Equivalence: not quite close enough for the international harmonization of environmental standards.

I. INTRODUCTION

As noted by economist Herman Daly, the world used to be "relatively empty of human beings and their belongings ... and relatively full of other species and their habitats."(1) But many people, particularly urban residents, might say that quite the opposite is now true.(2) At a minimum, the impacts of current human activity are significant enough that the environment must be actively managed to a degree unimaginable just a century ago.(3) Over the last forty years, many nations have responded by developing complex environmental protection regimes in national law.(4)

Nevertheless, a competing effort that often overshadows environmental protection is the generation of a higher standard of living through economic growth.(5) According to traditional economic theory, the key to growth is expanded international trade.(6) Until the latter half of this century trade was neither very expansive nor very international. During the decades preceding the Second World War, national policies of protectionism and high tariff structures constrained global trade and, in the minds of many, contributed to the political tensions that gave rise to that devastating war.(7) These obstacles to trade are now mostly gone, vanquished by trade liberalization tools such as the General Agreement on Tariffs and Trade (GATT),(8) the European Union (EU),(9) and the North American Free Trade Agreement (NAFTA).(10) Since 1960 annual world trade has increased from $60 billion to $6.5 trillion in constant dollars, and world economic production has quadrupled.(11)

Having won the major battles against tariff barriers, business leaders and trade officials are now focusing their trade liberalization efforts on nontariff barriers (NTBs)--environmental, health, and safety standards and technical regulations that act as artificial barriers to trade.(12) The problem, they argue, is not that these standards and regulations exist; after all, each nation has the sovereign right to regulate commerce with its citizens, protect their health, and safeguard their environment.(13) Rather, the problem lies in the differences in coverage and stringency between the standards of different nations.(14) When one country's standard is higher than that of another, it acts as an NTB by making the importation of products from the other country impossible or, at best, possible only after costly modifications.(15) Standards disparities obstruct imports and exports, create inefficiencies, and increase costs for international business, which in turn impedes international trade and slows the global train of prosperity.(16) Worse yet, countries can purposely employ environmental standards as NTBs for protectionist reasons.(17) For trade liberalizers, the solution to the costs and barriers resulting from standards disparities is to eliminate the disparities by making the standards the same or as similar as possible.(18) This process is called harmonization.(19)

There are two possible methods or models of harmonization: full harmonization and equivalence.(20) These two methods are not interchangeable because they produce significantly different results, particularly in the case of substantive standards for the protection of health, safety, or the environment. Under full harmonization, two or more parties adjust their differing standards until they are the same. If this harmonization is in an upward direction, it strengthens the level of protection. Under equivalence, in contrast, the parties do not adjust their standards--they only agree to treat their differing standards as if they were the same. This produces the opposite result, because it allows the weaker standard to serve as a bypass route around the stronger one, thereby invalidating the stronger and reducing the level of protection.(21)

This Comment asserts that equivalence may be acceptable for the harmonization of regulatory procedures in some instances; however, it is unsuitable for the harmonization of substantive standards between nations, and of health, safety, and environmental standards in particular. Nevertheless, the trade officials of the European Union and the United States appear to be focusing on only one method--equivalence--in their joint pursuit of deregulation and trade liberalization.(22) The central reason for this focus appears to be the mandates of the Agreement on Technical Barriers to Trade (TBT Agreement)(23) and the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement)(24) of the World Trade Organization (WTO),(25) which both encourage and require member nations to employ equivalence in harmonizing standards.(26) Additional factors include the desires of organized business, the increasing strain on regulatory resources posed by growing international trade, and the inherent difficulty of pursuing full harmonization.(27)

Part II of this Comment investigates the theory and dynamics of harmonization and distinguishes the two models or methods of harmonization. Part III discusses the factors that propel the United States toward the harmonization of regulatory standards and procedures, including the United States's responsibilities under the TBT and SPS Agreements of the WTO. Part IV describes the harmonization activities of the United States to date, focusing on its choice and use of equivalence, and points out a number of likely future targets for harmonization by the United States. The Comment concludes by arguing for the use of full and upward harmonization rather than equivalence, especially as applied to environmental standards.

II. HARMONIZATION THEORY

A. Background and Definitions

Harmonization is the process of bringing two or more standards, technical regulations, or conformity assessment procedures (CAPs)(28) into accord with each other. In general usage, the term "standard" refers to a "definite rule, principle, or measure established by authority."(29) Accordingly, standards may be mandatory, as when set by governmental authorities, or they may be voluntary, as when offered by nongovernmental authorities such as industry groups or scientific experts that grant certifications to products or practices.(30) The term "technical regulation" refers to a governmentally imposed rule that sets a standard or specifies a procedure such as a CAP.(31) Harmonization of standards, technical regulations, and CAPs can take place within the following two contexts: 1) bilaterally or multilaterally between different nations, and 2) between nations and international standard-setting organizations.(32)

Historically, the primary purposes of harmonization have been economic integration and the reduction of trade barriers and regulatory burdens.(33) In theory, harmonization of standards and procedures increases market accessibility, reduces costs, brings productivity improvements through specialization on the basis of comparative advantage, and boosts overall growth.(34) Harmonization can also lead to improved environmental protection if the harmonization is upward--that is, if nations with less protective standards raise them to the levels of the more protective nations' standards.(35) For example, the previously lax southern European countries rapidly developed the environmental protection regimes that were required for their integration into the European Union.(36)

In fact, the most successful practitioners of harmonization are the member states of the European Union, a regional trade organization that has its trade facilitation roots in the European Coal and Steel Community and the European Economic Community.(37) Perhaps taking cues from the successful history of European patent law harmonization,(38) the EU has applied harmonization in various regulatory areas, including environmental regulation, as its central legislative tool in creating a common internal market.(39) Harmonization has also assured international importance by its inclusion in the TBT and SPS Agreements.(40)

B. The Full Harmonization Model

There are two slightly, but crucially different, models of harmonization: the full harmonization model and the equivalence model. The first, commonly mislabeled simply as "harmonization," is more accurately described as "full harmonization" or "equalization." Under full harmonization, two or more countries agree to adopt the same (equal or identical) standard.(41) Countries may equalize their standards in one of the following three ways: 1) upward harmonization, in which the country with the lower standard strengthens it to match the higher one; 2) downward harmonization, in which the country with the higher standard weakens it to match the lower one; or 3) what may be called compromise harmonization, in which the two countries negotiate a new standard at an intermediate level.

Each of the three types of full harmonization has drawbacks that make the task difficult. Countries arrive at levels of environmental protection through formal or informal cost-benefit analyses. Upward harmonization, then, requires the country that previously had the lower standard to bear higher economic costs than it had deemed optimal.(42) Conversely, downward harmonization deprives the country that previously had the higher standard of some environmental protection that it had decided was necessary. Compromise harmonization, of course, involves both of the above. Advocates of environmental protection generally consider the first of the three methods--upward harmonization--to be the ideal method and consider its economic costs to be acceptable.(43) In contrast, downward harmonization best serves the interests of trade because lower standards generally translate into lower costs for business. The resulting conflict is a focal point in the trade/environment debate.(44)

In the 1970s and early 1980s, the European Union applied full harmonization in many fields to achieve its internal harmonization of standards, but encountered exactly the drawbacks noted above.(45) By the 1980s, the European Union had acknowledged the challenges of full harmonization by switching to the second and much easier model of harmonization for most policy areas.(46)

C. The Equivalence Model

The second model of harmonization is the equivalence model, also called convergence, approximation, or less-than-full harmonization.(47) Under the equivalence model, one country agrees to accept another country's disparate standard as being equivalent to its own, without actually equalizing the standards.(48) When two or more countries pledge to accept each other's standards as equivalent, a mutual recognition agreement (MRA) is formed.(49) As Richard Merrill points out, equivalent does not mean "the same"--it only means functionally equivalent,(50) or functionally substitutable. In forming an MRA, each country in essence says that the other's standards and regulatory system are close enough to its own that it can entrust the protection of its citizens in that matter to the other country.

