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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109114
Status
Published
Date of creation
2015-10-30 16:34 UTC (jmuchiri@biosafetykenya.go.ke)
Date of publication
2015-10-30 19:18 UTC (dogoyi@biosafetykenya.go.ke)

Origin of report
1. Country
  • Kenya
Contact officer for report
Coordinates
Dr. Willy Tonui
Chief Executive Officer and NFP to the Cartagena Protocol on Biosafety
National Biosafety Authority (NBA)
P.O. Box 28251
Nairobi, Nairobi
Kenya, 00100
Phone:+254 721 283 353/ +254 713 854 132
Email:ceo@biosafetykenya.go.ke
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
KEPHIS, DVS, DPH, PCPB, KEBS, KIPI, NEMA, KWS, AATF, ABSF
Submission
10. Date of submission
2015-10-30
11. Time period covered by this report
Start date
2011-10-01
11. Time period covered by this report
End date
2015-10-30
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is fully in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2009
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country
Kenya signed the Cartagena Protocol in 2000 and ratified in 2003. Kenya approved the National Biotechnology Policy in 2006, enacted the Biosafety Act in 2009, established the National Biosafety Authority in 2010. Regulations have been developed and published for contained use (2011), environmental release (2011), imports, exports and transit (2011) as well as labelling (2012). Regulations for handling, packaging, transporting and storage of GMOs are at an advanced stage of development.
Article 5 - Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • No
24. Here you may provide further details on the implementation of Article 5 in your country:
The Biosafety Act No. 2009 as well as the Biosafety Regulations exempts GMOs that are pharmaceutical for human use. These are regulated by other laws in Kenya such as the Pharmacy and Poisons Board Act.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • Yes
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Partially
28. Here you may provide further details on the implementation of Article 6 in your country:
NBA has made approvals for LMOs (for research experiments) and derived products of LMOs for FFP. All approvals for research were experiments at laboratory, greenhouse and confined field trials. The major target crops are maize, cassava, sorghum, sweet potato, cotton and Gypsophila cut flower. These products have not been commercialized and do not posses a unique identifier or code for us to register information/decisions directly to the BCH. The only risk assessment and decisions posted directly to the BCH was on confined field trial of Mon 810 Bt Maize which have been assigned a unique identifier by OECD. Kenya however posts all decisions in the national BCH and NBA website http://www.biosafetykenya.go.ke that is linked to the BCH. Posting is done within 30 days after a decision is made on a GMO application.

Approvals for transit were LMO-FFP of corn and corn-soya blend to neighbouring countries for humanitarian assistance. There were no approvals for transit of living modified organisms during the reporting period.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • Yes
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • No
38. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Less than 5
39. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
46. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment
Kenya has enacted Biosafety Regulations on Environmental Release and placing on the market of GMOs. The country has also developed Guidelines for environmental risk assessment for GMOs meant for the environment. The Authority is currently reviewing two applications (Bt Cotton and Mon 810 Maize) for environmental release but a decision is yet to be made.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • Yes
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
53. How many LMOs-FFP has your country approved to date?
  • More than 10
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • No
57. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • No
58. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP
Decisions made were only for imports in relation to food aid and not for placing in the market. All approved products were processed/milled prior to import (Not LMOs in the definition of the Protocol). Since the approvals were products from USA, there was no mechanism to specify which particular event was in the imports rather it was a blend of all events approved in USA for corn and soybean. Our sharing of information on approved LMOs-FFP is only though the National Biosafety Clearing House portal in the NBA website http://www.biosafetykenya.go.ke which is linked to the international BCH.
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
60. Has your country ever received a request for a review of a decision?
  • No
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
66. Here you may provide further details on the implementation of Article 12 in your country
The Biosafety Act gives the National Biosafety Authority power to review approval conditions it has given to a grantee. In compliance with the Biosafety Act, the Kenyan Government appointed a 5-member Appeals Tribunal in August 2014 to review all cases of appeals in regard to a decision taken by the Authority. The Biosafety Act also provides mechanisms for appeals through a court of law (High Court) if one is dissatisfied with the decision of an appeals Tribunal. The decision of the High Court is final.

