Director of Animal and Plant Quarantine v Australian Pork Limited [2005] FCAFC 206 (16 September 2005)

Last Updated: 16 September 2005

FEDERAL COURT OF AUSTRALIA

Director of Animal and Plant Quarantine v Australian Pork Limited

[2005] FCAFC 206

QUARANTINE – permit granted to import pig meat from United States – requirement to consider ‘level of quarantine risk’ and conditions to limit risk to ‘acceptably low’ level – decision to grant permit based on a report of a panel of experts – whether panel’s findings constitute Wednesbury unreasonableness – whether decision to grant permit invalid because it had regard to ‘generic considerations’ – whether decision-maker complied with mandatory statutory obligations.

Acts Interpretation Act 1901 (Cth) s 46
Administrative Decisions (Judicial Review) Act 1977 (Cth)
Federal Court of Australia Act 1976 (Cth) s 23
Judiciary Act 1903 (Cth) s 39B
Quarantine Act 1908 (Cth) ss 4(1), 5, 5D, 8B(1), 9AA(1), 10B, 13, 52A, 53
Quarantine Amendment Act 1999 (Cth) ss 60, 210, 211

Quarantine Proclamation 1998 (Cth) ss 39(1), 70

Associated Provincial Picture Houses Ltd v Wednesbury Corporation [1947] EWCA Civ 1; [1948] 1 KB 223 applied
Australian Broadcasting Corporation v Lenah Game Meats Pty Ltd [2001] HCA 63; (2001) 208 CLR 199 cited
Australian Broadcasting Tribunal v Bond [1990] HCA 33; (1990) 170 CLR 321 cited
Australian Pork Ltd v Director of Animal and Plant Quarantine [2005] FCA 671 overruled
Chan v Minister for Immigration and Ethnic Affairs [1989] HCA 62; (1989) 169 CLR 379 followed
House v The King [1936] HCA 40; (1936) 55 CLR 499 cited
Minister for Immigration and Multicultural Affairs v Eshetu [1999] HCA 21; (1999) 197 CLR 611 followed
Minister for Immigration and Ethnic Affairs v Wu Shan Liang [1996] HCA 6; (1996) 185 CLR 259 cited
Mohammed v Minister for Immigration and Multicultural Affairs [2000] FCA 264 cited
Parramatta City Council v Pestell [1972] HCA 59; (1972) 128 CLR 305 cited
Puhlhofer v Hillingdon London Borough Council [1986] UKHL 1; [1986] AC 484 cited

World Trade Organisation Agreement on the Application of Sanitary and Phytosanitary Measures


DIRECTOR OF ANIMAL AND PLANT QUARANTINE v AUSTRALIAN PORK LIMITED, WINDRIDGE FARMS PTY LIMITED AND FAYMAN INTERNATIONAL PTY LIMITED (ACN 002 797 079)

NSD 994 of 2005

HEEREY, BRANSON & LANDER JJ
16 SEPTEMBER 2005
SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY	NSD 994 of 2005

ON APPEAL FROM A JUDGE OF THE FEDERAL COURT OF AUSTRALIA

BETWEEN:	DIRECTOR OF ANIMAL AND PLANT QUARANTINE APPELLANT
AND:	AUSTRALIAN PORK LIMITED FIRST RESPONDENT WINDRIDGE FARMS PTY LIMITED SECOND RESPONDENT FAYMAN INTERNATIONAL PTY LIMITED (ACN 002 797 079) THIRD RESPONDENT
JUDGES:	HEEREY, BRANSON & LANDER JJ
DATE OF ORDER:	16 SEPTEMBER 2005
WHERE MADE:	SYDNEY

THE COURT ORDERS THAT:

1. The appeal be allowed.
2. The declarations and orders made by the primary judge be set aside and in lieu thereof the application be dismissed with costs.
3. The first respondent pay the appellant’s costs of the appeal.

IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY	NSD 994 of 2005

ON APPEAL FROM A JUDGE OF THE FEDERAL COURT OF AUSTRALIA

BETWEEN:	DIRECTOR OF ANIMAL AND PLANT QUARANTINE APPELLANT
AND:	AUSTRALIAN PORK LIMITED FIRST RESPONDENT WINDRIDGE FARMS PTY LIMITED SECOND RESPONDENT FAYMAN INTERNATIONAL PTY LIMITED (ACN 002 797 079) THIRD RESPONDENT
JUDGES:	HEEREY, BRANSON & LANDER JJ
DATE OF ORDER:	16 SEPTEMBER 2005
WHERE MADE:	SYDNEY

REASONS FOR JUDGMENT

HEEREY AND LANDER JJ

1 On 30 July 2004 a delegate of the Director of Animal and Plant Quarantine (‘the Director’) granted a permit (‘the Permit’) for the import of pig meat from the United States for a period of two years from that date. Legislation required the Director to consider the ‘level of quarantine risk’ and what conditions would be necessary to limit the level of that risk to one that was ‘acceptably low’. ‘Quarantine risk’ means the probability of a disease being introduced, established or spread in Australia and causing harm and the probable extent of that harm.

2 One of the matters the delegate took into account in deciding to grant the Permit was a Policy Determination (‘the Determination’) made on 10 May 2004 by the Director which accepted the recommendation of an Import Risk Analysis Report (‘the IRA Report’) made by a panel of scientific experts (‘the Panel’). The Panel had assessed the quarantine risk for the importation of pig meat, and conditions which might limit that risk, in relation to a number of diseases found in pigs. One of these diseases was post-weaning multisystemic wasting syndrome (‘PMWS’).

3 The learned primary judge (Wilcox J) on 27 May 2005 upheld a challenge to the validity of the Determination and the Permit made under the Administrative Decisions (Judicial Review) Act 1977 (Cth) (‘the ADJR Act’): Australian Pork Ltd v Director of Animal and Plant Quarantine [2005] FCA 671. His Honour heard much scientific evidence, some of it conflicting. While critical of much of the reasoning process and methodology of the Panel, his Honour upheld the argument for invalidity as a matter of law on only one point. His Honour found that the part of the Panel’s reasoning which considered the appropriate measures for the reduction of quarantine risk in respect of PMWS to an acceptably low level made the IRA Report, in terms of the ADJR Act, so unreasonable that no reasonable decision-maker could make it. As a consequence, the Determination and the Permit were invalid.

4 In our view, there was no legal invalidity in the process, including the IRA Report and the Determination, which led up to the decision to grant the Permit. That process involved fact finding and the making of value judgements and risk assessments in a complex scientific setting. The good faith and scientific competence of those engaged in the task is not in question. While there is room for debate as to some aspects of the IRA Report, the Panel did not carry out its task irrationally or unreasonably. The Court is not empowered to adjudicate on the factual correctness or otherwise of the IRA Report.

5 Another argument was raised. It was said that the decision to grant the Permit itself was invalid because the delegate only had regard to the ‘generic’ considerations of the IRA Report. The legislation required consideration of the statutory factors on a permit by permit basis. We agree with the latter proposition. However, that is in fact what happened. As will appear in more detail below, the delegate had detailed information about relevant conditions in the United States and took these into account in the formulation of conditions in the Permit.

6 The appellant is the Director. The first respondent is Australian Pork Limited (‘APL’), a company formed by Australian pig farmers to represent their interests, including in their relations with governments. The second respondent, Windridge Farms Pty Ltd, owns and operates a number of pig farms near Young, New South Wales. The third respondent, Fayman International Pty Ltd (‘Fayman’), the company to which the Permit was granted, was a respondent in the proceeding at first instance. APL was the only respondent to appear on the hearing of the appeal.

THE LEGISLATION

7 Section 4(1) the Quarantine Act 1908 (Cth) (‘the Act’) states:

‘(1) In this Act, quarantine includes, but is not limited to, measures:

(a) for, or in relation to:
(i) the examination, exclusion, detention, observation, segregation, isolation, protection, treatment and regulation of vessels, installations, human beings, animals, plants or other goods or things; or
(ii) the seizure and destruction of animals, plants or other goods or things; or
(iii) the destruction of premises comprising buildings or other structures when treatment of these premises is not practicable; and
(b) having as their object the prevention or control of the introduction, establishment or spread of diseases or pests that will or could cause significant damage to human beings, animals, plants, other aspects of the environment or economic, activities.’

8 Section 39(1) of the Quarantine Proclamation 1998 (Cth) (‘the Proclamation’), made by the Governor-General pursuant to s 13 of the Act, provides:

‘The importation into Australia of meat or a meat product is prohibited unless a Director of Quarantine has granted a permit to import the meat or meat product into Australia.’

9 Section 13(2B) of the Act provides that such a permit ‘may be granted subject to compliance with conditions or requirements set out in the permit’.

10 Section 70 of the Proclamation stipulates the matters that the Director must take into account in deciding whether to grant an import permit. Relevantly, the Director:

‘...

(a) must consider the level of quarantine risk if the permit were granted; and
(b) must consider whether, if the permit were granted, the imposition of conditions on it would be necessary to limit the level of quarantine risk to one that is acceptably low; and
(c) may take into account anything else that he or she knows that is relevant.’

11 The term ‘level of quarantine risk’ is defined in s 5D of the Act:

‘A reference in this Act to a ‘level of quarantine risk’ is a reference to:

(a) the probability of:
(i) a disease or pest being introduced, established or spread in Australia, the Cocos Islands or Christmas Island; and
(ii) the disease or pest causing harm to human beings, animals, plants, other aspects of the environment, or economic activities; and
(b) the probable extent of the harm.’

12 Sections 4 and 5D in their present form were inserted into the Act by the Quarantine Amendment Act 1999 (Cth). This amending legislation emphasised the centrality of risk to Australia’s quarantine regime. The Explanatory Memorandum to the Bill for the amending legislation stated (at 2):

‘Australia’s quarantine policy is based on the concept of the management of risk to an acceptably low level. The natural and economic movement of people, animals, plants and goods results in an inevitable quarantine risk to Australia. Australia’s approach is to manage risk in a manner that provides appropriate protection for Australia, is based on scientific reasoning and is consistent with international rules and standards.’

13 Australia has international obligations arising under the World Trade Organisation Agreement on the Application of Sanitary and Phytosanitary Measures (‘the SPS Agreement’). The SPS Agreement allows member states to determine their ‘appropriate level of sanitary or phytosanitary protection’ (‘ALOP’) which it defines as:

‘the level of protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory.’

