OLCC Streamlining Marijuana License Applications

Temporary Rule Changes

OREGON:  On October 15, 2020, the Commission adopted temporary rules intended to provide relief to the industry and allowing OLCC greater flexibility in the processing of marijuana license applications. The main changes implemented in these temporary rules are:

  • Revising the definition of who needs to be identified as an “applicant” for the license, including raising the threshold from the 10% to 20% ownership.
  • Changing license application requirements, including reducing the amount of information and documentation which was previously required.
  • Modifying when OLCC may request fingerprints for a background check to once per license year, rather than specifically in conjunction with a renewal application.
  • Applicants can change the location of their proposed licensed premises prior to licensure, except for Producers who are prohibited by law from making that type of change until January 2022.
  • Changes to notification and pre-approval requirements when licensees make changes to business structures or financial interests (see below).
  • Simplified paperwork requirements for Producer propagation endorsement and medically designated canopy registration.

In the coming months, the Commission will go through a permanent rulemaking process to finalize the rules, making adjustments based on feedback from the industry and other stakeholders. Anyone wanting to provide comment or input on proposed rules should subscribe to OLCC’s email updates to stay apprised of the most recent activities, including dates and deadlines for public comment.

 

License Application Streamlining

In light of the current licensing backlog, Commission staff have been developing a comprehensive strategy to improve the processing time frame for all licensing actions. The agency believes that implementing the flexibility afforded by this temporary rule package and making internal process adjustments will significantly reduce the time it takes staff to evaluate each license application. The goal is to make the entire licensing process more efficient, timely, and predictable.

There are three main features that characterize the agency’s new streamlined approach to licensing:

  1. Collecting fewer documents as part of the license application.
  2. Relying on the applicant’s attestation that they have provided complete and accurate information.
  3. Giving the applicant the responsibility for knowing and understanding the laws and rules around marijuana licenses, and ensuring that their business will comply with those rules.

As part of the streamlining process, OLCC will ask applicants to complete updated paperwork which aligns with the temporary rule. We recognize that many applicants have already filled out and submitted paperwork for the license application, but the new set of paperwork is straightforward and will significantly reduce the time it takes OLCC staff to evaluate the license application.

Under the streamlined licensing process, a complete application will typically include:

  • An Application Packet for the appropriate license type. These forms have been streamlined to collect the minimum necessary amount of information. They also now include attestations that OLCC staff will rely on to be accurate when determining whether a license can be issued.
  • A Marijuana Applicant Questionnaire, along with an Individual History form for each individual who qualifies as an “applicant” for the license. The Applicant Questionnaire replaces all of the business structure forms that OLCC has historically collected. OLCC license investigators will no longer routinely collect detailed paperwork describing the structure and ownership of the business and analyze that information to determine which individuals and legal entities are “applicants.” Instead, it is the responsibility of the business to completely and accurately identify all “applicants.” The investigation process will not routinely consider other persons with a “financial interest,” although OLCC retains the authority to do so if necessary.
  • A map or sketch of the proposed premises and a floor plan for any indoor areas. New Premises Map Instructions are available that identify what information needs to be included on the map and floor plan. OLCC staff will rely on the applicant’s attestation that the map and floor plan(s) are complete and accurate.
  • A Land Use Compatibility Statement (LUCS). This requirement has not changed. An application must include this form, signed by the local government where the proposed premises is located, showing that the proposed license type is not a prohibited use at the proposed premises.

OLCC staff will continue to evaluate each applicant’s relevant criminal history and their record of compliance when previously licensed before issuing a license.

If an applicant has previously submitted fingerprints for a background check with another marijuana license application, OLCC staff will use the results of that license investigation rather than having the person submit new fingerprints. If an applicant has not previously submitted fingerprints, they will need to do so before the application is assigned to a license investigator.

OLCC will continue to contact applicants to confirm that they are prepared to complete the licensing process within 60 days before assigning them to a license investigator. As part of this contact, OLCC staff will provide instructions for applicants to submit fingerprints.  Do not submit fingerprints until you have received these instructions from OLCC staff.

The licensing timelines established in OAR 845-025-1135 still apply:

  • An applicant must complete the application process within 60 calendar days of being contacted by their license investigator.
    • If an applicant does not complete the process in 60 days and has not previously been in a “hold” status, the OLCC will un-assign the application and place it on hold until the Commission is able to reassign it; the reassignment will NOT take place until after other applications have been processed. Due to the volume of other license actions waiting to be processed, there could be a significant wait time before the OLCC reassigns the application.
    • If an applicant does not complete the process in 60 days and has previously been in a “hold” status, the application will be deemed incomplete and inactivated.

