WEIRD SCIENCE: FRANKENSTEIN FOODS AND STATES AS LABORATORIES OF DEMOCRACY.

• Author: McGee, Jennifer

1. INTRODUCTION 112 II. A BRIEF HISTORY OF GMO LABELING IN THE UNITED STATES 117 A. In the Beginning 117 B. Recent Developments 122 III. TO LABEL OR NOT TO LABEL? 128 A. Making Sense of the GMO Conflict 128 B. Consumer Protection and Private Industry 137 IV. VERMONT'S ACT 120 VS. THE NATIONAL STANDARD 140 A. "Produced with Genetic Engineering" vs. QR Code 140 B. Foods Produced with Genetic Engineering vs. Foods Containing GMOs 141 C. State Labeling Requirements vs. Federal Preemption 143 V. CONCLUSION 147 Appendix A: Sample Ohio Statute 149 Appendix B: Act 120 vs. The National Standard 153 Appendix C: Additional Labeling 155 I. INTRODUCTION

   Imagine implanting fish genes into strawberries and tomatoes to protect their fruit from freezing, or injecting bacteria into corn so the plant kills and wards off insects. Imagine injecting synthetic growth hormones into salmon so that they can grow larger, or into dairy cows so that they can produce more milk. This isn't science-fiction. (1) These techniques, and others like them, are already being used across the United States. (2) Genetic engineering involves combining two unrelated species that could not reproduce in nature and uses complex techniques to combine their genes forcefully. (3) What could go wrong?

   The truth is that no one really knows. (4) Jurassic Park, a science-fiction novel written by Michael Crichton, is a cautionary tale of the unconsidered broader consequences of biological tampering and so called "playing god." (5) In the novel, an entrepreneur uses advanced biological engineering techniques to breed extinct plants and animals in a laboratory. (6) For those who have not had the pleasure of reading the novel--spoiler alert--it doesn't end well! The scientists fail to consider the broader consequences of fusing modern amphibian DNA with prehistoric dinosaur DNA and lose control of their biological experiment. (7)

   Similar to the entrepreneur of Jurassic Park, the United States eagerly jumped aboard the metaphoric GMO-train. (8) Proponents of genetically modified organisms ("GMOs") say that scientific evidence proves that the technology is safe and GMO products are substantially the same as non-GMO products, although, one could effectively argue that it is too soon, if even possible, to determine that fact definitively. (9) The federal government takes a proactive approach, relying on industry data to determine that GMOs are safe, however, there have been several instances throughout history when the national government has been criticized for failing to consider the broader, long-term effects of proposed legislation and scientific studies. (10)

   In the 1940s, the federal government deemed pesticides such as DDT (11) safe for wide-spread commercial use and even coined it a "miracle chemical." (12) Twenty years later, States were only able to ban the substance once legislators proved the harmful side effects to fish and bird populations caused by water contamination. (13) In the 1990s, the Federal government approved injecting rBST (14) into dairy cows to increase milk production. (15) Conflicting evidence has recently surfaced, however, showing that its use increases the amount of antibiotics present in the foods Americans consume. (16)

   The key difference between these techniques and modifying DNA is that farmers are able to stop using these methods once any dangers are discovered. (17) Altering species' DNA is different because GMO plants are able to produce seeds that cross pollinate with other non-GMO plant varieties. (18) Once these genetically engineered ("GE") plants are introduced into the environment, it would be all but impossible to eradicate them completely. (19) Farmers can stop spraying their plants or stop injecting their cows (20) ; however, realistically, they cannot prevent pollination, making cross-pollination inevitable. (21)

   Due to concerns like these and many others, a majority of Americans support GMO disclosure. (22) After the federal government refused to mandate GMO labeling on a national level, (23) several States reacted by passing their own legislation. (24) The State laws were in large part a response to conflicting scientific reports that suggest that GMOs may not be as safe as their proponents argue. (25) To counter these local legislation efforts, lobbyists pressured legislators at the federal level to pass a law prohibiting State labeling requirements. (26) Most recently, this was in the form of the National Bioengineered Food Disclosure Standard ("the National Standard") which was signed into law July 29, 2016. (27)

   This Article analyzes the National Standard and posits that Vermont's Act 120 was a more effective labeling law because it safeguarded consumer sovereignty. The State regulatory scheme in place prior to the passage of the National Standard satisfied consumer demand for disclosure while allowing for necessary experimentation with GMO labeling. Part I provides an overview of the current federal scheme regulating GMOs. Part II analyzes of the conflict surrounding GMOs and labeling. Given that analysis, Part III compares the disclosure requirement of the National Standard with the requirements of Vermont's Act 120 and concludes that Vermont's labeling law offered a better safeguard for consumer sovereignty because it included a larger range of products and required a label that immediately relayed disclosures to consumers.