14 The Import Risk Analysis Handbook, which was in evidence before the primary judge, states:

‘Like many other countries, Australia expresses its ALOP in qualitative terms. Australia’s ALOP, which reflects community expectations through government policy, is currently expressed as providing a high level of sanitary or phytosanitary protection aimed at reducing the risk to a very low level, but not to zero.’

PMWS

15 Section 5 of the Act defines quarantinable disease as ‘any disease declared by the Governor-General, by proclamation, to be a quarantinable disease’. PMWS has been proclaimed a quarantinable disease.

16 PMWS occurs mainly in weaner pigs between 6 and 12 weeks of age, and affects several organ systems. In a newly affected herd, between 4 and 20 per cent are likely to be affected and 70 to 80 per cent of affected pigs usually die.

17 PMWS has been detected in most countries, including Canada and Denmark. The primary judge quoted (at [16]) the evidence of Professor Roger Morris that ‘Australia stands out among significant pig-raising countries in that it remains free when virtually all others have become infected over less than a decade’.

18 There is disagreement on the causes of PMWS. Professor Morris stated:

‘The most characteristic feature of PMWS, although not always present, is the occurrence of intensely basophilic inclusion bodies in many of the affected tissues that are rich in porcine circovirus (PCV) antigen and from which PCV can invariably be isolated.’

19 There are two forms of PCV. The form relevant to this case is PCV2, a form of the virus which, according to Professor Morris, ‘is ubiquitous in pig herds in all parts of the world examined, and it is rare to find a herd free of the virus’. PCV2 is present in Australia.

20 PCV2 is a necessary, but not sufficient, cause of PMWS. A co-factor, presently unidentified, is involved. It may be a new virus or a new, particularly virulent, strain of PCV2. Some scientists believe the co-factor is genetic or arises out of handling or environmental factors. Professor Morris disagreed with this view. His Honour accepted that this was a matter of ‘vigorous debate between well-qualified scientists’ and found that it was not necessary to form any view. As will be seen, the Panel adopted the technique of using a proxy or surrogate for the co-factor.

THE IRA REPORT

21 The Panel consisted of Dr David Banks, General Manager of Animal Biosecurity in Biosecurity Australia, Dr Robyn Martin, Manager of Animal Biosecurity in Biosecurity Australia, Dr Kevin Doyle, Veterinary Director of the Australian Veterinary Association, Dr Ross Cutler, Consultant Specialist Veterinarian and Professor Colin Wilks, Consultant Microbiologist. Two technical working groups, one of which was concerned with PMWS, assisted the Panel. The following summary of the contents of the IRA Report is largely based on his Honour’s judgment.

22 The IRA Report explained that, under existing policy, uncanned, uncooked pig meat could be imported only from the South Island of New Zealand, Canada and Denmark. The approximate proportion of imports from each of these sources was respectively 5, 60 and 35 per cent. Canadian and Danish pig meat had to be imported deboned and cooked on arrival in Australia. These requirements were imposed in order to address the quarantine risk associated with the potential presence of porcine reproductive and respiratory syndrome (‘PRRS’). Pig meat could be imported from any country if the meat was imported in a sealed container, the contents of which had been heated to at least 100deg.C.

23 Although the evidence and arguments are confined to the risk to Australian pigs from PMWS, it is important to note that the IRA Report also discusses the risk posed by 11 other diseases.

The risk estimation matrix

24 The IRA Report sets out, at Table 10 on p 14, a ‘risk estimation matrix’. It took the following form:

25 At p 24, in a section of the IRA Report explaining their adopted method of assessing import risk, the Panel said the assessment should take into account both ‘the likelihood that a pathogenic agent will enter an importing country’ (‘release assessment’) and ‘the likelihood that susceptible animals will be exposed to that agent’ (‘exposure assessment’). In the context of PMWS, ‘susceptible animals’ means healthy pigs. PMWS has not been found in humans or in other animal species. The likelihood of establishment and spread, and the biological and economic consequences of introducing a pathogenic agent were to be determined through a ‘consequence assessment’. The Panel said:

‘The risk assessment for each identified agent concluded with "risk estimation", the combination of the likelihoods and consequences, and yielded the unrestricted risk estimate.’

26 The ‘unrestricted risk’ is the risk that exists before the application of conditions designed to reduce the risk level. The risk after application of recommended conditions is termed ‘restricted risk’.

27 At p 27 the Panel said: ‘Quantitative data were not available to support many of the probabilities assigned to the pathway steps considered in this analysis’. ‘Likelihoods’ were therefore derived from ‘expert judgements’. If the likelihood was described as ‘high’, this meant ‘the event would be very likely to occur’. If it was ‘moderate’, this meant ‘the event would occur with an even probability’. If it was ‘low’, ‘the event would be unlikely to occur’. If it was ‘very low’, ‘the event would be very unlikely to occur’; and so on to ‘extremely low and negligible’.

Assessment of consequences

28 The consequences line has an important bearing on the risk matrix results. At p 63, the Panel stated that direct and indirect consequences were estimated at four levels: (local, district/regional, State/Territory and national). The first step was to assess the magnitude of the impact of the particular disease on the national economy or Australian community; if there was no discernible impact at that level, in descending order the magnitude of impact at other levels would be investigated.

29 In assessing consequences, the Panel addressed exposure to PMWS of three different groups of Australian pigs: feral pigs, backyard pigs and pigs in small commercial piggeries. The Panel had in mind the possibility that pigs in the latter two groups might be fed discarded pig meat scraps and that feral pigs might obtain them by scavenging at rubbish tips.

30 The Panel’s discussion of consequences, in relation to PMWS, commences at p 385 of the IRA Report. The technical information set out in the IRA Report includes a comment that ‘(i)ncreasing evidence continues to support the hypothesis that PCV2 is essential for the development of PMWS’. Consequently, the Panel paid some attention to transmission of the virus. At p 389, the Panel said it was unaware of any studies that have examined skeletal muscle for the presence of PCV2 viral antigen or virus. The Panel also said ‘(i)t is unknown if pigs can be infected orally with PCV2’. However, it said: ‘The detection of the virus in oronasal secretions and faeces is compatible with an oral route of transmission’.

31 Pages 390-391 contain a ‘release assessment’ in which the Panel referred to a series of potentialities and ascribed a likelihood to each. They were as follows:

R1 - ‘the likelihood that a source herd is infected’ – assessed as ‘moderate’;

R2 - ‘the likelihood that a slaughter-age pig from an infected herd is infected’ – assessed as ‘moderate’;

R3 - the likelihood of non-detection. The Panel thought the sensitivity of ante-mortem, slaughter and processing procedures in detecting and removing subclinically infected pigs was ‘extremely low’. In other words, there was an extremely high likelihood that any subclinical PMWS infection in imported carcasses would escape detection;

R4 - ‘the likelihood that the pathogenic agent will be present in the meat harvested for export’ – assessed as ‘moderate’;

R5 - ‘the likelihood that the pathogenic agent will not be destroyed by the post-mortem decrease in muscle pH that accompanies carcass maturation – assessed as ‘high’;

R6 - ‘the likelihood that the pathogenic agent will not be destroyed during cold storage and transport’ – assessed as ‘high’.

32 The Panel concluded:

‘When these likelihoods were inserted into the simulation model, it was concluded that, in the absence of risk management and without considerations regarding the exporting country, there was a "low" likelihood that imported pig meat derived from an individual carcass would be infected.’

Estimate of annual exposure

33 The Panel went on to consider annual exposure assessments (‘the L factor’) for each of the three groups of pigs. It is unnecessary to set out the components of each assessment. The Panel’s conclusion in respect of each group of pigs was that the overall annual likelihood of entry and exposure for that group was ‘high’.

Estimate of outbreak scenario likelihoods

34 The Panel then estimated the likelihood of each outbreak scenario. In its assessment there was a moderate likelihood of transmission of the disease from an exposed herd of feral pigs to a more general population of feral pigs and to backyard pigs but only a low likelihood of transmission to a more general population of domestic pigs, including pigs in medium-large piggeries. However, with infected backyard pigs there was a high likelihood of transmission to pigs in a more general population of pigs, and similarly, if the infection was in small commercial piggeries.

Estimate of impact of PMWS in various groups

35 In assessing the impact of an outbreak of PMWS in each of the three postulated groups, the Panel used letters (A to G) to indicate a rating. The earlier the alphabetical position of the letter, the less significance was to be ascribed to that effect. The significance to be ascribed to each of the letters depended on whether the assumed effect had consequences on a national, State/Territory, district/region or only local level. That appears from Table 8 of the IRA Report which is reproduced below:

36 The Panel concluded (at p 399) that an outbreak of PMWS that was confined to a directly exposed group of pigs would have only a B rating on animal health and an A rating on eradication programs and trade and industry (because the presence of the disease would be unlikely to be detected). However, if the disease spread to a local population of pigs in backyard or small commercial piggeries, the effect on animal health and domestic trade would be C, although the effect on international trade only B.

37 The scenario assessment relating to a possible secondary spread, via feral pigs or other means, to a more general population of domestic pigs, including medium-large commercial piggeries, was explained by the Panel at p 402:

‘Under this scenario, PMWS would have established in a broader population of commercial piggeries (including medium-large piggeries) and be identified. If the disease was not widespread in the Australian pig population, a control program may be implemented, alternatively, if widespread, control would likely be left to individual producers.’

38 The Panel noted high mortality rates in the United Kingdom, although they were apparently lower in Canada, the United States and Germany. The Panel said:

‘On balance, the direct impact on animal health was considered unlikely to be discernible at the national level, but would be of minor importance at the State level. This gave the disease a rating of "D" for this criterion.’

39 The effect on domestic trade was similarly assessed. No figures were mentioned. Nor did the Panel make any distinction between the possible effect of PMWS in one State or Territory, as compared with any other State or Territory; for example, because of differences in their pig populations. Table 8 allowed State/Territory effects (however serious) to be categorised only as ‘minor’ (impact score D) or ‘unlikely to be discernible’ (impact score C). Unlike the situation in relation to national effects, there was no option of classifying a State/Territory effect as ‘highly significant’ (impact score G) or ‘significant’ (impact score F).

40 In considering the indirect effect of a secondary spread of PMWS to a general population of domestic pigs, the Panel assigned a C to the impact on eradication, control and compensation strategies and a D to the effect on domestic trade or industry.

41 The Panel said that, when the direct and indirect impacts of PMWS in each scenario were combined, using the decision rules that it had adopted, the consequences ranged from ‘negligible’ to ‘low’. Combining these consequences with the assessed likelihoods, the overall likely consequences associated with the exposure of feral pigs to infected pig meat scraps were considered very low, and those for backyard pigs and pigs in small commercial piggeries were considered to be low.

