Completion by BSA only Project Assessment I.D.: If updated, date of first consent: Consent date for this version: CL with derogation ☐ FORM: BA1 GM Class BIOLOGICAL AGENTS (including GM) & MATERIALS: PROJECT REGISTRATION & RISK ASSESSMENT Please note the following: Form Use: to register and risk assess projects involving the use of Biological Agents (including Genetically Modified Micro-Organisms), or materials (such as cells and tissues) that may be contaminated with these agents. The assessment should identify all significant hazards and risks associated with Biological Agents: refers to any microorganism, cell culture, or endoparasite that may cause infection, allergy, toxicity or otherwise cause a hazard to human & / or animal health Consent / Approval: work must not commence until the Principal Investigator has received consent from the Biological Safety Adviser (BSA) / Biological Agents Safety Committee: Responsibility: it is the responsibility of the person directing the research (i.e. the Principal Investigator) to ensure that all these requirements are complied with and that the risk assessment remains valid. Local Rules / Code of Practice: written protocols (Local Rules / Code of Practice (CoP) or Standard Operating Procedures (SOPs)), containing details of the key working practices to be followed, must accompany the assessment at submission for work requiring CL2 or above. Changes: any significant changes to the work activity must be notified to the BSOs. All changes must be incorporated within an amended version of this form as well as within the Local Rules / Code of Practice plus details of what has been changed recorded within the risk assessment change control form. Person(s) responsible for this GM activity (Principle Investigator): Name(s): Department: Person conducting this assessment (if different from above): Name: Position: Department: Date: The Project Activity: Project Title (e.g. title used in grant application): Location(s) of work activity Department(s): List all areas to be used e.g. the main lab, shared incubator rooms, shared storage facilities Building(s) and Room(s): The following declaration must be completed by the PI responsible for this project ☐ Information contained in this assessment is accurate and comprehensive ☐ All work will remain within the boundaries of this Project Registration / Assessment ☐ All significant changes to this work activity will be reassessed and the changes submitted to the BSA before those changes are made to the work ☐ All workers associated with this work will be given appropriate training and where necessary, their competency assessed and recorded ☐ If necessary, all workers will be enrolled with Occupational Health for health clearance before work starts COLOUR SCHEME GUIDANCE FOR THIS FORM: Blue fill = required for all work Pink fill = tissues, cells, etc specific Page 1 of 12 Green fill - non-GM biological agents specific Orange fill – GMM specific Version: 1 Part 1 (Registration): To be Completed for all Work Activities 1. INTRODUCTION This information provides a useful background and puts the work into context. Brief yet clear outline only please- provides the reviewer a better understanding of the aims of the work. For Q1.2, cover as much of your activities with a particular agent or material as possible within this form. The intention of this Project Registration is primarily to outline the scope of the proposed works, before risk assessing specific procedures in the next section. 1.1 Background and aim(s) of the project Click here to enter text. 1.2 Description of experimental procedures (outline the scope of the project by describing the different laboratory procedures to be used) Click here to enter text. 2. NATURE OF THE WORK AND HAZARD IDENTIFICATION This information provides details of the nature of the biological agent(s) / material(s) and an indication of the potential harm it could cause TISSUES, CELLS, BODY FLUIDS OR EXCRETA 2.1 2.2 If human or animal tissues, cells, body fluids or excreta will NOT be used tick here ☐ & proceed to Q2.9 If GM cell cultures / lines are used, complete relevant parts of this section & the GM section below 2.3 List all the tissues, cells, body fluids or excreta to be used (species, type, where obtained) Details on the source of the material must be included Click here to enter text. 2.4 Describe what infectious agents this material has been screened for Will any clinical history or veterinary screening (if relevant) be provided? Click here to enter text. 2.5 If yes, detail what this will include: Yes ☐ No ☐ N/R ☐ Click here to enter text. If yes, will a policy of rejection of samples from Click here to enter text. diseased donors be adopted? Explain: If yes and for human material, how will the Click here to enter text. information be disseminated in the course of the project? If yes, and for human material, will this information be Yes ☐ No ☐ N/R ☐ anonomised? 