Presented by Jasper Rees, Agricultural Research Council, South Africa, at the Workshop on Animal Genetic Research for Africa (Biosciences for Farming in Africa), Nairobi, 10-11 September 2015

1. ASSAf Panel: Regulatory Implications of
New Genetic Engineering Technologies
Jasper Rees
Agricultural Research Council, South Africa
Animal Genetic Research for Africa (Biosciences for
Farming in Africa), Nairobi, 10-11 September 2015

2. Why address new GE technologies now?
Application
stage
No. of Countries
Commercial
production
3
Confined field
testing
7
Contained
research
At least 14
Developing
capacity for
research and
development
At least 27

3. GM Crop R&D in Africa
Application stage No. of Countries Country Names
Commercial
production
3 Burkina Faso; Egypt; South Africa
Confined field
testing
7
Burkina Faso; Egypt; Kenya; South
Africa; Uganda; Nigeria; Malawi
Contained
research
At least 14
Burkina Faso; Cameroon; Egypt;
Ghana; Kenya; Mali; Mauritius;
Namibia; Nigeria; South Africa;
Tanzania; Tunisia; Uganda; Zimbabwe;
Malawi
Developing
capacity for
research and
development
At least 27
South Africa; Burkina Faso; Egypt;
Kenya; Morocco; Senegal; Tanzania;
Uganda; Zambia; Zimbabwe; Benin;
Cameroon; Ghana; Malawi; Mali;
Mauritius; Namibia; Niger; Nigeria;
Tunisia; Algeria; Botswana; Ethiopia;
Madagascar; Rwanda, Burundi, Sudan

4. Why an panel now?
• DAFF and DEA represented at workshop to
launch JRC report in 2011
• 2012 DST aware of JRC report
• Presentation on NPBT to GMO Exec Council -
2013
• DST plans process to assess NBPT
• 2014 – DST Commissions AASAf study to
ensure independent process
• 2015 – ASSAf Panel convenes and starts work

5. Applying scientific thinking
in the service of society
Regulatory Implications of New Genetic
Engineering Technologies:
Consensus Study Panel
2015-16
5

6. Applying scientific thinking
in the service of society
Brief Overview on Consensus Studies

7. Consensus Studies
Purpose:
• To provide credible, independent and unbiased evidence-
based policy recommendations that are based on
consensus reached through study panel deliberations.
Processes – broadly divided into five categories:
1. Development of the the Study Brief (Proposal)
2. Selection of the Study Panel & Council Approval
3. Panel Meetings, Information Gathering & Drafting of the
Report
4. Peer-Review Process, Finalization & Approval of the Report
5. Release & Dissemination of the Report

8. Consensus Studies
Key Requirements:
• Well-defined set of key questions or problems;
• Knowledgeable and balanced panel of experts;
• Opportunities for the panel to gather information in
public and to deliberate in private in order to reach
consensus;
• Unbiased evidence-based analysis by the panel - free
from the influence of study sponsors or others with a
vested interest in the outcome of the study findings;
• Production of a consensus output expressed as findings,
conclusions & recommendations in publicly released
statements, reports or advisory documents.

9. Consensus Studies
Panel meetings:
• All study panel deliberations are confidential – it enables
the panel to develop draft findings and
recommendations free from outside influence;
• Summaries of particular discussions may, at the
discretion of the Chair, be prepared and released for
public comment and/or the gathering of further
information and evidence;
• Certain activities of Study Panels may take the form of
public conferences, workshops, debates and hearings
(from which the Study Panel will then confidentially draw
its conclusions).

10. Consensus Studies
Information Gathering Processes:
• The study panel typically gathers information through:
 reviewing of existing scientific literature,
 investigations conducted by the panel members and staff,
 commissioning/contracting experts/researchers,
 meetings/workshops open to the public & announced in
advance, and
 submission of information by outside parties.
• Sponsors can be invited to present to the panel in order to
discuss their expectations and they are also asked to provide as
much information relevant to the study as possible.

11. Consensus Studies
Drafting of the Report:
• Panellists often draft the different chapters or portions of the
report but the final report is a collective product of the panel;
 Authorship is for the whole panel & final report becomes ASSAf
property.
• The Consensus Study Panels take full responsibility for the draft
reports prepared by them;
• The Study Panel Chair (or, where absolutely essential, the Chair’s
nominee) is the only spokesperson until the public release of the
report after ASSAf Council approval;
• Thereafter, the ASSAf President becomes the spokesperson;
• The Panel issues a single final ASSAf Report that is in line with its
approved study brief.

12. Mandate and ToR
• 1) Evaluate the risk/benefit implications and ethics of all relevant
new technologies (generally, but also with specific reference to their
ability to sustain the diversity of agricultural crops, their ability to
improve the agronomy, production and/or value of the crops).
• 2) Determine – with justification - which new technologies should
fall under the GMO Act and which do not.
• 3) Outline a framework which can be used to assess the
applicability of future technologies to the existing GMO Act &
regulations.
• 4) Assess the appropriateness of South African biosafety regulatory
framework for biosafety risk evaluation and management of all
relevant new technologies.
• 5) Where appropriate, recommend modifications/revisions and/or
additions to the existing regulations, individually or collectively, for
the new technologies.

13. Who is who?
• Dr Hennie Groenwald – CEO Biosafety SA
• Prof Gustav Bouwer – Wits University – Chair of GMO
EC
• Dr Kingstone Maisingaidze – ARC – Lead maize breeder
and ARC PI in WEME and IMAS
• Dr Jasper Rees – ARC – GE RIS
• Prof Inqbal Parker – Director of ICGEB Cape Town
• Mr Kulani Machaba – SANSOR representative and
Pioneer Regulatory Officer – withdrew in first meeting
• Two more members to be added by ASSAf

14. Target technologies – including:
• Cis-genesis and intragenesis
• MegaNucleases (ZFN, TALEN, CRISPR)
• Oligo directed mutagenesis
• RNA dependent DNA methylation and epigenesis
• Grafting onto GM rootstocks
• Reverse Breeding
• Agroinfiltration
• Synthetic Biology
• Rapid Breeding technologies
• Gene Drives

15. Possible outcomes
• Leave the GM Act and Regulations as they are.
• Recommend minor changes to the Regulations
to cover these technologies
• Recommend changes to exclude some or all of
these technologies from regulation
• Recommend major review of GMO Act to
address review and regulation of novel traits
• Recommend ending all regulation…

16. Dr Jasper Rees
ReesJ@arc.agric.za

17. New Traits being released
• Innate™ potato, a food staple with lower
levels of acrylamide, a potential carcinogen,
and less wastage due to bruising
• reduced lignin alfalfa event KK179 (HarvXtra™)
with higher digestibility and yield
• White maize, suger beet, brinjal…