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Natural Medicine Division

Rulemaking Work Group

Cultivation Requirements

1

Dominique Mendiola, Allison Robinette, Kyle Lambert, and Amelia Myers�Department of Revenue Natural Medicine Division

June 12, 2024

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2

NMD identifies areas that cannot be addressed through rulemaking

NMD compiles the rule record

We are here

Permanent Rulemaking Hearing - July 25, 2024

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Agenda

June 12, 2024

  1. Welcome & Introductions
  2. Rules Presentation - Cultivation Requirements
    • Part 5 (Rules 5005 - 5020)

Public Comment on Cultivation Requirements

  • Lunch Break (11:30 - 1:00)
  • Rules Presentation - Manufacturing Requirements
    • Part 6 (Rules 6005 - 6015)
  • Next Steps

3

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Prop 122 to SB 23-290

​

Signed May 23, 2023

  • Natural Medicine Defined
    • Psilocybin & Psilocin (Initially)
    • Ibogaine (Prior to 2026)
    • DMT, Mescaline (2026)
  • Primary Code Changes
    • Title 12
    • Title 25
    • Title 44
    • Titles 16 & 18

4

  • Outline of Provisions
    • DORA Regulatory Program
    • DOR Regulatory Program
    • CDPHE Regulatory Role
    • Personal Use Provisions
  • Implementation Timeline Extended
    • Extended Timeline for Rulemaking & Applications

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Engagement & Expectations

5

  • Meeting Materials - Available on the NMD Website
  • Comment Opportunities
    • Please sign-up to provide comments during the meeting, using the online sign in sheet
    • Oral comments during rulemaking meeting will be limited to 3 minutes each
    • Written public comment form is always available
  • Business promotion is not appropriate
  • Please be respectful

6 of 23

NMD Rulemaking Guiding Principles

Rules should be:

6

TRANSPARENT

SYSTEMATIC

OPERABLE

DEFENSIBLE

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Proposed Rules Presentation

Cultivation Requirements

Rules 5005 - 5025

Pages 4 - 11

7

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Public Comments

8

Each speaker has 3 minutes.

We will take comments in the order folks sign-up on the comment form.

9 of 23

Wrap Up & Next Steps

9

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DOR Rulemaking Schedule

10

  1. March 20, 2024: Licensing & Application Requirements & Procedures
  2. April 10, 2024: General Requirements
  3. May 1, 2024: Healing Center Requirements
  4. May 31, 2024: Advertising, Packaging & Labeling Requirements
  5. June 12, 2024: Cultivation & Manufacturing Requirements
  6. June 25, 2024: Testing Requirements & Testing Facilities
  7. July 9, 2024: Cultivation, Manufacturing, Testing, and Inventory Tracking; Enforcement, Discipline, and “Catch-All”

Permanent Rulemaking Hearing - July 25, 2024

11 of 23

CDPHE Rulemaking Updates

11

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Natural Medicine Division

Rulemaking Work Group

Manufacturing Requirements

12

Dominique Mendiola, Allison Robinette, Kyle Lambert, and Amelia Myers�Department of Revenue Natural Medicine Division

June 12, 2024

13 of 23

13

NMD identifies areas that cannot be addressed through rulemaking

NMD compiles the rule record

We are here

Permanent Rulemaking Hearing - July 25, 2024

14 of 23

Agenda

June 12, 2024

  • Welcome & Introductions
  • Rules Presentation - Manufacturing Requirements
    • Part 6 (Rules 6005 - 6015)

Public Comment on Manufacturing Requirements

  • Next Steps

14

15 of 23

Prop 122 to SB 23-290

​

Signed May 23, 2023

  • Natural Medicine Defined
    • Psilocybin & Psilocin (Initially)
    • Ibogaine (Prior to 2026)
    • DMT, Mescaline (2026)
  • Primary Code Changes
    • Title 12
    • Title 25
    • Title 44
    • Titles 16 & 18

15

  • Outline of Provisions
    • DORA Regulatory Program
    • DOR Regulatory Program
    • CDPHE Regulatory Role
    • Personal Use Provisions
  • Implementation Timeline Extended
    • Extended Timeline for Rulemaking & Applications

16 of 23

Engagement & Expectations

16

  • Meeting Materials - Available on the NMD Website
  • Comment Opportunities
    • Please sign-up to provide comments during the meeting, using the online sign in sheet
    • Oral comments during rulemaking meeting will be limited to 3 minutes each
    • Written public comment form is always available
  • Business promotion is not appropriate
  • Please be respectful

17 of 23

NMD Rulemaking Guiding Principles

Rules should be:

17

TRANSPARENT

SYSTEMATIC

OPERABLE

DEFENSIBLE

18 of 23

Proposed Rules Presentation

Manufacturing Requirements

Rules 6005 - 6015

Pages 11 - 16

18

19 of 23

Public Comments

19

Each speaker has 3 minutes.

We will take comments in the order folks sign-up on the comment form.

20 of 23

Wrap Up & Next Steps

20

21 of 23

DOR Rulemaking Schedule

21

  • March 20, 2024: Licensing & Application Requirements & Procedures
  • April 10, 2024: General Requirements
  • May 1, 2024: Healing Center Requirements
  • May 31, 2024: Advertising, Packaging & Labeling Requirements
  • June 12, 2024: Cultivation & Manufacturing Requirements
  • June 25, 2024: Testing Requirements & Testing Facilities
  • July 9, 2024: Cultivation, Manufacturing, Testing, and Inventory Tracking;

Enforcement, Discipline, and “Catch-All”

​

Permanent Rulemaking Hearing - July 25, 2024

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CDPHE Rulemaking Updates

22

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Resources Shared During the Meeting

23