Article 10. Decision procedure

309. Article 10 sets out the procedure to be followed by the Party of import in reaching its decision on whether to allow the first transboundary movement of a LMO into its territory for intentional introduction into the environment. The Article addresses:

310. Article 10 needs to be read in conjunction with Article 15. Article 10 provides that the decision of the Party of import must be based on a risk assessment. Risk assessment is addressed in more detail in Article 15 and Annex III to the Protocol.

311. It is the responsibility of the Party of import to base its decision on a risk assessment (see commentary on Article15(2)). However,

312. In reaching a decision on whether to allow the import of a specific LMO, the Party of import can also take into account:

313. Article 23 on public awareness and participation also imposes obligations on Parties which are relevant during the decisionmaking process in Article 10 (see commentary on Article 23 below).

314. Essentially, under Article 10 the Party of import has to communicate to the notifier (and to the Biosafety Clearing-House) its decision on whether to allow the import within 270 days of receiving the notification of the proposed transboundary movement (see commentary on Articles 8 and 9). If the Party of import does not communicate its decision within this period, the import cannot go ahead – i.e. the Party of import's consent cannot be implied.

315. The decision of the Party of import may:

316. The Party of import has to give the notifier reasons for its decisions, unless it unconditionally approves the import.

317. The decision of the Party of import on the proposed transboundary movement must be based on a risk assessment carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques. Article 15 sets out the risk assessment requirements in more detail. Annex III contains guidance on the objective of risk assessment, general principles of risk assessment, the methodology to be applied, and points to consider in risk assessment.

318. The Party of import may also take into account certain socio-economic considerations pursuant to Article 26 of the Protocol, in reaching a decision on the proposed import.

319. Under Article 9, when a Party of import receives notification of the proposed transboundary movement of a LMO, it has 90 days within which to acknowledge receipt of the notification. Under Article 10(2), the Party of import is also required at that stage to tell the notifier in writing whether the import can only take place once written consent has been given. In practice, a Party of import may select to impose a general requirement in its national legislation for written consent prior to the first import of a specific LMO.

320. Paragraph 3 defines the time limit for an import decision and the possible content of that decision.

Time limit

321. The 270-day period specified in the Protocol is amaximum (subject to Article 10(3)(c) and (d)). There is nothing to prevent Parties from specifying a shorter decision period in their national biosafety legislation if they so wish and if they have the capacity to reach a decision within a shorter time. If not, then the 270-day period will apply.

322. Moreover, in certain circumstances, the 270- day period may be extended. These circumstances are:

Content of decision

323. As specified in Article 10(3), the Party of import may approve the transboundary movement, with or without conditions, prohibit the import, request additional information, or specify an additional time period within which the decision will be taken. Conditions attached to a consent may address, for example, risk management measures, including monitoring, that may be required in relation to Article 16.

324. The focus of the AIA procedure is on the transboundary movement of LMOs. The decision to be taken by a Party of import under Article 10 is a decision on whether or not to allow the import of a particular LMO and under what conditions (if any). As noted in paragraph 290 above, this decision of the Party of import may not necessarily cover the final use of a LMO in the Party of import once it has been imported. Any proposed use of the LMO may thus potentially be subject to a separate approval procedure in the Party of import. This is amatter for clarification in the relevant national legislation.

Notification of decision

325. The decision on whether or not to allow the import of LMOs must be communicated in writing to the notifier, i.e. the exporter or the Party of export (see commentary on Article 8) and to the Biosafety Clearing-House (see commentary on Article 20).

326. Notification to the Biosafety Clearing-House allows other Parties, as well as exporters, importers and others, to find out which LMOs have been approved for import for intentional introduction into the environment by a Party to the Protocol, and under what conditions (if any).

Subsequent imports of the same LMO

327. If the Party allows the import of the LMO in question, it must, in its decision, specify how that decision will apply to subsequent imports of the same LMO. For example, the Party of import may simply permit future imports of that LMO, under the same conditions, without further administrative requirements. Alternatively, it may, for example:

328. As mentioned previously in relation to Article 7(1), it may not always be simple to determine whether a LMO being imported into a Party of import is the “same” as one that has already been approved for import (see paragraph 271).

329. Under Article 12(4), a Party of import may in any event require risk assessment for future imports of the same LMO. This may be relevant where the circumstances under which the LMO is imported change – for example, there is a change in the intended use, or in the receiving environment, or in the quantities of the LMO being imported into the Party of import.

330. A Party of import may also wish to consider at this stage the need to impose an ongoing obligation on the notifier, and/or on other persons/entities such as the importer, to inform the Party of import of any new information which may become available about the LMO in question, for example as to its potential effects upon the environment or human health (see commentary on Article 12(4)). New information may necessitate a review of any risk assessment and/or of an import decision.

331. A Party of import must give reasons to the notifier for its decision. Under the Protocol, reasons are not required where an unconditional consent is given. The reasons given for a decision are likely to be important in the event that the notifier wishes to challenge the decision (or conditions attached to an import) under any available domestic procedures in the Party of import. They will also be important if the notifier subsequently requests the review of the decision (see commentary on Article 12).

332. As noted in relation to Article 9(4), there were extensive discussions during the Protocol negotiations as to whether, and if so in what circumstances, consent to an import of a LMO could be implied, or whether in all cases explicit consent of the Party of import should be required before a transboundary movement could proceed.

