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Information availability and acessability [#696]
My name is Darja Stanič Racman and I'm with the Ministry of Environment and Spatial Planning from Slovenia. I'm the head of Biotechnology department, which is responsible for biosafety in relation to the environment. I'm also Cartagena Protocol focal point for Slovenia.
Our experiance showes that a lot of information exists and is readily available and acessible on the internet aspecily for the most common GM crops.
It seems that we have the bigest problem of finding the information that is relavant for our specific receiving environment eg. information on non-target organisms, wild relatives etc.
The next issue that has arised in terms of information acessability  is related to post market monitoring. There are a lot of date availble on the environment, agriculture, geology, climate etc. on national level that could be useful for the case specific or general monitoring, but because current databases were not designed to support GMO monitoring, it is difficult to effectively use them. It also means some technical adaptation of current databases and quite substantial costs. We are now at the begining of the process of reviewing existing databases to also identify if some relevant informaition sets are not covered jet in our different national monitoring shemas.
posted on 2008-11-03 10:14 UTC by Darja Stanic, Slovenia
 
RE: Information availability and acessability [#697]
My name is Lenia Arce, and I am the head of the Safeguard Department of the National Centre for Biosafety, Cuba. This centre is the National Authority for the Cartagena Protocol and the focal point for the BCH in Cuba. Unfortunatly we have serious problems witht the availability of the information regarding monitoring of LMOs. despite of having difficulties with internet connection, is also very difficult for us to find specific information, technical information, regarding monitoring of LMOs, i.e sample scale, the lengh of the process and the specific elements to be monitored.
posted on 2008-11-03 14:18 UTC by Lic. Juan Carlos Menéndez de San Pedro, Centro Nacional de Seguridad Biológica
 
RE: Information availability and acessability [#699]
My name is Aleksej Tarasjev, and I am scientist from Serbia working in the field of evolutionary ecology and ecological genetics of plants. I am currently serving on Serbian National Biosafety Committee. I am also working as regional advisor for Cartagena Protocol on UNEP GEF BCH Project and as FAO Consultant on Agricultural Research and Biotechnology for Europe and Central Asia. Of course, I participate in this conference in my personal capacity.

I presented overall current status of capacity-building in the area of environmental risk assessment in West Balkan countries on SCBD meeting in Chisinau, Moldova. That information is available on this site Suggested readings section (UNEP/CBD/BS/COP-MOP/4/INF/15 and links to the presentations therein) so details regarding situation in our region can be found there.

I agree with Darja and Juan Carlos regarding information needs that were mentioned in their postings. But there is also urgent need for expertise, institutional capacities and synergy between different institutions. Countries in the region do not have enough experience in post release monitoring of GMO but already receive applications for environmental releases (field trials), sometimes even with new modification events and new constructs. These capacities are also important for monitoring for possible illegal or unintentional release of unapproved events. And there are cases of unapproved release that already happened in the region.

  I will add more in part of our discussion that will focus on the major needs and gaps as well possible ways and means of enhancing capacity-building efforts in that area.
posted on 2008-11-04 09:50 UTC by Dr Aleksej Tarasjev, Institute for Biological Research, University of Belgrade, Serbia
 
RE: Information availability and acessability [#700]
My name is Angela Lozan, and I am working with the Ministry of Environment and Natural Resources of Moldova, as the head of Biosafety Office and the NPC for UNEP/GEF Biosafety Implementation project. 

I would like to mention that the CBD/CP bch website is a very helpful source of available information and world experience in providing RA/RM for various species of LMOs to develop the countries capacities and procedures. I also would refer to the SCBD workshop for CEE on capacity-building for risk assessment/management in Chisinau, Moldova, 2007 where countries discussed the current status and needs of RA/RM and generated values proposals to be undertaken for the next. 

Moldova, between the other countries in transition in the region now has poor experience and capacities in conducting the risk assessment/management procedures. I can refer to the insufficient regulatory and procedural framework, not enough institutional capacities, research and training capacities, lack of guidelines materials and manuals in national language etc. There is also no any experience to providing the post release monitoring of LMOs and in special to take into consideration possible effects to non-target organisms, wild relatives during the field trails and release into environment.

