Ad hoc method for the assessment on listing and categorisation of animal diseases within the framework of the Animal Health Law

1.1 Background and Terms of Reference as provided by the requestor

Article 5 of the Regulation (EU) No 429/20161 of the European Parliament and of the Council on transmissible animal diseases (Animal Health Law), hereinafter referred as AHL, provides the list of animal diseases to which the rules set out in the AHL apply. These rules include the categorisation of those diseases into different groups depending on the appropriate measures, as provided for in Article 9 of that Regulation.

In addition to the list of five significant diseases laid down in Article 5 (1) of the AHL, there is a list of other diseases in Annex II that is amendable by the Commission by means of a delegated act.

Furthermore, there are transmissible animal diseases for which certain control or trade measures apply today but are not included in the mentioned Annex II and diseases that might be relevant for forthcoming Union intervention.

Criteria for listing of animal diseases are laid down in Article 5(3), for the assessment in Article 7 and for the categorisation of animal diseases in Annex IV of the AHL.

Those criteria constitute the benchmarks for the exercises of listing and categorisation and for determining the disease prevention and control rules to be applied to the different categories of listed diseases.

Furthermore, Article 8 of the AHL envisages that disease specific rules for listed diseases apply to listed animal species. Those species, or groups of animal species, are those that are either susceptible species or they have the capability to carry specific diseases.

Specific criteria for listing of species are provided for in Article 8(3) of the AHL.

The Commission needs a scientific advice to enable the assessment of the following diseases within the framework of the listing and categorisation according to the AHL, although the same methodology could be applied in the future for further request:

1. Aujeszky's disease
2. Enzootic bovine leukosis (EBL)
3. Bovine viral diarrhoea (BVD)
4. Infectious bovine rhinotracheitis (IBR)
5. Porcine reproductive and respiratory syndrome (PRRS)
6. Paratuberculosis
7. Koi herpes virus disease (KHV)
8. Anthrax
9. Infection with Brucella abortus, Brucella melitensis and Brucella suis
10. Japanese encephalitis
11. West Nile fever
12. Trypanosoma evansi infections (including Surra)
13. Equine encephalomyelitis (eastern and western)
14. Venezuelan equine encephalomyelitis
15. Borna disease
16. Bovine tuberculosis
17. Infection with low pathogenic avian influenza virus
18. Avian mycoplasmosis (Mycoplasma gallisepticum, Mycoplasma meleagridis)
19. Salmonella infection in poultry with serotypes of animal health relevance (Salmonella Pullorum, Salmonella Gallinarum and Salmonella arizonae)
20. Ebola
21. Bluetongue (all serotypes or group of serotypes)
22. Bovine genital campylobacteriosis
23. Trichomonosis
24. Border disease
25. Ovine epididymitis (Brucella ovis)
26. Contagious bovine pleuropneumonia
27. Contagious caprine pleuropneumonia
28. Infestation with Varroa spp. (Varroosis)
29. Batrachochytrium salamandrivorans (Bsal).

The criteria, provided in the Appendix A of this opinion, shall be used as a basis for the analytical assessment. The risk manager needs an updated scientific advice in order to:

• assess if the above mentioned animal diseases are diseases for which control measures at the European Union (EU) level are justified;
• proceed profiling each disease with a view to its categorisation;
• assign listed species to the diseases identified as relevant for the EU intervention.

In view of the above, and in accordance with Article 29 of Regulation (EC) No 178/2002, the Commission asks EFSA for a scientific opinion:

1. ToR 1: for each of the diseases an assessment, following the criteria laid down in Article 7 of the AHL, on its eligibility to be listed for Union intervention as laid down in Article 5(3) of the AHL.
2. ToR 2: for each of those diseases which was found eligible to be listed for Union intervention:
   1. an assessment of its compliance with each of the criteria in Annex IV to the AHL for the purpose of categorisation of diseases in accordance with Article 9 of the AHL;
   2. a list of animal species that should be considered candidates for listing in accordance with Article 8 of the AHL.

