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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102413
Status
Published
Date of creation
2011-09-30 21:52 UTC (sortiz@conacyt.mx)
Date of publication
2011-09-30 21:52 UTC (sortiz@conacyt.mx)

This document is also available in the following languages:
Origin of report
Country
  • Mexico
Contact officer for report
Coordinates
Dr. Reynaldo Ariel Álvarez Morales
Secretario Ejecutivo de la CIBIOGEM
Comisión Intersecretarial de Bioseguridad y Organismos Genéticamente Modificados (CIBIOGEM)
San Borja N° 938 Colonia del Valle Delegación Benito Juárez
México, Distrito Federal
Mexico, 03100
Phone:+ 52 55 5575 7618
Fax:+ 52 55 5575 7618 ext 30
Email:secretario.ejecutivo@conacyt.mx
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
ES
Secretaría de Medio Ambiente y Recursos Naturales (SEMARNAT), Secretaría de Agricultura, Ganadería Desarrollo Rural, Pesca y Alimentación (SAGARPA), Secretaría de Salud (SSA), Secretaría de Economía (SE), Secretaría de Educación Pública (SEP), Secretaría de Hacienda y Crédito Público (SHCP), Consejo Nacional de Ciencia y Tecnología (CONACYT), Comisión Nacional para el Conocimiento y Uso de la Biodiversidad (CONABIO), Consejo Consultivo Científico de la Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados (CIBIOGEM) y Secretaría Ejecutiva de la CIBIOGEM.
Submission
10. Date of submission
2011-09-30
11. Time period covered by this report
Start date
2007-09-22
Time period covered by this report
End date
2011-08-31
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is partially in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
ES
El personal con que cuenta México en las diferentes instancias competentes en materia de bioseguridad no es aún suficiente en número y también se requiere personal más capacitado para atender eficaz y eficientemente todos los aspectos de bioseguridad en nuestro país.
Es de destacar  dentro del desarrollo de la normatividad nacional en materia de bioseguridad la publicación del Reglamento de la Ley de Bioseguridad de Organismos Genéticamente Modificados y posteriormente la publicación de las modificaciones a dicho reglamento para la inclusión de un Régimen Especial de Protección del Maíz.
Con relación a este instrumento así como a todos los demás instrumentos normativos, México ha enviado la información al CIISB. Adicionalmente, se presenta también completa en la página de la Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados (CIBIOGEM) en la siguiente liga:
http://www.cibiogem.gob.mx/Norm_leyes/Paginas/default.aspx 
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • No
24. Here you may provide further details on the implementation of Article 5 in your country:
ES
Estos productos están regulados bajo la Ley General de Salud, dado que los excluye explícitamente la Ley de Bioseguridad de Organismos Genéticamente Modificados. Adicionalmente, en el Reglamento de la Ley General de Salud en materia de Insumos para la Salud, se establecen requerimientos para la importación, manipulación, almacenamiento y comercilización, para los productos farmaceúticos. Lo anterior de manera indirecta ya que que estos instrumentos se aplican en lo general e independientemente de que se deriven de organismos vivos modificados (OVMs). Los artículos de la Ley General de Salud que refieren a la importación son: 3 fracción XXIV, 4 fracción III, 17bis, fracción IV, 194 fracción I, 282 bis, 282 bis 1, 282 bis2, Capítulo XIII artículos 283 al 299 y de su Reglamento Título Quinto Importación y Exportación Capítulo I y II Artículos 131 al 152.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • No
28. Here you may provide further details on the implementation of Article 6 in your country:
ES
El transporte de OVMs, así como el tránsito de los mismos por el territorio nacional, siempre y cuando tengan por destino otro país, se encuentran previstos en el artículo 76 de la Ley de Bioseguridad de Organismos Genéticamente Modificados.
La utilización confinada de OVMs es regulada por la misma Ley de Bioseguridad de OGMs a través del instrumento de Aviso. Éste debe ser presentado a las autoridades nacionales competentes correspondientes, por aquellas personas que lleven a cabo actividades de utilización confinada de OVMs con fines de enseñanza o investigación o con fines industriales.
La SEMARNAT y la SAGARPA publicaron el 15 de abril de 2011 en el Diario Oficial de la Federación el "ACUERDO por el que se determina la información y documentación que debe presentarse en el caso de realizar actividades de utilización confinada y se da a conocer el formato único de avisos de utilización confinada de organismos genéticamente modificados". Este instrumento establece las bases para regular el uso y manejo seguros, así como los movimientos transfronterizos, de organismos vivos modificados (u organismos genéticamente modificados) provenientes de la biotecnología moderna con la finalidad de proteger la diversidad biológica y la salud humana de los posibles riesgos que dichos organismos les pudieran representar. El cual contiene los requisitos que por Ley, los particulares deben cumplir para la presentación de las seis modalidades de Aviso.
Dicho formato permitió homologar los requisitos entre dependencias para los siguientes trámites:
I. Aviso de integración de las comisiones internas de bioseguridad.
II. Aviso de la primera utilización de laboratorios o instalaciones específicas de enseñanza o investigación científica y tecnológica en la que se manejen, generen y produzcan organismos genéticamente modificados.
III. Aviso del manejo, generación y producción de organismos genéticamente modificados con fines de enseñanza e investigación científica y tecnológica.
IV. Aviso de la primera utilización de instalaciones específicas en donde se produzcan los organismos genéticamente modificados que se utilicen en procesos industriales.
