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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102166
Status
Published
Date of creation
2011-08-17 15:28 UTC (bch@humboldt.org.co)
Date of publication
2011-08-17 15:28 UTC (bch@humboldt.org.co)

This document is also available in the following languages:
Origin of report
Country
  • Colombia
Contact officer for report
Coordinates
Señora María José Calderón
Bióloga, contratista Dirección de Ecosistemas
Ministerio de Ambiente, Vivienda y Desarrollo Territorial (MAVDT)
Calle 37 No. 8-40
Bogotá D.C.
Colombia
Phone:+57 1 3323434 ext 2405
Fax:+57 1 3323457
Email:mcalderon@minambiente.gov.co
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
ES
Tres autoridades nacionales competentes en materia de implementación del Protocolo de Cartagena sobre Seguridad de la Biotecnología: Ministerio de la Protección Social, Instituto Colombiano Agropecuario, Ministerio de Ambiente Vivienda y Desarrollo Territorial y el punto focal nacional del BCH.
Submission
10. Date of submission
2011-08-16
11. Time period covered by this report
Start date
2007-01-01
Time period covered by this report
End date
2011-06-30
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 fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more sets of biosafety guidelines
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)?
  • Partially
21. Here you may provide further details on the implementation of Article 2 in your country:
ES
Actualmente se cuenta con la reglamentación de la Ley 740 de 2002, a través del Decreto 4525 de 2005, el cual define el marco regulatorio de los organismos vivos modificados en Colombia. Las tres autoridades competentes en la materia han definido a la vez las reglamentaciones:
Ministerio de la Proteccion Social, la Resolución 227 de 2007, con el objetivo de definir el funcionamiento del Comité Tecnico Nacional de Bioseguridad para OVM de uso en salud o alimentación humana.
Instituto Colombiano Agropecuario, la Resolución 0946 de 2006, por la cual se establece el procedimiento para el trámite ante el ICA de solicitudes de Organismos Vivos Modificados, OVM; se aprueba el Reglamento Interno del Comité Técnico Nacional de Bioseguridad, CTNBio para OVM con fines exclusivamente agrícolas, pecuarios, pesqueros, plantaciones forestales comerciales y agroindustria, y se dictan otras disposiciones.
Ministerio de Ambiente, Vivienda y Desarrollo Territorial, la Resolución 957 de 2010,  por la cual se establece el procedimiento para la autorización de actividades con Organismos Vivos Modificados -OVM- con fines exclusivamente ambientales, y se adoptan otras determinaciones; y la Resolución 958 de 2010, por la cual se regula el funcionamiento del Comité Técnico Nacional de Bioseguridad para Organismos Vivos Modificados -OVM con fines exclusivamente ambientales que puedan tener efectos sobre el medio ambiente y la biodiversidad.
A la vez cada autorización o negación establecida por dichas autoridades, de cualquier actividad con OVM, se da mediante actos administrativos.
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
Esta actividad se esta realizando a través de la Sala Especializada de Medicamentos del Instituto Nacional de Vigilancia de Medicamentos y Alimentos - Invima, establecimiento público del orden nacional, de carácter científico y tecnológico, con personería jurídica, autonomía administrativa y patrimonio independiente, perteneciente al Sistema de Salud y con sujeción a las disposiciones generales que regulan su funcionamiento.
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?
  • Partially
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, to some extent
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?
  • None
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)?
  • In some cases only the BCH
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
90%
  • 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)
1%
  • Request for additional relevant information
9%
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
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?
  • Yes
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?
  • Yes
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • Yes
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
El Comité Técnico Nacional de Bioseguridad para OVM con uso en salud o alimentación humana exclusivamente -CTNSalud, ente asesor de la autoridad nacional competente en materia de salud y alimentación humana, a través de la implementación del Decreto 4525 de 2005, desarrolla el proceso de evaluación de los eventos que solicitan su autorización para ser utilizados en la industria de alimentos para consumo humano. Frente a esta situación, en aquellos eventos cuya evaluación de riesgo evidencie incertidumbre científica sobre posibles efectos adversos a la salud humana, el CTNSalud solicita ampliación de información al solicitante y de acuerdo a la evaluación realizada se otorga o no la autorización de uso. En todo caso el Comité Técnico centra sus actividades en garantizar y preservar la salud de los consumidores.