1.2 Interpretation of the Terms of Reference (ToR)

An assessment of the animal diseases listed in Section 1.1 according to the criteria of Articles 5, Annex IV for the purpose of categorisation of diseases in accordance with Article 92 and 8 of the AHL is requested by the European Commission in five similar mandates, to be done on the basis of the information available according to the assessment criteria of Article 7 (profile and impact). The criteria of Articles 5, 7, 8 and 9, are provided in the Appendix A of the present opinion.

The first ToR requires an assessment of each disease against the eligibility criteria as listed in Article 5. The Article 5 of the Regulation (EU) No 429/2016 provides the list of animal diseases to which the rules set out in the AHL apply. A disease is eligible to be listed if it has been assessed according to the criteria listed in Article 7 and if it meets the criteria of Article 5 of the AHL. The criteria of Article 7 concern the disease profile, impact of the disease, potential to generate a crisis situation and its potential for use in bioterrorism, the feasibility, availability, effectiveness and the impact of disease prevention and control measures.

The second ToR requires an assessment of each disease against the criteria as in Annex IV of the AHL for the purpose of categorisation of diseases in accordance with Article 9. These criteria provide the rules for the categorisation of the diseases into different groups depending on the appropriate measures (eradication, control, etc.), as provided for in Article 9 of the AHL. There are five categories in Article 9 of the AHL, each with a defined purpose as follows:

• category A: listed diseases that do not normally occur in the Union and for which immediate eradication measures must be taken as soon as they are detected.
• category B: listed diseases which must be controlled in all Member States with the goal of eradicating them throughout the Union.
• category C: listed diseases which are of relevance to some Member States and for which measures are needed to prevent them from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease concerned.
• category D: listed diseases for which measures are needed to prevent them from spreading on account of their entry into the Union or movements between Member States.
• category E: listed diseases for which there is a need for surveillance within the Union.

Each category foresees the application of certain disease prevention and control rules to the respective listed diseases when the disease in question fulfils the criteria laid down in the relevant Section of Annex IV of AHL (Sections 1–5 which correspond to categories A–E, respectively).

The same ToR requires the provision of the list of animal species that should be considered candidates for listing in accordance with Article 8(3). This Article envisages that specific rules for listed diseases apply to listed animal species. Those species, or groups of animal species, are those that are either susceptible species or those that have the capability to carry specific pathogenic agents.

For the first ToR, the disease and impact profile following Article 7 criteria requires compilation for each disease. This represents the baseline information for the assessment as requested by ToR 1 and ToR 2, i.e. to enable determination of the eligibility for listing the disease in the AHL, the category into which each of the diseases fits according to Article 9 of AHL, and the animal species that should be considered as relevant for that disease.

The use and the purpose of the assessment for the European Commission should be to provide clear and robust information to qualify the importance of each disease in the Union, and if justified, which measures should be taken in the EU.

The answer to the mandates will be structured in one document providing the description of the methodology for the assessment of diseases and an individual document providing the information and assessment for each disease.

2.1 Data collection for disease profile and impacts based on Article 7 criteria

In order to compile the information on (a) the diseases profile, (b, c) the impact of the diseases, (d) the availability, feasibility and effectiveness of control measures, and (e) the impact of disease prevention and control measures according to Article 7 of AHL,

• the Article 7 criteria (in Appendix A) are broken down and structured into parameters;
• data/information is collected at parameter level by selected disease scientists and drafted in a fact sheet format.

2.2 Use of Article 7 criteria and parameters to inform Articles 5, 8 and 9 criteria: mapping

As mentioned, the assessment of each disease, based on the criteria listed in Article 5 (eligibility for listing), should be performed on the basis of the information collected according to Article 7. For this purpose, a mapping is developed to identify which elements from Article 7 are needed to inform each Article 5 criterion. The table based on Article 7 criteria at parameter level (disease fact sheet) is used to build a matrix linking sets of relevant Article 7 parameters to each relevant criterion of Article 5.

Likewise, the assessment of the diseases in view of their categorisation based on Article 9, and of animal species that should be considered candidates for listing in accordance with Article 8 of the AHL are performed on the basis of the information collected under Article 7. In the same way, a similar mapping is developed to build a matrix linking sets of relevant Article 7 parameters to each relevant criterion of Article 9 and Article 8. For Article 8, the mapped Article 7 information constitutes directly the outcome of the assessment.

