REPORT ON THE IMPORTATION OF COOKED CHICKEN MEAT INTO AUSTRALIA

APPENDIX 3 - CHAPTERS 6-8 OF THE COMMITTEE'S 1995 AQIS REPORT

CHAPTER 6

RISK ANALYSIS AND RISK MANAGEMENT

Introduction

6.1 Risk analysis and risk management underpin many facets of AQIS' work and, during the inquiry, this process emerged as one of the most controversial and consistently misunderstood aspects of AQIS' activities.

6.2 The Committee sought detailed information and explanations from AQIS on the theory and application of risk analysis and management.

6.3 In this Chapter, the Committee reviews this evidence. In the following Chapter, the Committee examines the process and application of risk analysis and management to specific import proposals.

No Risk vs Risk Management

6.4 The debate over risk management policy is often couched in terms which imply that Australia once had a "no risk" policy but that this has been replaced in recent times with a less rigorous policy of acceptable risk. Proponents of a "no risk" policy argue that this "new" policy endangers quarantine security for the sake of placating international trading partners or for short-term economic savings.

6.5 However, successive reviews of Australia's quarantine services have noted that a policy of "no risk" is not, and never has been, a viable quarantine policy option. For example, the 1979 report of the Senate Standing Committee on National Resources, entitled The Adequacy of Quarantine, stated:

The shorthand term "no-risk" is widely applied to Australia's quarantine policy. The use of this term is misleading and it is not accepted by the Quarantine authorities as an accurate description of quarantine policy. In practice any international trade or travel contains an element of quarantine risk. The function of the Quarantine Service is to assess the likely risk a disease or pest poses to this country, to consider probable means of entry and in the light of these factors to produce policies aimed at their exclusion. A more accurate description of quarantine policy would be the scientific evaluation of acceptable risk.

6.6 Similarly, the 1988 Quarantine Review Committee convened by Professor David Lindsay described a number of misapprehensions about quarantine risk which became apparent during the course of its inquiry. The Review Committee's report stated:

It appeared to the Committee that many of those who made submissions had the impression that Australia had always been protected by an effective quarantine system. In fact, prior to the 1950s and during the war years in particular, agricultural quarantine was almost non-existent compared to today's extensive system ... Indeed, it could be argued that the entire [agricultural] industry developed because imports of plants and animals were not being unduly restricted by quarantine.

6.7 The report stated unequivocally:

A "no-risk" policy for Australian quarantine - implying total exclusion - is untenable and undesirable and should be formally rejected. By contrast, the notion of "acceptable risk" is realistic: it reflects the fact that, regardless of the policy of the day, all imports whether or not they are legal inevitably involve a level of risk. There is a risk of accidental or deliberate entry because of imperfect quarantine methods and means of detection. Total banning of entry of materials leads inevitably to the temptation to smuggle.

6.8 The Government's 1988 quarantine policy statement, Australian Quarantine - Looking to the Future, accepted the "strongly expressed view of the Quarantine Review Committee that a policy of 'no risk' would be impossible to implement". The policy statement continued:

Such a policy would mean for example a ban on most imports. It would preclude the lawful import into Australia of genetic materials which may be highly desirable for the development of our agricultural industries. At the same time, it would increase the likelihood of an illicit trade in such materials - a trade which virtually eliminates the capacity to manage the risk involved. A "no risk" policy would also require untenable restrictions on the movement of passengers, aircraft and ships, and control over the movement of migratory birds and other species obviously is not possible. The Government therefore endorses the principle of risk management in the provision of quarantine protection and in the allocation of quarantine resources.

Risk Management Methodology

6.9 In its broadest sense, quarantine risk management involves the following steps:

• identifying the pest or disease of concern;
• identifying the means by which the pest or disease may be carried into or out of the country;
• assessing the likelihood of that event occurring;
• assessing the likelihood of the pest or disease becoming established if it entered the country;
• assessing the likely biological and economic impact of any such establishment;
• assessing any options for reducing the risk of the event occurring while allowing the import or export to proceed;
• assessing, in the light of these factors, the acceptability of the risk involved in allowing the import or export of the product.

6.10 The analysis of these factors allows AQIS to achieve a more objective basis for assessing quarantine risks and to target its resources in areas which are assessed as representing the highest risk.

6.11 The general principles of risk management are applied to the following areas of AQIS' activity:

• assessment of import proposals;
• quarantine surveillance and border protection; and
• export inspection.

Assessment of Import Proposals

6.12 The first step in the risk assessment process for imported products is an analysis of the biological factors which are relevant to the proposed importation. These factors may include:

• identification of pests or diseases associated with the product in the importing country;
• epidemiology of disease;
• possible modes of entry and vectors;
• identification of candidate hosts or vectors for disease in Australia;
• identification of biological impact of pest or disease on both industry and native flora and fauna.

6.13 The next step is an analysis of the economic factors relevant to the proposed importation. Under the GATT agreements, AQIS is not permitted to take into account the economic effect on Australian industry of the importation of the product itself, but only of the economic effect of any disease or pest which may be introduced through the importation of the product. Relevant economic considerations may include:

• cost of programs required to manage potential exotic pest and disease outbreaks;
• cost of strategies designed to reduce risk to "acceptable" level;
• cost to local industry of any outbreak of the exotic pest or disease; and
• cost to local industry of the exclusion of the product.

6.14 The risk assessment process is shown in Figure 6.1.

6.15 The process of weighing the relevant biological and economic factors in relation to particular proposed importations is extremely complex and there is some debate over the extent to which quantitative probability values can meaningfully be placed on the various risk factors.

6.16 One attempt to assign quantitative value to risk levels is made by the Office International des Epizooties in its guidelines on import risk analysis for animals and animal products. The aim of the OIE guidelines is to establish a process for calculating "an unrestricted risk estimate", defined as an estimate of the risk associated with the importation of a commodity in its usual commercial form. The guidelines state:

The unrestricted risk estimate is the product of two probabilities, namely the probability of agent entry and the probability of exposure of susceptible species in the importing country. The probability of agent entry is the probability that at least one animal import is infected with the agent.

6.17 The probability that the agent will be present in the commodity at the time of import may be affected by the following factors:

• species, age and breed of animal;
• sensitivity of diagnostic tests;
• agent predilection sites;
• ease of agent contamination;
• pH;
• temperature and duration of heat processing;
• temperature and duration of freezing;
• other processing procedures;
• temperature and duration of storage;
• transit temperature and duration; and
• additives and treatments.

6.18 The number of "animal import units" being imported also significantly influences the probability of agent entry.

6.19 The probability that the agent will be exposed to susceptible species in the importing country is described by the OIE guidelines as "the likelihood that the commodity is exposed to animals or humans in the importing country and that agent transmission, infection, disease, and disease spread occur combined with the likelihood of these events being detected".

6.20 A number of factors may influence the probability of the exposure of a particular commodity to animals and humans in such a way as to result in infection, including:

• the nature of the agent;
• the intended commodity use and distribution;
• presence of potential vectors, which may be different from those in the country of origin;
• calendar period of importation;
• primary, secondary and intermediate hosts of the agent;
• nature of the commodity;
• human and animal demographics;
• mode of transmission of the disease;
• customs and cultural practices; and
• animal health legislation and compliance.

6.21 The OIE guidelines state that, in preparing a risk assessment for a proposed importation, the importing country should identify the scenarios which may result in the exposure of the commodity and the infecting agent to animals or humans. The complete sequence of events in the scenario should be identified, and probabilities assigned to the occurrence of each event. In this way, an "objective" assessment of risk may be produced so that "the exporting country may be provided with a clear and documented decision on the conditions imposed for importation, or refusal of importation".

6.22 If the unrestricted risk estimate is judged to be too high to allow the importation of a commodity in its usual commercial form, it may still be possible to apply certain risk reduction options to enable the importation under restricted conditions.

