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Why CHAS?CHAS is a pre-qualification scheme that allows local authorities and other organisations to determine that you have the minimum standard required under the Scheme.CHAS AccreditationThe thresholds for achieving CHAS compliance are applied by a certified CHAS assessor, according to their legal or best practice standard.
Our Risk Assessment Training Presentation gives you the tools to make creating risk assessments as simple as possible. It is noted that this module does not replace Annex III, but it aims to assist risk assessors in the practical use of the concepts contained therein. Although many of the principles included in this module are applicable to a wide range of LMOs, this module focuses primarily on risk assessment of LM plants produced through the application of in vitro nucleic acid techniques, due to the experience available. Risk assessments are intended to calculate or estimate the risk to a given target organism, system, or (sub)population, including the identification of uncertainties, following exposure to a particular agent, taking into account the inherent characteristics of the agent of concern as well as the characteristics of the specific target system (WHO, 2004). The objective of a risk assessment under the Cartagena Protocol “is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health” (Annex III). The results of risk assessments of living modified organisms (LMOs) are typically used by decision-makers to make informed decisions regarding the approval, with or without conditions (e.g.
In order to understand what is meant by risk assessment it is important to be familiar with the concepts of risk and hazard, and how these terms differ.
The exposure pathway from the hazard to the receptor and the possible exposure scenarios 2 form important additional elements in understanding risk. Risk: the combination of the magnitude of the consequences of a hazard, if it occurs, and the likelihood that the consequences will occur. Risk assessment: the measures to estimate what harm might be caused, how likely it would be to occur and the scale of the estimated damage. If risks are identified during the risk characterization step above, risk management strategies may be identified which may effectively prevent, control or mitigate the consequences of the adverse effects. It is worth noting, however, that it is only during the decision-making process that a choice is made as to whether an identified risk is acceptable and whether or not risk management strategies are to be implemented (see more details on the identification of risk management strategies under step 5). As a whole the risk assessment process can be highly iterative; meaning that one or several steps may need to be re-evaluated when, for instance, new information becomes available in an attempt to increase the level of certainty. Familiarity with the different terms used in risk assessment enables a more direct comparison between the terminology used in Annex III and different risk assessment frameworks. Risk assessors need to identify the information needed to conduct a risk assessment and understand how it will be used. Considerations of the quality and relevance of information available for the risk assessment are important throughout the risk assessment process.
Scientifically sound methodologies should be determined and documented for testing any identified risk scenario.
Uncertainty is an inherent and integral element of scientific analysis, and its consideration is undertaken throughout the whole risk assessment process. Although uncertainty may, in some cases, be addressed by requesting additional information, the necessary information may not always be available or new uncertainties may arise as a result of the provision of additional experimental data.
Uncertainties may arise from: (i) lack of information, (ii) incomplete knowledge, and (iii) biological or experimental variability, for example, due to inherent heterogeneity in the population being studied or to variations in the analytical assays. It is important to note that while scientific uncertainty is considered during the risk assessment process and the results of uncertainty considerations may be reported it is, ultimately, the responsibility of the decision-makers to decide how to use the information in conjunction with the principals of the precautionary approach when making a decision on an LMO. When the regulatory process of a country triggers the need for a risk assessment, it usually results in a request from the competent authority to the risk assessor(s). In practice, if a risk assessor is faced with a request by the Competent National Authorities (CNA) to conduct or review a risk assessment that does not follow the case-by-case principle, the risk assessor recommends to the CNA that a new risk assessment be carried out with a scope that is specific to the case under consideration (i.e. Protection goals for the conservation and sustainable use of biodiversity, may be defined in national, regional and international policies. After consideration of the protection goals, the risk assessment of a particular LMO proceeds to establishing the scope in order to define the extent and the limits of the risk assessment process.
Although these actions are described here as separate activities, in practical terms, this is an iterative process where the risk assessors will usually draw on the results of each action to inform the subsequent actions until all their elements have been considered sufficiently enough to enable the risk assessment to proceed. The purpose of an assessment endpoint or of representative species is to provide a measure that will indicate whether or not the LMO may cause an adverse impact on a protection goal.
Assessment endpoints or species representative of important ecological functions 4 or roles should be selected on a case-by-case basis.