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?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
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?
  • No
73. Has your country ever applied the simplified procedure?
  • No
75. 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
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
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?
  • Yes
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?
  • In some cases only
93. Here you may provide further details on the implementation of Article 15 in your country:
ES
Acorde a lo establecido en el Decreto 4525 de 2005, los documentos de evaluación de riego se realizarán caso a caso y tendrán por objeto: identificar y valorar potenciales efectos directos e indirectos sobre la salud humana, el ambiente y la biodiversidad. El CTNBio realiza el análisis y evaluación de documentos de solicitudes para OVM con fines agrícolas, pecuarios, pesqueros, plantaciones forestales comerciales y agroindustria. El CTNSalud, realiza el análisis y la evaluación de los documentos de evaluación de riesgo que presenta el  interesado en obtener la autorización de uso en la industria de alimentos; el CTNAmbiente, los OVM con finalidad ambiental.
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
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
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?
  • No
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
El CTNSalud en el marco de las aprobaciones de uso de OVM en la industria de alimentos, solicita a cada una de las empresas presentar el respectivo documento de gestión del riesgo con el objetivo de prevenir, evitar, mitigar y controlar los posibles efectos adversos a la salud humana. 
El ICA mediante Resoluciones ha implementado los planes de manejo, bioseguridad y seguimiento para las siembras de cultivos transgénicos.     En cuanto a los OVM con fines ambientales, hasta la fecha no se ha recibido la primera solicitud.
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?
  • No
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
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
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?
  • Yes, to some extent
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
El control en puertos y pasos fronterizos a través de los cuales ingresan los OVM a nuestro país, está sujeto a la vigilancia del INVIMA quien desarrolla las actividades de inspección, vigilancia y control de estos productos.
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, to some extent
123. Here you may provide further details on the implementation of Article 19 in your country:
ES
En Colombia el Protocolo se ratificó a través de la Ley 740 de 2002 y se reglamentó mediante el Decreto 4525 de 2005 en donde se establece la función de cada una de las autoridades nacionales compententes así como el marco dentro del cual deben tomarse las decisiones sobre Organismos Vivos Modificados en el país. Cada una de las autoridades, Instituto Nacional Agropecuario (ICA), Ministerio de la Protección Social (MPS) y Ministerio de Ambiente, Vivienda y Desarrollo Territorial (MAVDT) ha venido desarrollando el marco reglamentario a través del cual es posible continuar con el proceso de toma de decisiones. Hasta la fecha se han tomado decisiones relacionadas con las dos primeras autoridades nacionales competentes (ICA y MPS) y el MAVDT participa brindando sus conceptos para autorizaciones relacionadas con organismos de interés agrícola y pecuario (potestad del ICA), los cuales no son de carácter vinculante.
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 but not 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 not available
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 not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
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 not available
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and 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 available but only partially available in the BCH
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
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 only partially available 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?
  • No
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?
  • Yes
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Yes
130. Is the information submitted by your country to the BCH complete and up-to date?
  • No
131. Here you may provide further details on the implementation of Article 20 in your country:
ES
El CIISB de Colombia se encuentra en la actualidad en proceso de actualización y migración para la utilización del aplicativo Hermes el cual es proveído por el BCH Central. Desde hace dos años el CIISB se ha mantenido con sus funcionalidades básicas de publicación de noticias sobre OVM en el mundo, presenta las autorizaciones que se realizaron en el país para uso de OVM de tipo agrícola (MADR) y en salud y alimentación humana (MPS) hasta el año 2009, 88 actos administrativos en total, pero las Autoridades Nacionales Competentes (ANC) no han informado de forma directa, como es su deber hacerlo, de las 20 decisiones nuevas que hasta diciembre de 2010 el país ha tomado.
En cuanto a las evaluaciones de riesgo el panorama es aún más desolador, solo se han publicado a través del CIISB los resumenes correspondientes a 8 evaluaciones de riesgo, lo cual corresponde a menos del 10% de las evaluaciones que deberían haber sido publicadas hasta la fecha.