To-date, the NBA has, in a number of instances (about 3), reviewed approval conditions (amendment to approval conditions) but there has not been any review of an overall decision as no grantee/authorized party has ever contested a decision. As such, no decision has been reviewed neither by the Appeals Tribunal nor the High Court.
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
68. Has your country ever applied the simplified procedure?
  • No
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
71. Here you may provide further details on the implementation of Article 13 in your country
The current regulatory framework provides for a single form for import, export and transit of GMOs and derived products; as such there is no provision for a simplified procedure. 
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
76. Here you may provide further details on the implementation of Article 14 in your country
Initiatives to harmonize biosafety regulations and risk assessments of GMOs within the East African Community and COMESA regions are at an infancy stage. As such no concrete binding agreements have been finalized.
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
  • Yes
79. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
This question is relevant to indicator 2.2.3 of the Strategic Plan
a) Risk assessment:
  • 10 or more
b) Management / Control:
  • 10 or more
c) Monitoring:
  • 10 or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • Yes
84. Does your country have the capacity to detect, identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • Yes
88. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • No
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Field trial
  • LMOs for Contained use
  • LMOs for direct use as food
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?
  • Yes, always
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
  • More than 10
94. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
This question is relevant to indicator 2.2.4 of the Strategic Plan
  • Yes
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
The country uses a number of Guidelines and online searches in conducting risk assessment of GMOs, one of them being the AHTEG draft on Risk assessment and Risk Management. Kenya has actively participated in the online discussions on the improvement of the draft Guidance Document on Risk assessment and risk management. There is need for simplification of the document for use by regulators and risk assessors as well as capacity building to our expert reviewers (Roster of experts) on risk assessment of emerging GMOs such as GM animals and more so on GM arthropods.

The approvals for imports required prior milling as a condition before import, so essentially they were not LMOs but products of LMOs. This was to eliminate possibility of regeneration though planting which was not intended when the imports were allowed in the country.

Though the country has some capacity in infrastructure, it is not adequate. Facilities that exist are mostly for MO detection (qualitative tests); Kenya needs enhanced capacity in risk assessment, Risk management, GMO detection (both qualitative and quantitative), capacity to carry out independent/confirmatory food feed safety assessment and personnel training.
Article 17 – Unintentional transboundary movements and emergency measures
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
99. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
105. Here you may provide further details on the implementation of Article 17 in your country
Biosafety Officers are placed at strategic entry /exit points of the country to ensure no unintentional or illegal introduction of LMOs. The Authority also conducts regular general market surveillance within the country to check whether there are unauthorized GMOs in the market.
Article 18 – Handling, transport, packaging and identification
106. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes, to some extent
Here you may provide further details
A draft Biosafety Regulation on Handling, Transport, packaging and Storage of genetically modified organisms is in place. It has already undergone stakeholder consultation awaiting approval and publication. As at present, NBA gives certain conditions in the approval document to ensure GMOs are handled, packed, stored or transported in accordance with best practices to avoid or minimize chances of escape into the environment.
107. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes, to some extent
108. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing types of documentation
110. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing types of documentation
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing types of documentation
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • Yes
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • None
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 10 or more
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
This question is relevant to indicator 2.3.2 of the Strategic Plan
  • Yes
120. How many laboratories in your country are certified for LMO detection?
This question is relevant to indicator 2.3.3 of the Strategic Plan
  • One or more
121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?
This question is relevant to indicator 2.3.4 of the Strategic Plan
  • One or more
122. Here you may provide further details on the implementation of Article 18 in your country:
A draft Biosafety Regulation on Handling, Transport, packaging and Storage of genetically modified organisms is in place. It has already undergone stakeholder consultation awaiting approval and publication.

Though capacity for testing GMOs exists in the country, it is not at the NBA which is the National Competent Authority on all matters of GMOs in Kenya. In some instances, the outsourced laboratories give contradictory results for the same samples making it difficult for NBA to confirm with 100% certainty where there are contradictions. This makes regulatory decisions difficult. There is need therefore that NBA acquires its own GMO testing laboratory with equipment and personnel. Due to budgetary constraints, NBA has not been able to procure PCR equipment and its accessories hence the continued use of outsourced testing services. The NBA is seeking for financial support towards the establishment of a fully functional molecular laboratory for GMO testing.

