Policy Considerations for Advancing Marine Biotechnology

Lori Denno

As the science of marine biotechnology advances, policy issues relating to resource access and management are emerging that may potentially affect the development of the field. With the support of the National Sea Grant College Program, the Center for the Study of Marine Policy at the University of Delaware has been involved in a 3-year study to research these issues. This research will be summarized in the Center's forthcoming book titled Policy Issues in the Development of Marine Biotechnology(Cicin-Sain and others 2000), which will contain components such as surveys of industry scientists and company representatives, evaluation of both the national and international policy frameworks that affect marine biotechnology, ways to structure relationships between industry and government to advance the field, and evaluation of public perceptions of the industry and biotechnology products.

Two basic questions trigger the policy context for marine biotechnology:

Where will the natural resources come from that will be used as models, studied, and developed? and

Where and how will these products be field-tested?

The first question relates to frameworks for marine resource access and management, and the second to emerging protocols for biosafety.

National Resources Conservation, Delaware Nature Society, Hockessin, DE



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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP Policy Considerations for Advancing Marine Biotechnology Lori Denno As the science of marine biotechnology advances, policy issues relating to resource access and management are emerging that may potentially affect the development of the field. With the support of the National Sea Grant College Program, the Center for the Study of Marine Policy at the University of Delaware has been involved in a 3-year study to research these issues. This research will be summarized in the Center's forthcoming book titled Policy Issues in the Development of Marine Biotechnology(Cicin-Sain and others 2000), which will contain components such as surveys of industry scientists and company representatives, evaluation of both the national and international policy frameworks that affect marine biotechnology, ways to structure relationships between industry and government to advance the field, and evaluation of public perceptions of the industry and biotechnology products. Two basic questions trigger the policy context for marine biotechnology: Where will the natural resources come from that will be used as models, studied, and developed? and Where and how will these products be field-tested? The first question relates to frameworks for marine resource access and management, and the second to emerging protocols for biosafety. National Resources Conservation, Delaware Nature Society, Hockessin, DE

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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP POLICY FRAMEWORK GOVERNING THE OCEANSAND MARINE RESOURCES In the last few years, two important conventions have catalyzed the need for examination of relationships between marine resource management and the marine biotechnology industry: the Convention on Biological Diversity and the United Nations Convention on the Law of the Sea. Convention on Biological Diversity The Convention on Biological Diversity, often referred to as the Biodiversity Convention, was opened for signature in the course of the United Nations Conference on Environment and Development and entered into force on December 29, 1993, and remains without US Congressional ratification. The primary objectives of the Convention are “the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies ” (UNCED 1993, p. 2). Measures to accomplish these objectives include the following: identifying and monitoring the components of biological diversity; providing for in situ biological diversity conservation through the establishment and maintenance of protected area systems; adopting economic measures that act as incentives for the conservation and sustainable use of biological diversity; increasing the emphasis on research and training and scientific and technical cooperation; and promoting public education and awareness regarding biological diversity (UNCED 1993, p. 2). The need to link conservation and development of biodiversity as a key to ensuring incentives for conservation while expanding economic benefits is a primary focus of the Biodiversity Convention. It has broken new ground in international norms governing access to genetic resources by articulating the concept of regulating access to genetic resources to harness market incentives for the conservation of genetic information. In Article 15, Access to Genetic Resources, the Convention explicitly states that nations have sovereignty over their own genetic resources: “Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation ” (UNCED 1993, p. 8). The Biodiversity Convention laid the groundwork for the establishment of national systems governing genetic resources. National rights may now be formally tied to genetic resources through regulations governing resource access.

