Dykema Gossett PLLC  
Capitol View  
201 Townsend Street, Suite 900  
Lansing, MI 48933  
WWW.DYKEMA.COM  
Tel: (517) 374-9100  
Fax: (517) 374-9191  
R. Lance Boldrey  
Direct Dial: (517) 374-9162  
Direct Fax: (855) 259-3563  
Email: LBoldrey@dykema.com  
February 17, 2020  
Marijuana Regulatory Agency  
Legal Section  
P.O. Box 30205  
Lansing, MI 48909  
Re:  
Comments to Proposed Combined Topic-Based Rule Sets  
To Whom it May Concern:  
As the chair of the Cannabis Law Practice at Dykema, I am writing to offer comments on  
the Michigan Marijuana Regulatory Agency’s (the “MRA”) proposed combined topic-based rule  
sets: Marijuana Licenses; Marijuana Licensees; Marijuana Operations; Marijuana Sampling and  
Testing; Marijuana Infused Products and Edible Marijuana Products; Marijuana Sale or Transfer;  
Marijuana Employees; Marijuana Hearings; Marijuana Disciplinary Proceedings; Industrial  
Hemp for Marijuana Businesses; and Medical Marijuana Facilities (Rescinded) (collectively  
referred to as the “Proposed Rules”) being promulgated pursuant to the Medical Marihuana  
Facilities Licensing Act (“MMFLA”) and the Michigan Regulation and Taxation of Marihuana  
Act (“MRTMA”).  
As you know, our attorneys and government policy advisors represent clients in all facets  
of the medical and adult use cannabis industry. Our comments are based on our collective  
experience and the experience and views of many of our clients. Pursuant to the rulemaking  
process and the request for public comments, please find below Dykema’s comments and  
recommendations on the proposed rules.  
1. General Global Comments  
Although most of our comments are targeted to isolated provisions within the Proposed  
Rules, and are set forth below on a rule by rule basis, two of our comments implicate issues that  
are reflected by multiple proposed rules.  
First, as a general matter, all provisions related to Labor Peace Agreements should be  
eliminated. A mandate to enter into Labor Peace Agreements as a condition of licensure violates  
the National Labor Relations Act (“NLRA”) and exceeds the statutory authority given to the  
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Department. Additionally, Labor Peace Agreements effectively place the terms and conditions  
of employment in the hands of an arbitrator. In an industry that is just beginning to find its way,  
and where income and expenses already fluctuate wildly, requiring critical economic decisions  
to be made by a third party does nothing to protect the interests of the industry, patients,  
consumers, and the state. Therefore, all provisions related to Labor Peace Agreements should be  
removed in entirety from all rule sets.  
Second, we believe that there should be significant rewrites of the testing provisions. We  
have already seen instances where MRA has imposed new standards and ordered hundreds of  
thousands of dollars of product to be destroyed, only to then realize that the standards were  
flawed or should be implemented differently, and reverse course. Producers who were ordered  
to destroy product that MRA later determined was not harmful have suffered significant  
economic harm with no recompense. We believe these concerns are best addressed by allowing  
greater flexibility when it comes to remediation and by broadening the concept of administrative  
holds beyond simply cases of rules violations, to also encompass product that has initially failed  
testing. This would provide producers the ability to contest the appropriateness or sufficiency of  
testing standards without having to destroy viable product.  
Third, we believe that the MRA should exercise its authority to establish new license  
types to establish a license for receiver businesses. As we have learned from other states, we  
should expect significant business failures in this industry. Yet, cannabis businesses cannot avail  
themselves of federal bankruptcy protection. Additionally, MRA’s rules provide for the  
suspension and revocation of licenses. In an industry where licensees may have product  
midstream in growth or production, or significant inventories, suspending operations can lead to  
significant loss, and jeopardize the interests of creditors. This can also incentivize product  
diversion. Having licensed receivers able to step in to operate or liquidate facilities serves  
numerous public interests.  
2. Marijuana Licenses 2019-67 LR  
R 420.1(1)(c)—Definition of “Applicant”  
The term “indirect ownership interest,” used in 420.1(1)(c)(i), comes directly from the  
MMFLA but was not defined by the Legislature, leading to confusion and inconsistent practice  
and advice from attorneys in the industry. The Proposed Rules should either define the term or  
state that MRA will provide guidance as to the MRA’s interpretation. We often see what may be  
considered indirect interests arise through the provision of equity in only one license of an entity  
that possesses multiple licenses, or with respect to one product line. Today, it is not clear if an  
indirect interest of 10% should be calculated based on total equity, total revenues, or some other  
metric. MRA guidance would be useful.  
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Also, we appreciate the express permission for both financing arrangements and licensing  
agreements. Under 420.1(1)(c)(ii)(A) and (D), however, we recommend defining the terms  
“reasonable interest rate” and “reasonable payment,” respectively. At a minimum, the rules should  
state that MRA will provide guidance to the industry with respect to these terms.  
R 420.1(1)(l)—Definition of “Employee”  
Under 420.1(1)(l), the definition of “Employee” excludes “individuals providing trade  
services who are not normally engaged in the operation of a marihuana business.” Dykema  
suggests that the language read “Employee” does not include “individuals providing trade or  
professional services who are not normally engaged in the operation of a marihuana business.  
R 420.3—Application procedure; requirements  
Under 420.3(2), Dykema suggests allowing prequalification status for grow facilities  
currently under construction to extend beyond 1 year to avoid having to re-qualify grow facilities  
whose municipal approval process and construction schedule often extends far beyond that  
timeframe. This is especially problematic when a municipality requires prequalification status as  
a condition to local approval, and prequalification status could be temporarily lost. Dykema  
suggests providing that the MRA may request updated information from an applicant within 90  
days prior to the expiration of prequalification status, and allow applicants with their facility under  
construction to maintain uninterrupted prequalification status so long as circumstances have not  
changed in a manner that affects suitability.  
R 420.4—Application requirements; financial and criminal background  
Under 420.4(2)(a)(i)(C), Dykema suggests amending the language “all loans” to read “all  
loan types specified by the Department,” thus providing explicit authority for the MRA to exclude  
auto loans, credit cards, student loans or other loans that the MRA may find to be unnecessary to  
examine.  
Under 420.4(13), while we understand the need to have adult-use licensees pass a facility  
inspection on a timely basis, we also believe that this requirement provides municipalities the  
ability to sidestep important MRTMA protections, at least insofar as MRA requires local  
certificates of occupancy as a condition for passing inspection. As you know, MRTMA provides  
municipalities the ability to opt out of allowing adult use businesses in their communities, but  
MRTMA also explicitly states that ineligibility of an applicant to receive a license on this basis  
must be tested as of the time the applicant files its application. MRTMA also expressly provides  
that a municipal ordinance may not prevent an applicant from operating certain types of adult-use  
establishments where the applicant already has an operating MMFLA facility. Despite the fact  
that MMFLA and MRTMA operations and impacts are identical in nature (indeed, for many  
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license types the only observable difference is the color of the Metrc tag), we have seen  
municipalities refusing to issue certificates of occupancy for adult-use purposes to existing medical  
facilities. A licensee should have the ability to demonstrate to MRA that a municipality is  
improperly withholding documentation, without being forced to suffer a license denial and then  
sue either the MRA or the municipality.  
R 420.5—Application requirements; complete application  
Under 420.5(4)-(5), Dykema suggests allowing more than 5 days for applicants to supply  
missing information or proof of corrected deficiencies to the agency, at least in the case of  
MMFLA applicants for whom there is no 90-day deadline for MRA decision making.  
R 420.10—Proof of financial responsibility; insurance  
Dykema suggests adding language to sections (1) and (4) that would require licensees to  
maintain $100,000 in liability insurance per location as opposed to per license.  
R 420.11—Capitalization requirements; medical marihuana facilities licensing act  
Dykema suggests amending section (1) to read “On its initial application for licensure  
under the medical marihuana facilities licensing act, an applicant shall disclose the sources and  
total amount of capitalization to operate and maintain a proposed marihuana facility.” In other  
words, the capitalization requirements should not be applicable to the expansion of existing  
facilities.  
R 420.12—Denial of a marihuana license; additional reasons  
Dykema suggests that 420.12(2)(e) and (n) apply to adult-use applicants only, as they again  
stem from the MRA’s need to more quickly process adult-use applications.  
R 420.13—Renewal of state license  
Under section (1)(a) and (2) the MRA is requiring spouses on renewal applications to be  
fingerprinted, and apparently treating a disqualified spouse as a basis to disqualify an entity on  
renewal. This applies new “applicant” language from 2018 statutory amendments to both initial  
applicants and renewals. We believe this is entirely contrary to legislative intent and to the  
language of the MMFLA.  
The original set of amendments proposed by LARA/BMMR in 2018 made the  
definitional change equally applicable to those in the application process and those who had yet  
to file. This caused a particular concern by essentially retroactively changing the standard for  
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those who had already filed applications. More specifically, this caused specific concerns for  
applicants who worked with Rep. Kesto to ensure the changes would not be retroactively  
applied; this was the genesis of the language limiting the effectiveness of the change to only  
applications submitted “on or after January 1, 2019.” To now include and enforce these  
standards on renewal to entities that applied before January 1, 2019, would completely subvert  
and undermine the Legislature’s intent in adding the January 1, 2019, language.  
Additionally, to add these requirements on renewal is inconsistent with the statutory language  
itself. The MMFLA, as amended, makes an express distinction between “Applicant” and  
“Licensee” under the MMFLA, as amended, along with a possible argument about MRA not  
properly exercising its deference when carrying out the MMFLA depending on its ultimate  
position. The MMFLA has specifically defined both “Applicant” and “Licensee” and references  
the various definitions based on whether the license is being applied for or whether it is being  
renewed. Thus, an “Applicant” is not a “Licensee” and a “Licensee” is not an “Applicant.”  
Michigan courts have continuously held that “[w]hen interpreting a statute, our primary  
obligation is to ascertain and effectuate the intent of the Legislature. To do so, we begin with the  
language of the statute, ascertaining the intent that may be reasonably inferred from its  
language.” Lash v Traverse City, 479 Mich 180, 187 (2007). “When the language of a statute is  
unambiguous, the Legislature’s intent is clear and judicial construction is neither necessary nor  
permitted.” Id. The Michigan Supreme Court has further held that “ambiguity is a finding of last  
resort.” Stone v Williamson, 482 Mich 144, FN 21 (2008).  
The MMFLA defines “applicant” as “a person who applies for a state operating license.” MCL  
333. 27102(c). The statute further clarifies that applicant includes, “with respect to disclosures  
in an application, for purposes of ineligibility for a license under section 402, or for purposes of  
prior board approval of a transfer of interest under section 406, and only for applications  
submitted on or after January 1, 2019, a managerial employee of the applicant, a person holding  
a direct or indirect ownership interest of more than 10% in the applicant.” Id. The MMFLA  
defines “Licensee” as “a person holding a state operating license.” MCL 333.27102(j).  
MCL 333.27402 provides that “[t]he board shall issue a license to an applicant who submits a  
complete application and pays both the nonrefundable application fee required under section  
401(5) and the regulatory assessment established by the board for the first year of operation, if  
the board determines that the applicant is qualified to receive a license under this act.” MCL  
333.27402(1). Section 27402 further provides that “[a] license shall be issued for a 1-year period  
and is renewable annually. Except as otherwise provided in this act, the board shall renew a  
license if all of the following requirements are met: (a) The licensee applies to the board on a  
renewal form provided by the board that requires information prescribed in the rules; (b) The  
application is received by the board on or before the expiration date of the current license; (c)  
The licensee pays the regulatory assessment under section 603; and (d) The licensee meets the  
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requirements of this act and any other renewal requirements set forth in the rules.” MCL  
333.27402(9).  
From the statutory language it is apparent that the Legislature intended to distinguish applicants  
(persons applying for a state license) and licensees (persons holding a state license). Section  
27402 outlines the requirements for applicants to obtain a license, throughout the entire section  
pre licensure requirements are referred to by “applicant.” However, provisions outlining the  
requirements for licensure renewal specifically reference the “licensee.” Thus, the Legislature  
intended that the definition of applicant apply to only those seeking licensure, while the  
definition of licensee refer to holders of licenses.  
