ࡱ> Q #bjbj eieiHI::4hh$ .5$0:j:!%&4444444$R7:n4&j!"!&&442+++&j4+&4++:/,-0 &'/ q44<.5/.v:'v:-0-0\v:0&&+&&&&&44(b&&&.5&&&&v:&&&&&&&&&:X : 鶹ý Biological Safety Advisory Group Proposal and Risk Assessment for Categorisation of a Procedure Involving Work with microorganism other than viruses 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 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.Will you cultivate on a large scale (e.g. 10 or more litres per culture)? If yes, how much? Yes/No Will aerosols be produced (e.g. sonication/centrifugation procedures)? Yes/No 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: Risk to human health Characteristics of the host and any hazards associated with it. If the host is a biological agent this should include its hazard group classification. Level of risk:  Characteristics of the vector system and any hazards associated with it. If the vector is a biological agent this should include its hazard group classification. Level of risk:  Source and characteristics of the inserted gene product and any hazards arising directly from its use (include an estimation of the level of expression and biological activity of the recombinant gene product) Level of risk:  Hazards arising from the alteration of any existing pathogenic traits, if applicable  Level of risk:  Potential hazard of sequences within the GMO being transferred to other organisms. Level of risk:  The overall likelihood that, in the event of exposure, the GMO could readily spread within humans and cause severe harm to human health. Level of risk:  Based on the risk to human health (3A) assign the required containment level: 1 2 3 4 (Circle as appropriate) Section 3B: Assessment for environmental harm What is the capacity of the GMO to survive, establish, disseminate with and/or displace other organisms? Level of risk:  What is its ability to cause harm to animals? Level of risk:  What is its ability to cause harm to plants? Level of risk:  What is its ability to cause harm to other organisms? Level of risk:  What is the potential for transfer of genetic material between the GMO and other organisms? Level of risk:  Is there any hazard resulting from phenotypic or genetic instability? Level of risk:  Based on the risk to human health (3A) and likelihood of environment harm (3B), assign the required GMO activity class: 1 2 3 4 (Circle as appropriate) Section 4: Control measures inactivation monitoring Provide details of the control measures to be used to protect human health and the environment, and the means by which their use and 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 F044Version1.0Date IssuedNov 2023AuthorE. WrightReviewed by: S. Barton-Jones / F. Van RonzelenDepartmentScience Schools Health & Safety TeamPage  PAGE 1 of  NUMPAGES \* MERGEFORMAT 9 GMO Risk Assessment GMO Risk Assessment (678  = > ? 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