Safety & Environmental Protection Service

Assessing Risks of Work with Genetically Modified Organisms

Your GM risk assessment should start with the basic information about the project or activity and the principal investigator who is responsible for management of the work. The project title should specify the genetically modified organisms involved and nature of the work. Provide the name of the principal investigator or manager, management unit, date and the location or building where the work will be carried out. You should provide details of the experience, qualifications and training received in genetic modification and the use of genetically modified organisms for all the people who will be doing the work.

Definition of Genetically Modified Organisms

Genetically modified organisms can be microorganisms, animal or plants. GMOCU defines genetically modified organisms as organisms produced by genetic modification. Genetic modification is defined as the altering of the genetic material (DNA or RNA) of an organism in a way that does not occur naturally by mating and or natural recombination or both. Genetically modified organisms can be derived from microorganisms, animals or plants. A microorganism is defined as a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, and includes a virus, a viroid, an animal or plant cell in culture, an artificially created cell into which it is intended genetic material will be introduced and a prion. Organism means any biological entity capable of replication or of transferring genetic material and includes a microorganism but does not include a human, human embryo or human admixed embryo. Contained Use activity is where genetically modified organisms are cultured, stored, transported, destroyed, disposed of, or used in any way, and for which physical, chemical or biological barriers, or any combination are used to limit contact with and provide a high level of protection for humans and environment.

Genetically modified organisms are produced from a combination of a host, vector and genetic material. Genetically modified organisms (GMO) include genetically modified microorganisms (GMM), genetically modified animals (GM animals) and genetically modified plants (GM plants). GMM also includes certain infectious nucleic acids (eg GM infectious virus DNA or RNA) or proteins (GM TSE). There are some exemptions to which the regulations do not apply providing they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms as recipient or parental organisms. Exemptions include radiation or chemical mutagenesis, many natural processes including conjugation, transduction or transformation and polyploidy induction, self cloning and cell fusion, in vitro fertilisation, humans and human embryos

Classification of Genetically Modified Organisms

Genetically modified organisms are classified according to the risks to human health, animals, plants and the environment. GMOCU classifies genetically modified organisms into four activity classes according to these criteria.

• Ability to cause harm or damage.
• Severity of the harm or damage that may result.
• Risk that harm or damage will spread to the population.
• Risk of harm or damage to the environment or economic loss.
• Availability of vaccines and effective treatment.

The four activity classes of genetically modified organisms and the basis of their classification are as follows.

• Activity class 1 (Class 1): Unlikely to cause human disease or have any untoward environmental effects.
• Activity class 2 (Class 2): 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.
• Activity class 3 (Class 3): 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.
• Activity class 4 (Class 4): 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.

Description of the Activity

You should provide a sufficiently detailed description of the work to enable workers, other people and non-experts to understand the exact nature of the work. You need to describe the genetically modified organisms which will be used and to which people or the environment could be exposed in the work and the specific methods involved in the work. You should consider all of the relevant characteristics including the pathogenic, toxic, allergenic, carcinogenic and environmental properties of the hosts, vectors, genetic material and genetically modified organisms.

Host Organism

You should provide details of the host organisms that you intend to use in this project. Host organisms include microorganisms, animals and plants. State the scientific names, strains and provide relevant references.

Vectors

You should provide details of the vector systems that you intend to use on this project. State the names of the vectors and provide relevant references.

Genetic Materials

You should provide details of the origins, nature of modifications and intended function of the genetic materials that you intend to use on this project. Genetic material includes nucleic acid sequences of any kind whether coding or non-coding, whole or part of gene sequences. You should define the types of gene sequences that you intend to use including the designations of specific genes or classes of genes, cDNA, genomic sequences or gene libraries. You should state the intended function of the gene including whether or not you intend to carry out genes expression. It is important to specify whether based on evidence the gene sequences are expected to be harmless genes, harmful genes and undefined genes to humans or the environment. Your work may include one or more potential types of genetic material. It is important to provide relevant references to support statements made about the nature of genetic material.

Genetically Modified Organisms

You need to describe the final genetically modified organisms which are derived from the combination of hosts, vectors and genetic material. You must consider the ways by which harm could be caused to people or the environment from exposure to the genetically modified organisms. The risk assessment and classification procedures required by the GMOCU are complicated and difficult to summarise but depend on the type of activity. You should read and follow the detailed guidance on risk assessments and controls which are given in the HSE SACGM Compendium of guidance. Basically the risk assessment starts with the description of the risks relating to the hosts, vectors, genetic material and then to the final genetically modified organisms. The risks of the genetically modified organisms to human health and the environment are then determined and the activity class assigned. The containment level and control measures which are necessary to protect human health and the environment from exposure to genetically modified organisms must then be established for the work. You should also state if your GM risk assessments are part of a connected programme of work. Different types of GM risk assessments must be carried out for genetically modified microorganisms (GMM), genetically modified animals (GM animals) and genetically modified plants (GM plants).

Risk Evaluation

You have considered the ways by which harm could be caused from exposure to the genetically modified organisms in your work. You will then need to make an assessment of the overall level of risk of harm to human health and the environment from exposure to genetically modified organisms in the work.

Assessment of Risk to Human Health

You need to decide on the level of risk to human health from exposure to genetically modified organisms in this work. Please note that this is the level of risk prior to the use of controls. You will then select the necessary control measures which are required to reduce the level of exposure to the lowest level that is reasonably practicable and in any case to a level which is adequate to protect human health. To help you estimate the level of risk you should use the information below and the risk estimation matrix. This will give you an estimate of the potential risks to human health of the work which will be either effectively zero, low, medium / low, medium or high.

Assessment of Risk to Environment

You need to decide on the level of risk to the animals, plants and other aspects of the environment from exposure to genetically modified organisms in this work. Please note that this is the level of risk prior to the use of controls. You will then select the necessary control measures which are required to reduce the level of exposure to the lowest level that is reasonably practicable and in any case to a level which is adequate to protect the environment. To help you estimate the level of risk you should use the information below and the risk estimation matrix. This will give you an estimate of the potential risks to human health of the work which will be either effectively zero, low, medium / low, medium or high.

Estimating the Risk Level

The risk of the activity is determined by evaluating both the genetically modified organisms and the potential for exposure to them and how they are used in the work. The level of risk of exposure to the hazard is calculated from a combination of the likelihood and consequences of the hazard in the given circumstances.

• Consequences of hazard (severe, modest, minor, negligible).
• Likelihood of hazard (high, medium, low, negligible).

Risk = Likelihood x Consequences = Effectively Zero, Low, Medium / Low, Medium or High.

In practice an estimate of the level of risk can be calculated using a risk estimation matrix.

 

Consequences of Hazard	Likelihood of Hazard
	High	Medium	Low	Negligible
Severe	High	High	Medium	Effectively Zero
Modest	High	Medium	Medium / Low	Effectively Zero
Minor	Medium / Low	Low	Low	Effectively Zero
Negligible	Effectively Zero	Effectively Zero	Effectively Zero	Effectively Zero