Dykema suggests adding qualifying language to section (1)(a) and (2) carving out an  
exception for spouses of applicants and licensees whose original application was filed prior to  
January 1, 2019.  
R 420.21—Designated consumption establishment license  
Dykema suggests adding “program or manual” to section (2)(k) to read: “A documented  
employee training program or manual that addresses all components of the responsible  
operations plan.”  
R 420.27—Marihuana delivery business  
Dykema recommends removing rule 420.27 in its entirety. Licensees who make  
significant investments in facility construction, inventory, and operating costs have a meaningful  
financial incentive to fully comply with statutory and regulatory obligations. A licensee who  
makes no such investment and has a role simply limited to delivering retail product does not  
have such incentives. This new license type simply presents too much risk.  
3. Marijuana Licensees 2019-68 LR  
R 420.108—Grower license  
Under section (6), Dykema suggests defining “investor.”  
R 420.109—Processor license; exception for industrial hemp  
Under section (1), Dykema suggests re-wording the section to read “A processor license  
authorizes purchase of marihuana only from a grower or another processor.” Currently, the  
section allows the sale of marihuana from another processor but not the purchase. If the sale is  
authorized to another processor, it is inherent that the purchase would also be allowed. (We note  
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also that the title of this rule includes “exception for industrial hemp,” yet the rule does not  
mention hemp.)  
4. Marijuana Operations 2019-69 LR  
R 420.201—Definitions  
Under 420.201(1)(c), Dykema suggests extending the definition of Administrative Hold to  
include the failure to meet testing standards, and allow facilities having product that fails testing  
standards to hold the product during an investigation into alleged violations or sufficiency of  
testing standards.  
Under 420.201(1)(e)(ii)(D), the MRA should define what is a “reasonable payment”  
under a licensing agreement.  
R 420.203—Marihuana licenses; licensees; operations; general  
420.203(2)(a) provides that “a marihuana business shall be partitioned from any other  
marihuana business or activity, any other business, or any other dwelling.” While section (2)(a)  
provides an exception for operation of separate licenses at the same location and for operation of  
equivalent licenses at the same location, we believe that the current language does not fully  
contemplate the processing of industrial hemp. Section 7(1) of the Industrial Hemp Research  
and Development Act (the “Hemp Act”) states that a processor licensed under the MMFLA may  
process industrial hemp. Therefore, we believe that language should be added at the end of  
section (2)(a) of proposed rule 420.203 to read “a marihuana business shall be partitioned from  
any other marihuana business or activity, any other business, or any other dwelling, other than  
activities in which marihuana businesses are entitled to participate, and provided further that  
growers and processors operated at the same location under R 420.204 shall not be required to  
partition.” (This latter provision would eliminate the need for costly “mantraps” in co-located  
and integrated grower and processor facilities.)  
Although the language of 420.203(2)(c) appears in the current rules, we believe that the  
MRA should remove the requirement that marihuana businesses must be contiguous. To date,  
MRA has allowed licensed activities to be in out-buildings on the same parcel as primary  
buildings (e.g., for grinding of waste). At a minimum, the MRA should at least define  
contiguous to mean structures located on one parcel.  
Dykema suggests removing the prohibition against drive through operations in  
420.203(2)(g).  
R 420.204—Operation at same location  
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Dykema suggests amending 420.204(2)(d)(iii) to read “Have separate entrances, exits,  
inventory, record keeping, and point of sale operations other than for growers and processors at  
the same location.”  
As noted above, in 420.204(2)(d)(ii) MRA should remove the requirement that marihuana  
businesses must be contiguous.  
Dykema suggests adding a subsection (4)(d) under 420.204 that makes clear that a  
laboratory co-located with an existing non-marijuana testing laboratory must comply with all  
building security, design, and other MRA operational rules.  
R 420.205—Equivalent licenses; operation at same location  
Under 420.205(2)(c) to operate equivalent licenses at the same location, the operation  
cannot “circumvent a municipal ordinance or zoning regulation that limits the marihuana business  
under the acts.” MCL 333.27956, however, provides that “[a] municipality may not adopt an  
ordinance that . . . prohibits a marihuana grower, a marihuana processor, and a marihuana retailer  
from operating within a single facility or from operating at a location shared with a marihuana  
facility operating pursuant to the medical marihuana facilities licensing act.” Dykema suggest that  
this exact language be added to the end of (2)(c) after a “provided, however,” in order to comply  
with the statutory requirements and prevent municipalities from sidestepping them.  
R 420.206—Marihuana business; general requirements  
Under 420.206(1)(b)(ii), cultivation may occur outdoors if “all drying, trimming, curing,  
or packaging of marihuana occurs inside the building meeting all the requirements under these  
rules.” Dykema suggests adding “Provided, however, that marihuana may be transported to a  
grower or processor without drying, trimming, curing, or packaging of marihuana.”  
Under 420.206(8)(b), Dykema suggests defining the term “supervisory analyst.”  
Under 420.206(11), the term ‘inactive ingredients’ is a pharmaceutical product term.  
While the term and this requirement is sensible with respect to distillate blended with other  
products and intended for inhalation through vaping, to the extent that edibles or other supplements  
have ingredients that may be on the FDA inactive ingredient list, they are not intended to “facilitate  
the transport of marihuana in the body” and therefore the regulation makes no sense as applied to  
edible or ingestible marihuana products. As non-pharma products or supplements, such products  
should simply be required to list the ingredients pursuant to FDA labeling regulations (for food  
products).  
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420.206(14) requires marihuana businesses to comply with updated standards issued by  
the agency within 60 days of their adoption. However, for growers, 60 days does not provide  
enough time for a grow cycle to occur and product to be tested to comply with any changes.  
Therefore, Dykema suggests adding “Except in cases of public health emergencies, a lab must  
validate new tests within 60 days of adoption by the agency and growers and processors must meet  
the standards adopted by the agency within 150 days of adoption.”  
420.206(16)(a)-(b) quite simply amounts to a regulatory taking and must be removed. The  
agency has no statutory authority to force a sale of product to a third party “to ensure that all  
marihuana businesses are properly serviced.” Such a regulation amounts to a regulatory taking  
and forces marihuana businesses to eliminate their competitive business advantage. By mandating  
sales in certain circumstances, it also puts the MRA itself in direct violation of the federal  
Controlled Substances Act, eliminating the defense to pre-emption challenges to the MMFLA  
(and, by extension, to MRTMA) relied upon by the Michigan Supreme Court in Ter Beek v City  
of Wyoming, 495 Mich 1 (2014). This step would thus threaten to undermine Michigan’s entire  
statutory framework for the industry.  
R 420.207—Marihuana delivery; limited circumstances  
Under 420.207(3), Dykema suggests changing “shall establish procedures” to “may  
establish procedures.” (Otherwise, this could be read as mandating delivery for businesses that  
may choose not to engage in this practice.)  
Under 420.207(4)(c), Dykema suggests amending the language to read: “All marihuana  
delivery employees meet the requirements in R 420.602 and are employees, as defined in R  
420.601(1)(d), of the marihuana sales location.  
R 420.208—Building and fire safety  
Under 420.208(5), we believe that the MRA and Bureau of Fire Services needs to re-assess  
whether growers should be treated as an industrial use. This unique Michigan treatment has led to  
numerous requirements that are not present in any other state, including such absurdities as  
mandating sprinklers and specific paths and distances for marijuana planted outdoors under plastic  
high tunnels.  
R 420.209—Security measures; required plan; video surveillance system  
Under 420.209(3) Dykema suggests adding “or other electronic or keypad access” after  
“door locks.” (The current mandate for commercial grade locks has been interpreted by some in  
MRA Enforcement to require low-tech deadbolt style locks, when electronic access controlled  
doors are more secure.)  
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5. Marijuana Sampling and Testing 2019-70 LR  
R 420.301—Definitions  
Under 420.301(1)(h) “Final Package” is defined as “the form a marihuana product is in  
when it is available for sale by a marihuana sales location.” We believe the definition is  
ambiguous because it references the “form” of the product itself. The definition should reference  
the packaging, not the form of the product. Therefore, we suggest the definition be amended to  
read: “Final Package means the outermost container or box the marihuana product is house in  
when it is available for sale by a marihuana sales location.”  
R 420.303—Batch; identification and testing.  
Dykema suggests that MRA clarify in 420.303(1) that each immature plant counts as one  
plant toward the grower plant count. As the MRA and others have determined, this is the count  
methodology required by the wording of the MMFLA. However, this provision for batch  
tagging in Metrc, while correct, continues to be misinterpreted, especially by new market  
entrants.  
420.303(5) currently allows marihuana product that fails testing and is remediated to be  
sold or transferred once approved by the agency. We believe that agency approval should not be  
required for marihuana product that passes (under R 420.306) two subsequent re-tests following  
remediation.  
Under 420.303(9), the MRA should change the language “anytime the marihuana product  
changes form” to read “anytime the marihuana product changes state.”  
R 420.304—Sampling; testing  
Under 420.304(2)(b)-(c), the MRA should amend section (2)(b) to read “The agency may  
publish sample sizes for other marihuana products being tested, and may provide for a  
maximum harvest batch size.” Additionally, the MRA should move the language at the end of  
section (2)(c) to the end of (2)(b) to now read “The laboratory must have access to the entire  
batch for the purpose of sampling and shall ensure that the sample increments are taken from  
throughout the batch.” (Sampling methodology should remain under the full control of the  
laboratory, not growers, and growers should not be held responsible for a laboratory’s failure to  
take appropriate samples.)  
In 420.304(2)(h), laboratories should be the parties responsible for uploading accurate  
data from the certificate of analysis into the statewide monitoring system. Certificates of  
analysis are not standardized, vary from lab to lab, and are commonly misunderstood.  
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Dykema suggests amending 420.304(2)(i) to read “This provision does not apply to a  
laboratory who engages another laboratory to perform certain safety tests on a subcontracted  
basis, or to a laboratory under common ownership.”  
R 420.305—Testing; laboratory requirements  
420.305(3) should be clarified so as to not interpret the section to mean a marihuana  
product needs to be tested every time it changes form (or state). Testing should be required  
before sale or transfer, but not when form changes due to processing.  
420.305(10) currently sets a zero tolerance for chemical residue (pesticides). However,  
extremely low levels of pesticide residue is possible. We believe that chemical residue should  
have an action limit instead of a limit of quantification. Having an LOQ with a fail for even the  
slightest amount of chemical residue creates excess costs or production because potentially large  
batches must then be destroyed. At the very minimum we believe that R 420.306(3) should be  
amended to allow product that tests positive for chemical residue to be remediated to fall below  
the action limit allowable.  
We believe that the accuracy thresholds for all licensed labs should be published by the  
department. This would allow other licensees to monitor and be aware of labs that are the most  
accurate.  
The MRA should add a 420.305(2) stating that, “A marihuana business may have a failed  
batch R&D tested by a different laboratory to determine whether or not the laboratory that  
performed the initial test may have made an error. If an R&D test contradicts the failed result,  
the department will investigate the failed result and may have the item selected for random  
sampling by another licensed lab.”  
Finally, Dykema suggests adding a provision to Rule 420.305 that allows laboratories  
prelicensure possession of marihuana for the purpose of validating testing equipment. (With the  
passage of MRTMA, owners and operators of prelicensed laboratories have the legal authority to  
possess marijuana.)  
R 420.306—Testing marihuana product after failed initial safety testing and remediation  
Dykema suggests amending 420.306(2) to add a provision that prevents immediate  
destruction of product if the marihuana business is challenging the validity of testing. In this  
case, product would be required to be placed under an administrative hold as defined in R  
420.501.  
As discussed above, 420.306(3) is not ideal in practice. Currently, the rules propose a  
zero tolerance for chemical residue. However, ultra-low levels of chemical residue can be  
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attributable to accidental contamination rather than the use of a banned pesticide. Section (3)  
should be amended to allow processors to remediate the material to remove chemical residue.  
