Biosafety

Trends in biosafety assessment – new methodologies
Building Biotechnology Together
AfricaBio, October 2002

Mrs Muffy Koch
T/A Innovation Biotechnology
[email protected]
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.
Biosafety review process
2. Risk management
1. Risk assessment
3. Biosafety communication
Applicant <=> Review committee <=> Experts
Safety checks
Expertise needed for biosafety reviews
Source: Expertise used in the first 150 application reviews in South Africa between 1989 and 1998
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)

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

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

Concerns about GM
Fall into 4 categories
Environmental
Food and feed safety
Economic
Social
Therefore, decision making about GMOs is broader than just safety
Biosafety decision making
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
Decision making - South Africa
The GMO Act ensures that:
transboundary movement is regulated and
concerns are identified and addressed in decision making about GMOs
Concerns
Safety
Social and
economic
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!