A2LA, Americans for Safe Access Announce Cannabis-Specific Lab Accreditation

By Aaron G. Biros
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The American Association for Laboratory Accreditation (A2LA) and Americans for Safe Access (ASA) announced yesterday a collaboration to develop a cannabis-specific laboratory accreditation program based upon the requirements of ISO/IEC 17025 and ASA’ s Patient Focused Certification (PFC) Program. AccreditationPFC logo for PR under this program will offer the highest level of recognition and provide the most value to the laboratory and users of the products tested, according to a press release published yesterday. ASA is the largest medical cannabis patient advocacy group in the United States. “A2LA is pleased to partner with ASA to offer a cannabis testing laboratory accreditation program to ISO/IEC 17025 as well as the additional laboratory requirements from ASA’s Patient Focused Certification Program,” says Roger Brauninger, biosafety program manager at A2LA.

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Pictured left to right: Kristin Nevedal, Program Manager, PFC at ASA;
Jahan Marcu, Ph.D Chief Scientist, PFC at ASA;
Roger Brauninger, BioSafety Program Manager, A2LA;
Michelle Bradac, Senior Accreditation Officer, A2LA

The program affirms that cannabis laboratories are compliant with state and local regulations and ensures that they adhere to the same standards that are followed by laboratories used and inspected by the Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), and the U.S. Consumer Product Safety Commission (CPSC) among other regulatory bodies. The two non-profit organizations will offer their first joint training course at A2LA’s headquarters in Maryland from July 11th to the 15th. During this course, participants will receive training on PFC’s national standards for the cultivation, manufacture, dispensing, and testing of cannabis and cannabis products, combined with ISO/IEC 17025 training.

The guidelines for cannabis operations that serve as the basis for this accreditation program were issued by the American Herbal Products Association (AHPA) Cannabis Committee, an industry stakeholder panel, and have already been adopted by sixteen states. “We are very excited to see the PFC program join the ISO/IEC 17025 accreditation efforts to help fully establish a robust and reliable cannabis testing foundation,” says Jeffrey Raber, chief executive officer of The Werc Shop, a PFC-certified cannabis testing laboratory. “It is a great testament to ASA’s commitment to quality in their PFC program by partnering with a world-renowned accrediting body to set a new standard for cannabis testing labs.”A2LA logo

According to Kristin Nevedal, program director of PFC, this is an important first in the industry. “This new, comprehensive accreditation program affirms laboratory operations are meeting existing standards and best practices, adhering to the ISO/IEC 17025 criteria, and are compliant with state and local regulations,” says Nevedal. “This program is the first of its kind developed specifically for the cannabis industry, giving confidence to patients as well as regulators that their test results on these products are accurate and consistent.”

“The program will combine the expertise and resources of the country’s largest accreditation body with the scientific rigor and knowledge base of the nation’s largest medical cannabis advocacy group, benefitting the myriad of laboratories tasked with analyzing cannabis products,” says Nevedal. According to Brauninger, a cannabis-specific accreditation program is vital to the industry’s constantly shifting needs. “The ability to now offer a cannabis testing laboratory accreditation program that is tailored to address the unique concerns and issues of the industry will help to add the necessary confidence and trust in the reliability and safety of the cannabis products on the market,” says Brauninger. “Those laboratories that gain accreditation under this program will be demonstrating that they adhere to the most comprehensive and relevant set of criteria by their compliance to both the underlying framework of the internationally recognized ISO/IEC 17025:2005 quality management system standard and the specific guidelines issued by the AHPA Cannabis Committee.” This type of collaboration could represent a milestone in progress toward achieving a higher level of consumer safety in the cannabis industry.

AOCS Highlights Cannabis Lab Standards, Extraction Technology

By Aaron G. Biros
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The American Oil Chemists’ Society (AOCS) held its annual conference in Salt Lake City this week, with a track focused on cannabis testing and technology. Cynthia Ludwig, director of technical services at AOCS and member of the advisory panel to The Emerald Test, hosted the two-day event dedicated to all things extraction technology and analytical testing of cannabis.