The implementation of the current section, as written, will result in exponential loses to licensees  
and a shortage of product for customers and patients. Growers are vulnerable to large losses as a  
result of accidental environmental contamination, while processors are vulnerable to large losses  
due to an accumulation of contamination during processing, even where no banned pesticide was  
utilized.  
420.306(4) should be amended to specify that processors will be allowed to remediate  
any material that can be remediated. Additionally, this rule should allow processors to transfer  
material to another processor for remediation.  
Finally, Dykema suggests amending section (4) to read “The agency shall publish a  
remediation protocol.”  
R 420.307—Research and Development  
We believe that R&D testing should be allowed before or after final compliance testing.  
6. Marijuana Infused Products and Edible Marijuana Product 2019-71 LR  
R 420.403—Requirements and restrictions on marihuana-infused products; edible marihuana  
product  
420.403(6) should be amended in accordance with our comment to R 420.206(11): The  
term ‘inactive ingredients’ is a pharmaceutical product term. To the extent non-medical  
marihuana products have ingredients which may be on the FDA inactive ingredient list, they are  
not intended to “facilitate the transport of marihuana in the body” and therefore the regulation  
makes no sense as applied to edible or ingestible marihuana products. As food or supplements,  
such products would be required to list the ingredients pursuant to FDA labeling regulations.  
R 420.404—Maximum THC concentration for marihuana-infused products  
420.404 should be amended to read “A marihuana sales location shall not sell or transfer  
marihuana infused products that exceed, by more than 15%, the maximum THC concentrations  
established by the agency.”  
7. Marijuana Sale or Transfer 2019-72 LR  
R 420.504—Marihuana product sale or transfer; labeling and packaging requirements  
California | Illinois | Michigan | Minnesota | Texas | Washington, D.C.  
071889.000098 4815-4954-6932.3  
Marijuana Regulatory Agency  
February 17, 2020  
Page 13  
Under 420.504(1)(i), listing the name of the laboratory that performed any test, any  
associated batch number, and any test analysis date is very cumbersome and should be limited to  
certain laboratories, batch numbers, and analysis dates.  
Under 420.504(1)(k)(iii), Dykema suggests amending the language to read: “For products  
being sold by a licensee under the medical marihuana facilities licensing act that exceed  
maximum THC levels allowed for products sold under MRTMA, “For use by individuals 21  
years of age or older only. Keep out of reach of children.”  
Additionally, under section (1)(k)(iv), Dykema suggests amending the language to read:  
“For all other products being sold by a licensee, “For use by individuals 21 years of age or older  
or registered qualifying patients only. Keep out of reach of children.”  
Together, the above changes would enable licensees to use the same labels for products  
that are allowed for both medical and adult-use customers, thereby reducing the costs incurred by  
growers and processors.  
R 420.505—Sale or transfer; marihuana sales location  
Dykema suggests amending section (1)(e) to read “A licensee selling marihuana product  
pursuant to the medical marihuana facilities licensing act.”  
R 420.507—Marketing and advertising restrictions  
Under 420.507(6), Dykema suggests moving “under the medical marihuana facilities  
licensing act” to after “marihuana product” so that section (6) would read: “A marihuana product  
under the medical marihuana facilities licensing act must be marketed or advertised as  
‘medical marihuana’ for use only by registered qualifying patients or registered primary  
caregivers.”  
Under 420.507(7), Dykema suggests moving “under the medical marihuana facilities  
licensing act” to after “marihuana product” so that section (7) would read: “A marihuana product  
under the medical marihuana facilities licensing act must not be marketed or advertised to  
minors aged 17 years or younger.”  
8. Marijuana Employees 2019-73 LR  
R 420.602—Employees; requirements  
Dykema suggests amending sections (6) and (7) to insert “or professional” after the word  
“trade”.  
California | Illinois | Michigan | Minnesota | Texas | Washington, D.C.  
071889.000098 4815-4954-6932.3  
Marijuana Regulatory Agency  
February 17, 2020  
Page 14  
9. Marijuana Hearings 2019-74 LR  
R 420.706—Complaint by licensee  
Dykema suggests adding a section that allows licensees to contest the standards set for  
testing.  
10. Marijuana Disciplinary Proceedings 2019-75 LR  
R 420.808—Citation  
Dykema suggests amending section (7) to allow a licensee to provide “a written  
response” instead of limiting the response to one single page.  
11. Industrial Hemp Rule for Marihuana Businesses 2019-88 LR  
R 420.1003—Processing industrial hemp.  
Sections (1), (2) and (5) of 420.1003 expressly require a medical or adult-use marijuana  
processor to comply with the Hemp Act and associated rules promulgated by the Michigan  
Department of Agriculture and Rural Development if the processor handles, processes, markets,  
or brokers industrial hemp. This would pose a serious compliance issue for marijuana processors  
that choose to process industrial hemp for several reasons. First and foremost, industrial hemp and  
marijuana are both defined as the plant Cannabis sativa L., with the only distinction between the  
two being the delta-9-tetrahydrocannabinol (THC) concentration of the plant. Under the Hemp  
Act, any cannabis in the processor’s possession that exceeds .3% THC concentration would be  
considered non-compliant industrial hemp and would need to be destroyed. Thus, a marijuana  
processor that processes both industrial hemp and marijuana would not be in compliance with the  
Hemp Act because it would be processing and in the possession of cannabis with a THC  
concentration that exceeds the allowable limit under the Hemp Act. Similarly, a marijuana  
processor would be unable to use any industrial hemp-derived CBD or other ingredients in its  
finished marijuana products.  
Therefore, the rule should be clarified to exempt marijuana processors from complying  
with the Hemp Act if and when the marijuana processor handles, processes, markets, or brokers  
cannabis with a delta-9-THC content greater than 0.3% on a dry weight basis.  
California | Illinois | Michigan | Minnesota | Texas | Washington, D.C.  
071889.000098 4815-4954-6932.3  
Marijuana Regulatory Agency  
February 17, 2020  
Page 15  
Regards,  
DYKEMA GOSSETT, PLLC  
R. Lance Boldrey  
California | Illinois | Michigan | Minnesota | Texas | Washington, D.C.  
071889.000098 4815-4954-6932.3  
Draft Rules Comments 2.10.20  
We commend and agree with the following proposed changes:  
Unlimited remediation and testing on final product  
6 month lead time on implementing changes to testing protocols  
Common definitions  
Independent, third-party consultation and confirmation of new testing protocols  
Our feedback and proposed recommendations:  
R 420.504  
Rule 4. 1. (i) Name of the laboratory that performed any test, any associated test batch number,  
and any test analysis date  
Comment: Written in a way that would require any future test dates to be affixed to the products.  
The Issue with this is if products are at a retailer and the processor has additional tests run  
(such as what happened with additional Vitamin E tests) retailers will defer to the processor who  
would have this info, but if it’s already in the retailer’s METRC system the processor is locked  
out of this information.  
Recommendation: Tests done to product batches after they have been sold to provisioning  
centers do not need amended stickers.  
R 420.507  
Rule 7 (5) A person receiving reasonable payment under a licensing agreement or contract  
approved by the agency concerning the licensing of intellectual property, including, but not  
limited to, brands and recipes, is responsible for any marketing or advertising undertaken by  
either party to the agreement.  
Comment: This adds undo stress on distributors, making it difficult for brands to move into the  
licensed market. Processors can’t be held liable for the choices and spending habits of out of  
state partners.  
Recommendation: If there is reasonable evidence that processors did were not aware of  
marketing campaigns that are non-compliant, they may appeal.  
R 420.705  
Rule 5. (1) If the agency summarily suspends a marihuana license without notice or hearing  
upon a determination that the safety or health of patrons or employees is jeopardized by  
continuing the marihuana business’s operation, a post-suspension hearing must be held  
promptly to determine if the suspension should remain in effect, in accordance with section 92  
of the administrative procedures act, MCL 24.292, and MAHS general hearing rules.  
Comment: If a licensee has their license suspended improperly, they are being caused an undo  
amount of stress with no foreseeable time limit in which their business will be shut down.  
Recommendation: Ensure the issue will be reviewed within 3 days of suspending the license to  
ensure prompt response.  
R 420.803  
Rule 3. (1) ...Any material change or modification to the marihuana business must be approved  
by agency before the change or modification is made  
Comment: Unclear about what kind of changes need to be reported  
Recommendation: Define “material change”, possibly with a monetary threshold for reference.  
R 420.404  
Rule 4. A marihuana sales location shall not sell or transfer marihuana infused products that  
exceeds the maximum THC concentrations established by the agency. For the purposes of  
maximum THC concentration for marihuana infused products, the agency shall publish a list of  
maximum THC concentrations and serving size limits  
Comment: This does not explicitly account for variability due to the lack of precise testing  
availability. For example, an infused product could have 100mg of THC which is the maximum  
allowable, but due to the margin of error in testing, the tests can report THC levels at 115mg,  
and lead to the unnecessary destruction of product.  
Recommendation: Allow a +/- 15% THC limit to account for testing variance.  
R420.1  
C) i. “Managerial Employee”  
Comment: “Managerial employees” are considered applicants, and must be disclosed to the  
state and thoroughly vetted. While it is understandable that this information be disclosed to the  
state for majority owners, the term “managerial employee” leaves room for confusion and error  
in the application and renewal process. Additionally, “managerial employee” can easily be  
confused with “managers” who are typically general administrators and have no ownership  
interests but oversee employees and operations.  
Recommendation: The term “applicant” should only refer to those who have above 10% vested  
ownership in the company. The term “managerial employee” should not be used.  
R 420.6  
“Marijuana Delivery Business”  
Comment: Allowing for standalone “Marijuana Delivery Businesses” is a threat for to the entire  
licensed industry and helps strengthen and allow for easier access to the black market. Nothing  
will prevent a “Marijuana Delivery Business” from smuggling black market contraband into the  
licensed market while they make deliveries. Established marijuana retailers who provide home  
delivery have their license and entire brick and mortar operation and investment at risk, whereas  
a “Marijuana Delivery Business” has the cost of the license ($4,000) and the investment of the  
delivery vehicles at risk. This license is a threat to the public health and safety of our  
communities.  
Recommendation: Do not allow for standalone “Marijuana Delivery Businesses”  
420.206  
(b) (i) The outdoor area containing the cultivation of marihuana plants is contiguous with the  
building, fully enclosed by fences or barriers that block outside visibility of the marihuana plants  
from the public view, with no marihuana plants growing above the fence or barrier that are  
visible to the public eye, and the fences are secured and comply with the applicable security  
measures in these rules, including, but not limited to, locked entries only accessible to  
authorized persons or emergency personnel.  
Comment: Outdoor grows are the most needed for stabilizing the industry. However, it is  
virtually impossible on many properties to completely block outside visibility of the marijuana  
plant due to the plants’ possible heights and dips and valleys in properties. Outdoor grows will  
be the key in the industry rebounding from the caregiver cutoff. Outdoor grows are needed to  
produce distillate that previously would’ve been purchased from caregivers. Removing this  
requirement greatly increases the properties that can be feasibly used as outdoor  
grows. Moreover, because marijuana is indistinguishable from hemp when grown outdoors,  
removing the barriers and walls will make it less of a target, and not more of one.  
Recommendation: Remove “block outside visibility of the marihuana plants from the public view”  
R420.301  
(g) “Final Package”  
Recommendation: Products in their “Final Package” should be tested as such. Processors  
should not need to have every stage of a product tested, in addition to testing in its final product.  
This change would save time and money for processors without compromising the safety of  
patients. The greatest risk and liability would also be on the processor, as tainted distillate or  
other raw ingredients would cause the item in final packaging to fail, rendering it unusable and  
the entire process  
R 420.403(10) [Product Expiration Dates]  
(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 shelf  
stable 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. 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 new label with a later expiration date.  
Comment: The old language included more of a “best by” date that permitted sale after the best  
by date. Deletion of the language: “or a use-by date, upon which the marihuana product is no  
longer optimally fresh” presumably requires destruction after that date.  
Recommendation: I’ll lean on the manufacturing experts for a recommendation.  
