Dueling risk assessments: why the WTO and Codex threaten U.S. food standards.

• Author: Ewers, John
• Position: World Trade Organization; Codex Alimentarius Commission

1. INTRODUCTION

   The onset of increased international trade during the 1980s and 1990s has resulted in numerous challenges to United States laws and regulations.(1) The next likely U.S. target of the international trade juggernaut could be the Food Quality Protection Act (FQPA).(2) The Bovine Growth Hormone (BGH) Decision,(3) a recent decision by the World Trade Organization (WTO)(4) concerning the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement),(5) threatens to trump U.S. food standards. This threat arises because the Environmental Protection Agency (EPA), the agency responsible for upholding the FQPA, makes risk assessment decisions that differ from those contemplated by the WTO's interpretation of risk assessment in the SPS Agreement.

   The BGH Decision was the result of a refusal by the European Union (EU)(6) to import meat products treated with growth enhancing hormones.(7) Health risks associated with these hormones concerned the European Union and prompted the ban.(8) The United States challenged and defeated the European ban at a WTO dispute resolution panel hearing.(9) The European Union appealed the decision, but the appellate body affirmed the essence of the panel's ruling. The appellate body agreed with the panel that the European ban violated the SPS Agreement and requested that the European Union comply with the SPS Agreement.(10)

   The SPS Agreement is an international trade compact that regulates laws or regulations that protect human or animal life from risks associated with food additives, toxins, or disease-causing organisms in food.(11) According to the appellate body, the European Union had violated the SPS Agreement because it had not based its ban on an appropriate risk assessment(12) of the hormones.(13) The SPS Agreement requires all member nations to base their sanitary and phytosanitary (SPS) measures on international standards or, if their SPS measures are more stringent than international standards, offer a scientific justification for their measures backed by risk assessments based on international standards.(14) The European SPS measures were neither based on international standards nor supported by a sufficient risk assessment, and they were declared inconsistent with the SPS Agreement because they did not focus on the specific risk at issue in the litigation--the genotoxic potential of the residue of those hormones found in meat derived from cattle to which the hormones had been administered for growth promotion purposes.(15) Hence, risk assessments must focus exclusively on the particular risk of a hazardous environmental agent when used in a specific manner.

   The WTO affirmed its highly particularized approach to evaluating risk assessments and scientific evidence in the Japan Fruit (JF) Decision.(16) Concerned that an alien pest--the coddling moth--might sneak through customs, Japan required testing (d all varieties of the same type of fruit to ensure that coddling moth larvae were dead.(17) The United States challenged and defeated the Japanese SPS measure in a subsequent WTO dispute resolution panel hearing.(18) The appellate body affirmed the panel's approach of requiring Japan to show that testing of all varieties of the same type of fruit was necessary.(19)

   The FQPA regulates the potency and use of pesticides by establishing a single health-based standard determined by a cumulative and an aggregate exposure assessment for pesticides(20) and heightened protection for infants and children from risks associated with pesticides.(21) Although the JF Decision seems unlikely to affect the FQPA because scientific evidence demonstrates the need for the added pesticide measures,(22) the BGH Decision will have an adverse effect on implementation of the FQPA. While the BGH Decision required a particularized assessment of a hazardous agent used in a specific manner to satisfy the SPS Agreement, the FQPA evaluates pesticides through assessment of exposure from multiple sources to particularly susceptible individual.(23) The types of information that will satisfy the SPS Agreement and the FQPA inquiry are different and therefore could create a controversy.

   To throw a little more fuel on the fire, the Codex Alimentarius Commission (Codex), the international agency that sets international standards for food safety,(24) also has responsibility for setting procedures for risk assessments under the SPS Agreement.(25) The risk assessment procedures used by EPA to deduce the risk an environmentally hazardous agent presents to the public are different from those used by Codex. For example, whereas EPA approaches risk assessment through a consumer health-oriented analysis,(26) Codex approaches risk assessment with the potentially conflicting goals of protecting consumer health and promoting the global food trade.(27) Thus, Codex sets the procedural standard for risk assessments under the SPS Agreement, and the WTO sets the substantive standards for the type of information that may be considered in an SPS analysis.

