Residues of veterinary drugs without ADI/MRL: what Codex and WTO rules apply?

Manfred Lützow^[54], Neuenhof, Switzerland

Definition of the problem

The detection of low levels of residues of certain prohibited veterinary drugs in imported animal products by laboratories in the European Union more than two years ago triggered a discussion within the Codex Alimentarius Commission whether and how the problems causing such events could be addressed.

The question to study is: what supranational rules apply if an importing country detects residues of a veterinary drug of which the presence in a food product is not authorized or the use of the drug is not authorized by its own legislation.

The relevant international framework which needs to be studied in order to answer this question is provided by treaties and agreements of the World Trade Organization (WTO) and the texts adopted by the Codex Alimentarius Commission (CAC).

Sanitary and Phytosanitary Measures (SPS)

The World Trade Organization started to work in 1995, its main objective being the facilitation and promotion of international trade "with a view to raising standards of living, ensuring full employment and a large and steadily growing volume of real income and effective demand, and expanding the production of and trade in goods and services, while allowing for the optimal use of the world's resources in accordance with the objective of sustainable development, seeking both to protect and preserve the environment and to enhance the means for doing so in a manner consistent with their respective needs and concerns at different levels of economic development...".

WTO's main function is to serve as a monitoring forum for the implementation of a number of treaties which were agreed during the so-called Uruguay round (1986-94) and for the settling of trade disputes subject to the rules laid down in those. The more specific principles applied by WTO when developing rules and treaties for trade between her members are:

o Countries may not discriminate trade partners
o National and foreign companies shall be treated equally
o Trade restrictions are justified for the health protection of humans, animals and plants

The control of residues of veterinary drugs in animal products intended for human consumption is a question related to human health which falls as such under the purview of the Agreement of Sanitary and Phytosanitary Measures (SPS). The agreement stipulates that any SPS measure applied by a government to protect should conform with general WTO and more specific SPS rules if it affects products traded between two WTO members. The relevant definition of scope of SPS measure "human and animal life or health [...] from risks from food additives, contaminants, toxins, disease causing organisms in foods, beverages or feedstuffs" includes also measures that address residues of veterinary drugs (SPS Agreement, Annex A, 1.(b)).

Such measures may be laid down in laws, decrees, regulations, requirements or procedures related to the various actions that control or affect the putting into circulation of a product. Among the measures listed by the SPS agreement some of the following may be relevant to the question to be studied: end product criteria, production methods, testing, approval procedures, sampling procedures or risk assessment.

Countries have the right to establish appropriate levels of protection for their own population; however, they need to apply available scientific evidence when establishing sanitary or phytosanitary measures. Such steps may not be discriminatory or unnecessarily restrictive (whether open or in disguised form).

Members shall base SPS measures on international standards, guidelines and recommendations, but higher level of protection may be applied. Acceptance of other member measures as equivalent is encouraged, if final results are the same; with this respect bi- or multilaterally consultation is encouraged. The SPS Agreement explicitly recognizes the Codex Alimentarius and therewith the work of the Codex Alimentarius Commission which means that a country implementing a Codex standards fulfils the obligation resulting from its membership in WTO and with the relevant provisions of the SPS Agreement.

SPS measures are to be based on an assessment of the risks to human, animal and plant life and health using internationally accepted risk assessment techniques. Such a Risk Assessment should take into account the available scientific evidence, relevant processes and production methods, inspection/sampling/testing methods, prevalence of specific diseases or pests, existence of pest/disease free areas, ecological/environmental conditions, and quarantine or other treatment. For animal and plant life or health any risk assessment should take into account economic factors such as cost of control or eradication, potential damage-loss of production/sale, cost effectiveness of alternative approaches.

Any SPS measure needs to adopted and implemented in a transparent and open way which allows sufficient lead time for comments and the application of a notification procedure. This is obviously of importance for developing countries with limited human and technical resources of importance. The proper notification of an SPS measure involves prompt publication, the provision of information on effected products, the objectives and the rational for the measure; members are obliged furthermore to provide copies of such regulations (on request), and they shall allow other members of WTO to comment and take those comments into account. In case of an emergency members may by-pass some of the normal routines, however, they still are obliged to notify WTO members through the SPS Committee Secretariat and shall take into account any comments.

A second WTO text the Agreement on Technical Barriers to Trade (TBT) could also be of relevance. It shall ensure that technical regulations and requirements for products including the procedures used to assess compliance with them do not create unjustifiable barriers to trade with these products. It encourages, like the SPS agreement, the development and use of international standards. The TBT agreement establishes the right of members to ensure the quality of export products, to protect life or health of humans, animals or plants, to protect the environment, and to prevent of deceptive practices. The agreement applies to all industrial and agricultural products in international trade but it does not affect SPS measures.