R 420.506 [Monthly v Rolling Calendar Days]  
(2) Before the sale or transfer of marihuana product to a registered qualifying patient or  
registered primary caregiver, under the medical marihuana facilities licensing act, the licensee  
shall verify in the statewide monitoring system that the sale or transfer does not exceed the  
monthly purchasing limit of 10 ounces of marihuana product per month to a qualifying patient,  
either directly or through the qualifying patient’s registered primary caregiver.  
Comment: This is enforced as a rolling 30-day period.  
Recommendation: If the intention is rolling 30-day period than mentions of “per month” should  
be changed to “per rolling 30-day period.”  
R 420.27(19), R 420.207(14), R 420.804(1), R 420.15(1) [Criminal Activity Reporting,  
consistency]  
-agency, state police, or local law enforcement (R 420.27(19) - delivery)  
-agency, state police, or local law enforcement (R 420.207(14) - delivery)  
-agency and local law enforcement authorities (R 420.804 (1) - at business)  
-agency and local law enforcement authorities (R 420.15 (1) - at the marihuana  
business)  
Comment: Consistency will make for better compliance.  
Recommendation: Make criminal reporting more clear across these 4 rules. No real preference  
just want consistency so we know exactly what to do when there’s criminal activity no matter if  
related to delivery or at the facility.  
R 420.205(2)(d)(i) [Fees]  
(2) To operate equivalent licenses at the same location, all of the following requirements  
must be met:  
(d) The person operating the equivalent licenses at the same location under this rule shall do  
all the following:  
(i) Apply for and be granted a separate state license and a state operating license and pay  
the required fees for each license.  
Comment: medical license fees should be reduced for holders of equivalent licenses.  
Recommendation:  
Other:  
-Aside from CPA attestation, not requiring any more SA information for Persons who are  
prequalified and applying for new entity.  
-making renewal date a single date in the year (e.g. Liquor May 31). Any information that would  
otherwise be required of the SA when applying for a new application, will be provided at time of  
renewal.  
February 17, 2020  
Marijuana Regulatory Agency  
Legal Section  
P.O. Box 30205  
Lansing, MI 48909  
Re: Comments on the Proposed Combined Topic-Based Rule Sets  
To Whom it May Concern:  
R 420.201 (a) defines “active ingredient” as marihuana, as defined in section 7106 of the public  
health code, 1978 PA 368, MCL 333.7106.”  
The proposed definition of “active ingredient” excludes industrial hemp. If this definition is  
adopted, we will find ourselves in a situation where the same chemical compoundsfrom the  
same genus and species of plantare considered either “active ingredients” or “inactive  
ingredients” depending on the percentage of THC in the plant.  
For example, CBD from a Cannabis Sativa L plant with more than .3% THC would be  
considered “active ingredient”. This CBD could be added to products under the proposed  
definition. On the other hand, Chemically identical CBD from a Cannabis Sativa L plant with  
less than .3% THC would be considered “inactive ingredient”. This CBD could not be added to  
products under the proposed definition because “inactive ingredients” must be approved by the  
FDA under 420.206 (11).  
As a second example, a terpene from a Cannabis Sativa L plant with more than .3% THC would  
be considered “active ingredient”. This terpene could be added to products under the proposed  
definition. On the other hand, a chemically identical terpene from a Cannabis Sativa L plant  
with less than .3% THC would be considered “inactive ingredient”. This terpene could not be  
added to products because inactive ingredients must be approved by the FDA under 420.206  
(11).  
Dual treatment of the same ingredient from the same genus and species of plant would be  
confusing and misleading to patients and customers. The cannabinoids and terpenes in  
marijuana products have the same medicinal properties regardless of the THC content in the  
Cannabis Sativa L plant from which they were extracted. The common usage definition of  
“active ingredient” carries the connotation of medicinal effect. A product label that listed a  
biologically active ingredient as an “inactive ingredient” would be misleading.  
1
This is important because listing “inactive ingredients” is a labeling requirement in 420.206 (11).  
“All non-marihuana inactive ingredients must be clearly listed on the product label.” Listing the  
same cannabinoid or terpene ingredient as an “active ingredient” on one package and an  
“inactive ingredient” on another package would confuse customers, and it has the potential to  
cause customers to take the wrong dose of the ingredients they are seeking. It’s easy to  
imagine a patient or customer taking too large a dose or serving of a marijuana product because  
he or she was over-compensating for an ingredient that was listed on the product label as  
“inactive”.  
We ask that MRA solve the problems described above by updating the definition of “active  
ingredient” to include industrial hemp.  
2
R420.305 (1) (h) defines “final package” as “the form a marihuana product is in when it is  
available for sale by a marihuana sales location.”  
It appears this definition of final package is attempting to conflate two independent and  
important concepts, “final package” and “final form”.  
We believe “final form” should be defined in the rules in addition to “final package”.  
“Final form” should be defined as the “final set of ingredients, after all processing, mixing,  
curing, filling, quality control, and other preparatory processes have been completed, such that  
the product is in the same state it will be in when sold by a retailer”.  
“Final package” should be defined as “the final retail-ready protective packaging that houses  
and protects a product that is in final form, so it can be sold by a retailer”.  
We worry that conflating the concepts of “final package” and “final form” could lead us to a  
situation in which processors are not allowed to produce marijuana-infused products in a way  
that allows for remediation and/or retesting because any product produced would be considered  
a product in “final package” as soon as it was in “final form”.  
We hope to be able to produce an item and have it tested in “final form” before we place it into a  
“final package”. We hope to have the opportunity to remediate an item like a cartridge or edible  
after a failed test, before it is placed into retail-ready packaging. Remediation is technically  
possible and completely safe in situations like a potency fail in an edible or a residual solvent fail  
in a cartridge. We ask that remediation and retesting be allowed in all situations where full  
compliance testing can be performed after remediation, to ensure patient safety is in no way put  
at risk.  
R. 420.303 (10) says, “After a package is created by a producer of the marihuana product in its  
final package, the producer shall have the sample tested pursuant to R 420.304 and R  
420.305.  
We believe this rule should be changed to say, “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.  
This change requires the addition of a definition of “final form”, which we believe will remove the  
ambiguity from the definition of “final package”.  
3
R. 420.304 (h) says, “a marihuana business that receives a certificate of analysis stating that  
the sample meets specifications required by the agency shall ensure that the test results  
entered into the statewide monitoring system matches the information provided on the certificate  
of analysis received from the laboratory prior to transportation, sale, or transfer of the marihuana  
product.”  
We believe safety compliance facilities should be responsible for uploading accurate data to the  
statewide monitoring system. We are unclear why the responsibility of uploading accurate test  
data to the statewide monitoring system should extend to a grower, processor, or retailer. If an  
audit step or additional redundancy is needed because a laboratory doesn’t have an automated,  
error-free way of uploading results from their internal system to Metrc, this redundancy should  
be provided by a second laboratory employee doing an audit of the certificate of analysis to  
make sure accurate results have been uploaded to Metrc.  
Growers and processors should not be responsible for laboratory mistakes. The statewide  
monitoring system provides test results in a standardized format. On the other hand, each  
certificate of analysis is formatted differently, and it’s often difficult to tell whether a product  
passed or failed testing when looking at a certificate of analysis.  
The statewide monitoring system should continue to be the system of record for test results.  
Growers, processors, and retailers should be able to rely on the test results in Metrc. Growers,  
processors, and retailers should not have to check a COA to verify the data in Metrc is accurate.  
4
R420.305 (10) says, “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 LOQ is a  
failed sample.”  
We understand and support the requirement in the MMFLA that marijuana be reasonably free  
of chemical residues. MMFLA Sec. 505. (4) says: “A safety compliance facility shall… ...Perform  
tests to certify that marihuana is reasonably free of chemical residues such as fungicides and  
insecticides.”  
The concern we have is that the proposed rule goes beyond the “reasonably free” standard.  
Under the proposed rule, a marijuana product must be absolutely free of chemical residues in  
order to pass testing. Any amount of chemical residue detected would result in a fail, andif  
remediation and retesting are not allowedan order from MRA to destroy the material.  
Modern laboratory equipment is so sensitive that it can pick up contamination into the  
single-digit parts per billion. There must be some level at which a product can be considered  
reasonably free of the chemical residue.  
Extremely low levels of chemical residue in test results indicate contamination in the  
environment or in the equipment, rather than use of a banned pesticide.  
Growers are vulnerable to environmental contamination from neighboring farms. Processors  
are vulnerable to low levels of contamination when they process material on equipment that has  
previously been used to process caregiver material or industrial hemp.  
In cases of low-level environmental or equipment contamination where the licensee has not  
used a banned pesticide, we believe MRA should allow material that fails testing for chemical  
residue to be remediated or used in edibles (assuming the level of chemical residue is below the  
EPA’s Maximum Residue Limit for food).  
We have an additional concern that MRA’s suggested approach of setting “Limits of  
Quantitation”, rather than action limits, incentivises laboratories to use older testing equipment  
so as not to detect contamination below the LOQs set by MRA.  
This approach is akin to closing our eyes and hoping the problem isn’t there. It’s not the right  
approach. Growers, processors, and regulators need more datanot less datain the event of  
low-level environmental contamination, so the problem can be understood and corrected.  
Instead of reporting a result as “not detected” (below the LOQ), laboratories should be  
incentivised to calibrate their equipment as accurately as possible and report the actual result  
detected. Accurate residue data is crucial to the grower, the processor, and the regulator. All  
three parties are aligned in their goal of eliminating the source of the contamination and  
removing the residue contamination from the material.  
5
We feel strongly that the LOQ approach is the wrong path forward for Michigan and the  
Cannabis Industry. This standard goes far beyond the statutory requirement that marijuana be  
reasonably free of chemical residue. And, it creates a situation where growers and processors  
can have massive financial losses due to 1 or 2 parts per billion of chemical residue.  
We ask that MRA use an approach more similar to the EPA’s approach in setting Maximum  
Residue Limits for food, and/or the FDA’s approach in setting Maximum Residue Limits for  
tobacco products.  
6
R. 420.307 (1) defines “research and development testing” as “optional testing performed before  
final compliance testing.”  
Expanding the definition to allow for R&D testing before or after final compliance testing would  
provide valuable data to growers, processors, and regulators.  
When material fails a final compliance test, the grower or processor has no way to know  
whether the failed result was accurate or due to laboratory error. Having an R&D test  
performed after the failed compliance test would allow the grower or processor to gather  
additional data. If the R&D test result conflicted with the final compliance test, the grower or  
processor would then have data to provide MRA when asking MRA to investigate the accuracy  
of the final compliance result.  
Accurate results and clean, safe products are in everyone’s interest. We see no downside to  
allowing R&D testing after final compliance testing.  
If MRA is concerned growers or processors may use R&D testing for “lab shopping”, we would  
point out that lab shopping would more likely occur prior to final compliance testing.  
Additionally, we’d point out that R&D testing after final compliance testing would give MRA  
access to valuable data about disparities between safety compliance facilities. To the extent  
there are disparities in results issued by different laboratories, MRA would surely want to identify  
and fix these issues as quickly as possible.  
R&D testing after final compliance testing is an important tool for growers and processors to  
help MRA identify false positives and other laboratory errors.  
7
R. 420.306 (3) A marihuana product is prohibited from being retested if a final test for chemical  
residue failed pursuant to these rules. If the amount of chemical residue found is not permissible  
by the agency, the marihuana product is ineligible for retesting and remediation, and the product  
must be destroyed. This subrule does not apply to marihuana product that has been obtained  
under a Resolution on Marijuana Product Access for Patients adopted by the medical  
marihuana licensing board.  
This rule is problematic for several reasons:  
1. In the past 12 months we’ve learned that safety compliance facilities do make errors from  
time-to-time. The Choice Labs Processor Facility has had at least three false positives where  
material failed testing for chemical residue, and that failed result was later updated in Metrc  
when the lab acknowledged their mistake. We had an additional 8 samples where the lab  
admitted mistakes that amplified the result, but was unwilling to correct the results in Metrc  
without permission from MRA, which was not granted.  
This rule is written under the assumption that labs don’t make errors, and that just isn’t the case.  
What is the statutory justification for denying a facility the ability to retest an item that failed  
testing for chemical residue? Are the labs so unreliable that a contaminated item could pass  
two subsequent retests? If yes, that underscores the importance of allowing retests.  
