Viridis-CRA Contested Hearing Transcript May 23 and May 24

Viridis v CRA, Vol.
·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
18· · · · · Respondents.
· · 6/7/23
· · · · · · · · · · · · · ·HAGARD · · · · · Case Type: MMF
19· · · · · · · · · · · · · · · · · · · · Disciplinary Hearings
· · ··
20· · · · · · · · · · · · · · · · · · · · Filing Type: Formal
· · ·· _____________________________/· · ·Complaint
21· ··
· · ··
22· · · · · · · · · · · · · · VOLUME 3
· · ··
23· ·· REMOTE PROCEEDINGS HELD IN THE ABOVE-ENTITLED MATTER
· · ··
24· ·· BEFORE ADMINISTRATIVE LAW JUDGE STEPHEN B. GOLDSTEIN
· · ··
25· · · · · · · · · TUESDAY, MAY 23, 2023, 9:14 AM
Page 429
Viridis v CRA, Vol. 3
·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)
· · · · ··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 Michigan CRA
· ··
13· ·
· ··
14· ·ALSO PRESENT:
· ··
15· · · ··Michele Glinn
· · · · ··Erika Marzorati
16· · · ··Greg Michaud
· · · · ··Lorri Rosier
17· ·
· ··
18· ·
· ··
19· ·
· ··
20· ·
· ··
21· ·
· ··
22· ·
· ··
23· ·
· ··
24· ·
· ··
25· ·REPORTED BY: Suzanne Duda, CSR-3199, RPR, CRR
Suzanne Duda, CSR, RPR, CRR

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·1· · · · · · · · · · ··INDEX OF WITNESSES
·2· ·WITNESS:· · · · · · · · · · · · · · · · · · · · · ·PAGE
·3· ·CLAIRE PATTERSON
·4· · · ··Cross-Examination, Cont., by Mr. Russell· · · ·442
·5· · · ··Voir Dire Examination by Ms. Huyser· · · · · ··591
·6· · · ··Redirect Examination by Ms. Huyser· · · · · · ·592
·7· · · ··Recross Examination by Mr. Russell· · · · · · ·619
·8· · · ··Redirect Examination, Cont., by Ms. Huyser· · ·640
·9· · · · · · · · · · ··INDEX OF EXHIBITS
10· ·VIRIDIS EXHIBITS ADMITTED:· · · · · · · · · · · · ·PAGE
11· · · ··Viridis Exhibit 14· · · · · · · · · · · · · · ·446
12· · · ··Viridis Exhibit 15· · · · · · · · · · · · · · ·484
13· · · ··Viridis Exhibit 16· · · · · · · · · · · · · · ·513
14· · · ··Viridis Exhibit 17· · · · · · · · · · · · · · ·555
15· · · ··Viridis Exhibit 18· · · · · · · · · · · · · · ·564
16· · · ··Viridis Exhibit 19· · · · · · · · · · · · · · ·568
17· · · ··Viridis Exhibit 20· · · · · · · · · · · · · · ·586
18· · · ··Viridis Exhibit 21· · · · · · · · · · · · · · ·592
19· ·
20· ·
21· ·
22· ·
23· ·
24· ·
25· ·

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·1· · · · · · · · · · · · · · · · ·Tuesday, May 23, 2023
·2· · · · · · · · · · · · · · · · ·9:14 AM
·3· · · · · · · · · · ··R E C O R D
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Good morning.··We're on
·5· · · ··the record in the matter of Viridis Laboratories,
·6· · · ··LLC, and Viridis North versus Cannabis Regulatory
·7· · · ··Agency, consolidated Docket Numbers 21-029794,
·8· · · ··22-017866, 22-018127, 22-018128, and then
·9· · · ··22-018129.
10· · · · · · · · ··Now, today's date is May 23rd, 2023.
11· · · ··It's the date set for contested -- or continued
12· · · ··hearing in the matter.
13· · · · · · · · ··Let's get some appearances starting with
14· · · ··the Cannabis Regulatory Agency, please.
15· · · · · · · · ··MS. HUNT-SCULLY:··Good morning.
16· · · ··Risa Hunt-Scully appearing on behalf of the
17· · · ··Cannabis Regulatory Agency.
18· · · · · · · · ··JUDGE GOLDSTEIN:··And on behalf of the --
19· · · · · · · · ··MS. HUYSER:··Good morning, Your Honor.
20· · · ··Sarah Huyser on behalf of the Cannabis Regulatory
21· · · ··Agency.
22· · · · · · · · ··JUDGE GOLDSTEIN:··And on behalf of
23· · · ··Viridis?
24· · · · · · · · ··MR. RUSSELL:··Good morning, Your Honor.
25· · · ··David Russell on behalf of Viridis North, LLC, and

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·1· · · ··Viridis Laboratories, LLC.
·2· · · · · · · · ··MR. SCHUMACHER:··Good morning,
·3· · · ··Your Honor.··Brandon Schumacher on behalf of
·4· · · ··Viridis Laboratories, LLC, and Viridis North, LLC.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Before we
·6· · · ··get going this morning, I want to bring to the
·7· · · ··parties' attentions -- to the parties' attention
·8· · · ··correspondence that the tribunal received late last
·9· · · ··Friday from an individual named Gus Burns from
10· · · ··MLive, a media outlet, and it was addressed to me,
11· · · ··although I'm not a party to the case, it was still
12· · · ··somewhat of an ex parte communication, regarding
13· · · ··the fact that I had -- the tribunal had closed this
14· · · ··hearing to the public and to the media.··So I am
15· · · ··going to share the email with you just so you can
16· · · ··see it.
17· · · · · · · · ··One minute here.
18· · · · · · · · ··Okay.··So I've set it, by the way, so
19· · · ··everybody can share the screen.··All right.··So I'm
20· · · ··going to share the email at this point.
21· · · · · · · · ··No, that's the wrong one.··Never mind.
22· · · · · · · · ··Anybody seeing anything?
23· · · · · · · · ··MR. RUSSELL:··Judge, it shows your Zoom
24· · · ··screen.··It shows "launch meeting."
25· · · · · · · · ··JUDGE GOLDSTEIN:··It's not working.

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·1· · · ··Let's see here.··Oh, do you see that now?
·2· · · ··All right.
·3· · · · · · · · ··MR. RUSSELL:··Yes.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Let me know when I can
·5· · · ··scroll down.
·6· · · · · · · · ··The record should reflect I'm showing the
·7· · · ··parties an email that the tribunal received Friday,
·8· · · ··May 19th, 2023, at 3:01 p.m. from Gus Burns from
·9· · · ··MLive Media Group.
10· · · · · · · · ··So is everybody done reading the article?
11· · · ··Or the email.··Excuse me.
12· · · · · · · · ··All right.··I only showed this to you
13· · · ··because I thought I should and also to explain
14· · · ··further why I've issued a protective order in this
15· · · ··case, and you also will receive an amended, second
16· · · ··amended protective order.··And primarily I issued
17· · · ··it out of -- out of -- to respond, actually, to
18· · · ··Viridis early-expressed concerns that there is a
19· · · ··potential that proprietary information might be
20· · · ··disclosed during the course of this contested case
21· · · ··hearing.··That is the primary reason I've
22· · · ··maintained the protective order.
23· · · · · · · · ··So is that still Viridis's position that
24· · · ··the protective order should remain?
25· · · · · · · · ··MR. RUSSELL:··Yes, Judge.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··The issue of --
·2· · · ··Mr. Burns raises the issue of public interest and
·3· · · ··public safety.··I'm just throwing this out there,
·4· · · ··okay?··I can lift the protective order.··I think I
·5· · · ··have tailored the amended protective order so that
·6· · · ··is only seals information that's -- was very --
·7· · · ··discussed in detail during the first hearing, which
·8· · · ··was Viridis's methods, procedures of testing
·9· · · ··potency.··Okay?··Ms. Patterson testified in detail
10· · · ··about that and what the Agency found to be
11· · · ··inappropriate about it.··So I'm interpreting that
12· · · ··to be your proprietary or likely proprietary
13· · · ··information.
14· · · · · · · · ··Am I correct, Counsel?
16· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So in the second
17· · · ··amended protective order that you will receive -- I
18· · · ··don't know if you've already received it or not --
19· · · ··but you will see that -- and that is in direct
20· · · ··response to FOIA requests we're getting -- the
21· · · ··hearing recordings and hearing records.··So I just
22· · · ··wanted to put this out there that this media outlet
23· · · ··reached out to the tribunal.··Okay?
24· · · · · · · · ··Any comment from the Agency, Ms. Huyser
25· · · ··or Ms. Hunt-Scully?

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·1· · · · · · · · ··MS. HUNT-SCULLY:··No, Your Honor.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Any further comment
·3· · · ··from Viridis?
·4· · · · · · · · ··MR. RUSSELL:··Judge, the only -- the only
·5· · · ··comment I would make, we don't have a specific
·6· · · ··objection to it being -- anything being open to the
·7· · · ··public, I want to make that very clear, just
·8· · · ··specifically to the proprietary methods that you
·9· · · ··did reference we think that the order is
10· · · ··appropriate.··But other than that we don't have any
11· · · ··issue with, you know, the media being aware of
12· · · ··what's going on or having access, just to the
13· · · ··proprietary information, that's our only concern.
14· · · · · · · · ··JUDGE GOLDSTEIN:··And that's -- that's
15· · · ··the issue.··Okay?··You know, when a FOIA request
16· · · ··comes in for the hearing recording it's a little
17· · · ··difficult to parse out the recording itself to omit
18· · · ··the discussion of your methods as was discussed by
19· · · ··Ms. Patterson in the last hearings.
20· · · · · · · · ··So are the parties -- you have your own
21· · · ··court reporter here.··I assume you're going to get
22· · · ··transcripts, Counsel from Viridis?
24· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Please make
25· · · ··sure that as they are produced we get copies of

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·1· · · ··them.
·2· · · · · · · · ··MR. RUSSELL:··They have been produced for
·3· · · ··the first day, Judge.··Would you like a copy sent
·4· · · ··to your -- to the tribunal?
·5· · · · · · · · ··JUDGE GOLDSTEIN:··If they are already
·6· · · ··produced, yeah, you can just submit them to the
·7· · · ··tribunal.··That would be fine.··We get it through
·8· · · ··the email.··Is the email good?··It usually works.
·9· · · · · · · · ··So very good.··I just wanted to share
10· · · ··that with the parties.
11· · · · · · · · ··MR. RUSSELL:··I guess one thing on the --
12· · · ··while we're talking about the transcripts
13· · · ··themselves, and I guess I'll ask Ms. Duda to speak
14· · · ··to this, but typically I don't just share -- I will
15· · · ··with the tribunal, that's different, but with
16· · · ··opposing counsel there's -- usually they order
17· · · ··transcripts if they want those because they're --
18· · · ··usually Ms. Duda will have a cost associated with
19· · · ··that.
20· · · · · · · · ··JUDGE GOLDSTEIN:··The reason I'm bringing
21· · · ··up transcripts, it's a lot easier to redact
22· · · ··transcripts than it is on a recording.
23· · · · · · · · ··MR. RUSSELL:··Right.··Someone else has a
24· · · ··mic on or something.··I'm getting feedback.··I
25· · · ··can't hear you.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Ms. Duda doesn't have
·2· · · ··her -- Ms. Hunt-Scully, do you have your . . .
·3· · · · · · · · ··MR. RUSSELL:··Okay.··I think that --
·4· · · ··yeah, that's better.
·5· · · · · · · · ··Judge, the only point I was making --
·6· · · ··Ms. Duda may want to address this -- is typically
·7· · · ··when opposing Counsel wants to order the transcript
·8· · · ··I believe there's some charge for that.··So I don't
·9· · · ··want to circumvent whatever Ms. Duda is doing.
10· · · ··We'll obviously pay our fee for the transcripts.
11· · · · · · · · ··Ms. Duda, do you want to speak to that?
12· · · · · · · · ··COURT REPORTER:··Ms. Hunt-Scully, did you
13· · · ··want to . . .
14· · · · · · · · ··Ms. Hunt-Scully has ordered the
15· · · ··transcript as well.··Both days last week have been
16· · · ··sent out.
17· · · · · · · · ··JUDGE GOLDSTEIN:··Oh.
18· · · · · · · · ··COURT REPORTER:··I guess I would ask, you
19· · · ··know, as far as my not being the official record,
20· · · ··is that still the case then with transcripts being
21· · · ··provided to all parties?
22· · · · · · · · ··JUDGE GOLDSTEIN:··That is correct.
23· · · · · · · · ··Ms. Hunt-Scully, you've actually resolved
24· · · ··the problem because I just started thinking about
25· · · ··that, Ms. Duda, what you brought up since you're

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·1· · · ··not the official record.
·2· · · · · · · · ··The official record, Ms. Hunt-Scully,
·3· · · ··is -- because we're getting FOIA requests, okay, we
·4· · · ··have to produce the transcript or the recording,
·5· · · ··one of the two.
·6· · · · · · · · ··So if you're already ordering, make sure
·7· · · ··we get a copy of it.··Okay?··And you can send those
·8· · · ··by email.··I think that's how you can do that.
·9· · · ··Okay?··Thank you very much.
10· · · · · · · · ··MR. RUSSELL:··Yeah, we'll do that, Judge.
11· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Thank you.
12· · · · · · · · ··COURT REPORTER:··I guess I should ask,
13· · · ··Your Honor, will my transcript possibly be provided
14· · · ··to the media?
15· · · · · · · · ··JUDGE GOLDSTEIN:··No, you're actually not
16· · · ··the official record.··It's not part of our record
17· · · ··so . . .
18· · · · · · · · ··COURT REPORTER:··Okay.··Thank you.
19· · · · · · · · ··MR. RUSSELL:··Judge, can I just follow up
20· · · ··on that?
21· · · · · · · · ··If we send it to you via that email
22· · · ··wouldn't that be -- wouldn't it -- if someone sends
23· · · ··a FOIA wouldn't that become --
24· · · · · · · · ··JUDGE GOLDSTEIN:··If it comes into our
25· · · ··possession, then we may have to disclose it.··But

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·1· · · ··it should be identical to the one
·2· · · ··Ms. Hunt-Scully -- and we can redact both of
·3· · · ··them -- but Ms. Hunt-Scully's -- the one you're
·4· · · ··ordering, Ms. Hunt-Scully, is from the recording;
·5· · · ··correct?
·6· · · · · · · · ··MS. HUNT-SCULLY:··Yes, from Ms. Duda.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So that's the
·8· · · ··official transcript.
·9· · · · · · · · ··COURT REPORTER:··I don't know, Judge, if
10· · · ··you heard her.··She ordered my transcript, not the
11· · · ··recording.
12· · · · · · · · ··MS. HUNT-SCULLY:··Right.··No, I'm not --
13· · · ··I haven't asked for the audio and I don't intend to
14· · · ··right now.··I just plan on relying on Ms. Duda's
15· · · ··transcript whatever, you know, worth that we want
16· · · ··to use it understanding it's not the official.
17· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Well, I
18· · · ··will -- there is a procedure for adopting a backup
19· · · ··transcript as an official part of the proceeding,
20· · · ··but I'll have to talk to the chief judge to see how
21· · · ··we're going to handle that.··I just wanted to
22· · · ··inquire about the transcript issue.
23· · · · · · · · ··MR. RUSSELL:··Does Ms. Duda have an
24· · · ··objection to that being turned over to the
25· · · ··tribunal?