Highlights in the discussion surrounding extraction technologies for the production of cannabis concentrates included the diversity of concentrate products, solvent selection for different extraction techniques and the need for cleaning validation in extraction equipment. Jerry King, Ph.D., research professor at the University of Arkansas, began the event with a brief history of cannabis processing, describing the physical morphologies in different types of extraction processes.

J. Michael McCutcheon presents a history of cannabis in medicine
J. Michael McCutcheon presents a history of cannabis in medicine

Michael McCutcheon, research scientist at Eden Labs, laid out a broad comparison of different extraction techniques and solvents in use currently. “Butane is a great solvent; it’s extremely effective at extracting active compounds from cannabis, but it poses considerable health, safety and environmental concerns largely due to its flammability,” says McCutcheon. He noted it is also very difficult to get USP-grade butane solvents so the quality can be lacking. “As a solvent, supercritical carbon dioxide can be better because it is nontoxic, nonflammable, readily available, inexpensive and much safer.” The major benefit of using supercritical carbon dioxide, according to McCutcheon, is its ability for fine-tuning, allowing the extractor to be more selective and produce a wider range of product types. “By changing the temperature or pressure, we can change the density of the solvent and thus the solubility of the many different compounds in cannabis.” He also noted that, supercritical carbon dioxide exerts tremendous pressure, as compared to hydrocarbon solvents, so the extraction equipment needs to be rated to a higher working pressure and is generally more expensive.

John A. Mackay, Ph.D., left at the podium and Jerry King, Ph.D., on the right
John A. Mackay, Ph.D., left at the podium and Jerry King, Ph.D., on the right

John A. Mackay, Ph.D., senior director of strategic technologies at Waters Corporation, believes that cannabis processors using extraction equipment need to implement cleaning SOPs to prevent contamination. “There is currently nothing in the cannabis industry like the FDA CMC draft for the botanical industry,” says Mackay. “If you are giving a child a high-CBD extract and it was produced in equipment that was previously used for another strain that contains other compounds, such as CBG, CBD or even traces of THC extract, there is a high probability that it will still contain these compounds as well as possibly other contaminants unless it was properly cleaned.” Mackay’s discussion highlighted the importance of safety and health for workers throughout the workflow as well as the end consumer.

Jeffrey Raber, Ph.D., chief executive officer of The Werc Shop, examined different testing methodologies for different applications, including potency analyses with liquid chromatography. His presentation was markedly unique in proposing a solution to the currently inconsistent classification system for cannabis strains. “We really do not know what strains cause what physiological responses,” says Raber. “We need a better classification system based on chemical fingerprints, not on baseless names.” Raber suggests using a chemotaxonomic system to identify physiological responses in strains, noting that terpenes could be the key to these responses.

Cynthia Ludwig welcomes attendees to the event.
Cynthia Ludwig welcomes attendees to the event.

Dylan Wilks, chief scientific officer at Orange Photonics, discussed the various needs in sample preparation for a wide range of products. He focused on sample prep and variation for on-site potency analysis, which could give edibles manufacturers crucial quality assurance tools in process control. Susan Audino, Ph.D., chemist and A2LA assessor, echoed Wilks’ concerns over sample collection methods. “Sampling can be the most critical part of the analysis and the sample size needs to be representative of the batch, which is currently a major issue in the cannabis industry,” says Audino. “I believe that the consumer has a right to know that what they are ingesting is safe.” Many seemed to share her sentiment about the current state of the cannabis testing industry. “Inadequate testing is worse than no testing at all and we need to educate the legislators about the importance of consumer safety.”

46 cannabis laboratories participated in The Emerald Test’s latest round of proficiency testing for potency and residual solvents. Cynthia Ludwig sits on the advisory panel to give direction and industry insights, addressing specific needs for cannabis laboratories. Kirsten Blake, director of sales at Emerald Scientific, believes that proficiency testing is the first step in bringing consistency to cannabis analytics. “The goal is to create some level of industry standards for testing,” says Blake. Participants in the program will be given data sets, judged by a consensus mean, so labs can see their score compared to the rest of the cannabis testing industry. Proficiency tests like The Emerald Test give labs the ability to view how consistent their results are compared to the industry’s results overall. According to Ludwig, the results were pleasantly surprising. “The results were better than expected across the board; the vast majority of labs were within the acceptable range,” says Ludwig. The test is anonymous so individual labs can participate freely.

