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He-C 402 Therapeutic Cannabis Program

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He-C 402 Therapeutic Cannabis Program RULEMAKING NOTICE FORM Notice Number 2014-140 Rule Number He-C 402 1. Agency Name & Address: 2. RSA Authority: RSA 126-X:6, III(a) 3. Federal Authority: NH Department of Health and Human Services Bureau of Licensing and Certification 4. Type of Action: Health Facility Licensing Unit Adoption X Therapeutic Cannabis Program Amendment 129 Pleasant Street Repeal Concord, NH 03301 Readoption Readoption w/amendment 5. Short Title: Therapeutic Cannabis Program – Alternative Treatment Centers 6. (a) Summary of what the rule says and of any proposed amendments: He-C 402 is a new rule which implements a portion of HB 573 from the 2013 legislative session (Chapter 232 of the Laws of 2013), relative to the use of cannabis for therapeutic purposes. The enabling law, RSA 126-X, creates an exemption in state law from criminal penalties for the therapeutic use of cannabis provided that its use is in compliance with RSA 126-X. The NH Legislature placed the responsibility for administering the program within the NH Department of Health and Human Services. He-C 402 sets forth the requirements necessary to establish, operate, and maintain an alternative treatment center (ATC) for the purposes of cultivating, processing, packaging, labeling, and dispensing therapeutic cannabis to qualifying patients or their designated caregivers. These requirements include the following: fees; registration application and renewal requirements; requirements for organizational of service changes; policy and procedure requirements; operational requirements; permitted quantities of cannabis; requirements for acquisition and transportation of cannabis; inventory control requirements; requirements for cultivation, processing, testing, storage, packaging and labeling, dispensing, and disposal of cannabis; requirements for the production of cannabis-infused products; sanitation requirements; educational requirements; advertising restrictions; security requirements; confidentiality requirements; requirements for inspections, plans of correction, and enforcement actions; personnel requirements; record keeping requirements; and requirements for fire safety and emergency preparedness. 6. (b) Brief description of the groups affected: Groups affected by this rule include operators of the ATCs and their agents as well as the qualifying patients and their designated caregivers who utilize the services of the ATCs to access therapeutic cannabis. Under RSA 126-X there must be at least two, but no more than four registered ATCs. 6. (c) Specific section or sections of state statute or federal statute or regulation which the rule is intended to implement: Rule Section RSA Implemented He-C 402.01 – 402.03 RSA 126-X He-C 402.04 RSA 126-X:6, III(a)(14); RSA 126-X:7, IV(a); RSA 126-X:7, V He-C 402.05 RSA 126-X:7, IV(a); RSA 126-X:7, IX He-C 402.06 RSA 126-X:6, III(a)(1); RSA 126-X:7, V; RSA 126-X:7, IX He-C 402.07 RSA 126-X:6, III(a)(2) He-C 402.08 RSA 126-X:3 He-C 402.09 RSA 126-X:6, III(a)(2) He-C 402.10 RSA 126-X:6, III(a)(2) He-C 402.11 RSA 126-X:2, IX(a)-(b); RSA 126-X:8, XV(b); RSA 126-X:8, XIV He-C 402.12 RSA 126-X:8, XV(a) He-C 402.13 RSA 126-X:8, VIII He-C 402.14 RSA 126-X:7, IV(a)(8); RSA 126-X:8, X, XV(c) He-C 402.15 RSA 126-X:6, III(a)(5); RSA 126-X:7, IV(a)(9), IV(c)(5) He-C 402.16 RSA 126-X:1, III, XV He-C 402.17 RSA 126-X:6, III(a)(5), III(b) He-C 402.18 RSA 126-X:6, III(a)(5) He-C 402.19 RSA 126-X:6, III(a)(9); RSA 126-X8, XIV(b); RSA 126-X:8, XVI(a) He-C 402.20 RSA 126-X:8, VII(b); RSA 126-X:8, XIII He-C 402.21 RSA 126-X:8, XVI(b)-(c) He-C 402.22 RSA 126-X:8, VII(a) He-C 402.23 RSA 126-X:6, III(a)(12) He-C 402.24 RSA 126-X:6, III(a)(3); RSA 126-X:7, IV(a)(5), (c)(7); RSA 126-X:8, III He-C 402.25 RSA 126-X:6, III(b); RSA 126-X:7, IV(c)(6), IX; RSA 126-X:8, XVI(b) He-C 402.26 RSA 541-A:22, IV He-C 402.27 RSA 126-X:6, III(a)(2), (a)(11) He-C 402.28 RSA 126-X:6, III(a)(iii); RSA 126-X:7, IX He-C 402.29 RSA 126-X:6, III(a)(2) He-C 402.30 RSA 126-X:6, III(a)(2), (a)(10); RSA 126-X:7, VII-VIII He-C 402.31 RSA 126-X:6, III(a)(8); RSA 126-X:8, IV, V, XVII He-C 402.32 RSA 126-X:7, IV(a)(13), IX; RSA 126-X:8, VI-VII; RSA 126-X:8, XVII(c) He-C 402.33 RSA 126-X:6, III(a)(2), (a)(6) 7. Contact person for copies and questions including requests to accommodate persons with disabilities: Name: Michael Holt Title: Rules Coordinator Address: Dept. of Health and Human Services Phone #: 271-9234 Administrative Rules Unit 271-5590 129 Pleasant St. Fax#: Concord, NH 03301 E-mail: [email protected] TTY/TDD Access: Relay NH 1-800-735-2964 or dial 711 (in NH) The proposed rules may be viewed and downloaded at: http://www.dhhs.nh.gov/oos/aru/comment.htm and http://www.dhhs.nh.gov/oos/tcp/index.htm 8. Deadline for submission of materials in writing or, if practicable for the agency, in the electronic format specified: Thursday, October 23, 2014 Fax E-mail Other format (specify): 9. Public hearing scheduled for: Date and Time: Thursday, October 16, 2014 at 2:00 PM Place: DHHS Brown Bldg., Auditorium, 129 Pleasant St., Concord, NH 10. Fiscal Impact Statement (Prepared by Legislative Budget Assistant) FIS # 14:143 , dated 09/17/14 1. Comparison of the costs of the proposed rule(s) to the existing rule(s): Not applicable, these are new rules. 