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Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6759]
Dear Forum Participants,

Thank you for registering for this online discussion. It is a pleasure to welcome you all.

This online discussion is a preparatory session for the second joint “Webinar of International Databases on Biosafety”, scheduled for 27 May 2015.

The first joint webinar, held in November 2014, provided an opportunity to many FAO Focal Points, CBD-BCH Focal Points and OECD delegates to learn who within in their country is working with the other Biosafety related databases. During this webinar many participants expressed a strong need for strengthening coordination and communication mechanisms at the national level.

During the next two weeks we invite you to share your insights and experiences on this within the broad community of Focal Points/Contact Points. The outcome will then be introduced at the webinar in May. All of you will be invited to the webinar.

Below are some guiding questions to help focus the discussion:
• In your country, what worked well in terms of inter-agency coordination and communication  and what did not?
• What formal mechanisms/structures are put in place in your country to promote inter-agency coordination and communication? How about informal mechanisms?
• How do you think international organizations such as FAO/CBD/OECD can help you in improving the national coordination mechanism in your country?

Thank you for sharing your views and we look forward to hearing from you.

Best regards,

Masami and Ward, FAO
Manoela and Dina, CBD
Peter, Bertrand and Taka, OECD
posted on 2015-04-27 01:03 UTC by Dina Abdelhakim, SCBD
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6773]
Bio-safety is a cross-cutting issue which needs active participation from relevant stakeholders.

In Cambodia, a National Steering Committee for Bio-Safety (NSCB) was established as a formal mechanism to engage and promote inter-agency communication and coordination. More information on the Cambodia NSCB can be found at the Cambodia BCH website (http://www.bch-moe.gov.kh). Informal mechanisms in the country barely exist.

Challenges faced by Cambodia to promote inter-institutional coordination and communication on bio-safety are as follows:
• Ministry of Environment (chairs of NSCB) is currently undertaking major institutional restructuring. This means that some existing mechanisms can be dissolved for instance it is uncertain about the status of NSCB after restructure completes.
• Mainstreaming of bio-safety into sector institution’s policy and strategy is difficult (e.g., how to do it)
• Awareness raising, education and campaign on bio-safety to improve the public understanding is limited
• Capacity of laboratory and public staff at the national and sub-national level for detecting and monitoring LMOs is very limited
• Mainstreaming and implementation of biotechnology/bio-safety into national undergraduate curriculum is difficult

To overcome the above-mentioned challenges, Cambodia needs capacity development and laboratory equipment/ materials for producing GM crops/animals, and identification, detecting and monitoring LMOs. Raising awareness of the public especially grass-root community on food safety, animal and plant safety also needs to be strengthening.        

Loeung Kesaro
NFP for Cambodia BCH
posted on 2015-04-27 10:12 UTC by Mr. Loeung Kesaro, Cambodia
This is a reply to 6773 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6779]
Dear Forum participants
In Niger republic , National Biosafety Committee was estabished since 2005 This included government institutions, research and training institutes, civil society, consumers and farmers associations, for biosafety activities coordination, public awareness and information A division of communication was established in the ministry of Environment for the implementation of strategy and plan communication THe main challenges are the lweak  human  ad material resourcesfor of  the  National Biosafety Laboratory suggesting the need of capacities building for this laboratory and information, training activities for national stakeholders
Best regards
Dr Gado
posted on 2015-04-27 13:13 UTC by Mr. Mahaman Gado Zaki, Niger
This is a reply to 6779 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6784]
Dear all,

Thank you Loeung and Gado for sharing your experience in Cambodia and Niger. I am Masami from FAO and I mainly work on safety assessment of food/feed derived from biotechnology. I am reading your posts with a great interest. I thought Loeung's point on the difficulty in mainstraming of biosafety into each sector's policy/strategy is a very good one.

I would be also interested in learning how food safety/health officials and environment/biosafety officials are communicating (well) at the national level in terms of biotechnology and GMO related work/activities. Also what challenges are you facing in terms of coordination?

Thanks and warm regards,
Masami Takeuchi
FAO GM Foods Platform Manager
posted on 2015-04-27 14:40 UTC by Dr Masami Takeuchi, Food and Agriculture Organization of the United Nations (FAO)
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6786]
Dear forum participants.

This is a very important issue for the right implementation of Biosafety. As we agree with Cambodia representative concerning biosafety is cross-cutting issue, a National Coordination Mechanism has been implemented in Cuba. This Mechanism is composed ( from the structural point of view) by the regulatory bodies or agencies which competence includes some relevant aspects for biosafety. Even though there is just one national authority in Cuba regarding biosafety, some agencies strongly involved in the regulation of the biological risk in a broad sense ( human health, veterinary and plant protection agencies) play a key role in terms of biological risk management . The functional coordinations among these authorities for integration purposes is the core of the mechanism. Coordinations aim at integrating both, legislation and control mechanisms if it is possible. So, the harmonization of the decision making process in terms of LMOs  and other biological categories in which alien species and pathogenic biological agents are included, become crucial for attaining a more dynamic and coherent control system at a country level. The point is that all the authorities take part of the process in an organized way, when faced with a case involving more than one agency. In that sense, relevant documentation for the process and timing have to be harmonized. Legally binding agreements are necessary among the different authorities, so the final decision made, results in a technically stronger decision.

Juan C. Menendez de San Pedro Lopez
NFP for Cuba BCH
posted on 2015-04-27 17:26 UTC by Mr. Juan Carlos Menéndez de San Pedro López, Cuba
This is a reply to 6786 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6787]
Dear Fórum online
In Mexico what has worked well in terms of interagency coordination, is the CIBIOGEM. The CIBIOGEM is an Interministerial Commission which aims to formulate and coordinate the policies of the Federal Public Administration concerning biosafety of GMOs. It is composed of the heads of the Ministry of Health; the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA), the Secretariat of Environment and Natural Resources (SEMARNAT), the Ministry of Public Education (SEP), the Secretariat of Finance and Public Credit (SHCP) and Ministry of Economy (SE) and the Director General of the National Council of Science and Technology (CONACYT).
Meanwhile The Ministry of Health participates in the plenary of the CIBIOGEM; the Technical Committee and care working groups in CIBIOGEM.

The authorization of GMOs, the Ministry of Health meets the administrative act to authorize or reject applications for Genetically Modified Organisms for human consumption, intending to market and import for marketing in our country; and their use for public health purposes or bioremediation.
The authorization process of GMOs, is carried out according to the powers of the various committees within the COFEPRIS based on the law and internal regulation. Authorization has a main component Risk Assessment is based on scientific criteria and attached to the Law on Biosafety of Genetically Modified Organisms and Regulations, which determines if it is issued or the authorization is rejected.                                   

M en C. SERGIO SARABIA MORÁN
Biotechnologist
COFEPRIS the Ministry of Health Mexico
posted on 2015-04-27 18:09 UTC by M en C SERGIO SARABIA MORAN, Mexico
This is a reply to 6787 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6789]
POSTED ON BEHALF OF OSSAMA EL-TAYEB
---------------------------------------------------------

Dear Dina and participants;
I was involved with the negotiations of the CPB since 1997 and it was a rich experience.  In Egypt, I saw "conflicts" between different interested elements which are yet to be resolved.  The main problem arises from "elements" which see the CPB as a threat to an "establishment" which is keen on maintaining its "empire"!  I am not sure if this is frequently met in other countries and how this was dealt with.  There are several entities with an interest in issues raised by the Protocol: environment, health, agriculture, trade, standards -setting offices, public information exchange, NGOs  etc. The strongest "actors" are those connected with foreign representatives of countries with strong interests in keeping the market free from "obstacles" (such as the CPB) which restrict imports of GMO commodities, legal or illegal. Egypt does not produce GMOs or allow their import "legally". As a result foreign representatives actively support illegal imports and attempt to influence "decision-makers" to avoid legal restrictions.  This may be a problem of "governance" but also reflects foreign influence on policies and implementation of laws - which may and may not be a common problem in other "developing" countries.  It may also be a reflection of the fact that relations between countries are not governed exclusively by "international law' but also by the balance of power (trade, economic and also military) between countries!  The world is not exactly "fair or equitable" and we have to keep this fact in focus when we draft international laws and treaties.
This statement is only an "opener" !
Ossama El-Tayeb, NFP-CPB, Egypt
posted on 2015-04-27 18:19 UTC by Dina Abdelhakim, SCBD
This is a reply to 6789 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6797]
In the Bolivarian Republic of Venezuela, works similar to Nigeria and Mexico. First of all there is a National Biological Diversity, which is framed in the National Strategy for the Conservation of Biodiversity (ENCDB) and National Action Plan 2010-2020 framed in the Historic Objective "V" of the Law Homeland plan 2013-2019. This ENCDB contains a strategic line called: Control and supervision of Genetically Modified Organisms. We also have Management Act of Biological Diversity and the National Biosafety Committee, created by Decree in 2006 where the institutional framework of the various competent national authorities is established.
posted on 2015-04-27 20:37 UTC by Ms. Edis Solorzano, Venezuela (Bolivarian Republic of)
This is a reply to 6797 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6799]
Dear Dina, and participants,
As mentioned and in addition of the comment made by  our collegue Sergio Sarabia,
During the year 1999 in Mexico by Presidential agreement the Inter-Secretarial Commission on Biosafety of Genetically Modified Organisms was created. The Commission coordinates the policies and federal regulation of activities related to Genetically Modified Organisms (GMOs) such as: production, import, export, mobilization, transportation, release into the environment, consumption, and general use of GMOs and their products.
The Commission is made up of the heads of the Ministries of Health, Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA), Environment and Natural Resources (SEMARNAT), Finance and Public Credit, Economy and Public Education, and the General Director of the National Council of Science and Technology (CONACYT).
The Ministries of Health, SEMARNAT and SAGARPA are the three entities most directly involved in policies concerning the biosafety of Genetically Modified Organisms (GMOs). The mexican regulation framework is established in the Law on Biosafety of Genetically Modified Organisms, which states that the Commission aims to promote coordinated actions of Government agencies. CIBIOGEM receives support from the Executive Secretariat of CIBIOGEM, the Technical Committee, the Scientific Advisory Board and the Joint Advisory Council.
The Executive Secretariat promotes and coordinates the actions of the government ministries the integrate the CIBIOGEM and their consultative bodies, in order to generate certainty in society regarding the use and activities related to Genetically Modified Organisms (GMOs) and assit in the proposals of policies and mechanisms that ensure that the products of biotechnology are used in favour of national interests. It also aims to establish mechanisms for safely and public participation and oversees the National Information System on Biosafety (an electronic platform for information Exchange and awareness). In addition the Executive Secretariat is the National Focal Point of The Cartagena Protocol and BCH, and is in charge to share the information to the Biotrack-OECD data base and the GMO Platform- FAO.

