Hennie Groenewald (PhD) - AFSTAafsta.org/reload/wp-content/uploads/2018/03/Hennie-Induced-geneti… · Hennie Groenewald (PhD) Department: Science and Technology REPUBLIC OF SOUTH

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 [email protected] www.biosafety.org.za

Thank you!