Viridis-CRA Contested Hearings, May 15 and May 16, 2023.

Viridis v MRA, Vol.
1 HAGARD
5/30/23
·1· · · · · · · · · · ·· STATE OF MICHIGAN
· ··
·2· · · MICHIGAN OFFICE OF ADMINISTRATIVE HEARINGS AND RULES
· ··
·3· ·IN THE MATTERS OF:· · · · · · · · ·Docket Nos.:
· ··
·4· · · · · · · · · · · · · · · · · · ·· 21-029794; 22-017866;
· · · · · · · · · · · · · · · · · · · ·· 22-018127; 22-018128;
·5· · · · · · · · · · · · · · · · · · ·· 22-018129
· ··
·6· ·Viridis Laboratories, LLC,· · · · ·Case Nos.:
· ··
·7· ·and Viridis North,· · · · · · · · ·SC-000009; SC-000014;
· · · · · · · · · · · · · · · · · · · ·· 21-000189; 21-001041;
·8· · · ·· Petitioners,· · · · · · · · ··21-001065; 21-000191;
· · · · · · · · · · · · · · · · · · · ·· 21-001044; 22-001066;
·9· ·v· · · · · · · · · · · · · · · · ··21-000192; 21-001043;
· · · · · · · · · · · · · · · · · · · ·· 21-000193; 21-001045
10· ·Marijuana Regulatory Agency,
· · · · · · · · · · · · · · · · · · · ·· Agency: Marijuana
11· · · ·· Respondent.· · · · · · · · · ·Regulatory Agency
· ··
12· · · · · · · · · · · · · · · · · · ·· Case Type: MMF Public
· · · · · · · · · · · · · · · · · · · ·· Investigative Hearings
13· ·
· · · · · · · · · · · · · · · · · · · ·· Filing Type: Complaint
14· ·_____________________________/· · ·by Licensee
· ··
15· ·
· ··
16· · · · · · · · · · · · · · VOLUME 1
· ··
17· · · REMOTE PROCEEDINGS HELD IN THE ABOVE-ENTITLED MATTER
· ··
18· · · BEFORE ADMINISTRATIVE LAW JUDGE STEPHEN B. GOLDSTEIN
· ··
19· ·
· ··
20· · · · · · · · · · · MONDAY, MAY 15, 2023
· ··
21· · · · · · · · · · · · · · 9:04 am
· ··
22· ·
· ··
23· ·
· ··
24· ·
· ··
25· ·REPORTED BY: Suzanne Duda, CSR-3199, RPR, CRR
Page 2
Viridis v MRA, Vol. 1
·1· ·REMOTE APPEARANCES:

· ··
·2· · · ··MR. DAVID R. RUSSELL (P68568)
· · · · ··MR. BRANDON M. H. SCHUMACHER (P82930)
·3· · · ··FOSTER, SWIFT, COLLINS & SMITH, PC
· · · · ··313 South Washington Square
·4· · · ··Lansing, Michigan 48933
· · · · ··(517)371-8150
·5· · · ··drussell@fosterswift.com
· · · · ··bschumacher@fosterswift.com
·6· ·
· · · · · · · ·Appearing on Behalf of Petitioners
·7· ·
· · · · ··MS. RISA HUNT-SCULLY (P58239)
·8· · · ··MS. SARAH E. HUYSER (P70500)
· · · · ··MICHIGAN DEPARTMENT OF ATTORNEY GENERAL
·9· · · ··525 West Ottawa Street
· · · · ··Lansing, Michigan 48933
10· · · ··(517)373-1146
· · · · ··huntscullyr@michigan.gov
11· · · ··huysers2@michigan.gov
· ··
12· · · · · · ·Appearing on Behalf of Respondent
· ··
13· ·
· ··
14· ·ALSO PRESENT:
· ··
15· · · ··Michele Glinn
· · · · ··Adam Layton
16· · · ··Erika Marzorati
· · · · ··Greg Michaud
17· · · ··Lorri Rosier
· ··
18· ·
· ··
19· ·
· ··
20· ·
· ··
21· ·
· ··
22· ·
· ··
23· ·
· ··
24· ·
· ··
25· ·
Suzanne Duda, CSR, RPR, CRR

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·1· · · · · · · · · · ··INDEX OF WITNESSES
·2· ·WITNESS:
·3· ·CLAIRE PATTERSON· · · · · · · · · · · · · · · · · ·PAGE
·4· · · ··Direct Examination by Ms. Huyser· · · · · · · ··59
·5· · · ··Voir Dire Examination by Mr. Russell· · · · · ··68
·6· · · ··Direct Examnation, Cont., by Ms. Huyser· · · · ·72
·7· ·
·8· · · · · · · · · · ··INDEX OF EXHIBITS
·9· ·CRA EXHIBITS ADMITTED:· · · · · · · · · · · · · · ·PAGE
10· · · ··CRA Exhibit 52· · · · · · · · · · · · · · · · ··67
11· · · ··CRA Exhibit 1· · · · · · · · · · · · · · · · ··118
12· · · ··CRA Exhibit 2· · · · · · · · · · · · · · · · ··134
13· · · ··CRA Exhibit 5· · · · · · · · · · · · · · · · ··141
14· · · ··CRA Exhibit 6· · · · · · · · · · · · · · · · ··145
15· · · ··CRA Exhibit 18· · · · · · · · · · · · · · · · ·151
16· · · ··CRA Exhibit 3· · · · · · · · · · · · · · · · ··172
17· ·
18· ·
19· ·
20· ·
21· ·
22· ·
23· ·
24· ·
25· ·

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·1· · · · · · · · · · · · · · · · ·Monday, May 15, 2023
·2· · · · · · · · · · · · · · · · ·9:04 AM
·3· · · · · · · · · · ··R E C O R D
·4· · · · · · · · ··JUDGE GOLDSTEIN:··We're on the record in
·5· · · ··the matter of Viridis Laboratories, LLC, and
·6· · · ··Viridis North, LLC, versus the Cannabis Regulatory
·7· · · ··Agency, consolidated Docket Numbers 21-029794,
·8· · · ··22-17866, 22-018127, 22-018128, and 22-018129.
·9· · · · · · · · ··Today is May 15th, 2023, the date set for
10· · · ··the contested case hearing in this matter.
11· · · · · · · · ··Let me get some appearances starting with
12· · · ··the Agency, please.
13· · · · · · · · ··MS. HUNT-SCULLY:··Yes.··Good morning,
14· · · ··Your Honor.··Risa Hunt-Scully from the Attorney
15· · · ··General's Office appearing on behalf of the
16· · · ··Cannabis Regulatory Agency.
17· · · · · · · · ··JUDGE GOLDSTEIN:··On behalf of Viridis,
18· · · ··please?
19· · · · · · · · ··MR. RUSSELL:··Good morning, Your Honor.
20· · · ··David Russell on behalf of Viridis North and
21· · · ··Viridis Laboratories.
22· · · · · · · · ··MR. SCHUMACHER:··Good morning, Your
23· · · ··Honor.··Brandon Schumacher appearing on behalf of
24· · · ··Viridis Laboratories, LLC, and Viridis North, LLC.
25· · · · · · · · ··MS. HUYSER:··And, Your Honor, this is

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·1· · · ··Sarah Huyser.··I'm also appearing on behalf of the
·2· · · ··Cannabis Regulatory Agency.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··And I see an Erika
·4· · · ··Marzorati, AG.··Is she representing or just
·5· · · ··observing?
·6· · · · · · · · ··MS. MARZORATI:··Your Honor, this is Erika
·7· · · ··Marzorati.··I'm with Sarah Huyser and
·8· · · ··Ms. Hunt-Scully's office, and I'm just observing
·9· · · ··today from our office.
10· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··I see your name
11· · · ··there.··Thank you.
12· · · · · · · · ··MS. MARZORATI:··Thank you, Your Honor.
13· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Last week
14· · · ··the Tribunal received several motions from Viridis.
15· · · ··Let me just look here.··Looks like the first of the
16· · · ··motions was a motion to -- for leave to file an
17· · · ··amended witness list to take deposition of a
18· · · ··previously disclosed witness.··Maybe I'm getting my
19· · · ··dates wrong here for filing, but an authorized
20· · · ··recalling of CRA witnesses, and then there was a
21· · · ··partial motion for summary disposition filed it
22· · · ··looks like May 9th.··Pardon me while I look through
23· · · ··these.··And then there was a motion for -- to
24· · · ··require CRA to file complete documents and require
25· · · ··documents to be introduced, that the documents that

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·1· · · ··to be introduced into evidence be complete or, in
·2· · · ··the alternative, to exclude incomplete evidence.
·3· · · · · · · · ··As an initial matter the partial
·4· · · ··motion -- motion for partial summary disposition as
·5· · · ··untimely.··It will not be considered and is
·6· · · ··stricken.··The dispositive motion at a minimum
·7· · · ··should have been filed at least 28 days prior to
·8· · · ··today's hearing.··But I have reviewed the motion,
·9· · · ··Counsel, substantively, and, quite honestly, you
10· · · ··argue many facts in there that are disputed.
11· · · · · · · · ··So if you wish to include the Court of
12· · · ··Claims opinion as your proofs and ultimately in the
13· · · ··end here that's fine, but the motion itself is
14· · · ··untimely and will not be considered.··It will be
15· · · ··stricken from the record.
16· · · · · · · · ··Petitioner's motion to amend the witness
17· · · ··list, I reviewed that.··That was also not
18· · · ··technically timely filed, but since you did raise
19· · · ··the issue of Ms. Barrett perhaps being a material
20· · · ··witness in your case against the agency I did sign
21· · · ··a subpoena for her attendance at the hearing today
22· · · ··or in subsequent hearing days.··I don't know if
23· · · ··she's a former CRA employee or not, but I seem to
24· · · ··recall Ms. Hunt-Scully may have mentioned that in
25· · · ··your response, she's a former --

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·1· · · · · · · · ··MS. HUNT-SCULLY:··Correct.··Yes.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··-- employee?··Okay.
·3· · · · · · · · ··The motion for complete documents, I'm
·4· · · ··not certain what it is you contend is incomplete,
·5· · · ··so -- it's really not timely filed.··I'm not
·6· · · ··certain what it is you're looking for, Counsel,
·7· · · ··but, you know, just to give you the opportunity to
·8· · · ··make your record in this case I'll allow you to
·9· · · ··argue that motion.··So you can do so at this time
10· · · ··if you'd like.
11· · · · · · · · ··MR. RUSSELL:··Yeah.··Thank you,
12· · · ··Your Honor.··And since we filed that motion I
13· · · ··believe that the -- the CRA has since provided us
14· · · ··with full documents.··So I think that issue is
15· · · ··actually resolved at this time.··We were just
16· · · ··simply asking that the investigative reports that
17· · · ··were only partial in the exhibit list that they
18· · · ··introduce the entire document, and they have since
19· · · ··provided and it's my understanding that they plan
20· · · ··to introduce full exhibits.
21· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··And the Tribunal
22· · · ··did receive everybody's proposed exhibits.
23· · · · · · · · ··So were there any changes made to those
24· · · ··exhibits that you know of?
25· · · · · · · · ··MS. HUNT-SCULLY:··(Moves head from side

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·1· · · ··to side)
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··If that happens
·3· · · ··during the hearing that's fine, just make sure that
·4· · · ··they're submitted sometime after the hearing so
·5· · · ··they can be made part of the record.
·6· · · · · · · · ··I did look through a lot of the exhibits,
·7· · · ··the proposed exhibits, that came in already, so I
·8· · · ··see a lot of emails, I'm not certain.··If you're
·9· · · ··saying, Counsel, that issue is resolved, then fine.
10· · · · · · · · ··Are there any other preliminary matters
11· · · ··before we get started today from the Agency?
12· · · · · · · · ··MS. HUNT-SCULLY:··No, Your Honor.
13· · · · · · · · ··JUDGE GOLDSTEIN:··From Viridis?
14· · · · · · · · ··MR. RUSSELL:··Yeah.··Your Honor, I think
15· · · ··the only issue that's still outstanding, we did
16· · · ··depose Ms. Barrett, who is a former CRA employee on
17· · · ··Friday, and you did, your office did issue a
18· · · ··subpoena for her.
19· · · · · · · · ··As part of our motion we've asked for
20· · · ··complaints from the CRA, specifically that she
21· · · ··testified to that we were never provided with that
22· · · ··relate to complaints against Dr. Allyson Chirio
23· · · ··that we think are relevant to this matter.··I sent
24· · · ··an email on Friday after the deposition.··As soon
25· · · ··as we learned about Ms. Barrett we sent a subpoena

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·1· · · ··in the federal case that we have against the four
·2· · · ··individual defendants, and within the 14 days,
·3· · · ··which was Friday, she was deposed, and so we now
·4· · · ··have that testimony.··We've asked for an expedited
·5· · · ··transcript of that.··I'm told I'll have that by 10
·6· · · ··AM this morning.
·7· · · · · · · · ··As part of that deposition testimony
·8· · · ··Ms. Barrett testified to one at least extremely
·9· · · ··relevant complaint that was filed related to
10· · · ··Dr. Chirio who you will see through testimony is
11· · · ··key to this case.··We've requested that complaint
12· · · ··along with other complaints from field agents that
13· · · ··she testified to about Dr. Allyson Chirio.
14· · · · · · · · ··Ms. Barrett's testimony is highly
15· · · ··relevant.··She worked under Dr. Chirio.··She
16· · · ··testified that Dr. Chirio had asked her to put
17· · · ··facts into investigative reports that were things
18· · · ··that she wasn't aware of that actually happened.
19· · · ··She testified that she manipulated reports.
20· · · · · · · · ··And so this testimony is highly relevant,
21· · · ··and so we appreciate the subpoena being issued, but
22· · · ··we think in addition to that these complaints
23· · · ··should be provided, and there's no -- there should
24· · · ··be no reason why we wouldn't have those as part of
25· · · ··this proceeding.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··What complaint are you
·2· · · ··talking about?··Complaints that other employees
·3· · · ··made against Ms. Chirio?
·4· · · · · · · · ··MR. RUSSELL:··Well, I'll give you an
·5· · · ··example, Your Honor.
·6· · · · · · · · ··One of the things that she testified to
·7· · · ··was Kavita Kale was the supervisor for Dr. Chirio I
·8· · · ··believe at sometime in 2020.··She took Dr. Chirio
·9· · · ··off investigating or off having Viridis North or
10· · · ··Viridis Laboratories under her watch because of her
11· · · ··behavioral issues.
12· · · · · · · · ··After Kavita Kale removed Dr. Chirio from
13· · · ··the oversight of the Viridis Labs Dr. Chirio
14· · · ··apparently sent an email around the CRA alleging
15· · · ··that Ms. Kavita Kale, the CRA employee, was having
16· · · ··an inappropriate relationship with Viridis
17· · · ··employees.··We know that based on that email and
18· · · ··the inappropriateness of that an HR complaint was
19· · · ··made about Dr. Chirio and that email that went
20· · · ··around and we think that's highly relevant.··If
21· · · ··there's an email that was sent internally we'd like
22· · · ··to see that email.··We'd like to see the complaint
23· · · ··that I believe was filed by Julie Kluytman against
24· · · ··her because after that point when Claire Patterson
25· · · ··was put into that position that Kavita Kale once

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·1· · · ··held she put Dr. Chirio back in charge of
·2· · · ··overseeing and investigating the Viridis
·3· · · ··Laboratories.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, response?
·5· · · · · · · · ··MS. HUNT-SCULLY:··Yes.··Thank you, Your
·6· · · ··Honor.
·7· · · · · · · · ··And, you know, these are Counsel's
·8· · · ··representations of what, you know, the purported
·9· · · ··testimony was on Friday.··And I'm not saying that
10· · · ··he's misrepresenting it, I'm just saying that, you
11· · · ··know, please take that into consideration.··But as
12· · · ··we pointed out in our responses to their motion to
13· · · ··be able to amend its witness list to add LeeAnn
14· · · ··Barrett and/or obtain any -- or and obtain any
15· · · ··complaints that were made against Dr. Chirio it's
16· · · ··very last minute.··These things had been pending
17· · · ··for, you know, what, at least a year and a half.
18· · · · · · · · ··And as the -- this Tribunal is aware from
19· · · ··our pleadings Ms.LeeAnn Barrett is a former CRA
20· · · ··employee and she -- it's not been alleged and I do
21· · · ··not believe that she testified at her deposition on
22· · · ··Friday that she had any role in any of the CRA's
23· · · ··investigations into whether Viridis like, you know,
24· · · ··violated any administrative rules.··I don't think
25· · · ··that she had any involvement in, either potential

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·1· · · ··involvement in, whether the CRA unnecessarily
·2· · · ··disrupted Viridis's business operations.
·3· · · · · · · · ··So bringing her in at this late moment --
·4· · · ··I mean, it would completely not be relevant.··It
·5· · · ··would prejudice the CRA.··It would not show whether
·6· · · ··it's more probable or less probable that Viridis
·7· · · ··violated any of the administrative rules or whether
·8· · · ··the CRA -- the CRA's investigation procedures
·9· · · ··disrupted Viridis's business operations.
10· · · · · · · · ··And she was deposed in a pending federal
11· · · ··case, there's pending federal litigation.··I'm sure
12· · · ··this Tribunal is aware of that from the pleadings.
13· · · ··And so that's the intermingling of trying to gain
14· · · ··additional information from Ms. Barrett through
15· · · ··those proceedings for this case.··It's not
16· · · ··relevant.
17· · · · · · · · ··She -- it's my understanding and belief
18· · · ··that she testified on Friday that she didn't have
19· · · ··any role into any of the investigations whatsoever
20· · · ··into whether Viridis violated the administrative
21· · · ··rules.
22· · · · · · · · ··And so because of that and because this
23· · · ··was filed so late, last minute, when these, you
24· · · ··know, witness lists were filed half a year ago, it
25· · · ··should not be allowed, and we would -- the CRA

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·1· · · ··would ask that the Tribunal deny this motion.
·2· · · · · · · · ··MR. RUSSELL:··Your Honor, may I respond
·3· · · ··to that?
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Yes.··Go ahead.
·5· · · · · · · · ··MR. RUSSELL:··Your Honor, Viridis just --
·6· · · ··Viridis Laboratories and Viridis North just learned
·7· · · ··of Ms. Barrett and her relationship or her role at
·8· · · ··the CRA based on an investigation that recently
·9· · · ··occurred.··She -- as a result of that investigation
10· · · ··we learned from the licensee of her role, and what
11· · · ··we then learned was her knowledge about
12· · · ··manipulation of documents by Dr. Chirio.
13· · · · · · · · ··Now, part of our case is that documents
14· · · ··were falsified and manipulated in order to target
15· · · ··Viridis.··So that's highly relevant to the case
16· · · ··that we're going to set forward, set forth.
17· · · · · · · · ··Ms. Barrett also testified to potency
18· · · ··audits that the CRA began in November of 2020.
19· · · ··Now, these audits were related to any potency
20· · · ··results that were over 28 percent.··She testified
21· · · ··affirmatively that those audits were targeted at
22· · · ··Viridis.··That's the purpose of those.··Those
23· · · ··audits cost Viridis a lot of money and resources,
24· · · ··and we -- as evidence will show they had no benefit
25· · · ··to the CRA.··They were simply a resource and money

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·1· · · ··takeaway from Viridis, and that's -- that was the
·2· · · ··purpose of those things.
·3· · · · · · · · ··It's remarkable that the CRA is going to
·4· · · ··take the position of an employee that we just
·5· · · ··learned about and as soon as we learned about it we
·6· · · ··sent a subpoena so that we could get her deposition
·7· · · ··which we did on Friday to do it as quick as
·8· · · ··possible so we're not looking to adjourn this
·9· · · ··hearing.··But in 41 minutes I will have her
10· · · ··transcript.··I'm happy to get that to you as soon
11· · · ··as it comes in so you have that in front of you so
12· · · ··you can make a determination.··But we would
13· · · ··certainly be prejudiced if we're not able to have
14· · · ··those complaints.
15· · · · · · · · ··Like the complaint specifically states
16· · · ··that Kavita Kale, who was the scientific manager at
17· · · ··that time, was having an inappropriate relationship
18· · · ··with someone from Viridis.··Sent around to the
19· · · ··entire CRA.··Obviously, that's going to have a
20· · · ··negative effect on the oversight that the CRA has
21· · · ··on Viridis when you have someone like Dr. Chirio
22· · · ··making these kind of -- these kinds of allegations.
23· · · · · · · · ··We also know that other field agents have
24· · · ··made complaints against her.··We should have the
25· · · ··ability to make a determination and look and to see

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·1· · · ··was Claire Patterson included in those
·2· · · ··investigations.··Was Desmond Mitchell included in
·3· · · ··those investigations.··It doesn't make any sense
·4· · · ··why the -- why the Attorney General's Office would
·5· · · ··take the position that we shouldn't have that
·6· · · ··information.··The fact that they never -- they
·7· · · ··never told anyone about -- they never disclosed the
·8· · · ··fact of LeeAnn Barrett's role at any point is more
·9· · · ··problematic.
10· · · · · · · · ··MR. SCHUMACHER:··We have it.
11· · · · · · · · ··MR. RUSSELL:··As a matter of fact, Your
12· · · ··Honor, I guess we now do have her transcript.··I
13· · · ··just received it.
14· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··So I just
15· · · ··want to make sure I'm clear on something.··You're
16· · · ··asking to have LeeAnn Barrett testifying in this
17· · · ··proceeding and to have the complaints.··Any
18· · · ··complaints that may have been filed by CRA
19· · · ··employees, past or present, against Allyson Chirio
20· · · ··regarding --
21· · · · · · · · ··MR. RUSSELL:··Correct.
22· · · · · · · · ··JUDGE GOLDSTEIN:··-- this -- regarding
23· · · ··Viridis or regarding any and all time periods?
24· · · · · · · · ··MR. RUSSELL:··I mean, it's not a long
25· · · ··time period, Your Honor.··It's from 2020 to the

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·1· · · ··present.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.
·3· · · · · · · · ··MR. RUSSELL:··And yes, yes, we're asking
·4· · · ··for all of them because, you know, Ms. Hunt-Scully
·5· · · ··makes the argument, well, it's not directly related
·6· · · ··to Viridis.··Well, if the complaint is that
·7· · · ··Dr. Chirio is manipulating reports, that's
·8· · · ··certainly relevant to what we're talking about
·9· · · ··here, and that's -- we're going to get into that
10· · · ··and to what the CRA uses in justification in these
11· · · ··superseding complaints specifically for microbials
12· · · ··and potency.··So we certainly should have that.
13· · · · · · · · ··And as far as our unnecessary disruption
14· · · ··of business, if you have an LSS that's sending
15· · · ··emails internally about Viridis claiming or
16· · · ··alleging some inappropriate relationship with
17· · · ··someone at the CRA, obviously there's going to
18· · · ··be -- that's going to be part of the disruption
19· · · ··claim that we have the right to see those.··I don't
20· · · ··know why the CRA would want to hide that
21· · · ··information.
22· · · · · · · · ··MS. HUNT-SCULLY:··Your Honor, may I
23· · · ··respond?··I'm sorry.
24· · · · · · · · ··JUDGE GOLDSTEIN:··Yes.··Go ahead.
25· · · · · · · · ··MS. HUNT-SCULLY:··Yes.··Thank you very

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·1· · · ··much.
·2· · · · · · · · ··It's my understanding that Ms. Barrett,
·3· · · ··she left the Agency.··She resigned.··I don't think
·4· · · ··she was -- I think she left with certain feelings
·5· · · ··against the Agency.··But to allow her or anyone who
·6· · · ··has, you know, unhappy or dissatisfied feelings
·7· · · ··towards the Agency, to bring them in to do a smear
·8· · · ··campaign, in essence, is inappropriate.
·9· · · · · · · · ··What we're here in these proceedings is
10· · · ··to -- you know, for the Tribunal to determine
11· · · ··whether the CRA violated administrative rules and
12· · · ··whether the CRA unnecessarily disrupted Viridis's
13· · · ··business operations.
14· · · · · · · · ··Again, discovery ended last fall.
15· · · ··Whether this came to Mr. Russell and
16· · · ··Mr. Schumacher's attention recently is not relevant
17· · · ··because it's so outside the scope of what this
18· · · ··Tribunal is here to decide.··So it's just -- it
19· · · ··should not be allowed.··We should proceed with the
20· · · ··witnesses that we have listed and are prepared to
21· · · ··provide testimony, and just it should not be
22· · · ··allowed.
23· · · · · · · · ··MR. RUSSELL:··Your Honor, just to -- if I
24· · · ··could respond quickly on that.··You've already
25· · · ··allowed the testimony.··You signed the subpoena.

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·1· · · ··What we're asking for are these complaints.
·2· · · · · · · · ··Now, what Ms. Hunt-Scully just said is a
·3· · · ··smear campaign by Ms. Barrett.··Well, the
·4· · · ··complaints that we're talking about aren't filed by
·5· · · ··Ms. Barrett.··In fact, I believe they're filed by
·6· · · ··Julie Kluytman and other field representatives that
·7· · · ··are still working at the CRA, some of which may be
·8· · · ··in the investigative reports that we're going to go
·9· · · ··through during this hearing, Your Honor.
10· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Well, I
11· · · ··understand the relevancy, Mr. Russell and
12· · · ··Mr. Schumacher.··Shoemaker not Shoemocker; is that
13· · · ··correct?
14· · · · · · · · ··MR. SCHUMACHER:··"Maker," yes.
15· · · · · · · · ··JUDGE GOLDSTEIN:··I do believe it's
16· · · ··relevant, but I want to see how the evidence
17· · · ··progresses.··I'm not going to just order all
18· · · ··complaints that have been filed against Ms. Chirio
19· · · ··during her -- even the last three years just to see
20· · · ··if people are dissatisfied with her decisions.
21· · · · · · · · ··Allyson Chirio, she's on the witness
22· · · ··list; correct?
23· · · · · · · · ··MS. HUNT-SCULLY:··Yes.
24· · · · · · · · ··JUDGE GOLDSTEIN:··She will be testifying.
25· · · ··You can ask her questions on cross.··You can

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·1· · · ··cross-examine the daylights out of her about any
·2· · · ··complaint that may be filed against her.··And if
·3· · · ··you think she's lying, then maybe we can
·4· · · ··re-entertain this -- this request.··But at this
·5· · · ··point I'm not ordering that.··Okay?
·6· · · · · · · · ··I'm not preventing you from exploring
·7· · · ··this -- this subject by any means, especially since
·8· · · ··she will be called as a witness.
·9· · · · · · · · ··MR. RUSSELL:··I understand that, Your
10· · · ··Honor.··The problem is how do I cross-examine a
11· · · ··witness on a complaint made against her when I
12· · · ··don't have the complaint.··It just -- it's
13· · · ··prejudicial.
14· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Well, we'll see
15· · · ··what Ms. Barrett says and then we'll see what
16· · · ··Ms. Chirio says and I'll have to weigh the
17· · · ··credibility then.
18· · · · · · · · ··But, you know, if you have evidence that
19· · · ··Ms. Chirio was somehow -- did inappropriate things
20· · · ··with regard to this investigation, okay, I think
21· · · ··that's relevant to the unnecessary disruption
22· · · ··claim.··But evidence that she may have been a wild
23· · · ··card, I don't know.··I have to -- I have to limit
24· · · ··it to a certain extent.··Okay?
25· · · · · · · · ··This type of hearing we're doing here is

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·1· · · ··a first impression.··So it's a consolidated
·2· · · ··complaint, disciplinary case, and a separate cause
·3· · · ··of action for unnecessary disruption against the
·4· · · ··regulating entity.··And we can't let it go too far
·5· · · ··afield.
·6· · · · · · · · ··I'm letting you make your record.··If you
·7· · · ··explore this issue and it becomes apparent to me
·8· · · ··that I need to order a complaint that may have been
·9· · · ··issued against Ms. Chirio in this case related to
10· · · ··these facts then I will do so.··And that goes to
11· · · ··her credibility.
12· · · · · · · · ··So I see what you're getting at here.··I
13· · · ··do.··But at this point I think it's premature.··So
14· · · ··I'm holding in abeyance any ruling, I'm not denying
15· · · ··it entirely.··Okay?
16· · · · · · · · ··MR. RUSSELL:··Thank you, Your Honor.
17· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Any other
18· · · ··matters to discuss before we start?
19· · · · · · · · ··MS. HUNT-SCULLY:··Your Honor, just
20· · · ··procedurally, I think that Mr. Russell and I have
21· · · ··at least an agreement in principle that of course
22· · · ··we know that the CRA is going to be moving forward
23· · · ··with their proofs and their case on the discipline
24· · · ··complaints, and then having the same witness, you
25· · · ··know, defend against the disruption complaint.

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·1· · · · · · · · ··But I think -- well, my intention is and
·2· · · ··I think Mr. Russell agrees is that I will give my
·3· · · ··opening statement as far as the discipline
·4· · · ··complaints.··I think Ms. Russell would then give
·5· · · ··his counter if he chooses to.··Then he will give
·6· · · ··his opening as far as the disruption complaint, and
·7· · · ··then I will give my response to that.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··That's fine.··Go
·9· · · ··right ahead.
10· · · · · · · · ··MS. HUNT-SCULLY:··Are you ready, Your
11· · · ··Honor?
12· · · · · · · · ··JUDGE GOLDSTEIN:··You've mentioned one
13· · · ··other -- one other item.··You mentioned, Counsel,
14· · · ··do you have a court reporter here?
15· · · · · · · · ··MR. RUSSELL:··Yes.
16· · · · · · · · ··JUDGE GOLDSTEIN:··Ms. Duda, now, you
17· · · ··realize that the hearing recording is the official
18· · · ··record.
19· · · · · · · · ··COURT REPORTER:··Certainly.
20· · · · · · · · ··JUDGE GOLDSTEIN:··The digital recording?
21· · · · · · · · ··COURT REPORTER:··Certainly.
22· · · · · · · · ··JUDGE GOLDSTEIN:··You're making this as a
23· · · ··backup, Counsel; is that correct?
24· · · · · · · · ··MR. RUSSELL:··Correct.··Yes.··We want a
25· · · ··transcribed record.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Ms. Hunt-Scully,
·2· · · ··are you okay with that?
·3· · · · · · · · ··MS. HUNT-SCULLY:··That's fine, yes.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··All right.
·5· · · ··So the official record will be what's captured on
·6· · · ··the recording here.··Ms. Duda, welcome.··As long as
·7· · · ··everybody understands that.
·8· · · · · · · · ··All right.··Ms. Hunt-Scully -- everybody
·9· · · ··hearing me okay?
11· · · · · · · · ··MR. RUSSELL:··Yes.
12· · · · · · · · ··JUDGE GOLDSTEIN:··Go right ahead.
13· · · · · · · · ··MS. HUNT-SCULLY:··Thank you very much.
14· · · · · · · · ··So what I'm going to discuss right now
15· · · ··are the -- the formal discipline complaints that
16· · · ··were lodged against Viridis.··So these are four
17· · · ··superseding formal administrative complaints that
18· · · ··the CRA issued against the various licenses,
19· · · ··medical and adult use marijuana safety compliance
20· · · ··facility licenses on Viridis Laboratories, LLC, and
21· · · ··Viridis North, LLC.··Viridis Laboratories is
22· · · ··located in Lansing, Michigan, and has two licenses,
23· · · ··a medical facility license and an adult use
24· · · ··license.··Viridis North, which is a facility
25· · · ··located in Bay City, also has a medical facility

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·1· · · ··license and an adult use license.··There's four
·2· · · ··licenses at issue here, two facilities, each of
·3· · · ··which have adult use and a medical.
·4· · · · · · · · ··I'm sure and anticipate that throughout
·5· · · ··this proceedings we'll be referring to the safety
·6· · · ··compliance facilities as testing labs or labs for
·7· · · ··marijuana products.··And as this Tribunal is aware,
·8· · · ··the CRA is responsible for administering and
·9· · · ··enforcing Michigan's marijuana laws, and safety
10· · · ··compliance facilities or labs are required to
11· · · ··ensure that testing results are accurate and valid
12· · · ··and that tests are conducted under approved
13· · · ··procedures and that product is safe for public
14· · · ··consumption.
15· · · · · · · · ··The administrative rules, administrative
16· · · ··rules that were promulgated under the -- under the
17· · · ··marijuana statutes require that licensed safety
18· · · ··compliance facilities or labs maintain standard
19· · · ··operating procedures, and we're going to hear a lot
20· · · ··about that throughout these proceedings, the
21· · · ··standard operating procedures and we'll probably
22· · · ··usually refer to those as SOPs.··But the labs are
23· · · ··required to maintain those, and those must be
24· · · ··approved by the CRA.··And labs must ensure and the
25· · · ··CRA must regulate that marijuana tests are

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·1· · · ··conducted under approved procedures, CRA-approved
·2· · · ··procedures, and that the testing results are
·3· · · ··accurate and valid.
·4· · · · · · · · ··So these superseding formal complaints
·5· · · ··that were filed in May of last year allege that
·6· · · ··both facilities, all licenses, violated various
·7· · · ··administrative rules in different ways.··The
·8· · · ··complaints essentially allege that Viridis violated
·9· · · ··the rules in the ways that it was conducting its
10· · · ··potency testing, the way that it was testing for
11· · · ··the presence of microbials, and the way that it was
12· · · ··conducting its foreign matter testing.
13· · · · · · · · ··So in regard to the potency testing, and
14· · · ··that's the first topic outlined in the superseding
15· · · ··complaints, in regard to the potency testing the
16· · · ··complaints allege, essentially, that Viridis was
17· · · ··using procedures not contained in its CRA-approved
18· · · ··standard operating procedure by that it was not
19· · · ··validated by an independent third party and that it
20· · · ··wasn't -- they weren't following the actual
21· · · ··procedure that was contained in their SOP.
22· · · · · · · · ··Factually how this all originally came to
23· · · ··the CRA's attention was that in the fall of 2020,
24· · · ··and the Tribunal will hear testimony to support
25· · · ··this, the CRA observed in the state-wide marijuana

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·1· · · ··tracking system that all licensed facilities in the
·2· · · ··state of Michigan are required to use is called or
·3· · · ··referred to as Metrc, M-e-t-r-c, that Viridis was
·4· · · ··consistently reporting high potency level results
·5· · · ··in its samples that it was testing and reporting
·6· · · ··levels higher than what the CRA scientists, three
·7· · · ··of whom of the four hold PhD degrees, that the
·8· · · ··scientists know from science and from their own
·9· · · ··education and professional experience and research
10· · · ··they know that it was unusually high and out of the
11· · · ··norm to be seeing.··And so that came to the CRA's
12· · · ··attention in the fall of 2020.
13· · · · · · · · ··And so the CRA began to ask questions of
14· · · ··Viridis trying to figure out what was going on.
15· · · ··You know, why are we seeing these high results.
16· · · ··And that's completely in the norm of what the CRA
17· · · ··does.··That's what they do.··When they notice
18· · · ··things that seem to be anomalies, they ask a
19· · · ··licensee questions trying to figure out what's
20· · · ··going on.··Was it, like, an error that was entered
21· · · ··in the Metrc system?··Is there something that's
22· · · ··awry with the procedure?··That's what they do and
23· · · ··they're obligated to do and they have to do.
24· · · · · · · · ··What's notable, in fact, with Viridis is
25· · · ··when they were newly licensed, the CRA, they

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·1· · · ··noticed that Viridis was actually consistently
·2· · · ··reporting through Metrc potency results that were
·3· · · ··much lower than what the CRA would expect and was
·4· · · ··seeing from other licensees.··And so CRA asked
·5· · · ··questions then too to figure out why they were
·6· · · ··consistently reporting lower, lower than expected,
·7· · · ··potency levels.··They did that to assist.··To
·8· · · ··educate.··To help.
·9· · · · · · · · ··So it wasn't just a, you know, checking
10· · · ··in when there were higher potency, higher than
11· · · ··expected potency levels reported, they did it when
12· · · ··it was lower early on.
13· · · · · · · · ··So the CRA started asking questions in
14· · · ··November 2020 about the high potency levels.··And
15· · · ··then in December 2020 through a semi-annual
16· · · ··inspection which was conducted remotely because
17· · · ··this was at the height of the COVID pandemic, but
18· · · ··they connected it remotely, you know, via video.
19· · · ··The CRA scientists, they observed Viridis prep and
20· · · ··conduct testing on a marijuana sample for potency,
21· · · ··and what the CRA observed at that time was that
22· · · ··Viridis was prepping the sample outside -- outside
23· · · ··of its approved standard operating procedure.
24· · · · · · · · ··The last time that the CRA had approved
25· · · ··Viridis's potency testing method was in May of

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·1· · · ··2020, and what the CRA observed remotely during
·2· · · ··that semi-annual inspection in December 2020 was
·3· · · ··Viridis prepping a sample to test for potency not
·4· · · ··in compliance with its approved May 2020 standard
·5· · · ··operating procedure.
·6· · · · · · · · ··You know, and just as background
·7· · · ··information, the CRA has a very specific method of
·8· · · ··approving a licensee's proposed SOP for any type of
·9· · · ··method regardless of what kind of license it is.
10· · · ··It's always in writing.··It's on a written
11· · · ··standardized form.··The CRA never approves a
12· · · ··proposed SOP or a material change to an SOP
13· · · ··verbally or by nonaction.··Never.··There's a very
14· · · ··specific form, and Viridis is very familiar with
15· · · ··this process.··They have submitted lots of proposed
16· · · ··SOPs that have been approved -- for other types of
17· · · ··testing methods that the CRA has approved through
18· · · ··this written form.··That's the only way that the
19· · · ··CRA approves SOPs to begin with, and then material
20· · · ··proposals to SOPs that make a material change.
21· · · ··They don't do it through silence.··They don't do it
22· · · ··through verbiage.
23· · · · · · · · ··So that December 2020 remote semi-annual
24· · · ··inspection Viridis was ultimately given a passing
25· · · ··report for that because it -- otherwise --

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·1· · · ··otherwise failing to prep its potency sample in
·2· · · ··compliance with its approved May 2020 SOP.
·3· · · ··Otherwise it was -- it was in compliance or came
·4· · · ··into compliance with the items that the CRA
·5· · · ··inspects for, kind of a checklist thing.··But
·6· · · ··thereafter the CRA opened an investigation into
·7· · · ··Viridis's noncompliance with its potency SOP.
·8· · · · · · · · ··In June of 2021 that was the next
·9· · · ··semi-annual inspection, so the CRA conducted that.
10· · · ··That was in person this time.··And during the
11· · · ··semi-annual inspection they asked them to in person
12· · · ··demonstrate the potency testing method.··And again
13· · · ··at that time the CRA observed that Viridis was
14· · · ··conducting the potency testing not in compliance
15· · · ··with its CRA-approved SOP.
16· · · · · · · · ··And thereafter the labs, they were
17· · · ··provided with a passing semi-annual inspection
18· · · ··report because they were otherwise in compliance
19· · · ··with the items on that checklist, but they were
20· · · ··asked to submit a copy of the current SOP that it
21· · · ··was using for its potency testing.··They did that,
22· · · ··the CRA reviewed that and denied it in writing
23· · · ··explicitly.··That revised SOP that Viridis
24· · · ··submitted in June 2021 wasn't accompanied by the
25· · · ··necessary data or the information or validation

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·1· · · ··reports that would allow the CRA to approve it.··It
·2· · · ··was explicitly denied.
·3· · · · · · · · ··Despite receiving that explicit written
·4· · · ··denial viridis continued and continues to use the
·5· · · ··testing method that was not approved by the CRA in
·6· · · ··violation of the administrative rules.··And the
·7· · · ··proofs will prove that.··We intend to call all of
·8· · · ··the CRA scientists, and they're going to provide
·9· · · ··testimony that will explain that.
10· · · · · · · · ··I know a lot of these terms are going to
11· · · ··be new to the Tribunal.··They're going to explain
12· · · ··it.··And I expect that at the conclusion of the
13· · · ··proofs the Tribunal will be able to make a
14· · · ··recommendation that those violations have been
15· · · ··substantiated.
16· · · · · · · · ··In regard to the violations regarding
17· · · ··failing to comply with the foreign matter analysis
18· · · ··SOP, in foreign matter, just to try and say it in
19· · · ··layman's term, it's a physical inspection of
20· · · ··marijuana flower for things like mold, pests,
21· · · ··insects, fungus.··And the scientists will explain
22· · · ··that.
23· · · · · · · · ··But in regard to the foreign matter
24· · · ··analysis failure to comply with the approved SOP,
25· · · ··in the fall of 2021 the CRA received a complaint

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·1· · · ··that Viridis had a pattern of not failing foreign
·2· · · ··matter samples that should have been failed, and so
·3· · · ··it opened an investigation and began looking into
·4· · · ··this.
·5· · · · · · · · ··So in October of 2021 the CRA conducted
·6· · · ··on-site audits at each location and also obtained
·7· · · ··surveillance footage for a two-week period from
·8· · · ··September 2021 to -- of the foreign matter analysis
·9· · · ··to, you know, try to figure out what was going on.
10· · · ··And from those audits and from the surveillance
11· · · ··footage the CRA scientists, they observed that
12· · · ··Viridis staff, they had conducted foreign matter
13· · · ··analysis on samples and passed them which were
14· · · ··clearly -- that clearly should have been failed.
15· · · ··And, again, there is a visual inspection.··And by
16· · · ··doing so they're operating outside their approved
17· · · ··standard operating procedures which is a violation
18· · · ··of the administrative rules.
19· · · · · · · · ··Just -- for example, just one of the
20· · · ··things that was observed is that the approved SOP,
21· · · ··or standard operating procedures, for foreign
22· · · ··matter analysis for Viridis provides that Viridis
23· · · ··staff should visually inspect a sample for foreign
24· · · ··matter, look at a marijuana flower for several
25· · · ··minutes, yet there were instances where, either in

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·1· · · ··person or through footage, it was observed that
·2· · · ··Viridis staff visually inspected the sample for
·3· · · ··just a few seconds.
·4· · · · · · · · ··Another example is that the CRA
·5· · · ··scientists, they observed one particular sample
·6· · · ··while they were there in person to basically be
·7· · · ··covered in very visible mold.··And there will be a
·8· · · ··photograph to show this Tribunal that.··Very
·9· · · ··visible even to a layperson.··Yet Viridis staff,
10· · · ··including the lab director -- and this was brought
11· · · ··to the lab director's attention -- said no, this
12· · · ··should be passed through.··It's fine.··And it was
13· · · ··clearly even -- to the scientist, even to laypeople
14· · · ··this marijuana flower was covered in mold.
15· · · · · · · · ··And those are just a couple examples of
16· · · ··how Viridis is alleged to have conducted their
17· · · ··foreign matter analysis outside of a CRA-approved
18· · · ··SOP.··We expect and we intend to provide more
19· · · ··examples through our witness testimony.
20· · · · · · · · ··And then as far as failing to operate
21· · · ··within its approved testing methods for microbials
22· · · ··which, again, is in noncompliance with the
23· · · ··administrative rules in violation of the
24· · · ··administrative rules, in the fall -- again, in the
25· · · ··fall of 2021 the CRA received a complaint that

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·1· · · ··Viridis was passing marijuana product, giving it
·2· · · ··passing results, when it should have failed for the
·3· · · ··presence of microbials.··And microbials, I mean,
·4· · · ··you'll hear testimony that microbials really do
·5· · · ··present or can present a risk to the public as far
·6· · · ··as consumption in various ways.··So they received
·7· · · ··that complaint.··They opened an investigation.
·8· · · · · · · · ··The CRA reviewed information that Viridis
·9· · · ··had passed samples that had been failed by other
10· · · ··labs for the -- for instance for the detection of
11· · · ··the substance aspergillus.··And those samples had
12· · · ··not been remediated by the marijuana grower.··And
13· · · ··I'll explain that.
14· · · · · · · · ··So a grower submits or has samples and is
15· · · ··required to have samples tested for safety by a
16· · · ··safety compliance facility.··By a lab.··If a sample
17· · · ··or product comes back as failing for a certain
18· · · ··substance the grower has the opportunity to what's
19· · · ··called remediate that product.··Take some kind of
20· · · ··action to kill off the fungus or kill off the
21· · · ··bacteria or whatever substance is in the product
22· · · ··that caused it to fail.··Then the grower can have
23· · · ··it retested to see whether it's good to go.··Will
24· · · ··pass or will fail.
25· · · · · · · · ··What the CRA saw happening from the Metrc

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·1· · · ··system and from their investigation is that other
·2· · · ··labs, not Viridis but other labs, would test
·3· · · ··Viridis growers' product for whatever microbial as
·4· · · ··well as other things, and it would fail for that
·5· · · ··microbial.··And very particularly of concern in
·6· · · ··fall of 2021 was aspergillus.··And then the CRA
·7· · · ··could tell from the Metrc system and from their
·8· · · ··investigation that this -- the product would be
·9· · · ··immediately, like the next day, submitted to the
10· · · ··Viridis Laboratories and would receive a passing
11· · · ··result.··And this was without the product being
12· · · ··remediated.··And of course the CRA is going to try
13· · · ··to figure out what's going on.
14· · · · · · · · ··And so during those October of 2021
15· · · ··on-site audits that I talked about earlier where
16· · · ··the CRA staff observed the Viridis staff doing
17· · · ··foreign matter analysis they asked about what was
18· · · ··happening with microbial testing.··And while on
19· · · ··those on-site October 2021 audits CRA staff
20· · · ··observed Viridis staff not following its
21· · · ··CRA-approved SOP for microbial testing.
22· · · · · · · · ··Very importantly, the CRA learned that
23· · · ··Viridis staff had not -- was not always incubating
24· · · ··samples that were being tested for microbials at
25· · · ··the temperatures prescribed by the incubators'

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·1· · · ··manufacturer.··And Viridis staff was not
·2· · · ··documenting what time they put the samples in an
·3· · · ··incubator and out of the incubator, which is
·4· · · ··another step that's proscribed by the incubators'
·5· · · ··manufacturer and they are obligated to follow.
·6· · · · · · · · ··And so the results that Viridis was
·7· · · ··reporting, there was no way to verify whether they
·8· · · ··were accurate or reliable because there was no
·9· · · ··documentation of whether they are putting the
10· · · ··samples in an incubator and when they were taking
11· · · ··them out.
12· · · · · · · · ··And there were instances where I believe
13· · · ··in the Lansing lab they weren't keeping track of
14· · · ··the temperatures that the incubators were at.··And
15· · · ··in Bay City -- I might be getting these two
16· · · ··facilities fixed up -- but Bay City, Viridis North,
17· · · ··they recorded -- no, it was North that didn't have
18· · · ··the temperature logs.··Lansing had logs but the
19· · · ··logs showed that the samples were being incubated
20· · · ··at temperatures outside of the recommendations from
21· · · ··the manufacturer.··And that's outside the approved
22· · · ··SOPs, the CRA SOP for microbial testing.
23· · · · · · · · ··And so -- and just, you know, very basic
24· · · ··layman's terms, by not being able to know whether a
25· · · ··sample has been incubated for the required amount

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·1· · · ··of time and not being able to verify or determine
·2· · · ··whether a sample has been incubated at the right
·3· · · ··temperature, and, in fact, having evidence that
·4· · · ··sometimes it wasn't being causes the concern, very
·5· · · ··real concern, that whatever is coming out of
·6· · · ··Viridis as far as microbial testing is not reliable
·7· · · ··and not accurate.
·8· · · · · · · · ··And so clearly that's a violation of the
·9· · · ··administrative rules.··And the CRA is obligated to
10· · · ··do everything it can to regulate the marijuana
11· · · ··market and to protect the public's health and
12· · · ··safety.··And by investigating these things and
13· · · ··making these findings, of course that's what it was
14· · · ··doing.
15· · · · · · · · ··And they didn't just zing Viridis with
16· · · ··these discipline complaints, they worked with them
17· · · ··to correct the problems.··And they have continued
18· · · ··to test, you know, up until this day because the
19· · · ··CRA has worked with them cooperatively as much as
20· · · ··they could to educate them.··Bring them into
21· · · ··compliance with the rules.
22· · · · · · · · ··And so -- but as a result, all of those
23· · · ··things, the investigation into the failure to
24· · · ··follow its approved potency SOP, failure to follow
25· · · ··through with the approved foreign matter analysis

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·1· · · ··SOP, the failure to follow its approved microbial
·2· · · ··testing SOP, these superseding formal complaints
·3· · · ··were issued.
·4· · · · · · · · ··And we definitely look forward, we're so
·5· · · ··glad that we're able to move forward today and
·6· · · ··these next coming days to providing the CRA's
·7· · · ··scientific and factual proof that these violations
·8· · · ··have occurred.
·9· · · · · · · · ··There's been a lot of pleadings.··A lot
10· · · ··of motions.··A lot of discovery.··I think there's
11· · · ··been a lot of kind of side issues, smoke and
12· · · ··mirrors, presented that were brought to this
13· · · ··Tribunal's attention before now.··So the CRA is so
14· · · ··glad to be able to just put on their witnesses,
15· · · ··demonstrate by a preponderance of the evidence to
16· · · ··this Tribunal that yes, these things happened.
17· · · ··Let's take care of them.
18· · · · · · · · ··And I expect at the conclusion of the
19· · · ··hearing we'll be asking this Tribunal to make a
20· · · ··recommendation that Viridis Laboratories and
21· · · ··Viridis North in all of their four licenses, in
22· · · ··their four licenses they violated the
23· · · ··administrative rules.
24· · · · · · · · ··Thank you very much.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you, Counsel.

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·1· · · · · · · · ··Mr. Russell or Mr. Schumacher?
·2· · · · · · · · ··MR. RUSSELL:··Yes.··Thank you, Your
·3· · · ··Honor.
·4· · · · · · · · ··What the facts are going to show through
·5· · · ··the testimony in this case are that, number one,
·6· · · ··Viridis North and Viridis Laboratories are two
·7· · · ··separate and distinct entities that the CRA has
·8· · · ··continuously treated as one entity as far as all of
·9· · · ··their testing methods.
10· · · · · · · · ··The evidence is going to show that those
11· · · ··labs are owned and operated in part by three former
12· · · ··Michigan State Police officers with a combined 75
13· · · ··years experience in forensic audit science.··And
14· · · ··because of that experience and because of the fact
15· · · ··that these are state-of-the-art facilities they
16· · · ··garnered a large amount of the market share
17· · · ··immediately.··Up to 60 percent prior to the
18· · · ··November 2021 recall.
19· · · · · · · · ··Because of that the other 17 laboratories
20· · · ··alleged numerous complaints that were found to be
21· · · ··unfounded that the CRA ran with and that this Court
22· · · ··will hear testimony about.··And most -- the biggest
23· · · ··complaint that was alleged related to potency.
24· · · · · · · · ··And Ms. Hunt-Scully in her opening
25· · · ··statement referenced a correspondence in 2020, it

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·1· · · ··was an email in 2020, as to the potency actually
·2· · · ··being too low at Viridis, and that's correct.··That
·3· · · ··email was sent and there was a corrective action
·4· · · ··plan you'll hear testimony about in 2020.
·5· · · · · · · · ··And frankly, if that were the complaint
·6· · · ··that we were here on, I think that it may have --
·7· · · ··that may be the only accurate science that you'll
·8· · · ··hear from the CRA.··And as a good -- as two good
·9· · · ··laboratories, from that point the Viridis
10· · · ··Laboratories optimized their method, as good
11· · · ··laboratories do.··They optimized their method.
12· · · · · · · · ··The optimization of the method didn't
13· · · ··require a new validation.··It didn't require a new
14· · · ··SOP.··But in November of 2020 the CRA through
15· · · ··Claire Patterson sent an email to Viridis, and at
16· · · ··that point is when they indicated that potency
17· · · ··levels were too high.··They didn't know why.
18· · · ··Claire Patterson in the email says something's
19· · · ··amiss.··They don't know what it is.
20· · · · · · · · ··So there's emails back and forth that
21· · · ··you'll see between Claire Patterson and Dr. Michele
22· · · ··Glinn from Viridis.··Claire Patterson indicates
23· · · ··they're auditing for potency that's too high
24· · · ··although they don't know -- they don't have any
25· · · ··reason to believe that there's anything wrong with

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·1· · · ··the method being used, asks Dr. Glinn to update the
·2· · · ··SOP.··Dr. Glinn provides on November 24th, 2020, an
·3· · · ··updated SOP for potency.··It's accepted by Claire
·4· · · ··Patterson.··Again on December 3rd, 2020, she sends
·5· · · ··it again.··It's accepted by Claire Patterson.
·6· · · ··There's no rejection of it.
·7· · · · · · · · ··Now, I know on the opening statement by
·8· · · ··Ms. Hunt-Scully referenced that there's a --
·9· · · ··there's a procedure in place for acceptance of
10· · · ··SOPs.··Well, the testimony will show actually that
11· · · ··SOPs are received through emails and they are
12· · · ··accepted through emails.··But it's not just the
13· · · ··email that was received and the fact that there
14· · · ··wasn't any response to it in November 2020 or
15· · · ··December 3rd, 2020.
16· · · · · · · · ··You fast-forward to December 22nd, 2020,
17· · · ··Ms. Hunt-Scully in her opening statement makes
18· · · ··reference to this semi-annual inspection.··Now, the
19· · · ··semi-annual inspection is something that all the
20· · · ··laboratories go through.··And we have two lab
21· · · ··scientists from the CRA that testified during their
22· · · ··deposition that the purpose of the semi-annual
23· · · ··inspection is to confirm that laboratories are
24· · · ··complying with the administrative rules.
25· · · · · · · · ··Both laboratories are watched conducting

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·1· · · ··their potency method using this December 3rd, 2020,
·2· · · ··method.··At the end of the semi-annual inspection
·3· · · ··they receive any deficiencies.··Part of those
·4· · · ··deficiencies -- and as part of that they're
·5· · · ··required to produce a response to the deficiencies.
·6· · · ··Part of that in Number 12 that you'll see in that
·7· · · ··semi-annual inspection is related to a possible
·8· · · ··deficiency for a proposed rule violation for not
·9· · · ··following the SOP.
10· · · · · · · · ··Viridis Laboratories, Viridis North both
11· · · ··respond to that deficiency stating the method
12· · · ··hasn't changed, the SOP that was sent on December
13· · · ··3rd is still in use, which is the method that they
14· · · ··watched.
15· · · · · · · · ··The express response to that is response
16· · · ··accepted.··Passed semi-annual inspection Viridis
17· · · ··North.··Passed semi-annual inspection in Viridis
18· · · ··Laboratories.··That is the end result.··They're
19· · · ··passed in both laboratories.··They know -- the CRA
20· · · ··knows this is the method they're using.··They watch
21· · · ··them use it.··They bring up the issue in their
22· · · ··deficiency.··Both Viridis Laboratories respond
23· · · ··telling them what they're using.··They accept that
24· · · ··response and move forward.
25· · · · · · · · ··Viridis knows nothing that there's an

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·1· · · ··investigation that's being launched.··And there's
·2· · · ··an investigative report that you'll see from March
·3· · · ··2020.
·4· · · · · · · · ··Fast-forward to June 2021.··That's the
·5· · · ··next semi-annual inspection.··At this point neither
·6· · · ··Viridis laboratory has received nothing from the
·7· · · ··CRA saying your method's not approved.··You
·8· · · ··shouldn't be -- you shouldn't be using this method.
·9· · · · · · · · ··The CRA wants to come in here today and
10· · · ··during this hearing, the testimony you're going to
11· · · ··hear, they want you to believe that Viridis just
12· · · ··should have known that notwithstanding the response
13· · · ··and the acceptance and the passing of the December
14· · · ··2020 semi-annual inspection.··It makes no sense.
15· · · ··If the CRA is really cornered about the health and
16· · · ··safety, they certainly would have told Viridis
17· · · ··Laboratories that they were using a method that
18· · · ··wasn't approved.··But they didn't.··The only thing
19· · · ··that was received was in June 2021 they receive a
20· · · ··method validation review that claims that the
21· · · ··validation is not complete and it doesn't comply
22· · · ··with Appendix K from the AOAC.··It's not tied to
23· · · ··any validation whatsoever.··And that's the end of
24· · · ··June 2021.
25· · · · · · · · ··Fast-forward to July 13th, 2021.··They

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·1· · · ··receive passing semi-annual inspections for both
·2· · · ··labs.··Again, the CRA had viewed both laboratories
·3· · · ··doing the potency method.··Between November 2020 to
·4· · · ··October 2021 the CRA watched the various
·5· · · ··laboratories do the method four times and approved
·6· · · ··it 14 times.
·7· · · · · · · · ··Notwithstanding that fact on August 25th,
·8· · · ··2021, the CRA issues the first formal complaint
·9· · · ··which is superseded by, in this case, with a
10· · · ··potency complaint.··This Court had to enter -- this
11· · · ··Tribunal had to enter a protective order on that
12· · · ··complaint because the allegations were so
13· · · ··salacious, and it provided the proprietary
14· · · ··information from the Viridis method.
15· · · · · · · · ··Now, the salacious allegations, the
16· · · ··testimony that you're going to hear from the CRA
17· · · ··scientists is not just that they were using an SOP,
18· · · ··an approved SOP method, their allegations go way
19· · · ··farther than that.··Their allegations are going to
20· · · ··say this was fraud.··The allegations from
21· · · ··Dr. Chirio are going to say they were receiving
22· · · ··money to inflate potency.
23· · · · · · · · ··These outlandish allegations are shown
24· · · ··false by the one thing that Ms. Hunt-Scully never
25· · · ··mentioned in her opening statement, the AOAC

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·1· · · ··certification.
·2· · · · · · · · ··Dr. Chirio prior to knowing that the
·3· · · ··certification was going to be issued by the AOAC
·4· · · ··testified that the AOAC is the gold standard.··And
·5· · · ··she'll testify that if the AOAC approves a method,
·6· · · ··it is tried and true.
·7· · · · · · · · ··She was asked during her deposition if
·8· · · ··the AOAC were to come in and say that this potency
·9· · · ··method was correct would you agree with that.··In
10· · · ··the millionth chance that they would state that,
11· · · ··yes, I would agree with that.··Well, here we are.
12· · · ··They did.
13· · · · · · · · ··In fact, the AOAC not only approved the
14· · · ··method they specifically showed what the CRA will
15· · · ··argue here today was false.··They state in the AOAC
16· · · ··certification "Therefore recovering resin from the
17· · · ··grinding media does not artificially inflate
18· · · ··cannabinoid levels.··On the contrary, the use of
19· · · ··material from the grinding media only partially
20· · · ··recovers that which is displaced during the
21· · · ··homogenization process."
22· · · · · · · · ··The CRA had claimed in this August 25th,
23· · · ··2021, formal complaint it was fraud.··They were
24· · · ··purposely inflating potency.··The AOAC came in in
25· · · ··October 2022, made this method the only marijuana

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·1· · · ··potency testing method certified in the entire
·2· · · ··world.··Even after that you're going to hear
·3· · · ··testimony that the CRA still didn't want to allow
·4· · · ··the use of it.··Why not?··Because the testimony's
·5· · · ··going to show that if they did it would show that
·6· · · ··their -- their scientists and what their
·7· · · ··allegations were all false.··Which they were.··And
·8· · · ··that will be shown.
·9· · · · · · · · ··At the end of the day they approved a
10· · · ··method that went from November to August without
11· · · ··any -- any call, any email, nothing from the CRA to
12· · · ··say this method isn't sound.··They let them use
13· · · ··this method because it was sound.··And it was
14· · · ··proven later by the AOAC certification.
15· · · · · · · · ··Then move into 2021 you'll see the
16· · · ··investigation start.··In September of 2021 there's
17· · · ··emails from CRA scientists who -- experts, outside
18· · · ··experts, starting to build the case.··And those are
19· · · ··their words.··Build a case as it relates to
20· · · ··microbials.··They're asking about ISO
21· · · ··accreditation, ISO issues and incubation issues.
22· · · ··Things that they don't know about, that they don't
23· · · ··understand.··So they're searching to build a case.
24· · · · · · · · ··And so they notify Viridis Laboratories
25· · · ··and Viridis North that they're going to come on

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·1· · · ··site in October of 2021, which they do, they come
·2· · · ··on site.··One of the issues that they allege is a
·3· · · ··violation is this foreign matter that they put in
·4· · · ··their complaint.··The foreign matter is tested
·5· · · ··through a grid that Dr. Michele Glinn will explain.
·6· · · ··And their allegation is even though that Dr. Chirio
·7· · · ··was basically standing over their shoulder that
·8· · · ··they were falsifying the results by not -- by not
·9· · · ··finding that -- foreign matter presence when, in
10· · · ··fact, they did comply specifically with their SOP.
11· · · · · · · · ··In addition to try to support that
12· · · ··allegation they used video recordings which,
13· · · ··interestingly enough when it comes to the microbial
14· · · ··issue, when Viridis offered to show video
15· · · ··recordings that it was, in fact, done properly,
16· · · ··that the incubation times were correct, the CRA
17· · · ··wouldn't allow that and said they weren't able to
18· · · ··do that.
19· · · · · · · · ··After the October 2021 audits the
20· · · ··testimony will show that the CRA used those audits
21· · · ··to eventually issue a recall in November 2021.
22· · · · · · · · ··Now, the allegations set forth in the
23· · · ··complaint as it relates to the microbials, and this
24· · · ··was part of our motion for summary disposition -- I
25· · · ··know that's been stricken from the record, but I

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·1· · · ··think it's important.··We'll see it and we'll see
·2· · · ··the Court of Claims opinion on it.··There was two
·3· · · ··days of evidentiary hearing.··What the CRA's
·4· · · ··position is, is that there were incubation logs
·5· · · ··that were required, time logs for in and out for
·6· · · ··the incubation periods.··Dr. Murray and Judge
·7· · · ··Cameron specifically ruled that there's no SOP,
·8· · · ··there's no rule, that's no statute that requires
·9· · · ··it.··The matter has been litigated as it relates to
10· · · ··that.
11· · · · · · · · ··The second thing that they rely on are
12· · · ··these retests that required Viridis to send out
13· · · ··tests that they had passed to other laboratories.
14· · · ··On the day of the recall on November 17th, 2021,
15· · · ··two industry experts that had been recognized by
16· · · ··Claire Patterson as experts, Pat Bird from the AOAC
17· · · ··and Maria McIntyre from bioMérieux who is the
18· · · ··vendor of the platform that tests aspergillus,
19· · · ··stated to Desmond Mitchell from the CRA retests are
20· · · ··not an accurate way to make a determination as to
21· · · ··the reliability of the tests that will not support
22· · · ··recall.
23· · · · · · · · ··Now, they went forward and, obviously,
24· · · ··issued the recall.··But in the discovery in this
25· · · ··case Dr. Allyson Chirio, the CRA's own scientist,

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·1· · · ··testified that she agreed with Pat Bird and Maria
·2· · · ··McIntyre and, in fact, those retests would not be a
·3· · · ··reliable way to make a determination as to whether
·4· · · ··the test was accurate or not.
·5· · · · · · · · ··So in order for the CRA to prove that
·6· · · ··claim they're actually going to have to put someone
·7· · · ··on the stand to dispute a factual assertion made
·8· · · ··but their own lab scientist Dr. Allyson Chirio.
·9· · · · · · · · ··So those issues have already been
10· · · ··litigated or the CRA has already -- has testimony
11· · · ··that they're not accurate.··There's no rule,
12· · · ··there's no SOP that's violated if aspergillus is
13· · · ··passed without remediation when it's sent to
14· · · ··another lab.
15· · · · · · · · ··Claire Patterson testified to the core
16· · · ··claims.··That is allowed.··A lab can send to
17· · · ··another lab to have retested.··There's no rule that
18· · · ··requires a showing of remediation on it.
19· · · · · · · · ··We'll get into proficiency testing.··The
20· · · ··proficiency testing will show that Viridis
21· · · ··Laboratories had an excellent track record when it
22· · · ··came to testing aspergillus.··The testimony and
23· · · ··evidence will show that the CRA put together data
24· · · ··based on Metrc which they used to attempt to show
25· · · ··that Viridis's fail rates were much lower than the

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·1· · · ··average of the rest of the industry in the state of
·2· · · ··Michigan.··That will be shown to be completely
·3· · · ··false.
·4· · · · · · · · ··At the end of the testimony what this
·5· · · ··Tribunal's going to see is there was confirmation
·6· · · ··bias.··The CRA wanted to find a result when it came
·7· · · ··to potency, when it came to foreign matter, and
·8· · · ··when it came to microbials, and they found a way to
·9· · · ··do it.··But at the end of the day the testimony is
10· · · ··going to show that Viridis Laboratories and Viridis
11· · · ··North complied with their SOPs.··Did not violate
12· · · ··any administrative rules or any statute.
13· · · · · · · · ··Thank you.
14· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you, Counsel.
15· · · · · · · · ··Ms. Hunt-Scully, your opening on the --
16· · · ··or actually, you know, unnecessary disruption case
17· · · ··Viridis has the burden.
18· · · · · · · · ··MR. RUSSELL:··Yeah, Your Honor, I
19· · · ··would -- if you don't mind, I'd prefer to do that
20· · · ··at the opening of our case in chief on that.
21· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.
22· · · · · · · · ··Ms. Hunt-Scully, did you wish to do
23· · · ··opening on that now or do you wish to just respond
24· · · ··when they do theirs?
25· · · · · · · · ··MS. HUNT-SCULLY:··Your Honor, I would

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·1· · · ··prefer to do my opening after I hear Mr. Russell's.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··After they give theirs?
·3· · · · · · · · ··MS. HUNT-SCULLY:··Yes.··Because they do
·4· · · ··have the burden, yeah.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··That's fine.
·6· · · · · · · · ··MS. HUNT-SCULLY:··And, Your Honor, we do
·7· · · ··have our first witness I think in the waiting room.
·8· · · ··But I apologize, I know it's still early in the
·9· · · ··morning, but I could really use a break,
10· · · ··five-minute break.
11· · · · · · · · ··JUDGE GOLDSTEIN:··That's fine.··We have
12· · · ··been going over an hour already.··So why don't we
13· · · ··break till 10:10.··Ten minutes okay?
15· · · · · · · · ··MR. RUSSELL:··Yes.··Thank you.
16· · · · · · · · ··JUDGE GOLDSTEIN:··We'll reconvene at
17· · · ··10:20.··Off the record at 10:10.
18· · · · · · · · ··MS. HUNT-SCULLY:··Thank you.
19· · · · · · · · ··(Break taken at 10:10 AM)
20· · · · · · · · ··(Break concluded at 10:22 AM)
21· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Back on the
22· · · ··record in the matter of Viridis Laboratories, LLC,
23· · · ··and Viridis North, LLC, versus Cannabis Regulatory
24· · · ··Agency, consolidated Docket Numbers 21-029794,
25· · · ··et al.

