果冻影院

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> Before starting work
> Guidance on GMM risk assessments
> Guidance on Class 2 and Class 3听
> Guidance on Living GMO risk assessments
> Guidance on Lentiviral vectors听
> Containment听and storage
> Summary of requirements for approval

Before starting work

A risk assessment is required prior to the use of GMOs. The term 'contained use' is any activity in which GMOs are cultured, stored, transported, destroyed, disposed of or used in any other way and for which physical, chemical or biological barriers are used to limit contact with humans or the environment to ensure a high degree of safety.

果冻影院 typically works under the . However, if GMOs are being released into the environment the听 should be followed. Email biochem@ucl.ac.uk听for more information.

1. Work must not start until your assessment has been reviewed and all appropriate authorisations obtained (including any external approvals from HSE) - you will receive an email notification from riskNET indicating when the assessment has been approved.
2. Check that the area where your work is to be carried out is already听notified to HSE. If not, email biochem@ucl.ac.uk听so that the HSE can be notified. Remember to consider work carried out in听laboratories and Biological Services Units.
3. Carefully consider the scope of your assessment. Where there are a number of activities carried out in contained use that are integrated into a larger programme a 'connected programme听of work ' should be considered. This can avoid over-notification of work.听
4. Check to see if there is already a risk assessment in the system similar to the work proposed.听
5. If a similar risk assessment exists, the risk assessment can be copied and amended as necessary to cover the proposed work.

Copying an existing risk assessment

1. If there is an authorised听risk assessment in place that is similar to the work proposed, the risk assessment can be 'copied' creating a new risk assessment with a new reference number which you can听amend to reflect the new work.
2. If a similar risk assessment does not exist then a new one will need to be created on the relevant template e.g.听Class 1, Class 2, Class 3, GM animals, GM plants. The class of the GMM will be determined by the controls required for the activity involving GMM.
3. Guidance on completing the GM risk assessments can be found in the . There is also specific guidance on risk assessments in the drop-downs: Guidance on听听GMM, Class 2 and 3, GM Animal听risk assessments. Please remember that others (including the HSE) reviewing the assessment may not be familiar with the subject, and may need more information on the nature of the hazards. The following video is a guide on how to create a new risk assessment. Please select the specialist rsk asssesment form e.g. Class1, 2 or 3. The following video听is a guides you through how to create a new risk assessment.听

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riskNET: Risk Assessment of Biological agents and plants听provides guidance on completing and approving biological agent and plant risk assessments, covering genetically modified and wild type work activities.

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1. If you are not sure which assessment forms to use or need help with completing your risk assessment, speak to your local Genetic Modification Safety Officer in the first instance. You can also contact the University听BioChem mailbox听for further help and advice if required.
2. Once the risk assessment is complete select 2 authorisers from your local department. Typically this will be the PI who is in control of the work and the local GMSO. If the Assessor is the PI then a peer with experience and knowledge of the work can review and approve the risk assessment for the technical content. It is the department's responsibility to approve the risk assessment.听
3. Submit the Risk Assessment for authorisation.
4. For Class 2, Class 3, GM animal and GM plant risk assessments there is an additional review completed by the Genetic Modification and Biological Safety Sub Committee (GMBSSC). This is to ensure all the risk assessments have sufficient details of the hazards and controls for the proposed GMO work.
5. Once the GMBSSC are satisfied that the content is sufficient all new class 2 and Class 3 risk assessments will be notified to the HSE see notifications for class 2 and class 3 GMM for further information
6. When the risk assessment has been approved by the Department, GMBSSC and in some cases the HSE work can start.

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听Guidance for GMM risk assessments

All GMM risk assessments should provide an overview of the components of the GMO construct and the activities proposed including the following:

Factors to consider	Information required听
Recipient organism(s)	Give the name of the organism(s) to be used including strain, the name of the wild鈥恡ype organism it is derived from, provide ACDP HG, degree of disablement/attenuation.听Cite evidence.
Vector(s)	List names of vectors and indicate any disabling mutations including the extent to which they can be mobilized (if relevant).听听Cite evidence听听
Inserted genetic material	List names of genes/genetic material to be inserted.听听Describe the function of the inserted material (if unknown, consider likely effects by comparison with homologues if available) and the source of the genetic material e.g., sourced from a wild鈥恡ype organism, generated artificially or altered in anyway before insertion.听听If you are looking at groups/families of genes, list all to be used with a description of the function(s) of the gene family.