6.23 Options which may exist to reduce the risk associated with particular importations include:

• choice of the origin of the commodity;
• restricting the destination;
• pre- and post-shipment quarantine;
• diagnostic testing with tests of estimated validity parameters;
• vaccination;
• processing, maturation and storage for a specified time and temperature;
• treatments, eg. heat treatment for a specified time and temperature, use of veterinary drugs, washing of embryos, fumigation of eggs, etc.

6.24 The application of a risk reduction option can reduce either the probability of agent entry or the probability of exposure to susceptible animals, or both. The OIE guidelines note "the product of these two probabilities is referred to as the restricted risk estimate".

6.25 However, in evidence to the Committee, AQIS' Executive Director, Mr Paul Hickey, emphasised that the "methodology for the development of quantitative models for assessment of risk is still very much an uncertain one", and that so-called "quantitative" analyses are not necessarily any more objective than "qualitative" analyses. Mr Hickey pointed out that the problem with assigning numbers to the probability of events occurring is that a judgement must still be made about whether such numbers constitute "low", "medium" or "high" risk. In relation to the quantitative risk assessment performed by the New Zealand quarantine service for the importation of Canadian salmon, Mr Hickey said:

I think its assessment is that there is the possibility of one disease introduction occurring with one billion kilograms of product entering the country. That then potentially leads you into a debate about what the threshold percentage is in determining low risk - is it 10 per cent, five per cent, one per cent, 0.01 per cent? Where do you rule the line? The fact is that the assumptions and so on that have to go into a quantitative model are in themselves so uncertain that, when you get down to very fine percentages, the results in effect are meaningless.

6.26 Requests to import animal and plant products may be made by foreign governments or industries, the Australian government, or Australian industries and private individuals. All requests are assessed by AQIS to determine the risk of entry of unwanted pests or diseases as a consequence of the importation. These assessments are known as Import Risk Analyses (IRAs).

6.27 Recent examples of IRAs are:

• Disease Risks Associated with the Importation of Uncooked, Wild, Ocean-Caught Pacific Salmon Product from the USA and Canada, Draft, May 1995; and
• Importation of Cooked Chicken Meat from the USA, Thailand and Denmark, Position Paper, May 1994.

6.28 The IRAs for the importation of Pacific salmon and cooked chicken meat have been prepared by AQIS in response to access requests from the Canadian, and the Thai, US and Danish governments respectively.

6.29 AQIS has also recently commissioned the Bureau of Resource Sciences (BRS) to perform Pest Risk Analyses (PRAs) on maize, barley, sorghum and wheat from the USA and Canada, and barley from Finland. These PRAs are the scientific basis on which AQIS has developed a manual designed to manage the risks associated with importing grains. The manual is the Imported Grain Procedural Manual, dated 15 September 1995.

6.30 The PRAs for the importation of grain have been prepared in response to demand from Australian industries, particularly the beef feedlot industry, that the drought induced shortfall in Australian grain production be supplemented with imported product.

6.31 The risk analyses and management protocols for all three commodities are draft documents and importation protocols have not yet been approved. However, several Australian industry groups affected by the proposed importations argued that they posed significant quarantine risks and that the draft IRAs did not address these risks adequately. Industry concerns included:

• scientific adequacy of the AQIS risk analysis;
• adequacy of proposed risk reduction measures;
• adequacy of consultation with affected industry; and
• relationship between trade and quarantine considerations.

6.32 These issues are considered in detail in Chapter 6.

Quarantine Surveillance and Border Protection

6.33 The risk assessment and risk management procedures for border protection activities differ in some ways from those applying to requests for specific importations, since the pests and diseases of concern, and the potential means of entry are not limited to one commodity group. Accordingly, AQIS must identify a range of pests and diseases of quarantine significance and develop interception strategies which target the agents at their most likely point of entry.

6.34 Border protection activities include general quarantine activities at airports, seaports and mail exchanges and the Northern Australian Quarantine Strategy. The Committee examines the NAQS program in detail in Chapter 10.

6.35 As with all risk assessment, the process of assessing the level of risk posed by particular exotic agents involves consideration of many factors, including the likelihood of entry, the possibility of controlling or eradicating the agent post-entry and the likely biological and economic impact of the establishment of the agent. Assessed levels of risk may vary over time as more becomes known about the biology of particular pests or diseases, or as strategies for combatting them evolve. Professor Lindsay, in his review of quarantine services in 1988, recognised this proposition when he recommended that quarantine activities should be subject to regular external review. In response to this recommendation, in 1995 the Government established a committee chaired by Professor Malcolm Nairn to review quarantine.

Export Inspection

6.36 AQIS' Executive Director, Mr Paul Hickey, informed the Committee that risk management was not only applied to import protocol development and quarantine strategies, but was also the methodology used in certifying goods for export. Mr Hickey said:

The approach to inspection of our exports is also risk based. We do not inspect everything with an intensity or frequency that would generate a sort of no-risk result. Let me give you an example with chemical residues in beef. We rely, as the basis of our certification that the product is safe, wholesome and fit for human consumption, on the national residue survey results, which show, for example, that the organochlorine content in Australian beef is less that 0.1 per cent. That, in our mind, constitutes an acceptable level of risk. But there is no guarantee that Australian beef is entirely free of chemical residues. We do not sample every carcass to ensure that that is the case. So that is one example of us taking a risk management approach.

6.37 Mr Hickey added:

That is the case for every other commodity that Australia exports, including grain. Grain is only sampled. It would be physically impossible to inspect everything that went through to ensure it was completely free of weeds or other contaminants. We do not do substantial amounts of residue testing on those grains. We adopt the risk approach - and so it is with imports.

CHAPTER 7

RISK ANALYSIS AND RISK MANAGEMENT - CASE STUDIES

Introduction

7.1 At the outset, the Committee determined that it had neither the expertise nor the mandate to adjudicate on issues of scientific dispute in relation to particular risk assessments. However, the Committee considered that three issues which arose during the course of the inquiry could be used as valuable case studies to illustrate and evaluate in detail aspects of AQIS' risk assessment procedures. The three issues are:

• the draft import risk analysis on the importation of uncooked Pacific salmon from North America;
• the risk management procedures developed for the importation of grain; and
• the draft import risk analysis on the importation of cooked chicken meat from Thailand, the USA and Denmark.

7.2 These issues are addressed below.

Uncooked Pacific Salmon

7.3 Quarantine restrictions on the importation of fresh and frozen Pacific salmon, genetic material and trout product have been in place since 30 June 1975. These restrictions were implemented as a result of a recommendation made in September 1973 by the Australian Fisheries Council, comprising Commonwealth and State Ministers for Fisheries. The recommendation aimed to protect trout recreational fisheries in Australia from specific exotic diseases. Canned salmon and salmon smoked at certain specified temperatures, however, were not prohibited.

7.4 Since 1975, Canada has been seeking access to the Australian market for uncooked salmon products. In 1994, Canada requested GATT consultations with Australia on these restrictions and the United States joined in these consultations. Australia, as a contracting party to the General Agreement on Tariffs and Trade, is required to consider market access requests on their scientific merits.

7.5 Accordingly, AQIS prepared a draft IRA addressing the quarantine issues raised by the access request.

AQIS' Draft Risk Analysis

7.6 The draft IRA prepared by AQIS in response to the access request for uncooked, wild-caught Pacific salmon products from Canada concluded that, subject to certain risk reduction measures, the quarantine restrictions on these products should be lifted. AQIS found that the risk of introducing disease by importing the product for human consumption was insufficient to warrant the continued exclusion of the product. The draft IRA stated:

In the course of this risk analysis, no evidence has been found of the spread of diseases via fish products for human consumption, despite the wide scale movement of salmonid product within and between continents. Prior to 1975, Australia imported substantial amounts of uncooked salmon product.

