DHSS amends emergency rules in newly released proposed rules
Thirty comments were submitted and taken into consideration on the Department of Health and Senior Services Medical Marijuana Division rulemaking emergency rules filed earlier in 2019.
Most of the comments resulted in rule amendments or tweaks, but many sections had no comments reflected in the December 2 Missouri Register. These amendments were to the July 1 emergency rules and set up the rules as new proposed rules, effective in 30 days.
“A notice of proposed rulemaking containing the text of the proposed rule was published in the Missouri Register on July 1, 2019 (44 MoReg 1933-1935). Those sections with changes are reprinted here. This proposed rule becomes effective thirty (30) days after publication in the Code of State Regulations.”
MoCannTrade, one of several trade groups in the state, successfully presented rulemaking changes: one of which regards the language of facility location changes and the other regarding a tweak to the packaging rule. Many of the comments were not attributed.
Joseph “Chip” Sheppard of Carnahan, Evans, Cantwell & Brown P.C, and also a member of the MoCannTrade board, advised the Department to change language regarding facility re-location, noting that MoCannTrade does not have an official position on the topic, but many members believe the rule – as previously written – provides “too high a hurdle,” in 19 CSR 30- 95.040(4)(C)3.D.
“DHSS appreciates the thoughtfulness and thoroughness of this comment and agrees with many of the proposed standards for approving a change of location application,” reads the Department’s response and change explanation. “However, DHSS has not included such specificity in any of the other types of change approvals. This was an intentional policy decision in order to leave as much flexibility as possible for applicants to present and for DHSS to grant such applications. Also, DHSS is not convinced each standard in the suggested language would qualify as showing whether it is feasible to operate at an existing location, and some standards may make such a showing in one circumstance but not in others. Finally, the suggested language regarding a list of specific standards is not an exhaustive list and, as such, does not provide any more benefit to applicants or DHSS than would leaving the reasoning and approval up to the discretion of applicants and DHSS.”
“No longer possible,” has been removed to an alternative proposed by Sheppard to read, “an explanation for why the facility’s original location is currently unduly burdensome for the licensee.”
Regarding packaging, the trade association denoted:
“If possible, we would recommend considering a rule change during the feedback period to allow for the following before operators commit to packaging and labeling purchases after licenses are issued: “Marijuana and marijuana-infused products shall be sold in containers clearly and conspicuously labeled, in a font no smaller than 7 point type…” reads a comment from Cassie Grewing on behalf of MoCannTrade.
“[T]he department cannot make the suggested change to the part of the rule that repeats this requirement verbatim,” explains the response to the comment. “However, the department can make the suggested change to the part of the rule regarding font size of the warning language and will do so. The rule is amended to reflect a change as described here.”
“Missouri has avoided many of the pitfalls, delays and confusion that other states have experienced when trying to implement a medical marijuana program,” Andrew Mullins, executive director of MoCannTrade, said. “DHSS deserves credit for once again engaging stakeholders and taking public input to make changes and improvements to Missouri’s medical marijuana rules and regulations. MoCannTrade continues to be an active participant in this process so that we can provide a strong, unifying voice for the industry in Missouri, with the ultimate outcome of having rules that are fair and sensible.”
Another notable rule amendment was to the Department’s 48-hour license acceptance rule, which was proposed as an emergency rule recently.
“DHSS finds the suggested language addresses administrative efficiency and also the purpose of the Article XIV,” reads the response and explanation of change. “Administrative efficiency is served by allowing a potential licensee to choose not to accept a license so that the license may be offered to another entity from the same application round instead of opening an entirely new application round to fill that license. This also serves the apparent intent of Article XIV that a certain minimum number of licenses be actually issued. The rule is amended as suggested. “
Rulemaking authority is vested in the Division of Regulation and Licensure under Art. XIV in the Missouri Constitution.
RULE CHANGES SUMMARY OF COMMENTS
Title 19—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure Chapter 95—Medical Marijuana
SUMMARY OF COMMENTS: The Department of Health and Senior Services received two (2) comments on the proposed rule, both from the DHSS Section for Medical Marijuana Regulation.