2.6 What is the likelihood of infection of Medium risk ☐ High risk ☐ None ☐ Low risk ☐ any of this material? Consider the If medium or high risk of infection go to If none or low risk worst case if multiple tissues, cells, etc next question proceed to Question 2.10 are used 2.7 2.8 2.9 If medium or high risk of infection name and classify the biological agents this material could be infected with Describe the type and severity of the disease that can be caused to humans or animals by each of the agents that could be present Do any of the materials listed require a licence or a permit before work commences? Tissue, cell, fluids or excreta Name of agent Human / Animal Pathogen classification (HG 1-4) Click here to enter Click here to enter text. text. Click here to enter text. Click here to enter text. For example, IAPPO1, SAPO, DEFRA, or FERA licences? If yes, state which ones. Click here to enter text. Yes ☐ 2.10 Does the work require ethical approval? Page 2 of 12 No ☐ Version: 1 NON-GM BIOLOGICAL AGENTS 2.11 If non-Genetically-Modified Biological Agents will NOT be used tick here ☐ and proceed to Q2.15 2.12 Non-GM biological agents used: Name of agent(s) Strain(s) Human / Animal Pathogen Classification Click here to enter text. Click here to enter text. Click here to enter text. 2.13 Describe the type and severity of the disease that can Click here to enter text. be caused to humans, animals or plants by each of the agents, and if relevant, the particular strains in use 2.14 Do any of the organisms listed require a licence or a permit before work commences (e.g. SAPO, DEFRA, or FERA licences)? Click here to enter text. GENETICALLY MODIFIED MICROORGANISMS The term ‘microorganism’ means a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material- includes a virus, viroid and animal / plant cell cultures 2.15 If Genetically-Modified Micro-Organisms (GMMs) will NOT be used then tick here ☐ and proceed to Question 3.1 2.16 Provide an overview of the different types of GMM that will be constructed. The scope and boundaries of the work need to be made clear. Click here to enter text. 2.17 List all recipient species & representative strains to be used & their human / animal pathogen classification (Hazard Groups 1-4) Note: list recipient strains in generic terms e.g. K12 strains; list & assessment must be updated if new vector systems significantly alters the hazard / risk Click here to enter text. 2.18 Do any of the organisms listed require a licence or a permit before work commences (e.g. SAPO, DEFRA, or FERA licences)? Click here to enter text. 2.19 List of vector systems to be used and their particular functional properties Note: list vector systems in generic terms; list & assessment must be updated if new vector systems significantly alters the hazard / risk Click here to enter text. 2.20 List the names and functional properties of altered / inserted genes Click here to enter text. 2.21 Identify the most hazardous GMM(s) to be constructed giving consideration both to human health and the environment. Click here to enter text. 3. DECLARATION: To be completed in all cases 3.1 Are you confident that any non-GM organism, tissue, cell, blood, body fluid or any component of any GMM covered by this assessment presents no / negligible risk to humans or the environment? Further guidance Yes ☐ No ☐ Tick here if you believe that this project comprises work requiring only Containment Level 1 (‘Class 1’ for GMM). The generic GM assessment / controls for activities of no/negligible risk to be applied. Part 2 does not need to be completed Tick here if you believe that Containment Level 2 (or higher) is required and then answer Q3.2 and proceed to Part 2 & Q4.1 of this form 3.2 Do any of the materials contain pathogens or toxins covered by the Anti-Terrorism (Crime and Security Act)? Choose an item. If yes, then Section 4 must still be completed even if only CL1 Page 3 of 12 Version: 1 Part 2: Continuation Form for Use in Cases Where a Detailed Risk Assessment is Necessary 4. FURTHER DETAILED ASSESSMENT Must be completed if Q3.1 was answered ‘NO’ TISSUES, CELLS, BODY FLUIDS OR EXCRETA 4.1 If human or animal tissues, cells, body fluids or excreta will NOT be used tick here ☐ and proceed to Q4.9 4.2 If GM cell cultures are used, complete relevant parts of this section & the GM section below 4.3 Will any culturing of the material described in Q2.3 take place? If yes, describe which cell(s) will be cultured and under what conditions. Choose an item. 4.4 If culturing, could HIV permissive cells be present? If yes, describe the cells and for how long these cultures will be allowed to grow. Choose an item. 4.5 If culturing, what is the maximum volume of culture grown? Per flask: Click here to enter text. 4.6 Will the tissues, cells, body fluids or excreta be manipulated in any way that could result in the concentration of any adventitious biological agent present? If yes, explain. Choose an item. 4.7 What will be the most hazardous procedure(s) involving the use of this material that could cause exposure to workers? Click here to enter text. 4.8 Will any of the fluids, tissues or cells be donated by you or your colleagues? Choose an item. Click here to enter text. Click here to enter text. Number of flasks: Click here to enter text. Click here to enter text. If yes, detail who will provide these Click here to enter text. N/R ☐ If yes, explain the special risks associated Click here to enter text. N/R ☐ If yes, provide justification for not using material from another safer source e.g. National Blood Service Click here to enter text. If yes, how will confidentiality be assured? Click