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Testing Heavy & Pesticide Metal, Mycotoxin

crazyandyb
09.03.2019

Content:

  • Testing Heavy & Pesticide Metal, Mycotoxin
  • Contaminants
  • Compliance and Preparedness in Canada’s Cannabis Market
  • Mycotoxins, pesticides and toxic metals in commercial spices and herbs . (z- score below 2) by participation in the proficiency testing rounds organised by the European . Profiling of heavy metal and pesticide residues in medicinal plants. Mycotoxins, pesticides and toxic metals in commercial spices and herbs A risk assessment of heavy metals was performed, indicating daily intake .. toxicity and proved mutagenic effects of chromium(VI) in animal tests. Mycotoxins can cause serious disease or even death. Mycotoxin testing for cannabis products reduces the risk of immunogenic and carcinogenic effects.

    Testing Heavy & Pesticide Metal, Mycotoxin

    The marijuana cultivation facility shall maintain the testing results as part of its business books and records. For more information, please refer to the Final Regulation of the Marijuana Industry. The laboratory shall report this information in the certificate of analysis.

    A cannabis product fails potency testing if the amount or percentage of THC exceeds the labeled concentration of THC, plus or minus 15 percent. A cannabis product fails potency testing if the amount or percentage of CDB exceeds the labeled concentration of CBD, plus or minus 15 percent. A laboratory does not need to analyze for residual solvents and processing chemicals in dried flower, kief, and hashish samples. If the sample fails pesticide testing, the batch fails laboratory testing and may not be released for retail sale.

    If the strains are detected, the batch fails laboratory testing and may not be released for retail sale. The laboratory shall report the results in the certificate of analysis. If the water activity is at or below 0. If the moisture content is at 5. The harvest batch will then need to be retested for all tests required in this chapter. If it fails filth and foreign-material testing, the batch fails laboratory testing. A harvest batch that fails must be destroyed unless it can be remediated.

    Failed manufactured cannabis batches must be destroyed. The testing laboratory shall report to one-hundredth of a percent the concentration in percentage in the certificate of analysis. The Division may elect to require that a Test Batch be submitted to a specific Medical Marijuana Testing Facility for testing to verify compliance, perform investigations, compile data or address a public health and safety concern.

    Medical Marijuana and Medical Marijuana Concentrate. A Medical Marijuana Testing Facility must establish a standard minimum weight of Medical Marijuana and Medical Marijuana Concentrate that must be included in a Test Batch for every type of test that it conducts. A Medical Marijuana Testing Facility must establish a standard number of finished product s it requires to be included in each Test Batch of Medical Marijuana Infused-Product for every type of test that it conducts.

    A Medical Marijuana Testing Facility may not accept a Test Batch or Sample that it knows was not taken in accordance with these rules or any additional Division sampling procedures or was not collected by Division personnel.

    If Medical Marijuana, Medical Marijuana Concentrate or Medical Marijuana Infused-Product failed a contaminant test, then the Medical Marijuana Testing Facility must immediately notify the Medical Marijuana Business that submitted the sample for testing and report the failure in accordance with all Inventory Tracking System procedures.

    If Medical Marijuana, Medical Marijuana Concentrate or Medical Marijuana Infused-Product is found to have a contaminant in levels exceeding those established as permissible under this rule, then it shall be considered to have failed contaminant testing. Notwithstanding the permissible levels established in this rule, the Division reserves the right to determine, upon good cause and reasonable grounds, that a particular Test Batch presents a risk to the public health or safety and therefore shall be considered to have failed a contaminant test.

    These solvents are not approved for use. Due to their possible presence in the solvents approved for use per Rule M , limits have been listed here accordingly. A Medical Marijuana Testing Facility must notify the Division if a Test Batch is found to contain levels of a contaminant not listed within this rule that could be injurious to human health if consumed.

    For potency tests on Medical Marijuana and Medical Marijuana Concentrate, results must be reported by listing a single percentage concentration for each cannabinoid that represents an average of all samples within the Test Batch. For potency tests conducted on Medical Marijuana Infused-Product, results must be reported by listing the total number of milligrams contained within a single Medical Marijuana-Infused Product unit for sale for each cannabinoid and affirming the THC content is homogenous.

    All potency tests conducted on Medical Marijuana must occur on dried and cured Medical Marijuana that is ready for sale. If the THC content of a Medical Marijuana Infused-Product is determined through testing not to be homogenous, then it shall be considered to have failed potency testing.