Identifying assessment endpoints or representative species that are relevant within the context of the likely potential receiving environment allows the risk assessor(s) to focus on interactions that are likely to occur. In practice, if relevant assessment endpoints or representative species are selected, the baseline data will consist of data that establishes the conditions of these endpoints or species before the introduction of the LMO in question.
As seen above, a comparative approach is one of the general principles of risk assessment as set out in Annex III to the Protocol, where risks associated with the LMO “should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment”. Conducting the risk assessment involves synthesizing what is known about the LMO, its intended use and the likely potential receiving environment to establish the likelihood and consequences of potential adverse effects to biodiversity, taking into account human health, that result from the introduction of an LMO.
Neither the Protocol nor this Manual makes a distinction between the various types of introductions into the environment, such as releases for experimental purposes or releases for commercial purposes. The following sections will address the steps of the risk assessment methodology described in paragraph 8 of Annex III to the Protocol. The first step of the risk assessment is “an identification of any novel genotypic and phenotypic characteristics associated with the LMO that may have adverse effects on biological diversity in the likely potential receiving environment, taking into account risks to human health”. What constitutes an “adverse effect” (also referred to as “damage” or “harm”) will depend on the context and scope of the risk assessment taking into account, as appropriate, the specific protection goals as seen above. Example 16 – Potential adverse effects “Harm adverse effect reflects an undesirable condition involving damage or injury.
Example 17 – Potential risks With every new emerging technology, there are potential risks. The genotypic and phenotypic characterization of an LMO provides the basis for identifying differences, both intended and unintended, between the LMO and its recipient or parental organism(s). Other phenotypic data are often presented to indicate that the LMO is behaving as anticipated.
Once the potential adverse effects have been identified, the risk assessment proceeds to estimating the likelihood and consequences of these effects.
A risk scenario may be defined as a sequence of events with an associated probability and consequence.
A well-defined risk scenario should be scientifically plausible and allow the assessor to identify information that is necessary for the assessment of risks.
A common challenge in generating a well-defined risk scenario is to choose representative species that would be exposed to the LMO. Gene flow followed by introgression of the transgene in species of interest – “Gene flow” is the transfer of genetic material from one organism to another by vertical or horizontal gene transfer; 8 or the movement of an organism from one environment to another. Gene flow followed by introgression from an LMO to non-modified organisms may or may not be considered an adverse effect depending on the protection goals.
The potential for gene flow is first evaluated by investigating if sexually compatible species are present in the likely potential receiving environment. Toxicity to non-target organisms – The potential for an introduced gene product to be toxic to organisms in the environment is typically addressed by controlled exposure in the environment or by direct toxicity testing, or by a combination of the two. The gene products of the modified genetic elements in LMOs may be produced in very small quantities thus may be difficult to isolate in the amounts required for toxicity testing. Allergenicity – Allergies are a type of adverse immunological response that affect individuals who are predisposed to certain types of substances (i.e.
In considering allergenicity caused by LMOs, it is important to take into account the exposure to proteins newly expressed by the LMO, including some variants of these proteins (e.g. It is also possible that allergens known to exist in the recipient or parental organism(s) are produced in higher amounts, for example by over-expression of the gene that encodes a protein that is known to be a common allergen. Multi-trophic interactions and indirect effects – “Multi-trophic interactions” involve more than two trophic levels in a food web. An important feature of non-target effects is that they can involve knock-on food-web effects, such as effects on predators and parasitoids that are exposed to the transgenic product through their prey or hosts that feed on the GM crop (known as tritrophic exposure), or more complicated linkages. Observations and experimentation to identify such effects are challenging because of the complexity of ecological interactions, the difficulty of establishing causality between observed variation and treatment effects (e.g. Resistance development – The extensive use of herbicides and insect resistant LM crops has the potential to result in the emergence of resistant weeds and insects. The extent of the adverse effect and possible consequences of the insurgence of resistant weeds and insects should be thoroughly considered in a risk assessment.