here to enter text. If yes, has written consent been obtained from the donor? Click here to enter text. If yes, has Ethics Committee approval been obtained? N/R ☐ N/R ☐ N/R ☐ Choose an item. NON-GM BIOLOGICAL AGENTS 4.9 If non-Genetically-Modified Biological Agents will NOT be used tick here ☐ and proceed to Q4.15 4.10 Describe ALL the route(s) Name of agent(s) Route(s) of infection Min. infectious dose of infection (relevant to Click here to enter text. Click here to enter text. Click here to enter text. the lab setting) and the minimum infectious dose(s), if known Per experiment: Click here to enter text. 4.11 What is the highest concentration and volume of Total stored: Click here to enter text. agent(s) to be worked with? 4.12 Are there any known drug resistances amongst Click here to enter text. the strains to be used? If yes, explain what these are and the consequences 4.13 What forms of the agent will be used e.g. spores, Page 4 of 12 Click here to enter text. Version: 1 vegetative forms and are there any issues over the robustness of these particular forms e.g. resistance to disinfectants or increased stability on dry surfaces 4.14 What will be the most hazardous procedure(s) Click here to enter text. involving the use of this material that could cause exposure to workers? GENETICALLY MODIFIED MICROORGANISMS The term ‘microorganism’ means a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material- includes a virus, viroid and animal / plant cell cultures Please refer to the GM guidance sheet to assist in the completion of this section of the assessment 4.15 If GMMs will NOT be used then tick here ☐ and proceed to Q5 4.16 Identify any hazards to human health or to the environment of the recipient microorganism(s) Click here to enter text. 4.17 Identify any hazards to human health or to the environment associated directly with the vector system(s) in use Click here to enter text. For viral vectors consider the vectors mode of transmission, disease symptoms, host range, and tissue tropism as well as an indication as to whether vaccines or chemotherapeutic agents are available. Identify any disabling mutations and whether there is a possibility of any disabling mutations being complemented or reverting. 4.18 Identify all of the known or potential hazards to human health or the environment associated with all the GMMs to be generated. It is important that the boundaries of this project are clearly explained here. Click here to enter text. Consider a) whether the inserted gene encodes a pathogenicity determinant, such as an adhesion, a penetration factor or a surface component providing resistance to host defence mechanisms; b) whether the inserted gene encodes a surface component, envelope protein or capsid protein that might bind to a different receptor to that used by the recipient microorganism, and c) whether the inserted DNA (or plasmid sequence) encodes resistance to a drug or antibiotic that might be used for the treatment of a laboratory-acquired infection. 4.19 Describe the likelihood and consequences of the modifications being transferred to related microorganisms Click here to enter text. 4.20 Identify the most hazardous GMM(s) to be constructed. What is the likelihood that, in the event of exposure (humans / environment), the GMM could actually cause harm? Click here to enter text. 4.21 Describe ALL the potential route(s) of infection (relevant to the laboratory setting) of the GMM(s) Name of agent Route(s) of infection Minimum infectious dose Click here to enter Click here to enter Click here to enter text. text. text. Per experiment: Click here to enter text. 4.22 What is the highest concentration and volume of the Total stored: Click here to enter text. GMM(s) to be worked with? 4.23 What will be the most hazardous procedure(s) involving the use of this material that could cause exposure to workers / the environment? Page 5 of 12 Click here to enter text. Version: 1 5. RISK FACTORS AND CONTROL MEASURES This section considers the nature of the work to identify factors that affect risk of exposure and selection of appropriate measures to adequately control the risk. All questions must be answered and further details supplied when indicated. NOTE that key working practices identified below must be documented in a Code of Practice (CoP) / Local Rules or Standard Operating Procedure (SOP) for CL2 work or higher, or work covered by the Anti-Terrorism (Crime & Security) Act Risk If yes, how will it be controlled? Reference any SOP, CoP or other written protocol providing details on usage, training, decontamination, etc. 5.1 Will infectious droplets or aerosols be created, either deliberately or by accident? Choose an item. A microbial safety cabinet (or isolator for in vivo work) must be used for activities likely to generate potentially infectious aerosols or splashes. If needed, state the type(s) and when it will be applied Click here to enter text. 5.2 Will material be transported within the laboratory? Choose an item. Click here to enter text. For example, cultures being transported between the safety cabinet and the incubator must be double contained so as to prevent spillage if dropped 5.3 Will the material be transported locally on campus but outside of the laboratory? 