Cartagena Protocol on Biosafety

Submission of the Government of Australia

Request for views and information regarding issues relevant to paragraph 2(a) of Article 18 of the Cartagena Protocol on Biosafety

Australia thanks the Executive Secretary for the opportunity to offer its views on issues relevant to paragraph 2(a) of Article 18 of the Cartagena Protocol on Biosafety, as set out in notification SCBD/BS/CS/WDY/jh/42384.  Australia notes that the Open-Ended Technical Experts Group (Open-Ended TEG) should take into account the extensive work already undertaken on this issue, as outlined in the chapeau of the decision BS-I/6 taken at the first meeting of the Parties (MOP-1). 

Australia supports the outcomes of the Technical Experts Group of March 2002 and believes this document should form the basis for further work.  However, it should be noted that these comments do not represent a view that such documentation is necessary to achieve the objectives of the Protocol.

Australia notes that very few countries have implemented obligations under the Protocol, and in particular in relation to documentation requirements for LMOs-FFP.  Discussion of such issues as unique identification, co-mingling of LMOs with non-LMO shipments and any possible relevance of Article 17 (Unintentional movements) is premature.

(a)   Information on experience, if any, in the implementation of the requirements of the first sentence of paragraph 2(a) of Article 18;

Australia is not a party to the Protocol and therefore has not implemented these requirements.  However, implementation of these requirements by parties to the Protocol that also import Australian agricultural commodities mean that Australian agricultural exporters must comply with the requirements of the Protocol as transposed into the domestic law of these parties in order to gain market access. 

Australia views the requirements of the first sentence to be simple, practical and not unduly burdensome or costly to implement or understand, for the importer and exporter.

(b)     Views regarding the detailed requirements referred to in the second sentence of paragraph 2(a) of Article 18, including specification of the identity of the living modified organisms (LMOs) that are intended for direct use as food or feed, or for processing (FFP) (whether the extent of information should include taxonomic name, the gene modification inserted and traits or genes changed); threshold levels in the case of co-mingling of LMOs with non-LMOs; and possible linkages of the issue with Article 17 of the Protocol; the "may contain" language; and any unique identification;

Australia notes that the decision that sets out the terms of reference of the Open-Ended TEG ranked the terms of reference by priority, with (a), (b) and (c) being of a higher priority than (d) and (e).  Australia requests that the Executive Secretariat preserve this priority ranking when preparing its synthesis of information and views, for consideration by the Open-Ended TEG.

Australia has prepared a submission that uses the terms of reference of the Open-Ended TEG, as set down in the decision taken at MOP-1, as a framework for comments. 

The Open-Ended Technical Expert Group shall:

1. Examine the issues of specifying the identity of living modified organisms that are intended for direct use as food or feed, or for processing and unique identification mentioned in the second sentence of paragraph 2 (a) of Article 18 in relation to the "may contain" language of the first sentence of the same paragraph, and any other issues that may be relevant to the elaboration of the detailed requirements of identification of living modified organisms that are intended for direct use as food or feed, or for processing, including:

(a) The documentation to accompany living modified organisms that are intended for direct use as food or feed, or for processing for the purpose of Article 18, paragraph 2 (a);

(b) The information provided in the accompanying documentation;

Australia supports documentation requirements that are:

·               Minimally disruptive to trade by taking account of and being consistent with other international obligations, including WTO agreements;

·               Not unduly burdensome or costly to implement or understand, from both the import and export perspective;

·               Designed to meet the requirements explicitly set out in the Protocol and do not go beyond these requirements;

·               Consistent with and avoid duplication of on-going work within existing international organizations, such as Codex Alimentarius Commission, International Plant Protection Convention and the Office International des Epizooties – which develop standards on the basis of sound science.

As such, Australia supports measures that would be able to be incorporated into existing documentation.  It should be noted that exports of Australian grain are already accompanied by a number of documents – including bills of lading, Sanitary and Phytosanitary certificates, certificates of origin, banking documents, quality documents, stowage documents and always a commercial invoice.  Australia believes that the existing documentation is sufficient to convey information requirements set down by the text of the Protocol for LMO-FFPs. 

In that regard, Australia draws attention to the Executive Secretary’s note prepared pursuant to a request by the WTO Committee on Trade and Environment (WT/CTE/W/235) in Special Session presenting an overview of decisions at MOP1 of relevance to the WTO.  Australia particularly notes the Executive Secretary’s characterization of the Decision BS-I/6 in relation to the documentation accompanying the transboundary shipment of LMOs:  “In order to avoid unnecessary burden to exports, the first meeting of the Parties, in decision BS-I/6, decided to integrate identification requirements for LMOs for food, feed, and processing in commercial invoices or other relevant existing documentation systems.”

