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Oregon Bulletin
August  1, 2016
Oregon Health Authority, Public Health Division, Chapter 333
Rule Caption: Standards for Reducing the Sale of Tobacco and Inhalant Delivery Systems to Minors
Adm. Order No.:  PH 19-2016
Filed with Sec. of State:  6-24-2016
Certified to be Effective:  6-24-16
Notice Publication Date:  4-1-2016
Rules Amended:  333-015-0200, 333-015-0205, 333-015-0210, 333-015-0215, 333-015-0220
Rules  Repealed:  333-015-0200(T),  333-015-0205(T),  333-015-0210(T),  333-015-0215(T),
333-015-0220(T)
Subject:  The  Oregon  Health  Authority  (Authority),  Public  Health  Division  is  permanently
ammending administrative rules in chapter 333, division 15 pertaining to standards for reducingthe sale of tobacco and inhalant delivery systems to minors. This permanent rulemaking will maketemporary rules effective January 1, 2016 through June 28, 2016 permanent.
 The permanent rules: 1. Create definitions in rules to reflect the purpose of the statute, and add clarity to the rules.
 2. Require tobacco and inhalant delivery system retailers to post a notice substantially similar to
the content of notice as defined in rules.
 3. Adds inhalant delivery systems to requirements specifying the location tobacco products within
a retail store.
 4. Add inhalant delivery systems to the Authority’s enforcement activities for implementing sales
to minors regulations.
Rules Coordinator:  Tracy Candela—(971) 673-0561
333-015-0200
Definitions
(1) “Authority” means the Oregon Health Authority.(2) “Block grant” means the Substance Abuse Prevention and Treatment Block Grant pursuant to
42 USC 300x21e et seq.
(3)(a) “Inhalant delivery system” means:(A) A device that can be used to deliver nicotine or cannabinoids in the form of a vapor or aerosol
to a person inhaling from the device; or
(B) A component of a device described in this subsection or a substance in any form sold for the
purpose of being vaporized or aerosolized by a device described in this subsection, whether thecomponent or substance is sold separately or is not sold separately.
(b) Inhalant delivery system does not include:(A) Any product that has been approved by the United States Food and Drug Administration for
sale as a tobacco  cessation product or for any other therapeutic purpose, if  the product ismarketed and sold solely for the approved purpose; andOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
1 of 100 8/11/2016 2:13 P M
(B) Tobacco products.
(4) “Minor” means an individual under 18 years of age.(5) “Outlet” means any location which sells at retail or otherwise distributes tobacco products or
inhalant delivery systems to  consumers including, but not limited to, locations that sell suchproducts over the counter or through vending machines.
(6) “Secretary” means the Secretary of  the United States Department of  Health and Human
Services.
(7) “Smoking instrument” means any cigar, cigarette, pipe or other instrument used to  smoke
tobacco, marijuana, cocaine or other inhalant as defined in ORS 433.835 and ORS 163.575.
(8) “Tobacco product” means bidis, cigars, cheroots, stogies, periques, granulated, plug cut, crimp
cut, ready rubbed and other smoking tobacco, snuff, snuff  flour, cavendish, shisha, hookahtobacco, plug and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps,clippings, cutting and sweepings of  tobacco  prepared in such a manner as to be suitable forchewing or smoking in a pipe or otherwise, or both for chewing and smoking, and cigarettes as
defined in ORS 431A.175.
(9) “Vending machine” means a mechanical, electronic or similar device that, upon the insertion of
tokens, money  or another form of  payment, dispense tobacco  products or inhalant deliverysystems as defined in ORS 167.402.
Stat. Auth.: ORS 431.853Stats. Implemented: ORS 431.853Hist.: PH 32-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16; PH 19-2016, f. & cert. ef.
6-24-16
333-015-0205Notice Posting Requirement
(1) An outlet must post a notice substantially similar to the notice described in section (2) of this
rule in a location that is clearly visible to the seller and the purchaser.
(2) Content of  the Notice: NOTICE: The sale of  tobacco products, smoking instruments and
inhalant delivery systems to persons under 18 years of age is prohibited by law. Any person whosells, or allows to be sold, a tobacco product, smoking instrument or inhalant delivery system to aperson under 18 years of age is in violation of Oregon law.
(3) The Authority may impose a civil penalty for each violation of this rule that is not less than
$250 or more than $1,000.
Stat. Auth.: ORS 431.840, 431.845Stats. Implemented: 431.840, 431.845Hist.: PH 32-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16; PH 19-2016, f. & cert. ef.
6-24-16
333-015-0210
Location of Tobacco Products Within a Retail Store
(1) A person having authority over the location of tobacco products or inhalant delivery systems in
a retail store may not locate the tobacco products or inhalant delivery systems in a location wherethe tobacco  products or inhalant delivery systems are accessible by store customers without
assistance by a store employee.
(2) This rule does not apply to a person if the location at which the tobacco products or inhalant
delivery systems are sold is a store or other establishment at which persons under 18 years ofage are prohibited.
Stat. Auth.: ORS 163.575, 167.400, 167.402, 167.407, 431.840, 431.853Stats. Implemented: ORS 431.853Hist.: PH 32-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16; PH 19-2016, f. & cert. ef.
6-24-16
333-015-0215EnforcementOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
2 of 100 8/11/2016 2:13 P M(1)  The  Authority  shall  coordinate  with  law  enforcement  agencies  to  conduct  random,
unannounced inspections of wholesalers and retailers of tobacco products, smoking instrumentsor inhalant delivery systems to ensure compliance with, and to enforce, the laws of this statedesigned to discourage the sale of tobacco products, smoking instruments and inhalant deliverysystems  to  minors.  Nothing  in  these  rules  shall  preempt  local  jurisdictions  from  passingordinances to conduct unannounced inspections.
(2)  Random  Sample  Procedures:  Random,  unannounced  inspections  will  be  based  on  the
following methodological procedures
(a) Cover a range of outlets, not to be preselected on the basis of prior violations, to measure
overall levels of compliance as well as to identify violations;
(b) Be conducted in such a way as to provide a probability sample of outlets in order to estimate
the success of enforcement actions being taken throughout the state;
(c) Use reliable methodological design and adequate sample design to reflect:(A) Distribution of the population of those under 18 throughout the state; and
(B) Distribution of outlets throughout the state that are accessible to minors; and
(d)  Be  conducted  at  times  when minors  are  likely  to  purchase  tobacco  products,  smoking
instruments or inhalant delivery systems.
(3) Targeted Inspections: The Authority may conduct targeted inspections of  outlets where a
compliance problem exists or is suspected. Information gained in targeted inspection will not beincluded in data used to determine rate of offense in random inspections.
(4) Conducting Inspections: Inspections may take place:
(a) Only in areas open to the public;
(b) Only during the hours that tobacco products, smoking instruments or inhalant delivery systems
are sold; and
(c) No more frequently than once a month in any single outlet unless a compliance problem exists
or is suspected. For purposes of this rule, a “single outlet” refers to a specific address location ofan outlet, regardless of ownership.
(5) The Authority may use minors to complete inspections to determine compliance with these
rules.
Stat. Auth.: ORS 431.853Stats. Implemented: ORS 431.853Hist.: PH 32-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16; PH 19-2016, f. & cert. ef.
6-24-16
333-015-0220
Annual Report
(1) Contents of Report: The Authority shall annually submit a report to the Oregon Legislature and
to the Secretary, along with the state’s application for block grant funding. The report shall include:
(a) A description of the state’s activities to enforce the laws described in OAR 333-015-0200
through OAR 333-015-0215 during the fiscal year preceding the fiscal year for which the state is
seeking the grant;
(b) A description outlining the overall success the state has achieved during the previous fiscal
year in reducing the availability of tobacco products, smoking instruments and inhalant deliverysystems to individuals under the age of 18, showing:
(A) Results of the random and targeted unannounced inspections;(B) Results of over-the-counter and vending machine outlet inspections reported separately;
(c) A description of how the unannounced inspections were conducted and the methods used to
identify outlets; and
(d) Strategies to be utilized by the state for enforcing such laws during the fiscal year for which the
grant is sought.
(2) Public Comment Required: The annual report shall be made public and public comment shall
be obtained and considered before submitting the report to the Secretary.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
3 of 100 8/11/2016 2:13 P MStat. Auth.: ORS 431.853
Stats. Implemented: ORS 431.853Hist.: PH 32-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-28-16; PH 19-2016, f. & cert. ef.
6-24-16
Rule Caption: Packaging and Labeling Requirements for Inhalant Delivery Systems
Adm. Order No.:  PH 20-2016
Filed with Sec. of State:  6-24-2016
Certified to be Effective:  6-24-16
Notice Publication Date:  4-1-2016
Rules Adopted: 333-015-0300,  333-015-0305,  333-015-0310,  333-015-0320,  333-015-0325,
333-015-0340,  333-015-0345,  333-015-0350,  333-015-0355,  333-015-0360,  333-015-0365,333-015-0370, 333-015-0375
Subject:  The  Oregon  Health  Authority,  Public  Health  Division  permanently  adopting
administrative rules in chapter 333, division 15 regarding packaging and labeling requirements forinhalant delivery systems.
 1. Creates definitions in rules to reflect the purpose of the statute, and add clarity to the rules. 2. Requires that inhalant delivery systems are not “Packaged in a manner attractive to minors,” as
defined in rules.
 3. Requires that inhalant delivery systems display l abels that conform to the labeling standards
set forth in 16 CFR 1700.20 and 21 CFR Parts 1100, 1140 & 1143.
 4. Establishes civil penalty amounts and enforcement schedule for violations of the rules.
Rules Coordinator:  Tracy Candela—(971) 673-0561
333-015-0300
Purpose, Scope and Effective Date
(1) The purpose of OAR 333-015-0305 to 333-015-0375 is to set the minimum standards for the
labeling and packaging of inhalant delivery systems that are sold to a consumer.
(2) These minimum standards are applicable on and after July 1, 2016.(3) These rules do not apply to an inhalant delivery system or prefilled inhalant delivery system
that contains cannabinoids if that inhalant delivery system or prefilled inhalant delivery systemcomplies with the packaging requirements in OAR 845-025-7000 to 845-025-7060 and the labelingrequirements in OAR 333-007-0010 to 333-007-0100.
Stat. Auth.: ORS 431A.175
Stats. Implemented: ORS 431A.175
Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0305
Definitions
For the purposes of OAR 333-015-0300 to 333-015-0375:(1) “Authority” means the Oregon Health Authority.(2)  “Cannabinoid”  means  any  of  the  chemical compounds  that  are  the  active  constituents  of
marijuana.
(3) “Cartoon” means any drawing or other depiction of an object, person, animal or creature or
any similar caricature that satisfies any of the following criteria:
(a) The use of exaggerated features;(b) The attribution of human characteristics to animals, plants or other objects, or the similar use
of anthropomorphic technique; orOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
4 of 100 8/11/2016 2:13 P M(c) The attribution of unnatural or extra-human abilities, such as imperviousness to pain or injury,
X-ray vision, tunneling at very high speeds or transformation.
(4) “Child-resistant” means packaging that is:(a) Intended to  protect  children from nicotine exposure in the household environment  or other
environment where the product is used;
(b) Designed or constructed to be significantly difficult for children under five years of age to open
and not difficult for adults to use properly, as defined by 16 CFR 1700.20 (1995); and
(c) Re-sealable for any product intended for more than a single use, such as a fillable inhalant
delivery system.
(5) “Consumer product” means any article, or component part thereof, produced or distributed for
sale to  a consumer for use in or around a permanent or temporary household or residence, aschool, in recreation, or otherwise, or for the personal use, consumption or enjoyment of  aconsumer in or around a permanent or temporary household or residence, a school, in recreation,or otherwise.
(6) “Distributor” means a person or company that supplies stores or businesses with goods.
(7) “Fillable inhalant delivery system” means a product that is sold without nicotine or non-nicotine
inhalants, not permanently sealed and can be opened and filled with any inhalant.
(8) “Inhalant” means nicotine, or any other substance that:(a) Is in a form that allows the nicotine, cannabinoid or substance to be delivered into a person’s
respiratory system;
(b) Is inhaled for the purpose of  delivering the nicotine, cannabinoid or other substance into  a
person’s respiratory system; and
(c)(A) Is not approved by, or emitted by a device approved by, the United States Food and Drug
Administration (FDA) for a therapeutic purpose; or
(B) If  approved by, or emitted by a device approved by, the United States Food and Drug
Administration for a therapeutic purpose, is not marketed and sold solely for that purpose.
(9)(a) “Inhalant delivery system” means:(A) A device that can be used to deliver nicotine or cannabinoids in the form of a vapor or aerosol
to a person inhaling from the device; or
(B) A component of a device described in this section or a substance in any form sold for the
purpose of  being vaporized or aerosolized by a device described in this section, whether thecomponent or substance is sold separately or is not sold separately.
(b)(A) Inhalant delivery system does not include any product that has been approved by the United
States Food and Drug Administration for sale as a tobacco cessation product or for any othertherapeutic purpose, if the product is marketed and sold solely for the approved purpose; and
(B) Tobacco products.
(10) “Inner package” means the package that must be opened by a consumer in order to have
access to the product and that may also be but is not required to be the outer package.
(11) “Liquid nicotine container” means a consumer product that consists of a container that:(a) Has an opening from which nicotine in a solution or other form is accessible and can flow
freely through normal and foreseeable use by a consumer; and
(b) Is used to hold soluble nicotine in any concentration.
(12) “Manufacturer or distributor contact information” means the name, city, state and country of
the manufacturer who made the inhalant delivery system.
(13) “Minor” means an individual under 18 years of age.(14) “Nicotine” means any form of the chemical nicotine, including any salt or complex, regardless
of whether the chemical is naturally or synthetically derived.
(15) “Non-nicotine liquid container” means a container that:
(a) Has an opening from which liquid non-nicotine or liquid non-cannabinoid substances can flow
freely through normal and foreseeable use by a consumer; andOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
5 of 100 8/11/2016 2:13 P M(b) Is not used to hold liquid nicotine or cannabinoids.
(16) “Outer package” means the external package visible to a consumer in the retail setting such
as, but not limited to, a box or container.
(17) “Outlet” means any location in Oregon which sells at retail or otherwise distributes tobacco
products or inhalant delivery systems to consumers including, but not limited to, locations that sellsuch products over the counter or through vending machines.
(18) “Packaged in a manner attractive to  minors” means an inhalant delivery system product
where any package, including the outer package or label on the outer package, or the inner
package or label on the inner package:
(a) Depicts cartoons;(b) Depicts celebrities or fictitious characters played by people;(c) Depicts people using the product;(d) Depicts food or beverage;
(e) Resembles any product of the type that is typically marketed to minors; or
(f) Resembles the shape of any animal, commercially recognizable toy or candy.(19) “Prefilled inhalant delivery system” means an inhalant delivery system that is permanently
sealed, prefilled, disposable and not intended to be disassembled by the consumer.
(20) “Retail setting” means a place of business in which merchandise is primarily sold directly to
an ultimate consumer.
(21) “These rules” means OAR 333-015-0300 to 333-015-0375.
Stat. Auth.: ORS 431A.175
Stats. Implemented: ORS 431A.175Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0310
Labeling Requirements for Liquid Nicotine Containers
A label on a liquid nicotine container must conform to the labeling standards set forth in 21 CFR
Parts 1100, 1140 and 1143.
Stat. Auth.: ORS 431A.175Stats. Implemented: ORS 431A.175
Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0320Labeling Requirements for Prefilled Inhalant Delivery Systems
A label on a prefilled inhalant delivery system must conform to the labeling standards set forth in
21 CFR Parts 1100, 1140 and 1143.
Stat. Auth.: ORS 431A.175Stats. Implemented: ORS 431A.175Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0325
Labeling Requirements for Fillable Inhalant Delivery Systems
A label on a fillable inhalant delivery system must conform to the labeling standards set forth in 21
CFR Parts 1100, 1140 and 1143.
Stat. Auth.: ORS 431A.175
Stats. Implemented: ORS 431A.175
Hist.: PH 20-2016, f. & cert. ef. 6-24-16Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
6 of 100 8/11/2016 2:13 P M333-015-0340
Packaging Requirements for Liquid Nicotine Containers
A liquid nicotine container for sale to a consumer:
(1) Must be:
(a) In child-resistant safety packaging; and(b) Labeled in accordance with these rules.(2) May not be placed in an inner or outer package that is attractive to minors.Stat. Auth.: ORS 431A.175Stats. Implemented: ORS 431A.175
Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0345Packaging Requirements for Non-nicotine Liquid Containers
A non-nicotine liquid container for sale to a consumer:
(1) Must be:(a) In child-resistant safety packaging; and(2) May not be placed in an inner or outer package that is attractive to minors.Stat. Auth.: ORS 431A.175Stats. Implemented: ORS 431A.175
Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0350Packaging Requirements for Prefilled Inhalant Delivery Systems
A prefilled inhalant delivery system for sale to a consumer:
(1) Must be labeled in accordance with these rules.(2) May not be placed in an inner or outer package that is attractive to minors.Stat. Auth.: ORS 431A.175Stats. Implemented: ORS 431A.175Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0355
Packaging Requirements for Fillable Inhalant Delivery Systems
(1) A fillable inhalant delivery system that is not packaged with a liquid nicotine container for sale
to a consumer:
(a) Must be labeled in accordance with these rules.(b) May not be packaged in any packaging, including an inner or outer package, that is attractive
to minors.
(2) A fillable inhalant delivery system that is packaged with a liquid nicotine container for sale to a
consumer must comply with OAR 333-015-0340.
Stat. Auth.: ORS 431A.175
Stats. Implemented: ORS 431A.175
Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0360
Verification of Child-Resistant PackagingOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
7 of 100 8/11/2016 2:13 P MOregon-based outlets must provide verification of  a manufacturer’s written laboratory testing
report describing child-resistant packaging results based on using the protocol set forth in 16 CFR1700.20 (1995) to the Authority upon the Authority’s request.
Stat. Auth.: ORS 431A.175Stats. Implemented: ORS 431A.175Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0365
Inspections
The  Authority  shall coordinate  random,  unannounced  inspections  of  Oregon-based  outlets  of
inhalant delivery systems to ensure compliance with these rules.
Stat. Auth.: ORS 431A.183
Stats. Implemented: ORS 431A.183Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0370
Violations
It is a violation for a manufacturer, retailer or distributor to:(1) Distribute, sell or allow to be sold an inhalant delivery device that does not comply with a
labeling requirement in OAR 333-015-0310 to 333-015-0030.
(2) Distribute, sell or allow to be sold an inhalant delivery device that does not comply with a
packaging requirement in OAR 333-015-0340 to 333-015-0360.
Stat. Auth.: ORS 431A.175, 431A.178Stats. Implemented: ORS 431A.175, 431A.178Hist.: PH 20-2016, f. & cert. ef. 6-24-16
333-015-0375
Civil Penalties
(1) The Authority may impose a civil penalty for each violation of 333-015-0340 to 333-015-0360
against a manufacturer, retailer or distributor according to the following schedule:
(a) $0 together with the issuance of a warning letter to the retailer for the first violation
(b) Minimum of $500 for the second violation within a 24-month period of the first violation.
(c) Minimum of $800 for the third violation within a 24-month period of the second violation.(d) Minimum of $2000 for the fourth violation within a 24-month period of the third violation.(e) Minimum of $8000 for the fifth violation within a 36-month period of the fourth violation.(f) Minimum of $15,000 for the sixth or subsequent violation within a 48-month period of the fifth
violation.
(2) A civil penalty may not to exceed $15,000 for each violation or $1,050,000 for all violations
found in a single inspection.
(3) Each product that does not comply with these rules or that is distributed, sold, or allowed to be
sold in violation of these rules is a separate violation. For example, if 10 liquid nicotine containersare distributed, sold, or allowed to be sold without child-resistant packaging the civil penalty couldbe $5000 (10 x $500).
Stat. Auth.: ORS 431A.178Stats. Implemented: ORS 431A.178
Hist.: PH 20-2016, f. & cert. ef. 6-24-16
Rule  Caption:  Marijuana  Labeling,  Concentration  Limits  and  Testing.  Medical  Marijuana  Growers,
Processors, Dispensaries and PatientsOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
8 of 100 8/11/2016 2:13 P MAdm. Order No.:  PH 21-2016
Filed with Sec. of State:  6-24-2016
Certified to be Effective:  6-28-16
Notice Publication Date:  5-1-2016
Rules Adopted: 333-007-0345
Rules Amended:  333-008-0010, 333-008-0020, 333-008-0021,  333-008-0022,  333-008-0023,
333-008-0025,  333-008-0033,  333-008-0037,  333-008-0040,  333-008-0045,  333-008-0080,333-008-0500,  333-008-0510,  333-008-0540,  333-008-0550,  333-008-0560,  333-008-1078,333-008-1110,  333-008-1190,  333-008-1200,  333-008-1205,  333-008-1225,  333-008-1230,
333-008-1245,  333-008-1610,  333-008-1620,  333-008-1650,  333-008-1670,  333-008-1690,
333-008-1710,  333-008-1720,  333-008-1730,  333-008-1740,  333-008-1760,  333-008-1770,333-008-1780,  333-008-1790,  333-008-1800,  333-008-1810,  333-008-1830,  333-008-2030,333-008-2080,  333-008-2090,  333-008-2100,  333-008-2110,  333-008-2180,  333-008-2190,333-008-0570,  333-008-0630,  333-008-1000,  333-008-1020,  333-008-1040,  333-008-1060,333-008-1070,  333-008-1075,  333-007-0010,  333-007-0020,  333-007-0030,  333-007-0040,333-007-0050,  333-007-0060,  333-007-0070,  333-007-0080,  333-007-0083,  333-007-0085,333-007-0090,  333-007-0100,  333-007-0200,  333-007-0210,  333-007-0220,  333-007-0300,
333-007-0310,  333-007-0315,  333-007-0320,  333-007-0330,  333-007-0340,  333-007-0350,
333-007-0360,  333-007-0370,  333-007-0380,  333-007-0390,  333-007-0400,  333-007-0410,333-007-0420,  333-007-0430,  333-007-0440,  333-007-0450,  333-007-0470,  333-007-0480,333-007-0490, 333-064-0100, 333-064-0110
Rules  Repealed:  333-008-1073,  333-008-1640,  333-007-0010(T),  333-007-0020(T),
333-007-0030(T),  333-007-0040(T),  333-007-0050(T),  333-007-0060(T),  333-007-0070(T),
333-007-0080(T),  333-007-0083(T),  333-007-0085(T),  333-007-0090(T),  333-007-0100(T),333-007-0200(T),  333-007-0210(T),  333-007-0220(T),  333-008-1225(T),  333-008-0300(T),333-008-0310(T),  333-007-0315(T),  333-007-0320(T),  333-007-0330(T),  333-007-0340(T),333-007-0350(T),  333-007-0360(T),  333-007-0370(T),  333-007-0380(T),  333-007-0390(T),333-007-0400(T),  333-007-0410(T),  333-007-0420(T),  333-007-0430(T),  333-007-0440(T),333-007-0450(T),  333-007-0460,  333-007-0470(T),  333-007-0480(T),  333-007-0490(T),333-064-0100(T), 333-064-0110(T)
Subject:  The Oregon Health Authority (OHA), Public Health Division is permanently adopting
amending and repealing rules in chapter 333, division 7, 8 and 64 related to marijuana productserving size and concentration limits, marijuana labeling and marijuana laboratory sampling andtesting; and pertaining to medical marijuana growers, processors, dispensaries and patient cards.
 House Bill 3400 (Oregon Laws 2015, chapter 614) made many changes to the Oregon Medical
Marijuana Act, including directing the Oregon Health Authority, in consultation with the Oregon
Liquor Control Commission (OLCC) and the Oregon Department of Agriculture (ODA), to protectpublic  safety  by  establishing  rules  on marijuana  laboratory  sampling  and  testing,  marijuanalabeling, marijuana product serving size and concentration limits.
 In order to protect public health and safety, these rules establish standards for the sampling and
testing  of  marijuana  items,  including,  but  not  limited  to,  tests  for  pesticides,  solvents,microbiological  contaminants,  and  tetrahydrocannabinol  and  cannabidiol  concentration.  Inaddition, the rules on testing establish sampling procedures for marijuana items and the reporting
of  test results. The rules establish labeling standards of  marijuana items ensuring that labels
include, among other things, health and safety warnings, product content, activation time, THCconcentration levels and laboratory testing information. The rules also  establish the maximumconcentration of THC that is permitted in a marijuana item or single serving of a marijuana item,and the number of servings permitted in a marijuana item.
 On and after October 1, 2016, all marijuana items sold in a medical marijuana dispensary or in a
retail establishment licensed by the OLCC will be required to meet these labeling, concentrationlimit and serving size standards established by the Authority.
 OLCC licenses will be required to comply with the sampling and testing requirements at all times.
 Changes  to  chapter  333,  division 8  of  the  Oregon Administrative  Rules  are  necessary  to
implement SB 1511, (Oregon Laws 2016, chapter 83), SB 1598 (Oregon Laws 2016, chapter 23)and HB 4014 (Oregon Laws 2016, chapter 24). In addition, certain housekeeping measures arenecessary for rules governing processors and dispensaries to more adequately reflect the intentof the rules that were filed on March 1, 2016. Revisions to these rules include, but are not limitedto, the following areas:
 -Fees for patient applicants who have served in the armed forces;
 -The residency requirements for persons responsible for marijuana grow sites (PRMG), persons
responsible for a dispensary, and persons responsible for a marijuana processing site;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
9 of 100 8/11/2016 2:13 P M -The issuance of a receipt to a patient applicant;
 -Requirements for Grandfathered grow sites; -Grow site plant limits; -Delegation of reporting and documentation requirements by a PRMG; -Land use compatibility statements from local governments; -Dispensary premises restrictions and requirements;
 -Transfers of marijuana by a patient or designated primary caregiver to a registered processing
site and transfers from a registered processing site to a patient or designated primary caregiver;
 -Required reporting by registered processing sites to the Authority; and -Security, camera and video requirements.
Rules Coordinator:  Tracy Candela—(971) 673-0561
333-007-0010
Purpose, Scope and Effective Date
(1) The purpose of OAR 333-007-0010 through 333-007-0100 is to set the minimum standards for
the  labeling  of  marijuana  items  that  are  sold to  a consumer,  patient  or designated  primary
caregiver. These minimum standards are applicable to:
(a) A Commission licensee as that is defined in OAR 845-025-1015; and(b) A person registered with the Authority under ORS 475B.400 to 475B.525 who is not exempt
from the labeling requirements as described in section (2) of this rule.
(2) The labeling requirements in these rules do not apply to:(a) A grower if the grower is transferring usable marijuana or an immature marijuana plant to:
(A) A patient who designated the grower to grow marijuana for the patient; or
(B) A designated primary caregiver of the patient who designated the grower to grow marijuana
for the patient.
(b) A designated primary caregiver of a patient if the caregiver is transferring a marijuana item to
a patient of the designated primary caregiver.
(3) Nothing in these rules prohibits the Commission or the Authority from:
(a) Imposing additional labeling requirements in their respective rules governing licensees and
registrants as long as those additional labeling requirements are not inconsistent with these rules;or
(b) Requiring licensees or registrants to provide informational material to a consumer, patient or
designated primary caregiver at the point of sale.
(4) A person licensed by the Commission must comply with these rules at all times.(5) On and after October 1, 2016:
(a) A marijuana item received or transferred by a dispensary must meet the labeling requirements
in these rules; and
(b) A dispensary may not transfer a marijuana item that does not meet the labeling requirements in
these rules.
(6) By October 1, 2016, a dispensary must:(a) Transfer marijuana items that do not meet the labeling requirements in these rules to a patient
or caregiver;
(b) Return any marijuana item that does not meet labeling requirements in these rules to  the
individual who transferred the item to the dispensary, and document who the item was returned to,what was returned and the date of the return; or
(c) Dispose of any marijuana item that does not meet labeling requirements and that cannot be
returned in accordance with subsection (b) of this section, in a manner specified by the Authority.
Stat. Auth.: ORS 475B.605Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
10 of 100 8/11/2016 2:13 P MStats. Implemented: ORS 475B.605
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 4-2016(Temp), f. & cert.
ef. 2-8-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-007-0020
Definitions
For the purposes of OAR 333-007-0100 through 333-007-0100, unless otherwise specified:(1) “Activation time” means the amount of time it is likely to take for an individual to begin to feel
the effects of ingesting or inhaling a marijuana item.
(2) “Authority” means the Oregon Health Authority.
(3) “Cannabinoid concentrate or extract” means a substance obtained by separating cannabinoids
from marijuana by a mechanical, chemical or other process.
(4)(a) “Cannabinoid edible” means:(A) Food or potable liquid into which a cannabinoid concentrate or extract or the dried leaves or
flowers of marijuana have been incorporated; or
(B)  For  purposes  of  labeling,  includes  any  cannabinoid  concentrate,  extract  or  cannabinoid
product that is intended for human consumption or marketed in a manner that implies the item is
for human consumption.
(b) For purposes of labeling “cannabinoid edible” does not include a cannabinoid tincture.(5)(a) “Cannabinoid product” means a cannabinoid edible or any other product intended for human
consumption or use, including a product intended to  be applied to  a person’s skin or hair, thatcontains cannabinoids or the dried leaves or flowers of marijuana.
(b) “Cannabinoid product” does not include:(A) Usable marijuana by itself;
(B) A cannabinoid concentrate or extract by itself; or
(C) Industrial hemp, as defined in ORS 571.300.(6) “Cannabinoid tincture” means a solution of  alcohol, cannabinoid concentrate or extract, and
perhaps other ingredients intended for human consumption or ingestion, and that is exempt fromthe Liquor Control Act under ORS 471.035.
(7) “Cannabinoid topical” means a cannabinoid product intended to be applied to skin or hair.(8) “CBD” means cannabidiol.
(9) “Commission” means the Oregon Liquor Control Commission.
(10) “Consumer” has the meaning given that term in ORS 475B.015 and does not include a patient
or designated primary caregiver.
(11) “Container”(a) Means a sealed, hard or soft-bodied receptacle in which a marijuana item is placed.(b) Does not mean inner wrapping or packaging that is not intended to display the marijuana item
for sale to a consumer.
(12) “Date of harvest” means the date the mature marijuana plants in a harvest lot were removed
from the soil or other growing media. If the harvest occurred on more than one day, the “date ofharvest” is the day the last mature marijuana plant in the harvest lot was removed from the soil orother growing media.
(13)  “Delta-9  THC”  is  the  principal  psychoactive  constituent  (the  principal  cannabinoid)  of
cannabis.
(14)(a) “Designated primary caregiver” means an individual:
(A) Who is 18 years of age or older;
(B) Who has significant responsibility for managing the well-being of  a person who has been
diagnosed with a debilitating medical condition; and
(C) Who is designated as the person responsible for managing the well-being of a person whoOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
11 of 100 8/11/2016 2:13 P Mhas been diagnosed with a debilitating medical condition on that person’s application for a registry
identification card or in other written notification submitted to the Authority.
(b) “Designated primary caregiver” does not include a person’s attending physician.(15) “Food” means a raw, cooked, or processed edible substance, or ingredient used or intended
for use or for sale in whole or in part for human consumption, or chewing gum.
(16) “Grower” has the same meaning as “person responsible for a marijuana grow site.”
(17) “Harvest lot” means marijuana that is uniform in strain, cultivated utilizing the same growing
practices and harvested at the same time.
(18) “Human consumption” means  to  ingest,  generally  through the mouth,  food,  drink or other
substances such that the substance enters the human body but does not include inhalation.
(19) “Licensee” has the meaning given that term in ORS 475B.015.(20) “Major food allergen” means an ingredient that is one of the five foods listed in subsections
(a) to (e) of this section, or from one of the three food groups listed in subsections (f) to (h) of thissection, or is an ingredient that contains protein derived from one of the following:
(a) Milk;
(b) Egg;(c) Fish;(d) Crustacean shellfish;(e) Tree nuts;(f) Wheat;
(g) Peanuts; and
(h) Soybeans.(21)(a) “Marijuana” means the plant Cannabis family Cannabaceae, any part of the plant Cannabis
family Cannabaceae and the seeds of the plant Cannabis family Cannabaceae.
(b) “Marijuana” does not include industrial hemp, as defined in ORS 571.300.(22) “Marijuana item” means marijuana, usable marijuana, a cannabinoid product, or a cannabinoid
concentrate or extract.
(23) “Medical grade cannabinoid product, cannabinoid concentrate or cannabinoid extract” means
a cannabinoid product, cannabinoid concentrate or cannabinoid extract that has a concentrationof THC that is permitted under ORS 475B.625 in a single serving of the cannabinoid product,cannabinoid concentrate or cannabinoid extract for a patient.
(24) “Medical grade symbol” means the image established by the Authority and made available to
licensees  indicating  the  cannabinoid  product,  concentrate  or  extract  may  only  be  sold  ortransferred to a designated primary caregiver or patient, for use only by a patient.
(25) “Medical marijuana dispensary” means a facility registered under ORS 475B.450.
(26) “Net weight” means the gross weight minus the tare weight of the packaging.(27) “Package  unique  identification number” mean the  unique  identification number that  was
generated by the Commission’s seed to sale tracking system at the time the marijuana item waspackaged and labeled for sale to the consumer, patient, or designated primary caregiver.
(28) “Patient” has the same meaning as “registry identification cardholder.”(29) “Person responsible for a marijuana grow site” means a person who has been selected by a
patient to produce medical marijuana for the patient, and who has been registered by the Authority
for this purpose and has the same meaning as “grower.”
(30) “Place of  address” means  the  name,  mailing  address,  city,  state and zip code  of  the
processor who made the cannabinoid edible.
(31) “Principal display panel” means the part of a label on a package or container that is most
likely to be displayed, presented, shown or seen under customary conditions of display for sale ortransfer.
(32) “Processor” means a person:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
12 of 100 8/11/2016 2:13 P M(a) Licensed by the Commission to process marijuana under ORS 475B.090; or
(b) Registered with the Authority under ORS 475B.435 as a processing site and who  is not
exempt from labeling requirements under ORS 475B.605
(33) “Process lot” means:(a) Any amount of cannabinoid concentrate or extract of the same type and processed at the
same time using the same extraction methods, standard operating procedures and batches fromthe same or different harvest lots; or
(b) Any amount of cannabinoid products of the same type and processed at the same time using
the same ingredients, standard operating procedures and batches from the same or differentharvest lots or process lots of cannabinoid concentrate or extract.
(34) “Producer” means a person:(a) Licensed by the Commission to produce marijuana under ORS 475B.070; and(b) Registered with the Authority under ORS 475B.420 as a grower and who is not exempt from
labeling requirements under ORS 475B.605.