5.4 Will this material be shipped elsewhere in the UK or abroad? 5.5 Will this material be received from elsewhere? 5.6 Will this material be stored? 5.7 Will infectious material be centrifuged? Choose an item. Click here to enter text. For example, material transported from the primary laboratory to the BSF must be double contained so as to prevent spillage if dropped, adequately labelled and no gloves must be worn outside of the laboratory Choose an item. If yes, provide details of material to be shipped and the packing instructions to be followed Click here to enter text. Choose an item. Click here to enter text. Provide details of material to be received, how this will be arranged & what steps will be taken to ensure that the material is correctly packaged. Further guidance is available on the Safety website Choose an item. Click here to enter text. Provide details of how, where and in what this material will be stored. If stored in Liquid Nitrogen describe the additional precautions in place Choose an item. 5.8 Are biological samples to be cultured in an incubator? Choose an item. 5.9 Are sharps to be used at any stage during this activity? Choose an item. 5.10 Are animals to be used as part of this project? Choose an item. If yes: a) Will sealed rotors & buckets always be used? Click here to enter text. b) Where will rotors / buckets be opened? Click here to enter text. c) Describe procedure to deal with leaks / spillages: Click here to enter text. What type of incubator (e.g. shaking or static shelf) is this and describe the measures to be used to prevent and contain any spillages Click here to enter text. Describe the sharps, justify their use and describe the precautions in place to protect the user and others from injury Click here to enter text. What procedures will be undertaken? Click here to enter text. Where will this aspect of the work be undertaken? Click here to enter text. Is shedding of biological agent or GMMs by the infected animals possible? Click here to enter text. If yes, detail routes of shedding, risk periods for such shedding and the additional precautions required to control exposure Click here to enter text. Page 6 of 12 Version: 1 Who will perform the inoculations/exposure of the animals? Click here to enter text. What training will they have received and where will this be recorded? Click here to enter text. Provide details on any additional training required for those handling these animals Click here to enter text. Provide details on any additional precautions necessary Click here to enter text. 5.11 Will a fermenter be used to culture the pathogen Choose an item. What size and type is this and are any supplementary containment measures required, for example, the use of a safety cabinet or spill tray? Click here to enter text. Where is this fermenter located and who is in charge of the area? Click here to enter text. 5.12 Is there any stage within the experimental procedures when the infectious material is inactivated (other than for disposal)? Choose an item. If yes, how will this be done and what will then happen to the material? Click here to enter text. 5.13 For organisms whose multiplication involves a complex life-cycle will the work involve the propagation of organisms that are in that life cycle that is particularly hazardous? E.g. growth of infective stages of parasites or release Choose an item. Click here to enter text. 5.14 Will lone working take place for this work activity? Choose an item. If yes, how will the safety of those individuals engaged in higher risk activities be monitored? Click here to enter text. 6. PERSONAL PROTECTION All questions must be answered and further details supplied when indicated. NOTE that key working practices identified below must be documented in a Code of Practice (CoP) / Local Rules or Standard Operating Procedure (SOP) for CL2 or higher work, or work covered by the Anti-Terrorism (Crime & Security) Act 6.1 Are gloves necessary to protect the worker (as opposed to the work)? Choose an item. 6.2 What type are these? Click here to enter text. 6.3 Where will lab coats be stored and what are the arrangements for cleaning? 6.4 Is any other type of personal protective equipment required (e.g. safety glasses)? If yes, provide details Click here to enter text. Click here to enter text. Page 7 of 12 Version: 1 7. WASTE All questions must be answered and further details supplied when indicated. NOTE that waste disposal practices must be documented in a Code of Practice (CoP) / Local Rules or Standard Operating Procedure (SOP) for CL2 or higher work, or work covered by the Anti-Terrorism (Crime & Security) Act 7.1 How will waste be treated prior to disposal? (Note that all differently treated wastes must be included e.g. if some liquid is autoclaved, but others not, then describe both) Liquid waste Treatment prior to disposal Solid waste Click here to enter text. Other waste (specify): Click here to enter text. Click here to enter text. Click here to enter text. If liquid waste treated by disinfectant, how has this been validated (used according to suppliers instructions / in-house validation (required for CL3 activities))? Click here to enter text. 7.2 If waste is to be autoclaved confirm the following: All cycles have been validated for the Choose an item. actual load types used The successful completion of every Choose an item. load is checked prior to disposal? 