ASTM_D_8347_-_21a.pdf

Designation:D834721aStandard Guide forRequirements for Analytical Laboratory Related ProfessionsWithin the Cannabis and Hemp Industries1This standard is issued under the fixed designation D8347;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 guide can provide certification bodies,trainingproviders,employers,and certificate issuers,with best-practiceguidance for administering their respective programs for sup-porting analytical laboratory-related professions within thecannabis and hemp industries.1.2 This guide recommends requirements for experience,training,education,and the body of knowledge(BoK)neces-sary for analytical laboratory related professions within thecannabis and hemp industries listed in Table 1.1.3 This guide provides recommendations for articulatingprofessional requirements for training and education or earningcertificates.Its content does not supersede requirements fortraining or earning a certificate defined by jurisdictional entitiessuch as government or other regional regulatory bodies.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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2E2659 Practice for Certificate ProgramsE2708 Terminology for Accreditation and Certification2.2 Other Standards:21CFR 111 Dietary Supplements321CFR 117 FSMA and Food Safety321CFR 210 Pharmaceutical Packaging and Holding321CFR 211 Pharmaceuticals3ISO/IEC 17025:2017 General requirements for the compe-tence of testing and calibration laboratories43.Terminology3.1 Definitions:3.1.1 biosafety level 2,na biosafety level classificationpertaining to laboratories that work with agents associated withhuman diseases(that is,pathogenic or infections organisms)that pose a moderate health hazard.3.1.2 certificate,na document(letter,card,or other me-dium)awarded to certificate holders that designates the suc-cessful completion of a credentialing programs requisites.E2659,E27083.1.3 certification agency,nthe organizational or admin-istrative unit that offers or operates,or both,a certificationprogram.E2659,E27083.1.4 certificate program,na non-degree-granting educa-tion of training program consisting of(1)a learning event orseries of events designed to educate or train individuals toachieve specified learning outcomes within a defined scope,and(2)a system designed to ensure individuals receive acertificate only after verification of successful completion of allprogram requisites,including but not limited to an evaluationof learner attainment of intended learning outcomes.E2659,E27083.1.5 certification,nprocedure and action by a duly au-thorized body of determining,certifying,and attesting inwriting to the qualifications of individuals,processes,procedures,or items in accordance with application require-ments.1This guide is under the jurisdiction of ASTM Committee D37 on Cannabis andis the direct responsibility of Subcommittee D37.06 on Personnel Training,Assessment,Credentialing.Current edition approved Nov.1,2021.Published December 2021.Originallyapproved in 2021.Last edition approved in 2021 as D8347 21.DOI:10.1520/D8347-21A.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.3Available from U.S.Government Printing Office,Superintendent ofDocuments,732 N.Capitol St.,NW,Washington,DC 20401-0001,http:/www.access.gpo.gov.4Available from International Organization for Standardization(ISO),ISOCentral Secretariat,Chemin de Blandonnet 8,CP 401,1214 Vernier,Geneva,Switzerland,https:/www.iso.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1?3.1.5.1 personnel certification,nprocedure and action bya duly authorized body of determining,verifying,and attestingin writing to the qualif