18-691-2 Me. Code R. § 10

Current through 2024-51, December 18, 2024

Section 691-2-10 - COMPLIANCE and ENFORCEMENT

A. Compliance and enforcement. Compliance and enforcement are governed by this rule and the statute. The Department may refer criminal activity that is outside the scope of this rule and the statute to law enforcement.

1. An individual who engages in conduct authorized by this rule is subject to a review conducted by the Department to assess compliance with statute and rule.

2. Submission of an application for a registry identification card constitutes permission for a criminal history record check and on-site assessments which may include inspections to ensure compliance.

3. Any patient, primary caregiver or cardholder must comply with the Department's request for evidence of authorized conduct and to inspect the premises and records, as appropriate, to assess compliance with this rule and the statute.

4. Failure to comply with provisions of statute and rule may result in remedial action up to, and including, directed corrective action; suspension, revocation and denial of a registry identification card or registration certificate; civil penalties; and referral to the appropriate agency, department or entity if the conduct is determined to be outside the scope of MMMP, is not appropriate for agency directed corrective action, or has not been rectified through correction action.

B.On-site assessment. The Department may initiate an on-site assessment, in accordance with the statute and this rule to ensure compliance prior to issuing a registry identification card, as a routine review, in response to an allegation of non-compliance or as part of a plan of correction.

1. During an on-site assessment, the primary focus of the Department will be:

a. Verifying information submitted in an application;

b. Reviewing records for all required documents, including, but not limited to designation forms, registration, and licenses, labeling and employee records, as applicable;

c. Conducting interviews;

d. Entering areas used for conduct authorized by this rule and the statute to ensure any marijuana, including plants, usable marijuana and incidental marijuana cultivated for medical use, is within the specified limit and is identifiable and maintained as required;

e. Taking samples of marijuana cultivated for medical use and products containing marijuana for medical use; and

f. Assessing conduct for compliance with the rule and statute.

2.Notification of an on-site assessment. No prior notice is required for the Department to initiate an on-site assessment to determine compliance.

3.Entry to inspect premises during an on-site assessment.

a.Inspection of a registered dispensary. In accordance with 22 M.R.S. §2428(5), the Department may enter the dispensary and the one permitted additional location at which the dispensary cultivates marijuana at any time, without notification, to carry out an inspection.

b.Inspection of a registered primary caregiver. When the Department wants entry into an area reportedly used by a registered primary caregiver for conduct authorized by this rule to carry out an on-site assessment, the Department is not required to provide prior notification to the registered primary caregiver, including those who elect to cultivate at his or her residence.

i.Exception: registered inpatient hospice facility or nursing facility. The Department will provide a minimum of 24 hours' notice before entering an inpatient hospice facility or nursing facility registered as a primary caregiver.

c.Inspection of a residence. When the Department determines entry into and inspection of areas within a person's residence reportedly used for conduct authorized by this rule is necessary to ensure compliance, the Department will provide a notice of at least 24 hours prior to conducting an inspection of the person's residence if that person is not required to register.

4.Prior to entry. The Department will show proof of identity when requesting entry to conduct an on-site assessment and to inspect an area reportedly used for conduct described under this rule and the statute. The Department will also provide the reason for the on-site assessment in standard written form developed by the Department prior to entry.

5.Precautions during on-site assessment. The Department will take measures to reduce potential disruption and contamination to the cultivation area during an on-site assessment.

6.Evidence. The Department may take samples, photographs or electronic copies during an on-site assessment to determine compliance.

7.Refusal of entry. If entry into an area reportedly used for conduct authorized by this rule and the statute is refused when the Department is conducting an on-site assessment, the Department will consider such action a failure to comply with provisions of this rule.

a. Upon refusal, the Department may refer to law enforcement as a progressive enforcement action when compliance cannot be determined.

b. Additionally, if denied entry by a cardholder, the Department may also take action to revoke the registry identification card or dispensary registration certificate.