In fact, the labs do make mistakes. Samples are prepared by humans. There is always the  
potential for contamination within the lab equipment, glassware, utensils, or elsewhere in the  
facility. Retesting is the best way to find out whether the lab made an error. Why is retesting  
prohibited? Retesting should be encouraged. Confirmation and reproducibility of data are  
cornerstones of the scientific process.  
2. The rule does not distinguish between growers who intentionally sprayed banned pesticides  
on their plants, and growers or processors who suffered extremely low-level (but detectable)  
environmental contamination.  
Ultra-low levels of chemical residue indicate accidental contamination rather than use of a  
banned pesticide. In the event of accidental contamination, processors should be allowed to  
remediate the material to remove the chemical residue. The rule as written will result in  
needless financial losses for licensees, and needless shortages of material for patients and  
customers.  
Growers are vulnerable to large losses from environmental contamination.  
Processors are vulnerable to chemical residue contamination or accumulation during  
processing, even though the processor never has used a banned pesticide.  
8
Consider a processor who purchases trim from an outdoor grower intending to process the trim  
into THC Distillate. The grower’s crop passes chemical residue testing. The processor takes  
that material, extracts it, and concentrates it into THC Distillate. When the processor sends the  
THC Distillate for testing, he discovers the concentrated material has failed testing. In other  
words, the trim was below the LOQ, but the concentrated material is now above the LOQ.  
Under the proposed rule, the material would be ordered destroyed. No retest would be allowed.  
The parties negatively impacted by the failed test result would not even be able to verify that the  
result was in fact accurate through an R&D test after the final compliance test.  
We urge MRA to differentiate between banned pesticide use and accidental environmental or  
equipment contamination. Licensees that haven’t used banned pesticides should be allowed to  
remediate and/or retest in the event of low-level fails.  
9
R. 420.306 (4) says, “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.”  
We’ve been told by MRA that they’re currently not allowing a processor to transfer failed  
material to another processor for remediation. We cannot see any way in which this policy  
benefits licensees, regulators, or patients. A processor is unlikely to have every piece of  
remediation and processing equipment.  
We believe the rules and remediation protocol should allow a processor to transfer material to  
another processor for remediation. As a processor, we intended to offer remediation services to  
other processors who may not have the equipment we have. We were disappointed not to be  
able to offer this service.  
10  
R 420.404 says, “A marihuana sales location shall not sell or transfer marihuana-infused  
products that exceed the maximum THC concentrations established by the agency. For the  
purposes of maximum THC concentrations for marihuana-infused products, the agency shall  
publish a list of maximum THC concentrations and serving size limits.”  
The maximum THC concentrations and serving size limitsas currently enforced by MRAare  
hard ceilings.  
Given that potency results themselves have a margin of error, we ask that MRA allow for a +/-  
range above the maximum THC concentrations and serving size limits that mirrors the  
acceptable laboratory margin of error.  
One additional suggestion:  
Throughout the past year, we’ve seen potency variations of approximately 10% between labs.  
It is our understanding that there is currently no mechanism in the rules to ensure that two  
different labs would give the same (or nearly same) result.  
We encourage MRA to create a rule or internal process designed to reduce variations in results  
between labs.  
It is our view that growers and processors should be able to have their products sampled by any  
licensed lab and receive the same results within a very tight tolerance.  
Sincerely,  
Maxwell Murphy  
Compliance Department  
Choice Labs, LLC  
11  
MICHIGAN CANNABIS MANUFACTURERS ASSOCIATION  
DUAL RULE COMMENTS  
(Feb. 2020)  
SET #1 LICENSES  
Definition of “Same Location” (R 420.1(1)(ai); R 420.203(2)(a)): The continued inclusion of a  
“partition” as the minimum standard of division for more than one license operating at the same  
location is appreciated. Further direction from the Enforcement Division on the minimum  
requirements of a “partition” would be helpful. Doing so would standardize this issue and avoid  
subjectivity on the part of operators and field inspectors.  
Typo (R 420.4(1)): Seems like the word “either” is a mistake.  
Disclosure of Persons “Controlled” by a Person who Controls the Applicant (R 420.4(2)(iv)(B)):  
Among other things, the MMFLA conditions suitability for licensure upon the “integrity, moral  
character, and reputation” of any person who “[i]s controlled . . . by a person who controls,  
directly or indirectly, the applicant.” MCL 333.27402(3)(a)(ii). The MRTMA does not contain a  
similarly detailed provision, but instead merely entrusts the MRA to “promulgat[e] rules . . . that  
are necessary to implement, administer, and enforce [the MRTMA],” and to “grant[] or deny[]  
each application for licensure . . . .” MCL 333.27957 (1)(a-b). Based upon these provisions,  
proposed Rule 420.4(2)(iv)(B)) requires the disclosure “any other person who . . . [i]s controlled,  
directly or indirectly, by . . . a person who controls, directly or indirectly, the applicant.” This has  
been confusing and cumbersome since the inception of the MMFLA application process. The  
requirement is difficult to understand and, taken to its furthest extreme, creates an endless string  
of attenuated control relationships. Propose doing away with the requirement via legislative  
amendment to the MMFLA and by extension, the Proposed Dual Rules, so as to avoid (i)  
unnecessary expenditure of attention and resources on the part of the MRA, and (ii) unintentional  
non-disclosures by applicants. [REQUIRES STATUTORY AMENDMENT]  
60 Day Inspection Window & Need for Preliminary Plan Approval (R 420.4(13)): It is understood  
that this 60 day window is necessary to comply with the 90 day application review period required  
by the MRTMA. (MCL 333.27959(1)). However, only being able to access MRA field inspectors  
after a Step II application is filed, which itself requires substantial completion of an establishment  
build-out by virtue of this limited timeline, creates great risk for prospective operators. It is  
suggested that MRA develop an interim, consistent process for prospective licensees to get  
preliminary site plan approval before filing a Step II, and before assuming the expense of the  
establishment build-out, to lessen the risk otherwise borne by those prospective operators.  
Adjusting the NOD Correction Window to “Business Days” Excluding Holidays (R 420.5(4-5)):  
While the reasons for this limitation are fully understood, often, correction of NODs will involve  
the input of third-party professionals (architects, CPAs, lawyers, etc.), and depending upon the  
timing of same, weekends and holidays can place unnecessary strain on an application who is  
attempting to comply and address NODs in good faith. It is suggestion that the language of this  
rule should be modified to operate upon “business days,” and to exclude national holidays, thus  
ensuring that applicants do not fall victim to timing circumstances outside of their control.  
Express Cure Right for Renewal NODs (R 420.13): Suggest adding an express NOD cure right for  
renewal applications in line with the above comment re: NOD Correction Window for lead  
applications. This is already being done in practice, but is not expressly set forth in the rules.  
Reporting New Civil Lawsuits (R 420.14(5)): In the MMFLA Rules, a licensee needs to update the  
MRA when it is the subject of a new civil judgment. The Dual Rules have expanded that reporting  
requirement for “new . . . lawsuits” that are civil in nature. This is problematic, as it creates an  
incentive for non-licensed contracting parties to leverage the litigation threat against a licensee  
whether or not the actual claims are meritorious. That new requirement should be removed or  
carved out for non-criminal, non-regulatory actions. Only when a judgment is obtained should  
the matter need to be reported. If a case is settled, the MRA does not need to be informed at all  
– as its just business at that point.  
Delivery Business (R 420.20(1)(e); R 420.27): Suggest removing as the service is not needed in  
light of home delivery allowed by licensed Provisioning Centers and Retailers. Also, maintaining  
delivered sales within the seed-to-sale tracking system seems untenable as it is unclear who is  
obligated to “record[] [confirmed sales] in the statewide monitoring system.” (R 420.27(11)(d)).  
These license types are not allowed to “sell” the products (R 420.27(11)(f), as they are only  
allowed to take “physical,” rather than “legal” custody of the marihuana or money (R 420.27(8)),  
and yet deliveries must be recorded after being made in compliance with applicable regulations  
(R 420.27(11(d)), including verifying age and other delivery requirements (R 420.27(11(e)), and in  
instances when delivery business employees are unable to do so, or in certain other cases, these  
license types must return the products to the marihuana retailer (R 420.27(11(g)). This requires  
a great deal of interaction and follow up with the retailer. Since the delivery business employee  
is not an employee of the retailer, limited access area restrictions and visitor log concerns come  
into play, further complicating the situation for no apparent reason. Given the amount of  
oversight and logistics required (R 420.27(12)), it is unlikely that this license type will be viable for  
small business scales, so it will not further the MRA’s social equity initiatives in any meaningful  
way. As such, it is an added complication without a reason. Alternatively, these licensees should  
be required to obtain local approval to increase the controls placed upon this new license type.  
Set #2 LICENSEES  
Only Female Flowering Plants Count in AU (R 420.102(2)): It is suggested that greater  
consideration be given to this standard before formalization. While it is not immediately  
objectionable on its face, the long-term market implications of the loosened standard, coupled  
with the possibility for abuse by bad actors, should be carefully considered by cultivation and  
operations experts to ensure the immediate apparent benefits of the altered standard are not  
outweighed by longer-term negative implications.  
Sale of Seeds, Seedlings, Tissue culture Authorized and No Secured Transporter Needed. (R  
420.102(3, 9)): A good development in the rules. This entire subject matter was very unclear in  
previous renditions of the medical and AU rules.  
Transfer of Inventory Between Commonly Owned MRTMA Processors (R 420.103(3)): Very  
important and necessary development in the rules. Note, the MMFLA processor rule (R 420.109)  
does not include a similar allowance. Why not? Can it?  
Transfer of Inventory Between Commonly Owned MRTMA Retailers (R 420.104(4)): Also a good  
development. Query: If the amount of product to be transferred is under the limits for home  
delivery carriers, can this sort of a transfer be accomplished without use of a secured transporter,  
similar to the rule to transport to temporary events noted above? As presently written, these  
rules would indicate that the answer is “no.” Note, the MMFLA provisioning center rule (R  
420.111) does not include a similar allowance. Why not? Can it?  
Standards for Heavy Metals are Prohibitively High and Should Established through the Scientific  
Process (R 420.107(3); R 420.206(12)): There have been reports that the maximum levels for  
heavy metals established in October are causing hundreds of pounds of flower to only be usable  
in oils, further contributing to the current shortage. There needs to be a 6 month+ runway for  
licensed cultivators to meet these standards, so that a root cause analysis can be performed on  
operating facilities/establishments to determine the source of these heavy metals (water, soil,  
etc.). Also, established standards should be the product of an evaluation by a science-based panel  
of impartial experts. The delayed implementation of the current testing requirements for copper  
and nickel announced on Feb. 5, 2020, is appreciated, but it will only delay the negative  
repercussions of the present standards, rather than alleviating them.  
Set #3 OPERATIONS  
RFID Cards and Logs for Facilities/Establishments (R 420.203(e); R 420.209(4-5)): This could be a  
mandatory requirement under the referenced rules. Alternatively, if deemed to be cost-  
prohibitive as a mandatory requirement, the MRA should make the installation and operation of  
a facility/establishment-wide RFID Access Card and Log system a mandatory requirement of  
GMP/GACP certification as set forth in later rule sets. Doing so will improve safety and  
recordkeeping functions, among other indirect benefits.  
Access to Licensee Records (R 420.203(2)(f)): Right now, the rule says licensee “records,”  
presumably meaning, records of any sort, must be available to the Agency “upon request,” which  
Enforcement has previously clarified means “immediately upon request” in the context of the  
prior MMFLA Rules. Given that many vertically integrated operators will have a corporate  
headquarters and various access limitations/security protocols on certain sorts of “records,” this  
rule needs to clarify which records must be immediately accessible to the Agency, and/or provide  
a 24 hour request window to ensure operators can always comply with such requests.  
Compliance with Natural Resources and Environmental Protection Act (R 420.203(3)(a)): This is  
an expansion of the prior MMFLA Rule’s obligation, which was limited to compliance in the  
context of “waste disposal.” The implications of this expanded requirement could be substantial,  
and the MRA should give operators a 1 year running start at this, similar to the Dual Rule’s  
requirement that a safety compliance facility be “accredited” within a year of assuming  
operations (R 420.107(2); R 420.305(1)(a)).  
