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

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