D37 - Cannabis

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.
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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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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.

SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers’ sojourn are in order.  
4.2 This standard is intended to assure safety, quality, and weight stabilization of packaged cannabis/hemp flower during transit operations.  
4.3 This standard is intended to be used by purveyors who move the packaged cured flower between licensed operators or to the end user.  
4.4 This standard is intended to be used by samplers and testing laboratories transporting samples to a laboratory to assure that samples analyzed represent as accurately as possible, the material that was gathered to provide the sample for analysis.
SCOPE
1.1 Specification D8432 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 transit to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the purveyor of transportation of cannabis/hemp can meet those specifications.  
1.1.1 This standard does not apply to frozen cannabis/hemp.  
1.1.2 This standard does not apply to cannabis/hemp intended for extraction.  
1.2 This standard applies to controlling the environment surrounding packaged cannabis/hemp flower in transit, either within the package itself or in the environment surrounding the package, or both.  
1.3 This standard 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 transit is not within the scope of this standard.  
1.6 This standard 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 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this standard.  
1.8 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.  
1.9 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.

SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers’ sojourn are in order.  
4.2 This standard is intended to assure safety, quality, and weight stabilization of packaged cannabis/hemp flower during storage.  
4.3 This standard is intended to be used by purveyors who store the packaged cured flower between packaging and subsequent transfer to other licensed operators or to the end user.  
4.4 This standard is intended to be used by samplers and testing laboratories storing samples prior to laboratory analyses to assure that samples analyzed represent as accurately as possible, the material that was gathered to provide the sample for analysis.
SCOPE
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.  
1.1.1 This standard does not apply to frozen cannabis/hemp.  
1.1.2 This standard does not apply to cannabis/hemp intended for extraction.  
1.2 The standard applies to controlling the environment surrounding packaged cannabis/hemp flower during storage, either within the package itself or in the environment surrounding the package, or both.  
1.3 This standard 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 standard.  
1.6 This standard 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 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this standard.  
1.8 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.  
1.9 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.

SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers sojourn are in order.  
4.2 This guide is intended to assist in assuring safety, quality, and weight stabilization of cannabis/hemp flower during indoor packaging operations.  
4.3 This guide is intended to assist in assuring that packaged cannabis/hemp flower has a water activity of 0.55 to 0.65 per Specification D8197.  
4.4 This guide is intended to be used by purveyors who move the cured crop to consumer or non-consumer packaging used for distribution.
SCOPE
1.1 Specification D8450 specifies the environmental conditions, such as temperature, humidity, and lighting under which the cured, dry, cannabis/hemp flowers in fresh format intended for human use are to be packaged to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the packager of cannabis/hemp can meet Specification D8450.  
1.1.1 This guide does not apply to frozen cannabis/hemp.  
1.1.2 This guide does not apply to cannabis/hemp intended for extraction.  
1.2 This guide applies only to controlling an indoor environment (heat, cooling, humidity control, lighting) surrounding packaging operations. Outdoor operations are outside the scope of this guide and are not addressed.  
1.3 This guide can be used by licensed operators in the cannabis/hemp space who move the cured crop(s) into consumer or non-consumer packaging used for distribution.  
1.4 Security of the cannabis/hemp flower during the packaging process is not within the scope of this guide.  
1.5 This guide is intended to remain valid until the packaged cannabis/hemp flower is placed in storage or transit.  
1.6 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this guide.  
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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1.1 This specification shall define the label content and style and format specifications for consumer products containing cannabinoids sold in an adult-use or medicinal-use marketplace.  
1.2 This specification shall define clear product categories for which these specifications apply.  
1.3 This specification shall apply to all consumer products containing cannabinoids packaged, distributed, and sold in an adult-use or medicinal-use marketplace regardless of the methods of obtention (source) of the cannabinoids.  
1.4 This specification shall not apply to inhalable or topical consumer products containing less than 10 000 PPM (1 %) total cannabinoids2, of which, no more than 3000 PPM (0.3 %) shall be total THC3.  
1.5 This specification shall not apply to ingestible consumer products containing less than 250 PPM (0.025 %) total cannabinoids, of which, no more than 10 PPM (0.001 %) shall be total THC4.  
1.6 This specification shall not define the label specifications for approved dietary supplements, over-the-counter drugs, or pharmaceuticals containing cannabinoids.  
1.7 This specification shall not define the label specifications for non-consumer products containing cannabinoids such as bulk or in-process products.  
1.8 This specification shall not define the design characteristics for label material, adhesives, ink, or other features unrelated to label content or style, format, location, and prominence of elements.  
1.9 Where aspects of this specification differ from jurisdictional regulatory requirements, the stricter of the two shall take precedence.  
1.10 Where aspects of this specification conflict with jurisdictional regulatory requirements, the authority having jurisdiction shall take precedence.  
1.11 Units—The values stated in either SI units or US Customary 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.  
1.12 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.  
1.13 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.

SIGNIFICANCE AND USE
5.1 The analysis and reporting of pesticide content in all forms of cannabis raw material that is grown or processed or both, with the intent of ingestion or consumption, is required to address health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions where cannabis has been legalized for ingestion or consumption for medicinal or recreational purposes, or both. This test method is useful in providing quantitative results for the analytes listed in Table 1, which is a subset of the pesticide testing requirements found in regulatory documents for cannabis, not limited to and including Canada, many U.S. states where legalization has occurred, and the European Pharmacopeia (1-4). This test method may be appropriate for additional pesticide and growth regulator analytes, which may be added to those of Table 1 provided validation is performed in accordance with Practice D8282. Analytes may be removed from Table 1 without additional validation.
SCOPE
1.1 This test method allows for the concentration determination of the pesticides listed in Table 1 and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived (1, 2).2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those which can be classified as hemp. The procedure includes sub-sampling a ground, homogenous sample, liquid-solid extraction with acetonitrile:acetic acid (100:1, v:v), solid phase extraction with C18 SPE media, dilution in 3 mM ammonium formate in water with 0.1 % formic acid and 3 mM ammonium formate in methanol with 0.02 % formic acid in a 20:80 ratio (v:v) and analysis by LC-MS/MS. This procedure encompasses the entire process from sample preparation to analyte quantitation encompassing a range of 0.005 µg/g to 0.500 µg/g.  
Pyrethrins = Pyrethrin I and II
Spinetoram = Spinetoram J and L
Spinosad = Spinosyn A and D
Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 Table 1 lists the analytes measured by this test method.  
1.4 No recommendations found within this test method shall preclude observance of federal, state, or local regulations, which may be more restrictive or have different requirements.  
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.

