| PROCEEDINGS
THE REGIONAL CONSULTATION ON CAPACITY BUILDING
IN BIOSAFETY OF GM CROPS IN ASIA
Century Park Hotel, Bangkok Thailand
7–10 July 2003
DAY 1
I. Background and Rationale
1. Agriculture plays an important role in national economy
and development in Asia, where most of the population resides
in rural areas and depends on agriculture for subsistence.
While the region has experienced record gains in productivity
over the past three to four decades, a sustained increase
in farm productivity is vital for the region, particularly
with the limited availability of extra arable land. In this
respect, biotechnology presents considerable potential by
boosting outputs, reducing production costs, increasing nutritional
value and promoting the efficiency of agroprocessing. In the
meantime, as the impacts of biotechnology on human health
and the environment remain unknown, biosafety has become a
primary issue.
2. Although they have differing stages of biotechnology research
and development (R&D), all the countries in the region
are aware of the importance of capacity building to assess
and manage the risks and benefits associated with genetically
modified organisms (GMOs). With the support of the Government
of Japan, the Food and Agriculture Organization of the United
Nations (FAO) is implementing the project “Capacity
Building in Biosafety of GM Crops in Asia” (GCP/RAS/185/JPN);
this project assists Asian countries in their efforts to harness
the benefits of biotechnology in accordance with relevant
global agreements and ensures safety in the introduction and
use of genetically modified crops (GMCs), based on transparent
and scientifically based approaches.
3. With the aforementioned background as a rationale, the
Regional Consultation on Capacity Building in Biosafety of
GM Crops in Asia was held from 7 to 10 July, 2003 at the Century
Park Hotel, Bangkok, Thailand. The participants included delegates
from project-participating countries (Bangladesh, China, India,
Indonesia, Malaysia, Pakistan, the Philippines, Sri Lanka,
Thailand, and Viet Nam), Japan, UN agencies, the CGIAR and
other international research centres, non-governmental organizations
(NGOs) and the industry sector; resource persons and stakeholders
were also present.
4. The primary objectives of the Regional Consultation included:
(i) identification of strengths and weaknesses in national
capacities; (ii) prioritization of support needed to enhance
national capacities; (iii) development of a work plan on the
harmonization of biosafety methodologies; (iv) promotion of
collaboration to avoid duplication of efforts; (v) development
of a constitutional framework for the Asian Bionet; and (vi)
organization of the Steering Committee and the Technical Expert
Group meetings.
II. Opening Ceremony
Welcome Remarks
5. The participants were welcomed by FAO’s Assistant
Director-General and Regional Representative, Dr He Changchui.
Dr He Changchui stated that regardless of the United Nations
Millennium Development Goals, 500 million people in Asia remain
undernourished. Biotechnology presents considerable potential
for food production and poverty reduction. However, it also
provokes concerns related to health and environment risks,
ethics, equity (the question of access) and democracy in decision-making.
6. He pointed out that the Regional Consultation presents
an arena for concrete discussions on future visions for Asia
and ways to address common concerns. FAO findings have revealed
gaps in the exploration of biotechnology benefits as well
as differences in the degree of R&D among countries. In
this context, capacity building is critical. Recognizing the
need to establish mechanisms for assessing and managing the
potential environmental risks associated with GMCs under the
Cartagena Protocol on Biological Diversity, FAO, with funding
support from Japan and in partnership with the participating
countries, is implementing the project on “Capacity
Building in Biosafety of GM Crops in Asia”.
7. The Regional Consultation aims to identify country-specific
strengths and weaknesses relating to national capacities on
the biosafety of GMCs, as well as to address the prioritization
of the support needed to enhance biosafety capacities in the
participating countries. Dr He reiterated that FAO would continue
to work with partners to address issues relating to the use
of agricultural science to reduce hunger and poverty.
8. Dr He hoped the participants would have a fruitful meeting
and a pleasant stay in Bangkok.
Introduction
9. Dr Susumu Kawabe, Plant Biotechnology/Biosafety Specialist
(GCP/RAS/185/JPN), provided a brief overview of the project,
which is supported by Japan for three years (2002–2005).
He explained that the development of GMCs presents huge potentials
for food security, poverty alleviation and sustainable agriculture;
however due consideration has to be accorded to biosafety
needs and this is reflected in national legislation and regulations
concerning the harnessing of GMCs. Meanwhile the GMC issue
remains controversial, particularly in the face of increasing
cross-border movement.
10. The project addresses biosafety needs in accordance with
global agreement, in conjunction with the strengthening of
technical cooperation among Asian countries to ensure biosafety,
particularly with regard to environmental impacts. Efforts
to generate adequate scientific, legal and institutional controls
and to harmonize biosafety standards and regulations need
to be based on voluntary initiatives and collaboration among
participating countries, with assistance from FAO and other
international organizations.
11. He indicated that the project aims to strengthen capacities;
establish an effective Asian Bionet; contribute to the harmonized
implementation of standards, guidelines, measures and methodologies
for risk assessment and management; and promote research and
technology development. Such objectives are to be achieved
inter alia through a wide range of activities such as regional
and national workshops, training manual preparation and the
establishment of Internet-based national and regional information-sharing
mechanisms.
12. He stressed that the Regional Consultation, the Steering
Committee and the Technical Expert Group meetings would facilitate
the identification of strengths and weaknesses of national
capacities; decision-making on priorities in capacity building;
the promotion of harmonization of methodologies, standard
and regulations; and the formulation of specific work plans.
III. Election of Chairperson and Rapporteur
13. Dr M. Nurul Alam from the Ministry of Agriculture of Bangladesh
was designated Chairperson and Ms Rhoda Grace As. Pituan from
the Bureau of Plant Industry of the Philippines as Rapporteur.
Ms Asna Booty binti Othman from the Department of Agriculture
of Malaysia was designated Co-chairperson.
IV. Plenary I
Keynote Address: Biosafety of GM Crops in Asia —
Opportunities and Challenges
14. Dr Eric Schoonejans, Biotechnologist, Ministry of Ecology
and Sustainable Development, France, explained that we are
in the early dawn of major technological changes facing agriculture
and food, including extremely powerful new GM biotechnologies.
This needs to be accompanied by appropriate biosafety frameworks.
When appropriately integrated with other technologies for
the production of food, agricultural products and services,
biotechnology can be of significant assistance in meeting
the needs of an expanding and increasingly urbanized population
during the new millennium.
15. Biosafety refers to ensuring the sustainable and safe
use of biotechnology, in accordance with international obligations
and addressing common policy. It improves the acceptability
of innovations and provides improved legal and trade conditions.
A biosafety framework for GMCs signifies a system of legal,
administrative mechanisms set in place to address environmental
and human health safety in the field of modern technology.
It sometimes covers issues of cost/benefit analysis, economic
or social impacts. It is a controversial subject because of
growing mutual distrust between the public and “technicians”,
which is attributable to insufficient communication of their
respective perceptions and needs.
16. The biosafety framework for GMCs should be a regulatory
framework; an administrative system; a decision-making process
encompassing risk assessment and management; as well as a
means for public information and participation. Preferably,
the biosafety framework will be country-driven and harmonized
globally. Concomitantly, the framework:
- facilitates the efficient use of regional and sub-regional
capacities, resources and infrastructures;
- is complete, specific and comprehensive;
- is based essentially on the risk analysis paradigm;
- is transparent, proportionate, effective and binding;
- is the complex articulation between instruments.
17. Capacity building for biosafety needs to be accompanied
by continuous R&D on biotechnology, with national or regional
efforts geared towards the required (and skilled) human resources.
It is important that capacity building is undertaken in such
a way as to (i) build upon existing capacities and initiatives;
(ii) cater to specific needs; and (iii) promote linkages with
other ongoing initiatives rather than duplicating them.
International Trends in GM Crop R &D and FAO Initiatives
on their Biosafety
18. Dr Andrea Sonino, Senior Agricultural Research Officer,
Secretariat of the Commission on Genetic Resources for Food
and Agriculture, FAO headquarters, reiterated the potentials
of biotechnology. If integrated properly with other technologies,
it can address food security and other key agricultural challenges
in developing countries. It needs to be accompanied, however,
by systematic risk assessment and management. In this connection,
he introduced FAOBioDeC, which is a database on the status
of the development, adoption and application of biotechnologies
in developing countries.