42 This assessment was made on an annual basis; that is, there will be a ‘low’ risk to backyard pigs and pigs in small commercial piggeries in each year, not a low risk of infection overall. The Panel did not make any assessment of the degree of risk of infection over a longer period of time.

Recommendations for reduction of risk

43 A ‘low’ risk exceeds the ‘very low risk’ that is Australia’s ALOP. Consequently, in the concluding chapter of the IRA Report, the Panel discussed the options for further reducing the risk. At p 745 it said:

‘The likelihood that PMWS could enter, become established and/or spread in Australia via imported pig meat could, in theory be reduced by the application of some or all of the following measures:

• a requirement that the pigs of origin had never been in a PMWS infected country or zone since birth;
• a requirement that slaughter and processing ensured removal of organs and tissues which are sites of predilection for the virus;
• reduction in the volume of pig meat waste discarded in Australia.

As porcine circovirus has been reported to be stable at a temperature 70ºC for 15 minutes, the Panel did not examine the direct effect of processing (other than canning) on the destruction of this virus. Options were examined to identify the least trade restrictive measures which would reduce risks within Australia’s ALOP.’

44 In relation to canning, the Panel commented at p 745:

‘Australia currently accepts shelf stable canned pig meat from any source country subject to certain conditions. The Australian import conditions for canned meat include a requirement that all portions of the contents have been heated to at least 100ºC. Porcine circovirus has been reported to be stable at 70ºC for 15 minutes. The Panel considered that PCV2 would be inactivated in canned pig meat heated to at least 100ºC.’

45 The Panel at p 746 then turned to the possibility of modified dressing of the carcass:

‘The Panel examined removal of major peripheral lymph nodes (i.e. removing the head and neck and removal of other major peripheral lymph nodes such as inguinal, popliteal, axillary etc) together with deboning the carcass on the above likelihoods. The Panel considered that removal of the head and neck, including any remaining tonsillar tissue, and lymph nodes draining the pharynx, other major peripheral lymph nodes and deboning could reduce the likelihood assigned to R4 from "moderate" to "low".

Moreover, if meat is sourced from areas other than the head and neck and other major peripheral lymph nodes are removed together with bone, the amount of virus present in a waste unit would be reduced. It is known that the virus has a strong affinity for lymph nodes ... Virus titres of approximately 10⁵ to 10⁶ TCID₅₀/g of lymph node have been reported from clinically healthy pigs experimentally infected with PCV2 ... Levels of virus in both serum and lymph nodes decrease with increasing time post-infection. In persistently infected pigs levels of virus in tissues are likely to be low.

Given the likely level of virus in muscle per se, the composition of pig meat waste (bone-out) and the volume of waste consumed by a pig, it was considered that the likelihood assigned to L2 could be reduced from "moderate" to "very low".’

46 On the reduction in the volume of discarded waste, the Panel at p 746 expressed the view

‘that if meat was deboned and processed either by cooking or curing, the proportion of pig meat purchased by households and food service establishments that was discarded as waste would be reduced to one tenth of that estimated for the unrestricted risk.’

47 The Panel went on to express the opinion that a combination of removal of peripheral major lymph nodes, deboning and cooking or curing, would reduce the previously ‘low’ risk to ‘very low’ and thereby meet Australia’s ALOP. The Panel made the following comment (at p 747):

‘As PCV2 has been shown to result in persistent infections, has been isolated from many tissues, is a hardy virus and is likely to be transmitted orally, the Panel considered that if an unknown disease agent was involved in PMWS, the risk management measures requiring removal of bone, major peripheral lymph nodes, head and neck and cooking or curing would act to reduce the risks associated with that agent. Biosecurity Australia and the PMWS technical working group will continue to monitor the situation in response to new information that becomes available on the disease.’

THE JUDGMENT AT FIRST INSTANCE

48 APL and Windridge applied to the Court under the ADJR Act and s 39B of the Judiciary Act 1903 (Cth). The validity of the Determination and the Permit was challenged on four grounds:

(i) error of law;
(ii) failure to take into account a relevant consideration;
(iii) unreasonableness; and
(iv) no evidence.

49 His Honour held there was no error of law or failure to take into account a relevant consideration. Although his Honour criticised the Panel’s decision to limit their assessment of risk in the IRA Report to a 12 month period, his Honour did not think this decision reflected an error of law or a failure to consider a relevant circumstance. His Honour pointed out (at [293]) that s 70 of the Proclamation sets out only two matters which the Director is required to take into consideration when deciding whether to grant a permit under s 39: ‘the level of quarantine risk if the permit were granted’ and possible conditions and does not ‘require the Director to make, or adopt, a long-term policy intended to guide various decision-makers over an indefinite period of time.’ Although his Honour criticised the methodology adopted by the Panel; in particular, the Panel’s selection of bands of probability distribution, he did not think that amounted to an error of law or a failure to take into consideration a relevant circumstance. His Honour commented (at [294]):

‘It is not to the point, in relation to these grounds, that I have concluded there are significant problems about the quality of the recommendations’.

50 His Honour did, however, find that there was unreasonableness within the meaning of ss 5(2)(g) and 6(2)(g) of the ADJR Act, or ‘Wednesbury unreasonableness’ (see Associated Provincial Picture Houses Ltd v Wednesbury Corporation [1947] EWCA Civ 1; [1948] 1 KB 223, the source of this administrative law concept), in relation to the Panel’s reasoning on conversion of unrestricted risk to restricted risk. This step was critical to the result of the study and the Determination itself.

51 His Honour considered the crucial step in the reasoning of the Panel was expressed in the passage from the IRA Report already quoted at [47] above.

52 His Honour (at [273]) summarised the reasoning in this way:

‘...

(i) PCV2 has certain characteristics, including being present in many tissues and being a hardy virus;
(ii) Therefore, assuming an unknown infectious co-factor of PMWS, particular risk management measures ‘would act to reduce the risks associated with that agent.’

53 His Honour continued (at [274]):

‘274 There appears to be no connection between the first proposition and the second. It may readily be accepted, as Dr Allan stated at para 119 above, that the recommended risk management measures would have a tendency to reduce the risk posed by the assumed PMWS co-factor. This acceptance is a matter of common sense; it is not necessary to justify it by reference to PCV2. Any reduction in the volume of imported infected material must have a tendency to reduce the risk of infecting Australian pigs. The problem is that nobody can say whether the reduction would be great or small or sufficient to make a qualitative change in the risk. The Panel did not explain the basis upon, or the reasoning by which, it assessed the risk as having been reduced from `low´ (5% to 30%) to `very low´, that is, 5% or less. Dr Allan agreed with Mr Gleeson that, even after application of the recommended risk management measures, a carcass might still retain enough of the co-factor to cause PMWS infection: see paras 120 - 122 above.

275 Like everyone else, the Panel were unaware of the identity of the co-factor or co-factors that, with PCV2, cause PMWS. This was a huge problem, as the respondents´ experts agreed: see, for example, Professor Gardner at para 115 above and Professor Ellis at para 133.

276. The Panel reacted to the problem by making the conservative assumption that at least one co-factor was an infectious agent, possibly a new virus or a particularly virulent strain of PCV2. That was a reasonable course to take. However, it left the Panel in the position of dealing with an assumed infectious agent of whose characteristics they were unaware.

277 PCV2 is known to be a particularly hardy virus. So the Panel made a judgment that any co-factor virus was unlikely to be more hardy than PCV2. Counsel for the applicants criticised the Panel for taking that course. Professor Ellis did not think such a judgment could safely be made: see para 132 above. I understand counsel´s criticism; the Panel´s judgment may be wrong. However, I think it was open to an expert body to make this judgment.

278 On that basis, it seems to me, the Panel was entitled to treat PCV2 as a surrogate for the presumed infectious agent; in the sense that risk management measures that will eliminate the risk of PCV2 infection being imported may reasonably be regarded as ensuring the assumed PMWS infectious agent also will not survive importation.

279 However, the Panel did not know what measures are necessary to ensure PCV2 infection will not survive importation. Deboning and removal of the head, neck and major lymph glands must help. However, Dr Allan said he did not know the extent to which these steps would reduce or eliminate the volume of PCV2 in the carcass; he had never researched the topic: see para 122 above. Nor was he aware of research by anyone else: see para 123 above. Professor Ellis said, if these steps were taken, he thought the odds would be long on survival of enough infectious agent to cause transmission. But he agreed not much virus was needed for transmission to occur; the virus need not be multiplying in the meat, it is enough `if it´s there and it remains alive in a small dose´: see para 131 above.

280 Accepting the Panel´s entitlement to use PCV2 as a surrogate, in considering what measures were necessary to reduce the risk of infection by the assumed co-factor to `very low´, the Panel had no basis for moving beyond what they knew about PCV2. If they did not know whether the recommended measures would be effective to reduce the risk of PCV2 infection to `very low´, reference to PCV2 provided no basis for selection of the restrictions necessary to guard against the assumed PMWS infectious agent. Of course, the Panel might have commissioned some research about the effectiveness of the proposed restrictions against PCV2, and used the result of that research in coming to a surrogate conclusion about PMWS. However, the Panel did not take this course.

281 Another step the Panel might have taken was to commission research, probably overseas, similar to that undertaken in relation to PRRS. Such research might have demonstrated that any infectious co-factor of PMWS (whatever it was) does not survive deboning and removal of the head, neck and major lymph glands. It may have demonstrated that the infectious co-factor would not survive cooking the meat at a particular temperature for a particular period of time. Even though such research may not have revealed the identity of the PMWS co-factor, its results may have enabled the Panel to devise conditions that would be effective against the infectious co-factor, whatever it was.

282 Mr Basten rightly said that the Panel was not under a legal obligation to commission research. However, the difficulty is that, in the absence of such research, the Panel lacked the information crucial to the final step in their reasoning; with the result that the step lacked rational foundation.’

54 After considering the authorities his Honour stated (at [300]) that:

‘It appears to be clear that, for Wednesbury unreasonableness to be established, it is not enough that the reviewing court has reached the conclusion that the statutory decision-maker erred, even seriously, in his or her assessment of the facts. Although the matter has been expressed in various ways in particular cases, a recurrent theme is that there must be something that, in effect, vitiates the decision-maker’s exercise of discretion.’

