stroy bacteria in a similar fashion. The World Health Organization considers bothpenicillins and tetracyclines to be Critically Important in human medicine, unlike theFDA, which considers them only Highly Important. Another drug class, fluoroquinolones,considered Critically Important by FDA, was successfully banned for extralabeluse in food animals and any use was banned in poultry over concerns ofantibiotic resistance.Antibiotic resistance impacts public health when people consume food contaminatedwith antimicrobial-resistant bacteria resulting from the exposure of food animalsto antimicrobials, including cephalosporins. Gram-negative bacteria acquire or haveinnate resistance to cephalosporin through b-lactamases, which inactivate the drug itself.8 CMY-2, a type of AmpC enzyme, and the extended-spectrum b-lactamases(ESBLs) are found on the chromosomes ofmost Enterobacteriaceae and on plasmids inSalmonella, Escherichia coli and other Enterobacteriaceae.CMY-2 and ESBLs provideresistance to first-, second- and third-generationcephalosporins. CMY-2 is the b-lactamasemost associated with Salmonellafrom isolates that display resistance to ceftiofurand increasing resistance to ceftriaxone.9–11 ESBLs present in bacteria ofhuman concern include CTX-M, which isplasmid-mediated and has the potential toprovide resistance to all cephalosporins.Although now dominant only in Europeancountries, CTX-M enzymes are gaining afoothold in the United States but do notyet predominate. 12, 13 When mobilized,CTX-M enzymes often can be found onlarge multidrug-resistant plasmids. FDA isconcerned that cephalosporin resistancemay escalate as CTX-M becomes more“...FDA has consistentlybelieved, for severaldecades now, that thereare human health risks inusing subtherapeuticdoses of medicallyimportant antibiotics inanimal agriculture.”widespread. Severe bacterial infections resistant to cephalosporins, without FDA’s continuedaction, may face treatment failures from ineffective antibacterial regimens, increasingthe likelihood of death.Of particular concern is the evidence of cross-resistance among drugs in the broadcephalosporin class and the increase in reports of CMY-2 and CTX-M b-lactamases,which transfer cephalosporin resistance between enteric bacteria. 9 The surveillance effortsof both the NARMS as well as the Canadian Integrated Program for AntimicrobialResistance Surveillance have noted both in animal and human isolates theacquired resistance to b-lactams. Resistance to ceftiofur corresponds with resistance toceftriaxone, conferred by CMY-2, and provides resistance to first-, second- and thirdgenerationcephalosporins. Resistance to ceftiofur compromises the efficacy of ceftriaxone,a first-line therapy for treating human salmonellosis. CMY-2, in addition toproviding ceftiofur and ceftriaxone resistance, conveys resistance to many other b-lactams,including ampicillin and amoxicillin. 14 The concern over the pervasiveness andrange of CMY-2 in the ceftiofur and ceftriaxone surveillance data helps provide thebasis for FDA’s action as it supports the findings that cephalosporin use in food animalsis contributing to an upsurge in cephalosporin-resistant pathogens. 15The recent issuance is not an all-out prohibition of cephalosporin use in food animals.Many have complained that it is watered down compared with what was putforth in 2008, while some former critics now indicate that it is more reasonable.Prohibition in the 21st CenturyAs stated in the prohibition issuance, and in many agency documents in regard tothe use of antimicrobial drugs in animals, “When considering the foodborne pathway,the potential for human exposure to antimicrobial-resistantpathogens is significantlyless for food derived from minorspecies than it is for food derived fromthe food-producing major species. Theexposure potential is less in part becausethe amount of food derived from cattle,swine and poultry is much greater thanthe amount of food derived from sheep,goats and aquaculture, the minor speciesfrom which the most food is derived.”Minor species are defined as animalsother than cattle, swine, chickens,turkeys, horses, dogs, cats and humans.At this time, FDA is not planning toprohibit extralabel use of cephalosporinsin food-producing minor species becausethey do not believe that this use representsa significant risk to the publichealth, since these species are consumedless frequently. 