Aloha Alliance!

The August meeting of the Act 230 Legislative Working Group tasked with improving the laws and regulations overseeing Hawai‘i’s medical cannabis industry came to a close today, on August 23, 2017. In the audience were almost a dozen members of the Hawai‘i Dispensary Alliance, representing every aspect of the industry. The Committee heard from O‘ahu dispensary Cure Oahu about their progress and plans. The Department of Health gave a brief update on the status of the registry system, the dispensary system, and laboratory certification. The meeting was dominated with questions and answers expressing the Working Group and public’s growing concern about the increasing delays in the laboratory certification process for extractions and other product derivatives. The meeting also included the proposal of new interim rules language to allow dispensaries to sell specific types of vaporizer cartridges.

The University of Hawai‘i Public Policy Center administers the operations of the working group and posts all documents generated by and for the committee to their website. If you would like to sign up for the working group’s email list, email your request to Act230wg@gmail.com.

This article will cover everything that happened in the meeting today in a detailed narrative, much like a Q&A, organized according to the meeting agenda. These notes are not verbatim, but as close as our notes will allow. This meeting was broadcast on Olelo, Channel 49, starting at 2:00 pm. Additional airings of the broadcast will be on Olelo 49 at the following times:

  • 6:00 pm on September 6, 2017
  • 10:00 pm on September 10, 2017
  • 9:30 am on September 11, 2017
  • 1:30 pm on September 12, 2017

If you have any questions about the meeting, or about how to get involved in the industry, email the Hawai‘i Dispensary Alliance at info@hawaiidispensaryalliance.org or find us on Facebook.

Panel Members Present

The meeting began with a brief introduction of all of the committee members. The list of participants at today’s meeting and their affiliation include:

Present Panel Members

  • Representative Della Au Belatti, Co-Chair
  • Senator Rosalyn Baker, Co-Chair
  • Senator Will Espero
  • Representative Joy San Buenaventura
  • Carl Bergquist, Drug Policy Forum
  • Wendy Gibson, Medical Cannabis Coalition of Hawai‘i
  • Michael Takano, Pono Life Sciences, Maui CountyDispensary
  • Richard Ha, Lau Ola, Hawai‘i County Dispensary
  • Karen Kahikina, Department of Transportation, Airports Division
  • Rob Lee – Department of Transportation, Airports Division
  • John Paul Bingham – CTAHR
  • Thomas Wills – UH Cancer Center
  • Ally Park – Clinical Laboratories/AEOS Labs
  • Greg Yim – Physician

The Working Group is administered by Dr. Susan Chandler and the University of Hawai‘i Public Policy Center, with assistance from Center Director Collin Moore, Dr. Michelle Ibanez, and Joy Agner, policy assistant. A guest moderator, Jose Barzola from the Public Policy Center, managed the August meeting in place of Dr. Chandler who is on sabbatical.

A review of the minutes from the previous meeting was postponed to the end of the meeting.

Dispensary Presentation: Cure Oahu

The meeting shifted to a presentation from O‘ahu dispensary Cure Oahu (Applicant TCG Retro Market 1), one of three O‘ahu dispensaries. Each of the dispensaries has presented to the Committee about their progress, their contact with current patients, and any obstacles of general application that they are facing.

Cure Oahu was represented by Chief Compliance Officer Keith Kamita, kkamita@cureoahu.com.

Presentation and Notes:

Mission Statement

Improving the qualify of life of qualified Hawai‘i patients, and empowering their health decision in a safe, supportive, and knowledge-based setting.

Goals

  • Quality products
  • Best-in-class customer services
  • A convenient, relaxed, and comfortable dispensary environment
  • Done through best practices with no contaminants

Products

  • Flower
  • Pills
  • Tinctures
  • Lozenges
  • Ointments

Status

We have completed our first production facility.

We have completed our first retail dispensary facility.

We are working on selecting sights for our second production facility and second dispensary location.

We have been working on community education. We have answered 21 requests by giving 15 presentations, covering 1,400 people with different needs, chiefly physicians and law enforcement. We talked about what physicians can do under the law and the laws for law enforcement to enforce.

Challenges

  • Banking – We need safe and locally viable banking for industry.
  • State and local regulatory requirements – We need improved coordination between state and county agencies—for example, sanitation, environment, and food quality need coordination.
  • Laboratory testing – Standards and protections continue to be in development.
  • Tracking system glitches – We are working through software integration issues and glitches. We have both Biotrack and a secondary tracking system.
  • Federal laws and policies – It’s a moving target, the federal government. It depends on Trump and Sessions. Lots of other issues, too, like rescheduling, who will be involved, and how will it be handled.

Keith Kamita: That was real quick. We know we are the last dispensary to present, so I wanted to leave a lot of time for questions.

Q: Rep. Joy San Buenaventura – When will you begin selling?

A. Kamita – We started growing in September. We will probably open in December.

Q. Sen. Rosalyn Baker – Are you looking to market other products?

A. Kamita – Yes, it depends on the laboratory, as we see it coming along. We don’t want to make other products now and sit on them.