2. Cite the Federal mandate. Identify the impact of state funds: No federal mandate, no impact on state funds. 3. Cost and benefits of the proposed rule(s): The proposed rules implement a portion of Chapter 242, Laws of 2013 (HB 573) relative to the use of cannabis for therapeutic purposes. The enabling law, RSA 126-X, creates an exemption in state law from criminal penalties for the therapeutic use of cannabis provided that its use is in compliance with said statute. The responsibility for administering the program is within the NH Department of Health and Human Services. A. To State general or State special funds: The proposed rules set forth the requirements necessary to establish, operate, and maintain an alternative treatment center (ATC) for the purposes of cultivating, processing, packaging, labeling, and dispensing therapeutic cannabis to qualifying patients or their designated caregivers. These requirements include the following: fees; registration application and renewal requirements; requirements for organizational of service changes; policy and procedure requirements; operational requirements; permitted quantities of cannabis; requirements for acquisition and transportation of cannabis; inventory control requirements; requirements for cultivation, processing, testing, storage, packaging and labeling, dispensing, and disposal of cannabis; requirements for the production of cannabis-infused products; sanitation requirements; educational requirements; advertising restrictions; security requirements; confidentiality requirements; requirements for inspections, plans of correction, and enforcement actions; personnel requirements; record keeping requirements; and requirements for fire safety and emergency preparedness. RSA 126-X:11 establishes the Registry Identification Card and Certificate Fund to pay for the operational expenses of the Therapeutic Cannabis Program. The proposed rules contain various fees and fines which will be deposited into the fund to offset costs of the program. While the statute requires that fees be imposed, it is the rule that sets the exact amount of the fees, which include: Request for proposal (RFP) submission fee - $1,500; Initial registration fee - $80,000; Annual renewal fee - $80,000; Change in name - $250; Change in administrator - $250; Compliance monitoring to verify the implementation of a plan of correction - $1,000; Inspection fee following new construction or renovations for the ATC - $1,200; and Change in ownership, or a change in location - fees for a new registration shall apply. The proposed rules also establish a schedule of fines that can be imposed against ATCs if they failed to comply with the provisions of the statute or rule. Any fines paid to the Department would also be deposited into the Registry Identification Care and Certificate Fund. The exact fiscal impact cannot be determined at this time. There will be no cost or benefit to the State general fund. B. To State citizens and political subdivisions: None. C. To Independently owned businesses: Alternative Treatments Centers (ATC’s) will incur costs related to: fees, liability insurance requirements, packaging and labeling requirements, required educational materials, minimum security requirements, and operating policies and standards including the cost testing of each batch cultivated and annual soil tests. The ATC’s will also experience costs relating to the recordkeeping and reporting requirements. In addition, an ATC could be subject to fines for failure to comply with provisions of the statute or rules. The exact fiscal impact is indeterminable at this time. See A above. The proposed rules require each batch of cannabis harvested by the ATC be tested for its cannabinoid profile. In addition, soil used to cultivate cannabis must be tested annually. This will result in an indeterminable cost to ATCs as stated above, but will also result in an indeterminable benefit to laboratories that conduct the testing, that will vary based upon such factors as the number of batches harvested by the ATC and the cost of testing imposed by the laboratory conducting the testing.
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