Because of a poor inter-sectorial collaboration and insufficient level of exchange of information between research institutions in the country there is some constrains to meet synergism and cooperation in providing RA/RM. The national environment monitoring system also not includes the GMOs monitoring and post-release monitoring data.

I agree with proposals of Darja and Alexejand in my view it would be helpful to ensure collaboration between countries in developing of technical guidelines and manuals for RA/RM, with attention to those species that could have any prospective commercial interest to the area. It is considered preferable to harmonize methods and techniques for post-release monitoring based on the reviewed and updated databases. The exchange of information and access to the national databases of the region should be further improved and upgraded, as well as special trainings and workshops in order to share experiences and good practices.
posted on 2008-11-04 11:46 UTC by Dr. Angela Lozan, Republic of Moldova
 
information on existing RA/RM capacity building initiatives [#701]
My name is Hartmut Meyer, I work as a biosafety consultant for the German Federal Ministry for Economic Cooperation and Development and GTZ, the German Agency for Technical Cooperation. I also chair the Steering Committee of the Coordination Mechanism for capacity building of the Protocol. The result of this online conference should be to enable a better preparation of our next Coordination Meeting in March 2009 and to make the meeting as effective as possible.
I would like to encourage the participants to send us more information on RA/RM capacity building initiative which have been organised by you or in which you take part. It would be of great value for us to receive information about relevant internet pages, guidelines or manuals and reports, publications or evaluations.
With many regards, Hartmut
posted on 2008-11-04 14:09 UTC by Dr. Hartmut Meyer, Deutsche Gesellschaft fuer Internationale Zusammenarbeit (GIZ)
 
RE: information on existing RA/RM capacity building initiatives [#703]
My name is Lenia Arce, I work for the National Center for Biosafety in Cuba. This is my second message and I would like to share information about our initiative on this matter. As the Dr. Meyer said it would be very useful to get information about the initiatives developed by countries with regard to RA/RM. In the case of Cuba we have developed a small guide for RA/RM of LMOs, addressed to the applicants for Biosafety authorizations and  the assessors of the regulatory center also. This guide includes all applications which involve LMOs for contained use or intended release into the environment. The objective of this guide is to harmonize the RA/RM process by using some techniques for the identification of risks, among other aspects. This guide will be post in the BCH as soon as this conference ends. Unfortunatly the guide is in spanich language only.
posted on 2008-11-05 15:10 UTC by Lic. Lenia Arce Hernandez, Centro Nacional de Seguridad Biológica
 
RE: Information availability and acessability [#707]
My name is Antonietta Gutierrez Rosati, principal professor at the National Agrarian University- La Molina - UNALM, Director of the Genetic Resources, Biotechnology and Biosafety Research Center - CIRGEBB and Technical Director of the NGO Desarrollo Medio Ambiental Sustentable - ASDMAS. The CIRGEBB and ASDMAS, together, at national level are currently working on the detection and monitoring of LMOs in Peru, giving, to the NCA in 2007, his report about maize monitoring. Also UNALM / ASDMAS during the last seven years have dedicated efforts to provide training to different stakeholders on risk analysis and assessment, through the organization of workshops, lectures, seminars, forums, etc., contributing with technical support, legal information and support for decision making processes. In addition to this effort, recently, various civil society organizations have been developing workshops. The governmental sector has organized a few capacity building activities. For more details please visit the web site: http://www.asdmas.com/bioseguridad.

Peru needs to improve the inter-agency and multi stakeholder collaboration to promote development of national capacities. While globally there is a lot of “free information” on the Internet, there is not much “official information” available. It is not easy to access official documents from the competent authorities; because they are not placed on their Web sites or at The BCH. Therefore there is little official information that might be useful for decision making processes.

In South America, institutional capacities, human resources training, research development and environmental monitoring; is directly related with the degree of adoption of LMO`s, with the greater or lesser investment in science and technology and with the development of domestic and export markets for LMOs.

………………………

Mi nombre es Antonietta Gutierrez Rosati, profesora principal de la Universidad Agraria La Molina – UNALM, Directora del Centro de Investigación en Recursos Genéticos, Biotecnología y Bioseguridad – CIRGEBB y Directora Técnica de la ONG Desarrollo Medio Ambiental Sustentable – ASDMAS. El CIRGEBB  y ASDMAS, juntas, en el ámbito nacional están trabajando en la  de detección y monitoreo de transgenicos en Perú, habiendo brindado; en el año 2007; a las AC, su reporte sobre el monitoreo de maíz.