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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP United Nations Convention on the Law of the Sea The Biodiversity Convention does not specifically address issues of access to marine genetic resources. However, the concept of sovereign rights over genetic resources in the marine environment is put forth in the United Nations Convention on the Law of the Sea (UNCLOS). Often referred to as a “constitution for the oceans,” UNCLOS represents the culmination of 14 years of international negotiation to formulate and articulate rules to govern ocean space. Entered into force on November 16, 1994, UNCLOS delimits national ocean jurisdictions and sets forth rules governing the majority of ocean uses. Part V of UNCLOS asserts that coastal nations party to the Convention may establish their own Exclusive Economic Zone (EEZ). The EEZ may extend up to 200 nautical miles from designated baselines. Within the EEZ, the coastal nation has sovereign rights over exploration, exploitation, management, and conservation of living and nonliving resources. Conservation of living marine resources and protection of the marine environment are recurring themes throughout UNCLOS. This Convention supports the rights of nations to utilize and exploit marine resources within national waters; nonetheless, it also calls for “necessary measures” to ensure the ecological balance of the marine environment, both in areas under national jurisdiction and on the high seas (Vargas 1997). Article 246, Section 3, stipulates that coastal States should grant consent for other States to carry out marine scientific research for the purpose of increasing scientific knowledge to benefit all mankind. Section 5, part A, however, specifically acknowledges that coastal States may withhold consent to the conduct of marine scientific research if the research “is of direct significance for the exploration and exploitation of natural resources ” (UNCLOS 1983, p. 87). ACCESS TO MARINE RESOURCES IN NATIONAL WATERS UNCLOS and the Biodiversity Convention together provide an international framework for access to marine genetic resources. Through these agreements, nations have sovereignty over marine resources out to 200 nautical miles, as well as the authority to determine conditions of access to biological and genetic resources that may ultimately possess commercial value. Some companies have chosen to enter into benefit-sharing agreements with a host country or entity. In September 1991, Costa Rica's National Biodiversity Institute (INBio) announced an agreement with Merck & Co., Ltd., a US pharmaceutical firm, under which INBio agreed to provide Merck with chemical extracts from Costa Rica's conserved wildlands for

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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP Merck's drug screening program in return for a two-year research and sampling budget and royalties on any resulting commercial products. INBio also agreed to contribute 10% of the budget and 50% of any royalties to the government's National Park Fund for the conservation of national parks in Costa Rica, and Merck agreed to provide technical assistance and training (Reid 1993). The agreement has been renewed twice for 2-year increments—in July 1994 and August 1996 (Vargas 1997). In August 1997, Yellowstone National Park entered into a bioprospecting agreement with Diversa, Inc. Facilitated by the World Foundation for Environment and Development, it is the first agreement of its kind in the United States. Under the terms of the agreement, Diversa, a company specializing in discovery and application of enzymes, will conduct research to evaluate the bioactivity of thermophilic organisms found in Yellowstone. In return, Diversa will provide Yellowstone with an upfont payment of $100,000 over 5 years and a percentage of revenues generated by any products developed from research on samples taken from the Park (J. D. Varley, Yellowstone Center for Resources, personal communication, October 28, 1997). To date, the use of such agreements in the marine environment has been limited, and marine resource collection is generally treated under UNCLOS provisions relating to marine scientific research. As new frameworks are developed, however, it is feasible that a coastal State could pass legislation stipulating conditions of access to its marine resources throughout the Exclusive Economic Zone. Highlighted as central to the Convention on Biological Diversity, such provisions might include technology transfer, recognition of indigenous knowledge, and benefit-sharing requirements. ACCESS TO MARINE RESOURCES IN INTERNATIONAL WATERS The Convention on Biological Diversity does not directly address biological resources in international waters but states that its Parties have a duty to cooperate in areas beyond national jurisdiction (UNCED 1993, p. 5). Currently, the primary governing mechanism in international waters is the International Seabed Authority, negotiated under the UNCLOS at a time when the mineral resources of the deep seabed were thought to have great economic potential. Due to their location, these resources were viewed as the “common heritage of mankind.” The International Seabed Authority was thus created to ensure the equitable distribution of any benefits arising from mining operations. With the exception of certain fishing agreements, most other activities on the high seas are generally governed under the Freedom of the Seas regime, which supports unrestricted access to and use of ocean resources.

