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Session 2: Capacity-building needs, gaps and priorities [#714]
Session 2 (Days 3 & 4): Capacity-building needs, gaps and priorities 

Urgent needs in terms of Capacity Building (risk assessment and post release monitoring of LMOs`s)  in my opinion are:

1 .- Establishment of national biosafety research programs to be led by the governmental sector, but with respect and inclusion of other stakeholders.
2 .- Adoption and implementation of a plan of action for capacity building that must be a multi-institutional effort.
3 .- Increase Human resources capabilities by increasing the knowledge level of professionals. In the short term is required technical development and in the medium and long term achieve optimum research levels.
4 .- Strengthen partnerships between academia and governamental institutions to achieve in a short time adequate level of capacity building.
5 .- Urge a real national commitments with respect to RA and post release monitoring of LMO´s. That means increase the presence of NCA throughout the country with good logistics and infrastructure.


Las necesidades priorizadas y urgentes en cuanto al Desarrollo de Capacidades (relacionadas al evaluación de riesgo y monitoreo post liberación de OVM`s)  en mi opinión se centran en:
1.- Establecimiento de programas nacionales de investigación en bioseguridad que siendo liderado por el sector gubernamental incorpore a los otros actores interesados en el.
2.- Adopción e implementación de un Plan de Acción para el desarrollo de capacidades que debe ser concebido como un esfuerzo multi-institucional.
3.- Incrementar las capacidades de los recursos humanos, incrementando el nivel de los conocimientos que le permitan cumplir adecuadamente la evaluación y monitoreo de OVM`s. en el corto plazo se requiere desarrollar cuadros técnicos y en mediano y largo plazo alcanzar niveles óptimos en la investigación.
4.- Fortalecer alianzas entre el sector académico y las instituciones oficiales a fin de lograr acortar posplazos para el desarrollo de capacidades.
5.-  Urge generar reales compromisos nacionales por el AR y monitoreo de OVM´s y ello significa mayor presencia de las AC en todo el territorio nacional con logística e infraestructura que su desempeño significa.

Antonietta Gutièrrez Rosati -
(edited on 2008-11-06 23:43 UTC by Antonietta Gutiérrez Rosati)
posted on 2008-11-06 23:42 UTC by Antonietta Gutiérrez Rosati
RE: Session 2: Capacity-building needs, gaps and priorities [#717]
1. We are lakcinf of capacity on certain aspects of environmental risk assessment and post-relase monitoring of LMOs. This includes: surveilance system of risk exposure according to the nature of LMOs; detection capability on regular check, and information flow when a new discovery on risk of LMOs release.

2. Over the next five year, we need training at regional level mainly on harmonizing standard of risk assessment, and information flow on monitoring, LMOs detection and emergency response. At national level, we need capacity building for individual on risk assessment and risk management including emergency response. At local level, risk assessment and post-release of LMOs should be allowed for academia and civil society to participate.

3. Main institutional infrastructure needs: lab facilitiy for detection. A certified regional lab facility is essential. Countries in the region such as ASEAN should have similar legal framework so as to ease in the implementation of the CPB since we have similar ecosystem and proximity that allow a possible transboundary movement of LMOs from one country to another. Court system is important.

4. Information on a particular LMOs of the release including its traits, transformation events, risks to environment and human health.

Pisey Oum
posted on 2008-11-07 14:46 UTC by Pisey Oum
RE: Session 2: Capacity-building needs, gaps and priorities [#719]
As the Dra. Antonietta said, the needs in terms of capacity building for RA and post release monitoring are focused on administrative and technical aspects. A synergy among all national stakeholders involved in RA/RM and monitoring is strongly needed in order to channel the efforts, in a coordinated way, to achieve an adequate level of infrastructure. Among technical aspects, urge the capacity building on detection and identification of LMOs which includes method and procedures for taking samples and the existence of accredited laboratories with the necessary equipment to that aim. This entails that the human resources have to be trained in these techniques. On the other hand, some infrastructure on laboratory tests is needed for undertaking the RA process with an acceptable safety level, for example, eco- toxicological studies among others.
posted on 2008-11-07 14:51 UTC by Lic. Lenia Arce Hernandez, Centro Nacional de Seguridad Biológica
RE: Session 2: Capacity-building needs, gaps and priorities [#750]
Dear participants,

there are only some postings in this session but they contain very useful suggestions which - according to my knowledge - quite well reflect the discussions elsewhere. Thanks for the messages!

