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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109641
Status
Published
Date of creation
2016-01-28 17:22 UTC (elisa.dalgalarrondo@mvotma.gub.uy)
Date of publication
2016-01-28 17:22 UTC (elisa.dalgalarrondo@mvotma.gub.uy)

This document is also available in the following languages:
Origin of report
1. Country
  • Uruguay
Contact officer for report
Coordinates
Ingeniera Agrónoma Elisa Dalgalarrondo
Punto Focal Nacional CIISB/BCH. Dirección Nacional de Medio Ambiente (DINAMA).
Dirección Nacional de Medio Ambiente - Ministerio de Vivienda, Ordenamiento Territorial y Medio Ambiente (DINAMA - MVOTMA)
Galicia 1133
Montevideo, Montevideo
Uruguay, 11100
Phone:+598 29170710 ext. 4454/4456
Fax:+598 29170710 ext. 4410
Email:elisa.dalgalarrondo@mvotma.gub.uy
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
ES
Ministerio de Relaciones Exteriores (MRREE); Ministerio de Salud Pública (MSP); Ministerio de Economía y Finanzas (MEF); Ministerio de Vivienda, Ordenamiento Territorial y Medio Ambiente (MVOTMA); Instituto Nacional de Semillas (INASE); Comisión para la Gestión del Riesgo (CGR); Evaluación del Riesgo en Bioseguridad (ERB)
Submission
10. Date of submission
2016-01-28
11. Time period covered by this report
Start date
2012-01-31
11. Time period covered by this report
End date
2015-11-30
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is partially in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2001 or earlier
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety regulations
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes, to some extent
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
Antecedentes: Comisión Asesora de Análisis de Riesgo en la Dirección General de Servicios Agrícolas del MGAP para analizar autorización soja 40-3-2 (año 1996); Comisión de Evaluación de Riesgo de Vegetales Genéticamente Modificados (CERV), creada por  Decreto 249/2000 como organismo asesor del poder Ejecutivo, para analizar autorización maíces MON810 (año 2003) y BT11 (año 2004). 
El Decreto 353/008 (y textos modificativos Decs.535/008 y 280/009) es la norma vigente actualmente en materia de bioseguridad de vegetales genéticamente modificados a través de la cual se materializa la salida de la etapa de moratoria establecida previamente (Decreto 037/007), definiéndose la actual estructura institucional para vegetales y sus partes genéticamente modificados (VGMs). Para proceder a su autorización, establece que la introducción, uso y manipulación de VGMs, cualquiera sea la forma o el régimen bajo la cual se realicen, sólo podrán efectuarse previa autorización, concedida caso a caso, por las autoridades competentes, teniendo en cuenta los resultados de las correspondientes etapas de la evaluación y gestión del riesgo de esa aplicación sobre el ambiente, la diversidad biológica, la salud humana, la sanidad animal y vegetal y aspectos socioeconómicos.  Se establece además el interés hacia la promoción de una política de coexistencia regulada entre VGMs y no modificados. Estructura institucional creada por Decreto 353/008:
- Gabinete Nacional de Bioseguridad (GNBio), integrado por los Ministros de Ganadería, Agricultura y Pesca (ejerce la presidencia); Salud Pública; Economía y Finanzas; Vivienda, Ordenamiento Territorial y Medio Ambiente; Relaciones Exteriores; Industria, Energía y Minería. El GNBio autoriza, previo trámite correspondiente, las solicitudes de VGMs que ingresan al país; define lineamientos de la política nacional de bioseguridad de VGMs.
- Comisión para la Gestión del Riesgo (CGR); integrada por un delegado de cada uno de los Ministerios del GNBio. Lleva a cabo las actividades para la ejecución del sistema; entre otras funciones, elabora los Términos de Referencia que orientan la Evaluación de Riesgo de cada caso analizado, así como la formalización de la comunicación pública.