COMMENT #1: The rule should include a definition for “employment rate.” Suggested language: “Employment rate” means the percent of the civilian labor force that is employed.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rule in that the term “employment rate” is not defined, and applying the proposed definition to the term, where applicable, results in the effect intended by the proposed rule. The rule is amended as suggested.
COMMENT #2: The definition for “seed-to-sale tracking system” in .010(36) should be modified to match the way that term is used throughout Chapter 95. Specifically, the definition should not include the statewide track and track system
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rule. The use of the term “seed-to-sale tracking system” throughout the applicable rules does not apply to the statewide track and trace system. The rule is amended as suggested.
SUMMARY OF COMMENTS: The Department of Health and Senior Services received ten (10) comments on the proposed rule, all from the DHSS Section for Medical Marijuana Regulation.
COMMENT #1: 19 CSR 30-95.025(4)(A)3. contains a typo in the included citation. The correct citation is 19 CSR 30-95.040(3)(C)- (D).
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the comment is accurate. The rule is amended as suggested.
COMMENT #2: 19 CSR 30-95.025(4)(A)5. should be clarified by replacing the current language with the following: That the entity can comply with any local government zoning laws specific to the entity’s type of facility other than applicable local government requirements regarding proximity to schools, daycares, or churches.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rules. Zoning laws regarding proximity to schools, daycares, or churches are already requested elsewhere in this section. The intent of 19 CSR 30-95.025(4)(A)5. was not to ask for the same information again but rather for any other applicable zoning regulations, and the suggested language makes that clear. The rule is amended as suggested.
COMMENT #3: 19 CSR 30-95.025(4)(C)2.B. should be clarified. Where “must” appears, the more appropriate word to use is “should.” Further, the existing language about obscuring certain information is confusing and should be replaced with specific instructions about what information should be redacted.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested changes clarify the proposed rule. The suggested changes better reflect the intent of the proposed rule and also match the guidance issued by the department during the facility application process regarding the department’s interpretation. The rule is amended as suggested.
COMMENT #4: 19 CSR 30-95.025(4)(C)6. should be clarified to acknowledge this step comes after when facilities have been both ranked and scored.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rule. The rule is amended as suggested.
COMMENT #5: 19 CSR 30-95.025(4)(C)8. contains a typo. The correct paragraph number to cite is paragraph 6. not 7.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the comment is accurate. The rule is amended as suggested.
COMMENT #6: 19 CSR 30-95.025(4)(D) should be modified to allow for filling license/certification openings that occur during the issuance process. This can be accomplished by adding a new provision after 19 CSR 30-95.025(4)(D)2., which should say “All facilities that are issued a license or certification will be given forty-eight (48) hours to confirm they accept the license or certification. If a facility does not accept issuance of a license or certification, the license or certification will be offered to the next ranked facility, as applicable, until all available licenses and certifications are issued and accepted.”
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language addresses administrative efficiency and also the purpose of the Article XIV. Administrative efficiency is served by allowing a potential licensee to choose not to accept a license so that the license may be offered to another entity from the same application round instead of opening an entirely new application round to fill that license. This also serves the apparent intent of Article XIV that a certain minimum number of licenses be actually issued. The rule is amended as suggested.
COMMENT #7: 19 CSR 30-95.025(5)(A) should be clarified to ensure understanding that the legal limit referenced is the possessor’s legal limit.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rule. The rule is amended as suggested.
COMMENT #8: 19 CSR 30-95.025(5)(C)2. contains a typo. The citation should be to 19 CSR 30-95.040(1)(F)7., not 19 CSR 30- 95.040(1)(E)7.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the comment is accurate. The rule is amended as suggested.
COMMENT #9: 19 CSR 30-95.025(5)(C)1. should be modified to include a one thousand dollar penalty, not a two hundred dollar penalty.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language establishes a penalty more appropriate to the seriousness of the action. The rule is amended as suggested.
COMMENT #10: 19 CSR 30-95.025(7)(A) should be clarified. The services referenced should be seed-to-sale tracking services, not seed-to-sale services.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rule and also makes it consistent with the related rule. The rule is amended as suggested.
SUMMARY OF COMMENTS: The Department of Health and Senior Services received four (4) comments on the proposed rule, all from the DHSS Section for Medical Marijuana Regulation.