I tried to bring your suggestions together, it seems useful to group them as elements and activities of a Plan of Action:

Plan of Action for Biosafety Capacity Building in RA and PRM

Elements of PoA
a) risk research
b) risk assessment
c) LMO detection
d) public participation mechanism

Activities to implement PoA
a) increase human capacities
- short-term training for technical capacities
- long-term training for scientific capacities
b) establish academia-governmental partnership
c) build up logistics and infrastructure
- national LMO detection labs
d) access to existing information on LMOs in the process of RA and/or PRM

Regional Aspects
- regional lab for certification
- regional information network
- harmonization of RA standards

At this moment I prefer to deal with national and regional aspects seperately because the processes and institutions involved in setting up such Plans are certainly different. Although of course national and regional aspects are interlinked and should be supportive to each other.

Please send in additional comments and suggestions so that we can gain a more complete picture or the gaps, needs and priorities.

Many regards,
Hartmut Meyer
posted on 2008-11-13 15:41 UTC by Dr. Hartmut Meyer, Deutsche Gesellschaft fuer Internationale Zusammenarbeit (GIZ) GmbH
RE: Session 2: Capacity-building needs, gaps and priorities [#751]
My name is Dubravka Stepić, the BCH and CPB National Focal Point of the Republic of Croatia. I appreciate very much and would like to thank Dr. Meyer on his last message. It is concise, to the point and well structured. For sure those listed elements and activities are basic to start building on each of our national capacity in the domain of RA and RM. At the same time, his proposal is excellent starting point and might be the guide to look at and build our needs on a global level in a more structured way.

In regards to capacity building needs, gaps and priorities in Republic of Croatia, particularly those related to the risk assessment, risk management and post-release monitoring of LMOs, we in Croatia are really starting from „scratch“.  All listed elements and activities should be part of our priorities but my country does not have means to facilitate their realization. It is obvious that the same is the case with other developing countries and I may also say with other countries in transition particularly those CEE countries that are not yet part of the European Union.

In regards to just only LMO detection and laboratories in Croatia, we still have a lot of work to do. There is still a need to strenghten those facilities in sense of the equipment and training of technical capacities as well as further training of experts. Full accreditation of our two laboratories for GMO analysis and identification is still yet to be accomplished.

Experts in Croatia do not have any experience in carrying on environmental risk assessments or conducting post-release monitoring of  GMOs. Part of legislation (GMO Act) that puts in place scientific and advisory bodies that should deal with those issues, is still not operational and therefore this aspect/issue is not yet implemented in practice. Another issue that is coming is that people who most probably will be part of those bodies and will have to conduct risk assessments, will be the same ones also involved in handling applications/dossiers and approving imports and introduction to the environment of GMOs. Because of the obvious danger of the conflict of interest, in the case of Croatia it is of the utmost importance to include more young people, students in relevant scientific disciplines in those activities particularly through the help of international community, especially through training opportunities (short and longer) in member states of the European Union. In addition to that,  I would like to see more involvement of the UNEP-GEF which proved to be very successful in helping developing countries and countries with economies in transition to build their biosafety and BCH capacities through the UNEP-GEF projects scheme (Development of NBF, BCH projects and Implementation of the NBF). The next cycle of UNEP-GEF projects should involve projects that could help developing countries and countries in transition to develop capacities in RA and RM. 

Another important point to seriously consider is a regional and subregional cooperation and linkages of institutions and experts, exchange of information, scientific materilas and practically gained experiences. As the situation in subregion is more or less the same as in Croatia, we will have to depend on the help from the European Union mainly.

In general, the role of the BCH in regards to the whole issue of RA and RM is tremendous as it is the first place that should be looked at in searching for all available information.
posted on 2008-11-13 19:45 UTC by Dubravka Stepic
RE: Session 2: Capacity-building needs, gaps and priorities [#756]
My name is Doreen Shumba-Mnyulwa and Iam the coordinator of Regional Agricultural and Environmental Initiatives Network-Africa (RAEIN-Africa). RAEIN-Africa network partners recognised that the role of developing countries' scientists, especially those in public research institutions, should be to reduce the level of uncertainties of LMOs through research and improved methods to test for adverse outcomes. recognising this role, most of our network partner countries have indicated that they are unable to manage and monitor the use of modern biotechnologies adequately. The major limitation is limited capacity. Of concern to stakeholders in the Southern African region  are issues pertaining to the nature of relationships between GM crops, soils and agro-biodiversity, the impacts of climatic conditions on ecological safety and the whole range of food safety concerns related to GMOs under the conditions experienced by African consumers, such as diets dominated by one product and the vulnerable health status. 

