P.1

Kevin B. Gilnack

Executive Director

Commonwealth Dispensary Association

13 Commercial Way

Milford, MA 01757

January 6, 2017

Executive Office of Health and HumanServices Department of PublicHealth

Bureau of Health Care Safety andQuality

Medical Use of MarijuanaProgram

99 Chauncy Street, 11th Floor, Boston, MA02111

RE: Proposed changes to 105 CMR 725.000

To Whom It May Concern:

I am writing you on behalf of the Commonwealth Dispensary Association (CDA), which represents Registered Marijuana Dispensaries (RMDs) that have received provisional or final certificates of registration to provide cannabis medicines to qualified patients in Massachusetts. The purpose of this letter is to provide feedback regarding proposed changes to 105 CMR 725.000: Implementation of An Act for the Humanitarian Medical Use of Marijuana (the Regulations or 105 CMR 725.000) as presented at the meeting of the Public Health Council on September 14, 2016, based on the input of members of our responsible, regulated dispensary industry.

We are grateful to Department of Public Health (DPH) Commissioner Bharel, her staff, and the Medical Use of Marijuana Program (the Program) team for the significant amount of thought and effort reflected in these draft changes, and for the open and accessible process used to gather stakeholder input in formulating these changes.

There are a number of changes proposed in these revisions that will help expand patient access to safe cannabis medicinesthat we encourage you to preserve in the final promulgated regulations. However, thereare also a number of opportunities to build on this progress and further improve the regulations in the spirit of supporting patients and the goals of Governor Charles Baker’s Executive Order 562 (the Order).

Specifically, in light of the passage of Question 4 on the 2016 ballot, which legalizes the sale of cannabis to adults, there are some changes that are critical to ensuring that we maintain a robust medical use of marijuana program by removing barriers to patients and RMDs. These changes include the issue raised in our other letter submitted today regarding how the Program regulates financial compliance,as well as additional issues raised below related to ensuring that barriers to patient participation are removed. Additionally, as addressed below, there are a number of additional changes that will strengthen the program by enabling RMDs to best provide patients with access to safe cannabis medicines without undue burdens.

  1. Background

Medical Use of Marijuana Program Regulation and Statute

105 CMR 725.000: Implementation of An Act For The Humanitarian Medical Use OfMarijuana establishes regulations governing dispensaries, physicians, caregivers, and patients related to and authorized by Chapter 369 of the Acts of 2012, An Act for the Humanitarian Medical Use of Marijuana (the Act). The Act was approved by more than 63 percent of Massachusetts voters for the purpose of legalizing and regulating access to cannabis medicines for qualified patients. Before promulgating final regulations, DPH will continue to receive stakeholder input, schedule a public hearing on proposed changes to the Regulations, and accept written testimony for 10 days following the public hearing.

Federal Guidance

The United States Department of Justice Memorandum dated August 29, 2013 entitled: Guidance Regarding Marijuana Enforcement (the Cole memo) details the circumstances under which the federal authorities would intervene in state-legal marijuana programs.

The Cole memo outlines eight specific enforcement priorities related to preventing diversion to minors and states where marijuana is not legal; severing ties to criminal elements and illegal activities; preventing violence, impaired driving, growing on public lands, and use or possession on federal land. It also notes that its guidance “rests on its expectation that state and local governments that have enacted laws authorizing marijuana-related conduct will implement strong and effective regulatory and enforcement systems that will address the threat those state laws could pose to public safety, public health, and other law enforcement interests.”

Executive Order 562

Last year, DPH began a process of reviewing 105 CMR 725.000, as well as all other program regulations, in accordance with Executive Order 562. DPH conducted an inclusive process of soliciting input from diverse stakeholders related to the Program, staff developed proposed changes that advance the goals of the Order and the Act, while ensuring rigorous compliance with the Cole memo.

According to the Order, each secretariat, agency, department, board, commission, authority, or other body within the Executive Department (Agency), must undertake a review of each and every regulation currently published in the Code of Massachusetts Regulations under its jurisdiction. The Agency must sunset all its regulations by March 31, 2016 and is conducting a review of current regulations before rescinding, revising, or simplifying them as appropriate based on this review.

Pursuant to Section 3 of the Order, only those regulations that are mandated by law or essential to the health, safety, environment or welfare of the Commonwealth's residents shall be retained or modified. In order to find that a regulation meets this standard, the Agency must demonstrate in its review that:

  1. there is a clearly identified need for governmental intervention that is best addressed by the Agency and not another Agency or governmental body;
  2. the costs of the regulation do not exceed the benefits that would result from the regulation;
  3. the regulation does not exceed federal requirements or duplicate local requirements;
  4. less restrictive and intrusive alternatives have been considered and found less desirable based on a sound evaluation of the alternatives;
  5. the regulation does not unduly and adversely affect Massachusetts citizens and customers of the Commonwealth, or the competitive environment in Massachusetts;
  6. the Agency has established a process and a schedule for measuring the effectiveness of the regulation; and
  7. the regulation is time-limited or provides for regular review.