19. The geographical distribution of biotechnology application
is largely uneven, and concentrated in North and South America.
Biotechnology application in developing countries remains
mostly at the research level, with limited commercialization
and limited field testing. The commercial release of GMOs
has been undertaken in a few developing countries for a few
traits, focusing mainly on commodities. Therefore its contribution
to food security remains insignificant. GMO research in developing
countries focuses largely on crops and traits relevant for
food security.
20. The “monocular divide” (exclusion of vast
areas by biotechnology application) is attracting increasing
attention, while important problems are addressed insufficiently
or neglected completely. The impact on the biodiversity of
tropical ecosystems, for example, is virtually unknown. At
the same time, an effective biosafety framework is missing
in many countries.
21. FAO is aware of this situation and carries out a wide
range of activities to promote biosafety. These activities
include the provision of a neutral forum to develop international
instruments of governance; the provision of policy advice;
the ensuring of access to neutral and balanced information;
and the provision of technical assistance.
NGO/Private Group Initiatives on Biosafety of GM Crops
22. Dr George Fuller, Executive Director, Crop Life Asia,
introduced his organization, which represents the plant science
industry in Asia. This industry invents, develops, manufactures
and sells products and services designed to improve the global
production of food, feed, fibre and other products in a sustainable
way. The industry employs biotechnology, chemistry, plant
breeding and other techniques taking into account ethics and
standards as well as impacts on human health and the environment.
The industry addresses the concerns of all stakeholders in
a transparent manner.
23. Crop Life Asia is a regional network of 14 national crop
protection associations and six multinational R&D corporations;
priorities are stewardship, regulations, business and societal
issues, and communication and industry concerns. Its key activities
include regulatory affairs for agrochemicals; advocacy/acceptance;
science-based regulations for biotechnology; communications
through magazines, its Web site, its newsletter and special
publications; as well as e-learning via the Asia-Pacific Regional
Training Centre. The Internet-based distance learning courses
on the safe and responsible use of integrated pest management
(IPM), digital literacy and resource management have proved
to be an effective conduit for capacity building.
24. Crop Life Asia recently published its Reference guide:
biosafety frameworks addressing the release of plant LMOs
(living modified organisms) to (i) contribute to internationally
harmonized objective and science-based national biosafety
regulatory frameworks; and (ii) develop national capabilities
in implementing regulatory frameworks transparently, thus
ensuring safety while providing predictability to the proponents.
25. Primarily, the Reference Guide is designed to serve decision-makers
in the formulation and updating of their biosafety regulatory
frameworks. The Reference Guide was prepared as an important
input to national capacity-building programmes. It is organized
in such a way that discrete parts can be incorporated into
national regimes, and includes citations to relevant existing
authorities.
V. Country Paper Presentations
Bangladesh
26. The Bangladeshi economy depends mainly on the agricultural
sector. About 55 percent of the country’s population
is engaged directly or indirectly in agriculture. Despite
progress during the past 30 years, which has led to a 150
percent increase in food production, food insecurity remains
one of the critical concerns. Since current technologies are
insufficient to meet the future challenges of agricultural
production, it is envisioned that the introduction of modern
biotechnologies will contribute to food security and national
food sufficiency.
27. In 1999 the government formulated and approved biosafety
guidelines for conducting biological research and testing
of GMCs. The guidelines facilitated the creation of national
and institutional biosafety committees responsible for the
identification, assessment and evaluation of the potential
risks of GMOs; as well as a recommendation for measures to
minimize risk and to review or amend national policies and
guidelines on biosafety. Enforcement of the biosafety guidelines,
however, is still pending.
28. Biotechnology R&D is at an embryonic stage in Bangladesh.
Its activities focus only on the development, standardization
and use of in vitro culture and micro propagation. One particular
problem for the government in its R&D activities is the
lack of laboratory facilities and highly trained human resources
to conduct biotechnology research such as gene mapping. There
is also a need to create opportunities for strengthening the
capacity of biosafety management and to learn from the experiences
of other countries.
China
29. While research on agricultural engineering in China has
been relatively late in arriving, the Chinese government places
importance on biosafety. In the early 1990s the Ministry of
Agriculture (MOA) initiated an agricultural safety assessment
programme to regulate transgenic biosafety issues. To date,
the GMCs approved by the MOA fall into four categories, namely:
insect-resistant cotton, delayed ripening tomato, colour-altered
petunia and disease-resistant sweet pepper.
30. In 1993 the State Science and Technology Commission promulgated
the Safety Administration Regulation on Genetic Engineering,
which was the first law on biosafety. In 1996 the Office of
Genetic Engineering Safety Administration was founded to regulate
field tests, environmental releases and commercialization
of transgenic organisms. In 2001 the State Council issued
the Regulation on Biosafety Administration of Agricultural
GMOs, which was applicable to R&D on all GMOs. It stipulates
safety assessment systems concerning the assessment and approval
of all GMOs and their by-products. According to the Regulation,
the license is issued to any persons or organizations intending
to market GM materials, prior to commercial production. It
requires proper identification of all GMOs listed in the labelling
catalogue before entering the market, and demands that GMOs
destined for importation to China are subject to biosafety
administration.
31. Major challenges regarding biosafety issues include environmental
and biodiversity safety; human health concerns; food safety;
impacts on trade and economy; as well as societal and ethical
matters. Specifically, China faces challenges in terms of
insufficient scientific data on biosafety research; political
and trade-related concerns and pressures; incomplete nationwide
supervision and inspection systems; poor public acceptance;
the unclear long-term impacts of GMOs on the environment and
human health; and the need for the strengthening of capacity
building.
India
32. Being one of the leading countries that actively participated
in the formulation and negotiation of the Cartagena Protocol,
India acceded to the Biosafety Protocol in January 2003. The
country’s biodiversity is vast and it has a wide range
of agricultural products. India’s National Development
Plan identifies biosafety research and capacity building as
an important national priority. In the meantime, Bt-cotton
is the only transgenic crop approved for commercial cultivation.
33. India has a firm regulatory mechanism for the development
and evaluation of transgenic substances. Its legal framework
was established in 1989 whereas the recombinant DNA safety
guidelines were approved in 1990. The framework oversees the
development of GMOs from laboratory research to contained
use in open field trials and large-scale field testing before
release into the environment. The Government of India is following
a policy of case-by-case approval of transgenic crops. The
Department of Biotechnology under the Ministry of Science
and Technology is the main agency that supports research on
crop biotechnology.
34. India has expertise in the safe production, use and handling
of GMOs through its network of public and private sector institutions
and industries. However, the upgrading of institutional training
of human resources in advanced techniques, including analytical
detection methods and institutional strengthening is necessary
to enhance core competence in areas of environmental risk
assessment and food safety regulation.
Indonesia
35. The development of agricultural biotechnology began in
1983. The agricultural biotechnology programme focuses on
food production and import substitution, utilization of genetic
diversity, and development of bio-industry. The Agency for
Agricultural Research and Development (Ministry of Agriculture),
the Research and Development Centre of Biotechnology (Indonesian
Institute of Science), universities and the private sector
are developing transgenic food, horticultural, estate and
forest crops to improve resistance traits to biotic stresses,
quality and yield.
36. To accelerate the programme, the Government of Indonesia
has revitalized the National Research Council, which is responsible
for priority setting in biotechnology. A biosafety committee
was formed and is supported by a technical team, which has
formulated guidelines for the release of GMOs. Of the seven
transgenic crops that the committee has evaluated, only Bt-cotton
has been released into the environment. In order to encompass
public participation in decision-making for GMO release, the
Government of Indonesia is drafting a governmental regulation
on the safety of genetically engineered products. Under the
new regulation, the Committee for Safety of Biotechnology
Engineered Products provides assessment results for the public
via the official news network before making recommendations.