Rather significantly, trade officials, not environmental protection officials, appear to have invented the concept of equivalence to serve as a harmonization tool--most likely as a result of Europe's difficulties in achieving full harmonization of standards.(51) The first mention of equivalence in U.S. law is found in an obscure provision of the Trade Agreements Act of 1979 (1979 TAA).(52) The provision established the process by which a U.S. agency, such as the Food and Drug Administration (FDA), may determine a foreign nation's sanitary or phytosanitary standard to be equivalent to that of the United States.(53) The 1979 TAA :states that its purpose is to "foster the growth and maintenance of an open world trading system" and does not mention the protection of health, safety, or the environment.(54) The United States Congress passed the 1979 TAA just months after the adoption into the GATT of the 1979 Agreement on Technical Barriers to Trade (Standards Code).(55) The Standards Code encouraged parties to harmonize their standards with international standards to ensure that national laws would not be used as artificial barriers to trade.(56)

D. The Ramifications of Equivalence

The most important aspect of equivalence is that it is not the same as full harmonization; equivalent standards are not actually the same--they are only functionally similar.(57) This distinction becomes very important in light of the nature of standards, which is such that they either are met or are not met. A standard serves as a positive line that divides everything above it from everything below it.(58) For example, a person who is either eighteen years of age or older may vote in the United States, but a person who is not yet eighteen may not vote. The age of seventeen years and 364 days is close, and it may be functionally equivalent in most other situations, but it does not suffice to meet the standard. It follows that equivalence is intrinsically insufficient as a model for harmonization of mandatory legal standards because it is founded on the concept of satisfying one standard by satisfying another one, which is to say, by not satisfying the first standard at all.

In the context of mandatory standards imposed by legislatures or regulatory agencies, as in the case of U.S. standards and regulations, equivalence permits a technical evasion of those standards.(59) National standards must apply equally to imported products and domestically produced products if the standards are to have more than sporadic and haphazard effectiveness. However, if a foreign standard is treated as equivalent to its domestic counterpart, then a "back door" is created through which a product can gain approval without meeting the domestic standard.(60) Such an arrangement allows products to easily circumvent the domestic standard, effectively invalidating that standard.

With regard to health, safety, and environmental standards particularly, the equivalence model produces an especially dangerous and unacceptable result: it creates a path around the standards that nations employ to protect the lives and health of their citizens. Governments formulate and implement such standards expressly to protect their citizens from harms, whether the harms stem from domestic or foreign actors and products. In simplified form, the democratic governments' development of regulatory measures for health and environmental protection involves two phases: risk assessment and risk management.(61) Risk assessment involves the calculation and estimation of risk through scientific inquiry.(62) Risk management entails juxtaposing the scientific results of risk assessment with the social, cultural, economic, and political goals and values of the society.(63) Regulators ascertain these goals and values in part by considering the opinions and desires of the citizenry tendered through public participation in the regulatory process, such as those required by U.S. administrative procedure.(64) Because these values and goals can differ greatly from society to society, standards may differ even when there is an international consensus on the scientific factors.(65)

It would seem axiomatic that citizens in a democratic nation have the right to incorporate their opinions and desires into the process of determining the level of health, safety, and environmental protection afforded to them by their laws. However, by way of the back door effect, equivalence effectively replaces a nation's customized standards with foreign standards that the citizens had no hand in formulating and which they cannot dispute, modify, or abolish. In so doing, equivalence overrides the results of the risk management phase and removes the citizens' social and cultural values from the policy-making process. As a result, equivalence abridges the sovereignty of those citizens.

In theory, equivalence appears to pose less of a threat to sovereignty and regulatory integrity when applied to conformity assessment procedures. In contrast to substantive standards, which result from a two-stage risk assessment-risk management process that includes socially determined subjective components, CAPs derive from more purely objective considerations. The determination of appropriate sampling, testing, and inspection processes for products depends on scientific, technological, and practical considerations that do not necessarily require the incorporation of social and cultural values. If two different testing methods can produce equivalent assurances of conformity with a given standard, then both should suffice to produce the outcome that the public requires. In this case, the back door effect technically exists--products can evade U.S. procedures--but this process still achieves the public's goals and values. Thus, in the procedural context, equivalence technically produces the back door effect, but the public's substantive standards and desired levels of protection remain intact. Of course, the suitability of equivalence for the harmonization of procedures can quickly disappear if the integrity and effectiveness of the foreign conformity assessment bodies that implement the accepted procedures are questionable. On the whole, however, equivalence should suffice for the harmonization of CAPs.

In sum, although equivalence theoretically is appropriate for the harmonization of procedures such as CAPs, it is not suitable for the harmonization of substantive standards, particularly those instituted for the protection of health, safety, or the environment. The European Union, apparently in recognition of this, has refused to apply less-than-full harmonization within its territory to standards affecting food, medicines, and potentially hazardous products.(66) And in the case of environmental standards, the European Union Parliament has affirmed that full and upward harmonization is necessary.(67)

III. U.S. MOTIVATIONS FOR HARMONIZATION

In spite of this clear conclusion, the professional harmonizers of the European Union have worked closely with U.S. trade officials since the late 1980s to develop equivalence as the main method of harmonization between the two.(68) In addition to the European Union's advice and encouragement, three main factors continue to pressure the United States to form equivalence agreements with other countries and the European Union.

A. The Desires of Organized Business

The first factor is the push by international business for the further reduction of nontariff barriers to trade. Considering the popular skepticism toward free trade agreements that manifested itself politically on both the right and the left during the 1992 U.S. elections,(69) and in the 1999 Seattle, Washington WTO protests,(70) it is not surprising that business leaders have come to see behind-the-scenes changes in regulatory policy as being a faster and quieter road to expanded trade.

One of their most powerful tools is the Transatlantic Business Dialogue (TABD), a business group of over two hundred U.S. and EU corporations that lobbies to "boost transatlantic trade and investment opportunities through the removal of costly inefficiencies caused by excessive regulation, duplication and differences in the EU and U.S. regulatory systems and procedures."(71) The thirty-odd working groups of TABD develop joint EU-U.S. trade policy recommendations on issues of concern to international business and forward them to the United States Secretary of Commerce and the European Union Commissioner for Trade and Industry.(72) Initiated in 1994 by the late Secretary of Commerce Ron Brown,(73) TABD has employed its special relationship(74) with trade officials on both sides of the Atlantic to successfully pressure the United States and the European Union to implement over fifty percent of its recommendations over the last three years.(75) Moreover, input from TABD comprised a significant portion of the public opinion that FDA considered in developing its sectors of the U.S.-EC MRA.(76)

B. The Increasing Demands on Regulatory Resources

The second factor behind the United States's foray into harmonization is the pressure felt by U.S. regulatory agencies as a result of the huge increases in international trade.(77) In recent years, U.S. agencies that have statutory responsibilities for inspecting and regulating certain types of products imported into the United States have been facing massive workload increases with diminishing resources.(78) In the case of FDA, the value of EU pharmaceuticals and medical devices imported into the United States nearly doubled in just three years between 1994 and 1997, resulting in only one FDA inspection for every $60 million of imports.(79) This inspection gap is expected to widen to one inspection for every $100 million of imports in the year 2000.(80) FDA officials expect that equivalence agreements will allow regulatory agencies to "conserve considerable resources"(81) and generate cost savings for industry.(82)