(35) “Product identity” means a truthful or common name of  the product that is contained in the
package.
(36) “Registrant” means a person registered with the Authority under ORS 475B.400 to 475B.525.(37) “Registry identification cardholder” means a person to whom a registration card has been
issued under ORS 475B.415.
(38)(a) “Test batch” means a group of test samples that are collectively submitted to a laboratory
for testing purposes.
(b)  “Test  batch”  does  not  mean  a  combination  of  marijuana  flowers,  marijuana  leaves,
cannabinoid products, or cannabinoid concentrate or extract.
(39) “Test sample” means anything collected by an individual authorized by the Authority to collect
a sample from a licensee or registrant that is provided to a laboratory for testing, including but notlimited  to  marijuana  items,  soil,  growing  medium,  water,  solvent  or  swab  of  a  counter  orequipment.
(40) “THC” means tetrahydrocannabinol and has the same meaning as delta-9 THC.
(41) “These rules” means OAR 333-007-0010 through 333-007-0100.
(42) “Universal symbol” means the image, established by the Authority and made available to
licensees and registrants, indicating the marijuana item contains marijuana.
(43)(a) “Usable marijuana” means the dried leaves and flowers of marijuana.(b) “Usable marijuana” does not include:(A) The seeds, stalks and roots of marijuana; or
(B) Waste material that is a by-product of producing or processing marijuana.
Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0030
Marijuana Plant Labeling Requirements
Prior to a marijuana plant being sold or transferred to a consumer, patient or designated primary
caregiver a tag or label must be affixed to  the plant or plant container that has the followinginformation:
(1) Producer’s business or trade name and licensee or registrant number;
(2) Business or trade name of licensee or registrant that packaged or distributed the product, if
different from the producer;
(3) Name of the strain; andOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
13 of 100 8/11/2016 2:13 P M(4) Universal symbol.
Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0040
Marijuana Seed Labeling Requirements
Prior to a marijuana plant being sold or transferred to a consumer, patient or designated primary
caregiver a tag or label must be affixed to  the plant or plant container that has the followinginformation:
(1) Producer’s business or trade name and licensee or registrant number;
(2) Business or trade name of licensee or registrant that packaged or distributed the product, if
different from the producer;
(3) Name of the strain; and(4) Universal symbol.Stat. Auth.: ORS 475B.605
Stats. Implemented: ORS 475B.605
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0050
Usable Marijuana Labeling Requirements
Prior to usable marijuana being sold or transferred to a consumer, patient or designated primary
caregiver the container holding the usable marijuana must have a label that has the followinginformation:
(1) Producer’s business or trade name and licensee or registrant number;(2) Business or trade name of licensee or registrant that packaged or distributed the product, if
different from the producer;
(3) For licensees, package unique identification number and for registrants, harvest lot number;(4) Date of harvest;(5) Name of strain;(6) Net weight in U.S. customary and metric units;(7) Concentration of THC and CBD, as calculated under OAR 333-064-0100;
(8) Activation time expressed in words or through a pictogram;
(9) Name of  the lab that performed any test, any associated test batch number and any test
analysis date;
(10) Universal symbol;(11) For usable marijuana for sale to a consumer warnings that state:(a) “For use by adults 21 and older. Keep out of reach of children.”(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.” 
(12) For usable marijuana for use by a patient warnings that state:
(a) “For use by OMMP patients only. Keep out of reach of children.”(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.” Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
14 of 100 8/11/2016 2:13 P MHist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0060
Cannabinoid Topical Labeling Requirements
Prior  to  a  cannabinoid  topical  product  being  sold  or  transferred  to  a  consumer,  patient  or
designated primary caregiver the container holding the cannabinoid product must have a label thathas the following information:
(1) Processor’s business or trade name and licensee or registrant number;(2) Business or trade name of licensee or registrant that packaged or distributed the product, if
different from the processor;
(3) For licensees, package unique identification number and for registrants, process lot number;
(4) Product identity (common or usual name);(5) Date the product was made;(6) Net weight or volume in U.S. customary and metric units;(7) Amount suggested for use by the consumer or patient at any one time;(8) Concentration or amount by weight or volume of THC and CBD in the container;
(9) List of ingredients in descending order or predominance by weight or volume used to process
the cannabinoid topical;
(10) Activation time, expressed in words or through a pictogram;(11) Name of the lab that performed any test, any associated test batch number and any test
analysis date;
(12) Universal symbol;(13) For licensees, a medical grade symbol if applicable;
(14) A statement that reads: “This product is not approved by the FDA to treat, cure, or prevent
any disease”;
(15) For cannabinoid topicals for sale to a consumer warnings that state:(a) “For use only by adults 21 and older. Keep out of reach of children.”(b) “DO NOT EAT” in bold, capital letters.(16) For cannabinoid topicals for use by a patient warnings that state:
(a) “For use by OMMP patients only. Keep out of reach of children.”
(b) “DO NOT EAT” in bold, capital letters.Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0070
Cannabinoid Edible Labeling Requirements
Prior to  a cannabinoid edible being sold or transferred to  a consumer, patient or designated
primary caregiver the container holding the edible must have a label that has  the following
information:
(1) Processor’s business or trade name, place of address, and licensee or registrant number;(2) Business or trade name and place of  address of  licensee or registrant that packaged or
distributed the product, if different from the processor;
(3) Product identity (common or usual name);(4) For licensees, package unique identification number and for registrants, process lot number;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
15 of 100 8/11/2016 2:13 P M(5) Date the edible was made;
(6) Net weight or volume in U.S. customary and metric units;(7) Serving size and number of servings per container;(8) Concentration or amount by weight or volume of THC and CBD in each serving and in each
container;
(9) List of  all ingredients in descending order of  predominance by weight or volume used to
process the cannabinoid edible;
(10) List of potential major food allergens:(a) Using a “contains” statement to summarize the major food allergen information at the end of
or immediately adjacent to the ingredient list; or
(b) Placing the term for the appropriate major food allergen in parenthesis within the ingredient list
after the common or usual name of the ingredient derived from that major food allergen;
(11) The amount, in grams, of sodium, sugar, carbohydrates and total fat per serving;
(12) If the edible is perishable, a statement that the edible must be refrigerated or kept frozen;
(13) Name of the lab that performed any test, any associated test batch number and any test
analysis date;
(14) Activation time, expressed in words or through a pictogram;(15) Universal symbol;(16) For licensees, a medical grade symbol if applicable;(17) A statement that reads: “This product is not approved by the FDA to treat, cure, or prevent
any disease”;
(18) For cannabinoid edibles for sale to a consumer warnings that state:(a) “For use only by adults 21 and older. Keep out of reach of children.”(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.”(c) “BE CAUTIOUS” in bold, capital letters, followed by “Cannabinoid edibles can take up to 2
hours or more to take effect.”
(19) For cannabinoid edibles for use by a patient warnings that state:
(a) “For use by OMMP patients only. Keep out of reach of children.”(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.” (c) “BE CAUTIOUS” in bold, capital letters, followed by “Cannabinoid edibles can take up to 2
hours or more to take effect.”
Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0080
Labeling Requirements for Cannabinoid Concentrates and Extracts
Prior to a cannabinoid concentrate or extract being sold or transferred to a consumer, patient or
designated primary caregiver the container holding the concentrate or extract must have a labelthat has the following information:
(1) Processor’s business or trade name and licensee or registrant number;(2) Business or trade name of licensee or registrant that packaged or distributed the product, if
different from the processor;
(3) For licensees, package unique identification number and for registrants, process lot number;
(4) Product identity (concentrate or extract);Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
16 of 100 8/11/2016 2:13 P M(5) Date the concentrate or extract was made;
(6) Net weight or volume in U.S. customary and metric units;(7) If applicable, serving size and number of servings per container or amount suggested for use
by the consumer or patient at any one time;
(8) Concentration or amount by weight or volume of THC and CBD in each amount suggested for
use and in the container;
(9) Activation time, expressed in words or through a pictogram;
(10) Name of the lab that performed any test, any associated test batch number and any test
analysis date;
(11) Universal symbol;(12) For licensees, a medical grade symbol if applicable;(13) A statement that reads: “This product is not approved by the FDA to treat, cure, or prevent
any disease”;
(14) For cannabinoid concentrates and extracts for sale to a consumer warnings that state:
(a) “For use only by adults 21 and older. Keep out of reach of children.”(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.”(c) “DO NOT EAT” in bold, capital letters.(15) For cannabinoid concentrates and extracts for use by a patient warnings that state:(a) “For use by OMMP patients only. Keep out of reach of children.”(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.” 
(c) “DO NOT EAT” in bold, capital letters.
Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0083
Cannabinoid Tincture Labeling Requirements
Prior to a cannabinoid tincture being sold or transferred to a consumer, patient or designated
primary  caregiver  the  container  holding  the  tincture  must  have  a  label that  has  the  following
information:
(1) Processor’s business or trade name, place of address and licensee or registrant number;(2) Business or trade name and place of  address of  licensee or registrant that packaged or
distributed the product, if different from the processor;
(3) Product identity (common or usual name);(4) For licensees, package unique identification number and for registrants, process lot number;(5) Date the tincture was made;
(6) Net weight or volume in U.S. customary and metric units;
(7) Serving size and number of servings per container;(8) Concentration or amount by weight or volume of THC and CBD in each serving and in each
container;
(9) List of  all ingredients in descending order of  predominance by weight or volume used to
process the cannabinoid tincture;
(10) Name of the lab that performed any test, any associated test batch number and any test
analysis date;
(11) Universal symbol;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
17 of 100 8/11/2016 2:13 P M(12) For licensees, a medical grade symbol if applicable;
(13) Activation time expressed in words or through a pictogram;(14) A statement that reads: “This product is not approved by the FDA to treat, cure, or prevent
any disease”;
(15) For cannabinoid tinctures for sale to a consumer warnings that state:(a) “For use only by adults 21 and older. Keep out of reach of children.”
(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.”
(16) For cannabinoid tinctures for use by a patient warnings that state:(a) “For use by OMMP patients only. Keep out of reach of children.”(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.” Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0085Cannabinoid Products Other than Cannabinoid Edibles, Topicals, or Tinctures
Prior to a cannabinoid product other than a cannabinoid edible, topical or tincture being sold or
transferred to  a consumer, patient or designated primary caregiver the container holding theproduct must have a label that has the following information:
(1) Processor’s business or trade name and licensee or registrant number;(2) Business or trade name of licensee or registrant that packaged or distributed the product, if
different from the processor;
(3) Place of address for the processor and packager, if applicable;
(4) Product identity (common or usual name);
(5) For licensees, package unique identification number and for registrants, process lot number;(6) Date the product was made;(7) Net weight or volume in U.S. customary and metric units;(8) Serving size and number of servings per container;(9) Concentration or amount by weight or volume of THC and CBD in each serving and in each
container;
(10) List of all ingredients in descending order of predominance by weight or volume used to
process the cannabinoid product;
(11) Name of the lab that performed any test, any associated test batch number and any test
analysis date;
(12) Universal symbol;(13) For licensees, a medical grade symbol if applicable;
(14) Activation time expressed in words or through a pictogram;
(15) A statement that reads: “This product is not approved by the FDA to treat, cure, or prevent
any disease”;
(16) For cannabinoid products for sale to a consumer warnings that state:(a) “For use only by adults 21 and older. Keep out of reach of children.”(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.”
(17) For cannabinoid products for use by a patient warnings that state:
(a) “For use by OMMP patients only. Keep out of reach of children.”Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
18 of 100 8/11/2016 2:13 P M(b) “It is illegal to drive a motor vehicle while under the influence of marijuana.” 
Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0090
General Label Requirements; Prohibitions; Exceptions
(1) Principal Display Panel.(a) Every container that contains a marijuana item for sale or transfer to a consumer, patient or
designated primary caregiver must have a principal display panel, as that term is defined in OAR
333-007-0020.
(b) If a container is placed within packaging for purposes of displaying the marijuana item for sale
or transfer to a consumer, patient or designated primary caregiver, the packaging must have aprincipal display panel as that term is defined in OAR 333-007-0020.
(c) The principal display panel must contain the product identity, net weight, and universal symbol,
if applicable.
(d) If the product is a medical grade cannabinoid product, concentrate or extract processed by a
licensee the principal display panel must include the medical grade symbol.
(2) A label required by these rules must:(a) Be placed on the container and on any packaging that is used to display the marijuana item for
sale or transfer to a consumer, patient or designated primary caregiver.
(b) Comply with the National Institute of Standards and Technology (NIST) Handbook 130 (2016),
Uniform Packaging and Labeling Regulation, incorporated by reference.
(c) Be in no smaller than 8 point Times New Roman, Helvetica or Arial font;
(d) Be in English, though it can be in other languages; and(e) Be unobstructed and conspicuous.(3) A marijuana item may have one or more labels affixed to the container or packaging.(4) A marijuana item that is in a container that because of its size does not have sufficient space
for a label that contains all the information required for compliance with these rules:
(a) May have a label on the container that contains a marijuana item and on any packaging that is
used to  display the marijuana item for sale or transfer to  a consumer, patient or designated
primary caregiver that includes at least the following:
(A) Information required on a principal display panel, if applicable for the type of marijuana item;(B) Licensee or registrant business or trade name and licensee or registrant number;(C) For licensees, package unique identification number and for registrants, batch or process lot
number;
(D) Concentration of THC and CBD; and
(E) Required warnings; and
(b) Must include all other required label information not listed in subsection (4)(a) of this rule on an
outer container or package, or on a leaflet that accompanies the marijuana item.
(5) A marijuana item in a container that is placed in packaging that is used to display the marijuana
item for sale or transfer to a consumer, patient, or designated primary caregiver must comply withthe labeling requirements in these rules, even if the container qualifies for the exception undersection (4) of this rule.
(6) The universal symbol:
(a) Must be at least 0.48 inches wide by 0.35 inches high.(b) May only be used by licensees or registrants.(c) May be downloaded at www.healthoregon.org/marijuana.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
19 of 100 8/11/2016 2:13 P M(7) Medical grade symbol. The medical grade symbol must be at least 0.35 inches in diameter.
(8) A label may not:(a) Contain any untruthful or misleading statements including, but not limited to, a health claim that
is not supported by the totality of publicly available scientific evidence (including evidence fromwell-designed  studies  conducted  in  a  manner  which  is  consistent  with  generally  recognizedscientific  procedures  and  principles),  and  for which there  is  significant  scientific  agreement,among experts qualified by scientific training and experience to evaluate such claims; or
(b) Be attractive to minors, as that is defined in OAR 845-025-7000.
(9) A marijuana item that falls within more than one category, for example a product that is both a
cannabinoid concentrate and cannabinoid edible, must comply with the labeling requirements thatapply to  both categories, with the exception of  the “DO NOT  EAT” warning if  the product isintended for human consumption or the “BE CAUTIOUS” warning if the effects of the product arecustomarily felt immediately.
(10) The THC and CBD amount required to be on a label must be the value calculated by the
laboratory that did the testing in accordance with OAR 333-064-0100.
(11) If a marijuana item has more than one test batch number, laboratory, or test analysis date
associated with the marijuana item that is being sold or transferred, each test batch number,laboratory and test analysis date must be included on a label.
(12) If a marijuana item is placed in a package that is being re-used, the old label or labels must be
removed and it must have a new label or labels.
(13) A licensee or registrant must have documentation that demonstrates the validity of  the
calculation of the amount of sodium, sugar, carbohydrates and total fat in a cannabinoid edible
and must make that documentation available to the Commission or the Authority upon request.
(14) Exit packaging must contain a label that reads: “Keep out of the reach of children.”Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0100
Pre-Approval of Labels
(1) A registrant must submit labels for pre-approval in accordance with OAR 845-025-7060 and
must keep all records related to  the pre-approval process and provide those records at the
request of the Authority.
(2) On and after October 1, 2016, a registrant may not transfer a marijuana item unless the label
has been pre-approved in accordance with OAR 845-025-7060.
Stat. Auth.: ORS 475B.605Stats. Implemented: ORS 475B.605Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0200Definitions, Purpose, Scope, Effective Date
(1) In accordance with ORS 475B.625, the Authority must establish, for marijuana items sold or
transferred  to  a  consumer,  patient  or  designated  primary  caregiver  through a  Commissionlicensed marijuana retailer or medical marijuana dispensary:
(a) The maximum concentration of THC permitted in a single serving of a cannabinoid product or
cannabinoid concentrate or extract; and
(b)  The  number  of  servings  permitted  in  a  cannabinoid  product  container  or  cannabinoid
concentrate or extract container.
(2) The concentration of THC permitted under OAR 333-007-0210 through 333-007-0220 must
take into  account  both the amount  of  Delta-9 THC  in the cannabinoid product  or cannabinoidconcentrate or extract and the amount of tetrahydrocannabinolic acid (THCA) in the cannabinoidproduct or cannabinoid concentrate or extract that if  heated would convert THCA to  THC. AOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
20 of 100 8/11/2016 2:13 P Mcannabinoid product or cannabinoid concentrate or extract that contains a high amount of THCA
must meet the concentration limits established in OAR 333-007-0200 through 333-007-0220 evenif heated.
(3) The amounts of THC listed on a label are based on an average from samples taken from a
harvest or process lot and may not represent the exact amount of  THC in a marijuana itempurchased by a consumer, patient or designated primary caregiver.
(4) On and after October 1, 2016:
(a) A marijuana item received or transferred by a dispensary must meet the concentration and
serving size limits in OAR 333-007-0210 or 333-007-0220, depending on whether the marijuana isavailable for sale or transfer to a consumer, patient or designated primary caregiver; and
(b)  A  dispensary  may  not  receive  or  transfer  a  marijuana  item  that  does  not  meet  the
concentration and serving size limits in OAR 333-007-0210 or 333-007-0220, as applicable.
(5) By October 1, 2016, a dispensary must have either transferred marijuana items that do not
meet the concentration and serving size limits in OAR 333-007-0210 or 333-007-0220 to a patient
or caregiver or must have returned any marijuana item that does not meet the requirements to the
individual who  transferred the item to  the dispensary, and must document who  the item wasreturned to, what was returned and the amount, and the date of the return.
(6) For purposes of OAR 333-007-0200 through 333-007-0220:(a) The definitions in OAR 333-007-0020 apply unless otherwise specified.(b) “Cannabinoid capsule” means a small soluble container, usually made of gelatin, that encloses
a dose of a cannabinoid product, concentrate or extract intended for human ingestion.
(c) “Cannabinoid edible” means a food or potable liquid into which a cannabinoid concentrate or
extract or the dried leaves or flowers of marijuana have been incorporated.
(d)  “Cannabinoid  suppository”  means  a  small  soluble  container  designed  to  melt  at  body
temperature within a body cavity other than the mouth, especially the rectum or vagina containinga cannabinoid product, concentrate or extract.
(e) “Cannabinoid transdermal patch” means an adhesive substance applied to human skin that
contains a cannabinoid product, concentrate or extract for absorption into the bloodstream.
(f) “Medical marijuana item” is a marijuana item for sale or transfer to a patient or designated
primary caregiver and includes medical grade cannabinoid products, cannabinoid concentratesand cannabinoid extracts.
(g) “Retail adult use marijuana item” is a marijuana item for sale to a consumer.(h) “Scored” means to physically demark a cannabinoid edible in a way that enables a reasonable
person to:
(A) Intuitively determine how much of the product constitutes a single serving; and
(B) Easily physically separate the edible into single servings either by hand or with a common
utensil, such as a knife.
Stat. Auth.: ORS 475B.625Stats. Implemented: ORS 475B.625Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0210
Retail Marijuana Item Concentration and Serving Size Limits
(1) The maximum concentration or amount of THC permitted in a container and the maximum
concentration or amount of THC permitted in a serving of a retail adult use marijuana item is listed
in Table 1. [Table not included. See ED. NOTE.]
(2) A cannabinoid edible must be scored unless it is not capable of being scored because it is not
solid at room temperature in which case the cannabinoid edible must be:
(a) Sold and packaged with a measuring device that measures single servings; or(b) Placed in packaging that clearly enables a consumer to determine when a single serving has
been consumed.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
21 of 100 8/11/2016 2:13 P M(3) Serving size is as determined by the processor.
(4) A  retail adult use marijuana item that does not fall within a category in Table 1 such as
cannabinoid suppositories and transdermal patches must meet the concentration and serving sizelimits applicable to a cannabinoid edible in Table 1.
[ED. NOTE: Tables referenced are available from the agency.]Stat. Auth.: Sec. 105, ch. 614, OL 2015
Stats. Implemented: Sec. 105, ch. 614, OL 2015
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0220
Medical Marijuana Item Concentration Limits
(1) The maximum concentration or amount of THC permitted in a container and the maximum
concentration or amount of THC permitted in a serving of a medical marijuana item is listed inTable 2. [Table not included. See ED. NOTE.]
(2) A cannabinoid edible must be scored unless it is not capable of being scored because of its
form or because it is not solid at room temperature in which case the cannabinoid edible must be:
(a) Sold and packaged with a measuring device that measures single servings; or
(b) Placed in packaging that clearly enables a patient to determine when a single serving has been
consumed, as that serving size is determined by the processor.
(3) Serving size is as determined by the processor.(4) A  medical marijuana item that does not fall within a category in Table 2 must meet the
concentration and serving size limits applicable to a cannabinoid edible in Table 2.
[ED. NOTE: Tables referenced are available from the agency.]
Stat. Auth.: Sec 105, ch 614, OL 2015
Stats. Implemented: Sec 105, ch 614, OL 2015Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0300
Purpose and Effective Date
(1) The purpose of these rules is to establish the minimum testing standards for marijuana items.
These rules are applicable to:
(a) A licensee; and(b) A registrant who is not exempt from the testing requirements.
(2) The testing requirements do not apply to:
(a) A grower if the person is transferring usable marijuana or an immature marijuana plant to:(A) A patient who designated the grower to grow marijuana for the patient; or(B) A designated primary caregiver of the patient who designated the grower to grow marijuana
for the patient; or
(b) A designated primary caregiver of a patient if the caregiver is transferring a marijuana item to
a patient of the designated primary caregiver.
(3) A person registered with the Authority under ORS 475B.400 to 475B.525 who is subject to
these rules may not:
(a) Transfer a marijuana item on or after October 1, 2016, that is not sampled and tested in
accordance with these rules; or
(b) Accept the transfer of a marijuana item on or after October 1, 2016, that is not sampled and
tested in accordance with these rules.
(4) A person licensed by the Commission must comply with these rules at all times.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
22 of 100 8/11/2016 2:13 P M(5) Notwithstanding section (3)(a) of this rule, until January 1, 2017, a dispensary may transfer a
marijuana item to a patient or caregiver that was transferred to the dispensary before October 1,2016, and that was not sampled and tested in accordance with these rules if the item contains alabel placed on the package where it can easily be seen by the patient or caregiver that reads“DOES NOT MEET NEW TESTING REQUIREMENTS” in 12 point font, and in bold, capitalletters.
(6) Nothing in these rules prevents a registrant from having marijuana items sampled and tested in
accordance with these rules by an accredited and licensed laboratory prior to October 1, 2016.
(7) Prior to  October 1, 2016, an accredited laboratory performing sampling or testing for a
registrant may comply with this rule or OAR 333-008-1190 but the laboratory must identify on thetest result which rule the results are compliant with.
Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0310Definitions
For purposes of OAR 333-007-0300 through 333-007-0490:
(1) “Authority” means the Oregon Health Authority.(2) “Batch” means:(a) A quantity of usable marijuana from a harvest lot; or(b) A quantity of cannabinoid concentrate or extract or cannabinoid product from a process lot.(3)  “Cannabinoid”  means  any  of  the  chemical compounds  that  are  the  active  constituents  of
marijuana.
(4) “Cannabinoid concentrate or extract” means a substance obtained by separating cannabinoids
from marijuana by a mechanical, chemical or other process.
(5) “Cannabinoid edible” means food or potable liquid into which a cannabinoid concentrate or
extract or the dried leaves or flowers of marijuana have been incorporated.
(6)(a) “Cannabinoid product” means a cannabinoid edible or any other product intended for human
consumption or use, including a product intended to  be applied to  a person’s skin or hair, thatcontains cannabinoids or the dried leaves or flowers of marijuana.
(b) “Cannabinoid product” does not include:
(A) Usable marijuana by itself;(B) A cannabinoid concentrate or extract by itself; or(C) Industrial hemp, as defined in ORS 571.300.(7) “Cannabinoid capsule”:(a)  Means  a  small  soluble  container,  usually  made  of  gelatin that  encloses  a  dose  of  a
cannabinoid product, concentrate or extract intended for human ingestion.
(b) Does not mean a cannabinoid suppository.(8)  “Cannabinoid  suppository”  means  a  small  soluble  container  designed  to  melt  at  body
temperature within a body cavity other than the mouth, especially the rectum or vagina containinga cannabinoid product, concentrate or extract.
(9) “Cannabinoid tincture” means a solution of  alcohol, cannabinoid concentrate or extract, and
perhaps other ingredients intended for human consumption or ingestion, and that is exempt from
the Liquor Control Act under ORS 471.035.
(10) “Cannabinoid topical” means a cannabinoid product intended to be applied to skin or hair and
for purposes of testing includes transdermal patches.
(11) Cannabinoid Transdermal patch” means an adhesive substance applied to human skin that
contains a cannabinoid product, concentrate or extract for absorption into the bloodstream.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
23 of 100 8/11/2016 2:13 P M(12) “CBD” means cannabidiol, Chemical Abstracts Service Number 13956-29-1.
(13) “CBDA” means cannabidiolic acid, Chemical Abstracts Service Number 1244-58-2.(14) “Chain of custody procedures” means procedures employed by laboratory personnel using a
chain of custody form to record the possession of samples from the time of sampling through theretention time specified by the Authority or Commission.
(15) “Chain of custody form” means a form completed by laboratory personnel that documents
the collection, transport, and receipt of samples by the laboratory.
(16) “Commission” means the Oregon Liquor Control Commission.
(17) “Consumer” has the meaning given that term in ORS 475B.015 and does not include a patient
or designated primary caregiver.
(18)  “Delta-9  THC”  is  the  principal  psychoactive  constituent  (the  principal  cannabinoid)  of
cannabis, Chemical Abstracts Service Number 1972-08-3.
(19)(a) “Designated primary caregiver” means an individual 18 years of age or older who has
significant responsibility for managing the well-being of a person who has been diagnosed with a
debilitating medical condition,  who  is  designated as  such on that  person’s  application for a
registry identification card or in other written notification to the Authority, and who has been issuedan identification card by the Authority under ORS 475B.415(5)(b).
(b) “Designated primary caregiver” does not include the person’s attending physician.(20)  “Field  duplicate  sample”  means  a  sample  taken  in  an  identical  manner  from  and
representative of the same marijuana item being sampled that is analyzed separately, that is usedfor quality control only.
(21) “Food” means a raw, cooked, or processed edible substance, or ingredient used or intended
for use or for sale in whole or in part for human consumption, or chewing gum.
(22) “Grower” has the same meaning as “person responsible for a marijuana grow site.”(23) “Grow site” means a specific location registered by the Authority and used by the grower to
produce marijuana for medical use by a specific patient under ORS 475B.420.
(24) “Harvest lot “ means a specifically identified quantity of marijuana that is uniform in strain,
cultivated utilizing the same growing practices, harvested at the same time at the same location
and cured under uniform conditions.
(25)  “Homogeneous”  means  a  cannabinoid  product,  concentrate  or  extract  has  uniform
composition and properties throughout each process lot.
(26)  “Human consumption or  human ingestion”  means  to  ingest,  generally  through the  mouth,
food, drink or other substances such that the substance enters the human body but does notinclude inhalation.
(27) “Laboratory” means a laboratory that is accredited under ORS 438.605 to 438.620 to sample
or conduct tests on marijuana items and licensed by the Oregon Liquor Control Commission
under ORS 475B.560.
(28) “Licensee” has the meaning given that term in ORS 475B.015.(29)(a) “Marijuana” means the plant Cannabis family Cannabaceae, any part of the plant Cannabis
family Cannabaceae and the seeds of the plant Cannabis family Cannabaceae.
(b) “Marijuana” does not include industrial hemp, as defined in ORS 571.300.(30) “Marijuana item” means marijuana, usable marijuana, a cannabinoid product or a cannabinoid
concentrate or extract.
(31)  “Marijuana  processing  site”  means  a  marijuana  processing  site  registered  under  ORS
475B.435.
(32)  “Medical marijuana  dispensary”  or  “dispensary”  means  a  medical marijuana  dispensary
registered under ORS 475B.450.
(33)  “ORELAP”  means  the  Oregon  Environmental  Laboratory  Accreditation  Program
administered by the Authority pursuant to ORS 438.605 to 438.620.
(34) “Patient” has the same meaning as “registry identification cardholder.”
(35) “Person responsible for a marijuana grow site” has the same meaning as “grower” and means
a person who has been selected by a patient to produce medical marijuana for the patient andOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
24 of 100 8/11/2016 2:13 P Mwho has been registered by the Authority for this purpose under ORS 475B.420.
(36) “Process lot” means:(a) Any amount of cannabinoid concentrate or extract of the same type and processed using the
same extraction methods,  standard  operating  procedures  and  batches  from  the  same  or adifferent harvest lot; or
(b) Any amount of  a cannabinoid product of  the same type and processed using the same
ingredients, standard operating procedures and batches from the same or a different harvest lot
or process lot of cannabinoid concentrate or extract as defined in subsection (a) of this section.
(37)  “Process  validation”  means  a  study  performed  on  products  or  matrices  of  unknown
homogeneity to assure required uniformity of product accomplished through a series of samplingand testing from three consecutive process lots as described in OAR 333-007-0440.
(38) “Processing” means the compounding or conversion of marijuana into cannabinoid products
or cannabinoid concentrates or extracts.
(39) “Processing site” means a processor registered with Authority under ORS 475B.435.
(40) “Processor” has the meaning given that term in OAR 845-025-1015.
(41) “Producer” has the meaning given that term in OAR 845-025-1015.(42) “Producing” means:(a) Planting, cultivating, growing, trimming or harvesting marijuana; or(b) Drying marijuana leaves and flowers.(43) “Registrant” means a grower, marijuana processing site, or a medical marijuana dispensary
registered with the Authority under ORS 475B.420, 475B.435 or 475B.450.
(44) “Registry identification cardholder” means a person who has been diagnosed by an attending
physician with a debilitating medical condition and for whom the use of medical marijuana maymitigate the symptoms or effects of the person’s debilitating medical condition, and who has beenissued a registry identification card by the Authority under ORS 475B.415(5)(a).
(45) “Relative percentage difference” or “RPD” means the comparison of two quantities while
taking into account the size of what is being compared as calculated under OAR 333-064-0100..
(46)  “Relative  standard  deviation”  or  “RSD”  means  the  standard  deviation expressed  as  a
percentage of the mean recovery as calculated under OAR 333-064-0100.
(47) “Sample” means an amount of a marijuana item collected by laboratory personnel from a
registrant or licensee and provided to a laboratory for testing.
(48)  “Sterilization”  means  the  removal  of  all  microorganisms  and  other  pathogens  from  a
marijuana item by treating it with approved chemicals or subjecting it to high heat.
(49) “Test batch” means a group of samples from a batch submitted collectively to a laboratory
for testing purposes.
(50) “THC” means tetrahydrocannabinol and has the same Chemical Abstracts Service Number
as delta-9 THC.
(51)  “THCA”  means  tetrahydrocannabinolic  acid,  Chemical  Abstracts  Service  Number
23978-85-0.
(52) “These rules” means OAR 333-007-0300 through 333-007-0490.(53) “TNI” means The NELAC (National Environmental Laboratory Accreditation Conference)
Institute, a voluntary organization of state and federal environmental officials and interest groups
purposed primarily to establish consensus standards for accrediting environmental laboratories.
(54) “TNI EL Standards” means the adopted 2009 TNI Environmental Lab Standards (© 2009 The
NELAC  Institute),  which  describe  the  elements  of  laboratory  accreditation  developed  andestablished by the consensus principles of TNI and that meet the approval requirements of TNIprocedures and policies.
(55) “Total THC” means the molar sum of THC and THCA.(56)(a) “Usable marijuana” means the dried leaves and flowers of marijuana.
(b) “Usable marijuana” does not include:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
25 of 100 8/11/2016 2:13 P M(A) The seeds, stalks and roots of marijuana; or
(B) Waste material that is a by-product of producing or processing marijuana.Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0315
Ordering Tests
A registrant or licensee must provide a laboratory, prior to laboratory taking samples, with the
following:
(1) A written request of analysis for each test the laboratory is being requested to conduct.(2) Notification of whether the batch is being re-sampled because of a failed test and the failed
test results.
(3) Certification of  successful process validation, if  applicable, on a form prescribed by the
Authority.
(4) Proof of a waiver under OAR 333-007-0490, if applicable.
Stat. Auth.: ORS 475B.555
Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0320
Testing Requirements for Marijuana or Usable Marijuana
(1) A producer or grower must test every harvest lot of marijuana or usable marijuana intended for
use by a consumer or patient prior to selling or transferring the marijuana or usable marijuana forthe following:
(a) Pesticides in accordance with OAR 333-007-0400.
(b) Water activity and moisture content in accordance with OAR 333-007-0420.
(c) THC and CBD concentration in accordance with OAR 333-007-0430.(2) A producer or grower must test every harvest lot of marijuana or usable marijuana intended for
use by a processor or processing site for water activity and moisture content in accordance withOAR 333-007-0420 unless the processor or processing site uses a method of processing thatresults in effective sterilization.
( 3 ) A p r o d u c e r o r g r o w e r m u s t t e s t a h a r v e s t l o t o f m a r i j u a n a o r u s a b l e m a r i j u a n a f o r
microbiological contaminants in accordance with OAR 333-007-0390, upon written request by the
Authority or the Commission.
(4) In lieu of ordering and arranging for the sampling and testing required in this rule a producer
may  transport  batches  of  marijuana  or  usable  marijuana  to  a  wholesaler  licensed  by  theCommission under ORS 475B.100 and the wholesaler may order and arrange for the samplingand testing of the batches, in accordance with rules established by the Commission.
Stat. Auth.: ORS 475B.555
Stats. Implemented: ORS 475B.555
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0330
Testing Requirements for Cannabinoid Concentrates and Extracts
(1) A processor or processing site must test every process lot of cannabinoid concentrate or
extract  for  use  by  a  consumer  or  patient  prior  to  selling  or  transferring  the  cannabinoidconcentrate or extract for the following:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
26 of 100 8/11/2016 2:13 P M(a) Pesticides in accordance with OAR 333-007-0400.
