Biosafety Framework in Kenya

The Biosafety framework in Kenya
Prof. Dorington O. Ogoyi

Director, Technical Services National Biosafety Authority
Presentation During the First Biosafety Conference, Nairobi, KENYA
Biosafety Act, 2009

Makes provision for the establishment of a legal framework for the safe handling, use and transfer 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 and control over dealings in GMO with a view to ensuring safety to human and animal health and protection of the environment
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;
Vision
A World Class Biosafety Agency
Mission
To ensure and assure safe development, transfer, handling and use of genetically modified organisms in Kenya
The NBA implements mandate through various regulatory agencies namely:

Kenya Plant Health Inspectorate Service (KEPHIS) Directorate of Veterinary Services (DVS) Department of Public Health (DPH) Kenya Bureau of Standards (KEBS) National Environmental Management Authority (NEMA) Kenya Wildlife Service (KWS) Kenya Industrial Property Institute (KIPI) Pesticide Control Products Board (PCPB)
Regulatory Agencies
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
Handling Applications
Any person wishing to undertake any activities using GMOs can only do so with the approval of the NBA Activities envisaged under the Act include Research- contained use, confined use introduction into the environment/ Placing on the market Import, transit, export
Start
Communicate to Applicant
Prepare and submit application to NBA

Not complete
Is dossier complete?
Yes complete? Communicate to Relevant 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 Approvalcomplete? with/ without relevant conditions
Monitoring for adherence to approval conditions and provisions of the Biosafety Law
The end9
Risk Assessment
Risk assessment objective identify and evaluate the potential adverse effects of GMO to human health and environment General principles: i)Scientifically sound and transparent manner ii) Lack of scientific knowledge or consensus does not imply a a particular level of risk, absence of risk or an acceptable risk iii) Risk of GMO must be considered in the context of non-GMO iv) Risk assessment should be carried out on a case-by-case basis.
Decision Making
Based on Risk assessment report from reviewers, submitted by applicant and available information The Authority then prepares a decision document The decision document will contain A summary of the application including the details of the applicant, the genes involved, the purposes of the intended use The risk assessment The decision
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
BIOSAFETY REGULATIONS
The Law provided for gazzetment of regulations that would be important for the implementation 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)
Biosafety (Contained Use) Regulations

Context and Scope These regulations cover activities involving GMOs under containment and confinement They are typically applied during research on GMOs (LAB, Green house, Screen house CFT) 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.
Contained Use: Requirements

A person shall not conduct any activity involving GMOs without written approval from the Authority (Biosafety Act, 2009, Art. 18)
A person shall not undertake contained use without the written approval of the Authority (Art. 7. (1) Such activity must be carried out within or in collaboration with a research institution The research institution carrying out such activity must establish Institutional Biosafety committee
Biosafety (Envir. Release) Regulations

Context and Scope These regulations cover activities involving release of GMOs into environment; placing on market Typically apply during commercialization 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.
Environmental Release: Requirements

A person shall not make an environmental release or place on market a GMO without the written approval of the Authority.(Art. 5(1); 6 (1) An application for environmental release/placing on market shall be made to the Authority (in a prescribed manner with KShs 850,000 as fees)
FLOW CHART-ENVIRONMENTAL RELEASE
Biosafety (Import, Export & Transit) Regulations

Context and Scope
These regulations cover activities involving importation into, exportation out of and movement of GMOs through Kenya Could touch on aspects of release or placing on market in which case Regulations on Release apply
Objective (Art. 3)
The objective of these Regulations is to ensure safe movement of genetically modified organisms into and out of Kenya while protecting human health and the environment
Import, Export & Transit: Requirements

A person wishing to import, export or transit a 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 packaged and transported as per Kenyan Laws Transit require prior approval by the receiving country
LABELING REGULATIONS, 2012
Objective: To ensure that consummers are aware that food/feed or product is GMO for informed choice To facilitate traceability of GMO products towards enforcement of appropriate management measures
Provisions of the labelling regulation Application: foods consisting of GMO or derived from GMO Exemptions: Where GMO is bellow 1% threshold level; Highly refined foods devoid of GMO, food additive, food intended for consumption and sold from food food premises or vendors Labelling requirement Monitoring inspection and compliance
APPLICATIONS SINCE AUGUST, 2010

CFT
APPROVALS 5
PENDING TOTAL
2 7
LAB/GREE N HOUSE 5 2 7
TRANSIT/I MPORT 27 1 28
Target crops in CFT: cotton maize, sorghum, cassava
Monitoring and Evaluation

Quarterly reports expected from approved projects Monitoring In consultation with regulatory agencies Empowerment of Biosafety inspectors
Monitor compliance with the act Undertake inspections
HIGHLIGHTS OF NBA STRATEGIC PLAN

STRATEGIC PLAN 2011- 2015 FOR BIOSAFETY THEMATIC AREAS: * Capacity building * Public awareness and participation * Biosafety information management system * Collaboration and partnerships *Coordination for effective implementation of biosafety regulations
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The Biosafety framework in Kenya

Prof. Dorington O. Ogoyi

Presentation During the First Biosafety Conference, Nairobi, KENYA

Biosafety Act, 2009

Mandate of National Biosafety Authority

A World Class Biosafety Agency

The NBA implements mandate through various regulatory agencies namely:

Role of Regulatory Agencies

Prepare and submit application to NBA

Communicate to Applicant and Relevant Regulatory agency(s)

Yes Approvalcomplete? with/ without relevant conditions

OTHER PROVISIONS OF THE ACT

Biosafety (Contained Use) Regulations

Contained Use: Requirements

Biosafety (Envir. Release) Regulations

Environmental Release: Requirements

FLOW CHART-ENVIRONMENTAL RELEASE

Biosafety (Import, Export & Transit) Regulations

Import, Export & Transit: Requirements

LABELING REGULATIONS, 2012

APPLICATIONS SINCE AUGUST, 2010

Target crops in CFT: cotton maize, sorghum, cassava

Monitoring and Evaluation

HIGHLIGHTS OF NBA STRATEGIC PLAN

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