Una de las razones por las cuales se decidió realizar la migración a Hermes radica en que hemos tenido problemas con el envío de la información al BCH Central, lo cual, sumado a la generación de los nuevos formatos comunes, nos llevó a la conclusión de que lo mejor era hacer en este momento la migración correspondiente; esta debe estar lista en el mes de abril para de esta forma proceder a realizar las capacitaciones correspondientes a los Usuarios Nacionales Autorizados (UNA) definidos por cada una de las ANC. Se tiene como meta que durante el segundo trimestre del año 2011 se ingresen las solicitudes que hasta hoy no han sido integradas al CIISB con el acompañamiento de la Administradora del mecanismo así como las evaluaciones de riesgo de las autorizaciones ya existentes en el CIISB y las anexas a las nuevas autorizaciones. De esta forma el CIISB debería estar actualizado en su totalidad a finales del año 2011.
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
El CTNSalud, el ente que asesora a la autoridad nacional competente para OVM de uso humano, dentro del proceso de autorizacion de OVM, cumple con las condiciones de manejo de información que las empresas solicitantes catalogan como confidencial. Sin embargo se desarrolla un documento resumen de la evaluación de riesgo el cual es sometido a consulta pública.
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?
  • Multilateral 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?
  • Multilateral 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.
  • Average
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Pilot Biosafety Enabling Activity
  • Development of national biosafety frameworks
  • Implementation of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
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
  • 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
  • Taking into account risks to human health
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?
  • No
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
Las tres autoridades nacionales competentes cuentan con un laboratorio de detección de OVM en el cual se desarrollan actividades de vigilancia y control.
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
Las autoridades nacionales competentes frente a las solicitudes de uso de OVM realizan la consulta pública respectiva, a través de la publicación en la pagina web de cada institución. Lo anterior con el objetivo de conocer las opiniones que puedan surgir frente al evento en cuestion.                                       
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
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?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • In some cases only
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
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?
  • No
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • No
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?
  • Never
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?
  • No
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
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • No
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
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
  • 2002
Here you may provide further details
ES
Para el sector agropecuario no se han asignado recursos nacionales adicionales a parte de los que el Instituto colombiano Agropecuario (ICA) tiene por funcionamiento anual. Para el sector salud y alimentación humana tampoco se han asignado recursos nacionales adicionales a parte de los que el Instituto de Vigilancia de Medicamentos y Alimentos (INVIMA) tiene por funcionamiento anual. Para el sector ambiental no se han asignado recursos adicionales a parte de los que anualmente el Ministerio de Ambiente y Desarrollo Sostenible transfiere al Instituto Humboldt para la ejecución de labores relacionadas a la implementación del Protocolo de Cartagena. Sin embargo a través del proyecto LAC-Biosafety financiado por el GEF, se transfirió a Colombia para fortalecer el tema principalmente en áreas agrícola y ambiental aproximadamente USD$1.000.000.
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 5 per year or more
Here you may provide further details
ES
Los cursos se ofrecen conjuntamente entre las tres entidades y otras organizaciones gubernamentales o del sector privado, dirigidos a funcionarios que trabajan en el tema y a público en general.
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • No
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
  • 500,000 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
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
Here you may provide further details
ES
Para el caso del sector ambiental, aunque no fueron formalmente "arreglos bilaterales", se adelantaron capacitaciones y entrenamientos en los últimos cinco años, correspondientes a acuerdos colaborativos con entidades contraparte de México (Conabio, Semarnat) y de Cuba (CNSB, MACYT), en lo cual desde el sector se han invertido importantes esfuerzos y recursos financieros y humanos.