Asimismo UNALM/ASDMAS desde hace mas de siete años ha dedicado esfuerzos por brindar capacitación a los diferentes actores en análisis y gestión de riesgos a través de la organización de cursos, conferencias, seminarios, foros parlamentarios, etc, brindando información técnica, explicación legal y apoyando en la toma de decisiones. A este esfuerzo se suman los que últimamente viene desarrollando varias organizaciones de la sociedad civil y algunos pocos cursos que el sector gubernamental ha efectuado.  Para mayor detalle por favor ingresar en la Web http://www.asdmas.com/bioseguridad.

En Perú se necesita mejorar el trabajo interinstitucional y la colaboración de los diferentes actores a favor del desarrollo de capacidades nacionales.

Si bien a nivel global existe mucha información libre en Internet sobre los principales LMOs de uso comercial, no es mucha la información oficial disponible. No es fácil acceder a documentos oficiales de las Autoridades Competentes en sus sitios Web o a nivel del BCH. Por lo tanto es escasa la información oficial que pueda se útil en la toma de decisiones.
posted on 2008-11-05 17:56 UTC by Dra. Antonietta Gutiérrez Rosati
 
Costa Rica [#709]
My name is Alejandro Hernandez, I work at Biotechnology Program, Phytosanitary Service,Ministry of Agriculture and Livestock Costa Rica. I work in risk assessment and management, and I also teach bioinformatics in the University.

Costa Rica have Laws and regulations available at the BCH. The national process and guidelines are available at our national web page http://cr.biosafetyclearinghouse.net/ , in "Leyes, Regulaciones y Guías Nacionales" (http://cr.biosafetyclearinghouse.net/laws/laws-search.shtml?searchid=344475)

There is no "deregulated" status in Costa Rica. All fields, seeds, production are regulated, and constantly monitored. 

Costa Rican Ministry of Environment, Ministry of Health and Agriculture are working hard in order to harmonize and implement the Cartagena Protocol in the near future.
posted on 2008-11-06 03:57 UTC by MSc. Alejandro Hernández Soto, Costa Rica
 
Sharing experiences in capacity building and education on biosafety [#710]
Dear all, My name is Kazuo Watanabe, a professor residing Gene Research Center, University of Tsukuba, Japan.  I have been with the Protocol as the part of japanese delegation since the beginning of negotiations. I also have been involved in consultation and capacity building for many developing countries through bilateral arrangements or by multilateral aid channels.  We have formed up an informal collaboration tie after the Decision BS-III/3 (http://www.cbd.int/biosafety/cop-mop/result.aspx?id=11059) Also the meeting is one of informal follow up after SECOND INTERNATIONAL MEETING OF ACADEMIC INSTITUTIONS AND ORGANIZATIONS INVOLVED INBIOSAFETY EDUCATION AND TRAINING (UNEP/CBD/BS/CM-ET/2/4 18 June 2007). Please visit the site for short description, while we are yet within Asia, the Asian experience can be shared with other regions. The needs vary country to country, but the experiences can be shared more effectively especially via South to South collaboration rather than North-South which sometimes there are too much gaps on systems and availability of specific resources for implementation.

ABEN http://www.aben.ait.ac.th

Prof. Dr. Kazuo Watanabe
posted on 2008-11-06 07:51 UTC by Dr. Kazuo Watanabe, University of Tsukuba
 
RE: Sharing experiences in capacity building and education on biosafety [#712]
My name is Gabor Lovei; I am a Danish nominated expert and have been engaged in GM biosafety capacity building in Asia, Africa and S America. Currenlty, I am leading BiosafeTrain, a DANIDA-funded project in biosafety capacity building in East Africa (see http://www.biosafetrain.org).
In my experience, capacity building so far was mostly "on paper" - not useless and necessary, but until Cartagena Protocol signatories, esp. developing countries do not have experimental protocols, facilities and personnel, real RA/RM remains a dream. There is great need to share experimental protocols and evaluation methods. In this, the three handbooks published by CABI under the series "Environmental Risk Assessment of Genetically Modified Organisms", emerging from a multi-year international collaboration, constitute a useful example. Regional collaborations would also greatly assist.
posted on 2008-11-06 09:40 UTC by Dr. Gabor Lövei, Danish Institute of Agricultural Sciences
 
