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Examination of the Import Risk Analysis Process – Submission by the AVPA Committee on Exotic Diseases and Importation

The Australasian Veterinary Poultry Association (AVPA) committee on exotic diseases and importation appreciates the opportunity to respond to the Department of Agriculture (DA) request to comment on aspects of the Import Risk Assessment (IRA)

The AVPA has been a recognised stakeholder for issues involving the importation of hatching eggs, poultry meat and table eggs into Australia. The AVPA also provided submissions about the importation of non-poultry avian species.

The Committee understands that the purpose of examining the IRA process is to ensure that robust arrangements are in place to minimise the risk of exotic pests and disease incursions in Australia.

The Committee agrees that the mechanisms are important but just as important, if not more so is the quality of the decisions, the ability to accept technical arguments and the understanding that while epidemiological, ecological and the pathogenesis of the microbiological process could differ between species, in the absence of direct data on one species (eg chickens) existing data from another closely related species (eg turkeys, ducks) must be considered in order to arrive at a conservative risk analysis. In this context a different weight should be given to absence of evidence versus evidence of absence.

The Committee understands that the examination of the IRA process will consider:

transparency and acknowledgement that a range of valid scientific views may be present and need to be considered appropriately during the consultation process

the use of external scientific and economic expertise

consideration of regional differences in animal or plant health status during the IRA process

The above will be addressed by the committee in the context of the questions that the Department provided to assist the response.

Q1 What extra information would you like to see in the IRA Handbook?

The handbook provides sufficient information about the main risk matrix (likelihood and impact) but does not provide details of the methodology used to assess the outcome of entrance, spread and establishment (the likelihood) or details of the methodology used to bring together local, regional and national impacts.

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The ALOP is explained in the Handbook as the choice of the lowest level that is not zero. However, the matrix includes a negligible level of risk (one in 1,000,000). This is not a zero level of risk and no explanation is provided as to why negligible is not an Appropriate Level of Protection especially when the uniqueness of the Australian fauna and flora is considered. While the Handbook elaborates that the ALOP was reached in consultation with the agreement of all State and Territory governments, apparently no wide consultation with stakeholders took place.

While the Handbook clarifies the criteria for an IRA, - “relevant risk management measures for a similar good and pest/disease combination do exist, but the likelihood and/or consequences of entry, establishment or spread of pests or diseases could differ significantly from those previously

assessed”, it is not clear what level of significant difference is required nor should it be acceptable that previous assessments necessarily provide a sufficient framework for such a determination without a wider consultation.

Q2 Does the IRA Handbook make clear how and when stakeholder consultation occurs during an IRA?

The outline of this process is generally clear. However, the wordings “will consult, whenever necessary” require further clarification and specifically identifying why it should not be necessary to consult stakeholders on all IRAs.

The determination of the stakeholders that should be involved in the consultation process is unclear. For example, in the case of agricultural commodities while stakeholders that maybe directly impacted can be identified relatively easily, consultations on potential environmental impacts (fauna and flora) from such commodities appear to be less comprehensive and without clear opportunities for conservation bodies, wildlife societies or the Australian Wildlife Health Network to participate. The lack of appropriate consideration of the impacts of chicken meat imports on individual endangered and threatened species is one example.

There should be a requirement to consult directly with environmental agencies and conservation societies even when the commodity is an agricultural commodity.

There should be a requirement that the RAP team includes at least one scientist with environmental credentials.

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Q3 At what points of the IRA process would you like to be able to provide input?

Ideally, input should be sought before the ALOP is determined.

While Australia decided that the appropriate level of protection should not exceed Very low Risk, no wide consultation with stakeholders took place. Arguments could be mounted that it is not appropriate to have this ALOP for all diseases of quarantine concern, for all elements (and especially not environmental elements) or for all commodities.

Whether the acceptable level of protection for agricultural commodities and for Australian fauna and flora should be the same is also a debatable aspect that should be reviewed.

The ALOP should also be guided by the level of scientific knowledge and the level of uncertainty.

Before the IRA panel is chosen to enable suggestions with respect to the provision of scientific advice DA in the conduct of the IRA

During the ESG deliberation in order to contribute to its consideration and be able to directly exchange scientific arguments.