Customs officials are not trained on detection of GMOs; however, Biosafety inspectors are posted to 4 major entry points in the country. The country has about 10 entry points, hence there may be need to offer training to customs officials based at entry points where Biosafety Inspectors are not present.
Article 19 – Competent National Authorities and National Focal Points
123. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
124. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes, to some extent
125. Here you may provide further details on the implementation of Article 19 in your country
Kenya established the National Biosafety Authority as the competent national authority on matters of GMOs in the country. In the implementation of the Biosafety Act, NBA is required to consult 8 other Regulatory Agencies with various scopes on GMOs. NBA is the overall coordinating agency. There exists a coordinating mechanism (coordination structure) between the NBA and the 8 regulatory agencies but there is need for capacity building to fully understand the role of each agency and avoid duplication and overlaps of functions. 
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
126. Please provide an overview of the status of the mandatory information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
This question is relevant to indicator 3.1.5 of the Strategic Plan
a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information available but not in the BCH
d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information available and in the BCH
g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available and in the BCH
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available and in the BCH
l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available and in the BCH
m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information not available
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available but not in the BCH
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes, to some extent
Here you may provide further details
The NBA has a Department (Unit) for BCH operations. Capacity building so far has been on participation on online forums such as the FAO and CBD webnars
128. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, in some cases
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • Yes
Here you may provide further details
Posting of risk assessments and decisions on LMOs which are under research and currently with no code or unique identifier from OECD. Most of the risk assessments and decisions on contained use and field trials in Kenya are for crops such as sweet potato, cassava, sorghum, gypsophila etc which are not in the BCH Records for traits modified.
131. Is the information submitted by your country to the BCH complete and up-to date?
  • No
132. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • 5 or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • One or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National website
  • BCH Central Portal
  • Newspapers, Magazines, FAQs, brochures
135. Here you may provide further details on the implementation of Article 20 in your country
Posting of decisions directly to BCH is a challenge for experimental based LMOs. Kenya has not reached a stage of full commercialization of LMOs. There is need for capacity building to sensitize developers on registering their LMOs with the OECD and BCH. There is also need to sensitize regulatory agencies, policy makers and legislators on operations of the BCH as their awareness is still very low.

The posting of decisions in regard to question 127(f, j, k and l) is in regard to Kenya's National BCH which is linked to the international BCH through our website http://www.biosafetykenya.go.ke
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. Here you may provide further details on the implementation of Article 21 in your country
The Biosafety Act and its implementing Biosafety Regulations has provisions and circumstances where the applicant can request certain information be classified as confidential business information with the concurrence of the Authority. Certain information eg name of applicant, risk assessment report etc are clearly defined as non confidential information. There exists an operational SOP on how confidential information is handled once such an application is received by NBA.
Article 22 – Capacity-building
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • No
140. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
141. If you answered Yes to question 140, how were these resources made available?
  • Bilateral channels
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
143. If you answered Yes to question 142, how were these resources made available?
  • Bilateral channels
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
145. If you answered Yes to question 144, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 157.
  • Average
146. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Development of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
147. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
148. If you answered Yes to question 147, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Taking into account risks to human health
  • GMO containment with focus on GM mosquitos
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • Yes
150. If you answered Yes to question 149, has this information been submitted to the BCH?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • Yes
152. If you answered Yes to question 151, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • 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
  • Post release monitoring of genetically modified crops
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • Yes
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • No
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • 5 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
157. 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
Kenya has not benefited from UNEP GEF funds for Capacity building initiatives in the country. Kenya has a pool of 23 experts on biosafety. Training is required to equip them with skills on risk assessment on LMOs. Kenya also needs capacity to do quantitative tests on LMOs in addition to infrastructural capacity to carry out food safety tests.

There is also need for capacity building for other regulatory agencies on biosafety issues in the country. Kenya considers capacity building in the areas of social economic considerations and post release monitoring for GM crops very critical as we have already received two GMO applications (Bt maize and Bt cotton) for commercial release.
Article 23 – Public awareness and participation
158. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • Yes
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • Yes
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
National Biosafety Authority is mandated by the Biosafety Act to conduct public awareness on all matters of GMOs and biosafety in Kenya. The Authority has developed a communication strategy but we have challenges in implementation due to funding challenges. With a limited budget, the Authority with the assistance of other stakeholders has held an annual Biosafety Conference for the last 4 years (2012-2015), biosafety seminars and workshops.
162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?
This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan
  • Yes
163. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
This question is relevant to indicator 5.2.1 of the Strategic Plan
  • One or more
164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Yes
168. If you answered Yes to question 167, please indicate the modalities used to inform the public:
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
  • Newspaper
  • Forums
  • Mailing lists
  • Public hearings
  • Kenya Gazette Notice
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Newspaper
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
171. How many academic institutions in your country are offering biosafety education and training courses and programmes?
This question is relevant to indicator 2.7.1 of the Strategic Plan
  • 5 or more
172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:
This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan
  • None
173. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • Yes
175. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • Never
176. Here you may provide further details on the implementation of Article 23 in your country
Most of the learning institutions offer Biotechnology and Molecular biology programmes at degree level. Biosafety is taught as one of the subject but not at degree level. NBA has drafted a biosafety curriculum that it intends to offer as an academic programme in partnership with some selected Universities in the country.