Sharing experiences in capacity building and education on biosafety [#713]
My name is Eliana Fontes and I have been working as an expert with the Brazilian Delegation since the beginning of negotiations of the Cartagena Protocol. I also helped the implementation of Brazilian biosafety regulations as first Executive Secretary of the National Biosafety Commission. Throughout these years I had the opportunity to participate and organize quite a few national and regional capacity building initiatives. Among these, my mostly successful experience was with the GMO ERA Project (http://www.gmoera.umn.edu), particularly the development of a train the trainers program through forming expert teaching teams and developing teaching tools that are available to the formed teachers. With this program in Brazil we were able to engaged scientists and university professors in the scientific discussions on ARA around the country, instigate others to also participate, and some of them are even now teaching and/or doing research on ARA, including a formal course (discipline) at the University of Viçosa. Descriptions and reports of the activities of the Brazilian Teaching Team of the GMO ERA Project is available at: http://www.gmoera.umn.edu/public/regions/brazil.html
But such initiative was only successful because of the substantial funding provided by the Suiss Agency for Developement and Cooperation, the strong lidership of the international coordinators of the GMO ERA Project, and also (very important!) the engagement of local scientists and university professors who enthusiastically coordinated the activities in Brazil and took additional initiatives to complement the project.

I agree that there is great need to share experimental protocols and evaluation methods, and that the three handbooks published by CABI under the series "Environmental Risk Assessment of Genetically Modified Organisms" constitute a useful example.
posted on 2008-11-06 20:34 UTC by Dr. Eliana Maria Gouveia Fontes, Brazil
 
Sharing information of RA, RM and post release monitoring [#715]
My name is Will Tucker.  I work in the Australian Office of the Gene Technology Regulator (OGTR).  This office has been conducting risk assessment and developing risk management plans in relation to GMOs (contained dealings as well as environmental releases) and post release monitoring since 2001 under the national legislation - the Gene Technology Act 2000.  This office has developed the Risk Analysis Framework which documents the methodologies of risk assessment and risk management for GMOs which we apply.  We have also developed other supporting documents, such as documents on the biology of plants species for which we have received GM environmental release application and information of monitoring protocols and activities.  These documents are available on our web site (http://www.ogtr.gov.au), along with the risk assessment and risk management plans prepared in response to every environmental release application that had been evaluated.

Dr Aleksej Tarasjev [#699] indicates that there is “not have enough experience in post release monitoring of GMO but already receive applications for environmental releases (field trials)”.  In relation to field trials, if risk assessments have been done and appropriate risk management measures determined and imposed on the field trials, then the purpose of post release monitoring is to determine if these conditions are being properly applied, and if these measures are successful in limiting the spread and or persistence of the GMO (which are likely aims of the risk management measures for field trials).  Requirements for such monitoring of GM plant field trials are some familiarity with plant species and the relevant agricultural practises, and knowledge of the risk management measure imposed and their desired effect.  GM plants behave like other plants and do not generally require more specialist knowledge/data.

This office also participates in capacity building activities.  For example in some of the Training Workshops on Safety and Risk Assessment of Agriculture-Related GMOs organised by International Life Sciences Institute (ILSI) Southeast Asia Region (see http://www.ilsi.org/AboutILSI/IFBIC/IFBICcoreactivities.htm - some documentation is available):
• In collaboration Association of Southeast Asian Nations (ASEAN), Agri-food Veterinary Authority (AVA), Health Canada, and Australia-New Zealand Food Authority (ANZFA) in July 2001, in Singapore.   Forty regulatory officials participated in the workshop. Proceedings from the workshop were published in December 2001.
• A follow-up workshop took place in August 2002, in Kuala Lumpur, Malaysia, with training provided again by Health Canada and the Food Standards Australia New Zealand (FSANZ) along with support from the local government and regulatory bodies.  Proceedings from the workshop were published in December 2002 (http://www.aseansec.org/pdf/2nd_gmo.pdf).
• The third workshop took place in August 2003 in Bangkok, Thailand, in collaboration with Health Canada and FSANZ, with the participation of the OGTR.
• The fourth workshop took place in August 2004 in Jakarta, Indonesia, with the additional participation of the OGTR and the U.S. Food and Drug Administration (U.S. FDA).
posted on 2008-11-07 01:33 UTC by Mr William Tucker, Department of Health and Ageing
 
Answers-KH [#716]
1. My name is Pisey Oum, Technical Advisor for MOE and National Focal Point for CPB of Cambodia. I am in charge of the impelementation project of the biosafety framework. We are currently developed our own national risk assessment and risk management guideline for assessing the risk from LMOs when there are import application.

