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