Risk assessment and risk management of transgenic fish

Several governments have addressed the issue of research on fish, but many have not addressed transgenic fish directly. The U.S.D.A. developed guidelines (standards) for research on genetically modified fish and shellfish (US ABRAC 1995). In Europe, legislation and guidance is addressed in Directive 2001/18/EC which is implemented by Member States. An example is the U.K Statutory Instrument 2002 #2443 (2002) on release of GM animals. The UK Advisory Committee on Release to the Environment (ACRE) also issued a guidance note on releases to the environment of transgenic fish. In the Canadian regulatory system the Canadian Environmental Protection Act addresses regulation of any animal that is not contained, including transgenic fish. In general the approach to risk management has been through containment.

Mechanisms employed to prevent potential adverse effects to the environment include mechanical containment systems and/or biocontainment such as those reviewed in Devlin and Donaldson 1992. Closed water systems have been used in research on transgenic fish to ensure no escape into the environment as utilized by Rahman et al (2001). The most commonly used biocontainment method is through heat or pressure shock sterilization for induction of triploidy (Benfey 1999). Induction of triploidy is not 100% effective, nor is it commercially feasible for all species. Triploidy also has effects on the reducing fish growth (Devlin et al 2004). Transgenic sterilization is also a potential mechanism. (Dunham 2004, MacLean et al 2002)).

Potential environmental risks of living modified fish species has been addressed in several recent reviews (Devlin et al. 2006; MacLean et al, Biosafety Reviews 2: 36-65 2005, Muir and Howard, Transgenic Research 11: 101-114 2002), USDA, ABRAC Performance standards for genetically modified fish, 1995), (Royal Society UK, The use of GM organisms, May 2001), (US Congressional Research Services July 2005 Genetically engineered Fish and seafood., U.S. National Research Council 2004 Animal Biotechnology Science Based Concerns, National Academies Press). The US NRC indicates that transgenic fish pose the “greatest science based concerns associated with animal biotechnology in large part due to the uncertainty inherent in conducting predictive risk assessments and the difficulty of remediation”.

Most recently (September 18, 2008) the US Food and Drug Administration (FDA) released a draft guidance document for genetically engineered animals (available here: http://www.fda.gov/cvm/GEAnimals.htm).