Arkansas Medical Marijuana Rule

ARKANSAS STATE BOARD OF HEALTH

DEPARTMENT OF HEALTH

RULES AND REGULATIONS GOVERNING MEDICAL MARIJUANA

REGISTRATION, TESTING, AND LABELING IN ARKANSAS

Promulgated Under the Authority of

Amendment No. 98 of the Constitution of the State of Arkansas of 1874

The Medical Marijuana Amendment of 2016

Effective September 11, 2017

Table of Contents

SECTION I. DEPARTMENT .......................................................................................1

SECTION II. SCOPE AND PURPOSE ..........................................................................1

SECTION III. DEFINITIONS .........................................................................................1

SECTION IV. REGISTRY IDENTIFICATION CARDS.................................................4

SECTION V. LABELING ..............................................................................................8

SECTION VI. TESTING STANDARDS FOR USABLE MARIJUANA ....................... 12

SECTION VII. TESTING REQUIREMENTS FOR CONCENTRATES AND

EXTRACTS ............................................................................................................... 13

SECTION VIII. BATCH REQUIREMENTS ................................................................... 14

SECTION IX. SAMPLING AND SAMPLE SIZE ......................................................... 15

SECTION X. SAMPLING PERSONNEL REQUIREMENTS; SAMPLING

RECORDKEEPING ............................................................................................................... 15

SECTION XI. CULTIVATION FACILITY OR DISPENSARY REQUIREMENTS FOR

LABELING AND RECORDKEEPING .................................................................................... 16

SECTION XII. STANDARDS FOR TESTING MICROBIOLOGICAL

CONTAMINANTS ............................................................................................................... 17

SECTION XIII. STANDARDS FOR TESTING PESTICIDES ........................................ 17

SECTION XIV. STANDARDS FOR TESTING SOLVENTS .......................................... 17

SECTION XV. STANDARDS FOR TESTING WATER ACTIVITY AND MOISTURE

CONTENT ............................................................................................................... 18

SECTION XVI. STANDARDS FOR THC AND CBD TESTING.................................... 18

SECTION XVII. STANDARDS FOR TESTING FOR HEAVY METALS ....................... 18

SECTION XVIII. FAILED TEST SAMPLES ..................................................................... 19

SECTION XIX. TENTATIVE IDENTIFICATION OF COMPOUNDS ........................... 21

SECTION XX. AUDIT AND RANDOM TESTING....................................................... 21

SECTION XXI. TEMPORARY CULTIVATION FACILITY OR DISPENSARY

PESTICIDE TESTING REQUIREMENTS ............................................................................... 21

SECTION XXII. PETITIONS TO ADD MEDICAL CONDITIONS OR TREATMENTS 22

APPENDIX A ............................................................................................................... 25

APPENDIX B ............................................................................................................... 30

RULES AND REGULATIONS GOVERNING MEDICAL MARIJUANA

REGISTRATION, LABELING, AND TESTING IN ARKANSAS

SECTION I. DEPARTMENT

These Rules and Regulations Governing Medical Marijuana Registration, Testing, and Labeling

in Arkansas are duly adopted and promulgated by the Arkansas State Board of Health pursuant

to the Department expressly conferred by the Laws of the State of Arkansas including, without

limitation, Amendment No. 98 of the Constitution of the State of Arkansas of 1874, The Medical

Marijuana Amendment of 2016.

SECTION II. SCOPE AND PURPOSE

These Rules govern the application for and renewal of registry identification cards for qualifying

patients and designated caregivers. These Rules also establish labeling and testing standards for

marijuana distributed under the Medical Marijuana Amendment, and how medical conditions

may be added to the list of qualifying conditions.

SECTION III. DEFINITIONS

(1) “Acquire” or “Acquisition” means coming to possess marijuana by means of any legal

source herein authorized, not from an unauthorized source, and in accordance with the

Amendment and any rules promulgated under the Amendment;

(2) "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.

(3) “Amendment” means the Arkansas Medical Marijuana Amendment of 2016.

(4) “Approved Laboratory” means a laboratory that is accredited by the National Institute on

Drug Abuse (NIDA), the National Environmental Laboratory Accreditation Conference

(NELAC), the International Organization for Standardization (ISO) or similar accrediting entity

as determined by the Department, and that has been approved by the Department specifically for

the testing of usable marijuana.

(5) “Assist” or “assisting” means helping a qualifying patient make medical use of marijuana

by enabling the medical use by any means authorized under the Amendment.

(6) “Batch” means, with regard to usable marijuana, a homogenous, identified quantity of

usable marijuana, no greater than ten (10) pounds, that is harvested during a specified time

period from a specified cultivation area, and with regard to oils vapors and waxes derived from

usable marijuana, means an identified quantity that is uniform, that is intended to meet

specifications for identity, strength, and composition, and that is manufactured, packaged and

labeled during a specified time period according to a single manufacturing, packaging and

labeling protocol.

(7) "CBD" means cannabidiol, Chemical Abstracts Service Number 13956-29-1.

(8) "CBDA" means cannabidiolic acid, Chemical Abstracts Service Number 1244-58-2.

(9) “Cardholder” means a qualifying patient or a designated caregiver;

(10) “Cultivation facility” means an entity that:

(a) Has been licensed by the Medical Marijuana Commission;

(b) Cultivates, prepares, manufactures, processes, packages, sells to and delivers

usable marijuana to a dispensary;

(11)(a) “Designated caregiver” means a person who is at least twenty-one (21) years of age, has

not been convicted of an excluded felony offense, has agreed to assist a physically disabled

qualifying patient with the medical use of marijuana, and who has registered with the

Department of Health pursuant to the requirements of the Amendment and these Rules.

(b) Designated caregiver includes, without limitation, a parent:

(i) Of a qualifying patient who is under the age of eighteen (18); and

(ii) Required to register as a designated caregiver under the Amendment.

(12) “Dispensary” means an entity that has been licensed by the Medical Marijuana

Department pursuant to the requirements of the Amendment.

(13) “Division” means the Alcoholic Beverage Control Division.

(14) “Excluded felony offense” means:

(a)(i) A felony offense as determined by the jurisdiction where the felony offense

occurred. The Department of Health shall determine whether an offense is a felony offense

based upon a review of the relevant court records concerning the conviction for the offense.

(ii) An offense that has been sealed by a court or for which a pardon has been

granted is not considered an excluded felony offense; or

(b) A violation of a state or federal controlled-substance law that was classified as a

felony in the jurisdiction where the person was convicted, but not including:

(i) An offense for which the sentence, including any term of probation,

incarceration, or supervised release, was completed ten (10) or more years earlier; or

(ii) An offense that has been sealed by a court or for which a pardon has been

granted.

(15) "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.

(16) “Lot” mans an identified portion of a batch, that is uniform and that is intended to meet

specifications for identity, strength, and composition; or in the case of a vapor, oil, or wax

derived from usable marijuana, an identified quantity produced in a specified period of time in a

manner that is uniform and that is intended to meet specifications for identity, strength, and

composition.

(17) “Commission” means the Medical Marijuana Commission.

(18) “Medical use” means the acquisition, possession, use, delivery, transfer or transportation

of marijuana or paraphernalia relating to the administration of marijuana to treat or alleviate a

qualifying patient’s qualifying medical condition or symptoms associated with the qualifying

patient’s qualifying medical condition.

