HomeMy WebLinkAbout06662-1 - THE WERC SHOP MEDICAL CANNABIS TESTING SERVICES PALM Sp
y; City of Palm Springs
David H. Ready, Esq., Ph.D.
* City Manager
3200 East Tahquitz Canyon Way,Palm Springs CA 92262
C4�IF0V9t Tel 760.322.8350 • Fax 760.323.8207 * TDD 760.864,9527
David.Ready@palmspringsca.gov • www.palmspringsca.gov ^� `
April 8, 2015
Via U.S. Mail and Electronic Mail
legal notices@thewereshop.com
The Werc Shop
Medical Cannabis Testing Services "C l
ATTN: Dr. Jeffrey C. Raber
2585 Nina Street
Pasadena, CA 91107
RE: Contract Services Agreement
Notice of Termination
Mr. Raber,
Pursuant to Section 4.5 of the Agreement between the City of Palm Springs and
the Werc Shop dated April 1, 2015, the City hereby terminates the Agreement.
Regretfully,
CITY OF PALM SPRINGS
DAVID H. READY
City Manager
JAMES THOMPSON
Chief of Staff/City Clerk
PO Box 2743,Palm Springs CA 92263
CONSULTING SERVICES AGREEMENT
The Were Shop
Medical Cannabis Testing Services
THIS AGREEMENT FOR CONSULTING SERVICES ("Agreement") is made and
entered into on April 1, 2015, by and between the City of Palm Springs, a California charter city
and municipal corporation ("City"), and The Werc Shop Laboratory, LLC ("Consultant"). City
and Consultant are individually referred to as "Parry" and are collectively referred to as the.
"Parties".
RECITALS
A. City requires the services of a qualified Medical Cannabis Testing consultant to
provide testing and analytical services to be used by City in the enforcement of the City's
Medical Cannabis Collective/Cooperative("MCCC") ordinances and regulations, ("Project").
B. Consultant has submitted to City a proposal to provide Medical Cannabis Testing
services to City under the terms of this Agreement.
C. Based on its experience, education, training, and reputation, Consultant is qualified
and desires to provide the necessary services to City for the Project.
D. City desires to retain the services of Consultant for the Project.
In consideration of these promises and mutual agreements, City and Consultant agree as
follows:
AGREEMENT
1. CONSULTANT SERVICES
1.1 Scope of Services. In compliance with all terms and conditions of this Agreement,
Consultant shall provide testing and analytical services to City as described in the Scope of
Services/Work attached to this Agreement as Exhibit "A" and incorporated by reference (the
"services" or "work"). Exhibit "A" includes the agreed upon schedule of testing performance and
the schedule of fees. Consultant warrants that all testing services and work shall be performed in
a competent and professional manner consistent with prevailing industry standards. In the event
of any inconsistency between the terms contained in the Scope of Services/Work and the terms
set forth in this Agreement, the terms set forth in this Agreement shall govern.
1.2 Compliance with Law. Consultant testing services rendered under this Agreement
shall comply with all applicable California state and local laws, statutes, and ordinances and all
lawful orders, rules, and regulations of the State of California and City.
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1.3 Licenses and Permits. Consultant shall obtain at its sole cost and expense such
licenses, permits, and approvals as may be required by California state and local law for the
performance of the testing services required by this Agreement.
1.4 Familiarity with Work. By executing this Agreement, Consultant warrants that it
has carefully considered how the work should be performed and fully-understands the facilities,
difficulties, and restrictions attending performance of the work under this Agreement.
1.5 Contract Officer. The Contract Officer shall be the City Manager or his/her
designee ("Contract Officer"). Consultant shall be responsible for keeping the Contract Officer
fully informed of the progress of the performance of the services. Consultant shall refer any
decisions that must be made by City to the Contract Officer. Unless otherwise specified, any
approval of City shall mean the approval of the Contract Officer.
2. TIME FOR COMPLETION
The time for completion of the testing services to be performed by Consultant is an
essential condition of this Agreement. Consultant shall prosecute regularly and diligently the
work of this Agreement according to the agreed upon schedule of performance set forth in
Exhibit "A." Consultant shall not be accountable for delays in the progress of its work caused by
any condition beyond its control and without the fault or negligence of Consultant. Delays shall
not entitle Consultant to any additional compensation regardless of the party responsible for the
delay.
3. COMPENSATION OF CONSULTANT
3.1 Compensation of Consultant. Consultant shall be compensated and reimbursed for
the services rendered under this Agreement in accordance with the schedule of fees set forth in
Exhibit"A". The total amount of Compensation shall not exceed $25,000.
3.2 Method of Payment. Consultant shall submit to Contract Officer an invoice for
services rendered on a monthly basis in the form reasonably approved by City's finance director.
Failure to submit an invoice for any month shall not constitute a waiver by Consultant to present
an invoice for such month. Payments shall be based on the rates set forth in Exhibit "A" for
authorized services performed. City shall pay Consultant for all expenses stated in the invoice
that are approved by Contract Officer and consistent with this Agreement. City shall pay invoices
within thirty (30) days of receipt of Consultant's invoice.
3.3 Changes. In the event any change or changes in the Scope of Services/Work is
desired by City, City shall submit a written proposal to Consultant, and the Parties shall negotiate
in good faith a written amendment to this Agreement, specifying all proposed amendments,
including,but not limited to, any additional fees. An amendment may be entered into:
A. To provide for revisions or modifications to documents, work product, or
work, when required by the enactment or revision of any subsequent law; or
B. To provide for additional services not included in this Agreement or not
customarily furnished in accordance with generally accepted practice in Consultant's profession.
An amendment to this Agreement shall only be effective if in writing and signed by both parties.
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4. PERFORMANCE SCHEDULE
4.1 Time of Essence. Time is of the essence in the performance of this Agreement.
4.2 Schedule of Performance. All services rendered under this Agreement shall be
performed under the agreed upon schedule of performance set forth in Exhibit "A." Any time
period extension must be approved in writing by the Contract Officer.
4.3 Force Majeure. The time for performance of services to be rendered by Consultant
under this Agreement may be extended because of any delays due to unforeseeable causes beyond
the control and without the fault or negligence of Consultant, if Consultant notifies the Contract
Officer within ten (10) days of the commencement of such condition. Unforeseeable causes
include, but are not limited to, acts of God or of a public enemy, acts of the government, fires,
earthquakes, floods, epidemic, quarantine restrictions, riots, strikes, freight embargoes, and
unusually severe weather. After Consultant notification, the Contract Officer shall investigate the
facts and the extent of any necessary delay, and extend the time for performing the services for
the period of the enforced delay when and if, in the Contract Officer's judgment, such delay is
justified. The Contract Officer's determination shall be final and conclusive upon the parties to
this Agreement.
4.4 Term. Unless earlier terminated in accordance with Section 4.5 of this Agreement,
this Agreement shall continue in full force and effect for a period of one (1) year, commencing on
April 1, 2015, and ending on March 31, 2016, unless extended by mutual written agreement of
the parties.
4.5 Termination Prior to Expiration of Term. Contract Officer may terminate this
Agreement at any time, with or without cause, upon thirty (30) days written notice to Consultant.
Where termination is due to the fault of Consultant and constitutes an immediate danger to health,
safety, and general welfare, the period of notice shall be such shorter time as may be determined
by the City. Upon receipt of the notice of termination, Consultant shall immediately cease all
services except such as may be specifically approved by the Contract Officer. Consultant shall be
entitled to compensation for all services rendered prior to receipt of the notice of termination and
for any services authorized by the Contract Officer after such notice. Consultant may terminate
this Agreement, with or without cause, upon thirty (30) days written notice to Contract Officer.
5. COORDINATION OF WORK
5.1 Representative of Consultant. The following principal of Consultant is designated
as being the principal and representative of Consultant authorized to act and make all decisions in
its behalf with respect to the specified services and work: Jeffrey C. Raber, Ph.D, CEO. It is
expressly understood that the experience, knowledge, education, capability, and reputation of the
foregoing principal is a substantial inducement for City to enter into this Agreement. Therefore,
the foregoing principal shall be responsible during the term of this Agreement devoting sufficient
time to personally supervise the services under this Agreement. The foregoing principal may not
be changed by Consultant without prior written approval of the Contract Officer.
5.2 Prohibition Against Subcontracting or Assignment. The experience,knowledge,
education, capability, and reputation of Consultant, its principals and employees, were a
substantial inducement for City to enter into this Agreement. Therefore, Consultant shall not
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contract with any other individual or entity to perform any services required under this
Agreement without the City's express written approval. In addition, neither this Agreement nor
any interest may be assigned or transferred, voluntarily or by operation of law, without the prior
written approval of City.
5.3 Indenendent Contractor. Neither City nor any of its employees shall have any
control over the manner, mode, or means by which Consultant, its agents or employees, perform
the services required, except as otherwise specified. Consultant shall perform all required
services as an independent contractor of City and shall not be an employee of City and shall
remain at all times as to City a wholly independent contractor with only such obligations as are
consistent with that role; however, City shall have the right to review Consultant's work product,
result, and advice. Consultant shall not at any time or in any manner represent that it or any of its
agents or employees are agents or employees of City.
5.4 Personnel. Consultant agrees to assign the following individuals to supervise the
services in this Agreement. Consultant shall not alter the assignment of the following personnel
without the prior written approval of the Contract Officer. Acting through the Contract Officer,
the City shall have the unrestricted right to order the removal of any personnel assigned by
Consultant by providing written notice to Consultant.
Name: Title:
Dr. Jeffrey C. Raber Founder& CEO
5.5 Cooperation. City understands that Consultant will be required to pick up,
transport and test samples of cannabis in order to perform the services under this Agreement.
City shall cooperate and assist Consultant as reasonably necessary in order for Consultant to
provide the services under this Agreement. Such cooperation and assistance will include, without
limitation, requesting assistance from law enforcement and governmental agencies.
6. INSURANCE
Consultant shall procure and maintain, at its sole cost and expense, policies of insurance
as set forth in the attached Exhibit "B", incorporated herein by reference.
7. INDEMNIFICATION.
7.1 Indemnification. To the fullest extent permitted by law, Consultant shall defend
(at Consultant's sole cost and expense), indemnify, protect, and hold harmless City, its elected
officials, officers, employees, agents, and volunteers (collectively the "Indemnified Parties"),
from and against any and all liabilities, actions, suits, claims, demands, losses, costs,judgments,
arbitration awards, settlements, damages, demands, orders, penalties, and expenses including
legal costs and attorney fees (collectively "Claims") for damage to property, including property
owned by City, from any violation of any state, or local law or ordinance by Consultant, and from
errors and omissions arising from gross negligence or willful misconduct by Consultant, its
officers, employees, representatives, and agents, in either case that arise out of or relate to
Consultant's performance under this Agreement. This indemnification clause excludes Claims
arising from the sole negligence or willful misconduct of the City, its elected officials, officers,
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employees, agents, and volunteers. Under no circumstances shall the insurance requirements and
limits set forth in this Agreement be construed to limit Consultant's indemnification obligation or
other liability under this Agreement. Consultant's indemnification obligation shall survive the
expiration or earlier termination of this Agreement until all actions against the Indemnified
Parties for such matters indemnified are fully and finally barred by the applicable statute of
limitations or, if an action is timely filed, until such action is final. This provision is intended for
the benefit of third party Indemnified Parties not otherwise a party to this Agreement. As used in
this Agreement, "willful misconduct" shall not include any action or inaction in violation of
Federal laws.
7.2 Liability/Damages Limitation. Notwithstanding anything to the contrary in this
Agreement, Consultant will not be liable to City, any beneficiary of this Agreement, or any other
person or entity for, or otherwise obligated to pay, (a) any consequential, punitive, or lost profits;
(b) any loss suffered by reason of any services rendered by Consultant or other action taken or
omitted in good faith by Consultant and/or Consultant's agents; (c) any loss arising from
Consultant's adherence to City's written or oral instructions; and (d) any act or failure to act by
any contractor or agent of Consultant or any other person or entity to which Consultant directs
transactions for City. Notwithstanding anything to the contrary in this Agreement, except as
provided in Section 7.1 of this Agreement, in no event will Consultant's aggregate liability to
City, any beneficiary of this Agreement, and/or any other person or entity, collectively, exceed
the amount paid by City pursuant to this Agreement and received by Consultant during the twelve
month period ended on the date on which the events giving rise to such liability first occurred.
EXCEPT FOR THE WARRANTY SET FORTH IN SECTION 1.1, CONSULTANT
EXPRESSLY DISCLAIMS, ANY AND ALL REPRESENTATIONS AND WARRANTIES,
WRITTEN OR ORAL, STATUTORY OR CONTRACTUAL, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, THE WARRANTY OF MERCHANTABILITY,
INFRINGEMENT, COMPLETENESS, QUALITY OR FITNESS FOR A PARTICULAR
PURPOSE OR USE.
8. RECORDS AND RFPORTS
8.1 Reports. Consultant shall periodically prepare and submit to the Contract Officer
reports concerning the performance of the services required by this Agreement, or as the Contract
Officer shall reasonably require.
8.2 Records. Consultant shall keep complete, accurate, and detailed accounts of all
time, costs, expenses, and expenditures pertaining in any way to this Agreement as shall be
necessary to properly perform the services required by this Agreement and enable the Contract
Officer to evaluate the performance of such services ("Records"). Consultant shall provide the
Contract Officer with access to Records reasonably necessary for City to confirm Consultant's
charges for services under this Agreement following Contract Officer's written request.
8.3 Ownership of Documents. All test results prepared by Consultant in the
performance of this Agreement shall be the property of Consultant and City. Consultant shall
deliver all above-referenced documents to City upon request of the Contract Officer. Consultant
shall have no claim for further employment or additional compensation as a result of the exercise
by City of its rights or ownership of the documents and materials. Consultant may retain copies
of such documents for Consultant's own use. Consultant shall have an unrestricted right to use
the concepts embodied in such documents.
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8.4 Release of Documents. All test results prepared by Consultant in the
performance of services under this Agreement shall not be released publicly without the prior
written approval of the Contract Officer.
8.5 Cost Records. Consultant shall maintain all books, documents, papers, employee
time sheets, accounting records, and other evidence pertaining to reimbursable expenses incurred
while performing under this Agreement. Consultant shall make copies of such materials
available to City during the term of this Agreement and for one (1) year from the date of final
payment.
8.6 Secure Transactions. Consultant has implemented and will maintain reasonable
security systems for the transmission and possession of the City's information and documentation,
in hard or electronic format, consistent with appropriate and reasonable industry standards for the
transmission and possession of such information, including without limitation transmission of
the Internet or stored on systems maintained b
such information or documentation over y y
Consultant.
