Risk Risk Causal pathway Potential Substantive Reason scenario source harm risk? Section 2.1: Inadvertent exposure to the GM flu vaccines during import, transport, storage & disposal 1 GM flu Person exposed to the GMOs Ill health No Used, unused or expired sprayers vaccines during waste disposal be disposed as medical waste by clinical staff and distributors. Person infected with GMOs Exposure to unintended recipients be minimised as Influenza develops the vaccines would be administered by healthcare professionals following procedures. GM flu vaccine strains desiccate rapidly under ambient conditions. GM flu vaccine strains are attenuated and growth is restricted at human body temperature. 2 GM flu Unintentional release of Ill health No Transport will be according to vaccines GMOs during transport or appropriate standards for medical storage products. Storage will be at secure storage or healthcare facilities. Person or animals exposed to GMOs GM virus desiccates rapidly under ambient conditions. GM virus is attenuated and Person or animals infected growth is restricted at human with GMOs body temperature. Influenza develops Section 2.2.: Unintended changes in viral characteristics 3 GM flu Person infected with the GMO Ill health No The GM vaccines strains not vaccines is infected with contemporary contain any novel genetic influenza virus carrying a material. different haemagglutinin Co-infection of a host cell by the and/or neuraminidase from GMOs and another strain would the vaccine strains be uncommon. The introduced haemagglutinin Both viruses co-infect the and neuraminidase genome same host cell segments are derived from strains predicted to be the most common circulating strains for the Viruses reassort season, so do not add any genetic novelty. Reassortant infects host and Reassortants containing propagates genome segments from the GMOs are expected to be less virulent than circulating strains. Influenza develops
Risk scenario Risk source Causal pathway Potential harm Substantive risk? Reason Section 2.1: Inadvertent exposure to the GM flu vaccines during import, transport, storage & disposal 1 GM flu vaccines Person exposed to the GMOs during waste disposal Person infected with GMOs Influenza develops Ill health No Used, unused or expired sprayers be disposed as medical waste by clinical staff and distributors. Exposure to unintended recipients be minimised as the vaccines would be administered by healthcare professionals following procedures. GM flu vaccine strains desiccate rapidly under ambient conditions. GM flu vaccine strains are attenuated and growth is restricted at human body temperature. 2 GM flu vaccines Unintentional release of GMOs during transport or storage Person or animals exposed to GMOs Person or animals infected with GMOs Influenza develops Ill health No Transport will be according to appropriate standards for medical products. Storage will be at secure storage or healthcare facilities. GM virus desiccates rapidly under ambient conditions. GM virus is attenuated and growth is restricted at human body temperature. Section 2.2.: Unintended changes in viral characteristics 3 GM flu vaccines Person infected with the GMO is infected with contemporary influenza virus carrying a different haemagglutinin and/or neuraminidase from the vaccine strains Both viruses co-infect the same host cell Viruses reassort Reassortant infects host and propagates Influenza develops Ill health No The GM vaccines strains not contain any novel genetic material. Co-infection of a host cell by the GMOs and another strain would be uncommon. The introduced haemagglutinin and neuraminidase genome segments are derived from strains predicted to be the most common circulating strains for the season, so do not add any genetic novelty. Reassortants containing genome segments from the GMOs are expected to be less virulent than circulating strains.
Risk%20Assessment%20and%20Risk%20Management%20Plan.docx