Title 15 Cannabis Laws

Chapter 15.01 Tribe Hemp Production Regulations

15.01.010 Title

This chapter shall be known and cited as the "Saint Regis Mohawk Tribe Hemp Production Regulations".

15.01.020 Purpose, Authority and Jurisdiction

(a) The Saint Regis Mohawk Tribal Council ("Tribal Council") adopts these Hemp Production Regulations ("Regulations") to establish rules to govern the production of hemp on Mohawk Tribal Territory.

(b) Authority to adopt this chapter derives from the Saint Regis Mohawk Tribe's ("Tribe") inherent sovereignty to regulate activities within Mohawk Tribal Territory that includes the authority to regulate hemp production and the Agricultural Improvement Act of 2018, Pub. L. 115-334, December 20, 2018, 132 Stat. 4490 ("Farm Bill") and the U.S. Department of Agriculture's ("USDA") Final Rule (January 19, 2021), 86 FR 5596, recognizing a tribe's right to assume primary authority over hemp production.

(c) The Tribe's jurisdiction, as recognized in the USDA Final Rule, upon approval by USDA, extends to production of hemp with the Tribe's territory regardless of the extent of the Tribe's inherent regulatory authority.

15.01.030 Definitions

(a) The following terms and phrases used in this chapter are arranged in alphabetical order. More detailed definitions of some technical terms are contained in the USDA Final Rule, Subchapter A which is adopted and incorporated by reference in this chapter.

(1) "Acceptable hemp THC level" is when the application of the measurement of uncertainty to the reported delta-9 tetrahydrocannabinol content concentration level on a dry weight basis produces a distribution or range that includes 0.3% or less. For example, if the reported delta-9 tetrahydrocannabinol content concentration level on a dry weight basis is 0.35% and the measurement of uncertainty is +/- 0.06%, the measured delta-9 tetrahydrocannabinol content concentration level on a dry weight basis for this sample ranges from 0.29% to 0.41%. Because 0.3% is within the distribution or range, the sample is within the acceptable hemp THC level for plan compliance. This definition of "acceptable hemp THC level" affects neither the statutory definition of hemp, 7 U.S.C. § 1639o (1), in the 2018 Farm Bill nor the definition of "marihuana," 21 U.S.C. § 802(16), in the CSA.

(2) "Agricultural Marketing Service" or "AMS" means the Agricultural Marketing Service of the U.S. Department of Agriculture.

(3) "Cannabis" means a genus of flowering plants in the family Cannabaceae of which Cannabissativais a species, and Cannabis indica and Cannabis ruderalis are subspecies thereof. Cannabis refers to any form of the plant in which the delta-9 tetrahydrocannabinol concentration on a dry weight basis has not yet been determined.

(4) "Conviction" means any plea of guilty or nolo contendere, or any finding of guilt, except when the finding of guilt is subsequently overturned on appeal, pardoned, or expunged. For purposes of this chapter, a conviction is expunged when the conviction is removed from the individual's criminal history record and there are no legal disabilities or restrictions associated with the expunged conviction, other than the fact that the conviction may be used for sentencing purposes for subsequent convictions. In addition, where an individual is allowed to withdraw an original plea of guilty or nolo contendere and enter a plea of not guilty and the case is subsequently dismissed, the individual is no longer considered to have a conviction.

(5) "Corrective action plan" means a plan established by the Tribe for a licensed hemp producer to correct a negligent violation or non-compliance.

(6) "Criminal History Report" means the Federal Bureau of Investigation's Identity History Summary.

(7) "Culpable mental state greater than negligence" means to act intentionally, knowingly, willfully, or recklessly.

(8) "Decarboxylated" means the completion of the chemical reaction that converts THC-acid (THC-A) into delta-9-THC, the intoxicating component of cannabis. The decarboxylated value is also calculated using a conversion formula that sums delta-9-THC and eighty-seven and seven tenths (87.7) percent of THC-acid.

(9) "Decarboxylation" means the removal or elimination of carboxyl group from a molecule or organic compound.

(10) "Delta-9 tetrahydrocannabinol" or "THC" is the primary psychoactive component of cannabis. For the purposes of this part, delta-9 THC and THC are interchangeable.

(11) "Disposal" means an activity that transitions a non-compliant product into a non-retrievable or non-ingestible form. Such activities include plowing, tilling, or disking plant material into the soil; mulching, composting, chopping, or bush mowing plant material into green manure; burning plant material; burying plant material into the earth and covering with soil.

(12) "Drug Enforcement Administration" or "DEA" means the United States Drug Enforcement Administration.

(13) "Dry weight basis" means the ratio of the amount of moisture in a sample to the amount of dry solid in a sample. A basis for expressing the percentage of a chemical in a substance after removing the moisture from the substance. Percentage of THC on a dry weight basis means the percentage of THC, by weight, in a cannabis item (plant, extract, or other derivative), after excluding moisture from the item.

(14) "Entity" means a corporation, joint stock company, association, limited partnership, limited liability partnership, limited liability company, irrevocable trust, estate, charitable organization, or other similar organization, including any such organization participating in the hemp production as a partner in a general partnership, a participant in a joint venture, or a participant in a similar organization.

(15) "Farm Service Agency" or "FSA" is an agency of the United States Department of Agriculture.

(16) "Gas chromatography" or "GC" means a type of chromatography in analytical chemistry used to separate, identify, and quantify each component in a mixture. GC relies on heat for separating and analyzing compounds that can be vaporized without decomposition.

(17) "Geospatial location" means a location designated through a global system of navigational satellites used to determine the precise ground position of a place or object.

(18) "Hemp" means the plant species Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.

(19) "High-performance liquid chromatography" or "HPLC" is a type of chromatography technique in analytical chemistry used to separate, identify, and quantify each component in a mixture. HPLC relies on pumps to pass a pressurized liquid solvent containing the sample mixture through a column filled with a solid adsorbent material to separate and analyze compounds.

(20) "Key participants" means a sole proprietor, a partner in partnership, or a person with executive managerial control in a corporation. A person with executive managerial control includes persons such as a chief executive officer, chief operating officer and chief financial officer. This definition does not include non-executive managers such as farm, field, or shift managers.

(21) "Law enforcement agency" refers to the Saint Regis Mohawk Tribal Police Department or, in some circumstances, a Federal, State, or local law enforcement agency.

(22) "Lot" means a contiguous area in a field, greenhouse, or indoor growing structure containing the same variety or strain of cannabis throughout the area. The term lot also means the terms "farm," "tract," "field," and "subfield" as these are terms are used by FSA in 7 CFR 718.2 to define lot.

(23) "Marijuana" or "marihuana" means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. The term 'marihuana' does not include hemp, as defined in section 297A of the Agricultural Marketing Act of 1946 and does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination (7 U.S.C. 1639o). "Marihuana" means all cannabis that tests as having a concentration level of THC on a dry weight basis of higher than 0.3 percent.

(24) "Measurement of Uncertainty (MU)" is the parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the quantity subject to measurement.

(25) "Negligence" means the failure to exercise the level of care that a reasonably prudent person would exercise in complying with this chapter.

(26) "Post decarboxylation" means a value determined after the process of decarboxylation that determines the total potential delta-9 tetrahydrocannabinol content derived from the sum of the THC and THC-A content and reported on a dry weight basis. The post decarboxylation value of THC can be calculated by using a chromatograph technique using heat, gas chromatography, through which THCA is converted from its acid form to its neutral form, THC. Thus, this test calculates the total potential THC in a given sample. The post decarboxylation value of THC can also be calculated by using a high-performance liquid chromatograph technique, which keeps the THC-A intact, and requires a conversion calculation of that THC-A to calculate total potential THC in a given sample.

(27) "Produce" means to grow hemp plants for market, or for cultivation for market, in the United States. For purposes of this chapter it also includes, but is not limited to, cultivation, extraction, obtaining seeds, handling hemp, storage, transportation and shipment of hemp to market.

(28) "Remediation" refers to the process of rendering non-compliant cannabis, compliant. Remediation can occur by removing and destroying flower material, while retaining stalk, stems, leaf material, and seeds. Remediation can also occur by shredding the entire plant into a biomass like material, then re-testing the shredded biomass material for compliance.

(29) "Saint Regis Mohawk Tribe" or "Tribe" means the federally recognized Indian Tribe, the Saint Regis Mohawk Tribe with government offices in Akwesasne, New York.

(30) "Saint Regis Mohawk Tribal Police" means the law enforcement department for the Saint Regis Mohawk Tribe with police authority over Tribal Territory.

(31) "Secretary" means the Secretary of the U.S. Department of Agriculture.

(32) "Total THC" is the value determined after the process of decarboxylation, or the application of a conversion factor if the testing methodology does not include decarboxylation, that expresses the potential total delta-9 tetrahydrocannabinol content derived from the sum of the THC and THCA content and reported on a dry weight basis. This post-decarboxylation value of THC can be calculated by using a chromatograph technique using heat, such as gas chromatography, through which THCA is converted from its acid form to its neutral form, THC. Thus, this test calculates the total potential THC in a given sample. The total THC can also be calculated by using a liquid chromatograph technique, which keeps the THCA intact. This technique requires the use of the following conversion: [Total THC = (0.877 x THCA) + THC] which calculates the potential total THC in a given sample.

(33) "Tribal Member" or "Mohawk Tribal Member" means a person who is enrolled in the Tribe under the Tribe's Membership Code or a person who is eligible to be enrolled regardless of where they reside.

(34) "Tribal Member-Owned Business" or "Tribal Member Business" means an entity that is more than fifty percent (50%) owned and controlled by a Tribal Member. "Controlled" means to have controlling interest whereby a person holds a majority of a company's voting stock, giving them significant influence over any corporate actions. A person or group of persons having a controlling interest will be able to direct the course of a company and make strategic and operational decisions.

(35) "Tribal Territory" or "Mohawk Tribal Territory" means all lands within the 1796 Treaty with the Seven Nations of Canada (97 Stat. 55) and includes any other lands over which the Tribe exercises jurisdiction. It also includes rights-of-way running through the 1796 Reservation; and any land title to which is either held in trust by the United States for the benefit the Tribe or individual or held by the Tribe or individual subject to restriction by the United States against alienation and over which the Tribe exercises jurisdiction.

15.01.040 Tribal Hemp Compliance Office

(a) Establishment of Office.

(1) The Tribe hereby establishes a Hemp Compliance Office ("HCO") within the Tribe's government structure to regulate hemp production and administer this chapter.

(b) Powers and Duties of HCO.

(1) Review, process and approve or deny all hemp production licenses.

(2) Develop policies, procedures, protocols and forms necessary to carry out this chapter.

(3) Issue hemp licenses and take any and all actions including, but not limited to, suspension, revocation, renewal or non-renewal of such licenses.

(4) Inspect and monitor hemp production operations, facilities and grow sites including sampling, testing and inspections.

(5) Collect and maintain all required records related to hemp production and submit all required reports to the Tribal Council, law enforcement agencies and the USDA.

(6) Investigate potential violations and wrongdoing associated with hemp production and report any potential criminal violations to the Tribe's General Counsel, law enforcement agencies and USDA.

(7) Enforce the regulations, impose and collect fees and/or penalties.

(8) Ensure that the Tribe's hemp program complies with all mandatory requirements in the Farm Bill and other applicable federal law.

(1) The HCO shall make all final administrative decisions under this chapter including, but not limited to, approval and denial of license applications, renewal and non-renewal of licenses, revocation or suspension of licenses and issuing administrative orders to enforce this chapter.

(2) The HCO will provide notice and an opportunity to be heard, including a hearing if necessary, to the affected party.

(3) The HCO will make its decisions based upon the administrative record presented and, where appropriate, issue its decision in writing.

(d) Tribal Court Review.

(1) Final decisions of the HCO may be appealed to the Saint Regis Mohawk Tribal Court (trial, not appellate division).

(2) The appeal shall be filed with the Tribal Court Clerk within thirty (30) days of the date of the HCO's decision.

(3) The Tribal Court will review the appeal based upon the administrative record and make its decision based upon the "arbitrary and capricious" standard of review.

(4) The Tribal Court's decision shall be final and non-appealable.

(e) Fees.

(1) The HCO may collect fees that are reasonably related to the costs of regulation including, but not limited to, application fees, the cost of pre-and post-harvest sampling and laboratory testing.

(2) If fees are not paid within 30 days when such fees are due that will be considered a violation of the producer's license and subject the producer to penalties and enforcement provisions contained herein.

15.01.050 Hemp Licenses

(a) General Requirements.

(1) No person shall engage in hemp production on Tribal Territory without first obtaining an approved hemp license. Failure to obtain a license will subject a person to penalties and enforcement provisions contained herein.

(2) The only persons eligible to obtain hemp licenses are Mohawk Tribal Members and Mohawk Tribal Member-Owned Businesses ("Tribal Member Business").

(3) The HCO will issue hemp producer licenses to cover all hemp production activities including, but not limited to, cultivation, extraction, obtaining seeds, handling hemp, storage, transportation and shipment of hemp to market.

(4) The HCO will develop application forms for all production license types and make those forms and other application information available to the public.

(b) License Applications.

(1) Applications for hemp licenses shall contain, at a minimum, the following information:

(A) The applicant's full name, residential address, telephone number, and email address, if an email address is available.

(B) Proof of Tribal Membership or, if a Tribal Member Business, proof that the entity is more than fifty percent (50%) owned and controlled by a Tribal Member.

(C) For Member Businesses, the full name of the business, the principal business location address, EIN number, the full name, title, and email address (if available) of each individual who will be a Key Participant in the business.

(D) Documentation of the applicant's valid legal right to the lands to be used for the proposed hemp site (this must be verified by the Saint Regis Mohawk Tribal Clerk).

(E) Street address, Lot number, legal description and, to the extent practicable, the Geospatial Location coordinates for each field, greenhouse, building, or site where Hemp will be produced, handled, processed or stored.

(F) If the applicant is engaged in hemp production in any other jurisdiction, information regarding that activity and a copy of applicant's license(s) in that jurisdiction.

(G) Proof of insurance that includes worker's compensation insurance for any employees, and general liability insurance.

(H) A business plan and/or operations plan that includes at a minimum the proposed acreage or greenhouse or indoor square footage to be used for hemp cultivation or used for processing, type of activity proposed (growing or extraction), description of facility, number of employees, security plan, description of all equipment, proposed customers for the hemp and source of seeds.

(I) Licenses will be issued for an initial three (3) year term and may be renewed for additional three (3) year terms upon reapplication by the producer and approval by the HCO.

(1) As part of the licensing process the producer shall execute a License Agreement and agree, at a minimum to:

(A) Comply with all requirements in this chapter and all orders issued by the HCO with the understanding that failure to comply shall constitute grounds for the suspension or termination of a license and require the HCO to report such failure to the USDA, or potentially, a law enforcement agency for further action.

(B) Submit all planting reports for both outdoor and indoor (greenhouse) sites within fifteen (15) days after every planting, including planting of seeds or propagules in the site that includes at a minimum the varieties of hemp planted, location ID as listed in the License Agreement and primary intended use of the harvest of each planting.

(C) Submit growing reports for each location ID as required by the HCO and hemp crop acreage to the USDA Farm Service Agency ("FSA") providing, at a minimum the street address and location ID and, to the extent practicable, the geospatial location for each site or greenhouse, acreage dedicated to the production of hemp, or greenhouse or indoor square footage dedicated to the production of hemp and license identifier.

(D) Give permission to the HCO, law enforcement agencies and USDA to enter onto the licensed site without cause, with or without advance notice to conduct an inspection or investigation, collect random samples of any Cannabis material or investigate other hemp production matters related to producer's facilities including access to all hemp and other Cannabis plants and seeds, whether growing or harvested, and all land, buildings, and other structures used for the production, handling, and storage of all hemp and other Cannabis plants and seeds.

(E) Agree to forfeiture and disposal or remediation, without compensation, of hemp that is produced in violation of this chapter.

(F) Not implement any change to the licensed site as designated in the License Agreement without prior written approval.

(G) Not interplant hemp with any other crop without express written permission of the HCO.

(H) Agree that any time hemp is in transit, a copy of the License and License Agreement shall be available for inspection upon request.

(I) Agree to immediately notify the HCO by telephone or electronically of any hemp-related interaction with a law enforcement agency and to follow-up to the HCO in writing within three (3) calendar days of that occurrence.

(J) Agree to pay all fees imposed under this chapter.

(K) Agree to pay for and submit to a Criminal Background Investigation.

(L) Contact the HCO and sampling agent to arrange for the collection of samples from the flower material from such Cannabis plants for THC concentration level testing at least 30 days prior to the anticipated harvest of hemp. The sampling cuts shall then be collected within 15 days of anticipated cultivation of the crop.

(M) Not harvest hemp prior to the hemp being sampled and receipt of permission to harvest from the HCO and tests of samples are taken to obtain specimens for the measurement of tetrahydrocannabinol (THC) content, which determine whether the specimens are hemp or marijuana.

(N) Not transport live hemp plants, viable seeds, leaf materials, or floral materials to unapproved locations including trade shows, county fairs, educational or other events, or any other address not listed on the producer's License Agreement without the prior written approval of the HCO.

(O) Not ship or transport, or allow to be shipped or transported, live hemp plants, cuttings for planting, or viable seeds from a variety that is currently designated by the HCO as a prohibited variety.

(P) Not allow the public to access hemp sites for activities such as a maze and not allow the unsupervised public on grow sites.

(Q) Agree to restrictions by the HCO regarding location of hemp grow sites and facilities near schools, playgrounds or other open public areas that may not be appropriate site locations. (r) Not transfer or assign the license to another person without the express written approval of the HCO.

15.01.060 Sampling and Inspections

(a) Sampling Requirements.

(1) Within 30 days prior to the anticipated harvest of cannabis plants, a producer shall have the HCO's sampling agent collect samples from the producer's crop for total delta-9 tetrahydrocannabinol concentration level testing. The sampling agent will be a person who is trained by the HCO to conduct sampling under USDA rules. Producers may not collect samples from their own growing facilities.

(2) Samples shall be obtained from the flowering tops of plants when flowering tops are present, and shall be approximately five to eight inches in length from the "main stem" (that includes the leaves and flowers), "terminal bud" (that occurs at the end of a stem), or "central cola" (cut stem that could develop into a bud) of the flowering top of the plant.

(b) Sampling Methods.

(1) The method used for sampling must be sufficient at a confidence level of 95 percent that no more than one percent of the plants in each lot would exceed the acceptable hemp THC level and ensure that a representative sample is collected that represents a homogeneous composition of the lot.

(2) Alternatively, the Tribe may adopt a performance-based method subject to USDA approval.

(3) The alternative method must have the potential to ensure, at a confidence level of 95 percent, that the cannabis plant species Cannabis sativa L. that will be subject to the alternative method will not test above the acceptable hemp THC level. The alternative method may consider one or more of the following factors:

(A) Seed certification process or process that identifies varieties that have consistently demonstrated to result in compliant hemp plants within Tribal Territory;

(B) Whether the producer is conducting research on hemp;

(D) Factors similar to those identified above in 3(a)-(c).

(1) During a scheduled sample collection, the producer or an authorized representative of the producer shall be present at the growing site if possible.

(2) Sampling agents shall be provided with complete and unrestricted access during business hours to all hemp and other cannabis plants (whether growing or harvested), to areas where hemp is grown and stored, and to all land, buildings, and other structures used for the cultivation, handling, and storage of all hemp and other cannabis plants, and all locations listed in the producer license.

(3) A producer shall not harvest the cannabis crop prior to samples being taken.

(d) Inspections.

(1) The HCO shall conduct annual inspections of a random sample of no less than 10% of all producers to verify that hemp is not produced in violation of this chapter.

15.01.070 Testing

(a) General Requirements.

(1) Laboratory testing of samples will be conducted so that the HCO is able to accurately identify whether the sample contains a total delta-9 tetrahydrocannabinol content concentration level that exceeds the acceptable hemp THC level are as follows.

(2) The testing procedure will include a validated testing methodology that uses post- decarboxylation or other similarly reliable methods. The testing methodology must consider the potential conversion of THCA in hemp into THC and the test result must report the total available THC derived from the sum of the THC and THCA content. Testi.g methodologies meeting the requirements of this section include, but are not limited to, gas or liquid chromatography with detection. The total THC concentration level shall be determined and reported on a dry weight basis.

(3) Any test of a representative sample resulting in higher than the acceptable hemp THC level shall be conclusive evidence that the lot represented by the sample is not in compliance with this part and shall be disposed of or remediated in accordance with Section 15.01.080.

(4) Samples of hemp plant material from one lot shall not be commingled with hemp plant material from other lots.

(b) Testing Laboratories.

(1) Laboratories conducting analytical testing for purposes of detecting the concentration levels of Total THC shall meet the following requirements:

(A) Laboratory quality assurance must ensure the validity and reliability of test results;

(B) Analytical method selection, validation, and verification must ensure that the testing method used is appropriate (fit for purpose), and that the laboratory can successfully perform the testing;

(D) Method performance specifications must ensure analytical tests are sufficiently sensitive for the purposes of the detectability requirements of this part; and

(E) Effective disposal procedures for non-compliant samples that do not meet the requirements of this part.

(F) Measurement of uncertainty (MU) must be estimated and reported with test results. Laboratories shall use appropriate, validated methods and procedures for all testing activities and evaluate measurement of uncertainty.

(G) Sample preparation of pre- or post-harvest samples shall require grinding of samples to ensure homogeneity of plant material prior to testing. Sample preparation may follow a procedure described by USDA.

(H) After December 31, 2022, the Tribe shall require that only laboratories registered with the DEA may conduct testing under this chapter.

(2) The Tribe will require testing laboratories to comply with USDA reporting requirements.

(3) Laboratories shall only report formal test results that are used to determine compliance under this chapter. Test results from informal testing conducted throughout the growing season shall not be reported to USDA.