7.7 Twenty four diseases reported in Pacific salmon from Canada and the USA were considered in the draft IRA, of which 21 were judged to be of "minor or negligible concern on the basis that they present negligible risk of introduction into Australia or are unlikely to cause significant problems if introduced".

7.8 Three of the diseases, namely Aeromonas salmonicida or furunculosis, Renibacterium salmoninarum and infectious haematopoietic necrosis (IHN), were judged to be of particular concern. In the draft IRA, AQIS considered the risk of introducing the three diseases was acceptably low when the following three factors were taken into account:

• the nature of the original product;
• the effects of processing; and
• the proposed use of the product.

Nature of Original Product

7.9 AQIS considers that the risk of disease being present in fish from which the imported product will be derived is relatively low. According to AQIS, the risk posed by wild caught salmon is significantly less than that posed by fish from aquaculture environments. This is because susceptibility to disease in aquaculture environments is affected by management disease control measures, protection from predation and the high stocking densities in netpens.

7.10 In the draft IRA, AQIS also noted that specifications relating to the age of the fish decreases the risk of disease being present in the fish from which uncooked product will be derived. According to AQIS, fish commercially harvested from the ocean are subadult/mature fish and therefore have been at sea for a sufficiently long period of time for infections contracted in freshwater to have resolved or stabilised. AQIS noted that as these fish have not yet returned to freshwater to spawn, they have not been subjected to associated increased stresses and infections, particularly from the IHN virus.

Effects of Processing

7.11 AQIS considers that the effect of processing will be to decrease the risk of disease introduction further. In the draft IRA, AQIS stated:

Most physical processes such as cooking, freezing and thawing and changes in pH, while not eliminating micro-organisms, will significantly reduce the number of viable organisms present.

Prposed Use of the Product

7.12 AQIS considers that even in the event that viable pathogens are present in salmonid product imported into Australia, the risk of contact with susceptible animals is low. The draft IRA states:

Disease introduction would require the disposal of uncooked product in significant volumes and this product would have to be disposed of in a way that exposes susceptible animals to infection. Most product trimmed in commercial kitchens and the home will be disposed of in the commercial garbage system; fed to pet animals; placed in the garbage disposal unit or composted. These routes of disposal are considered low risk because dilution, burial, combustion or digestion would effectively protect the aquatic environment.

7.13 The draft IRA recognised the possibility that uncooked product might be used as bait or fed to fish in natural waterways by picnickers, but concluded that these risks were low. It noted:

Relevant considerations include: that salmonids are only present in a limited area of Australia and these populations are seldom in close contact with human populations; that most recreational fishing occurs in marine waters where there are few salmonids; and that it is unlikely that picnickers/fishers would discard significant quantities of imported salmon in the raw state.

Risk Reduction Measures

7.14 As indicated earlier, AQIS analyses the risk of introducing disease posed by a particular product. This is also known as the "unrestricted risk estimate". In formulating a draft IRA, AQIS may also specify risk reduction measures which must be applied to the product to render the risk as low as possible. In relation to the proposed importation of uncooked Pacific salmon, AQIS has specified the following risk reduction measures:

• the fish must be processed and packed in [Canadian] Federally approved establishments;
• the fish must be inspected and graded "A/first", that is, visibly free of disease lesions and other blemishes and defects; and
• the fish must be eviscerated, had the head, including the gills, removed and received a final wash.

7.15 These measures are designed to reduce the risk of disease pathogens being present in the imported product in the following ways:

• inspection of fish and rejection of diseased or otherwise injured fish "will significantly decrease the risk of disease entry as such fish are likely to contain more pathogens either from the disease process or as a result of decreased immune competence resulting from stress";
• removal of the viscera and head, where the highest titre of pathogens are concentrated, will reduce the risk that pathogens present in fish carrying disease but with no visible symptoms will be imported; and
• final washing of the fish will remove gross contamination and reduce possible cross-contamination from diseased fish.

Review by the Bureau of Resource Sciences

7.16 In 1992, AQIS commisioned the Bureau of Resource Sciences to review Australia's quarantine requirements for imports of living aquatic animals and non-living products and associated materials.

7.17 In August 1995, the Bureau published its report, entitled Australian Quarantine Policies and Practices for Aquatic Animals and their Products: A Review for the Scientific Working Party on Aquatic Animal Quarantine.

7.18 The BRS report noted that there are no confirmed examples of uncooked fish products destined for human consumption introducing diseases into the aquatic environment. The report, however, acknowledged "that it would be extremely difficult for any such incursion to be definitively attributed to imports of products for human consumption".

7.19 The report recognises that the risk of introducing disease is reduced when the viscera are removed, and that the disposal of uncooked waste into domestic drains or sewer systems by consumers "appears to offer little risk of exotic disease incursion, primarily because of dilution". The report also expressed the view that there is a major inconsistency in current quarantine policy in relation to imported finfish. It stated:

[F]resh or frozen products derived from finfish other than the salmonids may be imported without specific quarantine restrictions, whereas salmonid flesh is prohibited unless treated in a manner to inactivate potential pathogens. For example, barramundi for human consumption are imported frozen into Australia without restriction from countries that have poorly defined disease status.

7.20 The report recommended that the "arbitrary distinction between salmonid and non-salmonid fish should be repudiated". It maintained that all proposed imports of finfish should be considered on a case by case basis with quarantine restrictions commensurate with the risk of disease incursion associated with the product. It concluded:

In view of the absence of documented examples of exotic disease incursions resulting from imports of products of aquatic animals for human consumption, and the international acceptance of evisceration as a means of substantially reducing the risk of disease transfer in fish for human consumption, the present restrictions on the importation of salmonid flesh for human consumption cannot be justified and should be revised.

ABARE Report

7.21 In December 1994, the Australian Bureau of Agricultural and Resource Economics (ABARE) presented a report to AQIS on Economic Impact of Salmonid Diseases: Furunculosis and Infectious Haematopoietic Necrosis (IHN). The report addressed the following issues:

• the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of furunculosis and IHN;
• the cost of control or eradication in Australia; and
• the relative cost effectiveness of alternative approaches to limiting risks.

7.22 ABARE's report looked at only two of the diseases of concern, but concluded that "the potential impact of the introduction of furunculosis and IHN to Australian waters is likely to be substantial, particularly given the high probability that the entire salmonid industry would cease operation in the event of disease outbreak". ABARE recognised that "it is difficult to make definite statements about what proportion of Atlantic salmon and rainbow trout farms would remain viable in the advent of disease introduction". Despite this, ABARE estimated that the value of lost sales of salmonids, in the event of disease outbreak, is likely to range from at least $8.5 million to over $94 million a year. According to ABARE, this estimate should be considered conservative, given the exclusion of the ocean trout and recreational trout fisheries from the analysis as well as the exclusion of price effects [ie. loss of premium prices due to loss of disease free status] and the possible underestimation of treatment costs.

7.23 As indicated earlier, risk is based on an assessment of economic risk as well as biological risk. Therefore, the probability of severe economic consequences arising from the introduction of exotic diseases increases the level of overall risk.

Industry Concerns

7.24 The Committee received considerable evidence from the Tasmanian salmon industry, maintaining that AQIS had significantly underestimated the risk of introducing disease if ocean-caught, uncooked Pacific salmon were imported from Canada and the USA. The industry argued that existing quarantine restrictions should be maintained.

7.25 The Tasmanian Salmonid Growers Association (TSGA) referred the Committee to a document prepared by the Association, entitled Response to AQIS Draft Import Risk Analysis. In this response, the TSGA disputed AQIS' conclusion that an analysis of the nature of the original product, the effects of processing and the proposed use of the product, demonstrate that the risk of introducing exotic diseases of concern is acceptably low. The TSGA maintained that AQIS did not address relevant evidence when assessing the risk. In particular, it failed to consider two significant factors, namely the economic impact of introducing diseases, and the effect on native marine species.

