. Handling, transport, packaging and identification of living modified organisms (Article 18)

Handling, transport, packaging and identification of living modified organisms (Article 18)

A. Paragraph 2 (a) of Article 18

The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety,

Noting the recommendations of the Intergovernmental Committee for the Cartagena Protocol on Biosafety at its third meeting regarding paragraph 2 (a) of Article 18,

Recognizing the difficulties involved in the efforts to arrive at common grounds by Intergovernmental Committee with regard to some of the issues encountered in relation to identification of living modified organisms for direct use as food or feed, or for processing,

Recalling the second sentence of paragraph 2 (a) of Article 18, which requires the Conference of the Parties serving as the meeting of the Parties to the Protocol to take a decision on the detailed requirements of those elements specified in the first sentence of the same paragraph, including specification of the identity of the living modified organisms in question and any unique identification, no later than two years after the date of entry into force of the Protocol,

Noting that any decision taken at this stage regarding the understanding and implementation of the requirements specified in the first sentence of paragraph 2 (a) of Article 18 would only be interim until the decision referred to in the second sentence of the same paragraph on the detailed requirements is taken,

Recalling that a Party to the Protocol may take a decision on the import of living modified organisms intended for direct use as food or feed, or for processing, under its domestic regulatory framework that is consistent with the objective of the Protocol,

1. Requests Parties to the Protocol and urges other Governments to take measures to require the use of a commercial invoice or other document required or utilized by existing documentation systems, as documentation that should accompany living modified organisms that are intended for direct use as food or feed, or for processing, for the purpose of identification by incorporating the information requirements of the first sentence of paragraph 2 (a) of Article 18, and the requirements established under paragraph 4 below, pending a decision on detailed requirements for this purpose by the Conference of the Parties serving as the meeting of the Parties to the Protocol, which could include the use of a stand-alone document;

2. Requests Parties to the Protocol and urges other Governments to take measures ensuring that documentation accompanying living modified organisms that are intended for direct use as food or feed, or for processing clearly identifies that the shipment may contain living modified organisms intended for direct use as food or feed, or for processing, and states that they are not intended for intentional introduction into the environment;

3. Further requests Parties to the Protocol and urges other Governments to take measures ensuring that the documentation accompanying living modified organisms that are intended for direct use as food or feed, or for processing, provides the details of a contact point for further information: the exporter, the importer, or any appropriate authority, when designated by a Government as the contact point;

4. Further urges Parties to the Protocol and other Governments to require that the documentation referred to in paragraph 1 above includes: (i) the common, scientific and, where available, commercial names, and (ii) the transformation event code of the living modified organisms or, where available, as a key to accessing information in the Biosafety Clearing-House, its unique identifier code;

5. Encourages Parties to the Protocol and other Governments to require exporters of living modified organisms that are intended for direct use as food or feed, or for processing under their jurisdiction to declare, in documentation accompanying transboundary movements known to intentionally contain living modified organisms that are intended for direct use as food or feed, or for processing, that the shipment contains living modified organisms that are intended for direct use as food or feed, or for processing, the identity of the living modified organism, and any unique identification, where possible;

6. Decides to establish an open-ended technical expert group on identification requirements of living modified organisms that are intended for direct use as food or feed, or for processing to assist the Conference of the Parties serving as the meeting of the Parties to the Protocol in taking the decision referred to in paragraph 2 (a) of Article 18 of the Protocol, on the basis of the terms of reference specified in the annex to this decision;

7. Requests Parties to the Protocol, other Governments and relevant international organizations to provide to the Executive Secretary by 30 June 2004:

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

(b) Their 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 that are intended for direct use as food or feed, or for processing (whether the extent of information should include taxonomic name, the gene modifications inserted and traits or genes changed); threshold levels in the case of co-mingling of living modified organisms with non-LMOs, and possible linkages of the issue with Article 17 of the Protocol; the "may contain" language; and any unique identification;

(c) Their experiences with the use of existing unique identification systems under the Protocol, such as the Unique Identifier for Transgenic Plants of the Organisation for Economic Co-operation and Development;

8. Requests the Executive Secretary to prepare a synthesis of the information and views referred to above, for the consideration of the open-ended technical expert group mentioned in paragraph 6 above, and to convene, subject to the necessary financial resources being made available, the meeting of the open-ended technical expert group, and to submit the report and draft decision of the group to the second meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

9. Urges developed country Parties and other donor Governments to make financial contributions necessary to facilitate the participation of experts from developing countries and countries with economies in transition in the open-ended technical expert group referred to in paragraph 6 above.