Mexican regulation contains three administrative acts:
1. “Notifications” for Teaching and research (these notifications are included in the National Information System on Biosafety http://www.conacyt.gob.mx/cibiogem/index.php/sistema-nacional-de-informacion/registro-nacional-bioseguridad-ogms )

2. “Permits” for environmental release in three phases: Experimental, Pre-commercial and Commercial – SAGARPA and SEMARNAT are the authorities in charge.
--The Executive Secretariat coordinates and update the information available with regards to the mexican profile (BHC, FAO, and OECD).

3. “Authorizations” for GMO used for Food, feed, and processing, as well as Bioremediation or Public health – SECREATRY OF HEATLH is the competent authority responsible for this act.
--The Executive Secretariat coordinates and update the information available with regards to the mexican profile (BHC, FAO, and OECD).

The mechanisms used by the Executive Secretariat are usually mediated through oficial notifications, or sometimes just an e-mail requesting considering the time and the information need. 
Working groups and specialized committes are stablished for coordinating actions on specific topics whenever this is requiered.
Additional coordination work integrates multidisciplinary teams as reported from the National Biosafety Networks.
posted on 2015-04-27 23:36 UTC by Sra. Rosa Inés González, Mexico
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6803]
Upon adhering to the Cartagena Protocol on Biosafety, Mauritius drafted a Genetically Modified Organisms (GMO) Act which was passed in the National Assembly in April, 2004 to cater for GMO issues. The GMO Act establishes a National Biosafety Committee (NBC) which has the main objective of advising the Ministry on all aspects pertaining to GMOs with representatives of various Ministries. Thus, in the local context, the NBC is the formal mechanism through which the different local stakeholders interact. To further advance inter-agency interaction, a technical working group was set up under the chairmanship of the Chairperson of the National Biosafety Committee and comprising representatives of the Ministry of Agro-Industry & Food Security, FAREI, MSIRI, State law Office, Association des Consommateurs de l’Ile Maurice to work on relevant regulations under the GMO Act.
posted on 2015-04-28 05:44 UTC by Dr Shalini Amnee Neeliah, Dairy Chemistry Division, Min of Agro-Industry
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6808]
Dear all forum participants,

Malaysian Biosafety Act 2007 is drafted to be in line with the National Biodiversity Policy (1998) and the National Biotechnology Policy (2005). Under this Act, a National Biosafety Board (NBB) was formed in March 2010 and its members comprise of representative from seven different ministries related to environment & natural resources, health, commodities, agriculture, trade and science, technology & innovation. One of the NBB functions is to establish mechanisms to facilitate the collection, storage and dissemination of data relating to LMOs and biosafety. These formal mechanisms facilitate inter-agency communication on biosafety-related issues.

However, developing an effective coordination mechanism among the different government agencies and clearly identifying their roles and responsibilities in dealing with biosafety issues have been biggest challenges. Some other challenges include: limited experience in risk assessment and evaluation, inexperience in drafting biosafety regulations and guidelines and the low level of awareness of biosafety issues among the agencies involve especially at state level.

From our experience, it is clear that relevant agencies involvement at every stage of the biosafety systems development is crucial for the success of its implementation and coordination. Apart from that, continuous engagement with these agencies during the decision making process are very important in getting their cooperation during the post decision monitoring works/activities. At institutional level, the structure can be reviewed over time depend on complexity and burden of works. This is important especially to support the coordination of the implementation of biosafety regulations which are cross-sectorial and involve many states.

I believe in some countries biosafety is relatively unknown or a neglected subject and runs on a one man show or so. It needs skilled people with capabilities to engage with and convince the authorities in charge of national policy development (e.g. on environmental, agricultural or biotechnology). Perhaps a guidance document is needed on how to effectively integrate biosafety into relevant national policies. It has to have clear facts and arguments on important parameter that can convince authorities. This is where international organizations can play their roles and it probably could be effectively achieved through regional cooperation and sharing of experiences or development of regional networks among different actors and experts.

Regards,
Johnny Andrew
BCH NFP for Malaysia
(edited on 2015-04-28 09:51 UTC by Mr. Johnny Anak Andrew)
posted on 2015-04-28 09:48 UTC by Mr. Johnny Anak Andrew, Ministry of Natural Resources & Environment
This is a reply to 6808 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6822]
POSTED ON BEHALF OF JONATHAN MUFANDAEDZA
----------------------------------------------------------------

Biotechnology and Biosafety issues are cross-cutting and involve many stakeholders.

In Zimbabwe, the National biotechnology Authority (NBA) is the designated competent authority for biotechnology and biosafety matters in Zimbabwe (http://www.nba.ac.zw). Through our ACT, a formal mechanism to engage and promote inter-agency and stakeholder communication and coordination is in place. We have the  CBD focal point in the Ministry of environment water and Climate and the NBA as an Agency focusing on Biotechnology and Biosafety issues.

Challenges faced by NBA.

•National reference Biosafty laboratory and laboratory equipment for identification, detecting and monitoring LMOs and capacity development is needed.
• Mainstreaming of biosafety into national biodiversity strategic plans and in sector institution’s policy and strategy is difficult (e.g., how to do it)
• Mainstreaming and implementation of  Biosafety into  undergraduate curriculum
• National biosafety awareness raising, education and campaign to improve the public understanding.
• setting up a national biosafety office to effectively promote and coordinate biosafety information and communication

If the overall objectives of the Cartagena Protocol on Biosafety are to be met in Zimbabwe,  a national reference Biosafty laboratory and laboratory equipment for identification, detecting and monitoring LMOs and capacity development is needed. Setting up of a biosafety office to coordinate national biosafety awareness in all sectors of our economy is a prerequiste.

Dr Jonathan Mufandaedza
NFP for Zimbabwe BCH
posted on 2015-04-28 19:34 UTC by Dina Abdelhakim, SCBD
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6828]
Dear forum participans;

In addition of the comments made by Sergio Sarabia and Rosa Gonzalez, Mexico has areas of opportunities to improve interagency coordination, highlighting the work generating mechanisms to avoid redundant procedures and duplication of work among government agencies which are involved on taking decisions in biotechnology, in order to optimize the exchange of information and official documentation, shortening the resolution.

An alternative to address this problem is the generation of an electronic system that helps manage real-time shared files and received by the different institutions involved in the resolution process requests for release of genetically modified organisms.
posted on 2015-04-28 22:37 UTC by Marco Antonio Cervantes Garcia, Mexican Agroalimentary Health, Safety and Quality Service (SENASICA)
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6833]
Dear Dina, and participants,

As we all know, biosafety is a multidisciplinary subject and require involvement of different stakeholders.
Based on Iran biosafety law which was passed by parliament on 29 July 2009, National Biosafety Council (NBC) was formed under the chairmanship of first deputy of President and membership of:
Ministries of Science, Research and Technology, Health and Medical Education and Agriculture; Director General of Department of Environment; one specialist from scientific societies (NGOs), one person form the scientific members related to biosafety in universities, one person from the members of agriculture, water and natural resources commission and one person from the health and medical commission of the parliament.
One of NBC responsibilities is Coordination between the legal functions of competent administrative bodies.
Article (4) of Iran biosafety act specifies three competent authorities (Ministry of Health and Medical Education, Ministry of Agriculture and Department of Environment) and their functions and responsibilities related to issuing permission for release, import, export, transport, transboundary movements of all living modified organisms .
Apart from that Iran National focal point has established an advisory committee comprise of the representatives of above ministries and a few other stakeholders such as Ministry of Industry, Mine and Trade, Ministry of Economic affair and Finance and Iranian National Standard Organization; BCH focal point is the other member of this advisory committee. This committee held a session at least once or twice a month to discuss about different issues related to biosafety and CPB notifications.
Moreover, Iran Biosafety Foacl point  is the chair of codex committee on foods derived from biotechnology in Iran.
However, there are still some limitations in some important areas such as: establishing reference and well equipped laboratories for risk assessment and LMO identification; trained personnel in customs to control the borders from unapproved and illegal GMOs; improve nBCH to facillitate information sharing among different stakeholders; train university students and scientists to handle biosafety issues scientifically, and public ducation. 

