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The Triennial Review of the World Trade Organization on the Application of Sanitary and Phytosanitary Measures (The "SPS Agreement") Comments of Public Citizen, Inc.

January 9, 1998

Public Citizen submits these comments in response to the Office of the United States Trade Representative's request for comments with respect to the review by the World Trade Organization (WTO) Committee on Sanitary and Phytosanitary Measures (the "SPS Committee") of the Agreement on the Application of Sanitary and Phytosanitary Measures (the "SPS Agreement"), 62 Fed. Reg. 64618 (December 8, 1997). These comments focus on our concerns that the SPS Agreement does not adequately safeguard a country's right to adopt and implement regulations to protect human, animal and plant life or health, and to establish the level of protection of life and health that it deems to be appropriate. Indeed, the first WTO decision applying the SPS Agreement -- EC Measures Concerning Meat and Meat Products (Hormones) -- vividly illustrates how the SPS Agreement can be an obstacle to governments' exercise of their right to take action to protect against risks to human health. The upcoming review of the SPS Agreement should carefully consider how the SPS Agreement was interpreted in the Meat Hormones case and include efforts to strengthen the ability of governments to maintain high standards of public health and environmental protection.

The Interests of Public Citizen

Public Citizen, founded by Ralph Nader in 1971, is a non-profit consumer advocacy organization with over 120,000 active supporters nationwide. Since its founding, Public Citizen has worked to strengthen the ability of citizens to participate in the domestic policy-making process and has worked to improve consumer health and safety. For the past six years, Public Citizen has worked to educate the American public about the enormous impact of international trade and economic globalization on our nation's health, safety and environmental standards, democratic accountability, and policy-making procedures. We submit these comments to ensure that the SPS Agreement does not result in diminishing the quality of our food or in reducing the level of health or environmental protection for Americans.

The SPS Agreement's Impact on Health and Safety

We have included with this submission our comments to the Appellate Body of the World Trade Organization spelling out our objections to the Panel's decision in the Meat Hormones case.(1) The comments detail our analysis of how the SPS Agreement should be implemented and how the WTO Panel's decision undermines countries' sovereign prerogatives to protect their citizens. We ask that the issues raised in our comments to the Appellate Body be given serious consideration by the SPS Committee in its triennial review of the implementation of the SPS Agreement.

The Meat Hormones decision demonstrates how the SPS Agreement can undermine countries' health, safety and environmental standards when trade challenges are initiated. Another example of the SPS Agreement's impact involves its chilling effect on strong standards, such as on a planned ban of the carcinogenic fungicide called Folpet. Six weeks after the WTO went into effect, U.S. and foreign chemical and agribusiness companies protested an EPA plan to ban all products containing residues of Folpet. As is standard practice, EPA was seeking comment during a review of "orphan" food residue tolerances for banned pesticides. Use of Fopet was banned in the United States because of its carcinogenicity and its registration was pulled in 1988. When EPA asked for comments as to why any Folpet food residue tolerances should be maintained, it received numerous petitions. One filing after another stated that under the WTO, the United States is not allowed to have a food standard stronger than Codex's international standards unless the United States can meet a certain scientific showing. Yet, one reason why Folpet's registration was pulled in 1988 was the unwillingness of the company producing it to provide EPA with data to prove it safe. Thus, without the industry's scientific information, the EPA is not able to meet the WTO data requirements. EPA's proposal to ban all products containing Folpet residues was stalled to allow for negotiations with Folpet's producer over obtaining the needed data. To date, no further action has been taken on the plan.

In addition to our specific concerns with the implementation of the SPS Agreement as revealed in the WTO's Meat Hormones decision and with its chilling effect on the enactment of strong safety standards, we also urge the SPS Committee to consider our more general concerns about how the SPS Agreement impairs the ability of the United States to protect its citizens against health risks.

First, the SPS Agreement should not be implemented in ways that discount the precautionary principle. The precautionary principle requires proof of safety before a product with a potential risk is allowed on the market, rather than requiring proof of danger before a product is banned. Indeed, under customary international law, countries have the right to regulate activities and substances that may be harmful to human health even if no conclusive or overwhelming evidence is available as to whether the activity actually causes that harm, the precise degree of harm or the process by which it occurs. The precautionary principle is based on the premise that science does not always provide the information or insights necessary to take protective action effectively or in a timely manner and that undesirable and potentially irreversible effects may result if action is not taken until science does provide such insights.

For example, by taking precautionary steps with respect to possible risks from the use of thalidomide, the United States avoided a potentially disastrous epidemic of birth defects. In the 1950s, thalidomide was discovered to be a very effective sedative and anti-emetic. Tests in laboratory animals showed no negative effects. As a result, thalidomide became a favorite non-prescription sleep-aid in West Germany and elsewhere, even being sold in a liquid form for children, and was used by pregnant women to prevent nausea. In subsequent years, however, some long-term users of the drug began complaining of neurological problems.

At about the same time, FDA was considering an application for approval of thalidomide for use in the United States. An FDA scientist familiar with the fact that drugs can affect fetuses and newborns completely differently from adults learned about the reports of possible side-effects associated with long-term use of thalidomide and became concerned over the proposed use of the drug to prevent nausea during pregnancy. She therefore requested more data to show that the drug was safe during pregnancy. Before the manufacturer of the drug could provide such information, reports arrived from Europe noting an alarming increase in the number of babies born with limb-reduction deformities and a Canadian doctor reported that such effects might result from the use of thalidomide during pregnancy. Although the precise mechanism by which thalidomide affected fetuses was not understood -- in fact, the mechanism remained unclear into the 1980s -- FDA took a precautionary approach and refused to approve the use of thalidomide in the United States.

