From:  
To:  
Hendricks, Robert  
MRA-Legal  
Cc:  
Johnson, Matthew; Martin, Rodney; Hendricks, Robert; Sheets, Kaitlin; Nimphie, Benjamin; Hajali, Mazen;  
Chitwood, Alexandra  
Subject:  
Date:  
Comments on proposed rule revisions  
Monday, September 27, 2021 3:28:05 PM  
Attachments:  
image001.jpg  
22355973_1 Proposed MRA Rule Comments (Combined)-c.DOCX  
CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov  
Marijuana Regulatory Agency  
Legal Section  
P.O. Box 30205  
Lansing, MI 48909  
Attached please find our comments on the proposed revised rules.  
Thank you for your attention and assistance.  
Respectfully yours,  
Robert A. Hendricks | Senior Counsel  
Warner Norcross + Judd LLP  
1500 Warner Building, 150 Ottawa Ave., NW, Grand Rapids, MI 49503  
d 616.752.2291 | m 616.302.3480 | rhendricks@wnj.com  
This email and any attachments are solely for the confidential use of the intended recipient. If you are not the  
intended recipient, please do not read, distribute or act in reliance on it or any attachments. If you received this  
email by mistake, please notify us immediately by email, and promptly delete this email and any attachments.  
The attorney-client and work product privileges are not waived by the transmission of this email.  
Rule Citation  
Rule Title  
Page  
Comments  
Number  
MARIHUANA LICENSES  
R 420.1(1)(o)  
Definitions  
3
Rule adds definition of “Limited access area” meaning a “building, room, or other contiguous area of a  
marihuana business where marihuana is grown, cultivated, stored, weighed, packaged, sold or processed for sale  
and that is under the control of the licensee.”  
This definition will add greater clarity of limited access areas for licensees. However, what if the licensee has  
multiple licenses operating at the same location and has a limited access area under the licensee’s control, but is  
not contiguous to the marijuana business?  
R 420.1(1)(dd)  
R 420.3(3)  
Definitions  
4
5
Rule adds definition of a “Restricted access area” meaning a designated and secure area at a marihuana business  
where marihuana products are sold, possessed for sale, and displayed for sale.  
The definitions do not define “secure area.” I assume this definition adheres to the security requirements in R  
420.209, but I would like to see more specific language here, e.g., “secured by four walls and a locking door.”  
Rule states that partial applications to obtain prequalification status may be administratively withdrawn if  
application was filed and has been pending for more than 1 year. After a partial application has been withdrawn,  
the applicant may be required to submit a new application and pay a new nonrefundable application fee.  
Application  
procedure;  
requirements  
If an application has been partially completed and the application fee paid prior to withdrawal, it seems excessive  
to make the applicant pay another application fee when they resubmit.  
R 420.3(4)  
Application  
requirements;  
financial and  
criminal  
5
Rule states that “an applicant who has been granted prequalification status may have that status revoked by the  
agency and a marihuana license denied should the agency determine that the applicant is no longer suitable or no  
longer qualifies for licensure under the acts and these rules. An applicant who has had its prequalification status  
revoked may request a hearing pursuant to R 420.703.”  
background  
This rule concerns me. It gives the MRA complete discretion to revoke prequalification status if “the applicant  
is no longer suitable.” That is a very vague definition.  
R 420.5(1)(d)(vii)  
Application  
requirements;  
complete  
8-9  
Rule states that the applicant must submit confirmation of municipal compliance, specifically an attestation “that  
the applicant will report any changes that occur with municipal ordinances or zoning regulations that relate to the  
proposed marihuana facility . . . .”  
application  
This is very broad—any changes that occur with related municipal ordinances? What if an amendment is made  
but it is not publicly posted? Also, many municipal ordinances covering many topics may apply to the  
marihuana facility. It seems excessive to expect a licensee to monitor their municipality to report any ordinances  
that may apply. The rule should be written more narrowly to only reference “marihuana licensing or zoning  
specific” ordinances only.  
R 420.11a(5)  
Prelicensure  
investigation;  
proposed  
15-16  
Rule requires applicant to submit certificate of occupancy to agency for prelicensure inspection. If this  
certificate is not available, “the agency may accept alterative documentation from the building authority.”  
marihuana  
Some of our clients live in small townships without a building authority. I would like this definition to factor  
establishment  
inspection  
that scenario. For example, “from the building authority or other designated municipal official.”  
1
Rule Citation  
Rule Title  
Page  
Comments  
Number  
MARIJUANA LICENSEES  
R 420.105a(8)  
Class A  
7
Rule says “A Class A marihuana microbusiness may purchase or accept a mature plant from an individual,  
registered qualifying patient, or registered caregiver.  
marihuana  
microbusiness  
license  
What is the statutory authority for authorizing an individual, a registered qualifying patient, or a registered  
primary caregiver to sell mature marijuana plants to a Class A marijuana microbusiness?  
For clarity, this rule 112a should indicate that the phrase “licensing, management, or other agreement” is as  
defined in R420.101(1)(m).  
R 420.112a  
Licensing,  
management, or  
other agreements  
13-14  
It would appear that the purpose of this rule 112a is to identify agreements between a license holder and another  
person which are intended to convey the benefits of ownership on the non-license holder, when that non-license  
holder has not been vetted by MRA. If this is the actual purpose, the rule might be clearer if that were simply  
stated rather than covered by many words which seem to beat around the bush.  
MARIHUANA OPERATIONS  
R 420.206a  
Standing  
11  
Rule adds requirement for licensees to have up-to-date written standard operating procedures on site at all times.  
Operating  
Procedures  
Contactless and  
limited contact  
transactions  
Why is this required in addition to a facility or establishment plan?  
Rule allows licensees to designate area for contactless delivery. Section (4) requires separate standard operating  
procedure in addition to R 420.206a.  
R 420.207a(4)  
15-16  
Why can’t the standard operating procedures referenced in R 420.206a cover the contactless delivery? Why  
does it need to be a separate document?  
R 420.214b  
Adverse reactions 24  
Rule requires licensees to notify the MRA within 1 business day “of when licensee should have been aware of  
any adverse reactions to a marihuana product sold or transferred by any licensee.”  
First, the rule does not specify how the licensee should notify the MRA. Will the MRA provide notification  
forms? Is an email to enforcement sufficient?  
Second, the “should have been aware” language concerns me. If a licensee sells a product to a customer and the  
customer has a bad reaction after consuming the product 3 weeks later, how would the licensee even be aware of  
that reaction?  
MARIJUANA SALE OR TRANSFER  
R 420.303(6)  
Batch;  
identification and  
testing  
4
Rule allows a cultivator to sell/transfer marihuana products without being tested by a lab to produce live resin,  
with agency approval but limits the sales/transfer to a producer under this rule if the package contains more than  
1 harvest batch. The next line reads “This does not prohibit a cultivator from transferring multiple harvest  
batches for extraction.”  
This reads as internally conflicting and does not make sense, that a cultivator cannot use the testing exemption  
under the rule if they sell/transfer a package with more than one batch, but still can sell/transfer multiple batches.  
2
Rule Citation  
Rule Title  
Page  
Comments  
Number  
R. 420.305(16)(c)  
Testing;  
laboratory  
requirements  
10  
Rule prohibits a lab from “Cherry pick, which means testing specific material from a batch. All sample  
increments must have the same chances of being selected.”  
Practically, how can this even be enforced and it’s unclear what procedures, if any, a lab can put in place to  
ensure samples have the same chance of being selected.  
MARIJUANA SALE OR TRANSFER  
R 420.504(4)  
Marijuana product 4-5  
sale or transfer;  
labeling and  
New rule requires that both medical and retail sales location to provide customers with pamphlets that includes  
safety information related to marihuana use by minors and the poison control hotline number and that the  
pamphlet must substantially conform to the design published on the agency’s website.  
packaging  
requirements  
This new requirement seems duplicative given that the products already have labels with a safety warning. It also  
raises numerous practical issues, such as when these pamphlets have to be issued; what information has to be  
included in the pamphlets; the added cost which will be passed down to the customer/patient; for sales made  
online or via telephone, will this require some sort of digital pamphlet and if the Agency makes changes to the  
required information, will that require a whole new set of pamphlets and discarding the old ones?  
Rules limit the amount of internal product samples that can be given to an employee within a 30-day period to a  
total of 1 ounce of marihuana, a total of 2 grams of marihuana concentrate, and marihuana infused products with  
a total THC content of 2000 mgs. Further, R 420.509(7) requires that internal product samples be tested prior to  
transfer to its employees.  
R 420.508(8) and  
R 420.509(6)-(7)  
Trade samples  
Internal product  
samples  
8-9  
This new limitation and testing requirement seem overbroad and limits the ability of licensee’s to receive  
feedback from employees regarding the quality of the product/flower. Also, the testing requirement prior to  
transfer would mean that if a licensee is interested in knowing the quality of a product/flower before even  
deciding to put it to market, would have to pay the expensive testing requirements and would discourage  
product/flower improvement.  
MARIHUANA EMPLOYEES  
Generally, the changes are stylistic and help make some of the rules with listed requirements easier to read. The substance of most of the rules in this section has not  
changed.  
R 420.602(1)  
Employees;  
requirements  
2-4  
Rule has been modified to require employee training manuals to include detailed explanations for how  
employees can monitor and prevent over-intoxication, illegal distribution, etc. Previously, the rule only required  
such information to be in the employee manual if applicable.  
Generally, this isn’t a major burden for most licensees, but it seems like the previous language should be  
considered here, as this seems unnecessary for certain types of cannabis businesses.  
The major change is adding this rule, which prohibits employees of one type of licensee from being employees  
of another type. For example, employees of cultivators (growers) may not also be employed by transporters or  
labs.  
R 210.602a  
Prohibitions  
5
Do we know the reason for this addition? What is MRA trying to do here? The prohibition seems a little silly –  
are there similar prohibitions in the alcohol or tobacco industries?  
3
Rule Citation  
Rule Title  
Page  
Comments  
Number  
MARIHUANA HEARINGS  
As with Rule 601 et seq. above, most of the changes to these sections are stylistic and for readability purposes  
R 420.702(1)(d)  
Hearing  
The rule adds “the denial of the renewal of a marihuana license” to the situations where the “hearing” rules  
apply.  
procedures; scope  
and construction  
of rules  
This is an important addition.  
R 420.703(3)  
Public  
investigative  
hearing  
2-3  
4
Rule removes the specific requirements of what public investigators must provide in the contents of their notice  
to an applicant of an investigative hearing.  
It is unclear how often these public investigative hearings happen when a license is denied, and the degree to  
which this removal of specificity will impact applicants.  
Rule has been added, which provides a procedure for a marijuana business to contest MRA’s exclusion of a  
particular individual from the marijuana business.  
R 420.704a  
Hearing on  
exclusion of  
individuals or  
employees  
The procedures seem reasonable; however, subsection (1) allows the business only 21 days to contest MRA’s  
decision to exclude an individual. From our client’s perspective, this is not much time, and I would comment that  
maybe 45-60 days would be more helpful for our clients.  
MARIJUANA DISCIPLINARY PROCEEDINGS  
R 420.802(7)  
Notification and  
reporting  
3
For clarity, R420.802(7) should indicate that the phrase “licensing, management, or other agreement” is as  
defined in R420.801(1)(j).  
22355973  
4
September 9, 2021  
Samantha K. Balk  
Compliance Manager  
42 Degrees Processing, LLC  
C: 918-779-8192  
E: samantha@42-deg.com  
To the Marijuana Regulatory Agency:  
The following documentation encompasses the comments of myself and some of  
my coworkers in the marijuana industry regarding necessary clarifications and/or  
suggestions about the ruleset. I have it broken down by each rule.  
As the compliance manager at 42 Degrees Processing, LLC, a medical and adult  
use processing facility in Kalkaska, MI, my first priority is to protect our licenses by  
making sure that our facility is compliant with all requirements set forth by the  
MRA. Primarily, that goal is accomplished by a clearly defined set of rules to which  
can be adhered. What follows are observations based on the challenges I have  
faced as a compliance officer, as well as comments heard in the public. Any  
criticism and/or request is my own, but proposed as a means toward the end of  
clear rules that we can follow without further requirement for clarification. If any  
further clarification on my comments is required, I would be happy to take a phone  
call.  
My greatest concern is with the areas of potential loopholes. I may also mention  
cost, though this is frequently due to the cost of operations, which I must also be  
mindful of.  
Thank you very much for the time put into clarifying the ruleset and frequently  
providing guidance, most especially to me. And thanks to everyone at the MRA for  
providing and supporting this industry that I thoroughly enjoy, as it presents  
constant challenges that have given me a rewarding and important job here at 42  
Degrees.  
MARIHUANA DECLARATORY RULINGS  
● Definitions  
○ Define what is a “declaratory ruling”  
○ When would this be used instead of requesting a clarification on the  
interpretation of a rule?  
EMPLOYEES  
● R 420.602 Rule 2 (1) “A licensee shall conduct a criminal history  
background check…”  
○ Does this mean a state background check, federal background  
check, or both?  
○ Do subsequent background checks need to be performed after an  
employee has been hired? At what interval?  
SAMPLING AND TESTING  
● Definitions:  
○ The definition for a “production batch” needs to be clearer, especially  
considering edibles. If you would, please include this clear definition  
everywhere a rule discusses production batches.  
■ What defines similar conditions? Same operator, same pot,  
same tools, same formulation, etc. all should be considered.  
■ Is there a batch size limit?  
■ The current methodology across the industry as I understand  
it, from talking to testing laboratories, is that there are multiple  
pots of gummies being formulated in a linear fashion. First  
pot, then second pot, then third pot, etc, up until an indefinite  
number of pots, ie, 30-40 pots, defining a single production  
batch. However, from the standpoint of recipe and  
formulation, each pot could vary by a variety of small factors.  
One pot may get more color than another. One pot may get  
more THC distillate. Even if it is a small amount, it’s still not  
exactly the same. Although homogeneity testing is intended to  
account for this variation, it is only performed every 6 months  
after initial formulation and will not be able to capture if one  
pot of 30, 60, 100 (what even is the limit?) is out of sorts.  
Essentially, this is the same as considering 30-40 (or more)  
tiny single batches of gummies as one uniform batch. This  
presents potential safety concerns regarding dosing.  
○ The definition for a “production batch” needs to be more clearly  
defined for concentrates as well. If you would, please include this  
clear definition everywhere a rule discusses production batches.  
■ If two different production runs of extracted concentrate are  
mixed together, is that acceptable? It seems that it would be  
unlikely to mix two batches of concentrate together into a  
homogeneous mixture, which could yield a product of an  
inconsistent potency. For example, if you produce a  
concentrate that is 60% potency and mix it with a concentrate  
that is 80% potency, then the resulting product could be  
inconsistently mixed with a potency that varies between  
60-80%. This would be a more pronounced inconsistency if  
two different product consistencies were mixed, such as a  
“sugar” and a “sauce” together.  
● If this is acceptable, are any parameters needed?  
○ The definition for “final form” versus “in packaging” needs to be  
crystal clear.  
■ In some bulletins and rules, final form further clarifies that it  
means “not necessarily in its packaging for sale,” but in the  
laboratory testing handbook entitled Sampling and Testing  
Technical Guidance for Marijuana Products, it very clearly  
states “A sample of marijuana edible product must be in final  
form for a laboratory to accept this material for compliance  
testing. Laboratories are not permitted to sample product in  
bulk without packaging [italics mine] for compliance testing.  
Units should be easily distinguishable.”  
● We ended up changing around our entire standard  
operating procedure to accommodate having to test  
gummies in their sale packaging, only to then be  
corrected by a customer, who had an email from the  
MRA, stating that it was acceptable to test gummies  
prior to packaging.  
● R 420.306. Guidelines for retesting should be clearer. There were times in  
the past when the rule was not clear enough, as it stated that when a  
product failed a retest it must be destroyed. However, we found out after we  
destroyed it that remediation was allowed. The following clarifications are  
needed:  
○ Which failed tests can be retested. Please state these specifically  
(ie, heavy metals, certain pesticides, etc).  
○ How many times a retest can be performed. As written, it is currently  
allowable to retest as many times as needed until a passing result is  
achieved, which is an irresponsible practice.  
○ If retesting is permitted at a different lab than the one that delivered  
the failing result, and how that should be submitted if so.  
○ Is there a time limit on performing a retest, given that there’s now a  
90 day deadline for destruction?  
○ Which failed tests can be remediated. Please state these specifically  
(ie, heavy metals, certain pesticides, etc).  
● R 420.305, 9(h): states that potency should be reported in milligrams. It  
should read milligrams per ____.  
● R 420.307, Rule 7, 3: states that R&D testing is prohibited after compliance  
testing has been completed. This needs further clarification to cover the  
following:  
○ Continued quality studies, such as how a product might degrade or  
change over time.  
○ Reserving a subset of a finished product to perform additional small  
tests upon it not related to safety, such as terpene composition.  
○ It sounds as if the intent of the rule is to not perform R&D testing on  
the same production batch number, which historically created a  
problem in METRC by reverting Test Passed product into a Testing  
in Progress state. But if you pull an amount of and give it its own  
production batch number so as not to affect test results, would it be  
acceptable to perform R&D testing on this product?  
● Requiring safety compliance tests on small batches of new formulations  
makes formulating new products prohibitively expensive as the recipe or  
methodology might be tweaked several times prior to being finalized. We  
would be grateful if alternative rulings could be explored that allows for  
more creativity and flexibility as new products are developed.  
MARIHUANA SALE OR TRANSFER  
● Definitions:  
○ Need more clarification on types of transfers.  
■ Define what type of transfer should be used for which  
purposes. When to use them, which forms are required,  
where the forms are located, where to send requests, etc.  
● Specifically, we’ve had some trouble with untested WIP  
transfers, fresh frozen transfers, infusion transfers.  
● Some forms are simply not listed on the MRA’s  
website, such as the inventory transfer request form. It  
would be very helpful if all of the forms were listed in  
one location. Please investigate, and make compliance  
easier to do.  
● Ensure that METRC and AFS are cohesive for financial audits. The rules  
for processors make tracking monetary value back and forth unnecessarily  
cumbersome, as it has forced us to assign monetary value to something for  
which there was no cost (such as for toll processing, where we charge for  
services).  
● 420.508 (Trade Samples), Rule 8, 4, and 420.509 (Internal Samples), Rule  
9, 3: The rules need to clarify what needs to be recorded in METRC during  
sampling. It was clarified to me personally that I should be recording the ID  
and employee name for Internal sampling, and I have been recording the  
License and Vendor name for trade samples.  
○ Is any other information required for tracking purposes?  
○ It is possible that there needs to be a lot more definition regarding  
trade samples and employee samples in general. This rule has been  
the one I’ve been most aggressively questioned on as to what the  
MRA’s language allows versus what the MRA’s intent was when  
writing the rule.  
○ Rules are possibly unclear as to whether or not the Processor  
license is allowed to internally sample flower to its employees.  
○ The rules have an issue with loopholes regarding trade and internal  
samples, as follows:  
■ There is a limit on both internal samples and trade samples.  
However, when asked, and also provided with intent, the MRA  
clarified that they do not regulate sale prices. It is therefore  
possible for a processor to sell product to a retailer for a  
penny, who can then sell it to the processor’s own employees  
for a penny, and thus makes having a rule pertaining to limits  
pointless.  
● Which means it is also possible to do exactly the same  
thing for trade samples, and have either a  
representative of a retailer or a sales representative to  
purchase products for a penny and offer them for free  
to anyone.  
● The same could be said of coupons or rebates, or  
steep discounts of any kind. If there is the ability to  
legally obtain products for virtually nothing, then why  
bother with a limit at all?  
● Nothing currently prevents employees from giving all of  
their samples to someone else outside of work hours,  
either, which means that it is also possible for  
employees to band together and pool their samples for  
a single person, such as sales personnel.  
○ I also have concerns about the custody of products after trade  
sampling, as follows:  
■ It is currently stated that up to a certain limit, anyone may  
transport trade samples to a retailer. I do not think it is wise to  
allow anyone other than a secure transporter to transport  
products. There are a lot of strong relationships between  
retailer management and sales personnel, and I think it may  
be possible to abuse the trade sample mechanism to funnel  
products out of the regulated market in this manner. There is  
currently no control over ensuring that the trade sample  
actually makes it to the intended recipient in this manner.  
What is to stop a sales person from requesting samples for a  
retailer and simply never delivering them?  
■ We’ve heard that frequently, trade samples go only to retailer  
management and never make it into the hands of budtenders  
for the purpose of product sampling. I’m not sure that this  
would be considered an MRA problem, but wanted to bring it  
to your attention anyway, as trade samples handled in this  
matter do not bring much value to the processor value  
stream.  
○ Please clarify how a sample intended for an employee should be  
treated if the employee refuses the sample.  
■ Should it be destroyed? Does it now need two adjustments  
(one to put it back on its tag, and one to destroy it), or can it  
just go to destruction, since it has already been removed from  
METRC?  
● R 420.504 (Labeling and packaging requirements): Compliance stickers  
have been unclear for more than a year now. Clarification was promised but  
never came. Our customers have been told different things by the MRA  
which has now forced us to operate under two different SOPs. Please make  
this clearer as to which tags are required on the compliance label.  
○ Define that Package ID means the tag that is delivered to a retailer.  
■ We maintain that this should not actually be required. A store  
that receives the package will have the Source tag ID in their  
METRC should an issue with the customer’s product arise,  
which makes it easy to search. It is the source that would be  
the issue anyway if an adverse reaction was reported. Being  
allowed to label all of our products with only the Package’s  
Source ID and Testing ID would significantly improve  
operational efficiency and greatly reduce the amount of  
potential for error. If one batch were to be sent to 100 stores,  
this is the difference between being forced to create 100  
different compliance labels instead of only one.  
○ Define that Source ID is the parent tag of the Package ID regardless  
of testing status.  
○ Whether or not a Testing ID is required.  
■ Define that Testing ID is the tag that was delivered to the  
testing facility for the purpose of Safety Compliance Test only.  
○ Clarify how to treat a retest for potency when stating potency and  
testing facility information on the compliance label  
○ Remove “any” test analysis date, replace with “safety compliance”  
test analysis date.  
○ Release an example scenario or scenarios with an example label to  
eliminate all potential confusion.  
○ Clarify that the universal symbol must be printed in full color (green).  
○ Specify whether or not it is acceptable to say either marijuana or  
marihuana on the universal symbol.  
■ Basically, whether or not ANY modifications to the universal  
symbol are acceptable whatsoever.  
○ Specify that the words must be legible/easily read on the compliance  
label and universal symbol. Is a size requirement needed? Some of  
them are so tiny they cannot be read.  
● R 420.505 Rule 5. (1) Transferring needs two Rs.  
OPERATIONS  
● R 420.206, Rule 6, 14: “When combining more than 1 form of marihuana or  
marihuana product into a single marihuana product, each form of  
marihuana or marihuana product must have passing safety compliance test  
results in the statewide monitoring system prior to the creation of the new  
combined product.  
○ What defines a “form” of marihuana product?  
○ What if products are combined prior to a safety compliance test?  
Examples:  
■ Mixing a distillate with a high terpene content product, which  
will fill cartridges and go to safety compliance testing as a  
cartridge.  
■ Mixing together two concentrates, ie batter plus batter.  
● R 420.214a (Internal analytical testing):  
○ For the internal analytical testing area, what defines a “separate”  
testing area?  
● R 420.214b-c:  
○ How does a retailer return defective/undesirable products that are  
not involved in an adverse reaction to a processor if they are not  
allowed to transfer it back?  
■ For example, poor product quality, or if it has been on the  
shelf too long and they wish to trade it in.  
LICENSES  
● Definitions:  
○ Please include more clarity on separate areas.  
■ Food and marijuana areas are supposed to be kept separate.  
● Separation includes walls and a ceiling and a locked  
door.  
● Define the purpose of hallways, clarify the difference  
between a hallway and a room.  
○ No food or marijuana in hallways?  
○ Storage in hallways  
○ Carrying marijuana through the hallways to get  
to the next room  
○ Carrying food through the hallways to get to the  
next room.  
○ It was clarified to me that areas of different task types are also  
supposed to be maintained separately with a locked door between  
them, such as:  
■ Laboratory rooms can be connected, but not to packaging or  
storage  
■ Packaging rooms can be connected, but not to any production  
or storage  
■ Storage has to be kept separate from packaging and  
production.  
■ These are not terribly specific. Items will be stored temporarily  
in production areas. Does an edibles kitchen need to be  
separated from its own packaging operation? Where are the  
lines defined?  
