Biosafety Regulations Under the Cartagena Protocol: The Jamaican Case*
Arnoldo Ventura
Office of the Prime Minister
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Financial support: OAS Project number AE 145-01 "Biosafety Regulations in Latin America and The Caribbean within the framework of the International Biosafety Protocol".
Abstract
Jamaica is an island with delicately balanced biodiversity and high endemicity. It also relies heavily on trade. Biosafety therefore is high on the island’s agenda, and the nation has been active in the Cartagena Protocol negotiations. Jamaica’s biotechnological competence allows the island to import as well as export transgenics. Nevertheless, to safely identify, test, handle, transport, store and use such organisms and their products, the island recognizes the importance of improving there capabilities. Additionally, to satisfy the obligations of the protocol a comprehensive legislation was also deemed necessary. Furthermore, to reduce costs and improve scientific coverage and efficiently, Jamaica feels that a Caribbean institutional approach to the implementation of the Protocol is essential.
Introduction
A wave of biotechnologies, over the last three decades, have given rise to fundamental changes in the global perception of life, economic possibilities, environmental impacts and social concerns. An unavoidable bio-revolution is said to be in progress.
A small country, like Jamaica, which depends heavily on trade of goods and services and which has a strong biodiversity base, sees both opportunities and challenges in these developments. The island, because of its high and fragile endemicity, therefore has a strong interest in questions of biosafety and consequently has been active in the Cartagena Protocol negotiations.
This paper seeks to outline the islands present biosafety situation and what has to be done to increase its capacity to manage and control the possibilities which arise with biotechnological products, and the rapid and frequent movement of species into new habitats.
Methods
The information contained in this paper was garnered from the analysis of written reports, policy interviews and personal observations, as well as, site visits.
Many discussions were held with key operatives in the Jamaican biodiversity and biosafety system, including members of the National Biosafety Committee, leaders in agriculture and agro-industry, members of the National Commission on Science and Technology (NCST), as well as, other concerned citizens, including leaders of consumer organizations.
About Jamaica
Jamaica is an 11,000 square kilometres Caribbean island 600 miles form the American mainland. The island has an exceptional diversity of topography, geology and climate. This has resulted in a high level of plant and animal endemicity, which ranks fifth among the islands of the world in plant endemicity. Recent research has revealed that many of the island’s species are poorly understood and that many are also under stress of extinction.
Jamaica can be considered a bio-economy, as tourism, agriculture and agro-industry, employs most of the island’s work-force and contributes over 15% to the island’s GNP and over 50% of its foreign exchange earnings. The natural beauty of the island originates largely from its varied vegetation, nestled in misty mountains and lush valleys, as well as, a coral reef ridge which supports golden sand beaches and cosy shores.
These facts have lead to a deep commitment to protect the nation’s biodiversity and maintain its natural beauty. Achieving satisfactory levels of biosafety is therefore top of the island’s priorities.
Jamaica’s current biosafety position
Jamaica sees biotechnologies, specifically elements of genetic engineering, as important to food security and safety on the island, as well as, its ability to increase production, add value and thereby compete in international markets. Considering the fragile nature of the islands environment, and its dependency on trade, there is no question that biosafety problems had to be systematically addressed.
Although in the early years of these endeavours there were efforts to catalogue and preserve biodiversity, there was little concern about biosafety. Biosafety issues began to emerge with the international debate about genetically modified (GM) foods and the commercial and environmental possibilities of transgenic plants and animals. These were raised largely by consumer groups and other non-governmental organisations (NGOs), as well as, functionaries within the NCST, the island’s science and technology management body.
Later, in the mid 1990s, the pressing need for a structured approach to these questions arose with the obligation to use transgenic papaya to replace the disease-infested plants on the island.
Jamaica’s science and technology policy, promulgated in 1990, explicitly expressed the need to use modern biotechnology to improve agricultural production, agro-processing businesses, medical treatments and the manufacturing of bio-products for local use and export. It was logical then for the island to seek ways to enhance its biotechnological competence.
A Biotechnology Centre was established at the University of the West Indies in the early 1980s, and this institution responded to the implicit call to boost the island’s biological knowledge in tissue culture, fermentation, embryo transplantation and other related areas of biotechnology.
