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A Regulatory Structure for Working with Genetically Modified Mosquitoes: Lessons from Mexico

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Schematic representation of the regulatory pathway for research involving genetically-modified mosquitoes.

Activities of the Project principal investigator and collaborating institutions (oversight collaborating institutions) are coordinated in Mexico by the principal investigator at the Centro Regional de Investigación en Salud Pública (PI/Project Crisp). CRISP also is the regional center of the researchers conducting the work at the field site. The director general of the Instituto Nacional de Salud Publica/National Institute of Public Health (DG/INSP) is the titular head of the collaborating investigators in Mexico. The oversight committee reviews ethical, biosafety, and scientific practices used in the project and makes recommendations to the DG/INSP regarding procedures or adherence of the project participants or internal commissions to appropriate standards. The Bioethics, Research and Biosecurity Commissions are in-house INSP regulatory bodies. CIBIOGEM (Comisión Intersectorial de Bioseguridad de los Organismos Geneticamente Modificados [Intersector Commission for Biosafety of Genetically Modified Organisms]) is the federal-level commission that formulates and coordinates policies in matters related to the biosafety of genetically modified organisms. CIBIOGEM comprises the heads of SEMARNAT (Secretaria del Medio Ambiente y Recursos Naturales [Environmental and Natural Resources Secretary]), SAGARPA (Secretaria de Agricultura, Ganaderia, Desarrollo Rural, Pesca y Alimentación [Agriculture, Livestock, Rural Development, Fisheries and Food Security Secretary]), Cofepris (Comisión Federal para la Protección contra Riesgos Sanitarios [Federal Comision for the Protection against Sanitary risk])/SS (Secretaría de Salud [Secretary of Health]), and a number of others listed in the text. SEMARNAT is the authority to which the Notification (Aviso) was submitted regarding the importation and contained research on genetically modified organisms and that which granted a permit for the collection of native fauna to monitor transgenes. The red arrows show the permit ratification levels and information flow. State-level Sanitary Regulation (IMSS, Instituto Mexicano de Seguro Social [Mexican Social Security Institute]; ISECH, Instituto de Salud del Estado de Chiapas [Chiapas State Health Institute]) monitors and enforces health regulations at this level and ratifies SEMARNAT's permit for genetically modified organisms. County-level Health Committee ratifies ISECH/Cofepris approval for use of genetically modified organisms. Agrarian Reform grants changes in land classification and permission to purchase land and this informs the regional authorities (orange arrow and lines). The Ejido Assembly gives local permission to sell land to INSP and INDAABIN (Instituto de Administración y Avalúos de Bienes Nacionales [Appraisal and Administration of National Property Institute]) grants permission for property purchase by INSP. Catastro (land registry) gives land titles and obras publicas (public works) grants construction permits.

Figure 2