The Impact of Harmonization on U.S. Food Standards

Statement by Lucinda Sikes at the
21st Annual National Food Policy Conference
March 24, 1998

Good Afternoon. I am Lucinda Sikes, a staff attorney with Public Citizen Litigation Group, and a part of Public Citizen's efforts to ensure that international trade agreements do not undercut domestic health, safety and environmental laws. Public Citizen is a not-for-profit consumer advocacy group founded by Ralph Nader in 1971, with approximately 120,000 supporters nationwide. Since its founding, Public Citizen has worked to strengthen the ability of citizens to participate in the domestic policy-making process and to assure the safety of the nation's food supply. 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 are concerned that the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) adopted in 1994 during the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) impairs the ability of the United States to protect its citizens against health risks.

The SPS Agreement jeopardizes U.S. food safety standards in three related ways:

(1) by creating strong incentives for downward harmonization to weaker standards;

(2) by exalting the role of science and discounting the precautionary principle; and

(3) by requiring the United States to accept imports that do not meet our standards, but that are "equivalent."

First, under the SPS Agreement, U.S. food safety standards that exceed international standards, like those set by the Codex Alimentarius Commission (Codex), may be challenged as trade barriers. While the SPS Agreement does not require the United States to adopt international standards as national standards, it does require us to have a scientific justification to establish or maintain a more stringent standard. The SPS Agreement creates strong incentives to avoid setting a standard higher than an international one by requiring U.S. standards to be based on international ones, and by establishing an entirely separate set of rules applicable only to those rules that provide greater public health protection than international standards. Thus, 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.

We are particularly concerned by this requirement because international standards are generally developed in secret with no or very little public oversight or participation. And, certainly without the public accountability features offered in the United States by the Administrative Procedures Act and the Federal Advisory Committee Act. Thus, international standards are often weaker than U.S. standards. Bruce Silverglade from CSPI gave you some examples.

In addition to those examples, 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. 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.

Another example of the SPS Agreement's impact involves its chilling effect on strong standards. For example, EPA planned to ban residues of the carcinogenic fungicide called Folpet. Use of Folpet was banned in the United States because of its carcinogenicity and its registration was pulled in 1988. In 1994, as is standard practice, EPA was seeking comment on its plan to ban all products containing residues of Folpet during a review of "orphan" food residue tolerances for banned pesticides. 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 SPS Agreement, 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 that the company producing it had failed to provide EPA with data to prove it safe. Thus, without the industry's scientific information, the EPA is not able to meet the SPS Agreement's 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.

We are concerned that threats of trade challenges may be preventing stronger consumer protections, like the EPA's ban on Folpet, from being enacted.

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. Thus, the SPS Agreement allows a country to have a higher standard than an international standard, but only if the country has a "scientific justification."

Of course, science is important in standard-setting, but at the same time, scientific uncertainties concerning the health threats posed by exposure to toxic substances remain. And, 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, we may in the United States make the political decision to allow zero risk from a particular hazard, rather than establishing an allowable level of risk. So, 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 has 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 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.

The SPS Agreement's requirement for a scientific justification may jeopardize cutting-edge food safety regulation in areas, such as food irradiation and biotechnology, where the scientific evidence is not yet exhaustive, but a country wishes to protect its citizens from possible, but uncertain, harm under the precautionary principle.

In addition, 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. That's why many scientists and regulators 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.

Third, the SPS Agreement requires the United States to permit imports that do not comply with our own food safety standards where they satisfy different, but "equivalent" standards or processes. The SPS Agreement's concept of equivalency calls for a subjective comparison of different standards without any clear guidelines for how a country will determine whether a foreign standard or regulatory system is equivalent.

Both FDA and USDA have recently begun the process of establishing criteria they will use in evaluating whether the regulatory systems used by foreign countries to ensure the safety of foods exported here are equivalent to the regulatory system of the United States. Public Citizen has submitted comments to both agencies.

Making equivalence decisions without exacting review of both the substance of foreign standards and how foreign regulatory systems are implemented poses a significant risk of harm to public health and safety in the United States. "Equivalence" between U.S. and foreign standards should be found only in those circumstances in which a foreign standard or procedure meets or exceeds the level of public health protection, enforceability, and effectiveness of the U.S. standard. An erroneous determination of equivalence will lower the safety and quality of our food supply and expose the American public to an increased risk of harm, as demonstrated by the experience with USDA's earlier determination of equivalence for Canadian meat inspection procedures. Under the U.S.-Canada Free Trade Agreement, USDA decided that Canadian meat inspection procedures were equivalent to ours, even though the U.S. tests end products for listeria contamination, while Canada regulates the work environment in which the food is processed and Canada does not control or test for drugs approved for use in Canada but not in the United States. Meat imports were allowed into the United States under a cursory reinspection system. The General Accounting Office charged that the documentation did not support the conclusion that Canadian meat inspections were equivalent to the U.S. system, and meat inspectors complained that Canadian producers were taking advantage of the cursory reinspection and shipping contaminated meat.

The next big equivalence fight here concerns Australia's efforts to have its industry-inspected meat declared equivalent to meat produced domestically under USDA standards, which are predicated on a government, not industry, inspection program. Yet third-party inspections are not equivalent to government inspections because company-hired inspectors face a serious conflict of interest between protecting food safety and promoting the business interests of the company that hired them. Food inspectors routinely make judgment calls that are essential to protect the public health, but that also may have a negative impact on company production and profitability by, for example, slowing or stopping a production line or by prohibiting food from being sold. Government inspectors have a mandate to put the public's safety above all else, while company-hired inspectors' food safety role can be compromised by their dependence on the company for continuing employment. For this reason, Australia's proposal does not offer the same level of protection as the U.S. system and should be rejected.

Not only must the substance of a foreign standard meet or exceed the level of protection offered by the U.S. standard, but we must also look at the foreign regulatory system itself. For example, we must ensure that the foreign country allows public access to information about its regulatory activities so that the public can conduct an independent verification of on-going equivalence.

A key element of the U.S. regulatory system that ensures consumer confidence in the safety of our food is the public's ability to obtain access to information about the enforcement activities of agencies like USDA and FDA. In order for U.S. consumers to maintain confidence in the safety provided by an "equivalent" sanitary measure, the foreign system must allow public access to information about its regulatory activities -- either through mechanisms readily accessible to U.S. consumers through the foreign government or through the U.S. government -- so that U.S. consumers can verify that the foreign government's activities prevent adulterated products from being exported into the United States. The Freedom of Information Act ("FOIA") is an important safeguard to assuring that our food supply is safe because it allows the American public and press to find out what agencies like USDA and FDA are up to and to hold our public officials accountable for their actions. No equivalence determination should be reached unless the foreign system allows the public independently to verify adequacy through a FOIA-type procedure.


The SPS Agreement puts tremendous pressure on federal agencies to move toward uniform global standards through international standard-setting and equivalence determinations. The counter pressure to this is our domestic, democratically-accountable policy making process. If United States citizens are to continue to have a role in development of the standards governing the safety of the foods we eat -- as we must, under our domestic laws -- agencies must notify us and offer us the opportunity to comment on policy proposals as they are being developed, not after the fact. We must continue to put pressure on agencies to include us in the process, and I urge each of you to participate.

Thank you.