Biosafety Protocol takes bold moves
International regulation of the trade in genetically engineered organisms took a vital step forward when governments adopted several measures at the first ever Meeting of the Parties (MOP 1) to the Cartagena Protocol on Biosafety held in Kuala Lumpur, Malaysia.
By Martin Khor & Lim Li Lin
THE Meeting of the Parties (MOP 1) ended on 27 February with the adoption of 10 decisions on issues ranging from information-sharing and finance to the handling of living modified organisms (LMOs). (LMOs is the term used in the Protocol for what is commonly known as genetically modified organisms or genetically engineered organisms.)
When Malaysian Minister of Science, Technology and the Environment, Datuk Law Hieng Ding, who chaired the meeting, used the gavel for the last time after three weeks of negotiations on biodiversity and biosafety, there was some satisfaction that progress, however modest, had been made to implement the Protocol.
These gains were largely due to the fact that none of the Miami Group (a negotiating group of some of the major exporters and producers of genetically engineered organisms) are currently Parties to the Protocol. During the MOP, although the views of the non-Parties were considered, priority was given to Parties to the Protocol in drafting proposals and in the negotiations on the text of decisions for adoption.
For many years now there has been growing concern about the potential health, environmental and socio-economic risks posed by genetically engineered crops and food.
Whilst the biotech industry claims that the process and products from genetic engineering are safe, many governments and environmental and consumer groups have asked for more information about genetically engineered products and for action to regulate them.
After years of hard negotiations, the Biosafety Protocol came into force last September, and Malaysia hosted the first formal meeting of the 87 countries that have joined it.
Three of the most important decisions adopted by MOP 1 were on:
* Measures for handling, transporting, packaging and identifying LMOs, in line with Article 18 of the Protocol;
* Establishing compliance procedures and mechanisms for the Protocol; and
* Establishing an expert working group on liability and redress in the context of the Protocol.
Identification documents
Under Article 18 of the Protocol, countries shall take measures to require that LMOs that move across borders are handled, packaged and transported safely. The aim is to avoid adverse effects on biodiversity and risks to human health.
For the first time, the MOP has decided on the documentation that should accompany three categories of LMOs: firstly, those that are used as food or feed or for processing; secondly, those that are for ‘contained use’ (mainly in laboratories); and thirdly, those for introduction into the environment (such as genetically modified seeds for planting).
For the first category, documents should clearly identify that the shipment may contain LMOs for direct use as food, feed or for processing and not intended for introduction into the environment.
The documents should include the common, scientific and commercial names of the LMOs, the transformation event code or its unique identifier code (see box) to establish clearly the identity of the LMOs and any unique identification.
An expert group was set up to elaborate detailed requirements of identification of the LMOs under the first category, and report to the next MOP in 2005. The above measures are thus interim, and countries are requested or urged to take them now.
An important step forward was that the decision recognised that national legislation can require that the LMOs for food, feed or for processing are identified as such in the accompanying documentation with no ambiguity, when they are shipped from one country to another under the procedures of the Protocol.
For the second category of LMOs, documents accompanying them should clearly identify the LMOs by specifying their common and scientific names, and that they are destined for contained use. Additionally their commercial names and new and modified traits and characteristics may be included. Significantly, this information includes the transformation event(s), risk class, how they are to be used, and their unique identification.
For the third category, the documents should clearly identify them as LMOs by describing their names and traits (including transgenic traits such as transformation events or unique identification). Additionally their commercial name, risk class and the required approval permit for import under the Protocol may be included.
The documentation of LMOs under categories two and three must also specify any requirements for safe handling, storage, transport and use under existing international instruments, as well as domestic regulations and any agreement between the exporter and importer.
The names and addresses of the exporters and importers and the contact point for more information (including in case of emergencies) should also be provided in the documents in all three categories.
Compliance regime
On the compliance issue, MOP 1 had an intense week-long debate on how to deal with countries that do not comply with their obligations under the Protocol. The European countries were especially keen to get a strong compliance regime so that countries would take their obligations seriously.
