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ASTM D8282-19

(Practice)

Standard Practice for Laboratory Test Method Validation and Method Development

Standard Practice for Laboratory Test Method Validation and Method Development

SIGNIFICANCE AND USE
4.1 The demonstration that a method of analysis is fit for its intended purpose and application is done through method characterization and validation.  
4.2 Resulting SOPs should be reproducible under the same conditions by a different analyst working in a different laboratory.  
4.3 Test methods are designed to assess one or more of the following product attributes: identity, strength or concentration, quality, and purity.  
4.4 The steps of this practice contain the basic procedures for performing a TMC, a TMV, and a TMT. It is not imperative that each procedural step be followed in the designated order, but the ordered sequence is a logical progression of the steps for performing a TMC, a TMV, and a TMT.
SCOPE
1.1 The quality, efficacy, and safety of cannabis and products containing cannabis extracts shall be evaluated by validated testing methodologies used by trained staffed utilizing qualified instruments and/or materials.  
1.2 This practice provides the cannabis industry with guidance for the development and validation of testing methods that adequately evaluate cannabis and products containing cannabis extracts for quality, efficacy, and consumer health safety in the absence of validated methods from agencies. This includes, but is not limited to, the potency of active substances and adulteration, including impurities stemming from potential adulteration during agricultural or manufacturing processes or both (for example, pesticides, residual solvents, and the presence of fungus and microorganisms) before product approval and release for use. Depending on the methodology and precision and accuracy required, these methods may be both qualitative or quantitative.  
1.3 This practice shall define the procedures for test method characterization (TMC), test method validation (TMV), and test method transfer/transfer of analytical procedures (TMT/TAP) of biological, chemical spectroscopic, and physical-based laboratory test methods.  
1.4 Depending on the nature of the test in question (chemical, microbiological, etc.) different variables will need to be considered for validation. The particular variables subject to consideration are beyond the scope of this document. Refer to Guide E2857 for more guidance.  
1.5 This standard does not consider the specifics of acceptable test method limits and users should consult relevant standard literature to determine the appropriate test parameters.  
1.6 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.  
1.7 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
31-Aug-2019
ICS
11.120.99 - Other standards related to pharmaceutics
65.020.20 - Plant growing
Technical Committee
D37 - Cannabis
Drafting Committee
D37.03 - Laboratory
Current Stage
Ref Project

Relations

Referred By
ASTM D8309-21 - Standard Guide for Stability Testing of Cannabis-Based Products
Effective Date
01-Sep-2019
Referred By
ASTM D8222-21a - Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use of Cannabis/Hemp Products
Effective Date
01-Sep-2019
Referred By
ASTM D8439-22 - Standard Specification for Medicinal-use Cannabis Inflorescence
Effective Date
01-Sep-2019
Referred By
ASTM D8244-21a - Standard Guide for Analytical Laboratory Operations Supporting the Cannabis/Hemp Industry
Effective Date
01-Sep-2019
Referred By
ASTM D8375-23 - Standard Test Method for Determination of Cannabinoid Concentration in Dried Cannabis and Hemp Raw Materials using Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
Effective Date
01-Sep-2019
Referred By
ASTM D8469-22 - Standard Test Method for Analysis of Multiple Elements in Cannabis Matrices by Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Effective Date
01-Sep-2019
Referred By
ASTM D8493-23 - Standard Guide for Sample Preparation of Cannabis and Hemp Inflorescence for Laboratory Analysis
Effective Date
01-Sep-2019
Referred By
ASTM D8399-23 - Standard Test Method for Multi-residue Analysis of Pesticides in Dried Cannabis and Hemp Raw Materials Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Effective Date
01-Sep-2019
Referred By
ASTM D8442-22 - Standard Test Method for Determination of Cannabinoids in Cannabis Raw Materials and Resin Cannabis Products by Gas Chromatography and Flame Ionization Detection
Effective Date
01-Sep-2019

