanding engagement does not relieve developers and scientists from the ethical obligation to engage public audiences. Examples might include ad hoc community meetings led by village elders or consultation with organized constituencies—furthering democratic goals regardless of the broader political context associated with the field trial's location (NASEM, 2016).
The NASEM report concludes that “there is a need to reach international agreement on the adaptation of existing governance approaches in the United States and other countries to cope with the distinguishing features of gene drives, particularly their intentional persistence upon release to the environment” (2016). The committee’s final two governance recommendations are:
Recommendation 8-9: To ensure the long-term safety of human health and the environment, decision makers should consider a large toolbox of policies, including regulatory and non-regulatory mechanisms, for the rapidly developing field of gene drive research.
Recommendation 8-10: Research institutions, regulators, and funders should revisit international regulatory frameworks, national laws, non-governmental policy, and professional codes of conduct on research and the release of genetically modified organisms to determine whether and how they may be applied to the specific context of gene drive research, particularly with regard to site selection issues, capacity building for responsible and inclusive governance systems, scientific and post release surveillance, and stakeholder engagement (NASEM, 2016).