■ Is this really necessary?  
■ Why is further security needed within the building when entry  
to the building itself is controlled by secure entry?  
○ Provide more specificity regarding the storage of inventory. Access  
should be restricted, but if it is behind a locked door and all the staff  
has access to the locked door, is it really restricted? So whom  
should have access?  
LICENSEES  
No questions  
MARIHUANA-INFUSED PRODUCTS AND EDIBLE MARIHUANA PRODUCTS  
● R 420.403, rule 3, 2: The potency variance has been changed to +/- 10%,  
not 15%. If this is not the case, there are multiple points throughout the rule  
set and bulletins where this variance is not in agreement.  
● 420.403, Rule 3, 10(a): There is currently no control expressed in the  
guidelines for an expiration date. It’s too arbitrary and does not require a  
product to demonstrate quality up until its expiration date. Documentation is  
required for shelf stability, but not for an expiration date qualification. This  
seems like an oversight.  
● 420.403, Rule 3, 9(e): Clarification is needed on what is considered a  
“commercially available food product”. This could feasibly eliminate most  
forms that an edible product might take, such as:  
○ Other types of candies:  
■ Chocolates  
■ Fudge  
■ Peanut butter cups  
○ Granola bars  
○ Rice krispies treats  
○ Brownies  
○ Cookies  
● 420.403, Rule 3, 9(f): Packaging specifications could use more clarity as  
well. “Not produce an edible marihuana product that is associated with or  
has cartoons, caricatures, toys, designs, shapes, labels, or packaging that  
would appeal to minors.”  
○ We’ve ruled out animals and fruit already. But there are other ways  
to appeal to children or teenagers. What about such things as:  
■ Vehicles such as sailboats, cars, trains, bicycles  
■ Color schemes, such as pastels, tie-dyes, bright colors, glitter  
■ Other icons, such as moon and stars, clouds, rainbows,  
flowers, gem stones.  
MARIHUANA HEARINGS  
No questions  
MARIHUANA DISCIPLINARY PROCEEDINGS  
● R 420.805, rule 5, 10-11: The list of excluded individuals is kept by the MRA  
and we do not currently have access to it. How are we going to be able to  
know that an individual has been excluded from employment or  
participation in a marihuana business? Would that come up in the  
background check?  
○ Also, we’d like to be able to see this list to protect ourselves and the  
integrity of the industry.  
OTHER QUESTIONS  
● With the limitations on names, shapes, and packaging that appeal to  
children, will there be further restrictions on the names of strains for  
concentrates and/or vapes?  
In conclusion,  
Thank you very much for your time and consideration in hearing comments from  
the public. I fully support clear rules, and greatly appreciate the time and effort that  
goes into refining this rule set.  
Sincerely,  
Samantha K. Balk  
Compliance Manager  
42 Degrees Processing, LLC  
Phone: 918-779-8192  
samantha@42-deg.com  
September 27, 2021  
Marijuana Regulatory Agency  
Legal Section  
P.O. Box 30205  
Lansing, MI 48909  
Via Email: MRA-Legal@michigan.gov  
Dear Marijuana Regulatory Agency (“MRA”):  
Thank you for the opportunity to comment on the proposed rule sets intended to promote clarity  
and consistency in Michigan’s medical and adult-use markets. Cresco Labs Michigan, LLC  
(“Cresco”) holds grower and processor licenses, operating a facility in Marshall. Cresco  
respectfully submits the following comments to the amended rule sets (proposed additions  
underlined in blue, proposed deletions in strikethrough red), which balance the clarity and  
flexibility necessary for operators with the interests of the program’s customers and patients and  
the other objectives essential to the implementation of a safe, secure and effective program:  
MARIHUANA DISCIPLINARY PROCEEDINGS  
R 420.802 Notification and reporting.  
[. . .]  
Rule 2.  
[. . .]  
(4) A licensee shall notify the agency within 1 3 business days of becoming aware or  
within 13 business days of when the licensee should have been aware of any of the  
following:;  
(a) Adverse reactions to a marihuana product sold or transferred by any licensee.  
(ba) Criminal convictions, charges, or civil judgments against a licensee in this state or any  
other state, federal, or foreign jurisdiction.  
(cb) Regulatory disciplinary action taken or determined against a licensee by this state or any  
other state, federal, or foreign jurisdiction, including any pending action.  
(c) Action by another party in actual or alleged violation of the acts or these rules.  
[. . .]  
Comment:  
Cresco respectfully urges the MRA to consider the above changes, which would afford operators  
a more reasonable period in which to report certain events. Allowing three businesses days rather  
than a single day would not be burdensome on the MRA and presents no risk to the public.  
Allowing license holders a small amount of additional time to understand whether an event must  
be reported, including with respect to new subsection (c), simply provides licensees with a fair  
amount of time in which to report events to the MRA.  
R 420.808a Exclusion.  
Rule 8a.  
Rule 8a. (1) A person may be excluded from employment at, or participation in, a  
marihuana business upon a finding of any of the following:  
[. . .]  
(e) The person is included on any valid and current exclusion list from  
another jurisdiction in the United States if the basis for the person’s inclusion  
on the exclusion list would also be grounds for exclusion as set forth in this  
Rule.  
[. . .]  
Comment:  
Cresco proposes to clarify the language set forth in the above rule, which would permit a person  
from being excluded from employment at, or participation in, a marihuana business based on that  
person’s exclusion from the cannabis industry in another state. Cresco submits that a person  
should only be excluded from participating in the cannabis industry in this state if the conduct or  
grounds for the person being excluded in another state would result in exclusion in this state.  
Absent clarification such as the above, an otherwise qualified individual may be prevented from  
participating in the Michigan cannabis industry for conduct that may acceptable under Michigan  
law.  
MARIHUANA-INFUSED PRODUCTS AND EDIBLE MARIHUANA PRODUCT  
R 420.403 Requirements and restrictions on marihuana-infused products; edible  
marihuanaproduct.  
Rule 3.  
[. . .]  
(7) A producer shall label all marihuana-infused product with all of the following:  
(a) The name of the marihuana-infused product. The name of the product must be an  
appropriately descriptive phrase that accurately describes the basic nature of the product.  
[. . .]  
(2) A producer of edible marihuana product shall comply with all the following:  
(a) Edible marihuana product packages shall nNot be in produce an edible marihuana  
product in a shape or with a labeled in a manner that would appeal to minors aged 17 years  
oryounger. Edible marihuana products shall not be associated with or have cartoons,  
caricatures,toys, designs, shapes, labels, or packaging that would appeal to minors.  
(b) Not produce an edible marihuana product that is associated with or has  
cartoons,caricatures, toys, designs, shapes, labels, or packaging that would appeal to  
minors.  
(bc) Not produce Eedible marihuana products shall not be that can be easily confused with a  
commercially sold candy available food product. The use of the word candy or candies on the  
packaging or labeling is prohibited. Edible marihuana products shall not be in the distinct shape  
of a human, animal, or fruit, or a shape that bears the likeness or contains characteristics of a  
realistic or fictional human, animal, or fruit, including artistic, caricature, or cartoon renderings.  
Edible marihuana products that are geometric shapes and simply fruit flavored are permissible.  
[. . .]  
(9) A producer of edible marihuana product shall comply with all the following:  
(a) Edible marihuana product packages shall nNot be in produce an edible marihuana  
product in a shape or with a labeled in a manner that would primarily appeal to minors  
aged 17 years oryounger. Edible marihuana products shall not be associated with or have  
cartoons, caricatures,toys, designs, shapes, labels, or packaging that would appeal to minors.  
(b) Not produce an edible marihuana product that is associated with or has cartoons,  
caricatures, toys, designs, shapes, labels, or packaging that would primarily appeal to  
minors.  
[. . .]  
(10) A producer shall not produce an edible marihuana product that requires time and  
temperature control for safety. The agency may publish validation guidance for shelf  
stable edible marihuana product. The agency may request to review the validation study  
for a shelfstable edible marihuana product. The end product must be a shelf stable edible  
marihuana product and state the following information:  
(a) A product expiration date, upon which the marihuana product is no longer fit  
for consumption and after which it must be destroyed. Once a label with an  
expiration date has been affixed to a marihuana product, a licensee shall not alter that  
expiration date or affix a newlabel with a later expiration date. The expiration date  
must consider all the following:  
(i) The quality and characteristics of the edible marihuana product.  
(ii) The packaging of the edible marihuana product.  
(iii) The customary conditions encountered by the edible marihuana product from  
product to sale.  
[. . .]  
Comment:  
With regard to the proposed amendment to subsection (7)(a) above, which would require operators  
to label products in a descriptive manner that accurately describes the basic nature of the product,  
Cresco respectfully asks the MRA to provide further clarify to operators. While Cresco  
understands the proposed rule to echoes recent packaging guidance issued by the MRA, the  
proposed rule is not precise and leaves operators to interpret the MRA’s intent with this additional  
language. Packaging and labeling changes take substantial time to design, implement, and  
purchase and changes cannot be made easily. Accordingly, to the extent the MRA can provide  
more specificity, codified in the rule, such would be to the benefit of both operators and the agency  
and would avoid costly changes to packaging that take considerable time to effectuate.  
Regarding subsections (9)(a) and 9(b), Cresco suggests the above change that more accurately  
reflects the intent of the rule and balances an operator’s ability to build brands and design  
packaging creatively while ensuring that such packaging is not aimed to the appeal of minors.  
Employment the qualifier “primarily” or “likely” is in line with other adult use jurisdictions and  
serves to accomplish the aim of the rule change.  
Additionally, related to subsection (10)(a)(i), Cresco seeks clarity from the MRA as to what is  
meant by the phrase “quality and characteristics of the edible marihuana product.” As drafted, this  
new language is subject to interpretation and is not defined within the amended rules. As a result,  
Cresco asks the MRA to consider providing further clarifying language to provide operators the  
necessary transparency to comply with the new rule.  
MARIHUANA LICENSEES  
R 420.106 Marihuana secure transporter license.  
Rule 6. (1) A marihuana secure transporter license authorizes the licensee to store and transport  
marihuana and money associated with the purchase or sale of marihuana between marihuana  
establishments for a fee upon request of a person with legal custody of that marihuana or  
money.It does not authorize transport to a registered qualifying patient or registered primary  
caregiver. If a marihuana secure transporter has its primary place of business in a municipality  
that has notadopted an ordinance under section 6 of the MRTMA, MCL 333.27956, prohibiting  
marihuana establishments, the marihuana secure transporter may travel through any  
municipality  
[. . .]  
Comment:  
Cresco respectfully asks that the MRA consider permitting operators to self-distribute to entities  
under common ownership if an operator meets the requirements set forth in the secure transporters  
Rule 420.106, set forth in part above.  
R 420.101 Definitions.  
[. . .]  
(cd) "Applicant" means a person who applies for a marihuana license, subject to paragraphs (i)  
and (ii) of this subrule:  
(i) For purposes of this definition, an applicant includes a managerial employee of the  
applicant, a person holding a direct or indirect ownership interest of more than 10% in theapplicant,  
and the following for each type of applicant:  
[. . .]  
(F) For a publicly held corporation: all corporate officers or persons with equivalent titles and  
their spouses, all directors and their spouses, all stockholders, not including those holding a direct  
or indirect ownership interest of 10% or less, and their spouses.  
[. . .]  
Comment:  
Cresco urges the MRA to consider the above changes to remove “spouses” from the definition of  
applicant with respect to publicly held corporations. Simply stated, the spouses of corporate  
officers, persons with equivalent titles, directors, and certain stockholders should not be construed  
as applicants under the law. Indeed, Michigan stands as an outlier in making such a determination,  
which only serves to burden applicants with additional disclosures not required in other similarly  
situated jurisdictions and does not advance any goal the state may have with regard to transparency.  
PART 3. AGREEMENTS  
R 420.112a Licensing, management, or other agreements.  
Rule 12a. (1) A licensee may contract with another party to use the other  
party’s intellectual property or for the other party to provide management  
or other services necessary for the operation of the licensee pursuant to a  
licensing, management, or otheragreement approved by the agency.  
(2) A licensee shall submit a complete, unredacted, signed copy of the licensing,  
management, or other agreement to the agency for review and approval prior to  
performance under the agreement. Approval by the agency indicates an agency  
determination that it does not appear based upon the information provided that the  
otherparty meets the definition of applicant.  
(3) The agreement must include, but is not limited to, all of the following:  
[. . .]  
Comment:  
While Cresco understands the intent behind the MRA’s propose rule, set forth above, and takes no  
issue with providing a licensing, management, or other agreement to the MRA for review to  
confirm that any third party does not meet the definition of an applicant, Cresco respectfully urges  
the MRA to take another approach with respect to the requirements set forth in the proposed rule.  
As currently drafted, the MRA’s requirements come close to dictating the terms of a business  
agreement, which Cresco respectfully suggests goes beyond the role of a regulator and is not the  
ultimately intent here. As an alternative approach, Cresco proposes the above rule be amended to  
plainly set forth what is prohibited from inclusion in such agreements rather than a list of required  
terms. Such an approach would still provide the MRA discretion over agreements but would not  
otherwise restrict the terms of such agreements (other than that certain terms cannot be included  
in such agreements).  
MARIHUANA LICENSES  
R 420.1 Definitions.  
Rule 1. (1) As used in these rules:  
[. . .]  
(a) "Applicant" means a person who applies for a marihuana license, subject to paragraphs  
(i)and (ii) of this subdivision:  
(i) For purposes of this definition, an applicant includes a managerial employee of  
the applicant, a person holding a direct or indirect ownership interest of more than 10%  
in theapplicant, and the following for each type of applicant:  
[. . .]  
(F) For a publicly held corporation: all corporate officers or persons with equivalent titles  
and their spouses, all directors and their spouses, all stockholders, not including those holding  
a direct or indirect ownership interest of 10% or less, and their spouses.  
Comment:  
Once again, as set forth above, Cresco urges the MRA to consider removing “spouses” from the  
definition of applicant with respect to publicly held corporations. The spouses of corporate  
officers, persons with equivalent titles, directors, and certain stockholders should not be construed  
as applicants under the law. Indeed, Michigan stands as an outlier in making such a determination,  
which only serves to burden applicants with additional disclosures not required in other similarly  
situated jurisdictions and does not advance any goal the state may have with regard to transparency.  
R 420.4 Application requirements; financial and criminal background.  
Rule 4. (1) Each applicant shall disclose the identity of any other person who controls, either  
directly or indirectly, the applicant, including, but not limited to, date of birth, government issued  
identification, and any other documents required by the agency.  
(2) Each applicant shall disclose the financial information required in the acts and these rules  
ona form created by the agency, including the following:  
(a) For an applicant seeking licensure under the medical marihuana facilities  
licensingactMMFLA, required information includes, but is not limited to, all of the  
following:  
(i) Financial statements regarding all of the following:  
(A) A pecuniary interest.  
(B) Any deposit of value of the applicant or made directly or indirectly to the applicant,  
orboth.  
(C) Financial accounts including, but not limited to, all of the following: funds, savings,  
checking, or other accounts including all applicable account information, such as the name of  
thefinancial institution, names of the account holders, account type, account balances, and a  
list of all loans types specified by the agency, amounts, securities, or lender information.  
(ii) Property ownership information, including, but not limited to, deeds, leases,  
rentalagreements, real estate trusts, or purchase agreements.  
(iii) Tax information, including, but not limited to, W-2 and 1099 forms, and any  
otherinformation required by the agency.  
(iv) Disclosure by the applicant of the identity of any other person who meets either  
of thefollowing:  
[. . .]  
(b) For an applicant seeking licensure under the Michigan regulation and taxation  
of marihuanaact MRTMA required information includes, but is not limited to, all of  
the following is required:  
(i) Tax information, including, but not limited to:  
(A) W-2 forms for the most recent tax year.  
(B) 1099 forms for the most recent tax year.  
(ii) Any other information required by the agency.  
[. . .]  
(3) Each applicant shall disclose all shareholders holding a direct or indirect interest of greater  
than 5%, officers, and directors in the proposed marihuana establishment. Each applicant shall  
disclose the identity of every person having a 2.5% or greater ownership interest in the  
applicant with respect to which the license is sought.  
[. . .]  
(c) If the disclosed entity is a publicly held corporation, the names and addresses of all  
shareholders holding a direct or indirect interest of greater than 5%, officers, and directors.  
Comment:  
As an initial matter, Cresco seeks clarification regarding subsections (2)(a) and (2)(b) of Rule 4,  
which appear to set forth different requirements for applicants in the medical and adult use  
programs in terms of financial information required to be disclosed. Cresco respectfully proposes  
that the MRA seek to align these requirements for consistency and to create parity between the  
programs. Further, to the extent disclosures are not accompanied by any temporal limitations,  
Cresco proposes that the MRA take steps to limit the information required to be produced. For  
example, an applicant under the MMFLA must produce tax information (see subsection (2)(a)(iiii))  
whereas an applicant under the MRTMA must produce tax information for the most recent tax  
year (see subsection (2)(b)(i)).  
Further, Cresco seeks clarity from the MRA as to the required disclosures applicable to a publicly  
held corporation. The definition of applicant in Rule 420.1 defines an applicant as a person holding  
an interest of more than 10% in the applicant while subsection (3) of this rule mandates disclosure  
of the identity of every person having a 2.5% or greater ownership interest and subsection (3)(c)  
requires a publicly held corporation to disclose certain persons holding a 5% of greater interest in  
the business.  
R 420.13 Renewal of marihuana license.  
Rule 13.  
[. . .]  
(c) For an applicant seeking renewal of a license under the MMFLA, confirmation of  
municipal compliance on an attestation form provided by the agency that includes all of the  
following Aattestation by the municipality on a form created by the agency regarding a licensee  
who submits an application for marihuana license renewal which shall include, but not be limited  
to, both of the following:  
(i) A description of any violation, if applicable, of an ordinance or a zoning regulation  
adoptedpursuant to section 205 of the medical marihuana facilities licensing actMMFLA,  
MCL 333.27205, or section 6 of the Michigan regulation and taxation of marihuana act, MCL  
333.27956, committed by the licensee, but only if the violation relates to activities licensed  
underthe acts or these rules.  
(ii) Whether there has been a change to an ordinance or a zoning regulation adopted pursuant  
to section 205 of the medical marihuana facilities licensing actMMFLA, MCL 333.27205, or  
section 6 of the Michigan regulation and taxation of marihuana act, MCL 333.27956, since the  
marihuana license was issued to the licensee and a description of the change.  
(iii) The date and signature of the clerk of the municipality or his or her designee.  
(iv)The date and signature of the applicant.  
(v)The name and address of the marihuana facility.  
(vi) The license type of the marihuana facility.  
(d) For an applicant seeking renewal of a license under the MRTMA, confirmation of  
municipal compliance on an attestation form provided by the agency that includes all of  
the following:  
(i) A description of any violation, if applicable, of an ordinance or a zoning  
regulation consistent with section 6 of the MRTMA, MCL 333.27956, committed by  
the licensee, butonly if the violation relates to activities licensed under the act or these  
rules.  
(ii) Whether there has been a change to an ordinance or a zoning regulation  
consistent with section 6 of the MRTMA, MCL 333.27956, since the marihuana license  
was issued tothe licensee and a description of the change.  
(iii) The following information for the municipality where the marihuana  
establishmentis located, including, at a minimum, all of the following:  
(A) The name and address of the marihuana establishment.  
(B) The license type of the marihuana establishment.  
(C) The municipality where the marihuana establishment is located.  
(D) The contact information for the municipality, including, at a minimum, all of  
thefollowing:  
(I) The name of the clerk of the municipality or his or her designee.  
(II) The telephone number of the clerk of the municipality or his or her designee.  
(III) The email address of the clerk of the municipality or his or her designee.  
(IV) The mailing address of the clerk of the municipality or his or her designee.  
(iv) Confirmation that the municipality has not adopted an ordinance prohibiting  
theproposed marihuana establishment.  
(v) Confirmation that the applicant is in compliance with any ordinance the  
municipalityhas adopted relating to marihuana establishments within its jurisdiction,  
including zoning regulations.  
(vi) Attestation that the applicant will report any changes that occur with municipal  
ordinances or zoning regulations that relate to the marihuana establishment, any  
municipal establishment approvals, or any violations of a municipal or zoning  
regulation.  
The date and signature of the applicant.  
[. . .]  
Comment:  
With respect to the requirements of the above Rule, Cresco asks that the MRA consider the scope  
of information required of municipalities and how to address situations where a licensee may be  
unable to procure the necessary information in a timely fashion from a municipality so that the  
licensee may continue to serve patients and customers without disruption.  
R 420.14 Notification and reporting.  
[. . .]  
(4) An applicant shall notify the agency within 13 business days of becoming aware of or  
within 13 business days of when the applicant should have been aware of any of the following:  
[. . .]  
Comment:  
Cresco respectfully urges the MRA to consider the above change, which would afford operators a  
more reasonable period in which to report certain events. Allowing three businesses days rather  
than a single day would not be burdensome on the MRA and presents no risk to the public.  
Affording license holders a small amount of additional time to understand whether an event must  
be reported simply provides licensees with a fair amount of time in which to report events to the  
MRA.  
MARIHUANA OPERATIONS  
R 420.1 Definitions.  
Rule 1. (1) As used in these rules:  
[. . .]  
(d) "Applicant" means a person who applies for a marihuana license, subject to paragraphs (i)  
and (ii) of this subdivision:  
(i) For purposes of this definition, an applicant includes a managerial employee of the  
applicant, a person holding a direct or indirect ownership interest of more than 10% in the  
applicant, and the following for each type of applicant:  
[. . .]  
(F) For a publicly held corporation: all corporate officers or persons with equivalent titles and  
their spouses, all directors and their spouses, all stockholders, not including those holding a direct  
or indirect ownership interest of 10% or less, and their spouses.  
Comment:  
As stated above, Cresco respectfully asks the MRA to consider removing “spouses” from the  
definition of applicant with respect to publicly held corporations. The spouses of corporate  
officers, persons with equivalent titles, directors, and certain stockholders should not be construed  
as applicants under the law. As noted above, Michigan stands as an outlier in making such a  
determination, which only serves to burden applicants with additional disclosures not required in  
other similarly situated jurisdictions and does not advance any goal the state may have with regard  
to transparency.  
R 420.206 Marihuana business; general requirements.  
Rule 6.  
[. . .]  
(13) All ingredients containing cannabinoids, whether naturally occurring or  
synthetically derived, that are added to marihuana or marihuana products must be from a  
source licensed to grow, handle, and produce cannabinoids under a license issued by  
a governmental authority and entered into the statewide monitoring system.  
(14) When combining more than 1 form of marihuana or marihuana product into a  
single marihuana product, each form of marihuana or marihuana product must have  
passing safety compliance test results in the statewide monitoring system prior to the creati  
on of the new combined product.  
[. . .]  
Comment:  
Cresco respectfully seeks clarification from the MRA regarding the meaning of the above  
language. Specifically, does the MRA intend subsection (13) of Rule 6 to mean an operator can  
procure hemp-derived cannabinoids from outside of Michigan as long as the source of the  
cannabinoids is licensed in the state in which it operates and the product passes testing, as set forth  
in subsection (14).  
R 420.207 Marihuana delivery; limited circumstances.  
Rule 7.  
[. . .]  
(9) To ensure the integrity of the marihuana sales location operation, a A marihuana  
delivery employee shall comply with all the following:  
[. . .]  
(d) A marihuana delivery employee shall not carry marihuana product in the delivery  
vehicle with a value in excess of $5,000.00 (pre-tax retail value) at any time. The value of  
marihuana products carried in the delivery vehicle for which a delivery order was not received  
and processed by the licensed retailer prior to the delivery employee departing from the  
marihuana sales location may not exceed $3,000.00 (pre-tax retail value). For the purposes of  
this subrule, the value of marihuana products must be determined using the current retail price  
of all marihuana products carried by, or within the delivery vehicle of, the marihuana delivery  
employee.  
[. . .]  
Comment:  
Cresco respectfully asks the MRA to consider the above change to clarify that value of products  
is measured before tax. Such is a reasonable clarification and would be easier for operators to  
navigate compared to determining product value post-tax.  
R 420.214b Adverse reactions.  
Rule 14b. (1) A licensee shall notify the agency within 13 business days of becoming  
aware or within 1 business day of when the licensee should have been aware of any  
adverse reactions to a marihuana product sold or transferred by any licensee.  