Q4 How can the department improve consultation during IRAs? Please provide examples if possible. Consultation is a unique opportunity for exchange of views at the early stages, the Technical Issue paper stage as well as the IRA stage, provided that the consultation process is inclusive, meaningful and acknowledges that a range of valid scientific opinions exist and need to be appropriately explored. For example Chlamydophila psittaci (formally Chlamydia psittaci) a disease agent with a significant potential impact on wildlife in Australia was considered as an agent of quarantine concern by import risk assessments that examined the importation of flamingos (Technical Issue Paper 1999) and psittacine birds into Australia (Technical Issue Paper 1999) because “tetracycline resistant strains of Chlamydophila psittaci have been reported overseas, including in the UK and these strains are not known to occur in Australia. In reply to AVPA concerns about the exclusion of this agent, the Risk Analysis panel argued that “The RAP acknowledges the human health aspects of Avian Chlamydiophilosis. …..Multi-resistant strains have been found in ducks. However, as this IRA will be considering only the importation of uncooked chicken meat, these strains were not considered to be relevant to this IRA. This is an example of a ‘non productive consultative’ process and taking a position based on a narrow argument about ‘lack of evidence’ rather than considering relevant evidence available from other species.

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Logic would suggest that when evidence is available from one species of poultry but not from another it could reflect either higher prevalence (but not necessarily absence) in one species or a higher opportunity for surveillance and/or research in one species. It does not necessarily reflect that multi-resistant species are not present in chickens.

Furthermore, the Australian chicken meat IRA stated that Chlamydophila psittaci has no potential for transmission in chicken meat although the agent infects domestic chickens (Generic Import Risk Analysis Report for Chicken Meat, Part A, 2008) This is inconsistent with the NZ import risk assessment (1999) ‘Chicken Meat and Meat products Turkey meat preparation from the UK’ where Chlamydophila psittaci is listed as a disease with a potential to be transmitted in turkey meat. It is inconsistent with the draft chicken meat and duck meat for human consumption NZ IRA (2013) that stated that “Infectivity is concentrated in the respiratory tissues and intestinal tract although some infectivity can be detected in muscle and renal tissues. Infective tissue is therefore likely to remain following evisceration”. This inconsistency demonstrates not only the inconsistency between 2 IRA but more so the reluctance to consider all available data and hence a sub-optimal process of consultation. It may not be practically possible to have all relevant experts on the IRA panel but consultation with external experts in the relevant field should be meaningful and not limited to a narrow interpretation of available data (e.g. reported in ducks hence not relevant to chickens or ‘not reported’ hence regarded as unlikely). As stated by DAFF in its dispute with NZ about importation of apples - there is no single correct view of science and therefore a greater level of accommodating the view of other experts during consultation is required. This can be achieved through the establishment of comprehensive guidelines for consultation and assessment of stakeholders’ scientific input. Q5 How can the department provide greater assurance of its technical expertise? “An expert is a man that made all the mistakes which can be made in a narrow field” (Niels Bohr)

The case above does not reassure stakeholders of the level of technical expertise when very narrow interpretations prevailed and there are inconsistencies between other Technical Issue papers, the NZ Chicken Meat IRA and BA Chicken Meat IRA. It also does not reassure stakeholders when risk is dismissed because a certain phenomenon has not been reported or when infectivity is not considered beyond a very narrow set of circumstances.

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Risk assessment is sometimes about drawing a line where there are very few dots to connect. It is the ability to draw a line under these circumstances that distinguishes the expert from the novice and the mediocre.

Greater assurance can be achieved by making the process more transparent through a requirement for each scientific point raised by stakeholders to be addressed in detail and additionally ensuring transparency in the eminent scientific group responses. This point will be addressed elsewhere.

Expertise is more than knowledge and experience – it is the ability to recognise grey areas, the ability to accept that scientific data can lead to more than one outcome and such outcomes could be fully justified. It is the understanding that there may be more than one correct outcome and it is the ability to recognise that even the best risk analysis is merely a reflection of limited knowledge in a very complex environment – it is the ability to recognise uncertainties as a significant element of a risk rather than regard them as a reliant predictors of likelihoods or impacts.

DA stated in its dispute with NZ about apple importation into Australia (Geneva Sep 2008) – “New Zealand’s criticism flow from a broad argument that there is a single correct view of science; that for there to be two opposing views in any scientific disagreement means that one of those views must necessarily be wrong. This is simply not the case”. This comment should guide DA during the IRA process. DA’s scientific views may not necessarily be wrong but neither must comments from stakeholders that oppose DA views be wrong. DA must be seen to be more accommodating of opposing scientific viewpoints especially in areas of significant uncertainties.

There is a difference between rejecting a 'no risk' policy and adopting a policy that merrily accepts the risks of the unknown under the banner of lack of current scientific data. Or ‘not reported’.