15.01.080 Disposal and Remediation

(a) General Procedure.

(1) Cannabis plants exceeding the acceptable hemp THC level constitute marijuana, a schedule I controlled substance under the Controlled Substances Act (CSA), 21 U.S.C. 801 et seq., and producers must either use a DEA-registered reverse distributor or law enforcement to dispose of non-compliant plants or ensure the disposal of such cannabis plant on site at the farm or hemp production facility.

(2) Producers must notify the HCO of their intent to dispose of or remediate non-conforming plants and verify disposal or remediation by submitting required documentation.

(3) If a producer elects to perform remediation activities, an additional sampling and testing of the post-remediated crop must occur to determine THC concentration levels.

(b) Disposal Or Remediation Procedures.

(1) Disposal and remediation when a producer's plants are deemed non-compliant shall be conducted as follows:

(A) Disposal must be conducted either by using a DEA-registered reverse distributor or law enforcement; or on site at the farm or hemp production facility.

(B) The Tribe will provide procedures to verify the disposal or remediation of the cannabis plant. This may be done in the form of in-person verification by the HCO or alternative requirements that direct growers to provide pictures, videos, or other proof that disposal or remediation occurred successfully. (Disposal and remediation means are described at AMS's website).

(C) If a producer elects to perform remediation activities, an additional sampling and testing of the post-remediated crop must occur to determine THC concentration levels.

15.01.090 Violations and Enforcement

(a) Responsibility Of Producer After Laboratory Testing Is Performed.

(1) The producer shall harvest the crop no later than thirty (30) days after the date of sample collection.

(2) If the producer fails to complete harvest within thirty (30) days of sample collection, a second pre-harvest sample of the lot shall be required to be submitted for testing.

(3) Harvested lots of hemp plants shall not be commingled with other harvested lots or other material.

(4) Lots that meet the acceptable hemp THC level may enter the stream of commerce.

(5) Lots that do not meet the acceptable hemp THC level are subject to Section 15.01.090(b)-Section 15.01.090(e), below.

(6) Any producer may request additional pre-harvest testing if it is believed that the original total delta-9 tetrahydrocannabinol concentration level test results were in error. Additional testing may be conducted by the laboratory that conducted the initial test, or another laboratory.

(b) Non-Compliant Cannabis Plants.

(2) Producers must notify the HCO of their intent to dispose of or remediate non-conforming plants and verify disposal or remediation by submitting required documentation.

(3) If a producer elects to perform remediation activities, an additional sampling and testing of the post-remediated crop must occur to determine THC concentration levels.

(1) Violations of this part shall be subject to enforcement in accordance with the terms of this section.

(A) Negligent violations. Hemp producers are not subject to more than one negligent violation per calendar year. A hemp producer shall be subject to enforcement for negligently:

(i) Failing to provide an accurate legal description of land where hemp is produced;

(ii) Producing hemp without a license; and

(iii) Producing cannabis exceeding the acceptable hemp THC level. Hemp producers do not commit a negligent violation under Section 15.01.090(c)(1)(A) if they make reasonable efforts to grow hemp and the cannabis does not have a total THC concentration of more than 1.0 percent on a dry weight basis.

(B) Corrective action for negligent violations. For each negligent violation, the HCO will issue a Notice of Violation and require a corrective action plan from the producer. The producer shall comply with the corrective action plan to cure the negligent violation. Corrective action plans will be in place for a minimum of two (2) years from the date of their approval. Corrective action plans will, at a minimum, include:

(i) The date by which the producer shall correct each negligent violation;

(ii) Steps that will be taken to correct each negligent violation; and

(iii) A description of the procedures that will demonstrate compliance must be submitted to the HCO.

(C) Negligent violations and criminal enforcement. A producer who negligently violates this part shall not, as a result of that violation, be subject to any criminal enforcement action by any Federal, State, Tribal, or local government.

(D) Subsequent negligent violations. If a subsequent negligent violation occurs while a corrective action plan is in place, a new corrective action plan must be submitted with a heightened level of quality control, staff training, and quantifiable action measures.

(E) Negligent violations and license revocation. A producer that negligently violates the license 3 times in a 5-year period shall have their license revoked and be ineligible to produce hemp for a period of 5 years beginning on the date of the third violation.

(F) Culpable mental state greater than negligence. If the HCO determines that a producer has violated the terms of the license or of this part with a culpable mental state greater than negligence the HCO shall immediately report the licensee to:

(i) The U.S. Attorney General; and

(ii) The Tribe's General Counsel and Chief of Police; and

(iii) Paragraphs (a)(2) and (a)(3) of this section shall not apply to culpable violations.

(d) License suspension.

(1) The HCO may issue a notice of suspension to a producer if it receives some credible evidence establishing that a producer has:

(A) Engaged in conduct violating a provision of this part; or

(B) Failed to comply with a written order from the HCO related to negligence as defined in this part.

(2) Any producer whose license has been suspended shall not handle or remove hemp or cannabis from the location where hemp or cannabis was located at the time when the HCO issued its notice of suspension, without prior written authorization from the HCO.

(3) Any person whose license has been suspended shall not produce hemp during the period of suspension.

(4) A producer whose license has been suspended may appeal that decision in accordance with Section 15.01.040(d)

(5) A producer whose license has been suspended and not restored on appeal may have their license restored after a waiting period of one year from the date of the suspension. If the license was issued more than three years prior to the date of restoration, the producer shall submit a new application and criminal history report to the HCO.

(6) A producer whose license has been suspended may be required to provide, and operate under, a corrective action plan to fully restore their license.

(e) License Revocation.

(1) The HCO shall immediately revoke the license of a producer if such producer:

(A) Pleads guilty to, or is convicted of, any felony related to a controlled substance; or

(B) Made any materially false statement with regard to this part to the HCO or its representatives with a culpable mental state greater than negligence; or

(C) Is found to be growing cannabis exceeding the acceptable hemp THC level with a culpable mental state greater than negligence or negligently violated this part three times in five years.

15.01.100 Reporting and Recordkeeping

(a) Hemp Producer Report.

(1) The Tribe will submit to the USDA, by the first of each month, a report providing the contact information and the status of licenses or other authorization issued for each producer covered under this chapter. If the first of the month falls on a weekend or holiday, the report is due by the first business day following the due date. The report will be submitted using a digital format compatible with USDA's information sharing systems, whenever possible.

(2) The Tribe's report will contain the following information:

(A) For each new producer who is an individual and is licensed or authorized under this chapter, the full name of the individual, license or authorization identifier, business address, telephone number, and email address (if available).

(B) For each new producer that is an entity and is licensed or authorized under this chapter, the full name of the entity, the principal business location address, license or authorization identifier, and the full name, title, and email address (if available) of each employee for whom the entity is required to submit a criminal history record report.

(C) For each producer that was included in a previous report and whose reported information has changed, the previously reported information and the new information.

(D) The status of each producer's license or authorization.

(E) The period covered by the report.

(F) Indication that there were no changes during the current reporting cycle, if applicable.

(b) Hemp Disposal And Remediation Report.

(1) If a producer has produced cannabis exceeding the acceptable hemp THC level, the cannabis must be disposed of or remediated.

(2) The Tribe shall submit to USDA, by the first of each month, a report notifying USDA of any occurrence of non-conforming plants or plant material and providing a disposal or remediation record of those plants and materials. This report will include information regarding name and contact information for each producer subject to a disposal or remediation during the reporting period, and date disposal or remediation was completed. If the first of the month fall on a weekend or holiday, reports are due by the first business day following the due date.

(3) The report shall contain the following information:

(A) Name and address of the producer.

(B) Producer license or license identifier.

(C) Location information, such as lot number, location type, and geospatial location or other location descriptor for the production area subject to disposal or remediation.

(D) Information on the agent handling the disposal or remediation.

(E) Disposal or remediation completion date.

(F) Total acreage.

(1) The Tribe will submit an annual report to USDA by December 15 of each year that contains the following information:

(A) Total planted acreage.

(B) Total harvested acreage.

(d) Test Results Report.

(1) Each producer must ensure that the laboratory that conducts the test of the samples from its lots reports the test results for all samples tested to the HCO. Informal testing conducted throughout the growing season for purposes of monitoring THC concentration do not need to be reported to the HCO.

(2) The test results report shall contain the following information:

(A) Producer's license or license identifier.

(B) Name of producer.

(D) Lot identification number for the sample.

(E) Name of laboratory and, after December 31, 2022, the DEA registration number of laboratory for testing.

(F) Date of test and report.

(G) Identification of a retest.

(H) Test result.

(e) Producers Report To FSA.

(1) All licensed producers shall report hemp crop acreage to the FSA and provide, at a minimum, the following information:

(2) Street address and, to the extent practicable, geospatial location for each lot or greenhouse where hemp will be produced. If an applicant operates in more than one location, or is producing under multiple licenses, production information shall be provided for each location.

(3) Acreage dedicated to the production of hemp, or greenhouse or indoor square footage dedicated to the production of hemp.

(4) License or authorization identifier in a format prescribed by USDA.

(f) Procedure To Collect And Share Information with USDA.

(1) The Tribe agrees to the following procedure to collect and share information with the USDA to comply with 7 U.S.C. §1639q(d).

(A) All producers will report their crop acreage to the FSA consistent with the requirements of 7 CFR 990.7.

(B) The HCO will assign a license identifier for each producer in a format prescribed by the USDA.

(C) All producers will report the total acreage of hemp planted, harvested, and, if applicable, disposed or remediated. That information will be collected by the Tribe and reported to the AMS.

15.01.110 Miscellaneous

(a) Certification By Tribe

(1) The Tribe certifies that it has the resources and personnel to carry out the practices and procedures described in this chapter.

(b) Amendment Of Regulations

(1) This chapter may be amended by the Tribal Council under the provisions of the Tribal Procedures Act that includes notice to, and review by, the Community.

(1) This chapter shall be effective upon it adoption by the Tribal Council and approval by the Secretary of the United States Department of Agriculture.

(d) Severability

(1) The provisions in this chapter shall be severable and if any part or provision shall be held void by any Court the decision so holding shall not affect any of the remaining parts.

Chapter 15.02 Adult Use Cannabis Ordinance

Subchapter 1 General Provisions

15.02.010 Title

This chapter shall be known as the "Saint Regis Mohawk Tribe Adult Use Cannabis Ordinance".

15.02.020 Purpose

(a) This chapter establishes rules and regulations governing commercial use and activity of "Adult Use Cannabis" (recreational or non-medical cannabis) (hereinafter "AUC" or "Cannabis") including, but not limited to, cultivation, processing and sale on tribal territory. No persons shall engage in any commercial AUC activities unless licensed under this chapter.

(b) This chapter allows adult, tribal members to grow and possess a limited number of Cannabis plants for their own, non-commercial, personal use at their own residences on tribal territory.

(c) This chapter consolidates Tribal regulation of all cannabis activities including but not limited to hemp, medical cannabis and AUC, within one Tribal board, the Tribal Cannabis Control Board ("CCB"), and one Tribal regulatory office, the Cannabis Compliance Office ("CCO").

(d) This chapter includes appropriate fees on commercial AUC activities to fund tribal oversight and regulation and to fund tribal member programs and services.

15.02.030 Authority

(a) The Tribe's authority to adopt this chapter is based upon the Tribal Procedures Act, as amended, and the Tribe's inherent sovereign power to: (1) enact laws governing commercial activity within its territory; and (2) adopt regulations to protect the health, safety and general welfare of tribal members.

15.02.040 Federal Guidance

(a) The U.S. Department of Justice has previously issued guidance and policy regarding the use and sale of cannabis by tribes on their territory. The guidance and policy advises tribes to include in their cannabis programs provisions to prevent the distribution of cannabis to minors; prevent the diversion and trafficking of cannabis, especially to criminal elements such as gangs and cartels; and prevent drugged driving and other adverse public health consequences associated with cannabis use.

(b) This chapter provides a robust regulatory system that addresses these issues. It requires use of a tracking system to record cannabis transactions on tribal territory from cultivation to sale. It contains mandatory rules on sales to minors. And it includes provisions protecting community health and safety at least as robust as those imposed by New York State with respect to AUC sales.

15.02.050 Other Laws Unaffected

(a) Nothing in this chapter is intended to allow driving under the influence of cannabis or driving while impaired by cannabis or to prevent enforcement of any laws imposing penalties for driving under the influence or while impaired.

(b) Nothing in this chapter is intended to limit any privileges or rights of a medical marijuana patient, primary caregiver or registered or licensed entity under the Tribe's Medical Marijuana Ordinance.

(c) Nothing in this chapter shall affect the ability of any employer on tribal territory to enact policies restricting the use of cannabis by employees.

(d) All existing authority of the Tribe shall remain in full force and effect, and nothing in this chapter repeals or limits the Tribe's authority to impose penalties or initiate punitive proceedings before or after its effective date.

15.02.060 Definitions

(a) When used in this chapter, unless the context clearly requires otherwise:

(1) "Adult Use Cannabis" or "AUC" means cannabis intended for non-medical use by persons 21 years of age or older.

(2) "Business" means a location at which a licensee is licensed as a cultivator, processor or retailer or any other type of Tribally licensed cannabis-related business.

(3) "Cannabis" refers to the plant of the genus cannabis, whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, excluding hemp or its derivatives unless clearly required by context.

(4) "Cannabis Compliance Office" or "CCO" means the Tribal regulatory office established in Subchapter Two of this chapter.

(5) "Cannabis Control Board" ("CCB") means the Tribal Board established in Subchapter Two of this chapter.

(6) "Concentrate" means the resin extracted from any part of the plant of the genus cannabis.

(7) "Consumer" means a person, twenty-one years of age or older, who purchases approved AUC or AUC products for personal use, but not for resale to others.

(8) "Cultivation" means the planting and growing of AUC under a license issued in this chapter either indoors or outdoors that includes the related activities such as cloning, harvesting, drying, curing, grading and trimming of cannabis.

(9) "Edible cannabis product" or "edible" means any foodstuff, beverage, tincture, oil, or other product containing cannabis or cannabis extract and intended for oral consumption.

(10) "Inherently hazardous substance" means a liquid chemical, compressed gas or commercial product that has a flash point at or lower than 38 degrees Celsius or 100 degrees Fahrenheit, including, but not limited to, butane, propane and diethyl ether. "Inherently hazardous substance" does not include any form of alcohol or ethanol.

(11) "Key participant" means a sole proprietor, a partner in partnership, a member or manager in a limited liability company or a person with executive managerial control in a corporation. A person with executive managerial control includes persons such as a chief executive officer, chief operating officer, chief financial officer, limited liability company manager, or other positions regardless of title with authority to direct or influence the financial and business affairs of the enterprise.

(12) "Law enforcement agency" means the Saint Regis Mohawk Tribal Police Department and any federal, state, or local law enforcement agency that may also have jurisdiction over an activity under this chapter.

(13) "Operating plan" means a set of documents submitted by an applicant detailing its operations, and which, when approved by the CCB, shall be enforceable by the CCO.

(14) "Plant" means a living plant of the Cannabis genus (sativa and indicia species), excluding hemp, capable of producing its own food through photosynthesis and is in a grow medium.

(15) "Premises" or "licensed premises" shall refer to where a licensee's cannabis activity occurs.

(16) "Processor" means a licensee that processes (manufactures), packages and labels AUC and AUC cannabis products for sale in licensed cannabis retail stores.

(17) "Products" or "cannabis products" means any concentrated cannabis, oils, or cannabis-infused or extracted products, or products which otherwise contain or are derived from cannabis, authorized for sale to, and for use by, a cannabis consumer as approved by the Tribe.

(18) "Residence" means a fully enclosed permanent structure used or intended for human occupancy. Recreational vehicles, trailers, motorhomes, tents or other vehicles or structures which are used, designed or intended as temporary housing shall not constitute a residence for purposes of this chapter.

(19) "Retail store" or "store" means a facility licensed by the Tribe in which approved AUC and AUC products are sold and offered for sale to consumers.

(20) "Saint Regis Mohawk Tribal Council" means the elected Tribal Council of the Saint Regis Mohawk Tribe consisting of three elected Chiefs and three elected Sub Chiefs.

(21) "Saint Regis Mohawk Tribal Police" means the law enforcement department for the Saint Regis Mohawk Tribe with police authority over tribal territory.

(22) "Saint Regis Tribal Court" means the trial level court under the Tribal Court system that consists of the Chief Judge and associate Tribal Court members as established under tribal law.

(23) "Seed" means the fertilized, un-germinated, matured ovule, containing an embryo or rudimentary plant, of a cannabis plant that is flowering.

(24) "Seedling" means a cannabis plant that has germinated and has not flowered and is not harvestable.

(25) "Sensitive Sites" means the following areas that are protected under this chapter by certain proximity provisions: tribal government offices, recreation centers, churches and places of worship, public parks, libraries, game arcades, elementary schools, secondary schools, playgrounds, youth centers such as the Akwesasne Boys and Girls Club, athletic fields and other site designated by the CCO.

(26) "Serious felony" means an applicant is not currently subject to and has not discharged a sentence for a conviction of an offense under state or federal law or the law of any other jurisdiction within the past five (5) years involving: (1) manufacturing, distributing, or possessing with intent to manufacture or distribute. a controlled substance other than cannabis, for which a maximum term of imprisonment of ten years or more is prescribed by law; or (2) a "violent felony" for which a minimum sentence term of one and a half years is prescribed by law.

(27) "THC" means Delta-9-tetrahydrocannabinol; Delta-8-tetrahydrocannabinol and the optical isomers of such substances.

(28) "Tribal Cannabis Exchange" ("TCE") means the entity responsible for allotting quantities of cannabis and cannabis extract to Processors; allotting as necessary quantities of prepackaged cannabis and cannabis products to Retail Stores; establishing as necessary prices for cannabis and cannabis products transferred through the exchange; and issuing revenue stamps to be affixed to cannabis and cannabis products before they are offered for sale.

(29) "Tribal Member" or "Member" means a person who is enrolled in the Tribe under the Tribe's Membership Code or a person who is eligible to be enrolled regardless of where they reside as verified by the Tribal Clerk.

(30) "Tribal Member-Owned Business" or "Tribal Member Business" means an entity that is more than fifty percent (50%) owned and controlled by a tribal member. "Controlled" means to have controlling interest whereby a person holds a majority of a company's voting stock, giving them significant influence over any corporate actions. A person or group of persons having a controlling interest will be able to direct the course of a company and make strategic and operational decisions. A non-tribal member owning an interest in a Tribal Member-Owned Business may not avoid being deemed to have "control" through the use of management agreements, license agreements or other instruments, agreements or arrangements designed to grant control to non-tribal members.

(31) "Tribal tracking system" or "system" means a database approved or established by the Tribe that licensees will be required to use to track and account for cannabis transactions and activities on tribal territory.

(32) "Tribal territory" means all lands with the boundaries of the Treaty of 1796 and all other lands over which the Tribe has jurisdiction.

(33) "Tribe" shall mean the Saint Regis Mohawk Tribe, a federally recognized Indian tribe located in Akwesasne, New York. References to "Tribe" shall also include the Tribe's Cannabis Compliance Office and/or Cannabis Control Board.

Subchapter 2 Regulation by the Tribe

15.02.070 Cannabis Control Board

(a) Creation of Board. The Tribal Council establishes the Saint Regis Mohawk Tribal Cannabis Control Board ("CCB") to: (1) provide oversight on behalf of the Tribal Council over the Tribe's Cannabis Compliance Office on all cannabis regulatory matters; (2) to issue cannabis licenses and render other administrative decisions regarding cannabis licensure; and (3) to carry out any other oversight and regulatory powers delegated by the Tribal Council.

(b) CCB Powers and Duties. The CCB's duties and powers shall include, but not be limited to:

(1) Accept, review, approve, or disapprove cannabis license applications including those required under this chapter including, but not limited to, applications for cultivation, processing and retail store licenses;

(2) Adopt rules to impose and collect any fees or fines necessary to the regulation of cannabis including fees imposed under this chapter;

(3) Adopt cannabis regulations and rules after consultation with the CCO.

(4) Approve the issuance of cannabis orders recommended by the CCO under Tribal Ordinances, including this chapter, including but not limited to: orders to cease and desist, closures of facilities, suspension and revocation of licenses as necessary to protect public safety;

(5) Monitor the regulation of all activities of cannabis licensees;

(6) Keep accurate records of all matters within the CCB's duties.

(c) Board Composition. The CCB shall have five (5) full members and two (2) alternate members (referred collectively as "members"). Members shall be appointed by the Tribal Council and shall serve staggered terms.

(d) Qualifications. Members of the Board shall have the following qualifications:

(1) They must be at least twenty-five (25) years old (on date of appointment);

(2) They must possess good moral character and not have been convicted of a serious crime as defined in the Tribe's Election and Referendum Ordinance, as amended;

(3) They must be willing to take, and must pass, a background check administered by the Tribe and/or Tribal Police;

(4) They must be willing and capable of maintaining communications through technology (email, texts, mobile phone) so as to be accessible to the Board;

(5) At least three (3) full members must be Tribal Members;

(6) At least three (3) full members must have knowledge and experience in any one of the following areas:

(A) business experience in the cannabis industry;

(B) specialized knowledge or education in a cannabis field (including but not limited to medicine, pharmacology; laboratory testing; agriculture, regulation or law);

(D) public health and safety.

(e) Alternate Qualifications.

(1) Alternate members must be tribal members and are not required to have any special qualifications.

(f) Other Board Requirements.

(1) No member of the CCB shall actively participate in, or be employed by, a cannabis business that is regulated by the Tribe under this or other cannabis Ordinance or law.

(2) CCB members will be entitled to compensation according to the standard schedule of fees and compensation provided for tribal boards, committees and commissions.

