HomeMy WebLinkAbout06/03/2014 06 Audience Participation Distributed at the
i l 6
Y �� Overview ,1 Jedidoh 1
1 Key Features of Initiative 502
TO MARIJUANA
• It would no longer be a crime for adults 21 and over to possess up to one ounce of marijuana for personal use.
12000
") 10000
8000
6000
E 4000
I
2000
0
2°°° 2001
2002 2003
2004 2009 Misdemeanor Possessan Arrests
2006 2007 Felony Arrests (Growing, Sales)
2008 2009
2010
• Specially- licensed Washington farmers would be allowed to grow marijuana that could be sold in standalone,
marijuana -only package stores operated by private Washington businesses licensed and regulated by the state.
Public display, and smoking in bars or other locations where tobacco smoking is prohibited, would not be allowed.
Advertising and store locations would be restricted to minimize exposure to people under 21.
502 - Tax Revenue Distribution
Youth Drug
Prevention Public Health
According to the state Health Care ---$68 million Education
Office of Financial million
$244 million $44
I -502's new 25% marijuana Evaluation and
excise tax, combined with • Research
retail sales and B &O tax, $5 million
would generate more than
a half - billion dollars in new Program
tax revenue annually. Administration
Approximately $182 million $5 million
would go to the state
general fund, $34 million to Local Budgets
local budgets, and $366 $34 million
million to health care,
education, and prevention. State General
Fund
$182 million
• A new marijuana DUI standard would operate like Washington's alcohol DUI standard to discourage drivers who
might be over the limit from getting behind the wheel.
Updated 08.10.12 www.newapproachwa.org
J i
.I YES4 Backgrounder
1-502 Federal Law: Preemption and Dual Sovereignty
A NEW APPROACH
TO MARIJUANA
Initiative 502 is not preempted by federal law. On the other hand, it does not create a
legal defense to enforcement of federal marijuana laws. Rather, it represents a well -
considered, responsible approach to marijuana regulation that deserves the same policy
deference as state medical marijuana laws.
Washington is free to try a new approach to our marijuana laws.
• Our nation's structure, and the limits placed on federal power by the U.S. Constitution, "allow the
States 'great latitude under their police powers to legislate as to the protection of the lives, limbs,
health, comfort, and quiet of all persons." "'
• The powers reserved to the states by the U.S. Constitution include the power to decide what is
criminal and what is not under state law.'
• The reservation of powers to the states can foster innovation and positive change: "It is one of the
happy incidents of the federal system that a single courageous state may, if its citizens choose, serve
as a laboratory; and try novel social and economic experiments without risk to the rest of the
country.i
"Federal preemption" is a legal doctrine that says that any state law that
conflicts with a federal law is preempted, or "trumped" by the federal law.
• The Supremacy Clause of the U.S. Constitution says, 'This Constitution, and the Laws of the United
States ... shall be the supreme Law of the Land; and the Judges in every State shall be bound
thereby; any Thing in the Constitution or Laws of any State to the Contrary notwithstanding."
• The "Laws of the United States" are federal laws, like the federal Controlled Substances Act (CSA)
that prohibits marijuana. The "Laws of any State" are state laws like Washington's Uniform
Controlled Substances Act, which 1 -502 amends.
• Sec. 903 of the federal CSA specifically provides that federal drug laws do not preempt state drug
laws "unless there is a positive conflict" between the two. A "positive conflict" arises only if the
state law requires someone to do something that violates federal law.'
1 Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (internal citations omitted) (striking down a federal rule aimed at undermining
Oregon's Death with Dignity law).
2 See, e.g., Gonzales v. Raich, 545 U.S. 1, 42 (2005) (O'Connor, J., dissenting).
3 New State Ice Co. v. Liebmann, 285 U.S. 262, 311 (1932) (Brandeis, J., dissenting).
4 Article VI, Clause 2.
s 21 U.S.C. § 801 et seq.
6 RCW 69.50.101 et seq.
' Qualified Patients Ass'n v. City of Anaheim, 187 Cal. App. 4 734, 115 Cal. Rptr. 3d 89 (2010).
Updated 07.30.12 www.newapproachwa.org
lr.t a._on g NEW APPROACH TO MARIJUANA
1 -502 does not require anyone to do anything that violates federal law.
• 1 -502 removes state -law prohibitions against producing, processing, and selling marijuana, subject to
licensing and regulation by the Liquor Control Board. It also decriminalizes, under state law,
possession of limited amounts of marijuana by persons aged twenty -one and over. It does not
attempt to change federal penalties that apply to marijuana.
