I. Applicability of Performance Standards
Researchers begin by determining whether or not the Performance Standards apply to the research organisms in question. If the conclusion is that they do not apply, then the researcher has completed voluntary compliance with the Standards and exits at this point. If the conclusion is that the Standards do apply, researchers should proceed to subsequent sections as directed.
Subsequent sections are designed to address organisms with a dioecious mode of reproduction because this is the most common mode among species of finfish, crustaceans, and molluscs. In cases of research involving organisms with non-dioecious modes of reproduction, researchers are asked to assess the organisms so that specific guidance can be recommended. Two non-dioecious forms, self-fertilizing hermaphrodites and true parthenogens, can establish an entire population from one accidental escapee. Researchers working with such organisms will also perform this assessment.
Regarding finfish, all subsequent sections and the Assessment of Non-dioecious Organisms apply both to non-bearers and bearers (see glossary definition for bearers). If the proposed project involves a bearing species, particularly an internal bearer, users should keep in mind the following issue when answering questions on all subsequent sections. Escape of a single, bearing adult fish could result in eventual release of an entire brood of progeny from the one adult, thus increasing the possibility of establishing an entire population of genetically modified descendants.
Applicable Organisms
Genetic modification may alter attributes of the organism that affect its interaction with its environment or create new attributes that affect its safety as addressed by questions in the Standards. Any proposal to create or use genetically modified aquatic organisms should characterize: the method of genetic modification; the molecular characterization (where possible) and stability of the modification; and the expression, functions, and effects of the genetic modifications. Although the process of modification alone is not a determinant of risk or safety, such information can facilitate a determination of whether the modification decreases, increases, or has no effect on environmental safety.