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ASTM D8282-19 - Standard Practice for Laboratory Test Method Validation and Method Development
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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: D8282 − 19
Standard Practice for
Laboratory Test Method Validation and Method
1
Development
This standard is issued under the fixed designation D8282; 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 1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 The quality, efficacy, and safety of cannabis and prod-
ization established in the Decision on Principles for the
ucts containing cannabis extracts shall be evaluated by vali-
Development of International Standards, Guides and Recom-
dated testing methodologies used by trained staffed utilizing
mendations issued by the World Trade Organization Technical
qualified instruments and/or materials.
Barriers to Trade (TBT) Committee.
1.2 This practice provides the cannabis industry with guid-
anceforthedevelopmentandvalidationoftestingmethodsthat
2. Referenced Documents
adequately evaluate cannabis and products containing cannabis
2
2.1 ASTM Standards:
extracts for quality, efficacy, and consumer health safety in the
E2857 Guide for Validating Analytical Methods
absenceofvalidatedmethodsfromagencies.Thisincludes,but
2.2 Other Documents:
is not limited to, the potency of active substances and
United States 40 CFR Appendix B to Part 136 Definition
adulteration, including impurities stemming from potential
and Procedure for the Determination of the Method
adulteration during agricultural or manufacturing processes or
3
Detection Limit
both (for example, pesticides, residual solvents, and the pres-
USP 1224 Transfer of Analytical Procedures
ence of fungus and microorganisms) before product approval
USP 1225 Validation of Compendial Procedures
and release for use. Depending on the methodology and
ICH Q2(R1) –Validation ofAnalytical Procedures:Text and
precision and accuracy required, these methods may be both
Methodology
qualitative or quantitative.
1.3 This practice shall define the procedures for test method 3. Terminology
characterization (TMC), test method validation (TMV), and
3.1 Definitions:
test method transfer/transfer of analytical procedures (TMT/
3.1.1 acceptance criteria, AC, n—specification(s) that shall
TAP) of biological, chemical spectroscopic, and physical-
be met by a test sample or matrix specific method to be
based laboratory test methods.
considered suitable or validated for use, respectively.
1.4 Depending on the nature of the test in question
3.1.1.1 Discussion—State-specific criteria shall be met as
(chemical, microbiological, etc.) different variables will need
applicable.
to be considered for validation.The particular variables subject
3.1.2 accuracy, n—the closeness of agreement between a
to consideration are beyond the scope of this document. Refer
test result and an accepted reference value.
to Guide E2857 for more guidance.
3.1.2.1 Discussion—The term accuracy, when applied to a
1.5 This standard does not consider the specifics of accept-
set of test results, involves a combination of a random
able test method limits and users should consult relevant
component and of a common systematic error or bias compo-
standardliteraturetodeterminetheappropriatetestparameters.
nent.
1.6 This standard does not purport to address all of the
3.1.3 addendum, n—document written to make minor up-
safety concerns, if any, associated with its use. It is the
dates to an existing completed protocol or report.
responsibility 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. 2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
This practice is under the jurisdiction of ASTM Committee D37 on Cannabis the ASTM website.
3
and is the direct responsibility of Subcommittee D37.03 on Laboratory. Available from U.S. Government Printing Office, Superintendent of
Current edition approved Sept. 1, 2019. Published October 2019. DOI: 10.1520/ Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
D8282-19. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D8282 − 19
3.1.3.1 Discus
...

