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Comments in Response to
The Food and Drug Administration's Request of July 7, 1997
Action: Advance Notice of Proposed Rulemaking
Proposed Rules on Consideration of Codex Alimentarius Standards
Federal Register: July 7, 1997 (Vol. 62, #129) pp.36243-36248
Docket No. 97N-0218 RIN 0910-ZA01

Prepared by

The Law Loft

on behalf of The Life Extension Foundation and the National Health Federation

The Law Loft on behalf of the National Health Federation, a non-profit, consumer organization, and on behalf of the Life Extension Foundation, a non-profit consumer membership organization, submits the following comments in response to the United States Food and Drug Administration's request for written comments in re: Advance Notice of Proposed Rulemaking in re: establishment of new administrative procedures for review and evaluation of standards adopted by the Codex Alimentarius Commission.

The statutory missions of the Codex Alimentarius Commission and the United States Food and Drug Administration are neither congruent nor compatible:

From the very outset of its description of the Codex Alimentarius Commission, its purpose and objectives, the Food and Drug Administration seeks to gloss over the serious differences in mission and purpose that distinguishes it from the international commission known as the Codex Alimentarius Commission.

The Codex Alimentarius Commission is a combination trade, business, and international standard setting organization

The Codex Alimentarius Commission which in its present form exists under the joint auspices of the Food and Agriculture Organization of the United Nations (WHO) as part of the Joint FAO/WHO Food Standards Programme, is an organization with a mission that is very different from that of the FDA.

Article One of the Statutes of the Codex Alimentarius Commission states that the mandate or mission of the Codex Alimentarius Commission is:

(A) protecting the health of consumers and ensuring fair practices in the food trade;

(B) promoting coordination of all food standards work undertaken by international governmental and non governmental bodies;

(Emphasis added)

Thus from the outset it has been clear that the Codex Alimentarius Commission considers as its co-equal missions: protection of the health of consumers and promoting fair practices in food trade and that the Codex Alimentarius Commission recognizes no inherent meaningful distinction between international governmental organizations and international trade or industry based or sponsored organizations which may have as their agenda the promotion of the best interests of a particular trade or industry at the international level.

In addition, the Codex Alimenarius Commission as an international body makes little or no provision for the minimum requirements of representative governance. For example, Codex Committee Chairmanships can and have remained vested in the hands of a particular nation state for decades at a time, with no mechanism for either rotation of chairmanships or accountability for the acts of particular nations as the chair of a particular committee. Many nations have retained chairmanships in an uninterrupted fashion for the last thirty or more years.

Committee chair nations wield considerable power under the Codex system since a chair nation is responsible not only for the costs associated with the assumption of that role but also for the shepherding of committee recommendations throughout the Codex process. The Codex process contains no meaningful system of accountability for acts of chair nations or mechanism for containment or review of the considerable powers wielded by chair nations.

Similarly, under the Codex system no meaningful consumer representation is present. At present, a single so called consumer organization, the International Association of Consumer Unions has official organizational status at the Codex Alimentarius Commission. IOCU lacks the power to vote within the Codex system, speaks only when called upon and essentially observes a process in which it plays little or no meaningful role.

Within the Codex system in which a one nation, one vote rule is applied, nations are often represented by unelected bureaucrats unacquainted with the demands of representative government who perform a quasi-diplomatic, quasi-legislative function along with like bureaucrats from other nations. There is no system of accountability within Codex or here at home within the United States that systematically reviews or calls to public account the functioning of these unelected representatives at the international level.

Within the United States delegation, the voting delegate is assisted by a group of non-voting delegates who are selected by either the Department of Agriculture and or the Food and Drug Administration under and ill defined and unregulated system in which the agencies openly represent vested commercial interests or commercial interests thinly disguised as consumer groups with no requirement that genuine consumer or public interests be represented at all.

(Recently the US delegate raised his voice against the notion that this system needed to be corrected in order to provide even a modicum of public representation.)

Making matters even worse, the Codex Alimentarious Commission is in certain key areas not the master of is own deliberations. For example, key scientific evaluation and judgmental functions are shunted off to the opaque, closed to the public scrutiny scientific committees that are appointed not by Codex but by the World Health Organization and or the Food and Agriculture Organization.

In the recent past with the radification of both the Uruguay Round of the General Agreement on Tariffs and Trade, the role of the Codex Alimenarius Commission as both an international reference setting body and as a body whose primary mandate is to promote international food trade oftentimes at the expense of consumer safety has been enhanced.