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·1· · · · · · · · ··All right, Counsel.
·2· · · · · · · · ··MR. RUSSELL:··Yes.··Thank you, Your
·3· · · ··Honor.
·4· · · · · · · · ··I know we raised this in the motion for
·5· · · ··summary disposition and the Court has stricken
·6· · · ··that, which I understand, and I'm not asking it to
·7· · · ··revisit it, but I would like clarification if
·8· · · ··possible that the issue on the AOAC certification
·9· · · ··has never -- has not now been addressed by the CRA
10· · · ··on whether they're past October 2022 whether
11· · · ··they're taking the position that the -- that's not
12· · · ··an approved method.
13· · · · · · · · ··JUDGE GOLDSTEIN:··What are you asking the
14· · · ··Tribunal to do?
15· · · · · · · · ··MR. RUSSELL:··I'm asking for
16· · · ··clarification, I guess, from -- I think it makes
17· · · ··sense before as a preliminary method that counsel
18· · · ··could tell the Court whether that they're still
19· · · ··taking the position today that the SOP is not --
20· · · ··there's not an approved SOP.··There's not an
21· · · ··approved method.
22· · · · · · · · ··JUDGE GOLDSTEIN:··Ms. Hunt-Scully, do you
23· · · ··understand what he's asking?
24· · · · · · · · ··MS. HUNT-SCULLY:··I think I do.··And,
25· · · ··your Honor, to be honest, I don't think it's fair

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·1· · · ··for me to portray whether they believe that the
·2· · · ··method has been validated to what's required or not
·3· · · ··validated to be required.··I think that's for the
·4· · · ··CRA witnesses to provide testimony to.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··That's fair.
·6· · · · · · · · ··Counsel, I understand -- I understand
·7· · · ··both sides' concerns here.··I mean, that has been
·8· · · ··raised, so I guess that can be elicited during
·9· · · ··testimony.
10· · · · · · · · ··MR. RUSSELL:··Thank you, your Honor.··I
11· · · ··was just trying to narrow issues if possible.
12· · · · · · · · ··JUDGE GOLDSTEIN:··I understand, and I
13· · · ··appreciate it, but that puts Ms. Hunt-Scully on the
14· · · ··spot a bit.
15· · · · · · · · ··Anything else before we start with the
16· · · ··first witness?
17· · · · · · · · ··MS. HUNT-SCULLY:··Yes, your Honor.··I do
18· · · ··have an issue I'd like to bring to the Tribunal's
19· · · ··attention.
21· · · · · · · · ··MS. HUNT-SCULLY:··And so I know that, you
22· · · ··know, before break and, you know, since then I've
23· · · ··had, you know, a few minutes to reflect and think
24· · · ··about it again that Mr. Russell asked to reserve
25· · · ··his opening statement as far as the disruption

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·1· · · ··complaint, and -- and of course I should be able to
·2· · · ··give my remarks after whatever he says.··But in
·3· · · ··the -- when we met for a prehearing conference in
·4· · · ··November of 2022 and then this Tribunal issued an
·5· · · ··order consolidating these cases, but the method
·6· · · ··outlined by the Tribunal during that prehearing
·7· · · ··conference was that we would call each witness and
·8· · · ··glean every bit of testimony that we could possibly
·9· · · ··can regarding both the discipline complaints and
10· · · ··the disruption complaints and we would preface, you
11· · · ··know, and if we could, to the extent possible,
12· · · ··which complaint or whether it applied to both, the
13· · · ··testimony applied to.
14· · · · · · · · ··And so I expect that Mr. Russell will be
15· · · ··asking the CRA witnesses that we intend to call
16· · · ··here first about the disruption complaint because
17· · · ··of this Tribunal's order regarding consolidation in
18· · · ··expectation of how we would elicit testimony from
19· · · ··each witness.··So I do think that if Mr. Russell
20· · · ··chooses to give an opening statement it should be
21· · · ··now before what I believe should be starting both
22· · · ··cases or all cases.
23· · · · · · · · ··MR. RUSSELL:··Your Honor, I don't believe
24· · · ··that was what was agreed to.··I do agree we're not
25· · · ··going to recall these witnesses, but it was my

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·1· · · ··understanding and that's how I prepared for this
·2· · · ··was that prior to our case in chief that we will be
·3· · · ··calling witnesses that I would provide an opening
·4· · · ··statement at that time.··I don't know how that
·5· · · ··prejudices the CRA or -- in any way.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··You know --
·7· · · · · · · · ··MS. HUNT-SCULLY:··Oh, I don't mean to
·8· · · ··speak out of turn, I'm sorry, but, you know, then
·9· · · ··if that's Mr. Russell's intent, then I don't think
10· · · ··that he should be able to ask the CRA witnesses
11· · · ··that we call for our discipline complaints anything
12· · · ··about the disruption complaint if he's not yet
13· · · ··putting proofs on for the disruption complaint.
14· · · · · · · · ··MR. RUSSELL:··I will ask them questions
15· · · ··as we've talked about.
16· · · · · · · · ··JUDGE GOLDSTEIN:··That's not necessary,
17· · · ··no.··We don't have a jury here.··We don't -- my
18· · · ··understanding of the unnecessary disruption
19· · · ··complaint is that it is directly related, for the
20· · · ··most part, to the four superseding complaints filed
21· · · ··by the Agency against Viridis.··Okay?··The
22· · · ··background information, how this all started, the
23· · · ··competitive -- the claims that competitors are
24· · · ··behind this, competitors' lab testing companies.
25· · · · · · · · ··Now, if you have questions about your --

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·1· · · ··on cross-examination about your unnecessary
·2· · · ··disruption complaint that are directly related to
·3· · · ··the subject and the testimony that the witness is
·4· · · ··talking about, for example not following SOP, I
·5· · · ··can -- I can tell you're asking questions about
·6· · · ··unnecessary disruption.··Okay?
·7· · · · · · · · ··I mean, the unnecessary disruption claim
·8· · · ··is, in part at least, from what I understand, is
·9· · · ··you've performed according to an SOP that you
10· · · ··thought the Agency had passed and had approved.
11· · · ··Okay?··And now we have this.··Okay?
12· · · · · · · · ··And the recall -- so, you know, I don't
13· · · ··think we need to separate out the opening and
14· · · ··closing remarks since, number one, they're only
15· · · ··argument, they're not evidence, and the Tribunal's
16· · · ··capable of parsing out the information otherwise.
17· · · · · · · · ··So you can make your opening before your
18· · · ··chief, your case in chief, on the unnecessary
19· · · ··disruption.··We'll proceed as planned.
20· · · · · · · · ··MR. RUSSELL:··Thank you, your Honor.
21· · · · · · · · ··JUDGE GOLDSTEIN:··Anything else,
22· · · ··Ms. Hunt-Scully?
23· · · · · · · · ··MS. HUNT-SCULLY:··No, your Honor.
25· · · · · · · · ··MS. HUNT-SCULLY:··Just for the Tribunal's

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·1· · · ··awareness, Ms. Huyser will be taking the first
·2· · · ··witness.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··And is that
·4· · · ··Ms. Patterson?
·5· · · · · · · · ··MS. HUYSER:··It is, Your Honor.··I
·6· · · ··believe she's in the waiting room already.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··She's been in the
·8· · · ··waiting room for a while.··Okay, I'm admitting her
·9· · · ··now.··Okay.
10· · · · · · · · ··MS. HUYSER:··Thank you.
11· · · · · · · · ··JUDGE GOLDSTEIN:··I wasn't certain if she
12· · · ··should be hearing all this or not so we kept her in
13· · · ··the waiting room.
14· · · · · · · · ··MR. RUSSELL:··And, Your Honor, I guess,
15· · · ··that's a good point, and I -- well, it doesn't
16· · · ··matter, she was in the waiting room, so that's
17· · · ··fine.
18· · · · · · · · ··MS. HUYSER:··Before we start witnesses if
19· · · ··it makes it a little simpler we have instructed our
20· · · ··witnessed about a sequestration order, so we have
21· · · ··no problem if we want to just place that on the
22· · · ··record if that's what Ms. Russell was getting at.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Is that what you were
24· · · ··getting at, Ms. Russell?
25· · · · · · · · ··MR. RUSSELL:··No, I have no issue with --

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·1· · · ··I don't think a sequestration is necessary.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Good morning,
·3· · · ··Ms. Patterson.··You're on mute if you can unmute
·4· · · ··yourself.··We're not hearing you.
·5· · · · · · · · ··MS. PATTERSON:··Can you hear me now?
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Now we hear you.
·7· · · · · · · · ··MS. PATTERSON:··Okay.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Would you raise
·9· · · ··your right hand for me.
10· · · · · · · · ··Do you solemnly swear or affirm to tell
11· · · ··the truth, the whole truth, and nothing but the
12· · · ··truth?
13· · · · · · · · ··MS. PATTERSON:··I do.
14· · · · · · · · · · ··CLAIRE PATTERSON
15· · · ··a witness herein, was called for examination, and
16· · · ··after having been sworn, was examined and testified
17· · · ··on her oath as follows:
18· · · · · · · · ··JUDGE GOLDSTEIN:··Could you state and
19· · · ··spell your first and last name for me, please.
20· · · · · · · · ··THE WITNESS:··Claire Patterson.
21· · · ··C-l-a-i-r-e, P-a-t-t-e-r-s-o-n.
22· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you.
23· · · · · · · · ··All right, Ms. Huyser, go ahead.
24· · · · · · · · ··MR. RUSSELL:··Your Honor, and I hate to
25· · · ··interrupt.··I really apologize, Ms. Huyser.

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·1· · · · · · · · ··One thing, because you brought that up
·2· · · ··about the sequestration order, I just want to make
·3· · · ··the Tribunal aware, although you can't see on
·4· · · ··camera, Dr. Michele Glinn and Greg Michaud are in
·5· · · ··this conference room that we are in right now.··So
·6· · · ··I guess I want to add if there's any objections,
·7· · · ··that put on the record at this point.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Those are --
·9· · · ··Mr. Michaud and Mr. -- I'm sorry, Ms. -- who's the
10· · · ··other person?
11· · · · · · · · ··MR. RUSSELL:··Dr. Michele Glinn.
12· · · · · · · · ··JUDGE GOLDSTEIN:··Dr. Glinn, they are
13· · · ··your -- Mr. Michaud is -- he's the owner I think.
14· · · ··Right?··CEO?
15· · · · · · · · ··MR. RUSSELL:··Correct.··Yes.··They are
16· · · ··corporate reps for each of the two laboratories.
18· · · · · · · · ··MR. RUSSELL:··So I believe they have the
19· · · ··ability to be in the room.··And I understand -- we
20· · · ··don't have any other witnesses that are listening
21· · · ··in or on this.··So to the extent that a
22· · · ··sequestration is necessary, that's fine.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah.··No, that's -- I
24· · · ··guess that's nice with technology we can exclude.
25· · · ··Nobody else is listening in.

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·1· · · · · · · · ··MS. HUYSER:··And just --
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Is that okay,
·3· · · ··Ms. Hunt-Scully and Ms. Huyser?
·4· · · · · · · · ··MS. HUYSER:··Just to be make sure I'm
·5· · · ··clear, both Dr. Glinn and Mr. Michaud are planning
·6· · · ··on testifying at least for the disruption
·7· · · ··complaint; correct?
·8· · · · · · · · ··MR. RUSSELL:··I'm sorry.··Yes, they are.
·9· · · ··For both.··In defense of the complaints brought by
10· · · ··the CRA as well as in the case in chief.
11· · · · · · · · ··MS. HUYSER:··At this point in time I
12· · · ··think I would request a sequestration order just
13· · · ··for the sake of if we are going to have them
14· · · ··present.··I apologize for not asking sooner I
15· · · ··didn't realize they were in the room with you.
16· · · · · · · · ··MR. RUSSELL:··Your Honor, these are
17· · · ··corporate reps.··They have the right to be present
18· · · ··for each laboratory.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··They will be
20· · · ··allowed to remain.··They are corporate
21· · · ··representatives and they will ultimately be
22· · · ··witnesses.··That's no prohibition then.
23· · · · · · · · ··MS. HUNT-SCULLY:··Your Honor, as far as
24· · · ··other witnesses we would ask for an order of
25· · · ··sequestration though.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··That's fine.
·2· · · ··Typically we -- the Tribunal will allow for at
·3· · · ··least one representative for each entity so . . .
·4· · · · · · · · ··MR. RUSSELL:··And we have no objection to
·5· · · ··the other -- any other witnesses, Your Honor.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Thank you.
·7· · · · · · · · ··All right, Ms. Huyser, go ahead.
·8· · · · · · · · ··MS. HUYSER:··Thank you.
·9· · · · · · · · · · ··DIRECT EXAMINATION
10· ·BY MS. HUYSER:
11· ·Q· ··Dr. Patterson, can you hear me okay?
12· ·A· ··Yes, ma'am, I can.
13· ·Q· ··Thank you.··Can you please tell me where you're
14· · · ··employed?
15· ·A· ··I'm employed at the Cannabis Regulatory Agency.
16· ·Q· ··And what do you do there?
17· ·A· ··I currently manage the scientific section.
18· ·Q· ··And can you tell me a little bit about just what
19· · · ··your day-to-day job functions are?··What do you do?
20· ·A· ··Right now I oversee both laboratory scientist
21· · · ··specialists as well as investigative analysts, and
22· · · ··typically I oversee operations of cannabis
23· · · ··licensees.
24· · · · · · · · ··On the analyst side we oversee
25· · · ··cultivators, processors, retail locations.··We're

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·1· · · ··very heavily involved in reviewing Metrc.
·2· · · · · · · · ··And then on the laboratory scientist
·3· · · ··specialist side I oversee those staff.··And they in
·4· · · ··particular oversee the operations of all safety
·5· · · ··compliance facilities or laboratories here in the
·6· · · ··state of Michigan that test and oversee the,
·7· · · ··essentially, sale of cannabis and cannabis-infused
·8· · · ··products.
·9· ·Q· ··I know this is going to sound like a silly question
10· · · ··as I go through this, but when we say oversee, are
11· · · ··you actively involved in the investigations,
12· · · ··day-to-day operations, or what do you do?
13· ·A· ··So typically in terms of oversight I oversee my
14· · · ··staff in terms of just a management role and
15· · · ··oversee the activities that they perform.··They are
16· · · ··typically more involved in the hands-on oversight
17· · · ··investigative things.··You know, data review,
18· · · ··method reviews, things of that nature.··However,
19· · · ··there are occasions where I do have to get
20· · · ··involved.··That may be in the case of
21· · · ··investigations or more complex method reviews.
22· · · ··Items that would require a manager, oversight or
23· · · ··manager approval I will step in.
24· ·Q· ··How long have you been with the Cannabis Regulatory
25· · · ··Agency?

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·1· ·A· ··I have been with the Cannabis Regulatory Agency
·2· · · ··since March of 2019.
·3· ·Q· ··What was your title when you began your employment?
·4· ·A· ··When I first began my employment here I was
·5· · · ··employed as a laboratory scientist specialist.
·6· ·Q· ··Is that what is commonly referred to as an LSS?
·7· ·A· ··Yes, it is.
·8· ·Q· ··What were your job functions as an LSS?
·9· ·A· ··As an LSS it was my duty to oversee all of the
10· · · ··operations, compliance of our licensed laboratories
11· · · ··at that time and throughout the course of my career
12· · · ··as an LSS as well.··So I would do things such as
13· · · ··reviewing testing data in Metrc.··Approve methods.
14· · · ··Review method verifications and method validations.
15· · · ··Correspond with laboratories.··Answer questions.
16· · · ··Help them get through the prelicensure process.
17· · · ··Perform inspections.··And really just assisting the
18· · · ··laboratories in their operations to ensure that
19· · · ··they were compliant with the rules of the Agency.
20· ·Q· ··What was the state of the marijuana market when you
21· · · ··started in 2019?
22· ·A· ··It was a little bit -- and I think a lot of folks
23· · · ··say this -- a little bit like the Wild Wild West.
24· · · ··Obviously, you know, we had some laws in place that
25· · · ··were not being overseen at that time, or just began

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·1· · · ··to be overseen at that time rather.··And so folks
·2· · · ··were really just kind of getting their feet under
·3· · · ··them.··The Agency was really getting their feet
·4· · · ··under them as well.
·5· · · · · · · · ··I think everyone was very new to the
·6· · · ··regulatory space.··And for anyone familiar with the
·7· · · ··cannabis industry there was -- it was a transition
·8· · · ··period I will say.··It was -- it was tough to get
·9· · · ··everybody on board and make sure that folks were
10· · · ··educated in the way that they need to be so that
11· · · ··they could be compliant with the rules and
12· · · ··regulations.
13· ·Q· ··Can you tell me a little bit about where you were
14· · · ··employed before you started with the CRA?
15· ·A· ··Yes, I can.
16· · · · · · · · ··So directly before I was employed with
17· · · ··the CRA I was employed as Michigan State
18· · · ··University.··I was a research technician and
19· · · ··laboratory manager for one of the largest plant
20· · · ··pathogen programs there.··During my time there we
21· · · ··oversaw national plant pesticide trials and set up,
22· · · ··really, these enormous research studies for folks
23· · · ··like Bayer and BASF.··Reported out data and did all
24· · · ··the testing for those things.
25· · · · · · · · ··And then prior to that I was employed as

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·1· · · ··an independent consultant for a period of time.··I
·2· · · ··worked, well, with Iron Laboratories, who is a
·3· · · ··licensed safety compliance facility now, I assisted
·4· · · ··them in coming into compliance with their ISO 17025
·5· · · ··requirements to ensure that they could get
·6· · · ··licensure with the State of Michigan as that
·7· · · ··process was kind of in the works at that period of
·8· · · ··time.
·9· · · · · · · · ··Prior to that I was also employed at
10· · · ··Michigan State University.··I oversaw their
11· · · ··biological sciences program and all laboratory
12· · · ··testing for Michigan State University and all of
13· · · ··their introductory programs, essentially, all their
14· · · ··freshman and sophomore classes.
15· · · · · · · · ··And then prior to that I was employed at
16· · · ··Iron Laboratories full-time as a laboratory
17· · · ··manager, for the assurance manager and plant
18· · · ··pathologist.
19· ·Q· ··What is plant pathology?
20· ·A· ··Plant pathology is the study of plant diseases.··So
21· · · ··plants, much like humans, are susceptible to a wide
22· · · ··range of diseases, and those are pathogens is what
23· · · ··we call those.··Those might be things like
24· · · ··bacterial infections, fungal infections, things of
25· · · ··that nature.··And I have studied that since -- gee

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·1· · · ··whiz.··For a very long time.··2008.
·2· ·Q· ··Do you have -- what is your educational background
·3· · · ··as it relates to studying these?
·4· ·A· ··So my bachelor's degree is in plant biology and
·5· · · ··environmental biology, and then my graduate degree
·6· · · ··is in plant biology, plant pathology, and then
·7· · · ··ecology, evolution, and behavioral biology.
·8· ·Q· ··And how does this relate to what you're doing now?
·9· ·A· ··This directly relates to what I'm doing now.
10· · · · · · · · ··So when I actually was in my both
11· · · ··undergraduate and graduate degrees folks would
12· · · ··always joke during that time, like, are you going
13· · · ··to grow up and study cannabis?··Obviously, given
14· · · ··it's legal status, I, of course, was, like, no, no,
15· · · ··of course not.··But as it turns out it actually
16· · · ··translates directly to what I'm doing now.
17· · · · · · · · ··I know everything about the cannabis
18· · · ··plant, cannabis science, cannabis biochemistry, and
19· · · ··that comes through my study of plant biology and my
20· · · ··study of plant pathology.
21· ·Q· ··Are you engaged in any ongoing education in your
22· · · ··role?
23· ·A· ··I am engaged in ongoing education.··Formally, since
24· · · ··I've been in this role, actually, I've undergone
25· · · ··ISO 17025 auditor training.··And then additionally,

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·1· · · ··you know, as various investigative trainings or
·2· · · ··things like that come up throughout the Agency I
·3· · · ··participate in those to also, you know, better
·4· · · ··inform myself but also to make sure that my staff
·5· · · ··are being overseen and properly trained as well.
·6· · · · · · · · ··And then on top of that just in terms of
·7· · · ··general education I am a chair of the laboratory
·8· · · ··testing and safety, product safety, committee for
·9· · · ··the Cannabis Regulators Association as well.··So in
10· · · ··that role I also speak with regulators throughout
11· · · ··the nation about cannabis, cannabis testing, and
12· · · ··the landscape that we're facing at the national
13· · · ··level.
14· ·Q· ··And you mentioned you were on that board.··Are you
15· · · ··on any other boards other than the CANRA board?
16· ·A· ··I primarily serve actively on the CANRA board right
17· · · ··now, although I am also on the Cannabis Analytical
18· · · ··Sciences Program board for proficiency testing as
19· · · ··well as microbials.
20· ·Q· ··And what does that board do?
21· ·A· ··So the Cannabis Analytical Sciences Program is
22· · · ··administered under the AOAC.··That's a group that
23· · · ··has been put together to, essentially, solve
24· · · ··problems in cannabis testing.
25· · · · · · · · ··It's a very new field and so it's very

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·1· · · ··important that we have folks from -- throughout the
·2· · · ··industry, honestly, working together to figure out
·3· · · ··how to solve these complex scientific issues.
·4· · · · · · · · ··So in proficiency testing one of the
·5· · · ··biggest issues that we face is the ability to have
·6· · · ··meaningful proficiency tests conducted.··So we're
·7· · · ··working on figuring out a program through which we
·8· · · ··can administer that.
·9· · · · · · · · ··And then on the microbial program we also
10· · · ··assess microbial methods that laboratories use in
11· · · ··their own states, in their own testing spaces, to
12· · · ··test for the presence of plant pathogens.
13· ·Q· ··Have you ever presented on any of these topics?
14· ·A· ··I have presented on a number of these topics a
15· · · ··number of times.
16· ·Q· ··And have you ever testified in court as an expert?
17· ·A· ··Yes, I have.
18· · · · · · · · ··MS. HUYSER:··And I'm going to share my
19· · · ··screen if I may, Your Honor.
20· · · · · · · · ··JUDGE GOLDSTEIN:··Let me make sure that
21· · · ··that's set correctly.··No, it wasn't.
22· · · · · · · · ··Go ahead.··Now you should be okay.
24· ·Q· ··(MS. HUYSER) Are you able to see that,
25· · · ··Ms. Patterson?

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·1· ·A· ··Yes, I am.··Thank you.
·2· ·Q· ··And let me scroll up to the top here.
·3· · · · · · · · ··As I scroll through do you recognize
·4· · · ··what's been marked as People's -- Petitioner's
·5· · · ··proposed Exhibit 52?
·6· ·A· ··I do, yes.
·7· ·Q· ··And what is it?
·8· ·A· ··That is my CV.
·9· ·Q· ··Okay.··And do you -- as I go through slowly do you
10· · · ··recognize any changes or alterations or anything
11· · · ··separate from the form that you originally provided
12· · · ··it to us?
13· ·A· ··No, I do not.
14· · · · · · · · ··MS. HUYSER:··Okay.··At this point in
15· · · ··time, Your Honor, I would ask that Petitioner's
16· · · ··proposed 52 be admitted.
17· · · · · · · · ··JUDGE GOLDSTEIN:··Any objection, Counsel?
18· · · · · · · · ··MR. RUSSELL:··No, Your Honor.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Petitioner Exhibit 52
20· · · ··is admitted.
21· · · · · · · · ··(CRA Exhibit 52 is admitted.)
22· · · · · · · · ··MS. HUYSER:··At this point in time, Your
23· · · ··Honor, I would also ask to have Claire Patterson
24· · · ··qualified as an expert in the field of plant
25· · · ··pathology.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Any voir dire?··Any
·2· · · ··objection, Counsel?
·3· · · · · · · · ··MR. RUSSELL:··I do have a little
·4· · · ··voir dire, Your Honor.
·5· · · · · · · · · ··VOIR DIRE EXAMINATION
·6· ·BY MR. RUSSELL:
·7· ·Q· ··I believe you just testified that you know
·8· · · ··everything about the plant.··Is that what you
·9· · · ··stated?
10· ·A· ··Yes, that is what I stated.
11· ·Q· ··Okay.··And so when you talk about the plant you're
12· · · ··testifying that you know everything about the
13· · · ··cannabis plant?
14· ·A· ··Cannabis, yes, sir.
15· ·Q· ··Okay.··And so is it your testimony then that
16· · · ··because you know everything about the plant you
17· · · ··also know everything about -- as it relates to
18· · · ··testing a cannabis plant?
19· ·A· ··Yes, sir.
20· ·Q· ··Now, do you recall in August 2021 signing a formal
21· · · ··complaint that was superseded by the complaint that
22· · · ··we're here for today?
23· ·A· ··Yes, sir.
24· ·Q· ··Okay.··And do you recall the salacious allegations
25· · · ··in that complaint that stated that Viridis

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·1· · · ··Laboratories and Viridis North were fraudulently
·2· · · ··reporting potency results?
·3· ·A· ··Yes, sir.
·4· ·Q· ··Okay.··And since that time you all read that the
·5· · · ··AOAC had certified the potency method in which the
·6· · · ··two Viridis laboratories are testing potency;
·7· · · ··correct?
·8· ·A· ··I am aware that that method meets the standard
·9· · · ··method performance requirements, yes, sir.
10· ·Q· ··Okay.··And so have you actually -- you've read the
11· · · ··certification itself; correct?
12· ·A· ··Yes, sir, I have.
13· ·Q· ··Okay.··And would it be fair to say that the
14· · · ··certification from the AOAC directly conflicts with
15· · · ··the CRA's findings as it relates to the method?
16· ·A· ··No, sir, it does not.
17· ·Q· ··Okay.··So when the AOAC says "Therefore recovering
18· · · ··resin from the grinding media does not artificially
19· · · ··inflate cannabinoid levels" would you agree with
20· · · ··that statement then?
21· ·A· ··I disagree with that statement, sir.··That
22· · · ··validation was incomplete.
23· ·Q· ··So what you're saying then is that the AOAC that
24· · · ··peer reviewed this with three outside experts
25· · · ··failed to properly validate it?

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·1· ·A· ··Yes, sir.
·2· · · · · · · · ··MR. RUSSELL:··Okay.··Your Honor, the AOAC
·3· · · ··from their own -- from the testimony from the CRA's
·4· · · ··own scientists have said it's the gold standard,
·5· · · ··and when their methods are approved, they're tried
·6· · · ··and true.
·7· · · · · · · · ··This witness has been -- opinion has been
·8· · · ··contradicted by the AOAC expressly in the
·9· · · ··certification.··I would object to this witness
10· · · ··being offered as an expert.··She's clearly not an
11· · · ··expert.··She does not know everything there is to
12· · · ··know about the plant.··She doesn't know everything
13· · · ··there is to know about testing.··In fact, she is
14· · · ··contradicted by the industry's preeminent experts
15· · · ··on the whole reason we're here on the potency
16· · · ··level, Your Honor.
17· · · · · · · · ··MS. HUYSER:··May I respond?
18· · · · · · · · ··JUDGE GOLDSTEIN:··Yes.··Go ahead.
20· · · · · · · · ··I would disagree with that classification
21· · · ··of those statements.··She has indicated that she
22· · · ··agrees with these standard method performance,
23· · · ··these SMPRs that have been presented as far as from
24· · · ··the AOAC but that she does believe that their
25· · · ··entire process is incomplete.··That is something

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·1· · · ··that is going to come up.
·2· · · · · · · · ··I don't believe that that is appropriate
·3· · · ··voir dire or to say that she is not qualified
·4· · · ··because she disagrees on -- not even disagrees,
·5· · · ··that she gives a partial statement regarding their
·6· · · ··interpretation of an AOAC certification.
·7· · · · · · · · ··I think that her qualifications allow her
·8· · · ··to explain that further, but I don't believe that
·9· · · ··that's an appropriate topic for a voir dire as to
10· · · ··whether or not she meets the requirements to be
11· · · ··qualified as an expert based on her education,
12· · · ··employment, experience, publications, involvements
13· · · ··in multiple boards, and the fact that she's been
14· · · ··qualified as an expert previously.
15· · · · · · · · ··MR. RUSSELL:··Your Honor, her scientific
16· · · ··conclusions have been conclusively proven false.
17· · · ··It's the whole reason she's set to testify.
18· · · · · · · · ··If she wants to testify to those facts,
19· · · ··that's fine.··She's clearly not an expert.
20· · · · · · · · ··MS. HUYSER:··We haven't heard her
21· · · ··scientific conclusions.
22· · · · · · · · ··JUDGE GOLDSTEIN:··The Tribunal -- I've
23· · · ··heard enough.··Thank you.
24· · · · · · · · ··The Tribunal will recognize -- based on
25· · · ··education, experience, and other issues, Rule of

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·1· · · ··Evidence MRA 702 factors, the Tribunal will
·2· · · ··recognize this witness in the field of plant
·3· · · ··pathology.··Any differences of opinions between her
·4· · · ··and the AOAC -- is that what they're called? --
·5· · · ··goes to her -- goes to the weight to be given her
·7· · · · · · · · ··MR. RUSSELL:··Thank you, Your Honor.
·8· · · · · · · · ··MS. HUYSER:··Thank you, Your Honor.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··Is that what it's
10· · · ··called?··AOAC?··AOAC?··Is that correct?
11· · · · · · · · ··MS. HUYSER:··Yes.
13· · · · · · · · ··Go ahead, Counsel.
15· · · · · · · ··DIRECT EXAMINATION, CONTINUING
16· ·BY MS. HUYSER:
17· ·Q· ··This is going to -- we're going to kind of start
18· · · ··off giving some background information at this
19· · · ··point for the ALJ, okay, Ms. Patterson?
20· ·A· ··Yes, ma'am.
21· ·Q· ··Thank you.··Are you familiar with the business
22· · · ··entitled Viridis North as well as Viridis in
23· · · ··general?
24· ·A· ··I am.
25· ·Q· ··And how are you aware of them?

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·1· ·A· ··I am aware of them because they are licensed with
·2· · · ··the CRA as licensed testing laboratories.
·3· ·Q· ··Are they two separate laboratories?
·4· ·A· ··They are two separate physical locations that have
·5· · · ··the same ownership, SOPs, which are standard
·6· · · ··operating procedures, and operations.
·7· ·Q· ··Do they have two separate staff, or do the staff,
·8· · · ··to your knowledge, do communicate with either one
·9· · · ··interchangeably?··How does that communication work?
10· ·A· ··Typically when I have communications with them I
11· · · ··communicate with their management staff which would
12· · · ··be Greg Michaud, Michele Glinn, Todd Welch, as well
13· · · ··as Michael LaFramboise.··Those staff go back and
14· · · ··forth interchangeably.··A number of other staff,
15· · · ··from what I can tell, particularly management
16· · · ··staff, will go back and forth, though I'm not sure
17· · · ··about lower-level staff like technicians.··I think
18· · · ··it's kind of on an as-needed basis as far as I'm
19· · · ··aware.
20· ·Q· ··Throughout your job performance have you had an
21· · · ··opportunity to review different standard operating
22· · · ··procedures?
23· ·A· ··Yes, I have, many.
24· ·Q· ··And if we talk generalizations, do they differ
25· · · ··between each lab?

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·1· ·A· ··No.
·2· ·Q· ··So are they completely identical?··Explain to me
·3· · · ··kind of that role and how that works.
·4· ·A· ··Yes, they are what we would call, essentially,
·5· · · ··copy-paste.··And early on -- so Viridis Lansing
·6· · · ··location was licensed first, and then Viridis North
·7· · · ··Laboratories was licensed second.··And early on,
·8· · · ··actually I believe it was Todd Welch who primarily
·9· · · ··oversees the Viridis North location, had asked me
10· · · ··if it was okay if they just copy-pasted the methods
11· · · ··that they used at Lansing Viridis for Viridis
12· · · ··North.
13· · · · · · · · ··I responded that they could use the same
14· · · ··SOPS but we would need them to submit data
15· · · ··essentially showing that they were performing the
16· · · ··standard operating procedures the same in both
17· · · ··locations.
18· · · · · · · · ··So they have separate method approvals,
19· · · ··they have separate validation reviews, but the
20· · · ··standard operating procedures themselves and the
21· · · ··operations themselves are identical.
22· ·Q· ··And do they pertain -- do you have to when you're a
23· · · ··safety compliance facility or what we're going to
24· · · ··refer to as a lab, do you have to have a medical
25· · · ··license, an adult use license, for a lab that's

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·1· · · ··qualified to test both?··How does that work?
·2· ·A· ··It depends on what the lab seeks.··Typically we
·3· · · ··have folks in this industry will choose to get both
·4· · · ··a medical license as well as an adult use license
·5· · · ··for purposes of their operation, but there's
·6· · · ··nothing that would require them to have one or the
·7· · · ··other.··They could choose whichever they wanted or
·8· · · ··both if they so desired.
·9· ·Q· ··What is the status of Viridis, both we're going to
10· · · ··say collective Viridis's licenses?
11· ·A· ··They both have a medical license and they both hold
12· · · ··a recreational license.
13· ·Q· ··What is -- you've used the word standard operating
14· · · ··procedure.··What is that?
15· ·A· ··A standard operating procedure can be used in a lot
16· · · ··of different places, really any work space, but
17· · · ··they're particularly important in laboratory
18· · · ··spaces.
19· · · · · · · · ··So standard operating procedure, as the
20· · · ··name implies, is a document that shows folks how to
21· · · ··operate in a standard way to ensure that things
22· · · ··happen the same way all the time in that space.
23· · · ··And, you know, while that is important for
24· · · ··operations at different businesses it's
25· · · ··particularly important for a laboratory because we

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·1· · · ··want to make sure collectively, we as scientists
·2· · · ··want to make sure that a laboratory is doing
·3· · · ··something the same way all the time every time.
·4· ·Q· ··Why?
·5· ·A· ··Because that is the basis of science.··Essentially
·6· · · ··we want to make sure that there is no bias.··That
·7· · · ··there's nothing that's going to happen and that
·8· · · ··we're not going to introduce any sources of error
·9· · · ··that don't already exist in the realm of existence.
10· · · ··We want to make sure that each technician, each
11· · · ··person who touches that method, is going to do it
12· · · ··exactly the same as the last person who touched
13· · · ··that method.
14· · · · · · · · ··And that's important because folks are
15· · · ··relying on these results for something.··In this
16· · · ··case they're relying on those results for accuracy
17· · · ··in cannabis testing.··And that's incredibly
18· · · ··important because, especially here in the cannabis
19· · · ··regulatory space, these labs are responsible for
20· · · ··what gets out to consumers.··They are essentially
21· · · ··the gatekeepers of this industry.··So the results
22· · · ··that they report have to be fair, accurate,
23· · · ··precise, reliable all of the time.··Otherwise,
24· · · ··whatever is going out to consumers we have no
25· · · ··certainty on.··And if consumers don't have

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·1· · · ··certainty, then they're not doing their jobs in
·2· · · ··protecting the consumer population and informing
·3· · · ··them properly of what it is they're purchasing or
·4· · · ··using.
·5· ·Q· ··When you talk about SOPs, how does one acquire an
·6· · · ··SOP or develop an SOP?
·7· ·A· ··So a standard operating procedure can come about in
·8· · · ··a lot of ways.··In the laboratory space, you know,
·9· · · ··it may be something that they, honestly, search the
10· · · ··internet for.··It depends on what kind of SOP
11· · · ··you're looking for.··So if you're looking for
12· · · ··something like a quality assurance manual,
13· · · ··something that ensures day-to-day quality and
14· · · ··oversight, that may be something that they refer to
15· · · ··peer-reviewed scientific literature.··They may
16· · · ··refer to a consultant and see if a consultant can
17· · · ··assist them in forming that standard operating
18· · · ··procedure.··They may come up with that on their own
19· · · ··and sort of guess and test that with their
20· · · ··accrediting body or their regulatory body.
21· · · · · · · · ··Now, as it comes to actual laboratory
22· · · ··methods, those standard operating procedures are
23· · · ··something that should be, according to our rules,
24· · · ··based on peer-reviewed literature.··And that's
25· · · ··something that folks can find through doing deep

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·1· · · ··dives on the internet or our friend Google Scholar
·2· · · ··at the library.··And they would review those
·3· · · ··methods, find a method of reference, and then take
·4· · · ··that back to their laboratory space and either
·5· · · ··perform a verification or a validation, depending
·6· · · ··on what needed to be done, to ensure that that
·7· · · ··method is operating the same in their lab as it did
·8· · · ··in the laboratory where it was first published.
·9· ·Q· ··Okay.··We threw out a lot of scientific words that
10· · · ··I'm going to circle back around to.
11· ·A· ··Sure.
12· ·Q· ··So you have mentioned -- you said laboratory
13· · · ··methods.··What are laboratory methods, and how do
14· · · ··they differ from other types of standard operating
15· · · ··methods?··Or procedures.··Excuse me.
16· ·A· ··So laboratory methods are the methods that really
17· · · ··oversee the day-to-day of testing.··The things that
18· · · ··the laboratorians, the technicians, are going to
19· · · ··use in their daily work.
20· · · · · · · · ··For us here in, you know, the cannabis
21· · · ··regulatory space those methods are going to be
22· · · ··things that address the requirements and rule for
23· · · ··testing.··So, you know, cannabis potency testing.
24· · · ··Cannabis foreign matter testing.··Cannabis
25· · · ··microbial testing.··Chemical residues.··Residual

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·1· · · ··solvents.··And it essentially covers the entirety
·2· · · ··of the method from beginning to end.··So that
·3· · · ··includes sample procurement.··Sample preparation.
·4· · · ··Homogenization.··How the sample is actually
·5· · · ··prepared so that it can be analyzed on its
·6· · · ··instrument.··Instrument specifications.··How the
·7· · · ··data is reported.··How the data is read.··How the
·8· · · ··data is then reported out to the customer as well
·9· · · ··as, like I said, those quality oversight and
10· · · ··quality management pieces for each of those
11· · · ··separate methods.
12· ·Q· ··So when a lab decides or when you have a business
13· · · ··that's deciding they're going to become a licensed
14· · · ··laboratory, all of these things have to be in
15· · · ··place?
16· ·A· ··They don't have to be in place right as they want
17· · · ··to be a licensed.··Ultimately we allow our
18· · · ··licensees to essentially do as they will.
19· · · · · · · · ··Some licensees onboard and they have no
20· · · ··methods prepared, and that's because they want to
21· · · ··work with an LSS or a regulatory body to ensure
22· · · ··that they're on the right path, so to speak, to
23· · · ··getting their methods approved.
24· · · · · · · · ··Some laboratories come on and they have
25· · · ··all of their methods prepared, verified.··They're

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·1· · · ··ready to submit on their first day.
·2· · · · · · · · ··So it's not necessarily a cornerstone to
·3· · · ··licensure, but it is something that they need to
·4· · · ··have in place in order to be a laboratory that
·5· · · ··tests actively for the industry and receives some
·6· · · ··sort of payment back for doing that testing.
·7· ·Q· ··And how was Viridis -- were you involved either
·8· · · ··with the establishment or the setting up of either
·9· · · ··of the Viridis Labs as far as with the CRA's piece?
10· ·A· ··Yes, I was.··Viridis Lansing, I think when they
11· · · ··first became licensed I was actually out on
12· · · ··maternity leave, but I was still involved with
13· · · ··communicating with them.··And then when I returned
14· · · ··back from my maternity leave I took them over as
15· · · ··one of my primary laboratories that I provided
16· · · ··oversight to.
17· · · · · · · · ··And then with Viridis North I started
18· · · ··their onboarding is what we call it, their
19· · · ··onboarding process, saw some of their initial SOPs
20· · · ··come in and get approved, and then I was also
21· · · ··transitioning to my managerial role at that time.
22· · · ··So as I was transitioning into that role I was sort
23· · · ··of handing them off to my new LSS Noah and still
24· · · ··kind of assisting in that process when this
25· · · ··transition was occurring.

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·1· ·Q· ··Were you involved in the approval of the initial
·2· · · ··standard operating procedures?
·3· ·A· ··Yes, I was.
·4· ·Q· ··And tell me a little bit about what that process
·5· · · ··is.
·6· ·A· ··So when a laboratory first comes online and they
·7· · · ··want to submit their standard operating procedures
·8· · · ··or their methods what we have them do is we have
·9· · · ··them submit their standard operating procedure,
10· · · ··which is essentially the written recipe for how
11· · · ··they're going to do their method.··Any associated
12· · · ··quality control documents, any logs or things that
13· · · ··they're going to keep for, you know, laboratory
14· · · ··tracking, data that may be related to their
15· · · ··verification or their validation essentially
16· · · ··stating, you know, we know that our method works in
17· · · ··our lab because of this and here's the data, here
18· · · ··it is in a package, as well as proficiency tests
19· · · ··that demonstrate their ability to operate that
20· · · ··method as well.
21· ·Q· ··Okay.··Is Viridis familiar with the process for
22· · · ··establishing a standard operating procedure?
23· ·A· ··Absolutely.
24· ·Q· ··About how many, if you could throw out an
25· · · ··approximation, did you work with them on

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·1· · · ··establishing?
·2· ·A· ··If I had to estimate I would say at least 20 in
·3· · · ··various iterations throughout the course of time.
·4· ·Q· ··Did you follow the same process every -- every way?
·5· ·A· ··I followed it on most of the ways.··There were a
·6· · · ··couple, in particular two, which I think we're --
·7· · · ··are here in question today that came as standard
·8· · · ··operating procedures to us but they did not follow
·9· · · ··what we would require for the submission of a
10· · · ··standard operating procedure.··And so that in
11· · · ··particular was denied.··And that deviated for
12· · · ··reasons that I believe that we'll get into.
13· ·Q· ··Okay.··What is the general process to have an SOP?
14· · · ··Are there particular forms?··Is it done in writing?
15· · · ··Over email?··How does it work?
16· ·A· ··So typically when a laboratory wants to submit a
17· · · ··method and, you know, essentially a validation or
18· · · ··verification for review they will do that via
19· · · ··email.··They'll send us an email to either their
20· · · ··assigned LSS or preferably the CRA safety
21· · · ··compliance facility in box, and they will submit
22· · · ··all of those aforementioned documents, their SOPs,
23· · · ··any associated logs, the data, the proficiency
24· · · ··test, and let us know, hey, this is a method.··We
25· · · ··want you to review it.··Here's all the stuff that

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·1· · · ··you need.
·2· · · · · · · · ··So once we get that information what
·3· · · ··we'll do is if it's all there we review it.··And
·4· · · ··from that there are two specific documents that we
·5· · · ··use to track our reviews.··So we have a method
·6· · · ··approval summary, and that is essentially a living
·7· · · ··document that provides a whole case history of the
·8· · · ··method, how it's changed over time, what may be
·9· · · ··missing, what is present, the date that it was
10· · · ··approved.··And that's something that we keep to
11· · · ··keep track of the method and to let the lab know --
12· · · ··it kind of travels back and forth between us and
13· · · ··the lab -- but it lets them know where they're at
14· · · ··in that approval process.
15· · · · · · · · ··Additionally we have something called the
16· · · ··method validation review or the Method Approval
17· · · ··Report, and that's something that goes over a
18· · · ··particular method, a particular validation or
19· · · ··verification specifically and provides our comments
20· · · ··and our feedback.··That form also notes whether the
21· · · ··method itself has been approved or denied.··And
22· · · ··that also travels back to the laboratory so that
23· · · ··they know the status of each method that they
24· · · ··supplied to us.
25· ·Q· ··Do you have a procedure in place that allows for an

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·1· · · ··approval without use of the Method Approval Report?
·2· ·A· ··We do not.
·3· ·Q· ··Have you ever approved a method without using an
·4· · · ··approval -- Method Approval Report?
·5· ·A· ··Absolutely not.
·6· ·Q· ··So you've used a couple other words in there that
·7· · · ··are called -- that you've said, validation and
·8· · · ··verification.··Can you tell me what those --
·9· · · ··what -- we'll start with a verification.··What is
10· · · ··that?
11· ·A· ··So in basic terms a verification is something that
12· · · ··essentially verifies that the method is running as
13· · · ··its supposed to be.··So, as I mentioned before,
14· · · ··typically that's when you take a method of
15· · · ··reference.··Something that someone else has
16· · · ··published, studied, peer reviewed.··You take that
17· · · ··kind of out of its box, take that box to your
18· · · ··laboratory and say I'm showing you with this data
19· · · ··that our laboratory performs this method in the
20· · · ··same way that it did in this other laboratory and
21· · · ··as it should in every other laboratory.
22· · · · · · · · ··That's a very -- it's essentially a
23· · · ··low-level overview of the method.··It's not super
24· · · ··intensive.··We have some specific requirements for
25· · · ··it, but, like I said, it's pretty short.··It's

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·1· · · ··pretty simple.
·2· · · · · · · · ··Now, a method validation is more of a
·3· · · ··doozy.··So those are something that we would
·4· · · ··require if a method as what we call kind of
·5· · · ··homegrown or a lab-started method.··And method
·6· · · ··validations are truly a bear.··It's something that
·7· · · ··can take years to actually validate from beginning
·8· · · ··to end.··Like I said that would include sample
·9· · · ··preparation, homogenization, prepping it in its
10· · · ··analytical space, running it through the instrument
11· · · ··reporting results, etc., etc.
12· · · · · · · · ··And that's essentially a process that
13· · · ··starts with a question.··And it's like any other
14· · · ··research study.··You're going to say, you know, I
15· · · ··have this question.··I want to start this method.
16· · · ··I want to create this new method.··But you really
17· · · ··have to scientifically attack it from all angles,
18· · · ··and you come up with a lot of data that essentially
19· · · ··approves scientifically beyond a doubt that your
20· · · ··method is accurate and precise and true and that
21· · · ··you're eliminating all potential sources of bias.
22· ·Q· ··This validation is not something just used in the
23· · · ··marijuana world; correct?
24· ·A· ··Correct.
25· ·Q· ··Is it used for all types of scientific process

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·1· · · ··or --
·2· ·A· ··Yes, it is.
·3· ·Q· ··So this isn't something that you've created just in
·4· · · ··the last few years?
·5· ·A· ··No.
·6· ·Q· ··Are there certain accrediting bodies or things
·7· · · ··other than just the CRA that would approve a
·8· · · ··validation?
·9· ·A· ··Yes.··So the AOAC would approve of a validation in
10· · · ··varying degrees, essentially.··There are other
11· · · ··bodies, you know, research universities, other
12· · · ··research avenues, I would say something like, you
13· · · ··know, the National Institute of Health that could
14· · · ··potentially approve something like that.··But for
15· · · ··obvious reasons in the federal status of cannabis
16· · · ··those folks don't tend to get too involved here.
17· ·Q· ··What is the AOAC?··We've heard that referenced a
18· · · ··couple of times.
19· ·A· ··So the AOAC is a body essentially that reviews
20· · · ··methods and typically, historically actually,
21· · · ··they're chemical methods that come from the food
22· · · ··testing space.
23· · · · · · · · ··And recently and, you know, since we have
24· · · ··really seen the uptick in the legalization of
25· · · ··cannabis they've started to oversee the validation

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·1· · · ··and verification of various methods in cannabis.
·2· · · ··They're kind of dipping their toe into the space
·3· · · ··and working to develop official methods of
·4· · · ··analysis, you know, other what I would term as like
·5· · · ··low-level methods of various types of analysis.
·6· · · ··They provide standard method performance
·7· · · ··requirements.··And this is all the work of a lot of
·8· · · ··people working together to determine what is
·9· · · ··appropriate and true in cannabis testing.
10· ·Q· ··You're saying that -- you used standard method
11· · · ··performance requirements.··What's that?
12· ·A· ··So the standard method performance requirements are
13· · · ··essentially the baseline of what a laboratory needs
14· · · ··to hit to ensure that a method is running the way
15· · · ··that it needs to be running.··And these are the
16· · · ··things that we check in the Agency as part of a
17· · · ··verification.
18· · · · · · · · ··And it says, as I mentioned before,
19· · · ··essentially this method runs the way that it's
20· · · ··supposed to in our lab and this is how we know it
21· · · ··meets the standard method performance requirements.
22· · · ··It's what we would consider a baseline.
23· ·Q· ··Does it meet all of the requirements that the CRA
24· · · ··would need for a new method to be used?
25· ·A· ··No.

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·1· ·Q· ··And why not?
·2· ·A· ··As I said it's the baseline.··It's essentially a
·3· · · ··verification.··It doesn't necessarily fulfill the
·4· · · ··requirements of a validation.
·5· · · · · · · · ··And that's because a validation really
·6· · · ··has to cover everything in the method from its
·7· · · ··inception, sample procurement, sample
·8· · · ··homogenization, sample preparation, all of the
·9· · · ··analytical steps for extraction, instrument
10· · · ··running, data, everything from beginning to end.
11· · · ··So it's really -- it's -- it's more of a snapshot
12· · · ··than the full book.
13· ·Q· ··And if you're in the process of working with AOAC
14· · · ··or if a licensee is in the process of a validation
15· · · ··should they be using the study, or using the method
16· · · ··that they're having studied?
17· ·A· ··If it has not been validated and it has not been
18· · · ··approved by the Agency, which if it were not
19· · · ··validated it would not be approved by the Agency,
20· · · ··they should absolutely not be using that method in
21· · · ··practice in the laboratories and using it to report
22· · · ··results because ultimately there may be bias there.
23· · · ··And that's a huge concern in the scientific
24· · · ··community and a concern for consumers.
25· ·Q· ··Is there a time let's say that a method is or may

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·1· · · ··be validated but the CRA has not approved it yet?
·2· · · ··Does that ever happen?
·3· ·A· ··So far in our history we have not seen a method
·4· · · ··that has been approved and validated that we have
·5· · · ··not approved.
·6· ·Q· ··The CRA will review any full validation that's been
·7· · · ··provided with all of the documents for the method
·8· · · ··review; correct?
·9· ·A· ··Absolutely.
10· ·Q· ··All right.··So I kind of went off a little bit on
11· · · ··that so we'll backtrack up here to -- Viridis you
12· · · ··said was keeping their -- their SOPs or standard
13· · · ··operating procedures something that had been
14· · · ··approved in both locations; correct?
16· ·Q· ··And do you recall when -- we'll go back to when,
17· · · ··like, their -- they had a packet or a full amount
18· · · ··or -- of standard operating procedures, or did they
19· · · ··kind of trickle in where they could start testing,
20· · · ··or did they wait for -- to have, you know, potency,
21· · · ··foreign matter, everything before they started
22· · · ··testing?
23· ·A· ··They trickled in, actually, for a period of time.
24· · · ··And early on there was -- let me back up a little
25· · · ··bit and explain this.

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·1· · · · · · · · ··So the process, as I said, is they can
·2· · · ··either come in all together or they can sort of
·3· · · ··trickle in.··And they can do this in different
·4· · · ··ways.··So they may send in a couple different test
·5· · · ··types for, like I said, you know, potency,
·6· · · ··microbial analysis, pesticides, chemical residues.
·7· · · ··But they can also do that in different matrices.
·8· · · ··And matrices are the usable form of cannabis that
·9· · · ··they're testing.··So there's cannabis flower,
10· · · ··cannabis concentrate, and generally
11· · · ··cannabis-infused products.
12· · · · · · · · ··And so when they first started submitting
13· · · ··their method I believe that they were actually just
14· · · ··submitting the method sort of, you know, couple by
15· · · ··couple.··You know, a few here and there.··But they
16· · · ··started with the cannabis flower matrix, and then
17· · · ··they moved on to include some of the other matrices
18· · · ··as they got those initial approvals taken care of.
19· · · ··And that's pretty typical for laboratories just so
20· · · ··they can start testing in that space, and it gives
21· · · ··them a stream of revenue, essentially.
22· ·Q· ··Were you working pretty closely with both Viridis
23· · · ··North and Viridis Lansing throughout this initial
24· · · ··process?
25· ·A· ··Yes, I was.

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·1· ·Q· ··How would you categorize your working relationship
·2· · · ··with them?
·3· ·A· ··Initially I felt our working relationship was
·4· · · ··pretty good.··I feel like I'm pretty friendly to
·5· · · ··licensees.··I like to help our labs get on board
·6· · · ··because I'm so passionate about what they do here
·7· · · ··for our industry, and I thought that we had a
·8· · · ··really great relationship.
·9· · · · · · · · ··But then they started to get a bit
10· · · ··adversarial with me, and it was kind of based, I
11· · · ··felt, on whether or not I was approving their
12· · · ··methods or if I was denying them or providing them
13· · · ··sort of feedback that they may not have wanted to
14· · · ··hear.
15· · · · · · · · ··And I didn't think too much of it early
16· · · ··on but there started to be some instances where I
17· · · ··would provide feedback, I would request a little
18· · · ··bit more information, and, like I said, I felt like
19· · · ··they were adversarial, and they may have been, you
20· · · ··know, withholding some things from me, which was a
21· · · ··little disappointing, of course.
22· ·Q· ··You described a little bit about different types of
23· · · ··-- you said flower, a concentrate, infused
24· · · ··products.
25· · · · · · · · ··How does testing work with each one of

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·1· · · ··those?··Not -- sorry, not the global picture.··That
·2· · · ··was a really poor question.··But do you ask
·3· · · ··questions -- like do you have them test each one of
·4· · · ··those individually?··Do we test at different
·5· · · ··stages?··How do we ensure that as things grow and
·6· · · ··become a final product for the consumer that it's
·7· · · ··safe?
·8· ·A· ··So really they have to do these verifications or,
·9· · · ··as necessary, validations based on each matrix type
10· · · ··because the matrices are so different.
11· · · · · · · · ··Cannabis flower is, as -- as the name
12· · · ··entails, is a flower.··It's a leafy material.··It's
13· · · ··got trichomes on it.··But when you get into things
14· · · ··like cannabis concentrate, that's actually all the
15· · · ··trichomes removed and collected together in this
16· · · ··incredibly like thick, resinous, viscous substance.
17· · · ··So you might imagine, you know, testing two
18· · · ··separate things like that is a very different ball
19· · · ··game.
20· · · · · · · · ··And then when you look at things like all
21· · · ··of the infused products that are on the market you
22· · · ··see things like lotions, you know, gummies, gummy
23· · · ··bears -- although not bears in our market because
24· · · ··that's not permitted -- suckers, candy, various
25· · · ··types of beverages, cookies.

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·1· · · · · · · · ··And so each time you have a new form of
·2· · · ··cannabis that you're testing it provides additional
·3· · · ··challenges.··You know, when you start looking at
·4· · · ··those cannabis-infused products you are starting to
·5· · · ··talk about the addition of sugars and fats, like
·6· · · ··butter and flour and things like that.
·7· · · · · · · · ··And so folks have to try really hard to
·8· · · ··basically keep the noise out from what it is that
·9· · · ··they're working with and actually be able to test
10· · · ··the root of what it is that they're looking at,
11· · · ··particularly when it comes to things like potency.
12· ·Q· ··And let's talk a little bit about potency and
13· · · ··flower.
14· · · · · · · · ··What exactly does a marijuana flower --
15· · · ··you talked about it being leafy with trichomes, but
16· · · ··what's the makeup of a marijuana flower?
17· ·A· ··So a marijuana flower, it doesn't look like any
18· · · ··flower that you're going to get on Mother's Day,
19· · · ··for instance, but it is overall a green plant, and
20· · · ··it has a stem, as all plants do, it has its leaves
21· · · ··off to the sides, and then it has these green,
22· · · ··honestly leaf-looking flowers.··And then on those
23· · · ··flowers what you have are various types of
24· · · ··trichomes.··And trichomes are glandular hairs, so
25· · · ··they're these little hairs that come up out of the

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·1· · · ··plant.··And then the glandular hairs grow these
·2· · · ··big, or small in some cases, water tower looking
·3· · · ··bulbous resin reservoirs on top of them.
·4· · · · · · · · ··And so that's where the THC, you know,
·5· · · ··the CBD, the various cannabinoids and terpenes are
·6· · · ··actually held within these very delicate hair-like
·7· · · ··structures.··And those are used to actually protect
·8· · · ··the plant from pathogens and protect it from
·9· · · ··sunlight and other environmental factors.
10· ·Q· ··And when you're testing the potency of flower what
11· · · ··are you testing?
12· ·A· ··When you're testing the potency of flower really
13· · · ··what you're testing is whatever's going to the
14· · · ··consumer.
15· · · · · · · · ··So typically our cultivators here in
16· · · ··Michigan, at least from what I've seen, go ahead
17· · · ··and they harvest the whole plant itself, and that
18· · · ··includes the stem, the stalks the leaves.··But what
19· · · ··they do is they shuck those flowers off, which keep
20· · · ··in mind the flower is the flower itself with the
21· · · ··trichome heads, and those are what go for testing.
22· · · · · · · · ··And so when an end consumer is going to
23· · · ··use that flower they're going to take the flower
24· · · ··itself, that leafy green part, or leafy-looking
25· · · ··green part, as well as the trichomes, and they're

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·1· · · ··going to grind it all up and use that to,
·2· · · ··essentially, combust it for inhalation.
·3· · · · · · · · ··And so when you're -- when you're testing
·4· · · ··that for potency you're testing the leafy-looking
·5· · · ··green part as well as the trichomes themselves all
·6· · · ··together in a homogenous fashion.··And that's going
·7· · · ··to give you what the consumer is going to actually
·8· · · ··be using in practice when they're, you know, at
·9· · · ··their home, their kitchen table or whatever.
10· ·Q· ··Throughout your work with Viridis was there an
11· · · ··early on section where you were concerned with
12· · · ··potency being too low?
13· ·A· ··Yes, there was.··It was interesting early on
14· · · ··because -- so we've always monitored data at the
15· · · ··CRA and Metrc data coming through.··And so we
16· · · ··noticed for a period of time that Viridis was
17· · · ··actually reporting samples that were quite low.··I
18· · · ··want to say, based on recollection, about 5 or 8
19· · · ··percent potency, which is unusual.··You know,
20· · · ··typically cultivators are looking at potency around
21· · · ··15 percent at least.··So that would be what we
22· · · ··would be looking at.
23· · · · · · · · ··So I noticed that they were putting very
24· · · ··low.··And I reached out to them to actually ask why
25· · · ··and try and help them figure out why the potency

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·1· · · ··was so low because it was very unusual.··And based
·2· · · ··on my experience in cannabis testing that happening
·3· · · ··so frequently, I assumed that there must be
·4· · · ··something going on maybe that they were missing in
·5· · · ··one of their preparation steps.
·6· ·Q· ··And were you able to get to the bottom of that?
·7· ·A· ··Yes, I was.
·8· · · · · · · · ··So I believe that I talked to Greg
·9· · · ··Michaud as well as Michele Glinn and found out that
10· · · ··they were getting a lot of stem tissue in there.
11· · · ··They were homogenizing excess stem tissue as well
12· · · ··as excess leaf tissue.··And so I let them know,
13· · · ··particularly with the stem tissue, that that was
14· · · ··contributing essentially a really large weight of
15· · · ··ground plant material that wasn't going to have a
16· · · ··lot of trichomes on it.
17· · · · · · · · ··And ultimately when a consumer gets a
18· · · ··cannabis flower they're not going to smoke the
19· · · ··stems.··They're not going to grind up the stems.
20· · · ··There's a lot of popular media that says no stems,
21· · · ··no sticks, no seeds, because you don't want that
22· · · ··stuff.··And that's not what a consumer is actually
23· · · ··going to use.··They're going to pick that stuff
24· · · ··off, they're going to cast it away, and then
25· · · ··they're going to keep that flower just with the

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·1· · · ··trichomes.
·2· · · · · · · · ··And so I let them know, you know, hey,
·3· · · ··this is providing probably a proportionately large
·4· · · ··amount of plant material that's not going to have
·5· · · ··trichomes, and it's bringing your total potency
·6· · · ··down.
·7· ·Q· ··And did they correct that process?
·8· ·A· ··They did.
·9· ·Q· ··Was that something that would have required a
10· · · ··different method or a change in their method to fix
11· · · ··this issue?
12· ·A· ··No, not in particular.
13· · · · · · · · ··So when -- essentially, we don't want our
14· · · ··cannabis flower going to consumers having large
15· · · ··sticks or stems or leaves or anything like that.
16· · · ··But that's something that will be picked up on the
17· · · ··foreign matter method.··If a cultivator submits a
18· · · ··plant or, you know, a flower that has all that
19· · · ··stuff on it, the laboratory's going to report that
20· · · ··out and say there's tons of stems, there's tons of
21· · · ··seeds, there's tons of leaves on here.··And that
22· · · ··would fail the foreign matter if it met the
23· · · ··appropriate threshold.
24· · · · · · · · ··But when it comes to potency testing they
25· · · ··can go ahead and remove those unreasonably large

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·1· · · ··stems and leaves in order to ensure that they're
·2· · · ··testing what is representative of what that
·3· · · ··consumer's actually going to get.
·4· ·Q· ··You have mentioned that typical yield or typical
·5· · · ··potency is right around 15 percent?
·6· ·A· ··On average, but potency can reach up to, based on
·7· · · ··current literature, about 27 percent.··And I think
·8· · · ··the last literature that I saw, and I believe that
·9· · · ··came out in 2019, said that about 1 percent of all
10· · · ··samples can exceed that 27 percent.··And that's
11· · · ··just based on the biochemical genetic limitations
12· · · ··of the plant, the environmental conditions at this
13· · · ··point in time.
14· ·Q· ··And when you say typical around 15 percent --
15· · · ··sorry, I'm going to circle back to that too -- but
16· · · ··where are you getting -- is that typical in
17· · · ··Michigan?··Is that typical based on studies?··Based
18· · · ··on what is reported to Metrc?··How are we getting
19· · · ··that typical?
20· ·A· ··So the 15 percent that I was referring to as being
21· · · ··typical was here in Michigan, and that was looking
22· · · ··at data early on.··Granted, I want to say there
23· · · ··were only six laboratories licensed around that
24· · · ··time.··And that was also prior to all our adult use
25· · · ··markets coming online as well.

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·1· ·Q· ··Do you have any policies --
·2· · · · · · · · ··MR. RUSSELL:··I'm going to object to a
·3· · · ··lack of foundation as to the percentage in the
·4· · · ··state of Michigan.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Response, Counsel?
·6· · · · · · · · ··MS. HUYSER:··I believe she stated it's
·7· · · ··based on -- their job is to oversee labs, and it
·8· · · ··was based on the six percent -- or six labs that
·9· · · ··are in Michigan based on data.
10· · · · · · · · ··JUDGE GOLDSTEIN:··I'll allow the
11· · · ··question.··Objection overruled.
12· ·Q· ··(MS. HUYSER) Do you have any procedures in place or
13· · · ··any policies in place regarding potency that is
14· · · ··either considered too low or too high or anything
15· · · ··along that with the CRA?
16· ·A· ··Yes, I do.
17· ·Q· ··Tell me about that, please.
18· ·A· ··So we have always, as the Agency at least since I
19· · · ··started in March of 2019, we've always had a policy
20· · · ··of reviewing Metrc data as it came to us.··And so
21· · · ··every time, every day, every week Metrc data was
22· · · ··reported.··It was sent to the LSSs for review.
23· · · · · · · · ··Very early on and even still we reviewed
24· · · ··it for high potency, low potency, data anomalies.
25· · · ··Sometimes labs, they have these API integrators,

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·1· · · ··which I don't fully understand, but essentially
·2· · · ··sometimes it can happen that the data gets messed
·3· · · ··up, that it gets pushed into Metrc wrong, and it
·4· · · ··reports all zeros for a day.
·5· · · · · · · · ··So those are the kinds of things that we
·6· · · ··look for.··Just weird trends, weird data anomalies.
·7· · · · · · · · ··Like I said, that started in 2019, March
·8· · · ··when I was here, I was tasked with doing that.
·9· · · · · · · · ··And then in I believe it was May of 2020
10· · · ··we officially wrote a standard operating procedure
11· · · ··for ourselves to formalize the review of those data
12· · · ··anomalies, and we included high and low potency.
13· · · ··We included, you know, like I said, the weird
14· · · ··trends.··If somebody's reporting all zeros or all
15· · · ··100s or something strange.··We report -- or record
16· · · ··repeated failures for things like pesticides
17· · · ··because it's just statistically unusual to see
18· · · ··those things in the data.
19· · · · · · · · ··So what we'll do is reach out to the lab
20· · · ··and ask them to verify that their results are --
21· · · ··are as they were reported in Metrc and that they're
22· · · ··correct.
23· ·Q· ··So how does this relate to a high potency report?
24· ·A· ··So this is a part of the high potency reports.··And
25· · · ··so that method or standard operating procedure for

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·1· · · ··us has become more refined over the time as the
·2· · · ··current literature became available and became
·3· · · ··available to us in particular.··And so it's
·4· · · ··something that we look at to say -- essentially,
·5· · · ··you know, notice if somebody is reporting or a
·6· · · ··laboratory is reporting very low potency or a very
·7· · · ··high potency because statistically it's unusual to
·8· · · ··see those things.··And it's our job as regulators
·9· · · ··to make sure that we're noticing those strange
10· · · ··trends to ensure that consumers are getting what
11· · · ··they believe that they're getting and what's on the
12· · · ··label for what they're getting and to oversee the
13· · · ··laboratories.
14· ·Q· ··So what's your high potency number?
15· ·A· ··So we actually bumped up our high potency number.
16· · · ··In the scientific data it's 27 percent.··But, you
17· · · ··know, cultivators are working to improve their
18· · · ··strains, to improve environmental conditions in
19· · · ··genetics.··So we like to give that another 2
20· · · ··percent.
21· · · · · · · · ··So our potency is set at 29 percent right
22· · · ··now.··And any potency that exceeds that is
23· · · ··something that we will follow up with the
24· · · ··laboratory for and have them verify are they
25· · · ··following their procedure.··Are they, you know,

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·1· · · ··ensuring that there's not any variation between
·2· · · ··their technicians that are there on different days
·3· · · ··for example.··And so we have them reanalyze those
·4· · · ··samples to ensure that what they're reporting is
·5· · · ··accurate and true.
·6· ·Q· ··Did Viridis hit a point where they had to start
·7· · · ··falling under this category of retesting for high
·8· · · ··potency?
·9· ·A· ··Yes, they did.
10· ·Q· ··And was that Viridis Lansing?··Viridis North?
11· · · ··Both?
12· ·A· ··Both locations.
13· ·Q· ··And do you recall about when you started seeing the
14· · · ··high potency results?
15· ·A· ··It was early November in 2020.
16· · · · · · · · ··MR. RUSSELL:··I'm going to object again
17· · · ··to lack of foundation.··She's testifying to high
18· · · ··potency that's never been -- there's never been
19· · · ··laid a foundation how that -- this number was
20· · · ··arrived at.
21· · · · · · · · ··MS. HUYSER:··She did testify that
22· · · ··science -- she looked at studies, updated that
23· · · ··number, that scientists rely on statistical
24· · · ··measures of 1 percent of all samples based on
25· · · ··articles that were published can hit 27 percent.

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·1· · · ··So the CRA adds a buffer and uses 29 percent.··I do
·2· · · ··believe there's been an accurate foundation that's
·3· · · ··been laid.
·4· · · · · · · · ··MR. RUSSELL:··Okay.··Well, I haven't
·5· · · ··heard what was relied on other than there was
·6· · · ··scientific literature that was relied on.
·7· · · · · · · · ··I think that the witness has to lay a
·8· · · ··foundation to come up with that.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Well,
10· · · ··Counsel, that's the credibility I give her
11· · · ··testimony.··She's already testified as to how the
12· · · ··CRA came up with the 29.
13· · · · · · · · ··I assume you're talking about 29 percent
14· · · ··THC?
15· · · · · · · · ··MS. HUYSER:··Yes.
16· · · · · · · · ··JUDGE GOLDSTEIN:··Is that what we're
17· · · ··talking about here?··Potency, right?
18· · · · · · · · ··MS. HUYSER:··Yes, sir.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So I believe
20· · · ··there's an adequate foundation laid.··Objection
21· · · ··overruled.
22· ·Q· ··(MS. HUYSER) So as we were saying, there was a
23· · · ··point in time, you said right around November, that
24· · · ··both labs started producing high potency numbers?
25· ·A· ··Yes, both labs.