V. Aviso de la producción de organismos genéticamente modificados que se utilicen en procesos industriales.
VI. Aviso de importación de organismos genéticamente modificados para su utilización confinada.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • More than 10
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • More than 10
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • More than 10
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • More than 10
43. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
  • Yes, always
44. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes, always
45. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Yes, always
46. Has your country informed the notifier(s) and the BCH of its decision(s)?
  • Yes, always
47. Has your country informed the notifier(s) and the BCH of its decision(s) in due time (within 270 days or the period specified in your communication to the notifier)?
  • In some cases only
48. What percentage of your country’s decisions fall into the following categories?
  • Approval of the import/use of the LMO(s) with conditions
91%
  • Approval of the import/use of the LMO(s) without conditions
0%
  • Inform the notifier that the period for communicating the decision has been extended
0%
  • Prohibition of the import/use of the LMO(s)
9%
  • Request for additional relevant information
52%
49. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
  • Yes, always
50. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment:
ES
En función de la regulación en materia de bioseguridad en México, se tienen tres diferentes etapas para la liberación intencional en el medio ambiente de organismos vivos modificados. La liberación al ambiente en etapa experimental, que tiene entre sus propósitos, generar información que sustente la toma de decisiones, en sus etapas inciales ha estado asociada a la aplicación de diversas medidas de bioseguridad, incluidas el limitar o impedir el flujo de genes, así como medidas de monitoreo. La liberación en programa piloto y comercial, dependiendo del OVM puede también condicionarse a la realización de actividades de monitoreo, por ejemplo de resistencia a toxinas. Finalmente todas las liberaciones al ambiente permitidas a la fecha están asociadas a áreas geográficas particulares, asociadas con la evaluación del riesgo que se lleva a cabo caso por caso.
Es importante aclarar que en nuestra legislación no se usa el término notificador si no el de promovente. En aclaración de la pregunta 43, el denominado promovente en la legislación nacional, es quien solicita el permiso de liberación al ambiente, que en su caso incluye el permiso de importación. Por lo anterior no se ha considerado un mecanismo en el que el país exportador directamente sea el que haga la notificación o presente la solicitud a la autoridad competente.
En relación a la pregunta 33, el caso de las acciones de vigilancia, los resultados de dichas acciones no siempre se hacen del conocimiento de las instancias que llevan a cabo parte de la evaluación de riesgos, por lo que el proceso de la comunicación de los riesgos tiene áreas de mejora considerables.
La legislación Nacional establece el requisito de permiso para todas las liberaciones al medio ambiente de OVMs, si se trata de OVMs que se van a importar previo a su liberación al ambiente, una vez otorgado el permiso de liberación, este cumple las funciones de permiso de importación de dichos organismos asociado al sitio o sitios de liberación para los que se haya permitido. De esta forma las importaciones para liberaciones al ambiente de OVMs en México se encuentran asociadas a decisiones caso por caso, y éstas no se restringen al primer movimiento transfronterizo como lo establece el artículo 7, si a todos los movimientos transfronterizos asociados a una liberación al ambiente de OVMs.  Se requiere aclarar que para la pregunta 34, se responde que si, pero se reconoce que el reto para México de ser capaz de detectar e identificar a los diferentes OVM posibles en el ambiente, no es trivial, dado su contexto amplio y diverso que hace que el muestreo requerido sea aún incompleto y requiera fortalecimiento. En el caso de la Secretaría de Salud, como Autoridad Competente, en las preguntas 46, es apropiado mencionar que el esquema de respuesta, conforme a la Ley General de Salud y sus Reglamentos,  incluye, siempre, informar al notificador. En cuanto a la pregunta 48, el porcentaje de las categorias sobre las decisiones, nuevamente, respecto a los productos de uso y consumo humano, varían en relación a lo presentado por las otras instancias, y se presentan a continuación:100% Aprobar la importación con condiciones y el 30% pedir más información.
Adicionalmente relacionado  con la pregunta 46 cabe aclarar que el reporte al CIISB, se refiere a los productos autorizados por la Secretaría de Salud, que no necesariamente corresponden a los movimientos trasfonterizos de estos productos. p                                                             
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • No
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
58. How many LMOs-FFP has your country approved to date?
  • More than 10
59. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
60. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
61. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
  • In some cases only
62. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • In some cases only
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
ES
La Secretaría de Salud quien es la Autoridad Nacional Competente encargada de la evaluación de OVM destinados para uso y consumo humano, animal y para el procesamiento, basa sus resoluciones con la identificación científica y técnicamente sustentada de los posibles riesgos que pudieran generar los OVM-AHAP y de la posibilidad real de afectación a la salud humana.  La Secretaría de Salud niega la Autorización de los OVM-AHAP cuando concluye a partir de una Evaluación de Riesgo, que los OVM-AHAP afectarán negativamente a la salud humana, pudiéndole causar daños  graves o irreversibles.
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • Yes
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • Yes, decision reviewed and changed
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • More than 5
68. Has your country informed the notifier and the BCH of the review and/or changes in the decision?
  • Yes, always
69. Has your country informed the notifier and the BCH of the review and changes in the decision within thirty days?
  • Yes, always
70. Has your country provided reasons to the notifier and the BCH for the review and/or changes in the decision?
  • Yes, always
71. Here you may provide further details on the implementation of Article 12 in your country:
ES
En la Ley de Bioseguridad se establece, respecto al recurso de revisión de permisos de liberación intencional en el medio ambiente, que a su vez sirve como permiso de importación, lo siguiente: la Autoridad Nacional Competente, en cualquier momento y sobre la base de nueva información científica o técnica acerca de los posibles riesgos que puedan provocar los OGMs a la salud pública o al medio ambiente y a la diversidad biológica, podrán revisar los permisos otorgados y, en su caso, suspender sus efectos o revocar dichos permisos, cuando se presente un cambio en las circunstancias de las actividades que puede influir en el resultado del estudio de la evaluación de los posibles riesgos en el cual se basó el permiso, o cuando se cuente con información científica o técnica adicional que pudiese modificar cualesquiera condiciones, limitaciones o requisitos del permiso de liberación.
