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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