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Microbiological Safety Testing of Cannabis

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Microbiological Safety Testing of Cannabis September 15, 2018 Department of Licensing and Regulatory Affairs Bureau of Medical Marihuana Regulation Medical Marihuana Facility Licensing [email protected] SENT VIA EMAIL ONLY Re: Public Comment – Testing: MICIL Suggested Amendments to Draft Rule Set, “2017-042 LR” Dear Sir or Madam, MICIL has a several suggested changes to the draft rule set, 2017-042 LR, submitted for Public Comment. Our suggestions, for your consideration: 1) Sampling MICIL recommends a maximum batch size of 10 lbs • MICIL recommends that LARA-BMMR implement a 10 lbs. maximum batch size, rather than the 15 lbs. set forth in §333.248(1)(b) of the draft permanent rules. o NOTE: the current “Safety Compliance Facility Information” document (updated August 29, 2018) lists a 10 lb. maximum batch size, so the draft permanent rules may be an oversight. • Industry medical experts recommend a batch size between 5-6 pounds. • Lower batch sizes may impose an undue financial testing burden on facilities, MICIL recommends a 10 lbs. maximum batch size. • It is important to note, however, that a larger batch size lowers the detection thresholds of certain assays. 1 • As a matter of public health and safety, it is in Michigan’s interest to implement a 10 lb. maximum batch size. 2) Pesticide Remediation MICIL recommends that LARA-BMMR adopt a narrow pesticide remediation protocol • MICIL recommends that LARA-BMMR enact a narrow remediation protocol for pesticide failure. • Under §333.246(3)(b), any sample that fails for pesticides must be destroyed. • MICIL recommends that LARA-BMMR take an approach similar to the State of Oregon. o If only the analytes piperonyl butoxide or pyrethrins are found and the Oregon Department of Agriculture determines that the pesticide products used were listed on the Department’s Guide list for Pesticides and Cannabis and the product was applied in accordance with the label, the Authority or the Commission may permit the producer or grower to remediate the usable marijuana using procedures that would reduce the concentration of pesticides to less than the action level. A batch of usable marijuana that is permitted to be remediated must be re-sampled and re-tested for pesticides.1 3) Mycotoxin Testing MICIL recommends that mycotoxin testing be removed in its entirety • MICIL's unanimous suggestion is to remove aflatoxin in its entirety. • Given its toxicity, only products with a history of aflatoxin contamination should be tested. • There is no readily available evidence to suggest cannabis flower contains any significant levels of aflatoxin, if any. 1 https://www.oregon.gov/oha/PH/DISEASESCONDITIONS/CHRONICDISEASE/MEDICALMARIJUANAPROGRAM /Pages/testing.aspx 2 • Testing for aflatoxin may pose an unnecessary and potentially significant health risk to laboratory staff working in Safety Compliance Facilities. • Below, MICIL has quoted relevant passages from the World Health Organization, the Association of Public Health Laboratories, United States Pharmacopeia, Cannabis Safety Institute and Oregon Health Authority. • Attachments will follow this memo. Attachment 1: Farrer DG. Technical Report: Oregon Health Authority’s process to decide which types of contaminants to test for in cannabis. Oregon Health Authority. 2015 December. p. 2 "Some states have required testing of cannabis for aflatoxins produced by certain Aspergillus species. Oil-rich seeds must be present to produce these toxins on plants. Commercial cannabis does not contain these seeds. As a result, the Technical Expert Work Group recommends against such testing." Attachment 2: Guidance for State Medical Cannabis Testing Programs. Association of Public Health Laboratories. 2016 May. p. 22-23 "There is no readily available evidence to support the contention that cannabis harbors significant levels of mycotoxins. A simple literature search for mycotoxins and cannabis returned only one result: “Examination of fungal growth and aflatoxin production on marihuana” by G.C. Llewellyn and C.E. O’Rear published in Mycopathologia in 1977. That paper examined illicitly grown cannabis seized by law enforcement and found that “[a]ll natural flora cultures tested negative for aflatoxins” and the authors concluded “[m]arihuana appears not to yield large quantities of these mycotoxins.” Given there is no readily available evidence to support the contention that cannabis harbors significant levels of mycotoxins and ongoing advancements in the cannabis industry such as the introduction of requirements to test for microbiological contaminants and improvements in Good Manufacturing Practices (GMP) oversight, it is unlikely that mycotoxins would be identified on flower material." Attachment 3: Microbiological