(b) Solvents in accordance with OAR 333-007-0410.(c) THC and CBD concentration in accordance with OAR 333-007-0430.(2) A processor or processing site must test every process lot of a cannabinoid concentrate or
extract intended for use by a processor or processing site to make a cannabinoid product for thefollowing:
(a) Pesticides in accordance with OAR 333-007-0400.
(b) Solvents in accordance with OAR 333-007-0410.(3) A processor or processing site is exempt from testing for solvents under this rule if  the
processor or processing site:
(a) Did not use any solvent listed in OAR 333-007-0410, Table 4; and(b) Only used a mechanical extraction process to separate cannabinoids from the marijuana; or(c) Used only water, animal fat or vegetable oil as a solvent to separate the cannabinoids from the
marijuana.
(4) A processor or processing site must test a process lot of a cannabinoid concentrate or extract
for microbiological contaminants in accordance with OAR 333-007-0390, upon written request bythe Authority or the Commission.
(5) In lieu of ordering and arranging for the sampling and testing required in this rule a processor
may transport batches of cannabinoid concentrates or extracts to a wholesaler licensed by theCommission under ORS 475B.100 and the wholesaler may order and arrange for the sampling
and testing of the batches, in accordance with rules established by the Commission.
Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0340
Testing  Requirements  for  Cannabinoid  Products  Intended  for  Human  Consumption  or
Ingestion and Cannabinoid Suppositories
(1) A processor or processing site must test every process lot of a cannabinoid product intended
for human consumption or ingestion, including cannabinoid edibles, capsules, and tinctures, andcannabinoid suppositories for use by  a consumer or patient prior to  selling or transferring thecannabinoid product for THC and CBD concentration in accordance with OAR 333-007-0430.
(2) A processor or processing site must test a process lot for microbiological contaminants in
accordance with OAR 333-007-0390, upon written request by the Authority or the Commission.
(3) In lieu of ordering and arranging for the sampling and testing required in this rule a processor
may  transport  batches  of  cannabinoid  products  references  in  section  (1)  of  this  rule  to  a
wholesaler licensed by the Commission under ORS 475B.100 and the wholesaler may order and
arrange for the sampling and testing of the batches, in accordance with rules established by theCommission.
Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0345
Testing Requirements for Cannabinoid Topicals and Cannabinoid Transdermal Patches
(1) A  processor or processing site must test every process lot of  a cannabinoid topical or
transdermal patch for use by a consumer or patient prior to selling or transferring the cannabinoid
product for THC and CBD concentration in accordance with OAR 333-007-0430.
(2) A processor or processing site must test a process lot of a cannabinoid topical or transdermal
patch for microbiological contaminants  in accordance with OAR  333-007-0390,  upon writtenrequest by the Authority or the Commission.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
27 of 100 8/11/2016 2:13 P M(3) In lieu of ordering and arranging for the sampling and testing required in this rule a processor
may  transport  batches  of  cannabinoid  products  references  in  section  (1)  of  this  rule  to  awholesaler licensed by the Commission under ORS 475B.100 and the wholesaler may order andarrange for the sampling and testing of the batches, in accordance with rules established by theCommission.
Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555
Hist.: PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-007-0350Batch Size
(1) Usable marijuana.
(a) A producer or grower must separate each harvest lot into no larger than 10 pound batches.(b) Notwithstanding subsection (1)(a) of this rule, a producer or grower may combine harvest lots
together for purposes of having a batch sampled if each batch is intended for use by a processoror processing site to make a cannabinoid concentrate or extract and each harvest lot was:
(A) Cultivated utilizing the same growing practices and grown in close proximity on the licensed or
registered premises;
(B) Harvested at the same time; and
(C) If cured prior to sampling, cured under uniform conditions.(c) A producer or grower may not combine harvest lots into a batch for purposes of sampling and
testing for THC or CBD.
(d) If harvest lots are combined in accordance with subsection (1)(b) of this rule the batch must be
labeled so that it identifies the different harvest lots that were combined.
(2) Cannabinoid concentrates and extracts and cannabinoid products. A process lot is considered
a batch.
(3) A grower and processing site must assign each batch a unique batch number and that unique
batch number must be:
(a) Documented and maintained in the grower and processing site records for at least two years
and available to the Authority upon request;
(b) Provided to the individual responsible for taking samples; and
(c) Included on the batch label as required in OAR 333-007-0380.
(4) A grower and processing site may not reuse a unique batch number.Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0360
Sampling and Sample Size
(1) Usable marijuana.(a) Usable marijuana may  only  be sampled after it is  cured, unless the usable marijuana is
intended for sale or transfer to a processor or processing site to make a cannabinoid concentrate
or extract.
(b) Samples taken must in total represent a minimum of 0.5 percent of the batch, consistent with
the  laboratory’s  accredited  sampling  policies  and  procedures,  described  in  OAR333-064-0100(2).
(2) Cannabinoid concentrates, extracts and products.(a)  Unless  a  cannabinoid  concentrate,  extract  or  product  has  successfully  passed  process
validation, enough samples from a batch must be taken to ensure that the required attributes in theOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
28 of 100 8/11/2016 2:13 P Mbatch to  be tested are homogenous and consistent with the laboratory’s accredited sampling
policies and procedures described in OR 333-064-0100(2).
(b) If a cannabinoid concentrate, extract or product has successfully passed process validation
only a primary sample and field duplicate sample must be taken from a batch in accordance withthe laboratory’s accredited sampling policies and procedures described in OAR 333-064-0100(2).
Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0370
Sampling Personnel Requirements; Sampling Recordkeeping
(1) Only  individuals  employed  by  a  laboratory  with an ORELAP  accredited  scope  item  for
sampling under these rules may take samples.
(2) Sampling may  be conducted at  a  licensee’s  or registrant’s  premises  or the  licensee or
registrant may transport the batch to a laboratory with an ORELAP accredited scope item forsampling under these rules.
(3) Laboratory personnel that perform sampling must:
(a) Follow the laboratory’s accredited sampling policies and procedures;
(b) Follow chain of custody procedures consistent with TNI EL Standard V1M2 5.7 and 5.8; and(c) After taking samples document the samples in accordance with OAR 333-064-0100(2) and if
sampling for a licensee record the sampling and transfer information in the Commission’s seed tosale system, as required by the Commission.
(4) A laboratory must maintain the documentation required in these rules for at least two years
and must provide that information to the Authority upon request.
Stat. Auth.: ORS 475B.555
Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0380
Grower and Processing Site Requirements for Labeling, Storing, and Securing Pre-Tested
Marijuana Items; Recordkeeping
(1) Following samples being taken from a harvest or process lot batch a grower or processing site
must:
(a) Label the batch with the following information:(A) The registrant’s registration number;(B) The harvest or process lot unique identification number;(C) The name and accreditation number of the laboratory that took samples and the name and
accreditation number of the laboratory responsible for the testing, if different;
(D) The test batch or sample unique identification numbers supplied by the laboratory personnel;
(E) The date the samples were taken; and(F) In bold, capital letters, no smaller than 12 point font, “PRODUCT NOT TESTED.”(b) Store and secure the batch in a manner that prevents the product from being tampered with or
transferred prior to test results being reported.
(c) Be able to easily locate a batch stored and secured under section (1)(b) of  this rule and
provide that location to the Authority or a laboratory upon request.
(2) If the samples pass testing the product may be sold or transferred in accordance with the
applicable Authority rules.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
29 of 100 8/11/2016 2:13 P M(3) If  the samples do not pass testing the grower or processing site must comply with OAR
333-007-0450.
Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0390
Standards for Testing Microbiological Contaminants
(1) A marijuana item required to be tested for microbiological contaminants must be sampled
using appropriate aseptic technique and tested by a laboratory for total coliform count.
(2) If  a laboratory detects the presence of  any coliforms the sample must be assessed for
Escherichia coli (E. coli).
(3) A batch fails microbiological contaminant testing if the laboratory detects the presence of E.
coli at more than 100 colony forming units per gram in a sample:
(a) During an initial test where no reanalysis is requested; or(b) Upon reanalysis as described in OAR 333-007-0450(1).
Stat. Auth.: ORS 475B.555
Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0400
Standards for Testing Pesticides
(1) A marijuana item required to be tested for pesticides must be tested by a laboratory for the
analytes listed in Exhibit A, Table 3, incorporated by reference. [Table not included. See ED.NOTE.]
(2) A batch fails pesticide testing if a laboratory detects the presence of a pesticide above the
action levels listed in Exhibit A, Table 3 in a sample:
(a) During an initial test where no reanalysis is requested; or(b) Upon reanalysis as described in OAR 333-007-0450(1). [Table not included. See ED. NOTE.](3) The Authority will review and update, if necessary, the analytes listed in Exhibit A, Table 3, at
least every two years.
[ED. NOTE: Tables referenced are available from the agency.]Stat. Auth.: ORS 475B.555
Stats. Implemented: ORS 475B.555
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0410
Standards for Testing Solvents
(1) A marijuana item required to be tested for solvents must be tested by a laboratory for the
analytes listed in Exhibit A, Table 4 incorporated by reference. [Table not included. See ED.NOTE.]
(2) A  batch fails  solvent  testing if  a laboratory, during an initial test  where no  reanalysis  is
requested or upon reanalysis as described in OAR 333-007-0450(1):
(a) Detects the presence of a solvent above the action level listed in Exhibit A, Table 4 in a
sample; or [Table not included. See ED. NOTE.]
(b) Calculates a RPD of more than 20 percent between the field primary result of the sample and
the field duplicate result.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
30 of 100 8/11/2016 2:13 P M(3) The Authority will review and update, if necessary, the analytes listed in Exhibit A, Table 4, at
least every two years. [Table not included. See ED. NOTE.]
[ED. NOTE: Tables referenced are available from the agency.]Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0420Standards for Testing Water Activity and Moisture Content
(1) Usable marijuana must be tested by a laboratory for:
(a) Water activity; and(b) Moisture content.(2) If a sample has a water activity rate of more than 0.65 Aw the sample fails.(3) If a sample has a moisture content of more than 15 percent the result must be reported to the
licensee but the sample does not fail.
Stat. Auth.: ORS 475B.555
Stats. Implemented: ORS 475B.555
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0430
Standards for THC and CBD Testing
(1) A laboratory must test for the following when testing a marijuana item for potency:(a) THC.(b) THCA.(c) CBD.
(d) CBDA.
(2) A  process lot of  a cannabinoid concentrate, extract or product that has not successfully
completed process validation fails potency testing if, based on an initial test where no reanalysisis requested or upon reanalysis as described in OAR 333-007-0450(1):
(a) The amount of THC, as calculated pursuant to OAR 333-064-0100, between samples taken
from the batch exceeds 30 percent RSD; or
(b) The amount or percentage of THC, as calculated pursuant to OAR 333-064-0100, exceeds the
maximum  concentration limits  permitted  in package  as  specified  in OAR  333-007-0200  to
333-007-0220, as applicable.
(3) A process lot of a cannabinoid concentrate, extract or product that has successfully completed
process validation fails potency testing if, based on an initial test where no reanalysis is requestedor upon reanalysis as described in OAR 333-007-0450(1):
(a) The amount of THC, as calculated pursuant to OAR 333-064-0100, between the sample and
the field duplicate exceeds 20 percent RPD; or
(b) The amount or percentage of THC, as calculated pursuant to OAR 333-064-0100, exceeds the
maximum concentration limits permitted in a package as specified in OAR 333-007-0200 to333-007-0220, as applicable.
(4) A sample cannot fail CBD testing.(5) Notwithstanding section (2)(a) and (3)(a) of this rule, a sample that has less than 5 mg of THC
as calculated pursuant to OAR 333-064-0100 does not fail potency testing based on exceedanceof the RSD or RPD as described in section (2)(a) or (3)(a) of this rule.
Stat. Auth.: ORS 475B.555Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
31 of 100 8/11/2016 2:13 P MStats. Implemented: ORS 475B.555
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0440
Process Validation
(1) A  laboratory may perform process validation tests on three consecutive process lots of
cannabinoid  concentrates,  extracts  or  products  for  a  processor  or  processing  site  if  theprocessor or processing site informs the laboratory, in writing:
(a) That sampling and testing is for the purposes of process validation; and(b) For cannabinoid products, the expected THC range for the product.
(2) Samples taken for purposes of process validation testing may not be combined.
(3) Samples of cannabinoid concentrate and extracts must be tested for:(a) Pesticides in accordance with OAR 333-007-0400,(b) Solvents in accordance with OAR 333-007-0410.(4) Samples of cannabinoid products must be tested for THC concentration in accordance with
OAR 333-007-0430, as calculated pursuant to OAR 333-064-0100.
(5) During process validation a batch passes:
(a) Pesticide testing if each sample is below the action limit established in OAR 333-007-0400.(b) Solvent testing if:(A) Each sample is below the action limit established in OAR 333-007-0410; and(B) The results above the LOQ are not greater than 30 percent RSD between samples.(c) THC concentration testing if:
(A) The amount of THC, as calculated pursuant to OAR 333-064-0100, between samples taken
from the batch does not exceed 30 percent RSD; and
(B) The amount or percentage of THC as calculated pursuant to OAR 333-064-0100, does not
exceed  the  maximum  concentration  limit  permitted  in  a  package  as  specified  in  OAR333-007-0200 to 333-007-0220, as applicable.
(6) A laboratory must identify on a form prescribed by the Authority if a batch undergoing process
validation has passed for any of the following:
(a) Pesticides, if applicable.
(b) Solvents, if applicable.(c) THC concentration as calculated pursuant to OAR 333-064-0100, if applicable.(7)  A  process  lot  sampled  and  tested  for  purposes  of  process  validation may  be  sold  or
transferred if the samples pass all the required tests.
(8) A processor or processing site must undergo process validation for a product again or must
have batches sampled and tested as if the product had not undergone process validation if:
(a) There are any changes to the standard operating procedures for that product.
(b) There are any changes in the type of ingredient in the product, except for a difference in the
strain of usable marijuana, or the purity of an ingredient.
(9) Process validation is only valid for two years.Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0450Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
32 of 100 8/11/2016 2:13 P MFailed Test Samples
(1) If a sample fails any initial test the laboratory that did the testing may reanalyze the sample. If
the sample passes, another laboratory must resample the batch and confirm that result in orderfor the batch to pass testing.
(2) If a sample fails a test or a reanalysis under section (1) of this rule the batch:
(a) May be remediated or sterilized in accordance with this rule; or
(b) If it is not or cannot be remediated or sterilized under this rule, must be destroyed in a manner
specified by the Authority or the Commission.
(3) If a licensee or registrant is permitted under this rule to sell or transfer a batch that has failed a
test, the licensee or registrant must notify the licensee or registrant to whom the batch is sold ortransferred of the failed test.
(4) Failed microbiological contaminant testing.
(a) If a sample from a batch of usable marijuana fails microbiological contaminant testing the
batch may be used to  make a cannabinoid concentrate or extract if  the processing methodeffectively sterilizes the batch, such as a method using a hydrocarbon based solvent or a CO2closed loop system.
(b)  If  a  sample  from  a  batch of  a  cannabinoid  concentrate  or  extract  fails  microbiological
contaminant testing the batch may be further processed if  the processing method effectivelysterilizes the batch, such as a method using a hydrocarbon based solvent or a CO2 closed loop
system.
(c) A batch that is sterilized in accordance with subsection (a) or (b) of this section must be
sampled and tested in accordance with these rules and must be tested if not otherwise requiredfor that product, for microbiological contaminants, solvents and pesticides.
(d) A batch that fails microbiological contaminant testing after undergoing a sterilization process in
accordance with subsection (a) or (b) of this section must be destroyed in a manner specified bythe Authority or the Commission.
(5) Failed solvent testing.
(a) If a sample from a batch fails solvent testing the batch may be remediated using procedures
that would reduce the concentration of solvents to less than the action level.
(b) A batch that is remediated in accordance with subsection (a) of this section must be sampled
and tested in accordance with these rules and must be tested if not otherwise required for thatproduct under these rules, for solvents and pesticides.
(c) A batch that fails solvent testing that is not remediated or that if remediated fails testing must
be destroyed in a manner specified by the Authority or the Commission.
(6) Failed water activity testing.(a) If a sample from a batch of usable marijuana fails for water activity the batch from which the
sample was taken may:
(A) Be used to make a cannabinoid concentrate or extract; or(B) Continue to dry or cure.(b) A batch that undergoes additional drying or curing as described in paragraph (a)(B) of this
section must be sampled and tested in accordance with these rules.
(7) Failed pesticide testing.(a) If a sample from a batch fails pesticide testing the batch may not be remediated and must be
destroyed in a manner approved by the Authority or the Commission.
(b) The Authority must report to the Oregon Department of Agriculture all test results that show
that a sample failed a pesticide test.
(8) Failed potency testing.
(a) A marijuana item that fails potency testing under OAR 333-007-0430(2)(a) or (3)(a) may be
repackaged in a manner that enables the item to meet the standard in OAR 333-007-0430(2)(a) or(3)(a).
(b) A marijuana item that is repackaged in accordance with this section must be sampled and
tested in accordance with these rules.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
33 of 100 8/11/2016 2:13 P M(9) If a sample fails a test after undergoing remediation or sterilization as permitted under this rule
the batch must be destroyed in a manner approved by the Authority or the Commission.
(10) An Authority representative must witness the destruction of a batch if destruction is required
by this rule.
(11) A registrant must inform a laboratory prior to samples being taken that the batch has failed a
test and is being retested after undergoing remediation or sterilization.
(12) A registrant must, as applicable:
(a) Have detailed procedures for sterilization processes to remove microbiological contaminants
and for reducing the concentration of solvents.
(b) Document all sampling, testing, sterilization, remediation and destruction that are a result of
failing a test under these rules.
Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0470
Tentative Identification of Compounds
(1) Tentatively Identified Compounds (TICs) are compounds detected in a sample using gas
chromatography  mass  spectrometry  that  are not  among the target  analytes  for the residualsolvent analysis.
(2) The Authority may initiate an investigation of a registrant upon receipt of a TICS report from a
laboratory and may require a registrant to submit samples for additional testing, including testingfor analytes that are not required by these rules, at the registrant’s expense.
Stat. Auth.: ORS 475B.555
Stats. Implemented: ORS 475B.555
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0480
Audit and Random Testing
(1) The Authority may require a registrant to  submit samples identified by the Authority to  a
laboratory of the registrant’s choosing to be tested in order to determine whether a registrant is incompliance with OAR 333-007-0300 through 333-007-0490, and may require additional testingthat is not required by these rules.
(2) A laboratory doing audit testing must comply with these rules, to the extent they are applicable,
and if conducting testing not required by these rules, may only use Authority approved methods.
(3)  The  Authority  must  establish a  process  for  the  random  testing  of  marijuana  items  for
microbiological contaminants that ensures each registrant tests every product for microbiologicalcontaminants at least once a year.
Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555
Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-007-0490
Waiver of Sampling and Testing Requirements
(1) Solvent testing.(a) The Commission or the Authority may, upon receipt of a written request from a licensee or
registrant, waive a requirement that every batch of a process lot be tested for solvents, if thelicensee or registrant can demonstrate that none of the batches from any of the previous fourprocess lots tested failed a solvent test.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
34 of 100 8/11/2016 2:13 P M(b) In order to qualify for a waiver under this section the fourth process lot must be processed at
least 30 days after the first.
(c) If the waiver is granted the Commission or Authority must provide notice, in writing, to the
registrant or licensee of the waiver and how long the waiver will be in effect.
(d) If the Commission or the Authority waives the testing requirement the licensee or registrant is
subject to  random testing and the Commission or the Authority  shall notify  the licensee orregistrant when a process lot must be tested in accordance with these rules.
(2) Sampling.
(a) The Commission or the Authority may, upon receipt of a written request from a processor or
processing site waive the sampling requirements in OAR 333-007-0360(2)(a) for a particularproduct if the processor processing site:
(A) Can demonstrate that none of the batches from any of the previous four process lots tested
failed any test;
(B)  Submits  to  the  Commission  or  the  Authority  detailed  processing  standard  operating
procedures that demonstrate the product is uniform and uniform from process lot to process lot;
(C) Can demonstrate that it has and follows quality control measures; and(D) Can demonstrate that subjecting a product to process validation under OAR 333-007-0440 is
cost prohibitive.
(b) In order to qualify for a waiver under this section the fourth process lot must be processed at
least 30 days after the first.
(c) If the waiver is granted the Commission or Authority must provide notice, in writing, to the
registrant or licensee of the waiver, how long the waiver will be in effect, and the sampling that is
required of the product for which the waiver was approved.
Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-008-0010
Definitions
For the purposes of OAR chapter 333, division 8 the following definitions apply unless otherwise
indicated:
(1) “Advertising” means publicizing the trade name of  a PRMG, registered processing site or
dispensary together with words or symbols referring to marijuana or publicizing the brand name ofmarijuana or a medical cannabinoid product, concentrate or extract in any medium.
(2) “Applicant” means, as applicable to the registration being applied for:(a) An individual applying for a registry identification card under ORS 475B.415.(b) An individual applying for a grow site registration under ORS 475B.420.
(c) A person applying for a marijuana processing site registration under ORS 475B.435.
(d) A person applying for a medical marijuana dispensary registration under ORS 475B.450.(3) “Attending physician” means a Doctor of  Medicine (MD) or Doctor of  Osteopathy (DO),
licensed under ORS chapter 677, who has primary responsibility for the care and treatment of aperson diagnosed with a debilitating medical condition.
(4) “Attending physician statement” or “APS” means the form, prescribed by the Authority and
signed by an attending physician, that states the individual has been diagnosed with a debilitating
medical condition and that the medical use of marijuana may mitigate the symptoms or effects of
the individual’s debilitating medical condition.
(5) “Authority” means the Oregon Health Authority.(6) “Business day” means Monday through Friday excluding legal holidays.(7) “CBD” means cannabidiol.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
35 of 100 8/11/2016 2:13 P M(8)  “Cannabinoid”  means  any  of  the  chemical compounds  that  are  the  active  constituents  of
marijuana.
(9) “Cannabinoid concentrate” means a substance obtained by separating cannabinoids from
marijuana by:
(a) A mechanical extraction process;(b) A chemical extraction process using a nonhydrocarbon-based solvent, such as vegetable
glycerin, vegetable oils, animal fats, isopropyl alcohol or ethanol;
(c) A chemical extraction process using the hydrocarbon-based solvent carbon dioxide, provided
that the process does not involve the use of high heat or pressure; or
(d) Any other process authorized in these rules.(10) “Cannabinoid edible” means food or potable liquid into  which a cannabinoid concentrate,
cannabinoid extract or dried leaves or flowers of marijuana have been incorporated.
(11)  “Cannabinoid  extract”  means  a  substance  obtained  by  separating  cannabinoids  from
marijuana by:
(a) A chemical extraction process using a hydrocarbon-based solvent, such as butane, hexane or
propane; or
(b) A chemical extraction process using the hydrocarbon-based solvent carbon dioxide, if  the
process uses high heat or pressure.
(12) “Cartoon” means any drawing or other depiction of an object, person, animal, creature or any
similar caricature that satisfies any of the following criteria:
(a) The use of comically exaggerated features;
(b) The attribution of human characteristics to animals, plants or other objects, or the similar use
of anthropomorphic technique; or
(c) The attribution of unnatural or extra-human abilities, such as imperviousness to pain or injury,
X-ray vision, tunneling at very high speeds or transformation.
(13) “Commission” means the Oregon Liquor Control Commission.(14) “Conviction” means an adjudication of guilt upon a verdict or finding entered in a criminal
proceeding in a court of competent jurisdiction.
(15) “Database” means the electronic system established pursuant to ORS 475B. 458, in which the
Authority  stores  the  information PRMGs,  registered  processing  sites  and  dispensaries  arerequired to submit under these rules.
(16) “Debilitating medical condition” means:(a) Cancer, glaucoma, a degenerative or pervasive neurological condition, positive status for
human immunodeficiency virus or acquired immune deficiency syndrome, or a side effect relatedto the treatment of those medical conditions;
(b) A medical condition or treatment for a medical condition that produces, for a specific patient,
one or more of the following:
(A) Cachexia;(B) Severe pain;(C) Severe nausea;(D) Seizures, including but not limited to seizures caused by epilepsy; or
(E) Persistent muscle spasms, including but not limited to spasms caused by multiple sclerosis;
(c) Post-traumatic stress disorder; or(d) Any other medical condition or side effect related to the treatment of a medical condition
adopted by the Authority by rule or approved by the Authority pursuant to a petition filed underOAR 333-008-0090.
(17) “Delivery” has the meaning given that term in ORS 475B.410.(18)(a) “Designated primary caregiver” means an individual who:
(A) Is 18 years of age or older;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
36 of 100 8/11/2016 2:13 P M(B)  Has  significant  responsibility  for  managing  the  well-being  of  a  person  who  has  been
diagnosed with a debilitating medical condition; and
(C) Is designated as the person responsible for managing the well-being of a person who has
been diagnosed with a debilitating medical condition on that person’s application for a registryidentification card or in other written notification submitted to the Authority.
(b) “Designated primary caregiver” does not include a person’s attending physician.(19) “Direct interest” means an interest that is held in the name of the individual.
(20) “Domicile” means the place an individual intends as his or her fixed place of  abode or
habitation where he or she intends to remain and to which, if absent, the individual intends toreturn.
(21) “Elementary  school”  means  a  learning  institution containing any  combination of  grades
Kindergarten through 8.
(22) “Employee”:(a) Means any individual, including an alien, employed for remuneration or under a contract of
hire, written or oral, express or implied, by an employer.
(b)  Does  not  mean  an  individual  who  volunteers  or  donates  services  performed  for  no
remuneration or without expectation or contemplation of remuneration as adequate considerationfor the services performed for a religious or charitable institution or a governmental entity.
(23)  “Food  stamps”  means  the  Supplemental Nutrition Assistance  Program  as  defined  and
governed by ORS 411.806 through 411.845.
(24) “Grandfathered grow site” means a grow site registered by the Authority that has been
approved by the Authority under OAR 333-008-0520 that can have up to:
(a) 24 mature marijuana plants if the location is within city limits and zoned residential; or(b) 96 mature marijuana plants if the location is within city limits but not zoned residential or not
within city limits.
(25) “Grow site” means a location registered under ORS 475B.420 where marijuana is produced
for use by a patient or, with permission from a patient, for transfer to a registered processing siteor dispensary.
(26) “Grow site registration card” means a card issued by the Authority that identifies the address
of a marijuana grow site and the PRMG.
(27) “Immature marijuana plant” means a marijuana plant that is not flowering.(28) “Indirect interest” means:(a) An interest that is owned by a business entity that is owned, in whole or in part and either
directly or indirectly, through one or more other intermediate business entities, by the individual; or
(b) An interest held in the name of another but the benefits of ownership of which, the individual is
entitled to receive.
(29) “Individual who  has a financial interest” in a business entity that owns a processing site or
dispensary means:
(a) If the business entity is a corporation:(A) Stock h ol ders: An y in dividu al w h o ow n s, directl y or in directl y , 10 percen t or more of th e
outstanding stock of such corporation.
(B) Directors: Any director of  the corporation who  receives compensation for acting in that
capacity or who owns, directly or indirectly, 5 percent or more of the outstanding stock of suchcorporation.
(C) Officers: Any officer of the corporation who receives compensation for acting in that capacity
or who owns, directly or indirectly, 5 percent or more of the outstanding stock of such corporation.
(b) If the business entity is a trust:(A) Trustees: Any individual who is a trustee of the trust and who receives compensation for
acting in that capacity and any individual who owns, directly or indirectly, 10 percent or more of
th e ow n ersh ip in terests of a bu sin ess en tity th at is a tru stee of th e tru st an d th at receives
compensation for acting in that capacity.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
37 of 100 8/11/2016 2:13 P M(B) Beneficiaries: Any individual who is entitled to receive, directly or indirectly, income or benefit
from the trust.
(c) If the business entity is a partnership:(A) General Partners: Any individual who is a general partner of the partnership and who receives
compensation for acting in that capacity  or who  owns  5 percent or more of  the ownershipinterests of the partnership and any individual who owns, directly or indirectly, 10 percent or moreof the ownership interests of a business entity that is a general partner of the partnership and that
receives compensation for acting in that capacity or owns 5 percent or more of the ownership
interests of the partnership.
(B) Limited Partners: Any individual who is a limited partner of the partnership and who owns 10
percent or more of  the ownership interests of  the partnership and any individual who  owns,directly or indirectly, 10 percent or more of the ownership interests of a business entity that is alimited partner of the partnership and that owns 10 percent or more the ownership interests of thepartnership.
(d) If the business entity is a joint venture: Any individual who is entitled to receive, directly or
indirectly, income or benefit from the joint venture.
(e) If the business entity is a limited liability company:(A) Managers: Any individual who is a manager of the limited liability company and who receives
compensation for acting in that capacity  or who  owns  5 percent or more of  the ownershipinterests of the limited liability company and any individual who owns, directly or indirectly, 10percent or more of the ownership interests of a business entity that is a manager of the limitedliability company and that receives compensation for acting in that capacity or owns 5 percent or
more of the ownership interests of the limited liability company.
(B) Members: Any individual who is a member of the limited liability company and who owns 10
percent or more of the ownership interests of the limited liability company and any individual whoowns, directly or indirectly, 10 percent or more of the ownership interests of a business entity thatis a member of the limited liability company and that owns 10 percent or more of the ownershipinterests of the limited liability company.
(f) Immediate family members: Any person, 18 years of  age or older, involved in a marijuana
processing site or dispensary, in any capacity, who is a member of the immediate family of any
individual who  otherwise has a financial interest in the business entity that owns the marijuanaprocessing site or dispensary. A person is a member of the immediate family of the individual ifthe person receives more than 50 percent of his or her financial support from that individual.
(g) Landlord: Any individual who is a landlord of  a processing site or dispensary and who is
entitled to receive 40 percent or more of the proceeds from the marijuana processing site ordispensary as a part of lease payments or rent, any individual who owns, directly or indirectly, 10percent or more of the ownership interests of a business entity that is a landlord of a processing
site or dispensary and that is entitled to receive 40 percent or more of the proceeds from the
marijuana processing site or dispensary as part of lease payments or rent, and any individual whothe Authority finds, based on reasonably reliable information, exerts influence over the operationof the marijuana processing site or dispensary through a landlord-tenant relationship and receivesa portion of the proceeds from that marijuana processing site or dispensary.
(h) Other forms of business organization: If the form of business entity is not expressly addressed
in subsections (a) to (g) of this section, the Authority will, in determining individuals who have a
financial interest in the business entity, apply the portions of  this definition applicable to  the
business entity that are most similar to the subjec t business entity, interpreting the terminology and
concepts  of  this  definition in the  context  of  the  subject  business  entity  as  necessary  orappropriate.
(30) “Indoor production” for purposes of OAR 333-008-0580 means producing marijuana in any
manner:
(a) Utilizing artificial lighting on mature marijuana plants; or
(b) Other than “outdoor production” as that is defined in this rule.
(31) “Limited access area” means:(a) For a dispensary a building, room, or other contiguous area on a dispensary premises where a
marijuana item is present but does not include the area where marijuana items are transferred to apatient or designated primary caregiver.
(b) For a processing site a building, room, or other contiguous area on a processing site premises
where a marijuana item is present.
(32)(a) “Marijuana” means the plant Cannabis family Cannabaceae, any part of the plant CannabisOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
38 of 100 8/11/2016 2:13 P Mfamily Cannabaceae and the seeds of the plant Cannabis family Cannabaceae.
(b) “Marijuana” does not include industrial hemp, as defined in ORS 571.300.(33) “Marijuana item” means marijuana, cannabinoid concentrates, cannabinoid extracts, medical
cannabinoid products, and immature marijuana plants.
(34) “Marijuana processing site” or “processing site” means a marijuana processing site registered
under ORS 475B.435 or a site for which an applicant has submitted an application for registrationunder ORS 475B.435.
(35) “Mature marijuana plant” means a marijuana plant that is not an immature marijuana plant.
(36)(a) “Medical cannabinoid product” means a cannabinoid edible and any other product intended
for human consumption or use, including a product intended to be applied to  a person’s skin orhair, that contains cannabinoids or dried leaves or flowers of marijuana.
(b) “Medical cannabinoid product” does not include:(A) Usable marijuana by itself;
(B) A cannabinoid concentrate by itself;
(C) A cannabinoid extract by itself; or(D) Industrial hemp, as defined in ORS 571.300.(37) “Medical marijuana dispensary” means a medical marijuana dispensary registered under ORS
475B.450 or a site for which an applicant has submitted an application for registration under ORS475B.450.
(38) “Medical use of  marijuana” means  the production,  processing,  possession,  delivery,  or
administration of marijuana, or use of paraphernalia used to administer marijuana to mitigate the
symptoms or effects of a debilitating medical condition.
(39) “Minor” means an individual under the age of 18.(40) “Oregon Health Plan (OHP)” means the medical assistance program administered by the
Authority under ORS chapter 414.
(41) “OMMP” means the section within the Authority that administers the provisions of  ORS
475B.400  to  475B.525,  the  applicable  provisions  of  475B.550  to  475B.590,  475B.600  to
475B.655, and the rules in OAR chapter 333, divisions 7 and 8.
(42) “Outdoor production” for purposes of OAR 333-008-0580 means producing marijuana:(a) In an expanse of open or cleared ground open to the air; or(b) In a greenhouse, hoop house or similar non-rigid structure that does not utilize any artificial
lighting on mature marijuana plants, including but not limited to electrical lighting sources.
(43) “Parent or legal guardian” means the custodial parent or legal guardian with responsibility for
health care decisions for the person under 18 years of age.
(44) “Patient” has the same meaning as “registry identification cardholder.”
(45) “Person designated to produce marijuana by a registry identification cardholder” or “person
designated to produce marijuana by a patient” mean a person designated to produce marijuana bya patient under ORS 475B.420 who produces marijuana for that patient at an address:
(a) Other than the address where the patient resides; or(b) Where more than 12 mature marijuana plants are produced.(46) “Person responsible for a marijuana grow site,” or “PRMG” mean any individual designated
by a patient to produce marijuana for the patient, including a patient who identifies him or herself
as a person responsible for the marijuana grow site.
(47) “Personal agreement” means a document, as described in ORS 475B.425 signed and dated
by a patient, assigning a patient’s right to possess seeds, immature marijuana plants and usablemarijuana to a PRMG.
(48) “Point of sale” means a specific location within a point of sale area at which the transfer of a
marijuana item occurs.
(49)  “Point  of  sale  area”  means  a  secure  area  where  a  registered  dispensary  transfers  a
marijuana item to a patient or caregiver.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
39 of 100 8/11/2016 2:13 P M(50) “Premises” means a location registered by the Authority as a processing site or dispensary
under these rules and includes all areas at the location that are used in the business operated atthe location, including offices, kitchens, rest rooms and storerooms, including all public and privateareas where individuals are permitted to be present.