• A state may adopt regulations relating to marijuana that define the parameters of conduct that is
permissible under its own laws, and also create licensing systems that allow it to distinguish
between people engaged in permissible conduct and those who are breaking the law.'
• 1 -502 does not require anyone to produce, process, sell, or possess marijuana — or engage in any
other activity that is illegal under federal law. It simply removes state criminal and civil penalties for
marijuana - related activities that are conducted in compliance with state law, should a person
choose to engage in those activities.
"Dual sovereignty" is a legal principle that allows both the states and the
federal government to adopt laws relating to marijuana. Each sovereign is free
to enforce its own marijuana laws within the individual states — and also to
exercise discretion as to how and whether to enforce those laws.
• Both Congress and Washington State have adopted laws regarding marijuana. Those laws are
inconsistent in a number of areas, like sentencing and the medical use of marijuana. Someone who
grows marijuana in Washington is breaking both state and federal law, but the response by law
enforcement, and potential sentence one could face, are very different under the two sets of laws.
• The federal marijuana laws do not recognize medical use as a defense. However, in 1998,
Washington voters passed a medical marijuana law with 59% of the vote. In 2009, the U.S.
Department of Justice issued a memorandum to all U.S. Attorneys serving in medical marijuana
states that said that, as a policy matter, federal resources should not be expended on the
investigation and prosecution of individuals in "clear and unambiguous compliance" with state
medical marijuana laws.
• Marijuana produced, sold, and taxed under a robust regulatory system would protect public health
and safety much better than Washington's current unregulated medical marijuana market and the
black market supplying recreational users. Washington voters' decision to move in this direction
should receive the same deference as the medical marijuana laws already adopted by sixteen states
and Washington, D.C.
8 Initiative Measure No. 502 Ballot Measure Summary; 1 -502, Sec. 19.
9 1 -502 Ballot Measure Summary; 1 -502, Sec. 20.
10 Qualified Patients Ass'n, supra, n.5; County of San Diego, et al., v. San Diego NORML, et al., 165 Cal. App. 4 798, 81 Cal. Rptr. 3d
461, review denied (2008), and cert. denied, 556 U.S. ___, 129 S. Ct. 2380, 173 L. Ed. 2d 1293 (2009).
Green (/green) / Society (/society) Sign in 1 Register
• _f , •
4
iO
J�rr c .o,
000, } :14.i's f 0.
Y ti
•
41 , • t**
Argior 4011
A budtender pours marijuana from a jar at Perennial Holistic Wellness Center medical marijuana dispensary
in Los Angeles, California. Photo by David McNew /Getty
House blocks feds from going after medical marijuana
05/30/14 12:28 PM
5 save share 14 (http: /i
By Amanda Sakuma (/person /amanda - sakuma)
For the first time ever, Congress is taking action to protect - not condemn - medical marijuana
use.
Shortly after midnight Friday, the GOP -led House passed a measure
(http: / /www.huffingtonpost. com/ 2014 /05 /30 /dea- medical- marijuana - house-
vote_n_5414679.html) that would prohibit the Drug Enforcement Agency from raiding medical
marijuana activities in states where it is legal. It gained broad bipartisan support with 170
Democrats and 49 Republicans voting in favor of the bill, with a final 219 -189 tally
(http: / /clerk. house .gov /evs /2014/ro11258.xm1).
Republican Rep. Dana Rohrabacher of California attached the measure to a routine spending
bill. It would block the Justice Department from using federal dollars to interfere with medical
marijuana operations that are legal in almost half of states in the country.
'Sortie people are suffering, and if a doctor feels that he needs to prescribe something to
alleviate that suffering, it is immoral for this government to get in the way," Rohrabacher said,
raising his voice on the House floor Thursday night. "And that's what's happening."
The measure still faces several procedural hurdles. The Senate is expected to pass its own
funding bill, meaning the amendment would have to survive the reconciliation process in a
joint conference. And that's even before it makes it to the president's desk for his signature.
The groundbreaking vote mirrors a growing swell of support for marijuana across state
legislatures and among the public. For the first time ever, a majority of Americans support
Vmsnbc/ majority - americans - want- experiment)legalizing marijuana. Minnesota just became
the latest state to green -light medical use ( http: / /minnesota.cbslocal.com /2014/05/29/gov -
dayton- signs - medical- marijuana -bill- into -law /) of pot, adding to the 21 other states and the
District of Columbia that have similar laws on the books. Meanwhile Washington and
Colorado are becoming a testing ground in shaping a market and regulation for recreational
pot use while the drug remains illegal under federal law.
"Despite this overwhelming shift in public opinion, the federal government continues its hard
line of oppression against medical marijuana," Rohrabacher said on the House floor.
