Malawi | BCH-NR4-MW-248065 | Fourth National Report on the Implementation of the Cartagena Protocol on Biosafety

General Information

Country

Malawi

Contact person submitting the report

CHM-NFP-MW-238264-7 National Focal Points Dr. Lilian Chimphepo This document has been updated. This is not the latest published version. Click here to view the latest version of the record.

9. Organizations/stakeholders who were consulted or participated in the preparation of this report

Lilongwe University of Agriculture and Natural Resources (LUANAR), Department of Agriculture and Research Services, Forestry Research Institute of Malawi (FRIM), Malawi Bureau of Standards (MBS), Malawi Revenue Authority (MRA), Ministry of Gender, Ministry of Health, Ministry of Trade, Ministry of Labour, Lilongwe Wildlife Trust (LWT), Malawi Police Services (MPS), Environmental Affairs Department (EAD), Fisheries Department, National Commission of Science and Technology (NCST), Programme for Biosafety Systems (PBS), Cotton Council of Malawi.

EN

10. Time period covered by this report

From

01 Oct 2015

To

30 Sep 2019

Party to the Cartagena Protocol on Biosafety

11. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?

Yes

EN

Article 2 – General provisions

Article 2 requires each Party to take the necessary and appropriate legal, administrative and other measures to implement its obligations under the Protocol

14. Has your country introduced the necessary national measures for the implementation of the Protocol?

National measures are fully in place

EN

15. Which specific instruments are in place for the implementation of national biosafety measures? (select all that apply)

One or more national biosafety laws
One or more national biosafety regulations
Other laws, regulations or guidelines that indirectly apply to biosafety

16. Has your country undertaken initiatives to mainstream biosafety into national biodiversity strategies and action plans, other policies, or legislation?

Yes

EN

viewNationalReportT.additionalInformation

Target 14 of the NBSAP focuses on strengthening the level of protection on safe handling, transfer and use of living modified organisms resulting from modern biotechnology that may have adverse impact on biodiversity taking into account risks to human health. Department of Fisheries that does not allow live exotic fish species into the country. furthermore, there is a requirement by law to label any product that comes into the country indicating whether or not it contains GMO

EN

17. Has your country established a mechanism for budget allocations for the operation of its national biosafety measures?

Yes, to some extent

EN

viewNationalReportT.additionalInformation

Some resources are allocated for monitoring compliance to Biosafety Law and Regulations

EN

18. Does your country have permanent staff to administer functions directly related to biosafety?

Yes

EN

19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to biosafety ?

10 or more

EN

Is this number adequate

No

EN

20. Here you may provide further details on the implementation of Article 2 in your country

Although the country has more than 10 members of staff in different institutions that are working on Biosafety, the porous nature of our borders makes it difficult to effectively monitor the entry of living modified organisms. Therefore, more staff are required. There is also need to enhance capacity of the existing members of staff. Apart from the legal framework under the custody of the National Competent Authority, other policies and legislations exist in other institutions that have direct bearing on LMOs entry, production, use and handling in the country.

EN

Article 5 - Pharmaceuticals

21. Does your country regulate the transboundary movement, handling or use of living modified organisms (LMOs) which are pharmaceuticals to humans?

Yes

EN

22. Here you may provide further details on the implementation of Article 5 in your country

Although the Biosafety Act has provisions for regulating the transboundary movement, handling or use of LMOs which are pharmaceutical, its implementation remains a challenge. the Pharmacy, Medicine and Poisons Board is mandated to regulate pharmaceuticals, the linkages with biosafety is not very clear.

EN

Article 6 – Transit and Contained use

23. Does your country regulate the transit of LMOs?

Yes

EN

24. Does your country regulate the contained use of LMOs?

Yes

EN

25. Has your country taken a decision concerning the import of LMOs for contained use?

Yes

EN

26. Here you may provide further details on the implementation of Article 6 in your country

The country had taken some decisions concerning importation of LMOs for contained use in 2019 and all the relevant information is available but have not been submitted on the BCH.

EN

Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment

27. 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

EN

28. When acting as the Party of export, has your country established legal requirements for the accuracy of information contained in the notification provided by the exporter?

Yes

EN

29. In the current reporting period, has your country received a notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?

No

EN

30. If you answered Yes to question 29, did the notification(s) contain complete information (at a minimum the information specified in Annex I to the Cartagena Protocol on Biosafety)?

31. If you answered Yes to question 29, has your country acknowledged receipt of the notification(s) to the notifier within ninety days of receipt?