(51) “Primary responsibility” as that term is used in relation to an attending physician means that
the physician:
(a) Provides primary health care to the patient; or
(b) Provides medical specialty care and treatment to the patient as recognized by the American
Board of Medical Specialties; or
(c) Is a consultant who has been asked to examine and treat the patient by the patient’s primary
care physician licensed under ORS chapter 677, the patient’s physician assistant licensed underORS chapter 677, or the patient’s nurse practitioner licensed under ORS chapter 678; and
(d) Has  reviewed a patient’s  medical records  at  the patient’s  request  and has  conducted a
thorough physical examination of the patient, has provided or planned follow-up care, and has
documented these activities in the patient’s medical record.
(52) “Process” means the compounding or conversion of  marijuana into  medical cannabinoid
products, cannabinoid concentrates or cannabinoid extracts.
(53) “Production” or “growing” means:(a) Planting, cultivating, growing, trimming or harvesting marijuana; or(b) Drying marijuana leaves or flowers.(54)  “Registry  identification card”  means  a  document  issued  by  the  Authority  under  ORS
475B.415 that identifies a person authorized to engage in the medical use of marijuana, and, if the
person has  a  designated  primary  caregiver  under  ORS  475B.418,  the  person’s  designatedprimary caregiver.
(55) “Registry identification cardholder” means a person to whom a registry identification card has
been issued under ORS 475B.415(5)(a) and has the same meaning as patient.
(56) “Remuneration” means compensation resulting from the employer-employee relationship,
including wages, salaries, incentive pay, sick pay, compensatory pay, bonuses, commissions,
stand-by pay, and tips.
(57) “Replacement card” means a new card issued in the event that:(a)  A  patient’s  registry  identification card,  a  designated  primary  caregiver’s  or  a  PRMG’s
identification card, or grow site registration card is lost or stolen; or
(b) A patient’s designation of primary caregiver, PRMG or grow site has changed.(58) “Resident” means an individual who has primary domicile within this state.(59) “Safe” means:
(a) A metal receptacle with a locking mechanism capable of  storing all usable marijuana at a
registered premises that:
(A) Is rendered immobile by being securely anchored to a permanent structure of the building; or(B) Weighs more than 750 pounds.(b) A vault; or(c) A refrigerator or freezer capable of being locked for storing edibles or other finished products
that require cold storage that:
(A) Is rendered immobile by being securely anchored to a permanent structure of the building; or(B) Weighs more than 750 pounds; and(C) If  it has a glass that makes up part or all of  the door or exterior walls, the glass is rated
unbreakable.
(60) “Secondary school” means a learning institution containing any combination of  grades 9
through 12 and includes those institutions that provide junior high schools which include 9th grade.
(61) “Secure area” means a room:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
40 of 100 8/11/2016 2:13 P M(a) With doors that are kept locked and closed at all times except when the doors are in use;
(b) Where access is only permitted as authorized in these rules; and(c) Not visible from outside the room or within public view.(62)  “Supplemental  Security  Income  (SSI)”  means  the  monthly  benefit  assistance  program
administered by the federal government for persons who are age 65 or older, or blind, or disabledand who have limited income and financial resources.
(63) “These rules” means OAR 333-008-0010 to 333-008-0750.
(64) “THC” means tetrahydrocannabinol.(65)(a) “Usable marijuana” means the dried leaves and flowers of marijuana.(b) “Usable marijuana” does not include:(A) The seeds, stalks and roots of marijuana; or(B) Waste material that is a by-product of producing marijuana.(66) “Vault” means an enclosed area that is constructed of steel-reinforced or block concrete and
has a door that contains a multiple-position combination lock or the equivalent, a relocking device
or equivalent, and a steel plate with a thickness of at least one-half inch.
(67) “Written documentation” means a statement signed and dated by the attending physician of a
person diagnosed with a debilitating medical condition or copies of the person’s relevant medicalrecords, maintained in accordance with standard medical record practices.
(68) “Zoned for residential use” means the only primary use allowed outright in the designated
zone is residential.
Stat. Auth.: ORS 475B.525
Stats. Implemented: ORS 475B.400 – 475B.525Hist.: OHD 15-1998(Temp), f. &  cert. ef. 12-24-98 thru 6-22-99; OHD 3-1999, f. &  cert. ef.
4-29-99; OHD 13-2000(Temp), f. & cert. ef. 12-21-00 thru 6-15-01; OHD 18-2001, f. & cert. ef.8-9-01;  OHD  19-2001(Temp),  f.  &  cert.  ef.  8-10-01  thru 1-31-02;  Administrative  correction3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 9-2003, f. 6-26-03, cert. ef. 7-1-03; PH 18-2005,f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef.
9-13-10; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 8-2011, f. 9-30-11, cert. ef.
10-1-11; PH 1-2014, f. & cert. ef. 1-13-14; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru7-13-14; PH  20-2014, f. &  cert. ef. 7-11-14; PH  16-2015(Temp), f. &  cert. ef. 9-22-15 thru3-19-16; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0020
New Registry Identification Card Application Process
(1) To apply for a registry identification card an individual must submit the following:(a) An application form, prescribed by the Authority, signed and dated by the applicant.(b) A legible copy of  the individual’s valid government issued photographic identification that
includes the applicant’s last name, first name, and date of birth.
(c) An APS or written documentation that may consist of  relevant portions of  the applicant’s
medical record, signed by the applicant’s attending physician within 90 days of the date of receiptby the Authority, which describes the applicant’s debilitating medical condition and states that theuse of  marijuana may mitigate the symptoms or effects of  the applicant’s debilitating medicalcondition.
(d) Proof of residency in accordance with OAR 333-008-0022.(e) If applicable, a completed and notarized “Declaration of Person Responsible for Minor” form
for a person under 18 years of age, signed and dated by the minor’s parent or legal guardian.
(f) An application fee as specified in OAR 333-008-0021.
(g) If applicable, documentation required in OAR 333-008-0021 to qualify for a reduced fee.(2) If the applicant is designating a primary caregiver, the applicant must complete the caregiver
portion of the application and submit a legible copy of the designated primary caregiver’s validgovernment issued photographic identification that includes the caregiver’s last name, first name,and date of  birth.  The applicant  may  also  designate an organization that  provides  hospice,Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
41 of 100 8/11/2016 2:13 P Mpalliative or home health care services, or a residential facility as defined in ORS 443.400, under
ORS 475B.419, as an additional caregiver.
(3) If an applicant intends to produce marijuana for him or herself or designate another person to
produce marijuana for him or her, the applicant or the individual designated to be the PRMG mustcomplete the grow site registration portion of the application and submit:
(a) A legible copy of the designated PRMG’s valid government issued photographic identification
that includes the last name, first name, and date of birth.
(b) The grow site address.
(c) If the grow site is within city limits, documentation that shows the zoning designation for the
grow site address.
(d) Except for a patient producing marijuana for him or herself at his or her residence, the grow
site registration fee as specified in OAR 333-008-0021(4), unless the Authority has established anonline payment system for grow site registration in which case the fee must be paid online inaccordance with instructions from the Authority.
(4) If the Authority establishes an online payment system for payment of a grow site registration
fee  the  Authority  must  notify  the  person designated  on the  application as  the  PRMG  withinstructions for how to pay the fee online and the deadline by which the fee must be paid.
(5) Applications must be mailed to the address listed in section (6) of this rule or hand-delivered to
the OMMP dropbox at 800 N.E. Oregon St., Portland, Oregon 97232, unless the Authority hasestablished  an electronic  application process  at  which time  applications  and  accompanyingdocumentation must be submitted electronically.
(6)  The  application  forms  referenced  in  this  rule  may  be  downloaded  at
www.healthoregon.org/ommp or obtained by contacting OMMP at PO Box 14450, Portland, OR97293-0450 or by calling 971-673-1234.
(7) Acceptable forms of current government issued photographic identification include but are not
limited to:
(a) Driver’s license;(b) State identification card;
(c) Passport; or
(d) Military identification card.Stat. Auth.: ORS 475B.415, 475B.419, 475B.525Stats. Implemented: ORS 475B.415Hist.: OHD 3-1999, f. &  cert. ef. 4-29-99; OHD 13-2000(Temp), f. &  cert. ef. 12-21-00 thru
6-15-01; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 9-2003, f.
6-26-03, cert. ef. 7-1-03; PH 38-2004, f. 12-22-04, cert. ef. 1-1-05; PH 17-2005, f. 11-25-05, cert.
ef. 12-1-05; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08;PH 14-2010(Temp), f. & cert. ef. 7-6-10 thru 12-31-10; PH 27-2010, f. & cert. ef. 12-28-10; PH8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 9-2013(Temp), f. & cert. ef. 10-2-13 thru 3-30-14; PH1-2014, f. & cert. ef. 1-13-14; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH16-2014, f. & cert. ef. 6-5-14; PH 20-2014, f. & cert. ef. 7-11-14; PH 9-2016, f. 2-26-16, cert. ef.3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0021
Patient and PRMG New and Renewal Fees
(1) All fees referenced in this rule are non-refundable.
(2) New and Renewal Application Fee. A patient must pay a $200 application fee unless the
applicant qualifies for a reduced fee under section (3) of this rule.
(3) Reduced Fees.(a) An applicant receiving SSI benefits: $20. In order to qualify for the reduced fee the applicant
must submit at the time of application a copy of a current monthly SSI benefit statement showingdates of coverage.
(b) An applicant enrolled in OHP: $50. In order to qualify for the reduced fee the applicant must
submit a copy of the applicant’s current eligibility statement or card.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
42 of 100 8/11/2016 2:13 P M(c) An applicant receiving food stamp benefits through the Oregon SNAP: $60. In order to qualify
for the reduced fee the applicant must submit at the time of application current proof of his or herfood stamp benefits.
(d) An applicant who has served in the Armed Forces of the United States: $20. In order to qualify
for the reduced fee the applicant must provide proof of having served in the Armed Forces, suchas but not limited to, submitting a Veteran’s Administration form DD-214.
(4) Grow Site Registration Fee: $200.
(5) Replacement Card Fees. If a patient, designated primary caregiver or PRMG needs to obtain
a replacement card the fee is $100. If the patient qualifies for a reduced application fee of $20,the fee to receive any of the replacement cards is $20.
(6) All fees must be paid at the time a new or renewal application is submitted, or when an
application to add or change a PRMG is submitted under OAR 333-008-0047 and may be paid inthe form of bank check, money order, or personal check, unless the Authority has established anonline payment system in which case payments must be made online. The Authority does not
accept responsibility for payments that are lost in the mail or stolen in transit.
(7) The Authority shall notify an applicant who submits a reduced application fee if the applicant is
not eligible for the reduced fee and will allow the applicant 14 calendar days from the date ofnotice to pay the correct application fee or submit current valid proof of eligibility for a reducedfee.
Stat. Auth.: ORS 475B.415, 475B.420, 475B.525Stats. Implemented: ORS 475B.415
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0022Proof of Residency
(1) If an applicant for a registry identification card does not have a valid Oregon driver license or
Oregon identification card, the applicant must submit documentation that shows the applicant is aresident of Oregon, such as but not limited to a current lease agreement or current utility bill thathas the applicant’s name and address.
(2) Residency must be maintained by patients while registered with the Authority.Stat. Auth.: ORS 475B.415, 475B.420, 475B.525Stats. Implemented: ORS 475B.415
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0023Patient Application Review Process
(1) The Authority must review a patient application to determine if it is complete.
(a) If an applicant does not provide all the information required in OAR 333-008-0020 or pay the
applicable fee the Authority must notify the applicant of the information that is missing or the feethat was not paid, and allow the applicant 14 calendar days to submit the missing information.
(b) If an applicant does not provide the information requested in subsection (1)(a) of this rule the
application must be denied in accordance with OAR 333-008-0035.
(2) The  Authority  may  verify  the  information on each application,  verify  any  accompanying
documentation submitted with an application, or request additional information from the applicant
or other individuals named on the application.
(3) If the Authority is unable to verify that the applicant’s attending physician meets the definition
under OAR 333-008-0010 the applicant will be allowed 30 days to submit a new APS or writtendocumentation from a physician meeting the requirements of these rules. Failure to submit therequired attending physician documentation is grounds for denial under ORS 475B.415(8) andOAR 333-008-0035.
(4) If an applicant fails to submit information necessary for the Authority to verify information on
the application, fails to submit information necessary to verify any accompanying documentationsubmitted with an application, or fails to cooperate with the Authority in obtaining information,such as but not limited to refusing to sign an authorization for disclosure of medical records withintimeframes established by the Authority, the Authority will reject the application as incomplete.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
43 of 100 8/11/2016 2:13 P M(5) An applicant whose application is rejected as incomplete may reapply at any time. If  the
individual reapplies within a year the application fee may be applied toward a new application.
(6) Upon receipt of a complete application, including payment of the required application fee, the
Authority must issue a receipt to the applicant verifying that a complete application has beenreceived. A receipt issued under this section has the same legal effect as a registry identificationcard for 30 days following the date on which the receipt was issued to the applicant.
(7) The Authority shall approve or deny an application within 30 days after receiving a complete
application.
Stat. Auth.: ORS 475B.415, 475B.525Stats. Implemented: ORS 475B.415Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0025
Person Responsible for a Marijuana Grow  Site Criteria; Grow  Site Registration Application
Review Process
(1) In order to be a PRMG an individual must:
(a) Be 21 years of age or older.
(b) Not have been convicted of a Class A or Class B felony under ORS 475.752 to 475.920 for
the manufacture or delivery of a controlled substance in Schedule I or Schedule II:
(A) Within the previous two years; or(B) More than once.(2) In addition to the application review required in OAR 333-008-0023 the Authority must:
(a) Conduct a criminal background check on any PRMG.
(b) Verify the PRMG’s age.(c) Verify the zoning of the grow site address if the grow site is within city limits.(d) Determine the number of plants that are permitted at the grow site address.(3) Unless the Authority has received a request for a grandfathered grow site address under OAR
333-008-0500, the grow site plant limits, on and after March 1, 2016, are as follows:
(a) A maximum of 12 mature marijuana plants if the grow site location is within city limits and
zoned residential; or
(b) A maximum of 48 mature marijuana plants if the grow site location is within city limits but not
zoned residential or outside city limits.
(4) The Authority must notify a patient if  a PRMG or a grow site address is ineligible for
registration and the patient will be allowed 14 calendar days to identify another PRMG or growsite address in accordance with OAR 333-008-0047.
Stat. Auth.: ORS 475B.420, 475B.525
Stats. Implemented: ORS 475B.420
Hist.: PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH
8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14;PH 20-2014, f. & cert. ef. 7-11-14; PH 16-2015(Temp), f. & cert. ef. 9-22-15 thru 3-19-16; PH9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0033
Approval of New or Renewal PRMG and Grow Site Application; Change of PRMG
(1) The Authority must register a PRMG and a grow site address listed on an application if:(a) The PRMG:(A) Meets the age requirements;
(B) Passes the criminal background check;
(C) Has not violated a provision of ORS 475B.400 to 475B.525, ORS 475B.580, ORS 475B.650,Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
44 of 100 8/11/2016 2:13 P MOAR chapter 333, division 7, these rules, or an ordinance adopted pursuant to ORS 475B.500;
and
(D) Pays the applicable fee.(b) The grow site address does not exceed the plant limits in ORS 475B.428(3) or (4).(2) If the Authority registers a marijuana grow site it will issue an identification card and a grow site
registration card that contains at least the following information:
(a) The PRMG’s name, address, date of birth, and identification card number.
(b) The effective date, date of issuance, and expiration date of the identification card.(c) The grow site address.(d) The patient’s registry identification card number.(3) A PRMG, except for a patient growing only for him or herself at his or her residence who is not
transferring  usable  marijuana,  seeds  or  immature  plants  to  a  registered  processing  site  ordispensary, must create an online account with the Authority through which the individual must at a
minimum submit the information required in OAR 333-008-0630.
(4) The Authority must notify a PRMG at the time the grow site is registered the current number of
mature marijuana plants permitted at the grow site address.
(5) The Authority  shall also  notify  a patient  if  the PRMG  and grow site address  has  been
approved.
(6) The Authority may only register one grow site per patient, and may only register grow sites in
Oregon.
Stat. Auth.: ORS 475B.420, 475B.525
Stats. Implemented: ORS 475B.420Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0037
Denial of Designation of Caregiver or Person Responsible for a Marijuana Grow Site; Denial
of Grow Site Registration
(1) The Authority may deny a designation of a primary caregiver made under ORS 475B.418 if
the Authority determines that the designee or the patient violated a provision of ORS 475B.400 to
475B.525, ORS 475B.580, 475B.650, OAR chapter 333, division 7, these rules, or an ordinance
adopted pursuant to ORS 475B.500.
(2) A person whose designation has been denied may not be designated as a primary caregiver
under ORS 475B.418 for six months from the date of the denial unless otherwise authorized bythe Authority.
(3) The Authority  may  deny  a designation of  a PRMG if  the Authority  determines  that the
applicant or the PRMG violated a provision of ORS 475B.400 to 475B.525, 475B.580, 475B.650,OAR chapter 333, division 7, these rules, or an ordinance adopted pursuant to ORS 475B.500.
(4) The Authority may deny the registration of a PRMG and grow site address if the grow site
registration fee has not been paid.
Stat. Auth.: ORS 475B.415, 475B.420 & 475B.525Stats. Implemented: ORS 475B.415, 475B.420Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0040
Annual Renewal
(1) A patient shall register on an annual basis to maintain active registration status by submitting:(a) A renewal application prescribed by the Authority;
(b) An APS signed by the patient’s attending physician within 90 days prior to the expiration date
of the patient’s current card, reconfirming the patient’s debilitating medical condition and that themedical use of marijuana mitigates the symptoms of the patient’s debilitating medical condition;andOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
45 of 100 8/11/2016 2:13 P M(c) The additional information and fees required in OAR 333-008-0020.
(2) A renewal application may be submitted by mail at PO Box 14450, Portland, OR 97293-0450
or in person at the OMMP drop box located at 800 N.E. Oregon St., Portland, OR 97232.
(3) Between 60 to 90 calendar days prior to expiration, the Authority shall notify the patient of the
upcoming expiration date.
(4) If a renewal application and accompanying information is not received by the expiration date
on the patient’s card, the patient’s card and all other associated OMMP identification cards, if any,
are expired. The expiration date may be extended, due to personal hardship, at the discretion of
the Authority.
(5) Upon receipt of a complete renewal application, including payment of the required application
fee,  the  Authority  must  issue  a  receipt  to  the  applicant  verifying  that  a  complete  renewalapplication has been received. A receipt issued under this section has the same legal effect as aregistry identification card for 30 days following the date on which the receipt was issued to theapplicant.
(6) The Authority shall review and verify the renewal application information in the same manner
as specified in OAR 333-008-0023 and 333-008-0025 and shall approve or deny the application inaccordance with OAR 333-008-0030 to 333-008-0037, as applicable.
Stat. Auth.: ORS 475B.415, 475B.418, 475B.420, 475B.525Stats. Implemented: ORS 475B.415, 475B.418, 475B.420Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; PH 9-2003, f. 6-26-03, cert. ef. 7-1-03; PH 18-2005, f.
12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef.
9-13-10; PH 27-2010, f. & cert. ef. 12-28-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 9-2016,
f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0045
Notification of Changes
(1) Patient notification responsibilities.(a) A patient must notify the Authority within 10 calendar days of any change in the patient’s name,
mailing  address,  electronic  mail address,  telephone  number,  attending  physician,  designatedprimary caregiver, PRMG, grow site address or residency, on a form prescribed by the Authority.
(b) If the patient is designating a caregiver for the first time or designating a different caregiver,
the patient must include all the information and documentation specified in the form and required
under OAR 333-008-0020.
(c) If a patient is adding or changing a PRMG or grow site address the patient must comply with
OAR 333-008-0047.
(2)  Caregiver  notification  responsibilities.  A  designated  primary  caregiver  must  notify  the
Authority within 10 calendar days of any change in the caregiver name, mailing address, electronicmail address, or telephone number.
(3) Person responsible for a marijuana grow site notification responsibilities. A PRMG must notify
the Authority within 10 calendar days of:
(a) Any change in the person’s name, mailing address, electronic mail address, or telephone
number.
(b)  A  conviction of  a  Class  A  or  Class  B  felony  under  ORS  475.752  to  475.920  for  the
manufacture or delivery of a controlled substance in Schedule I or Schedule II.
(4) If the Authority is notified by the patient that the patient has terminated the designation of a
primary caregiver or a PRMG the Authority must notify the individuals confirming the termination,informing the individual that his or her card is no  longer valid, and requesting that the card be
returned to the Authority within seven calendar days. In addition the Authority must notify the
PRMG whether the termination affects the person’s ability to produce marijuana for other patientsat the grow site address, in accordance with ORS 475B.428(6).
(5) Change in Medical Condition.(a) If  an attending physician notifies the Authority that a patient no  longer has a debilitating
medical condition or that that the medical use of marijuana is contraindicated for the patient’sdebilitating medical condition, the Authority  must notify  the patient that the patient’s registry
identification card will be invalid 30 days from the date of  the notification unless the patient
submits within 30 calendar days an APS or written documentation that may consist of relevantOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
46 of 100 8/11/2016 2:13 P Mportions of the individual’s medical record, signed by the individual’s attending physician within the
previous 90 days, which states the individual has been diagnosed with a debilitating medicalcondition and that the use of marijuana may mitigate the symptoms or effects of the individual’sdebilitating medical condition.
(b) If, due to  circumstances beyond the patient’s control he or she is unable to  submit the
documentation in subsection (a) of  this section, the Authority may, upon receiving a writtenrequest  from  the  patient,  grant  the  patient  additional time  to  obtain a second  opinion.  The
Authority  must  notify  the  patient  how  much additional  time  the  patient  has  to  submit  the
documentation.
(6) If  a patient does not intend to  submit the information or does not submit the information
required in section (5) of this rule within the timeframes established by the Authority, the Authoritymust notify:
(a) The patient that the patient’s card must be returned within seven calendar days; and(b) If applicable, the patient’s designated primary caregiver and PRMG that those identification
cards must be returned within seven calendar days.
(7)  The  Authority  will  review  and  deny  a  caregiver  designation or  register  a  caregiver  in
accordance with OAR 333-008-0023 to 333-008-0037, as applicable.
(8) Change forms may only be submitted to the Authority via mail at PO Box 14450, Portland, OR
97293-0450 or in person at the OMMP drop box located at 800 N.E. Oregon St., Portland, OR97232 and must be accompanied by any applicable fee as specified in OAR 333-008-0021.
Stat. Auth.: ORS 475.309 & 475.312
Stats. Implemented: ORS 475.309 & 475.312
Hist.: PH 27-2010, f. & cert. ef. 12-28-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 1-2014, f.
& cert. ef. 1-13-14; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 20-2014, f. &cert. ef. 7-11-14; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0080
Permissible Amounts of Medical Marijuana for Patients and Caregivers
(1) A patient or the patient’s designated primary caregiver may jointly possess up to six mature
marijuana plants and 24 ounces of usable marijuana.
(2)  A  patient  or  the  patient’s  designated  primary  caregiver  may  only  possess  cannabinoid
products, concentrates or extracts in the amounts described in ORS 475B.245.
(3) A patient and designated primary caregiver must have, in his or her possession, his or her
registry identification card or OMMP identification card when transporting marijuana.
(4) A patient must have, in his or her possession, his or her registry identification card when using
marijuana in a location other than the residence of the cardholder.
Stat. Auth.: ORS 475B.430Stats. Implemented: ORS 475B.430Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 18-2001, f. & cert. ef. 8-9-01; PH 18-2005, f.
12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef.
9-13-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11.; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0500
Request for Grandfathered Grow Site
(1) An individual or group of  individuals may submit a petition, on a form prescribed by the
Authority, requesting that a grow site address be approved as a grandfathered grow site.
(2) A petition submitted under section (1) of this rule must include:(a) For all individuals currently growing at the grow site address:(A) Names and contact information.
(B) Copies of legible and valid government issued photographic identification that includes last
name, first name, and date of birth.
(C) Copies of  all current grow site registration cards issued to  the PRMG for the grow siteOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
47 of 100 8/11/2016 2:13 P Maddress.
(D) An attestation that the PRMG was registered at the grow site address on December 31, 2014,
and has continuously been registered at the grow site address since that date.
(b) The physical address of the grow site where marijuana is being produced or intending to be
produced.
(c) Documentation from a local government that indicates whether the address is within city limits
and if so, the zoning designation for the address.
(d) The names and registry identification card numbers for all patients for whom each PRMG is
producing at the grow site address.
(e) How many patients each PRMG was growing for on December 31, 2014.(3) A petition that does not contain all the required information or is not accompanied by all of the
documentation required to  be submitted in section (2) of  this rule is incomplete and will bereturned to the applicant.
(4) A petition that does not include all the PRMGs currently growing at the grow site address may
be considered by the Authority to be incomplete and may be returned to the applicant.
(5) Acceptable forms of current government issued photographic identification include but are not
limited to:
(a) Driver’s license;(b) State identification card;(c) Passport; or
(d) Military identification card.
Stat. Auth.: ORS 475B.525Stats. Implemented: ORS 475B.428Hist.: PH 33-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 2-29-16; PH 9-2016, f. 2-26-16, cert.
ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0510
Review of Petition For Grandfathered Grow Site
(1) Once the Authority has determined that a petition is complete it must:(a) Conduct a criminal background check on all PRMGs listed on the application;(b) Verify that:
(A) Each person listed on the application is 21 years of age or older;
(B) Each person has a current valid registration card and is currently registered at the grow site
address;
(C) All the patients listed on the application have valid cards; and(D) All persons were registered with the Authority on December 31, 2014, at the grow site address
listed on the application and have been continuously registered at the grow site since the petitionwas submitted; and
(c) Verify the number of patients each PRMG was producing marijuana for, at that address on
December 31, 2014.
(2) If a PRMG listed on a petition does not meet the age requirements or is disqualified to be a
PRMG based on criminal convictions, the Authority must notify:
(a) The PRMG that his or her designation is revoked; and(b) The patient that the patient’s PRMG is ineligible and that the patient may submit a change
form, in accordance with OAR 333-008-0047 designating a new PRMG and grow site address.
Stat. Auth.: ORS 475B.525
Stats. Implemented: ORS 475B.428Hist.; PH 33-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 2-29-16; PH 9-2016, f. 2-26-16, cert.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
48 of 100 8/11/2016 2:13 P Mef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0540Requirements  for  Grandfathered  Grow  Sites;  Termination  of  PRMG  Designation;
Suspension or Revocation of PRMG Registration
(1) A grandfathered grow site may only have the number of plants authorized by the Authority,
based on the number of patients designating the address as a grow site on December 31, 2014.A PRMG producing marijuana at a grandfathered grow site may replace an existing patient with anew patient unless the person’s designation has been terminated under ORS 475B.428(6).
(2) If the Authority suspends or revokes the registration of a PRMG that is producing marijuana at
a grandfathered grow site the PRMG may not continue to grow at that address or any other growsite address that has more than:
(a) 12 mature marijuana plants if the location is within city limits and zoned residential; or(b) 48 mature marijuana plants if the location is within city limits but not zoned residential or not
within city limits.
(3) If  a patient terminates the designation of  a PRMG that person may not be designated to
produce  marijuana  by  another  patient  at  the  grandfathered  grow site  address  and may  not
produce marijuana at any other grow site address that is authorized to have more than 48 maturemarijuana plants.
(4) Approval of a grandfathered grow site is terminated once the number of mature marijuana
plants, based on number of PRMGs who have been authorized to produce medical marijuana atthe grow site address and the number of patients each person is producing for is less than:
(a) 12 mature marijuana plants if the location is within city limits and zoned residential; or
(b) 48 mature marijuana plants if the location is within city limits but not zoned residential or not
within city limits.
Stat. Auth.: ORS 475B.525Stats. Implemented: ORS 475B.428Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0550
General Person Responsible for a Marijuana Grow Site Requirements
(2) A PRMG must display a marijuana grow site registration card at the marijuana grow site at all
times for each patient for whom marijuana is being produced.
(3)  All  seeds,  immature  marijuana  plants,  mature  marijuana  plants  and  usable  marijuana
associated with the production of marijuana for a patient by a PRMG are the property of the
patient and must be provided to  the patient upon request, unless the patient has assigned aportion of the right to possess the seeds, immature plants and usable marijuana to the PRMG inaccordance with ORS 475B.425.
(4) All marijuana produced for a patient must be provided to the patient or designated primary
caregiver when the PRMG ceases producing marijuana for the patient, unless the patient hasassigned a portion of the right to possess the seeds, immature plants and usable marijuana to the
PRMG in accordance with ORS 475B.425.
(5) All usable  marijuana  associated  with the  production of  marijuana  for a  patient  must  be
transferred to a marijuana processing site upon the patient’s request.
(6) All seeds, immature marijuana plants and usable marijuana associated with the production of
marijuana for a patient must be transferred to a medical marijuana dispensary upon the patient’srequest.
(7) If  a patient terminates the designation of  a PRMG that PRMG may not be designated to
produce marijuana by another patient unless the grow site address is authorized to have no more
than 48 mature marijuana plants.
(8) A  PRMG must return the grow site registration card to  the Authority when the person’s
designation has been terminated by a patient or the person ceases producing marijuana for him orherself or another patient.
(9) A PRMG registered with the Authority, except for a patient growing only for him or herself at
his or her own residence and not transferring usable marijuana, seeds or immature plants to aOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
49 of 100 8/11/2016 2:13 P Mregistered processing site or dispensary, must create an online account with the Authority through
which the individual must at a minimum submit the information required in OAR 333-008-0630.
(10) A  PRMG must comply with the advertising restrictions in OAR 333-008-2070 and must
remove any sign, display or advertisement if the Authority determines the PRMG has violatedOAR 333-008-2070.
Stat. Auth.: ORS 475B.420 - 475B.428, 475B.525Stats. Implemented: ORS 475B.420 - 475B.428
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0560Grow Site Plant Limits
(1) A PRMG may not produce more than six mature marijuana plants per patient.
(2) Unless a petition has been granted under OAR 333-008-0520 or except as authorized under
Oregon Laws 2016, chapter 83, section 2, a grow site address may not have more than:
(a) 12 mature marijuana plants if the location is within city limits and zoned residential; or(b) 48 mature marijuana plants if the location is within city limits but not zoned residential or not
within city limits.
(3) For purposes of  determining plant limits the Authority presumes that a PRMG grows six
mature plants for each patient.
Stat. Auth.: ORS 475B.428, 475B.525Stats. Implemented: ORS 475B.428Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0570
Designation of Plants at Grow Site Address
(1) A PRMG producing marijuana at a grow site where multiple PRMGs are registered must
physically identify the marijuana plants at a grow site address that are being grown by that PRMGby either:
(a) Tagging each marijuana plant with the PRMG’s name, identification card number and patient
identification number; or
(b) Fencing or cordoning off the PRMG’s marijuana plants and posting all grow site registration
cards at the location where the plants are located.
(2)  If  during  an investigation the  Authority  determines  that  marijuana  plants  have  not  been
designated by a PRMG in accordance with section (1) of this rule or there are marijuana plants atthe grow site designated by an individual who is not authorized to produce marijuana at that grow
site the Authority may suspend or revoke the registration of the grow site address for all PRMGs
at that grow site and all the PRMG’s identification cards.
(3) If during an investigation the Authority determines that a PRMG is producing marijuana plants
in excess of the number of plants allowed in ORS 475B.428 the Authority may suspend or revokethe registration of the PRMG for each patient who has designated the PRMG.
Stat. Auth.: ORS 475B.428, 475B.525Stats. Implemented: ORS 475B.428
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-0630PRMG Documentation Requirements
(1) The reporting requirements in this rule do not apply to a patient growing only for him or herself
at  his  or  her  residence,  unless  the  patient  is  transferring  usable  marijuana  to  a  registeredprocessing site or dispensary.
(2) Beginning in June 2016, and on a monthly basis thereafter, no later than the 10th day of each
month, a PRMG, who is not a person designated to produce marijuana by a patient, as that isdefined in OAR 333-008-0010, must submit the following information to the Authority:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
50 of 100 8/11/2016 2:13 P M(a) The  number  of  immature  and  mature  marijuana  plants  and  amount  of  usable  marijuana
transferred to each patient for whom the PRMG is producing marijuana;
(b) The amount of  usable marijuana transferred to  each registered marijuana processing site
through an agreement with the patient; and
(c) The number of seeds or immature plants and the amount of usable marijuana transferred to
each registered dispensary through an agreement with the patient.
(3) Beginning in June 2016, and on a monthly basis thereafter, no later than the 10th day of each
month, a person designated to produce marijuana by a patient as that term is defined in OAR
333-008-0010, must submit the following information to the Authority:
(a)  The  number  of  mature  marijuana  plants  and  immature  marijuana  plants,  the  amount  of
marijuana leaves and flowers being dried, and the amount of usable marijuana, in the person’spossession;
(b) The number of mature marijuana plants and immature marijuana plants, and the amount of
usable marijuana transferred to each patient for whom the person produces marijuana, or that
patient’s designated primary caregiver during the previous month;
(c) The amount of  usable marijuana transferred to  each marijuana processing site during the
previous month; and
(d) The number of immature marijuana plants, and the amount of usable marijuana transferred to
each medical marijuana dispensary during the previous month.
(4) The information required to be submitted under this rule must be submitted electronically in a
manner prescribed by the Authority.
(5) In addition to  submitting the information as required in section (3) of  this rule a person
designated to produce marijuana by a patient must keep a record of the information described insection (3) of this rule for two years after the date on which the person submits the information tothe Authority.
(6) A person designated to  produce marijuana by a patient, as that term is defined in OAR
333-008-0010, may delegate his or her duty to report information under section (3) of this rule toanother person designated to produce marijuana by a patient if the marijuana grow site addressesare the same.
(a) The person to whom the duty is delegated must submit a notice, on a form prescribed by the
Authority, of the delegation.
(b) A delegation under this section does not relieve a person designated to produce marijuana by
a patient, who delegates the duty to report, from complying with any of these rules, except for theduty to report.
(c) If a person to whom the reporting duty has been delegated fails to report in accordance with
section (3) of this rule the Authority may suspend or revoke the registration of the person to whom
the reporting duty was delegated.
(d) If the person to whom the reporting duty has been delegated fails to report in accordance with
section (3) of this rule for any person designated to produce marijuana by a patient the delegationis void and the person who  delegated the reporting duty must report the information to  theAuthority within 10 business days of being informed by the Authority of the failure to report.