37. Capacity building of human resources with specific expertise
is a critical issue for Indonesia, partly since research and
risk issues and biosafety management of transgenic crops are
still at the initial stage and very limited. Additional support
for the capacity building of specialists in risk analysis
and public awareness is desired.
Malaysia
38. Malaysia has been a world leader in a number of plantation
crop industries. The government has stressed the need for
producing a sufficient amount of food for national security
and stability, and affords considerable support to biotechnology.
Biotechnology is earmarked as one of the areas of advancement
under the 8th Malaysian 5-Year Plan.
39. To accelerate biotechnology development, the National
Biotechnology Directorate was established, with the task of
spearheading and coordinating biotechnology research. The
Ministry of Science, Technology and the Environment is the
focal point; it has the responsibility of coordinating all
matters pertaining to biological diversity, including biosafety
under the Convention on Biological Diversity (CBD). The Genetic
Modification Advisory Committee (GMAC) was formed in 1996
to ensure that any risk associated with the use, handling
and transfer of GMOs is identified and managed safely; it
also advises the government about matters in genetic modification
technology and its application. Currently, GMOs are regulated
by GMAC-formulated guidelines, which have not passed into
law yet.
40. All research on GMOs is still at the experimental phase
under their confined use. With insufficient expertise on risk
assessment and the management of GMOs in the environment,
there is an urgent need for adequately trained human resources.
Infrastructure development is also critical to establish up-to-date
laboratories for monitoring and detecting imported GM plants,
plant products or food.
Pakistan
41. In Pakistan, crop improvement initiatives using modern
biotechnology started in 1985. Currently there are 26 biotechnology
centres/institutes, few of which have desirable physical facilities
and trained human resources to develop GMCs. Most of the activities
have been related to rice and cotton. Biotechnology is viewed
by many political leaders, policy-makers and leading scientists
as a priority. Pakistan is a member of the World Trade Organization
(WTO) and signatory to the CBD and the Cartagena Protocol.
42. Overall, the development of biosafety regulations has
been slow and largely incoherent. Despite local production
of transgenic plants, field evaluation is blocked due to the
absence of legislation related to biosafety. Although a draft
document was prepared in 1999 under the UNEP-GEF, The National
Biosafety Guidelines, Plant Breeders Rights Act 2002 and the
Geographical Indication for Goods remain subject to discussion,
evaluation and analysis. Meanwhile, an illegal GMC (cotton)
has manifested itself in farmers’ fields.
43. Coordinated efforts are needed among various ministries
to implement regulations and capacity building for import/export
and local handing of GMCs. There is an urgent need to organize
training workshops for policy-makers, legislators and lawyers
regarding the WTO, CBD and the Cartagena Protocol. Further,
Pakistan would benefit from the experiences of Asian countries
that have similar situations. While the development of GMCs
is almost a routine activity particularly for cotton, rice,
potato and tomato, there is a need to conduct research in
the areas of functional genomes, chloroplast transformation
and biofarming.
The Philippines
44. The Philippines realizes the importance of using new
technologies to attain a sustainable increase in farm productivity.
The overarching policy on GMOs is to support the application
of scientific information and the development of new technologies
that hasten agricultural development. The Department of Agriculture
undertakes a national biotechnology programme that ensures
the formulation, advocacy and implementation of biotechnology
policies, which deal with policy formulation and advocacy;
capacity building for regulation and technology development;
and education and information.
45. Biotechnology-related activities are regulated by the
National Committee on Biosafety (created in 1996), which formulates
and oversees the implementation of guidelines, policies and
capacity building; and the Department of Agriculture Administration
Order No. 8, which covers GMO safety for human health and
the environment in connection with the import and direct use
of food and feed, field trials and the propagation of GM plants.
Its principles include service-oriented and transparent risk
assessment; this is carried out by the Bureau of Plant Industry,
the Bureau of Agriculture and Fisheries Product Standards,
the Fertilizer and Pesticide Authority and the Bureau of Animal
Industry.
46. The Philippine capacity building programme encompasses
training on risk assessment and compliance monitoring; harmonization
of policies, standards and procedures; forging of partnerships
with industry stakeholders for technology transfer and development;
and the development of biosafety guidelines for GM animals,
aquaculture and pharmaceuticals.
Sri Lanka
47. Agriculture constitutes 19 percent of the GDP in Sri
Lanka. The country realizes that agricultural biotechnology
would significantly contribute to productivity and an increase
in food production. However, the potential of GMOs to achieve
this end has not been accepted fully yet. While the country
has been developing and applying biotechnology in some areas
since the mid-1970s, advanced biotechnology remains in its
infancy.
48. The Government of Sri Lanka is engaged actively in preparing
a national biosafety framework (NBF) in accordance with the
Cartagena Protocol. The Ministry of Environment and Natural
Resources implements the Protocol. Currently there are no
laws to deal specifically with GMOs. However, some provisions
in existing laws could be applied to control, check and even
to ban the introduction of certain GMOs to the country. These
could be used as a basis in formulating the national biosafety
regulations.
49. As a CBD signatory, Sri Lanka is obliged to develop national
guidelines and regulations for safety that are applicable
to all aspects of GMOs and their products. Critical issues
in this sense include the necessity for regulatory systems;
development of institutional capacity for risk assessment;
development of human resources; and infrastructure concerning
the benefits and risks of GMOs. More specifically, the priority
subjects for training and research are R&D; information
exchange; fellowship/postgraduate and short-term training;
and other areas such as intellectual property rights, industrial
activities and links with the private sector.
Thailand
50. Thailand appreciates the importance of modern biotechnology
and genetic engineering for national development. Nevertheless,
it has not yet ratified the CBD, thus making the country ineligible
to sign the Cartagena Protocol. In the meantime, with liberal
policies on R&D for gene technology, the government fully
supports development and capacity building in research and
production for modern biotechnology. The commercial release
of genetically modified plants, however, is not allowed until
they are proven “safe”.
51. Since the establishment of the National Center for Genetic
Engineering and Biotechnology (Biotec) in 1983 under the National
Science and Technology Development Agency, biosafety has been
identified as a national priority. An ad hoc Biosafety Sub-committee
was established under Biotec in 1992 with the main responsibility
of drafting biosafety guidelines in genetic engineering for
laboratory work, fieldwork and releases. The Biosafety Guidelines
on Genetic Engineering and Biotechnology for Laboratory Work
and for Field Work and for Planned Release were finalized
in 1992, and followed by the foundation of the National Biosafety
Committee and a number of institutional biosafety committees
in 1993 and thereafter. The Committee covers policy, institutional
and technical guidelines.
52. Challenges related to biosafety for Thailand include
a variety of constraints and limitations in terms of financial
and human resources. In particular, non-ratification of the
CBD poses a number of limitations.
Viet Nam
53. Viet Nam is an agriculturally oriented country with approximately
71 percent of the population residing in rural areas. To guarantee
food security and sustainable agricultural development in
parallel with social-economic renovation, the Vietnamese government
pays close attention to R&D for biotechnology. Local transgenic
plants are produced by research institutions and kept in laboratories
or greenhouses. No local GMCs have been released into the
environment. The most important transgenic plants that have
been developed are rice, maize, flowers, tubers and forest
plants. There is limited public awareness on and interest
in GMOs, and public reaction to GMOs is mixed.
54. Currently there are no biosafety guidelines in Viet Nam.
In 1999 the government established a working group to draw
up biosafety regulations. However, the government has not
approved any of the several drafts of biosafety regulations
that have been drawn up so far. The Vietnamese delegate emphasized
that the Decree on Biosafety Regulations for GMOs and Their
Products (the latest draft of 2003), was open to suggestions
and comments from all of the participants at the Regional
Consultation.
55. Viet Nam has a number of training and capacity building
needs to address.
Japan
56. In Japan, many R&D activities are being conducted
to utilize modern biotechnology in plant breeding. While it
is prohibited to sell and import GMOs that have not been declared
safe for human consumption, there is currently no commercial
cultivation of GMCs.