55 His Honour found the reasoning of Menzies J in Parramatta City Council v Pestell [1972] HCA 59; (1972) 128 CLR 305 at 323-323 to be applicable.

56 His Honour found that, while there was no inconsistency or lack of logic in the application of the Panel’s selected methodology and criteria to the assessment of unrestricted risk, ‘(t)he situation in relation to the conversion of unrestricted risk into restricted risk is different’. His Honour stated (at [309]):

‘Although I accept the Panel’s entitlement to make the judgment that the assumed infectious co-factor of PMWS was not likely to be more hardy than PCV2, the Panel did not know what would be the effect of its recommended restrictions in relation to reduction of PCV2 infection. If this had been a matter about which there was some scientific information, it would have been for the Panel to assess that information. It would not have mattered that the information was ambiguous or scientifically controversial and that the Court might have preferred a different view about it to that of the Panel. It would have been for the Panel to evaluate the information and to decide whether, and if so how, to use it in coming to its ultimate conclusions. However, that was not the situation in the present case. Here there was no information whatever; the necessary scientific research had not been done. The Panel had no material whatever upon which it could base a judgment that the assessed ‘low’ unrestricted risk would become ‘very low’, if its recommended conditions were applied to future permits.’

57 His Honour rejected APL’s final ground of review, that ‘there was no evidence or other material to justify the making of the decision’, as his conclusion that the decisions were unreasonable depended on his finding that the final step in the Panel’s reasoning was unsupported by any fact, scientific evidence or scientific expertise. He stated (at [316]): ‘In other words, my conclusion depends upon a view of the situation that is the antithesis of what would be necessary for me to find before the ‘no evidence’ ground of invalidity would arise.’

58 On 15 June 2005, following submissions by the parties, his Honour made declarations and orders. We shall return to these below when we consider a jurisdictional issue which has been raised on the appeal.

APPLICATION OF RISK MANAGEMENT MEASURES; ‘LOW RISK’ TO ‘VERY LOW RISK’ ASSESSMENT; WEDNESBURY UNREASONABLENESS

59 His Honour regarded as crucial to the Panel’s reasoning the passage quoted at [47] above. While the Solicitor-General was somewhat apologetic about this passage and prayed in aid the latitude given by courts to loose language by administrative decision-makers, we think that, in context, the meaning is clear enough. The Panel’s approach has been to treat PCV2 as a proxy for the as yet unidentified PMWS co-factor. Since PCV2 has a number of adverse characteristics, the Panel assumed the co-factor to be as bad as PCV2 in respect of those characteristics. Therefore measures which might eliminate or reduce the presence of PCV2 would have a similar effect on the co-factor.

60 The decision-making function under consideration required:

• assessment of whether PMWS might be

- introduced

- established and

- spread

in Australia

• if so, what was the probable extent of the harm which might be caused
• what conditions might be adopted having as their object the

- prevention or

- control

of such introduction, establishment or spread and

• whether the resultant risk was "acceptably low"

61 The legislation does not suggest that quarantine decisions are to be made on an assumption that every scientific fact is known about every conceivable disease or pest that might be introduced into Australia, or that such decisions are to be delayed until all such facts are discovered and accepted. On the contrary, quarantine decisions have to be made in the existing state of knowledge. Imponderables have to be weighed and value judgements made. No specific criteria are laid down, other than the condition to be established must limit the level of quarantine risk to one which is "acceptably low" – which necessarily assumes there will be some risk.

62 In this setting, we think his Honour erred in applying, in effect, to each step in the pathway taken by the Panel a legal requirement for hard scientific data.

63 The Panel dealt with a number of other diseases in addition to PMWS. It adopted a complex and transparent decision-making process, the basic structure of which was not challenged (although there was an attack on some features such as the width of probability bands and the particular percentiles adopted). The Panel’s good faith and expertise are not in issue. If in some steps, or sub-steps, of the process in relation to PMWS the Panel used estimate, or analogy, or indeed speculation, the Panel might be guilty of unscientific procedures. However APL had to show that the ultimate decision was not just unreasonable, but so unreasonable that no other similarly qualified decision-maker would have made it. That test necessarily allows for some degree of unreasonableness. Even if error in reasoning is disclosed, a conclusion of Wednesbury unreasonableness requires a major step further. In Minister for Immigration and Multicultural Affairs v Eshetu [1999] HCA 21; (1999) 197 CLR 611 at [40] Gleeson CJ and McHugh J said:

‘... Someone who disagrees strongly with someone else’s process of reasoning on an issue of fact may express such disagreement by describing the reasoning as "illogical" or "unreasonable", or even "so unreasonable that no reasonable person could adopt it". If these are merely emphatic ways of saying that the reasoning is wrong, then they may have no particular legal consequence.

41 In Puhlhofer v Hillingdon London Borough Council [1986] UKHL 1; [1986] AC 484 at 518 Lord Brightman said:

"Where the existence or non-existence of a fact is left to the judgment and discretion of a public body and that fact involves a broad spectrum ranging from the obvious to the debatable to the just conceivable, it is the duty of the court to leave the decision of that fact to the public body to whom Parliament has entrusted the decision-making power save in a case where it is obvious that the public body consciously or unconsciously, are acting perversely." ’

Later their Honours (at [43]) repeated the warning of Mason CJ in Chan v Minister for Immigration and Ethnic Affairs [1989] HCA 62; (1989) 169 CLR 379 at 391 against courts ‘trespass(ing) into the forbidden field of review on the merits’.

64 Immediately before the passage in Eshetu quoted above, Gleeson CJ and McHugh J advert to a factual question in the case, namely the rejection by the Refugee Review Tribunal of evidence by an asylum-seeker concerning a student protest and subsequent arrests and ill-treatment of the protesters by authorities in Ethiopia. The Tribunal rejected his account because there was no mention of these events by human rights organisations or media at the time. Hill J at first instance had found this conclusion so unreasonable that no reasonable tribunal could reach it (although his Honour accepted that the Migration Act 1958 (Cth) prevented review on that ground). In the Full Court, Davies and Burchett JJ agreed with Hill J on this point but Whitlam J said that a finding to the contrary of that arrived at by the Tribunal would be ‘bordering on the perverse’. In that context, Gleeson CJ and McHugh JJ said:

‘Whitlam J was of the view that the reasoning displayed no error. Even if it did, however, there is a serious question whether the suggested error is of the kind to which the Wednesbury principle is directed. We are not here concerned, for example, with the unreasonable exercise of a discretion, and it is difficult to characterise the Tribunal’s decision, even on Hill J’s view of it, as an abuse of power.’

65 It seems therefore that it is inherently more difficult to impugn a decision on the ground of Wednesbury unreasonableness when the decision involves fact finding rather than the exercise of a discretion. Such a view would be consistent with the statement by Lord Brightman in Puhlhofer. It also accords with what was said as to the discoverability of specific error by Dixon, Evatt and McTiernan JJ in House v The King [1936] HCA 40; (1936) 55 CLR 499 at 505. After stating that discretionary decisions may be set aside if the primary judge (this was an appeal from a judicial decision but modern administrative law would apply the same principles to administrative decisions) acts upon a wrong principle, takes into account irrelevant matters, mistakes the facts or does not take into account some material consideration, their Honours continued:

"It may not appear how the primary judge has reached the result embodied in his order, but, if upon the facts it is unreasonable or plainly unjust, the appellate court may infer that in some way there has been a failure properly to exercise the discretion which the law reposes in the court of first instance."

66 In the present case, the Panel was not only concerned with fact rather than discretion, it had to make an assessment of future risk and measure that risk against the imponderable standard of acceptable lowness. An element of speculation, in the sense of assessing the likelihood of future occurrences, was necessarily involved: cf Minister for Immigration and Ethnic Affairs v Wu Shan Liang [1996] HCA 6; (1996) 185 CLR 259 at 277-278.

67 In essence, the Panel reasoned that the combination of modified dressing (removal of bones and peripheral lymph nodes) and cooking or curing would both reduce the likelihood of imported meat containing the virus and would lessen the likelihood that any given waste unit would contain enough of the virus to initiate infection. There was the further significant factor that by deboning and cooking or curing before import there would be less waste discarded in Australia.

68 His Honour accepted (at [274]) that this reasoning (reduction in volume of imported material likely to carry the virus = less risk of infection) was common sense. We agree. It can hardly be considered unreasonable. The problem for his Honour was the lack of quantification. But the question was not whether, in his Honour’s words (at [279]), what measures were necessary ‘to ensure PCV2 [as surrogate] infection will not survive importation’. The Panel took an unarguably reasonable, if unquantified, factual conclusion and applied it to a qualitative, verbal standard. One can legitimately argue that this was not an ideal process as a matter of scientific method. Perhaps, as was suggested in argument, some experiments might have been conducted. But the approach of the Panel cannot be characterised as one so unreasonable that no reasonable decision-maker could take it.

69 At a more detailed level, the reasoning of the Panel appears to have been based on scientific knowledge clearly articulated. For example it noted that lymphoid tissues are the primary target for PCV2 and for many other viruses. Thus removal of lymphoid tissue would reduce the risk of PCV2 (and hence its proxy), but not completely. So that particular element of risk was reduced from ‘moderate’ to ‘low’. Similarly the Panel assumed some level of the virus in the muscle (flesh) itself.

70 We would uphold the appeal on this issue.

WHETHER DECISION TO GRANT PERMIT ONLY TOOK INTO ACCOUNT ‘GENERIC’ RISK

71 In written submissions filed, pursuant to leave, after the oral hearing APL argued that even if the IRA Report were valid the Permit itself was invalid. In essence the argument was:

• Section 70 requires an assessment of the level of quarantine risk particular to that permit;

• Section 70, in the light of s 5D, mandated consideration of (a) the probability of introduction, establishment or spread of a disease, (b) the probability of the disease causing harm if the permit were granted, (c) the likely extent of the harm if the permit were granted, (d) the effect on each of (a), (b) and (c) of the imposition of conditions on the permit; and (e) whether the probabilities and probable extent in (d) after the imposition of conditions are ‘acceptably low’;

• Factors (a) and (b) require consideration of likelihoods and would most likely be considered over a period of time, as a rate; (c) is a measure of damage and is unqualified by any time period;

• Even if the whole of the IRA Report were valid, it did not of itself enable the decision-maker to address the mandatory considerations in s 70;

• The ‘generic assessment’ in the IRA Report could not satisfy the statutory obligation to consider all of the elements of level of quarantine risk in relation to this particular Permit.

