PETS: Chapter 10 of the Kennedy report
Risk assessment
10.1 Introduction
10.1.1 In this Chapter, we refer to the risk assessment carried out on our behalf, the assumptions used in the calculations of risk, the outcome of the assessment, and our recommendations arising therefrom. Here we set out only the principal salient features.
10.1.2 The concept of risk is a central feature of any assessment of measures designed to prevent the import of rabies into Great Britain. 'Risk' in this context is regarded by risk assessors as the likelihood of a hazard occurring, where the 'hazard' is the occurrence of some undesirable event.
10.1.3 Risk can be expressed in at least two ways. The first is absolute risk', in which the likelihood of a hazard occurring is expressed in terms of one such event every so many years (or months, or days). The second is 'relative risk' which, by contrast, gives the comparative risk of a hazard occurring under alternative policies. Both concepts are used in this analysis.
10.1.4 The principal outcomes of the analysis are estimates of the absolute and the relative risks of an imported cat or dog developing rabies. Two other outcomes are the risk of a human case of rabies in Great Britain, and the risk of an outbreak of rabies in a population of wild animals, especially foxes. Although we had only limited information, we have made some assessment of the risk of a human case of rabies. However, there are no reliable data from which to estimate the chance of transmission from a cat or dog to a fox, and we therefore resisted the temptation to extend the risk analysis this far.
Sources of Information
10.1.5 The data used in our assessment were taken from published and unpublished sources. Some estimates are based on hard data, some are based on educated guesses. Where necessary, to allow for the uncertainty, we have estimated the most likely (best), the lowest (low) and the highest (high) figures for each value. In determining the lowest and highest values, we have used the 5th and 95th centiles respectively (see paragraph A.10.19) Some important information, relating in particular to the movement of animals within the EU, was obtained by commissioning a survey of pet owners in Great Britain and certain other EU Member States. 373 The aim was to determine what the pattern of holiday-making with pets is now, and what it may be in the future, given that the quarantine policy may change.
Assumptions Made in the Risk Assessment
Number of animals currently imported
10.1.6 We took as the lowest estimate of the number of animals imported under the present quarantine system the number placed in quarantine (7,267 in 1996). 374 It is almost certain that more animals are imported in a typical year. The number caught entering Great Britain illegally in 1997 was 92; the actual number smuggled is obviously unknown. The telephone survey by DRSM addressed the question of smuggling but produced results from only a very small number of respondents and those results cannot be relied upon. In the absence of better data, we assumed that 100 animals per year are currently smuggled by British holidaymakers on return from the EU, and 100 by EU holidaymakers coming to Great Britain, with a wide range of variation in both figures of zero to 1,000. For animals imported to Great Britain from other countries, we took the number quarantined as the lower estimate, and added 10% and 50% to get best and upper limits. This gives a maximum of about 5,000 animals smuggled per year in total, which is consistent with the claims made, for example, by the Quarantine Abolition Fighting Fund. 375
Proportion of infected animals
10.1.7 The fraction of imported animals which will be infected depends on the incidence of rabies at source, and on the incubation period of the disease. For the latter, we have used a best estimate of 30 (low 15, high 44) days 376 (see paragraphs A10.12-13).
10.1.8 For the purpose of determining the incidence of rabies at source, we divided the world into regions according to the WHO classification, except that the Americas are split into Latin America and the Caribbean (LAC) and North America (NAM), Europe into the EU and Eastern Europe (EEU), and Australia and New Zealand (ANZ) are separated from the rest of the Western Pacific Region (WPR). 377 Our estimates of rabies incidence in the EU and North America are based on relatively reliable, routine surveillance data. 378,379 Incidences in other countries, where surveillance data are less reliable, are based on special studies. These incidence rates are, for example, 1,500 cases/million dogs/year in Guayaquil, Ecuador, 380 2,800 cases/million dogs/year in Lima, Peru, 381 and 2,400 cases/million dogs/year in Buenos Aires, Argentina. 382 Our estimate of incidence for the Eastern Mediterranean (EMR), Latin America and the Caribbean (LAC), South East Asia (ASI), Sub-Saharan Africa (SSA) and the Western Pacific (WPR) regions was 100 (with a range of 10-1,000 cases/million dogs/year) which is lower than might be suggested by these data because dogs imported to Great Britain from these regions are more likely to be vaccinated than average, and less likely to be exposed to infection. For instance, the majority of animals arriving from WPR in 1997 came from Hong Kong. The assumptions concerning the risk of an animal imported from any of the regions discussed above are based on the incidence in the country of origin. However, the animals actually imported are more likely to be protected by vaccination than the wider animal population of the country or region concerned, and there is therefore a lower risk that rabies might be introduced by them. Figure 10.1 sets out the figures on which the analysis is based.
Figure 10.1 - origins of prospective imported animals into Great Britain and the risk that they might be infected.Bars represent percentages calculated from the recorded numbers of all cats and dogs (white), the estimated numbers of animals smuggled to and from the EU (stippled), and the estimated numbers of infected cats and dogs (black).