SIGNIFICANCE AND USE
5.1 The analysis and reporting of cannabinoid content in cannabis and hemp is required to address human health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions. This test method is useful in providing quantitative results for up to seventeen cannabinoids in dried cannabis and hemp raw material samples.
SCOPE
1.1 This test method allows for the concentration determination of the cannabinoids listed in Table 1, and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived.2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those that can be classified as hemp. The procedure includes sub-sampling a ground, homogeneous sample, extraction with methanol:water (80:20, v:v),3,4 dilution in methanol and analysis by liquid chromatography tandem mass spectrometry (LC-MS/MS). The method allows for a wide-range of sample concentrations to be determined by using a 1000-fold calibration range and the option to perform multiple levels of sample dilution. The calibration curve is prepared in methanol over a range of 10 ng/mL to 10 000 ng/mL for all seventeen cannabinoids, or a subset of cannabinoids if desired, while the sample extracts are diluted in methanol into the calibration range.3,4,5 For example, a 1/500 dilution of sample extracts allows concentration determination over a range of 0.5 mg/g to 500 mg/g in cannabis. The method was validated with quality control samples prepared in methanol, a candidate certified reference material (CRM), and repeat extraction and analysis of cannabinoid samples.3  
Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 List of Measurable Analytes—See Table 1.  
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.

SIGNIFICANCE AND USE
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.
SCOPE
1.1 This guide can be used by hemp farmers, hemp seed processing companies, and hemp agricultural extension agents to help manage against potential seed spoilage during storage.  
1.2 This applies to broadacre production of hemp seed intended for human consumption.  
1.3 This guide does not apply to hemp plants grown indoors or for purposes other than for harvesting of hemp seed intended for food within outdoor production conditions.  
1.4 Units—The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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.

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...
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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.  
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.

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.
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.

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.  
5.6 This practice is designed for use by trained technical individuals with minimal knowledge of complex analytical chemistry procedures.
SCOPE
1.1 This practice covers the recommended procedure for determining the water activity (aw) of a cannabis flower sample.  
1.2 Units—The values stated in SI units are to be regarded as the standard. Water activity is a ratio, and thus is without unit designation.  
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.

SIGNIFICANCE AND USE
4.1 This practice is intended to be used by cannabis or hemp operators, or both, to establish good supplier lifecycle management practices.  
4.1.1 Without proper oversight, the quality and reliability of supplied materials, equipment, parts, software, or services can degrade. This can create issues that directly impact the operation's performance and remain undetected until customers experience a problem.  
4.1.2 Early identification and mitigation of risks within the supply chain are crucial to controlling costs and minimizing potential impacts on operations, customer experience, and business reputation. In general, costs are reduced when issues are prevented early and upstream in the supply chain.  
4.2 This practice applies to the cannabis or hemp horticulture, agriculture, processing, manufacturing, testing, and distribution operators and the many suppliers that provide materials, equipment, parts, software, or services to these operations.  
4.3 This practice provides operations and consultants supporting operations with the actions required to implement good supply and supplier management practices.  
4.4 Any supply chain operator can use this practice to conduct an internal gap assessment and risk analysis to identify opportunities for improvement.  
4.5 Certification bodies can use the standard to develop supplier audit programs.  
4.6 Section 5 provides details on the supplier lifecycle management process that includes the following seven activities:  
4.6.1 Supply and supplier information management.  
4.6.2 Supply identification and specifications.  
4.6.3 Supplier options, evaluation, and selection.  
4.6.4 Supplier onboarding.  
4.6.5 Supplier performance and risk management.  
4.6.6 Supplier relationship management.  
4.6.7 Supplier offboarding.  
4.7 To implement supplier management, follow the process in Sections 5 and 6. Start by applying the principles in this practice to a few supplies and suppliers and work through all of the step...
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1.1 This practice provides cannabis or hemp operations, or both, with methods, procedures, responsibilities, and criteria for supplier management practices to reliably receive supplies that meet specifications. Effective supplier management includes clear concise communication and comprehension between departments and business functions, that is, marketing, finance, operations, supply requirement analysis, supplier assessment or audits, supplier selection, backup suppliers, and supply/supplier information management.  
1.2 In this practice, the term cannabis can be substituted with the term hemp. This practice applies to industrial hemp operations, CBD operations, and as referred to by several authorities having jurisdiction, licensed marijuana operations.  
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.  
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.

SCOPE
1.1 This standard defines the specifications (appropriate tests, their analytical methods and acceptance criteria) for the identification, strength (for example, cannabinoid content), and purity (for example, limits for contaminants) for medicinal-use cannabis inflorescence.  
1.2 This specification references approved analytical methods used to verify the specifications, and in the absence of approved analytical methods, a suggested method for validating such specifications.  
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.

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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1.1 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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1.1 This specification establishes the maximum allowable E. coli and Salmonella microbial levels, moisture content, peroxide value (PV), free fatty acid (FFA) content, yeast and mold levels, representative heavy metals, total coliforms, foreign material, and discoloration for hempseed intended for human consumption.  
1.2 This specification applies to plant breeders, hempseed producers, seed cleaners, processors, wholesalers, regulatory bodies, and analytical laboratories. This specification does not apply to viable hemp seed intended for germination and planting, and does not set limitations for pesticide limits, or physical purity beyond foreign matter. See Note 1.
Note 1: Additional hazard limits and characterization of attributes will be assessed in future versions of this document.  
1.3 This specification describes minimum information required in a certificate of analysis.  
1.4 Where aspects of this specification differ from regional regulatory jurisdictional requirements, the jurisdictional authority’s directive shall take precedence.  
1.5 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.6 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.