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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP It is unclear which, if any, UNCLOS provisions may govern activities related to marine biotechnology. If the activity is viewed as “bioprospecting, ” it could be interpreted as a mining activity governed by the International Seabed Authority. If, however, it is interpreted as scientific research, as is typically the case to date, or as resource collection activity, such as fishing, then other policies will provide the access framework. This policy question is as yet unresolved, and it is worth noting that suggestions have been made for the creation of protected area networks on the high seas to protect the hydrothermal vent communities and other areas of high biological significance. Deep sea hydrothermal vents, home to many potentially industrially valuable microorganisms, exist not only in national waters, but also in areas where national jurisdiction is not clearly established, either because of conflicting claims or because the area is beyond national jurisdiction and falls within the purview of common heritage of mankind. Although access to resources in these areas is currently dependent on the availability of deep-sea technologies, it could, in the future, depending on the location of the vent area, be subject to Coastal State regulation by the Coastal State or by an international governing authority. ISSUES OF BIOSAFETY The Convention on Biological Diversity establishes the policy framework for biosafety issues. Addressed in the Convention, biosafety is the safe transfer, handling, and use of any living modified organisms (LMOs) resulting from biotechnology (UNCED 1993, p. 19.3). Moreover, the Convention calls for Parties to: “establish or maintain means to regulate, manage, or control the risks associated with the use and release of LMOs resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risk to human health.” (UNCED 1993, p. 11). Key issues revolve around the lack of knowledge between how LMOs may interact with their environment, including competition with other species and their impact on nontargeted species in the ecosystem. Additionally, the perception exists that developing countries may be used as testing grounds for the release of LMOs. The Biosafety Working Group was created under the auspices of the Convention in November 1995 to clarify and resolve these issues. Negotiations are still ongoing, but if and when a biosafety protocol is developed, it will likely contain provisions regarding transboundary movement of LMOs: advance informed agreement, risk assessment, and

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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP management; capacity building; information exchange; reporting and compliance; issues of liability and compensation; and socioeconomic considerations. Although enforcement of biosafety provisions may be challenging, such policies may be instrumental in cultivating public acceptance of biotechnology products and providing the clear regulatory frameworks for biotechnology firms that are necessary for sound investment strategies. PUBLIC PERCEPTIONS OF BIOTECHNOLOGY Another issue of relevance to the US marine biotechnology industry is public perception of the industry and its products. To date, much public interaction with biotechnology has taken place in a negative context. The most notable clashes between the public and the biotechnology industry have involved concerns voiced regarding field testing of genetically engineered microbial pesticides, levels of bovine growth hormone in dairy products, and genetically engineered agricultural products. It may be, however, that these concerns arose from perceived levels of risk resulting from a lack of scientific understanding or from inadequate communication between the industry and the public sector (Fleising 1991). Benefits to society resulting from biotechnological processes are rarely as well publicized as the risks. For example, the public has virtually no way of differentiating a biotechnologically derived pharmaceutical product from one that has been manufactured through other methods. Yet, it is likely that few individuals would decline an important medical treatment based on its origin. Public perception has the potential to affect the development of the industry. In a survey conducted by the Center for the Study of Marine Policy, 65% of industry representatives reported that ethical issues and related public perceptions could affect development of the field (Cicin-Sain and others, Forthcoming). Opportunities for increased public awareness include outreach associated with benefit-sharing agreements, such as the Merck-InBio partnership. Such partnerships can serve as a vehicle to highlight important uses and applications of marine biotechnology and to demonstrate partnerships that meet both goals of economic development and conservation and sustainable resource use. Additionally, educational venues—schools and learning centers, such as science centers and aquariums—could provide platforms to teach the public about biotechnology and its contributions to sustainable resource use and the protection of human health. In summary, both policy issues and social perspectives may affect the advancement of the marine biotechnology industry. Additional research is needed to help in further articulating some of the policy frameworks

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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP that govern access to marine resources and field testing of new products and processes and to provide additional insight regarding public response to and reception of new biotechnology products and processes. REFERENCES Cicin-Sain B. Knecht RW, Jang D, eds. 2000 Policy Issues in the Development of Marine Biotechnology. Newark, DE: University of Delaware Center for the Study of Marine Policy. (Forthcoming). Fleising U. 1991 Public perceptions of biotechnology. In: Moses V, Cape RE, eds. Biotechnology: The Science and the Business 93. New York: Hardwood Academic Publishers. Reid WV. 1993. Biodiversity Prospecting: Using Genetic Resources for Sustainable Development. Washington, DC: World Resources Institute. UNCED [United Nations Conference on Environment and Development]. 1993 Convention on Biological Diversity. New York: United Nations Department of Public Information. UNCLOS [United Nations Convention on the Law of the Sea]. 1983 The Law of the Sea with Index and Final Act of the Third United Nations Conference on the Law of the Sea. New York: United Nations Department of Public Information. Vargas E. 1997 Summary of Terms for the INBio-Merck & Col., Inc. Collaboration Agreement. <Evargas@quercus.inbio.ac.cr>.