RISK ASSESSMENT FORM FOR AN ACTIVITY INVOLVING ...

RISK ASSESSMENT FORM FOR AN ACTIVITY INVOLVING GENETICALLY MODIFIED PLANTS Notes for Guidance The Risk Assessment Form must be completed and permission received from the GM Safety Committee prior to commencement of any project. A new Form should accompany any grant application which proposes work likely to be covered by the ACGM Regulations. The Form should be completed in typescript. A "Word" template is available from the Health and Safety Advisor (Biological Sciences) (HSA(BS) (David Nelson) who will be happy to answer any queries regarding this Form. You may wish also to consult the University Health and Safety Department Web Site for further information. The GMO Regulations only requires an assessment of risks to human health for GM plants and animals. An assessment of environmental risks however, must also be prepared as a requirement of the EPA 1990 and associated regulations. This form consists of a number of questions which are intended to prompt the assessor to consider the potential environmental and human health hazards of their GM activity and what control measures are needed to reduce the associated risks as low as possible.

Sources of Additional Useful Information The following sources provide additional information which will assist you in the successful completion of your risk assessment. Advisory Committee On Genetic Modification (ACGM) Compendium Of Guidance: http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/index.htm Advisory Committee On Dangerous Pathogens (ACDP) Guidance On The Categorisation Of Biological Agents: http://www.hse.gov.uk/pubns/misc208.pdf HSE GM Information: http://www.hse.gov.uk/biosafety/gmo/information.htm Department of Environment, Food and Rural Affairs (DEFRA) home page: http://www.defra.gov.uk/

1 GM Plant RA: Notes for Guidance (Version 2)

1. Section 1: Status of project General information on the commercial sensitivity of the project and use of GM plant material.

2. Section 2: Background and objectives of GMO project Brief, yet clear outline only please.

3. Section 3: Summary and conclusions of risk assessment

4. What are the main risks to the environment and human health? If none, briefly explain why. Section 4: Details of host / inserted target DNA / genes and vectors Host The host plant species should be named. Vector The vector(s) used should be described. If a commercially available vector, the supplier's information should be attached. Target DNA/Gene The inserted gene(s) should be named.

5. Section 5: Identification of potential harmful effects of the GM Plant to the environment Objective is to determine the probability of harm to the environment arising as a result of escape of GM Plant material from containment. Includes all possible routes of escape including waste disposal. The procedure to follow is summarised below:     

Hazard identification Assessment of likelihood of identified hazards being manifested Assessment of consequences of hazards being manifested Determination of risk (likelihood X consequence) Management (control) of risk

5.1 Hazard Identification Consider the following and identify any potential hazards by comparing the GM plant to the non-modified parent and assume the receiving environment will be exposed. a) The GM plant’s ability to survive, establish, disseminate, compete with and/or displace other plants Compare with non-GM parent. Assess the ability of the GM plant to survive in the environment and the potential for the gene product to persist in the environment and cause harm. Will modification effect the plant’s interactions with the receiving environment? For example, will the GM plant be more invasive / weedy in the natural environment? Will it exhibit altered survival characteristics in the agricultural environment, requiring different management control strategies? 2 GM Plant RA: Notes for Guidance (Version 2)

b) The GM plant’s potential to cause harm to animals Consider, for example, if the GM plant will be toxic to target organisms (such as insect pests) or harmful to non-target species (such as insect predators).

c) The GM plant’s potential to cause harm to beneficial microorganisms Consider, for example, if the GM plant root exudates or the products of plant decomposition have the potential to cause harm. d) The GM plant’s potential to exhibit altered interactions with plant pathogens and the potential for harm that may arise Consider, for example, the possibility of sequences derived from plant viruses being inserted and whether these could combine with secondary infecting viruses to create a novel pathogen? Will the GM plant become a new host for plant pathogens, thereby creating a new reservoir in which they could establish? e) The GM plant’s potential to transfer genetic material to other organisms, thereby conferring any hazards identified in a) – d) on them Consider, for example, the possibility of the GM plant cross pollinating with other plants.

5.2 Assessment of Likelihood Assuming the recommended standard control measures for GM plant activities are applied (Appendix 1 of Risk Assessment), for each hazard identified, express the likelihood of a hazard being manifested as “ high”, “medium”, “low”, or “negligible”, giving justifications. 5.3 Assessment of Consequences For each hazard, describe the consequences to the receiving environment, assuming the receiving environment will be exposed. Express using the terms “severe”, “medium”, “low” or negligible” and give justifications. 5.4 Preliminary determination of risk to the environment For each hazard, identify the level of risk by combining the consequence (assuming exposure) with the likelihood (assuming use of the recommended standard control measures for GM Plants) using the matrix below. This table is a guide for working out the risk associated with a particular operation based on the consequence of the hazard and the likelihood of that hazard happening. Express risk as “high”, “medium”, “low”, or “effectively zero”.

