Biosafety regulation in the Philippines: past present & future
Biosafety regulation in Kenya - past, present & future
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Transcript of Biosafety regulation in Kenya - past, present & future
Biosafety regulation in Kenya – past, present and future:
David WafulaPBS/IFPRI
Presentation Outline
The Evolving Biosafety System in Kenya
• Past 1995-2006
• Present 2007-2010
• Future- 2011 onwards
The Past 1995-2006INCEPTION
Establishing the Biosafety Regulatory System
• Kenya’s national biosafety system has evolved over the years in response to regulatory challenges and compliance with global requirements
• The National Council for Science and Technology (NCST) was established under the S&T Act 1980.
• NCST mandate-created a home for biosafety to be handled under the S&T Act of 1980
• NCST became the main Govt Agency responsible for biosafety
Establishing regulatory system• In 1995 NCST initiated a process of developing national
biosafety guidelines and regulations-finalized and issued in 1998.
• NBC established as the technical arm of the NCST to coordinate and ensure compliance with biosafety regulations
• Membership of NBC- broad based committee with representatives from key government agencies, the civil society, NGOs universities etc with rooster of advisory experts
• The guidelines made provision for the establishment of IBCs
The UNEP-GEF Project on NBFs
• Since 1998 Kenya benefited from UNEP-GEF support pilot project
• 18 countries supported to develop national biosafety frameworks with the following components
1. Biotechnology policy 2. Regulatory regime (legislation and regulations)3. A system for handling notifications or requests for
authorizations of GMOs4. A mechanism for monitoring and inspection5. Approaches for public information and participation
• A number of developments took place before the Biosafety Protocol was negotiated and adopted
• Kenya made history in 2000 by being the first country to sign the Cartagena Protocol on Biosafety and concluded the ratification process in 2003.
• The Protocol’s overriding objective is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of living modified organisms
Revising the Regulations
• The process of reviewing the guidelines issued in 1998 was done in 2003 to align them to the Biosafety Protocol
• Manual for monitoring and inspection • Guidelines for handling requests reviewed
• By early 2003 the guidelines had been applied in the GMO trial approvals of sweet potato, IRMA project, rinder pest vaccine and Bt cotton
Regulatory Agencies
• In the guidelines and regulations a number of regulatory agencies identified to support implementation.
• KEPHIS-all aspects of plant health and protection, inspection and approval of biosafety facilities and monitoring of trials
• DVS-animal health matters. Involved in testing of recombinant rinder pest vaccine
• KEBS-standard setting body for regulation of all foods including codex
• Public health department-health and safety aspects of food and feeds
Decision making procedure
• Applications to import or release GMOs (including applications for confined field trials) are submitted to the relevant Institutional Biosafety Committee (IBC)
• Applications reviewed and assessed for compliance with the guidelines before submission to the NBC.
• Applications reviewed by the NBC and/or a technical subcommittee of the NBC.
• A recommendation is made by the NBC and a decision made by NCST secretary and communicated to the applicant.
Initial Challenges that faced the NBC in Kenya
• Slow decision making speed- took 3 years for the 1st application- transgenic sweet potato to be approved (1997-2000)
• Learning process for NBC to study applications and source for more information
• The approval of Bt maize-IRMA project was shorter -18 months
• NBC secretariat had no operational budget from the Govt.
• It was not an independent and autonomous government agency
National Biotechnology Dev. Policy• In 2006 the Govt of Kenya approved a biotech policy • Pays attention to Kenya’s priorities in the safe
development and application of biotech• Links biotech to the country’s dev agenda in areas of
agricultural, industrial and environmental management etc
• The policy states that “The govt will adopt productivity-enhancing agricultural biotechnologies that can substantially reverse the fast deteriorating food security and nutrition, farm incomes, spur the agro-industry and reduce environmental degradation”
Limitations of the past institutional and legal regime
• Guidelines and regulations developed under the Science and Technology Act Cap. 250 lacked enforcement authority.