C. Legal Obligations Under the WTO

The third factor pushing the United States towards harmonization is its responsibilities as a member state of the WTO. At the 1993 culmination of the Uruguay Round of international trade negotiations, the 1940s-vintage global free trade system known as GATT was reworked into the new framework of the WTO Agreements.(83) The WTO Agreements combined the original GATT of 1947 with a number of new collateral agreements, including the SPS and TBT Agreements.(84)

The SPS Agreement covers measures enacted to protect the life and health of humans, animals, or plants from risks arising from pests, diseases, toxins, additives, and the like.(85) The TBT Agreement covers technical regulations and product standards other than those covered by the SPS Agreement, in addition to conformity assessment procedures.(86) Both agreements include significant obligations that lead to the harmonization of standards--in fact, they point toward harmonization on a global scale--but they do so in somewhat different, ways.(87)

Because U.S. trade officials were key players in the Uruguay Round negotiations that produced the WTO Agreements, they could not have been surprised by these responsibilities. Even before the agreements took effect in early 1995, U.S. agencies had already participated in bilateral mutual recognition talks with the European Union and had developed the MRA process to such a degree that the Administrative Procedure Act(88) required them to solicit public comments on the matter.(89)

1. Harmonization Under the TBT Agreement

In its coverage of standards, called "technical regulations,"(90) and conformity assessment procedures, the TBT Agreement discusses both harmonization with other member states and harmonization with international standards.(91)

Article 2.7 encourages but does not require member states to harmonize their standards with those of other member states through the use of equivalence.(92) Article 6.3 encourages the same for CAPs.(93) The suggestion of equivalence for the harmonization of CAPs is acceptable, but, because of the back door effect, the suggestion of equivalence for the harmonization of substantive standards is inappropriate.(94) However, because these provisions are hortatory, they do not force member states to open the back door of equivalence.

In contrast, Article 2.4 requires that member states use "relevant international standards(95) ... as a basis" for their standards if such international standards exist or are imminent.(96) Article 5.4 repeats this requirement for CAPs.(97) These two provisions contemplate unilateral harmonization with international standards, in contrast to the bilateral and multilateral harmonization with other member states that Articles 2.7 and 6.3 encourage. Member states may avoid this mandate to harmonize only when the international standards "would be an ineffective or inappropriate means for the fulfilment [sic] of the legitimate objectives pursued."(98) Thus, the TBT Agreement makes harmonization with international standards mandatory, but does not specify which method of harmonization member states must use. By requiring that member states use international standards "as a basis" instead of requiring that they match them exactly, Article 2.4 appears to allow for the use of either full harmonization or equivalence.(99)

In the case of full harmonization, the nonnegotiable nature of international standards requires member states to unilaterally make all of the adjustments necessary to match the international standard. Upward adjustments presumably lead to increased environmental protection and so are beneficial, but downward adjustments, which produce the opposite result, are equally likely to be required. Either way, the member state loses its ability to determine its own appropriate level of protection because the unaccountable international body's standards overrides the member state's standards.(100) Such a result does not comport with democratic principles.

Interestingly, equivalence presents a somewhat better alternative regarding harmonization with international standards for two reasons. First, equivalence mitigates the deprivation of autonomy that accompanies forced adoption of international standards. Theoretically, member states do not have to adjust their standards to the same degree that they would under full harmonization. This benefit accrues both to member states required to harmonize upward and to those required to harmonize downward. Thus, equivalence not only gives member states with more stringent standards a way to mitigate standards-lowering pressure from the WTO, but also could cushion the blow of mandatory upward harmonization for states with less stringent standards.

Second, in the context of unilateral harmonization with international standards, equivalence does not cause the back door effect. Assuming the absence of mutual recognition agreements with other states, there is no back door. The member state may have adopted the international standard; however, because international standards organizations do not assess conformity, all products must still apply to a member state's conformity assessment body for approval under its standard.

Therefore, the dynamics of harmonization may make equivalence a more attractive option than full harmonization for the purposes of complying with Articles 2.4 and 5.4 of the TBT Agreement. The flexible, "as a basis" language, the promotion of equivalence in Articles 2.7 and 6.3, and the greater ease of attaining equivalence also suggest that member states are more likely to choose equivalence. Nevertheless, the broad power of dispute resolution panels to interpret the provisions of the TBT Agreement means that there is no guarantee that equivalence will suffice. If a WTO dispute resolution panel were to interpret the "as a basis" language as requiring a closer fit, then Article 2.4 could equate to a requirement of full harmonization.

2. Harmonization Under the SPS Agreement

Like the TBT Agreement, the SPS Agreement covers both standards and procedures, but it unifies them under a single definition of "sanitary or phytosanitary measure"(101) and applies only one set of requirements to them.(102) By specifying that, "[t]o harmonize ... [SPS] measures on as wide a basis as possible, Members shall base their ... [SPS] measures on international standards," Article 3(1) requires member states to use equivalence in the unilateral context.(103) This is only avoidable if the member state shows that it has a scientific justification for maintaining a standard that is more strict than the international standard.(104) The major difference in the SPS Agreement pertains to bilateral and multilateral harmonization of standards and is found in Article 4, which requires a member state to accept the SPS measures of another member state as equivalent to its own as long as the other member state objectively demonstrates that its measures achieve the importing member's level of protection.(105)

The most forward provision of the agreements is Article 4(2), which requires member states to, "upon request, enter into consultations ... [for the mutual] recognition of the equivalence of specified ... [SPS] measures."(106) Under this language, a party could be forced to harmonize standards that it is not ready to adjust, or might be required to harmonize its standards downward to the detriment of its citizens' health. Because the SPS Agreement lacks a definition of equivalence, it is somewhat unclear how this provision would be enforced. The term harmonization is defined as the "establishment, recognition, and application of common [SPS] measures by different Members,"(107) but Article 4(2) uses the term equivalence, not harmonization; therefore it does not clarify the issue. The only certain conclusion is that the vague aspects of these agreements are likely to gain definition through the dispute resolution system. Consequently, the United States's WTO obligations appear to push it toward the use of the more flexible, albeit flawed, equivalence model.

IV. U.S. HARMONIZATION EFFORTS

As the United States began exploring the trade facilitation possibilities of harmonization in the late 1980s,(108) the European Union was formulating and implementing new goals for both the accelerated harmonization of product standards within the European Union and the extension of harmonization of product testing and certification on a global level.(109) By 1991 the United States and the European Union had joined together to coordinate laying the groundwork for harmonization agreements between the two largest economies of the world.(110) On June 20, 1997, their cooperative efforts bore fruit when United States Trade Representative Charlene Barshefsky and Sir Leon Brittan, the European Union's trade commissioner for Asia and North America, signed the Agreement on Mutual Recognition Between the United States of America and the European Community (U.S.-EC MRA),(111) which is an equivalence agreement covering product testing and certification in six product sectors.(112)

A. Equivalence Applied: The U.S.-EC Mutual Recognition Agreement

The U.S.-EC MRA consists of an umbrella agreement and sectoral annexes covering the following six product sectors: telecommunications equipment, electromagnetic compatibility, electrical safety, recreational craft, pharmaceutical good manufacturing practices, and medical devices.(113) In the MRA the United States and the European Union created a system for recognizing each other's conformity assessment procedures as equivalent.(114)