No Distinction of Separation for Equivalent Licenses (R 420.205(5)): This is a great rule, and  
exactly what should be done.  
Structure of Rule 6 in Set #3 (R 420.206): This rule spans nearly three pages, and contains various  
operating requirements, some applicable to all classifications of licenses, and some specific to  
certain licenses. There are no sub-titles in the rule and the placement of various sub-parts appears  
somewhat random. Recommend breaking this into separate rules per facility classification for  
ease of understanding and use.  
Incorporation of Good Agricultural Collection Practices for Cultivators (R 420.206(2); R  
420.212(5); R 420.301(i); R 420.305(4); R 420.602(2)(h)): Current rules incentivize growers to  
obtain GMP certification. This is ideal, but GMP does not, by its nature, operate upon the  
“cultivation” of plant products in a meaningful way. To truly achieve the intended result here –  
standardized, repeatable cultivation practices with consistent, safe results – growers must meet  
Good Agricultural Collection Practices (“GACP”). For instance, the definition of “Good  
manufacturing processes” in Set #4 is limited to “manufacturing processes and facilities,” and  
“manufactured” products. The equivalent “cultivation” standards need to be incorporated into  
these rules. Properly incorporating GACP standards into cultivation operations requirements will  
help the State of Michigan effectively compete in the interstate commerce post-Federal  
decriminalization. Potential particulars include: (i) Inclusion of a GMP/GACP Plan requirement  
that can (ii) serve as a basis for MRA benchmark inspections tied to the license renewal process  
or, perhaps, more frequently. The specific incentives provided for achieving certification include  
no testing and/or increased batch sizes. See above discussion re: “Plant Counts” and below  
discussion re: “Harvest Batches.” In the future, depending on development of the matured  
market, this could be changed to require a cultivator achieve GACP certification within two years  
of initial licensure, and GMP/GACP Plans could become mandatory Step-II submissions.  
General Incorporation of GMP for Manufacturing, Packaging and Food (R 420.206(10)): This is a  
great rule, and was part of the prior MMFLA Rules. The question now is how this standard will be  
enforced? It only matters if it is policed properly.  
Forced Sharing Rule (R 420.206(16)): This rule does not appear to be expressly authorized by the  
MRTMA, and does not efficiently serve its own stated purpose, which itself may turn out to be a  
non-issue as the recreational market assumes its final form. Moreover, regardless of the rule’s  
foundation, necessity or effectiveness, the Forced Sharing Rule as presently drafted is susceptible  
to Constitutional challenge because it does not provide an objective standard of compliance or  
enforcement.  
Home Delivery as it Relates to Consumption Lounges (R 420.207): Certain provisions here,  
specifically subsection 7(c-d, h, l), contemplate use of a motor vehicle for deliveries. However,  
the most ideal situation is one where a Retailer is located directly next to a Consumption Lounge  
so that real-time delivery on foot is possible. While there is nothing in this rule that expressly  
disallows such that scenario, greater clarity on that point, and perhaps a relaxed list of  
requirements for such a process, would be ideal.  
Mandatory Installation of Backup Generator Power System (R 420.209): The MRA should  
consider making the installation and operation of a backup generator/power system a mandatory  
requirement under the rules. Alternatively, if deemed to be cost-prohibitive as a mandatory  
requirement, the MRA should make the installation and operation of a backup generator a  
mandatory requirement of GMP/GACP certification as discussed elsewhere in the rule sets. Doing  
so will improve safety and security and avoid product losses that will impact the market and  
pricing, among other indirect benefits.  
Other Composting/Feedstock Disposal Methods (R 420.211(13)): This is a good rule and allows  
operators to come up with more efficient ways to reuse/repurpose cannabis waste in the future.  
Common Ownership MM to AU Transfers (R 420.214): It is suggested that the inverse of this  
process be permanently allowed in the rules. As the market matures, recreational marijuana and  
marijuana product generation will be the primary focus of cultivators and processors, and  
allowing the transfer of AU products to the MM market, as needed, will ensure ample supply for  
the MM market without requiring those operators to dedicate floor space and resources to MM  
licenses that may be better utilized for AU operations.  
Set #4 SAMPLING AND TESTING  
No Limits on Harvest Batches (R 420.301(j); R 420.304(2)(b)): There no longer appears to be an  
express limitation on the size of a “harvest batch.” Prior MMFLA Rules (R 333.248(2)(b)) and the  
Emergency MRTMA Rules (R 42(2)(b)) were limited to 15 pounds. Now the issue seems to be  
limited to the dictates of the definition of “batch,” meaning “same variety that has been  
processed together and exposed to substantially similar conditions.” (R 420.301(1)(e)). While this  
is an ideal situation for operators from a COGs standpoint, it should be offered as an incentive for  
GMP/GACP certification rather than being the general standard. Doing so will incentivize such  
certification, strike a balance between safety and efficiency, and quell work-flow concerns from  
the Safety Compliance operators.  
Skipping Testing for Plant Material Converted into Live Resin or Concentrate (R 420.303(6)): In  
the Emergency MRTMA Rules (R 41(6)), the ability to skip testing until after the finished product  
was produced was limited to 60 pound batches for live resin. Now, the same can be done for  
“concentrates, with agency approval,” and there are no express weight limits. This seems to be a  
good rule, but would be interested in knowing more about what will be required to receive  
“agency approval.” Note, “concentrate” is not defined in this rule set. “Concentrate” is also not  
defined in the MMFLA, but it is included under the MRTMA definition of “Marihuana” (MCL  
333.27953(e)), and has its own definition there as well (MCL 333.27953(g)). Accordingly, a  
defined term for “concentrate” in this rule set would be useful. The rule also says that the Agency  
may publish “guidelines” in this regard.  
Allowance for Transfer of Remediation Product (R 420.306(4)): Quarantined product must be  
able to be transferred between processors for remediation purposes, as there will be certain  
remediation methods that only some processors will have equipment to perform. As it currently  
stands, this is not considered or enabled under the rules and guidance published to date.  
Set #5 MARIHUANA-INFUSED PRODUCTS AND EDIBLE MARIHUANA PRODUCT  
Reference to “Address” on Infused Product Labels (R 420.403(7)(a): Infused products must be  
labeled with the “address” of the marihuana business that processes or packages the product.  
This notation of an address is not a part of the general labeling requirements for marihuana itself.  
(R 420.504). Given that fact, coupled with the amount of other information that must be included  
on labels and the safety concerns brought about by noting the facility/establishment’s address on  
packaging, it is suggested that this requirement be omitted. If patrons want to find a  
facility/establishment’s address, they can look up the license number on the MRA website.  
Set #6 MARIHUANA SALE OR TRANSFER  
Different Warnings for MM and AU Products (R 420.504(k)): Currently, there are different  
warnings required for MMFLA and MRTMA products. This requires the generation and application  
of different labels for the different products, which will otherwise be identical. Enforcement has  
previously instructed that, under the current rules, operators cannot combined the warnings (“For  
use only by registered qualifying patients or individuals 21 years of age or older”) to streamline  
the labeling process. This should be reconsidered in the Dual Rules.  
Prohibits Health Claims in Marketing (R 420.507(3)): This is a new marketing limitation, which  
runs head first into the concept of “medical marijuana” itself, as embodied by the MMMA and  
MMFLA. In fact, as the MRA is well aware, there is a LARA/Medical Marihuana Review Panel made  
up of experts who are responsible for approving debilitating conditions for which a patient might  
be eligible under the MMMA. Yet, the FDA is not supporting any cannabis-based health claims  
right now, so any such marketing statements will constitute regulatory violations. Further clarity  
on what constitutes a health claim (“wellness,” “holistic,” “calming,” “pain management,” etc.)  
should be provided by the Agency to avoid inconsistent compliance and enforcement efforts.  
What Does it Mean to Advertise a “Marihuana Product?” (R 420.507(4, 6-9)): There have already  
been several instances where the Agency, and an operator, disagreed as to whether or not the  
latter was advertising its brand generally, or advertising a “marijuana product” within the context  
of the limitations on public advertisements. The Agency should provide further guidance here, or  
disputes will continue to arise. Also worthy of note, in both the Emergency MRTMA Rules and  
here, the following prior limitation in the MMFLA Rules has been removed: “A licensee shall not  
advertise a marihuana product where the advertisement is visible to members of the public from  
any street, sidewalk, park, or other public place.” (R 333.276(3)). This change is appreciated as  
that prior restriction was overly restrictive in many respects.  
Trade Samples (R 420.508): This rule is identical to the one in the Emergency MRTMA Rules, but  
for the following provision, which has been deleted: “Except for a licensed designated  
consumption establishment, the samples may not be consumed or used on the premises of a  
licensed marihuana establishment.” (R 53(3)). This is a good rule change.  
Allowance of Internal Product Samples (R 420.501(1)(j); R 420.509): This was not allowed in the  
MMFLA Rules, and seems like a welcomed accommodation for testing new products. Note, the  
“results of internal product sampling” must be documented and kept on hand. Does this mean a  
survey of employees’ impressions of the products? Also, the Trade Samples rule clarifies that  
those samples need to be tested and entered into METRC. This rule does not have similar  
language, so clarification on testing and recordation requirements for Product Samples under this  
rule would be helpful. Also, what is the difference between a Trade Sample and an Internal  
Product Sample for a Sales Location? Provisioning Centers and Retailers do not generate  
products, so they would either be given trade samples by up-stream operators, or purchase  
products and then circulate to their employees as Internal Product Samples before stocking on  
the sales shelf? Seems odd. More clarity should be provided on these issues.  
Product Development Allotment (R 420.510): Per sub-2, up to 50 plants do not count toward the  
operators total plant count, which is great. R&D testing is allowed, as further explained in R  
420.307. Generally, this is a good rule addition. These products to employees for market research,  
and can sell those products to a Sales Location, assuming they passed testing. The rule also allows  
operators to participate in research studies with prior Agency approval which is appreciated.  
Set #7 EMPLOYEES  
Operations Plan Requirement in Employee Training Manual (R 420.602(e)): This is a new  
requirement not previously included in the MMFLA Rules. Must address policies to avoid over-  
intoxication, underage access, illegal sales and other potential criminal activity. The MRA should  
provide an initial 6 month runway to generate these Manuals to ensure they are based in  
operational fact rather than hypothetical speculation.  
21+ for Dual Employees (R 420.602(2)(j): Because equivalent licensed operators have to comply  
with this limitation from the MRTMA, it basically makes it impossible to employ persons between  
the ages of 18 and 21, unless the operator is running a strictly MM facility. This is unfortunate,  
especially with regard to contractors and student interns. But, since the 21+ requirement is a part  
of the MRTMA itself, a statutory changes is required. [REQUIRES STATUTORY AMENDMENT]  
Criminal History for Dual Employees under MMFLA/MRTMA (R 420.602(2)(k)): Since nearly all  
Sales Locations will have “equivalent licenses” for MM and AU, the more restrictive prohibitions  
in the MMFLA (“past 10 years for a controlled substance-related felony,” R 333.27405) will always  
apply, and the social equity initiatives of the MRTMA (disqualifying offenses limited to distribution  
of a controlled substance to a minor, R 56(2)(b)) will be thwarted. Under this bulletin, the Agency  
must provide prior approval if an operator under the MMFLA wishes to hire, or continue to  
employ, a person with a disqualifying offense, so it is possible that the Agency could alleviate the  
conflict between the hiring limitations in this way, but it would be preferable to align the two  
standards via amendment of the most restrictive MMFLA standard. [REQUIRES STATUTORY  
AMENDMENT]  
Set #9 DISCIPLINARY PROCEEDINGS  
Advanced Reporting re: Labor Peace Agreements (R 420.802(3)(h)): Changes to Labor Peace  
Agreements must be reported in advance, which is odd if one assumes that, in most cases,  
changes will come due to unexpected breakdowns in renewal negotiations. This should be  
addressed in the context of the grander discussion on these Labor Peace Agreements generally.  
