The Czech Republic submitted a request to the European Commission to be recognised as a Member State with negligible risk of classical scrapie. EFSA has been asked to assess if the Czech Republic in ...its application has demonstrated for a period of at least 7 years (2015–2021) and proposed for the future, that a sufficient number of ovine and caprine animals over 18 months of age, representative of slaughtered, culled or found dead on farm animals, have been and will continue to be tested annually to provide a 95% level of confidence of detecting classical scrapie if it is present in that population at a prevalence rate exceeding 0.1%. A risk‐based approach using stochastic scenario‐tree modelling accounting for surveillance stream and species was applied. There is still a lack of data on the actual performance of the approved tests under field conditions, especially in sheep. Therefore, alternative scenarios were explored extending the range from the sensitivity provided by the past European Union evaluations of diagnostic screening tests to a sensitivity of 50%, consistent with published data obtained under field conditions in infected goat populations. Using data provided by the Czech Republic for 2015–2022, the estimated parameters of the scenario‐tree model, the range of values of diagnostic sensitivity and applying the criterion for the 95% confidence level, it is concluded that the Czech Republic has tested annually a sufficient number of small ruminants to meet the requirement, for all combinations of years and diagnostic sensitivity scenarios except for 60% diagnostic sensitivity in 2021 and 2022, and 50% in 2015, 2016 and 2018–2022. Based on the proposed number of samples to be tested in 2023 and future years, the Czech Republic would test a sufficient number of animals to meet the requirement for all combinations of diagnostic sensitivity, except for the 50% scenario.
The European Commission asked EFSA whether the scientific data on the 2‐year intensified monitoring in atypical scrapie (AS) outbreaks (2013–2020) provide any evidence on the contagiousness of AS, ...and whether they added any new knowledge on the epidemiology of AS. An ad hoc data set from intensified monitoring in 22 countries with index case/s of AS in sheep and/or goats (742 flocks from 20 countries, 76 herds from 11 countries) was analysed. No secondary cases were confirmed in goat herds, while 35 secondary cases were confirmed in 28 sheep flocks from eight countries. The results of the calculated design prevalence and of a model simulation indicated that the intensified monitoring had limited ability to detect AS, with no difference between countries with or without secondary cases. A regression model showed an increased, but not statistically significant, prevalence (adjusted by surveillance stream) of secondary cases in infected flocks compared with that of index cases in the non‐infected flocks (general population). A simulation model of within‐flock transmission, comparing a contagious (i.e. transmissible between animals under natural conditions) with a non‐contagious scenario, produced a better fit of the observed data with the non‐contagious scenario, in which each sheep in a flock had the same probability of developing AS in the first year of life. Based on the analyses performed, and considering uncertainties and data limitations, it was concluded that there is no new evidence that AS can be transmitted between animals under natural conditions, and it is considered more likely (subjective probability range 50–66%) that AS is a non‐contagious, rather than a contagious disease. The analysis of the data of the EU intensified monitoring in atypical scrapie infected flocks/herds confirmed some of the known epidemiological features of AS but identified that major knowledge gaps still remain.
Two alternative methods for producing compost in a tunnel, from certain category (Cat.) 3 animal by‐products (ABP) and other non‐ABP material, were assessed. The first method proposed a minimum ...temperature of 55°C for 72 h and the second 60°C for 48 h, both with a maximum particle size of 200 mm. The assessment of the Panel on Biological Hazards (BIOHAZ) exclusively focused on Cat. 3 ABP materials (catering waste and processed foodstuffs of animal origin no longer intended for human consumption). The proposed composting processes were evaluated for their efficacy to achieve a reduction of at least 5 log10 of Enterococcus faecalis and Salmonella Senftenberg (775W, H2S negative) and at least 3 log10 of relevant thermoresistant viruses. The applicant provided a list of biological hazards that may enter the composting process and selected parvoviruses as the indicator of the thermoresistant viruses. The evidence provided by the applicant included: (a) literature data on thermal inactivation of biological hazards; (b) results from validation studies on the reduction of E. faecalis, Salmonella Senftenberg 775W H2S negative and canine parvovirus carried out in composting plants across Europe; (c) and experimental data from direct measurements of reduction of infectivity of murine parvovirus in compost material applying the time/temperature conditions of the two alternative methods. The evidence provided showed the capacity of the proposed alternative methods to reduce E. faecalis and Salmonella Senftenberg 775W H2S negative by at least 5 log10, and parvoviruses by at least 3 log10. The BIOHAZ Panel concluded that the two alternative methods under assessment can be considered to be equivalent to the processing method currently approved in the Commission Regulation (EU) No 142/2011.
Update on chronic wasting disease (CWD) III Koutsoumanis, Kostas; Allende, Ana; Alvarez‐Ordoňez, Avelino ...