Furthermore, according to Section 6 of the Order, “each Agency shall prepare in connection with any proposed, new regulation a business/competitiveness impact statement that will include a competitiveness review and assess disruptive economic impacts on small businesses, as required by G.L. c. 30A, § 5, and all other potentially impacted entities, including cities and towns, non-profit organizations and medium and large for profit enterprises, as prescribed and for such period of time as desired by the Secretary of Administration and Finance, notwithstanding the effective date of this Order. Such business/competitiveness impact statements will be made available on the Commonwealth’s website.”

  1. Opportunities for further improvement

While there are a number of proposed changes that will significantly expand safe access to cannabis medicine for qualified patients, there are several additional changes that should be incorporated into the final regulations to further advance the goals of the Executive Order and of expanding access to safe cannabis medicine for qualified patients.

Ensure all RMDs have an opportunity to provide robust selections of cannabis medicines through additional cultivation inputs

725.105(N)(2) A RMD may not acquire marijuana or marijuana plants except through the cultivation of marijuana by that RMD or another RMD as specified in 105 CMR 725.105(B)(2), provided however that a RMD may acquire marijuana seeds, cuttings or genetic plant material that are not flowering and are no taller than 8 inches wide and no wider than 8 inches tall. Cuttings or genetic plant material may only be acquired within 90 days of receiving a final certificate of registration, except as authorized under 105 CMR 725.105(B)(2).

The CDA and our members applaud DPH for proposing changes to 105 CMR 725.105(N)(2) that have the potential to significantly increase the availability of cannabis medicines by authorizing RMDs to cultivate from cuttings and genetic plant material acquired within 90 days of the issuance of their final certificate of registration. However, as currently worded, this language does not authorized RMDs that have already received their final certificate of registration for expanding their ability to best meet patient needs.

Based on the draft proposed change, it is clear that the Department recognizes that the previous wording of this section of the Regulations conflicted with Executive Order 562 because it unduly burdens and adversely affects Massachusetts citizens and its competitive environment, the costs of the regulation exceeds any potential or perceived benefits, a less restrictive and intrusive alternative would be more desirable.

In furtherance of the goals of Executive Order 562 and the goals of the Act, which seeks to ensure all qualified registered patients have access to a robust selection of cannabis medicines from dispensaries, we urge the Department to further refine this language. Specifically, we encourage DPH to ensure RMDs that have already received a final certificate or registration have the ability to cultivate from cuttings or genetic plant material for 90 days of the effective date of these revised regulations. Failure to address the omission of existing RMDs would conflict with the Executive Order by unduly and adversely affecting the patients served by operational RMDs and negatively impact the competitive environment in Massachusetts.

Providing operational RMDs with a 90-day window in which to pursue cultivation from cuttings and genetic materials would ensure that the RMDs that are on the front lines of serving the greatest number of patients in Massachusetts would be able to obtain strains they have been unable to cultivate from seeds, in particular high-CBD strains, which are especially challenging to acquire and are critical to providing an effective, non-psychoactive treatment for pediatric patients and adults suffering from seizure disorders and other debilitating conditions.

Propagation from cuttings or grafting yields the following benefits:

  1. The main advantage of using cuttings for propagation is that the new plants contain the genetic material of only one parent, so they are essentially clones of the parent plant. Plants grown from seed will often be different from the parent plant and from each other. This means that when propagated from cuttings, one can reproduce a plant with desirable traits indefinitely, as long as the growing conditions remain similar. For example, if the parent plant has a particular cannabinoid profile, the new plant grown from the cutting will have the same profile. This is especially important for commercial growers who want to reproduce the highest-quality plants and ensure consistency of a plant or crop.
  1. Propagating a new plant via cuttings avoids the potential of crop failure. Usable marijuana medicine is produced from the unfertilized female cannabis plant. Male cannabis plants do not produce the inflorescences from which all marijuana medicine is derived. Moreover, male plants that are comingled with female plants threaten the viability of an entire crop by having the potential to fertilize the female plants. Once fertilized, female cannabis plants are rendered nearly useless in medicine production. Indeed, the consequences of even one male plant in the cultivation area are dire. One male plant can seed the other female plants, which has the potential to diminish or destroy all cultivation. The process of finding male plants is difficult and time consuming. Every plant needs to be analyzed multiple times in a period of weeks. In a commercial cultivation facility with thousands of plants, that is a difficult and risky task. When propagated from cuttings, if the parent plant is female, the new plant will also be female.
  1. A new plant grown from a cutting will frequently mature faster and flower sooner than a plant grown from a seed. Additionally, some seeds are difficult to germinate, and have a high failure rate.

Without further revision to this section of the regulations, operational RMDs will continue to be unduly and adversely affected by increased production costs, which include:

(1)Need for procurement of a tremendous number of seeds, the vast majority of which will never be used for medicine production either because they turn out to be male, or because their phenotype does not turn out to be conducive to producing high quality cannabis medicine;

(2)added labor costs to cultivate plants that will never be used;

(3)added input and waste costs such as electricity, water and nutrients to cultivate plants that will never be used;

(4)added labor costs to sex plants;

(5)added equipment and space requirements to cultivate more plants than will ever be viable for production of medicine;

(6)added administrative costs in the planning of extensive breeding, sexing and cultivation programs that would not need to exist if propagation were performed from cuttings; and

(7)added risk to crop failure if a missed male or hermaphridic plant releases pollen.

