Theme 1: Existing standards and standard-setting bodies

My name: Adel A. Soliman, Biosafety project coordinator Assistant, Egypt

If we look to the standards set by CODEX ALIMENTARIUS commission OR the INTERNATIONAL PLANT PROTECTION Convention, we will find out they are not legally binding for both CODEX and IPPC parties. OIE also is only focuses on Animal health not human. Therefore, we must be aware that the lack of standards for LMOs shipments will be a barrier to trade especially, if we know that at this time many of the shipments move between the countries without specific criteria or standards.
These standards should be set by a group of the international experts in different LOMs related field as well as the members of the conference of parties of the Biosafety protocol. There must also be a maximum for such shipments.

I agree with Adel that the lack of standards for LMOs shipments will be a barrier to trade , since national standards may differ and thus create difficulties for suppliers of the commodity.However,the  most serious consequence is the threat to human health for countries that may not have capacity to develop their own standards.Hence the need to have internationally binding standards can not be overstressed.

I would like to shortly describe the situation in the European Union, where the international rules on transport of dangerous goods for inland modes (road, rail and inland waterways) are compulsory for all transport of dangerous goods. These rules are, for a large part, based on the United Nations Sub-Committee's Model Regulations, but they are mode specific and contain also requirements for the construction of vehicles.

For road and inland waterways the United Nations Economic Council for Europe (UNECE) hosts the work on developing the rules for the safe - and nowadays also secure - transport of dangerous goods. The road code is commonly known as "ADR" and the inland waterways code "ADN". This work goes back to 1957, when ADR was agreed in Geneva.

For rail transport there is a organisation called Intergovernmental Organisation For International Carriage By Rail (OTIF), which hosts the work for RID, which is the acronym for the "Regulations concerning the International Carriage of Dangerous Goods by Rail".

The work of these two organisations is coordinated by a Joint Meeting between UNECE and OTIF.

In the European Union, where we wish not to make difference between national and cross border transport, the international rules mentioned above are made legally compulsory for all transport of dangerous goods via a Directive that was updated last year (2008/68/EC on the inland transport of dangerous goods).

Sorry about that rather long introduction, but I wished to highlight that for land transport in Europe there are established a detailed rules that are maintained continuously: the three sets of rules are updated every two years, the current ones are in force 2009-2011. There are, every year, more than ten meetings of these working parties, lasting between one and two weeks. Furthermore, a large number of ad-hoc working groups are established with a special mandate to look at some specific issues.

This was just to highlight that there is a working system to develop rules on the transport of dangerous goods. Currently there is a UN number 3245 for genetically modified micro-organisms and genetically modified organisms. When a shipment is classified as UN3245, certain specific rules must be followed on the labelling of the packages and the vehicles, packaging of the goods - including standards for testing of those packages, driver training, limitations for passing tunnels, etc etc...

In conclusion, I feel that if there is a need to further develop the rules on transport, there is an established system to work through. Developing separate standards for the transport of LMOs would not only create confusion, but would also be subject to all the teething problems that the existing systems have seen. In addition, the law enforcement and civil protection organisations are well aware of ADR, RID and ADN and know how to enforce those rules.

Best regards,

Timo Aaltonen
European Commission
Directorate General for Energy and Transport

Thank you for providing a description of the EU system for transportation of Dangerous Goods that include LMOs.
I am sure that this system is well-developed and works successfully in the European countries.

With regard to the Cartagena Protocol, I would agree that LMOs can represent a kind of danger especially during transportation. However, given that there are no scientifically proved facts of the LMOs dangerous or negative impacts, and the adverse risk is mostly referred to, I would not attribute the LMOs neither to the Class 9 "Dangerous Substances", nor to the Class 6 "Infectious Substance". Instead, we would propose to attribute to LMOs a special status and specific labelling during the packaging /transportation.

Meantime, as for the developing countries and countries in transition it is rather difficult to elaborate their own national standards that would be in line with the international ones, I would support the idea of participating experts, that it is necessary to elaborate the legally binding standards under the Cartagena Protocol.

The experience of the existing standards such as Codex Alimentarius, IPPC and OIE, etc. is highly appreciated and could be widely expanded for all the LMOs types. Thus, it would be worth to have a comprehensive standard document that would be legally binding for the parties of the Protocol.

It seems that the synergism and cooperation of International Standard-setting Bodies and CP Secretariate is crucial for activities coordination in elaboration of databases, information exchange systems such as BCH, standards elaboration, ensuring the  segregation and traceability of LMOs subjected to transboundary movement. The setting up of special permanent working group responsible for cooperative relationships could become an instrument for this scope achieving.

Thank you.

Angela Lozan

Angela,

It is important to note that the EU system referred to in Timo's message is fully based on the UN Model Regulations on the Transport of Dangerous Goods, which are not developed by EU countries only, but by a specific Sub-Committee of the United Nations Economic and Social Council, where all parts of the world, including developing countries and countries in transition, are represented. These Model Regulations have no mandatory status, so they have to a certain extent the same status as standards, but they get mandatoty status when they are transposed into national regulations, or regional or international legal instruments, which is the case in the EU and many othe countries of the world, but also for international transport by air and sea. This is explained in the background document posted on the site, see para 78 to 84.
With respect to the assignment to transport classes, I am afraid that your suggestion that those which are infectious should not be assigned to the class of infectious substances would not receive much support. Even though there is not always consensus on the negative impacts of LMOs as LMOs, when there is evidence that a microorganism, genetically modified or not, meets the criteria for infectious substance, it must be carried in accordance with the requirements applicable to infectious substances, which for easily understandable reasons, are very stringent.
For assignment to class 9, there are no criteria in the Model Regulations for deciding whether they are dangerous or not. They are assigned to class 9 in international transport only if they are not authorized for use by one of the countries of origin, transit or destination, since one of these countries has decided, for whatever reason, that a particular LMO is dangerous and should not be released accidendally during transport. When they are authorized for use in all countries concerned by the international transport operation, they are not subject to transport regulations, unless of course they possess other dangerous properties (toxic or infectious)
Best regards

Olivier Kervella

As suggested by many colleagues special standard for LMO packaging, transportation and handling under 18.3 are needed , Parties and the secretariat of the Protocol should provide guidance and requirements of the UN Model Regulatioins to ensure international harmonization