Thalidomide is estimated to have been responsible for deformities in more than 10,000 babies in the countries in which it was approved. Through its precautionary action, the FDA prevented a similarly devastating experience in the United States. It is imperative that the SPS Agreement not become an obstacle to a country's use of the precautionary principle in setting health and safety standards.

Second, the SPS Agreement exalts the role of science far beyond the point it is appropriate, attempting to eliminate all "non-science" factors from standard-setting. Despite the value of science in policy-making, scientific uncertainties concerning the health threats posed by exposure to chemicals remain. Moreover, political judgments play a central role in policy-making. While science plays a valuable role in informing such policy decisions, it is ultimately Congress or a state legislature that must make the political decision about how much risk society will face under a food safety law. Thus, Congress may make the political decision to allow zero risk from a particular hazard, rather than establishing an allowable level of risk. For example, the United States has a zero tolerance level for listeria in cold smoked fish, canned lobster and ready-to-eat seafood combined with a more rigorous sampling regime than that currently practiced in Canada. Canada considers the U.S. policy to be unnecessarily severe and thus, listed the listeria policy in its 1996 Register of United States Barriers to Trade.

Or, Congress may decide under the notion of the precautionary principle, not to allow exposure to a substance until it has been proved safe, rather than allowing unregulated exposure until there is conclusive scientific evidence that the substance is harmful. The SPS Agreement thus may jeopardize cutting-edge food safety regulation in areas, such as food irradiation and biotechnology, where the scientific evidence is not yet in, but a country wishes to protect its citizens from possible, but uncertain, harm under the precautionary principle.

Third, the SPS Agreement requires standards to be based on risk assessment. The foundation of risk assessment is the notion that scientists can accurately predict the consequences of a numerous and ever-expanding list of different food additives all interacting in the human body. In fact, scientists will never be able to make these determinations. For this reason, many scientists, regulators and consumer and environmental organizations are calling for public health policies that prevent such exposures in the face of scientific uncertainty and reduce the toxic load in food. However, by requiring food safety standards to be based on a risk assessment, the SPS Agreement eliminates the possibility that a society's values -- for example, prevention of exposure to a highly toxic substance in the presence of uncertain knowledge of the chemical's effects on humans at low doses -- should outweigh the uncertain outcome of a risk assessment.

Moreover, risk assessments can be no better or more accurate than the data on which they are based. Yet, most of the data on emerging toxins, like E-coli H:157, is poor; and therefore, the risk assessments are poor as well.

Fourth, the SPS Agreement's provisions on harmonization and equivalence threaten to force the United States to lower health, safety and environmental standards and to accept imported products that do not meet our high standards. By requiring U.S. standards to be based on international ones, and establishing an entirely separate set of rules applicable only to those rules that provide greater public health protection than international standards, the SPS Agreement creates strong incentives to avoid exceeding international standards. The international standards serve as a ceiling, not a floor, curtailing innovative solutions to public health problems that are ahead of the international status quo, but not requiring that any solutions be put into place. In other words, the SPS Agreement contains no incentives, let alone any mandates, that countries, at a minimum, afford the level of protection provided by relevant international standards. Such downward harmonization has alarming public health consequences. International standards are generally developed in secret with extensive industry input, but no public oversight or participation. Thus, they are often weaker than U.S. standards.

Public Citizen and the Environmental Working Group published an extensive study, Trading Away U.S. Food Safety (April 1994), on the Uruguay Round's implications for U.S. food safety that closely analyzed Codex standard-setting procedures and compared some Codex standards to U.S. standards in the area of pesticides. In summary, that study found that the Codex pesticide standard-setting process is poorly suited to the task of setting presumptively correct international pesticide standards because: Codex's public health mission has lagged behind its trade agenda: Codex operates with extensive influence from the chemical and food industries and little consumer, environmental or public input; Codex has no minimum requirements for the content and completeness of the data sets that it uses to establish allowable levels of pesticides on food; Codex does not assess human dietary exposures to pesticides in different countries when establishing tolerance for pesticides in international commerce; and Codex uses a generally less protective standard-setting process than the United States to regulate carcinogens. None of our findings or concerns about Codex have been reduced in the years since our study was released.

Finally, we recommend that USTR conduct research to assist in the review of the SPS Agreement's impact on the health and safety standards of the United States. In particular, we recommend that USTR take the following three actions:

(1) USTR should identify particular federal and state standards which may be vulnerable to challenge under the WTO's interpretation of the SPS Agreement in the Meat Hormones case.

(2) USTR should gather information on the chilling effect the SPS text may have on proposed state or local laws. We are concerned that threats of trade challenges may be preventing stronger consumer protections, like the EPA's ban on Folpet, from being enacted.

(3) USTR should review its process for how the United States decides to go forward with a trade challenge under the SPS Agreement, and incorporate public participation into the process. For example, USTR should publish a Federal Register notice for comment before launching a WTO challenge.


The review of the SPS Agreement should begin with a careful look at the first WTO decision applying the SPS Agreement in the Meat Hormones case and how the decision exemplifies the dangers of the SPS Agreement. The focus of SPS Committee's trienniel review should be to ensure that implementation of the SPS Agreement is not jeopardizing the ability of the United States and other countries to establish strong health, safety and environmental standards.

Respectfully submitted,

Lucinda Sikes
Staff Attorney
Public Citizen Litigation Group
1600 20th Street, N.W.
Washington, D.C. 20009


1. The comments were submitted by the Earthjustice Legal Defense Fund on behalf of Public Citizen, Institute for Agriculture and Trade Policy, Cancer Prevention Coalition, and Community Nutrition Institute on October 31, 1997.

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