(3) The CCB will adopt their own Bylaws and will nominate a Chairperson by motion and majority vote for a one (1) year term or until a successor is elected. The Chairperson will preside over all meetings and perform all duties of that office as required under approved Bylaws. The CCB will also nominate and elect other Officers (Vice-Chair, Treasurer, Secretary) with duties and requirements to be set forth in approved By-Laws. The CCB will schedule and hold regular meetings.

(4) Members of CCB may be removed by Tribal Council, either by the Council itself or upon recommendation by the Board. They may be removed based upon violation of any provision of this, or other cannabis Ordinance, failure to perform duties as a member, excessive absences from meetings, failure to recuse oneself due to a conflict of interest or conduct unbecoming a member.

(5) Member vacancies will be filled by the Tribal Council under the same procedure used for appointment. Members appointed to fill vacancies will serve the remainder of the vacant seat.

(g) The CCB will provide regular reports to the Tribal Council summarizing, among other things, their official actions, activities, investigative reports, and reports received from licensed businesses to keep the Tribal Council fully informed as to the status of their activities.

15.02.080 Cannabis Compliance Office

(a) Creation of Office. The Tribal Council establishes the Saint Regis Mohawk Tribal Cannabis Compliance Office ("CCO") to provide day-to-day regulation of all cannabis activities on Tribal territory.

(b) Powers and Duties. The powers and duties of the CCO shall include but not be limited to:

(1) Handle all aspects of cannabis license applications process, including providing notice to the community about application forms, deadlines for applications, in-take of applications, review of applications and providing recommendations to the CCB concerning license applications;

(2) Assist the CCB in developing regulations implementing cannabis laws, including this chapter; and policies, procedures, protocols and forms necessary for all cannabis regulation and administration;

(3) Inspect and monitor adult use cannabis businesses, operations and facilities for regulation and enforcement;

(4) Work with law enforcement and other appropriate agencies to investigate violations of this chapter and all cannabis laws, take or recommend appropriate enforcement actions; and report criminal activity to appropriate law enforcement agencies;

(5) Ensure that all Tribal cannabis laws comply with requirements under tribal and federal law;

(6) Develop and administer a tribal tracking system to record, collect and track cannabis activities and data on Tribal territory;

(7) Report on a regular basis to the CCB and the Tribal Council, the Tribal Police Department and other appropriate governmental and law enforcement agencies; and

(8) With the approval of the CCB, retain consultants, advisors and agents to assist with any of the duties described above, except that the CCO may not contract with any person having an ownership interest in, or control of, any Cultivator, Processor, or Retail Store licensed by the Tribe.

15.02.090 Tribal Cannabis Exchange

(a) Creation of Exchange. The Tribal Council establishes the Saint Regis Mohawk Tribal Cannabis Exchange ("TCE") to ensure that Processor licensees and Retail Store licensees have access to cannabis, cannabis extract, and cannabis products, as applicable, at prices established by the CCO according to objective standards. Upon the effective date of this chapter, the CCO shall establish the TCE within the CCO.

(b) Powers and Duties. The powers and duties of the TCE shall include but not be limited to:

(1) Determine, through consultation with Processors and Retail Stores, the demand for bulk cannabis flower and trim, cannabis extract, prepackaged cannabis products, and prepackaged flower;

(2) Establish prices for bulk and prepackaged cannabis, cannabis extract, and other cannabis products sold through the exchange, which shall be not less than 80 percent of published wholesale prices for adult use cannabis and cannabis products nationwide, or, if available, New York State;

(3) Set quantities, on a quarterly basis, of bulk flower and trim that a Cultivator must make available to Processors at the price determined by the TCE and prepackaged flower that a Cultivator must make available to Retail Stores at the price determined by the TCE, except that the total amount shall not exceed the quarterly amount in the Cultivator's approved operating plan;

(4) Set quantities, on a quarterly basis, of bulk cannabis extract that a Tier II Processor must make available to other Processors at the price determined by the TCE and prepackaged cannabis products that a Processor must make available to Retail stores at the price determined by the TCE, except that the total amount shall not exceed the quarterly amount in the Processor's approved operating plan;

(5) Monitor Cultivators and Processors to determine compliance with their obligations under their approved operating plans;

(6) Allot bulk cannabis or cannabis extract to Processors for purchase at prices determined by the CCO;

(7) Allot prepackaged cannabis and cannabis products to Retail Stores at prices determined by the CCO; and

(8) Collect per-gram fees and issue revenue stamps that shall be affixed to cannabis and cannabis products before transfer to a Retail Store.

Subchapter 3 AUC Business Licenses

15.02.100 Cannabis Business Licenses

(a) This chapter shall authorize the issuance of business licenses that will include, but not be limited to:

(1) AUC Cultivation licenses;

(2) AUC Processing licenses;

(3) AUC Retail store licenses; and

(4) AUC Consumption lounge licenses

(5) Any other types of AUC business licenses as deemed necessary by the Tribe, including without limitation nursery cultivation, microbusinesses, transportation and testing or testing sample collector licenses.

(b) At its discretion, the CCO, after consultation with the CCB, may issue combined licenses such as Cultivation/Processing or Retail/Processing provided that all required application information is provided, and fees paid.

15.02.110 Nature of Business Licenses

(a) All licenses are issued as a revocable privilege and not as a matter of right to licensees.

(b) The number of business licenses issued overall will be determined by the Tribe based upon factors such as market conditions, market or product saturation, increase in crime, abuse of license privileges; and other relevant factors.

15.02.120 License Term

All licenses shall have a term of five (5) years, unless revoked pursuant to this chapter, and may be renewed through a renewal application process established by the CCO.

15.02.130 Threshold Eligibility Requirements

(a) As a threshold, in order to be considered for a business license a person must:

(1) Be a tribal member;

(2) Be 21 years old or older;

(3) Not have been convicted of a serious felony as defined in this chapter

(b) If a tribal member-owned business, tribal members must own and control more than 50% of the business, and all persons owning or controlling the business must:

(1) Be 21 years old or older; and

(2) Not have been convicted of a serious felony, as defined in this chapter.

15.02.140 Cannabis Retailers in Operation Prior to Licensing

(a) Any person or business operating a business that is open to the public and is selling cannabis prior to obtaining a license shall be deemed ineligible to obtain a license, unless the person or business:

(1) Ceases operation within 48 hours of the enactment of this chapter;

(2) Remains closed to the public until a license is obtained; and

(3) Pays an additional fee determined by the CCO, which shall be no greater than $300 for each day the business was open to the public without a license.

(b) The CCB has the authority to provide a waiver of Section 15.02.140(a) on a case-by- case basis if circumstances warrant such a waiver.

Subchapter 4 Licenses Applications

15.02.150 Information Required for Pre-Clearance

(a) Applicants for all types of business licenses will be required to submit, at a minimum, the following basic information to obtain pre-clearance to operate an AUC business.

(1) Name, date of birth, Social Security Number, residential address, telephone number (mobile included), and email address;

(2) For member-owned businesses, the full name of the business, the principal business location address, EIN number, the full name, date of birth, title, telephone number (mobile included), and email address of each individual who will be a key participant in the business;

(3) Proof of tribal membership or, if a member-owned business, proof that the entity is more than fifty percent (50%) owned and controlled by a tribal member;

(4) A Criminal History Report covering the past five (5) years for each individual member;

(5) For member-owned businesses, copies of business organization documents such as articles of incorporation, LLC operating agreement, partnership agreement, shareholder agreements, management and license agreements and any other agreement which affects or relates to ownership and control of a member-owned business;

(6) Type of license(s) for which application will be made;

(7) Financial statements of the applicant and key participants

(8) Location of proposed site including GPS coordinates for the site;

(9) Any deed, lease or agreement establishing applicant is entitled to possession of the premises; and

(10) Other information as required by the CCO.

(b) Each applicant for pre-clearance shall agree to participate in the TCE if asked to do so.

(d) The CCO shall not accept an application for a Cultivation license, Processing license, or Retail Store license from an applicant who has not received pre-clearance from the CCO.

15.02.160 Cultivation Applications

(a) Applicants for Cultivation licenses shall provide an operating plan, which shall address, at a minimum:

(1) Whether the facility will be an indoor or outdoor facility (or both);

(2) A legible and accurate diagram of the planned cultivation facility or facilities (whether indoor, outdoor or both)

(3) Applicant's plan for security and surveillance of the site(s);

(4) Information on employees (number, names, and identification of key employees);

(5) Plan to abate noise, odors and hazardous wastes;

(6) The number of plants the Cultivator will grow;

(7) Agree to follow the TCE requirements in this chapter and in CCB regulations; and

(8) Any other information required by the CCO.

(b) The CCO shall, on the effective date of this chapter, begin to accept applications for Cultivation licenses from any applicant who has received pre- clearance.

(c) A Cultivation licensee may apply to change tiers by submitting a revised operating plan and the difference in application and licensing fees, prorated for the time remaining on the license.

(d) In determining whether to grant a Tier III Cultivation license, the CCB may consider factors including but, not limited to:

(1) Unmet demand for cannabis among licensed Processors and Retailers;

(2) Commitment to participate in the TCE; and

(3) Needs of the applicant for its own extraction and processing.

15.02.170 Processing Applications

(a) Applicants for Processing licenses shall provide an operating plan, which shall address, at a minimum:

(1) A legible and accurate diagram of the planned processing facility;

(2) Whether the facility will be located within or in connection with a cultivation facility;

(3) Applicant's plan for security and surveillance of the site(s);

(4) Information on employees (number, names, and identification of key employees);

(5) Plan to abate noise, odors and hazardous wastes;

(6) A description of the types of cannabis products the applicant proposes to manufacture, including whether the applicant proposes to extract cannabis, and if so, complete descriptions of methods and equipment;

(7) If the applicant proposes to extract cannabis, an agreement to sell up to 30 percent of extract produced through the TCE, if directed by the TCE;

(8) An agreement to sell up to 30 percent of cannabis products produced through the TCE, if directed by the TCE; and

(9) Any other information required by the CCO.

(b) The CCO shall begin to accept applications for Processing licenses no later than 30 days after the effective date of this chapter.

(c) After 180 days of operation, a Processing licensee may apply to change tiers by submitting a revised operating plan and the difference in application and licensing fees, prorated for the time remaining on the license.

15.02.180 Retail Store Applications

(a) Applicants for Retail Store licenses shall provide an operating plan, which shall address, at a minimum:

(1) A legible and accurate diagram of the planned store, including areas that are open to members of the public who are 21 years of age or older;

(2) Proof that the store is not located within 500 feet of any sensitive sites;

(3) Whether the store has its own separate ingress and egress as required by this chapter;

(4) Applicant's plan for security and surveillance of the store;

(5) Information on employees (number, names, and identification of key participants); and

(6) Any other information required by the CCO.

(b) The CCO shall begin to accept applications for Retail Store licenses within 30 days of the effective date of this chapter.

15.02.190 Consumption Lounge Applications

(a) Applicants for Consumption Lounge licenses shall provide an operating plan, which shall address, at a minimum:

(1) A legible and accurate diagram of the planned lounge, including areas that are open to members of the public who are 21 years of age or older;

(2) Proof that the lounge is not located within 500 feet of any sensitive sites;

(3) Proof that the Applicant has a Retail license

(4) Whether the lounge has its own separate ingress and egress as required by this chapter;

(5) Applicant's plan for security and surveillance of the lounge including prevention of underage sales;

(6) Applicant's plan for employee training;

(7) Information on employees (number, names, and identification of key participants); and

(8) Any other information required by the CCO.

(b) The CCO shall begin to accept applications for Consumption Lounge licenses within 30 days of the effective date of this chapter.

Subchapter 5 AUC License Approval

15.02.200 Initial Review by Cco

(a) Role of the CCO. The CCO shall be responsible for processing license application including, but not limited to:

(1) Preparation of application forms;

(2) Providing notice to the community about application forms, deadlines for applications;

(3) In-take and review of applications to make sure they are complete and application fees have been paid;

(4) Making pre-clearance determinations; and

(5) Providing recommendations to the CCB concerning approval or denial of license applications.

15.02.210 Role of the Ccb

(a) The CCB shall be responsible for processing AUC license applications including, but not limited to:

(1) Receipt of the completed applications from the CCO;

(2) Review by the CCB of the applications;

(3) Scheduling any meeting with applicants to discuss the applications and obtain additional information;

(4) The CCB will formally meet within 30 days of receipt of a completed application to decide whether to approve or deny an application;

(5) The CCB will issue a written decision via letter to applicant.

15.02.220 Tribal Court Review

(a) Final decisions of the CCB may be appealed by an applicant to the Saint Regis Mohawk Tribal Court (trial level).

(1) The appeal shall be filed with the Tribal Court Clerk within thirty (30) days of the date of the CCB's final decision.

(2) The Tribal Court shall review the appeal based upon the administrative record before the CCB.

(3) The Tribal Court will base its decision upon the "arbitrary and capricious" standard of review.

(A) The arbitrary and capricious standard of review means that the CCB's decision will only be set aside only if there has been a clear error of judgment.

(B) Review under the standard is narrow and the reviewing court may not substitute its judgment for that of the CC.

(C) The Tribal Court must determine whether the decision was based on a consideration of the relevant factors and whether there was clear error.

(4) The Tribal Court's decision shall be final and non-appealable.

15.02.230 Conditional Licenses

(a) The CCO and CCB may decide to issue conditional licenses to applicants if that is deemed necessary. The applicant still must complete and submit a complete application form. The award of a conditional licenses will contain terms that must be satisfied before a permanent license is granted.

Subchapter 6 AUC License Fees

15.02.240 Application Fees

(a) There shall be a non-refundable application fee for pre-clearance. This fee shall be $100 per individual listed on the application.

(b) There shall be a non-refundable application fee for all licenses issued under this chapter. The initial application fees for licenses shall be:

(1) Cultivation License Application Fees:

Type of Cultivation Facility	Application Fees
Tier I 0-250 plants	$500
Tier II 251-500 plants	$500
Tier III Over 500 plants	$1,500

(1) Processor License Application Fees:

Type of Processor Facility	Application Fees
Tier I (Preparation of edibles only; no extraction permitted)	$250
Tier II (Preparation of all products permitted by the CCO, including the use of solvents in extraction)	$500

(2) Retail Store License Application Fees

All retail stores

$2,500

(3) Consumption Lounge Application Fees

All Consumption Lounges

$2,500

15.02.250 Annual License Fees

(a) Annual License fees shall be paid by all license holders and shall be paid through flat-rate annual payments of fees as set forth below. Cultivators and Processors shall also pay per-gram fees on any cannabis or cannabis products and affix the appropriate revenue stamps to the cannabis or cannabis products before transferring the cannabis or cannabis products to the Retail Store.

(1) Flat Rate Fees

The CCO shall have discretion to accept the payment of flat rate fees in monthly or quarterly installments.

(A) Cultivation

Type of Cultivation Facility	Fee
Cultivation Tier I	$1,000
Cultivation Tier II	$2,500
Cultivation Tier III	$5,000

(B) Processing

Type of Processor Facility	Fee
Tier I	$1,000
Tier II	$3,500

Type of Store	Fee
All retail stores	$5,000

(D) Consumption Lounge

Type of Lounge	Fee
All Consumption Lounges	$5,000

(2) Per-Gram Fees

(A) Fee schedule

Type of Product	Fees
Cannabis Flower	$.50/gram
Concentrate or vaporizer cartridges	5% of sales
Edibles (including tinctures, oils, or beverages tested by a certified testing facility)	5% of sales
Tinctures, oils, or beverages (untested)	$14.00/fluid ounce
Topical (ointment or cream)	$1.00/fluid ounce
Transdermal patches (tested)	$1.75/100 mg of THC
Transdermal patches (untested)	$1.00/patch

(3) Single Serving Products (sold in Consumption Lounges)

(A) The CCO has the authority to amend the fee schedule provided in this section with advanced notice to licensees.

Type of Product	Fees
Cannabis Flower	$.50/gram
Concentrate or vaporizer cartridges	5% of sales
Edibles (including tinctures, oils, or beverages tested by a certified testing facility)	5% of sales
Tinctures, oils, or beverages (untested)	$14.00/fluid ounce
Topical (ointment or cream)	$1.00/fluid ounce
Transdermal patches (tested)	$1.75/100 mg of THC
Transdermal patches (untested)	$1.00/patch

(B) The TCE shall collect this fee from Cultivators and Processors before issuing revenue stamps and before any cannabis or cannabis products are transferred to a Retail Store. For licensees holding multiple licenses, this shall include the transfer of cannabis or cannabis products to the site used as a Retail Store.

(C) Cultivators and Processors may include per grams fees in their sales to Retail Stores, and, if applicable, may add per-gram fees to the prices established by the TCE.

(b) The CCO with the approval of the CCB shall have authority to:

(1) Impose additional fees;

(2) Adjust fees from one level to another based upon plant count or production amounts;

(3) Revise the application fee amounts for licensees for new and renewed licenses.

Subchapter 7 Retail Sale Operations

15.02.260 Store Sales Restrictions

(a) Cannabis Retail stores may only offer for sale and sell cannabis, cannabis products and other products listed in this section or approved by the CCO.

(b) Stores may not offer for sale or sell alcohol.

(c) Cannabis or cannabis products may not be consumed within the store premises unless the Cannabis Retail store has an additional consumption lounge license and the consumption lounge is completely separated from the remainder of the premises by solid partitions without openings other than doors.

15.02.270 Approved Products

(a) A cannabis retail store will be permitted to sell:

(1) Flower

(2) Pre-roll

(3) Concentrate

(4) Vaporizer cartridges

(5) Edible cannabis products (including food, tinctures, oils, and beverages)

(6) Topical products (including ointment, creams, and transdermal patches)

(7) Other cannabis products approved by the Tribe

(8) Other products not containing cannabis as permitted by the CCO.

15.02.280 Prohibited Sales

A retail store may not:

(a) Sell cannabis and cannabis products to any person under the age of 21.

(b) Make sales that exceed the following single day transaction amounts to any particular purchaser:

Product	Single day transaction limit per purchaser
Cannabis	3 ounces
Cannabis concentrate, including vaporizer cartridges	24 grams

For purposes of determining the amount of cannabis concentrate sold, edible cannabis products shall be considered to have 1 gram of cannabis concentrate per 100 mg of THC. The CCO may by rule establish other equivalency amounts for different types of cannabis products.

(c) Sell or offer for sale cannabis and cannabis products unless obtained from a processor, distributor or cultivator licensed by the CCO.

(d) Sell or offer for sale cannabis and cannabis products using: (1) a vending machine; or (2) an internet sales platform.

(e) Sell or offer for sale cannabis or cannabis products to a visibly intoxicated person.

(f) Sell or offer for sale cannabis or cannabis products that do not meet the tracking, packaging, labeling and testing requirements in this chapter; or

(g) Sell or offer for sale cannabis or cannabis products unless revenue stamps have been affixed to the product.

15.02.290 Verification of Age of Consumers

(a) Prior to any sale of cannabis or cannabis products, the licensee shall verify that the individual is 21 years of age or older by means of an approved form of government-issued photographic identification containing a date of birth.

(b) Prior to any sale of cannabis products through a drive through sales window the licensee shall verify that all persons in the vehicle are twenty-one (21) years old or older by means of an approved form of government-issued photographic identification containing a date of birth.

15.02.300 Retention of Sales Records

(a) At point of sale, the retailer shall retain, at a minimum the following information from consumers: (1) payment method; (2) amount of payment; (3) time of sale; (4) product quantity; and (5) other product descriptors. This data must be inputted into the Tribe's approved tracking system.

15.02.310 Comply with All Other Regulations

(a) Retail stores shall also comply with this chapter and all rules and regulations issued under this chapter that apply to cannabis businesses and facilities such as, but not limited to, security, surveillance, health and safety and audit and inspection requirements.

Subchapter 8 Consumption Lounge Operations

15.02.320 Consumption Lounge Sales Restrictions

(a) Cannabis Consumption Lounges may only offer for sale and sell cannabis, cannabis products and other products listed in this section or approved by the CCO.

(b) Consumption Lounges may not offer for sale or sell alcohol or tobacco.

15.02.330 Approved Products

(a) A cannabis Consumption Lounge will be permitted to sell:

(1) Pre-roll

(2) Concentrate

(3) Vaporizer cartridges

(4) Edible cannabis products (including food, tinctures, oils, and beverages)

(5) Other cannabis products approved by the Tribe

(6) Other products not containing cannabis as permitted by the CCO.

15.02.340 Prohibited Sales. a Consumption Lounge May Not:

(a) Sell cannabis and cannabis products to any person under the age of 21.

(b) Make sales that exceed the following single day transaction amounts to any particular purchaser:

Product	Single day transaction limit per purchaser
Cannabis	3 ounces
Cannabis concentrate, including vaporizer cartridges	24 grams

(c) Sell or offer for sale cannabis and cannabis products unless obtained from a processor, distributor or cultivator licensed by the CCO.

(d) Sell or offer for sale cannabis and cannabis products using: (1) a vending machine; (2) a drive-through sales window; or (3) an internet sales platform.

(e) Sell or offer for sale cannabis or cannabis products to a visibly intoxicated person.

(f) Sell or offer for sale cannabis or cannabis products that do not meet the tracking, packaging, labeling and testing requirements in this chapter; or

(g) Sell or offer for sale cannabis or cannabis products unless revenue stamps have been affixed to the product.

15.02.350 Verification of Age of Consumers

15.02.360 Retention of Sales Records

(a) At point of sale, the Consumption Lounge shall retain, at a minimum the following information from consumers:

(1) payment method;

(2) amount of payment;

(3) time of sale;

(4) product quantity; and

(5) other product descriptors.

This data must be inputted into the Tribe's approved tracking system.

15.02.370 Comply with All Other Regulations

(a) Consumption Lounges shall also comply with this chapter and all rules and regulations issued under this chapter that apply to cannabis businesses and facilities such as, but not limited to, security, surveillance, health and safety and audit and inspection requirements.