Reporting New Civil Lawsuits (R 420.802(5)): As mentioned in the comments to Set # 1 regarding  
“Reporting New Civil Lawsuits,” having to report the initiation of any civil case is inadvisable for a  
number of reasons.  
January 8, 2020  
Marijuana Regulatory Agency - Legal Section  
P.O. Box 30205  
Lansing, MI 48909  
Phone: 517-284-8584  
Fax: 517-284-8598  
SENT VIA EMAIL ONLY  
Re: Response to MMFLA and MRTMA Draft Rules and Safety Compliance Facility  
Sampling and Testing Technical Guidance  
Dear Sir or Madam,  
The Michigan Coalition of Independent Cannabis Testing Laboratories (MICIL) – currently  
comprised of all six licensed Safety Compliance Facilities - has reviewed the MRTMA and  
MMFLA draft rules, as the most recently updated Technical Guidance Bulletins.  
Our Coalition has a number of concerns outlined below, as well as suggestions to help amend  
issues that we have identified.  
Thank you in advance for your consideration.  
Benjamin J. Rosman, JD  
CEO & Co-Founder, PSI LABS  
Founder, MICIL  
office: (734) 369-6273  
cell: (248) 703-6463  
MICIL Member Labs  
<Signature Page Follows>  
1
Benjamin J. Rosman – ben@psilabs.org (on behalf of PSI Labs, Ann Arbor)  
Avram Zallen - safety@steadfastlab.com (on behalf of Steadfast Lab, Hazel Park)  
Todd Welch - twelch@viridisgrp.com (on behalf of Viridis Group, Lansing)  
Linda Palmatier - lindap@mispott.com (on behalf of The Spott, Kalamazoo)  
Amy Brown – kolabs@gmail.com (on behalf of ABKO Labs, Warren)  
Michael Goldman - mike.g@IRONlaboratories.com (on behalf of Iron Labs, Walled Lake)  
2
Response to Draft Rules and Technical Bulletin  
R 420.304(2)(b) Unlimited Batch Size:  
“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. 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 draft rules remove the 15 lb. maximum flower batch size, leaving an unlimited  
batch size in its place. It will be extremely difficult for SCFs to obtain a truly  
representative sample if there is an unlimited batch size. Sampling will take longer, be  
more labor intensive, create more of a bottleneck in a system that is already stressed.  
For example, imagine an outdoor grow with a 1,500 lb. total harvest:  
Draft Rules: 1,500 lb. batch  
o
= 7.5 lbs. of 1,500 lb. batch required (0.5% minimum of the batch)  
o
Rule 4(2)(b): "At least 50% of the batch must be homogenized for  
testing":  
§
In the example above, this would mean needing to  
homogenize nearly 4 lbs. of flower for testing.  
Current Rules: 100, 15 lb. batches  
=100, 0.075 lb. samples required  
o
Contamination can often spread out in a heterogeneous manner – especially for  
microbiological contamination. Splitting samples up across 15lb. batches helps samplers  
(and facilities) identify areas of the harvest batch that may be more problematic.  
Recommendation: Michigan should not change the 15 lb. maximum batch size.  
R 420.301(g):”Final Package”  
“‘Final Package’ means the form a marihuana product will be in after fully complying  
with these rules. This is the form marihuana product is in when it goes from a marihuana  
sales location to a consumer, registered qualifying patient, or a registered primary  
caregiver.”  
3
This definition requires more clarity - especially since SCFs can be given citations for  
providing retests of a product that is in its “final package”.  
As an example, it is unclear if the following would be considered final packaging:  
o
o
o
Products in boxes/packaging, but without affixed test result labels.  
Products in packages but without any labels whatsoever.  
Products in packages that have failed, but were taken out of the packages and  
submitted for a retest?  
o
Products in packages, but would be further packaged (e.g., gummies in a bag, but  
will be placed in an additional container) or would be repackaged.  
There is no clear scientific reason to suggest that once a product has reached a final  
package state it cannot be safely repackaged without compromising safety or quality. If a  
processor is able to package a product once safely it seems likely they would be able to  
unpack and repack product as needed.  
Recommendation: the definition of "Final Package" needs an explicit, clarifying  
definition to help alleviate industry confusion.  
R 420.304(2)(e)(iv): "laboratory confirms"  
“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.”  
The state has placed the responsibility on SCFs to monitor their clients, ensuring they are  
in compliance with the rules. In effect - an SCF must act as both a laboratory and a  
branch of MRA-Enforcement. However, in failure of those Enforcement duties, the SCF  
(whose most important duty, and expertise, lies with the testing of samples for  
compliance) faces penalties, including citation or even suspension.  
Should the onus not be on the sample-submitting facility itself? And because MRA  
regulates and monitors all traffic via Metrc, could MRA not take this on as their  
responsibility?  
For example, if a sample has failed for chemical residue, it should automatically be  
placed on hold and not be able to be transferred to another facility.  
Recommendation: MRA should handle all aspects of enforcement, tracking and  
monitoring, rather than relying upon (and penalizing) licensed facilities, who should  
spend their time perfecting their own processes.  
4
R 420.305(1)(a): Scope of Accreditation  
A lab must be accredited within 1 year of licensing. However, there is no mention (and  
has never been mention in any previous rule set) that after 1 year a lab must have each  
specific assay (and analyte) in its scope of accreditation in order to perform that test.  
Recommendation: The state should further clarify this verbiage to allow MRA to  
approve and validate a SCF’s new method, and allow at least 6 months for a scope  
expansion (which should fall within the SCF's regular ISO surveillance period).  
R 420.305(12): COAs to MRA  
Sending COAs of all failing results to MRA is unreasonably burdensome - especially  
when all of the data is available to MRA in Metrc. However, upon request the SCF can  
send any and all COAs. The need to send all failing COAs will slow a SCF's turnaround  
time and, generally, negatively impact industry health.  
Recommendation: MRA should rely upon Metrc-submitted lab data, and request  
COAs on an as-needed basis.  
R 420.304(2)(f): Three Day Rule:  
“The laboratory shall enter into the statewide monitoring system the test results within 3  
business days of test completion.”  
Mandating a testing facility to meet deadlines, imparts undue pressure on the analytical  
staff that will ultimately lead to quality assurance issues within the laboratory. The very  
standard that the MRA requires the Safety Compliance Facilities to meet for accreditation  
purposes (ISO 17025), specifically addresses these pressures that have a negative impact  
on the impartiality of the test results and the laboratory’s quality management system  
governing those results.  
Recommendation: MRA needs to narrowly define “test completion”, given that  
technical and administrative reviews are a standard, necessary practice.  
R 420.305(4): GMP Certification to Replace Aspects of Safety Compliance Testing:  
“All marihuana businesses 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  
5
allowances.”  
The ISO 17065 standard is what certification bodies become accredited to which brings  
higher credibility to their product certification operations. They are not an accrediting  
body and subsequently cannot offer accreditation, rather they certify the quality of a  
product being manufactured. Nowhere in the FDA’s Code of Federal Regulations Title  
21, where Good Manufacturing Practice is addressed, does it suggest allowances can be  
made from regulated testing requirements.  
Good Manufacturing Practice (GMP) is internal to one’s processes and should not  
be used as a measure to avoid testing requirements that ensure the health and safety  
of consumers.  
R 420.306(2): MRA-enforced lab shopping  
"The laboratory that reported the initial failing results shall not perform the tests".  
This is arbitrary and there is no scientific evidence to support the practice. The test should  
be performed the same way each time, if a failed product is remediated and sent for  
retesting, there is no reason why it could not be tested at the same SCF to confirm  
whether the remediation was successful.  
Lab shopping is already a known problem within the cannabis industry. This rule  
mandates that a facility must attempt to find another lab that will pass their product.  
Pursuant to Rule 5 (13), the state already mandates proficiency testing in an attempt to  
ensure standardization across labs. Further, in order to perform the assay, the lab's  
methods must have already been approved by both the state and an ISO 17025  
accreditation body.  
Recommendation: MRA should not promote doubt and a lack of confidence in its  
licensed SCFs. MRA must not force facilities to shop for a lab that will give them the  
most favorable results. Simply put, MRA should not mandate lab shopping.  
Vape Cartridges - required ATA tests, additives and copper test  
ATA Testing:  
o
We want to ensure that moving forward (post-emergency rules), Vitamin E-  
acetate (ATA) will be a required test for all newly manufactured vape cartridges -  
6
not merely something notated on a waiver/attestation form, signed off by  
processors. The recent outbreak of lung injury associated with vape cartridges  
(EVALI) is becoming a serious health crisis.  
o
Recommendation: Michigan must enact a mandatory ATA test for all vape  
cartridges. Anything less would be irresponsible.  
Additives:  
o
o
It is currently unclear if botanical terpenes are allowed as an additive, though they  
are chemically indistinguishable from cannabis-derived terpenes. All vape  
cartridges (and other marihuana products) are tested for pesticides, metals,  
solvents (and hopefully ATA) under MRA.  
Recommendation: MRA should allow processors to use botanical terpenes as  
additives, since they are chemically indistinguishable from cannabis-derived  
terpenes, and they will ultimately undergo the same level of testing scrutiny  
as all other marihuana products.  
Required copper test:  
Copper is now a required test - for vape cartridges only. This was amended, where  
o
copper was first required for all marihuana products. Because copper-based  
fungicide is a safe (approved by MRA) and effective tool in eliminating fungal  
contamination, a vast majority of flowers we've tested are "contaminated" by  
copper at high levels. MRA's indifferent knowledge of the fact that patients and  
adults will be smoking plants "contaminated" with copper - but requiring a health  
and safety copper test, solely for vape carts, is unusual and illogical.  
§
One exception could be if there is scientific data to support the idea that  
inhaling vaporized copper is more harmful than inhaling copper during  
combustion of plant material.  
o
Recommendation: Copper should either be a mandatory test for all inhaled  
products, or be removed entirely as a required test.  
Potency Test  
Reported variance:  
7
o
Scientific measurements are reported as ranges or with the ± sign rather than as  
single values because every measurement has some degree of variance, which  
must be reported  
o
o
o
e.g., a cannabis lab may report the variance at 10% relative - an industry  
standard.  
Statistically speaking, an infused marihuana product reported at 200 mg is  
equivalent to 180 - 220mg.  
The potency action limit for certain infused marihuana products is 200mg. If a  
processor yields a “fail” with a test result of 205mg ± 20.5mg (which is  
statistically equal to 184.5mg), it should not result in a “fail”.  
o
Conflicting information currently exists for this guideline.  
§
There is no mention of variances or error tolerances in a recent bulletin on  
infused product limits, however, a separate webpage for “Rule 34” says  
that all limits have a variance of +/-10%  
Recommendation: MRA should account for a lab's reported variance – possibly  
rewriting the “error” section of the testing guide in ISO terms.  
Homogeneity and Potency Test:  
The Homogeneity Test was recently described to our lab by MRA as an optional test for  
processors, though the technical bulletins read as it being mandatory for the first batch  
and every 6 months thereafter.  
Recommendation: A Homogeneity Test should be mandatory, and MRA  
should clarify same to SCFs and Processors.  
A related issue has to do with the difference between Precision and Accuracy – in this  
case, the difference between the homogeneity of a batch of infused products (precision)  
and the variance from the target dose (i.e., accuracy).  
o
Precision is the variability from unit to unit within the batch which is covered by  
the +/-15% variance allowed in Homogeneity Tests.  
8
§
e.g., if each individual increment tested was within +/-15% of each other  
(e.g., 10 mg, 11 mg., 10.5 mg, 12 mg.) - the product would pass  
homogeneity. If the doses were significantly different (e.g., 10mg, 50mg  
and 100 mg), the product would fail homogeneity.  
o
Accuracy is how close the actual measured potency is to the target dose.  
While it is very important to establish that tested products are homogenous (to ensure the  
end user gets the same expected dose each time, that only addresses the precision of the  
edible dosing. Accuracy is not being addressed with the current iteration of Homogeneity  
Testing, and has thus far been ignored for Potency Testing, possibly as an oversight.  
o
Example: Target dose of 200mg, and actual potency of:  
§
§
201mg - fails Potency Test.  
6 mg - passes Potency Test.  