COMMENT #1: 19 CSR 30-95.030(3)(D)2. should be clarified as follows: … However, the later authorization to cultivate will be added to the qualifying patient or primary caregiver identification card and will only remain valid as long as the qualifying patient or primary caregiver’s identification card is still valid. The cultivation application fee will be the same for all cultivation applications no matter how much time remains on the validity of the patient or caregiver’s identification card. The cultivation authorization must be renewed at the time the patient or caregiver identification card is renewed.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rule. The existing rule already dictates that the cultivation authorization would run concurrently with the patient/caregiver authorization but did not address how the fee would be applied. It also did not specifically address the timing of renewals for cultivation authority that was added to an existing patient/caregiver authority. The rule is amended as suggested.
COMMENT #2: 19 CSR 30-95.030(4) should include a new provision stating: Non-emancipated qualifying patients are not eligible for patient cultivation authorization.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language complies with Section 1.7.(13) of Article XIV of the Missouri Constitution, which says, “Only the Qualifying Patient’s parent or guardian shall purchase or possess medical marijuana for a non-emancipated Qualifying Patient under the age of eighteen.” The rule is amended as suggested.
COMMENT #3: 19 CSR 30-95.030(4) should include a new provision stating: Only one individual in a patient-caregiver relationship may be authorized for patient cultivation.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language complies with Section 1.3.(2)(12) of Article XIV of the Missouri Constitution, which says, “a Qualifying Patient or his or her Primary caregiver may obtain an identification card from the department to cultivate up to six flowering marijuana plants for the exclusive use of that Qualifying Patient” (emphasis added). The rule is amended as suggested.
COMMENT #4: 19 CSR 30-95.030(8)(D) should be modified as follows: If medical marijuana in possession of a primary caregiver is stolen or lost, the primary caregiver must notify the department within two (2) days.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rule. There is no department-approve format for this type of communication. The rule is amended as suggested.
SUMMARY OF COMMENTS: The Department of Health and Senior Services received nine (9) comments on the proposed rule. Seven (7) comments were from the DHSS Section for Medical Marijuana Regulation, one was from Joseph D. Sheppard III, and one (1) was from Cassie Grewing.
COMMENT #1: DHSS states 19 CSR 30-95.040(1)(E) should be clarified to include the qualification that affiliates of the entity that currently holds a contract with the state are also subject to the prohibition.
RESPONSE: The suggested language is already included in the proposed rule. No change has been made to the proposed rule in response to this comment.
COMMENT #2: DHSS states 19 CSR 30-95.040(3)(E)6. should be modified to required that facility agents have a government-issued photo ID with them at all times in addition to their facility agent ID cards.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language is reasonable. A government-issued photo ID card must be produced along with a facility agent ID card in order to verify the identity of the card holder. The rule is amended as suggested.
COMMENT #3: DHSS states 19 CSR 30-95.040(3)(E)7. should be clarified to ensure understanding that the fee for facility agent ID cards is an administration and processing fee and should increase or decrease with the Consumer Price Index.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the nature of this fee and matches the adjustment mechanism used for other, similar fees established by Article XIV. The rule is amended as suggested.
COMMENT #4: Joseph Sheppard of Carnahan, Evans, Cantwell & Brown, P.C. states that in subparagraph 19 CSR 30- 95.040(4)(C)3.D., the regulation requires the Department of Health’s approval before any change in location of any licensed facility and only allows that approval if it is “no longer possible” to operate at the current location. There is no definition of what “no longer possible” or any provision that describes the circumstances. While MOCANNTRADE does not have an official position on this topic, several believe that this is too high a hurdle. Even with a market study and an economic impact study, the largest corporations in the country or in the world will still locate businesses in places that, for whatever reason, prove to be impractical or not optimal. Suggested change: “Location may be changed with the consent of the Department of Health which shall balance the needs of the patients with the need of the licensee to maintain financial stability including factors such as (a) availability of medicine for the patient base in that geographical area; (b) adequacy of competition in the area; (c) safety and security of the patients and staff; (d) lack of demand in the community; (e) lack of supply (in the case of dispensaries) in another part of the state or congressional district; (f) conditions that make the licensee’s current location unable to compete in the marketplace, among other factors, if material, to the decision. In addition, the location change request shall include support that claims made in the facility’s initial licensure application regarding benefits the original location also apply to the facility’s newly proposed location or a reasonable basis for a location change despite one or more of those benefits not applying to the new location.” Example: An area that once looked promising, due to changing demographics has caused significant challenges to maintain a sufficient patient base or a sufficient staffing level or both. Alternative suggested change: Removal of the phrase ‘no longer possible’ such that D. would read ‘an explanation for why the facility’s original location is currently unduly burdensome for the licensee.’
