Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values (2016) / Chapter Skim
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8 Governing Gene Drive Research and Applications
8 Governing Gene Drive Research and Applications
Pages 147-176
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From page 147... ...
Do existing governance systems in the United States and abroad adequately promote and protect public health, the environment, and other societal interests? These questions are critical for the future of gene drive research and the potential release of gene-drive modified organisms into the environment.
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TABLE 8-1 Examples of Policy Tools Used to Govern Science and Technology Policy Tool Description Examples Professional Scientific Self- governing mechanisms Hippocratic Oath, the Nuremberg Code; Standards or Norms within the scientific community American Society of Microbiology's Code of Ethicsa Guidelines on the Practice Developed by recognized World Health Organization 2014 of Scientific Research scientific authority Guidance Framework for Testing Genetically Modified Mosquitoes Requirements of Research Enacted in funding agreements US National Institutes of Health Funders and Sponsors rather than through formal law, Guidelines for Research Involving and often implemented at the Recombinant or Synthetic Nucleic Acid institutional level Molecules; Institutional Biosafety Committees; Institutional Animal Care and Use Committees Regional-Level Regulation State or national regulation with California Department of Fish and Game of Science and Technology binding legal force National-Level Regulation Governmental regulation with Human subjects research protections in of Science and Technology binding legal force all federally funded research (i.e., the Common Rule and related regulations) International Agreements Regulatory and non-regulatory International Plant Protection agreements between countries.
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From page 149... ...
Unexpected gene flow is a concern that regulators of current genetically modified organisms seek to mitigate, whereas such flow is expected and even intended for organisms bearing gene drive constructs. In addition gene-drive modified organisms are expected, at least under some conditions, to cross legal boundaries and territories.
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Furthermore, it is important that risk assessments identify, and when possible, account for sources of uncertainty, confounders, and other limitations. The release of gene-drive modified organisms requires predicting the consequences of genetic modifications in complex environments.
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Applying this principle here -- if and when gene drive research moves outside the laboratory, iterative communication with affected communities will be a key part of the risk assessment process. Engagement with broader publics is also essential when important new questions about science and technological governance arise, especially because gene drive technologies are often envisioned to spread beyond the boundaries of discrete human communities.
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However, the concept of function usefully underscores how important it is that regulatory assessments capture the potential harms to human and environmental health posed by the intended uses of gene drives in their social and ecological contexts. Coordinated Framework for the Regulation of Biotechnology In the United States, regulation of gene-drive modified organisms will most likely fall under the Coordinated Framework for the Regulation of Biotechnology.
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IBCs are accountable to the NIH Office of Biotechnology Activities and must implement stipulated guidelines for biosafety known as the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH 2016a)
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As of May 2016, the committee is unaware of formal gene drive research proposals on animals that fall within the regulatory jurisdiction of the Animal Welfare Act. Certain laboratory work on genetically modified plant species and "plant pests" is subject to federal regulations under the Biotechnology Regulatory Services of the Animal and Plant Health Inspection Agency (APHIS)
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Mechanisms in place for international considerations and coordination for field testing or release of gene-drive modified organisms near national borders. In Case Study 6, for example, Palmer amaranth is a weed in the southern United States that can interbreed with related plant species that are cultivated as vegetable crops in Mexico.
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Supplemental permit conditions can include a minimum separation distance to wild relatives and post-harvest monitoring requirements, among others. In 2014, USDA authorized close to 11,000 field trials of more than 12,000 types of genetically modified organisms (Pearson, 2015)
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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.
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Nevertheless, given the desirability of creating space for public engagement, NEPA would seem to be an important regulatory resource for the integration of public values into the governance processes. Examining US Regulation of Gene-Drive Modified Organisms Through Case Studies Which federal agency has the jurisdiction to approve field tests or environmental release of gene-drive modified organisms in the United States?
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NEPA mandates public involvement to include, at a minimum, "reasonable public notice" of environmental assessments, but it is not clear which mechanisms each agency would use in the case of a genedrive modified organism or how public input would be incorporated in the decision making process is not clear. In addition "reasonable public notice" falls short of the engagement that is needed for gene-drive modified organisms (see Chapter 7)
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whose motivation is to cause harm needs to be considered. Given the current understanding of the genetics of vector competence, using gene drives in mosquitoes for malicious intent would seem to be extremely difficult from a technical standpoint, making gene drive research an unattractive proposition compared with other options for causing harm.