8.7 Non-Disclosure. Consultant acknowledges that in the performance of services
under this Contract, Consultant may have access to nonpublic and/or confidential information
pertaining to the City and its operations. Consultant agrees to maintain the confidentially of such
information, and will: (i) use the confidential information solely for the purposes set forth in this
Contract; (ii) take suitable precautions and measure to maintain the confidentiality of the
confidential information of the City; and (iii) not disclose or otherwise fumish the confidential
information to any third party.
9. ENFORCEMENT OF AGREEMENT
9.1 California Law. This Agreement shall be construed and interpreted both as to
validity and to performance of the parties in accordance with the laws of the State of California.
Legal actions concerning any dispute, claim, or matter arising out of or in relation to this
Agreement shall be instituted in the Superior Court of the County of Riverside, State of
California, or any other appropriate court in such county, and both Parties covenant and agree to
submit to the personal jurisdiction of such court in the event of such action.
9.2 Internretation. This Agreement shall be construed as a whole according to its fair
language and common meaning to achieve the objectives and purposes of the Parties. The terms
of this Agreement are contractual and the result of negotiation between the Parties. Accordingly,
any rule of construction of contracts (including, without limitation, California Civil Code Section
1654) that ambiguities are to be construed against the drafting party, shall not be employed in the
interpretation of this Agreement. The caption headings of the various sections and paragraphs of
this Agreement are for convenience and identification purposes only and shall not be deemed to
limit, expand, or define the contents of the respective sections or paragraphs.
9.3 Waiver. No delay or omission in the exercise of any right or remedy of a non-
defaulting party on any default shall impair such right or remedy or be construed as a waiver. No
consent or approval of either Party shall be deemed to waive or render unnecessary such Party's
consent to or approval of any subsequent act of the other Party. Any waiver by either Party of
any default must be in writing. No such waiver shall be a waiver of any other default concerning
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the same or any other provision of this Agreement.
9.4 Riehts and Remedies are Cumulative. Except with respect to rights and remedies
expressly declared to be exclusive in this Agreement, the rights and remedies of the Parties are
cumulative. The exercise by either Party of one or more of such rights or remedies shall not
preclude the exercise by it, at the same or different times, of any other rights or remedies for the
same default or any other default by the other Party.
9.5 Legal Action. In addition to any other rights or remedies, either Party may take
legal action, in law or in equity, to cure, correct, or remedy any default, to recover damages for
any default, to compel specific performance of this Agreement, to seek injunctive relief, a
declaratory judgment, or any other remedy consistent with the purposes of this Agreement.
10. CITY OFFICERS AND EMPLOYEES: NON-DISCRIMINATION
10.1 Non-Liability of Officers and Employees. No officer or employee of either Party
shall be personally liable to the other Party, or any successor-in-interest, in the event of any
default or breach by such Party or for any amount which may become due to the other Party or its
successor, or for breach of any obligation of the terms of this Agreement.
10.2 Conflict of Interest. No officer or employee of the City shall have any direct or
indirect financial interest in this Agreement nor shall any such officer or employee participate in
any decision relating to the Agreement which effects their financial interest or the financial
interest of any corporation, partnership, or association in which he/she is, directly or indirectly,
interested in violation of any state statute or regulation. Consultant warrants that Consultant has
not paid or given, and will not pay or give, any third party any money or other consideration in
exchange for obtaining this Agreement.
10.3 Covenant Against Discrimination. Consultant covenants that, by and for itself, its
heirs, executors, assigns, and all persons claiming under or through them, that there shall be no
discrimination or segregation in the performance of or in connection with this Agreement
regarding any person or group of persons on account of race, color, creed, religion, sex, marital
status, disability, sexual orientation, national origin, or ancestry.
11. MISCEL.L.ANEOUS PROVISIONS
11.1 Notice. Any notice, demand, request, consent, approval, or communication that
either party desires, or is required to give to the other party or any other person shall be in writing
and either served personally or sent by pre-paid, first-class mail to the address set forth below.
Notice shall be deemed communicated seventy-two (72) hours from the time of mailing if mailed
as provided in this Section. Either party may change its address by notifying the other parry of
the change of address in writing.
To City: City of Palm Springs
Attention: City Manager/City Clerk
3200 E. Tahquitz Canyon Way
Palm Springs, California 92262
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To Consultant: The Were Shop
Medical Cannabis Testing Services
Attention: Dr. Jeffrey C. Raber
E-mail: leealnoticesaa,thewereshon.com
11.2 Integrated Agreement. This Agreement contains all of the agreements of the
parties and supersedes all other written agreements.
11.3 Amendment. No amendments or other modifications of this Agreement shall be
binding unless through written agreement by all Parties.
11.4 Severability. Whenever possible, each provision of this Agreement shall be
interpreted in such a manner as to be effective and valid under applicable law. In the event that
any one or more of the phrases, sentences, clauses, paragraphs, or sections contained in this
Agreement shall be declared invalid or unenforceable by valid judgment or decree of a court of
competent jurisdiction, such invalidity or unenforceability shall not affect any of the remaining
phrases, sentences, clauses, paragraphs, or sections of this Agreement, which shall be interpreted
to carry out the intent of the parties.
11.5 Successors in Interest. This Agreement shall be binding upon and inure to the
benefit of the Parties' successors and assignees.
11.6 Third Party Beneficiary. Except as may be expressly provided for in this
Agreement, nothing contained in this Agreement is intended to confer, nor shall this Agreement
be construed as conferring, any rights, including, without limitation, any rights as a third-party
beneficiary or otherwise, upon any entity or person not a party to this Agreement.
11.7 Recitals. The above-referenced Recitals are hereby incorporated into the
Agreement as though fully set forth in this Agreement and each Party acknowledges and agrees
that such Party is bound, for purposes of this Agreement, by the same.
11.8 Authority. The persons executing this Agreement on behalf of the Parties warrant
that they are duly authorized to execute this Agreement on behalf of Parties and that by so
executing this Agreement the Parties are formally bound to the provisions of this Agreement.
11.9 Collective Membership. City acknowledges that certain designated employees,
officers, or agents of the Consultant will be required to become members of medical cannabis
collectives in the City of Palm Springs, in order to be in lawful possession of medical cannabis
pursuant to California law. Consultant will provide and maintain a current list of such
employees, officers, or agents, and the collectives for which such persons are members of to the
City Manager upon request by City Manager.
11.10 Conflict of interest. Consultant shall not perform any independent testing to any
permitted medical cannabis collective in the City of Palm Springs, without the express written
consent of the City Manager. Employees, officers, and agents of Consultant shall not accept
gifts, honoraria, travel and loans from any permitted medical cannabis collective in the City of
Palm Springs.
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11.11 Non-Exclusive Agreement. Consultant acknowledges and agrees that this
Agreement to provide medical cannabis testing services as set forth herein is non-exclusive. City
at its sole discretion may contract with other medical cannabis testing providers, as it deems
necessary and appropriate.
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IN WITNESS WHEREOF,the Parties have executed this Agreement as of the dates
stated below.
"CITY"
City of Palm Springs
Date: �o: / �"' By: ✓rj��
David H.
APPROVED BY CITY MANAGER Ready, Cit
Manager
aba�z r1TEyZS,eoU
APPROVED AS TO FORM: ATTEST
By: "`„`— By-
Douglas C. Holland, es Thompson,
City Attorney City Clerk
"CONSULTANT"
The Were Shop Laboratory,LLC
Date: 31�8117 By :
Dr. Jeffrey C. Raber, CEO
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EXHIBIT "A"
CONSULTANT'S
SCOPE OF TESTING SERVICES/WORK
Including,
Schedule of Fees
And
Schedule of Performance
SCOPE OF SERVICES
Consultant shall perform medical cannabis testing services, per the attached proposal.
The proposal provides for of a carte pricing objectives.
The City currently has four permitted medical cannabis collectives. Three are
operational and the fourth is in processes. The initial testing frequency requested by the
City is as follows, and may be modified by the City in writing.
Pick-up, testing, reporting, and label generation at three permitted collectives (adding the
forth collective when operational):
Testing (4 test total): Cannabinoid, Terpene, Pesticide, Microbio.
Number of Samples: 10 sample per collective.
Frequency: Every two weeks. Cost: $160 per sample for all four tests. If the City
requests less than all 4 tests, each individual test ordered will cost $40.
Consultant will charge an hourly rate of $125 for personnel to travel to and attend
meetings, seminars and other functions as requested by the City. Time will be charged in
increments of one-tenth of an hour. Travel time to collect samples is included in the
testing fees and will not be billed.
Consultant shall determine the order for which samples to collect, implementing a
rotation so that all products are eventually tested.
Consultant shall perform a cursory visual inspection of each collective at the time of
sample pick-up for compliance with the Sanitary Regulations in Chapter 5.35 of the Palm
Springs Municipal Code. Consultant shall notify the City of any potential violations or of
un-sanitary conditions observed by Consultant at any permitted collective.
Consultant shall attend meetings with City Staff and/or Collective Representatives of
mission, objectives, and updates of the testing programs.
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TheWerc ShopMedical Cannabis Testing
Services
`Moving sustainable Medicines Forward" A PROPOSAL TO THE CITY OF PALM SPRINGS
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The erc Shop
Moving Sustainable Medicines Forward
Section 1. Background, Firm and Staff Qualifications
Background
Based in Pasadena California, The Were Shop Laboratory, LLC is an independent analytical
laboratory that has offered medical cannabis testing services in California for the last 4.5 years.
Dr. Jeffrey C. Raber, The Werc Shop's founder, CEO and CVO, received his Ph.D. in Chemistry
from the University of Southern California with a focus on developing new synthetic
methodologies. Driven by a desire to make a positive contribution to society while creating
American jobs, in 2010 Dr. Raber with his brother and co-founder Mark Raber founded The Werc
Shop, an independent laboratory focused on botanical analysis and sustainability with an initial
emphasis on serving public health and safety needs within the medical cannabis community. Dr.
Raber's background as an accomplished scientist, patented inventor and seasoned executive
provide him with a unique perspective and skill set useful in assisting state and local regulators in
the construction and implementation of effective solutions for safely providing medical cannabis
products to qualified patients.
The Were Shop is well respected as a professional, exceptionally competent, scientific service
provider with commercially offered services that include cannabinoid quantification, mold and
microbiological analysis, pesticide and other chemical residue screening, and extensive terpene
profiling. Advanced analytical methods, chemotype classification abilities and informative
labeling are some of the products and services developed by the team of Ph.D. and MS scientists
employed by The Werc Shop. The Werc Shop's cannabis expertise stems from a love of science,
a vast and rich technical knowledge base, and a strong commitment to protecting the health of
cannabis consumers. Expertise in the regulatory compliance with new dietary supplements,
analytical method development for pharmaceutical toxicology screening programs, chemical
process developments and scale-up methods for fine chemicals and natural products coupled to a
diverse and creative perspective towards problem solving enables The Werc Shop to offer
unparalleled services at a very technical level.
Ensuring consumer safety begins with a detailed chemical understanding of the particular botanical
product of interest. The Werc Shop has developed advanced methods to characterize products
derived from cannabis in order to assure they are produced accurately and reproducibly. The
foundation for this expertise begins with strong analytical testing competency, which The Werc
Shop possesses and excels at more so than any other service laboratory operating with cannabis in
the United States today. Our scientific expertise was exhibited when our first peer-reviewed
publication was highlighted by Sanja Gupta in his television show "Weed 2". Additionally, we
frequently receive invites to lecture at international scientific conferences describing our methods
of cannabis analysis. We are also fortunate to have a particular scientist on the team that is a Dutch
national who was instrumental in the development of their national medical cannabis program's
quality control and product release standards possessing almost 8 years of detailed cannabis
operational expertise in a federally regulated national program.
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The erc Shop
Moving Sustainable Medicines Forward'
The Were Shop's experience in the California medical market has offered the ability to inspect,
analyze and consult on a plethora of infused product types including but not limited to, brownies,
cookies, cakes, breads, capsules, smoothies, drinks, popcorn, gummy candies, topical ointments,
tinctures, hard candies, chocolate bars, and even ice cream. We are consistently recognized by
many product providers as the most competent scientists in the field, always capable of properly
analyzing any type of infused product sent our way. Recommending doctors also trust us to be the
accurate and informed scientists capable of verifying and discussing the contents of medicine
intended for children and immunocompromised patient populations.
The complexity of cannabis, often called the entourage effect, is what makes it so powerful in
healing so many unique ailments and physiological imbalances. The key components that aid
cannabinoids providing each unique entourage effect are what chemists call terpenes. In 2011 The
Were Shop was the first laboratory to offer terpene profiling of cannabis looking at over 35
different terpenes. Having over 3 years of experience with this broad based profiling method in
the wildly diverse market of California offers a unique and extraordinarily detailed understanding
of cannabis cultivars and the product landscape within current medical cannabis markets. Detailed
analysis of this collective data has been used to demonstrate a distinct difference between cannabis
cultivars by name and morphological(indica and sativa)type and is useful in identifying misnamed
and misidentified cannabis products. More than 30%of a particular cannabis variety with a popular
cultural history, named Jack Herer, was shown to in fact not contain a chemical profile similar to
the rest of the varieties selected under the same name across dispensaries in California. This level
of understanding can be mapped to patient effectiveness and ultimately provide an individualized
level of patient formulation helping to realize more of the full potential of cannabis.
When providing medicinal products, especially ones derived from cannabis,the more detailed the
understanding of the product the more it can be replicated consistently and the more it is a useful
medicinal product. The Were Shop possesses uniquely informed insights and relevant experience
with cannabis having analyzed over 15,000 different samples. US Lawmakers, state regulators,
numerous medical doctors, academic researchers around the world and countless patients have
learned more about cannabis and its potential medical applications from the cannabis expertise
possessed by The Were Shop.
As professional scientists with advanced chemistry degrees (2 University of Southern California
PhD's work in our Pasadena offices) we are recognized by many as scientific leaders and are
respected for our depth of knowledge and innovative analysis efforts with cannabis. Our
comprehensive cannabis testing program covers over 45 different cannabinoids and terpenes,
detection of 30 different pesticides and hundreds of microbiological contaminants. We have
processed thousands of unique samples and benefit from vast cannabis and botanical analytical
expertise retained by professional scientists.
We are more than capable of doing the testing your contract requires and are professional business
operators and service providers that take great pride in running an efficient and effective
organization.