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·1· · · · · · · · ··COURT REPORTER:··No, I do not.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Anything else on this?
·3· · · · · · · · ··MR. RUSSELL:··Not on this, Judge.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Any
·5· · · ··preliminary matters before we get started for the
·6· · · ··Agency?
·7· · · · · · · · ··MS. HUYSER:··No, Your Honor.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··From Viridis?
·9· · · · · · · · ··MR. RUSSELL:··Yeah.··Judge, the only
10· · · ··preliminary thing is I know last time there was
11· · · ··some exhibits that I believe the tribunal didn't
12· · · ··think that they had, so we had sent those to the
13· · · ··tribunal along with the AG's office which hopefully
14· · · ··they have all received.··But I'm told from my
15· · · ··colleagues that they can tell when the exhibits
16· · · ··have been downloaded and they haven't been
17· · · ··downloaded by the tribunal, so I want to make sure
18· · · ··that you have those.··I don't want to have that
19· · · ··issue, if possible.
20· · · · · · · · ··Does that make sense?
21· · · · · · · · ··JUDGE GOLDSTEIN:··That makes sense.··So
22· · · ··let's get going on the hearing, and I will be
23· · · ··looking for those.··If I have to send an email I
24· · · ··will.
25· · · · · · · · ··Or were you going to start off with those

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·1· · · ··exhibits, Counsel?
·2· · · · · · · · ··MR. RUSSELL:··No, I wasn't sure if you
·3· · · ··were going to swear in the witness again or we're
·4· · · ··just continuing.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··No, I was just waiting
·6· · · ··for any other preliminary matters.
·7· · · · · · · · ··MR. RUSSELL:··Oh, I'm sorry.··That's all
·8· · · ··I had, Judge.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··Very good.
10· · · · · · · · ··Yeah, when we left off at the last
11· · · ··hearing, Ms. Patterson, you were still on the
12· · · ··stand.··Because it is a new hearing day I'm going
13· · · ··to re-swear you.··Okay?
14· · · · · · · · ··Would you raise your right hand.··Do you
15· · · ··solemnly swear or affirm to tell the truth, the
16· · · ··whole truth, and nothing but the truth?
17· · · · · · · · ··MS. PATTERSON:··I do.
18· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you.
19· · · · · · · · ··Could you state your name for the record
20· · · ··again.··You don't need to spell it again.
21· · · · · · · · ··THE WITNESS:··Claire Patterson.
23· · · · · · · · ··Counsel, go ahead.
24· ·
25· ·

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·1· · · · · · · ··CROSS-EXAMINATION, CONTINUING
·2· ·BY MR. RUSSELL:
·3· ·Q· ··Good morning, Ms. Patterson.··Last time we were
·4· · · ··here at the end of your testimony you may recall we
·5· · · ··were starting to talk about an investigation that
·6· · · ··began I believe in January 2021 subsequent to the
·7· · · ··December of 2020 semi-annual inspections.··Do you
·8· · · ··recall that?
·9· ·A· ··Yes, sir.
10· ·Q· ··Okay.··And I believe you testified you were aware
11· · · ··that an investigative report was drafted by a
12· · · ··Noah Rosenzweig in March of 2021.··Is that correct?
13· ·A· ··I'm not sure when the drafting began.··I believe
14· · · ··that is when it was approved.
15· ·Q· ··All right.··And would you have had any part in
16· · · ··creating the investigative report?
17· ·A· ··At that point in time I did not.··And I was not
18· · · ··responsible for reviewing reports at that time
19· · · ··either I do not believe.
20· ·Q· ··Okay.··Do you know if you did review the report?
21· ·A· ··I did eventually review the report, but I was not
22· · · ··the final manager for sign-off.
23· ·Q· ··Okay.··And I'm going to show you that since you did
24· · · ··review it.··That's previously been marked as
25· · · ··Exhibit 11, but that will be, I guess, Exhibit 14

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·1· · · ··now if we admit it.
·2· · · · · · · · ··So we'll scroll through that so that --
·3· · · ··see if you recognize the document.
·4· ·A· ··Thank you.
·5· ·Q· ··Ms. Patterson, do you recognize that document?
·6· ·A· ··Yes, I do.
·7· ·Q· ··And is that the investigative report that you just
·8· · · ··testified that you reviewed?
·9· ·A· ··Yes, sir.
10· ·Q· ··Okay.··And would that be an accurate depiction of
11· · · ··the I believe it's the March 10th, '21,
12· · · ··investigative report?
13· ·A· ··Yes, sir.
14· · · · · · · · ··MR. RUSSELL:··Okay.··Judge, I would move
15· · · ··to admit this investigative report as Exhibit 14.
16· · · · · · · · ··MS. HUYSER:··No objection.
17· ·Q· ··(MR. RUSSELL) So at the top of the investigative
18· · · ··report it indicates that the investigator is
19· · · ··Rosenzweig.··That would be one of the LSSs; is that
20· · · ··correct?
21· ·A· ··That is correct.
22· ·Q· ··Okay.··And then Donald Christy, who is that?
23· ·A· ··That was at the time the manager of the operations
24· · · ··support section here at the Cannabis Regulatory
25· · · ··Agency.

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·1· · · · · · · · ··MR. RUSSELL:··Okay.··Judge, was that
·2· · · ··admitted into evidence?
·3· · · · · · · · ··MS. HUYSER:··I don't know if he's on.
·4· · · ··I'm not seeing him.
·5· · · · · · · · ··MR. RUSSELL:··Okay.··That's what Brandon
·6· · · ··just said too.··So maybe we should wait a second.
·7· · · · · · · · ··MS. HUYSER:··Uh-huh.
·8· · · · · · · · ··MR. RUSSELL:··Do you want to take a
·9· · · ··10-minute break and see if the Judge comes back on?
10· · · · · · · · ··MS. HUYSER:··Yeah, I don't see why not.
11· · · · · · · · ··MR. RUSSELL:··Okay.
12· · · · · · · · ··(Video conferencing technical issues;
13· · · · · · · · ··break taken from 9:38 AM to 9:44 AM.)
14· · · · · · · · ··MR. RUSSELL:··Judge, I'm not sure where
15· · · ··we left off last time.··I believe the witness --
16· · · · · · · · ··JUDGE GOLDSTEIN:··Just let me reintroduce
17· · · ··the hearing here.
18· · · · · · · · ··MR. RUSSELL:··Sorry.
19· · · · · · · · ··JUDGE GOLDSTEIN:··In the matter of
20· · · ··Viridis, LLC, and Viridis North versus the Cannabis
21· · · ··Regulatory Agency, consolidated Docket Numbers
22· · · ··21-029794, et al.
23· · · · · · · · ··The record should reflect we've had some
24· · · ··technical difficulties with the Zoom.··Several
25· · · ··people have been booted off already.

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·1· · · · · · · · ··So at this point, Counsel, I don't know
·2· · · ··where you left off either.··I think you were
·3· · · ··talking about the investigation report.··You were
·4· · · ··having her go through it.··That's when I got
·5· · · ··knocked off the first time.··So . . .
·6· · · · · · · · ··MR. RUSSELL:··Yes, Judge, that's what I
·7· · · ··was just going to confirm.··I believe the witness
·8· · · ··did testify that she recognized the report and it
·9· · · ··was an accurate depiction of the report, and I had
10· · · ··moved to have this admitted as Exhibit 14.
11· · · · · · · · ··I can ask that again.
12· ·Q· ··(MR. RUSSELL) Ms. Patterson, do you recognize this
13· · · ··report?
14· ·A· ··Yes, sir.
15· ·Q· ··Okay.··And --
16· · · · · · · · ··MR. SCHUMACHER:··We lost the Judge again.
17· · · · · · · · ··(Video conferencing technical issues;
18· · · · · · · · ··break taken from 9:45 AM to 9:55 AM.)
19· · · · · · · · ··JUDGE GOLDSTEIN:··Back on the record in
20· · · ··the matter of Viridis Labs, LLC, and Viridis North
21· · · ··versus Cannabis Regulatory Agency, consolidated
22· · · ··Docket Numbers 21-029794, et al.
23· · · · · · · · ··Counsel, my apologies for the
24· · · ··obstructions with the technology failure.··I think
25· · · ··you were sharing a document again?

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·1· · · · · · · · ··MR. RUSSELL:··Yes, Your Honor.··I believe
·2· · · ··I asked to have this admitted as Exhibit 14.··I'm
·3· · · ··not sure if we got that far or not.
·4· · · · · · · · ··MS. HUYSER:··And we have no objection,
·5· · · ··Your Honor.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··I'm showing --
·7· · · ··well, wait a minute.··The ones that you submitted
·8· · · ··after the hearing, were those -- yeah, up to 14.
·9· · · · · · · · ··So this would be 14.··Is that correct,
10· · · ··Counsel?
11· · · · · · · · ··MR. RUSSELL:··This would have been I
12· · · ··believe it was 11 in the exhibits that were
13· · · ··submitted to the tribunal originally, Judge.
14· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··You were
15· · · ··offering this as 14; correct?
16· · · · · · · · ··MR. RUSSELL:··Correct.
17· · · · · · · · ··JUDGE GOLDSTEIN:··Viridis Exhibit 14 is
18· · · ··admitted.
19· · · · · · · · ··(Viridis Exhibit 14 is admitted.)
20· · · · · · · · ··JUDGE GOLDSTEIN:··And, by the way,
21· · · ··Counsel, I did check with staff and they said they
22· · · ··did not get any exhibits last week from you.
23· · · · · · · · ··MR. RUSSELL:··I'll follow up on that.··I
24· · · ··do know that the email did go out.··I believe it's
25· · · ··the correct email address.··They were also sent to

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·1· · · ··Ms. Hunt-Scully and Ms. Huyser as well.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··I apologize.··You might
·3· · · ··want to mark them in all caps.
·4· · · · · · · · ··MR. RUSSELL:··I'll make sure they're
·5· · · ··resent today with a copy to the AG's Office.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Thank you.
·7· · · · · · · · ··All right.··Go ahead, Counsel.
·8· ·Q· ··(MR. RUSSELL) Ms. Patterson, we started to ask you
·9· · · ··about this investigation report that's dated
10· · · ··March 10th, 2021, and, again, I believe you
11· · · ··testified that the investigation that led to this
12· · · ··report being written began in January of 2021.··Is
13· · · ··that correct?
15· ·Q· ··And, Ms. Patterson, if you look at the bottom of
16· · · ··the first page there it talks about on
17· · · ··December 2nd, 2020, the Marijuana Regulatory Agency
18· · · ··flagged results from Viridis North, LLC, for high
19· · · ··potency and requested audits of potency.
20· · · · · · · · ··Do you see that?
21· ·A· ··Yes, sir.
22· ·Q· ··Okay.··Now, you had testified one of the earlier
23· · · ··days that as part of the email chain that you had
24· · · ··with Dr. Michele Glinn that there was numerous
25· · · ··flagged potency results.··Do you recall that?

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·1· ·A· ··As part of the high-potency audit, yes, sir, that
·2· · · ··is correct.
·3· ·Q· ··Okay.··And so that would have been back in early
·4· · · ··November 2020; is that correct?
·5· ·A· ··Yes, sir, that is correct.
·6· ·Q· ··Okay.··And I believe, if we go to the end of
·7· · · ··this -- which we don't need to do right this
·8· · · ··minute -- but I believe that there's an email from
·9· · · ··you to Dr. Glinn that's part of the attachments to
10· · · ··support this investigative report.
11· ·A· ··That may be the case.
12· · · · · · · · ··MR. RUSSELL:··Well, let's confirm it
13· · · ··because I want to make sure I'm right about that.
14· · · · · · · · ··Can you go to 6 of 20?
15· · · · · · · · ··THE WITNESS:··Yes, sir, this would be an
16· · · ··email from the safety compliance facility inbox
17· · · ··with that -- well, at the MRA at that time --
18· · · ··requesting an analysis of potency for the
19· · · ··associated samples in this email thread.
20· ·Q· ··(MR. RUSSELL) Okay.··So I just want to make sure
21· · · ··that we're -- I'm understanding what is being
22· · · ··discussed here.··When it says December 2nd, 2020,
23· · · ··do you know why that is that there's a later date
24· · · ··on that for flagged results on that first page?
25· ·A· ··I'm not seeing exactly what it is that you're

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·1· · · ··talking about.
·2· ·Q· ··So under the summary there on the first page it
·3· · · ··says "On 12/2/2020 the Marijuana Regulatory Agency,
·4· · · ··MRA, flagged testing results."
·5· ·A· ··Oh, that is likely due to additional testing
·6· · · ··results that were flagged.··I would imagine, but I
·7· · · ··didn't write this report, so I can't speak to that
·8· · · ··directly.
·9· ·Q· ··Okay.··And Mr. Rosenzweig wouldn't have reached out
10· · · ··to you to ask you about the high-potency email that
11· · · ··he attached to this?
12· ·A· ··No, he would have had access to that on his own.
13· ·Q· ··So you didn't have any discussion with him about
14· · · ··that?
15· ·A· ··Not that I recall.
16· ·Q· ··And then it goes on in that first page to talk
17· · · ··about the December 22nd, 2020, semi-annual
18· · · ··inspection.··Do you see that on the first page?
19· ·A· ··Yes, sir.
20· ·Q· ··And then it goes on to the second page to discuss
21· · · ··that Viridis North, LLC, was not adhering to their
22· · · ··approved standing operating procedure for analysis,
23· · · ··and it lists I believe three rules that
24· · · ··Mr. Rosenzweig is identifying that they're in
25· · · ··violation of; is that correct?