72 APL summarised its argument as turning on the question whether the IRA Report in fact answered the description of it in the departmental recommendation dated 27 July 2004 for grant of the Permit, namely:

‘...an assessment, for the purposes of s 5D of the Quarantine Act, of the probability of and probable extent of harm from, the introduction and spread of disease from imported pig meat and the effect of imposition of conditions of import on those risks.’

73 It will be recalled that the IRA Report was also concerned with other pig diseases apart from PMWS and was not specific as to country of origin. The departmental recommendation, however, was confined to four applications to import pig meat from the United States. The recommendation reported on investigations by Biosecurity Australia into United States arrangements including, between 21 May and 7 June 2004, a ‘systems’ audit of the US Federal Meat Inspection Program for exports of pig meat by Dr Andrew Cupit, the Department of Agriculture, Fisheries and Forestry’s (DAFF) Veterinary Counsellor based in Washington. A copy of Dr Cupit’s report was attached to the recommendation. The report concluded that the US meat inspection program was structurally and functionally similar to the export meat inspection program administered by AQIS in Australia and would fully meet the conditions set out in the Determination.

74 The recommendation stated, amongst other things, that the Director needed to be satisfied conditions set out in Attachment B of the permits would limit the quarantine risk to one that is acceptably low. The Permit itself has numerous conditions. Some, eg (g) dealing with the removal of head and neck tissues, clearly have their source in the IRA Report. Others such as (d) (pigs resident in US or Canada since birth) and (f) (US is free from foot and mouth disease and other specified diseases) relate to other sources of information available to the decision-maker, including, presumably, Dr Cupit’s report.

75 So it is clear that the decision to grant the Permit was not based on a ‘generic’ assessment of risk, assessed without reference to the particular country from which pig meat would be imported under the Permit.

76 Further, the recommendation on its face does not, as APL’s submissions imply, put the IRA Report forward as the only consideration to be taken into account in the assessment of risk. The recommendation states (emphasis added):

‘On 10 May 2004 the Director of Animal and Plant Quarantine (and Secretary of the DAFF) accepted the recommendations in the Final IRA Report and made a Policy Determination that the importation of pig meat be permitted subject to certain conditions depending on the health status of the exporting country or zone (Attachment D). Under the previous import policy, only Canada, Denmark and New Zealand were permitted to export pig meat to Australia. The new conditions for importation of pig meat (Attachment E) set out in the Final Report permit other countries to export pig meat to Australia provided the product meets the stringent risk management measures set out in that policy including sourcing from country, zone or herd free from disease; testing of the carcass; cooking, freezing, curing or canning; and removal of certain tissues or parts of the carcass (head, neck, bones and major lymph nodes). The Australian Quarantine and Inspection Service (AQIS) takes the Final Report into account when considering applications for importation of pig meat. The Report is an assessment, for the purposes of section 5D of the Quarantine Act, of the probability of the probable extent of harm from, the introduction and spread of disease from imported pig meat and the effect of imposition of conditions of import on those risks. This assessment is taken into account when making an assessment of the level of quarantine risk if the permit were to be granted for the purpose of section 70 of the Proclamation and the assessment of whether, if the permit were granted, the imposition of conditions on it would be necessary to limit the level of quarantine risk to one that is acceptably low.’

The words shaded are quoted in APL’s submissions. Viewed in context, especially in the light of the words underlined, they do not fairly represent what the document was saying about itself.

77 This was consistent with the terms of the Determination itself which said that it was ‘to be taken into account by decision makers in accordance with the Quarantine Act 1908 and the Quarantine Proclamation 1998 as amended’.

78 The delegate of the Director was entitled, and required, to bring together the elements referred to in s 5D in an overall assessment of risk, taking into account advice received, including, but not confined to, the IRA Report and the Determination. This in fact happened. There was no failure by the delegate to comply with s 5D.

‘CONDUCT’; ADJR JURISDICTION

79 After hearing argument as to the appropriate terms of relief his Honour delivered a separate judgment on 15 June 2005 (Australian Pork Limited v Director of Animal and Plant Quarantine [2005] FCA 789) in which he:

1. Declared that any decision to authorise the importation of pig meat into Australia in reliance upon compliance with the risk management measures specified in the IRA Report would be an improper exercise of power;

2. Declared that the decision to grant the Permit was an improper exercise of power;

3. Ordered that that part of the Determination which ‘authorised the issue of permits to import pig meat into Australia’ in reliance upon compliance with the risk management measures specified therein ‘be set aside’;

4. Ordered that the Director be prohibited from making a decision to grant a new permit for the importation of pig meat into Australia in reliance upon compliance with such measures;

5. Ordered that the Permit be set aside.

80 His Honour said (at [4]) that the making of the Determination was ‘conduct for the purpose of making a decision to which (the ADJR Act) applies’, the decision being the decision to grant the Permit.

81 On the appeal the Director submitted that the order setting aside the Determination (No 3 above) was beyond the power conferred on the Court by s 16(2) of the ADJR Act. That provision empowers the Court, on an application for an order of review in respect of ‘conduct’, to make orders declaring the rights of the parties in respect of any matter to which the conduct relates or directing any of the parties to do, or refrain from doing, any act or thing.

82 We agree that the order in question does not come within the terms of s 16(2). It does not declare any rights or order anybody to do, or not do, anything.

83 Further, the making of the Determination was not ‘conduct’ for the purposes of review under s 6 the ADJR Act. As explained by Mason CJ in Australian Broadcasting Tribunal v Bond [1990] HCA 33; (1990) 170 CLR 321 at 341-343,

‘...the concept of conduct looks to the way in which the proceedings have been conducted, the conduct of the proceedings, rather than made along the way with a view to the making of a final determination. Thus, conduct is essentially procedural and not substantive in character.’

The complaint about the Determination was not about procedures, such as failure to accord procedural fairness; it was about its substantive merits.

84 APL relied alternatively on the power conferred by s 23 of the Federal Court of Australia Act 1976 (Cth), jurisdiction having been conferred on the Court by s 39B of the Judiciary Act 1903 (Cth). Section 23 provides:

‘The Court has power, in relation to matters in which it has jurisdiction, to make orders of such kinds, including interlocutory orders, and to issue, or direct the issue of, writs of such kinds, as the Court thinks appropriate.’

However, there must be some right, whether legal, equitable or statutory, to base entitlement to the order, the kind of which s 23 leaves to the Court. An analogy may be found in Australian Broadcasting Corporation v Lenah Game Meats Pty Ltd [2001] HCA 63; (2001) 208 CLR 199 where the High Court held that the statutory conferral on the Supreme Court of Tasmania of power to grant interlocutory injunctions in cases where it appeared to the Court to be just and convenient to do so was not at large. Such an order could only be made in protection of some legal or equitable right which the Court might enforce by final judgment: per Gleeson CJ at [11] and Gummow and Hayne JJ at [105].

85 The Determination did not ‘authorise’ anything. It did not affect anyone’s rights or impose obligations. On its face, as already mentioned, it did no more than put forward matters to be taken into account by the Director in granting permits. There was no jurisdictional error because no statute conferred jurisdiction to make the Determination; it was a purely internal administrative exercise.

86 If, contrary to our view, the grant of the Permit was, in the light of all the circumstances taken into account, including the IRA Report and the Determination, a decision so unreasonable that no reasonable decision-maker could make it, then the grant of the Permit would be invalid. If APL were correct on its substantive case, the orders and declarations made by his Honour, other than No 3, would be adequate to give effect to its rights as so found. The case of APL on the appeal did not include any explanation as to why Order No 3 was practically important for the protection of its rights.

THE NOTICE OF CONTENTION

87 By a notice of contention APL sought to uphold the judgment below on a number of grounds rejected by his Honour. Those pressed on the hearing of the appeal were:

(i) the ‘virtually certain’ introduction of PMWS cannot be consistent with what is ‘acceptably low’;
(ii) there was no evidence of the proposition that there was a scientific basis for determining the effectiveness of the conditions imposed; and
(iii) there was no assessment of quarantine risk in fact or law.

‘acceptably low’

88 APL pointed to the finding of his Honour at [245]:

‘It is clear that PMWS has had devastating effects on pig herds in many countries. PMWS currently costs the European Union about 600 million Euros per year. It is common ground that, so far, Australia is free of the disease. Yet the undisputed evidence of Professor Morris is that, if permits are granted in accordance with the policy embodied in the IRAR (and with full application of the Panel’s recommended conditions), there is a ‘high’ risk – that is, an over 70% chance – at the 75^th and 95^th percentiles (‘moderate’ at the 50^th percentile) that, within five years, PMWS will have spread to the general population of Australian domestic pigs, including medium-large piggeries. The IRAR itself, looking further ahead, showed a 99% chance at the 50^th percentile (100% at the 95^th percentile) of one or more outbreaks over ten years (Table 1, Annex C in the Annexes volume). In other words, under the policy that has now been adopted by the Director, an outbreak of PMWS within ten years is a virtual certainty. Indeed, according to Table 1, the problem may be more imminent. The Table shows a 38% chance at the 50^th percentile (98% at the 95^th percentile) of an outbreak as early as the first year.’

89 It was said that once it is recognised that consequences of the introduction of the PMWS were so substantial, no reasonable decision-maker could have reached the decision to which the Panel came. While his Honour (at [246]) characterised the assessment of such a risk as ‘acceptably low’ as ‘bizarre’, his Honour found that no error of law was disclosed. His Honour (at [308]) dealt succinctly with the complaints about the Panel’s methodology and reasoning. We shall return to this later. But on the point at issue it has to be stressed that the statutory criterion was not whether the risk was low but whether it was acceptably low. The legislation assumes that there may be a risk, but that some risk has to be accepted.

90 Moreover, the figure of 600 million euros for the European Union represents less than 2 euros per head per annum of that population. PMWS is a syndrome of pigs. It does not affect human health or other animals whether commercial, domestic or indigenous, or the environment. The effect of PMWS on a worst case scenario would be to increase domestic production costs. The estimate by APL was that an epidemic of PMWS in Australia similar to that overseas could add 15 per cent to the cost of pig meat production in affected herds. There would unlikely be any effect on exports because other countries do not impose quarantine regulations for PMWS.

No evidence

91 This was put as an alternative to the Wednesbury unreasonableness ground in relation to the effect of the imposed conditions.