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...
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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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1.1 This standard specifies the environmental conditions, such as temperature, humidity, and lighting under which cannabis/hemp flowers packaged in fresh format and intended for human use are to be maintained in transit to ensure the safety and quality 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 in transit.  
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 Security of the packaged cannabis/hemp flower while in transit is not within the scope of this specification.  
1.5 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.  
1.6 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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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.

SIGNIFICANCE AND USE
4.1 This practice is for any cannabis operation to use as a fundamental part of a robust quality management system (QMS).  
4.2 Regulators can use this practice to develop regulations that require the implementation of QMS principles, specifically management’s role and responsibilities. Further, regulators can use this practice to help build a checklist to evaluate management’s engagement and compliance with QMS based regulations.  
4.3 Auditors would use this practice to assess the level of management engagement with an operations QMS.  
4.4 Any cannabis operation that has implemented or seeks to implement a QMS would use this practice.
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1.1 This practice provides the management responsibilities for the implementation and oversight of a quality management system (QMS). It can be applied to all cannabis operations, including cultivation, manufacturing, labeling, dispensing, and distribution. This practice does not address the quality management system details, but rather focuses on the main considerations for management’s role in setting up a QMS. Guide D8222 provides an overview and some details about the components of a QMS. Other standards provide details on specific QMS components.  
1.2 The term GxP as used in this practice is meant to include those good practices in the activities included in 1.1; namely cultivation, manufacturing, distribution, and all the relevant functions associated with these activities (for example, purchasing, testing, storing, and so forth).  
1.3 Although this practice mentions the importance of health and safety, it is done so in the context of overall management responsibility. This practice does not address details of a health and safety system, but it identifies the importance of this as a management responsibility.  
1.4 This practice encompasses a single component of the QMS (management responsibilities) that, when combined with the other elements, satisfies the requirements of a complete QMS.  
1.5 The practices described in this standard are intended to apply to all products of a cannabis plant including those that can be classified as hemp and which contain cannabinoids and can be consumed/ingested via mouth, nose, skin (whether described as medicine, supplements, food, cosmetics, and so forth.).  
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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1.1 This standard specifies the environmental conditions, such as temperature, humidity, and lighting, under which cannabis/hemp flowers intended for human use are to be packaged to ensure the safety, quality, and weight stabilization of the packaged flower. This specification does not apply to frozen cannabis/hemp nor to cannabis/hemp intended for extraction.  
1.2 This specification applies only to controlling an indoor environment (heat, cooling, humidity control) surrounding packaging operations. Outdoor operations are outside the scope of this specification and are not addressed.  
1.3 This specification is to be followed by licensed operators in the cannabis/hemp space who move the cured crop(s) into consumer or non-consumer packaging used for distribution.  
1.4 Security of the cannabis/hemp flower during the packaging process is not within the scope of this specification.  
1.5 This specification is intended to remain valid until the packaged cannabis/hemp flower is placed in storage or transit.  
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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1.1 In this specification, the maximum allowable e.coli, salmonella spp, yeast and mold, foreign material, and total delta-9 tetrahydrocannabinol (THC) content is established for major hempseed products intended for human consumption. It also establishes acceptable ranges for moisture, peroxide value, and free fatty acid content, which help maintain product shelf life.  
1.2 This specification establishes specifications for hempseed protein products to facilitate commerce, but is not a specification for consumer-facing labels, which are determined by authorities having jurisdiction and individual companies. It does not include devitalized hempseed.  
1.3 This specification applies to hemp food processors, food companies, wholesalers, regulatory bodies, and analytical laboratories.  
1.4 In this specification, the minimum information required in a Certificate of Analysis is described.  
1.5 Where aspects of this specification differ from regional regulatory jurisdictional requirements, the jurisdictional authority’s directive shall take precedence.  
1.6 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.7 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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1.1 This specification establishes an international symbol applicable to all products containing intoxicating cannabinoids at a quantity or concentration sufficient to have a warning deemed necessary by the authority having jurisdiction (AHJ).  
1.2 This specification shall apply to all finished products that are intended for consumer use, which includes topical use, ingestion, inhalation, and any/all other methods of adsorption on or in the body of a human or animal.  
1.3 This specification provides uniformity in identifying potential health and safety hazards associated with exposure to a substance that may cause intoxicating (that is, mind or consciousness altering, or both) effects.  
1.4 This specification seeks to ensure visual clarity and consistency, which results in improvement of recognition and comprehension for the end user.  
1.5 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.  
1.6 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.

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...
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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.

SIGNIFICANCE AND USE
4.1 Use of consistent procedures results in samples that reflect the quality or safety or both of the batch or lot from which samples were taken.  
4.2 Sampling for periodic testing is an important component for maintaining the requisite quality and safety aspect(s), particularly for buyers of raw product or other circumstances in which a further pathogen reduction step is not possible. It may also facilitate identification of product to be assigned to other appropriate usage, storage, or transport options.  
4.3 Consistent test results can enhance confidence of the buyer and credibility of the seller and allow for consistent product sourcing based on category of attribute or product specification.
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1.1 This guide covers recommended steps used in collection of a representative field sample of bulk hempseed intended for human consumption.  
1.2 This guide applies to plant breeders, hempseed producers/farmers, seed cleaners, storage facilities, laboratories, and processors who handle bulk hempseed.  
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.