Stat. Auth.: ORS 475B.420, 475B.423, 475B.525Stats. Implemented: ORS 475B.420, 475B.423
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1000Applicability
(1) A person may not establish, conduct, maintain, manage or operate an establishment for the
purpose of providing the services in ORS 475B.450(1)(a) unless the person is registered by theAuthority under these rules.
(2) Nothing in these rules exempts a dispensary registrant or dispensary representative from
complying with any other applicable state or local laws.
(3)  Registration  of  a  dispensary  does  not  protect  a  dispensary  registrant  or  dispensary
representative from possible criminal prosecution under federal law.
(4) Registration by the Authority is not a guarantee that a dispensary is permitted to operate underOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
51 of 100 8/11/2016 2:13 P Mapplicable land use or other local government laws where the dispensary is located.
(5) These rules apply to any initial or renewal application filed on or after June 24, 2016, and to
any application filed prior to June 24, 2016 that the Authority has not approved or denied.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 20-2014, f. & cert. ef.
7-11-14; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1020Application for Medical Marijuana Dispensary Registration
(1) To register a medical marijuana dispensary a person must:
(a) Submit an initial application on a form prescribed by the Authority that includes but is not
limited to:
(A) The name of  the individual who  owns  the dispensary  or,  if  a business  entity  owns  the
dispensary, the name of each individual who has a financial interest in the dispensary;
(B) The name of the individual or individuals responsible for the dispensary, if different from the
name of the individual who owns the dispensary, with one of the individuals responsible for the
dispensary identified as the primary PRD;
(C) The physical and mailing address of the medical marijuana dispensary; and(b) Application and registration fee.(2) An initial application for the registration of a dispensary must be submitted electronically via
the Authority’s website, www.healthoregon.org/ommp.
(3) If an initial application is submitted along with the required fees the Authority will notify the
applicant in writing that the application has been received and that within 30 calendar days of the
date the written notice is mailed the following information must be received by the Authority:
(a) For each individual named in the application:(A) A legible copy of  the individual’s valid government issued photographic identification that
includes last name, first name and date of birth;
(B) Information, fingerprints and fees required for a criminal background check in accordance with
OAR 333-008-2020; and
(C) An Individual History Form and any information identified in the form that is required to be
submitted;
(b) A written statement from an authorized official of  the local government that the proposed
location of the dispensary is not located in an area that is zoned for residential use as that term isdefined in OAR 333-008-0010;
(c) Proof that the business is registered or has filed an application to register as a business with
the Oregon Office of the Secretary of State, including proof of registration for any DBA (doingbusiness as) registration;
(d) Documentation, in a format prescribed by the Authority that the proposed location of  the
dispensary is not within 1,000 feet of:
(A) The real property comprising a public or private elementary or secondary school, except as
provided in Oregon Laws 2016, chapter 83, section 29; or
(B) A registered dispensary.(e) A scaled site plan of the parcel on which the premises proposed for registration is located,
including:
(A) Cardinal directional references;
(B) Bordering streets and the names of the streets;(C) Identification of the building or buildings in which the proposed dispensary is to be located;(D) The dimensions of the proposed premises of the dispensary;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
52 of 100 8/11/2016 2:13 P M(E) Identification of other buildings or property owned by or under the control of the applicant on
the same parcel or tax lot as the premises proposed for registration that will be used in thebusiness; and
(F) Identification of any residences on the parcel or tax lot; and(f) A scaled floor plan of all enclosed areas of the premises at the proposed location that will be
used in the business with clear identification of walls, partitions, counters, windows, all areas ofingress and egress, intended uses of all spaces and all limited access areas; and
(g) Documentation that shows the applicant has lawful possession of the proposed location of the
dispensary.
(4) The documentation required in section (3) of this rule may be submitted electronically to the
Authority or may be mailed to the Oregon Medical Marijuana Program, Oregon Health Authority,PO Box 14116, Portland, OR 97293.
(a) If documentation is mailed it must be received by the Authority within 30 calendar days of the
date the Authority mailed the notice to the applicant that the initial application was received or the
application will be considered incomplete.
(b) If documentation is submitted electronically it must be received by the Authority by 5 p.m.
Pacific Time within 30 calendar days of the date the Authority mailed the notice to the applicantthat the initial application was received. or the application will be considered incomplete.
(5) Application and registration fees must be paid online at the time of application.(6) Criminal background check fees must be paid by check or money order and must be mailed to
the Oregon Medical Marijuana Program, PO Box 14116, Portland, OR 97293, and must be
received by the Authority in accordance with provisions in section (4) of this rule.
(7) If the Authority does not receive a complete application, including all documentation required in
sections (1) and (3) of this rule, and all required fees within the time frames established in this rule,the application will be considered incomplete.
(8) If an applicant provides the documentation required in section (3) of this rule the Authority will
review the information to determine if it is complete.
(a) If the documentation is not complete or is insufficient the Authority must notify the applicant in
writing and the applicant will have 10 calendar days from the date such written notice is mailed by
the Authority to provide the additional documentation.
(b) If the applicant does not provide the additional documentation within 10 calendar days or if any
responsive documents are incomplete, insufficient or otherwise do not demonstrate compliancewith ORS 475B.450 and these rules the application will be declared incomplete.
(9) A person who wishes to register more than one location must submit a separate application,
registration fees, and all documentation described in sections (1) and (3) of this rule for eachlocation.
(10) An application that is incomplete is treated by the Authority as if it was never received.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 20-2014, f. & cert. ef.
7-11-14; PH 4-2015, f. & cert. ef. 1-28-15; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f.6-24-16, cert. ef. 6-28-16
333-008-1040
Dispensary Application Review
(1) Applications will be reviewed in the order they are received by the Authority. An application is
considered received as of the date and time that payment of application and registration fees is
authorized by the entity that issued the credit or debit card used to pay the fees.
(2) Once the Authority has determined that an application is complete it will review an application
to the extent necessary to determine compliance with ORS 475B.450 and these rules.
(3) The Authority may, in its discretion, prior to acting on an application:(a) Contact  any  individual listed on the application and request  additional documentation or
information;
(b) Inspect the premises of the proposed dispensary; orOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
53 of 100 8/11/2016 2:13 P M(c) Verify any information submitted by the applicant.
(3) Prior to making a decision whether to approve or deny an application the Authority must:(a) Review the criminal background check results for each individual named on the application;(b) Determine  whether the  proposed  location of  the  dispensary  is  the  same  location as  a
registered grow site under OAR 333-008-0025;
(c) Review documentation submitted by the applicant to  determine, based on the information
provided by the applicant, whether the proposed location of the dispensary is located within 1,000
feet of:
(A) The real property comprising a public or private elementary or secondary school, except as
provided in Oregon Laws 2016, chapter 83, section 29; or
(B) Another registered dispensary;(d) Verify that the applicant is registered as a business with the Office of the Secretary of State;
and
(e) Verify that the proposed location of the dispensary is not:
(A) Located in an area that is zoned for residential use; or(B) In a city or county that has adopted an ordinance under ORS 475B.800 or section 133 chapter
614, Oregon Laws 2015, prohibiting dispensaries.
(4) If  during  the  review process  the  Authority  determines  that  the  application or  supporting
documentation contains intentionally false or misleading information the Authority may declare theapplication incomplete or issue a notice of denial under OAR 333-008-1060.
(5) The Authority will notify the applicant in writing that the applicant has 60 calendar days from the
date of the written notice to submit a Readiness Form, prescribed by the Authority, indicating thatthe applicant is prepared for an inspection and is in compliance with these rules if:
(a) There is no basis for denial under OAR 333-008-1060;(b) The proposed dispensary is in compliance with ORS 475B.450(3)(a) through (e);(c) Each individual named in the application passes the criminal background check; and(d) Each individual named as a PRD in the application meets age requirements.
(6) If the Authority does not receive the Readiness Form in accordance with section (5) of this rule
the applicant’s application will be declared incomplete, unless an extension has been grantedunder section (7) of this rule.
(7) An applicant may request one extension of the 60-day deadline in section (5) of this rule if the
applicant can demonstrate to the Authority that the deadline cannot be met for reasons outside ofthe  applicant’s  control,  such  as  but  not  limited  to  the  applicant’s  inability  to  obtain  localgovernment building permits.
(a) A request for an extension must be in writing, must be received within 60 calendar days of the
notice described in section (5) of this rule and must explain and provide documentation that showsthe applicant cannot, for reasons outside of the applicant’s control, meet the 60-day deadline, andmust specify when the applicant believes it can submit the Readiness Form.
(b) A request for an extension tolls the 60-day deadline.(c) The Authority will review the request and provide, in writing to the applicant, its decision and
the reason for the decision.
(d) If  an extension is granted the Authority must inform the applicant of  the new deadline for
submission of the Readiness Form, but in any case an extension may not exceed 60 calendardays.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 20-2014, f. & cert. ef.
7-11-14; PH 4-2015, f. & cert. ef. 1-28-15; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f.6-24-16, cert. ef. 6-28-16
333-008-1060Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
54 of 100 8/11/2016 2:13 P MDenial of Dispensary Application
(1) The Authority must deny an application if:(a) An application, supporting documentation provided by the applicant, or other information
obtained by the Authority shows that the qualifications for a dispensary in ORS 475B.450 or theserules have not been met; or
(b) An individual named in an application has been:
(A) Convicted for the manufacture or delivery of a controlled substance in Schedule I or Schedule
II within two years from the date the application was received by the Authority; or
(B) Convicted more than once for the manufacture or delivery  of  a controlled substance in
Schedule I or Schedule II; or
(c) The city or county in which the facility is located has prohibited dispensaries in accordance
with sections 133 chapter 614, Oregon Laws 2015, or ORS 475B.800, unless the dispensary
meets the criteria in sections 133(6), chapter 614, Oregon Laws 2015 or ORS 475B.800(6).
(2) The Authority may deny an applicant if  it determines that the applicant, the owner of  the
dispensary, a PRD, or an employee of the medical marijuana dispensary:
(a) Submitted intentionally false or misleading information to the Authority; or(b) Violated  at  any  time a provision of  ORS  475B.400 to  475B.525,  475B.555,  475B.605,
475B.615, OAR chapter 333, division 7, these rules or an ordinance adopted pursuant to ORS475B.500.
(3)  If  an individual named  in an application is  not  qualified  based  on age  or  the  criminal
background check, the Authority will permit a change form to be submitted in accordance withOAR 333-008-1078 or 333-008-2030, along with the applicable criminal background check fee. Ifthe individual named in the change form is not qualified the Authority must deny the application inaccordance with section (1) of this rule.
(4) If  the Authority intends to  deny an application for registration it must issue a Notice of
Proposed Denial in accordance with ORS 183.411 through 183.470.
Stat. Auth.: ORS 475B.450 & 475B.525
Stats. Implemented: ORS 475B.450Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 20-2014, f. & cert. ef.
7-11-14; PH 4-2015, f. & cert. ef. 1-28-15; PH 16-2015(Temp), f. & cert. ef. 9-22-15 thru 3-19-16;PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1070
Expiration and Renewal of Dispensary Registration
(1) A dispensary’s registration expires one year following the date of application approval.(2) A dispensary registrant must submit not more than 90 but at least 30 calendar days before the
registration expires:
(a) A renewal application on a form prescribed by the Authority;
(b) Renewal fees;(c) For each individual named in the renewal application:(A) A legible copy of  the individual’s valid government issued photographic identification that
includes last name, first name and date of birth;
(B) Information, fingerprints and fees required for a criminal background check in accordance with
OAR 333-008-2020;
(C) An Individual History Form and any information identified in the form that is required to be
submitted;
(d) Current proof of business registration with the Secretary of State, including all DBA (doing
business as) registrations;
(e) Documentation that shows the applicant has lawful possession of the location of the registered
dispensary; and
Any information required during an initial application; andOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
55 of 100 8/11/2016 2:13 P M(f) A current scaled floor plan of all enclosed areas at the registered dispensary that are used in
the business with clear identification of walls, partitions, counters, windows, all areas of ingressand egress, and all limited access areas.
(3) A registrant who files a completed renewal application with the Authority prior to the expiration
date of  the registration may continue to  operate, even after the registration expiration date,pending a decision on the renewal application by the Authority.
(4) A dispensary registrant that does not submit timely renewal documentation in accordance with
sections (1) and (2) of this rule may be subject to the imposition of civil penalties.
(5) If  a dispensary registrant does not submit all the forms, fees and information required in
section (2) of this rule prior to the registration’s expiration, the registration is expired and is nolonger valid.
(6) Renewals will be processed in accordance with OAR 333-008-1040 to  333-008-1060, as
applicable.
(7) A renewal applicant may be required to  submit a Readiness Form, as described in OAR
333-008-1040  and  may  be  subject  to  inspection prior  to  the  Authority  acting  on a  renewal
application.
(8) For purposes of this rule a completed application shall be deemed submitted upon receipt by
the Authority of all application forms, supporting documents and renewal fees described in section(2) of this rule.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450
Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 20-2014, f. & cert. ef.
7-11-14; PH 4-2015, f. & cert. ef. 1-28-15; PH 16-2015(Temp), f. & cert. ef. 9-22-15 thru 3-19-16;PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1075
PRD Criteria and Responsibilities
(1) A PRD must:(a) Be 21 years or age or older;(b) Have legal authority to act on behalf of the dispensary; and(c) Be responsible for ensuring the registered dispensary complies with applicable laws.(2) A PRD may not:
(a) Have been convicted in any state for the manufacture or delivery of a controlled substance in
Schedule I or Schedule II within two years from the date of application; or
(b) Have been convicted more than once in any state for the manufacture or delivery of  a
controlled substance in Schedule I or Schedule II.
(3)  At  least  one  PRD  must  be  on  site  at  a  dispensary  during  Authority  inspections  or
investigations at the time of the inspection or investigation or within one hour of being notified thatan inspection or investigation is taking place.
(4) A PRD is accountable for any intentional or unintentional action of registrant representatives,
with or without the knowledge of the PRD, who violate ORS 475B.450, 475B.453 or these rules,and is responsible for any unlawful conduct that occurs on the premises of the dispensary or anyproperty outside the registered dispensary that is owned by or under the control of the dispensaryregistrant.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1078Removal, Addition, Change, Designation or Assignment of PRD
(1) If  an owner of  a registered dispensary is adding or changing a PRD or primary PRD, an
individual with legal authority to act on behalf of the registered dispensary must submit:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
56 of 100 8/11/2016 2:13 P M(a) A form, prescribed by the Authority;
(b) A legible copy of  the individual’s valid government issued photographic identification that
includes last name, first name and date of birth;
(c) Information and fingerprints required for a criminal background check in accordance with OAR
333-008-2020; and
(d) A criminal background check fee of $35.
(2) A PRD who is designating or assigning the responsibilities of a PRD to another individual
must submit the information and fees required in section (1) of this rule. The responsibilities of aprimary PRD may not be designated or assigned.
(3) The Authority will review and approve the addition or change of a PRD or primary PRD if the
individual meets the requirements in OAR 333-008-1075.
(4) The Authority will review and approve the designation or assignment of the responsibilities of
a PRD to another individual if that individual meets the requirements in OAR 333-008-1075. Anindividual to whom a designation or assignment is made, and who is approved by the Authority,
has the same legal obligations as a PRD.
(5) An individual may not act in the capacity of a PRD without approval from the Authority.(6) If the Authority denies the request to add or change a PRD or primary PRD, or denies the
request to designate or assign the responsibilities of a PRD to another individual, the Authoritymust notify the individual that submitted the request of the denial and the current primary PRD,and describe the reason for the denial.
(7) A registered dispensary may not be open for business or receive or transfer any marijuana
items without at least one Authority approved PRD and a primary PRD.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1110
Locations  of  Medical  Marijuana  Dispensaries;  Dispensary  Premises  Restrictions  and
Requirements
(1) A dispensary may not be located:
(a) In an area that is zoned for residential use.
(b) At the same address as a registered marijuana grow site;(c) Within 1,000 feet of the real property comprising a public or private elementary or secondary
school, except as provided in Oregon Laws 2016, chapter 83, section 29; or
(d) Within 1,000 feet of another medical marijuana dispensary.(2) For purposes of implementing ORS 475B.450(3)(d), the Authority will consider a location to be
a school if it has at least the following characteristics:
(a) Is a public or private elementary or secondary school as those terms are defined OAR
333-008-0010;
(b) There is a building or physical space where students gather together for education purposes
on a regular basis;
(c) A curriculum is provided;(d) Attendance is compulsory under ORS 339.020 or children are being taught as described in
ORS 339.030(1)(a); and
(e) Individuals are present to teach or guide student education.(3) For purposes of determining the distance between a dispensary and a school “within 1,000
feet” means a straight line measurement in a radius extending for 1,000 feet or less in anydirection from the closest point anywhere on the boundary line of the real property comprising anexisting public or private elementary or secondary school to the closest point of the premises of adispensary. If any portion of the premises of a proposed or registered dispensary is within 1,000feet of a public or private elementary or secondary school it may not be registered.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
57 of 100 8/11/2016 2:13 P M(4) For purposes  of  determining the  distance  between a dispensary  and another registered
dispensary “within 1,000 feet” means a straight line measurement in a radius extending for 1,000feet or less in every direction from the closest point anywhere on the premises of a registereddispensary to  the closest point anywhere on the premises of  a proposed dispensary. If  anyportion of the premises of a proposed dispensary is within 1,000 feet of a registered dispensary itmay not be registered.
(5) In order to be registered a dispensary must operate at a particular location as specified in the
application and may not be mobile.
(6) Minors on Premises. A dispensary registrant may not permit a minor to be present in any
limited access or point of sale area of a registered dispensary.
(7) On Premises Consumption.(a) A dispensary registrant may not permit the ingestion, inhalation or topical application of  a
marijuana item anywhere on the premises of the registered dispensary, except as described insubsection (b) of this section.
(b) An employee of  a registered dispensary who is a patient may consume a marijuana item
during his or her work shift on the premises of the registered dispensary as necessary for his orher medical condition, if the employee is:
(A) Alone and in a closed room where no dispensary marijuana items are present;(B) Not visible to patients or caregivers on the premises of the registered dispensary to receive a
transfer of a marijuana item; and
(C) Not visible to the public outside the dispensary.
(c)  For  purposes  of  this  section  consume  does  not  include  smoking,  combusting,  inhaling,
vaporizing, or aerosolizing a marijuana item.
(8) General Public and Visitor Access. The general public is not permitted on the premises of a
registered dispensary, except as permitted by OAR 333-008-1500 and in accordance with thisrule.
(a) In addition to registrant representatives, the following visitors are permitted on the premises of
a dispensary, including limited access areas, subject to the requirements in section (9) of this rule:
(A) Laboratory personnel, if the laboratory is accredited by the Authority;
(B) A contractor authorized by a registrant representative to be on the premises; or(C) Individuals authorized to transfer marijuana items to a registered dispensary.(b) A registered dispensary may permit up to seven invited guests 21 years of age and older, per
week, on the premises of a registered dispensary, including limited access areas, subject to therequirements in section (9) of this rule.
(9) Visitor Escort, Log and Badges.
(a) Prior to entering the premises of a registered dispensary all visitors permitted by section (8) of
this  rule  must  be  documented  and  issued  a  visitor  identification badge  from  a  registrantrepresentative that must remain visible while on the premises. All visitors described in section (8)of this rule must be accompanied by a registrant representative at all times.
(b) A dispensary registrant must maintain a log of all visitor activity and the log must contain the
first and last name and date of birth of every visitor, and the date they visited.
( 1 0 ) G o v e r n m e n t A c c e s s . N o t h i n g i n t h i s r u l e i s i n t e n d e d t o p r e v e n t o r p r o h i b i t A u t h or i t y
employees or contractors, or other state or local government officials that have jurisdiction over
some aspect of the premises or a dispensary registrant to be on the premises.
(a) A visitor badge is not required for government officials.(b) A dispensary must log every government official that enters the premises but the dispensary
may not request that the government official provide a date of birth for the log.
(11) Limited Access Areas.(a) All limited access areas must be physically separated from any area where the general public
is permitted, by a floor to ceiling wall that prevents physical access between a point of sale area
and an area that is open to the general public except through a door that is kept locked by adispensary when the door is not immediately in use.
(b) An applicant or registered dispensary may request, in writing, an exception from the AuthorityOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
58 of 100 8/11/2016 2:13 P Mfrom the requirement to have a floor to ceiling wall. The request must include the reason the
exception is being sought, pictures of the area in question, and a description of an alternativebarrier that accomplishes the goal of providing a significant physical barrier between the generalpublic and any marijuana items on the premises of the dispensary.
(12) A dispensary must have:(a) A designated limited access area or areas where transfers of marijuana items are received
and such an area may not be accessible to patients or designated primary caregivers on the
premises to receive the transfer of a marijuana item or the general public; and
(b) A designated area within the premises where patients and designated primary caregivers and
other visitors enter the dispensary and are checked in.
(13) The areas described in section (12) of this rule must be clearly marked on the floor or plot
plan sketch required in OAR 333-008-1040.
(14) Point of Sale Areas.(a) All point of sale areas must be physically separated from any area where the general public is
permitted by a floor to ceiling wall that prevents physical access between a point of sale area and
an area that is  open to  the general public  except through a door that is  kept locked by adispensary when the door is not immediately in use.
(b) All areas where marijuana items are available for transfer to a patient or designated primary
caregiver must be supervised by a dispensary representative at all times when a patient ordesignated primary caregiver is present.
(c) A dispensary may not transfer a marijuana item to a patient or designated primary caregiver
through a drive-through window.
(15) A dispensary may not sublet or share with any other business any portion of the dispensary
premises.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 20-2014, f. & cert. ef.
7-11-14; PH 4-2015, f. & cert. ef. 1-28-15; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f.
6-24-16, cert. ef. 6-28-16
333-008-1190Testing
(1) This rule is in effect until October 1, 2016.
(a) Nothing in this rule prohibits a dispensary or an accredited laboratory from complying with the
testing rules in OAR 333-007-0300 to 333-007-0490 and providing or accepting a test result thatis in compliance with OAR 333-064-0100 and 333-064-0110 in lieu of a test result required in thisrule.
(b) Nothing in this rule prohibits an accredited laboratory from performing sampling and testing for
a registrant in accordance with this rule, prior to October 1, 2016.
(2) For purposes of this rule:
(a) “Batch” has the same meaning given that term in OAR 333-007-0310.(b) “TNI” has the same meaning given that term in OAR 333-007-0310.(c) “TNI standards” has the same meaning given that term in OAR 333-007-0310.(3)  Prior  to  being  registered  a  PRD  must  have  documentation that  identifies  at  least  one
laboratory that will do the testing in accordance with this rule.
(4) A registered dispensary may only accept laboratory test results from a laboratory on the
Authority’s list posted on the Authority’s website, www.healthoregon.org/ommp.
(5) A PRD must have a test report that complies with section (11) of this rule that can be linked to
the batch from which each sample was taken and to each marijuana item available for transfer,before the marijuana item is available for transfer to a patient or a designated primary caregiver.
(6) A registered dispensary may submit samples for testing in accordance with section (7) of this
rule or a PRD may accept test results if:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
59 of 100 8/11/2016 2:13 P M(a) A copy of the test results is obtained at the time of transfer that clearly links the test results to
the marijuana item being transferred;
(b) The PRD can demonstrate to the Authority that random samples from the batch were taken
and submitted for testing; and
(c) The PRD can demonstrate to the Authority that the batch from where samples were taken was
sealed and not tampered with from the time samples for testing were taken and when they weredelivered to the dispensary.
(7) Prior to October 1, 2016, if a dispensary accepts the transfer of a marijuana item that has not
been tested in accordance with this rule a dispensary representative must:
(a) Segregate each untested batch and place the batch in an individual container or bag with a
label attached to the container or bag that includes at least the following information:
(A) A unique identifier;(B) The name of the product;(C) The name of the person who transferred the marijuana item;
(D) The date the marijuana item was received; and
(E) “PRODUCT NOT TESTED” in bold, capital letters, no smaller than 12 point font.(b) Take random samples from each batch in an amount necessary to conduct the applicable test,
label each sample with the batch’s unique identifier, and submit the samples for testing.
(c) Once samples have been taken for the purpose of testing, store and secure the untested item
in a manner that prevents the item from being tampered with or transferred prior to test results
being reported.
(8) Pesticide Testing. A marijuana item, except for seeds and immature plants, must be tested for
pesticides by testing for individual pesticides (analytes) in the following categories, using validtesting methodologies:
(a) Chlorinated Hydrocarbons;(b) Organophosphates;(c) Carbamates; and
(d) Pyrethroid.
(9) THC and CBD Testing. A marijuana item, except for seeds and immature plants, must be
tested to determine the levels of THC and CBD using valid testing methodologies.
(10) Laboratory Requirements. A PRD must be able to show that the laboratory that conducted
the testing required in this rule:
(a) Uses valid testing methodologies; and(b) Has a Quality System for testing of pesticides that is compliant with the:
(A) 2005 International Organization for Standardization 17025 Standard; or
(B) 2009 National Environmental Laboratory Accreditation Conference Institute TNI Standards.(11) Testing Results. A laboratory test result must:(a) Comply with the standards in TNI 2009, Volume 1, Module 2, Section 5.10, incorporated by
reference.
(b) Include the following information:
(A) The name of each specific analyte tested;
(B) The limit of quantitation (LOQ) as that is defined in TNI 2009, Volume 1, Module 2, Section
3.1 and TNI 2009, Volume 1, Module 4, Section 1.5, incorporated by reference;
(C) The pesticide results as a numerical value in units of either parts per million or parts per billion
if the analyte was detected or a statement that the level detected was less than the LOQ;
(D) The levels of THC and CBD calculated in accordance with OAR 333-064-0100; and(E) The quality control results from the blank and quality control samples associated with the
sample testing.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
60 of 100 8/11/2016 2:13 P M(c) Be signed by an official of the laboratory with an attestation that the results are accurate and
that testing was done using valid testing methodologies and a quality system as required in thisrule.
(12) A sample of a marijuana item shall be deemed to test positive for pesticides with a detection
of more than 0.1 parts per million of any pesticide.
(13) If a marijuana item tests positive for pesticides based on the standards in this rule the PRD
must:
(a) Return the entire batch from which the sample was taken to the individual who transferred the
marijuana item to the dispensary and document how many or how much was returned, to whom,and the date it was returned; or
(b) Dispose of the entire batch in a manner specified by the Authority.(14) The PRD may permit laboratory personnel or other persons authorized to do testing access
to  secure or restricted access areas of  the dispensary where marijuana items are stored. Adispensary representative must log the date and time in and out of all such persons.
(15) If the Authority determines that a laboratory is not using valid testing methodologies, does
not have a quality system, or is not producing test result reports in accordance with this rule theAuthority may remove the name of the laboratory from the list on the Authority’s website.
(16) The Authority may do  audit testing of  a marijuana item in order to  determine whether a
dispensary is in compliance with this rule.
[ED. NOTE: Appendix referenced are available from the agency.]Stat. Auth.: ORS 475B.450 & 475B.525
Stats. Implemented: ORS 475B.450
Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 8-2014(Temp), f. 2-19-14,
cert. ef. 2-21-13 thru 7-13-14; PH 20-2014, f. &  cert. ef. 7-11-14; PH 4-2015, f. &  cert. ef.1-28-15; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1200
Operation of Registered Dispensaries
(1)  Policies  and  Procedures.  In order  to  obtain a  registration and  to  retain registration a
dispensary  registrant  must  have  written  detailed  policies  and  procedures  and  training  foremployees on the policies and procedures that, at a minimum, cover the following:
(a) Security;
(b) Transfers of marijuana items to and from the dispensary;
(c) Operation of a registered dispensary;(d) Required record keeping;(e) Testing requirements;(f) Packaging and labeling requirements;(g) Employee training;
(h) Compliance with these rules, including but not limited to violations and enforcement; and
(i)  Roles  and  responsibilities  for  employees  and  PRDs  in  assisting  the  Authority  during
inspections or investigations..
(2) Employees. A registered dispensary may employ an individual between the ages of 18 and 20
if the individual is a patient. Otherwise, dispensary employees must be 21 years of age or older.
(3) Standardized Scales. In order to obtain a registration and to retain registration a dispensary
registrant must own, maintain on the premises and use a weighing device that is licensed by the
Oregon Department of  Agriculture. Licensed weighing devices must be used by a registered
dispensary whenever marijuana items are:
(a) Transferred to or from the dispensary and the transfer is by weight;(b) Packaged for transfer by weight; or(c)  Weighed  for  purposes  of  documenting  information  required  in  OAR  333-008-1230,Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
61 of 100 8/11/2016 2:13 P M333-008-1245, 333-008-1247 and 333-008-1248.
(4) Inventory Tracking and Point of Sale System: In order to obtain a registration and to retain
registration a  registered  dispensary  must  have  an installed  and  fully  operational integratedinventory tracking and point of sale system that can and does, at a minimum:
(a) Produce  bar codes  or similar unique  identification numbers  for each marijuana  item lot
transferred to a registered dispensary;
(b) Trace back or link each transfer of a marijuana item to a patient or caregiver to the marijuana
item lot;
(c) Capture all information electronically that is required to be documented in OAR 333-008-1230
and 333-008-1245;
(d) Generate inventory, transaction, and transfer reports viewable in excel format; and(e) Produce all the  information required  to  be  submitted to  the  Authority  pursuant to  OAR
333-0080-1248.
(5) Online Verification of Registration Status. A dispensary must verify an individual’s registration
status with the Authority when receiving or making the transfer of a marijuana item if the Authority
has available an online system for such verification.
(6) Inventory On-Site. Marijuana items must be kept on-site at the dispensary. The Authority may
take enforcement action against a dispensary registrant if  during an inspection a dispensaryregistrant cannot account for its inventory or if  the amount of  usable marijuana at the registereddispensary is not within five percent of the documented inventory.
(7) Testing. On and after October 1, 2016, a dispensary registrant may not:
(a) Accept a transfer of  a marijuana item that has not been tested in accordance with OAR
333-007-0300 to 333-007-0490.
(b) Transfer a marijuana item that has not been tested in accordance with OAR 333-007-0300 to
333-007-0490 unless it is labeled in accordance with OAR 333-007-0300.
(8) Packaging and Labeling. On and after October 1, 2016, a dispensary may not accept a
transfer of a marijuana item or transfer a marijuana item that does not comply with the labelingrequirements in OAR 333-007-0010 to 333-007-0100, or that does not comply with the packaging
requirements in OAR 845-025-7000 to 845-025-7020 and 845-025-7060.
(9) Oregon Department of  Agriculture Licensure. On and after October 1, 2016, a registered
dispensary that sells or handles food, as that term is defined in ORS 616.695, or cannabinoidedibles, must be licensed by the Oregon Department of Agriculture under ORS 616.706.
(10) Industrial Hemp Products.(a) A dispensary may only accept the transfer of and may only transfer a product that contains
THC or CBD that is derived from marijuana.
(b) Nothing in this section prohibits a dispensary from buying or selling hemp products not
intended for human application, consumption, inhalation, ingestion, or absorption, such as hempclothing.
(11) Tobacco. A dispensary may not offer or sell tobacco products in any form including, but not
limited to, loose tobacco, pipe tobacco, cigarettes as defined in ORS 323.010 and cigarillos asthat is defined in OAR 333-015-0030.
(12) For purposes of this rule “marijuana item lot” means a quantity of seeds, immature plants,
usable  marijuana,  medical  cannabinoid  products,  concentrates  or  extracts  transferred  to  a
registered dispensary at one time and that is from the same harvest lot or process lot as thoseterms are defined in OAR 333-007-0020.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 20-2014, f. & cert. ef.
7-11-14; PH 4-2015, f. & cert. ef. 1-28-15; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f.6-24-16, cert. ef. 6-28-16
333-008-1205
Registered Dispensary Signage
(1) In order to obtain a registration and to retain registration a dispensary registrant must post:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
62 of 100 8/11/2016 2:13 P M(a) At every entrance to the dispensary:
(A) If a dispensary does not participate in limited marijuana retail sales a sign that reads “Medical
Marijuana Patients Only”;
(B) If a dispensary is permitted to sell limited marijuana retail products in accordance with OAR
333-008-1500, signs that comply with OAR 333-008-1500 and 333-008-1501(1)(b); and
(C) “No On-Site Consumption of Marijuana”.
(b) At all areas of ingress to a limited access area signs that reads:
(A) “Restricted Access Area — Authorized Personnel Only”.(B) “No Minors Allowed”.(c) At all areas of ingress to a point of sale area a sign that reads: “Restricted Access Area — No
Minors Allowed”.
(d) At the point of sale, the following posters prescribed by the Authority, measuring 22 inches
high by 17 inches wide that can be downloaded at www.healthoregon.org/ommp:
(A) A Pregnancy Warning Poster; and
(B) A Poisoning Prevention Poster.(2) All signs required by this rule must be:(a) Legible, not less than 8 1/2 inches by and 11 inches, composed of  letters not less than
one-half inch in height;
(b) In English and Spanish, if a Spanish version is available through the Authority; and(c) Posted in a conspicuous location where the signs can be easily read by individuals entering or
on the dispensary premises.
(3) All signs may be downloaded at www.healthoregon.org/ommp.Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1225
Packaging
(1) This rule is in effect from March 1, 2016 until October 1, 2016. Nothing in this rule prohibits a
dispensary from complying with the packaging rules in OAR 845-025-7000 to 845-025-7060 prior
to October 1, 2016.
(2) For purposes of this rule:(a) “Child-resistant safety packaging” means:(A) Containers designed and constructed to be significantly difficult for children under five years
of age to open and not difficult for adults to use properly;
(B) Closable for any product intended for more than a single use or containing multiple servings;
and
(C) Labeled in accordance with OAR 333-008-1220.
(b) “Container” means a sealed, hard or soft-bodied receptacle in which a tetrahydrocannabinol-
infused product is placed prior to being transferred to a patient or caregiver.
(c) “Packaged in a manner not  attractive to  minors” means  the tetrahydrocannabinol-infused
product is not in a container that is brightly colored, depicts cartoons or images other than thelogo of the facility, unless the logo of the facility depicts cartoons, in which case only the name ofthe facility is permitted.
(3) A dispensary may not transfer a medical cannabinoid product, extract or concentrate to a
patient  or  caregiver  unless  the  product,  extract  or  concentrate  is  in  child-resistant  safetypackaging.