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
El país cuenta con una reglamentación, Decreto 4525 de 2005 y Resolución ICA 946 de 2006, en los cuales se establece el procedimiento para la evaluación de riesgos. Del documento guía se han tomado algunos puntos para la evaluación de riesgos. Al igual que algunos apartes del codex alimentarius, la OECD y la ISO 24276 2006, ISTA International Rules for seed testing 2012. El sector ambiental aún no ha enfrentado evaluaciones del riesgo porque su competencia es sobre OVM de uso exclusivamente ambiental y aún no ha recibido solicitudes de ingreso de este tipo de OVM al país, por lo tanto, aún no tiene adoptada ninguna guía para la evaluación o el manejo de riesgos para OVM de uso exclusivamente ambiental. Sin embargo, actualmente se avanza en aproximaciones metodológicas que nos permitan adoptar algunos lineamientos puntuales sobre aspectos que se deben considerar para la evaluación del riesgo de este tipo OVM. El sector salud y alimentos usa en evaluación del riesgo el Codex Guidelines, pero no maneja nada guía específica para la gestión del riesgo.
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
  • Yes
Here you may provide further details
ES
El sector salud y Alimentos (INVIMA) utiliza el Codex Alimentarios Guidelines.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • Yes
Here you may provide further details
ES
Para el análisis de riesgo se han tomado algunos apartes de otros países, el INVIMA utiliza el  Codex Alimentarios Members.
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
El instituto colombiana agropecuario, ICA, de acuerdo a las competencias otorgadas en el decreto 4525 de 2005 ha realizado evaluaciones de Riesgos de organismos vivos Modificados con uso para consumo animal y para siembra en el país.
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
El ICA a través de funcionarios en las diferentes regiones del país realiza seguimiento en campo a los cultivos autorizados modificados genéticamente, así mismo se cuenta con un el Laboratorio Central Interinstitucional de Detección y  Monitoreo de OGM, que tiene la capacidad de identificar los eventos transgénicos autorizados para uso en el país.
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
  • Yes
Here you may provide further details
ES
El ICA tiene diferentes resoluciones, como por ejemplo la resolución 970 de 2010, establece los requisitos de etiquetado que deben cumplir las semillas, la Resolución 2894 de 2010. Por medio de la cual se implementa el Plan de manejo, bioseguridad y seguimiento para siembras controladas de maíz y la Resolución 682 de 2009 para algodón, establece parámetros con el fin de mantener medidas de bioseguridad que permitan un mejor manejo y control de la seguridad que los OVM deben tener  El INVIMA tiene la Resolución 4254 del 2011 la cual aborda este tema para el caso de OVM para uso en Alimentación Humana.  El sector ambiental aún no posee normativa al respecto.
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
  • No
Here you may provide further details
ES
En el país como en la mayoría de Partes del Protocolo, el tema de consideraciones socioeconómicas (Art. 26 PC) y su incorporación en el proceso de toma de decisiones sobre OGM se encuentra en una fase de discusión, que permita definir los alcances de tales consideraciones y su incorporación en la toma de decisiones. A efecto de lo anterior, el país ha participado activamente en los Foros en Línea adelantados por la Secretaria del Convenio, tanto en el Foro Global como en el Foro para Latinoamerica desarrollados en los años 2011 y 2013.
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
  • None
Here you may provide further details
ES
Sin embargo, Colombia a través del Instituto de Investigación de Recursos Biológicos Alexander von Humboldt, ha avanzado en la elaboración de propuestas para la definición de una ruta metodológica para la evaluación de consideraciones socioeconómicas en el proceso de adopción de decisiones sobre OGM, con el objeto de construir un instrumento que permita analizar las consideraciones socioeconómicas y determinar los posibles riesgos socioeconómicos, resultantes de los efectos de la liberación de Organismos Vivos Modificados sobre la conservación y la utilización sostenible de biodiversidad y sobre el valor que la biodiversidad representa para las comunidades y locales.
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
Desde el sector agropecuario no se tiene experiencia. Desde el sector ambiental ninguna experiencia práctica, solo acercamientos teóricos, que se espera permitan a futuro consolidar una ruta metodológica, que permita que de manera rigurosa y sistemática se aborden las consideraciones socio económicas y su incorporación en el proceso de adopción de decisiones.
