ASTM_E_1429_-_91_2000.pdf

Designation:E 1429 91(Reapproved 2000)Standard Guide forAssessing the Health Hazard of Pesticides to Applicatorsand Others with Potential Exposure1This standard is issued under the fixed designation E 1429;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(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide covers a stepwise process for using informa-tion concerning biological,chemical,physical,and toxicologi-cal properties of a pesticide or other chemical(s),or of aformulation to identify adverse effects that may occur topesticide applicators or others with potential exposure.1.2 The health hazard assessment process is complex andrequires decisions at a number of points;thus,the validity ofthe assessment depends on the soundness of those decisions,aswell as the soundness of the information used.All decisionsshould be based on carefully documented analyses so that anappropriate assessment can be completed,at the least cost,which is consistent with scientific validity.1.3 This guide assumes that the reader is knowledgeable inanimal toxicology and related pertinent areas,and reliesheavily on the judgment of the evaluator,particularly in thearea of chronic hazards.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:E 609 Terminology Relating to Pesticides2E 943 Terminology Relating to Biological Effects and En-vironmental Fate22.2OSHA Standard:29 CFR 1910.1200 Hazard Communication Standard33.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 health hazard assessmentthe identification andevaluation of the adverse effects likely to result from specifiedrelease(s)of a material.The estimate is only semi-quantitative.3.1.2 hazard identificationthe process of determiningwhether exposure to an agent can cause an increase in theincidence of a particular adverse health effect and whether theadverse health effect is likely to occur in humans.3.1.3 human exposure concentration(HEC)the concen-tration in the human environment based on application rate ordistribution,persistence in the environment,the chemical formof the material,and location of the pesticide or formulation inthe air,on surfaces,in vegetation,or in soil.3.1.4 maximum safe concentration for humans(MSCH)aprediction of the highest concentration of a material that wouldhave no unacceptable adverse effect on humans based ontoxicity testing in animals,clinical studies,and field experi-ence.4.Summary of Guide4.1 This guide describes a stepwise process for assessing therisk of a pesticide,chemical,or formulation to applicators andother individuals susceptible to exposure of pesticides byconsidering the relationship between the materials measuredor estimated human exposure concentration(s)and the adverseeffects likely to result.Unavailable necessary informationconcerning human exposure concentrations and adverse effectsis obtained through a stepwise program that starts withinexpensive information and progresses to expensive informa-tion if necessary.At the end of each iteration,the estimated ormeasured human exposure concentration(s)is compared withinformation on possible adverse effects to determine theadequacy of the available data for assessing the health hazard.If it is not possible to conclude that the health hazard is eitherminimal or potentially excessive,the available data are judgedinadequate to characterize the health hazard.If desired,appro-priate additional information is identified and obtained,so thatthe health hazard can be reassessed.The process is repeateduntil the health hazard is characterized adequately.5.Significance and Use5.1 Concern over the toxic effects observed in tests onanimals has demonstrated the need to assess hazards of manynew,and some presently used,materials.The process describedherein will help producers,regulatory agencies,and others tocompare alternative materials efficiently and adequately,com-pletely assess a final candidate material,or reassess the healthhazard of a material already in use.The process is not intendedfor pesticide registration;this guide provides techniques forhealth hazard assessment.1This guide is under the jurisdiction ofASTM Committee E35 on Pesticides andis the direct responsibility of Subcommittee E35.26 on Safety to Man.Current edition approved July 15,1991.Published September 1991.2Annual Book of ASTM Standards,Vol 11.05.3Available from Superintendent of Documents,U.S.Government PrintingOffice,Washington,DC 20402.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.5.2 Sequential