Annex

TERMS OF REFERENCE FOR THE OPEN-ENDED TECHNICAL EXPERT GROUP ON IDENTIFICATION REQUIREMENTS OF LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING

Taking into account the need for the Conference of the Parties serving as the meeting of the Parties to the Protocol to take a decision on the detailed requirements of identification of living modified organisms that are intended for direct use as food or feed, or for processing in accompanying documentation, including specification of their identity and any unique identification, no later than two years after the date of entry into force of the Protocol, and

Considering: (i) the report and recommendations of the Meeting of Technical Experts on the Requirements of Paragraph 2 (a) of Article 18; (ii) the Chair’s summary of Working Group I of the discussion regarding paragraph 2 (a) of Article 18 at the third meeting of the Intergovermental Committee for the Cartagena Protocol on Biosafety; (iii) the decision of the first meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol; and (iv) the information and views provided by Parties to the Protocol, other Governments and relevant international organizations in accordance with paragraph 7 of decision BS-I/6 A above,

Understanding that composition of the open-ended technical expert group shall be designed for effective participation, inclusiveness, transparency, and technical expertise relevant to the issues specified in this terms of reference, and that it will be composed of experts, nominated by Parties to the Protocol and other Governments and relevant international organizations, with technical expertise relevant to the issues specified in the terms of reference,

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;

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

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

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

2. Prepare a draft decision regarding issues mentioned in paragraph 1 above, for the consideration of the Conference of the Parties serving as the meeting of the Parties to the Protocol.

3. Complete its work in time for the Conference of the Parties serving as the meeting of the Parties to the Protocol to take this decision at its second meeting.

B. Paragraphs 2 (b) and 2 (c) of Article 18

The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety,

Noting the recommendations of the Intergovernmental Committee for the Cartagena Protocol on Biosafety at its third meeting regarding paragraphs 2 (b) and 2 (c) of Article 18 of the Cartagena Protocol on Biosafety,

1. Requests Parties to the Protocol and urges other Governments to take measures to ensure the use of a commercial invoice or other documents required or utilized by existing documentation systems, with consideration given to the formats outlined in the example templates annexed hereto, as documentation that should accompany living modified organisms for contained use and living modified organisms for intentional introduction into the environment of the Party of import, incorporating the information required under paragraphs 2 (b) and 2 (c) of Article 18 of the Protocol, as appropriate, with a view to fulfil the identification requirements of these paragraphs;

2. Requests Parties to the Protocol and invites other Governments to submit to the Executive Secretary, not later than six months prior to the third meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol, information on experience gained with the use of documentation referred to in paragraph 1 above, with a view to the future consideration of a stand-alone document, to fulfill the identification requirements of paragraphs 2 (b) and 2 (c) of Article 18, and requests the Executive Secretary to compile the information received and to prepare a synthesis report presenting options for stand-alone documentation for consideration by the third meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol;

3. Requests Parties to the Protocol and urges other Governments to take measures ensuring that documentation accompanying living modified organisms contains the following information and declaration:

(a) Living modified organisms for contained use (Article 18, paragraph 2 (b)):

(i) Clear identification as "living modified organisms" including common and scientific names of the organisms and as "destined for contained use";

(ii) The name and address of the consignee, and exporter or importer, as appropriate, including contact details necessary to reach them as fast as possible in case of emergency;

(iii) Any requirements for the safe handling, storage, transport and use of the living modified organisms under applicable existing international instruments, such as the United Nations Recommendations on the Transport of Dangerous Goods, the International Plant Protection Convention and the Organisation Internationale des Epizooties, domestic regulatory frameworks or under any agreements entered into by the importer and exporter. In the event that there is no requirement, indicate that there is no specific requirement;