Jamaica is not only a potential recipient, but also a supplier of GMOs, as it is currently conducting field trials on transgenic papaya, and undertaking research on the bio-engineering of tomatoes, peppers, and coconuts, and the development of Gemini virus vaccines. The island therefore has more than average interests in the Trade Related Intellectual Property Systems (TRIPS) agreement for food and farming. The request for the World Trade Organization (WTO) members to make patents available for all inventions, whether products or processes, in all fields of technology, including biotechnology, is being examined carefully in Jamaica. The island, because of its recognition of the importance of the proper handling of intellectual property rights, has established an Intellectual Property Rights Office, to cope with these matters.
Furthermore, the WTO deregulated approach to GMOs and their products, runs counter to the more cautious approach of the Cartagena Protocol, and this has forced countries like Jamaica to make unique judgements based on their own requirements and competences. The island has no choice but to become as knowledgeable as possible about the specifics in these matters.
Additionally, patents relating to processes, confer the right of the patentee to prevent the use of the products obtained directly by such processes. Accordingly, if processes to produce GMO plants were patented, exclusive rights would apply to these plants, including plants for food and pharmaceuticals. It is therefore incumbent on states, like Jamaica, to establish appropriate biosafety regulations and rules, before it can consider enactment of patent regimes that could encourage the development and release of such plants.
Need for Legislation
Approach
Legislation is needed in Jamaica, not only for the orderly introduction of GMOs, taking into account WTO rules and TRIPs, but also for safe handling of, and trade, in GMOs (Fisher, 1999). Although transgenic work is being conducted at the University of the West Indies, there is no mechanism to monitor this work, and none to guide and regulate the results of such research. In this regard, the field trials, with transgenic papaya, are being closely monitored by a National Biosafety Committee set up for this and similar purposes.
Jamaica has a National Biodiversity Strategy and Action Plan (NEPA, 2001) and a National Biosafety Framework is being developed to allow the island to implement the Cartagena Protocol on Biosafety, and thereby promote information sharing and collaboration, especially at the regional level, as well as, assist with capacity building to implement the protocol (Bernard, 2003).
Jamaica recognizes that they are two basic approaches to the adoption of biosafety rules (Little, 2003a). One regulating GM products using product based regulations, as exemplified by the fact that crops used as pesticides are regulated as pesticides, while food are assessed in relation to food safety rules. This is what exists in the USA and Canada.
This approach is in contrast to the technology-based regulations, which are applicable to all Living Modified Organisms (LMOs) in some countries. Here GM products are considered new and special, and therefore require new legislation. This is how the European Union handles this matter.
It is interesting to note that China uses a pragmatic approach, where regulations are basically product based, while attention is paid to the economic importance of a given application.
Jamaica has decided to take a pragmatic approach to the biosafety question, and not rely solely on either the product based, or process based, approach. Whatever the case, the island is aware that there are certain activities which must be addressed in formulating national biosafety frameworks. They are:
· the contained use of LMOs;
· field testing of LMOs;
· their large scale or commercial release into the environment;
· the import and export of LMOs; and
· the placing on the market of LMOs and/or products containing GMOs, such as seeds, foods and animal feed.
Legislating LMOs in Jamaica
From the Jamaican perspective it is likely that legislation will follow more a product based rather than a process based approach, as LMOs will not be specifically targeted (Little, 2003b).
The principal pieces of legislation that may have some implications for the handling of LMOs in Jamaica are the Plant Quarantine Act (1996) and the Plants Control Regulations (1997), the Animal Diseases and Importation Act, the Natural Resources and Conservation Authority Act, the Food and Drugs Act, the Standards Act, the Pesticides Act, the Public Health Act and the Pharmacy Act.
Although these pieces of legislations addressed aspects of the Cartagena Protocol, there is no complete coverage, nor coherence, of the domestic legislative scheme for this purpose. The various acts lack specificity for biosafety concerns as they were promulgated before such considerations were evident. They are at best facilitatory, since bringing biosafety issues within their scope lies in the regulatory powers of the responsible Minister.