EFSA journal,
November 2019, Letnik:
17, Številka:
11
Journal Article
Recenzirano
Odprti dostop
The European Commission asked EFSA for a Scientific Opinion: to revise the state of knowledge about the differences between the chronic wasting disease (CWD) strains found in North America (NA) and ...Europe and within Europe; to review new scientific evidence on the zoonotic potential of CWD and to provide recommendations to address the potential risks and to identify risk factors for the spread of CWD in the European Union. Full characterisation of European isolates is being pursued, whereas most NA CWD isolates have not been characterised in this way. The differing surveillance programmes in these continents result in biases in the types of cases that can be detected. Preliminary data support the contention that the CWD strains identified in Europe and NA are different and suggest the presence of strain diversity in European cervids. Current data do not allow any conclusion on the implications of strain diversity on transmissibility, pathogenesis or prevalence. Available data do not allow any conclusion on the zoonotic potential of NA or European CWD isolates. The risk of CWD to humans through consumption of meat cannot be directly assessed. At individual level, consumers of meat, meat products and offal derived from CWD‐infected cervids will be exposed to the CWD agent(s). Measures to reduce human dietary exposure could be applied, but exclusion from the food chain of whole carcasses of infected animals would be required to eliminate exposure. Based on NA experiences, all the risk factors identified for the spread of CWD may be associated with animals accumulating infectivity in both the peripheral tissues and the central nervous system. A subset of risk factors is relevant for infected animals without involvement of peripheral tissues. All the risk factors should be taken into account due to the potential co‐localisation of animals presenting with different disease phenotypes.
An alternative method for the production of renewable fuels from rendered animal fats (pretreated using methods 1–5 or method 7 as described in Annex IV of Commission Regulation (EC) No 2011/142) and ...used cooking oils, derived from Category 3 animal by‐products, was assessed. The method is based on a catalytic co‐processing hydrotreatment using a middle distillate followed by a stripping step. The materials must be submitted to a pressure of at least 60 bars and a temperature of at least 270°C for at least 4.7 min. The application focuses on the demonstration of the level of reduction of spores from non‐pathogenic spore‐forming indicator bacterial species (Bacillus subtilis and Desulfotomaculum kuznetsovii), based on a non‐systematic review of published data and additional extrapolation analyses. The EFSA BIOHAZ Panel considers that the application and supporting literature contain sufficient evidence that the proposed alternative method can achieve a reduction of at least 5 log10 in the spores of B. subtilis and a 12 log10 reduction in the spores of C. botulinum. The alternative method under evaluation is considered at least equivalent to the processing methods currently approved in the Commission Regulation (EU) No 2011/142.
An assessment was conducted on the level of inactivation of relevant pathogens that could be present in processed animal protein of porcine origin intended to feed poultry and aquaculture animals ...when methods 2 to 5 and method 7, as detailed in Regulation (EU) No 142/2011, are applied. Five approved scenarios were selected for method 7. Salmonella Senftenberg, Enterococcus faecalis, spores of Clostridium perfringens and parvoviruses were shortlisted as target indicators. Inactivation parameters for these indicators were extracted from extensive literature search and a recent EFSA scientific opinion. An adapted Bigelow model was fitted to retrieved data to estimate the probability that methods 2 to 5, in coincidental and consecutive modes, and the five scenarios of method 7 are able to achieve a 5 log10 and a 3 log10 reduction of bacterial indicators and parvoviruses, respectively. Spores of C. perfringens were the indicator with the lowest probability of achieving the target reduction by methods 2 to 5, in coincidental and consecutive mode, and by the five considered scenarios of method 7. An expert knowledge elicitation was conducted to estimate the certainty of achieving a 5 log10 reduction of spores of C. perfringens considering the results of the model and additional evidence. A 5 log10 reduction of C. perfringens spores was judged: 99–100% certain for methods 2 and 3 in coincidental mode; 98–100% certain for method 7 scenario 3; 80–99% certain for method 5 in coincidental mode; 66–100% certain for method 4 in coincidental mode and for method 7 scenarios 4 and 5; 25–75% certain for method 7 scenario 2; and 0–5% certain for method 7 scenario 1. Higher certainty is expected for methods 2 to 5 in consecutive mode compared to coincidental mode.
This report of EFSA presents the results of surveillance activities on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep and goats as well as genotyping data in sheep, carried ...out in 2015 in the EU and in three non‐Member States (non‐MS). Since 2001, approximately 114 million cattle in the EU have been tested for bovine spongiform encephalopathy (BSE) according Regulation (EC) 999/2001. In 2015, 1.4 million bovine animals were tested and five cases were detected in four MS (Ireland: one case; Slovenia: one case; Spain: one case; and the United Kingdom: two cases) and one case was detected in Norway. Two cases (in Ireland and the United Kingdom) were affected by classical BSE and both cases were born after the EU‐wide feed ban enforced in 2001. The remaining four cases were atypical BSE cases (three H‐BSE type and one L‐BSE type). Since 2002, approximately 8.4 million small ruminants have been tested during the EU‐wide surveillance for scrapie. In 2015, 319,638 sheep and 135,857 goats were tested. In total, 641 scrapie cases in sheep were detected in 18 MS while 1,052 scrapie cases in goats were detected in nine MS, respectively. In two non‐MS (Iceland and Norway), 40 scrapie cases in sheep were detected. Although in a number of MS the decrease in classical scrapie is clear, at the EU level there is no clear decreasing trend in the occurrence of scrapie in small ruminants. Results obtained from genotyping in sheep confirm that cases of classical scrapie are clustered among certain genotypes, and animals with these genotypes seem to account for less than 20% of the European randomly sampled sheep population. In total, 580 samples from species other than domestic ruminants were tested for TSE in three MS, all with negative results.