32. If you answered Yes to question 29, has your country informed of its decision(s)

a. The notifier?

b. The Biosafety Clearing-House (BCH)?

33. In the current reporting period, has your country taken a decision in response to the notification(s) regarding intentional transboundary movements of LMOs for intentional introduction into the environment?

Yes

EN

34. If you answered Yes to question 33, how many LMOs has your country approved for import for intentional introduction into the environment?

1 to 4

EN

35. If you answered under question 34 that LMOs were approved, have all these LMOs actually been imported into your country?

Yes, always

EN

36. If you answered Yes to question 33, what percentage of your country’s decisions fall into the following categories? (select all that apply)

Approval of the import/use of the LMO(s) with conditions (100)

37. If you answered under question 36 that your country has taken a decision to approve the import with conditions or to prohibit the import, were the reasons provided?

Yes, always

EN

38. Here you may provide further details on the implementation of Articles 7 to 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

Importation of LMO for confined field trials always approved with conditions.

EN

Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)

39. Does your country have law(s), regulation(s) or administrative measures for decision-making regarding domestic use, including placing on the market, of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing?

Yes

EN

40. Has your country established legal requirements for the accuracy of information to be provided by the applicant regarding the domestic use, including placing on the market, of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing?

Yes

EN

41. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing?

None

EN

42. Does your country have law(s), regulation(s) or administrative measures for decision-making regarding the import of LMOs for direct use as food or feed, or for processing?

Yes

EN

43. In the current reporting period, how many decisions has your country taken regarding the import of LMOs for direct use as food or feed, or for processing?

None

EN

44. 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 that may be subject to transboundary movement for direct use as food or feed, or for processing

Article 12 – Review of decision

45. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?

Yes

EN

46. In the current reporting period, has your country reviewed and/or changed a decision regarding an intentional transboundary movement of an LMO?

No

EN

47. If you answered Yes to question 46, how many decisions were reviewed and/or changed?

48. If you answered Yes to question 46, were any of the reviews triggered by a request from the Party of export or the notifier?

49. If you answered Yes to question 48, did your country provide a response within ninety days setting out the reasons for the decision?

50. If you answered Yes to question 46, were any of the reviews initiated by your country as the Party of import?

51. If you answered Yes to question 50, did your country, within thirty days, set out the reasons for the decision and inform

a. The notifier

b. The BCH?

52. Here you may provide further details on the implementation of Article 12 in your country

Article 13 – Simplified procedure

53. Has your country established a mechanism for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?

No

EN

54. In the current reporting period, has your country applied the simplified procedure?

No

EN

55. If you answered Yes to question 54, for how many LMOs has your country applied the simplified procedure?

56. If you answered Yes to question 54, has your country informed the Parties through the BCH of the cases where the simplified procedure was applied?

57. Here you may provide further details on the implementation of Article 13 in your country

Article 14 – Bilateral, regional and multilateral agreements and arrangements

58. How many bilateral, regional or multilateral agreements or arrangements relevant to biosafety has your country established with other Parties/non-Parties?

1 to 4

EN

59. If you answered under question 58 that agreements or arrangements were established, please provide a brief description of their scope and objective

1. There is an arrangement with PBS to support the country to build capacity in implementation of the biosafety legal framework. 2. The country has an arrangement with NEPAD to support capacity build initiative of the NBRC in biosafety and biotechnology

EN

60. Here you may provide further details on the implementation of Article 14 in your country

Articles 15 & 16 – Risk Assessment and Risk Management

61. Does the domestic regulatory framework of your country require risk assessments of LMOs to be conducted?

Yes

EN

62. If you answered Yes to question 61, with regard to which LMOs does the requirement apply (select all that apply)?

For imports of LMOs for intentional introduction into the environment
For imports of LMOs intended for direct use as food or feed, or for processing
For decisions regarding domestic use, including placing on the market, of LMOs that may be subject to transboundary movements for direct use as food or feed, or for processing
For imports of LMOs for contained use

63. Has your country established a mechanism to conduct risk assessments prior to taking decisions regarding LMOs?

Yes

EN

64. If you answered Yes to question 63, does the mechanism include procedures to identify and/or train national experts to conduct risk assessments?

Yes

EN

Capacity-building in risk assessment or risk management

65. How many people in your country have been trained in risk assessment, risk management and monitoring of LMOs?

a. Risk assessment

1 to 9

EN

Is this number adequate

No

EN

b. Risk management

1 to 9

EN

Is this number adequate

No

EN

c. Monitoring

1 to 9

EN

Is this number adequate

No

EN

66. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?