Subchapter 9 Cultivation Operations

15.02.380 General Requirements

(a) Permitted Activity. An adult-use cultivator license shall authorize the licensee to acquire, possess, cultivate and sell cannabis. It also allows the licensee to harvest, dry, cure, grade and trim cannabis and create pre-rolled marijuana cigarettes consisting solely of flower, trim, and unflavored paper wrapper, without additives. The cultivator may package and label flower, trim, and pre-rolls for retail sale and may transport cannabis to Processors and Retail Stores.

(b) No Retail Sales. A cultivator shall not sell or offer to sell cannabis, plants, immature plants or seedlings to consumers.

(c) No Extracting. A cultivation facility shall not engage in the processing of concentrates unless it has a license to do so.

(d) Plant Count Cap. The CCB may establish through regulations a cap on the total number of plants to be permitted, either on aggregate basis for all cultivation licensees or for each individual licensee.

(1) The CCB shall make this determination from time to time based on ensuring a supply of cannabis that is adequate to meet estimated consumer demand, but that does not result in excess supply.

(2) Cultivators shall be required to sell cannabis flower and trim, subject to the approved operating plan, to processors or retail stores as directed by the TCE at prices determined by the CCO.

15.02.390 Facility Requirements

(a) Security. Licensees must follow all CCO-mandated requirements regarding:

(1) Perimeter fencing of premises;

(2) Locks, cameras, alarms and other security and surveillance measures;

(3) Procedures limiting visitor access and general access by the public; and

(4) Any other security and surveillance measures required by the CCO.

(b) Code compliance. Licensees must follow all Tribal building codes including but not limited to:

(1) Building codes (requiring complete roof enclosure for indoor facilities)

(2) Electrical codes

(3) Plumbing, water and septic or sewer

(4) Ventilation and HVAC

(5) Environmental compliance

(6) Good agricultural practices

(1) Sites shall not be accessible to, or visible to the public; and

(2) Licensee must avoid adverse impacts or public nuisance.

Subchapter 10 Processing Operations

15.02.400 Permitted Activity

(a) A cannabis processor license authorizes the licensee to buy or acquire cannabis or cannabis extracts from a licensed cultivator or processor; and to possess, store and process cannabis and cannabis products. Processing shall include, but not necessarily be limited to, blending, extracting, infusing, packaging, labeling, branding or otherwise making or preparing cannabis products and transporting cannabis products to a Retail Store. Processing shall not include the cultivation of cannabis.

15.02.410 Limitation on Sales or Transfers

(a) A processor may process adult use cannabis products only for sale or distribution to licensed cannabis retail stores or other licensed processors.

15.02.420 No Retail Sale

(a) A licensed processor may not sell or offer to sell adult use cannabis products to consumers.

15.02.430 Purchase and Acquisition of Cannabis and Cannabis Extract

(a) A processor shall purchase all cannabis necessary for its processing from a licensed cultivation facility. A processor shall purchase all cannabis extract necessary for the creation of other cannabis products from a licensed Tier II processor.

15.02.440 Cannabis Extraction

(a) A Tier I processor shall not process cannabis concentrate by any method other than using water, lipids, mechanical separation, or sub-freezing temperature.

(b) A Tier II processor may process cannabis concentrate by extraction using water, lipids, mechanical separation, sub-freezing temperature, gases, solvents or other chemicals or chemical processes approved by the CCO.

(1) The CCO shall be obligated to establish rules specifically regulating the use by processors of inherently hazardous substances prior to issuing any licenses for processors utilizing inherently hazardous substances.

(2) Such regulation must ensure the safety of employees, invitees and others with respect to the use of inherently hazardous substances.

(3) The CCO shall require any applicant applying for a processor license to disclose whether or not it intends to utilize any inherently hazardous substance.

15.02.450 Processing of Edible Products

(a) Edible cannabis products to be sold or offered for sale to a consumer:

(1) May be processed in geometric shapes or in the shape of a cannabis leaf.

(2) Must be processed in a manner that results in the cannabinoid content within the product being homogeneous throughout the product or throughout each element of the product that has a cannabinoid content.

(3) Must be processed in a manner that results in the amount of cannabis concentrate within the product being homogeneous throughout the product or throughout each element of the product that contains cannabis concentrate.

(4) Must have a universal symbol stamped or embossed on each serving of the product, except that the CCO may determine by rule that, for a particular type of product, such stamping or embossing is impracticable and is not required.

(5) May not be processed in the distinct shape of a human, animal or fruit.

(6) May not contain more than 10 milligrams of THC per serving of the product and may not contain more than 100 milligrams of THC per package of the product.

(7) May not contain additives that are:

(A) Toxic or harmful to human beings;

(B) Specifically designed to make the product more addictive or that are misleading to consumers; or

(8) May not involve the addition of cannabis to a trademarked food or drink product, except when the trademarked product is used as a component of or ingredient in the edible cannabis product and the edible cannabis product is not advertised or described for sale as containing the trademarked product.

15.02.460 Participation in Tce

(a) Processors shall sell cannabis extract and other cannabis products to Processors and Retail Stores as directed by the TCE, at prices determined by the CCO, subject to the limits in the Processor's approved operating plan.

(b) The TCE shall not require a processor to produce cannabis extract or another cannabis product in a manner or of a form not routinely produced by the processor.

(c) Processors shall be required to produce products for other licensees if they are offered reasonable prices to be determined by the CCO.

Subchapter 11 Tracking

15.02.470 Obligations of Cultivation Licensees

(a) Cultivation Facility. A Cultivation licensee shall maintain a record-keeping system that is approved by the CCO and, at a minimum:

(1) Uses tracking ID numbers for all plants, inventory and transfers and sales; and

(2) Puts tracking ID on all product transferred or sold or in inventory.

(b) Information Required to be Inputted, Recorded. At a minimum the licensee shall record and input in the tracking system:

(1) Cannabis crop planted;

(2) Harvested cannabis crops;

(3) Records of all testing and sampling of crops;

(4) Records all sales or transfers of harvested cannabis (transferee, buyer, amounts in pounds) including tracking ID numbers;

15.02.480 Obligations of Processor Licensees

(a) Processing Facility. A processor licensee shall maintain a record-keeping system that is approved by the CCO and, at a minimum:

(1) Uses tracking ID numbers for all plants, inventory and transfers and sales; and

(2) Puts tracking ID on all product transferred or sold or in inventory.

(b) Information Required to be Inputted, Recorded. At a minimum, the licensee shall record and input in the tracking system:

(1) Cannabis received from any cultivator and cannabis extract received from any other processor;

(2) Cannabis the license processes in its facility (flower, concentrates and other cannabis products);

(3) Records of all licensee's sales or transfers of cannabis and cannabis products (transferee, buyer, amounts in pounds) including tracking ID numbers;

(1) Use tracking ID numbers for all products that are produced, transferred and sold;

(2) Put tracking ID on all product transferred or sold or in inventory.

15.02.490 Obligations of Retail Licensees

(a) A retail licensee shall maintain a record-keeping system that is approved by the CCO and, at a minimum:

(1) Records cannabis and cannabis products received from processor or cultivator;

(2) Records amount of product received and from whom;

(3) Records cannabis and cannabis products by category that are received by the processor;

(4) Records inventory of cannabis and products;

(5) Records all sales or transfers of cannabis products (amount sold, date of sale, price, fee imposed, age of buyer, name of product);

(b) Tracking ID numbers. All cannabis and products in inventory or sold must have tracking ID numbers.

Subchapter 12 Store/Facility Location

15.02.500 Location of Stores and Facilities

Due to the threat of exposure to children, young adults and the general public, any building housing a cannabis retail stores, processing, or cultivation facilities, unless otherwise permitted by the CCO, shall not be located within 500 feet of a sensitive site, as defined in this chapter.

15.02.510 Restrictions on Retail Store Buildings

At a minimum, retail stores shall observe the following building structure restrictions:

(a) Stores may be attached to an existing store building. However, the store must have ingress and egress to the outside separate from any other premises or use, including any foyer, hallways or other common area.

(b) Retail stores may only sell cannabis products described under the Ordinance or otherwise allowed by the CCO and may not house any other retail or commercial business or offer for sale or sell any products or services not approved by the CCO; and

Subchapter 13 Testing of Cannabis and Products

15.02.520 Testing of Cannabis and Products

(a) Every processor of cannabis shall contract with an independent laboratory, approved by the CCO, to test the cannabis and cannabis products it produces.

(b) The CCO may assign an approved testing laboratory which the processor must use.

(c) Processors shall make laboratory test reports available to licensed distributors and licensed retailers for all cannabis products they produce.

(d) License retail stores shall maintain accurate documentation of laboratory test reports for each product offered for sale. Such documentation shall be entered into the Tribe's monitoring system and made publicly available by the retailer.

(e) Onsite laboratory testing is permissible subject to regulation; however, such testing shall not be certified by the CCO and does not exempt the licensee from the requirements of quality assurance testing by an independent testing laboratory.

(f) The CCO shall have the authority to require any licensee to submit cannabis or cannabis products to one or more independent laboratories for testing. The CCO may issue regulations related to all aspects of third-party testing and quality assurance including, but not limited to:

(1) Minimum testing and sampling requirements;

(2) Testing and sampling methodologies;

(3) Testing reporting;

(4) Retesting; and

(5) Product quarantine, hold, recall and remediation.

(g) The CCO may waive any or all testing requirements until it determines that licensees may legally transfer cannabis or cannabis products to independent laboratories capable of performing such testing.

Subchapter 14 Labeling and Packaging

15.02.530 Labeling Requirements

(a) Cannabis and cannabis products to be sold, or offered for sale, must be labeled with the following information, as applicable to a product:

(1) License numbers of the cultivation facility, the processing facility and the retailer;

(2) Identity statement and universal symbol;

(3) Health and safety warning labels as required by rules adopted by the CCO;

(4) Batch number;

(5) A net weight statement;

(6) Information on the THC potency of the cannabis or cannabis product;

(7) Information on the amount of THC and cannabidiol per serving of the cannabis or cannabis product and, for edible cannabis products, the number of servings per package;

(8) Information on gases, solvents and chemicals used in cannabis extraction;

(9) Instructions on usage;

(10) For adult use cannabis products:

(A) the amount of cannabis concentrate per serving of the product, as measured in grams, and the amount of cannabis concentrate per package of the product, as measured in grams;

(B) a list of ingredients and possible allergens; and

(11) For edible cannabis products, a nutritional fact panel.

15.02.540 Packaging Requirements

Cannabis and cannabis products to be sold, or offered for sale must be packaged in the following manner, as applicable based on the cannabis or cannabis product to be sold:

(a) Must be prepackaged in child-resistant and tamper-evident packaging or must be placed in child-resistant and tamper-evident packaging at the final point of sale to a consumer.

(b) Must be prepackaged in opaque packaging or an opaque container or must be placed in opaque packaging or an opaque container at the final point of sale to a consumer.

(c) For multi-serving liquid adult use cannabis products must include an integral measurement component and a child-resistant cap; and

(d) Must conform to all other applicable requirements and restrictions imposed by rule by the CCO.

15.02.550 Other Allowable Labeling and Packaging

Cannabis and cannabis products to be sold to a consumer may include on the label or the packaging of the cannabis or cannabis product:

(a) A statement of compatibility with dietary practices.

(b) Depictions of geometric shapes or cannabis leaves.

(c) Use of the terms "organic", "organically cultivated" or "organically grown" in accordance with requirements adopted by rule by the CCO; and

(d) Any other information that has been preapproved by the CCO.

15.02.560 Labeling and Packaging Prohibitions

Cannabis and cannabis products to be sold to a consumer:

(a) May not be labeled or packaged in violation of a federal trademark law or regulation or in a manner that would cause a reasonable consumer confusion as to whether the cannabis or cannabis product was a trademarked product.

(b) May not be labeled or packaged in a manner that is specifically designed to appeal particularly to a person under 21 years of age.

(c) May not be labeled or packaged in a manner that obscures identifying information on the label or uses a false or deceptive label.

(d) May not be sold or offered for sale using a label or packaging that depicts a human, animal or fruit; and

(e) May not be labeled or packaged in violation of any other labeling or packaging requirement or restriction imposed by rule by the CCO.

Subchapter 15 Advertising and Marketing

15.02.570 General Requirement: No Deceptive, False or Misleading Statements

(a) A licensed AUC business shall not engage in advertising that is misleading, deceptive or false. A licensee shall not make any misleading, deceptive or false assertions or statements on any product, any sign, or any document provided to a consumer.

15.02.580 Advertising: All Media

(a) A licensed AUC business may advertise on television radio, a print publication or via the internet only where at least 71.6 percent of the audience is reasonably expected to be at least 21 years or older.

15.02.590 No Safety Claims

(a) A licensed AUC business may not engage in advertising that asserts its products are safe because they are regulated by the Tribe or because they are tested.

15.02.600 Outdoor Advertising

(a) A licensed AUC business shall not advertise on any outdoor sign that is within 500 feet of a sensitive area.

15.02.610 No Content That Targets Minors

(a) A licensed AUC business shall not include in any form of advertising or signage any content that specifically targets any individual under the age of 21, including but not limited to cartoon characters or similar images.

15.02.620 Advertising or Marketing Directed Toward Location-Based Devices

(a) A licensed AUC business may not engage in advertising via marketing directed towards location-based devices, including but not limited to cellular phones, unless the mobile device application installed on the device includes a permanent and easy opt-out feature.

15.02.630 Pop-up Advertising

(a) A licensed AUC business shall not utilize unsolicited pop-up advertising on the internet.

15.02.640 Event Sponsorship

(a) A licensed AUC business may sponsor a charitable, sports, or similar event, but the business shall not engage in advertising at, or in connection with, such an event unless the business has reliable evidence that at least 71.6 percent of the audience at the event and/or viewing the event is reasonably expected to be at least 21 years or older.

Subchapter 16 Health and Safety Rules

15.02.650 Health and Safety Rules

The CCO shall adopt labeling, packaging and other necessary health and safety rules for cannabis and cannabis products to be sold or offered for sale by a licensee to a consumer. Rules adopted pursuant to this subsection must establish mandatory health and safety standards applicable to the cultivation of cannabis, the manufacture of cannabis products and the packaging and labeling of cannabis and cannabis products sold by a licensee to a consumer. Such rules must address, but are not limited to:

(a) Requirements for the storage, warehousing and transportation of cannabis and cannabis products by licensees;

(b) Sanitary standards for cannabis establishments, including, but not limited to, sanitary standards for the manufacture of cannabis and cannabis products; and

Subchapter 17 Security and Surveillance Rules

15.02.660 Security and Surveillance

(a) All licensed facilities shall have a security system to prevent and detect diversion, theft or loss of cannabis and cannabis products utilizing commercial grade equipment which shall, at a minimum, include alarms, motion detectors and video cameras.

(b) All businesses shall ensure that all security system equipment and recordings in a secure location so as to prevent theft, loss, destruction or alterations.

15.02.670 Additional Security

(a) In addition to the requirements listed above in this section, each store and facility shall have a back-up alarm system approved by the CCO that shall detect unauthorized entry during times when no employees are present at the store or facility and that shall be provided by a company supplying commercial grade equipment.

(b) A business shall limit access to any surveillance areas solely to persons that are essential to surveillance operations, law enforcement agencies, security system service employees, the CCO or the CCO's authorized representative, and others when approved by the CCO.

(c) A business shall make available to the CCO upon request a current list of authorized employees and service employees who have access to any surveillance room. A business shall keep all on-site surveillance rooms locked and shall not use such rooms for any other function.

(d) A business shall keep illuminated the outside perimeter of any facility that is operated under the business' license.

(e) A business shall keep all security equipment in full operating order and shall test such equipment no less than semi-annually at each store or facility. Records of security tests must be maintained for five years and made available to the CCO upon request.

(f) Stores and facilities must be securely locked and protected from unauthorized entry at all times. The licensee shall be responsible for ensuring the integrity of the security of the stores and facility and the maintenance of sanitary operations when permitting access to the facility.

(g) The licensee shall maintain a visitor log of all persons other than employees or emergency personnel responding to an emergency that access any secured areas, which shall include the name of the visitor, date, time and purpose of the visit. The visitor log shall be available to the CCO at all times during operating hours and upon request.

Subchapter 18 Violations; Penalties

15.02.680 General

The CCO may impose penalties on licensee for license violations and penalties upon non-compliant cannabis businesses (i.e., those operating without obtaining a Tribal AUC business license). Any penalties, orders or decisions of either the CCB or CCO are enforceable by the Tribal Court, which has jurisdiction over any and all matters arising under this chapter. The penalties authorized in Sec. 18.02 - 18.07 are in addition to any criminal or civil penalties that may be imposed pursuant to other applicable laws or rules.

15.02.690 Monetary Penalties

(a) The CCO shall adopt rules setting forth potential amounts of monetary penalties to be imposed based upon specific categories of unauthorized conduct including major and minor license violations.

(b) All monetary penalties imposed must be paid by the licensee to the CCO in the form of cash or in the form of a certified check or a cashier's check.

15.02.700 License Suspension

A licensee whose license has been suspended may not, for the duration of the period of suspension, engage in any activities relating to the operation of the cannabis business.

15.02.710 License Revocation

A licensee whose license has been revoked shall cease immediately all activities relating to the operation of the cannabis business the licensee was previously licensed to operate and shall ensure that all adult use cannabis and adult use cannabis products in the possession of the licensee are forfeited to the CCO for destruction.

15.02.720 Cease and Desist Orders

The CCO may issue cease and desist orders upon any persons who operate any AUC businesses without a Tribal license or upon licensees who operate in violation of this chapter. Such orders may include a requirement that the person hold cannabis plants, cannabis, or cannabis products in a secure location pending further instruction from the CCO.

15.02.730 Imposition of Monetary Penalty upon Suspension or Revocation

In addition to suspending or revoking a licensee's license, the CCO may impose a monetary penalty on the licensee.

15.02.740 Order for Destruction of Cannabis or Cannabis Products

If the CCO issues a final order imposing a monetary penalty on or a license suspension, revocation of a licensee or operation without a license, the CCO may specify in the order, in addition to any other penalties imposed in the order, that all or a portion of the cannabis or cannabis products in the possession of the licensee or party are not authorized and are subject to destruction. A person subject to a final order directing the destruction of cannabis or cannabis products shall forfeit the cannabis and cannabis products described in the order.

15.02.750 Investigation

If the CCO is notified by a law enforcement agency that there is a pending investigation of a person subject to an order, the CCO may not destroy any cannabis or cannabis products of that person until the destruction is approved by the law enforcement agency.

15.02.760 Voluntary Surrender

The CCO may negotiate the voluntary surrender of a license in combination with or in place of any other penalties under this subchapter. The agreement may stipulate a time during which the licensee may not apply for a new license.

Subchapter 19 Growing Plants for Personal Use

15.02.770 Personal Cannabis Plants

Adult tribal members may grow and possess up to six (6) mature cannabis plants and six (6) immature plants within his/her private residence for personal use.

15.02.780 Eligibility

Tribal members must be 21 years old or older.

15.02.790 Requirements for Personal Plant Grow

(a) Persons who grow and possess plants must, at a minimum, comply with the following requirements:

(1) Cannabis may not be grown (cultivated) openly or publicly.

(2) In no event can more than 12 plants of any size be grown or kept within, or on the same legal parcel as, any single-family dwelling.

(3) Cannabis cannot be grown in a two-family (duplex), multi-family (apartment building) or single-family attached dwelling (ex. townhouse sharing a common wall with another unit).

(4) All cannabis must be grown and kept in a locked and enclosed space.

(5) Cannabis cannot be sold.

Subchapter 20 Miscellaneous

15.02.800 Sovereign Immunity

Nothing in this chapter shall be interpreted as waiving or diminishing the sovereign immunity of the Saint Regis Mohawk Tribe or its subordinate entities, agencies, officers, agents, employees, instrumentalities, or authorize in any form a prospective waiver of such sovereign immunity.

15.02.810 Regulations

The CCO and CCB may issue regulations as appropriate for the proper administration of this chapter and will be processed following the Tribal Procedures Act and include notice to, and review by, the Community.

15.02.820 Effective Date

This chapter shall be effective upon approval by the Tribal Council.

15.02.830 Amendments

This chapter may be amended by the Tribal Council and shall be processed following the Tribal Procedure Act and include notice to, and review by, the Community. Any changes to fees, fee structure, monetary penalties may be made by the CCO in consultation with and with the approval of the CCB and Tribal Council without notice to, and review by, the Community.

15.02.840 Severability

The Provisions of this chapter Shall Be Severable and If Any Part or Provision Shall Be Held Void by Any Court of Competent Jurisdiction, the Decision of the Court so Holding Shall Not Affect or Impair Any of the Remaining Parts or Provisions of this chapter

Chapter 15.03 Medical Marijuana Ordinance

Subchapter 1 General

15.03.010 Title

This chapter shall be known as the "Saint Regis Mohawk Tribe Medical Marijuana Ordinance".

15.03.020 Authority

(a) The Saint Regis Mohawk Tribal Council ("Tribal Council") is the duly recognized governing body of the Saint Regis Mohawk Tribe ("Tribe") and is responsible for the health, safety, education and welfare of all members of the Tribe.

(b) The Tribe has the inherent authority to regulate business activities within its Territory subject to the requirements of applicable Tribal law. This authority includes the licensing of businesses on Tribal Territory and establishing regulatory regimes that apply to such businesses.

15.03.030 Purpose

(a) The purpose of this Saint Regis Mohawk Tribe Medical Marijuana Ordinance ("Ordinance") is to legalize the possession, acquisition, use, delivery, transfer, transportation, manufacture and sale of medical marijuana on Tribal Territory subject to strict rules and regulations that are set forth herein.