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Increase in numbers of imported animals
10.1.9 To assess any potential risk, we required estimates of the number of animals that would be brought to Great Britain under any changed system. As a point of reference, we focused initially on the alternative which would replace quarantine with identification, vaccination and serological testing of cats and dogs arriving from the EU and EEA or travelling from Great Britain to Continental EU and back again.
10.1.10 The difficulties of predicting behaviour are well-known in market research. Nevertheless, in compiling figures of likely numbers of animals going to and arriving from continental Europe, we assumed that the DRSM survey results were likely to be reliable when respondents were asked simple questions about past or current behaviour, but unreliable when asked what their behaviour might be in the future. It was clear, for example, that British residents were not given sufficient opportunity in the telephone interview to reflect on the implications of their proposed future behaviour, such as the cost and inconvenience of transporting an animal by air. 383
10.1.11 We estimated the number of animals likely to travel between Great Britain and Continental Europe under any changed system, based on data describing the number of animals per household in Great Britain and the EU, and on the numbers of households which can be expected to take animals on holiday. Although the latter variable was the most difficult to assess, we assumed a variation from 3% to 9%. 384 This produced numbers in the range from 80,000 - 240,000 animals per year travelling from Great Britain to the rest of the EU and then returning, and 40,000 - 120,000 entering Great Britain from Continental EU.
Animals protected from infection
10.1.12 The number of animals which test positive after vaccination, and the number protected from infection can be estimated from abundant data on vaccine performance. 385,386,387,388,389 It is more difficult to assess the numbers of cats and dogs that would be vaccinated, and the number that would be serologically tested following vaccination. We therefore calculated the risk on the assumption that the proportion of animals to be vaccinated in future was the same as the proportion of animals currently imported into quarantine. We also calculated the risk if that proportion were to reach 100%, although in practice, this is unrealistic. Nevertheless, although we cannot predict accurately what that proportion would be, we expect the proportion of animals successfully vaccinated to be higher under the future new system(see paragraph 10.2.10).
10.1.13 Many cats and dogs in the EU are routinely vaccinated, regardless of their owners intentions to travel abroad. Vaccine manufacturers estimate that between 35-45% of dogs in the EU are vaccinated and around 12% of cats. These figures include data from countries that are rabies-free. Not surprisingly, in countries with endemic rabies, the vaccination rates in dogs are higher. In Germany, the EU country recording the greatest number of rabies cases during 1997, 58-65% of dogs were vaccinated. In France, 37-47% of dogs are vaccinated. This suggests that, even with no attempt at compliance with the proposed import regulations, dogs from rabies endemic countries are likely to be vaccinated at levels close to the lowest assumptions in this risk assessment. Cats are less significant in terms of risk. The survey carried out for us revealed that cats are less likely to be taken on holiday than dogs (cats are taken on 14% of holidays rather than 88% in the case of dogs).
10.2 Results
10.2.1 Here we focus on the principal findings. We begin by identifying the risks which arise under the present system of quarantine and then examine the various alternative approaches. Initially we considered the effect of the different options were there to be no change in the numbers of animals imported.
Option (a): Present System of Quarantine
10.2.2 We considered first the expected average interval between each case of rabies in an animal (either a cat or a dog) imported into Great Britain under the present system. Figure A shows the outcome of 1,000 simulations. The most likely interval between each case of rabies in an imported animal outside quarantine at current volumes of imports (the mode or peak of the distribution) is 36 years, with a wide range of 21-87 years. This represents an annual risk of 0.027 cases per year or one case in 324,000 animals.
10.2.3 If we assume that owners importing animals from different regions of the world all have the same tendency to put their animals into quarantine rather than smuggle them, only 0.6% of the total risk can be attributed to animals coming from the EU. The annual risk associated with cats and dogs coming from this region is thus 0.6% of 0.027/year, or one rabies-infected animal every 6,200 years. If EU cat and dog owners are more inclined than average to put their animals into quarantine then clearly the risk would be still lower. Working with such low risks, it would be impossible ever to test this result directly. However, these figures arise as the logical consequence of the best available data on the constituent elements of risk and risk-protection.
Option (b): Reduced Quarantine Period
10.2.4 In considering the length of quarantine to be risk assessed, we could, of course, have chosen any period of time between one day and one day short of the present period of six months. We chose one month because that seemed to us to be a period for which owners might be prepared to tolerate quarantining their animal. Indeed, many animals are housed in catteries and kennels for such periods each year as their owners take holidays. However, reducing the quarantine period to one month rather than six months increases the risk of rabies entering Great Britain even with the current volume of imports. The interval between rabies entries would fall to 18 (10, 39) years, and the risk would be 140 (77, 150)% greater than at present. The risk is likely to be higher than it is now even if 100% of cats and dogs were quarantined under this option(Table 10.1).