SIGNIFICANCE AND USE
5.1 As the cannabis and hemp industries expand and their products become more available as consumable products, the following requirements and expectations within the industry become increasingly significant (Practice E2659, Terminology E2708), requiring:  
5.1.1 The safety, reliability, and quality of its products;  
5.1.2 Worker safety;  
5.1.3 Environmental sustainability;  
5.1.4 Regulatory compliance;  
5.1.5 The need for different levels of qualified professionals; and  
5.1.6 Development of qualified training and certificate programs.  
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 a skilled workforce 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, certificate, or certification programs offered. As the cannabis and hemp industries 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.
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1.1 This guide can provide certification bodies, training providers, employers, and certificate issuers, with best-practice guidance for administering their respective programs for transportation and logistics-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 transportation-related professions within the cannabis and hemp industries listed in Table 1.    
1.3 This guide provides recommendations for articulating professional requirements for training and education or earning certificates. Its content does not supersede requirements for training or earning a certificate defined by jurisdictional entities such as government or other regional regulatory bodies.  
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.

SIGNIFICANCE AND USE
5.1 As the cannabis and hemp industries expand and their products become more available as consumable products, the following requirements and expectations within the industry become increasingly significant (Practice E2659, Terminology E2708), requiring:  
5.1.1 The safety, reliability, and quality of its products;  
5.1.2 Worker safety;  
5.1.3 Environmental sustainability;  
5.1.4 Regulatory compliance;  
5.1.5 The need for different levels of qualified professionals; and  
5.1.6 Development of qualified training and certificate programs.  
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 6 (Table 1); 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 a skilled workforce 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 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.
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1.1 This guide can provide certification bodies, training providers, employers, and certificate issuers, with best-practice guidance for administering their respective programs for supporting analytical laboratory-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 analytical laboratory related professions within the cannabis and hemp industries listed in Table 1.    
1.3 This guide provides recommendations for articulating professional requirements for training and education or earning certificates. Its content does not supersede requirements for training or earning a certificate defined by jurisdictional entities such as government or other regional regulatory bodies.  
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.

SIGNIFICANCE AND USE
5.1 As the cannabis and hemp industries expand and their products become more available as consumable products, the following requirements and expectations within the industry become increasingly significant (Practice , Terminology ), requiring:  
5.1.1 The safety, reliability, and quality of its products;  
5.1.2 Worker safety;  
5.1.3 Environmental sustainability;  
5.1.4 Regulatory compliance;  
5.1.5 The need for different levels of qualified professionals; and  
5.1.6 Development of qualified training and certificate programs.  
5.2 The primary objectives of this standard are as follows:  
5.2.1 Provide a general overview of the BoK required for the professions listed in Section 7;  
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 a skilled workforce 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 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
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1.1 This guide can provide certification bodies, training providers, employers, and certificate issuers, with best- practice guidance for administering their respective programs for quality-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 quality related professions within the cannabis and hemp industries listed in Table 1.    
1.3 This guide provides recommendations for articulating professional requirements for training and education or earning certificates. Its content does not supersede requirements for training or earning a certificate defined by jurisdictional entities such as government or other regional regulatory bodies.  
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.

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.
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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.  
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.

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.
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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.

SIGNIFICANCE AND USE
5.1 Effective decision-making in a quality systems-controlled environment comes from an informed understanding of quality issues and associated risks. As such, management should monitor and review the performance of the QMS at pre-planned and regular intervals to ensure the system’s effectiveness and identify opportunities for improvement of the QMS itself. Management should also provide oversight of the QMS by an independent quality practitioner(s) to assure its effectiveness.  
5.2 Moreover, risk-based decision-making encompasses all elements of the QMS and should be at the forefront of each decision. Consumer safety is the top priority, regardless of other considerations.  
5.3 Aspects of risk should be considered relative to intended (or unintended) uses of a product to ensure consumer safety. Management should assign priorities and adequate resources to activities or actions based on assessing the risk, including the probability of harm and the potential severity of that harm. It is essential to engage appropriate parties in evaluating the risk. Such parties may include:  
5.3.1 Consumers;  
5.3.2 Manufacturing personnel;  
5.3.3 Marketing personnel; and  
5.3.4 Other stakeholders, as needed.  
5.4 Implementation of risk management includes assessing the risks, implementing risk management controls commensurate with the level of risk, and evaluating the risk management efforts’ results. Risk management assessment is an iterative process and continues when additional information emerges that changes the potential risk’s nature.  
5.5 Risk management works in conjunction with process understanding to manage and control change and helps drive continuous improvement.
SCOPE
1.1 This guide focuses on the core elements of an effective quality management system (QMS) necessary to optimize consumer and product safety, product quality, and conformance with requirements from industry, governmental agencies, and other authorities having jurisdiction. This guide incorporates basic quality principles, guidelines, and industry best practices necessary to establish a QMS adaptable to all organizations.  
1.2 Laws and regulations from authorities having jurisdiction supersede recommendations within this guide.  
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.

SIGNIFICANCE AND USE
5.1 Information security programs and controls should be implemented by all cannabis businesses to protect information assets, which include information system infrastructure, architecture, analog (paper) and electronic data, files and records.  
5.2 The cannabis industry is in transition from an unregulated industry to a regulated industry, which involves substantial investment. Implementing an information security program helps organizations manage information security threats and protect the organization, employees, customers, vendors and other business partners from unauthorized access, misuse of information, crime, and costly exposure or loss.  
5.3 Cannabis customers and business partners place higher value on keeping information secure and have heightened concerns about information security due to the legal complexities and stigma around the industry.  
5.4 Information systems have multiple access points that present opportunities for vulnerabilities, such as user accounts, removable storage devices, internet connections, malicious malware and other attacks, scams, and poorly guided access controls.  
5.5 This practice intends to help organizations of all types and sizes find an acceptable balance of risks and costs of threat mitigation, recovery and remediation.  
5.6 When planning an information security program, a broad range of input from all departments (or functional areas), levels of staff, and areas of expertise (information technology, legal, compliance, human resources, tax/accounting) is ideal for identifying the highest information security risks to the organization and can make implementation go more smoothly.  
5.7 Information assets must be protected throughout the entire lifecycle (creation, transmission, review, storage, and destruction).  
5.8 Users of This Practice:  
5.8.1 This practice is written for cannabis business operations to be used by:  
5.8.1.1 Business owners and management to develop security controls to prevent, dete...
SCOPE
1.1 This practice covers recommendations for implementing an information security program to protect businesses operating in the regulated cannabis industry. An information security program is part of an overall security program that each business should implement.  
1.2 This practice applies to any legal business entity that handles cannabis products, including cultivation, processing, manufacturing, transportation, warehousing, lab testing, distribution, retail, home delivery, and waste. This practice will include protections for analog (paper) and digital information assets.  
1.3 Actual implementation will vary depending on organizational size and type, information asset types, sensitivity and volume of assets, risk tolerance and resource constraints of the organization, and mandates particular to the organization.  
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.

