Background
The Cartagena
Protocol on Biosafety is the first (only) global agreement on genetically
modified organisms. The Protocol's diplomatic origins can be traced to the
1992 Summit of the UN Conference of Environment and Development, held in
Rio de Janeiro, Brazil. The Conference concluded with the adoption of four
international agreements on environment, among these the Convention on Biological
Diversity (CBD), whose objective is the conservation and sustainable use
of biological diversity and the fair and equitable sharing of the benefits
arising out of the utilization of genetic resources.
In the negotiation of the CBD, sharp lines were drawn between developing countries (where most of the world's biological diversity is located) and governments of the North, whose interest lay in maintaining inexpensive and easy access to biological resources. The late 1980s and early 90s surge of concern in Europe and the US about tropical forests and animals was not necessarily viewed as friendly in biodiverse developing countries.[16] The authorization of utility patents on DNA, microorganisms, plants and animals in the United States led to bitter battles as biodiverse countries, often backed by NGOs, sought to protect their interests in the face of emerging intellectual property protections that permitted privatization of biological resources (also discussed in the then under-negotiation WTO agreement).
The compromise that was struck pleased most governments and some environmental NGOs, the latter of which were, at the time, convinced that marketing natural products through "bioprospecting" and other commercial efforts would benefit biodiversity. Some politically-influential constituencies were less certain, including a number of developing countries, advocates for farmers, opponents of life patenting, and many indigenous peoples. They feared that the CBD's enshrinement of national sovereignty over biological diversity coupled with its provisions on access to and patenting of biodiversity would prove destructive to community rights and resources.[17]
Nearly universal, the CBD has 187 parties. The United States, which signed the CBD in Rio in 1992, remains the only industrialized country that has not ratified it. While the Clinton administration officially supported ratification, a concerted effort was not undertaken in the US Senate. Today, the US retains reservations that the CBD impairs its commercial interests. Despite being only a signatory, the US is a vocal and sometimes aggressive player in CBD negotiations.
The Convention operates under the UN Environment Programme (UNEP), headquartered in Nairobi, Kenya. The CBD Secretariat is located in Montreal, Canada. The CBD Conference of the Parties (COP) takes place every one and a half to two years and informally rotates between major (bio)geographic regions.[18] A Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) usually meets in Montreal and provides technical input. It and the COP sometimes address topics of relevance to the Biological Weapons Convention, such as biological control and invasive alien species.
The Cartagena
Protocol
The Cartagena Biosafety Protocol on genetically modified organisms prohibits
the introduction of a GMO into a country without that country's consent.
It arises from Article 19.3 of the CBD, which instructed the Parties to
"consider the need for and modalities of a protocol setting out
appropriate procedures, including, in particular, advance informed agreement,
in the field of the safe transfer, handling and use of any living modified
organism resulting from biotechnology that may have adverse effect on the
conservation and sustainable use of biological diversity".
The road towards the adoption of the Protocol was a bumpy one. The negotiations formally started in 1995 with the adoption of Decision II/5 at the 2nd Conference of the Parties of the CBD in Jakarta, Indonesia. That decision created of an Open-ended Ad Hoc Group on Biosafety, whose mission was to draft a protocol on Biosafety.
The negotiations lasted five years and, on several occasions, nearly collapsed. The Protocol is named for the city of Cartagena (Colombia), where it was hoped that Protocol text would be finished in 1999. However, differences prompted adjournment of the Cartagena meeting without an agreement. The following year one was finally reached in Montreal. The Protocol required fifty ratifications for entry into force. Palau's ratification on June 13, 2003 set the day of entry to force on September 11, 2003. Presently there are 63 parties.
During the negotiation of the Protocol, states aligned themselves around two opposing groups. Led by the United States were the major exporters of genetically modified organisms (GMOs) for food with allied agricultural exporters whose potential future interests included relatively unrestricted international movement of GMOs. Joining the US were Argentina, Australia, Chile, Canada and Uruguay, forming the "Miami Group". Opposing this small but powerful group was the much larger "Like Minded Group of Developing Countries", led by Ethiopia. As potential importers of biotechnology products and hosts of greater part of the world's biodiversity, the Like Minded Group felt vulnerable to the environmental and socio-economic impacts of GMOs and wished to establish a comprehensive regulatory framework. In the endgame of the negotiations, the European Union's position was, generally, supportive of the Like Minded Group, lending additional pressure to finalize the agreement.
