The PVS Critical Competencies Fundamental Component IV: Access to Markets Training Seminar: “The OIE PVS Tool” 16 – 20 April 2012 Beijing, China Dr. Ronel Abila Dr. Patrick Bastiaensen 1

CC IV-1 Preparation of legislation and regulations Glossary of terms Veterinary legislation means laws, regulations and all associated legal instruments that pertain to the veterinary domain. OIE Guidelines on veterinary legislation. OIE Guidelines on veterinary legislation (www.oie.int). Terrestrial Code reference Text of the guidelines to be introduced into the TAHC in May 2012, after adoption by the World Assembly of Delegates OIE PVS Pathway Veterinary Legislation Support Programme 2/Item13

CC IV-1 Preparation of legislation and regulations Background Veterinary legislation is an essential element of the national infrastructure that enables Veterinary Services to efficiently carry out their key functions, including epidemio-surveillance; early detection and reporting of diseases, including zoonoses; rapid response to and prevention and control of sanitary emergencies; animal production food safety; animal welfare and the certification of animals and animal products for export. 3/Item13

CC IV-1 Preparation of legislation and regulations Civil law Common law Bi-juridical (civil and common law) Customary law Islamic law (sharia) 4/Item13

CC IV-1 Preparation of legislation and regulations Background Internal quality principles of legal drafting and legal issues… External quality accessibility, acceptability, and technical, social and economical applicability… 5/Item13

Sub-regulatory domain CC IV-1 Preparation of legislation and regulations Background Sub-regulatory domain Regulations Legislations Constitution Internal quality Legislation = legislative power Regulation = executive power Treaties 6/Item13

CC IV-1 Preparation of legislation and regulations Background External quality Amounts to legislation which is : Relevant Acceptable Applicable Affordable … then effectively applied 7/Item13

Epidemio-surveillance, CC IV-1 Preparation of legislation and regulations Professions Pharmacy Transports, personnel, premisses… Crosscutting legislation: Animal Health Movement controls, Sanitary police; Epidemio-surveillance, Prophylaxies, … Special legislation: Abattoirs, eggs, catering… Zoonoses Food chain Welfare Waste Courtesy of M. Petitclerc 8/Item13

CC IV-1 Preparation of legislation and regulations Background Key issues to assess during PVS evaluations Internal quality ( a little … ) External quality ( a lot … ) Scope (animal health, public health, food safety, welfare,..) Definitions (vertebrates, invertebrates, birds, mammals) Competent authorities and chain of command Penal and administrative sanctions Legal authority of inspectors to …..inspect! Funding 9/Item13

IV-1 Preparation of legislation and regulations Levels of advancement The authority and capability of the VS to actively participate in the preparation of national legislation and regulations in domains that are under their mandate, in order to warranty its quality with respect to principles of legal drafting and legal issues (internal quality) and its accessibility, acceptability, and technical, social and economical applicability (external quality). Levels of advancement 1. The VS have neither the authority nor the capability to participate in the preparation of national legislation and regulations, which result in legislation that is lacking or is out-dated or of poor quality in most fields of VS activity. 2. The VS have the authority and the capability to participate in the preparation of national legislation and regulations and can largely ensure their internal quality, but the legislation and regulations are often lacking in external quality. 3. The VS have the authority and the capability to participate in the preparation of national legislation and regulations, with adequate internal and external quality in some fields of activity, but lack formal methodology to develop adequate national legislation and regulations regularly in all domains. 10/Item13

IV-1 Preparation of legislation and regulations Levels of advancement The authority and capability of the VS to actively participate in the preparation of national legislation and regulations in domains that are under their mandate, in order to warranty its quality with respect to principles of legal drafting and legal issues (internal quality) and its accessibility, acceptability, and technical, social and economical applicability (external quality). Levels of advancement 4. The VS have the authority and the capability to participate in the preparation of national legislation and regulations, with a relevant formal methodology to ensure adequate internal and external quality, involving stakeholder participation in most fields of activity. 5. The VS regularly evaluate and update their legislation and regulations to maintain relevance to evolving national and international contexts. 11/Item13

CC IV-2 Implementation of legislation and regulations and stakeholder compliance Background Implementation or law enforcement Internal / institutionnal Stakeholders : farmers, industry, consumers,… We assess the VS’  authority and capability to enforce the law with regard to stakeholders, not the compliance of the stakeholders themselves (this is outside the scope of the VS) 12/Item13

