CSPI International
Center for Science in the Public Interest

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

October 6, 1997

Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Drive
Room 1-23
Rockville, Maryland 20857

Re: Docket No. 97N-0218. Consideration of Codex Alimentarius Standards; Advance Notice of Proposed Rulemaking

The Center for Science in the Public Interest (CSPI) submits these comments on the Food and Drug Administration's (FDA) advance notice of proposed rulemaking to amend regulations governing procedures for the review and evaluation of standards adopted by the Codex Alimentarius Commission (Codex). We disagree with the FDA's statement that this proceeding will help the agency "to better meet its public health mission." Codex standards often fall below current FDA regulatory requirements. Furthermore, the impetus for FDA's review of Codex standards is international trade concerns, not public health.

CSPI's comments will focus primarily on five points: l) the FDA has been given conflicting missions as a governmental body obligated by international trade agreements and as an administrative agency bound by the statutory requirements of the Federal Food, Drug and Cosmetic Act (FDCA) and the Administrative Procedure Act (APA); 2) the FDA may only resolve the conflicts by putting statutory considerations first; 3) the FDA's review of Codex standards should be conducted on a case-by-case basis "as requested," rather than as a massive review of all Codex and U.S. standards, so that the FDA can engage in "reasoned decision-making" as required by the APA; 4) the cost of reviewing Codex standards should be paid for by food companies engaged in international commerce; 5) FDA's own resources could be more wisely spent on determining how the agency can support its regulations that exceed Codex standards so that the FDA can be prepared to prevail against any challenges to current regulations brought by other nations under the trade agreements.

I. FDA Has Been Given Conflicting Regulatory Roles; It Must Place Its Statutory Mandate Ahead of International Trade Pressure to Harmonize Health and Safety Standards.

A. The GATT Obligates the FDA to Utilize International Standards.

The Uruguay Round of the General Agreement on Tariffs and Trade (GATT) includes two agreements that have a direct bearing on food safety and labeling: The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT). The thrust of both agreements in the area of food regulation is to encourage nations to support the development of international standards and to adopt such standards as domestic requirements, thus easing the flow of products across borders. The SPS Agreement urges nations to harmonize food safety standards, such as food additive regulations, pasteurization requirements, and inspection procedures. The TBT Agreement urges nations to harmonize technical regulations, including packaging, marking, and labeling requirements, such as nutrition labeling.

The Uruguay Round Agreement Act of 1994 enhances the legal effect of GATT by providing that the Agreement is binding on all World Trade Organization (WTO) members. This provision reflects a shift from past rounds where parties to GATT could selectively choose which agreements to accept.

The Uruguay Round Agreement also establishes a procedure by which a nation may bring a complaint before the WTO and challenge a WTO member's regulation. In such cases, the WTO establishes a Dispute Settlement Body (DSB) to hear challenges and issue rulings determining whether the regulation of a particular nation constitutes an improper restriction on trade. If the DSB finds that a regulation violates the SPS or the TBT Agreements, and hence constitutes an illegal trade barrier, a nation must abide by the decision or face WTO-ordered trade sanctions, such as higher tariffs or other punitive measures.

B. The GATT Penalizes Countries with Stronger Standards Than Those Issued by Codex.

Significantly, the SPS Agreement designated the Codex Alimentarius Commission as one of the sources for recognized international standards for use in resolving trade disputes between nations. Regulatory requirements of a nation that are based on Codex standards are presumed to be consistent with the SPS Agreement. Regulatory requirements that exceed Codex standards may be challenged as trade barriers. As a result, Codex standards now carry legal significance within the U.S. because other countries may challenge any U.S. regulatory standard as a trade barrier if the standard exceeds the requirements set by Codex. Codex, however, was not created as a means of reducing the level of risk to the health of the American citizen. Rather, it was designed to help developing nations achieve some minimal standards of safety.