Providing existing RMDs with a 90-day window in which they can cultivate from cuttings or genetic materials offers a less burdensome and less costly alternative to the existing proposed language. It will also provide the most immediate benefit in terms of diversifying the availability of strains for qualified registered patients, particularly some of our most vulnerable patients who require new strains that have a high percentage of CBD. We strongly urge DPH to encourage the Public Health Commission to adopt the following modified language.

Suggested language:

725.105(N)(2) A RMD may not acquire marijuana or marijuana plants except through the cultivation of marijuana by that RMD or another RMD as specified in 105 CMR 725.105(B)(2), provided however that a RMD may acquire marijuana seeds, plant cuttings or other genetic plant material that are not flowering and are no taller than 8 inches wide and no wider than 8 inches tall. Cuttings or genetic plant material may only be acquired within 90 days of receiving a final certificate of registration or within 90 days of the effective date of these regulations for RMDs that have already received a final certificate of registration at the time they are promulgated, except as authorized under 105 CMR 725.105(B)(2).

Expand the availability of diverse cannabis medicines for patients through expanded wholesaling between RMDs

725.105(B)(2) A RMD may acquire marijuana from or distribute marijuana to another RMD when:

(a) An documented emergency situation occurs such as loss of crop, vandalism, or theft, or other circumstance as approved by the Department; or

(b) A specific registered qualifying patient’s needs cannot otherwise be met by the acquiring RMD, as documented by the acquiring RMD; and

(bc) The distribution and acquisition of marijuana, except MIPs, to and from all other RMDs does not exceed, cumulatively, 30% of the RMD’s total annual inventory of marijuana; and.

(c) The distribution and acquisition of MIPs to and from all other RMDs does not exceed, cumulatively, 30% of the RMD’s total annual inventory of MIPs.

The CDA appreciates that DPH has proposed an important first step in expanding patient access to a wide variety of cannabis medicines by allowing RMDs to sell up to 30% of their inventory of marijuana and 30% of their inventory of MIPs to other RMDs that may not have the capacity to cultivate or manufacture those products for their patients.

The CDA further appreciates the Program’s desire to ensure that RMDs operate primarily as seed-to-sale vertically integrated entities that are founded for the purposes of cultivating, manufacturing, and selling cannabis medicines to qualified patients.

While the proposed changes represent an important first step expanding safe access to cannabis medicine and reconciling the Regulations with the Executive Order, the limit of 30% unnecessarily limits patient access to medicines; the costs of this limit exceeds any perceived benefit it may provide; a less restrictive and intrusive alternative is more desirable; and the regulation unduly and adversely burdens Massachusetts citizens, customers, and the Commonwealth’s competitive environment.

Before promulgating these regulations, the CDA recommends further revising this section to change the limit on distributing and acquiring cannabis and cannabis products from 30% to 45%. This change will greatly facilitate the ability of RMDs to acquire and provide each other and their patients with a substantially more diverse selection of medicines for qualified patients, while ensuring that the majority of products an RMD produces are provided to the patients they were founded to serve.

This alternative advances the goal of the Act – to ensure qualified registered patients have access to the safe cannabis medicines they need – as well as the Executive Order. Specifically, this alternative will foster greater competition among RMDs and reduce any undue and adverse burdens on Massachusetts citizens and customers (both patients and RMD operators). Furthermore, this change represents a less restrictive and intrusive alternative, which also reduces the negative impact of the regulation without limiting the benefit of this limitation (preserving our vertically integrated dispensary model).

Suggested language:

725.105(B)(2) A RMD may acquire marijuana from or distribute marijuana to another RMD when:

(a) An documented emergency situation occurs such as loss of crop, vandalism, or theft, or other circumstance as approved by the Department; or

(b) A specific registered qualifying patient’s needs cannot otherwise be met by the acquiring RMD, as documented by the acquiring RMD; and

(bc) The distribution and acquisition of marijuana, except MIPs, to and from all other RMDs does not exceed, cumulatively, 30% 45% of the RMD’s total annual inventory of marijuana; and.

(c) The distribution and acquisition of MIPs to and from all other RMDs does not exceed, cumulatively, 30% 45% of the RMD’s total annual inventory of MIPs.

Protect patient safety while reducing unnecessary burdens on RMDs, testing labs, and DPHby modifying reporting requirements for testing results

725.105(C)(2)(c) The RMD must have and follow a policy and procedure for responding to results indicating contamination, which shall include notification by the RMD and the independent testing laboratory separately and directly to the Department of any results indicating contamination within 72 hours,which shall include destruction of contaminated product, and assessment of the source of contamination. Such policy shall be available to registered qualifying patients and personal caregivers;