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Hennie Groenewald (PhD)
Department:Science and TechnologyREPUBLIC OF SOUTH AFRICA
African Seed Trade Association, Cairo Egypt, 28 Feb 2018
biotech context
CONTEXT: AGRICULTURE & AFRICAN DEVELOPMENT
Key messages
• African countries should increase investment in R&D and relevant innovation in agriculture.
• Increased agricultural production and food security will come through technological innovationsand education.
• African governments should create a positive investment climate for private sector participationin agricultural R&D.
From: Regulation of Agricultural GM Technology in Africa, ASSAf 2012
Biotechnology in Africa
%
90%
95%
100%
US$ 2.1 billionsince 1998
or
US$ 237 millionper annum
value
From: www.biosafety.org.za & Brookes & Barfoot, 2017
GENERAL RELEASE vs FIELD TRIAL PERMITS 1999-2014
From: www.biosafety.org.za
Nigeria
Burkina-Faso
Cameroon
Ghana
Sudan
Egypt
Ethiopia
Tanzania
KenyaUganda
Malawi
Mozambique
Zimbabwe
Swaziland
South Africa
Why have GM crops been slow to take hold in Africa?
From: www.biosafety.org.za
Challenges to the Adoption of GM Crops
1. Policy uncertainty and the indecisiveness of African leaders.
2. Passiveness of African scientists and science associations.
3. Inadequate investment in scientific research and promotion of innovation.
DEVELOPMENT AND ADOPTION OF GM CROPS IN AFRICA
Key messages
• Only 3 African countries have approved the commercial production of GM crops and few more have approved field trials.
• Policymakers should avoid reliance on perceptions of risks and rather deploy expert risk assessment and scientific advicein decision-making.
• Robust and credible GM policies and regulatory instruments require strong scientific advisory systems to ensure science-based advice and decision making. Professional science bodies should engage actively in the debate on GMOs.
From: Regulation of Agricultural GM Technology in Africa, ASSAf 2012
Markets?
Safety?Benefits?
Ownership?
Acceptance?
Trust?
Sustainable?
Economic
Health Environment
Socio-political
sustainable
safe
viable
Su
stai
nab
le G
MO
s
© B
iosafe
ty S
A
the future
From: https://ccafs.cgiar.org
From: https://ccafs.cgiar.org
www.farmingfirst.org
www.farmingfirst.org
Sustainable intensification in African agriculture
https://ag4impact.org
https://ag4impact.org
marker-assisted
selection
tissue culture
recombinant
DNA
induced genetic
variation
Biotechnology
induced genetic variation
• Non-browning mushrooms*
• Herbicide tolerant canola*
• Waxy corn
• Disease resistant
tomatoes, rice, wheat,
bananas, etc.
• Slow growing cabbage
• Vitamin enriched oranges
• Drought tolerant maize,
wheat, rice, etc.
Genome Editing R&D
• Hornless cattle
• Disease & pest resistant
pigs, goats, chickens, etc.
• Female only chickens
• Double muscled pigs &
cattle
• Hypoallergenic chickens
• Gene therapy in humans*24
• Scientists Discover Secret of How to Triple Number of Sorghum Grains
• Ghana CSIR Affirms Safety of GM Crops
• Study Shows How Plants Use 'Baits' to Trap Pathogens
• Transgenerational CRISPR-Cas9 Induces Multiplex Gene Editing in
Wheat
• WEMA Gives Hope for Farmers Battling Armyworm in Kenya
28 February 2108
26
New opportunities, new challenges
1. Trigger - product vs process
2. Threshold
3. Managing risk vs managing risk perceptions
Key issues
Risk vs legal (political) discussion
Findings
1. NBTs hold great potential, in particular for developing biotech
innovation systems.
2. Only a few countries have formalised regulation.
3. Genome modified organisms the principle source of risk, this
product should therefore be the trigger and subject of regulation.
4. South Africa’s GMO Act sufficient & threshold for regulation is
genetic variation beyond that which may occur naturally.
5. Consider a succinct consultation process to determine if product
is regulated.
6. Likely regulatory outcomes of suggested framework aligns well
with current consensus discussions.
Bre
ed
ing
nu
ll se
gre
ga
nts
i.e
. re
ve
rse
-&
acce
lera
ted
bre
ed
ing
SDN-1
SDN-2
SDN-3
ODM
Also referred to as genome editing and actual techniques include ZFNs, MNs, TALENs & CRISPR-Cas9
Genetic impact / classification
site directed nucleases (SDN)
Techniques used to introduce genetic variation
cisgenesis
RNAi
Application
Conventional crops & livestock, GM-crops & -livestock, rDNA medicines, gene therapy, biopharming, gene drives, etc.
Rd
DM
“standard” GM-technology
hybrids, polyploidy, mutants, etc.
“New breeding techniques” (NBTs)
Trans-grafting
intragenesis
somatic hybridisation
synthetic biology
Increasing scope of induced genetic variation
agro-infiltration / transient gene expression
ploidy manipulation
mutagenesis
transgenesis
Ind
uce
d
gen
etic
var
iati
on
product 2e.g. containing a transgene
process 1e.g. CRISPR-Cas
product 1e.g. containing a single nucleotide substitution
a.
Product 3e.g. containing a singlenucleotide insertionprocess 2
e.g. CRISPR-Cas
process 1e.g. mutagenesis
b.
c.end product applicationprocess
e.g. breedinggenetic modification
NBTssynthetic biology
e.g. organismvarietyGMO
mutant
e.g. medicinefood
industrial chemicalgene drive
RISK ANALYSIS
Product vs. process trigger
natural genetic variation
≡ natural biosafety risk
natural risk threshold
≡ regulatory threshold
genetic variation > natural
≡ biosafety risk > natural
regula
ted
no
t re
gula
ted Small, targeted & untargeted
insertions or deletions based on
no-homologous end joining
(NHEJ) & homology-directed
repair (HDR); large genomic
deletions; cisgenesis; epigenetic
modifications; null segregants
Insertion of heterologous,
functional gene sequences,
including genes and/or regulatory
sequences (transgenesis);
intragenesis
[figure 7.1, p79]
Regulatory threshold
[novel combination of DNA]
Risk >
natural
YesNo
NoYesNo
Were any new heritable genetic
material/mutations directly
introduced into the final product?
Does the NBT use a transgene
temporarily?
Has any heterologous genetic
material remained behind?
Product not regulated under
the GMO Act.
Product regulated under the
GMO Act
Were any heterologous
genetic material introduced?
No Yes NoYes
Could the genetic variation
have originated naturally?
Yes
Risk ≤natural
Notification procedure
Registrar: GMO Act
“Oversight”(consultation)
Regulation
32Pro
po
sed
fra
mew
ork
• Defining “genetic variation beyond that which may also
occur naturally” → i.e. defining an acceptable
threshold. [≡ “novel combination” in other systems]
• International alignment [& leadership].
• [Arguing] Alignment with Cartagena Protocol on
Biosafety.
CHALLENGES
33
“…any living modified organism resulting from modern biotechnology that may…”
“Living modified organism” means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology;
Terms - techniques, genetic impact and use.
Need to better distinguish between…
1. Variability
2. Risk analysis vs. risk perception
3. Value (particularly in public innovation systems)
Better communicate…
Increasing uncertainty and confusion (especially in unexperienced
systems)
And avoid…
IN CONCLUSION
mainstreaming agri biotech in Africa
ACCEPTANCE
is key
• Trust precedes
knowledge
• Develop products
that benefit end
consumer directly
Dr Hennie Groenewald hennie@biosafety.org.za www.biosafety.org.za
Thank you!
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