SIGNIFICANCE AND USE
4.1 This classification standard creates clear definitions for main types of domestic cannabis/hemp plant indoor growing appliances.  
4.2 The purpose of this classification is to standardize the naming of cannabis/hemp plant indoor growing appliance types under the classification.  
4.3 This classification helps to achieve a clarity on the type of configuration available for domestic cannabis/hemp plant indoor growing appliance usage.  
4.4 This classification standard outlines some individual components and aspects of various types of domestic cannabis/hemp plant indoor growing appliances.  
4.5 This classification is not intended to define all terminology, design, mechanical, physical or universal functions and impacts of different technologies attributable to domestic cannabis/hemp plant indoor growing appliances. Such characteristics and category details and nomenclature will be defined in Guide D8374.  
4.6 This standard provides clarity to industry, government, and the public on types of domestic growing appliances for indoor growing cannabis/hemp plants.
SCOPE
1.1 This standard classifies the types of domestic cannabis/hemp plant indoor growing appliances.  
1.2 This classification shall be applicable to growing of cannabis/hemp plants using indoor growing appliances.  
1.3 This classification differentiates between the various types of cannabis/hemp plant indoor growing appliances.  
1.4 The examples for each type of cannabis/hemp plant indoor growing appliance are not intended to be all-inclusive. Examples shown or described in this classification are included only as an aid in the understanding and comprehension of each type under the classification.  
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.  
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.

SIGNIFICANCE AND USE
4.1 Stability testing provides evidence on how the quality and safety of cannabis-based product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. The stability testing will also establish a re-test period for the cannabis product or a shelf-life for the cannabis product under recommended storage conditions. Recommended test conditions are based on ICH Q1A.  
4.2 The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three regions of the European Commission (EC), Japan and the United States. The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV.  
4.3 Requirements of regulatory bodies or governmental departments supersede the recommendations in this guide.
SCOPE
1.1 This guide is applicable to commercial processors and manufacturers engaged in the processing, testing, packaging, labeling, and storage of cannabis products intended for human consumption, including those derived from hemp. Hemp seed and products derived from hemp seed are excluded from the scope of this guide This guide describes the minimum requirements for conducting stability testing of new cannabis products with the purpose of determining appropriate storage conditions and shelf-life.  
1.2 This guide applies to all cannabis-derived products commercially manufactured and distributed for consumer use, regardless of the type of cannabis plant from which they were derived.  
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.

SIGNIFICANCE AND USE
4.1 Laboratories are integral to cannabis/hemp industry operations and consumer safety and satisfaction. Standardized laboratory practices play a key role in establishing and demonstrating product safety, quality, and compliance with the regulations that govern product quality and safety.  
4.2 This guide is intended for use by laboratories as an overview of best practices for operations providing support to the cannabis/hemp industry and its many products. This guide is based on the best practices as articulated in the FOCUS (Foundation of Cannabis Unified Standards) and AHPA (American Herbal Products Association) standards, as well as GMP compliance guidelines.5, 6  
4.3 The contents of this guide reflect the typical requirements imposed by different laboratory regulatory guidelines. It provides recommendations to laboratory operations, GMP, personnel competency, proficiency testing, facility operations, security, sample transfer and receipt, sample handling and disposal, equipment and reagent considerations, reference standards, analytical procedures, data processing and handling, quality assurance, traceability, and accreditation recommendations.  
4.4 This guide is recommended for use by cannabis/hemp laboratory personnel involved in cannabis/hemp laboratory operations.
SCOPE
1.1 This guide provides recommendations for a laboratory licensed or otherwise designated to provide analytical support within the cannabis/hemp industry. Within the scope of this guide, the term cannabis/hemp is inclusive of hemp plants and derived products. This guide presents best laboratory practices, recommended certifications, recommended types of analyses typically required in the cannabis/hemp industry, and recommended quality functions associated with laboratories supporting the cannabis/hemp industry.  
1.2 These recommendations establish a basis for oversight for the analytical testing of cannabis/hemp products. This guide was developed as a complement to existing best practices and, in supporting conformance to current good manufacturing practices (GMP), which are typically required regulatory practices relevant to the cannabis/hemp industries; these recommendations focus on the personnel, security, sample handling and disposal, quality support, data management and reporting activities.  
1.3 This guide generally describes the properties of cannabis/hemp, and cannabis/hemp/cannabis-hemp-derived products to be analyzed.  
1.4 No recommendations found within this guide shall preclude observance of regulations from authorities having regional jurisdiction, which may be more restrictive or have different requirements.  
1.5 This guide applies to all cannabis/hemp containing products commercially manufactured and distributed for consumer use.  
1.6 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.7 This guide does not purport to address all laboratory safety concerns associated with its use. It is the responsibility of the user of this guide to establish appropriate safety and health practices, maintain all safety data sheets (SDS), and document safe practices through work instructions and standard operating procedures (SOPs).  
1.8 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.  
1.9 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.

