1. Seminar on the Dialogue and Common activities
DG SANCO - DG ENLARGEMENT - TAIEX
Seminar on the Dialogue and Common activities
between OIE Member Countries of the European
Union and other Member Countries of the OIE
Regional Commission for Europe
Serbia, Belgrade, 4-5 May 2006

2. The Codes and Manuals of the OIE
Dr Gideon Brückner
Head of the Scientific and Technical Department
and
Dr Francesco Berlingieri
Deputy Head of the International Trade Departmant
The Codes and Manuals of the OIE
Comments (with copyright) / Commentaires (soumis au Copyright) :

3. Topics for discussion Codes and Manuals AI and BSE as examples
Updating OIE standards
New standards adopted in 2005

4. The international standards of the OIE

5. 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

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

7. 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

8. 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

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 (Terrestrial Code)

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. The linkage between OIE Codes and Manuals and the SPS Agreement
International standard setting organizations
Article 3 talks about harmonization of measures. It recognizes that while each country can take its own measures, they are encouraged to take the standards from international organizations into consideration. This is more likely to result in harmonized approaches.
These three are the only three standard-setting organizations recognized by the SPS, OIE for the purpose of animal health and zoonoses (diseases transmitted from animals to man); the Codex Alimentarius for purposes of public health and food safety; and the IPPC for plant health.
Codes and Manuals must be used in context with Codex and SPS Agreement

12. Linkage of Codes, Manuals & SPS Agreement with national legislation and sanitary measures

13. 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

14. Summary: relationship between OIE Codes & SPS Agreement
ALOP determined by the importing country
Appropriate level of protection (ALOP)
OIE Codes and Manuals
Risk Analysis
SPS Agreement
OIE Code used as international standard for negotiations
Exporting country’s legislation must facilitate ALOP & withstand risk analysis
SPS Agreement determines “rules of the game”
Trade negotiations – How??
Risk analysis done by importing country to match ALOP

15. Terrestrial Animal Health Code

16. 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

17. 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

18. Aim of OIE Codes and Manuals
Terrestrial Animal Health Code: To assure the sanitary safety of the international trade in terrestrial animals (mammals, birds and bees).
Aquatic Animal Health Code: To assure the sanitary safety of international trade in aquatic animals (fish, molluscs and crustaceans) and their products.
Diagnostic Manuals: To provide standards for diagnostic tests and vaccines for the diseases listed in the OIE Terrestrial Animal Health Code and the Aquatic Animal Health Code

19. What is the purpose of the Codes?
The Codes are not intended to be textbooks on animal or aquatic diseases
The Codes are not textbooks on zoonosis
The primary object is to set recommendations. standards and guidelines to PROTECT ANIMAL HEALTH and guard against zoonotic diseases in the trade of terrestrial and aquatic animals and their products
The Codes are thus a reference manual for the international standards, guidelines and recommendations for the trade in terrestrial and aquatic animals and their products as specified in the SPS Agreement
The standards for the trade in animal products to protect HUMAN HEALTH is described in the Codex Alimentarius but should be read in conjunction with the relevant requirements in the Codes

20. Approach in the Codes for the description of diseases
Definitions: tend to overlook – also international standard and reference
Ethics on certification – value judgment for both importing and exporting countries
Appendices – give more detailed description – surveillance, disinfection, collection of samples, inactivation of pathogens, risk mitigation
Model health certificates – based on contents of applicable chapters and minimum requirements
Diseases:
Science-based approach
Incubation period – determining quarantine period and other risk mitigation procedures
Criteria for recognizing a country, zone or establishment free from disease/infection – with or without vaccination (FMD)
Movement and risk mitigation recommendations between countries/zones/establishments of different status
Importing and exporting risk mitigation procedures for animals and animal products

21. Key principle for the international trade in animals and animal products
The acceptance of the sanitary guarantees of the exporting country and how closely it satisfies the desired level of protection for human and animal health of the importing country

22. The Codes give guidelines and recommendations for ANIMAL HEALTH PROTECTION for both importing and exporting countries
The outcome of trade negotiations, is of equal importance to both the importing and exporting country
IMPORTING COUNTRY: To ensure that the imported commodity do not endanger the required level of protection for human and animal health
EXPORTING COUNTRY: To focus on the shortcomings indicated by the IRA or negotiations and the ability to render the sanitary guarantees required by the importing country

23. What information will I need to negotiate trade and will I find it in the Codes and Manuals of the OIE?
What sanitary guarantees could the importing country require?
What risk mitigating measures would I be required to put in place?
What tests need to be conducted to verify disease-free claims?
What are the requirements to accept a disease free zone?
When and why is an import risk assessment necessary?
What will be an acceptable certification?
What products will be acceptable for export?
What products will not be acceptable for export and why not?
How do I know that the standard of veterinary service delivery is acceptable?
What are the alternatives if a country cannot declare a disease-free zone?
If the disease is present in my country can I still export products irrespective of the disease status?

24. 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

25. Using the Codes and Manuals

26. 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

27. 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

28. OIE Manuals

29. 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

30. 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

31. 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

32. Avian influenza as an example

33. Code - AI status NAI free establishment
NAI free country, zone or compartment
HPNAI free country, zone or compartment

34. 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

35. 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

36. 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 …

37. BSE as an example

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

39. 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

40. 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"

41. Aquatic Animal Health Code

42. 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

43. 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

44. Updating OIE standards

45. 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

46. 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

47. 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

48. Creating and updating of international standards
PROBLEM
COMMITTEE, COMMISSIONS, DELEGATES
Specialist
Commissions
Comments
Review
Creating and updating of international standards
Advice of experts or other Specialist Commissions
Draft text
DELEGATES 1
COMMITTEE 2
Adoption
OIE INTERNATIONAL STANDARD

49. New standards adopted in 2005

50. 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
antimicrobial resistance

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

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

53. World Organisation for Animal Health
12 rue de Prony
75017 Paris, France
Tel: 33 (0)
Fax: 33 (0)