Economic and Regulatory Aspects of Marine Biotechnology

Raymond A. Zilinskas

INTRODUCTION

We all know that companies will engage in research and development that they believe will benefit themselves and their clients, so there is probably not a great need for governmental intervention in the industrial or commercial aspects of marine biotechnology. However, there are other activities that benefit society as a whole but are not likely to garner support from industry. Basic research is one such activity. Others are certain environmental applications that might serve to remediate degraded or polluted environments. Those who represent industry probably would not perceive that such activities would bring economic rewards in the short term, so there the government could have an important role. I hope that together we can identify areas where governmental intervention would be valuable.

With regard to regulatory aspects, the book titled Genetically Engineered Marine Organisms: Environmental and Economic Risks and Benefits (Zilinskas and Balint 1998) focuses on the risks and benefits that would attend the release of genetically engineered organisms in the marine environment, which is not something we are likely to address in detail in this workshop. Nevertheless, I believe there are certain lessons that can be drawn from what we who contributed to the book learned while researching and writing our chapters, especially with regard to the barriers that

Monterey Institute of International Studies, Monterey, CA



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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP Economic and Regulatory Aspects of Marine Biotechnology Raymond A. Zilinskas INTRODUCTION We all know that companies will engage in research and development that they believe will benefit themselves and their clients, so there is probably not a great need for governmental intervention in the industrial or commercial aspects of marine biotechnology. However, there are other activities that benefit society as a whole but are not likely to garner support from industry. Basic research is one such activity. Others are certain environmental applications that might serve to remediate degraded or polluted environments. Those who represent industry probably would not perceive that such activities would bring economic rewards in the short term, so there the government could have an important role. I hope that together we can identify areas where governmental intervention would be valuable. With regard to regulatory aspects, the book titled Genetically Engineered Marine Organisms: Environmental and Economic Risks and Benefits (Zilinskas and Balint 1998) focuses on the risks and benefits that would attend the release of genetically engineered organisms in the marine environment, which is not something we are likely to address in detail in this workshop. Nevertheless, I believe there are certain lessons that can be drawn from what we who contributed to the book learned while researching and writing our chapters, especially with regard to the barriers that Monterey Institute of International Studies, Monterey, CA

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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP would hinder anyone who applies marine biotechnology to produce products that will be put into the seas. One barrier pertains to the performance of an adequate risk assessment before something is introduced into the seas. When we began our study, our working hypothesis was that the risk assessment procedures used in the terrestrial environment would not be adequate for the marine environment. We eventually found that this was not the case. For example, the Environmental Protection Agency (EPA) has developed 21 points that have to be dealt with adequately by a developer of a genetically engineered organism before a risk assessment is performed (EPA 1990). We eventually concluded that these so-called “21 Points to Consider” were adequate and appropriate for the marine environment also. However, the big problem was that EPA's 21 points could not be satisfied if the proposed action involved the marine environment. In particular, the so-called “familiarity” criteria could not be met. In other words, due to a lack of data, no scientist can assert that he or she is sufficiently “familiar” with the marine environment or marine organisms to be able to assess risks inherent in releasing genetically engineered organisms into the open seas (Levin 1998). Clearly, basic research in marine biology and ecology has not yet generated the fundamental data needed to undertake a risk assessment of a proposed introduction of a genetically engineered organism into the marine environment. Because an adequate risk assessment cannot currently be performed, no release of a genetically engineered organism into the marine environment for any purpose is permissible in the US. Another barrier is that a very difficult situation exists with regard to the regulatory regime dealing with marine environment. Most states have jurisdiction within 3 miles of the shoreline, although that distance is 9 miles for a few states. The federal jurisdiction is 3 to 200 miles. There is no area with joint authority. However, the regulatory situation in the marine environment within the 200-mile limit is complex because there are potentially many different authorities that would govern any proposed activity in a given area. There are some real difficulties with, for example, ascertaining whether the EPA or the US Department of Agriculture would have regulatory authority if the proposed action involved introducing organisms into the open marine environment. In the terrestrial environment, the EPA usually has authority over microorganisms introduced deliberately on or over land for a purportedly beneficial purpose, such as environmental remediation, whereas the USDA governs introduced macroorganisms, such as genetically modified plants. Whether this situation will be reflected with regard to the marine environment is not clear because neither of these agencies has expertise in the marine environment, nor

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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP has Congress made known its view on the matter. So for now, federal agencies tend to ignore the prospect of marine biotechnology applications slated for the marine environment. Surprisingly, we found the agency that apparently had the most jurisdiction in the marine environment is the US Food and Drug Administration (FDA). This is so because of the possibility that organisms and substances introduced into the seas might become food directly or could enter the food chain and thus become food eventually. FDA has gained some expertise in the marine environment because of their responsibility for seafood safety (Hazard Analysis and Critical Control Point regulations). In addition to the state/federal problem, regional groups also enter into the regulatory picture. There are, for example, regional groups contributing to regulatory actions in the Chesapeake Bay Program and the Great Lakes' International Joint Commission. These groups would certainly express their opinion if someone proposed to introduce an organism into the seas under their jurisdiction, and possibly substances as well. It can be seen that the regulatory situation in the marine environment presents a kind of legal morass, capable of entrapping unwary developers who might wish to do something in the seas under national and international jurisdiction, as well as near and on shorelines. It would appear that because so many regulations at all levels of government seek to address marine activities, there would be regulatory hurdles that would have to be overcome before any product of modern biotechnology, viable or inanimate, could be deliberately introduced into the marine environment (Stenquist 1998). I hope that in this short presentation I have made clear that as we consider the types of biotechnological research pertaining to the marine environment that federal agencies ought to support, we also give some thought not only to possible applications of such research, but also to the regulatory barriers that might prevent applications from being realized. Why would an industry develop findings from basic research if it perceived that it would face great difficulty or uncertainty when actually trying to apply products or procedures? If this were the case, it probably would move on to develop applications for use in the terrestrial environment, where the regulatory situation is known. To overcome the regulatory barrier that might prevent applications in the marine environment, government agencies should consider sponsoring research in the social sciences that would clarify what the government could do to create a regulatory regime for the marine environment that is as unambiguous and certain as the existing regulatory regime in the terrestrial environment.

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OPPORTUNITIES FOR ENVIRONMENTAL APPLICATIONS OF MARINE BIOTECHNOLOGY: PROCEEDINGS OF THE OCTOBER 5-6, 1999, WORKSHOP REFERENCES EPA [US Environmental Protection Agency]. 1990 Points to Consider in the Preparation and Submission of TSCA Premanufacture Notices for Microorganisms. Washington, DC: US Environmental Protection Agency. Levin M. 1998 Risk assessment for uncontained applications of genetically engineered organisms. In: Zilinskas RA, Balint PJ, eds. Genetically Engineered Marine Organisms: Environmental and Economic Risks and Benefits. Amsterdam: Kluwer Academic Publishers. p 1-30. Stenquist S. 1998 Federal and state regulations relevant to uncontained applications of genetically engineered marine organisms. In: Zilinskas RA, Balint PJ, eds. Genetically Engineered Marine Organisms: Environmental and Economic Risks and Benefits. Amsterdam: Kluwer Academic Publishers. p 139-180. Zilinskas RA, Balint PJ, eds. 1998 Genetically Engineered Marine Organisms: Environmental and Economic Risks and Benefits. Amsterdam: Kluwer Academic Publishers.