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Animals > Animal Diseases > Bovine Spongiform Encephalopathy

Implementing the Standards of the OIE

The Office International des Epizooties (OIE), the World Organization for Animal Health, has issued the following statement cautioning countries not to implement unwarranted trade restrictions against trading partners that have detected bovine spongiform encephalopathy (BSE).

Canadian officials have repeatedly pressed trading partners to base their trade measures on science, consistent with the internationally accepted standards of the OIE. In response, the United States and other countries have partially reopened their borders, yet many trading partners continue to impose trade restrictions contrary to OIE recommendations.

World Trade Organization
	G/SPS/GEN/437 28 October 2003 (03-5707)

Committee on Sanitary and Phytosanitary Measures

Implementing the standards of the OIE - Communication from the OIE

Foreword

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The OIE has become concerned about increased reports of international trade disruptions involving the misinterpretation of OIE standards.

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This paper addresses some apparent misunderstandings about the nature and purpose of the OIE international standards, and their interpretation and implementation. It also discusses how the standards should be referred in Member Countries' notifications.

Introduction

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The OIE (the World Organisation for Animal Health referred to in the Agreement on the Application of Sanitary and Phytosanitary Measures [SPS Agreement] of the World Trade Organization [WTO] as the International Office of Epizootics) is an intergovernmental organization created in 1924 by 28 Member Countries (MC) and with a current membership of 164.

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Its missions are:

Transparency of animal disease status world-wide;

Collection, analysis and dissemination of veterinary scientific information;

Strengthening of international coordination and cooperation in the control of animal diseases;

Promotion of safety of world trade by developing sanitary standards for international trade in animals and animal products;

Improvement of the legal framework and resources of Veterinary Services; and

New mandates for animal welfare and animal production of food safety.

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The OIE is one of the three international standard-setting bodies recognised under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). For animal health and zoonoses, Annex A, paragraph 3 of the SPS Agreement refers to the standards, guidelines and recommendations developed under the auspices of the OIE " … for animal health and zoonoses, the standards, guidelines and recommendations developed under the auspices of the International Office of Epizootics … ".

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The OIE standards comprise two Codes and two Manuals:

Terrestrial Animal Health Code;

Aquatic Animal Health Code;

Manual of Diagnostic Tests and Vaccines for Terrestrial Animals; and

Manual of Diagnostic Tests for Aquatic Animals.

These are the international standards to which Member Countries should refer in setting sanitary measures for international trade of animals and their products. A good knowledge of these standards is essential for the correct notification of sanitary measures within the SPS Agreement.

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The OIE Terrestrial Animal Health Code and the Aquatic Animal Health Code contain standards, guidelines and recommendations designed to prevent the introduction of infectious agents pathogenic to animals and humans into the importing country during trade in animals, animal genetic material and animal products (meat, milk, hides and skins, honey, etc.). The OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals and the Manual of Diagnostic Tests for Aquatic Animals, companion volumes to their respective Codes, provide a uniform approach to the diagnosis of OIE-listed diseases and other diseases of importance to international trade, so that the requirements for health certification in connection with trade in animals and animal products can be met.

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The mission of the OIE regarding the promotion of transparency in the international animal disease situation is addressed in the Terrestrial Code:

"Countries shall make available to other countries, through the OIE, whatever information is necessary to minimise the spread of important animal diseases and to assist in achieving better worldwide control of these diseases; and

"… countries shall also provide information on the measures taken to prevent the spread of diseases; including quarantine measures and restrictions on the movement of animals, animal products and biological products and other miscellaneous objects which could by their nature be responsible for transmission of disease. In the case of diseases transmitted by vectors, the measures taken against such vectors shall also be specified."

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The remainder of this paper addresses only the Terrestrial Animal Health Code (the Terrestrial Code) but the principles apply to all OIE international standards.

