Biosafety regulatory framework in Kenya: challenges and approaches Willy K. Tonui, PhD, RBP, EBS CEO, Kenyan National Biosafety Authority 4 th Annual South Asia Biosafety Conference 19-21 Sept, 2016
Introduction to Biosafety in Kenya Kenya signed the Cartagena Protocol on Biosafety in 2000 and ratified it in 2003. National Biotechnology Development Policy Published in 2006. Biosafety Bill signed into law on 12th February 2009 giving rise to Biosafety Act No. 2 of 2009.
Process towards Kenya s Biosafety Regulatory Framework 2000 2006 2009
Biosafety Act, 2009 Sets up the National Biosafety Authority as the National focal point of all Biosafety matters in Kenya Makes provision for the establishment of a legal framework for the safe handling, use and transfer of genetically modified organisms NBA to exercise general supervision and control over dealings in GMO with a view to ensuring safety to human and animal health and protection of the environment 9/21/2016 4
Objects of the Act To facilitate responsible research into and minimize the risks that may be posed by GMOs To ensure an adequate level of protection for safe transfer, handling and use of GMOs that may have an adverse effect on the health of the people and the environment To establish a transparent, science-based and predictable process for reviewing and making decisions on transfer, handling and use of GMOs 9/21/2016 5
Mandate of National Biosafety Authority Consider and determine applications for approval for the safe transfer, handling and use of GMOs Co-ordinate research and monitor activities on all GMO work as per the Act Strengthen national technical capacities and capabilities for biosafety Develop regulations to operationalize the Biosafety Act 9/21/2016 6
Mandate of National Biosafety Authority Establish and maintain a Biosafety Clearing House (BCH) mechanism web based information sharing of national database that is linked to the international BCH; Promote public awareness on biosafety and biotechnology; Enforce the provisions of the Biosafety Act; Provide advisory services on matters of biosafety 9/21/2016 7
Governance The NBA is managed by a Board of Management comprising of: A Chairperson who must be an eminent scientist appointed by the Minister for the time being responsible for Science and Technology CEOs (or their Appointed Alternates) from six (6) Government agencies whose mandates relates to biosafety issues Six (6) other persons appointed by the Minister, 3 of whom shall be experts in biological, environmental and social sciences, the others as follows; One shall represent the interests of consumers, One shall represent the interests of farmers One shall represent the interests of the biotechnology industry. Representative of the Permanent Secretary (PS) - Ministry responsible for Science and Technology Representative of the PS - Ministry of Finance Representative of the PS - Ministry of Agriculture CEO of the National Council for Science and Technology (NCST) CEO of the NBA appointed by the Board who is also the Secretary to the Board
Third Board October 2- to date
Vision A World Class Biosafety Agency 9/21/2016 10
Mission To ensure and assure safe development, transfer, handling and use of genetically modified organisms in Kenya 9/21/2016 11
Biosafety Regulations The Law provided for gazettement of regulations that for the implementation of the Biosafety Act 2009; To date 4 regulations have been gazetted: Regulations for; Contained Use GMOs Environmental Release of GMOs Import, Export and Transit of GMOs Labeling (2012) of GMO containing material (e.g. foods and feeds) 9/21/2016 12
Other Provisions Review and appeal mechanism Restoration and cessation orders Suspension/Revocation of approval Handling of New Information Contingency measures Miscellaneous (Register of Decisions, BCH, CBI) Offences, Schedules Public awareness and participation Monitoring 9/21/2016 13
Enforcement of Biosafety Legislation In enforcing the Biosafety law, the NBA collaborates with a number of regulatory agencies as specified in the Biosafety Act 9/21/2016 14