Kind Regards,
Nasrin Esmaeilzadeh
IRAN BCH Focal Point
posted on 2015-04-29 07:17 UTC by Ms. Nasrin Sadat Esmailzadeh, Ministry of Science, Research and Technology
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6834]
In Madagascar we still have significant challenges on intersectoral coordination in the implementation of the Biosafety Protocol.
Certainly the National Biosafety Committee is in place, but in this committee rather sit technicians who have no real impact on the definition and conduct of sectoral policies. Those policies do not generally recognize the national biosafety policy and much less the national framework that goes with it.
We had an example of introduction of GM maize in Madagascar in 2008 when the Ministry of Agriculture has given the GMO seed import authorization irrespective of the provisional national framework that already existed at the time. Customs services have allowed the GM seeds enter the territory without informing anyone. Officials at the regional and district level have also given the plantation permission given that they lack information ...The Ministry of Environment, as the competent national authority was not aware of.
Such cases may happen again as long as a robust sectoral coordination is not in place. This requires awareness of high level decision makers in all sectoral ministries. But the problem lies in the frequent replacement of these officials.
posted on 2015-04-29 08:02 UTC by M. Jean Roger Rakotoarijaona, Madagascar
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6835]
In Germany and the European Union, risk assessments for LMO field trials, LMO cultivation and LMO intended for direct use as food, feed, or for processing (ffp) are handled in a transparent and participative process based on established legal frameworks. BVL [Federal Office of Consumer Protection and Food Safety] is the German competent authority that issues a decision at national level (field trials) or delivers the German comments on risk assessments for EU-wide decisions (cultivation and ffp). By law, both, decisions and comments, have to consider contributions of several other national institutions with scientific expertise in relevant areas of risk assessment. For reasons of practicability and in order to handle disagreements an administrative agreement on the procedures (e.g. timelines) was developed and mutually accepted by the institutions involved.
These established procedures guarantee that formally correct decisions and statements are based on broad scientific considerations within the existing legal framework and respecting existing time constraints.

Best regards,
Joachim Bendiek
BVL, NCA Germany
posted on 2015-04-29 09:17 UTC by Dr. Joachim Bendiek, Bundesamt für Verbraucherschutz & Lebensmittelsicherheit (BVL) - [Federal Office of Consumer Protection & Food Safety]
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6844]
Dear all,

As regards the regulatory biosafety framework, there is still no legislation relating to LMOs in Morocco. Only a circular from the Department of Agriculture to prohibit the introduction of products of LMOs is in force. In this context, imports of LMOs seed is prohibited, except those intended for animal feed with certain restrictions. The experimental field crops and crops that are intended for marketing and scientific research relating to LMOs and middle confined trials are not yet permitted.

However, there are many laws and regulations indirectly related to modern biotechnology, including those regulating the sanitary and phytosanitary control, protection and enhancement of the environment, those relating to environmental impact studies , etc.
However, in the GEF6, Morocco plans to prepare a draft law to establish the regulatory framework for biosafety.

Furthermore, Morocco has designated a competent national authority that is a public agency under the Department of Agriculture.

Best regards
Mr Mostafa Madbouhi.
posted on 2015-04-29 14:25 UTC by Mr. Mostafa Madbouhi, Morocco
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6846]
According with the article 108 of the Law on Biosafety of Genetically Modified Organisms, in Mexico exist a National System of Information on Biosafety with the objective of organize, update and communicate information related to biosafety. This system is regulated by the Executive Secretariat of the Inter-Secretarial Commission on Biosafety of Genetically Modified Organisms and gather information of public character related to the contained use of GMOs, environmental release and consumption authorizations.

In Mexico, the Executive Secretariat of the CIBIOGEM is responsible of the inter-agency communication through the integration and coordination of working groups on specific topics related with biotechnology and the biosafety and where the participants from different governments agencies interchange knowledge and experiences, this activity strengthen the participation and position of Mexico on issues of genetically modified organisms at international forums like NABI, CAS, APEC, TTWG, GLI, LLP and COP MOP.

Concerning the resolution of legal issues relating to genetically modified organisms, each government agencies applies the Law on Biosafety of Genetically Modified Organisms and its own internal regulations in order to generate different mechanisms for interagency communications that allow its gather inputs and elements from others competent authorities for the decision making.

Another mechanism involved in the interagency communication is carried out in the development of the Official Mexican Standards derived by the Law on Biosafety of Genetically Modified Organisms, coordinated by diferents subcommittees and integrated by specialist and governments authorities.
posted on 2015-04-29 14:53 UTC by Mr. Rafael Romero, Mexico
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6848]
In addition to the comments of Rafael and Marco from Mexico, I consider that international organizations such as FAO/CBD/OECD can help the inter-agencies coordination, in different form like the mentioned below:

• Generation of international guidelines where specific topics on biosafety and biotechnology are adopted in order to facilitate the harmonization of specific issues, recognize equivalences and evaluate the implementation of multilateral instruments for decision-making process on biotechnology related issues.

• Generation of workshops and forums where government representatives exchange experiences concerning with topics related to biosafety and biotechnology.

• Creation of communication channels in order to get expert opinions from different specialist on issues concerning to the risk analysis.

• Offer multidisciplinary training to government representatives for capacity building in biotechnology and biosafety.

• Updating databases and reference documents to enable the decision making process with the latest information.
(edited on 2015-05-06 15:55 UTC by SR PEDRO MACIAS-CANALES)
posted on 2015-04-29 15:31 UTC by SR PEDRO MACIAS-CANALES, Mexico
This is a reply to 6833 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6849]
Dear Forum participants,

The legal and regulatory biosafety framework for Rwanda is not yet there. There is a draft law and biosafety guidelines. We have started the process for review prior to the introduction to the parliament for approval. The draft provides that LMOs will be allowed if there is a risk assessment before LMOs introduction on the country.
However, the country has other laws which, without being specific, are applicable. Those are for example the Biodiversity law, the environment protection law and the law on import of animals and plants. Under all of the mentioned, LMOs are not allowed in Rwanda.  
Regarding the interagency communication, challenges are many and it is because the framework is still in process. Even the capacity needs to enhanced for efficient communication.
Thank you.
posted on 2015-04-29 15:35 UTC by Mr. Emmanuel Kabera, Rwanda
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6885]
POSTED ON BEHALF OF YERLAN MIRKHAYDAROVICH RAMANKULOV
----------------------------------------------------------------------

Dear forum participants,
Issues of interagency coordination and communication are certainly the most essential components of safe and effective functioning of the Biosafety system.

Functions on separate issues of biosafety in Kazakhstan are divided between several ministries and agencies - Ministry of Agriculture, Ministry of Education and Science, Ministry of Public Health and Social Development, Ministry of Energy, State Revenue Committee of Ministry of Finance. As for promotion of inter-agency coordination and communication in Kazakhstan, there were established the following mechanisms/structures: the national Focal point (Ministry of Agriculture), the competent national authority (Ministry of Education and Science) and the Focal point for the clearing-house mechanism on biosafety (National center for Biotechnology).

However, the mechanism of effective coordination and communication between these stakeholders is not yet installed. The potential of the interagency coordination and communication is currently not sufficient and it needs to be developed and strengthened.

As can be seen from the information given by participants, the similar problems are typical for many countries, and that is why international organizations such as FAO/CBD/OECD could provide a technical assistance for improving national coordination mechanisms through the implementation of regional projects, workshops or trainings for involved agencies and authorities and through formulation of guide with information about structure layout for implementation of  interagency coordination based on successful examples.

Dr. Yerlan Ramankulov
NFP for Kazakhstan BCH
posted on 2015-04-30 16:03 UTC by Dina Abdelhakim, SCBD
This is a reply to 6885 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6888]
Dear Dina, dear all,

thank you for this joint initiative of FAP-CBD-OECD Biosafety units to discuss here the possible interactions and future initiatives to promote synergy and cooperation, better communication and harmonization.

In Moldova the inter-agency coordination and communication is mainly ensured by the National Biosafety Commission, which is interdepartmental advisory body to the National Competent Authority - Ministry of Environment, both are nominated by the Governmental decisions. The Commission has inter-sectorial representation involving environmental, economy, agriculture, health care central administration bodies as well as  academy of sciences, universities ans NGOs. During the appointed meetings and inter-sessional periods various coordination issues are part of the Commission activity, including regular sectorial reporting and monitoring over LMOs, scientific risk assessment, consultation of legislative process, information exchange etc.

The National Biosafety focal point is also a coordination mechanism in the field of Biosafety. The FP is supported in his activity to coordinate initiatives and national reporting by the nominated working group that brings partners from the environmental, agriculture, academic sector and nonguvernamental society.

The National BCH system and website offers instrumentarium for maintenance of the national Biosafety database, make available access to the biosafety information and facilitate  information sharing, intersecrorial communication, public information, education and decision making. 

However, some limitations and constrains are observed due to limited coordination and communication between sectorial inspectorate services, ex. ecological inspection, health care inspection, agriculture/phytosanitary and veterinary control services, food security, forestry agency, custom control etc.

Various academic institutions and university laboratories has provide their internal data base and scientific reports that is not available for intersectorial communication or open for public.

A number of national electronic database in the related fields has been elaborated within various institutions, but usually are not available for public and not been integrated in a common IT system.

I may also mention not enough communication between the FAO, the UN and other international initiatives at the national level related to biotechnology/biosafety/food safety issues.

Poor harmonisation of the biosafety informational systems, regulation and procedures at the regional level is also an obstacle for efficient communication and cooperation.

In this context I would support suggestions made by  Mr. PEDRO MACIAS-CANALES, Mexico.

I find very useful  and important to join efforts and initiatives with the support of the mentioned international agencies in advising countries to consolidate their capacities to improve informational exchange, make efficient national inter-sectorial and regional communication and coordination mechanisms, to transpose the international guidelines and standards at national level, to maintain efficient national database etc.

A number of regional and sub-regional thematic workshops and trainings on specific topics of Biosafety, as well as on-line forums and discussions would be a great opportunity to reach success.