The feds have already taken small steps toward reconciling the competing state and federal
laws. Easing back on the decades -long "war on drugs," Attorney General Eric Holder said the
DOJ would stand by the voter - backed initiatives in Washington and Colorado. Holder has also
said the administration would be "glad to work with Congress" on whether to declassify
marijuana from being considered on the same level as heroin and LSD, a movement that is
slowly gaining steam (http://www.thefix.com / content / congressmen- ask- obama- declassify-
pot- schedule -i- drug).
"It's becoming clearer and clearer that marijuana prohibition's days are numbered," Marijuana
Policy Project director Dan Riffle said in a statement (http: / /www.mpp.org /media /press-
releases/ congress- votes -to- end - war - on.html). "It's nice to see more members of Congress
standing up for their constituents instead of standing in the way of reform."
Do you think recreational marijuana will be legal nationwide within the
next decade? (/msnbc /do -you- think - recreational- marijuana - will -be-
Iegal- nationwide - within- the - next - decade)
What do you think?
( http: / /pubads.g.doubleclick.net
/gampad /jump?
iu= 2620 /msnbc /poll &sz =240x
6/3/2014 Congressmen Ask Obama To Declassify Pot As Schedule I Drug 1 The Fix
the THE ANGELS HOUSE Luxurious Recovery of the body, mind & spirit.
fi ► Committed, Professional
• Luxurious & Comfortable Retreat
addiction and recovery, straight up as LALU NOW (714) 471 -4985 • Specialized Comprehensive Program
IiIr®
HOT TOPICS: Alcoholism Addiction AA Cocaine Heroin Get Your Weekly Email Fix Search ■
Congressmen Ask Obama To
Declassify Pot As Schedule 1 Drug MOST POPULAR
Spearheaded by Oregon congressman Earl Blumenauer, the letter marks the latest effort 1. AA Critic Lights Another Fire
by a growing number of politicians to make more sensible marijuana laws. 2. No Profit In Junkies, New Heroin
A bipartisan letter signed by 18 congressmen, 17 Vaccine Ignored
Democrats and one Republican is asking President ` r� 3. Film Starring Elle Fanning Shows
Obama to drop marijuana as a Schedule 1 drug. Its
' • +' Shocking Reality of Eating Disorders
current classification puts it on the same level as
4. Ester Nicholson Talks "Soul
heroin and LSD, which makes it impossible for Recovered"
doctors to prescribe it. .af" t 5. 35 Steps to Total Demoralization
i . '
a
The letter was composed by Rep. Earl Blumenauer • r _ '�
(D -Ore.) and said that urgent action was required of i . SOBER LIVING MORE
on this issue since Obama had recently told the
New Yorker that marijuana isn't any more From Steroid
/•. Madness to
dangerous than alcohol when it comes to "impact ByMcCartonAckerman Bantu Marijuana
+
on the individual consumer." 02/14/14 - ------- Sacred Bantu
1 Share marijuana was my
You said that you don't believe marijuana is any more dangerous than miracle MS healer —it
alcohol: a fully legalized substance...Marijuana, however, remains listed got diapers forced o func an b p out p t
on me and by y pr rescription
in the federal Controlled Substances Act at Schedule I, the strictest steroids.
Barack Obama Supports
classification. This makes no sense," the letter. "Classifying Marijuana Legalization In
marijuana as Schedule I at the federal level perpetuates an unjust and Colorado And Washington 35 Steps to Total Demoralization
irrational system. We believe the current system wastes resources and From Cold Turkey to Manorexia
White House Drug Official
destroys lives, in turn damaging families and communities. Taking Slammed For Refusing To I Don't Believe in God, But I Pray
action on this issue is long overdue." Say If Pot Is More Addictive My Name is Steven and I'm Not An
Than Meth Alcoholic
The letter also requested that marijuana be pushed further down than a Senate Majority Leader
Schedule II classification. Schedule I drugs are viewed by the federal Harry Reid Now Supports THE REHAB REVIEW
government as having "no currently accepted medical use in the United Medical Marijuana
States," while Schedule II are classified as having "a high potential for Congress Hopeful to Smoke Cliffside Malibu
abuse which may lead to severe psychological or physical Pot on Capitol Hill
dependence." Blumenauer has become a pot advocate as of late; he Rhode Island Lawmakers The "beach house - relaxed"
has pushed for tax reform to treat legal marijuana businesses like any Consider Legalizing Pot Cliffside Malibu claims to
pro' de an oasis for
other businesses and wants federal legislation to clarify the rights of recovenng addicts and alcoholics. And that's Just
states to legalize medical marijuana. what you'll get —if you've got the cash.
tr, //1' Morningside
Last week, Blumenauer - lammed the deputy director of the White House Office of National Drug I// Recovery
Control Policy after he refused to say whether pot was more dangerous than meth. Deputy director ',
Michael Botticelli acknowledged that "there's relative toxicity related to those drugs," but declined to say For a "rehab near the beach"
which was more harmful because he felt the conversation minimizes the harm." experience that isn't quite as
costly as similar SoCal competitors, head to this
Newport Beach treatment facility.