Yes

EN

67. If you answered Yes to question 66, is your country using the “Manual on Risk Assessment of LMOs” (developed by the CBD Secretariat) for training in risk assessment?

No

EN

68. If you answered Yes to question 66, 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?

No

EN

69. Does your country have specific needs for further guidance on specific topics of risk assessment of LMOs?

Yes

EN

viewNationalReportT.additionalInformation

The country needs a full training package because the National Biosafety Regulatory Committee has been reconstituted and the new members need to be trained as well. Advances in technologies also means that experts need regular training to get familiarized with new and emerging technologies

EN

70. Does your country have the capacity to detect, identify, assess the risk of 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?

a. Detect

Yes

EN

b. Identify

Yes

EN

c. Assess the risk

Yes

EN

d. Monitor

Yes

EN

Conducting risk assessment or risk management

71. 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?

a. Risk assessment

Yes

EN

b. Risk management

Yes

EN

72. If you answered Yes to question 71, 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?

No

EN

73. Has your country adopted common approaches or methodologies to risk assessment in coordination with other countries?

No

EN

74. 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

EN

75. In the current reporting period, has your country conducted any kind of risk assessment of LMOs, including for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?

No

EN

76. If you answered Yes to question 75, how many risk assessments were conducted?

77. If you answered Yes to question 75, please indicate the scope of the risk assessments (select all that apply)

78. If you answered Yes to question 75, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing?

79. Has your country established appropriate mechanisms, measures and strategies to regulate and manage risks identified in the risk assessment of LMOs?

Yes

EN

80. Has your country taken appropriate measures to prevent unintentional transboundary movements of LMOs, including such measures as requiring a risk assessment to be carried out prior to the first release of a LMO?

Yes

EN

81. 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

EN

82. Has your country established a mechanism for monitoring potential effects of LMOs released into the environment?

Yes

EN

83. Does your country have the necessary infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?

Yes

EN

84. Here you may provide further details on the implementation of Articles 15 and 16 in your country

The country is participating in the Multi-country project aimed at building capacity of Laboratories in LMO testing in support of national biosafety decision making. Two laboratories are participating in this project. The project has procured basic equipment for LMO testing and is going to train lab technicians in LMO sampling and testing.

EN

Article 17 – Unintentional transboundary movements² and emergency measures

² In accordance with the operational definition adopted in decision CP-VIII/16, “‘Unintentional transboundary movement’ is a transboundary movement of a living modified organism that has inadvertently crossed the national borders of a Party where the living modified organism was released, and the requirements of Article 17 of the Protocol apply to such transboundary movements only if the living modified organism involved is likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, in the affected or potentially affected States.”

85. Has your country established measures to notify affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations in case of a release under its jurisdiction that leads, or may lead, to an unintentional transboundary movement?

Yes

EN

86. In the current reporting period, how many releases of LMOs occurred under your country’s jurisdiction that led, or may have led, to an unintentional transboundary movement?

None

EN

87. If you answered under question 86 that a release occurred, has your country notified affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations?

88. Does your country have the capacity to take appropriate response measures in response to unintentional transboundary movements?

Yes

EN

89. In the current reporting period, how many times has your country become aware of an unintentional transboundary movement into its territory?

None

EN

90. Here you may provide further details on the implementation of Article 17 in your country

The country need to build more capacity in LMO detection not only for the lab personnel but also the customs staff in all the boarders of the country. Since our boarders are porous there is urgent need to enhance collaboration with all neighboring countries for effective implementation of the protocol.

EN

Article 18 – Handling, transport, packaging and identification

91. 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

EN

92. Has your country taken measures to require that documentation accompanying LMOs-FFP, in cases where the identity of the LMOs is not known, clearly identifies that they may contain LMOs and are not intended for intentional introduction into the environment, as well as a contact point for further information?

Yes

EN

93. Has your country taken measures to require that documentation accompanying LMOs-FFP, in cases where the identity of the LMOs is known, clearly identifies that they contain LMOs and are not intended for intentional introduction into the environment, as well as a contact point for further information?

Yes

EN

94. If you answered Yes to question(s) 91, 92 and/or 93, what type of documentation accompanying LMOs does your country require?

Documentation specific for LMOs

EN

95. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as LMOs 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

EN

96. If you answered Yes to question 95, what type of documentation does your country require for the identification of LMOs that are destined for contained use?