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·1· ·Q· ··And tell me how that came to your attention.
·2· ·A· ··So it actually -- it came about in a couple of
·3· · · ··ways.··So we saw it in the data that we were
·4· · · ··reviewing, of course, and those routine Metrc
·5· · · ··testing data results.··But we also noticed that
·6· · · ··there were some issues with what was happening with
·7· · · ··the method potentially at that point in time.
·8· · · ··Because we had prepared essentially a communication
·9· · · ··that goes out to all laboratories to set up an
10· · · ··interlaboratory comparison event, and we had asked
11· · · ··the lab at that time, you know, what's the minimum
12· · · ··amount of sample that you would need to perform
13· · · ··these tests.··And at that time they told us that
14· · · ··they would use as little as 0.2 grams, which was
15· · · ··unusual because that was a huge deviation from what
16· · · ··their method stated that they would use 1 gram.
17· ·Q· ··I am going to back us up a little bit to kind of
18· · · ··walk through this process just to explain a few
19· · · ··things.
20· · · · · · · · ··Obviously, as the ALJ had pointed, we're
21· · · ··referring to potency, and that -- tell me a little
22· · · ··bit about what potency is.
23· ·A· ··Sure.··So potency, as I said, is the amount of THC
24· · · ··or other cannabinoids that are contained within the
25· · · ··trichomes.··And the trichomes are these hair-like

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·1· · · ··gland structures, they look like little water
·2· · · ··towers, that as the plant grows they get bigger and
·3· · · ··bigger.··They fill up with this resinous substance
·4· · · ··that contains those cannabinoids and terpenes.
·5· · · · · · · · ··And so when we're looking at potency,
·6· · · ··what folks are doing, they're grinding up the
·7· · · ··flower, all of the flower material, as well as all
·8· · · ··those trichomes that are on that flower material.
·9· · · ··And that's exactly what's going to happen when a
10· · · ··consumer uses that product.··They have these
11· · · ··machines -- or not machines.··They're really more
12· · · ··mechanical devices I suppose, they could be
13· · · ··machines, but they use them to actually physically
14· · · ··macerate the material.··And then it drops down into
15· · · ··the bottom.··They take what is left out of there
16· · · ··and that includes that green leafy flower material
17· · · ··as well as the trichomes, and that's what they use
18· · · ··to incinerate and inhale.
19· ·Q· ··So the higher the number, the stronger the
20· · · ··marijuana that the consumer gets?
21· ·A· ··That is correct, yes.
22· ·Q· ··And you mentioned -- you used a phrase
23· · · ··interlaboratory proficiency test or interlaboratory
24· · · ··comparisons?
25· ·A· ··Yes, interlaboratory comparisons.··Interlaboratory

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·1· · · ··proficiency tests.··The terminology is a little bit
·2· · · ··nebulous.
·3· ·Q· ··Tell me what those are.
·4· ·A· ··So those are essentially indicator tests, also
·5· · · ··known as, like, round-robin tests where the Agency,
·6· · · ··because there are no, in our opinion,
·7· · · ··well-qualified proficiency testing programs
·8· · · ··officially we are able to use cannabis that is
·9· · · ··collected as an aggregate sample from our
10· · · ··laboratories.
11· · · · · · · · ··So our laboratories are required to
12· · · ··retain their cannabis waste for 30 days.··And this
13· · · ··is unused flower, you know, concentrate, infused
14· · · ··product material.
15· · · · · · · · ··And so what we do during those
16· · · ··interlaboratory proficiency tests is we have a
17· · · ··laboratory sequester that product for a period of
18· · · ··time.··And then we take, you know, typically a
19· · · ··combination between two, three, five, ten sometimes
20· · · ··samples to create an aggregate sample that what
21· · · ··we'll end up doing is parsing out a small portion
22· · · ··of it to each laboratory so that they can do
23· · · ··testing.
24· · · · · · · · ··And what that helps us identify is if
25· · · ··there's any significant disparities in the methods

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·1· · · ··that folks are using, you know, we'll compare
·2· · · ··different method types if people are all using the
·3· · · ··same method are they detecting similar things.
·4· · · · · · · · ··It's not a great program I will readily
·5· · · ··admit.··It's something that we hope to change here
·6· · · ··by bringing our reference laboratories online
·7· · · ··because it's really more of an indicator test than
·8· · · ··anything.
·9· ·Q· ··So what -- do the entire steps that were -- let's
10· · · ··use -- let's use potency.
11· · · · · · · · ··When you do an interlaboratory comparison
12· · · ··does each lab get to follow their standard
13· · · ··operating procedure from beginning to end or do
14· · · ··they get it halfway through?··How does that work?
15· ·A· ··That's a good -- that's a good catch, Sarah.
16· · · · · · · · ··So really what happens is we, because we
17· · · ··have to combine these samples together as a
18· · · ··composite, we have to do the homogenization step.
19· · · ··And so in terms of the sample preparation and
20· · · ··sample homogenization we remove that from the
21· · · ··process because that's where we see variability in
22· · · ··laboratories and how they prepare their samples.
23· · · ··So it's the one thing that we can really control in
24· · · ··this process, so we like to be able to remove that.
25· · · · · · · · ··So, for example, if we have -- if we have

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·1· · · ··cannabis flower, you know, we'll take, as I said,
·2· · · ··three, five, ten different groupings of cannabis
·3· · · ··flower, we'll mill it all together, and then we'll
·4· · · ··parse out a small subset of that sample to each lab
·5· · · ··for testing.
·6· · · · · · · · ··So they really do not do the preparation
·7· · · ··step and they don't do the homogenization step, but
·8· · · ··they do run through the rest of their method in
·9· · · ··order to test those samples.
10· ·Q· ··Can you tell me a little bit about what a sample --
11· · · ··just in general, if there is a way you can do it in
12· · · ··general, the sample preparation step looks like?
13· ·A· ··So sample preparation typically for us in
14· · · ··interlaboratory comparison is we will get those
15· · · ··samples out of their storage unit, put them all
16· · · ··together in whatever milling function we have
17· · · ··access to.··And this will be based on whatever
18· · · ··laboratory we have available to us during that
19· · · ··event.··And then we use, you know, it may be a
20· · · ··grinder, a blender, some mechanical device to
21· · · ··macerate the plant material.
22· · · · · · · · ··And then we mix it all up and make sure
23· · · ··that it is as homogenous as we possibly can with
24· · · ··the knowledge, of course, though that, you know,
25· · · ··it's a composite sample of numerous different

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·1· · · ··samples.··So that may look a little different from
·2· · · ··time to time.
·3· ·Q· ··And when we move on to the homogenization step
·4· · · ··what's that?
·5· ·A· ··So for homogenization typically when you're
·6· · · ··macerating a sample you want to make sure that
·7· · · ··everything is uniform, at least physically.··And
·8· · · ··that's about the best that we can do is ensure that
·9· · · ··there's physical uniformity there and say, you
10· · · ··know, all the little tiny pieces that have been
11· · · ··ground up in here are approximately the same size.
12· · · ··There's no big clumps of the cannabis flower that
13· · · ··are left.··Obviously that would provide an unfair
14· · · ··advantage to someone who got that sample.
15· · · · · · · · ··And generally what we'll do is we'll try
16· · · ··and free the kief, which is the loose trichome
17· · · ··hairs, we'll try and free that back into the
18· · · ··sample, shake it up, and just make sure that it's
19· · · ··as even as possible so that all of the labs are
20· · · ··getting as similar of a sample as they possibly
21· · · ··can.
22· ·Q· ··Do you expect some variation?
23· ·A· ··Absolutely.··Yes.··Particularly when it comes to
24· · · ··things like microbials.
25· ·Q· ··Okay.··So those two steps are done, and then the

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·1· · · ··samples are passed out to every lab participating
·2· · · ··in the interlaboratory test?
·3· ·A· ··Correct.
·4· ·Q· ··Then what happens from that point?
·5· ·A· ··So from that point those folks who took the sample
·6· · · ··will go back to their home laboratories and then
·7· · · ··they'll run their series of tests on there.
·8· · · · · · · · ··Of course, it's relevant, depending on
·9· · · ··the matrix, what tests they're going to run.··For
10· · · ··example, in cannabis flower we wouldn't have them
11· · · ··run a residual solvent test because it's not
12· · · ··required in our testing panel, but they will run
13· · · ··whatever the required testing panel is for that
14· · · ··matrix type.··And then they'll do, you know, any
15· · · ··tests of their data, make sure that their quality
16· · · ··is within the parameters that it's supposed to be.
17· · · ··And then they report that out in Metrc as a
18· · · ··proficiency test sample.
19· · · · · · · · ··And so from there we get the data back at
20· · · ··the CRA and we can combine that, or combine the
21· · · ··data to compare it, and then we can make
22· · · ··assumptions based on what data we get back.
23· ·Q· ··Is this a pass/fail type thing, or why do we do
24· · · ··these?
25· ·A· ··It is not a pass/fail type thing.··As I said in the

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·1· · · ··beginning I -- admittedly this is not a perfect
·2· · · ··system.··It's a basic replicate of what we would
·3· · · ··like to see for a proficiency test, but there are
·4· · · ··absolutely limitations to it.··And because there
·5· · · ··are limitations to it we would never treat it as a
·6· · · ··pass/fail situation.··It really only gives us an
·7· · · ··indication as to how testing is going in the
·8· · · ··industry.··It may flag something for us to look
·9· · · ··into further at which point we would contact the
10· · · ··laboratory and follow up from there using, you
11· · · ··know, requests for internal audit and things of
12· · · ··that nature.
13· ·Q· ··If there are issues or deviations in either the
14· · · ··sampling prep or the homogenization step of
15· · · ··someone's potency would that be something that
16· · · ··would cause one of these red flags in your
17· · · ··interlaboratory comparisons?
18· ·A· ··In a roundabout way.
19· · · · · · · · ··So because we actually have the ability
20· · · ··to remove the sample prep and homogenization
21· · · ··portion of it the only thing that that would really
22· · · ··show us is if there was some sort of a difference
23· · · ··in potency.··And the reason that is, is because the
24· · · ··kief, those trichomes again that come off of the
25· · · ··plant material, are going to be ground up all

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·1· · · ··together.··So even if the buds that -- that were
·2· · · ··different potencies going in had different
·3· · · ··potencies, a number of those trichomes are going to
·4· · · ··get knocked off, and they're going to get
·5· · · ··redistributed through that plant material.
·6· · · · · · · · ··So if we saw that there was a sample prep
·7· · · ··and homogenization issue we would see that then
·8· · · ··coming out in the interlaboratory proficiency
·9· · · ··tests.
10· ·Q· ··And Viridis, both North and Lansing, participated
11· · · ··in these interlaboratory comparison tests; correct?
12· ·A· ··That is correct.
13· ·Q· ··And how did their results fare in comparison to
14· · · ··other laboratories?
15· ·A· ··So when compared to other laboratories their
16· · · ··potencies were actually spot on.
17· · · · · · · · ··There's very little deviation when it
18· · · ··comes to potencies in these interlaboratory
19· · · ··comparison tests, which is not the case when we're
20· · · ··looking at day-to-day reporting.
21· · · · · · · · ··And so that was also a flag for us.··We
22· · · ··noted that by removing the sampling and
23· · · ··homogenization steps that we were getting potencies
24· · · ··very, very similar to one another and within the
25· · · ··relative standard deviation that we would expect

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·1· · · ··and that would be allowable based on the number of
·2· · · ··laboratories that were reporting in those studies.
·3· ·Q· ··So what did that tell you in regards to any
·4· · · ··concerns about potency you had for Viridis
·5· · · ··locations?
·6· ·A· ··That confirmed my suspicions and concerns that
·7· · · ··there was something going on in their sampling and
·8· · · ··homogenization steps that was awry.
·9· ·Q· ··And at this point if we were to stop, we were
10· · · ··talking about November of 2020, what was the
11· · · ··approved standard operating procedure on file for
12· · · ··Viridis?··Do you keep track of them by date or do
13· · · ··you label them by date?··What was that?
14· ·A· ··So for Viridis we do have to keep track of them by
15· · · ··date.··We had talked to them historically about
16· · · ··what that is they're supposed to do for ISO
17· · · ··compliance, and for compliance with us it would be
18· · · ··helpful if they could track them based on revision
19· · · ··numbers, that they would only track them based on
20· · · ··dates.··So we also tracked them based on date.
21· ·Q· ··Okay.
22· ·A· ··That being -- sorry, Sarah.
23· ·Q· ··No.··Go ahead.··Sorry.
24· ·A· ··That being said, the last potency method that we
25· · · ··had approval for them on was dated May of 2020.

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·1· ·Q· ··And can you tell me what the steps were in that --
·2· · · ··in that standard operating procedure?
·3· ·A· ··So much as I described with the interlaboratory
·4· · · ··proficiency test the steps in that procedure were
·5· · · ··to take the sample, and an important distinction
·6· · · ··here is this sample is a single sample from a
·7· · · ··single harvest batch from a single cultivator.
·8· · · ··They are not mixed samples.
·9· · · · · · · · ··And so they would take an aliquot, some
10· · · ··subset amount, put it into a grinding tub.··They
11· · · ··would put their grinding media or grinding balls in
12· · · ··there and shake it up essentially using a paint
13· · · ··shaker.··And then what they would do is aliquot
14· · · ··some amount of that.··It's supposed to be based on
15· · · ··1 gram per their procedure.··And then take that,
16· · · ··put it in a separate jar, and then begin filling it
17· · · ··with some sort of solvent solution in order to
18· · · ··perform their extraction.
19· ·Q· ··You said it should be 1 gram.··You were having some
20· · · ··discussions about that 1 gram approximately with
21· · · ··Viridis at that point in time; correct?
22· ·A· ··Yes, I was.
23· · · · · · · · ··So very early on back in 2019, like I
24· · · ··said, when their method first got approved we had
25· · · ··some questions about how and why they were using

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·1· · · ··1 gram of sample.··And Michele Glinn actually
·2· · · ··responded back and said the AOAC prescribes that,
·3· · · ··you know, it's best to use 1 gram of sample because
·4· · · ··that provides the most consistent relative standard
·5· · · ··deviation.··And we want our relative standard
·6· · · ··deviation to be low.··We don't want things to
·7· · · ··deviate, right, because we want to be accurate and
·8· · · ··precise.
·9· · · · · · · · ··And she also said that with lower sample
10· · · ··size you start to see an increase in relative
11· · · ··standard deviation which I have also found to be
12· · · ··true in practice.
13· · · · · · · · ··And then fast-forward a year to November
14· · · ··of 2020, and they have reported to us that they
15· · · ··were using as little as 0.2 grams for their sample
16· · · ··size.
17· · · · · · · · ··So we had a conversation because their
18· · · ··validation -- or their verification, excuse me --
19· · · ··was based on 1 gram, their methods stated that they
20· · · ··were using 1 gram, yet in practice they were
21· · · ··deviating from that by using only as little as 0.2
22· · · ··grams of that ground flower sample to perform an
23· · · ··extraction which, as stated by Michele herself in
24· · · ··the AOAC, can increase the amount of deviation,
25· · · ··relative standard deviation, in analysis and data.

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·1· · · · · · · · ··MS. HUYSER:··May I share my screen, Your
·2· · · ··Honor?
·3· ·Q· ··(MS. HUYSER) I am going to show you,
·4· · · ··Ms. Patterson -- let me get this up here.··Where
·5· · · ··did it go.··There it is.
·6· · · · · · · · ··Can you see what is on the screen?
·7· ·A· ··I can now, yes.
·8· ·Q· ··Thank you.··This has been marked as Petitioner's
·9· · · ··proposed Exhibit 1.
10· · · · · · · · ··Do you recognize what this is?
11· ·A· ··Yes, this is one of Viridis's methods.
12· ·Q· ··And do you -- if I scroll through it can you tell
13· · · ··me which one?··Are you able to identify which one
14· · · ··that it is?
15· ·A· ··So this method appears to be the May 2020 method
16· · · ··because it -- it looks like -- will you go just
17· · · ··back up for me?··Thank you so much.
18· · · · · · · · ··Yeah, approximately 1 gram, scraped,
19· · · ··homogenized -- yes, this must be the May of 2020
20· · · ··method.
21· ·Q· ··Obviously you recognize what it is based on its
22· · · ··contents?
24· ·Q· ··And, obviously, it comes from Viridis from your
25· · · ··understanding based on, again, what it looks like?

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·2· ·Q· ··Have there been any alterations made to the
·3· · · ··verbiage or the wording in this from the last time
·4· · · ··that you have seen it or reviewed it?
·5· ·A· ··No.
·6· ·Q· ··So do you believe that it accurately reflects the
·7· · · ··May of 2020 potency sampling standard operating
·8· · · ··procedure?
·9· ·A· ··Yes.
11· · · ··Honor, I would ask that Petitioner's 1 be admitted.
12· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, any objection?
13· · · · · · · · ··MR. RUSSELL:··Your Honor, I don't have
14· · · ··any objection.
15· · · · · · · · ··I guess I thought the CV was 1.··Was I
16· · · ··wrong about that?
17· · · · · · · · ··MS. HUYSER:··Sorry.··I'm using the
18· · · ··numbers that were proposed as a proposed marked.
19· · · ··So yeah, the CV was I believe 52 or 51?
20· · · · · · · · ··MR. RUSSELL:··So this will be 1?
21· · · · · · · · ··MS. HUYSER:··Yes.
22· · · · · · · · ··MR. RUSSELL:··Okay.··That's fine.··No
23· · · ··objection.
24· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Petitioner
25· · · ··Exhibit 1 is admitted.

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·2· · · · · · · · ··(CRA Exhibit 1 is admitted.)
·3· · · · · · · · ··MS. HUYSER:··They'll coincide with what
·4· · · ··they were marked with when we attached them.
·5· · · · · · · · ··MR. RUSSELL:··Yeah, that's fine, Sarah.
·6· · · ··Thank you.
·8· ·Q· ··(MS. HUYSER) All right.··So, Ms. Patterson, again,
·9· · · ··can you tell me what this -- what you would expect
10· · · ··to see someone doing per this standard operating
11· · · ··procedure?
12· ·A· ··So based on this standard operating procedure and
13· · · ··the verification that had previously accompanied it
14· · · ··we would expect that the laboratory technician,
15· · · ··whoever was performing this, would take 1 gram of
16· · · ··sample, as little as 0.9 grams, as much as 1.1
17· · · ··gram, and then that would be the homogenized sample
18· · · ··and using this as for the extraction process.
19· · · · · · · · ··To further clarify, prior to weighing
20· · · ··that sample we would expect that the sample is in
21· · · ··an amber container, that it has been homogenized
22· · · ··according to, you know, I think it says agitating
23· · · ··at 1,650 cycles per minute for 30 seconds, that it
24· · · ··would be shaken several times by hand, that it
25· · · ··would be opened, and that the technician would

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·1· · · ··essentially grab some sort of sterile instrument to
·2· · · ··push all the trichomes from the top and the side
·3· · · ··and the bottom of that amber container back into
·4· · · ··the plant material and then gently kind of swirl it
·5· · · ··around to ensure that the sample was homogenized.
·6· · · · · · · · ··And to be clear, when they are taking any
·7· · · ··of that sample out and putting it into the
·8· · · ··extraction vial as they state we would expect that
·9· · · ··they're avoiding any large particles that have not
10· · · ··been homogenized thoroughly.
11· ·Q· ··And since this May of 2020 procedure has the CRA
12· · · ··approved any other procedures pertaining to potency
13· · · ··for Viridis?
14· ·A· ··No.
15· ·Q· ··So we are saying this is the one that should be
16· · · ··used as we walk through anything from May of 2020
17· · · ··to current?
19· ·Q· ··So in November of 2020 did you learn of a new
20· · · ··method?
21· ·A· ··We learned of a new method, yes.··And there were
22· · · ··some modifications that were made to that method
23· · · ··from the May of 2020 method.
24· ·Q· ··When -- any time you have -- oops.··Sorry, I
25· · · ··thought you were talking.

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·1· · · · · · · · ··MR. RUSSELL:··Yeah, I was.··And we can go
·2· · · ··ahead with this question, I was just going to ask
·3· · · ··the judge if we could take a ten-minute break.··But
·4· · · ··go ahead with this question if you want to wait
·5· · · ··till after that.
·6· · · · · · · · ··MS. HUYSER:··It doesn't matter.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··We're going to break
·8· · · ··for lunch in a couple of minutes.··If you want to
·9· · · ··break now we can break now and reconvene at 1:00.
10· · · · · · · · ··MR. RUSSELL:··That's fine, yeah.··I -- if
11· · · ··Sarah wants to continue this line of questioning I
12· · · ··don't want to interrupt her.··So . . .
13· · · · · · · · ··MS. HUYSER:··I'm already stopped.··If we
14· · · ··want to break till one that's fine.
15· · · · · · · · ··JUDGE GOLDSTEIN:··And just before we do
16· · · ··break just let me indicate just a housekeeping
17· · · ··matter.
18· · · · · · · · ··I'm noticing -- because this is
19· · · ··consolidated now assigning the Petitioner and the
20· · · ··Respondent labels might be a little confusing.··So
21· · · ··for all of the Agency exhibits they're going to be
22· · · ··marked as CRA exhibits.··Okay?
23· · · · · · · · ··MS. HUYSER:··Okay.··Absolutely.
24· · · · · · · · ··JUDGE GOLDSTEIN:··Starting with numbers
25· · · ··so -- and for Viridis we'll just mark you as

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·1· · · ··Viridis exhibits?
·2· · · · · · · · ··MR. RUSSELL:··Sounds good.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··I don't know if you
·4· · · ··premarked them with numbers, but even if you have
·5· · · ··that's fine.··It's still identified by party.
·6· · · ··So -- okay?··Just so everybody's aware of that.
·7· · · ··They will be admitted as CRA exhibits or Viridis
·8· · · ··exhibits.··Okay?
·9· · · · · · · · ··So hopefully -- or we'll adjourn for
10· · · ··lunch now and reconvene at 1:00.··It's 11:45 and
11· · · ··we're off the record.
12· · · · · · · · ··(Break taken at 11:45 AM)
13· · · · · · · · ··(Break concluded at 1:02 PM)
14· · · · · · · · ··JUDGE GOLDSTEIN:··We are back on the
15· · · ··record in the matter of Viridis Laboratories, LCC,
16· · · ··and Viridis North, LLC, versus Cannabis Regulatory
17· · · ··Agency, consolidated Docket Number 21-029794,
18· · · ··et al.··The time is 1:01 PM.··Actually 1:02 PM.
19· · · · · · · · ··And I believe, Ms. Huyser, we left off --
20· · · ··you were continuing with your questioning I
21· · · ··believe.
22· · · · · · · · ··MS. HUYSER:··Yes, sir.··Thank you.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Sure.··Go ahead.
24· ·Q· ··(MS. HUYSER) Before we left for lunch,
25· · · ··Ms. Patterson, we were talking about potency SOPs

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·1· · · ··or standard operating procedures, but I want to go
·2· · · ··back and just ask a general SOP question.
·3· · · · · · · · ··We talked about the initial SOPs that
·4· · · ··were established.
·5· · · · · · · · ··Is there a procedure, if you want to
·6· · · ··change or modify a standard operating procedure,
·7· · · ··that must be followed?
·8· ·A· ··Yes, there is.
·9· · · · · · · · ··So there's essentially two pathways to
10· · · ··follow.··So with any SOP it's commonly accepted
11· · · ··through ISO and other scientific bodies that if
12· · · ··you're going to make a change that is
13· · · ··nonsubstantive, so you're clarifying a piece of
14· · · ··information without changing something substantive,
15· · · ··you are fixing a grammatical error or adding a
16· · · ··period, those types of things are something that a
17· · · ··laboratory or anyone would be free to do just on
18· · · ··their own volition.
19· · · · · · · · ··Now, if you're going to make a change
20· · · ··that would potentially impact the outcome of the
21· · · ··data, then that is something that would require the
22· · · ··SOP to be resubmitted to the Agency and then
23· · · ··reviewed to ensure that that change, even if it
24· · · ··seems minimal, doesn't impact the total outcome of
25· · · ··the procedure itself.

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·1· ·Q· ··So how do you -- what happens with the review?··Is
·2· · · ··it on a particular form again?··You mentioned a
·3· · · ··living document.··How does it come to you?
·4· ·A· ··So those types of things would come to us through
·5· · · ··the same process that any SOP would come to us.··We
·6· · · ··would expect that it comes through as an SOP, any
·7· · · ··associated documents, logs, tracking, quality
·8· · · ··assurance things, as well as a PT to ensure, again,
·9· · · ··that that change is not going to affect the outcome
10· · · ··of the data.··And that would also require the
11· · · ··associated data package from the verification that
12· · · ··ensures that that change isn't going to affect the
13· · · ··outcome of the data.
14· ·Q· ··You mentioned that it comes with a PT.··Is that a
15· · · ··proficiency test?
16· ·A· ··Yes, it is.
17· ·Q· ··Okay.··And if you don't get all of these documents
18· · · ··do you review the possible change?
19· ·A· ··No, we will not review the possible change.··We may
20· · · ··reach out and ask additional questions to try and
21· · · ··help ascertain what it is that the licensee's
22· · · ··trying to do to see if we can point them in the
23· · · ··right direction, but we're not going to review that
24· · · ··document and provide an actual response to that
25· · · ··because it doesn't meet our qualifications.

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·1· ·Q· ··So we were talking a little bit about November of
·2· · · ··2020.··Do you recall having communication with
·3· · · ··Viridis regarding a new potential method or some
·4· · · ··type of modification that may have happened or is
·5· · · ··happening to their potency SOP?
·6· ·A· ··So around that time, like I mentioned before, we
·7· · · ··had noticed that there was some changes that seemed
·8· · · ··to be happening with the method.··We noticed that
·9· · · ··the potency was increasing.··And I had recommended
10· · · ··to them that they look at their method and
11· · · ··determine what it is that they mean by
12· · · ··approximately 1 gram.··Because, as I had said
13· · · ··before, in that interlaboratory proficiency test
14· · · ··they told us that they would use as little as 0.2
15· · · ··grams.··And that is a vast deviation from using
16· · · ··1 gram as they did in their verification and as
17· · · ··their SOP stated that they would.
18· ·Q· ··And so who did you reach out to or who did you
19· · · ··communicate with?
20· ·A· ··So typically at that time I was primarily
21· · · ··communicating with Michele Glinn.··She frequently
22· · · ··would cc Greg Michaud or Todd Welch on those, but
23· · · ··primary communications were with Michele.
24· ·Q· ··And at this part of November of 2020 were you a
25· · · ··supervisor?··Were you still the LSS assigned to it?

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·1· · · ··What was your role?
·2· ·A· ··So in November of 2020 I had officially taken over
·3· · · ··the role of manager of the legal and scientific
·4· · · ··section, so I was managing the laboratory scientist
·5· · · ··specialists at that point in time.
·6· ·Q· ··When you said you spoke to Dr. Glinn, did you speak
·7· · · ··to Michele Glinn just for Viridis Lansing or on
·8· · · ··behalf of both Viridis locations?
·9· ·A· ··On behalf of both Viridis locations since we were
10· · · ··seeing the issue at both locations.··And she
11· · · ··provides oversight at both locations, at least in
12· · · ··some capacity.
13· ·Q· ··So tell me about those communications.
14· ·A· ··So one of the first things that we communicated
15· · · ··with her is that we'd like to have the samples that
16· · · ··were requested during the potency audit reprepped
17· · · ··at their appropriate 1 gram weight.··So we had
18· · · ··requested a potency audit occur.··We noticed that
19· · · ··there was a high level of total THC that was being
20· · · ··reported.
21· · · · · · · · ··And when those results came back to us
22· · · ··that's when we really noted that they were prepping
23· · · ··their samples at a weight that was around 0.2 grams
24· · · ··or anywhere up to 1 gram.··So I had asked her to
25· · · ··please make sure that they had reprepped those

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·1· · · ··examples according to their procedure at 1 gram
·2· · · ··consistently.··And then I asked her also why they
·3· · · ··were not following their SOPs that had been
·4· · · ··approved.
·5· ·Q· ··And did she respond to that question?
·6· ·A· ··She had responded saying that she felt that
·7· · · ··approximately meant anywhere from one-tenth of a
·8· · · ··gram to 1 gram despite the fact that that is not
·9· · · ··what the term approximate means and it also does
10· · · ··not fall in line with what their verification
11· · · ··stated and what she reiterated to us in our
12· · · ··communications about her verification where she
13· · · ··explicitly stated that they should be prepping at
14· · · ··1 gram because that's what the AOAC deems
15· · · ··acceptable and that's the best way to ensure the
16· · · ··lowest relative standard deviation which, of
17· · · ··course, can help us ensure accurate, precise,
18· · · ··consistent results.
19· ·Q· ··Did they introduce any other steps for -- that you
20· · · ··had first learned about in this SOP or in that
21· · · ··process?
22· ·A· ··At this point in time what they had attempted to do
23· · · ··was to clarify what the word approximate meant.
24· · · ··And I believe that they had attempted to say that
25· · · ··approximate meant anywhere from 0.4 grams up to

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·1· · · ··either 1.2 or 1.4 grams.··I'd have to look at it to
·2· · · ··clarify that information.
·3· ·Q· ··And where did you move from there with this
·4· · · ··conversation?
·5· ·A· ··So from there it felt like the conversation was
·6· · · ··getting a little bit argumentative, so I really
·7· · · ··wanted to kind of go back, clear the record, and
·8· · · ··just let them know they exactly what it was that we
·9· · · ··needed them to do to be in compliance with our
10· · · ··SOPs.
11· · · · · · · · ··And so I let Michele know that
12· · · ··approximately is not under any circumstances
13· · · ··anywhere from one-tenth of a gram to 1 gram, that
14· · · ··they needed to really clarify what they were going
15· · · ··to be using in terms of prepping their samples and
16· · · ··that it should be near 1 gram.
17· · · · · · · · ··Additionally I asked them to provide a
18· · · ··corrective action report for why those samples were
19· · · ··exceeding 1 gram, and then to go back and fix all
20· · · ··those samples that were prepped outside of that
21· · · ··range because, as I said, again, if they were
22· · · ··prepping outside of that range, we cannot ensure
23· · · ··precision, accuracy of those results.
24· · · · · · · · ··And then I also reminded her that it's
25· · · ··absolutely critical that the laboratory follow

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·1· · · ··their standard operating procedures as they were
·2· · · ··approved by the Agency.
·3· · · · · · · · ··MR. RUSSELL:··I'm going to object for a
·4· · · ··lack of foundation.··I believe what the witness is
·5· · · ··testifying to is related to an email chain but yet
·6· · · ··continually describes this as a conversation and
·7· · · ··described it as argumentative.··So I think that
·8· · · ··the -- they need to lay a foundation of what the
·9· · · ··actual conversation is between the two parties.
10· · · · · · · · ··JUDGE GOLDSTEIN:··Response, Counsel?
11· · · · · · · · ··MS. HUYSER:··If you're asking for a
12· · · ··medium, then I can ask that question, sure.··And we
13· · · ··were getting there.··But as far as the actual
14· · · ··conversation, what Ms. Patterson is describing is
15· · · ··their back and forth, which would constitute their
16· · · ··conversation.
17· · · · · · · · ··MR. RUSSELL:··Okay.··It's feeling as
18· · · ··if --
19· · · · · · · · ··JUDGE GOLDSTEIN:··Is there an email?··Is
20· · · ··there an email associated with this conversation or
21· · · ··is this a telephone call?
22· · · · · · · · ··MS. HUYSER:··Yes, sir, it is an email.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Emails.··Okay.
24· · · · · · · · ··And are they in the record or proposed
25· · · ··exhibits somewhere?

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·1· · · · · · · · ··MS. HUYSER:··They are proposed exhibits.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Are you getting to that
·3· · · ··point?
·4· · · · · · · · ··MS. HUYSER:··Yep.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Go ahead.
·7· ·Q· ··(MS. HUYSER) So I am going to, which is where we
·8· · · ··were going here, put up what has been marked as --
·9· · · ··well, in a series, proposed Exhibit 18, and I'm
10· · · ··going to have you take a look here.··Make sure I
11· · · ··have -- oh, I apologize.··Bear with me for one
12· · · ··second because we were working through that.
13· · · · · · · · ··Well, we will get there.··I'm not going
14· · · ··to throw myself off my line, to be completely
15· · · ··honest.
16· · · · · · · · ··So, as I was stating, Ms. Patterson, your
17· · · ··communications were over email back and forth with
18· · · ··Dr. Glinn; correct?
19· ·A· ··Yes.
20· ·Q· ··And did these -- was this just one set of emails,
21· · · ··or were you having consistent sets of emails back
22· · · ··and forth?
23· ·A· ··They were consistent sets of emails back and forth.
24· ·Q· ··Okay.··And at some point with -- did they ever give
25· · · ··you in the month of November what they proposed as

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·1· · · ··a possible standard operating procedure change or
·2· · · ··what they were doing at that stage?
·3· ·A· ··I'm not entirely sure.··I believe that they may
·4· · · ··have.··If not, it came later in December.
·5· · · · · · · · ··It's hard to keep track of those because,
·6· · · ··as I said, they don't have the appropriate tracking
·7· · · ··on them.
·8· ·Q· ··At this point in time I am going to show you what's
·9· · · ··been marked as CRA's proposed exhibit, and it is 2.
10· · · · · · · · ··Hold on one second, please.
11· · · · · · · · ··Can you see my screen?
12· ·A· ··Yes, I can.
13· ·Q· ··Okay.··Take a second to look at what this is.··And
14· · · ··I can scroll down slowly if you like.··And tell me
15· · · ··if you recognize what this is.
16· ·A· ··Yes, if you could keep scrolling down slowly for
17· · · ··me.··Thank you.
18· · · · · · · · ··Okay.··Yes.··So this would be what I
19· · · ··believe they're terming the November SOP, but I
20· · · ··believe we received this actually in December of
21· · · ··2020.
22· ·Q· ··And tell me how it is different or what makes it
23· · · ··different from anything that you have previously
24· · · ··received.
25· ·A· ··So the May of 2020 method, if you recall, said that

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·1· · · ··they were going to take the plant material and
·2· · · ··homogenize it entirely.··They may scrape the sides,
·3· · · ··the top, the bottom of the jars, but they would
·4· · · ··reintroduce that kief essentially just by shaking
·5· · · ··it around and not any other way.
·6· · · · · · · · ··Additionally, formally it said that they
·7· · · ··were going to use 1 gram.··And here what they've
·8· · · ··done is actually clarified what they believed to be
·9· · · ··approximately 1 gram as an acceptable range of 0.4
10· · · ··to 1.2 grams.··They also added -- let's see here.
11· · · ··Powder.··Homogenous sample.
12· · · · · · · · ··They also added that they would be
13· · · ··scraping material from the ceramic grinding balls
14· · · ··and mixed in with the ground material.··So that
15· · · ··actually was not included in the May 2020 method
16· · · ··either.
17· · · · · · · · ··They also changed the speed for which
18· · · ··they would be doing the vortexing.··It says "The
19· · · ··vial is then packed and placed in a Fisher brand,"
20· · · ··blah blah blah, "for 15 minutes at 500 RPM."··That
21· · · ··was changed.··The RPMs were reduced.
22· · · · · · · · ··And then it also has this additional here
23· · · ··where it states "If a noncompliant sample contains
24· · · ··only a very small amount of flower material it may
25· · · ··be ground with one ceramic grinding ball in a screw

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·1· · · ··cap conical vial," etc.
·2· ·Q· ··Okay.··So just to get my housekeeping portion out
·3· · · ··of the way, obviously you recognize this as what?
·4· · · ··Is this what the CRA would refer to as the December
·5· · · ··proposed SOP?
·6· ·A· ··That is correct, yes.
·7· ·Q· ··Have there been any changes or alterations to this
·8· · · ··document in the form that you have last seen it?
·9· ·A· ··No.
10· ·Q· ··This accurately reflects what was provided to you
11· · · ··from Viridis collectively, both Viridises?
13· · · · · · · · ··MS. HUYSER:··Okay.··At this point in
14· · · ··time, Your Honor, we would ask that CRA proposed
15· · · ··Exhibit 2 be admitted.
16· · · · · · · · ··MR. RUSSELL:··Yeah, Your Honor, I'm a
17· · · ··little bit confused.··Number one, the questioning
18· · · ··from Ms. Huyser related to an email chain of
19· · · ··November 2020, which I do know was a proposed
20· · · ··exhibit, at least from -- from Viridis North and
21· · · ··Viridis Laboratories, and then I thought that was
22· · · ··going to be introduced.··And now that we see this,
23· · · ··which is I believe a portion of an investigative
24· · · ··report, not an entire report.··I don't disagree
25· · · ··that the method that is set forth -- I believe this

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·1· · · ··was what was provided as part of that email, but
·2· · · ··this is, I think, a portion of an investigative
·3· · · ··report in 2020.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So why is
·5· · · ··this -- if it -- is this looks like an excerpt from
·6· · · ··Viridis's actual SOP?··Is that what this is?
·7· · · · · · · · ··MS. HUYSER:··It is -- it is a portion
·8· · · ··that contains Viridis's SOP that was submitted via
·9· · · ··email in December of 2020.
10· · · · · · · · ··JUDGE GOLDSTEIN:··Right.··So that's the
11· · · ··context in which this is cited here.··Okay?
12· · · · · · · · ··Do you have any objection, Counsel, to
13· · · ··the admissibility of this SOP?
14· · · · · · · · ··MR. RUSSELL:··I don't have an objection
15· · · ··to the admissibility of the SOP, I have an
16· · · ··objection that they're introducing exhibits that
17· · · ··aren't full exhibits.··But no, I believe the SOP is
18· · · ··a correct, accurate depiction of what was provided
19· · · ··in November and then again in December.
20· · · · · · · · ··MS. HUYSER:··Would you like me to
21· · · ··respond, Your Honor?
22· · · · · · · · ··JUDGE GOLDSTEIN:··Go ahead.
23· · · · · · · · ··MS. HUYSER:··If it's a full and accurate
24· · · ··representation of what the SOP was that's the
25· · · ··purpose for its admission.··If we were to look at

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·1· · · ··having to admit the entire contents of an
·2· · · ··investigation report with every reference, that was
·3· · · ··not how it was attached to the exhibits list as it
·4· · · ··was provided, and that means we would be admitting
·5· · · ··duplicate copies of the entire report multiple
·6· · · ··times or having to go through and do it this way.
·7· · · · · · · · ··This was not objected to when we filed
·8· · · ··our exhibit list as far as pulling portions out.
·9· · · ··And in the motion in limine counsel responded and
10· · · ··acknowledged that they have received everything
11· · · ··since anything was provided.
12· · · · · · · · ··So they may have everything in full.··I
13· · · ··don't believe that there was any requirement that
14· · · ··if they acknowledge what we're offering it for,
15· · · ··which is to show that it is the actual proposed or
16· · · ··what was submitted, then I don't believe that we
17· · · ··need to submit the entire investigation report.··I
18· · · ··think that if we had to submit something in full
19· · · ··would be if I was only providing one paragraph of
20· · · ··this, not two.··Or not the complete SOP proposed.
21· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··I will
22· · · ··admit CRA Exhibit 2 into evidence.
25· · · · · · · · ··MR. RUSSELL:··So just to clarify, I think

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·1· · · ··Ms. Huyser referenced that -- and I think it was
·2· · · ··Exhibit 18 or 16 -- that was the email chain.
·3· · · · · · · · ··Were you introducing that, or no?
·4· · · · · · · · ··MS. HUYSER:··We will be getting through
·5· · · ··all of them, just I have a -- as you know as an
·6· · · ··attorney we have a path we follow.··So once I get
·7· · · ··there I will be admitting emails.··18 and 16 are
·8· · · ··portions that pertain to studies that will be
·9· · · ··referenced.··But yes, we do have the emails that
10· · · ··are on our exhibit list.
11· · · · · · · · ··May I continue, Your Honor?
12· · · · · · · · ··JUDGE GOLDSTEIN:··Oh, yes.··I'm sorry.
13· · · ··Go ahead.
15· ·Q· ··(MS. HUYSER) So, Ms. Patterson, as you outlined,
16· · · ··you're going through and there were a handful of
17· · · ··things that you had never seen before as they were
18· · · ··presented to you in this document; correct?
19· ·A· ··That's correct.
20· ·Q· ··So just to make sure that I'm not putting words
21· · · ··into your mouth, was this ever approved as
22· · · ··something that Viridis North or Viridis Lansing
23· · · ··should be using in their lab?
24· ·A· ··No, it was not.··This is merely the beginning of a
25· · · ··series of conversations that we had about the

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·1· · · ··deviations that they were performing to the
·2· · · ··approved SOP that was approved in May of 2020.
·3· ·Q· ··Is this document alone sufficient to have a
·4· · · ··validation reviewed or an SOP modified through the
·5· · · ··CRA?
·6· ·A· ··Yes, absolutely.··We would consider in particular
·7· · · ··the addition of the scraping of material from the
·8· · · ··ceramic grinding balls a reason to have an
·9· · · ··additional validation.··We would consider the term
10· · · ··approximate referring to 0.4 to 1.2 grams being a
11· · · ··reason to have the method validated.
12· · · · · · · · ··And then we would also have pause and
13· · · ··concern, just generally, about the noncompliance
14· · · ··samples in particular.··We want them to demonstrate
15· · · ··that that was a valid way to actually prepare those
16· · · ··samples in the laboratory space and would warrant
17· · · ··providing validation as well.
18· ·Q· ··And if this was emailed to you in and of itself,
19· · · ··would you still require more documents to be
20· · · ··attached for this to warrant a complete review on
21· · · ··your end?
22· ·A· ··Absolutely.··When an SOP comes to us it needs to be
23· · · ··accompanied by, as I said, either a verification or
24· · · ··in this case a validation to substantiate that the
25· · · ··changes that were made to the SOP are not

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·1· · · ··substantive.··And then it would also include any
·2· · · ··additional logs, quality assurance material, as
·3· · · ··well as a proficiency test.
·4· ·Q· ··And as we continue to work through this process you
·5· · · ··are continuing to have conversations via email with
·6· · · ··individuals at Viridis; correct?
·7· ·A· ··Yes, that is correct.
·8· ·Q· ··Are you having any other forms of conversations
·9· · · ··throughout the month of November moving into
10· · · ··December of 2020?
11· ·A· ··Not that I can recall.··I think primarily
12· · · ··everything is occurring via email just to make sure
13· · · ··that there was a clear record on both sides so that
14· · · ··both parties could understand what had been
15· · · ··discussed.
16· ·Q· ··At some point -- and, obviously, we'll get to the
17· · · ··email exchanges here -- but at some point in the
18· · · ··process the labs are always up for inspections;
19· · · ··correct?
21· ·Q· ··And how often is a lab expected?
22· ·A· ··Semi-annually, so twice a year.··Unless there's
23· · · ··something that -- you know, if there's an addition
24· · · ··of a prelicensure or some other type of inspection
25· · · ··that would need to occur.

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·1· ·Q· ··And these issues as they were arising had nothing
·2· · · ··to do directly with the inspection that was
·3· · · ··pending.··Those were not contingent upon one or the
·4· · · ··other; correct?
·5· ·A· ··That is correct.··They are completely separate
·6· · · ··issues.
·7· ·Q· ··Okay.··I am going to show you here what has been
·8· · · ··marked as CRA's proposed Exhibit 5, if you'll bear
·9· · · ··with me for a second.
10· · · · · · · · ··All right.··Are you able to see that it
11· · · ··says Attachment 3 on top?··Are you able to see what
12· · · ··is on the screen?
13· ·A· ··Yes, I am.
14· ·Q· ··Okay.··I'm going to take an opportunity to scroll
15· · · ··through these real quickly so you can follow along.
16· ·A· ··Thank you.
17· ·Q· ··So this is the one that is marked as proposed
18· · · ··Exhibit 5.
19· · · · · · · · ··Do you have -- do you recognize what that
20· · · ··is?
21· ·A· ··Yes, I do.··It's an email between myself to Michele
22· · · ··Glinn, cc'd Greg and Todd as well, letting them
23· · · ··know that I generally had some concerns about the
24· · · ··high potency results that were coming from the
25· · · ··laboratory.

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·1· ·Q· ··Was this the start of those communications that we
·2· · · ··have been talking about?
·3· ·A· ··I would say this is about a month after those
·4· · · ··communications started happening.··We, as I stated,
·5· · · ··had had some initial communication about those high
·6· · · ··potency audits and that kind of started the
·7· · · ··communication.··But I would say the weight of the
·8· · · ··back and forth on these communications really
·9· · · ··started here on this email chain, December 2nd,
10· · · ··2020.
11· · · · · · · · ··MR. RUSSELL:··I'm going to object here to
12· · · ··the fact that I believe this here is not a complete
13· · · ··document.··I believe this is one email in a chain
14· · · ··that I believe started around November 20, 2020.
15· · · · · · · · ··MS. HUYSER:··Obviously we have marked our
16· · · ··December exhibits.··We did not include the entire
17· · · ··chain.··I know that Viridis's attorneys and
18· · · ··counsels have them if they feel as though they need
19· · · ··to admit the entire chain or a separate chain.
20· · · · · · · · ··This is the one that started December,
21· · · ··and we are going through the December emails that
22· · · ··have various back and forths.··That's what we
23· · · ··intend on admitting.
24· · · · · · · · ··Obviously, Counsel can admit whatever
25· · · ··they would like to admit and however they would

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·1· · · ··like to admit it.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, do you have
·3· · · ··the rest of these email chains that you're
·4· · · ··referring to?
·5· · · · · · · · ··MR. RUSSELL:··Yes, I do, Your Honor, but
·6· · · ··I think it's misleading to the Court to only
·7· · · ··provide a section of the emails as opposed to the
·8· · · ··entire document.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So you're
10· · · ··concerned about a context issue?
11· · · · · · · · ··MR. RUSSELL:··I'm concerned about the
12· · · ··foundation for the entire document.··I think that
13· · · ··they have -- if they are going to admit this
14· · · ··conversation that now that she -- that
15· · · ··Ms. Patterson's testified extensively to then you
16· · · ··need to admit the entire document instead of just
17· · · ··pulling something out of the document.
18· · · · · · · · ··MS. HUYSER:··Ms. Patterson testified it's
19· · · ··been a series of various conversations over a long
20· · · ··time.··As we can see this is the start of another
21· · · ··email, and the foundation that would have to be
22· · · ··laid is that this is an accurate reflection of that
23· · · ··email, that it's not been changed.··And
24· · · ··Ms. Patterson can put it into context.··If there
25· · · ··are additional emails she's subject to

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·1· · · ··cross-examination.··But I don't believe that
·2· · · ··foundation would be an appropriate type of
·3· · · ··objection for this exhibit.
·4· · · · · · · · ··MR. RUSSELL:··This isn't the start of a
·5· · · ··new email I don't believe.··I believe you just
·6· · · ··stated that this is a part of a string of long
·7· · · ··emails, which, as I alluded to a few minutes ago,
·8· · · ··was started on November 20th, 2020.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Well,
10· · · ··Counsel, you can supply me the beginning of the
11· · · ··emails if you believe that I need a clearer picture
12· · · ··of what has occurred here.
13· · · · · · · · ··The document marked as CRA Exhibit 5 is
14· · · ··admitted.
17· ·Q· ··(MS. HUYSER) And, Ms. Patterson, again, can you
18· · · ··explain what the purpose of this email was?
19· ·A· ··The purpose of this email was to really get to the
20· · · ··heart of what was happening at the laboratory.
21· · · ··Keeping in mind, of course, this is, you know,
22· · · ··December of 2020 there, and around this period this
23· · · ··was the height of the COVID-19 pandemic, so a lot
24· · · ··of our communication -- well, in fact, all of our
25· · · ··communications were done virtually.

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·1· · · · · · · · ··And so it was -- it was an attempt to
·2· · · ··understand what has happened in the laboratory but
·3· · · ··also to provide a little bit of education about
·4· · · ··what made sense in terms of cannabis potency and
·5· · · ··cannabis testing from the scientific literature and
·6· · · ··what is commonly accepted in the scientific
·7· · · ··community for cannabis potency.
·8· · · · · · · · ··So I, obviously, as you see here in the
·9· · · ··introduction, mailed a little bit of information
10· · · ··and kind of explained what my concerns are letting
11· · · ··them know that I believe that there is something
12· · · ··wrong potentially in sample preparation and I had
13· · · ··some follow-up questions.
14· · · · · · · · ··So I wanted to -- I wanted to better
15· · · ··understand why the prep rate varied so greatly
16· · · ··based on their verification in their SOP.··I asked
17· · · ··them if they had done any studies.··I asked them if
18· · · ··they could provide me some additional information
19· · · ··about how they were handling those samples when
20· · · ··they came into the laboratory space.··And then I
21· · · ··also asked them some information about their
22· · · ··Geno/Grinder, which is essentially a grinding mill.
23· · · ··And that's used to crush up pulverized samples and
24· · · ··then homogenize them, essentially.
25· · · · · · · · ··So I really just was looking to see if I

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·1· · · ··could get some of my questions answered to see if I
·2· · · ··could better assist the licensee in troubleshooting
·3· · · ··what was going on with this potency method.
·4· ·Q· ··And you continued to have various email
·5· · · ··conversations and exchanges over the period of time
·6· · · ··about this issue; correct?
·8· ·Q· ··And ultimately at some point in time did you
·9· · · ··receive a response back answering your questions?
10· ·A· ··Yes, I believe I did.
11· ·Q· ··Okay.··Do you recognize what has been put on the
12· · · ··screen at this point in time?··And this is CRA
13· · · ··proposed Exhibit 6.
14· ·A· ··Yes, I do.
15· ·Q· ··Tell me what that is, please.
16· ·A· ··This is I believe Michele Glinn's responses to my
17· · · ··questions that were asked in the previous email.
18· ·Q· ··So the Exhibit 5 that was admitted, this is the
19· · · ··response that you received back?
20· ·A· ··Yes, that is correct.
21· ·Q· ··I'll scroll slowly through, and I'm going to get to
22· · · ··the bottom of this here.
23· · · · · · · · ··Do you -- have there been any changes or
24· · · ··alterations in the form of this document?
25· ·A· ··No, there have not.

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·1· ·Q· ··Okay.··So as you went through this, and you had
·2· · · ··gone through and walked through all those
·3· · · ··questions.··Did you have any additional concerns
·4· · · ··about the answers?
·5· ·A· ··I did.··There was some information in here that was
·6· · · ··not included in the approved May of 2020 method.
·7· · · ··In particular, you know, I think it's in the fifth
·8· · · ··point here, I ask how the lab makes certain that
·9· · · ··the resin is evenly distributed through the
10· · · ··homogenized sample.··And it stated that the resin
11· · · ··is usually evenly -- or usually -- resin is usually
12· · · ··quoted fine powdery material which makes it easier
13· · · ··to scrape and mix.··That doesn't necessarily make
14· · · ··sense logically based on how those ceramic grinding
15· · · ··media move throughout the sample.
16· · · · · · · · ··I asked also if they had performed a
17· · · ··validation, and this is a big portion here, in
18· · · ··order to ensure that the sample prep wasn't
19· · · ··affecting the outcome of the results in some sort
20· · · ··of significant way.··And they stated that they had
21· · · ··done in-house research studies but had concluded
22· · · ··that the ceramic beads that touched every part of
23· · · ··the sample during the homogenization process, it's
24· · · ··thoroughly mixed.
25· · · · · · · · ··But at no point in time did they state

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·1· · · ··that they had done a validation.··Which, of course,
·2· · · ··as I stated before, a validation would be required
·3· · · ··to ensure that this was not a completely
·4· · · ··substantive change that would change the outcome of
·5· · · ··those results in a significant way.
·6· · · · · · · · ··MS. HUYSER:··At this point, Your Honor, I
·7· · · ··am going to move for CRA proposed Exhibit 6 to be
·8· · · ··admitted.
10· · · · · · · · ··MR. RUSSELL:··I renew the same objection.
11· · · ··But I understand that Your Honor's going to admit
12· · · ··those, so I'll -- I agree to have them admitted.
13· · · · · · · · ··JUDGE GOLDSTEIN:··All right.
14· · · ··Respondent's Exhibit -- I'm sorry -- CRA Exhibit 6
18· · · · · · · · ··JUDGE GOLDSTEIN:··Go ahead, Counsel.
20· ·Q· ··(MS. HUYSER) So as we walk through this process,
21· · · ··we're now into December 2020, and the -- as we
22· · · ··talked about it a little bit a semi-annual
23· · · ··inspection was coming up?
25· ·Q· ··And tell me, what is a semi-annual inspection?

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·1· ·A· ··So a semi-annual inspection is something that's
·2· · · ··performed by the Agency's regulation officers as
·3· · · ··well as in the case of laboratories the LSS staff.
·4· · · ··And that's essentially just a high-level overview
·5· · · ··of the operations of the laboratory in this case to
·6· · · ··ensure that they're operating in compliance with
·7· · · ··our checklist which is based entirely upon the
·8· · · ··administrative rules that are active at that point
·9· · · ··in time.
10· ·Q· ··And you mentioned again COVID.··So how were
11· · · ··semi-annual inspections being conducted through
12· · · ··this period of time?
13· ·A· ··During this period of time all of our semi-annual
14· · · ··inspections were done remotely.··We were not
15· · · ··permitted to go on site in any location in case of
16· · · ··a -- except for in case of a dire emergency.
17· ·Q· ··And tell me the process.··I know that you said
18· · · ··remotely, so how -- is it live stream?··How are you
19· · · ··doing it?
20· ·A· ··So when we perform Viridis Laboratories semi-annual
21· · · ··inspections or any Viridis Laboratories inspection
22· · · ··we invite both parties to attend something either
23· · · ··like a Teams in our case or a Zoom if the licensee
24· · · ··were to prefer it, and then we hold a video
25· · · ··conference.··We go over the same information that

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·1· · · ··we would go over in person; however, it's done via
·2· · · ··teleconference.
·3· · · · · · · · ··And typically we would do the exact same
·4· · · ··things we would do on site.··We would open the
·5· · · ··conversation.··We would go through the checklist.
·6· · · ··Review any relevant documentation.··Potentially
·7· · · ··perform audits of methods as needed or audits of
·8· · · ··various spaces in the laboratory as needed with the
·9· · · ··caveat, of course, that we would ask that the
10· · · ··licensee bring their computer or video device with
11· · · ··them and allow us to travel with them to the
12· · · ··appropriate space in the laboratory so that we
13· · · ··would be able to witness whatever it was that they
14· · · ··were doing.
15· ·Q· ··Is there a checklist that's associated with
16· · · ··semi-annual inspections?
17· ·A· ··Yes, there is a checklist that's associated with
18· · · ··semi-annual inspections and every inspection that
19· · · ··we do.··And those are completely created based on
20· · · ··the administrative rules that are in effect at that
21· · · ··time.
22· ·Q· ··Do you provide that checklist to the licensees?
23· ·A· ··Yes, we do.··And it's also available on our website
24· · · ··for licensees to access at any point in time.
25· ·Q· ··And was that provided to both Viridis locations in

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·1· · · ··December of 2020?
·2· ·A· ··Yes, it was.
·3· ·Q· ··And tell me a little bit -- were you present for
·4· · · ··the semi-annual inspection?
·5· ·A· ··I was not.
·6· ·Q· ··And what was your role -- if you weren't present,
·7· · · ··what did you do?
·8· ·A· ··So my role with this and typically any inspection
·9· · · ··that is performed is just to be present as a
10· · · ··manager for oversight of my staff if there's
11· · · ··anything that, essentially, goes awry.··If there's
12· · · ··anything that they need to escalate, any
13· · · ··significant deviations from the administrative
14· · · ··rules.··If there are noncompliances with the
15· · · ··checklist that's associated with the semi-annual
16· · · ··inspection they would escalate that information to
17· · · ··me, and then I would review it and potentially
18· · · ··handle it from there depending on what was
19· · · ··happening.
20· ·Q· ··Okay.··And who performed the semi-annual inspection
21· · · ··in December of 2020?
22· ·A· ··So the semi-annual inspection in December was
23· · · ··performed by both Allyson Chirio as well as Noah
24· · · ··Rosenzweig who were both LSSs at that time.
25· ·Q· ··And did they perform them for each location?

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·1· ·A· ··I believe they did, yes.
·2· ·Q· ··Did you continue to have conversations about this
·3· · · ··is what would be needed, we need a method
·4· · · ··validation?··Were you continuing to have all of
·5· · · ··those conversations with Viridis throughout this
·6· · · ··process as well?
·7· ·A· ··Yes, I was still seeking information.
·8· · · · · · · · ··Again, it was very challenging to get
·9· · · ··information during this time because we were not
10· · · ··able to go on site as we typically would, so we
11· · · ··were having these conversations back and forth.··I
12· · · ··was requesting more information about the method,
13· · · ··more information about whether or not a validation
14· · · ··was performed.··And most of those conversations
15· · · ··were occurring with Michele Glinn and Greg and Todd
16· · · ··from the executive team.
17· · · · · · · · ··MR. RUSSELL:··Again, I'll object to the
18· · · ··foundation.··I presume that the testimony is
19· · · ··related to emails back and forth, but it's not
20· · · ··clear.··I want to make sure we have a clear record.
21· ·Q· ··(MS. HUYSER) Ms. Patterson, again, as you've
22· · · ··stated, COVID was going on, so all of your
23· · · ··communications were via email; correct?
25· ·Q· ··And you have made some reference to an in-house

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·1· · · ··study.··Was that ever provided to you?
·2· ·A· ··Yes, it was.
·3· ·Q· ··Tell me a little bit about what is an in-house
·4· · · ··study.
·5· ·A· ··Well, an in-house study doesn't necessarily mean
·6· · · ··very much.··I mean, typically I would state that an
·7· · · ··in-house study could be anything from a very small
·8· · · ··study taking a few samples, gathering some pointed
·9· · · ··results, and calling it a study, or it could
10· · · ··potentially be something more substantive than
11· · · ··that, but in this case it was not.
12· ·Q· ··I'm going to share my screen and show you what has
13· · · ··been marked as CRA's proposed Exhibit 18.··And will
14· · · ··you please let me know if you recognize what that
15· · · ··is?
16· ·A· ··Yes, I am able to see it.
17· ·Q· ··And do you recognize what that is?··And I can
18· · · ··scroll down further if you need me to.
19· ·A· ··Yes, I do recognize what this is.
20· ·Q· ··And what is it?
21· ·A· ··This is a summary of the in-house study that
22· · · ··Michele Glinn had provided to me when I asked
23· · · ··exactly what their in-house research study was.
24· · · ··And, granted, this is just the written summary of
25· · · ··that.

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·1· ·Q· ··And this -- if I went through -- did you see me go
·2· · · ··through -- and I'll go back up to the three pages
·3· · · ··that are associated with this.··Is this an accurate
·4· · · ··summary -- not -- excuse me -- an accurate
·5· · · ··depiction of what the summary is, meaning it
·6· · · ··consisted of three pages, and that's what was
·7· · · ··provided to you?
·9· · · · · · · · ··MS. HUYSER:··At this point in time I am
10· · · ··going to ask that CRA proposed Exhibit 18 be
12· · · · · · · · ··JUDGE GOLDSTEIN:··Response, Counsel?
13· · · · · · · · ··MR. RUSSELL:··No objection.
14· · · · · · · · ··JUDGE GOLDSTEIN:··CRA Exhibit 18 is
18· ·Q· ··(MS. HUYSER) Ms. Patterson, did you have a
19· · · ··chance -- obviously you read through this and you
20· · · ··did whatever scientists do and process through the
21· · · ··information, make sure that you understood it?
23· ·Q· ··Did you have an opportunity to follow up if you had
24· · · ··any additional questions to make sure that your
25· · · ··interpretations were accurate?

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·1· ·A· ··Yes, I did.
·2· ·Q· ··And did anything along this study cause you alarm
·3· · · ··or concern?
·4· ·A· ··Yes, the entire study caused me concern.
·5· ·Q· ··Walk me through.··And if you need me to scroll down
·6· · · ··or whatever you need me to do as far as being in
·7· · · ··control -- that's one of the hard parts about
·8· · · ··Zoom -- just let me know that.··But walk me through
·9· · · ··your concerns.
10· ·A· ··If you would scroll down just a little bit for me
11· · · ··that would be helpful, Sarah.··Thank you.
12· ·Q· ··Uh-huh.··Is that far enough at this point?
13· ·A· ··Yes, it is.
14· ·Q· ··Okay.
15· ·A· ··So one of the things noted here is the analyst
16· · · ··would mix the sample as much as possible with a
17· · · ··disposable spatula scraping the sides and bottom
18· · · ··and then take 0.5 to 1 gram.··So, again, I want to
19· · · ··note that there's a bit of a deviation here.
20· · · · · · · · ··So the method that was submitted stated
21· · · ··that they will scrape the sides, the bottom, the
22· · · ··top, as well as the coated grinding media.··So this
23· · · ··is, again, different from that.
24· · · · · · · · ··And then they also stated that they would
25· · · ··take this time 0.5 to 1 gram, whereas I believe

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·1· · · ··previously it was 0.4 to 1.2 grams, which, again,
·2· · · ··is just showing me that there is inconsistency in
·3· · · ··how this method is being performed and
·4· · · ··inconsistency from the method that was actually
·5· · · ··approved.
·6· · · · · · · · ··So for me overseeing, you know,
·7· · · ··laboratories in the regulatory space the fact that
·8· · · ··there is so much deviation, even though it seems
·9· · · ··minimal, tells me that they're probably not
10· · · ··performing this method in compliance with what was
11· · · ··approved or consistently in the laboratory space.
12· · · · · · · · ··And you can scroll to the next page,
13· · · ··Sarah.··Sorry.
14· ·Q· ··Nope.··Thank you.
15· · · · · · · · ··Okay.··Is that far enough, or would you
16· · · ··like me to go more?
17· ·A· ··No, this is perfect.··Thank you.
18· ·Q· ··Uh-huh.
19· ·A· ··So I found this piece here that's highlighted
20· · · ··interesting.··"The influence of which part of the
21· · · ··sample was selected from the jar was reviewed.
22· · · ··There was extensive discussion about which part was
23· · · ··most representative as well as the most important
24· · · ··to test in terms of public safety."
25· · · · · · · · ··And so, again, I want to reiterate that

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·1· · · ··we should be testing whatever it is that the
·2· · · ··consumer is going to be using, which would be the
·3· · · ··entirety of the flower sample.
·4· ·Q· ··Okay.
·5· ·A· ··And then again here noting -- and this is an
·6· · · ··important distinction for me to make -- but here it
·7· · · ··notes that "De-stemming procedures were formalized
·8· · · ··and staff instructed to remove all stem pieces, not
·9· · · ··just large ones."
10· · · · · · · · ··So before I stated yes, of course, it is
11· · · ··important to move those large stem pieces, and
12· · · ··that's completely relevant; however, there are
13· · · ··going to be little tiny pieces of the stem that are
14· · · ··attached to the flower parts.··You can kind of
15· · · ··think of those as, you know, you have a lily,
16· · · ··essentially, and it's got multiple heads on it.··So
17· · · ··those are rather big.··But in the case of the
18· · · ··cannabis flower they're going to be little teeny
19· · · ··stems that come off.··And typically we didn't
20· · · ··recommend that they de-stem that portion of it
21· · · ··because it's going to be something that a consumer
22· · · ··would not typically do.
23· · · · · · · · ··And this part was of great concern to me.
24· · · ··So this notes that "The plant material on the
25· · · ··ceramic grinding balls was thought to be the most

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·1· · · ··representative selection of the sample."
·2· · · · · · · · ··So this is what we would call a
·3· · · ··hypothesis.··And this right here in and of itself
·4· · · ··would warrant performing a validation on this
·5· · · ··study.··Because we can't just make these assertions
·6· · · ··and say, well, we think that this is going to be
·7· · · ··the most representative, we have to actually test
·8· · · ··in practice rigorously whether or not that is true.
·9· · · · · · · · ··And some of the concerns that I had in
10· · · ··particular, without having tested it myself, was
11· · · ··the fact that cannabis trichomes are very sticky.
12· · · · · · · · ··So I mentioned before those trichomes are
13· · · ··these hair-like glandular structures, and they have
14· · · ··these big bulbous tops on them that are filled with
15· · · ··cannabis resin which contains the cannabinoids and
16· · · ··all the terpenes.
17· · · · · · · · ··Now, that stuff is very, very sticky.
18· · · ··And when a, you know, any sort of grinding media, a
19· · · ··ceramic grinding ball, for example, is moved very
20· · · ··quickly at high speeds and high temperatures
21· · · ··throughout the plant material it's going to
22· · · ··essentially glom onto that resinous material
23· · · ··because the resin is very sticky.··And, of course,
24· · · ··there's probably plant material that's stuck on
25· · · ··there as well because the resin is sticky.··But

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·1· · · ··there's no real way to determine how much of that
·2· · · ··material is getting stuck on there without
·3· · · ··performing a validation to essentially ensure that
·4· · · ··it's consistent, you know, what the appropriate
·5· · · ··ratio of it is to the amount of sample ground.··So,
·6· · · ··like I said, it's really just a hypothesis.··And my
·7· · · ··concern was that this wasn't accompanied by a
·8· · · ··validation study as we would require.
·9· ·Q· ··What is a cannabinoid?
10· ·A· ··A cannabinoid is essentially a molecule that's
11· · · ··going to be something like THC or CBD.··Those are
12· · · ··the ones that we commonly hear of.··And those are
13· · · ··the things that are -- the molecules within the
14· · · ··plant that are going to, well, potentially get you
15· · · ··high.··You know, work to ease pain.··Obviously, the
16· · · ··studies are a little bit limited in that space, but
17· · · ··ultimately they produce some sort of effect in the
18· · · ··body.
19· ·Q· ··And what is a terpene?
20· ·A· ··A terpene is a flavor or a smell profile that
21· · · ··essentially gives the cannabis its taste and it's
22· · · ··scent.··And they work in concert with the
23· · · ··cannabinoids to essentially provide some sort of
24· · · ··purportedly medical -- medical feelings whether
25· · · ··that's relief of anxiety or pain relief or just

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·1· · · ··generally the high that you're going to feel from
·2· · · ··the material itself and the use of that material.
·3· ·Q· ··So from this summary of the in-house study could
·4· · · ··you tell how many samples were studied or how many
·5· · · ··different experiments or -- could you tell the
·6· · · ··actual medium and the process?
·7· ·A· ··No, I could not.
·8· ·Q· ··So here we are.··We're coming on chronologically
·9· · · ··the end of December after there's a semi-annual
10· · · ··inspection.··Where are we going next?··What happens
11· · · ··throughout the process?
12· ·A· ··So throughout the course of this process, to be
13· · · ··honest with you, we're still trying to figure out
14· · · ··exactly what's going on, if there has been a
15· · · ··validation study that's been performed, because at
16· · · ··this point once we received the summary that you
17· · · ··just showed me it was apparent that there had been
18· · · ··substantive changes to the SOP.··We had no evidence
19· · · ··that those had been validated.
20· · · · · · · · ··We also were trying to determine if there
21· · · ··were any other changes that weren't being reported
22· · · ··to us.··And we were trying to figure out exactly
23· · · ··what those things were so that we could determine
24· · · ··what SOP was being used in the lab space and
25· · · ··hopefully get the laboratory back on track with

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·1· · · ··being in compliance with our SOPs.
·2· ·Q· ··Have you told them?··Are they aware that they're
·3· · · ··not in compliance with their SOPs?
·4· ·A· ··I told them very early on, I believe it was in
·5· · · ··early November of 2019, that I had concerns that
·6· · · ··what they were doing in the laboratory space was
·7· · · ··not in compliance with our SOPs.··And that started
·8· · · ··with the conversation about the use of the word
·9· · · ··"approximate" as it related to 1 gram and the
10· · · ··verification that they actually performed.
11· ·Q· ··So if we were to stop and push pause at the end of
12· · · ··20- -- at the end of 2020 as we're getting through
13· · · ··this, how many variations of an operating procedure
14· · · ··have you seen regarding potency for flower?
15· ·A· ··So at the end of 2020 we had really seen two
16· · · ··primary SOPs, the one that was approved and then
17· · · ··this November/December SOP that had gone back and
18· · · ··forth.··But we also saw them allude to potentially
19· · · ··another SOP in that research study summary that you
20· · · ··just showed me.··Because, again, the weight in
21· · · ··there changed from what was purported in the
22· · · ··November slash December SOP.
23· ·Q· ··And if we're to stop again at the end of December
24· · · ··2020, what SOP is approved per CRA records?
25· ·A· ··The May of 2020 SOP.