Adicionalmente la Ley de Bioseguridad tiene también la solicitud de reconsideración cuando la decisión ha sido desfavorable y el solitante pide a la autoridad recosiderarla.      
Es importante mencionar que para las preguntas 68 y 69, siempre, en todos los casos ha sido informado el notificador o promovente sobre la revisión y/o modificaciones tomadas de la decisión sobre algún permiso de liberación intencional al medio ambiente; sin embargo, hasta el momento estas comunicaciones no han sido reportadas al CIISB.
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • Yes
73. Has your country ever applied the simplified procedure?
  • Yes
74. If you answered Yes to question 73, has your country informed the Parties through the BCH of the cases where the simplified procedure applies?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • More than 5
76. Here you may provide further details on the implementation of Article 13 in your country:
ES
De acuerdo a la Ley de Bioseguridad de Organismos Genéticamente Modificados, a lo que se refiere a procedimiento simplificado, una vez que la autoridad competente ha otorgado una autorización para el uso y consumo humano, animal y para el procesamiento de OVMs, se puede proceder a la importación de los mismos sin requerimientos adicionales. Pero para el caso de la liberación intencional al ambiente de OVMs, no existe un procedimiento simplificado. Las respuestas afirmativas de la 72, 73 y 75, corresponden a las autorizaciones de AHAP otorgadas por la Secretaría de Salud.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • Yes
78. If you answered Yes to question 77, has your country informed the Parties through the BCH of the agreements or arrangements?
  • Yes, always
79. If you answered Yes to question 77, please provide a brief description of the scope and objective of the agreements or arrangements entered into:
ES
El 29 de octubre de 2003, la Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA), firmó un Arreglo Trilateral interinstitucional con Canadá y Estados Unidos de Norteamérica, denominado "Requisitos de Documentación para Organismos Vivos Modificados para Alimentación, Forraje o para Procesamiento OVM/AFP", que tiene como propósito articular un entendimiento entre los países signantes, respecto a los requisitos de documentación del Protocolo de Cartagena sobre Seguridad de la Biotecnología, respecto a los OVMs destinados al uso directo como alimento humano, forraje animal o procesamiento. El objetivo del Arreglo Trilateral es definir los requisitos de documentación para dar cumplimiento a los objetivos del Protocolo de Cartagena sin interferir innecesariamente en el comercio de la mercancía. Este documento contaba con dos años de vigencia, sin embargo el 31 de octubre de 2005, México junto con los otros dos países ya mencionados, firman una "Adenda" al Arreglo Trilateral, en el que se amplía la vigencia del mismo, por tiempo indefinido.
80. Here you may provide further details on the implementation of Article 14 in your country:
ES
Atendiendo a la implementación del Arreglo Trilateral y los requerimientos del PCB, el Gobierno Federal, a través de la Secretaría de Economía, Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación y la Secretaría de Hacienda y Crédito Público-Aduanas, y la Iniciativa Privada, a través del Consejo Nacional Agropecuario (CNA), la Asociación de Proveedores de Productos Agrocupecuarios de México A.C., la Confederación de Porcicultores Mexicana, la Asociación Nacional de Fabricantes de Alimentos Compuestos para Animales, la Unión Nacional de Avicultores, la Unión de Avicultores de Jalisco, la Asociación Mexicana de Productores de Alimentos, prepararon un esquema voluntario de cumplimiento de dicho Arreglo, a través del "Programa Piloto para la documentación que acompaña a las importaciones de maíz amarillo destinado para uso directo como consumo humano, animal o para procesamiento (Programa Piloto)" firmado en septiembre de 2005.
Este instrumento es de carácter voluntario; además se implementa en términos del Arreglo Trilateral; es compatible con las obligaciones que México ha asumido y con la legislación nacional; no implica la generación de nuevas disposiciones legales. Además es de fácil utilización, pues es a través de la factura comercial que acompaña a los cargamentos, en la que de incluye la leyenda: "Este embarque puede contener organismos vivos modificados para uso directo como alimento humano o animal o para su procesamiento y que no están destinados para su introducción intencional en el medio ambiente".
La Secretaría de Economía, como autoridad responsable de la implementación del Programa Piloto, documentó la experiencia a través del "Reporte de cumplimiento del Programa Piloto para la documentación que acompaña a las importaciones de maíz amarillo destinado para uso directo, consumo humano o animal, o para procesamiento", con sus Anexos; con lo anterior, México atendió la Decisión BS-III/10 de la COP-MOP 3, previo a la celebración de la COP-MOP 5, y aparece en el documento UNEP/CBD/BS/COP-MOP/5/INF/5.
Adicionalmente, al interior del país nos encontramos trabajando para poder seguir reportando con éxito.