2. A BRIEF HISTORY OF GMO LABELING IN THE UNITED STATES

   1. In the Beginning

      The regulatory scheme overseeing GMOs began developing thirty years ago when biotechnology ("biotech") was in its early stages. (28) When the technology emerged in the 1980s, the White House Office of Science and Technology Policy ("OSTP") came to a determination that goods containing GMOs were the same as foods produced through traditional crossbreeding methods and could therefore be regulated by existing statutes. (29) Rather than creating a new agency to oversee the developing technology, the OSTP created the Coordinated Framework for the Regulation of Biotechnology from existing agencies. (30)

      The power to make law is vested in Congress by the Constitution. (31) Congress, however, may delegate its legislative power to the executive branch without violating the Separation of Powers doctrine (32) so long as the delegation contains "intelligible standards" to confine agency discretion. (33) Many argue that agencies are better equipped to implement statutes because they employ technical professionals who are familiar with the complex regulatory problems associated with policies regarding their particular area of expertise. (34)

      The three agencies charged with regulating GMOs are the United States Department of Agriculture ("USDA"), the Food and Drug Administration ("FDA"), and the Environmental Protection Agency ("EPA"). (35) Prior to the enactment of the National Standard, GMO labeling was primarily regulated by the FDA. (36) The FDA obtained the bulk of its authority to regulate GMOs from the Federal Food, Drug, and Cosmetic Act ("FDCA"). (37) Additionally, the FDA obtained its GMO labeling authority from the Nutritional Labeling Act of 1990 ("NLEA"). (38)

      Agencies, such as the FDA, are bound by the Administrative Procedure Act ("APA") which sets out agency procedures for making law and policy to ensure actions are fair and deliberate. (39) Although not a legislative body, agencies can pass rules that have a preemptive effect on State law, similar in effect to a Federal legislative law. (40) Agencies may produce these rules through formal rulemaking, similar to adjudication, which results in "a rule with future effect and general application." (41)

      Agencies also engage in an informal rulemaking process in which they give notice of the proposed rule in the Federal Register and provide a period for public comment. (42) The agency then publishes a final rule subject to their discretion. (43) Courts require, however, that the agency publish the data relied upon to justify the proposed rule. (44) This process is commonly called "notice-and-comment" rulemaking. (45)

      Additionally, agencies are authorized to issue policy statements regarding their interpretation of an existing law or how the agency intends to use its discretion. (46) The agency can issue policy statements without performing public rulemaking procedures, so long as the agency does not treat those standards as having the force of law. (47) Policy statements are "designed to inform rather than to control" (48) and there are several benefits to issuing guidance as opposed to engaging in formal rulemaking or notice-and-comment procedures. (49) The FDA chose to issue informal policy statements regarding GMOs and labeling for the flexibility associated with this approach. (50)

      In a 1992 policy statement, the FDA stated that GMO plants were the same as non-GMO varieties and therefore not properly classified as "additives." (51) Instead, the FDA determined that GMOs would be presumed to be "generally recognized as safe" ("GRAS"). (52) In 2001, the FDA issued another policy document advocating a voluntary GMO labeling system providing manufacturers with guidance, however, such disclosures were not required. (53) Judicial review of informal policy statements, such as these, determined that they did not have the force of law and, therefore, did not preempt State legislation. (54)

      Although the FDA has failed to issue GMO regulations, the court has determined their informal policies are subject to judicial review. (55) The court found that the FDA's 1992 policy determination based on the presumption that GMOs are GRAS was not arbitrary or capricious. (56) Additionally, the court took notice of the agency's 2001 guidance for voluntary disclosure of GMOs based on the 1992 policy's presumptions. (57) The court found, however, that the 2001 guidance inferred that the FDA determined GMOs could be labeled "without violating federal law...." (58)

      Biotech companies...