Regulation and Policy
Risk assessments, regulation of gene drive, and thought leadership on gene drive policy
Guidance framework for testing of genetically modified mosquitoes
15162WHO, WHO-TDR, 2014-06-01 18:49:50.
As the research progresses, a need has been expressed both within the scientific community and by the public for additional standards and guidance. WHO-TDR and the Foundation for the National Institutes of Health (FNIH) co-sponsored a technical consultation meeting in 2009 to assess current progress and future development of genetically modified mosquito technologies. The meeting was attended by participants from around the world with expertise in molecular biology, medical entomology, ecology, regulatory requirements, ethical, social and cultural issues, as well as staff from WHO, FNIH and other research funders WHO-TDR, 2010). Participants recommended the establishment by WHO and FNIH of a working group to develop a comprehensive guidance framework to provide quality standards for assessing the safety and efficacy of genetically modified xv mosquitoes and addressing legal, ethical, social and cultural issues that arise during their development and deployment. A multidisciplinary effort was subsequently commissioned and over 40 experts recruited to contribute at various stages of development. In accordance with the recommendations, the group included many members who possessed a broad knowledge in their topic areas but were not involved directly in research on GMMs. A draft guidance framework was produced and opened for public comment in late 2012. Responses to public comment have been incorporated into this current version.
Concerning RNA-guided gene drives for the alteration of wild populations
4139Esvelt, KMS, Andrea L.; Catteruccia, Flaminia; Church, George M., eLife, 3:e03401. 2014-01-17 00:00:00.
Gene drives may be capable of addressing ecological problems by altering entire; populations of wild organisms, but their use has remained largely theoretical due to technical; constraints. Here we consider the potential for RNA-guided gene drives based on the CRISPR; nuclease Cas9 to serve as a general method for spreading altered traits through wild populations; over many generations. We detail likely capabilities, discuss limitations, and provide novel; precautionary strategies to control the spread of gene drives and reverse genomic changes. The; ability to edit populations of sexual species would offer substantial benefits to humanity and the; environment. For example, RNA-guided gene drives could potentially prevent the spread of; disease, support agriculture by reversing pesticide and herbicide resistance in insects and weeds,; and control damaging invasive species. However, the possibility of unwanted ecological effects and; near-certainty of spread across political borders demand careful assessment of each potential; application. We call for thoughtful, inclusive, and well-informed public discussions to explore the; responsible use of this currently theoretical technology.
Regulatory experience and challenges for the release of GM insects
4135Beech, C, Journal Fur Verbraucherschutz Und Lebensmittelsicherheit-Journal of Consumer Protection and Food Safety, 9:S71-S76. 2014-01-13 00:00:00.
Genetically modified (GM) insects are a potentially valuable new tool for the biological control of insect pests of humans, animals and plants. Considerable progress has been made recently in transfer of GM insects from the laboratory to release and evaluation in the environment. As with other new genetic technologies, regulatory agencies have often found it challenging to determine the regulatory regime under which they should be evaluated, and have either adapted existing regulatory frameworks or adopted new ones. No country has legislation specifically for GM insects. However, irrespective of the regulatory regime under which they are evaluated, the purpose of their regulation remains the same; to protect human health and the environment. Consequently there are evaluation themes common to their regulatory scrutiny, which are elucidated here. There have also been some challenges and issues encountered during the risk evaluation for field release of GM insects, and this paper will highlight some of these to assist others when considering policy, regulation and assessment of GM insects. Useful regulatory and policy precedents also exist from the regulation of biological control agents and the global protection of plants from pests under the International Standards for Phytosanitary Measures (ISPM) framework. Where countries do not have existing regulations, these evaluation instruments could have the potential to be adapted to form a suitable framework for the assessment of risk for GM insects. Finally, some considerations for future policy and regulation in this area are discussed.
Regulating gene drives
4151Oye, KAE, K.; Appleton, E.; Catteruccia, F.; Church, G.; Kuiken, T.; Lightfoot, S. B. Y.; McNamara, J.; Smidler, A.; Collins, J. P., Science, 345:626-628. 2014-01-09 00:00:00.
