1. World Organisation for Animal Health

2. Import risk analysis WTO Regional Workshop on the SPS Agreement
David Wilson
Head, International Trade
OIE

3. Topics for discussion risk and risk analysis making decisions
using the OIE Codes
components of import risk analysis (IRA)
hazard identification
risk assessment
risk management
risk communication

4. Risk and risk analysis

5. What is risk?
the likelihood or chance of meeting some form of harm, loss or damage
risk has two components
the likelihood or probability of an event occurring
the likely consequences and their magnitude or seriousness
note differences from common use of ‘risk’
it is not looking at ‘possibilities’

6. What is risk analysis? a structured process designed to determine:
what can go wrong ?
how likely is it to go wrong ?
what would the consequences be ?
what can be done to reduce the likelihood and/or the consequences ?
risk analysis is part of our daily lives – it is not rocket science
it is a way of addressing uncertainty

7. Import risk analysis (IRA)
IRA is a specialised use of risk analysis
purpose: to assess pest / disease risks associated with imports objectively and transparently so that
the transfer of pathogens is avoided
import measures can be scientifically justified
trade restrictions are minimised
a good IRA is important to both importing and exporting countries

8. Skills required skills more important than structures
because a range of different skills required, a multi-disciplinary project team approach usually best
risk analyst
epidemiologist, virologist, parasitologist
environmental scientist, industry technologist
economist

9. Making decisions

10. Decision-making context
domestic responsibilities
biosecurity / quarantine legislation
government policies
international responsibilities
WTO SPS Agreement
OIE Codes
principles
scientific objectivity
transparency
consistency
no such thing as ‘zero risk’

11. Identifying the problem
commodity
what is the traded commodity?
what commercial methods of production / processing are normally applied?
fresh meat eg pork? processed meat eg Parma ham?
source(s)
single country or part of a country?
many or all countries?
use(s) in importing country?
volume of trade (if possible)

12. Deciding import measures
do an import risk analysis
use measures described in the OIE Codes
combine the two
using decision-making principles above

13. Other important factors
evaluation of Veterinary Services
concepts of zoning / compartmentalisation
surveillance and monitoring for animal health
ethics of veterinary certification

14. When to do an IRA when there is no international standard
when the international standard is unsatisfactory
when risks are not clearly understood to be either acceptable or unacceptable at the start
when assumptions are challenged
when new information becomes available

15. When not to do an IRA when no hazard can be identified
when there is a satisfactory international standard
when there is broad agreement concerning the likely risks
when the commodity per se meets the required level of protection of the importing country

16. Using the OIE Codes
determine animal health status of exporting country using OIE information
list diseases of concern (hazards)
consult relevant Code chapters re ‘safe’ and ‘unsafe’ commodities
draw up import health measures according to relevant Code chapters

17. Commodities ‘safe’ commodities ‘unsafe’ commodities
when authorising import or transit of the following commodities, Veterinary Administrations should not require any XXX related conditions, regardless of the XXX status of the exporting country/zone:
‘unsafe’ commodities
when authorising import or transit of the following commodities, Veterinary Administrations should require the conditions prescribed in this Chapter relevant to the XXX status of the exporting country/zone:

18. Safe commodities ‘safe’ commodities for FMD ‘safe’ commodities for BSE
bovine embryos
‘safe’ commodities for BSE
bovine semen
milk
‘safe’ commodities for AI ??

19. 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 …

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 the day of shipment;
were kept in an NAI free country or zone/compartment since they were hatched or for the past 21 days;
either have not been vaccinated against NAI, or have been vaccinated (and the details provided)

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 or zone/compartment free from HPNAI infection, … should require for fresh meat and meat products of poultry (other than turkey) 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 clinical sign 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 not known to be free from HPNAI, … should require for fresh meat and meat products of poultry and poultry viscera (other than turkey) the presentation of an IVC attesting that the consignment comes from birds:
which have been kept in a free establishment;
which have been tested … with negative results;
which have been slaughtered in an approved abattoir which has not processed poultry infected with NAI since last cleaned and disinfected, and have been subjected to AM and PM inspections for NAI

24. Code measures for AI
when importing from a country or zone/compartment not known to be free from NAI, … should require for meat products and processed viscera 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 …

25. AI information sources
OIE FAO WHO Web pages
early warning notices of disease outbreaks
Weekly Disease Information
OIE Bulletin
World Animal Health
general information on animal diseases and zoonoses
OIE Scientific and Technical Review

27. AI information needs AI notifiable ? official surveillance programme ?
administration knowledge of real situation ?
farmer awareness programme in place ?
official surveillance programme ?
existence of AI-free zones or zones of low prevalence ?
strains present and their virulence
official control programme in place ?
additional information from other sources ?

