Publications: ISAAA Briefs

Chan Ying Kwok
Assistant Director, MARDI

Supat Attathom
Director, PGEU, BIOTEC and Kasetsart University

and  

Anatole F. Krattiger
Executive Director of ISAAA

Contents

Foreword

From Indonesia: Sumarno    

From Malaysia: Md. Sharif Ahmad    

From Thailand:  Sakarindr Bhumiratana    

From the Philippines: William G. Padolina    

From Vietnam: Nguyen Ngoc Kinh    

Randy A. Hautea and Anatole F. Krattiger

• The Development of Virus-resistant Papayas in Hawaii: A Collaborative Project between the University of Hawaii and Cornell University

Richard Manshardt

• Summary of US Federal Government Biotechnology Regulatory Policies and USDA-APHIS Regulations and a Case Study on Rice

Sivramiah Shantharam  

• Biosafety in Field Trials of Transgenic Papaya: Learning from the Visit to Monsanto and the University of Hawaii

Chan Ying Kwok and Watchareewan Jamboonsri

• Application for Field Trial of Papaya Transformed with Resistance to Papaya Ringspot Virus Disease Malaysia's Draft Field Trial Application

• Evaluation of the Malaysian Field Trial Application

• Application for Field Trial of Papaya Transformed with Resistance to Papaya Ringspot Virus Disease Thailand's Draft Field Trial Application

• Evaluation of the Thai Field Trial Application

• Generic Questions and Answers on Risk Assessment for the Preparation and Review of Field Trial Applications of Transgenic Papayas in Southeast Asia

• Indonesia: Sumarno

• Malaysia: Low Fee-Chon

• Philippine: Agnes F. Zamora

• Thailand: Sutat Sriwatanapongse

• Vietnam: Le Tran Binh

• The Papaya Biotechnology Network of Southeast Asia

• Papaya Research and Development in Indonesia

Lilik Setyobudi and Sudarmadi Purnomo

• Papaya: The Industry and Varietal Improvement in Malaysia

Chan Ying Kwok, Mat Daud Hassan, and Umi K. Abu Bakar

• Papaya Production in Thailand

Wichai Kositratana, Orawan Chatchavankarnpanich, Kanokwan Kanokwaree, Watchareewan Jamboonsri, and Chalongchai Babprasert

• Status of the Papaya Industry and Papaya R&D in the Philippines

Violeta N. Villegas

• Papaya Research and Development in Vietnam

Le Tran Binh and Tran Thi Oanh Yen

• The Network Collaborators

The first widespread commercial introduction of transgenic plants in North America, Argentina, South Africa, and Europe began in 1996. By the end of 1998, approximately 28 million ha were planted with transgenic crops worldwide, the majority of which were grown in industrialized countries (James 1998). This introduction of the first wave of biotechnology products in industrialized countries is leading to further shifts in equity between developing and industrialized countries. Most of the products developed and commercialized so far were specifically for industrialized agriculture. The developing economies of Asia, home to the highest number of the world's poor, have yet to reap the benefits from agri-biotechnologies.  

Papaya Biosafety Workshop Participants at one of the working group sessions reviewing a biosafety field trial application

Among the different classes of agri-biotechnologies, genetically modified (or transgenic) crops have had the slowest rate of introduction into Asia. Aside from China, no other Asian country has grown single transgenic crops on a commercial scale. And despite Southeast Asia's relatively well-developed science and technology infrastructure and more than a decade of accumulated global experience in field testing and commercializing transgenic crops, only Thailand and very recently Indonesia have so far conducted experimental field trials of transgenic crops.

Various reasons have been cited to explain why the region has been slow to introduce and adopt transgenic crop technology in the region. Of these, the most important are the lack of effective biosafety regulations and an uninformed public sometimes skeptical about transgenic crops. By no means mutually exclusive, collectively these difficulties have led government regulators to take a conservative approach towards introducing transgenic crop products. This has delayed the use of superior agri-biotechnologies that could potentially make a difference in attaining the priority goals of food security, poverty alleviation, and environmental conservation. The lost opportunities to capture potential added values through improved productivity, increased income, and higher competitiveness carry high costs—particularly for the region's poor, who stand to benefit the most from such improvements.

ISAAA, the International Service for the Acquisition of Agri-biotech Applications, has conducted comprehensive studies to assess the biotechnology needs of five Southeast Asian countries (viz., Indonesia, Malaysia, Thailand, the Philippines, and Vietnam). These studies concluded that an immediate, urgent focus on policy issues—their technical, legal, regulatory, and social aspects, as well as their overall enabling environment—is required to ensure the efficient transfer, delivery, and use of agri-biotechnology applications and products in Southeast Asia. Leaving these important policy areas unaddressed could delay the adoption of all the products of biotechnology research in the region.