Regulatory Agencies (RAs) 1. Department of Public Health DPH KIPI 8. Kenya Industrial Property Institute DVS PCPB 7. Pest Control Products Board 2. Directorate of Veterinary Services KEBS KWS 6. Kenya Wildlife Service 3. Kenya Bureau of Standards 4. Kenya Plant Health Inspectorate Services KEPHIS NEMA 5. National Environment Management Authority
Role of Regulatory Agencies Monitor approved GMO activity to ensure compliance with conditions of approval Inform Authority of any significant new scientific information indicating that an approved activity pose biosafety risks not previously known Inform Authority of unintentional or unapproved introduction of a GMO into the environment and propose mitigation measures 9/21/2016 16
Progress on GM trials 9/21/2016 17
Start Prepare and submit application to NBA Communicate to Applicant Not complete Is dossier complete? Yes Communicate to Relevant complete? Regulatory Agency(s) and selected experts for review Submit review report to NBA Communicate to Applicant Not complete Approved? Communicate to Applicant and Relevant Regulatory agency(s) Yes Approval complete? with/ without relevant conditions Monitoring for adherence to approval conditions and provisions of the Biosafety Law The end 18
GM Crops Research and Field Trials in Kenya RIFT VALLEY: TRANS NZOIA KITALE Improved Maize for African Soils (IMAS) CENTRAL KENYA: KIRINYAGA - MWEA Bt Cotton (completed) WESTERN: KAKAMEGA Virus Resistant Sweetpotato CENTRAL KENYA: MURANGA THIKA Virus Resistant Cassava (VIRCA) WESTERN: BUSIA ALUPE Virus Resistant Cassava (VIRCA) BioCassava Plus (BC+) RIFT VALLEY: NAIVASHA -Purple Gypsophilla flower COAST: KILIFI MTWAPA Virus Resistant Cassava (VIRCA) EASTERN: MAKUENI KIBOKO Water Efficient Maize for Africa (WEMA) African Biofortified Sorghum (ABS)
Approved research activities on GMOs in Kenya since 2010 Year Contained Use Confined Field Trials 2010 1 1 0 2011 7 3 0 2012 3 2 0 2013 0 2 0 2014 8 2 0 2015 1 2 0 2016 2 0 2 TOTAL 22 12 2 Environmental release (for NPT) NB: Environmental release - Bt. Maize and Bt. Cotton (limited to National Performance Trials) 9/21/2016 20
Requirement of Public Consultation during Environmental Release One of the public forum involving public participation for an environmental release application
Current approaches towards a fully functional regulatory system 9/21/2016 22
Strategic objectives Guided by Kenya s Vision 2013 and NBA Strategic Plans (2016-2020). The following strategic objectives have been identified towards establishment of a functional Biosafety system in Kenya; Enhancement of Biosafety regulatory framework Capacity building for a functional biosafety regulatory framework Biosafety Advocacy initiatives Development of Policies, Guidelines and SOPs 9/21/2016 23
Capacity building Training of IBCs in research institutes and universities conducting research on GMOs Holding of Annual National Biosafety Conferences Training of policy makers Foreign delegations Hosting of workshops with international partners e.g CERA, ILSI Deputy President H.E. William Somoei Ruto addressing participants of the 4th Annual National Biosafety Conference held from August 11-14, 2015 at Kenya School of Monetary Studies (KSMS), Nairobi. 9/21/2016 24
5 th Annual Biosafety Conference Held 15 th 18 th August 2016 in Nairobi 9/21/2016 25
Partnerships with CERA/ILSI GM Food/Feed Safety Assessment Workshop7-8 August 2014 Food Allergy and Safety Assessment Workshop,11-12 August 2014: 9/21/2016 26
Biosafety Advocacy initiatives Also done during the Annual biosafety conferences and workshops Biosafety advocacy targeting the regulatory agencies and key ministry and county officials Hosting Annual Breakfast meetings for CEOs of Regulatory agencies 9/21/2016 27
Sensitization of MPs and Senators MPS Visit to KALRO lab Meeting with Senators
Sensitization of Parliamentary Committee of Agriculture Hon Kareke Mbiuki, Viice Chair Agriculture Parliamentary making a presentation at OFAB session
Workshop for Members of Parliament Hon Florence Mutua visiting KU lab 6 th August 2015 Hon Sabina Chege Chair Science Committee making her remarks at KU