RESPONSE AND EXPLANATION OF CHANGE: DHSS appreciates the thoughtfulness and thoroughness of this comment and agrees with many of the proposed standards for approving a change of location application. However, DHSS has not included such specificity in any of the other types of change approvals. This was an intentional policy decision in order to leave as much flexibility as possible for applicants to present and for DHSS to grant such applications. Also, DHSS is not convinced each standard in the suggested language would qualify as showing whether it is feasible to operate at an existing location, and some standards may make such a showing in one circumstance but not in others. Finally, the suggested language regarding a list of specific standards is not an exhaustive list and, as such, does not provide any more benefit to applicants or DHSS than would leaving the reasoning and approval up to the discretion of applicants and DHSS. However, DHSS does find the alternative suggestion is reasonable as a way to express a general standard without creating as high a bar for these approval requests. The rule is amended to reflect the alternative suggestion.
COMMENT #5: DHSS states 19 CSR 30-95.040(4)(C) should include a new provision to establish a fee for the extra approval processes facilities may seek for certain changes to their businesses. The new provision should say, “All requests for department approval described in this subsection must be accompanied by an administration and processing fee, due at the time of the request. This fee shall be two thousand dollars ($2000) on the effective date of this rule but shall increase or decrease each year by the percentage of increase or decrease from the end of the previous calendar year of the Consumer Price Index, or successor index as published by the U.S. Department of Labor, or its successor agency. The department shall publish the current fees, including any adjustments, on its website at http://medicalmarijuana.mo.gov.”
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language is reasonable. The department approvals referenced in this new provision will require review and processing of requests that include much of the same volume and complexity as initial applications for licensure/certification. It is reasonable that an administration and processing fee should be associated with application for these department approvals. Furthermore, the amount of the fee is reasonable in that it is much less than the initial application fee, for comparatively similar review other than the cost of scoring an application. The rule is amended as suggested.
COMMENT #6: Cassie Grewing, on behalf of MOCANN Trade, states 19 CSR 30-95.040(4)(K)2.A.-B. reads (beginning in middle of pg. 1815): (K) All cultivation, infused products manufacturing, and dispensary shall ensure that all medical marijuana is packaged and labeled in a manner consistent with the following: 1. Facilities shall not manufacture, package, or label marijuana— A. In a false or misleading manner; B. In any manner designed to cause confusion between a marijuana product and any product not containing marijuana; or C. In any manner designed to appeal to a minor; 2. Marijuana and marijuana-infused products shall be sold in containers clearly and conspicuously labeled, in a font size at least as large as the largest other font size used on the package, with: A. “Marijuana” or a “Marijuana-infused Product”; and B. “Warning: Cognitive and physical impairment may result from the use of Marijuana”; See attached V3: If possible, we would recommend considering a rule change during the feedback period to allow for the following before operators commit to packaging and labeling purchases after licenses are issued: “Marijuana and marijuana-infused products shall be sold in containers clearly and conspicuously labeled, in a font no smaller than 7 point type, with:”
RESPONSE AND EXPLANATION OF CHANGE: DHSS understands the concern. Unfortunately, part of the suggested language would be contrary to a provision of Article XIV of the Missouri Constitution, which says, “All marijuana and marijuana-infused products shall be sold in containers clearly and conspicuously labeled, in a font size at least as large as the largest other font size used on the package, as containing ‘Marijuana,’ or a ‘Marijuanainfused Product.’ Therefore, the department cannot make the suggested change to the part of the rule that repeats this requirement verbatim. However, the department can make the suggested change to the part of the rule regarding font size of the warning language and will do so. The rule is amended to reflect a change as described here.