The MOP eventually established some compliance procedures and mechanisms.
A Compliance Committee was set up, comprising 15 persons, three from each of five regional groupings. Committee members shall serve objectively and in a personal capacity. MOP 1 confirmed the members from Iran, Malaysia, Tonga, Mexico, Colombia, Barbados, Ethiopia, Cameroon, Mali, Hungary, Denmark, Norway, Switzerland, among the 15 countries.
The Committee, which will meet twice a year, will receive cases submitted to it of non-compliance. It will identify circumstances and causes of these cases, provide advice to the concerned Party to assist it to comply, review general compliance issues, take measures or make recommendations to the MOP.
A Party complained against has three to six months to respond, and the Committee will consider the views of both the Parties making and receiving the submission. The Committee can then take measures including giving advice or assistance to the Party and to develop a compliance action plan with a timeframe, ask the Party to submit progress reports, and make reports on efforts made by the Party to the MOP.
In turn, the MOP can decide on taking the following measures: provide assistance, technology transfer, training and capacity-building measures; issue a caution; have the cases on non-compliance published; or take other measures (to be decided at the Protocol Parties’ third meeting) in the case of repeated non-compliance.
Liability and redress
The issue of liability and redress was perhaps the most important for developing countries, with these countries (especially those from Africa) pressing for MOP 1 to adopt a strong and clear mandate to begin negotiations on an international regime.
They argued, in general, that in the event of accidents or incidents where LMOs cause damage to farmers’ crops, the environment or human health, there should be a legally binding regime to determine who is responsible and how redress or compensation can be made to the victims and for the harm done.
During the negotiations of the Biosafety Protocol itself, the issue had been so divisive that in the end, the compromise was to insert a provision in the Protocol that requires MOP 1 to take a decision on a process to elaborate international rules and procedures on liability and redress.
The MOP eventually decided to set up a working group of experts on liability and redress which will meet before next year’s Meeting.
It will analyse potential and actual damage scenarios of concern in order to identify situations for which international rules may be needed, and analyse how international rules and procedures on liability and redress can be applied to the damage scenarios.
It will also elaborate options for rules and procedures, including definition, nature and scope of damage, valuation of damage to biodiversity and human health, threshold of damage, causation, channelling of liability, roles of Parties of import and export, standard of liability, mechanisms of financial security and standing or right to bring claims.
The working group will meet five times and propose international rules and procedures on liability and redress in a final report in 2007. The MOP will then make a decision.
Besides the measures taken on these three issues, MOP 1 also took decisions on seven other issues, including capacity building, a medium-term work programme, information sharing and the biosafety clearing house, budget and other financial issues.
Delegates to the meeting appeared to be rather satisfied with the progress made at MOP 1.
Dr Tewolde Egziabher, a leading African scientist who is also head of the Ethiopian delegation and coordinator of the Africa Group, said he was especially pleased with the progress on liability and redress, an issue which for years the developing countries had been pushing for but which the developed countries had been opposing.
‘Even at the start of the Kuala Lumpur meeting, the developed countries were stalling on this issue, but in the end we were able to prevail on them. Besides the Africa Group, I must credit Malaysia for being very active among the developing countries for this.’
He added that the liability issue was critical as it was important that developing countries be able to be compensated if their farms, environment or human health were to be adversely affected by imported LMOs.
An international liability regime would also cause the private sector to be more careful and cautious in their activities relating to LMOs.
Tewolde was also happy that the Protocol would have a relatively strong compliance mechanism, unlike many other multilateral environment agreements. ‘With such a mechanism, it would be more difficult for Parties to shirk their obligations.’
Regarding the ‘Article 18 measures’, Tewolde said the MOP 1 decision makes it easier for countries to insist that imported products containing LMOs be labelled.