It is very important to make available and easy accessible for national biosafety partners and stakeholders the huge data and relevant guideline materials and reference documents that are uploaded in the websites of the FAO, CBD and the OECD.

Elaboration of Guidelines, establishing a linkage and inter-conectivity between the specific informational database of the BCH, FAO Aricultural Biotechnology Forum and the OECD Bio-track, as well as reference materials and news  would help the countries very much in their efforts to ensuring efficient biosafety and meeting the international agreements.

Best regards,
Angela Lozan
MD
posted on 2015-04-30 18:57 UTC by Ms. Angela Lozan, Republic of Moldova
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6889]
Dear Colleagues,

As to many other countries, biosafety issues in Lebanon involve several national authorities including the Ministry of Environment which is the Focal point for the CPB and clearing-house mechanism, the Ministry of Agriculture, Ministry of Health, Ministry of Economy and Trade, and Ministry of Education. Till now the coordination between the different officials is rather timid.

However the draft decree to implement the provisions of the CPB in Lebanon was lately approved by the Council of Ministers. It proposes the establishment of a National Biosafety Committee which includes representatives from all relevant institutions. Hopefully this body will be the dynamo for the coordination between national agencies and officials and will also monitor the biosafety assessment of GMOs on case by case basis. It is evident that international organizations such as FAO/CBD/OECD could provide an important assistance for improving national inter-agency coordination mechanisms through the implementation of regional projects, workshops and trainings.

Lamis Chalak
Focal Point, FAO GM Foods Platform
Lebanon
posted on 2015-04-30 19:03 UTC by Dr Lamis Chalak, Lebanese University
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6899]
Dear Forum Participants,

Thank you the Secretariats for organizing this online forum.

In Japan, six ministries are responsible for environmental risk/safety of LMOs according to domestic biosafety law; the Ministry of Environment (MOE), the Min. of Finance (MOF), the Min. of Health, Labor and Work (MHLW), the Min. of Agriculture, Forestry and Fisheries (MAFF), the Min. of Economy, Trade and Industry (METI), and the Min. of Education, Science and Technology (MEXT).
As for food safety of LMOs, another section in the MHLW and the Food Safety Commission are involved in it according to the Food sanitary law.
As for feed safety of LMOs, another section in the MAFF deals with it according to the Feed safety law.

Among above six Ministries responsible for the environmental risk/safety, there is an inter-agency group to share information and discuss biosafety issues. The meeting of this group is coordinated by the MOE and held from time to time when any Ministry proposes. Usually person in charge, not high level official, gets together, has frank discussion on challenges and shares similar experiences and lessons there, I think it works well.

Apart from that, there is a biosafety advisory committee which consists of experts and gives scientific opinions on environmental risk/safety assessment of LMO.

Between different safety aspects, e.g. environmental safety – food safety, there is only informal mechanism in Japan. We Japanese government officials move to another section every two or three years, but in many cases a predecessor takes and introduces their successor to all relevant officials even in other ministries. It keeps us updated, in other words it enables us to know who is our counterpart and their contact details. (I understand such business custom differs from country to country.) Usually it works well but in case we don’t need to contact each other for years, there may be a bit difficulty in finding the responsible officials and communicating with them.

To avoid such challenge I mentioned above, it may be of help to us if international organizations provide a list of all contact points in that country. To do so, the organizations encourage us to update the list regularly and we also need to cooperate. Maybe I said the similar thing in the last webinar and agree this will solve only a part of challenges in inter-agency coordination and communications, but it will be the very first step to move forward when officials from different ministries are registered in several lists.

By the way, as some previous referred to challenges in mainstreaming biosafety issues in their national plan or strategy, I am introducing a report for the MOP7 in Korea last year though many of you might have already been aware of it. “The Synthesis Report on the Experiences and Lessons Learned in the Implementation of the Cartagena Protocol on Biosafety” is available on the BCH [UNEP/CBD/BS/COP-MOP/7/7]. There was a half-day special session on this topic and the video have been uploaded on the BCH so we can also watch presentations about actual lessons from various countries at the MOP7.

Best Regards,
Kazuyuki SUWABE, MAFF, Japan
posted on 2015-05-01 07:28 UTC by Mr. Kazuyuki SUWABE, Japan
This is a reply to 6899 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6919]
agree
posted on 2015-05-01 18:29 UTC by Mr. Ossama El-Tayeb, Egypt
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6921]
POSTED ON BEHALF OD GALINA MOZGOVA
------------------------------------------------

Dear Forum participants,

The most important provisions of GMO safety in Belarus are presented in the Law “On Safety in Genetic Engineering Activity” of 2006, which together with the acts of the current legislation and other developed legal documents, forms the basis of the biosafety legal framework and also describes the key bodies involved in this area, their duties, coordination and communication between them. State Bodies responsible for implementation of biosafety issues concerning GMOs: Ministry of Natural Resources and Environmental Protection (which coordinates measures to ensure safe genetic engineering activities and at which the interdepartmental Coordination Council on GMO Safety Issues operates), Ministry of Agriculture and Foodstuffs and Ministry of Public Health. At the State Scientific Organisation The Institute of Genetics and Cytology at the National Academy of Sciences of Belarus National Coordination Biosafety Centre and National Coordination Centre for Access to Genetic Resources and Benefit-Sharing were established and operates. CBD and CPB National Focal Point in the Ministry of Environment, BCH Focal Point and FAO «GM-Platform» Focal Point (since 2014) at the Institute of Genetics and Cytology are working in collaboration and the number of issues are solving jointly.

From the other hand, such an important biosafety areas as risk assessment, release of GMOs into environment for field trials, monitoring of GM-organisms in the environment are relatively new for the organizations and people involved in the decision-making; introduction into environment and risk assessment before large scale GM release has never been provided as no GM-plants has been approved for commercial growing; and finally such an area as GM-detection goes through reforming because the GM threshold for products labeling has been changed from 0 to 0.9%. In spite of the fact that key organizations stated above are actively involved in GM-safety functioning as well as in educational process in multiply directions of GM-safety (through the workshops , trainings, databases replenishment ), a number of other administrative and institutional organizations are or will be involved in GM-safety, and the contingent will depend on the solving problem, so there are still strong need in education of the representatives of the agencies responsible for decision-making as well as the citizens who are interested in the decision-making on specific biosafety issues. I supporting also the point of view that for national biosafety system right operation, the proper involvement and coordination of all of the agencies and institutes relevant to particular biosafety sphere is also the common need. I see that collaborative trials in regional and interregional levels for good practice sharing in agencies coordination in particular GMO spheres with skilful organizations such as FAO/CBD/OECD could be productive to establish mechanisms of such coordination as well as training mechanisms.
posted on 2015-05-01 19:29 UTC by Dina Abdelhakim, SCBD
This is a reply to 6889 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6922]
POSTED ON BEHALF OF OSSAMA EL-TAYEB
----------------------------------------------

Dear Forum Participants;
Following the inputs from various participants is gratifying : I am not alone frustrated in the bush!  The fundamental factor hindering national implementation of the CPB in several developing countries is governance and conflicting interests of national actors.  In many cases such conflicts are motivated by foreign interests (sometimes domestic) often moving discretely behind national actors.  Lack of expertise and/or funding is not a significant obstacle.
Ossama El-Tayeb, NFP, Biosafety, Egypt.
posted on 2015-05-01 19:37 UTC by Dina Abdelhakim, SCBD
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#6996]
POSTED ON BEHALF OF SYED MAHMOOD NASIR
--------------------------------------------------

Dear All
While we in Pakistan are struggling to update the NBSAP we came to realize that the Bio-safety issues / Cartagena Protocol including the emerging issues of synthetic biology are to be addressed in the overall Biodiversity Strategy. We find that the later is such a vast and complex issues and at times leading to acrimonious debates that belittle the main issues of CBD i.e the 20 Aichi Targets. Furthermore the consultants who know CBD here hardly know CP and vice versa. This has increased the workload and reporting load of the under staffed NFP of CBD/ CP.  I would like to learn how other Parties are handling this issue
Many regards
Syed Mahmood Nasir
Administrative authority CBD / NFP CP
Pakistan
posted on 2015-05-04 17:42 UTC by Dina Abdelhakim, SCBD
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7005]
Dear All Forum Participants,

Thank you the Secretariats for organizing this online forum.

In Lao PDR, the official adoption of the Biotechnology Safety Law No. 017 from National Assembly was on 18 December 2013 and Promulgation of the president No. 058/PD was on 28 January 2014. Laos has also developed a National Action Plan on Biosafety and Biotechnology (2015-2020). 

The Biotechnology Safety Law defines the principles, regulations and measures on management and monitoring of biotechnology safety to ensure safety in research, development, handling, movement, and the use of Genetic Modified Organisms (GMOs) resulting from the use of biotechnology, which may result in having negative impacts on conservation and sustainable use of biodiversity, with a focus on the limitation and reduction of risks to the life and health of human beings, animals, plants and the environment that can be linked at the regional and international levels, and which contribute to national socio-economic development.

Under this Law, the Committee for Biotechnology Safety Administration
consists of i) The National Committee for Biotechnology Safety (NCB) and ii) the Technical Coordination Committee (TCC).
The NCB consists of 1. Minister of the Ministry of Science and Technology (MOST) as
president, 2. Deputy Minister of the Ministry of Natural Resources and
Environment as vice president, 3. Deputy Minister of the Ministry of Agriculture and Forestry as Vice-president, 4. Deputy Minister of the Ministry of Public Health as committee member, 5. Deputy Minister of the Ministry of Science and Technology as committee member and Chief of the Technical Coordination Committee, and 6. Other relevant Deputy Ministers as committee members.