(19) “Physician” means a doctor of medicine or a doctor of osteopathic medicine who holds a

valid, unrestricted, and existing license to practice in the state of Arkansas and has been issued a

current and active registration from the United States Drug Enforcement Administration to

prescribe controlled substances;

(20) "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

or transfer.

(21) "Process lot" means 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 from the same batch of batches harvested marijuana.

(22) "Proper identification" means a motor vehicle operator's license or other official state-

issued identification of the purchaser that contains a photograph of the purchaser, and includes

the residential or mailing address of the purchaser, other than a post office box number;

(23) “Qualifying medical condition” means one or more of the following:

(a) Cancer, glaucoma, positive status for human immunodeficiency virus/acquired

immune deficiency syndrome, heptatits C, amyotrophic lateral sclerosis, Tourette’s syndrome,

Crohn’s disease, ulcerative colitis, post-traumatic stress disorder, severe arthritis, fibromyalgia,

Alzheimer’s disease, or the treatment of these conditions;

(b) A chronic or debilitating disease or medical condition or its treatment that

produces one (1) or more of the following: cachexia or wasting syndrome; peripheral

neuropathy; intractable pain, which is pain that has not responded to ordinary medications,

treatment or surgical measures for more than six (6) months; severe nausea; seizures, including

without limitation those characteristic of epilepsy; or severe and persistent muscle spasms,

including, without limitation those characteristic of multiple sclerosis; and

pursuant to these Rules and the Amendment.

(24) “Qualifying patient” means a person who has been diagnosed by a physician as having a

qualifying medical condition and who has registered with the Department in accordance with

these Rules and the Amendment.

(25) "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 Appendix A, §1(A).

(26) "Relative standard deviation" or "RSD" means the standard deviation expressed as a

percentage of the mean recovery as calculated under Appendix A, §1(A).

(27) “Registry identification card” means a document issued by the Department that identifies

a person as a qualifying patient or a designated caregiver.

(28) “Sealed” means expunge, remove, sequester, and treat as confidential the record or

records of a felony offense;

(29) “Segregate” means to separate and withhold from use or sale batches, lots, or usable

marijuana in order to first determine its suitability for use through testing by an approved

laboratory.

(30) ‘Testing” means the process and procedures provided by an approved laboratory for

testing of usable marijuana, consistent with provisions of this rule.

(31) “Tetrahydrocannabinol (THC)” is a cannabinoid that is the primary psychoactive

ingredient in usable marijuana.

(32) "THCA" means tetrahydrocannabinolic acid, Chemical Abstracts Service Number 23978-

85-0.

(33) "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.

The NELAC Institute standards adopted by NELAC), which describe the elements of laboratory

accreditation developed and established by the consensus principles of TNI and that meet the

approval requirements of TNI procedures and policies.

(35) "Universal symbol" means the image, established by the Department and made available

to licensees and registrants, indicating the container contains marijuana.

(36)(1) “Usable marijuana” means the stalks, seeds, roots, dried leaves, flowers, oils, vapors,

waxes, and other portions of the marijuana plant and any mixture or preparation thereof.

(2) Usable marijuana does not include the weight of any ingredients other than

marijuana that are combined with marijuana and prepared for consumption as food or drink.

(37) “Visiting qualifying patient” means a patient with a qualifying medical condition who is

not a resident of Arkansas or who has been a resident of Arkansas for less than thirty (30) days

and who is in actual possession of a registry identification card or its equivalent that is issued

under the laws of another state, district, territory, commonwealth, or insular possession of the

United States and pertains to a qualifying medical condition under the Amendment; and

(38)(1) "Written certification" means a document signed by a physician stating that in the

physician's professional opinion, after having completed an assessment of the qualifying patient's

medical history and current medical condition made in the course of a physician-patient

relationship, the qualifying patient has a qualifying medical condition.

(2) A written certification shall specify the qualifying patient's qualifying medical

condition, which also shall be noted in the physician's records.

(3) A physician shall not issue a written certificate to a patient based on an assessment

performed through telemedicine.

(4) A written certification is not a medical prescription

SECTION IV. REGISTRY IDENTIFICATION CARDS

(A) Qualifying Patients. The Department shall issue registry identification cards to qualifying

patients who submit the following:

(1) An application for a qualifying patient registry identification card that must

include the following:

(a) The Qualifying Patient’s name and date of birth;

(b) The Qualifying patient’s address, unless the qualifying patient is

homeless;

registration number of the physician providing the written certification;

(d) The name, address, and phone number of the qualifying patient’s

designated caregiver, if applicable;

(e) A signed statement by the qualifying patient that he or she will not divert

marijuana to anyone who is not allowed to possess it under the Amendment; and

(f) A copy of a driver’s license or identification card issued by the State of

Arkansas.

(2) The fifty dollar ($50.00) application fee.

(a) The Department may designate how the fee is submitted; and

(b) The Department may require a convenience fee if payment is submitted by

credit card.

(3) Written certification provided by the physician within thirty (30) days prior to the

submittal of the application documenting that:

(a) The Physician has established a physician-patient relationship with the

qualifying patient as defined by the Arkansas State Medical Board;

(b) The Physician has completed a full assessment of the qualifying patient’s

medical history and current medical condition;

(d) Documentation that the qualifying patient has a qualifying medical

condition.

(B) Designated Caregivers. The Department shall issue a registry identification card for a

designated caregiver who submits the following:

(1) An application for a Designated Caregiver registry identification card that must

include the following:

(a) The name and date of birth of the designated caregiver;

(b) The address of the designated caregiver;

assisting;

(d) A signed statement by the designated caregiver that he or she will not

divert marijuana to anyone who is not allowed to possess it under the Amendment;

(e) A copy of the applicant’s driver’s license or identification card issued by

the State of Arkansas.

(2) The fifty dollar ($50.00) application fee;

(a) The Department may designate how the fee is submitted; and

(b) The Department may require a convenience fee if payment is submitted by

credit card.

(3) The following documentation from the qualifying patient’s physician:

(a) The qualifying patient’s qualifying medical condition; and

(b) A statement that the qualifying patient is disabled or under the age of

eighteen (18).

(4)(a) The applicant shall complete a criminal history check form as required by the

Department and shall request the Identification Bureau of the Department of Arkansas State

Police to conduct a state or national criminal history check, or both, on the applicant.

(b) The applicant shall pay all appropriate fees for the state or national

criminal history check, or both, as set forth by the Department.

application.

(d) The Department shall conduct a state or national criminal history check, or

both, on the applicant and determine whether the applicant is disqualified from

registration based on the report of the applicant's criminal history and forward its

determination to the applicant.

under eighteen (18) years of age, unless the following conditions are met:

(1) The qualifying patient’s physician has documented that he or she has explained

the potential risks and benefits of the medical use of marijuana to both the qualifying patient and

his or her parent, guardian or legal custodian; and

(2) The parent, guardian or legal custodian consents in writing to the following:

(a) To allow the qualifying patient’s medical use of marijuana;

(b) To assist the qualifying patient in the medical use of marijuana; and

of the medical use of marijuana by the qualifying patient.

(3) The parent, guardian, or legal custodian registers as a designated caregiver for the

qualifying patient.

(D) Visiting Patients.