There are significant issues with a policy that does not recognise freedom of a country from a multitude of variants (virulent or non-virulent). A technical outcome that does not place significant weight behind these types of uncertainties does not inspire confidence in the scientific depth of the policy or/and the ability of any Departmental process to assess future impact. As an example; in the entire CM IRA not once was the possibility of introduced agents, with no apparent clinical impact, to combine with Australian disease agents considered. As the ILT virus demonstrated - recombination between imported agents and existing Australian disease agents could lead to a significant impact (Lee et al (2012) Science Vol 337, N0 6091 page 188). Although a disease agent is already present in the country, the introduction of apparently non-pathogenic variants of apparently no

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pathological consequences could lead to an impact beyond what the local agent has demonstrated in the past. This is more a criticism of the policy than criticism of the process but it is sometimes difficult to separate the process from the policy.

The perception of the technical expertise of DA is a continuous process that is not influenced only by IRAs. DA handling of a myriad of technical issues is continuously being assessed and has a long term impact on the way that stakeholders view DA’s technical expertise.

In this context the approach to quarantine facilities in Australia serves as another example where DA is perceived to be an organisation more influenced by a theoretical risk assessment than practicalities. The building of an animal quarantine facility to accommodate all species in one location should be of concern when other groups of experts (eg the AVPA, AVA and other stakeholders) pointed out the practicality of risks but there seem to be a view dominating the decision that risk management is an infallible system and this demonstrates a rather naïve scientific approach or a lack of experience.

DA Policy review of the risk management of avian paramyxovirus 2 and 3 of hatching eggs of turkeys and domestic chickens was sent to WTO in August 2013 with DA’s recommendation. This was done prior to stakeholders responding to the recommendations. DA may have an obligation to inform WTO of pending reviews (does this include a full draft policy review?) but perhaps greater caution should be exercised in such circumstances to ensure that such documents are comprehensively accurate before such notifications are dispatched to WTO.

DA is being assessed not only on final IRAs outcome but also on the

quality of Draft IRAs. When 33 arthropod, 26 fungal and 7 viral pests were added to the pest categorisation table, as a result of contribution from one jurisdiction (WA contribution to the IRA on stone fruit from USA), it does not reflect well on DA’s comprehensive technical understanding. One would not expect the entire technical wisdom to reside in DA but earlier consultation with experts before documents are drafted is likely to increase the assurance of technical depth.

Recognition of the limited knowledge among DA staff of wildlife diseases their epidemiology and impact must be reflected in the consultation process. The process and its risk consideration should also reflect specifically the limited knowledge of wild life disease epidemiology and wild life ecology in Australia. Wider consultation than with the Dept of Environment and Heritage must take place in order to increase the level of confidence that the scientific process involved in an IRA benefits from a broad range of wildlife flora and fauna expertise.

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Q6 How can the department improve transparency in the scientific elements of the IRA process? Questions 6 and 8 were partially answered in question 5 but improvement in transparency could be further addressed by increasing the transparency of the Eminent Scientific Group (ESG) review process and part of this transparency should be addressing each/most scientific argument (s) that are presented by stakeholders rather than a brief summary report by the ESG.

For example, the AVPA in the context of the chicken meat IRA, argued a multitude of aspects on many scientific grounds but the ESG response was generic, short (1 page) and did not address the specific points raised by the AVPA. The points below are only a few examples;

1. Possible discrepancy between the risk assessments of zoonotic agents by 2 agencies was highlighted for Salmonella Enteritidis and Salmonella Arizona.

2. Zoo birds were not listed under any of the groups in the exposure

assessment and the impact on zoo birds and rare collections was not fully assessed despite the fact that a significant number of zoo birds are fed raw chicken products.

3. Scientific data was provided by the AVPA that the cat, the rat and

some invertebrates are more than just mechanical carriers.

4. Scientific data was presented that Arboviruses should not be excluded from the list of agents of quarantine concern because of “lack of potential for transmission in chicken meat”.

5. Scientific evidence was presented by the AVPA that oral transmission

of West Nile Virus is possible.

6. AVPA provided scientific evidence that suggests that carrier stage and involvement of wild birds in the spread of avian pneumovirus is possible.

7. The susceptible Australian population is larger than those households

(7%) with backyard poultry regarded in the IRA as the target population at risk (it also consists of households with aviary and cage birds 16%).

8. Scientific evidence was presented that humans are not a dead end

epidemiological entity.

9. Metapneumovirus was assessed to have an overall risk of VERY LOW. Reasons were brought forward to illustrate that the overall risk may be higher than postulated and scientific data was provided by the AVPA to show inconsistencies in statements in the IRA and available scientific literature.

