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Biosafety Framework in Kenya

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    The Biosafety framework inKenya

    ro . or ng on . goy

    Director, Technical Services

    National Biosafety Authority

    Presentation During the First Biosafety Conference,Nairobi, KENYA

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    Biosafety Act, 2009

    Makes provision for the establishment of alegal framework for the safe handling, use andtransfer of genetically modified organisms

    Sets up the National Biosafety Authority as the

    National focal point of all Biosafety matters in

    Kenya

    NBA to exercise general supervision andcontrol over dealings in GMO with a view toensuring safety to human and animal healthand protection of the environment

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    Mandate of National Biosafety Authority

    Consider and determine applications forapproval for the safe transfer, handlingand use of GMOs;

    Co-ordinate research and monitorac v es on a wor as per e c ;

    Strengthen national technical capacitiesand capabilities for biosafety;

    Develop regulations to operationalize theBiosafety Act;

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    Vision

    A World Class Biosafety Agency

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    Mission

    To ensure and assure safe development,,

    modified organisms in Kenya

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    Regulatory Agencies

    The NBA implements mandate through variousregulatory agencies namely:

    Kenya Plant Health Inspectorate Service (KEPHIS)

    Directorate of Veterinary Services (DVS)

    Department of Public Health (DPH)

    National Environmental Management Authority(NEMA)

    Kenya Wildlife Service (KWS)

    Kenya Industrial Property Institute (KIPI)

    Pesticide Control Products Board (PCPB)

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    Role of Regulatory Agencies

    Monitor approved GMO activity to ensure

    compliance with conditions of approval

    Inform Authority of any significant new scientific

    pose biosafety risks not previously known

    Inform Authority of unintentional or unapproved

    introduction of a GMO into the environment andpropose mitigation measures

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    Handling Applications

    Any person wishing to undertake any activitiesusing GMOs can only do so with the approval

    of the NBA

    Activities envisaged under the Act include- Researc - conta ne use, con ne use

    introduction into the environment/ Placing on the

    market

    Import, transit, export

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    Prepare and submit application to NBAStart

    Is dossiercomplete?Communicateto Applicant

    Yes

    complete?

    Not complete

    Communicate to Relevant Regulatory Agency(s)

    and selected experts for review

    9

    Communicate to

    ApplicantApproved?

    Yes

    complete?

    Not complete

    Approval with/ without relevant conditions

    The end

    Communicate to

    Applicant and Relevant

    Regulatory agency(s)

    Monitoring for adherence to approval conditions and

    provisions of the Biosafety Law

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    Risk Assessment

    Risk assessment objective identify and evaluatethe potential adverse effects of GMO to humanhealth and environment

    General principles:

    i)Scientifically sound and transparent manner

    not imply a a particular level of risk, absence ofrisk or an acceptable risk

    iii) Risk of GMO must be considered in thecontext of non-GMO

    iv) Risk assessment should be carried out on acase-by-case basis.

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    Decision Making

    Based on Risk assessment report from reviewers,submitted by applicant and available information

    The Authority then prepares a decisiondocument

    The decision document will contain-

    A summary o t e app ication inc u ing t edetails of the applicant, the genes involved, thepurposes of the intended use

    The risk assessment The decision

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    OTHER PROVISIONS OF THE ACT

    Composition of the Board of Management

    Review and Appeal Mechanism

    Inspection and monitoring

    Restoration and Cessation orders

    Offences and Penalties

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    BIOSAFETY REGULATIONS

    The Law provided for gazzetment ofregulations that would be important for theimplementation of the Biosafety Act 2009;

    To date 4 regulations have been gazetted:Regulations for;

    Contained Use

    Environmental Release

    Import, Export and Transit

    Regulations for Labeling (2012)

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    Biosafety (Contained Use) Regulations

    Context and Scope These regulations cover activities involving

    GMOs under containment and confinement

    They are typically applied during research on , ,

    Objective (Art. 3)

    The objective of this Regulation is to ensure

    that potential adverse effects of genetically

    modified organism are addressed to protect

    human health and the environment when

    conducting contained use.

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    Contained Use: Requirements

    A person shall not conduct any activity involving

    GMOs without written approval from the

    Authority(Biosafety Act, 2009, Art. 18)

    without the written approval of the Authority

    (Art. 7. (1)

    Such activity must be carried out within or incollaboration with a research institution

    The research institution carrying out such activity

    must establish Institutional Biosafety committee

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    Biosafety (Envir. Release) Regulations

    Context and Scope These regulations cover activities involving

    release of GMOs into environment; placing on

    market

    Objective (Art. 3)

    The objective of these Regulations is to ensure

    that potential adverse effects of genetically

    modified organisms are addressed to protect

    human health and the environment when

    conducting environmental release.

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    Environmental Release: Requirements

    A person shall not conduct any activity involving

    GMOs without written approval from the

    Authority(Biosafety Act, 2009, Art. 18)

    release or place on market a GMO without the

    written approval of the Authority.(Art. 5(1); 6 (1)

    An application for environmental release/placingon market shall be made to the Authority (in a

    prescribed manner with KShs 850,000 as fees)

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    FLOW CHART-ENVIRONMENTAL RELEASE

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    Biosafety (Import, Export & Transit)

    RegulationsContext and Scope

    These regulations cover activities involvingimportation into, exportation out of and movement ofGMOs through Kenya

    Could touch on aspects of release or placing on market

    Objective (Art. 3)

    The objective of these Regulations is to ensure safemovement of genetically modified organisms into andout of Kenya while protecting human health and theenvironment

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    Import, Export & Transit: Requirements

    A person shall not conduct any activity involving

    GMOs without written approval from the

    Authority(Biosafety Act, 2009, Art. 18)

    ,

    GMO shall apply for and obtain written approval

    from the Authority (Arts. 4(1); 5(1) & 6 (1)

    A person transiting shall ensure GMO is packagedand transported as per Kenyan Laws

    Transit require prior approval by the receiving

    country

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    LABELING REGULATIONS, 2012

    Objective:

    To ensure that consummers are aware that

    food/feed or product is GMO for informed

    To facilitate traceability of GMO products

    towards enforcement of appropriate

    management measures

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    Provisions of the labelling regulation

    Application: foods consisting of GMO orderived from GMO

    Exemptions: Where GMO is bellow 1%

    threshold level; Highly refined foods devoid of, ve, n en e r

    consumption and sold from food food

    premises or vendors

    Labelling requirement

    Monitoring inspection and compliance

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    APPLICATIONS SINCE AUGUST, 2010

    CFT LAB/GREE

    N HOUSE

    TRANSIT/I

    MPORT

    APPROVALS 5 5 27

    TOTAL 7 7 28

    Target crops in CFT: cotton maize,

    sorghum, cassava

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    Monitoring and Evaluation

    Quarterly reports expected from approvedprojects

    Monitoring In consultation with regulatory

    agencies

    Monitor compliance with the act

    Undertake inspections

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    HIGHLIGHTS OF NBA STRATEGIC PLAN

    STRATEGIC PLAN 2011- 2015 FOR BIOSAFETY

    THEMATIC AREAS:

    * Capacity building

    * Public awareness and artici ation

    * Biosafety information management system

    * Collaboration and partnerships

    *Coordination for effective implementation of

    biosafety regulations

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    THANK YOU


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