(1) A visiting qualifying patient may obtain marijuana from a dispensary upon

producing evidence of his or her registry identification card or its equivalent that is issued under

the laws of another state, district, territory, commonwealth, or insular possession of the United

States.

(a) The dispensary shall retain a copy of the registry identification card or its

equivalent and his or her proper identification in a manner prescribed by the Department.

(b) The dispensary shall require the visiting patient to certify, in a form

required by the Department, that they have been diagnosed by a physician to have one or more

qualifying medical conditions.

(E) Renewal. A registry identification card expires one (1) year after the date of issuance.

(1) A registry identification card may expire on a date earlier than one year after the

date of issuance, if the physician states in the written certification that he or she believes the

qualifying patient would benefit from the medical use of marijuana only until a specified earlier

date. The specified earlier date will be the expiration date.

(2) At least thirty (30) days before the expiration of the registry identification card, a

qualifying patient or designated caregiver shall reapply for a registry identification card. The

application for renewal shall require the same information as the initial application.

(F) Department Review of Applications and Renewals. The Department shall review the

information contained in an application or renewal for a qualifying patient or designated

caregiver registry identification card within fourteen (14) days of receiving all the information

required for the application, including the written certification from the physician.

(1) The Department shall deny an application or renewal if:

(a) The applicant had a previous registry identification card revoked in this

state or any other jurisdiction where medical marijuana use is allowed;

(b) The written certification was not made in the context of a physician-

patient relationship; or

(d) The application or written certification was falsified in any way.

(2) The Department may revoke the registry identification card of any cardholder

who:

(a) Transfers marijuana to a person who is not a qualifying patient, visiting

patient, or designated caregiver with a valid registry identification card; or

(b) Knowingly violates any provision of the Amendment or these rules.

(3) The denial of an application, denial of an application renewal or revocation of a

registry identification card is considered a final agency action by the Department, subject to

judicial review by the Pulaski County Circuit Court.

(G) Confidentiality.

(1) The Department shall maintain a list of all the persons to whom qualifying patient

and designated caregiver registry identification cards have been issued.

(a) This list shall be confidential, and release of information on this list is

exempt under the Freedom of Information Act, Ark. Code Ann. §§ 25-19-101 et seq.

(b) Information from this list may be shared with the Alcoholic Beverage

Control Division and the Medical Marijuana Commission, but only as necessary.

(2) All documentation submitted by qualifying patients or designated caregivers,

including but not limited to applications and written certifications, shall remain confidential.

(3) The Department shall verify to law enforcement personnel whether a registry

identification card is valid without disclosing more information than is reasonably necessary to

verify the authenticity of the registry identification card.

SECTION V. LABELING

(A) The purpose of this section is to set the minimum standards for the labeling of usable

marijuana that is sold to a qualifying patient or designated caregiver by a dispensary or given by

a qualifying patient or designated to another qualifying patient or designated caregiver.

(1) Usable marijuana received or transferred by a dispensary, qualifying patient or

designated caregiver must meet the labeling requirements in these rules.

(2)(a) A dispensary must return usable marijuana that does not meet labeling

requirements in these rules to the individual who transferred it to the dispensary and document to

whom the item was returned, what was returned and the date of the return; or

(b) Dispose of any usable marijuana that does not meet labeling requirements

and that cannot be returned in a manner specified by the Department.

(B) Usable Marijuana Labeling Requirements

(1) Prior to usable marijuana being sold or transferred to a qualifying patient or

designated caregiver, the container holding the usable marijuana must have a label that has the

following information:

(a) Producer’s business or trade name and cultivation facility or dispensary

number;

(b) Business or trade name of cultivation facility or dispensary or cultivation

facility or dispensary that packaged or distributed the product, if different from the producer;

(d) Date of harvest;

(e) Name of strain;

(f) Net weight in U.S. customary and metric units;

(g) Concentration of THC and CBD;

(h) Activation time expressed in words or through a pictogram;

(i) Name of the lab that performed any test, any associated test batch number

and any test analysis date;

(j) Universal symbol;

(k) A warning that states: "For use by qualified patients only. Keep out of

reach of children.";

(l) A warning that states: “Marijuana use during pregnancy or breastfeeding

poses potential harms.”; and

(m) A warning that states: "This product is not approved by the FDA to treat,

cure, or prevent any disease".

(1) Prior to a cannabinoid concentrate or extract being sold or transferred to a

qualifying patient or designated caregiver, the container holding the concentrate or extract must

have a label that has the following information:

(a) Cultivation facility or dispensary’s business or trade name and cultivation

facility or dispensary number;

(b) Business or trade name of cultivation facility or dispensary that packaged

or distributed the product, if different from the cultivation facility or dispensary;

(d) Product identity (concentrate or extract);

(e) Date the concentrate or extract was made;

(f) Net weight or volume in U.S. customary and metric units;

(g) If applicable, serving size and number of servings per container or amount

suggested for use by the qualifying patient at any one time;

(h) Concentration or amount by weight or volume of THC and CBD in each

amount suggested for use and in the container;

(i) Activation time, expressed in words or through a pictogram;

(j) Name of the lab that performed any test, any associated test batch number

and any test analysis date;

(k) Universal symbol;

(l) A statement that reads:

(i) "This product is not approved by the FDA to treat, cure, or prevent

any disease";

(ii) "For use by qualifying patients only. Keep out of reach of

children.";

(iii) "DO NOT EAT" in bold, capital letters; and

(iv) “Marijuana use during pregnancy or breastfeeding poses potential

harms.”

(D) General Label Requirement, Prohibitions and Exceptions

(1) Principal Display Panel.

(a) Every container that contains usable marijuana for sale or transfer to a

qualifying patient or designated caregiver must have a principal display panel.

(b) If a container is placed within packaging for purposes of displaying the

marijuana item for sale or transfer to a qualifying patient or designated caregiver, the packaging

must have a principal display panel.

and universal symbol, if applicable.

(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 qualified patient or designated caregiver.

(b) Comply with the National Institute of Standards and Technology (NIST)

Handbook 130 (2017), Uniform Packaging and Labeling Regulation, incorporated by reference.

(i) Statements required by subsections (C)(1)(l)(ii) and (iv) must be in

at least 18 point.

(d) Be in English, though it can also be in other languages; and

(e) Be unobstructed and conspicuous.

(3) Usable marijuana may have one or more labels affixed to the container or

packaging.

(4) Usable marijuana 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 usable marijuana and on

any packaging that is used to display usable marijuana for sale or transfer to a qualifying patient

or designated caregiver that includes at least the following:

(i) Information required on a principal display panel, if applicable for

the type of usable marijuana;

(ii) Cultivation facility or dispensary business or trade name and

cultivation facility or dispensary number;

(iii) For cultivation facility or dispensaries, a package unique

identification number;

(iv) Concentration of THC and CBD; and

(v) Required warnings; and

(b) Must include all other required label information not listed in subsection

(4)(a) on an outer container or package, or on a leaflet that accompanies the usable marijuana.

(5) Usable marijuana in a container that is placed in packaging that is used to display

the usable marijuana for sale or transfer to a qualifying patient or designated caregiver must

comply with the labeling requirements in these rules, even if the container qualifies for the

exception under subsection (4).

(6) The universal symbol:

(a) Must be at least 0.48 inches wide by 0.35 inches high.

(b) May only be used by a cultivation facility or dispensary.

http://www.healthy.arkansas.gov/Pages/MedMarijuana.aspx.

