Trends in biosafety assessment new methodologies

1
Trends in biosafety assessment new methodologies

• Building Biotechnology Together
• AfricaBio, October 2002
• Mrs Muffy Koch
• T/A Innovation Biotechnology
• muffykoch_at_telkomsa.net

2
Biosafety traditional base

• Biosafety risk assessment on GMOs
• Is based on chemical and biocontrol risk
  assessment methods
• Assesses the impact of each GMO on food and feed
  safety and on the environment
• Occurs during the development of the GMO and
  before it is given general release approval
• Is the practical implementation of the
  precautionary principle.

3
Biosafety review process
Applicant ltgt Review committee ltgt Experts
3. Biosafety communication
2. Risk management
1. Risk assessment
4
Safety checks
5
Expertise needed for biosafety reviews
Source Expertise used in the first 150
application reviews in South Africa between 1989
and 1998
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Risk assessment methodology

• 1. Identify potential risk (e.g. a hurricane)
• 2. Identify adverse effect that could result
  (e.g. the GM crop could be swept away to a
  distant site)
• 3. Estimate the likelihood of the adverse effect
  being realised (very small / very likely?)
• 4. Evaluate the consequences if the risk is
  realised (e.g. not-viable viable)
• 5. Consider risk management strategies (e.g. use
  a less risky site or season)
• 6. Estimate the overall potential impact (e.g.
  small, manageable, acceptable, unacceptable)

7
Trends in methodology

• Anticipatory
• Baseline data collection e.g. resistance in
  natural populations food profiling
• Biosafety research
• Improved detection
• Focused monitoring

8
Biosafety principles

• Case-by-case
• Science based
• Arms length from decision making
• Iterative
• Anticipatory
• Evolves with product development
• Need-to-know vs. Nice-to-know
• Experience builds confidence

9
Concerns about GM

• Fall into 4 categories
• Environmental
• Food and feed safety
• Economic
• Social
• Therefore, decision making about GMOs is broader
  than just safety

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Biosafety decision making
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New trends in GM decision making

• Regulate transboundary movement of GMOs
  (Cartagena Protocol on Biosafety)
• Enable and consider public input
• Provide a platform to investigate non-safety
  issues
• Economic impact
• Social impact
• National needs

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Decision making - South Africa

• The GMO Act ensures that
• transboundary movement is regulated and
• concerns are identified and addressed in decision
  making about GMOs

Safety
Concerns
Social and economic
13
Reviewing the GMO Act

• While the chairperson of the environmental
  portfolio committee is befuddled by
  misinformation,
• The timely review of any legislation is a good
  practice,
• This review will enable
• ownership by national anti-GM groups and
• modifications, as and where needed.
• The sooner the better!