- Evaluación del Riesgo en Bioseguridad (ERB); es la instancia técnico-científica de la Evaluación de Riesgo. Entre sus funciones, está la de asegurar el análisis caso a caso de la  Evaluación de Riesgo sobre bases científicas objetivas, promoviendo el trabajo en red entre evaluadores. Para llevarlo a cabo, se vincula con el Comité de Articulación Institucional. 
- Comité de Articulación Institucional (CAI); es la instancia auxiliar básica del proceso de Evaluación de Riesgo integrada por delegados de diferentes organismos públicos, de investigación y la Academia, quienes elaboran las evaluaciones de riesgo respectivas.
Además, la Ley Nº 17.283 de Protección del Medio Ambiente (año 2000), establece en materia de bioseguridad (art.23) que el Ministerio de Vivienda, Ordenamiento Territorial y Medio Ambiente dicte las providencias y aplique  las medidas necesarias  para prevenir y controlar los riesgos ambientales derivados de la creación, manipulación, utilización o liberación de OGMs en cuanto pudieran afectar la conservación y utilización sostenible de la diversidad biológica y el ambiente.
Se está trabajando actualmente en la elaboración de un proyecto de Ley Nacional de Bioseguridad para todos los organismos genéticamente modificados a ser enviado al Parlamento Nacional.    



    

Article 5 - Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • No
24. Here you may provide further details on the implementation of Article 5 in your country:
ES
El 13 de febrero de 2015 entra en vigencia el Decreto 38/015 que aprueba las pautas para el Registro de Medicamentos Biotecnológicos y para las vacunas que incluyan componentes producidos por técnicas de ADN recombinante.   El Decreto 38/015 define Medicamentos Biotecnológicos como aquellos que contienen principio/s activo/s obtenido/s a partir de cultivo celular, microorganismos o células vivas por la tecnología del ADN recombinante o técnicas de hibridomas.                                                       
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • Yes
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Partially
28. Here you may provide further details on the implementation of Article 6 in your country:
ES
La liberación bajo uso contenido es una de las aplicaciones contempladas en el  art.3 del Decreto 353/008, refiriéndose a la liberación  a escala de laboratorio y de invernáculo.  La liberación bajo uso contenido, se encuentra sujeta al estricto cumplimiento de un Protocolo de Bioseguridad específico establecido por la CGR, además de la creación de una comisión interna de bioseguridad por parte de cada institución que desarrolla y/o manipula VGM, la cual debe presentar anualmente un informe acerca del desarrollo de los ensayos.
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 OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. 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?
  • No
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • Yes
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • Yes
36. If you answered Yes to question 35, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • More than 10
37. If you answered Yes to question 35, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • None
38. 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
39. 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
40. 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
41. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes
42. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Yes
43. Has your country informed the notifier(s) and the BCH of its decision(s)?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
44. What percentage of your country’s decisions fall into the following categories?
  • Approval of the import/use of the LMO(s) with conditions
50%
  • Approval of the import/use of the LMO(s) without conditions
50%
45. 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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
46. 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 nuestro país el procedimiento para el Análisis de Rriesgo se inicia con la Solicitud de Autorización para la Introducción, Uso y Manipulación de VGMs. Dicha Solicitud ingresa a la Oficina de Bioseguridad del MGAP, realizándose la publicación de la misma. La CGR elabora los Términos de Referencia para que se desarrolle la Evaluación de Riesgo estipulando asimismo los plazos para las distintas instancias del proceso. Un resumen de la Solicitud se publica para la ciudadanía (sitio web MGAP). La ERB coordina la Evaluación de Riesgo, comenzando así la etapa técnico-científica del análisis, articulando con el CAI. Las instituciones que conforman el CAI elaboran sus informes, así como los diferentes grupos ad hoc conformados para temas específicos: Organismos No Blanco; Caracterización Molecular; Flujo Génico y Coexistencia; Salud Humana y Animal. Posteriormente la ERB recopila estos informes,  elabora el propio y lo eleva a la CGR. Paralelamente MGAP realiza un informe socioeconómico (para las solicitudes de liberación comercial) y se formaliza la consulta pública (durante 1 mes se reciben comentarios de la comunidad acerca de la solicitud y permanecen publicados los informes elaborados por el CAI). La CGR elabora su informe de recomendación acerca de la solicitud de liberación y lo eleva al GNBio. Finalmente, y luego de realizado  el análisis técnico-científico, el GNBio toma la decisión final acerca de la solicitud.  La CGR informa acerca de la decisión final al solicitante y a la ciudadanía.
