Department of Science and Technology GMO Amendment Bill (B34-2005)

1. Department of Science and TechnologyGMO Amendment Bill (B34-2005) Ben Durham Director: Biotechnology Department of Science & Technology ben.durham@dst.gov.za www.dst.gov.za

2. BackgroundSouth Africa’s National R&D Strategy The three operational objectives of the strategy are: Achieving mastery of technological change in our economy and society(Innovation) Investment in South Africa’s Science, Engineering and Technology Base (Human Capital and Transformation) Strengthening the government S&T system and private sector participation (Alignment and Delivery)

3. South Africa’s National Biotechnology Strategy Minister Science and Technology National Advisory Council on Innovation Other govt departments Biotech Advisory Committee Department of Science and Technology Biotechnology Unit Biotech Stakeholders Biotech Instruments

4. DST & Biotechnology Unit Innovation support & commercialization Public Issues Frontier Programmes Technology Platforms • BRIC’s • PlantBio • Innov. Fund • Incubators • NBN (Bioinf) • Funct.Genomics • Microarray • Fermentation BAC PUB Ethics Research Councils SAAVI Industry Universities Start-ups Grants BIOTECH OUTCOMES South Africa’s National Biotechnology Strategy

5. South Africa’s National Biotechnology Strategy Developing the Innovation Chain • Biotechnology • Full range, but some emphasis on 3rd generation • Regional • Regional socio-economic, environmental and academic advantages • Innovation • System A: science to technology – robust platforms • System B: technology to product / market – enhanced commercialization • System C: embed technology/product in an enterprise – increase incubation • Centres • Aggregator/broker/supplier for networks & services that support systems A,B,C

6. South Africa’s National Biotechnology Strategy • National Bioinformatics Network • Develop Bioinformatics capacity in South Africa • Provide Bioinformatics network infrastructure • Developing a Functional Genomics platform Public Understanding of Biotechnology • Promote a fact-based understanding of biotechnology • Facilitate engagement on biotechnology

7. South Africa’s National Biotechnology Strategy BRIC scope: • Human & Animal health – diagnostics, h-t screening; vaccines; bioprospecting & gene mining • Industrial Biotech - industrial enzymes; pharmaceutical intermediates; Agroprocessing; bioleaching; • Plant biotech – Biosafety platform & transgenic crops; plant breeding & IV propagation; gene mining • IP management; business skills; mentorships; • Cluster development / network facilitation • Capacity development Cross cutting

8. South Africa’s National Biotechnology Strategy

9. South Africa’s National Biotechnology Strategy Growth in R&D Expenditure of Biotechnology related disciplines in SA – 2002-2004 SA 2004: Performers of Biotechnology and related fields according to funds spent

10. 41% of national core companies • 40% of national research groups Tertiary Education Institutes - Science Councils - Private Companies (Core) - • 37% of national core companies • 34% of national research groups DST eGoliBio Biotech Survey 2003 South Africa’s National Biotechnology Strategy • Key biotech statistics for SA in 2003: • 47 core biotech companies • 59 non-core biotech-capable companies • 622 biotech (and biotech-related) projects • At least 3,500 employed in biotech sector • >R 368m in annual revenues in biotech sector • Since 1992, 2 new core biotech companies have been set up annually. Click To Add Text

11. South Africa’s Biotechnology Potential • South Africa has: • Biosafety Legislation (GMO Act of 1997; National Environmental Management Act of 2004, etc) • 22 Universities • 7 Science Councils • An unrivalled biodiversity • Excellent infrastructure • A leadership role in Africa

12. Biosafety Legislation: GMO Act 1997 National alignment: SAC advice; Sustainabledevelopment; Labour; Trade; Socio-economics; Transformation; Ethics →DECISION ExecutiveCouncil • Case-by-case, science-based Risk Assessment • Human health: toxicity; pathogenicity; allergenicity; digestibility; nutrition; unexpected products, gene stability, ethics. • Environment: impact on:living organisms; Biodiversity; gene flow; weediness; air, soil, water; gene stability, ethics. • → RECOMMENDATION Scientific Advisory Committee Application Completeness of applications; regulatory compliance; risk management → IMPLEMENTION Registrar

13. GMO Act 1997 + amendments “To provide for measures to promote the responsible development, production, use and application of GMO’s, to provide for an adequate level of protection during all activities [], to lay down the necessary requirements and criteria for scientifically based risk assessments, environmental impact assessments, socio-economic considerations and risk management measures []..” 5.(1) The council shall - (a) determine whether that applicant must, in addition to his or her application, submit an assessment of the impact on the environment and socio-economic considerations of such activities. (c) in considering an application have regard to the following factors: (i) Scientifically based risk assessments; and (ii) proposed risk management measures. (f) Advise the Minister […] on measures to minimise any adverse impact on the conservation and sustainable use of biological diversity [].

14. DST Workshop – Science-Based Risk Assessment and triggers for Environmental Impact Assessments. In the light of the rapidly developing biotechnologies, to provide science-based guidelines on risk assessment processes for new or forthcoming GMO’s. • Upcoming GM event categories: • Stacked gene crops • Biopharming • Indigenous vs non-indigenous GM crops • GM microbes • GM animals • Biosafety technology developments: chloroplast transformation, sterility techniques – nuclear, cytoplasmic etc, etc. • Criteria for social impacts

15. South Africa’s National Biotechnology Strategy Thank you! Ben Durham Director: Biotechnology Department of Science & Technology ben.durham@dst.gov.za www.dst.gov.za