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Microsoft word - deliverable.1.4.4
Advancing Beef Safety and Quality through Research and Innovation
Risk assessment of the chemical
safety of beef
Due date of deliverable: (M 48)Actual submission date: (M 48)
Project coordinator name: Geraldine Duffy
Coordinating Body: Teagasc, Ashtown Food Research Centre
Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006)
Restricted to other programme participants (including the Commission Services)
Restricted to a group specified by the consortium (including the Commission Services)
Confidential, only for members of the consortium (including the Commission Services)
ONE FORM TO BE COMPLETED FOR EACH DELIVERABLE BY THE PARTNER(S) RESPONSIBLE
FOR THE DELIVERABLE.
ALL SECTIONS OF THE REPORT MUST BE COMPLETED.
PLEASE RETURN TO PILLAR LEADER TO BE FORWARDED TO PROJECT MANAGER ROBERT
Partner Name(s) and ProSafeBeef Number:
Deliverable Number: 1.4.4
Risk assessment of the chemical safety of beefDate (please indicate what report type this is):
PLEASE GIVE FULL EVIDENCE BASED DESCRIPTION OF THE DELIVERABLE
(MAXIMUM 8 PAGES, BUT MAYBE MUCH LESS)
Results from the survey of EU beef have been submitted to RIVM for an exposure and risk assessment.
Survey of EU Beef
Retail beef sampling
The purchase of retail beef samples was coordinated by the European consumers grouping Conseur via its Spanishmember L'Organizacion de Consumidores y Usuarios (OCU). Consumer associations in France (UFC-Que Choisir),Spain (OCU), Slovenia (Zveza Potrosnikiv Slovenije), Italy (Altro Consumo), Belgium (Test-Aschats) and Portugal(Deco), and Teagasc laboratory staff in Ireland, purchased retail beef following a protocol provided by Conseur.
This selection of countries reflected the range of intensive (predominantly high density housed and grain/soya fedcattle) and extensive (predominantly low density pasture grazed cattle) domestic beef production systems employedacross Europe. These seven countries accounted for 52% of the total EU beef production in 2009 (Table 1;European Commission 2009a). Buying was carried out initially over the period October 2008 to March 2009 (Year1) with the tentative aim of identifying a high risk period when residues may be elevated as a result of the seasonaltreatment of cattle. Buying in Year 2 was subsequently carried out between October 2009 and January 2010 with theexception of Ireland (July 2010). Samples from Belgium and Portugal were purchased exclusively in Year 2. Beefwas purchased from a variety of public retail outlets including supermarkets, independent butchers, chains ofbutchers shops and public markets. Sampling was spread around at least three cities and the surrounding rural areasin each country and broadly reflected the market share of each type of outlet. Each beef sample consisted of a
1 Interim report are required for submission on an annual basis for ALL Running Deliverables. Theymay be shorter than the deliverable and describe the work completed towards the finalisation for thedeliverable during the twelve month. .
minimum 100 g portion of longissimus dorsi muscle, that is, the premium meat running along the spinal column(variously termed the entrecôte, beef chop, filet steak or sirloin) with any bone removed. Samples were sub-dividedinto two equal portions (A and B samples) which were stored in separately labeled plastic bags provided by Conseur.
Samples were frozen at −18°C for at least 24 h prior to transport. All samples were labeled by country, sample number and A or B designation. Information about sample purchases (retail outlets, purchase dates, identifyinginformation) was recorded by the consumers organisations on questionnaires which were retained by Conseur andnot provided to the analytical laboratories. Frozen samples were sent by overnight courier service to Ashtown FoodResearch Centre (Teagasc) in Dublin and the A samples were divided between the two analytical laboratories -Teagasc and Queen’s University Belfast (QUB). As a safeguard against transportation or storage failure oranalytical dispute, the B samples were stored at −18°C in separate locations from the A samples, either at the alternative analytical laboratory or retained by the purchasing consumers organisation.