SIGNIFICANCE AND USE
5.1 According to statistics provided by the NFPA, one of the most common initiating events in a fatal fire is the dropping of a smoking material, such as a pre-roll, onto a bed or a piece of upholstered furniture. Test Methods E1352 and E1353 and NFPA 261 and NFPA 260 have been developed to evaluate the susceptibility of upholstered furniture mock-ups and components to ignition by cigarettes (similarly for pre-rolls). Federal Standard 16 CFR 1632 was promulgated to reduce the likelihood that mattresses and mattress pads would ignite from a lighted smoking material. Research of test methods (NIST 851-2) has found that filter paper substrates can be used to replace the fabric/padding assembly with multiple layers of common filter paper showing a systematic progression in measuring ignition strength. Additionally, smoking materials with high percentages of full-length burns on filter paper substrates (NIST 1436) generate enough heat to keep burning and thus are more likely to ignite soft furnishings than smoking materials with lower percentages of full-length burns.  
5.2 In this test method, the pre-rolls are subjected to a set of laboratory conditions. If different conditions are substituted or the end-use conditions are changed, it may not be possible to use this test method to predict quantitative changes in the fire test response. Therefore, the quantitative results are valid only for the fire test exposure conditions described in this test method. Pre-roll preparation and sampling are very important to ensure minimal impact on results. Preparation shall be made using Practice D8343/D8343M.  
5.3 This test method outlines the moisture content of cannabis herbal material in the pre-roll. Determining the moisture content of cannabis herbal material used will shed more light on the effects of moisture on the probability of a pre-roll to achieve a full-length burn when ignited.  
5.4 The data from this test method can help extrapolate whether a sample set of pre-ro...
SCOPE
1.1 This fire-test-response standard provides a standard measure of the probability of a cannabis/hemp pre-roll positioned on a substrate to generate enough heat to continue burning and thus potentially cause ignition of bedding or upholstered furniture.  
1.2 This test method shall be applicable to pre-roll units that are intended for personal inhalation by means of combustion and contain dried herbal material from any type of a cannabis plant, that is, cannabis/hemp. 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 test method shall be applicable to pre-rolls that burn along the length of a cannabis pre-roll column.  
1.4 This test method shall not be applicable to infused pre-rolls, which are outside the scope of this standard.  
1.5 Pre-roll preparation and sampling shall be made using Practice D8343/D8343M.  
1.6 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.  
1.7 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 Or...

SIGNIFICANCE AND USE
4.1 This classification defines various types of cannabis flower vaporizer devices.  
4.2 This classification shall be applicable to any vaporizer devices intended to be used to facilitate the vaporization of cannabis flower intended for inhalation, regardless of the type of cannabis plant from which the flower was derived. There is no distinction between flower intended for inhalation from a cannabis plant that can be classified as “hemp” and flower that cannot, other than the delta-9-THC content.  
4.3 The purpose of this classification is to standardize the naming of device types under the classification.  
4.4 The classification system breaks the device types into three main categories and three subcategories. These are intended to aid buyers and sellers of these devices in accurately defining the products they are buying or selling. This classification system shall also aid in the understanding of the various types of cannabis flower vaporizing devices that exist in the marketplace by reducing them down to their most common denominator: are they handheld or desk top or other “X”, and are they manual, electronic or distinct.  
4.5 This classification will provide clarity to industry, government, and the public on terminology, and the intended product usage of cannabis flower vaporizers.  
4.6 This classification standard provides a uniform set of usage definitions within the cannabis industry. Included within this classification is a set of figures that outlines some individual components and aspects of various types of cannabis flower vaporizers.  
4.7 This classification is not intended to define all terminology, design, mechanical, physical, or universal functions and impacts of different technologies attributable to cannabis flower vaporizers. Such characteristics and category details and nomenclature will be defined in Guide D8373.  
4.8 Additional specifications, guides and test methods should be created to further international standards in this sp...
SCOPE
1.1 This standard shall classify various types of cannabis/hemp flower vaporizer devices.  
1.2 This classification differentiates between the intended use of each type of cannabis/hemp flower vaporizer devices.  
1.3 This classification shall provide examples of each type of cannabis/hemp flower vaporizer devices. Examples and pictorials shown in the annexes and appendixes or described in this classification are not intended to be all-inclusive and are included only as an aid in understanding and comprehension of the classification system.  
1.4 Vaporizer devices intended for use with materials other than cannabis flower, a dried cannabis flower, or ground dried cannabis flower, or combination thereof, are not in the scope of this classification.  
1.5 This classification shall apply to vaporizer devices used to consume cannabis flower from a cannabis plant regardless of the type of cannabis plant from which it is derived. For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant (cannabis/hemp).  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

SIGNIFICANCE AND USE
4.1 Intended Use—This practice is intended for use by parties who either develop, plan, and conduct internal or external audits, or are interested in the audit process since they are the subject of compliance audits or they mandate such audits to occur.  
4.2 Audits—Audits are conducted by an auditor or audit body that is independent of the entity being audited. Individuals that conduct an assessment of an operation or product that they are directly involved with or have a vested interest in, is technically not an audit. These assessments might be a pre-audit or gap assessment. This practice can be used for these types of activities and the rigor of a true audit may not be as critical.  
4.3 Terms and Concepts—The definition of terms in Section 3 and the perspectives on scale, objectives, and types of audits in Annex A3 provide concepts that help clarify the different roles involved in an audit, the various elements of an audit, and how this practice applies to different situations. This practice is written in terms that accommodate audits for different objectives and sizes.  
4.4 Application—Compliance audits are used to identify gaps between some criteria and the actual operational conditions. Knowledge of gaps are used to assess various risks, guide corrective action, preventive action, root cause analysis, improvement efforts, prevent fines and penalties, or provide stakeholders an objective evaluation of an operation and its potential safety, financial, or other risks. A user of this practice should understand and adapt the audit concepts, process, and responsibilities in this practice to their specific organizational structure and situation.  
4.5 Audit Scale—The scale of an audit can range from an internal audit of a small single operation with fewer than ten employees to an external audit of a large corporation with facilities at multiple international locations. In either case, large or small, the principles in this practice shall be followed to produce...
SCOPE
1.1 Purpose—This practice identifies the minimum requirements for the planning, conduct, and reporting of compliance audits of a cannabis/hemp business. It provides information on terms, procedures, and responsibilities.  
1.2 Intent—The intent is to provide specific instruction needed to develop reliable audit programs and procedures that are used to conduct audits that produce credible, consistent, and objective evidence and findings related to compliance with one or more standards, regulations, policies, best practices, or quality specifications. This practice can be used internally for pre-audit assessments to identify and correct operational gaps.  
1.3 Organization—This practice is organized in the following manner:    
Section  
Scope  
1  
Referenced Documents  
2  
Terminology  
3  
Significance and Use  
4  
Audit Process Overview  
5  
Audit Programs  
6  
Audit Process  
7  
Record Management  
8  
Keywords  
9  
Roles and Responsibilities  
Annex A1  
Auditor Qualifications and Staffing  
Annex A2  
Scale, Objectives, and Perspectives of an Audit  
Annex A3  
Process Diagrams  
Annex A4  
1.4 Nothing in this practice shall preclude observance of federal, state, or local regulations which may be more restrictive or have different requirements.  
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.