(b) This chapter establishes a comprehensive Tribal regulatory process over all aspects of medical marijuana use including, but not limited to, possession, acquisition, use, delivery, transfer, transportation, manufacture, and sale of medical marijuana on Tribal Territory. To administer this process, the Tribe herein establishes two regulatory bodies: (1) the Akwesasne Public Health Authority that will serve as the administrator of the rules and regulations; and (2) the Akwesasne Medical Marijuana Advisory Board that will act as an advisory body on scientific and technical matters.

15.03.040 Definitions

(a) The following are definitions of terms and words used in this chapter.

(1) "Tribal Territory" or "Territory" means all lands within the 1796 Treaty with the Seven Nations of Canada (97 Stat. 55) and includes any other lands over which the Tribe exercises jurisdiction.

(2) "Saint Regis Mohawk Tribe" or "Tribe" means the federally recognized Saint Regis Mohawk Tribe with government offices in Akwesasne, New York.

(3) "Tribal Council", for purposes of this chapter, means the three duly elected Chiefs of the Saint Regis Mohawk Tribe.

(4) "Tribal Member" or "Member" means a person who is enrolled under the Tribe's Membership Code or a person who is eligible to be enrolled regardless of where they reside. "Membership Code" means the 1986 Membership Code of the Tribe, as amended.

(5) "Tribal Election and Referendum Ordinance" means the Tribal Election and Referendum Ordinance, as amended.

(6) "Medical Marijuana" means all parts of the plant of the genus Cannabis, whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, intended for a certified medical use. Any form of medical marijuana not approved by the Authority pursuant to this chapter is expressly prohibited. It does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination.

(7) "Practitioner" means (a) a licensed physician' (b) a licensed nurse practitioner that is supervised by a licensed physician; (c) or a licensed physician assistant that is supervised by a licensed physician.

(8) "Registered entity" means a means a for-profit business or not-for-profit business that is majority owned by a member of the Tribe. "Majority owned" means ownership of over 50% shares or interest in a business.

(9) "Approved medical marijuana product" means the final manufactured product delivered to the patient that represents a specific brand with a defined cannabinoid content and active and inactive ingredients, prepared in a specific dosage and form, to be administered as recommended by the registered practitioner.

(10) "Good moral character" refers to a personal history of honesty, fairness, and respect for the rights of others.

(11) "Tribal Procedures Act" refers to the Tribal Procedures Act of 2013, as amended.

Subchapter 2 Tribal Regulatory Agencies

15.03.050 Akwesasne Public Health Authority

(a) The Tribal Council establishes the Akwesasne Public Health Authority ("Authority") as the regulatory body to administer the provisions of this chapter.

(b) The powers and duties of the Authority shall include, but not be limited to:

(1) Administer the provisions of this chapter including making and enforcing all decisions of the Authority;

(2) Accept, review, approve, or disapprove applications required under this chapter including, but not limited to, applications for registration of certified patients, practitioners, registered entities;

(3) Impose and collect any fees or fines necessary to the regulation of the Ordinance;

(4) Adopt regulations and rules after consultation with the Advisory Board;

(5) Issue orders required under the Ordinance including, but not limited to, orders to: cease and desist, closures of facilities, suspension and revocation of licenses as necessary to protect public safety;

(6) Monitor and regulate all activities of registered entities;

(7) Inspect and examine all facilities, buildings, real property used in manufacturing and dispensing of medical marijuana products; and

(8) Keep accurate records of all matters within the duties of the Authority.

(c) The Authority shall have three (3) Members with one member serving as Chairperson. Each member shall be appointed by the Tribal Council, and shall serve staggered four-year terms Tribe.

(d) Qualifications for Members of the Authority shall be as follows:

(1) Must be a member of the Saint Regis Mohawk Tribe;

(2) Must be at least twenty-five (25) years old (on date of appointment);

(3) Must possess good moral character and not have been convicted of a serious crime as defined in the Tribe's Election and Referendum Ordinance, as amended;

(4) Must pass a background check administered by the Tribe and/or Tribal Police;

(5) Must be willing and capable of maintaining communications through technology (email, texts, mobile phone) so as to be accessible to the Authority;

(6) At least one member of the Authority shall have experience and expertise in public health, public Safety, and/or health care.

(e) The Authority may receive staff assistance from tribal agencies and departments including the Tribal Compliance Department.

(f) Subject to Tribal Council approval, the Authority may also negotiate cooperative agreements with state and federal governments on matters that are in the best interest of the Tribe and its members to ensure a lawful and well-regulated marijuana market. Such agreements will be submitted to the tribal membership under the Tribal Procedures Act for public comment before finally approved by the Tribal Council.

(g) Any person or entity aggrieved by a final, appealable decision of the Authority may seek review in the Saint Regis Mohawk Tribal Court under the Saint Regis Mohawk Tribal Civil Code.

15.03.060 Akwesasne Medical Marijuana Advisory Board

(a) The Tribal Council establishes the Akwesasne Medical Marijuana Advisory Board ("Advisory Board") to serve as a technical, scientific advisory board to provide expert advice to the Authority on all aspects of medical marijuana. The Advisory Board's function, in that regard, is advisory and not regulatory.

(b) The Advisory Board's duties and powers shall include, but not be limited to:

(1) Serve as a scientific "expert" body that will provide expert advice on all aspects of medical marijuana to the Authority;

(2) Provide advisory opinions and advice to the Authority on any technical or scientific issue or matter that may arise regarding the Ordinance and its interpretation; and

(3) Submit recommendations to the Tribal Council and Authority regarding the need to amend the Ordinance based upon changed circumstances, changes in the law and any scientific trends.

(c) The Advisory Board shall have five (5) members with one member serving as Chairperson. Each member shall be appointed by the Tribal Council, and shall serve staggered four-year terms.

(d) Members of the Advisory Board shall have the following qualifications:

(1) They must be at least twenty-five (25) years old (on date of appointment);

(2) They must possess good moral character and not have been convicted of a serious crime as defined in the Tribe's Election and Referendum Ordinance, as amended;

(3) They must be willing to take, and must pass, a background check administered by the Tribe and/or Tribal Police;

(4) They must be willing and capable of maintaining communications through technology (email, texts, mobile phone) so as to be accessible to the Advisory Board;

(5) Three (3) Advisory Board members will be outside experts who must have knowledge and experience with medical marijuana and expertise in any one of the following areas:

(A) medicine and/or pharmacology;

(B) laboratory testing;

(D) agriculture and/or pesticide application.

(6) Two (2) Advisory Board members will be Tribal members who must have experience and expertise in any one of the following areas:

(A) public health;

(B) public safety;

(e) Decisions of the Advisory Board are advisory in nature and will not be subject to judicial review.

15.03.070 Other Board Requirements

(a) No member of the Authority or Advisory Board shall actively participate in, or be employed by, a Registered Entity or any other entity or business that is subject to regulation under this chapter.

(b) Authority and Advisory Board members will be entitled to compensation according to the standard schedule of fees and compensation provided for tribal boards, committees and commissions.

(c) The Authority and the Advisory Board will adopt their own Bylaws and will nominate a Chairperson by motion and majority vote for a one (1) year term or until a successor is elected. The Chairperson will preside over all meetings and perform all duties of that office as required under approved By-Laws. The Authority and Advisory Board will also nominate and elect other Officers (Vice-Chair, Treasurer, Secretary) with duties and requirements to be set forth in approved By-Laws. The Authority and the Advisory Board will schedule and hold regular meetings.

(d) Members of the Authority and Advisory Board may be removed by Tribal Council, either by the Council itself or upon recommendation by a board. Members may be removed based upon violation of any provision of this chapter, failure to perform duties as a Member, excessive absences from meetings, failure to recuse oneself due to a conflict of interest or conduct unbecoming a Member.

(e) Member vacancies will be filled by the Tribal Council under the same procedure used for appointment. Members appointed to fill vacancies will serve the remainder of the vacant seat. (f) The Authority and Advisory Board will provide regular reports to the Tribal Council summarizing, among other things, their official actions, activities, investigative reports, and reports received from registered entities to keep the Tribal Council fully informed as to the status of their activities.

Subchapter 3 Practitioner Registration

15.03.080 Practitioner Registration

(a) A "Practitioner" means (a) a licensed physician; (b) a licensed nurse practitioner who is supervised by a licensed physician; or (c) a licensed physician assistant who is supervised by a licensed physician.

(b) In order to be registered by the Authority a practitioner must meet the following qualification:

(1) Be licensed and in good standing with an applicable regulatory body;

(2) Be qualified to treat patients with a qualifying serious condition as defined in Section 4.1, below;

(3) Have successfully completed a two to four-hour course approved by the Authority;

(4) Have applied to the Authority for a registration or a renewal of registration to issue patient certifications in a manner and format determined by the Authority; and

(5) Have been granted such registration by the Authority.

(c) The Authority will approve at least one, if not more, courses for practitioners seeking to become registered, which shall be two to four hours in duration. The educational content of such course shall include: the pharmacology of marijuana; contraindications; side effects; adverse reactions; overdose prevention; drug interactions; dosing; routes of administration; risks and benefits; warnings and precautions; abuse and dependence; and such other components as determined by the Authority.

Subchapter 4 Practitioner Certification of Patients

15.03.090 Issuing Certifications (Prescriptions) to Patients

(a) A practitioner who is registered under Subchapter 3, above, may issue certifications (prescriptions) to certified patients for the use of an approved medical marijuana products. Such certification shall contain:

(1) The practitioner's name, business address, telephone number and email address;

(2) The practitioner's registration number as issued by the Authority;

(3) The practitioner's Drug Enforcement Administration registration number;

(4) A statement that the practitioner is licensed and in good standing;

(5) A statement that the practitioner is registered with the Authority to issue the certification;

(6) A statement that the practitioner is caring for the patient in relation to the patient's qualifying serious condition;

(7) The patient's name, date of birth, address, telephone number and email address if available;

(8) The patient's diagnosis, limited solely to the specific severe debilitating or life- threatening condition(s) listed below;

(A) cancer;

(B) positive status for human immunodeficiency virus or acquired immune deficiency syndrome;

(D) Parkinson's disease;

(E) multiple sclerosis;

(F) damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity;

(G) epilepsy;

(H) inflammatory bowel disease;

(I) neuropathies;

(J) Huntington's disease;

(K) any severe debilitating pain that the practitioner determines degrades health and functional capability; where the patient has contraindications, has experienced intolerable side effects, or has experienced failure of one or more previously tried therapeutic options; and where there is documented medical evidence of such pain having lasted three months or more beyond onset, or the practitioner reasonably anticipates such pain to last three months or more beyond onset;

(L) post-traumatic stress disorder;

(M) pain that degrades health and functional capability where the use of medical marijuana is an alternative to opioid use, provided that the precise underlying condition is expressly stated on the patient's certification; or

(N) substance use disorder; or

(O) any other condition added by the Authority (based upon Advisory Board recommendation and Tribal Council approval).

(9) The condition or symptom that is clinically associated with, or is a complication of the severe debilitating or life-threatening condition listed in Paragraph 8, above, of this Subsection. Clinically associated conditions, symptoms or complications are limited solely to:

(A) Cachexia or wasting syndrome;

(B) severe or chronic pain resulting in substantial limitation of function;

(D) seizures;

(E) severe or persistent muscle spasms;

(F) post-traumatic stress disorder;

(G) opioid use disorder; or

(H) such other conditions, symptoms or complications as added by the Authority.

(10) A statement that by training or experience, the practitioner is qualified to treat the serious condition, which encompasses the severe debilitating or life-threatening condition listed pursuant to paragraph 8 of this subdivision and the clinically associated condition, symptom or complication listed pursuant to Paragraph 9 of this Subsection;

(11) A statement that in the practitioner's professional opinion and review of past treatments, the patient is likely to receive therapeutic or palliative benefit from the primary or adjunctive treatment with medical marijuana for the serious condition;

(12) Any recommendations or limitations the practitioner makes to the certified patient and/or the patient's designated caregiver concerning:

(A) the authorized brand, authorized form, administration method, dosage and any limitations in the use of the approved medical marijuana product; and

(B) the total amount of usable approved medical marijuana product that may be dispensed to the patient, in measurable controlled doses, which shall not exceed a thirty (30) day supply, if used as directed.

(13) A statement that the practitioner has explained the potential risks and benefits of the use of medical marijuana to the qualifying patient and has documented in the patient's medical record that such explanation has been provided to the patient.

(14) To the extent that a practitioner is seeking to authorize the use of an approved medical marijuana product by a patient who is under the age of eighteen or a person who is otherwise incapable of consenting to medical treatment, the practitioner shall explain the potential risks and benefits of medical marijuana to the patient's parent or legal guardian, and if appropriate, to the minor patient. The practitioner shall document in the patient's medical record that such explanation has been provided as required herein.

(15) A statement that the patient, or the patient's parent or legal guardian if applicable, has provided informed consent.

(b) The certification shall state the date upon which the certification shall expire, which shall be no longer than one year after the date it was issued, unless the patient is terminally ill. If the practitioner issues a certification to a patient who is terminally ill, the certification shall not expire until the patient's death or the practitioner revokes the certification.

(c) Practitioners shall utilize a form developed by the Authority for the certification required in this section. The practitioner shall date and place his or her handwritten signature upon the printed certification, and provide the printed certification to the patient. The practitioner shall also maintain a copy of the signed certification in the patient's medical record.

(d) Prior to issuing, modifying or renewing a certification, the practitioner shall consult available data for the purpose of reviewing a patient's controlled substance history.

(e) The Authority may add additional qualifying conditions upon the recommendation of the Advisory Board with the approval of the Tribal Council.

Subchapter 5 Application for Registration of Certified Patients and Caregivers

15.03.100 Patient Eligibility for Registration Cards

(a) The following persons are eligible to be "certified patients" under this chapter to obtain Registration Identification Cards:

(1) Persons who are enrolled or eligible for enrollment in the Tribe as determined by the Tribe's Enrollment Code and as certified by the Tribal Clerk;

(2) Any person who is resident of New York State who is certified under this chapter;

(3) Any person who possesses a certification issued by a registered practitioner;

(4) Any person who is certified by the Authority under this chapter.

(b) The Authority is authorized to add eligible persons to the above list after consultation with the Advisory Board and approval of the Tribal Council following the amendment procedures under this chapter.

(c) Certified patients are entitled to obtain a Registration Identification Card. To obtain, amend or renew a registry identification card, a certified patient shall file a registry application with the Authority, on a form or in a manner determined by the Authority, which shall include the documentation required in Subsection (a) above.

15.03.110 Minors

(a) If the applicant for a registry identification card is under the age of eighteen or a person who is otherwise incapable of consenting to medical treatment, the application shall be made by an appropriate person over twenty-one years of age. In preparing the application, the applicant may designate up to two proposed designated caregivers who shall be either: (i) a parent or legal guardian of the certified patient; (ii) a person designated by a parent or legal guardian, or (iii) an appropriate person approved by the Authority upon a sufficient showing that no parent or legal guardian is appropriate or available.

(b) As a condition of registration of a certified patient who is a minor or is incapable of medical decision-making, the applicant shall consent, in a manner determined by the Authority, to the certified patient's use of an approved medical marijuana product, and shall acknowledge that the parent, legal guardian or other appropriate person, as applicable, will control the acquisition and possession of the medical marijuana and any device used for its administration.

(c) Once the certified patient who is a minor or is incapable of medical decision-making is registered, the proposed designated caregiver(s) may apply for and, if approved, receive a designated caregiver registration.

15.03.120 Review of Application

(a) Prior to issuing or renewing a registry identification card, the Authority may verify the information submitted by the applicant. The applicant shall provide, at the Authority's request, such information and documentation, including any consents or authorizations to contact treating practitioners that may be necessary for the Authority to verify the information.

(b) The Authority shall approve, deny, or determine incomplete or inaccurate an application to issue or renew a registry identification card within thirty (30) days of receipt of the application. If the application is approved within the 30-day period, the Authority shall issue a registry identification card as soon as is reasonably practicable.

(c) The Authority shall notify the applicant in writing, by email, by telephone, or in another manner as determined appropriate by the Authority, if an application is incomplete or factually inaccurate, and shall explain what documents or information is necessary for the Authority to consider the application complete and accurate.

(d) An applicant shall have thirty (30) days from the date of a notification of an incomplete or factually inaccurate application to submit the materials required to complete, revise, or substantiate information in the application. If the applicant fails to submit the required materials within such thirty-day time period, the application shall be denied by the Authority.

(e) Applicants whose applications are denied may submit a new application for an initial or renewal of a registry identification card, together with the applicable fee as set forth herein.

(f) A certified patient may designate up to two designated caregivers either on the application for issuance or renewal of a registry identification card or in another manner determined by the Authority.

(g) The application for issuance or renewal of a registry identification card shall include the following information:

(1) The name of the proposed designated caregiver(s);

(2) The address of the proposed designated caregiver(s);

(3) The date of birth of the proposed designated caregiver(s), unless the proposed designated caregiver is not a natural person;

(4) Any other individual identifying information concerning the proposed designated caregiver(s) required by the Authority.

15.03.130 Designated Caregiver Registration

(a) A certified patient's designation of a designated caregiver shall not be valid unless and until the proposed designated caregiver successfully applies for and receives a designated caregiver registry identification card.

(b) A person selected by a certified patient as a designated caregiver may apply to the Authority for a registry identification card or renewal of such card on a form or in a manner determined by the Authority. The proposed designated caregiver shall submit an application to the Authority which shall contain the following information and documentation:

(1) For a proposed designated caregiver the individual shall submit:

(A) the applicant's full name, address, date of birth, telephone number, email address if available, and signature;

(B) if the applicant has a registry identification card, the registry identification number;

(D) a statement that the applicant agrees to secure and ensure proper handling of all approved medical marijuana products.

(c) Prior to issuing or renewing a registry identification card, the Authority may verify the information submitted by the applicant. The applicant shall provide, at the Authority's request, such information and documentation, including any consents or authorizations that may be necessary for the Authority to verify the information.

(d) The Authority shall approve, deny or determine incomplete or inaccurate an initial or renewal application within thirty (30) days of receipt of the application. If the application is approved within the 30-day period, the Authority shall issue a registry identification card as soon as is reasonably practicable.

(e) The Authority shall notify the applicant in writing, by email, by telephone, or in another manner as determined appropriate by the Authority if an application is incomplete or factually inaccurate, and shall explain what documents or information is necessary for the Authority to consider the application complete and accurate.

(f) An applicant shall have thirty (30) days from the date of a notification of an incomplete or factually inaccurate application to submit the materials required to complete, revise or substantiate information in the application. If the applicant fails to submit the required materials within such thirty-day time period, the application shall be denied by the Authority.

(g) Applicants whose applications are denied may submit a new initial or renewal application for a registry identification card, together with the applicable fee as set forth herein.

(h) The Authority shall deny a registry identification card for an applicant who:

(1) is already a designated caregiver for five currently certified patients or has an application pending that, if approved, would cause the proposed designated caregiver to be a designated caregiver for more than five currently certified patients; or

(2) in accordance this section, fails to provide complete or factually accurate information in support of his or her initial or renewal application.

Subchapter 6 Registered Entities

15.03.140 Application for Initial Registration as a Registered Entity

(a) Businesses eligible to obtain registration as registered entities must be owned and controlled by Tribal Members. "Ownership" is defined as having at least 51% tribal member ownership. "Controlled" means that all material decisions of the business must be made by the Tribal Member owners.

(b) In order to operate as a registered entity, an entity must file an application on forms or in a manner prescribed by the Authority. The application shall set forth or be accompanied by the following:

(1) The name, address, phone and email address of the applicant;

(2) Identification of all real property, buildings and facilities that will be used in manufacturing, as defined in Subchapter 5, and dispensing of the medical marijuana products;

(3) Identification of all equipment that will be used to carry out the manufacturing, processing, transportation, distributing, sale and dispensing activities described in the application and operating plan;

(4) An operating plan that includes a detailed description of the applicant's manufacturing processes, transporting, distributing, sale and dispensing policies or procedures. The operating plan shall also include:

(A) detailed description of any devices used with approved medical marijuana products to be offered or sold by the registered entity;

(B) policies and procedures related to security and control measures that will be in place to prevent diversion, abuse, and other illegal or unauthorized conduct relating to medical marijuana and are consistent with provisions set forth in this part;

(C) a standard operating procedure manual for all methods used from cultivation of the medical marijuana through packaging, sealing and labeling of each lot of medical marijuana product. The procedures shall include use of good agricultural practices (GAPs). Standard operating procedures shall be able to be validated to demonstrate that the applicant will be able to produce and dispense consistent and reproducible medical marijuana product such that, for each form of each brand produced, there is homogeneity, absence of contamination and reproducibility of the brand profile in each lot as defined in this chapter;

(D) quality assurance plans, including but not limited to plans to detect, identify and prevent dispensing errors;

(E) policies and procedures to document and investigate approved medical marijuana product returns, complaints and adverse events, and to provide for rapid voluntary or involuntary recalls of any lot of medical marijuana product. Such policies and procedures shall include a plan for any retesting of returned approved medical marijuana products, storage and disposal of marijuana and any manufactured medical marijuana products not passing requirements, and a requirement that adverse events and total recalls are reported to the Authority within twenty-four hours of their occurrence;

(F) a quality assurance program to track contamination incidents and document the investigated source of such incidents, and the appropriate corrective action(s) taken;

(G) detailed description of plans, procedures and systems adopted and maintained for tracking, record keeping, record retention and surveillance systems, relating to all medical marijuana at every stage including cultivating, possessing of marijuana, and manufacturing, delivery, transporting, distributing, sale and dispensing by the proposed registered entity;

(H) proposed hours of operation for the manufacturing and dispensing facilities.

(5) Copies of the organizational and operational documents of the applicant, including but not limited to, as applicable: the certificate of incorporation, bylaws, articles of the entity, partnership agreement, operating agreement and other applicable documents and agreements, and all amendments thereto;

(6) The name, residence address and title of each of the board members, officers, managers, owners, partners, principal stakeholders, directors and any person or entity that is a member of the applicant.