The TBT Agreement also requires governments to use relevant international standards as a basis for technical regulations. These standards may include those developed by Codex as well as other international bodies. Technical regulations that are in accordance with international standards are presumed to be in compliance with the TBT Agreement. A technical regulation that is not in accordance with international standards may be found to violate the TBT Agreement if another measure is reasonably available to the government that fulfills the government's legitimate objectives and is significantly less trade-restrictive. What is particularly troubling is that under the SPS and TBT Agreements, Codex requirements are seen as a ceiling -- a maximum limit on the regulatory restrictions that may be imposed before a trade barrier is presumed to exist -- while U.S. food and drug law has always been interpreted expansively.

As a result of objections by consumer and environmental protection organizations made toward the end of negotiations on the Uruguay Round Agreement, a number of provisos were added to the SPS Agreement before it was finalized. For example, the SPS Agreement purportedly reaffirms the right of countries to take unilateral measures to protect human, animal, and plant life and health. In this regard, health-related regulations that exceed Codex standards may be permitted if there is a "scientific justification" or as a "consequence of the level of protection a Member determines to be appropriate." Similarly, in the TBT Agreement, if international standards are an "ineffective or inappropriate means" to fulfill the government's legitimate objectives, a nation need not use them.

However, the SPS Agreement also states that in determining the appropriate level of sanitary or phytosanitary protection, other factors should be taken into account including the overall objective of harmonizing trade effects, the special needs of developing countries, and any risks to which consumers voluntarily expose themselves. Moreover, it is a general tenet of statutory construction that ambiguous provisions of a law are to be construed in accordance with the law's overall purpose. The overriding purpose of the SPS and TBT Agreements is to facilitate trade by harmonizing regulatory requirements on an international basis. Given the overarching purpose of the agreements, the U.S. government can provide no real assurances to American consumers that FDA regulations will not be adversely affected.

On August 18, 1997, the WTO issued a final report in response to a complaint by the U.S. regarding the European Union's (EU) ban on imports of beef treated with growth hormones. The report stated that the complaining party bears the burden of proof in presenting a prima facie case of inconsistency with the SPS Agreement. Thus, the complaining party must simply present an argument that demonstrates a violation of the SPS Agreement, i.e., that there is an international standard with respect to the measure in dispute and that the measure in dispute is not based on this standard.

The burden then shifts to the responding party to demonstrate that the measures in dispute meet the requirements imposed by the SPS Agreement, i.e., that the measures are based on a risk assessment in accordance with Article 5 of the Agreement. In order for the measure to be considered as based on a risk assessment, the responding party must provide evidence that it actually took a risk assessment into account when it enacted or maintained its sanitary measure. The report concluded that the EU did not satisfy this burden and that the EU measures were, therefore, inconsistent with its obligations under the SPS agreement.

This decision may mean that the margins of safety built into U.S. law -- e.g., the Delaney Clause and regulatory requirements designed to protect even the most "ignorant, unthinking and the credulous" consumers against misbranding abuses -- may be susceptible to challenge under the GATT code. Thus, we disagree with the FDA's statement that this proceeding will help the agency "to enhance consumer protection with regard to foods [and] to better meet its public health mission."

C. Codex Standards Are Often Weaker Than Current FDA Requirements.

We further object to FDA's statement that this proceeding will help enhance its public health mission because Codex standards are often weaker than FDA rules.

  • The Codex natural mineral water standard does not meet FDA hygiene or quality regulations for bottled water. In 1995, following years of protest by consumer organizations, FDA adopted regulations for bottled water, establishing a standard of identity and bringing mineral water under existing quality standards for bottled water. The regulations also require that mineral water contain a minimum amount of minerals and that consumers be informed if the mineral content is high or low. The Codex standard permits the bottling of mineral water at its source without antimicrobial treatment.

  • Codex Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems may be construed as requiring nations to consider food inspection systems that rely on internal program evaluations conducted by non-governmental authorities as equivalent to inspection systems operated by government agencies.

