Kenya is advancing positively towards implementation of the International Agreement on Cartagena Protocol on Biosafety

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1 Kenya is advancing positively towards implementation of the International Agreement on Cartagena Protocol on Biosafety Report by Willy Kiprotich Tonui, PhD, RBP, EBS Chief Executive Officer National Biosafety Authority and Focal Point for Cartagena Protocol on Biosafety in Kenya The National Biosafety Authority (NBA) being the focal point for Cartagena Protocol on Biosafety (CPB) in Kenya has been spearheading our Country s preparations and participation during the Eighth meeting of the Parties (MOP 8) to the Cartagena Protocol to CPB to be held in Cancun, Mexico, 4 17 December The opening of the meeting will take place on Sunday, 4 December 2016, concurrently with the opening of the thirteenth meeting of the Conference of the Parties to the Convention (COP 13) and the second meeting of the Conference of the Parties serving as the meeting of the Parties to the Nagoya Protocol on Access and Benefit-sharing (COP- MOP 2). The Cartagena Protocol on Biosafety is a supplementary agreement to the Convention on Biological Diversity. Its objective is to contribute to ensuring the safe transfer, handling and use of living modified organisms that may have adverse effects on conservation and sustainable use of biological diversity, taking also into account risks to human health. The Protocol was adopted on 29 January 2000 in Montreal, Canada and entered into force on 11 September To date, 167 countries and the European Union have ratified or acceded to it. The Protocol is named after the Colombian city of Cartagena where the final round of its negotiations was launched. The governing body of the Protocol, known as the Conference of the Parties to Convention on Biological Diversity serving as meeting of the Parties to the Protocol (or COP-MOP, in short), has held seven earlier meetings in Kuala Lumpur in February 2004; in Montreal in June 2005; in Curitiba, in March 2006; in Bonn in May 2008; in Nagoya, in October 2010; in Hyderabad, in October 2012; and in October, 2011 at the Alpensia Convention Center in Pyeongchang, Republic of Korea. During these meetings Page 1 of 5

2 delegates, include representatives from Government, civil society and industry represent Kenya. Kenya is a signatory to the Cartagena Protocol on Biosafety having signed in the year 2000 followed by ratification in The Government of Kenya approved the National Biotechnology Policy in 2006 which provided policy direction in the safe applications of Biotechnology in the country. The policy proposed the enactment of the relevant Biosafety laws and establishment of the National Biosafety Authority (NBA) as a way of domesticating the provisions of the Cartagena Protocol. In 2008, the Kenyan Parliament passed the Biosafety Bill. It was subsequently enacted by the President in February 2009 to become what is referred as the Biosafety Act No. 2 of The NBA is the designated National Competent Authority for Kenya and the National Focal Point for the Cartagena Protocol on Biosafety. The overall mandate of NBA is to exercise general supervision and control over development, transfer, handling and use of genetically modified organisms (GMOs) so as to ensure safety of human and animal health and provide adequate protection of the environment. This includes all activities of GMO for food, feed, industrial, research or any other use. To achieve this mandate, the Authority has developed the following biosafety regulations which are now fully operational. These include Biosafety (Contained use) Regulations, 2011 with the objective to guide research on GMOs at laboratory, green houses and confined field trials; The Biosafety (Environmental Release) Regulations, 2011 whose objective is to guide all activities of environmental or commercial release and placing on the market (sale) of GMOs; The Biosafety (Import, Export and Transit) Regulations, 2011 whose objective is to guide on the requirements for traders and any person who may be interested in importation, exportation or transboundary movement of GMOs; The Biosafety (Labelling) Regulations, 2012 with the objective to provide information to consumers on the GM status of food/feed and to help traceability of the products when they are in the market. Among the most significant outcomes from the recent COP-MOP 7 meeting was a decision inviting governments and other stakeholders to use the Guidance on Risk Assessment of Living Modified Organisms developed by an expert group that was established by governing body of the Protocol in actual cases of risk assessment and as a tool for capacity-building activities in risk assessment. In the same decision, the Parties to the Cartagena Protocol also decided, to extend the Page 2 of 5