(7) A statement that the applicant is able to comply with all applicable tribal laws and regulations relating to the activities in which it intends to engage under the registration;

(8) Copies of all applicable executed and proposed deeds, leases, and rental agreements or executed option contracts related to the entity's real property interests, that shows that the applicant possesses or has the right to use sufficient land, buildings, and other premises as specified in the application and equipment to properly carry on the activities for which registration is sought. a financial statement setting forth all elements and details of any business transactions connected with the application, including but not limited to all agreements and contracts for consultation and/or arranging for the assistance in preparing the application;

(9) Architectural program and sketches of the applicant's proposed manufacturing and dispensing facility(ies) including the following:

(A) site plans;

(B) schematic architectural and engineering design drawings and single line sketches in an appropriate scale showing the relationship of various buildings to each other, room configurations, major exit corridors, exit stair locations, and circulation along with existing buildings if additions or alterations are part of the project;

(C) outline specifications for the type of construction proposed including a description of energy sources, type and location of engineering systems proposed for heating, cooling, ventilation and electrical distribution, water supply and sewage;

(D) a security plan indicating how the applicant will comply with the security requirement in this chapter and any other applicable law, rule, or regulation; and

(E) the registered entity shall submit detailed floor plans indicating the activities performed in each area and security plans (physical and cyber) consistent with the requirements of Subchapter 7 [Manufacturing];

(10) A construction timetable;

(11) A statement as to whether the applicant, any controlling person of the applicant, any manager, any sole proprietor applicant, any general partner of a partnership applicant, any officer and member of the board of directors of a corporate applicant, and corporate general partner had a prior discharge in bankruptcy or was found insolvent in any court action;

(12) If any controlling person of the applicant, any manager, any sole proprietor applicant, any general partner of a partnership applicant, any officer and member of the Advisory Board of directors of a corporate applicant, or corporate general partner or a combination of such persons collectively, maintains a ten percent interest or greater in any firm, association, foundation, trust, partnership, corporation, or other entity or if such entity maintains a ten percent interest or greater in the applicant, and such entity will or may provide goods, leases, or services to the registered entity, the value of which is or would be five hundred dollars or more within any one year, the name and address of the entity shall be disclosed together with a description of the goods, leases or services and the probable or anticipated cost to the registered entity;

(13) If the applicant is a corporate subsidiary or affiliate of another corporation, disclosure of the parent or affiliate corporation including the name and address of the parent or affiliate, the primary activities of the parent or affiliate, the interest in the applicant held by the parent or affiliate and the extent to which the parent will be responsible for the financial and contractual obligations of the subsidiary;

(14) The most recent certified financial statement of the applicant, audited by an independent certified public accountant and prepared in accordance with generally accepted accounting principles (GAAP) applied on a consistent basis, including a balance sheet as of the end of the applicant's last fiscal year and income statements for the past two fiscal years, or such shorter period of time as the applicant has been in operation;

(15) If construction, lease, rental or purchase of the manufacturing or dispensing facility has not been completed, a statement indicating the anticipated source and application of the funds to be used in such purchase, lease, rental or construction;

(16) A staffing plan for staff involved in activities related to the cultivation of marijuana, the manufacturing and/or dispensing of approved medical marijuana products and/or staff with oversight responsibilities for such activities, which shall include:

(A) a senior staff member with a minimum of one (1) year experience in good agricultural practices (GAP);

(B) a quality assurance officer who shall exercise oversight of the entity's practices and procedures and who has documented training and experience in quality assurance and quality control procedures;

(D) a requirement that all staff involved in the manufacturing be trained in and conform to general sanitary practices; and

(E) policies and procedures to ensure that the proposed registered entity shall not employ anyone who would come in contact with or handle medical marijuana who has been convicted of any felony of sale or possession of drugs, narcotics, or controlled substances;

(17) Any other information as may be required by the Authority.

(c) An application under this section may be amended while the matter is pending before the Authority, if approved by the Authority upon good cause shown.

(d) The applicant shall verify the truth and accuracy of the information contained in the application. The Authority, in its discretion, may reject an application if it determines that information contained therein is not true and accurate.

15.03.150 Consideration of Registered Entities Applications

(a) Applicants for approval to operate as registered entities shall submit an application to the Authority, containing the information required in Section 15.03.140, below, in a manner and format determined by the Authority.

(b) Applications shall be accompanied by a non-refundable application fee in the amount of $1,000.

(1) The applicant will be able to manufacture approved medical marijuana products, each with a consistent cannabinoid profile (the concentration of total tetrahydrocannabinol (THC) and total cannabidiol (CBD) will define the brand) and each able to pass the required quality control testing;

(2) The applicant will produce sufficient quantities of approved medical marijuana products as necessary to meet the needs of certified patients;

(3) The applicant will be able to maintain effective control against diversion of marijuana and medical marijuana products;

(4) The applicant will be able to comply with all applicable state and local laws and regulations;

(5) The applicant is ready, willing and able to properly carry on the activities set forth in this part;

(6) The applicant possesses or has the right to use sufficient real property, buildings and equipment to properly carry on the activity described in its operating plan;

(7) It is in the public interest that such registration be granted;

(8) The number of registered entities in an area will be adequate or excessive to reasonably serve the area, including whether there is sufficient geographic distribution across the state;

(9) The moral character and competence of board members, officers, managers, owners, partners, principal stakeholders, directors, and members of the applicant's entity; and

(10) Evaluation of the applicant's proposed operating plan and suitability of the proposed manufacturing and dispensing facilities, including but not limited to the suitability of the location and architectural and engineering design of the proposed facilities. Authority approval of the applicant's operating plan and architectural and engineering design of the proposed facilities shall be required for issuance of a registration.

(d) The applicant shall allow reasonable access to the Authority and/or its authorized representatives for the purpose of conducting an on-site survey or inspection of the applicant's proposed manufacturing and/or dispensing facilities.

(e) If the Authority is not satisfied that the applicant should be issued a registration, he or she shall notify the applicant in writing of those factors upon which further evidence is required. Within 30 days of the receipt of such notification, the applicant may submit additional material to the Authority or demand a hearing, or both.

(f) Upon application to the Authority, a registered entity's registration may be amended. The Authority shall consider whether to grant or deny the application for amendment of the

registration utilizing the criteria set forth in this chapter.

(g) The Registration shall have a term of ten (10) years and be renewable under the conditions. set forth in this Chapter.

15.03.160 Applications for Renewal of Registration as Registered Entity

(a) An application to renew any registration issued under this part shall be filed with the Authority not more than six months nor less than four months prior to the expiration thereof. If a renewal application is not filed at least four months prior to the expiration thereof, the Authority may determine that the registration shall have expired and become void on such expiration date.

(b) The application for renewal shall include such information prepared in the manner and detail as the Authority may require, including but not limited to:

(1) Any material changes as determined by the Authority in the information, circumstances or factors listed in this Chapter;

(2) Every known complaint, charge or investigation, pending or concluded during the period of the registration, by any governmental or administrative agency with respect to:

(A) each incident or alleged incidence involving the theft, loss, or possible diversion of medical marijuana manufactured, distributed, or dispensed by the registered entity; and

(B) compliance by the applicant with laws or regulations of the Authority.

(3) Information concerning the applicant's ability to carry on the manufacturing and distributing activity for which it is registered, including but not limited to approved medical marijuana product shortages or wait lists occurring during the registration period; and

(4) A summary of quality assurance testing for all medical marijuana products produced in the prior year including but not limited to the percentage of lots of each brand and form passing all required testing, the percentage of lots failing contaminant testing, the percentage of lots failing brand requirements, all recalls of product lots and all adverse events reported.

(c) If the Authority determines that the applicant's registration should not be renewed, the Authority shall serve upon the applicant or his or her attorney of record, in person or by registered or certified mail, an order directing the applicant to show cause why his or her application for renewal should not be denied. The order shall specify in detail the respects in which the applicant has not satisfied the Authority that the registration should be renewed.

(d) Within ten (10) business days of receipt of such an order, the applicant may submit additional material to the Authority or demand a hearing, or both. If a hearing is demanded, the Authority shall fix a date as soon as reasonably practicable.

(e) If the applicant fails to submit additional material to the Authority within ten (10) business days as requested, and the applicant does not demand a hearing within such time period, the application for renewal of registration shall be denied.

15.03.170 Registrations Non-Transferable

(a) Registrations issued under this part shall be effective only for the registered entity and shall specify:

(1) The name and address of the registered entity;

(2) The name of the contact person for the registered entity;

(3) The activities the registered entity is permitted to perform under the registration for each approved location; and

(4) The real property, buildings and facilities that may be used for the permitted activities of the registered entity.

(b) Registrations are not transferable or assignable, including, without limitation, to another registered entity.

15.03.180 Failure to Operate

(a) A registration shall be surrendered to the Authority upon written notice and demand if the registered entity fails to begin operations, to the satisfaction of the Authority, of a manufacturing and/or dispensing facility within six months of the date of issuance of the registration.

(b) A registered entity who is required to surrender its registration in accordance with this section shall not be entitled to any refund of fees paid to the Authority.

15.03.190 Registered Entities; General Requirements

(a) In addition to other requirements otherwise set forth in this chapter, a registered entity shall comply with the following:

(1) Make its books, records and manufacturing and dispensing facilities available to the Authority or its authorized representatives for monitoring, on-site inspection, and audit purposes, including but not limited to periodic inspections and/or evaluations of facilities, methods, procedures, materials, staff and equipment to assess compliance;

(2) Any deficiencies documented in a statement of findings by the Authority shall require that the registered entity submit a written plan of correction in a format acceptable to the Authority within 15 calendar days of the issue date of the statement of findings. A plan of correction shall address all deficiencies or areas of noncompliance cited in the statement of findings and shall:

(A) contain an assessment and analysis of the events and/or circumstances that led to the noncompliance;

(B) contain a procedure addressing how the registered entity intends to correct each area of noncompliance;

(C) contain an explanation of how proposed corrective actions will be implemented and maintained to ensure noncompliance does not recur;

(D) contain the proposed date by which each area of noncompliance shall be corrected; and

(E) address any inspection finding which the Authority determines jeopardizes the immediate health, safety, or well-being of certified patients, designated caregivers or the public. Such a finding shall be deemed a critical deficiency and shall require immediate corrective action to remove the immediate risk, followed by the submission of a corrective action plan within 24 hours of notification by the Authority of the critical deficiency. The Authority will acknowledge receipt within 24 hours and respond as soon as practicable to notify if the plan is accepted or needs modification. If the corrective action plan needs modification, the registered entity shall modify the plan until it is accepted by the Authority.

(3) Upon written approval of the Authority, the registered entity shall implement the plan of correction.

(4) Only manufacture and dispense approved medical marijuana products in on Tribal Territory in accordance this chapter;

(5) Only manufacture and dispense approved medical marijuana products in an indoor, enclosed, secure facility located on Tribal Territory which may include greenhouses;

(6) Submit approved medical marijuana product samples and manufacturing materials to the Authority upon request, for but not limited to, quality assurance testing or investigation of an adverse event. A subset of each lot of medical marijuana product shall be retained by the registered entity to allow for testing in the future if requested by the Authority and shall be stored unopened as indicated on the label and in the original packaging. This subset of medical marijuana product must be readily identifiable as belonging to its specific lot. The quantity retained shall be a statistically representative number of samples to allow for complete testing of the product at least two times and shall be retained by the registered entity for at least thirty days following the date of expiration.

(7) Implement policies and procedures to notify the Authority within 24 hours of the following:

(A) any adverse events;

(B) any incident involving theft, loss or possible diversion of medical marijuana products;

(C) any suspected or known security breach or other facility event that may compromise public health and/or safety, or which requires response by public safety personnel or law enforcement; and

(D) any vehicle accidents or incidents occurring during transport of medical marijuana products.

(8) Within ten days of the occurrence of one of the above events, the registered entity shall submit a complete written incident report to the Authority detailing the circumstances of the event, any corrective actions taken, and where applicable, confirmation that appropriate law enforcement authorities were notified.

(9) Quarantine any lot of medical marijuana product as directed by the Authority, and not transport, distribute or dispense such lot unless prior approval is obtained from the Authority;

(10) Dispose of unusable medical marijuana products that have failed laboratory testing or any marijuana used in the manufacturing process pursuant to Subchapter 19;

(11) Maintain records for a period of five (5) years, unless otherwise stated, and make such records available to the Authority upon request. Such records shall include:

(A) documentation, including lot numbers where applicable, of all materials used in the manufacturing of the approved medical marijuana product to allow tracking of the materials including but not limited to soil, soil amendment, nutrients, hydroponic materials, fertilizers, growth promoters, pesticides, fungicides, and herbicides;

(B) cultivation, manufacturing, packaging and labeling production records; and

(12) Post the certificate of registration issued by the Authority in a conspicuous location on the premises of each manufacturing facility and dispensing facility.

(b) Registered entities shall not:

(1) Grow marijuana or produce medical marijuana at any site other than a facility or site approved by the Authority and set forth in the registered entity's registration;

(2) Distribute products or samples at no cost except as may be allowed by the Authority;

(3) Make substantial alterations to the structure or architectural design of a manufacturing or dispensing facility without prior written approval of the Authority;

(4) Change the composition of the entity which is the registered entity, including but not limited to, a change in sole proprietor, partner, director, stockholder, member or membership interest of the registered entity without the prior written approval of the Authority;

(5) Materially modify or revise its operating plan, including its policies and procedures related to cultivation, processing, manufacturing, distributing or dispensing policies or procedures, without prior written approval of the Authority;

(6) Locate a dispensing facility on the same street or avenue and within one thousand feet of a building occupied exclusively as a school, church, synagogue or other place of worship. The measurements in this paragraph of this subdivision are to be taken in straight lines from the center of the nearest entrance of the premises sought to be used as a dispensing facility to the center of the nearest entrance of such school, church, synagogue or other place of worship; or

(7) Be managed by or employ anyone who has been convicted of any felony of sale or possession of drugs, narcotics, or controlled substances provided that this provision only applies to:

(A) managers or employees who come into contact with or handle medical marijuana; and

(B) a conviction less than ten years (not counting time spent in incarceration) prior to being employed, for which the person has not received a certificate of relief from disabilities or a certificate of good conduct under applicable correction law.

(c) In the event that a registered entity elects to cease operation of all permitted activities and to surrender its registration, the following provisions shall apply:

(1) The registered entity shall notify the Authority in writing at least 120 days prior to the anticipated date of closure of the manufacturing and each dispensing facility.

(2) Such written notice shall include a proposed plan for closure. The plan shall be subject to Authority approval in accordance with Authority protocols, and shall include timetables and describe the procedures and actions the registered entity shall take to:

(A) notify affected certified patients and designated caregivers of the closure;

(B) properly destroy, transfer or otherwise dispose of all the registered entity's supply of medical marijuana and medical marijuana products;

(C) maintain and make available to the Authority all records required to be maintained under this part for a period of five years; and

(D) maintain compliance with these regulations and any other conditions required by the Authority until the approved closure date.

(3) A registered entity shall take no action to close a manufacturing and dispensing facility prior to Authority approval of the plan for closure.

(4) A registered entity's failure to notify the Authority of intent to cease any operations, failure to submit an approvable plan, and/or to execute the approved plan may result in the imposition of civil penalties, not to exceed $2,000, and shall be a basis for the Authority to revoke the registration of the registered entity under such terms as the Authority determines is appropriate based on public health and safety considerations. In addition, the Authority reserves the right to exercise any other remedies available to it.

(d) If a registered entity's application for renewal of registration is denied, the registered entity shall submit a proposed plan for closure in accordance with this section.

Subchapter 7 Manufacturing Requirements

15.03.200 Definitions

(a) Definitions. Wherever used in this part, the following terms shall have the following meanings:

(1) "Approved medical marijuana product" is the final manufactured product delivered to the patient that represents a specific brand with a defined cannabinoid content and active and inactive ingredients, prepared in a specific dosage and form, to be administered as recommended by the practitioner.

(2) "Brand" means a defined medical marijuana product that has a homogenous and uniform cannabinoid concentration (total THC and total CBD) and product quality, produced according to an approved and stable processing protocol and shall have the same inactive ingredients as that defined for that form of the brand.

(3) "Form" of medical marijuana shall be a type of a medical marijuana product approved by the Authority and shall refer to the final preparation of an approved medical marijuana brand; for example, an extract in oil for sublingual administration, an extract for vaporization or an extract in a capsule for ingestion.

(4) "Lot" means a quantity of a medical marijuana extraction product that has a homogenous and uniform cannabinoid concentration and product quality, produced according to an approved and stable processing protocol specific to that brand and form of medical marijuana product, during the same cycle of manufacture.

(5) "Lot unique identifier (Lot number or bar code)" means any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of manufacturing, testing, holding, distribution or recall of a lot of medical marijuana product can be determined.

(6) "Manufacturing" shall include, but not be limited to cultivation, harvesting, extraction (or other processing), packaging and labeling.

15.03.210 Extraction Standards

(a) A registered entity shall use either carbon dioxide (CO2, super-critical) or alcohol for cannabinoid extraction and shall only perform extraction of the leaves and flowers of female marijuana plants. A registered entity shall only use carbon dioxide that is of a supply equivalent to food or beverage grade of at least 99.5% purity; and alcohol used shall be of a grade that meets or exceeds specifications of official compendiums as defined in section 321 of Title 21 of the United States Code (USC). 21 USC §321. A registered entity shall obtain prior written approval from the Authority if it seeks to use other extraction methods.

15.03.220 Brand Cannabinoid Contents

(a) A registered entity shall only produce such forms of medical marijuana as approved by the Authority according to the following requirements:

(1) Each registered entity may initially produce up to five brands of medical marijuana product with prior approval of the Authority. These brands may be produced in multiple forms as approved by the Authority. Thereafter, additional brands may be approved by the Authority.

(2) Each medical marijuana product brand, in its final form, shall be defined as having a specific concentration of total Tetrahydrocannabinol (THC) and total Cannabidiol (CBD) and shall have a consistent cannabinoid profile. The concentration of the following cannabinoids, at a minimum, must be reported:

(A) Tetrahydrocannabinol (THC)

(B) Tetrahydrocannabinol acid (THCA)

(D) Cannabidiol (CBD)

(E) Cannabinadiolic acid (CBDA)

(F) Cannabidivarine (CBDV)

(G) Cannabinol (CBN)

(H) Cannabigerol (CBG)

(I) Cannabichromene (CBC)

(J) Any other cannabinoid component at > 0.2 percent, for which there is a certified standard available at a customary cost.

(3) The final medical marijuana product shall not contain less than 90 percent or more than 110 percent of the concentration of total THC or total CBD indicated on the label for this brand and shall have no more than 10mg total THC per dose. However:

(4) Where the total THC concentration is less than 5 milligrams per dose, the concentration of total THC shall be within 0.5 milligrams per dose;

(5) Where the total CBD concentration is less than 5 milligrams per dose, the concentration of total CBD shall be within 0.5 milligrams per dose; and

(6) the concentration of total THC and CBD in milligrams per single dose for each sample of a brand lot submitted for testing must be within 25 percent of the mean concentration of total THC and CBD in milligrams per single dose for that submitted lot with the exception that, for brands with a specified total THC and CBD concentration less than 2 milligrams per single dose, the concentration of each sample for that low concentration cannabinoid shall be within 0.5 milligrams per dose of the mean concentration.

(7) The registered entity shall offer and make available to patients at least one brand that has a low THC and a high CBD content (e.g., a 1:20 ratio of THC to CBD).

(8) The registered entity shall offer and make available at least one brand that has approximately equal amounts of THC and CBD.

(9) For each brand offered, the registered entity shall only utilize a distinct name which has been approved by the Authority, consisting of only letters and/or numbers. The name shall not be coined or fanciful, and may not include any "street", slang or other name. No reference shall be made to any specific medical condition.

(10) Each registered entity shall ensure the availability of at least a one-year supply of any offered brand unless otherwise allowed by the Authority.

(b) The registered entity shall not add any additional active ingredients or materials to any approved medical marijuana product that alters the color, appearance, smell, taste, effect or weight of the product unless it has first obtained prior written approval of the Authority. Excipients must be pharmaceutical grade and approved by the Authority.

15.03.230 Agricultural Practices

(a) A registered entity shall:

(1) Use good agricultural practices (GAPS) and must conform to all applicable laws and rules of New York State;

(2) Use water from a public water supply or present a plan, approved by the Authority, which demonstrates the ability to obtain sufficient quantities of water of equal or greater quality as that from a public water supply and to monitor the quality of such water on an ongoing basis;

(3) Upon prior written notice to the Authority, only use pesticides that are registered by the Tribe that specifically meet the United States Environmental Protection Agency registration exemption criteria for Minimum Risk Pesticides;

(4) Process the leaves and flowers of the female plant only, in a safe and sanitary manner;

(5) Perform visual inspection of the harvested plant material to ensure there is no mold, mildew, pests, rot or gray or black plant material;

(6) Have a separate secure area for temporary storage of any medical marijuana or medical marijuana product that needs to be destroyed; and

(7) Provide continual environmental monitoring for temperature, ventilation and humidity at all locations in the manufacturing facility where unprocessed leaf and flower material is stored, until further extraction or other processing is completed.

(b) Production of any approved medical marijuana product shall be in accordance with general sanitary conditions. Poisonous or toxic materials, including but not limited to insecticides, rodenticides, detergents, sanitizers, caustics, acids and related cleaning compounds must be stored in a separate area from the marijuana and medical marijuana products in prominently and distinctly labeled containers, except that nothing herein precludes the convenient availability of detergents or sanitizers to areas where equipment, containers and utensils are washed and sanitized.