Since shortfalls in the various local legislations can be identified, relevant recommendations can be made to fill the existing gaps. One significant area which is not addressed by any existing legislation, is the administration measures which will have to be established to do risk assessment and risk management. The necessary science, which must be invoked in this area, is similar in all jurisdictions, for example, a key component of environmental release is detailed environmental risk assessment.
This requires knowledge of the present state of the environment and the various change factors operating. Possible ways in which risks can be caused, minimized and/or avoided, can then be identified. A minimum amount of local testing and skills are therefore clearly required. Annex II of the Protocol sets out the procedure for the conduct of risk assessments, but these may have to be integrated and adopted in ways to accommodate the local environment.
There are many gaps in the various legislations in Jamaica and the existing framework therefore cannot satisfy all of the obligations under the Protocol. Consequently, there is need for a new comprehensive legislation. Accordingly, for effective implementation of the Protocol, Jamaica must see biosafety concerns as part of the overall development of the country.
In this regard, the island intends to set up ways to ensure that institutional learning progressively takes place to improve its knowledge and abilities in this area. Jamaica is more likely to be an importer of LMOs than an exporter, it is therefore recommended that the focus should be on broader measures to ensure that LMOs that are unsafe are not imported into the island. Those that are closely related to local endemic species should be strictly controlled or prohibited entry.
It seems reasonable, then, that a single piece of legislation should be enacted to take care of the biosafety issues, especially those concerned with transboundary movements under the Protocol. These have to be consistent with those under the Caribbean Community, and indeed, take into consideration the standards set by the WTO.
The legislation that will be promulgated must address the following issues:
Ø food safety and human health;
Ø plant and animal quarantine;
Ø pesticide and herbicide use;
Ø invasive species;
Ø biodiversity;
Ø endangered species;
Ø measurement of hazardous materials; and
Ø research and development and social intelligence in all these areas.
National requirements and training needs
Although Jamaica has a relatively well-organised science and technology infrastructure, with institutions operating in the major areas of an orderly science and technology system, it does not possess most of the essentials to comply with the tenets of the protocol to ensure the island’s biosafety (Wint, 2003). There is therefore need for strengthening, or acquiring, competence, in almost all the facets of biosafety. The island must decide on the mix of local competencies and capacities which are needed, and how these will relate to others which may have to be provided from the outside. Also, how to maintain and improve local capabilities within a dynamic environment, is considered vital.
Monitoring global findings
Although, there have been no verifiable ill-effects reported from the extensive consumption of products from GM crops by humans and life stock, over some seven years since they were introduced. Jamaica insists on the testing of such products, and where necessary, conduct some verification on its own. Jamaica also sees it important to acquire the capability to test all foods when necessary, whether they are the derivatives of GM, conventional or organic processes.
Nevertheless, for even greater safety, additional research, especially epidemiological surveillance, may be necessary. Jamaica intends to become party to similar international work, so that it can conduct independent surveillance when called for. Results from this type of research will inform not only the drafting of legislation, but also its progressive improvement, timely adjustment and its confident execution, at the local level.
The island has decided not to recline in comfort of the fact that GM crops may not be a significant problem, but has reasoned that the gaps in our present knowledge will surely increase when the range of plants and traits are expanded (UK Report 2003).
Local research needs
Clearly more research is needed to better understand allergencity, soil ecology, biodiversity and consequences of gene flow. Baseline data of each locality will be necessary to conduct such comparative studies, therefore Jamaica will strengthen its capability to work in these areas.
Genetic engineering, although a generic technology, does not produce uniform products, and blanket assurances cannot be guaranteed on safety nor spread (Brown and Vidal, 2003). So it is best to work on a case-by-case basis and compile a library of experiences to guide future actions. In such an atmosphere of uncertainty, competence in science will be premium, to allow innovation and progress to proceed without hindrance.
What is absolutely necessary is that any regulatory system contemplated for the island, must be sensitive to the varying degrees of risk and uncertainty, and the distinctive features of GM products, which may enter the island, or which may be produced locally.
In the long-term, public attitudes and the ability of the regulatory system to effectively manage risks and uncertainties, will be the key determinants of costs and benefits. In this regard, capabilities to educate consumers and sellers about GM products, will be very important.