SIGNIFICANCE AND USE
4.1 This guide is intended to educate new and experienced users of cannabis flower vaporizers on the various characteristics that can be available in cannabis flower vaporizers.  
4.2 This guide will outline characteristics of cannabis flower vaporizers, which include individual components, design elements, and basic universal functions.  
4.3 This guide will categorize common characteristics using categories based on different technologies and describe in simple terms the details attributable to each category, but is not intended to be all inclusive.  
4.4 The categories outlined in this guide are intended to identify, list, and group the characteristics germane to cannabis flower vaporizers. This guide and the categories created within will be used by subcommittee members of cannabis devices and appliances to further develop standards in the field of cannabis devices.  
4.5 This standard guide will serve to provide clarity to industry, government, consumers and the public on terminology, and universal functions of cannabis flower vaporizers.  
4.6 Reference to a type characteristic in this guide is not intended in any manner to denote endorsement or approval of said type by ASTM International.
SCOPE
1.1 This guide is intended to define characteristics, functions, and technologies commonly present in cannabis/hemp flower vaporizers.  
1.2 This guide shall apply to vaporizers used to consume the flowers of a cannabis plant regardless of the type of cannabis plant from which they where derived. For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant (cannabis/hemp).  
1.3 This guide will provide clarity to the industry, government, consumers and the public to understand what different features and technologies can be present in cannabis flower vaporizers  
1.4 This guide shall be used in conjunction with Classification D8357.  
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.

SIGNIFICANCE AND USE
4.1 This guide is intended to educate new and experienced users of personal cannabis/hemp plant growing appliances on the various characteristics that can be available in personal cannabis/hemp plant growing appliances.  
4.2 This guide will outline characteristics of personal cannabis/hemp plant growing appliances, which includes individual components, design elements, and basic universal functions.  
4.3 This guide will categorize common characteristics using categories based on different technologies and describe in simple terms the details attributable to each category but is not intended to be all inclusive.  
4.4 This guide will serve to provide clarity to industry, government, and the public on terminology, and universal functions of personal cannabis/hemp plant growing appliances.  
4.5 Reference to a type characteristic in this guide is not intended in any manner to denote endorsement or approval of said type by ASTM International.
SCOPE
1.1 This guide is intended to define characteristics, functions and technologies commonly present in personal cannabis/hemp plant growing appliances  
1.2 This guide will provide clarity and understanding to the industry, government, consumers and the general public on different features and technologies that may be present and/or are used in the design and manufacture of personal cannabis/hemp plant growing appliances.  
1.3 This guide shall be used in conjunction with Classification D8390.  
1.4 Units—The values stated in SI units are to be regarded as 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.

SIGNIFICANCE AND USE
4.1 This classification defines various types of cannabis extract vaporizer devices.  
4.2 Extract vaporizer devices can be used to incorporate extracts intended for inhalation from any type of cannabis plant. There is no distinction between those extracts intended for inhalation of a cannabis plant that can be classified as “hemp” and those that cannot, other than the delta-9-THC content. Both forms of extracts are intended to be incorporated into the body by means of direct inhalation of the vapors that result from either combustion or vaporization of the substance. Therefore, the classification system presented in this standard shall be applicable to any vaporizer device intended to be used to facilitate the vaporization of an extract of a cannabis plant intended for inhalation regardless of the type of cannabis plant from which the extract was derived.  
4.3 The purpose of this classification is to standardize the naming of device types under the classification.  
4.4 The classification system breaks the device types into three main categories and two subcategories. These are intended to aid buyers and sellers of these devices in accurately defining the products they are buying or selling. This classification system shall also aid in the understanding of the various types of extract vaporizing devices that exist in the marketplace by reducing them down to their most common denominator: are they handheld or desktop or universal, do they come prefilled or not, and do they connect to a power source by means of threads or a magnet or otherwise.  
4.5 This classification standard provides a uniform set of usage definitions within the cannabis industry. Included within this classification is a set of figures that outlines some individual components and aspects of various types of cannabis extract vaporizers.  
4.6 This classification helps to clarify differentiations between the types of device configurations for consumption usage.  
4.7 This classification will...
SCOPE
1.1 This standard shall classify the various types of cannabis/hemp extract vaporizers.  
1.2 This classification shall differentiate between the intended use of each type of cannabis/hemp extract vaporizers.  
1.3 This classification shall provide examples of each type of cannabis/hemp extract vaporizers. Examples and pictorials shown in the Annexes and Appendixes or described in this classification are not intended to be all-inclusive and are included only as an aid in understanding and comprehension of the classification system.  
1.4 For the purposes of this classification system, the term concentrate and extract are interchangeable in the context of source material being consumed. Concentrate and extract are two different products consumed in the same way  
1.5 This classification shall apply to vaporizers used to incorporate the extracts of a cannabis plant regardless of the type of cannabis plant from which they where derived. For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant (cannabis/hemp).  
1.6 Units—The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.  
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.

