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ASTM D8197-18

(Specification)

Standard Specification for Maintaining Acceptable Water Activity (aw) Range (0.55 to 0.65) for Dry Cannabis Flower

Standard Specification for Maintaining Acceptable Water Activity (<emph type="ital">a<inf >w</inf></emph>) Range (0.55 to 0.65) for Dry Cannabis Flower

SCOPE
1.1 This specification covers the recommended range of aw suitable for safe and efficacious storage of cannabis flowers or portions thereof.  
1.2 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.  
1.3 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
Historical
Publication Date
14-May-2018
ICS
65.020.20 - Plant growing
Technical Committee
D37 - Cannabis
Drafting Committee
D37.04 - Processing and Handling
Current Stage
Ref Project

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ASTM D8197-18 - Standard Specification for Maintaining Acceptable Water Activity (<emph type="ital">a<inf >w</inf></emph>) Range (0.55 to 0.65) for Dry Cannabis FlowerASTM D8197-18 - Standard Specification for Maintaining Acceptable Water Activity (<emph type="ital">a<inf >w</inf></emph>) Range (0.55 to 0.65) for Dry Cannabis Flower
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ASTM D8197-18 - Standard Specification for Maintaining Acceptable Water Activity (<emph type="ital">a<inf >w</inf></emph>) Range (0.55 to 0.65) for Dry Cannabis Flower
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:D8197 −18
Standard Specification for
Maintaining Acceptable Water Activity (a ) Range (0.55 to
w
1
0.65) for Dry Cannabis Flower
This standard is issued under the fixed designation D8197; 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 concept of water activity is more than 50 years old. For many years, researchers tried to equate
bacterial growth potential with water content. William Jones Scott showed in 1953 that microorgan-
2
isms have a limiting a level for growth, thus being the first to establish that bacterial growth
w
correlated with water activity, not water content of organic materials. It is now generally accepted that
a is more closely related to the microbial, chemical, and physical properties of foods and other
w
3
natural products than is total moisture. It is firmly established that growth of specific microbes and
4,5
metabolism of microbe associated toxins are inhibited at or below specific water activity values.
Totalwatercontent(moisture)measurementsdonotnecessarilyreflectwateravailableformicrobial
growth and thus are an inaccurate means for controlling microbial growth, because the water content
sufficientformicrobialgrowthisdependentonthesubstancebeingtested.Wateractivitymeasurement
is more accurate than total water content measurement as it relates directly to the water available (in
liquid form) to microbes and is constant relative to the particular microbe, regardless of the substance
being tested.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This specification covers the recommended range of a
w
mendations issued by the World Trade Organization Technical
suitable for safe and efficacious storage of cannabis flowers or
Barriers to Trade (TBT) Committee.
portions thereof.
1.2 This standard does not purport to address all of the
2. Referenced Documents
safety concerns, if any, associated with its use. It is the
6
responsibility of the user of this standard to establish appro- 2.1 ASTM Standards:
priate safety, health, and environmental practices and deter- D8196 Practice for Determination of Water Activity (a )in
w
mine the applicability of regulatory limitations prior to use. Cannabis Flower
1.3 This international standard was developed in accor-
dance with internationally recognized principles on standard- 3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 water activity, a ,n—the partial vapor pressure of
1
w
This specification is under the jurisdiction of ASTM Committee D37 on
CannabisandisthedirectresponsibilityofSubcommitteeD37.04onProcessingand water in a substance divided by the partial vapor pressure of
Handling.
pure water at the same temperature which is calculated by
Current edition approved May 15, 2018. Published May 2018. DOI: 10.1520/
dividingthepartialvaporpressureofwaterinthesubstance(P)
D8197-18
2
by the partial vapor pressure of pure water at the same
Scott,W.J.,WaterrelationsofStaphylococcusaureusat30°. Australian Journal
of Biological Sciences6, 1953, pp 549-564.
temperature (P ), i.e., a = P/(P ). This describes quantita-
o w o
3
Chirife, J. and Fontana, A. J. (2007) Introduction: Historical Highlights of
tivelythecapabilityofthecannabisflowerinasealedcontainer
Water Activity Research, in Water Activity in Foods: Fundamentals and Applica-
to affect the humidity of the container’s headspace air.
tions (eds G. V. Barbosa-Cánovas, A. J. Fontana, S. J. Schmidt and T. P. Labuza),
Blackwell Publishing Ltd, Oxford, UK. doi: 10.1002/9780470376454.ch1
4
Russell, N.J., Leistner, L., and Gould, G.W. Solutes and Low WaterActivity in
Food Preservatives ed N.J. Russell and G.W. Gould, Springer 2012, pp119ff.
5 6
Naresh Magan, David Aldred, Post-harvest control strategies: Minimizing For referenced ASTM standards, visit the ASTM website, www.astm.org, or
mycotoxins in the food chain, International Journal of Food Microbiology, Volume contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
119, Issues 1–2, 2007, Pages 131-139, ISSN 0168-1605, https://doi.org/10.1016/ Standards volume information, refer to the standard’s Document Summary page on
j.ijfoodmicro.2007.07.034. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D8197−18
4. Significance and Use 5. Testing
4.1 This specification is designed for use on cannabis flower 5.1 Refer to Practice D8196.
by cannabis producers, processors, disp
...