Generally, I therefore agree with the contributions given in this forum . I, however, would like to share with you those priorities identified by our network particularly those related to the risk assessment, risk management and post-release monitoring of LMOs, these include:
• Core scientific capabilities and infrastructure are required for product testing, evaluation, risk management, inspection and monitoring.
• Competencies in managing the institutional processes that support these activities
• Public awareness creation and public participation processes (best practices and sharing of experiences)

Given the varied levels of capacity and resource endowment in the various countries, structures and mechanisms of collaboration and the development of synergistic relationships should be developed to facilitate the harmonisation of methods, standards and  pooling of resources.
posted on 2008-11-14 13:58 UTC by Mrs Doreen Shumba-Mnyulwa, Regional Agricultural and Environment Initiatives Network-Africa (RAEIN-Africa)
RE: Session 2: Capacity-building needs, gaps and priorities [#803]
The situation in my country, Saint Lucia, is similar to that of Croatia.  We have little capacity in country, in risk assessment and management, as far as GMOs/LMOs are concerned.  The suggestions made here will also apply to my country.  In truth, UNEP-GEF should assist if possible in building capacity in RA and RM for GMOs for developing countries.

Just as for Cuba, the implementation project for the Biosafety framework that we will soon be embarking on may help us in building capacity in RA/RM in country.  It may be useful to learn fom Cuba how they did so. Maybe best practices in that area of capacity building can be published on the BCH.
(edited on 2008-11-25 13:09 UTC by Anita James)
posted on 2008-11-25 13:00 UTC by Ms. Anita James, Saint Lucia
RE: Session 2: Capacity-building needs, gaps and priorities [#757]
Regarding the listed elements of a P o A and the activities to implement them, in the case of Cuba, all of them are addressed with a just a little financial resources coming from the national budget. We were benefit from 2 UNEP/GEF projects aimed at the Creation/Implementation of a National Biosafety framework. Those projects allowed the completion of the budget for undertaking some task related to RA/RM among others aspects concerning the administrative structure for Biosafety and the control mechanisms for LMOs, carried out by such administrative structure.

We are now elaborating a third GEF project aimed at the completion of the technical, legal, infrastructural and managerial gaps in biosafety found in National Competent Authority to attain the successful and sustainable implementation of the Cartagena Protocol in Cuba.   Although there is a strong will in Cuba aimed at the creation of an appropriated infrastructure to this aim, and several agencies are working in the design of a laboratory for the detection and identification of LMOs using our national resources, We envisage that this project will contribute to that aim.
posted on 2008-11-14 14:44 UTC by Lic. Lenia Arce Hernandez, Centro Nacional de Seguridad Biológica
RE: Session 2: Capacity-building needs, gaps and priorities - how to focus? [#770]
Hello all, this is John Komen of PBS, again. Excellent discussion so far! Looking from the perspective of a program providing support to biosafety capacity development, we're faced with the challenge that many countries have a very comprehensive list of needs and priorities, for good reasons of course. But, where to start?

In our work in a number of countries in Africa, we've focused initially on capacity development regarding the safe conduct of confined field trials. This has several advantages as (i) the emphasis is on risk management (confinement) not full environmental risk assessment; (ii) it's a way to gradually build up skills and familiarity with LMOs, including the generation of data that will be relevant when considering a general release; (iii) often, they can be regulated under existing legislation, before a comprehensive biosafety law is in place.

For capacity building support, this meant that priorities included the development of guidelines and application forms; detailed Standard Operating Procedures for the safe conduct of trials; and, hands-on training of scientists (applicants), regulators, trial managers and inspectors.

At a later stage, the focus shifted to environmental risk assessment and food safety assessment, if needed. I feel this sequencing of capacity building strategies and action plans may be helpful in many other countries too. Or not? Comments welcome!

