GM Ref. : __/__ Newcastle University Microbiological Hazards and Genetic Modification Safety Advisory Sub-Committee OHSS: H&S Form 302.1c Proposal and Risk Assessment for Categorisation of a Procedure Involving Work with Genetically Modified Plant Viruses Please complete the form by computer and send it as an email attachment in rtf format to your School GM Chair. The principal investigator and School GM Chair should sign the declaration page of the electronic copy of the form. After review and approval, the School GM Chair will send the form as an email attachment in rtf format to the University Biological Safety Officer. Please Note: Principal investigators must send all GM risk assessment forms to the School GM Chair and not to the University Biological Safety Officer. Guidance on completing this form is provided in the GM Risk Assessment section of the University Safety Office website. Title of project Principal investigator School Date of application Location of work [ENTER DETAILS HERE] [ENTER DETAILS HERE] [ENTER DETAILS HERE] dd/mm/yyyy [ENTER DETAILS HERE] (Building & Room. No.) Summary Details (Delete or enter Not Applicable (N/A) where appropriate) 1/2/3 GM activity Class Connected programme? Yes / No (Class 2 or above) Likely completion date mm/yyyy If Yes, and not Parent, give Parent GM Ref. Page 1 of 7 OHSS: H&S Form 302.1c GM Risk Assessment Version: 4 Owner: SJD Date of creation: 04/2015 Review Date: 04/2020 GM Ref. : __/__ Section 1 Personnel 1.1: Briefly indicate your experience of working with microorganisms and genetically modified organisms and any training you have received [ENTER DETAILS HERE] 1.2.1: Other workers on the project (if known) 1.2.2: Qualifications 1.2.3: Experience / Training [ENTER DETAILS HERE] [ENTER DETAILS HERE] [ENTER DETAILS HERE] Page 2 of 7 OHSS: H&S Form 302.1c GM Risk Assessment Version: 4 Owner: SJD Date of creation: 04/2015 Review Date: 04/2020 GM Ref. : __/__ Section 2 Project 2.1: Description of the project, including the methods to be used and the purpose of the genetic modification [ENTER DETAILS HERE] 2.2: Will you cultivate on a large scale (eg 10 or more litres per culture) Yes / No [ENTER DETAILS HERE] 2.3: Host organism [ENTER DETAILS HERE] 2.4: Vector system [ENTER DETAILS HERE] 2.5: Origins, nature of modification(s), and intended function of the genetic material involved [ENTER DETAILS HERE] Page 3 of 7 OHSS: H&S Form 302.1c GM Risk Assessment Version: 4 Owner: SJD Date of creation: 04/2015 Review Date: 04/2020 GM Ref. : __/__ Section 3 Risk Assessment NB : This section should include sufficient detail to support the justifications for any assessments made. Particular care should be taken to the assessment of work with viruses that infect plants indigenous to the UK Level of risk may be estimated using the matrix given at the end of this form. 3A Assessment for Environmental Harm 3A.1: Characteristics of host virus or viral vector and any hazard associated with it 3A.1.1: Is the viral vector disabled 3A.1.2: If Yes, how Yes / No [ENTER DETAILS HERE] 3A.1.3: Describe the origin of the virus, the mechanism of attenuation, and its stability in both the parent viral vector and the recombinant vector [ENTER DETAILS HERE] 3A.1.4: Indicate the probability of reversion to the wild type [ENTER DETAILS HERE] Yes / No Yes / No 3A.1.5: Is the viral vector replication competent 3A.1.6: Are all potential routes of transmission of the virus known, eg those that may occur during a laboratory accident [ENTER DETAILS HERE] If Yes, will the routes of transmission deliver the virus or its products to tissues where it may be biologically active ? [ENTER DETAILS HERE] Yes / No Yes / No 3A.1.7: Is there potential for the transmission of naked nucleic acid ? Level of risk [ENTER HERE] 3A.2: Source and characteristics of the inserted gene product and any hazards arising directly from its use 3A.2.1: Describe the nature of the inserted genes and the properties of the final genetically modified viral vector [ENTER DETAILS HERE] Yes / No 3A.2.2: Does the insert code for a protein with known or suspected pathological effect [ENTER DETAILS HERE] 3A.2.3: 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 Yes / No [ENTER DETAILS HERE] Level of risk [ENTER HERE] 3A.3: Hazards arising from the alteration of existing pathogenic traits 3A.3.1: 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 3A.3.2: Is there reason to suspect that the modified virus may have altered susceptibility to host defence mechanisms 3A.3.3: Could the route of transmission of the recombinant virus be altered Yes / No Yes / No Yes / No If so, what are the predicted effects of the recombinant viruses in tissue which it would not normally infect ? [ENTER DETAILS HERE] Level of risk [ENTER HERE] 3A.4: What is the capacity of the GMM to survive, establish, disseminate with and or displace other organisms Yes / No 3A.4.1: Is there reason to suspect that the recombinant virus may have enhanced environmental survival factors: eg enhanced tolerance to UV, temperature, Page 4 of 7 OHSS: H&S Form 302.1c GM Risk Assessment Version: 4 Owner: SJD Date of creation: 04/2015 Review Date: 04/2020 GM Ref. : __/__ desiccation etc [ENTER DETAILS HERE] 3A.4.2: Are all potential routes of transmission or escape of the virus to the environment known eg following a