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The Wrc Shop
Moving Sustainable Medicines Forward"
Contact.
Dr. Jeffrey C. Raber
Founder, CEO& CVO
jeff(athewereshop.com
1-855-665-9993
Staff Qualifications. (Full CVs included in Exhibit A)
Jeffrey C. Raber, Ph.D.
Dr. Raber is a serial entrepreneur with a thirst for knowledge and an ability to envision new
technologies and the brighter future they can help build. Dr. Raber was also an early mover in
the internet service provider market when he helped found a local provider in 1995 while
working towards his B.S. in Biochemistry from Lebanon Valley College. Dr. Raber studied plant
phylogenetics of the RuBisCO enzyme while at LVC and was named to the USA Today 1997
All-USA College Academic Team for his research accomplishments in this area. Dr. Raber
graduated from LVC and decided to move from his hometown in Pennsylvania and expand his
opportunities by attending graduate school in Los Angeles, CA at the University of Southern
California.
Dr. Raber completed his degree at USC in less than 5 years and was awarded the Harold and
Lillian Moulton Fellowship. Upon receipt of his degree from USC Dr. Raber was asked to join a
start-up company as the Director of Product Development where he created new molecular
scaffolds for use as starting points in the investigation of new pharmaceuticals by medicinal
chemists and successfully transferred proprietary reaction methodology and know-how to a
production partner.
Having recognized a tremendous need for quality control and assurance in California's Medical
Cannabis arena,Dr. Raber formulated a concept for an analytical testing laboratory that provided
services to the Medical Cannabis arena. After reviewing a massive amount of information and
peer reviewed scientific publications relating to the beneficial impacts of cannabinoid receptor
medications he envisioned the means for furthering everyone's understanding and fundamental
knowledge of the sustainable medication provided through the use of Cannabis sativa L. derived
products. Considering the incredible support he received for the concept and the vast number of
individuals and institutions in need of this type of information, Dr. Raber, despite the inherent
risk personally and professionally, decided to found The Were Shop in an effort to make our
world and homeland a better, greener place.
3
The erc Shop
Moving Sustainable Medicines Forward"
Sytze Elzinga
Mr. Elzinga received his bachelor's degree in biochemistry and subsequently went on to
complete his Masters of Science in Natural Product Chemistry from Leiden University in The
Netherlands in 2006. Mr. Elzinga's early research work involved investigations of Artemisinin
and sesquiterpene precursors found in dead and green leaves of Artemisia annua L. Additional
work involved investigation of the origin of licorice through the use of nuclear magnetic
resonance spectroscopy. Following the completion of his master's thesis Mr. Elzinga moved on
to Farmalyse, a pharmaceutical contract laboratory which performs the quality control and
release of pharmaceutical products. Farmalyse possesses the sole contract with the Dutch
government for the quality control of their medicinal cannabis provided on prescription through
the pharmacies in their national medical marijuana program. At Farmalyse Mr. Elzinga was
responsible for the quality control of all medicinal cannabis for the Dutch pharmaceutical
market.
Mr. Elzinga's experience is invaluable and simply can't be duplicated. No other laboratory in
the United States can boast such experience and expertise pertaining to the proper analysis and
quality control of medicinal cannabis. Currently at The Were Shop, Mr. Elzinga continues to
push the frontier of scientific understanding of medicinal cannabis.
Raquel Keledjian, Ph.D.
Dr. Keledjian serves as the Laboratory Manager for The Were Shop's testing laboratory and
oversees all marijuana testing and laboratory personnel. Dr. Keledjian is an accomplished
scientist who received her Ph.D. in Organic Chemistry from the University of Southern
California in 2003. Dr. Keledjian is a scientist with numerous years of training in organic,
analytical chemistry,and analytical method development. Since joining The Were Shop in 2014
shehas analyzed almost 5,000 different marijuana samples of all different varieties, from dried
marijuana flowers, marijuana concentrates and a large diverse array of marijuana infused edibles.
Building off of the years of pioneering work performed by Dr. Raber and Mr. Elzinga, Dr.
Keledjian is helping The Were Shop further refine our testing approaches and protocols while
always staying focused on safety, good laboratory practices and efficient productivity.
References
We have worked with the below individuals for a number of years, some since our inception and
initial service offerings. Over the course of our efforts in CA we have worked with almost 700
different clients.
David Caspino
Reseda Discount Caregivers
818-307-6723
4
The erc Shop
Moving Sustainable Medicines Forward"
Liz Clarke
Golden State Cooperative
661-321-0900
Lonnie Painter
Laguna Woods for Medicinal Cannabis
949-533-7947
Abraham Robbin
Inland Valley Therapeutic Health Center
909-917-1911
Kenny Morrison
Venice Cookie Company
424-456-7661
SECTION 2. Testing Methodology and Services.
All the right equipment and people don't matter if you don't analyze the proper sample.
Sampling is critical to accuracy in representing a product batch. We chose to pick our own
samples so that a representative sample is collected, not one hand-selected or cherry picked by a
wanting cultivator or product producer aiming for a specific value or passing test. Before Inland
Valley Therapeutic Center closed its doors recently, we were driving virtually every week to the
Palm Springs area. We're certainly capable and willing to perform sample collection and
transportation for the 4 dispensing collectives in your city. We would be able to select the
samples from all four dispensaries in one pick-up, driving out and back to our lab in Pasadena,
CA in one day.
Initially a representative sample is selected from the batch. Batches can be 1-5lbs of flower
material for example,or an edible product all produced in one process at the same time, whereby
we select many different, small and random pieces of flower material by aseptic techniques,
ensuring we provide no chance for contamination by our efforts, ultimately placing the sample in
a sterile sampling bag. The sampling bag is sealed, labeled clearly with name of sample, date of
selection and client name, and transported back to the laboratory in a locked container in the
trunk of the car including transportation paperwork. Infused product samples are typically one or
more units of the edible or topical dependent upon the number of containers available in the
batch. We always aim for statistically viable sampling results while keeping the costs to a
minimum. We sign the sampling paperwork, the client's representative at the dispensary signs
our paperwork and the laboratory logs them in to the queue upon entering the laboratory
ensuring a clean chain of custody where the sample is tracked throughout testing until reporting.
Most often the majority of the sample is destroyed in the testing process. Any remaining material
is treated quickly like a sample and the solution is placed in liquid chemical waste and the solids
(bulk plant material)are placed in our solid waste container for pick-up and disposal by a
chemical waste contractor.
5
The erc Shop
Moving Sustainable Medicines Forward'
We take minimal amounts of sample material to keep economic impacts to a minimum. Our first
goal is analytical and scientific accuracy,the next goal is cost effectively doing the first goal. For
full analysis, including potency, microbiological and pesticide tests,we require 2.2g of flower,
1.5g of concentrate, 1 bottle of tincture and at least 15g of topical cream and 1-3 edible units.
Potency testing is performed with liquid chromatography. This assures the broadest capabilities
in terms of analysis of sample types, and furthermore assures we observe both the cannabinoid
acids and neutral cannabinoids, THCA and THC respectively for example. Terpene testing is
performed using gas chromatography with flame ionization detection. Pesticide testing is
performed using gas chromatography coupled to mass-spectrometry detection. Microbiological
testing is performed using the BioLumix rapid culturing platform capable of performing mold
tests in 48 hours. Typical turn-around times for all tests to be completed are around 4 days.
CANNABINOID PROFILING SERVICES
Cannabinoid profiling enables a patient to determine their accurate dosage and desired chemical
ratios for some of the key components found in medicinal cannabis. By determining what
weight percent of each component is best for a particular patient,the desired medicinal relief can
be achieved more effectively as opposed to just considering the strain name. A key indicator of
the potential effects provided by a particular strain is the THC/CBD ratio. CBD is known to
modulate the effects of THC and typically leads to a more calming and overall smooth response
with less potential for rapid heart rates and other discomfort sometimes garnered from too much
THC alone. Knowing the weight percentage of the cannabinoids can help patients determine
more accurately how much material is best for each individual's preferred dose and will
ultimately lead to a more physiologically effective and cost effective use of the medicine.
CANNABINCIDS SCREENED:
CANNABLVOID PROFILING SERVICE
THCA—A9-Tetrahydrocannabinolic acid A
® , THCA was identified recently as a highly valuable anti-inflammatory agent. This
chemical is only available when consumed orally and the plant has not been heated
before consumption.
6
The erc Shop
Moving Sustainable Medicines Forward"
CBDA—Cannabidiolic acid
® CBDA was identified recently as a highly potent anti-inflammatory agent. This
chemical is only available when consumed orally and the plant has not been heated
before consumption.
CBD—Cannabidiol
® CBD has been shown to provide anti-convulsant, anti-arthritic and neuroprotective
properties while not inducing any psychoactivity. CBD modulates the effects of
THC to provide a non-psychoactive treatment alternative.
THC—A9-Tetrahydrocannabinol
THC has been shown to provide relief for neuropathic pain, stimulates appetite and
® reduces vomiting associated with chemotherapy. THC can be useful to reduce
inflammation and also offers neuroprotective effects. Patients should note THC can
induce psychoactive, or cerebral, effects as well. Too much THC can cause unease,
anxiety and overall discomfort.
7
The erc Shop
Moving Sustainable Medicines Forward"
CBN—Cannabinol
® � CBN is a degradative product of THC.
TERPENE PROFILING SERVICES
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The Well Shop was the first laboratory to begin profiling terpenes within medicinal cannabis in
the summer of 2011. We remain the leaders in this dynamic new frontier of understanding by
screening for many different terpenes using advanced gas-chromatographic techniques. Unlike
most other labs,we don't just do something to say we're doing it or to copy other's efforts, we
do things for a solid scientific reason. We decided to embark on screening for terpenes as they
are critical to understanding which strain is actually which strain, and they are ultimately
responsible for delivering the complex effects provided by whole plant medicinal cannabis
products.Any patient who has attempted to utilize only THC or CBD to determine their optimal
medicine will quickly be able to tell you that comparing only THC values will not help you
identify which strain is best for them. Cannabis is far more complex than only one, or two,
cannabinoids delivering the therapeutic effect. Terpenes modify and modulate the effects of THC
and other cannabinoids and impact the overall medicinal properties of the particular cultivar.
Terpenes are also predominant players in the smell and taste of medicinal cannabis.
8
The erc Shop
Moving Sustainable Medicines Forward"
Terpenes share a common precursor with phytocannabinoids and they are quite potent on their
own, being known to affect animal and even human behavior when inhaled from ambient air at
serum levels in the single digit ng/mL range. Simply put, it doesn't take much of them to make a
physiological impact! Terpenes display unique therapeutic effects that may contribute to the
overall effects of medicinal cannabis; a reason whole based medicines are superior to single-
molecule cannabinoid therapies like Marinol®or other synthetics like Rimonabant. The synergy
of terpenes and cannabinoids are most likely responsible for providing the effective treatment of
pain, anxiety, epilepsy, inflammation, depression, cancer, fungal and bacterial infections,
including methicillin-resistant Staphylococcus aureus. Terpenes are the components responsible
for the plethora of powerful medicinal benefits delivered by cannabis.
A recent publication by Ethan Russo of GW Pharmaceuticals in the British Journal of
Pharmacology(http://10.11 I I/i.1476-5381.2011.01238.x)describes this effect, which is now
being termed the entourage effect. For medicinal cannabis patients to receive the proper
medication, finding the right strain/product required to meet their medical needs,they will need
to understand the terpene content and seek to harness the complete entourage effect being
delivered by their particular strain selection. In the case of medicinal cannabis, more information
is definitely better than less!
A particular cultivator discovered this important differentiation. Having submitted a variety of
new strains they were working on developing, many unique terpene profiles were observed. Out
of 10 different samples submitted, if you were to only look at THC and CBD content, the strains
would have appeared only average and non-unique. However, comparing their terpene profiles
revealed significantly new strains had been created which possessed profiles unlike anything our
laboratory had seen before! If these samples were processed at another lab, they most likely
would have sacrificed these new strains assuming they were still common. Initial explorations
are exceptionally promising and the patients being positively impacted are certainly glad the
strains were properly analyzed!
We strongly suggest patients seek to understand their preferred strains by identifying the top few
terpenes (found on our labels)and continue to seek the same medicine in the future through
identification of a similar top terpene fingerprint, whether or not the name of the strain is the
same.
MICROBIOLOGICAL SCREENING SERVICES
Microbiological testing is done based on Colony Forming Units(CFUs)per gram of product(or
1 Og of product for foods) We look for a large breadth of contaminants and we can do so at 3
different levels,we're calling them Gold, Silver and Bronze. Gold is modeled after USP levels
for dried botanicals, Silver is at NSF/WHO level (international standards) and Bronze is
American Herbal Products Association levels. We look for 3 different types of organisms at the
level selected when the test is requested (those we test for inform us what level they would like
the test run at—Bronze, Silver, Gold).
9
The erc Shop
Moving Sustainable Medicines Forward"
10Total Aerobic Count(TAC)(Gold= 100,000 [10^5], Silver= 1,000,000 [10^6], Bronze=
10,000,000 [10^7])
lsEnterobacteria(ENT) (Gold= 1,000 [10^3], Silver= 10,000 [10^4], Bronze= 100,000
[10^5])
*Yeasts and Molds(YM) (Gold= 1,000 [10^3], Silver= 10,000 [10^4],Bronze = 100,000
[10^5])
The exponent numbers (^5)are basically the total number of zero's you have after the 1. For
example, 10^6= 1,000,000 (one million). For perspective, each colony forming unit is about 1
million organisms or more. That means, the biggest number we look at, being Bronze TAC at
10^7= 10,000,000(ten million) colonies of 1 million or more organisms (at least
10,000,000,000,000 total—ten trillion) in only one gram of material!
This type of testing represents covering up to three different standards levels for botanical
products. Each level is deemed acceptable for human use at some recognized standard. Each
medicinal cannabis patient is asked to consider their ailment and their needs to understand which
level might be most suitable for them until a more universal standard is accepted.
RESIDUAL SOLVENT ANALYSIS FOR MEDICAL CANNABIS CONCENTRATES
The Were Shop is pleased to offer residual solvent testing of concentrated medical cannabis
product forms. Concentrates can physically be produced in many different ways and some of
these production techniques may use chemical solvents. The use of chemical solvents for the
production of concentrates,to our understanding, is illegal in California. If a chemical solvent
has been used to produce the concentrate, the Collective may be at legal risk. Additionally, the
presence of chemical residues within concentrated cannabis may have a significant negative
impact on the health of the patient consuming the product. Dietary supplements, and other
botanical products,provided to the general public are required to demonstrate the absence of
residual solvents if any solvent was used in their production process. Medical cannabis
concentrate producers should seek to establish their products are free and clean of solvents as
well.