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·1· ·Q· ··At this point in time had you received anything or
·2· · · ··enough documents for there to be an official method
·3· · · ··review conducted?
·4· ·A· ··No, I had not.
·5· ·Q· ··Now, is it possible that a semi-annual inspection
·6· · · ··can be passed if you're using an unapproved method?
·7· ·A· ··Yes.··Unfortunately at that point in time I believe
·8· · · ··what the semi-annual inspection required was that
·9· · · ··it simply -- or that the laboratory simply had an
10· · · ··SOP and it was on file and that it was approved.
11· · · ··Now, that didn't necessarily correlate to whether
12· · · ··they were using the approved SOP, just whether or
13· · · ··not they had one.
14· ·Q· ··You know, that doesn't make a lot of sense to me.
15· · · ··Explain to me how that came about where they just
16· · · ··had to have one that was approved?
17· ·A· ··I agree.··It doesn't make a lot of sense to me
18· · · ··either.··It was, unfortunately, the way that the
19· · · ··administrative rules were written at that time.··I
20· · · ··believe it was a bit vague.··And ultimately we
21· · · ··determined that it was not defensible.··That they
22· · · ··had to specifically be following the SOP, therefore
23· · · ··it would not have been appropriate to mark that as
24· · · ··deficient on the semi-annual inspection.
25· ·Q· ··Is it noted on semi-annual inspections when someone

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·1· · · ··is not following their SOP --
·2· ·A· ··Yes.
·3· ·Q· ··-- and still passed?
·4· ·A· ··Yes.··There may be notes related to someone not
·5· · · ··following an SOP or other concerns that we may have
·6· · · ··with the laboratory that were observed during this
·7· · · ··semi-annual inspection and the audit portion in
·8· · · ··particular just to essentially notify the
·9· · · ··laboratory that, you know, you may have passed the
10· · · ··semi-annual inspection but we still have concerns,
11· · · ··and these are what those concerns are.
12· ·Q· ··So from December of 2020 and into 2021 what was
13· · · ··happening as far as trying to rectify the problem
14· · · ··of not acting in accordance with an SOP?
15· ·A· ··So at that point in time we were still trying to
16· · · ··gather information and the appropriate validation
17· · · ··for the changes that had been made to the May 2020
18· · · ··SOP.··So there was still email communications that
19· · · ··were going back and forth trying to figure out
20· · · ··exactly what it was that the laboratory was doing.
21· · · · · · · · ··And I will reiterate it was incredibly
22· · · ··challenging doing this through a virtual
23· · · ··environment as, you know, typically we would go on
24· · · ··site with the laboratory and have them walk us
25· · · ··through their procedure so that we could have a

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·1· · · ··better eye on what was going on in real time in
·2· · · ··that space.
·3· ·Q· ··The CRA has a process where they go through
·4· · · ··investigations or create complaints?
·6· ·Q· ··And was that process -- did that start in 2021?
·7· ·A· ··In early 2021 because of the deviations that were
·8· · · ··noted during the audit portion of the semi-annual
·9· · · ··inspection, yes, an investigation was started
10· · · ··specifically regarding the method deviations from
11· · · ··the May 2020 SOP.
12· ·Q· ··And tell me why.··You mentioned because of the
13· · · ··defects, but tell me what is your thought process
14· · · ··in starting an investigation.
15· ·A· ··So at that point in time we had witnessed Michael
16· · · ··LaFramboise on camera actually physically
17· · · ··performing the SOP in a way that was not in
18· · · ··conformance with the SOP that we had on file.··And
19· · · ··that was specifically because he was scraping those
20· · · ··grinding media or the grinding balls and using that
21· · · ··scraped-off resinous plant material and putting it
22· · · ··back into the homogenized flower in attempts to
23· · · ··rehomogenize it for then later sampling.
24· · · · · · · · ··So once we had witnessed that we knew for
25· · · ··a fact that they were not following the May 2020

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·1· · · ··SOP, and that was enough to warrant beginning an
·2· · · ··investigation.
·3· ·Q· ··And Michael LaFramboise is a new name for our ALJ,
·4· · · ··so please tell me who he is.
·5· · · · · · · · ··MR. RUSSELL:··Before you -- I'd like to
·6· · · ··place an objection on the record again to lack of
·7· · · ··foundation.··There was just testimony about Michael
·8· · · ··LaFramboise conducting a potency sample testing
·9· · · ··that was reviewed by the CRA but there's no context
10· · · ··whether this related back to the December 22, 2020,
11· · · ··semi-annual inspection, which I believe it did.··So
12· · · ··you could at least clarify that?
13· · · · · · · · ··MS. HUYSER:··Which was what I was going
14· · · ··to do by asking who he was, where he was, and where
15· · · ··they saw it.
16· · · · · · · · ··So please, if -- may she continue, Your
17· · · ··Honor?
18· · · · · · · · ··JUDGE GOLDSTEIN:··With that clarification
19· · · ··Counsel, may counsel continue with those questions?
20· · · ··Mr. Russell?
21· · · · · · · · ··MR. RUSSELL:··Yeah.··Thank you, Your
22· · · ··Honor.··I just wanted to make sure it was clear,
23· · · ··because it seemed like the witness was testifying
24· · · ··to some other time they reviewed it which I don't
25· · · ··believe was the case.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··I understand.··Yeah.
·2· · · · · · · · ··Go ahead, develop the foundation a little
·3· · · ··bit more.
·5· ·Q· ··(MS. HUYSER) And, Ms. Patterson, who is Michael
·6· · · ··LaFramboise?
·7· ·A· ··He's a laboratory manager at the Viridis North
·8· · · ··Bay City location.
·9· ·Q· ··And, again, you mentioned that you -- that you guys
10· · · ··had seen him perform this test.··When was that?
11· ·A· ··So Allyson Chirio and Noah Rosenzweig witnessed him
12· · · ··performing this test during the audit portion of
13· · · ··the semi-annual inspection I believe it was
14· · · ··December 22nd of 2020.
15· ·Q· ··Okay.··And that was, again, the one you were
16· · · ··discussing previously in your testimony that was
17· · · ··virtual that they had observed?
19· ·Q· ··So an investigation was started.··What was the
20· · · ··process for investigations?
21· ·A· ··Generally speaking, the process for investigations
22· · · ··is we receive some sort of a complaint or we
23· · · ··identify some sort of a noncompliance with the
24· · · ··administrative rules.··We file a complaint or file
25· · · ··a complaint on behalf of the complainant within our

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·1· · · ··Accela system, and then from there we go on to
·2· · · ··investigate it further.
·3· · · · · · · · ··There may be, you know, any number of
·4· · · ··communications back and forth through any number of
·5· · · ··means.··Email, phone call, on-site, etc.··We
·6· · · ··collect evidence.··We collect interview
·7· · · ··information.··And then we compose that information,
·8· · · ··all of it together, into an investigative report.
·9· · · ··That then goes to the manager for review.
10· · · · · · · · ··The manager reviews it and then sends it
11· · · ··on either to our legal section or ultimately to the
12· · · ··office of the attorneys general as is warranted,
13· · · ··depending on the pathway.
14· ·Q· ··So as this process is going on and the
15· · · ··investigation is going on are you continuing to
16· · · ··move forward through your typical functions that
17· · · ··you would go through with a lab?
18· ·A· ··Yes, of course.
19· ·Q· ··Okay.··Was Viridis allowed to test during this
20· · · ··process?
21· ·A· ··Viridis was allowed to continue testing during this
22· · · ··process, yes.
23· ·Q· ··And there was another semi-annual inspection in
24· · · ··June of 2021; correct?

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·1· ·Q· ··Okay.··And please tell me, when did that take
·2· · · ··place?··Was it virtual?··Who was doing it?
·3· ·A· ··So it was in June -- I believe it was June 9th of
·4· · · ··2021.··And it was actually just after some COVID
·5· · · ··restrictions were released a little bit for the
·6· · · ··Agency.··So we were permitted to go on site to
·7· · · ··Viridis Lansing to perform this semi-annual
·8· · · ··inspection.··And this one also included an audit
·9· · · ··portion much like the virtual one that occurred in
10· · · ··December of 2020.
11· ·Q· ··And were you present for that?
12· ·A· ··I was present for this one, yes.
13· ·Q· ··And so did it occur in both Viridis locations or --
14· · · ··sorry if I missed -- didn't hear that.
15· ·A· ··I apologize.··So this one occurred at the Viridis
16· · · ··Lansing location physically and at that June 9,
17· · · ··2021, inspection and audit.
18· ·Q· ··Tell me what happened.··You said you guys usually
19· · · ··get in, you talk, but walk me through this process,
20· · · ··please.
21· ·A· ··So that day was a little bit different.··We showed
22· · · ··up on site.··We let them know that we were there.
23· · · ··And I believe that the desk staff by way of Michele
24· · · ··Glinn had told us that they were not available to
25· · · ··actually meet with us at that point in time.··They

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·1· · · ··had stated that they were in interviews and they
·2· · · ··wouldn't be able to assist us.··And so we
·3· · · ··essentially pressed and said, well, you know, you
·4· · · ··need to let us in.··We're going to conduct this
·5· · · ··inspection and audit.··We really only need your
·6· · · ··techs to be present to do that portion.··And then
·7· · · ··at that point in time they did allow us to come in.
·8· · · · · · · · ··So during that point in time we went into
·9· · · ··the laboratory space, kind of set the stage very
10· · · ··briefly and said, hey, we're here, we're going to
11· · · ··do the semi-annual inspection, and in particular we
12· · · ··want to look at your potency method.
13· · · · · · · · ··And as you'll recall, I've stated
14· · · ··multiple times, we needed to be in the laboratory
15· · · ··space to see what was really going on with this
16· · · ··method to help us better understand where or if
17· · · ··there was some sort of a disconnect between us and
18· · · ··the laboratory themselves.
19· ·Q· ··When you say "we" who was with you?
20· ·A· ··I apologize.··That was myself and Noah Rosenzweig.
21· ·Q· ··So you went in.··You were allowed to see -- did you
22· · · ··just look at potency?··Did you look at anything
23· · · ··else?··Walk me through your process.
24· ·A· ··No.··So we were really there to focus on the
25· · · ··potency, and then the semi-annual audit portion or

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·1· · · ··the semi-annual inspection portion was completed as
·2· · · ··well.··But in terms of the audit, it was focused
·3· · · ··solely on potency.
·4· · · · · · · · ··And at that point in time Noah worked
·5· · · ··with David Fristik who was the laboratory manager
·6· · · ··at the Viridis Lansing location.··And during that
·7· · · ··time I was also speaking with Michele Glinn just
·8· · · ··talking with her about the communications that we
·9· · · ··had had back and forth regarding the method while
10· · · ··Noah did his inspection and audit portion.
11· ·Q· ··So you didn't observe the testing at that point in
12· · · ··time, Noah did?
14· ·Q· ··Were there anything about anything else that you
15· · · ··may have observed at the lab during June that
16· · · ··caused you alarm or caused you concern?··What was
17· · · ··the conditions of the lab?
18· ·A· ··So the laboratory appeared to be as it normally is,
19· · · ··relatively clean and in functional order it would
20· · · ··seem.··My only concern in my conversations with
21· · · ··Michele Glinn was that she kept saying that they
22· · · ··had performed a research study on this change to
23· · · ··the SOP.··And there were a couple of items that I
24· · · ··brought out, specifically the amount of resin and
25· · · ··plant material that was on those grinding media.

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·1· · · ··And I had asked her if she had performed what we
·2· · · ··would call just a test of those.··So to -- you
·3· · · ··know, instead of including those grinding media and
·4· · · ··the plant material in a sample for extraction, if
·5· · · ··she had just looked at how much THC is on one of
·6· · · ··those grinding media.
·7· · · · · · · · ··And I asked her if she had done a
·8· · · ··validation on it and she said, "No, well, yeah,
·9· · · ··we've done a research study."··Which to me alluded
10· · · ··back to what they had done.··But, you know, I
11· · · ··continued to ask more questions to talk about the
12· · · ··process, what the hypotheses were.
13· · · · · · · · ··But additionally when we finished up Noah
14· · · ··brought me some concerns that he had had and
15· · · ··observed while he was watching David Fristik
16· · · ··perform the method.
17· ·Q· ··And did you discuss those with Dr. Glinn while you
18· · · ··were there?
19· ·A· ··I did not discuss them with Dr. Glinn while I was
20· · · ··there.··We did not discuss until we got back I
21· · · ··believe into the office officially.
22· ·Q· ··So were you -- did you end up having any further
23· · · ··communication about, okay, what method are you
24· · · ··using here, what happened, what was David Fristik
25· · · ··doing with Viridis itself?

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·1· ·A· ··Yes.··So I specifically followed up the day after,
·2· · · ··I believe it would have been June 10th of 2021,
·3· · · ··after my conversation with Michele and let her know
·4· · · ··that I needed to see this updated SOP.··I wanted to
·5· · · ··see the validation study or any of those other
·6· · · ··research studies that she was referring to at that
·7· · · ··point in time.··I believe that I had requested any
·8· · · ··associated data just so I could see it again in
·9· · · ··hopes that there would be additional information
10· · · ··there.
11· ·Q· ··Was anything provided to you?
12· ·A· ··She provided me a number of attachments I believe.
13· · · ··I think that there was the November -- or excuse
14· · · ··me -- December SOP as well as -- some of the
15· · · ··documents I believe I had seen before, part of the
16· · · ··research study, without any significant changes to
17· · · ··it as far as I was aware.
18· ·Q· ··Okay.··I'm going to put on screen what has been
19· · · ··marked as CRA's proposed Exhibit 3, and I'm going
20· · · ··to ask that you tell me if you recognize what this
21· · · ··document is.
22· · · · · · · · ··Can you see that?
23· ·A· ··Yes, I can.
24· ·Q· ··Okay.··I'm going to scroll down.
25· · · · · · · · ··And can you tell me what this appears to

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·1· · · ··be?
·2· ·A· ··This appears to be an SOP from Viridis.··I am not
·3· · · ··quite able to tell which one yet.
·4· ·Q· ··Okay.··I will go down further if that will help you
·5· · · ··out.
·6· ·A· ··Thank you.··It would.
·7· · · · · · · · ··I do recognize this.··This would actually
·8· · · ··be the June 25th SOP that was provided to my team
·9· · · ··here at the CRA by Viridis.··And this actually
10· · · ··differs from I believe the SOP that was provided on
11· · · ··June 10th.
12· ·Q· ··And I'm going to ask you a weird question, but as
13· · · ··you read through these how are you understanding or
14· · · ··recalling which was submitted when?
15· ·A· ··I'm recalling how they're submitted because it was
16· · · ··almost a -- it was an addition over time I think is
17· · · ··the best way that I can put that.··So the method
18· · · ··that we had in May of 2020 was relatively basic.
19· · · ··It included homogenization.··It had a very clear
20· · · ··1 gram prep weight.··And then it became more
21· · · ··complex once we started to get the December or the
22· · · ··early June method, you know, that the prep range
23· · · ··expanded quite a bit.··We saw that they had scraped
24· · · ··the sample from the sides and the top as well as
25· · · ··the ceramic grinding media, so that was another

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·1· · · ··addition.
·2· · · · · · · · ··And then on this version what we see is
·3· · · ··that two of the ceramic grinding balls are removed
·4· · · ··now from the amber jar and weighed.··The balls
·5· · · ··should be completed coated in plant residue.··The
·6· · · ··balls themselves are placed -- excuse me -- placed
·7· · · ··in a conical screw cap vial with an additional 0.2
·8· · · ··to 0.5 grams of remaining flower.
·9· · · · · · · · ··So at this point they've added a step
10· · · ··where they're actually taking those ceramic
11· · · ··grinding media, and instead of scraping the
12· · · ··material back into the flower material for
13· · · ··attempted homogenization they actually just dropped
14· · · ··those grinding media right into the extraction vial
15· · · ··and then add what should be homogeneous plant
16· · · ··material on top of that as well.··And ultimately
17· · · ··I'm not even sure if that adds up to the 1 gram we
18· · · ··had talked about in the beginning.
19· ·Q· ··I'm going to scroll to the bottom just to make sure
20· · · ··that this is the end.
21· · · · · · · · ··Does this accurately reflect what was
22· · · ··provided to you you indicated on June 21st of 2021
23· · · ··or around -- on or about that date?
24· ·A· ··I believe it was the June 25th.··But yes, that is
25· · · ··an accurate depiction.

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·1· ·Q· ··Okay.··No changes or alterations to that?
·2· ·A· ··That is correct.
·3· · · · · · · · ··MS. HUYSER:··At this point in time I
·4· · · ··would ask that CRA proposed Exhibit 3 be admitted,
·5· · · ··Your Honor.
·7· · · · · · · · ··MR. RUSSELL:··No objection, Your Honor.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you.··CRA Exhibit
·9· · · ··3 is admitted.
11· · · · · · · · ··JUDGE GOLDSTEIN:··Does anybody need a
12· · · ··break at this point?
13· · · · · · · · ··MR. RUSSELL:··Yes, Your Honor.··If we
14· · · ··could take a 15-minute break that would be great.
15· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··It's 2:05.
16· · · ··We'll reconvene at 2:20.··Okay?
17· · · · · · · · ··MS. HUNT-SCULLY:··Thank you, Your Honor.
20· · · · · · · · ··(Break taken at 2:05 PM)
22· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··We're back
23· · · ··on the record in the matter of Viridis
24· · · ··Laboratories, LLC, and Viridis North, LLC, versus
25· · · ··Cannabis Regulatory Agency, consolidated Docket

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·1· · · ··Numbers 21-02 -- hmm.··Wait a minute here.··Let me
·2· · · ··check something.··Order's not -- okay.··029794,
·3· · · ··et al.
·4· · · · · · · · ··All right.··When we left off here we were
·5· · · ··continuing with the examination of Ms. Patterson.
·6· · · · · · · · ··Ms. Huyser, go ahead.
·8· ·Q· ··(MS. HUYSER) So, Ms. Patterson, we just had
·9· · · ··discussed the fact that there was a June 25th of
10· · · ··2021 description of an SOP provided to you by
11· · · ··Viridis.
12· · · · · · · · ··What did you do with that document?
13· ·A· ··So that document was a document that we had been
14· · · ··hoping that they would submit to us for quite some
15· · · ··period of time.··So once we finally received that
16· · · ··document and we had seen, obviously in person, that
17· · · ··they were following this June of 2021 SOP we did
18· · · ··move to issue them a formal denial of the use of
19· · · ··that method despite the fact that it was not
20· · · ··necessarily submitted to us through the normal, you
21· · · ··know, routes and procedures.··It did not have a
22· · · ··proficiency test with it.··Didn't have the
23· · · ··appropriate validation.··Didn't have the
24· · · ··appropriate data packages.
25· · · · · · · · ··But at that point in time, because we had

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·1· · · ··spent the better part of seven months going back
·2· · · ··and forth with them trying to figure out what was
·3· · · ··going on and what was deviating in the method we
·4· · · ··thought that it was prudent to issue them an
·5· · · ··official denial and let them know that they were
·6· · · ··not permitted to use this method.
·7· ·Q· ··Why didn't you do that a month in, or two months
·8· · · ··in, or three?
·9· ·A· ··The reason that we didn't do that a month in or two
10· · · ··months in or three months in is because there was
11· · · ··actually a lot of confusion internally at the CRA
12· · · ··about what method they were still using.··Based on
13· · · ··the data that we had been given, the limited data
14· · · ··that we had been given, the explanations that we
15· · · ··had received, we had a sense that the SOP that they
16· · · ··had provided in December of 2020 was not what they
17· · · ··were actually doing in the laboratory space, and we
18· · · ··needed to gather more information to actually
19· · · ··determine what it was that was going on in the
21· ·Q· ··And the June 2020 semi-annual inspection, was that
22· · · ··pass or fail?
23· ·A· ··The June 2020 semi -- or 2021 semi-annual
24· · · ··inspection was passed.
25· ·Q· ··And why is that if you didn't believe that they

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·1· · · ··were acting in conformity with the SOP on file?
·2· ·A· ··As I said previously, the way that the
·3· · · ··administrative rules were written at that time and
·4· · · ··therefore the corresponding semi-annual inspection
·5· · · ··checklist was written, we didn't believe that it
·6· · · ··was defensible in order for us to fail them just
·7· · · ··based on the language of the rule.··So because of
·8· · · ··the audit that occurred concurrently, we decided to
·9· · · ··take the investigative route to follow up on this
10· · · ··deviation.
11· ·Q· ··And is that because what you said, the checklist --
12· · · ··and I want to make sure I'm understanding
13· · · ··correctly -- only required that they have an
14· · · ··approved one on file?
16· ·Q· ··And, again, at the end of June of 2021 what did the
17· · · ··CRA believe to be the approved potency method on
18· · · ··file?
19· ·A· ··The method that was approved in May of 2020.
20· ·Q· ··As we sit here in May of 2023 what is the approved
21· · · ··method on file for potency for both Viridis
22· · · ··locations?
23· ·A· ··May of 2020.
24· ·Q· ··Has there been anything, a complete validation
25· · · ··request with all of the proficiency tests, data

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·1· · · ··packets, studies, and validations submitted to the
·2· · · ··CRA asking for the method to be approved?
·3· ·A· ··There has not.
·4· ·Q· ··So no method approval has been sought even in 2022?
·6· ·Q· ··And, obviously, being halfway through 2023, still
·7· · · ··nothing yet?
·9· ·Q· ··So as I look and go through, I have a couple more
10· · · ··questions generally about potency.
11· · · · · · · · ··So at this point is there a set of ISO or
12· · · ··IEC standards that have to be approved of and
13· · · ··followed for standard operating procedures?
14· ·A· ··There are, specifically as it relates to document
15· · · ··control in particular.
16· ·Q· ··For potency?
17· ·A· ··Not for potency in specific, no.
18· ·Q· ··Okay.··And for your potency you have to have -- be
19· · · ··following the approved method on file; correct?
21· ·Q· ··And -- all right.··Sorry.··I'll strike that.
22· · · · · · · · ··All right.··So as we start to move
23· · · ··forward in time, we're coming out of June of 2021.
24· · · ··Eventually there was an on-site audit or inspection
25· · · ··that's done in October of 2021; correct?

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·2· ·Q· ··What precipitates that?··What brings it on?
·3· ·A· ··So what brings that on essentially are a series of
·4· · · ··complaints and data anomalies that we observed from
·5· · · ··both Viridis North and Viridis Lansing locations.
·6· ·Q· ··Such as?··Can you give me some examples?
·7· ·A· ··I can.··So initially one of the complaints that we
·8· · · ··had received I believe it was early September of
·9· · · ··2021, another laboratory had alleged that a client
10· · · ··came to them and said, you know, if they wanted to
11· · · ··pass microbials, that they would go to Viridis.
12· · · ··Granted, that could be an idle complaint, but it's
13· · · ··a complaint made to the Agency.
14· · · · · · · · ··So given Viridis's history in not
15· · · ··following their standard operating procedures, that
16· · · ··did raise some concerns and some what I would
17· · · ··consider to be yellow flags.
18· · · · · · · · ··And so from there we certainly paid
19· · · ··attention to the data that was coming through.··And
20· · · ··at that point in time we still were reviewing all
21· · · ··of the data that came through Metrc per our normal
22· · · ··procedures, but we also were reviewing and actually
23· · · ··do still review Metrc tickets.··And Metrc tickets
24· · · ··are essentially requests for approval that come
25· · · ··from our statewide monitoring system when a testing

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·1· · · ··status needs to be updated for some reason or
·2· · · ··another.
·3· · · · · · · · ··So when that happens, what that causes us
·4· · · ··to do is we get into Metrc, which is, as I said,
·5· · · ··our statewide monitoring system, and we trace those
·6· · · ··packages back over time.··We look at their history.
·7· · · ··We look at their testing.··Very frequently we reach
·8· · · ··out to the laboratory.··We often reach out to the
·9· · · ··other licensee involved, either a cultivator or a
10· · · ··processor, just to help understand on our side
11· · · ··what's going on with those packages and the testing
12· · · ··status updates that they're requesting.
13· ·Q· ··I'm going to unpack that a little bit.
14· · · · · · · · ··So you mentioned that Metrc is the
15· · · ··statewide tracking system.
17· ·Q· ··Explain to me how that works, and explain to the
18· · · ··Court how that works.
19· ·A· ··So in Michigan we use the statewide monitoring
20· · · ··system, the official name of that is Metrc, to
21· · · ··track essentially every package in our regulated
22· · · ··market.··So it tracks where a package is born.··It
23· · · ··tracks how it is made.··It tracks where it moves to
24· · · ··throughout the supply chain.··It tracks where it's
25· · · ··been tested.··And it also includes all of the

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·1· · · ··testing results that are associated with that
·2· · · ··package whether it's tested 1 time or 100 times.
·3· ·Q· ··And by package you mean something with a tag that
·4· · · ··could be flower or whatever form it's in?
·5· ·A· ··Yes.··That could be a package of marijuana flower,
·6· · · ··marijuana concentrate, infused products.··Any sort
·7· · · ··of marijuana product that you could, as a consumer,
·8· · · ··purchase in its end state.
·9· ·Q· ··And what is a cultivator?
10· ·A· ··A cultivator is a marijuana grower.··An
11· · · ··individual -- or excuse me -- rather an entity
12· · · ··licensed in the state of Michigan to grow and
13· · · ··cultivate marijuana plants.
14· ·Q· ··And a processor?
15· ·A· ··Is an entity that is approved and licensed to
16· · · ··process marijuana plants.··So that may mean in our
17· · · ··state that they are packaging them, that they're
18· · · ··turning them into marijuana concentrate,
19· · · ··marijuana-infused products, marijuana topical
20· · · ··products.··Essentially anything that is not
21· · · ··marijuana flower.
22· ·Q· ··And when does testing happen, at what point?
23· ·A· ··So testing can technically occur at any point.
24· · · ··That is essentially based on what the business
25· · · ··owner wants to do in terms of testing.··But at the

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·1· · · ··end of the day testing is required in the final
·2· · · ··state which means the form that the product is in
·3· · · ··before it goes to the retail market for a consumer
·4· · · ··to purchase.
·5· ·Q· ··So if something is staying marijuana flower, then
·6· · · ··it gets tested in that state?
·8· ·Q· ··When you talk about testing, obviously we've talked
·9· · · ··about potency.··We don't need to talk about that.
10· · · ··But what other forms of testing exist?
11· ·A· ··So it depends on the type of product that you're
12· · · ··talking about, but, broadly speaking, there is
13· · · ··microbial testing.··So under that we have testing
14· · · ··for E. coli, salmonella, and coliforms which are
15· · · ··all types of bacteria.··We have testing for total
16· · · ··yeast and mold which, as it sounds, is yeasts and
17· · · ··molds.··And we have testing for aspergillus, which
18· · · ··is a type of mold or fungi.··We have testing for
19· · · ··pesticides or chemical residues, testing for
20· · · ··residual solvents, testing for heavy metals, water
21· · · ··activity, as well as foreign matter.··And potency,
22· · · ··as you mentioned.
23· ·Q· ··Is Viridis collectively, are they approved to test
24· · · ··for all of these things?
25· ·A· ··Yes, they are.

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·1· ·Q· ··So that would be then state that they have standard
·2· · · ··operating procedures in place for microbial
·3· · · ··testing, total yeast and mold, every one of those
·4· · · ··things that you've mentioned?
·6· ·Q· ··Okay.··And at that point they've all been approved
·7· · · ··by the CRA?
·9· ·Q· ··So, again, you mentioned that you were looking
10· · · ··through Metrc and you saw some discrepancies or
11· · · ··some things, plus you had the complaint.··That's
12· · · ··what caused the October 2021 on-site inspection?
13· ·A· ··Yes.··So at that point in time we had had a
14· · · ··couple -- I believe it was two packages come across
15· · · ··to us through Metrc tickets that had originally
16· · · ··failed for the presence of aspergillus.··And,
17· · · ··again, that's a mold.··And it had gone to a Viridis
18· · · ··laboratory for retesting and it had passed.
19· · · · · · · · ··So we had reached out to the cultivator
20· · · ··and asked them if they had performed any sort of
21· · · ··remediation technique.··And remediation is what's
22· · · ··done, particularly in the case of microbials, to
23· · · ··kill or get rid of those microbials through various
24· · · ··means, like treatment with ozone or treatment with
25· · · ··UV light that would kill those fungi and then allow

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·1· · · ··the sample, then, to pass into the -- into the
·2· · · ··regulated market, assuming it passes for everything
·3· · · ··else.
·4· ·Q· ··And had any remedial measures been taken?
·5· ·A· ··They had not.
·6· ·Q· ··What did that cause you to do?
·7· ·A· ··This caused us to look further at the data and see
·8· · · ··if there was any anomalies with the amount or
·9· · · ··percentage of failures that we were seeing from
10· · · ··either of the Viridis laboratories, Viridis Lansing
11· · · ··or Viridis North, to see if they were reporting
12· · · ··aspergillus failures approximately the same as
13· · · ··other laboratories.
14· · · · · · · · ··And I'll go to the scientific perspective
15· · · ··here a little bit.··But typically we expect to see
16· · · ··failures on essentially a bell curve.··You know,
17· · · ··there may be some variation between here and there
18· · · ··between how the laboratories report on a day-to-day
19· · · ··basis, but overall we expect that the average is
20· · · ··going to fall in the middle of the bell curve, and
21· · · ··that those failures will be approximately the same
22· · · ··amount.
23· ·Q· ··And what did you find?
24· ·A· ··So we found that Viridis Lansing was reporting
25· · · ··aspergillus failures approximately 80 percent, I

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·1· · · ··believe, 89 percent less than other laboratories.
·2· · · ··And then Viridis North was reporting aspergillus
·3· · · ··failures 40 percent less than other laboratories.
·4· · · ··And that would be an average for all other
·5· · · ··laboratories combined I want to clarify.
·6· ·Q· ··And, obviously -- I want to make sure that I'm
·7· · · ··understanding.··That's those -- all laboratories
·8· · · ··that are under the CRA regulation?
·9· ·A· ··That is correct.··Thank you.
10· ·Q· ··In the state of Michigan?
12· ·Q· ··So anything else factor into the decision to do the
13· · · ··October on-site audit?
14· ·A· ··Yes.··So once we had gotten these Metrc tickets we
15· · · ··had assessed the data, we had gotten this
16· · · ··complaint, we reached out and asked the laboratory
17· · · ··to provide us some more information.··In particular
18· · · ··I recall that we asked for incubator logs, which
19· · · ··would be time and temperature controls for the
20· · · ··samples.
21· · · · · · · · ··And in particular I believe it was Craig
22· · · ··Luna, and I can't recall which laboratory he in
23· · · ··particular works at, but he responded to us and let
24· · · ··us know that they do not keep time in and time out
25· · · ··logs for the incubator that would allow them to

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·1· · · ··verify that they were incubating those samples for
·2· · · ··the appropriate amount of time.
·3· ·Q· ··And why are incubators or are incubator logs
·4· · · ··required?
·5· ·A· ··So incubator logs are required and incubator
·6· · · ··temperature tracking is required because these
·7· · · ··microbials are living organisms.··Just like all of
·8· · · ··us here on this call today we all have an optimal
·9· · · ··temperature that we survive at.··And, for example,
10· · · ··if we have a temperature, a fever that starts to
11· · · ··creep into the 104-degree range, the actual
12· · · ··proteins in our brains start to denature.··Really
13· · · ··bad things can happen to a human body if it exists
14· · · ··outside of its optimal range.
15· · · · · · · · ··Similarly this can be translated to
16· · · ··microbials.··The difference is that microbials,
17· · · ··because they're such small organisms, often have a
18· · · ··much tighter range of acceptable temperature.
19· · · · · · · · ··And so these logs are important because
20· · · ··when the manufacturers validate these methods and
21· · · ··they create these methods for laboratories to use
22· · · ··they validate them at the optimal time and
23· · · ··temperature for the specific organism of target.
24· · · ··So if it was, you know, an aspergillus test, they
25· · · ··would validate that procedure for the optimal time

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·1· · · ··and temperature that it would take aspergillus to
·2· · · ··grow.··And the same thing for salmonella and
·3· · · ··E. coli.··They use those method validations to
·4· · · ··optimize those times and temperatures.
·5· · · · · · · · ··So the reason that it's important for a
·6· · · ··laboratory to keep track of temperature, to keep
·7· · · ··track of time, is to ensure that those tests that
·8· · · ··they're performing in the laboratory space occur
·9· · · ··within the appropriate temperature frame and the
10· · · ··appropriate time frame to ensure that the results
11· · · ··are accurate and reliable.
12· ·Q· ··And, for example, with aspergillus, what's that
13· · · ··appropriate time and temperature range?
14· ·A· ··So for aspergillus I believe -- I'd have to look.
15· · · ··I know that there is a very specific range.
16· · · · · · · · ··Aspergillus is not allowed to exceed 4
17· · · ··degrees Celsius on either side of its target and I
18· · · ··believe 4 degrees -- or four hours on either side
19· · · ··of its target either.
20· ·Q· ··Now, let's say -- what would happen if it was -- if
21· · · ··it was more than 4 degrees colder than the optimal
22· · · ··temperature range?
23· ·A· ··The organism would not grow properly.
24· ·Q· ··And what if it was 4 degrees higher?
25· ·A· ··The organism could very well die.··And then would

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·1· · · ··also subsequently not grow.
·2· ·Q· ··And what -- similarly, if you're talking you do it
·3· · · ··less than the optimal time range or more than the
·4· · · ··optimal time range?
·5· ·A· ··Correct.··So if you were to do it less than the
·6· · · ··optimal time range you may not get any growth at
·7· · · ··all or you may get less than what would be
·8· · · ··validated growth.··If you go for too long you're
·9· · · ··essentially going to bake the organism to death.
10· · · · · · · · ··And it's very important, especially in
11· · · ··microbial tests, and manufacturers even will put on
12· · · ··their product inserts that they validated those
13· · · ··tests at that specific temperature and at that
14· · · ··specific time range and that any deviations outside
15· · · ··of those would essentially render the method null
16· · · ··and void, and they would no longer provide warranty
17· · · ··on that method for inaccurate results.
18· ·Q· ··If you were to bake it too much and you kill it
19· · · ··isn't that a good thing?
20· ·A· ··No.··I mean, it would be good that the organism was
21· · · ··dead I suppose, but ultimately that's not going to
22· · · ··provide an accurate representation of the results
23· · · ··of that test to the individual who submitted the
24· · · ··test to you.··For example, the cultivator.··And it
25· · · ··also wouldn't provide accurate results to the end

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·1· · · ··consumer.
·2· ·Q· ··And if it is -- just because -- I'm sorry, I'm
·3· · · ··going to word -- try to word this the best way.
·4· · · ··Even if it's not grown to where it is visible, does
·5· · · ··that mean that aspergillus is still there?
·6· ·A· ··Just because it's not visible doesn't necessarily
·7· · · ··mean it's not there.
·8· ·Q· ··Okay.··So it doesn't have to get to a certain size
·9· · · ··to pose a risk to consumers?
10· ·A· ··Oh, no.··No.··If the spores are present, that can
11· · · ··pose a risk to consumers.
12· ·Q· ··Okay.··So when you went -- I'm going to sweep back
13· · · ··to that too.··You're using the words, you're saying
14· · · ··that logs and tracking are required.··Required by
15· · · ··what?
16· ·A· ··So appropriate environmental monitoring is
17· · · ··something that the ISO 17025 certification and
18· · · ··accreditation requires.··But it's also required by
19· · · ··the method manufacturers, as I mentioned.··For
20· · · ··example, a method vendor or method manufacturer
21· · · ··will say if you use this method outside of this
22· · · ··appropriate range we do not confirm that its
23· · · ··results are accurate and true.
24· · · · · · · · ··Going back to ISO, they do require that a
25· · · ··laboratory space keep appropriate tracking of time

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·1· · · ··and temperature to ensure that the methods are
·2· · · ··being run consistently according to the method
·3· · · ··parameters which are specified in their SOPs.
·4· ·Q· ··And what is ISO 17025?
·5· ·A· ··ISO 17025 is an accreditation program that we
·6· · · ··require all laboratories to be certified under.
·7· · · ··And it essentially is a program that oversees
·8· · · ··quality control in the laboratory space to ensure
·9· · · ··that a lab is maintaining the lab itself, its
10· · · ··staff, its procedures, its audits in a way that
11· · · ··ensures quality and thereby ensures accurate
12· · · ··consistent precise results.
13· ·Q· ··What would happen if a laboratory lost their
14· · · ··accreditation?
15· ·A· ··If a laboratory lost their accreditation, at least
16· · · ··for us here in the state of Michigan, we would not
17· · · ··allow them to be licensed or test under us.
18· · · · · · · · ··I suppose they could probably maintain
19· · · ··licensure technically, but we would not allow them
20· · · ··to report results out to consumers because we would
21· · · ··not be able to verify that those results are
22· · · ··accurate.
23· ·Q· ··Now, both ISO and the vendor, do they have a --
24· · · ··like a specific way to keep a log?
25· · · · · · · · ··And when I hear the word log I think of a

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·1· · · ··piece of paper where somebody writes everything
·2· · · ··down.
·3· ·A· ··So they do not.··They do not have a specific way
·4· · · ··that you can keep a log.··You can keep a log in any
·5· · · ··way as long as it contains a particular set of
·6· · · ··information.
·7· · · · · · · · ··So in particular when it relates to
·8· · · ··microbial tests and environmental monitoring we
·9· · · ··want to ensure that the log tells us the exact
10· · · ··temperature that the samples were incubated at over
11· · · ··the course of time that they were incubated for.
12· · · ··We want to verify that the temperature falls in the
13· · · ··appropriate manufacturer specified range, and we
14· · · ··want to ensure that the time that they're incubated
15· · · ··for falls within the appropriate manufacturer's
16· · · ··specified range.
17· · · · · · · · ··Additionally, we would need to keep track
18· · · ··of what samples were in that incubator for that
19· · · ··time for any particular day or number of days so
20· · · ··that if something went awry, for example if a
21· · · ··laboratory lost power in the middle of winter and
22· · · ··the samples got very, very cold overnight, that
23· · · ··would notify the laboratory, okay, our samples were
24· · · ··out of temperature, and it was these, you know, ten
25· · · ··samples here, for example.··We need to rerun those

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·1· · · ··samples because we cannot verify that the
·2· · · ··environmental controls were in place to ensure
·3· · · ··accurate results.
·4· · · · · · · · ··And that being said, I know that you said
·5· · · ··you think of a written log.··Doesn't have to be a
·6· · · ··written log.··It could be a written log.
·7· · · ··Oftentimes laboratories use electronic data through
·8· · · ··laboratory management systems.··I suppose if
·9· · · ··someone wanted they could keep 5,000 sticky notes
10· · · ··in a folder.··There just has to be something that
11· · · ··correlates the samples to the date to the
12· · · ··temperature to the time.··And they have to save
13· · · ··that for a period of time that's specified by their
14· · · ··ISO accrediting body.
15· ·Q· ··Why do they have to save those per their ISO
16· · · ··accrediting body?
17· ·A· ··Because that ensures -- well, it's part of their
18· · · ··records retention agreement that's prescribed for
19· · · ··the laboratory, but also it allows the laboratory
20· · · ··and auditors, regulators, etc., to go back over
21· · · ··time and ensure that the results that are being
22· · · ··reported are accurate and precise, and to ensure
23· · · ··that the laboratory is, honestly, performing the
24· · · ··appropriate quality management and quality control
25· · · ··oversight to say, okay, a lot of times in an ISO

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·1· · · ··audit an auditor will go back and say, okay, show
·2· · · ··me your monitoring logs from a year ago.··I want to
·3· · · ··see the last year of 2021 for example.··And so
·4· · · ··they'll review those logs and say you either were
·5· · · ··or were not in specification with the methods that
·6· · · ··you have written here.
·7· · · · · · · · ··And if a laboratory is not in
·8· · · ··specification with those methods, if it's out of
·9· · · ··range, the quality manager or laboratory oversight
10· · · ··should first of all catch that.··They would need to
11· · · ··write that up in some sort of a corrective action
12· · · ··procedure, some sort of a nonconformance report,
13· · · ··and they would need to retest those samples and
14· · · ··also let all of those clients know that those
15· · · ··samples were inaccurately reported.··Here are your
16· · · ··new results.··Essentially to correct their error
17· · · ··and notify them that an error was made.
18· ·Q· ··So you walk in there in October 2021.··Who goes
19· · · ··with you?
20· ·A· ··So in October of 2021 it was myself, Patrice
21· · · ··Fields, Noah Rosenzweig, and Allyson Chirio.··The
22· · · ··three of them are LSSs, or at least at that time
23· · · ··were LSSs.
24· ·Q· ··And what type of approach did you take?
25· ·A· ··So prior to actually going on site with this event

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·1· · · ··we had had I believe it was back and forth
·2· · · ··communications via email, potentially through Julie
·3· · · ··Kluytman as well, essentially notifying the
·4· · · ··laboratory that we wanted to come on site and
·5· · · ··perform an audit to help us better understand what
·6· · · ··was going on.
·7· · · · · · · · ··So we provided them a timeline of events.
·8· · · ··We let them know that we would be going to both the
·9· · · ··Lansing and the North locations.··We let them know,
10· · · ··I believe, what we wanted to look at in particular.
11· · · · · · · · ··And then when we actually got on site we
12· · · ··did the same thing.··You know, we went over the
13· · · ··proposed schedule of events, kind of opened it up,
14· · · ··discussed our concerns, and then asked if it would
15· · · ··be okay if we could go into the laboratory space
16· · · ··essentially to perform an audit of the methods in
17· · · ··question.
18· ·Q· ··And did that happen?
19· ·A· ··Yes, it did.
20· ·Q· ··Okay.··And how -- did you guys divide and conquer?
21· · · ··Did you kind of everybody stay together as a group?
22· · · ··How did you perform this audit?
23· ·A· ··For the audit portion we divided and conquered.
24· · · · · · · · ··It's not our practice to try and stay all
25· · · ··day at a laboratory.··We know they're busy.··They

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·1· · · ··have other operations going on.··So we thought it
·2· · · ··would be best to split up and try and get things
·3· · · ··done as quickly as possible while being thorough.
·4· · · · · · · · ··So -- I apologize.
·5· ·Q· ··No, go ahead.
·6· ·A· ··I was going to say so I believe Allyson Chirio
·7· · · ··oversaw foreign matter, myself and Noah Rosenzweig
·8· · · ··oversaw microbials, and I believe Patrice was kind
·9· · · ··of bouncing around between the few of us.··She was
10· · · ··a little bit newer at that point in time.
11· ·Q· ··Okay.··So we are going to talk about the part that
12· · · ··you took part in with Noah for the microbials.
13· · · ··And, obviously, that's what you've been talking
14· · · ··about a little bit with aspergillus falling under
15· · · ··that category.
17· ·Q· ··Okay.··So tell me what you did when you entered
18· · · ··into the lab.
19· ·A· ··So first when we entered into the lab space we went
20· · · ··right back to the area where they perform
21· · · ··microbials.··There were some, you know, technicians
22· · · ··or analysts back there that were I think actively
23· · · ··working on microbials.··The incubators were back
24· · · ··there.··And we essentially just asked them to walk
25· · · ··us through the process.··You know, when you get a

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·1· · · ··sample, what do you do with it.··How do you prepare
·2· · · ··it.··How do you put it in your machine.··And asked
·3· · · ··them some questions related to time and temperature
·4· · · ··logs.··Again, that was sort of what had sparked our
·5· · · ··concern.··And asked them to see their incubators,
·6· · · ··to see their incubator logs, to see their
·7· · · ··temperature logs.··And they showed us that
·8· · · ··information, or what was available of that
·9· · · ··information anyhow.
10· ·Q· ··And you did that at both locations?
12· ·Q· ··Okay.··And so we'll start with Viridis Lansing.
13· · · ··Who did you speak to there?
14· ·A· ··At Viridis Lansing --
15· ·Q· ··I'm sorry.··Go ahead.
16· ·A· ··At Viridis Lansing, specifically I know we talked
17· · · ··to Ross White.··I believe there were either one or
18· · · ··two other technicians or analysts that we spoke to
19· · · ··as well, but I cannot recall their names.
20· ·Q· ··Okay.··And when you asked them about the process,
21· · · ··time, temperature, what type of response did you
22· · · ··get?
23· ·A· ··So they explained the process.··And they did have
24· · · ··in form a temperature tracking log, but it was not
25· · · ··done through consistent temperature monitoring, it

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·1· · · ··was more of a thermometer placed in there instead
·2· · · ··of a long-term data log that would show any outages
·3· · · ··or deviation from temperature.
·4· · · · · · · · ··But they also let us know that they
·5· · · ··didn't track in and out time.··So the time the
·6· · · ··samples go in and the time the samples come out.
·7· · · ··Therefore they were not able to verify the total
·8· · · ··incubation time for those various microbial tests.
·9· ·Q· ··Did you express any concern to them about this
10· · · ··process?
11· ·A· ··Yes, I did.
12· ·Q· ··And what did you say?
13· ·A· ··I specifically let them know that we had concerns
14· · · ··about the fact that they weren't tracking time
15· · · ··because there's no way for them to verify to
16· · · ··themselves internally or us or their clients that
17· · · ··they were tracking time on these methods that are,
18· · · ··honestly, that have very strict time controls.
19· · · ··Like I said, within four hours, plus or two -- plus
20· · · ··or minus two hours either way of the target.
21· ·Q· ··And their SOP that was on file and approved, did it
22· · · ··track these things like they're required to do or
23· · · ··indicate that they were to be tracking those?
24· ·A· ··So in their SOP it did not explicitly state that
25· · · ··they were supposed to track those things; however,

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·1· · · ··that information is inherent.
·2· · · · · · · · ··Whenever there is a method that calls for
·3· · · ··time and temperature tracking you can't just guess
·4· · · ··at that.··It's something -- there has to be some
·5· · · ··way of monitoring information over time.··The
·6· · · ··easiest, simplest, and most commonly accepted way
·7· · · ··to do that is to create some sort of a log over
·8· · · ··time.
·9· ·Q· ··Did their SOP contain temperatures, the range that
10· · · ··they knew that this should be held at?
11· ·A· ··Yes, they did.
12· ·Q· ··And did the SOP contains the times as in it should
13· · · ··be in there for this many hours?
14· ·A· ··Yes, it did.
15· ·Q· ··It just didn't specify how it was going to be kept
16· · · ··track of?
18· ·Q· ··Is that normal with most of the SOPs or all of the
19· · · ··SOPs dealing with microbials?
20· ·A· ··Yes.··It's very common that a laboratory doesn't
21· · · ··tell us specifically we are going to track this on
22· · · ··a handwritten paper log, it's something that,
23· · · ··again, is inherent in laboratory operations.··You
24· · · ··have to ensure that you are meeting the parameters
25· · · ··of your SOP.··How you choose to do that is up to

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·1· · · ··you.
·2· · · · · · · · ··I personally would recommend a data log,
·3· · · ··but, you know, if something else sparks you, by all
·4· · · ··means, please.
·5· ·Q· ··And as long as it was presented to you, is it
·6· · · ··something that the CRA would accept if they could
·7· · · ··decipher time in, time out, temperature in, how
·8· · · ··long it was there?
·9· ·A· ··We would want to see date, samples affected, time
10· · · ··in, time out, and temperature in any form or
11· · · ··format.··It wouldn't matter how it was presented as
12· · · ··long as that record was kept.
13· ·Q· ··Okay.··Did you feel as though Viridis Laboratories
14· · · ··was acting in accordance with their SOP when you
15· · · ··were there for the audit pertaining to microbials?
16· ·A· ··No, I do not.
17· ·Q· ··And did you go then to Viridis North?
18· ·A· ··Yes, we did.
19· ·Q· ··Or within a day or some point in time you went?
20· ·A· ··I believe it was the following day, yes.
21· ·Q· ··Okay.··Was that situation similar to Viridis
22· · · ··Lansing?
23· ·A· ··Yes, it was.
24· ·Q· ··Divide and conquer at that point as well?
25· ·A· ··Yep.··Absolutely.··Come in, set the stage, discuss

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·1· · · ··what was happening in order to make things as
·2· · · ··timely as possible.··Divide and conquer.
·3· ·Q· ··Okay.··And did you and Noah deal with the issues of
·4· · · ··microbials?
·5· ·A· ··So there was -- that laboratory I believe is a bit
·6· · · ··bigger, and so Noah and I did deal with microbials
·7· · · ··in part.··I also during that time bounced over to
·8· · · ··foreign matter.··I believe I also was speaking with
·9· · · ··Michele Glinn and Mr. Blair, Kevin Blair, at that
10· · · ··time as well.
11· · · · · · · · ··So we were just all kind of moving about
12· · · ··asking various questions just to make sure that we
13· · · ··were completing the audit in the most complete way
14· · · ··possible.
15· ·Q· ··Okay.··I'm going to start out with the work that
16· · · ··you had done with microbials while you were at
17· · · ··Viridis North.··Tell me what you did there.
18· ·A· ··So we asked the same kinds of questions.··Are you
19· · · ··keeping some sort of a temperature tracking device
20· · · ··that would track temperature over time.··Are you
21· · · ··keeping a log in terms of, you know, whatever kind
22· · · ··of log you want to keep, I suppose, but to track in
23· · · ··and out times.··Same thing to ensure that the
24· · · ··method is being run according to the SOP.
25· · · · · · · · ··We additionally at that location looked a

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·1· · · ··little bit more into how they were keeping their
·2· · · ··solvents and their reagents, in particular for
·3· · · ··these microbial tests, whether the fridge or the
·4· · · ··incubator was at the appropriate temperature just
·5· · · ··making sure that everything was in specification
·6· · · ··according to the manufacturer's method.
·7· ·Q· ··And was it?
·8· ·A· ··No, it was not.
·9· ·Q· ··What did you observe?
10· ·A· ··So at that location again we also observed that for
11· · · ··a period of time the temperature was not being
12· · · ··tracked and that also the time in and time out,
13· · · ··total incubation time, was not being tracked in
14· · · ··some format.
15· ·Q· ··Did you express your concerns while you were there?
16· ·A· ··Yes, we did.
17· ·Q· ··Okay.··Do you feel as though they were acting in
18· · · ··accordance with the SOP that they had on file
19· · · ··pertaining to microbials?
20· ·A· ··No, I do not.
21· ·Q· ··And you said that you were also a little bit
22· · · ··involved in foreign matter.··What did you do with
23· · · ··that?
24· ·A· ··That is correct.··So at the Viridis North location
25· · · ··I was pulled in to observe foreign matter by

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·1· · · ··Dr. Chirio.··And I was just observing the
·2· · · ··technician staff performing what should have been
·3· · · ··their method in order to analyze plant samples
·4· · · ··according to their procedure for the presence of
·5· · · ··any foreign -- well, foreign matter.··And that
·6· · · ··could be mold.··That could be spores.··That could
·7· · · ··be pests, like mites and bugs.··That could be pest
·8· · · ··excrement material.··But it could also be things
·9· · · ··like glass or metal shavings or plastic or any sort
10· · · ··of object or thing, be it biologic or nonbiologic,
11· · · ··that's in those samples that isn't plant material
12· · · ··or shouldn't be there.
13· ·Q· ··Are these types of things visible with the naked
14· · · ··eye?
15· ·A· ··Not typically, no.
16· ·Q· ··Then how are they detected?
17· ·A· ··So these things are detected using some sort of a
18· · · ··dissecting microscope typically at pretty intense
19· · · ··magnifications in order to really get down to the
20· · · ··sample at a magnified level and see if you can
21· · · ··identify mold or if you can identify hyphae, which
22· · · ··is how mold grows, mold spores or any of those tiny
23· · · ··little microorganisms.
24· ·Q· ··And as they're magnified -- when you have a foreign
25· · · ··matter SOP does it cover all of the parameter of

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·1· · · ··how much it should be magnified or how long it
·2· · · ··should be looked at?··Is that the type of things
·3· · · ··that are taken into account?
·4· ·A· ··Yes, they are.
·5· · · · · · · · ··So when you are looking at a sample
·6· · · ··visually under some sort of a dissecting scope you
·7· · · ··have a specific range of magnification that you're
·8· · · ··looking at the sample under.··You're typically
·9· · · ··looking at the sample for five minutes or so.··I
10· · · ··believe Viridis in particular says about five
11· · · ··minutes.··And you're moving the magnification up
12· · · ··and down because this isn't a flat piece of paper
13· · · ··that we're looking at.··It's a very complex floral
14· · · ··structure.··There are peaks and valleys.
15· · · · · · · · ··So you're dissecting the sample.··You're
16· · · ··looking at different parts of it, you know, the
17· · · ··tops of the flower part, the bottoms of the flower
18· · · ··part, the stem, to really assess what's on there so
19· · · ··that you can report that out, not just under the
20· · · ··regulatory requirements but report that out to the
21· · · ··cultivator or the client and let them know if they
22· · · ··have any pest or pathogen problems.
23· ·Q· ··Have you ever seen a situation where you can see
24· · · ··mold or something with the visible eye?
25· ·A· ··Oh, yes, there are occasions where you can see mold

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·1· · · ··with the visible eye.··In particular there's one
·2· · · ··particular mold that's called bud rot, and it will
·3· · · ··completely take over a cannabis flower.··And you
·4· · · ··can see it on the outside.··If you touch it or poke
·5· · · ··it it looks like it smokes almost.··All the spores
·6· · · ··will kind of pop up, and you can visually see them
·7· · · ··if you have reasonably decent vision.
·8· ·Q· ··So when you were at Viridis North what did you
·9· · · ··observe pertaining to the foreign matter that -- or
10· · · ··was there anything that caused concern?
11· ·A· ··So -- well, aside from the deviations from the SOP,
12· · · ··and I can get into those further if you would
13· · · ··like --
14· ·Q· ··Yes, please.
15· ·A· ··Okay.··So at that point in time I noticed that the
16· · · ··technician was not following the magnification that
17· · · ··they were supposed to use in the SOP.··They're
18· · · ··additionally supposed to use I think it's 100
19· · · ··square grid essentially that would allow them to
20· · · ··calculate the percent of total contamination.··And
21· · · ··they use that in order to calculate whether the
22· · · ··foreign matter test is a pass or a fail based on
23· · · ··our regulations.··So they were not using that at
24· · · ··all.
25· · · · · · · · ··They were taking a very short period of

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·1· · · ··time, I would say 30 seconds to one minute while we
·2· · · ··were on site, whereas their SOP stated that they
·3· · · ··should be looking at it for five minutes.··And they
·4· · · ··were not performing the appropriate level of
·5· · · ··dissection to even begin to look at these samples
·6· · · ··in a thorough enough way that would provide a
·7· · · ··comprehensive analysis.
·8· · · · · · · · ··MR. RUSSELL:··Judge, not to interrupt,
·9· · · ··but when Ms. Huyser's done with this line of
10· · · ··questioning can we take a quick break?··I need to
11· · · ··make a phone call if possible.
12· · · · · · · · ··MS. HUYSER:··If we need to take a break
13· · · ··now it's whatever the Court needs because I'm going
14· · · ··to be a few more minutes with her.
15· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Well, we'll
16· · · ··just break now then.
17· · · · · · · · ··It's 3:02.··How long do you need,
18· · · ··Counsel?
19· · · · · · · · ··MR. RUSSELL:··Can you give me 15 minutes?
20· · · ··Is that okay?
21· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah, we'll just break
22· · · ··till 3:15.··Is that okay?
23· · · · · · · · ··MR. RUSSELL:··Thank you.
24· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Off the
25· · · ··record at 3:02.··Thank you.

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·2· · · · · · · · ··(Break taken at 3:02 PM)
·3· · · · · · · · ··(Break concluded at 3:16 PM)
·4· · · · · · · · ··JUDGE GOLDSTEIN:··We're back on the
·5· · · ··record in the matter of Viridis Laboratories, LLC,
·6· · · ··and Viridis North, LLC, versus Cannabis Regulatory
·7· · · ··Agency, consolidated Dockets 21-029794, et al.··The
·8· · · ··time is 3:16 PM.
·9· · · · · · · · ··Ms. Huyser, you may continue.
11· · · · · · · · ··JUDGE GOLDSTEIN:··You're welcome.
12· ·Q· ··(MS. HUYSER) So, Ms. Patterson, we were talking
13· · · ··about Viridis North and what you observed as far as
14· · · ··foreign matter while you were there.··You were
15· · · ··explaining how they were not -- your opinion that
16· · · ··they were not being compliant with the SOP that
17· · · ··they had on file for foreign matter.··And so you
18· · · ··mentioned the grid, the magnification, the time,
19· · · ··and we were talking about dissection.
20· · · · · · · · ··So when you use the word dissection what
21· · · ··do you mean?
22· ·A· ··So when I use the term dissection, particularly as
23· · · ··it relates to cannabis flower -- let me explain the
24· · · ··physiology of the plant if I may just a moment.
25· ·Q· ··Yes, please.

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·1· ·A· ··So the cannabis flower, it has a primary stem but
·2· · · ··it also has little tiny florets, much like you
·3· · · ··would see in broccoli.··So it's one flower but
·4· · · ··there's also little teeny pieces and florets there.
·5· · · · · · · · ··And so when you're looking at a cannabis
·6· · · ··flower you want to dissect those little florets off
·7· · · ··like you would do to get your broccoli florets.
·8· · · ··And the purpose of that is to actually get into
·9· · · ··those really close spaces.··So, as with a head of
10· · · ··broccoli, you know, it's very tightly and compact
11· · · ··sort of together.··So you want to open those up to
12· · · ··see if there's any mold or pests in there because
13· · · ··that's where that kind of stuff grows and lives and
14· · · ··hides.··So it's important to do that dissection in
15· · · ··order to open the bud up and actually see, you
16· · · ··know, are there any little critters hiding in
17· · · ··there.
18· ·Q· ··And what you observed, they weren't properly doing
19· · · ··that?
21· ·Q· ··What were they doing?
22· ·A· ··They were taking full or largely full buds and just
23· · · ··inspecting the outside portions of them, which can
24· · · ··provide some information but is not what it says to
25· · · ··do in their procedure and, as I stated, doesn't

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·1· · · ··provide a full picture of what may or may not be
·2· · · ··hiding on the inside portions of those flowers.
·3· ·Q· ··Did you observe anything else that you would have
·4· · · ··considered a deviation from their approved
·5· · · ··procedure?
·6· ·A· ··We discussed the not using the appropriate
·7· · · ··magnification, not using the grid in order to
·8· · · ··appropriately pass or fail samples, not dissecting
·9· · · ··the samples, and then also not viewing the samples
10· · · ··for the appropriate amount of time.··Beyond that I
11· · · ··don't believe there was anything else.
12· ·Q· ··Okay.··And while you were there did you discuss
13· · · ··these deviations with anyone?
14· ·A· ··Yes, I did, actually.
15· · · · · · · · ··So we went back up to the conference
16· · · ··space.··We discussed some of these issues, well,
17· · · ··all of these issues rather, with the management
18· · · ··staff.··So that would have been the executive
19· · · ··management team as well as the laboratory
20· · · ··management staff that was there, the upper level,
21· · · ··you know, day-to-day management.··And in particular
22· · · ··we discussed the fact that I had seen some powdery
23· · · ··mildew on some of the flowers and that it was not
24· · · ··noted.
25· · · · · · · · ··And so at that point in time Michael

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·1· · · ··LaFramboise, as I had previously noted, actually
·2· · · ··was, like, very engaged.··Asked me to come back
·3· · · ··down to the laboratory with him and a technician
·4· · · ··and show him exactly what it was that they should
·5· · · ··be doing and to show him where we found that
·6· · · ··powdery mildew, what I was talking about.··I kind
·7· · · ··of showed him an example of it.··And he was very
·8· · · ··engaged in that process.
·9· ·Q· ··And was there a reason as to why it wasn't written
10· · · ··down?
11· ·A· ··I cannot speak to that.··I do not know.
12· ·Q· ··So one wasn't offered to you?
14· ·Q· ··So what did you do next after going back and
15· · · ··looking at the powdery mildew?··Did you have -- you
16· · · ··mentioned you had some conversations with Michele
17· · · ··Glinn, that she was present there.
18· ·A· ··That is correct.··Yes, we did.··And, like I said,
19· · · ··the whole management staff was there.··And to wrap
20· · · ··up our audits we talked to them about the audit
21· · · ··findings that we had found on site, explained it
22· · · ··all in detail.··As per usual we, you know, went
23· · · ··over everything but allowed them the opportunity
24· · · ··for questions, concerns, things of that nature
25· · · ··essentially so we could have that conversation in

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·1· · · ··person before we issued an audit response to them
·2· · · ··in writing.
·3· ·Q· ··Okay.··And were any questions or concerns presented
·4· · · ··to you?
·5· ·A· ··I believe there were some questions, particularly
·6· · · ··as it related to, you know, the foreign matter,
·7· · · ··what was or was not detected.
·8· · · · · · · · ··And I don't like to say this again, but
·9· · · ··it felt a little bit adversarial in nature at that
10· · · ··point in time.··It seemed like the audit findings
11· · · ··that we brought forth, there was a lot of
12· · · ··contention about whether or not they were actually
13· · · ··appropriate audit findings or if they were
14· · · ··deviations from the method.··And we verified that
15· · · ··according to our methods that we had on file they
16· · · ··were deviations and that they would be going into
17· · · ··those audit findings.
18· ·Q· ··And once you find an audit that there's deviations
19· · · ··or that there are concerns, what happens next?
20· ·A· ··So if we find in an audit that there are deviations
21· · · ··from an SOP or multiple SOPs we will investigate
22· · · ··that.··So we'll take that through the investigatory
23· · · ··process because our laboratories are required to
24· · · ··use SOPs that have been approved and -- by the
25· · · ··Agency, and they're supposed to use them as they've

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·1· · · ··been written and approved.··So when we notice a
·2· · · ··deviation of that, that's an investigation.··We're
·3· · · ··going to follow that up through the investigatory
·4· · · ··route.
·5· ·Q· ··So at this point you had the investigation that had
·6· · · ··been started back in March; correct?
·8· ·Q· ··And is this kind of just an evolving process when
·9· · · ··there's investigations and more things come in or
10· · · ··is it separate investigations that get started
11· · · ··every issue?
12· ·A· ··They're separate investigations that get started
13· · · ··with every issue.
14· · · · · · · · ··I will admit this is the first time we've
15· · · ··had this many investigations related to a
16· · · ··laboratory not following their procedures.··So, you
17· · · ··know, they started to blend together I think for
18· · · ··everybody because these issues continued to
19· · · ··compound; however, they are separate issues and
20· · · ··were addressed separately in separate investigation
21· · · ··reports.
22· · · · · · · · ··MR. RUSSELL:··I just want to place an
23· · · ··objection on the record for lack of foundation.··I
24· · · ··think Ms. Huyser referenced a March investigation.
25· · · ··I'm not sure exactly what she's referring to.

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·1· · · · · · · · ··MS. HUYSER:··There was testimony
·2· · · ··previously provided that after December that they
·3· · · ··had started an investigation in March.··We asked a
·4· · · ··question why wasn't it done sooner.··She went and
·5· · · ··explained.··I was referring back to previous
·7· · · · · · · · ··MR. RUSSELL:··All right.··Just so the
·8· · · ··record's clear then was the question that this was
·9· · · ··an ongoing as part of that March investigation when
10· · · ··they were on site in October?
11· · · · · · · · ··MS. HUYSER:··No, my question was if
12· · · ··continuous defects or continuous problems arise
13· · · ··does it become just a part of the investigation
14· · · ··that's ongoing or is there a new investigation
15· · · ··every single time.
16· · · · · · · · ··MR. RUSSELL:··Thanks for clarifying.
17· · · · · · · · ··MS. HUYSER:··No problem.
18· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you.··Go ahead,
19· · · ··Counsel.
20· ·Q· ··(MS. HUYSER) Throughout your involvement with
21· · · ··Viridis, Ms. Patterson, do you believe -- well,
22· · · ··actually, sorry.··I'm going to restate that.··My
23· · · ··fault.
24· · · · · · · · ··Is there a rule that requires that
25· · · ··laboratory managers be in place?

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·1· ·A· ··Yes, there is.
·2· ·Q· ··Tell me a little bit about that rule.
·3· ·A· ··So our rule specifically as it relates to
·4· · · ··laboratory managers is that they're -- they have a
·5· · · ··specific set of qualifications through their
·6· · · ··education and experience and that they are there
·7· · · ··and available to oversee the day-to-day activities
·8· · · ··of the laboratory.··That includes, you know,
·9· · · ··day-to-day routine testing that test -- well,
10· · · ··ensuring that tests are performed according to the
11· · · ··SOPs.··Ensuring that the data is accurate and
12· · · ··precise.··Overseeing quality in some form or
13· · · ··fashion and making sure that the laboratory
14· · · ··operates as a nonbiased accurately reporting
16· ·Q· ··And if we're talking about that rule, let's start
17· · · ··with Viridis Lansing, do you believe that they have
18· · · ··a laboratory manager on staff that was doing this?
19· ·A· ··I do not.
20· ·Q· ··Why not?
21· ·A· ··Because the deviations that we saw both with the
22· · · ··potency investigations as well as the microbial and
23· · · ··foreign matter investigations demonstrated that
24· · · ··there was no rigorous day-to-day oversight of
25· · · ··operations.

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·1· · · · · · · · ··I have been a laboratory manager myself,
·2· · · ··and when we identify deviations from an SOP, that's
·3· · · ··something that should immediately be cause for
·4· · · ··concern in the laboratory space.
·5· · · · · · · · ··When you notice a deviation, as a
·6· · · ··laboratory manager it is your responsibility to
·7· · · ··stop the staff that are performing those
·8· · · ··investigations -- or performing those routine
·9· · · ··analyses, have them retrained.··Have them rerun
10· · · ··results.··Anything that fell out of specification
11· · · ··with those SOPs.··And we didn't notice that at
12· · · ··Viridis Lansing particularly as it relates to these
13· · · ··tests in question.
14· ·Q· ··And with Viridis North same question.
15· ·A· ··And the same response.··I would lean towards more
16· · · ··the fact that there was slightly more oversight at
17· · · ··the Viridis North location.··But even still we
18· · · ··noted that there were things that were not being
19· · · ··done in specification with the SOP.··The SOPs were
20· · · ··not being followed for potency, microbial, or
21· · · ··foreign matter.··And that's something that a
22· · · ··laboratory manager has to oversee.
23· ·Q· ··And if we were to move on to there is a rule
24· · · ··requirement that requires that all labs have their
25· · · ··SOPs, and they're required to actually follow

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·1· · · ··those; correct?
·3· ·Q· ··Do you believe that that was done in either of the
·4· · · ··Viridis North or Viridis Lansing labs?
·5· ·A· ··As it relates to potency, all of the microbial
·6· · · ··methods, foreign matter and also some of the
·7· · · ··quality management procedures, no, I do not believe
·8· · · ··they were following their methods.
·9· ·Q· ··And what are quality management procedures?
10· ·A· ··So quality management procedures are the procedures
11· · · ··that oversee, frankly, quality in the laboratory
12· · · ··space.··It -- essentially, it puts a person or a
13· · · ··group of people in place that reviews results.
14· · · ··They look at the data.··They make sure that those
15· · · ··methods were performed according to the method.
16· · · ··That the data comes out and it falls within a
17· · · ··specific set of parameters.··And if there is any
18· · · ··data that is out of those parameters it's their
19· · · ··duty to flag those and say, as I said previously,
20· · · ··you know, the staff needs retraining.··These
21· · · ··samples need to be rerun.··It's their duty to
22· · · ··ensure that the data that's going out to clients is
23· · · ··accurate and it's been accurately reported.··And if
24· · · ··it's not, they need to record that information,
25· · · ··they need to fix it, and then they need to report

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·1· · · ··the new information to the client.
·2· ·Q· ··And why do you believe that Viridis North or
·3· · · ··Viridis Lansing were not doing that?
·4· ·A· ··I believe that they were not doing that because
·5· · · ··they didn't have a number of things in place to
·6· · · ··ensure that they were following their SOPs.··For
·7· · · ··instance, in the way of potency we know that they
·8· · · ··weren't following the SOPs that they had approved
·9· · · ··on file.··They made numerous changes to those SOPs
10· · · ··and were not requiring staff to follow the SOPs
11· · · ··that were approved.
12· · · · · · · · ··When it comes to the microbial methods
13· · · ··they had a number of data points that were out of
14· · · ··specification with the appropriate temperature
15· · · ··ranges.··They were not logging times.··They had no
16· · · ··way to verify that the samples were incubated for
17· · · ··the appropriate amounts of time.··And we have data
18· · · ··on that, or a lack of data on that, spanning back
19· · · ··months prior to the audit.
20· · · · · · · · ··And as part of their quality procedures
21· · · ··it required management and oversight to catch these
22· · · ··things first of all, to note them, and then to
23· · · ··correct them and issue new reports.··And that never
24· · · ··happened.··We asked if there were any corrective
25· · · ··actions on file or nonconformances that had noted

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·1· · · ··these deviations and there were absolutely none.
·2· ·Q· ··And do you believe that when looking at their
·3· · · ··analytical testing methods and the required safety
·4· · · ··tests that there was any validation that was done
·5· · · ··by any independent third party that would satisfy
·6· · · ··the requirements set -- did we lose them?
·7· · · · · · · · ··JUDGE GOLDSTEIN:··I think that we did
·8· · · ··lose them.
·9· · · · · · · · ··MS. HUYSER:··Sorry.··I looked up and I
10· · · ··noticed we were missing a screen.
11· · · · · · · · ··THE WITNESS:··I wasn't going to answer
12· · · ··until we got them back.
13· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah, we'll just take a
14· · · ··break here.
15· · · · · · · · ··(Break taken at 3:30 PM)
17· · · · · · · · ··JUDGE GOLDSTEIN:··So we're back on the
19· · · ··and Viridis North, LLC, consolidated Docket Numbers
20· · · ··21-029794, et al.
21· · · · · · · · ··The record should reflect that around --
22· · · ··right around 3:30 I think we lost Viridis counsel,
23· · · ··whoever was in the room there, and they just got
24· · · ··back on.
25· · · · · · · · ··So we were going to conclude at 4:00

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·1· · · ··today.··We will go ahead and conclude for the day.
·2· · · ··Start back tomorrow morning at 9:00 in the morning,
·3· · · ··and we have till 5:00 tomorrow.··The remaining
·4· · · ··we'll go to 5:00 as well, unless something comes
·5· · · ··up.
·6· · · · · · · · ··MR. RUSSELL:··Judge, real quick.
·7· · · ··Tomorrow, I realize -- I have a daughter that has a
·8· · · ··lacrosse game at 5:00.··Is there any way we can end
·9· · · ··a little bit early?··Does anyone have an objection
10· · · ··to that?
11· · · · · · · · ··JUDGE GOLDSTEIN:··No.
12· · · · · · · · ··MS. HUYSER:··We don't.
13· · · · · · · · ··JUDGE GOLDSTEIN:··That's fine with the
14· · · ··Tribunal, as long as you all know if you need to
15· · · ··end before 5:00, that's fine too, just make sure --
16· · · ··but we have it set aside until five, so I will --
18· · · · · · · · ··JUDGE GOLDSTEIN:··I'd like to say
19· · · ··sometimes things come up at the last minute and I
20· · · ··don't have a choice but to adjourn to take care of
21· · · ··whatever else comes along during the day so -- I'll
22· · · ··try not to let that happen though.
23· · · · · · · · ··So at this point we'll conclude for the
24· · · ··day and we'll reconvene at 9:00 tomorrow morning.
25· · · ··Okay?