Option (c): Vaccination, Identification, Serological Testing
10.2.5 For convenience, we sub-divided option (c) into five sub-options. Firstly, to understand the essential differences between option (c) and the present system, we assumed that all animals are vaccinated and serologically tested six months prior to entering Great Britain (option c0). The fraction vaccinated was assumed to be the same as the fraction quarantined for six months at present. The proportion of animals checked at the port of entry was also taken to be the same. (All other variables are assigned the values in Table A.10.2)
10.2.6 In option (c0), the risk of a case of rabies is 2 (1, 7)% higher than under the present policy. This is a marginal increase, especially when set against the uncertainty associated with the present quarantine system.
Table 10.1 - summary of results from the risk analysis.
| POLICY | Effect | Assumptions | relative risk % change compared with present best (low, high) | absolute risk years between rabies entries best (low, high) | ||
| Volume of traffic (animals/year) | Proportion vaccinated (%) | Other proportion quarantined (%) | ||||
| Current system (option (a)a) | Six months quarantine all imported animals | 8194 (7267,12901) | 0 | Current proportion of animals quarantined | 0 | 36 (21,87) |
| Current system (option (a)b) | Six months quarantine all imported animals | 8194 (7267,12901) | 0 | 100% quarantined | -67 (-89,-8) | 91 (63, 253) |
| Option (b)a | One month quarantine all imported animals | 8194 (7267,12901) | 0 | Current proportion of animals quarantined | 140 (77,150) | 18 (10,39) |
| Option (b)b | One month quarantine all imported animals | 8194 (7267,12901) | 0 | 100% quarantined and all illegal imports rejected or placed in quarantine | 69 (-27,370) | 25 (13,45) |
| Option (c0) | Animals microchipped, vaccinated, blood tested. All animals would qualify. | 8194 (7267,12901) | 89 (56, 100) | 2 (1,7) | 32 (20,78) | |
| Option (c1) | Animals microchipped, vaccinated, blood tested. Only animals from GB + rabies-free islands qualify (six months quarantine for remainder) | 168194 (87267, 252901) |
89 (56,100) | 2 (1,7) | 32 (21,78) | |
| Option (c2)a | Animals microchipped, vaccinated, blood tested. Animals from EU (including GB) + rabies-free islands qualify (six months quarantine for remainder) | 245129 (124549,368076) | 89 (56, 100) | 11 (3,28) | 28 (19,71) | |
| Option (c2)b | Animals microchipped, vaccinated, blood tested. Animals from EU (including GB) + rabies-free islands qualify (six months quarantine for remainder) | 245129 (124549,368076) | 100 | 4 (0,11) | 34 (20,77) | |
| Option (c2)c | Animals microchipped, vaccinated, blood tested. Animals from EU (including GB) + rabies-free islands qualify (six months quarantine for remainder) | 245129 (124549,368076) | 89 (56,100) | Assumes 100% checked on entry and all illegal imports rejected or placed in quarantine | 3 (0,9) | 34 (20,81) |
| Option (c2)d | Animals microchipped, vaccinated, blood tested. Animals from EU (including GB) + rabies-free islands qualify (six months quarantine for remainder) | 245129 (124549,368076) |
89 (56, 100) | Assumes that the blood test is twelve months pre-entry | 10 (2,25) | 27 (20,71) |
| Option (c2)e | Animals microchipped, vaccinated, blood tested. Animals from EU (including GB) + rabies-free islands qualify (six months quarantine for remainder) |
245129 (124549,368076) |
100 |
100% checked, blood tests six months pre-entry |
3 (0,9) |
34 (20,81) |
| Option (c2)f | Animals microchipped, vaccinated, blood tested. Animals from EU (including GB) + rabies-free islands qualify (six months quarantine for remainder) | 245129 (124549,368076) |
89 (56, 100) | Assumes that rabies has been eradicated from the EU | 0 | 36(21,87) |
| Option (c3) | Animals microchipped, vaccinated, blood tested. Animals from EU + rabies-free islands + North America would qualify (six months quarantine for remainder) | 247284 (126460,371469) | 89 (56,100) | 12 (4,32) | 25 (19,71) | |
| Option (c4)a | Animals microchipped, vaccinated, blood tested. All animals would qualify (six months quarantine for remainder) | 250258 (129098,376152) |
89 (56,100) | 81 (64,106) | 18 (11,43) | |
| Option (c4)b | Animals microchipped, vaccinated, blood tested. All animals would qualify | 250258 (129098,376152) |
100 | -34 (-55, -7) | 43 (31, 125) | |
| None | No quarantine, no vaccination |
8194 (7267,12901) | 0 | 215 (169,329) | 10 (7,24) | |
| Mixed option (b+c2a) | Mixed policy Animals from EU (including GB) + rabies-free islands qualify (six months quarantine for remainder) |
245129 (124549,368076) | 89 (56, 100) | 10 (3,26) | 27 (18,67) | |
| Option (d) | Animals microchipped, vaccinated, blood tested. Animals from EU (including GB) + rabies-free islands qualify (six months quarantine for remainder) | 8194 (7267,12901) | 89 (56,100) | 100% checked away from ports and all illegal imports rejected or placed in quarantine. | 3 (0,9) | 34 (20,81) |
| Option (e) | No quarantine. Animals microchipped, vaccinated, blood tested. All animals would qualify | 250258 (129098,376152) |
89 (56, 100) | 81 (64,106) | 18 (11,43) | |
| Option (f) | No quarantine. Animals microchipped, vaccinated, blood tested. All animals would qualify | 250258 (129098,376152) |
Imported animals=89 (56,100). But assumes 100% GB cats and dogs vaccinated |
78 (62,102) |
15 (12,46) |
|
| Relative risk: as compared with present policy; negative numbers indicate a fall in risk, positive numbers indicate an increase in risk. Absolute risk: years between a case in a cat or dog free in GB | ||||||
10.2.7 The difference between the two systems, small as it is, is entirely attributable to the fact that vaccination simply does not protect all animals against infection. Given a vaccine that theoretically protects 100% of uninfected animals, the relative risk of the entry of an animal with rabies under (c0), as compared with the present system, falls to one (i.e. no difference in risk).