Taking the General Agreement on Tariffs and Trade as our primary example, we see that:

1) Codex role has changed from an essentially advisory body to that of an international food safety standards setting body.

2) Under the new arrangements ratified as part of the GATT, nations set food safety standards higher than those set by Codex at their peril;

3) National Food Safety Standards that are higher than those set by Codex can be challenged in a new international tribunal where that nation's science is measured against Codex science, where trade impact of safety regulalations are considered as potential challenges to safety regulations, and where in order to be found not to be a disguised trade barrier, a nation's higher standard must be based on good risk assessment and risk management decisions and constitute a consistent risk management decision when compared to other like risk management decisions made by that nation-state;

4) By contrast, mere acceptance of a Codex standard by a nation state is presumed not to erect an unfair trade barrier in violation of international obligations;

5) Enforcement and review mechanisms also exist within the World Trade Organization, the international enforcement body that are not only adjudicative as described above but administrative as well. The Committee on Sanitary and Phytosanitary Measures now has the power to command filing of new laws and regulations for its review and the task of harmonizing laws and regulations to international standards.. In other words, the Committee on Sanitary and Phytosanitary Measures has the duty to promote the systematic replacement of national laws and regulations with internationally achieved standards, achieved under the non representative, not accountable conditions described above; and

6)Codex standards which do not deal with food safety per se now default to TBT, Technical Barriers to Trade status. Although less enforceable than standards falling under the SPS, TBT standards retain some level of international enforceability as well.

By contrast, the Food and Drug Administration was designed to be a consumer safety and protection agency accountable to the populace not only through changes in administration but through the administrative procedures process as well:

The United States Food and Drug Administration has an entirely different history and mission than the Codex Alimenarius Commission. By contrast the Food and Drug Administration was created as an exercise of federal government power under the commerce clause of the United States Constitution for the purpose of protecting the public against unsafe products moving in interstate and international commerce. Although the FDA has always been mindful to some degree of the desirability of not erecting unreasonable or unworkable barriers to commerce, its primary mission has always been to protect the public from unsafe or fraudulent products.

Also, in contrast to the Codex Alimenarius Commission, the FDA has existed within a matrix of relationships to the Congress which legislates the laws, the parameters within which it can act, the administrative procedures for creation and review of some regulations within which the public and industrial sectors have rights and remedies and in relationship to a court system which provides a review mechanism calculated to provide review to assure consistency with Congressional and Constitutional requirements.

Unless and until Congress adopts a new mission statement for the FDA (which it is presently considering in the form of legislation now pending in Congress) there is an inherent conflict of interest between the mission of the Codex Alimentarius Commission to promote international trade.

Even if the Congress changes the mission of the FDA to harmonize it with the mission of the Codex Alimentarius Commission, there will remain serious conflicts between the system within which the Food and Drug Administration acts and its checks and balances and concerns for due process of law and the free wheeling non-accountable, non representative international system under which the Codex Alimentarius operates. One wonders here whether or not the Codex system could withstand judicial scrutiny if it were examined for essential compatibility with the requirements of representative government. For example, is the transfer of regulatory standards setting functions off-shore to unelected non-American delegates really consistent with the Appointments Clause of the United States Constitution? Is the transfer of regulatory standards setting functions off-shore to unelected non-American delegates over whom Congress has no control really consistent with the requirements Article I, clause 8, of the Constitution setting forth Congress's duties as to commerce?

By sleight of hand The FDA is attempting to give the Codex Alimentarius Commission even more power over the health and welfare of the American people than even the most expansive reading of our current agreements would warrant:

By a sleight of hand, the FDA in its advance notice of proposed rulemaking is attempting to give the Codex Alimentarius Commission even more power over the American consumer than even the most expansive reading of current international agreements would warrant.

Nowhere in its advanced notice of proposed rulemaking does the FDA in a straight forward fashion address the differences inherent in the determination whether a Codex standard, guideline or regulation falls under the Sanitary Phytosanitary Measures Agreement (SPS) or the Technical Barriers to Trade TBT)agreement of the GATT . Yet there are very substantial differences between the two.

The Sanitary Phytosanitary Agreement acts as an exception to the general parameters of the Technical Barriers to Trade (TBT) agreement. If a Codex standard, guideline or regulation falls under the SPS certain very specific and highly detailed rules of interpretation with few exceptions or escape clauses apply. In its essence, the SPS makes Codex standards, guidelines and recommendations the international reference standards for food safety.

International food safety standards are defined in Annex A as:

" for food safety the standards, guidelines and recommendations established by the Codex Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice."