Participating countries and summary results of anthelmintic drug residue survey of European
Beef production 2009
(1000 tonnes cattle
(kg per capita) b
4004 (EU27 total 7696)
a European Commission 2009a; b European Commission n.d.b.; c 2004 data; d 2008 data
Incidence of drug residues
During Year 1 of the European beef survey (October 2008 to March 2009) no clear high risk period was identifiedduring which the rate of positive samples was elevated. Sampling in Year 2 was subsequently carried out betweenOctober 2009 and January 2010 with the exception of Ireland (July 2010). Of the 1061 beef samples analysed, 26contained detectable residues of anthelmintic drugs (Table 3) at concentrations ranging from 0.2 to 171 µg kg-1(Table 2). This 2.45 % positive rate can be considered reassuringly low given that the group of drugs in question arelegal, widely and routinely used in the beef industry and serve a valuable purpose in maintaining cattle health. Theevidence of this survey suggests popular usage of levamisole (France, Spain, Belgium) and the avermectins(eprinomectin and doramectin in France, moxidectin in Italy, doramectin in Belgium, ivermectin in Ireland). Therewere also isolated cases of albendazole and rafoxanide residues in Slovenia and Italy respectively and, most notably,a high incidence of closantel residues in Ireland.
Incidence of non-compliance with MRLs
Of the 1061 beef samples analysed, none were non-compliant with respect to current EU MRLs or action levels.
One sample, purchased in Ireland, contained ivermectin at a concentration of 3.4 µg kg-1 (Table 2), comfortablybelow the 20 µg kg-1 EU action level in muscle. A recent ProSafeBeef project study applied the recommended doseof ivermectin to a beef cow and, after a withdrawal period of only two days, detected 487 µg kg-1 ivermectin in liverand 14 µg kg-1 in muscle (Cooper et al. 2011). The recommended withdrawal period for this product was 42 days.
One other survey sample, purchased in Italy, was close to non-compliance with a MRL. Rafoxanide was detected at28.6 µg kg-1 in muscle for which the MRL is 30 µg kg-1. Rafoxanide for the treatment of ruminants is marketed in
Italy by Intervet Productions Srl under the brand name Ranigel®. All other residues detected in this survey werecomfortably below their MRLs in muscle.
Details of positive samples in European retail beef survey for anthelmintic drug residues
a 2010 EC Action Level; b Comprised of 0.91 µg kg-1 albendazole sulphone + 1.37 µg kg-1 albendazoleamino sulphone; c CCα for albendazole sulphone/albendazole amino sulphone
Positive rates by country
With the exception of Portugal, from which only 40 samples were tested, residues were detected in at least onesample from every country, with 0.6 to 7.0% of beef samples containing residues. Ireland exhibited the highestincidence of anthelmintic drug residues in locally purchased beef (7.0 %; Table 3). Given that the majority of beefsold in Irish shops is locally produced, this higher incidence of residues is likely to be related to the temperate andwet weather conditions and extensive cattle production systems prevalent in Ireland (low stocking density, highgrass intake) which are conducive to the spread of helminth parasites, requiring the routine use of large quantities ofanthelmintic medications (Bennema et al. 2010). In a questionnaire survey of 1887 dairy cattle herds in Europe,Bennema and co-workers found that preventive treatment of cattle against gastrointestinal nematodes wasundertaken on 1, 6, 17, 19 and 59% of herds in Sweden, Germany, UK, Belgium and Ireland, respectively. Thisremarkably high usage of preventive anthelmintic treatments in Ireland is symptomatic of the findings of Murphyand co-workers who studied helminth loads in culled cows in Ireland and concluded that “given the prevalence ofparasitic gastrointestinal and respiratory nematodes shown in this study and given the fact that fasciolosis appears tobe endemic in much of Ireland, it may be the norm for cattle to be simultaneously parasitized with a variety ofhelminths” (Murphy et al. 2006).
The detection in Irish beef samples of compliant closantel residues, along with a single compliant ivermectinfinding, may be indicative of the common usage of veterinary preparations such as Closamectin (containing 0.5%ivermectin and 12.5% or 20% closantel) which was developed locally by Norbrook Laboratories Limited andmarketed globally. Closantel is a salicylanilide derivative effective in cattle and sheep against both mature anddevelopmental stages of various trematodes, nematodes and arthropods. It is poorly metabolised in both ruminantspecies, being bound extensively to serum albumin, leading to a long elimination half-life from plasma and tissues of2-3 weeks (Michiels et al. 1987). After 28 d withdrawal from a 5 mg kg-1 bodyweight intra-muscular injection ofradiolabelled closantel, 940 µg kg-1 closantel was detected in bovine leg muscle (Michiels et al. 1987). After 56 dwithdrawal residues were still detectable at 390 µg kg-1. The EU MRL for closantel in muscle is 1000 µg kg-1.