28. Import risk analysis

29. Context

30. Principles both qualitative and quantitative approaches valid
appropriate in different circumstances
reasoned and logical discussion
consistent methodology
comprehensive documentation
information used
assumptions and uncertainties
peer review

31. Approaches qualitative approach quantitative approach narrative form
outputs expressed in qualitative terms – high, medium, low, negligible
quantitative approach
outputs expressed numerically as point value or range of values
not necessarily more precise, depending on data

32. A risk analysis must
identify the hazards whose entry, establishment or spread a Member wants to prevent
evaluate the likelihood of entry, establishment or spread of these hazards, and the potential biological and economic consequences
evaluate the likelihood of entry, establishment or spread of these hazards according to the SPS measures that might be applied to reduce the risks to an acceptable level

33. Hazard Identification
4 components of IRA
based on Terrestrial Code guidelines
Hazard Identification
Risk Assessment
Risk Management
Risk Communication

34. Hazard Identification
Risk communication
Hazard Identification
Risk Assessment
Risk Management
Risk Communication

35. Risk communication
during an IRA, an exchange amongst interested parties of
information and opinions regarding hazards and risks
assumptions, results and conclusions of the risk analysis
proposed measures
transparent and interactive

36. Risk communication
establish a risk communication strategy at the start of each risk analysis
continue throughout the analysis
identify interested parties / stakeholders
determine how best to communicate
public meetings
technical experts
circulation of papers
Web page

37. Risk communication what can go wrong?
scientific uncertainty exaggerated by opponents
risks talked down by proponents
public’s lack of scientific background
fixed opinions
bad media coverage
lack of trust in government

38. Hazard identification
Risk Assessment
Risk Management
Risk Communication

39. Hazard identification
hazard: something which could produce adverse biological, environmental or economic consequences following the importation of a commodity
for our purposes, this step identifies pathogens, toxins etc
IRA must address risk on a hazard-specific basis – can’t just combine hazards
but probably some overlap

40. Hazard identification
to classify a pathogen or toxin as a hazard
it should be relevant to the animal or commodity to be imported
it could produce adverse consequences in the importing country
its presence in the exporting country cannot be ruled out
it should not be present in the importing country or, if present, it should be subject to control or eradication measures

41. Hazard identification
a risk analysis may be concluded here
if no potential hazard is identified or
if measures recommended in the OIE Code are able to be applied to each identified hazard

42. Avian influenza definition:
notifiable avian influenza (NAI) is defined as an infection of poultry caused by any influenza A virus of the H5 or H7 subtypes or by any AI virus with an intravenous pathogenicity index (IVPI) greater than 1.2 (or as an alternative at least 75% mortality) …
highly pathogenic notifiable avian influenza (HPNAI)
low pathogenicity notifiable avian influenza (LPNAI)

43. Avian influenza
HPNAI viruses have an IVPI in 6-week-old chickens greater than 1.2 or cause at least 75% mortality in 4-to 8-week-old chickens infected intravenously ...
LPNAI are all influenza A viruses of H5 and H7 subtype that are not HPNAI viruses

44. Hazard Identification
Risk assessment
Hazard Identification
Risk Assessment
Risk Management
Risk Communication

45. Risk assessment risk assessment has 4 components release assessment
exposure assessment
consequence assessment
risk estimation

46. Release assessment
this step assesses the likelihood that a hazard is able to be released into an importing country

47. Release assessment two procedures OIE Code lists relevant factors in
description of scenarios / biological pathways
evaluation of likelihoods
OIE Code lists relevant factors in
describing the steps in a release scenario
assigning likelihoods to the steps
biological factors
country factors
commodity factors