ISAAA's extensive experience in working with developing countries in Africa and Latin America to develop safe and effective biosafety regulatory procedures was considered a high priority area by ISAAA's partner countries to be replicated in Southeast Asia.

Dr. Richard Manshardt sharing his experience in developing and conducting field trials with transgenic papayas in Hawaii with workshop participants.

Biosafety Capacity Building through Technology Transfer

The use of transgenic crops has rapidly advanced since their first field tests and commercialization approvals in the US and other countries. Many of these advances were made possible by innovations in regulatory review processes as well as in science. The USA adopted biosafety regulations early on, and other developed countries followed basic models over the next several years.

Several developing countries have also established their own biosafety regulatory systems. And given that a biosafety protocol under the Convention on Biological Diversity will likely be adopted eventually, biosafety regulations could rapidly expand to a wider net of countries. For developing countries, the real incentive and motivation is a national one: an interest in testing locally emerging plant‑based technologies. These represent the next generation of agriculture and carry with them the promise of commercial survival in an increasingly competitive area. Without an appropriate biosafety regulatory system, countries should not¾and in many cases cannot¾test genetically modified plants and other organisms.

The five ISAAA partner countries in Southeast Asia all share the need for established and operational regulatory systems that will allow the timely testing and adoption of transgenic crops. Indonesia, Malaysia, the Philippines, and Thailand already have working biosafety regulations for field testing transgenic crops, while Vietnam has yet to establish such a regulatory system. But only Thailand and, very recently, Indonesia, have had actual experience in field testing transgenics. Each country possesses the sovereign right to establish its own regulatory guidelines. Acting accordingly, these countries have indicated that the process would greatly benefit from the experience of countries that have already implemented appropriate regulatory systems. Furthermore, pursuing such an initiative could enhance regional cooperation.

These five countries in Southeast Asia share many common needs in terms of crop biotechnology. Establishing the network will significantly benefit member countries by optimizing the use of limited resources to build critical mass in biotechnology capability at the national and regional level.

To accomplish this, a regional initiative could help develop the biotechnology transfer channel by using a “noncontroversial” technology. Given the capacity within the region to transform papaya and the importance of this fruit for resource-poor farmers in all five countries, delayed ripening technology and virus resistance to papaya ringspot virus (PRSV) are appropriate choices for a regional project. In addition to strengthening institutional frameworks, this project will also benefit farmers of all countries.

ISAAA's effort to assist these countries in developing and introducing a priority but noncontroversial transgenic crop could be an important pilot project. It could provide useful experience and confidence before these countries begin working on other genetically modified traits and crops that are more sensitive and complex. By facilitating the establishment of regulatory systems, the project helps to create the conditions in which respective sovereign states could assist their own agricultural research institutes in introducing their first transgenic crop—one that responds to a priority national need.

The Papaya Biotechnology Network of Southeast Asia

The Network was formally launched in March 1998, with the primary mission of contributing to improved  quality of life for rural and urban families in Southeast Asia. The program seeks to enhance income generation, food production, nutrition, and productivity for resource-poor farmers by integrating proven biotechnology applications into their agricultural practices. In the near term, the network seeks to positively impact the lives of resource-poor and small-scale farmers in Southeast Asia by increasing the availability of papaya for both food and¾through the sale of surplus fruit in local markets¾modest incomes.

Papaya is an “orphan crop” without a commercial market of any significance. Its genetic enhancement through the donation and transfer of proprietary technology from the private sector will greatly assist subsistence farmers who have not yet benefited from technology-based improvements. Furthermore, the papaya network will offer an institutional model for meeting the needs of the region's resource-poor, strengthening North-South and South-South cooperation through the donation, sharing, and transfer of proprietary biotechnologies.

The network will also help build a regional, harmonized regulatory system for implementing biosafety regulations, a prerequisite for testing and adopting any transgenic technology and germplasm. Jointly developing products that each country can use will be the primary method for achieving this goal. Although specific biosafety applications will be tailored to the unique products and specific requirements of each country, the ecosystem, papaya ecology, and many other areas related to biosafety are similar throughout the region.

Crucially, building biosafety capacity is linked to the acquisition and transfer of specific technologies applicable at the national level. This enables countries to focus activities around a specific, concrete case that builds capacity in every step necessary for success: from technology development and its application and regulation, to field trials and the distribution of the technology to farmers. This approach is the guiding rationale for the network.

The network's emphasis on developing a corps of national experts is designed to meet the need for highly credible, objective, scientific, and responsible oversight of the development and deployment of transgenic crops. Through such oversight and education, the public will gain a greater understanding of transgenic papaya and other transgenic products, which should ensure their general acceptance.

The Biosafety Workshop—Towards the Safe and Responsible Development and Use of Genetically Modified Papayas

At the outset, members of the papaya biotechnology network reported that it was very important for researchers involved in the development of PRSV and delayed ripening papayas to review biosafety issues from both scientific and ecological perspectives. Relevant documents and information were sought, such as the papaya biosafety regulations of the United States department of Agriculture (USDA) and the practical aspects Hawaii considered in developing safe and effective field trials. This information was particularly useful since Hawaii had already deregulated and commercialized PRSV papaya in the USA.

