Rethinking Risks: Should Socioeconomic and Ethical Considerations Be Incorporated into the Regulation of Genetically Modified Crops?
Du, Dorothy, Harvard Journal of Law & Technology
TABLE OF CONTENTS I. INTRODUCTION II. "NON-SCIENTIFIC" CONCERNS OVER GM CROPS A. Moral and Religious Objections to Genetic Engineering B. Contamination and Coexistence C. Consumer Choice and Labeling D. Patent Litigation and Corporatization of the Food Supply E. Rise of Monocultures and Effects on Biodiversity in the Food Supply III. REASONS FOR INCORPORATING NON-SCIENTIFIC CONCERNS INTO THE REGULATORY PROCESS A. Non-scientific Considerations Are Already Driving GM Policy Implicitly and Non-transparently, Creating Problems with Accountability and Expertise B. Incorporation of Non-scientific Concerns Would Create Opportunities for Greater Public Participation, Strengthening Public Trust in GMOs and GMO Regulation IV. ARGUMENTS AGAINST INCORPORATION INTO THE REGULATORY PROCESS A. Incorporation of Socioeconomic and Ethical Concerns into GMO Regulation May Be Incompatible with International Trade Laws 1. Agreement on the Application of Sanitary and Phytosanitary Measures 2. Cartagena Protocol on Biosafety B. Integrating Non-scientific Factors into GMO Regulation Could Adulterate Scientific Determinations in the Pursuit of "Political Correctness" C. The Opportunity Cost of Integration: The Potential for Depriving Farmers, Consumers, and Biotech Companies of GM Technology V. CONCLUSION
This Note surveys a range of non-scientific concerns associated with transgenic or genetically modified ("GM") crops and argues for their incorporation into the regulatory process. A number of scholarly articles have critiqued the regulatory process for genetically modified organisms ("GMOs"), but none has systematically examined whether the relevant agencies are taking into account all the factors that they ought to consider in regulating GM crops. (1) This Note attempts to fill that gap. Building on Gary Marchant's recognition of the need to incorporate social and ethical issues into the regulation of emerging technologies, (2) this Note applies Marchant's insights to GMO regulation. Non-scientific concerns relate broadly to public participation in GMO regulation and to the overall utility of genetic engineering. Many who share these concerns reject product-based regulation of GMOs and assign paramount importance to the processes involved in the creation of GMO products. (3)
Transgenic or genetically modified crops are crops whose genetic codes have been directly altered by insertions, deletions, or other modifications of DNA in the laboratory. (4) The commercialization of GM crops has grown tremendously since their introduction in 1996. (5) By 2012, 93% of soybeans, 94% of cotton, and 88% of corn grown in the United States was transgenic. (6) Nevertheless, the modern U.S. regulatory scheme for GMOs derives from the Coordinated Framework for Regulation of Biotechnology ("Framework"), a policy document issued in 1986 by the Reagan administration's Office of Science and Technology Policy ("OSTP"). (7) Regulatory policy has changed little since the adoption of the Framework. (8)
Multiple scholars have noted that the principles set forth in the Framework seem to presume biotechnology's relative safety and utility. (9) First, the Framework is based on "a determination that the process of biotechnology [is] not inherently risky." (10) GMo regulation is "product-based"; the Framework regulates only the products of biotechnology rather than the process of producing them. (11) Accordingly, the FDA has adopted the substantial equivalence doctrine, which states that GM products that are "substantially equivalent" in biochemical composition to their non-GM counterparts should be regulated in the same way as their conventional counterparts. (12) under this doctrine, if a non-GM counterpart is "generally recognized as safe" ("GRAS"), then the GM product is typically considered to be GRAS. …