7.26 In summary, the TSGA maintained that:

• more than three of the 24 diseases associated with Pacific salmon are of significant quarantine concern. The TSGA advised that there are significant gaps of knowledge regarding diseases and their prevalence in wild Pacific salmon. These gaps in knowledge make assessments of risk highly problematic. The Association expressed the view that AQIS did not properly assess the risk associated with these diseases. Scientific papers accompanying the TSGA Response concluded:

The gaps in knowledge regarding diseases and their occurrence in wild Pacific salmon should be significant factors to retain the ban on imports for at least another 10 years. By then reliable disease detection methods should be in routine use.

• AQIS has significantly underestimated the likelihood that salmon product certified for importation will contain significant levels of pathogens. In support of this contention, the TSGA drew the Committee's attention to four factors. First, the prevalence of disease in wild Pacific salmon is not systematically monitored, so it cannot be assumed that they are largely disease free. Secondly, enhancement programs mean that "wild-caught" fish may have originated as hatchery stock, thus increasing the likelihood of their exposure to disease. Thirdly, most salmon are caught within 5 kilometres of river entrances on their way back to spawn, which may mean they are already more susceptible to disease. Fourthly, it will be difficult to ensure that fish are ocean caught.
• AQIS has overestimated the effectiveness of inspection in screening out diseased fish. The TSGA maintained that some of the diseases of concern are difficult to detect by visual inspection, even in their clinical stage. The Association drew the Committee's attention to a report by the Aquaculture Risk Control group in Sunderland Marine Insurance stating that "screening methods themselves are notoriously inefficient, an aspect that in our opinion has been poorly dealt with in the AQIS report". The TSGA also referred the Committee to a brief prepared by the US Congressional Research Service which called into question the sanitation standards at Canadian fish processing plants.
•  
• according to the TSGA, processing may decrease microbial loading, but may also increase it if biofilms are present on the processing equipment. The TSGA explained that a biofilm is a "community of micro-organisms embedded in polymers, attached to a surface". Biofilms may build up on equipment such as pumps, taps, valves, hoses and conveyors and will include a proportion of any pathogens present in the processing environment. The TSGA observed that AQIS failed to address the issue of biofilms. The Association was also sceptical that a final wash of the product would reduce the risk of disease. It indicated that AQIS itself acknowledges that most fish are not vigorously washed to remove all of the mucus because of the effect on the final quality of the fish. The TSGA advised that skin mucus is a recognised site for harbouring pathogens.
•  
• AQIS has significantly underestimated the risk that significant numbers of pathogens will be exposed to susceptible species. The TSGA based its view on two factors. First, AQIS did not analyse the infective dose properly. The infective dose is defined as the number of pathogens required to infect a fish with a disease. Theoretically, if the infective dose were known, and if the concentration of pathogens in the flesh or tissue of a carrier or diseased fish were known, it would be possible to calculate how much infected tissue an individual fish would need to consume to become infected itself. AQIS estimated that, on average, 100 grams of tissue infected with Aeromonas salmonicida would need to be consumed to constitute an infective dose and concluded that this was "a large amount for a salmonid". However, the TSGA presented evidence, maintaining that the amount of infected material required to infect another fish depends "on a number of physical and biological variables in the environment and affecting the host, as well as the number of viable cells in the tissue". The evidence on this matter, submitted by the TSGA, concluded that "until more is known about the pathogenicity of the different strains of A. salmonicida, the infectious dose is no more than a subjective guess". A further consideration in relation to infective doses is the probable lower immunity of Australian salmonids and native fish to the diseases of concern. TSGA's Response stated "with Australian salmonids, there must be considerable naivety to exotic pathogens. It is almost certain that their immune response to diseases will be very low. Also, there are unknown factors about immunity in the indigenous fish population and possibly amphibians which are susceptible to some fish pathogens". Secondly, AQIS did not pay sufficient attention to likely infective routes. The TSGA rejected the assertion that human and salmonid populations do not coincide and outlined several scenarios through which uncooked salmon product could be directly introduced into the salmonid environment by picnickers, yachtsmen or fishermen. The TSGA also dismissed AQIS' argument that waste disposal systems provide adequate security against the transfer of unused product to a susceptible environment. In relation to the transfer of solid wastes, Mr Carington Smith observed that sea birds scavenging at landfill sites could transmit product infected with exotic pathogens. He explained "birds are one of the major carriers. It can be intestinal or it can be mechanical - in other words, on the claws and feathers. The case histories of disease transferred by this mechanism go back 20 years. It was just brushed over in the report". In relation to liquid wastes, the TSGA maintained that they may not always be disposed of through the sewage system. The TSGA Response stated that "sewage treatment systems are inadequate for dealing with some fish pathogens. For example, MAFF, Fish Diseases Laboratory in Weymouth, UK, has just spent many thousands of dollars installing ozone and UV systems in its new laboratory. The sewage system alone was not even considered to be safe".
•  
• AQIS has largely ignored the risk posed to native species of the introduction of pathogens. The TSGA and its consultant scientists maintained that there are significant gaps in scientific knowledge of fish diseases, particularly in relation to their possible effect on native species. The Australian Animal Health Laboratory (AAHL) of the Commonwealth Scientific and Industrial Research Organisation (CSIRO) also stressed the lack of scientific data in this area in the following terms:

AAHL regards the quality and quantity of available data insufficient to allow a scientific risk assessment. Nevertheless, in the absence of scientific proof, AAHL feels that the risk of introducing disease/agents by the pertinent product may, in fact, be very small, and that the final decision cannot be based on the limited scientific data alone.

Although AQIS recognised that estimates of risk should be weighted towards more conservative judgements, the TSGA argued that AQIS failed to adopt this approach in relation to native fish. This was so, despite the fact that quarantine restrictions were originally implemented out of concern for the native and recreational fisheries.

• AQIS has largely ignored the likely economic consequences of the establishment of any of the exotic diseases of concern. Mr Shelley, TSGA Director, elaborated on this issue in the following terms:

If disease hits our salmon business and we suffer losses through lower yields of fish, through having to increase our costs by way of treating fish with antibiotics or with other chemicals, and through having to insure at greater costs, most importantly - apart from having all those add-on costs and lower yields and therefore higher cost of production - we will lose without doubt the premium for our product that we presently get on world markets. Once that happens to us, we cannot be profitable. We are probably the only profitable salmon farming industry of note in the world. Most salmon farmers are not profitable in other parts of the world, because of the disease issues. In North America, the wild fishing industry is very heavily subsidised under the indigenous population scheme by both the Canadian and the US governments; and that is a problem that we really have to face head on. When we are exporting to other countries around the world, we meet all of our competition without any subsidy whatsoever.

According to the TSGA, AQIS also failed to appreciate the findings of a report commissioned from the Australian Bureau of Agricultural and Resource Economics which examined the economic impacts of disease introduction. In its response to AQIS' draft IRA, the National Farmers' Federation also expressed concern that AQIS "chose in their draft document to pass [negative] judgement on ABARE's economic assessment".

7.27 Mr Owen Carington Smith, Chairman of the TSGA, concluded:

The whole process [the draft IRA] that we have had to address has been ill researched; the homework was poor; and throughout the whole process there has been considerable bias, which I think is quite evident in some of the points that we can pull out, where they started with the concept that they will let the product in and then have tended to address their report to meeting that objective.

Consultation

7.28 In evidence to the Committee, AQIS said that it had consulted with industry from the beginning of the risk analysis process. AQIS' Executive Director, Mr Paul Hickey, stated:

The Tasmanian Salmonid Growers Association were invited to Canberra to meet me early last year with other AQIS officers, during which time we explained the process that we intended to follow in relation to the salmon assessment. Following that meeting, it was decided that we ought to send a team of people to Canada and North America to get at first-hand the scientific information that was considered necessary to undertake the assessment. We invited the Tasmanian Salmonid Growers Association to send an industry representative along on that mission, which they did ... On those people returning to Australia, the AQIS processes of developing the draft report began ... and then the report was provided in draft form, I think in December last year, to the industry before it was released as a draft discussion document.