Human health and the environment听

Factors to consider听	Information to be provided
The most hazardous GMM to be constructed	Consider hazard impact to human health and the environment. Consider wild types, mutations, likelihood of reversion, over expression, toxic, allergenic, oncogenic effects, tropism, survival, and impact to the environment.听听
Risks to human health	What is the result of an exposure to human health. Survival, severity of response, likelihood of exposure and any uncertainty
Risk to environment	Are the organisms covered by additional legislation, infection and colonisation. Could the GMM be an adventitious agent.

For Class 2 and 3听GM risk assessments the above information will be required plus more comprehensive information as described in the table below:

Health hazards

Hazards of:	Information required听
The recipient organism	ACDP HG of the wild type, mode of transmission, disease symptoms, tissue tropism. Availability of vaccines or therapeutics treatments
Alterations	Pathogenicity, adhesion / penetration factors or surface components (receptors, envelope protein, capsids) providing resistance to immune system or therapeutic drugs.
Inserts 听and or knockouts	Toxin, oncogene, allergen, modulation of growth-hormone /cytokine and听听hazards of over expression.
Transfer	Impact of dissemination, survival in the environment allowing for gene transfer.
More or less hazardous	Is the construct more hazardous than the wild type or less hazardous? Start with the wild type containment measures then determine if additional controls from the Containment level above are required or has the organism been altered in such a way that it can handled with lower controls. Consider the GMO as well as the activity proposed.

Environmental hazards

Hazards of:	Information required
The recipient organism	Capability to infect plants, animals, and insects. Can alterations be reverted to wild type. Are the microorganisms included in other legislation e.g., SAPO or Anti-terrorism, crime and security Act, Schedule 5
Inserts and or knockouts	Impact on pathogenicity, resistance to therapeutic drugs, or ability to evade host natural defences, are the inserts / knock outs toxins, cytokines or oncogenes
Hazards from transfer	Impact of widespread dissemination, survival in the environment allowing gene transfer

Activity hazards

Hazards of:	Information required
Aerosol generating activities	How will these be managed e.g. MSC / centrifuge buckets / rotors with lids
Waste management	Specify disinfect procedures, autoclave procedures and back up plans
Sharps	How will sharps be managed
In vivo work	Detail the risks of shedding
Life cycle of the organisms	Is there a hazardous part of the life cycle e.g., parasites where there is an infective stage or release of spores from fungi
Are there high-risk users	e.g., people who have existing skin conditions e.g., eczema. Immunocompromised or immune suppressed workers
Health surveillance requirements	Available vaccinations and or health surveillance requirements.
Control measures	What additional controls are required above those available at the containment level identified. If some activities assigned to different classes, please provide more information on these.

Guidance for Living Genetically Modified Organisms听risk assessment

The table below provides guidance on the information required for an GM Animal and GM plant听risk assessment.

Factors to consider	Information required
Risks to the environment if animals escape	Stability of modification allowing Survival 鈥� temperature, food sources, Establishment - out competing, displace or prey on native species, impact on food sources for wild animals Disseminate genetic modification through breed with wild animals or shedding. Consider selection pressure to revert to wild type
Transfer of genetic material	Sexually compatible species, sex and fertility of animals. Female animals are a lower risk to the environment providing they can be retrieved before breeding
Insert	Does the insert code for any biologically active substances Does the insert make the animal a disease reservoir e.g., able to express a receptor for virus, or toxin
Characteristics of the proposed activity	Detail the proposed activities and the associated risks to human health and the environment
Likelihood of adverse effects to human health and the environment	How are the animals restricted from accessing the external environment, ease of escape, ease of retrieval of escapees.
Consequence of adverse effects to human health and the environment	Impact of genetically modified material entering the environment
Containment measures	Containment and control measures for GM animals Appropriate size pens / cages / enclosures for the species. There should be physical barriers to prevent escape in addition to the procedure and management controls.

