| To be completed prior to acceptance of a biological agent into an ECACC repository |
| For ECACC use only | | Type of Deposit: | ....................................................................................................................................... | | Accession Number: | ....................................................................................................................................... | | Depositor Code: | ....................................................................................................................................... | | Activity Class: | ....................................................................................................................................... | | Signed: | ....................................................................................................................................... | | Date: | ....................................................................................................................................... | |
| For Completion by Depositor | |
| The Biological Agent is: | |
| Genetically Modified: | |
| | If you have answered Class 2 or above please forward to us any Risk Assessment you have carried out yourselves relating to this deposit. |
| Other (please define): | |
| Species: | |
| Strain: | |
| Identification Code: | |
| ACDP Hazard Group1 | |
| Does this require a Specified Animal Pathogens Order | |
| | 1 ACDP Advisory Committee on Dangerous Pathogens | | Hazard Group 1 | A biological agent unlikely to cause human disease. | | Hazard Group 2 | A biological agent that can cause human disease and may be a hazard to employees, it is unlikely to spread to the community and there is usually effective prohpylaxis and effective treatment available. | | Hazard Group 3 | A biological agent that can cause severe human disease and presents a serious hazard to employees. It may present a risk of spreading to the community, but there may be a prophylaxi or treatment available. | | Hazard Group 4 | A biological agent that causes severe human disease and is a serious hazard to employees. It is likely to spread to the community and there is usually no effective phophylaxis or treatment available. | |
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| Brief description of deposit. If the agent is genetically modified include details of inserted gene, method/vehicle for insertion and any expression product. | |
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| To be completed if the biological agent is genetically modified |
| 1. | The host organism is ACDP Hazard Group | | | 2. | Does the GM agent contain/produce a biologically active substance that could potentially cause harm to humans (e.g. toxin, cytokine, hormone, allergen, oncogene) | | | 3. | What is the likelihood that the genetic modification can confer pathogenic traits in the host organism? | | | If 'possible', 'probably' or 'demonstrated' please provide additional details: | | | | 4. | What is the potential for sequences within the GM being transferred to another related microorganism? | | | If 'medium' or 'high' please provide additional details: | | | | 5. | In the light of your knowledge of this GMM and its origination, what is your assessment of its potential to cause harm to human health in the event of exposure? | | | If 'medium' or 'high' please provide additional details: | | | | 6. | Does this GMM have the ability tosurvive, establish and disseminate in the environment? | | |
| Form completed by: | |
| Name: | |
| Title: | |
| Date: | |
| NOTE: Please sign on the printed form where indicated |
| ECACC may request further information in order to complete its risk assessment. To whom should such requests be addressed? |
| Name: | |
| Telephone | |
| Fax | |
| E-Mail | |