Journal of Environmental and Sustainability Law Missouri Environmental Law and Policy Review Volume 17 Article 4 Issue 1 Fall 2009 2009 Genetically Modified Insects: Why Do eW Need Them and How Will They Be Regulated? Michael J. Donovan Follow this and additional works at: https://scholarship.law.missouri.edu/jesl Part of the Environmental Law Commons Recommended Citation Michael J. Donovan, Genetically Modified Insects: Why Do eW Need Them and How Will They Be Regulated?, 17 Mo. Envtl. L. & Pol'y Rev. 62 (2009) Available at: https://scholarship.law.missouri.edu/jesl/vol17/iss1/4 This Comment is brought to you for free and open access by the Law Journals at University of Missouri School of Law Scholarship Repository. It has been accepted for inclusion in Journal of Environmental and Sustainability Law by an authorized editor of University of Missouri School of Law Scholarship Repository. For more information, please contact [email protected]. Genetically Modified Insects: Why Do We Need Them and How Will They be Regulated? Michael J. Donovan, Ph.D. J.D. Candidate, Sandra Day O'Connor College of Law, Arizona State University; Ph.D., Biology specializing in Immunology and Parasitology, 2007, University of Notre Dame; B.S., Microbiology, 2001, University of Michigan. Mo. ENVTL. L. & POL'Y REV., Vol. 17, No. 1 TABLE OF CONTENTS Introduction.....................................................64 I. The Science of and Public Response to GM Insects........................68 A. Motivations for GM Insects......................................68 1. Human Health.............................................68 2. Agricultural Concerns.......................................73 3. Other Potential Motivations for the Development of GM Insects...............................................75 B. How to Make a GM Insect.......................................75 1. Direct Genome Modification................................... 76 a.SIT.................................................. 76 b. Genetic Manipulation..................................... 77 2. Paratransgenesis............................................ 79 C. The Possible Drawbacks to GM Insects.............................80 1. Direct Impacts on Human Health ................................................... 80 2. Environmental Impacts....................................... 81 D. The Public's View............................................ 82 1. Pro GM Insects ....................................................................... 82 2. Anti-GM Insects...................................................................... 83 E. The Potential Impacts - Surrogate Models ...................... ..... 85 1. The Cactus M oth ................. .......................... .......................... 85 2. "Africanized" Honeybees ..................................... 86 RegulationC. of GM Insects ......................................... 87 A. Coordinated Framework ................................................................ 87 B. Food and Drug Administration......................................................... 89 1. Regulatory Jurisdiction ....................................... 90 2. FDA's Regulatory Process .......................................................... 92 C. Environmental Protection Agency.................................94 1. Regulatory Jurisdiction ....................................... 95 a. FIFRA............................................................................. 95 b. TSCA.............................................................................. 96 2. EPA's Regulatory Process.....................................97 a. FIFRA............................................................................. 97 b. TSCA.............................................................................. 98 D. U.S. Department of Agriculture ........................................................ 99 1. USDA's Jurisdiction ................................................................ 100 a. Plant Protection Act ..................................... 100 b. Animal Health Protection Act...............................102 c. Honeybee Act..........................................102 2. USDA's Regulatory Process .................................. 103 E. International Regulations.......................................105 Conclusion.................................. ..................... 