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • No
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • Yes
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • Yes
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • In some cases only
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • More than 10
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • No
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • No
93. Here you may provide further details on the implementation of Article 15 in your country:
ES
De acuerdo a la legislación nacional el aplicante o promovente, en este caso el notificador, debe presentar en su solicitud de permiso de liberación al ambiente, un estudio de riesgo equivalente a una evaluación de riesgo. Las Autoridades Nacionales Competentes, con base en el estudio de riesgo y en otra información relevante, desarrollan una evaluación de riesgo de acuerdo a los principios de la evalución de riesgo que establece el Anexo III del Protocolo de Cartagena. Las evaluaciones de riesgo las llevan a cabo diferentes instancias involucradas que incluyen a la Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA) y la Secretaría de Medio Ambiente y Recursos Naturales (SEMARNAT) ésta última recibe e integra los insumos del Instituto Nacional de Ecología (INE) y de la Comisión Nacional para el Uso y Conocimiento de la Biodiversidad (CONABIO). La evaluación de riesgo es uno de los fundamentos para la toma de decisiones de los permisos de liberación al ambiente de OVMs, a la fecha se encuentra en desarrollo el marco normativo complementario a la Ley de Bioseguridad y su Reglamento.
El notificador de la solicitud en nuestro caso el promovente, debe pagar una cuota al presentar su solicitud de liberación misma que representa el derecho al trámite. Dicho pago no se canaliza directamente para costear la evaluación de riesgos que llevan a cabo las Autoridades Competentes. El promovente debería desarrollar y por lo tanto costear los estudios de riesgo que se presentan en la solicitud de liberación al ambiente y que analizan por las Autoridades Competentes a través de la evaluación de riesgo.
Con relación a la pregunta 84 es importante mencionar que la capacidad nacional no ha sido suficiente para la compleja situación del país. Tanto en número de personal como en capacidades técnicas. De cualquier forma se está haciendo un esfuerzo considerable para subsanar esta condición. Como indicador de esto se puede mencionar que el personal dedicado a actividades de bioseguridad pasó de 10 a 25. Así mismo las Autoridades Competentes se apoyan en grupos asesores con diversas capacidades técnicas.
Con relación a la pregunta 85, se aclara que no se tiene un mecanismo específico de capacitación de evaluadores, sin embargo cada instancia involucrada en la evaluación de riesgos ha desarrollado acciones específicas enfocadas al fortalecimiento de las capacidades individuales de sus evaluadores.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes, to some extent
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes, to some extent
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes, to some extent
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
ES
Se desarrollan simposiums, talleres, foros, tripticos y videos para comunicar a la comunidad científica y a poblaciones blanco usuarias de la tecnología, caso particular de los productores, acerca de la legislación y los procedimientos asociados a la importación, manipulación y siembra de cultivos genéticamente modificados con el objeto de la prevención de movimientos transfronterizos involuntarios.
A la comunidad científica se ha impartido talleres regionales para explicar la legislación así como sus obligaciones cuando llevan a cabo actividades de utilización confinada de OGMs.
Adicionalmente se ha trabajado con los reporteros que cubren la fuente sobre ciencia y biotecnología.
En casos de falta de certidumbre científica se pueden contemplar varias opciones de gestion de riesgos, entre estas se encuentran: solicitar información adicional, emitir la resolución condicionada al establecimiento de medidas de bioseguridad y encaminadas a prevenir, evitar y controlar posibles efectos adversos, así como establecer medidas de inspección, monitoreo y vigilancia y cuando así lo determine la Autoridad Competente, se requiere que se ejecuten protocolos de investigación para generar información que contribuya a reducir la incertidumbre.
La SEMARNAT dictamina negativo en caso de que sea permiso para SAGARPA y se resuelve negativamente en caso de que sea competencia de SEMARNAT.
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • Yes
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
107. Here you may provide further details on the implementation of Article 17 in your country:
ES
La Ley de Bioseguridad contempla que en caso de liberaciones accidentales de OVMs en el territorio nacional,  que pudieran tener efectos adversos significativos a la diversidad biológica o a la salud humana de otro país, la Autoridad Competente notificará tal situación a la autoridad correspondiente del país que pudiera resultar afectado por dicha liberación. Dicha notificación deberá incluir: I. Información sobre las cantidades estimadas y las características y/o rasgos importantes del OGM; II. Información sobre las circunstancias y la fecha estimada de la liberación accidental, así como el uso que tiene el OGM en el territorio nacional; III. Información disponible sobre los posibles efectos adversos para la diversidad biológica y la salud humana; IV. Información disponible sobre las posibles medidas de regulación, atención y control del riesgo, y V. Un punto de contacto para obtener información adicional. Además las Autoridades Competentes, realizarán las acciones y medidas necesarias para reducir al mínimo cualquier riesgo o efecto adverso que los OVMs liberados accidentalmente pudieran ocasionar.
Han ocurrido en nuestro país liberaciones accidentales de OVMs que han sido atendidas con las medidas adecuadas por las Autoridades Competentes. Por lo anterior se considera que no derivarían en un movimiento transfronterizo subsecuente por lo que no ha sido necesario informar a otros países Parte.
Las opciones de respuesta incluidas en la pregunta 103, no son aplicables a las situaciones que se han presentado en nuestro país,sin embargo, las Autoridades Competentes cuentan con la experiencia ganada en cada episodio enfrentado, se ha manejado coordinadamente entre las dependencias involucradas. y se considera que la atención que se presto a cada situación en particular, hace que no se tenga implicaciones transfronterizas a terceras partes.Uno de los casos más relevantes se reporto en enero del 2009 ante la Comisión para la Cooperación Ambiental, a la fecha el caso mencionada conserva el estado de concluido y cerrado, el documento in extenso se puede consultar en la siguiente liga:
http://www.cec.org/Page.asp?PageID=2001&ContentID=2411&SiteNodeID=547
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes, to some extent
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes, to some extent
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • No
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • Yes
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • Yes
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes, to some extent
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes, to some extent
115. Here you may provide further details on the implementation of Article 18 in your country:
ES
En el caso de movimientos transfronterizos de OVMs destinados a su liberación intencional al medio ambiente se establecen los requisitos de identificación para su importación en los respectivos permisos.