In essence, the United States and the European Union agreed to accept each other's regulatory systems as equivalent with regard to inspection processes of manufacturing plants and products. The result is a system of conformity assessment by proxy.(115) Instead of inspecting European manufacturers or products themselves, U.S. regulators will accept the inspection reports generated by European regulatory authorities or their approved private conformity assessment bodies as being sufficient to demonstrate conformity with U.S. standards, and European regulators will act similarly regarding U.S. manufacturers and products.(116) The agreement appears to recognize only the equivalence of systems and practices, not the equivalence of standards. As such, it does not harmonize the standards of the parties. In response to inquiries from consumer groups, U.S. Trade Representative officials have confirmed this point, stating that all U.S. standards and regulations will remain unchanged as a result of any MRA.(117)

The primary issue of concern is whether the U.S.-EC MRA, as an equivalence agreement for CAPs, is subject to the same flaw--the back door effect--that makes equivalence generally unsuitable for the harmonization of standards.(118) If the agreement involves only the mutual recognition of the equivalence of CAPs, and not of standards, then it is likely to avoid causing the back door effect and may constitute an acceptable use of equivalence.(119) Article 4(3) of the umbrella agreement states that the MRA "shall not be construed to entail mutual acceptance of standards or technical regulations of the Parties and, unless otherwise specified in a Sectoral Annex, shall not entail the mutual recognition of the equivalence of standards or technical regulations."(120)

Article 4(3) thus appears to preclude the back door effect--except that it includes the qualifying phrase "unless otherwise specified in a Sectoral Annex."(121) Although none of the sectorals currently contemplate the equivalence of standards, the parties can easily amend them at any time through the Joint Committee (JC).(122) Also, the U.S.-EC MRA does not guarantee that future sectorals will not attempt to apply equivalence to standards and thereby threaten the effectiveness of national standards. If the U.S.-EC MRA is not amended to close this loophole, then the U.S.-EC MRA must be monitored carefully to ensure that this loop-hole is not utilized. In conclusion, although equivalence may be acceptable for the harmonization of procedures, provided that it does not affect substantive standards, the U.S.-EC MRA does not necessarily serve as an example of such an application.

B. Recent Developments in the Harmonization Arena

The United States's experience with harmonization has not been trouble-free. Not only did the United States and the European Union need two years to negotiate the MRA, but difficulties in working out the details of the relationships between U.S. and European regulatory authorities kept it from entering into force for an additional year and a half.(123) January 1999 found progress on implementation still stalled due to continuing difficulties with budgeting, pointed inquiries and scrutiny by Congress, and apparent foot-dragging on the part of regulatory officials.(124) Both trade officials and regulatory officials endured attempts at interference by environmental and consumer groups, which raised objections and requested increased opportunities for public participation at the formative stages rather than after the decision making had been completed and the input could have no substantive effect. And finally, although the similarities in levels of development, regulation, and wealth between the United States and the EU suggest that the U.S.-EC MRA should have been easier to negotiate than it was, the nature of both parties' complex regulatory systems and legal structures appears to have added challenges to the endeavor.

Nonetheless, it is unquestionable that harmonization is here to stay and that trade officials will seek to apply it further.(125) Under the dominant economic paradigm of consumption-based growth, progress through globalization requires the further reduction of nontariff barriers to trade.(126) Accordingly, the U.S.-EC MRA was designed as a modular treaty with an umbrella agreement that allows any number of sectorals to be added to the MRA.(127)

The United States and the European Union have recently discussed a number of areas or sectors as candidates for harmonization, including marine safety equipment, calibration services, road safety equipment, elevators, cosmetics, and enological practices.(128) In addition, the United States and the European Union may soon sign a recently negotiated veterinary biologics agreement that will become a new sectoral annex to the U.S.-EC MRA.(129) Business leaders, through TABD, have also called for the negotiation and addition to the U.S.-EC MRA of a sectoral on good laboratory practices for chemical products.(130) It is unclear whether harmonization in these various sectors would involve merely the harmonization of procedures and the use of foreign regulatory resources as proxies, or whether standards would be harmonized. If the latter is the case, full harmonization rather than equivalence should be used.

C. The Future of Harmonization

To date, the United States government has not publicly explained the difference between full harmonization and equivalence, nor has it described the criteria that its negotiators apply in choosing which model of harmonization to use in a given sector.(131) In all likelihood, however, U.S. trade officials will not base their choice of harmonization models on the theoretical mandates of the procedures-standards and unilateral-multilateral harmonization dichotomies. Rather, their choice is likely to be substantially influenced by practical and political considerations, which propel the United States toward the use of equivalence for the harmonization of both procedures and standards alike.(132)

The first of these considerations is the preference of the business community for the use of equivalence as the fastest and easiest method of reducing regulatory burdens.(133) Pursuant to that preference, business leaders apply continuous pressure on the trade agencies to expand the use of mutual recognition agreements.(134) While much lobbying occurs behind closed doors, visible examples of this pressure include TABD's maintenance of a scorecard of its detailed policy recommendations and its high profile deliveries of annual report cards on the government's progress in implementing TABD's objectives.(135)

The second consideration is that the European Union, eschewing full harmonization, appears to be interested in working with the United States only at the equivalence level. Past experiences of the EU member states show that achieving full harmonization is a challenging task, even among countries on a relatively similar level of development.(136) In addition, recent U.S.-EU conflicts over agricultural trade issues have tested the parties' relationship.(137) At this juncture, the United States and the European Union are much more likely to approach harmonization by using the easiest method possible in order to ensure cordial and mutually beneficial results. Of course, the European Union has held to full harmonization for environmental, health, and safety standards on an internal basis,(138) and it could eventually move the equivalence negotiations up to the level of full harmonization. However, the difficulties that the parties recently encountered in negotiating the U.S.-EC MRA suggest that such a move will be unlikely for some time to come.(139)

The third and perhaps most unavoidable consideration in choosing a method of harmonization is the requirements and recommendations of the TBT and SPS Agreements. In those agreements, the United States and other WTO member states agreed to begin the process of adjusting their sanitary and phytosanitary measures and technical regulations to become equivalent with international standards.(140) The SPS Agreement further mandates the application of equivalence to the harmonization of sanitary and phytosanitary measures of other member states under certain circumstances.(141) As international legal obligations, these WTO membership responsibilities compel the United States to employ equivalence regardless of whether or not it is appropriate.(142)

V. CONCLUSION

The question of how to achieve harmonization of standards between nations--by full harmonization or by equivalence--has a clear normative answer: full and upward harmonization must be pursued. Although upward harmonization is the more challenging method and may initially only be feasible between similarly developed nations, it is the only method that does not reduce regulatory protection from the levels chosen by different nations. That is, only full and upward harmonization can rectify trade imbalances that cause damaging spillovers while producing system-wide gains in health, safety, and environmental protection. Because of the danger of the back door effect, equivalence proves itself to be unsuitable for the multilateral harmonization of standards and should be reserved for harmonization of regulatory procedures in areas such as conformity assessment.

This inquiry into the dynamics of harmonization raises a related issue: How will the provisions of the TBT and SPS Agreements affect national health, safety, and environmental protection regimes once the push for harmonization moves past the initial obstacles? The future progress of harmonization will depend in large part on the discretion of the WTO member states. The language of the TBT and SPS Agreements is sufficiently flexible that the compliance of member states will likely vary from issue to issue depending upon the practicalities and political realities. Disputes, if they arise, will be few and far between because enforcement will only be undertaken at the request of a party. Generally, the benefits gained from enforcement are not worth the damage to economic interests that results from trade disputes pursued to the point of sanctions. While environmental protection is rarely the central goal of harmonization efforts, it can play a very important role in harmonization if the appropriate model is applied. In such an endeavor, even the language of the TBT and SPS Agreements may be enlisted in the service of enhancing health, safety, and environmental protections on a global scale.