333. Article 10(5) addresses the situation where a notifier submits a notification to the Party of import of a proposed transboundary movement of a LMO subject to the AIA procedure, but does not receive any response from the Party of import within 270 days. Under the AIA procedure established in the Protocol, there can be no implied consent to a transboundary movement of a LMO into a Party of import. If the Party of import does not communicate its decision in accordance with Article 10, i.e. within 270 days, the exporter is not authorized under the Protocol to proceed with the export.

334. This provision is largely intended to protect countries which may, for whatever reason, have been unable to communicate a response within the 270-day period specified. However, it is not intended to make way for an open-ended delay. Where a Party of import has difficulties in reaching a decision, it may be able to avail itself of the procedures and mechanisms established under Article 10(7) – for example utilizing assistance of the roster of experts.

335. As noted in relation to Article 9, the Protocol is not entirely clear as to what the consequences of non-response in these circumstances are. It is not explicitly stated in the Protocol that transboundary movement of LMOs for intentional introduction into the environment cannot take place without written consent. Article 10(7) provides only that a failure by a Party of import to communicate its decision within 270 days “shall not imply its consent to an intentional transboundary movement”. However, in this regard, it is interesting to compare the wording of Article 10(5) with that of Article 11(7), which deals with the failure to communicate a decision on the proposed import of LMO-FFPs. Article 11(7) provides that a failure by a Party to communicate its decision “shall not imply its consent or refusal to the import” (emphasis added). It might be argued that this difference in wording can be understood to imply that a failure to communicate a decision under Article 10 can be taken as implied refusal of the import.

336. In any case, the Protocol makes it possible for Parties to make explicit written consent a precondition for imports through their domestic regulations (see commentary on Article 10(2)(a)), and this seems to accord with the intent of an AIA procedure. Once again, clarity can be achieved through a Party's national implementing legislation. For the sake of certainty, Parties could consider incorporating into their national law a clear requirement for explicit consent prior to the first import of a LMO.

337. A related question is whether there is any obligation upon Parties of export to specify in their national legislation that a transboundary movement of a LMO covered by the AIA procedure must not proceed without the express written consent of the Party of import. This is complicated by the fact that the definition of “transboundary movement” in the Protocol (see commentary on Article 3 (k)) does not specify when a transboundary movement has actually occurred – i.e. is there a transboundary movement as soon as the LMO leaves the Party of export, or only when that LMO arrives in the Party of import? And, in practical terms, can the transboundary movement begin before the consent of the Party of import has been received, as long as it is given before the LMO arrives in the Party of import? (Although in such circumstances the notifier would bear the risk that approval may not be given). The Protocol does not explicitly require Parties of export to hold back exports of LMOs until the consent of the Party of import has been received. Nonetheless, such a measure on the part of exporting Parties may promote full implementation of the Protocol, and would also promote certainty.

338. In terms of its obligations under the Protocol, the Party of import would prima facie be in breach of its obligation under Article 10 if it failed to respond within 270 days in one of the ways identified in Article 10(3)(a)–(d), even if such a failure would not result in consent to the import being implied.

339. Article 10(6) is generally taken to reflect the precautionary approach (see Introduction). The inclusion of operative provisions in the Protocol on the right of Parties to take precautionary measures in relation to imports of LMOs was among the most contentious issues in the Protocol negotiations.

340. Article 10(6) addresses the situation where, having carried out a risk assessment based on information provided in accordance with Annex I, and on the basis of Article 15 and Annex III, the Party of import concludes that there remains a lack of certainty about the extent of potential adverse effects of the LMO on the conservation and sustainable use of biological diversity, taking also into account risks to human health. It is also relevant to a situation where there is insufficient information to carry out a risk assessment. The basic question addressed during the negotiation was: in such circumstances, should a Party be able to prohibit the proposed import, or attach conditions to it, on the basis of the precautionary approach?

341. As adopted, Article 10(6) represents one of the most explicit examples of the implementation of the precautionary approach in any multilateral environmental agreement. Where the conditions in Article 10(6) are met, a Party of import has the right under the Protocol to base its import decision on the precautionary approach.

342. This provision requires the first meeting of the COP/MOP (see commentary on Article 29) to decide on procedures to facilitate decisionmaking on imports. The potential scope of this provision remains somewhat unclear. On the one hand, it could relate primarily to building capacity in countries which have yet to put in place or implement national biosafety frameworks, and which need assistance in developing the legal, institutional or technical capacity to do so. On the other, it might conceivably extend to the development of supplementary procedural standards under the Protocol, such as the development of standard notification and import decision formats, decision guidance documents, or other technical guidelines.

343. In preparation for the first meeting of the COP/MOP, Article 10(7) was addressed at the first and second meetings of the ICCP. The ICCP has made a recommendation to the COP/MOP setting guidelines for procedures and mechanisms to facilitate decision- making, as well as procedures relating to access to the roster of experts, which was established in accordance with decision EM–I/3 of the CBD COP.82 The ICCP has recommended that procedures and mechanisms to facilitate decision-making should be demand-driven by Parties of import. The main mechanisms envisaged to provide support for decisionmaking are the roster of experts and the Biosafety Clearing-House.

82 ICCP Recommendation 2/7, UNEP/CBD/ICCP/2/15, Annex I.

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