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7. Identify the harm resulting from the behavior that the proposed rules are designed to alter and the likelihood
that the harm will occur in the absence of the rule.
The harm that will result is that marihuana product will not be produced, handled, or labeled consistently and will not
be produced to the current standards of good manufacturing practices. This could impact the health, safety, and
welfare of marihuana product consumers.
A. What is the rationale for changing the rules instead of leaving them as currently written?
The rationale for changing these rules it to create greater consistency in the production and labeling of marihuana
product and to ensure that handling and packaging standards are updated to current standards. This cannot be done
with the rules as currently written.
8. Describe how the proposed rules protect the health, safety, and welfare of Michigan citizens while promoting a
regulatory environment in Michigan that is the least burdensome alternative for those required to comply.
The proposed rules create consistent requirements for infused and edible marihuana product that will be available to
medical marihuana patients as well as adult-use consumers. They are structured to ensure that marihuana product that
is produced is done so according to good manufacturing practices, handled safely, and labeled appropriately for all
users.
9. Describe any rules in the affected rule set that are obsolete or unnecessary and can be rescinded.
These rules are replacing R333.261, R333.262, and Adult-Use Marihuana Establishments Emergency Rules 45 and
46.
10. Please provide the fiscal impact on the agency (an estimate of the cost of rule imposition or potential savings
for the agency promulgating the rule).
There will be no fiscal impact on the agency. The agency already manages both medical marihuana facilities
licensing and adult-use marihuana licensing.
11. Describe whether or not an agency appropriation has been made or a funding source provided for any
expenditures associated with the proposed rules.
No appropriations have been made to any governmental units because of these rules. No additional expenditures are
anticipated or intended with the proposed rules.
12. Describe how the proposed rules are necessary and suitable to accomplish their purpose, in relationship to the
burden(s) the rules place on individuals. Burdens may include fiscal or administrative burdens, or duplicative
acts.
The rules must ensure the safety, security, and integrity of the operation of marihuana businesses. Any burdens would
be in place as required by the MMFLA, MTA, and MRTMA. The application/licensing process requires
documentation, fingerprinting, etc. That will be at a financial and administrative cost. There are rules required for the
use of a statewide monitoring system which will place a burden on the individual but is statutorily required. These
items are already in place so there will be no increased burden.
A. Despite the identified burden(s), identify how the requirements in the rules are still needed and reasonable
compared to the burdens.
The rules must ensure the safety, security, and integrity of the operation of marihuana facilities. Any burden is
reasonable in the proposed rules as it complies with the statutory requirement for its consideration.
13. Estimate any increase or decrease in revenues to other state or local governmental units (i.e. cities, counties,
school districts) as a result of the rule. Estimate the cost increases or reductions for other state or local
governmental units (i.e. cities, counties, school districts) as a result of the rule. Include the cost of equipment,
supplies, labor, and increased administrative costs in both the initial imposition of the rule and any ongoing
monitoring.
There are no anticipated increases or decreases in revenues or costs to other state or local government units as a result
of the proposed rules. Any local or state change to revenue may occur via the statutory provisions as it concerns how
the funds, fees, or taxes are allocated or expended. The agency is required to set an application fee pursuant to the
MMFLA and MRTMA and has set the fee at $6,000 to offset the background investigations, administration of the
licensing application, etc. The other statutorily imposed fee is the annual regulatory assessment/renewal fee set forth
in the MMFLA and MRTMA which will be deposited in the marihuana regulatory fund.
14. Discuss any program, service, duty, or responsibility imposed upon any city, county, town, village, or school
district by the rules.
These rules do not impose any duties/responsibilities on cities, counties, towns, villages, or school districts, other
than the current duties to adopt ordinances to opt-in to allow medical marihuana facilities if they choose, or to opt out
of adult-use marihuana establishments if they choose.
MCL 24.245(3)