Documentation specific for LMOs

EN

97. 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

EN

98. If you answered Yes to question 97, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?

Documentation specific for LMOs

EN

99. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?

Yes

EN

100. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?

Yes

EN

101. How many customs officers in your country have received training in the identification of LMOs?

1 to 9

EN

Is this number adequate

No

EN

102. Has your country established procedures for the sampling and detection of LMOs?

Yes, to some extent

EN

103. How many laboratory personnel in your country have received training in detection of LMOs?

1 to 9

EN

Is this number adequate

No

EN

104. Does your country have reliable access to laboratory facilities for the detection of LMOs?

Yes

EN

105. How many laboratories in your country are certified for LMO detection?

None

EN

106. If you answered under question 105 that certified laboratories exist in your country, how many of them are currently operating in the detection of LMOs?

107. Here you may provide further details on the implementation of Article 18 in your country

The training was done over six year ago and some of the customs officers trained have been transferred hence the need to train the new staff in all the boarders on biosafety and identification of LMOs.

EN

Article 19 – Competent National Authorities and National Focal Points

108. 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?

Not applicable (only one competent national authority was designated)

EN

109. 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

EN

110. Has your country undertaken initiatives to strengthen collaboration among national focal points, competent national authority(ies) and other institutions on biosafety-related matters?

Yes

EN

viewNationalReportT.additionalInformation

the National Biosafety Regulatory Committee (NBRC)comprises of representatives from various sectors that are key in biosafety issues. The country under the BCHIII project has trained stakeholders including members of the NBRC on the use of the BCH in finding information, registering and using the BCH to search for resource materials for training on biosafety. furthermore, some of the sectors have nominated focal points which are designated users of the BCH.

EN

111. Here you may provide further details on the implementation of Article 19 in your country

Institutions that will be included as national authorized users have been identified and will soon be registered on the BCH

EN

Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)

112. 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.

a. Existing 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

EN

b. Legislation, 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

EN

c. Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))

Information available but not in the BCH

EN

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

EN

e. Decisions by a Party regarding transit of LMOs (Article 6, paragraph 1)

Information available but not in the BCH

EN

f. Decisions by a Party regarding import of LMOs for contained use (Article 6, paragraph 2)

Information available but not in the BCH

EN

g. Notifications regarding the release under your country’s jurisdiction that leads, or may lead, to an unintentional transboundary movement of a LMO that is likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)

Information not available

EN

h. Information concerning cases of illegal transboundary movements of LMOs (Article 25, paragraph 3)

Information not available

EN

i. Decisions regarding the importation of LMOs for intentional introduction into the environment (Article 10, paragraph 3)

Information available but not in the BCH

EN

j. Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)

Information available but not in the BCH

EN

k. 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 not available

EN

l. 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 to the Protocol (Article 11, paragraph 6)

Information available but not in the BCH

EN

m. Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)

Information not available

EN

n. Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)

Information not available

EN

o. 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 (a))

Information not available

EN

p. LMOs granted exemption status by each Party (Article 13, paragraph 1 (b))

Information not available

EN

q. Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))

Information available but not in the BCH

EN

113. Please provide a brief explanation if you answered that the information is available but not in the BCH or only partially available in the BCH to any item under question 112:

114. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?

Yes

EN

115. 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

EN

116. Does your country use the information available in the BCH in its decision making processes on LMOs?

Yes, in some cases

EN

117. Has your country experienced difficulties accessing or using the BCH?

No

EN

118. In the current reporting period, how many biosafety-related events (e.g. seminars, workshops, press conferences, educational events) has your country organized?

10 to 24

EN

119. In the current reporting period, how many biosafety-related publications has your country published?

1 to 9

EN

120. Here you may provide further details on the implementation of Article 20 in your country

The country has organized several workshop under the Mult-country Project for LMO detection and other meetings supported by partners such as NEPAD and PBS which included refresher trainings on food and feed safety, genome editing and risk assessment among others. Under the LMO detection project the country has produced a newsletter on Biosafety.

EN

Article 21 – Confidential information

121. Has your country established procedures to protect confidential information received under the Protocol?

Yes

EN

122. Does your country allow the notifier to identify information that is to be treated as confidential?

In some cases only

EN

123. Here you may provide further details on the implementation of Article 21 in your country

Information is treated as confidential if it is in conformity with the Biosafety Act

EN

Article 22 – Capacity-building

124. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?