(2) A licensee shall enter into the statewide monitoring system within 13 business days  
of becoming aware of or within 1 business day of when the licensee should have been  
aware of any adverse reactions to a  
marihuana product sold or transferred by any licensee.  
Comment:  
As an initial point, Cresco requests the MRA to consider the above change, which would afford  
operators a more reasonable period in which to report certain events. Allowing three businesses  
days rather than a single day would not be burdensome on the MRA and presents no risk to the  
public. Further, permitting license holders a small amount of additional time to understand whether  
an adverse reaction has actually occurred must be reported provides licensees with a fair amount  
of time in which to report adverse reactions.  
Additionally, Cresco asks the MRA to consider eliminating language that would mandate a  
licensee to report (and enter information into the statewide monitoring system) within one business  
day of when the licensee “should have been aware” of an adverse reaction occurred. Licensees can  
only fairly report information they are aware of and it is unclear, as a general matter, how a licensee  
can report and enter information concerning an event which they were not aware of but “should  
have been.” As a result, Cresco proposes the above changes to Rule 420.214b.  
R 420.214c Product returns.  
Rule 14c. (1) A marihuana sales location may accept the return of marihuana product  
that is reported to have caused an adverse reaction or is determined to be defective.  
(2) A marihuana sales location must have a written policy for the return of marihuana  
product that contains, at a minimum, the following:  
[. . .]  
(g) A marihuana retailer may return a marihuana product that is past its expiration date  
to the marihuana processor who produced the marihuana product for destruction or  
retesting and/or remediation instead of destroying the marihuana product.  
Comment:  
Cresco respectfully asks the MRA to consider permitting operates to retest and remediate, as  
necessary, any product that has been returned as being past an expiration date. With appropriate  
testing and/or the application of remediation, a product can be assured as appropriately dispensed  
to the public. Such would avoid the unnecessary destruction of products to the expense of operators  
and ultimately to patients and customers who would not have that product available.  
MARIHUANA SAMPLING AND TESTING  
R 420.303 Batch; identification and testing.  
Rule 3.  
[. . .]  
(6) A cultivator may transfer or sell fresh frozen or dry marihuana to a producer without first  
being tested by a laboratory in order to produce fresh frozen live resin or rosin, or if the marihuana  
product willbe refined to a concentrate extracted, with agency approval. A cultivator may not  
transfer or sell marihuana to a producer under this rule if the package contains more than  
1 harvest batch. This does not prohibit a cultivator from transferring multiple harvest  
batches for extraction. After the producer has processed extracted the material, the producer  
shall have the sample tested for all required safety tests pursuant to R 420.304 and R 420.305. A  
producer that received a package under this rule that has not been processed may transfer  
that package to another producer without having the package first tested by a laboratory to  
produce live resin or rosin or concentrate with agency approval. The agency may publish  
guidance for fresh frozen and concentrate production, transfer, and sale.  
Comment:  
Cresco asks the MRA to consider the above changes which would provide operators with  
flexibility while continuing to ensure products meet testing standards before being dispensed to  
patients or customers. As drafted, the above rule would permit the transfer of fresh frozen  
marijuana to a producer to make live resin or marihuana extract without first being tested, with  
MRA approval. Cresco proposes that rosin be included in the above amended regulation, as a  
reasonable expansion of this amended rule. Cresco further suggests that the ability to transfer  
biomass intended for extraction should not be limited to fresh frozen marihuana and should also  
include dry marihuana. And finally, Cresco proposes removing the requirement that an operator  
must request and receive approval before transferring materials that will be subject to extraction.  
The above modifications serve to reasonably expand the intent of the rule and would not result in  
untested product being offered for sale. Indeed, the above modifications further the purpose of the  
rule change, by permitting the transfer of biomass that will be subject to extraction without  
requiring that the marihuana be subject to a pre-transfer test and then tested again following  
extraction.  
MARIHUANA EMPLOYEES  
R 420.601 Definitions.  
Rule 1. (1) As used in these rules:  
[. . .]  
(de) “Employee” means, except as otherwise provided in these rules, a person performing work  
or service for direct compensation from the marihuana establishment. “Employee” does not  
include individuals providing trade or professional services who are not normally engaged in the  
operation of a marihuana establishment.  
[. . .]  
Comment:  
Cresco proposes the above changes to the definition of employee in this rule set—and in other rule  
sets that employs the same definition of employee—as the current definition is overly broad. By  
enacting the above changes, the definition more clearly defines the term “employee.”  
Thank you for the opportunity to comment on these proposed rule sets. Cresco welcomes the  
opportunity to provide the MRA with any additional feedback or information.  
Sincerely,  
Cresco Labs Michigan, LLC  
DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS  
MARIJUANA REGULATORY AGENCY  
MARIHUANA SAMPLING AND TESTING  
Filed with the secretary of state on  
These rules take effect immediately upon filing with the secretary of state unless adopted under  
section 33, 44, or 45a(6)(9) of the administrative procedures act of 1969, 1969 PA 306, MCL  
24.233, 24.244, or 24.245a. Rules adopted under these sections become effective 7 days after  
filing with the secretary of state.  
(By authority conferred on the executive director of the marihuana marijuana regulatory agency  
by section 206 of the medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,  
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018 IL 1, MCL  
333.27957 and 333.27958, and Executive Reorganization Order No. 2019-2, MCL 333.27001)  
R 420.301, R 420.302, R 420.303, R 420.304, R 420.305, R 420.306, and R 420.307 of the  
Michigan Administrative Code are amended, and R 420.303a, R 420.305a, and R 420.305b are  
added, as follows:  
R 420.301 Definitions.  
Rule 1. (1) As used in these rules:  
(a) “Action limit” means the maximum permissible level of a contaminant in marihuana  
product allowable by the agency.  
(b) “Acts” refers to the medical marihuana facilities licensing act, 2016 PA 281, MCL  
333.27101 to 333.27801, and the Michigan Regulation and Taxation of Marihuana Act, 2018 IL  
1, MCL 333.27951 to 333.27967, when applicable.  
(c) “Agency” means the marijuana regulatory agency.  
(d) “Batch” means all marihuana product of the same variety that has been processed together  
and exposed to substantially similar conditions throughout processing.  
(e) “Bureau of fire services” or “BFS” means the bureau of fire services in the department of  
licensing and regulatory affairs.  
(fe) “Cultivator” refers to a grower under the medical marihuana facilities licensing act or a  
marihuana grower under the Michigan rRegulation and tTaxation of mMarihuana aAct, or both.  
(f) “Employee” means, except as otherwise provided in these rules, a person performing  
work or service for compensation. “mployee” does not include an individual providing  
trade or professional services who is not normally engaged in the operation of a marihuana  
establishment.  
(g) “Final form” means the form a marihuana product is in when it is available for sale by a  
marihuana sales location. For marihuana products intended for inhalation, “final form” means  
the marihuana concentrate in the an e-cigarette or a vaping device.  
(h) “Good agricultural collection practices” or “GACP-GMP” means the World Health  
Organizations Organization’s or the American Herbal Products Associations Association’s  
July 19, 2021  
2
guidelines regarding the safety, efficacy, and sustainability of medicinal plant material being  
used in herbal medicines.  
(i) “Good manufacturing practices” or “GMP” means the Food and Drug Administration’s  
formal regulations regarding the design, monitoring, control, and maintenance of manufacturing  
processes and facilities. They are designed to ensure that products manufactured are to specific  
requirements including identity, strength, quality, and purity.  
(j) “Harvest batch” means a designated quantity of harvested marihuana, all of which is  
identical in strain and has been grown and harvested together and exposed to substantially  
similar conditions throughout cultivation.  
(k) "Immature plant” means a nonflowering marihuana plant that is no taller than 8 inches from  
the growing or cultivating medium and no wider than 8 inches produced from a cutting, clipping,  
tissue culture, or seedling that is in a growing or cultivating medium or in a growing or  
cultivating container.  
(l) “Inactive ingredients” means binding materials, dyes, preservatives, flavoring agents, and  
any other ingredient that is not derived from the plant Cannabis Ssativa L.  
(m) “Laboratory” refers to both a safety compliance facility under the medical marihuana  
facilities licensing act and a marihuana safety compliance facility under the Michigan  
rRegulation and tTaxation of mMarihuana aAct.  
(n) “Limit of quantitation” or “LOQ” means the minimum concentration or mass of an analyte  
in a given matrix that can be reported as a quantitative result.  
(o) “Marihuana business” refers to a marihuana facility under the medical marihuana facilities  
licensing act or a marihuana establishment under the Michigan rRegulation and tTaxation of  
mMarihuana aAct, or both.  
(p) “Marihuana establishment” means a location at which a licensee is licensed to operate a  
marihuana grower, marihuana safety compliance facility, marihuana processor, marihuana  
microbusiness, class A marihuana microbusiness, marihuana retailer, marihuana secure  
transporter, marihuana designated consumption establishment, or any other type of marihuana-  
related business licensed to operate by the agency under the Michigan rRegulation and tTaxation  
of mMarihuana aAct.  
(q) “Marihuana facility” means a location at which a licensee is licensed to operate under the  
medical marihuana facilities licensing act.  
(r) “Marihuana product” means marihuana or a marihuana-infused product, or both, as those  
terms are defined in the act unless otherwise provided for in these rules.  
(s) “Marihuana sales location” refers to a provisioning center under the medical marihuana  
facilities licensing act or a marihuana retailer under the Michigan rRegulation and tTaxation of  
mMarihuana aAct, or both.  
(t) “Marihuana tracking act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901  
to 333.27904.  
(u) “Medical marihuana facilities licensing act” or “MMFLA” means the medical marihuana  
facilities licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.  
(v) “Michigan rRegulation and tTaxation of mMarihuana aAct” or “MRTMA” means the  
Michigan Regulation and Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.  
(w) “Package tag” means an RFID tag supplied through the statewide monitoring system for  
the purpose of identifying a package containing a marihuana product.  
x) “Plant tag” means an RFID tag supplied through the statewide monitoring system for the  
purpose of identifying an individual marihuana plant.  
3
(y) “Pre-testing” means to performing full compliance testing on samples, then not without  
reporting the results to the agency, and reporting results of subsequent testing to the agency.  
(z) “Proficiency testing” means a test that determines the performance of individual  
laboratories for specific tests or measurements and is used to monitor laboratories’ continuing  
performance.  
(aa) “Producer” refers to both a processor under the medical marihuana facilities licensing act  
and a marihuana processor under the Michigan rRegulation and tTaxation of mMarihuana aAct.  
(bb) “These rules” means the administrative rules promulgated by the agency under the  
authority of the medical marihuana facilities licensing act, the marihuana tracking act, the  
Michigan rRegulation and tTaxation of mMarihuana aAct, and Executive Reorganization Order  
No. 2019-2, MCL 333.27001.  
(cc) “Tag” or “RFID tag” means the unique identification number or Radio Frequency  
Identification (RFID) issued to a licensee by the agency statewide monitoring system for  
tracking, identifying, and verifying marihuana plants, marihuana products, and packages of  
marihuana product in the statewide monitoring system.  
(dd) “Target analyte” means a non-marihuana inactive ingredient designated for analysis.  
(2) Terms defined in the acts have the same meanings when used in these rules unless otherwise  
indicated.  
R 420.302 Adoption by reference.  
Rule 2. (1) The following codes, standards, or regulations of nationally recognized  
organizations or associations are adopted by reference in these rules:  
) AOAC International Official Methods of Analysis, 21st edition. Copies of the adopted  
provisions are available for inspection and distribution from the Association of Official  
Analytical Collaboration (AOAC) International AOAC International, 2275 Research  
Boulevard, Suite 300, Rockville, Maryland, 20850, telephone number 1-800-379-2622, for the  
price of $870.00.  
(b) National fire protection association (NFPA) standard 1, 201821 edition, entitled “Fire  
Code,” is adopted by reference as part of these rules. Copies of the adopted provisions are  
available for inspection and distribution from the National Fire Protection Association, 1  
Batterymarch Park, P.O. Box 9101, Quincy, Massachusetts, 02169, telephone number 1-800-  
344-3555, for the price of $106.00114.50.  
(c) The International Organization for Standardization (ISO), ISO 22000 / ISO/TS 22002-  
1:2009, - fFood sSafety bBundle, available for purchase at:  
https://webstore.ansi.org/Standards/ISO/ISO22000TS22002FoodSafety, for the price of $275.00.  
(d) International Organization for Standardization (ISO), ISO/IEC 17025:2017, gGeneral  
rRequirements for the cCompetence of tTesting and cCalibration lLaboratories, available at:  
https://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2fIEC+17025%3a2017, for the price of  
$162.00.  
(2) The standards adopted in subrule (1)(a) to (d) of this rule are available for inspection and  
distribution at the agency, located at 2407 North Grand River Avenue, Lansing, MIMichigan,  
48906. Copies of these standards may be obtained from the agency at the cost indicated in  
subrule (1)(a) to (d) of this rule, plus shipping and handling.  
4
R 420.303 Batch; identification and testing.  
Rule 3. (1) A cultivator shall uniquely identify each immature plant batch with a single plant  
tag batch name and record the information in the statewide monitoring system. Each immature  
plant batch must consist of no more than 100 immature plants.  
(2) A cultivator shall tag each individual plant that is greater than 8 inches in height from the  
growing or cultivating medium or more than 8 inches in width with an individual plant tag and  
record the identification information in the statewide monitoring system.  
(3) A cultivator shall separate the plants as the plants go through different growth stages and  
ensure that the plant tag is always identified with the plant throughout the growth span growing  
cycle so that all plants can be easily identified and inspected. A cultivator shall ensure that  
identification information is recorded in the statewide monitoring system in accordance with the  
acts, the marihuana tracking act, and these rules.  
(4) After A ultivator shall immediately destroy the individual plant tag once a tagged plant  
is harvested, it and is part of a harvest batch so that a sample of the harvest batch can be tested  
by a licensed laboratory as provided in R 420.304 and R 420.305. A cultivator shall separate the  
harvest batch by product type and quarantine a harvest batch the harvested batch from all  
other plants or batches marihuana and marihuana products when the marihuana batch has  
that have test results pending. A harvest batch must be easily distinguishable from other harvest  
batches until the batch is broken down into packages. A cultivator may not combine harvest  
batches.  
(5) Before the cultivator transfers or sells the marihuana product leaves the cultivator, except  
as provided in subrule (6) of this rule, a sample of the harvest batch must be tested for all  
required safety tests by a licensed laboratory as provided in R 420.304 and R 420.305. All test  
results must indicate passed in the statewide monitoring system before the marihuana is  
packaged for sale. A marihuana product from harvest batches mustmay not be transferred or  
sold until tested, packaged, and tagged as required under subrule (4) of this rule. A marihuana  
product from a harvest batch that fails safety testing may only be sold or transferred under the  
remediation protocol as provided in R 420.306.  
(6) A cultivator may transfer or sfresh frozen marihuana to a producer without first being  
tested by a laboratory in order to produce fsh frozen live resin, or if the marihuana product will  
be refined to a concentrate extracted, with agency approval. A cultivator may not transfer or  
sell marihuana to a producer under this rule if the package contains more than 1 harvest  
batch. This does not prohibit a cultivator from transferring multiple harvest batches for  
extraction. After the producer has processed extracted the material, the producer shall have the  
sample tested for all required safety tests pursuant to R 420.304 and R 420.305. A producer  
that received a package under this rule that has not been processed may transfer that  
package to another producer without having the package first tested by a laboratory to  
produce live resin or concentrate with agency approval. The agency may publish guidance  
for fresh frozen and concentrate production, transfer, and sale.  
(7) After test results show indicate a passed test for all required safety tests and the harvest  
batch is packaged, the cultivator shall destroy the individual plant tags. Eeach package must have  
a package tag attached. A cultivator shall ensure this information is placed in the statewide  
monitoring system in accordance with the acts, the marihuana tracking act, and these rules.  
(8) A cultivator shall not transfer or sell any marihuana product that has not been packaged with  
does not have a package tag attached and is not recorded in the statewide monitoring system in  
accordance with the acts, the marihuana tracking act, and these rules.  
5
(9) After a producer receives or purchases a package in the statewide monitoring system, and  
the producer proceeds to process the marihuana product in accordance with the scope of a  
producer license, the acts, and these rules, the producer shall give the marihuana product a new  
package tag anytime the marihuana product changes form or is incorporated into something else.  
(10) After a package is created by a producer of the marihuana product in its final form, the  
producer shall have the sample tested pursuant to R 420.304 and R 420.305. The producer shall  
not transfer or sell a marihuana product to a marihuana sales location until after test results  
entered into the statewide monitoring system indicate a passed test. Nothing in this subsection  
prohibits a producer from transferring or selling a package in accordance with the remediation  
protocol provided by the agency and these rules.  
(11) A marihuana sales location may sell or transfer marihuana product only to a marihuana  
customer under both of the following conditions:  
(a) The marihuana product has received passing test results in the statewide monitoring system.  
(b) The marihuana product bears the label required for retail sale, under the acts and these  
rules.  
R 420.303a Producer and sales location packaging and testing requirements.  
Rule 3a. (1) A producer shall give a marihuana product a new package tag anytime the  
marihuana product changes form or is incorporated into a different product.  
(2) A producer of a marihuana product in its final form shall have the sample tested  
pursuant to R 420.304 and R 420.305. The producer shall quarantine products from all  
other products when the product has test results pending. The producer shall not transfer  
or sell a marihuana product to a marihuana sales location until after test results entered  
into the statewide monitoring system indicate a passed result for all required safety tests.  
Nothing in this subsection prohibits a producer from transferring or selling a package in  
accordance with the remediation protocol provided by the agency and these rules.  
(3) A marihuana sales location may sell or transfer a marihuana product only to a  
marihuana customer under both of the following conditions:  
(a) The marihuana product has received passing results for all required safety tests in the  
statewide monitoring system.  
(b) The marihuana product bears the label required under the acts and these rules for  
retail sale.  
R. 420.304 Sampling; testing.  
Rule 4. (1) A laboratory shall test samples as provided in the acts and these rules.  
(2) A laboratory shall collect samples of a marihuana product from another marihuana business,  
and that marihuana business shall allow the collection of samples for testing, according to not  
interfere or prevent the laboratory from complying with all of the following requirements:  
(a) The laboratory shall physically collect the sample the marihuana product from another  
marihuana business to be tested at the laboratory. A laboratory shall comply with all the  
following:  
(i) The laboratory shall ensure that samples of the marihuana product are identified in the  
statewide monitoring system and placed in secured, sealed containers that bear the labeling  
required under these rules.  
6
(ii) The route plan and manifest must be entered into the statewide monitoring system, and a  
copy must be carried in the transporting vehicle and presented to a law enforcement officer upon  
request.  
(iii) The marihuana must be transported in 1 or more sealed containers and not be accessible  
while in transit.  
(iv) The vehicle a laboratory is using to transport samples of marihuana product must not bear  
markings or other indication that it is carrying marihuana or a marihuana-infused product.  
(b) Except otherwise required by the agency, the laboratory shall collect a sample size that is  
sufficient to complete all required analyses, anot less than 0.5% of the weight of the harvest  
batch. Prior to September 1, 2020, the maximum harvest batch size is 15 pounds. From  
September 1, 2020, through December 31, 2020, the maximum harvest batch size is 20 pounds.  
From January 1, 2021 through March 31, 2021, the maximum harvest batch is 25 pounds. After  
March 31, 2021, tThe maximum harvest batch is 50 pounds. At least 50% of the sample taken  
must be homogenized for testing. The agency may publish sample sizes for other marihuana  
products being tested. The laboratory must develop a statistically valid sampling method to  
collect a representative sample from each batch of marijuana product. The laboratory must have  
access to the entire batch for the purposes of sampling.  
(c) The maximum harvest batch is 50 pounds. At least 50% of the sample taken must be  
homogenized for testing. Te agency may publish sample sizes for marihuana products  
being tested.  
(d) The laboratory shall develop a statistically valid sampling method and have it  
approved by the agency to collect a representative sample from each batch of marihuana  
product. The laboratory shall have access to the entire batch for the purposes of sampling.  
(ce) An employee of the marihuana business from which marihuana product test samples are  
being taken collected shall be physically present to observe the laboratory employee collect the  
sample of marihuana product for testing and shall ensure that the sample increments are taken  
from throughout the batch.  
(df) An employee of a marihuana business shall neither assist the laboratory employee nor  
touch the marihuana product or the sampling equipment while the laboratory employee is  
obtaining the sample.  
(eg) After samples have been selected, both the employee of the marihuana business that had  
the samples collected and the employee from the laboratory shall sign and date the chain of  
custody form, attesting to the following sample information below:  
(i) Marihuana product name.  
(ii) Weight of marihuana product.  
(iii) All marihuana products and samples are correctly identified in the statewide monitoring  
system.  
(iv) If the product test sample is obtained for a retest, the laboratory confirms that it is not  
accepting a product test sample that is prohibited from being retested.  
(fh) The A marihuana business shall enter in the statewide monitoring system the marihuana  
product test sample that is collected by a licensed laboratory, including the date and time the  
marihuana product is collected and transferred. The laboratory shall enter into the statewide  
monitoring system the test results within 3 business days of test completion.  
(gi) If a testing sample is collected from a marihuana business for testing in the statewide  
monitoring system, that marihuana business shall quarantine the marihuana product that is  
undergoing the testing from any other marihuana product at the marihuana business. The  
7
quarantined marihuana product must may not be packaged, transferred, or sold until passing test  
results are entered into the statewide monitoring system.  
(hj) Any marihuana product that a laboratory collects for testing from a licensee under this rule  
must may not be transferred or sold to any other marihuana business other than the licensee from  
whom the sample was collected. This provision does not apply to a laboratory who that engages  
another laboratory to perform certain safety tests on a subcontracted basis.  
(ik) A laboratory may collect additional sample material from the same licensee from which  
the original sample was collected for the purposes of completing the required safety tests as long  
as the requirements of this rule are met.  
(jl) The agency may publish guidance that shall must be followed by marihuana businesses for  
chain of custody documentation.  
R. 420.305 Testing; laboratory requirements.  
Rule 5. (1) A laboratory shall do all of the following:  
(a) Bbecome fully accredited fall required safety tests in at least 1 required matrix to the  
International Organization for Standardization (ISO), ISO/IEC 17025:2017, by an International  
Laboratory Accreditation Cooperation (ILAC) recognized accreditation body or by an entity  
approved by the agency within 1 year after the date the laboratory license is issued and agree to  
have the inspections, and reports, and all scope documents of the International Organization for  
Standardization made available sent directly to the agency from the accrediting body.  
(b) Maintain internal standard operating procedures for the required safety tests in subrule (3)  
of this rule and for sampling of marihuana and marihuana products that conform to ISO/IEC  
17025:2017 standards and have been approved by the agency.  
(c) Maintain a quality control and quality assurance program that conforms to ISO/IEC  
17025:2017 standards and meets the requirements established by the agency.  
(2) A laboratory shall use analytical testing methodologies for the required safety tests in  
subrule (3) of this rule that are validated by an independent third party and may be monitored on  
an ongoing basis by the agency or a third party. In the absence of rerence to compendia or  
published, peer reviewed, validated cannabis methods, Appendix J or K of Official Methods  
of Analysis authored by the Association of Official Analytical Chemists Analytical  
Collaboration (AOAC) International must be published in full with guidance from published  
cannabis standard method performance requirements where available. The laboratory  
shall obtain approval from the agency of its validated methodology, including confirmation  
that it produces scientifically accurate results for each safety test, prior to conducting any  
safety testing. agency shall approve the validated methodology used by the laboratory and  
confirm that it produces scientifically accurate results for each safety test it conducts.  
(3) A laboratory shall conduct the required safety tests specified in subdivisions (a) to (i) of this  
subrule on marihuana product that is part of the harvest batch as specified in R 420.303, except  
as provided in subrule (4) of this rule. The agency may publish minimum testing portions to  
be used in compliance testing. After the testing on the harvest batch is completed, tThe agency  
may publish a guide indicating which of the following safety tests are required based on product  
type when the marihuana product has changed form:  
(a) Potency analysis. Potency analysis performed just as the marihuana product is without any  
corrective factor taken for moisture content that includes concentrations of the following:  
(i) Tetrahydrocannabinol (THC).  
8
(ii) Tetrahydrocannabinol acid (THC-A).  
(iii) Cannabidiol (CBD).  
(iv) Cannabidiol acid (CBD-A).  
(v) Additional cannabinoids, which may be tested with approval from the agency.  
i) In the preparation of samples intended for potency analysis, the laboratory may not  
adulterate or attempt to manipulate the total potency of the sample by adding trichomes  
that were removed during the grinding and homogenization process.  