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
Se cuenta con un laboratorio interinstitucional ICA - INVIMA - Ministerio de Ambiente (operado por el Instituto Humboldt) y profesionales en las diferentes regiones para la identificación de eventos no autorizados. Así mismo, en puertos y aeropuertos se hace el primer filtro para controlar el ingreso de granos y semillas. Desde la perspectiva de alimentación humana, si un evento no aprobado entra al país, INVIMA está en capacidad de tomar las medidas apropiadas.  Por otra parte desde el sector ambiental se vienen desarrollando actividades de caracterización genética de especies silvestres emparentadas con OGM, investigación y capacitación en bioseguridad para el sector ambiental, colecta y  conservación de material genético de especies silvestres emparentadas con OGM, con la finalidad de contar con una adecuada Línea Base en el país.
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
  • 10 or more
Survey 19.b) Monitoring
  • 50 or more
Survey 19.c) Management / Control
  • 10 or more
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
Se cuenta con un laboratorio interinstitucional ICA - INVIMA - Ministerio de Ambiente-Instituto Humboldt.
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
  • No
Here you may provide further details
ES
Las capacitaciones se realizan cumpliendo con lo establecido en la normatividad vigente y siguiendo los lineamientos generales para la evaluación y gestión del riesgo. Para cada actividad de entrenamiento se elaboran previamente los materiales respectivos.
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
  • Yes
Here you may provide further details
ES
Suficiente solo para el sector agropecuario, para salud y alimentación humana Colombia considera que no existen materiales suficientes ni efectivos.
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • 10 or more
Here you may provide further details
ES
INVIMA tiene entrenamiento gradual y continuo de su personal ubicado en puertos, aeropuertos y puntos fronterizos.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 10 or more
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • None
Here you may provide further details
ES
INVIMA está en el proceso de acreditación por ISO/IEC 17025:2005, sin embargo es el  Laboratorio Nacional de Referencia.
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • None
Here you may provide further details
ES
No obstante, con base a la anterior respuesta el laboratorio es operacional y está en proceso de certificación.
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
  • Yes
Here you may provide further details
ES
Para el sector agropecuario sí.  Para el sector ambiental no ya que hasta ahora está el proceso de ratificación del Protocolo de N-KL.
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
  • No
Here you may provide further details
ES
Explícitamente no, aunque el régimen sancionatorio ambiental (Ley 1333 de 2009), considera medidas frente a daños en el medio ambiente y biodiversidad por el desarrollo de cualquier proyecto, obra o actividad, dentro de los cual se podría incluir daños derivados por el uso de OGM.
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
A través de conferencias, seminarios y a través de la página web del ICA se ha informado de todo lo relacionado con los OVM.  Desde el sector ambiental no se ha abordado de manera específica las modalidades existentes para la participación del público en la toma de decisiones.
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
  • Forums
  • Mailing lists
  • Public hearings
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • 3 or more
Here you may provide further details
ES
El personal del INVIMA dicta conferencias en la Universidad de los Andes, al menos, una vez al  año. La Universidad Nacional también ofrece un diploma de postgrado en seguridad de la  biotecnología desde el 2008. El Ministerio de Salud está trabajando en conjunto con la  Universidad Antonio Nariño para la formación de los docentes en materia de bioseguridad.
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • One or more
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
  • No
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
  • 10 or more
Here you may provide further details
ES
Se han organizado eventos regionales.
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
  • 10 or more
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • Se proporciona en las paginas institucionales y en el BCH.
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
INVIMA está liderando la conformación de la Red Latinoamericana y del Caribe de Laboratorios  de detección de OGM
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
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
ICA de impacto local  El Ministerio de Salud está trabajando en conjunto con la Universidad Antonio Nariño para la formación de los docentes en materia de bioseguridad.
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
El Ministerio de Salud y el INVIMA han establecido una estrategia de comunicación con la  industria y el público a través de seminarios y reuniones de todo el país, el aumento de la  conciencia pública y el conocimiento nacional de políticas.
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • One or more
Here you may provide further details
ES
Algunos de los materiales del proyecto GEF-Banco Mundial para la implementación del Protocolo  de Cartagena están todavía disponibles. También INVIMA desarrolló un folleto sobre el ABC de  los alimentos GM, que está disponibles en formato electrónico ya que todas las copias físicas  fueron distribuidas.