Q. Carl Bergquist, Drug Policy Forum – You mentioned community outreach, could you please talk a little more about that?

A. Kamita – We’ve talked to law enforcement and medical providers. When we talk to medical groups we talk about both sides, the opioid epidemic and potential alternatives. Cannabis always come up, so I show how to register and how patients are handled by DOH. I stress that it is not a prescription, just take the patient through the certification process.

For law enforcement, we are telling them the law, the requirements, the updates on what patients can have, how do you verify their cards—what Scottina Ruiz was saying. We did some of these right away, now we are talking to others.

Q. Rep. Della Au Belatti – You have two tracking platforms. In the Reciprocity Subcommittee we had discussions that dispensaries could help with regulation and identification of out of state patients. Would that help? Can you do that?

A. Kamita – Yes we can, same way as BioTrack would do it. Just grab the data from BioTrack. There are still some issues. I was talking to others about reciprocity. We have to figure out a way for doctors and patients to preregister with DOH prior to arriving, or if you make a dispensary do it, there may be some issues. But there are a lot of different possible solutions. It will take legislative change.

A. Rep. Belatti – I will differ on that point, in that we can create a solution that allows DOH and the dispensaries to cooperate to streamline the process under the current administrative rules. But I don’t know if you can drive it through BioTrack?

Q. Sen. Baker – Regarding banking, can we look at other solutions? No one has a solution. Everyone is nervous.

A. Kamita – We are working through HEALTH for banking. They are exploring a local solution, but we don’t want to say yet.

Q. Sen. Baker – A concern is that DOTAX facilities are not as secure on other islands.

A. Kamita – We need to reach a point where we can take credit and debit cards.

Q. Sen. Baker – Do you mind talking about your background?

A. Kamita – I was chief of the State Narcotics Enforcement Division. I ran prosecutions for 15 years. That is why I was hired, to keep things strict. I’m the moral compass.

Q. Greg Yim, Physician – What is your thoughts on Schedule I and how it will change?

A. Kamita – If it is not Schedule I, you have to figure out the FDA’s role. Anything Schedule II through V requires FDA oversight. Otherwise I agree that it should not be schedule I. Maybe something like II B.

Q. Sen. Baker – That could slow down the process of selling, because products will have to go through the FDA?

A. Kamita – We know some cannabis products have been going through the process for 10 years and they are still not through.

Q. Sen. Baker – What can you do with hemp? Can you order products through the mail or oil from Belgium?

A. Kamita – There is an issue with hemp, how you release it and sell it. It has to come out of Belgium made with only seeds and the stalk. No flower, no leaves. If it says 100 percent hemp, there is no law against it in Hawai‘i. Anything over 0 percent THC is still marijuana. So if you sell  any of that it is still marijuana.

Q. Rep. Belatti – Let’s talk about the federal law passing and its impact on the dispensaries. It is embedded in the law that if there is a change in scheduling, the governing law is the state law. Knowing they have separate jurisdictions, it is not conclusive that cannabis would be subject to FDA requirements. We want to leave it an open legal question. We have as a state have occupied a space. If we can maintain the regulatory standards, then we argue it will be governed by us. There could be arguments on the other side, but we want to purposefully protect the state system in the law.

A. Kamita – Following the Cole Memorandum as closely and specifically as possible, then, the Feds will leave us alone as in other states if we say we are really going to stick to our regulations. As a compliance person, I like that, I know where that line is.

Q. Wendy Gibson, Medical Cannabis Coalition of Hawaii – We want it out of the Controlled Substances Act. Thoughts?

A. Kamita – That will be difficult. If the Feds remove it, Hawai‘i has 30 days to argue or follow suit.

Q. Rep. San Buenaventura – I went to a Boston meeting and CSG West, were I heard Arizona Rep. Hec gave a federalism lecture on banking laws. He said he has the votes in the House and the Senate to pass banking reform for the industry. They are being blocked only by the Chair of the Finance Committee.

Iris Ikeda at DCCA has guidelines. The Colorado Credit Union Association says they are talking with Hawai‘i credit unions. Washington banks say that it comes at a steep surcharge, $8,000 a month in addition to regular fees. There is light at the end of the tunnel. We just need a bank or credit union.

A. Kamita – If you look at Canada, there are maybe some solutions, too.

Q. Ally Park, Clinical Laboratories/AEOS Labs – What about Colorado? They are reclassifying all recreational as medical to comply with the Cole Memorandum.

Kamita – A lot of times with the Cole Memo, they ask how you as retailer can sell and guarantee where the product is going. You have to make sure it is not released for illicit purposes and where the money is coming from. It is a good step and they are looking at it.

Q. Bergquist – Patient demand and supply—how are you assessing supply and demand? You mentioned a possible second location. Where are you looking? Westside?

Kamita – We are always looking. We are taking our time to learn from others’ experiences. We are taking time to build a stock of products. We want to open ready to sell and sustain. As far as a second location, we are watching our locations. We don’t want to be right next to others. We are looking where the public is and where to best service them.

DOH Monthly Update

After the Dispensary Presentation, DOH gave a monthly update on the progress of its Registry and Dispensary departments.