92 The ‘no evidence’ ground in the ADJR Act (s 5(1)(h) and (3)(b), s 6(1)(h) and 3(b)) can only be made out if, relevantly, the decision or proposed decision is based on a ‘particular fact’ and that fact ‘does not exist’. The ‘particular fact’ here is said to be the ‘proposition that there was a scientific basis for determining that the proposed measures will reduce the risk of entry and exposure of PCV2’.

93 This argument must be rejected. Observations or comments about the evidence are not ‘particular facts’: Mohammed v Minister for Immigration and Multicultural Affairs [2000] FCA 264 at [15]. Findings, assumptions or predictions reflect ‘particular facts’. They are not particular facts in themselves.

Assessment of quarantine risk

94 One particular point stressed by APL was the failure of the Panel to elucidate how the risk would increase if importation continued on the same terms ‘for longer periods within a realistic timeframe, such as five years or ten years’. His Honour (at [293]) considered the Panel’s decision to limit their assessment of risk to a 12 month period could be criticised but was not something which reflected an error of law or a failure to consider a relevant circumstance. Section 70 only required two matters for consideration, the level of quarantine risk determined and possible conditions. The Director was commanded to consider the proposed effect of granting a particular permit which is then under consideration. The section did not require the Director to make or adopt long-term policy intended to guide various decision-makers over an indefinite period of time. The IRA Report was in itself not a statutory decision effecting rights. The permit decision by s 70 required consideration only on the merits of the particular application. In the present case the permit was for two years. Section 70 says nothing about the cumulative effect of permit approvals whether over 12 months or a longer period.

95 We see no error in his Honour’s reasoning. Indeed to expect the Panel to have assessed risks over a ten year period, as one of APL’s witnesses suggested, would be quite unrealistic. It is not possible to predict the state of scientific knowledge over such a period. In ten years time the prevalence of diseases can wax and wane, treatments may be discovered. There would be ground for criticism of irrationality of the system in which one or two year permits were determined on the basis of such extrapolations.

96 The respondents criticised the use of the 50^th rather than the 95^th percentile and the broadness of the probability bands and the failure to make findings as to consequences, for example the death of pigs, loss of jobs, revenue loss etc.

97 His Honour, while agreeing with much of this criticism, held (at [308]) that they only went to the soundness of the Panel’s opinion as to the level of unrestricted risk. Although the Panel adopted the methodology and criteria that were, in APL’s submission, likely to cause the Panel to underestimate the level of quarantine risks it was, his Honour thought, for the Panel to determine both the manner of its assessment of risk and the level of risk that it was prepared to regard as low. The Panel did not exhibit any inconsistency or lack of logic in applying selected methodology and criteria to the assessment of unrestricted risk.

98 We agree with his Honour’s conclusion. APL’s case on the notice of contention, as on the appeal, amounted to an attempt to move into the Court the exercise of risk assessment which Parliament has conferred on an administrative decision-maker.

CONCLUSION

99 The appeal should be allowed. The declarations and orders made by the primary judge should be set aside and in lieu thereof it should be ordered that the application should be dismissed with costs. APL should pay the Director’s costs of the appeal.

I certify that the preceding ninety nine (99) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justices Heerey and Lander.

Associate:

Dated: 16 September 2005

IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY	NSD 994 of 2005

ON APPEAL FROM A JUDGE OF THE FEDERAL COURT OF AUSTRALIA

BETWEEN:	DIRECTOR OF ANIMAL AND PLANT QUARANTINE APPELLANT
AND:	AUSTRALIAN PORK LIMITED FIRST RESPONDENT WINDRIDGE FARMS PTY LIMITED SECOND RESPONDENT FAYMAN INTERNATIONAL PTY LIMITED (ACN 002 797 079) THIRD RESPONDENT
JUDGES:	HEEREY, BRANSON & LANDER JJ
DATE OF ORDER:	16 SEPTEMBER 2005
WHERE MADE:	SYDNEY

REASONS FOR JUDGMENT

BRANSON J

INTRODUCTION

100 The Quarantine Act 1908 (Cth) (‘the Act’) plays a critical role in protecting Australia from exotic diseases and pests. This appeal arises against a background of concern about protecting Australia from an exotic disease affecting pigs. That disease is post-weaning multi-systemic wasting syndrome (‘PMWS’). PMWS is an important emerging disease in pigs which has been recognised in the USA, the UK, most of continental Europe, Asia and most recently New Zealand. Australia is presently free of PMWS.

101 The Act was significantly amended by the Quarantine Amendment Act 1999 (Cth) (‘the Amending Act’). Amendments made by the Amending Act are central to this appeal. They reflect the adoption by Australia of a quarantine policy of managing quarantine risk to an acceptably low level rather than seeking to eliminate quarantine risk. The explanatory memorandum for the Quarantine Amendment Bill 1998 (which when enacted became the Amending Act) described the new policy as ‘based on scientific reasoning and ... consistent with international rules and standards’.

102 Under the new policy the appellant made a Policy Determination (‘the Determination’) concerning the importation of pig meat into Australia which reflected her acceptance of the recommendations contained in a report of a Final Risk Analysis undertaken by an expert panel. Thereafter a delegate of the appellant, after taking into account the Policy Determination, granted a permit (‘the Permit’) for the importation of pig meat into Australia. The primary judge upheld a challenge to the validity both of the Determination and of the Permit.

103 I have had the benefit of reading in draft the joint reasons for judgment of Heerey and Lander JJ on this appeal. I agree with their Honours, for the reasons given by their Honours, that this Court has no power to review the decision of the Director to make the Determination.

104 Unfortunately I take a different view from their Honours on the issue of the validity of the Permit. For the reasons set out below, I would dismiss the appeal to the extent that it challenges the declaration made by the primary judge that the decision to grant the Permit was an improper exercise of the power conferred on the decision-maker by the Act and the Proclamation and to the order made by the primary judge that the Permit be set aside.

STATUTORY SCHEME

105 Section 8B(1) of the Act provides that there shall be a Director of Animal and Plant Quarantine (‘the Director’). The Director is, under the Minister, charged with the execution of the Act and any regulations and proclamations in force under the Act in relation to animal and plant quarantine. The Secretary of the Department of Agriculture, Fisheries and Forestry was at all relevant times the Director (s 9AA(1) of the Act). The Director is a ‘Director of Quarantine’ within the meaning of the Act (s 5 of the Act). A Director of Quarantine may delegate to an officer appointed under the Act all or any of his or her powers under the Act (s 5 and s 10B of the Act).

106 Section 13 of the Act includes provisions critical to the statutory scheme for managing quarantine risk in respect of exotic diseases. Section 13(1)(e) authorises the Governor-General, by proclamation, to prohibit the importation into Australia of anything likely, in his or her opinion, to introduce, establish or spread any disease. Section 13(2A) relevantly authorises a proclamation under subs (1) that provides that importation of a thing is prohibited unless a permit to import the thing is granted by a Director of Quarantine. Section 13(2AA) provides:

‘A Director of Quarantine may, for the purposes of subsection (2A), grant a permit that relates to a specified act, or a specified class of acts, in relation to a specified thing or a specified class of things.’

Section 13(2B) authorises a permit granted pursuant to a proclamation made in accordance with subs (2A) to be granted subject to the holder complying with conditions or requirements set out in the permit.

107 The Quarantine Proclamation 1998 (‘the Proclamation’) has been made by the Governor-General in reliance, principally, on s 13 of the Act. Section 39(1) of the Proclamation provides:

‘The importation into Australia of meat or a meat product ... is prohibited unless a Director of Quarantine has granted a permit to import the meat or meat product into Australia.’

108 Section 70 of the Proclamation controls the grant of import permits. It relevantly provides:

‘In deciding whether to grant a permit to import a thing into Australia ... a Director of Quarantine:

(a) must consider the level of quarantine risk if the permit were granted; and

(b) must consider whether, if the permit were granted, the imposition of conditions on it would be necessary to limit the level of quarantine risk to one that is acceptably low; and ...

(c) may take into account anything else that he or she knows that is relevant.’

109 The expression level of quarantine risk is relevantly defined in s 5D of the Act as follows:

‘A reference in this Act to a level of quarantine risk is a reference to:

(a) the probability of:

(i) a disease ... being introduced, established or spread in Australia ... ; and

(ii) the disease ... causing harm to human beings, animals, plants, other aspects of the environment, or economic activities; and

(b) the probable extent of the harm.’

110 The above definition of level of quarantine risk also applies to the phrase when used in the Proclamation (s 46 of the Acts Interpretation Act 1901 (Cth) as in force at the relevant time).

111 An important aspect of the statutory scheme outlined above is that it requires any relaxation of a prohibition on the importation of any particular thing to be undertaken on a case by case basis; that is, by giving consideration to a particular application for the grant of a permit to import the thing. The scheme does not provide for a generic relaxation of a prohibition on importation; for example, by a general authorisation of importation of the particular thing provided that certain conditions are met.

BACKGROUND

112 On 30 July 2004 a delegate (‘the Delegate’) of the Director granted the Permit to Fayman International Pty Limited (‘Fayman’) to import from a named exporter uncooked, boneless pig meat into Australia from the United States of America. The Permit was expressed to be valid from 30 July 2004 to 30 July 2006. Conditions were imposed on the Permit.

113 Before granting the Permit the Delegate gave consideration to a minute dated 27 July 2004 (‘the Minute’) from a Senior Assessing Officer of the Biologicals Unit of the Australian Quarantine and Inspection Service (‘AQIS’). The Minute recommended:

‘That you grant permits to applicants noted in Attachment A to import pig meat from the United States of America under the conditions listed in Attachment B.’

114 The body of the Minute set out, amongst other information, the following information under the heading ‘BACKGROUND’:

‘- On 19 February 2004, in Animal Biosecurity Policy Memorandum 2004/01, Biosecurity Australia released the Final Import Risk Analysis (IRA) Report (the Final Report) on importation of pig meat to Australia ...

