Theme 1: Existing standards and standard-setting bodies

Dear Participants,

Welcome to the discussion group on “Existing standards and standard-setting bodies”. You are invited to submit your responses to the guiding questions above, to post additional questions you may have and to respond to the comments of others.

The background document prepared for the Forum by the Secretariat includes information on relevant standards and ongoing work of the Codex Alimentarius Commission, the International Plant Protection Convention, the World Organisation for Animal Health, the “United Nations Recommendations on the Transport of Dangerous Goods, Model Regulations”, the Organisation for Economic Co-operation and Development, the World Customs Organization, the United Nations Centre for Trade Facilitation and Electronic Business, the United Nations Commission on International Trade Law as well as standard form contracts for the shipment of grain.

It would be very interesting to hear from participants about the use and implementation of these standards by different countries and stakeholders. Also, participants are encouraged to provide information on efforts and experiences in maintaining and applying rules or standards related to the handling, transport, packaging and identification of living modified organisms that are subject to transboundary movements.

As a participant in this Online Forum on Standards for LMO Shipments, your contribution is very important in making the Forum a success by generating substantive information that can help Parties take an appropriate decision on the matter at their next meeting in October 2010.

The CBD Secretariat thanks you for your active participation. Happy discussions!

Best regards,
The Biosafety Team

Hi Kathryn, 
first of all I'd like to thank you for the summary of information on standards and bodies relevant to the topic of the on-line conference prepared by the Secretariate of the Cartagena Protocol.
I find this document very useful to start discussions on the LMO identification and shipment requirements.
Moldova is currently on the way of implementation of the National Biosafety Framework and the enforcement regulation on labelling, packaging and transportation of LMO is under the preparation now.
Given the different standards of handling, transport, packaging and identification available from the different international bodies, like CAC, IPPC, WOAH, OECD, etc., sometimes it is a perplexity to trace and summarize all the international requirements in a national document.   
Meanwhile, it would be worth to develop an unified stanard  document for LMO identification, handling, transportation, packaging in accordace with Art.18, that will take in account all the LMOs types and uses covered by the Protocol.

Angela Lozan

I totally agree with Angela, in addition to develop an unified standard document for LMO (identification, handling, transportation, packaging) it would be very useful to the parties if each country attempts to deploy there efforts in this area on the Biosafety Clearing House (BCH) website.

I totally agree with Angela, in addition to develop an unified standard document for LMO (identification, handling, transportation, packaging) it would be very useful to the parties if each country attempts to deploy there efforts in this area on the Biosafety Clearing House (BCH) website.

Hi,
I agree with Angela about a special standard for LMO packaging, transportation and handling under Article 18.3. It can be even a guidance on "how to use the existing international regulations and standards". Such a guideline should be prepared by Protocol stakeholders and experts on Biosafety Protocol.

Dear Kathryn
I am Fahimdokht Mokhtari, from Institute of Standards and Industrial Researches of Iran (ISIRI). I have been involving in developing standards for Biotechnology and Biosafety for several years and have had investigated international standards on this matter.
Thank you for the so helpful and comprehensive document on existing standards and standard setting bodies for LMO shipment. After reviewing the document I found out that ISO (International Organization for Standardization (CEN)) as well as other regional (such as European Organization for Standardization) or national organizations stand for developing biotechnology standards, that may be used for Cartagena Protocol requirements, have been ignored.
Though the mentioned organizations are not among the UN organizations, but they have established useful standards which can be applied for transportation and release of GMOs and LMOs.
ISO is the greatest organization for standardization and several standard test methods for identification and detection of GMOs have been developed by this organization. These test methods provide a uniform way for countries in order to detect or identify GMOs which are the subject of Cartagena Protocol.
A Working Group under Technical Committee of Food and feed (WG7/TC34) has worked on standards on identification of GMOs and published 5 standards for detection and identification of GMOs by DNA and Protein based methods, as well as Nucleic acid purification and General requirements (ISO 21569, 21570, 21571, 21572, 24276). Now this WG delivered its tasks on GMO standardization to a Subcommittee on Biomarkers of seeds (SC16).
CEN has also developed many valuable standards for monitoring the GMOs after release and assessing their effects on the environment.
Your reply would be appreciated if I have been confused about the standards and standard bodies.

Dear Fahimdokht,

Thanks so much for your message and your contributions to the Forum. We made a conscious decision not to include information on standards on sampling and detection in the background document. You are perfectly correct in pointing out that there are a number of standards in this area that have been developed by the ISO and the CEN as well as other groups such as the International Seed Testing Association (ISTA). The Codex Committee on Methods of Analysis and Sampling is also undertaking work in this area.

The standards developed by ISO, CEN and ISTA are not, however, publicly available – access to them must be purchased. Unfortunately, the costs are beyond the means of the CBD Secretariat. Any details about the content of these standards are thus greatly appreciated.

I’d also take this opportunity to remind participants of paragraph 2 of decision BS-IV/9 from the fourth meeting of the Parties to the Protocol. The paragraph requests Parties and encourages other Governments and relevant international organizations to ensure that information related to rules and standards on the sampling of living modified organisms and detection techniques, including experience with such techniques is made available via the Biosafety Clearing-House.

Dear Kathryn
I'd like to thank you for your useful reply about the ISO, CEN and standards. I hope it would be possible that such these standards be placed on BCH. However, I think there are so many valuable international, regional and even national standards on sampling and testing that can be used by parties in order to implement the Protocol requirements. Just informing us about these standards would be appreciated. I am sure that parties can pay for purchasing them.
We are setting up national standards on biotechnology and biosafety in our country (Iran) according to the international ones. Such an information will be helpful for us.