Para el caso de utilización confinada, se utiliza el instrumento de Aviso que se mencionó en el 6 (pregunta 28).
  En el caso de OVMs para uso directo como AHAP, se llevó a cabo un programa Piloto voluntario que tuvo un limitado alcance.  Mismo al que se hace referencia en la respuesta a la Pregunta 80.
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, more than one
119. In case your country designated more than one competent national authority, has your country conveyed to the Secretariat the respective responsibilities of those authorities?
  • Yes
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
121. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
123. Here you may provide further details on the implementation of Article 19 in your country:
ES
-
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information available and in the BCH
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information available but not in the BCH
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information available but not in the BCH
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available but not in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available but not in the BCH
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available but only partially available in the BCH
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available but only partially available in the BCH
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information not available
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information available but not in the BCH
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available but not in the BCH
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • No
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, in some cases
128. Has your country experienced difficulties accessing or using the BCH?
  • No
130. Is the information submitted by your country to the BCH complete and up-to date?
  • No
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • In some cases only
134. Here you may provide further details on the implementation of Article 21 in your country:
ES
onforme al artículo 71 de la Ley de Bioseguridad de Organismos Genéticamente Modificados, no tendrán el carácter de confidencial: I. La descripción general de los OVMs; II. La identificación del interesado o responsable de la actividad; III. La finalidad y el lugar o lugares de la actividad; IV. Los sistemas y las medidas de bioseguridad, monitoreo, control y emergencia, y V. Los estudios sobre los posibles riesgos a la salud humana o al medio ambiente y a la diversidad biológica.
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
136. If you answered Yes to question 135, how were these resources made available?
  • Bilateral channels
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Bilateral channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • Yes
140. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
141. If you answered Yes to question 140, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 150.
  • Difficult
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Pilot Biosafety Enabling Activity
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
  • Scientific biosafety research relating to LMOs
  • Actividades de fomento a la investigación científica en materia de bioseguridad y biotecnología
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • Yes
146. Does your country still have capacity-building needs?
  • Yes
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
148. Has your country developed a capacity-building strategy or action plan?
  • Yes
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
ES
En relación a la pregunta 142, es importante mencionar que el Fondo Global para el Medio Ambiente (Global Environmental Facility: GEF) y el Gobierno de México financiaron la segunda etapa del Proyecto Piloto "Fortalecimiento de la Capacidad Nacional para el Cumplimiento del Protocolo de Cartagena de 2006 a marzo de 2009, cuya gestión y administración se asignó al Programa de las Naciones Unidas para el Desarrollo (PNUD).
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes, to some extent
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes, to a limited extent
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes, to a limited extent
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes, to a limited extent
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes, to a limited extent
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • Yes
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • More than 5
160. Here you may provide further details on the implementation of Article 23 in your country:
ES
Se indica que la amplitud es limitada debido a que el mecanismo que se ha habilitado es a través de páginas de internet y existe un porcentaje importante de la población que no tiene aún acceso a estos sistemas de comunicación. Adicionalmente la manera como se presenta la información está dirigida, para su comprensión a un público con cierto nivel de educación académica.
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • Yes
162. Has your country ever imported LMOs from a non-Party?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • No
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • In some cases only
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • No
167. Here you may provide further details on the implementation of Article 24 in your country:
ES
Lo que corresponde a la importación de OVMs destinados a la liberación intencional en el medio ambiente, la Autoridad Competente, ha actuado conforme a las previsiones del Protocolo de Cartagena, sin embargo la implementación de las provisiones para el caso de los OVMs destinados a AHAP ha sido limitada. Adicionalmente existe un antecedente de una importación ilícita de OVMs que se liberaron ilegalmente al ambiente, mismo que no siguieron las provisiones del Protocolo: en este caso las Autoridades Competentes atendieron la liberación ilícita en consonancia con el Protocolo.
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Less than 5
171. Has your country informed the BCH and the other Party(ies) involved?
  • No
172. Has your country established the origin of the LMO(s)?
  • Yes
173. Has your country established the nature of the LMO(s)?
  • Yes
174. Has your country established the circumstances of the illegal transboundary movement(s)?
  • Yes
175. Here you may provide further details on the implementation of Article 25 in your country:
ES
Para más información se sugiere remitirse a pregunta 107.
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Only in some cases
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to a limited extent
178. Here you may provide further details on the implementation of Article 26 in your country:
ES
En relación a la cooperación proporcionada por México en cuanto al intercambio de información es relevante mencionar que durante los años 2008 y 2009 se participó en dos talleres que abordaban los asuntos clave tales como, reconocer el valor y uso de la biodiversidad, además de los aspectos económicos, sociales, culturales, reliogiosos, éticos e institucionales, para la aplicación del artículo 26 y en el que participaron expertos de diferentes partes del mundo. Estas actividades resultaron en la formulación de una guía metodológica para ser empleada en la evaluación de repercusiones socioeconomicas. En este momento, se participa en el foro en línea de impactos socioeconomicos y apoya la participación de expertos nacionales en este y otros foros internacionales.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • No
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
ES
En el seno de la Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados se ha acordado expresar la recomendación para que México firme el Protocolo de Nagoya-Kuala Lumpur de Responsabilidad y Compensación Suplementario al Protocolo de Cartagena, y que la Comisión asumirá la responsabilidad por el pago correspondiente a los costos por concepto de los servicios que ofrecerá el Secretariado del Protocolo de Nagoya-Kuala Lumpur de Responsabilidad y Compensación Suplementario al Protocolo de Cartagena.