Main features
The Protocol
reaffirms the Precautionary Approach, adopted as a principle in the 1992
Rio Declaration on Environment and Development. It mandates that when facing
a threat to the environment, the lack of scientific certainty due to insufficient
scientific information and knowledge shall not prevent States from taking
action in order to avoid or minimize adverse effects of the threat[19].
This approach acquires particular relevance in the case of GMOs, whose safety
is vigorously debated worldwide.
Although the Protocol is basically an environmental instrument, it includes within its objective the protection from possible impacts of GMOs on human health. The Protocol recognizes that there are intrinsic risks associated with GMOs - both to the environment and human health - and promotes biosafety by setting the rules for the safe transfer, handling and use of GMOs, focusing on the transboundary movement of GMOs intended for the release into the environment.[20]
Scope: The scope of the Protocol is limited, reflecting the compromise between opposing groups. It applies the core of its provisions to 'living modified organisms"[21] intended for field release, and applies to a different, lesser, extent to other GMOs, such as for those intended for direct use as food or feed. The distinction was made in response to the Miami Group's demand to exclude products derived from GMOs (e.g. oil or starch from genetically modified crops). The Protocol applies to mainly to the transboundary movement of all LMOs, and has less restrictive provisions for the transit, handling and use of LMOs.
Also excluded from the main provisions of the Protocol are GMOs that are pharmaceuticals for humans (Art. 5) because it was argued by Miami Group countries that they are addressed by other international agreements or organizations. This exclusion has yet to take practical effect because presently there are no international agreements that specifically address safety of human pharmaceutical GMOs (e.g. "gene therapy" products, which remain experimental). As a result, many countries, including the Africa Group, maintain that the Cartagena Biosafety Protocol applies to GMO pharmaceuticals in the interim. Biotech pharmaceuticals for animals are covered by the Protocol.
Advanced Informed Agreement (AIA): The core provision set up by the Protocol is the requirement by the exporter of LMOs to obtain prior advanced informed agreement from the importer before the "first international transboundary movement of LMOs intended for intentional introduction into the environment of the party of import" takes place. In other words, it is prohibited for one country to introduce a LMO into another without that country's consent. This requirement means that a party can, legally, refuse the introduction of any LMO that it considers a threat to its biological diversity or human health. Annex I of the Protocol details the minimum information that the exporter must submit to the importer (the notification).
Risk assessment and management: The decisions of importing parties to allow or refuse the introduction of LMOs must be based on risk assessment. The Protocol provides the guidelines that the assessments must follow. The assessment must take into consideration the information provided by the exporter as well as the other scientific evidence available "in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biodiversity, taking also into account risks to human health." (Art. 15). Annex III of the Protocol provides guidelines and methodologies for conducting risk assessments.
Additionally, all Parties are obliged to establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment. Among these, countries must take measures to prevent unintentionally transboundary movement of LMOs.
Limited regulations: While the Protocol focuses on the transboundary movement of LMOs intended for planting in fields, it does not exclude from its scope LMOs intended for other uses, such as food and feed, rather, it establishes a less restrictive set of regulations for them.
GMOs that are in transit or intended for contained use (i.e. laboratory utilization) are exempted from the AIA requirement, however, states have the right to regulate the transit of such GMOs through their territories, to require a risk assessment prior the importation of any GMO, and to set standards for contained use (i.e. laboratory biosafety). GMOs that are intended for direct use as food or feed, or for processing must be labeled indicating that they "may contain" GMOs "and are not intended for intentional introduction into the environment, as well as a contact point for further information" (Art. 18).
The Protocol establishes a minimal requirement for all LMOs that countries must approve for domestic use, including placing on the market, whenever those organisms "may be subject to transboundary movement, as well as for those intended for direct use as food, processing or feed. In such cases, countries must make available the decision by which such use was authorized by the producing country at the "Biosafety Clearing-House", an internet based information sharing mechanism (Art. 11). Annex II of the Protocol lists the minimal information that must be made available at the Biosafety Clearing House, providing potential importers a means to begin their decision-making process on introduction of GMOs within their boundaries
National authorities: Parties are required to designate national authorities responsible to carry out the obligations set up by the Protocol and to serve as liaison with the Secretariat of the Protocol. Parties have to notify the Secretariat the name and contact information of such authorities (Art. 19). Minimally, the national authority must be legally-enabled to carry out the import/export requirements of the Protocol.