(ii) All flower material used for potency testing must be representative of the product  
used by the end consumer and homogenized in such a way that it is representative of the  
way a consumer would be using the product. ef must not be reintroduced to the flower  
sample during the homogenization process.  
(iii) Potency analysis performed just as the marihuana product is whout any corrective  
factor taken for moisture content that includes concentrations of the following:  
(Total Tetrahydrocannabinol (THC).  
(B) Tetrahydrocannabinol acid (THC-A).  
(C) Total Cannabidiol (CBD).  
(D) Cannabidiol acid (CBD-A).  
(E) Additional cannabinoids, which may be tested with approval from the agency.  
(b) Inspection for Fforeign matter inspection including powdery mildew, organic, and  
inorganic material.  
(c) Microbial screening including an optimized incubation period for all non-molecular  
automated systems methods and all plating-based methods used to report quantitative total  
yeast and mold results.  
(d) Chemical residue testing that includes all of the following performed on the list of  
banned chemical residues and the required LOQs published by the agency.  
(i) Pesticides.  
(ii) Fungicides.  
(iii) Insecticides.  
(e) Heavy metals testing as required in this rule.  
(f) Residual solvents. The agency shall publish a list of required residual solvents to be tested  
for and their action limits.  
(g) Water activity.  
h) Under the medical marihuana facilities licensing act, mMycotoxin screening if requested by  
the agency. The agency shall publish a list of required mycotoxins to be tested.  
(i) Target analytes if requested by the agency. The agency shall publish a list of required target  
analytes to be tested for and their LOQs.  
(4) Amarihuana producers may become certified to GMP by an ISO 17065 accreditation  
body. This accreditation may enable the licensee certain allowances with testing. The agency  
will publish those allowances and information on how to obtain approval for allowances. The  
standard used for certification for GMP must be American National Standards Institute (ANSI)  
accredited or equivalent.  
(5) All marihuana cultivators may become certified to GACP-GMP by an accrediting body.  
This accreditation may enable the licensee certain allowances with testing. The agency will  
publish these allowances and information on how to obtain approval for allowances. The  
standard used for certification for GACP-GMP must be World Health Organization and  
American Herbal Products Association oequivalent.  
9
(6) Except as otherwise provided in R 420.306, if a sample collected pursuant to R 420.304 or  
provided to a laboratory pursuant to these rules does not pass the required safety tests, the  
marihuana business that provided the sample shall dispose of destroy the entire batch from  
which the sample was taken and document the disposal destruction of the sample using the  
statewide monitoring system pursuant to the acts and these rules within 90 calendar days.  
(7) A laboratory shall conduct residual solvent testing on batches of marihuana concentrates  
and marihuana-infused products. The agency shall publish a list of required residual solvents to  
be tested for and their action limits.  
(8) A laboratory shall maintain any marihuana samples for at least 30 calendar days after test  
completion and dispose of destroy the resulting waste in accordance with R 420.209.  
(9) Potency shall include the following cannabinoid concentrations listed in subdivisions (a) to  
(f) of this subrule, subject to subdivisions (g) and (h) of this subrule:  
(a) Total THC concentration.  
(b) THC-A concentration.  
c) Total THC, which includes Delta 7, Delta 8, Delta 9, Delta 10, and Delta 11 THC and  
THC-A. The following calculation must be used for calculating Total THC, where M is the mass  
or mass fraction of delta-9 THC or delta-9 THC-A:  
M total delta-9 THC = M delta-9 THC + 0.877 x M delta-9 THC-A. Σ Delta 7-11 THC + Σ  
((Delta 7-11 THCA) x 0.877)=Total THC  
(d) Total CBD concentration.  
(e) CBD-A concentration.  
(f) Total CBD. The following calculation must be used for calculating Total CBD, where M is  
the mass or mass fraction of CBD and CBD-A:  
M total CBD = M CBD + 0.877 x M CBD-A.  
(g) For marihuana and marihuana concentrates, total THC and total CBD must be reported in  
percentages.  
h) For marihuana infused products, potency must be reported as milligrams of Delta-9-THC  
and CBD in milligrams (mg) per serving under MRTMA and in milligrams (mg) per dose under  
MMFLA.  
(10) The agency shall publish a list of action limits for the required safety tests in subrule (3) of  
this rule, except for potency. A marihuana sample with a value that exceeds the published action  
limit is considered to be a failed sample. A marihuana sample that is at or below the action limit  
is considered to be a passing sample.  
(11) For the purposes of chemical residue testing and target analyte testing, the agency shall  
publish a list of quantification levels. Any result that exceeds the action limit is a failed sample.  
(12) If a sample provided to a laboratory pursuant to this rule and R 420.304 passes the safety  
tests required under subrule (3) of this rule, the laboratory shall enter the information in the  
statewide monitoring system of passed test results within 3 business days of test completion.  
Passed test results must be in the statewide monitoring system for a batch to be released for  
immediate processing, packaging, and labeling for transfer or sale in accordance with the acts  
and these rules.  
(13) A laboratory shall enter the results into the statewide monitoring system and file with the  
agency within 3 business days of test completion.  
(14) The agency shall establish a proficiency testing program and designate laboratory  
participation. All laboratories must shall participate in the proficiency testing program  
established by the agency. A laboratory shall analyze proficiency test samples from any ISO  
10  
17043 accredited vendor on an annual basis unless the agency requests additional testing.  
All testing must use using the same procedures with the same number of replicates analyses,  
standards, testing analysts, and equipment as used for marihuana product testing. A laboratory  
shall successfully analyze a 1 set of proficiency testing samples for all required analytes not  
less than annually. A laboratory shall have annual all proficiency testing results submitted  
directly to the agency from the proficiency testing vendor for review. The agency will not accept  
copies. All failed proficiency tests must include corrective action documentation and must be  
repeated until the laboratory obtains an additional acceptable result for all analytes  
proficiency test. Proficiency tests must be externally graded and results must be reported  
conveyed as numerically and not as pass or fail results for all quantitative methods. accuracy  
percentages, not simply as PASS/FAIL results. Actual PASS/FAIL results must be calculated  
based on accuracy thresholds generated by reproducibility studies specific to each assay.  
(15) The agency shall take immediate disciplinary action against any laboratory that falsifies  
records or does not comply with the provisions of this rule, including sanctions or fines, or both.  
(16) A laboratory shall not do any of the following:  
(a) Desiccate samples.  
(b) Pre-test samples.  
c) Cherry pick, which means testing specific material from a batch. All sample  
increments must have the same chances of being selected.  
(d) Manipulate samples in any way that would decrease or otherwise mask the amount of  
contaminant in the product.  
(17) A laboratory shall comply with random quality assurance compliance checks upon at the  
request of the agency. The agency or its authorized agents may collect a random sample of a  
marihuana product from a laboratory or designate another laboratory to collect a random sample  
of a marihuana product in a secure manner to test that sample for compliance pursuant to these  
rules.  
(18) A laboratory may perform terpene analysis on a marihuana product by a method approved  
by the agency, and the method must be accredited on the same frequency as all required  
safety tests. There are no established safety standards for this analysis.  
(19) A laboratory shall comply with investigations to ensure the health and safety of the public.  
At the request of the agency, a laboratory may be requested to perform testing as part of an  
investigation.  
(20) Under the medical marihuana facilities licensing act, tThe agency may request mycotoxin  
testing. A marihuana sample with a value that exceeds the published acceptable level is  
considered to be a failed sample. A marihuana sample that is below the acceptable value is  
considered to be a passing sample.  
(21) A laboratory shall have a policy or procedure in place for handling and reporting any  
potentially hazardous contaminants that may be encountered during routine testing. A  
laboratory shall notify the agency if a test batch is found to contain levels of a contaminant  
that could be injurious to human health.  
(22) Marihuana-infused products found to contain Salmonella spp. or Shiga toxin  
producing E. coli (STEC) must be reported to the agency immediately.  
R 420.305a Validations.  
11  
Rule 5a. (1) All validations must be submitted to the agency for approval with an  
acceptable proficiency test that meets the standards in R 420.305(14), where all required  
analytes are shown to have passed.  
(2) Laboratories shall use microbial testing methodologies for the required safety tests in  
R 420.305 that are validated by an independent third party and may be monitored on an  
ongoing basis by the agency. Ithe absence of published, peer reviewed, validated  
cannabis methods, Appendix J of Official Methods of Analysis authored by the Association  
of Official Analytical Collaboration must be published in full with guidance from the  
cannabis standard method performance requirements where available. The agency shall  
approve the validated methodology used by the laboratory and confirm that it produces  
scientifically accurate results for each safety test it conducts.  
(a) All validations must be submitted to the agency for approval with an acceptable and  
graded external proficiency test by a third party, where all required analytes are shown to  
have passed.  
b) Validation protocols should perform inoculation of marihuana matrices with live  
organisms where feasible to ensure that both extraction and detection for the assay are  
tested. To further test the accuracy of the assay, probability of detection (POD) analyses,  
inclusivity, exclusivity, lot-to-lot stability, and robustness studies must be included in the  
validation studies.  
(c) Methods adopted from a matrix specific standard method, inclusivity and exclusivity  
do not require a comprehensive reassessment, provided that there were no modifications to  
the methods, including, but not limited to, all of the following:  
i) Referenced media.  
(ii) Primers.  
(iii) Probes.  
(iv) Antibodies.  
(v) Critical chemistries that were not modified.  
(d) Microbial methods must include environmental monitoring and quality control of all  
buffers, media, primers, and incubators.  
R 420.305b Quality assurance and quality control.  
Rule 5b. (1) A laboratory must have a procedure for monitoring the validity of results.  
(2) This monitoring must occur on an ongoing basis and be reviewed by the laboratory  
manager. The monitoring must include all of the following:  
(a) Use of reference materials or quality control materials.  
(b) A functional check or checks of measuring and testing equipment.  
(c) Use of working standards and verification with control charts, where applicable.  
(d) Intermediate checks on measuring equipment.  
(e) Review of reported results.  
(f) Intra-laboratory comparisons, which involve proficiency testing.  
(3) A laboratory shall adhere to all required quality control procedures specified in the  
reference method or methods to ensure that routinely generated analytical data is  
scientifically valid and defensible and is of known and acceptable precision and accuracy.  
(4) A laboratory shall have a written quality assurance manual that includes, but is not  
limited to, all of the following items:  
12  
(a) Laboratory organization and responsibilities.  
(c) Field sampling procedures.  
(d) Instrument and equipment preventative maintenance and calibration procedures.  
(e) Data reduction, validation, reporting, and verification.  
(f) Identification of laboratory errors, customer complaints, and corrective actions.  
(5) A laboratory shall prepare a written description of its quality control activities,  
included as part of a quality control manual. All of the following items must be addressed  
in the quality control manual:  
(a) Daily, weekly, monthly, and annual requirements.  
(b) An analytical testing batch, which is defined as not more than 20 samples.  
(c) All analytical testing runs must be bracketed with quality controls.  
(6) Quality control acceptance criteria must be published by the agency and be followed.  
If the method acceptance criteria are more stringent, then the method acceptance criteria is  
required.  
(7) A laboratory shall have standard operating procedures for all sampling and testing  
performed.  
(8) All standard operating procedures for the required safety tests in R 420.305 and for  
sampling and testing of marihuana and marihuana products that conform to ISO/IEC  
17025:2017 standards, Good Laboratory Practices, shall be approved by the agency prior  
to the performance of any safety tests.  
(9) A laboratory shall maintain a quality control and quality assurance program that  
conforms to Good Laboratory Practices and ISO/IEC 17025:2017 standards and meets the  
requirements established by the agency.  
R 420.306 Testing marihuana product after failed initial safety testing and remediation.  
Rule 6. (1) A laboratory may test marihuana product that has failed initial safety testing, except  
as indicated under subrule (3) of this rule.  
(2) A failed marihuana product must pass 2 separate tests with new samples consecutively to be  
eligible to proceed to sale or transfer.  
) Products that failed testing for Aspergillus are ineligible for remediation.  
(34) The agency may publish a remediation protocol including, but not limited to, the sale or  
transfer of marihuana product after a failed safety test as provided in these rules.  
(45) Tmarihuana business that provided the sample is responsible for all costs involved in a  
retest.  
R 420.307 Research and development testing.  
Rule 7. (1) As used in this rule, “research and development testing” means optional testing  
performed before final compliance testing.  
(2) Except for R 420.304(2)(b), when performing research and development testing, the  
laboratory must comply with these rules.  
(3) Punitive action shall not be taken against a marihuana business for conducting research and  
development testing when permitted.  
(4) The agency may publish guidance for research and development testing that must be  
followed by all marihuana businesses.  
13  
(5) All research and development testing must be entered into the statewide monitoring system.  
(6) Marihuana that has undergone only research and development testing is not eligible for  
transfer by a cultivator to a producer under the allowances listed in R 420.303(6).  
) Research and development testing is prohibited after compliance testing has been  
completed.  
Robin Schneider  
MiCIA  
Executive Director  
(517) 974-2265  
101 S. Washington Square #820  
Lansing, MI 48933  
robin@micannabisindustryassociation.org  
micannabisindustryassociation.org  
MICIA COMMENTS ON DRAFT MARIHUANA RULES  
(Rule Sets # 2021-29 LR, 2020-117 LR, 2020-118 LR, 2020-119 LR, 2020-120 LR, 2020-121  
LR, 2020-122 LR, 2020-123 LR, and 2020-124 LR)  
INTRODUCTION  
The Michigan Cannabis Industry Association (MICIA) is the leading voice for Michigan’s  
legal cannabis businesses. The association advocates for a responsible and successful medical and  
adult-use cannabis industry by promoting sensible laws and regulations and industry best practices  
among members. MICIA seeks to create a thriving industry for cannabis businesses in Michigan  
by developing opportunities for industry collaboration and partnerships and sharing industry  
knowledge and best practices among its membership.  
MICIA supports many elements of the proposed rules. But MICIA offers the following  
constructive comments with the hopes of developing policies that promote both the growth of the  
industry and the establishment of good business practices. Moreover, MICIA seeks to ensure that  
the Marijuana Regulatory Agency (MRA) receives adequate stakeholder input prior to the  
adoption of its generally applicable policies, standards, and enforcement procedures consistent  
with the rule of law and the Michigan Administrative Procedures Act, MCL 24.201 et seq. Lastly,  
MICIA notes that, though it has not exhaustively commented on all of the rules, its silence on some  
rules should not be understood as either approval or disapproval of those particular provisions.  
COMMENTS  
I.  
RULE SET 2021-29 LR (DECLARATORY RULINGS, R. 420.821 ET SEQ.)  
Proposed Rules 420.821 through 420.823 create a procedure through which the MRA may  
issue declaratory rulings as to the applicability to an actual state of facts of a statute, rule, final  
order, or decision administered, promulgated, or issued by the agency. The MICIA supports the  
MRA’s efforts to promulgate rules outlining the declaratory rulings process and offers the  
following industry feedback on how those proposed rules may be improved.  
The MRA’s Legal Authority for Declaratory Rulings Derives from the APA  
The MRA asserts that its legal authority for this Proposed Rule Set is conferred by “section  
5 of the Michigan Medical Marihuana Act, 2008 IL 1, MCL 333.26425, section 206 of the medical  
marihuana facilities licensing act, 2016 PA 281, MCL 333.27206, sections 7 and 8 of the Michigan  
ClarkHill\98902\346090\264189386.v2-9/26/21  
Regulation and Taxation of Marihuana Act, 2018 IL 1, MCL 333.27957 and 333.27958, and  
Executive Reorganization Order No. 2019-2, MCL 333.27001).”  
None of those statutes expressly confer on the MRA the authority to issue declaratory  
rulings or issue rules setting the procedure for same. Rather, Section 63 of the Administrative  
Procedures Act provides the MRA the authority to prescribe the form and procedure for declaratory  
ruling requests, submissions, consideration, and disposition by administrative rule. MCL 24.263.  
Specifically, Section 63 states:  
On request of an interested person, an agency may issue a declaratory ruling as to  
the applicability to an actual state of facts of a statute administered by the agency  
or of a rule or order of the agency. An agency shall prescribe by rule the form for  
such a request and procedure for its submission, consideration and disposition. A  
declaratory ruling is binding on the agency and the person requesting it unless it is  
altered or set aside by any court. An agency may not retroactively change a  
declaratory ruling, but nothing in this subsection prevents an agency from  
prospectively changing a declaratory ruling. A declaratory ruling is subject to  
judicial review in the same manner as an agency final decision or order in a  
contested case.  
As such, the boilerplate “authority” language at the outset of the Proposed Rule should be amended  
to reference Section 63 of the APA.  
The MRA’s Process Timing is Too Long  
Proposed Rule 420.822 affords the MRA 60 days to issue notification to a party seeking a  
declaratory ruling as to whether the MRA will issue a declaratory ruling and, if so, another 90 days  
to issue the ruling “unless the agency notifies the interested person in writing of the need for  
additional time, and the reasons for the additional time.” Consequently, the Proposed Rule would  
provide the MRA 150 days to issue a declaratory ruling unless the MRA decides to take longer for  
whatever written reason.  
The 150-day window with the potential to be extended further is outside of the standard  
time frame for a declaratory ruling and inconsistent with best practices. See, e.g., Mich Admin  
Code, R 324.81(2)(b) (requiring EGLE declaratory ruling to be issue “[w]ithin 60 days of receipt  
of the request” unless additional information is required); MCL 169.215(2) (requiring SOS to issue  
a ruling “within 60 business days after a request . . . is received”); Mich Admin Code, R 400.951  
(requiring MDHHS ruling “within 60 working days”); Mich Admin Code, R 436.1973(2)(f)  
(requiring Liquor Control Commission ruling “within 90 days after the receipt of the initial  
request.”). Therefore, the MICIA requests that the MRA consider shortening these timeframes to  
45 days and 60 days, respectively, and, rather than grant itself the discretion of unlimited extension,  
provide that: “A person requesting a declaratory ruling may waive, in writing, the time limitations  
provided by this section.” Timing is often a critical component of regulatory certainty and a more  
expedited process similar to those employed by other state agencies would better accomplish that  
objective.  
2
ClarkHill\98902\346090\264189386.v2-9/26/21  
There is a Lack of Public Transparency and Industry Participation  
The declaratory ruling process outlined by the Proposed Rules lacks transparency and  
precludes industry participation. For example, Proposed Rule 420.822(5) provides, in part, that:  
Before the issuance of the declaratory ruling, the agency, in its discretion, may  
choose to do 1 or more of the following: (a) Seek consultation, comments, or advice  
from legal counsel, experts within or outside the agency, local, state, or federal  
governmental agencies, or any other source. (b) Request information or  
clarification from other interested parties. (c) Advise the person requesting the  
ruling that further clarification of the facts must be provided, or that the agency  
requires additional time to conduct a review.  
But the Proposed Rule neither provides for public notification of a declaratory ruling request nor  
for participation of interested parties in a declaratory ruling request.  
Here, as well, the best practice includes the opportunity for interested persons other than  
the requestor to participate. See, e.g., MCL 169.215(2) (allowing interested members of the public  
to comment); Mich Admin Code, R 432.1715(2)(b) (considering “information from other  
interested persons”). Accordingly, the MICIA asks that the MRA consider amending the Proposed  
Rule to require the MRA to timely make declaratory ruling requests and decisions open to public  
view and to further allow for interested persons to submit comments regarding declaratory ruling  
requests. To accomplish that objective, the MRA could amend the Proposed Rule 420.822(5) to  
provide that:  
A request for a declaratory ruling that is submitted to the agency will be made  
available on its website for public inspection within 48 hours after its receipt. An  
interested person may submit written comments regarding the request to the agency  
within 10 business days after the date the request is made available to the public.  
The agency’s notification to a party seeking a declaratory ruling as to whether the  
MRA will issue a declaratory ruling will be made available on its website for public  
inspection at the time it is issued. If the agency’s notification provides that the  
agency will issue a declaratory ruling, an interested person may submit written  
comments regarding the subject matter of the declaratory ruling request to the  
agency within 10 business days after the notification is made available to the public.  
The MICIA further asks that the agency amend the Proposed Rule to provide that “The agency  
will make available to the public an annual summary of the declaratory rulings issued under this  
rule.” This added transparency and participation will aid the MRA in its mission and lead to more  
well-informed decision-making. An assessible compendium of declaratory rulings will also  
facilitate the compliance of licensees with applicable laws.  
The Substantive Scope of Review is Too Limited  
Proposed Rule 420.822(9) provides that “[r]equests regarding enforcement issues are not  
a proper subject for a declaratory ruling.” The MICIA asks that the MRA consider deleting or  
3
ClarkHill\98902\346090\264189386.v2-9/26/21  
altering this Proposed Rule for reason that it unnecessarily narrows the scope of subjects on which  
the agency may provide clarity. By its very nature, as a regulatory agency charged with enforcing  
the law, a wide swath of the issues that come before the MRA could properly be characterized as  
“enforcement issues.” The intent of an agency declaratory ruling, like a declaratory judgment  
action within the judiciary, is to provide clarity to affected persons “in order to guide or direct  
future conduct . . . .” Cf. UAW v Central Michigan University Trustees, 295 Mich App 486, 495;  
815 NW2d 132 (2012). Nowhere is such guidance more crucial than with respect to controversial  
matters, where enforcement may become an issue. Further, by limiting the scope of matters that  
may be addressed by declaratory ruling in this manner, the Proposed rule is far narrower than the  
controlling statute. MCL 24.263. As an alternative, MRA may consider rewriting Proposed Rule  
420.822(9) to clarify only that a matter that has already been referred for enforcement cannot be  
submitted by that licensee for a declaratory ruling.  
There is Judicial Review of Declaratory Rulings  
Proposed Rule 420.822(8) provides that “[a] denial or adverse decision of a declaratory  
ruling does not entitle a person to a contested case hearing.” This statement may have the  
inadvertent effect of chilling a licensee’s exercise of the right to appeal MRA’s decision on a  
declaratory ruling. For purposes of clarity, the MRA should consider adding additional language  
acknowledging that, under Section 63 of the Administrative Procedures Act, “[a] declaratory  
ruling is subject to judicial review in the same manner as an agency final decision or order in a  
contested case.” The MRA should further provide that its decision not to issue a declaratory ruling  
is subject to judicial review. See Human Rights Party v. Michigan Corrections Commission, 76  
Mich App 204; 256 NW2d 439 (1977) (“[W]e find that a refusal to issue a declaratory ruling under  
M.C.L.A. s 24.263 is subject to judicial review as an agency final decision or order in a contested  
case”).  
II.  
RULE SET 2020-117 LR (DISCIPLINARY PROCEEDINGS, R. 420.801 ET SEQ.)  
This Proposed Rule Set seeks to amend portions of Rule 420.801 through Rule 420.808 to  
clarify and/or strengthen the MRA’s disciplinary processes and notification/reporting  
requirements. The Proposed Rule Set also seeks to add a new Rule 420.808a which sets forth the  
grounds on which, and processes by which, the MRA may exclude a person from employment or  
participation in a marihuana business. The MICIA supports the MRA’s efforts to clarify and/or  
strengthen its disciplinary processes and further agrees with the MRA that clear and transparent  
disciplinary rules facilitate regulatory compliance and the protection of the public health and  
safety. The MICIA does, however, highlight that these proposed changes will increase licensee  
costs and liability but a detailed cost-benefit analysis has not been provided as required by MCL  
24.245(3)(h), (3)(k), (3)(l), (3)(n), (3)(p), (3)(q)–(3)(t), & (3)(bb). The MICIA further offers  
industry feedback on how those Proposed Rules may be improved.  
Grounds for Exclusion of Employment or Participation in a Marihuana Business  
Proposed Rule 420.808a(1)(a)–(1)(f) sets for the grounds on which the MRA may, in its  
discretion and pursuant to a contested case hearing if requested, exclude a person from  
employment at, or participation in, a marihuana business. The MICIA generally supports the stated  
grounds for exclusion with the exception that a previous finding of ineligibility for licensure, as  
4
ClarkHill\98902\346090\264189386.v2-9/26/21  
stated in Rule 420.808a(1)(c), alone is not a proper basis for exclusion of employment where the  
standard for holding a license is and should be higher than the standard for general employment.  
Contents of Notice of Exclusion  
Proposed Rule 420.808a(2) sets forth the contents of a notice of exclusion filed by the  
agency including “(a) The identity of the subject. (b) The nature and scope of the circumstances  
or reasons that the person should be placed on the exclusion list. (c) A recommendation as to  
whether the exclusion or ejection is permanent.” The MICIA supports these general contents for a  
notice of exclusion but submits that the MRA should also provide to the charged person “a detailed  
factual statement of the alleged grounds for exclusion accompanied by any supporting  
documentation or witness statements.”  