Stat. Auth.: ORS 475B.450 & 475B.525Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
63 of 100 8/11/2016 2:13 P MStats. Implemented: ORS 475B.450
Hist.: PH 9-2014(Temp), f. & cert. ef. 4-1-14 thru 9-27-14; PH 25-2014, f. & cert. ef. 9-24-14; PH
4-2015, f. & cert. ef. 1-28-15; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 13-2016(Temp), f.4-13-16, cert. ef. 4-15-16 thru 9-30-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1230
Transfers to a Registered Dispensary
(1) Transfer of Usable Marijuana, Seeds and Immature Plants. A patient, caregiver, or PRMG
may transfer usable marijuana, seeds and immature plants produced by a PRMG to a registereddispensary, subject to the requirements in this rule.
(a) A registered dispensary may only accept a transfer of usable marijuana, seeds or immature
marijuana plants from a caregiver or PRMG if  the individual transferring the usable marijuana,
seeds or immature plants provides the original or a copy of a valid:
(A) Authorization to Transfer form prescribed by the Authority; or(B) Personal agreement as that is defined in OAR 333-008-0010.(b) Authorization to Transfer Forms. In order to be valid an Authorization to Transfer form must
include at least:
(A) The patient’s name, OMMP card number or receipt number and expiration date and contact
information;
(B) The name and contact information of the individual who is authorized to transfer the usable
marijuana, seeds or immature marijuana plants to the registered dispensary and that individual’sOMMP card number and expiration date;
(C) The name and address of the registered dispensary that is authorized to receive the usable
marijuana, seeds or immature marijuana plants; and
(D) The date the authorization expires, if earlier than the expiration date of the patient’s OMMP
card.
(c) Personal Agreements. In order to be valid a personal agreement must include at least:(A) The patient’s name, OMMP card number and expiration date and contact information;(B) The name and contact information of the PRMG to whom the patient’s property rights have
been assigned and the producer’s OMMP card number and expiration date, and the grow siteaddress;
(C) The portion of the patient’s rights to possess seeds, immature plants and usable marijuana
that is being assigned to the producer.
(2) Transfer of medical cannabinoid products, concentrates, and extracts.(a) Until October 1, 2016, a registered dispensary may accept the transfer of  a cannabinoid
product or concentrate from a patient, caregiver or PRMG in accordance with section (1) of thisrule.
(b) On and after October 1, 2016, a registered dispensary may only accept a transfer of a medical
cannabinoid product, concentrate or extract from a registered medical marijuana processing site.
(c)  Until  October  1,  2016,  a  registered  dispensary  may  accept  the  transfer  of  a  medical
cannabinoid extract from a marijuana processing site.
(3) A registered dispensary may only accept a transfer of cannabinoid products, concentrates or
extracts from registered processing site if the individual transferring the products, concentrates orextracts provides the dispensary with a Processing Site Authorization to Transfer form prescribedby the Authority. In addition to retaining a copy of the Processing Site Authorization to Transferform the dispensary must obtain a copy of the photo identification of the individual transferring the
cannabinoid product, concentrate or extract as required in section (4)(b)(B) of this rule.
(4) Transfer Records. At the time a marijuana item is transferred to a dispensary the dispensary
registrant must:
(a) Document, as applicable:(A) The weight in metric units of all usable marijuana received by the registered dispensary;(B) The number of seeds and immature plants received by the registered dispensary;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
64 of 100 8/11/2016 2:13 P M(C) The  amount  of  a  medical cannabinoid  product,  concentrate,  or extract  received  by  the
registered dispensary, including, as applicable, the weight in metric units, or the number of units;
(D) The name of the marijuana item;(E) The date the marijuana item was received; and(F) The amount of reimbursement paid by the registered dispensary.(b) Obtain and maintain a copy of, as applicable:
(A) Documents required in section (1) of this rule including the date it was received;
(B) The photo identification of the individual transferring the marijuana item to the dispensary, if
such a copy is not already on file;
(C) The OMMP card of the individual transferring usable marijuana, seeds or immature plants;(D) The medical marijuana processing site registration; and(E) Test results for marijuana items transferred to the dispensary unless the dispensary plans to
arrange for the testing of the marijuana item.
(5) Prior to October 1, 2016, if a dispensary accepts the transfer of a marijuana item that has not
been tested in accordance with OAR 333-007-0300 to 333-007-0490 the dispensary must complywith OAR 333-008-1190(7).
(6)  Once  a  marijuana  item  has  been sampled  in accordance  with OAR  333-007-0360  the
marijuana item must be labeled and stored in accordance with OAR 333-007-0380.
(7) Nothing in these rules requires a dispensary registrant to accept a transfer of a marijuana item.(8) All documentation required in this  rule must be maintained electronically in an integrated
inventory tracking and point of sale system or the electronic data man agement system described
in OAR 333-008-1247.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14; PH 20-2014, f. & cert. ef.
7-11-14; PH 4-2015, f. & cert. ef. 1-28-15; PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f.6-24-16, cert. ef. 6-28-16
333-008-1245
Transfers From a Registered Dispensary to a Patient or Designated Primary Caregiver
(1) A dispensary registrant must, prior to permitting an individual to enter a point of sale area on
the dispensary premises, except as permitted under OAR 333-008-1500, verify that the individual
is a current patient or designated primary caregiver.
(2)  A  registered  dispensary  must,  prior  to  transferring  a  marijuana  item  to  a  patient  or  a
designated primary caregiver:
(a)  Verify  the  individual is  currently  registered  with the  Authority  by  viewing  the  individual’s
government issued photo  identification and Authority issued patient or caregiver card, or thepatient’s receipt, as described in OAR 333-008-0023(6) or OAR 333-008-0040(5) and making
sure the identities match.
(b) Obtain and retain, if not already on file, a copy of the patient’s or caregiver’s:(A) OMMP identification card or receipt; and(B) Government issued photo identification.(c) Document:(A) The name, OMMP card number and expiration date of the card of each person to whom the
registered facility transfers a marijuana item;
(B) If the marijuana item was transferred to a designated primary caregiver, the patient’s name
and registration number for whom the caregiver was receiving the transfer;
(C) The amount of usable marijuana transferred in metric units, if applicable;(D) The number of seeds or immature plants transferred, if applicable;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
65 of 100 8/11/2016 2:13 P M(E) The amount of a medical cannabinoid product concentrate, or extract, if applicable;
(F) The brand name of the marijuana item and a description of what was transferred;(G) The date of the transfer; and(H) The amount of money paid by the patient or designated primary caregiver for the transfer.(3) A dispensary registrant may not transfer at any one time to a patient or designated primary
caregiver, within one day, more than:
(a) 24 ounces of usable marijuana;
(b) 16 ounces of a medical cannabinoid product in solid form;(c) 72 ounces of a medical cannabinoid product in liquid form;(d) 16 ounces of a cannabinoid concentrate whether sold alone or contained in an inhalant delivery
system;
(e) Five grams of a cannabinoid extract whether sold alone or contained in an inhalant delivery
system;
(f) Four immature marijuana plants; and
(g) 50 seeds.(4) All documentation required in this  rule must be maintained electronically in an integrated
inventory tracking and point of sale system or the electronic data man agement system described
in OAR 333-008-1247.
Stat. Auth.: ORS 475B.450 & 475B.525Stats. Implemented: ORS 475B.450
Hist.: PH 9-2014(Temp), f. & cert. ef. 4-1-14 thru 9-27-14; PH 25-2014, f. & cert. ef. 9-24-14; PH
9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1610
Definitions
For purposes of OAR 333-008-1600 to 333-008-2200:(1) “Cannabinoid capsule” means a small soluble container, usually made of gelatin, that encloses
a dose of a cannabinoid product, concentrate or extract intended for human ingestion.
(2) “Cannabinoid edible” means a food or potable liquid into which a cannabinoid concentrate or
extract or the dried leaves or flowers of marijuana have been incorporated.
(3)  “Cannabinoid  suppository”  means  a  small  soluble  container  designed  to  melt  at  body
temperature within a body cavity other than the mouth, especially the rectum or vagina, containinga cannabinoid product, concentrate or extract.
(4) “Cannabinoid tincture” means a solution of  alcohol, cannabinoid concentrate or extract, and
perhaps other ingredients intended for human consumption or ingestion, and that is exempt fromthe Liquor Control Act under ORS 471.035.
(5) “Cannabinoid topical” means a cannabinoid product intended to be applied to skin or hair.(6) “Cannabinoid transdermal patch” means an adhesive substance applied to human skin that
contains a cannabinoid product, concentrate or extract for absorption into the bloodstream.
(7) “Food” means a raw, cooked, or processed edible substance, beverage or ingredient used or
intended for use or for sale in whole or in part for human consumption, or chewing gum.
(8) “Person responsible for the marijuana processing site” or “PRP” means an individual who is
directly involved in the day-to-day operation of a processing site and is identified as a PRP on anapplication.
(9) “Primary PRP” means a PRP designated by the owner of the processing site as the primary
point of contact for the Authority and who is authorized to receive any and all communications
and legal notices from the Authority.
(10) “Processing site representative” means an owner, director, officer, PRP, manager, employee,
agent or other representative of a registered processing site, to the extent that the person acts ina representative capacity.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
66 of 100 8/11/2016 2:13 P M(11) “Processing site registrant” means:
(a) An individual who owns a registered processing site or if a business entity owns the registered
processing site, each individual who has a financial interest in the registered processing site; and
(b) Any PRP.(12) “These rules” means OAR 333-008-1600 to 333-008-2200.Stat. Auth.: ORS 475B.435
Stats. Implemented: ORS 475B.435
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1620
Application for Medical Marijuana Processing Site Registration
(1) This rule applies to any initial application filed on or after June 24, 2016 and to any initial
application filed prior to June 24, 2016 that the Authority has not yet approved or denied.
(2) To register a medical marijuana processing site a person must:(a) Submit an initial application on a form prescribed by the Authority that includes but is not
limited to:
(A) The name of the individual who owns the processing site or, if a business entity owns the
processing site, the name of each individual who has a financial interest in the processing site;
(B) The name of the individual or individuals responsible for the processing site, if different from
the name of the individual who owns the processing site, with one of the individuals responsiblefor the processing site identified as the primary PRP;
(C) The address of the marijuana processing site; and(b) Application and registration fees.(c) An initial application for the registration of a processing site must be submitted electronically
via the Authority’s website, www.healthoregon.org/ommp.
(3) If an initial application is submitted along with the required fees the Authority will notify the
applicant  that  the initial application has  been received and that  within 30 calendar days  thefollowing information must be received by the Authority:
(a) For each individual named in the application:(A) A legible copy of  the individual’s valid government issued photographic identification that
includes last name, first name and date of birth;
(B) Information, fingerprints and fees required for a criminal background check in accordance with
OAR 333-008-2020; and
(C) An Individual History Form and any information identified in the form that is required to be
submitted.
(b) If the applicant intends to process extracts, proof from the local government that the proposed
location of the processing site is not located in an area that is zoned for residential use;
(c) Proof that the business is registered or has filed an application to register as a business with
the Oregon Office of the Secretary of State, including proof of registration of any DBA (doing
business as) registration;
(d) A scaled site plan of the parcel or premises on which the premises proposed for registration,
is located, including:
(A) Cardinal directional references;(B) Bordering streets and the names of the streets;(C) Identification of  the building or buildings in which the proposed processing site is to  be
located;
(D) The dimensions of the proposed premises of the processing site;(E) Identification of other buildings or property owned by or under the control of the applicant on
the same parcel or tax lot as the premises proposed for registration that will be used in theOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
67 of 100 8/11/2016 2:13 P Mbusiness; and
(F) Identification of any residences on the parcel or tax lot;.(e) A scaled floor plan of all enclosed areas of the premises at the proposed location that will be
used in the business with clear identification of walls, partitions, counters, windows, all areas ofingress and egress, intended uses of all spaces;
(f) Documentation that shows the applicant has lawful possession of the proposed location of the
processing site;
(g) A description of the type of products to be processed, a description of equipment to be used,
including  any  solvents,  gases,  chemicals  or  other  compounds  used  to  create  extracts  orconcentrates on a form prescribed by the Authority; and
(h) The proposed endorsements as described in OAR 333-008-1700.(4) The information and documentation required in section (3) of  this rule may be submitted
electronically to  the Authority or may  be mailed to  the Oregon Medical Marijuana Program,Oregon Health Authority, PO Box 14116, Portland, OR 97293.
(a) If documentation is mailed, it must be received by the Authority within 30 calendar days of the
date the Authority mailed the notice to  the applicant that the application was received or theapplication will be considered incomplete.
(b) If documentation is submitted electronically it must be received by the Authority within 30
calendar days of the date the Authority mailed the notice to the applicant that the application wasreceived or the application will be considered incomplete.
(5) Application and registration fees must be paid online at the time of application.
(6) Criminal background check fees must be paid by check or money order and must be mailed to
the Oregon Medical Marijuana Program, Oregon Health Authority, PO Box 14116, Portland, OR97293 and must be received by the Authority in accordance with provisions in section (4) of thisrule.
(7) If the Authority does not receive a complete application, all documentation required in sections
(2) and (3) of this rule, and all required fees within the time frames established in this rule, theapplication will be considered incomplete.
(8) If the applicant provides the documentation required in section (3) of this rule, the Authority will
review the information to determine if it is complete.
(a) If the documentation is not complete or is insufficient the Authority must notify the applicant in
writing and the applicant will have 10 calendar days from the date such written notice is mailed bythe Authority to provide the additional documentation.
(b) If the applicant does not provide the additional documentation within 10 calendar days or if any
responsive documents are incomplete, insufficient or otherwise do not demonstrate compliance
with ORS 475B.450 and these rules the application will be declared incomplete.
(9) A person who wishes to register more than one location must submit a separate application,
registration fees, and all documentation described in sections (2) and (3) of this rule for eachlocation.
(10) An application that is incomplete is treated by the Authority as if it was never received.Stat. Auth.: ORS 475B.435Stats. Implemented: ORS 475B.435
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1650Processing Site Application Review
(1) Applications will be reviewed in the order they are received by the Authority. An application is
considered received as of the date and time that payment of fees is authorized by the entity thatissued the credit or debit card used to pay the fees.
(2) Once the Authority has determined that an application is complete it will review an application
to the extent necessary to determine compliance with ORS 475B.435 and these rules.
(3) The Authority may, in its discretion, prior to acting on an application:(a) Contact  any  individual listed on the application and request  additional documentation orOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
68 of 100 8/11/2016 2:13 P Minformation;
(b) Inspect the premises of the proposed processing site; or(c) Verify any information submitted by the applicant.(4) Prior to making a decision whether to approve or deny an application the Authority must:(a) Review the criminal background check results for each individual named on the application;(b) Verify that the applicant is registered as a business with the Office of the Secretary of State;
and
(c) Verify that the proposed location of the processing site is not located:(A) In an area that is zoned for residential use if the processor intends to make extracts; and(B) Is not in a city or county that has adopted an ordinance under ORS 475B.800 or section 133,
chapter 614, Oregon Laws 2015, prohibiting processing sites.
(5) If  during  the  review process  the  Authority  determines  that  the  application or  supporting
documentation contains intentionally false or misleading information the Authority may declare the
application incomplete or deny the application in accordance with OAR 333-008-1670.
(6) The Authority will notify the applicant in writing that the applicant has 60 calendar days from the
date of the written notice to submit a Readiness Form, prescribed by the Authority, indicating thatthe applicant is prepared for an inspection and is in compliance with these rules if:
(a) There is no basis for denial under OAR 333-008-1670;(b) The proposed processing site is in compliance with ORS 475B.435 and these rules;(c) Each individual named in the application passes the criminal background check; and
(d) Each individual named as a PRP in the application meets the age requirement.
(7) If the Authority does not receive the Readiness Form in accordance with section (6) of this rule
the applicant’s application will be declared incomplete, unless an extension has been grantedunder section (8) of this rule.
(8) An applicant may request one extension of the 60-day deadline in section (6) of this rule if the
applicant can demonstrate to the Authority that the deadline cannot be met for reasons outside ofthe  applicant’s  control,  such  as  but  not  limited  to  the  applicant’s  inability  to  obtain  local
government building permits.
(a) A request for an extension must be in writing, must be received within 60 calendar days of the
notice described in section (6) of  this rule, and must explain and provide documentation thatshows the applicant cannot, for reasons  outside of  the applicant’s control, meet the 60-daydeadline.
(b) A request for an extension tolls the 60-day deadline.(c) The Authority will review the request and provide, in writing to the applicant, its decision and
the reason for the decision.
(d) If  an extension is granted the Authority must inform the applicant of  the new deadline for
submission of the Readiness Form, but in any case an extension may not exceed 60 calendardays.
Stat. Auth.: ORS 475B.435Stats. Implemented: ORS 475B.435Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1670
Denial of Processing Site Application
(1) The Authority must deny an application for the registration of a processing site if:
(a) An application, supporting documentation provided by the applicant, or other information
obtained by the Authority shows that the qualifications for a processing site in ORS 475B.435 orthese rules have not been met; or
(b) An individual named in an application has been:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
69 of 100 8/11/2016 2:13 P M(A) Convicted for the manufacture or delivery of a controlled substance in Schedule I or Schedule
II within two years from the date the application was received by the Authority; or
(B) Convicted more than once for the manufacture or delivery  of  a controlled substance in
Schedule I or Schedule II; or
(c) The city or county in which the facility is located has prohibited processing sites in accordance
with ORS 475B.800 or section 133, chapter 614, Oregon Laws 2015.
(2) The Authority may deny an applicant if  it determines that the applicant, the owner of  the
processing site, a PRP, or an employee of the processing site:
(a) Submitted false or misleading information to the Authority; or(b) Violated a provision of  ORS 475B.400 to 475.525, 475B.555, 475B.605, 475B.615, OAR
chapter 333, division 7, these rules or an ordinance adopted pursuant to ORS 475B.500.
(3)  If  an individual named  in an application is  not  qualified  based  on age,  or  the  criminal
background check, the Authority will permit a change form to be submitted in accordance withOAR 333-008-1720 or 333-008-2030, along with the applicable criminal background check fee. If
the individual named in the change form is not qualified the Authority must deny the application in
accordance with section (1) of this rule.
(4) If  the Authority intends to  deny an application for registration it must issue a Notice of
Proposed Denial in accordance with ORS 183.411 through 183.470.
Stat. Auth.: ORS 475B.435Stats. Implemented: ORS 475B.435Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1690
Expiration and Renewal of Registration for Processing Site
(1) A processing site’s registration expires one year following the date of application approval.
(2) A processing site registrant must submit not more than 90 but at least 30 calendar days before
the registration expires:
(a) A renewal application on a form prescribed by the Authority;(b) Renewal fees;(c) For each individual named in the renewal application:(A) A legible copy of  the individual’s valid government issued photographic identification that
includes last name, first name and date of birth;
(B) Information, fingerprints and fees required for a criminal background check in accordance with
OAR 333-008-2020; and
(C) An Individual History Form and any information identified in the form that is required to be
submitted.
(d) Current proof of business registration with the Secretary of State, including all DBA (doing
business as) registrations;
(e) Documentation that shows the applicant has lawful possession of the location of the registered
processing site; and
(f) A current scaled floor plan of all enclosed areas at the proposed location that will be used in the
business with clear identification of walls, partitions, counters, windows, all areas of ingress andegress, uses of all spaces and all limited access areas.
(3) A registrant who files a completed renewal application, fees, and all the information required in
section (2) of  this rule with the Authority prior to  the expiration date of  the registration may
continue to operate, even after the registration expiration date, pending a decision on the renewal
application by the Authority.
(4) A  processing  site  registrant  that  does  not  submit  a  timely  application,  fees  and  all the
information required in section (2) of this rule may be subject to the imposition of civil penalties.
(5) If  a processing site registrant does  not submit  the renewal application, fees  and all the
information required in section (2) of this rule prior to the registration’s expiration, the registrationis expired and is no longer valid.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
70 of 100 8/11/2016 2:13 P M(6) Renewals will be processed in accordance with OAR 333-008-1650 to  333-008-1670, as
applicable.
(7) A renewal applicant may be required to  submit a Readiness Form, as described in OAR
333-008-1650(9) and may be subject to  inspection prior to  the Authority acting on a renewalapplication.
Stat. Auth.: ORS 475B.435Stats. Implemented: ORS 475B.435
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1710PRP Criteria and Responsibilities
(1) A PRP must:
(a) Be 21 years or age or older;(b) Have legal authority to act on behalf of the registered processing site; and(c) Be responsible for ensuring the registered processing site complies with applicable laws.(2) A PRP may not:(a) Have been convicted in any state for the manufacture or delivery of a controlled substance in
Schedule I or Schedule II within two years from the date of application; or
(b) Have been convicted more than once in any state for the manufacture or delivery of  a
controlled substance in Schedule I or Schedule II.
(3) At  least  one PRP  must  be on site at  a processing site during Authority  inspections  or
investigations at the time of the inspection or investigation or within one hour of being notified thatan inspection or investigation is taking place.
(4)  A  PRP  is  accountable  for  any  intentional  or  unintentional  action  of  a  processing  site
representative,  with or  without  the  knowledge  of  the  PRP,  who  violates  ORS  475B.435  to
475B.440 or these rules, and is responsible for any unlawful conduct that occurs on the premisesof the processing site or any property outside the registered processing site that is owned by orunder the control of the processing site registrant.
Stat. Auth.: ORS 475B.435Stats. Implemented: ORS 475B.435Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1720
Removal, Addition, Change, Designation or Assignment of PRP
(1) If an owner of a registered processing site is adding or changing a PRP or primary PRP, an
individual with legal authority to act on behalf of the registered processing site must submit:
(a) A form, prescribed by the Authority;(b) A legible copy of  the individual’s valid government issued photographic identification that
includes last name, first name and date of birth;
(c) Information and fingerprints required for a criminal background check in accordance with OAR
333-008-2020; and
(d) A criminal background check fee of $35.
(2) A PRP who is designating or assigning the responsibilities of a PRP to another individual must
submit the information and fees required in section (1) of this rule. The duties of a primary PRPmay not be designated or assigned.
(3) The Authority will review and approve the addition or change of a PRP or primary PRP if the
individual meets the requirements in OAR 333-008-1710.
(4) The Authority will review and approve the designation or assignment of the responsibilities of
a PRP to another individual if that individual meets the requirements in OAR 333-008-1710. An
individual to whom a designation or assignment is made, and who is approved by the Authority,
has the same legal obligations as a PRP.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
71 of 100 8/11/2016 2:13 P M(5) An individual may not act in the capacity of a PRP without approval from the Authority.
(6) If the Authority denies the request to add or change a PRP or primary PRP, or denies the
request to designate or assign the responsibilities of a PRP to another individual, the Authoritymust notify the individual that submitted the request of the denial and the current primary PRP anddescribe the reason for the denial.
(7) A registered processing site may not process marijuana or receive or transfer any marijuana
items without at least one Authority approved PRP and a primary PRP.
Stat. Auth.: ORS 475B.435
Stats. Implemented: ORS 475B.435Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1730
Registered Processing Site Premises Restrictions and Requirements
(1) A registered processing site may not be located in an area that is zoned for residential use if
the processing site is endorsed to make cannabinoid extracts.
(2) In order to be registered a processing site must operate at a particular location as specified in
the application and may not be mobile.
(3) Minors on Premises. A registered processing site may not permit a minor to be present in any
limited access area of a registered processing site.
(4) On Premises Consumption.(a) A registered processing site may not permit the ingestion, inhalation or topical application of a
marijuana  item  anywhere  on the  premises  of  the  processing  site,  except  as  described  insubsection (b) of this section.
(b) An employee of a registered processing site who is a patient may consume a marijuana item
during his or her work shift on the premises of the registered processing site as necessary for his
or her medical condition, if the employee is:
(A) Alone and in a closed room where no processing site marijuana items are present; and(B) Not visible to the public outside the registered processing site.(c)  For  purposes  of  this  section  consume  does  not  include  smoking,  combusting,  inhaling,
vaporizing, or aerosolizing a marijuana item.
(5) General Public and Visitor Access. The general public is not permitted on the premises of
registered processing site, except as permitted by this rule.
(a) In addition to registrant representatives, the following visitors are permitted on the premises of
a processing site, including limited access areas, subject to the requirements in section (6) of thisrule:
(A) Laboratory personnel, if the laboratory is accredited by the Authority;(B) A contractor authorized by a registrant representative to be on the premises; or(C) Individuals authorized to transfer marijuana items to a registered processing site.
(b) A registered processing site may permit up to seven invited guests 21 years of age and older,
per week, on the premises of a registered processing site, including limited access areas, subjectto the requirements in section (6) of this rule.
(6) Visitor Escort, Log and Badges.(a) Prior to entering the premises of a registered processing site all visitors permitted by section
(5) of this rule must be documented and issued a visitor identification badge from a registrantrepresentative that must remain visible while on the premises. A visitor badge is not required for
government officials. All visitors described in section (5) of this rule must be accompanied by a
registrant representative at all times.
(b) A processing site registrant must maintain a log of all visitor activity and the log must contain
the first and last name and date of birth of every visitor, and the date they visited.
(7) Government Access. Nothing in this rule is intended to prevent or prohibit Authority employees
or contractors, or other state or local government officials that have jurisdiction over some aspectof the premises or a registered processing site to be on the premises.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
72 of 100 8/11/2016 2:13 P M(a) A visitor badge is not required for government officials.
(b)  A  processing  site  must  log  every  government  official that  enters  the  premises  but  the
processing site may not request that the government official provide a date of birth for the log.
(8) A registered processing site must have:(a) A designated limited access area or areas where transfers of marijuana items are received;
and
(b) A designated area where visitors enter the processing site premises and are checked in.
(9) The areas described in section (8) of this rule must be clearly marked on the floor or plot plan
sketch required in OAR 333-008-1650.
(10) Signage. A registered processing site must post:(a) At every entrance to  the processing site a sign that reads: “No  On-Site Consumption of
Marijuana”.
(b) At all areas of ingress to a limited access area signs that reads:
(A) “Restricted Access Area — Authorized Personnel Only”.
(B) “No Minors Allowed”.(11) A  processing site may not sublet or share with any other business any portion of  the
processing site premises, except as permitted in OAR 333-008-1790.
Stat. Auth.: ORS 475B.435Stats. Implemented: ORS 475B.435Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1740
Operation of Registered Processing Site
(1) Policies and Procedures. In order to be registered and remain registered a processing site
must create and maintain written, detailed standard policies and procedures that include but are
not limited to:
(a) Instructions for making each medical cannabinoid product, concentrate or extract.(b) The ingredients and the amount of each ingredient for each process lot.(c) The process for making each product.(d) The number of servings in a process lot.
(e) The intended amount of THC per serving and in a unit of sale of the product.
(f) The process for ensuring that the amount of THC is consistently distributed throughout each
process lot.
(g) If processing a cannabinoid concentrate or extract:(A) Conducting necessary safety checks prior to commencing processing; and(B)  Purging  any  solvent  or  other  unwanted  components  from  a  cannabinoid  concentrate  or
extract.
(h) Procedures for cleaning all equipment, counters and surfaces thoroughly.
(i) Proper handling and storage of any solvent, gas or other chemical used in processing or on the
processing site premises in accordance with material safety data sheets and any other applicablelaws.
(j) Proper disposal of any waste produced during processing in accordance with all applicable
local, state and federal laws, rules and regulations.
(k) Quality control procedures designed to, at a minimum, ensure that the amount of  THC is
consistently distributed throughout each process lot and that potential product contamination is
minimized.
(l) Appropriate use of any necessary safety or sanitary equipment.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
73 of 100 8/11/2016 2:13 P M(m) Emergency procedures to be followed in case of a fire, chemical spill or other emergency.
(n) Security.(o) Transfers of marijuana items to and from the processing site.(p) Testing.(q) Packaging and labeling if the processor intends to or is packaging and labeling marijuana items
after transfer to the processing site.
(r) Employee training.
(s) Compliance with these rules, including but not limited to violations and enforcement.(t)  Roles  and  responsibilities  for  employees  and  PRPs  in  assisting  the  Authority  during
inspections or investigations.
(2) Prohibitions. A registered processing site may not process or transfer a marijuana item:(a) That by its shape, design or flavor is likely to appeal to minors, including but not limited to:(A) Products that are modeled after non-cannabis products primarily consumed by and marketed
to children; or
(B) Products in the shape of an animal, vehicle, person or character.(b) That is made by applying cannabinoid concentrates or extracts to  commercially available
candy or snack food items.
(c) That contains dimethyl sulfoxide (DMSO).(3) Employees. A registered processing site may employ an individual between the ages of 18
and 20 if the individual is a patient. Otherwise, processing site employees must be 21 years of
age or older.
(4) Standardized Scales. In order to obtain a registration and to retain registration a processing
site registrant must own, maintain on the premises and use a weighing device that is licensed bythe Oregon Department of Agriculture. Licensed weighing devices must be used by a processingsite whenever marijuana items are:
(a) Transferred to or from the processing site and the transfer is by weight;(b) Packaged for transfer by weight; or
(c)  Weighed  for  purposes  of  documenting  information  required  in  OAR  333-008-1760,
333-008-1770, 333-008-1820, and 333-008-1830.
(5) Inventory Tracking and Point of  Sale System: A registered processing site must have an
integrated inventory tracking and point of sale system that can and does, at a minimum:
(a) Produce bar codes or similar unique identification numbers for each lot of  usable marijuana
transferred to a registered processing site and for each lot of a medical cannabinoid product,concentrate or extract transferred to a registered dispensary;
(b) Capture all information required to be documented in OAR 333-008-1760 and 333-008-1770;
(c) Generate inventory, transaction, transport and transfer reports requested by the Authority
viewable in PDF format; and
(d) Produce all the  information required  to  be  submitted to  the  Authority  pursuant to  OAR
333-0080-1830.
(6)  Online  Verification of  Registration Status.  A  registered  processing  site  must  verify  an
individual’s or processing site’s registration status with the Authority when receiving a transfer of a
marijuana item if the Authority has available an online system for such verification.
(7) Transfers from and to patients or designated primary caregivers.(a)  A  registered  marijuana  processing  site  may  transfer  a  medical  cannabinoid  product,
concentrate or extract to a patient, or a patient’s designated primary caregiver if the patient or thepatient’s designated primary caregiver provides the marijuana processing site with the marijuanato be processed into the medical cannabinoid product, concentrate or extract and the marijuanaprocessing site receives no compensation for the transfer of the marijuana.
(b) A registered processing site must document each transfer of marijuana by a patient or the
patient’s  designated  primary  caregiver  to  the  processing  site  in  accordance  with  OAROregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
74 of 100 8/11/2016 2:13 P M333-008-1760 and 333-008-1770.
(c)  A  registered  processing  site  must  document  each  transfer  of  a  cannabinoid  product,
concentrate or extract to a patient or the patient’s designated primary caregiver in accordancewith OAR 333-008-1760 and 333-008-1770.
(d) A registered processing site may be compensated by the patient or the patient’s designated
primary caregiver for all costs associated with the processing of marijuana for the patient.
(8) Inventory On-Site. Marijuana items must be kept on-site at the registered processing site. The
Authority may take enforcement action against a registered processing site if during an inspection
a processing site cannot account for its inventory or if  the amount of  usable marijuana at theprocessing site is not within five percent of the documented inventory.
(9) Testing.(a) Prior to  October 1,  2016,  a registered processing site must  comply  with the applicable
sampling and testing requirements in OAR 333-008-1190 or if  using an accredited laboratory,comply with OAR 333-007-0300 to 333-007-0490.
(b)  On  and  after  October  1,  2016,  a  registered  processing  site  must  comply  with  OAR
333-007-0300 to 333-007-0490 and may not:
(A) Accept a transfer of  a marijuana item that has not been tested in accordance with OAR
333-007-0300 to 333-007-0490.
(B) Transfer a medical cannabinoid product, concentrate or extract that has not been tested in
accordance with OAR 333-007-0300 to 333-007-0490.
(10) Packaging and Labeling.
(a) Prior to  October 1, 2016, a registered processing site must comply with the labeling and
packaging rules in OAR 333-008-1220 and 333-008-1225, 333-007-0010 to  333-007-0100 or845-025-7000 to 845-025-7020 and 845-025-7060.
(b) On and after October 1, 2016, a registered processing site must comply with the labeling
requirements in OAR 333-007-0010 to 333-007-0100, and the packaging requirements in OAR845-025-7000 to 845-025-7020 and 845-025-7060.
(11) Industrial Hemp Products. A processing site may only accept the transfer of and may only
transfer a product that contains THC or CBD that is derived from marijuana.
(12) Sampling. A registered processing site may provide a sample of a medical cannabinoid
product, concentrate or extract to a dispensary for the purpose of the dispensary determiningwhether to purchase the product, concentrate or extract but the product, concentrate or extractmay not be consumed on the processing site. Any sample provided to a dispensary must berecorded in the database.
(13) For purposes of this rule:
(a) “Lot of usable marijuana” means a quantity of usable marijuana transferred to a registered
processing site from the same harvest lot as that term is defined in OAR 333-007-0020; and
(b) “Lot of medical cannabinoid products, concentrates or extracts” means a quantity of a medical
cannabinoid product, concentrate or extract transferred to a registered dispensary at one time andthat is from the same process lot as that term is defined in OAR 333-007-0020.
Stat. Auth.: ORS 475B.435, 475B.440Stats. Implemented: ORS 475B.435, 475B.440
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1760Transfers to a Registered Processing Site
(1) Transfers of Marijuana by a Patient or Designated Primary Caregiver to Process for a Patient.
A patient or designated primary caregiver may transfer marijuana to a registered processing sitefor no compensation for the purpose of the registered processing site processing the marijuanainto a cannabinoid product, concentrate or extract.
(a) If a designated primary caregiver is transferring the marijuana, a registered processing site
may only accept a transfer of marijuana under this section if the caregiver provides the original ora copy of a valid Authorization to Transfer form prescribed by the Authority.
(b) In order to be valid an Authorization to Transfer form must include at least:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
75 of 100 8/11/2016 2:13 P M(A) The patient’s name, OMMP card number, OMMP receipt number if applicable and expiration
date and contact information;
(B) The name and contact information of the individual who is authorized to transfer the usable
marijuana  to  the  registered  processing  site  and  that  individual’s  OMMP  card  number  andexpiration date;
(C) The name and address of  the registered processing site that is authorized to receive the
usable marijuana; and
(D) The date the authorization expires, if earlier than the expiration date of the patient’s OMMP
card or receipt.
(2) Transfer of Usable Marijuana. A patient, caregiver, or PRMG may transfer usable marijuana to
a registered processing site, subject to the requirements in this rule.
(a) A registered processing site may only accept a transfer of usable marijuana if the individual
transferring the usable marijuana provides the original or a copy of a valid:
(A) Authorization to Transfer form prescribed by the Authority; or
(B) Personal agreement as that is defined in OAR 333-008-0010.