laboratory accident Yes / No If Yes, will the recombinant virus or its products gain access to organisms in which effects may be manifested [ENTER DETAILS HERE] Yes / No 3A.4.3: Will the gene insertion affect the fitness of the virus Yes / No [ENTER DETAILS HERE] 3A.4.4: Is there a potential for transmission in the form of infectious nucleic acid Yes / No [ENTER DETAILS HERE] 3A.4.5: What is the ease by which mechanical transmission of the recombinant virus may occur [ENTER DETAILS HERE] Level of risk [ENTER HERE] 3A.5: What is the potential for transfer of genetic material between the GMM and other organisms [ENTER DETAILS HERE] Level of risk [ENTER HERE] 3A.6: What is the likelihood that the GMM could cause harm in the event of environmental exposure Yes / No 3A.6.1: Is the host pathogenic [ENTER DETAILS HERE] 3A.6.2: Does the insert code for a protein with known or suspected inhibitory, detrimental, or other physiologically active effect on any organisms Yes / No [ENTER DETAILS HERE] 3A.6.3: Is there a potential for harmful effects of gene expression on other organisms Yes / No [ENTER DETAILS HERE] 3A.6.4: Will viral susceptibility to control agents be affected by genetic modification Yes / No [ENTER DETAILS HERE] Level of risk [ENTER HERE] Assign the provisional containment level: (delete as appropriate) 1/2/3 3B Risks to Human Health 3B.1: What is the likelihood that, in the event of exposure, the GM Virus could cause harm to human health eg By production of toxins, allergens, pharmacologically or immunologically active substances. [ENTER DETAILS HERE] Level of risk [ENTER HERE] 3C Final Activity Class Assign the final activity Class: (delete as appropriate) 1/2/3 Page 5 of 7 OHSS: H&S Form 302.1c GM Risk Assessment Version: 4 Owner: SJD Date of creation: 04/2015 Review Date: 04/2020 GM Ref. : __/__ Section 4 Control Measures to be Used 4: 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 the inactivation procedures to be employed for waste contaminated with GMM, the expected degree of kill and any appropriate validation procedures 4.1: Containment level 1/2/3 [ENTER DETAILS HERE] 4.2: Controls [ENTER DETAILS HERE] 4.3: Inactivation of genetically modified organisms [ENTER DETAILS HERE] All contaminated materials, including waste destined for incineration, will be inactivated by autoclaving (100% kill) prior to disposal of waste or cleaning and recycling of reusable laboratory equipment, such as glassware. Autoclaves will be validated by annual thermocouple mapping and each run will be monitored by continuous chart (or digital) recording of the temperature/time profile. OR All contaminated materials, including waste destined for incineration, will be inactivated by autoclaving (100% kill) prior to disposal of waste or cleaning and recycling of reusable laboratory equipment, such as glassware. Autoclaves will be validated by annual thermocouple mapping and each run will be monitored using TST (Time, Steam, and Temperature) test strips (Albert Browne Ltd., TST class 6 emulating indicator 121ºC for 20 min). Section 5 Emergency Planning 5: Are there risks to human health and safety or to the environment that require an emergency plan for action in case of accidental release Yes / No If Yes, provide full details of the plan [ENTER DETAILS HERE] Page 6 of 7 OHSS: H&S Form 302.1c GM Risk Assessment Version: 4 Owner: SJD Date of creation: 04/2015 Review Date: 04/2020 GM Ref. : __/__ School Declaration and Approval Signatures Title of project : School : I declare that this work will be conducted in accordance with University rules, practices and requirements on GM procedures, and that if at any stage there is any indication that hazards and/or risks could be significantly higher than originally assessed, then the work will cease until such time the risk assessment has been revised, and approval granted from the School and/or University GM Safety Committee as appropriate. Declaration : Principal investigator : As the principal investigator for this GM project you have a legal responsibility to ensure that all those involved/working on the project have an appropriate level of training and expertise to enable safe working. This includes ensuring that they read and understand this risk assessment, and that all procedures they undertake, including the control measures, are in strict accordance with those approved for the project. To ensure the latter you are advised to check for compliance with procedures from time to time, and make an appropriate record to be kept as part of the project file. Sign and date I declare that this risk assessment has been scrutinised and approved by the School GM Safety Committee. To be signed by the School GM Chair, or, in the event they are the principal investigator, by another member of the School GM Safety Committee. Chair / Other member Declaration : Note Role (delete as appropriate) Print name Sign and date Risk Estimation Matrix Severity of harm Severe Moderate Minor Negligible Likelihood of harm High Medium Low Negligible High High Medium/low Effectively zero Medium Medium/low Low Effectively zero Effectively zero Effectively zero Effectively zero Effectively zero High Medium Low Effectively zero Page 7 of 7 OHSS: H&S Form 302.1c GM Risk Assessment Version: 4 Owner: SJD Date of creation: 04/2015 Review Date: 04/2020