Article 15. Risk assessment

422. Article 15 establishes the basic requirements for risk assessment under the Protocol, and refers to Annex III for further guidance. Article 15 and Annex III are, therefore, closely connected. The objective of the risk assessment under the Protocol is, as stated in this Article and Annex III (1), to identify and evaluate the possible adverse effects of LMOs on the conservation and sustainable use of biodiversity, taking also into account risks to human health.

423. Annex III notes that risk assessment entails, as appropriate, the following steps:

424. The rest of this commentary will focus on the risk assessment provisions of Article 15. A separate commentary is provided on Annex III (see paragraphs 794–843).

Basis for the risk assessment

425. At a minimum, risk assessment for LMOs subject to the AIA procedure is to be based on information provided in accordance with Article 8 (including Annex I), and other available scientific evidence.

426. Relevant scientific evidence to be taken into account will include scientific data (including statistical data, if available), scientific theories, models, and other sources of scientific knowledge, that assist in the identification of possible adverse effects, and evaluation of the probability of adverse effects occurring, and of their consequences. Evidence that might not be regarded as scientific– for example, indigenous and traditional knowledge and information, as well as anecdotal information – might also be considered where relevant, provided consideration is carried out in a scientifically sound and transparent manner, such as through a scientific study of the issues raised.

427. There are, however, many variables that may change the response of an organism to an environment which have not yet been understood, and due to the complexity of the ecosystems may never be fully predictable. In some cases it may be difficult to even identify these effects, let alone predict the probability of them being realized. Furthermore, available information about ecological relationships and environmental factors in specific environments, and the response of a LMO to a specific environment, may be limited or non-existent, due to a lack of relevant research.

428. There may also be disagreement among scientists about the possible adverse effects associated with a LMO, including disagreement about the manner in which an inserted gene is likely to modify characteristics of the organism other than the intended changes, about the interpretation of data, and about the ecological and environmental effects of LMOs.

Scientifically sound manner

429. The risk assessment must be “carried out in a scientifically sound manner”. Box 29, taken from the UNEP International Technical Guidelines on Biosafety, gives examples of the types of scientific expertise and information that may need to be considered in undertaking risk assessments relating to LMOs. Further developments in these and other relevant scientific fields could also be taken into account.

Box 29. Examples of the types of scientific expertise and information for undertaking risk assessments relating to LMOs

Risk assessment requires a range of expertise which should be reflected in the competence and experience of those carrying out the assessment in a scientifically sound manner.

The different fields of expertise needed for scientifically sound risk assessment may include, as appropriate:

*Nucleic acid technology

*Plant biology/botany

*Molecular genetics

*Veterinary science

*Population genetics

*Agronomy

*Marine biology

*Forestry

*Ecology 

*Pathology

*Taxonomy 

*Epidemiology

*Microbiology

*Process technology

*Virology

* Biochemistry

*Zoology

*Toxicology

*Entomology

This list is provided as a guide to the major fields of expertise which may be required and is not intended to be comprehensive. Not all of these are likely to be relevant in each case and, as knowledge and technology advance, other fields of expertise will be important in risk assessment.

Source: UNEP International Technical Guidelines for Safety in Biotechnology, pp.21–22

430. There is no definition of the phrase “scientifically sound manner” in the Protocol. Indeed, there appears to be no internationally agreed definition of the phrase “scientifically sound”. Similar terms have been used in other international guidelines without definition.91 Identifying what constitutes a “scientifically sound manner” may give rise to disagreement between States. The phrase implies that risk assessment needs to proceed in a systematic way, and to be undertaken with inputs from people with appropriate qualifications and experience in fields relevant to the nature of the possible adverse effects.

431. Possible elements of a “scientifically sound manner” might include, for example:92 the review and evaluation of all available relevant scientific information; a case-by-case, structured and integrated approach; analysis using appropriate statistical techniques; peer review; a credible, transparent and inclusive evaluation mechanism; and the use of scientific advice from a wide variety of sources, including expertise in different disciplines and diversity of scientific schools of thought and opinion.

432. Specific guidance on the risk assessment process to be undertaken under Article 15 is provided in Annex III to the Protocol.

Possible adverse effects

433. The Protocol does not explain the term “possible adverse effects”. The possible adverse effects of LMOs that are to be identified and evaluated are those that might affect the conservation and sustainable use of biological diversity, taking also into account risks to human health. Based on the wording of Article 15, and on the methodology for risk assessment set out in Annex III, it would appear that all such possible adverse effects are to be identified. The evaluation of each possible adverse effect that has been identified then includes an assessment of the probability or likelihood of that adverse effect occurring, and of its consequences should it occur. Possible adverse effects to be considered may include both short-term and cumulative, long-term effects, as well as direct, indirect and delayed effects. For example, this approach is taken in EU legislation on release of LMOs into the environment (see Box 30).