Blumenauer literally threw his hands up in frustration and ranted over what he felt was a vague
response. "Being unable to answer something clearly and definitively when there is unquestioned
evidence to the contrary, is why young people don't believe the propaganda, why they think it's benign,"
he said. "If a professional like you can't answer clearly that meth is more dangerous than marijuana —
http : / /www.thefixcorr'content/cong ressmen - ask - obama- declassify- pot - schedule -i -drug 1/3
f
Washington State
`_: Liquor Control Board
Washington State Liquor Control Board (WSLCB) Certification Good
Laboratory Practice (GLP) Checklist — Version 1.0
ORGANIZATON Document Y N NA Comments
Reference
1. The laboratory or the organization of which it is part
shall be an entity that can be held legally
responsible.
2. The laboratory conducting third -party testing shall
have no financial interest in a licensed producer or
processor for which testing is being conducted.
a. If the laboratory is part of an organization
performing activities other than testing and /or
calibration, the responsibilities of key personnel
in the organization that have an involvement or
influence on the testing and /or calibration
activities of the laboratory shall be defined in
order to identify potential conflicts of interest.
3. The laboratory shall have policies and procedures to
ensure the protection of its client's confidential
information and proprietary rights, including
procedures for protecting the electronic storage and
transmission of results.
4. The laboratory is responsible for all costs of initial
certification and ongoing site assessments.
5. The laboratory must agree to site assessments every
two years to maintain certification.
6. The laboratory must allow WSLCB staff or their
representative to conduct physical visits and check 1-
502 related laboratory activities at any time.
7. The laboratory must report all test results directly into
WSLCB's traceability system within 24 hours of
completion. Labs must also record in the traceability
system an acknowledgment of the receipt of samples
from producers or processors and verify if any
unused portion of the sample was destroyed or
returned to the customer.
1
HUMAN RESOURCES Document Y N NA Comments
Reference
8. Job Descriptions for Owners and all Employees: key
staff
9. Qualifications of Owners and Staff: CVs for staff on
file
a. Have technical management which has overall
responsibility for the technical operations and the
provision of the resources needed to ensure the
required quality of laboratory operations;
b. Documentation that the Scientific Director meets
the rule requirement of the WSLCB.
c. Chain of command, personnel organization /flow
chart, dated and signed by the laboratory director
d. Written Documentation of delegation of
responsibilities (assigned under rule of Chapter
314 -55 WAC as related to quality assurance
testing) to qualified personnel, signed and dated
by the laboratory director
e. Documentation of employee competency: Prior
to independently analyzing samples, testing
personnel must demonstrate acceptable
performance on precision, accuracy, specificity,
reportable ranges, blanks, and unknown
challenge samples (proficiency samples or
internally generated quality controls). Dated and
signed by the laboratory director.
f. Designate a quality manager (however named)
who, irrespective of other duties and
responsibilities, shall have defined responsibility
and authority for ensuring that the quality system
is implemented and followed; the quality
manager shall have direct access to the highest
level of management at which decisions are
made on laboratory policy or resources.
10. Written and documented system detailing the
qualifications of each member of the staff
a. The need to require formal qualification or
certification of personnel performing certain
specialized activities shall be evaluated and
implemented where necessary.
11. Standard Operating Procedure Manual that details
records of Internal Training Provided by Facility for
Staff: (Laboratory Director must approve, sign and
date each procedure)
a. Instructions on regulatory inspection and
preparedness
b. Instruction on law enforcement interactions
c. Information on U.S. federal laws, regulations,
and policies relating to individuals employed in
these operations, and the implications of these
for such employees.
