world organisation for animal health. import risk analysis david wilson head, international trade...

World Organisation for Animal Health

Import risk analysis

David WilsonHead, International Trade

OIE

WTO Regional Workshop on the SPS Agreement

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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

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Risk and risk analysis

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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’

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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

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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

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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

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Making decisions

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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’

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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)

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Deciding import measures

do an import risk analysis use measures described in the OIE Codes combine the two

using decision-making principles above

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Other important factors

evaluation of Veterinary Services concepts of zoning / compartmentalisation surveillance and monitoring for animal

health ethics of veterinary certification

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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

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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

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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

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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:

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Safe commodities

‘safe’ commodities for FMD bovine embryos

‘safe’ commodities for BSE bovine semen milk

‘safe’ commodities for AI ??

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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 …

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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)

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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.

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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

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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

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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 …

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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

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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 ?

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Import risk analysis

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Context

REPORT

RISKASSESSMENT

Release assessm ent

Consequence assessment

Risk estimation

Exposure assessment

RISKMANAGEMENT

Risk evaluation

Implem entation

Monitoring and review

Option evaluation

EVALUATION OF

Veterinary Services

Surveillance and monitoringof anim al health

Zoning and regionalisation

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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

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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

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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

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4 components of IRA

based on Terrestrial Code guidelines

Hazard Identification

Risk Assessment

Risk Management

Risk Communication

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Risk communication


Risk Assessment

Risk Management

Risk Communication

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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

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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

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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

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Hazard identification


Risk Assessment

Risk Management

Risk Communication

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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

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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

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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

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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)

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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

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Risk assessment


Risk Assessment

Risk Management

Risk Communication

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Risk assessment

risk assessment has 4 components release assessment exposure assessment consequence assessment risk estimation

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Release assessment

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

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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

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Exporting country

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

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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

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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

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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

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AI country factors

incidence / prevalence of disease pest / disease free areas

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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 …

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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 ?

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AI country factors

evaluation of veterinary services guidelines for evaluation of Veterinary

Services - Terrestrial Code

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AI country factors

farming practices - compartments ? highly integrated housed commercial flocks free-range flocks village chickens

presence of populations of wild birds

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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

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releasescenario

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

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releasescenario

Herd of origin of meat

not infected infected P1

Animal of origin of meat

infected P2

not infectedAM/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

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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

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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

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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

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Importing country

biological factors infectivity / virulence of pathogen / toxin susceptibility of exposed animals / humans outcomes of infection

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Infectivity / virulence

infectivity / virulence of pathogen / toxin LPNAI or HPNAI

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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

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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

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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

exposurescenarios

Infected meat arrives in importing country

% meat sold in rural areas

% meat sold in cities/towns

Uncooked scraps not discardedUncooked

scraps discarded – commercial pigs exposed

Uncooked scraps discarded – wild pigs exposed

Uncooked scraps discarded – backyard pigs exposed

P5 P6

P7 P8

P9P14

P15

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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

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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

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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

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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

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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

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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

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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

Releaseassessment

Consequenceassessment

Impact on eachdirect and

indirectconsequence

criterion

Exposureassessment

PLES2PLES1


indirectconsequence

criterion

PLES2


indirectconsequence

criterion


indirectconsequence

criterion

PLES2PLES1 PLES2

PLE2PLE1

outbreak scenarios

outbreak scenarios

P11

Disease outbreak in commercial pigs

Disease outbreak in wild pigs

Disease outbreak in backyard pigs

small

small

medium

P12

P13P17

smallmedium

large

largelarge

medium

P26P25P24

P23

P22

P21

P20

P19P18

Uncooked scraps not discarded

commercial pigs exposed

wild pigs exposed

backyard pigs exposed

No outbreak No outbreak

P10 P16

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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

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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

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Risk estimation

combination of likelihoods and consequences

‘unrestricted risk estimate’

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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’

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Risk management


Risk Assessment

Risk Management

Risk Communication

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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

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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

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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

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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

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Components of IRA


Risk Assessment

Risk Management

Risk Communication

World organisation for animal health

12 rue de Prony75017 Paris, France

Tel: 33 (0)1 44 15 18 88 Fax: 33 (0)1 42 67 09 87

Email: [email protected]://www.oie.int

Thank you for your attention

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