Tags Posts tagged with "Lab Testing"

Lab Testing

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Marijuana-stocks-california repbublic

Although it may seem at first glance that there is little to no science behind the testing and determining of strength of various cannabis products, there is a lot that goes into those that the bud-tender tells you. Growers, labs, dispensaries and even individual patients have the option to send their pot-related products to many different testing labs where they can test everything from potency to the presence of pesticides as well as the various terpene levels

However, this process has remained slightly arbitrary throughout time. Still in place today, California has yet to regulate or monitor any of the testing procedures, and although there are some procedures that remain standard, it all depends on the lab.

This is where the state’s Bureau of Medical Cannabis Regulation comes in. They hope to reign upon the industry and propose different models as a set of regulations upon the testing industry. This was announced last month.

According to the statement released, the labs will need to be certified by the International Organization for Standardization. The rules will also apply to technician training, storage techniques and what factors will need to be tested. All of these will also need to be tested twice.

Dr. Robert W. Martin, co-founder and CEO of Oakland’s CW Analytical lab stated that he applauds the state’s efforts, but finds them to be expensive and unnecessary. His opinion is that the state lacks the proper barriers for monitoring quality of the product.

Martin stated “Many levels of detection recommended by the state are at such low levels that many analytical processes will have difficulty providing accurate results…Overall, the regulations, as proposed, will chase many lab operators out of the business as well as growers back to black market pursuits.”

These rules have yet to be fully finalized, and the state is still waiting for public input before they make a hard decision. The opportunity for the public to comment ends June 20th.

Dr. Robert W. Martin is hopeful that organizations across the board will have their opinions reflected on the new rules and the changes that the government wishes to put in place.

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This past Friday, the Bureau of Marijuana Control, the regulatory body overseeing California’s cannabis industry, released a set of proposed regulations for the lab testing market. The regulations are somewhat comprehensive, covering sampling, licensing, pesticide testing, microbiological contaminants, residual solvents, water activity and much more.

Formerly named the Bureau of Medical Cannabis Regulation under the state’s Department of Consumer Affairs, the Bureau of Marijuana Control is tasked with overseeing the development, implementation, and enforcement of the regulations for the state’s cannabis industry. In their statement of reasons for the lab testing regulations, the bureau says they are designed with public health and safety at top of mind. At first glance, much of these laboratory rules seem loosely modeled off of Colorado and Oregon’s already implemented testing regulations.

The regulations lay out requirements for testing cannabis products prior to bringing them to market. That includes testing for residual solvents and processing chemicals, microbiological contaminants, mycotoxins, foreign materials, heavy metals, pesticides, homogeneity as well as potency in quantifying cannabinoids.

The microbiological impurities section lays out some testing requirements designed to prevent food-borne illness. Labs are required to test for E. coli, Salmonella and multiple species of the pathogenic Aspergillus. If a lab detects any of those contaminants, that batch of cannabis or cannabis products would then fail the test and could not be sold to consumers. A lab must report all of that information on a certificate of analysis, according to the text of the regulations.

The proposed regulations stipulate requirements for sampling, including requiring labs to develop sampling plans with standard operating procedures (SOPs) and requiring a lab-approved sampler to follow chain-of-custody protocols. The rules also propose requiring SOPs for analytical methodology. That includes some method development parameters like the list of analytes and applicable matrices. It also says all testing methods need to be validated and labs need to incorporate guidelines from the FDA’s Bacterial Analytical Manual, the U.S. Pharmacopeia and AOAC’s Official Methods of Analysis for Contaminant Testing, or other scientifically valid testing methodology.

Labs will be required to be ISO 17025-accredited in order to perform routine cannabis testing. Laboratories also need to participate in proficiency testing (PT) program “provided by an ISO 17043 accredited proficiency test provider.” If a laboratory fails to participate in the PT program or fails to pass to receive a passing grade, that lab may be subject to disciplinary action against the lab’s license. Labs need to have corrective action plans in place if they fail to get a passing grade for any portion of the PT program.

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Medical marijuana shops and growers are trying to have the state amend regulations in a way that could drastically lower the costs of lab safety testing. Regulations will need a sample to be tested from each 5-pound batch of cannabis prior to any of it being sold. Independent state-certified laboratories run the samples for pesticides, toxins, and microbes, among other contaminants.

In a recent letter to a top state official, the Nevada Dispensary Association stated the 5-pound rule hikes up the cost of marijuana drastically. However, the numbers point out otherwise. Given the prices charged for marijuana and the small amounts sold to each patient, lab testing makes up about 3 percent — or less — of what patients will spend. Prices for lab tests vary, but they normally range between $700 and $1,000 per batch.

“The NDA feels that these fees are prohibitively high and ultimately increase the costs of medical marijuana to the patient, to such an extent that many patients may not be able to afford their doctor-recommended medication for the treatment of a serious condition,” Riana Durrett, executive director of the dispensary group, wrote in a letter to state health official Laura Freed.

Marijuana shops in Clark County are selling a gram of cannabis for $16 to $20 and a quarter-ounce for about $100. That means a marijuana-shop can sell 5 pounds for more than $32,000. If a grower spent $1,000 to have a 5-pound batch approved, the lab tests would tack on only $3 to the cost of a quarter ounce — or less than 50 cents to the cost of a gram.

Durrett’s letter called the 5-pound rule arbitrary and argued the state should instead require testing only on each “propagation batch.” A batch would be defined as “seeds or clones of a unique strain that are propagated during a single day.”

Under that structure, a batch could theoretically be any size, even hundreds of pounds or more.
The state has not yet provided a solution about changing the marijuana testing standard. She said the marijuana shops want a standard that is based on science and hope to start a conversation with scientists and state officials.

Durrett said the state prompted her to talk about potential changes with James Dean Leavitt, president of the Nevada Cannabis Laboratory Association. Leavitt stated that the cost of lab testing is “insignificant” in contrast to the overall costs of cultivating marijuana.

Leavitt stated he would be open to upping the size of a batch if the scientific proof showed it was warranted. However, he said it’s too soon to know and the state should make no alterations until labs have been doing tests long enough to obtain a lot of data. David Goldwater, one of the owners of the Las Vegas-area dispensary Inyo Fine Cannabis, said growers are also pushing to change the 5-pound rule.

“The cultivators are telling us, ‘Hey, this is costing us a fortune and it doesn’t make any sense,’, ” Goldwater said.He added: “Every little bit of regulatory requirement adds cost ultimately to the patient.”
Durrett’s letter said that, while marijuana shops agree testing standards keep patients safe, there’s no proof the 5-pound rule is the safest one. Leavitt said marijuana cultivators’ push to save spending on lab tests which could ironically increase their financial risk. If a sample fails testing, the 5-pound batch from which it came must be terminated.

A company that is doing this is DigiPath Inc. (DIGP). The company works with digital pathology that runs its operation within the marijuana testing industry after the opening of its Las Vegas laboratory this past June Matt Karnes from GreenWave advisors says that marijuana testing is the most attractive subset of the business, which can have many profitable gains if the operation is run efficiently. The company is in a good place to take advantage of a $850 million market opportunity by 2020, with plans to grow within Nevada and into other states that have legalized cannabis.

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