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ASTM D8270-23b(Terminology)
Standard Terminology Relating to Cannabis

SCOPE
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.  
1.3 Definitions that are identical to those published by other ASTM committees or other standards organizations are identified with the committee number (for example, D20) or with the abbreviation of the name of the organization (for example, IUPAC, International Union of Pure and Applied Chemistry).  
1.4 A definition is a single sentence with additional information included in discussions.  
1.5 Definitions are followed by the committee responsible for the standard(s) (for example, [D37.01]) and standard designation(s) in which they are used (for example, D8219).  
1.6 Abbreviated Terminology:  
1.6.1 Abbreviated terminology is intended to provide uniform contractions of terms relating to cannabis that have evolved through widespread common usage. The compilation in this standard has been prepared to avoid the occurrence of more than one abbreviated term for a given cannabis term and to avoid multiple meanings for abbreviated terms.  
1.6.2 The abbreviated terminology and descriptions in this standard are intended to be consistent with usage in the cannabis industry and the standards under D37 jurisdiction. Other ASTM committees may assign a different word-phrase description to the same abbreviated terminology. In such cases, the abbreviated terms in this standard shall apply to usage in D37 standards, or if widespread misunderstanding could result from conflicting abbreviated terminology descriptions, the abbreviated terminology for the word-phrase shall not be used in D37 standards.  
1.6.3 Acronyms and Initialisms—A word formed from the letters or parts of words of a longer word-phrase, usually from the initial letters or parts of the words. An acronym is pronounced as a word (for example, radar for radio detection and ranging). An initialism is pronounced as a series of letters (for example, DOT for Department of Transportation).  
1.6.4 The acronym or initialism description is the origin word-phrase for the acronym or initialism, not a definition.  
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.

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ASTM D8493-23(Guide)
Standard Guide for Sample Preparation of Cannabis and Hemp Inflorescence for Laboratory Analysis

SIGNIFICANCE AND USE
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.  
5.2 Factors that may influence the sample preparation process include the prevention of cross-contamination (carryover) from a prior sample and an inadequate cleaning procedure between preparation of samples, poor sample handling, storage (sample preservation), and moisture content (drying methods) of plant material being greater than 15 % (15). Samples with high moisture content are hard to process completely and may yield lower analyte (that is, cannabinoid) concentration during extraction and further processing. Lastly, water activity Specification D8197 is recommended, activity (aw) range (0.55 to 0.65) for dry cannabis or hemp flower or both.  
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.    
5.4 In addition to sampling devices, this guide does not include the sample preparation of edibles, tinctures, oils/concentrates, beverages, and so forth in which the sample diversity poses significant sample preparation challenges to be put forward in additional work items.  
5.5 The sample size for comminution purposes is limited as the analytical testing portion required is often 500 times smaller than the bulk sample lot and not every testing laboratory is equipped to handl...
SCOPE
1.1 In this guide, the basic steps in obtaining a test portion sample of either dried cannabis/hemp inflorescence are outlined.  
1.2 Sample preparation depends on many factors including moisture (dryness) of the sample, the analyte to be measured, the concentrations/amounts, and the test method's precision and accuracy requirements. In this case, dried cannabis or hemp plant material require particle size reduction-comminution from a representative sample of which the final analytical testing portion is determined by the employed testing method. Local regulatory guidelines often dictate both the representative sample that is taken from the bulk material (harvest batch) and the final mass of the test portion (for example  
1.3 This guide will not purport to meet every local and state jurisdiction since different regulatory requirements vary; the local/state requirements are at the discretion of the user to follow and interpret.  
1.4 Units—The 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 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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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.  
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Standard Guide for Requirements for Medical-related Professionals within the Cannabis and Hemp Industries