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1.1 This terminology is a compilation of definitions of technical terms used in the cannabis industry. Terms that are generally understood or adequately defined in other readily available sources are not included.  
1.2 When a term is used in an ASTM document for which Committee D37 is responsible it is included only when judged, after review by Subcommittee D37.91, to be a generally usable term.  
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4.1 Product wastage will be reduced if spoilage is avoided or the potential for spoilage is identified earlier in the process. High moisture can result in conditions favorable to microbial growth, mold, and conditions leading to rancidity.  
4.2 Testing for moisture content can assist in proactively managing damage to seed before it is not rectifiable or provide information to retarget seed to other feasible by-product streams.
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Standard Guide for Sample Preparation of Cannabis and Hemp Inflorescence for Laboratory Analysis

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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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5.3 There are many different types of hardware technologies that address the comminution of dried cannabis or hemp; however, the list of devices is exhaustive and thus beyond the scope of this guide. See Table 3 and Table 4  (16-18) for a summary of different milling technologies. Distinctions among various pieces of equipment often relate to the type, mass, and size/shape of the sample (dry, fibrous) for which each is most effective. In addition, there may be economic reasons for mill selection, that is, the sample throughput of the testing laboratory (number of samples per day), access to cryogenics, and sample mass requirements.    
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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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ASTM D8197-22(Specification)
Standard Specification for Maintaining Acceptable Water Activity (aw) Range (0.55 to 0.65) for Dry Cannabis Flower Intended for Human/Animal Use

ABSTRACT
This specification prescribes the recommended range of water activity (aw) suitable for safe and efficacious storage of cannabis flowers or portions thereof. Water activity (aw) is defined as the partial vapor pressure of water in a substance divided by the partial vapor pressure of pure water at the same temperature, which can be calculated by dividing the partial vapor pressure of water in the substance by the partial vapor pressure of pure water at the same temperature. This describes quantitatively the capability of the cannabis flower in a sealed container to affect the humidity of the container's headspace air. aw shall be less than 0.65 to ensure against undesirable growth of microorganisms such as mold, and shall be greater than 0.55 to ensure against physical damage (breakage) in routine handling and storage. If aw exceeds 0.68, further drying of the cannabis flower(s) shall be required to ensure that the aw is in the range 0.55–0.65. If aw is less than 0.68, co-storage with a salt-based aw (relative humidity) control sachet(s) designed to maintain the relative humidity between 0.55 to 0.65 can effectively bring the stored cannabis flower(s) into the specified 0.55–0.65 range. Storing cannabis flower with appropriately designed aw (relative humidity) salt-based control sachets intended to ensure a relative humidity of 0.55 to 0.65 in sealed containers can maintain the optimum storage conditions.
Maintaining the requisite aw throughout the supply chain from completion of drying through merchandising ensures safety and quality for the consumer.
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4.6.5 Supplier performance and risk management.  
4.6.6 Supplier relationship management.  
4.6.7 Supplier offboarding.  
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1.3 This practice provides a process for supplier management in Section 5 and criteria for supplier evaluation in Section 6.  
1.4 Nothing in this practice shall preclude observance of federal, state, or local regulations which may be more restrictive or have different requirements.  
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ASTM D8196-22(Practice)
Standard Practice for Determination of Water Activity (aw) in Cannabis Flower

SIGNIFICANCE AND USE
5.1 This practice is designed for use on cannabis flower by cannabis producers, processors, dispensers, testing laboratories, and end users. aw testing at any point in the supply chain is an important element in ensuring the safety and quality of cannabis flower. Testing can occur spontaneously at any point in the supply chain by regulatory agencies, suppliers, and customers.  
5.2 This practice is an important endpoint in determining whether a cannabis flower sample is being stored under optimal storage conditions (see Specification D8197).  
5.3 Analysis of water activity should be considered an important quality control step in ensuring a cannabis flower sample is being stored under optimal storage conditions to prevent mold and/or other microbiological growth and/or breakage.  
5.4 Maintaining the requisite aw throughout the supply chain from completion of drying through merchandising ensures safety and quality for the consumer.  
5.5 Water activity is used in many cases as a critical control point for Hazard Analysis and Critical Control Points (HACCP) programs. Controlling aw should not be seen as a kill step.5 Rather control of aw focuses on preventing the growth and proliferation of microorganisms.  
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1.1 This practice covers the recommended procedure for determining the water activity (aw) of a cannabis flower sample.  
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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.
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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.  
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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  
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Standard Test Method for Determination of Cannabinoids in Cannabis Raw Materials and Resin Cannabis Products by Gas Chromatography and Flame Ionization Detection