57. The Ministry of Agriculture, Forestry and Fisheries (MAFF)
established guidelines in 1989 to ensure the environmental
safety of GMOs. The guidelines will be replaced by new legally
binding regulations to implement the Cartagena Protocol. MAFF
is also responsible for evaluation and approval and established
another guideline in 1996 for the evaluation and approval
of feed safety; this was converted to legally binding regulations
in 2003. The guidelines concerning a safety assessment system
for GMO food application under the former Ministry of Health
(current Ministry of Health, Labour and Welfare) were converted
into a legally binding regulation in April 2001.
58. It is assumed that there is an increase of food and feed
(potentially) containing GMOs into the Japanese market, which
is proportionate to the expanded production of GMCs in major
exporting countries. Japanese consumers are very concerned
about the safety of GM foods (GMFs). Recent incidents regarding
unapproved GM varieties have raised further confusion and
worries among the public. The food industry has been subject
to negative consumer reactions since the middle of 1999.
Synthesis of the General Discussion
59. In response to an inquiry from the AVRDC representative
concerning the way in which China deals with illegal biosafety
procedures, Chinese representatives explained that since biosafety
regulation in China is a recent development, it is uncertain
whether any violations have occurred. However, Chinese regulations
are very strict. AVRDC representatives, referring to a case
in the Japanese “checking system” where consumers’
negative reactions to illegal products led to distrust of
the manufacturing company and possible loss in GMO sales,
highlighted the importance of the effective implementation
of established laws.
60. The ICRISAT representative pointed out that revising
nomenclature such as “biosafety” and “risk
assessment” may contribute to changes in public reactions.
Another issue raised was the need for careful consideration
when establishing a multilateral biosafety regulatory body
in a country that is unable to manage biosafety on its own.
Further attention should be paid to the benefits of biotechnology
for farmers and the environment. In this context, the Indian
representative responded to a question from the Vietnamese
national project coordinator that public consultation in India,
while still informal, increasingly includes NGOs, farmers
and other stakeholders. Companies are invited to make presentations,
and the government is requested to release further information
on its Web site.
61. The delegate from FAO’s headquarters recaptured
a point raised by Viet Nam that there is currently no clear-cut
distinction between legality and illegality related to biosafety.
He stressed the importance of regulations. Information is
critical, particularly transparency and communication with
the public. The need to narrow the “monocular divide”
was also reiterated, while still allowing all countries the
freedom to decide whether to accept importation of GMOs.
62. Day 1 concluded with a vote of thanks by the Co-chairperson
and the Plant Biotechnology/Biosafety Specialist.
DAY 2
VI. Summary of Country Presentations
63. The Chairperson and the Rapporteur reported on the highlights
of Day 1, focusing on the common issues of concern raised
during the country presentations as follows:
? Background and status of GMCs: Agriculture plays an important
role in national economies and development, as most of the
populations reside in rural areas. Biotechnology presents
potentials and risks. The development of biotechnology varies
among participating countries. There is limited public understanding
about the potentials and risks involving GMOs and GMFs, and
biotechnology and biosafety remain controversial issues.
? Policy, legislative framework/regulations and mechanisms
related to biotechnology and biosafety: Many countries already
have a number of regulatory guidelines, although some are
not specifically directed at GMOs/GMFs/biotechnology. In most
countries, biosafety issues fall under the responsibilities
of different ministries and authorities. Various committees,
sub-committees and institutions have been established to deal
with relevant issues.
? Training and research needs: A wide range of training needs
was addressed, such as risk assessment, monitoring, public
awareness (including outreach, human resource development),
biosafety guidelines and regulations. Country delegates also
stressed the importance of R&D on biotechnology and biosafety,
which contributes to, inter alia, capacity building, raising
public awareness and increased crop productivity.
? Asian Bionet: The delegates agreed on the importance of
the Asian Bionet, which will improve harmonization and information
exchange among participating countries.
VII. PLENARY II
64. Prior to issuance of the guidelines provided by the Plant
Biotechnology/Biosafety Specialist, the delegates agreed,
following a suggestion by a Malaysian representative, to prepare
a matrix to analyse strengths and weaknesses. A small group
would draft the matrix to be filled out by the participants
and discussed during Day 2. The UNEP-GEF representative stressed
the importance of discussing about cross-cutting issues, particularly
the issue of capacity building.
Guidelines on Discussions/Plenary Sessions
65. The Plant Biotechnology/Biosafety Specialist thanked
the participants for their contribution on Day 1. He provided
some guidelines for discussion during Day 2, which would focus
on cross-cutting issues related to biosafety. Resource persons
would highlight some of the key issues, followed by general
discussions. Capacity building would be a key subject and
the delegates would be expected to draw up concrete action
plans to facilitate the effective implementation of the project.
Legislative Framework including Harmonization of Biosafety
Procedures
66. Dr Fee-Chon Low, Biosafety Expert, the Ministry of Science,
Technology and the Environment of Malaysia stated that the
finalization of the Cartagena Protocol under the CBD was a
cornerstone in the development of an international legally
binding instrument to address biosafety. The Cartagena Protocol
deals with the issues regarding transboundary movement of
GMOs and allows countries to make informed decisions on whether
to import GMOs. The successful implementation of the Cartagena
Protocol, however, is contingent on the establishment or development
of a national framework for biosafety, which constitutes a
priority for all countries.
67. Despite country diversity, the legislative framework
for biosafety will have common elements such as scope, objectives,
institutional administrative structures, application and authorization
processes, review and revocation procedures, public awareness
and enforcement. In general, biosafety procedures will involve
systems to handle advanced informed agreement (AIA) information
pertaining to imports and application; mechanisms to review
application; decision-making; facilities for inspection and
monitoring; and responses for public information and participation.
68. Regional harmonization needs to be sought in areas not
impinging on the sovereign rights of nations, such as safety
reviews and the reporting of dissemination on decisions and
sharing of information related to biosafety. Information exchange
is a potential area for regional cooperation, juxtaposed with
the joint development of authoritative biology documents for
crops most important to the region. Information sharing on
risk assessment/management and monitoring is also important,
as well as the joint production of outreach materials for
public awareness.
69. Dr Ken-ichi Hayashi, Vice-Chairperson of the OECD Working
Group on Harmonization of Regulatory Oversight in Biotechnology,
provided an overview of the activities and initiatives on
the harmonization of biosafety procedures. He stated that,
despite differences among countries regarding positive and
negative GMO issues, it is important to create mutual understanding
related to biosafety, such as collaborative work on the harmonization
of biosafety procedures.
70. Past activities and programmes on biosafety in accordance
with the development of biotechnology include, inter alia,
OECD initiatives to develop the concepts of “familiarity”
(for environmental safety) and substantial equivalence for
food safety; accompanied by biannual international biosafety
symposiums supported by the goodwill and enthusiasm of participating
countries for the development of agricultural biotechnology.
71. Efforts concerning the harmonization of biosafety procedures
are geared towards assisting countries in their regulatory
oversight activities especially with regard to ensuring safety
and generating more transparent and efficient policies. Harmonization
promotes mutual understanding, reduces duplication and increases
efficiency which in turn improves safety and avoids unnecessary
disputes. For 2003 to 2005, the following areas of activities
are envisaged for the OECD Working Group: preparation of consensus
documents as a compilation of information related to the safety
evaluation of transgenic crops; outreach activities, including
information exchange and dissemination for the evaluation
of biotechnology safety by governments and industry; and a
workshop on consensus documents and other issues.
Synthesis of the General Discussion
72. The keynote speaker pointed out that the work of the
OECD is very important particularly its outreach activities
under the Harmonization of Regulatory Oversight in Biotechnology
Working Group, which takes into account the views of non-member
countries. It would be useful for the countries of the region
to consider expressing opinions about the species of GMCs
and submitting comments on existing documents. The ICCP is
a repository of valuable information.
73. The Crop Life Asia representative observed that while
the NBF can precede policy-making, it appears that having
policies in place contributes to obtaining political support
from decision-makers, rendering the NBF process smoother.
Related to this point, given the limited information on policies,
compiling a list of such information would be useful. The
representative from FAO headquarters noted that the FAO Web
site contains relevant information.