While establishing national authorities, many countries, especially developing countries, are setting up more comprehensive domestic biosafety legislation. These processes present opportunities to specifically address hostile use of GMOs and will lead to the establishment of focal points of expertise in biotechnology risk assessment and management in member states. In Africa, for example, a Model Law on biosafety to implement the Cartagena Protocol has been developed and adopted by the African Union, for national implementation in member states. This Model Law includes criminal penalties for deliberate abuse of genetically modified organisms.
Secretariat and Conference of the Parties: The governing body of the Protocol is its Conference of Parties, whose responsibility is to review implementation and to take the decisions necessary to promote effective implementation. Only Parties to the Protocol are entitled to fully participate. Non-parties may attend as observers. The Secretariat of the Convention on Biological Diversity serves also as Secretariat of the Protocol (Art. 31).
Compliance, Liability and Redress: The issues of compliance and of liability for damages resulting from transboundary movement of GMOs were ones on which the Parties could not reach agreement during the negotiation of the Protocol. Instead, they decided to defer until the first Conference of the Parties (Art. 34 and 27). The first Conference of the Parties of the Members of the Protocol will take place in Kuala Lumpur from 23-27 February 2004, and compliance, liability and redress are on the agenda.[22]
Recommendations
With
the entry into force of the Cartagena Protocol, the development of concrete
links between it and the BWC has become more possible. The Cartagena Protocol
will face challenges in its early meetings, including what promise to be
difficult negotiations over liability and redress and the potentially less
than constructive participation of some observer countries. First steps
that can be taken by the BWC and/or the Cartagena Protocol include:
Internationally...
the Conference of the Parties to the Cartagena Protocol may request observer status for the Protocol at meetings of the Biological Weapons Convention;
governments should nominate persons with expertise in biological weapons control to the Protocol's Roster of Experts and support their participation in Protocol activities;[23]
training courses and capacity building for the Cartagena Biosafety Protocol - currently underway on a large scale - should include components on the BWC and biological weapons control;
the Conference of the Parties to the Cartagena Protocol should explore the Protocol's relationships with the BWC by
a) requesting that the Secretariat study how the Protocol's requirements on transboundary movement of LMOs relate to non-proliferation of biological weapons and,
b) developing tools to integrate criteria related to the potential for hostile use of LMOs into the process of risk assessment under the Protocol;
likewise, States Parties to the BWC may request the BWC Secretariat to prepare a study on the relationships between the BWC and the Cartagena Protocol.
Nationally, governments may...
assess how financial and technical support for Cartagena Protocol capacity building programs can increase awareness and help countries fullfill obligations under the BWC;
implement the Biosafety Protocol with the provisions of the BWC (particularly Article IV) in mind and, to the maximum extent possible, within a linked legal framework;
adopt biosafety law that establishes criminal penalties for the deliberate abuse (hostile use) of GMOs. These penalties should apply to all persons, including individuals, government officials (in private and official capacities), corporations, and other organizations;
integrate criteria related to the potential for hostile use of LMOs into the process of risk assessment under the Protocol.
IV The International Plant Protection Convention
Background
The main
international phytosanitary (i.e plant health) agreement, the International
Plant Protection Convention (IPPC) was negotiated under the auspices of
the United Nations Food and Agriculture Organization (FAO). It seeks international
cooperation to prevent the introduction and spread of pests of plants and
products and to control such pests. Adopted in 1951, the IPPC entered into
forced in April 1952. The original Convention was also referred to as "Phytosanitary
Certificate", because its main feature was the provision of a form
issued by Parties to exporters of plants and plants products to certify
that exports were free of organisms designated as plant pests by
importing countries[24]
Since its adoption more than a half-century ago, two major revisions have been made to the text of the Convention. The first revision process started in 1973 and was adopted in 1979. The revision aimed, in essence, to update the terminology of the Convention, to more clearly define the obligations of Parties, and to update the Phytosanitary Certificate.[25] For example, in the 1979 revision, terms such as "pests" and "containers" were defined. The revised text added a model for a new certificate for "re-export" of plants and plant products (Art. V). This first revision entered into force for all contracting parties in 1991, after it was accepted by two thirds of the parties to the original IPPC.
