Abstract
This paper provides an overview of the U.S. regulatory framework governing genetic biocontrol efforts for invasive fish. Genetic biocontrol refers to the intentional release of genetically modified organisms (GMOs) into the environment to control a target population of a non-native species. The terms “genetically modified” and “genetically engineered” are often used interchangeably, despite the scientific distinctions. A GMO is an organism that has had its genetic material altered or modified by humans through any method, including conventional breeding. Genetic engineering, as defined by the Food and Drug Administration (FDA), is the use of recombinant DNA techniques to introduce new characteristics or traits into an organism. GE organisms are therefore a subset of GMOs. As this paper will discuss, existing laws focus on GE organisms raising significant questions as to whether organisms modified without utilizing rDNA techniques fall within the jurisdiction of any federal agency. Under the 1986 Coordinated Framework for Regulation of Biotechnology, three federal agencies have primary responsibility over biotechnology—the Environmental Protection Agency (EPA), the U.S. Department of Agriculture, and the FDA. Because the EPA has exempted biological control agents from regulation as pesticides and no fish species are currently considered plant pests, the FDA is the agency responsible for approving the use of genetically engineered fish for biocontrol. FDA regulates genetically engineered animals through its New Animal Drug Application (NADA) process. The NADA process presents several challenges to effective and transparent regulation of genetic biocontrol, including the FDA’s focus on drug safety, secrecy provisions potentially limiting disclosure of the results of environmental reviews, and the secondary role of the Fish and Wildlife Service, the federal agency with the most experience with invasive species management. In addition, relying on the NADA process creates a significant regulatory gap as NADA approval is only required for GE organisms. The regulatory framework for GMOs created for genetic biocontrol without rDNA technology is unclear and primary responsibility may fall to the states. Given its extensive experience with hatcheries, invasive fish species control, and environmental reviews, the Fish and Wildlife Service (FWS) is the more appropriate agency to review applications for genetic biocontrol. Efforts should be undertaken now, while genetic biocontrol is still in the theoretical stages, to increase the role of the FWS in the permitting process either through formal regulations or more informal mechanisms such as memorandum of understanding.
Similar content being viewed by others
References
Aqua Bounty Technologies (2006) Aqua Bounty successfully completes key study for Aquadvantage salmon FDA accelerates review process
Baumhover AH et al (1955) Screw worm control through the release of sterilized flies. J Econ Entomol 48:462–466
Chick JH, Pegg MA (2001) Invasive carp in the Mississippi River basin. Science 292(5525):2250–2251
Conservation Genetics Community of Practice, U.S. Department of Interior (2010) Letter re: VMAC briefing packet for AquAdvantage salmon
Council on Environmental Quality, Executive Office of the President (2010) Memorandum for Heads of Federal Departments and Agencies: establishing, applying and revising categorical exclusions under the National Environmental Policy Act
Devlin RH et al (2007) Assessing ecological effects of transgenic fish prior to entry into nature. In: Kapuscinshi AR et al (eds) Environmental risk assessment of genetically modified organisms, vol 3. CAB International, UK, pp 151–187
Food and Drug Administration (2003) FDA Statement Regarding Glofish. http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm161437.html. Accessed 19 Aug 2010
Food and Drug Administration (2009) Guidance for industry: the regulation of genetically engineered animals containing heritable rDNA constructs, CVM GFI # 187
Food and Drug Administration (2010a) AquAdvantage salmon VMAC briefing packet
Food and Drug Administration (2010b) Charter of the Veterinary Medicine Advisory Committee. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm123835.html. Accessed 19 Oct 2011
Gutierrez J, Teem J (2006) A model describing the effect of sex-reversed YY fish in an established wild population: the use of a Trojan Y chromosome to cause extinction of an introduced exotic species. J Theor Biol 241:333–341
Kapuscinski AR, Patronski TJ (2005) Genetic methods for biological control of non-native fish in the Gila River Basin. Contract report to the U.S. Fish and Wildlife Service, University of Minnesota, Institute for Social, Economic and Ecological Sustainability, St. Paul, Minnesota. Minnesota Sea Grant Publication F 20. http://www.seagrant.umn.edu/downloads/f20.pdf
NOAA Fisheries (2011) Fact sheet: the Endangered Species Act—protecting marine resources
Office of Science and Technology Policy (2001) Case Study No. I: growth-enhanced Salmon, CEQ/OSTP assessment: case studies of environmental regulations for biotechnology
Osvath R (2001) Review of bioengineered salmon moves forward. Food Chemical News 43:13
Pimentel D, Zuniga R, Morrison D (2005) Update on the environmental and economic costs associated with alien–invasive species in the United States. Ecol Econ 52:273–288
Smith MD et al (2010) Genetically modified salmon and full impact assessment. Science 330:1052–1053
Thresher R, Bax N (2003) The science of producing daughterless technology; possibilities for population control using daughterless technology; maximizing the impact of Carp control. In: Lapidge K (ed) Proceedings of the national carp control workshop, 5–6 March. Cooperative Research Centre for Pest Animal Control, Canberra, Canberra, pp 19–24
Twohey M (2000) The sterile-male release technique in Great Lakes sea lamprey management. J Great Lakes Res 29(Supplement 1):410–423
Acknowledgments
Research for this article was made possible through funding for the National Sea Grant Law Center under award number NA09OAR4170200 from the National Oceanic and Atmospheric Administration, U.S. Department of Commerce. The statements, findings, conclusions, and recommendations are those of the author and do not necessarily reflect the views of NOAA or the U.S. Department of Commerce.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Otts, S.S. U.S. regulatory framework for genetic biocontrol of invasive fish. Biol Invasions 16, 1289–1298 (2014). https://doi.org/10.1007/s10530-012-0327-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10530-012-0327-5