One of the NCB functions is to improve or modify conditions, standards, manuals and procedures of the MOST and other relevant ministries in the implementation of biotechnology risk analysis; establish administrative mechanisms to ensure the appropriateness of concessions, distribution and filing of documents and information connecting to processes related to submitting applications, attached documents or other relevant materials. The NCB is also under the process of establishment.

However, some challenges include: clear definition of roles and responsibilities for NBC and TCC, deliver biosafety information to the organizations/the leaders, the low level of awareness of biosafety issues among the stakeholders, limited local experts in the field of biosafety, and limited experience in risk assessment.

I believe in some countries having similar issue, the sharing of experiences are importance, strengthened national biosafety committees with access to the necessary tools and resources, awareness raising, strengthened national human resources and facilities for risk assessment and management in the country. This is the international organizations could provide a technical assistance for improving national coordination mechanisms through the regional cooperation including regional project, a joint programme of human resources upgrading and of mutual technical assistance in specific areas, workshops or trainings for sharing experiences among countries of the region.
posted on 2015-05-04 22:03 UTC by Mrs Viengpasith Vanisaveth, Lao People's Democratic Republic
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7014]
Dear Forum Participants,

My name is Didier Breyer. Since 1995 I have been working as senior scientist in the Biosafety and Biotechnology Unit (SBB) of the Scientific Institute of Public Health (Brussels, Belgium). I am involved mainly in the scientific assessment of GMO applications. I am also involved in communication activities including publication of scientific papers and the development and management of web-based information exchange mechanisms (in particular http://www.biosafety.be). I am currently appointed as Belgian Focal Point for the Biosafety Clearing-House of the Cartagena Protocol.

First of all, let me thank those who organised this online forum and all the participants who already provided very interesting contributions.

In Belgium, competencies with regards biosafety-related aspects are shared between different authorities representing different institutional levels (federal state, regions, and communities). To avoid disparities between these different entities a harmonised implementation of the regulatory framework on biosafety has been done via a legal instrument called “Cooperation Agreement” (for more information, see http://www.biosafety.be/Menu/BiosBelg.html).
This Cooperation Agreement represents a formal mechanism supporting coordination and communication between the different administrative bodies involved in biosafety-related matters. In particular it establishes a single science-based biosafety advisory system, composed of the Biosafety Advisory Council, the Biosafety and Biotechnology Unit (SBB), and external experts from academic institutions. Thanks to this system, all biosafety-related aspects are assessed altogether in a coordinated way, independently of the specific regulation(s) and authority(ies) involved.
In addition to the Cooperation Agreement, other formal groups and committees (not always specifically dedicated to biosafety aspects) are in place to re-enforce inter-agency coordination and communication.

With regards to external communication the SBB has been since many years a major actor in the field. The website “Belgian Biosafety Server” (developed and maintained by the SBB) is the main communication tool used for this purpose and is largely recognised by the Belgian authorities as the central information-sharing system on biosafety in Belgium. Complementing specific information can also be found on some websites managed by competent authorities (for example http://www.ogm-ggo.be).

With regards to the work of FAO/CBD/OECD, efficient coordination and communication is also promoted at Belgian level by the fact that the SBB is directly involved in the BCH (as national focal point) and in the OECD (we are representing Belgium in the Working Group on Harmonisation of Regulatory Oversight in Biotechnology and in the Task Force on the Safety of Novel Foods and Feeds). FAO-related matters are more in the remits of the federal competent authority.

In my opinion international organisations such as FAO/CBD/OECD could help improving national inter-agency coordination and communication but making their own inter-relationship more efficient. For example by ensuring that relevant activities in one organisation are reported to national representatives of the other organisations. Or by streamlining and harmonising as far as possible data requirements in their respective databases.

Best regards,

Didier Breyer
posted on 2015-05-05 11:56 UTC by Mr. Didier Breyer, Belgium
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7023]
POSTED ON BEHALF OF AFZAAL AHMAD NASEEM
---------------------------------------------------

Dear All
From my experience as a regulator of the genetically modified organisms and their products under the exiting biosafety regulation in the country was established on very fragile basis that collapsed at the very minor jolts to the regulatory systems. Currently, no biosafety system is in place and all the stakeholders are extremely under pressure to sustain. It is hoped that system may be soon in place and work for the betterment of the modern biotechnology in the country. It is required that guidance and help may be provided, under such circumstances, how to efficiently and effectively the system may be kept in working. The culture of information sharing is very important for improvement of the implementation of the CPB under CBD in the country.
Best wishes and regards
Afzaal Ahmad Naseem
Pakistan
posted on 2015-05-05 16:15 UTC by Dina Abdelhakim, SCBD
This is a reply to 7023 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7042]
Thank you Ms. Dina and my colleagues for the active participation and exchange of experiences in this forum. 

Allow me to share information on the biosafety regulatory system in the Philippines which has been in existence for nearly 25 years and my experiences as the Secretariat of the National Committee on Biosafety  of the Philippines (NCBP) and the Department of Science and Technology Biosafety Committee (DOST-BC)

In my country, the use of genetically modified organisms from laboratory to greenhouse to field testing up to commercialization (GMOs) is regulated by the NCBP. The NCBP was established by virtue of Presidential Executive Order No. 430 on 15 October 1990 with the principal responsibility of identifying and evaluating the potential hazards in genetic engineering experiments or in the introduction of genetically modified organisms into the country. It is likewise mandated to formulate and review national policies and guidelines on biosafety.

As early as 1990, coordination mechanism is in place among the agencies involved in biosafety regulation because of the membership of each from Departments of Science, Environment and Natural Resources, Health and Agriculture to the NCBP. Moreover, their membership in the Committee allowed them to build their capacity/capability in conducting risk assessment of GMOs and prepare them to handle the next level of risk assessment of GMOs. From 1990 to 2002, the NCBP handled all applications for contained use and field tests of GMOs until the issuance of the Department of Agriculture (DA) in April 2002 of Administrative Order No. 8 (DA AO8) spelling out the rules and procedures for the importation and release into the Environment of plants and plant products derived from the use of Modern Biotechnology, when the responsibilities of evaluation applications for field tests, propagation and importation of GMOs for direct use as food, feed or for processing were transferred and handled by the DA.

Meantime, assessment and approval of proposals for contained use (laboratory/greenhouse) and confined test remained under the NCBP.

On March 17, 2006, Executive Order No. 514 was issued, Establishing the National Biosafety Framework (NBF), Prescribing Guidelines For Its Implementation, Strengthening The National Committee on Biosafety of the Philippines (NCBP) And For Other Purposes. This issuance further strengthened the existing science-based determination of biosafety of GMOs, enhance the decision-making process to make it more efficient, predictable, effective, balanced culturally appropriate, transparent and participatory and serve as guidelines for implementing international obligations on biosafety. The framework also stipulated the principles and guidelines that should govern biosafety decisions, to wit: standard of precaution; risk assessment; role of environmental impact assessment; socio-economic, ethical, cultural and other considerations, decisions under the Cartagena protocol on biosafety and monitoring and enforcement.

The NCBP leads the implementation of the NBF and spearheads the coordination and harmonization of inter-agency and multi-sectoral efforts to develop biosafety policies in the country, and set scientific, technical and procedural standards on action by agencies to promote biosafety in the country.

Other Departments of the government participates in the decision making process as appropriate: Department of Foreign Affairs (DFA) in promoting and protecting Philippine interests on biosafety in bilateral, regional and multilateral forums;  Trade and Industry in relation to biosafety decisions which have an impact on trade, intellectual property rights, investments and consumer welfare and protection; National Commission on Indigenous Peoples in relation to biosafety decisions which have a specific impact on indigenous peoples and communities; and the Interior and Local Government in relation to biosafety decisions which have an impact on the autonomy of local government units.

The NBF recognizes the importance of transparency and availability to the pubic and relevant stakeholders of information related to biosafety decisions. A such, the concerned departments, subject to reasonable limitations to protect confidential information, disclose information on such application. Another platform for engaging the public and exchanging  information on the action by relevant departments are the Biosafety Clearing House- Pilipinas which was established in 2008 and maintained by the Secretariat of the Department of Science and Technology Biosafety Committee (DOST-BC), the websites of the DOST-BC and the NCBP. Public information and education on biosafety and biotechnology are continuously conducted not only by the regulatory agencies but other sectors as well to provide the public and other stakeholders accurate information on biosafety of GMOs and the utility of the products of modern biotechnology.


Challenges to ensure proper implementation of the NBF: There is a need to strengthen the capacities of the various sectors engaged in biosafety regulation, hence the design, adoption and implementation of a capacity building program supported by adequate financial resources should continuously be pursued. There is need to review periodically the NBF to identify the gaps and lessons learned from its implementation and incorporate new information that may lead to its improvement. Budget and institutionalization  of biosafety in the respective departments remains to be a major problem. Yearly allocation of resource   for the operations of the Department Biosafety Committees and provision of permanent administrative staff to support the NCBP are not provided, hence activities are funded and became rider activities in a bigger program. Lastly, given the fast pace of developments on the field of modern biotechnology and in anticipation of the new wave of products, the department biosafety committees should have a full complement of full time scientists and non-scientists staff, which up to this time are all part-timers and the regulatory work is an added responsibility of regular personnel to on top of their regular work load.

I believe that budget and manpower remains the perennial problem in implementing biosafety system not only in my country but in other economies/parties as well. Despite these hurdles, we should continue to do our share in providing accurate information not only to the public but most especially to our legislators who decides when and if biosafety regulatory programs will be given adequate funds. Coordination among those involved in biosafety regulation remains to be a one of the challenges in ensuring an efficient and predictable regulatory system. 

