CSPI International
Center for Science in the Public Interest

Diet & Health/Food Labelling & AdvertisingFunctional FoodsFood Safety StandardsIACFOCodex Alimentarius CommissionWorld Trade OrganizationNAFTAGeneration ExcessSafe Food International

December 10, 1997

Dr. Edward Scarbrough
Manager, U.S. Codex Office
United States Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250-3700

Re: U.S. Position on Codex "Proposed Draft Guidelines for the Development of Equivalence Agreements Regarding Food Import and Export Inspection Certification Systems (at Step 4)," Sixth Session, Melbourne, Australia, February 23-27, 1998.

The Center for Science in the Public Interest (CSPI) submits these comments regarding the United States' position on the Development of Equivalence Agreements Regarding Food Import and Export Inspection Certification Systems.

We believe that it is premature for the U.S. to advocate international guidelines on equivalence determinations because the Food and Drug Administration (FDA) has not yet responded to public comments it has received from its Federal Register notice on domestic Guidance on Equivalency Criteria for Food. In addition, the U.S. Department of Agriculture (USDA) is planning, but has not yet held, additional hearings on equivalence determinations. Furthermore, the entire Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) is scheduled for review, and the Office of the U.S. Trade Representative plans to seek public comment. The U.S. government should not take positions internationally in policy areas that are subject to uncompleted domestic administrative proceedings. However, in the event that the U.S. proceeds with supporting the further development of Codex guidelines in this area, we believe that a series of modifications needs to be made to the draft U.S. position.

I. The language of the guideline should reflect the intent of the SPS Agreement that each country retains the right to set its own level of protection.

In 1994, the Congress approved the SPS Agreement. Article 4 of the SPS Agreement is intended to facilitate the free trade of food products by requiring signatories to the Agreement to recognize regulatory systems of other countries that are "equivalent to their own." Notwithstanding the Agreement's aim of harmonizing international requirements for food, the SPS makes clear that each country has the right to set its own level of protection.

The SPS reaffirms that:

  • no Member should be prevented from adopting or enforcing measures necessary to protect human, animal, or plant life or health, subject to the requirement that they are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members. . .

  • The Agreement then states that while its purpose is "to further the use of harmonized sanitary and phytosanitary measures between Members," it aims to do so "without requiring Members to change their appropriate level of protection of human, animal or plant life or health . . ."
Article 2 specifically recognizes the ability of members to "introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines, or recommendations, if there is a scientific justification. . ." The agreement explains that scientific justification exists if:

on the basis of an examination and evaluation of available scientific information in conformity with the relevant provisions of this Agreement, a Member determines that the relevant international standards, guidelines, or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection.
Article 4 of the Agreement, governing equivalence, must be read in light of these provisions. The proposed draft guidelines, however, do not take this crucial language into account. The guidelines do not reflect the fact that an importing country may reject a product as not being equivalent because "a Member determines that the relevant international standards, guidelines, or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection." We strongly recommend that this crucial point be reaffirmed in the proposed guidelines.

II. The U.S. should support the Codex guidelines only if they ensure that equivalence determinations will be consistent with U.S. law.

In passing the enabling legislation for the SPS Agreement, Congress precluded the FDA from modifying its regulations in response to the requirements of the SPS Agreement unless it provides the public with notice and an opportunity for comment. Furthermore, the FDA may not issue a final equivalency determination "without taking into account the comments received." To the extent a modification requires changes in the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA must seek Congressional authorization.

Congress specified that the FDCA is to prevail in the event of any conflict with the Uruguay Round Agreements. Congress expressly stated that:

Nothing in this Act shall be construed -- to amend or modify any law of the United States, including any law relating to -- (I) the protection of human, animal, or plant, life or health . . . unless specifically provided for in this Act.

In passing this legislation, Congress adopted a Statement of Administrative Action that explicitly states that the FDCA is not amended or modified by the legislation implementing the Uruguay Round. The Statement of Administrative Action explains that Section 102(a) of the implementing legislation "reflects the Congressional view that necessary changes in federal statutes should be specifically enacted rather than provided for in a blanket preemption of federal statements by those agreements." The Statement further provides that:

Accordingly, it is the expectation of the Administration that no changes in existing federal laws, rules, regulations, or orders other than those specifically indicated in the implementing bill and this Statement will be required to implement the new international obligations that will be assumed by the United States under the Uruguay Round agreements. Should it prove otherwise, the Administration would need to seek new legislation from Congress or, if a change in regulations is required, follow normal agency procedures for amending regulations.
Thus, although the SPS Agreement places pressure on the FDA to harmonize U.S. standards with those adopted by Codex and to declare other nations' regulatory schemes "equivalent," the FDA may not take any action that would violate the terms of the FDCA. Nor may the FDA take any action to modify regulations without providing notice and comment.

