The Codex Alimentarius Commission was named as the international reference organization for health and safety measures relating to food in the Uruguay Round Text on Sanitary and Phytosanitary (SPS) Measures. This text was brought into force with the establishment of the World Trade Organization (WTO) on January 1, 1995. The WTO is the multilateral organization that will implement international trade rules and is the successor organization to the General Agreement on Tariffs and Trade (GATT).

The primary objective of the WTO is to liberalize world trade and place it on a secure basis, thus contributing to economic growth and development. The WTO also functions as the principal international body concerned with multilaterally negotiating the reduction of trade barriers and other measures that distort competition. Additionally, it serves as a place for countries to raise their concerns regarding the trade policies of their trading partners.

Prior to the WTO agreement, there were no effective international rules to distinguish trade-protectionist measures from legitimate import regulations to ensure food safety or to otherwise protect the health of people, animals, and plants. Under the SPS text, each nation can continue to make a sovereign determination of its acceptable level of risk. Alternatively, countries may use international standards. A nation utilizing an international standard such as a Codex maximum residue limit for veterinary drug residues is seen as meeting its obligations under the provisions of the SPS agreement.

The SPS agreement does recognize the right of countries to maintain standards which are stricter than international standards. However, stricter measures must be based on science and be justifiable as a consequence of a non-discriminatory lower level of acceptable risk. The SPS agreement is designed to curtail current import restrictions that are based on arbitrary and unsubstantiated health and safety concerns. It is also intended to prevent countries from avoiding commitments under the WTO agreement to open their markets.

Because of the awareness within Codex that issues related to veterinary drug residues were creating restrictions to trade in meat and meat products, a separate Codex Committee was formed in 1986 to develop standards to address this problem. The Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF) has been meeting on a regular basis since its formation and has contributed greatly to the Codex process, both through its development of drug residue standards and its illumination of the need to clarify that Codex decisionmaking must be based on science.

Veterinary drug residue standards are proposed to the CCRVDF by the FAO/WHO Joint Expert Committee on Food Additives (JECFA). The JECFA recommends an acceptable daily intake (ADI) and a maximum residue limit (MRL) for a veterinary drug residue in a specific food commodity. An MRL is essentially equivalent to a "tolerance," which is the term used in the U.S. The CCRVDF can either accept, reject, or modify the recommendations of the JECFA and makes a decision whether to forward the draft standard through the Codex Step procedure. The CCRVDF first considers the draft standard at Step 4. If the Committee decides to advance the draft standard, it will be forwarded to the Codex Alimentarius Commission for adoption at Step 5. If the Commission reacts positively to the draft standard, it is then returned to the CCRVDF for consideration as a final draft at Step 7. Final adoption takes place by the Commission at Step 8 when the draft standard is forwarded from the Committee in final form.

This process is very time-consuming. Although the CCRVDF has been meeting regularly since 1986, the first standards for veterinary drug residues in food were not adopted by the Commission until 1993. This delay stems from the controversial nature of the first standards developed by the CCRVDF, those for the growth-promoting hormones. In fact, although these standards were first presented to the Commission for adoption at Step 8 in 1991, final adoption did not occur until the Commission meeting in July 1995.

Standards for the following compounds were adopted at Step 8 (final stage) at the 20th and 21st Sessions of the Codex Alimentarius Commission:

Albendazole
Benzylpenicillin
Carbadox
Closantel
Estradiol 17-B
Flubendazole
Isometamidium
Ivermectin
Oxytetracycline
Progesterone
Sulfadimidine
Testosterone
Thiabendazole
Trenbolone Acetate
Zeranol

In the National Performance Review on Reinventing Food Regulations released in January 1996, FDA and FSIS committed to develop proposed procedures within one year on the review of Codex standards for consideration for acceptance. Currently, FDA only has procedures in place for review of Codex food commodity standards. FDA decisions to accept Codex standards will include the opportunity for public review and comments, especially if a need is identified to revise or revoke existing U.S. requirements. Finalized procedures would allow CVM to make decisions on the acceptance of Codex veterinary drug residue standards, for the purposes of imported food commodities and/or domestic food production.

The National Performance Report also highlighted the need to develop a procedure to allow acceptance of Codex standards when no approval for the drug exists in the U.S. The acceptance of this type of Codex standard would only apply to imported food commodities. Use of the drug in the U.S. would still require the filing and approval of a new animal drug application. FDA is supportive of legislative change to address this problem.

Finally, the U.S. believes that the scientific basis of Codex standards must be enhanced. This issue was outlined in the U.S. Codex Strategic Plan and continues to be a focus of U.S. efforts in Codex. The U.S. is not suggesting that Codex has not utilized good science in the past; however, we believe that certain changes are needed to make the scientific basis of the standards clear, consistent, and transparent. Examples of these changes would be to encourage FAO/WHO to establish minimum data sets for JECFA/JMPR, to establish criteria for selecting experts for expert groups and to make vacancies publicly available, and to assure clear and adequate documentation of the basis for decisionmaking on each standard. The U.S. believes that these changes are necessary to pave the way for greater acceptance of Codex standards in the U.S.

These ongoing harmonization efforts, undoubtedly, will impact on the trade of meat and meat products in the future. The adoption of Codex MRLs for veterinary drug residues by member countries of the Codex Alimentarius Commission will benefit animal producers in exporting worldwide.