107 63 GENETICALLY MODIFIED INSECTS INTRODUCTION The biotechnology' age began in 1973 with the publication of a research paper by Cohen and Boyer detailing their experiments in which they created a functional bacterial plasmid in vitro.2 This initial report explained how to splice two different DNA strands together and create an entirely new and functional DNA molecule. This development, although ground-breaking, immediately raised questions about the risks involved with the application of this technology. In a letter to Science the following year, several Nobel prize-winning scientists voiced their concerns over recombinant DNA (hereinafter "rDNA") technology.3 The group, including James Watson, proposed a moratorium on research using rDNA technology until a general meeting of scientists could be held. This proposed meeting was held in Asilomar, California in 1975. The output of the Asilomar conference was a set of conclusions about the potential uses of rDNA and recommendations for its regulation and safe use.5 The regulation of rDNA technology evolved from its beginnings in Asilomar. The Asilomar conference's non-binding recommendations were later used as the basis for the National Institutes of Health's (hereinafter "NIH") rDNA mandatory safety requirements. 6 The NIH's mandatory guidelines, however, applied only to research groups using 1Biotechnology, broadly defined as "the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services," ALAN T. BULL ET AL., ORG. FOR ECON. CO-OPERATION & DEV., BIOTECHNOLOGY: INTERNATIONAL TRENDS AND PERSPECTIVES 18 (1982) (internal quotation marks omitted), available at http://www.oecd.org/dataoecd/34/9/2097562.pdf, has technically been around for centuries. The use of yeast to make beer and wine is technically a use of biotechnology. The advent of recombinant DNA technology has allowed scientists to manipulate organisms used in providing goods and services, leading to what many have come to think of as modem-day biotechnology. 2See Stanley N. Cohen et al., Construction ofBiologically FunctionalBacterial Plasmids In Vitro, 70 PROc. NAT'L ACAD. SCI. 3240 (1973). 3 See Paul Berg et al., PotentialBiohazards ofRecombinant DNA Molecules, 185 SCI. 303 (1974). 5 See Paul Berg et al., Summary Statement of the Asilomar Conference on Recombinant DNA Molecules, 72 PROC. NAT'L ACAD. SCI. 1981, 1981-83 (1975). 6 Recombinant DNA Research, 41 Fed. Reg. 27,902, 27,902 (July 7, 1976). 64 Mo. ENVTL. L. & POL'Y REv., Vol. 17, No. 1 federal funds.7 Any groups with independent means were free to take these rules under advisement but were not required to comply. Then, in 1986, the United States federal government published its own regulations in the Federal Register. These regulations, the CoordinatedFramework for Regulation of Biotechnology (hereinafter "Coordinated Framework"), have remained the basis of biotechnology regulation.8 The Coordinated Framework uses the joint efforts of three federal agencies, the Food and Drug Administration (hereinafter "FDA"), the Environmental Protection Agency (hereinafter "EPA"), and the United States Department of Agriculture (hereinafter "USDA"), to regulate biotechnology. Since the 1980s, the use of biotechnology has been both successful and controversial. Early on, many developments were not controversial as researchers were able to create plants that were resistant to a variety of chemicals. 9 In 1987, five applications for field trials of genetically modified (hereinafter "GM") plants were approved, and since that date, more than 12,000 field trials have been approved by government agencies. 0 More controversial, the 1980s also saw the creation of GM microorganisms for biotechnology uses." Researchers in California created a strain of Pseudomonas fluorescens that incorporated a gene, which when expressed, produced an anti-freeze protein that delayed ice crystal formation.12 This organism was named the "ice-minus" strain.'3 The creators of this organism were interested in its potential agricultural applications for use in preventing frost damage to plants during the fall growing season.14 To test its potential viability as a biotechnology product, field tests were necessary. The creators applied for regulatory ' See id 8 See Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (June 26, 1986). 9 Alan McHughen & Stuart Smyth, US Regulatory System for Genetically Modified [Genetically Modified Organism (GMO), rDNA or Transgenic] Crop Cultivars,6 PLANT BIOTECHNOLOGY J. 2, 4 (2008). '0 Id. at 5. "1See Jean L. Marx, Assessing the Risks ofMicrobialRelease, 237 ScI. 1413 (1987). 12 Id. at 1413-14. " Id. at 1413. 14 d 65 GENETICALLY MODIFIED INSECTS approval of field tests; and after two years of delay, their applications were approved.15 Unfortunately, public sentiment was not on their side.16 Opposition to the field trials was strong enough to further delay the testing.' 7 Eventually, the field tests were moved to a new location, approved, and completed, although the product eventually proved not to be commercially viable.'8 Applications