The OIE's Codes and Manuals David Wilson OIE SPS Workshop by huanghengdong

VIEWS: 8 PAGES: 57

									             David Wilson


        The OIE’s
Codes and Manuals


        OIE SPS Workshop    1

              Vienna 2006
        Topics for discussion
 OIE Codes
     Terrestrial Animal Health Code
     AI and BSE as examples
     Aquatic Animal Health Code
   OIE Manuals
   using the Codes and Manuals
   updating OIE standards
   standards adopted in 2006


                                       2
OIE’s international standards




                                3
Why are standards necessary?
 international public good
 harmonise health and welfare aspects of
  international trade
   fewer disease outbreaks, better welfare
 encourage harmonisation of national legislation
  and control measures with international
  equivalents
   fewer unjustified restrictions on trade
 promote fairer trade
   benefits especially to developing countries


                                                    4
  OIE international standards
 OIE develops and publishes
   health standards for trade in animals and animal
    products
   biological standards for diagnostic tests and vaccines
 adopted by OIE Member Countries during
  General Session each May by consensus
   no other pathway for adoption




                                                         5
  OIE international standards
 to maximise harmonisation of the health aspects
  of international trade, Veterinary Administrations
  should base their health measures on OIE
  standards




                                                   6
    The OIE Codes and Manuals
   Terrestrial Animal Health
    Code
   Aquatic Animal Health
    Code
   Manual of Diagnostic
    Tests and Vaccines for
    Terrestrial Animals
   Manual of Diagnostic
    Tests for Aquatic
    Animals

                                7
 OIE Specialist Commissions
 Terrestrial Animal Health Standards Commission
  in consultation with the Scientific Commission for
  Animal Diseases where relevant
   Terrestrial Animal Health Code
 Aquatic Animal Health Standards Commission
   Aquatic Animal Health Code
   Manual of Diagnostic Tests for Aquatic Animals
 Biological Standards Commission
   Manual of Diagnostic Tests and Vaccines for Terrestrial
    Animals

                                                        8
       Purpose of the Codes ?
 the Codes are not textbooks on terrestrial or aquatic
  animal diseases, nor on zoonoses
 they are reference manuals for international
  standards for safe trade in terrestrial and aquatic
  animals and their products
 equivalent standards for the protection of human
  health are described in the Codex Alimentarius
   these should be read in conjunction with relevant
    requirements in the Codes




                                                        9
                      Codes
 recommend health measures to be used by
  veterinary authorities or other competent
  authorities
       to establish health regulations for the safe importation
        of animals and animal products
       while avoiding unjustified trade restrictions

   now expanding into animal welfare and food
    safety


                                                               10
       Principles in the Codes

 WTO obligations complied with
 scientific basis for recommendations
      assessment of risk factors
      evaluation of veterinary services / competent
       authorities
      zoning and compartmentalisation
      epidemiological surveillance

 credible health certification
 importing country assumed to be free or with a
  control programme for a specific disease
                                                       11
What information is available
 from Codes and Manuals ?
                                       Guidelines                    Criteria for
         Conditions                                                    disease
          for trade                     for risk
                                        analysis                      freedom

    Risk
                                                                           Surveillance for
 mitigation
                                                                               disease
 to render
 products
    safe                                                                      Guidelines for
                                                                                 carcass
 Standards                                                                      disposal
     for                        Foot & mouth
 diagnostic                     disease
    tests                                                                  Standards for
                                                                              vaccine
                                                                            production
Model export
 certificates         Guidelines for
                      humane killing        Standards for zoning &
                        of animals          compartementalisation
                                                                                              12
Terrestrial
Animal Health
Code




                13
Approach in the Terrestrial Code
  generic (horizontal) chapters
      general definitions
      obligations and ethics in international trade
      disease notification
      import risk analysis methodology
      evaluation of veterinary services
      import/export procedures




                                                       14
Approach in the Terrestrial Code
  specific chapters on diseases for
    live animals
    genetic material
    products of animal origin (meat, milk,
     hides / skins)
  covering diseases of
    mammals eg FMD, BSE
    birds eg AI
    bees eg foulbrood


