Regulating the regulators: the increased role for the federal judiciary in monitoring the debate over genetically modified crops.

• Author: Denton, Blake

1. INTRODUCTION II. DEVELOPMENT OF GENETICALLY ENGINEERED CROPS IN AMERICA III. REGULATORY AGENCY STRUCTURE A. The United States Department of Agriculture B. The Environmental Protection Agency C. The Food and Drug Administration D. An Incomplete Framework IV. CAUSE FOR CONCERN A. StarLink Corn B. Other Incidents' Of Contamination V. CENTER FOR FOOD SAFETY V. JOHANNS AND THE ROAD TO COME A. APHIS' Disregard of its Statutory Duties B. The Effect of Center for Food Safety VI. MOVING FORWARD I.

INTRODUCTION

Tom Latham comes home to his wife, Jackie, and his four-year old daughter, Riley. It was a miserable day at work, but all of the stress disappears once Tom sees his family and realizes that it is his favorite night of the week, taco night. They sit down to dinner and the family shares their stories of the day over some excellent food. After dinner, Tom relaxes on the couch and turns on the news. In the first story, the anchorman informs the viewers, "Taco Bell brand taco shells are being pulled from the shelves today after it was discovered that genetically modified corn that was only approved for use in animal feed found its way into Kraft's Taco Bell shells. Officials say that the corn's effects on humans are unknown." Tom gets up, walks into the kitchen, and sure enough a box is sitting on the counter with "Taco Bell" printed across it. Tom immediately becomes worried about the safety of his wife and young daughter. He wonders, "How could unapproved food have ended up on the market? Isn't someone supposed to be regulating this stuff?" (1)

As genetic technology continues to advance, there is a growing public debate about the safety risks and potential adverse health effects that could stem from the use of biotechnology to alter crops. (2) There are various conflicting definitions of the term "biotechnology." (3) For the purposes of this Note, the term "biotechnology" will be used interchangeably with the terms "genetic engineering" ("GE") and "genetically modified" ("GM"), both of which refer to the "[p]rocess by which DNA from one or more organisms is inserted into the genetic material of a second organism so that the second organism (host) expresses new traits." (4) While there has been considerable public concern over the effects of altered crops on humans and the environment, the United States government has written off concerns about biotechnology and continues to promote its application to crops. (5) Among potential consequences from using biotechnology to alter crops, opponents fear that these new plant varieties, or "Frankenfoods" as dubbed by some critics, (6) will produce allergens and result in insect immunities to pesticide. (7) Moreover, these critics fear that GM crops cultivated for pharmaceutical purposes, also known as "biopharmed crops," will cross-pollinate with plants intended for food crops and thereby contaminate whole harvests. (8)

Were biopharmed crops to contaminate food crops, it could yield disastrous economic and public health consequences. (9) If lucky, contaminated products would be quickly detected and destroyed. (10) However, if not discovered before distribution, products that are unapproved for human consumption and contain unknown effects on the human body could enter the food supply. (11) The United States would likely face floods of complaints from people claiming adverse health effects from consuming biopharmed crops and crop bans by nations that are concerned about biopharmed crops' effects on humans. (12)

This is not to say that adverse health and environmental effects will necessarily follow from the use of biotechnology. Many altered crops may ultimately have enormous benefits and no social costs. (13) Amongst potential benefits, proponents of GE cite the potential for increased crop yields, reduced necessity for pesticides, more efficient farming practices, and increased shelf life of foods. (14) The federal government has embraced these arguments and endorsed the position that the benefits of GE far outweigh any alleged costs. (15) This sentiment was made explicit by the Reagan administration in 1984 when it adopted the Office of Science and Technology Policy's ("OSTP") Coordinated Framework for the Regulation of Biotechnology. (16) This report glorified the use of GM crops and has remained the dominant opinion in the federal government ever since. (17) In more recent years, the Bush administration and some other proponents have ventured further and suggested that the increased yields produced by GM crops are crucial in the battle to eradicate world hunger. (18)

