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
contributionsnecessary 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
ofthe 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
andurges 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
tothe 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 declarethat 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 declarethat this transboundary
movement/shipment is in conformity with the requirements of the
Cartagena Protocol applicable to the exporter.
Signature of
exporter___________________________________________________ | Date___________ |
Notes:
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.