The AOCS cannabis working groups and expert panels are collaborating with Emerald Scientific to provide data analytics reports compliant with ISO 13528. “In the absence of a federal program, we are trying to provide consistency in cannabis testing to protect consumer safety,” says Ludwig. At the AOCS annual meeting, many echoed those concerns of consumer safety, proposing solutions to the current inconsistencies in testing standards.

Philly Tech Week Hosts Conference on Cannabis Investment and Medtech

By Aaron G. Biros
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Philly Tech Week held its first cannabis industry conference this past weekend, hosted by Greenhouse Ventures, a cannabis startup accelerator based in the Northeast. The Innovation in the Cannabis Industry conference brought leaders in cannabis technology, investing and medical research to discuss the changing landscape of the cannabis marketplace in the Northeast.

Tyler Dautrich, co-founder of Greenhouse ventures, welcomes a sold-out crowd.
Tyler Dautrich, co-founder of Greenhouse ventures, welcomes attendees; the event sold out.

Kicking off the event, Tyler Dautrich, co-founder of Greenhouse Ventures, welcomed attendees to the first ever Philadelphia cannabis conference. The initial panel of the day reviewed investment trends and included Scott Greiper, president & founding partner of Viridian Capital Advisors, Marc J. Ross, Esq., founding partner of Sichenzia Ross Friedman Ference LLP, Jim Fitzpatrick, advisory board member at Kodiak Capital Group and John Kagia, director of industry analytics at New Frontier Data Analytics. The panel, moderated by Kevin Provost, co-founder of Greenhouse Ventures, examined various financial trends in the marketplace, roadblocks to raising capital for startups and emerging markets.

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The Investment Trends Panel from left to right: Scott Greiper of Viridian Capital, Jim Fitzpatrick of Kodiak Capital, Marc Ross, Esq., John Kagia of New Frontier and moderated by Kevin Provost.

John Kagia of New Frontier provided useful tools in comparing cultivation models as well as industry projections. “It [the legal cannabis market] has largely been dominated by the West Coast,” said Kagia. “The East Coast is very well poised for success.” Scott Greiper, president of Viridian Capital, discussed his top performing markets. “Biotech is definitely the top performing category and a close second is cultivation and retail –production and sale is at the root of every industry,” said Greiper. “At its core, cannabis is an agricultural commodity.” He went on to list infused products as the third top performing market, noting that edibles account for over half of retail sales.

Future Business Outlook Panel from left to right: Steven Schain of Schain Law Firm, Leslie Bocksor of Electrum Partners and Matt Karnes of Greenwave Advisors.
Future Business Outlook Panel from left to right: Steven Schain of Schain Law Firm, Leslie Bocksor of Electrum Partners and Matt Karnes of Greenwave Advisors.

In looking at emerging markets, Leslie Bocksor, president and founder of Electrum Partners, echoed Scott Greiper’s advice for new businesses to stay grounded in the numbers and operations. “Stay focused on solid, tangible data,” Bocksor said. The two also shared a similar view in opportunities in hemp. “Hemp is a very underserved niche and there are ample opportunities for new businesses,” said Bocksor.

State Senator Daylin Leach (D- Montgomery/Delaware), co-sponsor of the bill for Pennsylvania’s medical cannabis legalization, delivered the keynote address. He lauded the bill, mentioning that patient advocates were instrumental in swaying the legislature. “This is the most important piece of legislation for PA in thirty years,” said Leach. “I have always believed in moving this bill forward and very recently, we passed it with a huge bipartisan majority.” Attendees gave Senator Leach a standing ovation in response to his positive outlook on Pennsylvania’s future with cannabis. “This will be a huge new industry and medical technology is vital to moving it forward.”

State Senator Daylin leach was welcomed with a standing ovation.
State Senator Daylin Leach was welcomed with a standing ovation.