Closamectin, in its injectable format, also has a recommended dosage rate of 5 mg kg-1 bodyweight and a bovinewithdrawal period of 35 d. It is, therefore, not surprising that closantel residues as high as 171 µg kg-1 were detectedin beef purchased in Ireland where such medications are routinely used (Table 2). Ivermectin is the most widelyused anthelmintic drug in Ireland, followed by closantel and the equally popular levamisole, nitroxynil, fenbendazoleand triclabendazole (M. Danaher, personal communication).
The National Residues Surveillance Scheme (NRSS) for Ireland is performed by Teagasc at Ashtown Food ResearchCentre, Dublin. Between 2000 and 2008, 5566 bovine samples of Irish origin were tested for residues ofbenzimidazole and avermectin (including ivermectin) anthelmintic drugs. Only two liver samples were non-compliant, testing positive for avermectin residues above the applicable MRLs (Teagasc n.d.), demonstrating thatIrish beef production does not suffer from the misuse of anthelmintic drugs.
It should also be noted that the Irish results are in keeping with long term residues surveillance data from GreatBritain (that is, the United Kingdom excluding Northern Ireland) where similar weather and extensive productionsystems apply. Since 2000, the Veterinary Medicines Directorate, which carries out the NRSS for Great Britain,testing cattle liver for residues of avermectins, benzimidazoles and levamisole, has reported non-compliant results ononly seven occasions (Veterinary Medicines Directorate n.d.). The compounds detected in liver were fenbendazole(0.8-14.3 mg kg-1), ivermectin (270 and 350 µg kg-1) and doramectin (130 µg kg-1). To date, closantel has not beenroutinely monitored in bovine samples under the NRSS in either Ireland or the UK. As a result of the ProSafeBeefproject, the capability to monitor closantel residues has been adopted by the laboratories responsible for NRSStesting in both Ireland and Northern Ireland.
It should be stressed that beef samples in the current study were classified by country of purchase, not by country oforigin. Determining the country of primary production of retail beef cannot be achieved reliably at the point ofpurchase and the primary purpose of this study was to assess the exposure of the consumer to residues in the beefthey buy rather than determine anthelmintic drug usage in specific countries. In some countries, such as Ireland,retail beef is derived largely from domestic production. This is in contrast to Italy, one of the larger European beefproducers and consumers (Table 1), which also imports significant quantities of beef from other countries,particularly France, as indicated by the retail survey purchasing questionnaires.
Survey of Brazilian Beef
The survey of Brazilian beef is ongoing. A total of 310 beef steaks have been analysed for anthelmintic drugresidues. The initial results of the survey indicate a high incidence of triclabendazole residues in Brazilian beef. Atotal of 68 out of 310 samples contained triclabendazole residues at >50 μg kg-1. In the next period work willcontinue on the analysis of beef samples, including determination of the compliance status of these samples.
Exposure and Risk Assessment
RIVM have performed a first risk assessment using the methodology used to set MRLs for veterinary drugs in
animal products. Using this approach the exposure to each drug assessed by using high levels of consumption of
these products in combination with the MRLs set and replaced the MRL set for beef by the concentration data
generated within the ProSafeBeef project (total mean, mean positive samples, highest level analysed). Since the
concentrations of all the drugs analysed were below the MRL, the sum of the exposure via all these foods did not
exceed the ADI in any of the drugs, showing that the measurements pose no risk for food safety.
RIVM will complete the Exposure and Risk Assessment of EU before the end of month 51. It is expected that thisstudy will show that anthelmintic residues are at a fraction of the ADI. This process will be repeated for each drugthat has been analysed in the survey. The output from this exposure assessment can be used to risk and prioritiseresidues, highlighting what the most important anthelmintic drug residues to monitor in beef.
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