THE BIOTECHNOLOGY POLICY AND
BIOSAFETY MECHANISMS FOR GMOs
IN KENYA
George M. Siboe,
School of Biological Sciences
University of Nairobi
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• EXPERTS SOUND ALERT OVER
RISING CASES OF DIABETETES IN
KENYA!
– More than 1.2 million people suffering from
diabetes (Charity Ngilu, 30th june 2007)
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I.
INTRODUCTION
Purpose of this presentation
•
To outline Kenya’s policy on biotechnology
with specific reference to GMOs.
INTRODUCTION
2.
To outline the biosafety framework against
which decisions are made about the activities
involving GMOs in Kenya.
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The biosafety Framework for GMOs:
What is biotechnology?
• Biosafety refers maximizing on benefits of biotechnology as we ensure
protection to human health and the environment from possible adverse
effects of the products.
•
The Genesis:
•
The 1975 Asilomar `Declaration’: Scientists at an international meeting
expressed concern over the potential effect of modern biotechnology and
designed strict restrictions on the use of recombination (r DNA) techniques.
– Consequently, International conventions and protocols came into being to
implement and enforce the scientists’ recommendation on rDNA
techniques (Gene technology). Example (Gartagena protocol).
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The Instruments of the National Biosafety
Regulatory Framework
1. The proposed Biosafety Act, 2007
2. The National biotechnology Policy, 2006.
– Guidelines on handling requests involving
GMOs.
– Guidelines on inspection and monitoring of
GMOs.
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II.
KENYA’S POLICY ON BIOTECHNOLOGY
• In principle and Practice, Kenya has
adopted Gene technology for purpose of:
– Improving the quality of human welfare.
– Maximizing productivity in Agriculture and industry
– Protecting the environment.
• BUT ensuring that the application of the
technology and the use of products are
safe to human health and the environment
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The Policy ---• Institutionalizes scientific risk assessment and
management as a basis for approval of GMOs
for research field trail and commercialization.
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The Policy ---•
Provides clear principles on following priority areas:-
1. Agricultural biotech: - to adopt productivity enhancing biotechnology.
2. Education: - to strengthen science education because biotech is a
knowledge–driven and research intensive industry.
3. Bioresources: - To use biotechnology interaction to exploit the rich
biodiversity and traditional knowledge associated with it for industrial
product development.
4. Environmental Biotechnology:
• To use appropriate biotechnology to address:
(i) Environmental pollution.
(ii) Eco- restoration for degraded habitants.
(iii) Aforestation and reforestation
(iv) Bioremediation of waste
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The Policy ----
5. Medical Biotechnology
• To use the crème technology for development of
–
–
–
–
–
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Vaccines
Vitamins
Hormones
Gene therapy
Diagnostic kits
Development of traditional herbal medicines into
superior industrial therapeutic products.
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The Policy ----
6. Industry and trade:
• The focus is to use Gene technology for value addition to
primary commodities e.g. conversion of local
bioresources into:
– Biofuels
– Biofertilizers
– Pharmaceuticals
– Food processing products
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The Policy ---•
The policy provides guidance to key issues that
need attention in order for the country to gain a
strategic position in modern biotechnology
platform, and these include:1. Capacity building and mobilization of
resources:
– Human resource development
– Infrastructure, facilities and equipment
– Prioritization and co-ordination of research and
development
– Financial and business support
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The Policy ---• Public protection and support:
1) Intellectual property rights
• Government fund to support the filing of patents.
2) Protection of traditional knowledge and resources
• Emphasizes royalties, patenting, access to information and
benefit sharing of profits from biotech.
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The Policy ---3) Products from GMOs:• All products containing engineered genes or
derived from GMOs must meet requirements of
the laws of Kenya governing:– Biosafety (The proposed biosafety Act 2007)
– Environment (EMCA)
– Sanitary and phytosanitary standards (P/Health, KEPHIS,
DVS & KEBS)
– Food and pharmaceutical standards (P/Health)
• Release of GMOs only after careful and
comprehensive Risk Assessment and ethical
considerations.
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The Policy ---4) Public education and awareness :
– To create balanced public awareness on biotech issues and
investment opportunities.
– Ensure access to information on development of biotech held by
public authorities
– Ensure public participation in decision making process.
5) Ethical issues
• Kenya will not allow the use of science to propagate unethical
practices e.g. socially negative trends in biotechnology
development like:
–
–
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Human cloning
Use of stem cells obtained unethically
Introduction, use, or release into Kenya of any GMOs that have
terminator gene sequences
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III.
Biosafety legal instruments and
process for the regulation of GMOs
Why do we need a separate legislation to
regulate GMOs?
1. To provide for measures to promote the
responsible development, production and use
of GMOs.
– E.g. The proposed Biosafety Act 2007 demands
that Approvals of activities involving GMOs for
containment use, introduction into the environment,
placing on the market, or in transit must be
preceded by a Science-based RISK ASSESSMENT
of any effects on human health and the environment.
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Why separate legislation-------2) Ensures that more information is made
public e.g. Assessment reports on the
suitability of GMOs for marketing.
3) Facilitates efficient and transparent
decision-making process on GMOs for
Kenya to benefit from biotechnology
investment.
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The Procedure for Handling requests involving
GMOs in Kenya
Application to NBC (NBA) secretariat
IBC
Relevant experts screen for completeness
Secretariat acknowledges Receipt
(May request for additional information)
Risk Assessment by Experts
Report to NBA
NBA decision to allow or not to allow.
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The procedure for the analysis of risk
from GMOs
Applicant lodges application with NBC:
Technical Screening:
Hazard identification
Science-based Risk assessment
Risk Management Plan
Risk management - Giving effect to Plan:
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Technical Screening:
Risk assessment
We Analyze and evaluate the risks
by:
Assessing the probability of harm
from human or environmental
exposure to each hazard
Identifying possible consequences to
health or the environment from
exposure to each hazard
Assessing the level of certainty of the
estimates
Identifying risks that are
consequential and which are not of
any consequence
Risk management - Giving effect to Plan:
Pre- conditions:
Training, prepare site, upgrade facilities etc
During & after project/release:
Monitoring, usually by the applicant
Surveillance/inspection by Regulatory
Agent for compliance with legislation and
conditions (Each ensuring that the project or
product is not causing significant/unanticipated
impacts on health or the environment during
project & until impacts are no longer likely.)
Hazard identification
Identification of types and sources of
hazard to human health or environmental?
Ensuring that all hazards are identified
Risk Management Plan
We consider:
Available options to remove or mitigate
each of the risks of consequence
Whether the level of risk that remains is
acceptable
Whether the steps required to remove or
mitigate the risk are acceptable and/or
feasible
Then:
Decline to allow activity as too risky; OR
Set out risk management requirements
for allowing application to proceed
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DON’T WORRY, BE HAPPY-----.
THANK YOU
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