ASTM_D_8220_-_20.pdf

Designation:D822020Standard Guide forConducting Recall/Removal Procedures for Products in theCannabis Industry1This standard is issued under the fixed designation D8220;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 describes the general best-practices actionplan for conducting product recall and removal/withdrawal asrelated to any incident requiring the recovery of cannabis-derived products.This guide applies to all cannabis-derivedproducts commercially manufactured and distributed for con-sumer use.This guide is for suppliers,consumers,retailers,anddistributors.A specific product recall decision is the result ofunacceptable product safety and requires notification of theappropriate governmental agencies governing the entitys prod-uct safety laws.Governing regulatory agencies expect aproduct to be recalled if it is deemed to be unsafe,misbranded,or adulterated.These governing agencies are referenced asregulatory agencies throughout this guide.Various jurisdic-tional regulatory agencies may have specific and additionalrecall requirements falling beyond the recommendations of thisguide.In these cases,the requirements of the governingregulatory agency must be followed.This document alsoprovides general guidelines for the removal/withdrawal ofproducts from the marketplace.Product removal/withdrawal isundertaken for purely commercial reasons that are typicallyunrelated to product safety and does not require regulatoryagency notification.Product removal/withdrawal is carried outin the same manner as a product recall.This guide is beingpublished as a best-practices approach and does not replaceabsolute jurisdictional regulatory requirements.1.2 The values stated in SI units are to be regarded asstandard.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:2D8270 Terminology Relating to Cannabis3.Terminology3.1 For definitions of terms see Terminology D8270.3.2 Definitions of Terms Specific to This Standard:3.2.1adulteration,nthat cannabis or a cannabis-derivedproduct:(1)consists in whole or in part of any contaminant,ordecomposed substance;(2)contains any poisonous or delete-rious substance which may render it injurious to health;(3)hasbeen manufactured,packaged,labeled,or held under unsani-tary conditions whereby it may have become contaminated,orwhereby it may have been rendered injurious to health;(4)hasbeen manufactured,packaged or labeled using methods orcontrols that do not conform to product safety requirements asdefined by established specifications and/or procedures;(5)fails to meet appropriate safety requirements;(6)is present ina container composed,in whole or in part,of any deleterioussubstance which may render the contents injurious to health.3.2.2 cannabis-derived,nany product containing any partof the cannabis plant or any components extracted/derivedfrom same.3.2.3 consignee,nanyone who has received,purchased,orused the product being recalled.3.2.4 correction,nimmediate action to eliminate a de-tected nonconformity.3.2.5 correctiveandpreventiveaction,(CAPA),nsystematic approach that includes actions needed to correct,avoid occurrence,and eliminate the cause of potential noncon-forming product and other quality problems.1This guide is under the jurisdiction of ASTM Committee D37 on Cannabis andis the direct responsibility of Subcommittee D37.02 on Quality ManagementSystems.Current edition approved April 15,2020.Published May 2020.DOI:10.1520/D8220-20.2For 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.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)C