48. Exporting country biological factors
susceptibility of species / breed of animal
agent predilection sites
means of transmission
impact of vaccination, testing, treatment

49. AI biological factors species / breed
poultry: ‘all birds reared or kept in captivity for production of meat / eggs for consumption, for production of other commercial products, for restocking supplies of game, or for breeding these categories of birds’
aquatic birds as main reservoirs of viruses of low virulence for poultry - may become virulent after passage in poultry hosts
able to infect humans

50. AI biological factors agent predilection sites
live poultry and live birds other than poultry
hatching eggs / eggs for consumption
egg products
fresh meat / meat products / viscera
semen
feathers / down

51. AI biological factors means of transmission
respiratory secretions and faeces
carcasses
contaminated poultry equipment
people handling infected birds
impact of vaccination, testing, treatment
tests for differentiating infected from vaccinated birds (DIVA)
use of vaccination in breeding flocks

52. AI country factors incidence / prevalence of disease
pest / disease free areas

53. 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 …

54. AI information needs AI notifiable ? official surveillance programme ?
administration knowledge of real situation ?
farmer awareness programme in place ?
official surveillance programme ?
existence of AI-free zones or zones of low prevalence ?
strains present and their virulence
official control programme in place ?
additional information from other sources ?

55. AI country factors evaluation of veterinary services
guidelines for evaluation of Veterinary Services - Terrestrial Code

56. AI country factors farming practices - compartments ?
highly integrated housed commercial flocks
free-range flocks
village chickens
presence of populations of wild birds

57. AI commodity factors what is the traded commodity ?
effect of processing / production methods
raw eggs
frozen carcasses
cooked meat (internal temperature of 70°C)
post-processing contamination

58. release scenario

59. release scenario Herd of origin of meat not infected infected P1
Animal of origin of meat
infected P2
AM/PM inspection
infection detected and animal rejected
infection not detected P3
Meat prepared and stored
pathogen inactivated
pathogen not inactivated P4
Infected meat arrives in importing country
release scenario

60. Release assessment
in the second phase, a likelihood is applied to each scenario step
results in an estimate of the likelihood that the complete chain of events will occur
eg the likelihood that imported live birds or meat will be infected on arrival
a risk analysis may be concluded here
if the likelihood of introducing the hazard in the commodity is negligible

61. Exposure assessment
this step assesses the likelihood that animals and/or humans will be exposed to the hazard in the importing country
examine importing country factors

62. Exposure assessment
describes the biological pathway(s) necessary for animals and/or humans to be exposed – exposure scenarios
estimates the likelihood of these exposure(s) occurring
OIE Code lists relevant biological, country and commodity factors in
describing the steps in an exposure scenario
assigning likelihoods to the component steps

63. Importing country biological factors
infectivity / virulence of pathogen / toxin
susceptibility of exposed animals / humans
outcomes of infection

64. Infectivity / virulence
infectivity / virulence of pathogen / toxin
LPNAI or HPNAI

65. Exposure susceptibility
susceptibility of exposed animals / humans
poultry / other domesticated birds / wild birds
vaccinated or recently infected with same strain ?
likelihood of genetic recombination into new strain  new susceptibilities

66. Country factors presence of vectors human / animal demographics
wild waterfowl
human / animal demographics
mixing of human/pig/bird populations
environment
farming practices
free-range operations – bird/pig
non-integrated enterprises – small holdings
cultural practices
wet markets
free-range animals

67. commodity factors volume of trade intended use
risk increases with volume
intended use
unprocessed product
human food
waste disposal practices
scraps to pigs, backyard birds
unprotected garbage tips

68. exposure scenarios Infected meat arrives in importing country P6 P5
% meat sold in cities/towns
% meat sold in rural areas P9
P14 P7 P8
P15
Uncooked scraps not discarded
Uncooked scraps discarded – backyard pigs exposed
Uncooked scraps discarded – commercial pigs exposed
Uncooked scraps discarded – wild pigs exposed

