ira singapore dec 2004 dw

World Organisation for Animal Health

Import risk analysis

David Wilson

Head, International Trade OIE

WTO Regional Workshop on the SPS Agreement

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

 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

 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 ?

 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

REPORT RISK

ASSESSM ENT Release assessm ent

Consequence assessment Risk estimation

Exposure assessm ent

RISK M ANAGEM ENT

Risk evaluation

Implem entation M onitoring and review

Option evaluation EVALUATIO N O F

Veterinary Services

Surveillance and monitoring of anim al health

Zoning and regionalisation

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

 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

4 components of IRA



based on Terrestrial Code guidelines

Hazard Identification

Risk Assessment

Risk

Management

Risk Communication

34

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

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

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

 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 ?

 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

Meat processed

birds slaughtered

Meat stored

Arrival of infected meat in importing country

Selection of source

flocks L1=Prob.(infected flock selected)

L3=Prob.(pathogenic agent survives processing) L2=Prob.(infected birds selected)

L4=Prob.(pathogenic agent survives storage) Selected flocks

not infected

Selected flocks infected

Slaughtered birds) infected

Slaughtered birds not infected

Pathogenic agent not inactivated during processing

Pathogenic agent inactivated during processing

Pathogenic agent not inactivated during

storage

Pathogenic agent inactivated during

storage

59

release scenario

Herd of origin of meat

not infected infected P1

Animal of origin of meat

infected P2

not infected 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

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

 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

 risk increases with volume



intended use

 unprocessed product

 human food



waste disposal practices

 scraps to pigs, backyard birds

 unprotected garbage tips

exposure

scenarios

Infected meat arrives in importing country

% meat sold in rural areas

% meat sold in cities/towns

Uncooked scraps not discarded Uncooked

scraps discarded – commercial pigs exposed

Uncooked scraps discarded – wild pigs exposed

Uncooked scraps discarded – backyard pigs exposed

P5 P6

P7 P8

P9 P14

P15

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

 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

Exporting country

Importing country

First exposed

group

Second exposed

group

Likely consequences of establishment and spread

(second exposed group) No outbreak

Likely consequences of establishment and spread

(first exposed group)

Outbreak scenario

2 No

outbreak

Outbreak scenario

2

Outbreak scenario

1 Outbreak

scenario 1

Release assessment

Consequence assessment

Impact on each direct and

indirect consequence

criterion

Exposure assessment

PLES2 PLES1

Impact on each direct and

indirect consequence

criterion PLES2

Impact on each direct and

indirect consequence

criterion Impact on each

direct and indirect consequence

criterion

PLES2

PLES1 PLES2

PLE1 PLE2

outbreak

scenarios

outbreak scenarios

P11

Disease outbreak in commercial pigs

Disease outbreak in wild pigs

Disease outbreak in backyard pigs

small small

medium

P12

P13 P17

small medium

large large

large

medium

P26 P25

P24 P23

P22 P21

P20 P18 P19

Uncooked scraps not discarded commercial

pigs exposed wild pigs

exposed

backyard pigs exposed

No outbreak No outbreak

P10 P16

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

 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

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

 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

 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

Components of IRA

Hazard Identification

Risk Assessment

Risk

Management

Risk Communication

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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

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