Expected impact of more imported animals under option (c)
10.2.8 Any move to a system based on option (c), in almost any form, is likely to lead to an increase in the number of animals imported into Great Britain. This rise in animal traffic will cause a change in risk, likely to depend on the geographical areas to which the policy is applied. We now consider four sub-options of (c), applied respectively: (c1) to British cats and dogs travelling to and from the EU, plus imported animals from rabies-free islands; (c2) to all imported animals from the EU and rabies-free islands (including itinerant British animals); (c3) to all imported animals from rabies-free islands, the EU and North America; or (c4) irrespective of country of origin.
10.2.9 The estimated changes in relative risk, compared with the present system are, respectively, 2%, 11%, 12% and 81% greater than at present (see Table A). Most of the uncertainty associated with these estimates is due to variation in the proportion of households which might take their animals on holiday. Other variables of lesser significance have been ignored. In general, the risk will be greater when more animals are imported and when the system is applied less selectively.
Reducing the risks under option (c)
10.2.10 The only practical ways at present to make option (c) better than the present system are to extend the pre-entry period , to ensure that a greater fraction of animals is vaccinated than is now quarantined, or to subject a greater fraction of animals to checks at ports of entry. We will now consider the last two of these.
10.2.11 The calculations described thus far have assumed that compliance will be the same under option (c), i.e. that the fraction of cats and dogs vaccinated would be the same as the fraction now quarantined. In fact, however, it is reasonable to suppose that compliance might improve under a changed policy: a larger fraction of cats and dogs would be vaccinated if owners perceive the new arrangements to be easier and cheaper overall than quarantine.
10.2.12 Both vaccination and checking reduce risk. For example, if we assume that all animals are vaccinated, then the resulting risk would be almost the same as if all animals were checked on arrival. If all imported cats and dogs were vaccinated and shown by means of a blood test to have a sufficient antibody titre six months prior to entry, then the risk of a case of rabies under option (c2) would be 4% higher than at present (this increase in risk is due to the increased numbers of animals imported and the fact that not all vaccinated animals are protected)(Table A). If all imported animals were checked at ports of entry (i.e. all non-compliant animals detected), the risk of a case of rabies would be 3% higher than at present. However, if the proportion of animals vaccinated or checked fell below 100%, then vaccination is seen to be more effective in reducing risk.
Option (d)
10.2.13 Under this alternative, the conditions of option (c) apply, except that animals would be checked away from the port of entry. The same degree of risk would result where the proportion of animals checked is the same.
Option (e)
10.2.14 This variation removes quarantine altogether (see Table A.10.1). Abandoning quarantine has two implications. First, all animals failing to satisfy the requirements of option (c) would be re-exported, which would lower the risk, or be smuggled into the country, which would increase the risk. Most significant is the inference that, without any quarantine facilities, the vaccination, identification and testing policy would be applied unselectively, to animals from all countries. This would lead to a large increase in risk (Table 10.1).
Option (f)
10.2.15 Option (f) is similar to (e), but requires that all cats and dogs in Great Britain are vaccinated. This would also produce a large increase in risk (Table 10.1), but less than under option(e).
No Quarantine, No Vaccination
10.2.16 It is, of course, possible to have no policy at all concerning the import of animals. The most likely interval between cases of rabies among all imported animals entering Great Britain, were there to be no quarantine and no vaccination (and also no increase in numbers imported), is 10 (7, 24) years, an annual risk of 0.1 (0.042, 0.143). This risk is 215 (169, 329)% higher than under the present quarantine system (Table A).
Mixed Policy: (b) plus (c2)
10.2.17 The combination of options (b) and (c2) is bound to be safer than (c2) alone. But the extra requirement of quarantine for one month would not have much effect on risk: compared with the present policy, the chance of a rabies entry would increase by 10% rather than 11% (Table A).