16 Also, becausecephalosporins are approved for use insheep and goats, there is less potentialfor extralabel use in these species, accordingto the agency. Although peoplemay consume these animal species lessoften, any practice that selects for resistancegenes is concerning.The ban is slated to officially take effecton April 5, <strong>2012</strong>. Under Title 21 ofthe Code of Federal Regulations, parts530.21 and 530.25, the FDA order ofprohibition applies to certain extralabeluses of the cephalosporin class of antibioticsin food animals. This is a result offindings that such uses are likely to causean adverse event. The order of prohibitionstates that excluding cephapirin,cephalosporins are prohibited from extralabeluse in cattle, swine, chickens andturkeys for disease prevention purposes.Cephapirin is one of two cephalosporindrugs approved for use in food animals.Prohibition in the major species of foodanimals prevents using cephalosporins atunapproved doses. The ban prohibitsusing cephalosporins at unapproved frequenciesand durations, and for unapprovedroutes of administration. Alsoprohibited is use of cephalosporins whenthe drug is not approved for a particularspecies and production class. Said anotherway, since ceftiofur is the onlyother cephalosporin drug approved foruse in food animals, extralabel use ofceftiofur is permitted in food-producing42 F O O D S A F E T Y M A G A Z I N E
major species to treat or control an extralabeldisease indication, but onlywhen it is approved for and labeled foruse in that particular species and productionclass. Prophylactic use of ceftiofur istherefore not permitted in major speciesof food animals. Additionally, ceftiofuris to be administered only at dose levels,frequencies, durations and routes of administrationthat are clearly stated on approvedlabeling for that particularspecies and production class. Othercephalosporin drugs, apart from ceftiofurand cephapirin, are prohibited for alluses in the major species of food animals.It is hoped that the ban will have apositive public health impact and helpend the use of cephalosporins that areproven to cause resistant infections inpeople.In the Midst of OutbreaksThe warnings and calls for actionhave been coming for years. From theSwann Report issued in 1969 to themore recent media coverage and public meetings, food safety concerns over antibioticresistance are increasing. We are beyond the hypothetical “if” people contract antibiotic-resistantfoodborne infections. As recent outbreaks prove, we are in a crisis.Outbreaks of antibiotic-resistant infections occurring from food products in 2011brought the concern again to the forefront of consumers’, and food companies’,awareness as regulators modified their recall notices to alert the public to the dangersof antibiotic resistance in meat and poultry products.Notable recalls of 2011 include the following:• December’s “Northeastern Grocery Chain Recalls Ground Beef Products Due toPossible Salmonella Contamination,” in which we learn that the outbreak strain ofSalmonella Typhimurium initially tested resistant to multiple commonly prescribedantibiotics, including drug classes such as b-lactams, aminoglycosides andcephalosporins. The U.S. Department of Agriculture (USDA) <strong>Food</strong> <strong>Safety</strong> and InspectionService (FSIS) along with Centers for Disease Control and Prevention(CDC) also noted that the strain’s resistance can “increase the risk of hospitalizationor possible treatment failure in infected individuals.” 17• September’s “Arkansas Firm Recalls Ground Turkey Products Due to Possible SalmonellaContamination,” which noted in an update on the 27th that the sample ofground turkey referenced in the September 11 recall was confirmed as the SalmonellaHeidelberg outbreak strain (XbaI PFGE pattern 58/BlnI pattern 76) and FSIShad lab results that indicated the isolate is resistant to ampicillin, gentamicin, streptomycinand tetracycline. FSIS noted that “this antibiotic resistance may be associatedwith an increased risk of hospitalization or possible treatment failure ininfected individuals.” 18• The August 3 recall “Arkansas Firm Recalls Ground Turkey Products Due to PossibleSalmonella Contamination,” which stated that 36 million pounds of groundEngineeredMetal DetectionYou have a lot on your mind when it comesto plant floor safety. A compromised qualitycontrol program can cause costly downtime andjeopardize worker safety - adding up to big fines. Detectable: compound is molded into plastic fordetection by metal and X-ray inspection machinesDurable: substrate-imbedded solid injection moldedgraphics last longer than standard materialsProven: 4,000 hrs. of exhaustive field testing; QUVaccelerated weathering and liquid penetrant inspectionCustomized: flexible graphic capabilities optimizevisual management and compliance programsCompliant: engineered to comply with your foodsafety programsFind out why leading food processors are switchingto Lomont’s new signage options. Contact Carl,carlf@lomont.com or call 800.776.0380, ext. 1589.LomontI M TIN-MOLD TECHNOLOGIESA PRODUCT OF LOMONT MOLDING, INC.www.lomontimt.com F E B R U A R Y n M A R C H 2 0 1 2 43
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