Codex Alimentarius (CA)

At the beginning of the 1960ties the FAO Conference and the World Health Assembly decided to launch a joint effort in the area of food which should protect the health of the consumers and ensure fair practices in the food trade. This activity was and continues to be called the Joint FAO/WHO Food Standards Programme; further objectives of it are:

o To promote the coordination of all food standards work undertaken by international governmental and non governmental organizations;

o To determine priorities and initiate and guide the preparation of draft standards through and with the aid of appropriate organizations;

o To finalizing standards and, after acceptance by governments, to publish them in a Codex Alimentarius either as regional or world wide standards;

o To amend published standards, after appropriate survey in the light of developments.

The main visible output of this programme is the Codex Alimentarius, a collection of food standards and guidance documents which is published in several volumes by FAO (jointly with WHO). Among these standards are e.g. maximum residual limits for veterinary drugs (MRLVD) and further documents related to the use and control veterinary drugs and their residues (e.g. criteria for the validation of analytical methods).

The Codex Alimentarius Commission (CAC) "shall be responsible for making proposals to, and shall be consulted by, the Directors-General of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) on all matters pertaining to the implementation of the Joint FAO/WHO Food Standards Programme". Any member of FAO or WHO may become member of the CAC and thereby participate in the preparation and adoption of food standards and other documents related to food safety and food quality (currently 170 countries and one organization are registered as members). Non-member countries, international organizations and international non-governmental organizations may attend meetings as observers. The work of the Commission is governed by Statutes, Rules of Procedure and several other documents which are published by FAO together with other important information in a Procedural Manual (13^th edition, Rome 2003).

The Codex Alimentarius Commission is meeting one time a year; its deputy governing body is the Executive Committee. Technical discussions are done by commodity committees (e.g. the Codex Committee on Fish and Fishery Products), horizontal committees (e.g. the Codex Committee on Residues of Veterinary Drugs in Foods/CCRVDF), regional committees (e.g. FAO/WHO Coordinating Committee for Asia) or task forces (e.g. Ad hoc Codex Intergovernmental Task Force on Animal Feeding). Whereas the sessions of CAC and EC meet either at Rome or Geneva, meetings of subsidiary bodies are hosted by governments. The Secretariat of the Commission is the responsible managing unit for the work of the CAC and its bodies; the Secretariat is located at FAO and integrated into FAO's administrative structure.

The elaboration of standards follows a step-wise procedure which involves several times the responsible technical committee, occasionally other interested committees, the Executive Committee and, finally, always the Commission itself that bears the ultimate responsibility for the adoption of any text. The Codex Commission generally adopts standards in consensus.

All Codex food standards and other documents that intend to provide a basis for any regulation along the food chain shall be based on the principle of sound scientific analysis and evidence, involving a thorough review of all relevant information, in order that the standards assure the quality and safety of the food supply. As described above WTO requires for SPS measures the use of internationally accepted risk assessment techniques. In response to this requirement and the increased role the Codex Alimentarius gained being formally recognized by WTO, FAO and WHO hold between 1995 and 1999 a series of consultations which led, inter alia, to a the adoption of Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius and the definition of terms used in such risk analysis processes. Any such risk analysis should be applied consistently, be undertaken openly applying a transparent process, and be documented properly.

Any risk analysis process shall be based on a structured process that involves three linked components: risk assessment, risk management and risk communication. Whereas risk assessment is an activity of dedicated and independent experts who provide scientific advice to Codex, risk management remains on an international level the prerogative of the Codex Alimentarius Commission which includes the determination of risk assessment policies. Such policies shall describe the mandate of risk assessors and ensure that a risk assessment is "systematic, complete, unbiased and transparent". The mentioned document also stipulates that "the needs and situations of developing countries should be specifically identified and taken into account by the responsible bodies in the different stages of the risk analysis."

Codex and residues of veterinary drugs

In 1985 the Codex Alimentarius Commission recognized that "the occurrence and safety of residues of veterinary drugs in foods of animal origin was of significance to public health and consumer concern" and agreed to establish a Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) with the tasks

o to determine priorities for the consideration of residues of veterinary drugs in foods;

o to recommend maximum levels of such substances;

o to develop codes of practice as may be required;

o to consider methods of sampling and analysis for the determination of veterinary drug residues in foods.

