ASTM D8220-20

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

• Status: Published
• Publication Date: 14-Apr-2020
• ICS: 11.120.99 - Other standards related to pharmaceutics
• ICS: 65.020.20 - Plant growing
• Technical Committee: D37 - Cannabis
• Drafting Committee: D37.02 - Quality Management Systems

Relations

• Referred By: ASTM D8222-21a - Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use of Cannabis/Hemp Products
• Effective Date: 15-Apr-2020

Overview

ASTM D8220-20: Standard Guide for Conducting Recall/Removal Procedures for Products in the Cannabis Industry establishes best-practice guidelines for managing product recalls and withdrawals for cannabis-derived products. Developed by ASTM International, this standard provides a systematic approach for suppliers, consumers, retailers, and distributors to recover cannabis products from the market due to health, safety, or quality nonconformances. It also covers general procedures for product removal or withdrawal for commercial reasons, emphasizing compliance with jurisdictional regulatory requirements and promoting effective communication across the supply chain.

Key Topics

• Recall and Removal/Withdrawal Procedures
  Outlines steps to develop controlled, documented processes for both mandatory product recalls (due to safety or regulatory issues) and voluntary product removals (for non-safety related reasons).

• Roles and Responsibilities
  Defines clear responsibilities for senior management, recall coordinators, and other team members, ensuring accountability and coordination during a recall event.

• Risk Assessment and Communication
  Details best practices for performing risk-based health hazard evaluations, identifying product defects, and informing the appropriate regulatory agencies, stakeholders, and consumers.

• Documentation and Traceability
  Emphasizes maintaining comprehensive records, including lists of affected parties, communication archives, product disposition documentation, and periodic status reports to both internal stakeholders and regulatory bodies.

• Mock Recalls and QMS Integration
  Presents procedures for conducting mock recalls as a test of organizational readiness, supporting continuous improvement in the traceability and recall system as part of a robust quality management system (QMS).

Applications

ASTM D8220-20 is essential for any organization involved in the production, distribution, or sale of cannabis-derived products, including:

• Manufacturers and Processors: Ensuring compliance with regulatory mandates and maintaining consumer safety by having actionable recall plans.
• Distributors and Retailers: Responding rapidly to recall events with established processes for product isolation, communication, and documentation.
• Quality Assurance Teams: Implementing and auditing recall procedures, performing root cause analyses, and updating the organization’s QMS based on recall outcomes.
• Regulatory and Risk Managers: Aligning recall actions with jurisdictional requirements and protecting the organization from legal and reputational risk.
• Consumers and End-Users: Providing clear guidance on product recalls, returns, and withdrawals in a transparent and timely manner.

This standard is particularly valuable for organizations operating in diverse regulatory environments, as it distinguishes between regulatory-driven recalls and voluntary product withdrawals, providing flexibility and guidance according to the nature of the situation.

Related Standards

• ASTM D8270 - Terminology Relating to Cannabis: Provides essential definitions for terms used in D8220-20.
• ISO 9001 - Quality management systems: Establishes general requirements for QMS into which recall/removal procedures may be integrated.
• Jurisdiction-Specific Regulatory Guidelines: Local, state, or national legislation governing recall notifications, product safety, and consumer protection in the cannabis industry.

Practical Value

Implementing ASTM D8220-20 enables cannabis industry organizations to:

• Reduce legal and reputational risks by following proven recall/removal processes and meeting regulatory expectations.
• Improve product safety and quality control with documented procedures for identifying, isolating, and removing defective or hazardous products from the supply chain.
• Strengthen traceability and accountability through comprehensive records and regular mock recall exercises.
• Enhance consumer trust and demonstrate commitment to safety and regulatory compliance in a rapidly evolving market.

Keywords: Cannabis industry, product recall, product removal, recall procedures, quality management, traceability, regulatory compliance, ASTM D8220-20.