Proposed Rule 420.808a(3) states that “[t]he notice shall also inform the person of the  
availability of a hearing in compliance with R 420.705.” In light of Proposed Rule Set 2020-118  
LR, the MICIA queries whether the proper citation here is R. 420.704a which will address the  
hearing process for notices of exclusion.  
Service of Notice of Exclusion  
Proposed Rule 420.808a(2) provides that the MRA “shall file a notice of exclusion.” It is  
unclear what the term “file” in this context means, and the MICIA submits that the notice of  
exclusion should be personally served on both the person being excluded and, if applicable, the  
licensee employing that person.  
Proposed Rule 420.808a(6) provides that “[t]he exclusion list must be a public record made  
available to licensees by the agency and must include information deemed necessary by the agency  
to facilitate identification of the person placed on the exclusion list.” The MICIA submits that the  
phrase “made available to licensees” lacks detail and that, in light of the resulting disciplinary  
proceedings that result from employing a person on the exclusion list, the exclusion list should be  
periodically mailed to licensees, included into the statewide monitoring system, and/or posted on  
the agency’s website. Making this requested change would additionally add clarity to the phrase  
“knows or reasonably should know is on the exclusion list” in Proposed Rules 420.808a(8),(9).  
Due-Process Concerns Regarding Exclusion List  
Proposed Rule 420.808a(4) states that “[i]f a hearing is not requested, then the subject’s  
name or excluded person’s name must remain on the exclusion list.” Proposed Rule 420.808a(7)  
further clarifies the MRA’s intention and provides that “[a] person who is placed on the exclusion  
list or served with a notice of exclusion is prohibited from being employed by or participating in a  
marihuana business until a determination by the agency or a court to the contrary.”  
The MICIA acknowledges that there may, at times, exist unique circumstances where a  
person’s continued involvement in a marihuana business presents an immediate threat to the public  
health and safety and, in those circumstances, immediate placement on the exclusion list may be  
warranted. However, aside from an immediate threat to public health and safety, the MRA should  
5
ClarkHill\98902\346090\264189386.v2-9/26/21  
provide basic a higher level of due process to the charged person and that person’s placement on  
the exclusion list should occur until after that person has been afforded a hearing pursuant to R.  
420.704a.  
Notification and Reporting – Material Changes  
Proposed Rule 420.802(3) requires reporting of proposed material changes to a marihuana  
business and delineates several examples of what constitute a proposed material change. In an  
apparent effort to further clarify what constitutes a “proposed material change,” the agency now  
provides that “[a] proposed material change is any action that would result in alterations or changes  
being made to the marihuana business to effectuate the desired outcome of a material change.”  
The MICIA submits that this clarifying language is unnecessary and overbroad and requests that  
it be removed or narrowed.  
Notification and Reporting – Third-Party Violations  
Proposed Rule 420.802(4)(c) requires reporting, within 1 business day, of any “[a]ction by  
another party in actual or alleged violation of the acts or these rules.” Proposed Rule 420.801(e)  
defines “[a]nother party” or “other party” as “an individual or company with which a licensee  
contracts to use the individual or company’s intellectual property or to utilize management or other  
services provided by the individual or company.” The Proposed Rule, which is accompanied by  
disciplinary action for failure to report, places licensees in an quasi-enforcement role that is  
unreasonably impracticable and could potentially subject licensees to substantial costs and liability  
including, but not limited to, third-party litigation for defamation and other claims. The MICIA  
requests that this aspect of the Proposed Rule be removed or narrowed.  
Notification and Reporting – Licensing and Management Agreements  
Proposed Rule 420.802(7) provides that “[t]he licensee shall notify the agency within 10  
business days of terminating a licensing, management, or other agreement.” Proposed Rule  
420.801(i) defines “[l]icensing agreement” as “any understanding or contract concerning the  
licensing of intellectual property between a licensee and another party.” And, Proposed Rule  
420.801(j) defines “[m]anagement or other agreement” as “any understanding or contract between  
a licensee and another party for the provision of management or other services that would allow  
the other party to exercise control over or participate in the management of the licensee or to  
receive more than 10% of the gross or net profit from the licensee during any full or partial calendar  
or fiscal year.”  
The MICIA opposes these notification requirements and submits that the agency appears  
to lack statutory and/or rulemaking authority for this expansion of the notification and reporting  
requirements, which strictly construed are unreasonably impracticable. The MRA has not  
articulated a rational basis on which it may justify its exercise of regulatory authority over  
“licensing agreements” of intellectual property. Moreover, the term “Management or other  
agreement” is overbroad and cuts against the agency’s proposed definition of “employee” which  
excludes trade or professional services. At a minimum, if the MRA persists with its notification  
requirements with respect to management agreements, MICIA asks that the agency consider  
6
ClarkHill\98902\346090\264189386.v2-9/26/21  
revising the definition of “management agreement” to mean “any contract between a licensee and  
another party for the provision of management services that allows the other party to exercise  
control over or participate in the management of the licensee.” Such a definition would more fairly  
mirror the statutory term “managerial employee” under MCL 333.27102(c).  
Definition of Employee  
Proposed Rule 420.801(h) defines “Employee” as “a person performing work or service  
for compensation” but “does not include a person providing trade or professional services who is  
not normally engaged in the operation of a marihuana business.” The MICIA supports this  
common-sense clarification.  
III.  
RULE SET 2020-118 LR (HEARINGS, R. 420.701 ET SEQ.)  
This Proposed Rule Set seeks to amend portions of Rule 420.701 through Rule 420.706 to  
clarify and/or strengthen the MRA’s hearing processes and to add a new Rule 420.704a which sets  
forth a hearing process by which a person may challenge the agency’s decision to exclude the  
person from employment or participation in a marihuana business. The MICIA supports, without  
exception, the MRA’s Proposed Rules for hearings.  
IV.  
RULE SET 2021-10 LR (EMPLOYEES, R. 420.601 ET SEQ.)  
This Proposed Rule Set seeks to amend portions of Rule 420.601 through Rule 420.602 to  
strengthen the MRA’s requirements for, inter alia, employee training manuals and operational  
plans. The Proposed Rule Set also seeks to add a new Rule 420.602a that, inter alia, restricts  
employees of a cultivator, producer, marihuana sales location, or microbusiness from also being  
employed by a laboratory or transporter. The MICIA generally supports this Proposed Rules Set  
and agrees that the changes will facilitate consistency in the hiring and employment practices of  
marihuana businesses. The MICIA, however, disagrees with the agency’s assertion that these  
changes will not increase compliance costs and submits that the agency’s cost-benefit analysis is  
deficient. See MCL 24.245(3)(h), (3)(k), (3)(l), (3)(n), (3)(p), (3)(q)–(3)(t), & (3)(bb). In  
particular, MCL 24.245(3)(bb) requires that the MRA identify “the sources the agency relied on  
in compiling the regulatory impact statement, including the methodology used in determining the  
existence and extent of the impact of a proposed rule and a cost-benefit analysis of the proposed  
rule.” This has not been done.  
V.  
RULE SET 2020-119 LR (MARIHUANA-INFUSED PRODUCTS AND EDIBLE  
MARIHUANA PRODUCTS, R. 420.401 ET SEQ.)  
This Proposed Rule Set seeks to amend portions of Rule 420.401 through Rule 420.403 to  
continue to refine and make consistent requirements for infused and edible marihuana product to  
ensure safe handling, production, and labeling. The Rule Set also seeks to update standards  
referenced for the handling and production of these products. The MICIA’s supporting and  
opposing comments are below.  
7
ClarkHill\98902\346090\264189386.v2-9/26/21  
Product Labeling Requirements  
Proposed Rule 420.403(2) provides that “[m]arihuana-infused products processed under  
these rules must be homogenous” and that “[t]he allowable variation for weight and THC and CBD  
concentrations between the actual results and the intended serving is to be + or – 15%.” The MICIA  
submits that the labeling, homogeneity, and testing variance percentages should be consistent.  
Proposed Rule 420.403(7)(a) requires that producers label all marihuana-infused products  
with not only the name of the product but also that “[t]he name of the product must be an  
appropriately descriptive phrase that accurately describes the basic nature of the product.” The  
MICIA supports the agency’s labeling requirements but takes issue with the language  
“appropriately descriptive” for reason that it is vague. The MICIA recommends that the sentence  
read: “[t]he name of the product must accurately describe the basic nature of the product.”  
Proposed Rule 420.403(7)(b) requires that producers label all marihuana-infused products  
with not only the ingredients of the product but also the “component ingredients.” MICIA  
highlights that the term “component ingredients” is undefined and finds the term to be somewhat  
vague in application. The MICIA suggests that the agency consider striking the term and replacing  
it with the term “excipients.”  
Proposed Rule 420.403(7)(e) requires that producers label all marihuana-infused products  
with “[t]he date of the marihuana product was produced.” The MICIA supports this common-sense  
requirement.  
Proposed Rule 420.403(9)(b)-(e) clarifies product and labelling requirements to ensure that  
edible marihuana products are not confused with commercially available food products or  
attractive to children. The MICIA supports these clarifications but requests that the agency develop  
additional guidance and/or establish a process for issuing timely labelling approvals.  
Proposed Rule 420.403(10)(a) clarifies how producers are to set expiration dates for edible  
marihuana products and further provides that on the label that the product must be destroyed after  
the expiration date. The MICIA supports these changes but submits that the term “marihuana  
product” in this section should read “edible marihuana product.”  
Inflexible Product Storage Temperature Mandate  
Proposed Rule 420.403(8)(a) requires that producers of edible marihuana products comply  
with “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative  
Controls for Human Food, 21 CFR part 117” but that “[a]ny potentially hazardous ingredients used  
to process shelf-stable edible marihuana products must be stored at 40 degrees Fahrenheit, 4.4  
degrees Celsius, or below.”  
The MICIA supports application of the federal reference but asserts that the agency’s  
specific storage temperature requirement for hazardous ingredients should be stricken because it  
is not appropriate in all contexts and not necessarily consistent with the federal reference. See 21  
CFR § 117.80(5). Specifically, the specific storage temperature requirement in R. 420.403(8)(a)  
8
ClarkHill\98902\346090\264189386.v2-9/26/21  
requires what is defined in 21 CFR § 117.135 as a “Preventive Control,” without offering a licensee  
the opportunity to conduct a proper Hazard Analysis according to 21 CFR § 117.130 to see if a  
Preventive Control is warranted. Further, the specific storage temperature requirement in R.  
420.403(8)(a) applies this Preventive Control to an undefined sub-category of ingredients  
(“potentially hazardous ingredients used to process shelf-stable edible marijuana products”)  
without identifying the critical product attribute that is affected by storage temperature.  
Recordkeeping  
Proposed Rule 420.403(8)(b) requires that producers of edible marihuana products keep  
formulation records which, inter alia, include “test results for all ingredients used.” The MICIA  
suggests that because testing is not required for non-active/excipient ingredients, the Proposed  
Rule is overbroad and should be appropriately narrowed.  
VI.  
RULE SET 2020-120 LR (LICENSING, R. 420.101 ET SEQ.)  
This Proposed Rule Set seeks to amend portions of Rule 420.101 through Rule 420.11 to  
prohibit and authorize the purchase of caregiver product depending on licensee type; prohibit  
certain intra-license product transfers; authorize the provision of marihuana testing for non-  
licensee adults; and maintain laboratory accreditation exceptions. The Proposed Rule Set also adds  
a new Rule 420.105a which regulates Class A marihuana microbusiness licenses and a new Rule  
420.112a which regulates licensing and management agreements. The MICIA’s comments are  
below.  
Caregiver Product Transfers  
Proposed Rule 420.102(12) provides that “[a] marihuana grower [licensed under MRTMA]  
may not purchase or accept the transfer of a mature plant from an individual, registered qualifying  
patient, or registered primary caregiver.” Proposed Rule 420.105(8) contains the same prohibition  
with respect to microbusinesses licensed under MRTMA. Proposed Rule 420.108(10) contains the  
same prohibition with respect to growers licensed under the MMFLA.  
The MICIA does not take a position on whether grower licensees should be permitted to  
purchase or accept mature plants from registered qualifying patients or caregivers but submits that  
the various grower license types should be treated uniformly.  
Intra-license Transfers  
Proposed Rules 420.103(3) and 420.104(4), delete language authorizing marihuana  
processors and retailers, respectively, with two or more licenses at different establishments from  
transferring inventory between licensed establishments owned by the licensee.  
The MICIA opposes this change for reason that such transfers between licensed locations  
promote flexibility and help prevent product waste. Moreover, these proposed changes will  
increase licensee costs and a detailed cost benefit analysis has not been provided.  
9
ClarkHill\98902\346090\264189386.v2-9/26/21  
Class A Microbusinesses  
Proposed Rule 420.105a generally sets forth the rights and obligations of a Class A  
marihuana microbusiness license including, inter alia, the cultivation of not more than 300 mature  
plants, packaging of marihuana, purchasing of marihuana concentrate and infused products, sale  
of marihuana and marihuana products, and the purchase of seeds, tissue cultures, clones or  
marijuana plants from licensed growers.  
The MICIA supports these aspects of the Proposed Rules. However, Proposed Rule  
420.105a(8) specifically authorizes such license holders to “purchase or accept a mature plant from  
an individual, registered qualifying patient, or registered primary caregiver.” The MICIA does not  
take a position on whether grower licensees should be permitted to purchase or accept mature  
plants from registered qualifying patients or caregivers but submits that the various grower license  
types should be treated uniformly.  
Adult Marihuana Testing Services  
Proposed Rule 420.107(1)(c) provides that a marihuana safety compliance facility license  
authorizes the marihuana safety compliance facility to “Receive marihuana from and test  
marihuana for an individual 21 years of age or older, if the marihuana was produced by the  
individual and not purchased or obtained from a licensed marihuana business. The marihuana  
safety compliance facility shall keep documentation for proof of age.”  
The MICIA asks that the phrase “if the marihuana was produced by the individual and not  
purchased or obtained from a licensed marihuana business” be stricken. The MICIA’s position is  
that an adult in legal possession of marijuana should not be limited with respect to testing services  
based upon the legal source of the marijuana. Any adult should have access to product safety  
testing if they are concerned about the product for any reason, without limitation. When a sample  
is presented to a lab for testing that was obtained from a licensed business, the chain of custody  
will be broken on the sample and results cannot be used to represent batch quality. This makes the  
proposed limiting language unnecessary. Moreover, if a sample is presented to a lab for testing by  
an adult, the lab has no way of definitively verifying its source, and neither does the MRA. This  
renders the rule practically unenforceable.  
Laboratory Accreditation Exceptions are no Longer Needed  
Proposed Rule 420.107(2)(c) and 420.112(2) provide that “[a] safety compliance facility  
must be accredited by an entity approved by the agency by 1 year after the date the license is issued  
or have previously provided drug testing services to this state or this state’s court system and be a  
vendor in good standing in regard to those services” that “the agency may grant a variance from  
this requirement upon a finding that the variance is necessary to protect and preserve the public  
health, safety, or welfare.”  
The MICIA submits that these provisions should be amended to read only that “[a]  
marijuana safety compliance facility must be accredited by an entity approved by the agency prior  
to issuance of a state operating license.” Accreditation protects public health and safety and there  
10  
ClarkHill\98902\346090\264189386.v2-9/26/21  
is no longer any need for post-licensure accreditation nor the issuance of variances for  
accreditation. When the MRA was established in 2018, only four labs were operating in the state,  
and thus good cause existed for these exceptions to accreditation. Now, almost three years later,  
with fifteen licensed and operating testing laboratories, there is no need for the lower bar.  
Accreditation ensures that a laboratory has a functional quality system, complete with validated  
test methods, to ensure the accuracy of published test results.  
Plant Count for MMFLA Grower  
Proposed Rule 420.108(2) provides that “[f]or the purposes of this rule, a marihuana plant  
that meets the definition of a plant in the MMFLA is included in the plant count in subrule (1) of  
this rule.” The MMFLA, however, defines the term “marihuana plant” and “plant” and it is unclear  
to which term the agency refers in this language. The MICIA submits that the term “marihuana  
plant” is the correct term.  
Regulation of Licensing and Management Agreements  
Proposed Rule 420.112a creates a new regulatory regime whereby the MRA seeks to  
require all “licensing agreements”1 and “management agreements”2 of a marihuana licensee to be  
submitted to the MRA for review and approval prior to performance thereunder and further  
requires those agreements to specify a litany of detailed contractual terms relating to payment,  
services, performance, and merger. The Proposed Rule 420.112a(4) further delineates a non-  
exclusive set of contract terms that would render the non-licensed party subject to the agency’s  
application requirements including: “[a]ny term or condition that would allow the other party to  
receive more than 10% of the gross or net profit from the licensee during any full or partial calendar  
or fiscal year” and “[a]ny term or condition that would require the licensee to name the other party  
as a named insured on any insurance policy required to be maintained as a condition of a marihuana  
license.”  
The MICIA opposes these new filing and approval requirements and submits that the  
agency appears to lack statutory and/or rulemaking authority for this expansion of government  
regulation, which strictly construed is unreasonably impracticable, and which may retroactively  
impair contracts. These proposed changes will also increase licensee costs and a detailed cost  
benefit analysis has not been provided. The MRA has not articulated a rational basis on which it  
1
Proposed Rule 420.101(l) defines “licensing agreement” as “any understanding or contract  
concerning the licensing of intellectual property between a licensee and another party.” Proposed  
Rule 420.101(k) defines “intellectual property” as “all original data, findings, or other products of  
the mind or intellect commonly associated with claims, interests, and rights that are protected  
under trade secret, patent, trademark, copyright, or unfair competition law and includes brands or  
recipes.”  
2 Proposed Rule 420.101(m) defines “management or other agreement” as “any understanding or  
contract between a licensee and another party for the provision of management or other services  
that would allow the other party to exercise control over or participate in the management of the  
licensee or to receive more than 10% of the gross or net profit from the licensee during any full or  
partial calendar or fiscal year.”  
11  
ClarkHill\98902\346090\264189386.v2-9/26/21  
may justify its exercise of regulatory authority over “licensing agreements” of intellectual  
property. Moreover, the term “Management or other agreement” is overbroad and cuts against the  
agency’s proposed definition of “employee” which excludes trade or professional services. At a  
minimum, if the MRA persists with its filing and approval requirements with respect to  
management agreements, MICIA asks that the agency consider revising the definition of  
“management agreement” to mean “any contract between a licensee and another party for the  
provision of management services that allows the other party to exercise control over or participate  
in the management of the licensee.” Such a definition, albeit broader than the statute, would more  
fairly mirror the statutory term “managerial employee” under MCL 333.27102(c).  
VII. RULE SET 2020-121 LR (LICENSING, R. 420.1 ET SEQ.)  
This Proposed Rule Set seeks to amend portions of Rule 420.1 through Rule 420.27 to,  
inter alia, provide for administrative withdrawals of license applications; expand applicant  
disclosure requirements; disclaim vested rights in licenses; lower and streamline renewal  
application fees; and continue to utilize moral character in licensure determination. The Proposed  
Rule Set also adds a new Rule 420.27a also creates a new class of regulated marihuana educational  
research licenses. The MICIA’s comments are below.  
Administrative Application Withdrawal  
Proposed Rules 420.3(3) and (6) authorize the MRA to withdraw applications for  
prequalification and licensure and force applicants to reapply in instances where an application  
has been pending for over one year. Proposed Rule 420.3(7) further provides that “[t]he agency  
may administratively withdraw an amendment to any application or marihuana license if the  
applicant or licensee fails to respond or submit documentation to cure all deficiencies within 30  
days after notice of the deficiency.”  
The MICIA opposes these changes for reason that they are patently unfair. Applicants  
should not be forced to reapply and/or pay additional licensure fees where, through no fault of  
their own, the MRA has failed to adjudicate a license application in under one year. Moreover, 60  
days would be a more reasonable timeframe in which applicants may cure deficiencies.  
Expanded Application Disclosure Requirements  
Proposed Rule 420.4(3) deletes language providing that “[e]ach applicant shall disclose all  
shareholders holding a direct or indirect interest of greater than 5%, officers, and directors in the  
proposed marihuana establishment” and adds language providing that “[e]ach applicant shall  
disclose the identity of every person having a 2.5% or greater ownership interest in the applicant  
with respect to which the license is sought. (a) If the disclosed entity is a trust, the applicant shall  
disclose the names and addresses of the beneficiaries. (b) If the disclosed entity is a privately held  
corporation, the names and addresses of all shareholders, officers, and directors. (c) If the disclosed  
entity is a publicly held corporation, the names and addresses of all shareholders holding a direct  
or indirect interest of greater than 5%, officers, and directors. (d) If the disclosed entity is a  
partnership or limited liability partnership, the names and addresses of all partners. (e) If the  
disclosed entity is a limited partnership or limited liability limited partnership, the names of all  
12  
ClarkHill\98902\346090\264189386.v2-9/26/21  
partners, both general and limited. (f) If the disclosed entity is a limited liability company, the  
names and addresses of all members and managers.”  
The MICIA opposes this more stringent disclosure requirement for a de minimis ownership  
interest. It is unnecessary, will jeopardize licensee funding, is unreasonably impracticable, and  
may retroactively impair contracts. The MICIA further submits that the agency appears to lack  
statutory and/or rulemaking authority for this expansion of the disclosure requirement beyond the  
bounds of MCL 333.27102. These proposed changes will also increase licensee costs and a  
detailed cost benefit analysis has not been provided. The MRA has also failed to articulate a  
rational basis on which it may justify its increased disclosure requirements.  
Vested Rights in Marihuana License  
Proposed Rule 420.6(6) asserts that “[a] marihuana license is a revocable privilege granted  
by the agency and is not a property right” and that “[g]ranting a marihuana license does not create  
or vest any right, title, franchise, or other property interest.”  
The MICIA acknowledges that this language tracks and then expands on the language  
provided that MCL 333.27409. Nonetheless, the MICIA opposes this language for the reason that  
it may be legally incorrect where a license has been issued, substantial investments made, and state  
law only authorizes license revocation for cause. Regardless of whether the MRA’s assertions are  
legally accurate, it is patently unfair to deny the existence of a property right where substantial  
investments are made based on licensure and such licenses may only be revoked for good causes  
and pursuant to due process.  
Application Fees  
Proposed Rule 420.7 lowers initial licensure and renewal fees and abandons the process of  
calculating renewal fees based on gross weight transferred for growers, gross retail sales for  
retailers and microbusinesses, net weight transported for transporters, and number of tests  
completed for laboratories. The MICIA supports these common-sense changes.  
Moral Character  
Proposed Rule 420.13(1)(a) retains language for requiring license renewals under the  
MMFLA to include “information regarding the identification, integrity, moral character,  
reputation, relevant business experience, ability, probity, financial experience, and responsibility  
of the licensee and each person required to be qualified for renewal of the license under the  
MMFLA.” The MICIA opposes the inclusion of such subjective attributes of the licensee such as  
moral character and further notes Senate Bill 619, if enacted, would remove language allowing the  
MRA to deny a license to any applicant on account of their “moral character” or if they have any  
previous marijuana-related offenses. License denials based on hyper-subjective criteria create the  
appearance of arbitrary application.  
13  
ClarkHill\98902\346090\264189386.v2-9/26/21  
Marihuana Educational Research License  
Proposed Rule 420.21(1)(e) adds marihuana educational research licenses to the list of  
special licenses which may be issued by the agency. And, Proposed Rule 420.27a sets forth the  
rights and obligations of a person holding a marihuana educational research license. The MICIA  
supports these changes.  
Excess Grower License Fees  
Proposed Rule 420.23(11) provides that “[a]n applicant for an excess grower license is not  
required to pay the application fee under these rules.”  
The MICIA highlights that this provision benefits the largest growers and that many of the  
growers who are not capable of achieving this license type view this fee waiver as inequitable. The  
MICIA submits that the various grower license types should be treated uniformly.  
VIII. RULE SET 2020-123 LR (MARIHUANA SALE OR TRANSFER, R. 420.501 ET  
SEQ)  
This Proposed Rule Set seeks to amend portions of Rule 420.501 through Rule 420.510 to,  
inter alia, address the transfer and/or destruction of expired products; product warning labels and  
advisory pamphlet distribution; and employee limits for internal and trade samples. The Proposed  
Rule Set also adds a new Rule 420.503a authorizing the transfer of immature plant batches without  
utilization of a transporter. The MICIA’s comments are below.  