2.3 Disease assessment according to Article 5 and Article 9

The assessment of each disease according to Articles 5 and 9 criteria is carried out using the procedure of expert judgement that involves expert selection and judgement as described below.

3.1 Collection of information

At the commencement of the assessment of any disease, a disease scientist (DS) is selected as described in Section 2. The DS is provided with a template of a fact sheet to be completed following the framework determined from the structured Article 7 (input) (see Table 2). The result of breaking down the Article 7 criteria of the AHL into sub-criteria and parameters is given below in Table 2.

The DS collects information and drafts the disease fact sheet according to the criteria they have been provided (structured Article 7 criteria of the AHL).

The disease fact sheet is then reviewed by two independent reviewers (AHAW Panel experts or WG experts) and DS endorses the comments provided.

Input: Structured Article 7 (Table 2).

Output: Disease profile and impacts in a fact sheet format (Result for ToR 1).

3.2 Mapping of Article 7 criteria in relation to Article 5, Article 9 and Article 8 criteria

The disease fact sheet as in step 1 (structured table of Article 7 criteria) is reorganised using mapping matrices that allow assigning each set of information related to each Article 7 criteria (and related parameters) to the relevant Articles 5, 9 and 8 criteria. The mapping matrices providing each criterion of Articles 5, 9 and 8 as a function of Article 7 criteria (and related parameters) are given below in Tables 3, 4 and 5, respectively.

As a result, the disease fact sheet is reshaped into disease assessment table, an example is shown in Table 6 where the first question of Article 5 is reported, while, in Appendix B, the tables for all other questions are reported.

Output: Mapping matrices (Tables 3, 4 and 5) and a disease assessment table (Table 6). For Article 8, mapping of the disease fact sheet into Table 5 provides directly the outcome of the assessment.

In Appendix B, the instructions for the judgement including definitions and interpretations of terms and questions are provided.

3.3 Disease assessment

The disease assessment is performed using the ICBA approach as described in Section 2 on methodology. In the first round of judgement, the disease assessment table (Table 6) in step 2 is provided to experts (AHAW panel experts) for individual assessment of the disease. In the second round of judgement, the results of the expert judgement obtained in first round are used for the collective behavioural aggregation.

The final result of the expert judgement on each criterion of article 5 and article 9 is the output of the collective judgement, which combines the outcome of the individual judgements, their discussion and any additional relevant material known to the experts participating in the judgement. The final outcome can be revised by the AHAW Panel on the basis of any new available evidence before the adoption of the scientific opinion, and the judgment can be amended accordingly. The result of assessment is reported in Tables 7 and 8.

As from the legal text of the AHL, a disease is considered eligible to be listed as laid down in Article 5 if it fulfils all criteria indicated in point A and at least one criterion as in point B of Article 5(3) (see Appendix A.2). Likewise, a disease is considered to belong or classified in a category according to Article 9 if it fulfils all criteria indicated at points a and b and at least one of the criteria indicated at points c, d, e as in Annex IV (see Appendix A.3). According to the assessment methodology, a criterion is considered fulfilled when the outcome is ‘Yes’.

For each outcome without consensus, an additional table (Table 8) is provided followed by the detailed list of different supporting views.

For each disease, the final results of the assessment according to the assessment steps as shown in Figure 1 are the following:

• Disease fact sheet: provides information on the disease profile and impacts. The format is shown in Table 2.
• Disease assessment according to Article 5: it provides information on the eligibility of the disease to be listed. The format is shown in Tables 6 and 7.
• Disease assessment according to Article 9: it provides information on the compliance of the disease with each of the criteria in Annex IV to the AHL for the purpose of categorisation in accordance with Article 9. The format is shown in Tables 6 and 7.
• Disease assessment according to article 8: a list of animal species that should be considered candidates for listing in accordance with Article 8 of the AHL, based on the criteria as displayed in Table 5 of the present document.

The assessment results are drafted in a separated opinion, one for each disease.