Despite the considerable public debate over the pros and cons of GE, legal limitations imposed on those engaged in GE have been extremely lax, and often go unenforced by the executive agencies entrusted with regulating these crops. (19) The "patchwork arrangement" of statutes and administrative agencies responsible for regulating GM crops has prevented careful regulation of this growing industry. (20) There are currently three agencies responsible for regulating GM crops: the Environmental Protection Agency ("EPA"), the Food and Drug Administration ("FDA"), and the United States Department of Agriculture ("USDA"). (21) Under this "patchwork arrangement," the EPA regulates the safety of GE crops that constitute pesticides, the FDA has jurisdiction over GE products that it deems to be "food additives," (22) and the USDA has control over the determination of whether and when GM crops may be considered "plant pests." (23) In some situations, jurisdictional responsibility for a particular GM crop might not even be clear. (24)

To date, lawmakers have ignored the arguments put forth by opponents of GE. Congress has left the existing regulatory framework largely unaltered since its creation in the mid-1980s and the President continues to promote the advancement of biotechnology. (25) The federal judiciary has refused to take an active role in this debate, and typically upholds GE policies based on its traditional policy of deference to the procedures and determinations of administrative agencies. (26) However, a recent case brought in the United States District Court for the District of Hawaii premised liability against those responsible for regulating biopharming under an alternative rationale. (27) A lawsuit was brought by opponents of GE based upon one of the core tenets of administration law, namely that a congressional act can limit an agency's discretion even if the statute does not address the agency by name. (28) So, while the USDA, EPA, and FDA are granted great deference in interpreting their responsibilities under the statutes that delegate their authority over GM crops, they are not given this same leeway in interpreting their duties under other congressional acts, such as the Endangered Species Act (29) ("ESA") and National Environmental Policy Act (30) ("NEPA"). In the September 1, 2006 opinion, Center for Food Safety v. Johanns, (31) District Judge J. Michael Seabright of the District of Hawaii concluded that the ESA and NEPA were violated when a subdivision of the USDA issued permits for biopharming crop tests without considering the impacts on Hawaii's environment and endangered species. (32)

While the application of the ESA and NEPA to federal agencies is not groundbreaking on its own, this opinion does constitute the first federal decision to address the issue of biopharming. (33) In this decision, Judge Seabright properly concluded that the simple investigative procedures under these acts had been ignored by the USDA. (34)

This Note will argue that violations, such as those by the USDA in Center for Food Safety, are prevalent in the realm of biotechnology. (35) Thus, more suits are likely to be brought in the coming years by opponents of GM, under precisely the same theory articulated in Center .for Food Safety. (36) This is unfortunate because the agencies responsible for regulating GM crops could avoid liability under these two statutes by complying with clear statutory requirements, which simply involve exploring whether adverse impacts are likely to result from issuing permits for GM crops. (37) However, despite multiple disasters involving GM crops, (38) the USDA, EPA, and FDA have remained lax in their regulation of biotechnology, both under the specific statutes that delegate their power, and under more far reaching statutes like the ESA and NEPA. (39) Although the executive and legislative branches have proven unwilling to correct the inadequacies in the existing biotechnology regulations, (40) the federal judiciary will likely come to play a greater role in forcing the agencies responsible for regulating GM crops to assume accountability. With GE disasters looming, (41) opponents of GM are likely to start utilizing the federal judiciary to make their voices heard.

Part II of this Note will address the development of GM crops in America and the concerns that go along with the growth of biotechnology. It will outline the history of GM products in America and the minimalist regulatory attitudes that have existed since the inception of GE. Part III will examine the existing agency structure entrusted with regulating GM crops. Next, Part IV, through examination of a major GE disaster involving StarLink corn, will illustrate the deleterious effects that are likely to arise under the current regulatory structure. (42) Part V will address the Center for Food Safety v. Johanns opinion and its rationale for holding agencies responsible under the ESA and NEPA. This opinion is likely the first in a string of attacks against the USDA, EPA, and FDA's neglect of statutory duties. Part VI will focus on the roles the public and the federal judiciary will come to play in the regulation of biotechnology.

II.

DEVELOPMENT OF GENETICALLY ENGINEERED CROPS IN AMERICA

Genetically altering crops involves the utilization of recombinant deoxyribonucleic acid ("recombinant DNA") technology to...