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·1· ·A· ··Yes, sir.
·2· ·Q· ··Okay.··So am I also correct that everything that's
·3· · · ··set forth in what's called this complaint and this
·4· · · ··investigative report as not being compliant are all
·5· · · ··things relating to the high-potency flagged Metrc
·6· · · ··data from November 2020 through the semi-annual
·7· · · ··inspection on December 22, 2020?··Is that correct?
·8· ·A· ··Yes.··This is an ongoing period of noncompliance
·9· · · ··where the Agency was attempting to elucidate what
10· · · ··exactly was happening at the laboratories.··So
11· · · ··this, I believe, is a comprehensive investigation
12· · · ··report detailing those interactions and those --
13· · · ··results of those interactions.
14· ·Q· ··So the December 22nd, 2020, semi -- it was called a
15· · · ··semi-annual inspection, but really it appears that
16· · · ··it was part of an investigation; is that correct?
17· ·A· ··No, sir, it was a semi-annual inspection.··It was
18· · · ··additionally an audit which is typically performed
19· · · ··in concert with a semi-annual inspection.
20· ·Q· ··Okay.··And, again, you testified to this last time
21· · · ··but I just want to be clear that this semi-annual
22· · · ··inspection was the same semi-annual inspection that
23· · · ··was passed by both of the two Viridis laboratories;
24· · · ··correct?
25· ·A· ··Yes, sir.··And again I will reiterate that

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·1· · · ··semi-annual inspections and investigations do
·2· · · ··follow different pathways.
·3· ·Q· ··So the first thing I want to ask you about is on
·4· · · ··page 2 where it talks about -- and this is the
·5· · · ··bottom paragraph -- specifically -- and it looks
·6· · · ··like there was a recording, and so there's some
·7· · · ··quotes from Mr. LaFramboise where he's talking
·8· · · ··about the use of alumina beads.··Do you see that?
·9· ·A· ··Yes, sir.
10· ·Q· ··Okay.··And then in the report it states "Because
11· · · ··they're using alumina beads, this is a significant
12· · · ··deviation from the manufacturer method.··Alumina
13· · · ··beads are ceramic beads made of aluminum oxide.
14· · · ··However, the manufacturer's instructions specify
15· · · ··grinding balls of stainless steel."
16· ·A· ··That's correct.
17· ·Q· ··So is that correct?
18· ·A· ··Yes, sir, that is what it says.
19· ·Q· ··Okay.··And isn't it true that you testified last
20· · · ··week that the January SOP, which I believe you
21· · · ··testified was approved, required the use of ceramic
22· · · ··balls?
23· ·A· ··I don't believe I testified to that specifically.
24· · · ··I'd have to refer to the method.
25· ·Q· ··Okay.··Do you -- do you have any reason to believe

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·1· · · ··that's incorrect that the SOP validation
·2· · · ··specifically required the use of these alumina
·3· · · ··balls?
·4· ·A· ··I would have to read it specifically to confirm
·5· · · ··that information, but otherwise I do not have any
·6· · · ··reason to believe that's not the truth.
·7· ·Q· ··Okay.··So to the extent that is the truth -- and we
·8· · · ··will see testimony to that during this hearing --
·9· · · ··do you know why, then, Mr. Rosenzweig would
10· · · ··identify this as a violation of the rules, not
11· · · ··complying with the rules?
12· ·A· ··Well, I did not write this, so I can't speak to
13· · · ··what Dr. Rosenzweig was referring to.
14· ·Q· ··But you would agree with me that these
15· · · ··investigation reports, it's important that they're
16· · · ··accurate; correct?
17· ·A· ··Absolutely.
18· ·Q· ··Okay.··And so to the extent that that's not
19· · · ··accurate, that allegation, that would be
20· · · ··problematic, wouldn't you agree?
21· ·A· ··Again, I can't speak to whether or not it's
22· · · ··accurate.
23· ·Q· ··To the extent the January 2020 validation is
24· · · ··validated with the use of these ceramic balls, and
25· · · ··to the extent that that's being identified as a

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·1· · · ··violation in this investigative report, as a
·2· · · ··scientific manager over Dr. Rosenzweig would you
·3· · · ··consider that to be problematic?
·4· ·A· ··Again, I can't speak to this.··I didn't write it
·5· · · ··nor was I the reviewing manager who signed off on
·6· · · ··this.
·7· ·Q· ··Now, the second and third instances that are talked
·8· · · ··about in the investigative report, number one --
·9· · · ··the second one relates to the scraping of the
10· · · ··beads; is that correct?
11· ·A· ··I believe so.··That was certainly in there.··I'm
12· · · ··not sure if it was the second one or not.
13· ·Q· ··Okay.··And would you agree with me that in the
14· · · ··December 3rd, 2020, SOP that you received from
15· · · ··Dr. Michele Glinn this was the procedure that was
16· · · ··set forth?
17· ·A· ··In the nonapproved SOP that we received, yes, this
18· · · ··was the procedure that was set forth.··However,
19· · · ··it's important to remember that that SOP was never
20· · · ··approved.
21· ·Q· ··Okay.··And I understand that's your position, but
22· · · ··you did pass the two laboratories at the
23· · · ··semi-annual inspection while using that SOP and
24· · · ··never told them that they were not approved;
25· · · ··correct?

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·1· ·A· ··I was having conversations via email with Dr. Glinn
·2· · · ··at that time attempting to gain more information
·3· · · ··about the methods that they were using in the
·4· · · ··laboratory.
·5· · · · · · · · ··To reiterate, this method was never
·6· · · ··approved.··The semi-annual inspection passed
·7· · · ··because the laboratory themselves did have a method
·8· · · ··on file, and that was the method that initially was
·9· · · ··submitted in January of 2020 and then was updated
10· · · ··to clarify the word "homogenize" or
11· · · ··"homogenization" in May of 2020.
12· · · · · · · · ··So the reason that they passed the
13· · · ··semi-annual inspection is because they did, in
14· · · ··fact, have a method on file with the Agency.
15· · · · · · · · ··Now, they were not using that method.
16· · · ··They were using a December method that they had
17· · · ··submitted through the inappropriate channels.
18· ·Q· ··And so this investigative report was done in March
19· · · ··of 2021 that you stated -- or you testified that
20· · · ··the investigation started in January of 2021 when,
21· · · ··I mean, in reality it started in November of 2020
22· · · ··based on the flagged high potency.··And through
23· · · ··that time, though, it is true that you never made
24· · · ··either of the Viridis laboratories aware that there
25· · · ··was any investigation taking place.··I believe that

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·1· · · ··was your previous testimony in deposition.
·2· · · ··Correct?
·3· ·A· ··That is not exactly what I said.··I did speak --
·4· · · ··well, again, virtually I will reiterate, through
·5· · · ··email with Dr. Glinn and was trying to gain more
·6· · · ··information about what exactly was going on in the
·7· · · ··laboratory.··Because ultimately what was happening
·8· · · ··is we were getting conflicting information from
·9· · · ··Dr. Glinn.··We were getting SOPs that didn't quite
10· · · ··match with the data that she had sent us.··The data
11· · · ··that I will remind you was not a validation.··And
12· · · ··additionally, the SOP didn't match with what they
13· · · ··were calling their I believe it was research review
14· · · ··or research summary, something to that effect.
15· · · · · · · · ··So ultimately I don't think it was an
16· · · ··investigation.··I don't believe it was an
17· · · ··investigation at that time, it was an attempt for
18· · · ··the Agency to learn more information in hopes that
19· · · ··the laboratory would be forthcoming and honest with
20· · · ··what it was that they were doing in the laboratory
21· · · ··space.
22· ·Q· ··You continuously state that you're looking for more
23· · · ··information, you're not sure what they're doing.
24· · · ··I'm having trouble understanding your testimony.
25· · · · · · · · ··You would agree that your laboratory

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·1· · · ··scientists on December 22nd, 2020, not only watched
·2· · · ··the potency method being done, the same one that's
·3· · · ··in this SOP that you're now trying to disavow, they
·4· · · ··didn't just watch it but they recorded it.··There's
·5· · · ··an actual recording of what Viridis is doing.
·6· · · · · · · · ··Am I wrong about that?
·7· ·A· ··Oh, there absolutely is a recording.··And I will
·8· · · ··remind you too, this was during the height of the
·9· · · ··COVID-19 pandemic, so we were incredibly limited in
10· · · ··our ability to actually visually witness what it
11· · · ··was that the laboratory was doing.
12· · · · · · · · ··So when I say that we were attempting to
13· · · ··gain more information, we would hope that having
14· · · ··these even virtual conversations with the
15· · · ··laboratory that they would be honest with us about
16· · · ··the practices that they were implementing in the
17· · · ··laboratory space.··Unfortunately, it wasn't until
18· · · ··December 22nd that we were able to witness them
19· · · ··using an SOP that was not approved by the Agency.
20· · · ··And, as I stated previously, the investigation
21· · · ··began in January of 2021 at which point we had
22· · · ··officially determined that the laboratory was using
23· · · ··in practice a method that was not approved by the
24· · · ··Agency.
25· ·Q· ··You've never identified anything that either of the

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·1· · · ··Viridis laboratories were not honest about.··That's
·2· · · ··the first time I've heard that from you.··So why
·3· · · ··don't you tell me exactly what either of the
·4· · · ··Viridis laboratories were not honest about.
·5· ·A· ··Absolutely.··So when we were sent this method that
·6· · · ··was used here in December of 2022, what the method
·7· · · ··had stated that they were doing was scraping
·8· · · ··trichomes off of the grinding media and putting
·9· · · ··them back into the homogenized flower material.
10· · · ··What was interesting is the data that Michele had
11· · · ··sent me actually demonstrated that they were using
12· · · ··those grinding media in the extraction vials which
13· · · ··is what we ended up seeing later in the June of
14· · · ··2021 method.
15· · · · · · · · ··So the data that she provided us did not
16· · · ··match with what we were seeing in the SOP.··So the
17· · · ··fact that there was that disparity there between
18· · · ··the SOP, what we saw Michael do and what we
19· · · ··actually saw in the data that she submitted as an
20· · · ··attempt at a validation was concerning.··And I
21· · · ··believe that is not truthful.
22· ·Q· ··So really what was in what she sent you was that
23· · · ··they do either, that they scrape the beads or it's
24· · · ··put in the vial.
25· · · · · · · · ··So actually what Dr. Glinn sent to you

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·1· · · ··was a hundred percent accurate, you're just
·2· · · ··claiming now to disavow that that SOP was approved.
·3· · · ··There was nothing dishonest that was sent to you.
·4· · · ··She sent you exactly what they were doing and then
·5· · · ··you not only watched it, you recorded it and then
·6· · · ··opened an investigation about it without ever
·7· · · ··telling the lab.··Is that correct?
·8· ·A· ··Actually what the SOP stated is that if a
·9· · · ··noncompliant sample only contained a very small
10· · · ··amount, for example, one flower, that they would do
11· · · ··that.··There is absolutely no reason that a
12· · · ··laboratory should be treating samples any
13· · · ··differently from one another, whether they're
14· · · ··compliant or noncompliant samples.
15· · · · · · · · ··Additionally, the use of the word
16· · · ··"noncompliance" indicates very clearly that the
17· · · ··sample is not used for compliance testing.··So I do
18· · · ··not believe that was an accurate depiction
19· · · ··whatsoever.··Especially considering that the
20· · · ··weights that they designated were supposed to be in
21· · · ··excess of that 1 gram where they're grinding up,
22· · · ··you know, 12, 16, 32 grams within an amber vial.
23· · · ··So I do not believe that was consistent anyway.
24· ·Q· ··Dr. Glinn in the email told you that the labs use
25· · · ··methanol; correct?

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·1· ·A· ··I don't recall.
·2· ·Q· ··Okay.··Well, the evidence has shown, the emails
·3· · · ··back and forth -- and I guess we can go back into
·4· · · ··those if need be -- that the laboratories were
·5· · · ··using methanol.
·6· · · · · · · · ··Are you denying that?··I mean, you seem
·7· · · ··to remember very clearly what was sent to you.
·8· ·A· ··I don't disagree that it was methanol.··I'm not
·9· · · ··going to agree to something that I can't see,
10· · · ··though.··Yes, I do remember details of this case
11· · · ··certainly.
12· ·Q· ··Okay.··So you would agree with me that Dr. Glinn
13· · · ··specifically told you that methanol may be used?
14· ·A· ··She may have.
15· ·Q· ··So I'm still not hearing anything from you that
16· · · ··either of the Viridis labs told you that was not
17· · · ··honest.
18· · · · · · · · ··I get your testimony is you believe now
19· · · ··that you're not approving this SOP or you're
20· · · ··disavowing this SOP, but what was it that they told
21· · · ··you that was dishonest?··They told you exactly what
22· · · ··they were doing, you watched it, you recorded it,
23· · · ··and then you opened up an investigation, wrote an
24· · · ··investigative report, and we're about to get to a
25· · · ··formal complaint that was drafted all while never

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·1· · · ··letting either one of these laboratories know that
·2· · · ··you're conducting this investigation.··Is that
·3· · · ··right?
·4· · · · · · · · ··MS. HUNT-SCULLY:··Judge, I'm so sorry to
·5· · · ··interrupt, but I believe Ms. Huyser got booted off.
·6· · · · · · · · ··MR. RUSSELL:··Can you take this down
·7· · · ··really quick?··Sorry.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··You know, I think that
·9· · · ··anybody on the State VPN, I just got -- there is an
10· · · ··email going around from the IT department that
11· · · ··multiple agencies are experiencing network
12· · · ··problems, and I think those problems might be
13· · · ··interfering with the Zoom because I haven't had any
14· · · ··problems sitting here since I've been out of
15· · · ··network, so . . .
16· · · · · · · · ··She's coming back in now.··There she is.
17· · · · · · · · ··Did you get booted off too?
18· · · · · · · · ··MS. HUNT-SCULLY:··I did.··Did everybody?
19· · · · · · · · ··JUDGE GOLDSTEIN:··No.··Are you on the
20· · · ··network?
21· · · · · · · · ··MS. HUYSER:··No, I'm working from home.
22· · · ··I mean, I'm on the VPN, but --
23· · · · · · · · ··JUDGE GOLDSTEIN:··Try getting off that.
24· · · ··That's what I was -- was problematic for me too.
25· · · ··And so far everything's been good since I've been

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·1· · · ··off that.··I don't know if you got the email about
·2· · · ··various agencies having slowness issues or
·3· · · ··something like that, so . . .
·4· · · · · · · · ··All right, Counsel, go ahead.··Sorry for
·5· · · ··the interruption again.
·6· · · · · · · · ··MR. RUSSELL:··Sue, are you able to read
·7· · · ··back the last question?··I apologize.
·8· · · · · · · · ··(The record was read back by the court
·9· · · · · · · · ··reporter as follows:
10· · · · · · · · ··"QUESTION:··So I'm still not hearing
11· · · · · · · · ··anything from you that either of the
12· · · · · · · · ··Viridis labs told you that was not
13· · · · · · · · ··honest.
14· · · · · · · · ··"I get your testimony is you believe now
15· · · · · · · · ··that you're not approving this SOP or
16· · · · · · · · ··you're disavowing this SOP, but what was
17· · · · · · · · ··it that they told you that was dishonest?
18· · · · · · · · · ·They told you exactly what they were
19· · · · · · · · ··doing, you watched it, you recorded it,
20· · · · · · · · ··and then you opened up an investigation,
21· · · · · · · · ··wrote an investigative report, and we're
22· · · · · · · · ··about to get to a formal complaint that
23· · · · · · · · ··was drafted all while never letting
24· · · · · · · · ··either one of these laboratories know
25· · · · · · · · ··that you're conducting this

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·1· · · · · · · · ··investigation.··Is that right?")
·2· · · · · · · · ··MR. RUSSELL:··So I believe I was waiting
·3· · · ··for an answer to that question.
·4· · · · · · · · ··THE WITNESS:··Yes, sir.··So ultimately
·5· · · ··the fact that there was so much ambiguity from what
·6· · · ··was submitted and what was actually approved, I
·7· · · ··felt that it was necessary, as did my management,
·8· · · ··to view what Viridis was doing in practice.
·9· · · · · · · · ··And, again, I will reiterate that the
10· · · ··reason that the investigation started after the
11· · · ··semi-annual inspection is because that was the
12· · · ··first time that we witnessed the laboratory in
13· · · ··practice using a method that was not approved by
14· · · ··the Agency.··And I'm not disavowing it.··It truly
15· · · ··was not approved.
16· ·Q· ··(MR. RUSSELL) And if you fast-forward to June 2021
17· · · ··where there again is a semi-annual inspection, your
18· · · ··lab scientists again went on site, again viewed
19· · · ··both laboratories doing this method and approved
20· · · ··them both at that semi-annual inspection as well;
21· · · ··correct?
22· ·A· ··Yes, sir.··The semi-annual inspection, again, was
23· · · ··approved because in technicality they did have an
24· · · ··SOP on file with the Agency.··And additionally, the
25· · · ··June method that we witnessed on site in 2021 was