In the afternoon, a panel on medical technology discussed the need for more comprehensive diagnostic tools and crowd-sourced data for treatment with cannabis. David Goldstein, chief executive officer and founder of PotBotics, expressed concerns over bringing consistency to patients. “We need to understand how cannabinoids are affecting patients,” said Goldstein. “We want patients to feel confident in their medication.”

David Goldstein (center) sat on a panel discussing med-tech and how it can help the cannabis industry.
David Goldstein (center) sat on a panel discussing med-tech and how it can help the cannabis industry.

The conference closed with a panel of physicians discussing their clinical experience with recommending cannabis and the gaps in medical research. Among them, Dr. Scott Gottlieb, board-certified anesthesiologist and pain management specialist from Pearl River, New York, discussed some of his experience in recommending cannabis in treating neuropathic pain. The closing panel emphasized the need to educate more physicians and some of the obstacles to physicians recommending cannabis. The conference highlighted the Northeast as a quickly emerging cannabis market ripe with business opportunity.

budgloves

BudGloves Makes Handling Cannabis Safer

By Aaron G. Biros
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budgloves

Kush Bottles, a packaging provider specific to the cannabis industry, recently launched the product BudGloves aimed at reducing the amount of human contact to cannabis products. The company is known for their child-resistant, regulatory compliant packaging.budgloves

The product BudGloves is the first glove of its kind engineered specifically for cannabis. The nitrile gloves do not contain any powder and are designed to prevent any transfer of resin, latex or powder to the cannabis. They are also slightly thicker than most other gloves to avoid getting caught or tearing, extending their life to withstand the typical shift of a trimmer or processor.

Nick Kovacevich, chief executive officer of Kush Bottles, wants to see a standard for preventing human contact with cannabis products to reduce the risk of contamination or loss in quality. Whether it is during cultivation, trimming, inspection, processing, transferring cannabis to instrumentation or even at the point of sale, it is important to minimize human contact to the cannabis.

“In California, we see bud tenders in dispensaries actually reach in a jar and grab cannabis to show the patient without gloves, which is a terrible standard operating procedure,” adds Kovacevich. “I would want all bud tenders to handle cannabis with gloves on.”rsz_budgloves2

Particularly when handling food-grade products, most health code regulations require the use of gloves like these. According to Kovacevich, oils and extracts can be at a greater risk of contamination. “It is imperative that concentrates and extracts, especially those with activated THC, are handled with gloves to prevent any outside materials or contaminants from sticking to them,” says Kovacevich. The gloves are manufactured to meet stringent quality standards. To promote safety and quality of cannabis, reducing human contact with the product should be an important part of any company’s employee manual.

Pennsylvania to Legalize Medical Cannabis

By Aaron G. Biros
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HARRISBURG, PAOn Wednesday, the Pennsylvania Legislature approved a bill to legalize medical cannabis. Pennsylvania will be the 24th state to legalize cannabis in the United States. The House voted 149-46, passing bill SB3 and sending it to Governor Tom Wolf, who signed the bill into law on Sunday.

The bill, with a list of seventeen qualifying conditions, will allow for certifying physicians by the Pennsylvania Department of Health and licensing growers and dispensaries. The bill also requires standards for traceability in regulatory oversight, establishing criminal penalties for diversion or falsification of identification cards issued to caregivers and patients.

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House Majority Leader Rep. Dave Reed

House Majority Leader, Rep. Dave Reed (R-Indiana), believes the bill allows for robust regulatory oversight. “[…] I am confident Senate Bill 3 provides all the necessary protections to prevent the abuse of medical cannabis, including its unavailability in leaf form,” says Reed. “This new health care program will be closely monitored and if there are found to be weaknesses in the law down the road, we can certainly make any necessary revisions.”

The measure’s prohibiting the distribution of cannabis in dry flower form follows New York’s policy of only allowing patients to use it in forms other than smoking, such as vaporizing or consuming orally in capsules.