7.29 The Tasmanian Salmonid Growers Association expressed significant concern at the process of consultation undertaken by AQIS during the formulation of the draft IRA.

7.30 The Executive Officer, Mr Tony Smithies, indicated that, when drafting its IRA, AQIS officers did not visit Tasmania to consult with the industry, or to inspect locations and facilities. He said:

[I]n the AQIS report they tell us that there is no coincidence or correlation between salmonid and human populations. Now, they only had to come to Hobart for half a day to find out how wrong that statement was, and we are very critical. I think that really highlights the inadequacy of the preparation and the research that AQIS put into this whole document during the consultation period, and the lack of consultation.

7.31 Mr Smithies also complained that the industry had not been given sufficient time to comment on the December 1994 draft and that "our subsequent comments were ignored in any event". The TSGA felt that AQIS had assumed from the beginning that there was no real case against the proposed importation. Mr Smithies added:

[I]f we as an organisation had not got ourselves to the point where we could raise the funds to address this document, we would have just been ignored as would so many other industries.

Current Status of the Import Proposal

7.32 Following the circulation of the draft IRA in May 1995, AQIS has received "a significant number of responses ... with a range of new issues as well as expanded consideration of the issues raised in the draft IRA". On 30 October 1995, AQIS advised that, given the number and complexity of the issues raised in response to the draft IRA, an extended period of consultation would occur. In a public letter, AQIS stated:

There is a clear need to prepare and distribute for further comment a comprehensive discussion document which addresses all significant matters, including obligations under environmental protection legislation ... Even though it will be progressed as quickly as possible, it will take some time.

7.33 In its latest advice to the Committee, AQIS advised that a preliminary version of a revised draft IRA would be completed by the end of March 1996. AQIS noted that:

The revised version is expected to be more comprehensive than the draft IRA to take account of the many issues raised in the 170 submissions received in response to the draft IRA.

7.34 AQIS advised that particular attention was being given to ensuring that the revised draft IRA conforms closely with WTO and OIE requirements for scientific risk assessment. The preliminary revised version will also address socio-economic and environmental considerations.

Imported Grains

7.35 Mr Hickey advised the Committee that AQIS established a task force to examine the issue of grain importations in September/October 1994, "at the height of the drought and when concerns about access to adequate feed supplies were being raised [by] the intensive livestock industries".

7.36 Pest risk analyses were performed by the Bureau of Resource Sciences on AQIS' behalf during November 1994. The PRAs assessed the quarantine risk associated with importing wheat, maize, sorghum and barley from the USA and Canada, and barley from Finland, and transporting them to up-country areas. PRAs for oats and rye were undertaken for their importation into metropolitan areas, rather than country destinations.

7.37 In broad terms, the conclusions of the PRAs were that weed and insect pest risks are similar for all grains and may be addressed by screening and inspection. Disease risks vary according to the type of grain and the disease status of the location from which grain is sourced. In relation to disease risks, the PRAs concluded:

• wheat presents a high disease risk because of the number of true seed-borne diseases and air-borne diseases associated with grain dust, which could have serious consquences if they became established in Australia;
• maize presents a serious disease risk in relation to seed-borne diseases, and a lesser risk in relation to air-borne diseases;
• sorghum presents a serious disease risk in relation to seed-borne diseases, and a lesser risk in relation to air-borne diseases. The risk presented by sorghum can be mitigated to a large extent by sourcing grain from selected US states, where diseases are of low incidence or do not occur;
• barley from the USA presents a medium risk; and
• barley from Canada and Finland presents a very low risk, as all diseases associated with barley from these sources are present in Australia.

7.37 In September 1995, the AQIS Imported Grain Task Force released the Imported Grain Procedural Manual which establishes the conditions for the importation of grain and the procedures for managing the risks associated with it. The Imported Grain Procedural Manual covers only those grains on which Pest Risk Analyses have been performed. The manual was prepared in consultation with industries with interests in the importation of grain. The industries represented were:

• National Farmers' Federation;
• Grains Council of Australia;
• Flour Millers' Council of Australia;
• Petfood Industry Association of Australia;
• Australian Lot Feeders' Association;
• Australian Poultry Industries Association; and
• Pork Council of Australia.

7.39 The manual notes that after completing a PRA, AQIS arrives at a regulatory position which could range from unrestricted entry to total prohibition. In between, there are many other management options which might be used singly or in combination to reduce or eliminate the biological risks. These include sourcing from pest/disease free countries or parts of countries, chemical or physical treatments either abroad or on arrival, and inspection before shipment or on arrival. The manual was produced to assist importers, handlers and processors of grain to understand AQIS' quarantine approach to importing cereal grains.

7.40 Mr Paul Hickey described the risk management procedures prescribed by the Imported Grain Procedural Manual in the following terms:

The risk management procedures include issues to do with the sourcing of the grain; which states and which crops were of low or no risk in accordance with their pest and disease surveys; in the reliability of the security of the transport systems within the United States; in the reliability and security of the transport systems from the United States to Australia; and in the reliability and security of the handling arrangements at this end, which are now the subject of the separate trial that is proposed to be conducted.

7.41 The Committee received conflicting evidence from industry groups concerning the adequacy of the procedures in place to manage the risk of disease, pest and weed introduction through the importation of grain from North America.

7.42 This evidence related to the following matters:

• approach of AQIS to protocols;
• heat treatment of grain at port;
• specifications of transport vehicles;
• contingency plans for accidents; and
• consultation.

Approach of AQIS to Protocols

7.43 The Grains Council of Australia supported the importation of grain "as part of the necessary management of drought" and said that it had no fundamental objection to the transportation of grain "up-country". However, it was concerned that AQIS had not taken a conservative approach to managing the risks associated with the movement of grain.

7.44 The President of the GCA, Mr Ian Macfarlane, stated that the grain industry had a "lack of confidence in the current risk management procedures and approaches" and described the development of quarantine protocols as "learn as we go". He claimed that in two separate cases the procedures implemented by AQIS to contain grain and dust during the transfer of imported grain to storage installations were inadequate. In both cases the requirements were upgraded after GCA inspections identified the problems, but Mr Macfarlane said:

I would suggest that, had we not been there, those installations would have gone ahead and received grain under the standards that were already in place, and they were obvious standards.

7.45 In contrast, evidence from the Australian Lot Feeders' Association (ALFA) maintained that the procedures for managing the risk associated with imported grain had been developed after an exhaustive period of scientific research and practical trials. ALFA strongly disputed the GCA's claim that the approach to managing the risks of imported grain had not been sufficiently conservative. Mr Robin Coombs, ALFA Policy Consultant, remarked:

There has been a very long and detailed process of consultation between AQIS and various groups which we have documented in our submission. It has been, I think, a very good example of the complexities involved in disease risk assessment which is all about measuring risk and benefit. I would argue that the documentation to date would probably be the most rigorous, thoroughly research and analysed quarantine document that AQIS have been involved with. I think that would be a fair statement.

7.46 In support of this contention, ALFA provided the Committee with the following information, summarising the development of the import protocol process:

• on 26 October 1994, ALFA commissioned Mr David Heinrich of Techway to develop import procedures for the movement of grain to feedlots in country areas of Queensland and NSW. The procedures he developed included recommended modifications for the use of feedlots and other grain end users;
• ALFA quarantine procedures presented to AQIS' Imported Grains Task Force on 18 November 1994;
• AQIS required procedures to be tested to ensure that both grain spillage and dust could be controlled;
• Mr Heinrich was commissioned to act as project manager for a commercial trial on 28 and 29 November 1994 at the Whyalla feedlot to test the ALFA quarantine procedures, and modifications were made to the equipment at the feedlot and subsequently to the procedures in the light of the trial results;
• BRS presented its Pest Risk Analysis on 8 December 1994, stating that the rural delivery protocol would pose an acceptable risk if there were a guarantee of no spillage and no dust release;
• a second trial was conducted on 15 December 1994, involving the movement of 25 tonnes of barley from the Fisherman Islands grain terminal to the Whyalla feedlot;
• a study tour of US grain handling and inspection systems was made by representatives from the BRS, ALFA, GCA, AQIS and the Australian embassy;
• on 28 March 1995 a delegation of grain end users met with the Minister for Primary Industries and Energy seeking approval to trial procedures in the unreleased AQIS manual;
• the methodologies of trial design and outcome assessment have been agreed in discussions involving AQIS, grain end user groups and National Farmers Federation affiliated bodies, including the GCA; and
• trials are scheduled to be carried out later this year at feedlots to test the technical protocols agreed to date.