Public Participation/Stakeholder Involvement
74. Ms Lin Li Fen, Third World Network, stressing the importance
of public participation, indicated that there are provisions
for public participation in Article 23 of the Cartagena Protocol
which requires Parties to, inter alia, promote and facilitate
public awareness, education and participation; endeavour to
ensure that there is access to information for public awareness
and education; and consult the public in the decision-making
process and to communicate the results. Public participation
on a matter as delicate as genetic engineering is a matter
of democracy, transparency, accountability and collective
responsibility.
75. Meaningful public participation should be anchored on
public awareness and education; rather than educating the
public on a certain point of view that is biased towards policy
decisions that have been adopted already, public awareness
and education must honestly air the scientific uncertainties
and debates, and ethical and socio-economic concerns. In the
area of genetic engineering, there are almost no independent
peer-reviewed scientific data on research to establish the
safety of GMOs. While some concerns over GMOs still need to
be scientifically verified, so also must the claims of benefits,
as the extravagant propaganda surrounding the technology is
so great that many resources are being diverted into it, at
the expense of other options.
76. Public awareness and education start with admitting what
we do not know and what science does not know. A challenge
is communicate scientific issues to the public in an understandable
manner, so that the public can decide for themselves, as science
and technology are supposed to serve the needs of society.
It should also be stressed that the real test of a government’s
commitment to public awareness and participation lies in its
efforts to reach out to the unorganized sector of society.
The public should have an opportunity to be involved in the
decision-making on matters that affect them.
Synthesis of the General Discussion
77. The importance of public involvement in biosafety issues
was echoed by a number of participants. In this connection,
the Third World Network delegate answered an inquiry on effective
ways of public consultation other than the Internet engine.
Public consultation in New Zealand is carried out in an innovative
manner, in which people send their comments in writing. In
parallel, a series of public consultations has been held nationwide.
The UNEP-GEF representative added that the effectiveness of
this approach lay also in its cultural sensitivity to hold
consultations with the indigenous population.
78. The Crop Life Asia delegate pointed out that it is important
to understand the dilemmas of the regulators who have to devise
policies and regulations amid uncertainties of issues that
are currently unknown but may be clarified in the future.
Regarding farmers’ participation (the need for which
was reiterated by many participants) he attributed their limited
participation to the small number of organizations that represent
their interests. The Third World Network delegate added that
very limited information on biosafety is disseminated to the
public, and GMOs and GMFs are commercialized often without
public consultation.
79. The keynote speaker added that each country should consider
the level of public participation it wishes to ensure, both
at the national and local levels. To address the issue of
transparency, the regulators need to identify areas of uncertainty
that have negative implications, which in fact, can be areas
of future research. Another issue is to involve scientists
from various disciplines including social science.
Vision and Scope Document for SPFS Asia Information
Management System
80. Dr Ajit Maru of the ISNAR Biotechnology Service, on behalf
of Mr Michael Riggs, FAO-RAP, explained that the Special Programme
for Food Security (SPFS) has been a major FAO initiative since
1994. Its main objective is to assist low-income food deficit
countries (LIFDCs) to improve food security at national and
household levels, through rapid increases in food and production
and reduction of year-to-year production variability. The
SPFS Asia Information Management System (SAIMS) addresses
the consistency of the information management framework and
tools, which underpin the overall evaluation of SPFS projects.
81. SAIMS will serve as a central repository for SPFS project
information outputs, being a common platform for accessing
and managing information and data from different countries
on the Internet. It will be easy to use, reducing the workload
of data management while eliminating the need to respond to
individual requests for data from other stakeholders. Its
main features include: a Web-based user interface for data
management and system administration; a central data warehouse
containing country-level data and the potential for managing
more complex data; search facilities; a user interface accessible
by those without advanced computer literacy; and information
access controlled by an identification process.
82. FAO WAICENT has been established as a strategic framework
for FAO in connection with agricultural information management
and dissemination. As a corporate framework, WAICENT integrates
and harmonizes standards, tools and procedures for the efficient
and effective management and dissemination of high-quality
information products. In addition to WAICENT, FAO’s
Asia-Pacific Information Management activities include livelihood
approaches to ICTs (Information Communication Technologies)
in support of rural development and food security; information
management for food security; a Virtual Extension-Research
Communication Network; and a Rural Community Information Network.
Synthesis of the General Discussion
83. The delegate from FAO headquarters reminded the participants
that this consultation could discuss the way in which to profit
from FAO’s expertise and experiences to facilitate the
establishment of the Asian Bionet. He encouraged the participants
to contribute ideas about information to be included in Asian
Bionet.
84. The Indonesian delegate observed that existing Web sites
feature scientific information, but very little useful information
for farmers. The ISNAR representative referred to the need
to include the entire community affected by biotechnology.
The question of “who holds the responsibility to inform
the public” is also critical. Support to reinforce weak
national systems, and consequently regional systems, as well
as the capacity building of the public to make informed decisions
is another key issue. An FAORAP representative remarked that
FAO would be in a position to support national authorities
in this regard. Related to this point, the national project
coordinator from Indonesia stressed the importance of reinforcing
the communication skills of scientists who often have difficulty
in expressing information articulately for farmers.
Research Needs for Biosafety in GM Crops
85. Dr Dolorez Ramirez from the University of the Philippines
at Los Baños explained that biosafety, which is not
a concern in crops improved by conventional plant breeding
methods, has become a key research agenda for GMCs. Biosafety
research is focused on food and feed safety, and on environmental
safety. The safety of new GMCs for consumption should be assessed
on a case-by-case basis.
86. The R&D agenda for food and feed safety should revolve
around the safe consumption of the introduced DNA and of newly
produced protein; the biochemical and physical properties
of newly produced protein; and the composition and nutritional
values of new GMCs compared to non-GM counterparts. Food and
feed safety research should include substantial equivalence
of the GMCs; toxicity and antinutritional studies; allergenecity
tests and animal performance tests.
87. The R&D agenda for environmental safety should address
direct and indirect ecological effects. Direct ecological
effects involve gene flow, weeds and the relative fitness
of the GMCs. Indirect ecological effects include the effect
of the GMC production and processing systems on the non-GMC
production and processing systems; food chain links between
the GMCs and the native flora and fauna; and the effects of
GMC cropping systems on biodiversity. Monitoring during commercial
production of GMCs will determine, inter alia, compliance
with regulatory requirements; assessment of environmental
quality; and occurrence of unexpected or potentially damaging
effects. Research along these lines will help to identify
the appropriate interventions in order to prevent undesirable
environmental impact. Furthermore, research findings are expected
to enhance the risk assessment protocols and assure that GMCs
are safe as food and feed and are environmentally friendly.
Environmental Impact Assessment of GM Crops in Japan
88. Dr Mitsunori Oka, Director, Department of Environmental
Safety, National Institute of Agro-Environmental Sciences,
explained that with the fiftieth ratification of the Cartagena
Protocol by the Republic of Palau on 13 June 2003 and its
passing into effect 90 days later on 11 September 2003, as
well as the approval of municipal law in line with the Cartagena
Protocol, biosafety research and regulations in Japan are
afforded top priority.
89. The safety assessment of GMCs (in environmentally isolated
fields) in Japan concerns gene existence and expression, morphology
and growth characteristics and environmental impact. Japan
is implementing a comprehensive research project on the assurance
of the safe use of GMOs from 1999 to 2006, to guarantee GMO
safety and win public acceptance, and to address food and
environmental problems. The project aims to develop methodologies
required for the safety assessment of the application of recombinant
DNA techniques; classify the impacts of GMOs on other organisms
and on the environment; and study the global needs for GMOs
and their public acceptance through public opinion surveys.
Organized by the National Institute for Agro-Environmental
Sciences, it involves nine national institutes, five universities,
six public institutes and five private and semi-autonomous
research organizations.
90. Research conducted to date has examined: gene flow (such
as the field arrangement of two maize varieties for pollen
donors and recipients, and estimation of the crossing rate
by xenia in maize); the distribution of crossing plants and
the decline of the crossing rate in the field; the effect
of Bt-maize pollen on non-target insects; and the biosafety
of GM maize pollen toxicity. Allelopathy and evaluation are
undertaken at various interaction points between plants and
other life forms by natural chemicals. Public acceptance of
GMCs in Japan begins with the provision of basic knowledge
on GMCs by experts to the public. This is followed by questions
and answers by citizen panels, to be answered by experts as
well as citizens. Based on discussions at consensus meetings
on GMCs, citizens formulate proposals for investigation and
research.