    The laboratory shall test each sample for microbiological contaminants, mycotoxins, heavy metals and pesticide chemical residue, and for purposes of conducting an active ingredient analysis. During this period of segregation, the producer shall maintain the marijuana batch in a secure, cool and dry location so as to prevent the marijuana from becoming contaminated or losing its efficacy. Under no circumstances shall a producer include marijuana in a marijuana product or sell it to a dispensary facility prior to the time that the laboratory has completed its testing and analysis and provided those results, in writing, to the producer or other designated production facility employees.

    If a laboratory disposes of marijuana, the laboratory shall comply with 21a of the Regulations of Connecticut State Agencies. In addition, the laboratory shall maintain the laboratory test results and make them available in accordance with section 21a of the Regulations of Connecticut State Agencies.

    Each dispensary facility shall have such laboratory results available upon request to qualifying patients, primary caregivers and a physician who has certified a qualifying patient. As part of its initial application, a compassion center shall provide to the Department detailed procedures regarding the testing of medical marijuana, and shall adhere to such procedures in connection with the operation of the compassion center.

    Such procedures shall include a description of how the marijuana will be tested, including:. Test the processed marijuana using a medical marijuana testing laboratory before it is dispensed. Results must be verified and signed by two medical marijuana treatment center employees. Before dispensing, the medical marijuana treatment center must determine that the test results indicate:. The department shall determine by rule which contaminants must be tested for and the maximum levels of each contaminant which are safe for human consumption.

    The Department of Agriculture and Consumer Services shall assist the department in developing the testing requirements for contaminants that are unsafe for human consumption in edibles. The department shall also determine by rule the procedures for the treatment of marijuana that fails to meet the testing requirements of this section, s.

    The department may select a random sample from edibles available for purchase in a dispensing facility which shall be tested by the department to determine that the edible:.

    A medical marijuana treatment center may not require payment from the department for the sample. A medical marijuana treatment center must recall edibles, including all edibles made from the same batch of marijuana, which fail to meet the potency requirements of this section, which are unsafe for human consumption, or for which the labeling of the tetrahydrocannabinol and cannabidiol concentration is inaccurate.

    The medical marijuana treatment center must retain records of all testing and samples of each homogenous batch of marijuana for at least 9 months. A medical marijuana treatment center shall reserve two processed samples from each batch and retain such samples for at least 9 months for the purpose of such audits. A medical marijuana treatment center may use a laboratory that has not been certified by the department under s.

    For more information, please refer to Senate Bill 8A. If cannabis is disposed of, it shall be done in compliance with Section After processing, the CO 2 or solvent based extract must still pass all required tests.

    Unprocessed materials include minimally processed crude cannabis preparations such as inflorescences, accumulated resin glands kief , and compressed resin glands hashish. Processed materials include various solid or liquid infused edible preparations, oils, topical preparations, and water-processed resin glands bubble hash. For purposes of the mycotoxin test, a cannabis sample shall be deemed to have passed if it meets the following standards:. For purposes of the residue solvent test, a cannabis sample shall be below 10 ppm.

    Each dispensary organization shall have that laboratory results available upon request to qualifying patients, designated caregivers and a physician who has certified a qualifying patient. For more information, please refer to the Administrative Code, Title 8: Agriculture and Animals, Chapter 1: Illinois Department of Agriculture, Subchapter V: Licensing and Regulations, Part Organic means certified by an accredited organic certifier in the State of Maine as being in compliance with the United States Department of Agriculture certification requirements applying to organic products.

    Registered dispensaries and registered primary caregivers may not use a pesticide on marijuana plants cultivated for patients unless the pesticide is exempt from federal registration requirements pursuant to 7 U. The department may obtain, possess and perform laboratory testing on marijuana from registered dispensaries. Registered dispensaries are responsible for the cost of laboratory testing of marijuana that is required by these rules.

    The independent testing laboratory shall follow the methodologies, ranges, and parameters which are contained in the scope of the accreditation for testing medical cannabis or products containing medical cannabis. The independent testing laboratory shall require each independent testing laboratory employee to complete and execute an application for employment on a form provided by the Commission. The independent testing laboratory shall establish and follow written procedures for verifying the experience and education of laboratory employees.

    The independent testing laboratory shall submit the registration information for each independent testing laboratory employee within 15 days after the date the independent testing laboratory employee was hired. Upon termination of the association of the registered independent testing laboratory employee with the independent testing laboratory, the independent testing laboratory shall:. The independent testing laboratory shall notify the Commission within 1 business day after the independent testing laboratory obtains notice of any kind that its accreditation has been denied, suspended or revoked.