La introducción deliberada en el medio ambiente incluye aplicaciones referidas a producción de semilla para exportación, así como uso comercial para consumo directo y procesamiento, publicándose 15 resoluciones correspondientes al período 2012-2015. Para las aplicaciones para Investigación y Evaluación Nacional de Cultivares corresponden 12 resoluciones GNBio para el período 2012-2015. 
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. 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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
53. How many LMOs-FFP has your country approved to date?
  • More than 10
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
55. 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
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
57. 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?
  • Yes, but with delays (i.e. longer than 15 days)
58. 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
Las decisiones de liberación para uso comercial, consumo o procesamiento de VGMs, hasta el momento  han sido elaboradas  conjuntamente.                                                   
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes, to some extent
60. Has your country ever received a request for a review of a decision?
  • No
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
66. Here you may provide further details on the implementation of Article 12 in your country
ES
En las decisiones finales del GNBio, se establece que el solicitante deberá comprometerse a informar a las autoridades competentes (a través de la CGR) sobre cualquier cambio en la información presentada que afecte las conclusiones del expediente analizado, reservándose éstas el derecho a disponer la realización de un nuevo análisis de riesgo y proceder a la revisión de la decisión adoptada si fuera necesario. El solicitante deberá presentar a la CGR una declaración en la que se compromete a recuperar del mercado todo producto derivado directamente del evento si así lo requiriera la autoridad competente.     
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
68. Has your country ever applied the simplified procedure?
  • No
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
  • Yes
79. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
This question is relevant to indicator 2.2.3 of the Strategic Plan
a) Risk assessment:
  • 100 or more
b) Management / Control:
  • 10 or more
c) Monitoring:
  • One or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • Yes
84. Does your country have the capacity to detect, 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?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • No
88. 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?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • No
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Commercial production
  • Field trial
  • LMOs for Contained use
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?
  • Yes, always
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
  • More than 10
94. 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, to some extent
Here you may provide further details
ES
Durante la Evaluación Nacional de Cultivares (período de 2 años), sólo se realiza la evalución agronómica del cultivar.
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • No
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
This question is relevant to indicator 2.2.4 of the Strategic Plan
  • Yes
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
ES
Entre los cometidos de la ERB definidos en el Decreto 353/008, se incluye la identificación de las capacidades nacionales y/o regionales disponibles para el análisis multidisciplinario que implica la Evaluación de Riesgo, asegurando de esta  manera que las evaluaciones van a ser llevadas a cabo por los técnicos más capacitados del país.
Todos los VGMs que son liberados al ambiente pasan por una Evaluación Agronómica de Culivares, etapa llevada a cabo por el Instituto Nacional de Semillas (INASE), durante la cual se realiza el estudio agronómico de los cultivares. Si bien al día de hoy, durante esta evaluación no se observan características del transgen, ni su comportamiento/impacto en el ambiente, estas evaluaciones podrían a futuro servir a este fin, si se coordinan las vías correspondientes.
Existen varios laboratorios tanto públicos como privados con la capacidad de poder detectar e identificar OGMs tanto en materiales crudos como en matrices complejas, pero no existe un laboratorio nacional de referencia que se dedique al tema, ni tampoco existe actualmente una red de detección conformada por los laboratorios existentes. El laboratorio de técnicas moleculares de INASE realiza detección e identificación de toda la semilla importada para verificar que tengan únicamente eventos autorizados. El laboratorio de bromatología de la Intendencia de Montevideo realiza detección e identificación de alimentos.