I thank you all for your contributions to this forum which I find educational and informative.
posted on 2015-05-06 03:56 UTC by Ms. Julieta Fe L. Estacio, Philippines
This is a reply to 7042 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7051]
Dear All,

I agree with the German representative’s answer regarding its statement saying that in the European Union, risk assessments for LMO field trials, LMO cultivation and LMO intended for direct use as food, feed, or for processing (FFP) are handled in a transparent and participative process based on established EU legal frameworks.

As regards the regulatory biosafety framework in Spain, and under the scope of our national legislation, there are two main referee Bodies at national level for assessing and authorizing experimental activities carried out with LMO/GMOs and for the commercialization of GM products.

The National Commission on Biosafety (CNB), a scientific body composed by representatives of various Ministries, Regional Competent Authorities and scientific experts, which is responsible for the scientific assessment for all LMO/GMOs, with the main objective of advising the Spanish Competent Authorities (Regional or  National Authority) on all the aspects relating to GMOs.
The Inter-ministerial Council of GMOs (CIOMG) holds the function of coordination among all ministries (Agriculture, Food and Environment, Health, Science, Education, Domestic Affairs, etc.) and regional Competent Authorities, and is the National Competent Authority responsible for granting the permits for experimental trials and for coordinating the Spanish vote for the authorization of all GM products at EU level.
CNB and CIOMG are both focal points for the Cartagena Protocol. The CIOMG is in charge of maintaining current Spanish entries in the BCH, except for GM products authorized by EU, which is the European Commission the responsible, as well as for updating the OECD Biotrack.

In this regard, we consider that we have national formal mechanisms (CNB and CIOMG) which facilitate intersectoral dialogue among the ministries and stakeholders involve in these issues.
We could still enhance the internal coordination, under these two bodies, with the agencies involved in the FAO GM Food Platform, in which we have less experience.
Furthermore, in Spain there is an official webpage with all relevant information on activities with GMOs.
http://www.magrama.gob.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/

With regards to the work of FAO/CBD/OECD, efficient coordination and communication would be desirable in order to achieve interoperability among the different databases. Although we realize that each database operates independently under a specific mandate and own resources, it would be very useful to streamline and harmonize as far as possible data requirements in their respective databases.

Lucia Roda
National Commission on Biosafety (CNB)
Spain
posted on 2015-05-06 09:37 UTC by Dr. LUCIA RODA, MINISTERIO DE AGRICULTURA, ALIMENTACIÓN Y MEDIO AMBIENTE
This is a reply to 7051 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7064]
Dear all,

I am Ward Hermans and I am working with Masami Takeuchi at FAO. Many thanks for the very interesting reactions posted so-far.  In addition to the comments made above, I would be specifically interested in learning more about how agencies involved in GM food safety assessment coordinate with agencies responsible for environmental risk assessment. How is this achieved on the practical level? What challenges exist?

Furthermore, I would like to flag that the registrations for the webinar of 27 May 2015 are opened now.   More information can be found on: http://www.fao.org/food/food-safety-quality/a-z-index/biotechnology/biosafety-events/en/

Kind regards,
Ward
posted on 2015-05-06 16:32 UTC by Ward Hermans, FAO - The Food and Agricultural Organization
This is a reply to 7064 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7084]
Dear all, thank you for the wonderful responses.
Please find below response from Uganda.

1.what worked well in terms of inter-agency coordination and communication  and what did not?

Participation in meetings, workshops, and training opportunities worked well. Advocacy and public awareness creations especially in the media did not work well. Seems many agencies do not want to be seen as promoters but at least if they tailored their messages on the particular roles eg regulation, teaching etc. that would be fine and very helpful.


2 What formal mechanisms/structures are put in place in your country to promote inter-agency coordination and communication? How about informal mechanisms?

The Uganda Bio-safety and Biotechnology Consortium (UBBC) is a formal mechanism. It has membership from all the agencies and aims to create awareness of biotechnology the bio-safety issues but most importantly provide information to the policy makers whenever they need it to understand the topic. Another is a project, the Uganda Bio-science Information Centre, based at one of the National Agricultural Research Organisation institutes, National Crop Resources Research Institute. It brings together various agencies to communicate, research, education and regulation.

3  How do you think international organizations such as FAO/CBD/OECD can help you in improving the national coordination mechanism in your country?

Provide some assistance and capacity building in communication, and funding a coordination mechanism, such as regular meetings and workshops for in country agencies. Especially health and environmental officials require much more awareness and developing communication strategies and tools for their respective agencies.

4 How food safety/health officials and environment/biosafety officials are communicating (well) at the national level in terms of biotechnology and GMO related work/activities.

NO; seems like the processes leading to the bio-safety an biotechnology bill did not have many such officers and leaders of those agencies. Sometimes their roles are poorly understood.

5.  Also what challenges are you facing in terms of coordination?

Lacks of awareness of roles; specific agencies roles are still not yet statutory and therefore not recognized or even funded

6. How agencies involved in GM food safety assessment coordinate with agencies responsible for environmental risk assessment.
Currently there is no coordination between the two organizations since guidelines are not yet developed to describe coordination mechanism.
posted on 2015-05-07 08:29 UTC by Mrs. Moreen wejuli, Uganda National Bureau of Standards
This is a reply to 7084 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7085]
Anent to my earlier contribution to this forum, I would like to submit for purposes of clarification that the Philippines  biosafety regulations are governed by two Presidential issuances: E.O. 430 (1990) and 514 and E.O 514 (2006)

The NCBP per E.O. 430 (1990) was an inter-agency, scientific and technical body consisting of scientists and ex-officio members of the Departments of Agriculture, Environment and Natural Resources, Science and Health whose work was to evaluate and identify potential risks  involved in genetic engineering experiments under contained use.

Under E.O. 514 issued in 2006, the new NCBP was created to serve as a policy coordinating body with expanded membership to include other relevant government departments, scientists, community, industry and consumer representatives.

Contained use and confined tests became the responsibility of the Department of Science and Technology Biosafety Committee, members of which includes representatives from the regulatory agencies.  The Department of Agriculture takes charge of risk assessment and monitoring of plant and Plant products; Department Environment and Natural Resources for bioremediation agents, improvement of forest genetic resources and wildlife genetic resources and the Department of Health for processed food derived from or containing GMOs.

Thank you.
posted on 2015-05-07 09:22 UTC by Ms. Julieta Fe L. Estacio, Philippines
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7088]
Dear all,

As was mentioned already (by German and Spain representatives) in European Union (EU) risk/safety assessment of genetically modified organisms (GMOs) for field trials, cultivation and GMOs for direct use as food, feed, or for processing (FFPs) are handled in a transparent and participative manner based on established legal system.

With regard to the biosafety system in Slovenia it embraces fully functional regulatory framework, legislative as well as administrative, including key elements of EU and international legislation (CPB) with environmental risk assessment (ERA) as its main objective. In Slovenia, the horizontal Management of GMOs Act adapted in 2002, amended in 2004 and 2010 provides a horizontal type of legislation on the use of GMOs and their products, and intermediate other existing legislation in the areas of agriculture and health care. It defines competent authorities (Ministry of the Environment and Spatial Planning, Ministry of Agriculture, Forestry and Food, Administration of the Republic of Slovenia for Food Safety, Veterinary Sector and Plant Protection and Ministry for Health) that have responsibilities in the field of GMOs, depending on the subject and intended use of the GMOs. Notwithstanding, risk/safety assessment for the environment and human health is the key element in all decisions on GMOs, irrespective of the authority responsible for the decision.

To that respect on the national level the two Scientific Committees were established to provide independent scientific advice on ERAs on GMO on the expert level in the field of the work with GMOs in contained use and the deliberate release of GMOs into the environment and placing products on the market, respectively. Further, the Commission for GMO management was also set up with the aim of monitoring conditions and developments in the area of GMO management.

The Government Functioning Act is the basis for coordination among the responsible ministries and administration. The main challenge in the coordination is timely response where the human resources scarce. However there is still room of manoeuvre to enhance the internal coordination, collaboration and communication.

However, for the time being, taking in regard over a decade of experiences, we believe that Biosafety system in Slovenia based on awareness and collaboration of all key stakeholders, assures adequate Biosafety.

With regards to the work of FAO/CBD/OECD, we are supportive with those who favour efficient and effective coordination and communication among them in order to achieve interoperability of different databases.

Best regards,
Martin Batic
NFP CPB/Slovenia
posted on 2015-05-07 12:47 UTC by Mr. Martin Batič, Slovenia
This is a reply to 7064 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7091]
To answer the question by Ward Hermans "How agencies involved in GM food safety assessment coordinate with agencies responsible for environmental risk assessment. How is this achieved on the practical level? What challenges exist?"
As indicated in my first post #7014, in Belgium the risk assessment of any activities involving GMOs is performed by a single advisory system. That means that food safety and environmental safety are assessed by the same entity in a harmonized way according to the same methodology and principles.
posted on 2015-05-07 14:31 UTC by Mr. Didier Breyer, Belgium
This is a reply to 6799 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7097]
Dear all forum participants,

In reference to the inter-agency coordination, one of the main actions in the order of the national coordination is the development of capabilities, particularly in the development of human resources through training and technical updating, this capacitation must be offered to teaching and research institutions and national authorities in the sectors of interest.

In this sense, Mexico, through their focal point the Inter-Secretarial Commission on Biosafety of Genetically Modified Organisms (CIBIOGEM) and in coordination with differents national authorities aimed to the operation and implementation of mechanisms for training and development of human resources, such as the broadcast of seminars and online courses (offered in spanish to officials and people interested) in issues concerning to biotechnology and biosafety and in the conformation of specialized working groups concerning issues such as synthetic biology, GMO low levels presence and so forth.