It is difficult to visually determine if a concentrate was produced using solvents and it is
impossible to detect any residues remain with the use of the human nose or visual inspection. In
order to address this matter with the appropriate sensitivity required, we have developed a
sophisticated method for the detection of a broad range of solvents that may be used.
Using a combination of head-space sampling, gas-chromatography and mass-spectrometry we
can detect trace amounts of volatile solvents that might have been used in the production of
10
The erc Shop
Moving Sustainable Medicines Forward"
concentrates.Not only can we tell you if a solvent has been used, but we will also be able to tell
you which solvent was used. Our method is non-selective and can detect trace amounts of any
solvent that might have been used, down to approximately 1ppm As we currently understand the
use of any solvents to process cannabis in CA is illegal, we aimed to be exceptionally sensitive
for these techniques.
An example of some of the solvents that can be detected:
• Acetone
• Butane
• Ethanol (alcohol)
• Hexane
• Isopropanol (isopropyl alcohol)
• Propane
• Pentane
• Toluene
PESTICIDE SCREENING
The Were Shop uses a GC-MS to detect pesticides. All pesticide use is illegal, we simply need
to be able to find the pesticide accurately and as sensitively as we can.
We believe a reasonable limit would be one based on existing EPA guidelines. So we started
with the published allowable daily intake limits for these components. We then calculated a sort
of extreme limit of the scenario of a 40Kg individual consuming (via inhalation) 1 Og of flowers
per day. Inhalation products are typically 1 OX more stringent in regulatory limits than their oral
counterparts in terms of pharmaceutical products (we're more sensitive to inhalants).
With that value calculated,we then determined what concentrations of the chemical would be
present in a 400mg flower sample that used 1 OmL of extraction solvent. That value is what we
validated we could detect at or below in our method.
We can use this method to look at flowers and we use 100mg of concentrates to look in them too.
We can't do this work in edibles, tinctures or any other products directly. 100mg of concentrates
is like assuming for every 1 g of cannabis inhaled a user would consume 0.25g of concentrate.
That's probably a little too much concentrate equivalent(maybe actually closer to 0.15g of
concentrate= 1 g of flower), but no one really knows that conversion value at this point. Being on
the larger side makes us able to find things a little better in concentrates, and since it really is
none, we felt good about doing it that way. We try to prepare ourselves for any sort of attack
from a client or other lab and we always have to be scientifically defensible on everything we do
and why we do it that way.
We have been running our pesticide method like this for a little over a year now. I would
estimate we've seen low fractions of 1%of the California Cannabis market in terms of screening
11
The Wrc Shop
Moving Sustainable Medicines Forward"
for pesticides. What we've seen within that small sample set is about 10%of the flower products
we test in that fashion have had one of those chemical residues detected (and we believe it may
be considerably higher from the little snips of segments we've been able to capture here and
there).
We most often find paclobutrazol, followed by bifenthrin, and we've also detected malathion,
cyfluthrin, fluvalinate, permethrin, bifenazate, diazinon and carbaryl. We know there are some
others on the market we can't detect with GC as well (they don't make it to the detector reliably).
To date, we have run about 1000 samples for pesticide detection and most of our clients don't
submit their concentrates for that test, it is predominantly flowers that we see for that test.
Pesticide RFD or ADI(mg/kg/day) mg/g cannabis
Acetamiprid 0.07 0.28
Allethrin-3,4(Bioallethrin) 0.005 0.02
Bifenazate 0.01 0.04
Bifenthrin 0.015 0.06
Carbaryl 0.01 0.04
Cyfluthrin 0.008 0.032
Cypermethrin 0.06 0.24
Deltamethrin (Tralomethrin deg.) 0.01 0.04
Diazinon 0.0002 0.0008
Dicofol deg. (DCBP) 0.0004 0.0016
Dimethoate 0.0022 0.0088
Disulfoton 0.00013 0.00052
Ethion 0.0005 0.002
Famphur 0.0005 0.002
Fensulfothion 0.003 0.012
Fenvalerate 0.025 0.1
Fluvalinate 0.01 0.04
Indoxacarb 0.02 0.08
Malathion 0.02 0.08
Monocrotophos 0.00005 0.0002
Myclobutanil 0.025 0.1
Naled 0.002 0.008
Paclobutrazol 0.013 0.052
Parathion-methyl 0.00025 0.001
Pendimethalin 0.1 0.4
Permethrin 0.25 1
Phorate 0,00017 0.00068
Pyridaben 0.005 0.02
Tefluthrin 0.005 0.02
Thiamethoxam deg. 1 0.026 1 0.104
12
The erc Shop
Moving Sustainable Medicines Forward"
SECTION 3. Testing Frequency and Percentage of Products Tested.
Based on your experience and expertise, outline the frequency of a testing program and the
percentage of individual products that should be tested,to ensure the medical cannabis is safe for
treatment and free of pesticides, fungicides, and microbiological organisms such as mold,
bacteria, and fungus and to verify the potency of the medical cannabis.
We firmly believe the only way to completely assure proper patient safety is to have everything
on the dispensary shelf tested. Representative sampling for each batch is critical. Places like
Washington State require every 5lbs of flowers and 15lbs of trim be tested for bulk plant
material. We have learned through our operation in WA that reproducibly sampling 5lbs of
flowers using 2.2 grams of material is completely possible.
In CA we see much more creative strategies for how to `test' yet not analyze all of the products
available. If the supply was under might tighter control, consistency was the norm instead of the
exception, and the ultimate goal was to help a patient, we'd more easily see CA dispensaries test
all of their products.
Our plan would be to sample at a minimum once a week, capturing at least 10 different products.
Ideally around 15-20%of each location should be sampled each week, as product turn-over is
rapid and new products arrive consistently at the dispensary. Multiple pick-up days could be
easily accommodated.
Ultimately each product will most likely have a uniquely associated batch size, and shelf life
potential and inventory storage time potential, along with any homogeneity concerns,to dictate
the number of samples, sample size, and sampling frequency required to be analytical accurate.
Spot-checking, once a cultivator has been qualified, may provide some additional benefit but
won't be perfect and could still result in putting patients in harm's way. While this is more cost
effective, it does come with some additional associated risks. Each of the 4 dispensaries most
likely operate slightly different from one another, and these differences can make significant
impacts on the overall testing approach and ease of working together, all of which impacts the
pricing. We aim to provide the lowest possible costs while maintaining the highest possible
quality and service offerings.
Alternatively the city could set a budget and overall goals (maybe more pesticide and mold
heavy than potency for example), and allow us to select the most optimal testing results offering
the broadest information in the most sensible and diverse fashion. We have done similar things
for a few of our clients in the past.
13
The erc Shop
Moving Sustainable Medicines Forward"
SECTION 4. Costing.
Costs start at$50 per test type. This includes sample pick-up,testing,reporting and label
generation. Bulk pricing options are available and based on the overall amount of tests
performed per month. For every 10 varieties being tested,a list price of$200 per variety would
be required. This amount of testing could be done once or more a week, as some dispensaries
have 50-100 different varieties they offer.
14
PRICING TABLE FOR
TESTING PROVIDED BY THE WERCSHOP 4TestTotal 4 Test Total 3 Test Total 3 Test Total
Priam Table Per Sample Per Sample Per Sample Per Sample Price Per Gram Price Per Gram Price Per Gram Price Per Gram
Cannabinoid Tarpons Pesticide Microbic 4 Test Total 3 Test Total 2 Test Total 1 Test Total of 1 lb.Lot of 3 lb.Lot of 1 lb.Lot of 3lb.Lot
Cost per sample $50.00 $50.00 $50.00 $50.00 $200.00 $150.00 $100.00 $50.00 $0.44 $0.147 $0.33 $0.110
Standard List Price
Cost Per Sample $47.50 $47.50 $47.50 $47.50 $190 $142.50 $95.00 $47.50 $0.42 $0.140 $0.31 $0.105
Minlmum of 10 samples picked-up
Cost Per Sample $45.00 $45.00 $45.00 $45.00 $180 $135.00 $90.00 $45.00 $0.40 $0.132 $0.30 $0.099
Minimum of 15 samples picked-up
Cost Per Sample $42.50 $42.50 $42.50 $42.50 $170 $127.50 $85.00 $42.50 $0.37 $0.125 $0.28 $0.094
Minimum of 20 samples picked-up
Cost Per Sample $40.00 $40.00 $40.00 $40.00 $160 $120.00 $80.00 $40.00 $0.35 $0.117 $0.26 $0.088
Minimum of 25 samples picked-up
The erc Shop
Moving Sustainable Medicines Forward"
SECTION 5. Sample Reports.
15
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An Independent Laboratory
Providing Safety Through InformationT'"
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flowers,can be in cannabinoid. an information for
edibles. differedes. breeding.
CBDA is a very potent anti-inflammatory Mrrcene:Effects intake of THC by
agent.This is only available when con- brain cells to increase the overall effects
sumed orally and the plant has not been of THC when ingested together.
heated before consumption. Linalool:Floral smelling,is believed to
provide some anti-cancer effects and is
known to cause severe sedation.
THCA is an excellent anti-inflammatory Limonene:Has a citrus scent and may
agent.This is only available when consumed possess anti-cancer,anti-bacterial,anti-
orally and the plant has not been fungal and anti-depression abilities.
heated before consumption. Pinenes:Pine odor,bronchodilator that
opens the lungs to more THC
absorption. It also increases focus,self-
CBD helps with pain&inflammation, is an satisfaction,and energy.
anti-convulsant,anti-arthritic and neuroprotec- Canmohvllens:Sweet,woody,dove
five agent that does not induce psychoactivity. taste responsible for anti-inflammatory
CBD modulates the effects of THC to provide and neuroprotective effects through CBy
a non-psychoactive treatment alternative. receptor activation.
THC offers relief for neuropathic pain, stimulates appetite and reduces vomiting associated
with chemotherapy. THC can be useful to reduce inflammation and also offers
neuropfotective effects. Patients should note THC can induce psychoactive,or cerebral,
effects as well. Too much THC can cause unease,anxiety and overall discomfort.
TheWercShop.com 310-703 9567
This information has not been evaluated by the FDA nor in any clinical studies with cannabis.This is based on the best information we have available today.
02013The Wem Shop,Inc.Cannabaceutical"^,Werc"',Providing SafetyThrough Information'-,the CC and thew logo are trademarks ofThe Werc Shop,Inc.
CERTIFIED CANNABACEUTICALSw 310-703-9567
® CERTIFICATE OF ANALYSIS E
The Werc Shop
www.TheWercShop.com
Analysis Performed For: Example Pur oses MAXIMUM AVAILABLE INDIVIDUAL COMPONENTS SAFETY SCREENS
A9-THC Total Total Total
Tested
On Mex.Wt. CBD Max. CBN A9-THC A9-THCA CBD CBDA Aerobic Entero- Yeast&
Strain Name Strain Typa Grow Erwlr. Lot ID Date % Wt.% Wt.% Wt.N. Wt.% WL% Wt.% Count bacteria Mold Pesticides
Flower Sample Sativa WA f312-76440 1,/&To11 19.78 1 0.26 1 ND 1.32 21.03 0.22 0.04 GOLD GOLD GOLD PASS
Concentrate Sample I India I WA 1312-76440 11/8r2011 1 32.92 1 0.78 1 0.20 1 4.36 1 32.53 1 0.64 1 0.14 1 GOLD I GOLD I GOLD PASS
INDIVIDUAL COMPONENTS
A9-THC A9-THCA CBD CBDA CBN
mg/g mg/g 11"i mgl9 mg/g
Chocolate Bar WA WA 1312-76440 11/er2011 1 6.34 1.07 0.11 ND 0.22 GOLD GOLD GOLD PASS
Tote/Wt.o/Chocolate Bar 47.2479 g Total Ma's per Chocolate Ba 299.3 1 50.6 5.1 ND 10.5
INDIVIDUAL COMPONENTS
A9-THC A9-THCA CBD CBDA CBN
mg/mL mg/mL mglmL I fri mg/mL
Ol7 WA WA 1312-76440 11/a/2011 1 32.90 49.05 0.66 0A2 1.96 GOLD GOLD GOLD PASS
Marvmum CBD WM is calculated assuming all CBDA is completely oome ted up
on healing. Mkrcbiobgiral Cobny Forming Units Tda Aerobic Total Entat Total Yeah&
MaximumTHbisSamples
amleshavteI assuming all THCA iscornaimeynonvend hdeophtvari (c1Wg)' Gant beC[e1a MOW
hapresHeta Cannabis Samt the
have been Wrown al alww wsubsecble insa and inter-plant from
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Wen,Shop.
Doty of the maenad directlyceliquid
analyzed!and eubeeeuech samples dd Des h t cu the same lot mgM not provide identical results. The NT=Not Tested 1,000,d00 <10,000 <10,000
Wem Shop.Inc.uses hghg Sustamabl moianse FonawmlWeac-,eee W Loos not currency the a a tradeted nnamethod ND=Not Demoted <10,000,000 <100,000 <11H1,000
Can�Mbaceulkals^',Moving Sustanable Medidnea Forward^',Werc",the W Logo,Erby's and the-CC are badenlahs of The W arc Shop,Inc.
Peskees Somened.