Definition of Final Form  
Proposed Rule 420.501(g) defines “final form” as “the form a marihuana product is in  
when it is available for sale by a marihuana sales location. For marihuana products intended for  
inhalation, final form means the marihuana concentrate in an e-cigarette or a vaping device.”  
The MICIA requests that the agency clarify that prerolls, deli-style bulk flower packaged  
by a retailer, and batches of edibles divided into multiple packages, are not required to undergo an  
additional level of testing. See also Proposed Rule 420.504(1)(i).  
Destruction of Expired Products  
Proposed Rule 420.502(4) provides that “[a] marihuana business shall not sell or a [SIC]  
transfer marihuana product after the printed expiration date on the package. An expired marihuana  
product must be destroyed.” Proposed Rule 420.502(6) provides that “[a] marihuana business shall  
destroy all product required to be destroyed for any reason within 90 calendar days of when the  
marihuana business became aware of the fact that the product must be destroyed.”  
The MICIA supports these proposed changes for public safety purposes and requests that  
the agency clarify that expired product may be transferred from a retailer to a processor for  
destruction. The MICIA also identifies that this requirement will increase costs and submits that  
the agency’s cost-benefit analysis is deficient.  
14  
ClarkHill\98902\346090\264189386.v2-9/26/21  
Transfer of Immature Plant Batches  
Proposed Rule 420.503a authorizes approved cultivators to sell or transfer immature plant  
batches to a marihuana sales location without using a marihuana transporter and without  
conducting testing. The MICIA supports these common-sense regulations.  
Labeling Warnings  
Proposed Rule 420.504(1)(v) creates the following labelling requirement: “In clearly  
legible type and surrounded by a continuous heavy line: “WARNING: USE BY PREGNANT OR  
BREASTFEEDING WOMEN, OR BY WOMEN PLANNING TO BECOME PREGNANT,  
MAY RESULT IN FETAL INJURY, PRETERM BIRTH, LOW BIRTH WEIGHT, OR  
DEVELOPMENTAL PROBLEMS FOR THE CHILD.”  
The MICIA supports this labelling requirement which is expressly required by MCL  
333.27206. The MICIA nevertheless asserts that this requirement will substantially increase  
labeling costs and submits that the agency’s cost-benefit analysis is incorrect in asserting  
otherwise.  
Advisory Pamphlet  
Proposed Rule 420.504(4) creates the following requirement: “Before a marihuana product  
is sold or transferred by a marihuana sales location, the sales location shall make available to each  
customer a pamphlet measuring at least 3.5 inches by 5 inches, that includes safety information  
related to marihuana use by minors and the poison control hotline number. The pamphlet must  
substantially conform to the design published on the agency’s website.”  
The MICIA supports this advisory requirement which is expressly required by MCL  
333.27206. The MICIA nevertheless asserts that this requirement will substantially increase  
labeling costs and submits that the agency’s cost-benefit analysis is incorrect in asserting  
otherwise.  
Employee Transfer Limits for Internal and Trade Samples  
Proposed Rule 420.508(8) provides that “[a] producer or marihuana sales location is  
limited to transferring a total of 1 ounce of marihuana, a total of 2 grams of marihuana concentrate,  
and marihuana infused products with a total THC content of 2000 mgs of internal product samples  
to each of its employees in a 30-day period.” Similarly, Proposed Rules 420.509(6) provides that  
“[a] marihuana sales location, marihuana microbusiness, and class A marihuana microbusiness are  
limited to transferring a total of 1 ounce of marihuana, a total of 2 grams of marihuana concentrate,  
and marihuana infused products with a total THC content of 2000 mgs of internal product samples  
to each of its employees in a 30-day period.”  
The MICIA supports these additional clarifications regarding internal and trade sample  
transfers.  
15  
ClarkHill\98902\346090\264189386.v2-9/26/21  
IX.  
RULE SET 2020-122 LR (OPERATIONS, R. 420.201 ET SEQ.)  
This Proposed Rule Set seeks to amend portions of Rule 420.201 through Rule 420.214 to,  
inter alia, require maintenance of certain financial records and provide for the regulation of natural  
and synthetic cannabinoid sourcing. The Proposed Rule Set also adds new Rules 420.206a  
(standard operating plan), 420.207a (contactless tracing), 420.214a (internal analytical testing),  
420.214b (adverse reactions), and 420.214c (product returns). The MICIA’s comments are below.  
Financial Records  
Proposed Rule 420.204(2) adds new language stating the following: “(i) A licensee shall  
maintain accurate and comprehensive financial records for each license that clearly documents the  
licensee’s income and expenses. Applicable supporting source documentation must be maintained,  
including, but not limited to, all of the following: (A) Cash logs. (B) Sales records. (C) Purchase  
of inventory. (D) Invoices. (E) Receipts. (F) Deposit slips. (G) Cancelled checks. (H) Employee  
compensation records. (I) Tax records. (ii) Bulk financial deposits or transactions must be traceable  
to the individual transactions that comprise the bulk deposit or transaction.”  
These new more granular financial recordkeeping requirements will increase costs and the  
MRA has failed to engage in any cost-benefit analysis related to the impact of these requirement  
on the industry. MCL 24.245(3).  
Cannabinoid Sourcing and Synthetically-Derived Cannabinoids  
Proposed Rule 420.206(13) adds new language providing that “[a]ll ingredients containing  
cannabinoids, whether naturally occurring or synthetically derived, that are added to marihuana or  
marihuana products must be from a source licensed to grow, handle, and produce cannabinoids  
under a license issued by a governmental authority and entered into the statewide monitoring  
system.”  
The MICIA submits that the use of the term “cannabinoids” in the Proposed Rule may be  
overbroad and may encompass any and all industrial hemp products. MCL 333.7106(2); MCL  
286.842(i). The MICIA requests that the MRA add language providing that “a source authorized  
to grow, handle, and produce cannabinoids pursuant to an Industrial Hemp Pilot Program created  
by state statute or regulation” is also acceptable. The MICIA further cautions against the blanket  
authorization of synthetic cannabinoids and synthetic processing where certain synthetic  
cannabinoids such as “K2” and “Spice” are extremely dangerous to public health and safety and  
synthetic production involves a substantial risk of product adulteration by toxic reagents and/or  
byproducts. The MICIA believes that this rule should be revised to explicitly ban all fully or semi-  
synthetic cannabinoids from the Michigan marijuana industry, except those produced incidentally  
by otherwise non-synthetic processing steps that have been approved by the agency.  
Testing for Product Combination  
Proposed Rule 420.206(14) adds new language providing that “[w]hen combining more  
than 1 form of marihuana or marihuana product into a single marihuana product, each form of  
16  
ClarkHill\98902\346090\264189386.v2-9/26/21  
marihuana or marihuana product must have passing safety compliance test results in the statewide  
monitoring system prior to the creation of the new combined product.”  
The MICIA flatly opposes this new and non-sensical requirement as both ultra vires and  
unreasonably impractical. There is no added health or safety benefit gained by testing the same  
product three different times; only three separate testing fees and three separate samples being  
destroyed from each batch. These new testing requirements will substantially increase costs and  
the MRA has failed to engage in any cost-benefit analysis related to the impact of these  
requirement on the industry. MCL 24.245(3).  
Standard Operating Plan  
Proposed Rule 420.206a adds new language providing that “[a] marihuana business must  
have up-to-date written standard operating procedures on site at all times . . . [which] must detail  
the marihuana business operations and activities necessary for the marihuana business to comply  
with the acts and these rules [and] . . . comply with any guidance issued by the agency.”  
While not opposed to standard operating plans, which are beneficial to licensees, the  
MICIA opposes government mandates (and associated regulatory enforcement) of such a broad  
requirement for licensees to have “up-to-date” and “written” procedures that “detail” compliance  
with every single present or future statutory, regulatory, or even informal guidance requirement of  
the MRA. That a mandatory SOP detail compliance with informal guidance is plainly at odds with  
the APA and this Proposed Rule, as written, is unreasonably impractical. Moreover, this new  
requirement will substantially and continually increase costs and the MRA has failed to engage in  
any cost-benefit analysis related to the impact of these requirement on the industry. MCL  
24.245(3); MCL 243.203(7) (defining a “guideline” as “an agency statement or declaration of  
policy that the agency intends to follow, that does not have the force or effect of law,  
and that binds the agency but does not bind any other person”).  
Contactless and Limited Contact Transactions  
Proposed Rule 420.207a adds new language authorizing and regulating the process for  
contactless and limited contact transactions (including online orders) “unless prohibited by an  
ordinance adopted by the municipality where the marihuana sales location is located.” Such  
transactions are authorized during normal business hours provided that “the designated area for  
contactless or limited contact transactions [is] identified in the marihuana business location plan,”  
the “marihuana sales location [has] a written standard operating procedure in place,” the  
“marihuana sales location using a designated area for contactless or limited contact transactions  
[has] in place an anti-theft policy, procedure, or automatic capability,” the “designated area for  
contactless or limited contact transactions [complies] with R 420.209,” the “contactless and limited  
contact transaction [complies] with R 420.505 and R 420.506,” and the “[m]arihuana being  
transferred during a contactless or limited contact transaction [is] in an opaque bag and the contents  
[are] not be visible to the general public upon pick up.”  
The MICIA supports this very necessary Proposed Rule with the exception that any  
municipal prohibition on contactless transactions should be both direct and specific. As such, the  
17  
ClarkHill\98902\346090\264189386.v2-9/26/21  
phrase should read “unless DIRECTLY AND SPECIFICALLY prohibited by an ordinance  
adopted by the municipality where the marihuana sales location is located.”  
Storage of Marihuana Product  
Proposed Rule 420.212(3) requires all chemicals or solved to be “stored separately from  
marihuana products and kept with a closed lid in locked storage areas.”  
The MICIA suggests that the phrase “with a closed lid” be replaced with the phrase “in a  
closed container” for reason that not all chemicals and solvents are packaged in a container with a  
lid.  
Internal Analytical Testing  
Proposed Rule 420.214a adds new language authorizing and regulating the process for  
internal analytical testing. The MICIA generally supports this Proposed Rule with the following  
exceptions:  
The MICIA asks for clarification and examples of the meaning of the phrase “fully  
partitioned” as used in Proposed Rule 420.214a(1)(a) (i.e., whether a partition includes walls,  
dividers, curtains, etc).  
The MICIA requests that the MRA strike the requirement in Proposed Rule 420.214a(1)(c)  
that the product of only one license may be in co-located internal analytical testing spaces at a  
time. The MICIA fails to see the necessity of this requirement where such products are required to  
be disposed of, the products cannot return to the licensee, and the results from the testing cannot  
be used to release the products to the public.  
The MICIA seeks clarification regarding the prohibition in Proposed Rule 420.214a(4) that  
“[n]o marihuana or marihuana product may be stored in the internal analytical testing space.” The  
MICIA submits that the samples of products being internally tested should be permitted to be  
stored in the space.  
The MICIA opposes the requirement in Proposed Rule 420.214a(8) that “[a]ny batch of  
marihuana or a marihuana product that has undergone internal analytical testing must undergo full  
safety compliance testing, with failing test results entered into the statewide monitoring system,  
prior to making a request for remediation.” This requirement seems to impose a requirement of  
outside finished testing prior to remediation and thus limits the ability of licensees to proactively  
remediate products. Such a requirement would mark a significant departure from current practice.  
Adverse Reactions  
Proposed Rule 420.214b adds new language requiring that “[a] licensee shall notify the  
agency within 1 business day of becoming aware or within 1 business day of when the licensee  
should have been aware of any adverse reactions to a marihuana product sold or transferred by any  
18  
ClarkHill\98902\346090\264189386.v2-9/26/21  
licensee” and that “[a] licensee shall enter into the statewide monitoring system within 1 business  
day of becoming aware of or within 1 business day of when the licensee should have been aware  
of any adverse reactions to a marihuana product sold or transferred by any licensee.”  
The MICIA asks that the MRA define what constitutes an “adverse reaction” and clarify  
whether the phrases “becoming aware” or “should have been aware” encompass only actual  
adverse reactions or also customer alleged or perceived adverse reactions. The MICIA further  
requests that the agency issue a form or more detailed guidance as to how to submit such  
information and identifies that, at present, there is not a method for licensees to upload this  
information into METRC.  
Product Returns  
Proposed Rule 420.214c(1) adds new language applicable to marihuana sales locations that  
authorizes “the return of marihuana product that is reported to have caused an adverse reaction or  
is determined to be defective.” Proposed Rule 420.214c(2) further requires that “[a] marihuana  
sales location must have a written policy for the return of marihuana product that contains, at a  
minimum, the following: (a) Product returned to a marihuana sales location must be tracked  
consistently in the statewide monitoring system as waste in compliance with R 420.211. (b)  
Product returned to a marihuana sales location must be destroyed in compliance with R 420.211  
within 90 calendar days of when the marihuana business became aware of the fact that the product  
must be destroyed. (c) Product returned to a marihuana sales location cannot be re-sold, re-  
packaged, or otherwise transferred to a customer or another marihuana business. (d) Product  
returned to a marihuana sales location shall be returned by the customer who purchased the  
product. (e) Product returned to a marihuana sales location is prohibited from being returned to the  
marihuana sales location by way of a delivery driver. (f) A marihuana sales location that does not  
comply with these rules may be subject to disciplinary proceedings. (g) A marihuana retailer may  
return a marihuana product that is past its expiration date to the marihuana processor who produced  
the marihuana product for destruction instead of destroying the marihuana product.”  
The MICIA requests that the agency issue a form or more detailed guidance as to how to  
submit such information and identifies that, at present, there is not a method for licensees to upload  
this information into METRC. The MICIA further submits that the phrase “reported to have caused  
an adverse reaction or is determined to be defective,” is vague and potentially overbroad. The  
agency has neither defined the terms “adverse reaction” nor “defective” and the phrase “reported  
to have caused,” read literally, could mean “alleged by anyone no matter how far removed.”  
Furthermore, the MICIA asks that the agency reconsider the prohibition in Proposed Rule  
420.214c(2)(d) that “[p]roduct returned to a marihuana sales location shall be returned by the  
customer who purchased the product.” This requirement may be extraordinarily difficult to enforce  
and, as set out in the proposed rule, appears to potentially suggest that a marihuana sales location  
may be subject to disciplinary proceedings as a result of third-party conduct completely outside  
the location’s control.  
X.  
RULE SET 2020-124 LR (SAMPLING AND TESTING R. 420.301 ET SEQ.)  
This Proposed Rule Set seeks to amend portions of Rule 420.301 through Rule 420.307 to,  
inter alia, set maximum batch sizes, revise laboratory accreditation requirements and testing  
19  
ClarkHill\98902\346090\264189386.v2-9/26/21  
methodologies, require safety tests on harvest batches, redefine potency analyses, and mandate  
laboratory policies for potentially hazardous contaminants. The Proposed Rule Set also adds a new  
Rule 420.303a, establishing producer and sales location packaging and testing requirements, and  
Rule 420.305a, establishing certain validation requirements. The MICIA’s comments are below.  
Batch Identification and Testing  
Proposed Rule 420.303(4) provides that “[a] cultivator shall immediately destroy the  
individual plant tag once a tagged plant is harvested and is part of a harvest batch so that a sample  
of the harvest batch can be tested by a licensed laboratory as provided in R 420.304 and R  
420.305.”  
The MICIA requests that the agency clarify that the individual plant tags (which are used  
to identify the plants during the drying stage) do not need to be destroyed until after the drying  
stage is complete.  
Proposed Rule 420.303(6) provides that “[a] cultivator may transfer or sell fresh frozen  
marihuana to a producer without first being tested by a laboratory in order to produce live resin,  
or if the marihuana product will be extracted, with agency approval.”  
The MICIA requests that the agency revise the Proposed Rule so that “fresh frozen”  
includes “any dried biomass” and to replace the term “live resin” with the term “concentrate.”  
Producer and Sales Location Packaging and Testing Requirements  
Proposed Rule 420.303a(1) and (2) clarifies that “[a] producer shall give a marihuana  
product a new package tag anytime the marihuana product changes form or is incorporated into a  
different product,” “[a] producer of a marihuana product in its final form shall have the sample  
tested pursuant to R 420.304 and R 420.305,” “[t]he producer shall quarantine products from all  
other products when the product has test results pending,” “[t]he producer shall not transfer or sell  
a marihuana product to a marihuana sales location until after test results entered into the statewide  
monitoring system indicate a passed result for all required safety tests,” and that “[n]othing in this  
subsection prohibits a producer from transferring or selling a package in accordance with the  
remediation protocol provided by the agency and these rules.” Proposed Rule 420.303a(3) further  
clarifies that “[a] marihuana sales location may sell or transfer a marihuana product only to a  
marihuana customer under both of the following conditions: (a) The marihuana product has  
received passing results for all required safety tests in the statewide monitoring system. (b) The  
marihuana product bears the label required under the acts and these rules for retail sale.”  
The MICIA supports these proposed clarifications.  
Sample Collection  
Proposed Rule 420.304(2)(a) provides that “[t]he laboratory shall physically collect the  
sample the marijuana product from another business to be tested at the laboratory.”  
20  
ClarkHill\98902\346090\264189386.v2-9/26/21  
MICIA’s only comment is that it appears a typographic error exists; the sentence should  
read: “The laboratory shall physically collect the marijuana product sample from another business  
to be tested at the laboratory.”  
Maximum Batch Size  
Proposed Rule 420.304(2)(d) further provides that “[t]he laboratory shall develop a  
statistically valid sampling method and have it approved by the agency to collect a representative  
sample from each batch of marihuana product. The laboratory shall have access to the entire batch  
for the purposes of sampling.”  
The MICIA submits that “statistically valid sampling method” is too vague and that  
additional guidance should be provided in the proposed rule.  
Laboratory Accreditation Requirements  
Proposed Rule 420.305(1) provides that “A laboratory shall become fully accredited for all  
required safety tests in at least 1 required matrix to the International Organization for  
Standardization (ISO), ISO/IEC 17025:2017, by an International Laboratory Accreditation  
Corporation (ILAC) recognized accreditation body or by an entity approved by the agency within  
1 year after the date the laboratory license is issued and agree to have the inspections, reports, and  
all scope documents sent directly to the agency from the accreditation body.”  
The MICIA submits that these provisions should be amended to read only that:  
A laboratory shall become fully accredited for all required safety tests in all  
required matrices to the International Organization for Standardization (ISO),  
ISO/IEC 17025:2017, by an International Laboratory Accreditation Corporation  
(ILAC) recognized accreditation body or by an entity approved by the agency prior  
to and as a condition of license issuance and agree to have the inspections, reports,  
and all scope documents sent directly to the agency from the accreditation body.  
Accreditation protects public health and safety and there is no longer any need for post-licensure  
accreditation nor the issuance of variances for accreditation. When the MRA was established in  
2018, only four labs were operating in the state, and thus good cause existed for these exceptions  
to accreditation. Now, almost three years later, with fifteen licensed and operating testing  
laboratories, there is no need for the lower bar. Accreditation ensures that a laboratory has a  
functional quality system, complete with validated test methods, to ensure the accuracy of  
published test results.  
Laboratory Testing Methodologies  
Proposed Rule 420.305(2) provides, in part, that “[a] laboratory shall use analytical testing  
methodologies for the required safety tests in subrule (3) of this rule that are validated by an  
independent third party and may be monitored on an ongoing basis by the agency. In the absence  
of published, peer reviewed, validated cannabis methods, Appendix J or K of Official Methods of  
21  
ClarkHill\98902\346090\264189386.v2-9/26/21  
Analysis authored by the Association of Official Analytical Collaboration (AOAC) International  
must be published in full with guidance from published cannabis standard method performance  
requirements where available.”  
The MICIA submits that the proposed language does not clearly reflect the intent of the  
Rule nor the way in which the Rule has been enforced to date. In its place, the MICIA asks the  
MRA to consider the following language:  
A laboratory shall use analytical testing methodologies for the required safety tests  
in subrule (3) of this rule that are based upon published peer-reviewed methods,  
have been validated for cannabis testing by an independent third party, may be  
monitored on an ongoing basis by the agency, and have been internally verified by  
the licensed laboratory according to Appendix K of Official Methods of Analysis  
authored by the Association of Official Analytical Collaboration (AOAC)  
International, with guidance from published cannabis standard method  
performance requirements where available. In the absence of published, peer-  
reviewed, validated cannabis methods, method validation requirements of  
Appendix K of Official Methods of Analysis must be met in full with guidance  
from published cannabis standard method performance requirements where  
available.  
Safety Tests on Harvest Batches  
Proposed Rule 420.305(3) provides, in part, that “[a] laboratory shall conduct the required  
safety tests specified in subdivisions (a) through (i) of this subrule on marijuana product that is  
part of a harvest batch as specified in R420.303, except as provided in subrule (4) of this rule. The  
agency may publish minimum testing portions to be used in compliance testing.”  
The MICIA reads this language as limiting safety testing to marijuana product that is part  
of a harvest batch (which is only plant material by definition) and thus as excluding testing  
requirements for marijuana products that are not part of a harvest batch such as concentrates and  
infused products. The agency should clarify its intention in that regard. The MICIA supports the  
agency publishing minimum testing portions to be used in compliance testing.  
Potency Analysis  
Proposed Rule 420.305(3)(a)(i) states that “[i]n the preparation of samples intended for  
potency analysis, the laboratory may not adulterate or attempt to manipulate the total potency of  
the sample by adding trichomes that were removed during the grinding and homogenization  
process.”  
The MICIA opposes this prohibition for reason that it leads to results that are not  
representative. Simply because a testing lab “damages” or knocks portions off of a licensee’s  
product, does not mean that those portions should not be included in the potency test.  
22  
ClarkHill\98902\346090\264189386.v2-9/26/21  
Proposed Rule 420.305(3)(a)(ii) states, in part, that “Kief must not be reintroduced to the  
flower sample during the homogenization process.”  
The MICIA opposes this prohibition for reason that it leads to results that are not  
representative. Kief created during the grinding process is customarily kept and reintroduced by  
the average consumer.  
Proposed Rule 420.305(3)(a)(iii) defines the list of legally required cannabinoids for  
potency testing as: “(A) Total Tetrahydrocannabinol (THC); (B) Tetrahydrocannabinol Acid  
(THC-A); (C) Total Cannabidiol (CBD); (D) Cannabidiol Acid (CBDA); [and] (E) Additional  
cannabinoids may be tested with approval from the agency.”  
The MICIA reads the rule as only requiring potency test results for the four cannabinoids  
in items (A) through (D) of the subrule. Consequently, the subrule does not authorize potency  
testing of d9-THC or Cannabidiol. By default, these two important compounds fall into optional  
analyte category (E). Omitting mandatory reporting of d9-THC and Cannabidiol test results is not  
recommended. The MICIA also submits that the correct term for “Tetrahydrocannabinol Acid” is  
“Tetrahydrocannabinoic Acid” and the correct term for “Cannabidiol Acid” is “Cannabidiolic  
Acid.”  
Proposed Rule 420.305(9) further defines the list of legally required cannabinoids for  
potency testing and provides that “[p]otency shall include the following cannabinoid  
concentrations listed in subdivisions (a) to (f) of this subrule, subject to subdivisions (g) and (h) of  
this subrule:  
(a) Total THC concentration;  
(b) THC-A concentration;  
(c) Total THC, which includes Delta 7, Delta 8, Delta 9, Delta 10, and Delta 11  
THC and THC-A. The following calculation must be used for calculating Total  
THC, where M is the mass or mass fraction of delta-9 THC or delta-9 THC-A: Σ  
Delta 7-11 THC + Σ ((Delta 7-11 THCA) x 0.877)=Total THC;  
(d) Total CBD concentration;  
(e) CBD-A concentration;  
(f) Total CBD. The following calculation must be used for calculating Total CBD,  
where M is the mass or mass fraction of CBD and CBD-A: M total CBD = M CBD  
+ 0.877 x M CBD-A;  
(g) For marihuana and marihuana concentrates, total THC and total CBD must be  
reported in percentages; [and]  
(h) For marihuana infused products, potency must be reported as milligrams of  
Delta-9-THC and CBD.”  