Synthesis of the General Discussion
91. A Biotec representative inquired about the effect of
GMCs on micro-organisms, and about the impact of rotation.
It was explained that the effect appears to be considerable.
However, it is necessary to draw up lines on how much research
is needed. It was also noted that flora changes are not necessarily
due to the influence of GMCs. More information is needed concerning
crop life. Longer-term monitoring is also necessary. The ICRISAT
representative referred to the long-term development of GMCs
to respond to insect resistance. The FAO headquarters’
representative suggested that on this issue, information sharing
can play a role. For example, the information presented by
Japan could be useful for other countries.
92. The ISNAR delegate remarked that risk is also a matter
of perception. Socio-economic issues (soft-science issues)
need to be taken into account. The Chairperson repeated the
importance of scientific information as a basis to address
non-scientific issues, including legislative frameworks and
public awareness.
GMO Detection
93. Dr Apichart Vanavichit, on behalf of Dr Somvong Tragoonrung,
DNA Laboratory, Biotec, explained that genetically engineered
plants and animals are the primary issues in the food market.
There are two major methods to produce transgenic plants.
Employing Agrobacterium tumefaciens includes infection; co-cultivation,
gene expression testing, and tissue selection; while the particle
gun method involves a gene-coated particle gun, tissue selection,
and gene expression testing on plant cells/tissues. There
are two sources of genes used in transgenic plants, i.e. the
plant gene itself and genes from other organisms.
94. Transgenic development aims at providing benefits for
farmers and for seed companies; and responding to public concerns
about GMO safety issues such as the long-term effects of consumption,
as well as addressing issues related to environmental impacts,
intellectual property rights and religion. GMO analysis is
conducted using samples such as raw materials, processed products
and highly processed products. The steps followed are sampling,
DNA isolation, polymerase chain reaction (PCR) and analysis
of PCR results.
95. Almost all commercially developed transgenic crops will
contain either the CaMV35S promoter (Cauliflower Mosaic Caulimovirus)
or the NOS terminator (Agrobacterium tumefaciens Ti plasmid).
GMO analysis needs to take into account whether DNA has been
extracted successfully from the samples; if there is any contamination
during the DNA extraction process or the PCR reaction step;
and if there is any experimental error. As for labelling,
countries have different regulations. Thailand, for example,
established a 5 percent threshold for labelling as of April
2000 (to enter into effect in May 2003).
Synthesis of the General Discussion
96. A Biotec representative inquired about internationally
standardized methods for GMOs. It was explained that currently
five laboratories in the world work on this issue, on a personal
contact basis. The FAO headquarters’ representative
observed that this presentation demonstrated example areas
for regional cooperation, such as doublechecking of test results;
the possibility of using facilities existing in a country
for the testing of materials of other countries; and training
on relevant fields.
Segregation, Traceability and Identity Preservation
(STIP) Systems — Implications for the Use of GMOs
97. Dr Ajit Maru, ISNAR Biotechnology Service explained that
the issue of segregation, traceability and identity preservation
(STIP) is in general relevant for all processed crops including
livestock, organic and tailor-made crops, and is not limited
to GMCs. STIP is very important because of the increasing
specificity in agricultural commodity markets, the widening
demands for maintaining product safety and the growing concern
about marked failures and liabilities. However, as far as
implications for developing countries are concerned, the STIP
system and labelling for GMCs entail extra cost; more complicated
agriculture; the need for new regulatory organizations, mechanisms,
laboratories and the capacity to manage the information system
and small farmers’ organizations; and lower participation
in global agricultural trade.
98. He also explained about the Programme for Biosafety System
(PBS), which is a US$14.8 million award from the United States
Agency for International Development (USAID) mainly to assist
developing countries in enhancing biosafety policy and research.
The PBS will be run by a consortium of professionals and institutions
and will work initially in countries such as Bangladesh, India,
Indonesia, the Philippines, as well as West and East Africa.
Its mission is to empower partner countries for science-based
biosafety decision-making while strengthening capacity to
implement biosafety through initiatives in system design.
Its overall goal is to address biosafety effectively within
a sustainable development strategy, anchored by agriculturally
led economic growth, trade and economic objectives.
99. The PBS will assist national governments in studying
policies and procedures for evaluation and management of the
potential harmful effects of modern biotechnology on the environment
and human health. Its goals are to improve regional cooperation
on various subjects related to GMOs and expand management
skills; to assist governments in making science-based decisions
on the effects on biodiversity through the introduction of
GMOs into the environment; and to assist partner countries
in regulating and safely conducting experimental field trials.
Synthesis of the General Discussion
100. A Philippine representative referred to the difficulty
in undertaking proper labelling. This is partly attributable
to the similarities between GMOs and non-GMOs, but also to
the influx of GMOs from countries which do not segregate GMOs.
This is an issue to be addressed both by exporting and importing
countries. In this connection, the keynote speaker reiterated
the importance of GMO traceability. It would be useful to
keep record of products that are approved or not approved
in different countries.
UNEP-GEF Projects on National Biosafety Frameworks
101. Dr Nizar Mohamed, UNEP-GEF Biosafety Unit, Regional
Coordinator for Asia and the Pacific, International Environment
House, spoke about UNEP-GEF projects on national biosafety
frameworks. The total cost is US$38.4 million, of which US$26.1
million is provided by the UNDP-GEF, including co-financing
between UNEP and 150 participating countries. The projects
aim at preparing countries for entry into force of the Cartagena
Protocol; assisting eligible countries to establish NBFs;
promoting regional and sub-regional cooperation; providing
technical support for the production of NBFs; and strengthening
of synergies with other agencies and initiatives.
102. The projects identify key elements for all NBFs, namely,
regulatory systems; administrative systems; risk assessment
and management; and public awareness and participation. Project
execution follows four steps involving starting up, information
gathering, consultation and analysis and drafting of the frameworks.
The projects include activities at global, regional, sub-regional
and national levels, covering respectively provision of information
and support, understanding of the Cartagena Protocol and exchange
of different experiences, training and capacity building and
development of NBFs.
103. Interactive sub-regional workshops aim at building capacities
in (i) risk assessment and management; (ii) public awareness
and participation; (iii) administrative systems; and (iv)
regulatory systems. The second round of training workshops
was held from November 2002 to May 2003 with a particular
focus on risk assessment and management along with public
awareness and participation. The third round of training workshops
will be organized from the second half of 2003 with principal
attention being focused on regulatory and administrative issues.
As of June 2003, 118 countries from Africa, Latin American
and Caribbean countries (GRULAC), Central and Eastern Europe,
and Asia and the Pacific will participate in the projects.
104. Since September 2002 UNEP-GEF has been implementing
another series of projects on the implementation of NBFs.
With an average duration of three years and a US$70 000 budget,
eight participating countries undertake national level activities
concerning biosafety policies, regulatory regimes, systems
to handle requests, monitoring and inspections, as well as
public information. In addition, a new UNEP-GEF project on
capacity building for the use of the biosafety clearinghouse
(BCH) is presently under development in collaboration with
the CBD Secretariat. The project will be designed to meet
the physical capacity and capacity building needs of eligible
countries that are parties to the Cartagena Protocol and to
train them in access, use and entry of data into the BCH.
Furthermore, the GEF Council has set aside funds to support
implementation of NBFs when the Cartagena Protocol is effected
in September 2003.
Synthesis of the General Discussion
105. The discussion centered on the draft matrix presented
by the designated group, which would be elaborated on Day
3. The AVRDC representative suggested clarifying specific
timeframes. The Plant Biotechnology/Biosafety Specialist reminded
the meeting that activities would need to be concluded within
the project duration. It was stressed meanwhile that, with
sustainability being the objective of the project, FAO would
expect the activities to continue via voluntary initiatives
from the participating countries after the project has been
completed.
