Nothing but unconditional love for conditional registrations: the conditional registration loophole in the Federal Insecticide, Fungicide, and Rodenticide Act.

• Author: Lau, Joanna

1. INTRODUCTION II. FIFRA HISTORY A. Insecticide Act of 1910 B. Federal Insecticide, Fungicide, and Rodenticide Act of 1947 C. Federal Environmental Pesticide Control Act of 1972 D. Federal Pesticide Act of 1978 III PESTICIDE REGISTRATION PROCESS A. General Registration B. Conditional Registration Exceptions IV. FLAWS IN THE CONDITIONAL REGISTRATION PROCESS A. Problems with Conditional Registrations "In Theory" B. Problems with the "New Active Ingredients" Provision 1. Insufficient Data Requirement 2. Risk Assessment for New Chemicals Requirement 3. Public Interest Requirement C. Problems with Conditional Registrations "In Effect" D. Problems with the National Environmental Policy Act of 1969 V. LEGAL EFFECTS OF EPA'S IMPLEMENTATION PRACTICES A. Applicants and Users B. Relief for Adversely Affected Parties Through Litigation VI. SUGGESTIONS AND PREDICTIONS A. Better Data Tracking and Data Deadline Enforcement B. Abandon Conditional Registrations Altogether VII. CURRENT CASE LAW DEVELOPMENT A. NRDC v. EPA: Conditional Registration of Nanosilver B. CFS Petition and Complaint to EPA: Conditional Registration of Clothianidin VIII. CONCLUSION I. INTRODUCTION

   During the past century, federal law has had a wide and varied relationship with pesticides. As with any evolving area of law, changes in statutes along with developments in case law signal corresponding shifts in societal attitudes. Far removed from its humble beginning as a statute only concerned with pesticide efficacy, (1) federal pesticide law has grown in the last 104 years to include environmental and human safety provisions, supported by the latest reliable scientific data available. (2) The modern Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (3) focuses on safety by requiring pesticide producers to register all pesticides with the U.S. Environmental Protection Agency (EPA) before entering the market, and to prove their pesticides pose no unreasonable adverse effects to human health or the environment. (4)

   On its face, FIFRA (5) pesticide registration provisions such as extensive data requirements and the possibility of civil and criminal penalties seem to accurately reflect society's concern for safety. (6) However, delving deeper reveals a significant loophole to the safety requirements Congress contemplated. Specifically, FIFRA's conditional registration provision allows pesticide manufacturers to circumvent a requirement of proving their pesticide is safe by providing a quasi-registration status in the absence of critical data. (7) Moreover, EPA's lax enforcement measures illustrate that EPA has abused the conditional registration exception and has relied on the exception as its main way of allowing pesticides to market. (8)

   This Comment argues that the conditional registration provision of FIFRA violates--in theory and in effect--the purpose of FIFRA's pesticide registration requirement, which is to prevent pesticides that pose "unreasonable adverse effects" to human health and the environment from entering the market. (9) Part II describes the evolution of federal pesticide law from the first federal pesticide law in 1910 to the present. Part III outlines the registration process for pesticides and compares full registration requirements with conditional registration requirements. Part IV explores the flaws in the conditional registration process, both in terms of theoretical invalidity and EPA's implementation. Part V discusses the legal effects that result from EPA's granting of conditional registration status, as well as litigation options for adversely affected parties to attain relief. Part VI offers suggestions for EPA to improve the conditional registration program. Part VII describes current case law relating to conditional registrations. This Comment concludes the conditional registration provision is a loophole to FIFRA that poses detrimental implications not intended by Congress, and that even in the absence of Congressional action, litigation is a viable means for ensuring EPA complies with the more stringent requirements for full registration under FIFRA.

2. FIFRA HISTORY

   Throughout its century-long history, pesticide regulation steadily became more comprehensive, culminating in Congress's addition of human health and environmental safety standards in the Federal Environmental Pesticide Control Act of 1972 (FEPCA). (10) FEPCA required EPA to consider whether a pesticide would cause "unreasonable adverse effects on the environment" during the registration process. (11) Just a few years later, however, Congress enacted the Federal Pesticide Act of 1978, (12) which gave the EPA power to grant conditional registrations. The addition of conditional registrations to the pesticide registration process remains controversial and is at the heart of this Comment.

