| 1. |
- Vågsholm, Ivar
(författare)
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Scientific Opinion on assessment of epidemiological data in relation to the health risks resulting from the presence of parasites in wild caught fish from fishing grounds in the Baltic Sea
- 2011
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- For fishery products caught from fishing grounds in the Baltic Sea, four groups of viable parasites present possible health risks, Anisakis simplex (sensu stricto), Contracaecum osculatum (sensu stricto), Pseudoterranova decipiens (sensu stricto) and Diphyllobothrium spp. Since A. simplex and Pseudoterranova decipiens have been found in fishery products in International Council for the Exploration of the Sea (ICES) subdivisions 22, 23, 24, 25, 26, public health risks due to the presence of these parasites cannot be excluded in any fishery products caught from these areas. Migrating fish from areas where A. simplex, and to a lesser degree P. decipiens, occur may carry these parasites and reach the northern Baltic, therefore, public health risks due to parasites in all migrating fish (including salmon) in Baltic Sea cannot be excluded. C. osculatum occurs in fish throughout all areas of the Baltic Sea. However, at present it is not possible to assess the public health importance of viable C. osculatum larvae in fishery products. Diphyllobothrium spp. occurs in fish species in brackish waters of Baltic Sea. Hence all freshwater fish as well as migrating fish, including sea trout and whitefish, are of public health importance if consumed raw, since they may carry viable parasites. More research is needed to elucidate the importance of C. osculatum from fish as a source of human infection, including pathogenicity of this parasite and the anatomic distribution of the parasite in edible parts of the fish. In order to definitively identify species of anisakids, genetic/molecular methods should be more widely applied to material from all hosts of the Baltic Sea. Surveillance of anisakiasis and other parasitic infections in the human population in Baltic Sea countries should be improved
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| 2. |
- Vågsholm, Ivar
(författare)
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Scientific Opinion on Composting on-farm of dead poultry
- 2011
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- EFSA’s Scientific Panel on Biological Hazards (BIOHAZ) was asked for a scientific opinion on two alternative methods for processing Category (Cat) 2 Animal By-Products (ABP). The material to be treated consists of poultry manure, straw and dead-on-farm poultry; this implies that the animals died due to a disease, which in most cases was not properly diagnosed. The proposed processes are composting methods to be used on-farm. The first method is a continuous open system where composting is done under roof in piles separated by wooden partition walls. The piles are processed without enforced aeration. The second method is a discontinuous closed system consisting of two different types of containers (Box-Compost®) coupled with a device for conditioning temperature and humidity during composting (Compostronic®). The end-product obtained is intended to be used as an organic fertiliser. According to the legislation in force, before being used as an organic fertiliser, Cat. 2 material should be treated with a sterilisation process (i.e. 133°C / 20 min / 3 bars / 50 mm particle size). The BIOHAZ Panel concluded that the identification and characterisation of the risk material was not properly addressed in the application and a comprehensive list of possible hazards was not provided. No experimental validation with representative test-organisms under practical conditions was done. Because of a lack of information in the report, it was not possible to determine the degree of risk reduction of pathogenic bacterial, viral and parasitological agents achieved by the processes. Moreover, the proposed alternative method cannot be considered equivalent to the sterilisation process defined in the current legislation
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| 3. |
- Vågsholm, Ivar
(författare)
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Scientific Opinion on Isolation in proofed pit on-farm of dead poultry
- 2011
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- EFSA’s Scientific Panel on Biological Hazards (BIOHAZ) was asked for a scientific opinion on an alternative method for processing Category (Cat) 2 Animal By-Products (ABP) as defined in Reg. (EC) 1069/2009. The material to be treated consists of dead-on-farm poultry; this implies that the animals died due to a disease, which in most cases was not properly diagnosed. The proposed method consists in a decomposition of the carcasses by a process of autolysis, putrefaction and finally digestion by insects that takes place on-farm in a proofed pit. The carcasses are taken daily from a warehouse and immediately thrown into the pit. Lime is added at the rate of 200g/kg of carcass. Loading continues until the pit is full. The end-product obtained is intended to be used as an organic fertiliser. According to the legislation in force, before being used as an organic fertiliser, Cat. 2 material should be treated with a sterilisation process (i.e. 133°C / 20 min / 3 bars / 50 mm particle size). The BIOHAZ Panel concluded that the identification and characterisation of the risk material was not properly addressed in the application and a comprehensive list of possible hazards was not provided. No experimental validation with representative test-organisms under practical conditions was done. Because of a lack of information in the report, it was not possible to determine the degree of risk reduction of pathogenic bacterial, viral and parasitological agents achieved by the processes. Moreover, the proposed alternative method cannot be considered equivalent to the sterilisation process defined in the current legislation
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| 4. |
- Vågsholm, Ivar
(författare)
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Scientific Opinion on Lime Treatment of Solid Pig and Poultry Manure
- 2010
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 8
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Tidskriftsartikel (refereegranskat)abstract