(1) Herman E. Daly, The Perils of Free Trade, SCI. AM., Nov. 1993, at 50, 56.

(2) The Earth's population has grown from approximately 1.6 billion in 1900 to 6 billion today. U.S. Bureau of the Census, Historical Estimates of World Population (visited Mar. 11, 2000) <http://www.census.gov/ipc/www/worldhis.html>; U.S. Bureau of the Census, World POPClock Projection (Last modified Dec. 29, 1999) <http://www.census.gov/cgi-bin/ipc/popclockw>.

(3) Of the many indicators of damage to the environment, one of the most worrisome may be the depletion of the ozone layer, which protects terrestrial life from harmful ultraviolet radiation. According to the U.S. National Oceanic and Atmospheric Administration, the portions of the ozone layer above the United States and Europe were 10 to 20% less thick than normal during the winter of 1994-1995. NATIONAL OCEANIC AND ATMOSPHERIC ADMIN., NORTHERN HEMISPHERE WINTER SUMMARY 95/1: SELECTED INDICATORS OF STRATOSPHERIC CLIMATE 2-3 fig.3 (1995).

(4) For U.S. laws see, for example, the Endangered Species Act of 1973, 16 U.S.C. [subsections] 1531-1544 (1994) (regulating human actions that affect endangered species); the Federal Water Pollution Control Act, 33 U.S.C. [subsections] 1251-1337 (1994 & Supp. III 1997) (regulating discharges into navigable waters); the National Environmental Policy Act of 1969, 42 U.S.C. [subsections] 4321-4347 (1994 & Supp. III 1997) (regulating agency review of projects that affect the environment); the Resource Conservation and Recovery Act of 1976, 42 U.S.C. [subsections] 6901--6992k (1994 & Supp. III 1997) (amending Solid Waste Disposal Act, Pub. L No. 89-272, 79 Stat. 992) (regulating the disposal of solid and hazardous wastes); and the Clean Air Act, 42 U.S.C. [subsections] 7401-7671q (1994 & Supp. III 1997) (regulating air emissions), international efforts to protect humans and the environment are also visible in the creation of more than 800 multilateral environmental agreements since 1972. Edith Brown Weiss, International Environmental Law: Contemporary Issues and the Emergence of a New World Order, 81 GEO. L.J. 675, 679 (1993).

(5) See Alberto Bernabe-Riefkohl, To Dream the Impossible Dream: Globalization and Harmonization of Environmental Laws, 20 N.C.J. INT'L L. & COM. REG. 205, 208-09 (1995) (discussing the theory of free trade).

(6) Id.

(7) DAVID HUNTER ET AL., INTERNATIONAL ENVIRONMENTAL LAW AND POLICY 1181 (1998).

(8) General Agreement on Tariffs and Trade, Oct. 30, 1947, 61 Stat. A3, 55 U.N.T.S. 187.

(9) TREATY ON EUROPEAN UNION, Feb. 7, 1992, 1992 O.J. ((3 340) 145 (1997), 31 I.L.M. 247; TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY, Mar. 25, 1957, 298 U.N.T.S. 3 [hereinafter EEC TREATY]; Single European Act, 1987 O.J. (L 169) 1. The terms European Union (EU) and European Community, (EC) are used interchangeably in this Comment.

(10) North American Free Trade Agreement, Dec. 8 & 17, 1992, 32 I.L.M. 289.

(11) Trade and American Prosperity in 1999: Testimony before the United States Senate Committee on Finance, 106th Cong. 137 (1999) (testimony of Ambassador Charlene Barshefsky, United States Trade Representative).

(12) See DANIEL C. ESTY, GREENING THE GATT: TRADE, ENVIRONMENT, AND THE FUTURE 101 (1994) (discussing whether trade liberalization threatens environmental regulation); Richard J. King, Trade and the Environment: European Lessons for North America, 14 UCLA J. ENVTL. L. & POL'Y 209, 212-13 (1995/96) (discussing the impact of regional integration arrangements on environmental policy and trade liberalization).

(13) The international legal principle of state sovereignty holds that a state has the exclusive right to exercise legislative and judicial jurisdiction over its territory and citizens. HUNTER ET AL., supra note 7, at 326-27.

(14) ESTY, supra note 12, at 108.

(15) Id. at 101-02.

(16) See Bernabe-Riefkohl, supra note 5, at 211-12 (describing several trade problems resulting from differing environmental standards).

(17) King, supra note 12, at 212.

(18) Id. at 223.

(19) Bernabe-Riefkohl, supra note 5, at 211-12.

(20) See discussion infra Part II.

(21) Equivalence does not pose the same danger in the case of procedural standards. See discussion infra Part II.D.

(22) See discussion infra Part III.

(23) Agreement on Technical Barriers to Trade, Apr. 15, 1994, Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, 33 I.L.M. 1125 [hereinafter GATT 1994], pt. II, Annex 1A(6), reprinted in [1 TREATIES] LAW & PRACTICE OF THE WORLD TRADE ORGANIZATION 1, 135-60 [hereinafter TBT Agreement].

(24) Agreement on the Application of Sanitary and Phytosanitary Measures, GATT 1994, pt. II, Annex IA (4), reprinted in [1 TREATIES] LAW & PRACTICE OF THE WORLD TRADE ORGANIZATION, supra note 23, at 59-75 [hereinafter SPS Agreement].

(25) The WTO was created in 1995 by the Agreement Establishing the World Trade Organization, Dec. 15, 1993, 33 I.L.M. 13. Attached to this agreement are the operating provisions of the WTO, called GATT 1994. See GATT 1994, reprinted in [1 TREATIES] LAW & PRACTICE OF THE WORLD TRADE ORGANIZATION, supra note 23, bk. 1, 1-422. GATT 1994 subsumed the original GATT of 1947, along with a number of ancillary agreements. Bernabe-Riefkohl, supra note 5, at 205-06 n.3.

(26) See discussion infra Part III.C.

(27) See discussion infra Part III.A-B.

(28) Conformity assessment is the process by which products are measured for sufficiency against standards relating to product manufacture, processing, packing, safety, identity, quality, or purity. 15 C.F.R. [sections] 286.2 (1999). For examples of conformity assessment efforts, see the Agreement on Mutual Recognition Between the United States of America and the European Community, June 20, 1997, U.S.-EC, art. 1, Hein's No. KAV 5464, Temp. State Dep't No. 99-53, at 6 [hereinafter U.S.-EC MRA]. This agreement is reprinted at Office of the U.S. Trade Representative, USTR Agreements (visited Mar. 11, 2000) <http://www.ustr.gov/agreements/mra/mral.pdf>.

(29) WEBSTER'S NEW COLLEGIATE DICTIONARY 1148 (9th ed. 1989).

(30) For an example of mandatory standards, see the requirements for new medical devices established by the Food and Drug Administration (FDA). Guidance for the Recognition and Use of Consensus Standards, 63 Fed. Reg. 9561 (Feb. 25, 1998). In certain cases, federal regulations require agencies to use voluntary conformity standards that are already in place. See, e.g., 48 C.F.R. [sections] 11.101 (c) (1999) (describing agency methods for selecting and developing requirements documents). An example of a voluntary standards organization is the National Committee for Information Technology Standards (NCITS). NCITS "develops national standards and its technical experts participate on behalf of the United States in the international standards activities of ISO/IEC JTC 1, Information Technology." National Comm. for Info. Tech. Standards, General Information (visited Mar. 11, 2000) <http://www.x3.org/geninfo.htm>.

