ࡱ> )+&'(Q 0bjbj ZeieiZ'J *****4^^^hD^`/::RRR "#P.......$13n.*# " ##.**RRm.2-)-)-)#^*R*R.-)#.-)-)g++Rnݫ&E$+.$/<`/+,,4E$,4+,4*+##-)#####..&h###`/####,4######### X : ԰Ƶ Biological Safety Advisory Group Proposal and Risk Assessment for Categorisation of a Procedure Involving Work with Genetically Modified Human and Animal Viruses and Viral Vectors 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 Provide details of the host organism that will be used Will aerosols be produced (e.g. sonication/centrifugation procedures)? Yes/No 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 N.B. If the answer to a question in this section is Yes, provide details. Characteristics of the host, virus or viral vector and any hazards associated with it. This should include the hazard group classification.Is the viral vector replication competent? If so, how?Yes/No Describe the origin of the virus, the mechanism of attenuation, and its stability in both the parent viral vector and the recombinant/GM vector. Provide details for the probability of the vector reverting to the wildtype. Are all potential routes of transmission of the virus known, including those that may occur during a laboratory accident? Give details of these routes.Yes/No If yes, will the routes of transmission deliver the virus or its products to tissues where it may be biologically active?Yes/No Is there potential for the transmission of the naked nucleic acid?Yes/No Does the viral vector infect humans or human cells in vitro?Yes/No Level of risk:  Source and characteristics of the inserted gene product and any hazards arising directly from its use.Describe the nature of the inserted gene(s) and the properties of the final GM viral vector. Does the insert code for a protein with known or suspected physiological, pathological and/or pharmacological effect? (for example, but not limited to, cytokines, growth factors, immunoregulatory proteins, toxins, allergens etc.)Yes/No Will the viral vector contain any natural or inserted oncogene and/or oncogenic sequences?Yes/No Level of risk:  Hazards arising from the alteration of existing pathogenic traits Is there reason to suspect that the tissue tropism or host range of the recombinant virus will be any different from that of the parent vector or virus? If it is, is this property conferred by the vector or insert?Yes/No Is there reason to suspect that the recombinant virus may have altered susceptibility to host defence mechanisms? Yes/No e.g. Will normal immune status be compromised by the recombinant virusYes/No Will vaccination protect against the recombinant virus?Yes/No Is the recombinant virus likely to have any effect upon an immunocompromised host beyond those normally expected with the parental virus?Yes/No Will viral susceptibility to anti-viral drugs (if available) be affected by the genetic modification?Yes/No Could the route of transmission of the recombinant virus be altered? If so, what are the predicted effects of the recombinant viruses in tissues which it would not normally infect?Yes/No Level of risk:  Potential hazard of harmful sequences within the virus being transferred to related viruses. Level of risk:  The overall likelihood that, in the event of exposure, the GM virus could cause 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 N.B. If the answer to a question in this section is Yes, provide details What is the capacity of the GMO to survive, establish, disseminate with and/or displace other organisms?Is there reason to suspect that the recombinant virus may have enhanced environmental survival factors; e.g. enhanced tolerance to UV, temperature, desiccation etc.?Yes/No  Are all potential routes of transmission or escape of the virus to the environment known e.g. following a laboratory accident? Yes/NoIf yes, will the recombinant virus or its products gain access to organisms in which effects may be manifested?Yes/No Level of risk: What is its ability to cause harm to organisms other than humans?Is the host/recipient pathogenic to organisms other than humans?Yes/No Does the insert code for a protein with known or suspected inhibitory, detrimental, or other physiologically active effect on any organisms other than humans?Yes/No Is there a potential for harmful effects caused by expression of the insert/gene on other organisms?Yes/No Will the recombinant virus alter infectivity or interactions with the hosts defence mechanisms? Yes/Noe.g. Will the normal status of host defence systems be compromised by the recombinant virus?Yes/No Is the recombinant virus likely to have enhanced effects on a weakened host/recipient or one lacking normal vigour beyond those normally expected with the parent virus?Yes/No Will viral susceptibility to drugs used to control infection be affected by genetic modification?Yes/No Will the insert cause changes in the host range of the virus?Yes/No Is there reason to suspect that the tissue tropism of the recombinant virus in host organisms will be different from that of the unmodified virus?Yes/No Level of risk: What is the potential for transfer of genetic material between the GMO and other organisms? 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 and 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 F045Version1.0Date IssuedNov 2023AuthorE. WrightReviewed by: S. Barton-Jones / F. 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