69. Exposure assessment
in the second phase, a likelihood is applied to each scenario step
results in an estimate of the likelihood of the exposure pathways occurring
a risk analysis may be concluded here
if the likelihood of every exposure pathway is negligible

70. Consequence assessment
this step assesses the likelihood of the hazard establishing and spreading
then estimates the biological, environmental and economic consequences
this may be difficult in a country in which the hazard has never been present
must be causal link between exposure and consequences

71. Consequence assessment
potential consequences may be ‘direct’ or ‘indirect’
consequences not related to a hazard, eg the impact of competition from cheaper imported goods, cannot be considered

72. Direct consequences on domestic birds on public health environmental
morbidity and mortality
production losses
pet, backyard and commercial birds
on public health
environmental
physical environment eg ‘side effects’ of control measures
on biodiversity, endangered native species

73. Indirect consequences
economic
control / eradication costs; compensation programs
surveillance / monitoring costs
domestic effects (changes in consumer demand, effects on related industries)
trade losses (sanctions, lost markets, additional costs to meet existing markets)
environmental
reduced tourism
loss of social amenity

74. Estimating consequences
direct and indirect consequences may be estimated at four levels
farm/village, district, regional and national
at each level, magnitude of impact needs to be described
insignificant
minor significance
significant, or
severe

75. Consequence assessment
a small number of ‘outbreak scenarios’ may help evaluation of
likely magnitude of the consequences, and
the likelihood that they will occur at any given magnitude

76. outbreak scenarios

77. outbreak scenarios commercial pigs exposed wild pigs exposed
Uncooked scraps not discarded
backyard pigs exposed
P10
P12
P16
P13
P11
No outbreak
No outbreak
P17
Disease outbreak in commercial pigs
Disease outbreak in wild pigs
Disease outbreak in backyard pigs
P20
P23
P18
P19
P21
P24
P25
P26
large
large
small
P22
medium
small
small
medium
medium
large

78. Outbreak scenario likely outcomes
disease does not establish within the exposed population
disease establishes within the exposed population, but is quickly identified and eradicated
disease establishes within the exposed population and spreads to other (animal and human) populations before being eradicated
disease establishes within the exposed population, spreads to other populations and becomes endemic

79. Consequence assessment
a risk analysis may be concluded here
if no significant consequences are identified, or
the likelihood of every identified consequence (other than ‘insignificant’) is negligible

80. Risk estimation combination of likelihoods and consequences
 ‘unrestricted risk estimate’

81. Risk estimation combines the results from each to estimate
release and exposure assessment
consequence assessment
to estimate
the likelihood of each hazard entering, establishing and spreading, and
the likely adverse consequences
can’t just conclude ‘possibility of entry’ or ‘potential consequences’

82. Hazard Identification
Risk management
Hazard Identification
Risk Assessment
Risk Management
Risk Communication

83. Risk management
process of identifying, selecting and implementing health measures to reduce the level of risk to an ‘acceptable’ level
ie meet the importing country’s appropriate level of protection (ALOP)
while minimising negative effects on trade
often most difficult step
due to interaction of science and policy

84. ALOP ‘acceptable risk’ value based policy decision of government
what level of risk is acceptable to community ?
determines how ‘risk adverse’ its approach is
does not have to be based on science
social / cultural factors may be included
must be applied consistently
usually applied through comparison with previous decisions and existing regulations

85. Components of RM risk evaluation option evaluation
comparing the ‘unrestricted risk estimate’ with the importing country’s ALOP
option evaluation
identifying possible measures, including OIE Code recommendations, to be applied
re-evaluating the likelihoods of release, exposure, establishment and spread according to the measure(s) applied
selecting the option which best meets the ALOP

86. Components of RM implementation monitoring and review
outcomes of risk assessment are aids to decision-making
needs to be definite link between outcomes of risk assessment and measures applied
monitoring and review
a continuous process

87. Hazard Identification
Components of IRA
Hazard Identification
Risk Assessment
Risk Management
Risk Communication

88. World organisation for animal health
Thank you for your attention
World organisation for animal health
12 rue de Prony
75017 Paris, France
Tel: 33 (0)
Fax: 33 (0)