The information required for each of these elements in a risk assessment may vary in nature and level of detail from case to case. A large portion of the information listed here is usually included in the LMO request triggering the risk assessment. Example 22 – The case-by-case approach “A risk assessment performed for a particular LMO intended to be introduced to one environment may not be sufficient when assessing the possible adverse effects that may arise if that LMO is to be released under different environmental conditions, or into different receiving environments. In order to identify whether or not the LMO possesses characteristics that may cause potential adverse effects (see above), it is first necessary to have information about the non-modified recipient organism (or parental organisms).
For many LMOs, the biology of the recipient organism will strongly influence the potential interactions of the LMO in the receiving environment.
The information that is needed for the characterization of the recipient organism will vary depending on each case.


For many species of LMOs, information on the recipient organism can be found in biology documents, such as those published by the Organization for Economic Co-operation and Development (OECD) 9 and the Canadian Food Inspection Agency (CFIA).
The LMO will, in most cases, share most of its genetic characteristics with its actual recipient organism (i.e. Taxonomic status – This information is useful for identifying the recipient organism and ensuring that information provided and cited during the assessment pertains to the organism for which the assessment is being carried out. Common name – The familiar or colloquial names for the recipient organism that may be commonly used in the country of introduction and in international trade may be useful for finding information relevant to the biology of the organism. Biological characteristics – Information on the biological characteristics of the recipient organism, such as the production of endogenous toxins and allergens, its reproductive biology, dispersal of seeds and vegetative propagules, and growth habits, are also important points for consideration. Centres of origin and centres of genetic diversity – Knowledge of the centre(s) of origin and genetic diversity can provide information on the presence of sexually compatible species and the likelihood of ecological interactions in the receiving environment. Habitat where the recipient or parental organism(s) may persist or proliferate – Information about the ecosystems and habitats (e.g. Information on the genetic material that was introduced or modified, as well as the method used for the genetic transformation is useful in identifying novel properties of the LMO such as, what new gene products are expressed and which of the endogenous genes of the recipient or parental organism(s) may be affected by the genetic modification. Donor organism(s) – The relevant information on the donor organism(s) includes its taxonomic status, common name, origin and relevant biological characteristics. Modified genetic elements – The relevant information on the modified genetic elements encompasses the name, sequence, function and other characteristics of all the nucleic acid sequences that were inserted, deleted or modified in the LMO.
Vector – In molecular biology, a vector is a nucleic acid molecule used as a vehicle to transfer foreign genetic material into a cell. Characteristics of the modification – This refers to information about whether or not the inserted or modified genetic elements are present and functioning as expected in the LMO. Unique identifiers – A Unique identifier is a code provided by the LMO developer to a transformation event 11 derived from recombinant DNA techniques to enable its unequivocal identification. Detection and identification methods – The availability of methods for detection and identification of the LMO may be considered as well as their specificity, sensitivity and reliability. The Biosafety Clearing-House of the Cartagena Protocol maintains an LMO registry 12 containing, amongst other things, information on unique identifiers, molecular characteristics and available detection methods for the LMOs addressed in countries’ decisions. Procedural clarity -The method must be complete and laid out in a step wise fashion that may be easily followed by a person unfamiliar with the method. Reference material - The company must provide appropriate reference materials to the CFIA upon request. Contact information - The company must provide contact information for a technical support person. For the majority of us, risk is something we come into contact with on a daily basis whilst at home and work. Did you know that if your job is deemed more at risk than others, you are legally required to be appropriately trained?
Here at Aspex Training we offer accredited Risk Assessment Training to companies and establishments for your employees who require training in this area. The level your company must achieve to become compliant will differ depending on a number of factors. It takes you through your legal requirements and explains the process of completing risk assessments. Any methodology or terminology that is used in this module but not included in Annex III or in the Protocol does not reflect a particular regulatory approach to risk assessment of LMOs, but rather draws from a variety of academic and regulatory experiences.
In the context of biosafety, risk assessment can be defined as the process of estimating risks that may be associated with an LMO on the basis of what adverse effects may be caused, how likely the adverse effects are to occur, and the consequences should they occur. The term “risk” does not have a single unambiguous definition but it is often defined as “the probability of harm”. Ascribing the probability and consequences of exposure of a receptor to the hazard characterizes the risk. As such, the risk assessment process often includes an additional step to identify a range of possible risk management strategies that could reduce the level of risk. At a conceptual level, the methodologies have been adapted from the existing paradigms for environmental risk assessment developed for chemicals and other types of environmental stressors (Hill, 2005).
