Article 12. Review of decisions

376. Article 12 addresses the changing state of knowledge about LMOs and their potential impacts on biological diversity and human health. It provides for the review of decisions on imports of LMOs in the light of new information or circumstances. It addresses:

377. Under Article 12 a review of an import decision relating to a particular LMO can be initiated by either:

378. A request for a review of a decision may be made at any time provided the requirements of Article 12 are met.

379. Paragraphs 1 and 2 of Article 12 set out the circumstances which may give rise to a review of a decision.

380. For the Party of import to initiate a review, there must be:

381. This suggests that scientific information must be available which was not available at the time the original decision was taken. While not explicitly stated in Article 12, it appears that the Party of import may review any type of decision, i.e. an approval of an import; a prohibition of import; or conditions attached to the import of a LMO.

382. For a Party of export or notifier to request a review, there must be either:

383. Again, a Party of export or notifier may presumably request any type of decision to be reviewed. It can be envisaged that various factors may give rise to a change in circumstances for the purposes of Article 12 such as to prompt a request to review a decision. Presumably, the types of factors to be considered in determining whether or not such a change in circumstances has occurred are the factors reflected in Annexes I and III – i.e. information provided in the notification, and the guidance on risk assessment. For example, one relevant change in circumstances which might occur could be a change in the proposed receiving environment of the LMO in question. Others might be the availability of improved detection and identification methods for the LMO, or a change in the intended use of the LMO.

384. If the Party of export or notifier does request review of a decision, the Party of import has 90 days in which to respond to that request with reasons. In order to fulfil the requirement to give reasons the Party of import is likely to have to review the original decision and the risk assessment on which it was based in the light of the new information or circumstances. However, Article 12 does not provide that the decision procedure in Article 10 should apply anew to requests for review. In contrast to Article 10, Article 12 does not explicitly give the Party of import an opportunity to request additional information from the notifier during this period or unilaterally to extend the time period within which the result of its review will be communicated. Nonetheless, it may be necessary for a Party of import to request additional information from the Party of export or notifier in order to ascertain whether the change in circumstances or additional relevant scientific and technical information is such as to warrant a change to the original decision. The 90 days time limit within which to respond to requests for review may prove problematic for certain countries with limited human, technical and/or financial resources. In particular, and in contrast to Article 15(3), Article 12 does not explicitly provide that the Party of import may require the Party of export or the notifier to bear the costs of the review. This may be addressed in the domestic law of the Party of import.

385. Article 12 does not provide an “appeal” as such against the original import decision of the Party of import – i.e. the Party of export or the notifier cannot use Article 12 simply to challenge the decision of the Party of import taken in accordance with Article 10, unless they can point to changed circumstances or additional relevant scientific information, However, if they can identify such circumstances or information, the Party of export or notifier may ask for a review of the decision at any time. During the negotiations, there was discussion of including a provision in Article 12 whereby a Party of export or notifier could request a review of a decision if there was reasonable evidence that the original decision was not based on scientific principles and evidence. This provision was not agreed.84 Of course, it is open to a Party of import to make provision for an additional appeal procedure in its national regulations or other procedures may already exist in its national law for the review of administrative decisions.

386. The possibility to review decisions provided by Article 12 of the Protocol is an important element in assessing the compatibility of the Protocol with relevant WTO agreements (see Appendix).

387. As noted previously, the Protocol's AIA procedure applies to the first intentional transboundary movement of a LMO for intentional introduction into the environment of the Party of import. Article 12(4) addresses the situation in which, having taken a decision allowing the first import of a particular LMO for intentional introduction into the environment, the Party of import may nonetheless wish to subject subsequent imports of the same LMO to risk assessment. The Party of import may wish to do this where, for example, the intended use of the LMO changes, the receiving environment changes, or the volume of imports changes so as to increase the risk of adverse impacts on the conservation and sustainable use of biodiversity, taking into account risks to human health.85 It is conceivable that a decision of a Party of import allowing the first import of a LMO could specify, as a condition of import, that if any of the above-mentioned circumstances arise (or others) then a new risk assessment would be required. However, Article 12(4) suggests that it is not necessary for the Party of import to do this in order to be able at a later stage to exercise its discretion to require a further risk assessment to be carried out.

388. During the negotiations, there was discussion on whether Article 12 should include a list of the circumstances under which the Party of import might exercise its discretion to require risk assessments for subsequent imports. However, these proposals were not included in the final text.


84 Earth Negotiations Bulletin Summary of BSWG 6, pp5–6, available at: http://www.iisd.ca/linkages/download/asc/enb09110e.txt

85 Earth Negotiations Bulletin Summaries of BSWG 5 and 6, available at: http://www.iisd.ca/linkages/vol09/

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