Australia views that the first sentence of Article 18.2(a) provides for sufficient information to be placed on shipping documentation for fulfilling the objectives of the Protocol.  It is important to recall that the key source of information on LMOs under the Protocol will be the Biosafety Clearing House (BCH).  It is not intended that shipping documentation substitute for, or duplicate, the detailed information provided through the BCH. 

(c) The extent and modality of using unique identifiers; and, if possible,

Australia is of the view that the requirement for unique identifiers has yet to be demonstrated.  As Article 18.1 specifies “necessary measures” rather than “measures”, it remains to be demonstrated that unique identifiers are “necessary measures”. Therefore, the case for unique identifiers should be put forward and discussed prior to the Open-Ended TEG considering the extent and modality of using unique identifiers to achieve the objectives of the Protocol. 

The second sentence of 18.2(a) is procedural in nature.  ‘[S]pecification of their identity and any unique identification…’ does not necessarily mean the use of unique identifiers.  The question of whether unique identifiers are a “necessary measure” in this context is still open and to be resolved.  Resolving the question needs to take into account countries’ experience in implementing the Protocol and should be attempted via a step-wise approach:

·        Assemble data that demonstrates the requirement for documentation identifying LMOs-FFP that are intended to undergo a transboundary movement

o       Assemble data that demonstrates how and in what circumstances documentation can assist in achieving the objectives of the Protocol

·        Discuss this data

·        Decide on whether identifying documentation is a “necessary measure”

·        Discuss different ways of meeting a “necessary measure”, including mechanisms that may already exist.

It should be noted that use of any documentation-based unique identifiers for intentional transboundary movements of LMOs-FFP needs to consider and resolve the following practical implementation issues:

·        As the text of the Protocol provides only for identification of those LMO varieties intended to be contained in a shipment, what would happen if the identified list were inaccurate or incomplete?

·        Is it envisaged that any unique identification be verified or subject to compliance or liability and redress measures?  If so, how?

Regarding the OECD unique identifier system, Australia notes that it is focused on LMO plants, does not cover LMO microbes, animals or viruses and therefore has insufficient scope for use in the Protocol.  Further, the veracity and robustness of the information is not guaranteed and the use of the system is not standardized. 

Australia believes that adapting or seeking to harmonize other identification systems that cover LMO animals, microbes and viruses with the OECD system would be cumbersome and inefficient.

In addition, applying the OECD unique identifiers for Article 18 2(a) is limited, as:

• The OECD work on unique identifiers is voluntary and at an early stage of development.

·           The use of unique identifiers is not standardised.

·           The veracity of the information on the unique identifier database is not guaranteed.

·           The range of products to which unique identifiers currently apply covers more than LMOs.  How would the difference in coverage be resolved?

·           There is no regulatory body that has considered adopting unique identifiers, nor administering their application or use.  The CBD and subsidiary bodies, such as those associated with the Protocol, are not an appropriate regulatory body for this task – nor should it take on this role, as such a role would entail the setting of standards in an area in which it lacks suitable expertise and would be better dealt with elsewhere.

·           The unique identifiers apply only to plants, whereas animal and micro-organisms are also within the scope of the Protocol.  Therefore, the unique identifiers have insufficient scope.

·           The use of unique identifiers would represent additional documentation and would be an additional cost on industry – without any gain for industry.

·           The format of use of unique identifiers is not decided. 

(d) Thresholds for adventitious or unintentional presence of LMOs that may be needed to trigger identification requirements;

Australia continues to hold the view that the text of the Protocol does not cover or apply to the adventitious or unintended presence of LMOs in non-LMO shipments as the text of Article 18.2a explicitly refers to LMOs intended for direct use as FFP.  Providing guidance on the documentation of a shipment of conventional grain in relation to any possible or potential adventitious presence of LMOs, for example, is not within the scope of the Protocol.

Appropriate international standards-setting bodies, such as the International Plant Protection Convention and Codex Alimentarius are undertaking relevant work on thresholds of LMOs in conventional commodity shipments.

(e) Review available sampling and detection techniques, with a view to harmonization.

The Open-Ended TEG should bear in mind that there currently exist a range of sampling and testing technologies that can be used to detect the presence of LMOs.  Each test has its own strengths and weaknesses.  Therefore, the method that is most suited for each LMO must be determined on a case-by-case basis.  There is considerable existing work in developing frameworks for harmonisation of tests for LMOs, such as the work of the Codex Committee on Methods and Analysis of Sampling.

(c)   Information on experience with the use of existing unique identification systems under the Protocol, such as the Unique Identifier for Transgenic Plants of the Organization for Economic Co-operation and Development.

See the comments made on unique identification in 1c above. 

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