1. Safety Service 5A Lennoxvale Working Safely with Genetically Modified Organisms

2. Legislation ‘The Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001’ Other legislation may ALSO apply if working with plant or animal pathogens: the Plant Health (Great Britain) Order 1993 (as amended) The Specified Animal Pathogens Order (Northern Ireland) 2008

3. What do “The Contained Use Regulations” say? You must protect: human health and safety and the environment from activities involving genetically modified micro-organisms (including animal and plant cultures) human health and safety from GM animals and plants

4. Some GM Definitions Contained use An activity in which organisms are genetically modified or in which genetically modified organisms are cultured, stored, transported. Where physical, chemical or biological barriers, are used to provide a high level of protection for humans and the environment. Microorganism A micro-organism is capable of replication or of transferring genetic material, and includes a virus, viroid, and an animal or plant cell in culture Organism A biological entity capable of replication or of transferring genetic material and includes a micro-organism, but does not include a human or a human embryo Genetic modification “… the altering of the genetic material in an organism in a way that does not occur naturally by mating or natural recombination or both …” Important Note - Having (on the premises) a GMM or a GMO that has been genetically modified constitutes “use” under these regulations.

5. Is it genetically modified or not? YESNO Recombinant nucleic acid techniques involving the formation of new combinations of genetic material - this involves the insertion of nucleic acid, produced outside an organism, into any virus, bacterial plasmid or other vector and then the incorporation into a host organism in which they do not occur naturally but in which they are capable of continued propagation. Techniques involving the direct introduction into an organism of heritable genetic material prepared outside the organism - micro-injection - macro-injection - micro-encapsulation

6. GM or NOT? Cell fusion or hybridization techniques Where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally. Key point in defining GM Any technique which alters the genetic material of an organism using a method that would not occur by natural mating or recombination. Also gene deletions or insertion of multiple copies of a gene are GM if brought about by artificial means.

7. GM or NOT? Techniques which are NOT considered to be Genetic Modification: in vitro fertilisation natural processes including conjugation, transduction or transformation polyploidy induction (providing they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms)

8. GM or NOT? More Techniques which are NOT considered to be Genetic Modification: Mutagenesis Cell fusion of prokaryotic species which can exchange genetic material through homologous recombination Cell fusion of cells of any eukaryotic species, including production of hybridomas and plant cell fusions (providing they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms)

9. Duties under the Contained Use Regulations Before any GM work is started in an institution you need to: 1. Notify premises to HSENI 2. Become a registered GM Centre 3. All individual buildings used must be detailed 4. Establish a Genetic Modification Safety Committee (GMSC)

10. When completing your GM Risk Assessment: 1. Assess risks to human health and safety and the environment. 2. Taking into account Schedule 3 or 4 of the Contained Use Regulations i.e. any harmful effects. 3. Select appropriate containment and control measures. N.B. Please complete the GM Risk Assessment and NOT the BioCOSHH Risk Assessment

11. Classification of Genetically Modified Organisms Genetically modified organisms are classified according to the risks to human health, animals, plants and the environment. The GMO Contained Use Regulations classify genetically modified organisms into four activity classes according to the following criteria: 1. Ability to cause harm or damage. 2. Severity of the harm or damage that may result. 3. Risk that harm or damage will spread to the population. 4. Risk of harm or damage to the environment or economic loss. 5. Availability of vaccines and effective treatment.

12. The four activity classes of GMOs Class I: Unlikely to cause human disease or have any untoward environmental effects. Class II: May cause human disease or be a hazard to employees but it is unlikely to spread to the community and there is usually effective prophylaxis or effective treatment available. Unlikely to cause significant environmental damage. Class III: May cause severe human disease and presents a serious hazard to employees and it may present a risk of spreading to the community but there is usually effective prophylaxis or treatment available. Possibility of significant environmental damage, or economic loss if accidentally released. Class IV: May cause severe human disease and presents a serious hazard to employees and it is likely to spread to the community and there is usually no effective prophylaxis or treatment available. Likely to cause severe environmental damage or economic loss if accidentally released.

13. Route of Approval All GM projects at Queens University have to be approved by the BIACC GM Sub–Group (through Dr D. Norwood in the first instance) The following Flowchart details all the procedures necessary in Queen’s University before GM and Infectious Agents work can be undertaken:

15. To summarise: GMO Class I Approval Procedures: 1. Start the authorisation process by informing your Supervisor, PI, CD or HoS as appropriate. 2. Inform your local Biological Safety Officer and H&S Committee. 3. Complete your GMO Risk Assessment and send to the University Biological Safety Officer (Dr D. Norwood). 4. The University Biological Safety Officer sends your GMO Risk Assessment to each member of the BIACC GM Sub–Group who comment on your risk assessment. 5. The University Biological Safety Officer contacts you regarding any improvements or not which may be necessary – and finally giving approval for the project to proceed.

16. GMO Class II and Class III Approval Procedures: 1. Start the authorisation process by informing your Supervisor, PI, CD or HoS as appropriate. 2. Inform your local Biological Safety Officer and H&S Committee. 3. Complete your GMO Risk Assessment and send to the University Biological Safety Officer (Dr D. Norwood). 4. The University Biological Safety Officer sends your GMO Risk Assessment to each member of the BIACC GM Sub– Group who comment on the robustness of your risk assessment. 5. The University Biological Safety Officer contacts you regarding any improvements or not which may be necessary – and finally giving approval for the project to proceed. (The same as GMO Class I) PLUS 6. If BIAAC approved then the University Biological Safety Officer submits the following to the HSENI: a) Premises (Form CU1 if never completed before ) b) Activity Notification (Form CU2) c) Risk Assessment d) Fee 7. If this is the first Class 2 Activity Notification, activity may start when consent received (within 45 days for CLII and 90 days for CLIII). Subsequent activity may begin immediately after notification is acknowledged from HSENI for CLII and within 45 days for CLIII.

17. And FINALLY Please note that these procedures must be strictly adhered to as contravention of “The Genetically Modified Organisms (Contained Use) Regulations” may result in disciplinary procedures or even Criminal charges. If you have any questions about the Health & Safety of working with GMOs or the procedures involved contact the University Biological Safety Officer Dr David Norwood: Email: d.norwood@qub.ac.uk Phone: 02890 974610d.norwood@qub.ac.uk

18. Information and Reference documents This presentation was prepared using the following references: 1. The Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001 2. Guidance from the Scientific Advisory Committee on Genetic Modification 3. Safety Requirements for Work involving Genetic Modification (Dr C. Perrons University of Edinburgh)