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·1· · · ··entirely different than the method that we
·2· · · ··witnessed in December of 2020.
·3· · · · · · · · ··Furthermore, when we asked Michele Glinn
·4· · · ··to provide us the SOP that we witnessed on site in
·5· · · ··June of 2021 she sent us the version from December
·6· · · ··of 2020.··I emailed back to her, corresponded and
·7· · · ··said, "This is not the method that we witnessed on
·8· · · ··site.··I will need you to send me the method that
·9· · · ··you were using on site."··At that point in time,
10· · · ··nearly two weeks later, she finally sent us the
11· · · ··method that we witnessed on site in June of 2021
12· · · ··changing the method yet again.
13· ·Q· ··You testified last week regarding a method needing
14· · · ··revalidation when an SOP is provided, that it's, I
15· · · ··believe your words were, it's inherent.··Is that
16· · · ··right?
17· ·A· ··That a validation should be provided when
18· · · ··substantive changes are made to the method, yes, I
19· · · ··do believe that is inherent for a laboratory that's
20· · · ··conducting research.
21· ·Q· ··Okay.··And so do you recall technical guidance in
22· · · ··February of 2021 that specifically stated when a
23· · · ··method validation or revalidation would be
24· · · ··required?
25· ·A· ··I would have to review the documentation sent out

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·1· · · ··at that time, sir.
·2· ·Q· ··Okay.··So if -- if I told you that the four bullet
·3· · · ··points were submission of a new original method,
·4· · · ··expansion of the scope of an existing validated
·5· · · ··method to include additional matrices,
·6· · · ··modifications of the range of the method beyond
·7· · · ··validated levels, and modifications which
·8· · · ··significantly alter the method's performance such
·9· · · ··as fundamental technology or complete modification
10· · · ··of sample preparation, will you agree that that was
11· · · ··within the February 2021 technical guidance?
12· ·A· ··It absolutely may have been.
13· ·Q· ··Okay.··That sounds familiar to you?
14· ·A· ··Not exactly upon recall, but I have no reason to
15· · · ··disbelieve you.
16· ·Q· ··Okay.··And so would you agree with me if -- if you
17· · · ··apply these four standards based on what was
18· · · ··submitted to the CRA in November 2020 and again on
19· · · ··December 3rd, 2020, there would be no requirement
20· · · ··for new validation to be submitted?
21· ·A· ··I disagree with that entirely.··I think that what
22· · · ··they submitted between November and June of 2021
23· · · ··hit at least one of those standards that you just
24· · · ··outlined.
25· ·Q· ··So you would -- would you agree with me that it's

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·1· · · ··not a submission of a new or original method?
·2· ·A· ··It is the submission of a new and original method,
·3· · · ··yes, sir.
·4· ·Q· ··You believe it's a new method?
·5· ·A· ··Yes, sir, because they -- they altered the method
·6· · · ··to reintroduce kief, which are the trichomes
·7· · · ··containing cannabinoids, back into the sample.
·8· ·Q· ··Well, if you go back to the May 2020 SOP that you
·9· · · ··didn't require a new validation for, wasn't there
10· · · ··kief or wasn't there -- wasn't there scraping that
11· · · ··was done on the -- in that method as well?
12· ·A· ··So in that method the kief was scraped back into
13· · · ··the flower material and then that flower material
14· · · ··was rehomogenized, and that's the very important
15· · · ··distinction between what happened in May where they
16· · · ··simply, you know, clarified the term "homogenize"
17· · · ··versus what happened and what they submitted in,
18· · · ··well, December, where they were scraping
19· · · ··nonhomogeneous material back into homogeneous
20· · · ··material.··And then in June of 2021 when they were
21· · · ··taking those kief-laden grinding media, dropping
22· · · ··them into the extraction vial, and then adding a
23· · · ··very small amount of flower, which was much less
24· · · ··than what they validated in the first place.
25· · · · · · · · ··So in what they submitted in their

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·1· · · ··original validation they stated that they were
·2· · · ··going to use 1 gram of ground flower material.··And
·3· · · ··yet we identified them using as little as 0.2 grams
·4· · · ··or 20 percent of what they originally validated.
·5· · · ··And so I think that that actually hits another one
·6· · · ··of the four points that you mentioned.
·7· ·Q· ··The May 2020 SOP, the change to the sample prep and
·8· · · ··the scraping, changed the outcome.
·9· · · · · · · · ··You would agree with that; right?
10· ·A· ··No, sir, I disagree with that.··I believe that what
11· · · ··they did, and from what they stated that they did
12· · · ··and what we witnessed as well, is they attempted to
13· · · ··better clarify the term "homogenize" in order to
14· · · ··ensure greater consistency between how their
15· · · ··technicians were performing that method in
16· · · ··practice.
17· · · · · · · · ··Defining or better clarifying the term
18· · · ··"homogenize" is very different from choosing to
19· · · ··prepare the sample in a way that is no longer
20· · · ··homogeneous.··The fact that it went from
21· · · ··homogeneous to nonhomogeneous is, in and of itself,
22· · · ··a substantial deviation from the method.
23· ·Q· ··Isn't it true that the potency increased from
24· · · ··before the May 2020 updated SOP to after it?
25· ·A· ··We, I do not believe, witnessed any significant

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·1· · · ··increases in potency at that time.
·2· ·Q· ··Well, I didn't ask about significant.··I asked if
·3· · · ··there were increases.··Because, if you'll recall,
·4· · · ··you testified a couple of times that there was a
·5· · · ··complaint that the Viridis potency was too low.
·6· · · ··And actually they were put on a corrective action
·7· · · ··plan because of that.··And an updated SOP was part
·8· · · ··of that and -- I believe your testimony.
·9· ·A· ··So my testimony was that Viridis themselves noted
10· · · ··that there was a discrepancy between how their
11· · · ··technicians were performing that method and how
12· · · ··they interpreted the -- the term "homogenize."··And
13· · · ··so they sought to simply bring more harmony between
14· · · ··how those technicians were performing that method.
15· · · · · · · · ··Now, I think that that is a very
16· · · ··different analysis really of how they're performing
17· · · ··the method.··Whether it's higher or lower, the
18· · · ··point of it was to clarify the term "homogenize"
19· · · ··and to bring greater harmony to those results
20· · · ··themselves.
21· ·Q· ··The corrective action plan was dated, what,
22· · · ··May 18th, 2020?··Is that right?
23· ·A· ··It may have been.··That was initiated by the
24· · · ··laboratory.
25· ·Q· ··Well, initiated by the laboratory, but the fact

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·1· · · ··that there was a complaint was -- was conveyed by
·2· · · ··Dr. Chirio with you copied on it; correct?
·3· ·A· ··No, sir.··So actually I believe it was Todd Welch
·4· · · ··that conveyed to us that they had received a
·5· · · ··complaint from a client and they communicated that
·6· · · ··information with us.··And there was followup.··Just
·7· · · ··to be clear there, there was followup from the
·8· · · ··Agency just asking them to follow up with a
·9· · · ··corrective action because Mr. Welch had noted that
10· · · ··there was disparity between how those technicians
11· · · ··were performing and understanding the term
12· · · ··"homogenize."
13· ·Q· ··You would agree with me that during that
14· · · ··correspondence back and forth with Viridis North
15· · · ··and the CRA regarding this low-potency complaint,
16· · · ··you specifically required that Viridis perform a
17· · · ··corrective action plan to move forward; is that
18· · · ··right?
19· ·A· ··That may be the case.··Yes, absolutely.··So any
20· · · ··time a laboratory identifies a noncompliance with
21· · · ··our own internal SOPs, and as is indicated in the
22· · · ··laboratories quality management procedure and
23· · · ··manual, they are supposed to initiate a corrective
24· · · ··action.
25· · · · · · · · ··So, yes, I did request that they follow

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·1· · · ··their own internal procedures to initiate that
·2· · · ··action in order to ensure that their technicians
·3· · · ··were clear on what the term "homogenize" meant and
·4· · · ··then again to ensure that there was greater harmony
·5· · · ··between how they were performing those tests in
·6· · · ··accordance with our SOP.
·7· ·Q· ··Is it true that you sent an email on August 3rd,
·8· · · ··2021, where you specifically stated that you were
·9· · · ··not going to approve this Viridis method?··That you
10· · · ··claim that they're blatantly inflating potency,
11· · · ··period?
12· ·A· ··That may have been.··And that was after we issued
13· · · ··the June 2021 denial of the second at least
14· · · ··iteration of the method that we had seen.
15· ·Q· ··And so it was your position that no matter what,
16· · · ··you were never going to approve this method; is
18· ·A· ··Absolutely not.··No.··Not with what we had been
19· · · ··provided.··I would not approve a method unless we
20· · · ··had seen the appropriate validation.··And, sir, we
21· · · ··still have not seen the appropriate validation to
22· · · ··date.
23· ·Q· ··We'll get to that.
24· · · · · · · · ··So as far as the timeline goes, you had
25· · · ··the November 2020 back and forth emails with

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·1· · · ··Dr. Glinn where she provides the updated SOP, they
·2· · · ··pass both the June -- or the December and June
·3· · · ··2020/2021 semi-annual inspections, you had started
·4· · · ··an investigation in March.··You never make either
·5· · · ··Viridis laboratory aware of it.··And then in August
·6· · · ··of 2021 you personally signed four formal
·7· · · ··complaints against the two Viridis labs; correct?
·8· ·A· ··So I want to go back a little bit.
·9· · · · · · · · ··The investigation began in January of
10· · · ··2021.··Viridis received a denial of the method that
11· · · ··they submitted in June of 2021.··The Agency
12· · · ··continued to investigate or had various
13· · · ··investigations regarding their noncompliance.··And
14· · · ··then, yes, sir, I did sign formal complaints
15· · · ··against the laboratory at that point in time.
16· ·Q· ··So you just testified that they received a denial
17· · · ··of their method in June of 2021, but that's
18· · · ··actually not accurate; is it?··What you submitted
19· · · ··was a denial of a validation that was -- that you
20· · · ··never received; correct?
21· ·A· ··Yes, sir.··And that is absolutely what happened.
22· · · · · · · · ··At that point in time, because we had
23· · · ··been working on this with Viridis for the better
24· · · ··part of seven months and Viridis did not seem to be
25· · · ··clear in the fact that they were not approved to

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·1· · · ··use that SOP, we did respond to them with official
·2· · · ··method denial despite the fact that they never
·3· · · ··submitted the materials that they were supposed to
·4· · · ··because they were using this in practice in the
·5· · · ··laboratory consistently for a period of time, and
·6· · · ··we thought it was necessary to draw their attention
·7· · · ··to this in a very matter of fact way.
·8· · · · · · · · ··And then the laboratory continued to use
·9· · · ··this method and is still using this method today
10· · · ··despite the fact that they have received an actual
11· · · ··denial, official, issued from the Agency.
12· ·Q· ··You testified that there seemed to be some
13· · · ··confusion by the two Viridis laboratories on
14· · · ··whether they're approved or not.··I mean, at this
15· · · ··point that you're talking about when you claim you
16· · · ··sent this denial in late June of 2021, at this
17· · · ··point, if we go back to the timeline, they've had
18· · · ··two semi-annual inspections, you've watched the
19· · · ··method four times, and there's been no denial; is
21· · · · · · · · ··MS. HUYSER:··Your Honor, at this point
22· · · ··I'm going to object.··Not only has this been asked
23· · · ··and answered, it's a multiple compound question,
24· · · ··and it's more like testimony than actually asking a
25· · · ··question.··And it's kind of argumentative with the

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·1· · · ··witness as well.
·2· · · · · · · · ··MR. RUSSELL:··I'll move on, Your Honor.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you, Counsel.
·4· · · · · · · · ··And, Mr. Russell, please try to break up
·5· · · ··your questions into questions and not questions
·6· · · ··followed by testimony followed by another question.
·7· · · ··Okay?
·8· · · · · · · · ··MR. RUSSELL:··Yes, Your Honor.
·9· ·Q· ··(MR. RUSSELL) So you did sign four complaints in
10· · · ··August of 2021; correct?
11· ·A· ··Yes, sir.
12· ·Q· ··Okay.··And so when you issue a complaint for the
13· · · ··laboratories, is it true that you issue a complaint
14· · · ··for both medical and recreational for both?··Is
15· · · ··that why there are four?
16· ·A· ··Yes, sir.
17· ·Q· ··And would you agree that the formal complaints that
18· · · ··were filed in August of 2021 all follow the
19· · · ··December and the June semi-annual inspections, what
20· · · ··happened at those semi-annual inspections?
21· ·A· ··Not the semi-annual inspection, sir, but rather the
22· · · ··noncompliances that we witnessed by the laboratory
23· · · ··using an unapproved method, as witnessed by the
24· · · ··Agency.
25· · · · · · · · ··MR. RUSSELL:··Judge, I'd like to show the

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·1· · · ··witness the formal complaints, but these are one of
·2· · · ··the -- the complaints themselves are protected by
·3· · · ··the protective order that we have in place.··So I
·4· · · ··guess I'd like some guidance on how to do this.··I
·5· · · ··was going to try to do it without bringing these
·6· · · ··exhibits up.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Keep in mind, I issued
·8· · · ··an amended protective order that unsealed a large
·9· · · ··portion of the superseding complaints and only kept
10· · · ··those portion of the complaints, things that
11· · · ··discussed I think it was proprietary work or maybe
12· · · ··potentially proprietary allegations.··I'm not
13· · · ··certain.··I couldn't be certain until we have
14· · · ··exhibits.··So keep in mind that, you know, I issued
15· · · ··a second amended protective order and that seals
16· · · ··any discussion or testimony regarding, you know,
17· · · ··proprietary information only.
18· · · · · · · · ··MR. RUSSELL:··Thank you Judge.
19· ·Q· ··(MR. RUSSELL)··I'm going to show what's been marked
20· · · ··as Exhibit 32.
21· · · · · · · · ··JUDGE GOLDSTEIN:··That's what you
22· · · ··originally submitted it as?
23· · · · · · · · ··MR. RUSSELL:··Yes, Your Honor.
25· ·Q· ··(MR. RUSSELL) Do you recognize that document?

