Format for the multiannual survey programmes provided for in Article 23 of Regulation (EU) 2016/2031, and the practical arrangements for the application of the elements set out in that Article
ANNEX IISupplementary provisions
ANNEX II Format for the multiannual survey programmes provided for in Article 23 of Regulation (EU) 2016/2031, and the practical arrangements for the application of the elements set out in that Article PART I General information as referred to in point (a) of Article 2(2) 1. Template “General information for [years] — Member State: — Competent Authority: — Contact person (name, job held within the competent authority, organisation name, telephone number and functional email account): — Specific objective of each year of the multiannual survey programme (for more details, see point (a) in the section below, ‘Practical arrangements’): — Justification in accordance with Articles 22(1) and 24(1) of Regulation (EU) 2016/2031 in case of non-inclusion of certain Union quarantine pests, pests provisionally qualifying as Union quarantine pests or priority pests (on annual basis) in the multiannual survey programme (for more details, see point (b) in the section below, ‘Practical arrangements’): Pest Justification for non-inclusion in the multiannual survey programme — Methods of recording and reporting the information collected (for more details, see point (c) in the section below, ‘Practical arrangements’): — Summary provided by the Member State available for the general public (for publication on the Commission website, between 350- 2000 words) (for more details, see point (d) in the section below, ‘Practical arrangements’):” 2. Practical arrangements (a) Describe briefly and present reasoning for the distribution of the pests during the 5-7 years of the multiannual programme. (b) In accordance with Articles 22(1) and 24(1) of Regulation (EU) 2016/2031, provide justifications per pest not included in the multiannual survey programme. (c) In the information concerning the methods of recording and reporting the information collected include a brief description of the main methods used to carry out and report the surveys in the Member State territory. (d) In the summary provided for the general public include the following: — a short description and scope of the multiannual survey programme; — a short description of the methodology to be used for surveys, including any new or innovative technology (if relevant); — the total number of pests covered; — a link to the national competent authority’s website with more information (if available). PART II Templates for the multiannual survey programmes as referred to in point (b) of Article 2(2) 1. Elements of the multiannual survey programme concerning Union quarantine pests and pests subject to measures pursuant to Articles 29 and 30 of Regulation (EU) 2016/2031 in areas where those pests are not known to be present 1.1. Template ‘Multiannual survey programme for [years] concerning Union quarantine pests and pests subject to measures pursuant to Articles 29 and 30 of Regulation (EU) 2016/2031 in areas where the pests are not known to be present 1. Year 2. Pest surveyed in groups 3. Pest 4. Geographical location 5. Survey sites 6. Risk areas 7. Plant material/Commodity 8. List of plant species 9. Timing 10. Survey details: A) Number of visual examinations, per group B) Total number of samples C) Number of asymptomatic samples, when applicable D) Type of traps (or other alternative method (e.g. sweep nets)) E) Number of traps (other collecting method) F) Number of trapping sites (when different from data reported in (E)) G) Type of tests (e.g. microscopic identification, PCR, etc.) H) Number of tests I) Other measures (e.g. sniffer dogs, drones, helicopters, awareness raising campaigns etc.) J) Number of other measures 11. Comments Description Number A B C D E F G H I J Year 1 Group 1 - Authorised places of production Group 2 Year n Group 1- Authorised places of production Group 2 ’ 1.2. Practical arrangements For column 2: With the exception of the ‘Group 1 – Authorised places of production’, it is optional to plan the surveys per group of pests. When applicable, indicate the group of pests that will be surveyed together (e.g. citrus pests, deciduous forest pests, coniferous forest pests, cereal pests, potato pests, other (please specify)). In those cases when a pest will be included in several groups, please include in the programme the information for that pest accordingly in each group. For the ‘Group 1 – Authorised places of production’, indicate the list of pests for which surveys will be carried out, using more than one row when necessary to specify different survey sites of Column 5 ‘Survey sites’. In this group, please provide the data per pest, without aggregating at the group level. Authorised places of production are those places whose operator is authorised by the competent authority to issue plant passports. For column 3: Indicate the scientific name of the pest (as listed in Annex II of Implementing Regulation (EU) 2019/2072 or in any specific measure for a given pest), using one row per pest. For column 4: Indicate the geographical locations where the survey will take place, using preferably the lower NUTS levels