The focal point (CIBIOGEM) and the competent Mexican government agencies, coordinates the design, organization and evaluation of each training mechanics, using a webpage that provide information and study materials for participants and the society.

Therefore, it is considered important for the strengthening of the inter-agencies coordination, create a focal point for connection that will serve to transfer the decisions of international organizations such as FAO, CODEX, CBD and OECD and the opinions from differents experts to government agencies and competent authorities.

Best regards,

Rafael Romero
Biosafety Direction for Genetically Modified Organism
Mexican Agroalimentary Health, Safety and Quality Service (SENASICA)
posted on 2015-05-07 23:00 UTC by Mr. Rafael Romero, Mexico
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7100]
Dear Forum Participants;
I would like to thank FAO/CBD/OECD for such an opportunity and a significant event.
Issues related to Biosafety in Turkey are addressed in accordance with the Biosafety Law that has been in effect since 2010 along with two regulations under the law.
          Biosafety Law; contains the provisions regarding research, development, processing, place on the market, monitoring, using, importation, exportation, handling, transportation, packaging, labelling, storage and similar operations in relation to genetically modified organisms and its products.
         According to Biosafety Law it is forbidden to cultivate GM crops and raise animals in Turkey. Addition, it is also forbidden to be included in baby foods.
         Biosafety Board founded in 2010 to evaluate applications about GMO and products and perform tasks that are written in Biosafety Law and related regulations. The Board consists of nine members from different ministries including Ministry of Food, Agriculture and Livestock (MFAL) which is the Focal point for the CPB and clearing-house mechanism, Ministry of Environment and Urbanization, Ministry of Forest and Water Affairs, Ministry of Health, Ministry of Science, Industry and Technology and Ministry of Economy. MFAL has four seats (two from MFAL, one from university, one from NGO)  and other ministiries have one member each.
Risk assessment and  a socio-economic assessment committees are established by the Board for evaluation of applications related to GMOs and in order to make scientific assessments. 
Biosafety Board makes a “Decision” about applications on GMO and products, taking into account Scientific Committees’ risk assessment and socio-economic assessment.
The inter-agency coordination and communication is currently sufficient. However, it needs to be developed and strengthened. FAO/CBD/OECD could provide a technical assistance for improving national coordination mechanisms such as trainings, regional workshops, video, online conferences (video conferences and tele conferences or online forums), webinar.
Ali Osman Sarı, Ph.D., Turkey
posted on 2015-05-08 09:12 UTC by Dr. Ali Osman Sari, Turkey
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7106]
POSTED ON BEHALF OF AMPARO C. AMPIL
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Dear Forum participants:

Thank you for sharing your experiences: I just would like to add to what my colleague from Philippines, Ms. Baby Estacio of the National Committee on the Biosafety of the Philippines (NCBP) has already said.

In addition to its current mandate to assist regulatory agencies in their biosafety policy such as risk assessment and management, the NCBP serves as a forum of exchange of experiences in policy and regulatory issues. The member-agencies of the NCBP regulate in accordance with their mandates. For examples in connection with plants derived from modern biotechnology,  the Department of Science and Technology supervises  contained use and confined  trials, the Department of Agriculture regulates  field tests and propagation.

The Department of Agriculture (DA) has its internal mechanism for regulation. Under the DA, The Bureau of Plant Industry is the single entry point of applications in the case of GM plants and is responsible for environmental risk assessment; the Bureau of Animal Industry of feed safety, the Bureau of Agriculture and Fisheries Standards for food safety, the Fertilizer and Pesticide Agency for registration of Pest-Protected Plants. the risk assessment conducted by these agencies are assisted by Scientific and Technical Review experts, for each areas. This mechanism is accompanied by coordination of agencies within the Department as the BPI is the entity that issues the permit.  In addition, the Department of Agriculture Office of the Undersecretary for Policy and Planning provides oversight to any policy or regulatory issue or any potential conflict, to these regulatory agencies.

Relevant OECD consensus documents provide the considerations or the list of requirements that are needed in risk assessment. Usually the DA and its agencies sit down to consider all these requirements or anticipate the issues at an early stage, such as when we are aware that there is already an application for contained use. Consensus documents are also relevant to the work of other regulatory agencies and the NCBP.

Amparo C. Ampil
Department of Agriculture Philippines
posted on 2015-05-08 15:48 UTC by Dina Abdelhakim, SCBD
This is a reply to 7064 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7107]
POSTED ON BEHALF OF OSSAMA EL-TAYEB
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In the proposed Egyptian law, applications are examined by a committee of 9 representatives of specific relevant organizations + 9 experts in personal capacity nominated by relevant organizations and approved by the Prime Minister + a chair with no voting right appointed by the ministry of environment.  The composition of the committee is relegated to (and appointed by) the Prime Minister  in consultation with the relevant ministries and is appointed for a 4-year term (except for representatives of ministries who would serve as long as their nominating ministries continue to uphold their appointment).  Decisions are taken by two thirds majority of members attending the meeting and are issued in the name of the Prime Minister.  Decisions are appealed in the first instance by the committee and can further be appealed by the courts.  The structure attempts to make the decisions attributed to all relevant offices and eliminates possible "concentration of power" in any given ministry.  The committee may refer specific applications to other relevant bodies not represented (including socioeconomic, cultural and religious authorities and even "the public" and "time-freezes' while this is taking place.  I would appreciate any advice from Forum members on the system proposed.
Ossama El-Tayeb, NFP, Biosafety, Egypt.
posted on 2015-05-08 15:50 UTC by Dina Abdelhakim, SCBD
This is a reply to 7091 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7108]
POSTED ON BEHALF OF OSSAMA EL-TAYEB
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This is a wise and practical approach.  The proposed Egyptian law follows a somewhat similar approach.
O.M. El-Tayeb, NFP- Egypt
posted on 2015-05-08 15:52 UTC by Dina Abdelhakim, SCBD
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7109]
Dear Forum Participants,
We would like to thank you for your enthusiastic participation in this forum.

The views shared during this discussion will make for a solid starting point for our upcoming FAO/CBD/OECD Webinars of International Databases on Biosafety, on Good practices for effective national communication mechanisms.

More information regarding the webinar, including how to register to participate, can be found at http://www.fao.org/food/food-safety-quality/a-z-index/biotechnology/biosafety-events/en/.

Finally please note that this forum is scheduled to close on the 10th May at 1 am GMT.  Participants are invited to make their final comments over the next two days.

Kindest regards,
Dina
posted on 2015-05-08 16:05 UTC by Dina Abdelhakim, SCBD
This is a reply to 7109 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7124]
Dear All

Thank you for  all your  sharing your experiences and knowledge and to the organizers of this forum. I just want to add to what my colleague Dr S.A. Neeliah stated before for Mauritius.

The Genetically Modified Organisms (GMO) Act of 2004 provides for measures to regulate the responsible planning, application, development, production, use and commercialization of GMOs. It became in force in January 2005 but few were proclaimed. The Ministry of Agro-Industry and Food Security is the responsible Ministry for the Act.

The GMO Act establishes the National Biosafety Committee (NBC) constituting of representatives of various Ministries and institutions, including the Ministry of  Environment, the Ministry of Health, the Ministry responsible for International trade, the Mauritius Sugar Industry Research Institute, the University of Mauritius, the Food and Agricultural Research Institute, Mauritius Research Council, a law officer designated by the Attorney-General and representative of consumer associations.

The NBC is the formal mechanism responsible to advise the Ministry of Agro-Industry & Food Security on all aspects pertaining to GMOs and to facilitate inter-agency communication and coordination  on biosafety related issues. However, at the time of proclamation of the few sections of the Act, there were no supporting regulations. Another committee under the UNEP/GEF project to establish a transparent biosafety framework for Mauritius was set up comprising of some members of the NBC to work on various guidelines and regulations. The NBC has been re-established since last year and working on revising the GMO Act and finalizing the regulations and other required guidelines and documents.

There is a proposal to set up a biosafety office that would support the NBC and to which the different focal points would be liaising on biosafety issues. This could establish an effective communication and coordination mechanism among the focal points, national contact points and competent authority. However, the recruitment of competent personnel to effectively and efficiently to act as an independent technical arm to the NBC would be required. Improvement in terms of risk assessment, public participation, training of personnel at different stages involved such as laboratory, border control, etc. would also be required.

So far, when the NBC was not functioning, inter agency communication was quite limited. Another rather informal mechanism was the sub committee on foods derived from biotechnology under the National Codex Committee and comprises limited stakeholders in the field of biotechnology. I feel that many other challenges in inter agency communication and coordination will emerge once the GMO Act is fully proclaimed. The sharing of experiences from other countries would be of utmost importance then.

I also agree to what many contributors have suggested on the support from international organisations:
1. To have a guidance document to effectively integrate biosafety into national policies.
2. To assist in the development of regional networking systems, trainings, workshops to share experiences.
3. To include all laboratories concerned with GMO testing for regulatory purposes in a lab harmonisation process.
4. To have the opportunity for exchange of information, experts’ views and guidance from one of the platforms.
Thanking you all again
Best regards
Sharmila Buldewo
Focal point GM Food Platform - Mauritius
posted on 2015-05-09 16:42 UTC by Mrs Sharmila Buldewo, Ministry of Agro-Industry & Food Security
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7126]
Dear all,

In Bhutan, through the UNEP-GEF National Biosafety Framework Project, The Ministry of Agriculture and Forests has drafted the Biosafety Bill of Bhutan to implement the provisions of the CPB in Bhutan. It has been endorsed by the Cabinet of Bhutan and is currently awaiting endorsement at Parliament. Earlier, we didn’t have a coordinated system for inter-departmental coordination, so through the Bill, we have proposed the establishment of a biosafety administrative system comprising of the National Biosafety Commission (NBSC), the Technical Working Group on Biosafety (TWG) and a national competent authority for biosafety related activities, BAFRA (Bhutan Agriculture and Food Regulatory Authority).