 

WASHINGTON: WSLCB September 16 Board Activity

WASHINGTON: The WSLCB Board met yesterday, September 16, 2020. During the meeting, the following actions were taken:

FDA Approves New Indication For Drug Containing An Active Ingredient Derived From Cannabis To Treat Seizures In Rare Genetic Disease

DISTRICT OF COLUMBIA: Last month, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

CBD is a chemical component of the Cannabis sativa plant. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

TSC is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC usually affects the central nervous system and can result in a combination of symptoms including seizures, developmental delay, and behavioral problems, although the signs and symptoms of the condition, as well as the severity of symptoms, vary widely. TSC affects about 1 in 6,000 people.

Epidiolex’s effectiveness for the treatment of seizures associated with TSC was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex. The study measured the change from baseline in seizure frequency. In the study, patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the treatment period than patients who received placebo (inactive treatment). This effect was seen within eight weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in Epidiolex-treated patients with TSC in the clinical trial were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. Additional side effects for patients with LGS, DS, or TSC include: liver injury, decreased weight, anemia, and increased creatinine.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior, or thoughts of self-harm. Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression, suicidal thoughts or behavior. Patients, caregivers, and families should report behaviors of concern immediately to healthcare providers. Epidiolex also caused liver injury in some patients. Most cases were generally mild, but a risk of rare, but more severe liver injury exists. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

The FDA granted Priority Review designation for this application. The approval of Epidiolex was granted to Greenwich Biosciences Inc., of Carlsbad, California.

Office of Marijuana Policy Unveils New Details On Planned Launch Of Adult Use Marijuana In Maine

Retail sales to the public permitted to begin on or after October 9, 2020.

MAINE: The Office of Marijuana Policy, a part of the Maine Department of Administrative and Financial Services, unveiled plans for the issuance of Maine’s first active licenses for adult use marijuana establishments. The Office intends to issue the first active licenses to recreational cannabis businesses on Tuesday, September 8, 2020. Retail sales of adult use marijuana to consumers 21 years of age or older will be permitted starting on Friday, October 9, 2020.

The issuance of active licenses will continue the Office of Marijuana Policy’s structured rollout of Maine’s nascent adult use industry, which had been indefinitely postponed in April in response to the COVID-19 pandemic.

“The public’s health and safety are at the forefront of every decision we make at the Office of Marijuana Policy,” said OMP Director Erik Gundersen. “While we were poised to launch this new industry earlier this year, we were unwilling to sacrifice the high standards we have set for this program by launching during an emerging public health pandemic and in the absence of a testing facility. With the support of the public health community, municipalities across the state, and the industry we regulate, we have used the last few months to ensure this new industry is introduced to Maine consumers in a manner that is as responsible as possible.”

Active licensure is the culmination of a three-step application process which also includes conditional licensure and local authorization, respectively. An active license is required for adult use establishments to come into possession, process and sell adult use marijuana, including initiating plant transfers from Maine’s existing medical marijuana program.

It is expected adult use licensees will utilize the time between active licensure and Maine’s retail sales launch date to harvest and process marijuana, ensure those products satisfy the mandatory testing requirements, and move product through the supply chain to stock retail store shelves. Additionally, businesses which will conduct retail sales will prepare to implement and support social distancing and other public health guidance at a time when public interest may attract a significant consumer presence to their retail locations.

“Today’s announcement is a major milestone in honoring the will of Maine voters and a significant step toward launching a new industry in the state,” added Gundersen. “Many of the business owners we have spoken with during the application process are ready and eager to commence operations.”

The application process required by the adult use law requires state regulators to review application materials for form and substance, with an eye toward details such as ensuring that all applicants have completed their required state and federal criminal history record checks; that the establishment’s operation, facility, and security plans satisfy the requirements of both the Marijuana Legalization Act and the adult use program rule; and that the designated host municipality has provided the applicant with authorization to conduct business in their community.

OMP expects to issue licenses in each of the four categories of adult use establishments: cultivation, products manufacturing, retail sale, and testing. Information on the specific number of licenses issued and the identities of active licensees will be made available on Tuesday, September 8, 2020.

