World Organisation for Animal Health

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

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

Risk and risk analysis

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’

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

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

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

Making decisions

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’

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)

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

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

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

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

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

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:

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

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 …

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)

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.

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

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

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 …

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

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 ?

Import risk analysis

Context

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

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

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

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

Hazard Identification Risk communication Hazard Identification Risk Assessment Risk Management Risk Communication

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

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

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

Hazard identification Risk Assessment Risk Management Risk Communication

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

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

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

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)

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

Hazard Identification Risk assessment Hazard Identification Risk Assessment Risk Management Risk Communication

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

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

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

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

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

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

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

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

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 …

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 ?

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

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

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

release scenario

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

outbreak scenarios

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

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

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

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

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’

Hazard Identification Risk management Hazard Identification Risk Assessment Risk Management Risk Communication

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

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

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

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

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

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