2. In terms of institional capacity, we have our national law on biosafety passwed by the Parliament and Senate in January 2008 and promulgated by the King in February 2008. We are currently renovating LMO detection lab. We still need capacity at individual level for risk assement and lab person to work in this field.

3. Most data on LMOs will be ready for BCH because we have established a BCH task force to work on this. However, insofar, we have not seen any official release on LMOs yet in the country.

4.We have mainstreamed emergency response measure on monitoring and in the case of outbreak of risk from LMOs application into the legal framework, which requires releveant ministries to participate.

5. Previous capacity building can help the country like Cambodia in terms of individual and institutional level. Cooperation and sustainable funding is important.

6. We have law to implement the CPB and risk assessment of LMOs in the country, cooperation and enabling environment is essential for monitoring the post-release of LMOs. Public understanding for decisin-makers, politicians are important to increase the level of cooperation and the flow of imformation.

7. We have not had any release of LMOs, so we cannot answer this question. Bu the role of relevant agencies in post -release of LMOs is important including media.
posted on 2008-11-07 14:42 UTC by Dr. Pisey Oum, Cambodia
 
Sharing experiences on capacity building [#773]
Greetings. My name is Bosibori Bett.  I have been involved/participated in the capacity building of biosafety issues to regulators and scientists.  An outstanding observation made is an interactive discussion and sharing of the past experience related to GM crops.  My reference is made to a recent training workshop in Burkina Faso, a country whose Biosafety/GM Legislation is in place. The enormous contributions that emerged from the workshop involving regulators and scientists, on their past experiences, in my opinion, are an encouragement to Kenya.  Methodologies for carrying out field experimentations of GM crops, experimental designs, data collection, and the research findings, etc. were shared.  I am certain that such findings are vital in making references within the region and elsewhere.  Additionally, it is in this forum that we learnt from a Member of Parliament in the discussion, that another African country, Mali, had passed their bill into a law.  I feel that Kenya could see these countries as a model, but of course there is need to begin from somewhere.  Finally, the Minister of Agriculture launched a national strategy for biotechnology awareness (BioAWARE) to create awareness on biotechnology.  This is one way of filling any gaps on awareness creation and capacity building besides showing government support on the same. 
Thanks.
posted on 2008-11-19 18:17 UTC by Mrs. Bosibori Bett, Kenya Agricultural Research Institute (KARI)
 
RE: Sharing information of RA, RM and post release monitoring [#815]
As William Tucker says the risk assessment/risk management process should have identified the steps to take to manage the field trials, then the post-trial monitoring should verify that those steps are followed and are effective. Experience in this area exists in many countries from practitioners (academia and industry) that carry out field trials and government inspectors. This experience should be tapped.

Training done for operators of field trials could be interesting also for inspectors.
posted on 2008-11-28 12:43 UTC by Esmeralda Prat, Bayer CropScience
 
RE: Sharing information of RA, RM and post release monitoring [#826]
In cases of applications with new constructs and not enough data/ experience in risk assessment problems were solved by very strict risk management eg by avoiding exposure in cases that we don’t know much about hazards. It can include such measures and techniques as male sterility, markers that enable detection of volunteers, pre reproduction-harvesting etc. however, this can be only ad hoc approach. We definitely need capacity building in risk assessment and monitoring because this risk management-based approach to decision making cannot be applied to large scale environmental releases. Also we lose valuable without monitoring of risk management-based field trials we fail to gather valuable information that can be used in applications for larger scale releases.
posted on 2008-11-28 20:45 UTC by Dr Aleksej Tarasjev, Institute for Biological Research, University of Belgrade, Serbia
 

   
   
Update on 2008-11-28
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