2
HUMAN RESOURCES Document Y N NA Comments
Reference
d. Written and documented system of employee
Training on Hazards (physical and health) of
chemicals in the workplace, including prominent
location of MSDS sheets and the use of
appropriate PPE.
e. Written and documented system on the
competency of personnel on how to handle
chemical spills and appropriate action; spill kit on
site and well - labeled, all personnel know the
location and procedure.
f. Information on how employees can access
medical attention for chemical or other
exposures, including follow -up examinations
without cost or Toss of pay
g. Biosafety and sterile technique training
STANDARD OPERATING PROCEDURES Document Y N N/A Comments
Reference
12. As appropriate, Laboratory operations covered by
procedures shall include but not be limited to the
following:
a. Environmental, safety and health activities
b. Sample shipping and receipt
c. Laboratory sample chain of custody and
material control
d. Notebooks /logbooks
e. Sample storage
f. Sample preparation
g. Sample analysis
h. Standard preparation and handling
i. Post - analysis sample handling
j. Control of standards, reagents and water quality
k. Cleaning of glassware
i. Waste minimization and disposition
3
STANDARD OPERATING PROCEDURES Document Y N N/A Comments
Reference
13. The following information is required for procedures
as appropriate to the scope and complexity of the
procedures or work requested:
a. Scope (e.g. parameters measured, range,
matrix, expected precision, and accuracy)
b. Unique terminology used
c. Summary of method
d. Interferences /limitations
e. Approaches to address background corrections
f. Apparatus and instrumentation
g. Reagents and materials
h. Hazards and precautions
i. Sample preparation
j. Apparatus and instrumentation set -up
k. Data acquisition system operation
I. Calibration and standardization
m. Procedural steps
n. QC parameters and criteria
o. Statistical methods used
p. Calculations
q. Assignment of uncertainty
r. Forms used in the context of the procedure
FACILITIES AND EQUIPMENT Document Y N N/A Comments
Reference
14. Allocation of Space: adequate for number of
personnel and appropriate separation of work
areas
15. Arrangement of Space
a. Allows for appropriate work flow, sampling, lab
space separate from office and break areas;
b. Employee bathroom is separate from any
laboratory area
16. Adequate eyewash /safety showers /sink
17. Procurement Controls
a. The laboratory shall have procedure(s) for the
selection and purchasing of services and
supplies it uses that affect the quality of the
tests and /or calibrations. Procedures shall
exist for the purchase, receipt and storage of
reagents and laboratory consumable materials
relevant for the tests and calibrations.
b. The laboratory shall ensure that purchased
supplies and reagents and consumable
materials that affect the quality of tests and /or
calibrations are inspected or otherwise verified
as complying with standard specifications or
requirements defined in the methods for the
tests and /or calibrations concerned.
a. Prospective suppliers shall be evaluated and
selected on the basis of specified criteria.
4
FACILITIES AND EQUIPMENT Document Y N N/A Comments
Reference
b. Processes to ensure that approved suppliers
continue to provide acceptable items and
services shall be established and implemented.
c. When there are indications that subcontractors
knowingly supplied items or services of
substandard quality, this information shall be
forwarded to appropriate management for
action.
18. Utilities
a. Electrical
i. outlets: adequate, unobstructed, single
use, no multi -plug adaptors
ii. no extension cords
iii. Ground fault circuit interrupters near wet
areas
b. Plumbing
i. Appropriateness of sink usage: separate
for work/personal use;
ii. Adequate drainage from sinks, or floor
drains
iii. Hot and cold running water
c. Ventilation
i. Areas around solvent use or storage of
waste solvent
ii. Vented hood for any microbiological
analysis – Class II Type A biosafety
cabinet
d. Vacuum
i. appropriate utilities/ traps for prevention
of contamination
e. Shut -off controls: located outside of the
laboratory
19. Waste Disposal: appropriate for the type of waste
and compliant with WAC 314 -55 -097 Marijuana
waste disposal— Liquids and solids
20. Equipment List
a. Equipment and /or systems requiring periodic
maintenance shall be identified and records of
major equipment shall include:
i. Name
ii. Serial number or unique identification ,
iii. Date received and placed in service,
iv. Current location,
v. Condition at receipt,
vi. Manufacturer's instructions,
vii. Date of calibration or date of next
calibration,
viii. Maintenance
ix. History of malfunction.
21. Maintenance
5
FACILITIES AND EQUIPMENT Document Y N N/A Comments
Reference
a. Regular preventive maintenance of equipment
demonstration in log book including but not
limited to: thermometer calibration, pipette
calibrations, analytical balances, and analytical
equipment. Documentation of a schedule and
reviewed by the laboratory director.
b. Documentation of curative maintenance in log
book, signed and dated by laboratory director
c. Temperature maintenance log book for
refrigerators
d. Decontamination and cleaning procedures for:
i. instruments
ii. bench space
iii. ventilation hood
e. Documentation of adequacy of training of
personnel and responsibility for each
maintenance task
f. The organization shall describe or reference
how periodic preventive and corrective
maintenance of measurement or test
equipment shall be performed to ensure
availability and satisfactory performance of the
systems.