- EFSA’s Scientific Panel on Biological Hazards (BIOHAZ) was asked for a scientific opinion on a novel process submitted by a European association as a safe means of disposal of Animal By-Products (ABP) according to Regulation (EC) 1774/20024. The application received describes a lime treatment process for dewatered pig and solid poultry manure which could be operated at two different temperatures (60°C and 70°C). The applicant carried out full scale trials for a batch process (i.e. stockpiles) utilizing quick lime (CaO) and demonstrated that the proposed process inactivated the relevant bacterial pathogens (Salmonella) and indicator (Enterococcus faecalis) by more than 5 log10 and the relevant virus and parasite eggs by more than 3 log10. The Panel concluded that the information provided by the applicant is sufficient to show that the mixing of dewatered pig and solid poultry manure with quicklime at the requested exposure time of 30 or 60 minutes, respectively for treatment at 70°C and 60°C at pH 12 meets the requirements for Agent Risk Reduction. However, it was highlighted that the assessment provided cannot be extended to different equipments, different types of manure and different incubation conditions than those used in the experimental validation. Moreover, the applicant did not give sufficient information to ascertain that in practice the target temperatures and pH are achieved in all part of the stockpile for the sufficient time period. The BIOHAZ Panel recommended that the proposed processes can be considered able to safely process dewatered pig and solid poultry manure only if certain given conditions are met
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| 5. |
- Vågsholm, Ivar
(författare)
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Scientific Opinion on On-site treatment of pig carcasses
- 2011
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- EFSA’s Scientific Panel on Biological Hazards (BIOHAZ) was asked for a scientific opinion on an alternative method for processing Category (Cat) 2 Animal By-Products (ABP). The materials to be treated are placentas and fallen pigs; this implies that the animals died due to a disease, which in most cases was not properly diagnosed. The target parameters are: i) particle size less than 150 mm and ii) heating for 10 – 12 hours at 100°C. The end-product obtained is mixed with pig slurry and used as an organic fertiliser. According to the legislation in force, before being used as an organic fertiliser, Cat. 2 material should be treated with a sterilisation process (i.e. 133°C / 20 min / 3 bars / 50 mm particle size). The most resistant hazards identified by the applicant as target to demonstrate the risk reduction are spores of pathogenic clostridia. Due to uncertainty on the cause of the animals’ death, the presence of more resistant hazards cannot be considered negligible. The sterilisation process defined in the current legislation is able to minimise the risks due to unidentified agents, such as Bacillus anthracis and TSE agents. The BIOHAZ Panel concluded that the process proposed was not properly validated experimentally under real scale conditions. In theory, it should permit a high degree of reduction of spores of pathogenic clostridia but because of several uncertainties (i.e. water evaporation, fat protective effect and particle size) it is not certain that the values of the parameters used in the theoretical calculations would apply in practice. Moreover, the proposed alternative method cannot be considered equivalent to the sterilisation process defined in the current legislation. This would be particularly relevant in the case of extremely heat resistant spores being present in the material to be treated
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| 6. |
- Vågsholm, Ivar
(författare)
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Scientific Opinion on the evaluation of a new processing method for ABP Category 2 materials of fish origin
- 2011
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- A new method for the treatment and disposal of Category 2 animal by-products (ABP’s) of fish origin according to Regulation (EC) 1774/2002 was assessed for the inactivation of the relevant biological hazards. It is proposed that the method will be used for the treatment of Category 2 fish material obtained from aquaculture plants. The proposed process technology consists of grinding fish raw material followed by acidification and heat treatment. The main steps of the proposed process are the mixing with formic acid, the storage for at least 24 hours at pH < 4, the heat treatment of the fish silage at a temperature ≥85°C for at least 25 minutes. It was concluded that, based on the results of the laboratory experiments, the risk related to pathogens present in fish ABPs from aquaculture would be adequately reduced by the proposed process, if the requirements of the HACCP plan are achieved. However, since there was no validation of the process in an existing plant, it is not possible to conclude on the feasibility of the given HACCP plan. It was further recommended that the full scale equipment should be designed in a way to permit validation by exposure to representative test organisms
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| 7. |
- Vågsholm, Ivar
(författare)
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Scientific Opinion on the maintenance of the list of QPS (qualified presumption of safety) biological agents intentionally added to food and feed (2010 update)
- 2010
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 8
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Tidskriftsartikel (refereegranskat)abstract
- EFSA is requested to assess the safety of a broad range of biological agents (including microorganisms and viruses) in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) concept was developed by EFSA for its own use to provide a generic risk assessment approach applicable across EFSA’s scientific Panels, for biological agents notified for intentional use in the whole food chain. The safety of unambiguously defined biological agents at the highest taxonomic unit that is appropriate for the purpose for which an application is intended are assessed, considering if the body of knowledge is sufficient. Identified safety concerns for a taxonomic unit could be reflected as ‘qualifications’ when considered appropriate for an inclusion on the QPS list. The list of QPS recommended biological agents is reviewed and updated annually. The 2010 update reviews the previously assessed microorganisms including bacteria, yeasts, filamentous fungi and viruses used for plant protection purposes. The recommendations of biological agents of the previous year were confirmed in the current update. Qualifications relating to the agents recommended for QPS were reviewed, clarified and updated where necessary. Specific sections dealing with antibiotic resistance relevant for QPS recommended microorganisms and yeast were included. The methodology used for carrying out the annual review of the list of QPS recommended biological agents was detailed. A list of microbial species from previous notifications and as notified to EFSA, annexed in this opinion, includes information on taxonomic units which are or are not recommended for the QPS list. This list of notifications aims to summarize and maintain important information for future assessments and updates