No

EN

125. 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

EN

126. If you answered Yes to question 125, how were these resources made available? (select all that apply)

Multilateral channels

127. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?

No

EN

128. If you answered Yes to question 127, how were these resources made available? (select all that apply)

129. In the reporting period, has your country initiated a process to access funds from the Global Environment Facility (GEF) for building capacity in biosafety?

Yes

EN

viewNationalReportT.additionalInformation

The country developed a concept to source funding for revision of the Biosafety Act and Regulations from GEF however it was not successful since the funds were inadequate and impact programmes were prioritized.

EN

130. If you answered Yes to question 129, how would you characterize the process?

Difficult

EN

131. In the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?

Yes

EN

132. If you answered Yes to question 131, in which of the following areas were these activities undertaken (select all that apply)?

Institutional capacity and human resources
Integration of biosafety in cross-sectoral and sectoral legislation, policies and institutions (mainstreaming biosafety)
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
Identification of LMOs, including their detection
Liability and redress

133. In the current reporting period, has your country carried out a capacity-building needs assessment?

Yes

EN

134. Does your country still have capacity-building needs?

Yes

EN

135. If you answered Yes to question 134, which of the following areas still need capacity-building (select all that apply)?

Institutional capacity and human resources
Integration of biosafety in cross-sectoral and sectoral legislation, policies and institutions (mainstreaming biosafety)
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
Technology transfer
Sampling, detection and identification of LMOs
Socio-economic considerations
Implementation of the documentation requirements for handling, transport, packaging and identification
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
Liability and redress

136. Has your country developed a capacity-building strategy or action plan?

No

EN

137. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?

Yes

EN

138. 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:

Accessing GEF funds for biosafety activities is a very big challenge.

EN

Article 23 – Public awareness and participation

139. Is biosafety public awareness, education and/or participation addressed in legislation or policy in your country?

Yes

EN

140. In the current reporting period, has your country cooperated with other States and international bodies in relation to public awareness, education and participation?

No

EN

141. Has your country established a mechanism to ensure public access to information on LMOs?

Yes, to some extent

EN

viewNationalReportT.additionalInformation

The Biosafety Act requires that any person intending to carry out activities involving LMOs has to publish in two common local newspapers to get views from the general public. This is however not adequate thus the need to revised legal provisions under access to information on LMOs in the Biosafety Act or Regulations.

EN

142. Does your country have in place a national communication strategy on biosafety?

Yes

EN

viewNationalReportT.additionalInformation

In draft form but implementable

EN

143. Does your country have any awareness and outreach programmes on biosafety?

Yes

EN

144. Does your country currently have a national biosafety website?

Yes

EN

145. How many academic institutions in your country are offering biosafety education and training courses and programmes?

1 to 4

EN

Is this number adequate

No

EN

146. How many educational materials and/or online modules on biosafety are available and accessible to the public in your country?

1 to 4

EN

Is this number adequate

No

EN

147. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?

Yes

EN

148. Has your country informed the public about existing modalities for public participation in the decision-making process regarding LMOs?

Yes, to some extent

EN

viewNationalReportT.additionalInformation

Once they have any concerns on proposed activities regarding LMOs, the public can submit their concerns to the Biosafety Registrar and these are taken into consideration during the evaluation of the dossier by the National Biosafety regulatory Committee.

EN

149. If you answered Yes to question 148, please indicate the modalities used to inform the public: (select all that apply)

150. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs?

Not applicable (no decisions were taken)

EN

151. Has your country informed the public about the means to access the Biosafety Clearing-House?

Yes

EN

152. Here you may provide further details on the implementation of Article 23 in your country

Under the BCHIII project stakeholders were trained on how they can access information on the Biosafety Clearing House. These stakeholders were drawn from various sectors including Non-Governmental Organizations who directly work with the general public on information sharing

EN

Article 24 – Non-Parties

153. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?

No

EN

154. In the current reporting period, has your country imported LMOs from a non-Party?

No

EN

155. In the current reporting period, has your country exported LMOs to a non-Party?

No

EN

156. If you answered Yes to question 154 and/or 155, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?

157. Here you may provide further details on the implementation of Article 24 in your country

Article 25 – Illegal transboundary movements³

³In accordance with the operational definition adopted in decision CP VIII/16, “‘Illegal transboundary movement’ is a transboundary movement of living modified organisms carried out in contravention of the domestic measures to implement the Protocol that have been adopted by the Party concerned”.

158. 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 the Cartagena Protocol?