15.03.240 Approved Forms of Administration

(a) Approved medical marijuana products shall be limited to the forms of administration approved by the Authority, including but not limited to:

(1) metered liquid or oil preparations;

(2) solid and semisolid preparations (e.g. capsules, chewable and effervescent tablets, lozenges);

(3) metered ground plant preparations; and

(4) topical forms and transdermal patches.

(b) medical marijuana may not be incorporated into food products by the registered entity, unless approved by the Authority.

15.03.250 Packaging

(a) The registered entity shall package the final form of the approved medical marijuana product at the manufacturing site. The original seal shall not be broken except for quality testing at an approved laboratory, for adverse event investigations, by the Authority, by the certified patient or designated caregiver, or by the registered entity for internal quality control testing or disposal.

(b) The registered entity shall package the approved medical marijuana product such that it is child-resistant, tamper-proof/tamper-evident, light-resistant, and in a resealable package that minimizes oxygen exposure.

15.03.260 Product Labelling

(a) Each approved medical marijuana product shall be affixed with a product label. Medical marijuana product labels shall be approved by the Authority prior to use. Each product label shall be applied at the manufacturing facility, be easily readable, firmly affixed and include:

(1) The name, address and registration number of the registered entity;

(2) The medical marijuana product form and brand designation;

(3) The single dose THC and CBD content for the product set forth in milligrams (mg);

(4) The medical marijuana product lot unique identifier (lot number or bar code);

(5) The quantity included in the package;

(6) The date packaged;

(7) The date of expiration of the unopened product, based on stability studies in accordance with this Subchapter, or a tentative expiration date approved by the Authority;

(8) The proper storage conditions;

(9) language stating:

(A) "Medical marijuana products must be kept in the original container in which they were dispensed and removed from the original container only when ready for use by the certified patient";

(B) "Keep secured at all times";

(D) "This product might impair the ability to drive";

(E) "KEEP THIS PRODUCT AWAY FROM CHILDREN (unless medical marijuana product is being given to the child under a practitioner's care"); and

(F) "This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the certifying practitioner, and in the case of breastfeeding mothers, including the infant's pediatrician."

15.03.270 Samples for Lab Analysis

(a) For each lot of medical marijuana product produced, the registered entity shall submit a predetermined number of final medical marijuana products (e.g., sealed vials or capsules; with the number of samples submitted, based on statistical analysis, determined to be representative of the lot) to an independent laboratory/laboratory approved by the Authority. The laboratory verifying the cannabinoid content shall be approved for the analysis of medical marijuana product by the Authority. Such laboratory, or approved laboratories cumulatively, shall certify the medical marijuana product lot as passing all contaminant testing and verify that the content is consistent with the brand prior to the medical marijuana product being released from the manufacturer to any dispensing facility.

(1) Any lot not meeting the minimum standards or specifications for safety shall be rejected and destroyed by the registered entity in accordance with Chapter of this Part.

(2) Any lot not meeting the minimum standards or specifications for brand consistency shall be reported to the Authority and not dispensed by a registered entity without prior written approval from the Authority.

(3) The registered entity shall keep and maintain records documenting submission of medical marijuana products to approved laboratories as required herein, and the results of the laboratory testing. The registered entity shall provide the Authority with such records upon request.

(b) The registered entity shall demonstrate the stability of each approved medical marijuana product produced (each brand in each form) by testing both the unopened and opened product at an approved laboratory under Subchapter 10.

(1) The stability of opened products shall be validated under the conditions (light,

temperature and humidity), specified for storage of the product and an expiration date for opened product shall be determined;

(2) The stability of unopened products (e.g., sealed packages or vials) shall be validated by ongoing stability testing and an expiration date for unopened products shall be determined.

(3) Specifications regarding storage conditions must address storage at the manufacturing facility once the package is sealed, during transport, at the dispensing facility, in the patient's home and for samples retained for future testing.

(c) No synthetic marijuana additives nor any cannabinoid preparation not produced by a registered entity in an approved manufacturing facility shall be used in the production of any medical marijuana product.

(d) The registered entity's approved standard operating procedure for the aforementioned activities must be followed, unless otherwise approved by the Authority.

Subchapter 8 Requirements for Dispensing Facilities

15.03.280 General Requirements

(a) Medical marijuana products shall not be dispensed or handled unless an individual with an active licensed pharmacist license, who has completed a four-hour course pursuant to Subchapter 3 of this chapter, is on the premises and supervising the activity within the facility.

(b) Dispensing facilities shall only sell approved medical marijuana products, related products necessary for the approved forms of administration of medical marijuana, and items that promote health and well-being subject to disapproval of the Authority and only in such a manner as does not increase risks of diversion, theft or loss of approved medical marijuana products or risk physical, chemical or microbial contamination or deterioration of approved medical marijuana products.

(d) Dispensing facilities shall not dispense approved medical marijuana products to anyone other than a certified patient or designated caregiver.

(e) When dispensing approved medical marijuana products, the dispensing facility shall:

(1) Not dispense an amount greater than a thirty (30) day supply to a certified patient, and not until the patient has exhausted all but a seven-day supply provided pursuant to any previously dispensed medical marijuana product by any registered entity;

(2) Ensure that medical marijuana product packaging shall not be opened by dispensing facility staff;

(3) provide a patient specific log of medical marijuana products (brand, administration form, and dosage, and dates dispensed and any return of product) to the patient, the patient's designated caregiver, if applicable, or the patient's practitioner upon request;

15.03.290 Confidentiality and Access

(a) The registered entity shall be responsible for maintaining the confidentiality of patients and the integrity of the security of the facility at all times. Access to medical marijuana storage areas and areas within the dispensing facility where security equipment and recordings are stored shall be restricted to:

(1) Registered entity employees;

(2) Employees of the Authority or its authorized representatives;

(3) Emergency personnel responding to an emergency, and;

(4) Other persons authorized by a manager of the registered entity for the sole purpose of maintaining the operations of the facility.

(b) The dispensing facility shall maintain a visitor log of all persons, other than registered entity employees or emergency personnel responding to an emergency, that access these secured areas, which shall include the name of the visitor, date, time and purpose of the visit. The visitor log shall be available to the Authority at all times during operating hours and upon request.

15.03.300 Product Package Labelling/Safety Inserts

(a) The dispensing facility shall affix to the approved medical marijuana product package a patient specific dispensing label approved by the Authority, that is easily readable, and firmly affixed and includes:

(1) The name and registry identification number of the certified patient and designated caregiver, if any;

(2) The certifying practitioner's name;

(3) The dispensing facility name, address and phone number;

(4) The dosing and administration instructions;

(5) The quantity and date dispensed;

(6) Any recommendation or limitation by the practitioner as to the use of medical marijuana; and

(7) The expiration date of the product once opened;

(b) The dispensing facility shall place the approved medical marijuana product in a plain outer package when dispensing to the patient or designated caregiver.

(c) The dispensing facility shall ensure that each patient receives approved medical marijuana product from no more than two distinct lots for any 30-day supply dispensed.

(d) The dispensing facility shall include with each product package dispensed to a patient, an Authority approved package safety insert. Information provided shall include but not be limited to:

(1) The medical marijuana product and brand;

(2) A list of any excipients used;

(3) A warning if there is any potential for allergens in the medical marijuana product; 4. Contraindications;

(4) More specific dosage directions and instructions for administration;

(5) Warning of adverse effects and/or any potential dangers stemming from the use of medical marijuana;

(6) Instructions for reporting adverse effects as may be determined by the Authority;

(7) A warning about driving, operation of mechanical equipment, child care or making important decisions while under the influence of medical marijuana;

(8) Information on tolerance, dependence and withdrawal and substance abuse, how to recognize what may be problematic usage of medical marijuana and obtain appropriate services or treatment;

(9) Advice on how to keep the medical marijuana product secure;

(10) Language stating that the certified patient may not distribute any medical marijuana product to anyone else;

(11) Language stating that unwanted, excess, or contaminated medical marijuana product must be disposed of according to Subchapter 21 of Ordinance; and

(12) Language stating that "this product has not been analyzed by the FDA. There is limited information on the side effects of using this product and there may be associated health risks."

15.03.310 Product Storage and Returns

(a) The dispensing facility shall store the medical marijuana product in a manner to ensure that there is no contamination or deterioration of the medical marijuana product or its packaging.

(b) If an approved medical marijuana product is returned to the dispensing facility, the dispensing facility shall:

(1) Dispose of such product pursuant to Subchapter 21;

(2) Provide the following information to the Authority:

(A) the name and registry identification number of the certified patient for whom the product was dispensed;

(B) the date of the return;

(D) the quantity and/or weight being returned;

(E) the reason for the return;

(F) the name of the dispensing facility employee accepting the return; and

(G) any other information required by the Authority;

Subchapter 9 Security Requirements for Manufacturing and Dispensing Facilities

15.03.320 General Requirements

(a) All facilities operated by a registered entity, including any manufacturing facility and dispensing facility, shall have a security system to prevent and detect diversion, theft or loss of marijuana and/or medical marijuana products, utilizing commercial grade equipment, which shall, at a minimum, include:

(1) A perimeter alarm;

(2) Motion detectors;

(3) Video cameras in all areas that may contain marijuana and at all points of entry and exit, which shall be appropriate for the normal lighting conditions of the area under surveillance. The manufacturing facility or dispensing facility shall direct cameras at all approved safes, approved vaults, dispensing areas, marijuana sales areas and any other area where marijuana is being manufactured, stored, handled, dispensed or disposed of. At entry and exit points, the manufacturing facility or dispensing facility shall angle cameras so as to allow for the capture of clear and certain identification of any person entering or exiting the facility;

(4) Twenty-four (24) hour recordings from all video cameras, which the manufacturing facility or dispensing facility shall make available for immediate viewing by the Authority or the Authority's authorized representative upon request and shall be retained for at least 90 days. The registered entity shall provide the Authority with an unaltered copy of such recording upon request. If a registered entity is aware of a pending criminal, civil or administrative investigation or legal proceeding for which a recording may contain relevant information, the registered entity shall retain an unaltered copy of the recording until the investigation or proceeding is closed or the entity conducting the investigation or proceeding notifies the registered entity that it is not necessary to retain the recording;

(5) A duress alarm, which for purposes of this section means a silent security alarm system signal generated by the entry of a designated code into an arming station in order to signal that the alarm user is being forced to turn off the system;

(6) A panic alarm, which for purposes of this section, means an audible security alarm system signal generated by the manual activation of a device intended to signal a life threatening or emergency situation requiring a law enforcement response;

(7) A holdup alarm, which for purposes of this section, means a silent alarm signal generated by the manual activation of a device intended to signal a robbery in progress;

(8) An automatic voice dialer or digital dialer, which for purposes of this sectionn, means any electrical, electronic, mechanical, or other device capable of being programmed to send a prerecorded voice message, when activated, over a telephone line, radio or other communication system, to a law enforcement, public safety or emergency services agency requesting dispatch, or other Authority approved industry standard equivalent;

(9) A failure notification system that provides an audible, text or visual notification of any failure in the surveillance system. The failure notification system shall provide an alert to the manufacturing facility or dispensing facility within five minutes of the failure, either by telephone, email, or text message;

(10) The ability to immediately produce a clear color still photo that is a minimum of 9600 dpi from any camera image (live or recorded);

(11) A date and time stamp embedded on all recordings. The date and time shall be synchronized and set correctly and shall not significantly obscure the picture; and

(12) The ability to remain operational during a power outage.

(b) A registered entity shall ensure that any manufacturing facility and dispensing facility maintains all security system equipment and recordings in a secure location so as to prevent theft, loss, destruction or alterations.

15.03.330 Additional Security Requirements

(a) In addition to the requirements listed above in this section, each manufacturing facility and dispensing facility shall have a back-up alarm system approved by the Authority that shall detect unauthorized entry during times when no employees are present at the facility and that shall be provided by a company supplying commercial grade equipment.

(b) A registered entity shall limit access to any surveillance areas solely to persons that are essential to surveillance operations, law enforcement agencies, security system service employees, the Authority or the Authority's authorized representative, and others when approved by the Authority. A registered entity shall make available to the Authority or the Authority's authorized representative, upon request, a current list of authorized employees and service employees who have access to any surveillance room. A manufacturing facility and dispensing facility shall keep all on-site surveillance rooms locked and shall not use such rooms for any other function.

(c) A registered entity shall keep illuminated the outside perimeter of any manufacturing facility and dispensing facility that is operated under the registered entity's license.

(d) All video recordings shall allow for the exporting of still images in an industry standard image format (including .jpeg, .bmp, and .gif). Exported video shall have the ability to be archived in a proprietary format that ensures authentication of the video and guarantees that no alteration of the recorded image has taken place. Exported video shall also have the ability to be saved in an industry standard file format that can be played on a standard computer operating system. A registered entity shall erase all recordings prior to disposal or sale of the facility.

(e) A registered entity shall keep all security equipment in full operating order and shall test such equipment no less than semi-annually at each manufacturing facility and dispensing facility that is operated under the registered entity's registration. Records of security tests must be maintained for five years and made available to the Authority upon request.

(f) The manufacturing facility of the registered entity must be securely locked and protected from unauthorized entry at all times.

(1) The registered entity shall be responsible for ensuring the integrity of the security of the manufacturing facility and the maintenance of sanitary operations when permitting access to the facility.

(2) The manufacturing facility shall maintain a visitor log of all persons other than registered entity employees or emergency personnel responding to an emergency that access any secured areas, which shall include the name of the visitor, date, time and purpose of the visit. The visitor log shall be available to the Authority at all times during operating hours and upon request.

15.03.340 Storage of Marijuana

(a) All marijuana must be stored in a secure area or location within the registered entity accessible to the minimum number of employees essential for efficient operation and in such a manner as approved by the Authority in advance, to prevent diversion, theft or loss.

(1) Registered entities shall return marijuana to its secure location immediately after completion of manufacture, distribution, transfer or analysis.

(b) All medical marijuana must be stored in such a manner as to protect against physical, chemical and microbial contamination and deterioration of the product.

(c) All approved safes, vaults or any other approved equipment or areas used for the manufacturing or storage of marijuana and approved medical marijuana products must be securely locked or protected from entry, except for the actual time required to remove or replace marijuana or approved medical marijuana products.

(d) Keys shall not be left in the locks or stored or placed in a location accessible to individuals who are not authorized access to marijuana or manufactured medical marijuana products.

(e) Security measures, such as combination numbers, passwords or biometric security systems, shall not be accessible to individuals other than those specifically authorized to access marijuana or manufactured medical marijuana products.

15.03.350 Transporting Marijuana

(a) Prior to transporting any medical marijuana, a registered entity shall complete a shipping manifest using a form determined by the Authority.

(1) A copy of the shipping manifest must be transmitted to the destination that will receive the products and to the Authority at least two business days prior to transport unless otherwise expressly approved by the Authority.

(2) The registered entity shall maintain all shipping manifests and make them available to the Authority for inspection upon request, for a period of 5 years.

(3) Approved medical marijuana products must be transported in a locked storage compartment that is part of the vehicle transporting the marijuana and in a storage compartment that is not visible from outside the vehicle.

(b) An employee of a registered entity, when transporting approved medical marijuana products, shall travel directly to his or her destination(s) and shall not make any unnecessary stops in between.

(d) A registered entity shall staff all transport vehicles with a minimum of two employees. At least one transport team member shall remain with the vehicle at all times that the vehicle contains approved medical marijuana products.

(e) A transport team member shall have access to a secure form of communication with employees at the registered entity's manufacturing facility at all times that the vehicle contains approved medical marijuana products.

(f) A transport team member shall possess a copy of the shipping manifest at all times when transporting or delivering approved medical marijuana products and shall produce it to the Authority, the Authority's authorized representative or law enforcement official upon request.

Subchapter 10 Laboratory Testing Requirements for Medical Marijuana

15.03.360 General Requirements

(a) Medical marijuana products produced by a registered entity shall be examined in a laboratory approved for the analysis of medical marijuana by the Authority.

(b) No Advisory Board member, officer, manager, owner, partner, principal stakeholder or member of a registered entity, or such persons' immediate family member, shall have an interest or voting rights in the laboratory performing medical marijuana testing.

(c) For final product testing, the registered entity shall submit to the laboratory a statistically significant number of samples containing the final medical marijuana product equivalent to the sealed medical marijuana product dispensed to the patient (e.g., liquid extract in a sealed bottle or intact sealed bottle of capsules). Upon prior written approval of the Authority, a registered entity may submit to the laboratory the final medical marijuana product sample packaged in a quantity less than that which would be provided to the patient if the sample is prepared and packaged in the identical manner as the product provided to the patient.

(d) Testing of the final medical marijuana product is mandatory. However, at the option of the registered entity, testing may be performed on components used for the production of the final medical marijuana product including but not limited to water or growing materials. Testing may also be performed on the final marijuana extract e.g. for cannabinoid profile verification or contaminant testing.

15.03.370 Testing of Lots

(a) Sampling and testing of each lot of final medical marijuana product shall be conducted with a statistically significant number of samples and with acceptable methodologies, approved by the Authority, such that there is assurance that all lots of each medical marijuana product are adequately assessed for contaminants and the cannabinoid profile is consistent throughout.

(b) Testing of the cannabinoid profile shall include, at a minimum, those analytes in Subchapter 8.

(c) Testing for contaminants in the final medical marijuana product shall include but shall not be limited to those analytes listed below. The Authority shall make available a list of required analytes and their acceptable limits as determined by the Authority.

Analyte:

coli

Pseudomonas (for products to be vaporized)

Salmonella species

Enterococcus species

Bile tolerant gram negative bacteria, specifically including Klebsiella species

Clostridium botulinum

Aspergillus species

Mucor species

Penicillium species

Thermophilic Actinomycetes species

Aflatoxins B1, B2, G1, G2

Ochratoxin A

Antimony

Arsenic

Cadmium

Chromium

Copper

Lead

Nickel

Zinc

Mercury

Any pesticide used during production of the medical marijuana product

Any growth regulator used during production of the medical marijuana product

Any other analyte as required by the Authority

15.03.380 Final Product/Stability Testing

(a) Laboratories performing final product testing pursuant to this section must report all results to the Authority, in a manner and timeframe prescribed by the Authority.

(b) Stability testing shall be performed on each brand and form of medical marijuana product as follows:

(1) For testing of open products, stability testing shall be performed for each extract lot, at time zero when opened and then, at a minimum, at 60 days from the date of first analysis. This shall establish use of the product lot within a specified time once opened.

(2) For testing of unopened products, until stability studies have been completed, a registered entity may assign a tentative expiration date based on available stability information. The registered entity must concurrently have stability studies conducted by an approved laboratory to determine the actual expiration date of an unopened product.

(3) For stability testing of both opened and unopened products, each brand shall retain a total THC and total CBD concentration in milligrams per single dose that is required in Subchapter 7. If stability testing demonstrates that a product no longer retains a consistent concentration of THC and CBD pursuant to Subchapter 8 the product shall be deemed no longer suitable for dispensing or consumption. The Authority may request further stability testing of a brand to demonstrate the ongoing stability of the product produced over time.

(4) The Authority may waive any of the requirements of this subsection upon good cause shown.

(c) The laboratory shall track and use an approved method to dispose of any quantity of medical marijuana product that is not consumed in samples used for testing. Disposal of medical marijuana shall mean that the medical marijuana has been rendered unrecoverable and beyond reclamation.

(d) Any submitted medical marijuana products that are deemed unsuitable for testing shall be returned to the registered entity under chain of custody.

Subchapter 11 Pricing

15.03.390 Definitions

(a) For purposes of this section, the following terms have the following meanings:

(1) "Cost analysis" shall mean the review and evaluation of the separate cost elements and profit of a proposed price and the application of judgment to determine how well the proposed costs represent what the price per unit for approved medical marijuana products should be, assuming reasonable economy and efficiency.

(2) "Price" shall mean the cost to manufacture, market and distribute approved medical marijuana products plus a reasonable profit.

15.03.400 Determination of Price

(a) A registered entity shall only charge a price for an approved medical marijuana product that has been approved by the Authority.

(b) The Authority shall set the per unit price of each form of approved medical marijuana product sold by any registered entity, as follows:

(1) Registered entities shall submit a proposed price per unit for each form of medical marijuana indicated in its registration. Registered entities shall submit such information and documentation, in a manner and format determined by the Authority, sufficient for the Authority to perform a cost analysis of the proposed price. In particular, the registered entity shall, in a manner and format determined by the Authority, provide a detailed breakdown of, and submit information and documentation concerning, all costs it factored to arrive at its proposed price, including but not limited to its fixed and variable costs such as materials and services; direct labor; and indirect costs.

(2) The registered entity shall provide cost or pricing data that is accurate and reliable, and shall certify, at the time of submission of its price proposal, that to the best of its knowledge and belief, the cost or pricing data were accurate, complete, and current as of the date of submission.

(3) The Authority shall determine the reasonableness of the proposed costs. In making this determination, the Authority may consider whether the costs represent inefficient and uneconomical practices; are not costs appropriately attributable to the price; and/or are costs unsupported by sufficient documentation or information to justify their inclusion in the proposed price. If the registered entity has been granted a renewal of its registration, any relevant historical price, cost and/or sales data of the registered entity; and any other information the Authority deems appropriate.

(4) The Authority may approve the proposed price, refuse approval of a proposed price, or modify or reduce the proposed price.

15.03.410 Examination of Records/Data

(a) The registered entity shall grant the Authority or the Authority's authorized representative the right to examine records that formed the basis for the proposed price, including the registered entity's books, records, documents and other types of factual information that will permit an adequate evaluation of the proposed price.

(b) Correction of Insufficient Price Data. If the registered entity or Authority determines that the cost or pricing data submitted is inaccurate, incomplete or noncurrent prior to the Authority's approval of the price, the registered entity shall submit new data to correct the deficiency, or consider the inaccuracy, incompleteness, or noncurrency of the data.