He noted, however, that most of the leading exporters of genetically engineered products are not members of the Protocol and thus are not obliged to follow its rules.
Nevertheless, the decision at MOP 1 would make it easier for importing countries to insist that the imports containing LMOs be accompanied by proper documentation, even from the countries that are non-Parties.
Tewolde added that the MOP 1 decision on LMOs for food, feed or processing only covers interim measures but it was the basis for a more detailed process to develop a lasting system for the handling and transport of LMOs.
‘Biosafety is important for African and other developing countries in order to protect agricultural and animal biodiversity,’ he said. If there is unintended contamination by genetically modified substances, it can affect crop diversity, agricultural productivity as well as human health.
‘I am happy the Biosafety Protocol is moving from rules to measures and action, but although we made good progress in Kuala Lumpur, the challenges are very big and there’s much more to be done.’
Martin Khor is Director of the Third World Network, and Lim Li Lin is a researcher with TWN.
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MOP 1 – What came out of it and what lies ahead
By Lim Li Lin
Decisions and recommendations of MOP 1
1. Procedures and mechanisms for facilitating decision-making by Parties of import (Article 10, paragraph 7)
2. Capacity building (roster of experts)
3. Capacity building
4. Consideration of other issues necessary for the effective implementation of the Protocol (e.g. Article 29, paragraph 4)
5. Mid-term programme of work for the Conference of the Parties serving as the Meeting of the Parties to the Biosafety Protocol (from the second to the fifth meetings)
6.Information-sharing and the Biosafety Clearing House (Article 20)
7.Guidance to the financial mechanism (recommendation from MOP 1, adopted by to COP 7)
8. Establishment of an open-ended ad hoc working group of legal and technical experts on liability and redress in the context of the Protocol
9.Programme budget for the distinct cost of the Secretariat services for and the biosafety work programme of the Cartagena Protocol for the biennium 2005-2006
10. Establishment of procedures and mechanisms on compliance under the Cartagena Protocol on Biosafety
11. Handling, transport, packaging and identification of living modified organisms (Article 18)
Substantive work of MOP 1
Plenary (Chaired by Datuk Law Hieng Ding, Minister of Science, Technology and the Environment, Malaysia)
* Decision procedure (Article 10, paragraph 7)
* Monitoring and reporting (Article 33)
* Guidance to the financial mechanism (Article 28, paragraph 5, Article 22)
– a regionally balanced Friends of the Chair group was set up, chaired by Linda Brown (UK)
* Medium-term programme of work of the Conference of the Parties to the Convention on Biological Diversity serving as the Meeting of the Parties to the Protocol
– a Friends of the Chair group was established, co-chaired by Birth Ivars (Norway) and Ernesto Cespedes (Mexico)
Working Group I (Chaired by Fran!ois Pythoud, Switzerland)
* Information sharing and the Biosafety Clearing House
* Handling, transport, packaging and identification (Article 18)
– a Contact Group was set up, chaired by Veena Chhotray (India) and Eric Schoonejans (France), to address the issues arising from operative paragraphs 1, 3 and 5 of the draft decision on Article 18 (2) (a)
– a Friends of the Chair group was further set up comprising one representative each of the Central and Eastern European region, Brazil, Malaysia, Uganda and the European Community
* Consideration of other issues necessary for the effective implementation of the Protocol (e.g. Article 29, paragraph 4)
Working Group II (Chaired by Ambassador Philemon Yang, Cameroon)
* Capacity building, including roster of experts, operational guidelines for the coordinating mechanism, indicators for monitoring implementation of the Action Plan
* Compliance (Article 34)
– an open-ended Contact Group on compliance was set up, chaired by Jrg Bally (Switzerland) and Rawson P Yonazi (United Republic of Tanzania)
– a Friends of the Co-chairs group was further set up comprising Brazil, Colombia, Ethiopia, India, Ireland, Japan, Malaysia, Norway and South Africa
* Liability and redress (Article 27)
– a Friends of the Chair group coordinated by Rene Lefeber (Netherlands) was set up comprising Colombia, Ethiopia, Ireland and Malaysia
Meetings to be held before MOP 2
Liability and redress
1. Technical Group of Experts on Liability and Redress
2. Open-ended Ad Hoc Working Group of Legal and Technical Experts on Liability and Redress
Handling, transport, packaging and identification