SIGNIFICANCE AND USE
5.1 Gas chromatography and flame ionization detection provides a rapid means to identify and quantify cannabinoids in a variety of samples of interest. This test method allows producers of cannabis products to improve and optimize the quality of their products. For example, hemp extractors can use it to determine the efficiency of extraction processes and to verify that products meet regulatory requirements, ensuring safety and quality of products.  
5.2 Cannabinoids, such as CBD and THC can be monitored throughout the production process. The determination of Δ9-THC is often required for regulatory purposes and the determination of other THC isomers is often of interest. The United Nations Office on Drugs and Crime provides experimental details and guidance for use of GC to analyze cannabis related samples, including conditions suitable for decarboxylation of cannabinoid acids.3  
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1.1 This test method covers the analysis of cannabinoids in cannabis products by gas chromatography (GC) and flame ionization detection (FID).  
1.2 This test method is applicable to cannabis raw materials and resin cannabis products as defined in Guide D8245, including those from hemp. Such material includes: biomass; plant material; flowers; resins; extracts; distillates; recovered solvents; and other intermediate processing material. The applicable concentration range of analysis will vary to some extent depending on the nature of the sample, for instance measurement of delta-9-tetrahydrocannabinol (Δ9-THC) for regulatory purposes in hemp would require calibration to lower concentration levels compared to measurement of CBD in its isolate; however, in most cases, the test method is applicable to the determination of major and minor cannabinoids above about 0.1 mass% in concentration. Dilution of sample solutions is used to adjust concentrations to fall within appropriate calibration curves. Particular emphasis is placed on the determination of Δ9-THC for regulatory compliance purposes and control. This test method can measure any cannabinoid that is eluted and detected from a GC column with sufficient resolution from any interfering compounds. Typical cannabinoids of interest that can be determined by this test method are shown in Table 1. Use of an HPLC technique is recommended if individual measurement of acids, such as THCA, is required.  
1.3 The test method does not purport to identify all individual cannabinoids; however, individual users can adapt this test method for specific custom analyses to meet their needs.  
1.4 Units—Values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.5 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 t...

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ASTM
ASTM D8403-21(Practice)
Standard Practice for Certificate Programs within the Cannabis and Hemp Industries

SIGNIFICANCE AND USE
4.1 Certificate programs within the cannabis/hemp industries are offered by community colleges and universities, government agencies, employers, independent for-profit training organizations, and professional and trade associations. With the growth of these industries, an increased need for certificates is expected. While quality guidelines do exist for continuing education and training providers in general (for example, ANSI/IACET 1-2019), and for entities offering personnel certification programs (for example, ANSI/ISO/IEC 17024:2017), currently, no guidelines exist specifically to aid entities offering certificate programs within the cannabis industry. This practice aims to standardize and improve the quality of certificates and has been developed to:  
4.1.1 Provide certificate program developers and certificate issuers guidelines for quality program development and administration;  
4.1.2 Form the foundation for a recognition or certification system, or both, that enable consumers, employers, government agencies, and others who rely upon a skilled workforce to distinguish between qualified and unqualified workers; and  
4.1.3 Assist stakeholders in differentiating between certificate programs from personnel certifications.  
4.2 In a certificate program, an individual participates in a learning event or series of events designed to assist him or her in achieving specified learning outcomes within a defined scope; the individual receives a certificate only after verification of successful completion of all program requisites including but not limited to an assessment of learner attainment of intended learning outcomes.  
4.3 In contrast, in a certificate program, the learning event(s) and the assessment(s) are both developed and administered by the certificate issuer. There is an essential link between them. The learning event(s) are designed to help participants achieve learning outcomes and the assessments are designed to evaluate the learners’ attainment...
SCOPE
1.1 This practice provides protocols to certificate issuers for developing and administering certificate programs for stakeholders within the cannabis and hemp industries for determining best practices for administering professional or procedural certificate programs within the industries.  
1.2 This practice includes requirements for both the certificate issuer and requirements for the specific certificate programs issuing certificates.  
1.3 This practice provides the foundation for recognizing or certificate issuers to issue certificates to individuals after completing a certificate program.  
1.4 This practice addresses certificate programs for entities seeking certificates and inclusive of individuals, groups, or organizations and is applicable to training-based certificates for personal development and organizational-related certificates to existing standards or guidelines.  
1.5 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.  
1.6 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.

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