(7) 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 from well-designed studies conducted in a manner which is consistent with

generally recognized scientific 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.

(8) Usable marijuana that falls within more than one category must comply with the

labeling requirements that apply to both categories, with the exception of the "DO NOT EAT"

warning if the product is intended for human consumption.

(9) The THC and CBD amount required to be on a label must be the value calculated

by the laboratory that did the testing.

(10) If usable marijuana has more than one test batch number, laboratory, or test

analysis date associated with the usable marijuana that is being sold or transferred, each test

batch number, laboratory and test analysis date must be included on a label.

(11) If usable marijuana 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.

(12) Exit packaging must contain a label that reads: "Keep out of the reach of

children."

SECTION VI. TESTING STANDARDS FOR USABLE MARIJUANA

(A) These rules are applicable to cultivation facilities and dispensaries.

(1) A cultivation facility or dispensary may not:

(a) Transfer usable marijuana that is not sampled and tested in accordance

with these rules; or

(b) Accept the transfer of usable marijuana that is not sampled and tested in

accordance with these rules.

(B) Ordering Tests

A cultivation facility or dispensary must provide a laboratory, prior to a laboratory taking

samples, with the following:

(1) A written request of analysis for each test the laboratory is being requested

to conduct; and

(2) Notification of whether the batch is being re-sampled because of a failed

test and the failed test results.

(1) A cultivation facility or dispensary must test every batch of usable marijuana,

intended for use by a qualified patient, prior to selling or transferring the usable marijuana for the

following:

(a) Pesticides in accordance with § XIII.

(b) Water activity and moisture content in accordance with § XV.

(d) Heavy Metals in accordance with § XVII.

(2) A cultivation facility or dispensary must test every batch of usable marijuana

intended for use by a cultivation facility or dispensary for water activity and moisture content in

accordance with § XV, unless the cultivation facility or dispensary uses a method of processing

that results in effective sterilization.

(3) A cultivation facility or dispensary must test a harvest lot of marijuana or usable

marijuana for microbiological contaminants in accordance with § XII, or upon written request by

the Department or Division.

(4) In lieu of ordering and arranging for the sampling and testing required in this rule,

a cultivation facility may transport batches of usable marijuana to a dispensary and the

dispensary may order and arrange for the sampling and testing of the batches, in accordance with

these rules.

SECTION VII. TESTING REQUIREMENTS FOR CONCENTRATES AND

EXTRACTS

(A) A cultivation facility or dispensary must test every process lot of cannabinoid concentrate

or extract for use by a qualified patient prior to selling or transferring the cannabinoid

concentrate or extract for the following:

(a) Pesticides in accordance with § XIII.

(b) Solvents in accordance with § XIV.

(d) Heavy Metals in accordance with § XVII

(B) A cultivation facility or dispensary is exempt from testing for solvents under this rule if

the cultivation facility or dispensary:

(1) Did not use any solvent listed in Appendix B, Table 2; and

(2) Only used a mechanical extraction process to separate cannabinoids from the

marijuana; or

(3) Used only water, animal fat or vegetable oil as a solvent to separate the

cannabinoids from the marijuana.

extract for microbiological contaminants in accordance with § XII, or upon written request by

the Department or the Commission.

SECTION VIII. BATCH REQUIREMENTS

(A) Usable marijuana.

(1) A cultivation facility or dispensary must separate each harvest lot into no larger

than 10 pound batches.

(2) Notwithstanding subsection (A)(1) of this section, a cultivation facility or

dispensary may combine batches for purposes of having a batch sampled if each batch is

intended for use by a cultivation facility or dispensary 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

(3) A cultivation facility or dispensary may not combine harvest lots into a batch for

purposes of sampling and testing for THC or CBD.

(4) If harvest lots are combined in accordance with subsection (A)(2) of this section,

the batch must be labeled so that it identifies the different harvest lots that were combined.

(B) Cannabinoid concentrates and extracts.

(1) A process lot is considered a batch.

that unique batch number must be:

(1) Documented and maintained in the cultivation facility or dispensary records for at

least two years and available to the Department upon request;

(2) Provided to the individual responsible for taking samples; and

(3) Included on the batch label as required in § XI.

(D) A cultivation facility or dispensary may not reuse a unique batch number.

SECTION IX. SAMPLING AND SAMPLE SIZE

(A) Usable marijuana.

(1) Usable marijuana may only be sampled after it is cured, unless the usable

marijuana is intended for sale or transfer to a cultivation facility or dispensary to make a

cannabinoid concentrate or extract.

(2) 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

Appendix A, §1(A).

(B) Cannabinoid concentrates extracts and products.

(1) Enough samples from a batch must be taken to ensure that the required attributes

in the batch to be tested are homogenous and consistent with the laboratory’s accredited

sampling policies and procedures described in Appendix A, §1(A).

SECTION X. SAMPLING PERSONNEL REQUIREMENTS; SAMPLING

RECORDKEEPING

(A) Only individuals employed by a laboratory sampling under these rules may take samples.

(B) Sampling may be conducted at a cultivation facility or dispensary’s premises or the

Cultivation facility or dispensary may transport the batch to a laboratory for sampling under

these rules.

(1) Follow the laboratory’s accredited sampling policies and procedures;

(2) Follow chain of custody procedures consistent with TNI EL Standard V1M2 5.7

and 5.8; and

(D) A laboratory must maintain the documentation required in these rules for at least two

years and must provide that information to the Department upon request.

SECTION XI. CULTIVATION FACILITY OR DISPENSARY REQUIREMENTS

FOR LABELING AND RECORDKEEPING

(A) Following samples being taken from a harvest or process lot batch, a cultivation facility

or dispensary must:

(1) Label the batch with the following information:

(a) The cultivation facility or dispensary’s registration number;

(b) The harvest or process lot unique identification number;

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."

(2) Store and secure the batch in a manner that prevents the product from being

tampered with or transferred prior to test results being reported.

(3) Be able to easily locate a batch stored and secured and provide that location to the

Department or a laboratory upon request.

(B) If the samples pass testing, the product may be sold or transferred.

§ XVIII.

SECTION XII. STANDARDS FOR TESTING MICROBIOLOGICAL

CONTAMINANTS

(A) Usable marijuana required to be tested for microbiological contaminants must be sampled

using appropriate aseptic technique and tested by a laboratory for total coliform count.

(B) If a laboratory detects the presence of any coliforms the sample must be assessed for

Escherichia coli (E. coli).

E. coli at more than 100 colony forming units per gram in a sample:

(1) During an initial test where no reanalysis is requested; or

(2) Upon reanalysis as described in § XVIII(A).

SECTION XIII. STANDARDS FOR TESTING PESTICIDES

(A) Usable marijuana required to be tested for pesticides must be tested by a laboratory for

the analytes listed in Appendix B, Table 1.

(B) A batch fails pesticide testing if a laboratory detects the presence of a pesticide above the

action levels listed in Appendix B, Table 1 in a sample:

(1) During an initial test where no reanalysis is requested; or

(2) Upon reanalysis as described in § XVIII(A).

SECTION XIV. STANDARDS FOR TESTING SOLVENTS

(A) Usable marijuana required to be tested for solvents must be tested by a laboratory for the

analytes listed in Appendix B, Table 2.