PAMCS

Tom Santanna, director of government relations at the Pennsylvania Medical Cannabis Society, is confident the PA Department of Health is the right organization to regulate medical cannabis. “An important part of the regulatory process includes providing for the safety of cannabis via laboratory testing, and it is our feeling that the PA Department of Health is the correct agency for that task,” says Santanna. “The legislation gives the Department of Health the authority to create standards for safety and it is our goal as an organization to work with them to make sure the proper safeguards are in place.”

State Senator Daylin Leach introduced the bill
State Senator Daylin Leach introduced the bill.

The passing of this legislation will undoubtedly encourage more doctors to consider recommending cannabis as a treatment option in Pennsylvania. Dr. David Casarett, professor of medicine at the Perelman School of Medicine, University of Pennsylvania, believes this could help a number of his patients. “When it becomes legal in Pennsylvania, I will certainly discuss it as an option for some of my patients,” says Casarett. “If it is legal, then at least I will know my patients are getting it from a safe and reliable source, without supporting the illegal drug trade and organized crime.”

State Senator Daylin Leach (D- Montgomery/Delaware) introduced the bill and has introduced medical cannabis legislation in every session since 2009. Steve Hoenstine, spokesperson for State Senator Leach, believes the measure will have the most intensive protections for safety in the country. “Our goal was to create a system that helps as many patients as possible, as soon as possible and as safely as possible,” says Hoenstine. “The seed-to-sale tracking system and the bill’s other protections do just that.” State Senator Leach will deliver the keynote speech at the Innovation in the Cannabis Industry; Technology, Medical & Investment Conference in Philadelphia on April 30.

It is expected to take up to two years to begin the implementation of regulations and allow retailers to open their doors to patients.

DEA To Consider Rescheduling Cannabis, Could Mean Policy Shift

By Aaron G. Biros
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In a letter sent to lawmakers last week, the Drug Enforcement Agency (DEA) announced plans to make a decision on rescheduling cannabis by mid-2016. The announcement could represent the culmination of a shift in the federal government’s attitude toward cannabis legalization.Dea_color_logo

Currently, cannabis is a Schedule I narcotic, meaning the government views it as lacking medical benefits and have a high potential for abuse. The rescheduling of cannabis has the potential to open the floodgates for research, including much needed clinical trials.

Derek Peterson, chief executive officer at Terra Tech, a cannabis-focused agriculture company, believes this bodes well for the growth potential of the cannabis industry. “From the perspective of quality and safety standards, I find it unlikely that rescheduling it would negatively impact the degree to which cannabis is examined,” says Peterson. “It’s unnecessarily high position on the DEA drug schedule does nothing but limit the industry’s potential for growth, stall any meaningful pharmaceutical testing and increase law enforcement’s ability to prosecute non-violent drug offenders,” adds Peterson.

The rescheduling could also potentially allow for the prescribing of cannabis for patients. Stephen Goldner, founder of Pinnacle Labs and president of Regulatory Affairs Associates, is hopeful this will lead to a greater shift in public attitude towards cannabis. “The DEA’s announcement is a clear message to all States and possibly even to United Nations policy makers: even the DEA is willing to reconsider cannabis,” says Goldner. “Since the DEA is reconsidering cannabis, state politicians and local police departments can also be flexible and move away from prohibition, towards the regulation of cannabis.”

The rescheduling of cannabis could have a tremendous impact on the growth of the cannabis industry, including more clinical trials, medical research and physician participation. It could also open the door for more federal agency involvement, as the Schedule I status inhibits any EPA research on cannabis pesticide use or FDA guidance on food and drug good manufacturing practices. When reached for comment, the FDA’s press office said they could not speculate on any involvement in the matter.

good to know kit

Colorado Distributes Consumer Education ‘Good To Know’ Kits

By Aaron G. Biros
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good to know kit

The Colorado Department of Public Health and Environment (CDPHE) launched the Good to Know program in January of 2015, aimed at educating the public on consuming cannabis responsibly. The CDPHE developed a free kit for retailers that will be distributed this week, hoping to reinforce safe and responsible experiences with cannabis at the consumer level. Intended specifically for recreational cannabis retailers, the educational materials will be distributed at the point of sale.

good to know kit
The Good to Know kit for retailers

According to the CDPHE, last year between April and August, Colorado saw a 28 percent increase in retail cannabis sales. In anticipation of a period of high demand this summer, the ‘Good to Know’ retailer kits are being distributed this week. According to Ali Maffey, CDPHE policy and communication unit supervisor, the state is mailing 100 kits to additional retailers ahead of cannabis-related events, such as April 20th, which are expected to bring an influx of tourists.

