ASTM_D_8250_-_19.pdf

Designation:D825019Standard Practice forApplying a Hazard Analysis Critical Control Points(HACCP)System for Cannabis Consumable Products1This standard is issued under the fixed designation D8250;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 addresses the principles to follow whenimplementing and managing a Hazard Analysis Critical Con-trol Point(HACCP)system for cannabis consumable products.This practice is not intended for cannabis industrial products(e.g.,hemp products).1.2 UnitsThe values stated in SI units are to be regardedas standard.No other units of measurement are included in thisstandard.1.3 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.1.4 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:2E2590 Guide for Conducting Hazard Analysis-Critical Con-trol Point(HACCP)Evaluations2.2 Other Documents:HACCP Principles and Applications Guidelines3General Principles of Food Hygiene43.Terminology3.1 Definitions:3.1.1 cannabis consumable productscannabis productsthat are directly consumed by people or animals either throughingestion or inhalation.3.1.2 Codex Alimentariuscollection of internationally rec-ognized standards,codes of practice,guidelines,and otherrecommendations relating to foods,food production,and foodsafety.3.1.3 controlmanagement of a condition to ensure that thecompliance to a criterion is being met.3.1.4 control pointstep in which a biological,chemical(including radiological),and physical hazard can be controlled.3.1.5 correctionimmediate action taken to correct a non-conformance.3.1.6 corrective actionaction taken to correct a non-conformance;it requires that the root cause is identified toensure that the non-conformance does not re-occur.3.1.7 critical control point(CCP)step at which controlcan be applied and is essential to prevent or eliminate a foodsafety hazard or reduce it to an acceptable level.3.1.8 critical limitmaximum and/or minimum value towhich a biological,chemical,or physical parameter shall becontrolled at a CCP to prevent,eliminate,or reduce to anacceptable level the occurrence of a food safety hazard.3.1.9 deviationfailure to meet a critical limit.3.1.10 hazard analysis critical control point(HACCP)asystematic approach to the identification,evaluation,andcontrol of hazards that may be present in cannabis consumableproducts.3.1.11 HACCP teama multidisciplinary group of peoplethat work at the site and are responsible for developing,implementing,and maintaining a HACCP system.3.1.12 hazardbiological,chemical(includingradiological),or physical agent that can cause harm to theconsumer when it is not controlled.3.1.13 hazard analysisthe process of collecting and evalu-ating information about the hazards associated with the canna-bis consumable product to determine its significance andwhether it needs to be addressed in the HACCP system.1This practice is under the jurisdiction of ASTM Committee D37 on Cannabisand is the direct responsibility of Subcommittee D37.02 on Quality ManagementSystems.Current edition approved March 1,2019.Published March 2019.DOI:10.1520/D8250-19.2For 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.3National Advisory Committee on Microbiological Criteria for Foods,August14,1997(www.fda.gov).4Codex Alimentarius,Food and Agriculture Organization(FAO)CA/RCP1-1969,Rev 4.2003.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 3.1.14 monitoringto conduct a series of pre-planned ob-servations and/or measurements to assess whether the CCP isunder control and to generate records that will be used forverification purposes.3.1.15 pre-requisite programs(PRP)procedures,includ-ing good manufacturing practices(GMPs),th