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10. AVPA highlighted a significant difference in risk outcome for the same

diseases between NZ CM IRA and the Australian CM IRA but it does not appear that the discrepancy was considered by the ESG.

There may have been good scientific reasons to reject the AVPA arguments but no reasons were made public by the ESG. Clearly contentious scientific aspects require a more detailed response than a generic response by the ESG.

The ESG concluded unanimously that the Chicken Meat IRA Team had properly considered the 21 submissions received from stakeholders on the final draft Generic Import Risk Analysis Report for Chicken. This does not provide any significant level of transparency as it does not reassure the submitters that indeed each of their arguments was directly and properly assessed by the ESG. It does not reassure stakeholders that their arguments were understood and assessed by the ESG directly against the scientific data that they provided. Q7 If the ESG model were to be reconsidered, what type of model would you like to see used?

The composition of the ESG should not be subject only to BA decision.

The ESG procedure should allow for face to face meetings with stakeholders.

Q9 Noting Australia’s international obligations, and the way in which differences in pest and disease status are currently considered, how would you like to see regional differences integrated into Australia’s import risk assessment framework?

Within the regional context the following requires consideration

That Australia is the only country that is a continent

That there are unique regional flora and fauna diversity in Australia

There are threatened and endangered species

There are significant difference between risks to agricultural resources and environmental resources

That the determination of the Appropriate Level of Protection is “the Member’s sole prerogative. No-one may impinge on that prerogative – not trading partners, not WTO panels, not the Appellate Body” (Australia submission, Geneva 2008)

o In this context there must be recognition that the same ‘ALOP may not be suitable for all elements and commodities analysed in an IRA.

That the dilution effect that a risk based on a national impact imposes on regional impacts is particularly of concern for environmental impacts.

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1. The Matrix rules for combining qualitative likelihoods are based on 3 elements; entry, establishment and spread. The likelihood of entry is dependent on 2 elements; the probability of importation of an agent and the probability of distribution. The entry level applies to the arrival of a pest/disease agent anywhere in Australia and the distribution level applies to spread within Australia after arrival. This is the component of significant importance in the context of regional freedom. Many components could affect regional freedom from a pest or disease agent and thus the probability of spread. These include:

Ability to travel between regions (natural barriers)

Specific limiting conditions (absence of vectors etc)

Movement restrictions

Early recognition

Although FAO defines ‘A pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled’’ there are ample examples of pests/disease agents that have not spread even though no officially controlled movements are in place. 2. Examples of disease agents in Australia that have not spread to all regions are; 2.1.The PPMV1 outbreaks that occurred in Victoria, NSW and Tasmania provide an example of an agent that has not been eradicated and has not spread across all jurisdictions in Australia although no official movement restrictions are currently in place. An economical or environmental assessment of the impact is unlikely to define PPMV1 as a disease of a national economical significance or even of a regional economic significance. Yet, should imported products from countries with PPMV1 be allowed into regions like WA, SA, Tasmania, or Queensland?

2.2 Some classes of ILT like classes 8 and 9 that emerged following recombination between Australian mild vaccine strain (SA2) and an imported overseas vaccine class 7 (Lee et al Science Vol 337 July 2012) have not been reported to have spread beyond 2 jurisdictions (Epidemiology of recent outbreaks of infectious laryngotracheitis in poultry in Australia (Blacker et al AVJ Vol 89, 2011) despite a lack of official movement restrictions.

2.3 Salmonella Enteritidis has been detected in Qld poultry flocks (http://www.daff.qld.gov.au/__data/assets/pdf_file/0010/73198/Salmonella-enteritidis-program.pdf but long term Salmonella surveillance in NSW and Victoria supports the view that it has not been found in poultry outside Queensland although there are no official movement restrictions of poultry and poultry products and SE phage type 26 is endemic in Qld layer flocks but not in other jurisdictions https://www.google.com.au/webhp?sourceid=chrome-

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instant&ion=1&espv=2&ie=UTF-8#q=Arzey%20SAlmonella%20enteritidis%20in%20Australia.

All the 3 examples above demonstrate that the requirement for an agent or pest to be officially controlled does not allow consideration of situations when agent/pest does not spread although no official movement restrictions are in place.

Overall, if an agent/pest is already present Australia but has not managed to spread to a certain region, it could be argued that the likelihood of spread as a result of an additional entry through importation is unlikely to be significant. This may be the case unless the arrival of the pest in Australia changes some fundamental epidemiological or ecological aspects either immediately or with time, or the imports arrive directly in the free region.