Orpznophosphams,Oganochpdnes.Avemxectins
CERTIFIED CANNABACEl1TICALSTM 310-703-9567
CERTIFICATE OF ANALYSIS E
The Werc Shop
www.TheWercShop.com
Analysis Performed For: Example Purposes MAXIMUM AVAILABLE INDIVIDUAL COMPONENTS SAFETY SCREENS
A9-THC Total Total Total
Tested On Max.Wt. CBD Max. CBN A9-THC A9-THCA CBD CBDA Aerobic Entero- Yeast 6
Strain Name Strain Type Grow Envir. Lot ID Date % Wt.% Wt.% Wt.% WL% Wt.% Wt.% Count bacteria Mold Pesticides
Flower Sample Sativa WA 1312-78940 11/920f1 19.78 1 0.26 1 ND 1.32 1 21.03 0.22 0.04 GOLD GOLD GOLD PASS
Concentrate Sample Indira I N/A 1312.76440 111W2011 1 32.92 1 0.76 1 0.20 1 4.36 1 32.53 1 0.64 1 0.14 1 GOLD I GOLD I GOLD I PASS
INDIVIDUAL COMPONENTS
A9-THC A9-THCA CBD CBDA CBN
M919 mg/g mg/9 fri mg/9
Chocolate Bar I WA NIA 1312-7e440 111W011 1 6.34 1.07 0.11 ND 0.22 GOLD GOdannoff PASS
Total Wt.of Chocolate Bar 47.2479 g Total Mors per Chocolate 9a 299.3 50.6 5.1 ND 1 10.5
Oil NIA IN/A 1312.76M 111112011 1 1263.211 0.00 1 5.28 1 0.00 115.841 1 GOLD I GOLD I GOLD IPASS
Maximum CBD Wt%is calculated assumirg all CBDA Is completely connected upon heating. Micebidogiral Cdony Forming Units Total Aerobic Tolal Enten, Total Yeas18
Maximum THC Wl%is calculated assuming aN THCA is com m pN:taly cvanaa upon heating. (d.1g): Court bactesie Mold
Herbal Cannabis Samples have been knvxn to show considerable intra-arts inter-plats variability. The teal results,presented above are primarily 1W." <I." <1,000
mpresentative only of the matenai directly analysed and subsequent samples collected from the same lot might M povde identical results. The NT=Not Tested <1.000.000 <to," <10."
Werc Shop,Inc.uses high peda rw tec mance laud chnatographic hnques and does not currently have a fully"Ideled method. ND=Not Detected 10,000,000 <100,000 OWN!)
CannabereulMais'v,MovIW Sustainable Medicines ForwaM's,Wart's,the W Logo,Emy" aM the-CC are hademaft M The Wem Shop,Inc.
Pesticides Sdeaned:
Organophosphates,Or,anochbrmes,Avennectins
O® CERTIFIED CANNABACEUTICALSTM M The Werc Shop 310-703-9567
CERTIFICATE OF ANALYSIS www.TheWercShop.com
Analysis Performed For: Example Purposes MAXIMUM AVAILABLE I INDIVIDUAL COMPONENTS SAFETY SCREENS
A8-THC CBD Total Total Total
Grow Customer's Tasted On Max.M. Max.Wt. CBN A9-THC e9-THCA CBD CBDA Aerobic Entero- Yeast 8
Strain Name Strain Type Envir. Lot■ Lot ID Date X % Wt.% wt.X Wt.% Wt.% Wt.% Count bacteria Mold Pesticides
Triple OG Setiva Dom. Indoor 66782 118945780 Y/1820f f 18.76 1 0.30 ND 0.69 20.59 023 0-08 GOLD GOLD GOLD PASS
White Diamond Sativa Dom. Indoor 1 57889 118945780 5012011 1 15.85 1 0.29 1 ND 0.92 17.00 0.24 1 0.07 1 GOLD GOLD I GOLD PASS
Black Diamond OG IlMica Dan. Indoor 1 26935 118945780 591a2017 1 18.16 1 0.28 1 ND 1 0.65 16.53 1 024 1 0-06 1 GOLD I GOLD I GOLD I PASS
Pori OG SeOlnd Indoor 1 29875 III&Q-457801 59182011 1 6.18 110.36 1 ND 1 0.61 5.21 1 0.61 1 11.17 1 GOLD I GOLD I GOLD I PASS
Maserum CBD WM is calculated assuming all CBDA Is coa Aially convert"upon heetiN Mi crabblogpl CObny Fpr0lrlg Wg): Totalound Total Enris TOILead &
Mesirum THC M% calculated ee asses all THCA is umrerable wavered i upon heanig. (sfW9f: Court bBpt 00 MOM
Haibal Canrwbis Sanpbs have been Imam m zlww considerable ntra-ant inter-ppM varie0111ty.The test results presented above ere hop,liy representative f 00,000 <1,000 -1.XQ
Onlygtlie material Lireglyaimphic amisubsequant sampMs crranUy have the samablmghingprovide identical results. TheWerc Shop,lnc.uses M1gM1 NT-Nee Tested c1,Og0,000 <I . <10.
pedormarce liquid ,Ma,4OSueta IacM1npueaant does rotcuaenl,Thave a lolly valkged anal th. ND=Nq Detected <10.000,000 <100,000 <100,000
CannabeceulimkTM,Moving Sustainable Metlomres FomaMT",WarcTM,Me W Logo,ErbyTM eM Ine'CC are vaeemans M Tam Were Shop.Inc.
0rganaPM1ozPM1ates,0rganocM1loM1res,Avemecans
The erc Shop
Moving Sustainable Medicines Forward
Exhibit A
Resumes
Dr. Jeffrey C. Raber
Dr. Jeffrey C. Raber is a serial entrepreneur with a thirst for knowledge and an ability to envision
new technologies and the brighter future they can help build. Dr. Raber was also an early mover
in the internet service provider market when he helped found a local provider in 1995 while
working towards his B.S. in Biochemistry from Lebanon Valley College. Dr. Raber studied plant
phylogenetics of the RuBisCO enzyme while at LVC and was named to the USA Today 1997
All-USA College Academic Team for his research accomplishments in this area. Dr. Raber
graduated from LVC and decided to move from his hometown in Pennsylvania and expand his
opportunities by attending graduate school in Los Angeles, CA at USC.
Dr. Raber completed his degree at USC in less than 5 years and was awarded the Harold and
Lillian Moulton Fellowship. Upon receipt of his degree from USC Dr. Raber was asked to join a
start-up company as the Director of Product Development where he created new molecular
scaffolds for use as starting points in the investigation of new pharmaceuticals by medicinal
chemists and successfully transferred proprietary reaction methodology and know-how to a
production partner.
2010—Present: Founder, CEO & CVO of The Were Shop, LLC
Responsible for corporate vision, product development and commercialization of The
Were Shop's offerings to the medical cannabis and greater sustainable chemistry markets.
2004—Present: Member of Board of Directors and President at KinetiChem,Inc.
Provide oversight of the research, development and commercialization of KinetiChem's
continuous flow microreactor technology platform.
2002—2005: Director of Product Development at Avrion Molecular, Inc.
Responsible for the research, development and commercialization of Avrion's proprietary
reaction methodology. Responsible for technology transfer efforts to third party
manufacturer for the production of Avrion's first commercially available products.
2003—2005: Research Assistant at the University of Southern California.
Responsible for lab oversight as well as the development of new synthetic methodologies
and the creation of novel biologically active compounds.
1997—2002: Independent Contractor.
Provided organic chemistry tutoring and IT consulting services.
1995—1997: System Administrator at Lebanon MobileFone.
Responsible for starting up and maintaining internet service provider business through
installation and maintenance of required servers and networking hardware and software.
1994— 1997: Sole Proprietor of Creative Technology Solutions.
Provided IT consulting, computer training, and custom web page design services.
16
The erc Shop
Moving Sustainable Medicines Forward"
Education
2002—2003: Post-Doctoral Fellowship; University of Southern California
Research: New synthetic methodologies.
Advisor: Prof.Nicos A. Petasis.
1997-2002: Ph.D. Organic Chemistry; University of Southern California
Dissertation: Design and synthesis of novel heterocycles and peptidomimetics from
organoboronic acids, amines and carbonyl compounds.
Advisor: Prof.Nicos A. Petasis.
Award: Harold & Lillian Moulton Fellowship
1993— 1997: B.S. Biochemistry; Lebanon Valley College
GPA: cum. 3.41/4.00; in major 3.54/4.00.
Research Activities:
Biochemist rv: Molecular modeling and phylogenetic analysis of Ribulose-1,5-
Bisphosphate Carboxylase/Oxygenase in photosynthetic organisms.
Computational Chemistry: Molecular modeling in education directed at producing quick
time movies for distribution via the Internet.
Organic Chemistry: Synthetic studies on the addition of organometallic reagents to
quinones.
Awards:
Vickroy Scholarship,Andrew&Ruth Bender Scholarship, Who's Who in College Students,
USA Today All-USA Academic Team,AIC Outstanding Achievement in Biochemistry.
Patents & Publications
Nitrogen-Containing Heterocycles, Petasis,N. A., Yao,X., Raber, J. C., US Patent, 6,927,294
(2005).
Method and Apparatus for Mixing and Dispensing Products, Raber, J. C.,US Patent 8,210,736
(2012).
Reactions of Alkyllithium and Grignard Reagents with Benzoquinone: Evidence for an Electron-
Transfer Mechanism,McKinley, J., Aponick, A., Raber, J. C., Fritz, C., Montgomery, D., and
Wigal, C.T., J. Org. Chem., 1997, 62,4874.
Quinone Alkylation Using Organocadmium Reagents: A General Synthesis of Quinols,
McKinley, J.Aponick, A., Raber, J. C., and Wigal, C. T.,J. Org. Chem., 1998, 63, 2676.
Using Cyclic Voltammetry and Molecular Modeling to Determine Substituent Effects in the
One-Electron Reduction of Benzoquinones, Heffner,J. E., Raber, J. C., Moe, O. A., and Wigal,
C. T., J.Chem. Ed., 1998, 75, 365.
17
The erc Shop
Moving Sustainable Medicines Forward"
Halogen/Lithium Exchange in Hydrocarbon Media; Basic and Continuous Reactor Studies,
Slocum,D.W., Kusmic, D.,Raber,J. C., Whitley, P. E, Tetrahedron Letters, 2010, 51 (2010)
4793-4796.
Determination of Pesticides in Cannabis Smoke, Sullivan, N., Elzinga, S., Raber, J. C., Journal
of Toxicology, 2013, Article ID 378168.
Presentations
"A Web Site for the Chemistry Department at Lebanon Valley College: Information on Students,
Chemistry Programs and Molecular Modeling,"Cornelius, R. D., Wigal, C. T., Raber, J. C.,
presented at the American Chemical Society, Middle Atlantic Regional Meeting, March 1996.
"A Model of the Evolution of Type I Ribulose-1,5-Bisphosphate Carboxylase/Oxygenase
(RuBisCO) from the Common Ancestor of the Spinach Chloroplast and Synechococcus,"Raber,
J. C., Westerhoff, L. M., Moe, O.A., presented at the Pennsylvania Academy of Science, April
12-14, 1996.
"A Phylogeny of Photosynthetic Bacteria and Chloroplasts Based on Parsimony Analysis of rbcL
Sequences," Westerhoff, L. M., Raber, J. C., Williams, S. E., presented at The Pennsylvania
Academy of Science, April 12-14, 1996.
"A Model Web Site for a Chemistry Department at a Small College: Instructional Support,
Departmental Information, and Delivery of Materials for Molecular Modeling," Cornelius, R. D.,
Wigal, C. T., Raber, J. C.,presented at the 213th National Meeting of the American Chemical
Society, San Francisco, CA, April 13-17, 1997.
"New Methodology For Quinol Synthesis,"Aponick,A., Raber, J. C.,and Wigal, C. T.,
presented at the 214th National American Chemical Society Meeting in Las Vegas, September
1997.
"Integration of Molecular Modeling Into the Chemistry Laboratory Curriculum," Wigal, C.T.,
Raber,J. C., and Cornelius, R. D.,presented at the 214th National American Chemical Society
Meeting in Las Vegas, September 1997.
"Synthesis of Benzodiazepines from 1,3-Diamines and Organoboronic Acids", Petasis,N. A.,
Raber, J. C., Patel, Z. D.,presented at the 220th American Chemical Society meeting in
Washington, D.C., August 20-24, 2000.
"Synthesis of Benzodiazepine Derivatives Using Organoboronic Acids", Petasis,N.A., Raber,J.
C., Yao, X.,presented at the 222nd American Chemical Society meeting in Chicago, IL, August
26-30, 2001.
18
The erc Shop
Moving Sustainable Medicines Forward"
"New Boron-Based Multi-Component Reactions", Petasis,N.A., Douglass, B. J., Raber, J. C.,
presented at the 229th American Chemical Society meeting in San Diego, CA, March 13-17,
2005.
"Makeover of the Lithium/Halogen Exchange: Continuous Reactor Studies", Slocum, D. W.,
Kusmic,D., Raber, J. C., Reinsheld, T. K., Whitley, P. E., presented at the 240th American
Chemical Society meeting in Boston, MA August 22-26, 2010.
"Flow Chemistry vs. Batch Chemistry: Halogen/metal Exchange Studies", Slocum, D. W.,
Kusmic, D., DiLoreto, M. A., Raber,J. C., Whitley, P. E., presented at the 42nd National
Organic Symposium,Princeton,NJ, June 5-9, 2011.
"Scalable,Non-cryogenic Approach to Halogen/metal Exchange and Subsequent
Derivatization",Whitley, P. E., Kusmic, D., Reinscheld, T. K., DiLoreto, M. A., Raber, J. C.,
Slocum, D. W., presented at the 43rd IUPAC World Chemistry Congress, San Juan, Puerto Rico,
July 30-Aug. 7, 2011.
"Inspection of the Micro and Molecular Components of Cannabis", Raber, J.C.,presented at the
CBD Conference in Laguna Woods, CA January, 22 2011.
"Keeping A Weed Free Garden: Scientific Perspective on the Public Health and Safety of
Medical Cannabis", Raber, J.C.,presented at the New Jersey Association of Forensic Scientists,
Atlantic City,NJ, May 10,2014.
"Continuous TEMPO-Bleach Oxidation Using A Film-Shear Reactor: Rapid Oxidation of
Alcohols In A Biphasic System", Tinder, R., Whitley, P. E., Slocum, D. W., Reinscheld, T. K.,
Austin,N. D., Bush, S. J., Raber, J. C.,presented at the 244th American Chemical Society
meeting in Philadelphia, PA, August 19-23, 2012.
"Cannabinoid and Terpenoid Profiling of Medical Cannabis in California", Raber, J.C., Elzinga,
S.E., Raber, M.E., Fischedick, J., Gieringer, D., presented at the International Association of
Cannabinoid Medicine 2013 Bi-Annual Meeting, Cologne, Germany, September 27-28, 2013.
"Cannabinoid and Terpenoid Profiling in California and Washington", Raber,J.C., Elzinga, S.E.,
Raber, M.E., Douglass, B.J., Miller, C., Kendziorek, A., Fischedick,J., Gieringer, D., presented
at the International Cannabinoid Research Society 2014 Annual Meeting, Baveno, Italy, June 28
to July 1,2014.