A second revision process was triggered by the 1994 conclusion of the Uruguay Round of multilateral trade negotiations, which gave rise to the World Trade Organization. Along with the creation of WTO, an Agreement on Sanitary and Phytosanitary Measures - the SPS Agreement - was adopted in 1994. The SPS Agreement sets the basic rules for food safety and animal and plant health standards with the objective of preventing countries from using sanitary and phytosanitary regulations as trade barriers. It does so by encouraging the development and adoption of international standards, a process known as "harmonization". Countries retain the right to depart from international standards and adopt their own health regulations; but those regulations must be based on science and justified by circumstances.[26]
The standard setting required by the SPS harmonization process is not carried out by the WTO, but by a set of specialized international agreements. These currently are the standards-stetting bodies known as the "three sisters", namely the joint FAO-WHO Codex Alimentarius (food safety), the IPPC (plant health), and the OIE (animal health)[27] New standards-setting bodies may be named, provided that membership in them is open to all WTO members.
The second revision to IPPC was directed specifically to fulfill the new role assigned to it by WTO, particularly standard setting. The revision negotiations started in 1995 and were concluded in November 1997, when the FAO Conference approved a revised text. This latest text has not entered into force. Like its predecessor, the 1997 IPPC requires acceptance of two-thirds of contracting Parties in order to enter into force. Only 45 countries have done so to date[28]. An additional problem is that it has proven difficult to reach consensus on how many countries make up the two-thirds required, since the number of parties is in flux. New countries joining the IPPC have usually but not always agreed to accept the new text, while in the 1990s some older state parties disappeared or divided into new ones.
Nevertheless, some provisions from the 1997 version have come into play early because of interim measures adopted by the Parties, including the amendments made to the phytosanitary and re-export certificates; the establishment of an Interim Commission on Phytosanitary Measures (ICPM), the adoption of its terms of reference; and approved interpretations of various articles[29].
Purpose: Defined in Article I, the purpose is "securing common and effective action to prevent the spread and introduction of pests of plants and plant products, and to promote appropriate measures for their control". The 1997 version adds text stating that nothing in IPPC will compromise the obligations of parties under other international agreements, a reference to SPS and other WTO obligations.
Scope The IPPC applies to plants and plant products, as well as storage places, containers, packing material, soil and - in the 1997 version - "any other organism, object or material capable of harboring or spreading pests, deemed to require phytosanitary measures, particularly where international transportation is involved".
Like the 1979 IPPC, the 1997 revision undertook to clarify terms used in the Convention. The 1979 revision added a definition of pest -"any pathogenic agent, injurious or potentially injurious to plants and plant products". This definition was further elaborated in the revised text of 1997, to include also "any species, strain or biotype, animal or pathogenic agent" injurious to plants or plant products.
The definition of plants was also widened in the 1997 version, adding "germplasm" and extending the scope of protection to wild flora (Art IV). The aim was to provide a comprehensive framework for dealing with issues of plant protection, including aspects of environmental protection. This new wider scope has increased the relevance of the IPPC to issues such as invasive alien species and biosafety, both of which are also issues addressed under the Convention on Biological Diversity[30] and are relevant to the BWC.
National Plant Protection Organization (NPPO): The Convention calls for the designation of a NPPO to be responsible for the core obligations assumed by states under the IPPC, among them (Art. IV):
In 1979 the issuance of re-export certificates was added and, in 1997, "the protection of endangered areas and the designation, maintenance and surveillance of pest free areas and areas of low prevalence", and "the conduct of pest risk assessments" were added. NPPOs are currently registering and reporting pest outbreaks which may be also of relevance to the BWC where under the 1992 Confidence Building Measures (CBMs) an "exchange of information on outbreaks of infectious diseases ... that seem to deviate from the normal pattern "[31] (CBM B) is taking place.
Control over imports: One of the main features of the IPPC is the regulation of Parties' right to control imports of materials that might introduce or spread pests within their territories. The original IPPC text granted Parties the right to place restrictions and requirements on the importation of plants and products; prohibit the importation of particular plants and plant products; detain particular consignments; and even "treat, destroy or refuse entry to particular consignment of plants and products, or require such consignments to be treated or destroyed" (Art. VI of 1959 and 1979 texts[32]). In 1979, those rights were pared down to allow the destruction and refusal of entry only to consignments that entered in violation of importing country's existing regulations. Parties were also to "list pests the introduction of which is prohibited or restricted because they are of potential economic importance to the country concerned".