Therefore, the FDA must keep in mind that its Congressional mandate has not changed: its primary mission is to protect the health of consumers. The drafting of this comment, however, suggests that the FDA, in attempting to juggle the dual obligations of protecting health and promoting trade, may be compromising the former.

III. The draft U.S. position must be modified to meet the intent of Congress in passing the SPS Agreement and to ensure consistency with the Federal Food, Drug, and Cosmetic Act.

We support FDA's attempt to ensure that portions of the draft Codex guidelines are consistent with the agency's statutory authority. For example, we support the proposed requirement that the public be provided an opportunity to comment on the basis of equivalency determinations.

In other areas, however, the draft guidelines fall far short of meeting both the letter and the spirit of the law. For example, in the section of the proposal setting forth priorities that countries may wish to consider when determining whether to establish an equivalency agreement, the FDA lists whether an equivalency agreement would facilitate trade as the first priority. Public health risks come second. The FDA should take immediate steps to reorder these provisions so that public health, not merely trade concerns, rank as the number one priority for establishing equivalency agreements.

Furthermore, the guidelines must recognize that food safety laws are only one aspect of an exporting country's regulations that need to be considered before making an equivalency determination. Production of safe food can be dependent on a combination of many factors including water, air and soil quality, climate, transportation infrastructure, and overall sanitation conditions, such as water treatment. In addition, food borne pathogens may be different in different regions. Such considerations may dramatically increase the possibility of importing adulterated and misbranded foods and spreading food borne illness from one region to another.

The U.S. should also ensure that the guidelines specify that only official government agencies responsible for public health protection can enter into equivalency agreements. Although the guidelines refer to "competent authorities," the guidelines do not specify that such authorities may only be the appropriate officials from a government agency with jurisdiction over the safety and purity of the product at issue.

To ensure that equivalency is being maintained once an agreement is signed, the guidelines should specify that monitoring should occur every two years, unless problems are detected that warrant more frequent scrutiny. Under the proposed language, audits could occur as infrequently as every 10 years, which is clearly insufficient to protect the public health. Furthermore, equivalency agreements should remain in effect for only five years, unless they are renewed by mutual agreement.

To ensure that renewals do not occur on a pro forma basis, the Codex guidelines must specify that signatories to equivalency agreements must notify the public annually of all products that have been imported pursuant to an equivalency determination. The guidelines should also specify that the public be provided with a summary of the results of the monitoring of such agreements. The costs and benefits of establishing, monitoring, and renewing equivalency determinations should also be made available to the public for comment.

We support the FDA's decision to permit importing countries to audit potential exporters to assess the level of protection. However, it is crucial that the guidelines specify that government authorities have access to records and facilities that is comparable to what the U.S. can inspect domestically.

The Codex guidelines should also ensure that equivalence determinations are subject to peer review by independent scientific experts when significant health, safety, or policy issues arise. Although the proposed guidelines call for public comment on the basis for equivalence determinations, the failure to specify a requirement for peer review by independent experts could greatly undermine the credibility of specific equivalence determinations.

Equivalency agreements should also be subject to trial periods before being made final. Based on the experience that the U.S. has gained in implementing the U.S.-Canada Free Trade Agreement (USCFTA), it is clear that it is easy for important considerations to be overlooked when making an equivalence determination. For example, the General Accounting Office strongly criticized a USDA determination that the Canadian meat inspection system was equivalent to the U.S. system. U.S. meat inspectors complained that Canadians were taking advantage of the agreement and shipping contaminated meat, while at the same time doubling the rejection rate of U.S. meat. In addition, a dispute arose between Canada and Puerto Rico over the Canadian export of ultra-high temperature milk, resulting in a 1991 ban of such products and a formal trade challenge under USCFTA.

The draft U.S. position merely states that equivalency agreements "may consider" a trial period. Given the checkered history of some past equivalency agreements, we believe that no agreement should be finalized until after a reasonable trial period has been completed successfully. We, therefore, urge that the word "may" in section 40 be changed to "shall."

IV. Conclusion.

For the foregoing reasons, CSPI respectfully requests that the U.S. delay the advancement of the proposed guidelines. In the event the U.S. decides to proceed, we urge that the guidelines be modified to ensure that countries retain the right to set their own level of protection. In addition, we urge that the guidelines be modified in the specific manner suggested herein.

Respectfully submitted,

Bruce Silverglade
Director of Legal Affairs

Ilene Ringel Heller
Senior Staff Attorney

cc: Fred R. Shank, Director
Center for Food Safety and Applied Nutrition
Food and Drug Administration