Professional Memberships
American Chemical Society Member, 1993 -Present
Pennsylvania Society of Scientists, 1995 & 1996
Lebanon Valley Chamber of Commerce, 1996 & 1997
19
The Werc Shop
Moving Sustainable Medicines Forward"
Sytze Elzinga
Sytze received his bachelor's degree in biochemistry and subsequently went on to complete his
Masters of Science in Natural Product Chemistry from Leiden University in The Netherlands in
2006. Mr. Elzinga early research work involved investigations of Artemisinin and sesquiterpene
precursors found in dead and green leaves of Artemisia annua L. Additional work involved
investigation of the origin of licorice through the use of NMR. Following the completion of his
master's thesis Mr. Elzinga moved on to Farmalyse, a pharmaceutical contract laboratory which
performs the quality control and release of pharmaceutical products. Farmalyse possesses the
sole contract with the Dutch government for the quality control of the medicinal cannabis
provided on prescription through the pharmacies in the national medical marijuana program. At
Farmalyse Mr. Elzinga was responsible for the quality control of all medicinal cannabis for the
Dutch pharmaceutical market.
Mr. Elzinga experience is invaluable and simply can't be duplicated. No other laboratory in the
United States can boast such experience and expertise pertaining to the proper analysis and
quality control of medicinal cannabis. Currently at The Werc Shop, Mr. Elzinga continues to
push the frontier of scientific understanding of medicinal cannabis.
April 2011 —Currently Director of Quality Control and Assurance, The Were Shop, Los
Angeles,CA,USA
The Werc Shop is an analytical laboratory primarily focused on the quality control of medicinal
marijuana. My responsibilities, in addition to routine oversight of results and reports, include
writing and developing protocols, method validation and the isolation of cannabinoids for use as
analytical reference standards.
July 2010—April 2011 Manager of Edible Production, Herbal Solutions, Long Beach, CA,
USA
At Herbal Solutions I coordinated the production of edibles containing medicinal marijuana.
Edibles had been notoriously inconsistent and this caused complaints from patients who wanted
reliable medicine. Under my supervision,various new product lines were developed. All of the
products are now made from quality controlled starting materials which results in consistent
edibles with an exactly known strength. Various methods were developed and optimized to be
able to provide potent edibles without the need of dangerous chemicals.
August 2006— June 2010 Laboratory Manager, Echo Pharmaceuticals / Farmalyse
Weesp/Zaandam, The Netherlands
From August 2006 to August 2007 I worked part-time at Farmalyse -a pharmaceutical contract
laboratory which performs the quality control and release of pharmaceutical products in addition
to possessing the sole contract with the Dutch government for the quality control of the national
medicinal marijuana which is available on prescription in Dutch pharmacies. At Farmalyse I was
responsible for the quality control and release of all medicinal marijuana for the Dutch
pharmaceutical market. During this period I was further responsible for research carried out on
the purification of THC from marijuana. This research led to a spin-off company - Echo
Pharmaceuticals,where I was a full-time employee since November 2007 and oversaw all
laboratory activities. Within Echo I was responsible for the purification of THC which was to be
20
The erc Shop
Moving Sustainable Medicines Forward
used as an active pharmaceutical ingredient(API) for the production of tablets. Various research
projects have been coordinated by me ranging from formulation development to isolation.
November 2006—August 2007,Laboratory Technician,Leiden University,Department of
Natural Products, The Netherlands
After completing my Master's degree, the Department of Natural Products solicited me to remain
at Leiden University to provide students with help on their various research products.
Maintenance of laboratory equipment and teaching classes on gas chromatography were also
elements in my work. This position was part-time and was combined with working at Farmalyse
/Echo Pharmaceuticals.
2005—2006 Master's Thesis
Title: Chemical Differentiation of Licorice by Nuclear Magnetic Spectroscopy
Licorice samples from different geographical locations were measured with NMR, after which
the collected data was analyzed by principal component analysis. This resulted in identification
of various proton signals that were related to the chemical compounds causing differentiation
between geographical locations. Various chromatographic techniques were employed to do
targeted isolation of the differentiating compounds. With the means of two dimensional NMR,
full structure elucidation was completed and 4 new flavonoid-glycosides were identified.
September 2003—January 2004 Bachelor Research Project 2
Title: Extraction and Quantification of the Antimalarial Medicine Artemisinine from
Artemisia annua
At the Hanzehogeschool I developed and validated a thin layer chromatography method to
quantify artemisine with the use of a PC scanner. It was important that the developed method
could he applied in Africa and would not be dependent on laboratory infrastructure. During this
period I also developed an efficient extraction method. The result of this research has been
presented to the Ministry of Health in The Gambia. In December 2007 the first fields with
Artemisia annua have been planted in The Gambia and they plan to start a clinical test with
standardized plant extracts in the near future.
February—July 2003 Bachelor Research Project 1
Title: Artemisinin and Sesquiterpene Precursors in Dead and Green Leaves of Artemisia
annua L. Crops
This research was done at the department of Herb and Weed Ecology at the University of
Wageningen.GCMS analysis of various plant parts were completed at Plant Research International
and the data collected resulted in a publication in 2007. Lommen WJ, Elzinga S, Verstappen FW,
Bouwmeester HJ.Artemisinin and sesquiterpene precursors in dead and green leaves of Artemisia
annua L. crops. Planta Med. 2007 Aug; 73(10):1133-9
Patents and Additional Publications:
Novel Enhanced Terpene Compositions, Systems, Processes and Products Thereby, Elzinga, S.
and Raber, J.C., US provisional patent filed 2013.
21
The Wric Shop
Moving Sustainable Medicines Forward"
Novel Enhanced Solvent-Free Processing, System and Methods, Elzinga, S. and Raber, J.C., US
provisional patent filed 2013.
Determination of Pesticides in Cannabis Smoke, Sullivan,N., Elzinga, S., Raber, J. C., Journal
of Toxicology,2013,Article ID 378168.
Skills:
Laboratory techniques: HPLC, UHPLC,NMR, GC, MS, Preparative Chromatography, PCR
and various other chemical and biochemical techniques
Computer: Knowledge in MS office, Waters Empower, Dionex Chromeleon,
Simca
Certificates: License for working with GMOs
Languages: Dutch: native
English: oral and written fluency
German: oral basic, written basic
22
The erc Shop
Moving Sustainable Medicines Forward'
Raquel Keledjian
Experienced Scientist
Problem Solver/Data Analyst/Data Organizing/Documentation Developer
Knowledgeable, Organized, Resourceful, Expedient
Strong background in Medicinal Chemistry, highly knowledgeable in analytical method
development, experienced in leading cross-functional teams.
Experienced scientist with numerous years in training in both organic, analytical chemistry, and
analytical method development. Professional focus on solving problems, motivating people to
get the job done. Strong background in pharmaceutically relevant compounds. Acknowledged
as valued employee that finishes projects in organized and timely manner.
Skills and Accomplishments
• Experienced in over 14 years of scientific research stemming from bio-medicinal,
pharmaceutical , polymer, and formulation sciences.
• Experienced in the managing, teaching, and training of research scientists
• Experienced in organizing and overseeing production of prototype batches.
• Strong background in organic chemistry, multi-step synthesis, and formulation.
• Experienced in carrying reactions from analytical scale to process scale.
• Proficient in instrumental methods of analyses.HPLC,LC/MS,GUMS,GC,NMR,FT-IR,ICP and UVA.
• Experienced in separation technologies such as SPE,Prep.Chromatography,and column chromatography with an
emphasis of separation of drug metabolites.
• Experience in working in a cGMP environment.
• Experienced with FDA guidelines
• Familiar with Class-VP,ChemStation,and Empower software for processing of analytical data.
• Excellent at multi-tasking and finishing projects before deadlines.
• Strong leadership and management skills.
• Experienced in synthesis of natural compounds for the purpose of biological testing.
• Experienced in compound purification and analytical techniques. Flash chromatography,
preparative TLC, and preparative HPLC.
• Scientific word processing(ChemDraw,MS Word,MS Power Point,Excel,Mathcad,Nuts
NMR).
• Experienced user of Chemical databases (e.g. Beilstein, Scifinder).
• Experienced with the supervision,training, and teaching of research assistants.
23
The erc Shop
Moving Sustainable Medicines Forward"
Positions and Employment
7/2009-current Senior Scientist,PPG Aerospace
• Responsible for overseeing the development, and implementation of new Aerospace
Sealant.
o Researching and invention of new ideas to facilitate the development of the
product.
o Overseeing and managing of research chemists in order to drive the development
of the project in the right direction.
• Responsible for synthesis of new and current polymers, in order to support formulation of
sealants for the aerospace industry.
• Responsible for formulation of newly synthesized polymers for testing and validating
properties of newly synthesized polymers.
• Responsible for maintain analytical equipment, GPC, GC, Karl Fisher Titrater, and
numerous other titrating instruments.
• Responsible for developing and implementing efficient methods for analyzing end
product polymers.
• Part of AS9100 auditing team for quality assurance(QA) adherence.
4/2004-10/2008 Staff Scientist, Codexis, Inc., a subsidiary of Maxygen,Inc..
• Managing high throughput screening, identifying, and scaling processes for synthesis of
important biologically active compounds via chemo-enzymatic routes.
• Excellent at developing fast analytical methods, for the identification, purification, and
chiral resolution of these compounds.
• Worked closely with partnered Pharma companies for identification, separation, and large
scale isolation of drug metabolites
• Accountable for QC (quality control) and QA (quality assurance) of compounds that are
for sale.
• Responsible for proper maintenance of laboratory notebooks in order to adhere to Good
Research Practice Policy and FDA regulatory requirements.
• In charge of proper waste management and documentation of waste manifests for
maintenance of safe working environment as warranted by OSHA.
• Managing of bachelors chemist: teaching them basic concepts of HPLC and GC, and
providing them with procedures and tasks that need to completed in a timely manner.
8/1998-12/2003 Graduate Research Assistant, University of Southern California,
Department of Chemistry
• Design and synthesis of novel lipid mediators which are key regulators of the
inflammatory cascade.
• Developed new synthetic methodologies and accomplished the total synthesis of
presqualene diphosphate (PSPP), lipoxins, as well as their structural analogues.
• Incorporated key organometallic coupling reactions like the Witting, Suzuki,
Songoashira, and the Negishi, in order to complete the carbon skeleton of both PSPP and
lipoxins.
24
The erc Shop
Moving Sustainable Medicines Forward"
Education
2003 Ph.D, Organic Chemistry University of Southern California
• Department of Chemistry and Loker Hydrocarbon Research Institute
Advisor: Professor Nicos A. Petasis
• Thesis: Design and Synthesis of Novel Lipid Mediators
1998 B.S., Chemistry University of California, Irvine
Honors, Awards, Certifications, and Training Seminars
• 3/2012 Accelerated coarse on Design of Experiment, Focused on Formulation.
• 11/2011 Certification in accelerated management course for the purpose of managing
scientists.
• 5/2010 Attended seminar on latest technological development of HEL1C HPLC separation,
offered by Waters.
• 10/2008 Attended seminar on of troubleshooting and fixing of hardware issues with
Shimadzu HPLC systems, offered by Shimadzu.
• 1/2005 Attended seminar on separation technologies, and basics of HPLC method
development, offered by Phenomenex.
• 05/02-08/02 Harold Moulton Graduate Fellowship,
Loker Hydrocarbon Research Institute, University of Southern California.
• 06/97-08/97 NIST research fellowship.
• 03/97-06/97 Undergraduate Research Fellowship, University of California, Irvine.
25
Hindawi fToxPublishing Corporation
JournalJaual of Toxicology
Volume 2013,Article ID 378168,6 pages
http:lldx.doi.org/10.1155/2013/378168 (W
Hindawi
Research Article
Determination of Pesticide Residues in Cannabis Smoke
Nicholas Sullivan,Sytze Elzinga,and Jeffrey C. Raber
The Werc Shop,Inc.,Pasadena,CA 91107, USA
Correspondence should be addressed to Jeffrey C.Raber,jeff@thewereshop.com
Received 11 February 2013•Accepted 22 April 2013
Academic Editor:Steven J.Bursian
Copyright®2013 Nicholas Sullivan et al. This is an open access article distributed under the Creative Commons Attribution
License,which permits unrestricted use,distribution,and reproduction in any medium,provided the original work is properly
cited.
The present study was conducted in order to quantify to what extent cannabis consumers may be exposed to pesticide and
other chemical residues through inhaled mainstream cannabis smoke.Three different smoking devices were evaluated in order to
provide a generalized data set representative of pesticide exposures possible for medical cannabis users.Three different pesticides,
bifenthrin,diazinon,and permethrin,along with the plant growth regulator paclobutrazol,which are readily available to cultivators
in commercial products,were investigated in the experiment.Smoke generated from the smoking devices was condensed in tandem
chilled gas traps and analyzed with gas chromatography-mass spectrometry(GC-MS).Recoveries of residues were as high as 69.5%
depending on the device used and the component investigated,suggesting that the potential of pesticide and chemical residue
exposures to cannabis users is substantial and may pose a significant toxicological threat in the absence of adequate regulatory
frameworks.
1. Introduction patients. Mainstream smoke consists of the smoke inhaled
from a smoking device directly while sidestream smoke refers
Cannabis sativa L. has been widely utilized by humans for to smoke that otherwise escapes the device and is not directly
thousands of years for the relief of a wide range of physi- inhaled.
ological ailments. In the United States, there are currently
18 different states and the District of Columbia that legally The ubiquitous use of pesticides in agriculture has earned
allow for the medical use of cannabis, and most recently itself a long history in the United States from the outset of
the states of Colorado and Washington have legalized the the Insecticide Act passed in 1910 to the now heavily engaged
use of cannabis by adults for recreational purposes. State US Environmental Protection Agency (US EPA), Fede-
lawmakers and regulatory departments are now being tasked ral Department of Agriculture (FDA), and United States
to best enact appropriate laws, rules,and regulations on the Department of Agriculture (USDA) along with individual
use of cannabis for both medicinal and recreational purposes. state regulators [1]. According to a report issued by the US
While medicinal use of cannabis in a smoked form may General Accounting Office(GAO)in 2003,the use of pesti-
be widely debated as an effective delivery form, rapidity of cides on tobacco crops was limited to 37 pesticides, which
effect and ease of titration of dose lend it to be extensively included various organochlorides, organophosphates, and
used by many patients as their preferred delivery method other classes of pesticides.Allowable pesticides and residue
today. Undoubtedly, recreational use will see considerable levels on food crops are determined by the US EPA,while the
consumption via smoking of dried cannabis flowers. In an testing and monitoring of the presence and levels of residues
effort to help aid patients, lawmakers, regulators, and the are conducted by the FDA and USDA. However, since
general public understand the potential harms of contam- tobacco is not a food crop,the US EPA has not set tolerances
inated cannabis we sought to determine to what extent on the residue levels on tobacco crops.Consequently,tobacco
pesticide residues may transfer into the mainstream smoke, is only monitored for compliance with US EPA approved
produced from cannabis, when inhaled through various pesticides while the residue levels are not federally regulated
smoking devices currently being used by medical cannabis [2].
