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A Proposal to Establish a Comprehensive Cannabis Varietal Registry in Washington State

A collaboration between VisionWashington LLC. and The Center for the Study of Cannabis and Social Policy

CO-AUTHORS:

David J. Mighell, Dominic Corva1, Michelle Sexton2

REVIEW, CRITIQUE AND ENDORSEMENT:

Sunil Aggarwal3, Gregory T. Carter4

June 10, 2013

Contents Introducing the Proposal ....................................................................................................................................... 2

About Us ........................................................................................................................................................ 2

The Current State of Cannabis Phytochemical Analysis ........................................................................................ 4

The Scientific Basis for a Cannabis Varietal Registry (CVR) .................................................................................... 5

The CVR Will Significantly Inform Commercial Research ....................................................................................... 6

The CVR Will Significantly Inform Medical Research ............................................................................................. 6

The CVR Will Richly Inform Current and Potential Cannabis Consumers .............................................................. 7

Conclusion ............................................................................................................................................................. 8

1 Ph.D., Geography, University of Washington; Assistant Professor, Political Geography, Sarah Lawrence College; Founder, Center for the Study of Cannabis and Social Policy, Seattle, WA 2 ND, Bastyr University Research Institute Faculty; Postdoctoral Fellow, University of Washington, 2008-2011 3 M.D., Ph.D (Medical Geography, University of Washington), Resident, NYU Langone Medical Center 4 M.D., MS. Professor, Department of Rehabilitation Medicine, University of Washington; Physiatrist, Providence Medical Group, Author, Scientific Basis supporting Gov. Gregoire’s 2011 Cannabis Reclassification Petition

http://www.linkedin.com/search?search=&keywords=Geography&sortCriteria=R&keepFacets=true&trk=prof-edu-field_of_studyhttp://www.linkedin.com/search?search=&title=Postdoctoral+Fellow&sortCriteria=R&keepFacets=true&currentTitle=CP&trk=prof-exp-titlehttp://www.linkedin.com/company/2584?trk=prof-exp-company-name

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Introducing the Proposal Current analytic methods for identifying and tracking cannabis cultivars (“strains”) currently test for THC,

CBD and CBN content, which constitute only three of the approximately 30 principal chemical compounds

represented in cannabis varietals in various proportions. In fact, it is the precise combination of the secondary

metabolites – terpenes, flavonoids and minor cannabinoids - that are responsible for various qualities of the

human/plant biochemical interaction. The authors assert that capturing and understanding a more complex and

precise profile of commercial cannabis products is necessary to inform enlightened policy regulation.

At the same time, scientists have now demonstrated the means to reliably capture exhaustive chemical profiles

of plant matter, and importantly, have demonstrated methods to use the resulting quantitative data to

chemically distinguish cannabis varietals from one another. This means that we now have the capability to

classify cannabis strains by common compositional relationships, and identify morphological change in plants

over time and responsive to growing conditions. Thus, we can baseline cannabis products made available to

Washington consumers, and manage important dimensions of product continuity and quality assurance that are

not currently addressed in draft regulations.

We propose to establish a lab in Washington State that can collect comprehensive cultivar profiles and analyze

them in support of Washington State policy goals, in particular the need to establish analytic standards that are

based on robust scientific data that currently does not exist. The data collection and analysis done by the lab

will be used to create a comprehensive Cannabis Varietal Registry based on chemo-taxonomic analytical

methods that are far more comprehensive and informative than we expect to be reflected in final rules for

recurrent crop testing for safety and potency.

The Cannabis Strain Registry shall be:

A single lab, site, with dedicated staff and purpose

Driven by the common needs of Consumers, medical science and Washington’s Cannabis Industry

Fully Transparent, non-profit

Sustained by user fees (producers and processors)

In-service to medical and commercial research by freely publishing the most comprehensive biological

information on cannabis in existence

Responsible to Consumers and the industry for the same reason

A one-time requirement for the collection of a baseline profile for all strains brought to market

While the requirements for the Cannabis Varietal Registry could be equally satisfied by public or private

resources, we see this as an ideal opportunity to express the aligned interests of the state and the private

cannabis industry.

About Us The Proposal is a collaboration between VisionWashington LLC. and the Center for the Study of Cannabis and

Social Policy.