SIGNIFICANCE AND USE
4.1 This guide is intended to educate new and experienced users of cannabis extract vaporizers on the various characteristics that can be available in cannabis extract vaporizers.  
4.2 This guide will outline characteristics of cannabis extract vaporizers, which includes individual components, design elements, and basic universal functions.  
4.3 This guide will categorize common characteristics using categories based on different technologies and describe in simple terms the details attributable to each category, but is not intended to be all inclusive.  
4.4 This standard will serve to provide clarity to industry, government, and the public on terminology and universal functions of cannabis extract vaporizers.  
4.5 Reference to a type characteristic in this guide is not intended in any manner to denote endorsement or approval of said type by ASTM International.
SCOPE
1.1 This guide is intended to define characteristics, functions, and technologies commonly present in cannabis/hemp extract vaporizers.  
1.2 This guide shall apply to vaporizers used to incorporate the extracts of a cannabis plant regardless of the type of cannabis plant from which they where derived. For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant (cannabis/hemp).  
1.3 This guide will provide clarity to the industry, government, consumers, and the public as way to understand what different features and technologies are present in cannabis extract vaporizers.  
1.4 This guide shall be used in conjunction with Classification D8376.  
1.5 For the purposes of this guide, the terms concentrate and extract are interchangeable in the context of source material being consumed. Concentrate and extract are two different products consumed in the same way.  
1.6 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

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.

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.

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.

SIGNIFICANCE AND USE
3.1 Access control system devices are installed at strategic locations, such as all exterior entrances, administrative offices, grow rooms, processing rooms, manufacturing rooms, storage areas, transaction areas, loading dock, vaults, and locker room.  
3.2 Access control system software tracks staff by recording access point ingress and egress activities while at the same time enhances the overall safety of the property.  
3.3 An access control system is especially important during an emergency to determine who is on and off the property.  
3.4 Individuals are permitted access after they have been subjected to background screening and issued credentials that allow for real-time monitoring and forensic analysis of employee or vendor on-site movement.  
3.5 All doors should also be secured with electric strike or magnetic locks that remain locked in the event of power loss (default secured).  
3.6 Limited access area door locks, unlocks, and opens through the use of a two-factor authentication consisting of at least two of the following: an access control credential (for example, badge, FOB, wireless device), personal identification number (PIN), or biometric, or combinations thereof with a keyed override system installed.  
3.7 Exterior door locks should be unlocked and opened through the use of a two-factor authentication consisting of at least two of the following: an access control credential (for example, badge, FOB, wireless device), personal identification number (PIN), or biometric, or combinations thereof with a keyed override system installed.  
3.8 Restricted access area, such as a vault and safe are protected by three-factor authentication consisting of at least three of the following: an access control credential (for example, badge, FOB, wireless device), personal identification number (PIN), or biometric, or combinations thereof.  
3.9 Growing, processing, manufacturing, transaction, product, and currency rooms should be protected by a minimum ...
SCOPE
1.1 This guide covers the recommended access control 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 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 prior to use. The recommendations herein are offered as the minimum requirement. All standards are subject to the requirements of the local Authority Having Jurisdiction (AHJ) in any given area.  
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.

SIGNIFICANCE AND USE
3.1 The intrusion detection system (IDS) safeguards various areas considered critical to operations. Intrusion detection devices include but are not limited to, door or window contact alarms that are activated when the device is separated, such as opening; and motion detection technology that uses a passive infrared to survey the area and sounds an audible notification alarm when a person or object moves into the protected space. Also included are glass-break detectors that use an audio sensor to pick up the actual frequency of broken glass. If the glass-break detector “hears” broken glass, an alarm is activated. If any of the devices are triggered when the system is armed, an alert is sent to a 24-h monitoring area for notification.
SCOPE
1.1 This guide covers the recommended intrusion detection system (IDS) 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 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 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.

SIGNIFICANCE AND USE
3.1 A product complaints program is an essential part of the organization’s Quality Management System. The ability to document, investigate, and correct issues related to product complaints provides manufacturers with opportunities for improvement. Putting in place appropriate corrective and preventive actions can lead to increased customer satisfaction, product safety, and increased market share.  
3.2 Requirements of regulatory bodies or governmental departments supersede the recommendations in this guide.
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1.1 This guide is applicable to organizations engaged in the cultivation, processing, testing, packaging and labeling, storage, distribution, or transportation of cannabis products intended for human and animal consumption, including those derived from hemp. This guide describes the minimum requirements for maintaining a product complaint system for finished cannabis products and ensures that all complaints are received, processed, investigated, documented, and appropriate corrective and preventive actions are implemented in a timely manner.  
1.2 This guide applies to all cannabis-derived products commercially manufactured and distributed for consumer use.  
1.3 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.4 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.

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.

SIGNIFICANCE AND USE
3.1 The ability to identify and respond to opportunities before issues become systemic or are a risk to consumer health and safety is vital to maintaining compliance and achieving consumer expectations. The CAPA process is a systematic approach for documenting, identifying, and correcting existing and potential quality issues from various data sources. The CAPA subsystem analyzes and trends data inputs from quality systems and processes to identify if a quality issue is recurring, systemic in nature, or impacts consumer health and safety (see Fig. 1).
FIG. 1 CAPA Process versus CAPA Subsystem
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1.1 This guide applies to all entities that cultivate, process, manufacture, test, and distribute cannabis products.  
1.2 This guide defines corrective action and preventive action (CAPA) and the significance of an effective CAPA process and CAPA subsystem.  
1.3 This guide defines instruction on the establishment of adequate processes and procedures for the identification, analysis, measurement, and correction of quality issues.  
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.