7.47 ALFA concluded that, in its view, "AQIS has bent over backwards to ensure that every possible pest and disease risk is understood before a final decision on up-country movement of grain is finalised ... in fact, AQIS has taken a very cautious approach".

Heat Treatment at Port

7.48 The GCA expressed concern that the protocols do not require imported grain to be heat treated at port. The Council expressed the view that heat treatment would eliminate the pest and disease risks associated with grain imports.

7.48 ALFA drew the Committee's attention to "considerable problems in heat treating grain at seaboard". ALFA stated:

Imported corn has recently been delivered to feedlots containing up to 18 per cent cracked grain, following heat treatment and cooling. When re steamed, this cracked grain turns to a "porridge" consistency. Consequently the cracked grain must be removed. In the steam flaking method of grain preparation for feedlot use, steaming must occur immediately prior to rolling and unless this process is completed, very poor utilisation of grain by the cattle occurs. In addition, a number of major feed lots utilise the Reconstitution Processing Technique. Heat treatment prior to this process destroys the ability to carry out this process.

Specification of Transport Vehicles

7.50 The GCA also expressed concern that the proposed transportation of grain in double tarpaulined trucks is not failsafe. The Council stated:

We have reserved our judgement on the effectiveness of moving grain in double tarped aluminium trailers, although our historical experience is that when one of those crashes, and they do crash, and just about every grain farmer will know of the consequences of that - they blow open like a can.

7.51 The Council concluded that imported grain being transported up-country should be carried in pneumatic steel containers, similar to those used by the flour and cement industries.

7.52 ALFA argued that the risk of a grain truck rolling had been exaggerated by the GCA, and that the issue of safe transportation of grain had been considered in detail by AQIS. The ALFA submission stated:

There is no record of double tarped trucks, (which is a commercially abnormal tarping procedure), having ever experienced a rollover in this country and, even if this had happened, the claim that they would "blow open like a can" is contrary to all practical knowledge. In fact, it is more likely that a sealed metal tanker type truck loaded with grain would "blow open like a can", than a double tarped truck.

Contingency Plans for Accidents

7.53 Mr Ian Macfarlane, President of the Grains Council of Australia, expressed strong concerns about the possible spread of disease or pests if a transport vehicle crashed. He stated:

You have to bear in mind the risks that will occur if a truck were to roll over. These trucks travel over watercourses which flow all the way through central Australia to the Bass Strait ... If the grain were lost into a table drain that was then subjected to a heavy downpour, there is also the risk that grain would be moved off-site or weed seeds would be moved off-site - and therefore out of the follow up inspection of that site by the AQIS authorities - to germinate somewhere where it is not under anyone's supervision.

7.54 ALFA disputed the evidence of the Grains Council, advising the Committee that the draft protocol provides for very stringent route notification, convoy adherence, spill notification and clean up provisions.

Consultation

7.55 The GCA told the Committee that during the development of the Imported Grains Procedural Manual the grains industry had been consulted extensively. However, they expressed concern that they had not been consulted initially about specific shipments of imported grain. The GCA stated that, in that instance:

[W]e were less than happy with the procedures that were put in place there, and that led to the lack of confidence in our community about the procedures, especially when a lot of observers saw dust billowing from the plant. One does not necessarily associate physical dust with risk, but nevertheless the perception is there, and that needs to be dealt with.

7.56 In contrast, ALFA commented favourably on the exhaustive consultation process undertaken by AQIS.

Current Status

7.57 AQIS is undertaking trials in order to test and develop arrangements for the possible shipment of low risk grains into rural areas using double tarped tipper style trucks carrying domestic grain. The trial is being supervised by an industry-led Assessment Panel.

7.58 The trial started on 22 January 1996 and involved the handling and processing of 10 000 tonnes of domestic grain. The Committee understands that the trial was suspended on 1 February 1996 after the loss of four or five husks at Beef City, after the successful unloading of 500 tonnes.

Cooked Chicken Meat

7.59 Australia has had strict quarantine restrictions on the importation of poultry and poultry products, until recently allowing the importation of canned poultry products only. Currently, cooked uncanned poultry meat from New Zealand, which has a similar avian disease status to Australia, is permitted entry, but importation from other countries is not permitted. Uncooked chicken meat is not allowed from any country.

7.60 AQIS commenced an analysis of the risks associated with the importation of cooked and uncooked chicken meat from the USA, Denmark and Thailand in response to requests from these governments for access to the Australian market.

7.61 Dr Sarah Kahn, Assistant Director, AQIS Quarantine (Animal) Policy Branch, described the development of the risk assessment in the following terms:

We initially started looking at chicken meat imports, both cooked and uncooked, in 1990. A discussion paper was published in 1991 which talked about both cooked and uncooked chicken meat. Comment was sought on that paper and a large number of submissions were received. In the light of those submissions, after further considerations of technical issues, AQIS decided to proceed with an assessment of cooked chicken meat first and to leave the uncooked product to a later date, because the issues were less complex in looking at cooked chicken meat as opposed to uncooked.

7.62 The AQIS risk assessment identified two avian diseases as being of significant quarantine concern. These diseases are:

• Newcastle Disease: a highly infectious and contagious disease exotic to Australia; and
• Infectious Bursal Disease: the virus occurs in Australia, but highly virulent variant strains reported in the USA, Europe and Asia are exotic to Australia.

7.63 The risk assessment also examined seven other diseases, namely duck virus hepatitis, duck virus enteritis, equine encephalomyelitides, mycoplasma, Marek's disease, S. Enteritidis and avian influenza, but concluded that these were of negligible quarantine significance.

7.64 The AQIS Position Paper on the importation of cooked chicken meat from the USA, Thailand and Denmark concluded that, subject to specified risk reduction measures, the quarantine ban on importation should be lifted.

7.65 AQIS judged the risk of introduction of the avian diseases of concern to be acceptably low upon consideration of the following three factors:

• the nature of the original product;
• the effects of processing; and
• the proposed use of the product.

Nature of the Original Product

7.66 The draft conditions for the importation of cooked chicken meat specify that the chickens must originate from the country of export, and that the product is derived from clinically healthy chickens subjected to ante mortem and post mortem inspection under the supervision of the veterinary authority.

Effects of Processing

7.67 AQIS considers that the risk of disease introduction is further reduced by the processing requirements specified in the draft conditions. These requirements are:

• only de-boned cooked chicken meat is permitted for importation;
• cooked chicken meat and products must be processed in an establishment which conforms to construction, facilities and practices standards equivalent to that specified in the Australian Government publication, "Construction and Equipment Guidelines for Export Meat";
• cooked chicken meat and products must have been derived from poultry processed in premises under the supervision of the veterinary authority of the country of export;
• cooked chicken meat and products must not contain microbiological agents or residues injurious to human health. Approval for importation shall be subjected to AQIS' assessment of the exporting country's microbiological and residues monitoring programs; and
• chicken meat has been cooked to specified temperatures for a specified length of time.

