Labelling Requirements and Label Claims for Dietary Supplements and Recommend...
AU NEPAD Addis Meeting March 2023-Kassahun.pptx
1. Policy Options for Regularization of Stacked
Trait Biotech Crops in Ethiopia
Kassahun Tesfaye (PhD), Messay Emana, and Hailu Dadi (PhD)
Director General
Bio and Emerging Technology Institute
Consultative Workshop organized by
the African Union Development Agency-NEPAD (AUDA-NEPAD)
7-8 March 2023; Capital Hotel,
Addis Ababa, Ethiopia.
2. Content
MinT and National Innovation System
STI Policy
Innovation, Research and Technology Landscape
Ethiopian Biotechnology Sector
Gene Stacking Technology
Gene Stacking Technology for Ethiopia
3. Introduction
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The Ethiopian government committed to use STI to enhance productivity and efficiency of
various economic sector.
The Ministry of Innovation and Technology( MinT) is mandated to lead, Coordinate &
Manage Technological, Research and Innovation matters at national level;
Ethiopia STI policy has been revised, mainly to focused on Job creation, wealth creation and
GDP contributions in national economic development;
As part of this effort, there are various initiatives i.e STI Roadmaps, Digital Ethiopia,
Science Museum, Research Support, Biotech Research program, Science café, Talent Institute
etc.
Moreover, Ethiopia has develop sectorial roadmaps in 20 sectors depending on national
priority area.
4. Overview of MINT
• One of the priority areas for home grown economy reform for
the next 10 years
Accountable Institutions are
• Bio & Emerging Technology Institute (Research)
• Ethiopian Space & Geospatial Institute (Research)
• Ethiopian Technology Authority (Regulatory)
• Ethiopian Intellectual Property Agency (Regulatory)
5. Mandates (MinT)
• National Policy initiative
• National Innovation Development
• National Research coordination and support
• ICT and Digital Transformation
• Regulation and system establishment
• Organize innovation and technology data base, compile
information, set national standards for information
management
6. Three Pillars -Focus Areas
• Innovation
• Technology
• Digitalization
• Bioeconomy (to be considered for future)
7. Work towards
• National capacity building of innovation, research and
technology
• Build Incubation center, Talent School..
• Building national digital economy
• Build infrastructure, creating enabling environment
• Strengthen Research/ technology –industry linkage to increase
and improve productivity and competitiveness
• Provide Research grant and Innovation grant
• Creating enabling national STI system and regulatory system
• Startup regulation, start up grant…
8. National Innovation System of Ethiopia
Execution
Innovation
Support &
Research
System
The Base
The Prime Minister
S&T Council
S&T Related
Ministries
MinT
Financial
Support
TVET
RI
National
Quality
System
People and Culture
Quality General Education
Universities
S&T
University
NationaI
IP
Tech
Parks,Incubat
ion Centre
Other
Impl
SMME
TOP
LEADERSHIP
9. The FDRE STI Policy
The STIP of the FDRE
was issued in 2012
replacing the National
Science and Technology
Policy that was adopted in
1993.
This policy primarily
comprises general
directions and major
implementation strategies
identified upon series of
consultative discussions
held with stakeholders.
STI Policy Revision 2022
10. Science, Technology and Innovation (STI) Policy and Strategy
• Basic philosophy( cross-sectoral )
• Out put oriented
• Job creation
• Wealth creation
• GDP contributions
11. 11
Innovation, Research and Technology land
escape
Innovators
and start up
support
National
Research
support
Technology
transfer
Innovation, Research and Technology landscape
17. Focus areas
Biotechnology has received strong governmental support and commitment to promote R&D.
Biotechnology in the government’s priority area as part of the 10 year plan
Ministerial Steering Committee, Establish Biotech National Taskforce (6 Experts) in 2014
Developed Biotechnology Roadmap for 10 years
1. Ethiopian Biotech Research & Development Roadmap
2. Ethiopian Human Resource Development Roadmap
3. Ethiopian Agricultural Biotechnology Roadmap
4. Ethiopian Industrial Biotechnology Roadmap
5. Ethiopian Environmental Biotechnology Roadmap
6. Ethiopian Health Biotechnology Roadmap
• Based on this, The Government established the Ethiopian Biotechnology Council and Institute-EBTi (June
2016) with Ministerial Council Regulation No. 388/2016 and then Ethiopian Bio and Emerging technology
Institute was renamed in 2021 by Proclamation No. 1263/2021
18. Biotechnology National Plan and Education in Ethiopia
National Plan
1. National Biotechnology Curriculum review and
development
2. Biotechnology research and laboratory infrastructure
plan
3. Biotechnology investment and marketing strategy
4. Guideline for biotechnology regulation framework in
Ethiopia
5. Biotechnology Research Program for 10 years
Education
As oldest and largest university AAU was
the first to start training in biotechnology
13 University Undergraduate
6 University MSc
PhD- AAU,UG,AASTU and ASTU
19. Biosafety Laws in Ethiopia
1. THE CONTENT OF AN
APPLICATION FOR
UNDERTAKING DELIBERATE
RELEASE OF MODIFIED
ORGANISMS (የአከባቢ ልቀት)
Ethiopia biosafety law was
issued in 2009, No.