Risk to Humans10.2.18 We can estimate the risk of a human case of rabies in Great Britain by matching the number of indigenous human cases with the number of cases in cats and dogs in any selected region of the world. Over the period 1977-88, indigenously acquired rabies was recorded in 71 people and 24,632 cats and dogs throughout Europe. This would suggest that for every 1,000 animal cases we could expect there to be 2.9 human cases. 390 Thus, for one animal case every 28-34 years under option (c2), we would expect one human case every 9,700-11,700 years. This is probably an overestimate of the risk to humans for two reasons. First, animal cases are less likely to be recorded than human cases. Second, most of the human cases over this period were in Eastern Europe (especially Turkey), where people are perhaps less likely to receive post-exposure treatment following an animal bite. On the other hand, when rabies is newly imported into a country, people might not initially seek post-exposure prophylaxis.
Absolute versus Relative Risk10.2.19 Throughout our risk assessment, much emphasis has been placed on relative risk. For example, options (c1) - (c3) all increase somewhat the risk of a rabies entry into Great Britain, as compared with six months' quarantine. We must stress, however, that these are marginal increases to the present very low risk. Under (c2), for example, our best estimate of the absolute risk is one case in 28-34 years (depending on the degree of vaccination and checking achieved), instead of one case in 36 years. Because of the uncertainties inherent in the data, the ranges of possible risks under (c2) and the present system are almost completely overlapping: 19-71 years under (c2) as compared with 21-87 years under six months' quarantine (Table A). In this sense, the absolute risk under (c2) is not significantly different from the absolute risk under the present system.
Conclusions
10.3.1 On the basis of the risk analysis and other scientific evidence (notably the effectiveness of inactivated and adjuvanted vaccines, confirmatory evidence of immunity that is provided by blood tests carried out to demonstrate protection for at least six months prior to entry into Great Britain, and the reliability of microchip identification), we believe that a requirement for imported cats and dogs animals to undergo six months' quarantine can no longer be sustained as regards animals entering Great Britain from the EU, EEA and rabies-free islands, having been resident in those places, and as regards animals resident in Great Britain returning after having been taken abroad to these countries. EU and EEA Member States, and rabies-free islands, are referred to elsewhere in this Chapter as the "qualifying countries".
10.3.2 The incubation period for rabies in some animals may be longer than six months. This, combined with the risk that an animal infected with rabies may be smuggled into Great Britain, indicates that the existing system is not risk-free. Our risk assessment shows that the risk of a cat or dog developing rabies outside quarantine under the existing arrangements is one case in every 36 years, with a range from 21 to 87 years.
10.3.3 We compared the risk associated with the current quarantine system with the risk arising from the other options set out in our terms of reference, plus two additional ones. The option of having no system of control at all, with animals freely allowed to enter Great Britain without restriction, was analysed to provide a measure against which to judge the others. As might be expected, there would be a significant risk that rabies would be introduced into Great Britain, with at least one case being expected in every ten years (range from seven to 24 years).
10.3.4 Reducing the period of quarantine to one month would also be likely to increase significantly the risk that rabies would be introduced, even if it were possible to ensure that every animal entering the country is quarantined. Those options involving the complete abolition of quarantine (but not of all controls) also showed a significant increase in risk. We concluded, therefore, that none of these options should be pursued further.
10.3.5 We considered the impact of extending the pre-entry period to twelve months, but this alone, in the absence of improved rates of vaccination and therefore protection against rabies, had little significant impact on the relative risk. We considered that this increased burden was disproportionate to the reduction in risk and we have not considered it further.
10.3.6 We also considered the risks arising from a mixed policy of requiring all imported rabies-susceptible mammals to be quarantined for one month, but only those that have been resident outside qualifying countries and (as regards cats and dogs) those that have not been satisfactorily identified by microchip, vaccinated and blood tested, would be required to complete six months in quarantine. The risks involved are greater than those posed by the existing quarantine arrangements, but of the same order as the option in which the requirement for one month's quarantine is not included. We conclude, therefore, that insistence on a requirement for one months quarantine, in addition to microchipping, vaccination and blood testing, would be disproportionate to the risk of importing rabies from such animals.
10.3.7 We found (Table 10.1) that if animals from any country were to be allowed into Great Britain, subject to being satisfactorily identified by microchip, vaccinated and blood tested, the risk is in fact reduced compared to quarantine, provided there was 100% compliance amongst animal owners. Unfortunately, we are not convinced that this would be possible, given the difficulties of ensuring proper certification in some parts of the world. We conclude, therefore, that only animals from qualifying countries should be given exemption from quarantine.
10.3.8 Our risk assessment also shows that a system allowing certain animals to be exempt from quarantine, subject to certain conditions, could be introduced which, statistically, would pose only a very marginally greater risk than the present system of quarantine. It is this new system which we now consider.
10.4 The Proposed New System
10.4.1 Animals exempt from quarantine would be cats and dogs arriving in Great Britain that had been resident for at least six months in an EU or EEA Member State, or a rabies-free island. Cats and dogs which are resident in Great Britain and which had travelled to these countries would also qualify on their return to Great Britain. We have not attempted to define those islands that might be considered to be rabies-free. We are satisfied instead to rely on the definition of rabies-free used by the OIE. In our view, this is sufficiently strict that animals from any islands which meet this definition could safely be exempted from quarantine.