(B) A batch fails solvent testing if a laboratory, during an initial test where no reanalysis is

requested or upon reanalysis as described in § XVIII(A):

(1) Detects the presence of a solvent above the action level listed in Appendix B,

Table 2; or

(2) Calculates a RPD of more than 20 percent between the field primary result of the

sample and the field duplicate result.

SECTION XV. STANDARDS FOR TESTING WATER ACTIVITY AND

MOISTURE CONTENT

(A) Usable marijuana must be tested by a laboratory for:

(1) Water activity; and

(2) Moisture content.

(B) If a sample has a water activity rate of more than 0.65 Aw the sample fails.

the cultivation facility or dispensary but the sample does not fail.

SECTION XVI. STANDARDS FOR THC AND CBD TESTING

(A) A laboratory must test for the following when testing usable marijuana for potency:

(1) THC.

(2) THCA.

(3) CBD.

(4) CBDA.

(B) A process lot of a cannabinoid concentrate or extract fails potency testing if, based on an

initial test where no reanalysis is requested or upon reanalysis as described in § XVIII(A):

(1) The amount of THC, as calculated pursuant to Appendix A, §1, between samples

taken from the batch exceeds 30 percent RSD.

SECTION XVII. STANDARDS FOR TESTING FOR HEAVY METALS

(A) Usable marijuana must be tested by a laboratory for the metals listed in Appendix B,

Table 3.

(B) A batch fails metals testing if a laboratory, during an initial test where no reanalysis is

requested or upon reanalysis as described in § XVIII(A) detects the presence of metals above the

action level listed in Appendix B, Table 3.

SECTION XVIII. FAILED TEST SAMPLES

(A) 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 order for the batch to pass testing.

(B) If a sample fails a test or a reanalysis under subsection (A) of this section, the batch:

(1) May be remediated or sterilized in accordance with this rule; or

(2) If it is not or cannot be remediated or sterilized under this rule, it must be

destroyed in a manner specified by the Commission.

that has failed a test, the Cultivation facility or dispensary must notify the Cultivation facility or

dispensary to whom the batch is sold or transferred of the failed test.

(D) Failed microbiological contaminant testing.

(1) 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

method effectively sterilizes the batch, such as a method using a hydrocarbon based solvent or a

closed loop system.

(2) 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 effectively sterilizes the batch, such as a method using a hydrocarbon based solvent or a

closed loop system.

(3) A batch that is sterilized in accordance with subsection (D)(1) or (D)(2) of this

section must be sampled and tested in accordance with these rules and must be tested, if not

otherwise required for that product, for microbiological contaminants, solvents and pesticides.

(4) A batch that fails microbiological contaminant testing after undergoing a

sterilization process in accordance with subsection (D)(1) or (D)(2) of this section must be

destroyed in a manner specified by the Commission.

(E) Failed solvent testing.

(1) 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.

(2) A batch that is remediated in accordance with subsection (E)(1) of this section

must be sampled and tested in accordance with these rules and must be tested if not otherwise

required for that product under these rules, for solvents and pesticides.

(3) 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 Commission.

(F) Failed water activity testing.

(1) 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.

(2) A batch that undergoes additional drying or curing as described in subsection

(F)(1) of this section must be sampled and tested in accordance with these rules.

(G) Failed pesticide testing.

(1) 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 Commission.

(2) The Department must report to the Arkansas Department of Agriculture all test

results that show that a sample failed a pesticide test.

(H) Failed potency testing.

(1) Usable marijuana that fails potency testing under §§ XVI(B)(1) or (C)(1) may be

repackaged in a manner that enables the item to meet the standard in §§ XVI(B)(1) or (C)(1).

(2) Usable marijuana that is repackaged in accordance with this section must be

sampled and tested in accordance with these rules.

(I) 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 Commission.

(J) A cultivation facility or dispensary 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.

(K) A cultivation facility or dispensary must, as applicable:

(1) Have detailed procedures for sterilization processes to remove microbiological

contaminants and for reducing the concentration of solvents.

(2) Document all sampling, testing, sterilization, remediation and destruction that are

a result of failing a test under these rules.

SECTION XIX. TENTATIVE IDENTIFICATION OF COMPOUNDS

(A) Tentatively Identified Compounds (TICs) are compounds detected in a sample using gas

chromatography mass spectrometry that are not among the target analytes for the residual solvent

analysis.

(B) The Department may initiate an investigation of a cultivation facility or dispensary upon

receipt of a TICS report from a laboratory and may require a cultivation facility or dispensary to

submit samples for additional testing, including testing for analytes that are not required by these

rules, at the cultivation facility or dispensary’s expense.

SECTION XX. AUDIT AND RANDOM TESTING

(A) The Department may require a cultivation facility or dispensary to submit samples

identified by the Department to a laboratory of the cultivation facility or dispensary’s choosing to

be tested in order to determine whether a cultivation facility or dispensary is in compliance with

these rules, and may require additional testing that is not required by these rules.

(B) 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 Department

approved methods.

microbiological contaminants that ensures each cultivation facility or dispensary tests every

product for microbiological contaminants at least once a year.

SECTION XXI. TEMPORARY CULTIVATION FACILITY OR DISPENSARY

PESTICIDE TESTING REQUIREMENTS

(A) Notwithstanding these rules, if the Department finds there is insufficient laboratory

capacity for the testing of pesticides, the Department may permit randomly chosen samples from

batches of usable marijuana to be tested for pesticides by a licensed laboratory rather than

requiring every batch of usable marijuana from a harvest lot to be tested for pesticides.

(B) The Department must ensure that samples from at least one batch of every harvest lot are

tested for pesticides.

or dispensary’s harvest lot fails a pesticide test every batch from the harvest lot must be tested

for pesticides.

(D) If the randomly chosen samples from batches of usable marijuana that are tested for

pesticides all pass, the entire harvest lot is considered to have passed pesticide testing and may

be transferred or sold.

SECTION XXII. PETITIONS TO ADD MEDICAL CONDITIONS OR

TREATMENTS

(A) The Department will only accept petitions that are sent via U.S. mail.

Arkansas Department of Health

Medical Marijuana Program

4815 West Markham, Slot 50

Little Rock, AR 72205

(B) Each petition is limited to a single medical condition or disease.

(1) The specific name and brief description of the proposed debilitating medical

condition or disease, including any applicable ICD-10 diagnostic code(s);

(2) The extent to which the debilitating medical condition or disease itself, and/or the

treatments, cause severe suffering and impair a person's daily life;

(3) A description of the conventional medical therapies, other than those that cause

suffering, available to alleviate the suffering caused by the proposed debilitating medical

condition or disease;

(4) A description of the proposed benefits from the medical use of cannabis specific

to the proposed debilitating medical condition or disease;

(5) Evidence generally accepted by the medical community and other experts that the

use of medical cannabis alleviates suffering caused by the debilitating medical disease and/or

treatment (this includes but is not limited to full-text peer-reviewed published journals or other

completed medical studies); and

(6) Letters of support for the use of medical cannabis from physicians and/or other

licensed health care providers knowledgeable about the condition or disease, including, if

applicable, a letter from the physician with whom the petitioner has a bona-fide physician-patient

relationship along with any medical, testimonial, or scientific documentation.