(iv) Where appropriate, further information should include the commercial names of the living modified organisms, if available, new or modified traits and characteristics such as event(s) of transformation, risk class, specification of use, as well as any unique identification, where available, as a key to accessing information in the Biosafety Clearing-House;

(b) Living modified organisms for intentional introduction into the environment of the Party of import and any other living modified organisms within the scope of the Protocol (Article 18, paragraph 2 (c)):

(i) Clear identification as "living modified organisms" and a brief description of the organisms, including common and scientific name, relevant traits and genetic modification, including transgenic traits and characteristics such as event(s) of transformation or, where available and applicable, a reference to a system of unique identification;

(ii) Any requirements for the safe handling, storage, transport and use of the living modified organisms as provided under applicable existing international requirements, domestic regulatory frameworks, or under any agreement entered into by the importer and exporter. In the event that there is no requirement, indicate that there is no specific requirement;

(iii) The name and address of the exporter and importer;

(iv) The details of the contact point for further information, including an individual or organization in possession of relevant information in case of emergency;

(v) A declaration that the movement of the living modified organisms is in conformity with the requirements of the Cartagena Protocol on Biosafety applicable to the exporter;

(vi) Where appropriate, further information should include the commercial name, risk class, and import approval for the first transboundary movement of living modified organisms;

4. Invites Parties, other Governments and relevant international organizations to make available to the Executive Secretary, not later than six months prior to the date of the second meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol, information regarding their experience, if any, in the implementation of the requirements of paragraphs 2 (b) and 2 (c) of Article 18;

5. Requests the Executive Secretary to prepare a synthesis report of information received from Parties, other Governments or relevant international organizations in accordance with paragraph 4 above and submit the report to the second meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol.

C. Unique identification system(s)

The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety,

Mindful of the consideration of the issue of unique identification in the context of paragraph 2 (a) of Article 18 by the open-ended technical expert group established pursuant to paragraph 6 of decision BS-I/6 A above,

Recognizing the need for harmonized unique identifier codes for facilitating access to relevant information that may be available in the Biosafety Clearing-House regarding living modified organisms subject to transboundary movement,

Welcoming the development and adoption of the Organisation of Economic Co-operation and Development (OECD) Guidance for the Designation of a Unique Identifier for Transgenic Plants,

Recognizing that other unique identification systems may be developed, and that a unique identification system is also required for genetically modified micro-organisms and animals,

1. Invites Parties and other government to take measures to apply, as appropriate, the OECD Unique Identifiers for Transgenic Plants to living modified plants under the Protocol, without prejudice to the possible development and applicability of other systems;

2. Requests the Executive Secretary to develop or maintain, in the Biosafety Clearing-House, a register of unique identification codes to ensure harmonisation of such codes by all users;

3. Encourages the Organisation for Economic Co-operation and Development and other organizations involved in the development of unique identification systems for living modified organisms to initiate or enhance their activities towards the development of a harmonized system of unique identifiers for genetically modified micro-organisms and animals.

D. Capacity-building

The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety,

Recognizing the urgent need to address the critical capacity-building requirements of developing country Parties, in particular the least developed and small island developing States among them, and Parties with economies in transition, regarding the implementation of the requirements of Article 18, in particular the documentation requirements under paragraph 2;

Requests the Executive Secretary to convene, prior to the meeting of the open-ended technical expert group mentioned in paragraph 6 of decision BS-I/6A above, subject to the necessary financial resources being made available, a workshop on capacity-building and exchange of experiences on the safe handling, transport, packaging and identification of living modified organisms, as related to the implementation of paragraph 2 of Article 18 of the Protocol.