8.On-site assessment report. An on-site assessment report will indicate whether any violation was identified and, if corrective action was taken, the outcome of that.

a.No action required. The Department will provide a report to the subject of the on-site assessment within 30 days of initiating the on-site assessment during which the Department did not identify a finding of non-compliance and no action was required.

b.Finding of non-compliance; enforcement action taken. The Department will provide a report within 30 days of initiating the on-site assessment during which the Department makes a finding of non-compliance, and may request a plan of correction.

c.Immediate enforcement action. The Department will document justification for any immediate enforcement action taken to suspend or revoke a registration certificate.

C.Allegations of non-compliance. The Department, upon receipt of a report alleging a participant's conduct is in violation of this rule or the statute, will record the allegation and may conduct an on-site assessment to ensure compliance.

1.Department response to allegations of non-compliance. Responses to reports alleging non-compliance are determined by the Department and may include the following: an on-site assessment which may include an interview, a paper review, and an inspection of premises; suspension or revocation of a registry identification card or certificate; and referral to the appropriate agency, department or entity when the allegation or reported conduct is not within the scope of the MMMP or has not been resolved through Department directed corrective action.

a.Documentation of report. The Department will document reported allegations of non-compliance that result in an on-site assessment. Documentation will include the following:

i. Date of the report of alleged violation;

ii. The identity of the subject of the report; and

iii. The related provision of rule or statute.

D.Plan of correction. If a plan of correction is requested by the Department, the plan must be sent within five business days of receipt of the notice of non-compliance. The Department will provide notice of approval or denial of the plan of correction within five business days of receipt. The Department may issue a directed plan of correction if the Department does not receive a timely, acceptable corrective action plan, or the plan is not completed satisfactorily. Failure to submit a timely plan of correction or to comply with the approved plan of correction may result in further enforcement action by the Department up to and including revocation and referral of criminal activity to law enforcement. An acceptable plan of correction must include the following:

1. Action steps to correct any finding, violation or deficiency noted by the Department in the notice of non-compliance;

2. Specific deadlines for each corrective action step; and

3. Steps to reduce potential future violation.

4. The Department is not obligated to remediate non-compliance with a corrective action plan and may take action for immediate registration revocation i or other enforcement action.

E.Progressive enforcement. The Department may take progressive enforcement action when the Department is unable to determine compliance when conducting an on-site assessment, or when a finding of non-compliance is not resolved through technical assistance provided on-site or through other remedial action. Progressive enforcement action may include fines or penalties, required plan of correction, registration denial or revocation, and referral to law enforcement.

F.Court ordered fines. The Department may seek a court order imposing fines in accordance with this rule and the statute.

G.Denial of application or renewal for a registry identification card. The Department may deny an application or renewal for a registry identification card for the reasons stated in 22 M.R.S. §2425(3). The effective date of denial of an application or request for renewal for a registry identification card is the date shown on the Department's written notice that is sent to the applicant's or cardholder's last known address. The notice issued by the Department will include the date of receipt of the application or request for renewal and reason for denial. When a request for renewal is denied, the registry identification card is void, unless timely appealed.

1. The Department may determine an applicant does not qualify for a registry identification card for reasons including, but not limited to, the following:

a. The applicant has failed to demonstrate compliance with this rule and the statute; and

b. The applicant is/will be using a location for conduct authorized by this rule and the statute where such conduct is prohibited by the host municipality's local codes and ordinances. Reapplication for a registry identification card.

2.Reapplication for a registry identification card. When an application or renewal has been denied, the person may reapply for a registry identification card after 30 days from the date of denial. The person must demonstrate compliance with this rule and the statute, including those provisions that were the basis for the denial, and submit a completed Caregiver Application or Employee/Board Member/Principal Officer Application, all required documentation and required fees.

H.Revocation of registry identification card. The Department may revoke a registry identification card. The effective date of revocation of a registry identification card is three days after the date shown on the Department's written notice that is sent to the cardholder's last known address. A revoked registry identification card is void unless timely appealed.

1.Revoked card: no dispensary employment or affiliation. A principal officer, board member or employee of a registered dispensary whose card has been revoked by the Department is disqualified from serving as a principal officer, board member or employee of a registered dispensary.

I.Grounds for revocation of registry identification card. Grounds for revocation of a registry identification card are governed by this rule and the statute and include, but are not limited to, the following:

1. The Department determines the cardholder is non-compliant with this rule or the statute, including failure to cooperate with on-site assessment or allow entry for inspection.