(31) WEBSTER'S NEW COLLEGIATE DICTIONARY, supra note 29, at 992. These definitions differ from those in the TBT Agreement, which idiosyncratically uses the term "standard" to denote only voluntary standards and uses the term "technical regulation" to denote mandatory standards. TBT Agreement Annex 1, paras. 1 & 2. An Annex note explains that its definition of "standard" differs from other international organizations' terms and definitions, which state that standards may be mandatory or voluntary. Id. Annex 1, para. 2. This Comment adheres to the conventional definitions of the terms.

(32) Examples of such international standard-setting organizations include the Codex Alimentarius Commission, a joint creation of the United Nations Food and Agriculture Organization and the World Health Organization; the International Office of Epizootics; and the Secretariat of the International Plant Protection Convention. World Trade Organization, SPS: Harmonization (visited Mar. 11, 2000) <http://www.wto/eol/e/wto03/wto3_26.htm>.

(33) See King, supra note 12, at 234 (noting that economic integration is the objective that has led the EU to harmonize environmental and other standards); see also Frederick M. Abbott, Regional Integration and the Environment: The Evolution of Legal Regimes, 68 CHI.-KENT L. REV. 173, 188-89 (1992) (analyzing the European Community's experience regarding trade and environmental policies).

(34) Bernabe-Riefkohl, supra note 5, at 209.

(35) See King, supra note 12, at 233-35 (discussing the European Community's integration experiences). For example, the harmonization of environmental standards can remove the incentive for manufacturers to relocate production to countries with lax standards. Id. Another purpose of harmonization can be to serve as a "solution" to the inherent conflict between free trade and protection of the environment. Id. at 228. Along those lines, Alberto Bernabe-Riefkohl writes that "environmental protection and the elimination of regional disparities through environmental and social cohesion" are included by the EU in its reasons for harmonization. Bernabe-Riefkohl, supra note 5, at 216. Nevertheless, the paramount motivation behind harmonization appears to be the enhancement of trade, with environmental protection mentioned only tangentially. Id. at 220-27.

(36) King, supra note 12, at 235.

(37) See HUNTER ET AL., supra note 7, at 1283; King, supra note 12, at 209.

(38) One of the earliest examples of harmonization in Europe is the standardization of European patent law. The harmonization process effectively began with the 1883 Convention for the Protection of Industrial Property (Paris Convention), as amended by the 1967 Stockholm Revision, July 14, 1967, 6 I.L.M. 806, and culminated in the 1973 Convention on the Grant of European Patents (European Patent Convention (EPC)), Oct 5, 1973, 13 I.L.M. 271, which established the European Patent Office (EPO). Each nation must harmonize its national patent law with the EPC in order to join the EPO. Harold C. Wegner, TRIPS Boomerang--Obligations for Domestic Reform, 29 VAND. J. TRANSNAT'L L. 535, 539-40 (1996).

(39) Jeffery Atik, Environmental Standards Within NAFTA: Difference by Design and the Retreat from Harmonization, 3 IND. J. GLOBAL LEGAL STUD. 81, 84 (1995); see also Bernabe-Riefkohl, supra note 5, at 215-17 (discussing the European Union's harmonization efforts, its limited results, and the inherent conflict between free trade and environmental protection, which demonstrates the need for a global approach to developing an environmental trade policy rather than developing regional policies); King, supra note 12, at 230 (discussing the European Union's amended harmonization policy that allows for mutual recognition among member states except for food, medicines, and potentially hazardous products that still remain under the original full harmonization policy).

(40) See discussion infra Part III. C.

(41) Richard A. Merrill, FDA and Mutual Recognition Agreements: Five Models of Harmonization, 53 FOOD & DRUG L.J. 133, 135-37 (1998) (suggesting five models of harmonization: the "agent-in-place" model, the enforcement discretion agreement, the "deputy sheriff" model, equivalence, and harmonization). Merrill's five models might be more accurately described as types of interagency arrangements for regulatory cooperation rather than as methods of harmonization. In the first three, the standards of the two countries are not actually harmonized. This Comment discusses the. remaining two models, which involve de facto and actual harmonization, respectively.

(42) See King, supra note 12, at 233-35.

(43) See John Audley, Why Environmentalists are Angry about the North American Free Trade Agreement, in TRADE AND THE ENVIRONMENT: LAW, ECONOMICS, AND POLICY 191, 194-97 (Durwood Zaelke et al. eds., 1993) (discussing environmentalists' fears that downward harmonization will impair enforcement of existing domestic environmental laws and restrict the ability of each nation to set higher standards than currently accepted by other nations).

(44) For a broader discussion of the trade-environment debate, see Bernabe-Riefkohl, supra note 5, at 205-13.

(45) King, supra note 12, at 230.

(46) Id.

(47) See Steve Charnovitz, Environmental Harmonization and Trade Policy, in TRADE AND THE ENVIRONMENT, supra note 43, at 267, 272; King, supra note 12, at 230.

(48) Merrill, supra note 41, at 136.

(49) Id. at 133.

(50) Id. at 136.

(51) See supra notes 45-46.

(52) Trade Agreements Act of 1979, 19 U.S.C. [subsections] 2501-2580 (1994 & Supp. IV 1998).

(53) Id. [sections] 2578(a) (1994).

(54) Id. [sections] 2502(2).

(55) Agreement on Technical Barriers to Trade, Apr. 12, 1979, 31 U.S.T. 405, 1186 U.N.T.S. 276 [hereinafter Standards Code]. The Standards Code was replaced in 1994 by the TBT Agreement, which converted the Standards Code's encouragement of harmonization into a requirement that member states actively pursue harmonization of technical standards, subject to limited exceptions. See TBT Agreement arts. 2.4, 2.6.

(56) See Bernabe-Riefkohl, supra note 5, at 213.

(57) See supra note 50 and accompanying text.

(58) See supra note 29 and accompanying text.

(59) See Merrill, supra note 41, at 136 (stating that equivalence would allow U.S. law to "be satisfied in multiple ways" and expressing uncertainty as to whether equivalence is viable under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. [subsections] 301-397 (1994 & Supp. IV 1998)).

(60) The likelihood that businesses will seek to use this back door is very high. In today's world, increased market accessibility and inexpensive transport sharpen global competition, which forces businesses to avail themselves of any such opportunities to evade costly regulation. See Bernabe-Riefkohl, supra note 5, at 226 (discussing the harmful effects--especially the tendency for promoting weaker common environmental standards between countries while striking down more stringent domestic environmental regulations--of allowing environmental regulations to be altered by international bodies lacking state representation).

(61) David A. Wirth, The Role of Science in the Uruguay Round and NAFTA Trade Disciplines, 27 CORNELL INT'L L.J. 817, 833 (1994).

(62) See id. at 833-34.

(63) See id. at 834-35.

(64) See, for example, the notice and comment provisions of the Administrative Procedure Act, 5 U.S.C. [subsections] 551-559, 701-706, 1305, 3105, 3344, 4301, 5335, 5377, 7521 (1994 & Supp. IV 1998).

(65) See Wirth, supra note 61, at 833.

(66) See EUROPEAN COMMISSION, WHITE PAPER: PREPARATION OF THE ASSOCIATED COUNTRIES OF CENTRAL AND EASTERN EUROPE FOR INTEGRATION INTO THE INTERNAL MARKET OF THE UNION [subsections] 2.18-2.19 (1995) (available online at <http://europa.eu.int/en/agenda/peco-w/en/index.html>); King, supra note 12, at 230.