3 Open-ended Online Expert Forum (Online Forum) and the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management with revised terms of reference and expanded composition. During its meeting in 2016, the AHTEG on Risk Assessment and Risk Management developed an outline containing specific considerations regarding the risk assessment of LMOs developed through current and near-future applications of synthetic biology. The main issues to consider on this item during COP 8 are for Parties to consider whether to support adoption of the guidance document in its current form or to reject it and whether to extend the term of the online forum and Ad Hoc Technical Group (AHTEG) so as to develop Risk Assessment Guidance Document on LMO fish, LMOs developed through Synthetic Biology and any other document deemed necessary. Another very important agenda to be discussed during COP 8 will be Item 15 on the contentious issue on Socio-economic considerations. At its seventh meeting, the meeting of the Parties to the Cartagena Protocol, in decision BS-VII/13, decided to extend the AHTEG on Socioeconomic Considerations, and mandated it to work, in a stepwise approach amongst them to the further development of conceptual clarity on socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity. During COP 8, the Executive Secretary will issue a note containing a description of the intersessional activities related to socio-economic considerations as well as the outcome of the online discussion of the AHTEG on socio-economic considerations, for consideration by the Parties. It is expected that socioeconomic considerations will be discussed extensively and a decision to reconvene a group of experts to further develop clarity on this issue and to develop an outline for guidance on this subject is adopted. Parties will also discuss progress made towards adoption of Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress under Item 16. The Executive Secretary will issue an update on the status of the Supplementary Protocol and related activities undertaken, including a prospect for potential capacity-building measures. It is important to note that though Kenya has not ratified the Supplementary protocol the country has implemented this requirement by adopting Restoration and Cessation orders in Part VI of the Biosafety Act. Page 3 of 5

4 Public awareness, education and participation will be discussed under Item 17 during COP 8. Under this item, the meeting of the Parties to the Cartagena Protocol will consider the status of implementation of the programme of work and, as appropriate, decide on its future need and/or necessary revisions to its elements and measures for improving its implementation and effectiveness in supporting Parties. As a result of public awareness, education and participation NBA has this year approved two applications for environmental release of Bt Maize and Bt Cotton for the purposes of National Performance Trials (NPTS). NBA has also approved a number of GMO applications at laboratory, greenhouse and confined field trials which include eleven (12) applications approved for contained use research (Laboratory, growth chambers and greenhouse) and 24 applications approved for confined field trials. Twenty eight (28) applications for import and transit of milled GM products have also been approved by NBA. As part of providing a forum for scientists, policy makers, civil society, farmers, NGOs, private sector players and other stakeholders to objectively debate the issues on Biosafety, NBA hosted the Fifth Annual Biosafety Conference in August. The Conference brought together diverse stakeholders in the various fields of policy, biotechnology, biosafety and biosecurity, research, agriculture, public and animal health, environment, engineering, industry, academia and the media fraternity under one Conference theme Strengthening global, regional, national collaboration, partnerships and capacity towards meeting international obligations in Biosafety. There exists a National Strategic Plan which guides the development of Biosafety in Kenya. To fulfil her role in coordinating all activities involving genetically modified organisms (GMOs), NBA declared 2016 to be the Year of Excellence in Biosafety Regulations. As a Centre of Excellence, the Authority endeavours to strengthen global, regional, national collaboration, partnerships and capacity by supporting the adoption and compliance with the Cartagena protocol and monitoring the implementation of its obligations under the protocol and to report on measures taken to implement the protocol. In conclusion, Kenya as a country is moving forward steadily in meeting her obligations to the CBP by aligning national laws and Page 4 of 5

5 recently submitted the third national report and other reports made available through the Biosafety Clearing-House. Kenyan delegation during the Preparatory Meeting for the COP-MOB 8 in to be held in December in Mexico Page 5 of 5