10.4.2 The risk assessment shows that cats and dogs from North America could also be included within the proposed new system with only a slight additional increase in risk. This conclusion is based on the assumption that few North American animals, in fact, would be brought to Great Britain. We assumed only a two-fold increase, on the basis that animals will be brought in by air and that most North American visitors, being tourists, would not choose to be accompanied by their animals. These assumptions may, however, be wrong and as rabies is both endemic and widespread in North America, we have concluded that cats and dogs from North America should not be included in the proposed new system, but that the position should be kept under review.
Conditions10.4.3 The conditions that would have to be met before any animal could be exempt from quarantine are that the animal has been certified as:
a) electronically identifiable having had an acceptable type of microchip implanted ;
b) vaccinated against rabies at or over three months of age using an inactivated and adjuvanted vaccine approved by the authorities of an EU Member State ;
c) having had a blood test, following vaccination against rabies, carried out at least six months before the entry of the animal into Great Britain. The blood test must have been performed in a laboratory approved by the British authorities, and must show a rabies antibody titre equal to or greater than 0.5 IU/ml. If the animal is imported more than twelve months after the vaccination that preceded the blood test, it must subsequently have been revaccinated annually or at such greater intervals as are in accordance with the conditions of authorisation of the vaccine ;
d) in cases where the animal has not been revaccinated at intervals in accordance with the conditions of authorisation of the vaccine, it must be revaccinated and a blood test carried out at least six months before entry. The blood test must have been carried out in a laboratory approved by the British authorities, and must have confirmed the presence of a rabies antibody titre equal to or greater than 0.5 IU/ml ;
e) having been treated no more than 24 hours before entry into or return to Great Britain with a preparation licensed for the treatment of ticks and an anthelmintic preparation that is authorised in an EU Member State, for the removal of Echinococcus multilocularis.
10.4.4 Animals of other species (excluding bats, and those caught in the wild) that had been resident in the same countries could also be exempted from quarantine .
10.4.5 All other cats and dogs, namely:
a) those that fail to meet the conditions above,
b) those that have not been resident in a qualifying country, and
c) British animals that have travelled outside the qualifying countries, would continue to be subject to six months quarantine on arrival in, or return to, Great Britain.
10.4.6 The proposed new system set out above presupposes that each imported animal would be checked at the port of entry (i.e. its microchip would be read, and its health certificate checked). All other factors being equal, we found that the risk of importing rabies is no different if animals are checked at the port of entry rather than at inland reception centres. We have been unable to find any evidence to suggest that the proportion of animals checked would be different under this option than under option (c). Under the principle of proportionality, as the inconvenience of checks at inland reception centres would be greater than checks at ports, with no increased benefit in terms of reduced risk, we conclude that checks should take place at the port of entry.
Nature of Risk10.4.7 Our proposed new system poses a marginal increase in risk compared to the current system of quarantine. This marginal increase could be made even smaller by making the new system itself more effective. This would involve increasing both the proportion of animals that have been successfully vaccinated against rabies, and the proportion of those whose documents are checked on entry. The difference in risk between the new system and the existing system of quarantine could only be completely eliminated if rabies were to be eradicated from the EU. That said, we are anxious to reaffirm that what we are considering here are very small statistical increases in very small risks. In addition, while we regard the risk assessment as a crucial part of our deliberations, it has not entirely determined what we recommend, which flows additionally from our considerations of scientific developments and the feasibility of effective implementation of our proposed system. In particular, we approached the findings of the Risk Assessment against the background of ever-increasing scientific understanding and development.
Staging
10.4.8 We considered whether to recommend that the new system be introduced in stages. The advantages of introducing change in stages would inter alia be to enable (a) staff and public to adapt gradually to the new system and (b) to iron out any problems before the full impact of the change was felt. This would obviate the difficulties that we were told had occurred in Sweden, where considerable administrative and operational difficulties occurred in the period after change was introduced. It would also allow for a period of national and international education, and enable the British Government to engage in negotiations to develop an EC initiative for harmonised controls of the import of cats and dogs using the British model.
10.4.9 Staging would, however, bring a number of disadvantages. The most important of these is legal. EU law forbids discrimination between Member States, other than for the protection of human or animal health. Any measures taken for this protection must be proportionate to the risk. With the differences in risk between animals from the British Isles, rabies-free islands and the Continental EU countries being so slight, it would be difficult to claim that staging, which discriminated against countries in the Continental EU, was proportionate to the risk.
10.4.10 Secondly, the most obvious first stage (allowing British animals to travel to and from other EU countries without being quarantined), would probably account for some two-thirds of the expected traffic. Change on this scale could hardly be considered to be a plausible form of staging. Indeed, it would defeat the proposed purpose of staging. We conclude, therefore, that the proposed new system should not be introduced in stages.
10.4.11 Instead, we recommend that changes to the present system should not be introduced until an administrative and operational infrastructure is in place. We recommend that a sufficiently long period be allowed before introduction of the proposed new system, for example, three years, to allow, inter alia, for enforcement staff to be recruited and trained, the public to be properly informed, computer systems to be put in place, and for sites at ports to be rented and (possibly) buildings constructed. We recommend, furthermore, that whenever the proposed new system is put into force, it be introduced on a date outside the peak holiday period. We recommend additionally that, once it is put into force, appropriate monitoring systems be put in place to ensure that problems are identified and resolved.