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·1· · · · · · · · ··MR. RUSSELL:··Thank you.
·2· · · · · · · · ··MS. HUNT-SCULLY:··Thank you, Your Honor.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··We're off the record at
·5· · · ··3:53 PM.··Have a good evening.
·6· · · · · · · · ··MS. HUYSER:··You too as well.
·7· · · · · · · · ··MR. RUSSELL:··You too.··Thank you.
·8· · · · · · · · ··(Record closed at 3:53 PM)
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·1· · · · · · · · ·CERTIFICATE OF NOTARY PUBLIC

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·3· · · ··I certify that this transcript, consisting of 218
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·4· ·pages, is a complete, true, and correct transcript of the
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·5· ·proceedings and testimony taken in this case on May 15,
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·6· ·2023.
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16· · · · · · · · ··Suzanne Duda, CSR-3199, RPR, CRR
· · · · · · · · · ··Notary Public, Clinton County, Michigan
17· · · · · · · · ··My commission expires:··May 6, 2025
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(517) 388-3128
Viridis v CRA, Vol. 2
·1· · · · · · · · · · ·· STATE OF MICHIGAN

· ··
·2· · ··MICHIGAN OFFICE OF ADMINISTRATIVE HEARINGS AND RULES
· ··
·3· · VIRIDIS LABORATORIES, LLC,
· · · a Michigan limited liability· · · ·Docket No.: 21-029794
·4· · company, and VIRIDIS NORTH, LLC,
· · · a Michigan limited liability· · · ·Case Nos.: SC-000009,
·5· · company,· · · · · · · · · · · · · · · · · · ··SC-000014
· ··
·6· · · ·· Petitioners,· · · · · · · · ··Agency: Cannabis
· · · · · · · · · · · · · · · · · · · ·· Regulatory Agency
·7· · v
· · · · · · · · · · · · · · · · · · · · ·Case Type: MMF Public
·8· · MICHIGAN CANNABIS REGULATORY· · · ·Investigative Hearings
· · · AGENCY, a Michigan state agency,
·9· · · · · · · · · · · · · · · · · · ·· Filing Type: Complaint
· · · · ·· Respondent,· · · · · · · · · ·by Licensee
10· ·
· · · and· · · · · · · · · · · · · · · ··CONSOLIDATED with:
11· ·
· · · MICHIGAN CANNABIS REGULATORY· · · ·Docket Nos.:
12· · AGENCY, a Michigan state agency,· ·22-017866, 22-018127,
· · · · · · · · · · · · · · · · · · · ·· 22-018128, 22-018129
13· · · ·· Petitioner,
· · · · · · · · · · · · · · · · · · · · ·Case Nos.:
14· · v· · · · · · · · · · · · · · · · ··21-000189, 21-001041,
· · · · · · · · · · · · · · · · · · · · ·21-001065, 21-000191,
15· · VIRIDIS LABORATORIES, LLC,· · · · ·21-001044, 22-001066,
· · · a Michigan limited liability· · · ·21-000192, 21-001043,
16· · company, and VIRIDIS NORTH, LLC,· ·21-000193, 21-001045
· · · a Michigan limited liability
17· · company,· · · · · · · · · · · · · ·Agency: Cannabis
· · · · · · · · · · · · · · · · · · · ·· Regulatory Agency
18· · · ·· Respondents.
· · · · · · · · · · · · · · · · · · · ·· Case Type: MMF
19· · · · · · · · · · · · · · · · · · · ·Disciplinary Hearings
· ··
20· · · · · · · · · · · · · · · · · · ·· Filing Type: Formal
· · · _____________________________/· · ·Complaint
21· ·
· ··
22· · · · · · · · · · · · ·· VOLUME 2
· ··
23· ·· REMOTE PROCEEDINGS HELD IN THE ABOVE-ENTITLED MATTER
· ··
24· · ··BEFORE ADMINISTRATIVE LAW JUDGE STEPHEN B. GOLDSTEIN
· ··
25· · · · · · · ·· TUESDAY, MAY 16, 2023, 9:02 AM
Page 220
·1· ·REMOTE APPEARANCES:

· ··
·2· · · ··MR. DAVID R. RUSSELL (P68568)
· · · · ··MR. BRANDON M. H. SCHUMACHER (P82930)
·3· · · ··FOSTER, SWIFT, COLLINS & SMITH, PC
· · · · ··313 South Washington Square
·4· · · ··Lansing, Michigan 48933
· · · · ··(517)371-8150
·5· · · ··drussell@fosterswift.com
· · · · ··bschumacher@fosterswift.com
·6· ·
· · · · · · · ·Appearing on Behalf of Viridis
·7· ·
· · · · ··MS. RISA HUNT-SCULLY (P58239)
·8· · · ··MS. SARAH E. HUYSER (P70500)
· · · · ··MR. ADAM M. LAYTON (P80646)
·9· · · ··MICHIGAN DEPARTMENT OF ATTORNEY GENERAL
· · · · ··525 West Ottawa Street
10· · · ··Lansing, Michigan 48933
· · · · ··(517)373-1146
11· · · ··huntscullyr@michigan.gov
· · · · ··huysers2@michigan.gov
12· · · ··leytona1@michigan.gov
· ··
13· · · · · · ·Appearing on Behalf of Michigan CRA
· ··
14· ·
· ··
15· ·ALSO PRESENT:
· ··
16· · · ··Michele Glinn
· · · · ··Erika Marzorati
17· · · ··Greg Michaud
· · · · ··Lorri Rosier
18· ·
· ··
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· ··
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· ··
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· ··
22· ·
· ··
23· ·
· ··
24· ·
· ··
25· ·REPORTED BY: Suzanne Duda, CSR-3199, RPR, CRR

(517) 388-3128
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·1· · · · · · · · · · ··INDEX OF WITNESSES
·2· ·WITNESS:
·3· ·CLAIRE PATTERSON· · · · · · · · · · · · · · · · · ·PAGE
·4· · · ··Direct Examination, Cont., by Ms. Huyser· · · ·225
·5· · · ··Cross-Examination by Mr. Russell· · · · · · · ·234
·6· · · · · · · · · · ··INDEX OF EXHIBITS
·7· ·CRA EXHIBITS ADMITTED:· · · · · · · · · · · · · · ·PAGE
·8· · · ··CRA Exhibit 50· · · · · · · · · · · · · · · · ·232
·9· ·VIRIDIS EXHIBITS ADMITTED
10· · · ··Viridis Exhibit 1· · · · · · · · · · · · · · ··274
11· · · ··Viridis Exhibit 2· · · · · · · · · · · · · · ··281
12· · · ··Viridis Exhibit 3· · · · · · · · · · · · · · ··320
13· · · ··Viridis Exhibit 4· · · · · · · · · · · · · · ··310
14· · · ··Viridis Exhibit 5· · · · · · · · · · · · · · ··336
15· · · ··Viridis Exhibit 6· · · · · · · · · · · · · · ··353
16· · · ··Viridis Exhibit 7· · · · · · · · · · · · · · ··367
17· · · ··Viridis Exhibit 8· · · · · · · · · · · · · · ··372
18· · · ··Viridis Exhibit 9· · · · · · · · · · · · · · ··379
19· · · ··Viridis Exhibit 10· · · · · · · · · · · · · · ·384
20· · · ··Viridis Exhibit 11· · · · · · · · · · · · · · ·389
21· · · ··Viridis Exhibit 12· · · · · · · · · · · · · · ·391
22· · · ··Viridis Exhibit 13· · · · · · · · · · · · · · ·411
23· ·
24· ·
25· ·

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·1· · · · · · · · · · · · · · · · ·Tuesday, May 16, 2023
·2· · · · · · · · · · · · · · · · ·9:02 AM
·3· · · · · · · · · · ··R E C O R D
·4· · · · · · · · ··JUDGE GOLDSTEIN:··We are on the record in
·6· · · ··Viridis North versus Cannabis Regulatory Agency,
·7· · · ··consolidated Docket Numbers 21-029794, 22-017866,
·8· · · ··22-018127, 22-018128, and 22-018129.
·9· · · · · · · · ··Today is May 16, 2023, the date for a
10· · · ··continuing hearing in this matter.
11· · · · · · · · ··Let me get some appearances again
12· · · ··starting with the Agency.
13· · · · · · · · ··MS. HUNT-SCULLY:··Yes.··Good morning,
14· · · ··Your Honor.··Risa Hunt-Scully appearing on behalf
15· · · ··of the Cannabis Regulatory Agency.
16· · · · · · · · ··MS. HUYSER:··Sarah Huyser on behalf of
17· · · ··the Cannabis Regulatory Agency.
18· · · · · · · · ··JUDGE GOLDSTEIN:··And on behalf of
19· · · ··Viridis?
20· · · · · · · · ··MR. RUSSELL:··Good morning, Your Honor.
21· · · ··David Russell on behalf of Viridis North, LLC, on
22· · · ··behalf of Viridis Laboratories, LLC.
23· · · · · · · · ··MR. SCHUMACHER:··Good morning, Your
24· · · ··Honor.··Brandon Schumacher appearing on behalf of
25· · · ··Viridis Laboratories, LLC, and Viridis North, LLC.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Well, now I realize
·2· · · ··I've been mispronouncing your client's name this
·3· · · ··whole time.··My apologies.
·4· · · · · · · · ··MR. RUSSELL:··Viridis.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Viridis.··Okay.
·6· · · · · · · · ··MR. RUSSELL:··Yes.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you.
·8· · · · · · · · ··My apologies for that.
·9· · · · · · · · ··MR. RUSSELL:··No problem.
10· · · · · · · · ··JUDGE GOLDSTEIN:··Is there anything
11· · · ··before we start this morning?
12· · · · · · · · ··MS. HUYSER:··Nothing from us, Your Honor.
13· · · · · · · · ··MR. RUSSELL:··Nothing from Viridis, Your
14· · · ··Honor.
15· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Ms. Huyser,
16· · · ··I believe we left off the hearing with you.··You
17· · · ··were questioning Ms. Patterson; is that correct?
18· · · · · · · · ··MS. HUYSER:··Yes, sir.
19· · · · · · · · ··JUDGE GOLDSTEIN:··All right.
20· · · ··Ms. Patterson, because it is a new hearing day I'm
21· · · ··going to re-swear you as a witness.··Could you
22· · · ··raise your right hand?
23· · · · · · · · ··Do you solemnly swear or affirm to tell
24· · · ··the truth, the whole truth, and nothing but the
25· · · ··truth?··Can't hear you.

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·1· · · · · · · · ··MS. PATTERSON:··I do.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··I think your earphones
·3· · · ··are cutting your sound a bit.··Whatever that device
·4· · · ··is we didn't hear your answer.
·5· · · · · · · · ··Anybody else experiencing that issue?
·6· · · · · · · · ··MR. RUSSELL:··Yes.
·7· · · · · · · · ··MS. PATTERSON: I do.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Still having that
·9· · · ··issue.
10· · · · · · · · ··MS. HUYSER:··I think it's when she first
11· · · ··talks it's a little quieter, but the more she talks
12· · · ··it . . .
13· · · · · · · · ··JUDGE GOLDSTEIN:··Right.··I'm not sure
14· · · ··why it's doing that.
15· · · · · · · · ··Go ahead and raise your right hand again.
16· · · ··Do you solemnly swear or affirm to tell the truth,
17· · · ··the whole truth, and nothing but the truth?
18· · · · · · · · ··MS. PATTERSON:··I do.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Yeah, it's the
20· · · ··same issue as yesterday.··As you start to speak,
21· · · ··your voice comes in very clear, but initially it
22· · · ··hesitates for some reason and we don't hear it as
23· · · ··well.
24· · · · · · · · ··THE WITNESS:··I apologize.··Let me know
25· · · ··if it continues.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Now your voice
·2· · · ··just came in clear as you continued to talk.··The
·3· · · ··"I do" was kind of faint.··So -- all right.
·4· · · · · · · · ··THE WITNESS:··Thank you, sir.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Ms. Huyser, go ahead.
·7· · · · · · · ··DIRECT EXAMINATION, CONTINUING
·8· ·BY MS. HUYSER:
·9· ·Q· ··I know you provided a lot of information yesterday,
10· · · ··and we kind of were getting to the point to where
11· · · ··we were just about wrapping up.
12· · · · · · · · ··So reflecting on your testimony and all
13· · · ··of the information that you had provided yesterday
14· · · ··do you believe that either laboratory is using the
15· · · ··appropriate analytical testing methodologies
16· · · ··required for any safety tests that have been
17· · · ··validated by a third party?
18· ·A· ··I do not.
19· ·Q· ··And can you tell us why, please.
20· ·A· ··Specifically as it relates to the potency analyses,
21· · · ··microbial analyses, foreign matter, and
22· · · ··additionally some of the quality management
23· · · ··standard operating procedures I believe that there
24· · · ··has been significant evidence that we have
25· · · ··collected from the Agency that they have not been

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·1· · · ··following these procedures at least as far as we've
·2· · · ··been able to witness throughout the course of time
·3· · · ··as well as during on-site audits.
·4· ·Q· ··And can you give some examples about the quality
·5· · · ··assurance portion that you were talking about?
·6· ·A· ··In terms of the quality assurance portion, we
·7· · · ··discussed this a little bit yesterday, but in their
·8· · · ··own quality management standard operating
·9· · · ··procedures essentially they state that there will
10· · · ··be some quality manager in that laboratory space
11· · · ··typically designated to the CSO or the laboratory
12· · · ··director who will oversee operations and ensure
13· · · ··that, first of all, all of the methods are being
14· · · ··performed according to the standard operating
15· · · ··procedures that are approved by the Agency.··We
16· · · ··know that that's not being done based on the
17· · · ··evidence that we've collected.
18· · · · · · · · ··Additionally, I have concerns that
19· · · ··they're not following their quality management
20· · · ··procedures because they also state that if there's
21· · · ··any nonconforming work, for example, as we saw with
22· · · ··the microbial tests that were outside of the range
23· · · ··of temperature and were not recorded for the range
24· · · ··of time specified in the vendor manufacturer
25· · · ··specifications, that work should be flagged by this

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·1· · · ··manager, the director, the operator, whomever is
·2· · · ··designated to do that.··And in this case it's very
·3· · · ··frequently Michele Glinn at Viridis Lansing
·4· · · ··Laboratories and it is Michael LaFramboise at
·5· · · ··Viridis North Laboratories.
·6· · · · · · · · ··Because we know that these items have not
·7· · · ··been flagged and they've not been followed up on
·8· · · ··internally, I believe that they're not following
·9· · · ··those procedures and they're not doing their duties
10· · · ··as laboratory managers to provide the appropriate
11· · · ··oversight to ensure that the laboratory is
12· · · ··reporting accurate and precise results to their
13· · · ··clients and ultimately to the consumers of these
14· · · ··products in Michigan.
15· ·Q· ··The recent investigations or the recent concerns
16· · · ··that you have had, were those or are those the
17· · · ··only -- the first concerns or the only concerns
18· · · ··that you've ever had with Viridis following rules
19· · · ··and regulations pertaining to safety and testing
20· · · ··procedures?
21· ·A· ··No, they are not.
22· ·Q· ··When else have you --
23· · · · · · · · ··MR. RUSSELL:··Objection to foundation.
24· · · ··When you say recent, what are you talking about?
25· · · · · · · · ··MS. HUYSER:··Recent going back to the

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·1· · · ··testimony that's been provided not so -- that is
·2· · · ··the subject matter of this proceeding.
·3· · · · · · · · ··MR. RUSSELL:··So you're talking about the
·4· · · ··time frame set forth in the superseding complaint?
·5· · · · · · · · ··MS. HUYSER:··Yes, I was, as a reference
·6· · · ··point.··Now we're going back to -- the question was
·7· · · ··was there anything preceding that.
·8· ·Q· ··(MS. HUYSER) So, Ms. Patterson, was there anything
·9· · · ··preceding that?
10· ·A· ··There was.··We have had a couple of issues in the
11· · · ··past at Viridis again not following what was
12· · · ··approved for them for their SOPs as well as not
13· · · ··following various portions of the administrative
14· · · ··rules that were in play at that time.
15· ·Q· ··And can you provide an example of a time where you
16· · · ··actually had to or was there ever a time where you
17· · · ··had -- where a complaint had to be filed?
18· ·A· ··Yes, there were I believe two specific instances
19· · · ··where a complaint had to be filed due to those
20· · · ··reasons.
21· · · · · · · · ··MR. RUSSELL:··I'm going to object.··This
22· · · ··testimony is inappropriate.··This isn't part of the
23· · · ··superseding complaint or the necessary business
24· · · ··disruption complaint.
25· · · · · · · · ··I'm not sure why the witness would be

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·1· · · ··testifying to allegations that they're not set
·2· · · ··forth in the superseding complaint other than to
·3· · · ··create some bias in -- against Viridis North and
·4· · · ··Viridis Laboratories.
·5· · · · · · · · ··MS. HUYSER:··Actually, Number 7
·6· · · ··references exactly what we're talking about, and
·7· · · ··that is a factual allegation contained in the
·8· · · ··superseding complaint.
·9· · · · · · · · ··MR. RUSSELL:··You're using it is as MRA
10· · · ··404 propensity evidence.
11· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Are you
12· · · ··talking about the prior consent order that's
13· · · ··referenced --
14· · · · · · · · ··MS. HUYSER:··Yes.
15· · · · · · · · ··JUDGE GOLDSTEIN:··-- in the complaint?
16· · · ··Okay.
17· · · · · · · · ··And is that what this question relates
18· · · ··to?
19· · · · · · · · ··MS. HUYSER:··Yes.
20· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··And for what
21· · · ··purpose are you covering -- or are you questioning
22· · · ··this witness on this for?
23· · · · · · · · ··MS. HUYSER:··For the -- in the consent
24· · · ··order -- this happened, obviously, before this --
25· · · ··but in the consent order part of the agreement with

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·1· · · ··the resolution was to make sure that they were
·2· · · ··aware of the rules, the regulations, and being
·3· · · ··compliant.
·4· · · · · · · · ··So this demonstrates that they had a
·5· · · ··background of dealing with the CRA, a background of
·6· · · ··pointing out violations and having conversations
·7· · · ··about how to resolve them.··And part of that was in
·8· · · ··a reminder that you have to be compliant with the
·9· · · ··rules and follow the rules.
10· · · · · · · · ··MR. RUSSELL:··That's exactly the purpose
11· · · ··behind the MRA 404 is -- and Ms. Huyser's now
12· · · ··testified.
13· · · · · · · · ··JUDGE GOLDSTEIN:··Prior bad acts
14· · · ··evidence?
15· · · · · · · · ··MS. HUYSER:··Yes.
16· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Well, I'll
17· · · ··allow the question in and give it whatever weight
18· · · ··it deserves.
20· ·Q· ··(MS. HUYSER) Are you -- I'm just going to put on
21· · · ··the screen, we'll simplify this, what has been
22· · · ··marked as CRA's proposed Exhibit 50.
23· · · · · · · · ··MS. HUYSER:··Can you allow me to share
24· · · ··screen?··Sorry.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Oops.··Did it -- it

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·1· · · ··did.··It stopped overnight I guess.··Sorry about --
·2· · · ··now you're fine.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Yep.
·5· ·Q· ··(MS. HUYSER) Ms. Patterson, can you see what is on
·6· · · ··the screen?
·7· ·A· ··Yes, I can.
·8· ·Q· ··And do you -- I'll scroll down slowly.··Take an
·9· · · ··opportunity to look at it, and tell me if you
10· · · ··recognize what it is.
11· · · · · · · · ··MR. RUSSELL:··I was unable to hear the
12· · · ··witness's answer to that question.
13· · · · · · · · ··THE WITNESS:··Yes, I do recognize this.
14· ·Q· ··(MS. HUYSER) And what do you recognize this to be?
15· ·A· ··This is a consent order and stipulation related to
16· · · ··those matters that I was just referencing.
17· ·Q· ··And, obviously, you recognize it by the contents of
18· · · ··the document?
20· ·Q· ··And you have seen it before?
22· ·Q· ··Have there been any changes to it in the form that
23· · · ··you have recently seen or have seen it at all?
24· ·A· ··No, there have not.

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·1· · · ··Honor, we're going to ask that CRA proposed Exhibit
·2· · · ··50 be admitted.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, any objection?
·4· · · · · · · · ··MR. RUSSELL:··No, Judge.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··CRA Exhibit 50 is
·7· · · · · · · · ··(CRA Exhibit 50 is admitted.)
·8· ·Q· ··(MS. HUYSER) Did -- when you have an opportunity or
·9· · · ··when you review, or have you reviewed this, let me
10· · · ··back up.
12· ·Q· ··And what was the terms of the agreement that were
13· · · ··set forth here, in your own words?
14· ·A· ··In my own words I believe specifically the terms of
15· · · ··the agreement were that Viridis Laboratories would
16· · · ··be responsible of making themselves familiar with
17· · · ··the applicable statutes and administrative rules
18· · · ··and that they would review them, ensure that they
19· · · ··understood them, and then I believe that they
20· · · ··essentially agreed to follow those rules moving
21· · · ··forward, particularly as it related to their rules
22· · · ··and as a licensee or a licensed laboratory here in
23· · · ··the state of Michigan.
24· ·Q· ··And what type of, in general, without having to go
25· · · ··into significant detail, what type of issues

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·1· · · ··brought about the necessity for this consent order?
·2· ·A· ··There were two separate issues.··The first was the
·3· · · ··fact that Viridis Laboratories began testing for
·4· · · ··heavy metals in a concentrate matrix without having
·5· · · ··the appropriate Agency approval to do so.··And that
·6· · · ··was particularly interesting because we had
·7· · · ··actually discussed with them prior to this
·8· · · ··investigation and them reporting and testing on
·9· · · ··this unapproved method and let them know what they
10· · · ··needed to do to become approved in order to test
11· · · ··for heavy metals in a concentrate matrix.
12· · · · · · · · ··They had not fulfilled those
13· · · ··requirements, and yet they went on to test heavy
14· · · ··metals without the appropriate approvals in the
15· · · ··concentrate matrix.··And we had to make sure to
16· · · ··circle back with them and notify them again of what
17· · · ··they needed to do in order to receive those
18· · · ··approvals and that they were not permitted to do so
19· · · ··until those approvals were received accordingly.
20· · · · · · · · ··Additionally, there was a violation
21· · · ··related to not maintaining laboratory samples for
22· · · ··the requisite 30 days.··And I believe that those
23· · · ··rules went into effect of June -- or in June of
24· · · ··2020.··And at this point in time I believe it was
25· · · ··October of 2020 that they still were not

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·1· · · ··maintaining the appropriate samples which, of
·2· · · ··course, was concerning because that gives about
·3· · · ··four months of time that it was apparent that they
·4· · · ··hadn't read or informed themselves of the
·5· · · ··applicable administrative rules that were in effect
·6· · · ··at that time.
·7· ·Q· ··Were they ultimately able to get the approval to
·8· · · ··test heavy metals and concentrates?
·9· ·A· ··They were.
10· ·Q· ··And is that the similar process to what you have to
11· · · ··get an approval for any type of standard operating
12· · · ··procedure?
13· ·A· ··It is.
14· · · · · · · · ··MS. HUYSER:··Thank you.··At this point in
15· · · ··time I have nothing further.
16· · · · · · · · ··JUDGE GOLDSTEIN:··Cross-examination,
17· · · ··Counsel?
18· · · · · · · · ··MR. RUSSELL:··Yes.··Thank you, Your
19· · · ··Honor.
20· · · · · · · · · · ··CROSS-EXAMINATION
21· ·BY MR. RUSSELL:
22· ·Q· ··Good morning, Ms. Patterson.
23· ·A· ··Good morning.
24· ·Q· ··I noticed that a couple times you were referenced
25· · · ··as Doctor.··I think Ms. Huyser did initially, and I

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·1· · · ··heard it this morning as well.
·2· · · · · · · · ··Are you a doctor?··Do you have a -- do
·3· · · ··you hold a doctorate?
·4· ·A· ··No, sir, I do not.··And I apologize, I did not hear
·5· · · ··her reference me that way.
·6· ·Q· ··I believe you testified yesterday at the beginning
·7· · · ··of your testimony that the marijuana industry back
·8· · · ··in 2019 was the Wild Wild West.··I think that's how
·9· · · ··you referred to it.··Is that correct?
11· ·Q· ··Okay.··And would it be fair to say that when the
12· · · ··CRA started it started with very few employees and
13· · · ··that new procedures were continuously being adopted
14· · · ··or changed from 2019 to the present?
15· ·A· ··I wouldn't say from 2019 to the present, I would
16· · · ··say very early on, approximately 2018 to very early
17· · · ··in 2020, those were being adopted.
18· · · · · · · · ··Of course, with any group we're going to
19· · · ··continue to adopt new procedures and add ones as
20· · · ··necessary, but primarily I would say those
21· · · ··beginning stages were 2018 to very early in 2020.
22· ·Q· ··Do you know in 2019 how many employees that the CRA
23· · · ··had?
24· ·A· ··No, sir, I do not.
25· ·Q· ··Is it more than 10?

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·1· ·A· ··It was more than 10.
·2· ·Q· ··Is it more than 20?
·3· ·A· ··I would venture to guess, but I cannot verify that.
·4· ·Q· ··You testified yesterday that the CRA has a formal
·5· · · ··procedure for approval of methods; is that correct?
·6· ·A· ··Yes, sir.
·7· ·Q· ··Okay.··And you recall you were deposed in this
·8· · · ··matter; correct?
·9· ·A· ··I don't recall exactly, but I believe it to be true
10· · · ··if you're telling me this now.
11· ·Q· ··That you were deposed?··You don't recall me
12· · · ··deposing you in this matter?
13· ·A· ··No, I do recall being deposed in this matter.··I
14· · · ··thought you were referencing in methods
15· · · ··specifically.
16· ·Q· ··Well, that's what I was going to ask you next.
17· · · · · · · · ··Do you recall in that testimony that you
18· · · ··testified that there was a time when approvals for
19· · · ··SOPs were sent via email?
20· ·A· ··Yes, sir.
21· ·Q· ··Okay.··So as opposed to this form, this method
22· · · ··approval form, that you testified to yesterday,
23· · · ··there was a time where it was done just via email?
24· ·A· ··Yes, there was a time before this approval form was
25· · · ··in place that they were sent only via email.··But,

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·1· · · ··to clarify, these are also sent via email.
·2· ·Q· ··I guess my understanding of your testimony
·3· · · ··previously, though, was that there was no approval
·4· · · ··form initially, that it was just via email and that
·5· · · ··the approval form came later?
·6· ·A· ··That's true.
·7· ·Q· ··And in 2021 you were the scientific manager
·8· · · ··overseeing the CRA lab scientists; is that correct?
·9· ·A· ··Yes, sir.
10· ·Q· ··Okay.··And is it true that you had the least
11· · · ··education out of the CRA lab scientists?
12· ·A· ··Yes, sir, in terms of formal education, that is
13· · · ··true.
14· ·Q· ··Okay.··And is it true that you have less education
15· · · ··than Dr. Michele Glinn, the chief science officer
16· · · ··at Viridis?
17· ·A· ··Relevant education I'm not sure.··I can't speak to
18· · · ··that.
19· ·Q· ··You're aware that she has a doctorate?
20· ·A· ··I am aware now that you've told me.
21· ·Q· ··You weren't aware before today?
22· ·A· ··To be frank with you, I don't look at Dr. Glinn's
23· · · ··CV very frequently.
24· ·Q· ··The CRA doesn't have its own lab; correct?

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·1· ·Q· ··Okay.··And so therefore the CRA scientists never
·2· · · ··actually test cannabis themselves while working for
·3· · · ··the CRA; correct?
·4· ·A· ··While working for the CRA that is correct.
·5· ·Q· ··Okay.··So the CRA relies on the safety compliance
·6· · · ··facilities to conduct any testing that it wants
·7· · · ··done; correct?
·8· ·A· ··Yes, sir.
·9· ·Q· ··Okay.··So then you actually have no way to train
10· · · ··laboratory scientists, or I believe you referred to
11· · · ··them as LSSs, in a lab setting; correct?
12· ·A· ··I have no way to train them specifically; however,
13· · · ··our qualifications for employment as a laboratory
14· · · ··scientist specialist are incredibly high and do
15· · · ··require specific laboratory experience as well as
16· · · ··education.
17· ·Q· ··Okay.··So let's take Dr. Chirio for example.··I
18· · · ··believe she testified that she had never personally
19· · · ··tested cannabis.··Would that be true?
20· ·A· ··If she said that was true, I believe it to be true.
21· ·Q· ··Okay.··So what -- what qualifications would
22· · · ··Dr. Chirio have to be a lab scientist for the CRA?
23· ·A· ··So in order to be a laboratory scientist for the
24· · · ··CRA you have to have a combination of the
25· · · ··appropriate analytical and scientific background

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·1· · · ··and some sort of an advanced degree, either a
·2· · · ··master's or a doctorate degree, as well as relevant
·3· · · ··in-laboratory experience, either analytical or
·4· · · ··microbiological.··It may also be related to
·5· · · ··laboratory experience that oversees public health
·6· · · ··and safety testing.··So that is the case for
·7· · · ··Dr. Chirio as well as quality management, quality
·8· · · ··control, and oversight.
·9· ·Q· ··Is it fair to say that the CRA is tasked with
10· · · ··making sure that safety compliance facilities are
11· · · ··using methods that produce accurate results?
12· ·A· ··Yes, sir.
13· ·Q· ··Okay.··Is it also fair to say that the goal is
14· · · ··public health and safety?
15· ·A· ··Yes, sir.
16· ·Q· ··And the three allegations in the superseding
17· · · ··complaint that we're here at least in part on,
18· · · ··those are related to actions that started or
19· · · ··happened in 2021; correct?
20· ·A· ··These actions started or happened actually in 2020
21· · · ··and then have run through the course of time until
22· · · ··current.
23· ·Q· ··Okay.··And those three allegations, I want to make
24· · · ··sure I'm understanding, relate to potency, foreign
25· · · ··matter, and microbial issues; correct?

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·1· ·A· ··As well as violations related to quality management
·2· · · ··and oversight.··But yes, sir, otherwise you are
·3· · · ··correct.
·4· ·Q· ··And is it true that these investigations for all
·5· · · ··those things that you just delineated were
·6· · · ··conducted, in part, by four CRA lab scientists,
·7· · · ··including yourself?
·9· ·Q· ··Okay.··So it would have been -- it would have been
10· · · ··you, Claire Patterson, Dr. Noah Rosenzweig, Patrice
11· · · ··Fields, and Allyson Chirio; is that correct?
13· ·Q· ··And isn't it true that Allyson Chirio had been
14· · · ··removed from overseeing Viridis Laboratories
15· · · ··because of her conduct at one point in time?
16· ·A· ··No, that is not correct.
17· ·Q· ··Okay.··And so it's your testimony here today that
18· · · ··she was never removed from overseeing Viridis
19· · · ··Laboratories?
20· ·A· ··No, sir, that is not what I testified to.
21· ·Q· ··Okay.··So you recall then again that you were
22· · · ··deposed in this case, and I believe your testimony
23· · · ··there was that she was removed because there was
24· · · ··some communications issues.··Is that correct?
25· ·A· ··I believe what I testified to is that she was

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·1· · · ··removed because we reallocated LSSs to the
·2· · · ··oversight of various laboratories at which point
·3· · · ··Dr. Rosenzweig and Dr. Fields were assigned.
·4· · · ··However, previously, when I returned back from
·5· · · ··maternity leave, I was given oversight of the
·6· · · ··Viridis Laboratories because it did seem that there
·7· · · ··were some communication issues between Viridis and
·8· · · ··Dr. Chirio.··So I jumped in to assist.··However,
·9· · · ··that reassignment was not done in any sort of
10· · · ··negative fashion, it was simply to ease
11· · · ··communications.
12· ·Q· ··And so if Kavita Kale were to testify that she
13· · · ··reassigned -- and let me, I guess, back up.
14· · · · · · · · ··You know who Kavita Kale is; correct?
15· ·A· ··Yes, sir, I do.
16· ·Q· ··Okay.··And Kavita Kale would have been the person
17· · · ··in your position that you hold now; is that right?
18· ·A· ··No, it is not.
19· ·Q· ··Okay.··Well, Kavita Kale would have made a
20· · · ··determination to reassign Allyson Chirio; is that
21· · · ··correct?
22· ·A· ··I do not believe so, no.
23· ·Q· ··It wasn't Kavita Kale that made a determination to
24· · · ··remove Allyson Chirio from oversight from Viridis?
25· ·A· ··First of all I can't speak to whether that decision

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·1· · · ··was made or was not as I have no knowledge of
·2· · · ··removing her from that position; however, anyone
·3· · · ··who would have made that position would have been
·4· · · ··the manager of the LSSs at that time, and that was
·5· · · ··not Director Kale.
·6· ·Q· ··What do you mean you have no knowledge of it?··You
·7· · · ··just testified that it wasn't because of any
·8· · · ··behavioral issues.
·9· ·A· ··I can't speak to who decided to do that.
10· · · · · · · · ··I was asked to overseeing Viridis to
11· · · ··improve communications.··I don't know that anyone
12· · · ··was removed necessarily, all I know is that I was
13· · · ··assigned.
14· ·Q· ··And you were actually on maternity leave at that
15· · · ··time that she was removed as the laboratory
16· · · ··scientist overseeing Viridis Laboratories; correct?
17· ·A· ··I can't speak to that.··It doesn't make sense that
18· · · ··Viridis would not be assigned an LSS.··And in my
19· · · ··absence there would have only been one LSS
20· · · ··available and that would have been Dr. Chirio.
21· ·Q· ··So at that time, then, when you were on maternity
22· · · ··leave there were only two LSSs, is that your
23· · · ··testimony?
25· ·Q· ··Okay.··And so what was that time frame that you

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·1· · · ··were on maternity leave?
·2· ·A· ··I was on maternity leave from August of 2019
·3· · · ··through mid-November of 2019.
·4· ·Q· ··And I believe you testified yesterday that at the
·5· · · ··beginning the relationship between the CRA and the
·6· · · ··two Viridis laboratories was a good relationship.
·7· · · ··Is that what you testified?
·8· ·A· ··Yes.
·9· ·Q· ··Okay.··Were you aware that Allyson Chirio, even
10· · · ··prior to the two Viridis laboratories receiving
11· · · ··licenses, had expressed that she believed that the
12· · · ··owners, these former Michigan State police
13· · · ··officers, from the Michigan State crime lab were
14· · · ··not qualified to run laboratories?
15· ·A· ··I can't speak to what happened before my employment
16· · · ··at the CRA.
17· ·Q· ··Did you ever hear that from anyone after you began
18· · · ··your employment at the CRA?
19· ·A· ··No.
20· ·Q· ··Were you ever made aware that Allyson Chirio early
21· · · ··on on one of the site visits to Viridis
22· · · ··Laboratories had actually threatened to put one of
23· · · ··the owners in jail?
24· ·A· ··No.
25· ·Q· ··You never heard that?

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·1· ·A· ··No.
·2· ·Q· ··Were you aware after Dr. Chirio was removed from
·3· · · ··oversight of an email that Allyson Chirio sent
·4· · · ··internally that alleged that Kavita Kale was having
·5· · · ··an inappropriate relationship with someone from
·6· · · ··Viridis?
·7· ·A· ··Not that I can recall, no.
·8· ·Q· ··You don't recall any discussions about that?
·9· ·A· ··Not regarding an inappropriate relationship, no,
10· · · ··sir.
11· ·Q· ··Okay.··Did you become aware that Julie Kluytman had
12· · · ··filed a complaint against Allyson Chirio with HR
13· · · ··because of some communication that was sent out by
14· · · ··Allyson Chirio related to Kavita Kale and the two
15· · · ··Viridis laboratories?
16· ·A· ··Not that I recall, sir, no.
17· ·Q· ··Would you agree if such an email was sent out to
18· · · ··CRA officials that that would be inappropriate?
19· ·A· ··I can't speak to that without knowing exactly what
20· · · ··it is you're talking about.
21· ·Q· ··In addition to the investigations that you talked
22· · · ··about the four laboratory scientists being involved
23· · · ··in during I think you said 2020 to the present,
24· · · ··which clearly from your testimony there's been
25· · · ··nonstop investigations, were Desmond Mitchell and

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·1· · · ··Julie Kluytman also involved in those
·2· · · ··investigations?
·3· ·A· ··So Director Kluytman and Director Mitchell or --
·4· · · ··well, Manager Kluytman at some point in that time
·5· · · ··do not conduct investigations.··They are involved
·6· · · ··as it potentially moves up the chain through, you
·7· · · ··know, various legal approvals and things of that
·8· · · ··nature, but those folks do not perform
·9· · · ··investigations at our Agency.··That's not how the
10· · · ··workflow goes.
11· ·Q· ··And maybe I wasn't clear, but my question wasn't
12· · · ··whether they were performing investigations, I want
13· · · ··to know if they were involved with your
14· · · ··investigations in any way.
15· ·A· ··Other than being aware of the fact that they
16· · · ··existed, no.··But yes, they were aware of the fact
17· · · ··that they existed, at least adjacently.
18· ·Q· ··But there would have been emails to Desmond
19· · · ··Mitchell and Julie Kluytman and, frankly, Andrew
20· · · ··Brisbo as well asking for guidance on how to move
21· · · ··forward with the investigations; correct?
22· ·A· ··Certainly on some investigations that's true.
23· ·Q· ··Okay.··So at least in some manner they were
24· · · ··involved in the investigations of how to proceed;
25· · · ··is that correct?

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·1· ·A· ··Certainly.
·2· ·Q· ··Okay.··So would it be fair to say during the time
·3· · · ··frame that we're talking about there were at least
·4· · · ··seven CRA officials that were involved in
·5· · · ··investigations of the two Viridis laboratories, at
·6· · · ··least in some manner?
·7· ·A· ··Can you please clarify which seven individuals
·8· · · ··you're referring to?
·9· ·Q· ··I'm talking about the four laboratory scientists.
10· · · ··I'm talking about Julie Kluytman, Desmond Mitchell,
11· · · ··and Andrew Brisbo.
12· ·A· ··I can speak to all of those except for Director
13· · · ··Brisbo.··I'm not certain about that piece of it.
14· · · ··Former Director Brisbo I should add.
15· ·Q· ··And would it be fair to say that Brian Hanna was
16· · · ··also involved in investigations?
17· ·A· ··Yes, at that time he was a manager he may have in
18· · · ··some part been involved, but I'm not sure how much
19· · · ··he would have been involved as he was the manager
20· · · ··of the field operations section.··So there was very
21· · · ··little involvement, if any.
22· ·Q· ··So at a minimum I think you just testified then
23· · · ··there were eight folks from the CRA that were
24· · · ··involved in these investigations?
25· ·A· ··Again, I can't speak to former Director Brisbo,

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·1· · · ··but, as you mentioned -- well, now Director Hanna,
·2· · · ··he may have been involved adjacently, but also I
·3· · · ··cannot speak to his involvement.
·4· ·Q· ··And would there have been other officials at the
·5· · · ··CRA that were involved in, say, compiling Metrc
·6· · · ··data?
·7· ·A· ··Yes, there were other individuals at the CRA or
·8· · · ··there are currently other individuals at the CRA
·9· · · ··who are responsible for compiling Metrc data, yes.
10· ·Q· ··Okay.··And can you tell us who those folks are?
11· ·A· ··Typically those folks are the individual data
12· · · ··analysts that are in the operations support
13· · · ··section.
14· ·Q· ··Are they CRA employees?
15· ·A· ··They are CRA employees, yes.
16· ·Q· ··Okay.··And would it be fair to say that you were
17· · · ··getting information from those folks in order to
18· · · ··provide or to make determination on potency levels,
19· · · ··fail rates, things of that nature?
20· ·A· ··We do request that they use their knowledge of data
21· · · ··analytics to pull that information down from Metrc
22· · · ··as it is entered, yes.
23· ·Q· ··So do you know how many people in the CRA are --
24· · · ··would be included in those -- those analysts that
25· · · ··provided that information?

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·1· ·A· ··In order to actually pull that data down there are
·2· · · ··typically two analysts in the operations support
·3· · · ··section at any time.··Going through the course of
·4· · · ··time that's relevant to this complaint I would say
·5· · · ··there are three separate individuals who have that
·6· · · ··capability.··Possibly -- no, three.
·7· ·Q· ··And what are their names?
·8· ·A· ··Their names are Garrett Shireman, Dan Flores I
·9· · · ··believe was his name -- he was here for a brief
10· · · ··period of time -- and then currently Matt.··His
11· · · ··last name starts with a K, and I apologize because
12· · · ··I cannot recall his full last name.
13· ·Q· ··You mentioned Dan Flores.··Was Dan Flores a CRA
14· · · ··employee?
15· ·A· ··Yes, he was.
16· ·Q· ··Okay.··And at some point did he leave the CRA to
17· · · ··work in another division at LARA?
18· ·A· ··I do not know where he went.
19· ·Q· ··Okay.··Maybe that was a poor question.
20· · · · · · · · ··After he left the CRA was he in a
21· · · ··position where you would request Metrc data from
22· · · ··him?
23· ·A· ··I believe that there is a period of time where Dan
24· · · ··was working with both the CRA as well as wherever
25· · · ··else he may have gone.··There was some agreement

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·1· · · ··between HR and the appropriate managers during that
·2· · · ··transition period where he spent or split time
·3· · · ··between wherever he went and the CRA.
·4· ·Q· ··And is it true that -- or do you recall requesting
·5· · · ··Dan Flores when he was in this, I guess, dual role,
·6· · · ··requesting Metrc data as it related to aspergillus?
·7· ·A· ··I may have during that time.··I can't speak to the
·8· · · ··exact time period, but if we needed data and he was
·9· · · ··in that transition period we would have absolutely
10· · · ··tapped him for that information.
11· ·Q· ··And then when you -- you being in your position,
12· · · ··would you personally receive the data and make the
13· · · ··analysis yourself?
14· ·A· ··I would personally receive the data, yes.··There
15· · · ··were some occasions where I would make the analysis
16· · · ··myself, but typically I would give that analysis to
17· · · ··my LSS team, primarily Dr. Rosenzweig because he
18· · · ··has an immense background in statistical analyses.
19· · · ··And if I ever did perform those analyses by myself
20· · · ··I would typically have Noah review them because he
21· · · ··is well versed in statistical analyses.
22· ·Q· ··So I'm trying to understand the procedure.··So you
23· · · ··request Metrc data, let's say Metrc data that comes
24· · · ··from Dan Flores.··And if you were to give that to
25· · · ··Noah Rosenzweig to analyze that, would you, after

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·1· · · ··you have received some kind of report from him,
·2· · · ··would you go back and would you review the
·3· · · ··underlying data itself or would you just review the
·4· · · ··report?
·5· ·A· ··I would look at both so that I could see both the
·6· · · ··data provided as well as the reported analyses.
·7· ·Q· ··Okay.··So just to be clear, then, you would confirm
·8· · · ··any type of report that was created that the
·9· · · ··underlying data was correct in that report, is that
10· · · ··what your testimony is?
11· ·A· ··To the best of my ability, yes, with the knowledge
12· · · ··that I am not the individual pulling that data from
13· · · ··Metrc.··So I can't speak to the quality of the
14· · · ··data, you know, the type of data pull, any of that
15· · · ··information; however, the individuals that are
16· · · ··tasked with doing that are hired because of their
17· · · ··ability to do that data analysis from Metrc.
18· ·Q· ··And you would agree if the analysis of the Metrc
19· · · ··data was manipulated by CRA employees to further an
20· · · ··investigation that would be highly inappropriate;
21· · · ··correct?
22· ·A· ··If that were true, that would be correct, yes.
23· ·Q· ··But you've testified now that you reviewed all the
24· · · ··underlying data and so you know that that was not
25· · · ··correct, it wasn't manipulated in any way?

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·1· ·A· ··To my knowledge the CRA has never manipulated data
·2· · · ··ever.
·3· ·Q· ··And as the manager would you agree that that would
·4· · · ··be one of your job duties to confirm that data
·5· · · ··wasn't being manipulated?
·6· ·A· ··Yes.
·7· ·Q· ··And Allyson Chirio, she analyzed data for the CRA
·8· · · ··as well; is that correct?
·9· ·A· ··Not typically, no.
10· ·Q· ··So is it your testimony that she never analyzed
11· · · ··data?
12· ·A· ··No.··I said not typically, sir.
13· ·Q· ··Okay.··As it relates to the investigations to
14· · · ··Viridis North and Viridis Laboratories do you
15· · · ··recall a time when Allyson Chirio had analyzed
16· · · ··data?
17· ·A· ··She may have looked at raw data, yes.
18· ·Q· ··Okay.··As it relates to potency?
19· ·A· ··Potentially, likely, yes.
20· ·Q· ··Okay.··And as it relates to microbial?
21· ·A· ··Again, likely, yes.
22· ·Q· ··Okay.··So the answer is yes on both.··Allyson
23· · · ··Chirio would have been involved in analyzing data;
25· ·A· ··In looking at raw data, sir, to clarify.

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·1· ·Q· ··Okay.··So is it your testimony then that Allyson
·2· · · ··Chirio would never have created any reports based
·3· · · ··on that raw data?
·4· ·A· ··She may have created reports, but our process here
·5· · · ··at the CRA when we have data to review is that we
·6· · · ··may review the raw data, but because we have a team
·7· · · ··of LSSs, we rely on one another to double-check
·8· · · ··data, to fact check one another, to run statistical
·9· · · ··analyses, and then to run that information through
10· · · ··the manager, which of course is myself.
11· ·Q· ··Viridis North and Viridis Laboratories are both
12· · · ··accredited by the A2LA; correct?
14· ·Q· ··And would it be fair to say that the accreditation
15· · · ··is a review of all of their SOPs and validations
16· · · ··and that they're complying with their ISO
17· · · ··requirements?
18· ·A· ··No, their accreditation is simply a high-level
19· · · ··review of whether or not they comply with their ISO
20· · · ··requirements.
21· ·Q· ··So if -- and Chris Gunning will testify -- but when
22· · · ··Chris Gunning testifies that the A2LA comes in and
23· · · ··they review the SOPs and the validations for the
24· · · ··methods that they use, that testimony will be
25· · · ··inaccurate?

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·1· ·A· ··They may be reviewing that information, but they do
·2· · · ··not review that as it relates to the regulatory
·3· · · ··body and the SOPs that are related to the
·4· · · ··regulatory body.
·5· ·Q· ··That wasn't my -- that wasn't my question though.
·6· · · ··My question was that are you aware that they come
·7· · · ··in and they review that for accuracy.
·8· ·A· ··I do not believe they review it for accuracy, no.
·9· · · ··They review it to ensure that it is in alignment
10· · · ··with the ISO 17025 accreditation requirements.
11· ·Q· ··So I just want to be clear then.··So when Chris
12· · · ··Gunning from the A2LA comes in and testifies that
13· · · ··they do review the SOPs and the validations that
14· · · ··that testimony will be incorrect?
15· ·A· ··You just stated that they review it for accuracy.
16· · · ··You're stating two separate things.··Can you please
17· · · ··clarify, sir?
18· ·Q· ··Yes.··Stating for accuracy, correct.··Reviewing for
19· · · ··accuracy.
20· ·A· ··Accuracy is --
21· ·Q· ··That the tests produce reliable results.
22· ·A· ··According to what standards?
23· ·Q· ··Whatever their standards are that they review.··I'm
24· · · ··not going to provide you with their standards, I'm
25· · · ··saying that they come in and review as an

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·1· · · ··accrediting body that the SOPs are in place and the
·2· · · ··validations are in place and that they produce
·3· · · ··reliable results.
·4· ·A· ··I will agree that they review those SOPs and those
·5· · · ··requirements in the laboratory as it relates to ISO
·6· · · ··17025 accreditation standards, yes.
·7· ·Q· ··That wasn't my question.··My question was not just
·8· · · ··as to the ISO accreditation standards but also just
·9· · · ··to the SOP being filed, the validation being
10· · · ··complete, and that it produces reliable results.
11· ·A· ··I can say in the case of A2LA and Viridis they
12· · · ··clearly did not review that.··Whether or not
13· · · ··they're supposed to, I can't speak to that.
14· ·Q· ··"They clearly did not review that."··You're talking
15· · · ··about the A2LA?
16· ·A· ··Yes, sir.
17· ·Q· ··And you're basing that off the fact that they
18· · · ··were -- their accreditation was approved; correct?
19· ·A· ··No, I'm basing that based on the investigations
20· · · ··that we have as the regulatory body where we
21· · · ··identify that the licensee is not following their
22· · · ··standard operating procedure as they are approved
23· · · ··and written.
24· ·Q· ··So what you're testifying then is that you
25· · · ··disagreed with the assessment that was made by the

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·1· · · ··A2LA?
·2· ·A· ··If that is what they're basing that assessment on,
·3· · · ··yes, I am disagreeing with that.
·4· ·Q· ··And you testified that the accreditation
·5· · · ··accreditates the fact -- I believe this is what you
·6· · · ··stated -- you testified that they're accrediting --
·7· · · ··that they're complying with ISO requirements;
·8· · · ··correct?
10· ·Q· ··Okay.··So you would agree that the A2LA has done
11· · · ··that?
12· ·A· ··In the case of Viridis Laboratories it did seem
13· · · ··that some of that information was lacking.··But I
14· · · ··do agree that that is A2LA's job, and it is the
15· · · ··auditor's job to audit the laboratory as it relates
16· · · ··to the ISO 17025 requirements.
17· ·Q· ··But, to be clear, the CRA doesn't do that; correct?
18· · · ··That's why the accreditation is required in the
19· · · ··rules; right?
20· ·A· ··That is true.
21· ·Q· ··Okay.··So the CRA, it's not part of the CRA's
22· · · ··regulatory job to make a determination of whether a
23· · · ··laboratory is complying with the ISO requirements?
24· ·A· ··Correct, it is our job to ensure that a laboratory
25· · · ··is meeting the requirements of the Cannabis

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·1· · · ··Regulatory Agency and the statutes and applicable
·2· · · ··rules.
·3· ·Q· ··Right.··The accreditation or the determination on
·4· · · ··ISO compliance is the job of the accreditation
·5· · · ··body; correct?
·6· ·A· ··Agreed.
·7· ·Q· ··Okay.··And so would it be fair to say or a true
·8· · · ··statement that A2LA accredited both Viridis North
·9· · · ··and Viridis Laboratories that they were complying
10· · · ··with ISO requirements, that they have since the
11· · · ··beginning?
12· ·A· ··I can't speak to their compliance; however, I can
13· · · ··agree that A2LA accredited them and provided that
14· · · ··certification.
15· ·Q· ··Okay.··And would you agree once they accredited
16· · · ··them and provided that certification that's what
17· · · ··the CRA's required to rely on is the accrediting
18· · · ··body giving them the accreditation?··That's -- the
19· · · ··CRA doesn't come in and make a separate
20· · · ··investigation into ISO compliance; correct?
21· ·A· ··If we identify that there are noncompliances
22· · · ··related to ISO, and back to our administrative
23· · · ··rules we may.··But no, I agree with you.··It is ISO
24· · · ··and their auditors' requirements that the
25· · · ··laboratory is required to meet in order to receive

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·1· · · ··that certification.
·2· ·Q· ··And you're not actually qualified to make a
·3· · · ··determination of whether a laboratory is meeting
·4· · · ··ISO requirements; is that correct?
·5· ·A· ··I have been trained as an ISO auditor, and I have
·6· · · ··performed ISO audits previously.
·7· ·Q· ··And you were trained by Susan Audino; is that
·8· · · ··correct?
·9· ·A· ··I was trained by Susan Audino and I was trained
10· · · ··previously when I was performing ISO accreditation
11· · · ··oversight for Iron Laboratories.
12· ·Q· ··Okay.··And would you -- would you describe Susan
13· · · ··Audino as an expert?
14· ·A· ··No.··Can you be more clear in what you mean by
15· · · ··expert?
16· ·Q· ··Well, I think you just stated she trained you in
17· · · ··ISO.··Is that correct, or did I miss that?
18· ·A· ··You are correct in that, yes.
19· ·Q· ··Okay.··So were you trained by a scientist that was
20· · · ··not an expert in ISO requirements?
21· ·A· ··No.
22· ·Q· ··I'm confused.··When you --
23· ·A· ··I --
24· ·Q· ··-- say she is -- go ahead.
25· ·A· ··I was trained previously by an individual that was

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·1· · · ··employed by PJLA.··Additionally I was trained by
·2· · · ··Susan Audino.
·3· · · · · · · · ··Are you asking me if she is trained as an
·4· · · ··expert in ISO accreditation?
·5· ·Q· ··Well, I guess, yeah, that's part of what I'm
·6· · · ··asking, yeah.··So yeah, please answer that
·7· · · ··question.
·8· ·A· ··Yes, I do believe she's an expert in ISO
·9· · · ··accreditation.
10· ·Q· ··Okay.··Well, I think you testified you didn't think
11· · · ··she was an expert.··What were you referring to that
12· · · ··she wasn't an expert in, because we were talking
13· · · ··about ISO requirements.
14· ·A· ··Well, expert is a very broad term, sir.··I just
15· · · ··wanted to make sure that we specified that.
16· ·Q· ··Would you agree that Susan Audino is a very well
17· · · ··respected scientist in the community?
18· ·A· ··I agree that Susan is very well known in the
19· · · ··community, yes, sir.
20· ·Q· ··I didn't say well known, I said well respected.
21· ·A· ··I can't speak to that.
22· ·Q· ··And is that because Susan Audino was one of the
23· · · ··scientists that reviewed the Viridis North and
24· · · ··Viridis Laboratories AOAC certification?··Is that
25· · · ··why you're not sure you can testify to that?

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·1· ·A· ··No, sir.
·2· ·Q· ··Fair to say that the CRA relies on numerous outside
·3· · · ··experts to do its job?
·4· ·A· ··I would say that we rely on information from
·5· · · ··numerous outside sources just like any other
·6· · · ··scientific body does.
·7· ·Q· ··Okay.··Fair to say you rely on the A2LA for
·8· · · ··information?
·9· ·A· ··If it were relevant, potentially, yes.
10· ·Q· ··Okay.··Fair to say that you would reach out to the
11· · · ··AOAC for information?
12· ·A· ··If it were relevant, potentially, yes.
13· ·Q· ··Fair to say that the AOAC is a trusted organization
14· · · ··across the country?
15· ·A· ··Yes.
16· ·Q· ··And is it true that the AOAC methods are actually
17· · · ··incorporated in the administrative rules that the
18· · · ··labs must follow?
19· ·A· ··Their official methods, yes, some of them are, as
20· · · ··well as their validation requirements.
21· ·Q· ··For instance, isn't it true that the CRA required
22· · · ··labs to switch aspergillus testing platforms
23· · · ··because it wanted the labs to use an AOAC-approved
24· · · ··method?··Just --
25· ·A· ··What we wanted -- I apologize.

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·1· ·Q· ··No, that was my fault.··I delayed on that.
·2· · · · · · · · ··Just at some point?
·3· ·A· ··The reason that we asked laboratories to switch to
·4· · · ··at that time an AOAC-approved method was because
·5· · · ··laboratories were using methods that were not fully
·6· · · ··validated.
·7· · · · · · · · ··And so yes, at that point in time the
·8· · · ··AOAC had worked with various vendors and groups in
·9· · · ··order to provide validated methods in order to
10· · · ··ensure that the laboratories had methods that they
11· · · ··could use that would provide accurate and
12· · · ··consistent results.
13· ·Q· ··So I'm going to read you a question and answer from
14· · · ··Allyson Chirio's deposition.··I just want to find
15· · · ··out if you think this is an accurate statement.
16· · · · · · · · ··She was asked "If a method is AOAC
17· · · ··approved, it's a reliable, tried and true method;
18· · · ··is that right?"
19· · · · · · · · ··And her answer was "If performed
20· · · ··correctly and according to the specific
21· · · ··specifications, yes."
22· · · · · · · · ··Would you agree with that?
23· ·A· ··I think it depends on what method you're talking
24· · · ··about, necessarily, and what the applicability of
25· · · ··that method is.

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·1· · · · · · · · ··So the AOAC actually has several tiers of
·2· · · ··methods that they, essentially, verify or certify.
·3· · · ··So there are the official methods of analysis,
·4· · · ··which are the gold standard, there are proficiency
·5· · · ··tested methods which are a rung just below that,
·6· · · ··and there are R-squared methods which are
·7· · · ··specifically related to instrument performance, and
·8· · · ··those are very technical methods.
·9· ·Q· ··The CRA's allegation in these superseding
10· · · ··complaints that we're here for today, at least in
11· · · ··part, that the two Viridis laboratories didn't
12· · · ··comply with Administrative Rule 420.305(2);
13· · · ··correct?
14· ·A· ··I believe that is correct.
15· ·Q· ··Okay.··And I know this is a little lengthy, but I'm
16· · · ··going to read from the rule, and you tell me if
17· · · ··this is accurate.
18· · · · · · · · ··"A laboratory shall use analytical
19· · · ··testing methodologies for the required safety tests
20· · · ··in subrule 3 of this rule that are based upon
21· · · ··published peer-reviewed methods, have been
22· · · ··validated for cannabis testing by an independent
23· · · ··third party, and have been internally verified by
24· · · ··the licensed laboratory in accordance with Appendix
25· · · ··J or K of Official Methods of Analysis authored by

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·1· · · ··the Association of Official Analytical
·2· · · ··Collaboration, AOAC International --"
·3· · · · · · · · ··Did I read that correctly, the first part
·4· · · ··of the rule?
·5· ·A· ··I believe so, sir, without looking at it.··But yes,
·6· · · ··I trust you to read that correctly.
·7· ·Q· ··Okay.··And then it goes on to say "-- with guidance
·8· · · ··from published cannabis standard method performance
·9· · · ··where available.··In the absence of published,
10· · · ··peer-reviewed, validated cannabis methods, method
11· · · ··validation requirements of Appendix J or K of the
12· · · ··Official Methods of Analysis authored by the
13· · · ··Association of Analytical Collaboration, AOAC
14· · · ··International, must be met in full with guidance
15· · · ··from published cannabis standard method performance
16· · · ··requirements where available.··The Agency may
17· · · ··monitor a laboratory analyst testing methodologies
18· · · ··on an ongoing basis."
19· · · · · · · · ··Did I read that correctly?
20· ·A· ··I'm so sorry, Mr. Russell.··Would you read just the
21· · · ··beginning of that second portion for me again,
22· · · ··please?
23· ·Q· ··Sure.··Sure.··"-- with the guidance from published
24· · · ··cannabis standard method performance requirements
25· · · ··where available."··That was the last part of the

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·1· · · ··first, I think.··And then it says "In the absence
·2· · · ··of published, peer-reviewed, validated cannabis
·3· · · ··methods, method validation requirements of
·4· · · ··Appendix J or K of Official Methods of Analysis
·5· · · ··authored by the Association of Official Analytical
·6· · · ··Collaboration."
·7· ·A· ··Thank you, sir.··Yes, that was perfect.
·8· ·Q· ··So I want to get into your understanding of this
·9· · · ··rule a little bit.
10· ·A· ··Sure.
11· ·Q· ··So would it be fair to say that there's two parts
12· · · ··for a laboratory that -- for a method that they can
13· · · ··use?··I believe the first part is what I first read
14· · · ··from the rule was if they're using a method that's
15· · · ··published, period-reviewed methods that's been
16· · · ··validated for cannabis testing by an independent
17· · · ··third party and have been internally verified by
18· · · ··the licensed laboratory according to Appendix J or
19· · · ··K.··Is that right?
20· ·A· ··Yes, sir.··Yep.
21· ·Q· ··Okay.··Is that correct, that would be one way?
22· ·A· ··Yes, sir, that is one pathway.
23· ·Q· ··Okay.··And I believe Noah Rosenzweig testified that
24· · · ··if a method is peer reviewed and published then he
25· · · ··doesn't have the -- and I may not say this exactly

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·1· · · ··right, but my understanding from his testimony was
·2· · · ··if it's peer reviewed and published and he doesn't
·3· · · ··get to make a determination on it that as long as
·4· · · ··they're following that method as peer reviewed and
·5· · · ··published then that's an appropriate method.
·6· · · · · · · · ··Will you agree with that?
·7· ·A· ··We would agree with that.··Of course, I do want to
·8· · · ··add that we would require, you know, still our
·9· · · ··basic requirements, SOPs, follow the method,
10· · · ··perform the verification as is requested by the
11· · · ··rule.
12· ·Q· ··Right.··But, I mean, that would be part of what the
13· · · ··AOAC's peer-published review would include;
14· · · ··correct?··That would be an SOP would be a
15· · · ··validation.··That's -- that's part of what that is
16· · · ··talking about; correct?
17· ·A· ··In part.··I just want to clarify though.··Sort of
18· · · ··like I said yesterday, when we want a laboratory to
19· · · ··do a verification we want them to show us that what
20· · · ··they're doing in their laboratory space with their
21· · · ··analysts, with their folks, is the same thing, and
22· · · ··it's going to produce the same results that we
23· · · ··would expect from that independent third party that
24· · · ··published and validated that method in the first
25· · · ··place.

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·1· ·Q· ··And so the way I'm understanding it, the first part
·2· · · ··of the rule is for a method that the AOAC has
·3· · · ··approved that's been peer reviewed and published;
·4· · · ··correct?
·5· ·A· ··Yes, sir.
·6· ·Q· ··Okay.··And the second part of the rule would be in
·7· · · ··the instance that there is no -- there's no
·8· · · ··peer-reviewed method and that the laboratories have
·9· · · ··to do their own research to make a determination or
10· · · ··maybe create their own validation?··Is that right?
11· · · · · · · · ··MR. RUSSELL:··Oh, no.··Are we frozen?
12· · · · · · · · ··MR. SCHUMACHER:··We're not frozen, I
13· · · ··think she froze.
14· · · · · · · · ··MR. RUSSELL:··Risa just moved so . . .
15· · · · · · · · ··JUDGE GOLDSTEIN:··She's frozen.··We lost
16· · · ··her.
17· · · · · · · · ··MR. RUSSELL:··Not us this time.
18· · · · · · · · ··JUDGE GOLDSTEIN:··I think we lost her.
19· · · ··First she froze and then she vanished.
20· · · · · · · · ··MR. RUSSELL:··Yeah.··These are the joys
21· · · ··of the Zoom world.
22· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah, I know.··Not so
23· · · ··joyful.
24· · · · · · · · ··MR. RUSSELL:··Yeah.··Judge, do you want
25· · · ··to take a break?··I mean, we've been going for a

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·1· · · ··little bit anyway.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah, about an hour
·3· · · ··almost.··All right, we'll break -- oh, she's coming
·4· · · ··right back now.··We'll still break.
·5· · · · · · · · ··MS. HUYSER:··I got booted off too.
·6· · · · · · · · ··THE WITNESS:··I'm so sorry.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··That's okay.··We're
·8· · · ··going to break now.··You weren't gone that long.
·9· · · ··We're going to break now anyway.··So why don't we
10· · · ··break till -- 15 minutes or so?
11· · · · · · · · ··MR. RUSSELL:··Could we go to 10:15, Your
12· · · ··Honor?
13· · · · · · · · ··JUDGE GOLDSTEIN:··10:15?··Okay.
14· · · · · · · · ··MR. RUSSELL:··Yes.
15· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··10:15.
16· · · ··We're off the record at 9:56 AM.··Thanks, everyone.
17· · · · · · · · ··THE WITNESS:··Thank you, Your Honor.
20· · · · · · · · ··(Break taken at 9:56 AM)
22· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··We're back
23· · · ··on the record in the matter of Viridis
24· · · ··Laboratories, LLC, and Viridis North versus
25· · · ··Cannabis Regulatory Agency, consolidated Docket

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·1· · · ··Numbers 21-029794, et al.
·2· · · · · · · · ··All right, Mr. Russell, you may continue.
·4· ·Q· ··(MR. RUSSELL) Ms. Patterson, you recall yesterday
·5· · · ··from your testimony you kind of testified to the
·6· · · ··timeline of approvals for the two Viridis
·7· · · ··laboratories and their potency method.··Do you
·8· · · ··recall that testimony?
·9· ·A· ··Yes, sir.
10· ·Q· ··Okay.··I want to show you what's been marked as
11· · · ··Exhibit 85-C1.··Lorri Rosier, who's a paralegal in
12· · · ··my office, is going to help with the exhibits.··I'm
13· · · ··not as tech savvy as Sarah was.··So if you hear me
14· · · ··talk, ask Lorri to do something, she's helping with
15· · · ··this, with these.
16· · · · · · · · ··So anyway I want to scroll through this
17· · · ··document and see if you recognize it.··If you need
18· · · ··to stop at any point as she scrolls down let me
19· · · ··know, but I believe on the last page of 48 there's
20· · · ··a signature and dates and --
21· · · · · · · · ··MR. RUSSELL:··Can you scroll down for a
22· · · ··minute?
23· ·Q· ··(MR. RUSSELL) Ms. Patterson, I believe you
24· · · ··testified yesterday that the last SOP and
25· · · ··validation or the last SOP that the CRA has on

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·1· · · ··record that was approved was in May of 2020.··Is
·2· · · ··that correct?
·3· ·A· ··The last update to the potency SOP that we have on
·4· · · ··record is May of 2020, yes, sir.
·5· ·Q· ··Okay.··And so would you agree with me that there
·6· · · ··was a previous -- there was a potency method that
·7· · · ··was approved in January 2020?
·8· ·A· ··Yes, sir.
·9· ·Q· ··Okay.··And looking at this document which has been
10· · · ··proposed as Exhibit 85-C1 are you able to tell me
11· · · ··if that was the method and validation that was
12· · · ··approved?
13· ·A· ··I would have to go back up and look particularly at
14· · · ··the homogenization portion in order to provide any
15· · · ··information on that, sir.
16· ·Q· ··Sure.··So would you point us, I guess, to
17· · · ··specifically where you need to be?
18· ·A· ··Sure.··If you could just scroll down very slowly
19· · · ··for me I can point this out for you as we get to
20· · · ··it.
21· · · · · · · · ··Keep scrolling, please.··Continue
22· · · ··scrolling if you would.
23· · · · · · · · ··Oh.··Would you stop?··Oh.··Go back up, I
24· · · ··saw the highlighted portion, if you wouldn't mind.
25· · · ··I apologize.