7.68 Dr Kahn summarised the responses to the processing requirements proposed by AQIS from State departments of agriculture, the CSIRO, academia and industry organisations in the following terms:

[B]asically they accepted the technical argument that AQIS had proposed in terms of the efficacy of the cooking treatment to inactivate the viruses of concern. We had looked at infectious bursal disease virus and tried to identify a treatment that would be adequate, even for that very heat resistant virus. We had confidence that that virus would be inactivated by the cooking and we had a many times higher degree of confidence in relation to Newcastle Disease virus, because that is a much less resistant virus. So if you like we had a much higher level of confidence again that Newcastle Disease virus would not survive the cooking.

Proposed Use of the Product

7.69 Finally, even if a breakdown in the processing occurs, and viable pathogens remain in the product, AQIS considers that imported cooked chicken meat intended for human consumption is unlikely to come into contact with susceptible animals in quantities sufficient to result in infection. Dr Kahn expanded on this point as follows:

[T]he primary means of disease transmission with these diseases is bird-to-bird transmission. The experience overseas is that it spreads from live bird to live bird. That is the primary means ... For the introduction of disease to occur into commercial poultry in Australia, for example, those birds have to be put into contact with live virus and the virus infects them and establishes. So it is certainly a much longer and less clear pathway where you are importing products for human consumption that are going to go through the normal commercial distribution channels. You have to really start arguing the lower probability that scraps or discarded product is somehow going to be fed to commercial birds. We would certainly regard that as a lower risk scenario.

Industry Concerns

7.70 The Australian Chicken Growers' Council (ACGC) challenged the conclusion of AQIS' draft risk assessment on the importation of cooked chicken meat on two counts. First, the ACGC expressed doubt about the efficacy of the heat treatment proposed by AQIS to inactivate the pathogens.

7.71 According to the ACGC, AQIS' Position Paper refers to unpublished data from Dr D. Alexander of the Central Veterinary Laboratory, Weybridge, UK, which measures the heat resistance of one strain of infectious bursal disease virus (IBD) in one type of chicken preparation. The ACGC states that on the basis of this data, AQIS has determined the cooking conditions required for quarantine purposes for all strains of the IBD virus in all chicken meat products. According to the ACGC, "this approach is not supported by Dr Alexander and is in conflict with scientific thinking on heat sterilisation processes".

7.72 The ACGC also claimed that:

[I]t seems that AQIS has misused Dr Alexander's heat resistance data. This misuse would result in the cooking treatments having less sterilising effect than that calculated so the risk of viral particles surviving the cooking treatments would be larger than thought by AQIS.

7.73 In response to these concerns about the adequacy of the scientific data upon which the heat treatment requirements have been set, Dr Sarah Kahn observed:

Certainly, there is some scientific discussion as to whether there could be additional extra strains of virus that we are not yet aware of but which, perhaps, are more resistant than the strains that we are aware of and on which the research is being done. That is an imponderable question. It is always theoretically possible that there could be other strains of viruses that exhibit slightly different characteristics. But, on the basis of the information available to us, and bearing in mind that - as I said before - it was generally agreed that the heat treatment parameter would be sufficient to deal with both of these viral diseases, AQIS is now taking the proposed position that it has, which is that importation could safely be permitted.

7.74 Dr Kahn also pointed out that the heat treatments specified by AQIS would result in a "very well-cooked product". She continued:

[I]t is quite unprecedented in commercial terms. The governments of the US and Thailand complained that we were perhaps being overly stringent. They drew our attention to the fact that the international animal health organisation prescribes no such stringent cooking requirement, which we acknowledge. There is not an international standard for cooking, but we have nonetheless stood by the proposed standard, on the grounds that - on the information available to us - that was supportable on scientific grounds.

7.75 The second aspect of AQIS' draft risk assessment disputed by the ACGC is in relation to whether the heat treatment will be adequately performed by the exporting countries. Mr Peter Board, a consultant representing the ACGC, expressed his concerns in the following terms:

AQIS has a perilous trust in overseas processors and inspectors because what they are suggesting in their protocol is that they will require overseas processors and overseas inspection authorities to see that the heat sterilisation processes are properly applied to the product that will be imported into Australia. In other words, we are handing over the protection of Australia's quarantine status to people who have no real interest in the safety of our industry.

7.76 In response to this concern, AQIS advised that a part of its risk assessment process is an assessment of the adequacy of the veterinary services in an exporting country "from the point of view of disease control, reliability of reporting disease, capability to deal with disease and put appropriate health programs into place". In the cases of the USA and Denmark, AQIS said that it had a close working relationship with the relevant authorities there and a high degree of confidence in their certification. In the case of Thailand, Dr Kahn advised that "we have less developed knowledge of how the services operate". She continued:

Our view was that before proceeding to finalise the assessment on Thailand we should make a specific purpose visit and inspect and investigate any of the plants which the Thai authorities would nominate to us as being approved for the export of chicken meat ...[G]iven the concerns that have been raised by industry, ... the Chicken Growers Council has been advised that they would be invited to participate in an initial review of Thai plants and also that the Australian Veterinary Association could send a representative along as well. The feeling from AQIS is that for industry they probably need to see it with their own eyes to be really convinced.

7.77 Mr Hickey, AQIS' Executive Director, added:

This sort of process is entirely understood and acceptable in international trading terms. Each country has the opportunity, if it wishes, to satisfy itself about the processing systems in the exporting country. That is understood and recognised and acknowledged between quarantine authorities in those countries.

Relationship Between Trade and Quarantine Considerations in Risk Analysis

7.78 The relationship between trade and quarantine considerations is extremely complex, particularly in the light of the recent GATT SPS and TBT Agreements. The complexity of the relationship is encapsulated in AQIS' draft IRA on the importation of uncooked Pacific salmon, which states:

The favourable health status of Australia's animal populations supports internationally competitive agricultural and fisheries industries and is a key factor in ensuring continuing access to foreign markets for live animals including fish and their products. In order to protect the health status of animal (and plant) populations, Australia has adopted a conservative approach to quarantine decision making. As a net exporter of agricultural commodities, Australia must be increasingly conscious of the need to balance the imposition of restrictions on imports with the reasonable expectations of trading partners for access to Australia under commercially acceptable conditions.

7.79 Similarly, the introduction to the IRA on the importation of cooked chicken meat stated:

It is very much in Australia's interests to ensure that unjustified technical barriers are not put in the way of our exports. As a member of the GATT, Australia also has an obligation not to use quarantine as a non-tariff barrier to trade. Any restrictions placed on access to the Australian market must be based on grounds which will stand up to international scientific scrutiny.

7.80 Evidence from industry groups and the Tasmanian government were sceptical about whether AQIS made quarantine decisions purely on scientific grounds. For example, the Tasmanian Salmonid Growers Association argued that the bias it perceived in the draft IRA for Pacific salmon stemmed from Australia's commitment to free trade. Mr Owen Carington Smith, TSGA Chairman, stated:

There seems to be this underlying pressure all the way through. At the same time, there has been strong innuendo that our industry has been seeking trade protection. In our report we bring it right up front. We address the issues of whether or not we are seeking trade protection, and I think we very convincingly show that it is not.

7.81 In a similar vein, Dr Roger Hall, Senior Management Officer (Marine Farming), Tasmanian Department of Primary Industry and Fisheries (TDPIF) remarked:

[W]e now see some mixed messages coming out about what issues can properly be taken into account, particularly whether or not trade implications should be taken into account when making quarantine decisions. Clearly, when the Canadian salmon report came out it was made very clear by AQIS that trade implications were not to be used as a justification for quarantine decisions ... It is interesting that, as a result of a subsequent report on aquatic animal quarantine, which was commissioned back in 1992, people are now exhorted to consider carefully the trade implications before they make their quarantine decisions.

7.82 The TDPIF maintained that this blurring of the distinction between trade and quarantine considerations placed AQIS in an invidious position, making it "judge, jury and executioner in determining and delivering quarantine policy". Dr Hall suggested:

[I]t may be that the time has come for quarantine policy to be formulated by a group which involves industries who are directly involved in the outcome of these decisions, state governments, and Commonwealth agencies who are involved, and to separate that body, which would have to be constituted appropriately to deal with any given issue, and leave AQIS to deliver the programs uninterrupted, or as a separate matter.