El art. 8 del Decreto 353/008 establece el marco legal para realizar fiscalización, asignándole competencia en materia inspectiva en relación al cumplimiento del Decreto a cuerpos inspectivos del GNBio.  Específicamente en cuanto al control del cumplimiento de  protocolos de bioseguridad para ensayos de investigación, evaluación agronómica y producción de semilla para exportación, se realiza con apoyo de INASE que coordina acciones con la Dirección de Recursos Renovables (RENARE) del MGAP.
Respecto a procedimientos de vigilancia, al día de hoy no se han implementado protocolos de  monitoreo, ni una infraestructura específica para poder fiscalizar los eventos ya liberados al ambiente.
En referencia a la pregunta 85, vinculada a documentos de orientación utilizados para realizar las evaluaciones, en nuestro país no hay un documento único que se tome en cuenta. La CGR es quien fija los términos de referencia para los análisis a realizar. Los técnicos e instituciones tienen la potestad para poder utilizar las guías que entiendan pertinentes; de hecho, algunas instituciones que conforman el Sistema Nacional de Bioseguridad han utilizado el Manual y la Guía elaborados por la CDB, sin embargo no hay definición a nivel país para la adopción de ninguna guía específica.     
Article 17 – Unintentional transboundary movements and emergency measures
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes, to some extent
99. 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?
  • No
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. 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
105. Here you may provide further details on the implementation of Article 17 in your country
ES
Existen Protocolos de Bioseguridad específicos para liberaciones bajo condiciones controladas (multiplicación semillas para exportación, Investigación, Evaluación Nacional de Cultivares, Laboratorio e Invernáculo), en los cuales se establecen medidas para prevenir liberaciones involuntarias. Se requiere mayor capacitación para ajustar  procedimientos específicos para el control aduanero.  En referencia a las preguntas 98, 99 y 100 consideramos que la respuesta es diferente de acuerdo a cómo se interprete "mov. transfronterizo involuntario". Existen protocolos de bioseguridad para prevenir escapes involuntarios para eventos aprobados para uso controlado (ej multiplicación semilla, experimentación), no así cuando se trata de escapes de eventos no autorizados.
                                               
Article 18 – Handling, transport, packaging and identification
106. 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
107. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes, to some extent
108. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes, to some extent
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing or a stand-alone document
110. 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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing types of documentation
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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes, to some extent
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing types of documentation
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • Yes
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • None
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 50 or more
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
This question is relevant to indicator 2.3.2 of the Strategic Plan
  • Yes
120. How many laboratories in your country are certified for LMO detection?
This question is relevant to indicator 2.3.3 of the Strategic Plan
  • None
122. Here you may provide further details on the implementation of Article 18 in your country:
ES
Existen en el país  laboratorios en diferentes instituciones con capacidad para detección e identificación de VGMs, como los de la Universidad de la República, Intendencia de Montevideo, Intituto Nacional de Semillas, Laboratorio Tecnológico del Uruguay.
Article 19 – Competent National Authorities and National Focal Points
123. 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
124. 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, to some extent
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
126. Please provide an overview of the status of the mandatory 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.
This question is relevant to indicator 3.1.5 of the Strategic Plan
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
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
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
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
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information not available
f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
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 and in the BCH
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
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 and in the BCH
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 and in the BCH
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 available but only partially available in the BCH
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
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
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 and in the BCH
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes, to some extent
128. 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, to some extent
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, in some cases
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • No
131. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
132. 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:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • 10 or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • One or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National Libraries
  • Tesis de Licenciatura y Maestría vinculadas a la temática
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. Here you may provide further details on the implementation of Article 21 in your country
ES
El marco legal que regula la información confidencial es la Ley de acceso a la Información Pública (Ley Nº18381)
