Under Article 11(1), a Party making a final decision regarding the release (domestic use and placing on the market) of an LMO at the domestic level where LMOs may be exported for direct use as food or feed, or for processing (LMO-FFP), must make it available through the BCH within 15 days of reaching the decision.

 

Parties to the Protocol that usually import agricultural commodities for food, feed or for processing may respond to such information regarding the commercialization of LMO-FFP by taking a decision under their domestic regulatory frameworks which have to be consistent with the objective of the Protocol. Each Party is required to make available through the BCH, copies of any laws, regulations and guidelines, if any, applicable to the import of LMOs-FFP (Article 11.5). This requirement is intended to promote transparency and predictability by allowing a person who intends to export a LMO-FFP to a Party to the Protocol to find out through the BCH what national regulations of the importing Party will apply to the proposed export.

 

This 15-day reporting window applies when, for example, a Party decides to permit the commercial marketing of a genetically modified maize plant within its territory that could subsequently be exported for animal feed or for processing for food or other use. By way of another example, it would also apply to a decision permitting the growing of domestically developed genetically modified cassava which may be exported for direct use as food, or for processing. (Note that if this cassava were then exported to another Party to be planted, it would fall under their AIA procedure since it would then be intended for introduction into the environment of the importing Party.)

 

Article 11 also applies to LMOs for direct use for processing. Examples of such LMOs may include those used in industrial processes for the production of plastics or oils.

 

The requirement to inform other Parties through the BCH  is not mandatory where the Party concerned has approved the LMO in question only for local field trials and it will not subsequently be exported or otherwise be moved into another Party’s territory.

 

In contrast to the AIA procedure, Article 11 of the Protocol does not require a Party exporting an LMO-FFP, or an exporter of a LMO-FFP, to provide any notification or information directly to the importing Party. Any such obligation will only be triggered by the domestic regulations of the importing Party. In practice, however, the domestic requirements of the importing Party often result in first imports of an LMO-FFP being subject to procedures similar to AIA. For example, the importing country‘s biosafety framework may require prior notification of a first import of an LMO-FFP, as well as a risk assessment, and explicit approval.)

 

In the absence of a domestic regulatory framework, a developing country Party or a Party with an economy in transition may declare that it will take a decision with regard to a first import of an LMO-FFP following the procedures specified under paragraph 6 of Article 11. This is to ensure that any such Parties which do not yet have in place a domestic regulatory framework to address imports of LMO-FFPs may nonetheless subject LMO-FFP imports to prior notification and approval procedures in a manner consistent with the Protocol's objective. Any such Party which does not have a domestic regulatory framework for LMO-FFP imports in place, but which wishes to subject such imports to prior assessment and approval, should indicate this by making a declaration to this effect through the BCH.

 

Article 14 addresses the situation where Parties to the Protocol have concluded, or intend to conclude, a separate agreement or arrangement on intentional transboundary movement of LMOs. For example, it is possible that two neighbouring countries, which trade actively in LMOs, may decide to conclude an agreement that is more specific than the Protocol and is tailored to the particular situation and needs of those countries.

An example of such an agreement could be the case of the European Union and its member States. As Parties to the Protocol, the European Community and its members may wish to apply, in precedence over the provisions of the Protocol, relevant EU legislation both within the internal market of the EU and to imports of LMOs from third-party States into the EU.