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. The impact the Worldwide Threat Assessment may have on gene drive research is not yet known.
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that are relevant for gene drives. GOVERNANCE OF GENE DRIVES IN GLOBAL CONTEXTS International sources of governance that may apply to gene drive research have as much impact on whether and how science develops, as do national the United States' sources of domestic governance.
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Guidance Framework for Testing Genetically Modified Mosquitoes. Neither CBD nor the WHO explicitly addresses gene drive research, although discussions are under way.
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. The Cartagena Protocol was developed primarily because of concerns related to genetically modified crops, with the purpose of addressing potential risks posed by releases of genetically modified organisms into the environment (CBD, 2016)
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Many low- and middle-income countries are signatories to the Cartagena Protocol, which has guided the development of their national regulatory frameworks for governance of living modified organisms, which it defines as any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. Under the Cartagena Protocol, countries are obligated to notify one of the United Nation's International Biosafety Clearing-Houses and any affected nations about activities that may lead to movement of living modified organisms with potential adverse effects on biological diversity or human health.
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. We are at O, appoint where gene drives already necessitate that discussion, whi needs to be t e ich translated into c clear stateme of internatio expectations even if no mech ents onal s hanism exists to enforce regulati ions universallyy.
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In transnational new governance, a number of respected, non-regulatory authorities, such as the International Council for Science, InterAcademy Partnership,6 Academy of Sciences for the Developing World, and the WHO, may have important roles to play in shaping responsible practices for gene drive research internationally. TABLE 8-4 Examples of Transnational Governance Tools in Science That Are Non Regulatory and Non-Legislative Policy Tool Example Transnational regulatory dialogue and networks Working groups of the Organisation for Economic Co-operation and Development International harmonization committees International Conference on Harmonization United Nations declarations International Declaration on Human Genetic Data International principles World Medical Association, Helsinki Principles International scientific assessment Intergovernmental Panel on Climate Change Research guidelines developed by international International Society for Stem Cell Research Guidelines professional scientific societies or other for Embryonic Stem Cell Research non-regulatory science authorities World Health Organization's Guidance Framework for Testing Genetically Modified Mosquitoes World Organisation for Animal Health (OIE)
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larly valuable to low- and m t middle-income countries wh regulatory infrastructure may be lackin but in-count decision ma here y ng try akers/authoriti recog ies niz the need to comply with the Cartagena Protocol. Ma countries, particularly th ze a any hose who lac national or regional gover ck rnance mechan nisms, look to these guidelin to develop their bi nes osaafety governa ance systems.
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This may lead to challenges for considering gene-drive modified mosquitoes and other gene drive modified organisms. The WHO's Special Programme in Research and Training in Tropical Diseases (WHO/TDR)
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Recommendation 8-1: Institutions, funders, and professional societies should provide face to-face instruction and online, open access resources for education and training on the re sponsible practices in gene drive research. Recommendation 8-2: Due to the novel characteristics of gene drives, funding agencies and research institutions should take responsibility to ensure the development of the necessary expertise to assess safety within Institutional Biosafety Committees and their equivalents.
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Recommendation 8-4: The US government should clarify the assignment of regulatory re sponsibilities for field releases of gene-drive modified organisms, including the roles of rele vant agencies that are not currently included in the Coordinated Framework for the Regula tion of Biotechnology. The introduction of novel genetic constructs intended to modify ecosystems increases the uncertainties that gene drives raise in ways that make robust assessment of their risks more critical, but also more difficult.
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Given that the United States is not a Party to the Cartagena Protocol, it is a major gap in international governance that the United States 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. This gap is also significant because many sites for field testing, and ultimately environmental release of gene-drive modified organisms are likely to be outside of the United States.
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2012. Guidance on Risk Assessment of Living Modified Organisms: Risk Assessment of Living Modified Mosquitoes [online]
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2010. Guidelines for Appropriate Risk Governance of Synthetic Biology.
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Regulating gene drives. Science 345(6197)
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2014. The Guidance Framework for Testing Genetically Modified Mosquitoes.
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