(D) If the petition meets all requirements, it will be referred for a public hearing. Petitioners

will be notified in advance of the date, time and location of the public hearing, and will be

allowed to offer verbal or written comments, as will other members of the public. Notice of the

public hearing shall conform.

(E) If a medical condition, medical treatment or disease in a petition has been previously

considered and rejected, or is determined to be substantially similar to a previously-rejected

condition, treatment or disease, the Department may deny the petition without first referring for a

public hearing, unless new scientific research that supports the request is offered in the petition.

(F) After reviewing the petitions, supporting evidence and public comments, the Program

will issue a recommendation to the Director as to which of the conditions, diseases or treatments

should be added as qualifying conditions. In considering a petition, the Department shall

recommend to add medical conditions or treatments to the list of qualifying medical conditions if

patients suffering from the medical conditions or undergoing the treatments in question would

derive therapeutic benefit from the use of marijuana, taking into account the positive and

negative health effects of such use.

(G) The Director shall, after hearing, approve or deny a petition within one hundred twenty

(120) days of submission of the petition. The Director will make the final determination. If the

decision is to add the condition, treatment or disease, the Department will proceed to propose

regulations to expand the list.

APPENDIX A

SECTION I. MARIJUANA ITEM SAMPLING PROCEDURES AND TESTING

(A) Sampling

(1) A laboratory must prepare usable marijuana sampling policies and procedures that

contain all of the information necessary for collecting and transporting samples from usable

marijuana in a manner 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.

(2) 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 for the analyses requested.

(3) 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.

(4) A laboratory must comply with any recording requirements for samples and

subsamples in the 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.

with Section X 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 cases where the sample collector and analyst are the same individual, or

the laboratory pre-assigns numbers to sample containers, the unique identification number may

be the same as the field identification code.

(5) Combining subsamples.

(a) Subsamples collected from the same batch must be combined into a single

sample by a laboratory prior to testing.

(b) Subsamples and samples collected from different batches may not be

combined.

(B) THC and CBD testing validity. When testing a sample for THC and CBD a laboratory

must comply with additional method validation as follows:

(1) Run a laboratory control standard in accordance with TNI standards requirements

within acceptance criteria of 70 percent to 130 percent recovery.

(2) Analyze field duplicates of samples within precision control limits of plus or

minus 20 percent RPD, if field duplicates are required.

(1) 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).

(2) 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).

(3) Each test report must include the total THC and total CBD.

(D) 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)]

(E) Calculating RPD and RSD.

(1) A laboratory must use the following calculation for determining RPD:

=

(sample result – duplicate result)

(sample result + duplicate result)/2

(2) A laboratory must use the following calculation for determining RSD:

%=





× 100%

= 

(



)



(1)





(3) For purposes of this section:

(a) s = standard deviation.

(b) n = total number of values.

= each individual value used to calculate mean.

(d) x = mean of n values.

(4) 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.

(F) Tentative Identification of Compounds (TIC).

(1) 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 may contain compounds that are not included in the list of analytes the laboratory is

testing for, the laboratory must attempt to achieve tentative identification.

(2) Tentative identification is achieved by searching NIST 2014 or an equivalent

database (>250,000 compounds).

(3) A laboratory shall report to the cultivation facility or dispensary and the

Department or the Division, depending on which agency has jurisdiction, up to five tentatively

identified compounds (TICS) that have the greatest apparent concentration.

(4) 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.

(G) A laboratory must provide:

(1) Any pesticide test result to the Department of Agriculture upon the Department of

Health’s request.

(2) A sample or a portion of a sample to the Department of Agriculture upon the

Department of Health’s request and document the chain of custody from the laboratory to the

Department of Agriculture.

(H) A laboratory performing tests for a cultivation facility or dispensary must enter any

information required by the Division.

(I) A laboratory performing tests for a cultivation facility or dispensary must comply with

the documentation requirements in § X.

(J) The Department may, in its discretion, deviate from TNI Standards in order to comply

with these rules based on the state’s needs.

SECTION II Reporting Usable marijuana Test Results

(A) Within 24 hours of completion of the laboratory’s data review and approval procedures, a

laboratory must report all failed tests for testing required, except for failed water activity,

whether or not the lab is reanalyzing the sample under § XVIII:

(1) To the Department electronically if performing testing for a cultivation facility or

dispensary.

(B) The laboratory must report all test results required under these rules that have not been

reported under subsection (A) of this section in a manner prescribed by the Department.

(LOQ) for each analyte listed in Appendix B, Table 1 and Appendix B, Table 2.

(D) 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."

(E) A test report must include any associated test batch numbers and the date each test was

completed.

(F) A laboratory that is reporting failed test results to the Department must report the failed

test at the same time or before reporting to the cultivation facility or dispensary.

(G) In addition to reporting failed test results, a laboratory conducting testing for a cultivation

facility or dispensary must report to the Department electronically at any pesticide testing report

with a "detected" as described in subsection (D) of this section.

(H) Test results expire after one year.

APPENDIX B

Table 1. Pesticide analytes and their

action levels

Analyte

Chemical

Abstract

Services

(CAS)

Registry

Number

Action

Level

ppm

Abamectin

71751-41-2

0.5

Acephate

30560-19-1

0.4

Acequinocyl

57960-19-7

Acetamiprid

135410-20-7

0.2

Aldicarb

116-06-3

0.4

Azoxystrobin

131860-33-8

0.2

Bifenazate

149877-41-8

0.2

Bifenthrin

82657-04-3

0.2

Boscalid

188425-85-6

0.4

Carbaryl

63-25-2

0.2

Carbofuran

1563-66-2

0.2

Chlorantraniliprole

500008-45-7

0.2

Chlorfenapyr

122453-73-0

Chlorpyrifos

2921-88-2

0.2

Clofentezine

74115-24-5

0.2

Cyfluthrin

68359-37-5

Cypermethrin

52315-07-8

Daminozide

1596-84-5

DDVP

(Dichlorvos)

62-73-7

0.1

Diazinon

333-41-5

0.2

Dimethoate

60-51-5

0.2

Ethoprophos

13194-48-4

0.2

Permethrins should be measured as

Analyte

Chemical

Abstract

Services

(CAS)

Registry

Number

Action

Level

ppm

Etofenprox

80844-07-1 0.4

Etoxazole

153233-91-1 0.2

Fenoxycarb

72490-01-8 0.2

Fenpyroximate 134098-61-6 0.4

Fipronil 120068-37-3 0.4

Flonicamid

158062-67-0 1

Fludioxonil

131341-86-1 0.4

Hexythiazox

78587-05-0 1

Imazalil

35554-44-0

0.2

Imidacloprid

138261-41-3

0.4

Kresoxim-methyl 143390-89-0 0.4

Malathion 121-75-5 0.2

Metalaxyl 57837-19-1 0.2

Methiocarb 2032-65-7 0.2

Methomyl 16752-77-5 0.4

Methyl parathion 298-00-0 0.2

MGK-264 113-48-4 0.2

Myclobutanil 88671-89-0 0.2

Naled 300-76-5 0.5

Oxamyl 23135-22-0 1

Paclobutrazol

76738-62-0

0.4

Permethrins

52645-53-1

0.2

Phosmet 732-11-6 0.2

Piperonyl_butoxide 51-03-6 2

Prallethrin 23031-36-9 0.2

cumulative

residue of cis- and trans-

permethrin isomers (CAS

numbers 54774-45-

7 and 51877-74-8 respectively).