§
Increments tested w/in +/- 15% of each other – 6 mg, 6.4 mg, 6.1  
mg, 6.3 mg – passes Homogeneity Test.  
Recommendation: MRA should mandate the Homogeneity Test (Precision),  
and also flag products as Potency Test failures if the tested potency is not +/-  
15% of the target dose (Accuracy). Remediation can include repackaging with  
a different label to reflect the lower/higher dose.  
Measuring both Precision and Accuracy is crucial for establishing the  
consistency of the products from package to package and dose to dose, and  
will also help ensure that the dose is within +/- 15% of the target dose (often  
permanently printed on packages as part of branding).  
9
Recommendations on Proposed Marijuana Rule Sets  
Overview  
The current regulation and interpretation of cannabis flower/cannabis concentrate remediation  
is significantly reducing the ability of safe cannabis to get to market, and in turn negatively  
effects patients, industry stakeholders, as well as the framework of the medical and adult-use  
cannabis programs. In addition to these negative impacts, the current rules significantly reduce  
scientific method development and innovation. Furthermore, the decreased product to the  
legal market as a result of these regulations will continue to raise the cost of licensed products  
and prolong the dependency on caregiver cannabis. These industry impingements will continue  
to drive down the cost of black-market cannabis products, forcing patients and adult-use  
consumers to the black/external market for cheaper cannabis products.  
The overall success of the cannabis industry hinges on the success of the patients/consumers,  
licensed operators within the industry, and the MRA. Without the success of these three  
components together, the industry will seize to grow effectively and efficiently. The current  
regulation specific to remediation of cannabis flower/cannabis concentrate stands in the way of  
a successful cannabis industry. The below comments and suggestions provide specific detail to  
how to overcome these roadblocks. Which will in turn provide patients and consumers access  
to significantly more safe cannabis products, allow cannabis businesses to grow and operate  
efficiently, and the MRA/State of Michigan to maintain an efficient cannabis market.  
Marihuana Sampling and Testing  
R. 420.306 Testing marihuana product after failed initial safety testing and remediation.  
Rule 6. (1-4)  
Current verbiage: (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. The laboratory that reported the initial failing results  
shall not perform the tests. If both samples pass, the batch is out of quarantine and eligible for  
sale or transfer. If 1 or both samples fail, the marihuana product must be destroyed as provided  
in these rules or remediated as described in subrule (4) of this rule.  
(3) A marihuana product is prohibited from being retested if a final test for chemical residue  
failed pursuant to these rules. If the amount of chemical residue found is not permissible by the  
agency, the marihuana product is ineligible for retesting and remediation, and the product  
must be destroyed. This subrule does not apply to marihuana product that has been obtained  
under a Resolution on Marijuana Product Access for Patients adopted by the medical  
marihuana licensing board.  
(4) 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.  
Issues with current verbiage: The current regulation and interpretation of cannabis  
flower/cannabis concentrate remediation is significantly reducing the ability of safe cannabis to  
get to market, and in turn negatively effects patients, industry stakeholders, as well as the  
framework of the medical and adult-use cannabis programs. In addition to these negative  
impacts, the current rules significantly reduce scientific method development and innovation.  
Furthermore, the decreased product to the legal market as a result of these regulations will  
continue to raise the cost of licensed products and prolong the dependency on caregiver  
cannabis. These industry impingements will continue to drive down the cost of black-market  
cannabis products, forcing patients and adult-use consumers to the black/external market for  
cheaper cannabis products.  
The overall success of the cannabis industry hinders on the success of the patients/consumers,  
licensed operators within the industry, and the MRA. Without the success of these three  
components together, the industry will seize to grow effectively and efficiently. The current  
regulation specific to remediation of cannabis flower/cannabis concentrate stands in the way of  
a successful cannabis industry. The below comments and suggestions provide specific detail to  
how to overcome these roadblocks. Which will in turn provide patients and consumers access  
to significantly more safe cannabis products, allow cannabis businesses to grow and operate  
efficiently, and the MRA/State of Michigan to maintain an efficient cannabis market.  
Resolution to current verbiage: Based on the concerns described above, we suggest that  
cannabis processors are allowed to perform remediation without limitation for all failed  
cannabis concentrates, including those which have failed for chemical residue, residual  
solvents, metals, and other testing parameters which may define a cannabis product unsafe for  
consumption. Furthermore, we suggest that there should be no reason that a cannabis product  
should be forcefully destroyed as all residual impurities can be removed via scientific method  
and thus render said product safe for consumption. Product should only be destroyed  
voluntarily when the processor/producer decides is necessary per voluntary product  
destruction protocols that are already in place by the state. Failed cannabis product should also  
be able to be transferred from processor to processor for remediation if a processor does not  
have the capability to remediate for a specific toxicity.  
Not allowing unlimited remediation of cannabis product until it is rendered safe for  
consumption significantly hurts the patients/consumers of Michigan, cripple’s industry stake-  
holders and cannabis businesses, and hinders the ability of the MRA to manage a market that  
doesn’t rely on external market product.  
R. 420.305 Testing; laboratory requirements  
Rule 9.  
Current Verbiage: The agency shall publish a list of action limits for 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 passing sample.  
Issues with current verbiage: Nowhere in the verbiage specific to the agency publishing  
required safety tests for marihuana products is there detail of lead time of when these  
regulations will be enforced. Historically, the state has added new testing regulations to the  
existing required tests without notice, immediate enforcement, and has attempted to  
retroactively enforce new regulation on product that has been produced prior to the addition  
of new regulation or has been submitted for testing prior to new compliance regulation. This  
has negatively impacted the industry by forcing product to be destroyed, significant immediate  
changes in infrastructure to accommodate new regulation, and overall restricted product to  
market which in turn negatively impacts the regulated market, the patients, industry  
stakeholders, and further bolsters the external market.  
Resolution to current verbiage: Considering there is no specific time frame established for the  
agency to implement new regulation, we suggest that a period of 9 months be put into place  
prior to any new compliance testing regulation being enforced. This lead time will allow both  
cannabis cultivators and producers enough time to make changes to processing and cultivation  
protocol and infrastructural changes to accommodate new regulation. Considering the lifecycle  
of a cannabis plant at scale, this lead time will allow cultivators to make changes as needed in  
their protocols to be in line with new regulation without negatively impacting the plants at  
various stages of growth or while in testing. Furthermore, this lead time allows for cannabis  
processors to source new equipment, onboard and train new processes that may be required to  
accommodate for new regulation, make changes to internal processes, and protect any product  
which is in process or in testing when new regulation is announced. Additionally, we suggest  
that a scientific review board be established with members of the agency and active industry  
stakeholders/license holders to meet on a monthly basis to review new suggestions to  
compliance testing regulation as to fully understand and communicate the scientific reasoning  
behind any new compliance regulation and the economic impact of such changes.  
Marihuana Sale or Transfer (2019-72-LR)  
R 420.509 Internal Product Samples  
Rule 9. (6)  
Current verbiage: “A producer is limited to providing a total of 5 grams of marihuana  
concentrate of internal product samples to their employees in a 30-day period.”  
Issue with current verbiage: The allotment of a total of 5 grams of concentrate as internal  
product samples for all employees in a 30-day period does not provide for enough available  
concentrate to effectively be sampled based on volume of production in a processing facility. It  
is not uncommon for more than 30 production batches of one type of concentrate product (ie.  
Live resin concentrate) to be submitted to testing in a 30-day period. A maximum of 5 grams in  
a 30-day period for all employees inhibits the ability to effectively perform quality assurance on  
manufactured goods to ensure they meet the standard of the manufacturer prior to going to  
market. Furthermore, it is common for a producer to make multiple types of cannabis  
concentrate products which include but are not limited to shatter, crumble, cured resin, live  
resin, THCA isolate, sauce, vape carts, rosin, dry sift, batter, RSO, and distillate which are all  
commonly packaged in 0.5g-1g units. Considering the significant number of products which can  
be produced in a processing facility, a limit of 5 grams total to all employees as samples in a 30-  
day period does not reflect the actual amount needed to effectively sample the products  
produced to ensure the product meets the standards of the producer. Additionally, the  
employee population of licensed producers varies from location to location as some facilities  
are significantly smaller or larger than one another. A limit of 5 grams for all employees in a 30-  
day period does not account for the difference in employee population from producer to  
producer and thus further restricts the number of samples which can be provided.  
Resolution to current verbiage: Considering the above concerns with the proposed regulation  
that a producer is limited to providing a total of 5 grams of marihuana concentrate to their  
employees in a 30-day period, we suggest that a producer should be allowed to provide 5  
grams of marihuana products to each individual employee in a 30-day period. This will  
effectively allow for employees to sample a representative amount of product produced by a  
facility, as well as account for the difference in employee population between licensed facilities.  
In addition, this will help account for the various number of products produced by a cannabis  
producer to effectively be samples (ie. Vape carts, live resin, cured resin, isolate, crumble,  
shatter, etc.).  
R 420.510 Product Development  
Rule 10 (3,6,9)  
Current Verbiage: (3) A producer may designate up to 5 grams of marihuana concentrate for  
product development in a 30-day period. Any marihuana concentrates designated for product  
development must be tracked in the statewide monitoring system. (6) A licensee authorized  
under this rule to engage in product development may transfer its product development  
inventory to its employees for consumption. A licensee shall have product development  
inventory tested pursuant to R 420.304 and R 420.305 before transfer to its employees. The  
licensee shall not transfer or sell product development inventory to a marihuana sales location  
until after test results in the statewide monitoring system indicate a passed test. Any product  
development inventory that is not properly transferred to an employee must be destroyed  
pursuant to these rules. (9) A licensee authorized under this rule to engage in product  
development may also engage in a research study with a college, university, or hospital  
approved by the United States Food and Drug Administration and sponsored by a non-profit  
organization or researcher within an academic institution researching marihuana. A licensee’s  
participation in a research study must be approved by the agency.  
Issues with current verbiage: The limitation of only being able to designate 5 grams of cannabis  
concentrate in a 30-day period for product development is a major concern. Any limitation on  
cannabis concentrate being designated for product development only inhibits innovation and  
reduces new products to market which in turn constrict the regulated market. Furthermore,  
this restriction on product development does not allow for enough cannabis concentrate to be  
allocated for any type of research study and/or observational trial. Overall, the suggestion of  
restricting product development to only 5 grams of cannabis concentrate per month inhibits  
the scientific endeavor and our ability to understand proper dosage from a clinical perspective.  
Resolution to current verbiage: Considering the above stated issues with the current verbiage,  
we suggest that an unlimited amount of cannabis concentrate be allowed to be allocated for  
product development as deemed necessary by the license holder. This will allow cannabis  
producers to participate in unrestricted innovation to develop new, unique, and more  
safe/accurate methods of consuming cannabis concentrate. Furthermore, we suggest that  
these products assigned to product development in line with a research study/observational  
trial alongside a college, university, or hospital approved by the FDA and sponsored by a non-  
profit organization or researcher within an academic institution research marihuana are to be  
allocated without restriction to the patient population of the study in line with the design of the  
approved study. The unrestricted amount of cannabis concentrates to be used as product  
development will enable a research study to progress in an effective and efficient manner as  
restriction of the drug being investigated will only restrict the study.  
As licensed operators drawing on years of experience both inside and outside the industry, we  
feel strongly that our recommendations will streamline the Michigan cannabis industry’s ability  
to deliver more product to market, ensure all products are safe for consumption and allow  
Michigan’s rules and regulations to be a best practice for other states.  
These suggestions are supported with signature permission by the following industry  
stakeholders.  
Sincerely,  
Ryan Ratzloff  
President/Founder Lion Labs Ltd  
Jonathan Kane  
Chief Scientific Officer Lion Labs Ltd  
Robin Schneider MICIA  
On behalf of MICIA’s members  
Ben Rosman + Lev Spivak-Birndorf  
PSI Labs  
Adam Goldberg  
Evergreen Transport  
James Fisher  
New Standard/Canterra Cannabis  
Gene Simon  
Griffin Transport  
Brad Chenoweth  
BlueSol Biomedical  
Emily and Jay Elms + Team  
Organic Healing Garden  
Alex Ditton  
Green Tree Relief  
;