(b) Authorization to Transfer Forms. In order to be valid an Authorization to Transfer form must
include at least:
(A) The patient’s name, OMMP card number and expiration date and contact information;(B) The name and contact information of the individual who is authorized to transfer the usable
marijuana  to  the  registered  processing  site  and  that  individual’s  OMMP  card  number  andexpiration date;
(C) The name and address of  the registered processing site that is authorized to receive the
usable marijuana; and
(D) The date the authorization expires, if earlier than the expiration date of the patient’s OMMP
card.
(c) Personal Agreements. In order to be valid a personal agreement must include at least:(A) The patient’s name, OMMP card number and expiration date and contact information;
(B) The name and contact information of the PRMG to whom the patient’s property rights have
been assigned and the producer’s OMMP card number and expiration date;
(C) The portion of the patient’s rights to possess usable marijuana that is being assigned to the
producer.
(3) Transfer of medical cannabinoid products, concentrates or extracts. A registered processing
site may only accept a transfer of a medical cannabinoid product, concentrate or extract fromanother registered medical marijuana processing site.
(4) A registered processing site may only accept a transfer of a medical cannabinoid product,
concentrate  or  extract  from  a  registered  processing  site  that  provides  a  Processing  Site
Authorization to Transfer form, prescribed by the Authority. In addition the registered processingsite must obtain a copy of  the photo  identification of  the individual transferring the product,concentrate or extract as required in section (5)(b)(B) of this rule.
(5) Transfer Records. At the time marijuana, usable marijuana or a medical cannabinoid product,
concentrate  or  extract  is  transferred  to  a  registered  processing  site  a  processing  siterepresentative must:
(a) Document, as applicable:
(A) The weight in metric units of all usable marijuana received by the processing site;(B)  The  amount  of  a  medical  cannabinoid  product,  concentrate  or  extract  received  by  the
processing site, including, as applicable, the weight in metric units, or the number of units;
(C) The name of the usable marijuana or medical cannabinoid product, concentrate or extract;(D) The date the usable marijuana or medical cannabinoid product, concentrate or extract was
received; and
(E) The amount of reimbursement paid by the registered processing site.
(b) Obtain and maintain a copy of, as applicable:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
76 of 100 8/11/2016 2:13 P M(A) Documents required in section (1) of this rule including the date it was received;
(B)  The  photo  identification of  the  individual  transferring  the  usable  marijuana  or  medical
cannabinoid product, concentrate or extract to the registered processing site, if such a copy is notalready on file;
(C) The OMMP card of the individual transferring usable marijuana;(D) The medical marijuana processing site registration; and
(E) Test results for marijuana items transferred to the processing site unless the processing site
plans to arrange for the testing of the marijuana item.
(6) Prior to  October 1, 2016, if  a registered processing site accepts the transfer of  usable
marijuana or a medical cannabinoid product, concentrate or extract that has not been tested inaccordance with OAR 333-008-1190 or OAR 333-007-0300 to 333-007-0490 the processing sitemust segregate that item in accordance with OAR 333-008-1190(7).
(7) Once samples of  the usable marijuana or a medical cannabinoid product, concentrate or
extract have been taken for the purpose of  testing the item must be stored and secured in a
manner that prevents the product from being tampered with or transferred prior to test results
being reported.
(8) Nothing in these rules requires a registered processing site to accept a transfer of a marijuana
item.
(9) All documentation required in this  rule must be maintained electronically in an integrated
inventory tracking and point of sale system.
Stat. Auth.: ORS 475B.435, 475B.440
Stats. Implemented: ORS 475B.435, 475B.440
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1770
Transfers From a Registered Processing Site
(1)  A  registered  processing  site  must,  in  addition  to  the  completing  a  Processing  Site
Authorization to Transfer form, prescribed by the Authority, document the following for transfersto a registered dispensary or registered processing site:
(a) The name, address, and registration number of the dispensary or processing site to which a
medical cannabinoid product, concentrate or extract was transferred;
(b) The amount of medical cannabinoid product, concentrate, or extract transferred;
(c) The name of the medical cannabinoid product, concentrate, or extract transferred;
(d) The date of the transfer; and(e) The amount of money paid by the registered dispensary or processing site for the transfer.(2) A  registered processing site must document the following for the transfer of  a medical
cannabinoid product, concentrate or extract to a patient or designated primary caregiver pursuantto ORS 475B.443(1)(b) and (c):
(a) The name and registration number or OMMP receipt number of  the patient or designated
primary caregiver to which a medical cannabinoid product, concentrate or extract was transferred;
(b) If the medical cannabinoid product, concentrate or extract was transferred to a designated
primary  caregiver,  the  patient’s  name  and  registration number  for  whom  the  caregiver  wasreceiving the transfer;
(c) The amount of medical cannabinoid product, concentrate, or extract transferred;(d) The name of the medical cannabinoid product, concentrate, or extract transferred;
(e) The date of the transfer; and
(f) The amount of money paid by the patient or designated primary caregiver for the transfer.(3) All documentation required in this  rule must be maintained electronically in an integrated
inventory tracking and point of sale system.
Stat. Auth.: ORS 475B.435Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
77 of 100 8/11/2016 2:13 P MStats. Implemented: ORS 475B.435
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1780
General Processing Site Health and Safety Requirements
(1) A processing site must:(a) Use equipment, counters and surfaces for processing that are food-grade and do not react
adversely with any solvent being used.
(b) Have counters and surface areas that are constructed in a manner that reduce the potential for
development of microbials, molds and fungi and that can be easily cleaned.
(c) Maintain the processing site in a manner that is free from conditions which may result in
contamination and that is suitable to facilitate safe and sanitary operations for product preparationpurposes.
(2) A  processing site may  not treat  or otherwise adulterate a medical cannabinoid product,
concentrate  or  extract  with any  additives  that  would  increase  potency,  toxicity,  or  addictivepotential,  or  that  would  create  an unsafe  combination with other  psychoactive  substances.Prohibited additives include but are not limited to nicotine, alcohol, caffeine, or chemicals thatincrease carcinogenicity.
Stat. Auth.: ORS 475B.435, 475B.440
Stats. Implemented: ORS 475B.435, 475B.440Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1790
Cannabinoid Edible Processor Requirements
(1)  A  processing  site  endorsed  to  make  cannabinoid  edibles  may  only  process  in a  food
establishment licensed by the Oregon Department of Agriculture (ODA) and must comply with theapplicable provisions of OAR chapter 603, division 21, division 24, division 25, with the exceptionof OAR 603-025-0020(17), and division 28.
(2) A processing site endorsed to make cannabinoid edibles may not:
(a) Engage in processing in a location that is operating as a restaurant, seasonal temporary
restaurant, intermittent temporary restaurant, limited service restaurant or single-event temporaryrestaurant licensed under ORS chapter 624;
(b) Share a food establishment with a person not registered with the Authority as a cannabinoid
edible processor;
(c) Process cannabinoid edibles and food in the same food establishment; or(d) Use a cannabinoid concentrate or extract in a cannabinoid edible unless that concentrate or
extract was processed in a food establishment licensed by ODA under OAR chapter 603, division
21, division 24, division 25, with the exception of OAR 603-025-0020(17), and division 28.
(3) A processing site endorsed to make cannabinoid edibles may share a food establishment with
another Authority registered cannabinoid edible processor if:
(a)  The  schedule,  with  specific  hours  and  days  that  each  processor  will  use  the  food
establishment, is prominently posted at the entrance to the food service establishment.
(b) Each registrant designates a separate area to secure, in accordance with OAR 333-008-2080
any marijuana, medical cannabinoid products, concentrates or extracts that a registrant stores at
the food establishment. If  a cannabinoid edible processor does not store marijuana, medicalcannabinoid products, concentrates or extracts at the food establishment those items must bestored on a registered processing site under the processor’s control.
(4) A food establishment used by a processing site endorsed to make cannabinoid edibles is
considered  a  registered  processing  site  and  must  meet  the  security  and  other  premisesrequirements in these rules.
(5) A processing site endorsed to make cannabinoid edibles is strictly liable for any violation
found at a shared food establishment during that processor’s scheduled time, as reflected on theposted schedule or within that processor’s designated area in the food establishment.
(6) If the Authority cannot determine by viewing the schedule or video surveillance footage whoOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
78 of 100 8/11/2016 2:13 P Mwas responsible for the violation, each processor at the shared food establishment is individually
and jointly liable for any documented violations.
(7) A processing site must make cannabinoid edibles in a manner that results in the THC being
distributed consistently throughout the edible.
Stat. Auth.: ORS 475B.435 & 475B.440Stats. Implemented: ORS 475B.435 & 475B.440
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1800Cannabinoid Concentrate and Extract Processor Requirements
(1) Cannabinoid Concentrates or Extracts. A  processing site endorsed to  make cannabinoid
concentrates or extracts:
(a) May not use Class I solvents as those are classified in the Federal Drug Administration
Guidance, Table I, published in the Federal Register on December 24, 1997 (62 FR 67377).
(b) Must:(A) Only use a hydrocarbon-based solvent that is at least 99 percent purity.(B) Only use a non-hydrocarbon-based solvent that is food-grade.
(C) Work in an environment  with proper ventilation,  controlling  all sources  of  ignition where  a
flammable atmosphere is or may be present.
(D) Use only potable water and ice made from potable water in processing.(E) If making a concentrate or extract that will be used in a cannabinoid edible, be endorsed as a
cannabinoid edible processor.
(2) Cannabinoid Extracts. A processing site endorsed to make cannabinoid extracts:(a) May not use pressurized canned flammable fuel, including but not limited to butane and other
fuels intended for use in camp stoves, handheld torch devices, refillable cigarette lighters and
similar consumer products
(b) Must:(A) Process in a:(i) Fully enclosed room clearly designated on the current diagram of the registered premises.(ii) Room and with equipment, including all electrical installations, that meet the requirements of
the Oregon Structural Specialty Code, related Oregon Specialty Codes and the Oregon Fire
Code..
(B) Use a commercially manufactured professional grade closed loop extraction system designed
to  recover  the  solvents  and  built  to  recognized  and  generally  accepted  good  engineeringstandards, such as those of:
(i) American National Standards Institute (ANSI);(ii) Underwriters Laboratories (UL); or(iii) The American Society for Testing and Materials (ASTM).
(C) If using carbon dioxide in processing, use a professional grade closed loop carbon dioxide
gas extraction system where every vessel is rated to a minimum of 600 pounds per square inch.
(D) For extraction system engineering services, including but not limited to consultation on and
design of  extraction systems  or components  of  extraction systems,  use  the  services  of  aprofessional engineer registered with the Oregon State Board of Examiners for Engineering andLand Surveying, unless an exemption under ORS 672.060 applies;
(E) Have an emergency eye-wash station in any room in which cannabinoid extract is being
processed.
(F) Have all applicable material safety data sheets readily available to personnel working for the
processor.
(3) Cannabinoid Concentrates. A processing site endorsed to make cannabinoid concentrates:Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
79 of 100 8/11/2016 2:13 P M(a) May not:
(A) Use denatured alcohol.(B) If using carbon dioxide, apply high heat or pressure.(b) Must only use or store dry ice in a well ventilated room to prevent against the accumulation of
dangerous levels of carbon dioxide.
(c) May use:
(A) A mechanical extraction process;
(B) A chemical extraction process using a nonhydrocarbon-based or other solvent, such as water,
vegetable glycerin, vegetable oils, animal fats, isopropyl alcohol or ethanol; or
(C) A chemical extraction process using the hydrocarbon-based solvent carbon dioxide, provided
that the process does not involve the use heat over 180 degrees or pressure.
Stat. Auth.: ORS 475B.435, 475B.440Stats. Implemented: ORS 475B.435, 475B.440
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
28-16
333-008-1810
Cannabinoid Topical Processor
(1) A processing site endorsed to make cannabinoid topicals, tinctures, capsules, suppositories
or transdermal patches  may  not  engage  in processing in a  location that  is  operating  as  arestaurant,  seasonal  temporary  restaurant,  intermittent  temporary  restaurant,  limited  servicerestaurant or single-event temporary restaurant licensed under ORS chapter 624.
(2)  A  registered  processing  site  making  cannabinoid  tinctures  may  only  process  in  a  food
establishment licensed by the Oregon Department of Agriculture (ODA) and must comply with the
applicable provisions of OAR chapter 603, division 21, division 24, division 25, with the exception
of OAR 603-025-0020(17), and division 28.
Stat. Auth.: ORS 475B.435, 475B.440Stats. Implemented: ORS 475B.435, 475B.440Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-1830
Registered Marijuana Processing Site Required Reporting to the Authority
(1)  The  individual or  individuals  responsible  for  a  marijuana  processing  site  shall maintain
documentation of each transfer of usable marijuana, medical cannabinoid products, cannabinoidconcentrates  and  cannabinoid  extracts  and  on and  after  June  1,  2016,  must  submit  to  the
Authority electronically, by the 10th of each month, the following information:
(a) The amount  of  usable marijuana transferred to  the marijuana processing site during the
previous month.
(b) The amount and type of a medical cannabinoid concentrate or extract transferred by another
registered processing site during the previous month. For purposes of this section “type” means:
(A) Cannabinoid concentrate in solid form; and(B) Cannabinoid concentrate in liquid form.
(c) The amount and type of medical cannabinoid products transferred by the marijuana processing
site to a dispensary. For purposes of this section “type” means:
(A) Cannabinoid edibles;(B) Cannabinoid topicals;(C) Cannabinoid tinctures;(D) Cannabinoid capsules;
(E) Cannabinoid suppositories;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
80 of 100 8/11/2016 2:13 P M(F) Cannabinoid transdermal patches; and
(G) Cannabinoid product other than products listed in paragraphs (A) to (F) of this subsection.(d) The amount and type of cannabinoid concentrates transferred by the marijuana processing
site during the previous month. For purposes of this section “type” means:
(A) Cannabinoid concentrate in solid form; and(B) Cannabinoid concentrate in liquid form.
(e) The amount and type of cannabinoid extracts transferred by the marijuana processing site
during the previous month. For purposes of this section “type” means:
(A) Cannabinoid extract in solid form; and(B) Cannabinoid extract in liquid form.(f) The amount and type of medical cannabinoid products transferred by the marijuana processing
site to a patient or the patient’s designated primary caregiver during the previous month. Forpurposes of this section “type” means:
(A) Cannabinoid edibles;
(B) Cannabinoid topicals;(C) Cannabinoid tinctures;(D) Cannabinoid capsules;(E) Cannabinoid suppositories;(F) Cannabinoid transdermal patches; and(G) Cannabinoid product other than products listed in paragraphs (A) to (F) of this subsection.
(g) The amount and type of cannabinoid concentrates or extracts transferred by the marijuana
processing site to  a patient or the patient’s designated primary caregiver during the previousmonth. For purposes of this section “type” means;
(A) Cannabinoid concentrate or extract in liquid form; and(B) Cannabinoid concentrate or extract in solid form.(2) Information submitted to the Authority under this rule must:
(a) List each type of marijuana item separately;
(b) Provide the total aggregate amount of a type of marijuana item transferred to a processing
site by a patient, designated primary caregiver, PRMG or other registered processing site duringthe previous month; and
(c) Provide the total aggregate amount of a type of marijuana item transferred from a processing
site  to  a  registered  dispensary,  patient,  designated  primary  caregiver,  or  other  registeredprocessing site during the previous month.
(3) In addition to  submitting the information as required by section (1) of  this rule, a person
responsible for a processing site must keep a record of the information described in section (1) ofthis rule for two years after the date on which the person submits the information to the Authority.
Stat. Auth.: ORS 475B.438Stats. Implemented: ORS 475B.438Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-2030
Notification of Changes
(1) A registrant must notify the Authority within 10 calendar days of any of the following:(a) The conviction for the manufacture or delivery of  a controlled substance in Schedule I or
Schedule II of any individual named in the application;
(b) A  change in any contact information for anyone listed in an application or subsequently
identified as an owner, an individual with a financial interest, a PRD or a PRP;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
81 of 100 8/11/2016 2:13 P M(c) A decision to remove a PRD, PRP, primary PRD or primary PRP;
(d) A decision to permanently close the dispensary or processing site at that location;(e) For a dispensary, the location of a public or private elementary or secondary school within
1,000 feet of the dispensary; and
(f) The suspected theft of marijuana items.(2) The notification required in section (1) of this rule must include a description of what has
changed or the event and any documentation necessary for the Authority to determine whether the
dispensary or processing site or dispensary or processing site registrant is still in compliance withORS 475B.435, 475B.450 and these rules including but not limited to, as applicable:
(a) A copy of the criminal judgment or order;(b)  The  location of  the  school that  has  been identified  as  being  within 1,000  feet  of  the
dispensary; or
(c) A copy of  the police report documenting that the suspected theft of  marijuana items was
reported to law enforcement, if it was reported.
(3) Changes in Ownership, Financial Interest or Business Structure. A registrant that proposes to
change its corporate structure, ownership structure or change who has a financial interest in thebusiness must submit a form prescribed by the Authority, any information identified in the form tobe submitted, and criminal background check fees, if applicable, to the Authority, prior to makingsuch a change.
(a) The Authority must review the form and other information submitted and will approve the
change if  the change would not  result  in an initial or renewal application denial under OAR
333-008-1060 or 333-008-1670, or serve as the basis of a registration suspension or revocation.
(b) If the Authority denies the change but the registrant proceeds with the change the registrant
must surrender the registration or the Authority will propose to suspend or revoke the registration.
(4) Failure of  a registrant to notify the Authority in accordance with this rule may result in the
imposition of civil penalties or the suspension or revocation of a dispensary or processing site’sregistration.
Stat. Auth.: ORS 475B.435, 475B.450, 475B.525
Stats. Implemented: ORS 475B.435, 475B.450
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-2080
Security Requirements
In order to be registered and remain registered a registrant must:(1) Have an installed and fully operational security alarm system, installed by an alarm installation
company, activated at all times when the premises is closed for business on all:
(a) Entry or exit points to and from the premises; and(b) Perimeter windows, if applicable.
(2) Have a security alarm system that:
(a) Detects movement inside the premises;(b) Is programmed to notify a security company that will notify a registrant representative or his or
her designee in the event of a breach; and
(c) Has at least two operational “panic buttons” located inside the premises that are linked with the
alarm system that notifies a security company.
(3) Have commercial grade, non-residential door locks installed on every external door of  a
registered premises where marijuana items are present.
(4) During all hours when the registrant is not operating:(a) Securely lock all entrances to and exits from the registered premises and ensure any keys or
key  codes  to  the  enclosed  area  remain in the  possession of  the  registrant  or  registrantrepresentative;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
82 of 100 8/11/2016 2:13 P M(b) Have a safe or vault as those terms are defined in OAR 333-008-0010 for the purpose of
securing all marijuana items as required by these rules.
(5) Have a password protected network infrastructure.(6) Have an electronic back-up system for all electronic records.(7) Keep all video recordings and archived required records not stored electronically in a locked
storage area. Current records may be kept in a locked cupboard or desk outside the lockedstorage area during hours when the registered business is open.
Stat. Auth.: ORS 475B.435, 475B.450, 475B.525
Stats. Implemented: ORS 475B.435, 475B.450Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-2090
Video Surveillance Equipment
In order to be registered and remain registered a registrant must:(1)  Have  an installed  and  fully  operational video  surveillance  recording  system  with video
surveillance equipment that at a minimum:
(a) Consists of:
(A) Digital or network video recorders;
(B) Cameras capable of meeting the requirements of OAR 333-008-2110 and this rule;(C) Video monitors;(D) Digital archiving devices;(E) A minimum of one monitor on premises capable of viewing video; and(F) A color printer capable of producing still photos.
(b)  Is  equipped  with  a  failure  notification  system  that  immediately  notifies  a  registrant
representative of any surveillance interruption or failure that is longer than five minutes; and
(c) Has sufficient battery backup to support a minimum of one hour of recording time in the event
of a power outage.
(2) Have a video surveillance system ca pable of recording all pre-determined surveillance areas in
any lighting conditions.
(3) Have, in limited access and point of sale areas, cameras that have minimum resolution of
1280 x 720 pixels (px) and record at 10 fps (frames per second).
(4) Have, in exterior perimeter and non-limited access areas (except for restrooms) cameras that
have a minimum resolution of 1280 x 720 px and record at least 5 fps, except where coverageoverlaps any limited access areas such as entrances or exits and in those overlap areas camerasmust record at 10 fps.
Stat. Auth.: ORS 475B.435, 475B.450, 475B.525Stats. Implemented: ORS 475B.435, 475B.450
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-2100Required Camera Coverage and Camera Placement
In order to be registered and remain registered a registrant must:
(1) Have security camera coverage for:(a) All secure and limited access areas;(b) All areas where marijuana items will be and are transferred to or from a registered premises;(c) All areas where the general public is permitted (except for restrooms);(d) All points of entry to and exit from limited access areas and areas where marijuana items willOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
83 of 100 8/11/2016 2:13 P Mbe and are transferred to or from a registered premises; and
(e) All points of entry to and exit from the premises.(2) Have cameras that are positioned so  that they capture clear and certain images of  any
individual and activity occurring:
(a) Within 15 feet both inside and outside of all points of entry to and exit from the premises;(b) Anywhere within a secure or limited access area on the premises; and
(c) Anywhere within an area where marijuana items will be and are transferred to  or from a
registered premises.
Stat. Auth.: ORS 475B.435, 475B.450, 475B.525Stats. Implemented: ORS 475B.435, 475B.450Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-2110
Video Recording Requirements
(1) In order to be registered and remain registered a registrant must:(a) Have cameras that are installed, operational, and continuously record 24 hours a day in all
areas where marijuana items will be or are on the premises, including areas where the general
public is permitted (except restrooms).
(b) Use cameras that record at a minimum resolution of 1280 x 720 px;(c) Have an installed and operational surveillance system that:(A) Can produce a color still photograph from any camera image; and(B) Embeds the date and time on all surveillance recordings without significantly obscuring the
picture;
(2) A registrant must:
(a) Keep all surveillance recordings a minimum of 45 calendar days and in a format that can be
easily accessed for viewing;
(b) Archive  video  recordings  in a  format  that  ensures  authentication of  the  recording  as  a
legitimately-captured video and guarantees that no alterations of the recorded image has takenplace;
(c) Provide video surveillance records and recordings immediately upon request to the Authority
for the purpose of ensuring compliance with ORS 475B.450 and these rules;
(d) Keep surveillance recordings for periods exceeding 45 calendar days upon request of  the
Authority; and
(e) Immediately notify the Authority of any equipment failure or system outage lasting 30 minutes
or more.
Stat. Auth.: ORS 475B.435, 475B.450, 475B.525Stats. Implemented: ORS 475B.435, 475B.450
Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-2180Violations
(1) It is a violation for an applicant for a registration, registrant or registrant representative to:
(a) Fail to cooperate with an inspection;(b) Submit false or misleading information to the Authority;(c) If the registrant is a dispensary, transfer a marijuana item to an individual who is not a patient
or a designated primary caregiver;
(d) If the registrant is a processing site, transfer a medical cannabinoid product, concentrate or
extract to anyone who is not a dispensary representative or a patient;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
84 of 100 8/11/2016 2:13 P M(e) Accept the transfer of  a marijuana item from an individual who  is not registered with the
Authority;
(f) Accept the transfer of a marijuana item that was produced or processed in another state;(g) Possess a mature marijuana plant;(h) Fail to submit a plan of correction in accordance with OAR 333-008-2190;(i) Fail to comply with an emergency suspension order or final order of the Authority, including
failing to pay a civil penalty;
(j) Fail to comply with ORS 475B.435 to 475B.443, 475B.450 to 475B.453, 475B.555, 475B.605,
475B.615, these rules, or OAR chapter 333, division 7; or
(k) Alter or falsify a laboratory test report or result.(l) Alter or falsify a receipt issued under OAR 333-008-0023 or 333-008-0040(2) It is a violation of  ORS 475B.450 and these rules to  operate a dispensary without being
registered by the Authority.
(3) It is a violation of ORS 475B.435 and these rules to operate a processing site without being
registered by the Authority unless an exemption applies.
Stat. Auth.: ORS 475B.435, 475B.450 & 475B.525Stats. Implemented: ORS 475B.435 & 475B.450Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-008-2190
Enforcement
(1)(a) Informal Enforcement. If, during an inspection the Authority documents violations of ORS
475B.435 to 475B.443, 475B.450 to 475B.453, 475B.555, 475B.605, 475B.615, any of  theserules or OAR chapter 333, division 7, the Authority may issue a written Notice of Violation to a
registrant  that  cites  the  laws  alleged  to  have  been violated  and  the  facts  supporting  the
allegations.
(b) A registrant must submit to the Authority a signed plan of correction within 10 business days
from the date the Notice of Violation was mailed by the Authority. A signed plan of correction willnot be used by the Authority as an admission of the violations alleged in the Notice.
(c) A registrant must correct all deficiencies within 10 business days from the date of the Notice,
unless an extension of time is requested from the Authority. A request for such an extension shall
be submitted in writing and must accompany the plan of correction.
(d) The Authority must determine if  a written plan of  correction is acceptable. If  the plan of
correction is not acceptable to the Authority it must notify the registrant in writing and request thatthe plan of correction be modified and resubmitted no later than 10 business days from the datethe letter of non-acceptance was mailed.
(e) If the registrant does not come into compliance by the date of correction reflected on the plan
of correction, the Authority may propose to suspend or revoke the registrant’s registration orimpose civil penalties.
(f) The Authority may conduct an inspection at any time to determine whether a registrant has
corrected the deficiencies in a Notice of Violation.
(2) Formal Enforcement. If, during an inspection or based on other information the Authority
determines that a registrant is in violation of ORS 475B.435 to 475B.443, 475B.450 to 475B.453,475B.555, 475B.605, 475B.615, any of these rules or OAR chapter 333, division 7 the Authoritymay issue:
(a) A Notice of Proposed Suspension or Revocation in accordance with ORS 183.411 through
183.470.
(b) A Notice of Imposition of Civil Penalties in accordance with OAR 333-008-2200.(c) An Order of Emergency Suspension pursuant to ORS 183.430.(3) The Authority must determine whether to use the informal or formal enforcement process
based on the nature of the alleged violations, whether there are mitigating or aggravating factors,and whether the registrant has a history of violations.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
85 of 100 8/11/2016 2:13 P M(4) The Authority must issue a Notice of Proposed Revocation if the registrant no longer meets
the criteria in ORS 475B.450(3)(a) to (d) or ORS 475B.435(3)(a) or (b).
(5) The Authority may issue civil penalties or maintain a civil action against an establishment
providing the services of a processing site or dispensary but is not registered in accordance withORS 475B.450, ORS 475B.435 and these rules.
(6)  The  Authority  may  revoke  the  registration of  a  registrant  for  failure  to  comply  with an
ordinance adopted by a city or county pursuant to ORS 475B.500, if the city or county:
(a) Has provided the registrant with due process substantially similar to the due process provided
to a registration holder under the Administrative Procedures Act, ORS 183.413 to 183.470; and
(b) Provides the Authority with a final order that is substantially similar to the requirements for a
final order under ORS 183.470 that establishes the registrant is in violation of the local ordinance.
(7) The Authority must post a final order revoking the registration of a registrant on the Authority’s
website.
(8) To the extent permitted by law, if the Authority discovers violations that may constitute criminal
con d u ct or con d u ct th a t is in viol ation of l a w s w ith in th e j u r isd iction of oth e r sta te or l ocal
governmental entities, the Authority may refer the matter to the applicable agency.
(9) If the registration of a registrant is revoked the owner or an authorized representative of the
owner must:
(a) Make arrangements to return the marijuana items still possessed at the location to the person
who transferred the marijuana item, document the return, and provide this information in writingwithin one business day of the transfer, to the Authority; or
(b) Dispose of the marijuana items in a manner specified by the Authority.
(10) The Authority is not required to accept the surrender of a registration and may proceed with
an enforcement action even if a registrant has surrendered the registration.
(11) Notwithstanding OAR 333-008-3000 if the Authority suspends or revokes a registration or
otherwise  takes  disciplinary  action  against  the  registrant  the  Authority  must  provide  thatinformation to a law enforcement agency.
(12) The  Authority  may  possess,  seize or dispose of  marijuana,  usable marijuana,  medical
cannabinoid products, cannabinoid concentrates and cannabinoid extracts as is necessary for the
Authority to ensure compliance with and enforce the provisions of ORS 475B.435 to 475B.443,475B.450 to 475B.453, 475B.555, 475B.605, 475B.615, any of these rules or OAR chapter 333,division 7.
Stat. Auth.: ORS 431A.010, 475B.435, 475B.450 & 475B.525Stats. Implemented: ORS 475B.435 & 475B.450Hist.: PH 9-2016, f. 2-26-16, cert. ef. 3-1-16; PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
333-064-0100
Marijuana Item Sampling Procedures and Testing
(1) For purposes  of  this  rule the definitions in OAR  333-007-0310 apply  unless the context
indicates otherwise.
(2) Sampling.(a) A laboratory must prepare marijuana item sampling policies and procedures that contain all of
the information necessary for collecting and transporting samples from a marijuana item in amanner that does not endanger the integrity of the sample for any analysis required by this rule.These policies and procedures must be appropriate to the matrix being sampled.
(b) Sampling policies and procedures must be accredited by ORELAP prior to any marijuana
samples being taken. The policies and procedures must be consistent with the following ORELAP
sampling protocols approved by the accrediting body, incorporated by reference:
(A) Usable Marijuana: ORELAP-SOP-001 Rev 2.0;(B) Concentrates and Extract: ORELAP-SOP-002 Rev 2.0; and(C) Cannabis Products: ORELAP-SOP-003 Rev 2.0. [Sampling protocols may be found on the
ORELAP  and  Cannabis  Testing  webpage,  public.health.oregon.gov/LaboratoryServices/EnvironmentalLaboratoryAccreditation/Pages/cannabis-info.aspx]Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
86 of 100 8/11/2016 2:13 P M(c) Care should be taken by laboratory personnel while sampling to avoid contamination of the
non-sampled material. Sample containers must be free of analytes of interest and appropriate forthe analyses requested.
(d) A sufficient sample size must be taken for analysis of  all requested tests and the quality
control performed by the testing laboratory for these tests.
(e) A laboratory must comply with any recording requirements for samples and subsamples in the
accredited policies and procedures and at a minimum:
(A) Record the location of each sample and subsample taken.
(B) Assign a field identification number for each sample, subsample and field duplicate that have
an unequivocal link to the laboratory analysis identification.
(C)  Assign  a  unique  identification  number  for  the  test  batch  in  accordance  with  OAR
333-007-0370 and TNI EL standard requirements.
(D) Have a documented system for uniquely identifying the samples to be tested to ensure there
can be no confusion regarding the identity of such samples at any time. This system must include
identification  for  all  samples,  subsamples,  preservations,  sample  containers,  tests,  and
subsequent extracts or digestates.
(E) Place the laboratory identification code as a durable mark on each sample container.(F) Enter a unique identification number into the laboratory records. This number must be the link
that associates the sample with related laboratory activities such as sample preparation. In caseswhere the sample collector and analyst are the same individual, or the laboratory pre-assignsnumbers to  sample containers, the unique identification number may  be the same as the field
identification code.
(f) Combining subsamples.(A) Subsamples collected from the same batch must be combined into  a single sample by a
laboratory prior to testing unless the batch is undergoing process validation or has not yet gonethrough process validation.
(B) Subsamples and samples collected from different batches may not be combined.(C) Field duplicates may not be combined with the primary samples.
(3) THC and CBD testing validity. When testing a sample for THC and CBD a laboratory must
comply with additional method validation as follows:
(a) Run a laboratory control standard in accordance with TNI standards requirements  within
acceptance criteria of 70 percent to 130 percent recovery.
(b) Analyze field duplicates of samples within precision control limits of plus or minus 20 percent
RPD, if field duplicates are required.
(4) Calculating total THC and total CBD.
(a) Total THC must be calculated as follows, where M is the mass or mass fraction of  delta-9
THC or delta-9 THCA:
M total delta-9 THC = M delta-9 THC + 0.877 x M delta-9 THCA.(b) Total CBD must be calculated as follows, where M is the mass or mass fraction of CBD and
CBDA: M total CBD = M CBD + 0.877 x M CBDA.
(c) Each test report must include the total THC and total CBD.(5) Report total THC and total CBD as Dry Weight. A laboratory must report total THC and Total
CBD content by dry weight calculated as follows:
P total THC(dry) = P total THC(wet) / [1-(P moisture/100)]P total CBD(dry) = P total CBD(wet) / [1-(P moisture/100)](6) Calculating RPD and RSD.(a) A laboratory must use the following calculation for determining RPD: RPD=  (sample result–
duplicate result)(sample result+duplicate result 2
(b) A  laboratory  must  use  the  following  calculation for  determining  RSD:  RSD= sx  x100%
s=i=0n(xi–x) 2(n–1)Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
87 of 100 8/11/2016 2:13 P M(c) For purposes of this section:
(A) S = standard deviation.(B) n = total number of values.(C) xi = each individual value used to calculate mean.(D) x = mean of n values.(d) For calculating both RPD and RSD if any results are less than the LOQ the absolute value of
the LOQ is used in the equation.
(7) Tentative Identification of Compounds (TIC).(a) If a laboratory is using a gas chromatography mass spectrometry instrument for analysis when
testing cannabinoid concentrates or extracts for solvents and determines that a sample maycontain compounds that are not included in the list of analytes the laboratory is testing for thelaboratory must attempt to achieve tentative identification.
(b)  Tentative  identification is  achieved  by  searching  NIST  2014  or  an equivalent  database
(>250,000 compounds).
(c) A laboratory shall report to the licensee or registrant and the Authority or the Commission,
depending on which agency has jurisdiction, up to five tentatively identified compounds (TICS)that have the greatest apparent concentration.
(d) Match scores for background subtracted or deconvoluted spectra should exceed 90 percent
compared to library spectrum.
(A) The top five matches over 90 percent must be reported by the lab
(B) TIC quantitation is estimated by comparing analyte area to the closest internal standard area
and assuming a response factor (RF) =1.
(8) A laboratory must provide:(a) Any pesticide test result to the Department of Agriculture upon that agency’s request.(b) A sample or a portion of  a sample to  the Department of  Agriculture upon that agency’s
request, document the chain of custody from the laboratory to the Department, and document thatthe sample or portion of the sample was provided to the Department in the Commission’s seed to
sale tracking system.
(9) A  laboratory  performing tests for a licensee must enter any information required by the
Commission in the Commission’s seed to sale tracking system.
(10)  A  laboratory  performing  tests  for  a  registrant  must  comply  with  the  documentation
requirements in OAR 333-007-0370.
(11) The Authority may, in its discretion, deviate from TNI Standards in order to comply with OAR
333-007-0400 to 333-007-0490 and these rules based on the state’s needs.