SIGNIFICANCE AND USE
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:  
5.1.1 Availability by patients to qualified medical professionals who can provide safe and objective advice on the medical use of cannabis and hemp,  
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.  
5.2 The primary objectives of this guide are as follows:  
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.  
5.3 Users of this guide shall document deviations from the recommended requirements to inform their clients of the criteria applied in either the training or the certificate programs offered. As the cannabis and hemp industries and medical guidelines mature, this guide will be updated to reflect current thinking and requirements.  
5.4 The Bok elements are applicable to certificate programs, while the BoK, experiential and educational elements are applicable to certification process requirements.
SCOPE
1.1 This guide can provide certification bodies, training providers, employers, and certificate issuers, with best-practice guidance for administering their respective programs for medical-related professions within the cannabis and hemp industries.  
1.2 This guide recommends requirements for experience, training, education, and the body of knowledge (BoK) necessary for medical-related professions within the cannabis and hemp industries listed in Table 1.  
1.3 For purposes of this guide, a medical professional is defined as a person qualified and licensed as required by the jurisdiction to provide guidance or recommendations regarding a person's health or fitness.  
1.4 This guide provides recommendations for articulating professional requirements for training and education or earning certificates. It is part of a series of guides denoting certification requirements for professions within the cannabis and hemp industries (Guides D8346, D8347, D8348), and supporting Practice D8403 for associated certificate programs.  
1.5 This guide's content does not supersede requirements for training or earning a certificate defined by jurisdictional entities such as government or other regional regulatory bodies.  
1.6 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.  
1.7 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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ASTM D8442-22(Test Method)
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  
5.3 Post-decarboxylated methodology is used. In decarboxylation, heat is used to liberate carbon dioxide from carboxylic acid cannabinoids, forming their corresponding neutral cannabinoids, for example, THC from THCA. It should be recognized that the hot temperature of the GC injection port itself is capable of effecting at least some decarboxylation (250 °C – Table 2), and many sample types, such as distillates, require no decarboxylation because it would have occurred during material processing. Therefore, some knowledge of sample properties and material processing is useful. Resulting determinations are for the total cannabinoid content of specific isomers, for example, total Δ9-THC. For those samples requiring decarboxylation, the method is validated per Practice D8282 through the use of reference materials, spike and recovery of knowns, or through comparison with LC results. For example, carrying out the decarboxylation procedure of a standard containing known amounts of CBDA and CBN should yield the correct amounts of CBD and CBN, where CBN is not significantly changed and the mass...
SCOPE
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.  
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ASTM D8400-21(Guide)
Standard Guide for Assessing Spoilage of Hemp Seed Intended for Human Consumption

SIGNIFICANCE AND USE
3.1 This guide provides a method for rapid, visual, on-site assessment of spoilage of hemp seed that will assist in managing food quality and productivity while maintaining consumer safety. It can be augmented with a number of laboratory tests to determine spoilage.  
3.2 This guide provides a method to identify hemp seed samples that are likely to spoil by quantifying discolored (dark yellow or brown) dehulled seed. Samples from lots/batches that display more than 2 % discolored2 dehulled seed are generally considered to be compromised.  
3.3 Laboratories providing certificates of analysis can validate this spoilage test. Used in conjunction with a peroxide value (PV) and FFA content or other methods, results will help determine the acceptability of a lot/batch of seed. In addition, a trained panel can complete organoleptic testing, but this should be used in combination with other tests.  
3.3.1 It is recommended that where possible, test results taken from samples are reported with a calculated margin of error to ensure statistical significance or relevant results.  
3.4 Product wastage will be reduced when spoilage is identified early, and decisions to re-target other viable uses may help assess pricing, discounts, and salvageable seed.
SCOPE
1.1 This guide covers the recommended steps for a visual assessment of spoilage in hemp seed intended for human consumption. Additional recognized laboratory tests can be completed as necessary to augment this guide.  
1.2 This guide applies to plant breeders, hemp seed producers, storage facilities, laboratories, and processors. This guide does not apply to hemp seed intended for planting.  
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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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ASTM D8343/D8343M-21(Practice)
Standard Practice for Measuring the Physical Properties of Cannabis/Hemp Pre-rolls

