Under the Protocol, the Advance Informed Agreement (AIA) procedure applies to the first intentional transboundary movement of an LMO for intentional introduction into the environment of the Party of import.
The advance informed agreement or AIA procedure is designed to ensure that before an LMO is imported into a country for the first time for intentional introduction into the environment, the Party of import:
a) Is notified about the proposed import
b) Receives full information about the LMO and its intended use
c) Has an opportunity to assess the risks associated with that LMO and to decide whether or not to allow the import
The AIA procedure includes (1) communication and (2) decision-making processes between the Parties:
(1) Communication process:
a) The Party of export or the exporter must notify the Party of import of the proposed transboundary movement in advance of the first shipment, providing detailed, written information about the LMO and its intended use.
b) The Party of import is to acknowledge receipt of this information within 90 days.
c) Then, within 270 days of the date of receipt of notification, the Party of import must make a decision and communicate it to the notifier and the BCH either: (i) approving the import, (ii) prohibiting the import, (iii) requesting additional relevant information, or (iv) extending the 270 days by a defined period of time. Unless unconditional consent is given, the Party of import must give reasons for its decision.
(2) Desicion-making process:
a) The decision of the Party of import must be based on a risk assessment.
b) Parties may also take into account certain socio-economic considerations in making a decision whether or not to allow the import of an LMO.
c) The Protocol allows Parties to take decisions based on the precautionary approach where there is a lack of scientific certainty due to insufficient scientific information and knowledge regarding the extent of possible adverse effects of an LMO.
Principle 15 of the Rio Declaration on Environment and Development states:
"In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."
Elements of the precautionary approach find reflection in a number of the provisions of the Cartagena Protocol, such as:
The preamble[1], reaffirming "the precautionary approach contained in Principle 15 of the Rio Declaration on environment and Development";
Article 1,[2] indicating that the objective of the Protocol is "in accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on environment and Development";
Article 10.6[3] and 11.8,[4] stating "Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of an LMO on biodiversity, taking into account risks to human health, shall not prevent a Party of import from taking a decision, as appropriate, with regard to the import of the LMO in question, in order to avoid or minimize such potential adverse effects."
Annex III[5] on risk assessment, stating "Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk."
d) The Protocol also contains provisions on public participation and on the treatment of confidential information.
The Protocol requires Parties to promote and facilitate public awareness, education and participation on biosafety and to ensure that the public has access to information on LMOs that may be imported. In accordance with their laws and regulations, Parties are to consult the public in the decision-making process regarding LMOs, make the public aware of the results of decisions, and inform the public about access to the Biosafety Clearing-House.
Under the AIA procedure and other procedures specified by the Protocol, the Party of import will require information on LMOs and intended uses of LMOs to allow its regulatory authorities to make an informed decision on whether to allow the import of the LMO in question. The notifier must make all required information available to the regulatory authorities, but it may identify certain information that should be treated as confidential – i.e. that should not be divulged to third parties, including the public. Where the Party of import and the notifier disagree as to which information should be kept confidential, the party of import should consult the notifier prior to disclosure and the notifier may decide to withdraw the application. The Protocol specifies that the following information may never be treated as confidential: (a) the name and address of the notifier; (b) general description of the living modified organism; (c) summary of risk assessment; and (d) methods and plans for emergency response.
Once information is made available to the BCH in accordance with Article 20 and other provisions of the Protocol, it will not be considered confidential as the objective is to make this information publicly available
Reviewing decisions and the decision-making process:
a) A Party of import may, at any time, in light of new scientific information, review[6] and change a decision.
b) A Party of export or a notifier may also request the Party of import to review its decisions if there is a change in circumstances or new information becomes available.
Note:
Individual Parties may decide to subject specific LMOs to simplified procedures provided that adequate measures are applied to ensure safe intentional transboundary movement of LMOs in accordance with the Protocol’s objectives. Where it opts to do this, a Party must specify in advance to the BCH cases in which import of an LMO to it may take place at the same time as the transboundary movement is notified to it, and imports of LMOs to it that it has decided to exempt from the AIA procedure.[7].
Exceptions to the AIA procedure:
The Protocol’s AIA procedure does not apply to:
(i) LMOs in transit;[8]
(ii) LMOs destined for contained use[9] in the Party of import;
(iii) LMOs intended for direct use as food or feed or for processing (LMOs-FFP).[10]
Nonetheless, Parties do have the right to regulate such transboundary movements if they wish. A Party should make available to the BCH any decision it takes regarding the transit through its territory of a specific LMO.
[1] “Preamble CPB” CBD http://www.cbd.int/biosafety/articles.shtml?a=cpb-00
[2] “Objective ” CBD, CPB, Art 1 http://www.cbd.int/biosafety/articles.shtml?a=cpb-01
[3] “Decision procedure” CBD, CPB, Art 10, http://www.cbd.int/biosafety/articles.shtml?a=cpb-10
[4] “Procedure for LMO’s intended for direct use as FFP” CBD, CPB, Art 11.8 http://www.cbd.int/biosafety/articles.shtml?a=cpb-11
[5] “Risk assessment” CBD, CPB, Annex III http://www.cbd.int/biosafety/articles.shtml?a=cpb-43
[6] “Review of Decisions “ CBD, CPB, Art 12. http://www.cbd.int/biosafety/articles.shtml?a=cpb-12
[7] “Simplified procedure” CBD, CPB, Art 13. http://www.cbd.int/biosafety/articles.shtml?a=cpb-13
[8] “Transit and contained use” CBD, CP Art 6(1). http://www.cbd.int/biosafety/articles.shtml?a=cpb-06
[9] “Use of terms” CBD, CPB, Art 3 and Art 6(2). http://www.cbd.int/biosafety/articles.shtml?a=cpb-03
[10] “LMOs-FFP” UNEP-GEF Biosafety projects, An introduction to the Cartagena protocol on Biosafety.