Patient Registry Program

Danette Wong Tomiyasu:

Please check the DOH website –  Patient counts are updated monthly.

Keith Ridley is out of town, I’m filling in for him. I don’t have operational expertise so I brought the team from DOH: Tammy Whitney and Peter Whiticar. Both oversee the Registry Program. Scottina Ruis has resigned. She contributed tremendously, and we are sad to see her go.

In your packets there is a newsletter, the Medical Cannabis Update. It speaks to Scotty’s accomplishments. She successfully led the transition from DPS to DOH. She also turned a paper based system into a modern online system. She greatly influenced the efficiency of the program. When it started, turnaround was four to six weeks for a new patient card. Now it is four days. It is a tremendous loss and we wish her well.

Peggy Leong is also with us. She is the supervisor and overseas the Dispensary Program.

We have seen no perceptible spike in patient card applications after the two dispensaries opened. But we are standing by and waiting for more openings to occur.

Dispensary Licensing Program

Danette Wong Tomiyasu for Keith Ridley (Absent), Director of the Office Healthcare Assurance:

I’ve distributed what I’ll be providing and some attachments. AVAILABLE HERE IN FULL.

Or here individually:

  1. DOH Report
  2. Dispensary Certification Progress
  3. Laboratory Certification Progress

Dispensary Progress

  • Maui Grown Therapies and Aloha Green opened on August 8 and 9, respectively.
  • Maui Grown Therapies took a soft-opening approach.
  • Aloha Green opened on August 9 for all patients, first come, first served.
  • In total they have served about 3,000 patients, who purchased  about 4,000 products, or about about 12,000 grams (around 26 pounds).
  • Cure Oahu received its notice to cultivate. We will conduct the second inspection of their dispensary retail location in September.
  • Manoa Botanicals is scheduled for a pre-retail inspection in September. Then, after lab testing, we will conduct the opening inspection on request.
  • Inspections continue by request and by surprise for the other dispensaries.
  • Ongoing meetings with the dispensaries continue. The next meeting is to discuss Interim Administrative Rules changes and operational issues on August 25.

Laboratory Update

Q. Sen. Baker – Before you go on, it is important that we try to understand and that we figure out what it is going to take to get the lab to test manufactured products. How ironic is it that we can sell flower, but we don’t like smoking, and we can’t sell anything else.

A. Dr. A. Christian Whelen, DOH State Laboratories Division – The provisional certification we issued was for flower only. They have made progress on other components, but of the remaining outlying contaminates pesticides are the one they need to complete. This is very important since they are concentrating product. The labs are getting close. We hope to provide quick turnarounds on the reviews.

Q. Sen. Baker – Will they be the only lab certified this century?

A. Dr. Whelen – Will have to ask other labs.

Q. Sen. Baker – You are in charge. We need a thorough understanding. The dispensaries are online, and patients have needs beyond the flower.

A. Dr. Whelen – In the summary document in front of you, you have details about their progress and future. We are verifying the work they are doing, but it is incumbent on the lab to submit the data packages to us. We touch base several times a week, asking for progress, anticipations, and problems. We agree to review protocols ahead of time so we don’t waste data collection on things that don’t meet expectations. We are trying to help move their standards forward.

Q. Sen. Baker – Have you given them a set of requirements so the labs know what they need to meet—methods, protocols, goals? I don’t want DOH to be the hold up.

A. Dr. Whelen – We communicate with the labs frequently. If we are not providing them the information they need, I am not aware of it.

Q. Sen. Baker – So when do you anticipate another lab and a lab that can test manufactured products will be certified?

A. Dr. Whelen – That is a crystal ball question. We can’t predict when they will submit data packages to me. I can ensure that we turn around data packages very quickly. It is our top priority.

Q. Sen. Espero – Do all of the labs know what must be done in order to be certified in terms of testing manufactured product?

A. Dr. Whelen – I’m open to any questions they have to me. To my knowledge, there are no outstanding questions about the rules.

Q. Sen. Espero – So if I wanted as a lab to do manufactured products, could you give me a requirements checklist? Is that a handout, steps 1-20, and you’re certified?

A. Dr. Whelen – The requirements are rules. There is more than one way that a laboratory can meet the rules.

Q. Sen. Espero – Do you have that in a simplified handout form? Is the State making it easier and simpler so it can be complete? Is it just you being there just to answer questions they may have? I’m not hearing that they have that process in writing in simplified, easy form.

A. Dr. Whelen – That borders on prescribing how they test. It assumes DOH knows the manufacturing processes of the dispensaries.

Q. Sen. Espero – Isn’t it as simple as taking the flower testing process and transferring it to other products?

A. Dr. Whelen – To a great degree it is. Once they have a verification protocol for one matrix, then transferring that to another concentrate, it is straight forward. But it won’t apply to how other labs do it.

Q. Sen. Espero – So they just need a checklist, no matter how they meet it, and you don’t have that checklist?

A. Dr. Whelen – Well, when we do an audit, we took the Hawaii Administrative Rules (HAR), and created a checklist covering the requirements of the HAR, whether they have validation studies, maintain equipment, have data packets to support it. As a lab scientist, we understand they are lab scientists and will tailor their strategies to their equipment and staff.