7.3 How will liquid waste be disposed of? To drain? Choose an item. As solid waste? Choose an item. Other (specify)? Click here to enter text. Choose an item. 7.4 How will solid waste be disposed of? Categorisation Colour code Disposal Route ☐ Sharps Yellow Yellow sharps bin > autoclave sterilisation if known or potentially infected >clinical waste disposal (incineration) ☐ Human body parts, organs including blood bags and blood preserves and excreta (unless identified as medium or high risk or known infected in Q2.6 of this assessment in which case they must be pre-treated before disposal) Yellow Yellow rigid one way sealed tissue bins > clinical waste disposal (incineration) ☐ Animal body carcasses or recognisable parts (unless identified as medium or high risk or known infected in Q2.6 of this assessment in which case they must be pre-treated before disposal) Yellow Yellow rigid one way sealed tissue bins > clinical waste disposal (incineration) ☐ Potentially or known infected lab wastes (including sharps) of Hazard Group 2, GM Class 2, DEFRA Category 2 or higher, that have NOT been pre- Special case – contact Biological Safety Advisor This is not a route of preference and is subject to special requirements * Human tissue waste must be placed in separate containers from nonhuman waste and labelled ‘HTA waste’ Page 8 of 12 Version: 1 treated before leaving site ☐ Infected or potentially infected lab wastes that have been pre-treated before leaving site Yellow / Orange Disinfection or sterilisation in the laboratory suite > yellow/orange clinical waste bags > clinical waste disposal ☐ Infected or potentially infected animal or human body parts, organs or excreta that have been pre-treated before leaving site Yellow Disinfection or sterilisation in the laboratory suite >yellow one way sealed tissue bins > clinical waste disposal (incineration) * Human tissue waste must be placed in separate containers from nonhuman waste and labelled ‘HTA waste’ ☐ Packaging material that has been used for the importation of animal products subject to Defra licences Yellow yellow clinical waste bags > clinical waste disposal (incineration or alternative treatment as described in the licence 8. MAINTENANCE OF CONTROL MEASURES Control measures (e.g. microbial safety cabinets (MSC) / autoclaves) must be maintained and work properly. Simple visual inspection may be appropriate, or more detailed examinations and testing may be needed e.g. MSCs need testing at least every 12 months (or every 6 months for high hazard bio-agents). Specify what, if any, checks on control measures are required and state the frequency of inspection required. Click here to enter text. 9. TRAINING Describe the training that will be given to all those affected (directly or indirectly) by the work activity. Instruction should include the ‘Local Rules’ or ‘Local Codes of Practice’ which focus on the working instructions to be followed by all persons involved in the work activity to control or prevent exposure to hazardous biological agent(s). These should be written and readily available to all workers working at Containment Level 2 or 3. A formal record of training must be kept for all individuals working at Containment Level 3. 9.1 FORMAL TRAINING All workers should attend the training course ‘Biological Agents Safety Awareness’ organized once a term. 9.2 LOCAL TRAINING & SUPERVISION All workers must receive local training BEFORE starting work with hazardous biological agents on the key measures required to prevent or control the risks associated with these hazardous agents (includes important working practices as well as physical features of the containment facility). Key elements of local training provided to workers include: Hazardous nature of the biological hazard(s) associated with the work How exposure could occur Safe working practices to be applied (as described in this risk assessment e.g. safe storage, transport and disposal of materials) Spillage response within the safety cabinet / centrifuge Spillage response elsewhere Post exposure protocols An appropriate level of supervision (based on knowledge and experience of workers) must also be applied to workers before they are allowed to work independently. Page 9 of 12 Version: 1 Confirm that local training will be provided to all workers. This must be documented for all CL3 work and is recommended for all CL2 work. 10. Click here to enter text. EMERGENCY PROCEDURES All questions must be answered and further details supplied when indicated. NOTE that key working practices identified below must be documented in a Code of Practice (CoP) / Local Rules or Standard Operating Procedure (SOP) for CL2 or higher work, or work covered by the Anti-Terrorism (Crime & Security) Act 10.1 Briefly describe the procedures in place for dealing with spillage of infectious or potentially infectious material. Put N/R if not relevant. Click here to enter text. Within the safety cabinet Within the centrifuge Click here to enter text. Within the laboratory but outside of any Click here to enter text. primary control measure e.g. safety cabinet Outside of the laboratory e.g. during Click here to enter text. transportation