Estimation of Risk Consequence of Hazard

Likelihood of Risk High

Medium

Low

Negligible

Severe

High

High

Medium

Effectively Zero

Medium

High

Medium

Medium/Low

Effectively Zero

Low

Medium/Low

Low

Low

Effectively Zero

Negligible

Effectively Zero

Effectively Zero

Effectively Zero

Effectively Zero

5.5 Containment measures to control the risk to the environment If the preliminary risk assessment in 5.4 is “low” or “ effectively zero”, then standard control measures for GM Plants are appropriate. If the risk is “medium” or “high”, additional measures must be selected and used. Describe the facilities and the containment measures required to control the hazards (e.g. if air filtration is required, specify the filtering efficiency). 3 GM Plant RA: Notes for Guidance (Version 2)

Control Measures for GM Plants Unlike the system for work with GM microorganisms, there is no regulatory requirement to set a formal containment level (i.e. Containment Level 1,2, 3 or 4) for work with GM plants (and animals). As a result, it is necessary to select control measures appropriate to each activity such that the final risk is low or effectively zero. The standard control measures for GM plants, outlined in Appendix 1 of the risk assessment form, represent the minimum level of containment that should be used for GM plants presenting a low or negligible risk, as determined by the risk assessment. The majority of modifications (e.g. with Arabidopsis thaliana) are unlikely to result in a more harmful phenotype, and these measures are considered reasonably practicable to limit contact with both humans and the environment to an acceptably low level. More stringent control measures would be required for work where harm could arise, for example, if the GM plant (including pollen) or its descendants were able to enter the environment.

Final determination of risk to the environment For each hazard, reassess the level of risk assuming that the measures in 5.5 are in place. The control measures should be such that the overall risk is “low” or “effectively zero”.

6. Section 6: Identification of potential harmful effects of the GM Plant to human health 6.1 Hazard Identification Consider the following and identify any potential hazards by comparing the GM plant to the non-modified parent and assume that humans will be exposed. a) The GM plant’s ability to be more toxic to humans than the parent plant b) The GM plant’s potential to be more allergenic to humans than the parent plant c) The GM plant’s potential to exhibit other potential hazards to humans compared to the parent plant 6.2 Assessment of Likelihood Assuming the containment measures in 5.5 above, are in place, express the likelihood of a hazard being manifested as “ high”, “medium”, “low”, or “negligible”, giving justifications. 6.3 Assessment of Consequences For each hazard, describe the consequences, assuming that humans will be exposed. Express using the terms “severe”, “medium”, “low” or negligible” and give justifications. 6.4 Determination of risk to human health For each hazard, identify the level of risk by combining the consequence (assuming exposure) with the likelihood (assuming measures listed in 5.5 are in place) using the above matrix in 5.4. Express risk as “high”, “medium”, “low”, or “effectively zero”. 6.5 Containment measures to control the risk to human health If the risk in 6.4 is “low” or “ effectively zero”, then the containment measures in 5.5 are sufficient. If not, additional containment measures must be used to reduce the risk to risk “low” or “effectively zero”. Describe the proposed facilities and the containment measures and how this impacts on the determination of risk. 6.6 Final determination of risk to human health For each hazard, reassess the level of risk assuming that the measures in 5.5 are in place. The control measures should be such that the overall risk is “low” or “effectively zero”. 4 GM Plant RA: Notes for Guidance (Version 2)

7. Section 7: Waste control measures Prior to final discharge / disposal of waste from contained use activities, any risks to humans and the environment associated with any GMO must be removed by use of validated inactivation methods. Inactivation refers to the complete or partial destruction of GMMs so as to ensure that any contact between the GM plant material and humans or the environment is limited to provide a high level of protection to both humans and the environment. Experimental materials, including soil, should be clearly marked and be treated by a validated means before disposal to kill any residual organisms, such as seeds, tubers etc.

8. Section 8: Notifications Notification to the HSE is only required if the GM Plants have a greater degree to cause harm to humans than the non-modified equivalent.

9. Section 9: Other Legislation A DEFRA licence may be required for some aspects of the work. Where a licence is required, the appropriate containment conditions would be specified on a case by case basis. Inspection of the facility by DEFRA will normally be undertaken before a licence is issued.

10.

Section 10: Supporting References List all references that have been used to support comments made in the risk assessment.

5 GM Plant RA: Notes for Guidance (Version 2)