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ASTM D8423-22

(Specification)

Standard Specification for Environmental Conditions for Post-packaged Storage and Retail Merchandising of Cannabis/Hemp Flower

Standard Specification for Environmental Conditions for Post-packaged Storage and Retail Merchandising of Cannabis/Hemp Flower

SCOPE
1.1 This standard specifies the environmental conditions, such as temperature, humidity, and lighting under which cannabis/hemp flowers in fresh format intended for human use are packaged to be stored to ensure the safety, quality, and weight stabilization of the packaged flower.  
1.1.1 This specification does not apply to frozen cannabis/hemp.  
1.1.2 This specification does not apply to cannabis/hemp intended for extraction.  
1.2 This specification applies to controlling the environment surrounding packaged cannabis/hemp flower.  
1.3 This specification is to be followed by licensed operators in the cannabis/hemp space who move the packaged crop(s) through the distribution supply chain to another licensed operator or to the end user.  
1.4 Purveyors of cannabis/hemp flower include, but are not necessarily limited to: the packager, transportation companies, warehousing operations, and retail operations.  
1.5 Security of the packaged cannabis/hemp flower while in storage is not within the scope of this specification.  
1.6 This specification is intended to remain valid until ownership of the packaged cannabis/hemp flower is transferred to another licensed operator or to the final consumer.  
1.7 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.  
1.8 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-Jun-2022
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
D37 - Cannabis
Drafting Committee
D37.04 - Processing and Handling
Current Stage
Ref Project

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ASTM D8423-22 - Standard Specification for Environmental Conditions for Post-packaged Storage and Retail Merchandising of Cannabis/Hemp FlowerASTM D8423-22 - Standard Specification for Environmental Conditions for Post-packaged Storage and Retail Merchandising of Cannabis/Hemp Flower
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ASTM D8423-22 - Standard Specification for Environmental Conditions for Post-packaged Storage and Retail Merchandising of Cannabis/Hemp Flower
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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:D8423 −22
Standard Specification for
Environmental Conditions for Post-packaged Storage and
1
Retail Merchandising of Cannabis/Hemp Flower
This standard is issued under the fixed designation D8423; 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.
INTRODUCTION
The cannabis/hemp industry, from seed to consumption, is undergoing a transition and moderniza-
tion. Thus, standards for ensuring safety, quality, and weight stabilization during key steps of the
cannabis/hemp flowers sojourn are in order. This specification is needed to ensure safety, quality, and
weight stabilization of cannabis/hemp flower and will be used by purveyors who may store the
packaged, cured crop along the supply chain from packaging to another licensed operator or the end
user.
1. Scope responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.1 This standard specifies the environmental conditions,
mine the applicability of regulatory limitations prior to use.
such as temperature, humidity, and lighting under which
1.8 This international standard was developed in accor-
cannabis/hemp flowers in fresh format intended for human use
dance with internationally recognized principles on standard-
are packaged to be stored to ensure the safety, quality, and
ization established in the Decision on Principles for the
weight stabilization of the packaged flower.
Development of International Standards, Guides and Recom-
1.1.1 This specification does not apply to frozen cannabis/
mendations issued by the World Trade Organization Technical
hemp.
Barriers to Trade (TBT) Committee.
1.1.2 This specification does not apply to cannabis/hemp
intended for extraction.
2. Terminology
1.2 Thisspecificationappliestocontrollingtheenvironment
2.1 Definitions of Terms Specific to This Standard:
surrounding packaged cannabis/hemp flower.
2.1.1 environmental conditions, n—the atmosphere immedi-
1.3 This specification is to be followed by licensed opera-
atelysurroundingthecannabis/hempflower,whethercontained
tors in the cannabis/hemp space who move the packaged within the package in which the flower is contained, or in the
crop(s) through the distribution supply chain to another li-
larger space surrounding the package containing the flower.
censed operator or to the end user.
2.1.2 mean kinetic temperature, n—a simplified way of
1.4 Purveyors of cannabis/hemp flower include, but are not expressing the overall effect of temperature fluctuations during
storage or transit of perishable goods.
necessarily limited to: the packager, transportation companies,
warehousing operations, and retail operations. 2.1.2.1 Discussion—The MKT is widely used in the phar-
maceutical industry. The mean kinetic temperature can be
1.5 Security of the packaged cannabis/hemp flower while in
2
expressed as :
storage is not within the scope of this specification.
~∆H/RT ! ~∆H/RT ! ~∆H/RT !
1 2 n
T 5 ∆H/R/-ln@t e 1 t e 1 … 1 t e ⁄t 1 t
K 1 2 n 1 2
1.6 This specification is intended to remain valid until
1 … 1 t # (1)
ownership of the packaged cannabis/hemp flower is transferred n
to another licensed operator or to the final consumer.
where:
1.7 This standard does not purport to address all of the
T = the mean kinetic temperature in degrees Kelvin,
K
–1
safety concerns, if any, associated with its use. It is the
∆H = the activation energy (in kJ mol ),
-1 –1
R = the gas constant (in J mol K ),
1
This specification is under the jurisdiction of ASTM Committee D37 on
CannabisandisthedirectresponsibilityofSubcommitteeD37.04onProcessingand
2
Handling. USP-NF, Mean Kinetic Temperature in the Evaluation of Temperature Excur-
Current edition approved June 15, 2022. Published August 2022. DOI: 10.1520/ sions During Storage and Transportation of Drug Products, <1079.2>, 2020. DOI:
D8423-22 https://doi.org/10.31003/USPNF_M13855_02_01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D8423−22
containers, with hermetically sealed packaging and/or with
T to T = the temperatures at each of the sample points in
1 n
devices within the package into which the cannabis/hemp is
degrees Kelvins, and
packaged.
t to t = time intervals at each of the sample points.
1 n
2.1.3 relative humidity, n—the relative humidity (RH) of an 6.2 The temperature of the environment immediatel
...