Partner s Collaborative Efforts ISAAA, BioAWare, OFAB, ABSF, KuBICO, AATF and many others
Regulatory challenges 9/21/2016 32
Regulatory Challenges and Opportunities The ban on GMO food import remains in force since 2012 Limited Awareness creation initiatives on Biosafety Lack of state-of art laboratories for GMO detection and testing of samples Limited pool of biosafety experts for review of applications Submission of incomplete dossiers by some applicants Limited Budgetary allocation 9/21/2016 33
Regional Partnerships and Collaborations 9/21/2016 34
Regional partnerships NBA supports the Association of National Biosafety Agencies in Africa (ANBAA) a network of African Biosafety Agencies in Africa Mission to Collaborate, share and enhance safe, and Responsible Work with biotechnology in Africa. 9/21/2016 35
Official Launch of ANBAA March 9, 2016
Countries involved Burkina Faso Cameroon Ethiopia Ghana Kenya Malawi Mali Mozambique Namibia Nigeria Senegal Swaziland South Africa Sudan Tanzania Togo Uganda Zambia Zimbabwe
Hurdles in sharing data and information between countries to be reduced by promoting Regional and Bilateral Agreements between countries. A critical mass of NBA s with the political will to move forward in adopting plant biotechnology. Development of Regional AU Policies and harmonized regulatory system a possibility. ANBAA Training, exchange programmes and Conferences to be initiated. Strengthening partnerships between AANBA and countries with an extensive history of working with the technology. The FAO initiative involving Argentina, Ethiopia, and Kenya as an initiative is a good example.
1 st AFRICAN BIOSAFETY LEADERSHIP SUMMIT AUGUST 15-16, 2016, NAIROBI, KENYA Theme: Leadership in the Face of Challenging regulatory environments
Summit Objectives Among the specific objectives of the Summit were: To identify the regulatory needs of African countries with the purpose of ensuring adoption international agreements. To enhance collaboration, networking and implement programmes in biosafety and implementation of international agreements among African countries. To seek International cooperation towards reducing the risk of biological threats by collaborating with governments to develop regulations that is consistent with international guidelines, norms and requirements. 9/21/2016 40
1 st AFRICAN BIOSAFETY LEADERSHIP SUMMIT AUGUST 15-16, 2016, NAIROBI, KENYA Theme: Leadership in the Face of Challenging regulatory environments 9/21/2016 41
Technical Networks to support Expertise ANBAA provide expertise in the following areas: Lawyers Network Food Safety Resource Network Socioeconomic Network Environmental Biosafety Network Laboratory Detection Network Science Communications Network
Communiqué The ANBAA membership commits itself to: Serve as the African voice on biosafety issues and advocate for adoption of internationally agreed best practices in the continent; Enhance the Pan-African collaboration, networking and joint implementation of programmes in biosafety and support compliance to international agreements in Africa; Reduce biosafety risks by collaborating with governments and other institutions to explore mechanisms and policies that are consistent with international guidelines, norms and requirements; 9/21/2016 43
Communiqué -2 Encourage participation of other agencies in Africa to establish a critical mass of NBAs with determination to facilitate safe use of modern biotechnology; Reduce hurdles in sharing data and information on biotechnology and biosafety between countries; Initiate regional and local training, exchange and mentorship programmes; and Work towards development of regional policies and common approaches to regulatory systems acceptable to most countries in the region to reduce trade barriers, facilitate transboundary movements of LMOs and strengthen expertise across Africa. 9/21/2016 44
Thank You For more information: Website: www.biosafetykenya.go.ke E-mail: info@biosafetykenya.go.ke ceo@biosafetykenya.go.ke