The aim of those 1997 changes was to limit Parties' ability to regulate imports under the SPS Agreement. While parties still have the right to adopt phytosanitary measures, including prohibiting or restricting entry of consignments, and to require that consignments be treated before entrance, a set of limitations has been imposed on exercising those rights. Among them: all actions must be based on phytosanitary measures that are "technically justified"; parties must publicize their phytosanitary regulations immediately after adoption; other parties may request the rationale behind phytosanitary measures, and importing countries must report to concerned exporting countries cases of non-compliance with phytosanitary certification. Under SPS, failure to technically justify phytosanitary measures provides grounds to challenge them (see "US Bioterrorism Law Collides with the WTO", p. XX).
Importation of biological agents is covered under the regulations of importation of plants (Art. VI, VII in the 1997 version). The 1951 text granted the right to countries to make provisions for the importation "for purposes of scientific research of plants and plant products and of specimens of plants pests and disease causing organisms under conditions affording ample precaution against the risk of spreading plants diseases and pest". In 1979 education was added to the purposes for which importation of disease causing organisms, and a reference to biological control was introduced: "Adequate safeguards likewise need to be taken when introducing biological control agents and organisms claimed to be beneficial".
In 1997, the purposes for importing biological agents were further widened as was the scope of biological material: "Nothing in this article shall prevent importing contracting parties from making special provision, subject to adequate safeguards, for the importation, for the purpose of scientific research, education, or other specific use, of plants and plant products and other regulated articles, and of plant pests." (Emphasis added on new 1997 additions.)
Standard setting process: Although a standards process was started within IPPC in 1990 and the first set of international standards were approved in 1993 by a FAO Conference resolution, the standard setting process is formally established in the (as yet not-in-force) 1997 IPPC revision.[33]
The 1997 version also creates the Commission on Phytosanitary Measures as the IPPC's decision-making organ and the body responsible for the adoption of standards. Membership in the Commission is open to all contracting parties. Because the Commission cannot be officially constituted until the new text enters into force, however, the "Interim Commission on Phytosanitary Measures" (ICPM) serves until the amendments come into force. The ICPM is open to all FAO members, as it was established under the provisions of the FAO Constitution and Basic Texts.
As such, IPPC Parties are not currently obliged to follow the ICPM's international standards, although they are strongly encouraged to do so. A Party may choose to establish protection levels above the international standards, in which case it has to provide scientific justification. In such cases, Parties must also inform other Parties possibly affected by the measures. This new provision goes along with SPS's requirement that phytosanitary measures be applied for no purpose other than that of ensuring plant health; indeed, SPS further requires that regulations are applied in such way that they do not result in unfair or disguised restrictions on trade.
The drafting of the standards themselves can take place at the IPPC's Secretariat, or at any of the expert groups organized by the Secretariat. They may originate as national or regional initiatives. The ICPM reviews draft standards and circulates them among Parties prior to adoption. So far, 19 standards have been adopted by the ICPM, and more are under consideration. Among the notable adopted standards are No. 3: "Code of Conduct for the import and release of exotic biological control agents", which covers importation of exotic biological control agents capable of self-replication, outlining responsibilities for both importer and exporter countries, before the importation, during the exportation and after the release; and No. 11: "Pest Risk Analysis for Quarantine Pests".[34] Drafts currently under consideration include a supplement to No. 11 on genetically modified organisms.
Settlement of Disputes: In the original IPPC, the procedure for settlement of disputes was to request the Director-General of FAO to appoint a committee of experts to consider the question in dispute. The Committee, which would also include representatives from the countries in dispute, would produce a report and send it to the Director-General, who in turn, transmitted it to the parties in dispute and other parties. The Committee's recommendations, while not binding, constituted a basis for renewed consideration by the feuding parties.
The text of 1997 establishes, as first resort (prior to discussion at WTO SPS), an opportunity for the concerned parties to consult among themselves with a view to resolving the dispute. If the dispute cannot be resolved through direct consultation, one of the parties or all parties concerned may request FAO Director-General to appoint the expert committee. The newly created Commission is charged with the task of approving the rules and procedures that must be followed by any expert committee in the preparation of their report. Finally, the 1997 text highlights that IPPC settlement of disputes "shall be complementary and not in derogation of the dispute settlement procedures provided for in other international agreements dealing with trade matters", a clear reference to WTO procedures. The Interim Commission has established a subsidiary body for dispute resolution, although the interest of states parties to date has been rather limited.