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·1· ·A· ··Yes, sir.
·2· ·Q· ··Okay.··And is this an accurate depiction of formal
·3· · · ··complaints that were signed -- or one of the formal
·4· · · ··complaints I should say, to clarify, that was
·5· · · ··signed by you on August 25th, 2021?
·6· ·A· ··Yes, sir.
·7· ·Q· ··Okay.··And if you look down at -- starting on 10b,
·8· · · ··I believe that the complaints tracked the two
·9· · · ··semi-annual inspections.··Am I wrong?
10· ·A· ··They were separate.··They occurred on the same day.
11· · · ··Again, semi-annual inspections are one thing, and
12· · · ··then information leading to an investigation is
13· · · ··another.··But yes, they did occur on the same day
14· · · ··and during the same interaction.
15· ·Q· ··You would agree that neither one of the
16· · · ··laboratories were made aware that there was
17· · · ··anything that was being conducted outside of a
18· · · ··semi-annual inspection on these -- on the December
19· · · ··date and the June date; correct?
20· ·A· ··They were aware of it given that we did do an audit
21· · · ··of the potency method at that time, and we had had
22· · · ··ongoing discussions regarding the potency method.
23· ·Q· ··I'm going to direct your attention to 10c.··I asked
24· · · ··you about this a little bit earlier.··And it states
25· · · ··"Respondent used alumina beads for grinding during

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·1· · · ··sample preparation and not the stainless steel
·2· · · ··balls approved in respondent's SOP.··Alumina beads
·3· · · ··are ceramic beads made of aluminum oxide and are a
·4· · · ··significant deviation from the manufacturer's
·5· · · ··instructions.··No research and development studies
·6· · · ··are available regarding this unapproved
·7· · · ··substitution, and there's no evidence that this
·8· · · ··method would produce scientifically accurate test
·9· · · ··results."
10· · · · · · · · ··Did I read that correctly?
11· ·A· ··Yes, sir, you did.
12· ·Q· ··Okay.··And so -- and I am going to show you this
13· · · ··again so we can get into it.··The validation from
14· · · ··January 2020, if, in fact, the January 2020
15· · · ··approved SOP was validated using alumina beads,
16· · · ··then this would be a false statement in this
17· · · ··complaint; is that correct?
18· ·A· ··I don't believe that it would be a false statement
19· · · ··given that it states alumina beads are made of
20· · · ··aluminum oxide and are a significant deviation from
21· · · ··the manufacturer's instructions.··That is a true
22· · · ··statement.
23· ·Q· ··But am I right that the formal complaints are
24· · · ··alleging that the two Viridis laboratories were in
25· · · ··violation of the administrative rules?

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·1· ·A· ··No, that is exactly what this alleges, yes, sir.
·2· ·Q· ··And then your allegation is they're in violation of
·3· · · ··the administrative rules because they're failing to
·4· · · ··adhere to their approved SOP?
·5· ·A· ··This is one very minor portion of our allegation.
·6· ·Q· ··Oh, I see.··Okay.··So how do you determine what in
·7· · · ··here is a minor allegation?··Because in this it
·8· · · ··specifically states it's a significant deviation
·9· · · ··from the manufacturer's instructions.
10· ·A· ··It is a significant deviation from the
11· · · ··manufacturer's instructions.··That is true.
12· ·Q· ··Okay.··And isn't it also true that the manufacturer
13· · · ··actually sent you a letter telling you that the use
14· · · ··of aluminum ceramic beads was, in fact, appropriate
15· · · ··after this complaint was filed?
16· ·A· ··I do not recall if the manufacturer sent me that
17· · · ··necessarily.··I do know that I spoke with the
18· · · ··manufacturer, and they stated exactly how they
19· · · ··would recover trichomes from their grinding media
20· · · ··and rehomogenize it with their samples if they were
21· · · ··to be themselves grinding and homogenizing product
22· · · ··like this.
23· ·Q· ··Looking down at 10f, "Additionally respondent
24· · · ··stated that the weight of the sample was
25· · · ··approximately .5 to 1 gram of material.··Usually

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·1· · · ··around .5 grams.··The approved SOP states the
·2· · · ··analysis required 1 gram of homogenized cannabis
·3· · · ··plant material."
·4· · · · · · · · ··Did I read that correctly?
·5· ·A· ··Yes, you absolutely did.
·6· ·Q· ··Okay.··And when we talked about the November emails
·7· · · ··back and forth between you and Dr. Glinn I believe
·8· · · ··this was something that was discussed.··Do you
·9· · · ··recall that?
10· ·A· ··Yes, I believe this was discussed.
11· ·Q· ··Okay.··And I believe that you took issue with the
12· · · ··fact that the SOP said approximately 1 gram.··Do
13· · · ··you recall that?
14· ·A· ··Yes, I do, because the laboratory validated or
15· · · ··verified this initial method at 1 gram, and
16· · · ··Dr. Michele Glinn herself said that any weight that
17· · · ··they used under 1 gram would result in an increased
18· · · ··relative standard deviation and, therefore,
19· · · ··decreased accuracy of the sample reporting results
20· · · ··themselves.
21· ·Q· ··Did the approved SOP state approximately 1 gram,
22· · · ··yes or no?
23· ·A· ··Yes, it did.
24· ·Q· ··Okay.··And so the allegation in this complaint is
25· · · ··that the two Viridis laboratories are not compliant

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·1· · · ··with the administrative rules because they're
·2· · · ··failing to comply with their SOP because they're
·3· · · ··using approximately 1 gram of material; is that
·4· · · ··right?
·5· ·A· ··Because they're using approximately, not at all,
·6· · · ··1 gram of their material.··0.5 to 1 gram is not
·7· · · ··approximate and it is not in line with their
·8· · · ··validation.··The only approximation that they
·9· · · ··should be using around 1 gram would be the
10· · · ··appropriate calibration deviation based on whatever
11· · · ··scales that they were using, which is typically
12· · · ··limited to about one-tenth of a gram.··So
13· · · ··approximate in this case would mean 0.9 grams to
14· · · ··1.1 grams.··So the fact that they stated that they
15· · · ··were using as low as 0.5 grams is a deviation.
16· · · · · · · · ··Additionally, we have evidence that they
17· · · ··were using as little as 0.2 grams, despite the fact
18· · · ··that they told us that they were using 0.5 grams.
19· ·Q· ··So there's nothing in the SOP that was -- they were
20· · · ··in violation with by using between 0.5 to 1 gram of
21· · · ··material?
22· ·A· ··Yes, sir, they were in violation of the fact that
23· · · ··they were not using 1 gram.
24· ·Q· ··And so where did you get the tolerances for your
25· · · ··approximation?

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·1· ·A· ··So what a laboratory should do when they are
·2· · · ··operating any sort of method is they use the method
·3· · · ··based on the verification or the validation that
·4· · · ··they submitted in the first place.··What the
·5· · · ··laboratory submitted and what they validated and
·6· · · ··verified in their laboratory was that they would
·7· · · ··use exactly 1 gram.··And this is further evidenced
·8· · · ··by the fact that initially, I believe it was back
·9· · · ··in January of 2020, we discussed this very specific
10· · · ··issue with Dr. Glinn herself, and she stated that
11· · · ··they should use exactly 1 gram because the AOAC
12· · · ··themselves stated that anything under that would
13· · · ··result in increased relative standard deviation.
14· · · · · · · · ··So the fact that they went back to then
15· · · ··use less sample, homogenized flower, despite the
16· · · ··fact that she knew that that would decrease the
17· · · ··certainty in their test results, is absolutely a
18· · · ··deviation from what they submitted to us.
19· ·Q· ··The SOP said approximately 1 gram; correct?··Yes or
20· · · ··no?
21· ·A· ··Yes, sir.
22· ·Q· ··Okay.··And what you just testified was they had to
23· · · ··use exactly 1 gram; is that correct?
24· ·A· ··No, sir, I reiterated what was in their validation.
25· · · ··What I stated prior to that is that the only

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·1· · · ··acceptable deviation that would result in the term
·2· · · ··"approximate" would be acceptable deviation based
·3· · · ··on the calibration of their scale, which is
·4· · · ··typically limited to 0.1 grams based on, you know,
·5· · · ··the quality and the weight measurements that they
·6· · · ··use on those scales in the laboratory space.··So
·7· · · ··that's an analytical calibration certainty
·8· · · ··measurement.
·9· ·Q· ··It goes on in 10i of this complaint to say
10· · · ··"Finally, the respondent's use of unapproved method
11· · · ··consistently produced potency results substantially
12· · · ··higher than the approved SOP creating falsified
13· · · ··records."
14· ·A· ··Yes, sir.
15· ·Q· ··Did I read that correctly?
16· ·A· ··Yes, you did.
17· ·Q· ··Okay.··And so in this complaint your allegation is
18· · · ··that the two Viridis laboratories are falsifying
19· · · ··records; is that right?
20· ·A· ··Yes, sir.
21· ·Q· ··And I believe it was your testimony and I believe
22· · · ··it's in this complaint that you believe that these
23· · · ··alleged violations of the rules are a public health
24· · · ··and safety risk.··Is that correct?
25· ·A· ··Yes, sir.··Any time a laboratory does not adhere

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·1· · · ··consistently to their SOPs approved by the Agency,
·2· · · ··that very well could be a threat to public health
·3· · · ··and safety.
·4· · · · · · · · ··And further I would like to clarify that
·5· · · ··falsification is defined as manipulation of
·6· · · ··research materials, equipment, processes, and then
·7· · · ··changing or admitting data or results such that the
·8· · · ··research is not accurately represented in the
·9· · · ··research method.··Not to be confused with
10· · · ··fabrication which is defined as making up data or
11· · · ··results.
12· ·Q· ··And you're aware that these complaints were
13· · · ··eventually superseded by the complaints we're here
14· · · ··for today; correct?
15· ·A· ··Yes, sir.
16· ·Q· ··And are you aware that this tribunal issued a
17· · · ··protective order as it related to certain documents
18· · · ··in this matter?
19· ·A· ··Yes, sir.
20· ·Q· ··Okay.··Were you aware that the complaint that we're
21· · · ··looking at here with these salacious allegations
22· · · ··was included as protected in that protective order?
23· ·A· ··Yes, sir.
24· ·Q· ··Okay.··Were you also aware that after that
25· · · ··protective order was issued that the CRA published

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·1· · · ··these formal complaints on their website for anyone
·2· · · ··to look at?
·3· ·A· ··That is part of the CRA's procedure; however, I did
·4· · · ··not become aware of that until after it occurred
·5· · · ··and I was not responsible for that.
·6· ·Q· ··But you're aware that that occurred; is that right?
·7· ·A· ··Yes, I am.
·8· ·Q· ··After this -- these formal complaints were issued,
·9· · · ··do you recall an investigation or I guess
10· · · ··investigative report that was filed by
11· · · ··Allyson Chirio in September of 2021?
12· ·A· ··I am sure that there was one that was filed.··I
13· · · ··would have to review the details of it to be able
14· · · ··to offer any additional information.
15· ·Q· ··So I'm going to show you what's been marked as
16· · · ··Exhibit 44.
17· · · · · · · · ··MR. RUSSELL:··Make sure the comments are
18· · · ··off the side if they pop up, please.
19· ·Q· ··(MR. RUSSELL) Do you recognize this document?
20· ·A· ··Yes, I do.
21· ·Q· ··Okay.··And is this an accurate depiction of a
22· · · ··complaint that was filed by Allyson Chirio on
23· · · ··November 27, 2021?
24· ·A· ··This is an accurate depiction of the investigation,
25· · · ··yes, sir.

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·1· ·Q· ··Okay.··And you approved this, so it appears at
·2· · · ··least on the front page, on October 13th, 2021?
·3· ·A· ··Yes, sir.
·4· · · · · · · · ··MR. RUSSELL:··Judge, I'd move to have
·5· · · ··this investigative report moved into evidence as
·6· · · ··Exhibit 15.
·7· · · · · · · · ··MS. HUYSER:··I have no objection.··I just
·8· · · ··wanted to clarify it was just a misspeaking, but
·9· · · ··it's September 27th, not November 27th.
10· · · · · · · · ··MR. RUSSELL:··Oh, did I say September --
11· · · ··did I say November?
12· · · · · · · · ··MS. HUYSER:··Yeah, and then you went back
13· · · ··to October, so . . .
14· · · · · · · · ··MR. RUSSELL:··Sorry about that.
15· · · · · · · · ··JUDGE GOLDSTEIN:··What was this
16· · · ··originally marked?
17· · · · · · · · ··MR. RUSSELL:··This was originally marked
18· · · ··44.
19· · · · · · · · ··JUDGE GOLDSTEIN:··I'm not showing that
20· · · ··one.··Is that under somebody else's dep exhibits by
21· · · ··chance?
22· · · · · · · · ··MR. RUSSELL:··No.··No, Judge.
23· · · · · · · · ··MR. SCHUMACHER:··It's Rosenzweig 21.
24· · · · · · · · ··MR. RUSSELL:··No, it's 44, though.··It
25· · · ··was in the original 44.··It also would be under

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·1· · · ··Rosenzweig 21.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··So it is under a dep
·3· · · ··exhibit, then.
·4· · · · · · · · ··Yep, I have that one.··Okay.··I'll bring
·5· · · ··that in as 15.
·6· · · · · · · · ··MR. RUSSELL:··Yes, Your Honor.··Thank
·7· · · ··you.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Viridis Exhibit 15 is
·9· · · ··admitted.
11· ·Q· ··(MR. RUSSELL) So I want to first look at the
12· · · ··associated cases on the first page of -- so the
13· · · ··associated cases that are listed, would it be fair
14· · · ··to say that those are open investigations at that
15· · · ··time into Viridis laboratories?
16· ·A· ··Not necessarily.··They may have been closed.
17· · · ··They're just related to the same events.
18· ·Q· ··Okay.··So maybe my question wasn't clear.··So in
19· · · ··2021, in September 2021, would it be fair to say
20· · · ··that these were related to potency complaints that
21· · · ··the CRA had investigating or was investigating?
22· ·A· ··Had investigated or was investigating, yes.
23· ·Q· ··Okay.··So if I count correct it appeared, including
24· · · ··this, there were 12 investigations that were
25· · · ··ongoing at this time; is that right?

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·1· ·A· ··With the reminder that there is a new investigation
·2· · · ··number issued for every license.··So 12 divided by
·3· · · ··4 is 3.
·4· ·Q· ··So looking down to the -- are you okay -- second
·5· · · ··page in the summary.··Sorry, we're having technical
·6· · · ··difficulties for a second here.
·7· ·A· ··No worries.
·8· · · · · · · · ··MR. RUSSELL:··Judge, can we take a break?
·9· · · · · · · · ··JUDGE GOLDSTEIN:··Yes.··We've been going
10· · · ··for a while.··Why don't we break till 11:10.··Sound
11· · · ··good?
12· · · · · · · · ··MR. RUSSELL:··Yes.··Thanks, Judge.
13· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··We're off
14· · · ··the record at 10:52.··Thank you.
15· · · · · · · · ··(Break taken at 10:52 AM)
16· · · · · · · · ··(Break concluded at 11:14 AM)
18· · · ··the matter of Viridis Laboratories, LLC, and
19· · · ··Viridis North versus Cannabis Regulatory Agency,
20· · · ··consolidated Docket Numbers 21-029794, et al.··The
21· · · ··time is 11:13 AM.
22· · · · · · · · ··Counsel, you may continue.
23· · · · · · · · ··MR. RUSSELL:··Thank you, Your Honor.
24· · · · · · · · ··MS. HUNT-SCULLY:··I'm sorry, Dave.··Can
25· · · ··you hear me okay?