The MICIA reads the proposed rule as only requiring reporting of test results for items (a)  
through (f) of the subrule. As such, this list no longer mandates individually reporting of d9-THC  
or Cannabidiol test results. By default, these important compounds fall into optional analyte  
category (E). Omitting mandatory reporting of d9-THC and Cannabidiol test results is not  
recommended. The MICIA also submits that Rules 420.305(9)(a) and (c) are redundant. The  
23  
ClarkHill\98902\346090\264189386.v2-9/26/21  
agency should change “Total THC concentration” in Rule 420.305(9)(a) to “delta-9 THC  
Concentration.”  
Furthermore, the definition in Rule 420.305(9)(c) of compounds that comprise “Total  
THC” is problematic such that reporting of Total THC results, as defined, cannot be met at this  
time where (i) certified analytical reference standards for Delta7-THC (a fully synthetic and non-  
psychoactive cannabinoid) may not be fully and commercially available at this time; (ii) certified  
reference standards for Delta 10-THC (a fully synthetic cannabinoid) are available for two separate  
enantiomers: Delta 10 (6aR, 9S), which is not psychoactive, and Delta 10 (6aR, 9R), which is  
psychoactive;3 (iii) although there are various forms of nomenclature, the term “Delta 11 THC” is  
not a consistently recognized term in current scientific literature;4 and (iv) the calculation provided  
for determining Total THC includes summing the concentrations of “Delta 7-11 THCA.”5  
Consequently, MICIA recommends that the potency testing requirements be revised to allow the  
MRA to publish a list of cannabinoids for mandatory testing and reporting and to update the list  
as needed via bulletins separately from the Rules. It is important to address the emergence of  
additional THC isomers (like delta-8 THC) without prematurely and unnecessarily complicating  
the Proposed Rule.  
Residual Solvent Testing as Part of Harvest Batch  
Proposed Rule 420.305(3)(f) includes “Residual Solvents” as a required safety test for a  
marijuana product that is part of a harvest batch. Because residual solvent testing has not been  
required for plant material to date, the MICIA suggests that this subrule be deleted, especially  
where subrule 420.305(7) properly addresses residual solvent testing.  
Reporting Units for CBD  
Proposed Rule 420.305(9)(h) states that “[f]or marijuana infused products, potency must  
be reported in milligrams of Delta-9 THC and CBD.”  
The MICIA suggests that this language does not adequately define reporting units for CBD.  
While the definition provides a magnitude (milligrams), it does not specify the quantity. That is,  
the language does not specify whether the quantity be a milliliter of analytical solution, gram of  
product, serving, etc. By requiring reporting of individual test results for Delta 9-THC and CBD  
for infused products, the subrule also seems to conflict with Proposed Rules 420.305(3)(a)(iii) and  
420.305(9) which provide that these analytes are defined as optional.  
3
The Proposed Rule should clarify whether both enantiomers or, if only one, which enantiomer  
must be quantified.  
4
Provided that the term “Delta 11 THC” intends to describe THC with a double bond between  
carbon atoms 9 and 11, the MICIA would prefer the nomenclature “exo-THC,” as certified  
reference standards are available for “exo-THC.”  
5
This requires a laboratory to individually quantify delta 7, delta 8, delta 10, and delta 11 THC  
acids. Certified reference standards for these cannabinoic acids do not currently exist in the  
literature, and the delta-9 THC acid isomers themselves may not be known compounds at all at  
this time.  
24  
ClarkHill\98902\346090\264189386.v2-9/26/21  
Terpene Analysis  
Proposed Rule 420.305(18) states that “[a] laboratory may perform terpene analysis on a  
marijuana product by a method approved by the agency, and the method must be accredited on the  
same frequency as all required safety tests. There are no established safety standards for this  
analysis.”  
The MICIA recommends that the phrase “[t]here are no established safety standards for  
this analysis” be omitted, because safety tests for beverages include a requirement to test for  
phytol.  
Laboratory Policy for Potentially Hazardous Contaminants  
Proposed Rule 420.305(21) states that “[a] laboratory shall have a policy or procedure in  
place for handling and reporting any potentially hazardous contaminants that may be encountered  
during routine testing. A laboratory shall notify the agency if a test batch is found to contain levels  
of a contaminant that could be injurious to human health.”  
The MICIA suggests that this requirement is vague and overbroad and should not be  
included in the Proposed Rules without further clarification. Licensed laboratories are not  
equipped or otherwise required to identify unknown compounds of any type in product samples.  
In addition, under the right conditions and without further clarification, just about any compound  
fits the terms “potentially hazardous” and “potentially injurious to human health.”  
STEC Reporting Deadline  
Proposed Rule 420.305(22) states that “[m]arihuana-infused products found to contain  
Salmonella spp. or Shiga toxin producing E. coli (STEC) must be reported to the agency  
immediately.”  
The MICIA submits that it is unclear how immediate reporting for STEC required under  
this Proposed Rule fits with Rules 420.305(12) and (13) which requires reporting within three  
business days. The MRA should consider omitting or clarifying this Proposed Rule. If the MRA  
chooses to clarify this Proposed Rule, the MICIA suggests that the term “immediately” should be  
replaced with the phrase “within one business day.”  
Validation Protocols  
Proposed Rule 420.305a sets forth a litany of new validation protocols and requirements.  
The MICIA submits that these new requirements will increase laboratory costs and that the MRA  
has failed to engage in any cost-benefit analysis related to the impact of these requirement on the  
industry. MCL 24.245(3).  
Proposed Rule 420.305a(2)(b) provides that “[v]alidation protocols should perform  
inoculation of marihuana matrices with live organisms where feasible to ensure that both extraction  
and detection for the assay are tested. To further test the accuracy of the assay, probability of  
25  
ClarkHill\98902\346090\264189386.v2-9/26/21  
detection (POD) analyses, inclusivity, exclusivity, lot-to-lot stability, and robustness studies must  
be included in the validation studies.”  
The MICIA submits that “lot-to-lot stability” testing is not appropriate as a test method  
validation requirement and should be removed from this sub-rule. “Lot-to-lot stability” is a process  
validation, typically included in validation of a manufacturing process, and is not appropriately  
employed as an element of analytical method validation.  
Quality Assurance and Control  
Proposed Rule 420.305b creates a quality assurance and quality control monitoring regime  
and requires that laboratories adopt and follow detailed written quality assurance measures and  
standard operating procedures approved by the agency.  
The MICIA is concerned that the quality control acceptance criteria currently published by  
the agency exceed the capabilities of established, industry-accepted test methods, and are more  
stringent than criteria assigned to those methods by the method authors / innovators. MICIA  
submits that while published MRA guidance is essential and appropriate, where available, method  
author / innovator quality control acceptance criteria should prevail. The MICIA further submits  
that these new requirements are likely to substantially increase laboratory costs and that the MRA  
has failed to engage in any cost-benefit analysis related to the impact of these requirement on the  
industry. MCL 24.245(3). Abandoning existing, approved and accredited methods simply to meet  
tightened MRA specifications without regard to actual existing method capabilities may include  
major financial impact, including purchasing expensive new equipment and discarding perfectly  
adequate existing equipment.  
The MICIA additionally identifies that the phrase “method acceptance criteria is required”  
in Rule 420.305b(6) should be revised to “method acceptance criteria are required.”  
Aspergillus Remediation  
Proposed Rule 420.306(3) provides that “[p]roducts that failed testing for Aspergillus are  
ineligible for remediation.”  
The MICIA suggests that products which fail testing for Aspergillus should be further  
tested and, if applicable, remediated for Mycotoxins. Testing for mycotoxins identifies the  
presence of aspergillus which, itself, is ubiquitous. This proposed process is similar to the process  
followed by the USDA https://www.ams.usda.gov/publications/content/fgis%E2%80%99s-role-  
aflatoxin-testing  
Retest Costs  
Proposed Rule 420.306(5) provides that “[t]he marihuana business that provided the  
sample is responsible for all costs involved in a retest.”  
26  
ClarkHill\98902\346090\264189386.v2-9/26/21  
The MICIA highlights that the various license types have different perspectives on this  
provision. The MICIA submits that the MRA should not inflexibly dictate commercial terms but  
should instead leave it to the individual businesses to contract amongst themselves for apportioning  
such costs.  
CONCLUSION  
MICIA appreciates the opportunity to comment on the MRA’s proposed rules and the  
MRA’s efforts to develop a sound regulatory structure for the cannabis industry. MICIA believes  
that with the changes suggested above, greater industry feedback, and more thorough vetting of  
the costs and benefits of proposed regulations, Michigan can be a leader both economically and in  
its promotion of good business practices for the industry.  
Respectfully submitted,  
Robin Schneider, Executive Director  
Michigan Cannabis Industry Association  
www.MICannabisIndustryAssociation.org  
27  
ClarkHill\98902\346090\264189386.v2-9/26/21  
AUGUST 2021, PROPOSED MRA ADMINISTRATIVE RULE  
COMMENTS FROM THE SPOTT LABORATORY  
MARIJUANA DECLARATORY RULINGS  
No Comments  
MARIJUANA DISCIPLINARY PROCEEDINGS  
No Comments  
MARIJUANA EMPLOYEES  
No Comments.  
MARIJUANA HEARINGS  
No Comments.  
MARIJUANA SALE OR TRANSFER  
No Comments  
MARIJUANA LICENSES  
1. R420.13(1)(a) states:  
“For a licensee seeking renewal under the MMFLA, required information may also be related to the  
suitability and general fitness of the licensee and include without limitation, information regarding the  
identification, integrity, moral character, reputation, relevant business experience, ability, probity,  
financial experience, and responsibility of the licensee and each person required to be qualified for  
renewal of the license under the MMFLA.”  
The required license renewal information listed in this section of the Rule is blatantly discriminatory,  
based upon subjective attributes of the licensee that are not required for initial licensure and are not  
enforceable. This section of the Rule should be omitted in its entirety.  
Page 1 of 8  
MARIJUANA-INFUSED PRODUCTS AND EDIBLE MARIJUANA PRODUCT  
1. R420.402(2) states:  
Copies of these standards may be obtained by the agency at the cost indicated in subrule (1)(a) to (c)  
of this rule, plus shipping and handling.”  
Copying and resale of copyrighted material is very likely a constitutional and legal violation.  
Government agencies are not immune to the Fair Use Doctrine found in Article I, section 8 of the  
Constitution or to the Copyright Act of 1976.  
2. R420.403(8)(a) states:  
“(8) A producer of edible marihuana product shall comply with all the following:  
(a) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative  
Controls for Human Food, 21CFR part 117.- Any potentially hazardous ingredients used to  
process shelf-stable edible marijuana products must be stored at 40 degrees Fahrenheit, 4.4  
degrees Celsius, or below.”  
It is recommended that “- Any potentially hazardous ingredients used to process shelf-stable  
edible marijuana products must be stored at 40 degrees Fahrenheit, 4.4 degrees Celsius, or below”  
is removed from the Rule.  
This type of detail is better placed in a clarifying bulletin/ guideline issued subsequent to the Rules  
where more clarity can be established.  
21CFR Part 117, § 117.80 - Processes and controls, provides the following adequate statement  
regarding storage of ingredients:  
(5) Raw materials, other ingredients, and rework must be held in bulk, or in containers designed and  
constructed so as to protect against allergen cross-contact and against contamination and must be held  
at such temperature and relative humidity and in such a manner as to prevent the food from becoming  
adulterated. Material scheduled for rework must be identified as such.  
The quoted language in R420.403(8)(a) attempts to require what is defined in 21CFR Part 117, §  
117.135 as a “Preventive Control,” without offering a licensee the opportunity to conduct a proper  
Hazard Analysis according to 21CFR Part 117, § 117.130 - Hazard Analysis to see if a Preventive  
Control is warranted. Further, the quoted language in R420.403(8)(a) applies this Preventive Control  
to an undefined sub-category of ingredients (“potentially hazardous ingredients used to process shelf-  
stable edible marijuana products”) without identifying the critical product attribute that is affected by  
storage temperature.  
3. R420.403(8)(b) states:  
“These records at a minimum must include the recipe, any additional processing documentation that  
demonstrates the product to be shelf stable and test results for all ingredients used.”  
It is recommended that “and test results for all ingredients used” is removed from the Rule.  
The quoted language implies that “all ingredients used” must be tested, without defining test  
requirements for non-active/ excipient ingredients.  
4. R420.403(11) provides a definition for “edible marijuana product.” This may be better placed in  
section 420.401, Definitions.  
Page 2 of 8  
MARIJUANA LICENSEES  
1. R420.107(1)(c) allows a testing lab to:  
“Receive marijuana fromand test marijuana for an individual 21 years of age or older, if the marijuana  
was produced by the individual and not purchased or obtained from a licensed marijuana business.”  
It is recommended that this be changed to read: “Receive marijuana from and test marijuana for  
an individual 21 years of age or older.”  
An adult in legal possession of marijuana should not be limited with respect to testing services based  
upon the legal source of the marijuana. Any adult should have access to product safety testing if they  
are concerned about the product for any reason, without limitation.  
•
Notably, when a sample is presented to a lab for testing that was obtained from a licensed  
business, the chain of custody will be broken on the sample and results cannot be used to  
represent batch quality. This makes the proposed limiting language unnecessary.  
•
If a sample is presented to a lab for testing by an adult, the lab has no way of definitively  
verifying/ proving its source, and neither does the MRA. This renders the rule unenforceable.  
2. R420.107(2)(c) and R420.112(2)state:  
“A marijuana safety compliance facility must be accredited by an entity approved by the agency within  
1 year after the date the marijuana safety compliance facility license is issued….”  
This should be changed to read: “A marijuana safety compliance facility must be accredited by an entity  
approved by the agency prior to issuance of a state operating license.”  
When the MRA was established in 2018, and only four labs were operating in the state, licensure  
issuance concurrently with accreditation efforts by a new lab made sense. This was a necessary  
approach to accelerate industry development. Now, almost three years later, with 15+ fully operating  
state cannabis labs, it is time to tighten accreditation requirements.  
Accreditation ensures that a lab has a functional Quality System, complete with validated test methods,  
to ensure the accuracy of published test results. This protects public health and safety.  
If a lab enters the industry without prior accreditation, the accuracy of test results that they generate  
cannot be guaranteed. The lab may operate for up to a full year with a sub-standard quality system and  
release potentially inaccurate results. In effect, this Rule codifies a double standard in which some labs  
are fully compliant, while newer labs are not. Public perception of the industry suffers and the Rule, as  
proposed, perpetuates the ongoing national problem of inconsistent cannabis lab results and associated  
‘lab shopping’ within the state of Michigan.  
The very least that the state of Michigan must do is to level the playing field with respect to laboratory  
accreditation and make it a pre-condition of licensing at this point in the development of the industry.  
Page 3 of 8  
MARIJUANA OPERATIONS  
1. R420.206(2) states:  
Copies of these standards may be obtained by the agency at the cost indicated in subrule (1)(a) and (b)  
of this rule, plus shipping and handling.”  
Copying and resale of copyrighted material is very likely a constitutional and legal violation.  
Government agencies are not immune to the Fair Use Doctrine found in Article I, section 8 of the  
Constitution or to the Copyright Act of 1976.  
2. R420.202(13) states:  
“All ingredients containing cannabinoids, whether naturally occurring or synthetically derived, that  
are added to marijuana or marijuana products must be from a source licensed to grow, handle, and  
produce cannabinoids under a license issued by a governmental authority and entered into the  
statewide monitoring system.”  
This language implies that synthetic cannabinoids are acceptable in Michigan, and that a license is  
available that allows for synthetic processing.  
Allowance for synthetic cannabinoids in the state of Michigan is not advised. Synthetic  
cannabinoids exist that are extremely dangerous to public health and safety, as evidenced by the  
“K2” or “Spice” synthetics that have previously emerged. These are not addressed by the rule as  
currently written. Even if a cannabinoid is a synthetically derived, but naturally occurring  
compound, synthetic production involves a substantial risk of product adulteration by toxic  
reagents and/ or byproducts. These Rules do not adequately regulate synthetic processing to protect  
public health and safety as currently written. The State of Michigan does not currently provide  
licensure for cannabinoid synthesis.  
This rule should be revised to explicitly ban all fully or semi-synthetic cannabinoids from the  
Michigan marijuana industry, except those produced incidentally by otherwise non-synthetic  
processing steps that have been approved by the agency.  
Page 4 of 8  
MARIJUANA SAMPLING AND TESTING  
3. R420.302(2) states:  
Copies of these standards may be obtained by the agency at the cost indicated in subrule (1)(a) to (c)  
of this rule, plus shipping and handling.”  
Copying and resale of copyrighted material is very likely a constitutional and legal violation.  
Government agencies are not immune to the Fair Use Doctrine found in Article I, section 8 of the  
Constitution or to the Copyright Act of 1976.  
4. R420.304(2)(a) states:  
“The laboratory shall physically collect the sample the marijuana product from another business...”  
A typographic error exists; the verbiage should read: “The laboratory shall physically collect the  
sample the marijuana product sample from another business....”  
5. R420.305(1) states:  
“A laboratory shall become fully accredited for all required safety tests in at least 1 required matrix to  
the International Organization for Standardization (ISO), ISO/IEC 17025:2017, by an International  
Laboratory Accreditation Corporation (ILAC) recognized accreditation body or by an entity approved  
by the agency within 1 year after the date the laboratory license is issued and agree to have the  
inspections, reports, and all scope documents sent directly to the agency from the accreditation body.”  
This should be changed to read: “A laboratory shall become fully accredited for all required safety  
tests in all required matrices to the International Organization for Standardization (ISO), ISO/IEC  
17025:2017, by an International Laboratory Accreditation Corporation (ILAC) recognized  
accreditation body or by an entity approved by the agency prior to and as a condition of license  
issuance and agree to have the inspections, reports, and all scope documents sent directly to the agency  
from the accreditation body.”  
When the MRA was established in 2018, and only four labs were operating in the state, licensure  
issuance concurrently with accreditation efforts by a new lab made sense. This was a necessary  
approach to accelerate industry development. Now, almost three years later, with 15+ fully operating  
state cannabis labs, it is time to tighten accreditation requirements.  
Accreditation ensures that a lab has a functional Quality System, complete with validated test methods,  
to ensure the accuracy of published test results. This protects public health and safety. If a lab enters  
the industry without prior accreditation, the accuracy of test results that they generate cannot be  
guaranteed. The lab may operate for up to a full year with a sub-standard quality system and release  
potentially inaccurate results. In effect, this Rule codifies a double standard in which some labs are  
fully compliant, while newer labs are not. Public perception of the industry suffers and the Rule, as  
proposed, perpetuates the ongoing national problem of inconsistent cannabis lab results and associated  
‘lab shopping’ within the state of Michigan.  
Also note that the statement “A laboratory shall become fully accredited for all required safety tests in  
at least 1 required matrix…” establishes that accreditation involves only one required matrix. This will  
limit the ability of MRA to require accreditation for additional matrices.  
The very least that the state of Michigan must do is to level the playing field with respect to laboratory  
accreditation and make it a pre-condition of licensing at this point in the development of the industry.  
Page 5 of 8  
6. R420.305(2) states:  
“A laboratory shall use analytical testing methodologies for the required safety tests in subrule (3) of  
this rule that are validated by an independent third party and may be monitored on an ongoing basis  
by the agency. In the absence of published, per-reviewed, validated cannabis methods, Appendix J or  
K of Official Methods of Analysis authored by the Association of Official Analytical Collaboration  
(AOAC) International must be published in full with guidance from published cannabis standard  
method performance requirements where available.”  
This language does not clearly reflect the intent of the Rule nor the way in which the Rule has been  
enforced to date. Alternate clarified verbiage is:  
“A laboratory shall use analytical testing methodologies for the required safety tests in subrule (3)  
of this rule that are based upon published peer-reviewed methods, have been validated for cannabis  
testing by an independent third party, may be monitored on an ongoing basis by the agency, and  
have been internally verified by the licensed laboratory according to Appendix K of Official Methods  
of Analysis authored by the Association of Official Analytical Collaboration (AOAC) International,  
with guidance from published cannabis standard method performance requirements where  
available. In the absence of published, per-reviewed, validated cannabis methods, method validation  
requirements of Appendix K of Official Methods of Analysis must be met in full with guidance from  
published cannabis standard method performance requirements where available.”  
(Note: Appendix K is specific to analytical testing and Appendix J is specific to microbial testing.  
7. R420.305(3) states:  
“A laboratory shall conduct the required safety tests specified in subdivisions (a) through (i) of this  
subrule on marijuana product that is part of a harvest batch as specified in R420.303, except as  
provided in subrule (4) of this rule.”  
Note that this statement limits safety testing to marijuana product that is part of a harvest batch which  
is only plant material by definition. This excludes testing requirements for marijuana products that  
are not part of a harvest batch such as concentrates and infused products.  
8. R420.305(3)(f) includes Residual Solvents as a required safety test for marijuana product that is part  
of a harvest batch. Residual solvent testing has not been required for plant material to date. This  
sub-rule should be deleted, as subrule R420.305(7) properly addresses residual solvent testing.  
9. R420.305(3)(a)(iii) defines the list of legally required cannabinoids for potency testing as:  
“(A) Total Tetrahydrocannabinol (THC)  
(B) Tetrahydrocannabinol Acid (THC-A)  
(C) Total Cannabidiol(CBD)  
(D) Cannabidiol Acid” (CBDA)  
(E) Additional cannabinoids may be tested with approval from the agency.”  
The following points are relevant and must be resolved prior to adoption of the Rule:  
a. Reporting of test results is legally required ONLY for the four entities in items (A) through (D) of  
the subrule as written. This list no longer mandates individually reporting of d9-THC or  
Cannabidiol test results – by default these important compounds fall into optional analyte  
category (E). Omitting mandatory reporting of d9-THC and Cannabidiol test results is not  
recommended.  
b. The correct terms for acid forms of cannabinoids are “Tetrahydrocannbinoic” and “Cannbidiolic,”  
not “Tetrahydrocannabinol” or “Cannabidiol.”  
Page 6 of 8  
10. R420.305(9) further defines the list of legally required cannabinoids for potency testing.  
It is critical that the following points are resolved prior to adoption of the Rule:  
a. Reporting of test results is legally required ONLY for the four entities in items (a) through (f) of  
the subrule as written. This list no longer mandates individually reporting of d9-THC or  
Cannabidiol test results – by default these important compounds fall into optional analyte  
category (E). Omitting mandatory reporting of d9-THC and Cannabidiol test results is not  
recommended.  
b. R420.305(9)(a) and (c) are redundant. R420.305(9)(a) should be changed to “delta-9 THC  
Concentration.”  
c. R420.305(9)(c) defines mandatory compounds that comprise “Total THC.” This definition is  
extremely problematic such that reporting of Total THC results as defined cannot be met at this  
time:  
•
•
Certified analytical reference standards for Delta7-THC (a fully synthetic and non-  
psychoactive cannabinoid) are not commercially available at this time.  
Delta 10-THC (a fully synthetic cannabinoid) certified reference standards are available for  
two separate enantiomers: Delta 10 (6aR, 9S) which is not psychoactive, and Delta 10 (6aR,  
9R) which is psychoactive. The Rule needs to clarify which enantiomer must be quantified.  
“Delta 11” THC is not a recognized term in the current scientific literature. Provided that the  
term intends to describe THC with a double bond between carbon atoms 9 and 11, the correct  
nomenclature is “exo-THC.” This requires clarification in the Rule as certified reference  
standards that are available for this compound are named “exo-THC.”  
•
•
The calculation provided for determining Total THC includes summing the concentrations of  
“Delta 7-11 THCA.”  
This requires a laboratory to individually quantify delta 7, delta 8, delta 10, and delta 11  
THC acids. Certified reference standards for these cannabinoic acids do not currently exist in  
the literature, and the delta-9 THC acid isomers themselves may not be known compounds at  
all at this time.  
It is recommended that this language be revised to allow MRA to publish a list of cannabinoids for  
mandatory testing and reporting and to update the list as needed via bulletins separately from the  
Rules. It is important to address the emergence of additional THC isomers (like delta-8 THC)  
without prematurely and unnecessarily complicating the Rule set.  
11. R420.305(9)(h) does not adequately define reporting units for CBD:  
“For marijuana infused products, potency must be reported in milligrams of Delta-9 THC and CBD.”  
a. While this definition provides a magnitude (milligrams) it does not specify the quantity (per what?).  
Shall the quantity be milliliter of analytical solution, gram of product, serving, etc.? This needs to  
be clarified in the Rule.  
b. This sub-rule conflicts with R420.305(3)(a)(iii) and R420.305(9) in that it requires reporting  
individual test results for Delta 9-THC and CBD for infused products, while these analytes are  
defined as optional in R420.305(3)(a)(iii) and R420.305(9).  
