ABSTRACT
The European Commission asked EFSA for a scientific opinion on chronic wasting disease in two parts. Part one, on surveillance, animal health risk-based measures and public health risks, was published in January 2017. This opinion (part two) addresses the remaining Terms of Reference, namely, 'are the conclusions and recommendations in the EFSA opinion of June 2004 on diagnostic methods for chronic wasting disease still valid? If not, an update should be provided', and 'update the conclusions of the 2010 EFSA opinion on the results of the European Union survey on chronic wasting disease in cervids, as regards its occurrence in the cervid population in the European Union'. Data on the performance of authorised rapid tests in North America are not comprehensive, and are more limited than those available for the tests approved for statutory transmissible spongiform encephalopathies surveillance applications in cattle and sheep. There are no data directly comparing available rapid test performances in cervids. The experience in Norway shows that the Bio-Rad TeSeE™ SAP test, immunohistochemistry and western blotting have detected reindeer, moose and red deer cases. It was shown that testing both brainstem and lymphoid tissue from each animal increases the surveillance sensitivity. Shortcomings in the previous EU survey limited the reliability of inferences that could be made about the potential disease occurrence in Europe. Subsequently, testing activity in Europe was low, until the detection of the disease in Norway, triggering substantial testing efforts in that country. Available data neither support nor refute the conclusion that chronic wasting disease does not occur widely in the EU and do not preclude the possibility that the disease was present in Europe before the survey was conducted. It appears plausible that chronic wasting disease could have become established in Norway more than a decade ago.
ABSTRACT
EFSA received an application from the Dutch Competent Authority, under Article 20 of Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011, for the evaluation of an alternative method for treatment of Category 3 animal by-products (ABP). It consists of the hydrolysis of the material to short-carbon chains, resulting in medium-chain fatty acids that may contain up to 1% hydrolysed protein, for use in animal feed. A physical process, with ultrafiltration followed by nanofiltration to remove hazards, is also used. Process efficacy has been evaluated based on the ability of the membrane barriers to retain potential biological hazards present. Small viruses passing the ultrafiltration membrane will be retained at the nanofiltration step, which represents a Critical Control Point (CCP) in the process. This step requires the Applicant to validate and provide certification for the specific use of the nanofiltration membranes used. Continuous monitoring and membrane integrity tests should be included as control measures in the HACCP plan. The ultrafiltration and nanofiltration techniques are able to remove particles of the size of virus, bacteria and parasites from liquids. If used under controlled and appropriate conditions, the processing methods proposed should reduce the risk in the end product to a degree which is at least equivalent to that achieved with the processing standards laid down in the Regulation for Category 3 material. The possible presence of small bacterial toxins produced during the fermentation steps cannot be avoided by the nanofiltration step and this hazard should be controlled by a CCP elsewhere in the process. The limitations specified in the current legislation and any future modifications in relation to the end use of the product also apply to this alternative process, and no hydrolysed protein of ruminant origin (except ruminant hides and skins) can be included in feed for farmed animals or for aquaculture.
ABSTRACT
EFSA was requested: to assess the impact of a proposed quantitative real-time polymerase chain reaction (qPCR) 'technical zero' on the limit of detection of official controls for constituents of ruminant origin in feed, to review and update the 2011 QRA, and to estimate the cattle bovine spongiform encephalopathy (BSE) risk posed by the contamination of feed with BSE-infected bovine-derived processed animal protein (PAP), should pig PAP be re-authorised in poultry feed and vice versa, using both light microscopy and ruminant qPCR methods, and action limits of 100, 150, 200, 250 and 300 DNA copies. The current qPCR cannot discriminate between legitimately added bovine material and unauthorised contamination, or determine if any detected ruminant material is associated with BSE infectivity. The sensitivity of the surveillance for the detection of material of ruminant origin in feed is currently limited due to the heterogeneous distribution of the material, practicalities of sampling and test performance. A 'technical zero' will further reduce it. The updated model estimated a total BSE infectivity four times lower than that estimated in 2011, with less than one new case of BSE expected to arise each year. In the hypothetical scenario of a whole carcass of an infected cow entering the feed chain without any removal of specified risk material (SRM) or reduction of BSE infectivity via rendering, up to four new cases of BSE could be expected at the upper 95th percentile. A second model estimated that at least half of the feed containing material of ruminant origin will not be detected or removed from the feed chain, if an interpretation cut-off point of 100 DNA copies or more is applied. If the probability of a contaminated feed sample increased to 5%, with an interpretation cut-off point of 300 DNA copies, there would be a fourfold increase in the proportion of all produced feed that is contaminated but not detected.