The committee is hosted by the US government and met for the first time in 1986. As indicated in its terms of references, its main task is to propose MRLs for veterinary drugs. Proposals of compounds for which MRLs shall be elaborated or proposals for the revision of existing MRL are considered initially by the CCRVDF and submitted to the Commission for approval as new work. Only proposals for which the relevant scientific data are available are supported.

The scientific assessment of the data is undertaken by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) that started to evaluate residues of veterinary drugs in 1987. The Joint Secretariat of JECFA will put requests from the CCRVDF on the agenda of a forthcoming meeting of the expert committee. In case JECFA proposes new MRLs for a drug in a tissues of a target, such MRLs will enter immediately in to the Codex step procedure for further comments and a possible adoption by the Commission. MRLs will only be adopted if a suitable analytical method for control of the MRL is available.

Since 1986 JECFA has assessed residues of around 75 drugs of which approximately 50 have received officially adopted Codex Maximum Residual Levels of Veterinary Drugs (MRLVD). These numbers are far less impressing than the lists resulting from similar work of other authorities (e.g. Australian Pesticides and Veterinary Medicines Authority/APVMA, US Food and Drug Administration/USFDA, Committee on Veterinary Medicinal Products/CVMP). It is not the place to discuss the reasons for this weak performance (the problem is currently under discussion in the CCRVDF), but it should to be noted that the Codex Alimentarius provides only a rudimentary list of residues of veterinary drugs. Despite original intentions a comprehensive positive list was not established which is remarkably in contrast to other groups of food chemicals (i.e. food additives and residues of pesticides) where Codex succeeded in establishing globally recognized listings of acceptable substances.

Other Codex texts

There are some few other texts adopted by the CAC which are of relevance to our question among them

o Codex guidelines for the establishment of a regulatory programme for control of veterinary drug residues in foods (CAC/GL 16-1993 - currently under revision);

o Recommended international code of practice for control of the use of veterinary drugs (CAC/RCP 38-1993);

o Guidelines for the exchange of information between countries on rejections of imported food (CAC/GL 25-1997);

It should be noted that these are guiding documents not "standards", member countries do not have the same obligation to implement them since they do not describe the properties of products that enter into international trade. However, from a WTO point of view there is should not be a difference between standards and guidelines elaborated by Codex.

Analysis of an arbitrary case

For the purpose of an analysis we shall assume that a control laboratory in country X using an improved analytical method detects nitrofuran residues in cured pork meat that is marketed by a local supermarket chain. This drug is prohibited since five years. The responsible national authorities request the removal of the lot from the shelves and their subsequent destruction, and ask for further information about the origin of the pork which is identified to be imported from country Y. After the detection of similar residues in pork sausages, country X decides to issue a ban on all pork meat imports from country Y. This action outrages the producers in the exporting country who claim that they have stopped use already two years go, they ask their government to present their case. What rules apply?

The Codex Alimentarius does not mention residues of nitrofurans in any of its standards or documents, the analytical method country X's laboratory is using has not been considered by any of the Committees, all other Codex texts about sampling and analytical method provide as well little help since they put focus on compliance with existing Codex MRLVDs but do not address the present case, a substance without an MRL. The government detects some interesting paragraphs in a Codex guideline (CAC/GL 25) that demands that country X should provide information on the identity of the contaminant not having an MRL and the sampling and analytical method used for its determination.

The SPS Agreement addresses under Transparency in Article 7 and Annex B cases when international standards do not exist and puts some interesting ideas about the obligations of country X. At an early stage a notice shall be published in such a manner as to enable interested Members to become acquainted with a proposed regulation; such notifications shall even take place at an early stage, when amendments can still be introduced and comments taken into account. It is also noted, however, that in case of an urgent problem of health protection action may be taken without doing so but still notifying members of WTO and providing, on request, copies of the regulations. And, very important: an exporting developing country shall receive from the importing developed country technical assistance if substantial investments would be necessary to maintain and expand market access.

Synthesis and conclusion

The current international framework of Codex Alimentarius and SPS Agreement does not provide specific standards or guidelines for residues of veterinary drugs without ADI/MRL. Problems arising from the presence of such residues in traded food products need to be addressed therefore in bilateral discussions which depend on the more general guidance by Codex and SPS texts for such cases and the good will of the importing developed country and the technical and financial capacity of the exporting developing country. As a consequence, existing bilateral agreements (e.g. the EU import authorisation scheme for animal products) are the main framework that is applicable to such trade problems. This means that the main target markets' regulations for residues of veterinary drugs without ADI/MRL (to be followed by exporting countries) constitute the current de-facto international regulatory framework. Any remaining disagreement that cannot be sorted out in a bilateral discussion could only be addressed further by the dispute settlement procedures of WTO.