12. R420.305(18) states:  
“A laboratory may perform terpene analysis on a marijuana product by a method approved by the  
agency, and the method must be accredited on the same frequency as all required safety tests. There  
are no established safety standards for this analysis.  
The line that reads “There are no established safety standards for this analysis” should be omitted, as  
safety tests for beverages include a requirement to test for phytol.  
Page 7 of 8  
13. R420.305(21) is not enforceable as written and should not be included in the Rules. Licensed  
laboratories are not equipped to nor otherwise required to identify unknown compounds of any type  
in product samples. In addition “potentially hazardous” and “potentially injurious to human health”  
are ambiguous, as any compound fits these terms” under the right conditions. Consider for example,  
that water is fatal if inhaled, and therefore fits the definition of “potentially hazardous” and  
potentially injurious to human health.”  
14. R420.305(22) conflicts with R420.305(12) and R420.305(13) as it requires reporting of STEC and  
Salmonella “immediately” without defining how that term compares with reporting “within 3 days of  
test completion.” This sub-rule should be omitted.  
15. R420.305a(2) should be revised to read”  
“Laboratories shall use microbial testing methodologies for the required safety tests in subrule  
R420.305 that are sourced from published peer-reviewed methods, have been validated for cannabis  
testing by an independent third party, may be monitored on an ongoing basis by the agency, and  
have been internally verified by the licensed laboratory according to Appendix J of Official Methods  
of Analysis authored by the Association of Official Analytical Collaboration (AOAC) International,  
with guidance from published cannabis standard method performance requirements where  
available. In the absence of published, per-reviewed, validated cannabis methods, method validation  
requirements of Appendix J of Official Methods of Analysis must be met in full with guidance from  
published cannabis standard method performance requirements where available. The agency shall  
approve the validated methodology used by the laboratory and confirm that it produces scientifically  
accurate results for each safety test it conducts. All of the following apply to validated methodologies  
under this rule:”  
(Note: Appendix K is specific to analytical testing and Appendix J is specific to microbial testing.  
16. R420.305b(2)(b) states:  
“To further test the accuracy of the assay, probability of detection (POD) analyses, inclusivity,  
exclusivity, lot-to-lot stability, and robustness studies must be included in validation studies.”  
Lot-to-lot stability testing is not appropriate as a method validation requirement and should be  
removed from this sub-rule. For example:  
•
Stability testing could be conducted on cannabis products. In this case, the stability testing is not  
appropriately included as a test method validation requirement; rather it is a product/ process  
validation item.  
•
Stability testing could be conducted on perishable microbial test reagents. This is a reagent  
manufacturer item, and reagent expiration dates are provided with such reagents, not a method  
validation requirement.  
17. R420.305a(6) states:  
Quality Control acceptance criteria must be published by the agency and be followed. If the method  
acceptance criteria are more stringent, then the method acceptance criteria are (sic) required.”  
This should be changed to read: Quality Control acceptance criteria must be published by the agency  
and be followed. If method-specific acceptance criteria exist, then the method acceptance criteria are  
(sic) required.”  
Quality control acceptance criteria currently published by the agency are known to exceed the  
capabilities of established, industry-accepted test methods, and are more stringent than criteria  
assigned to those methods by the method authors/ innovators.  
Accordingly, this rule will require licensed laboratories with established test methods to abandon  
those methods and seek or develop alternate methods that are likely not available. The cost of this  
may rise to the level that labs will opt to close rather than comply.  
Page 8 of 8  
Website  
www.psilabs.org  
Email  
info@psilabs.org  
Phone  
734.369.6273  
September 27, 2021  
Marijuana Regulatory Agency - Legal Section  
P.O. Box 30205  
Lansing, MI 48909  
Phone: 517-284-8584  
Fax: 517-284-8598  
MRA-Legal@michigan.gov  
SENT VIA EMAIL ONLY  
Re: Comments/Response to MRA Proposed Rules  
Dear Sir or Madam,  
PSI Labs has some recommendations in response to the MRA’s Proposed  
Rules.  
Thank you in advance for your consideration.  
Benjamin J. Rosman  
CEO & Co-Founder, PSI Labs  
Encl:  
_________________________________________________________________________________________________  
PSI Labs – MRA License Numbers: SC-000005, AU-SC-000100  
3970 Varsity Drive, Ann Arbor, MI 48108  
Page 1 of 4  
Website  
www.psilabs.org  
Email  
info@psilabs.org  
Phone  
734.369.6273  
Comments/Response to MRA Proposed Rules  
Sample Size Requirements:  
R. 420.304(2)(b) Except otherwise required by the agency, the laboratory shall  
collect a sample size that is sufficient to complete all required analyses, and not less  
than 0.5% of the weight of the harvest batch.  
The MRA has specified that all compliance flower testing events need to be  
sampled at no less than 0 .5% of the batch, this includes all re-testing.  
Growers that require retesting could easily lose 1.5% or more of their batch for  
testing. We recommend MRA not change its sampling size requirements for flower.  
Potency Adulteration/Manipulation:  
R. 420.305 Testing; laboratory requirements.  
(i) In the preparation of samples intended for potency analysis, the laboratory may  
not adulterate or attempt to manipulate the total potency of the sample by adding  
trichomes that were removed during the grinding and homogenization process.  
(ii) All flower material used for potency testing must be representative of the  
product used by the end consumer and homogenized in such a way that it is  
representative of the way a consumer would be using the product. Kief must not be  
reintroduced to the flower sample during the homogenization process.  
The two guidelines outlined in (i) and (ii) describe methods for a lab to boost the  
potency of a cannabis flower sample. The statements could be combined for  
efficiency. The first statement could also be shortened to say: In the preparation  
of samples intended for potency analysis, the laboratory may not adulterate  
or attempt to manipulate the total potency of the sample by any means. There  
is no need to qualify specific actions that a lab attempting to manipulate the  
potency of a sample might perform, as any process performed by a lab with the  
intention of manipulating the potency is unacceptable and a risk to consumer  
safety.  
Delta 7-11:  
(c) Total THC, which includes Delta 7, Delta 8, Delta 9, Delta 10, and Delta 11 THC  
and THC-A  
Some of these compounds are not readily available to testing laboratories as  
certified reference materials, and requiring labs to test for their presence and  
_________________________________________________________________________________________________  
PSI Labs – MRA License Numbers: SC-000005, AU-SC-000100  
3970 Varsity Drive, Ann Arbor, MI 48108  
Page 2 of 4  
Website  
www.psilabs.org  
Email  
info@psilabs.org  
Phone  
734.369.6273  
abundance in cannabis products is problematic at this time. The current guidelines  
requiring the quantification of Delta 8 and Delta 9 THC are sufficient as of now.  
Delta 8:  
R420.305(9)h For marihuana infused products, potency must be reported as  
milligrams of Delta-9-THC and CBD.  
Milligrams of Delta-8-THC should also be included in the potency reporting  
requirements of a marijuana infused product.  
Reporting Unknown Compounds:  
R420.305(21) A laboratory shall have a policy or procedure in place for handling  
and reporting any potentially hazardous contaminants that may be encountered  
during routine testing. A laboratory shall notify the agency if a test batch is found to  
contain levels of a contaminant that could be injurious to human health.  
Would like to confirm that this revision speaks only to those contaminants for  
which the laboratory is screening or testing, and does not include unknown  
compounds that the laboratory does not test for.  
It is very difficult, if not impossible for a lab to identify unknown potentially  
hazardous compounds through routine analysis. The detection of any compound  
during routine analysis requires that specific parameters are used to ensure the  
identification and quantification of that specific contaminant.  
An alternative interpretation of this rule is that a lab shall have a policy for  
reporting any contaminant found during routine analysis that is over the action  
limits set forth by the MRA (and thus at a level that could be injurious to human  
health). If so, is reporting failures to metrc insufficient and will additional  
notification to MRA required when a contaminant we currently test is present at  
failing levels.  
Restrictions on R&D Testing:  
R 420.307 Research and development testing.  
(7) Research and development testing is prohibited after compliance testing has  
been completed.  
In many cases, a grower with failed flower may want to check if their remediation  
was successful prior to submitting an official re-test. This is not allowed per MRA  
rules, and instead the grower must submit an official .5% sample, potentially  
multiple times until their remediation is successful.  
_________________________________________________________________________________________________  
PSI Labs – MRA License Numbers: SC-000005, AU-SC-000100  
3970 Varsity Drive, Ann Arbor, MI 48108  
Page 3 of 4  
Website  
www.psilabs.org  
Email  
info@psilabs.org  
Phone  
734.369.6273  
No clear reason exists for disallowing R&D testing after compliance testing is  
complete. A license holder should be allowed to R&D test a product at any time  
for any reason, including after the initial compliance testing has already been  
completed.  
We believe R&D testing represents an activity that helps improve the health and  
safety of cannabis products, and should be encouraged - not limited. Those opting  
for R&D testing are looking to improve their products and meet or exceed state  
guidelines. Putting limitations on this activity forces increased levels of market  
manipulations that are unnecessary and do not benefit consumers.  
Aspergillus as Outlier:  
R 420.306 Testing marihuana product after failed initial safety testing and  
remediation. Rule 6.  
(3) Products that failed testing for Aspergillus are ineligible for remediation.  
It is not clear why aspergillus is the sole analyte for which a failed product cannot  
be remediated. This should be removed if there is no justification and clarification  
on why aspergillus presents such a high threat level to consumer safety that it is  
the only analyte failure that makes a product ineligible for remediation.  
The safety concern with aspergillus contamination in cannabis has to do with the  
possibility of opportunistic fungal infections in the lungs of people with  
compromised immune systems from smoking aspergillus contaminated plant  
material. There are a few documented cases of such infections in  
immunocompromised people who were being treated for cancer  
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3103256/).  
However, as the threat is due to opportunistic infection by living aspergillus  
fungus, remediation techniques that kill the aspergillus should be acceptable for  
neutralizing the health risks associated with smoking cannabis flower  
contaminated with this potentially pathogenic organism. Many techniques that are  
used to remediate cannabis flower by reducing or eliminating microbial  
contamination (e.g., treatment with oxidizers, irradiation, solvent extraction, etc.)  
could also be effective at killing aspergillus and therefore eliminating the health  
threat to consumers.  
_________________________________________________________________________________________________  
PSI Labs – MRA License Numbers: SC-000005, AU-SC-000100  
3970 Varsity Drive, Ann Arbor, MI 48108  
Page 4 of 4  
Comments  
R. 420.305 Testing; laboratory requirements.  
Rule 5. (1) A laboratory shall do all of the following:  
R 420.302 Adoption by reference.  
Comment-Remove the costs out for all standards. These may change.  
R. 420.305 Testing; laboratory requirements.  
Rule 5. (1) A laboratory shall do all of the following:  
(a) become fully accredited for all required safety tests in at least 1 required matrix to the  
International Organization for Standardization (ISO), ISO/IEC 17025:2017, by an  
International Laboratory Accreditation Cooperation (ILAC) recognized accreditation body or  
by an entity approved by the agency within 1 year after the date the laboratory license is  
issued and agree to have the inspections, and reports, and all scope documents of the  
International Organization for Standardization made available sent directly to the agency  
from the accrediting body.  
Comment  
agree to have the ISO/IEC 17025: 2017 or latest version assessment report and final certificate directly  
sent to the agency from the accreditation body. (recommend a timeframe is added here). Do you want  
the assessment report and the certificate sent together. When do you want this by?  
Also consider adding the requirement for matrix or analyte additions that is currently being practiced.  
Laboratories shall provide evidence that an assessment is scheduled with their accreditation body in  
order to receive approval from the agency to continue to perform tests.  
(4) All marihuana producers may become certified to GMP by an ISO 17065 accreditation body. This  
accreditation may enable the licensee certain allowances with testing. The agency will publish those  
allowances and information on how to obtain approval for allowances. The standard used for  
certification for GMP must be American National Standards Institute (ANSI) accredited or equivalent.  
(5) All marihuana cultivators may become certified to GACP-GMP by an accrediting body. This  
accreditation may enable the licensee certain allowances with testing. The agency will publish these  
allowances and information on how to obtain approval for allowances. The standard used for  
certification for GACP-GMP must be World Health Organization and American Herbal Products  
Association or equivalent.  
Comment these are conducted by certification bodies recommend to change to  
4) ISO 17065 accredited certification body  
5) change accreditation body to certification body  
Note items 4-5 above may need to be moved to documents related to producers and cultivators.  
Otherwise, these will be overlooked.  
If they want their lab accredited, consider recommending ISO. IEC 17025 accreditation as required for  
compliance safety facilities or they can have their laboratory operation accredited to GMP by an  
accreditation body.  
(14) All laboratories shall participate in the proficiency testing program established by the agency. A  
laboratory shall analyze proficiency test samples from any ISO 17043 accredited vendor on an annual  
basis unless the agency requests additional testing.  
Comment : Recommend changing this to:  
A laboratory shall participate in a third-party proficiency testing with an ISO 17043 accredited provider.  
The proficiency testing provider shall be accredited for all relevant tests required by the agency and by  
an accreditation body recognized under the international laboratory accreditation cooperation (ILAC).  
Submitted By  
Tracy Szerszen, President Perry Johnson Laboratory Accreditation  
9/24/2021  
Draft Rules 2020-124: Marihuana Sampling and Testing  
Viridis Laboratory Comments  
Title  
“Marijuana” is spelled inconsistently throughout this document. It is spelled two different ways  
in the title alone. One spelling should be chosen and used consistently.  
R 420.301 Definitions  
(y) “Pre-testing”. This definition is imprecise. Testing must be repeated sometimes for  
analytical reasons – equipment failure, ambiguous or anomalous results, etc. It would be very  
bad science to insist on results being reported that are uncertain; and whether an analysis should  
be repeated is an operational decision that should be made at the laboratory level. This definition  
should be clarified to exclude retesting for operational or technical reasons.  
(dd) “Target Analyte”  
The definition given is incorrect. A target analyte is something an assay is designed to detect. It  
has nothing to do with the pharmacological activity of the analyte.  
R 420.302 Adoption by Reference  
This entire section appears to direct licensees to purchase pricey documents from the  
organizations listed or from MRA for the same price. If the MRA is adopting these references  
and expecting licensees to adhere to them they should provide these documents to licensees.  
R. 420.303 Batch Identification and Testing  
(6). “After the producer has extracted the material the producer shall have the sample  
tested…” It is unclear what “extracted” means in this context. The previous wording had  
“processed” instead of “extracted”. “Processed” is clearer in meaning and should be retained.  
R 420.305 Testing Laboratory Requirements  
Rule 5 (1) “A laboratory shall become fully accredited for all required safety tests in at  
least 1 required matrix..” “Required matrix” is nowhere defined. There is a list of matrices  
published elsewhere in this document but they do not say which are “required”. Laboratories  
have been approved to test in some matrices but not others in the past. This is unclear and seems  
to add a new layer of regulation without defining it.  
Rule 5 (2). A laboratory shall use analytical testing methodologies for the required safety  
tests in  
subrule (3) of this rule that are validated by an independent third party and may be  
monitored on an ongoing basis by the agency. In the absence of published, peer reviewed,  
validated cannabis methods, Appendix J or K of Official Methods of Analysis authored by  
the Association of Official Analytical Chemists Analytical Collaboration (AOAC)  
International must be published in full with guidance from published cannabis standard  
method performance requirements where available. The laboratory shall obtain approval  
from the agency of its validated methodology, including confirmation that it produces  
scientifically accurate results for each safety test, prior to conducting any safety testing.  
The underlined sentence does not make sense. It states that Appendix J or K must be published  
in full with guidance from performance requirements where available. Presumably MRA means  
to say that requirements listed in Appendix J or K must be met in full but saying they must be  
“published” appears to impute a requirement to submit for publications somewhere. Submission  
to the agency is not the same as “publishing”, as a laboratory’s submission to the agency is not  
meant to be publicly distributed.  
(3) A laboratory shall conduct the required safety tests specified in subdivisions (a) to (i) of  
this subrule on marihuana product that is part of the harvest batch as specified in R  
420.303, except as provided in subrule (4) of this rule. The agency may publish minimum  
testing portions to be used in compliance testing.  
If a method is validated with a specific testing aliquot, arbitrarily specifying that those aliquots  
be changed is not advisable as it could interfere with detection of contaminants of concern.  
Laboratories should use the sample size specified during method validation.  
(i) In the preparation of samples intended for potency analysis, the laboratory may not  
adulterate or attempt to manipulate the total potency of the sample by adding trichomes  
that were removed during the grinding and homogenization process.  
(ii) All flower material used for potency testing must be representative of the product  
used by the end consumer and homogenized in such a way that it is representative of the  
way a consumer would be using the product. Kief must not be reintroduced to the flower  
sample during the homogenization process.  
These two sections are contradictory; and the two sentences in paragraph ii contradict each other.  
Consumers absolutely try to recover kief or trichromes if they grind flower material themselves.  
There are many articles and even Youtube videos demonstrating this. For health and safety  
reasons laboratories should indeed try to obtain a sample representative of what the consumer  
would use or be exposed to, and that involves minimizing loss of trichromes or kief. It makes no  
sense to stipulate that some amount of material should be lost; and begs the question of how  
much “should” be lost and how much “should” be retained. In theory everything should be  
retained.  
(9) Potency shall include the following cannabinoid concentrations listed in subdivisions (a)  
to (f) of this subrule, subject to subdivisions (g) and (h) of this subrule:  
(a) Total THC concentration.  
(b) THC-A concentration.  
(c) Total THC, which includes Delta 7, Delta 8, Delta 9, Delta 10, and Delta 11 THC and  
THC-A. The following calculation must be used for calculating Total THC, where M is the  
mass or mass fraction of delta-9 THC or delta-9 THC-A:  
M total delta-9 THC = M delta-9 THC + 0.877 x M delta-9 THC-A. Σ Delta 7-11 THC + Σ  
((Delta 7-11 THCA) x 0.877)=Total THC  
There are no reference standards available for Delta-7 THC. How does the agency expect  
laboratories to test for this? There are multiple isomers of Delta-10 available. Which does the  
agency wish laboratories to test for? There are no standards available for Delta-11, although  
there are standards for exo-THC. Does Delta-11-THC refer to exo-THC?  
(h) For marihuana infused products, potency must be reported as milligrams of Delta-9-  
THC and CBD.  
Reported as milligrams per what? Dose, package, gram? The original wording had “per serving”  
and “per dose” but this has been removed. It would be better to retain them.  
(16) A laboratory shall not do any of the following: (a) Desiccate samples. (b) Pre-test  
samples. (c) Cherry pick, which means testing specific material from a batch. All sample  
increments must have the same chances of being selected.  
If “Pre-test” means “test more than once”, this can negatively impact the quality of the science  
and is an inappropriate criterion to impose. See also comments under the Definitions section  
above.  
“Cherry pick” is not a scientific term. This is a colloquial term and does not belong in this  
document. “Testing specific material from a batch” is also meaningless. Any material chosen  
could be called “specific material”.  
(21) A laboratory shall have a policy or procedure in place for handling and reporting any  
potentially hazardous contaminants that may be encountered during routine testing. A  
laboratory shall notify the agency if a test batch is found to contain levels of a contaminant  
that could be injurious to human health.  
Please define “potentially hazardous” if by this you mean something other than the target  
analytes compliance testing is required to look for.  
Rule 420.305a Validations  
(2) Laboratories shall use microbial testing methodologies for the required safety tests in  
R 420.305 that are validated by an independent third party and may be monitored on an  
ongoing basis by the agency. In the absence of published, peer reviewed, validated  
cannabis methods, Appendix J of Official Methods of Analysis authored by the Association  
of Official Analytical Collaboration must be published in full with guidance from the  
cannabis standard method performance requirements where available.  
This sentence makes no sense. See comments under 420.305 Rule 5(2) above.  
(d) Microbial methods must include environmental monitoring and quality control of all  
buffers, media, primers, and incubators.  
What does “quality control of buffers, media, primers and incubators” mean?  
R 420.305b Quality assurance and quality control.  
(f) Intra-laboratory comparisons, which involve proficiency testing.  
This should read “inter-laboratory”. Inter-laboratory comparisons are not the same thing as  
proficiency testing.  
(5) A laboratory shall prepare a written description of its quality control activities,  
included as part of a quality control manual. All of the following items must be addressed  
in the quality control manual: (a) Daily, weekly, monthly, and annual requirements. (b) An  
analytical testing batch, which is defined as not more than 20 samples. (c) All analytical  
testing runs must be bracketed with quality controls.  
It is over-reach to specify how many samples must be in any analytical batch. No other  
regulatory agency or accrediting body does this.  
8) All standard operating procedures for the required safety tests in R 420.305 and for  
sampling and testing of marihuana and marihuana products that conform to ISO/IEC  
17025:2017 standards, Good Laboratory Practices, shall be approved by the agency prior  
to the performance of any safety tests. (9) A laboratory shall maintain a quality control and  
quality assurance program that conforms to Good Laboratory Practices and ISO/IEC  
17025:2017 standards and meets the requirements established by the agency.  
Please define what Good Laboratory Practices means. It appears to be something other than  
ISO/IEC 17025:2017. Please provide the reference so labs may know that they are meeting this  
standard.  
R 420.307 Research and development testing.  
(3) Punitive action shall not be taken against a marihuana business for conducting research  
and development testing when permitted.  
This is a tautology.  
(7) Research and development testing is prohibited after compliance testing has been  
completed.  
This appears to forbid producers from trying to improve their products.  
Most of Rule 420.305 appears to be micromanaging of laboratory operations, and an attempt to  
specify details of analysis that are better left to the individual laboratories or should be in the  
technical guidance. Specifying with the force of law how many samples should be in a batch or  
forbidding ill-defined “cherry-picking” is inappropriate regulatory overreach.  
Comments  
R. 420.305 Testing; laboratory requirements.  
Rule 5. (1) A laboratory shall do all of the following:  
R 420.302 Adoption by reference.  
Comment-Remove the costs out for all standards. These may change.  
R. 420.305 Testing; laboratory requirements.  
Rule 5. (1) A laboratory shall do all of the following:  
(a) become fully accredited for all required safety tests in at least 1 required matrix to the  
International Organization for Standardization (ISO), ISO/IEC 17025:2017, by an  
International Laboratory Accreditation Cooperation (ILAC) recognized accreditation body or  
by an entity approved by the agency within 1 year after the date the laboratory license is  
issued and agree to have the inspections, and reports, and all scope documents of the  
International Organization for Standardization made available sent directly to the agency  
from the accrediting body.  
Comment  
agree to have the ISO/IEC 17025: 2017 or latest version assessment report and final certificate directly  
sent to the agency from the accreditation body. (recommend a timeframe is added here). Do you want  
the assessment report and the certificate sent together. When do you want this by?  
Also consider adding the requirement for matrix or analyte additions that is currently being practiced.  
Laboratories shall provide evidence that an assessment is scheduled with their accreditation body in  
order to receive approval from the agency to continue to perform tests.  
(4) All marihuana producers may become certified to GMP by an ISO 17065 accreditation body. This  
accreditation may enable the licensee certain allowances with testing. The agency will publish those  
allowances and information on how to obtain approval for allowances. The standard used for  
certification for GMP must be American National Standards Institute (ANSI) accredited or equivalent.  
(5) All marihuana cultivators may become certified to GACP-GMP by an accrediting body. This  
accreditation may enable the licensee certain allowances with testing. The agency will publish these  
allowances and information on how to obtain approval for allowances. The standard used for  
certification for GACP-GMP must be World Health Organization and American Herbal Products  
Association or equivalent.  
Comment these are conducted by certification bodies recommend to change to  
4) ISO 17065 accredited certification body  
5) change accreditation body to certification body  
Note items 4-5 above may need to be moved to documents related to producers and cultivators.  
Otherwise, these will be overlooked.  
If they want their lab accredited, consider recommending ISO. IEC 17025 accreditation as required for  
compliance safety facilities or they can have their laboratory operation accredited to GMP by an  
accreditation body.  
(14) All laboratories shall participate in the proficiency testing program established by the agency. A  
laboratory shall analyze proficiency test samples from any ISO 17043 accredited vendor on an annual  
basis unless the agency requests additional testing.  
Comment : Recommend changing this to:  
A laboratory shall participate in a third-party proficiency testing with an ISO 17043 accredited provider.  
The proficiency testing provider shall be accredited for all relevant tests required by the agency and by  
an accreditation body recognized under the international laboratory accreditation cooperation (ILAC).  
Submitted By  
Tracy Szerszen, President Perry Johnson Laboratory Accreditation  
9/24/2021  
;