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·1· · · · · · · · ··There we go.··That's exactly what I --
·2· ·Q· ··We can make it bigger.
·3· ·A· ··-- need to see.
·4· ·Q· ··We can make it bigger for you too.
·5· ·A· ··Thank you, sir.
·6· · · · · · · · ··Yes, sir, that appears to be very similar
·7· · · ··to the May of 2020 method.··I would have to compare
·8· · · ··the two directly to ensure that they were exactly
·9· · · ··the same, but yes, this appears to be the method
10· · · ··referring to the homogenization.
11· ·Q· ··But this was actually approved in January 2020; is
12· · · ··that correct?
13· ·A· ··Yes, sir.··Very minor modifications were made in
14· · · ··May of 2020.··I believe -- I want to say it
15· · · ··included the addition of vitamin E acetate on that
16· · · ··Method Approval Report as well.··But yes, very
17· · · ··minor additions in the May of 2020 version.
18· ·Q· ··But would you agree that this is -- first of all,
19· · · ··before we get to that, because we will be talking
20· · · ··about that a little bit, but I just want to confirm
21· · · ··that this -- there's no dispute that there was an
22· · · ··SOP and the validation was approved in January 2020
23· · · ··and this Exhibit 85-C1 is that -- is that document.
24· ·A· ··I believe that there was one approved in January of
25· · · ··2020, as you said, yes, sir, and this does appear

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·1· · · ··to be the same document, yes, sir.
·2· · · · · · · · ··MR. RUSSELL:··Okay, Your Honor, I would
·3· · · ··move to admit Exhibit 85-C1 into evidence.
·4· · · · · · · · ··MS. HUYSER:··No objection.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Petitioner's Exhibit
·6· · · ··85?
·7· · · · · · · · ··MR. RUSSELL:··85-C1.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Let me find
·9· · · ··that here.
10· · · · · · · · ··Well, I will admit it at this point,
11· · · ··Viridis Exhibit 85-C1.··I may need to change that
12· · · ··after I find them.
13· · · · · · · · ··I'm going to keep it simple.··At this
14· · · ··point I will indicate that Viridis Exhibit 85-C1 is
18· ·Q· ··(MR. RUSSELL) Ms. Patterson, just a couple things
19· · · ··on this SOP.
20· · · · · · · · ··And this would be considered the sample
21· · · ··prep portion of this; is that correct?
22· ·A· ··Yes, sir, in particular the homogenization step,
23· · · ··and then the actual preparation steps after that.
24· ·Q· ··Okay.··And so there's just a couple things I want
25· · · ··to ask you about.··The first sentence there talks

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·1· · · ··about the analysis requires, and I believe that's
·2· · · ··an approximate sign, 1 gram of homogenized cannabis
·3· · · ··plant material.··Is that correct?
·4· ·A· ··Yes.
·5· ·Q· ··Okay.··And you testified yesterday, and we'll get
·6· · · ··into it a little bit, about there was some emails
·7· · · ··with Dr. Glinn in November 2020 related to this
·8· · · ··issue of the approximate; is that right?
10· ·Q· ··Okay.··And the only other thing I want to ask you
11· · · ··about on this is you would agree that this SOP and
12· · · ··validation states that alumina balls will be used;
14· ·A· ··Yes, sir, this states that alumina balls will be
15· · · ··used, that is correct.
16· ·Q· ··Okay.··And it's my understanding then if that's
17· · · ··what the SOP and validation was approved for then
18· · · ··that's what Viridis North and Viridis Laboratories
19· · · ··will be required to use will be alumina balls?
20· ·A· ··That is correct, sir, yes, approximately 1 gram
21· · · ··homogenized material for 10 millimeter alumina
22· · · ··balls.
23· · · · · · · · ··MR. RUSSELL:··Okay.··You can take that
24· · · ··down.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, I'm having

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·1· · · ··difficulty finding 85-C1.··Did you mark this as --
·2· · · ··I have --
·3· · · · · · · · ··MR. RUSSELL:··What's the Bates number?
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Your numbered exhibits
·5· · · ··stop at 74, and then it goes 86, 87, 88.··I don't
·6· · · ··have 85-C1 in here.··I have a number of . . .
·7· · · · · · · · ··MR. RUSSELL:··There should be a separate
·8· · · ··folder, Your Honor, that says deposition exhibits.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··Well, I have Chirio dep
10· · · ··exhibits --
11· · · · · · · · ··MR. RUSSELL:··This would be Rosenzweig
12· · · ··dep exhibits.··And it's Bates number starting with
13· · · ··2103.
14· · · · · · · · ··JUDGE GOLDSTEIN:··Well, those --
15· · · ··Rosenzweig's dep exhibits go through 38.
16· · · · · · · · ··MR. RUSSELL:··So it's Exhibit 85-C1, so
17· · · ··it's the first of his dep exhibits.
18· · · · · · · · ··MR. SCHUMACHER:··Did he not get the
19· · · ··updated Bates-numbered exhibits we sent last week?
20· · · · · · · · ··JUDGE GOLDSTEIN:··Yes, I'm -- I have this
21· · · ··marked as Rosenzweig Exhibit 1 so . . .
22· · · · · · · · ··MR. RUSSELL:··Do you have it, Judge?··I
23· · · ··can resend it.··These were sent -- these were
24· · · ··resent with the Bates numbers to make it easier.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Well, that's okay.··I

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·1· · · ··can remark them as the hearing progresses.··I just
·2· · · ··want to make sure that I have the same exhibit
·3· · · ··here.··49 pages; right?
·4· · · · · · · · ··MR. RUSSELL:··Correct, Your Honor.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··So I'm just
·6· · · ··going to remark that at this point, so the record
·7· · · ··is clear, as Viridis Exhibit 85.··Okay?
·8· · · · · · · · ··MR. RUSSELL:··Yeah, that's fine, Your
·9· · · ··Honor.··But there will be multiple 85s because we
10· · · ··used each of the -- that dep exhibits as -- like
11· · · ··you'll see this one 85-C1, and then I believe there
12· · · ··are -- how many.··There's numerous from that
13· · · ··so . . .
14· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Well, obviously
15· · · ··they're all over the place, so I need to keep some
16· · · ··kind of order here.
17· · · · · · · · ··MR. RUSSELL:··Sure.··I understand.
18· · · · · · · · ··JUDGE GOLDSTEIN:··I can start at the very
19· · · ··beginning if you want.
20· · · · · · · · ··MR. RUSSELL:··I'm sorry?
21· · · · · · · · ··JUDGE GOLDSTEIN:··I can start from the
22· · · ··very beginning.··It's not hard to remark these.
23· · · · · · · · ··MR. RUSSELL:··However you want to do it,
24· · · ··Your Honor.··As long as it's admitted into evidence
25· · · ··we're fine with it.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··I can remark it as
·2· · · ··starting with numbers starting with 1 if you want,
·3· · · ··and that way I'll keep progression as they come
·4· · · ··into the record.
·5· · · · · · · · ··MR. RUSSELL:··I'm fine with that, Your
·6· · · ··Honor.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··The way you're
·8· · · ··submitted them they're all over the place.··They're
·9· · · ··under different folders.··So it just -- I think it
10· · · ··would work a lot better if I just remark them as
11· · · ··the hearing progresses.
12· · · · · · · · ··MR. RUSSELL:··That's fine, Your Honor.
13· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··All right.··So
14· · · ··this one is going -- this is going to be now, so
15· · · ··the record is clear, marked, or admitted, as
16· · · ··Viridis Exhibit Number 1.
17· · · · · · · · ··MR. RUSSELL:··Thank you, Judge.
19· · · · · · · · ··(Viridis Exhibit 1 is admitted.)
20· ·Q· ··(MR. RUSSELL) Ms. Patterson, you testified
21· · · ··yesterday about notifying the two Viridis
22· · · ··laboratories, right -- it actually may have just
23· · · ··been Viridis Laboratories in Lansing -- about
24· · · ··receiving complaints of potency levels being too
25· · · ··low.··Do you recall that testimony?

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·1· ·A· ··It wasn't related to complaints, no, sir, it was
·2· · · ··related to data that we identified in Metrc.
·3· ·Q· ··So you did not receive a complaint from a customer
·4· · · ··that the potency level was being recorded as being
·5· · · ··too low?
·6· ·A· ··No, sir, not that I can recall.
·7· ·Q· ··Do you recall an email from Allyson Chirio that was
·8· · · ··sent to Todd Welch and the other owners of Viridis
·9· · · ··related to this -- this potency issue?
10· ·A· ··Related to low potency?
11· ·Q· ··Correct.
12· ·A· ··No, sir, I do not recall that email.
13· · · · · · · · ··MR. RUSSELL:··Okay.··Are you able to put
14· · · ··that on the screen?
15· ·Q· ··(MR. RUSSELL) We're going to show you this email to
16· · · ··refresh your recollection.
18· · · · · · · · ··MR. RUSSELL:··Can you make it a little
19· · · ··bigger?
20· · · · · · · · ··THE WITNESS:··Thank you.
21· · · · · · · · ··MR. RUSSELL:··Just scroll to the top.
22· ·Q· ··(MR. RUSSELL) Okay.··So it appears the date on this
23· · · ··is May 18, 2020, and it says "from MRA."··It
24· · · ··doesn't say who.··I guess, is that your general
25· · · ··mailbox?

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·1· ·A· ··Yes, sir, the MRA-scf is our general scientific
·2· · · ··mailbox.
·3· ·Q· ··Okay.··And this is an email from Todd Welch, Greg
·4· · · ··Michaud, and Michele Glinn; is that correct?
·5· ·A· ··Yes, sir.
·6· ·Q· ··You're copied on this email?
·7· ·A· ··Yes, sir.
·8· ·Q· ··Okay.··And I believe here in the summary it says
·9· · · ··"Viridis Bay City received a complaint from the
10· · · ··licensee that potency results for their sample was
11· · · ··much lower than anticipated."
12· ·A· ··Yes, sir.··So that complaint was received by
13· · · ··Viridis Bay City, not the CRA, just to clarify.
14· ·Q· ··Okay.··And so what was the purpose of this email
15· · · ··then?
16· ·A· ··Well, sir, the purpose of this email actually
17· · · ··originated from an additional, and I'm going to say
18· · · ··conversation, I'm not sure whether it was a phone
19· · · ··conversation between Todd Welch and Dr. Chirio or
20· · · ··if there was an email conversation that took place,
21· · · ··but I do know that I would estimate or guess that
22· · · ··it was Todd Welch had contacted us and let us know
23· · · ··that they had received a complaint from this
24· · · ··licensee and that their potency results were,
25· · · ··quote/unquote, much lower than anticipated.

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·1· · · · · · · · ··And I believe what the lab had discussed
·2· · · ··is that they identified differences in the sample
·3· · · ··preparation techniques used by the different prep
·4· · · ··techs.··He noted that they had demonstrated to show
·5· · · ··13 to 17 percent potency by one and 15 to 20
·6· · · ··percent by the other.··Viridis noted that if there
·7· · · ··was an error in the SOP it would be related to a
·8· · · ··training issue.··They had not identified all
·9· · · ··samples affected and that they requested our
10· · · ··assistance in subcontracting those samples to
11· · · ··Viridis Lansing until those issues had been
12· · · ··corrected and addressed.
13· · · · · · · · ··So this was essentially just a
14· · · ··notification to me of the activities that were
15· · · ··occurring at Viridis Bay City, their attempt to
16· · · ··remediate this issue, and specifically to follow up
17· · · ··on some training issues related to their sample
18· · · ··prep technicians.
19· ·Q· ··And as part of this email, and I think if you look
20· · · ··at the bottom, although it's a general mailbox, it
21· · · ··was from Allyson Chirio?
22· ·A· ··Yep, that's her signature.
23· ·Q· ··Is it?
24· ·A· ··Yes, sir.
25· ·Q· ··All right.··And so the last -- well, I guess the

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·1· · · ··second-to-last paragraph before the last line there
·2· · · ··states "Per Claire the sample preparation
·3· · · ··procedures are the same at both locations.··Before
·4· · · ··the MRA will approve the transfer of subcontracted
·5· · · ··samples Viridis Lansing will need to provide proof
·6· · · ··that their sample preparation is generating
·7· · · ··accurate results."
·8· · · · · · · · ··Did I read that correctly?
·9· ·A· ··Yes, sir.
10· ·Q· ··Okay.··And the "per Claire," that I'm assuming
11· · · ··refers to you, Ms. Patterson?
12· ·A· ··Yes, sir, it does.
13· ·Q· ··Okay.··And so my understanding, isn't it true that
14· · · ··at this point the CRA is -- is indicating to
15· · · ··Viridis Laboratories that they need to take a
16· · · ··review of their sample preparation for the potency
17· · · ··testing?
18· ·A· ··No, sir, this is actually me suggesting that they
19· · · ··need to particularly look at how their samples are
20· · · ··preparing -- or how their technicians, excuse me,
21· · · ··are preparing those samples as it relates to their
22· · · ··standard operating procedure.··Because you'll note
23· · · ··that I believe Todd Welch had stated that they
24· · · ··noted that there was a difference in how those
25· · · ··techs were performing that.··And you'll see here

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·1· · · ··the proof will be the updated IDOCs which are the
·2· · · ··initial demonstrations of capability.··And that
·3· · · ··essentially shows us that the technicians are all
·4· · · ··performing this method as it is written in the same
·5· · · ··way from technician to technician.··So this is
·6· · · ··really more of a training issue.
·7· · · · · · · · ··MR. RUSSELL:··You can take that down.
·8· ·Q· ··(MR. RUSSELL) And so as a result of that Viridis
·9· · · ··was required to file a Corrective Action Report; is
11· ·A· ··I believe that was included in that paragraph that
12· · · ··was requested by Dr. Chirio, yes.··I believe that
13· · · ··was part of it.
14· ·Q· ··And do you recall receiving that Corrective Action
15· · · ··Report?
16· ·A· ··From recollection and memory, sir, I do not.
17· · · · · · · · ··MR. RUSSELL:··Okay.··Can you pull that
18· · · ··up?··No, that's not it.
19· · · · · · · · ··MS. HUYSER:··Hey, Dave, were you
20· · · ··admitting the exhibit that you just showed, or was
21· · · ··it just to refresh her memory?
22· · · · · · · · ··MR. RUSSELL:··I was just refreshing
23· · · ··recollection.··It's not part of our exhibit list.
24· · · ··I have no issue admitting it, but if you have an
25· · · ··objection I understand because we didn't include

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·1· · · ··it.
·2· · · · · · · · ··MS. HUYSER:··I don't have an objection to
·3· · · ··it.
·4· · · · · · · · ··MR. RUSSELL:··If that's the case I would
·5· · · ··move to have that admitted as, I guess we would be
·6· · · ··on Exhibit 2 now?
·7· · · · · · · · ··JUDGE GOLDSTEIN:··I'm sorry, Counsel,
·8· · · ··which exhibit was that again?
·9· · · · · · · · ··MR. RUSSELL:··That was the email that was
10· · · ··just shown, the 5/18/2020 email from Allyson Chirio
11· · · ··to Todd Welch.
12· · · · · · · · ··JUDGE GOLDSTEIN:··And what exhibit was
13· · · ··that in your --
14· · · · · · · · ··MR. RUSSELL:··It was not an exhibit,
15· · · ··which I was just stating to Ms. Huyser that I was
16· · · ··using it to refresh Ms. Patterson's recollection.
17· · · ··But I said if she didn't have an objection to
18· · · ··entering it because it wasn't on our witness list
19· · · ··then we would do so.
20· · · · · · · · ··JUDGE GOLDSTEIN:··Does the Tribunal even
21· · · ··have that exhibit?
22· · · · · · · · ··MR. RUSSELL:··No, Your Honor.
23· · · · · · · · ··MR. SCHUMACHER:··I can email it.
24· · · · · · · · ··JUDGE GOLDSTEIN:··So you will submit it
25· · · ··after the hearing?

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·1· · · · · · · · ··MR. RUSSELL:··Yes.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··That email
·3· · · ··then is marked as Viridis Exhibit 2 and is
·5· · · · · · · · ··(Viridis Exhibit 2 is admitted.)
·6· · · · · · · · ··MR. RUSSELL:··We'll just move on.
·7· ·Q· ··(MR. RUSSELL) So were you aware that two days later
·8· · · ··after this -- this email and a Corrective Action
·9· · · ··Report was -- was submitted that Viridis provided
10· · · ··an updated SOP?
11· ·A· ··I believe so.··I believe they provided an SOP that
12· · · ··would provide clarification to their technicians
13· · · ··for training purposes to ensure that they all
14· · · ··understood what the term homogenization meant.
15· · · · · · · · ··I believe in the SOP that you showed me
16· · · ··from January of 2020 that it just said
17· · · ··homogenization, whereas the updated method that
18· · · ··they provided us I think in May of 2020 really
19· · · ··further defined what homogenization was for the
20· · · ··purposes of their technicians and being able to
21· · · ··follow that procedure on a day-to-day basis.
22· ·Q· ··So you had indicated that you didn't recall,
23· · · ··necessarily, the Corrective Action Report.··I just
24· · · ··want to show you that real quick to refresh your
25· · · ··recollection.··I don't think it's necessary to make

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·1· · · ··that an exhibit, but I want to ask you if you've
·2· · · ··seen this before.
·3· ·A· ··Thank you for showing me this, sir.··I will admit
·4· · · ··to you I don't necessarily recall seeing it.··It's
·5· · · ··been three years, and that is a long time.··But I
·6· · · ··believe if you are showing me this that I have
·7· · · ··likely seen it, yes.
·8· ·Q· ··Okay.··Thank you.
·9· · · · · · · · ··And I think you just testified that you
10· · · ··did -- do you recall receiving an updated SOP on
11· · · ··5/20/2020?
12· · · · · · · · ··MR. RUSSELL:··You can take it down.
13· · · · · · · · ··THE WITNESS:··Yes, sir, that is correct.
14· ·Q· ··(MR. RUSSELL) Okay.··And I believe you testified
15· · · ··earlier that this is the last approved SOP that the
16· · · ··CRA recognizes.··Is that correct?
17· ·A· ··Yes, sir, that is correct.
18· ·Q· ··Okay.··And, in fact, the 5/20/2020 SOP actually
19· · · ··made numerous changes to the sample prep in it;
20· · · ··correct?
21· ·A· ··That is not correct.··And actually didn't make
22· · · ··numerous changes, it provided one clear
23· · · ··clarification for sample technicians in order for
24· · · ··them to be able to consistently and accurately
25· · · ··perform the method and the homogenization in

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·1· · · ··particular in a way that was in alignment with how
·2· · · ··the SOP was written.
·3· ·Q· ··So --
·4· ·A· ··I would not consider -- oh.··I apologize, sir.
·5· ·Q· ··No, I want you to finish.
·6· ·A· ··I was going to say we would not consider that a
·7· · · ··substantive change because it does not change the
·8· · · ··outcome of the method but rather clarifies the term
·9· · · ··homogenization for those technicians so that they
10· · · ··can consistently perform that test in the
12· ·Q· ··So I want to be clear, because yesterday I believe
13· · · ··you testified very clearly that the November 20th
14· · · ··and December 30th, 2020, updated SOP had to -- had
15· · · ··to have a new validation, it always has to have a
16· · · ··new validation when there was a change to the
17· · · ··sample prep, which this SOP clearly makes a change
18· · · ··in the sample prep; correct?
19· ·A· ··I would --
20· ·Q· ··Now today your testimony is that it's only if
21· · · ··there's a change in the outcome.
22· ·A· ··No, sir.··What I said yesterday is that what we
23· · · ··would require a validation for is if there was a
24· · · ··substantive change.
25· · · · · · · · ··So what you're referring to between

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·1· · · ··January and May of 2020 again is not a substantive
·2· · · ··change that would change the outcome of the total
·3· · · ··test.··So what they're doing between January and
·4· · · ··May of 2020 is further clarifying the term
·5· · · ··homogenize.
·6· · · · · · · · ··The difference between that and what
·7· · · ··occurred in November slash December of 2020, and
·8· · · ··then further June of 2021, those changes are not
·9· · · ··homogeneous and actually deviate significantly from
10· · · ··the definition of the word homogeneous.
11· · · · · · · · ··Additionally, the changes that were
12· · · ··included in the November slash December and June of
13· · · ··2021 methods include a significant variation
14· · · ··related to the amount of weight of flower that is
15· · · ··added to the sample as well as the fact that the
16· · · ··grinding media, those grinding balls, are
17· · · ··specifically added to the -- the vials that are
18· · · ··used further for extraction.··Those are considered
19· · · ··substantive changes and would require validation
20· · · ··and full submission to the CRA for approval.
21· ·Q· ··So you seem to be splitting hairs here or your
22· · · ··testimony has changed from yesterday because,
23· · · ··obviously, the updated SOP was a result of the CRA
24· · · ··coming in and saying these potency results are too
25· · · ··low on May 18th, 2020.··An updated SOP is issued

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·1· · · ··that specifically changes the sample prep to ensure
·2· · · ··that the outcome is different than what it was
·3· · · ··prior.
·4· · · · · · · · ··So there would have been a change in the
·5· · · ··outcome absolutely from the -- previous to the May
·6· · · ··18th, 2020, to after the May 18th, 2020, but yet
·7· · · ··your testimony today when it seems to fit your
·8· · · ··purposes is there wouldn't be a validation
·9· · · ··required.··But it doesn't -- it doesn't -- it's
10· · · ··not -- it's not consistent with what you testified
11· · · ··to yesterday.
12· ·A· ··Sir, it's consistent with what I testified to
13· · · ··yesterday and I apologize if that feels like
14· · · ··splitting hairs.··However, the nuance is very
15· · · ··important here.··As I said before this is simply
16· · · ··clarifying what the term homogenization means for
17· · · ··the purposes of ensuring consistency between
18· · · ··technicians that are performing this method.
19· · · · · · · · ··Todd Welch himself admitted that
20· · · ··technicians were performing this method in a way
21· · · ··that resulted in disparate results, and that in and
22· · · ··of itself is an issue.··Because the laboratory
23· · · ··sought to actually clarify the term homogenization
24· · · ··instead of essentially relying on the technicians
25· · · ··to assume what that term meant they actually

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·1· · · ··brought more harmony to the method by giving it
·2· · · ··that clarity.
·3· · · · · · · · ··Now, that does not actually change the
·4· · · ··outcome of the results but it brings harmony
·5· · · ··between the way that the technicians are reading,
·6· · · ··interpreting, and performing the standard operating
·7· · · ··procedure.··That varies significantly from the
·8· · · ··December method and the May method -- or excuse
·9· · · ··me -- the December 2020 method and the June of 2021
10· · · ··method because those methods actually added
11· · · ··significant changes to the way the sample was
12· · · ··prepped and then what happened to those grinding
13· · · ··media after the sample was homogenized.··Those
14· · · ··things would result in an actual change or
15· · · ··potentially a hypothesized change to the outcome of
16· · · ··those standard operating procedures as they are
17· · · ··performed.
18· · · · · · · · ··So, again, I apologize that it seems like
19· · · ··splitting hairs, but in this case splitting hairs
20· · · ··is incredibly important to understand how these
21· · · ··methods function in practice.
22· ·Q· ··Your testimony was that the change in weight would
23· · · ··change the outcome; correct?
24· ·A· ··My testimony was not that the change in weight
25· · · ··would change the outcome necessarily but my

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·1· · · ··testimony was rather that they used the term
·2· · · ··approximately 1 gram.··And in their initial
·3· · · ··verification Michele Glinn herself noted that by
·4· · · ··decreasing the amount of sample weight in any
·5· · · ··sample that is prepared we are actually increasing
·6· · · ··the relative standard deviation and the outcome of
·7· · · ··those results meaning that those results are going
·8· · · ··to essentially be spread apart over the true value.
·9· · · · · · · · ··Now, she herself admitted that we want to
10· · · ··reduce standard deviation and bring it closer to
11· · · ··its true center.··So what I find interesting was
12· · · ··the fact that the verification noted that it should
13· · · ··be done at approximately 1 gram, reasonably so, and
14· · · ··that it should not differ significantly from that,
15· · · ··and yet in both the December 2020 method and the
16· · · ··June of 2020 -- or 2021 method, excuse me -- we saw
17· · · ··that that sample weight was decreasing
18· · · ··significantly.
19· · · · · · · · ··Additionally, we saw the addition of the
20· · · ··scraped trichome material off of the grinding media
21· · · ··which, of course, is challenging to rehomogenize
22· · · ··into the homogeneous plant material.
23· · · · · · · · ··And then we ended up seeing in June of
24· · · ··2021 the addition of those grinding media directly
25· · · ··to the dilution vials -- or excuse me -- extraction

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·1· · · ··vials that are used in the method.
·2· · · · · · · · ··So those methods are significantly
·3· · · ··different.
·4· ·Q· ··So we can agree then that when an SOP is submitted
·5· · · ··to the CRA via email there are times when a
·6· · · ··validation is not required; correct?
·7· ·A· ··Yes, sir.··And I did state that yesterday.··That
·8· · · ··would depend on whether or not there were
·9· · · ··substantive changes that could change the outcome
10· · · ··of the results.
11· ·Q· ··Right.··Substantive changes that would change the
12· · · ··outcome of the results.
13· ·A· ··Yes, sir.
14· ·Q· ··Correct?··That's your testimony?
15· ·A· ··Yes, sir.
16· ·Q· ··And when you received this updated SOP that you
17· · · ··approved without a validation there was never any
18· · · ··method approval form that was sent; correct?
19· ·A· ··No, because this is not considered a substantive
20· · · ··change.··This is, again, to bring harmony between
21· · · ··sample technicians.
22· ·Q· ··I see.··And I assume that you notified Viridis of
23· · · ··that fact through an email or some type of
24· · · ··correspondence?
25· ·A· ··Yes, sir, we would.

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·1· ·Q· ··Okay.··And you have that email somewhere?
·2· ·A· ··An email that would be issued for a hypothetical
·3· · · ··method approval?
·4· · · · · · · · ··I apologize.··Maybe I misunderstood.
·5· ·Q· ··Well, I'm just assuming you would have -- you would
·6· · · ··have let the licensee know that there's -- there's
·7· · · ··no change to the outcome of this method so we're
·8· · · ··not going to require a validation.··Right?
·9· ·A· ··Well, we requested this, again, as part of the
10· · · ··corrective action and preventative action.··We
11· · · ··specifically requested that the licensee provide
12· · · ··this clarification in order to ensure that their
13· · · ··technicians were performing this SOP in the same
14· · · ··way consistently between one another all of the
15· · · ··time.
16· · · · · · · · ··So no, I do not believe that would be
17· · · ··necessary.··We only issue those forms in the event
18· · · ··that a licensee submits an SOP with substantive
19· · · ··changes.
20· ·Q· ··Okay.··And so exactly the same as in November when
21· · · ··you again requested an updated SOP; correct?
22· ·A· ··We requested an updated SOP at that time not due to
23· · · ··a corrective action and preventative action but,
24· · · ··rather, to determine what the laboratory was doing
25· · · ··in practice in that space because we had noticed a

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·1· · · ··significant increase in the reporting of high
·2· · · ··potency flower values.
·3· ·Q· ··Right.··So in the May issue you had noted a
·4· · · ··significant reporting of low potency.··You reach
·5· · · ··out, you say to Viridis Laboratories, we're going
·6· · · ··to need an updated SOP.··They provide it to you and
·7· · · ··it's approved.
·8· · · · · · · · ··There's not a method approval form?
·9· · · ··There's nothing that's sent; correct?
10· ·A· ··Well, yes, that is correct.··There are some
11· · · ··distinctions between the two events, but yes.
12· ·Q· ··Well, I understand you're testifying to all these
13· · · ··distinctions that I'm sure are somewhere in the
14· · · ··rules that you're going to tell me about, but the
15· · · ··same process then occurs in May of 2020 where you
16· · · ··said potency's too low, I need an updated SOP.
17· · · ··They provide it to you by email.··Okay, that's
18· · · ··fine.··Nothing's sent.
19· · · · · · · · ··You had testified yesterday, yes, we
20· · · ··always send Method Approval Reports.··That's our
21· · · ··procedure.··When I started at the CRA that's what I
22· · · ··instituted.··But yet here you testify there's no
23· · · ··Method Approval Report sent.
24· · · · · · · · ··So what Viridis knows at this point is
25· · · ··that they approved the January 2020 with a

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·1· · · ··validation.··May 2020 they submit an updated SOP
·2· · · ··without a validation because it wasn't required.
·3· · · ··And it was -- it was requested by you.
·4· · · ··Fast-forward to November 2020.··Again you request
·5· · · ··an updated SOP.··They provide that to you.··There's
·6· · · ··no response; correct?
·7· ·A· ··That is correct.··But again I would like to remind
·8· · · ··you that that's not precisely what I testified to
·9· · · ··yesterday.··And additionally there are some very
10· · · ··critical distinctions between those two incidences
11· · · ··that I think should be clarified.
12· ·Q· ··There is no procedure that the two laboratories or
13· · · ··any of the laboratories receive that says this is
14· · · ··when we're going to send out a Method Approval
15· · · ··Report.··This is when you have to provide a
16· · · ··validation.··This is when you need a verification.
17· · · ··Correct?
18· ·A· ··Well, no, we would not provide Agency procedures to
19· · · ··our licensees typically.
20· ·Q· ··Right.··Why would you want them to know what
21· · · ··they're supposed to be doing as far as following
22· · · ··the rules; right?
23· ·A· ··Oh, no.··Well, we would ask that they refer to the
24· · · ··statutes and the applicable rules.
25· · · · · · · · ··Additionally, we do communicate with our

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·1· · · ··licensees that we require a method validation SOP,
·2· · · ··the associated data, etc., whenever a substantive
·3· · · ··change is made to a standard operating procedure.
·4· ·Q· ··And where can they go to look to find that?··Where
·5· · · ··would they see that at?
·6· ·A· ··Currently we actually have provided them a method
·7· · · ··validation guidance document.··But additionally
·8· · · ··that's something that a laboratory would typically
·9· · · ··know.··But certainly I would be happy to
10· · · ··communicate that information with any licensee that
11· · · ··was seeking to understand when it would be
12· · · ··appropriate for them to submit a data package
13· · · ··versus a simple SOP update to ensure consistency
14· · · ··and harmony between their technicians in the
15· · · ··laboratory space.
16· ·Q· ··So is this one of these inherent things that you
17· · · ··talked about yesterday that everyone should just
18· · · ··know?
19· ·A· ··No --
20· ·Q· ··You testified --
21· ·A· ··-- not necessarily.
22· ·Q· ··Let me finish.
23· · · · · · · · ··You testified yesterday as it related to
24· · · ··keeping logbooks, well, it's inherent.··Okay.··So
25· · · ··is this an inherent thing as well?··I'm just

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·1· · · ··wondering, is the CRA enforcing inherent rules that
·2· · · ··aren't written somewhere?
·3· ·A· ··Sir, I would classify those as two very, very
·4· · · ··separate issues.
·5· · · · · · · · ··However, what I was going to say is that
·6· · · ··if a laboratory, in particular Viridis, who I have
·7· · · ··had numerous conversations with, had questions
·8· · · ··about whether or not a validation or data or any of
·9· · · ··that information is required to submit to the
10· · · ··Agency they would ask me that question.··Viridis
11· · · ··has always been very good about asking a lot of
12· · · ··questions, particularly when it assists them in
13· · · ··receiving method approvals and understanding what
14· · · ··is approved for them to use in the laboratory
15· · · ··space.
16· ·Q· ··You just testified yesterday that you didn't have
17· · · ··conversations with Viridis because you wanted to
18· · · ··make sure there was a record.··That's what you
19· · · ··testified to.··So there wasn't conversations back
20· · · ··and forth there were emails so that any
21· · · ··conversation that you're talking about or any
22· · · ··questions you're talking about there would be a
23· · · ··record of them.··And we'll get into the November
24· · · ··emails here in a minute.··But you yourself
25· · · ··testified there weren't conversations going back

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·1· · · ··and forth because, in fact, the relationship was so
·2· · · ··bad at that point because the CRA was doing
·3· · · ··everything they could to investigate everything
·4· · · ··that Viridis was doing that their relationship was
·5· · · ··completely adversarial; correct?
·6· ·A· ··I think that that's a bit of a mischaracterization
·7· · · ··of the timeline.··Currently you and I are
·8· · · ··discussing the timeline as it relates to May of
·9· · · ··2020 when at that point in time I would say that
10· · · ··the relationship was much less adversarial and some
11· · · ··conversations actually did occur via telephone.
12· · · · · · · · ··I apologize if you think that
13· · · ··conversations are not occurring via email; however,
14· · · ··I will admit that yesterday during my testimony
15· · · ··that I did say that our communications via email
16· · · ··were the standard practice around the end of 2020
17· · · ··to ensure that, obviously, there was a written
18· · · ··record of these items.··But as it relates to the
19· · · ··May of 2020 method, these conversations very well
20· · · ··could have happened over the telephone or over a
21· · · ··video conference or something of that nature.
22· ·Q· ··But there was never a conversation between you
23· · · ··personally and anyone from Viridis North or Viridis
24· · · ··Laboratories that a validation wasn't required for
25· · · ··this SOP; correct?

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·1· ·A· ··I can't speak to that.··I can't recall if there was
·2· · · ··or was not.··If there wasn't a record, I'm unable
·3· · · ··to answer that question, sir.
·4· ·Q· ··Okay.··As you sit here today you have no
·5· · · ··recollection of a phone call that you had with
·6· · · ··anyone from Viridis North or anyone from Viridis
·7· · · ··Laboratories telling them that they weren't
·8· · · ··required to provide a validation as part of this
·9· · · ··May 2020 SOP?
10· ·A· ··I can't speak to that.··I have told laboratories,
11· · · ··various laboratories, various licensees, numerous
12· · · ··times what would or would not require a validation
13· · · ··as it relates to a substantive change in a method.
14· ·Q· ··Well, what we've established, though, is the last
15· · · ··SOP that the CRA recognizes is the May 2020 SOP --
16· ·A· ··Uh-huh.
17· ·Q· ··-- that didn't come with a validation; correct?
19· ·Q· ··Okay.··And we've established that there are certain
20· · · ··instances when a validation is not required;
21· · · ··correct?
22· ·A· ··Yes, as long as no substantive changes are made,
23· · · ··that is correct.
24· ·Q· ··Okay.··And we've established that there was nowhere
25· · · ··that the laboratories can go to see that procedure

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·1· · · ··from the CRA or the MRA at that time; correct?
·2· ·A· ··Yes.
·3· ·Q· ··That's inherent -- correct?
·4· ·A· ··Yes, sir, that is correct.
·5· ·Q· ··Okay.
·6· ·A· ··That would be knowledge that they could seek from
·7· · · ··us or they would know that, quite frankly, as
·8· · · ··scientists who were familiar with performing
·9· · · ··research methods.
10· ·Q· ··Oh, I see.··So as scientists they should recognize
11· · · ··what the CRA's procedures are, is that -- is that
12· · · ··your testimony?
13· ·A· ··No, sir, what I'm saying is that they should
14· · · ··understand what a substantive change to a standard
15· · · ··operating procedure would look like.
16· ·Q· ··Well, you're familiar with technical guidance;
17· · · ··correct?
18· ·A· ··What type of technical guidance, sir?
19· ·Q· ··The CRA issues technical guidance to its licensees;
20· · · ··correct?
21· ·A· ··Yes, I -- I -- you're talking about the Safety
22· · · ··Compliance Facility Testing Guide?··Is that
23· · · ··correct?
24· ·Q· ··Yes.··Correct.
25· ·A· ··Okay.··Yes.

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·1· ·Q· ··Okay.··And that guidance changes regularly;
·2· · · ··correct?
·3· ·A· ··No, that is not correct.··It changes on a set
·4· · · ··schedule, and it relates to specifically the
·5· · · ··promulgation of the administrative rules.
·6· ·Q· ··Well, isn't it true that the February 2021
·7· · · ··technical guidance changed specifically to discuss
·8· · · ··when a validation was needed with a new SOP?
·9· ·A· ··I can't speak to that without looking at the
10· · · ··various iterations of it, sir, but it is certainly
11· · · ··likely.
12· ·Q· ··Well, if it's inherent, why would you need to put
13· · · ··that in the February 2021 technical guidance?
14· ·A· ··Because licensees such as Viridis are inherently
15· · · ··confused, it would seem, and it would behoove us to
16· · · ··provide that information to them so that they are
17· · · ··no longer confused when facing situations like
18· · · ··this.
19· ·Q· ··So the laboratories were confused.··So it wasn't an
20· · · ··inherent thing that they understood.
21· ·A· ··I believe that it should be an inherent thing and
22· · · ··it is an inherent thing in the general scientific
23· · · ··testing space.··However, I will say in the cannabis
24· · · ··testing space, because it is so new in the realm of
25· · · ··science, there absolutely is a -- an unusual amount

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·1· · · ··of confusion, particularly on behalf of our
·2· · · ··licensees.
·3· ·Q· ··Wouldn't you agree that the CRA, if their goal
·4· · · ··truly is public health and safety, they have an
·5· · · ··obligation to its licensees to set guidelines that
·6· · · ··the licensees are able to follow?
·7· ·A· ··Yes, sir.
·8· ·Q· ··Okay.··And so when -- what you just testified to,
·9· · · ··which I heard you say is as scientists in the
10· · · ··community you should understand the validation's
11· · · ··required here, it's not required here, clearly that
12· · · ··is a gray area at the very least.··And I believe
13· · · ··there will be other experts that are going to
14· · · ··testify in this matter that are going to say that
15· · · ··in November or December a validation wasn't
16· · · ··required for what was produced and provided to the
17· · · ··CRA.
18· · · · · · · · ··So wouldn't you agree that there would be
19· · · ··a difference of opinion as to when a validation's
20· · · ··actually required?
21· ·A· ··No, because we are the regulatory body.··So I would
22· · · ··say that whatever is required would be required by
23· · · ··us, and that is based on the experience that we all
24· · · ··hold as research scientists and in academia and
25· · · ··other places.

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·1· ·Q· ··That's remarkable testimony.
·2· · · · · · · · ··So what you're saying is that you, the
·3· · · ··CRA, has this great body of knowledge that the
·4· · · ··licensees don't hold, but yet you don't have any
·5· · · ··guidance out there for them as to when a validation
·6· · · ··is required.··It's kind of like a game of gotcha;
·7· · · ··right?··Well, you didn't need a validation here but
·8· · · ··you need a validation here?
·9· ·A· ··No, sir, I don't think it's a game of gotcha.··I
10· · · ··want to clarify that I absolutely, and so do my
11· · · ··scientists, hold an open-door policy when it comes
12· · · ··to questions related to matters such as this.··We
13· · · ··frequently have licensees ask us repeatedly what it
14· · · ··is that we need from them.··We help them clarify.
15· · · · · · · · ··And as is the case with Viridis and
16· · · ··Viridis North we had frequent communications, be it
17· · · ··email or in person or via telecommunications, where
18· · · ··we expressed our expectations to Viridis, they
19· · · ··reciprocated with their understanding, and they
20· · · ··followed up accordingly.··So I believe that they've
21· · · ··demonstrated their ability to gain this
23· · · · · · · · ··Now, if we have licensees that are asking
24· · · ··those same questions over and over again, that's
25· · · ··when it becomes apparent to us that we need to

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·1· · · ··issue some additional guidance in order to better
·2· · · ··assist our licensees and provide that knowledge up
·3· · · ··front.··And I believe that's what you're indicating
·4· · · ··that we did in the February 2021 I think you said
·5· · · ··safety compliance testing guide.
·6· · · · · · · · ··MR. RUSSELL:··Judge, do you mind if we
·7· · · ··take a ten-minute break?
·8· · · · · · · · ··JUDGE GOLDSTEIN:··I do not mind.··Why
·9· · · ··don't we just go to 11:15.
10· · · · · · · · ··MR. RUSSELL:··Sounds good.··Thank you.
12· · · · · · · · ··(Break taken at 10:57 AM)
14· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Back on the
16· · · ··and Viridis North versus Cannabis Regulatory
17· · · ··Agency, consolidated Docket Numbers 21-029794,
18· · · ··et al.··The time now is 11:16 AM.
19· · · · · · · · ··Counsel, you may continue.
21· ·Q· ··(MR. RUSSELL) Ms. Patterson, at the deposition that
22· · · ··we discussed earlier you testified that the purpose
23· · · ··of the semi-annual inspections is to ensure that
24· · · ··labs are complying with the administrative rules.
25· · · ··Do you recall that?

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·1· ·A· ··Yes, sir, I do.
·2· ·Q· ··Okay.··And is that accurate?
·3· ·A· ··Yes, sir, it is.
·4· ·Q· ··Okay.··And I believe you testified today kind of
·5· · · ··towards the end of your testimony on direct that
·6· · · ··the quality management system at the two Viridis
·7· · · ··laboratories was in disarray.··Is that correct?
·8· ·A· ··I believe so, yes.
·9· ·Q· ··Okay.··At some point in 2020 you were an LSS that
10· · · ··was overseeing Viridis Laboratories which is the
11· · · ··Lansing laboratory; correct?
12· ·A· ··In early 2020, yes, that would have been the case.
13· ·Q· ··Okay.··I'm going to show you what's been marked as
14· · · ··Exhibit 4 but will now be Exhibit 3, or proposed
15· · · ··Exhibit 3.
16· · · · · · · · ··MR. RUSSELL:··Can you make that a little
17· · · ··bigger?··There you go.
18· ·Q· ··(MR. RUSSELL) Can you see that?
19· ·A· ··Yes, I can.··Thank you, sir.
20· ·Q· ··Okay.··Do you recognize that document?
21· ·A· ··Yes, this appears to be an inspection report for
22· · · ··Viridis Laboratories, that would be the Lansing
23· · · ··location, and it would be a Semi-Annual Inspection
24· · · ··Report.
25· ·Q· ··Okay.··And is this an accurate depiction of your

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·1· · · ··report?
·2· ·A· ··If you would scroll down, please?
·3· ·Q· ··Sure.
·4· ·A· ··Yes, it does appear to be an accurate description
·5· · · ··of my report.
·6· · · · · · · · ··MR. RUSSELL:··Okay.··And, Your Honor, I'd
·7· · · ··like to move to admit that as I believe it will be
·8· · · ··now Exhibit 3.
·9· · · · · · · · ··Just leave it up there.
10· · · · · · · · ··MS. HUYSER:··No objection.
11· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Viridis
12· · · ··Exhibit 3 is admitted.
14· ·Q· ··(MR. RUSSELL) Now, Ms. Patterson, you're the
15· · · ··inspecting official on this semi-annual report;
16· · · ··correct?
17· ·A· ··Yes, sir, I am.
18· ·Q· ··Okay.··And it looks like the inspection date, at
19· · · ··least it states on the top, is July 23rd, 2020; is
21· ·A· ··I cannot see that.··If you wouldn't mind scrolling
22· · · ··up a bit I can confirm.
23· · · · · · · · ··Yes, that is correct, sir.
24· ·Q· ··Okay.··So this would seem to indicate that you went
25· · · ··into the Viridis laboratory, the Lansing

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·1· · · ··laboratory, and confirmed that the lab was
·2· · · ··complying with the administrative rules; is that
·3· · · ··right?
·4· ·A· ··I do not necessarily believe that I went into the
·5· · · ··laboratory.··And, I apologize, but given the time I
·6· · · ··believe that would have been during the height of
·7· · · ··the COVID 19 pandemic, so this was likely something
·8· · · ··that was done virtually.
·9· ·Q· ··So kind of the same medium that we're in today,
10· · · ··this type of Zoom or Teams?
11· ·A· ··Yes, sir, it would have been conducted I believe
12· · · ··via Teams.
13· ·Q· ··Okay.··And as part of that you would have asked to
14· · · ··see -- to review the quality assurance system; is
15· · · ··that true?
16· ·A· ··Yes, I would have in particular asked to review
17· · · ··their quality -- quality assurance manual,
18· · · ··essentially just their SOPs as it related to
19· · · ··quality assurance.
20· ·Q· ··And in addition to that you would have -- and maybe
21· · · ··you just said this, I'm not sure -- that you would
22· · · ··have reviewed that they had SOPs in place?
23· ·A· ··I would have reviewed that they had SOPs on file,
24· · · ··yes, in addition to those quality management
25· · · ··procedures.

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·1· ·Q· ··Okay.··And do you know if at this inspection if you
·2· · · ··watched Viridis Laboratories perform any testing?
·3· ·A· ··I cannot speak to that.··It's not recorded on here
·4· · · ··so I'm unable to answer that question.··I
·5· · · ··apologize.
·6· ·Q· ··Okay.··But you would have reviewed the quality
·7· · · ··management system; correct?
·8· ·A· ··Yes, the written documents as it relates to the
·9· · · ··quality management system, yes, sir.
10· ·Q· ··Okay.··And you would have reviewed that there was a
11· · · ··laboratory manager that was overseeing everything?
12· ·A· ··Yes, sir.
13· ·Q· ··Okay.··And so if I'm reading your inspection report
14· · · ··correctly from July 23rd, 2020, there were no
15· · · ··deficiencies that were noted during this
16· · · ··inspection; is that correct?
17· ·A· ··So it looks like there were a couple just comments
18· · · ··here, but it does state, you're correct, that no
19· · · ··deficiencies were noted.··And this would have been
20· · · ··based on the review of the existence of their
21· · · ··quality management procedures as well as their SOPs
22· · · ··related to standard everyday testing.
23· ·Q· ··Okay.··So you looked at those and you made a
24· · · ··determination that they were in compliance with the
25· · · ··administrative rules?

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·1· ·A· ··I made sure that they were in compliance with the
·2· · · ··administrative rules and that is to say that they
·3· · · ··existed.
·4· ·Q· ··Well, if there would have been an issue with
·5· · · ··anything that you reviewed you would have noted it
·6· · · ··as a deficiency; is that correct?
·8· ·Q· ··Okay.··And you didn't note a deficiency.··There
·9· · · ··were no deficiencies; correct?
10· ·A· ··That is correct, sir.
11· ·Q· ··Okay.··So would it be fair to say that you didn't
12· · · ··find any issues on July 23rd, 2020, at Viridis
13· · · ··Laboratories?
14· ·A· ··No, it appears that I did have a couple of comments
15· · · ··here, the first one being the laboratory specified
16· · · ··validation procedure must be included in the
17· · · ··laboratory protocols and procedure and that was
18· · · ··because it was inaccessible.
19· · · · · · · · ··And again I just want to add there, good
20· · · ··faith effort for the laboratory to provide that and
21· · · ··ask them to just go ahead and have that.
22· · · · · · · · ··Additionally, I noted that I would like
23· · · ··to receive a copy of all unacceptable proficiency
24· · · ··test results.··And at this point, while this was
25· · · ··not in the semi-annual inspection checklist, I did

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·1· · · ··remind the laboratory that they were to send all
·2· · · ··proficiency tests to the Agency directly from the
·3· · · ··vendor.··And that actually was specified in the
·4· · · ··administrative rules at that time but was not
·5· · · ··something that we looked for in these inspections.
·6· · · · · · · · ··Additionally, I requested that they
·7· · · ··provide corrective action for those failures and
·8· · · ··noted that this issue was not addressed.
·9· ·Q· ··So after this inspection there was no follow-up
10· · · ··required from Viridis Laboratories; is that
11· · · ··correct?
12· ·A· ··These items that you see here listed in 1 and 2,
13· · · ··those would have been requested follow-up items.
14· ·Q· ··So when a deficiency is listed, am I correct that
15· · · ··the licensee has ten days to respond to the CRA?
16· ·A· ··Yes.··So when a deficiency is noted, particularly
17· · · ··as it relates to the semi-annual inspection, they
18· · · ··have ten days to respond to the Agency with a
19· · · ··correction to any of those deficiencies noted on
20· · · ··that inspection.
21· · · · · · · · ··However, occasionally, as is evidenced
22· · · ··here in this document that has since disappeared,
23· · · ··we can see that there are occasionally issues that
24· · · ··arise outside of the realm of the semi-annual
25· · · ··inspections that would require some sort of

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·1· · · ··follow-up.··And depending on the severity of what
·2· · · ··that is, the timeline may change, and, as I stated
·3· · · ··yesterday, may end up resulting in an
·4· · · ··investigation, depending on severity.
·5· ·Q· ··Would you agree that the semi-annual inspections
·6· · · ··are one of the mechanisms that the CRA uses to
·7· · · ··ensure public health and safety?
·8· ·A· ··I -- yes, I think we could say that as evidenced by
·9· · · ··the fact that the Cannabis Regulatory Agency is
10· · · ··tasked with protecting public health and safety.
11· · · ··But in particular I want to clarify that it
12· · · ··specifically addresses compliance with the
13· · · ··administrative rules.··So I believe that that can,
14· · · ··at least in part, be inferred.
15· ·Q· ··Okay.··But it would be fair to say that the
16· · · ··administrative rules are in place to ensure public
17· · · ··health and safety; correct?
18· ·A· ··Yes, sir, absolutely.··And that's what I mean by I
19· · · ··believe it can be inferred.
20· ·Q· ··Did you also do the semi-annual inspection for
21· · · ··Viridis North in July 2020, do you know?
22· ·A· ··I do not recall.··I may have.
23· ·Q· ··Do you recall if Viridis North passed?
24· ·A· ··I -- again, I do not recall.··I'm -- they may have.
25· ·Q· ··I'm going to show you now what's been marked as

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·1· · · ··Exhibit 2 which is an email chain that you
·2· · · ··testified to a little bit yesterday.··And I'll have
·3· · · ··Lorri scroll through that just so you can see it to
·4· · · ··make sure you --
·5· ·A· ··Would you mind --
·6· ·Q· ··-- recognize it?
·7· ·A· ··I apologize.··Would you mind if we made that just a
·8· · · ··little bit bigger?
·9· ·Q· ··I agree.··Yes.
10· ·A· ··My eyes are not as good as they used to be.
11· ·Q· ··I agree.··Yep.
13· ·Q· ··Does that work?
14· ·A· ··Yes.··Thank you so much.
15· · · · · · · · ··Can we go back up to the top?··I'm so
16· · · ··sorry.
17· ·Q· ··Sure.
18· ·A· ··Thank you.··Fantastic.··I assume that was the end
19· · · ··of that document.··Is that correct?
20· ·Q· ··Yes.
21· ·A· ··Okay.··Yes, I do recognize that.
22· ·Q· ··Okay.··And is that an accurate depiction of the
23· · · ··email chain and I believe attachment that was going
24· · · ··back and forth between you and Dr. Glinn?
25· ·A· ··Yes, sir, I believe it is.

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·1· ·Q· ··And there you testified about some of this, a
·2· · · ··portion of this, yesterday; is that right?
·3· ·A· ··Yes, sir.
·4· · · · · · · · ··MR. RUSSELL:··And so I'd like to admit
·5· · · ··this which is marked as Viridis Exhibit 2 but I
·6· · · ··believe it will be Exhibit 4 now, Your Honor.
·7· · · · · · · · ··MS. HUYSER:··Are you admitting just the 1
·8· · · ··through 18 that was shown or what is the remainder
·9· · · ··of the 18 through 28 pages that we didn't scroll
10· · · ··through?
11· · · · · · · · ··MR. RUSSELL:··That's the attachment.
12· · · ··That's the SOP.··We can go through that if you'd
13· · · ··like.
14· · · · · · · · ··MS. HUYSER:··Just to make sure, not like
15· · · ··I don't --
16· · · · · · · · ··MR. RUSSELL:··Yeah, no problem.
17· · · · · · · · ··Can you go through that?
18· · · · · · · · ··THE WITNESS:··And what I actually -- I
19· · · ··apologize.··Would I be able to see the last date on
20· · · ··that email chain just so I can get a frame of
21· · · ··reference for time?
22· · · · · · · · ··MR. RUSSELL:··Sure.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Are you saying what was
24· · · ··already marked as Petitioner 2?
25· · · · · · · · ··MR. RUSSELL:··Correct, Your Honor, which

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·1· · · ··I now believe it will be -- is it 4?
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Viridis 4.
·3· · · · · · · · ··MR. RUSSELL:··4, correct, Viridis 4.
·4· · · · · · · · ··THE WITNESS:··I have a frame of reference
·5· · · ··for time.··Thank you so much.
·6· · · · · · · · ··MR. RUSSELL:··Can you go down now for
·7· · · ··Sarah?
·8· · · · · · · · ··MS. HUYSER:··Thank you.··I have no
·9· · · ··objection.
10· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Viridis 4
13· ·Q· ··(MR. RUSSELL) So, Ms. Patterson, less than four
14· · · ··months after you personally found no deficiencies
15· · · ··at the Viridis laboratory you began this potency
16· · · ··audit; is that correct?
17· ·A· ··No.··So to clarify potency audits have been
18· · · ··occurring for as long as I have been at the Agency.
19· · · ··These were formalized I believe in May of 2020 per
20· · · ··our SOP.··But I did begin conversations with
21· · · ··Viridis Laboratories in particular around that
22· · · ··period of time, yes, that is true.
23· ·Q· ··So I want to clarify.··When you say in accordance
24· · · ··with your SOP are you talking about an SOP at the
25· · · ··CRA?

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·1· ·A· ··Yes, sir, I am.
·2· ·Q· ··Okay.··And did the SOP that you're referring to at
·3· · · ··the CRA have a potency level that required an
·4· · · ··automatic audit?
·5· ·A· ··Yes, sir, it does.··I can't recall exactly when
·6· · · ··that was in there.··Obviously, you know, SOPs can
·7· · · ··go through iterations.··But I'm not entirely sure
·8· · · ··when that exact portion was added; however, we have
·9· · · ··always done potency audits, like I said, and we
10· · · ··would always use the value of 28 percent.··And then
11· · · ··that was memorialized in our standard operating
12· · · ··procedure at some point in time.··I'd have to refer
13· · · ··back to the document history in order to clarify
14· · · ··that.
15· ·Q· ··So on page 16 of the emails, there's a bottom of
16· · · ··the page and then on the following page, if you can
17· · · ··go to that, it appears that you flagged samples
18· · · ··from Metrc when you were I believe reaching out to
19· · · ··Dr. Glinn to require her to perform audits on
20· · · ··these -- potency of these samples.
21· · · · · · · · ··Sorry.··We'll get to that so you can see.
22· · · · · · · · ··Is that correct?
23· ·A· ··Thank you.··I can't say that I necessarily flagged
24· · · ··those, but one of the LSSs who was responsible for
25· · · ··reviewing this data at that time are -- they're

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·1· · · ··likely the ones that flagged these.··But yes,
·2· · · ··someone at the CRA scientific section flagged these
·3· · · ··for audit.
·4· ·Q· ··And is it true, then, that the only other person at
·5· · · ··the CRA that would have been an LSS at that time
·6· · · ··was Allyson Chirio?
·7· ·A· ··No, I believe Noah Rosenzweig actually was employed
·8· · · ··in June of 2020.
·9· ·Q· ··Do you know if Noah Rosenzweig compiled this data?
10· ·A· ··I cannot speak to who compiled that data.··Again,
11· · · ··it was one of the LSSs.
12· ·Q· ··Isn't it true that Noah Rosenzweig didn't begin at
13· · · ··the CRA until December of 2020?
14· ·A· ··Again, I can't recall.··I believe it was June of
15· · · ··2020 --
16· ·Q· ··I'm sorry --
17· ·A· ··-- but I -- go ahead.
18· ·Q· ··I apologize.··I'll strike that question.
19· · · · · · · · ··That he didn't begin overseeing Viridis
20· · · ··until December 2020 is what I meant to say.
21· ·A· ··Oh.··That I can't really tell you.··But that
22· · · ··doesn't necessarily apply to who's responsible for
23· · · ··reviewing this data.
24· · · · · · · · ··Actually, in our training program
25· · · ··reviewing method data is something that occurs

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·1· · · ··pretty early on because it's pretty easy to set the
·2· · · ··parameters and detect anomalies.··So I can't really
·3· · · ··speak to who necessarily reviewed this data.
·4· ·Q· ··Do you know who oversaw the growers that are listed
·5· · · ··there?
·6· ·A· ··Can you clarify that question?··What do you mean by
·7· · · ··oversaw?
·8· ·Q· ··Well, were the LSSs, did they have different
·9· · · ··growers that they would review the Metrc data for,
10· · · ··or how would that work?
11· ·A· ··No, sir.··So when we review the Metrc data, as I've
12· · · ··stated before, Metrc, obviously, is our statewide
13· · · ··monitoring system.··We have data analysts who are
14· · · ··trained to, essentially, pull that data directly
15· · · ··down from Metrc and then report that out to our
16· · · ··section.··And this has nothing to do with the
17· · · ··growers that are involved.··We're laboratory
18· · · ··scientist specialists, so we may be assigned
19· · · ··particular laboratories.··We are not assigned to
20· · · ··any other license type for review.
21· · · · · · · · ··MR. RUSSELL:··So if -- on page 12 if --
22· · · ··Lorri, if you want to go up.
23· ·Q· ··(MR. RUSSELL) On November 13 again you asked
24· · · ··Dr. Glinn why Viridis has not been prepping for
25· · · ··potency according to the SOP at 1 gram; is that

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·1· · · ··correct?
·2· ·A· ··I can't speak to whether or not that was myself.
·3· · · ··Obviously there's not a signature there.··But
·4· · · ··someone from my section, either myself or one of my
·5· · · ··LSS staff, did pose that question.
·6· ·Q· ··So there were other folks that were part of this
·7· · · ··email chain?
·8· ·A· ··Well, if you'll note, this is actually from the
·9· · · ··MRA-scf inbox.··So myself as well as my staff have
10· · · ··access to that inbox.
11· ·Q· ··I believe there's deposition testimony that, and it
12· · · ··appears it's correct here, that for a time there
13· · · ··were lab scientists that were sent emails from this
14· · · ··email box and not indicate their name.··Is that
15· · · ··correct?
16· ·A· ··Yes, as evidenced by this email that does appear to
17· · · ··be correct, sir.
18· ·Q· ··Okay.··So the CRA would just send out an email from
19· · · ··their general mailbox asking a question like this,
20· · · ··and the licensee wouldn't know which of the lab
21· · · ··scientists they were actually speaking with or
22· · · ··having an email conversation with; is that right?
23· ·A· ··Yes, that appears to be evidenced here.
24· ·Q· ··Yes.··And that actually changed at some point;
25· · · ··correct?

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·1· ·A· ··Yes, I believe it did.
·2· ·Q· ··Okay.··And that was because Viridis had requested
·3· · · ··that change?
·4· ·A· ··No, I don't think so.
·5· ·Q· ··So the question here is why that -- "the samples
·6· · · ··requested for the potency audit reprepped according
·7· · · ··to your SOP at 1 gram" -- sorry, I read that wrong.
·8· · · · · · · · ··MR. RUSSELL:··This isn't what I want.
·9· · · · · · · · ··Michele, can you find November 12th?
10· · · · · · · · ··Yeah.··Can you go up to page 11,
11· · · ··Dr. Glinn's response?
12· ·Q· ··(MR. RUSSELL) So in this portion of the email
13· · · ··Dr. Glinn is responding, and I believe there was a
14· · · ··question as to why the preparation was -- wasn't
15· · · ··being done at 1 gram.··And Dr. Glinn responds that
16· · · ··the SOP says approximate 1 gram, so it need not be
17· · · ··exact.
18· · · · · · · · ··Do you recall that?
19· ·A· ··I do see that here in this email, yes, sir.
20· ·Q· ··Okay.··And do you agree with what Dr. Glinn is
21· · · ··stating in this email, that the SOP stated
22· · · ··approximately a gram, not exactly 1 gram?
23· ·A· ··I agree but I think that it's a bit of a
24· · · ··mischaracterization.
25· · · · · · · · ··So their validation studies were actually

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·1· · · ··performed at 100 milligrams or one-tenth of a gram
·2· · · ··as well as 1 gram.··However, the one-tenth of a
·3· · · ··gram actually referred to concentrate samples.
·4· · · ··And, as I stated before, this verification was done
·5· · · ··for cannabis.··And I do want to say 1 milligram is
·6· · · ··incorrect.··That should be 1 gram, just as a note
·7· · · ··there.··But the verification that they performed on
·8· · · ··flower was actually done at 1 gram.··And that was
·9· · · ··something that we had questioned Michele about and
10· · · ··asked her specifically if they were going to be
11· · · ··prepping cannabis flower samples at 1 gram.··And,
12· · · ··if you recall, that's when she stated that the AOAC
13· · · ··had verified that performing these types of studies
14· · · ··on cannabis flower at 1 gram was the most
15· · · ··appropriate because that would reduce the relative
16· · · ··standard deviation in the reporting of those
17· · · ··samples.
18· · · · · · · · ··So while it does state that, and also the
19· · · ··incorrectly because it says 1 milligram instead of
20· · · ··1 gram, I understood her point, but I believe it's
21· · · ··a bit of a mischaracterization.
22· ·Q· ··Well, I'm not sure what you thought my question
23· · · ··was.
24· ·A· ··Oh.
25· ·Q· ··I was just asking whether the SOP actually said

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·1· · · ··approximately a gram.··Was that incorrect?
·2· ·A· ··Oh.··So for flower -- I apologize.··Yes, it does
·3· · · ··say approximately 1 gram.
·4· · · · · · · · ··MR. RUSSELL:··And on page 10 -- can you
·5· · · ··go to page 10?··All right.··This one here.
·6· ·Q· ··(MR. RUSSELL) So on page 10 -- and this one is
·7· · · ··signed by you.··So this one is from you; correct?
·9· ·Q· ··So you state "To be clear, we're going to need you
10· · · ··to include a more precise definition of what
11· · · ··approximate means in your SOP.··Approximate should
12· · · ··not, under reasonable circumstances, refer to prep
13· · · ··weight falling anywhere in between," and you give
14· · · ··the ranges.··Correct?
15· ·A· ··Yes, sir.
16· ·Q· ··Okay.··So I just want to make sure I have the
17· · · ··timeline correct.
18· · · · · · · · ··You had approved the SOP and the
19· · · ··validation from Viridis, but now you're directing a
20· · · ··change to the SOP?
21· ·A· ··I'm actually directing a clarification to the SOP
22· · · ··as Dr. Glinn seemed to be confused and
23· · · ··contradicting her own responses to the Agency by
24· · · ··stating that she would use 0.1 grams, a tenth of a
25· · · ··gram, all the way up to 1 gram.··What we would

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·1· · · ··require is that whatever was in the SOP was in line
·2· · · ··with what happened in the actual verification of
·3· · · ··data that was provided to us in the very beginning
·4· · · ··during the initial approval of that standard
·5· · · ··operating procedure.
·6· · · · · · · · ··So I found it necessary to clarify to her
·7· · · ··that she needed to clarify what approximate meant
·8· · · ··because she seemed to be contradicting what she had
·9· · · ··already told the Agency.
10· ·Q· ··So you asked for an updated SOP; correct?
11· ·A· ··I asked for her to clarify what the definition of
12· · · ··approximate is in her SOP, yes, sir.
13· ·Q· ··Okay.··And on page 10 on November 24th, 2020,
14· · · ··Dr. Glinn states "Attached," which I believe is at
15· · · ··the bottom of this email chain, "please find the
16· · · ··Lansing potency audit retest materials.··I include
17· · · ··chromatograms, a summary spreadsheet and updated
18· · · ··version of our method with acceptable weight ranges
19· · · ··specified.··Bay City's data to follow in the next
20· · · ··email."
21· · · · · · · · ··Would you agree that you received an
22· · · ··updated SOP from Dr. Glinn on November 24th, 2020?
23· ·A· ··Yes.··As it relates to the SOP that's at the bottom
24· · · ··of this email, yes, she did provide that.
25· ·Q· ··Okay.··Look at page 9 on December 2nd.

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·1· · · · · · · · ··MR. RUSSELL:··Back down.··There we go.
·2· · · · · · · · ··THE WITNESS:··If you would go down just a
·3· · · ··little bit, please.··Thank you so much.
·4· ·Q· ··(MR. RUSSELL) You state in this email "Ultimately I
·5· · · ··have some concerns about the number of high potency
·6· · · ··results coming from Bay City and Lansing.··And
·7· · · ··looking at data on our end the number of flower
·8· · · ··samples that exceed 30 percent are coming from the
·9· · · ··Viridis Laboratories primarily."··You go on to say
10· · · ··that you believe something is amiss; correct?
11· ·A· ··Yes, sir, that is correct, likely during sample
12· · · ··preparation.
13· ·Q· ··So at this point Viridis has an approved SOP which
14· · · ··I believe you have indicated is the May 20, 2020,
15· · · ··SOP which you had required an update back then;
16· · · ··correct?
17· ·A· ··Yes, sir.
18· ·Q· ··Okay.··And then in this email chain in November
19· · · ··2020 you again requested an update to the SOP; is
21· ·A· ··Again, I want to specify that these are quite
22· · · ··different circumstances that we requested an
23· · · ··update.
24· ·Q· ··It's a yes or no question.··I'd appreciate it if
25· · · ··you just answer the question.