Only those activities where the LGMO is more harmful than the parental organism need to be notified to HSE. Work can start 45 days after the date of the acknowledgement or earlier if HSE gives written approval for the work to start.

For further information refer to .

Notifications for Class 2 and Class 3 GMM

All new Class 2 and Class 3 GM work must be notified to the Health and Safety Executive (HSE) (Class 2 and above).

The notification process requires a 果冻影院 GM risk assessment in the correct template. After the GMBSSC is satisfied the information in the GM risk assessment is sufficient, an will need to be completed. The word format will be sent out by Safety Services who will assist in submitting HSE notifications. The information on the CU 2 form听will appear on the public register.

The HSE also require a payment for notifications. Safety services will request your PTA (Project.Task.Award) codes once you have submitted all the relevant paperwork. Information on All notifications to HSE are made via the听Safety Services.

Send your CU2 by email to Safety Services - this will then be filed with your assessment on riskNET once we have received either the acknowledgement or consent from HSE.

When can work start?

Class 2听-听All new and subsequent Class 2 activities must be notified to HSE.听 As 果冻影院 already has Class 2 activities notified to HSE, work may start on receipt of the acknowledgement from HSE unless they indicate that work should not start.听 You should receive an acknowledgement within 10 (working) days of receipt of the notification by HSE. This will be filed as an attachment with your assessment in RiskNET

Class 3听- Work may not start without written consent from HSE.听 This will be granted (or refused) within 90 days of the date of the acknowledgement for the first notification of this activity class, and 45 days for subsequent activities.

Work with transgenic plants or animals听- Only those activities where the GMO is more harmful than the parental organism need to be notified to HSE.听 Work can start 45 days after the date of the acknowledgement or earlier if HSE听gives written approval for the work to start

Class 1 risk assessment approval process听

Class 2 and 3 risk assessment approval process听

Guidance on Lentiviral vectors听

Class 1 or Class 2?

When classifying any GMO the default is to handle as the wildtype. Then consider if the wild type microorganism has been made more hazardous or less hazardous. This will be determined by the final construct with the inserts and or knock outs. Then the activities involving the GMO have to be considered to determine the final class of the GMO.

The table below provides guidance on when lentiviral vectors can be Class 1 and Class 2.

Class 1 Activity听 not notifiable to the HSE听	Third generation or above Contains a Self Inactivating LTR No harmful inserts No sharps听
Class 2 Activity听 notification and a fee required by the HSE	Use of first or second generation vector听 Include harmful inserts such as cytokines, toxins, oncogenes, growth factors and immunomodulatory proteins. Use of WPRE which codes of protein X Use of sharps

For听work to be considered to be class 1 all the criteria listed above must be met. However, for a lentiviral vector to be Class 2 it only needs to meet one criterion listed above or require a single or multiple CL2 controls. The information above听should be considered when determining the class of the GM work involving Lentiviral vectors.听This will be determined by risk assessment on a case-by-case basis.

The GM risk assessment should also document management and controls when using sharps and aerosol generating activities.

Further information about Lentiviral vectors including information on the generations of Lentiviral vectors can be found in the . For further information contact your local GMSO or the Biochem mailbox.

Containment

The containment level is usually based on the hazard group, however, the type of work you are doing may change the containment level required. This should have been assessed during the risk assessment process.

All containment labs and equipment such as microbiological cabinets听will require additional department lead training before work can begin.

> Containment Levels
> Storage of GMM听

Summary of requirements for approval听

Risk assessments must not be written and approved by the same person.听

GM risk assessments should be approved by the person in management control of the work, for example, the Principal听Investigator. If the PI is the assessor and needs to be listed as an approver, then a peer with knowledge and experience of GM听work, such as the local Genetic Modification Safety Officer (GMSO),听can approve the risk assessment to confirm the technical detail and the controls to be implemented are听suitable

Additional approval听for Class 2 and Class 3 Geneticaly Modified听material

Once the approvers listed in the GM risk assessment have approved the risk assessment, approval is also required by the GMBSCC before the risk assessment is sent to the HSE for notification for new work or significant changes. Minor amendments Class 2 and Class 3 GM risk assessments that have been notified and agreed by the HSE can be approved by the 果冻影院 GMBSSC and will not require further notification unless the scope or the risk has changed.听

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