2. The cardholder is convicted of a disqualifying drug offense.

3. The cardholder knowingly violates the confidentiality of information protected by the statute.

4. The cardholder commits, permits, aids or abets any illegal practices or unauthorized conduct related to the cultivation, processing, acquisition, dispensing, delivering or transfer of marijuana.

5. The cardholder no longer lives in Maine and the card is not surrendered to the Department. For the purposes of these rules, "living in Maine" means having a physical home address in Maine and living, in the aggregate, more than 183 days of the calendar year in Maine.

6. The cardholder fails to pay required State and local taxes, in accordance with 36 M.R.S. §175.

7. A cardholder commits a civil violation for fraudulent misrepresentation regarding authorized conduct, possession of prepared marijuana in excess of specified limits or failure to provide required notifications to the Department.

8. A cardholder has repeat forfeiture of excess marijuana.

9. A cardholder has been issued finding of repeated non-compliance, has failed to comply with the plan of correction or is no longer eligible for a registry identification card.

J.Failure to surrender a void registry identification card. A void registry identification card that is not surrendered to the Department is inactive and no longer valid.

K.Grounds for voiding a registry identification card and authorized conduct. The registry identification card is voided by the Department when any of the following occurs:

1. A new card is issued to a dispensary cardholder based on a change in status, and the superseded card is not surrendered to the Department.

2. A person is no longer employed by or affiliated with a dispensary, a registered primary caregiver or facility including a hospice provider or nursing facility and the card is not surrendered to the Department.

3. A person within 12 months has confirmed positive results from two lawfully administered substance abuse tests and the card is not surrendered to the Department.

4. A patient's certifying medical provider notifies the Department in writing that the qualifying patient has ceased to suffer from a debilitating medical condition.

5. A request for registry identification card renewal is denied, and the card is not surrendered to the Department.

6. A revoked registry identification card is not surrendered to the Department.

L.Date card is void. The registry identification card is void ten days after the date shown on the Department's written notice that is sent to the last known address of the cardholder and the dispensary, if applicable.

M.Termination of dispensary registration certificate. The termination of a dispensary registration certificate is governed by this rule and the statute. The Department may seek a district court order terminating a dispensary registration certificate.

1. The date of the termination is the date designated in the court order or the date appeal rights are exhausted, whichever is later.

N.Grounds for termination of dispensary registration certificate. Grounds for termination of a dispensary registration certificate include the following:

1. Failure to cooperate with required inspections, including failure to allow entry or interference with entry;

2. Violations of this rule, the statute or dispensary policies and procedures that govern the operation of a dispensary;

3. Committing, permitting, aiding or abetting any illegal practices in the operation of the dispensary;

4. Conduct or practices that are detrimental to the safety and welfare of qualifying patients or primary caregivers.

5. Providing information that is materially inaccurate or incomplete; and

6. Failure to pay required State and local taxes.

O.Emergency suspension of dispensary registration certificate. The Department may suspend a dispensary registration certificate on an emergency basis when the Department determines that the conduct of the dispensary threatened or may pose an immediate threat to the health or safety of a person or the public. In accordance with 5 M.R.S. §§10004(3) and (4) such suspension may not exceed 30 days. A threat to public health and safety, includes but is not limited to, providing product containing an unsafe level of a contaminant or pesticide.

P.Final agency action. The Department's action pursuant to Section 10(G) or 10(H) is considered final agency action, as defined in 5 M.R.S. §8002(4), and subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court.

Q.Evidentiary record. The record for review is the Department's file for that person, cardholder or dispensary for the period in question, any other documents relied upon by the Department in taking the action, the Department's notice of the action, and other communications between the Department and the person, cardholder or dispensary regarding the action.

R.Notice and receipt of written notice. Prior to taking action under Section 10(G) or 10(H) the Department shall issue a written notice that includes the reason for the action, and the applicable rule or statute; the date the Department's action takes effect; and the right to appeal the Department's action. A person is deemed to have received written Department notification on the earliest of the following dates:

1. The date the person signs for receipt of the notice; or

2. The date that is three calendar days after the date the Department sends the notice by first class mail to the person's last known address.

18-691 C.M.R. ch. 2, § 10