La Secretaría de Relaciones Exteriores, en atención al acuerdo de la CIBIOGEM está trabajando en los procedimientos encaminados a la firma.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.
ES
Se han identificado algunas dificultades técnicas para el llenado del formato de informe en línea. Estas se refieren a algunas preguntas para las que se consideró conveniente seleccionar más de una respuesta, pero que el formato en línea no permite esta posibilidad. Como ejemplos se mencionan: la pregunta 46 en la que la respuesta seleccionada por nuestro país sería "Si, siempre" al notificador y "Solo en algunos casos al CIIBS". Pero en el formato se dejó únicamente la primera opción de respuesta. Esta es la misma situación para la pregunta 62, en la que se seleccionaron dos opciones de respuesta ("Solo en algunos casos" y "Si pero con demoras") y de las preguntas 68, 69 y 70 en las que la respuesta es que siempre se ha informado al notificador pero no se ha notificado al CIIBS.
En el caso de la pregunta 48, se debía ingresar los porcentajes con cifras en decimales, esto es 91.5% de decisiones que incluyen aprobación con condiciones y 8.5% de decisiones que incluyen prohibir la importación. Sin embargo el formato no acepta cifras con datos decimales. Se optó por cerrar las cifras a 91% y 9% respectivamente.

En la pregunta 103, como se detalla en la respuesta a la pregunta 107, se considera que ninguna de las respuestas refleja la condición de nuestro país, y se había optado por dejar esa respuesta vacía. El formato en línea considera esa pregunta como campo de respuesta obligatoria y dado que no se podría enviar el formato sin las respuestas completas, se optó incluir la opción de nunca.
Survey on indicators of the Strategic Plan (2014)
In decision BS-VI/15, Parties requested the Executive Secretary to conduct a dedicated survey to gather information corresponding to indicators in the Strategic Plan that could not be obtained from the second national reports or through other existing mechanisms.

The answers to the survey are displayed below.
When did your national biosafety framework become operational?
indicator 1.1.1
  • 2001 or earlier
Here you may provide further details
ES
The National Council for Science and Technology (CONACYT) implemented a program in 2012 for the improvement of confinement infrastructure in laboratories and research facilities working with GMO the total investment reached $621,263.86usd. With the CIBIOGEM Found we are financing the execution of 8 research projects with three main approaches: to generate baseline information to inform conservation programs (1), development of biotechnology applications to target National needs (3) and research on biosafety issues to inform decision makers (4), the resources invested for these research projects reaches about $1,606,008.11usd. We worked at the establishment and development of the Laboratories National Network for Detection, Identification and Quantification of OGM (RNLD-OGM) and we have invested close to $65,640.36usd, mainly for collaborative studies and development of reference samples. We founded the Mexican Network of GMO's monitoring, with an initial investment of $36,126.56usd. Finally we have regularly performed the contributions to the Cartagena's Protocol by 4 years with around of $321,133.00usd.  Additionally, the National Commission for the Knowledge and Use of Biodiversity (CONABIO)  between 2009 - 2012, financed with around of $1.662.532,18 USD a total of 15 projects to obtain baseline information related to genetic diversity of species and their wild relatives as well as for some of them the distribution information to determine some of their centers of origin and diversity.
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 1 per year or more
Here you may provide further details
ES
Short-term training organized by government.  Undergraduate and graduate academic courses: Universidad Nacional Autónoma de México (Biosafety), Tecnológico de Monterrey (Biosafety and Ethics), Universidad de Nuevo León.
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • Yes
Here you may provide further details
ES
Every two years a Biannual Program of Work (PTB) is agreed by the CIBIOGEM, this includes Biosafety Capacity Building activities.
Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
indicator 1.2.5
  • 1,000,000 USD or more
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • Yes
Here you may provide further details
ES
There is a provision under the Biosafety Law, in articles 28 and 31, which calls for the creation of a Fund that collects resources to be invested in human capacity building, infrastructure for public institutions, research projects and other activities related to the safe use of Modern Biotechnology. This CIBIOGEM Fund is operational since 2009. Additionally each Competent Authority has a budgetary allocation for Capacity Building to take care of each sector (Envrionment, Healht and Agriculture) requirements.
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • One or more
Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?
indicator 1.3.1.1
Survey 9.a) Risk assessment
  • Yes
Survey 9.b) Risk management
  • Yes
Here you may provide further details
ES
Initially, guidance documents used were those developed by OECD and Annex III of the Cartagena Protocol, these are complemented now  by guidance documents and protocols to carry out risk assessment and risks management activities. The refered guidance documents have been developed by the different National Authorities for dealing with different issues under their responsibility. For example, they have developed information systems to inform decisions making such as: Aromma by INECC (http://www2.inecc.gob.mx/aromma/), check list by CONABIO, ARIMIL by SAGARPA. Besides, monitoring and inspection guidelines have been developed by the authorities, to verify compliance with permit provisions. There are also protocols developed for coordinated management responses, these were produced in a coordinated effort by CIBIOGEM.   The Ministry of Health, through the Federal Commission for Protection against Health Risks (COFEPRIS) carries out risk assessments using the guidelines authorized and published by the Health Sanitary Authority named the "Procedure for the Safety Assessment of Genetically Modified Organisms, intended for use or Human Consumption, Food processing, Bioremediation and Public Health" which can be found at: http://www.cofepris.gob.mx/AZ/Paginas/OGMS/OGMS.aspx
Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?