Yes

EN

159. In the current reporting period, how many cases of illegal transboundary movements of LMOs has your country become aware of?

None

EN

160. If you indicated under question 159 that your country became aware of cases of illegal transboundary movements, has the origin of the LMO(s) been established?

161. Here you may provide further details on the implementation of Article 25 in your country

Article 26 – Socio-economic considerations

162. Does your country have any specific approaches or requirements that facilitate how socioeconomic considerations should be taken into account in LMO decision-making?

Yes

EN

163. In the current reporting period, have socioeconomic considerations arising from the impact of LMOs been taken into account in decision-making?

Not applicable (no decisions were taken)

EN

164. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socioeconomic considerations?

None

EN

Is this number adequate

165. Has your country cooperated with other Parties on research and information exchange on any socioeconomic impacts of LMOs?

No

EN

166. Here you may provide further details on the implementation of Article 26 in your country

This one of the areas where the country need capacity building and prioritization of the aspects of socioeconomics to be considered.

EN

Article 28 – Financial Mechanism and Resources

167. In the current reporting period, how much funding (in the equivalent of US dollars) has your country mobilized to support implementation of the Cartagena Protocol beyond the regular national budgetary allocation?

100,000 to 499,000 USD

EN

Article 33 – Monitoring and reporting

Article 33 requires Parties to monitor the implementation of its obligations under the Cartagena Protocol and to report to the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on measures taken to implement the Protocol

168. Does your country have in place a system to monitor and enforce the implementation of the Cartagena Protocol?

Yes

EN

Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress

Parties to the Cartagena Protocol that are not yet Party to the Supplementary Protocol are also invited to respond to the questions below

169. Is your country a Party to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?

No

EN

170. If you answered No to question 169, is there any national process in place towards becoming a Party to the Supplementary Protocol?

Yes

EN

171. Has your country introduced the necessary measures for the implementation of the Supplementary Protocol?

National measures are partially in place

EN

172. Which instruments are in place for the implementation of the Supplementary Protocol?

One or more national regulations

EN

viewNationalReportT.additionalInformation

Biosafety regulations 21(2) indicates that the operator will be liable to any damage to the environment or biodiversity caused by use or release of genetically modified organism.

EN

173. Does your country have administrative or legal instruments that require response measures to be taken

a. In case of damage resulting from LMOs?

Yes

EN

b. In case there is sufficient likelihood that damage will result if response measures are not taken?

Yes

EN

174. If you answered Yes to question 173a, do these instruments impose requirements on an operator (select all that apply)?

Yes, the operator must inform the competent authority of the damage
Yes, the operator must evaluate the damage
Yes, the operator must take response measures

175. If you answered Yes to question 173a, do these instruments require the operator to take response measures to avoid damage?

Yes

EN

176. If you answered Yes to question 173a or 173b, do these instruments provide for a definition of “operator”?

Yes

EN

177. If you answered Yes to question 176, which of the following could be an ‘operator’ (select all that apply)?

Permit holder
Person who placed the LMO on the market
Developer
Exporter
Importer

178. Has a competent authority been identified for carrying out the functions set out in the Supplementary Protocol?

No

EN

179. If you answered Yes to question 178, what measures may the competent authority take (select all that apply)?

180. Does your country have measures in place to provide for financial security for damage resulting from LMOs?

No

EN

181. If you answered Yes to question 180, what type of financial security measures are in place (select all that apply)?

182. Does your country have rules and procedures on civil liability that address damage resulting from LMOs, or has such damage been recognized in court rulings (select all that apply)?

Yes, in a civil liability instrument

183. Have there been any occurrences of damage resulting from LMOs in your country?

No

EN

184. If you answered Yes to question 183, have response measures been taken?

185. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress

The country is currently using the Polluter Pays principle until the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress is ratified. However, a cabinet paper on ratifying the Protocol was drafted and submitted to Cabinet for consideration. Consultations with other legal experts are in the final stages.

EN

Other information

186. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.

Limited financial support is the major challenge hindering effective implementation of the Protocol at national level. The legal analysis conducted in 2015 revealed a lot of gaps in the biosafety legal framework that need to be revised to strengthen the legislations to enhance compliance to implementation of the Protocol.

EN

Comments on reporting format

187. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.

Generally the reporting template is user friendly. The only missing information noted was on questions on number of staff trained in various subjects where the focus was only on numbers trained and not on the period when the training was acquired. The information on timeframe for the training is important as it may guide which subject or target groups need refresher trainings in future. Examples need sub question for question 65

EN

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