   1. Insecticide Act of 1910

      National pesticide legislation has only been in place for a little more than one hundred years, and the scope of pesticide law has changed drastically and increased steadily during that time. In 1910, Congress enacted the first pesticide-related law, the Insecticide Act of 1910 (Insecticide Act). (13) The Insecticide Act addressed pesticide labeling and prohibited the sale of fraudulently labeled pesticides. (14) Importantly, the Insecticide Act granted pesticide program oversight powers to the U.S. Department of Agriculture (USDA), by mandating that the USDA "collect[] and examin[e]" pesticides and related products sold or manufactured in the United States. (15) The Insecticide Act neither required pesticide registration nor established specific standards for pesticide efficacy or environmental or human safety. (16)

   2. Federal Insecticide, Fungicide, and Rodenticide Act of 1947

      In 1947, Congress adopted the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA I), (17) which broadened the scope of national pesticide law by including more types of pesticides than the Insecticide

      Act, (18) requiring product registration by USD A prior to interstate or international shipment, and mandating warning labels and instructions. (19)

      Moreover, FIFRA I required every "economic poison" distributed or sold in the United States to be registered with the Secretary of Agriculture, (20) and authorized the Secretary, after an opportunity for a hearing, to "determine economic poisons, and quantities of substances contained in economic poisons, which are highly toxic to man." (21) FIFRA I also prescribed criminal penalties for violations of this registration requirement. (22) Like its predecessor the Insecticide Act, however, strikingly absent from FIFRA I registration was any safety requirement. (23)

   3. Federal Environmental Pesticide Control Act of 1972

      After remaining largely unchanged for close to thirty years, (24) Congress drastically amended FIFRA by passing the Federal Environmental Pesticide Control Act of 1972 (FEPCA), (25) "essentially rewriting]" it to include human health and environmental safety standards. (26) The impetus for Congress's overhaul stemmed from increasing public awareness of the dangers of pesticide use in terms of environmental hazards and human safety, coupled with the inadequacy of FIFRA I to address those dangers. (27)

      In his presidential signing statement, President Nixon stated that FEPCA:

      [Represents the most significant legislation in this field since [FIFRA I] was passed in 1947.... [T]he Federal Government, for the first time, will be able to exercise adequate control over the use of pesticides. We will now be able to ensure that we can continue to reap the benefits which these substances can contribute to the well-being of America ... without risking unwanted hazards to our environment and our health. (28) Indeed, Congress's amendment shifted the focus and purpose of FIFRA from efficacy and consumer deception to consumer and public safety and environmental consequences of pesticide use, in light of up-to-date science. (29) The most significant changes introduced by FEPCA were 1) an environmental health component in the registration process requiring EPA to consider whether a pesticide would cause "unreasonable adverse effects on the environment" (30) and 2) an expansion of EPA's jurisdiction and enforcement powers. (31)

   4. Federal Pesticide Act of 1978

      Congress again made major changes to U.S. pesticide law when it enacted the Federal Pesticide Act of 1978 (FPA). (32) Most significantly, the FPA gave the EPA Administrator the power to grant conditional registrations for new pesticides as well as to amend a currently registered pesticide. (33) By allowing pesticide producers to forego full pesticide registration, Congress hoped to streamline pesticide registration without jeopardizing environmental or human health safety. (34) Congress felt that because of the safeguards in place, the allowance of conditional registrations would only enable EPA to "make available more pesticides that are deemed to be basically safe." (35) The current conditional registration provisions remain largely the same as those passed in 1978. (36)

3. PESTICIDE REGISTRATION PROCESS

   FIFRA requires applicants to submit extensive scientific data regarding safety when applying to register a pesticide. The EPA Administrator is charged with granting registration to those pesticides that will not "cause unreasonable adverse effects on the environment." While the FIFRA registration scheme focuses mostly on the full registration process, EPA has in practice registered most pesticides under conditional registration. This practice has resulted in most pesticides reaching the market and the environment while their safety is yet unknown.

   1. General Registration

      The current language of FIFRA requires anyone who sells or distributes a pesticide to register the pesticide with EPA. (37) FIFRA outlines a detailed procedure for new pesticide registration, (38) including the important and cumbersome requirement of submitting data pursuant to 7 U.S.C...