of material between labs 10.2 Describe the procedures in place for an accidental exposure e.g. inoculation injury or eye splash Immediate action Click here to enter text. When & to whom to report the accident Click here to enter text. 11. ACCESS / SECURITY All questions in this section must be answered for all work at CL2 or higher, or work covered by the AntiTerrorism (Crime and Security) Act. 11.1 Is the lab(s) or other work areas shared with other users not involved in this project Choose an item. If yes, explain who and what procedures are in place to control any risk to them: Click here to enter text. 11.2 What is the containment level(s) of this room(s)? Click here to enter text. 11.3 How is access to the lab(s) restricted e.g. signage, swipe card Click here to enter text. 11.4 Describe the measures in place to ensure secure storage of infectious material Click here to enter text. 12. OCCUPATIONAL HEALTH / HEALTH SURVEILLANCE This section to be completed for work with biological agents or GMMs in Hazard Group 2 or higher and for work with unscreened human tissues ONLY 12.1 Does the work involve Hazard Group 3 biological agents? Choose an item. 12.2 Describe any necessary health surveillance requirements (health surveillance is necessary if organism a) produces an identifiable disease / adverse health effect; b) there is reasonable likelihood that the disease / effect might occur, & c) there are valid techniques for detecting indications of the disease or effect) Click here to enter text. 12.3 Are vaccinations required? If so, which ones? Click here to enter text. 12.4 Persons at special risk? Click here to enter text. Does the nature of this If yes, a health assessment form will need to be completed for all workers, before returning to the Occupational Health Advisor Page 10 of 12 Version: 1 work preclude it being undertaken by any workers who have a serious skin condition (e.g. eczema) or other health problems that might make them more susceptible to infection (e.g. some kind of immunological defect)? 13. CONTAINMENT LEVEL To be completed for all activities Confirm the relevant (COSHH / GM / SAPO) Containment Level requirements for each aspect or component of this project. If different aspects of this work require different Containment Levels, then all must be listed. Note 1: the Containment Level(s) selected represent the minimum containment measures required- other measures, identified in this risk assessment (e.g. use of sealed centrifuge rotor buckets), must also be applied if considered necessary to prevent loss of containment. Note 2: in addition to the containment & control measures set out in the relevant containment tables, the Principles of Good Microbiological Practice must also be applied. 13.1 GM microbial containment Levels (1-4) and associated control measures (GM Regs) Further guidance on GM containment levels Wild type microbial containment Levels (1-4) & associated control measures (COSHH Regs) Further guidance on COSHH containment levels Animal Pathogen containment Levels (1-4) & associated control measures (Specified Animal Pathogens Order) Project aspect Where will work be carried out? Containment Level required under COSHH or GMO (Contained Use) Regs Containment Level required by SAPO (animal pathogens) With derogation from certain controls (list these, if relevant) Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Reduction in (Derogation from) Control Measures: If applicable, justify why specific control measure(s) identified above, normally applied for the selected containment level, is/are considered unnecessary: Click here to enter text. 14. GM CLASS 14.1 Confirm the class of all GMMs in use This section must be completed for work with Genetically Modified Micro-organisms only Consider the GM Class(es) (directly related to the required containment level(s) identified above) for all aspects of the project. Some aspects of this project could be assigned to a lower class (e.g. if the project involves the use of several GMMs some of which are less hazardous than others). The overall project classification will represent the containment level required for the most hazardous GMM to be used. Note 1: if work is assigned to activity class 1, the GMO must present no or negligible risk either to humans or to the environment Note 2: work assigned to activity classes 2 or above must be notified to the HSE (after approval by the University Biological Agents Safety Committee) before work can begin. A notification fee will be payable. Project aspect GM Class Click here to enter text. Click here to enter text. Page 11 of 12 Version: 1 Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. Overall project GM Class (based on highest GM Class required) 15. CONFIDENTIALITY 15.1 All risk assessments are reviewed and approved by the University’s Biological Agents Safety Committee and minutes of these meetings are made widely available to individuals within the University and also on the web. Are there any aspects of this project that you feel should be treated as confidential? If yes, which ones? Click here to enter text. Choose an item. 16. RISK ASSESSMENT REVIEW 16.1 HTTP://WWW.YORK.AC.UK/BIOLOGY/INTRANET/HEALTH-SAFETY/BIOLOGICAL-SAFETY/RISK-ASSESSMENTS2/BIOLOGICAL-RA-REVIEW/ Page 12 of 12 Version: 1