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·1· · · · · · · · ··MR. RUSSELL:··Yes.
·2· · · · · · · · ··MS. HUNT-SCULLY:··I'm sorry.··I'm sorry
·3· · · ··to interrupt, but we -- we at the break had a
·4· · · ··chance to look over today's amended protective
·5· · · ··order, or second amended protective order, and it
·6· · · ··does seem to have some different numbering, the
·7· · · ··paragraph -- or reference to paragraph numbers,
·8· · · ··then the March of 2023.··And I don't know whether
·9· · · ··that was intentional or was it -- the March -- for
10· · · ··instance, in paragraph 1 in today's order it
11· · · ··references that paragraph 7B2 and 7C6 1 and 2, they
12· · · ··will be sealed, but the March 2023 one references
13· · · ··paragraphs 6.··So I just wanted to make sure that
14· · · ··everyone was on the same page.
15· · · · · · · · ··JUDGE GOLDSTEIN:··Let me pull it up.
16· · · · · · · · ··MR. RUSSELL:··Judge, I was only able to
17· · · ··look at this on my phone.··Can we just take a
18· · · ··minute if we're going to discuss this?
19· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Yeah, Risa,
20· · · ··go through your concerns again.··You're talking
21· · · ··about the order part?
22· · · · · · · · ··MS. HUNT-SCULLY:··Yeah, the -- the
23· · · ··amended order today is different than the
24· · · ··March 2023 amended order in that a lot of the
25· · · ··paragraph numbers have changed.··And the March 2023

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·1· · · ··references paragraph 6 but today references
·2· · · ··paragraph 7.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Oh, in like 1, 2, and 4
·4· · · ··there?
·5· · · · · · · · ··MS. HUNT-SCULLY:··Yeah.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Well, I'll go
·7· · · ··check that after we get through the hearing.··It's
·8· · · ··probably the -- the -- a copy of the issued amended
·9· · · ··protective order.··I'm afraid to go onto the
10· · · ··network because we'll get kicked off again.
11· · · · · · · · ··MS. HUNT-SCULLY:··I get it.
12· · · · · · · · ··JUDGE GOLDSTEIN:··Let me check that over
13· · · ··the lunch break.
14· · · · · · · · ··MS. HUNT-SCULLY:··Okay.
15· · · · · · · · ··JUDGE GOLDSTEIN:··Because I don't want to
16· · · ··get kicked off again.
17· · · · · · · · ··MR. RUSSELL:··Risa, you were breaking up
18· · · ··a little bit.··Just so I have it in my notes for
19· · · ··when we take a break for lunch to look at what --
20· · · ··can you say that again what the paragraph you're
21· · · ··referring to?
22· · · · · · · · ··MS. HUNT-SCULLY:··So in -- for instance,
23· · · ··in paragraphs 1 and 2 in today's order it
24· · · ··references paragraphs 7B2 and 7-6 -- or C6, 1 and
25· · · ··2, but in the March 2023 order I believe that it --

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·1· · · ··and I haven't had a ton of time to look at this
·2· · · ··myself either -- but I believe the March 2023 order
·3· · · ··references paragraph 6.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··You're right, Ms. Risa.
·5· · · ··I just pulled up --
·6· · · · · · · · ··MS. HUNT-SCULLY:··Okay.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··-- the one you got.
·8· · · ··I'm going to have to reissue it.··It's an error on
·9· · · ··that.··The correct one that was issued is the one
10· · · ··you're talking about.
12· · · · · · · · ··JUDGE GOLDSTEIN:··So the second amended
13· · · ··protective order I'm going to have to issue an
14· · · ··amendment to it to correct the error --
16· · · · · · · · ··JUDGE GOLDSTEIN:··-- in the paragraph.··I
17· · · ··see what you're talking about now.
18· · · · · · · · ··MS. HUNT-SCULLY:··Yes.··Thank you.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah, thank you for
20· · · ··bringing that to my order.
21· · · · · · · · ··Now, was that your only concern regarding
22· · · ··the order?
23· · · · · · · · ··MS. HUNT-SCULLY:··Yes.
24· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.
25· · · · · · · · ··Counsel, did you have a comment about it?

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·1· · · · · · · · ··MR. RUSSELL:··No, Judge.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Very good.
·3· · · · · · · · ··At this point -- so let me just describe
·4· · · ··the -- we'll break at noon for lunch and reconvene
·5· · · ··at 1:10.
·6· · · · · · · · ··Any need to break early today?
·7· · · · · · · · ··MS. HUNT-SCULLY:··(Moves head from side
·8· · · ··to side)
·9· · · · · · · · ··MR. RUSSELL:··I don't either, Judge.
10· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··So I have a
11· · · ··few things to take up at the end of the day, so
12· · · ··we'll go to 4:30 today.··All right?
13· · · · · · · · ··All right.··Counsel, you may continue.
14· · · · · · · · ··MR. RUSSELL:··Thank you, Judge.
15· ·Q· ··(MR. RUSSELL) Ms. Patterson, we're continuing to
16· · · ··look at this investigative report from September
17· · · ··2021.··I want to ask you some additional questions
18· · · ··about these associated cases.
19· · · · · · · · ··Now, my understanding is that these
20· · · ··associated cases were related to complaints that
21· · · ··were all filed after the August 2021 formal
22· · · ··complaints were issued.··Do you know if that's
23· · · ··correct?
24· ·A· ··I do not without looking at them.··I apologize.
25· ·Q· ··To the extent that I'm correct, without going

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·1· · · ··through each of these, would the CRA include
·2· · · ··complaints related -- associated cases as part of
·3· · · ··its investigation for the August 2021 complaint?
·4· ·A· ··Again, I would have to confirm the dates on those.
·5· · · ··They may have, depending on the circumstances.··I
·6· · · ··would have to better understand the details.
·7· ·Q· ··And I understand that, and I'm not asking you to
·8· · · ··concede that any of these are post-August, but if
·9· · · ··there is a post-August, which I believe these all
10· · · ··are post-August complaints, would those be used as
11· · · ··support for the August formal complaint?
12· ·A· ··No.··So if I'm understanding you correctly, if
13· · · ··these were filed or began investigation after
14· · · ··August and they didn't overlap in timeline, there
15· · · ··would be no reason for them to contain,
16· · · ··necessarily, the same information; however, they
17· · · ··are on the same subject matter due to the ongoing
18· · · ··complaints and ongoing noncompliance with the
19· · · ··administrative rule.··So there certainly may be
20· · · ··some overlap, if I'm understanding correctly.
21· ·Q· ··Are you aware of any licensee or anyone outside of
22· · · ··the CRA making a complaint about either Viridis
23· · · ··laboratory's potency prior to your August 2021
24· · · ··formal complaint?
25· ·A· ··There may have been.··Honestly, it's been such a

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·1· · · ··long time, and we've received numerous complaints
·2· · · ··from various parties outside of the Agency
·3· · · ··regarding Viridis's potency and practices related
·4· · · ··to that.··But without the details I can't put a
·5· · · ··specific timeline on it, sir.··I apologize.
·6· ·Q· ··So I just want to make sure I understand what your
·7· · · ··testimony is, then.
·8· · · · · · · · ··If you get -- if you were to receive a
·9· · · ··complaint post August 2021, you may use that as
10· · · ··support of that complaint; is that right?
11· ·A· ··So if -- if the complaint was already -- the formal
12· · · ··complaint was already issued, I do not believe that
13· · · ··we would be able to retroactively go back into that
14· · · ··complaint and make amendments.··But to clarify,
15· · · ··these are the same, similar, related, intertwined
16· · · ··issues.
17· · · · · · · · ··I guess maybe I'm not entirely
18· · · ··understanding what it is that you're asking me.
19· ·Q· ··Well, what I'm asking you is there's a formal
20· · · ··complaint issued, there's a request for the
21· · · ··investigative file, and in receipt of that is all
22· · · ··these associated cases, or at least the majority of
23· · · ··them, that relate to complaints that are post
24· · · ··complaint filed -- I know that's confusing because
25· · · ··I'm talking about the complaint by the CRA in

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·1· · · ··August 2021 that -- filed by you and then what the
·2· · · ··licensee receives subsequently when seeking the
·3· · · ··investigative report.··And all the associated
·4· · · ··cases, or at least a majority of those, are
·5· · · ··complaints that are made post August 2021.··That
·6· · · ··doesn't make sense to me.
·7· ·A· ··To be honest, sir, your question doesn't make sense
·8· · · ··to me either.
·9· ·Q· ··Okay.··So let me try to clarify it, then, because
10· · · ··it probably wasn't really well-worded.
11· · · · · · · · ··August 25th, 2021, we can agree you
12· · · ··signed these four formal complaints related to the
13· · · ··two semi-annual inspections and the potency issue
14· · · ··that you raised; correct?
15· ·A· ··Yes, sir.
16· ·Q· ··Okay.··And at that time Viridis becomes aware that
17· · · ··there's these four formal complaints and there's a
18· · · ··request for the investigative report?
19· ·A· ··That are associated with the formal complaint that
20· · · ··I signed in August of 2021.
21· ·Q· ··Correct.
22· ·A· ··Correct.
23· ·Q· ··Fair enough.··Do you understand that?
24· ·A· ··Yes.
25· ·Q· ··Okay.··Investigative report is received.··There are

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·1· · · ··numerous associated cases and complaints that are
·2· · · ··provided as part of that investigative report that
·3· · · ··are subsequent to the August 2021 CRA formal
·4· · · ··complaint.··That doesn't make sense why there would
·5· · · ··be subsequent complaints that are being used as
·6· · · ··support for the August CRA complaint.
·7· ·A· ··I don't know that they would have been used as
·8· · · ··support, they may have just been associated cases.
·9· · · ··I can't speak to that.··I apologize.
10· ·Q· ··You approved this investigative report in October
11· · · ··2021; correct?
12· ·A· ··Yes, sir.
13· ·Q· ··Okay.··And this investigative report is part of
14· · · ··that package that was -- that is -- was being used
15· · · ··to support the August formal complaints; correct?
16· ·A· ··Well, I don't see how a report that was signed in
17· · · ··October of '21 could have been used to support
18· · · ··something that occurred in August of '21.··So I
19· · · ··think that where the confusion may be here is that
20· · · ··these are interrelated ongoing issues related to
21· · · ··noncompliance and potency.··And, you know, there
22· · · ··may be shared information.··Certainly there may be
23· · · ··shared data given that this was an ongoing issue
24· · · ··that was very arguably narrow in scope.··Maybe
25· · · ··that's where some of the confusion is coming in.

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·1· · · ··I'm sorry that I'm not able to offer more
·2· · · ··assistance.
·3· ·Q· ··So is it your testimony, then, that this October
·4· · · ··approved investigative report isn't part of the
·5· · · ··August formal complaint, isn't part of that file to
·6· · · ··support that?··Is that your -- is that your
·7· · · ··testimony?
·8· ·A· ··Yes, sir, that is my -- my testimony.
·9· · · · · · · · ··As an Agency we continue to investigate
10· · · ··noncompliant behavior that is ongoing.··So, again,
11· · · ··these things are -- are certainly related,
12· · · ··absolutely, and there may be shared data,
13· · · ··information, and things of that nature.··But the
14· · · ··complaint continued over time.··So these things
15· · · ··occur in chronological order.··Despite the fact
16· · · ··that they may be related, they're filed
17· · · ··chronologically.
18· ·Q· ··So over the course of time and then your testimony,
19· · · ··you just continued to accrue new complaints against
20· · · ··the licensee?··Is that the protocol?
21· ·A· ··Yes.··If a licensee continues to be noncompliant
22· · · ··with the administrative rules and we continue to
23· · · ··receive complaints we are required to investigate
24· · · ··them, yes.
25· ·Q· ··Now I want to move down to the report a little bit

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·1· · · ··to the summary.··And the first paragraph in the
·2· · · ··summary says "Beginning in December 2020,
·3· · · ··Viridis Laboratories was notified that based on the
·4· · · ··most recent currently available science from
·5· · · ··peer-reviewed literature, any marijuana flower
·6· · · ··exceeding 28 percent total THC is in the 99th
·7· · · ··percentile based on the biochemical limitations of
·8· · · ··the cannabis plant itself."
·9· · · · · · · · ··And then the summary cites El Sohly 2016.
10· · · ··Do you see that?
11· ·A· ··Yes, sir.
12· ·Q· ··Okay.··And are you familiar with that literature?
13· ·A· ··I -- I may be.··And I believe that this may be a
14· · · ··more outdated study.··I believe that it's like, you
15· · · ··know, a 2016, so it's a little bit older.
16· ·Q· ··Okay.··And then it goes on in the next sentence to
17· · · ··say "This means that on average no more than
18· · · ··approximately 1 percent of all potency results
19· · · ··reported by a testing laboratory should exceed
20· · · ··28 percent."
21· · · · · · · · ··Did I read that --
22· ·A· ··Yes, sir, you did.
23· ·Q· ··Okay.··And so based on this El Sohly referenced
24· · · ··literature, that's the contention in this
25· · · ··investigative report; is that correct?

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·1· ·A· ··Yes, sir.
·2· ·Q· ··Okay.··And so I would assume that -- well, I won't
·3· · · ··assume.··I'll ask you.··Since you did approve this
·4· · · ··investigative report, you must have reviewed that
·5· · · ··literature.··Is that right?
·6· ·A· ··Yes, sir.
·7· · · · · · · · ··MS. HUNT-SCULLY:··Okay.··And so I want to
·8· · · ··actually switch over to -- we'll come back to the
·9· · · ··complaint in a second, but can you bring up Exhibit
10· · · ··79?
11· · · · · · · · ··Can you make it a little bit bigger for
12· · · ··her?
13· · · · · · · · ··THE WITNESS:··Thank you.
14· ·Q· ··(MR. RUSSELL) Okay.··Do you recognize this article?
15· ·A· ··Yes.
16· ·Q· ··Okay.··And would you agree that this is the article
17· · · ··that is cited in the September 2021 investigative
18· · · ··report?
19· ·A· ··Yes, that is the article cited in that report
20· · · ··specifically.··I believe we updated it later to
21· · · ··include additional support.
22· ·Q· ··Okay.··So this article -- based on this article,
23· · · ··this is where the CRA made the determination that
24· · · ··no more than approximately 1 percent of all potency
25· · · ··results reported by a testing laboratory should

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·1· · · ··exceed 28 percent; is that correct?
·2· ·A· ··This is the article that we referenced in that
·3· · · ··investigative report, though I will say it is one
·4· · · ··of the many articles that we referenced to come to
·5· · · ··that determination.
·6· ·Q· ··Okay.··So you say the many articles that you
·7· · · ··reference.··What other articles have you
·8· · · ··referenced?··Because I don't know that I've seen
·9· · · ··any.
10· ·A· ··Sir, there again, I cannot reiterate to you the
11· · · ··names of the articles and the various articles that
12· · · ··we've looked at published by various authors, but
13· · · ··as a plant biologist who understands biochemistry,
14· · · ··there are limitations to the amount of THC that a
15· · · ··plant can produce or the amount of cannabinoids,
16· · · ··phytocannabinoids, that a plant can produce.··So,
17· · · ··yes, this is one of the articles, one of the
18· · · ··resources that are available in scientific
19· · · ··literature.
20· ·Q· ··And I understand that your memory does have limits,
21· · · ··but can you point me to anything in any of your
22· · · ··investigative reports or any of your semi-annual
23· · · ··inspections or anything where I can find what other
24· · · ··literature you looked at?··Because wouldn't you
25· · · ··agree that how you arrived at this is an important

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·1· · · ··point?
·2· ·A· ··Certainly, yes.··And I would direct you
·3· · · ··specifically to the Jikomes and Zoorob article.··I
·4· · · ··believe it was published in 2019 potentially?··I
·5· · · ··think that that's correct.··Again, I'd have to
·6· · · ··reference to be sure.··But I know that that one
·7· · · ··explicitly states the claim that we've discussed
·8· · · ··here.
·9· · · · · · · · ··Again, I believe there is a Meyer's
10· · · ··article.··I know I very recently have read an
11· · · ··article about the phytochemical limitations in the
12· · · ··cannabis plant.··And part of the challenge of that,
13· · · ··further, is the fact that, you know, cannabis is
14· · · ··newly limited, limitedly, I guess, legal in some
15· · · ··spaces.··So we're really looking at the available
16· · · ··literature as it's published right now in realtime.
17· · · · · · · · ··But, yes, if you would like to review
18· · · ··that reference specifically, I would point you to
19· · · ··Jikomes and Zoorob.··And I believe that's -- that
20· · · ··one is quite clear.
21· ·Q· ··And so when you say that you would point me to
22· · · ··that, was that cited anywhere in any of your
23· · · ··reports?
24· ·A· ··Yes, sir, I believe it was.
25· ·Q· ··Okay.··And which one?