indicator 1.3.1.2
  • No
Here you may provide further details
ES
Until today, Mexico has not used any guidance for the purpose of evaluating risks assessments reports submitted by notifiers once an environmental release of a GMO has been accomplished, under an issued permit. However a Mexican Official Standard (NOM) is being developed concerning the information that the notifier must submit to the authorities as a report of an authorized experimental environmental release.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • No
Here you may provide further details
ES
There are some common approaches to risk assessment, particularly in the context of the North American Plant Protection Organization (NAPPO), with the main focus on risk assessment for plant pests that could be implemented for GM plants, however this approaches are not adopted as binding. According to the provisions of the Law on Biosafety of GMOs, there are precise periods for the Authorities to resolve different types of applications, these provisions complicate synchronic evaluations. For example, Article 95, states that  the resolution for authorizations shall be issued by the Secretary of Health, within a period not exceeding six months after the reception of a complete application (that includes studies of possible risks that the human use or consumption of the GMO could have as well as scientific and technical information concerning its safety). These conditions differ in each country based on its regulation; so although Mexico follows international guidelines of, for example the Codex Alimentarius, in the case of safety assessment of GMOs for direct use as food, feed or processing; we have not adopted common approaches to risk assessment with other countries.
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
Here you may provide further details
ES
Since 1995 up to September 2013, the Secretary of Health has evaluated and granted 116 authorizations for GMOs to be use direcctly as food, feed and procesing, of which 55 are of Zea mays. These "Authorizations for marketing and import of GMOs" were issue according to the provisions of the Law on Biosafety of Genetically Modified Organisms and Regulations under the General Healht Law.  In relation to the environmental release of GMOs in Mexico, since 1988 to September 2013, the Secretary of Agriculture has received 888 applications. These applications include the three types of release (experimental, pilot phase and lately commercial release), usually corresponding with specific GMO events, considering in many cases different potential receiving environments, hence the number of risks assessment evaluations under the case by case approach, up today are over 3000.     For example, just during the last four years (2009-2012), CONABIO has issued 415 opinions to the Competent Authority on applications for environmental release of GMO.
Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
indicator 1.4.2
Survey 13.a) Identify
  • Yes
Survey 13.b) Assess
  • Yes
Survey 13.c) Monitor
  • Yes
Here you may provide further details
ES
There are three qualified laboratories one in each of the Secretaries (Agriculture, Health and Environment) that are National Competent Authorities under the Cartagena Protocol. Additionally, in the national laboratory network, 10 independent and properly assessed laboratories in national academic institutions have GMO detection, identification and quantification capacities. Qualified groups for risk assessment and risk management exist also within the different competent authorities, and a Monitoring Network is in process to be implemented and operational, for contributing to the monitoring activities of the Authorities.
Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
indicator 1.6.4
  • No
Here you may provide further details
ES
A Mexican Offical Standard (NOM) is in consideration to be develop.
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • Yes
Here you may provide further details
ES
The Biosafety Law envisages in article 64, that socioeconomic aspects may be considered additionally to the risk assessment, in the decision making procedure for the environmental release of GMOs.
Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
indicator 1.7.1
  • One or more
Survey 17. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making?
indicator 1.7.3
ES
Socio-economic considerations have been taken into account to establish policies for the environmental release of GM maize.
Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
indicator 1.8.3
  • Yes
Here you may provide further details
ES
Mexico has faced cases of unintentional planting of GM maize grains authorized for FFP that entered the country as commodities. Since some of the traditional practices of small farmers include to experiment with new seeds, around 2001, small farmers presumably planted grains from commodities that included GM material that was not intended for environmental release. There have also been cases of accidental releases during transport of GM maize approved for FFP. Also there have been cases of illegal planting of GM maize. All these situations have been dealt with and appropriate measures have been taken.
Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
indicator 2.2.3
Survey 19.a) Risk assessment
  • 100 or more
Survey 19.b) Monitoring
  • 50 or more
Survey 19.c) Management / Control
  • 50 or more
Here you may provide further details
ES
There are periodic capacity building courses organized by the government, as well as possibilities for government officials to attend different international training programs. Different officials working with Competent Authorities take these opportunities and share their experiences with colleagues. New officials are trained by experienced ones as part of their jobs and duties.
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
Here you may provide further details
ES
There are three qualified laboratories one in each of the Secretaries (Agriculture, Health and Environment) that are National Competent Authorities under the Cartagena Protocol. Additionally, in the national laboratory network, 10 independent and properly assessed laboratories in national academic institutions have GMO detection, identification and quantification capacities. Qualified groups for risk assessment and risk management exist also within the different competent authorities, and a Monitoring Network is in process to be implemented and operational, for contributing to the monitoring activities of the Authorities. The analytical techniques implemented in these labs include: Final Point PCR, Real Time Digital PCR and High throughput DNA Sequencing.
Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
indicator 2.2.5
  • Yes
Here you may provide further details
ES
The different institutions have done efforts to develop training materials such as videos, brochures and guidance documents, for instance. However, the developments in this area are still limited.
Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?
indicator 2.2.6
Survey 22.a) Sufficient
  • No
Survey 22.b) Effective
  • No
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • One or more
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 50 or more
Here you may provide further details
ES
There have been several training courses in sampling and detection of LMOs, in Mexico. Different personnel have taken the courses but also the same group of people has received different training material for laboratory techniques, related to GMO detection, identification and quantification. In Mexico we are working with the National Laboratories Network for Detection, Identification and Quantification of GMO (RNLD-OGM), each of the laboratories participating has been involved in a training process and in collaborative studies.