It will also facilitate the interpretation of results from different risk assessments, for instance, for the same LMO. Using and interpreting existing information, as well as identifying information gaps and understanding how to deal with scientific uncertainty are important factors during the risk assessment.
Relevant information may be derived from a variety of sources such as existing scientific literature, experience and outcomes from previous risk assessments, in particular for the same or similar LMOs introduced in similar receiving environments, as well as new experimental data such as laboratory experiments (e.g. When assessment methods are well described, risk assessors and subsequent reviewers are better equipped to determine whether the information used was adequate and sufficient for characterizing the risk.
The golden rule during the risk assessment of an LMO is to request additional information that is relevant to the overall evaluation of risk and will facilitate the decision making. This request includes the scope of the risk assessment to be carried out as well as some important elements that will set the context of the risk assessment. In setting the context of a risk assessment, these goals may be relevant to the identification and selection of appropriate assessment endpoints and to determining which methodology will be used in the risk assessment process.
In order to be useful, the selected assessment endpoints or characteristics of the representative species should be specific and measureable. The complexity of ecosystems and the large number of potential candidates add to the challenges in selecting the appropriate assessment endpoints in ecological systems.
Moreover, risk scenarios may be also formulated to include assessment endpoints or representative species that are not present in the likely potential receiving environment but may, nevertheless, be indirectly exposed to the LMOs. This may happen, for example, in the case of LM crops that are tolerant to abiotic stress if the non-modified recipient or parental organisms are not capable of growing in the receiving environment. However, the nature and level of detail of the information needed to conduct the risk assessment will vary depending on the intended use of the LMO (e.g.
These steps describe a structured and integrated process whereby the results of one step are relevant to subsequent steps.
This includes change in the morphology, physiology, growth, development, reproduction or life span of an organism or group of organisms that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences.
Molecular analyses may be performed to characterize the products of the modified genetic elements, as well as of other genes that may have been affected by the modification. This could include data on reproductive characteristics, alterations in susceptibility to pests and diseases or tolerance to abiotic stressors, etc. In the context of risk assessment of LMOs, a risk scenario may be explained as a scientifically supportable chain of events through which the LMO might have an adverse effect on an assessment endpoint.
This is why an exposure assessment should be considered when selecting assessment endpoints.
In the case of plants, vertical gene flow may occur even between organisms that are located far apart since pollen can be carried across large distances by the wind or insects, for instance. If sexually compatible species are present, there is a possibility of gene flow from the LMO to these species. Early tier studies involve highly controlled laboratory environments where representative or surrogate test species are exposed to high concentrations of the gene product being studied (i.e. If this is the case, and it is determined that toxicity tests are required, the risk assessor may consider results from tests using gene products obtained from alternate (surrogate) sources (e.g.
They are an important concept in ecology and occur when a change at one trophic level indirectly affects trophic levels which are more than one step away. If the prey or host are unaffected by the transgenic product themselves, they may expose their predators or parasitoids over a prolonged period of crop growth, and they may also concentrate the transgenic protein in their bodies to levels higher than those found in the plant tissues.
Some regulatory frameworks require that risk management strategies are identified in order lower the risk of resistance development. In order to identify and assess risks, each of these elements needs to be characterized in a concerted manner and as appropriate for the specific risk assessment. The following sections provide examples of information that may be relevant for the characterization of each element above. The risk assessors can determine whether or not the information provided is sufficient and adequate for conducting a scientifically sound risk assessment. A risk assessment performed for a particular use of a particular LMO may not be sufficient when assessing the possible adverse effects that may arise if that LMO is to be used in different ways.
Information on the recipient organism is therefore essential as it will help the risk assessor identify the exposure, its scenarios and, ultimately, if any risk is posed by an LMO.
For example, the nature and detail of information about the recipient organism that is required may differ between small-scale releases for experimental purposes and large-scale commercial releases. Caution is recommended when using information about recipient organism when only common names (versus the scientific name) are used because the same common name can be applied to more than one species.