VisionWashington LLC. began in 2011 as a rolling conversation among colleagues - veterans of Washington's

software industry interested in the implications of our state's commercial cannabis initiative and its parallels in

our experience in emerging industries. We have partnered with the Seattle-based Center for the Study of

Cannabis and Social Research to create this proposal, but the impetus and development of its ideas are rooted

in the process started by VisionWashington.

The Center for the Study of Cannabis and Social Research was established to produce, review, and disseminate

objective research and opinions about the relationship between Cannabis Policy and other forms of Social Policy

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including but not limited to Environmental Policy, Agricultural Policy, Public Health Policy, Foreign Policy, and

Economic Policy. This proposal is one of many policy research projects the Center hopes to house.

VisonWashington understood from their experience at Microsoft, Intel and elsewhere, that the dawn of an

entirely new industry is an opportunity to set precedence, to impart convention, establish customs and methods

that can become industry-wide standards as the eco-system evolves. Characteristic of Washington’s foremost

technology companies in their finest hours has been foresight and decisiveness at key moments in the evolution

of their respective industries. We assert that this is just such a moment for Washington and for the Cannabis

Industry.

We began with the following question: How could Washington shape administrative rules that might leverage

its unique status as “premier industry declarant” into one of “cardinal industry authority,” and in doing so

establish a premium market reputation for leadership in industry and regulatory practice that could be reflected

in the value of Washington cannabis products ad infinitum.

After extensive literature review, we have come to the observation that the biological study of cannabis has

been so limited that there exists no classification system or taxonomy to describe types beneath three primary

phenotypes. At the same time, we found that it has only now been clearly demonstrated that strains can be

identified and grouped by chemotaxonomic similarities. What is missing is a scientifically relevant sample

population of cannabis producers, and that is the opportunity that has been made possible for the first time by

the passage of I-502. We expect that our project will help shape industry standards in Washington State, and

that our results will guide industry standards in future legalization policy development in other states as they

look to Washington and Colorado models.

The opportunity to be seized: The emergence of the world’s first measurable class of regulated cultivators:

Scores of licensed producers - already subject to testing rigor

Producing scores of varietals for the commercial market

Our principal objectives in the realization of this opportunity:

The development of the world’s first and foremost scientifically authoritative chemotaxonomic dataset

of cannabis cultivars

And from that study, the development of a cannabis phenotype classification system

In sum, Washington has the opportunity to deliver a wellspring of new learning and scientific data to inform best

practices for regulatory policy, as well as medical and commercial research for years to come.

We assert that our recommendation for the establishment of the Washington State Cannabis Varietal Registry

broadly serves the interests of all stakeholder/constituents:

Science

Medicine

Education

Patients

Consumers

The WA Cannabis Industry

Regulators

The objective of this document is to describe exactly how.

We begin by assessing the current state of cannabis chemotaxonomic research, elaborate on how our proposed

Registry will inform commercial research, medical research, and consumer knowledge necessary for making

informed consumption decisions.

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The Current State of Cannabis Phytochemical Analysis Effective policy reflects authoritative knowledge about the reality it addresses. At this stage, authoritative

scientific knowledge of cannabis – medical, social and biological – is behind the curve, and this presents a major

challenge for producing effective policy.

The 1961 Single Convention on Narcotic Drugs along with two other treaties restricted scientific establishments

in the USA from studying Cannabis without approval of the DEA. Here, under schedule I, Cannabis currently is

classified as if there is no current accepted medical use, which has deeply undermined the potential to explore

or define the medical value. The consequence has been that the public has taken on their own uncontrolled

clinical trial, and become the experts on the medical utility of the plant.

To better understand the medicinal value of botanical medicines, it is necessary to look beyond the common

macronutrients of protein content, fats, carbohydrate, and focus on the secondary metabolites that are

responsible for the human/plant biochemical interaction. The two primary constituents, delta9-THC and

Cannabidiol (CBD) have gained most of the notoriety for conspicuous effects of Cannabis, and yet there are close

cousins of cannabinoids as well as other classes of compounds that all work synergistically with THC and CBD to

provide the quality of the experience.

For comparison, there can be a “Nutrition Facts” equivalent for botanicals - Cannabis specifically - as depicted

in Figure 1. A partial phytochemical breakdown for Cannabis, (here analyzed by GCMS) is profiled from a research

paper. However, a standard phytochemical profile that could be used to document how growing conditions may

alter secondary plant metabolite expression, and how (specifically) the terpenes affect the biological impact on

the broader human sensory experience has yet been allowed the same importance as nutrition facts for junk

food. For instance, limonene is reputed to “mellow” the psychoactivity of THC, and beta-myrcene may actually

be responsible for the “couch-lock” effect of varieties that are marketed as “indicas”. Pinene may be responsible

for the “head” effect of sativas and linalool for elevating mood. No one has yet to publish any data on these

topics due to the restrictions on formally conducting these studies, and limitations of the current labs to collect

academic-quality data.

