Ben Durham

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Department of Science and TechnologyGMO
Amendment Bill (B34-2005)

• Ben Durham
• Director Biotechnology
• Department of Science Technology
• ben.durham_at_dst.gov.za
• www.dst.gov.za

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BackgroundSouth Africas National RD Strategy

• The three operational objectives of the strategy
  are
• Achieving mastery of technological change in our
  economy and society (Innovation)
• Investment in South Africas Science, Engineering
  and Technology Base (Human Capital and
  Transformation)
• Strengthening the government ST system and
  private sector participation (Alignment and
  Delivery)

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South Africas 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
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South Africas National Biotechnology Strategy
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South Africas 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/sup
plier for networks services that support
systems A,B,C
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South Africas 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

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South Africas 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
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South Africas National Biotechnology Strategy
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South Africas National Biotechnology Strategy
Growth in RD Expenditure of Biotechnology
related disciplines in SA 2002-2004
SA 2004 Performers of Biotechnology and related
fields according to funds spent
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South Africas 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
• gtR 368m in annual revenues in biotech sector
• Since 1992, 2 new core biotech companies have
  been set up annually.

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South Africas 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

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Biosafety Legislation GMO Act 1997
National alignment SAC advice Sustainable
development 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
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GMO Act 1997 amendments
To provide for measures to promote the
responsible development, production, use and
application of GMOs, 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 .
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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 GMOs.
• 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

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South Africas National Biotechnology Strategy
Thank you!

• Ben Durham
• Director Biotechnology
• Department of Science Technology
• ben.durham_at_dst.gov.za
• www.dst.gov.za