                                              15
Approach in the Terrestrial Code
  in each chapter, articles on
      description of pathogen / disease
      determining status of a country, zone or compartment
      ‘safe’ commodities irrespective of status (if possible)
      recommendations for ‘unsafe’ commodities




                                                             16
Approach in the Terrestrial Code
 appendices
      collection and processing of semen
      collection and processing of embryos/ova
      disease surveillance - general and disease specific
      inactivation of pathogens and vectors
      animal welfare and food safety
      antimicrobial resistance
 model veterinary certificates for
    live animals
    products of animal origin

                                                             17
Avian influenza as an example




                                18
          Code - AI status
 NAI status of a country, zone or compartment
  can be determined …
   outcome of a risk assessment, identifying all
    potential factors for NAI occurrence and their historic
    perspective
   when NAI is notifiable in the whole country, an on-
    going NAI awareness programme is in place, and all
    notified suspect occurrences of NAI are subjected to
    … investigations;
   appropriate surveillance is in place to demonstrate
    the presence of infection …

                                                          19
          Code - AI status
 NAI free establishment
 NAI free country, zone or compartment
 HPNAI free country, zone or compartment




                                            20
      Code measures for AI
 when importing live poultry from an NAI free
  country or zone/compartment, Veterinary
  Administrations should require an international
  veterinary certificate attesting that the poultry:
    showed no clinical sign of NAI on day of shipment;
    were kept in an NAI free country, zone or
     compartment since hatched or for past 21 days;
    either have not been vaccinated against NAI, or have
     been vaccinated (and the details provided)
    required surveillance within past 21 days


                                                            21
     Code measures for AI
 when importing from a country, zone or
  compartment free from HPNAI infection, …
  should require for fresh meat of poultry, an IVC
  attesting that the consignment comes from birds:
   which have been kept in an establishment since they
    were hatched or for the past 21 days in which there
    has been no evidence of NAI in the past 21 days;
   which have been slaughtered in an approved abattoir
    and have been subjected to AM and PM inspections
    for NAI with favourable results


                                                          22
     Code measures for AI
 when importing from a country or
  zone/compartment regardless of its NAI status,
  … should require for meat products of poultry,
  an IVC attesting that:
   the commodity is derived from fresh meat, meat
    products and/or viscera which meet the requirements
    of Articles [dealing with those commodities]; or
   the commodity has been processed to ensure the
    destruction of the NAI virus, and the necessary
    precautions were taken after processing …


                                                          23
BSE as an example




                    24
     BSE status of a cattle pop
 the outcome of a risk assessment identifying all
  potential factors for BSE occurrence and their
  historic perspective:
  • release assessment - likelihood that a TSE agent has
    been introduced into the country
  • surveillance and other epidemiological investigations
  • exposure assessment if the release assessment
    identifies a risk factor




                                                        25
     BSE status of a cattle pop
 on-going awareness programme for vets,
  farmers
 compulsory notification and investigation of all
  cattle showing clinical signs consistent with BSE




                                                  26
      Article for “safe commodities”
 When authorising import or transit of the following
  commodities, Veterinary Administrations should not
  require any BSE related conditions, regardless of the
  BSE status of the exporting country:

   milk and milk products;
   semen and in vivo derived cattle embryos;
   hides and skins;
   gelatin and collagen prepared exclusively from hides and
    skins;
   protein-free tallow (max of insoluble impurities of 0.15%
    in weight) and derivatives;
   dicalcium phosphate (with no trace of protein and fat);
   deboned skeletal muscle meat (excluding mechanically
    separated meat)
   blood and blood by-products                               27
       For other Commodities
 When authorising import or transit of other
  commodities listed in this chapter, Veterinary
  Administrations should require the conditions
  prescribed in this Chapter relevant to the BSE
  risk status of the cattle population of the
  exporting country and zone....