Dear Kathryn,

My question/idea is about your reply stating that "The standards developed by ISO, CEN and ISTA are not, however, publicly available – access to them must be purchased. Unfortunately, the costs are beyond the means of the CBD Secretariat. Any details about the content of these standards are thus greatly appreciated."

I understand that each Party/non-Party to the Cartagena Protocol will probably have access to the ISO standards (as ISO memebers), to CEN standards (as European members), and perhaps also to ISTA (if they are members).

My question or idea:
If the Secretariat (SCBD) develops a Memorandum of Understanding (MoU) and persuades secretariats of each of the three organizations (ISO, CEN and ISTA) to sign this MoU that can include, if necessary, observer status for the SCBD at meetings of these organizations, then you could have not only access to their standards but also, perhaps, be involved in standards implementation, etc., would you (the Secretariat) not?

Other benefits of such a MoU would be integration of Protocol provisions into implementation/amendment of the standards of these organizations, avoiding duplication.

The costs would be, of course, the expenses incurred for SCBD official(s) to participate in these meetings. The costs can be minimized by restricting SCBD participation only to few crucial meetings while still having SCBD access to all relevant standards and documents of each organization.

To do so, however, you (the Secretariat) will need a COP/MOP Decision that one or more Parties to the Protocol can propose such a MoU, is this correct?

Alternatively, this suggestion/idea presented here might be sufficient for the Secretariat to initiate such a MoU or will it require backing from a Party or others registered for this online forum?

If necessary, I am willing to voluntarily assist you and others in drafting such a MoU.

Thank you in advance for your reply.

From: gunasutra@yahoo.in

Dear all,

Referring to the various comments concerning ISO or CEN standards, I would
like to share our UN secretariat experience in relation to the use of ISO
or EN standards in transport of dangerous goods regulations.

For ISO standards, we have not experienced any problem.  ISO is in
consultative status with the UN Economic and Social Councill and cooperates
accordingly with ECOSOC subsidiary bodies, but also, I assume, with other
UN entities.The UN Sub-Committee of experts on the Transport of Dangerous
Goods has liaison status with a number of ISO Technical Committees, and
therefore we get the relevant information relating to the work of these
committees. The same applies to quite a number of UN intergovernmental
bodies. The ISO secretariat provides us, free of charge with all relevant
standards. ISO standards may be referred to in the UN Model Regulations on
the Transport of Dangerous Goods only when the Sub-Committee has checked
that they meet the required safety level.
Normally administrations can get copies of ISO standards from their
national standardization bodies.

The fact that ISO standards are not publicly available free of charge may
however be a problem for those who have to apply the regulations, when the
regulations require the application of a given standard. The same applies
to EN standards.

For EN standards, we cannot get copies of final standards free of charge.
National administrations - in EU countries-should be able to obtain them
from their national standardization body, but it seems that in practice it
is not always that easy. Since once adopted the EN standards have to be
applied by all EU countries, we have had to establish a process of
cooperation with CEN to avoid contradictions between some EN standards and
legal instruments that apply to transport of dangerous goods in Europe
(RID, ADR, ADN). In short, all standards prepared by CEN and which may have
some kind of relation with transport of dangerous goods requirements (e.g.
packaging standards) are submitted to the Joint Meeting of the UNECE
Working Party on the Transport of Dangerous Goods and of the RID Safety
Committee for checking compliance with the essential safety requirements of
RID/ADR/ADN before final adoption by CEN. If there are contradictions, CEN
revises the draft standard to ensure compliance. If at the end the final
standard still does not meet the safety requirements, it cannot be referred
to for application under RID/ADR/ADN. Copies of the draft standards are
made available to the UN secretariat and members of the Joint Meeting at
these various stages of compliance checking

Best regards
Olivier Kervella

Dear Guna Sutra,

Decision BS-II/6 from COP-MOP 2 requests our Executive Secretary to cooperate with a number other organizations, conventions and initiatives. Paragraph (f) specifies establishing cooperation with the International Organization for Standardization (ISO), amongst others. This decision has been reinforced by subsequent decisions on cooperation taken at MOP-3 and MOP-4 (decisions BS-III/6 and BS-IV/6, respectively.) We thus do have a mandate to enter into MOUs with other organizations, including ISO.

As for participation in the meetings of other organizations, it would be up to the Parties to agree to provide sufficient funds in the Protocol's budget to cover the associated costs.

Best wishes,
Kathryn

Dear Kathryn,

Yes, soon after I posted that message, I too realized this (that the Secretariat does not have the mandate to enter into MOUs with ISO, CEN, ISTA and other organizations) because I then checked the Decisions you state.

But I hastily wrote the message in reply to your statement of not having access to make you aware of ways of getting access and, as is clear from Olivier Kervella's reply to mine, to make national authorities realize ways of not only getting access to but also being proactive in influencing standards-setting by collaborating with their national standards bureaux.

And you (the BCH team/the Secretariat) have not provided a "remove" button to delete or remove a message already posted. Therefore, I could not remove or delete that message after reading the Decisions and Olivier Kervella's reply.

Of course, the "edit" button is truly useful.

Anyway, I hope that whatever I wrote will be useful to ponder upon by both participants of this Forum and by all of you organizers too.

And I hope that Party representatives realize that if they propose some idea/suggestion, then they need to back it up with proposing a draft decision at COP/MOP without which the Secretaiat cannot have the mandate to implement what they proposed.

I thank all of you for your efforts in this respect and, most of all, for keeping this Forum open to any person without having to state a job title and employer - only possibility for me to register and actively participate in these last two days.

Good luck to you and others in the follow-up work, once the Forum closes today.

From: gunasutra@yahoo.in