10.5 The EU Dimension
10.5.1 Our concern throughout this Report has been with the risk of importing rabies into Great Britain. In making recommendations, however, we must also take account of the implications for any proposed new system which membership of the EU may have. In particular, we need to take account of EU law and policy concerning the creation of a single EU market, reflected, for example, in the removal of barriers to the free movement of goods and people within the EU.
10.5.2 The first point to notice is that the current system of quarantine is seen by some as being in breach of EU law. The barrier against importing pet animals, guide dogs etc. can be regarded as a restriction on the free movement of goods and, in the case of those who choose not to subject their animals to quarantine on entering or re-entering Great Britain, a restriction on the free movement of persons. The fact that the current system of quarantine remains in place is explained, on this approach, as being a concession. The sensitivity of Great Britain to the issue of rabies is, it is said, well understood, such that action to harmonise the approach to rabies on an EU basis has not yet been pressed. EU proposals for harmonisation may well, however, be brought forward should Great Britain not adjust its position.
10.5.3 There may, of course, be plausible responses to the claim that Great Britain's quarantine system breaches EU law. Pet animals need not be categorised as "goods". Indeed, it could be said that the existence of the Balai arrangements reinforces this view, by expressly introducing a parallel, non-quarantine system for trade in animals, i.e. what a market in goods is concerned with. Perhaps the strongest counter-argument, however, lies in the doctrine of proportionality: that local, national variations in legal arrangements may be tolerated to the extent that they are proportionate to the perceived need. In the case of quarantine, the argument goes that the maintenance of Great Britain as a rabies-free island, given the presence of rabies in the EU, with the consequent avoidance of the risk to animal and human health which rabies represents, justifies a departure from the non-quarantine system practised between other Member States.
10.5.4 The question which immediately arises, of course, is whether quarantine is proportionate to the risk, or whether some less restrictive policy could achieve the desired result, (i.e. the maintenance of rabies-free status) without deviating from what may be otherwise applicable EU law. The risk assessment which we carried out must be our principal guide on this matter. When the new arrangements were introduced in Sweden in 1994, quarantine was abandoned, but a system of border controls was retained similar to the system which we recommend. There would be a disproportionate risk associated with moving at a stroke to a system which has no national system of controls.
10.5.5While we recognise these various legal arguments, we do not wish to make recommendations which depend for their acceptability on technical legal issues. We appreciate that the recommendations we make must conform to Great Britain's obligations under the Treaty of Rome and not run the risk of legal challenge. To take account of the EU dimension, therefore, we propose that our recommendations be taken forward in the following manner:
a) that the Minister introduce the proposed new system specifically and explicitly as a transitional system, and
b) that the Minister simultaneously seek to promote a harmonised EU system of controls against rabies which will reflect the concerns and meet the needs identified in our Recommendations.
10.5.6 In support of this approach, we draw attention to the following:
a) our risk assessment makes it clear that a system of checking, such as the one which we recommend, is currently essential to prevent an increase in the risk of importing rabies. Checking is necessary to enable the British authorities to be satisfied that an animal arriving in Great Britain meets the conditions set;
b) it has also been suggested to us that, in keeping with the principle of the European Single Market, checks should take place before an animal departs for Great Britain. We believe that many owners would not comply with a requirement that their animal's documents be checked under these circumstances. After all, such a condition would only be required by British law. As our risk assessment has clearly identified, the lower the proportion of animals whose documentation is checked, the greater the risk of importing rabies;
c) there is no EU-wide system currently in force to ensure that the kind of control measures against rabies which we regard as essential are observed in the other EU Member States from which pet animals, guide dogs etc. might enter or return. It has also been argued that allowing animals to enter Great Britain from the Continental EU might encourage the smuggling of animals that do not qualify, through the use of false documentation. We have considered this possibility, but have been unable to assess the risk that rabies might be introduced into Great Britain by this route as data on the potential for such activity is, by its nature, difficult to obtain, therefore, we recommend that compliance with the new system be kept under review;
d) there is no EU-wide system in force to prevent the import of other diseases currently not present in Great Britain, in particular Echinococcus multilocularis ;
e) as a consequence of the above, the balance of proportionality lies in favour of Great Britain's introducing a system of controls against rabies based on our recommendations. This system should be seen as a transitional arrangement until such time as an EU-wide system can be put in place;
f) the evidence of our risk assessment shows that the balance of proportionality will continue to lie in favour of the proposed new system until rabies is eradicated from the EU;
10.5.7 We recognise that in any EU harmonised system, our reliance on a system of checks at points of entry may not be acceptable to some Member States as the basis of long-term policy, not least because they have removed such border controls and would not be willing to reinstate them for this particular purpose. To that extent, what we recommend may not, in its entirety, serve as a template for EU action. Furthermore, the rejection of border controls by some would conflict with what Great Britain will already have introduced as transitional arrangements, if our recommendations are accepted. We recognise that, in any harmonised EU system, reliance on a system of checks at points of entry may not be acceptable to all Member States. We recommend that, until rabies has been effectively eradicated from the EU and appropriate EU-wide measures put in place in respect of animals to be imported from third countries where rabies is endemic (including the candidate countries of Eastern Europe), the Minister should, if necessary, seek a derogation from a harmonised EU system to allow checks to take place at British points of entry. Once rabies has been effectively eradicated from the EU and appropriate EU-wide measures put in place in respect of animals to be imported from third countries where rabies is endemic (including candidate countries from Eastern Europe) , the need for a British based system of checks will disappear. It is to this extent that what we propose should be understood as transitional.