106. The participants agreed that the matrix covered most
of their needs. In the meantime, some additions and modifications
were suggested. The FAO heaquarters’ representative
raised issues from the first day’s discussion, namely,
training on information management, capacity building on intellectual
property rights — including the possibility of public–private
partnership. His suggestions were supported by a number of
participants. Further additions and modifications to the matrix
included: biosafety in human resource development to be upped
to first priority from the second position (India, Pakistan);
detection and verification mechanisms including the possibility
of using facilities in other countries (India, Pakistan, Sri
Lanka, Thailand); information management, including dissemination,
to be prioritized (India, Pakistan, the Philippines); coordination
of research projects (Sri Lanka); a biotechnology regulation
system including policies to be upped to first priority from
the third position (Thailand; Viet Nam); coordination of government
ministries within the country (Thailand); promotion of multi-disciplinary
efforts to include industry and farmers (Thailand); and the
establishment of a code of conduct (Thailand).
107. Concerning project implementation, the UNEP-GEF representative
asked about the possibility of expanding member countries
to include Lao PDR, Cambodia and Myanmar. It was explained
by the Project Secretariat that this topic would be discussed
on Day 3. Japan reiterated the need to focus on priority areas
of the project given the limited time and budgets. The FAO
headquarters’ representative thanked the Japanese government
for supporting the project, for which he hoped there would
be swift implementation, despite the late start owing to various
problems. Expanding the number of participating countries
and the scope of the project is envisaged, by attracting additional
support not only from Japan but also from other donors. Further,
while this is a regional project, FAO is in a position to
consider proposals for national-level projects which complement
the project.
108. The Plant Biotechnology/Biosafety Specialist reminded
the delegates that the establishment of the Asian Bionet was
a critical issue for Day 3. He encouraged the active participation
of the participants. Day 2 concluded with a vote of thanks
by the Chairperson at 1700 hours.
DAY 3
109. The Chairperson informed the participants of the revision
in the agenda for Day 3, which was agreed by the participants
(Appendix 1).
Capacity Building in Biosafety of GM Crops in Thailand
110. Dr Songkran Chitrakon from the Office of Biotechnology
Research and Development, Department of Agriculture of Thailand
explained that scientists in Thailand feel free to conduct
R&D using modern biotechnology. However, the government
does not allow the release of genetically modified plant varieties
for commercial purposes if they have not been scientifically
proven to be safe. Further, the importation of GMOs into Thailand
is prohibited. In the meantime, Thailand adopted its own biosafety
guidelines in 1992. The draft policy on GMFs and agricultural
products (2002–2006) touches upon six areas of policies:
on production; on human resource and technical development;
on biosafety evaluation; on trade; on public relations; and
on public participation.
111. Under the notification of the Thai Ministry of Agriculture
and Cooperatives (MOAC) in 1994, 40 transgenic plant species
were specified as prohibited materials unless permitted by
the Department of Agriculture (DOA) as solely for experiment
and research. To date, the DOA has approved the importation
of six GM plants for experiments, namely, Bt-cotton resistant
to cotton bollworm, Roundup-Ready™ maize, herbicide-resistant
cotton, extended shelf-life tomato, papaya resistant to ringspot
virus, and rice resistant to bacterial leaf blight. Most research
on transgenic plants, with emphasis on economic plants has
aimed at acquiring resistance to insect pests, diseases and
extreme environmental conditions. Most of the experiments
are in progress and being tested in the greenhouse and in
field trials, in strict accordance with the Biosafety Guidelines.
112. Dr Chitrakon’s recommendations are to promote
coordination among national government agencies in the formulation
of policies and biosafety implementation strategies; to foster
regional cooperation for biosafety and capacity building in
line with existing international regulatory mechanisms; to
enhance multidisciplinary research; to provide training on
risk analysis; and to develop a code of conduct for safe,
transparent and widely publicized application of biotechnology.
VIII. Presentation of the Summary of the Plenary
Session
113. The Rapporteur recaptured the highlights of Day 2 as
follows:
? The agenda for Day 2 consisted of presentations by resource
persons followed by general discussions. The issue of capacity
building was given priority, with a view of achieving concrete
action plans to facilitate the effective implementation of
the project.
? Emphasizing the importance of the Cartagena Protocol, the
participants reiterated the need to prioritize, inter alia,
issues related to the transboundary movement of GMOs; development
of NBFs; taking regional harmonization with national diversities
into account; information exchange and management, risk assessment
and monitoring; public awareness building (outreach) and informed
participation; effective R&D; and proper labelling.
? The participants shared information on ongoing initiatives
such as the OECD Working Group on Harmonization of Regulatory
Oversight in Biotechnology, FAO SAIMS, WAICENT and Asia-Pacific
Information Management, Japan’s comprehensive research
project on the assurance of safe use of GMOs, STIP and PBS
by ISNAR, UNEP-GEF projects on national biosafety frameworks
and another series of projects on NBF implementation.
? The participants recognized the importance of discussing
the establishment of the Asian Bionet for participating countries
and all the stakeholders, including farmers.
? Participants also discussed the matrix, indicating priority
areas. Most participants commented that the matrix covers
most of their needs. Concrete modifications suggested by the
participants would be duly taken into account and reflected
in the revised matrix.
IX. JOINT STEERING COMMITTEE AND TECHNICAL EXPERT
GROUP MEETING
Composition of the Steering Committee and Technical
Expert Group
114. The Plant Biotechnology/Biosafety Specialist informed
the participants that the Steering Committee consists of the
heads of leading biosafety agencies or designated government
representatives in the participating countries, FAO, representatives
from CGIAR centres, representatives from NGOs, and representatives
from the private sector. The Technical Expert Working Group
is composed of heads of national biosafety committees, institutions
or designated representatives of the participating countries.
115. In response to an inquiry from a Malaysian representative,
the FAO Project Secretariat explained the Steering Committee
would focus on overall supervision and provide guidelines,
while the Technical Expert Working Group would deal with general
management and technical issues. The participants requested
the Project Secretariat to formulate the terms of reference
(TORs).
116. Concerning the members to be included on the committee,
the UNEP-GEF representative suggested that the UNEP-GEF Project
Steering Committee members should be included, in order to
reinforce mutual benefits and reduce duplication. The national
project coordinator from Indonesia recommended that members
should be selected from the Ministry of Agriculture and the
Ministry of Environment. The Indonesian representative suggested
the inclusion of BIOTROP to reinforce the database. The resource
person from the Malaysian Ministry of Science and Technology
and the Environment observed that, instead of directly involving
a plethora of existing networks in each country, the Steering
Committee should consist of country representatives, while
maintaining links with relevant networks. It was further suggested
by the participants that JIRCAS should be included on the
Steering Committee.
Formulation of Specific Activities
117. Based on the priorities identified through the matrix
analysis, the FAO headquarters’ representative presented
a preliminary proposal for specific activities. Concerning
monitoring, in order to address the needs for human resource
development and validation of protocols and results, possible
activities could include regional practical training courses
on GMO detection; and laboratory networking for the exchange
of protocols, twin analyses, secondary verification and so
forth. As for needs related to risk assessment/management
procedures, namely, human resource development and the development
of agreed guidelines (consensus documents), national training
workshops and regional technical workshops can be considered.
In order to promote public awareness, for which the need for
public outreach materials was identified, the production of
common basic materials to be translated into local languages
and dialects (possibly accompanied by training on communication)
was proposed. Further, to respond to additional human resource
development needs such as intellectual property rights, public
private partnerships and information management, a national
training workshop was proposed (possibly in conjunction with
a regional workshop).
118. The representative from the Society for Techno-innovation
of Agriculture, Forestry and Fisheries pointed out that agreed
guidelines and the consensus document refer to different materials,
with the latter being a neutral scientific/biology document.
119. The representative from the Malaysian Ministry of Science
and Technology and the Environment stressed the importance
of reinforcing partnerships with existing international agencies
to build on existing activities while reducing duplication,
particularly UNEP-GEF (on public involvement) and ISNAR (on
intellectual property rights and information sharing). This
suggestion was welcomed by the UNEP-GEF and ISNAR representatives.