22. Computer Systems
a. Adequate for sample tracking
b. Adequate for analytical equipment software
c. Software control requirements applicable to
both commercial and laboratory developed
software shall be developed, documented, and
implemented.
d. In addition, procedures for software control
shall address the security systems for the
protection of applicable software.
e. For laboratory- developed software, a copy of
the original program code shall be:
i. Maintained,
ii. All changes shall include a description
of the change, authorization for the
change,
iii. Test data that validates the change
f. Software shall be acceptance tested when
installed, after changes, and periodically during
use, as appropriate.
g. Testing may consist of performing manual
calculations or checking against another
software product that has been previously
tested, or by analysis of standards.
h. The version and manufacturer of the software
shall be documented.
i. Commercially - available software may be
accepted as supplied by the vendor. For
vendor supplied instrument control /data
analysis software, acceptance testing may be
performed by the laboratory.
6
FACILITIES AND EQUIPMENT Document Y N N/A Comments
Reference
23. Security
a. Written facility security procedures during
operating and non - working hours.
b. Roles of personnel in security
c. SOP for controlled access areas and personnel
who can access
d. Secured areas for log -in of sample, and for
short and Tong -term storage of samples
24. Storage
a. Appropriate and adequate for sample storage
over time. The laboratory shall monitor, control
and record environmental conditions as
required by the relevant specifications,
methods and procedures or where they
influence the quality of the results. Due
attention shall be paid, for example, to
biological sterility, dust, electromagnetic
disturbances, humidity, electrical supply,
temperature, and sound and vibration levels,
as appropriate to the technical activities
concerned.
b. Adequate storage of chemical reference
standards
c. Appropriate Storage of any reagents: fire -proof
cabinet, separate cabinet for storage of any
acids.
d. Appropriate safe and secure storage of
documents etc., archiving, retrieval of,
maintenance of and security of data for a
period of three years.
QA PROGRAM and TESTING Document Y N N/A Comments
Reference
25. Sampling /Sample Protocols: Written and approved
by the laboratory director
a. Demonstrate adequacy of the Chain -of-
Custody tracking upon receipt of sample
including all personnel handling the sample.
b. Sampling method (representative of an entire
batch), including but not limited to
homogenization, weighing, labeling, sample
identifier (source, lot), date and tracking.
c. Condition of the Sample: Macroscopic and
foreign matter inspection — fit for purpose test.
Scientifically valid testing methodology: either
AHP monograph compliant, other third party
validation.
d. Failed inspection of product: tracking and
reporting
e. Return of failed product documentation and
tracking
f. Disposal of used /unused samples
documentation
7
QA PROGRAM and TESTING Document Y N N/A Comments
Reference
g. Sample preparation, extraction and dilution
SOP
h. Demonstration of recovery for samples in
various matrices (SOPs):
i. plant material - flower,
ii. edibles (solid and liquid meant to be
consumed orally),
iii. topical,
iv. concentrates
26. Data Protocols
a. Calculations for quantification of cannabinoid
content in various matrices - SOPs
b. Determination of the range for reporting the
quantity (LOD /LOQ) data review or generation
c. Reporting of Data: Certificates of Analysis
(CA)- Clear and Standardized format for
consumer reporting
d. Documentation that the value reported in the
CA is within the range and limitations of the
analytical method
e. Documentation that qualitative results (those
below the LOQ but above the LOD) are
reported as "trace ", or with a non - specific
(numerical) designation.
f. Documentation that the methodology has the
specificity for the degree of quantitation
reported. Final reports are not quantitative to
any tenths or hundredths of a percent.
g. Use of appropriate "controls ": documentation
of daily use of positive and negative controls
that challenge the linearity of the curve; and /or
an appropriate "matrix blank" and control with
documentation of the performance for each
calibration run.
27. Chemical Assay Procedure / Methodology
28. Proficiency:
a. Documentation of use of an appropriate internal
standard for any quantitative measurements as
applicable to the method
b. Appropriate reference standards for
quantification of analytes, performing and
documenting a calibration curve with each
analysis
c. Demonstration of calibration curve r2 value of
no Tess than 0.995 with a minimum of four
points within the range.
d. Documentation of any proficiency testing as it
becomes available. Laboratory director must
review, evaluate and report to the WSLCB any
result that is outside the stated acceptable
margin of error.
