ASTM_E_2946_-_13.pdf

Designation:E294613Standard Test Method forDetermining the Bacteria-Reducing Effectiveness of Food-Handler Handwash Formulations Using Hands of Adults1This standard is issued under the fixed designation E2946;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method is designed to determine the activity offood-handler handwashes against transient bacterial flora onthe hands.1.2 Performance of this procedure requires the knowledgeof regulations pertaining to the protection of human sub-jects(1)2.1.3 This test method should be performed by persons withtraining in microbiology,in facilities designed and equippedfor work with potentially infectious agents at biosafety level 2(2).1.4 UnitsThe values stated in SI units are to be regardedas standard.No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.For more specificprecautionary statements see 8.1.1.2.Referenced Documents2.1 ASTM Standards:3E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE1174 Test Method for Evaluation of the Effectiveness ofHealth Care Personnel Handwash FormulationsE2756 Terminology Relating to Antimicrobial and AntiviralAgents2.2 AATCC Standards:4Test Method 147 Antibacterial Activity Assessment of Tex-tile Materials:Parallel Streak Method3.Terminology3.1 DefinitionsSee Terminology E2756.3.2 food-handler handwash,na water or non-water-aidedformulation for use in food service settings intended to kill orremove transient bacteria,or both from the hands.3.3 test material,na product or formulation that incorpo-rates one or more antimicrobial ingredients.4.Summary of Test Method4.1 This test method is performed using adult subjects whohave provided written informed consent,and whose handshave been determined to be free of any apparent damage at thetime of participation in the study.Subjects are to refrain fromuse of any antimicrobials for at least one week prior to theinitiation of test procedures(Section 11).4.2Subjects contaminate hands with E.coli incorporatedinto a medium or heavy organic soil(beef broth or hamburger,respectively),which then is distributed over all surfaces of thehands and fingers to result in a minimum baseline recoverypopulation of 107colony forming units(CFU)/hand.4.3 Test material effectiveness is measured by comparingthe number of challenge bacteria recovered from contaminatedhands after a single application of the test material to thenumber recovered from contaminated hands not exposed to thetest material.5.Significance and Use5.1 Hand hygiene is considered one of the most importantmeasures for preventing the spread of infectious microorgan-isms and is critical for reducing the incidence of food-bornedisease.Food-handling settings are unique in that moderate toheavy soil load present on hands often can influence the abilityof a product to remove or kill microorganisms(3,4).Test1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct.1,2013.Published November 2013.DOI:10.1520/E2946132The boldface numbers in parentheses refer to a list of references at the end ofthis standard.3For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.4Available from American Association of Textile Chemists and Colorists(AATCC),P.O.Box 12215,Research Triangle Park,NC 27709,http:/www.aatcc.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 methods are needed for assessing the efficacy of hand hygieneproducts under conditions representative of those encounteredin a food-handling environment.5.2 This test method is specifically designed to evaluate theeffectiveness of food-handler products to kill and removebacteria from experimentally-contaminated hands under con-ditions of moderate to heavy organic soil load.The inclusion ofsoils typical of food service setting makes this a methodologymore appropriate than Test Method E1174,which was de-signed to evaluate healthcare personnel hand washes and doesnot include an option to include soil(4).6.Apparatus6.1 Colony CounterAny of several types may be used;forexample,Quebec colony counters and similar devices.Automated,computer