15.03.420 Duration of Price Determination

(a) The Authority's approved price shall be in effect for the entire period of the registered entity's registration; provided, however, that at the conclusion of the first year of the registration period, or prior to that time based upon documented exceptional circumstances, the registered entity may request that the price be modified based upon a material change in the registered entity's costs. The registered entity shall fully support its request with sufficient information and documentation, in a manner and format determined by the Authority, to justify its request. If the Authority denies such request, the registered entity shall only charge prices previously approved by the Authority.

(b) If the Authority has approved a price, the registered entity shall immediately notify the Authority of any cost or pricing data submitted that it determines was inaccurate, incomplete, or noncurrent as of the date of the Authority's approval of the price. If the registered entity provides such notice, or if the Authority independently learns of such inaccurate, incomplete or noncurrent data, the Authority may require the registered entity to provide new data to correct the deficiency, or consider the inaccuracy, incompleteness, or noncurrency of the data. The Authority may adjust the price per dose if the defective data significantly increased the price approved by the Authority.

15.03.430 Audits

(a) The Authority may perform audits, which may include site visits. The registered entity shall provide reasonable access to the Authority of its facilities, books and records.

Subchapter 12 Medical Marijuana Marketing and Advertising by Registered Entities

15.03.440 No Advertising on Physical Structures

(a) All physical structures owned, leased or otherwise utilized by a registered entity, including any dispensing facility, shall:

(1) Not advertise medical marijuana brand names or utilize graphics related to marijuana or paraphernalia on the exterior of the physical structures; and

(2) Not display medical marijuana products and paraphernalia so as to be clearly visible from the exterior of a physical structure.

(b) All restrictions listed in Subsection (a), above. shall apply to any item located on any real property on which a registered entity's physical structures is located.

(c) All restrictions listed in Subsection (a), above, shall apply to all vehicles owned, leased or utilized by a registered entity.

15.03.450 No Advertisement as to Effectiveness of Products

(a) All advertisements, regardless of form, for approved medical marijuana products that make a statement relating to effectiveness, side effects, consequences or contraindications shall present a true and accurate statement of such information.

(b) An advertisement does not satisfy the requirement that it presents a "true and accurate statement" of information relating to effectiveness, side effects, consequences, and contraindications if it fails to present a fair balance between information relating to effectiveness, side effects, consequences, and contraindications in that the information relating to effectiveness is presented in greater scope, depth, or detail than is the information relating to side effects, consequences and contraindications, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.

15.03.460 Misleading Advertisements

(a) An advertisement is false, lacking in fair balance, or otherwise misleading if it:

(1) Contains a representation or suggestion that one marijuana brand or form is better, more effective, useful in a broader range of conditions or patients or safer than other drugs or treatments including other marijuana brands or forms, unless such a claim has been demonstrated by substantial scientific or clinical experience;

(2) Contains favorable information or opinions about a marijuana product previously regarded as valid but which have been rendered invalid by contrary and more credible recent information;

(3) Uses a quote or paraphrase out of context or without citing conflicting information from the same source, to convey a false or misleading idea;

(4) Uses a study on persons without a debilitating medical condition without disclosing that the subjects were not suffering from a debilitating medical condition;

(5) Uses data favorable to a marijuana product derived from patients treated with a different product or dosages different from jurisdictions;

(6) Contains favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions; or

(7) Fails to provide adequate emphasis for the fact that two or more facing pages are part of the same advertisement when only one page contains information relating to side effects, consequences and contraindications.

(b) False or misleading information in any part of the advertisement shall not be corrected by the inclusion of a true statement in another distinct part of the advertisement.

(1) Any statement that is false or misleading;

(2) Any statement that falsely disparages a competitor's products;

(3) Any statement, design, or representation, picture or illustration that is obscene or indecent;

(4) Any statement, design, representation, picture or illustration that encourages or represents the use of marijuana for a condition other than a qualifying condition as defined in Section 15.03.090(a)(8)-Section 15.03.090(a)(9);

(5) Any statement, design, representation, picture or illustration that encourages or represents the recreational use of marijuana;

(6) Any statement, design, representation, picture or illustration related to the safety or efficacy of marijuana, unless supported by substantial evidence or substantial clinical data;

(7) Any statement, design, representation, picture or illustration portraying anyone under the age of 18, objects suggestive of the presence of anyone under the age of 18, or containing the use of a figure, symbol or language that is customarily associated with anyone under the age of 18;

(8) Any offer of a prize, award or inducement to a certified patient, designated caregiver or practitioner related to the purchase of marijuana or a certification for the use of marijuana; or

(9) Any statement that indicates or implies that the product or entity in the advertisement has been approved or endorsed by the Authority, New York State or any other jurisdiction, provided that this shall not preclude a factual statement that an entity is a registered entity.

15.03.470 Submitting Advertisements for Approval

(a) Any advertisement for an approved medical marijuana product, which makes any claims or statements regarding efficacy, must be submitted to the Authority at least 10 business days prior to the public dissemination of the advertisement.

(b) The submitter of the advertisement must provide the following information to the Authority in addition to the advertisement itself:

(1) A cover letter that:

(A) provides the following subject line: Medical marijuana advertisement review package for a proposed advertisement;

(B) provides a brief description of the format and expected distribution of the proposed advertisement; and

(2) An annotated summary of the proposed advertisement showing every claim being made in the advertisement and which references support for each claim;

(3) Verification that a person identified in an advertisement as an actual patient or health care practitioner is an actual patient or health care practitioner and not a model or actor;

(4) Verification that a spokesperson who is represented as an actual patient is indeed an actual patient;

(5) Verification that an official translation of a foreign language advertisement is

accurate;

(6) Annotated references to support disease or epidemiology information, cross- referenced to the advertisement summary; and

(7) A final copy of the advertisement, including a video where applicable, in a format acceptable to the Authority.

(c) Advertising packages that are missing any of the elements in Subsection (b) above, or that fail to follow the specific instructions for submissions, shall be considered incomplete. If the Authority receives an incomplete package, it shall so notify the submitter.

(d) No advertisement may be disseminated if the submitter of the advertisement has received information that has not been widely publicized in medical literature that the use of any approved medical marijuana product may cause fatalities or serious damage to a patient.

15.03.480 Other Requirements

(a) A registered entity, its officers, managers and employees shall not cooperate, directly or indirectly, in any advertising if such advertising has the purpose or effect of steering or influencing patient or caregiver choice with regard to the selection of a practitioner. Nothing contained within this section prevents a registered entity from educating practitioners about approved medical marijuana products offered by the registered entity.

(b) The Authority may:

(1) Require a specific disclosure be made in the advertisement in a clear and conspicuous manner if the Authority determines that the advertisement would be false or misleading without such a disclosure; or

(2) Require that changes be made to the advertisement that are:

(A) necessary to protect the public health, safety and welfare; or

(B) consistent with dispensing information for the product under review.

Subchapter 13 Reporting Dispensed Medical Marijuana Products

15.03.490 General Requirements

(a) A record of all approved medical marijuana products that have been dispensed shall be filed electronically with the Authority, utilizing a transmission format acceptable to the Authority, not later than 24 hours after the marijuana was dispensed to the certified patient or designated caregiver.

(b) The information filed with the Authority for each approved medical marijuana product dispensed shall include but not be limited to:

(1) A serial number that will be generated by the dispensing facility for each approved medical marijuana product dispensed to the certified patient or designated caregiver;

(2) An identification number which shall be populated by a number provided by the Authority, to identify the registered entity's dispensing facility;

(3) The patient name, date of birth and sex;

(4) The patient address, including street, city, state, zip code;

(5) The patient's registry identification card number;

(6) If applicable, designated caregiver's name and registry identification card number;

(7) The date the approved medical marijuana product was filled by the dispensing facility;

(8) The metric quantity for the approved medical marijuana product;

(9) The medical marijuana product drug code number, which shall be populated by a number provided by the Authority, to represent the approved medical marijuana brand that was dispensed to the certified patient or designated caregiver, as applicable;

(10) The number of days' supply dispensed;

(11) The registered practitioner's Drug Enforcement Administration number;

(12) The date the written certification was issued by the registered practitioner; and

(13) The payment method.

(c) When applicable, a registered entity shall file a zero report with the Authority, in a format acceptable to the Authority. For the purposes of this section, a zero report shall mean a report that no approved medical marijuana product was dispensed by a registered entity during the relevant period of time. A zero report shall be submitted no later than 14 days following the most recent previously reported dispensing of an approved medical marijuana product or the submission of a prior zero report.

Subchapter 14 Prohibiting the Use of Approved Medical Marijuana Products in Certain Places

15.03.500 General Requirements

(a) Approved medical marijuana products shall not be vaporized in a public place. In no event shall approved medical marijuana products be consumed through vaporization in any location in which smoking is prohibited under tribal law, including:

(1) Places of employment;

(2) Bars;

(3) Food service establishments;

(4) Enclosed indoor areas open to the public containing a swimming pool;

(5) Public means of mass transportation, including, buses, vans, taxicabs and limousines;

(6) Ticketing, boarding and waiting areas in public transportation terminals;

(7) Youth centers and facilities for detention;

(8) Any facility that provides child care services;

(9) Child day care centers;

(10) Group homes for children;

(11) Residential treatment facilities for children and youth;

(12) All public and private colleges, universities and other educational and vocational institutions, including dormitories, residence halls, and other group residential facilities that are owned or operated by such colleges, universities and other educational and vocational institutions;

(13) General hospitals and residential health care facilities;

(14) Commercial establishments used for the purpose of carrying on or exercising any trade, profession, vocation or charitable activity;

(15) Indoor arenas;

(16) Zoos;

(17) Bingo facilities

(b) Vaporization of approved medical marijuana products shall not be permitted and no person shall vaporize an approved medical marijuana product within one hundred feet of the entrances, exits or outdoor areas of any public or private elementary or secondary schools; however, that the provisions of this Subsection shall not apply to vaporization in a residence, or within real property boundary lines of such residential real property.

(c) Consumption of approved medical marijuana product shall not be permitted in any motor vehicle, either public or private, that is located upon public highways, private roads open to motor vehicle traffic, parking area of a shopping center or any parking lot.

Subchapter 15 Reporting Requirements for Registered Practitioners, Certified Patients and Designated Caregivers

15.03.510 Death or Change in Serious Condition

(a) A practitioner shall report to the Authority, in a manner determined by the Authority, the death of a certified patient or change in status of a qualifying condition involving a certified patient for whom the practitioner has issued a certification if such change may affect the patient's continued eligibility for certification for use of approved medical marijuana product. A practitioner shall report such death or change of status not more than five (5) business days after the practitioner becomes aware of such fact.

(b) If a practitioner re-issues a patient's certification to terminate the certification on an earlier date, then the registry identification card shall expire on such earlier date and shall be promptly returned to the Authority by the certified patient or designated caregiver.

(c) A practitioner shall report patient adverse events to the Authority, in a manner determined by the Authority, not more than five business days after the practitioner becomes aware of such adverse event, except that serious adverse events shall be reported not more than one business day after the practitioner becomes aware of such adverse event.

(d) A certified patient or designated caregiver, who has been issued a registry identification card, shall notify the Authority of any change in the information provided to the Authority not later than ten (10) business days after such change. A certified patient or designated caregiver shall report changes that include, but are not limited to, a change in the certified patient's name, address, contact information, medical status. A certified patient or designated caregiver shall report such changes on a form, and in a manner, determined by the Authority. Should a certified patient cease to have the qualifying condition noted on his or her certification, the certified patient or designated caregiver shall notify the Authority of such within 10 days and the certified patient's and designated caregiver's registry identification cards shall be considered void and shall be returned promptly to the Authority.

(e) If a certified patient's or designated caregiver's appearance has substantially changed such that the photograph submitted to the Authority does not accurately resemble such certified patient or designated caregiver, such person shall submit, in a timely manner, an updated photograph that meets the requirements set forth by the Authority.

15.03.520 Reporting by Designated Caregivers

(a) If a certified patient has a designated caregiver, that designated caregiver may notify the Authority of any changes on behalf of the certified patient using the same forms and process prescribed for certified patients.

(b) If a certified patient or designated caregiver notifies the Authority of any change that results in information on the registry identification card being inaccurate or the photograph needing to be replaced, the certified patient or designated caregiver shall obtain a replacement registry identification card. The Authority shall thereafter issue the certified patient or designated caregiver a new registry identification card. Upon receipt of a new registry identification card, the certified patient or designated caregiver shall destroy in a non-recoverable manner the registry identification card that was replaced.

(c) If a certified patient or designated caregiver becomes aware of the loss, theft or destruction of the registry identification card of such certified patient or designated caregiver, the certified patient or designated caregiver shall notify the Authority, on a form and in a manner prescribed by the Authority, not later than ten days of becoming aware of the loss, theft or destruction. The Authority shall inactivate the initial registry identification card upon receiving such notice and issue a replacement registry identification card upon receiving the applicable fee provided the applicant continues to satisfy the requirements of this chapter. Prior to issuance of the first replacement registry identification card, a certified patient or designated caregiver shall submit to the Authority a fee of $25, transmitted in a fashion as determined by the Authority. For each subsequent replacement registry identification card, a certified patient or designated caregiver shall submit to the Authority a fee of $50, transmitted in a fashion as determined by the Authority.

15.03.530 Change in or Termination of Designated Caregiver

(a) If a certified patient wishes to change or terminate his or her designated caregiver, the certified patient shall notify the Authority, in a manner determined by the Authority, and shall notify his or her designated caregiver as soon as practicable.

(1) The Authority shall issue a notification, in a format determined by the Authority, to the designated caregiver and the certified patient that the designated caregiver's registration card is invalid;

(2) In the event that the designated caregiver has no other active certified patients, the designated caregiver's registration card must be returned to the Authority within 10 business days;

(3) In the event that the certified patient has selected another designated caregiver, the proposed designated caregiver must register with the Authority as defined in Subchapter 4.

(b) If a designated caregiver wishes to terminate his or her relationship with a certified patient, the designated caregiver shall notify the Authority, in a manner determined by the Authority, and shall notify the certified patient, as soon as practicable.

(1) The Authority shall issue a notification, in a format determined by the Authority, to the certified patient and the designated caregiver that the designated caregiver has terminated his or her relationship with the certified patient.

(2) In the event that the designated caregiver has no other active certified patients, the designated caregiver's registration card must be returned to the Authority within ten business days.

Subchapter 16 Proper Disposal of Medical Marijuana Products by Certified Patients or Designated Caregivers

15.03.540 General Requirements

(a) A certified patient or designated caregiver shall dispose of all approved medical marijuana product in the certified patient's or designated caregiver's possession no later than ten calendar days after the expiration of the patient's certification, if such certification is not renewed, or sooner should the patient no longer wish to possess medical marijuana.

(b) A certified patient or designated caregiver shall complete disposal of approved medical marijuana products by one of the following methods:

(1) Rendering the approved medical marijuana product non-recoverable beyond reclamation in accordance with the Authority's guidance; or;

(2) Returning the approved medical marijuana product to the dispensing facility from which it was purchased or any dispensing facility associated with the registered entity which manufactured the approved medical marijuana product, to the extent that the registered entity accepts product returns.

Subchapter 17 General Prohibitions

15.03.550 General Prohibitions

(a) No person, except for a certified patient or designated caregiver or an approved laboratorian shall open or break the seal placed on an approved medical marijuana product packaged by a registered entity and provided to a certified patient.

(b) No person associated with a registered entity shall enter into any agreement with a registered practitioner or health care facility concerning the provision of services or equipment that may adversely affect any person's freedom to choose the dispensing facility at which the certified patient or designated caregiver will purchase approved medical marijuana products.

(c) No approved medical marijuana product shall be sold, dispensed or distributed via a delivery service without prior written approval to the registered entity by the Authority, except that a designated caregiver may deliver the approved medical marijuana product to the designated caregiver's certified patient.

(d) No employee of a registered entity shall counsel a certified patient or designated caregiver on the use, administration of, and the risks associated with approved medical marijuana products, unless the employee is a physician, nurse practitioner, physician assistant or pharmacist approved under this chapter, or the employee is under the direct supervision of, and in consultation with, such physician, nurse practitioner, physician assistant, or the pharmacist on-site in the dispensing facility.

(e) No certified patient or designated caregiver shall be in possession of approved medical marijuana products without having in his or her possession his or her registry identification card. The certified patient or designated caregiver, upon request by the Authority or law enforcement, shall present such card to verify that the certified patient or designated caregiver is authorized to possess approved medical marijuana products.

Subchapter 18 Practitioner Prohibitions

15.03.560 General Prohibitions

(a) A practitioner that is registered with the Authority shall not:

(1) Directly or indirectly accept, solicit, or receive any item of value from a registered entity;

(2) Offer a discount or any other item of value to a certified patient based on the patient's agreement or decision to use a particular practitioner, registered entity, brand or specific form of approved medical marijuana product produced by a registered entity;

(3) Examine a qualifying patient for purposes of diagnosing a debilitating medical condition at any location owned or operated by a registered entity, or where medical marijuana products or related products necessary for the approved forms of administration of medical marijuana are acquired, distributed, dispensed, manufactured, sold, or produced; or

(4) Directly or indirectly benefit from a patient obtaining a written certification. Such prohibition shall not prohibit a practitioner from charging an appropriate fee for the patient visit.

15.03.570 No Financial Interests, Conflicts

(a) A practitioner that issues written certifications, and such practitioner's co-worker, employee, spouse, parent, child, or sibling shall not have a direct or indirect financial interest in a registered entity or any other entity that may benefit from a certified patient's or designated caregiver's acquisition, purchase or use of approved medical marijuana products, including any formal or informal agreement whereby a registered entity provides compensation if the practitioner issues a written certification for a certified patient or steers a certified patient to a specific dispensing facility.

(b) A practitioner shall not issue a certification for himself/herself or for the practitioner's family members, employees or co-workers.

(d) A practitioner shall not be a designated caregiver for any patients that he or she has certified under this chapter.

Subchapter 19 Designated Caregiver Prohibitions and Protections

15.03.580 General Requirements

(a) An individual shall not serve as a designated caregiver for more than five certified patients at any given time.

(b) A designated caregiver may only obtain payment from the certified patient to be used for the cost of the approved medical marijuana product purchased for the certified patient in the actual amount charged by the registered entity; provided, however, that a designated caregiver may charge the certified patient for reasonable costs incurred in the transportation, delivery, storage and administration of approved medical marijuana products.

(c) Designated caregivers acting within their scope of employment shall not be subject to arrest, prosecution, or penalty in any manner, or denied any right or privilege, including but not limited to civil penalty or disciplinary action by a business or occupational or professional licensing board or bureau, solely for an action or conduct in accordance with this chapter.

Subchapter 20 Registered Entities; Disposal of Medical Marijuana

15.03.590 General Requirements

(a) The disposal of medical marijuana shall mean that the medical marijuana has been rendered unrecoverable and beyond reclamation.

15.03.600 Approval by Authority

(a) Registered entities must dispose of any medical marijuana that is outdated, damaged, deteriorated, contaminated or otherwise deemed not appropriate for manufacturing or dispensing, or any plant-based waste created as a by-product of the manufacturing processes. Registered entities shall:

(1) Obtain Authority approval of disposal methods; and

(2) Dispose of liquid and chemical waste in accordance with applicable tribal or federal laws and regulations.

15.03.610 Records

(a) Registered entities shall maintain records of disposal, which shall include:

(1) The type of plant material being disposed, if the material is a by-product of the manufacturing process;

(2) The brand and form of approved medical marijuana product being disposed, if a finished product;

(3) The weight of the disposed material, the number of plants, or in the case of a finished product, the quantity of the disposed product; and

(4) The signatures of at least two registered entity staff members who witnessed the disposal.

(b) All records of disposal shall be retained for at least five years and be made available for inspection by the Authority.

Subchapter 21 Miscellaneous

15.03.620 Sovereign Immunity

(a) Nothing in this chapter shall be interpreted as waiving or diminishing the sovereign immunity of the Saint Regis Mohawk Tribe or its subordinate entities, agencies, officers, agents, employees, instrumentalities, or authorize in any form a prospective waiver of such sovereign immunity.

(b) Tribal sovereign immunity is hereby found and stated to be an essential element of self- determination and self-government; and as such will be waived by the Tribal Council only under such circumstances as the Tribal Council finds to be in the interests of the Tribe in promoting economic or commercial development or for other Tribal purposes. Any such specific waivers shall be interpreted narrowly and limited to the explicit terms of the waivers; and any such waivers shall not by implication or interpretation be extended in any manner or fashion beyond their narrow, explicit terms.

15.03.630 Regulations

(a) The Authority may issue Regulations as appropriate for the proper administration of this chapter. Regulations will be approved by the Tribal Council pursuant to the rules applicable to approval of Tribal Ordinances with the circulation of Draft regulations and public meeting for comments.

15.03.640 Effective Date

(a) The effective date of this chapter shall be the approval of the Ordinance by the Tribal Council after it has been approved by Referendum vote.

15.03.650 Amendments

(a) This chapter may be amended by: (1) a duly conducted Referendum; or (2) by the Authority or Advisory Board recommending amendment, provided the amendment is confirmed by a vote of the Tribal Council. The amendment shall be processed following the Tribal Procedure Act and include notice to, and review by, the Community.

(b) An amendment may include an agreement entered into by the Tribe with the State or other governmental agency needed to effectuate or implement this chapter. Such Amendments will be processed following the Tribal Procedure Act and include notice to, and review by, the Community.

15.03.660 Severability

(a) The provisions of this chapter shall be severable and if any part or provision shall be held void by any Court of competent jurisdiction, the decision of the Court so holding shall not affect or impair any of the remaining parts or provisions of this chapter.

15.03.670 Repeal of Prior Laws

(a) This chapter repeals any other Tribal Council Resolutions, Ordinances, Acts or Laws that are inconsistent herein.