29. Method Validation: Scientifically valid testing
methodology: either AHP monograph compliant,
other third party validation or:
8
QA PROGRAM and TESTING Document Y N N/A Comments
Reference
30. Level 11 Validation of Methodology used for
quantification of THC, THCA and CBD for total
cannabinoid content (if reporting other
cannabinoids, the method must also be validated
for those compounds):
a. Single Lab Validation parameters are
demonstrated for GC, HPLC data review
i. linearity of reference standards
ii. use of daily standard curve;
iii. accuracy,
iv. precision,
v. Recovery (5 determinations not less than
90 %),
vi. reproducibility over time within a relative
standard deviation of 5 %;
b. Dynamic range of the instrumentation: Limits of
Quantification (LOQ) and Limits of Detection
(LOD)
c. Matrix extensions for each type of product
tested, data review of recovery for
i. solvent -based extract;
ii. CO2 extraction or other "hash oil ";
iii. extract made with food grade ethanol;
iv. extract made with food grade glycerin or
propylene glycol;
v. infused liquids;
vi. infused solids;
vii. infused topical preparations;
viii. other oils, butter or fats
d. Presence of QC samples and recording of daily
testing
e. Appropriate use of an internal reference
standard
f. Daily monitoring of the response of the
instrument detection system
31. Other Methods
a. Microbiological methods fit for purpose:
b. Microbial Contaminants within limits of those
listed in the most recent AHP monograph and
otherwise directed by WSLCB
c. Moisture Content Testing fit for purpose.
Scientifically valid testing methodology: either
AHP monograph compliant, other third party
validation.
d. Solvent Residuals Testing fit for purpose;
Solvent extracted products made with class 3
or other solvents used are not to exceed 0.5%
residual solvent by weight or 500 parts per
million (PPM) per one gram of solvent based
product and are to be tested.
e. Any other QA/QC methods is proven to be fit
for purpose
32. Laboratory Notebooks
a. Legible and in ink (or computerized system)
9
QA PROGRAM and TESTING Document Y N N/A Comments
Reference
b. Signed and dated
c. Changes initialed and dated
d. Periodically reviewed and signed by a
management representative
33. Preventive /Corrective Action
a. The laboratory shall have a process in place to
document quality- affecting
preventive /corrective actions through
resolution.
34. Periodic Management Review
a. Laboratory management shall periodically
review its quality system and associated
procedures to evaluate continued adequacy.
This review shall be documented.
10
Center for Laboratory Sciences
2710 North 20th Avenue, Pasco, WA 99301 '
A PARTNERSHIP WITH CBC Tel: (509) 545 -4989 I Fax: (509) 544 -6010
t
L aboratory
To Support WSLCB in Implementing
Initiative 502 and
WAC 314 ®55 -102
Jim Conca
Kris Kuhl - Klinger
Joe Sears
The Center for Laboratory Sciences on the
campus of Columbia Basin College
509 ®545 ®4989
Iabcertification@columbiabasin.edu
1
Center for Laboratory Sciences
2710 North 20th Avenue, Pasco, WA 99301
A PARTNERSHIP WITH CBC Tel: (509) 545 -4989 I Fax: (509) 544 -6010
�-r
P ro p osed Process
An r i p;
Center for Laboratory Sciences
2710 North 20th Avenue, Pasco, WA 99301
A PARTNERSHIP WITH CBC Tel: (509) 545 -4989 I Fax: (509) 544 -6010
•
Laboratory Certification
in support of 1 -502 (WAC- 314 -55 -102)
Lab begins
operations and
prepares for On-
Site Assessment
Yes °
Receive Lab ID ` Complete
Provisional
Apply and Complete st On -Site Operate
Granted?
Deliverables Asse
No
Lab prepares for
Ol Site
A
A Basic Overview of the Initial Certification Process 8
. ,
- -rte- f Center for Laboratory Sciences
41 •
2710 North 20th Avenue, Pasco, WA 99301
4 --! A PARTNERSHIP WITH CBC Tel (509) 545-4989 I Fax (509) 544-6010
,Att
Laboratory
Lab Completes 1-4 Notified of Status,
• Lal? N. gtifips ' • Documentation As with and
'w Sti-c of and Returns to ': Prepares for On-Site.,
Intent to Apply . •CPC-4.5 As5P,-rii.ent
,
WSLCB : --- ------ ---- ----- ,
E - Review With WSLCB
WSLCB Sends ,
,
.4p.,. Notice to
i RrOviSiPri4VNgn 7 .
CBC-C15 I , Provisional
Recommendation
1 ,
n
i ,,
,
CBC-CLS . CB-C1S Sgficls •
acknowledgement, •i C.,I3g reviews .
-,, . A0g9n,S I-Pb JP. PO
documentation and
issues tiPeciPd. For . schedules -Qn-51,t.q.
Assessment
Guidance to L.01? •
.