Discussion:
Future IPPC Standards
Unlike
its "sisters" OIE (1924) and Codex Alimentarius (1964), IPPC is
new to setting international standards, having only received a mandate to
do so as a result of the SPS agreement. Presently the IPPC adopts an average
of two new standards per year. Some Parties (particularly developed countries)
wish to increase the Secretariat's budget and staff in order to increase
the rate of standard adoption. Some Parties, such as the US, propose procedures
to facilitate adoption of draft standards developed outside of the IPPC.
Other Parties prefer a slower approach, in large measure because of the
IPPC's relationship to SPS, where many developing countries feel the cards
are stacked against them in the event of a dispute with a larger power.
Many of the same countries are unenthusiastic about "outsourcing"
the standards-drafting process if it affords undue influence to industry,
which might develop standards itself and then have them shepherded through
the IPPC by a friendly government.
In November 2002, the ICPM polled countries on their suggestions for new international standards.[35] Among the suggestions were new standards on detection, monitoring, and control of a number of pathogens of BW (and economic) concern, including plum pox potyvirus, Xanthomonas and Ralstonias bacteria, fungi including Tilletia (karnal bunt), Synchytrium endobioticum (potato wart disease) and types of Fusarium oxysporum, as well as insects that are plant pests, such as Thrips palmi. The IPPC may also consider specific biotechnology risks, such as adoption of standards on herbicide and insect resistant crops as pests, which presently exist as draft guidelines authored by the FAO Plant Protection Service.
Of particular interest in limiting broader BW-related risks are IPPC "concept" standards, which relate not to specific pests; but to procedures, methods, regulations, and facilities for controlling plant pests more generally. Concept standards have been proposed for identification of plant pests, for monitoring and surveillance, and for high security (i.e. biocontainment) quarantine facilities.
V Office International des Epizooties (OIE)
Background
Based
in Paris, the Office International des Epizooties (world animal health organization)
focuses on preventing the spread of animal diseases, including zoonoses
(animal diseases that can also be transmitted to humans), while enabling
international trade of animals and animal products. OIE came about in the
aftermath of a 1920 outbreak of rinderpest in Belgium, which was caused
when infected cattle passed through the port of Antwerp. The episode prompted
the negotiation of an international agreement that was adopted in 1924 by
28 countries in the League of Nations.
The 1924 agreement establishing OIE provided a framework upon which its work has evolved. The obligations contained in the Agreement are basic: contracting parties agree to the creation of the Office, based in Paris; they established a decision making body that has authority over the office; a Committee comprised of delegates of contracting parties; and a flexible scheme to make any changes that parties consider necessary, provided it is done by consensus.
The statues for the OIE were appended to the Agreement and outline the office's main objectives, elaborate the Committee's rules, and included some additional obligations for contracting parties.
Article 4 of the statutes established the main objectives of the Office as:
"a. To promote and co-ordinate all experimental and other research work concerning the pathology or prophylaxis of contagious diseases of livestock for which international collaboration is deemed desirable.
b. To collect and bring to the attention of the Governments or their sanitary services, all facts and documents of general interest concerning the spread of epizootic diseases and the means used to control them.
c. To examine international draft agreements regarding animal sanitary measures and to provide signatory Governments with the means of supervising their enforcement."
In turn, Parties committed themselves to inform the OIE immediately if any outbreaks of rinderpest or foot and mouth disease (FMD) occurred in their territories and to periodically report on the presence and distribution of certain diseases. The list of diseases may be modified by Parties at any time. Additionally, Parties must submit to OIE the regulations they adopt to protect against animal diseases, particularly those that apply to imports (Art. 5).
Thus, the OIE is a versatile organization that works on several fronts simultaneously: it adopts standards on animal health to be applied to international trade of animals and animal products (these are recognized by WTO SPS agreement); it collects and disseminates among members information on animal diseases outbreaks; it promotes research on ianimal diseases and disseminates relevant scientific information; and it provides a framework for international cooperation for the control of animal diseases.
Standards and Manuals: The most important collection of OIE sanitary standards are the Terrestrial Animal Health Code and the Aquatic Animal Health Code, aimed at preventing the introduction of infection agents and diseases pathogenic to animals and humans through the international trade of animals, animal genetic material and animal products. As standards, the codes also have a major role in preventing parties from using animal sanitary measures as trade barriers.
The terrestrial and aquatic codes, as they are known,
are periodically updated through revisions carried out by OIE specialist
commissions. The commissions are composed of experts in the field, and revisions
to the text are approved by OIE's Committee following consultations among
delegates. Each code is published English, Spanish, and French, which are
the OIE's only official languages. The Terrestrial Code has been translated
into Russian.