Q. Sen. Espero – I hear from non-smoking patients asking. And we don’t have an answer?

A. Dr. Whelen – I believe what the labs tell me. They are close to submitting the appropriate data packages for pesticides. They are approved for CBD profile and heavy metals. But pesticides seem to be taking the most time.

Q. Rep. Belatti – Is there a difference of opinion between the standards the lab division is using and the standards used on the outside? I’m not sure if I’m asking the question the right way. It seems there is a difference of opinion about standards, that DOH may be overzealous on. Are there places where there could be a more happy medium?

A. Dr. Whelen – The process is that labs will come up with protocols and create validation packages. We don’t know that protocol in advance, though we have offered to review it. We will get in the data, it’s like starting in the middle of a story, we have to figure out their approach to the different components, then we have questions and clarifications on that data package and protocols. It is an iterative process to ensure that both entities are in agreement that they are ready to start.

Q. Sen. Baker – So are we asking our dispensaries, our growers, to reinvent the wheel? Surely there are standards other places where it has been in operation for a while, is that true?

A. Dr. Whelen – We are working with a Class I Substance which means there are issues when the data shows spiking.

Q. Sen. Baker – We have CBDs and heavy metals down. Just problems with pesticides—those are the only three we need for manufactured products?

A. Dr. Whelen – And microbial contaminants.

Q. Carl Bergquist – Looking at the Laboratory Certification Status Update, why have no microbial contaminants being submitted?

A. Dr. Whelen – We don’t know why they haven’t submitted anything.

Q. Carl Bergquist – Specific issues with microbial testing?

A. Dr. Whelen – Their efforts were on flower first.

Q. Sen. Baker – So your point is that it is not your kuleana to work with manufacturers to run them through the process to learn what they are doing and what other states are doing to help them through the process?

A. Dr. Whelen – I’m not saying that at all. What is the expectation? We are not performing the analysis, we are just verifying that they are doing it right.

Q. Sen. Baker – I understand, but there seems to be a disconnect between where you are with manufactured products and where the labs may be. Clearly manufactured products are where we need to be. No one wants smoking. This is the biggest issue. How do we get this to move faster? We know dispensaries have product to test if you could test it. Is there some path forward involving more collaboration? Looking at other places?

A. Dr. Whelen – We touch base constantly. We are a regulatory agency in many, many spaces. This is not new to us. We have regulated in many, many spaces. The speed at which something goes is the ability of the laboratories to move forward. It is not simple stuff. It is not easy. Everyone in the room would like it to move forward quicker. I’m willing to do it. I spend half my day on medical cannabis, but the scope of my responsibilities are far beyond that. I have a team of up to nine people that work on submissions. It is a partnership between us and the laboratories. We can do compliance assistance, not focused on enforcement, but assistance. We are trying to get them to where they need to be to where the industry is supported.

Q. Sen. Baker – I would be more comfortable if you had a realistic time frame and were willing to provide additional assistance to labs if they need it.

Q. Rep. San Buenaventura – I’ll ask a different way. I’ll be a nice guy. Have the labs approached you asking for guidance?

A. Dr. Whelen – Yes.

Q. Rep. San Buenaventura – Have you given it to them?

A. Dr. Whelen – Yes, to the best of my knowledge we have given them what they have asked for.

Q. John Paul Bingham, CTAHR – Would integrating the Department of Agriculture pesticide division into the process help?

A. Dr. Whelen – We do pesticides already in water, food. We do all of the testing at the State Lab already, just not on cannabis.

Q. Sen. Baker – Is there something about cannabis that makes the testing harder?

A. Dr. Whelen – It is difficult to do spiking studies on cannabis.

Q. Sen. Baker – On flower or products?

A. Dr. Whelen – It is because of the material requirements for spiking tests. We have had to come up with creative solutions based on the restrictions on the availability of materials for testing. The microbials are a problem, too. The standard is based on a specific standard, 25-gram testing quantities, but we won’t and can’t do that with cannabis. So we are trying to give them the ability to detect microbes in linearization studies with smaller quantities.

Q. Carl Bergquist – So to be clear, there is a lot of stuff not submitted by the laboratories yet. This is not a DOH capacity issue. You could verify that data rather quickly? But you are waiting on the labs, so there is no reason to your knowledge they haven’t been submitted? You’re not worried about the labs running into their own issues or them not knowing what to do?

A. Dr. Whelen – Correct. We touch base with them. The response they give is that they are working on it.

Q. Greg Yim, Phyisician – Can’t you just analyze retroactively? You’re a regulatory agency—just analyze the data after the run tests on real product?

A. Dr. Whelen – It depends on how much risk you want to accept. As a regulatory agency you don’t normally accept that level of risk. You verify an analyte before you start charging for testing. The ongoing audit is certainly part of what we are doing. That will be part of ongoing monitoring. But we need a critical mass of data to show that testing systems are working for analysis in our matrices first.

Q. Greg Yim – What would be the danger of starting testing real product, analyzing the data, and then stopping if there is a problem?