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1.1 Specification D8423 covers the environmental conditions, such as temperature, humidity, and lighting under which the cured dry cannabis/hemp flowers packaged in fresh format and intended for human use can be maintained in storage to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the purveyor of storage of cannabis/hemp can meet those specifications.  
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5.1 The sample preparation procedure for comminution impacts other downstream processes such as extraction and sonication, which ultimately affects the total analytical error (TAE) and measurement uncertainty.  
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1.1 In this guide, the basic steps in obtaining a test portion sample of either dried cannabis/hemp inflorescence are outlined.  
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Standard Guide for Requirements for Medical-related Professionals within the Cannabis and Hemp Industries

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5.1 As patient use of cannabis and hemp for medical purposes increases and medical professionals are increasingly called upon to provide medical advice, the following requirements and expectations within the medical profession are increasingly significant, requiring:  
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5.1.2 Clarity by medical professionals on the legal restrictions in their area of jurisdiction to ensure compliance, and  
5.1.3 Development of qualified training and certificate programs to ensure safe and quality healthcare for patients.  
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5.2.1 Provide a general overview of the BoK required for the professions listed in Section 7; and  
5.2.2 Provide recommendations to form the foundation for training and subsequent recognition/certificate systems that enable consumers, employers, organizational management, government agencies, and others who rely upon medical professionals to distinguish between qualified and non-qualified workers.  
5.2.3 Recommend requirements that agencies can use to develop and document the specific criteria used for training or certificate programs.  
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SCOPE
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ASTM
ASTM D8469-22(Test Method)
Standard Test Method for Analysis of Multiple Elements in Cannabis Matrices by Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

SIGNIFICANCE AND USE
5.1 Medical and/or recreational marijuana (cannabis) has been legalized for adult use in many countries and states within the USA (5). Many jurisdictions that permit the use of medicinal and recreational marijuana require testing of cannabis and associated products to ensure safety from contaminants, especially the toxic “big four” elements such as As, Cd, Hg, and Pb (6), and other metals worthy of consideration (6). These heavy metals can accumulate in plants grown in polluted soils or contamination can occur during the manufacturing process (7). In addition to ensuring product safety, the analysis of mineral and other trace elements is required for labeling purposes when these products are sold as nutritional supplements. Trace element analysis of plant and nutritional supplement materials is a well-established application (8). Following acidic digestion to break down the plant-based samples' primary components, ICP-MS is often used for quantitative analysis because of its multi-element capability, high sensitivity, speed, robustness, and wide dynamic range.  
5.2 This test method covers the rapid determination of multiple elements in cannabis sample digests. The elements include the priority toxic elements (As, Cd, Hg, and Pb), as well as elements required by some states and elements of interest in the cannabis community (V, Cr, Cu, Zn, Sb, Ba, Se, Ag, Na, Al, K, Mn, Fe, Co, Ni, Mo, Tl, Th, and U). Irrespective of the number of elements being measured, test times are approximately a few minutes per test specimen, and detectability for most elements is in the low- to sub-ppb range.
SCOPE
1.1 This test method uses inductively coupled plasma mass spectrometry (ICP-MS) to determine multiple trace elements in cannabis and cannabis-related matrices following sample preparation using microwave-assisted acid digestion. This test method is applicable to the quantification of trace levels of elements in dried plant materials, concentrates, oils, extracts, tinctures of cannabis and cannabis-related products. Other matrices may be added provided that the lab validates the extra matrices using Practice D8282. Details are provided on the validation of both the sample preparation procedure and analytical method using certified reference materials (CRMs) and validation of the analytical method using spike recovery testing of several cannabis based samples.  
1.2 This test method should be used by analysts experienced in the use of microwave digestion and ICP-MS, matrix interferences, and procedures for their correction or reduction, and should only be used by personnel trained in the handling, preparation, and analysis of samples for the determination of trace elements in cannabis and cannabis products (1).2 This test method was developed using a single quadrupole ICP-MS equipped with a collision/reaction cell (CRC) that can be pressurized with helium (He) gas for the removal of polyatomic interferences using kinetic energy discrimination (KED). This test method can also be run using a triple quadrupole or “tandem” mass spectrometer (MS/MS) ICP-MS instrument, which is fitted with CRC technology. The ICP-MS method accounts for polyatomic interferences, which are the most common spectral overlaps in ICP-MS, isobaric interferences, and any potential doubly-charged ion interferences (M2+) that may arise from the presence of rare earth elements (REEs) in the samples, as the REE2+ ion interferences can affect the accuracy of the measurement of arsenic (As) and selenium (Se) in the samples. Table 1 lists elements for which the test method applies along with recommended analytical masses, and secondary masses for some elements. The priority toxic elements arsenic (As), cadmium (Cd), mercury (Hg), and lead (Pb), also sometimes referred to as the “big four” toxic trace elements are listed separately because of their toxicity, as discussed in 5.1.  
1.3 Certified reference materials (CRMs) should be matrix matc...

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