   Understandably, the potential effect of this decision on U.S. laws and regulations is tremendous.(28) This Comment examines the potential collision between the WTO's interpretation of risk assessment and Codex's risk assessment procedures on one side, and EPA's risk assessment procedures and the type of evidence used under the FQPA to justify regulation of pesticides on the other. Part II describes the principles of risk assessment and why the risk assessments of two different groups or agencies might vary even though both groups used pure scientific analysis. Part III examines the SPS Agreement and Codex's methods for setting the procedural requirements in the SPS Agreement. Part IV explains why the EPA and Codex procedural approaches to risk assessment could vary. Part V briefly summarizes the BGH and JF Decisions and explains why the EPA and WTO substantive risk assessments of a pesticide could vary. Finally, Part VI offers suggestions to avoid these conflicts.

2. RISK ASSESSMENT AND RISK MANAGEMENT

   1. Risk Assessment

      Risk assessment is an evaluation of the likelihood and severity of harm to the environment or human health from exposure to a hazardous agent.(29) Risk assessment is essentially a four-step process.(30) The four steps of a risk assessment are 1) hazard identification, 2) dose-response assessment, 3) exposure assessment, and 4) risk characterization.(31) Hazard identification classifies the suspected hazardous agent, its concentration in the environment, the nature of the agent's toxicity, and the ways humans could be exposed to the agent.(32) Dose-response assessment involves a comparison between human exposure to the agent and the severity of the harm caused by the agent.(33) Exposure assessment specifies the population that could be exposed to the agent and identifies the ways in which the population could become exposed.(34) Finally, risk characterization summarizes the results of the previous three steps and estimates the likelihood of the population's exposure to the hazardous agent.(35) Risk characterization also involves discussion of the uncertainties associated with the risk estimate.(36)

      Virtually all risk assessments are plagued by scientific uncertainty.(37) Uncertainties about a suspected hazardous agent create both intellectual problems, because the risk assessors will not know the "scientific truth," and practical problems, because the risk assessors will find it more difficult to determine the risks to the population.(38) In the face of uncertainties, agencies responsible for setting safety standards must make science policy choices.(39) Science policy choices--also called default options or inference guidelines--are standard agency guidelines for making a particular choice when confronted with several scientifically plausible approaches.(40) That is, default options serve as bridges over data gaps in the scientific evidence.(41) Since virtually all scientific data is incomplete or ambiguous in some fashion, "risk assessments must use general knowledge and policy guidance to bridge data gaps."(42) Hence, risk assessment is primarily the collection and evaluation of data from a multitude of scientific disciplines--epidemiology, toxicology, statistics, and pathology, just to name a few.(43) Afterwards, the agency responsible for the data collection and evaluation then applies science policy choices to data areas plagued by uncertainties.(44)

   2. Risk Management

      Risk management uses the information gathered through risk assessment to create policies to deal with a hazardous environmental or health agent.(45) Whereas risk assessment is limited to scientific inquiries, risk management includes economic, social, and political values.(46) Risk assessors are responsible for determining the risks of hazardous agents through scientific analysis, but risk managers are responsible for considering the results of risk assessments and competing societal goals and values and creating strategies for dealing with the hazardous agents.(47)

   3. Interplay Between Risk Assessment and Risk Management

      Though the two concepts are supposed to be distinct, inevitable interplay exists between risk assessment and risk management.(48) Risk assessment includes science as well as policy decisions.(49) For example, decision makers and risk managers choose what type of default options--such as degree of conservatism and acceptability of risk--risk assessors should use when faced with equally plausible scenarios or data gaps.(50) Risk managers give risk assessors the lenses through which they are supposed to view scientific uncertainty. Therefore, the risk priorities created by risk managers shape the decisions made by risk assessors.(51) The final product of a risk assessment is not necessarily based completely on scientific analysis; rather, the final product is based on the risk priorities created by the risk managers in charge of dealing with the hazardous...