655/2009
And the Amended
biosafety law in 2015, No.
896/2015
2. RISK ASSESSMENT PARAMETERS FOR
MODIFIED ORGANISMS (የጠንቅ ግመገማ)
5. MANAGEMENT OF RISKS FROM
ANY TRANSACTION INVOLVING
MODIFIED ORGANISMS (በዝውውር
ላይ ለሚከሰት ጠንቅ)
4. DETERMINE THE
REQUIREMENTS FOR TRANSPORT
AND STORAGE OF MODIFIED
ORGANISMS (ክምችትና
ትራንስፖረት)
3. ESTABLISH MAJOR CONTENTS OF AN
APPLICATION FOR SPECIAL PERMIT TO ENGAGE
IN THE TRANSATIONS OF MODIFIED
ORGANISMS FOR RESEARCH OR TEACHING (ለዩ
ፍቃድ)
6. ESTABLISH THE INSTITUTIONAL BIOSAFETY
COMMITTEE
Draft Genome editing guideline
20. Gene Stacking Technology
Continuous improvement of crops by incorporating new genes in plant varieties is extremely important for ensuring
agricultural productivity in optimal and adverse climactic conditions.
Often multiple genes are required to manage a single trait that may need to be deployed over a period of time; for
example, multiple genes of insect resistance or herbicide tolerance are needed to manage evolving resistance against
chemicals used to suppress pests and weeds in the field (Keweshan et al., 2015; Que et al., 2010; Storer et al., 2012).
Gene Stacking is a type of gene cloning that refers to the process of combining two or more genes of interest in to a
single plant.
The emerging combined traits from this process are called Stack traits
Stacking of traits is accomplished through two methods:-
1) by conventional plant breeding, where parents with single GM events are crossed to produce progeny that
contain two or more GM events, commonly referred to as stacked trait products (also known as “breeding
stacks”), or
2) by using molecular methods, where two or more traits are simultaneously or sequentially introduced into a
host plant. The difference between the two stacking methods is that stacked trait products produced via
conventional breeding do not contain a new event(s) that has not been assessed and approved by regulatory
authorities
21. Gene Stacking Technology
Stack offers a broader agronomic enhancements that allow farmer to meet their needs under complex farming
condition
Have better chance of over coming the numerous of problems in the field such as insect, disease, weed and
environmental stress
Boost up and simplifies pest management for biotech crops as demonstrated by multiple insect resistance based on Bt
gene technology
22. Regulatory Options for Gene Stacking Technology
Regulatory principles and procedures for approval and release of biotech stacks differ globally.
In countries like the USA and Canada, no separate or additional regulatory approval is
necessary for commercializing hybrid stacks that are products of crossing a number of already
approved biotech lines.
In Japan and European Union (EU) countries to the contrary, stacks are considered new events,
even if individual events have market approval, and must pass through a separate regulatory
approval process, including risk assessment of their safety, similar to mono-trait biotech events.
Risk assessment is focused on the identification of additional risks that could arise from the
combined genes.
Following the most practical and less costy regulatory approach is more recommendable in
Ethiopian Context
Separate directive
With case by case evaluation
23. Gene Stacking Technology for Ethiopia
Agricultural production in Ethiopia is characterized by subsistence orientation, low productivity, low level of
technology and inputs, lack of infrastructures and market institutions, and extremely vulnerable to rainfall
variability.
Productivity performance in the agriculture sector is critical to improvement in overall economic well-being
in Ethiopia.
Low availability of improved or hybrid seed, lack of seed multiplication capacity, low profitability and
efficiency of fertilizer, lack of irrigation development, lack of transport infrastructure, inaccessibility of
market and prevalence of land degradation, unfertile soil, overgrazing, deforestation and desertification
are among the constraints to agricultural productivity during last period.
Climate change, Drought, flood, disease, insect and weed are the major challenge of the agriculture
sector in Ethiopia.
To overcome the agriculture sector challenges , a technology having multiple purpose is needed and
Gene stack technologies are one of the technology that will solve problems in the sector.
In Ethiopian case; Maize is the first crop with stacked and potato ????
24. Recommendations
Crop production is constrained with multiple stress
Multi trait stacked Biotech crop approach is the way forward to address this
challenge
Less expensive way of regulatory system should be considered for Ethiopian
context
Capacity building and infrastructure establishment for stacked trait
Regulatory experience sharing and visit, training should be a way to enhance
the capacity of our regulatory
25. Thank you!
Synergistic move in STI is the key to achieve the
vision of becoming a middle income economy by
2025!
Editor's Notes
Innovation is the implementation of creative inspiration. The National
Innovation Initiative (NII) defines innovation as “the inter-section of invention and
insight, leading to the creative of social and economic value” Innovation is “value” – the
creation of value adding value to customer’s satisfaction- “delighting the customers”.
Innovation is the basis of all competition advantages, the means of anticipating and
meeting customer’s needs and the method of utilization of technology.