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·1· ·A· ··I would have to review them again.··My memory is
·2· · · ··not quite as expansive as I would hope.
·3· ·Q· ··Well, let's stick with this, this literature here,
·4· · · ··because this is the one that's cited for this
·5· · · ··proposition of the 1 percent not exceeding 28
·6· · · ··percent.
·7· · · · · · · · ··And then this investigative report, as
·8· · · ··we're going to see --
·9· ·A· ··Sure.
10· ·Q· ··-- has some pretty salacious allegations.··So I
11· · · ··want to make sure that the scientific literature
12· · · ··that you're relying on actually says what you claim
13· · · ··it says.
14· · · · · · · · ··Now, this isn't very long.··I think it's
15· · · ··what, four pages long?··First of all, would you
16· · · ··agree with me that this article is referring to
17· · · ··illicit product only?
18· ·A· ··Yes, sir, this does refer to illicit product only.
19· ·Q· ··Okay.··So this is -- this is a -- illicit product.
20· · · ··This has nothing to do with the regulated market;
21· · · ··is that correct?
22· ·A· ··Yes, it is.
23· ·Q· ··Okay.··And the study that's set forth in this
24· · · ··article, would you agree that it's from 2009 to
25· · · ··2019?

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·1· ·A· ··Yes, I believe.··Well, no.··Hold on.··I don't know
·2· · · ··if that's quite correct.
·3· · · · · · · · ··Oh, yep, there it is.··Okay.··Yes, 2009
·4· · · ··to 2019.··I apologize.
·5· ·Q· ··All right.··I'd like you to tell me in this article
·6· · · ··where I can look to find that 1 percent of all
·7· · · ··potency results reported by a testing laboratory
·8· · · ··should exceed 28 percent.
·9· ·A· ··Sorry, I'd have to read this entire article if you
10· · · ··would like me to even begin to come toward that
11· · · ··conclusion.··I don't believe that that's stated
12· · · ··explicitly in here, but, again, I would point you
13· · · ··to the Jikomes article.
14· ·Q· ··Well, I believe you're right, it is absolutely not
15· · · ··explicitly stated in here.
16· ·A· ··Sure.
17· ·Q· ··It's not even inherently or explicitly in here.
18· · · · · · · · ··So you would agree with me, though --
19· · · ··because I'd like you to read it, we can take the
20· · · ··time, I think it's a very important point -- that
21· · · ··there's nothing in this article that supports
22· · · ··that -- that allegation?
23· ·A· ··If you wouldn't mind, I'd be happy to skim it.
24· ·Q· ··Sure.
25· ·A· ··If you could pause there for just a moment, that

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·1· · · ··would be great.··Thank you.
·2· · · · · · · · ··Go ahead and go down.··Go ahead and go
·3· · · ··down.··And again, please.
·4· · · · · · · · ··So one of the first things that we see
·5· · · ··here on the far right side, "In conclusion, our
·6· · · ··results show an overall increase in potency of
·7· · · ··illicit cannabis ranging up to approximately
·8· · · ··14 percent in 2019."··Granted, that's not the
·9· · · ··28 percent, and that is a relatively low but
10· · · ··average number for cannabis potency.
11· · · · · · · · ··Would you continue to go down for me,
12· · · ··please?
13· · · · · · · · ··And, again, we see that bump up looks to
14· · · ··be about 15 percent here in Figure 1 seems to be
15· · · ··the average.··Of course, with the acknowledgment
16· · · ··that the DEA during this period of time is likely
17· · · ··seizing illicit product, but that the market is
18· · · ··changing, of course.··And that is in 2018.··So
19· · · ··that's about an average representation there.
20· · · · · · · · ··Would you continue to go down, please?
21· · · ··Let's see.
22· · · · · · · · ··That one is irrelevant.··Please continue.
23· · · · · · · · ··And continue to go down from there if you
24· · · ··wouldn't mind.
25· · · · · · · · ··Let's see here.··All right.··Figure 2A,

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·1· · · ··again, it was close there.··14.88 percent reported
·2· · · ··in 2018.··I believe that's after at least some of
·3· · · ··the markets had gone at least through the medical
·4· · · ··transition.
·5· · · · · · · · ··And so to be fair, sir, you are right, it
·6· · · ··does not state 28 percent in here as being an
·7· · · ··average.··It actually states a bit closer to
·8· · · ··15 percent.··And I believe that the generous upward
·9· · · ··estimate of 28 percent, as I said, was stated in
10· · · ··additional literature, despite the fact that it was
11· · · ··not cited directly in this investigation report.
12· ·Q· ··So you cite -- or I should say I believe
13· · · ··Allyson Chirio cited and you approved this
14· · · ··literature from 2016 which cited illicit product,
15· · · ··and nowhere in that article anywhere comes to the
16· · · ··conclusion that approximately 1 percent of all
17· · · ··potency results reported by testing laboratories
18· · · ··should exceed 28 percent.··Am I right about that?
19· ·A· ··Yes, absolutely.··And I would note that that's very
20· · · ··likely an administrative error.··My -- my guess, as
21· · · ··is cited in the other investigation reports, is
22· · · ··that she meant to cite the Jikomes article as that
23· · · ··is explained explicitly in that article.··So while
24· · · ··you are correct absolutely, sir, I believe that's
25· · · ··an administrative error.

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·1· ·Q· ··So this investigative report from Dr. Allyson
·2· · · ··Chirio and then approved by you, there's
·3· · · ··administrative error that includes a reference to
·4· · · ··an article on illicit product, and that's just a
·5· · · ··clerical error?
·6· ·A· ··Yes, sir, that is a clerical error, an
·7· · · ··administrative error.
·8· ·Q· ··I mean, wouldn't you agree with me that what you're
·9· · · ··citing this for, the proposition you're citing for
10· · · ··this is -- completely misrepresents what that
11· · · ··article states?
12· ·A· ··I would state that this administrative error was
13· · · ··misattributed, absolutely.··But, again, the article
14· · · ··that we just referenced was stating that average
15· · · ··THC is typically around 15 percent.··So I believe
16· · · ··that eliciting or including another 13 percent on
17· · · ··that gives quite a buffer in favor of the licensee.
18· · · · · · · · ··So, yes, I'm fully admitting to the fact
19· · · ··that that is likely an administrative error, but
20· · · ··the point still stands, ultimately, scientifically,
21· · · ··from that perspective.
22· ·Q· ··But the point doesn't stand.··You're citing an
23· · · ··article about illicit product which is completely
24· · · ··different than the regulated market, and you're
25· · · ··citing it for a specific proposition that you've

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·1· · · ··testified is the reason that --
·2· · · · · · · · ··MS. HUYSER:··Objection, Your Honor.
·3· · · ··Argumentative.
·4· · · · · · · · ··MR. RUSSELL:··It's not argumentative,
·5· · · ··Your Honor.
·6· · · · · · · · ··MS. HUYSER:··And asked and answered.
·7· · · · · · · · ··MR. RUSSELL:··I'm sorry?
·8· · · · · · · · ··MS. HUYSER:··And asked and answered.
·9· · · ··This is the same question so far that you answered
10· · · ··and she acknowledged an answer.
11· · · · · · · · ··MR. RUSSELL:··Well --
12· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, you just
13· · · ··disagree with her interpretation.··You have a
14· · · ··different opinion.··She's already answered the
15· · · ··question.··Objection sustained.
16· ·Q· ··(MR. RUSSELL) If you go down to the bottom of
17· · · ··page 2 where the complaint -- it starts
18· · · ··"Viridis Laboratories is continuing to falsify the
19· · · ··potency data reported into the Metrc system.
20· · · ··Falsification of data can occur at any step of the
21· · · ··scientific method and process.··Research misconduct
22· · · ··in the scientist is a serious issue, so much so
23· · · ··that guidelines have been established to create
24· · · ··clear boundaries regarding what is deemed research
25· · · ··misconduct."

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·1· · · · · · · · ··And it goes on to say "A statement
·2· · · ··developed by the U.S. Office of Science and
·3· · · ··Technology policy which has been adopted by most
·4· · · ··research-funding agencies defines misconduct as
·5· · · ··fabrication, falsification, or plagiarism in
·6· · · ··proposing, performing, or reviewing research or in
·7· · · ··reporting research results."
·8· ·A· ··Yes, sir.
·9· ·Q· ··Did I read that correctly?
10· ·A· ··Yes, you absolutely did.
11· ·Q· ··Okay.··And so would -- citing this scientific
12· · · ··literature for the proposition, would that be
13· · · ··considered fabrication, falsification, or
14· · · ··plagiarism?
15· ·A· ··No.··We didn't manipulate research materials,
16· · · ··equipments, or processes.··An administrative error
17· · · ··is a far, far different scenario than actually
18· · · ··manipulating the research that you're conducting in
19· · · ··a laboratory space and reporting out as licensed by
20· · · ··a government agency to clients who are paying you
21· · · ··for purchase and consumption by consumers of the
22· · · ··state of Michigan.
23· ·Q· ··Your complete audit -- not yours, but the CRA's
24· · · ··complete audit -- is based on the premise that it's
25· · · ··anomaly to have anything over 28 percent if you're

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·1· · · ··over 1 percent of your samples.··I'm right about
·2· · · ··that; correct?
·3· ·A· ··Yes, absolutely.
·4· ·Q· ··Okay.··And so you have -- you being the CRA, I
·5· · · ··guess, and Allyson Chirio, you can't actually cite
·6· · · ··to any scientific research to support that, but you
·7· · · ··are using this El Sohly article to do so; correct?
·8· ·A· ··No, that is incorrect, sir.··I'd like to reiterate
·9· · · ··that this was an administrative error that should
10· · · ··have pointed to the Jikomes and Zoorob articles
11· · · ··specifically.··And I do want to apologize again.··I
12· · · ··believe it's from 2019.
13· · · · · · · · ··So, no, this was an administrative error.
14· ·Q· ··Then it goes on on page 2 to state "The reported
15· · · ··potency data is not supported by current
16· · · ··literature."··Again, that's referring to the
17· · · ··El Sohly article that we just looked at; correct?
18· ·A· ··No, sir, it would have been cited incorrectly here.
19· · · ··But I believe broadly "literature" the term is used
20· · · ··as there's no specific citation in this space.
21· ·Q· ··And the data itself was generated using a method
22· · · ··that was not approved by the Agency, is not a
23· · · ··referenced method from peer-reviewed literature,
24· · · ··and not validated to AOAC Appendix K; is that
25· · · ··correct?

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·1· ·A· ··All of those things are true and are still true.
·2· ·Q· ··Okay.··And we're going to get into that, obviously.
·3· ·A· ··Sure.
·4· ·Q· ··You indicated it's -- it's not a referenced method
·5· · · ··from peer-reviewed literature; correct?
·6· ·A· ··Yes, sir.
·7· ·Q· ··And it's your testimony today that as we sit here
·8· · · ··today the method being used by both the Viridis
·9· · · ··laboratories hasn't been peer reviewed?
10· ·A· ··Not through the appropriate processes, no, it has
11· · · ··not.
12· ·Q· ··The question was has it been peer reviewed.··Yes or
13· · · ··no?
14· ·A· ··Through the typical processes of peer review, no,
15· · · ··sir, it has not.
16· ·Q· ··Has it been peer reviewed by the AOAC?
17· ·A· ··It has been peer reviewed by the AOAC's R-Squared
18· · · ··Program, which is actually only set up to assess
19· · · ··instrument -- basically instrument performance as
20· · · ··it relates to the method.··And this method and the
21· · · ··claims that are being made under the R-Squared
22· · · ··Program are currently being reviewed by the AOAC.
23· ·Q· ··And it goes on to say "and was not validated to
24· · · ··AOAC Appendix K."
25· · · · · · · · ··As you sit here today, do you believe

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·1· · · ··that's true?
·2· ·A· ··Yes, sir, I do.··And that is another claim that is
·3· · · ··being reviewed by the AOAC at this time.
·4· ·Q· ··We'll get into that in a little bit.··I want to go
·5· · · ··on in the investigative report, and it discusses a
·6· · · ··phone call that was allegedly received from an
·7· · · ··anonymous individual by Intelligence Analyst
·8· · · ··Garrett Shireman.
·9· · · · · · · · ··Do you recall this in the report?
10· ·A· ··Yes, sir.
11· ·Q· ··Now, first of all, is it typical for the CRA to use
12· · · ··anonymous sources in their investigative reports to
13· · · ··support their complaints?
14· ·A· ··Well, yes, sir, when it is the source of a
15· · · ··complaint and the complainant is anonymous, we do
16· · · ··honor that.
17· ·Q· ··When you say you do honor that, what do you mean by
18· · · ··that?
19· ·A· ··Well, we have to allow the complainant to be
20· · · ··anonymous, and then per procedure we follow up on
21· · · ··the complaint.
22· ·Q· ··Okay.··And so as the manager that approved this,
23· · · ··what was it that you did to ensure that the
24· · · ··information received was accurate?
25· ·A· ··Well, the claim here stated "The reported potency

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·1· · · ··data is not supported by current literature and the
·2· · · ··data itself was generated using a method that was
·3· · · ··not approved by the Agency, is not a reference
·4· · · ··method from peer-reviewed literature, and was not
·5· · · ··validated to AOAC Appendix K."
·6· · · · · · · · ··This was authored in or around September
·7· · · ··of 2021 which was absolutely before any of this
·8· · · ··data was submitted to the AOAC for any type of
·9· · · ··approval, be it the R-Squared Program or otherwise.
10· · · · · · · · ··So the complaint still stands here.··The
11· · · ··investigative data still stands.··And the
12· · · ··associated complaint did come from an anonymous
13· · · ··individual.··So I suppose I'm confused as to what
14· · · ··it is you're asking, sir.
15· ·Q· ··Well, did you have a conversation with
16· · · ··Garrett Shireman to verify exactly what was said to
17· · · ··him during the phone call?
18· ·A· ··I believe that he sent an email that was associated
19· · · ··with this phone call.··I do believe it is included
20· · · ··in this report, though again I would -- I would
21· · · ··like to check that before I confirm that
22· · · ··information.
23· ·Q· ··And did you -- did you speak to this anonymous
24· · · ··individual?
25· ·A· ··No, sir, I did not.