ABSTRACT
EFSA was requested to: 1) assess the risk for the development of antimicrobial resistance (AMR) due to feeding on farm of calves with colostrum potentially containing residues of antibiotics; 2) assess the risk for the development of AMR due to feeding on farm of calves with milk of cows treated during lactation with an antibiotic and milked during the withdrawal period, and 3) propose possible options to mitigate the risk for the development of AMR derived from such practices. Treatment of dairy cows during the dry period and during lactation is common in the EU Member States. Penicillins, alone or in combination with aminoglycosides, and cephalosporins are most commonly used. Residue levels of antimicrobials decrease with the length of the dry period. When the interval from the start of the drying-off treatment until calving is as long as or longer than the minimum specified in the Summary of Product Characteristics of the antimicrobial, faecal shedding of antimicrobial-resistant bacteria will not increase when calves are fed colostrum from treated cows. Milk from cows receiving antimicrobial treatment during lactation contains substantial residues during the treatment and withdrawal period. Consumption of such milk will lead to increased faecal shedding of antimicrobial-resistant bacteria by calves. A range of possible options exist for restricting the feeding of such milk to calves, which could be targeting the highest priority critically important antimicrobials. ß-Lactamases can reduce the concentration of ß-lactams which are the most frequently used antimicrobials in milking cows. Options to mitigate the presence of resistant bacteria in raw milk or colostrum are mainly based on thermal inactivation.
ABSTRACT
Sixty bovine spongiform encephalopathy (BSE) cases of Classical or unknown type (BARB-60 cases) were born after the date of entry into force of the EU total feed ban on 1 January 2001. The European Commission has requested EFSA to provide a scientific opinion on the most likely origin(s) of these BARB-60 cases; whether feeding with material contaminated with the BSE agent can be excluded as the origin of any of these cases and, if so, whether there is enough scientific evidence to conclude that such cases had a spontaneous origin. The source of infection cannot be ascertained at the individual level for any BSE case, including these BARB-60 cases, so uncertainty remains high about the origin of disease in each of these animals, but when compared with other biologically plausible sources of infection (maternal, environmental, genetic, iatrogenic), feed-borne exposure is the most likely. This exposure was apparently excluded for only one of these BARB-60 cases. However, there is considerable uncertainty associated with the data collected through the field investigation of these cases, due to a time span of several years between the potential exposure of the animal and the confirmation of disease, recall difficulty, and the general paucity of documented objective evidence available in the farms at the time of the investigation. Thus, feeding with material contaminated with the BSE agent cannot be excluded as the origin of any of the BARB-60 cases, nor is it possible to definitively attribute feed as the cause of any of the BARB-60 cases. A case of disease is classified as spontaneous by a process of elimination, excluding all other definable possibilities; with regard to the BARB-60 cases, it is not possible to conclude that any of them had a spontaneous origin.
ABSTRACT
Breeding programmes to promote resistance to classical scrapie, similar to those for sheep in existing transmissible spongiform encephalopathies (TSE) regulations, have not been established in goats. The European Commission requested a scientific opinion from EFSA on the current knowledge of genetic resistance to TSE in goats. An evaluation tool, which considers both the weight of evidence and strength of resistance to classical scrapie of alleles in the goat PRNP gene, was developed and applied to nine selected alleles of interest. Using the tool, the quality and certainty of the field and experimental data are considered robust enough to conclude that the K222, D146 and S146 alleles both confer genetic resistance against classical scrapie strains known to occur naturally in the EU goat population, with which they have been challenged both experimentally and under field conditions. The weight of evidence for K222 is greater than that currently available for the D146 and S146 alleles and for the ARR allele in sheep in 2001. Breeding for resistance can be an effective tool for controlling classical scrapie in goats and it could be an option available to member states, both at herd and population levels. There is insufficient evidence to assess the impact of K222, D146 and S146 alleles on susceptibility to atypical scrapie and bovine spongiform encephalopathy (BSE), or on health and production traits. These alleles are heterogeneously distributed across the EU Member States and goat breeds, but often at low frequencies (< 10%). Given these low frequencies, high selection pressure may have an adverse effect on genetic diversity so any breeding for resistance programmes should be developed at Member States, rather than EU level and their impact monitored, with particular attention to the potential for any negative impact in rare or small population breeds.