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·1· · · · · · · · ··Did you or did you not request an updated
·2· · · ··SOP?
·3· ·A· ··I did request that they clarify here what the term
·4· · · ··approximate means for their SOP, that is correct.
·5· ·Q· ··And you received an updated SOP; correct?
·6· ·A· ··Yes, I did.
·7· ·Q· ··Similarly to what you did in May of 2020?
·8· ·A· ··Different but nonetheless.
·9· ·Q· ··Let's go to page 5.
10· · · · · · · · ··So you testified yesterday that the first
11· · · ··time you learned about the ceramic balls being put
12· · · ··into the methanol extract vial was in June of 2021;
14· ·A· ··Yes, sir.··That's the first time that it was in the
15· · · ··SOP.··That I believe is what I testified to.
16· ·Q· ··And I think you testified today that was the first
17· · · ··time that you were aware that they were doing that.
18· · · ··Correct?
19· ·A· ··It was the first time that I saw it in the SOP,
20· · · ··yes, sir.
21· ·Q· ··Okay.··And in this email from Dr. Glinn, in
22· · · ··responding to one of your questions, I think your
23· · · ··question is "How is the resin freed from the
24· · · ··ceramic balls," their response is "With a
25· · · ··disposable plastic spatula or by rinsing in

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·1· · · ··methanol in an extraction vial.··We have done it
·2· · · ··both ways."
·3· · · · · · · · ··Is that correct?
·4· ·A· ··Yes, sir, that is -- that is correct.··And there's
·5· · · ··an important distinction to note there as well.
·6· · · · · · · · ··MR. RUSSELL:··You can take it down.
·7· ·Q· ··(MR. RUSSELL) So at this point you had this email
·8· · · ··communication back and forth with Dr. Glinn --
·9· ·A· ··Uh-huh.
10· ·Q· ··-- you received an updated SOP that you testified
11· · · ··you received --
12· ·A· ··Yes, sir.
13· ·Q· ··-- and you never responded to Dr. Glinn as it
14· · · ··related to the SOP; correct?
15· ·A· ··So I responded by asking additional questions.··To
16· · · ··clarify, the SOP was not responded to formally
17· · · ··because they did not submit a validation which
18· · · ··would be required for the submission of this SOP.
19· · · · · · · · ··What Dr. Glinn had, well, done, frankly,
20· · · ··during this point in time is she submitted an SOP
21· · · ··that did address -- well, in part -- my concerns.
22· · · ··She defined loosely the term approximate to range
23· · · ··from 0.4 grams to 1.2 grams.··Again, unacceptable
24· · · ··because that's not where the verification was

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·1· · · · · · · · ··But she additionally stated that they
·2· · · ··were going to homogenize the samples, scrape the
·3· · · ··top, bottoms, and sides of the jar as well as the
·4· · · ··ceramic grinding media.
·5· · · · · · · · ··Now, scraping the ceramic grinding media
·6· · · ··in and of itself would have, essentially,
·7· · · ··introduced nonhomogeneous clumps of trichomes that
·8· · · ··are all clumped together.
·9· · · · · · · · ··Another thing that I found very
10· · · ··interesting and, in fact, a little bit concerning
11· · · ··in this SOP update was that they stated that they
12· · · ··were going to potentially, for noncompliance
13· · · ··samples only that contained a very small amount of
14· · · ··flower material, they were going to drop those
15· · · ··grinding media directly into the extraction vial,
16· · · ··or, rather, add the extraction solution directly to
17· · · ··the vial where that homogenization had occurred.
18· · · · · · · · ··So if we refer back to that email that
19· · · ··you were just showing me I believed that she was
20· · · ··referring to the two separate pathways that that
21· · · ··sample preparation could take from a compliance
22· · · ··sample, which would be done, well, in theory,
23· · · ··homogeneously, though not with the inclusion of the
24· · · ··scraped material from the ceramic balls or through
25· · · ··the noncompliance pathway but adding the extraction

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·1· · · ··solution directly to the homogenization vial
·2· · · ··itself.
·3· ·Q· ··So it appears from your testimony you had a lot of
·4· · · ··opinions about the information that was provided by
·5· · · ··Dr. Glinn?
·6· ·A· ··No, sir, these are not opinions, they're questions.
·7· ·Q· ··Okay.··And so to go back to my question, you never
·8· · · ··responded to the SOP that was provided by
·9· · · ··Dr. Glinn; is that correct?··You never rejected it?
10· · · ··You never accepted it?··You never responded?
11· ·A· ··Oh, correct, because it was not submitted
12· · · ··appropriately as would be required for a method of
13· · · ··this nature.
14· · · · · · · · ··I did, however, respond with additional
15· · · ··questions to let them know that we were still
16· · · ··trying to figure out exactly what was going on here
17· · · ··to substantiate these additional changes to the
18· · · ··standard operating procedure.
19· ·Q· ··So Dr. Glinn in the exact same procedure that had
20· · · ··happened in May 2020 gets a request from you for an
21· · · ··updated SOP, provides it to you.··The only
22· · · ··difference is you never respond in any manner to
23· · · ··Dr. Glinn as it relates to the updated SOP?
24· ·A· ··Oh, no, sir.··This is actually a very different
25· · · ··circumstance.··As I stated before, in May of 2020

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·1· · · ··the laboratory themselves have identified that they
·2· · · ··needed to clarify the term homogenization, and they
·3· · · ··did that in the May of 2020 method.··They simply
·4· · · ··further defined accurately the term homogenization
·5· · · ··for their staff to ensure that the staff were
·6· · · ··performing this method consistently.
·7· · · · · · · · ··However, as we see here in the November
·8· · · ··2020 method, they added a significant change to the
·9· · · ··range of approximate related to 1 gram of ground
10· · · ··flower material.··They also began scraping very
11· · · ··nonhomogeneous material from the ceramic grinding
12· · · ··media into homogenized material thereby making it
13· · · ··nonhomogeneous.··And they added this interesting
14· · · ··portion about noncompliance samples and adding the
15· · · ··ceramic grinding media along with the ground flower
16· · · ··to the extraction vial itself or taking the
17· · · ··extraction liquid and adding it to the vial that
18· · · ··those things were homogenized in themselves.
19· · · · · · · · ··So this is actually a significant
20· · · ··addition to the standard operating procedure as
21· · · ··opposed to a clarification of a word to ensure
22· · · ··consistency among technicians.
23· ·Q· ··Well, the noncompliance samples would be for R&D
24· · · ··purposes, not for testing; correct?
25· ·A· ··No, sir.··And, to be fair, that's not clarified

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·1· · · ··here.··I would refer a noncompliance sample as a
·2· · · ··sample that were -- or was something that they
·3· · · ··received from the nonregulated market.··And, to be
·4· · · ··clear, that would be someone like a patient or a
·5· · · ··caregiver.··At this time it probably could have
·6· · · ··also been an adult use or recreational consumer.
·7· · · · · · · · ··Also we would not allow a laboratory to
·8· · · ··test R&D samples any differently than we would
·9· · · ··allow them to test their typical samples in full
10· · · ··compliance testing.··That would certainly provide
11· · · ··nonharmonious results and is something that we
12· · · ··would never ever permit for a laboratory to do.
13· · · ··And if that were the case, we would certainly
14· · · ··require an additional validation of that step being
15· · · ··something that they would include in their standard
16· · · ··operating procedure.
17· · · · · · · · ··All samples should be tested the same way
18· · · ··all the time from client to client.··Every single
19· · · ··client should be treated the same no matter whether
20· · · ··it's a compliance regulated sample, an R&D sample.
21· · · · · · · · ··And, to be frank with you, if they're
22· · · ··doing testing for folks like patients and
23· · · ··caregivers they should be testing those samples in
24· · · ··the same way that they would for the regulated
25· · · ··market.··Otherwise it mischaracterizes the testing

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·1· · · ··that they're doing, and it shows us that they're
·2· · · ··not doing these things consistently which therefore
·3· · · ··brings question to the results that the
·4· · · ··laboratory's reporting, and that's seriously
·5· · · ··concerning.
·6· ·Q· ··So, again, you never rejected the SOP that was sent
·7· · · ··to you by Dr. Glinn?
·8· ·A· ··Sir, I did not reject the SOP because it was not
·9· · · ··submitted to me in the appropriate fashion.··I
10· · · ··continued and followed up by asking additional
11· · · ··questions at the laboratory.
12· ·Q· ··And the Viridis North and Viridis Laboratories
13· · · ··would have no idea that it wasn't submitted as you
14· · · ··claim is the appropriate fashion; correct?
15· ·A· ··Yes, they very well should.··They made significant
16· · · ··substantive changes to the standard operating
17· · · ··procedure, and they should very well know that
18· · · ··these type of hypotheses would require validation.
19· ·Q· ··And there's nowhere that they could look in your
20· · · ··procedures or rules that would state that; correct?
21· ·A· ··I would hope that their experience in the Michigan
22· · · ··State Police would provide them this information.
23· · · · · · · · ··MR. SCHUMACHER:··The answer is yes.
24· ·Q· ··(MR. RUSSELL) So the answer is yes?
25· ·A· ··Reframe the question, please, sir.

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·1· ·Q· ··So there would be somewhere in your -- your
·2· · · ··procedures or the administrative rules where they
·3· · · ··could look so they would know that they had to
·4· · · ··provide this; correct?
·5· ·A· ··No.··But, again, they would be able to refer to one
·6· · · ··of us and ask questions as they had always done in
·7· · · ··the past when they were seeking to get a method
·8· · · ··approved through the Agency.
·9· ·Q· ··You were -- the CRA was receiving complaints from
10· · · ··other safety compliance facilities about Viridis;
11· · · ··correct?
12· ·A· ··The CRA, yes, consistently receives complaints from
13· · · ··safety compliance facilities.
14· ·Q· ··But specifically you were receiving complaints from
15· · · ··other safety compliance facilities about Viridis;
16· · · ··correct?
17· ·A· ··Yes, we had received complaints from other safety
18· · · ··compliance facilities about Viridis.
19· ·Q· ··And the general complaint that you're receiving is
20· · · ··that they're inflating potency; is that correct?
21· ·A· ··That they're inflating potency and also that
22· · · ··they're passing microbials that should be failed.
23· ·Q· ··Okay.··Well -- and I understand, we'll get into
24· · · ··microbials, but I'm just talking about potency for
25· · · ··this.··I just want to confirm.

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·1· · · · · · · · ··So you've received -- you're receiving
·2· · · ··complaints from other safety compliance facilities
·3· · · ··about potency; correct?
·4· ·A· ··Yes, sir, we did.
·5· ·Q· ··Okay.··And they were complaining about Viridis
·6· · · ··North and Viridis Laboratories' potency results
·7· · · ··because they were higher than what the results that
·8· · · ··they thought they should be; correct?
·9· ·A· ··Yes, that is loosely correct.
10· ·Q· ··And yesterday you talked a lot about high potency.
11· · · ··You almost put a definition on it, that -- their
12· · · ··high potency you kept referring to, and I believe
13· · · ··you stated you based that off of two things.··I
14· · · ··think you stated it was scientific literature and
15· · · ··also the -- the industry, meaning the Michigan
16· · · ··safety compliance facilities.··Is that correct?
17· ·A· ··No, it was based on scientific literature,
18· · · ··specifically Jikomes and Zoorob 2018 article as
19· · · ··well as a Meyer's article and several other
20· · · ··scientific articles that state that any potency
21· · · ··exceeding I believe it is 27 percent falls in the 1
22· · · ··percentile, so -- well, the 99th percentile
23· · · ··rather -- and is incredibly unusual.
24· ·Q· ··So it's your testimony that it was a Nature article
25· · · ··which is a scientific journal; is that correct?

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·1· ·A· ··Yes, Nature is a scientific article -- or a
·2· · · ··scientific journal, excuse me.··The Jikomes and
·3· · · ··Zoorob article of 2018 is from I believe Nature or
·4· · · ··Frontiers.··I'd have to look at the publisher.
·5· ·Q· ··Okay.··So it's your testimony that you relied on
·6· · · ··those two articles to make a determination as to
·7· · · ··what was high potency.
·8· ·A· ··Yes, the -- well, that's in addition to other
·9· · · ··available scientific literature, books related to
10· · · ··the biochemistry of cannabinoid synthesis in the
11· · · ··plants.··But yes, that seemed to be the consensus
12· · · ··based on scientific literature.
13· ·Q· ··Please provide me with the names of the other
14· · · ··articles that you relied on.
15· ·A· ··Oh, sir, I cannot do that off the top of my head.
17· · · · · · · · ··JUDGE GOLDSTEIN:··At this point we're
18· · · ··going to break for lunch.··We will reconvene at
19· · · ··1:10 today.
20· · · · · · · · ··I just have one last question,
21· · · ··Ms. Patterson.··I'm trying to understand this
22· · · ··potency limitation.
23· · · · · · · · ··THE WITNESS:··Yes, sir.
24· · · · · · · · ··JUDGE GOLDSTEIN:··Or maybe the 1 percent
25· · · ··you just discussed.

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·1· · · · · · · · ··Are you talking about the cannabis plant
·2· · · ··in its natural form without being adulterated or --
·3· · · · · · · · ··THE WITNESS:··Yes, exactly.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··-- having THC added to
·5· · · ··it?
·6· · · · · · · · ··In its natural form a cannabis plant can
·7· · · ··only contain or produce so much percentage THC?··Is
·8· · · ··that the premise here?
·9· · · · · · · · ··THE WITNESS:··Yes.··Yes.··So that is the
10· · · ··premise here.··And it's not to say that the
11· · · ··cannabis plant doesn't or is completely incapable
12· · · ··of producing higher amounts of THC, for example, in
13· · · ··the 30 percent range, but it's incredibly rare.··So
14· · · ··that would be what we would consider the 99th
15· · · ··percentile.··And that's due to the actual
16· · · ··biochemical limitations and energetic reserves that
17· · · ··the cannabis plant has available to it in order to
18· · · ··produce those cannabinoids and those compounds.
19· · · · · · · · ··So, again, I want to reiterate it's not
20· · · ··impossible to exceed, it's just exceedingly rare.
21· · · · · · · · ··JUDGE GOLDSTEIN:··So it has a limitation
22· · · ··to what it's naturally able to produce in terms of
23· · · ··potency?
24· · · · · · · · ··THE WITNESS:··Yes, sir, that is correct.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··All right.··I

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·1· · · ··just wanted to make sure I was getting that
·2· · · ··correctly.
·3· · · · · · · · ··THE WITNESS:··Thank you, Your Honor.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··So at this point we'll
·5· · · ··reconvene at 1:10.··We're off the record now at
·6· · · ··11:58 AM.
·8· · · · · · · · ··THE WITNESS:··Thank you.
·9· · · · · · · · ··(Break taken at 11:58 AM)
11· · · · · · · · ··JUDGE GOLDSTEIN:··Back on the record in
12· · · ··the matter of Viridis Laboratories, LLC, and
13· · · ··Viridis North versus Cannabis Regulatory Agency,
14· · · ··consolidated Dockets 21-029794, et al.··The time is
15· · · ··1:13 PM.
16· · · · · · · · ··Counsel, you had a comment you want to
17· · · ··make?
18· · · · · · · · ··MR. RUSSELL:··Yes, Judge, just a
19· · · ··scheduling matter.··Yesterday I had indicated to
20· · · ··the Tribunal that I was hoping to conclude today at
21· · · ··4:00.··My daughter has a lacrosse game at five.··I
22· · · ··had asked this morning the attorney generals if
23· · · ··they had any objection, which they indicated they
24· · · ··didn't.··So Ms. Hunt-Scully reminded me about that
25· · · ··and wanted me just to confirm with the Court that

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·1· · · ··that was the schedule for today.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··That's fine with the
·3· · · ··Tribunal.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··We'll have plenty to do
·6· · · ··all the way up until you leave.
·7· · · · · · · · ··So we'll adjourn at four today.··If
·8· · · ··the -- we're set to meet next week I think in this
·9· · · ··case as well.
10· · · · · · · · ··MR. RUSSELL:··That's correct, Judge.··I
11· · · ··believe Tuesday and Wednesday next week.
12· · · · · · · · ··MR. SCHUMACHER:··Yeah.
13· · · · · · · · ··JUDGE GOLDSTEIN:··So on any of these
14· · · ··hearing days that you don't want to go directly
15· · · ··till five, if you can bring it to my attention, we
16· · · ··can adjourn earlier than that.··Okay?
18· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Any other
19· · · ··preliminary matters before we continue?
20· · · · · · · · ··MR. RUSSELL:··Not from Viridis.
22· · · · · · · · ··MS. HUNT-SCULLY:··We do not.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel for Viridis,
24· · · ··you may continue.

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·1· ·Q· ··(MR. RUSSELL) Ms. Patterson, before we took a break
·2· · · ··for lunch you had testified about some scientific
·3· · · ··literature that you relied on for this I think you
·4· · · ··stated a 1 percent over a certain potency amount, I
·5· · · ··think you said 27 percent.··Do you recall that?
·6· ·A· ··Yes, I recall that conversation.
·7· ·Q· ··Okay.··And I know that you had -- I believe you
·8· · · ··testified that one of the articles was a Nature
·9· · · ··article.··Was that right?
10· ·A· ··Yes, I said I believe it was either Nature or
11· · · ··Frontiers.··I'd have to refer back to the article
12· · · ··itself.
13· ·Q· ··Okay.··And I think I'm familiar with that article,
14· · · ··but the other one I believe you stated was authored
15· · · ··by a Meyer was the last name, M-e-y-e-r.··Is that
16· · · ··correct?
17· ·A· ··Yes, sir, in addition to a number of other
18· · · ··references that I could not recall off the top of
19· · · ··my head.
20· ·Q· ··And the Meyer article, do you recall the title of
21· · · ··that article?
22· ·A· ··Off the top of my head I do not.
23· ·Q· ··Do you recall the year it was published?
24· ·A· ··No, sir, I do not.
25· ·Q· ··Do you know a time frame that it was published?

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·1· ·A· ··No, sir, I do not.
·2· ·Q· ··Okay.··Do you know if this Meyer was the only
·3· · · ··author of that article?
·4· ·A· ··I don't believe so, but I can't recall the other
·5· · · ··authors.
·6· · · · · · · · ··To be frank with you, I have a list of
·7· · · ··scientific articles, resources, books that I've
·8· · · ··referred to in order to set this parameter for the
·9· · · ··Agency based on the available scientific
10· · · ··literature.
11· ·Q· ··All right.··I'm going to ask you about -- you
12· · · ··testified yesterday about this December 2020
13· · · ··semi-annual inspection that occurred.··Do you
14· · · ··recall that?
15· ·A· ··Yes, sir.
16· ·Q· ··Okay.··I'm going to show you what's been previously
17· · · ··marked as Exhibit 5 and will now be Exhibit --
18· · · ··Exhibit 5 actually.
19· ·A· ··Would you mind enlarging that for me, please?
20· · · · · · · · ··That's perfect.··Thank you so much.
21· ·Q· ··Okay.··Let's scroll through that so you can review
22· · · ··it.
23· · · · · · · · ··Do you recognize those documents?
24· ·A· ··Yes, sir, I do.
25· ·Q· ··Okay.··And what are those documents?

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·1· ·A· ··This -- well, as a collective document is a
·2· · · ··Semi-Annual Inspection Report.
·3· ·Q· ··Okay.··For both the Viridis laboratories?
·4· ·A· ··This one in particular appears to be for Viridis
·5· · · ··Laboratories.··They may have been performed at the
·6· · · ··same time, but based on the top and the heading
·7· · · ··here it says Viridis Laboratories.··Oh, and it does
·8· · · ··have its ERG number, so I suppose that would
·9· · · ··indicate that it was both licenses.
10· ·Q· ··Well, they're actually -- I'm not trying to trick
11· · · ··you -- the exhibit had both, so I just want to make
12· · · ··sure you see that.
13· · · · · · · · ··So, yes, the first that you identified
14· · · ··was for Viridis Laboratories and then as part of
15· · · ··that is Viridis North.··So they are two separate
16· · · ··documents but it's one exhibit.··I just want you
17· · · ··to --
18· ·A· ··Oh, okay.··I apologize.··I did miss that, and I
19· · · ··appreciate the clarification, sir.
20· ·Q· ··Okay.··So I think you just testified that you
21· · · ··recognize the Semi-Annual Inspection Report for
22· · · ··Viridis Laboratories, and we'll scroll through this
23· · · ··Viridis North one as well to make sure that you
24· · · ··recognize this.
25· ·A· ··Thank you.··Yes, sir, I recognize that.··Thank you.

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·1· ·Q· ··Okay.··And is that an accurate depiction of those
·2· · · ··inspection reports?
·3· ·A· ··Yes, sir, I believe so.
·4· · · · · · · · ··MR. RUSSELL:··Okay.··Your Honor, I would
·5· · · ··move to have this admitted as Exhibit 5.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Viridis Exhibit 5 is
10· ·Q· ··(MR. RUSSELL) So, Ms. Patterson, I want to direct
11· · · ··your attention on page 6 of 9.··And I believe this
12· · · ··relates to the Lansing laboratory's inspection
13· · · ··reports, but my understanding is these were both
14· · · ··the same.
15· · · · · · · · ··And looking --
16· ·A· ··I -- yes, I agree they're both the same.
17· · · · · · · · ··I apologize, Mr. Russell.
18· ·Q· ··Sorry, I kind of talked over you.
19· · · · · · · · ··And so Number 12 here specifically is one
20· · · ··I want to ask you about.
21· · · · · · · · ··So am I correct that as part of this
22· · · ··semi-annual inspection the CRA found there were
23· · · ··other deficiencies, but I want to specifically ask
24· · · ··you about this Number 12 related to -- and I
25· · · ··believe it's -- there's inspector's comments and

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·1· · · ··then there was under that I believe was the
·2· · · ··response from Viridis, and then there's a response,
·3· · · ··"Accepted, LSS will follow up on a next
·4· · · ··inspection," and below that I believe is the
·5· · · ··deficiency.
·6· · · · · · · · ··Am I right about that?
·7· ·A· ··So what it appears to me is that we have the rule
·8· · · ··which is stated, as you said, in Number 12.··There
·9· · · ··are some inspection -- or inspector, excuse me,
10· · · ··comments there which means that, essentially, those
11· · · ··comments would refer to what is directly written in
12· · · ··the rule.··And then it appears that there are some
13· · · ··additional comments below that related to potency
14· · · ··SOPs.
15· ·Q· ··Okay.··But -- and so -- but what I'm trying to make
16· · · ··sure that I am trying to confirm then is where it
17· · · ··says "Laboratory written SOPs must include approval
18· · · ··signature date," do you see where I'm reading right
19· · · ··there?
20· ·A· ··Oh.··Yes, I do.
21· ·Q· ··Okay.··And so that -- my understanding is that
22· · · ··would have been from the lab scientist.··I believe
23· · · ··it was Noah Rosenzweig did the inspection, so I'm
24· · · ··assuming that would have been him, and that would
25· · · ··have been the noted deficiency related back to the

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·1· · · ··rule that's cited above.··Is that right?
·2· ·A· ··So that would have been, essentially, a
·3· · · ··notification to the laboratory that there was a
·4· · · ··deviation there despite the fact that it may not
·5· · · ··necessarily align with the exact language of the
·6· · · ··rule.··And I think I mentioned this a little bit
·7· · · ··yesterday as well, and I'm happy to go into further
·8· · · ··detail if needed.
·9· ·Q· ··Well, I just want to confirm that my belief is
10· · · ··right that there's been a deficiency noted.
11· ·A· ··So it's not that there's a deficiency noted with
12· · · ··the checklist and the rules themselves.··And I
13· · · ··guess I'll go ahead and get into that.
14· · · · · · · · ··So the administrative rules, as I've
15· · · ··said, our checklists are based specifically on the
16· · · ··administrative rules in effect at that time and
17· · · ··what in particular is enforceable.
18· · · · · · · · ··So I believe that this comment here is a
19· · · ··note that technically, in accordance with the rule,
20· · · ··Viridis is maintaining internal standard operating
21· · · ··procedures for the required safety tests in sub
22· · · ··rule 3, etc.··However, it appears that Noah has or
23· · · ··Dr. Rosenzweig has noted that laboratory written
24· · · ··SOPs must include approval by appropriate staff and
25· · · ··approval form provided by MRA at that time prior to

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·1· · · ··implementation of new or revised methods.
·2· · · · · · · · ··So that would be a notification to the
·3· · · ··laboratory that they were doing something that
·4· · · ··essentially was not in alignment with what they
·5· · · ··would need to do related to receiving approval for
·6· · · ··the methods that they had implemented in practice
·7· · · ··in the laboratory space.··So it is a -- there's a
·8· · · ··bit of a deviation there.
·9· ·Q· ··So it's an issue, a noted deficiency of the rule.
10· · · ··And I believe that's what you testified to at your
11· · · ··deposition.
12· ·A· ··So it's not that it's a -- it's not that it's a
13· · · ··deficient semi-annual inspection, but there's an
14· · · ··additional part of it that is not in compliance
15· · · ··with the administrative rules, and that's where the
16· · · ··distinction lies.··And I can see where that -- that
17· · · ··may be a little confusing, so I'm happy to explain
18· · · ··further as needed.
19· ·Q· ··Yeah, we'll get into it a little bit, but I just
20· · · ··want to make sure, and I'm not trying to trick you,
21· · · ··but the rule is cited.
22· · · · · · · · ··You've testified that you don't believe
23· · · ··that in December 2020 that the method that was
24· · · ··being used by the two Viridis Labs was under an
25· · · ··approved SOP and -- is that right?

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·2· ·Q· ··Okay.··And so for the two December 22nd, 2020,
·3· · · ··semi-annual inspections you didn't go in person but
·4· · · ··through Zoom or some other Teams, some kind of
·5· · · ··media you watched, not you particularly but your
·6· · · ··lab scientists, watched Viridis Laboratories and
·7· · · ··Viridis North conduct their potency method?
·8· ·A· ··Yes, sir.··And so that's, again, where I think that
·9· · · ··important distinction is.··So the sampling and
10· · · ··testing rule that's stated here requires that the
11· · · ··laboratory simply maintain internal standard
12· · · ··operating procedures.··And at that time Viridis did
13· · · ··maintain an internal standard operating procedure,
14· · · ··especially for potency.··It was the May of 2020
15· · · ··method.
16· · · · · · · · ··However, what Noah is noting here is in
17· · · ··addition to the semi-annual inspection, and that's
18· · · ··where he's stating that the licensee must receive
19· · · ··approval from the Agency to use a new method in
20· · · ··their laboratory space.
21· ·Q· ··Right.··So it was the contention in the deficiency
22· · · ··that the two Viridis laboratories were in violation
23· · · ··of the rule for not using an approved SOP?
24· ·A· ··So it's not a semi-annual inspection deficiency
25· · · ··here in 2020.··It's still a rule violation though.

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·1· · · ··And I want to clarify that those are really two
·2· · · ··separate things.
·3· ·Q· ··Right.··So he's noting a rule violation.··I mean --
·4· ·A· ··Yes.
·5· ·Q· ··And that's what I believe you testified to at your
·6· · · ··deposition is the semi-annual inspections were to
·7· · · ··confirm that the safety compliance facility was
·8· · · ··operating in conformance with the rules.
·9· ·A· ··So, again, the semi-annual inspections are a -- a
10· · · ··checklist, and that checklist is formed from the
12· · · · · · · · ··Now, there are additional administrative
13· · · ··rules that the licensee is still subject to follow,
14· · · ··but those may not have been captured and clearly
15· · · ··here were not captured in the semi-annual
16· · · ··inspection checklist.
17· · · · · · · · ··So I really just want to clarify that the
18· · · ··semi-annual inspection checklist is essentially a
19· · · ··snippet of the administrative rules, but there may
20· · · ··be additional rule violations that are identified
21· · · ··outside of that semi-annual checklist.
22· ·Q· ··So Mr. Rosenzweig identifies what he believes is
23· · · ··that because he watched the two Viridis
24· · · ··laboratories perform the potency method.··He would
25· · · ··have had their approved SOP for the method that the

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·1· · · ··CRA was now contending was their approved SOP, and
·2· · · ··he would have seen them perform their method in
·3· · · ··compliance with a different SOP; is that right?
·4· ·A· ··So yes, he has a copy of the SOP, the May 2020 SOP
·5· · · ··that was on file.
·6· · · · · · · · ··Now, to be fair, Viridis maintained that
·7· · · ··SOP; however, they clearly had made changes to it
·8· · · ··that they were using here in practice, and that's
·9· · · ··the violation that Noah had noted here in this
10· · · ··inspection report.
11· ·Q· ··And I think you testified to this a little bit
12· · · ··earlier.··When there's a deficiency noted the
13· · · ··laboratory, any laboratory, not just Viridis, would
14· · · ··have -- or is required within ten days to file a
15· · · ··response.··Is that right?
16· ·A· ··If it's related to a semi-annual inspection
17· · · ··deficiency, yes, we do put a ten-day, I believe
18· · · ··business day, time line for turnaround on that.··If
19· · · ··it's investigatory, again, it follows a bit of a
20· · · ··different pathway.
21· ·Q· ··And I'll show this in a separate document because I
22· · · ··believe there was a separate actual written
23· · · ··document that was sent to Mr. Rosenzweig from the
24· · · ··Viridis Laboratories with this in it.··But I
25· · · ··believe what happened was that they received the

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·1· · · ··inspection report, they prepared the -- or some --
·2· · · ··some version of the inspection report, they
·3· · · ··prepared the response, and then the final
·4· · · ··inspection report is provided which includes the
·5· · · ··response from the labs.
·6· · · · · · · · ··Am I right about that?
·7· ·A· ··I believe so.··That sounds correct, yes, sir.
·8· ·Q· ··Okay.··So what I'm looking at under inspector's
·9· · · ··comments where it says "The procedure has not
10· · · ··changed.··Staff training and standardization of
11· · · ··sample handling were conducted to improve
12· · · ··consistency between laboratories in 2020.
13· · · ··Additional sample handling details were added to
14· · · ··the procedure at the request of the MRA and sent to
15· · · ··them on December 3rd."
17· ·A· ··Yes, sir, you did.
18· ·Q· ··Okay.··And so this December 3rd update was the
19· · · ··December 3rd that you and I discussed earlier that
20· · · ··was sent to you actually I think twice, on November
21· · · ··20th and December 3rd, the updated SOP; correct?
22· ·A· ··I'm not entirely sure what this is referring to,
23· · · ··no.
24· ·Q· ··Okay.··So in your deposition testimony I think you
25· · · ··agreed with me that this was, in fact, what it was

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·1· · · ··referring to.··Are you now disputing that, that
·2· · · ··this isn't what they're referring to?
·3· ·A· ··I don't recall, sir.
·4· ·Q· ··Okay.··So I get it that you want to disavow the
·5· · · ··fact that you received the November 2020 and the
·6· · · ··December 3rd, 2020, SOP but you did, in fact.··You
·7· · · ··have testified to that effect; correct?
·8· ·A· ··I did receive the December 2020 method.
·9· · · ··Absolutely.··What I'm saying --
10· ·Q· ··Okay.
11· ·A· ··-- is that I don't know that this is what this
12· · · ··refers to, that is all.
13· ·Q· ··Okay.··But you know for a fact that Mr. Rosenzweig
14· · · ··watched the two laboratories conduct potency
15· · · ··testing in compliance with that SOP, the December
16· · · ··3rd, 2020, SOP; correct?
17· ·A· ··I would have to see the December 2020 method.··I
18· · · ··would have to also see what it is that they
20· · · · · · · · ··I believe that they did scrape the
21· · · ··ceramic grinding media, but that is not in
22· · · ··compliance with the May of 2020 method.··There is a
23· · · ··deviation there.
24· ·Q· ··So it says -- and it goes on to say "We'll be happy
25· · · ··to resend it if necessary.··Successful PT results

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·1· · · ··from December were forwarded to the MRA following
·2· · · ··the Lansing laboratory.··The -- basically, the
·3· · · ··laboratory is in the process of doing a proficiency
·4· · · ··test for 2021 and will have results forwarded as
·5· · · ··soon as they are available."
·7· ·A· ··Yes, sir, you did.
·8· ·Q· ··Okay.··And then it says "Response accepted.··LSS
·9· · · ··will follow up on next inspection."
11· ·A· ··Yes, sir, you did.
12· ·Q· ··Okay.··And I believe the response accepted would
13· · · ··have been the response from the CRA.··Correct?
14· ·A· ··Yes, sir, particularly Dr. Rosenzweig.
15· ·Q· ··Okay.··So deficiency noted.··The Viridis
16· · · ··laboratories state no, the procedure hasn't
17· · · ··changed.··We're complying with the updated SOP that
18· · · ··was sent to you on December 3rd.··Happy to resend
19· · · ··if necessary.··Response accepted by Mr. Rosenzweig.
20· · · ··Correct?
21· ·A· ··Yes, that is what that says.
22· ·Q· ··Okay.··And then passed.··Both of them passed?
23· ·A· ··Yes.
24· ·Q· ··Viridis Laboratories passed, Viridis North passed;
25· · · ··correct?

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·2· ·Q· ··Okay.··So from a timeline perspective, at this
·3· · · ··point we know November 2020 you specifically asked
·4· · · ··Dr. Glinn for an updated SOP?
·5· ·A· ··Uh-huh.
·6· ·Q· ··She provides you an updated SOP November 24, 2020,
·7· · · ··and again on December 3rd, 2020.
·8· · · · · · · · ··Am I correct about that?
·9· ·A· ··Yes, sir, I believe those dates are correct.
10· ·Q· ··Okay.··And in between December -- or November and
11· · · ··December 2020 to the date of this semi-annual
12· · · ··inspection you've never sent anything to Dr. Glinn
13· · · ··or told Dr. Glinn that those updated SOPs have been
14· · · ··rejected; correct?
15· ·A· ··Correct.··I continued to ask her questions, as I
16· · · ··previously stated, and then I had neither rejected
17· · · ··or accepted the method as it was submitted.
18· ·Q· ··And so fast-forward to the -- this December 22nd,
19· · · ··2020, semi-annual inspection.··Mr. Rosenzweig views
20· · · ··via Teams or Zoom, whatever may be the case, both
21· · · ··laboratories conducting their potency testing and
22· · · ··notes a deficiency.··They state that they're using
23· · · ··this method from December 3rd that was sent to you,
24· · · ··it's accepted, and both labs pass the semi-annual
25· · · ··inspection; correct?

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·1· ·A· ··Well, to clarify, I can't speak to the method being
·2· · · ··accepted.··As I stated, we received the SOP.··The
·3· · · ··method was neither accepted nor rejected.
·4· · · · · · · · ··Now, I can't sit here and assess or guess
·5· · · ··at what that was that Dr. Rosenzweig was attesting
·6· · · ··to in that semi-annual inspection, so I guess I'm
·7· · · ··going to need some further clarification.··I
·8· · · ··apologize.
·9· ·Q· ··That's fine.··Mr. Rosenzweig will testify in this
10· · · ··matter as well.
11· · · · · · · · ··I'm trying to determine what information
12· · · ··that you have as it relates to this because you've
13· · · ··testified that the two Viridis laboratories were
14· · · ··not complying with their standard operating
15· · · ··procedure, and the way it appears from testimony so
16· · · ··far is that you received that in November 2020 and
17· · · ··their semi-annual inspection in December 2020 but
18· · · ··they're approved.
19· ·A· ··No.··So we actually don't approve methods in our
20· · · ··semi-annual inspections.··So I want to be clear
21· · · ··there.··So we actually approve our methods on our
22· · · ··method validation reviews and our Method Approval
23· · · ··Reports.··So, again, those are very separate
24· · · ··processes.··And I can't speak to what
25· · · ··Dr. Rosenzweig wrote in there.··Again, I didn't

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·1· · · ··write that.
·2· · · · · · · · ··But the December method that it was
·3· · · ··performed at that point in time is not the same as
·4· · · ··the method that was on the record for the
·5· · · ··laboratories.
·6· ·Q· ··So does Dr. Rosenzweig have the authority to pass a
·7· · · ··laboratory and semi-annual inspection?
·8· ·A· ··Yes, he does.··Absolutely.
·9· ·Q· ··And Dr. Rosenzweig would have known at that time
10· · · ··what SOP the CRA was claiming was the approved SOP;
11· · · ··correct?
12· ·A· ··Well, yes, we maintain a copy of the approved SOP
13· · · ··on file.··I would say that Dr. Rosenzweig would
14· · · ··have access to that, therefore he -- he could have
15· · · ··that information accessible to him, yes, sir.
16· ·Q· ··And I believe you just testified that at the
17· · · ··semi-annual inspection or in the report you don't
18· · · ··approve methods in that way, that you have a
19· · · ··procedure for doing so, that you send out Method
20· · · ··Approval Reports; correct?
21· ·A· ··Yes, sir.
22· ·Q· ··Okay.··But you testified earlier this morning that
23· · · ··the May 2020, there wasn't a Method Approval Report
24· · · ··that was ever sent out for that; correct?
25· ·A· ··Yes, sir, I want to clarify again.··For substantive

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·1· · · ··changes we use the Method Approval Report.··For the
·2· · · ··clarification of the term homogenization to ensure
·3· · · ··consistency between technicians, that was not
·4· · · ··necessary for us to include an additional Method
·5· · · ··Approval Report because that's a very simple
·6· · · ··clarification for staff.
·7· ·Q· ··So the answer to the question is that it's correct
·8· · · ··that you didn't send out a Method Approval Report
·9· · · ··in May of 2020?
10· ·A· ··Yes, because it wasn't required.
11· ·Q· ··But you're talking about your internal procedures;
12· · · ··correct?
13· ·A· ··Yes, sir.
14· ·Q· ··Okay.
15· ·A· ··And those would have been -- internal procedures
16· · · ··are not procedures that Viridis Laboratories or
17· · · ··Viridis North would have been aware of.··I would
18· · · ··assume that they're not aware of the internal
19· · · ··procedures of their regulatory agency.
20· ·Q· ··So I just want to show you what's been marked as
21· · · ··Exhibit 6.
22· ·A· ··Would you mind zooming in on that, please?··Thank
23· · · ··you so much.
24· · · · · · · · ··MR. RUSSELL:··Can you scroll through it?
25· · · · · · · · ··THE WITNESS:··Is that dated January 24th?

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·1· · · ··I'm so sorry.··Thank you.
·2· ·Q· ··(MR. RUSSELL) Do you recognize this document?
·3· · · · · · · · ··I'm sorry --
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, is Exhibit 6
·5· · · ··under a different -- one of the dep transcripts by
·6· · · ··chance?··Because I don't see it in the list.
·7· · · · · · · · ··MR. SCHUMACHER:··Yeah.··It's Exhibit 6.
·8· · · · · · · · ··MR. RUSSELL:··It's Exhibit 6, Your Honor.
·9· · · · · · · · ··MR. SCHUMACHER:··Rosenzweig dep.
10· · · · · · · · ··JUDGE GOLDSTEIN:··Oh, Rosenzweig dep
11· · · ··exhibits?
12· · · · · · · · ··MR. RUSSELL:··No, it's just in the --
13· · · ··this is 6 I believe.
14· · · · · · · · ··JUDGE GOLDSTEIN:··No, there's no 6
15· · · ··listed.··That's what I'm talking about.
16· · · · · · · · ··MR. SCHUMACHER:··From the Rosenzweig dep.
17· · · · · · · · ··MR. RUSSELL:··Which one?
18· · · · · · · · ··JUDGE GOLDSTEIN:··But is that January
19· · · ··24th, 2021, semi-annual inspection?
20· · · · · · · · ··MR. RUSSELL:··It's the, yes, response for
21· · · ··Viridis Laboratories.··I'm getting you the number.
23· · · · · · · · ··JUDGE GOLDSTEIN:··That's not Number 6
24· · · ··under the Rosenzweig dep exhibits.
25· · · · · · · · ··MR. RUSSELL:··It's Number 7, Your Honor.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Number 7?··I don't have
·2· · · ··that either.
·3· · · · · · · · ··MR. RUSSELL:··I believe that was sent to
·4· · · ··Your Honor.··I mean, I guess to the extent it's not
·5· · · ··necessary that this gets admitted in if you're --
·6· · · ··if the Tribunal has an issue with this.··This was,
·7· · · ··I believe, signed.··I can double-check on that.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··What's --
·9· · · · · · · · ··MR. RUSSELL:··We have Bates stamped this
10· · · ··and -- I'm sorry?
11· · · · · · · · ··JUDGE GOLDSTEIN:··What's the original
12· · · ··exhibit you marked it as?
13· · · · · · · · ··MR. RUSSELL:··6, Your Honor.
14· · · · · · · · ··JUDGE GOLDSTEIN:··6.··And it was under
15· · · ··the regular -- the main list or one of the dep
16· · · ··exhibit -- or dep exhibits --
17· · · · · · · · ··MR. RUSSELL:··It was under the main list,
18· · · ··Your Honor.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Well, I don't have it.
20· · · ··So if you ask for it to be admitted I'll ask you to
21· · · ··just submit it after the hearing.··Okay?
22· · · · · · · · ··MR. RUSSELL:··Yeah, I would ask that it
23· · · ··be admitted, Your Honor.··And we can provide it
24· · · ··again after the hearing.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So you're moving

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·1· · · ··at this time for Viridis Exhibit 6?
·2· · · · · · · · ··MR. RUSSELL:··And I guess if there's no
·3· · · ··objection.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Any objection?
·5· · · · · · · · ··MS. HUYSER:··I wasn't sure.··Did you get
·6· · · ··a chance to have Ms. Patterson look all through
·7· · · ··that?··I don't believe -- I don't know if I saw all
·8· · · ··the way down to the bottom.··Sorry.
·9· · · · · · · · ··THE WITNESS:··No, I have not either.
11· ·Q· ··(MR. RUSSELL) Ms. Patterson, do you recognize that
12· · · ··document?
13· ·A· ··I can't say that I recognize this document in
14· · · ··particular, but it appears to be a response from
15· · · ··Viridis Laboratories regarding the December 22nd,
16· · · ··2020, Semi-Annual Inspection Report.
17· ·Q· ··And would this be a type of document that you would
18· · · ··expect to receive from Viridis in response to a
19· · · ··semi-annual inspection?
20· ·A· ··Yes, sir.
21· · · · · · · · ··MR. RUSSELL:··Okay, Your Honor, I would
22· · · ··ask to move this into evidence as Exhibit 6.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Any objection?
24· · · · · · · · ··MS. HUYSER:··I would object at this point
25· · · ··in time just because I don't believe that

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·1· · · ··Ms. Patterson had said she has ever seen this.
·2· · · · · · · · ··Obviously, as Mr. Russell pointed out,
·3· · · ··Dr. Rosenzweig will be testifying later, and he may
·4· · · ··be the better person to admit that to if this is
·5· · · ··addressed -- admit that with if it was addressed to
·6· · · ··him.
·8· · · · · · · · ··MR. RUSSELL:··Well, Your Honor, I think
·9· · · ··this is a document that's kept in the normal course
10· · · ··of business.··And I recognize the fact that
11· · · ··Ms. Patterson has indicated that she doesn't
12· · · ··necessarily recollect this document, but she has
13· · · ··testified that this would be a document that would
14· · · ··be in response to the semi-annual inspection that
15· · · ··she received.
16· · · · · · · · ··And I believe that if you look at the
17· · · ··response under Number 12 on page 5 or 6 of 9 it
18· · · ··specifically matches up with the Semi-Annual
19· · · ··Inspection Report that was just admitted into
20· · · ··evidence.
21· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··I will
22· · · ··admit Viridis Exhibit 6.
24· · · · · · · · ··JUDGE GOLDSTEIN:··And please submit that
25· · · ··afterwards.··I see it listed on your exhibit list,

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·1· · · ··but I'm not sure -- maybe it's just mismarked on
·2· · · ··the exhibits you sent, I just can't be sure.
·3· · · · · · · · ··MR. RUSSELL:··All right.··Thank you, Your
·4· · · ··Honor.
·5· · · · · · · · ··If you can go to 12.··Page 6 I think.
·6· ·Q· ··(MR. RUSSELL) So inside this document I believe
·7· · · ··this 12 corresponds with 12 inside of the
·8· · · ··semi-annual inspection which we just looked at.
·9· · · ··And if you look under the inspector's comments I
10· · · ··believe that first two sentences also correlate
11· · · ··with exactly what's in the semi-annual inspection.
12· · · ··Would you agree?
13· ·A· ··Yes, sir, I agree.
14· ·Q· ··Okay.··And so -- and there's two bullet points that
15· · · ··I don't believe, or at least I don't recall seeing
16· · · ··in the semi-annual inspection that are listed
17· · · ··there, and the first one, I'll just read it.··"The
18· · · ··testing staff were told to prep for potency
19· · · ··following their SOP which was not approved by the
20· · · ··MRA.··The changes to the SOP were not validated nor
21· · · ··proven to be analytically sound."
23· ·A· ··You did.··And I don't mean to be argumentative,
24· · · ··sir, but I do believe I saw those in the
25· · · ··Semi-Annual Inspection Report.··I would have to go

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·1· · · ··back --
·2· ·Q· ··Okay.
·3· ·A· ··-- before I confirm that.
·4· ·Q· ··And they may have been.··I'm not disputing that.
·5· · · · · · · · ··And in the second bullet point it says
·6· · · ··"Please provide an updated potency SOP validations
·7· · · ··and passing PT for approval from the MRA"; correct?
·8· ·A· ··Yes, sir.
·9· ·Q· ··Okay.··And then below that in the response is the
10· · · ··response that I read earlier that was also in the
11· · · ··semi-annual inspection; correct?
12· ·A· ··I'm not exactly sure if it was the same response.
13· · · ··I believe that this response here, and maybe that's
14· · · ··where some of the confusion was earlier, I believe
15· · · ··this response is actually from Viridis themselves.
16· · · ··Is that correct?
17· ·Q· ··Correct.··Yes.
18· ·A· ··Oh, okay.··Thank you for clarifying.
19· · · · · · · · ··Yes, this response is from Viridis.··That
20· · · ··makes sense.
21· ·Q· ··Right.··So my understanding of the procedure is
22· · · ··that a semi-annual inspection occurs, there's a
23· · · ··deficiency noted which was noted and it's in these
24· · · ··comments, and Viridis Laboratories and Viridis
25· · · ··North for every deficiency has ten days in which to

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·1· · · ··file a response.··Is that right?
·2· ·A· ··Yes, sir.··And I believe this is outside of that
·3· · · ··ten-day time line.··But yes, you are correct on
·4· · · ··that procedure.
·5· ·Q· ··And so the -- the response would be incorporated
·6· · · ··into the semi-annual inspection; correct?
·7· ·A· ··Yes, typically that is the case.
·8· ·Q· ··Okay.··Which we saw that this was.··I mean, this
·9· · · ··response stated again, it states "The procedure has
10· · · ··not changed.··Staff training and standardization of
11· · · ··sampling and handling were conducted to improve
12· · · ··consistency between laboratories in 2020.
13· · · ··Additional sample handling details were added to
14· · · ··the procedure at the request of the MRA and sent to
15· · · ··them on December 3rd."
17· ·A· ··Yes, you absolutely did.··And I appreciate that
18· · · ··clarification as to the fact that that came from
19· · · ··Viridis.
20· · · · · · · · ··MR. RUSSELL:··Okay.··You can take that
21· · · ··down.
22· ·Q· ··(MR. RUSSELL) So at this point you had the email
23· · · ··chain, you received the updated SOP, and now both
24· · · ··of the laboratories have passed their semi-annual
25· · · ··inspection; correct?

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·2· ·Q· ··Okay.··And at this point nobody from Viridis
·3· · · ··Laboratories or Viridis North has been notified
·4· · · ··that there's any issue with their potency method
·5· · · ··outside of the deficiency that was responded to;
·6· · · ··correct?
·7· ·A· ··Oh, no, that is not correct, sir.··As I believe you
·8· · · ··showed me in at least some of the email chains and
·9· · · ··some of the email chains that Ms. Huyser showed me
10· · · ··yesterday there were communications via email back
11· · · ··and forth where I noted very clearly to the
12· · · ··laboratory that I had significant concerns about
13· · · ··the sample preparation and homogenization steps of
14· · · ··their methods.··And I believe I even used the term
15· · · ··that I would look into it further or potentially
16· · · ··investigate further.··I requested that the
17· · · ··laboratory perform internal audits to figure out
18· · · ··exactly what was going on and why these deviations
19· · · ··were occurring.
20· · · · · · · · ··So absolutely at this point they should
21· · · ··have been fully aware that we had concerns about
22· · · ··this method completely outside of the semi-annual
23· · · ··inspection process.
24· ·Q· ··So you've agreed that you never sent a rejection
25· · · ··for the SOP that was sent on December 3rd.··You

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·1· · · ··testified to that?
·2· ·A· ··Yes, sir, because it was not submitted to us with
·3· · · ··the appropriate materials that were required for an
·4· · · ··SOP update of that nature.
·5· ·Q· ··And then fast-forward December 22nd, 2020, both of
·6· · · ··the laboratories passed their semi-annual
·7· · · ··inspection; correct?
·8· ·A· ··Yes, sir, that is correct, because those are
·9· · · ··unrelated items.
10· ·Q· ··Because -- you're claiming because it wasn't on
11· · · ··some form that would be necessary for an SOP to be
12· · · ··approved; correct?
13· ·A· ··Yes, sir, because they look for two very different
14· · · ··things.··As I stated previously, we have a pathway
15· · · ··for the approval of standard operating procedures,
16· · · ··validations, verifications that require the
17· · · ··submission of data.··It wouldn't make sense to be
18· · · ··able to do that in the semi-annual inspection
19· · · ··procedure and pathway because those are two very
20· · · ··separate things.··One is looking specifically at
21· · · ··compliance with a broad set of rules put forth in a
22· · · ··checklist, and I would say that's more of a
23· · · ··big-picture analysis of the laboratory operations,
24· · · ··whereas when you're submitting a method that's a
25· · · ··very granular, detailed process that certainly

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·1· · · ··requires a process of its own.
·2· ·Q· ··You testified earlier that your job is to protect
·3· · · ··public health and safety; correct?
·4· ·A· ··Yes, sir.··Absolutely.
·5· ·Q· ··So at this point you received the SOP.··You know
·6· · · ··that the two labs are using the SOP.··You've
·7· · · ··approved -- they've passed their semi-annual
·8· · · ··inspection.··And at this point you've done nothing
·9· · · ··or said nothing to either of the two laboratories
10· · · ··to tell them that they shouldn't be using this SOP?
11· ·A· ··No, sir, that's not true.··I think I just said that
12· · · ··we had numerous email communications where I told
13· · · ··them that I had questions about this SOP and I was
14· · · ··trying to learn more information because, to be
15· · · ··frank with you, I felt that the licensee was
16· · · ··withholding critical information from me.
17· · · · · · · · ··So instead of jumping on them and, you
18· · · ··know, trying to go down some sort of negative road
19· · · ··I was trying to learn more information to help
20· · · ··myself and them understand where the necessary
21· · · ··deviations were occurring here.
22· ·Q· ··So the conversations that you're talking about are
23· · · ··the emails from November till December 3rd?
24· ·A· ··I would say November ongoing for a long period of
25· · · ··time.··But if you want to cap it at December 3rd

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·1· · · ··right here, yes, that's fair.
·2· ·Q· ··Okay.··And so then -- which I believe that is
·3· · · ··correct, I can go back and look at it, but -- and
·4· · · ··then you fast-forwarded it to December 22nd, and
·5· · · ··that's the next -- next time that there's any
·6· · · ··discussion about it, and that's when the method is
·7· · · ··actually reviewed that your LSS actually watches
·8· · · ··both laboratories conduct their potency method;
·9· · · ··correct?
10· ·A· ··Yes, sir, that is correct.··I would say there is,
11· · · ··you know, maybe a few weeks of time in between
12· · · ··then.··There would be no need for us to badger a
13· · · ··licensee to find out more information if we were
14· · · ··already going to find out this information at a
15· · · ··previously scheduled semi-annual inspection.··It
16· · · ··seems prudent to save everyone time in that matter.
17· ·Q· ··So if you thought that the -- they weren't
18· · · ··complying with the administrative rules then they
19· · · ··would have failed that inspection?
20· ·A· ··Again, that's not how the semi-annual inspection
21· · · ··checklists are written.··And I think I testified to
22· · · ··the fact yesterday that the administrative rules at
23· · · ··that time were not perfect.··And, to be frank, it
24· · · ··was an oversight in the semi-annual inspection
25· · · ··process.

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·1· · · · · · · · ··So it was necessary for us to actually be
·2· · · ··able to audit that method, visualize what was
·3· · · ··really happening in the laboratory space so that we
·4· · · ··could have a better understanding and better
·5· · · ··indication of what the laboratory was really doing
·6· · · ··in practice.
·7· · · · · · · · ··Again, this was at the height of the
·8· · · ··COVID-19 pandemic.··Typically we would go ahead and
·9· · · ··go on site to a laboratory to view something like
10· · · ··this.··But I also want to remind you it is a rule
11· · · ··for a licensee to use SOPs that have been approved
12· · · ··by the Agency.
13· · · · · · · · ··And I want to reiterate this
14· · · ··November-December method had never received
15· · · ··approval from the Agency.··But we can't make that
16· · · ··allegation until we're able to actually visualize
17· · · ··what the technicians are doing in that space.
18· ·Q· ··Right, which you did on December 22nd, 2020, when
19· · · ··you actually viewed them do that and then you
20· · · ··passed them approving what they were doing?
21· ·A· ··No, sir, it's not that we were approving that
22· · · ··method, we approved them through the semi-annual
23· · · ··inspection checklist.··And, again, I want to
24· · · ··reiterate that doesn't cover all of the

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·1· · · · · · · · ··So what that semi-annual inspection gave
·2· · · ··us was, one, a passing Semi-Annual Inspection
·3· · · ··Report; however, there were deviations from the
·4· · · ··administrative rules that were not captured in that
·5· · · ··semi-annual inspection checklist.··And that was the
·6· · · ··deviation that Noah noted in the inspection itself.
·7· · · ··The licensee was informed at that time that that
·8· · · ··rule deviation occurred.··They were using a method
·9· · · ··that was not approved by the Agency.··And that,
10· · · ··that evidence collected there on that day went on
11· · · ··to start an investigation because of the rule
12· · · ··violation that was identified.
13· ·Q· ··And we'll get into that in a minute.··But you
14· · · ··testified because of the way the administrative
15· · · ··rules were written they had to pass the semi-annual
16· · · ··inspection, but yet you really can't point to any
17· · · ··rule that states that, can you?
18· ·A· ··Well, that's also not what I said, sir.
19· ·Q· ··Okay.··Well, let me know what you said that I
20· · · ··misunderstood.
21· ·A· ··Well, you just said that I said that the rules said
22· · · ··that they have to pass their semi-annual
23· · · ··inspection.
24· ·Q· ··I believe your testimony was if they have an
25· · · ··approved SOP on file then they have -- you have to

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·1· · · ··pass the semi-annual inspection.··It doesn't matter
·2· · · ··if they're not complying with it.
·3· ·A· ··No, no.··It's not if they have an approved SOP on
·4· · · ··file they have to pass the semi-annual inspection.
·5· · · ··There's still a myriad of ways that they could fail
·6· · · ··a semi-annual inspection.
·7· · · · · · · · ··As the rule was written in particular
·8· · · ··related to a semi-annual -- or related to an
·9· · · ··approved SOP or an SOP on file I believe the word
10· · · ··used in the rule at that time was "maintain,"
11· · · ··meaning they simply had to have an approved method
12· · · ··on file.··And they did.··They had the May 2020
13· · · ··method on file.
14· ·Q· ··Well, and then in addition to that the rules would
15· · · ··require a licensee to follow an approved SOP;
16· · · ··correct?
17· ·A· ··To -- I'm not sure if it was to follow an approved
18· · · ··SOP, but it may not have been something that was
19· · · ··captured in that semi-annual inspection checklist.
20· ·Q· ··That the SOP that you claim was operative wasn't
21· · · ··being followed?··I think it's exactly what was set
22· · · ··forth by Mr. Rosenzweig.
23· ·A· ··That may be the case.··But if they had failed that
24· · · ··and it was on the semi-annual inspection checklist
25· · · ··then they would have failed the semi-annual

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·1· · · ··inspection.
·2· ·Q· ··So are your checklists referenced in any
·3· · · ··administrative rules?
·4· ·A· ··I believe just loosely as inspections potentially.
·5· · · ··To be honest, I don't know.
·6· ·Q· ··So this checklist that you're talking about that
·7· · · ··you have to comply with in order for making a
·8· · · ··determination if someone passed or failed, that's
·9· · · ··not actually any rule anywhere --
10· ·A· ··Oh, that's --
11· ·Q· ··-- that's something that --
12· ·A· ··If -- I apologize, Mr. Russell.··Go ahead.
13· ·Q· ··Go ahead.··Go ahead.
14· ·A· ··It is a collection of a subset of the
15· · · ··administrative rules that have been combined
16· · · ··together in a single document.··And that document
17· · · ··is accepted at the current time under those current
18· · · ··administrative rules as the semi-annual inspection
19· · · ··checklist.
20· · · · · · · · ··And, again, I want to reiterate that a
21· · · ··licensee is subject to follow all applicable
22· · · ··statutory and rule requirements despite the fact
23· · · ··that they may not be in that semi-annual inspection
24· · · ··checklist itself.
25· ·Q· ··So even assuming your testimony is accurate you

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·1· · · ··could issue a cease and desist letter at any time
·2· · · ··to one of the laboratories; correct?
·3· ·A· ··I could not issue a cease and desist letter to a
·4· · · ··laboratory at any time.··I believe there are pretty
·5· · · ··significant parameters to doing so.
·6· ·Q· ··There is a mechanism to summarily suspend a
·7· · · ··license; is that correct?
·9· ·Q· ··Okay.··So would you agree if you believe that a
10· · · ··laboratory was failing to comply with an approved
11· · · ··SOP that the CRA has the ability to summarily
12· · · ··suspend a license?
13· ·A· ··Absolutely.
14· ·Q· ··And if you thought that a laboratory was producing
15· · · ··results that had a negative effect on public health
16· · · ··and safety presumably you would issue a summary
17· · · ··suspension; correct?
18· ·A· ··Unfortunately, I would not issue a summary
19· · · ··suspension.··That would be something that would be,
20· · · ··honestly, up to the decision of the directors, the
21· · · ··operations director.··To be honest, I'm not sure
22· · · ··who above me makes those decisions, but it's not
23· · · ··me.
24· ·Q· ··I'm going to show you what's been marked as Exhibit
25· · · ··9.

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·1· ·A· ··Thank you.
·2· ·Q· ··I'm going to scroll through this document.··Tell me
·3· · · ··if you know what this is.
·4· ·A· ··This is a Method Approval Report.··I assume it was
·5· · · ··for Viridis.··Yes, sir.
·6· ·Q· ··Do you recognize this document?
·8· ·Q· ··Okay.
·9· ·A· ··Can you --
10· ·Q· ··Is this --
11· ·A· ··-- scroll up to the top?
12· ·Q· ··Sorry.··Sure.
13· ·A· ··No, you're fine.··Thank you.
14· · · · · · · · ··Okay.··Thank you.
15· ·Q· ··Do you recognize the document?
16· ·A· ··Yes, I do.
17· ·Q· ··Okay.··And is this a document that is prepared by
18· · · ··someone at the CRA?
19· ·A· ··Yes, sir, it is.
20· ·Q· ··Okay.··And is this an accurate depiction of the
21· · · ··Method Approval Report?
23· · · · · · · · ··MR. RUSSELL:··Your Honor, I would move to
24· · · ··admit this into evidence as Exhibit 7.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, any objection?

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·1· · · ··You're on mute.
·6· ·Q· ··(MR. RUSSELL) First of all, can you tell us what
·7· · · ··the actual document is, the purpose of the
·8· · · ··document?
·9· ·A· ··Absolutely.··So the Method Approval Report is, as I
10· · · ··said yesterday, essentially a living document of
11· · · ··all the collections of methods that a laboratory
12· · · ··has been approved over time, any significant
13· · · ··updates that we've gotten or any responses back
14· · · ··essentially to help the laboratory and their
15· · · ··representatives keep track of where a method is in
16· · · ··its statuses with the Agency.
17· ·Q· ··And I believe you testified yesterday and I think
18· · · ··you were referring to this document, it is a living
19· · · ··document that you -- you continue to update.··Is
21· ·A· ··Yes, it does continue to be updated over time.
22· ·Q· ··Okay.··So I want to show you -- well, first of all,
23· · · ··it appears in the document that all the different
24· · · ··matrices are noted.··Would that be correct?
25· ·A· ··Yes, in this one it says it's approved for all

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·1· · · ··analyses listed below on all matrices which include
·2· · · ··flower, infused, and concentrate products.
·3· ·Q· ··Okay.··So I want to look at potency which is on
·4· · · ··page 2 of 10 --
·5· ·A· ··Okay.
·6· ·Q· ··-- specifically.··Okay?
·7· · · · · · · · ··So this potency over -- under Number 1,
·8· · · ··and then it lists it appears to be some PT results
·9· · · ··which are -- well, what are PT results?
10· ·A· ··Proficiency test results.··And those would be for
11· · · ··external proficiency tests provided by some sort of
12· · · ··third-party vendor.
13· ·Q· ··Okay.··And then there are some -- like some
14· · · ··comments looks like 4/16/2020 under small i,
15· · · ··"Method submitted, accepted on 1/24/20 for analysis
16· · · ··as written on flower matrix only," and then small 2
17· · · ··"Passing proficiency tests submitted to the Agency
18· · · ··on 4/2/2020.··Method approved for analysis of
19· · · ··concentrates."
20· · · · · · · · ··Did I read that right?
21· ·A· ··I'm so sorry, I'm not seeing the --
22· ·Q· ··Okay.
23· ·A· ··-- 4/2 dates.
24· ·Q· ··Yeah, sorry.··There you go.
25· ·A· ··Oh.··Thank you so much.··Yes.

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·1· ·Q· ··Did I read that correctly?
·2· ·A· ··You'll have to repeat it again, I'm sorry.
·3· ·Q· ··Well, I'm looking at i and 2 under the comments
·4· · · ··there.··It appears that the method submitted and
·5· · · ··accepted on January 24th, 2020, for analysis is
·6· · · ··written on flower matrix only.
·7· · · · · · · · ··So there was a method approved on that
·8· · · ··date; is that correct?
·9· ·A· ··Yes, sir.
10· ·Q· ··Okay.··And then it goes on to talk about in the
11· · · ··next two passing proficiency tests submitted to the
12· · · ··Agency on 4/22/20; is that correct?
13· ·A· ··Yes, sir.
14· ·Q· ··Okay.··And then underneath that it states "Updates
15· · · ··submitted on July 8th, 2020."
17· ·A· ··Yes, sir.
18· ·Q· ··Okay.··What I don't see here is anything related to
19· · · ··the May 2020 SOP.··Am I missing that?
20· ·A· ··No, sir, you're not.··Again, no substantive changes
21· · · ··were made during the May SOP.··The word homogenize
22· · · ··was simply clarified for staff in order to be able
23· · · ··to perform that consistently between the
24· · · ··technicians.
25· ·Q· ··And then it indicates "Updates submitted on July

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·1· · · ··8th, 2020.··Potency approved on all matrices."
·2· · · ··Correct?
·3· ·A· ··Yes, sir.
·4· ·Q· ··Okay.··And there's no deficiencies noted.··Am I
·5· · · ··right about that?
·6· ·A· ··That is correct, I see no deficiencies noted there.
·7· ·Q· ··Okay.··So I believe the date of this is February
·8· · · ··5th, 2021.··Am I correct about that?
·9· ·A· ··You'd have to go up so I could verify, but I
10· · · ··believe you.··Yes, sir.
11· ·Q· ··Okay.··And so this would be a document that would
12· · · ··have been sent out for Viridis Lansing; correct?
13· ·A· ··Yes, this was sent to Viridis Lansing as it related
14· · · ··specifically -- if you look up in the method name
15· · · ··and SOP number this would have been sent to them in
16· · · ··response to LOM 7.17, total yeast and mold plating
17· · · ··and count.
18· · · · · · · · ··So I think an important clarification to
19· · · ··make here is that when we send this Method Approval
20· · · ··Report we actually only update whatever it is that
21· · · ··the method was that got added.
22· · · · · · · · ··So in this case the method that got added
23· · · ··was LOM 7.17, total yeast and mold plating and
24· · · ··count.··This had nothing to do with potency.
25· ·Q· ··So it's your testimony that these Method --

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·1· · · · · · · · ··MR. RUSSELL:··You can take it down.
·2· ·Q· ··(MR. RUSSELL) It's your testimony that the Method
·3· · · ··Approval Reports only reference updates to whatever
·4· · · ··the method is that's being approved; is that right?
·5· ·A· ··That's being submitted at that time, yes.··If there
·6· · · ··were multiple methods, they would be listed on
·7· · · ··there.
·8· ·Q· ··Okay.··So I'm going to show you what's been marked
·9· · · ··as Exhibit 15, if you can look at this document.
10· · · ··And I'll have Lorri scroll through it to make sure
11· · · ··that you understand what this is.
12· ·A· ··Thank you very much.
13· · · · · · · · ··Would you mind going back up to the top
14· · · ··again for me?
15· · · · · · · · ··Again, Mr. Russell, this is a Method
16· · · ··Approval Report.
17· ·Q· ··Okay.··And is this an accurate depiction of a
18· · · ··Method Approval Report for Viridis Lansing, review
19· · · ··date 4/28/2021?
20· ·A· ··Yes, it is.
21· · · · · · · · ··MR. RUSSELL:··Okay.··I would ask that
22· · · ··this be admitted as Exhibit 8, Your Honor.
24· · · · · · · · ··JUDGE GOLDSTEIN:··Viridis Exhibit 8 is

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·2· ·Q· ··(MR. RUSSELL) So first I want to look at the
·3· · · ··previous exhibit which I think is the same type of
·4· · · ··form you have indicated that the method name is
·5· · · ··stated in the right top of that box.··Am I correct?
·7· ·Q· ··And in this one it says "plating and count"; is
·8· · · ··that right?
·9· ·A· ··Yes, sir, just as the last one did.
10· ·Q· ··Okay.··So I think you testified, then, that -- and
11· · · ··this would only relate to the plating and count; is
12· · · ··that right?
14· ·Q· ··Okay.··So I want to go down to page 2 of 10.
15· · · ··Again, I believe this is the same information as it
16· · · ··relates to the potency.··And it says "Potency
17· · · ··approved on all matrices"; is that correct?
18· ·A· ··Yes.··I don't see any updates that are related to
19· · · ··this date so this would have been all old
21· ·Q· ··So if there isn't some kind of deficiency that's
22· · · ··noted on one of the other matrices it wouldn't be
23· · · ··included in this document; correct?
24· · · · · · · · ··MR. RUSSELL:··Can you go down to page 5?
25· ·Q· ··(MR. RUSSELL) So this is under the metals analysis,

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·1· · · ··and then it states -- can you go down to the
·2· · · ··yellow?··You see there where it says "Updates
·3· · · ··submitted 4/28/2021," and then "The current method
·4· · · ··does not meet the SMPR requirements for the
·5· · · ··following analytes and will need to be updated.
·6· · · ··Copper before August 11, 2021."
·7· · · · · · · · ··Did I read that right?
·8· ·A· ··Yes, sir, you did.
·9· ·Q· ··Okay.··So I think you described this as a living
10· · · ··document.··And it appears that in this document
11· · · ··you're noting a deficiency for metals; is that
12· · · ··correct?
13· ·A· ··I don't believe that this is necessarily a
14· · · ··deficiency and I also don't think I was the person
15· · · ··that issued this.··But based on the information I'm
16· · · ··seeing here, I think this is a notification to the
17· · · ··licensee that there was an SMPR, which is a
18· · · ··standard method of performance requirement that was
19· · · ··published, and it was a notification to them that
20· · · ··the current method did not meet those SMPR
21· · · ··requirements.··That is what it seems to say at
22· · · ··least.
23· ·Q· ··So this is -- this is for total yeast and mold,
24· · · ··correct?··That's what the purpose of this method
25· · · ··approval form is?

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·1· ·A· ··That is what it's labeled as yes, sir.
·2· ·Q· ··So then why is there a deficiency or an update
·3· · · ··noted for -- for metals and residual solvents and
·4· · · ··also microbial analysis when I believe you just
·5· · · ··testified that these -- these Method Approval
·6· · · ··Reports were only related to the -- the testing
·7· · · ··that was set forth in the upper right-hand corner
·8· · · ··box of the Method Approval Report?
·9· ·A· ··First, I can't speak to that.··I've not seen the
10· · · ··residual solvents or the microbial portion in
11· · · ··detail to be able to testify to that.
12· · · ··Additionally, I can't testify to that because I
13· · · ··didn't publish this report.
14· ·Q· ··Okay.··Well, you just did testify a minute ago to
15· · · ··the fact that these are specific to whatever is
16· · · ··being approved, and that for potency there wouldn't
17· · · ··be any updates because it didn't relate to potency,
18· · · ··but yet if you go down -- so we've looked at the
19· · · ··metals.··Let's look at residual solvents on the
20· · · ··next page, if you go down to the bottom.
21· ·A· ··Thank you for going down to that, I appreciate it.
22· ·Q· ··Okay.··And would you agree with me that there's an
23· · · ··update that's submitted here, and it states that
24· · · ··the current method does not meet the SMPR
25· · · ··requirements for the following analytes, and then

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·1· · · ··it lists those that need to be updated?
·2· ·A· ··Yes, sir.
·3· ·Q· ··Okay.··And I'm -- am I wrong in the fact that
·4· · · ··that's not what -- that this was a -- this was not
·5· · · ··a method approval for metals or residual solvents?
·6· ·A· ··This is an update that was submitted.
·7· · · · · · · · ··To your point and I believe what you're
·8· · · ··getting at here is that there appears to be an
·9· · · ··administrative error in that top right corner.
10· · · ··Again, I can't --
11· ·Q· ··Actually, that's not -- actually, that's not what I
12· · · ··was getting at.
13· ·A· ··Okay.
14· ·Q· ··What I was getting at is that your living documents
15· · · ··actually do, regardless of the matrices that
16· · · ··they're related to, this living document does
17· · · ··include deficiencies and updates and requirements
18· · · ··for all the matrices.··And the potency is not --
19· · · ··there's nothing noted whatsoever on the potency on
20· · · ··either of the two that we've looked at so far.
21· · · · · · · · ··If we go down here even farther under
22· · · ··microbial analysis at the top of page 8 that too
23· · · ··has an update to it which I believe states that the
24· · · ··facility will not be able to use this method after
25· · · ··8/11/2021.