The Mills Administration created OMP within DAFS in February 2019. The Office is responsible for the oversight of all aspects of legalized marijuana, including Maine’s existing Medical Use of Marijuana Program.

Nevada CCB Launches Investigations Into Three Nevada Dispensaries, Selling Potentially Unsafe Product

NEVADA: The Nevada Cannabis Compliance Board (CCB) has opened investigations into three dispensaries for selling product that twice failed microbial testing.

On March 5, 2020, the Department of Taxation and CCB issued a directive to all dispensary/retail stores to immediately stop selling the product, Cherry OG F3, which failed laboratory testing for yeast and mold, coliforms, Enterobacteriaceae and Aspergillus.

At that time, the CCB instructed dispensary/retail stores to destroy or return the affected product to the cultivator and communicate that they took such action with the State. Despite the CCB’s directive, it appears three dispensaries retained their inventory of Cherry OG and began selling the product again in May.

Approximately 375 grams of the Cherry OG product were sold between May 19, 2020 and June 29, 2020 at the following Retail Stores/Medical Dispensaries:

1. Waveseer of Las Vegas, LLC (Jenny’s Dispensary), 5530 N Decatur Blvd, Las Vegas, NV 89130 (License # 83760475147127946601);

2. Paradise Wellness Center, LLC (Las Vegas ReLeaf), 2244 Paradise Road, Las Vegas, NV 89104 (License # 54283805068313943868); and

3. Desert Aire Wellness, LLC (Sahara Wellness), 420 E Sahara Ave, Las Vegas, NV 89104 (License # 25729455103203031356)

On May 16, 2020, a hold on the product was temporarily lifted due to a CCB error that occurred during an unrelated investigation. However, the CCB’s health and safety advisory remained in effect; and under the directive, dispensaries should not have had the product in their inventory.

The CCB advises those who have purchased the product to avoid consuming it. Consumers should check any Cherry OG products for the source package # 1A404030000076F000006649. The CCB notified the aforementioned dispensaries and initiated investigations which are ongoing. There are no known reports of illness.

Attorney Ben Crump To Announce Civil Lawsuit Against Disney For False Arrest Of Elderly Woman

The great-grandmother was wrongfully arrested for a drug felony at the “Most Magical Place on Earth”

FLORIDA: Nationally renowned civil rights and personal injury attorney Ben Crump will announce a civil lawsuit against The Walt Disney Company on August 5 during a virtual press conference on behalf of Hester Burkhalter.
Burkhalter, a then 69-year-old great-grandmother, was wrongfully arrested and taken into custody at Walt Disney World in Orlando, Florida, for possessing federally legal CBD oil. Hester was using the CBD oil per her doctor’s recommendation to treat her advanced arthritis.
Co-counsels Mark Marderosian and Michele Rayner-Goolsby are also representing Ms. Burkhalter.
WHO: 
Attorney Ben Crump
Attorney Mike Gagliardi
Ms. Hester Burkhalter
WHEN:
August 5, 2020 at 11 a.m ET
WHERE:

Congresswoman Barbara Lee Applauds Passage of Amendment to Protect State, Territory, and Tribal Cannabis Programs

DISTRICT OF COLUMBIA: Congresswoman Barbara Lee (CA-13), co-chair of the Congressional Cannabis Caucus, today applauded the passage of the Blumenauer, McClintock, Holmes Norton, Lee amendment to the Commerce, Justice, and Science Department funding bill. The measure, which would prevent the Department of Justice from using its funds to impede the implementation of cannabis programs in states, territories, and tribes, passed in a 254-163 vote. 

“For far too long, our federal cannabis policies have been rooted in our discriminatory past and have continued inflicting harm on communities of color. As the public’s views toward cannabis have evolved, Congress has a responsibility to ensure that our policies follow suit and move toward restorative justice,” said Congresswoman Barbara Lee. “I’m proud to have worked alongside Reps. Blumenauer, McClintock, and Holmes Norton on this crucial amendment to protect the progress states, tribes, and territories have made toward ending the discriminatory war on drugs.”

“The American people are demanding a change to our outdated cannabis laws and I am glad to see my colleagues heeding their calls,” said Rep. Blumenauer, founder and co-chair of the Congressional Cannabis Caucus. “As we work to ultimately end the senseless prohibition of cannabis and the failed war on drugs, these amendments will help ensure the protection of legal state, territory and tribal cannabis programs.”

