ASTM_E_2169_-_12.pdf

Designation:E216912An American National StandardStandard Practice forSelecting Antimicrobial Pesticides for Use in Water-MiscibleMetalworking Fluids1This standard is issued under the fixed designation E2169;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 practice provides recommendations for selectingantimicrobial pesticides(microbicides)for use in water-miscible metalworking fluids(MWF).It presents informationregarding regulatory requirements,as well as technical factorsincluding target microbes,efficacy and chemical compatibility.1.2 This guide is not an encyclopedic compilation of all theconcepts and terminology uses by chemists,microbiologists,toxicologists,formulators,plant engineers and regulatory af-fairs specialists involved in antimicrobial pesticide selectionand application.Instead,it provides a general understanding ofthe selection process and its supporting considerations.1.3 The values in SI units are to be regarded as the standard.1.4 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.2.Referenced Documents2.1 ASTM Standards:2D1067 Test Methods for Acidity or Alkalinity of WaterD1293 Test Methods for pH of WaterD3519 Test Method for Foam in Aqueous Media(BlenderTest)D3946 Test Method for Evaluating the Bacteria Resistanceof Water-Dilutable Metalworking Fluids(Withdrawn2004)3D4478 Test Methods for Oxygen Uptake(Withdrawn 1994)3D5465 Practice for Determining Microbial Colony Countsfrom Waters Analyzed by Plating MethodsE686 Method for Evaluation of Antimicrobial Agents inAqueous Metal Working Fluids(Withdrawn 2004)3E1302 Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking FluidsE1326 Guide for Evaluating Nonconventional Microbiologi-cal Tests Used for Enumerating BacteriaE1497 Practice for Selection and Safe Use of Water-Miscible and Straight Oil Metal Removal FluidsE2144 Practice for Personal Sampling and Analysis of En-dotoxin in Metalworking Fluid Aerosols in WorkplaceAtmospheres2.2 Government Standards:29 CFR 1910 Occupational Safety and Health Standards440 CFR 152 Pesticide Registration and Classification Proce-dures440 CFR 158 Pesticide Programs Data Requirements forRegistration449CFR100-180 ResearchandSpecialProgramsAdministration,Department of Transportation4PR Notice 2000-1 Applicability of the Treated ArticlesExemption to Antimicrobial PesticidesDirective 98/8/EC of the European Parliament and of theCouncil of 16 February 1998 concerning the placing ofbiocidal products on the market3.Terminology3.1 active ingredient(a.i.),nthe chemical component orcomponents of an antimicrobial pesticide that provides itsmicrobicidal performance.3.2 activity spectrum,nvariety or range of microbesagainst which an antimicrobial pesticide is effective.3.3 antimicrobial pesticide,nchemical additive,regis-tered under 40 CFR 152,for use to inhibit growth,proliferationor both of microorganisms.3.3.1 DiscussionAntimicrobial pesticides are registeredfor one or more end-use applications,or sites,for use within anapproved dose range.1This practice is under the jurisdiction of ASTM Committee E34 on Occupa-tional Health and Safety and is the direct responsibility of Subcommittee E34.50 onHealth and Safety Standards for Metal Working Fluids.Current edition approved Nov.1,2012.Published November 2012.Originallyapproved in 2001.Last previous edition approved in 2007 as E2169-01(2007).DOI:10.1520/E2169-12.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.4Code of Federal regulations available form United States Government PrintingOffice,Washington,DC.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.4 bactericide,nantimicrobial pesticide specifically orprimarily effective against bacteria.3.5 biocide,nany chemical intended for use to kill orinhibit organisms.3.5.1 DiscussionBiocide is a term commonly used syn-onymously with the preferred antimicrobial pesticide or mi-crobicide.3.6 bioburden,nthe level of microbial contamination(biomass)in a system.3.6.1 DiscussionTypically bioburden is defined in termsof either biomass or numbers of cells per unit volume or massor surface area material tested(g biomass/mL sample;gbiomass/g sample;cell/mL sample,colony forming units(CFU)/mL,and so forth).3.7 biodete