The NBSC is an inter-departmental decision making body to address the cross-cutting biosafety issues and the TWG is the technical advisory body to the National Competent Authority – BAFRA. In the absence of the Biosafety Bill, policies/notifications and other regulations are being implemented. Till date, the mechanisms used by BAFRA are usually mediated through official notifications, meetings and emails. For Bhutan, there are challenges in inter-agency communication as biosafety is a new concept, the regulations are under process, and due to limited local experts in this field.

Assistance from international organizations such as FAO/CBD/OECD for effective coordination and communication between these stakeholders and guidance through the implementation of regional projects, workshops and training would prove to be very beneficial.

Best regards,

Tashi Yangzom
Focal Point, FAO GM Foods Platform
Bhutan
(edited on 2015-05-09 17:47 UTC by Ms Tashi Yangzom)
posted on 2015-05-09 17:45 UTC by Ms Tashi Yangzom, Ministry of Agriculture and Forests
This is a reply to 7109 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7127]
Reply to #7064
In Ghana, risk assessment (to assess the potential adverse effects on human health, plant health, animal health and the environment) of all activities involving GMOs is conducted by the Technical Advisory Committee which is the national advisory body on matters involving genetically modified organisms and related matters. The membership of the TAC which is provided in the Ghana Biosafety Act 831, includes all the regulatory agencies who together carry out risk assessment and audit of applications at the request of the Board, the governing body of the National Biosafety Authority. The TAC submits a review report to the Board to take a decision.  As a single unit, the TAC facilitates communication among the regulatory agencies during the risk assessment process whilst the sharing of concerns and experiences, enhances timely completion and submission of the review report.
posted on 2015-05-09 20:17 UTC by Prof Josephine Nketsia-Tabiri
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7128]
.Reply to #7064
In Ghana, risk assessment (to assess the potential adverse effects on human health, plant health, animal health and the environment) of all activities involving GMOs is conducted by the Technical Advisory Committee which is the national advisory body on matters involving genetically modified organisms and related matters. The membership of the TAC which is provided in the Ghana Biosafety Act 831, includes all the regulatory agencies who together carry out risk assessment and audit of applications at the request of the Board, the governing body of the National Biosafety Authority. The TAC submits a review report to the Board to take a decision.  As a single unit, the TAC facilitates communication among the regulatory agencies during the risk assessment process whilst the sharing of concerns and experiences, enhances timely completion and submission of the review report.

Josephine Nketsia-Tabiri
Ghana NFP
FAO GM PLATFORM
posted on 2015-05-09 20:21 UTC by Prof Josephine Nketsia-Tabiri
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7153]
Dear all:
Greetings from Iran!
First of all, I wish to thank Masami, Ward, Manoela, Dina, Peter, Bertrand, Taka, the secretariat and the others who organized this forum. I have been reading with care all the contribution and wish to provide my input at the last moments before the forum is officially closed.  My name is Behzad Ghareyazie, President of the Biosafety Society of Iran and the CPB National Focal Point of the country.  I have been involved in CPB negotiations and related issues since 1999.
Though very similar to what my country mate Nasrin (Iran NFP for BCH) has contributed, I wish to also add that according to Iran’s National Biosafety law (accessible ta: BCH) a National Council of Biosafety (NCB) was established for policy making and decision making as well as inter-agency coordination and communication. This is a very high ranking council that is headed by the First Deputy President of the country. Minister of health, Minister of Agricultural Jihad, Minister of Science, Research and Technology as well as the head of the Environmental Protection Organization are the members. In addition to this representatives of the relevant Scientific Societies, a faculty member from medical field are also members of this council with the right to vote. Two Parliament members one from the Agriculture commission of the parliament and another one from the commission of Health also attend in NCB as observers. In this council different agencies/sectors speak out and communicate well. The decision is made by consensus and if necessary (in rare cases) by voting. In addition to this the secretariat of the council invites representatives of the members of the council for working out the draft decisions to be submitted to the council. This is where the real discussions occur. The members of these meetings are at the level of high ranking officials with real expertise and familiarities with the subject matter. This is a formal mechanism for the required coordination in Iran. This enables the coordinated attempt to mainstream biosafety into each sector’s policies and strategies.
There is also an informal mechanism practiced by the CPB National Focal Point (CPBNFP). CPBNFP has created a “Consultation council for CPBNFP”. This consultation council is composed of experts nominated by the members of NCB plus several experts and more representation from scientific societies and other stakeholders such as the Ministry of trade and Standard Organization.  All the activities and decisions executed by CPBNFP is decided in consultation in this meeting. Forced consensus mechanism has been successfully practiced in this consultation council and worked well.
International organizations such as FAO/CBD/OECD can help countries in improving the national coordination mechanism. The capacity building programs at both national and regional levels can be helpful. In particular, in the regional programs countries can learn from each other’s experiences, success stories as well as their bad experiences. This online forum and the follow up webinars as well as physical meetings can be of paramount importance in improving national coordination mechanisms.
Scientific societies and farmers union (farmers House) are also very strong players in biosafety. They play an informal but very strong, influential and effective role in biosafety particularly communicating with the public in one hand and the government officials in other hand.  Since these societies are composed of members coming from different sectors, this per se provides another informal forum for inter-organizational communication and coordination.
One of the challenges we are facing in Iran is the “horrification syndrome” imposed to the public by foreign-supported activists. Growing levels of technophobia is one of the results of this horrification activities based on ill-informed activists and environmentalists.
To reply to the question made by Ward, I wish to mention that this issue of coordination among agencies involved in GM food safety assessment with agencies responsible for environmental risk assessment is an immediate challenge. Environmental Protection Organization lacks the capacity for an conducting environmental risk assessment harmonized with the food safety assessment and agricultural practices.
posted on 2015-05-10 19:23 UTC by Mr. Behzad Ghareyazie, Iran (Islamic Republic of)
This is a reply to 6759 RE: Opening of Discussion: Challenges and experiences in establishing and maintaining inter-agency communication on biosafety-related issues [#7159]
Dear Forum Participants,

Korea’s system of LMO safety management is based on the Act on Living Modified Organisms that came into effect in 2008. A National Biosafety Committee was established as the highest consultative body for securing biosafety.  The role of seven government ministries has been broken down depending on the purpose of the LMO, to participate in safety management.  Among the ministries, the Ministry of Trade, Industry and Energy is the Competent National Authority that coordinates workflow and plays the role of representative in implementing the Protocol.

The role of each ministry in LMO safety management is divided as follows according to LMO type: the Ministry of Science, ICT and Future Planning treats LMOs for tests and research purposes; the Ministry of Agriculture, Food and Rural Affairs treats LMOs for agriculture and livestock production purposes; the Ministry of Trade, Industry and Energy treats LMOs for industry purposes;  the Ministry of Health and Welfare treats LMOs for health and medical purposes; the Ministry of Environment treats LMOs for environment and purification purposes; the Ministry of Oceans and Fisheries treats LMOs for maritime and fishery industry purposes; the Ministry of Food and Drug Safety treats LMOs for food and medical equipment purposes.  This system may be somewhat complex, but can be helpful in the conduct of national LMO safety management by each pertinent ministry with expertise.  In addition, it clarifies accountability regarding biosafety.

The core of Korea’s safety management system is consultation and review by each ministry upon LMO import, production, and usage.  According to the LMO Act, the ministry responsible for review is designated according to the purpose of the LMO.  However, consultation must be conducted with other ministries regarding related areas.  For example, a particular LMO can be used incidentally for other purposes than the originally determined purpose, and the relevant environmental scope can overlap or be connected.  In such a system of consultation-based review, communication among ministries is essential due to the complex nature of LMOs.

The Ministry of Trade, Industry and Energy plays the main role as the responsible entity in communication among ministries.  The Korea Biosafety Clearing House also plays an important working level role.  First, upon agreement between KBCH and the Ministry of Trade, Industry and Energy, a ministry meeting is held regularly once every two months, or when necessary.  KBCH not only provides domestic and foreign LMO-related information to related ministries, but assists in communication regarding major review issues or other LMO related topics of national interest.  To be more specific, each month KBCH collects, shares and discloses information regarding biosafety (hazard assessment, government decisions, LMO import volume, etc.).  It conducts working level preparations for consultative meetings among government ministries regarding hazard assessment on a regular basis.  In addition, each year, it conducts information sessions on the legal system and GMOs, as well as the LMO Forum, together with related ministries for the regular public. 

Moreover, demand for institutional improvements that results from inter-ministerial discussion and dialogue with the people can be reflected by revision of the LMO Act through consultation with ministries.  Every five years, the 7 ministries must establish a safety management plan according to the law, and prepare a detailed implementation plan for execution each year.  Establishment of plans and the results are revealed to the public by disclosure on each ministry’s webpage.
   
In conclusion, since 2008, the Republic of Korea has been operating a stable LMO safety management system based on two revisions of the LMO Act and accumulated experience.  Korea proposed the “Korea Biosafety Capacity Building Initiative” at the 7th Conference of the Parties held in Pyungchang, Korea.  By sharing its safety management experience with the Parties, and promoting sharing of experiences among the Parties, it aims to contribute in promoting the overall implementation level of the Biosafety Protocol.  In 2015, it conducted a four-day workshop for the Kingdom of Bhutan, which is in its final stages of building a national LMO safety management system.  The Republic of Korea hopes that it shall have the opportunity to provide such events and forums to other Parties.
posted on 2015-05-10 21:30 UTC by Mr. Ho-Min Jang, Republic of Korea