Article 16. Risk Management

443. The purpose of risk management as provided in Article 16 is to regulate, manage and control risks identified in risk assessments carried out under the Protocol.

444. This Article deals with the management of risks of those organisms that fall within the scope of the Protocol (i.e. all LMOs covered by Article 4) and refers to the provisions of Article 8(g) of the CBD, which requires Parties to the CBD to:

establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health.

445. Article 16(1) places an obligation on Parties to set up appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment provisions of the Protocol. The obligation implies the establishment and implementation of a regulatory system with the capacity to manage and control such risks.

446. The Protocol does not give any specific guidance on how suitable risk management strategies may be identified. However in order to manage risk, risk management strategies will need to be effective when applied in practice by those who will have the responsibility for implementing them, for example, farmers or distributors of LMOs. In the identification of risk management mechanisms, measures and strategies it is therefore important to consider the feasibility of the measures proposed in the circumstances in which they will be carried out in practice. Identification of risk management strategies could also, taking into account Article 23(2), consider the many different views of those affected by the introduction into the environment of LMOs covered by the Protocol, so as to ensure that differing technical assessments, public values, knowledge, and perceptions are considered.

447. For the release of LMOs that are plants, risk management measures that are commonly applied include the following:

448. Risk management measures, such as those above, have been developed and applied mainly in countries where farms are managed as large single units. They may well need to be adapted if they are to work effectively under different conditions, such as in situations where there are many small farms, each managed separately, as is common in many developing countries.

449. While the Protocol does not specifically require risk management measures to include a component for monitoring the application and effectiveness of the measures, and strategies to manage adverse effects resulting from poor implementation, or ineffectiveness, of these measures, it may be considered that these elements are part of “management and control”.

450. “Measures based on risk assessment” refers to the measures to regulate, manage and control those risks that are identified through the risk assessment provisions of the Protocol, as described in Article 15(1) and 16(1).

451. The obligation established under this Article “to impose measures to the extent necessary to prevent adverse effects” differs from, and in the use of the word ‘prevent’ would appear to be stronger than, the wording and approach used in the wording of Articles 10(6) and 11(8) on application of the precautionary approach in the decision procedure, which refers to avoiding or minimizing adverse effects.

452. The management measures to be imposed here are those necessary to prevent adverse effects of LMOs on “the conservation and sustainable use of biological diversity, taking also into account risks to human health, within the territory of the Party of import”. Consistent with Article 16(1), this provision places an obligation on Parties to impose risk management to prevent adverse effects.

453. An unintentional transboundary movement might occur by spread of LMOs through growth and dispersal, for example, where a LMO is grown close to an international border. Unintentional transboundary movement may also occur through local, informal trade, errors in handling of shipments or through illegal activities. Article 16(3) requires that the risk assessment needed before the first release of a LMO takes into account the possibility of unintentional transboundary movements of LMOs across international borders (for further discussion of unintentional transboundary movement, see commentary on Article 17).

454. Article 16(4) requires each Party to endeavour to ensure that, all LMOs undergo an appropriate period of observation before being put to their intended use. The use of the word “endeavour” indicates an obligation to put in place measures to achieve the goal set out in Article 16(4).

455. The placing of this requirement in the Article 16 on risk management suggests that its provisions are in addition to provisions for risk assessment in Article 15 and Annex III.

456. The wording does not specify where this observation is to take place: it could take place in the territory of the Party concerned, or in other countries. However, if an initial risk assessment suggests that there are significant differences between the place where the period of observation has occurred, and the receiving environment, then a further period of observation, commensurate with the lifecycle or generation time of the LMO concerned, may be necessary. This would need to take place in the potential receiving environment, or in a comparable environment in another Party, in order to be able to complete the risk assessment in relation to the potential receiving environment.

457. Article 16(4) specifies that this observation is to be undertaken before the LMO is put to its intended use.

458. The “life-cycle” or generation time will depend on the LMO concerned. In the case of trees or long-lived animals, for example, a life-cycle could be measured in years or even centuries. However, the generation time – the time taken from germination or birth for the organism to produce progeny/offspring – will generally be shorter than the period of their life-cycle. The reason for the reference to a period of observation commensurate with the life-cycle is that this would permit observation of how a LMO behaves under different stages of its life-cycle, which may be associated with internal changes within the organism affecting physiology, biochemistry, gene expression, etc. associated with maturation and ageing. It also recognizes that ecological effects may take a significant period of time before they become apparent. The phrase “commensurate with its life-cycle or generation time” could therefore imply a period of observation at least as long as a generation time, or a period in which all major stages of the life-cycle are manifest.

459. It is important to note that for organisms with short life-cycles (for example, insects, bacteria or short-lived plants) the requirements for risk assessment may well necessitate observation and testing for periods that may be many times longer than their short lifecycles. In addition, many organisms, including those with short life-cycles, may produce very long-lived spores or other resting stages. For example, ancient viable microorganisms are reported to have been extracted from archaeological sites; some seeds and some invertebrates are also amongst organisms known to have long-lived resting stages. Such resting stages will need to be taken into account in the context of the period of observation.

460. Article 16(5) places an obligation on Parties to cooperate in two specific instances. The first relates to the sharing of information and methods of management to identify organisms or traits which may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. The second relates to cooperation regarding appropriate treatment of the organisms and traits identified, potentially including the development and implementation of concerted strategies to counter their adverse effects.

461. Concerns about certain characteristics introduced into LMOs, such as antibiotic resistance markers, were raised during the Protocol negotiations. A specific provision to facilitate concerted action by the Parties to the Protocol to phase out the use of antibiotic resistance markers was proposed by some countries. However, in view of the rapid developments within genetic engineering, it was felt that the general provision provided by Article 16(5) would be more appropriate. Parties may decide to take concerted action in relation to antibiotic resistance markers, but they are not specifically obliged to do so. In addition, Article 16(5) enables Parties to take concerted action in relation to any LMOs, or specific traits of LMOs, that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

462. Article 16(5) is also relevant in relation to neighbouring countries that are likely to have common interests in risk assessment and management, or countries sharing similar geographical or climatological characteristics that may wish to share information about organisms produced or grown in their territories. The information gained about the characteristics of growth and fitness within particular environments may provide guidance as to the behaviour in other similar environments, and may assist in assessing and/or managing any risks posed by LMOs or the inserted characteristics.

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