ࡱ> Q  bjbj eieitM~ ~ 4DDDhHD,:.^t n"#\*,,,,,,,,,,,,,$.g1nP,#R "t ##P,e,2(((#j*,(#*,((*&+ٙ&\$j*,,<,*,1$r1&+1&+##(#####P,P,8&h###,####1#########~ X : 鶹ý Biological Safety Advisory Group Proposal and Risk Assessment for Categorisation of a Procedure Involving Work with Genetically Modified Animals Guidance for completing risk assessments on genetically modified organisms can be found on the HYPERLINK "/hso/hsoatoz"University (Biological safety section) and  HYPERLINK "https://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/index.htm" HSE websites. Submit completed forms to HYPERLINK "mailto:safetyscienceschools@sussex.ac.uk"safetyscienceschools@sussex.ac.uk. Completed forms must be reviewed by the Schools Biological Safety Officer (BSO). If the work is GM class 2 or above it additionally needs to be reviewed by the Biological Safety Advisory Group (BSAG). This must be completed prior to any material being received onto site. Where risks are identified, detail how they will be managed by engineering (building/infrastructure) and procedural (training) controls. Please provide a proportionate level of information to the risk posed by the work and avoid one word/short answers. Project title:  Principal investigator/ Responsible person:School and Department:Location of work - building(s) & room number(s):Date of first application:Date of current review: Section 1: Personnel Briefly indicate your experience of working with microorganisms, animals and genetically manipulated organisms and any training you have received.  Other workers on the project [if known]QualificationsExperience/Training  Section 2: Project Description of the project, including the methods to be used and the purpose of the genetic modification. Provide details of the host organism that will be used Provide details of the vector system that will be used Origins and intended function of the genetic material involved  Section 3: Risk Assessment This section should include the justifications for any assessments made and sufficient detail to support them. Level of risk must be estimated using the matrix in appendix 1. Section 3A: Assessment for environmental harm What is the capacity of the GMO to survive, establish, disseminate with and/or displace other animals, and have adverse effects on animals and plants? Level of risk:  What is the potential for transfer of genetic material between the GMO and other organisms? Level of risk:  What is the potential for harmful effects from the products of gene expression? Level of risk:  What is the potential for harmful effects from phenotypic or genetic instability? Level of risk:  What is the potential for harmful effects from the animals acting as novel animal disease vectors? Level of risk:  Based on the risk to the environment (3A) assign the required containment level: 1 2 3 4 (Circle as appropriate) Section 3B: Human health and safety What are the hazards to human health and safety posed by the GM animal? (e.g. toxicity, allergenicity, behavioural, human disease reservoir) Level of risk:  Section 3C: Classification/Containment Based on the risk to human health (3B) assign the required containment level: 1 2 3 4 (Circle as appropriate) Based on the likelihood of environment harm (3A) and risk to human health (3B), assign the required GMO activity class: 1 2 3 4 (Circle as appropriate) Section 4: Control Measures to Be Employed Provide details of all containment and control measures required to contain the identified hazards to the environment and to human health and any means by which their effectiveness will be monitored. This must include details of: known potential route(s) of environmental release and whether these are properly managed. the inactivation procedures to be employed for waste contaminated with GMOs. the expected degree of inactivation/kill and any appropriate validation procedures.  Section 5: Emergency Planning Does your risk assessment(s) provide adequate protection and provision for emergency action in case of accidental release? If no, give details of specific extra safety measures which will be applied to the project.Yes / No  REQUIRED SIGNATURES Signatures need to be collected in the order they appear below. Only sign once you have completed the task you are responsible for and conveyed any necessary improvements/advice to the Principal Investigator/Responsible Person. If the work is class 2 or above then it must be reviewed by the BSAG. If there is a query regarding any GMO project please do not hesitate to contact your BSO or the BSAG. Name: Signed: Date: (School Biological Safety Officer to confirm the risk assessment has been reviewed and the labs where the work will be undertaken have been inspected to ensure they are operating at the required containment level) Name: Signed: Date: (Chair Biological Safety Advisory Group to confirm they have reviewed the risk assessment. When the work is deemed to be class 2 or above the risk assessment must be reviewed by the BSAG. In this situation, the Chair is signing on behalf of the BSAG) Name: Signed: Date: (Head of School to confirm they are aware of the work and the review process complies with the Schools health and safety requirements.) Control measures and risk classification detailed in this application approved by: Name: Signed: Date: (Principal Investigator/Responsible Person also signing to confirm that all workers are trained and competent) Appendix 1: Matrix for estimation of risk Likelihood x Severity = Score  Confirmation of reading and understanding of GMO risk assessment [insert project title] (File = [insert file name]) NameSignatureDate     GMO Risk Assessment PAGE 1 H&S Document NoSSHS F043Version1.0Date IssuedNov 2023AuthorE. WrightReviewed by: S. Barton-Jones / F. 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