                                                   28
        Code - BSE status
 negligible BSE risk
 controlled BSE risk
 undetermined BSE risk




                            29
         Code measures for BSE
 When importing from a country, zone or
  compartment posing a controlled BSE risk, …
  should require for cattle an IVC attesting that:
   • cattle are identified by a permanent identification
     system enabling them to be traced back to the dam
     and herd of origin, and are not BSE exposed cattle
   • in the case of a country, zone or compartment with an
     indigenous case, cattle selected for export were born
     after the date from which the feed ban had been
     effectively enforced



                                                         30
     Code measures for BSE
 When importing from a … posing a controlled
  BSE risk … should require for fresh meat and
  meat products from cattle (other than those
  listed as safe) an IVC attesting that:
  • AM and PM inspections on all cattle from which the
    fresh meat and meat products originate
  • special stunning requirements were carried out
  • the fresh meat and meat products do not contain
    "prohibited tissues"



                                                         31
Aquatic Animal
Health Code




                 32
                Aquatic Code

 recommends health measures to be used by
  competent authorities
       to establish health regulations for the safe importation
        of aquatic animals and their products
       while avoiding unjustified trade restrictions

   principles as per Terrestrial Code




                                                               33
 Approach in the Aquatic Code
 generic (horizontal) chapters
     obligations and ethics in international trade
     disease notification
     import risk analysis methodology
     import/export procedures
     disinfection
 specific chapters for diseases of
   finfish
   molluscs
   crustaceans
 model certificates
                                                      34
Evolution of OIE standards
 harmonisation between Terrestrial and Aquatic
  Codes
    and with Codex and IPPC standards to extent possible
 regular updating of chapters based on latest scientific
  information
 re-emphasis from disease status to
  likelihood-based measures for commodities
 importance of disease surveillance and timely
  notification
 interactive publications



                                                            35
OIE Manuals




              36
   OIE biological standards
 OIE harmonises diagnostic testing and vaccination
  procedures through use of
     standard methods – OIE Manuals
     Reference Laboratories / Collaborating Centres
     International Reference Sera
     quality assurance guidelines
 supports laboratories in Member Countries
   reliable results
 coordinated by BSC and AAHSC


                                                       37
             OIE Manuals
 describe internationally agreed laboratory
  methods for disease diagnosis
   to enable the requirements for health certification in
    connection with trade to be met
 Terrestrial Manual also covers the production
  and control of biological products eg vaccines
 tests in the Manuals should be performed
  according to the methods described in order to
  avoid differences in interpretation of results


                                                             38
        Terrestrial Manual
 provides general information for veterinary
  officials on each disease, with tests and
  vaccines
   introduction to the subjects
   should be regarded as background information rather
    than standards
 provides detailed techniques for laboratory
  technicians
   standards



                                                      39
      Introductory Chapters –
         Terrestrial Manual
 sampling methods
 good laboratory practices, quality control and
  quality assurance
 principles of validation of diagnostic assays
 tests for sterility and freedom from contamination
  of biological materials
 human safety in the veterinary laboratory
 principles of veterinary vaccine production


                                                   40
         Disease Chapters –
         Terrestrial Manual
 diagnostic tests for OIE listed diseases and
  other diseases of importance to trade
 diagnostic tests
   ‘prescribed’ – those required by the Code for
    international trade – printed in blue
      not every listed disease has a ‘prescribed’ test
   ‘alternative’ – suitable for import/export after bilateral
    agreement
      not same level of confidence
      can provide valuable information for the diagnosis of disease
       nationally or regionally or for evaluating the risks of any
       proposed trade in animals or animal products
                                                                   41
         Disease Chapters –
         Terrestrial Manual
 Part A - overview of the tests and vaccines
  available
 Part B - details of diagnostic test techniques
    intended for laboratory workers
 Part C - requirements for vaccines or diagnostic
  biologicals, where appropriate




                                                     42
      Introductory Chapters –
           Aquatic Manual
 sampling methods
 quality management in veterinary diagnostic
  laboratories
 principles of validation of diagnostic assays for
  aquatic animal diseases




