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Risk Assessment of LMOs - Training Manual

Module 4: Preparing a Risk Assessment Report


Contents of this Module

       
1. Introduction »
2. Background, context and scope of the risk assessment »
3. Characterization and estimation of risks »
4. Description of risk management and monitoring strategies »
5. Consideration of remaining uncertainty »
6. Recommendations as to whether or not the risks are acceptable or manageable »
7. References »

Using this module

This module explains how risk assessors can communicate the outcomes of a risk assessment in a report structured to provide information on (i) background, context and scope of the risk assessment; (ii) characterization and estimation of risks; (iii) description of risk management and monitoring strategies; (iv) consideration of remaining uncertainty; and (v) recommendations as to whether or not the risks are acceptable or manageable.

An overview of what type of information could be included under each of these topics is also part of this module.

1. Introduction

The outcomes of a risk assessment are often presented in the form of a written report prepared by the risk assessor(s).

The report is primarily intended to assist the decision makers in making informed decisions regarding the safe use of an LMO.

Presenting the results of a risk assessment could be categorized as a form of risk communication. As in any form of communication, risk assessors should be mindful of the intended recipients, which in addition to decision makers may also include regulators, risk managers, other risk assessors and the general public amongst others.

     
 
Example 1 – Risk communication

Risk communication is the interactive exchange of information and opinions among assessors, risk managers, consumers, industry, the academic community and other interested parties throughout the risk analysis process. The information exchange concerns risk-related factors and risk perceptions, including the explanation of risk assessment findings and the basis of risk management decisions. It is vitally important that risk communication with the public comes from credible and trusted sources.

Source: FAO (2001).
 

It is important that the report is presented in a well-structured form, which not only facilitates the deliberations of decision makers, but also allows for an easier exchange of information and experience. The context and scope of the risk assessment should be clearly explained as other institutions (e.g. in the same or in different countries) may have an interest in understanding how the risk of a particular LMO was assessed.

With regard to sharing of information, a Party to the Protocol is required to submit to the Biosafety-Clearing House (BCH) all “summaries of its risk assessments or environmental reviews of living modified organisms generated by its regulatory process, and carried out in accordance with Article 15, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology” (Article 20). This will include all risk assessments generated to support decisions regarding LMOs for intentional introduction into the environment (Articles 8, 10 and 13) or for direct use as food or feed, or for processing (Article 11) whether they are triggered by a transboundary movement or by an internal request.

The required contents and format of a risk assessment report are generally defined by the Competent National Authority(ies) that have the responsibility to make decisions on the LMO(s) in the context of the national biosafety framework.

A risk assessment report typically comprises of an analytic synthesis of all the relevant steps and results of the risk assessment process, including an overview of the context and scope of the risk assessment, methodology used and a detailed summary of the results of the overall risk estimation, including the identification of individual risks, as well as the likelihood and consequences of the potential adverse effects.

The report may also contain an evaluation of the availability and quality of the scientific and technical information that was deemed necessary to perform the assessment and characterize the risks, and whether or not there were gaps in the information.

An analysis of all identifiable uncertainties and how they may impact the overall conclusions of the assessment is also a critical element of the report. This includes uncertainties identified at each step of the risk assessment process as well as those remaining at the end of the risk assessment.

Finally, the risk assessment report often contains a set of recommendations regarding the acceptability and manageability of the risks posed by the LMO and the identification of appropriate risk management and monitoring strategies. The information above can be organized under five broad topics depending on the requirements of the National Authority that is responsible for the risk assessment:
  1. Background, context and scope of the risk assessment;
  2. Characterization and estimation of risks;
  3. Description of risk management and monitoring strategies identified during the risk assessment;
  4. Consideration of remaining uncertainty; and
  5. Recommendations as to whether or not the risks are acceptable or manageable.

An overview of the information which may be included under each of these topics may be found in the following sections of this module.

2. Background, context and scoping of the risk assessment

This part of the report focuses on describing issues that were considered while setting the context and scope of the risk assessment. Basically, this section of the report sets the scene for the reader to follow a clear progression through the subsequent sections of the report.

A risk assessment report usually specifies the mandate that was given to the risk assessor(s) and includes a description of the procedure that was followed in conducting the risk assessment, an indication of which institution has carried out the risk assessment, and which, if any, other institutions were consulted or were part of the process. Any other information that helps in understanding the context in which the risk assessment was carried out is also typically included in this part of the report.

Previous approvals or prohibitions of the same LMO, if any, including the regulatory status of the LMO in the country of export or import as well as in any other country may also be included in this section, if appropriate.

The report should describe how the requirements of the national regulatory framework were taken into account including which protection goals were identified as relevant in the context of the risk assessment and how assessment endpoints were selected.

In summary, the following information may be included in this section of the report:
  1. Contact details of the LMO developer;
  2. Type of approval sought (e.g. introduction into the environment);
  3. Contact details of the institution responsible for the risk assessment;
  4. Relevant regulation;
  5. Relevant protection goals and assessment endpoints;
  6. Previous approvals or prohibitions of the same LMO;
  7. Overview of the terms of reference for the risk assessment; and
  8. Consulted experts or panel of experts, if applicable, and how the involved experts were chosen and how possible conflict of interests were identified and was managed.
In some cases, the bulk of information presented in this section of the report may be extracted from the request triggering the risk assessment, the national regulatory framework, including environmental and biosafety policies or guidelines, and national biosafety-related databases.