A. Dr. Whelen – The risk is selling product with contaminants that make people sick and of an uncertain potency. So that the patient and dispensary are not providing the quality of product that they want to.

Q. Rep. San Buenaventura – Is there a way to limit that risk? If the buds pass, can we show that those passed before they were made into concentrates? Could you then allow the dispensary to sell concentrates based on the testing of raw ingredients?

A. Dr. Whelen – No. Because you may introducing contaminants during the manufacturing process and from the other materials.

Q. Richard Ha – Lau Ola (Big Island dispensary) – Looking at the handout, it says a dispensary recalled product for some chemicals. But that chemical is allowed for use in Hawai‘i and for use in organic production. Like for tomatoes, we can wash tomatoes, just not the buds. When it heats up, the breakdown product is hydrogen cyanide.

A. Dr. Whelen – That is a Department of Agriculture question. As far as DOH, we just test for pesticides. If it is below one part per million, we are good. These are high standards, even compared to drinking water. There are three steps the Department of Agriculture uses to decide if a pesticide can be used in medical cannabis. The last step is a labeling consultation with DOA. They are the best people to ask whether or not a pesticide can be used. For the lab, we don’t know the branding of the additives, just the chemical compound and whether we need to meet.

Q. Richard Ha – I’m just noting that in Coloardo they banned that chemical and we allow it, and we are supposed to have really strict standards. It’s not a good example.

Q. Wendy Gibson – When all of the labs are certified and up and running. How many islands will be served?

A. Dr. Whelen – All of them. If there is not a lab on the island, then the dispenaries can transport.

Q. Sen. Baker – Moving on from labs, we know labs are on the minds of lots of people.

Q. Greg Yim – If I may, she made a good point that if the flowers test fine, then the manufactured products should test fine. And if both are fine. We are good.

A. Ally Park, Clinical Laboratories/AEOS Labs – That is not always true, because concentrates concentrate things.

Q. Michael Takano – This discussion points to something Cure Oahu mentioned. You might have different product lines based on different ratios. Can we nip this in the bud. If a concentrate is already cleared and you are using different ratios, do you have to test as separate products? Can we have clarity?

A. Dr. Whelen – The intent behind the rules is to test products prior to packaging. That said, there are multiple ways to approach problems sometimes. The rules require statistically significant sampling of a batch. So a manufacture through their manufacturing process is doing QA testing, not regulatory testing in that process. And if they define the characteristics of the final product through that process, assuming it is mixed properly. The verification has to be done that it matches their goal. But the sample size for that testing would be very small. It just has to match expectations.

Q. Sen. Baker – Let me ask this question, just to get some of these products off the ground. If it is just oil, just coming from squeezing the plant or whatever, there is nothing else going into it, you should be able to test that, right? But if it requires additional ingredients, could you test them separately, and then when they are combined, it just has to match explanations? Would that be a way for a breakthrough?

A. Dr. Whelen – That is a decent approach. You have the cannabis tested product. You have the other ingredients product-tested. That is not regulatory testing, that is QA testing, but it defines the goals matrix. That data is available, using the lab to do both analysis. Then the laboratory that is sampling the final product could test a very small portion of the final product.

Q. Ally Park – Two issues—you are certifying the product is safe, the second is CBD/THC per item. Labs shouldn’t certify that. They are not a manufacturing laboratory. The problem is that for each individual pill, you have to test the inert products, which is different for every formula. You can make a methodology, but then the next product has a different formulation. That is the complexity.

Q. Sen. Baker – So you are saying you have to test all of the things that are in it, to give you a true understanding to certify if the product is appropriate.

A. Ally Park – If you want to test the oil and the concentrate, then you test for the base product. But the labs don’t test all of those other products. But we can certify the concentrate or the oil is appropriate.

Q. Sen. Baker – If you have other stuff, then it will be disclosed on the label. What they are trying to disclose is CBD/THC mix, heavy metals, and microbial.

A. Dr. Whelen – Then the gross examination also needs to be done for large objects and moisture content.

Q. Sen. Baker – So to go back to Senator Espero’s question, is there a way to simplify the progress to enable labs to send you the validation data packets?

A. Dr. Whelen – I will ask the labs again if there is anything DOH can do to help move them along.

Q. Greg Yim – Is it appropriate to ask the lab representatives who are all in the room now?

A. Sen. Baker – No.

Q. Sen. Espero – Regarding other products—I’m gonna guess that oil is a straightforward simple product you can test today. Could you certify that an oil is ready to be sold?

A. Dr. Whelen – No. We have no validation studies for oil. The issue is still pesticides and microbial.

Q. Sen. Espero – Oils are out there in other states. Patients can do their own. But you are saying, even something as simple as oil, requires the validation studies.

A. Rep. Belatti – A lot can happen in a month. We are hopeful and moving on.

Tracking System Update

Danette Wong Tomiyasu – Regarding the software tracking system. We are serious about product safety.

To wrap up – BioTrack and the registry and software system are integrated and the glitches have been worked out with both Maui Grown Therapies and Aloha Green.