available at this stage. In case of pest reported per group, it is possible to aggregate the data for all the pests in the group in one row. In case of pests not reported in groups, it is possible aggregate the data in one row per pest. It is also possible to use as many rows as number of locations reported, if appropriate. For column 5: Indicate the survey sites, using more than one row per pest when required by the specific legal pest survey requirements, and indicate the number of sites that will be surveyed. In case of pests reported per group, it is possible to aggregate the data for all the pests in the group in one row, and provide the total number of survey sites. In case of pests not reported in groups, it is possible to aggregate the data in one row per pest, and provide the total number of survey sites. When using the option ‘other’, please specify what it is: 1. Open air (production area): 1.1 field (arable, pasture); 1.2. orchard/vineyard; 1.3. nursery; 1.4. forest; 2. Open air (other): 2.1. private gardens; 2.2. public sites; 2.3. conservation area; 2.4. wild plants in areas other than conservation areas; 2.5. other, with specification of the particular case (e.g. garden centre, commercial sites that uses wood packaging material, wood industry, wetlands, irrigation and drainage network, etc.); 3. Physically closed conditions: 3.1. greenhouse; 3.2. private site, other than greenhouse; 3.3. public site, other than greenhouse; 3.4. other, with specification of the particular case (e.g. garden centre, commercial sites that uses wood packaging material, wood industry). For column 6: Optional or when applicable under specific legal pest survey requirements. Indicate the risk areas based on the biology of the pest(s), presence of host plants, eco-climatic conditions and risk locations. For column 7: Indicate plants, fruits, seeds, soil, packaging material, wood, machinery, vehicles, vector, water, other, specifying the specific case. When the specific legal pest survey requirement specifies the list of commodities to survey, the programme shall include the activities planned per commodity using different rows. For column 8: Indicate the list of plant species/genera that will be surveyed. When required by the specific pest legal survey requirement, the programme shall include the list of plant species/genera using a different row per each plant species/genus. For column 9: Indicate the months of the year when the surveys will be carried out. In case of pests reported per group, it is possible to aggregate the data for all pests in the group in one row. In case of pests not reported in groups, it is possible to aggregate the data in one row per pest. For column 10: Indicate the survey details, taking into account the specific legal requirements of each pest. Indicate with N/A when the information of certain column will not be available. It is only possible to aggregate the data from this column at the same level of the group of pests for the number of visual examinations. When required by the specific legal pest survey requirements, use different rows (e.g. the plan of using different types of tests and their number). 2. Elements of the multiannual survey programme concerning statistically based surveys for Union quarantine pests, and pests subject to measures pursuant to Articles 29 and 30 of Regulation (EU) 2016/2031, in areas where those pests are not known to be present, applicable when statistically based surveys will be carried out The multiannual survey programme shall summarise and justify the survey, including its input parameters, and the planned sampling effort 2.1. Template ‘Statistically based survey programme of [years] for Union quarantine pests and pests subject to measures pursuant to Articles 29 and 30 of Regulation (EU) 2016/2031, in areas where the pests are not known to be present 1. Year 2. Pest 3. Geographical location 4. Survey sites 5. Timing A. Survey definition (input parameters for RiBESS+) B. Sampling effort planned 19. Expected Confidence level 20. Design prevalence 21. Comments 6. Target population 7. Epidemiological units 8. Detection methods planned 9. Sampling effectiveness 10. Method sensitivity 11. Risk factors (activities, locations and areas) 12. N° of epidemiological units to be inspected 13. N° of examinations 14. N° of samples 15. N° of traps 16. N° of trapping sites 17. N° of tests 18. N° of other measures Host species Area (ha or other more relevant unit)) Number of inspection units Description Units Visual examinations Trapping Testing Other measures Risk factors Risk levels N° of locations Relative risks Proportion of the host plant population 1 N N ’ 2.2. Practical arrangements Explain the underlying assumptions for the survey design per pest. Summarise and justify: — The target population, epidemiological unit and inspection units — The detection method and method sensitivity — The risk factor(s), indicating the risk levels and corresponding relative risks and proportions of host plant population For column 2: Indicate the scientific name of the pest (as listed in Annex II of Implementing Regulation (EU) 2019/2072 or in any specific measure for a given pest). For column 3: Indicate the geographical locations where the survey will