3. Characterization and estimation of risks

This section of the report focuses on the outcomes of the risk assessment steps in accordance with Annex III of the Protocol and as described in Module 3.

Depending on the specific mandate and scope of the risk assessment, the following information may be included in this section of the report:
  1. Description of the LMO (e.g. recipient or parental organism(s), transformation method, inserted or modified sequences, novel traits, purpose of the genetic modification), its intended use and the likely potential receiving environment(s), including considerations on how the baselines were established and appropriate comparator(s) chosen;
  2. Considerations of the availability and quality of information used during the risk assessment;
  3. Methodology used in the risk assessment, explaining, if necessary, the use of terms;
  4. Description of the potential adverse effects and risk scenarios arising from the novel characteristics of the LMO;
  5. Analyses of the likelihood and consequences of each identified potential adverse effect; and
  6. Estimation of the overall risk posed by the LMO.
The information relevant to each of the items above may vary in nature and level of detail on case-by-case basis, depending on the LMO concerned, its intended use and the likely potential receiving environment.

While information related to the description of the LMO and its intended use may be obtained in part from the LMO application, the bulk of information to be presented in this section of the report is obtained through the risk assessment process for the specific case at hand.

4. Description of risk management and monitoring strategies

If risk management and monitoring strategies were identified during the risk assessment process (see Module 3), the risk assessment report should contain a section detailing any strategies to minimize the risks identified.

The risk assessment report may include, for instance:
  1. How each identified strategy is expected to contribute to minimizing the likelihood or consequence of potential adverse effects (e.g. by reducing the exposure to the LMO or the consequences of the potential harm);
  2. Details of the methodology for each identified risk management or monitoring strategy including, for instance, the frequency, locations and methods of sampling, as well as methods of analysis, including laboratory testing when appropriate;
  3. Any uncertainty regarding the effectiveness of any such management or monitoring strategy;
  4. An indication as to whether and how different management strategies can be combined to further minimize uncertainty or identified risks; and
  5. Considerations on unintentional introduction into the environment and emergency measures as appropriate (see Article 17).

5. Consideration of remaining uncertainty

As seen in the previous module (Module 3, section 5), uncertainty is an inherent component of any risk assessment, and should be considered in a systematic manner at each step of the risk assessment process. Nevertheless, at the end of the risk assessment, uncertainties may still remain with regard to one or more specific steps in the process or about the likelihood or consequences of the potential adverse effects.

Annex III of the Protocol addresses this matter by requiring that “Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment”.

Considerations of remaining uncertainties should be included in the risk assessment report. These considerations may include:
  1. Identification of major information gaps and, where appropriate, indication of whether gathering additional data (either before the release or after it by monitoring) would significantly increase the overall confidence in the results of the risk assessment;
  2. An analysis of uncertainty, including its types (e.g. gaps in the available information, limitations of the assessment methodology);
  3. Discussion on the level of scientific support to issues where there is uncertainty, including an analysis of different scientific views;
  4. Discussion of any assumption used in assessing the risks, including its strengths and weaknesses;
  5. Discussion of the potential for uncertainties to impact on the overall conclusions of the risk assessment; and
  6. Identification of any threats of serious or irreversible damage to the environment (basis for the adoption of the precautionary approach).

     
 
Example 2 – Uncertainty and a precautionary approach

“The implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty. Decision-makers need to be aware of the degree of uncertainty attached to the results of the evaluation of the available scientific information. Judging what is an “acceptable” level of risk for society is an eminently political responsibility. [...] Where possible, a report should be made which indicates the assessment of the existing knowledge and the available information, providing the views of the scientists on the reliability of the assessment as well as on the remaining uncertainties. If necessary, it should also contain the identification of topics for further scientific research.”

Source: Commission for the European Communities (2000).
 

6. Recommendations as to whether or not the risks are acceptable or manageable

Recommendations are one of the most important sections of a risk assessment report as they take into account the outcomes of the risk assessment to provide direct science-based advice to the intended recipients of the report. A recommendation as to whether or not the risks are acceptable or manageable should be kept within the scope of the risk assessment and based on its findings.

It is important to note that risk assessor(s) are requested to recommend whether the risks are “acceptable” or not. However, the definition of "acceptability" may not be part of a risk assessment but could be pre-established, for example, in thresholds included in government policies or in the mandate given to the risk assessor. Likewise, the final decision on whether to approve (with or without conditions) or prohibit the specific use of the LMO is taken during the decision-making process, which may take into account, depending of the national regulatory framework and among other things, government policies, public opinion, costs of the risk management measures and socio-economic considerations.

In addition to the issues mentioned above, the recommendations section of the report may also include any relevant information to be considered by the decision makers prior to making a decision. Some issues that may be relevant include:
  1. A recommendation as to whether or not one or more risk management or monitoring strategies should be implemented and, if so, the specific conditions for each such strategy (see section 4 above);
  2. Considerations of remaining uncertainties (see section 5 above); and
  3. A recommendation as to if and when the risk assessment should be re-visited.

7. References

  1. Commission for the European Communities (2000) Communication from the Commission on the precautionary principle. Commission of the European Communities, Brussels, 29 pp. Available at http://ec.europa.eu/dgs/health_consumer/library/pub/pub07_en.pdf (access May 2010).

  2. FAO (2001). Genetically modified organisms, consumers, food safety and the environment. Food and Agriculture Organization (FAO), Rome, 35 pp. Available at http://bch.cbd.int/database/record-v4.shtml?documentid=41952 (access May 2010).