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Here you may provide further details
ES
See prevous comments
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Here you may provide further details
ES
Two of the government Laboratories for GMO detection, are certified. Sixteen interested laboratories have participated in collaborative studies coordinated by CIBIOGEM and the National Center for Metrology (CENAM) and twelve of these have quality control measures, and showed expected and consistent results. These laboratories are in public institutions and not all are interested in getting a certification, but only to have recognition of their methodologies.
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
Here you may provide further details
ES
We have 12 operational laboratories, two of them certified.
Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
indicator 2.4.1
  • No
Here you may provide further details
ES
No, during the past 4 years.
Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
indicator 2.4.2
  • Yes
Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
indicator 2.5.2
  • Yes
Here you may provide further details
ES
According to the Biosafety Law, all applications for environmental release go through a public consultation process. The competent authorities distribute and give publicity to the applications for environment release of GMOs. Also, CIBIOGEM provides information in its WEB site, through social networks and a mail distribution lists.
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • National website
  • Mailing lists
  • Social networks
Survey 32. If you indicated multiple modalities for public participation in the question above, which one was most used?
indicator 2.5.2
  • National website
Here you may provide further details
ES
The applications for environmental release are available for public comments in the national websites. The periods for receiving comments are limited. Website such as SAGARPA, social networking (Facebook, Twitter, Lindked, Scoopit) and mail distribution lists to interests stakeholders.
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • 5 or more
Here you may provide further details
ES
There are some courses at different education institutes, at undergraduate and graduate level. One of the most important is the Autonomous National University of Mexico (UNAM).
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • One or more
Here you may provide further details
ES
The Secretary of Health, through the Health Promotion Commission, published on its website, the "List of Safety assessment case by case of GMOs" where you can check GMOs authorized by this Authority, company of the applicant, the name and characterization of the event, the recipient organism, donor organisms and genes used. Also, you can find information on the safety assessment of crops and phenotypes used for different GMOs, which can be found at: http://www.cofepris.gob.mx/AZ/Paginas/OGMS/OGMS.aspx
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • Yes
Survey 35.b) Enforcement system
  • Yes
Here you may provide further details
ES
Mexico has an enforcement system related to compliance of the Biosafety Law. The question about monitoring is not very clear in relation to what is there to monitor beside the monitoring activities related to GMOs in the environment. However we report every year the state of the art of activities related to Biosafety of GMOs. The annual report s available at the CIBIOGEM Webpage Mexico has also complied with all the reports mandated under the Cartagena Protocol provisions.
Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.
indicator 4.3.1
  • 25 or more
Here you may provide further details
ES
The CIBIOGEM in its Biannual Programs of Work included society participation and exchange of biosafety information with all stakeholders as a very relevant activity, thus multiple events have been conducted with researchers, government officials, journalists, students at different levels (university, secondary, elementary), teachers, farmers and civil associations, among others. In addition CIBIOGEM has participated, explaining issues on the safe use of biotechnology and the regulation of GMOs, in workshops, science festivals, seminars, conferences organized by associations, universities and institutes.
Survey 37. Please indicate the number of biosafety related publications that has been made available in your country in the last year.
indicator 4.3.2
  • One or more
Here you may provide further details
ES
"Manual y protocolos para la cuantificación de organismos genéticamente modificados" 2013, this document was published this year by the Secretary of Economy, CENAM, CONACYT and SAGARPA.   Ederson Akio Kido, Elizabeth Hodson de Jaramillo, Fernando Carlos Zelaschi, Francisco José Lima Aragao, Gutenberg Delfino de Sousa, Isabel Saad Villegas, José Luis Solleiro Rebolledo, Josias Correa de la Faria, Marcia Almeida de Melo, María Mercedes Roca, Moisés Burachik, Paulo Paes Andrade, Sol  Ortiz Garcia & Wayne Parrot. 2012. Guía para la Evaluación de Riesgo Ambiental de Organismos Genéticamente Modificados. 140 pp International Life Science Institute. Brasil. ISBN 978-85-86126-41-3.
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • Sending the publication to relevant stakeholders. Besides that they are available at the NAtional web site.
Survey 39. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
indicator 5.2.1
  • One or more
Here you may provide further details
ES
Mexico in the past four years has been active in regional initiatives and international collaboration, has hosted meetings of the Secretariat for issues such as liability and redress and risk assessment. Also, we have held meetings in their outreach program that included the participation of the Secretariat.
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
Here you may provide further details
ES
Under the Program for the Development of Biosafety and Biotechnology, we are implementing  a National Pilot Program on Education in Biotechnology (Elementary Level), each year we offer the "Open House Day" of the Executive Secretariat CIBIOGEM (for General Public), Week of Science and Technology Fair: experimental Workshops "hands on", presentations to all levels of education, National Workshops on Biotechnology and Biosafety of GMOs for journalists, Interministerial Workshop of researchers and developments on biotechnology and GMO'S biosafety sponsored by the Federal Government, National Meetings of the National Network on GMOs monitoring and National Meetings of the National Network of GMOs detection laboratories.
Survey 41. If you answered yes to the question above, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place.
indicator 5.3.1
E.g. local, national, etc.,
ES
CIBIOGEM has a Working Group on Communication integrated by the different communication areas and the Executive Secretariat of the Commission has a unit in charge of this issue too.  The scope of these areas is national and regional (witihn Mexico) considering the program or the activities that are taking place.
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • Yes
Here you may provide further details
ES
Yes. We have designed some communication strategies toward to different target groups and these have being partially implemented; however we recognize their limited scope.
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • 5 or more
Here you may provide further details
ES
The materials developed or that we have available so far include handbooks (ABC of GMOs), brochures, books, manuals, videos, games and specific sections for target groups on the website, among others.