There have been a few issues in post opening inspections. One was early entry of a patient prior to actually getting a card—they entered with a form. We are educating people. The second issue was card renewals. We issue a card, but for 30 days before the expiration, they can apply and receive a new card. But they have to use the old card until it expires. These issues we are working through.

Tracking programs have been integrated with the lab’s. Steephill is in the system. We are working with the other labs.

Transportation  to labs—we have developed new rules and will be working with labs and dispensaries prior to publication.

We remind patients to use their current card until it expires before they use there now card.

Can we recognize that Tammy Whitney and Peter Whiticar will oversee the Registry Program until Scottina is replaced?

Questions and Comments from the Public

Q. Michael Rollins, PharmLabs Hawaii – Thank you for your time. I do want to commend Dr. Whelen and his staff. They are staying in communication with us. They mentioned this is the first time the Department is dealing with this material. Our lab has been working with this material for many years. We work with national accrediting bodies for ISO accreditation. We feel these accreditors are the experts. That policy and procedure is inherently easier than DOH’s requirements. Labs are trying to work with DOH to provide things above the ISO accreditation (required in the Administrative Rules). But consistently, we are compared to the other forms of testing DOH regularly does like water. So we have felt it is easier to do what we are told rather than iron things out. I think it is horrible that we haven’t been meeting to talk. There has been no laboratory subcommittee group meetings, there needs to be a better gathering to solve these problems. The biggest issues is that this will continue to go on as the dispensaries expand their product lines. For instance, sugar reduces THC content. This is about preparation, emulsions, extracts—it is about spiking and methodology. The methods don’t change, it is the sample prep. The labs need to be trusted to create the methods and procedures for sampling and testing. If we have to seek validation for every product, then we will be slowed down. I think DOH needs to be aware of this issue and given more guidance.

Q. Brian Goldstein, Manoa Botanicals (O‘ahu dispensary) – I appreciate Greg’s comment. There is a fundamental flaw in that you are asking an agency that doesn’t test cannabis to certify cannabis. Oregon just says if you meet ISO certification, you can begin testing. Then they do round robin samples. Sending samples to every lab to see if they test accurately. So to require pre-certification of labs that are in multiple states and countries is completely backwards. That is the flaw in the system.

A. Sen. Baker – Maybe DOH could convene the lab folks and see how they could work together. Thank you.

Manufacturing Product Discussion

Sen. Rosalyn Baker – There are two things I am handing out. They will be online. One is some work that Mike Takano has put together. There is a discussion and some minutes from the working group subcommittee on manufactured products. It is a good basis for the discussion. The other thing we are passing out is a one-sheet that is a recommendation for a rule change. One of the things that has come up—let me say this as a baseline—statute is the law. DOH is to implement the law. They will be in the process of updating the rules to be consistent with the law. One of the things that has come up is the issue of nebulizers, atomizers, etc. Some of us who have been dealing with issues of tobacco use, we don’t want anything that looks like we are favoring e-cigarettes. But we were given some language that talks about how we might address the issue of nebulizers or volumization of cannabis oil so it is not combusted, not smoked, but still a method of delivery. Basically, I want the Working Group to consider adding:

“with the exception of pre-filled and sealed medical-grade containers used to aerosolize and deliver cannabis orally, such as a medical-grade inhaler, medical-grade nebulizer or other medical-grade volitization device that is regulated to prevent the combustion of cannabis oil and is made of materials that do not interact chemically with the manufactured medical cannabis products contained therein,”

so that we set for what can be sold, manufactured, or used, that will allow people to not have to smoke or ingest something to get it into their system quickly. We wanted to pass this out for the Working Group to process.

Representative Della Au Belatti – Over the last two Working Group meetings, we had questions about nebulizers and similar devices. This language would allow for volatilization devices that are like vape pens, but not actually a vape pen—specifically, we’re not calling it a vape pen. This will address issues raised previously by Michael Takano and Brian Goldstein. As you can see from this language, the key words are pre-filled and medical grade containers that are used to aerosolize.

Senator Rosalyn Baker – The only appropriate materials are stainless steel and glass.

Q. Greg Yim, Physician – Why is this appropriate? Is it consistent with Act 230? It says no rubber, so it won’t degrade. The best way to deliver small amounts in pre-measured doses, sub-combustion, prior to activation. This makes sense for the endocannabinoid system.

Q. Ally Park, Clinical Laboratories/AEOS Labs – So not a plastic device?

A. Greg Yim – No, it has to be a glass or steel cartridge in a glass or steel device.

Q. Rep. San Buenaventura – So it looks like something that could go into a vape pen, but we won’t call it that?

A. Greg Yim – Yes.

Rep. Belatti – We don’t want to see a marijuana cigarette. We want to move away from smoking.  Whereas the vaping of oils in quality containers is safer. We feel we could recommend it to the Department of Health.

Q. Sen. Baker – Could you describe the product that the dispensaries might be able to utilize?

A. Chris Cole – Director of Product Development, Maui Grown Therapies – One of the issues with vape pens is they are made of plastic. That is bad, it interacts badly with cannabis oil and doesn’t control temperature well. Our product is stainless steel or glass so it doesn’t interact with cannabis oil. It will deliver into the lungs at sub-combustion temperatures. So no combustible compounds.

