Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): antimicrobial-resistant Brachyspira hyodysenteriae in swine

Abstract

Brachyspira hyodysenteriae (B. hyodysenteriae) was identified among the most relevant antimicrobial-resistant (AMR) bacteria in the EU for swine in a previous scientific opinion. Thus, it has been assessed according to the criteria of the Animal Health Law (AHL), in particular criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as in Article 9, and Article 8 for listing animal species related to the bacterium. The assessment has been performed following a methodology previously published. The outcome is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with uncertain outcome. According to the assessment here performed, it is uncertain whether AMR B. hyodysenteriae can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (33-66% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that the bacterium does not meet the criteria in Sections 1, 2 and 3 (Categories A, B and C; 1-10%, 10-33% and 10-33% probability of meeting the criteria, respectively) and the AHAW Panel was uncertain whether it meets the criteria in Sections 4 and 5 (Categories D and E, 50-90% and 33-66% probability of meeting the criteria, respectively). The main animal species to be listed for AMR B. hyodysenteriae according to Article 8 criteria are pigs and some species of birds, such as chickens and ducks.

Keywords: Animal Health Law; Brachyspira hyodysenteriae; antimicrobial resistance; categorisation; impact; listing.

Figure 1

Outcome of the expert judgement on Article 5 criteria and overall probability of AMR B. hyodysenteriae on its eligibility to be listed

1. Listing: The probability of the disease to be listed according to Article 5 criteria of the AHL (overall outcome).

Figure 2

Outcome of the expert judgement on criteria of Section 1 of Annex IV and overall probability of the AMR bacterium to be fitting in Category A of Article 9

1. Category A: the probability of the disease to be categorised according to Section 1 of Annex IV of the AHL (overall outcome).

Figure 3

Outcome of the expert judgement on criteria of Section 2 of Annex IV and overall probability of the AMR bacterium to be fitting in Category B of Article 9

1. Category B: the probability of the disease to be categorised according to Section 2 of Annex IV of the AHL (overall outcome).

Figure 4

Outcome of the expert judgement on criteria of Section 3 of Annex IV and overall probability of the AMR bacterium to be fitting in Category C of Article 9

1. Category C: the probability of the disease to be categorised according to Section 3 of Annex IV of the AHL (overall outcome).

Figure 5

Outcome of the expert judgement on criteria in Annex IV and overall probabilities for categorisation of the AMR bacterium in accordance with Article 9