    No independent testing laboratory may handle, test, or analyze cannabis or cannabis products unless the independent testing laboratory:. Is accredited by an accreditation body or has a provisional registration from the Commission; and. Has established standard operating procedures that provide for adequate chain of custody controls for samples transferred to the independent testing laboratory for testing.

    All sample analyses described in this protocol shall be conducted by an independent laboratory that is either:. Certified, registered, or accredited by an organization approved by the Massachusetts Department of Public Health.

    Further requirements concerning the eligibility and responsibilities of analytical laboratories are provided in CMR In addition to the regulatory qualifications and requirements referenced above, the independent laboratory should have a demonstrated ability to perform the specific analytical methods required and to provide defensible documentation and quality assurance. The optimal cannabinoid profile for medical marijuana has not been definitively determined, and this balance may differ depending on the medical condition being treated AHP, Although many cannabinoids and related compounds are present in the cannabis plant, characterization of the cannabinoid profile should include, at a minimum, the dry-weight percentage of D 9 -tetrahydrocannnabinol D 9 -THC and cannabidiol CBD.

    Because target cannabinoid contents and ratios may vary depending on the desired dosage, medical condition, and other use considerations, minimum profile standards are not mandated. However, the cannabinoid profile must be included in product labeling as an aid to patients and caregivers.

    Analytical procedures for determining cannabinoid profiles are available in AHP Finished medical marijuana products must be tested for the four metals listed in Exhibit 4. A production batch of finished medical marijuana products e. Once a production batch of finished medical marijuana has been determined to meet the limits in Exhibit 4, it must bear the following label:.

    This product has been evaluated for environmental contamination impurities assuming that no more than 10 grams 0. This product has been evaluated for impurities based on oral consumption only. Non-organic pesticides may not be used to cultivate medical marijuana in Massachusetts CMR As discussed in Section 5, all production batches of finished plant material must be tested for residues of prohibited pesticides.

    At a minimum, samples of finished plant material must be tested for the pesticides, including plant growth regulators, listed in Exhibit 5. These pesticides were identified by AHP as commonly used in cannabis cultivation. Exhibit 5 identifies appropriate analytical methods for each of the listed pesticides. Exhibit 5 includes only a small number of the many prohibited non-organic pesticides registered for use in the U. To test medical marijuana for pesticides beyond the minimum list in Exhibit 5, Massachusetts recommends additional testing based on the approach USDA Certifying Agents use to analyze prohibited pesticides in organic food.

    Specifically, pesticide testing should be performed consistent with the following sections of National Organic Program Handbook: A production batch of finished plant material may be dispensed to patients or used to make other medical marijuana products if no individual pesticide or plant growth regulator is detected above 10 ppb. A laboratory that is unable to perform the required testing of pesticide residues at or below the 10 parts per billion ppb criteria may determine compliance by ensuring that any pesticide residues are present at a level less than or equal to 5 percent of the US EPA tolerance for the specific residue.

    In such circumstances, DPH should be notified regarding the specific pesticides to which this method is being applied. Analytical requirements for microbiological contaminants and mycotoxins are listed in Exhibit 6.

    Requirements for total viable aerobic bacteria, total yeast and mold, total coliforms, and biletolerant gram-negative bacteria are given in colony forming unit CFU counts per mass of product sample. The requirement for pathogenic E. Analytical methods for enumerating and identifying specific microbiological contaminants must be consistent with the following United States Pharmacopeia USP chapters:.

    As discussed in Section 4. In particular, a production batch of cannabis oil may be dispensed as a finished medical marijuana product or used to make another medical marijuana product only if:.

    Only solvents listed in Exhibit 7 may be used in the production of cannabis oil. A RMD is required to test only for those solvents used, and it is not required to test for any residual solvents if it can document that no solvents were used in the cannabis oil production process. The upper limits for residual solvents in Exhibit 7 are given as milligrams of residual solvent per kilogram of cannabis oil. A medical cannabis manufacturer must develop and implement a written quality assurance program that assesses the chemical and microbiological composition of medical cannabis.

    Assessment includes a profile of the active ingredients, including shelf life, and the presence of inactive ingredients and contaminants.

    A medical cannabis manufacturer must use these testing results to determine appropriate storage conditions and expiration dates.

    A medical cannabis manufacturer must develop and follow written procedures for sampling medical cannabis that require the manufacturer to:.

    The testing levels are subject to approval by the commissioner;. The sampling and testing results must ensure that batches of medical cannabis meet allowable health risk limits for contaminants;.