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·1· · · · · · · · ··So I believe at least three of the
·2· · · ··matrices on this report have deficiencies, updates
·3· · · ··providing information to the licensee to let them
·4· · · ··know there is some type of issue the CRA's letting
·5· · · ··you know you have until this date to do whatever it
·6· · · ··is the CRA's requiring.
·7· · · · · · · · ··Would you agree with me?
·8· ·A· ··Yes.··So these state that there were updates
·9· · · ··submitted.··Those updates were dated.··I can assume
10· · · ··that because they are included in this Method
11· · · ··Approval Report that these updates were submitted
12· · · ··with the appropriate documentation and through the
13· · · ··appropriate channels.··But yes, you're correct that
14· · · ··that is what that is stating.
15· ·Q· ··So it would be a fair assumption for a licensee to
16· · · ··believe when they receive this that there are no
17· · · ··deficiencies outstanding for potency when now
18· · · ··they've had two of these since the December 22nd,
19· · · ··2020, semi-annual inspection where there's been no
20· · · ··noted deficiencies from the CRA.··Am I right?
21· ·A· ··No, no, sir.··I disagree with that.
22· · · · · · · · ··Viridis is very familiar, and this
23· · · ··evidences it as well I believe, they're very
24· · · ··familiar with the process of how to submit methods
25· · · ··and updates to us for approval.··They know what

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·1· · · ··that process looks like.··And I think that this
·2· · · ··Method Approval Report really supports that as
·3· · · ··well.··They know how to submit these things to the
·4· · · ··Agency, what is required, what comes back to them.
·5· · · · · · · · ··So the fact that they were unable or
·6· · · ··unwilling to do that in the case of potency is
·7· · · ··still concerning to me.
·8· ·Q· ··Back to the May 2020 updated SOP, which I don't
·9· · · ··actually see that on here.··But there was never a
10· · · ··requirement there for anything to be submitted.
11· · · ··There wasn't a Method Approval Report that was
12· · · ··provided for from the CRA for that updated SOP;
13· · · ··correct?
14· ·A· ··Yes.··So to remind you again --
15· ·Q· ··You don't need to -- you don't need to remind me.
16· · · ··If you want to tell me why that is --
17· ·A· ··Sure.
18· ·Q· ··-- I'd be . . .
19· ·A· ··Yeah.··So the reason that that is is because it was
20· · · ··not a substantive change to the SOP, rather, it was
21· · · ··the result of an internal CAPA that was generated
22· · · ··by Viridis themselves noting that there was
23· · · ··disparity in the way that the technicians actually
24· · · ··interpreted the word homogeneous.··And that's very
25· · · ··different from choosing to add additional trichomes

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·1· · · ··back into a sample for a potency method.··That
·2· · · ··would be considered a substantive change with the
·3· · · ··knowledge that cannabinoids and thereby potency is
·4· · · ··contained within those trichomes.··That's going to
·5· · · ··give us significantly different outcomes to that
·6· · · ··standard operating procedure.
·7· · · · · · · · ··So, again, we do not require that a
·8· · · ··laboratory submits a validation for the definition
·9· · · ··of the word homogenization.
10· ·Q· ··I'm going to show you what's marked as -- what was
11· · · ··marked previously as Viridis Exhibit 21 but it's
12· · · ··now going to be Exhibit 9.
13· · · · · · · · ··Do you recognize that document?
14· ·A· ··Not this document in particular, but I can state
15· · · ··that it is a Method Approval Report issued by
16· · · ··Dr. Fields to I would anticipate Viridis North
17· · · ··Laboratories.
18· ·Q· ··And would you agree this is an accurate depiction
19· · · ··of that Method Approval Report?
20· ·A· ··Yes, sir.
21· · · · · · · · ··MR. RUSSELL:··Okay.··I'd move to have
22· · · ··this admitted as Exhibit 9.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Any objection, Counsel?

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·4· ·Q· ··(MR. RUSSELL) And moving down --
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Do you need a break at
·6· · · ··this point?
·7· · · · · · · · ··MR. RUSSELL:··I'm sorry?
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Do you need a break at
·9· · · ··this point?··We've been going over an hour.
10· · · · · · · · ··MR. RUSSELL:··Yeah, we can take a break,
12· · · · · · · · ··JUDGE GOLDSTEIN:··So we'll break until
13· · · ··2:35.··Okay?
15· · · · · · · · ··JUDGE GOLDSTEIN:··Off the record at 2:16.
16· · · · · · · · ··(Break taken at 2:16 PM)
18· · · · · · · · ··JUDGE GOLDSTEIN:··Back on the record in
19· · · ··the matter of Viridis Laboratories, LLC, and
20· · · ··Viridis North versus Cannabis Regulatory Agency,
21· · · ··consolidated Docket Numbers 21-029794, et al.··Time
22· · · ··is 2:36 PM.
23· · · · · · · · ··All right, Mr. Russell you may continue.
25· ·Q· ··(MR. RUSSELL) Ms. Patterson, we were going through

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·1· · · ··what has been marked as Exhibit 9 which is this
·2· · · ··Method Approval Report.
·3· · · · · · · · ··MR. RUSSELL:··She -- I didn't admit this.
·4· · · · · · · · ··MR. SCHUMACHER:··Yes.··Talking about this
·5· · · ··one.
·6· ·Q· ··(MR. RUSSELL) So I'm going to have you look through
·7· · · ··this, if you'd scroll through this and tell me if
·8· · · ··you know what this is.
·9· ·A· ··Absolutely.··Yes, sir, this is a Method Approval
10· · · ··Report issued by Dr. Fields to Viridis North
11· · · ··Laboratories on July 9th, 2021.
12· ·Q· ··And is this an accurate depiction of the Method
13· · · ··Approval Report?
15· · · · · · · · ··MR. RUSSELL:··Okay.··I would move, Your
16· · · ··Honor, to admit that into evidence as Exhibit 9.
21· ·Q· ··(MR. RUSSELL) So, Ms. Patterson, I believe that
22· · · ··this Method Approval Report is related to heavy
23· · · ··metal analysis.··Is that correct?
24· ·A· ··Yes, that is what the method name and SOP number
25· · · ··states.

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·1· ·Q· ··Okay.··And this appears to be for Viridis North
·2· · · ··Bay City; correct?
·3· ·A· ··Yes, sir.
·4· ·Q· ··And the review date would be July 9, 2021?
·5· ·A· ··Yes, sir.
·6· ·Q· ··Okay.··Looking down to the second page, I want to
·7· · · ··look at the potency again similar to what we did in
·8· · · ··the other Method Approval Reports it appears that
·9· · · ··this one on the potency while everything's approved
10· · · ··does include some additional information.··Would
11· · · ··you agree?
12· ·A· ··Yes, sir.
13· ·Q· ··Okay.··And I believe that the additional
14· · · ··information is it references updates submitted on
15· · · ··4/13/2020 satisfactorily addressed, method
16· · · ··approved.··Would you agree with that?
17· ·A· ··Yes, sir.
18· ·Q· ··Okay.··And then it again indicates that updates
19· · · ··were submitted on 7/1/2020; correct?
20· ·A· ··Yes, sir.
21· ·Q· ··And under that it states "Method updated to include
22· · · ··infused products and concentrates, approved";
23· · · ··correct?
24· ·A· ··Yes, sir.
25· ·Q· ··Okay.··Would you agree with me that these are new

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·1· · · ··entries as it relates to Method Approval Reports
·2· · · ··that we've been going through?
·3· ·A· ··They are different.··I believe the ones that we've
·4· · · ··been going through, correct me if I'm wrong, were
·5· · · ··Viridis Lansing and this is the Viridis North
·6· · · ··location.
·7· ·Q· ··Okay.··And there are no deficiencies noted.··Am I
·8· · · ··correct about that?
10· ·Q· ··Okay.··And if we go down to page 7, residual
11· · · ··solvents, it appears that there's some deficiency
12· · · ··noted for residual solvents; is that correct?
13· ·A· ··It was noted that updates were submitted on 4/28 of
14· · · ··2021, and then it continues to list those
15· · · ··deficiencies, yes, sir.
16· ·Q· ··Okay.··And it specifically notes that this method
17· · · ··will need to be -- will need to be updated;
18· · · ··correct?
19· ·A· ··Yes, sir.
20· ·Q· ··Or these SMPRs; is that correct?
21· ·A· ··Yes, sir, it states that they do not meet the SMPR
22· · · ··requirements that were published on 2/11/2021.
23· ·Q· ··And if you look down at the microbial analysis
24· · · ··under 7 it appears to note a deficiency from April
25· · · ··28, 2021, for microbials; correct?

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·1· ·A· ··Yep.··Updates were submitted 4/28/2021.··The SPMRs
·2· · · ··were not met.··Those were published on 2/11.··And
·3· · · ··then we note that they have six months to come into
·4· · · ··compliance with those standard method performance
·5· · · ··requirements.
·6· ·Q· ··Okay.··So, once again, in one of the other testing
·7· · · ··methods it appears that the CRA's providing
·8· · · ··information of what's deficient and what needs to
·9· · · ··be done.··Would you agree?
10· ·A· ··Yes.··And this is based on the licensee's
11· · · ··submission of their standard operating procedures
12· · · ··through the normal channels and again demonstrates
13· · · ··that they know how to submit methods through the
14· · · ··typical channels to receive review and approval.
15· ·Q· ··I'm going to show you what's marked as Exhibit --
16· · · ··or previously marked as Exhibit 22.··Do you
17· · · ··recognize this document?
18· ·A· ··Yes, sir.··This is a Method Approval Report.
19· ·Q· ··And do those accurately depict the Method Approval
20· · · ··Report that was produced by the CRA?
21· ·A· ··Yes, it does.
22· · · · · · · · ··MR. RUSSELL:··Your Honor, I move to admit
23· · · ··into evidence this Method Approval Report as
24· · · ··Exhibit 10.

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·4· ·Q· ··(MR. RUSSELL) Again, I want to go down under
·5· · · ··potency on page 2 and have you take a look at that
·6· · · ··and confirm for me that there are no deficiencies
·7· · · ··noted.
·8· ·A· ··Yes, sir.
·9· ·Q· ··Okay.··And if we go down to page 6 of 10, residual
10· · · ··solvents, it appears under the comments "Terpene
11· · · ··analysis added," and the bottom there that -- it
12· · · ··says "The method may be approved with the following
13· · · ··terpenes below when an acceptable PT is reported."
14· · · ··And then it goes on to say at the end in red "Not
15· · · ··accept"; is that correct?
17· ·Q· ··Okay.··So is this an indication that the CRA is not
18· · · ··approving a method?
19· ·A· ··It states that the method may be approved when the
20· · · ··PT is reported, that is correct.··I believe --
21· ·Q· ··Okay, so -- sorry.··Go ahead.
22· ·A· ··I believe that this was submitted with all other
23· · · ··relevant documentation aside from the proficiency
24· · · ··test.
25· · · · · · · · ··One important distinction here to note

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·1· · · ··though is that terpene analysis is not something we
·2· · · ··require on our required safety compliance tests for
·3· · · ··compliance tests for licensees.··And so we noted
·4· · · ··simply here that the PT was the only thing that was
·5· · · ··outstanding.
·6· ·Q· ··So you would agree with me, though, that the reason
·7· · · ··that this wasn't accepted was because Viridis
·8· · · ··Laboratories failed to provide you with this PT
·9· · · ··test that apparently is CRA policy they're required
10· · · ··to submit with their method approval?
11· ·A· ··Yes, sir.
12· ·Q· ··So there are times when not everything's submitted
13· · · ··to the CRA where the CRA will actually give a
14· · · ··response of whether a method's accepted or not
15· · · ··accepted; correct?
16· ·A· ··Only in the case of when a proficiency test is
17· · · ··missing that would indicate that the licensee has
18· · · ··submitted the SOP, the required validation
19· · · ··documents and data.··Again, all of the associated
20· · · ··logs, quality manual, all of that kind of
21· · · ··information that would be relevant to the SOP, yes,
22· · · ··sir.
23· ·Q· ··So there's a procedure in place where you'll
24· · · ··actually let the licensee know whether it's
25· · · ··accepted or not accepted if they only fail to

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·1· · · ··provide the CRA with a proficiency test?
·2· ·A· ··Yes, sir.
·3· ·Q· ··Okay.··That's part of some policy?
·4· ·A· ··Yes, sir.
·5· ·Q· ··And I'm going to show you what's previously been
·6· · · ··marked as Exhibit 31.··Do you recognize that
·7· · · ··document, Ms. Patterson?
·8· ·A· ··Yes, sir.··It is a Method Approval Report.
·9· ·Q· ··Okay.··And is this an accurate depiction of the
10· · · ··Method Approval Report for Viridis Lansing?
11· ·A· ··Yes, it is.
12· ·Q· ··Okay.··Let me direct your attention to page 2 of
13· · · ··15, the potency section.··It starts on 2 and goes
14· · · ··down through 3.
15· · · · · · · · ··Do you agree that there's no deficiencies
16· · · ··noted?
17· ·A· ··Yes, sir.··I believe this was submitted under
18· · · ··aspergillus methods.··I'd have to see where the
19· · · ··updates are located.
20· ·Q· ··Okay.··And under Number 6, which is the residual
21· · · ··solvents, that again shows a not accept or a PT
22· · · ··report was not submitted; correct?
23· ·A· ··I can't speak to whether or not it was submitted or
24· · · ··if it was out of range during an annual proficiency
25· · · ··test.

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·1· · · · · · · · ··Would you mind going up?··You're
·2· · · ··referring to the residual solvents?
·3· ·Q· ··Yes.
·4· ·A· ··Do you mean terpenoid analysis?
·5· ·Q· ··Yes.··I'm talking about under 7.7, I'm sorry, where
·6· · · ··it says "Not accept."
·7· ·A· ··Oh.··Thank you, sir.··Yes, that's the terpenoid
·8· · · ··analysis.··So yes, that does say "Not accept."
·9· · · ··Again, those are related to the proficiency tests
10· · · ··for nonrequired tests that the laboratory opts to
11· · · ··perform.
12· ·Q· ··While we're on this document I want to go down to
13· · · ··the microbial analysis starting on page 7 and going
14· · · ··down through page 12.··Can you tell me what these
15· · · ··represent?
16· ·A· ··These are external proficiency tests related to
17· · · ··microbials specifically it appears related to
18· · · ··salmonella, E. coli, and I believe aspergillus.
19· · · ··Yes, aspergillus.··I apologize.··It's a bit small.
20· ·Q· ··Okay.··And the dates on these, it says the analysis
21· · · ··date.··It appears to be July 19th, 2021.··Am I
22· · · ··correct about that?
23· ·A· ··I think it says 16, but maybe.··14, 16.
24· ·Q· ··You may be right.··My eyes are not good.··But would
25· · · ··you agree at least it's July 2021?

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·1· ·A· ··Yes, sir.
·2· ·Q· ··Okay.··Is it true that all these proficiency tests
·3· · · ··were passed?
·4· ·A· ··It does appear so.··The evaluation should say
·5· · · ··accept in order to indicate that they are passed.
·6· ·Q· ··So if we go up and we look at page 6 under PT
·7· · · ··results, is that what you're talking about?
·8· ·A· ··No.··I should clarify.··Those are older PT results
·9· · · ··that correspond with the date to the left of them.
10· · · ··The PT results that you were referring to should
11· · · ··say accept in those actual, like the tables that
12· · · ··were there that you were just showing me.
13· ·Q· ··Right.··And I believe going through those I see
14· · · ··that they're all accepted, and I just want to make
15· · · ··sure you heard me.
16· ·A· ··Yes, under that evaluation portion on the
17· · · ··right-hand side, the third column over.
18· ·Q· ··Okay.··So to be clear then, these microbial
19· · · ··proficiency tests then Viridis Lansing would have
20· · · ··passed all the proficiency tests for microbial
21· · · ··testing in July of 2021; is that correct?
23· · · · · · · · ··MR. RUSSELL:··You can take that down.
24· ·Q· ··(MR. RUSSELL) I want to show you what's been marked
25· · · ··as Exhibit 18C.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, let me
·2· · · ··interject.
·3· · · · · · · · ··MR. RUSSELL:··Yes.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··I'll mark this next one
·5· · · ··you were just talking about as Exhibit 11.
·6· · · · · · · · ··MR. RUSSELL:··Yes.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Were you planning on
·8· · · ··offering that?
·9· · · · · · · · ··MR. RUSSELL:··Yes.··And I apologize.
10· · · ··Thank you for the reminder.··I would move to admit
11· · · ··Exhibit 11 into evidence.
13· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Viridis
14· · · ··Exhibit 11 is admitted.··Thank you, Counsel.
15· · · · · · · · ··MR. RUSSELL:··Thank you for the reminder.
18· ·Q· ··(MR. RUSSELL) Do you recognize this document?
19· ·A· ··Yes, sir.··This is an inspection report issued 6/7
20· · · ··of '21 to Viridis Laboratories issued by Noah
21· · · ··Rosenzweig I would have to guess.··I believe that
22· · · ··was probably at the end of the document.
23· ·Q· ··I don't want you to guess.··Do you believe this is
24· · · ··an accurate representation of the inspection report
25· · · ··that was produced by Dr. Rosenzweig for this June

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·1· · · ··7, 2021, semi-annual inspection?
·3· · · · · · · · ··MR. RUSSELL:··Okay.··Your Honor, I would
·4· · · ··move to offer -- admit this into evidence as
·5· · · ··Exhibit 12.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··No objection?··Thank
·8· · · ··you, Ms. Huyser.
·9· · · · · · · · ··I'm not finding that one.··Was it
10· · · ··originally marked that?
11· · · · · · · · ··MR. RUSSELL:··It was marked as 18C.
12· · · · · · · · ··JUDGE GOLDSTEIN:··Is that under your
13· · · ··regular list or Rosenzweig exhibits?
14· · · · · · · · ··MR. RUSSELL:··No, it was regular list.
15· · · · · · · · ··JUDGE GOLDSTEIN:··I go from Exhibit 15 to
16· · · ··21.··No 18C.
17· · · · · · · · ··Did you say that you sent an updated list
18· · · ··last week?
19· · · · · · · · ··MR. RUSSELL:··We did, yes.··We put the
20· · · ··Bates stamps on it.
21· · · · · · · · ··Again, I'm happy to resend this.··I don't
22· · · ··think there's any objection -- I think Ms. Huyser
23· · · ··has indicated there's no objection to this
24· · · ··document.··We did -- you should have this document
25· · · ··though.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Well, if you would sent
·2· · · ··it with maybe your updated exhibits.··It might be
·3· · · ··in there but I'm not showing it, unless it's hidden
·4· · · ··among the deposition exhibits somewhere.
·5· · · · · · · · ··MR. RUSSELL:··Yeah, it's not part of
·6· · · ··that, Your Honor.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So Exhibit 12 --
·8· · · ··this is Exhibit 12?
·9· · · · · · · · ··MR. RUSSELL:··Correct.
10· · · · · · · · ··JUDGE GOLDSTEIN:··No objection?··All
11· · · ··right.··So you'll submit that after the hearing?
12· · · · · · · · ··MR. RUSSELL:··Yes.
13· · · · · · · · ··JUDGE GOLDSTEIN:··So Viridis Exhibit 12
16· ·Q· ··(MR. RUSSELL) Ms. Patterson, this other one, this
17· · · ··is a Semi-Annual Inspection for Viridis
18· · · ··Laboratories, LLC; correct?
19· ·A· ··Yes, sir.
20· ·Q· ··Okay.··So the Lansing laboratory?
21· ·A· ··Yes, sir.
22· ·Q· ··Okay.··And this seemed to be in a little bit
23· · · ··different form than what the December 2020
24· · · ··Semi-Annual Inspection Report was that we looked at
25· · · ··earlier.··Do you agree?

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·1· ·A· ··Yes, there was a form update that occurred between
·2· · · ··those two time periods I believe.
·3· ·Q· ··Okay.··And am I reading this correctly that no
·4· · · ··deficiencies were found?
·5· ·A· ··I apologize.··I don't see where you're seeing that.
·6· ·Q· ··So if you look under all the boxes --
·7· ·A· ··Yes, sir.
·8· ·Q· ··-- it says "An SCF semi-annual inspection was
·9· · · ··conducted on 6/7/21 at Viridis Laboratories, LLC.
10· · · ··No deficiencies were found."
11· ·A· ··Yes, sir, I see that.
12· ·Q· ··Okay.··So the June 7, 2021, semi-annual inspection
13· · · ··was passed, then, by Viridis Laboratories, LLC?
14· ·A· ··Yes, it was.
15· ·Q· ··Okay.··And is it true that Dr. Rosenzweig in
16· · · ··reviewing the -- doing the semi-annual inspection
17· · · ··in June of 2021 watched, again, the two
18· · · ··laboratories conduct a potency testing?
19· ·A· ··Yes, he did audit the potency testing method, and
20· · · ··this time it actually differed from what he
21· · · ··witnessed in December of 2020.
22· ·Q· ··Okay.··And it passed, though, at this inspection?
23· ·A· ··Well, the method did not pass.··The laboratory
24· · · ··passed the semi-annual inspection, though, you are
25· · · ··correct.

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·1· ·Q· ··Okay.··Well, was there a noted deficiency related
·2· · · ··to it?
·3· ·A· ··I don't know that there was a noted deficiency
·4· · · ··related to it.··I would anticipate that, you know,
·5· · · ··somewhere in these seven pages Noah may have made a
·6· · · ··comment about the SOP and the need to submit an
·7· · · ··updated SOP with the associated validation,
·8· · · ··required documentation, etc.··But without reading
·9· · · ··the document I can't -- I can't verify whether or
10· · · ··not that note exists.
11· · · · · · · · ··I do note right here at the beginning it
12· · · ··says that the facility has several methods which do
13· · · ··not adhere to the SMPRs published in February,
14· · · ··including heavy metals, residual solvents.··And
15· · · ··despite the fact that the semi-annual inspection
16· · · ··passed, that is still a note to the licensee.
17· ·Q· ··So I want to direct your attention to the top of
18· · · ··page 2.
19· ·A· ··Thank you, sir.
20· ·Q· ··Now, I believe this was -- this is very similar to
21· · · ··what we looked at in December of 2020 that there
22· · · ··was a, I won't say a deficiency because it
23· · · ··indicates there were no deficiencies, but there is
24· · · ··this comment related to the rule and -- about the
25· · · ··written SOP, and then there's a comment, it looks

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·1· · · ··like it was a response from Viridis again stating
·2· · · ··"The procedure has not changed.··Staff training and
·3· · · ··standardization of sample handling were conducted
·4· · · ··to improve consistency between laboratories in
·5· · · ··2020.··Additional sample handling details were
·6· · · ··added to the procedure at the request of the MRA
·7· · · ··and sent to them on December 3rd."
·9· ·A· ··Yes, you did read that correctly.
10· ·Q· ··Okay.
11· ·A· ··And that is the response from Viridis, correct,
12· · · ··asserting that the procedure has not changed?
13· ·Q· ··Correct.··Is that right?··Do you believe that's
14· · · ··correct?
15· ·A· ··Yes, I believe that that is what Viridis wrote as
16· · · ··their response.
17· ·Q· ··And passed the inspection?
18· ·A· ··Yes, passed the inspection.
19· · · · · · · · ··But again, to clarify, the procedure did
20· · · ··change.··And we don't look at our standard
21· · · ··operating procedures on our Semi-Annual Inspection
22· · · ··Reports.··I just -- I want to make sure that I'm
23· · · ··abundantly clear about that piece.
24· · · · · · · · ··JUDGE GOLDSTEIN:··I'm not clear.··I just
25· · · ··want to interject.··I want to better understand

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·1· · · ··this.··Sorry to interrupt, Counsel.
·2· · · · · · · · ··MR. RUSSELL:··That's fine, Your Honor.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··When you -- okay, if
·4· · · ··they are deviating from the SOP in the semi-annual
·5· · · ··inspection, and you don't address that as a
·6· · · ··deficiency and fail them at the inspection --
·7· · · · · · · · ··THE WITNESS:··Uh-huh.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··-- level, the entire
·9· · · ··inspection, because they may have passed other
10· · · ··parts of the inspection; right?
11· · · · · · · · ··THE WITNESS:··That is correct.
12· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Well, what
13· · · ··proceeding do you undertake to enforce the SOP?
14· · · · · · · · ··THE WITNESS:··So the semi-annual
15· · · ··inspections are based on those checklists that are
16· · · ··created on a snapshot of the administrative rules.
17· · · · · · · · ··Now, the compliance with the specific SOP
18· · · ··that is on file is not included in the semi-annual
19· · · ··inspection checklist, at least it was not at this
20· · · ··time.··It is, however, now with our new
22· · · · · · · · ··But during this point in time we would
23· · · ··address that rule violation through the process of
24· · · ··investigation.··And at this point in time we had
25· · · ··opened a number of investigations related to this

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·1· · · ··complaint in the deviations from the procedure that
·2· · · ··was approved in May of 2020.··And please let me
·3· · · ··know if I can provide any additional clarification
·4· · · ··or information, Your Honor.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So you didn't
·6· · · ··address the SOP, did you, through the more informal
·7· · · ··semi-annual inspection?
·8· · · · · · · · ··THE WITNESS:··That is correct, Your
·9· · · ··Honor.
10· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··You addressed it
11· · · ··through the complaint process, more or less,
12· · · ··ultimately?
13· · · · · · · · ··THE WITNESS:··Yes, Your Honor.
14· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So that's how
15· · · ··you pursued this, this violation.
16· · · · · · · · ··Now, another question.··We've just talked
17· · · ··about a number of Method Approval Reports, and in
18· · · ··the top right corner it has the method name, SOP
19· · · ··number.··Are we talking just about method name, SOP
20· · · ··number, related to potency testing?
21· · · · · · · · ··THE WITNESS:··No.··So those Method
22· · · ··Approval Reports can refer to any method that we
23· · · ··require through the Agency, so that may be any
24· · · ··number of potency, microbial tests, residual
25· · · ··solvents, etc.··It also keeps track of methods that

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·1· · · ··we don't require, like terpene analysis and
·2· · · ··occasionally things like genetic identification and
·3· · · ··various things like that.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··So the Method Approval
·5· · · ··Report would be filed for something like Viridis's
·6· · · ··current approved SOP?
·7· · · · · · · · ··THE WITNESS:··So if Viridis is --
·8· · · · · · · · ··JUDGE GOLDSTEIN:··In defense for their
·9· · · ··method of testing potency.
10· · · · · · · · ··THE WITNESS:··Would you repeat that last
11· · · ··part again?··I'm sorry.
12· · · · · · · · ··JUDGE GOLDSTEIN:··Is there some Method
13· · · ··Approval Report that's in existence right now at
14· · · ··the Agency regarding their -- the potency testing
15· · · ··method that you now contend is unapproved?
16· · · · · · · · ··THE WITNESS:··So there is a method denial
17· · · ··for the potency method that is in contention here
18· · · ··once it was submitted to the Agency in June of
19· · · ··2021.
20· · · · · · · · ··So we had those back-and-forth
21· · · ··communications, the CRA email communications, to
22· · · ··Viridis between November of 2020 and June of
23· · · ··2021 --
24· · · · · · · · ··JUDGE GOLDSTEIN:··Let me stop you.
25· · · · · · · · ··Are there method approval -- is there a

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·1· · · ··-- prior to this point was there a Method Approval
·2· · · ··Report in place, the particular method at issue in
·3· · · ··this case, potency testing?
·4· · · · · · · · ··THE WITNESS:··Yes, there was a Method
·5· · · ··Approval Report in place for potency testing.··Yes,
·6· · · ··sir.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Potency testing.
·8· · · · · · · · ··Now, on each Method Approval Reports I'm
·9· · · ··looking at -- all of them had a potency section.
10· · · ··Matrix flower.··That's what they're testing?··Does
11· · · ··that mean they're testing flower?
12· · · · · · · · ··THE WITNESS:··That's correct.
13· · · · · · · · ··JUDGE GOLDSTEIN:··And part of the problem
14· · · ··here is we're going through those Method Approval
15· · · ··Reports and there's no explanation as to what all
16· · · ··this means.··Okay?··Now, perhaps that will come out
17· · · ··on redirect.
18· · · · · · · · ··But what is the exact -- what does this
19· · · ··mean?··Under potency, for example, on the detection
20· · · ··of aspergillus by gene-up LOM 21 detection, that
21· · · ··particular Exhibit 11, Viridis Exhibit 11, the
22· · · ··first page, potency.··Flower.··Then it says
23· · · ··"accept, accept, accept."
24· · · · · · · · ··What does all that mean, Ms. Patterson?
25· · · ··Why does it say "accept" there yet -- explain the

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·1· · · ··difference to the Tribunal.··How do I interpret
·2· · · ··this?
·3· · · · · · · · ··It says accept there but then it has
·4· · · ··comments there.··So what does this exactly mean in
·5· · · ··terms of -- does this prove that they weren't
·6· · · ··following the method?··Does it not prove anything?
·7· · · ··What does this mean here?
·8· · · · · · · · ··THE WITNESS:··So the places where it says
·9· · · ··"accept" means that something was submitted to the
10· · · ··Agency that would be a method submission.··So that
11· · · ··would be an SOP, the associated validation
12· · · ··documents, potentially a proficiency test or
13· · · ··potentially a response from the licensee to the
14· · · ··Agency.··And that just notes that we accept that
15· · · ··method and the associated submissions.··And those
16· · · ··are dated.··I believe the ones that you may be
17· · · ··referring to where there's a quick succession of
18· · · ··lines, those may have been related directly to
19· · · ··proficiency tests associated withs potency.··And
20· · · ··so --
21· · · · · · · · ··JUDGE GOLDSTEIN:··I want you to -- so
22· · · ··that I understand this -- you're going to have to
23· · · ··understand that everybody's got to assume the
24· · · ··Tribunal knows nothing about this.··Okay?··So
25· · · ··introducing these documents, Method Approval

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·1· · · ··Reports, without explaining what they mean is not
·2· · · ··going to help me come time writing the decision.
·3· · · · · · · · ··Pull up Exhibit 11, Viridis Exhibit 11,
·4· · · ··if you can share that on our screen for me,
·5· · · ··Counsel.··Go to the first page, please.··All right.
·6· · · · · · · · ··Ms. Patterson, explain -- we have a
·7· · · ··method SOP number, LOM detection.··What exactly
·8· · · ··does this mean?··What is this Method Approval
·9· · · ··Report?··Does this approve a method for testing
10· · · ··aspergillus?
11· · · · · · · · ··THE WITNESS:··No.··So this is just a
12· · · ··summary of the things that they have been approved
13· · · ··for.··And so this is essentially a living document
14· · · ··that documents when approvals or denials happened.
15· · · ··And there's also an associated document that goes
16· · · ··with this when a licensee submits a validation or a
17· · · ··verification to the Agency, and that's the Method
18· · · ··Validation Report.··And the Method Validation
19· · · ··Report has a lot more detail than this does here.
20· · · · · · · · ··JUDGE GOLDSTEIN:··So what is this in the
21· · · ··top right box here, "Method name, SOP number"?
22· · · · · · · · ··THE WITNESS:··Uh-huh.
23· · · · · · · · ··JUDGE GOLDSTEIN:··What does that
24· · · ··identifier mean to the Agency?
25· · · · · · · · ··THE WITNESS:··So what this means to the

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·1· · · ··Agency is that there was a method by this name that
·2· · · ··was submitted to us through the official pathways,
·3· · · ··including the official documentation and
·4· · · ··requirements, and that we're going to update this
·5· · · ··living document to include that SOP and notes, very
·6· · · ··brief notes, about the submission itself, and then
·7· · · ··whether or not it was accepted or denied by the
·8· · · ··Agency.
·9· · · · · · · · ··And, again, that would have some sort of
10· · · ··associated method validation document that would
11· · · ··provide more detailed scientific notes.
12· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··So do these
13· · · ··documents have anything to do with the method under
14· · · ··review?
15· · · · · · · · ··THE WITNESS:··These documents, in my
16· · · ··opinion, have nothing to do with the method under
17· · · ··review until the method --
18· · · · · · · · ··JUDGE GOLDSTEIN:··Their Method Approval
19· · · ··Report that's been admitted so far, that will be
20· · · ··admitted, the Method Approval Report related to the
21· · · ··method that is under dispute here.
22· · · · · · · · ··THE WITNESS:··Not directly in my opinion,
23· · · ··no, sir.
25· · · · · · · · ··THE WITNESS:··Because the licensee did

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·1· · · ··not provide that method to us with its full
·2· · · ··validation, the associated documents, etc. --
·4· · · · · · · · ··THE WITNESS:··-- until -- well, I don't
·5· · · ··know if they ever did, actually.
·6· · · · · · · · ··MR. RUSSELL:··Your Honor, to clarify what
·7· · · ··you asked earlier about the -- whether there's a
·8· · · ··Method Approval Report, I believe the testimony
·9· · · ··earlier as to the contention by the CRA that the
10· · · ··method that is approved right now is from May 2020,
11· · · ··as you can see on all these Method Approval Reports
12· · · ··it's not noted.··I have not seen a Method Approval
13· · · ··Report, and I believe the testimony was there was
14· · · ··never a Method Approval Report submitted from the
15· · · ··CRA related to the May 2020 SOP that they now claim
16· · · ··is the one that is in effect.
17· · · · · · · · ··MS. HUYSER:··I will rely on the Court's
18· · · ··recognition of the testimony, but I do believe that
19· · · ··Ms. Patterson did answer that question specifically
20· · · ··why the May date is not there, and she provided
21· · · ··further explanation as to that's because it was not
22· · · ··a substantive change to the January and she
23· · · ··explained that again.
24· · · · · · · · ··Obviously I don't want to get into a
25· · · ··back-and-forth argument, but so the ALJ and the

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·1· · · ··Court will have the record clear I just didn't want
·2· · · ··to leave what could potentially be a
·3· · · ··mischaracterization of testimony.
·4· · · · · · · · ··MR. RUSSELL:··And, Sarah, I appreciate
·5· · · ··that, and I'm not trying to mischaracterize
·7· · · · · · · · ··But I think, Judge, what you asked
·8· · · ··specifically was is there a Method Approval Report
·9· · · ··for the May 2020 method which they claim is the one
10· · · ··that's the last one approved, and I believe -- I
11· · · ··mean, obviously Ms. Patterson can correct me if I'm
12· · · ··wrong, but the testimony was there was not a Method
13· · · ··Approval Report that was sent out for that May 2020
14· · · ··approval.
15· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··So was
16· · · ··there a May -- was there a Method Approval Report
17· · · ··sent out from the January 2020?
18· · · · · · · · ··THE WITNESS:··Yes, there was.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··And has that
20· · · ··been admitted into evidence yet?··Does that exist
21· · · ··somewhere so I can see what specific method and how
22· · · ··these method review reports tie into the issues in
23· · · ··this case?··I think that's where I'm unclear.
24· · · · · · · · ··We are talking about a bunch of them, and
25· · · ··they all talk about potency testing, method review

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·1· · · ··reports for different things.
·2· · · · · · · · ··MS. HUYSER:··Your Honor, can I just
·3· · · ··clarify just to make sure I'm understanding
·4· · · ··correctly?
·5· · · · · · · · ··Your Honor, the January of 2020 is
·6· · · ··referenced.··If we were to scroll below you'd be
·7· · · ··able to see that that is the last line on there.
·8· · · · · · · · ··If there is any other reference to the
·9· · · ··December or anything else that comes past this you
10· · · ··won't see that in the exhibits --
11· · · · · · · · ··JUDGE GOLDSTEIN:··What line are you
12· · · ··talking about?··I'm sorry.
13· · · · · · · · ··MS. HUYSER:··Sorry.··If we continue to go
14· · · ··down --
15· · · · · · · · ··JUDGE GOLDSTEIN:··On the first page?
16· · · · · · · · ··MS. HUYSER:··I believe potency's on the
17· · · ··second page.··I'd have to look at it as we go
18· · · ··through.··If we go to page 2.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Potency starts on the
20· · · ··first page.
21· · · · · · · · ··MS. HUYSER:··Okay.··Okay.··So what you're
22· · · ··seeing here is reference to the January of 2020.
23· · · ··And, obviously, we've now talked about the May of
24· · · ··2020 nonsubstantive change that there was an
25· · · ··exhibit admitted through our direct that outlined

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·1· · · ··that procedure, and then there has been additional
·2· · · ··documents presented that had this January of 2020
·3· · · ··and a little more of a cohesive explanation that
·4· · · ··were admitted through us as well.
·5· · · · · · · · ··And then what you'll see for the other
·6· · · ··ones will look a little different as they come
·7· · · ··forward based on the -- and I, again, don't want to
·8· · · ··be testifying, just trying to --
·9· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··All right.
10· · · · · · · · ··MR. RUSSELL:··Your Honor, can I respond
11· · · ··to that though?
12· · · · · · · · ··JUDGE GOLDSTEIN:··Is this more of a
13· · · ··timeline then --
14· · · · · · · · ··MS. HUYSER:··Yes.
15· · · · · · · · ··JUDGE GOLDSTEIN:··-- of events?
16· · · · · · · · ··MS. HUYSER:··Yes.
17· · · · · · · · ··JUDGE GOLDSTEIN:··Is that how I should be
18· · · ··reading this -- this?
19· · · · · · · · ··All right.··So this potency here,
20· · · ··1/3/2020 under PT results?··And what does that mean
21· · · ··again?
22· · · · · · · · ··MS. HUYSER:··External flower proficiency
23· · · ··test.
24· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··And those are
25· · · ··done by other labs; right?

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·1· · · · · · · · ··THE WITNESS:··Yes, Your Honor.
·2· · · · · · · · ··MS. HUYSER:··Yes.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Am I understanding that
·4· · · ··correctly?··Okay.
·5· · · · · · · · ··So January 3rd, 2020, is the last,
·6· · · ··roughly, approval on file?
·7· · · · · · · · ··THE WITNESS:··Yes, Your Honor.
·9· · · · · · · · ··MR. RUSSELL:··Judge, if I can clarify one
10· · · ··thing, I mean, I think this is an extremely
11· · · ··important point that you're raising here, and I
12· · · ··want to make sure that the record is clear on this.
13· · · · · · · · ··I agree there was an approval of January
14· · · ··2020, and that's -- that's been noted.
15· · · · · · · · ··There was an updated SOP in May of 2020
16· · · ··which they've testified -- the CRA has testified to
17· · · ··that is the last approved SOP.
18· · · · · · · · ··Now, there wasn't a method approval sent.
19· · · ··It's not on any of these Method Approval Reports.
20· · · ··The testimony is that it was because there wasn't a
21· · · ··significant change.··Regardless of whether it was
22· · · ··or not, when you look at all these Method Approval
23· · · ··Reports updates are provided for all the different
24· · · ··testing methods, and this one is never put on
25· · · ··there.

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·1· · · · · · · · ··Why this is important is because we've
·2· · · ··obviously indicated to the Court that another
·3· · · ··method was updated in November 2020, sent again on
·4· · · ··December 3rd, 2020, that was also accepted.··And
·5· · · ··while that's not noted either, it's the same
·6· · · ··situation from May 2020.
·7· · · · · · · · ··MS. HUYSER:··Your Honor, at this point I
·8· · · ··think we're getting beyond -- we're getting into
·9· · · ··exactly what the argument portion of this would be
10· · · ··as far as what each interpretation and what the
11· · · ··exact genuine issue of material fact is.··I can
12· · · ··appreciate that that's Mr. Russell's position.
13· · · ··Obviously, this Court is aware that we have a
14· · · ··different position based on the testimony.··But I
15· · · ··just want it to be clear that this is more argument
16· · · ··that's being presented where obviously that comes
17· · · ··down to in your hands to issue the PFD and to
18· · · ··interpret why it's there and why it's not there
19· · · ··based on the evidence presented.
20· · · · · · · · ··MR. RUSSELL:··And, Sarah, I'm not trying
21· · · ··to argue, I'm just trying to clear the record for
22· · · ··the timeline.
23· · · · · · · · ··MS. HUYSER:··With all due respect, I
24· · · ··appreciate that, but I feel like it's -- you're
25· · · ··clearing, like, your version of the timeline.

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·1· · · ··Obviously, I can offer something different with
·2· · · ··that.··So I'm just making sure that we're on the
·3· · · ··same page that that's where -- exactly where the
·4· · · ··argument lies, whichever side it goes.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··I see what you're
·6· · · ··saying, Counsel.··You're trying to get me to
·7· · · ··understand why it's important that I ask what this
·8· · · ··means, but, on the other hand, I see Ms. Huyser's
·9· · · ··concern that you're kind of reading into the
10· · · ··absence of any information there as some kind of
11· · · ··indication that there's some untoward reason for
12· · · ··its omission.
13· · · · · · · · ··So that -- you know, whether I accept
14· · · ··Ms. Patterson's explanation for why it's not
15· · · ··included is ultimately up to me, but I appreciate
16· · · ··it.
17· · · · · · · · ··So we're talking, then, that these Method
18· · · ··Approval Reports, for example, like water activity,
19· · · ··the second one listed there, that's a method that
20· · · ··they've submitted in the past for water activity
21· · · ··testing?
23· · · · · · · · ··JUDGE GOLDSTEIN:··Is that correct,
24· · · ··Ms. Patterson?

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Very good.
·2· · · ··I will leave it at that and return it to Counsel
·3· · · ··for any -- for -- to continue examination.··I just
·4· · · ··needed to get that clear in my own head.··Thank
·5· · · ··you.
·6· · · · · · · · ··MR. RUSSELL:··Sorry, Your Honor, just
·7· · · ··trying to get back to my outline to determine where
·8· · · ··we left off when we started down that line of
·9· · · ··questioning.
10· · · · · · · · ··JUDGE GOLDSTEIN:··Oh, you got cut out
11· · · ··there.··You're -- I didn't hear half of what you
12· · · ··said.
13· · · · · · · · ··MR. RUSSELL:··Oh, I'm sorry, Your Honor,
14· · · ··I was just trying to get back in my timeline to
15· · · ··figure out where we left off.··I know we were on I
16· · · ··believe Exhibit 18C.··Is that correct?··Okay.
17· · · · · · · · ··If you want to bring that back up.
18· · · · · · · · ··I apologize, Your Honor.··Do you mind if
19· · · ··we take a ten-minute break?
20· · · · · · · · ··JUDGE GOLDSTEIN:··No, not at all.··We'll
21· · · ··just break till 3:30.··Okay?··About 12 minutes.
22· · · · · · · · ··MR. RUSSELL:··All right.··Thank you.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Off the record at 3:19.
24· · · · · · · · ··(Break taken at 3:19 PM)

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Back on the record in
·3· · · ··Viridis North versus Cannabis Regulatory Agency,
·4· · · ··consolidated Dockets 21-029794, et al.··The time is
·5· · · ··3:31 PM.
·6· · · · · · · · ··Counsel, you may proceed.
·8· ·Q· ··(MR. RUSSELL) Ms. Patterson, I'm going to show you
·9· · · ··what's previously been marked as Exhibit 19C.
10· · · · · · · · ··MR. RUSSELL:··And, Judge, I know that you
11· · · ··indicated that you didn't have 18C, so I'm guessing
12· · · ··you don't have 19C.··To the extent you don't, I
13· · · ··will make sure we get that to you afterwards.
14· · · · · · · · ··JUDGE GOLDSTEIN:··No, I'm going -- I'm
15· · · ··missing 16, 17, 18, 19, and 20.
16· · · · · · · · ··MR. RUSSELL:··Okay.
17· · · · · · · · ··JUDGE GOLDSTEIN:··The progression you
18· · · ··sent here.
19· · · · · · · · ··MR. RUSSELL:··All right.
20· · · · · · · · ··JUDGE GOLDSTEIN:··And they actually look
21· · · ··like the period between how you've marked them,
22· · · ··you've described them April 28th, 2021, Method
23· · · ··Approval Report is 15.··21 is marked as Method
24· · · ··Approval Report for Viridis North, LLC.
25· ·Q· ··(MR. RUSSELL) Ms. Patterson, do you recognize this

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·1· · · ··document?
·2· ·A· ··This document appears to be a Semi-Annual
·3· · · ··Inspection Report as well as, potentially,
·4· · · ··responses from the licensee.
·5· ·Q· ··Okay.··And is this an accurate depiction of what --
·6· · · ··this looks like a June 8th, 2021, inspection report
·7· · · ··for Viridis North?
·8· ·A· ··Yes, sir.
·9· · · · · · · · ··MR. RUSSELL:··Okay.··I would ask to admit
10· · · ··this as Exhibit 13.
12· · · · · · · · ··JUDGE GOLDSTEIN:··I forgot I muted
13· · · ··myself.
14· · · · · · · · ··You'll submit that after the hearing;
15· · · ··correct?
16· · · · · · · · ··MR. RUSSELL:··Yes, I will.
17· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··All right.
18· · · ··Viridis Exhibit 13 is admitted.
22· ·Q· ··(MR. RUSSELL) Ms. Patterson, similar to the Exhibit
23· · · ··12 that we just looked at, this appears, although
24· · · ··this is from Viridis North and that was Viridis
25· · · ··Laboratories, it appears that there were no

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·1· · · ··deficiencies found during the semi-annual
·2· · · ··inspection on June 8th, 2021, at Viridis North; is
·3· · · ··that correct?
·4· ·A· ··Yes, sir, as it relates to the semi-annual
·5· · · ··inspection, that is correct.
·6· ·Q· ··And do you know if these were on-site audits for
·7· · · ··Viridis Laboratories and Viridis North in June
·8· · · ··2021?
·9· ·A· ··I believe so, yes, sir.
10· ·Q· ··Okay.··So the laboratory scientists came on site to
11· · · ··do these inspections and actually watch both the
12· · · ··laboratories test potency?
13· ·A· ··I know for certain that it occurred at the Viridis
14· · · ··Lansing location, and I do believe it also occurred
15· · · ··at the Viridis North location.
16· · · · · · · · ··MR. RUSSELL:··You can take it town.
17· ·Q· ··(MR. RUSSELL) Were you present for -- for that?
18· ·A· ··At the Viridis Lansing location, yes, sir, I was.
19· ·Q· ··Okay.··So when you say that, as part of the June
20· · · ··2021 semi-annual inspection you were present?
21· ·A· ··Yes, sir.
22· ·Q· ··Who else was at that in-person inspection?
23· ·A· ··Noah Rosenzweig.
24· ·Q· ··Okay.··Is it typical to have more than one
25· · · ··scientist at one of the semi-annual inspections?

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·1· ·A· ··Yes, sir.
·2· ·Q· ··Usually there's more than one?
·3· ·A· ··Yes, sir.
·4· ·Q· ··All right.··And so you personally viewed the
·5· · · ··potency method being tested at Viridis Laboratories
·6· · · ··in June 2021?
·7· ·A· ··During the on-site at Viridis Laboratories in June
·8· · · ··of 2021 Noah Rosenzweig was actually reviewing the
·9· · · ··audit portion of the potency.··He was taking notes
10· · · ··during that time.··And I believe I previously
11· · · ··testified that I was speaking to Michele Glinn at
12· · · ··that time.
13· ·Q· ··So we talked -- we testified about this earlier.
14· · · ··You indicated that the quality assurance at both of
15· · · ··the Viridis laboratories I think your word was in
16· · · ··disarray.
17· · · · · · · · ··Both the laboratories, not only in
18· · · ··December 2020 -- well, actually going back to July
19· · · ··of 2020 and then December 2020 and then also in
20· · · ··June of 2021 all passed the semi-annual
21· · · ··inspections?
22· ·A· ··Yes, sir, they did.
23· ·Q· ··Okay.··So there was no -- there was no
24· · · ··determination that there was a rule violation by
25· · · ··either of the laboratories during that time period?

(517) 388-3128
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·1· ·A· ··At that time period we had determined that there
·2· · · ··were violations related to deviations in the
·3· · · ··approved potency method.··But I do want to clarify
·4· · · ··that my significant concerns related to oversight
·5· · · ··and quality management came later when we started
·6· · · ··talking about the deviations from the microbial --
·7· · · ··microbial procedures.··And so that actually
·8· · · ··occurred after the June 2021 semi-annual
·9· · · ··inspection.
10· ·Q· ··Did that occur after the July 2021 proficiency
11· · · ··tests where all passed by the laboratory?
12· ·A· ··Can you clarify?··You mean the external proficiency
13· · · ··test that was noted on the method approval summary?
14· ·Q· ··Yes.
15· ·A· ··Yes, sir, that occurred after that date.
16· ·Q· ··So if I hear your testimony correctly then, as of
17· · · ··July 2020, December 2020, and June 2021, you didn't
18· · · ··find any quality assurance issues at either of the
19· · · ··laboratories?
20· ·A· ··At that point in time we had not identified any
21· · · ··significant quality assurance issues that were
22· · · ··noted on the Semi-Annual Inspection Report, that is
23· · · ··correct.
24· ·Q· ··Okay.··And so both laboratories during that time
25· · · ··frame of July 2020, December 2020, and June 2021

(517) 388-3128
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·1· · · ··had a laboratory manager in place that was meeting
·2· · · ··your expectations, whatever that would be?
·3· ·A· ··Aside from the fact that they were not ensuring
·4· · · ··that their technicians were following the approved
·5· · · ··SOP for potency that was approved by the Agency I
·6· · · ··did not have other significant concerns at that
·7· · · ··time, no.
·8· ·Q· ··Okay.··So in the -- the Judge was just asking you
·9· · · ··about why this wasn't -- these concerns that you're
10· · · ··talking about weren't part of the semi-annual
11· · · ··inspection, and I believe that your testimony was
12· · · ··that it was taken through the investigation
13· · · ··process.··Is that correct?
14· ·A· ··Yes, sir.
15· ·Q· ··Okay.··And so I believe that that investigation
16· · · ··process began in March of 2021.··Would you agree
17· · · ··with me?
18· ·A· ··No, sir, I believe that investigation process
19· · · ··actually began in January of 2021 just after the
20· · · ··December of 2020 semi-annual inspection and audit
21· · · ··had occurred.
22· ·Q· ··Right.··And I think that's correct.
23· · · · · · · · ··So would it be fair to say that the
24· · · ··December 2020 semi-annual inspection was actually
25· · · ··used as an investigation tool for what would

(517) 388-3128
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·1· · · ··eventually become your first investigative report
·2· · · ··as it related to potency on March 10th, 2021?
·3· ·A· ··No, sir.··The semi-annual inspection was and very
·4· · · ··frequently is used as both a semi-annual inspection
·5· · · ··as well as an audit of laboratory procedures and
·6· · · ··operations.
·7· ·Q· ··Okay.··And you didn't make either one of the
·8· · · ··laboratories aware that there was an audit that was
·9· · · ··occurring in December 2020, did you?
10· ·A· ··This is commonplace with every semi-annual
11· · · ··inspection that we have ever performed.··They have
12· · · ··been subject to this a number of times.
13· ·Q· ··Okay.··So you just testified that you opened up an
14· · · ··investigation in January 2021 based on what you
15· · · ··witnessed at the December 2020 semi-annual
16· · · ··inspection that both the laboratories passed?
17· ·A· ··Yes, based on the fact that they were not following
18· · · ··the SOP that was approved by the Agency, that is a
19· · · ··violation of the administrative rules and therefore
20· · · ··we had no choice but to open an investigation.
21· ·Q· ··So you open up an investigation, and you didn't
22· · · ··tell either one of the Viridis laboratories that an
23· · · ··investigation had been opened; correct?
24· ·A· ··I do not recall if we specifically or explicitly
25· · · ··told them that an investigation had been opened up;

(517) 388-3128
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·1· · · ··however, Dr. Rosenzweig did note on his Semi-Annual
·2· · · ··Inspection Report that there was a rule violation
·3· · · ··there.··So I do believe that that information was
·4· · · ··present for the licensee to see and to digest.
·5· ·Q· ··I just have trouble with that explanation
·6· · · ··considering the fact that on all four of the
·7· · · ··Semi-Annual Inspection Reports the response from
·8· · · ··both the laboratories was specifically that they
·9· · · ··were using the same method that had been provided
10· · · ··to you on December 3rd, 2020, and on both of those
11· · · ··the response accepted, passed, passed.
12· · · · · · · · ··So the laboratories from November 2020
13· · · ··when you received the updated SOP until June 2021,
14· · · ··seven months, all they had was that you had
15· · · ··received an updated SOP, that you had passed them
16· · · ··on four semi-annual inspections and had noted a
17· · · ··potential deficiency and accepted their response.
18· · · ··Then you opened up an investigation in January 2021
19· · · ··and had previously testified that you didn't notify
20· · · ··them of the investigation.
21· · · · · · · · ··Am I wrong about any of that?
22· ·A· ··No, sir.··I would like to reiterate that we did
23· · · ··state that there was a violation of the
24· · · ··administrative rules.··Despite the fact that it may
25· · · ··not have been captured in the semi-annual

(517) 388-3128
Page 418
·1· · · ··inspection, that information was noted on that
·2· · · ··report.
·3· · · · · · · · ··Additionally, I had numerous email
·4· · · ··communications with the licensee notifying them
·5· · · ··that what they were doing was in question and that
·6· · · ··we had concerns about how the method was being
·7· · · ··performed in the laboratory space.
·8· ·Q· ··Well, you're talking about the November 2021 --
·9· · · ··November 2020 back-and-forth emails with Dr. Glinn.
10· · · · · · · · ··So you go from November 2020 when you
11· · · ··received the updated SOP to June 2021, seven
12· · · ··months, four passed semi-annual inspections without
13· · · ··any phone calls, any emails, anything saying that
14· · · ··the method you're using isn't approved.··You need
15· · · ··to stop.··You need to use this other method that is
16· · · ··approved in May 2020 even though we don't have any
17· · · ··Method Approval Report for that.··Correct?
18· ·A· ··That is correct, though I would like to clarify
19· · · ··that during that period of time we were also
20· · · ··seeking to gain additional information from the
21· · · ··laboratory.··And you'll note that there is a
22· · · ··significant deviation between the method that was
23· · · ··submitted in December of 2020 and what was
24· · · ··witnessed on site in June of 2021.··So it indicates
25· · · ··that there was actually yet another change to the

(517) 388-3128
Page 419
·1· · · ··method during that period of time.
·2· ·Q· ··You signed, and we'll get into it, probably not
·3· · · ··today, but you signed a formal complaint, you being
·4· · · ··Claire Patterson, on August 25th, 2021.··Do you
·5· · · ··recall that?
·6· ·A· ··I don't recall that exactly, but I believe that I
·7· · · ··may have signed a complaint, yes, sir.
·8· ·Q· ··Okay.··So in that complaint as part of it you
·9· · · ··allege that this issue with the -- what you claimed
10· · · ··was not following an approved SOP was a public
11· · · ··health and safety issue.··Am I wrong about that?
12· ·A· ··It's certainly possible, sir.··Again, I'd have to
13· · · ··reference the document, but I believe the
14· · · ··document --
15· ·Q· ··I mean, you are the -- the scientific manager.··I
16· · · ··would think you would know if there was a health
17· · · ··and safety issue with one of your 19 laboratories.
18· · · ··Wouldn't that be the case?
19· ·A· ··Yes, sir.··Absolutely.··I'm not disputing that
20· · · ··fact.
21· ·Q· ··Okay.··So I just want to be clear then.
22· · · · · · · · ··So you have from November to August 2021
23· · · ··when you -- when you finally issued this formal
24· · · ··complaint, and you're claiming or alleging in that
25· · · ··complaint, which we'll get to next time, that

(517) 388-3128
Page 420
·1· · · ··public health and safety issue, this is a public
·2· · · ··health and safety issue, but you never let the
·3· · · ··laboratories know that there's any issue.··You
·4· · · ··continued to allow them to test using this potency
·5· · · ··method which now has been certified by the AOAC,
·6· · · ··but you never let them know that it's your position
·7· · · ··that it's not a reliable method.··In fact, you
·8· · · ··allege that there's fraud.··And you started an
·9· · · ··investigation.··January 2021 an investigation
10· · · ··report is submitted and approved, is submitted on
11· · · ··March 10th, 2021, by Noah Rosenzweig --
12· · · · · · · · ··MS. HUYSER:··Your Honor, at this point in
13· · · ··time this question has gone through a whole litany
14· · · ··of things and it sounds more like testimony than a
15· · · ··question, so I would object at this point.··Is
16· · · ··there a question, or are we testifying?
17· ·Q· ··(MR. RUSSELL) So the question -- the question is
18· · · ··this.··Was there an investigation report that was
19· · · ··submitted by Noah Rosenzweig that you're aware of
20· · · ··on March 10, 2021?
21· ·A· ··Yes, sir.
22· ·Q· ··Okay.··And was the substance of that investigation
23· · · ··report all related to the December 2020 semi-annual
24· · · ··inspection?
25· ·A· ··I believe so, yes, sir.

(517) 388-3128
Page 421
·1· ·Q· ··Okay.··And you never made either one of the Viridis
·2· · · ··laboratories aware that the investigation was
·3· · · ··occurring or that the report had been submitted on
·4· · · ··March 10th, 2021; correct?
·5· ·A· ··I do believe that we made Viridis Laboratories
·6· · · ··aware that we were looking into their methods,
·7· · · ··though it is not our practice to notify a
·8· · · ··laboratory, or at least it was not at that time,
·9· · · ··that we are submitting an investigation report for
10· · · ··review.
11· ·Q· ··But, in fact, you've actually changed that policy
12· · · ··now where you do let licensees know when you're
13· · · ··conducting an investigation; correct?
14· ·A· ··Yes, absolutely.··In the name of process
15· · · ··improvement we continued to improve those processes
16· · · ··and will continue to do so throughout time.
17· ·Q· ··And you would agree that that was a poor process
18· · · ··that you had in place?
19· ·A· ··I'm not going to speak to the quality of it, it was
20· · · ··simply the process that was in place at that time.
21· ·Q· ··And that was your process; correct?
22· ·A· ··No, sir.
23· ·Q· ··I guess another question that I have related to
24· · · ··notification would be more so to the consumers not
25· · · ··just the licensee.··Obviously we're here based on

(517) 388-3128
Page 422
·1· · · ··the fact that you now claim that there was a
·2· · · ··violation, they weren't complying with the SOP,
·3· · · ··although they were passed four times at their
·4· · · ··semi-annual inspections.··But -- so you went this
·5· · · ··whole time and as of today they're still using the
·6· · · ··same testing method, and you've never notified the
·7· · · ··consumers about that; correct?
·8· ·A· ··This has been under investigation for a period of
·9· · · ··time.··I'm not entirely sure that it would be
10· · · ··appropriate to notify consumers of that.
11· · · · · · · · ··MR. RUSSELL:··Your Honor, I know we're
12· · · ··going to quit at four.··Do you -- I -- I have
13· · · ··another -- well, a lot of documents I'm going to
14· · · ··introduce, but I'm wondering if you want me to
15· · · ··start on that or wait till our next hearing date.
16· · · · · · · · ··JUDGE GOLDSTEIN:··You mean it would take
17· · · ··you some time to do all that?··It's a different
18· · · ··topic, subject matter area?
19· · · · · · · · ··MR. RUSSELL:··Well, I'm going to get into
20· · · ··the investigative report itself, so yeah, it will
21· · · ··take some time.
22· · · · · · · · ··JUDGE GOLDSTEIN:··That's fine.··If you
23· · · ··want to reserve that thought that's fine, and
24· · · ··we'll -- is that okay with you, Ms. Huyser, and
25· · · ··Ms. Hunt-Scully?

(517) 388-3128
Page 423
·1· · · · · · · · ··MS. HUYSER:··That's fine.
·2· · · · · · · · ··MS. HUNT-SCULLY:··(Moves head up and
·3· · · ··down)
·4· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··So I think
·5· · · ··we're set to meet next week; right?··Tuesday and
·6· · · ··Wednesday?
·7· · · · · · · · ··MR. RUSSELL:··Correct, Your Honor.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··We'll see
·9· · · ··everybody then.··We were off the record at 3:48 PM.
10· · · ··If you could make sure you get me those exhibits.
11· · · · · · · · ··MR. RUSSELL:··Yeah, we'll do, Your Honor.
12· · · · · · · · ··And also do we want to discuss the
13· · · ··possibility of additional days?··Obviously, we're
14· · · ··on our first witness, and I believe there are --
15· · · · · · · · ··MR. SCHUMACHER:··Possibly up to 15.
16· · · · · · · · ··MR. RUSSELL:··-- up to 15 witnesses.
17· · · · · · · · ··JUDGE GOLDSTEIN:··For who?··For --
18· · · ··combined?
19· · · · · · · · ··MR. RUSSELL:··Combined, yes.
21· · · · · · · · ··MS. HUYSER:··Your Honor, is it all right
22· · · ··if Ms. Patterson signs off so she doesn't have to
23· · · ··sit here during this process?
24· · · · · · · · ··JUDGE GOLDSTEIN:··Yes, that's fine.
25· · · · · · · · ··MS. HUYSER:··Thank you, Your Honor.

(517) 388-3128
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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you,
·2· · · ··Ms. Patterson.··Have a good day.
·3· · · · · · · · ··THE WITNESS:··You as well.
·4· · · · · · · · ··(The witness was excused.)
·5· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Okay.··I
·6· · · ··heard somebody whisper that they had something on
·7· · · ··the 12th.··Is that correct?
·8· · · · · · · · ··MR. SCHUMACHER:··Yes, Your Honor, I have
·9· · · ··a jury trial on the 12th.
10· · · · · · · · ··JUDGE GOLDSTEIN:··How about June 7th?
11· · · ··And let's see.··Does June 7th and 8th look open?
12· · · ··June 27, 28?
13· · · · · · · · ··MR. RUSSELL:··June 27th works for me,
15· · · · · · · · ··JUDGE GOLDSTEIN:··How about from the
16· · · ··Agency?
17· · · · · · · · ··MS. HUYSER:··Sorry, we're just looking
18· · · ··real quick.
19· · · · · · · · ··Yeah, we can make the 27th and 28th work.
20· · · · · · · · ··MS. HUNT-SCULLY:··Yeah, so I think that
21· · · ··Ms. Huyser and I are both available, but we'll have
22· · · ··to -- I mean, we don't know our witnesses's
23· · · ··schedules for -- you know, it's vacation times and
24· · · ··stuff.
25· · · · · · · · ··JUDGE GOLDSTEIN:··So 27, 28, accept those

(517) 388-3128
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·1· · · ··at this point, will that work for Counsel for
·2· · · ··Viridis too?
·3· · · · · · · · ··MR. RUSSELL:··The 27th works.··The 28th I
·4· · · ··have a scheduled hearing that morning.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Oh, you -- okay, yeah.
·6· · · ··So it's just the 27th then.
·7· · · · · · · · ··MR. RUSSELL:··Yep.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Let's pick
·9· · · ··another date if we can here.
10· · · · · · · · ··You know, July's calendar is already
11· · · ··looking really, you know, pretty full at this
12· · · ··point, but there is -- I do have a case in the
13· · · ··morning of the 24th, but I could probably do it at
14· · · ··1:30 in the afternoon.··We just wouldn't have all
15· · · ··day on July 24th.··Unless you just want a full day,
16· · · ··and then we're probably going into August at this
17· · · ··point because July already looks pretty full.
18· · · · · · · · ··MR. RUSSELL:··Your Honor, if we went into
19· · · ··August could we have two consecutive days?··I think
20· · · ··that be preferable.
21· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah, I -- how about
22· · · ··August 23rd and 24th?
23· · · · · · · · ··MR. RUSSELL:··That works for us.
24· · · · · · · · ··MS. HUYSER:··Yeah, at this point without
25· · · ··checking with our witnesses, obviously, we have to

(517) 388-3128
Page 426
·1· · · ··go through that process, but 23rd and 24th looks
·2· · · ··open.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··That way I don't
·4· · · ··forget between now and next week what we talked
·5· · · ··about.
·6· · · · · · · · ··All right.··August 23rd and 24th; right?
·7· · · · · · · · ··MR. RUSSELL:··Yes, Your Honor.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Okay, very good.
·9· · · ··We'll see everybody next week.··We are concluded
10· · · ··and off the record at 3:56 PM.
11· · · · · · · · ··Thanks, everybody.··Have a good evening.
13· · · · · · · · ··MS. HUYSER:··Thank you, Your Honor.
14· · · · · · · · ··(Record closed at 3:56 PM)
15· · · · · · · · · ··*· ··*· ··*· ··*· ··*
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·1· · · · · · · · ·CERTIFICATE OF NOTARY PUBLIC

· ··
·2· ·
· ··
·3· · · ··I certify that this transcript, consisting of··pages,
· ··
·4· ·is a complete, true, and correct transcript of the
· ··
·5· ·proceedings and testimony taken in this case on May 16,
· ··
·6· ·2023.
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12· ·May , 2023
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15· · · · · · · · ··________________________________
· ··
16· · · · · · · · ··Suzanne Duda, CSR-3199, RPR, CRR
· · · · · · · · · ··Notary Public, Clinton County, Michigan
17· · · · · · · · ··My commission expires:··May 6, 2025
· ··
18· ·
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25· ·

(517) 388-3128

Viridis-CRA Contested Hearings, May 15 and May 16, 2023.

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Viridis-CRA Contested Hearings, May 15 and May 16, 2023.

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Viridis v MRA, Vol.

·1· ·REMOTE APPEARANCES:

Suzanne Duda, CSR, RPR, CRR

·1· · · · · · · · · · ··INDEX OF WITNESSES

·3· ·CLAIRE PATTERSON· · · · · · · · · · · · · · · · · ·PAGE

·4· · · ··Direct Examination by Ms. Huyser· · · · · · · ··59

·5· · · ··Voir Dire Examination by Mr. Russell· · · · · ··68

·6· · · ··Direct Examnation, Cont., by Ms. Huyser· · · · ·72

·8· · · · · · · · · · ··INDEX OF EXHIBITS

·9· ·CRA EXHIBITS ADMITTED:· · · · · · · · · · · · · · ·PAGE

10· · · ··CRA Exhibit 52· · · · · · · · · · · · · · · · ··67

11· · · ··CRA Exhibit 1· · · · · · · · · · · · · · · · ··118

12· · · ··CRA Exhibit 2· · · · · · · · · · · · · · · · ··134

13· · · ··CRA Exhibit 5· · · · · · · · · · · · · · · · ··141

14· · · ··CRA Exhibit 6· · · · · · · · · · · · · · · · ··145

15· · · ··CRA Exhibit 18· · · · · · · · · · · · · · · · ·151

16· · · ··CRA Exhibit 3· · · · · · · · · · · · · · · · ··172

Suzanne Duda, CSR, RPR, CRR

·1· · · · · · · · · · · · · · · · ·Monday, May 15, 2023

·4· · · · · · · · ··JUDGE GOLDSTEIN:··We're on the record in

·5· · · ··the matter of Viridis Laboratories, LLC, and

·6· · · ··Viridis North, LLC, versus the Cannabis Regulatory

·7· · · ··Agency, consolidated Docket Numbers 21-029794,

·8· · · ··22-17866, 22-018127, 22-018128, and 22-018129.

·9· · · · · · · · ··Today is May 15th, 2023, the date set for

10· · · ··the contested case hearing in this matter.

11· · · · · · · · ··Let me get some appearances starting with

12· · · ··the Agency, please.

13· · · · · · · · ··MS. HUNT-SCULLY:··Yes.··Good morning,

14· · · ··Your Honor.··Risa Hunt-Scully from the Attorney

15· · · ··General's Office appearing on behalf of the

16· · · ··Cannabis Regulatory Agency.

17· · · · · · · · ··JUDGE GOLDSTEIN:··On behalf of Viridis,

19· · · · · · · · ··MR. RUSSELL:··Good morning, Your Honor.

20· · · ··David Russell on behalf of Viridis North and

21· · · ··Viridis Laboratories.

22· · · · · · · · ··MR. SCHUMACHER:··Good morning, Your

23· · · ··Honor.··Brandon Schumacher appearing on behalf of

24· · · ··Viridis Laboratories, LLC, and Viridis North, LLC.

25· · · · · · · · ··MS. HUYSER:··And, Your Honor, this is

Suzanne Duda, CSR, RPR, CRR

·1· · · ··Sarah Huyser.··I'm also appearing on behalf of the

·2· · · ··Cannabis Regulatory Agency.

·3· · · · · · · · ··JUDGE GOLDSTEIN:··And I see an Erika

·4· · · ··Marzorati, AG.··Is she representing or just

·6· · · · · · · · ··MS. MARZORATI:··Your Honor, this is Erika

·7· · · ··Marzorati.··I'm with Sarah Huyser and

·8· · · ··Ms. Hunt-Scully's office, and I'm just observing

·9· · · ··today from our office.

10· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··I see your name

11· · · ··there.··Thank you.

12· · · · · · · · ··MS. MARZORATI:··Thank you, Your Honor.

13· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Last week

14· · · ··the Tribunal received several motions from Viridis.

15· · · ··Let me just look here.··Looks like the first of the

16· · · ··motions was a motion to -- for leave to file an

17· · · ··amended witness list to take deposition of a

18· · · ··previously disclosed witness.··Maybe I'm getting my

19· · · ··dates wrong here for filing, but an authorized

20· · · ··recalling of CRA witnesses, and then there was a

21· · · ··partial motion for summary disposition filed it

22· · · ··looks like May 9th.··Pardon me while I look through

23· · · ··these.··And then there was a motion for -- to