In the absence of more specific information, the centre of origin can also offer insight into the biology of the species (e.g. These include not only the target gene(s) but also, for example, all marker genes, regulatory sequences, and any non-coding DNA. If a vector, for example a plasmid, was used for the transformation, relevant information includes its identity, source or origin, and its host range.
Agrobacterium mediated, particle gun, etc.) is also relevant when describing the genetic modification.


Normally this involves confirmation that the DNA insert or modified genetic element is stable in the genome of the LMO.
Each unique identifier is made up of a sequence of 9 alphanumeric digits, for example MON-89788-1, assigned according to the OECD guidance document (OECD, 2006). This information may be relevant not only for assessing risks but also when considering possible monitoring and risk management strategies (see step 5 below).
Appropriate reference material will be determined by the CFIA based on the method provided. The first section provides an overview of the general methodology for environmental risk assessment and reviews some of the terms used. As in the other modules, examples from various approaches to risk assessment are provided in the boxes. This module provides an introduction to risk assessment and considerations that may assist risk assessors in conducting risk assessments of LMOs that are consistent with Article 15 and Annex III of the Protocol 1.
This is broadly understood as the likelihood that a harmful consequence will occur as the result of an action or condition. In the risk assessment of LMOs, “exposure” can be understood as the route and level of contact between the likely potential receiving environment and the LMO or its products.
All these elements must be evaluated to form an effective and useful risk assessment for specific scenarios (UNEP Division of Technology, Industry and Economics). The same acid is a risk to human health only if humans are exposed to it without protection. Thus, it is important to consider and analyze, in a systematic way, the various forms of uncertainty (e.g. In a typical case-by-case scenario, in accordance with the Cartagena Protocol, these elements will include at a minimum: the LMO(s), its(their) specific use(s) and, in cases of introduction into the environment, the likely potential receiving environment(s) where the LMO may be released and establish itself.
Understanding the contribution of national, regional and regulatory policies in setting the context of the risk assessment is part of the preparatory work for a risk assessment as seen in Module 2. This could occur, for example, if a third species, which is sexually compatible with the LMO and the representative species, has a distribution area that overlaps with the distribution areas of the former two providing an indirect exposure pathway between them. Baselines can refer to, for instance, a particular environment or health conditions of a population.
However, (near-)isogenic lines are not always available and the choice of appropriate comparators may be guided by policies or guidelines adopted by the country undertaking the risk assessment (e.g. In extreme situations, when a suitable comparator cannot be grown under the same conditions and in the same or similar receiving environment as the LMO, it may be necessary to treat the LMO as a novel species in that environment (i.e. Additionally, the risk assessment process may need to be conducted in an iterative manner, whereby certain steps may be repeated or re-examined to increase or re-evaluate the reliability of the risk assessment. Data on specific expression patterns may be relevant for risk assessment in order to determine exposure, and may also include data confirming the absence of gene products, such as RNA and proteins, different from those originally intended. Clear and well-defined risk scenarios can also contribute to the transparency of a risk assessment because they allow others to consider whether or not the subsequent steps of the risk assessment have been adequately performed and facilitate the consideration of possible strategies to manage the identified risks. Whether or not the modified genetic elements can potentially introgress into the population of the sexually compatible species will be largely determined by the biology of the recipient organism and of the LMO itself (see considerations regarding the likelihood and consequences of gene flow and introgression in steps 2 and 3). As a consequence, some allergenicity studies must be carried out with proteins isolated from the LMO itself, and not obtained from an alternate (surrogate) source such as a bacterial expression system. Consideration of tri-trophic interactions and indirect effects may be relevant to biodiversity protection goals. Moreover, in a food chain (or food web), effects at the trophic levels may become observable only at a later stage. Several weed species have developed resistance to specific herbicides which are extensively used in combination with herbicide-resistant LM crops.
Moreover, it is important to note that while these three elements may be sufficient to establish the boundaries of a risk assessment, potential adverse effects may extend past these elements, for instance, beyond the likely potential receiving environment and the intended use(s) of the LMO. These sections include several of the “points to consider” as indicated in paragraph 9 of Annex III of the Protocol. If needed, they can obtain additional information by, for instance, carrying out their own investigation or requesting it from the applicant. It normally includes the biological and reproductive characteristics of the recipient organism that can be important for determining the potential exposure of other organisms, such as predators, prey, competitors or pathogens, to the LMO in question in the likely potential receiving environment. Thus, it is also important to consider, whenever possible, comparative data from the actual non-modified recipient organism (see the section on “The choice of comparators”).