National focal point
Jamaica has decided to make the NCST the National Focal Point to coordinate domestic activities and liase with the Biosafety Clearing House and other outside actors. The NCST can call upon the island’s pool of information specialists to discharge this function, but they must be trained to understand the new world of LMOs. They will be put in a position to use scientific information to help translate pertinent laws, regulations and standards, and assist with the implementation of the protocol. Jamaica has decided not to remain passive and allow international regulations to be agreed without it’s considered interventions.
Accordingly, studies on the socio-economic impact of the implementation of the protocol will be undertaken, and ways found to prevent implementation of the protocol from putting the island at a competitive disadvantage in the short term.
Scientific training in handling of bio-products
Scientific and technical training, in the proper and safe handling of biotechnological products in a number of relevant institutions, especially at border control points, such as customs and the coast guard, will be conducted. Also, mechanisms to ensure active private sector and community involvement in these activities will be developed. Here learning from other jurisdictions, which have experience in these endeavours, should be pursued.
In this regard capability to detect and assess promoter and marker genes, monitoring of gene flows, and the determination of the characteristics of LMOs, will be necessary. Detection, testing and quantitative analysis of LMOs therefore become indispensable.
Training of policy-makers
Since Jamaica is a trading nation, assessment of the trade impact of biosafety related measures, becomes vital. Although the island has capable legal draftsmen and women in this area of expertise, there is need for the training of policy-makers and regulators for them to fully understand the socio-economic and environmental ramifications of their decisions.
They must be put in a position to be able to balance the concerns of industry with those of the public. Reciprocal flows of information among, and between, stakeholders, are important to foster a learning environment for all concerned, especially those in the field, such as farmers and eco-tourism workers. This will help in understanding, defining and determining, what levels of risks are likely to be tolerated in the society.
The media
The news media will have the most influence on the public’s perception and understanding of biosafety matters, it is therefore incumbent that training of these professionals be undertaken to ensure a balanced message to civil society.
Discussion
All the islands of the Caribbean, irrespective of size, will have biosafety and biosafety related questions to be answered. Most will not be in a position to tackle these questions because of limited resources and capabilities. The experiences in Jamaica will therefore be instructive to decisions taken in other islands. A collective approach to biosafety makes practical sense, not only from a cost and efficacy perspective, but also from transborder biosafety considerations (Wint, 2003).
To do this, a regional biotechnology vision, leading to unified policies and strategies, has to be elaborated, so that it will be clear as to what has to be regulated and in what fashion. It must be stressed here that there are a number of gene and gene related issues that has to be handled along with biosafety concerns. These span the gamut from ethical issues of stems cells, cloning and genetic engineering, to biotechnological commercial issues, such as intellectual property and trade matters. It seems then that a Gene Technology Regulator, or Office, should be established for the Caribbean with corresponding nodes in each island. For Jamaica this could be the NCST.
For such a regional approach to be seriously considered, a detail study of the region should be done to ascertain what are the various parameters, conditions and options to be considered in crafting a collective approach.
References
Bernard, G. The National Biosafety Framework Project. National Planning Committee, Kingston, Jamaica, 2003.
Brown, P. and Vidal, J. Two GM Crops face ban for damaging wildlife. The Guardian, United Kingdom, 2003.
Fisher, E. Bioengineering in Food Production: Urgent Need for Legislation in Jamaica. Occasional Paper, Kingston, 1999.
Little, D.St.C. Review of Legislation Relevant to the Implementation of the Cartagena Protocol, NEPA, Kingston, 2003a.
Little, D.St.C. Review and Analysis of the Legal Implications of the Cartagena Protocol on Biosafety for Jamaica, NEPA, Kingston, Jamaica, 2003b.
National Environment and Planning Agency (NEPA). Towards a National Strategy and Action Plan on Biological Diversity in Jamaica, Green Paper No. 3/10, Kingston, 2001.
United Kingdom GM Science Review Panel Report. 2003. Available form Internet: www.gmsciencedebate.org.uk.
Wint, S. Environmental Regulatory Capability; Cartagena Protocol on Biosafety. Thesis – Sussex University, United Kingdom, 2003.