Box 30. Categorization of direct, indirect, immediate and delayed effects

“direct effects” refer to primary effects on human health or the environment which are a result of the GMO itself and which do not occur through a causal chain of events;

“indirect effects” refer to effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management. Observations of indirect effects are likely to be delayed;

“immediate effects” refer to effects on human health or the environment which are observed during the period of the release of the GMO. Immediate effects may be direct or indirect;

“delayed effects” refer to effects on human health or the environment which may not be observed during the period of the release of the GMO but become apparent as a direct or indirect effect either at a later stage or after termination of the release.

Source: Annex II, Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms. OJ L 106/1 (17 April 2001).

Taking into account recognized risk assessment techniques

434. Risk assessments of LMOs under Article 15 are to take into account recognized risk assessment techniques. The Protocol does not specify what constitute recognized risk assessment techniques, but they may be assumed to include those techniques that are currently applied at national, regional or international level. In addition, risk assessment techniques that may be applied or developed in other areas may also be relevant for risk assessment of LMOs (e.g. techniques relating to alien invasive species).

435. Examples of such techniques would include the UNEP International Technical Guidelines on Biosafety and the OECD's work on risk assessment.93

436. Risk assessment strategies related to LMOs adopted by international and national systems are very similar. They are predominantly based on familiarity (i.e. knowledge and experience) with the unmodified donor and recipient and the likely impact due to the changed characteristics of the organism; with the intended application; and with the potential receiving environment.

437. This provision places an obligation on Parties of import to ensure that risk assessments are the basis for reaching decisions on proposed imports of LMOs that are subject to the Protocol's AIA procedure. The Party of import may perform the risk assessment, or alternatively, the Party of import may require the exporter to carry out the risk assessment.

438. In some countries, national authorities perform a risk assessment, on the basis of information provided by the applicant/notifier. In other countries, the authority responsible for decisions acts as an auditor of the risk assessment provided by the applicant. In the latter case, the applicant must provide a dossier containing the information used in the risk assessment and on proposed risk management measures, and the authorities review the data and the assessments. National authorities may ask for further information or clarification before deciding on the validity of the assessment in relation to the potential receiving environment(s).

439. Under the procedures to be adopted under Article 10(7), the Party of import may be able to request assistance, for example, through the roster of experts to review the information and risk assessment provided by the applicant/exporter.

440. The mechanisms used by Parties for carrying out or evaluating risk assessment may vary. Whatever mechanism is used, it is important that the requirements of risk assessment are clearly defined and systematically carried out. The individuals charged with risk assessment will need to be well qualified in the area under review, be individuals of the highest integrity, and meet requirements for public disclosure of actual and potential conflicts of interest.94

441. Parties may vary as to their approach to recovering the costs of the risk assessment procedures that are to be carried out under Article 15. In some cases, no charge may be made for the regulatory processes. However many countries may require fees from the applicant to cover either part or all of the costs of risk assessment (insofar as such costs can be determined).

442. This provision enables a Party of import, if it so wishes, to recover from the notifier the cost of risk assessment of the proposed transboundary movement.


91 For example, Statements of Principles concerning the Role of Science in the Codex Decision-Making Process and the Extent to which Other Factors are Taken into Account, Procedural Manual of the Codex Alimentarius Commission (12th edition, 2001), p. 165. Article 2(2) of the WTO SPS Agreement provides that any sanitary or phytosanitary measure must be “based on scientific principles”, and the Agreement contains further references to “scientific justification” (Article 3(3)) and “scientific evidence” (Article 2(2) and Article 5(2)).

92 See e.g. “Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology”, Report of the Third Meeting of the Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology, Appendix II, ALINORM 03/34; A Canadian Perspective on the Precautionary Approach/Principle: Discussion Document, September 2001, pp. 14–15, available at Health Canada online: http://www.hc-sc.gc.ca/english/protection/precaution.html

93 See, for example Report to the Working Group on Regulatory Oversight in Biotechnology (to the G8 Heads of State and Government), May 2002, OECD Reference No. C(2000)86/ADD1.

94 See, for example, the EU-U.S. Biotechnology Consultative Forum Final Report (December 2000) http://europa.eu.int/comm./external_relations/us/biotech/report.pdf

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