Figure 1: A Nutrition Facts label and the GC quantitative data of the strain "white widow"

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The Scientific Basis for a Cannabis Varietal Registry (CVR) The enthusiasm behind our recommendation is rooted in the works of Dr. Arno Hazekamp5 with Dr. Justin

Fischedick6 et al.

In their 2010 study Metabolic fingerprinting of Cannabis sativa L.7, the authors emphasize the “urgency to define

the criteria necessary for the chemotaxonomic classification of medicinal cannabis for drug standardization and

clinical research purposes,” while demonstrating clear qualitative and quantitative chemotaxonomic

differentiation between cannabis varietals using Principal Component Analysis (PCA) – a method of algorithmic

multivariate analysis.

In their 2011 study Cannabis – from cultivar to chemovar8, the authors assert that for “a clearer understanding

of medicinal properties of the Cannabis plant, a better classification system, based on a range of potentially

active constituents, is needed” while again demonstrating the methods of multivariate analysis as clearly useful

in defining variously-sourced cannabis samples into distinct chemovar groups.

What this means:

It means that, provided an adequate sample population, the science supports the development of a classification

system for cannabis based on the metabolic similarities and relationships between varietals. Simply put, we can

fingerprint cannabis strains and categorize them into types based on their constituent makeup. The missing

component has been an adequate sample population of cultivators and varietals, and this is the opportunity

presented to us in I-502.

We assert that it is our responsibility to capture and make freely available - for science and the interests of all

constituents - the new learning to be found in the opportunities presented us that are so unique to these

moments alone.

Figure 2: A PCA scatter diagram illustrating the clustering of cannabis varietals by metabolic similarities

5 Principal Scientist, Bedrocan BV, P.O. Box 2009, 9640CA Veendam, The Netherlands 6 Division of Pharmacognosy, Section Metabolomics, Institute of Biology, Leiden University, Leiden, The Netherlands 7 2010, Metabolic fingerprinting of Cannabis sativa L., cannabinoids and terpenoids for chemotaxonomic and drug standardization purposes. Justin Thomas Fischedick, Arno Hazekamp, Tjalling Erkelens, Young Hae Choi, Rob Verpoorte. 8 Cannabis - from cultivar to chemovar. A. Hazekamp and J. T. Fischedick

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The CVR Will Significantly Inform Commercial Research The exponential advances in cannabis breeding and cultivation practices in the last two decades have resulted

in the introduction of highly differentiated strains as well as the exponential increase in potency of cannabis

products. All of these are contributions of the largely unregulated medical cannabis industry, and have all been

achieved almost entirely without the benefit of science. Breeders and producers have instead relied on logic,

experience and trial-and-error in achieving desired outcomes in both cultivation methods and phenotype

development.

Today – in this period before the advent of producer brands - strain selection and tactile contact remain the

patient’s sole reference points at retail, and the relevance of varietals will anything but diminish in the consumer

market.

This dawn of the commercial cannabis industry will see the advent of commercial cannabis product research

and development of white-market proportions, and the CRV is precisely the data required to inform this

research. Armed with complete metabolic profiles and a knowledge of terpenes and other currently unanalyzed

constituents, commercial research will be optimally informed to achieve desired outcomes.

The Cannabis Varietal Registry will inform:

The development of new, commercially relevant products

Product continuity, year over year (standardization)

The breeding of commercially differentiated strains

The advancement of cultivation practices to specific end

The CVR Will Significantly Inform Medical Research Although Washington State currently has both a medical and a legal regulatory framework, we recognize that

the absorption of medical policy by legal Cannabis policy presents the likelihood that legal cannabis consumers

will make medical use of commercial Cannabis.

Plants are complex mixtures of many classes of phytochemicals – many of which are biologically active. It is

widely assumed that different Cannabis strains (also known as cultivar, varietal or phenotypes) have unique

medical relevance. But to be informed by a twenty-something bud-tender that a certain strain will “improve

memory” and “treat kidney conditions” challenges the guidance of FDA regulation of herbal and dietary

supplements. However, the patient anecdotes have fueled the urban legends regarding strains that are on the

market. Strains labeled by the same name may not have closely similar phytochemical fingerprints, and until we

collect the data, it is unknown how accurate a consumer may reproduce an effect, and how retail spaces can

“frame” varieties, when supplying and dispensing products being called by the same name, but may or may not

have any phytochemical resemblance.