Oklahoma Medical Marijuana Authority Says No To Pot Slushy Machines

OKLAHOMA: The OMMA has received multiple inquiries regarding the processing and dispensing of marijuana-infused slushies on-site at medical marijuana dispensaries.  It is the OMMA’s position that marijuana-infused slushies are unlikely to meet requirements set forth in Oklahoma statutes and rules, including, but not limited to:  

  • All products must be in child-resistant packages. Generally, this means the package must be difficult for a 5-year-old to open; opaque; and, if intended for multiple uses (for example, containing multiple servings), capable of being resealed while remaining child-resistant. [See 63 O.S. 427.2 and OAC 310:681-1-4]
  • The medical marijuana production batch that must be tested is the finished product. In this instance, the finished product is the slushy mixture to be dispensed to patients/caregivers, not the syrup. If water, ice, or any other substance is added to the product, additional testing is required to ensure the product is safe for consumption and final-product labeling is accurate.  [See OAC 310:681-1-4 and OAC 310:681, Subchapters 7 and 8]
  •  Dispensaries are not allowed to alter, package, or label products. In addition, dispensaries must refuse to accept or return any medical marijuana products that have not been properly tested, packaged, and labeled by a licensed processor. [See OAC 310:681-1-4 and OAC 310:681-7-1(b)]

Additionally, slushies are considered food products and must be compliant with the Oklahoma State Department of Health food regulations. For more information, please visit the  OSDH Consumer Health Service Food website.

Recap: Nevada Cannabis Compliance Board’s Inaugural Board Meeting

NEVADA: This week the Nevada Cannabis Compliance Board (CCB) held its first board meeting at the Grant Sawyer Building. Led by former Nevada Supreme Court Chief Justice Michael Douglas, who serves as Chair, the CCB moved to approve its core set of regulations, the Nevada Cannabis Compliance Regulations (NCCR 1-14).

Moving forward, the NCCR 1-14 will guide regulation of the cannabis industry in this State. Within those regulations, some highlights include: -An increase to all civil penalty categories (NCCR 4). -A more expansive and comprehensive licensing and approval structure for cannabis companies, owners and employees (NCCR 5). -Enhanced requirements for cannabis testing facilities, including more transparency of results (NCCR 11).

Additionally, the CCB voted to lift the extended review period, now allowing for the processing of transfers of interest. The extended review period was put into place last year, at the recommendation of the special task force, formed by Governor Steve Sisolak, to ensure a more thorough and appropriate vetting process within the cannabis industry.

Lastly, the CCB approved a disciplinary settlement with CWNevada, which held 14 licenses and certificates in this State. The settlement includes the revocation of six licenses, a fine of $1.25 million, remittance of all taxes owed in the amount of $1.5 million, and the forced sale of all remaining licenses to pay back owed employee wages and other financial obligations.

All registered owners of CWNevada will not be allowed to collect any proceeds from the sale and could face additional discipline. The full board meeting can be viewed here. The final NCCR 1-14 can be found here

Rep. Tulsi Gabbard’s Defense Bill Amendment Removes DOD CBD/Hemp Prohibition

DISTRICT OF COLUMBIA: Rep. Tulsi Gabbard (HI-02), a senior member of the House Armed Services Committee, secured an amendment to the annual national defense bill that would ensure that the U.S. Department of Defense may not prohibit the possession, use, or consumption of hemp products — in compliance with applicable Federal, State, and local law — by servicemembers. This would apply to hemp that meets the Agricultural Marketing Act of 1946 definition (amended by the Agricultural Improvement Act of 2018). The Gabbard amendment was included in the final version of the bill which passed on Tuesday, 295-125, and now goes to the Senate for consideration.

“There is great research being done around hemp, resulting in new products coming to market that are proven to help with ailments like insomnia, inflammation, chronic pain, epilepsy, Traumatic Brain Injury, Post-Traumatic Stress and more. Hemp products provide a form of treatment that serves as an alternative option for those who would rather pursue natural remedies rather than prescription drugs. This amendment passed with strong bipartisan support, ensuring our servicemembers have access to the same over-the-counter products that Americans all across the country benefit from today,” said Rep. Tulsi Gabbard.

The 2018 Farm Bill, known as the Agricultural Improvement Act, legalized hemp, defined as cannabis (Cannabis sativa L.) and derivatives of cannabis with extremely low concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC) (no more than 0.3 percent THC on a dry weight basis). Currently, many over-the-counter products are sold that meet these parameters.