Q. Michael Takano – A few concerns—the anti-smoking law and being sensitive to that. Also, from a law enforcement standpoint, there is an anti-smoking law, and we want to prevent people from being accused of smoking marijuana when they are not. While we may not be able to achieve precisely metered doses, we could control dosing on the cartridge level, since the goal is to make things simple. This is a modest change to this provision and standard. We just want to have DOH make the change because they have authority. The easiest fix.

Q. Sen. Baker – Does the oil smell like weed if it is volatilized?

A. Chris Cole – Yes, but less so.

Q. Sen. Baker – Is there a way, I’m thinking this product that this could be something that visitors could ultimately come and use, but if there is a smell and looks like smoking, then there is no place for visitors to use weed. Is there a way to make the smell be taken out of the oil?

A. Chris Cole – To a large extent. I can’t commit, but some of the compounds in the plant responsible for the therapeutic effects are responsible for the aromas. I also want to point to another part of the rules that says products can’t be sold for inhalation of any kind.

A. Sen. Baker – We fixed that in the statute last year.

Q. Chris Cole – The Hawaii Revised Statutes trumps the Hawaii Administrative Rules then?

A. Sen. Baker – Yes, that is the great irony. For folks that don’t want anyone smoking, we’ve put them in a position that if you want medical grade marijuana, that is all you can do.

A. Chris Cole – There is a lot of good peer reviewed literature on inhaling cannabis oil at subcombustion temperatures is not dangerous like the rest of smoking products which do.

Rep. Belatti – A technical point, when adding the nebulizer, we trumped the no inhalation provision. I think that because we have fixed the inhalation issue, the best solution is just a rule change for the interim rules. Are we ready for a recommendation? DOH hasn’t had time to review the change. Maybe at the next Working Group meeting we can have a report on whether it could be integrated into the rules.

Q. Richard Ha – I got my card three months ago. The difference between smoking and vaporizing is huge. Smoking you worry about your neighbor. If using a vaporizer, even a pen, from me to my wife, you could not tell. There is a huge difference.

Rep. Belatti – Officially then, is it OK to refer the proposal to DOH for consideration?

Working Group – Yes.

Rep. Belatti – Thank you. With the other packet – please review regarding the Products Subcommittee. There are lots of recommendations for us to discuss at next meeting.

Subcommittee Breakout and Reports

Next the Committee received several subcommittee reports, the rest were postponed until the next Working Group meeting because of timing considerations.

Licensing – Chair Rep. Joy San Buenaventura

Rep. San Buenaventura – Since the last breakout session, Keith Ridley was supposed to get back to me, but he didn’t about if there were any legal problems with the license certification processes of DOH. He believes we are good to restart licensing procedures. The issues were method, not substance. He is supposed to report on monies and staffing he would need to restart the application process. The law said we were supposed evaluate every year, but because of delays, we postponed. The question is if we should restart for 2019 (Ed. Note, 2018). Since there is a huge demand, few dispensaries, and they are selling out, we should restart the licensing process. Further discussions will be held. There doesn’t seem to be any objections to at least a production license, like the Colorado model. Subcommittee doesn’t see objections to production licenses. Current licensees will be grandfathered in. If production licenses, then there will be a different set of factors and application procedures that needs to be vetted out. It is just a recommendation from the subcommittee. We want to support the existing licenses because they have been vetted. We want a healthy industry. It seems that there is movement and ability for growth.

Richard Ha – I’m on that subcommittee—my feeling is that we need to study this. We have no idea if the patient growth will be permanent or if the running out will continue to happen. And also the dispensary side, we have a lot of money in this. I can’t recommend it.

Rep. San Buenaventura – That is the discussion—how do we support the dispensaries and make good changes. It is a discussion. As far as the production licenses, that would decrease the cost for the dispensaries. That has been shown by mainland industries where they have been able to buy from different producers. Current licensees have a head start. We have a need, but it has not been met.

Rep. Au Belatti – Can I comment? Now the issues have been thrown to the larger group. I agree there is pent-up demand. There is not enough supply. But only two dispensaries are open. We need more discussion and research by the group. Maybe a direction would be to get direction, we need more data.

Rep. San Buenaventura – I’m not saying fulling horizontal, with all kinds of licenses. This is just vertical plus production. Washington, CSG and CSL (conferences of state legislators) say their systems are the most robust, and they are full horizontal. They say it is better than vertical when talking with federal DOJ. I’m just saying at least going back to the track we started in 2013, issuing more licenses, and thinking about production licenses later on.

Sen. Baker – There is one element that emerged from our tour of national meetings. You must know your black market. You must quantify the black market and know it is there. I believe that UHERO had done some initial work on the black market and we had tasked DBEDT to look at this. They should come share the preliminary analysis. What we are hoping the legal market will be sufficiently diverse and robust and free of pesticides to get people to switch. But we need to understand the competition.