2 Journal of Toxicology
To date, there are no approved pesticides or application smoke,a larger portion of pyrolysis products are found[7].In
limits established for use on cannabis crops by the US EPA; the same study,it was determined that about one half of 14C-
therefore,all pesticide use on this crop is currently illegal[3]. labeled pesticides were retained in a cotton cigarette filter in
The use of pesticides and plant growth regulators in medicinal a nonselective manner[7].For the most part,since cigarette
cannabis cultivation has been found to be quite prevalent filters absorb a significant portion of the volatilized residues
by both testing laboratories and authority laboratories alike. and a substantial toxicological threat is already associated
Many commercially available pesticide containing products with smoking tobacco,little concern for pesticide exposure
or nutrient systems,some only approved for use on ornamen- to tobacco smokers has been considered [2, 71. Cannabis
tal crops,are widely available from a variety of sources includ- smoking devices often do not include filtration processes
ing hardware stores,specialty indoor hydroponic shops,and and because of this the potential quantities of pesticide
various, sometimes unscrupulous, online vendors. While residues that may be consumed increases dramatically when
18 states allow cannabis for medicinal use, the majority of compared with tobacco smoking. In the present study, we
the current medical cannabis supply lacks regulations and chose to evaluate both filtered and nonfiltered smoking
enforcement related to the quality and safety of the plant devices to better understand this effect with cannabis and
material for consumption. Laboratories operating within commonly employed medical cannabis consumption meth-
California have reported that cannabis samples contaminated ods. While it is known that combustion of plant mate-
with residual pesticides are frequently encountered.In 2009 rial causes the formation of carcinogens, there has been
the Los Angeles City Attorney's office covertly acquired no direct correlation in the formation of lung cancers to
and then tested three medical cannabis samples available to the inhalation of combusted cannabis [8]. The presence of
patients through dispensaries and found that in two of the pesticide residues is therefore critical to be monitored, and
samples exceedingly high levels of bifenthrin were found. furthermore, those individuals seeking to use cannabis for
In one sample, 1600 times the legal digestible amount was medicinal purposes may also be more physiologically sus-
measured, and in the other, 85 times the legal limit was ceptible to negative impacts caused by the presence of these
measured,although the exact quantities were not stated [4]. residues.
Many medical cannabis products are currently cultivated, To prevent overtreatment of tobacco with pesticides,
processed, and prepared by private entities that are not certain application limits on crop treatment have been
regulated by external agencies. The lack of quality control imposed to minimize exposure to tobacco smokers,but these
results in patients potentially being exposed to cannabis are not fully federally regulated [2, 9, 101. Industrial and
contaminated with toxic levels of pesticides. Although not other laboratories have attempted to quantify the levels at
yet directly quantified, additional health complications in which pesticide residues transfer into the smoke stream in
patients may become a contingency of pesticide exposure order to validate what quantities of pesticides may safely
and may also interfere with long-term cannabis use studies. be applied to crops, and these values have been used to
Regardless, pesticide toxicity is well documented [5) and help moderate the levels of pesticide exposure of the public
more importantly can pose substantial threats to immuno- [5, 11]. Considering that there currently exists a significant
compromised patients or patients with other conditions,such lack of analogous regulations set in place for the medical
as diseases of the liver, that may intensify the toxicological cannabis supply,it is important that the potential for pesticide
effects of pesticide exposure[6].Additionally,during heating exposure is evaluated under conditions commonly employed
pyrolysis products from the plant material form a highly com- by the medicinal user. In order to determine the existence
plex mixture of products,many of which may interact with of pesticide and chemical residues in the cannabis smoke
the pesticides or pyrolysis products of the pesticides forming stream,a number of pesticides and a plant growth regulator
more toxic materials,or highly toxic pyrolysis products may which are readily available to cannabis cultivators and have
form from the pesticide residues alone [7].As stated in the been measured in high frequency in various medical cannabis
review by US General Accounting Office (GAO) in 2003, products (unpublished data, The Werc Shop, Inc., 4) were
exposure to organophosphate pesticides through inhalation selected for the study. Three different smoking devices,
causes the most rapid appearance of toxic symptoms,and the chosen to provide a broad overview,were used in the study;
primary cause of death from organophosphate pesticides is a small glass pipe, a water pipe, and an identical water pipe
respiratory failure [2], Considering these issues, evaluation outfitted with activated carbon filters and cotton filters.
of the exposure from contaminated cannabis needs to be
urgently addressed so that new regulations can be properly
guided. 2. Methods
A previous pesticide study conducted with filtered
tobacco cigarettes had positively identified the recovery of 2.1. Chemicals. Acetonitrile, methanol, and water of aria-
pesticides in the mainstream smoke to range from 2 to 16% lytical grade as well as washing acetone and methanol of
[8]. Additionally, the distributions of volatilized pesticides laboratory grade were purchased from Sigma Aldrich, St.
and pyrolysis products in tobacco cigarette mainstream Louis, MO, USA. Bifenthrin and diazinon were purchased
smoke and sidestream smoke were found to differ [7]. The from Chem Service, West Chester, PA, USA. Paclobutrazol
mainstream smoke pesticide residues consist primarily of and permethrin were purchased from Sigma Aldrich, St.
unpyrolized pesticides carried over by distillation charac- Louis, MO, USA. Virgin coconut carbon and cotton were
teristics related to steam volatility, while in the sidestream obtained from Scientific Inhalations,Grass Valley,CA,USA.
Journal of Toxicology 3
2.2. Smoking Devices. The water pipe was manufactured by each mL was added, the flask was then placed on a rotary
Scientific Inhalations, Inc. and is named the McFinn Triple evaporator and rotated at 50 rpm for 3 minutes while under
Filtered Water Pipe having a vapor flow path consisting of first vacuum. This was repeated until all 8.30ml, were added
a 2.5 cm cup for placement of the flower material,followed by and then evaporated. The flask was then covered in a dark
a 2.5 cm connector,flowing in to a 10 cm filter,down further encasing and stored at —20°C until further used. From the
into a 15 cm water chamber having a 3.1 cm inner diameter spiked plant material, duplicate samples were prepared and
and a water fill line 3.8 cm from the base.The water chamber evaluated for homogeneity of the pesticide distribution.The
also has a second 12.5 cm filter chamber connected at a 45' measured values were averaged and this value was used for
angle through a 5 cm fitting that is located 12.5 cm above the recovery calculations in the smoke condensate.
the base of the water chamber, and the second arm then
further connects to a mouth-piece. A special mouth-piece 2.5.Apparatus and Method far Condensation and Recovery of
was custom made by Scientific Inhalations to allow for easy Pesticide Residues in Smoke Stream. The smoke stream was
connection to the gas-wash bottle apparatus. The glass pipe collected by being directed through two gas washing bottles
was custom made by Scientific Inhalations to be 10.5 cm long which were placed in tandem cold methanol traps both held
with a 3.1 cm chamber diameter and 1.1 cm inner diameter at —48°C. The gas wash bottles were filled with 100 mL of
that included a special mouth-piece configuration for easy analytical grade methanol each. The gas wash bottles were
adaption to the gas-wash bottle apparatus. then connected with a 6 inch tube in tandem to a vacuum
pump intermediated by a gas flow regulator.The end of the
2.3. Method for Identification and Quantification of Pesticide system was then fixed to the smoking devices via a frosted
Residues by GC-MS. Analysis was conducted with a GCMS- glass fitting or direct connection via tygon tubing.A vacuum
QP2010 PLUS (Shimadzu, Japan) gas chromatograph-mass was applied to the system using a diaphragm vacuum pump
spectrometer.Separations were performed using a Shimadzu (MD 4C,Vacuubrand,Essex,CT,USA)in order to pull smoke
SHRXI-5MS 30 meter,0.25 mm i.d.,and 0.25 um film thick- from the smoking device and through both of the gas wash
ness column. Gas chromatography parameters were as fol- bottles.
lows:injector temperature 250.0°C,splitless injection mode, In order to ensure that the draw rate and vacuum pressure
column oven temp.50.0°C held for one minute,followed by were constant throughout all experiments, a simple device
an increase to 125°C by 25C/min, and finally increased to was arranged to monitor the vacuum settings. A long glass
300°C for 15 minutes by 10'C/min.The column flow was set column was placed upright in a water vessel filled with a
to 1.69 mL/min 99.999% Helium. MS scan was carried out constant volume of water.To the top end of the glass column,
in selected ion monitoring(SIM) mode with two reference a tubing fitting was fixed and vacuum tubing connected.
ions for each pesticide to avoid false positives from the To the tubing, a valve at a constant setting was opened
complex matrixes.Pesticide calibration curves were prepared slightly to allow air to enter and prevent the water from
in matched matrixes, which were prepared from unspiked being pulled into the vacuum. After having twelve different
plant material using the same smoking procedure used for all current medical cannabis patients inhale through the end of
the experiments as described in Section 2.6. a tube attached to the valve while instructed to emulate the
draw strength they typically use for these smoking devices,
2.4. Preparation of Pesticide Spiked Plant Material. Plant it was determined that the draw rate of an average smoking
material was prepared by first placing approximately 8 grams device user was approximately 1.2 L/min.This draw rate was
of homogenized cannabis flower material into a 250 mL then used for all of the experiments by ensuring that the
round bottom flask and vortexed at 1200 rpm until the small vacuum was set to draw at a rate that yielded height in
non-leafy material fell to the bottom. This material was the water column corresponding to 1.2 L/min. This process
then separated and sifted over a rough screen to further was performed before,during, and after each experiment to
remove small non-leafy material. This process was repeated ensure the simulated inhalation flow rate was as consistent as
five times until the plant material was sufficiently cleared of possible.
fine material that might otherwise incur poor homogeneity
of pesticide distribution in the bulk of the material. 2.6.Smoking Procedure. The smoking procedure was carried
To the sifted plant material, a concentrated solution out by passing the flame of a disposable lighter over the
of pesticide mixture in methanol, prepared to contain plant material for three seconds at 15-second intervals while
0.730 mg/mL bifenthrin, 7.41 mg/mL diazinon, 4.37 mg/mL the vacuum was applied at 1.2 L/min. For each experiment,
paclobutrazol,and 6.18 mg/mL permethrin,was then added approximately 0.45 g of spiked cannabis was used. Aliquots
incrementally to the plant material. These concentrations from the gas wash bottles were taken after being shaken and
were selected to allow for full quantification of residues agitated to capture any condensate on the walls and stems of
captured in the gas wash bottle solutions.A total of 8.30 mL the wash bottles and measured with GC-MS. Samples were
of the pesticide mixture solution was added to 74860 g of then stored at —20°C in the absence of light. All glassware,
the material incrementally. Each increment was carried out tubing, and smoking devices were then washed thoroughly
by adding 1 mL of the solution drop-wise into a 250 mL with methanol and acetone between experiments.In the case
round bottom flask containing the plant material that was of the water pipe, water was used in the water chamber
then vortexed at 1300 rpm over a 2 minute period. After as per manufacturer's specifications, and when applicable,
4 Journal of Toxicology
TABLE 1:Calibration curves and goodness of fit values. TABLE 3:Recovery of pesticides in smoke condensate.
Range Raw plant Glass pipe Water pipe Sample/residue µg/gram plant %Recovery
Residue 8 material smoke P P
(µg/mL) matrix matrix smoke matrix Water pipe with filters
Diazinon 0.737-36.9 0.9994 0.9994 0.9997 Diazinon 589 t 31.0 0.08
Paclobutrazol 0.437-21.9 0.9994 0.9982 0.9999 Padobutrazol 420 t 32.5 10.2
Bifenthrin 0.072-3.62 0.9811 0.9998 0.9971 Bifenthrin 77 t 34.5 9.00
t
Permethrin 0.607-30.4 0.9915 0.9999 0.9999 Permethrin 685 34.9 10.9
Cotton filter
TABLE 2:Spiked plant material extractions. Diazinon 190 i 11.0 24.9
Padobutrazol 109 3 8.80 30.1
Pesticide µg/gram Plant Bifenthrin 20.8 t 9.16 26.6
Spiked plant material Permethrin 134 3 8.52 25.1
Diuinon 6950 t 5.88 Carbon filter N/A N/A
Padobutrazol 4120 t 4.46 Water pipe w/out filters
Bifenthrin 855 3 3.63
Permethrin 6270 t 4.69 Diazinon 2930 3 15.1 42.2
Data presented as mean µg pesticide/gram plant material t relative standard Padobutmol 2040 t 11.3 49.5
deviation.Sample size of 3 for a0 measurements. Bifenthrin 389 t 10.1 45.4
Permethrin 3760 t 9.72 59.9
Glass pipe
7.5 g of virgin coconut carbon was used in the carbon filter Diazinon 4270 t 12.3 61.5
cartridge,while 0.7 g of cotton was used in the cotton filter
cartridge.After each experiment using the filtered device,the Padobutrazol 2789 t 13.8 67.4
cotton and carbon were extracted with 15 mL of analytical Bifenthrin 516 3 12.8 60.3
grade methanol and measured by GC-MS.Experiments were Permethrin 4360 t 9.70 69.5
carried out in triplicate for each device. Data presented as mean pg pesticide/gram plant material t relative standard
deviation.Sample size of 3 for all measurements.
2.7 Preparation of Calibration Curves. Three sets of cali-
bration curves were prepared, each in different matrixes
that consisted of smoked plant material solutions in order Pesticide recovery in smoke condensate(%)
to account for possible ion suppression from the matrixes. 80
All matrixes and plant material samples were ensured to 70
be free of the pesticides of interest before use and further 60
analysis.For the preparation of the raw plant material matrix, R 50
approximately 4 g of unspiked cannabis plant material from
the same source as that which was spiked was extracted with 40 ....
100 mL of analytical grade methanol and stirred with a stir a 30
bar for 20 minutes,followed by filtration through a Buchner 20
funnel. Smoke condensate matrixes from the glass pipe and 10
the water pipe were prepared by running the experiment o . . .
AN .
with each device as described in Section 2.6 and storing the Filtered water Nonfiltered Glass pipe
solutions in a dark container at-20`C before analysis. Each pipe water pipe
of these matrix solutions was then used to dilute the stock smoking device
solutions of pesticides for generating calibration curves in a Diazinon ■ Padobutrazol
each matrix. ■ Bifenthrin ■ Permethrin
FIGURE 1:Percent recovery ofpesticides from the smoke stream from
3.Results each device.