Development of OIE standards

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The development of the standards, guidelines and recommendations in the Terrestrial Code is the result of continuous work since 1960 by one of the OIE's Specialist Commissions, the OIE Terrestrial Animal Health Standards Commission. This Commission draws upon the expertise of internationally renowned specialists to prepare draft texts for new articles of the Terrestrial Code or to propose revisions of existing articles in the light of advances in veterinary science. These experts may be drawn from OIE Collaborating Centres and Reference Laboratories (which together constitute a global network of over 150 facilities worldwide). OIE Collaborating Centres are centres of expertise in a designated field (usually a generic subject such as risk analysis methodology or the organisation of veterinary services) while OIE Reference Laboratories are designated to harmonise existing diagnostic procedures and to develop new diagnostic methodologies as well as vaccines relating to the diagnosis and control of diseases listed by the OIE.

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The health measures in the Terrestrial Code (in the form of standards, guidelines and recommendations) are debated by the Members and formally adopted each year by consensus at the meeting of the OIE International Committee (the assembly of the representatives of the 164 Member Countries).

Content of OIE standards

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The Terrestrial Code details health measures to be used by the veterinary authorities (or, in some cases, other competent authorities) of importing and exporting countries to avoid the transfer of agents pathogenic for animals or humans, while avoiding unjustified sanitary barriers. If there is no text for a particular commodity, it means that the OIE has not yet been able to develop a recommendation, and measures for that commodity should be based on a science-based risk analysis.

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It achieves these recommendations through describing detailed measures recommended for commonly traded commodities (e.g. live horses, bovine embryos, fresh meat). All measures are risk-based and reflect the animal health status of the exporting country and the likelihood of the commodity being a source of infection. For reasons of practicability, the recommendations in the Terrestrial Code make reference only to the animal health situation in the exporting country, and assume that either the disease or the strain of the disease is not present in the importing country or is the subject of a control or eradication programme. Almost 100 animal diseases are addressed in the Terrestrial Code. The Terrestrial Code also draws attention to the obligations under the provisions of the SPS Agreement, whereby the importing country cannot be more trade restrictive than necessary to achieve the desired level of protection, and that its measures need to be consistent with the principle of national treatment.

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In setting their sanitary measures, importing countries need to make judgments regarding the quality of the Veterinary Services of an exporting country, including the ability to report on its animal health situation accurately and to implement OIE standards effectively. Such judgments will form part of the decision making process regarding whether the measures in the Terrestrial Code are appropriate for a particular situation. Such judgements may also affect the range of commodities considered to be at risk from the pathogenic agent, for example if there is a lack of confidence that the exporting country would be able of keep separate potential contaminants of raw materials.

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The Terrestrial Code also describes the obligations of the importing and exporting country with regard to 'national treatment', timeliness, information accuracy and certification.

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A typical disease chapter in the Terrestrial Code has the following structure:

brief descriptive of the disease or the pathogenic agent;

discussion of factors relevant to a risk assessment;

listing of ‘safe' commodities or 'unsafe' commodities;

criteria for differentiating animal health status (free from infection, free from disease with vaccination, moderate risk); and

requirements for importation or transit of ‘unsafe' commodities.

Listing 'safe' and 'unsafe' commodities

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When there is sufficient information for a particular pathogenic agent for the experts to conclude that certain commodities cannot be a source of infection, and that trade in them would be safe no matter the status of the exporting country for that pathogenic agent, those commodities are listed as safe commodities. In some chapters, the list reflects those commodities for which health measures are recommended. Some examples follow.

Chapter 2.1.9 (bluetongue (BTV)) states:

"Veterinary Administrations of countries shall consider whether there is a risk with regard to BTV infection in accepting importation or transit through their territory, from other countries, of the following commodities:

1) ruminants and other BTV susceptible herbivores;

2) semen of these species;

3) embryos/ova of these species;

4) pathological material and biological products (from these species) …

Other commodities should be considered as not having the potential to spread BTV when they are the subject of international trade."