Figure A.1 Individual probability ranges reflecting fulfilment of Criterion A(i) (the disease is transmissible) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.2 Individual probability ranges reflecting fulfilment of Criterion A(ii) (animal species are either susceptible to the disease or vectors and reservoirs thereof exist in the Union) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.3 Individual probability ranges reflecting fulfilment of Criterion A(iii) (the disease causes negative effects on animal health or poses a risk to public health due to its zoonotic character) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.4 Individual probability ranges reflecting fulfilment of Criterion A(iv) (diagnostic tools are available for the disease) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.5 Individual probability ranges reflecting fulfilment of Criterion B(i) (the disease causes or could cause significant negative effects in the Union on animal health, or poses or could pose a significant risk to public health due to its zoonotic character) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.6 Individual probability ranges reflecting fulfilment of Criterion B(ii) (the disease agent has developed resistance to treatments which poses a significant danger to public and/or animal health in the Union) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.7 Individual probability ranges reflecting fulfilment of Criterion B(iii) (the disease causes or could cause a significant negative economic impact affecting agriculture or aquaculture production in the Union) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.8 Individual probability ranges reflecting non‐fulfilment of Criterion B(iv) (the disease has the potential to generate a crisis or the disease agent could be used for the purpose of bioterrorism) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.9 Individual probability ranges reflecting non‐fulfilment of Criterion B(v) (the disease has or could have a significant negative impact on the environment, including biodiversity, of the Union) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.10 Individual probability ranges reflecting non‐fulfilment of Criterion 1A (the disease is not present in the territory of the Union or present only in exceptional cases (irregular introductions) or present in only in a very limited part of the territory of the Union) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.11 Individual probability ranges reflecting non‐fulfilment of Criterion 1B (the disease is present in the whole or part of the Union territory with an endemic character and (at the same time) several Member States or zones of the Union are free of the disease) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.12 Individual probability ranges reflecting fulfilment of Criterion 1C (the disease is present in the whole or part of the Union territory with an endemic character) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.13 Individual probability ranges reflecting non‐fulfilment of Criterion 2.1A (the disease is highly transmissible) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.14 Individual probability ranges reflecting fulfilment of Criterion 2.3A (the disease affects multiple species of kept and wild animals or single species of kept animals of economic importance) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.15 Individual probability ranges reflecting fulfilment of Criterion 2.4B (the disease may result in high morbidity with in general low mortality) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.16 Individual probability ranges reflecting non‐fulfilment of Criterion 2.4 C (the disease usually does not result in high morbidity and has negligible or no mortality and often the most observed effect of the disease is production loss) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.17 Individual probability ranges reflecting non‐fulfilment of Criterion 3A (the disease has a zoonotic potential with significant consequences for public health, including epidemic or pandemic potential or possible significant threats to food safety) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.18 Individual probability ranges reflecting non‐fulfilment of Criterion 3AB (the disease has a zoonotic potential with significant consequences for public health, including epidemic potential or possible significant threats to food safety) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.19 Individual probability ranges reflecting non‐fulfilment of Criterion 3ABC (the disease has a zoonotic potential with significant consequences for public health or possible significant threats to food safety) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.20 Individual probability ranges reflecting non‐fulfilment of Criterion 4AB (current impact) (the disease has a significant impact on the economy of the Union, causing substantial costs, mainly related to its direct impact on the health and productivity of animals) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.21 Individual probability ranges reflecting non‐fulfilment of Criterion 5(a) (current impact) (the disease has a significant impact on society, with in particular an impact on labour markets) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.22 Individual probability ranges reflecting non‐fulfilment of Criterion 5(a) (potential impact) (the disease has a significant impact on society, with in particular an impact on labour markets) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.23 Individual probability ranges reflecting fulfilment of Criterion 5(b) (current impact) (the disease has a significant impact on animal welfare, by causing suffering of large numbers of animals) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.24 Individual probability ranges reflecting fulfilment of Criterion 5(b) (potential impact) (the disease has a significant impact on animal welfare, by causing suffering of large numbers of animals) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.25 Individual probability ranges reflecting non‐fulfilment of Criterion 5(c) (current impact) (the disease has a significant impact on the environment, due to the direct impact of the disease or due to the measures taken to control it) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.26 Individual probability ranges reflecting non‐fulfilment of Criterion 5(c) (potential impact) (the disease has a significant impact on the environment, due to the direct impact of the disease or due to the measures taken to control it) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.27 Individual probability ranges reflecting non‐fulfilment of Criterion 5(d) (current impact) (the disease has a significant impact in the long term on biodiversity or the protection of endangered species or breeds, including the possible disappearance or long‐term damage to those species or breeds) after the collective judgement

1. The median range is displayed as a dashed line.

Figure A.28 Individual probability ranges reflecting non‐fulfilment of Criterion 5(d) (potential impact) (the disease has a significant impact in the long term on biodiversity or the protection of endangered species or breeds, including the possible disappearance or long‐term damage to those species or breeds) after the collective judgement

1. The median range is displayed as a dashed line.

Figure B.1 Individual probability ranges reflecting uncertain outcome on Criterion A(v) (risk‐mitigating measures and, where relevant, surveillance of the disease are effective and proportionate to the risks posed by the disease in the Union) after the collective judgement

1. The median range is displayed as a dashed line.

Figure B.2 Individual probability ranges reflecting uncertain outcome on Criterion 2.1BC (the disease is moderately to highly transmissible) after the collective judgement

1. The median range is displayed as a dashed line.

Figure B.3 Individual probability ranges reflecting uncertain outcome on Criterion 2.2AB (there are possibilities of airborne or waterborne or vector‐borne spread) after the collective judgement

1. The median range is displayed as a dashed line.

Figure B.4 Individual probability ranges reflecting uncertain outcome on Criterion 2.4A (the disease may result in high morbidity and significant mortality rates) after the collective judgement

1. The median range is displayed as a dashed line.

Figure B.5 Individual probability ranges reflecting uncertain outcome on Criterion 4AB (potential impact) (the disease has a significant impact on the economy of the Union, causing substantial costs, mainly related to its direct impact on the health and productivity of animals) after the collective judgement

1. The median range is displayed as a dashed line.

Figure B.6 Individual probability ranges reflecting uncertain outcome on Criterion 4C (current impact) (the disease has a significant impact on the economy of the Union, mainly related to its direct impact on certain types of animal production systems) after the collective judgement

1. The median range is displayed as a dashed line.

Figure B.7 Individual probability ranges reflecting uncertain outcome on Criterion 4C (potential impact) (the disease has a significant impact on the economy of the Union, mainly related to its direct impact on certain types of animal production systems) after the collective judgement

1. The median range is displayed as a dashed line.

Figure B.8 Individual probability ranges reflecting uncertain outcome on Criterion D (the risk posed by the disease can be effectively and proportionately mitigated by measures concerning movements of animals and products in order to prevent or limit its occurrence and spread) after the collective judgement

1. The median range is displayed as a dashed line.