Article 22 – Capacity-building
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • No
140. 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
141. If you answered Yes to question 140, how were these resources made available?
  • Bilateral channels
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
145. If you answered Yes to question 144, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 157.
  • Average
146. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Development of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
147. 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
148. If you answered Yes to question 147, 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
  • Taking into account risks to human health
  • Implicancias OVM sobre Organismos No Blanco, Comunicación interna miembros Sistema Nacional de Bioseguridad
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • Yes
150. If you answered Yes to question 149, has this information been submitted to the BCH?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • Yes
152. If you answered Yes to question 151, 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
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
  • Manejo de la Coexistencia entre diferentes sistemas de producción; Tecnologías asociadas al uso de OVMs; Evaluación de riesgo y nuevas tecnologías;
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • Yes
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • No
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • 1 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
Article 23 – Public awareness and participation
158. 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
Here you may provide further details
ES
En el Decreto 353/008 están previstos los mecanismos para la participación pública dentro del proceso de análisis de riesgo (arts. 5 y 6) .
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • Yes
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • No
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
ES
En referencia a la pregunta 159, Uruguay acaba de finalizar la elaboración del plan estratégico de comunicación (año 2015).                                                                                      ]
162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?
This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan
  • Yes
163. 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?
This question is relevant to indicator 5.2.1 of the Strategic Plan
  • One or more
164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes, to some extent
Here you may provide further details
ES
En la sitio web del MGAP se encuentra disponible información sobre  eventos aprobados, normativa y resoluciones GNBio. Se continúa trabajando para lograr mayor accesibilidad de la ciudadanía a la información
165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Yes
168. If you answered Yes to question 167, please indicate the modalities used to inform the public:
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
  • Newspaper
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
171. How many academic institutions in your country are offering biosafety education and training courses and programmes?
This question is relevant to indicator 2.7.1 of the Strategic Plan
  • 3 or more
172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:
This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan
  • None
173. 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 some extent
Here you may provide further details
ES
Talleres en el marco del Proyecto MGAP/FAO y de Bioseguridad de GENOK
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • No
175. 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
Article 24 – Non-Parties
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • Yes
179. Has your country ever exported LMOs to a non-Party?
  • Yes
180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes
181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?
  • No
Article 25 – Illegal transboundary movements
184. 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
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes, to some extent
Here you may provide further details
ES
El mecanismo existente se activa por parte de la CGR como respuesta a denuncias de movimientos transfronterizos ilícitos de OVMs.
186. 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?
If you replied Never to question 186 please go to question 191
  • Never
191. Here you may provide further details on the implementation of Article 25 in your country
ES
Si bien durante el período considerado se recibió información acerca de posibles movimientos transfronterizos ilícitos, se constató que no se trataba de movimientos transfronterizos ilícitos 
Article 26 – Socio-economic considerations
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • Yes
193. 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?
  • Yes
194. 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?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • None
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
ES
Para el caso de solicitudes de liberación comercial, se elabora  un informe socioeconómico y de mercado complementario a la Evaluación de Riesgo,  el cual es elaborado por la Oficina de Programación y Política Agropecuaria (OPYPA;  MGAP), este informe  se eleva a consideración del GNBio para el caso de solicitudes de liberación comercial.                                                                                                    
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • No
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
199. If you answered No to question 198, is there any national process in place towards becoming a Party?
  • No
200. 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?
This question is relevant to indicator 2.4.1 of the Strategic Plan
  • No
201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan
  • Yes
Article 28 – Financial Mechanism and Resources
203. 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?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • Not applicable
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • No
b) Enforcement system:
  • No
205. Has your country submitted all the previous due National Reports?
  • No
206. If you answered No to question 205, indicate the main challenges that hindered the submission:
  • No obligation to submit (e.g. country was not a Party at the time)