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
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-
2.1 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.
This guide is under the jurisdiction ofASTM Committee D37 on Cannabis and
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 [e-mail]. 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 Summary page on
D8220-20. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D8220 − 20
3.2.6 downstream traceability, n—describes the procedure 3.2.20 stock recovery, n—removalorcorrectionofaproduct
and tools implemented in order to locate an event that has that has not been marketed or has not left the direct control of
occurred after the transfer of property or after the physical the manufacturer.
transfer of products from the manufacturer to a third party.
3.2.21 upstream traceability, n—describes the procedures
and tools implemented in order to locate an event that has
3.2.7 effectiveness checks, n—series of direct visits, tele-
phonecalls,letters,ore-mailstoassurethatallaffectedpersons already occurred before the customer concerned has become
have been notified of the recall and have taken appropriate legally or physically responsible for the products.
action.
4. Significance and Use
3.2.8 hazard, n—potential source of harm.
4.1 In this guide, steps are suggested for the effective
3.2.9 health hazard evaluation, n—evaluation of a health
development, control, and management of procedures and
hazard presented by a defective product where the organization
records required for an effective product recall/removal from
has the responsibility to conduct the evaluation before devel-
the marketplace.
oping a recall strategy.
4.2 This guide presents a systematic approach to procedures
3.2.9.1 Discussion—In any recall, the jurisdictional regula-
and documentation regarding the steps necessary to be taken in
tory agency will conduct an independent evaluation.
the event of a product recall or removal from the marketplace
3.2.10 human error, n—departure from acceptable or desir-
because of health, safety, or quality nonconformances.
able practices on the part of an individual resulting in an
4.3 This guide provides a procedural basis for conducting a
unacceptable or undesirable result.
mock recall for purposes of evaluating the efficacy of an
3.2.11 immediate health risk, n—(1) a reasonable probabil-
organization’s existing traceability systems.
ity that use of, or exposure to the product will cause serious
5. Responsibilities
adverse health consequences or death; or (2) that use of, or
exposure to the product may cause temporary or medically
5.1 Senior Management:
reversible adverse health consequences, or an outcome where 5.1.1 For the purposes of a specific product recall or
there is a probability of serious adverse health consequences.
removal/withdrawal, the senior management team consists of,
but is not limited to, the following individuals: owners,
3.2.12 misbranded, n—a packaged product which has label-
operationsleaders,consumersalesleaders,distributionleaders,
ing that is false, inaccurate, misleading, or missing any
quality management, customer service managers, local facility
regulatory required information.
managers, technical experts, and legal counsel.
3.2.13 mock recall, n—routine exercises conducted by
5.1.2 Senior management is responsible for working with
manufacturers, processors, distributors, suppliers, and other
the recall coordinator(s) for the assessment of any potential
various trading partners in the supply chain to assess their
product recall or product removal/withdrawal situation by
recall procedures and responsiveness and traceability systems.
appropriately addressing the following:
3.2.14 quarantine, n—the status of materials isolated physi-
5.1.2.1 Ascertaining the legal implications of the potential
cally or by other effective means.
recall or removal/withdrawal decision, including likely expo-
sure to civil liability and damage to the organization’s image
3.2.15 recall, n—removal or correction of a marketed prod-
and integrity;
uctthatdoesnotmeetspecificationssetwithinthesupplychain
5.1.2.2 Determining the potential level of government and
or does not meet local governmental requirements.
media scrutiny;
3.2.15.1 Discussion—The recall is typically constrained to
5.1.2.3 Determining the extent, if any, to which regulatory
product safety issues. A product recall may include a market
agencies need to be involved; and
removal/withdrawal, or a stock recovery, if a potential health
5.1.2.4 Determining and mitigating potential interferences
hazard has been identified.
with normal business activity.
3.2.16 recall strategy, n—course of action followed in
5.2 Recall Coordinator(s):
conducting a recall that addresses the depth of the recall, need
5.2.1 The recall coordinator(s) are appropriately designated
for public warnings, and extent of effectiveness checks for the
by senior management and are trained, experienced personnel
recall.
who are responsible for managing complaint and quality defect
3.2.17 recalling organization, n—organization initiating the
investigations.
recall and who has the primary responsibility for the
5.2.2 Recall coordinator(s) are responsible for working with
manufacture, marketing, and/or distribution of the product in
senior management to decide the measures to be taken to
question.
manage risk(s) presented by recalls and removal/withdrawals.
3.2.18 removal/withdrawal, n—removal or correction of
5.2.3 These persons are representatives of the quality assur-
products from the marketplace for reasons that may be related
ance organization, unless otherwise justified.
to product quality and not in violation of governmental
5.2.4 The recall coordinator(s) should be responsible for
requirements.
communicating timely and accurate information to the depart-
3.2.19 root cause analysis, (RCA), n—analysis necessary to ments responsible for legal, financial, technical, regulatory,
determine the original or true cause of a system, product, or public relations, insurance, other relevant departments and
process nonconformity. senior management.
D8220 − 20
5.2.5 The recall coordinator(s) are responsible for maintain- 6.6 Classify the degree to which the product’s defect is
ing up-to-date communication and contact lists for the organi- obvious to the consumer or other user:
zation’s recall team members
6.6.1 Know the degree to which the product remains unused
5.2.6 If recall or removal/withdrawal is considered, it is the in the marketplace;
responsibility of the recall coordinator(s) to work with senior
6.6.2 Which jurisdictional agency should be notified, and;
management to perform a recall risk assessment. Once this
6.6.3 What information is relevant to the jurisdictional
assessment has been completed and the determination is made
agency, which usually includes:
that:
6.6.4 Identity of the product involved;
5.2.6.1 The product is not completely within company
6.6.5 The reason for the recall, including dates and circum-
control and the product poses an actionable health risk, or;
stances under which the problem was discovered, and;
5.2.6.2 The product is not completely within company
6.
...