SIGNIFICANCE AND USE
4.1 This practice will specify the baseline physical properties of a pre-roll, including the weight of cannabis herbal material in the pre-roll, the length of the pre-roll, and the diameter of the pre-roll.  
4.2 This practice will provide clarity on the physical properties of cannabis pre-rolls.
SCOPE
1.1 This practice is intended to be used to identify the physical properties of a cannabis/hemp pre-roll.  
1.2 This practice shall apply to pre-rolls made using herbal material(s) from any type of a cannabis plant (that is, cannabis/hemp), regardless of the cannabinoid content. For the sake of brevity, the term “cannabis” shall be used henceforth to refer to any type of cannabis plant (cannabis/hemp).  
1.3 This practice helps to provide clarity on pre-roll preparation and sampling to identify, measure, and report the length, diameter, and weight of cannabis pre-rolls.  
1.4 This practice shall not be applicable to infused cannabis pre-rolls, which are outside the scope of this standard.  
1.5 Units—The values stated in either SI units or United States Customary Units (USC Units) are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. Metric units will be stated as standard and USC units will be shown in brackets relative to the metric units.  
1.6 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.  
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ASTM D8334/D8334M-20(Practice)
Standard Practice for Sampling of Cannabis/Hemp Post-Harvest Batches for Laboratory Analyses

SIGNIFICANCE AND USE
5.1 This standard will provide best practices for the sampling of harvested cannabis inflorescence with the intent to assure representative sampling.  
5.2 The laboratory results and their respective harvest batch associations have implications and significance to regulatory requirements, quality control considerations throughout the product’s life cycle, and the safety of the consumers who may be adversely affected by consumption of product that was not tested in a homogeneous manner (3).  
5.3 This standard does not address the appropriate sampling of processed cannabis materials such as such as extracts, seeds, edibles, topicals, etc.  
5.4 This standard addresses the sampling of cannabis inflorescence destined for human or animal consumption.  
5.5 This standard does not address pre-harvest field sampling or large untrimmed or unprocessed harvest batches.
SCOPE
1.1 Cannabis harvested materials require sampling strategies throughout their life cycle, from cultivation to the end consumer. For purposes of this standard, the term cannabis is inclusive of all cannabis inflorescence, including hemp varieties. The qualitative and quantitative characteristics of cannabis/hemp for human or animal consumption has safety implications throughout the life cycle from cultivation to end consumer. This standard provides best practice procedures and protocols for sampling batches of harvested cannabis inflorescence. Cannabis/hemp materials often exhibit variability across different parts within the same plant or across different plants within the same cultivar, or both, (1, 2).2 Thus, sampling strategies are required which yield a representative a sample across a harvest batch. Representative sampling is required to ensure that the qualitative and quantitative test results accurately reflect cannabinoid identification, potency, identification and concentration of terpenes, concentration of trace metals, microbiological activity, mycotoxins, and concentration of pesticides across the batch.  
1.2 Where procedural aspects of this practice differ from local regulatory or jurisdictional requirements, the local regulatory or jurisdictional authority’s directives shall take precedence.  
1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.4 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.  
1.5 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.

  • Standard
    7 pages
    English language
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ASTM
ASTM D8220-20(Guide)
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.

  • Guide
    5 pages
    English language
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ASTM
ASTM D8205-20(Guide)
Standard Guide for Video Surveillance System

SIGNIFICANCE AND USE
3.1 The video surveillance system safeguards various areas considered critical to operations. The surveillance system uses cameras capable of capturing images and videos that can be compressed, stored, or sent over communication networks. The main difference between a digital video surveillance system and an analog video surveillance system is that a digital video surveillance system is capable of capturing and storing the video signal in a digital format. A digital video surveillance solution can be managed from anywhere and provide interoperability. The cameras can be networked and footage encrypted and digitally archived, which is considered crucial for most resin cannabis businesses because the video feed can be secured and shared with government authorities.
SCOPE
1.1 This guide covers the recommended video surveillance system for protecting resin cannabis, resin cannabis products, resin cannabis waste, currency, people, property, and assets.  
1.2 Units—The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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 as defined by the Authority Having Jurisdiction (AHJ) 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.

  • Guide
    3 pages
    English language
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