Chapter 2.3.13 (bovine spongiform encephalopathy [BSE]) states:

"Regardless of the BSE status of the exporting country, Veterinary Administrations should authorise without restriction the import or transit through their territory of the following commodities:

milk and milk products;
semen and in vivo derived cattle embryos collected and handled in accordance with the recommendations of the International Embryo Transfer Society;
protein-free tallow (maximum level of insoluble impurities of 0.15% in weight) and derivatives made from this tallow;
dicalcium phosphate (with no trace of protein or fat);
hides and skins;
gelatin and collagen prepared exclusively from hides and skins."

Addressing 'unsafe' commodities

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For many diseases where distinctions can be made in the animal health status of exporting countries, a graded series of measures is recommended, reflecting the likelihood of the commodity being contaminated, and to minimize unjustified barriers to trade. For example, the chapter on classical swine fever (CSF) 2.1.13 lists the following exporting country health status levels:

countries or zones free of CSF in domestic and wild pigs;

countries or zones free of CSF in domestic pigs but with infection in wild;

countries or zones with CSF infection in domestic pigs.

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For each status level, specific recommendations are made for the following commodities: domestic pigs, wild pigs, semen, embryos, fresh meat, meat products and bristles.

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The foot and mouth disease (FMD) chapter (Chapter 2.1.1) provides recommendations for trade in various commodities from countries of different FMD status, and these recommendations increase in severity as the health status of the exporting country presents a greater likelihood of disease transfer with the commodity. For example, for frozen semen from non-vaccinating FMD-free countries or zones, there are minimal restrictions; for frozen semen from vaccinating FMD-free countries or zones, there are additional restrictions to ensure that vaccination does not mask infection in the donor animals; for import from infected countries or zones, the measures are more severe but semen may still be traded safely if these measures are followed.

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The chapter on BSE (2.3.13) describes five levels of exporting country status (free, provisionally free, minimal risk, moderate risk and high risk) and addresses trade in various commodities through an increasing grade of restrictions commensurate with the risks presented. For example, fresh meat may be imported safely from a country of any BSE status but with increasing restrictions so that, for countries presenting a high BSE risk, more severe measures are applied to the cattle from which the meat was derived and to the meat itself. The experts consider however that, if these measures are followed, the meat is safe.

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For some commodities, however, the experts have determined that particular commodities should not be exported even from countries presenting a low BSE risk; for example:

" ... ruminant-derived meat-and-bone meal or greaves, or any commodities containing such products, which originate from countries with a minimal, moderate or high BSE risk should not be traded between countries."

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The recommendations in the Terrestrial Code thereby provide Member Countries with the ability to engage in trade by making risk-based determinations without endangering their public and animal health nor applying unnecessary trade restrictions.

Implementing standards

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The Terrestrial Code notes that:

"The SPS Agreement encourages WTO Members to base their sanitary measures on international standards, guidelines and recommendations, where they exist. Members may choose to adopt a higher level of protection than that provided by international texts if there is a scientific justification or if the level of protection provided by the relevant international texts is considered to be inappropriate. In such circumstances, Members are subject to obligations relating to risk assessment and to a consistent approach of risk management."

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It is apparent that some Member Countries are applying trade bans when an exporting country reports the presence of a significant disease, without consulting the recommendations in the Terrestrial Code or conducting a risk analysis in accordance with its SPS obligations. Only very rarely does the Terrestrial Code recommend a ban on animals or specific animal products coming from an infected country, including FMD infected countries or those considered as having a 'high BSE risk'. The Terrestrial Code provides increasingly restrictive recommendations which are commensurate with the level of risk in each of the country status categories.