COMMENT #7: DHSS states 19 CSR 30-95.040(5) should include a new provision following 19 CSR 30-95.040(5)(A)2., which should say, “The department may also request to interview an owner, officer, manager, contractor, employee, or other support staff of a licenses or certified facility, and the facility shall arrange for the interview to occur as soon as possible but not later than five (5) days after the department makes the request.”
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language is reasonable. The department authority for inspection should extend to discussing facility operations, etc., with the individuals performing, supervising, and directing those operations, and it should be the regulated entity’s responsibility to facilitate that. The rule is amended as suggested.
COMMENT #8: DHSS states 19 CSR 30-95.040(5)(D) is duplicative of 19 CSR 30-95.025(3) and should be deleted.
RESPONSE AND EXPLANATION OF CHANGE: DHSS agrees. The rule is amended as suggested.
COMMENT #9: DHSS states the 19 CSR 30-95.040 authority section should cite to RSMo, 195.820.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggestion is reasonable. The newly passed section 195.820, RSMo is generally applicable to fees currently established by Article XIV and clarifies the department’s authority for administrative fees that are not specifically established by Article XIV. The rule is amended as suggested.
A notice of proposed rulemaking containing the text of the proposed rule was published in the Missouri Register on July 1, 2019 (44 MoReg 1926-1930). Those sections with changes are reprinted here. This proposed rule becomes effective thirty (30) days after publication in the Code of State Regulations.
SUMMARY OF COMMENTS: The Department of Health and Senior Services received three (3) comments on the proposed rule, all from the DHSS Section for Medical Marijuana Regulation.
COMMENT #1: 19 CSR 30-95.090(3)(A) contains a typo. The citation referenced should be 19 CSR 30-95.080(2)(C), not 19 CSR 30- 95.080(2)(D).
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the comment is accurate. The rule is amended as suggested.
COMMENT #2: 19 CSR 30-95.090(4)(A) should be rephrased as a prohibition since it appears in a section of prohibitions.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rule. The rule is amended as suggested.
COMMENT #3: 19 CSR 30-95.090(4)(B) should be clarified to include the qualification that affiliates of the entity that currently holds a contract with the state are also subject to the prohibition.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language is appropriate. The word “currently” makes the provision ambiguous since it is not clear what time period should be considered current. The rule is amended as suggested.
A notice of proposed rulemaking containing the text of the proposed rule was published in the Missouri Register on July 1, 2019 (44 MoReg 1931-1932). Those sections with changes are reprinted here. This proposed rule becomes effective thirty (30) days after publication in the Code of State Regulations.
SUMMARY OF COMMENTS: The Department of Health and Senior Services received two (2) comments on the proposed rule, both from the DHSS Section for Medical Marijuana Regulation.
COMMENT #1: 19 CSR 30-95.100(2)(B) should be clarified to say that all transportation of medical marijuana should occur between an originating facility and a destination, not a destination facility, within twenty-four (24) hours.
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested language clarifies the proposed rule. Transportation facilities can transport to more locations than just other facilities. The rule is amended as suggested.
COMMENT #2: 19 CSR 30-95.100(2)(C) should be replaced with the location requirements applicable to all other facility types, which can be found at 19 CSR 30-95.040(4)(B).
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggested change is appropriate. All medical marijuana facilities should be held to the same standard on this constitutional requirement. The rule is amended as suggested.
SUMMARY OF COMMENTS: The Department of Health and Senior Services received one (1) comment on the proposed rule from the DHSS Section for Medical Marijuana Regulation.
COMMENT #1: 19 CSR 30-95.110 should include a new provision, which should say, “The department may request to interview any physician who chooses to certify individuals as qualifying patients. If such a request is made, the physician shall arrange for the interview to occur as soon as possible but not later than thirty (30) days after the department makes the request.”
RESPONSE AND EXPLANATION OF CHANGE: DHSS finds the suggestion is reasonable. The department’s oversight of patient applications for authorization to access medical marijuana should extend to interviewing the physician that certified a patient, which is the foundation for the patient’s application. For example: If there is reason to believe a patient has modified a physician’s certification, DHSS should have the ability to interview the physician to verify whether the certification remains as the physician entered it. Furthermore, the suggested language serves the interest of transparency in that it gives physicians notice of DHSS’ expectation that such conversations may be necessary. The rule is amended as suggested.
FEATURED PHOTO/CHRIS SMITH