Trends in biosafety assessment – new methodologies Trends in biosafety assessment – new methodologies Building Biotechnology Together AfricaBio, October 2002 Mrs Muffy Koch T/A Innovation Biotechnolog[.]
Trends in biosafety assessment – new methodologies Building Biotechnology Together AfricaBio, October 2002 Mrs Muffy Koch T/A Innovation Biotechnology muffykoch@telkomsa.net 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 Applicant Review committee Experts Biosafety communication Risk management Risk assessment Safety checks Biosafety considerations for commercial release (Case-by-case assessment) Consumers Environment - includes human safety Toxicity Effect on: Pathogenicity Living organisms Allergenicity Air, soil, water Digestibility Sustainability Nutrition Biodiversity Unexpected products Stability Stability Other Other Expertise needed for biosafety reviews Molecular biology Microbiology Biochemistry Ecology Pollination Biology Human health Veterinary science Plant physiology Plant pathology Plant taxonomy Soil biology Food safety Environmental risk assessment Weather Entomology Agronomy Plant genetics Transport Legal and more … Source: Expertise used in the first 150 application reviews in South Africa between 1989 and 1998 Risk assessment methodology Identify potential risk (e.g a hurricane) Identify adverse effect that could result (e.g the GM crop could be swept away to a distant site) Estimate the likelihood of the adverse effect being realised (very small / very likely?) Evaluate the consequences if the risk is realised (e.g not-viable; viable) Consider risk management strategies (e.g use a less risky site or season) 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 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 nonsafety 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 Safety Concerns 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! ... unacceptable) Trends in methodology • Anticipatory – Baseline data collection e.g resistance in natural populations; food profiling – Biosafety research • Improved detection • Focused monitoring Biosafety. .. GM Fall into 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 nonsafety issues: – Economic impact –