  • The Codex General Standard on Food Additives also contains a large number of substances not approved by FDA for use in the U.S. The FDCA specifically provides that "a food shall be deemed to be adulterated -- . . . if it is, or bears or contains, any food additive which is unsafe within the meaning of section 409." That section specifies that an additive will be deemed unsafe for purposes of the adulteration provisions of the Act unless the additive is used in accordance with a food additive regulation prescribing conditions of safe use. Exemptions from this clause are only provided for additives under investigational use that comply with a regulatory exemption.

  • The Codex General Standard for Food Additives listsby the U.S. in 1987 because of the overwhelming evidence that such foods were the cause of serious disease outbreaks.

    D. The Trade Agreements Do Not Supersede the FDCA or Its Implementing Regulations.

    In passing enabling legislation for the trade agreements, Congress precluded the FDA from modifying its regulations to comply with Codex standards unless it follows the requirements set forth under the APA. To the extent a modification requires changes in the 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 which 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 law, 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 regulation is required, follow normal agency procedures for amending regulations.

    Thus, although the SPS and TBT Agreements place pressure on the FDA to harmonize U.S. standards with those adopted by Codex, 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 as required by the APA. The fact that Codex standards have been developed without the procedural requirements for public accountability required by the APA presents a compelling argument for why such standards cannot be thrust upon the American people without appropriate notice and comment safeguards.

    The FDA, therefore, is in the unenviable position of being caught between the proverbial rock and a hard place. What is clear is that FDA cannot compromise the health and safety of consumers to facilitate international trade. What is equally clear is that if FDA is to uphold standards that are more restrictive than those adopted by Codex, it must be sure that it has adequate documentation, including risk assessments, to back up its rules. As the WTO beef hormones case illustrates, when an international dispute settlement body evaluates whether a country's desire to protect its citizens from perceived risks has a legitimate scientific basis, a country must be able to muster a strong scientific arsenal to protect the viability of its regulations.

    Thus, the FDA's limited resources would be better spent building up support for its current regulations that are susceptible to being challenged as trade barriers rather than reviewing Codex standards.

    If the FDA proceeds with this review, however, it must determine the instances in which conflicts exist between U.S. and Codex regulations. If conflicts exist, the FDA must evaluate whether the statute, the regulation, or both are directly involved. To the extent modifying a regulation would violate the FDCA, the FDA is precluded from acting without Congressional authorization. To the extent the FDA may act to modify a regulation without violating the FDCA, the FDA must go through the full notice and comment rulemaking in accordance with the standards set forth by the APA. The importance of keeping these parameters in mind is underscored by the fact that, in general, Codex standards are weaker than U.S. standards.

    II. FDA Should Adopt A System of Presumptions to Expedite the Review of Codex Rules.

    It is evident that automatic adoption of Codex regulations may not occur because to the extent there are any differences between Codex and existing U.S. standards, careful evaluations must be made to ensure that the adoption of the Codex standard would not violate the FDCA. But careful consideration of each Codex regulation takes time and will stretch FDA's limited resources.

    To facilitate international trade without weakening U.S. standards, we urge the following approach:

    • FDA should automatically reject Codex standards that fall below U.S. standards.

    • FDA should consider adopting Codex standards that provide a greater level of protection than current U.S. standards or address concerns not yet regulated under U.S. law. An example of how Codex standards could be used to fill gaps in U.S. regulations is illustrated by Codex's development of standards for energy claims. CSPI filed a petition with FDA on November 26, 1997, requesting the agency to prohibit the unapproved use of the term "energy" on product labels. No action has been taken on the petition. Codex, however, is in the process of developing standards for sports drinks and energy drinks. The FDA may wish to consider such standards for adoption.

    • If FDA is considering a new rulemaking proceeding on a substance, it should request public comment on relevant Codex standards.

    • No distinction should be drawn between pre-1993 Codex standards and post-1993 standards. The FDA incorrectly assumes that post-1993 standards are "better" standards than the pre-1993 ones because post-1993 standards were intended to become international standards, while pre-1993 standards were intended only to provide guidance to developing nations. But as set forth above, even some of the latest standards adopted by Codex are weaker than U.S. standards.