Analyte

Chemical

Abstract

Services

(CAS)

Registry

Number

Action

Level

ppm

Propiconazole

60207-90-1

0.4

Propoxur

114-26-1

0.2

Pyrethrins

8003-34-7

Pyridaben

96489-71-3

0.2

Spinosad

168316-95-8

0.2

Spiromesifen

283594-90-1

0.2

Spirotetramat

203313-25-1

0.2

Spiroxamine

118134-30-8

0.4

Tebuconazole

80443-41-0

0.4

Thiacloprid

111988-49-9

0.2

Thiamethoxam

153719-23-4

0.2

Trifloxystrobin

141517-21-7

0.2

Pyrethrins should be measured as the cumulative

residues of pyrethrin 1, cinerin 1, and jasmolin 1 (CAS

numbers 121-21-1, 25402-06-6, and 4466-14-2

respectively).

Table 2. List of solvents and their action

levels

Solvent

Chemical

Abstract

Services

(CAS)

Registry

Number

Action

Level

(µg/g)

1,2-

Dimethoxyethane

110-71-4

100

1,4-Dioxane

123-91-1

380

1-Butanol

71-36-3

5000

1-Pentanol

71-41-0

5000

1-Propanol

71-23-8

5000

2-Butanol

78-92-2

5000

2-Butanone

78-93-3

5000

2-Ethoxyethanol

110-80-5

160

2-methylbutane

78-78-4

5000

2-Propanol (IPA)

67-63-0

5000

Acetone

67-64-1

5000

Acetonitrile

75-05-8

410

Benzene

71-43-2

Butane

106-97-8

5000

Cumene

98-82-8

Cyclohexane

110-82-7

3880

Dichloromethane

75-09-2

600

2,2-dimethylbutane

75-83-2

290

2,3-dimethylbutane

79-29-8

290

1,2-dimethylbenzene

95-47-6

See

Xylenes

1,3-dimethylbenzene

108-38-3

See

Xylenes

Solvent

Chemical

Abstract

Services

(CAS)

Registry

Number

Action

Level

(µg/g)

1,4-dimethylbenzene

106-42-3

See

Xylenes

Dimethyl sulfoxide 67-68-5 5000

Ethanol 64-17-5 5000

Ethyl acetate 141-78-6 5000

Ethylbenzene

100-41-4

See

Xylenes

Ethyl ether 60-29-7 5000

Ethylene glycol 107-21-1 620

Ethylene Oxide 75-21-8 50

Heptane 142-82-5 5000

n-Hexane 110-54-3 290

Isopropyl acetate 108-21-4 5000

Methanol 67-56-1 3000

Methylpropane 75-28-5 5000

2-Methylpentane

107-83-5

290

3-Methylpentane

96-14-0

290

N,N-

dimethylacetamide

127-19-5

1090

N,N-

dimethylfromamide

68-12-2

880

Pentane 109-66-0 5000

Propane 74-98-6 5000

Pyridine

110-86-1

200

Sulfolane

126-33-0

160

Tetrahydrofuran 109-99-9 720

Toluene 108-88-3 890

Xylenes

1330-20-7 2170

Limit based on similarity to pentane

Limit based on similarity with n-hexane

Combination of: 1,2-dimethylbenzene, 1,3-

dimethylbenzene, 1,4-dimethylbenzene, and ethyl

benzene

Table 3. List of Metals and their action levels

Metal

Action

Level

(µg/kg)

Arsenic (inorganic)

200

Cadmium

200

Lead

500

Mercury (total)

100

QUESTIONNAIRE FOR FILING PROPOSED RULES AND REGULATIONS

WITH THE ARKANSAS LEGISLATIVE COUNCIL AND JOINT INTERIM COMMITTEE

DEPARTMENT/AGENCY

Department of Health

DIVISION

Center for Health Protection/Section of Medical Marijuana

DIVISION DIRECTOR

Renee Mallory

CONTACT PERSON

Robert Brech

ADDRESS

4815 West Markham, St., Slot 31, Little Rock, AR

PHONE NO.

501-661-2297

FAX NO.

501-661-2357

E-

MAIL

robert.brech@arkansas.gov

NAME OF PRESENTER AT COMMITTEE

MEETING

Robert Brech

PRESENTER E-MAIL

robert.brech@arkansas.gov

INSTRUCTIONS

A. Please make copies of this form for future use.

B. Please answer each question completely using layman terms. You may use additional sheets, if

necessary.

If you have a method of indexing your rules, please give the proposed citation after “Short Title of

this Rule” below.

D. Submit two (2) copies of this questionnaire and financial impact statement attached to the front of

two (2) copies of the proposed rule and required documents. Mail or deliver to:

Donna K. Davis

Administrative Rules Review Section

Arkansas Legislative Council

Bureau of Legislative Research

One Capitol Mall, 5

Floor

Little Rock, AR 72201

*********************************************************************************

1. What is the short title of this

rule?

MEDICAL MARIJUANA REGISTRATION, TESTING, AND

LABELING

2. What is the subject of the proposed

rule?

Medical marijuana

3. Is this rule required to comply with a federal statute, rule, or regulation?

Yes

If yes, please provide the federal rule, regulation, and/or statute citation.

4. Was this rule filed under the emergency provisions of the Administrative

Procedure Act?

Yes

If yes, what is the effective date of the emergency

rule?

When does the emergency rule

expire?

Will this emergency rule be promulgated under the permanent provisions

of the Administrative Procedure Act?

Yes

5. Is this a new rule?

Yes

If yes, please provide a brief summary explaining the regulation. These rules govern the application for

and renewal of registry identification cards for qualifying patients and designated caregivers. These rules

also establish labeling and testing standards for marijuana distributed under the Medical Marijuana

Amendment of 2016, and how medical conditions may be added to the list of qualifying conditions.

Does this repeal an existing rule?

Yes

If yes, a copy of the repealed rule is to be included with your completed questionnaire. If it is being

replaced with a new rule, please provide a summary of the rule giving an explanation of what the rule

does.

Is this an amendment to an existing

rule?

Yes

If yes, please attach a mark-up showing the changes in the existing rule and a summary of the

substantive changes. Note: The summary should explain what the amendment does, and the mark-

up copy should be clearly labeled “mark-up.”

6. Cite the state law that grants the authority for this proposed rule? If codified, please give the Arkansas

Code citation. Amendment No. 98 of the Constitution of the State of Arkansas of 1874, The Medical

Marijuana Amendment of 2016, § 4

7. What is the purpose of this proposed rule? Why is it necessary? To implement the Board of Health's

responsibilities under the Amendment.

8. Please provide the address where this rule is publicly accessible in electronic form via the Internet as

required by Arkansas Code § 25-19-108(b).

http://www.healthy.arkansas.gov/aboutADH/Pages/RulesRegulations.aspx

9. Will a public hearing be held on this proposed rule?

Yes

If yes, please complete the following:

Date:

03/10/2017

Time:

2:00 p.m.

Place:

Auditorium of the Arkansas

Department of Health

10. When does the public comment period expire for permanent promulgation? (Must provide a date.)

It expired on 3-10-2017

11. What is the proposed effective date of this proposed rule? (Must provide a date.)

9/11/2017

12. Do you expect this rule to be controversial?

Yes

If yes, please

explain.