In short, the academic knowledge that can inspire and guide both commercial and medical platforms are NOT

currently sufficient for informing commercial or medical consumption.

A significant milestone would be met with the collection and analysis of quantitative data of the phytochemical

fingerprints of Cannabis varieties across a population of producers.

The CRV richly informs the needs of medical science for:

Pharmaceutical standardization and Quality control

Our understand the effective contribution of active constituents

Determining how strains can be bred for specific therapeutic purpose potential

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The CVR Will Richly Inform Current and Potential Cannabis Consumers Washington voters made consumer safety - in every regard - the highest administrative priority tasked to the

WSLCB. The CVR will make a significant contribution to this Washington State priority.

We assert that this objective cannot be over-informed.

Figure 3: A CVR-enabled labeling scenario: The consumer’s understanding of cannabis is already extensive – as demonstrated in the online conversation - and they will increasingly require access to comprehensive product information

While there may be a dearth of hard science on the topic, that isn’t reflected in the dimensions of the public

conversation. Cannabis strains are the conversational focal-point of a massive on-line interchange of information

and the shared experiences of cannabis users. Taken in aggregate, this represents more than just an enormous

conversation about weed. This in fact is a treasure trove of patient- and consumer- inspired research matter

that has evolved its own taxonomy, based (almost) entirely on the subjective human experience with very little

contribution from science except in the broadest of strokes. So, while the extent of the cannabis taxonomy to

describe strains by type is extremely limited, there are over 700 known strains, and millions of people talking

about them, and beyond this it’s just out of control.

But understand that collectively, this is the consumer and patient conversation, the where and how people gain

and share information on cannabis today, and the conversation is strains, and its relevance to us cannot be

underestimated.

Figure 4: There are many popular online destinations focused on information and conversation about cannabis strains

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Online behaviors exhibit patterns, and there are certain absolutes that can indeed be foreseen, and one of them

is this: If you were to publish a comprehensive and freely-available database of cannabis cultivars as we describe

– even just the raw quantitative chromatography data we’ve shown you - you would ignite a phenomenon at

the intersection of the social/human experience and science/discovery and our goal of the optimally-informed

consumer, defined as consumers with complete access to information to the full extent of their individual

interests. And of course it is commonly accepted that there is an inverse relationship between a consumer’s

knowledge of a product and adverse behaviors exhibited with that product. The very point of these sites is the

dissemination of information on cannabis, and every one of these would instantly tap into your database,

integrate it with their curated social histories, and in a single stroke you would elevate the conversation by a

massive margin – almost without trying. The Wikipedia pages for each of these compounds would light up and

the conversation would leap forward with new learning. That’s not hyperbole; we believe publishing this dataset

is an essential public service and a social responsibility.

This is an example of what we mean, though, when we say this information is important and needs to be made

aggregate and needs to be made free, and an opportunity lost if ignored.

Conclusion For the first time in more than four decades of polling on the issue, the Pew Research Center in April of this year

showed that a majority of Americans favor legalizing the use of marijuana. A tipping point has been reached,

and it is certain that as states move forward with the liberalization of marijuana laws, increasingly they will look

to Washington for regulatory guidance and example.

We believe that our proposal for the Cannabis Varietal Registry, if adopted, will be a clear demonstration of

leadership and visionary example in the formation of an enlightened regulatory framework for commercial

cannabis, and set Washington as an example of authority and wisdom in establishing these goals.

In summary, we propose that the State assign an independent organization that will oversee the formation and

management of a Washington State Cannabis Varietal Registry, from which a database of chemotaxonomic

profiles of all phenotypes taken to market by Washington Growers will be maintained. From this data and that

produced by recurrent crop testing, the state’s assignee will create a cannabis classification system and

methodology, and will make public without fee all work products derived for the benefit of all future research.

The state’s assignee shall provide these services on a non-profit basis, and be maintained by and responsible to

the Washington Cannabis Industry. The assignee shall work in service to the People of Washington, thus that

every example of a given variety bearing the Washington Tax Stamp shall be of the highest possible order, of

uniform genotype and potential, and conformant to the expectations of an optimally-informed consumer.