Stat. Auth.: ORS 438.605, 438.610, 438.615 & 438.620, ORS 475B.555.
Stats. Implemented: ORS 438.605, 438.610, 438.615 & 438.620, ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
333-064-0110
Reporting Marijuana Test Results
(1) For purposes  of  this  rule the definitions in OAR  333-007-0310 apply  unless the context
indicates otherwise.
(2) Within 24 hours of  completion of  the laboratory’s data review and approval procedures a
laboratory  must  report  all  failed  tests  for  testing  required  under  OAR  333-007-0300  to
333-007-0490 except for failed water activity, whether or not the lab is reanalyzing the sample
under OAR 333-007-0450:
(a) Into the Commission’s seed to sale tracking system if performing testing for a licensee; and(b) To  the Authority  electronically  at  www.healthoregon.org/ommp if  performing testing for a
registrant.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
88 of 100 8/11/2016 2:13 P M(3) The laboratory must report all test results required under OAR 333-007-0300 to 333-007-0490
that have not been reported under section (2) of this rule into the Commission’s seed to saletracking system if performing testing for a licensee.
(4) A laboratory must determine and include on each test report its limit of quantification (LOQ) for
each analyte listed in OAR 333-007-0400 Table 3 and OAR 333-007-0410 Table 4.
(5) When reporting pesticide testing results the laboratory must include in the report any target
compound that falls below the LOQ that has a signal to noise ratio of greater than 3:1 and meets
identification criteria with a result of “detected.”
(6) A test report must include any associated test batch numbers and the date each test was
completed.
(7)  A  laboratory  that  is  reporting  failed  test  results  to  the  Commission or  the  Authority  in
accordance with section (2) of this rule must report the failed test at the same time or beforereporting to the licensee or registrant.
(8) In addition to reporting failed test results in accordance with section (2) of this rule a laboratory
conducting  testing  for  a  registrant  must  report  to  the  Authority  electronically  at
www.healthoregon.org/ommp  any  pesticide  testing  report  with a  “detected”  as  described  insection (5) of this rule.
(9) Test results expire after one year.Stat. Auth.: ORS 475B.555Stats. Implemented: ORS 475B.555Hist.: PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert.
ef. 6-28-16
Rule Caption: Hospital Nurse Staffing
Adm. Order No.:  PH 22-2016
Filed with Sec. of State:  7-1-2016
Certified to be Effective:  7-1-16
Notice Publication Date:  5-1-2016
Rules  Adopted:  333-510-0105,  333-510-0110,  333-510-0115,  333-510-0120,  333-510-0125,
333-510-0130, 333-510-0135, 333-510-0140
Rules Amended:  333-501-0035, 333-501-0040, 333-501-0045, 333-510-0002, 333-510-0045
Subject:  The  Oregon Health Authority,  Public  Health Division is  permanently  adopting  and
amending Oregon Administrative Rules relating to hospital nurse staffing in response to legislation(SB 469, Oregon Laws 2015, chapter 669) that was passed in the 2015 legislative session.
 The proposed rulemaking clarifies rules regarding: - Audit and complaint investigation procedures; - Civil penalties for violations of nurse staffing laws;
 - Nurse staffing law definitions;
 - Hospital posting and record keeping requirements; - Hospital nurse staffing committee requirements; - Hospital nurse staffing plans and plan review requirements; - Replacement nurse staffing requirements; - Nursing staff member overtime;
 - Waivers to nurse staffing plan requirements; and
 - Minor housekeeping corrections for ease of readability and alignment with other state agency
rules.
Rules Coordinator:  Tracy Candela—(971) 673-0561Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
89 of 100 8/11/2016 2:13 P M333-501-0035
Nurse Staffing Audit Procedure
(1) The Authority shall conduct an on-site audit of  each hospital once every three years  to
determine compliance with the requirements  of  ORS  441.152 to  441.177 and 441.192. The
Authority shall notify the hospital and both co-chairs of the hospital nurse staffing committee threebusiness days in advance of the audit.
(2) During an audit, the Authority shall review any hospital record and conduct any interview or site
visit that is necessary to determine that the hospital is in compliance with the requirements ofORS 441.152 to 441.177 and 441.192.
(3) In conducting an audit, the Authority shall interview:
(a) Both co-chairs of the hospital nurse staffing committee; and
(b) Any  additional hospital staff  members  deemed  necessary  to  determine  compliance with
applicable nurse staffing laws. Interviews may address, but are not limited to, the following topics:
(A) Implementation and effectiveness of the hospital-wide staffing plan for nursing services;(B) Input, if any, provided to the hospital nurse staffing committee; or(C) Any other fact relating to hospital nursing services subject to the Authority’s review.
(4) In conducting an audit, the Authority may also interview:
(a) Hospital staff that does not voluntarily come forward for an interview during an audit; and(b) Hospital patients or family members. Interviews may address, but are not limited to, any
concerns or complaints related to nurse staffing in the hospital.
(5) Following an audit, the Authority shall issue a written survey report that communicates the
results of the audit no more than 30 business days after the survey closes. This survey report:
(a) Shall be issued to the hospital and both co-chairs of the hospital nurse staffing committee; and
(b)  May  include  a  notice  of  civil  penalties  that  complies  with  ORS  441.175  and  OAR
333-501-0045.
(6) If the survey report identifies any area of noncompliance, the hospital shall submit a written
plan to correct each identified deficiency. This plan:
(a) Shall be called the plan of correction;(b) Shall be submitted no  more than 30 business days after receiving the Authority’s survey
report; and
(c) Shall be evaluated by the Authority for sufficiency.
(7) No more than 30 business days after receipt of the hospital’s plan of correction, the Authority
shall issue a written determination that communicates whether the plan of correction is sufficient.This determination:
(a) Shall be issued to the hospital and both co-chairs of the hospital nurse staffing committee; and(b) Shall require the hospital to either:(A) Revise and resubmit the rejected plan of correction no more than 30 business days after
receiving the Authority’s determination that the plan is insufficient; or
(B) Implement the approved plan of correction no more than 45 business days after receiving the
Authority’s determination that the plan is sufficient.
(8) Following the approval of the plan of correction, the Authority shall conduct a second audit of
the hospital to verify that the hospital has implemented the approved plan of correction. This auditshall be conducted within 60 business days of the plan of correction approval date.
(9) The identity of an individual providing evidence during an audit will be kept confidential to the
extent permitted by law.
Stat. Auth.: ORS 413.042, 441.157 & 441.175Stats. Implemented: ORS 441.157Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10; PH 26-2010,Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
90 of 100 8/11/2016 2:13 P Mf. 12-14-10, cert. ef. 12-15-10; PH 22-2016, f. & cert. ef. 7-1-16
333-501-0040Nurse Staffing Complaint Investigation Procedures
(1)  The  Authority  shall  conduct  an unannounced  on-site  investigation of  a  hospital within 60
calendar days after receiving a valid complaint against the hospital for violating a provision ofORS 441.152 to 441.177. A complaint is valid when an allegation, if assumed to be true, wouldviolate a requirement of ORS 441.152 to 441.177.
(2) During an investigation,  the Authority  shall review any  hospital record and conduct  any
interview or site visit that is necessary to determine whether the hospital has violated a provisionof ORS 441.152 to 441.177.
(3) In conducting an investigation, the Authority may:
(a) Review any documentation that may be relevant to the complaint, including patient records;
and
(b) Interview any person who may have information relevant to the complaint, including patients
and family members.
(4) In reviewing information collected during an investigation, the Authority shall consider:(a) The amount and strength of  objective evidence, if  any, that substantiates or refutes the
complaint; and
(b) The number and credibility of witnesses, if any, who attest to or refute an alleged violation.(5)  Following  an  investigation,  the  Authority  shall  issue  a  written  investigation  report  that
communicates  the  results  of  the  investigation  no  more  than  30  business  days  after  theinvestigation closes. This investigation report:
(a) Shall be issued to the hospital and both co-chairs of the hospital nurse staffing committee; and(b)  May  include  a  notice  of  civil  penalties  that  complies  with  ORS  441.175  and  OAR
333-501-0045.
(6) If the investigation report identifies any area of noncompliance, the hospital shall submit a
written plan to correct each identified deficiency. This plan:
(a) Shall be called the plan of correction;(b) Shall be submitted no more than 30 business days after receiving the Authority’s investigation
report; and
(c) Shall be evaluated by the Authority for sufficiency.
(7) No more than 30 business days after receipt of the hospital’s plan of correction, the Authority
shall issue a written determination that communicates whether the plan of correction is sufficient.This determination:
(a) Shall be issued to the hospital and both co-chairs of the hospital nurse staffing committee; and(b) Shall require the hospital to either:(A) Revise and resubmit the rejected plan of correction no more than 30 business days after
receiving the Authority’s determination that the plan is insufficient; or
(B) Implement the approved plan of correction no more than 45 business days after receiving the
Authority’s determination that the plan is sufficient.
(8) Following  the  approval of  the  plan of  correction,  the  Authority  shall conduct  a  second
investigation of  the hospital to  verify that the hospital has implemented the approved plan ofcorrection. This investigation shall be conducted within 60 business days of the plan of correctionapproval date.
(9) The identity of an individual providing evidence during an investigation will be kept confidential
to the extent permitted by law.
Stat. Auth.: ORS 413.042, 441.025, 441.057, 441.171 & 441.175Stats. Implemented: ORS 441.057 & 441.171Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10; PH 26-2010,
f. 12-14-10, cert. ef. 12-15-10; PH 22-2016, f. & cert. ef. 7-1-16Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
91 of 100 8/11/2016 2:13 P M333-501-0045
Civil Penalties for Violations of Nurse Staffing Laws
(1) For the purposes of this rule, “safe patient care” has the meaning given to the term in OAR
333-510-0002.
(2) The Authority may impose civil penalties for a violation of any provision of ORS 441.152 to
441.177 and 441.185 if there is a reasonable belief that safe patient care has been or may benegatively impacted.
(3)  Each violation of  the  written hospital-wide  staffing  plan shall be  considered  a  separate
violation.
(4) If imposed, the Authority will issue civil penalties in accordance with Table 1 of this rule.
(5) In determining whether to issue a civil penalty, the Authority will consider all relevant evidence
including, but not limited to, witness testimony, written documents and observations.
(6) A civil penalty imposed under this rule shall comply with ORS 183.745.(7) The Authority shall maintain for public inspection records of any civil penalties imposed on
hospitals penalized under this rule.
[ED. NOTE: Tables referenced are available from the agency.]
Stat. Auth.: ORS 413.042, 441.175 & 441.185
Stats. Implemented: ORS 441.175 & 441.185Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10; PH 26-2010,
f. 12-14-10, cert. ef. 12-15-10; PH 22-2016, f. & cert. ef. 7-1-16
333-510-0002
Definitions
As used in OAR chapter 333, division 510, the following definitions apply:(1) “Direct Care Registered Nurse” means a nurse who is routinely assigned to a patient care unit,
who  is replaced for scheduled and unscheduled absences and includes charge nurses if  thecharge nurse is not management services.
(2) “Direct Care Staff” means registered nurses, licensed practical nurses and certified nursing
assistants that are routinely assigned to patient care units and are replaced for scheduled orunscheduled absences.
(3) “Direct Care Staff Member” means an individual who is a direct care registered nurse, licensed
practical nurse or certified nursing assistant who is routinely assigned to a patient care unit and isreplaced for a scheduled or unscheduled absences.
(4) “Epidemic” means the occurrence of a group of similar conditions of public health importance
in a community or region that are in excess of normal expectancy and that are from a common or
propagated source.
(5) “Evidence Based Standards” means standards that have been scientifically developed, are
based on current literature, and are driven by consensus.
(6) “Hospital” means a hospital as described in ORS 442.015 and an acute inpatient care facility
as defined in ORS 442.470.
(7) “Mandatory Overtime” is any time that exceeds those time limits specified in ORS 441.166
unless the nursing staff member voluntarily chooses to work overtime.
(8) “Nurse Manager” means a registered nurse who has administrative responsibility 24 hours a
day, 7 days a week for a patient care unit, units or hospital and who is not replaced for short-termscheduled or unscheduled absences.
(9) “Nursing care intensity” means the level of patient need for nursing care as determined by the
nursing assessment.
(10) “Nursing  staff”  means  registered  nurses,  licensed practical nurses  and  certified  nursing
assistants.
(11) “Nursing staff  member” means an individual who  is a registered nurse, licensed practical
nurse or a certified nursing assistant.Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
92 of 100 8/11/2016 2:13 P M(12) “On Call” means a scheduled state of  availability to  return to  duty, work-ready, within a
specified period of time.
(13) “On Call Nursing Staff” means individual nursing staff members or nursing service agencies
maintained by a hospital that are available and willing to cover nursing staff  shortages due tounexpected nursing staff absences or unanticipated increased nursing service needs.
(14) “Patient acuity” means the complexity of patient care needs requiring the skill and care of
nursing staff.
(15) “Potential Harm” or “At Risk of  Harm” means that an unstable patient will be left without
adequate care for an unacceptable period of time if the assigned nursing staff member leaves theassignment or transfers care to another nursing staff member.
(16) “Quorum” means that a majority, or one-half plus one, of the staffing committee members are
present during a staffing committee meeting.
(17) “Safe Patient Care” means nursing care that is provided appropriately, in a timely manner,
and meets the patient’s health care needs. The following factors may be, but are not in all
circumstances, evidence of unsafe patient care:
(a) A failure to implement the written nurse staffing plan;(b) A failure to comply with the patient care plan;(c) An error that has a negative impact on the patient;(d) A patient report that his or her nursing care needs have not been met;(e) A medication not given as scheduled;
(f) The nursing preparation for a procedure that was not accomplished on time;
(g) A nursing staff member who was practicing outside his or her authorized scope of practice;(h)  Daily  unit-level staffing  that  does  not  include  coverage  for  all known patients,  taking  into
account the turnover of patients;
(i) The skill mix of employees and the relationship of the skill mix to patient acuity and nursing care
intensity of the workload is insufficient to meet patient needs; or
(j) An unreasonable delay in responding to a request for nursing care made by a patient or made
on behalf of a patient by his or her family member.
(18) “Staffing Committee” means the hospital nurse staffing committee.(19) “Staffing Plan” means the written hospital-wide staffing plan for nursing services developed
by the hospital nurse staffing committee.
(20) “Standby” means a scheduled state of  availability to  return to  duty, work-ready within a
specified period of time.
(21) “Waiver” means a variance to the hospital-wide staffing plan requirements as described in
ORS 441.164.
Stat. Auth.: ORS 413.042 & 441.151 – 441.177Stats. Implemented: ORS 441.165, 441.166 & 441.179Hist.: PH 21-2006, f. & cert. ef. 10-6-06; PH 11-2009, f. & cert. ef. 10-1-09; PH 22-2016, f. & cert.
ef. 7-1-16
333-510-0045
Nurse Staffing Posting and Record Requirements
(1) On each hospital unit, a hospital shall post a complaint notice that:(a) Summarizes the provisions of ORS 441.152 to 441.177;(b) Is clearly visible to the public; and
(c)  Includes  the  Authority’s  complaint  reporting  phone  number,  electronic  mail address  and
website address.
(2) A hospital shall also post an anti-retaliation notice on the premises that:(a) Summarizes the provisions of ORS 441.181, 441.183, 441.184 and 441.192;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
93 of 100 8/11/2016 2:13 P M(b) Is clearly visible; and
(c)  Is  posted  where  notices  to  employees  and  applicants  for  employment  are  customarily
displayed.
(3) A hospital shall keep and maintain all records necessary to demonstrate compliance with ORS
441.152 to 441.177. These records shall:
(a) Be maintained for no fewer than three years;
(b) Be promptly provided to the Authority upon request; and
(c) Include, at minimum:(A) The staffing plan;(B) The hospital nurse staffing committee charter;(C) Staffing committee meeting minutes;(D) Documentation showing how all members of the staffing committee were selected;(E) All complaints filed with the staffing committee;
(F) Personnel files for all nursing staff  positions that include, at minimum, job descriptions,
required licensure and specialized qualifications and competencies required for the individual’sassigned nurse specialty or unit;
(G) Documentation showing work schedules for nursing staff in each hospital nurse specialty or
unit;
(H) Documentation showing actual hours worked by all nursing staff;(I) Documentation showing all work schedule variances that resulted in the use of replacement
nursing staff;
(J) Documentation showing how many on-call hours, if  any, required nursing staff  to  be on the
hospital premises;
(K) Documentation showing how many required meeting, education and training hours, if  any,
were required of nursing staff;
(L) The hospital’s mandatory overtime policy and procedure;(M) Documentation showing how many, if any, overtime hours were worked by nursing staff;
(N) Documentation of all waiver requests, if any, submitted to the Authority;
(O) Documentation showing how many, if any, additional hours were worked due to emergency
circumstances and the nature of those circumstances;
(P) The list of on-call nursing staff used to obtain replacement nursing staff;(Q) Documentation showing how and when the hospital updates its list of on-call staff used to
obtain replacement nursing staff and how the hospital determines eligibility to remain on the list;
(R) Documentation showing the hospital’s procedures for obtaining replacement nursing staff,
including efforts made to obtain replacement staff;
(S) Documentation showing the hospital’s actual efforts to seek replacement staff when needed;(T) Documentation showing each actual instance in which the hospital implemented the policy
described in OAR 333-510-0110(2)(g) to initiate limitations on admission or diversion of patientsto another hospital; and
(U) All staffing committee reports filed with the hospital administration following a review of the
staffing plan.
Stat. Auth.: ORS 413.042, 441.155, 441.169, 441.173 & 441.185Stats. Implemented: ORS 441.155, 441.169, 441.173 & 441.185Hist.: OHD 2-2000, f. & cert. ef. 2-15-00; OHD 3-2001, f. & cert. ef. 3-16-01; OHD 20-2002, f. &
cert. ef. 12-10-02; PH 22-2005(Temp), f. 12-30-05, cert. ef. 1-1-06 thru 6-29-06; PH 21-2006, f. &cert. ef. 10-6-06; PH 11-2009, f. & cert. ef. 10-1-09; PH 11-2009, f. & cert. ef. 10-1-09; PH22-2016, f. & cert. ef. 7-1-16
333-510-0105Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
94 of 100 8/11/2016 2:13 P MNurse Staffing Committee Requirement
(1) Each hospital shall establish and maintain a hospital nurse staffing committee. The staffing
committee shall develop a written hospital-wide staffing plan for nursing services in accordancewith ORS 441.155 and OAR chapter 333, division 510 rules. In developing the staffing plan, thestaffing committee’s primary goal shall be to ensure that the hospital is adequately staffed to meet
the health care needs of its patients.
(2) The staffing committee shall meet:(a) At least once every three months; and(b) At any time and place specified by either co-chair of the staffing committee.(3) The hospital shall release a member of the staffing committee from his or her assignment to
attend committee meetings and provide paid time for this purpose.
(4) The staffing committee shall be comprised of an equal number of hospital nurse managers
and direct care staff. Direct care staff members shall be selected as follows:
(a) The staffing committee shall include at least one direct care registered nurse from each
hospital nurse specialty or unit as the specialty or unit is defined by the hospital to represent thatspecialty or unit;
(b) In addition to the direct care registered nurses described in subsection (a) of this section there
must be one position on the staffing committee that is filled by a direct care staff member who isnot a registered nurse and whose services are covered by the staffing plan;
(c) If the direct care registered nurses working at the hospital are represented under a collective
bargaining  agreement,  the  bargaining  unit  shall  coordinate  voting  to  allow  the  direct  careregistered nurses who work at the hospital to select each direct care registered nurse on thestaffing committee;
(d) If  the direct care registered nurses  working at the hospital are not  represented under a
collective bargaining agreement, the direct care registered nurses belonging to  each hospitalnurse specialty or unit shall select the direct care registered nurse to represent it on the staffing
committee; and
(e) If the position that must be filled by a direct care staff member who is not a registered nurse
and whose services are covered by the staffing plan is represented under a collective bargainingagreement, the bargaining unit shall coordinate voting to allow the direct care staff members whoare not registered nurses to select the direct care staff member who is not a registered nurse torepresent them on the staffing committee.
(f) If the position that must be filled by a direct care staff member who is not a registered nurse
and whose  services  are  covered by  the staffing  plan is  not  represented  under  a collective
bargaining agreement, the direct care staff members who are not registered nurses shall select
the direct care staff  member who is not a registered nurse to represent them on the staffingcommittee.
(5) The staffing committee shall have two  co-chairs. One co-chair must be a hospital nurse
manager  elected  by  a  majority  of  the  staffing  committee  members  who  are  hospital nursemanagers. The other co-chair must be a direct care registered nurse elected by a majority of thestaffing committee members who are direct care staff.
(6) The staffing committee must develop a written charter that documents the policies and
procedures of the staffing committee. At minimum, the charter must include:
(a) How meetings are scheduled;(b) How members are notified of meetings;(c) How agendas are determined;(d) How input from hospital nurse specialty or unit staff is submitted;(e) Who may participate in decision-making;
(f) How decisions are made; and
(g) How the staffing committee shall monitor, evaluate and modify the staffing plan over time.(7) Staffing committee meetings must be conducted as follows:(a) A meeting may not be conducted unless a quorum of staffing committee members is present;(b) Except as set forth in subsection (c) of this section, a meeting must be open to all hospitalOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
95 of 100 8/11/2016 2:13 P Mnursing staff as observers and to any other individual as either observer or presenter by invitation
of either co-chair of the staffing committee;
(c) Either co-chair of the staffing committee may temporarily exclude all non-members from a
meeting during staffing committee deliberations and voting; and
(d) Each staffing committee decision must be made by majority vote; however, if  a quorum
consists of an unequal number of hospital nurse managers and direct care staff, only an equalnumber of hospital nurse managers and direct care staff may vote.
(8) The staffing committee must  document  meeting proceedings  by  keeping written meeting
minutes that include, but are not limited to, the following information:
(a) The name and position of each staffing committee member in attendance;(b) The name and position of each observer or presenter in attendance;(c) Motions made;(d) Outcomes of votes taken;
(e) A summary of staffing committee discussions; and
(f) Instances in which non-members have been excluded from staffing committee meetings.(9) The staffing committee shall approve meeting minutes prior to  or during the next staffing
committee meeting.
(10) The staffing committee shall provide meeting minutes to  hospital nursing staff  and other
hospital staff  upon request  no  more  than 30  calendar  days  after  the  meeting  minutes  areapproved by the staffing committee.
Stat. Auth.: ORS 413.042, 441.151 & 441.154
Stats. Implemented: ORS 441.154Hist.: PH 22-2016, f. & cert. ef. 7-1-16
333-510-0110
Nurse Staffing Plan Requirements
(1) Each hospital shall implement a written hospital-wide staffing plan for nursing services that is
developed and approved by the hospital nurse staffing committee established in accordance withORS 441.154 and OAR chapter 333 division 510 rules.
(2) The staffing plan:(a) Must be based on the specialized qualifications and competencies of the nursing staff and
provide for the skill mix and level of competency necessary to ensure that the hospital is staffed
to meet the health care needs of patients;
(b)  Must  be  based  on a  measurement  of  hospital  unit  activity  that  quantifies  the  rate  of
admissions, discharges and transfers for each hospital unit and the time required for a direct careregistered nurse belonging to a hospital unit to complete admissions, discharges and transfers forthat hospital unit;
(c) Must be based on total diagnoses for each hospital unit and the nursing staff  required to
manage that set of diagnoses;
(d)  Must  be  consistent  with nationally  recognized  evidence-based  standards  and  guidelines
established by  professional nursing specialty  organizations  such as, but not limited to: TheAmerican Association of Critical Care Nurses, American Operating Room Nurses (AORN), orAmerican Society of Peri-Anesthesia Nurses (ASPAN);
(e) Must recognize differences in patient acuity and nursing care intensity;(f)  Must  establish minimum  numbers  of  nursing  staff,  including  licensed  practical nurses  and
certified  nursing  assistants,  required  on specified  shifts,  provided  that  no  fewer  than one
registered nurse and one other nursing staff member is on duty in a unit when a patient is present;
(g)  Must  include  a  formal process  for  evaluating  and  initiating  limitations  on admission or
diversion of patients to another hospital when, in the judgment of a direct care registered nurse ora nurse manager, there is an inability to meet patient care needs or a risk of harm to patients;
(h) Must consider tasks not related to providing direct care, including meal breaks and rest breaks;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
96 of 100 8/11/2016 2:13 P M(i) May not base nursing staff requirements solely on external benchmarking data;
(j) May not be used by a hospital to impose upon unionized nursing staff any changes in wages,
hours or other terms and conditions of  employment unless the hospital first provides notice toand, upon request, bargains with the union; and
(k) May not create, preempt or modify a collective bargaining agreement or require parties to an
agreement to bargain over the staffing plan while a collective bargaining agreement is in effect.
Stat. Auth.: ORS 413.042 & 441.155
Stats. Implemented: ORS 441.155
Hist.: PH 22-2016, f. & cert. ef. 7-1-16
333-510-0115
Nurse Staffing Plan Review Requirement
(1) The staffing committee shall:(a) Review the staffing plan at least once per year; and(b) At any other time specified by either co-chair of the staffing committee.(2) In reviewing the staffing plan, the staffing committee shall consider:(a) Patient outcomes;
(b) Complaints regarding staffing, including complaints about a delay in direct care nursing or an
absence of direct care nursing;
(c)  The  number  of  hours  of  nursing  care  provided  through a  hospital unit  compared  with the
number of patients served by the hospital unit during a 24-hour period;
(d) The aggregate hours of mandatory overtime worked by nursing staff;(e) The aggregate hours of voluntary overtime worked by nursing staff;(f) The percentage of shifts for each hospital unit for which staffing differed from what is required
by the staffing plan;
(g) Any other matter determined by the committee to be necessary to ensure that the hospital is
staffed to meet the health care needs of patients; and
(h) Any report filed by a nursing staff member stating the nursing staff member’s belief that the
hospital unit engaged in a pattern of  requiring direct care nursing staff  to  work overtime fornonemergency care.
(3) Following its review of the staffing plan, the staffing committee shall issue a written report to
the hospital that indicates whether the staffing plan ensures that the hospital is adequately staffed
and meets the health care needs of patients. If the report indicates that it does not, the staffingcommittee shall modify the staffing plan as necessary to accomplish this goal.
Stat. Auth.: ORS 413.042 & 441.156Stats. Implemented: ORS 441.156Hist.: PH 22-2016, f. & cert. ef. 7-1-16
333-510-0120
Nurse Staffing Plan Mediation
(1) If the staffing committee is unable to reach an agreement on the staffing plan, either co-chair
of the staffing committee may invoke a waiting period of 30 business days.
(a) During the 30-day waiting period, the staffing committee shall continue to develop the staffing
plan; and
(b) The hospital shall promptly respond to any reasonable requests for data that is related to the
impasse and is submitted by either co-chair of the staffing committee.
(2) If at the end of the 30-day waiting period, the staffing committee remains unable to reach an
agreement on the staffing plan, one of the staffing committee co-chairs shall notify the Authorityof the impasse. This notification shall include:
(a) Documentation that the staffing committee voted on the provision or provisions in questionOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
97 of 100 8/11/2016 2:13 P Mand a deadlock resulted;
(b) Documentation that either co-chair of the staffing committee formally invoked a 30-day waiting
period;
(c) Documentation that during the 30-day waiting period, the staffing committee continued to
develop the staffing plan including documentation of options the staffing committee consideredafter invoking the 30-day waiting period;
(d) Documentation of any reasonable requests for data submitted to the hospital by either staffing
committee co-chair and the hospital’s response, if any; and
(e) Documentation that the staffing committee voted on the provision or provisions in question
again after the 30-day waiting period formally ended and another deadlock resulted.
(3) No more than 15 business days after receiving notice of an impasse, the Authority shall assign
the staffing committee a mediator to assist the staffing committee in reaching an agreement onthe staffing plan.
(a) Mediation shall be consistent with requirements for implementing and reviewing staffing plans
set forth in ORS 441.155 and 441.156 and OAR chapter 333 division 510 rules; and
(b) Mediation shall be provided for no more than 90 calendar days.(4) The Authority may impose civil monetary penalties against a hospital, if the staffing committee
is unable to reach an agreement on the staffing plan after 90 days of mediation.
Stat. Auth.: ORS 413.042, 441.154 & 441.175Stats. Implemented: ORS 441.154
Hist.: PH 22-2016, f. & cert. ef. 7-1-16
333-510-0125Replacement Nurse Staffing Requirements
(1) A  hospital must  maintain and post or publish a list of  on-call nursing staff  that may  be
contacted to provide qualified replacement or additional nursing staff in the event of a vacancy orunexpected shortage. This list must:
(a) Provide for sufficient replacement nursing staff on a regular basis; and(b) Be available to the individual who is responsible for obtaining replacement staff during each
shift.
(2) When developing and maintaining the on-call list, the hospital must explore all reasonable
options for identifying local replacement staff and these efforts must be documented.
(3) When a hospital learns about the need for replacement nursing staff, the hospital must make
every reasonable effort to obtain adequate voluntary replacement nursing staff for unfilled hoursor shifts before requiring a nursing staff member to work overtime and these efforts must bedocumented. Reasonable efforts include, but are not limited to:
(a) The hospital seeking replacement nursing staff at the time the vacancy is known; and(b) The hospital contacting all available resources on its list of on-call nursing staff as described in
this rule.
Stat. Auth.: ORS 413.042, 441.155 & 441.166
Stats. Implemented: ORS 441.155 & 441.166Hist.: PH 22-2016, f. & cert. ef. 7-1-16
333-510-0130
Nursing Staff Member Overtime
(1) For purposes of this rule “require” means hours worked as a condition of employment whether
as a result of a previously scheduled shift or hours actually worked during time spent on call or onstandby.
(2) A hospital may not require a nursing staff member to work:
(a) Beyond the agreed-upon and prearranged shift, regardless of the length of the shift;Oregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
98 of 100 8/11/2016 2:13 P M(b) More than 48 hours in any hospital-defined work week;
(c) More than 12 hours in a 24-hour period; or(d) During the 10-hour period immediately following the 12th hour worked during a 24-hour period.
This work period begins when the nursing staff member begins a shift.
(3) Nothing in this rule precludes a nursing staff member from volunteering to work overtime.(4) A hospital may require an additional hour of work beyond the hours authorized in section (2) of
this rule if:
(a) A staff vacancy for the next shift becomes known at the end of the current shift; or(b) There is a potential harm to  an assigned patient if  the nursing staff  member leaves the
assignment or transfers care to another nursing staff member.
(5) Each hospital must have a policy and procedure in place to ensure, at minimum, that:(a) Mandatory overtime, when required, is documented in writing;(b) Mandatory overtime policies and procedures are clearly written, provided to all new nursing
staff and readily available to all nursing staff;
(c) Time spent by the nursing staff member in required meetings or receiving education or training
will be included as hours worked for the purpose of section (2) of this rule;
(d) Time spen t on call or on stan dby wh en th e n u rsin g staff member is requ ired to be at th e
hospital will be included as hours worked for the purpose of section (2) of this rule; and
(e) Time spent on call or on standby when the nursing staff member is not required to be at the
hospital will not be included as hours worked for the purpose of section (2) of this rule.
(6) If a nursing staff member believes that a hospital unit is engaging in a pattern of requiring
direct care nursing staff to work overtime for nonemergency care, the nursing staff member mayreport  that  information to  the staffing  committee.  The  staffing committee  shall consider theinformation when reviewing the staffing plan as described in OAR 333-510-0115.
(7) The provisions of sections (2) through (5) of this rule do not apply to nursing staff needs:(a) In the event of a national or state emergency or circumstances requiring the implementation of
a facility disaster plan; or
(b) In emergency circumstances that include:
(A) Sudden and unforeseen adverse weather conditions;(B) An infectious disease epidemic suffered by hospital staff;(C)  Any  unforeseen  event  preventing  replacement  staff  from  approaching  or  entering  the
premises; or
(D) Unplanned direct care staff vacancies of 20% or more of the nursing staff for the next shift
hospital-wide at the Oregon State Hospital if, based on the patient census, the Oregon State
Hospital determines the number of direct care staff available hospital-wide cannot ensure patient
safety.
(8) Nothing in section (6) of this rule relieves the Oregon State Hospital from contacting voluntary
replacement staff as described in OAR 333-510-0125 and documenting these contacts.
(9) A registered nurse at a hospital may not place a patient at risk of harm by leaving a patient
care assignment during an agreed upon scheduled shift or an agreed-upon extended shift withoutauthorization from the appropriate supervisory personnel as required by the Oregon State Board
of Nursing OAR, chapter 851.
(10) Until the Authority defines “other nursing staff” as that term is described in ORS 441.166(1),
this rule applies only to “nursing staff member” as that term is defined in these rules.
Stat. Auth.: ORS 413.042, 441.166 & 441.168Stats. Implemented: ORS 441.155 & 441.165Hist.: PH 22-2016, f. & cert. ef. 7-1-16
333-510-0135
Nurse Staffing Plan WaiverOregon Secretary of State Archives Division http://arcweb.sos.state.or.us/pages/rules/bulletin/0816_bulletin/0816_ch...
99 of 100 8/11/2016 2:13 P M(1) At a hospital’s request, the Authority may waive any staffing plan requirement set forth in ORS
441.155 provided that a waiver is necessary to ensure that the hospital is staffed to meet thehealth care needs of its patients.
(2) All requests for a waiver must:(a) Be submitted to the Authority in writing;(b) State the reason or reasons for which the hospital is seeking the waiver;
(c) Explain how the waiver is necessary for the hospital to meet patient health care needs; and
(d) Include verification that the hospital notified the staffing committee of the request for a waiver
prior to its submission.
Stat. Auth.: ORS 413.042 & 441.165Stats. Implemented: ORS 441.155 & 441.165Hist.: PH 22-2016, f. & cert. ef. 7-1-16
333-510-0140
Nurse Staffing Plan During an Emergency
(1) A hospital is not required to follow the staffing plan developed and approved by the staffing
committee in the event of:
(a) A national or state emergency requiring the implementation of a facility disaster plan;
(b) Sudden and unforeseen adverse weather conditions; or(c) An infectious disease epidemic suffered by hospital staff.(2) In the event of an emergency circumstance not described in section (1) of this rule, either
co-chair of the staffing committee may specify a time and place to meet to review and potentiallymodify the staffing plan in response to the emergency circumstance.
Stat. Auth.: ORS 413.042 & 441.165
Stats. Implemented: ORS 441.155 & 441.165
Hist.: PH 22-2016, f. & cert. ef. 7-1-16
Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official,
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Cumulative Index  found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2015.
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