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Regarding the 2001 outbreaks of FMD, the BSE situation in the EU and the recent BSE cases in Japan and Canada, the existence of a valid up-to-date standard did not prevent major trade disruptions due to a failure by many countries to apply the international standard when developing or revising their import policies. This was particularly evident in the case of commodities for which the Terrestrial Code recommends that no restrictions be applied, regardless of the FMD or BSE status of the exporting country. For example, it is of concern that many countries apply trade bans when an exporting country reports its first case of BSE, without having conducted a risk analysis as described in the Terrestrial Code. Such situations penalise countries with a good and transparent surveillance system for animal diseases and zoonoses, and which have demonstrated their ability to control the risks identified through a risk assessment. This may result in a reluctance to report future cases and an increased likelihood of disease spread internationally.

Obligations in notifying measures

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Article 7 of the SPS Agreement states:

"Members shall notify changes in their sanitary or phytosanitary measures and shall provide information on their sanitary or phytosanitary measures in accordance with the provisions of Annex B."

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Annex B, paragraph 5, states:

"Whenever an international standard, guideline or recommendation does not exist or the content of a proposed sanitary or phytosanitary regulation is not substantially the same as the content of an international standard, guideline or recommendation, and if the regulation may have a significant effect on trade of other Members, Members shall:

(a) …

(b) …

(c) provide upon request to other Members copies of the proposed regulation and, whenever possible, identify the parts which in substance deviate from international standards, guidelines or recommendations;

(d) … ".

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Under the obligations as a Member of the WTO, a country introducing a measure which is substantially the same as an OIE standard does not need to notify other Member Countries. It is concerned, however, that Member Countries, in notifying new or revised measures, are including references to OIE's international standards incorrectly in the "International standard, guideline or recommendation" (in box n.8 in the Notification template or box n.9 in the Notification of Emergency Measures template).

BSE as an example

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In the first 7 months of 2003, notifications relating to BSE cases reported in Canada, Israel and the EU contained the following references:

Commodities covered by the notification	Reference within OIE's standards	Comment
Beef and beef products, and ruminants.	Terrestrial Code Chapter 2.3.13	BSE chapter refers only to cattle and products derived from cattle.
Bovine animals, goats and buffaloes and the ova, embryos, products and by-products thereof.	None	BSE chapter refers only to cattle and products derived from cattle; according to the Terrestrial Code, some commodities listed should not have restrictions applied.
Live ruminants, embryos and products derived from these species, including meat and offals, blood by products, blood meal, meat meal, bone meal, autoclave processed bone, meal as residues from slaughterhouses, meal from poultry viscera, meal from poultry feathers, meal from residues from poultry slaughterhouses or any ingredient or raw material which contains viscera from animals fed with proteins or fat from ruminants. Milk, dairy products, collagen obtained from skins and heat treated bone meal are excluded.	None	BSE chapter refers only to cattle and products derived from cattle; according to the Terrestrial Code, some commodities listed should not have restrictions applied.
Meat and meat by-products of bovine origin and food products containing tissues of bovine origin.	None	According to the Terrestrial Code, some commodities listed should not have restrictions applied.
Bovine animals and products of bovine origin.	None	According to the Terrestrial Code, some commodities listed should not have restrictions applied.
Cattle, semen, meat and meat products including products intended for animal feed and for agricultural and industrial use.	None	According to the Terrestrial Code, some commodities listed should not have restrictions applied.
Live cattle, all beef and beef products including animal feed and other products containing rendered meat or meat and bone meal.	Terrestrial Code Chapter 2.3.13	According to the Terrestrial Code, some commodities listed should not have restrictions applied.

The OIE in-house procedure for dispute mediation

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Subject to the agreement of both parties, disputing countries can request mediation by a panel of independent experts selected by the Director General of the OIE. This process has several advantages, as it is not as resource-demanding as the formal WTO process and allows for technically-based solutions. At the end of the process, the recommendations from the panel are communicated by the Director General to both parties.

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While this process is confidential and non-binding, should the case eventually result in a formal dispute at the WTO, the documentation from this mediation may be released by either party for use by the WTO.

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