Rep. Au Belatti – To clarify, UHERO has a study on recreational laws in Hawai‘i. DBEDT has a requirement to work with DOH to work on the collection of data. We need to bring that on board. Now we will reach out to both agencies to see if they can inform the discussion next meeting.

Education – Chairs, Stacy Kracher, APRN/Wendy Gibson, MCCHI

Report postponed.

Product – Chair, Sen. Rosalyn Baker

Report postponed for review, see above.

Reciprocity – Chair, Rep. Della Au Belatti

Report postponed.

Patients – Chair, Carl Bergquist, Drug Policy Forum

Report postponed.

Public Input

The floor was then opened for public comments.

Q. Pamela Lichty, Drug Policy Forum – I’ve been involved in the process since the beginning. We always said all along not to reinvent the wheel. There is some good news, bad news. We finally passed a law, and we said we would learn from the other states. But I feel like we are still reinventing the wheel on every single angle. I like what Richard Ha said when he signed up to see what it is about. I’m still hearing naïve questions, like what is the smell like. All of you have visited legalized states. I respectfully suggest you watch them and at least learn the common sense stuff. Like whether vaping smells a little, but not nearly enough and is very fleeting. I know many of you have made those trips. There are so many examples. We are so far behind the curve, I would like to see things expedited.

A. Sen. Baker – I appreciate your comments. Those of us that are policy makers, with all due respect Pam, what we are looking for, is when we have the statute where it is, but where does it need to go. Some of those issues can be taken out of the statute, some can be made broader. I always tell people that Hawai‘i is very blue in some regards and very red in others. Because we have baby steps, we are probably in better stead in some places than other states. Because we are getting the collective knowledge we can update the statue and the regulations and we can be in a better place. We appreciate all the input we can get and the hard work. It needs to be a collective effort. There are a lot of people who need the medicine.

A. Belatti – I’d love to respond to Pamela Lichty, too. We can’t compare to Washington or Oregon. We should be compared to Maryland and New York. We are doing well compared to them. I beg to differ with Pam. We have been taking our time, and I’m grateful we are using the standards we are. We will have patient safety. Is it too high? We will have to strike a balance. We need to compare ourselves to the right states. We are not recreational, and I fear in this regulatory environment we will be in trouble if we go recreational. We are going slow to our economic detriment, we will push where we can. We are working as hard as we can.

Q. Dana Ciccone, Steephill Labs – I know the hot topic was the lab and certification for manufactured products. It is a lot of hard work to get the validation studies done. I can’t snap my finger and please DOH. There is a method to their madness. They have a lot of good points and steered us in the right direction. I have helped us realize the difficulty and how much is needed throughout the process. They are easy to work with. Strictest standards in the nation, but easy to work with. Manufactured products will be soon. We are almost done with our validation studies, maybe within a week.  The real story is not certification, but how they are going to package. It is going to be a total cluster. When I was on the task force, it was supposed to be about edibles. How are they going to package in 10 mg doses? We are frustrated. DOH is doing their job, I appreciate them. It is what it is. Hopefully there will be changes soon.

Q. Michael Rollins – Quick clarification regarding testing water versus cannabis. I don’t mean standards, those vary, but the methods can be very different. I’m anxiously awaiting the new transportation issues for testing. We need to hire staff and train them. We shouldn’t be restricting access to labs. If a lab is fully operational, why no competition on that island? There is no difference, all shipment is regulated. Why not rewriting the law to show all the labs can be made to serve all of the islands. A topic for the future.

Next Steps and Announcements

Review of April and July Meeting Minutes – Minor technical corrections. Minutes approved. Available here.

Announcement: To get on the email list, go to Act230wg@gmail.com. All updates are also posted to the Act 230 website.

Next Meeting: 

The next meeting will likely occur on September 20, 2-4 pm. Details to come. Stay tuned!

Adjournment

Conclusion

2016-10-12-leg-oversight-committee-2Now it is your turn! The Alliance has a role on the Committee and access to each of the subcommittees – Products, Education, Patients, Reciprocity, Licenses, and Laboratories. We need your thoughts, comments, and detailed considerations for any and all of these committee priorities that you would like to see action or deliberation on. What did we miss? What do you think we should emphasize? The Legislative Oversight Committee will generate the successful legislative and administrative progress the industry needs in the coming years, and this is your opportunity to guide our hand.

We want to know what you think! Email us at info@hawaiidispensaryalliance.org if you have any suggestions or comments, find us on Facebook, Contact Us through this website, or give us a call anytime. You are invited to be as broad or specific with your submissions as possible.

Mahalo nui for your continued support as we build a better future for Hawai‘i’s legitimate cannabis industry!

It is the Alliance’s mission to provide up-to-date and relevant industry information to the patients, dispensary applicants, and related businesses of Hawai‘i’s growing medicinal cannabis industry. If you are not yet an Alliance member, join today to receive the HDA Industry Update every month and to take an active role in the future of Hawai‘i’s medical marijuana industry. Contact us today and we will send you the Winter 2017 edition of the HDA Industry Update absolutely free to say thank you for your interest!

August Meeting Notes from the Act 230 Working Group – Laboratory Delays Continue