This allows the risk assessors to understand the range of habitats in which the species exists, the range of behaviours exhibited in those habitats, and how characteristics of the species determine the range of habitats where it can persist or proliferate. If available, a history of use may be important with regards to potential toxicity or allergenicity of the gene products derived from the donor organism.
Depending on the transformation method, parts of the vector(s) may also be incorporated into the genome of the newly developed LMO.
Information such as the insertion site in the genome of the recipient or parental organism(s), cellular location of the insert (e.g. Some regulatory frameworks require a description of such methods as a condition for regulatory approval in order to ensure the tools to assist with monitoring and risk management are available. The second section elaborates on issues that are overarching to the entire risk assessment process, such as the quality and relevance of information needed and considerations of uncertainty. Thus, the degree of harm caused by the exposure will depend on the specific exposure scenario. The relevance and level of detail of the information needed may vary from case to case depending on the nature of the modification of the LMO, on its intended use, and on the scale and duration of the environmental introduction. As such, the case-by-case approach does not allow an existing risk assessment to be applied “as is” to different LMOs, uses or receiving environments.
If during the process, new information arises that could change the outcome of a step, the risk assessment may need to be re-examined accordingly. It can also change over time and differ according to other factors such as variations in the vulnerability of individuals or type of land use. The need and extent of toxicity tests will depend on characteristics of the LMO and the level of exposure of other organisms to the LMO.
If toxic effects are observed in early tier tests or if unacceptable uncertainty exists, e.g.
Insect-resistant Bt-crops similarly could lead to the emergence of Bt-resistant insects (FAO, 2004).
This information can be very valuable in determining the likely potential receiving environment and, consequently, the level of exposure to the LMO. It may also provide direct indications of how the LMO will behave in other managed environments.
If the genetic elements originate from a donor organism that is known to be a pest or pathogen it is also relevant to know if and how these elements contribute to the pest or pathogenic characteristics.
The third section explains some common actions that are undertaken when setting the context and scope of the risk assessment. If a human only comes into contact with the acid after it has been heavily diluted, the risk of harm will be minimal but the hazardous property of the chemical will remain unchanged (EEA, 1998).. Nevertheless, a risk assessment carried out on a case-by-case basis most often takes into account relevant knowledge and experience gained in previous risk assessments. Moreover, depending on the context, the step of the risk assessment and question being asked, a risk assessor may also choose to consider similar or related non-modified genotypes as useful comparators. This means that the characterization of the LMO (see below) will focus not only in the novel genotypic and phenotypic characteristics 6 resulting from the genetic modification, but rather on the characterization of an entire new genotype in the particular receiving environment. Likewise, the ecological characteristics of the recipient organism will help determine which organisms in the likely potential receiving environment are likely to come into contact, either directly or indirectly, with the LMO and will help determine the exposure pathways.
The fourth section discusses the specifics of the process of conducting the risk assessment, and follows the methodology and steps in Annex III of the Protocol along with a short description on how risk assessors may proceed in each of these steps.
Related management practices and experience with similar non-modified organisms may also be helpful.
However, if a cancer drug causes the same type of side-effects, it may not be considered harmful. For more details on the type of information that may be useful, see the section “Likely potential receiving environment” below. Under Step 1 of this section, an overview of the elements that form the basis of conducting a scientifically sound risk assessment, on a case-by-case basis, is provided. For example, when considering the risk assessment for an insect resistant LM crop, a risk assessor may wish to consider, amongst other things, the available experience with pest control practices applied to non-modified organisms of the same species (e.g.
Similarly, a plant producing large amounts of biomass in a pasture may be considered desirable whereas the same plant may be considered harmful (weedy) in a nature conservation area as it may end up displacing a native species. For each of these elements, this section also includes the “Points to consider” as outlined in Annex III of the Protocol, along with a short rationale as to how this information may be useful.
The fifth and final section of this module outlines how to communicate the findings and conclusions of the risk assessment process, and recommendations as to whether or not the risks are acceptable or manageable.



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