Regulatory gaps must be filled before gene drives could be used in the wild
Guidance on the environmental risk assessment of genetically modified animals
16055European Food Safety Authority, European Food Safety Authority, 2013-05-23 20:45:04.
This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds.
Guidance on the environmental risk assessment of genetically modified animals.
4171EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), EFSA Journal, 11:3200. 2013-01-09 00:00:00.
This document provides guidance for the environmental risk assessment (ERA) of living genetically modified (GM) animals, namely fish, insects and mammals and birds, to be placed on the European Union (EU) market in accordance with Regulation (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance for assessing potential effects of GM animals on animal and human health and the environment and the rationales for data requirements for a comprehensive ERA. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds. Each specific area of risk is considered in a structured and systematic way following the aforementioned six steps. In addition, this Guidance Document describes several generic cross-cutting considerations (e.g. choice of comparators, use of non-GM surrogates, experimental design and statistics, long-term effects, uncertainty analysis) that need to be accounted for throughout the whole ERA.
The Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety
5660Secretariat of the Convention on Biological Diversity, Convention on Biodiversity, 2011:1-16. 2011-12-17 18:41:08.
Adopted as a supplementary agreement to the Cartagena Protocol on Biosafety, the Supplementary Protocol aims to contribute to the conservation and sustainable use of biodiversity by providing international rules and procedures in the field of liability and redress relating to living modified organisms, as stated in its Article 1. The Protocol applies to damage resulting from living modified organism which find their origin in a transboundary movement (Article 3). The Supplementary Protocol provides a definition of ‘damage’, referring to an adverse effect on the conservation and sustainable use of biological diversity that is measurable or otherwise observable and significant, taking also into account risks to human health. It provides for an indicative list of factors that should be used to determine the significance of an adverse effect. The Supplementary Protocol requires in Article 4 that a causal link between the damage and the living modified organism be established. States must require the appropriate operator or operators to take response measures in the event of damage resulting from living modified organisms which find their origin in a transboundary movement, as set out in Article 5. The ‘operator’ is defined as any person in direct or indirect control of the living modified organism. The operator must also take response measures where there is a sufficient likelihood that damage will result if timely response measures are not taken. Response measures may also be taken by the competent authority, for example when the operator has failed to do so. In such cases, the competent authority may recover the expenses and costs of such measures from the operator. In addition to the obligation to provide for response measures, Parties may develop civil liability rules and procedures to address damage. The Supplementary Protocol defines ‘response measures’ as reasonable actions to prevent, minimize, contain, mitigate or otherwise avoid damage, as appropriate, or reasonable actions to restore biological diversity. In addition to imposing a requirement for response measures, the Supplementary Protocol obliges Parties to continue to apply existing legislation on civil liability or to develop specific legislation concerning liability and redress for material or personal damage associated with damage to the conservation and sustainable use of biological diversity, as defined in the Supplementary Protocol. As response measures can be imposed by the competent administrative authority, rather than by a judicial body, the Supplementary Protocol is known as having introduced an ‘administrative approach’ to liability and redress.
Progress and prospects for the use of genetically modified mosquitoes to inhibit disease transmission
16052A. A. James, J. D. Mumford, S. L. James and Y. T. Touré, WHO/TDR, 2010-04-01 20:29:20.
The use of genetically modified mosquitoes (GMMs) for disease control has social, economic and ethical implications, so it is important that the World Health Organization (WHO) and its partners provide guidance to countries on these issues. In collaboration with the Foundation for the National Institutes of Health (FNIH), TDR has developed a series of planning meetings on Progress and prospects for the use of genetically modified mosquitoes to inhibit disease transmission. These technical and public consultations will focus on current status and planning for future development.
Problem formulation in the environmental risk assessment for genetically modified plants
4219Wolt, JDK, Paul; Raybould, Alan; Fitzpatrick, Julie W.; Burachik, Moisés; Gray, Alan; Olin, Stephen S.; Schiemann, Joachim; Sears, Mark; Wu, Felicia, Transgenic Research, 19:425-436. 2010-01-17 00:00:00.
Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and approach for analysis. The consistency and utility of ERAs for genetically modified (GM) plants can be improved through rigorous problem formulation (PF), producing an analysis plan that describes relevant exposure scenarios and the potential consequences of these scenarios. A properly executed PF assures the relevance of ERA outcomes for decision-making. Adopting a harmonized approach to problem formulation should bring about greater uniformity in the ERA process for GM plants among regulatory regimes globally. This paper is the product of an international expert group convened by the International Life Sciences Institute (ILSI) Research Foundation.
Ethical, legal and social aspects of the approach in Sudan
25823B. B. El Sayed, C. A. Malcolm, A. Babiker, E. M. Malik, M. A. H. El Tayeb, N. S. Saeed, A. H. D. Nugud and B. G. J. Knols, Malaria Journal, 8:S3. 2009-11-16 10:10:31.
The global malaria situation, especially in Africa, and the problems frequently encountered in chemical control of vectors such as insecticide resistance, emphasize the urgency of research, development and implementation of new vector control technologies that are applicable at regional and local levels. The successful application of the sterile insect technique (SIT) for the control of the New World screwworm Cochliomyia hominivorax and several species of fruit flies has given impetus to the use of this method for suppression or elimination of malaria vectors in some areas of Africa including Northern State of Sudan. The research and development phase of the Northern State feasibility study has been started. Sudanese stakeholders are working side-by-side with the International Atomic Energy Agency in the activities of this important phase. Several ethical, legal and social issues associated with this approach arose during this phase of the project. They need to be seriously considered and handled with care. In this paper, these issues are described, and the current and proposed activities to overcome potential hurdles to ensure success of the project are listed.
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (1)
7354European Parliament,, Official Journal of the European Union L 125, 52:75. 2009-05-21 21:44:10.
Whereas: (1 )Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (3) has been substantially amended several times (4). Since further amendments are to be made, it should be recast in the interests of clarity. (2) Under the Treaty, action by the Community relating to the environment must be based on the principle that preventive action is to be taken and must have as its objective, among other things, the preservation, protection and improvement of the environment and the protection of human health. (3) Measures concerning the evaluation and best use of biotechnology with regard to the environment are a priority area on which Community action should concentrate.
Deployment of innovative genetic vector control strategies: progress on regulatory and biosafety aspects, capacity building and development of best-practice guidance
4220Beech, CV, S.S.; Quinlan, M.M.; Capurro, Margareth L.; Alphey, L.; Bayard, V.; Bouare, M.; McLeod, M.C.; Kittayapong, P.; Lavery, J.; Lim, L.H.; Marrelli, M.T.; Nagaraju, J.; Ombongi, K.; Othman, R.Y.; Pillai, V.; Ramsey, J.; Reuben, R.; Rose, R.I.; Tyagi, B.K.; Mumford, J., AsPac J. Mol. Biol. Biotechnol., 17:75-85. 2009-01-18 00:00:00.
In the ongoing fight against vectors of human diseases, disease endemic countries (DECs) may soon benefit from innovative control strategies involving modified insect vectors. For instance, three promising methods (viz. RIDL® [Release of Insects with a Dominant Lethal], Wolbachia infection, and refractory mosquito technology) are being developed by researchers around the world to combat Aedes aegypti, the primary mosquito vector of viral fevers such as dengue (serotypes 1–4), chikungunya and yellow fever. Some of these techniques are already being extended to other vectors such as Aedes albopictus (the secondary vector of these diseases) and Anopheles mosquito species that transmit malaria. To enable DECs to take advantage of these promising methods, initiatives are underway that relate to biosafety, risk assessment and management, and ethical–social–cultural (ESC) aspects to consider prior to and during the possible deployment of these technologies as part of an integrated vector control programme. This is a brief overview of the objectives and timelines of some of the initiatives being championed by international institutions, including the United Nations Development Programme (UNDP), the World Health Organization (WHO) and the Grand Challenges in Global Health (GCGH) initiative co-sponsored by the Bill & Melinda Gates Foundation.