Though the NBA has engaged the public in various national and county forums, public participation in the decision making process is only required (mandatory) while handling GMO applications for environmental release. To this effect, when NBA received an application for environmental release of MON 810 Bt maize in June 2015, the Authority put a public notice in two nationally circulated newspapers, Kenya Gazette Notice and NBA website seeking for public comments within 30 days. NBA additionally held a public hearing/gathering on the same application and received public views which are currently being analyzed.

There is also need for more capacity in offering biosafety education and training courses.
Article 24 – Non-Parties
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • Yes
179. Has your country ever exported LMOs to a non-Party?
  • Yes
180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes
181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?
  • No
183. Here you may provide further details on the implementation of Article 24 in your country:
The import and transit approvals were for food aid (corn and corn soy blend) from the USA in processed/milled form, so they were not LMOs. The country approved export and import of transgenic cassava material to and from USA (which is a non-party) but for research purposes. The imports were genetically modified cassava seedlings from USA while the exports were transgenic cassava leaves and stem tissue samples sent to USA for advanced laboratory analysis.
Article 25 – Illegal transboundary movements
184. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
186. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
If you replied Never to question 186 please go to question 191
  • Never
191. Here you may provide further details on the implementation of Article 25 in your country
The country had 2 cases of illegal importation of derived products of GMOs, not LMOs. They are currently being investigated and prosecuted in the country's judicial system.
Article 26 – Socio-economic considerations
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • Yes
193. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • No
194. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • 5 or more
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
Kenyan Biosafety Act requires mandatory consideration of socioeconomic impact assessment when an environmental release or placing in the market of a GMO is intended. Socioeconomic issues are being considered in the two applications for environmental release that the Authority is currently reviewing ie Bt maize and Bt cotton environmental release applications. Decision in the two applications is still pending.
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to some extent
197. Here you may provide further details on the implementation of Article 26 in your country
Kenya held a stakeholder forum on socioeconomic considerations. This was followed by another meeting with socioeconomic experts from Kenya, Burkina Faso, Ghana and Honduras to fine tune the broad areas identified in the 1st meeting.

Socioeconomic considerations is a mandatory requirement for environmental releases of GMOs but the Biosafety Act does not elaborate which issues shall be considered in the decision making process. Capacity building in this area is critical and urgent. Kenya has also had research exchanges with parties (Uganda, USA, and Switzerland).
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
199. If you answered No to question 198, is there any national process in place towards becoming a Party?
  • Yes
200. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
This question is relevant to indicator 2.4.1 of the Strategic Plan
  • Yes
201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan
  • Yes
202. 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
Though Kenya is not listed among the countries that have ratified the Supplementary Protocol, the country is in the process of ratifying this Protocol. Existing legal mechanisms are largely adequate to address any aggrieved parties. Selected Kenyan Lawyers have been trained on the provisions of the Liability and Redress Protocol in Biosafety matters.
Article 28 – Financial Mechanism and Resources
203. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • 100,000 USD or more
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • Yes
b) Enforcement system:
  • Yes
205. Has your country submitted all the previous due National Reports?
  • Yes
Other information
184. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.
Whereas there is substantial investments in product development by our development partners, the investments in enhancing functional regulatory systems are limited.Therefore, there is need for national systems and development partners to re-focus their priorities so that biosafety matters are also given a more prominent position in global funding

There is a challenge of posting information directly to the BCH as a regulator when the approved LMOs are still at research level and have not been allocated specific identity codes. This makes it appear that countries are not sharing information.
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report
It is desirable to have a provision for elaboration or explanation to each question rather than at the end of each Article.