- On 10 May 2004 the Director of Animal and Plant Quarantine (and Secretary of the DAFF) accepted the recommendations in the Final IRA Report and made a Policy Determination that the importation of pig meat be permitted subject to certain conditions depending on the health status of the exporting country or zone (Attachment D). Under the previous import policy, only Canada, Denmark and New Zealand were permitted to export pig meat to Australia. The new conditions for importation of pig meat (Attachment E) set out in the Final Report permit other countries to export pig meat to Australia provided the product meets the stringent risk management measures set out in that policy ... The Australian Quarantine and Inspection Service (AQIS) takes the Final Report into account when considering applications for importation of pig meat. The report is an assessment, for the purposes of section 5D of the Quarantine Act, of the probability of and probable extent of harm from, the introduction and spread of disease from imported pig meat and the effect of imposition of conditions of import on those risks. This assessment is taken into account when making an assessment of the level of quarantine risk if the permit were to be granted for the purpose of section 70 of the Proclamation and the assessment of whether, if the permit were granted, the inspection of conditions on it would be necessary to limit the level of quarantine risk to one that is acceptably low.’ (emphasis added)

115 Under the heading ‘ISSUES’ the Minute, after referring to s 13 of the Act, s 70 of the Proclamation and the definition of level of quarantine risk found in s 5D of the Act, stated:

‘You need to be satisfied that the imposition of the conditions set out in Attachment B on the import permits will limit the quarantine risk to one that is acceptably low and that you are not aware of any reason not to adopt conditions derived from the Final Report.’

116 The Determination referred to in the Minute is in the following terms:

‘I am satisfied that the import risk analysis has been completed following the administrative process set out in Biosecurity Australia’s Import Risk Analysis Handbook 2003.

Import of pig meat will be subject to the Quarantine Act 1908 and the application of measures as specified in the section on Quarantine Requirements in the Final Import Risk Analysis (IRA) Report for Pig Meat (February 2004). These measures are designed to limit quarantine risk to a level that is acceptably low.

This policy is to be taken into account by decision makers in accordance with the Quarantine Act 1908 and Quarantine Proclamation 1998 as amended.’

117 On 27 July 2004 the Delegate sought further advice on factors considered in the Import Risk Analysis on the importation of pig meat (‘the IRA’). That advice was provided to him under cover of a fresh minute dated 30 July 2004 from the Senior Assessing Officer. This minute recommended that he ‘... grant the import permits for pig meat from the USA in Attachment A of my submission 27 July 2004’. The Delegate wrote ‘Agreed’ on this minute and initialled and dated it ‘30/7/04’.

118 Fayman was advised by a letter dated 30 July 2004 that it had been granted the Permit. It was further advised by this letter of the commencement of the proceeding which has given rise to this appeal.

CONSIDERATION

119 As the appellant acknowledges, s 70 of the Proclamation imposed two mandatory requirements on the Delegate in deciding whether to grant the Permit. Those mandatory requirements are contained in pars (a) and (b) of s 70 of the Proclamation. First, the Delegate was required to consider ‘the level of quarantine risk if the permit were granted’. Secondly, he was required to consider ‘whether, if the permit were granted, the imposition of conditions on it would be necessary to limit the level of quarantine risk to one that is acceptably low’.

120 In my view, it is apparent that, having regard to the ordinary meaning of the language of s 70 of the Proclamation, the mandatory obligations imposed on a decision-maker by s 70 were directed at the level of quarantine risk associated with the particular importation which, but for the grant of the Permit, would be prohibited. I do not understand the appellant to have contended otherwise.

121 Nonetheless, as par (c) of s 70 of the Proclamation makes clear, in deciding whether to grant a permit to import a thing into Australia a decision-maker may take into account anything in addition to (but not in substitution for) the matters identified as mandatory considerations that he or she knows that is relevant. The Determination requires decision-makers to take into account the policy that importations of pig meat will be subject to the Act and the application of measures as specified in the section on Quarantine Requirements in the IRA Report. The IRA, which is concerned to assess the generic risk of the importation of pig meat into Australia, is likely to be relevant to most cases in which a permit to import pig meat into Australia is sought. A decision-maker is likely in most cases to find the IRA of assistance in a number of respects when he or she is considering the level of quarantine risk if the permit were granted – although the IRA is unlikely to be determinative of that question. A decision-maker is also likely in most cases to find the IRA of assistance when he or she is considering whether, if the permit were granted, the imposition of conditions on it would be necessary to limit the level of quarantine risk to one that is acceptably low. Additionally, the IRA could independently of the above factors be something else that a decision-maker knows that is relevant to the question of whether a permit should be granted. The permit, if granted, is unlikely to be the only permit concurrently authorising the importation of pig meat into Australia.

122 In the context of this appeal, however, it is the content of the mandatory obligations imposed on a decision-maker with authority to grant a permit under s 70 of the Proclamation which, in my view, is critical. The content of those mandatory obligations can only be understood by reference both to s 70 of the Proclamation and to s 5D of the Act. This is because s 5D has the effect that the reference in s 70 to the level of quarantine risk is to be read as a reference to the matters identified in pars (a) and (b) of s 5D.

123 The first respondent submitted that the effect of reading s 70 of the Proclamation in conjunction with s 5D of the Act is that in this case the Delegate was required, in deciding whether to grant the Permit, to give consideration to:

‘(a) the probability of introduction, establishment or spread of a disease or pest if the permit is granted;

(b) the probability of the disease or pest causing harm if the permit is granted;

(c) the likely extent of the harm if the permit is granted;

(d) the effect on each of (a), (b) and (c) of the imposition of conditions on the permit; and

(e) whether the probabilities and probable extent in (d) (after the imposition of conditions) are "acceptably low".’

124 The appellant submitted that:

‘[t]he phrase "level of quarantine risk", defined in s 5D, necessarily involves some form of assessment which results in the "level" of risk being identified (whether qualitatively or quantitatively). The purpose of the definition is to confirm that "risk" is a concept which encompasses assessment of the probable extent of the harm as well as the likelihood of harm occurring. In any event it is clearly open to a decision-maker, required to "consider" the level of quarantine risk under s 70 of the Proclamation, to bring together the elements referred to in s 5D into an overall assessment of risk.’ (original emphasis)

125 I understand the submission of the appellant to mean that a decision-maker is entitled to consider a level of quarantine risk by making an overall assessment of risk without first evaluating separately the three factors identified in s 5D. That is, that it would be a theoretically permissible approach, for example, for a decision-maker to proceed on the basis that it would be appropriate to grant a particular permit because, whatever the level of quarantine risk might be if the permit were granted (ie whether acceptably low or unacceptably high), the imposition of conditions on the permit would necessarily limit the level of quarantine risk to one that is acceptably low. I turn to consider whether such an approach is consistent with the proper construction of s 5D of the Act.

126 Section 5D was introduced into the Act by s 60 of the Amending Act. Other sections of the Amending Act, and in particular s 210 and s 211, assist in determining the proper construction of s 5D.

127 Section 210 of the Amending Act repealed subs 52A(1) to (4) of the Act and substituted therefore the following subsections:

‘(1) A person authorised by a Director of Quarantine may examine any animal or plant that is subject to quarantine and is on board an installation.

(2) A quarantine officer must:

(a) if he or she is of the opinion that there is an unacceptably high level of quarantine risk in respect of the animal or plant--order the animal or plant into quarantine; or

(b) otherwise--release the animal or plant from quarantine.’ (emphasis added)

Before the commencement of the Amending Act s 52A was drawn in terms such as ‘free of any risk ...’

128 Section 211 of the Amending Act also repealed subs 53(2) to (4) of the Act and substituted therefore a subsection which referred to ‘an unacceptably high level of quarantine risk’. Section 53 had previously been drawn in terms apt to reflect a perceived absence of quarantine risk.

129 The references in s 52A and s 53 of the Act to a level of quarantine risk that is ‘unacceptably high’ provide a strong indication of a legislative intent that a level of quarantine risk in the sense explained in s 5D is something that may aptly attract a qualitative description such as ‘unacceptably high’ or ‘unacceptably low’. For this reason I conclude that s 5D is not to be construed literally. If the section were construed literally a reference in the Act to a level of quarantine risk would be a reference to three separate things (ie the two probabilities identified in subs 5D(a) and the assessment identified in subs 5D(b)).

130 Nonetheless, weight must be given to the actual language of s 5D of the Act. The section says that a reference in the Act to a level of quarantine risk is a reference to the things identified in the section.

131 In my view, the language of s 5D, understood in the context provided by the Act, demonstrates that a level of quarantine risk is something derived from the three factors identified above. That is, that it is a product, or a function, of those three factors in the sense that it is an assessment of their cumulative impact. It is not something that can be assessed in the absence of an evaluation of those three factors.

132 It follows, in my view, that the obligation imposed on a decision-maker by par (a) of s 70 of the Proclamation to consider the level of quarantine risk if the permit were granted necessarily requires the decision-maker to evaluate:

•	the probability of a disease being introduced, established or spread in Australia if the permit were granted;

and

•	if it is concluded that there is such a probability, the probability of the disease causing harm to human beings, animals, plants, other aspects of the environment, or economic activities;

and

•	if it is concluded that there is such a probability, the probable extent of the harm.

133 Having evaluated these three things, the decision-maker must then assess the level of quarantine risk if the permit were granted. As mentioned in [129] above, an assessment of a level of quarantine risk may be made in qualitative terms – although there seems to be no reason to conclude that it cannot, as a matter of law, be made with greater precision if the available information, both scientific and otherwise, so allows. Critically, however, a level of quarantine risk is derived from, and not independently of, the three factors identified in s 5D of the Act. For this reason, as is explained below, the level of quarantine risk if any particular permit is granted is not determined by the IRA.

134 The assessment contained in the IRA was, as the title and content of the IRA Report reveal, a generic assessment of the risk of allowing imports of pork meat into Australia. The Executive Summary at the beginning of the IRA Report states:

‘The IRA is "generic" in that it is not restricted to specific importing countries; the import conditions recommended as a result of the IRA are applicable to any country provided that they can be met to the satisfaction of Australian authorities ...

The IRA provides the basis for response to access requests for pig meat from Brazil, Canada, Chile, European Union (EU) Member States, Hungary, Korea, Mexico, New Zealand, South Africa, Taiwan and the United States of America (USA).’

135 The IRA was not only generic in that it was not restricted to specific exporting countries. It was based on an assessment of the total volume of uncooked pig meat that might be imported into Australia if trade were permitted without restrictions. It was also based on an assumption that all imported pig meat would be distributed as if it were domestically produced, and that households and food service establishments (restaurants, cafes, take away fast food outlets, institutions etc) would have access to imported pig meat product. An estimate was made as to the proportion of pig meat that would be purchased by food service establishments as fresh meat and small goods and the proportion that would be purchased by households. As a critical risk factor in respect of pig meat as a potential carrier of disease is the proportion discarded as waste, the assumed distribution of imported pig meat within Australia was an important element of the IRA. Further, the IRA was concerned to assess on an annual basis the generic risk of importing pig meat into Australia rather than the risk of importing pig meat over any specific period.

