Regulations Under the
Financial support: OAS Project number AE 145-01 "Biosafety Regulations in
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.
small country, like
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.
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.
These facts have lead to a deep commitment to protect the nationís biodiversity and maintain its natural beauty. Achieving satisfactory levels of biosafety is therefore top of the islandís priorities.
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 islandís 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.
Biotechnology Centre was established at the University of the
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
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
is needed in
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).†
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.†
is interesting to note that
∑ 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.
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.
are many gaps in the various legislations 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.
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:
ō food safety and human health;
ō plant and animal quarantine;
ō pesticide and herbicide use;
ō invasive species;
ō endangered species;
ō measurement of hazardous materials; and
ō research and development and social intelligence in all these areas.
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 islandís 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
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.
for even greater safety, additional research, especially epidemiological
surveillance, may be necessary.
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
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
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
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
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 news media will have the most influence on the publicís 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.
the islands of the
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
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.
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