A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity ...for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission to animals and humans. The combined probability of exposure and subsequent LPAIV infection via raw poultry meat containing LPAIV is negligible for commercial poultry and humans exposed via consumption whereas it is very unlikely for non‐commercial poultry, wild birds and humans exposed via handling and manipulation. The probability of LPAIV transmission from an individual infected via raw poultry meat containing LPAIV is negligible for commercial poultry and humans, whereas it is very unlikely for non‐commercial poultry and wild birds. The combined probability of exposure and subsequent LPAIV infection via raw table eggs containing LPAIV is negligible for commercial poultry and humans and extremely unlikely to negligible for non‐commercial poultry and wild birds. The probability of LPAIV transmission from an individual infected via raw table eggs containing LPAIV is negligible for commercial poultry and humans and very unlikely to negligible for non‐commercial poultry and wild birds. Although the presence of LPAIV in raw poultry meat and table eggs is very unlikely to negligible, there is in general a high level of uncertainty on the estimation of the subsequent probabilities of key steps of the transmission pathways for poultry and wild birds, mainly due to the limited number of studies available, for instance on the viral load required to infect a bird via raw poultry meat or raw table eggs containing LPAIV.
EFSA was requested to estimate the cattle bovine spongiform encephalopathy (BSE) risk (C‐, L‐ and H‐BSE) posed by ruminant collagen and gelatine produced from raw material fit for human consumption, ...or from material classified as Category 3 animal by‐products (ABP), to be used in feed intended for non‐ruminant animals, including aquaculture animals. Three risk pathways (RP) were identified by which cattle could be exposed to ruminant feed cross‐contaminated with ruminant collagen or gelatine: 1) recycled former foodstuffs produced in accordance with Regulation (EC) No 853/2004 (RP1), 2) technological or nutritional additives or 3) compound feed, produced either in accordance with Regulation (EC) No 853/2004 (RP2a) or Regulation (EU) No 142/2011 (RP2b). A probabilistic model was developed to estimate the BSE infectivity load measured in cattle oral ID50 (CoID50)/kg, in the gelatine produced from the bones and hide of one infected animal older than 30 months with clinical BSE (worst‐case scenario). The amount of BSE infectivity (50th percentile estimate) in a member state (MS) with negligible risk status was 7.6 × 10–2 CoID50/kg, and 3.1 × 10–4 CoID50/kg in a MS with controlled risk status. The assessment considered the potential contamination pathways and the model results (including uncertainties) regarding the current epidemiological situation in the EU and current statutory controls. Given the estimated amount of BSE infectivity to which cattle would be exposed in a single year, and even if all the estimated undetected BSE cases in the EU were used for the production of collagen or gelatine (either using raw materials fit for human consumption or Category 3 ABP raw materials), it was concluded that the probability that no new case of BSE in the cattle population would be generated through any of the three RP is 99–100% (almost certain).
The European Commission requested EFSA to assess if different thermal processes achieve a 5 log10 reduction in Enterococcus faecalis or Salmonella Senftenberg (775W) and (if relevant) a 3 log10 ...reduction in thermoresistant viruses (e.g. Parvovirus) as well as if different chemical processes achieve a 3 log10 reduction of eggs of Ascaris sp., in eight groups of Category 2 and 3 derived products and animal by‐products (ABP). These included (1) ash derived from incineration, co‐incineration and combustion; (2) glycerine derived from the production of biodiesel and renewable fuels; (3) other materials derived from the production of biodiesel and renewable fuels; (4) hides and skins; (5) wool and hair; (6) feathers and down; (7) pig bristles; and (8) horns, horn products, hooves and hoof products. Data on the presence of viral hazards and on thermal and chemical inactivation of the targeted indicator microorganisms and biological hazards under relevant processing conditions were extracted via extensive literature searches. The evidence was assessed via expert knowledge elicitation. The certainty that the required log10 reductions in the most resistant indicator microorganisms or biological hazards will be achieved for each of the eight groups of materials mentioned above by the thermal and/or chemical processes was (1) 99–100% for the two processes assessed; (2) 98–100% in Category 2 ABP, at least 90–99% in Category 3 ABP; (3) 90–99% in Category 2 ABP; at least 66–90% in Category 3 ABP; (4) 10–66% and 33–66%; (5) 1–33% and 10–50%; (6) 66–90%; (7) 33–66% and 50–95%; (8) 66–95%, respectively. Data generation on the occurrence and reduction of biological hazards by thermal and/or chemical methods in these materials and on the characterisation of the usage pathways of ABP as organic fertilisers/soil improvers is recommended.
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