A.1. Article 7 – Assessment parameters

The Commission shall use the following assessment parameters in order to determine whether a disease meets the conditions requiring it to be listed in accordance with Article 5(2):

1. the disease profile, which shall comprise the following:
   1. the animal species concerned by the disease;
   2. the morbidity and mortality rates of the disease in animal populations;
   3. the zoonotic character of the disease;
   4. the resistance to treatments, including antimicrobial resistance;
   5. the persistence of the disease in an animal population or in the environment;
   6. the routes and speed of transmission of the disease between animals and, when relevant, between animals and humans;
   7. the absence or presence and distribution of the disease in the Union, and, where the disease is not present in the Union, the risk of its introduction into the Union;
   8. the existence of diagnostic and disease control tools;
2. the impact of the disease on:
   1. agricultural and aquaculture production and other parts of the economy, as regards:
      • –  the level of presence of the disease in the Union;
      • –  the loss of production due to the disease;
      • –  other losses;
   2. human health, as regards:
      1. transmissibility between animals and humans;
      2. transmissibility between humans;
      3. the severity of human forms of the disease;
      4. the availability of effective prevention or medical treatment in humans;
   3. animal welfare;
   4. biodiversity and the environment;
3. its potential to generate a crisis situation and its potential use in bioterrorism;
4. the feasibility, availability and effectiveness of the following disease prevention and control measures:
   1. diagnostic tools and capacities;
   2. vaccination;
   3. medical treatments;
   4. biosecurity measures;
   5. restrictions on the movement of animals and products;
   6. killing of animals;
   7. disposal of carcasses and other relevant animal by-products;
5. the impact of disease prevention and control measures, as regards:
   1. the direct and indirect costs for the affected sectors and the economy as a whole;
   2. their societal acceptance;
   3. the welfare of affected subpopulations of kept and wild animals;
   4. the environment and biodiversity.

A.2. Article 5 – Criteria for listing of diseases

1. The disease-specific rules for the prevention and control of diseases provided for in this Regulation shall apply to:

1. the following listed diseases:
   1. foot and mouth disease;
   2. classical swine fever;
   3. African swine fever;
   4. highly pathogenic avian influenza;
   5. African horse sickness; and
2. the listed diseases set out in the list in Annex II.

2. The Commission shall adopt delegated acts in accordance with Article 264 concerning amendments to the list referred to in point (b) of paragraph 1 of this Article.

3. A disease shall be included on the list referred to in point (b) of paragraph 1 of this Article if it has been assessed in accordance with Article 7 and it meets:

1. all of the following criteria:
   1. scientific evidence indicates that the disease is transmissible;
   2. animal species are either susceptible to the disease or vectors and reservoirs thereof exist in the Union;
   3. the disease causes negative effects on animal health or poses a risk to public health due to its zoonotic character;
   4. diagnostic tools are available for the disease; and
   5. risk-mitigating measures and, where relevant, surveillance of the disease are effective and proportionate to the risks posed by the disease in the Union; and
2. at least one of the following criteria:
   1. 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;
   2. the disease agent has developed resistance to treatments which poses a significant danger to public and/or animal health in the Union;
   3. the disease causes or could cause a significant negative economic impact affecting agriculture or aquaculture production in the Union;
   4. the disease has the potential to generate a crisis or the disease agent could be used for the purpose of bioterrorism; or
   5. the disease has or could have a significant negative impact on the environment, including biodiversity, of the Union.

4. The Commission shall adopt delegated acts in accordance with Article 264 concerning the removal of a disease from the list referred to in point (b) of paragraph 1 of this Article when that disease no longer fulfils the criteria provided for in paragraph 3 of this Article.

5. The Commission shall review the listing of each disease in the light of newly available significant scientific data.

A.3. Annex IV – Criteria for the application of the disease prevention and control rules referred to in Article 9(1) to diseases listed in accordance with Article 5

The scope of this Annex is to detail the criteria to be considered by the Commission when determining the disease prevention and control rules to be applied to the different categories of diseases listed in accordance with Article 5.

The process of categorisation shall take into account the profile of the disease in question, the level of the impact of that disease on animal and public health, animal welfare and the economy, and the availability, feasibility and effectiveness of the diagnostic tools and different sets of disease prevention and control measures provided for in this Regulation with respect to the disease.