120. The keynote speaker noted that for human resource development,
workshops do not necessarily produce long-term impacts. It
would be useful to utilize existing in-country networks through
Internet-based communication. In this connection, a roster
of experts and possibly the advisory committee at the regional
level can be considered. The Crop Life Asia delegate added
that the project can source existing mechanisms and frameworks
such as the Asia Food Information Center and the International
Food Science Center.
121. The Indian representative reiterated India’s willingness
to share its experience on Bt-cotton. She also pointed out
that support from Japan, which is the largest importer of
GMCs, will be useful, particularly regarding the detection
and verification of imported GMCs. Further, in order to complement
regional workshops, countries can submit lists of concerned
officers and stakeholders to be included in the network of
information exchange. Further comments on proposed activities
included the need to present general proposals rather than
specific ones (the Philippines); to consider hands-on training
in addition to IT-based training (Pakistan); to highlight
country-specific needs and initiatives (Malaysia); to address
socio-economic aspects (Indonesia); and to emphasize monitoring
of transgenic risks (China).
122. The participants discussed subjectivity involved in
the interpretation of terminology, despite the availability
of reference materials that contain standard interpretations.
The representative from the Society for Techno-innovation
of Agriculture, Forestry and Fisheries advised that for the
TORs and proposed project activities, it would be useful to
use the terms in a general manner.
Establishment of the Asian BioNet
123. The Plant Biotechnology/Biosafety Specialist explained
about the conceptual framework of the Asian Bionet. While
the secretariat can be established initially within the FAO
office, the Asian BioNet should be sustained, as a mechanism
of regional collaboration and information exchange, upon the
completion of the project.
124. A Malaysian delegate suggested that the establishment
of the Asian Bionet could refer to an ASEAN (Association of
Southeast Asian Nations) Bionet. The participants stressed
that the project should seek linkages with existing initiatives
such as the biosafety clearinghouse under the CBD and sub-regional
Web sites, rather than duplicating them.
125. The FAO headquarters’ representative probed the
participants’ opinions on the need for an Internet-based
network; contents of this network (whether to include official
and unofficial/unauthorized information); and ways to maintain
it. The participants requested the Project Secretariat to
prepare details on the Asian Bionet, in order to further consider
these issues.
Expansion of the Participating Countries
126. It was explained that a number of countries in Asia
and the Pacific including Nepal, Mongolia and Cambodia want
to join the project. The Japanese Government indicated the
difficulty in extending further support under the diminishing
ODA (Official Development Assistance) budget. Nevertheless,
this may be reconsidered depending on the project’s
performance. Meanwhile, the Plant Biotechnology/Biosafety
Specialist explained that non-participating countries may
be invited to some project activities such as training courses.
The UNEP-GEF representative suggested that, in order to attend
such training, these countries could seek resources other
than the project budget.
Drafting of the Report and Recommendations
127. It was agreed that the group including the Chairperson,
the Rapporteur and the FAO Project Secretariat would draft
the report and recommendations of the Regional Consultation.
X. CLOSING SESSION
Presentation of the Draft Report and Recommendations
128. The Co-chairperson presented the draft recommendations
(Appendix 2). The FAO headquarters’ representative explained
that this summary reflected the discussions carried out during
the Regional Consultation. Meanwhile, further additions could
be considered.
129. The Crop Life Asia delegate proposed that UNEP-GEF,
BIOTROP and JIRCAS should be included in the list of members.
It was clarified that this addition would be mentioned in
a relevant section of the proceedings of the Regional Consultation.
In connection with GMO detection, the Indian delegate said
that availability of laboratory facilities should be included.
The subjects covered by the national workshops, which appear
to be too encompassing, would need to be prioritized by each
country. The expression “public awareness related to
risk assessment” would need to be neutralized. The ISNAR
representative added that the recommended actions should be
guided and led by the Steering Committee, rather than subjecting
them in toto to the participating countries.
130. With the understanding that these comments would be duly
taken into consideration, the draft recommendations were adopted.
The Chairperson, Co-chairperson, the Rapporteur and the FAO
headquarters’ representative thanked the participants
for their valuable input.
Closing Remarks
131. The Plant Biotechnology/Biosafety Specialist concluded
the meeting by expressing his gratitude to all the persons
involved in the preparation and implementation of the Regional
Consultation. He indicated that this consultation offered
an arena for the representatives of participating countries
and organizations to meet for the first time and share valuable
information. He thanked the delegates for their active participation.
He expressed particular appreciation to Thailand, the host
country, as well as to the Japanese government for its support.
132. The Regional Consultation concluded at 1600 hours.
Appendix 1
REVISED DAY 3 PROGRAMME
0800–0815 Capacity Building for Biosafety in Thailand
Dr Songkran Chitrakon
0815–0830 Presentation of the Summary of the Plenary
Session
Chairperson/Rapporteur
Joint Steering Committee and Technical Expert Group Meeting
0830 –1030 Discussion
o Composition of the Steering Committee and Technical Expert
Group
o Formulation of Specific Activities
o Establishment of the Asian BioNet
o Expansion of the Number of Participating Countries
1030–1100 Coffee Break
1100–1500 Drafting of the Report and Recommendations
1500–1515 Coffee Break
1515–1645 Closing Session
o Presentation of the Draft Report and Recommendations
o Discussion and Adoption of the Draft Report
o Closing Remarks by Dr Susumu Kawabe
Appendix 2
REGIONAL CONSULTATION — “CAPACITY BUILDING IN
BIOSAFETY OF GM CROPS IN ASIA” (GCP/RAS/185/JPN)
Agriculture plays an important role in national economy and
development, with most of the population residing in rural
areas. Biotechnology has potentials but its development is
varied among participating countries. The benefits and potentials
of GMOs and GMFs are recognized among a certain percentage
of the population and authorities, but they remain controversial
issues.
In this context, the Regional Consultation on “Capacity
Building in Biosafety of GM Crops in Asia” was held
from 7 to 10 July 2003 at the Century Park Hotel, Bangkok,
Thailand. The participants included participating countries
in the project (Bangladesh, China, India, Indonesia, Malaysia,
Pakistan, the Philippines, Sri Lanka, Thailand, Viet Nam);
Japan; representatives from UN Agencies, the CGIAR and other
international research centres, NGOs/INGOs and the industry
sector, resource persons and other stakeholders were also
present.
The meeting reiterated the importance of joint efforts, and
building upon existing initiatives and networks, in order
to reduce overlapping and reinforce coordination among participating
countries.
The meeting agreed on the following issues:
1. Capacity building through national or regional workshops,
networking and a roster of experts on, inter alia, human resource
development on biosafety; intellectual property rights; communication;
and information management. Countries are encouraged to seek
resources from various sources, in addition to this project.
There will be four regional training workshops to address
common needs and priorities, namely, RA/RM procedures including
monitoring; public awareness/risk communication; detection
of GMOs; and intellectual property rights. Ten national workshops,
one for each country, sponsored by the project, will be held
to address the specific needs of each country. Each country
may hold additional workshops as the need arises but they
should seek additional resources.
2. Standardization of procedures and methodologies for risk
assessment and risk management, including double verification
and GMO detection. A regional consultation on this subject
will be organized. Laboratory networking will be facilitated.
3. Public awareness on GMOs, including materials for public
outreach; and methodologies for effective outreach.
The meeting also agreed on the establishment of the Asian
BioNet, which will contribute to the coordination of stakeholders
and information sharing. The secretariat will prepare the
proposal for further consideration by the Steering Committee
and Technical Expert Group to facilitate the nomination of
the Second Meeting.
The meeting agreed that the Project Secretariat should formulate
the TORs to be sent to all the countries so they can express
their preferences as to the designation of the representatives
of both the Steering Committee and the Technical Expert Group.
In this connection, the meeting recommended the inclusion
of UNEP-GEF, BIOTROP, ISNAR and JIRCAS, NGOs and private sector
representatives.
The Project Secretariat will prepare the proceedings of this
consultation and send the document to the Steering Committee
for their comments before finalization.
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