CC IV-2 Implementation of legislation and regulations and stakeholder compliance Background Key issues to assess during PVS evaluations Documented evidence of inspections Documented evidence of prosecution Ressource allocation : staff, means, authority We assess the VS’  authority and capability to enforce the law with regard to stakeholders, not the compliance of the stakeholders themselves but observing compliance amongst stakeholders is proof of the success or failure of the VS to enforce the law! 13/Item13

IV-2 Implementation of legislation and regulations and stakeholder compliance The authority and capability of the VS to ensure that stakeholders are in compliance with legislation and regulations under the VS mandate. Levels of advancement 1. The VS have no or very limited programmes or activities to ensure stakeholder compliance with relevant legislation and regulations. 2. The VS implement a programme or activities comprising inspection and verification of compliance with legislation and regulations and recording instances of non-compliance, but generally cannot or do not take further action in most relevant fields of activity. 3. Veterinary legislation is generally implemented. As required, the VS have a power to take legal action / initiate prosecution in instances of non-compliance in most relevant fields of activity. 4. Veterinary legislation is implemented in all domains of veterinary competence and the VS work with stakeholders to minimise instances of non-compliance. 5. The compliance programme is regularly subjected to audit by the VS or external agencies. 14/Item13

CC IV-3 International harmonisation Background Legislations The process by which international (or regional) treaties, standards and/or agreements are translated into national legislation, regulations and procedures in order to render it compliant. Treaties Upstream, the country or authority can be actively involved in the way these treaties, standards and agreements are being developed and come into force. 15/Item13

IV-3 International harmonisation The authority and capability of the VS to be active in the international harmonisation of regulations and sanitary measures and to ensure that the national legislation and regulations under their mandate take account of relevant international standards, as appropriate. Levels of advancement 1. National legislation, regulations and sanitary measures under the mandate of the VS do not take account of international standards. 2. The VS are aware of gaps, inconsistencies or non-conformities in national legislation, regulations and sanitary measures as compared to international standards, but do not have the capability or authority to rectify the problems. 3. The VS monitor the establishment of new and revised international standards, and periodically review national legislation, regulations and sanitary measures with the aim of harmonising them, as appropriate, with international standards, but do not actively comment on the draft standards of relevant intergovernmental organisations. 4. The VS are active in reviewing and commenting on the draft standards of relevant intergovernmental organisations. 5. The VS actively and regularly participate at the international level in the formulation, negotiation and adoption of international standards, and use the standards to harmonise national legislation, regulations and sanitary measures. 16/Item13

CC IV-4 International certification Glossary of terms International veterinary certificate means a certificate, issued in conformity with the provisions of Chapter 5.2., describing the animal health and/or public health requirements which are fulfilled by the exported commodities Official veterinarians means a veterinarian authorised by the Veterinary Authority of the country to perform certain designated official tasks associated with animal health and/or public health and inspections of commodities and, when appropriate, to certify in conformity with the provisions of Chapters 5.1. and 5.2. of the Terrestrial Code. 17/Item13

CC IV-4 International certification Terrestrial Code reference - Chapter 5.1: General obligations related to certification Article 5.1.1 To maximise harmonisation of the sanitary aspects of international trade, Veterinary Authorities of OIE Members should base their import requirements on the OIE standards. These requirements should be included in the model certificates approved by the OIE. Certification requirements should be exact and concise, and should clearly convey the wishes of the importing country. The certification requirements should not include conditions for diseases that are not transmitted by the commodity concerned. The certificate should be signed in accordance with the provisions of Chapter 5.2. 18/Item13

CC IV-4 International certification Terrestrial Code reference - Chapter 5.2: Certification procedures Article 5.2.1: Protection of the professional integrity of the certifying veterinarian Certification should be based on the highest possible ethical standards, the most important of which is that the professional integrity of the certifying veterinarian should be respected It is essential to include in any requirements only those specific statements that can be accurately and honestly signed by a certifying veterinarian Article 5.2.2: Certifying veterinarians… should: be authorised by the Veterinary Authority of the exporting country to sign international veterinary certificates; only certify matters that are within their own knowledge at the time of signing the certificate, or that have been separately attested by another competent party; only sign at the appropriate time certificates that have been completed fully and correctly; and have no conflict of interest in the commercial aspects of the animals or animal products being certified and be independent from the commercial parties. 19/Item13