Initial certification in a bit more detail 9
Center for Laboratory Sciences
2710 North 20th Avenue, Pasco, WA 99301
A PARTNERSHIP WITH CBC Tel: (509) 545 -4989 I Fax: (509) 544 -6010
C onsiderations Imp
Provisional vs. Non - Provisional Laboratories
• Provisional Laboratory
— Operating as a business in Washington State;
— Has a QA program in place;
— Has the right people and credentials in place;
— Has the necessary instrumentation /equipment in place, and
— Can demonstrate acceptable performance through a combination of:
• Existing accreditations /certifications in 1 -502 specific areas
• Documented Demonstration of Capabilities
• Documented performance through other accreditations /certifications in
relevant technical areas
• Demonstration of capabilities through other means
A Laboratory designated and accepted as meeting Provisional status can be
allowed to proceed with testing provided an initial assessment is scheduled
within three months of application. 10
Center for Laboratory Sciences
` . 2710 North 20th Avenue, Pasco, WA 99301
A PARTNERSHIP WITH CBC Tel: (509) 545 -4989 I Fax (509) 544 -6010
Important Considerations - Continued
Provisional vs. Non- Provisional Laboratories
• Non - Provisional Laboratory
— Operating as a business in Washington State;
— Has a documented QA program in place;
— Has the right people and credentials in place;
— Has the necessary instrumentation /equipment in place, but
— Cannot demonstrate acceptable performance through a combination of:
• Existing accreditations /certifications in 1 -502 specific areas
• Documented Demonstration of Capabilities
• Documented performance through other accreditations /certifications in
relevant technical areas
• Demonstration of capabilities through other means
A Laboratory designated and accepted as meeting Non - Provisional status will not
be allowed to proceed with testing until an On -Site assessment is completed and
the Laboratory is determined to be competent to execute the work scope. 11
Center for Laboratory Sciences
2710 North 20th Avenue, Pasco, WA 99301
I A PARTNERSHIP 1 CBC Tel: (509) 545 -4989 I Fax: (509) 544 -6010
oar
Important Considerations - Continued
Regardless of Provisional /Non - Provisional Status
• All Labs must first be considered competent by the
WSLCB
— Subcontractor provides recommendation regarding overall
competency.
— The WSLCB determination can include other relevant
representatives or agencies in final determination.
12
Center for Laboratory Sciences
2710 North 20th Avenue, Pasco, WA 99301
A PARTNERSHIP WITH CBC Tel: (509) 545 -4989 I Fax: (509) 544 -6010
What a Lab Will Receive?
Acceptable Labs will Receive:
• An Initial On -Site Assessment Report
(completed checklist) and follow -on
acceptance of closure on any Findings
initiated /completed
• A letter signifying certification
— and a Field of Testing Summary that supports the
certificate.
13
Center for Laboratory Sciences
2710 North 20th Avenue, Pasco, WA 99301
A PARTNERSHIP WITH CBC Tel: (509) 545-4989 I Fax: (509) 544 -6010
Next Steps (Over Time)
Following Initial certification Labs will:
• Be- required to renew their status annually.
— Will use a modification to the Initial Application format.
• Be reassessed (On -Site Assessment) every two years.
• Be required to demonstrate acceptable, continued
performance in order to maintain certification
14status.
Note: Continuing Certification is not expected to entail as
much time as Initial Certification. Changes will be
made as the program continues to mature and more
lessons learned are gained.
14
. Center for Laboratory Sciences
2710 North 20th Avenue, Pasco, WA 99301
A PARTNERSHIP WITH CBC Tel: (509) 545 -4989 I Fax: (509) 544 -6010
Anticipated Costs for Certification
Washington State will invoice the applying Laboratory
• Initial Application: $2,667 (could lead to Provisional Status)
• Initial Site Assessment: two people for one day of on -site
auditing plus travel and per diem: $3,875
Total initial licensing effort is $2,667 + $3,875 = $6,542
• Annual Renewal Application: $1,667
• Subsequent bi- annual Site Assessments: One person for one
day of on -site auditing plus travel and per diem: $2,270
Total subsequent licensing effort is $1,667 and $3,937
alternating every other year
15
Center for Laboratory Sciences
2710 North 20th Avenue, Pasco, WA 99301
R A PARTNERSHIP WITH CBC Tel (509) 545 -4989 I Fax (509) 544 -6010
A
Anticipated Costs for Certification
1St Year 2 Year 3rd Year 4th Year
$6,542 $1,667 $3,937 $1,667
• If follow up to corrective action response is needed then
additional effort will be applied. This is typically 5 hours or
less.
• If very significant changes occur to the laboratory, personnel
or business, an additional site assessment may be required.
16