The takeaway information cards in the kits display frequently asked questions regarding edibles and secondhand smoke, as well as advice for appropriate legal usage of cannabis. “The educational materials can help guide bud tenders through a conversation with a consumer to prepare them for the effects of cannabis, dosage considerations, using caution with edibles, driving impairment and the risks of second hand smoke,” says Maffey. “Voters passed the legalization of cannabis, and as the state health department our role is to educate on the safe and responsible use of cannabis, while safeguarding public health.”

The continued efforts by the state for consumer education could highlight an important push for safety. “We have been talking with other states about what works in our messaging and they are all looking at public education campaigns as well,” says Maffey. In this respect, Colorado is leading the country in educating consumers on safe, responsible and legal cannabis use.

Nic Easley: How Far Have We Come?

By Cannabis Industry Journal Staff
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Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), delivered the keynote address at the first annual Cannabis Labs Conference, co-located with Pittcon. Easley begins with a discussion of the 2014 milestone where Colorado and Washington legalized recreational cannabis, opening the floodgates for a diverse range of products and business opportunities in quality and safety testing. With members of his team sitting on the Colorado Department of Agriculture’s Pesticide working group, they are working with industry leaders and regulators to comprehensively write the standards. “The industry gets regulated in 2014 in Colorado with a total of $2.7 billion in sales in the first year of the industry’s history,” says Easley. “We have this giant influx of business, but without process validation, good agricultural practices and proper SOPs, each state is left to fend for themselves to write regulations.”

keynotecannabislabs

Nic Easley Delivers Keynote at Cannabis Labs Conference

By Cannabis Industry Journal Staff
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keynotecannabislabs

Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), delivered the keynote address at the first annual Cannabis Labs Conference, co-located with Pittcon. Easley set the tone of the conference early on by identifying safety and quality concerns in the current cannabis marketplace. “We can choose to do business as usual or we can create a new model with outside industry expertise to help guide this industry forward responsibly,” says Easley. Noting the existing comprehensive standards in food and agriculture, Easley emphasized the value of the Cannabis Labs Conference in bringing that expertise to the cannabis space. “We have the guidance and expertise in this room alone to help move the cannabis industry forward out of the closet and into the sunlight,” adds Easley.

 

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California Legislature Votes to Slow Local Bans on Cannabis Cultivation

By Aaron G. Biros
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SACRAMENTO, CA- Lawmakers in California voted to pass Assembly Bill 21 this morning, a bill aimed at slowing local municipalities from placing bans on cultivating cannabis. Earlier this week, the California Senate passed the bill in an overwhelming 35 to 5 vote, sending it to the Assembly.

The bill, AB 21, won unanimously in a 65 to 0 vote this morning, according to a lobbyist on behalf of CalCann Holdings. The bill now heads to Governor Brown’s desk to sign it before it becomes a law. The governor has twelve days to sign it into law because of an urgency clause. 

“Over the past several months, local governments throughout the state have been banning marijuana cultivation and dispensaries right and left,” says Aaron Herzberg, attorney and partner at CalCann Holdings. CalCann Holdings is a California-based medical marijuana holding company building a portfolio of licensed MMJ businesses and properties.

“Assuming Governor Brown chooses to sign this bill into law, cities will have the time to take a more reasonable approach to this issue and, ideally, allow licensed marijuana to be cultivated and distributed throughout the state,” adds Herzberg. “This is a vitally important piece of legislation that fixes a serious drafting error, and the sooner it can be signed into law, the better.”

The bill fixes an important mistake in the regulations that previously allowed the state to license growers operating in municipalities without written laws in place yet by March. Because of that deadline, cities were rushing to ban growers and dispensaries before they lost autonomy to regulate them. Governor Brown is expected to sign the bill into law, which would curb municipalities from shutting down cannabis businesses.