Annex

EXAMPLES OF INTEGRATION OF INFORMATION REQUIREMENTS INTO EXISTING DOCUMENTATION

A. Blank example of template for Article 18.2 (b) of the Cartagena Protocol

COMPANY OR INSTITUTION LETTERHEAD

Invoice

Date _________________________

	EXPORTER	IMPORTER/CONSIGNEE	CONTACT POINT Exporter ¨ Importer/Consignee ¨ Other ¨
COMPANY OR INSTITUTION
CONTACT PERSON
STREET
CITY, POSTAL CODE
COUNTRY
PHONE; FAX
EMAIL

Shipping details	Shipper reference number	Shipper contact details

Item	Amount	Weight/Volume	Description	Value
			Living modified organisms:
			Destined for contained use
			Name of the organisms
			Intended use e.g. research, others

ANY REQUIREMENTS FOR SAFE HANDLING, STORAGE, TRANSPORT AND USE

· As provided under applicable existing international requirements, · As provided under domestic regulatory framework, if any, · Any other requirements agreed to by the importer and exporter, or · In the event there is no requirement, indicate that there is no specific requirement

B. Example 1 of template for Article 18.2 (b) of the Cartagena Protocol

COMPANY OR INSTITUTION LETTERHEAD

Invoice

Date _________________________

	EXPORTER	CONSIGNEE	CONTACT POINT Exporter ¨ Consignee ¨ Other ¨
COMPANY OR INSTITUTION	XXXX	YYYY
CONTACT PERSON
STREET
CITY, POSTAL CODE
COUNTRY
PHONE; FAX
EMAIL

Shipping details	Shipper reference number	Shipper contact details

Item	Amount	Weight/Volume	Description	Value
1	bag	50 g	Living modified organisms:	none
			Destined for contained use
			Papaya
			Research material
			seeds, PRSV (Papaya Ring Spot Virus) resistant

ANY REQUIREMENTS FOR SAFE HANDLING, STORAGE, TRANSPORT AND USE

Should only be used in registered facilities

C. Example 2 for Article 18.2 (b) of the Cartagena Protocol

Shippers Declaration of Dangerous Goods
Shipper:	Name				Air Waybill No:		123456789
	Company or Institution
	Address				Page 1 of 1 Pages
					Shipper's Reference Number			sso
	Phone number					(optional)
Consignee :					Contact Point		Shipper	¨	Consignee ¨
	Company or Institution						Other	¨
	Contact Person				Company or Institution
	Street, City				Contact Person
	Postal Code, Country				Street, City
	Phone, Fax				Postal Code, Country
	Email				Phone, Fax
Two Completed and signed copies of this Declaration must
be handed to the operator					WARNING
TRANSPORT DETAILS
			Airport of Departure		Failure to comply in all respects with the applicable
This shipment is within the					Dangerous Goods Regulations may be in breach of
limitations prescribed for:					the applicable law, subject to legal penalties. This
delete non-applicable)					Declaration must not, in any circumstances, be
PASSENGER		CARGO			completed and/or signed by a consolidator, a
AND CARGO		AIRCRAFT			forwarder or an IATA cargo agent.
AIRCRAFT		ONLY
Airport of Destination:					Shipment Type: (delete non-applicable)
					NON-RADIOACTIVE		RADIOACTIVE

NATURE AND QUANTITY OF DANGEROUS GOODS
Dangerous Goods Identification						Quantity and Type
		Class or	UN or	Packing	Subsidiary			Packing
Proper-Shipping Name		Division	ID No.	Group	Risk	of Packing		Instruction	Authorization
Infectious Substances		6.2	UN 2814			1 Fiberboard Box		602
Affecting Humans						("Safe-T-Pak")
HIV gene bank in E.coli K12
						x 25.0 mL
Living modified organisms
Dry Ice		9	UN1845	III		1 x 12.4Kg		904
						1 Overpack Used
Additional Requirements for Safe Handling, Storage, Transport and Use
Prior Arrangements As Required By The IATA Dangerous Goods Regulations 1.3.3.1 Have
Been Made.								IATA/ICAO USED
This material is for contained use only in a certified Safety Level 2 Facility
			24 hr. Emergency Contact Telephone No.					Chemtrec 800/424-9300
I hereby declare that the contents of this consignment are fully and							Name/Title of Signatory
accurately described above by the proper shipping name and are							Name/Title of Signatory
classified, packaged, marked and labeled/placarded, and are in all							Place and Date
respects in proper condition for transport according to applicable							City, State, Country		Date
international and national governmental regulations.							Signature
							(see warning above)