136 The purpose of the IRA process is described in the IRA Report as:

‘... to deliver a policy recommendation to the Director of Animal and Plant Quarantine that is characterised by sound science and by transparency, fairness and consistency.’

137 As the above description makes clear, the IRA was not intended to assess the level of quarantine risk attending the grant of any particular permit to import pig meat into Australia. Its purpose was to provide a sound basis for the formulation of a policy position on whether the importation of pig meat into Australia should be generally allowed and, if so, on what conditions generally.

138 The level of quarantine risk attending the grant of any particular permit might be manifestly higher or lower than the generic risk attending the importation of pig meat into Australia. For example, the importation of a small amount of pig meat into Australia for the purpose of scientific research at a secure research station which has a protocol of incinerating at high temperatures all waste might be thought to be virtually free of quarantine risk – even in the absence of the import conditions recommended as a result of the IRA. On the other hand, the importation of a large amount of pig meat into Australia, where the meat is to come from carcasses derived from pig herds known to be infected to a high level with PMWS, for the purpose of supplying pork products to retail shops, might be thought to be attended by a quarantine risk higher than the generic risk assessed by the IRA. In every case a decision-maker will need to bear in mind that the IRA is concerned to assess risk on an annual basis; the permit that he or she is giving consideration to granting may not be a permit to import pig meat for a year.

139 At first instance the first respondent provided particulars of alleged errors of law affecting the decision to grant the Permit. One of those particulars was described by the primary judge as item (e) of the alternative particulars. It was in the following terms:

‘The decision [scil. decision-maker] failed to consider the level of quarantine risk and its acceptability in respect of each particular permit sought or likely to be sought.’

140 The primary judge at [297] observed:

‘Insofar as item (e) of the alternative particulars relates to the Permit Decision, it is not misconceived. However, it is factually incorrect. The issue stated in item (e) was the issue with which Dr Carroll was concerned. Dr Carroll did consider the level of quarantine risk in relation to the application by Fayman. He did so by reference to the IRAR [IRA Report]. If there was an error in the IRAR sufficient to lead to a conclusion that the IRA Decision was legally invalid, this will have a flow-on effect to the Permit Decision. But it is not possible to say that Dr Carroll failed to take into account a relevant consideration.’

141 In my respectful view, the above paragraph discloses that his Honour failed to appreciate the true nature and significance of the IRA. The IRA was not an assessment of the level of quarantine risk if the Permit were granted. Nonetheless, it is plain that his Honour made a finding, which I do not understand to be challenged, that the Delegate considered the level of quarantine risk if the Permit were granted by reference to the IRA Report.

142 The appellant submitted that the primary judge ‘clearly did not make a finding that consideration of the issues had occurred "only" by reference to the IRA Report’. The appellant placed reliance on [293] of his Honour’s reasons for judgment which is in the following terms:

‘I will start with item (a). Although I have criticised the Panel’s decision to limit their assessment of risk in the IRAR to a 12 month period, I do not think this decision reflects an error of law or a failure to consider a relevant circumstance. Clause 70 of the Proclamation sets out the matters that the Director is bound to consider in deciding whether to grant an importation permit under cl 39. Relevantly, there are only two required matters of consideration: "the level of quarantine risk if the permit were granted" and possible conditions. The Director is commanded to consider the effect of granting the particular permit which is then under consideration. The clause does not require the Director to make, or adopt, a long-term policy intended to guide various decision-makers over an indefinite period of time. The Director is free to take that course: the IRAR was intended to be such a policy. However, it was not, and was never intended to be, itself a statutory decision. No statutory criteria applied to it. Accordingly, whatever the merit of the Panel’s decision to limit their risk assessment to a 12 month period, this does not result in legal invalidity. So far as the Permit Decision is concerned, cl 70 requires consideration only of the merits of the particular application. It says nothing about the cumulative effects of many permit approvals, whether over 12 months or a longer period.’

143 The significance of the above paragraph from his Honour’s reasons for judgment cannot be assessed in isolation from the other paragraphs of his Honour’s reasons for judgment and the order made by him on 15 June 2005. The order made by his Honour on that day includes the following paragraphs:

‘3. That part of the IRA Decision which authorised the issue of permits to import pig meat into Australia in reliance upon compliance with the risk management measures specified in either of the sub-paragraphs [ie. sub-paragraphs three and four of paragraph 3.2(iii)(j) of that part of the IRA Report which is entitled ‘Quarantine Requirements for Importation of Pig Meat’] be set aside.

4. The first respondent be prohibited, by herself, her officers, delegates or agents from making a decision to grant a new permit for the importation of pig meat into Australia in reliance upon compliance with the risk management measures specified in either of the sub-paragraphs.’

144 In my view, it must be assumed that his Honour concluded that the Delegate granted the permit in reliance on the IRA as opposed to by following a process that involved merely taking the IRA into account. This conclusion is supported by reference to his Honour’s reasons for judgment which pay careful attention to the validity of the outcome of the IRA process. Detailed consideration is given in his Honour’s reasons for judgment to the validity of the assumptions that underpin the IRA and to the validity of the statistical and other methodology employed by those who undertook the IRA. His Honour did not attempt to extract for special consideration elements of the IRA which were of obvious significance for an assessment of the level of quarantine risk if the Permit were granted (see [132] above). As already mentioned, his Honour’s focus, no doubt because it was the parties’ principal focus, was on the final outcome of the IRA process and not with the validity of the individual steps of that process.

145 As is mentioned in [114] above, the Minute described the IRA as ‘an assessment, for the purposes of s 5D of the Act, of the probability of and probable extent of harm from, the introduction and spread of disease from imported pig meat and the effect of imposition of conditions of import on those risks’. This description is at best ambiguous particularly in light of the subsequent statement in the Minute that this ‘assessment is taken into account when making an assessment of the level of quarantine risk if the permit were to be granted’. The appellant accepts that the IRA does not constitute an assessment of the risk of granting the Permit. As identified above, it is an assessment of generic risk that has been used to inform Government policy and which is also capable of informing an assessment of a level of quarantine risk within the meaning of s 5D of the Act.

146 While the Minute set out the terms of s 70 of the Proclamation and s 5D of the Act, it provided little information upon which the Delegate could have made an assessment of the level of quarantine risk, in the sense discussed above, if the Permit were granted. The Minute did not seek to identify, for example, any factors peculiarly affecting quarantine risk if the Permit were granted. Factors of this kind that might have been identified include how the pig meat imported pursuant to the Permit would be distributed in Australia, that the pig meat would all come from the USA and that it would be imported into Australia over a two year period.

147 Nothing in the voluminous evidence before the primary judge records any assessment by the Delegate of the matters identified in s 5D of the Act. Indeed, nothing in the evidence suggests that the Delegate even turned his mind to the task which par (a) of s 70 of the Proclamation required of him.

148 Section 70 of the Proclamation prescribes the process to be followed by a Director of Quarantine, or his or her delegate, in deciding whether to grant a permit to import a thing into Australia. The Director of Quarantine, or his or her delegate, is obliged personally to give consideration to the things identified in pars (a) and (b) of s 70. Of course, he or she may do so by reference to information provided by others. He or she may additionally take into account anything else that he or she knows that is relevant (par (c) of s 70). Ultimately, however, his or her duty is to decide, within the restraints provided by the law and applicable policy determinations that accord with the law, whether to grant the permit to import the thing into Australia.

149 As mentioned above, the decision of the Delegate to grant the Permit is evidenced by the word ‘Agreed’ and his initials and a date endorsed by hand on the minute dated 30 July 2004 provided to him by the Senior Assessing Officer. Having regard to the absence of any other record pertinent to his decision-making process, it seems reasonable to infer that his decision was based on his consideration of the material provided to him in and with the two minutes prepared by the Senior Assessing Officer. That material was insufficient to enable him to undertake the obligation imposed on him by s 70 of the Proclamation. The Minute suggested that the only real issue for his consideration was whether he was satisfied that the imposition of the conditions derived from the IRA Report would limit the quarantine risk to one that was acceptably low. This was the basis upon which it can be inferred that the Delegate acted. The only additional information sought by him was confirmation concerning the validity of the approach adopted by the IRA panel.

150 In my view, the evidence before the primary judge gave rise to an irresistible inference that the Delegate, in deciding to grant the Permit, did not comply with the mandatory obligations of s 70 of the Proclamation. The Delegate did not evaluate the probability of PMWS being introduced, established or spread in Australia if the Permit were granted. He did not evaluate the probability of PMWS causing harm if introduced, established or spread in Australia or the probable extent of harm if PMWS were introduced, established or spread in Australia. Further, the Delegate did not consider whether, if the Permit were granted, the imposition of conditions on it would be necessary to limit the level of quarantine risk to one that is acceptably low. The Delegate proceeded on the basis that, provided he were satisfied concerning the methodology of the IRA and that the US meat inspection program was adequate to meet the conditions recommended by the IRA, he could satisfy the obligations imposed on him by s 70 of the Proclamation by granting the Permit subject to those conditions. This was not the approach mandated by s 70 of the Proclamation. To the extent that the Determination might be understood to suggest that the approach adopted by the Delegate was appropriate or necessary, the Determination does not accord with the law.

151 Nothing set out above is intended to reflect on the merit of the decision of the Delegate to grant the Permit. The merit of that decision is not a matter for determination by the Federal Court. The concern of this Court is with the legality of the decision to grant the Permit. The rule of law requires that a decision pursuant to s 70 of the Proclamation be made in accordance with the process mandated by the Act and the Proclamation. The Delegate’s decision to grant the Permit was not made in accordance with the mandatory requirements of s 70 of the Proclamation. The decision was thus affected by an error of law and was for that reason an improper exercise of the power conferred on the Delegate.

152 For the above reasons, in my view, the appeal from the declaration made by the primary judge that the decision to grant the Permit was an improper exercise of the power conferred on the decision-maker by the Act and the Proclamation and from the order made by his Honour that the Permit be set aside should be dismissed. However, I join with the other members of the Court in concluding that the appeal should otherwise be allowed. I would hear the parties on the question of costs.

I certify that the preceding fifty-three (53) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Branson.

Associate:

Dated: 16 September 2005

Counsel for the Appellant:	D M J Bennett QC S-G, S Gageler SC and G R Kennett
Solicitor for the Appellant:	Minter Ellison
Counsel for the Respondents:	J T Gleeson SC and M J Leeming
Solicitors for the Respondents:	Corrs Chambers Westgarth
Date of Hearing:	23 and 24 August 2005
Date of Judgment:	16 September 2005