ASTM D8220-20
(Guide)Standard Guide for Conducting Recall/Removal Procedures for Products in the Cannabis Industry
Standard Guide for Conducting Recall/Removal Procedures for Products in the Cannabis Industry
SIGNIFICANCE AND USE
4.1 In this guide, steps are suggested for the effective development, control, and management of procedures and records required for an effective product recall/removal from the marketplace.
4.2 This guide presents a systematic approach to procedures and documentation regarding the steps necessary to be taken in the event of a product recall or removal from the marketplace because of health, safety, or quality nonconformances.
4.3 This guide provides a procedural basis for conducting a mock recall for purposes of evaluating the efficacy of an organization’s existing traceability systems.
SCOPE
1.1 This guide describes the general best-practices action plan for conducting product recall and removal/withdrawal as related to any incident requiring the recovery of cannabis-derived products. This guide applies to all cannabis-derived products commercially manufactured and distributed for consumer use. This guide is for suppliers, consumers, retailers, and distributors. A specific product recall decision is the result of unacceptable product safety and requires notification of the appropriate governmental agencies governing the entity’s product safety laws. Governing regulatory agencies expect a product to be recalled if it is deemed to be unsafe, misbranded, or adulterated. These governing agencies are referenced as regulatory agencies throughout this guide. Various jurisdictional regulatory agencies may have specific and additional recall requirements falling beyond the recommendations of this guide. In these cases, the requirements of the governing regulatory agency must be followed. This document also provides general guidelines for the removal/withdrawal of products from the marketplace. Product removal/withdrawal is undertaken for purely commercial reasons that are typically unrelated to product safety and does not require regulatory agency notification. Product removal/withdrawal is carried out in the same manner as a product recall. This guide is being published as a best-practices approach and does not replace absolute jurisdictional regulatory requirements.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D8220 − 20
Standard Guide for
Conducting Recall/Removal Procedures for Products in the
1
Cannabis Industry
This standard is issued under the fixed designation D8220; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This guide describes the general best-practices action
mendations issued by the World Trade Organization Technical
plan for conducting product recall and removal/withdrawal as
Barriers to Trade (TBT) Committee.
related to any incident requiring the recovery of cannabis-
derived products. This guide applies to all cannabis-derived
2. Referenced Documents
products commercially manufactured and distributed for con-
2
2.1 ASTM Standards:
sumeruse.Thisguideisforsuppliers,consumers,retailers,and
D8270 Terminology Relating to Cannabis
distributors. A specific product recall decision is the result of
unacceptable product safety and requires notification of the
3. Terminology
appropriategovernmentalagenciesgoverningtheentity’sprod-
uct safety laws. Governing regulatory agencies expect a 3.1 For definitions of terms see Terminology D8270.
product to be recalled if it is deemed to be unsafe, misbranded,
3.2 Definitions of Terms Specific to This Standard:
or adulterated. These governing agencies are referenced as
3.2.1 adulteration, n—that cannabis or a cannabis-derived
regulatory agencies throughout this guide. Various jurisdic-
product: (1) consists in whole or in part of any contaminant, or
tional regulatory agencies may have specific and additional
decomposed substance; (2) contains any poisonous or delete-
recallrequirementsfallingbeyondtherecommendationsofthis
rious substance which may render it injurious to health; (3) has
guide. In these cases, the requirements of the governing
been manufactured, packaged, labeled, or held under unsani-
regulatory agency must be followed. This document also
tary conditions whereby it may have become contaminated, or
provides general guidelines for the removal/withdrawal of
whereby it may have been rendered injurious to health; (4) has
products from the marketplace. Product removal/withdrawal is
been manufactured, packaged or labeled using methods or
undertaken for purely commercial reasons that are typically
controls that do not conform to product safety requirements as
unrelated to product safety and does not require regulatory
defined by established specifications and/or procedures; (5)
agency notification. Product removal/withdrawal is carried out
fails to meet appropriate safety requirements; (6) is present in
in the same manner as a product recall. This guide is being
a container composed, in whole or in part, of any deleterious
published as a best-practices approach and does not replace
substance which may render the contents injurious to health.
absolute jurisdictional regulatory requirements.
3.2.2 cannabis-derived, n—any product containing any part
1.2 The values stated in SI units are to be regarded as
of the cannabis plant or any components extracted/derived
standard. No other units of measurement are included in this
from same.
standard.
3.2.3 consignee, n—anyonewhohasreceived,purchased,or
1.3 This standard does not purport to address all of the
used the product being recalled.
safety concerns, if any, associated with its use. It is the
3.2.4 correction, n—immediate action to eliminate a de-
responsibility of the user of this standard to establish appro-
tected nonconformity.
priate safety, health, and environmental practices and deter-
3.2.5 corrective and preventive action, (CAPA),
mine the applicability of regulatory limitations prior to use.
n—systematicapproachthatincludesactionsneededtocorrect,
1.4 This international standard was developed in accor-
avoid occurrence, and eliminate the cause of potential noncon-
dance with internationally recognized principles on standard-
forming product and other quality problems.
1
This guide is under the jurisdiction ofASTM Committee D37 on Cannabis and
2
is the direct responsibility of Subcommittee D37.02 on Quality Management For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Systems. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved April 15, 2020. Published May 2020. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summ
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