• Had no substantive provisions to move from CTFs, multi-location trials and environmental release
• No provisions for handling imports, exports and transit
• Lack of institutional permanency and autonomy
• Justification for stand-alone legislation that addresses the gaps
The Present 2007-2010TRANSITION PHASE
The Quest for new Legislation
• The process of drafting and debating the Biosafety Bill was a complex and protracted one. It started in 2002
• Characterized by polarized debates
• Passed through the life of three parliaments and two general elections
• Bill eventually passed in 2008 and enacted into law in 2009
Objectives, Scope and Provisions of the Biosafety Act 2009
• To facilitate responsible research and minimize risks that may be posed by GMOs
• To ensure an adequate level of protection for the safe transfer, handling and use of GMOs
• To establish a transparent, science-based and predictable process for reviewing and making decisions on GMOs
Scope and provisions
• The covers applications to introduce GMOs for contained use, environmental release, placing on the market, import and export and transit.
• 8-regulatory agencies designated in ensuring compliance.
• Risk assessment and management measures• Penalties and environmental restoration
orders spelt out
Scope and provisions
• Made provision for formation of NBA
– Chairperson-Eminent scientists
– Permanent secretaries- Ministries of S&T, finance, agriculture
– Directors of- NEMA, KEBS, KEPHIS, DVS, Secretary NCST, Chief Public Health Officer
– Representatives of- consumers, farmers and the private sector
– CEO- appointed by the board (secretary)
Functions of NBA• Key functions of the authority embrace overall
supervision and control of the development, transfer, handling and use of genetically modified organisms for research or commercial purposes
• Specifically– Consider and determine applications– Advise the Govt on legislative issues on GMOs– Promote awareness and public education on
biosafety issues– Establish and maintain a biosafety clearing house
Implementing Regulations
• Contained use activities• Environmental release• Importation and exportation• Transit• Handling, packaging, transporting and
labeling of GMOs• Forms to be used for applications for
approvals and schedule of fees
Features of the present regime
• Adequate legal authority-shortcomings of the S&T Act addressed by the Biosafety Act. 2009
• Institutional autonomy and independence-NBC replaced by NBA
• Key components of NBF visible although the system is yet handle applications for environmental release
Lessons• Establishing new legislation is time-
consuming and expensive
• It requires a supportive political environment
• A new law is not self implementing-the transition process poses many challenges
• Capacity building for implementation fundamental
Capacity Building in Biosafety• UNEP-GEF- support on enabling biosafety systems• Kenya Agricultural Biotechnology Platform (BTA)-initial support for
biosafety capacity building • BIO-EARN- funded by SIDA (2000-2009)• BiosafeTrain-capacity building for biosafety and ecological impact
assessment of transgenic plants in East Africa (funded by DANIDA)
• ABNE and ICGEB• PBS-2007-2010 Project on building a functional biosafety system– Legal review of the Biosafety Bill & implementing regulations– Coordination structure– NBC secretariat– Training courses for regulators, lawyers, MoA and Public Health
PBS Kenya Implementing PartnersPBS Kenya Implementing Partners
NBA
MoA
Regulatory Agencies
ISAAA
KEBS NEMAPublic HealthKEPHIS DVS PCPB
PBS/IFPRI
PBS Kenya Advisory Group
Committee
KIPI
KWS
Awareness creation
• An important aspect in any biosafety regulatory regime
– BioAWARE launched in 2008 under MoA– OFAB started in 2006– NGOs- ABSF, A-harvest, ISAAA, Kenya
biodiversity coalition actively engaged– Universities- UoN project on outreach
• Media training for science reporters
The Future of the Biosafety System• NBA work with regulatory agencies to
develop guidelines on commercial release
– Application, review and risk assessment process
– Food safety and environmental safety considerations
• Define socio-economic considerations
• Technology stewardship issues
• Revision of the national biotechnology policy
The Future of the Biosafety System• Focused and targeted capacity building for
implementation of the Biosafety Act.
• Development of the national biotechnology strategy
• Post-market release assessments
• Ensure that decisions by NBA and regulatory agencies are enforced
• Need to draft a detailed framework on post-market inspection and monitoring
INTERNATIONAL FOOD POLICY RESEARCH INSTITUTE
Critical stages in a functional biosafety system
A functional system ensure adequate safety but allow the country to test potential promising products and deploy to end-users
Science, Technology and Innovation is rapidly bringing new challenges. Science-based biosafety regulatory systems fundamental
THANK YOU FOR LISTENING!!!