1. The OIE’s Codes and Manuals
David Wilson
Director International Trade
OIE
The OIE’s Codes and Manuals
Comments (with copyright) / Commentaires (soumis au Copyright) :
OIE SPS Workshop Bangkok 2005

2. Topics for discussion Codes Manuals updating OIE standards
AI and BSE as examples
Manuals
updating OIE standards
new standards adopted in 2005

3. OIE’s international standards

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
Terrestrial Animal Health Code
Aquatic Animal Health Standards Commission
Aquatic Animal Health Code
Manual of Diagnostic Tests for Aquatic Animals
Biological Standards Commissions
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
recommends 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 of disease or with a control programme

11. What information is available from Codes and Manuals ?
Criteria for disease freedom
Guidelines for risk analysis
Conditions for trade
Risk mitigation to render products safe
Surveillance for disease
Guidelines for carcass disposal
Standards for diagnostic tests
Foot & mouth disease
Standards for vaccine production
Model export certificates
Guidelines for humane killing of animals
Standards for zoning & 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
birds
bees

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
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
regardless of the NAI status of the country of origin, Veterinary Administrations should require, for live birds other than poultry, an IVC attesting that the birds:
showed no clinical sign of NAI on the day of shipment;
were kept in isolation approved by the Veterinary Services since they were hatched or for the 21 days prior to shipment and showed no clinical sign of NAI during the isolation period;
were subjected to a diagnostic test 7 to 14 days prior to shipment to demonstrate freedom from NAI.

22. 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

23. 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 …

24. BSE as an example

25. 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 cattle pop
surveillance and other epidemiological investigations
exposure assessment if the release assessment identifies a risk factor

26. 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

27. Code - BSE status negligible BSE risk controlled BSE risk
undetermined BSE risk

28. 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

29. 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"

30. Aquatic Animal Health Code

31. 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

32. 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

33. 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 risk-based measures for commodities
importance of disease surveillance and timely notification
interactive publications

34. OIE Manuals

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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

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

42. 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

43. Using the Codes and Manuals

44. Using the Codes and Manuals
use the Codes to establish health requirements for trade
use the OIE Scientific and Technical Review and other sources to obtain background information
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

45. Summary: Critical aspects in using the Codes and Manuals
do not use the Codes as a textbook on diseases
use it as an international standard to evaluate measures to protect animal and aquatic 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

46. 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 importing countries

47. Updating OIE standards

48. 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 new or revised standard
using working groups and ad hoc groups for specialist tasks eg animal welfare, BSE, epidemiology, avian influenza, TB

49. Updating OIE standards
COMMITTEE, COMMISSIONS, DELEGATES
PROBLEM
Specialist
Commissions
Updating OIE standards
Review
Advice of experts or other Specialist Commissions
Draft text 1 2
Comments
DELEGATES
COMMITTEE
OIE INTERNATIONAL STANDARD
Adoption

50. 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 on OIE Web site

51. 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

52. New standards adopted in 2005

53. Revised terrestrial texts
zoning and compartmentalisation
criteria for listing diseases
general guidelines for animal health surveillance
FMD and its surveillance appendix
bluetongue
bovine tuberculosis
classical swine fever
avian influenza
Rift Valley fever
bovine and small ruminant semen
antimicrobial resistance

54. New terrestrial texts BSE (3 category approach)
BSE surveillance (new approach)
classical swine fever surveillance
avian influenza surveillance
4 animal welfare standards

55. New and revised aquatic texts
notification criteria and epidemiological information
infection with Marteilia refringens
white spot disease
epizootic haematopoietic necrosis
general recommendations on disinfection

56. World organisation for animal health
12 rue de Prony
75017 Paris, France
Tel: 33 (0)
Fax: 33 (0)