The codes contain a list of definitions, disease notification criteria, procedures for international reporting of diseases, principles for import risk analysis, the organization of import and export procedures. Both codes include a list of priority transmissible animal diseases, but in case of terrestrial animals, they are divided into categories A and B. In List A are transmissible diseases "which have the potential for very serious and rapid spread". Countries must report the occurrence of these diseases promptly, following the guidelines provided of the Code. List B includes eighty transmissible diseases that are not regarded as sever a threat for rapid spread as those contained in List A, but which are of economic importance.[36] Parties must report on the status of List B diseases annually following the guidelines provided in the Code. The Acquatic Code lists 35 diseases of fish, molluscs, and crustaceans and also includes reporting requirements.
Emergency reports of List A disease outbreaks filed by the veterinary authorities of member countries are posted by OIE in a weekly publication, Disease Information, which is available online.[37] Annual data on outbreaks of List B diseases, including zoonoses such as anthrax, brucella, and types of equine encephalitis, are published in the annual report World Anmal Health. A database, Handistat II, lists this information online; but is described as a "prototype" and is not up to date.The Terrestrial Code provides general standards for risk analysis (for import/export) followed by specific definitions and criteria for each List A and B disease. Both codes contain a series of models of international veterinary certificates, aimed at assisting in harmonization process mandated by the WTO SPS Agreement.
Additionally, the terrestrial code includes appendices with recommendations for collection and handling of semen and embryos, sanitation of hatcheries and incubators and transport of animals, along with standards for the epidemiological surveillance of some animal diseases. The Aquatic Code also has appendices that include recommendations on health control and hygiene.
Scope: Although OIE focuses on the spread of animal diseases and zoonoses due to international movement of animal and animal products, its scope is wider, to include, besides traditional animal products, biologicals for veterinary use and, in general, any product capable of carrying animal diseases and zoonoses. The Terrestrial Code states (Part 1, Chapter 1.5.1):
All products, including biologicals for veterinary use, derived from animals have some capacity to transmit animal disease. The level of this capacity depends on the inherent nature of the products, their source, the treatment that they might have undergone, and the purpose for which they are intended. Biologicals for in vivo use in particular will have the highest probability of exposure to animals and as such present the highest risk. Products used for in vitro purposes can introduce disease into animal populations through deliberate or inadvertent use in vivo, contamination of other biologicals, or spread by other means. Even products for diagnosis and research have the potential for close contact with animals. Exotic micro-organisms, some highly pathogenic, which may be held for research and diagnostic purposes in countries free from infection or the diseases they cause, could possibly contaminate other biological products. Veterinary Administrations of importing countries shall make available specific procedural requirements for approval or licensing of biologicals for veterinary use. They may limit supply to registered institutions or in vitrouse or for non-veterinary purposes where such assurance cannot be provided.
The Code addresses biologicals for veterinary use other than veterinary vaccines, including a number of types of laboratory and meidical supplies, such as preserved specimens, sera, cell lines, genetically-modified microorganisms (for veterinary use), etc. Countries are charged with carrying out risk analysis for all those products before international trade takes place, for which the manual provides guidelines.
To complement the standards, OIE has also developed two manuals: the Manual of Diagnostic Test and Vaccines for Terrestrial Animals and the Manual of Diagnostic Test for Aquatic Animals. The manuals provide standards for laboratory diagnostic tests and protocols, for the production of biological products for veterinary use, including vaccines; international transfer and laboratory containment of animal pathogens, and laboratory biosafety. These are published in English only.
Both standards and manuals are periodically revised and amended by Specialist Commissions.
Early Warning System: OIE, FAO and the World Health Organization (WHO) have been working, since the late 90s, on the development of an early warning system to provide alerts on the (potential for) outbreak of major epizootic diseases such as those on OIE List A.[38] Momentum for the system has been built by recent outbreaks of FMD in Europe; but also by diseases such as African swine fever, which FAO reports resulted in the loss of 50% of the West African pig population between 1996 and 1999. The system is surrently called the "Global Information and Early Warning System for Transboundary Animal Disease", and uses the unwieldy acronym "GIEWS-TADs".[39] In 2003, regional consultations on the system are planned in South Asia and Southeast Asia. The system is also being designed to have predictive capabilities and could also be used to detect and alert in cases of deliberate spread of diseases.