Safety Testing of Cannabis. Cannabis Safety Institute. May 2015. p. 23 3 Aflatoxins are a variety of mycotoxin produced mainly by two species of Aspergillus (A. flavus, and A. parasiticus). Because Aspergillus is ubiquitous, aflatoxins are as well, and many industries have set baseline levels for acceptable amounts of aflatoxin contamination. However, the conditions necessary for the production of significant levels of aflatoxin are not present on Cannabis. Attachment 4:WHO Quality Control Methods for Herbal Materials, Updated edition of Quality control methods for medicinal plant materials, 1998 World Health Organization, Geneva, 2011. p. 85 Whenever testing for aflatoxins is required, this should be done after using a suitable clean-up procedure during which great care should be taken not to expose any personnel or the working or general environment to these dangerous and toxic substances. Thus Member States should adapt their good practices for pharmaceutical control laboratories and good manufacturing practices (GMP) accordingly. Only products that have a history of aflatoxin contamination need to be tested. Attachment 5: 2016 U.S. Pharmacopoeia-National Formulary [USP 40 NF 561]. Volume 1. Rockville, Md: United States Pharmacopeial Convention, Inc; 2015. Articles of botanical origin; p. 7 Caution-Aflatoxins are highly dangerous, and extreme care should be exercised in handling aflatoxin materials... The extent of testing may be a determined using a risk-based approach that considers the likelihood of contamination. • If LARA-BMMR is unable to remove aflatoxin as a required test, MICIL recommends adoption of another state’s action limit. o MICIL suggests that, at a minimum, LARA-BMMR conform with other state standards in regards to the current aflatoxin B1 action limit. o The aflatoxin B1 action limit (<5 PPB) is unnecessarily low and unduly burdensome, given the low occurrence of aflatoxin in cannabis samples. o If LARA-BMMR is unable to remove aflatoxin as a required test, MICIL recommends adoption of another state’s action limit. 4 § Colorado – No mycotoxin tests for any products other than solvent-based concentrates manufactured from flower or trim that failed microbial testing. (The total of aflatoxin B1, aflatoxin B2, aflatoxin G1 and aflatoxin G2 - <20 PPB in solvent-based concentrates that failed microbial products.) § California, Washington, Nevada – All products. (The total of aflatoxin B1, aflatoxin B2, aflatoxin G1 and aflatoxin G2 - <20 PPB.) § Oregon – no mycotoxin test. o MICIL suggests that, if the state is unwilling to remove aflatoxin testing entirely, to remove the individual aflatoxin B1 test in favor of <20 PPB for The total of aflatoxin B1, aflatoxin B2, aflatoxin G1 and aflatoxin. 4) Consumption of food on premises MICIL recommends LARA-BMMR amend §333.231 to allow facility staff the ability to consume food onsite. • MICIL recommends that employee consumption of food in designated rooms, free of chemicals, marihuana & marihuana products, should be permitted by LARA-BMMR. • The current draft of §333.231 would prohibit a standard employee lunch or break room. 5) Moisture Testing • Moisture should not be a pass/fail test, as moisture will dissipate over time. METRC allows adjusting a sample’s weight for moisture loss. Moisture should be recorded and reported, but a sample should not be failed based on moisture. Respectfully submitted, Benjamin J. Rosman, Esq. CEO & Co-Founder, PSI Labs Founder, MICIL 5 MICIL Member Labs <Signature Page Follows> Benjamin J. Rosman – [email protected] (on behalf of PSI Labs) Michael Goldman - [email protected] (on behalf of Iron Labs) Avram Zallen - [email protected] (on behalf of Steadfast Lab) Todd Welch - [email protected] (on behalf of Viridis Group) Jeff Nemeth - [email protected] (on behalf of ACT Labs) Amy Brown – [email protected] (on behalf of ABKO Labs) 6 TECHNICAL REPORT: OREGON HEALTH AUTHORITY’S PROCESS TO DETERMINE WHICH TYPES OF CONTAMINANTS TO TEST FOR IN CANNABIS PRODUCTS, AND LEVELS FOR ACTION Author David G. Farrer, Ph.D. Public Health Toxicologist PUBLIC HEALTH DIVISION Technical Report: Oregon Health Authority’s Process to Determine Which Types of Contaminants to Test for in Cannabis Products, and Levels for Action* Author: David G. Farrer, Ph.D., Public Health Toxicologist Acknowledgments OHA would like to thank the following individuals and organizations for their valuable contributions to the development of cannabis testing Oregon Administrative Rules (OAR 333-7-0010 through 333-7-0100 and OAR 333-7-0400 and 333-7-0410 Exhibit A) and this report: Brian Boling Rose Kachadoorian Laboratory Program Manager Oregon Department of Agriculture Oregon Department of Environmental Quality Jeremy L. Sackett Cascadia Labs, Cannabis Safety Theodore R. Bunch, Jr. Institute, and Oregon Cannabis Pesticide
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