Importation of large volumes of products with the potential to harbour pests/disease agents may affect the barriers and lead to spread to a free region even though in the past some natural elements may have protected this region. In the context of a unique country like Australia that is also a continent, natural barriers maybe as effective as official movement restrictions and a change in equilibrium across the continent may lead to changes in the status in a free region regardless of absence of movement restrictions.

3. There is another element to the risk of incursion into a free region – unforseen changes to climatic and/or ecological conditions or adaptation of a pest with time to a different set of climatic conditions. The movements of cane toads into southern parts of Australia serve to illustrate the capacity of pests to adapt over time.

Although this may happen regardless of imports if a pest is already present in some regions of Australia, the introduction of a different sub-population of the existing pest through the imports may have a significant impact on the rate of adaptation and ability of the population to invade a previously free region.

The Sanitary and Phytosanitary (SPS) guidelines do not appear to have sufficient scope to address such threats.

Peter Doherty in his book - The Sentinel Chicken (2012) provides a fascinating example of the different regional impact of mosquito borne diseases like malaria on honeycreeper species of birds (Amakihi) in Hawaii depending on their behaviour and the extent of their movement down the mountain to altitudes that the Plasmodium relictum occupy. He also mentioned that only 20C rise in temperature may be required to wipe out the barrier to the spread of the mosquitoes. It also demonstrates the need to recognise the value of regional or even district freedom independently of the national impact and above all the need of any sound analysis of the impacts of imported pests or disease agents to address in detail pertinent ecological aspects of a variety of native fauna or flora in order to provide a higher level of confidence than what was

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exemplified in the chicken meat IRA where the impact on endangered species .was apparently not considered.. 4. The SPS Agreement defines the concept of an ‘appropriate level of sanitary or phytosanitary protection (ALOP)’ as the level of protection deemed appropriate by the WTO Member. Australia elected, with apparently inadequate consultation with stakeholders, the ALOP to be Very low. This may be appropriate for agriculture industries but not necessarily for non-replenished commodities like the environment – Australian unique flora and fauna. It also may not be appropriate when regional freedom needs to be protected and the selected level of protection may need to be adjusted in order to allow such protection. The existing risk matrices of likelihoods and consequences do not allow a sufficient weight to be placed on long term changes in likelihoods of spread and establishment, nor do they guard against the dilution of the effect of regional consequences when translated under existing Matrices into a national risk assessment. For example; a significant regional impact would translate to an impact of minor significance at the national level and an impact of a minor significance at a regional level translates to an indiscernible impact at the national level. This may create a situation where despite high likelihood of spread the risk is acceptable since the impact at the national level is indiscernible or very low. For Newcastle Disease impact under outbreak scenario 4 (spreads and becomes endemic in Australia), the Generic Chicken Meat IRA (2008) stated that “A generalised outbreak of ND will have no discernible impacts on this criterion (Impacts on the environment, including biodiversity, endangered species and the integrity of Ecosystems) at the national or State/Territory levels, but is likely to have minor impacts at the district/region level, if wild birds are clinically affected.

No explanation is provided and there is no apparent analysis of the impacts on biodiversity of different species or other biodiversity considerations listed in Part B. of the Generic Chicken Meat Import Risk Analysis (2008). Likelihood and impact Practically the likelihood of incursion into a region could be redundant since even if a likelihood of such an incursion was determined to be High, the national impact must be low or above to produce an outcome breaching the current ALOP (Australian risk assessment framework page 31). There is a need to provide a clearer approach to the methodology used to assess the impact at the regional level on the national level. Regardless of the size of the jurisdiction it may not be easy to accurately assess the likelihood of

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incursion but for a small jurisdiction or for a jurisdiction with a relatively small industry that may be affected by imports, it may not be easy to demonstrate that a discernible impact at the regional level would produce an impact that is sufficiently significant at the national level. Yet this jurisdiction could be the size of a large country in Europe! Regional risk should not necessarily be assessed through the national framework The concept of recognising a region/state as a disease/pest free area is well recognised in the SPS guidelines and the risk to environmental diversity should

take precedence over the risk to agriculture (nationally and regionally)

be assessed by an independent environmental expert panel

not allow the dilution effect of the impact when a regional impact is translated into a national impact.

use a different Appropriate Level of Protection than is used either nationally or generally for other elements of impacts for the regional and/or environmental preservation of diversity.

AVPA Committee on Exotic Disease and Importation 10 September 2014