10.5.8 We recommend, further, that in any EU harmonised system, adequate controls be put in place against importing rabies from countries outside the EU, including those in Eastern Europe, which are candidates to join the EU. We recommend that such controls involve a period in quarantine for rabies-susceptible mammals arriving from rabies-endemic countries. We recommend that the views of the European Commission Scientific Veterinary Committee proposing a period of only four months for quarantine should not be adopted as the basis for the development of a harmonised policy, until a thorough assessment of the risk of introducing rabies posed by stipulating such a period has been carried out, given the relatively high proportion of animals that can incubate the disease for more than four months.
10.5.9 We would make one final point. Our recommendations propose the partial dismantling of the system of quarantine. We contemplate that it be done in a measured and cautious manner, but pursuant to a clear timetable. There is no doubt that expectations will be raised among the public. If the view is taken that changes are on the way, it is likely that the current quarantine system will continue to be observed. If, however, it appears that the only change to the current system can, for legal-political reasons, be on an EU-wide basis, the current absence of such an EU system and the length of time it would take to introduce one, would put very significant pressure on the current system of quarantine. The very real danger exists that it could fall into disrepute, that smuggling would increase considerably and that, as a consequence, the risk of introducing rabies would rise significantly. It is for this, in addition to the other points which we have made, that we commend our recommendations to the Ministers.
10.6 Recommendations
10.6.1 Cats and Dogs1. We therefore recommend that certain cats and dogs that are resident in Great Britain be exempt from quarantine on return from another EU or EEA Member State or a rabies-free island. Such cats and dogs would be those that are certified as:
a) electronically identifiable, having had an acceptable type of microchip implanted;
b) vaccinated against rabies at or over three months of age using an inactivated and adjuvanted vaccine approved by the authorities of an EU Member State;
c) having had a blood test, following vaccination against rabies, carried out at least six months before the re-entry of the animal to Great Britain;
d) having been treated no more than 24 hours before return to Great Britain with a preparation licensed for the treatment of ticks and with an anthelmintic preparation that is authorised in an EU Member State, for the removal of Echinococcus multilocularis.
In order to qualify for exemption, the blood test must have been performed in a laboratory approved by the British authorities, and must show a rabies antibody titre equal to or greater than 0.5 IU/ml. If the animal is imported more than twelve months after the vaccination that preceded the blood test, it must subsequently have been revaccinated annually or at such greater intervals as are in accordance with the conditions of authorisation of the vaccine. Animals should be checked at the port of entry on arrival in Great Britain from outside the British Isles, and their identification and health certificate confirmed to be in order. In cases where the animal has not been revaccinated at intervals in accordance with the conditions of authorisation of the vaccine, it must be revaccinated and a blood test taken at least six months before entry. The blood test must have been carried out in a laboratory approved by the British authorities, and must have confirmed the presence of a rabies antibody titre equal to or greater than 0.5 IU/ml.
2. We recommend that cats and dogs which have been resident for at least six months in one or more EU or EEA Member States (except the Republic of Ireland), or a rabies-free island, which:
a) meet the conditions set out in Recommendation 1; and
b) have been checked on entry to Great Britain from outside the British Isles and their identification and health certificate confirmed to be in order;
should be permitted entry into Great Britain, without having to be subject to quarantine.
3. We recommend that the definition of rabies-free island used by the OIE should be adopted.
4. Provided that equivalent rabies control policies continue to apply throughout the British Isles, we recommend that, in recognition of the special status of Northern Ireland, the Republic of Ireland, the Isle of Man and the Channel Islands in current British legislation, animals resident in these islands, Northern Ireland and the Republic of Ireland should continue to have unrestricted access to Great Britain.
5. We recommend that all imported cats and dogs from countries other than qualifying countries should remain subject to six months quarantine on arrival in, or return to, Great Britain.
6. We recommend that the Minister commissions a further study of the numbers of cats and dogs which might be brought into Great Britain from North America if the current quarantine system were not applied and carry out a risk assessment in the light of the results of such a study.
7. We recommend that any cat or dog presented at a checkpoint which does not meet the conditions set out in Recommendations 1 or 2, should either be placed in quarantine for six months, or until it can be demonstrated that it does meet the required conditions, or be required to be re-exported.
Page last modified: January 20, 2006