January 22, 1999
Catherine E. Woteki, Ph.D.
Under Secretary for Food Safety
U.S. Department of Agriculture
1400 Independence Avenue S.W.
Washington D.C. 20250
Dear Under Secretary Woteki,
We are writing in regard to the U.S. position on the proposed Codex General Standard for Food Additives.1 We support the position taken by the U.S. delegation in opposing the listing of numerous additives in the General Standard that pose safety concerns and are not approved for use in the United States. However, the U.S. should strongly object to the listing of all additives and/or specific uses of additives in the General Standard that are not permitted in the U.S. and that are not universally regarded as safe. Alternatively, the U.S. may simply wish to urge the Codex Alimentarius Commission to redesignate the General Standard as a non-binding advisement.
As you know, Codex standards now carry legal significance within the U.S. The World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS)2 encourages nations to base domestic regulatory standards on international standards developed by the Codex Alimentarius Commission. Domestic regulatory requirements that are based on Codex standards are presumed to be consistent with the SPS Agreement,3 and those that differ from Codex standards may be challenged as trade barriers. Thus, the General Standard on Food Additives, as presently drafted, may invite a challenge to U.S. regulations brought by a foreign country before a dispute resolution panel of the WTO.4
If another nation succeeds in a complaint brought before the WTO, American consumers may be forced to accept imported foods containing unapproved additives. In theory, while the U.S. could ignore the WTO decision, it would have to pay reparations to the complaining country. As a practical matter, it is unlikely that the Administration and the Congress would ignore a WTO decision. In most cases, the U.S. would likely be pressured simply to accept the importation of foods containing unapproved additives.5
Acquiescence to the Codex General Standard would be counter to the Administrations stated policy regarding international harmonization of regulatory standards. In a recent speech to the WTO, President Clinton said:
We must build a trading system for the 21st Century that honors our values as it expands opportunity. We must do more to make sure that this new economy lifts living standards around the world, and that spirited economic competition among nations never becomes a race to the bottom in environmental protections, consumer protections and labor standards. We should level up, not level down [emphasis added].6
The Codex General Standard, however, represents a leveling down, not a leveling up, of controls on food additives and would in fact, if adopted weaken consumer protection. This result is particularly disturbing considering that the FDA was responsible for chairing the working group that helped draft the General Standard. Instead of solely trying to protect the health of American consumers, agency personnel attempted to wear two hats by trying to both facilitate international trade and defend the publics health.
While that strategy served the interests of multinational food companies, it was adverse to the interests of American consumers because the result was the inclusion of numerous additives in the proposed General Standard that are not permitted in the U.S. As the U.S. delegation recognizes, substances such as alitame, curcumin, and diphenyl are included in the Codex General Standard yet are not permitted in the U.S. because of safety concerns.
We further note that:
Similarly, portions of the draft Codex General Standard permit the use of additives used in the U.S. at levels or in specific foods that have not been approved. The FDA has the statutory responsibility to ensure that food additives are safe by prescribing limitations on the levels of use, by restricting the types of foods in which the additive can be used, and by limiting the additives purpose for which it may be used.10 Nonetheless, a number of provisions in the Codex General Standard allow for the use of additives in specific foods and in quantities that are not permitted in the U.S. For example:
- The Codex General Standard allows the use of cyclamates, which have been banned in the U.S. since 1970.7 The FDA banned cyclamates after animal studies linked the artificial sweetener to birth defects, the impairment of the function of testes, and the enhancement of the carcinogenic effect of cancer-causing chemicals.8 Nonetheless, the Codex General Standard would allow the use of cyclamates in carbonated soft drinks and other foods that could result in the consumption of large amounts of a food additive that the FDA has previously found to be unsafe.
- The Codex General Standard permits the use of alitame, another artificial sweetener.9 The FDA has not approved the use of this additive, and the addition of this unapproved substance in a wide range of foodstuffs could raise serious public health concerns.
In light of the new legal effect of Codex standards, the U.S. must oppose portions of the General Standard for Food Additives that pertain to substances that are banned or not approved for specific uses, or at specific levels, in the U.S. unless the FDA has determined that such substances are GRAS. If the U.S. fails to take such action, it would be facilitating a trade challenge before the WTO that could very well lead to the invalidation of FDA regulations intended to protect the health of American consumers.
- In 1986, the agency concluded that the use of sulfites in some instances, because of the incidence of severe allergic reactions, was not Generally Recognized as Safe (GRAS) and changed its regulations to restrict the use of these additives.11 The FDAs regulations also bar the use of sulfites on meats.12 In contrast, the General Standard for Food Additives allows the use of sulfiting agents on fresh meat, poultry and game.13
- In 1970 concerns were raised that nitrate could be converted to nitrite which, when combined with secondary amines, forms cancer-causing nitrosamines. As a result, the U.S. banned nitrates from most processed meats.14 The proposed General Standard for Food Additives, however, allows their use in a far greater number of foods than is permitted in the U.S., including cheese and alcoholic beverages.15
As an alternative to opposing large portions of the General Standard, the U.S. should urge the Codex Alimentarius Commission to re-designate the Standard as a non-binding advisement. Advisements do not carry the force of law under the SPS agreement and would not raise the possibility that domestic regulations would be lowered in response to objections raised by the WTO. By supporting the designation of the General Standard as an advisement, the U.S. could continue to support the goals of international harmonization while protecting the interests of American Consumers.
Director of Legal Affairs
Michael F. Jacobson
1. Codex Alimentarius Commission, Alinorm 99/12, para. 26 and Appendix II, General Standard
for Food Additives (1998). Proposed Draft Schedules of Food Additives (Antioxidants, Preservatives,
Stabilizers, Thickeners and Sweeteners) Specifically Permitted in Foods.
2. Agreement on the Application of Sanitary and Phytosanitary Measures, GATT Doc. MTN/FA
Ii-A1A-4 (Dec. 15, 1993) in Final Act Embodying the Results of the Uruguay Round of Multilateral
Trade Negotiations, GATT Doc. MTN/FA (Dec. 15, 1993) 33 I.L.M. 9 (1994) (hereinafter Uruguay
3. SPS Agreement, Article 3.2.
4. Although the SPS Agreement permits nations to have different standards if they are
scientifically justified, a recent WTO decision has interpreted this provision narrowly. EC Measures
Concerning Meat and Meat Products (Hormones), Complaint by the United States, Final Report,
World Trade Organization, 1997.
5. Even if the Food and Drug Administration, or the Department of Agriculture, were to
undertake notice-and-comment rulemaking to permit the use of the additive in the U.S., such actions
might merely constitute a post hoc rationale for a decision that had already been predetermined by
international trade concerns. As such, any rulemaking conducted by FDA or USDA would not
represent a genuine opportunity for notice and comment as required by the Administrative Procedure
6. President William Jefferson Clinton, Statement to the World Trade Organization, (June 1998).
7. Codex Alimentarius Commission, Alinorm 99/12, Appendix II, General Standard for Food
Additives at 58 (1998).
8. 21 C.F.R. § 189.135.
9. Codex Alimentarius Commission, CX/FAC 99/6, General Standard for Food Additives at 4,
10. 21 U.S.C.A. § 348(c)(1)(A).
11. 51 Fed. Reg. 25,021 (1986).
12. 21 C.F.R. §§ 182.3616, 182.3637, 182.3739, 182.3766, 182.3798, 182.3862.
13. Codex Alimentarius Commission, CX/FAC 99/6, General Standard for Food Additives at
14. 9 C.F.R. §§ 318.7 and 381.147
15. Codex Alimentarius Commission, CX/FAC 99/6, General Standard for Food Additives at 97,