(67) Committee on Transport and Tourism (94), Resolution on the Pan-European Transport Policy, 1996 O.J. (C 380) 78 (requiring "harmonization of environmental protection and safety standards at the highest European level of protection") (emphasis added). This indicates a strengthening of the original EU policy of harmonizing standards by taking "as a base a high level of protection." EEC TREATY art. 100a, para. 3. In addition, the Single European Act commits the European Union to "eliminating disparities in development among nations to avoid downward harmonization." Bernabe-Riefkohl, supra note 5, at 228.

(68) See discussion infra Part IV.

(69) See Kirk Kennedy, Deconstructing Protectionism: Assessing the Case for a Protectionist American Trade Policy, 28 CASE W. RES. J. INT'L L. 197, 198-99 (1996).

(70) See John Deane, Green Groups Alarmed at Prospect of New Trade Talks, PRESS ASS'N NEWSFILE, Jan. 29, 2000, available in Lexis, News Library, News Group File.

(71) Transatlantic Business Dialogue, TABD: Background (visited Jan. 28, 1999) <http://www.tabd.org/about/background.html>.

(72) Id.

(73) Joan Spero, The New Transatlantic Agenda: Setting the Course for U.S. Cooperation with Europe, Address Before the American Council on Germany (May 13, 1996), in U.S. DEP'T ST. DISPATCH, June 3, 1996, at 283, available in 1996 WL 10106148.

(74) Through a dedicated unit in the United States Department of Commerce, TABD has become "`deeply enmeshed and embedded into the US government decision-making process on a whole range of regulatory, trade, and commercial issues.'" John Audley & Amanda Johnson, Background Information on the Trans-Atlantic Business Dialogue (TABD) 6 (May 28, 1998) (unpublished manuscript, on file with author) (quoting Stuart Eizenstat, Under Secretary of State for Economic Affairs, May 23, 1996). Business leaders have achieved an enhanced level of influence on U.S. policy with the Clinton Administration's creation of an Interagency Task Force to manage implementation of TABD recommendations. Transatlantic Business Dialogue, TABD 1998 Mid-Year Scorecard Report (visited Dec. 2, 1999) <http://www.tabd.org/recom/scorecard.html>. The Clinton Administration has rebuffed petitions by environmental organizations asking for a comparable liaison unit to serve as a conduit for the concerns of civil society. In its place, the Administration has offered to initiate government-controlled environmental and consumer "dialogues," which are viewed skeptically by most organizations.

(75) Vice President Al Gore, Speech to the Transatlantic Business Dialogue Charlotte Conference (Nov. 6, 1998), in Transatlantic Business Dialogue, Vice President Gore Speech (visited Dec. 2, 1999) <http://tabd.org/resources/content/gore.html>.

(76) Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; Pharmaceutical GMP Inspection Reports, Medical Device Quality System Evaluation Reports, and Certain Medical Device Premarket Evaluation Reports, 63 Fed Reg. 17,744, 17,747 (Apr. 10, 1998); see discussion infra Part IV.A.

(77) Sharon Smith Holston, An Overview of International Cooperation, 52 FOOD & DRUG L.J. 197, 198 (1997). Ms. Holston is FDA Deputy Commissioner for External Affairs.

(78) Id. at 197.

(79) 63 Fed. Reg. at 17,746.

(80) Id.

(81) Holston, supra note 77, at 198.

(82) 63 Fed. Reg. at 17,746.

(83) HUNTER ET AL., supra note 7, at 1181.

(84) Id.

(85) SPS Agreement art. 1(1), Annex A(1).

(86) TBT Agreement arts. 1.5, 2.

(87) See discussion infra Part III. C.1-2.

(88) Administrative Procedure Act, 5 U.S.C. [subsections] 551-559, 701-706, 1305, 3105, 3344, 4301, 5335, 5372, 7521 (1994 & Supp. IV 1998).

(89) Industry and Consumer Exchange Meeting Concerning FDA and APHIS Activities on a Potential Agreement with the European Union Related to Human and Animal Drug and Biological Product Information; Notice of Public Meeting, 60 Fed. Reg. 15,934, 15,935 (Mar. 28, 1995) (giving notice of a public meeting for the purposes of explaining and receiving comments on U.S. exploration of a "potential" U.S.-EC MRA).

(90) See supra note 31 and accompanying text.

(91) See TBT Agreement arts. 2, 5 (explaining technical regulations and standards). Unhelpfully, the TBT Agreement defines neither harmonization nor equivalence.

(92) See id. art. 2.7.

(93) See id. art. 6.3.

(94) See discussion supra Part II.D. Additionally, once a member state has opted to recognize another's CAP as equivalent, Article 6.1 requires the recognition of the results of that CAP. TBT Agreement art. 6.1.

(95) Unlike Annex A(3) of the SPS Agreement, Annex 3 of the TBT Agreement does not specify exactly which international standard-setting bodies will provide the relevant standards, but it does assign a prominent role to the International Organization for Standardization. Compare SPS Agreement Annex A(3) (defining relevant terms used in the agreement), with TBT Agreement Annex 3 (discussing the appropriate preparation, adoption, and application of standards).

(96) TBT Agreement art. 2.4. Article 2.6 further aims to stifle the creation of differing national regulations by requiring that member states "play a full part ... in the preparation by appropriate international standardizing bodies of international standards." Id. art. 2.6. The resulting standards would then have to be incorporated into those member states' regulatory schemes under Article 2.4. See id. art. 2.4.

(97) See id. art. 5.4.

(98) Id. art. 2.4. In other words, a member state does not have to adopt an international standard if it differs so much from the national standard that it cannot achieve the latter's objectives. Because Article 2.2 includes the protection of "human health or safety, animal or plant life or health, or the environment" in its list of legitimate objectives, this exception might initially appear to allow a member state to easily escape the harmonization requirement. Id. art. 2.2. But this is not in fact the case. With respect to any given standard, the question of whether or not the exception applies could easily become a matter of dispute for resolution by a WTO dispute resolution panel. The potential costs to trade relationships of defending the application of the exception, even if the defense is successful, may deter its use.

(99) See id. art. 2.4.

(100) Environmentalists and scholars have criticized some international standards bodies as being nondemocratic, unaccountable, and dominated by industry. See ESTY, supra note 12, at 172-73.

(101) SPS Agreement art. 14, Annex

(102) See id. arts. 3(1), 4(1), 4(2).

(103) Id. art. 3(1).

(104) See id. art. 3(3).

(105) See id. art. 4(1).

(106) See id. art. 4(2)

(107) Id.

(108) See generally New European Community Testing and Certification Procedures: Opportunity for Interested Parties to Comment, 54 Fed. Reg. 37,967 (Sept. 14, 1989) (describing the activities of the U.S. Working Group on EC Standards, Testing, and Certification, and requesting comments on how the United States should respond to the European Union's plans for the harmonization of health and safety requirements for industrial products).

(109) See Council Resolution of 21 December 1989 on a Global Approach to Conformity Assessment, 1989 O.J. (C 136) 1-9 (laying out a new approach to technical harmonization and standards that is designed to remove technical barriers to trade); Commission Proposal for a Council Decision Concerning the Modules for the Various Phases of the Conformity Assessment Procedures Which Are Intended To Be Used in the Technical Harmonization Directives, 1989 O.J. (C 231) 3 (regarding a global approach to certification and testing and quality measures for industrial products); Council Resolution of 7 May 1985 on a New Approach to Technical Harmonization and Standards, 1985 O.J. (C 136) I (discussing a global approach to conformity assessment).