take place, using preferably the lower NUTS levels available. For column 4: Indicate the survey sites, using more than one row per pest when required by the specific legal pest survey requirements. Please, always plan the surveys to be carried out in Authorised places of production, in a different row. When using the option ‘other’, please specify what it is: 1. Open air (production area): 1.1 field (arable, pasture); 1.2. orchard/vineyard; 1.3. nursery; 1.4. forest; 2. Open air (other): 2.1. private gardens; 2.2. public sites; 2.3. conservation area; 2.4. wild plants in areas other than conservation areas; 2.5. other, with specification of the particular case (e.g. garden centre, commercial sites that uses wood packaging material, wood industry, wetlands, irrigation and drainage network, etc.); 3. Physically closed conditions: 3.1. greenhouse; 3.2. private site, other than greenhouse; 3.3. public site, other than greenhouse; 3.4. other, with specification of the particular case (e.g. garden centre, commercial sites that uses wood packaging material, wood industry). For column 5: Indicate the months of the year when the surveys will be carried out. For column 6: Indicate the chosen target population providing accordingly the list of host species and area covered. The target population is defined as the ensemble of inspection units. Its size is defined typically for agricultural areas as hectares, but could be lots, fields, greenhouses etc. Please justify the choice made in the underlying assumptions in column 21 (‘Comments’). Indicate the inspection units surveyed. ‘Inspection unit’ means plants, plant parts, commodities, materials, pest vectors that will be scrutinised for identifying and detecting the pests. If the area of the target population is not available, indicate N/A and include the number of inspection units that compose the target population. For column 7: Indicate the epidemiological units to be surveyed, indicating its description and unit of measurement. Epidemiological unit is defined as a homogeneous area where the interactions between the pest, the host plants and the abiotic and biotic factors and conditions would result into the same epidemiology, should the pest be present. The epidemiological units are a subdivision of the target population that are homogenous in terms of epidemiology with at least one host plant. In some cases the whole host plant population in a region/area/country might be defined as epidemiological unit. They could be NUTS regions, urban areas, forests, rose gardens or farms, or hectares. The choice shall be justified in the underlying assumptions. For column 8: Indicate the methods that will be used during the survey, including the number of activities in each case, depending on the specific legal pest survey requirements of each pest. Indicate with N/A when the information of certain column is not available. Indicate yes/no in Visual examinations and provide details of the methods for Trapping, Testing and Other measures. For column 9: Indicate an estimation of the sampling effectiveness. Sampling effectiveness means the probability of selecting infected plant parts from an infected plant. For vectors, it is the effectiveness of the method to capture a positive vector when it is present in the survey area. For soil, it is the effectiveness of selecting a soil sample containing the pest when the pest is present in the survey area. For column 10: ‘Method sensitivity’ is defined as the probability of a method to correctly detect pest presence. The method sensitivity is defined as the probability that a truly positive host is detected and confirmed positive and it is not misidentified. It is the multiplication of the sampling effectiveness (i.e. probability of selecting infected plant parts from an infected plant) by the diagnostic sensitivity (characterised by the visual examination and/or laboratory test used in the identification process). For column 11: Provide the risk factors in different rows, using as many rows as necessary. For each risk factor indicate the risk level and corresponding relative risk and proportion of host plant population. For column B: Indicate the number of activities planned, specifying the type of activity. Indicate with N/A when the information of certain column is not available. The information to be provided in these columns is related to the information included in the column 8 ‘Detection methods planned’. For column 16: Indicate the number of trapping sites in case this number differs from the number of traps (Column 15) (e.g. the same trap is used in different places). For column 20: Indicate the sensitivity of the survey, as defined in ISPM 31. This value of the achieved confidence level of pest freedom is calculated based on the examinations (and/or samples) performed given the method sensitivity and the design prevalence. For column 21: Indicate the design prevalence based on a pre-survey estimate of the likely actual prevalence of the pest in the field. The design prevalence is set as a goal of the survey and corresponds to the compromise the risk managers are making between the risk of having the pest and the resources available for the survey. Typically, for a detection survey a value of 1 % is set.