    • Any review of Codex standards should, of course, be science-based. But the review must also address consumer protection, including all issues that might render a product misbranded.

    III. Review of Specific Codex Standards Should Take Place Only Upon Receipt of a Petition.

    We believe that a review of Codex standards should take place only after a petitioner makes a request and establishes that the action requested would not lower current FDA standards or otherwise raise public health concerns. The FDA should be aware that companies who request such a review may care little about the welfare of American consumers. Because the U.S. market may comprise only a small part of a company's sales -- even for American companies -- manufacturers may be motivated by global economics rather than the safe use of the product in the U.S. For example, sales figures for the American-based Coca-Cola Company indicate that total world sales (excluding U.S. sales) for 1997 were almost double the domestic sales volume.

    Moreover, requiring public comment on multitudes of Codex standards at once is totally unworkable and undermines "reasoned-decision-making" as required by the APA. As the Tenth Circuit explained in interpreting its duty to determine whether an agency rule is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," as set forth in the APA:

    All the agency need do is demonstrate it considered relevant factors and alternatives after a full ventilation of the issues, and that the choice it made was reasonable based on those considerations.

    If the FDA were to issue a notice seeking public comment on a wide array of Codex standards for simultaneous review, it is doubtful that the agency could expect to achieve the "full ventilation of issues" required for reasoned decision-making. The public would be hard pressed within the span of a 60, 90, or even a 120-day comment period to digest and reflect upon the complex issues raised in a regulatory action of such magnitude.

    Significantly, when the Occupational Safety and Health Administration (OSHA) attempted to adopt permissible exposure limits for 428 air contaminants in a single rulemaking proceeding, an appellate court overturned the regulations. As in the case of the FDA and Codex, the OSHA regulations, initially at least, had been based on consensus standards, and OSHA had limited the rulemaking to standards recommended by a consensus group that were either new or more protective than existing exposure limits. OSHA feared that if it followed its previous substance-by-substance approach to rulemaking, it would be decades before it could establish exposure limits for the seemingly endless list of substances requiring regulation. Although the court was sympathetic to the vast number of contaminants needing regulation, it nevertheless struck down the regulations as violative of the Occupational Safety and Health Act. In issuing its decision, the court focused on "such relevant evidence as a reasonable mind might accept as adequate to support a conclusion."

    Based on its review of the record, the court concluded that OSHA had issued 428 "inadequately supported" standards. The court said that "OSHA has lumped together substances and affected industries and provided such inadequate explanation that it is virtually impossible for a reviewing court to determine if sufficient evidence supports the agency's conclusions."

    Any attempt by the FDA to issue an umbrella regulation adopting Codex standards en masse would meet a similar fate.

    IV. Food Companies Engaged in International Trade Must Subsidize the Cost of Codex Review through Licensing Fees.

    To pay for the cost of reviewing Codex standards, an import/export fee should be imposed on all U.S. companies that export products and on foreign companies that market products in the U.S. The fee could be adjusted on a sliding scale based on gross international sales. Small businesses could be exempted from the requirement. The fee should not be tied to FDA review of a specific standard in order to protect the objectivity of the review process. The FDA should not proceed with a review of Codex standards until the Administration seeks and obtains authorizing legislation.

    V. Conclusion

    Contrary to the FDA's assertion, this proceeding does not enhance the agency's public health mission. For the foregoing reasons, CSPI therefore recommends that the FDA stay this proceeding and spend its limited resources more wisely by determining how it can best bolster support for current regulations that exceed Codex standards so that the agency can be prepared to win any challenges to its rules brought under the trade agreements.

    Codex standards should only be reviewed when requested, and such reviews should not be commenced until Congress provides the agency with the authority to assess fees to pay for such activities. Any broad based review of Codex standards would violate the reasoned decision making requirements of the APA and be invalidated by the courts.

    Respectfully submitted,

    Bruce Silverglade
    Director of Legal Affairs

    Ilene Ringel Heller
    Senior Staff Attorney