p.s. the SOPs for confined field trials are available electronically - just let me know if you're interested.
posted on 2008-11-18 16:19 UTC by Mr. John Komen, Program for Biosafety Systems (PBS)
RE: Session 2: Capacity-building needs, gaps and priorities - how to focus? [#771]
As John Komen said, such experience is valid for other countries. In the case of Cuba, something similar has occurred. We dealt with some field trials in a first stage. In fact we still are in that stage.  Those field trials were not a consequence of an act of import, but all of them were LMOs produced in the country. The fact of focusing on this step has allowed us, in addition to what Ms. Komen said in his message, an improvement of our authorization system that includes the decision making process, in which the risk assessment, is the core. As a consequence, we are now in a better position to deal with a general release, either nationally or coming from abroad if that is the case. Nevertheless, national capacities must be created in that stage concerning, mainly, the adequate infrastructure for making some tests needed. This means that an accredited and impartial laboratory is very important so the competent authority can make a successful risk assessment process. For the time being and most of the time, the facilities directly or indirectly involved in the research of a specific LMO make this kind of tests. We are working on it. Once this aspect is resolved we can say that our capacity in this stage would be complete.
posted on 2008-11-18 20:13 UTC by Lic. Lenia Arce Hernandez, Centro Nacional de Seguridad Biológica
RE: Session 2: Capacity-building needs, gaps and priorities - how to focus? [#816]
As John Komen says, in many countries the needs are multiple and they need to choose where to star.  It is important to also well define the target audience to ensure that resources are utilised most effectively to their best result.

It is important to talk about the concept of risk to the general public and the press and to put it in their daily life context, but this discussion will be very different from the highly technical one required for the commercial approval for environmental release or for a field trial.
posted on 2008-11-28 13:02 UTC by Ms. Esmeralda Prat, CLI representation
RE: Session 2: Capacity-building needs, gaps and priorities [#800]
My name is Liliana Tovar and I work with GMO regulation at the Ministry of Agriculture in Mexico. Currently we have a limited staff to perform all the activities related with GMO, the same staff have to take care about the administrative procedures and also about the evaluation of risk analysis and the monitoring. This have provoked certain delays concerning the steps to perform the risk analysis and the monitoring. However, this have been fruitful for us, because we have detected a lot of needs for the area. For example:
*We need more human and financial resources.
*Training with international organisms and goverments that are more advanced than us.
*A certified laboratory for the detection and monitoring of both GMO with intended use for environmental release and accidental release.
*A unique staff to perform the evaluation of risk analysis, another staff to do the monitoring, and another staff to take care about the legal procedures, at least.
RE: Session 2: Capacity-building needs, gaps and priorities [#802]
Moldova has limited practical experience in risk assessment and risk management of LMOs, has been not received or approved any applications for import or release of LMOs.  At present Moldova is at the mid-term ongoing work for capacity building activities implementing NBF, some efforts to establish an efficient capacity building infrastructure for RA made or in the process of performing. The national Law on biosafety stipulates requirements for RA/RM based on scientific data as a part of the decision making for GMOs.  A draft regulation on Risk assessment on environment and human health is waiting for approval; a laboratory has been equipped for GMO detection; two books published in national language that is related to the GMO plant detection methods and the techniques for laboratory bio-security.  At the same time I should mention the following limitations and needs that the country faces in this context:
Country level:
-  development of  regulations and guidelines on risk assessment and risk management for various LMOs ( plants, animals, microorganisms);
-  training of experts/specialists, inclusive short term and long term educational courses, as PhD and masters programmes;
-  development of standards for procedures and criteria for LMO risk assessment, inclusive of methods and national standards for LMO detection and quantification;
-  the laboratory need to be accredited for LMO detection and analysis;
-  the methods for LMO detection have to be validated;
-  exchange of  experience on risk assessment and risk management;
-  difficulties in finding and accessing relevant data and information for risk assessment and risk management (scientific publications, databases etc);
-   synergism between research institutions in providing RA;
-   strengthening of the regulatory and administrative systems to effectively facilitate risk assessment and risk management;
-   acquisition of sectorial laboratories in the field of plant protection, food safety and veterinary control with equipment and consumables;
-   exchange of experience;  
-   establishment of LMO monitoring and inspection systems;
-   regular education, training and experience sharing in risk assessment and risk management, monitoring of long term effects of LMOs, and parameters for LMO identification;
-   data and information to support risk assessments;
-   a common format for risk assessment summaries submitted to the BCH

Regional cooperation:
-    establishment of opportunities for regional cooperation and sharing of experiences in risk assessment and risk management;
-   establishment of sub-regional networks of experts on risk assessment and risk management;
-   organization of training workshops on risk assessment and risk management for experts and government officials;
-   organization of training courses for specialists in different risk assessment and risk management fields, including detection and sampling methods for different LMOs

I would express our interest to establish a good collaborative framework with the relevant international organizations as UNEP, EU, OECD, FAO, and regional research institutions and centers, as  ICGEB, EFSA, JRC that would be helpful for the countries in Central and Eastern Europe to harmonize approach and methods for RA/RM, post release monitoring and LMO detection.

Angela Lozan
posted on 2008-11-25 10:41 UTC by Angela Lozan