1 GM E. coli Exposure of people to the GMO Disease No People have to adhere to the O78 aroA- through: effects in general guidelines for Accidental spills people handling veterinary products. Fertilizer (chicken The parental E. coli strain manure) O78 is not currently considered a human Infection of the host pathogen. There is a history of safe use of the GM chicken vaccine. There is limited shedding of the GMO into the environment. GM O78 has reduced E. coli spread and persistence in the environment compared to the parental strain. 2 GM E. coli Reversion of GMO to virulent strain Reduced No There is a history of safe use O78 aroA- number of of the GM chicken vaccine Exposure of native wild birds to desired wild (reversion to virulence has virulent APEC O78 birds not been observed). Colibacillosis is considered a Development of colibacillosis in wild secondary disease. birds Wild type E. coli O78 is likely to be present in the environment. 3 GM Exposure of feral or pest birds to the Increased No There is limited shedding of E. coli O78 aroA- GMO number of the GMO into the feral or pest environment. Immunization of or pest birds birds There is limited access of feral birds to the GMO. Use of the vaccine as per prescription would minimise the likelihood of exposure of GM E. coli to feral birds. GM E. coli O78 is attenuated and, therefore, its spread and persistence in the environment is reduced compared to the parental strain. Feral or pest birds are unlikely to be challenged with a sufficiently large dose of attenuated GM to E. coli induce an immune response. There is a history of safe use of the GM chicken vaccine. Summary of risk scenarios from the proposed dealings with GM E. coli vaccine Risk scenario 1 Risk source Causal pathway Potential harm
1 GM E. coli O78 aroA- Exposure of people to the GMO through: Accidental spills Fertilizer (chicken manure) Infection of the host Disease effects in people No People have to adhere to the general guidelines for handling veterinary products. The parental E. coli strain O78 is not currently considered a human pathogen. There is a history of safe use of the GM chicken vaccine. There is limited shedding of the GMO into the environment. GM E. coli O78 has reduced spread and persistence in the environment compared to the parental strain. 2 GM E. coli O78 aroA- Reversion of GMO to virulent strain Exposure of native wild birds to virulent APEC O78 Development of colibacillosis in wild birds Reduced number of desired wild birds No There is a history of safe use of the GM chicken vaccine (reversion to virulence has not been observed). Colibacillosis is considered a secondary disease. Wild type E. coli O78 is likely to be present in the environment. 3 GM E. coli O78 aroA- Exposure of feral or pest birds to the GMO Immunization of or pest birds Increased number of feral or pest birds No There is limited shedding of the GMO into the environment. There is limited access of feral birds to the GMO. Use of the vaccine as per prescription would minimise the likelihood of exposure of GM E. coli to feral birds. GM E. coli O78 is attenuated and, therefore, its spread and persistence in the environment is reduced compared to the parental strain. Feral or pest birds are unlikely to be challenged with a sufficiently large dose of attenuated GM E. coli to induce an immune response. There is a history of safe use of the GM chicken vaccine. Summary of risk scenarios from the proposed dealings with GM E. coli vaccine Risk scenario 1 Risk source Causal pathway Potential harm
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