                                                      43
         Disease Chapters –
           Aquatic Manual
 for listed diseases, clinical signs in fish are not
  pathognomonic and infections may be
  subclinical
    only dependable approach for diagnosis lies in the
     specific identification of the pathogen
 diagnostic methods are all direct
    due to the insufficient development of serological
     methodologies, detection of antibodies to fish
     pathogens has not been accepted for assessing the
     health status of fish populations for trade
 for mollusc and crustacean diseases diagnostic
  methods must be direct because these animals
  do not produce antibodies                               44
Using the Codes and Manuals




                              45
Using the Codes and Manuals
                use the OIE Scientific and
                 Technical Review and other
                 sources to obtain background
                 information
                use the Codes to establish
                 health requirements for trade
                use the OIE Manuals to
                 ensure the application of
                 correct diagnostic tests and
                 vaccines
                use textbooks on diseases to
                 understand the scientific
                 justification for OIE standards

                                              46
Summary: Critical aspects in using
    the Codes and Manuals
 do not use the Codes as a textbook on diseases
 use them as an international standard to
  evaluate and determine measures to protect
  animal health in the trade of animals and animal
  products
 ensure that the application of the standards of
  the Codes for national health measures are in
  accordance with obligations under the SPS
  Agreement



                                                 47
Critical aspects in using the Codes
            and Manuals
 use the Guidelines for the Evaluation of
  Veterinary Services as an essential baseline for
  risk assessment
 use the Codes to establish baseline arguments
  to establish equivalence for trade negotiations
 use the Codes to establish cost-effective risk
  mitigation measures for trade
 use the Codes and Manuals to challenge
  scientific unjustifiable sanitary measures of
  trading partners


                                                     48
Updating OIE standards




                         49
              Transparency
 need best scientific basis to gain widest support
 all documents of Specialist Commissions on OIE
  Website
    resulting in comments from many individuals, governmental orgs
     and NGOs
 considered very useful sources of information
 comments from Delegates receive greatest weight and
  all orgs encouraged to submit comments to Delegates
    Delegates encouraged to consult relevant stakeholders




                                                                  50
    Updating OIE standards
 issue / problem identified by Delegate, OIE
  Commission, industry, scientist, individual
   new scientific information eg from research or disease
    outbreak
   new disease - emerging
   new approaches eg vaccination
 addressed by appropriate Commission as a
  potential new or revised standard
   using working groups and ad hoc groups for specialist
    tasks eg animal welfare, BSE, epidemiology, avian
    influenza, TB
                                                         51
              COMMITTEE,
             COMMISSIONS,           PROBLEM
              DELEGATES

                                     Specialist
                                    Commissions



                                      Review
Updating
   OIE                      Advice of experts or other
standards                    Specialist Commissions

                                     Draft text
                                    1
                                            2
            Comments         DELEGATES

                                          COMMITTEE

                OIE INTERNATIONAL
                     STANDARD
                                          Adoption       52
    Updating OIE standards
 increasingly, expert advice is outside
  government and OIE utilises all sources
   individual / expert group from industry / academia /
    government
   other OIE Commission or Reference Lab
 transitional period for transparency
   NGOs with OIE agreement are consulted as per
    Member Countries eg IDF
   experts may participate in meetings
   Commission reports placed on OIE Web site

                                                           53
     Updating OIE standards
 Commission proposal circulated for comment to
  Member Countries, experts, organisations
    Commission may revise proposal on basis of
     comments received
 discussed by Delegates at General Session
    may be discussed only and returned to Commission
     for further work
    may be adopted as OIE international standard
 opportunity for all to be involved in standards
  development
 normally, a two-year cycle
                                                        54
Standards adopted in 2006




                            55
    Examples of revised texts

   zoning and compartmentalisation
   criteria for listing diseases
   animal health surveillance
   FMD
   classical swine fever
   avian influenza
   BSE
   4 animal welfare standards


                                      56
World organisation for animal health

           12 rue de Prony
        75017 Paris, France
      Tel: 33 (0)1 44 15 18 88
      Fax: 33 (0)1 42 67 09 87
         Email: oie@oie.int
          http://www.oie.int
                                       57

								
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