Randy Hautea during a field trip to MARDI's papaya fields.

The network also supports targeted activities to develop biosafety applications for transgenic papayas in each of the collaborating countries. This could include short-term internships in Hawaii to review processes that were followed, reviews made by the US regulatory agencies (USDA/Animal and Plant Health Inspection Service [APHIS], Environmental protection Agency [EPA], and the Food and Drug Administration [FDA]), biosafety documents, and to see first-hand field trials of transgenic papaya. Internships offer a learning-by-doing approach that ISAAA has facilitated elsewhere. ISAAA is convinced that people who have actively participated and executed tasks them-selves develop a better understanding and appreciation of problems and priorities. They also become better equipped to implement new ideas and modern technologies. Furthermore, internships tied directly to results-oriented, specific projects affect the whole spectrum of the “biosafety continuum.” The critical element for transferring transgenics to field testing in the papaya biotechnology network is a practical base that requires a high level of involvement from nationals, and that creates a corresponding high degree of motivation.

In view of this, ISAAA made biosafety capacity-building a top priority for the network and acted to facilitate the following activities:

• Prepared proposal and secured funding from the Rockefeller Foundation.

• Short-term study visits by selected network members to the USA (University of Hawaii and Monsanto).

• Regional Biosafety Workshop hosted by MARDI and Genetic Modification Advisory Committee (GMAC) of Malaysia at the Awana Genting Highlands, Malaysia.

ISAAA gratefully acknowledges the funding support of the Rockefeller Foundation, a major advocate for agri-biotechnology in developing countries, for the biosafety capacity-building component of the network. The Foundation's early funding commitment allowed the timely implementation of the biosafety activities.

Anatole F. Krattiger moderating one of the plenary discussions.

In preparation for the biosafety workshop, two scientists from the region—one each from Thailand and Malaysia—undertook a two-week study visit to the University of Hawaii and Monsanto, USA. The two most advanced countries in the development of transgenic papayas, Thailand and Malaysia, serve as regional hubs of the papaya network. They are anticipated to conduct the first field trials of their own transgenic papayas in the region. The internship was designed so that Thailand and Malaysia would be able to make a comprehensive assessment of all pertinent biosafety aspects for the development and commercialization of transgenic papayas based on the US experience. Their work would also make it possible for them to prepare an appropriate field trial application for transgenic papayas following their respective country guidelines and to assist other network member countries in preparing their own field trial guidelines.

Finally, the biosafety workshop was organized and held in Awana Genting Highlands, Malaysia, on 14-16 December 1998. The activity was coorganized and cosponsored by ISAAA, MARDI, and GMAC of Malaysia, with support from the Rockefeller Foundation.

 Workshop Objectives

• Formulate applications and protocols for field testing transgenic papayas in the member countries of the network in Southeast Asia in conformity with existing national biosafety regulations that could also serve as models for field testing other important transgenic crops in the region

• Share information and experiences between and among countries within and outside the region on biosafety regulations and their applications—particularly for papaya and other crops of importance to Southeast Asia

• Encourage and promote multi-stakeholder participation in ensuring the safe and responsible development, introduction, and use of transgenic crops in Southeast Asia

• Help enhance the capacity of national programs of member countries of the network to identify and effectively address key biosafety aspects of working with transgenic crops

• Promote regional and international cooperation in biosafety and food safety regulations for products derived from agri-biotechnology

Workshop Outputs

• Completed applications and protocols for field testing transgenic papayas in member countries of the network. A harmonized reference document for preparing and reviewing field trials of transgenic crops in Southeast Asia was also drawn up.

• Information, knowledge, and experience on biosafety regulations and experiences of selected countries within and outside the region were shared.

• Active and sustained participation of different stakeholders in ensuring safe and responsible development, introduction, and/or use of transgenic crops in the region.

• Enhanced institutional capacity of national programs and regulatory bodies to address biosafety concerns on transgenic crops and products.

• Increased national, regional, and international cooperation on biosafety and related regulations for agri-biotechnology.

Thus, direct benefits from the biosafety capacity-building activities include the following:

• The establishment of permanent and well-prepared members, advisers, and/or resource persons on biosafety committees who possess common understanding that will lead to more harmonized regional approaches,

• The creation of an invisible college in the Southeast Asian region for facilitating the effective review of field trial applications,

• Enhanced cooperation between countries in the sharing, joint development, and adoption of agri-biotechnology applications,

• Increased absorptive capacity for national programs to acquire, transfer, and adopt agri-biotechnology products.

These proceedings document and present the activities and outputs of the initial biosafety capacity-building in support of the Papaya Biotechnology Network of Southeast Asia.