D. Blank Example Template for Article 18.2 (c) of the Cartagena Protocol

COMPANY OR INSTITUTION LETTERHEAD

Invoice

Date _________________________

	EXPORTER	IMPORTER	CONTACT POINT Exporter ¨ Importer ¨ Other ¨
COMPANY OR INSTITUTION
CONTACT PERSON
STREET
CITY, POSTAL CODE
COUNTRY
PHONE; FAX
EMAIL

Shipping details	Shipper reference number	Shipper contact details

Item	Amount	Weight/Volume	Description	Value
			· Living modified organism
			· Brief Description of the organisms including category, name, relevant traits including transgenic traits and characteristics such as event(s) of transformation
			· Where available and applicable: v Reference to a system of identification such as: o Harmonized code such as unique identifier o Notification under AIA o Final decisions o Notifications to the BCH v Other requirements in accordance with the regulatory status of the LMO in the Party of import

ANY REQUIREMENTS FOR SAFE HANDLING, STORAGE, TRANSPORT AND USE

· As provided under applicable existing international requirements, · As provided under domestic regulatory framework, if any, · Any other requirements agreed to by the importer and the exporter, · As provided under the advance informed agreement procedure if applicable, or · In the event there is no requirement, indicate that there is no specific requirement.

I declare that this transboundary movement/shipment is in conformity with the requirements of the Cartagena Protocol applicable to the exporter.

Signature of exporter___________________________________________________

Date___________

E. Example 1 Template for Article 18.2 (c) of the Cartagena Protocol

COMPANY OR INSTITUTION LETTERHEAD

Invoice

Date _________________________

	EXPORTER	IMPORTER	CONTACT POINT Exporter ¨ Importer ¨ Other ¨
COMPANY OR INSTITUTION	XXXX	YYYY
CONTACT PERSON
STREET
CITY, POSTAL CODE
COUNTRY
PHONE; FAX
EMAIL

Shipping details	Shipper reference number	Shipper contact details

Item	Amount	Weight/Volume	Description	Value
4	Bags	1 Kg	Living modified organism:	none
			Rice, resistance against Xanthomonas campestris pv. Orizae , RI323, 327, 432 &726
			Permit RICE3434-02 for experimental release
			Research material

ANY REQUIREMENTS FOR SAFE HANDLING, STORAGE, TRANSPORT AND USE

· See permit RICE3434-02

I declare that this transboundary movement/shipment is in conformity with the requirements of the Cartagena Protocol applicable to the exporter.

Signature of exporter___________________________________________________

Date___________

F. Example 2 Template for Article 18.2 (c) of the Cartagena Protocol

COMPANY OR INSTITUTION LETTERHEAD

Invoice

Date _________________________

	EXPORTER	IMPORTER	CONTACT POINT Exporter ¨ Importer ¨ Other ¨
COMPANY OR INSTITUTION	XXXX	YYYY	ZZZZ
CONTACT PERSON
STREET
CITY, POSTAL CODE
COUNTRY
PHONE; FAX
EMAIL

Shipping details	Shipper reference number	Shipper contact details

Item	Amount	Weight/Volume	Description	Value
1	1000 bags	50’000 pounds	Living modified organism:	22’000 €
			Soybean WSD 432, high oleic acid, HOA
			Permit #GM21345/2002 for planting OECD UI: BI-ABC891-8 1 /
			Commercial seeds material

ANY REQUIREMENTS FOR SAFE HANDLING, STORAGE, TRANSPORT AND USE

NO SPECIFIC REQUIREMENT

I declare that this transboundary movement/shipment is in conformity with the requirements of the Cartagena Protocol applicable to the exporter.

Signature of exporter___________________________________________________

Date___________

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Notes:

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1 / See OECD Guidance for the Designation of Unique Identifier for Transgenic Plants, 2002 – Key to accessing databases that provide additional information on the LMO.