7.83 The Tasmanian Farmers and Graziers Association (TFGA) made a similar point, arguing that AQIS has difficulty maintaining its role as an independent scientist while balancing the political expectations of the marketplace and government. The TFGA also proposed that a separate trade quarantine and policy council be established, whose role would be to decide "the pragmatic directions of trade decision on the technical advice that comes to them from AQIS and the issues of trade barter, as it were, that come to them from other sources". Mr Malcolm Cleland, a consultant with the TFGA, maintained:

[T]he role of government and the role of AQIS are too muddied. AQIS, rather than staying with pure science and saying, "Okay, clearly that is an exotic pathogen that has come to the state, we must find out about it and then make the decision", has also been a sort of judge for the government as well and has had to watch other issues, such as whether it is or is not politically appropriate to make the necessary decisions. I think this compromise is constantly taking place between AQIS's role as a scientist and the roles of government in the broader sense.

7.84 In summary, the TFGA argued that trade policy issues "should be transparent and put into another forum where there is more transparency".

7.85 The Committee asked the Executive Director of AQIS whether there was any pressure on AQIS to moderate quarantine decisions so that Australia is not perceived internationally as applying non-tariff trade barriers through illegitimate quarantine restrictions. Mr Hickey responded categorically:

We do not reflect broader trade considerations in the assessment we make about individual products. We do that based specifically on the technical and scientific aspects of pests and the diseases associated with the product that is proposed to be imported. Generally speaking, in broader trade terms outside of AQIS' responsibilities - this relates to the broader department of primary industries and DFAT [Department of Foreign Affairs and Trade] - Australia is regarded internationally as having an extremely conservative quarantine stance, and that is unashamably the case ... So we are required to conduct our assessments having regard to that conservative stance but, when it comes to the actual decision making processes, the broader economic or trade aspects, apart from the economics of the possible introduction of a disease, are not taken into account by AQIS.

CHAPTER 8

RISK ANALYSIS AND RISK MANAGEMENT - CONCLUSIONS

Conclusions

8.1 The Committee endorses the risk analysis and management approach applied by AQIS, and in so doing notes the following:

• risk assessment and risk management are scientific, in the sense that valid reasons based on scientific information can be given for the allocation of resources in particular areas or for assessments of levels of risk; and
• risk assessments and risk management are not, and cannot be, purely objective in the sense that all persons with the same information will necessarily come to the same conclusions.

8.2 This Committee is concerned about the persistence of the view that "no risk" is a viable option for quarantine policy, despite consistent and unequivocal dismissal of this approach by previous reviews. The Committee is of the view that a no risk approach is unrealistic and untenable, and that its currency only demonstrates that the concepts of acceptable risk or risk management are widely misunderstood.

8.3 The Committee recommends that AQIS develop strategies to better explain and disseminate information on its risk analysis and management approach to quarantine and inspection.

8.4 The Committee examined in detail the application of risk analysis principles to the proposed importation of uncooked Pacific salmon, grain and cooked chicken meat. The three case studies illustrate the complexity of the risk analysis process and the extent to which judgements about the level of risk can be the subject of genuine dispute.

8.5 The Committee also acknowledges that AQIS sometimes undertakes its risk analysis in a highly charged environment, since their decisions may have significant implications for various interested parties.

8.6 The Committee considers that it would be inappropriate for it to adjudicate on the scientific issues involved in the three case studies. Nevertheless, the Committee is of the view that, if the risk assessment process is to retain its integrity and independence, AQIS must:

• have access to scientific and technical expertise;
• consult fully with relevant industries, and use industry's practical experience; and
• base quarantine decisions on scientific grounds, and not trade related considerations.

Access to Scientific and Technical Expertise

8.7 The Committee notes the assurance of the Executive Director of AQIS, Mr Paul Hickey, that AQIS possesses or has access to the expertise required to undertake comprehensive risk assessments. Mr Hickey stated:

I am more than confident that we have the foundations and the technical expertise on hand to cater for our current and immediately projected workloads. In addition to that we commission the BRS regularly to undertake specialist scientific work on our behalf and we recruit on a contract or consultancy basis people from CSIRO or universities to add to those resources as necessary. I am never going to deny the fact that our people are under pressure and work enormously hard, and that is something that we have got to continually keep an eye on. But for the moment we have the sorts of mechanisms in place, and we have certainly got the resources, to enable us to carry on the technical side of our business.

8.8 Although these assurances are welcome, the Committee also notes evidence questioning the technical and scientific expertise of AQIS.

8.9 The Committee recommends that the Minister for Primary Industries and Energy, recognising that scientific and technical expertise must increasingly underpin the operations of AQIS particularly in quarantine, undertake a review of AQIS' resources and capacities and, if necessary, increase staffing and resources.

8.10 The Committee is concerned that the scientific research on the basis of which AQIS must make an assessment of risk should be comprehensive and relevant to Australian conditions. The Committee recommends that assessments of risk should not be made until such research has been done.

Consultation

8.11AQIS advised that it receives external input into a draft risk analysis during at least two different stages in its development. The initial draft is "generally the product of more input than simply internal AQIS work". Dr Sarah Kahn noted:

[W]hen we are developing the draft, we consult with the veterinarians in the department in the foreign diseases area and in the Bureau of Resource Sciences ... Also, if it is a major policy review or a significant new determination, quite a number of those draft papers are prepared through working parties where we draw in people from the States, academia and CSIRO, and actually prepare a working paper which is the sum input from all of those different scientists.

8.12 This initial draft is then released for public comment from organisations such as the CSIRO, BRS and universities, and from technical experts employed by industry. Mr Hickey remarked:

It ensures that we get the full range of issues put before us and that concerns are identified and we have the opportunity to go through those in great detail. It carries a lot of benefits from our perspective.

8.13 The Committee, however, was concerned that the standard practice of consulting industry after the development of an initial risk assessment might be unsatisfactory in two respects. First, the initial draft might contain inaccuracies which could be easily avoided by wider consultation during the development of the draft IRA. Secondly, the release of a draft document that has not involved prior input from the industry may lead to expensive and acrimonious disputes. Such a process seems to expose the credibility and scientific expertise of AQIS to avoidable criticism.

8.14 The Committee considers that the disadvantages of the current consultative arrangements are illustrated by the debate over the draft IRA on uncooked Pacific salmon. For example, the Committee finds it difficult to understand why AQIS did not inspect and have extensive discussions with the salmon industry in Tasmania. The Committee considers that this course of action would have been preferable to what has now become a protracted, acrimonious and seemingly inefficient process.

8.15 The Committee questioned AQIS on this issue, and asked whether it might be more effective to engage in wide-ranging consultation prior to issuing a draft assessment. Mr Digby Gascoine, Director, Development and Evaluation Division, responded:

[T]he process of preparing a draft import risk analysis also has the benefit of allowing people who are interested in it - scientists, but also industries and so on - to get an idea about where we might be headed in consideration of the proposal, and that enables them to better focus the comments that they might want to make to us, or the questions that they want to raise of a technical nature.

8.16 The Committee does not accept this explanation.

8.17 The Committee recommends that AQIS should have wide-ranging consultations with relevant industry groups before publishing a draft IRA. The Committee considers that such an approach will protect the integrity of AQIS' scientific reputation, reduce the likelihood of protracted and acrimonious debates, and ensure stable investment environments in the relevant industries.

Quarantine vs Trade Considerations

8.18 The Committee welcomes AQIS' assurance that trade considerations do not affect its quarantine decision making process. However, the Committee also notes the significant concerns expressed by the Tasmanian Department of Primary Industry and Fisheries and other organisations that the distinction between quarantine and trade considerations is becoming blurred.