    The procedure must include destroying contaminated medical cannabis and determining the source of contamination; and. The quality assurance program must include procedures for performing stability testing of each product type produced to determine product shelf life that addresses:. If shelf-life studies have not been completed before July 1, , a medical cannabis manufacturer may assign a tentative expiration date, based on any available stability information.

    The manufacturer must concurrently conduct stability studies to determine the actual product expiration date. After the manufacturer verifies the tentative expiration date, or determines the appropriate expiration date, the medical cannabis manufacturer must include that expiration date on each batch of medical cannabis. A medical cannabis manufacturer must retain a uniquely labeled reserve sample that represents each batch of medical cannabis and store it under conditions consistent with product labeling.

    The reserve sample must be stored in the same immediate container-closure system in which the medical cannabis is marketed, or in one that has similar characteristics. The reserve sample must consist of at least twice the quantity necessary to perform all the required tests.

    If the commissioner deems that public health may be at risk, the commissioner may require the manufacturer to retest any sample of plant material or medical cannabis. For more information, please refer to Montana Code Annotated — The Division may require the independent testing laboratory to have the testing methodology followed pursuant to this paragraph validated by an independent third-party to ensure that the methodology followed by the laboratory produces scientifically accurate results before the laboratory may use the methodology when conducting testing services.

    The Division may require an independent testing laboratory to have its basic proficiency to execute correctly the analytical testing methodologies used by the laboratory validated and monitored on an ongoing basis by an independent third-party. The Division or an independent third-party authorized by the Division may conduct an inspection of the practices, procedures and programs adopted, followed and maintained pursuant to subsection 3 and inspect all records of the independent testing laboratory that are related to the inspection.

    A sample and related lot or batch fail quality assurance testing for heavy metals if the results exceed the limits provided in the table below.

    The following quality assurance tests are the minimum required tests for each of the following marijuana products, respectively. Licensees and certified labs may elect to do multiple quality assurance tests on the same lot or testing for mycotoxin, pesticides, or heavy metals pursuant to chapter WAC.

    Certified labs must also verify if any unused portion of the sample was destroyed or returned to the licensee after the completion of required testing. Marijuana flower lots or other material lots require the following quality assurance tests:.

    Lots of marijuana flowers or other material that will not be extracted. Intermediate products must meet the following requirements related to quality assurance testing:. Concentrate or extract made with a CO 2 extractor like hash oil. Concentrate or extract made with approved food grade solvent.

    Concentrate or extract nonsolvent such as kief, hash, rosin, or bubble hash. Field of testing is only required if using lots of marijuana flower and other plant material that has not passed QA testing. All marijuana, marijuana-infused products, marijuana concentrates, marijuana mix packaged, and marijuana mix infused sold from a processor to a retailer require the following quality assurance tests:.

    Concentrate or marijuana-infused product for inhalation. Licensees may wholesale and transfer failed lots or batches to be extracted pursuant to subsection 5 of this section. After processing, the extract must pass all quality assurance tests required in this section before it may be sold. At the request of the producer or processor, the WSLCB may authorize a retest to validate a failed test result on a case-by-case basis.

    All costs of the retest will be borne by the producer or the processor requesting the retest. Potency retesting will generally not be authorized. Producers and processors may remediate failed harvests, lots, or batches so long as the remediation method does not impart any toxic or deleterious substance to the usable marijuana, marijuana concentrates, or marijuana-infused product. The entire harvest, lot, or batch the failed sample s were deducted from must be remediated using the same remediation technique.

    No remediated harvest, lots or batches may be sold or transported until the completion and successful passage of quality assurance testing as required in this section. Certified labs may reference samples for mycotoxin, heavy metals, and pesticides testing to other certified labs by subcontracting for those fields of testing. Labs must record all referencing to other labs on a chain-of-custody manifest that includes, but is not limited to, the following information: Lab name, certification number, transfer date, address, contact information, delivery personnel, sample ID numbers, field of testing, receiving personnel.

    Contaminants

    5 Quality Inspection and Test Center for Oilseeds Products, Ministry of Agriculture , limits (MRLs) for pesticides, mycotoxins, and heavy metals. Mérieux NutriSciences provides analytical testing services to ensure the quality including pesticides, mycotoxins, dioxins, veterinary drugs, heavy metals and. Our rigorous medical marijuana testing protocols and best-in-class lab to test mycotoxins and pesticides, and expect to be testing heavy metals in early

    Compliance and Preparedness in Canada’s Cannabis Market



    Comments

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