The Department is not aware of any significant controversy at this time

regarding this rule; however, the subject of medical marijuana continues to be

controversial.

13. Please give the names of persons, groups, or organizations that you expect to comment on these rules?

Please provide their position (for or against) if known.

Melissa Fults - Drug Policy Education Group

Storm Nolan - Arkansas Cannabis Industry Association

Steve Johnson

Robert Reed

Paul Danielson

Brian Nichol, Anesthesiologist & Pain Management Physician

Deborah Beuerman

Donna Will

Gene Ribley

Daniel Sanders

Dante Jacuzzi

Steve Jacobie

Christopher L. Travis

Justice J. Brooks

FINANCIAL IMPACT STATEMENT

PLEASE ANSWER ALL QUESTIONS COMPLETELY

DEPARTMENT

Department of Health

DIVISION

Center for Health Protection/Section of Medical Marijuana

PERSON COMPLETING THIS STATEMENT

Robert Brech

TELEPHONE NO.

501-661-2297

FAX NO.

501-661-2357

EMAIL:

robert.brech@arkansas.gov

To comply with Ark. Code Ann. § 25-15-204(e), please complete the following Financial Impact

Statement and file two copies with the questionnaire and proposed rules.

SHORT TITLE OF THIS RULE

Medical Marijuana Registration, Testing, and Labeling

1. Does this proposed, amended, or repealed rule have a financial impact?

Yes

2. Is the rule based on the best reasonably obtainable scientific, technical,

economic, or other evidence and information available concerning the

need for, consequences of, and alternatives to the rule?

Yes

3. In consideration of the alternatives to this rule, was this rule determined by

the agency to be the least costly rule considered?

Yes

If an agency is proposing a more costly rule, please state the following:

(a) How the additional benefits of the more costly rule justify its additional cost;

N/A

(b) The reason for adoption of the more costly rule;

N/A

if so, please explain; and;

N/A

(d) Whether the reason is within the scope of the agency’s statutory authority; and if so, please

explain.

N/A

4. If the purpose of this rule is to implement a federal rule or regulation, please state the following:

(a) What is the cost to implement the federal rule or regulation?

Current Fiscal Year

Next Fiscal Year

General Revenue

Federal Funds

Cash Funds

Special Revenue

Other (Identify)

Total

(b) What is the additional cost of the state rule?

Current Fiscal Year

Next Fiscal Year

General Revenue

Federal Funds

Cash Funds

Special Revenue

Other (Identify)

Total

5. What is the total estimated cost by fiscal year to any private individual, entity and business subject to

the proposed, amended, or repealed rule? Identify the entity(ies) subject to the proposed rule and

explain how they are affected.

Current Fiscal Year

Next Fiscal Year

$2,500,000

There will be a cost, but only to the individuals and corporations that choose to participate in the medical

marijuana industry. The labeling and minimum testing standards are necessary to protect the public. It is

expected that marijuana testing and labeling standards could cost cultivation facilities and dispensaries

approximately $1,000,000. The Department also expects to raise approxiamtely $1,500,000 from fees

paid by registrants.

6. What is the total estimated cost by fiscal year to state, county, and municipal government to

implement this rule? Is this the cost of the program or grant? Please explain how the government is

affected.

Current Fiscal Year

Next Fiscal Year

90,000

$780,000

The rule implements fees to pay for the cost of implementing and the ongoing costs to operate the

program. It is estimated to cost $780,000 the first full year and $1,500,000 thereafter.

7. With respect to the agency’s answers to Questions #5 and #6 above, is there a new or increased cost

or obligation of at least one hundred thousand dollars ($100,000) per year to a private individual,

private entity, private business, state government, county government, municipal government, or to

two (2) or more of those entities combined?

If YES, the agency is required by Ark. Code Ann. § 25-15-204(e)(4) to file written findings at the

time of filing the financial impact statement. The written findings shall be filed simultaneously

with the financial impact statement and shall include, without limitation, the following:

(1) a statement of the rule’s basis and purpose;

Yes

(2) the problem the agency seeks to address with the proposed rule, including a statement of whether

a rule is required by statute;

(3) a description of the factual evidence that:

(a) justifies the agency’s need for the proposed rule; and

(b) describes how the benefits of the rule meet the relevant statutory objectives and justify

the rule’s costs;

(4) a list of less costly alternatives to the proposed rule and the reasons why the alternatives do not

adequately address the problem to be solved by the proposed rule;

(5) a list of alternatives to the proposed rule that were suggested as a result of public comment and

the reasons why the alternatives do not adequately address the problem to be solved by the

proposed rule;

(6) a statement of whether existing rules have created or contributed to the problem the agency seeks

to address with the proposed rule and, if existing rules have created or contributed to the

problem, an explanation of why amendment or repeal of the rule creating or contributing to the

problem is not a sufficient response; and

(7) an agency plan for review of the rule no less than every ten (10) years to determine whether,

based upon the evidence, there remains a need for the rule including, without limitation,

whether:

(a) the rule is achieving the statutory objectives;

(b) the benefits of the rule continue to justify its costs; and

statutory objectives.

Written Findings

A statement of the rule's basis and purpose:

These rules establish labeling and testing standards for marijuana distributed under the Medical

Marijuana Amendment. It also establishes the fee to be paid by registrants.

The problem the agency seeks to address with the proposed rule, including a statement of whether a

rule is required by statute;

The rules seek to ensure that medical marijuana products sold in Arkansas are free from

unacceptable levels of pesticides, solvents and heavy metals. Labeling standards are critical to

inform the public of medical marijuana potency and to convey important health warnings.

A description of the factual evidence that:

(a) Justifies the agency's need for the proposed rule; and

As a plant product, it is imperative that the products be adequately tested and labeled to ensure

its safety.

(b) Describes how the benefits of the rule meet the relevant statutory objectives and justify the

rule's costs;

This is a newly approved constitutional amendment and program. By utilizing recommendations

from the Association of Public Health Laboratories, the Department developed these rules. The

costs associated with testing will be paid to private companies to perform the necessary tests.

A list of less costly alternatives to the proposed rule and the reasons why the alternatives do not

adequately address the problem to be solved by the proposed rule;

The Department is not aware of any alternatives.

A list of alternatives to the proposed rule that were suggested as a result of public comment and the

reasons why the alternatives do not adequately address the problem to be solved by the proposed rule;

There were comments suggesting that the testing of 10 pound batches was too costly and

perhaps the testing 100 pound batches should be allowed. However, the Department considers

it imperative that products ingested, especially through inhalation, must be tested and

determined free from contaminants. The Department will consider larger batches in the future

should it be determined to be a safe and effective.

A statement of whether existing rules have created or contributed to the problem the agency seeks to

address with the proposed rule.

N/A

If existing rules have created or contributed to the problem, an explanation of why amendment

or repeal of the rule creating or contributing to the problem is not a sufficient response; and

N/A

An agency plan for review of the rule no less than every ten (10) years to determine whether, based

upon the evidence, there remains a need for the rule, including without limitation whether:

The rule is achieving the statutory objectives;

The benefits of the rule continue to justify its costs; and

The rule can be amended or repealed to reduce costs while continuing to achieve the statutory

objections.

Since this is a new program, the Department intends to continually update and improve the

rules as evidence surfaces and updates and improvements become apparent and necessary.