Sanitary measures are defined in Annex A as:

"-to protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease causing organisms in foods, beverages or feedstuffs."

Thus even if we assume that the Food and Drug Administration is now required by an international agreement achieved in conformity with Constitutional requirements and binding due to the supremacy of treaty law to conform American food and drug law to international requirements as set forth in the Sanitary Phytosanitary Agreement which incorporates by reference Codex Alimentarius achieved standards, guidelines and recommendations, the scope of the Codex standards, guidelines and recommendations that the FDA proposes to adopt through a new rulemaking procedure exceeds the scope of Codex standards, guidelines and recommendations that the FDA is semi mandated to adopt through this agreement.

A single example of how the FDA proposes to adopt Codex standards, guidelines and recommendations beyond the scope of those mandated by the existing international agreements can be found by reference to page two of the notice of proposed rule making in which the FDA states that it proposes to adopt "labeling" requirement(s) and at page three where it describes Codex standards, guidelines and recommendations as including... symbols, packaging, marking, or labeling requirements as they apply to a product, process or production method.

Such issues all fall outside the scope of food additives, veterinary drug and pesticide contaminants, methods of analysis and sampling and codes and guidelines of hygienic practice which are the only proper areas of activity for the Codex as the maker of international reference standards as defined by the Sanitary Phytosanitary Agreement.

The FDA's attempt to expand the scope of adaptation of Codex standards, guidelines and recommendations is neither saved nor mandated by conformity with the Technical Barriers to Trade Agreement. Although the TBT mandates transparency meaning full accessibility of the rule making process to foreign interests and consideration of international standards, it does not bind nations like the USA to the adoption or consideration of international standards to the same degree as the Sanitary Phytosanitary Agreement. Indeed, the preamble to the Technical Barriers to Trade Agreement, expressly states that:

"Recognizing that no country should be prevented from taking measures... for the protection of human animal or plant life and health, ... or for the prevention of deceptive practices, at the levels it consider appropriate...."

Further, under the TBT protection of human health and safety and consumer protection against deceptive practices are expressly recognized as exceptions to the general agreement that international standards be a basis for domestic regulations:

"2.2 Members shall ensure that technical regulations are not prepared adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose technical regulations shall not be more trade restrictive than necessary to fulfill a legitimate objective, taking account of the risks that non-fulfillment would create. Such legitimate objectives are, inter alia.... the prevention of deceptive practices; protection of human health or safety,....."

Article 2: Preparation, Adoption and Application of Technical Regulations by Central Government Bodies

Thus under the TBT considerably more latitude in the acceptance or rejection of international standards is left to the nation state in those areas of health and safety not covered by the SPS as described above. While the TBT encourages the consideration of trade issues in the creation of technical requirements under the TBT and the consideration of international standards with a view toward international harmonization of standards, under the present state of international law in this area, the wholesale adoption of Codex standards in non SPS areas in neither warranted nor legally appropriate.

What Should the FDA do under these circumstances?

Instead of attempting to slip Codex standards through a quasi-legal covering system, the FDA should squarely face the contradictions and ambiguities inherent in the present situation. It could, for example, file an action for declaratory relief in the appropriate federal district court pointing out the discrepancies between its mission and that of the Codex and the non-representative and non-accountable nature of the Codex process and ask the court for guidance as to how if at all it should attempt to adopt newly emerging international standards, and for clarification as to the scope of those standards that it is required to consider for adoption under the present international arrangements.

Instead of pretending that the Codex Alimentarius Commission process is a purely scientific process that the FDA is required to consider in the promulgation of domestic standards, it should look for methods to include public accountability and public representation in its participation in the Codex process, instead of creating merely a shallow pretense of public review after the fact.

And at the very minimum, the FDA should limit its adoption of Codex standards, guidelines and recommendations to those areas that are within the scope of proper Codex activity as defined by the Sanitary Phytosanitary Agreement.

As to Codex standards, guidelines, and recommendations that fall outside of the scope of the TBT, the FDA should concentrate on making its regulatory process transparent to foreign interests without allowing those interests to override its sole existent mission of protection of the public health and safety in international and interstate commerce.

Unless and until Congress turns the FDA into a kind of international Fuller brush man with a trade enhancing mandate, the FDA should for once in its less than illustrious career concentrate on establishing a rulemaking process that respects the notions of public health and safety and representative government with an appropriate regard for the checks and balances and due process of law.

Dated October 6, 1997
Suzanne Harris
for the Law Loft on behalf of
National Health Federation and
The Life Extension Foundation