A.4. Article 8 – Listed species

Animal species or groups of animal species shall be added to the list if they are affected or if they pose a risk for the spread of a specific listed disease because:

1. they are susceptible to a specific listed disease or scientific evidence indicates that such susceptibility is likely; or
2. they are vector species or reservoirs for that disease, or scientific evidence indicates that such role is likely.

Here below the instructions for the judgement and, where needed, the interpretations of the questions is reported.

B.1. Instructions

All evidence provided by question should be read and considered when answering the question.

Sequence of the task for judging:

1. read the question, including any internal interpretation of this question
2. read the information/data
3. answer the question.

B.2. Interpretation of terms and questions

The following interpretations were considered for the assessment of criteria of Article 5 for listing and of Annex IV referring to categories of Article 9 of the AHL:

Interpretation of the term ‘significant’ when it is used in relation to the impact or the effect of the disease or of the disease control or preventive measure on animal health, public health, economy, society, environment:

A disease will be considered as having a significant impact on a system (animal health, public health, society, environment, economic) when it causes overall additional effects (damages, losses, costs, disturbance, …) compared to the situation in the absence of the disease either,

• at local scale (a single country for EU) but with long-term (> 1 year) effects
• at larger scale (> 2 countries) regardless the effect duration (short or long-terms)

or that require mitigation and control (authority) actions to restoring the system in its state in the absence of the disease.

Interpretation of questions in Article 5 B(i), B(iii) – ‘The disease causes or could cause …effect/impact…’ and B(v) – ‘The disease has or could have…impact…’:

• the disease impact or negative effects have to be assessed without considering any effect of interventions or control measures that are (if the disease is already present in the EU) or can be put in place (if the disease is exotic and assuming it is introduced into the EU).

All Article 9 criteria/questions refer to the EU regardless ‘in the Union’ is mentioned or not in the question.

Interpretation of questions in Article 9 2.4A, 2.4B – ‘The disease may result in high morbidity…’:

• For the judgment of this question, the potential for the disease to have high morbidity and/or high mortality even in absence of control measures are considered.

Interpretation of questions in Article 9 4AB, 4C, 5A, 5B, 5C, 5D starting with ‘the disease has a significant impact on…’:

• Case 1: if the disease is not present (exotic) or present only in exceptional cases, or only in a very limited part of EU:
  • —  Potential impact: Use the fact sheet and collective opinion to assess the impact of the disease assuming it is introduced into the EU and without considering the effects of any interventions or control measures.
• Case 2: if the disease is endemic/present in the whole or part of the Union
  • —  Current impact: Use the fact sheet (which provides information of the current status) and collective opinion to assess the impact of the disease by taking into account the effects of the interventions or control measures that are in place (if any);
  • —  Potential impact: when relevant, assess the impact of the disease considering the potential situation in EU as the interventions or control measures in place (if any) would be removed.

For the disease related to case 2 the different type of impact (current and potential, as explained above), is assessed separately in the table collecting the answers of the judges or explained in the reasoning points.

Interpretation of question D in Article 9 ‘the risk posed by the disease in question can be effectively and proportionately mitigated by measures concerning movements of animals and products in order to prevent or limit its occurrence and spread’: for exotic diseases, the assessment of the effectiveness of movement of animals and products to mitigate the risk should take into account also the control of movements into the EU (import checks).

For questions related to Article 9

The following interpretations were used for the assessment of the criteria across the categories A, B and C. If criterion 1 about disease distribution is fulfilled in category B, then the same available data would most likely also support fulfillment of category. For criterion 2.1 about transmissibility, the options in category B and C are the same. The criterion 2.2 is the same in category A and B, thus with same outcome. The criterion 2.3 in category B and C is considered always fulfilled, because a disease is dealt here if it affects at least one animal species. Criteria 5(a-d) are the same in category A, B and C and have the same outcome. The evidence extrapolated from the relevant criteria of Article 7 (fact sheet) should always support such interpretation.

B.3. Information provided to the experts for performing the assessment on each disease: information mapping

Here below all the example tables are reported, which show the criteria (questions) of Articles 5 and 9 next to the related criteria and parameters of Art. 7, based on which the judgement on each question should be performed.