CC IV-4 International certification Terrestrial Code reference - Chapter 5.2: Certification procedures Article 5.2.3: Preparation of international veterinary certificate Certificates should be drawn up in accordance with the following principles: minimize the potential for fraud text is simple, unambiguous and as easy to understand as possible, written in the language of the importing country and should not be amended appropriate identification of animals and animal products signature and stamp (embossed or in different colour) replacement certificates may be issued only original certificates are acceptable. Article 5.2.4: Electronic certification 20/Item13

CC IV-4 International certification Key issues to assess during PVS evaluations Who signs what ? Frozen fish, UHT milk, live poultry, hides and skins, wildlife, fresh shrimp ? Documented evidence of certificates issued (products, farm animals, companion animals) Documented evidence of certification of processes or services (e.g. deboning of meat and removal of SRMs for BSE) 21/Item13

IV-4 International certification The authority and capability of the VS to certify animals, animal products, services and processes under their mandate, in accordance with the national legislation and regulations, and international standards. Levels of advancement 1. The VS have neither the authority nor the capability to certify animals, animal products, services or processes. 2. The VS have the authority to certify certain animals, animal products, services and processes, but are not always in compliance with the national legislation and regulations and international standards. 3. The VS develop and carry out certification programmes for certain animals, animal products, services and processes under their mandate in compliance with international standards. 4. The VS develop and carry out all relevant certification programmes for any animals, animal products, services and processes under their mandate in compliance with international standards. 5. The VS carry out audits of their certification programmes, in order to maintain national and international confidence in their system. 22/Item13

CC IV-5 Equivalence, other sanitary agreements Glossary of terms Equivalence of sanitary measures means the state wherein the sanitary measure(s) proposed by the exporting country as an alternative to those of the importing country, achieve(s) the same level of protection Example: the double separatory funnel method is equivalent to the digestion and detection method to demonstrate absence of trichinellosis in meat 23/Item13

CC IV-5 Equivalence, other sanitary agreements Art.4. Sanitary and Phyto-Sanitary Agreement (SPS) Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection. 24/Item13

CC IV-5 Equivalence, other sanitary agreements formal agreement on sanitary measure(s) agreed between the exporting country and the importing country, with regard to an animal species or product. Example (bilateral): template international sanitary certificate for the trade of fresh, chilled or frozen pork (pig-meat) between Vietnam and Thailand, with requirements for classical swine fever, Aujeszky and foot-and-mouth disease. Example (multilateral): farm level milk sampling programme to verify somatic cell count (SCC) and standard plate count (SPC) in respect of EU regulation No. 853/2004. 25/Item13

IV-5 Equivalence and other types of sanitary agreements The authority and capability of the VS to negotiate, implement and maintain equivalence and other types of sanitary agreements with trading partners. Levels of advancement 1. The VS have neither the authority nor the capability to negotiate or approve equivalence or other types of sanitary agreements with other countries. 2. The VS have the authority to negotiate and approve equivalence and other types of sanitary agreements with trading partners, but no such agreements have been implemented. 3. The VS have implemented equivalence and other types of sanitary agreements with trading partners on selected animals, animal products and processes. 4. The VS actively pursue the development, implementation and maintenance of equivalence and other types of sanitary agreements with trading partners on all matters relevant to animals, animal products and processes under their mandate. 5. The VS actively work with stakeholders and take account of developments in international standards, in pursuing equivalence and other types of sanitary agreements with trading partners. 26/Item13

CC IV-6 Transparency Glossary of terms Transparency means the comprehensive documentation of all data, information, assumptions, methods, results, discussion and conclusions used in the risk analysis. Conclusions should be supported by an objective and logical discussion and the document should be fully referenced. 27/Item13

CC IV-6 Transparency Terrestrial Code references Section 1. Animal disease diagnosis, surveillance and notification Article 3.1.2. Veterinary legislation It should define and document the responsibilities and structure of the organisations in charge of the animal identification system, control of animal movements, animal disease control and reporting systems, epidemiological surveillance and communication of epidemiological information. 28/Item13

CC IV-6 Transparency . Terrestrial Code reference - Article 3.2.8. Animal health status / National animal disease reporting systems should be able to provide further, detailed elaboration of any elements of its animal disease status as reported to the OIE. The presence of a functional animal disease reporting system which covers all agricultural regions of the country and all veterinary administrative control areas should be demonstrated. 29/Item13

CC IV-6 Transparency Terrestrial Code reference – Chapter 5.1. on General obligations related to certification The animal health situation in the exporting country, in the transit country or countries and in the importing country should be considered before determining the requirements for trade. Certification requirements should be exact and concise, and should clearly convey the wishes of the importing country. 30/Item13