(110) U.S., EC Seek to Harmonize Manufacturing Standards, WALL ST. J., June 24, 1991, at A12 (reporting the release of a joint communique from U.S. Secretary of Commerce Robert Mosbacher and European Community Commission Vice President Martin Bangemann announcing that the United States and the European Community had agreed to step up their efforts to harmonize industrial standards in order to remove technical barriers to trade). See generally Request for Comments on a Proposal to Establish the Conformity Assessment Systems Evaluation Program (CASE), 57 Fed. Reg. 10,620 (Mar. 27, 1992) (outlining United States Department of Commerce plans to establish a Conformity Assessment Systems Evaluation Program within the National Institute of Standards and Technology, pursuant to the objectives stated in the Mosbacher-Bangemann communique).

(111) U.S.-EC MRA, supra note 28; see also Fred Brown, European Union's Voice Being Heard at Summit Table, DENVER POST, June 22, 1997, at AA6.

(112) See U.S.-EC MRA, supra note 28, art. 2, at 7.

(113) See id. art. 21, at 25.

(114) See id. art. 2, at 7.

(115) This system of conformity assessment by proxy, in which the United States allows another country's regulators to verify compliance with U.S. standards and vice versa, is an example of regulatory cooperation on the basis of what Richard Merrill calls the deputy sheriff model. See Merrill, supra note 41, at 136-37. In contrast, the MRA itself, which creates the cooperative system just described, operates on the equivalence model in its harmonization of the U.S. and EC conformity assessment procedures.

(116) See id. at 136.

(117) Ralph Ives, Briefing on MRAs for Representatives of Nongovernmental Organizations, Washington, D.C. (Mar. 14, 1997). However, the highly amendable nature of the MRA means that it may easily be changed to apply to standards. See infra note 122 and accompanying text.

(118) Regarding the back door effect, see discussion supra Part II.D. An issue not discussed here is whether equivalence of conformity assessment procedures should be used to allow foreign regulatory authorities to do new product approvals, testing of production of preapproved products, or only quality system evaluations. The medical devices sectoral, for example, appears to allow some degree of product approval. See U.S.-EC MRA, supra note 28, Sectoral Annex on Medical Devices arts. 2, 3, at 7-8.

(119) Of court, a decision by U.S. regulators to recognize another country's conformity assessment bodies and procedures as equivalent to those of the United States does not guarantee that those assessment bodies will apply U.S. standards as strictly or effectively as do U.S. regulators.

(120) U.S.-EC MRA, supra note 28, art. 4(3), at 9.

(121) Id.

(122) See id. art. 21(2), at 25. The Joint Committee is the administering body for the MRA, and it is composed of "representatives of each Party." Id. art. 14(1), at 19. Disturbingly, the text is unclear as to whether these representatives are to be regulatory officials or trade officials. See id. Because most of the sectorals have a Joint Sectoral Committee on which the regulatory officials sit, it is likely that the JC will be staffed with trade officials. As a result, trade officials will have the ability to expand the scope of the MRA to equivalence of standards at any time, without approval from regulatory officials or Congress.

(123) Although the U.S.-EC MRA was signed in June 1997, it did not officially come into force until December 1, 1998. U.S./EU Manufacturing MRA Requires "Confidence Building," TAN SHEET, Dec. 7, 1998, available in 1998 WL 17056972; Amy Zuckerman, Sino-US Workshops on Conformity Assessment Seek to End Trade Barriers, J. COM., Jan. 27, 1999, at 7A, available in 1999 WL 6370961.

(124) U.S./EU Manufacturing MRA Requires "Confidence Building," supra note 123; see also FDA Resource Allocations for MRA's Device Annex to Be Scrutinized by GAO, GRAY SHEET, Jan. 4, 1999, available in 1999 WL 10788383 (discussing a request for expanding the inquiry into FDA's implementation of the U.S.-EC MRA); Lisa Seachrist, Agreement with Europe at Issue: House Dems Concerned over Drug Inspection Pact, BIOWORLD TODAY, Jan. 4, 1999, available in 1999 WL

7737814 (discussing the implementation of the U.S.-EC MRA).

(125) In addition to the U.S.-EC MRA, U.S. trade officials have conducted successful MRA negotiations with the countries of the Asia-Pacific Economic Cooperation (APEC) forum, yielding an MRA for telecommunications equipment in June 1998. U.S. Department of Commerce, APEC Telecommunications MRA (visited Mar.11, 2000) <http://199.185.106/tcc/data/commerce_html /TCC_Documents/APECTelecom.html>.

(126) See Bernabe-Riefkohl, supra note 5, at 208-09.

(127) U.S.-EC MRA, supra note 28, art. 21(2), at 25.

(128) See EU Moves on U.S. Marine Products, LLOYD'S LIST INT'L, Jan. 9, 1999, available in 1999 WL 6175797.

(129) Richard Lawrence, A Summit with a Banana Split, J. COM., Dec. 14, 1998, available in 1998 WL 20947384; Transatlantic Business Dialogue, supra note 74.

(130) See Transatlantic Business Dialogue, supra note 74 (asserting that the United States and the European Union should sign an MRA on chemical good laboratory practices and mutual acceptance of data, building on the practice of the Organization for Economic Cooperation and Development in this field).

(131) See discussion supra Part IV.A.

(132) See discussion supra Part III.

(133) See Transatlantic Business Dialogue, supra note 74 (proclaiming TABD's support for mutual recognition and convergence).

(134) See discussion supra Part III.A.

(135) See discussion supra Part III.A.

(136) See discussion supra Part II.B. In the broad spectrum of development that characterizes the global arena, the existence of even greater disparities in standards makes full harmonization much more unlikely. As arguably the most affluent country in the world, the United States's health, safety, and environmental standards are generally higher than all but a few countries. If the United States were to pursue full harmonization, in most cases it would have to convince the other party to raise its standards. One possible technique for facilitating this process involves using funding assistance and technology transfer arrangements as incentives. The Montreal Protocol Multilateral Fund, which helps developing countries meet their obligations under the Vienna Convention for the Protection of the Ozone Layer, is a model for this approach. See generally Protection of the Ozone Layer Convention, Mar. 22, 1985, 26 I.L.M. 1529 (1987) (entered into force Sept. 22, 1998).

(137) In recent years, the United States and the European Union have been embroiled in a long-simmering trade conflict over import restrictions on bananas from certain regions and on U.S. beef injected with hormones. Paul Magnusson, This Banana War Is No Laughing Matter, BUS. WK., Mar. 22, 1999, at 39.

(138) See supra notes 66-67 and accompanying text.

(139) See supra notes 123-24 and accompanying text.

(140) See SPS Agreement art. 3(1); TBT Agreement arts. 2.4, 5.4; see also discussion supra Part III.C.

(141) See SPS Agreement art. 4(1)-(2) (providing that member states shall enter into equivalence negotiations regarding specified sanitary or phytosanitary measures upon request).

(142) The WTO Agreements constitute an international treaty subject to the Vienna Convention on the Law of Treaties, May 23, 1969, 1155 U.N.T.S. 331, and general principles of international law. See HUNTER ET AL., supra note 7, at 1204-05.

ALEXANDER M. DONAHUE, Associate Editor, Environmental Law, 1999-2000; J.D. expected 2000, Northwestern School of Law of Lewis & Clark College; B.A. 1993, University of California at Santa Barbara The author would like to thank Rod Leonard of the Community Nutrition Institute, Washington, D.C., for sparking the inquiry that resulted in this Comment. He would also like to express his appreciation to the staff of Environmental Law for their comments and editing assistance.