The calibration solutions of chemical residues were prepared
in the three separate matrixes and the calibration curves
generated are tabulated in Table 1.Table 2 presents the them- first wash bottle,representing excellent recovery capabilities.
ical residue content of the spiked plant material. Chemical In all three experiments, the recovery of chemical residues
residues recovered from the smoking devices are tabulated from the activated charcoal was below the lowest calibration
in Table 3, as well as the percent recovery with respect to level and is therefore not reported. Figure 1 illustrates the
the spiked plant material.It should be noted that 97%of the comparative recovery of chemical residues from each of the
recovered residue in the gas wash bottles was found in the smoking devices.
Journal of Toxicology 5
4. Discussion volatilization characteristics,and to what extent degradation
occurs during heating and combustion of the plant material
The relative amounts of pesticide residues present in other surface.
smoked plant material, most notably tobacco, have been It should be noted that different levels of pesticides
studied to determine the amount present in raw plant present on different varietals of cannabis flowers present
material, as well as the levels of transfer into the smoke different matrixes that may impact the amount of pesticides
stream.These results have been used to help guide regulations potentially being inhaled. Different user behaviors including
on pesticide application on tobacco crops and reduce the depth of breath,length of inhalation hold time,and choice of
potentials of pesticide toxicity in consumers [9, 12, 131. As
medical cannabis patients already possess negative health heating method may also impact overall individual exposure
complications,exposure to pesticides may create additional amounts. In our lab we use validated methods to detect
health complications and interfere with other health care Pesticides above EPA-based acceptable daily intake levels for
approaches. In addition, the awareness of proper and safe a 40 Kg individual consuming 10 g of flower material per day.
pesticide use and application is very important to any crop While these limits represent residues on plant material at
that will be consumed, especially one that will be inhaled. levels lower than the levels utilized in this study, a number
Understanding to what extent chemical residues may be of samples seen have failed considerably further supporting
consumed by the user of the final product is important,but previous findings by local authorities [4].Additional efforts
also improper applications of pesticides on cannabis crops are ongoing to quantify the amount of pesticides being
may lead to other contingencies such as applicator expo- detected in contaminated medical cannabis products.
sure and environmental contamination. To bring attention
to the importance of pesticide awareness and to further S. Conclusion
the regulatory efforts for both the medical cannabis and
impending recreational cannabis supplies,the present study The present study dearly demonstrates that chemical residues
demonstrates quantitatively the potential for pesticides to be present on cannabis will directly transfer into the mainstream
transferred into the smoke stream under the conditions often smoke and ultimately the end user. Recoveries occurred in
encountered by cannabis users.While the variance between the highest quantity with the hand-held glass pipe, ranging
triplicate samples was notable, when considering the vast between 60.3% and 69.5%. Recovery from the unfiltered
number of variables including heating conditions,and other water pipe ranged between 42.2% and 59.9%, and recovery
inherent variations,the overall variation was fairly minimal. from the filtered water pipe ranged between 0.08%and 10.9%.
From the data presented here,the recoveries of pesticide As mentioned previously,the effects of filtration have a sig-
residues in the smoke stream are very significant in relation nificant impact on the total residues consumed.While there
to the potential of exposure by the end consumer.A previous are differences between the devices,in general the portion of
study with filtered tobacco cigarettes published by Cai et al. pesticide recovery is alarmingly high and is a serious concern.
[9]noted that the range of pesticide recovery from the smoke Although pesticides are designed to degrade fairly quickly in
stream was 2 to 16%.The range of pesticide residue recovery the environment [14],it is evident from this study that some
in that study was comparable to the water pipe with filters are highly resistant to pyrolysis and volatilize easily into the
(0.08-10.9%)used in the present study,but without filters the smoke stream in agreement with previous studies noting the
recovery from the present study was much higher as evident distillation behavior of pesticides in mainstream smoke [7).
in Table 3 and Figure 1.This suggests that the cotton filters in Considering these results, high pesticide exposure through
a cigarette or water pipe are critical in capturing and reducing cannabis smoking is a significant possibility,which may lead
pesticide residues in the mainstream smoke.Also,extractions to further health complications in cannabis consumers.This
of the cotton filters(Table 3) contained a significant portion revelation certainly confounds previous metastudies seeking
of the pesticides passed through the device. The carbon to determine the possible negative consequences associated
filter retained an insignificant amount of pesticides,but this with long-term cannabis use,as our experience with a breadth
may have been due to heating and desorption of retained of samples indicates a significant possibility that the negative
compounds during each use as this portion is closest to the consequences reported in these studies could have been the
plant material combustion point.Between the glass pipe and result from various chemical residue exposures resulting
the water pipe with no filters,the relative pesticide recovery from the use of unregulated product supply chains. As
was greater when the glass pipe was used. This difference more states legislate and regulate cannabis products,a strong
may be attributed to the comparable levels of surface area regulatory approach will help to reduce the potential public
for the residues to accumulate inside the device by conden- health and safety consequences from pesticide exposure.
sation, as well as factors such as total path length, smoke While it is fortunate that chemical residue recovery may be
stream total flow rate velocity,and the absolute temperatures minimized with smoke filtering,this only serves to improve
achieved in situ.Additionally,the water pipe contained room consumer safety today with no adequate regulations,as there
temperature water that aids in cooling the smoke stream is no better way to avoid pesticide and other chemical residue
before exiting the device. Comparative recoveries between consumption than to assure it is not present on the product in
individual pesticides (Figure 1) show significant differences the first place.Active sampling and analytical monitoring of
in the recovery of each pesticide. These differences may be the cannabis supply,along with collaborative efforts between
attributed to the variations in stability of each compound, current patients and state regulatory authorities,are needed
6 Journal of Toxicology
to help further guide the development and implementation [141 S.W.Purkis,C.Muellerb,and M.Intorp,"The fate of ingredients
of proper application methods and testing standards that will in and impact on cigarette smoke,"Food and Chemical Toxicol-
avoid environmental contamination and consumer threats to ogy,vol.49,no.12,pp.3238-3248,2011.
public health and safety.
Conflict of Interests
The authors declare that they have no conflict of interests.
Acknowledgments
The authors would like to gratefully thank the team members
of Scientific Inhalations for all of their collaborative effort
and support. They would also like to thank the Pasadena
Area Community College District for their grant support of
Nicholas Sullivan's internship.
References
[1] Congress of the United Statesm,Office of Technology Assess-
ment,Pesticide Residues in Food,Library of Congress,Washing-
ton,DC,USA,1988.
[21 J. B. Stephenson, "U.S. GAO. Pesticides on Tobacco: federal
activities to assess risk and monitor residues;' GAO-03-485,
United States Government Printing Office, Washington, DC,
USA,2003.
[31 J Tbomson,"Medical Marijuana Cultivation and Policy Gaps,"
California Research Bureau,2012.
[41 N.Skeet,"City Attorney Explains Medical Marijuana Issue on
NBC,http://Iacityorgattyblogspot.com/2009/10/city-attorney-
explains-medical.html,2009.
[51 L. J. Tadeo, Analysis of Pesticides in Food and Environmental
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[6) J.M.McPartland and P.L.Pruitt,"Medical marijuana and its use
by the immunocompromised,Alternative Therapies in Health
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[71 W.Lorenz,M.Bahadir,and E Korte,"Thermolysis of pesticide
residues during tobacco smoking"Chemosphere,vol.16,no.2-
3,pp.521-522,1987.
[8] M.Hashibe,H.Morgenstern,Y.Cui et al.,"Marijuana use and
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Biomarkers and Prevention,vol.15,no.10,pp.1829-1834,2006.
[91 J.Cal,B.Liu,X.Zhu,and Q.Su,"Determination of pyrethroid
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205-211,2002.
[101 P J. O'Connor-Mazer, The Safe and Effective Use of Pesticides,
Universityof California,Berkeley,Calif,USA,2nd edition,1999.
[111 P. J. Landrigan, K. E. Powell, L. M. James, and P R. Tay-
lor,"Paraquat and marijuana: epidemiologic risk assessment;'
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1983.
[121 R.E,Fresenius,Analysis of tobacco smoke condensate"Journal
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[13] C.J.Smith and C.Hansch,"The relative toxicity of compounds
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EXHIBIT `B"
INSURANCE PROVISIONS
Including Verification of
Coverage, Sufficiency of
Insurers,
Errors and Omissions Coverage,
Minimum Scope of Insurance,
Deductibles and Self-Insured Retentions, and
Severability of Interests (Separation of Insureds)
13
INSURANCE
1. Procurement and Maintenance of Insurance. Consultant shall procure and
maintain public liability and property damage insurance against all claims for injuries against
persons or damages to property resulting from Consultant's performance under this Agreement.
Consultant shall procure and maintain all insurance at its sole cost and expense, in a form and
content satisfactory to the City, and submit concurrently with its execution of this Agreement.
Consultant shall also carry workers' compensation insurance in accordance with California
workers' compensation laws. Such insurance shall be kept in full force and effect during the
term of this Agreement, including any extensions. Such insurance shall not be cancelable
without thirty (30) days advance written notice to City of any proposed cancellation. Certificates
of insurance evidencing the foregoing and designating the City, its elected officials, officers,
employees, agents, and volunteers as additional named insureds by original endorsement shall be
delivered to and approved by City prior to commencement of services. The procuring of such
insurance and the delivery of policies, certificates, and endorsements evidencing the same shall
not be construed as a limitation of Consultant's obligation to indemnify City, its elected officials,
officers, agents, employees, and volunteers.
2. Minimum Scope of Insurance. The minimum amount of insurance required
under this Agreement shall be as follows:
1. Comprehensive general liability and personal injury with limits of at least
one million dollars ($1,000,000.00) combined single limit coverage per occurrence and two
million dollars ($2,000,000) general aggregate;
2. Automobile liability insurance with limits of at least one million dollars
($1,000,000.00) per occurrence;
3. Professional liability (errors and omissions) insurance with limits of at least
one million dollars ($1,000,000.00) per occurrence and two million dollars ($2,000,000) annual
aggregate is:
required
_❑ is not required;
4. Workers' Compensation insurance in the statutory amount as required by the
State of California and Employer's Liability Insurance with limits of at least one million dollars
$1 million per occurrence. If Consultant has no employees, Consultant shall complete the City's
Request for Waiver of Workers' Compensation Insurance Requirement form.
3. Primary Insurance. For any claims related to this Agreement, Consultant's
insurance coverage shall be primary with respect to the City and its respective elected officials,
officers, employees, agents, and volunteers. Any insurance or self-insurance maintained by City
and its respective elected officials, officers, employees, agents, and volunteers shall be in excess
of Consultant's insurance and shall not contribute with it. For Workers' Compensation and
Employer's Liability Insurance only, the insurer shall waive all rights of subrogation and
14
contribution it may have against City, its elected officials, officers, employees, agents, and
volunteers.
4. Errors and Omissions Coveraee. If Errors & Omissions Insurance is required, and
if Consultant provides claims made professional liability insurance, Consultant shall also agree in
writing either (1) to purchase tail insurance in the amount required by this Agreement to cover
claims made within three years of the completion of Consultant's services under this Agreement,
or (2) to maintain professional liability insurance coverage with the same carrier in the amount
required by this Agreement for at least three years after completion of Consultant's services under
this Agreement. Consultant shall also be required to provide evidence to City of the purchase of
the required tail insurance or continuation of the professional liability policy.
5. Sufficiency of Insurers. Insurance required in this Agreement shall be provided by
authorized insurers in good standing with the State of California. Coverage shall be provided by
insurers admitted in the State of California with an A.M. Best's Key Rating of B++, Class VII, or
better, unless otherwise acceptable to the City.
6. Verification of Coveraee. Consultant shall furnish City with both certificates of
insurance and endorsements, including additional insured endorsements, effecting all of the
coverages required by this Agreement. The certificates and endorsements are to be signed by a
person authorized by that insurer to bind coverage on its behalf. All proof of insurance is to be
received and approved by the City before work commences. City reserves the right to require
Consultant's insurers to provide complete, certified copies of all required insurance policies at
any time. Additional insured endorsements are not required for Errors and Omissions and
Workers' Compensation policies.
Verification of Insurance coverage may be provided by: (1) an approved General and/or
Auto Liability Endorsement Form for the City of Palm Springs or (2) an acceptable Certificate of
Liability Insurance Coverage with an approved Additional Insured Endorsement with the
following endorsements stated on the certificate:
1. "The City of Palm Springs, its officials, employees, and agents are named as an
additional insured... " ("as respects City of Palm Springs Contract No. _"or 'for any and all
work performed with the City"may be included in this statement).
2. "This insurance is primary and non-contributory over any insurance or self-
insurance the City may have..." ("as respects City of Palm Springs Contract No. _" or 'for any
and all work performed with the City" may be included in this statement).
3. "Should any of the above described policies be canceled before the expiration date
thereof, the issuing company will mail 30 days written notice to the Certificate Holder named."
Language such as, "endeavor to" mail and "but failure to mail such notice shall impose no
obligation or liability of any kind upon the company, its agents or representative" is not
acceptable and must be crossed out.
15
4. Both the Workers' Compensation and Employers' Liability policies shall contain the
insurer's waiver of subrogation in favor of City, its elected officials, officers, employees, agents,
and volunteers.
In addition to the endorsements listed above, the City of Palm Springs shall be named the
certificate holder on the policies.
All certificates of insurance and endorsements are to be received and approved by the City before
work commences. All certificates of insurance must be authorized by a person with authority to
bind coverage, whether that is the authorized agentibroker or insurance underwriter. Failure to
obtain the required documents prior to the commencement of work shall not waive the
Consultant's obligation to provide them.
7. Deductibles and Self-Insured Retentions. Any deductibles or self-insured
retentions must be declared to and approved by the City prior to commencing any work or
services under this Agreement. At the option of the City, either (1) the insurer shall reduce or
eliminate such deductibles or self-insured retentions with respect to the City, its elected officials,
officers, employees, agents, and volunteers; or (2) Consultant shall procure a bond guaranteeing
payment of losses and related investigations, claim administration, and defense expenses.
Certificates of Insurance must include evidence of the amount of any deductible or self-insured
retention under the policy. Consultant guarantees payment of all deductibles and self-insured
retentions.
8. Severability of Interests (Separation of Insureds). This insurance applies
separately to each insured against whom claim is made or suit is brought except with respect to
the limits of the insurer's liability.
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