2. The VS occasionally notify. IV-6 Transparency The authority and capability of the VS to notify the OIE of their sanitary status and other relevant matters (and to notify the WTO SPS Committee where applicable), in accordance with established procedures. Levels of advancement 1. The VS do not notify. 2. The VS occasionally notify. 3. The VS notify in compliance with the procedures established by these organisations. 4. The VS regularly inform stakeholders of changes in their regulations and decisions on the control of relevant diseases and of the country’s sanitary status, and of changes in the regulations and sanitary status of other countries. 5. The VS, in cooperation with their stakeholders, carry out audits of their transparency procedures. 31/Item13

CC IV-7 Zoning Glossary of terms zone means a clearly defined part of a territory containing an animal subpopulation with a distinct health status with respect to a specific disease for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade. 32/Item13

CC IV-7 Zoning Terrestrial Code reference - Chapter 4.3. on zoning and compartmentalisation zoning applies to an animal subpopulation defined primarily on a geographical basis. The extent of a zone and its geographical limits should be established by the Veterinary Authority on the basis of natural, artificial and/or legal boundaries, and made public through official channels. A protection zone may be established to preserve the health status of animals in a free country or zone. In the event of limited outbreaks in a country or zone previously free of a disease, a containment zone may be established for the purposes of trade. 33/Item13

free zone Zones infected zone infected zone main road Protection Zone railroad river infected zone 34/Item13

free zone Zones infected zone infected zone main road Protection Zone Containment Zone Protection Zone railroad river infected zone 35/Item13

1. The VS cannot establish disease free zones. IV-7 Zoning The authority and capability of the VS to establish and maintain disease free zones, as necessary and in accordance with the criteria established by the OIE (and by the WTO SPS Agreement where applicable). Levels of advancement 1. The VS cannot establish disease free zones. 2. As necessary, the VS can identify animal subpopulations with distinct health status suitable for zoning. 3. The VS have implemented biosecurity measures that enable it to establish and maintain disease free zones for selected animals and animal products, as necessary. 4. The VS collaborate with their stakeholders to define responsibilities and execute actions that enable it to establish and maintain disease free zones for selected animals and animal products, as necessary. 5. The VS can demonstrate the scientific basis for any disease free zones and can gain recognition by trading partners that they meet the criteria established by the OIE (and by the WTO SPS Agreement where applicable). 36/Item13

CC IV-8 Compartmentalisation Glossary of terms Compartment means an animal subpopulation contained in one or more establishments under a common biosecurity management system with a distinct health status with respect to a specific disease or specific diseases for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade. 37/Item13

CC IV-8 Compartmentalisation Terrestrial Code reference - Chapter 4.4 Application of compartmentalisation Compartmentalisation applies to an animal subpopulation defined primarily by management and husbandry practices relating to biosecurity. A compartment should be clearly defined indicating the location of all its related functional units (such as feed mills, slaughterhouses, rendering plants, etc.); their interrelationships and their contribution to an epidemiological separation between the animals in a compartment and subpopulations with a different health status. The definition of compartment may revolve around disease specific epidemiological factors, animal production systems, biosecurity practices infrastructural factors and surveillance. 38/Item13

Compartment Equipment BREEDING FLOCK FEED SUPPLY Feed Equipment Birds Feed Feed Equipment GROWING FLOCK Equipment Birds Birds Equipment Birds SLAUGHTER HOUSE GROWING FLOCK Equipment 39/Item13

IV.8 Compartmentalisation The authority and capability of the VS to establish and maintain disease free compartments as necessary and in accordance with the criteria established by the OIE (and by the WTO SPS Agreement where applicable). Levels of advancement 1. The VS cannot establish disease free compartments. 2. As necessary, the VS can identify animal subpopulations with a distinct health status suitable for compartmentalisation. 3. The VS have implemented biosecurity measures that enable it to establish and maintain disease free compartments for selected animals and animal products, as necessary. 4. The VS collaborate with their stakeholders to define responsibilities and execute actions that enable it to establish and maintain disease free compartments for selected animals and animal products, as necessary. 5. The VS can demonstrate the scientific basis for any disease free compartments and can gain recognition by other countries that they meet the criteria established by the OIE (and by the WTO SPS Agreement where applicable). 40/Item13

Organisation Mondiale de la Santé Animale World Organisation for Animal Health Organización Mundial de Sanidad Animal 41/Item13