1. Workshop of capacity building and exchange of experiences on Article 18 (2)
2. Open-ended Technical Expert Group on Article 18 (2) (a)
Compliance
1. Meeting of the Compliance Committee (to develop rules of procedure)
Capacity building
1. Coordination mechanism meeting for representatives of academic and research institutions actively involved in education, training and research programmes in biotechnology and biosafety
Other meetings to be held in 2005
1. Biosafety Clearing House advisory meetings
2. Biosafety Clearing House Technical Expert meetings
3. Capacity building liaison group meetings (two per year)
4. Coordination mechanism meetings on capacity building
5. Compliance committee meetings (two per year)
6. Regional meetings for the Biosafety Protocol (four per year)
7. Regional capacity building meetings on Article 18 (four per year)
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Unique identification
By Lim Li Ching
THE documentation required for the three categories of LMOs – for food or feed or for processing; for ‘contained use’; and for introduction into the environment – should include, where available, the unique identification or unique identifier code of the LMO. The unique identifier should be a key to accessing information in the Biosafety Clearing House (BCH); the BCH’s pilot phase is already searchable using unique identifier codes.
A unique identifier is basically a code that allows one to find more detailed information in a database. Such a system can be easy to use, but is only as good as the information in the database. A good unique identification system, by providing access to full biosafety information and risk assessments, can help enable traceability, surveillance, post-market monitoring, risk management, remedial actions and assignment of liabilities in case of contamination and damages.
Part C of the MOP 1 decision on Article 18 on unique identification system(s) encourages the use of the Organisation for Economic Co-operation and Development (OECD) Unique Identifiers for Transgenic Plants, without prejudicing the development and applicability of other systems.
The OECD Unique Identifiers are alphanumeric codes based on, and unique to, a transformation event. These act as a ‘key’ to unlock or access information in the OECD’s database of transgenic products that have been approved for commercial application, as well as in interoperable systems such as the BCH. The information in the database includes the applicant’s name, the common, scientific and commercial names of the LMO, the transformation event(s), and the modified trait(s) and gene(s). Some decisions of various authorities are also available; however, some web-links were inactive at the time of writing and the information incomplete.
The OECD Unique Identifiers are already in use, with the codes designated by the applicant (e.g. the company) to the national authority, for their products. On 16 January 2004, Commission Regulation (EC) No 65/2004 on ‘establishing a system for the development and assignment of unique identifiers for genetically modified organisms’, which are intended for placing on the market, entered into force. This regulation puts in place the EU’s traceability system and completes the EU regulation on traceability and labelling of genetically modified food and feed. The format of the unique identifier required under the EU regulation is the same as the OECD format. Applicants should develop the unique identifier following consultation of the OECD database and the BCH.
While the OECD Unique Identifiers for Transgenic Plants are a good step forward in developing the unique identification system(s) under the Biosafety Protocol, such a system could be further improved by also including the event-specific molecular signature that defines the transgenic variety. This signature would consist of the complete molecular characterisation of the transgenic insert(s) in terms of the structure and function of sequences in the insert(s) and location(s) in the host genome. It would also be important to require the applicant to deposit a sample of the transgenic organism with the competent authority, to enable appropriate verification.
The MOP 1 decision further recognises that a unique identification system is required for genetically modified micro-organisms and animals (the EU regulation already applies to micro-organisms and animals). Furthermore, the expert group established to elaborate detailed requirements of identification of LMOs for food or feed or for processing is to consider the extent and modality of using unique identifiers.
Lim Li Ching is a researcher with Third World Network and the Institute of Science in Society.