Use of Genetically Engineered Fruit Fly and Pink Bollworm in APHIS Plant Pest Control Programs: Final Environmental Impact Statement—October 2008
16049USDA/APHIS, USDA/APHIS, 2008-10-01 20:18:57.
The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), in cooperation with several States and foreign countries, is proposing further development of genetically engineered fruit fly species and pink bollworm for use in various applications of the sterile insect technique (SIT) applied to agency invasive plant pest control programs. There have been laboratory and confined field studies to test the efficacy of certain genetic engineering applications that could provide benefits to these programs, but these techniques have not been applied in agency eradication actions or preventive release program (PRP) strategies.
RSPM No. 27 Guidelines for Importation and Confined Field Release of Transgenic Arthropods in NAPPO Member Countries
16041NAPPPO, NAPPO Regional Standards for Phytosanitary Measures, 2007-10-22 20:04:03.
This Standard is designed to provide guidance to NAPPO member countries on the importation and confined field release of transgenic arthropods that are known plant pests or have the potential to affect plant health. This includes transgenic arthropods used for biological control and transgenic beneficial arthropods with the potential to affect plant health. Transgenic arthropod species that are not plant pests, but that may pose a phytosanitary risk because of the genetic modification may also be considered under this Standard. Transgenic arthropods that have undergone a previous pest risk analysis by the regulatory authority of the importing country and been determined not to pose a phytosanitary risk may be exempted from importation requirements under this standard.
Guidelines for the export, shipment, import and release of biological control agents and other beneficial organisms
16037International Plant Protection Convention, Food and Agriculture Organization, 2005-04-01 19:55:50.
This standard provides guidelines for risk management related to the export, shipment, import and release of biological control agents and other beneficial organisms. It lists the related responsibilities of contracting parties to the IPPC, national plant protection organizations (NPPOs) or other responsible authorities, importers and exporters (as described in the standard). The standard addresses biological control agents capable of self-replication (including parasitoids, predators, parasites, nematodes, phytophagous organisms, and pathogens such as fungi, bacteria and viruses), as well as sterile insects and other beneficial organisms (such as mycorrhizae and pollinators), and includes those packaged or formulated as commercial products.
General principles for risk assessment of living modified organisms: Lessons from chemical risk assessment
4310Hill, RAS, C., Environ. Biosafety Res, 2:81-88. 2003-01-08 00:00:00.
Modern biotechnology has led to the development and use of Living Modified Organisms (LMOs) for agriculture and other purposes. Regulators at the national level are increasingly depending on risk assessment as a tool for assessing potential adverse effects of LMOs on the environment and human health. In addition, the Cartagena Protocol on Biosafety, an international agreement expected to enter into force in the near future, requires risk assessment as the basis for decision-making regarding import of some LMOs. While LMO risk assessment is relatively new, there are other risk assessment disciplines which have developed over longer time periods. The field of assessment of the environmental and human health risks of chemicals is particularly well developed, and is similar in application to LMO risk assessment. This paper aims to draw lessons for LMO risk assessment from the vast experience with chemical risk assessment. Seven general principles are outlined which should serve as a useful checklist to guide assessments of risks posed by LMOs.
Malaria Control with Genetically Manipulated Insect Vectors
16035L. Alphey, C. B. Beard, P. Billingsley, M. Coetzee, A. Crisanti, C. Curtis, P. Eggleston, C. Godfray, J. Hemingway, M. Jacobs-Lorena, A. A. James, F. C. Kafatos, L. G. Mukwaya, M. Paton, J. R. Powell, W. Schneider, T. W. Scott, B. Sina, R. Sinden, S. Sink, Science, 298:119. 2002-10-04 19:49:32.
At a recent workshop, experts discussed the benefits, risks, and research priorities associated with using genetically manipulated insects in the control of vector-borne diseases.
Cartagena Protocol on Biosafety to the Convention on Biological Diversity
5665Secretariat of the Convention on Biological Diversity, Convention on Biodiversity, 2000:1-19. 2000-12-17 18:48:56.
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health. It was adopted on 29 January 2000 and entered into force on 11 September 2003.
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