Module 9 2024

03/09/2024

Environmental Risk Assessment

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GMO: Risk Classification

The use of GMOs is subject to risk assessment for all work as required by EU Directives, including risk to human health due to the transgene, risk of infection due to the vector used (e.g. viral) and risk to the environment and public health.

Class 1: Negligible risk - includes gene therapies based on organisms that cannot replicate in human cells. Class 2: Low risk - includes gene therapies based on viruses that replicate poorly, need a helper virus or replicate only for a few days in human cells. Class 3: Moderate risk - containment must protect both human health and the environment, includes viruses that can replicate for weeks in humans. Class 4: High risk - not suitable for gene therapy due to risks to human health and/or the environment

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Risk to the environment

● Environmental risk (e.g. waste water, aerosols, soil) ● Risk to direct contacts / family (e.g. via shedding, sneezing, saliva) ● Risk to healthcare providers during treatment (e.g. by needle prick, aerosols, sampling) ● Risk of transmission to third parties: no blood or organ donation after gene therapy (risk minimization measure)

The Organisation for Professionals in Regulatory Affairs

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