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| 8. |
- Vågsholm, Ivar
(författare)
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Scientific Opinion on the Neste Oil Application for a new alternative method of disposal or use of Animal By-Products
- 2010
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 8
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Tidskriftsartikel (refereegranskat)abstract
- EFSA’s Scientific Panel on Biological Hazards (BIOHAZ) was asked for a scientific opinion on a novel process developed by the Neste Oil Company as a safe means of disposal of animal by-products (ABP) according to Regulation (EC) 1774/2002. It is proposed that the method, known as the “Renewable Fuel” method, will be used for the treatment and disposal of Category 1 and Category 2 rendered animal fat obtained from animal byproducts that have been produced according to processing method 1 as referred to in Annex V, Chapter III of Commission Regulation (EC) 1774/2002 and for the treatment of Category 3 rendered animal fat that has been produced according to any of the processing methods 1 to 7 as referred to in the same Annex. The proposed process technology consists of a pre-treatment and of a continuous multiple step catalytic process. The main steps of interest for this assessment are called hydrodeoxygenation and isomerisation by the applicant. The production process can utilize a mixture of vegetable-oil and animal fat as feedstock. The Panel concluded that, in principle, the “Renewable Fuel” method may be appropriate for the safe destruction of BSE/TSE infectivity in animal waste. However, the company provided minimal data to support this conclusion (e.g. no quantitative estimate of the risk reduction level for Cat. 1 material was given). In the absence of such supporting data, the “Renewable Fuel” method cannot be considered safe for the treatment of such Category 1 wastes. The process proposed by Neste Oil can be considered to be safe for the treatment of Cat. 2 and 3 rendered animal fat since the input materials have already undergone a process ensuring adequate risk reduction
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| 9. |
- Vågsholm, Ivar
(författare)
-
Scientific Opinion on the results of the EU survey for Chronic Wasting Disease (CWD) in cervids
- 2010
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 8
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Tidskriftsartikel (refereegranskat)abstract
- The BIOHAZ Panel was asked to provide a scientific opinion drawing conclusions on the occurrence of CWD in the cervid population in the EU, based on the results of a survey set up by the European Commission and aimed at detecting the possible presence of CWD and other TSEs in wild and farmed cervids in the EU during years 2006 to 2010. The survey was designed taking into account recommendations from an earlier 2004 EFSA opinion and established the minimum sample size to be collected from wild and farmed red deer (Cervus elaphus elaphus) from a number of Member States and from wild white-tailed deer (Odocoileus virginianus) from Finland. It also required all Member States to collect additional samples from all cervid species. Overall, approximately 13,000 brain stem samples were collected from cervids of different species in 21 Member States and Norway. No TSE positive results were found. The opinion presents, analyses and discusses the results of the survey, explains the uncertainties involved and outlines the limitations of the survey and its results. It is concluded that the lack of one positive TSE test in the farmed and wild red deer and wild white-tailed deer which were sampled indicates that there is not a cervid TSE epidemic in the EU. It is also concluded that, considering the spreading of CWD within and from clusters in North America, the limitations of the sampling performed in the EU CWD/TSEs survey and the known susceptibility of certain cervid species to CWD, occurrence of cases of TSEs, especially in remote and presently unsampled geographic areas, may not be excluded in cervids in the EU. A few recommendations for further experimental studies and possible future monitoring of CWD/TSEs in EU cervids are also provided
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| 10. |
- Vågsholm, Ivar
(författare)
-
Statement on technical assistance related to the EFSA opinion on transformation of Animal By-Products into biogas and compost
- 2009
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Ingår i: EFSA Journal. - : Wiley. - 1831-4732. ; 7
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Tidskriftsartikel (refereegranskat)abstract
- EFSA’s Scientific Panel on Biological Hazards (BIOHAZ) was asked by the European Commission to clarify i) whether additional testing for Clostridium perfringens of the end product obtained from biogas and compost transformation of Animal By-Products (ABPs) would respond to the concerns expressed in the EFSA 2005 opinion on "the safety vis-à-vis biological risks of biogas and compost treatment standards of animal by-products" and, should this was not be the case, ii) to indicate if additional testing, according to the model of method 7 of the ABP Regulation, for another pathogen than Clostridium perfringens would respond to the recommendations laid down in the abovementioned opinion. Considering that digestion residues and compost are intended to be applied on land, that land naturally contains bacterial spores and that Clostridium perfringens is ubiquitous, the BIOHAZ Panel concluded that the absence of Clostridium perfringens is not necessary. The BIOHAZ Panel also concluded that end product testing does not respond to the recommendations given in the previous EFSA opinion, which concerns the validation of the efficacy of a process
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