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·1· ·Q· ··Did you ask to?
·2· ·A· ··I'm not entirely sure how I would contact an
·3· · · ··anonymous individual.
·4· ·Q· ··Well, they wanted to remain anonymous.··Did the CRA
·5· · · ··never know who this person was, that they were
·6· · · ··actually who they claimed to be?
·7· ·A· ··No, they're anonymous, sir.··They didn't claim, I
·8· · · ··don't believe, necessarily to be anyone other than
·9· · · ··a licensed grower.
10· ·Q· ··Have you ever heard any complaints from CRA
11· · · ··employees about Allyson Chirio asking them to put
12· · · ··facts in investigative reports that weren't true?
13· ·A· ··No.
14· · · · · · · · ··MS. HUNT-SCULLY:··Hey, Dave, just to let
15· · · ··you know, you have a comment that's visible.
16· · · · · · · · ··MR. RUSSELL:··Thank you.
17· · · · · · · · ··MS. HUNT-SCULLY:··Uh-huh.
18· ·Q· ··(MR. RUSSELL)··Have you ever received any
19· · · ··complaints from any CRA employees that
20· · · ··Allyson Chirio manipulated reports?
21· ·A· ··No.
22· ·Q· ··When you receive a report from an LSS, do you
23· · · ··always confirm the accuracy of the data within the
24· · · ··report?
25· ·A· ··It depends on the depths of what's going on

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·1· · · ··necessarily.··I mean, there are instances where the
·2· · · ··LSS will compile that data and I'll review the data
·3· · · ··that's associated with it particularly as it
·4· · · ··relates to scientific complaints.··But I do review
·5· · · ··all of the reports that I receive, so in a way I
·6· · · ··suppose you could say yes.
·7· ·Q· ··But, for instance, in this report you didn't
·8· · · ··actually review the article that was referenced;
·9· · · ··right?
10· ·A· ··I -- I did note that it was an article of
11· · · ··reference.··Again, the administrative error here is
12· · · ··apparent, but I'm not sure how that correlates to
13· · · ··the data contained within.
14· · · · · · · · ··MR. RUSSELL:··You can take that down.
15· ·Q· ··(MR. RUSSELL) Would you agree with me at this time
16· · · ··in September the CRA was receiving complaints from
17· · · ··competitor labs that were having -- that were
18· · · ··losing business?
19· ·A· ··I can't speak to whether or not they were losing
20· · · ··business, but yes, we did receive complaints from
21· · · ··competitor labs as well as other licensees.
22· ·Q· ··So you don't recall at any point receiving
23· · · ··complaints or reviewing complaints where the
24· · · ··competitive lab specifically indicated to the CRA
25· · · ··that it was losing business to Viridis?

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·1· ·A· ··They may absolutely have done so, but we would not
·2· · · ··have looked into whether or not they were actually
·3· · · ··losing business.··But there certainly were
·4· · · ··complaints made by other laboratories.
·5· ·Q· ··I'm going to show you what's been marked as
·6· · · ··Exhibit 40.
·7· ·A· ··Thank you.
·8· ·Q· ··Do you recognize these emails?
·9· ·A· ··Yes, sir.
10· ·Q· ··Okay.··And would these be an accurate depiction of
11· · · ··emails back and forth from CRA employees in other
12· · · ··laboratories?
13· ·A· ··It didn't seem like there was a lot of back and
14· · · ··forth in there, but these are certainly complaints
15· · · ··from various laboratories.
16· ·Q· ··Okay.··And you recognize these?··You've seen these
17· · · ··before?
18· ·A· ··Yes.
19· · · · · · · · ··MR. RUSSELL:··What exhibit are we on?
20· · · · · · · · ··MR. SCHUMACHER:··Exhibit 16.
21· · · · · · · · ··MR. RUSSELL:··I want to ask that this be
22· · · ··admitted as Exhibit 16.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Any objection, Counsel?
25· · · · · · · · ··JUDGE GOLDSTEIN:··And that was 40,

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·1· · · ··correct, what was marked as 40?
·2· · · · · · · · ··MR. RUSSELL:··Correct, Judge.··Thank you.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Let me just check to
·4· · · ··make sure I have it here.
·5· · · · · · · · ··I do have that.··Okay.··CRA -- excuse
·6· · · ··me -- Viridis exhibits -- I'm sorry, is this 16?
·7· · · · · · · · ··MR. RUSSELL:··Yes, Judge.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Is being admitted.
·9· · · · · · · · ··(Viridis Exhibit 16 is admitted.)
10· · · · · · · · ··JUDGE GOLDSTEIN:··Go ahead, Counsel.
11· ·Q· ··(MR. RUSSELL) I want to first talk about the email
12· · · ··on page 14 of 14.··Do you recognize that email?
13· · · · · · · · ··Ms. Patterson, I'm sorry, did you hear
14· · · ··me?
15· ·A· ··Yes, sir.··I said "yes, sir."
16· ·Q· ··Oh, you did?··I'm sorry, I didn't hear you.··It
17· · · ··must have cut out.
18· · · · · · · · ··In this email -- well, first of all, do
19· · · ··you know Dr. Stacey Anderson?
20· ·A· ··Yes.
21· ·Q· ··Okay.··And is she a lab director for Therapeutic
22· · · ··Health Choice?
23· ·A· ··Lab directer, lab manager.··She works at
24· · · ··Therapeutic Health Choice, though, yes.
25· ·Q· ··Okay.··So is that a safety compliance facility

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·1· · · ··that's licensed by the CRA?
·2· ·A· ··Yes, it is.
·3· ·Q· ··Okay.··So would that be a competitor lab to Viridis
·4· · · ··Laboratories or Viridis North?
·5· ·A· ··Yes, sir.
·6· ·Q· ··The bottom -- as part of this email complaint that
·7· · · ··you're receiving about Viridis, in the last
·8· · · ··paragraph it states "This was very concerning to me
·9· · · ··as 7 percent is a huge discrepancy for total THC,
10· · · ··so we went to a dispensary and purchased flower
11· · · ··that had been tested by Viridis."
12· · · · · · · · ··Would you agree with me that that would
13· · · ··be a poor way to make a determination of the THC
14· · · ··value of a sample?
15· ·A· ··Yes; however, the laboratory is free to do whatever
16· · · ··testing they so choose.··That doesn't mean that we
17· · · ··consider that for any of the data that we use in
18· · · ··the analysis of these investigations, nor the fact
19· · · ··that the laboratory was not following their SOP as
20· · · ··was approved by the Agency.
21· ·Q· ··Why would you -- you said you agreed that that
22· · · ··would be a poor way to test the sample.··Why is
23· · · ··that?
24· ·A· ··Well, because that's a very limited sample.
25· ·Q· ··And would you agree that a sample that is at a

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·1· · · ··dispensary such as this would have been
·2· · · ··adulterated?
·3· ·A· ··No.
·4· ·Q· ··Would you agree that the THC that results that --
·5· · · ··that they would get from such a sample would have
·6· · · ··all kinds of variables?
·7· ·A· ··There certainly could be additional variables as it
·8· · · ··relates to potency for sure.··I mean, my biggest
·9· · · ··concern with this would be the fact that a
10· · · ··competitive laboratory tested it and that there
11· · · ··were five samples that -- I mean, those are the
12· · · ··clear concerns that I would have with any sort
13· · · ··of -- I wouldn't even call those a study -- testing
14· · · ··of samples.
15· ·Q· ··So when the CRA receives this type of complaint,
16· · · ··though, there is an investigation that's opened
17· · · ··every time; is that right?
18· ·A· ··Yes, sir.
19· ·Q· ··Okay.··So this particular -- this complaint
20· · · ··received would be listed on one of those
21· · · ··investigative reports as a case; is that right?
22· ·A· ··Well, when it comes to Viridis in particular, these
23· · · ··complaints were being received by the Agency at a
24· · · ··very high volume, and I would say a lot of them
25· · · ··were combined per advice that I received from --

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·1· · · ··from my upper management.··We combined a number of
·2· · · ··them.
·3· · · · · · · · ··And then at one point -- and I believe it
·4· · · ··was in part due to a request by your client -- we
·5· · · ··were required to stop actually investigating this
·6· · · ··potency and simply state that the laboratory was
·7· · · ··not in compliance with their approved SOPs, and
·8· · · ··still are not to this date.
·9· ·Q· ··You were requested by Viridis Laboratories or
10· · · ··Viridis North to tell other laboratories that they
11· · · ··weren't in compliance with their SOPs?
12· ·A· ··No, sir, that is not what I stated.··I stated that
13· · · ··we as an agency were receiving these complaints
14· · · ··from all over the industry, competitive
15· · · ··laboratories as well as, as you saw, cultivators,
16· · · ··various other folks from the industry in a very
17· · · ··high volume.··And some of those complaints may have
18· · · ··been combined together if they were received at
19· · · ··similar times.
20· · · · · · · · ··And we did investigate them when they all
21· · · ··first started coming in, but eventually I was
22· · · ··advised to stop the continued investigation as it
23· · · ··was apparent that Viridis Lansing and Viridis North
24· · · ··had no intent to comply with the administrative
25· · · ··rules as they continued to use a method that was

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·1· · · ··unapproved by the Agency and actually was
·2· · · ··officially denied for use by the Agency.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··We're going to take a
·4· · · ··quick lunch here, and we will reconvene at 1:10 PM.
·5· · · ··We are off the record at 11:59 AM.··Thanks.
·6· · · · · · · · ··(Lunch break taken at 11:59 AM)
·7· · · · · · · · ··(Lunch break concluded at 1:13 PM)
·8· · · · · · · · ··JUDGE GOLDSTEIN:··This is on the record
·9· · · ··in the matter of Viridis Laboratories, LLC, and
10· · · ··Viridis North versus the Cannabis Regulatory
11· · · ··Agency, consolidated Dockets 21-029794, et al.··The
12· · · ··time is 1:14 PM.
13· · · · · · · · ··And let me take up the issue about the
14· · · ··transcripts.
15· · · · · · · · ··During the lunch hour I discussed that --
16· · · ··the issue of the transcripts.··It is my
17· · · ··understanding that both the AG and the -- Viridis
18· · · ··have ordered transcripts through Ms. Duda.
19· · · ··Correct?
21· · · · · · · · ··MS. HUNT-SCULLY:··(Moves head up and
22· · · ··down)
23· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··There is a
24· · · ··procedure where the tribunal can adopt an
25· · · ··independent court reporter's transcript production

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·1· · · ··as the official record.··The tribunal has no
·2· · · ··problem doing so if the parties agree.··I will just
·3· · · ··add that I'm going to need transcripts in this
·4· · · ··case.
·5· · · · · · · · ··And, Counsel, I think you indicated that
·6· · · ··at this point anyway the AG's Office was not
·7· · · ··planning on requesting one through the state
·8· · · ··contract, so . . .
·9· · · · · · · · ··Viridis, I'm certain you don't object to
10· · · ··having Ms. Duda prepare the official transcript.
11· · · · · · · · ··Is there any objection on behalf of the
12· · · ··Agency?
13· · · · · · · · ··MS. HUNT-SCULLY:··Your Honor, can I have
14· · · ··some time to think about it?··I'd like to discuss
15· · · ··it with my colleagues.
16· · · · · · · · ··JUDGE GOLDSTEIN:··Certainly.
17· · · · · · · · ··MS. HUNT-SCULLY:··Thank you.
18· · · · · · · · ··JUDGE GOLDSTEIN:··How long do you need, a
19· · · ··break or something?
20· · · · · · · · ··MS. HUNT-SCULLY:··Yeah, that would be
21· · · ··good.
22· · · · · · · · ··JUDGE GOLDSTEIN:··Do you know at this
23· · · ··point how long you'll need?
24· · · · · · · · ··MS. HUNT-SCULLY:··Oh.··Would it be okay
25· · · ··if we just did that at our next natural break?

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··I'm sorry, I didn't
·2· · · ··catch all that.··What did you say?
·3· · · · · · · · ··MS. HUNT-SCULLY:··Would it be okay if we
·4· · · ··could do that at our next break?
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Oh, you don't want to
·6· · · ··take a break now to do it?
·7· · · · · · · · ··MS. HUNT-SCULLY:··Correct.··I'm sorry.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··That's fine.··That's
·9· · · ··fine.
11· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Very good.
12· · · · · · · · ··Any other preliminary matters before we
13· · · ··continue?
14· · · · · · · · ··MR. RUSSELL:··No, Judge.
15· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, you may
16· · · ··continue with the questioning.
17· · · · · · · · ··MR. RUSSELL:··Thank you, Your Honor.
18· ·Q· ··(MR. RUSSELL) Ms. Patterson, prior to the
19· · · ··August 25th formal complaint being filed against
20· · · ··Viridis North and Viridis Laboratories as it
21· · · ··related to these potency complaints, is it true
22· · · ··that you would have made a determination about all
23· · · ··the impropriety that you believed was taking place
24· · · ··with their potency method?
25· ·A· ··Prior to that complaint being filed, yes, we did

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·1· · · ··have information that they were not following an
·2· · · ··approved procedure in their laboratory space.··We
·3· · · ··did continue to collect data as it was presented to
·4· · · ··us or additional information here and there, and
·5· · · ··all of that went into the investigative complaints
·6· · · ··that followed that.
·7· ·Q· ··When you say you continued to collect data, are you
·8· · · ··talking about complaints from other laboratories?
·9· ·A· ··No, sir.
10· ·Q· ··What are you referring to?
11· ·A· ··We witnessed that Viridis laboratories continued to
12· · · ··use a nonapproved method by way of the potency
13· · · ··audits, they continued to let us know that they
14· · · ··were not using an approved SOP, and they also
15· · · ··provided additional data by way of potency
16· · · ··preparation log sheets that indicated that they
17· · · ··were not using an approved SOP.
18· ·Q· ··Okay.··So your allegation is that they weren't
19· · · ··using the approved SOP.··You obviously included
20· · · ··that in the formal complaint.
21· · · · · · · · ··I guess what I'm asking you is subsequent
22· · · ··to the complaint being filed that you signed in
23· · · ··August 2021, were you still collecting data to make
24· · · ··a determination of whether the results were
25· · · ··inaccurate in some way?

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·1· ·A· ··Only to confirm by way of potency audits primarily
·2· · · ··that the laboratory was still using an unapproved
·3· · · ··SOP.··We did check in at various points in time and
·4· · · ··noted that they were not following the approved SOP
·5· · · ··but rather the officially denied SOP from June of
·6· · · ··2021.
·7· ·Q· ··So when you're referring to the potency audits are
·8· · · ··you talking about the audits where, if a sample
·9· · · ··exceeded I believe it was the 28 percent threshold,
10· · · ··then the laboratory was required to do a retest?
11· ·A· ··Yes, sir.
12· ·Q· ··Okay.··So that's the information that you were
13· · · ··collecting post August formal complaint was that
14· · · ··information; correct?
15· ·A· ··Yes.··And included within that were the preparation
16· · · ··sheets that clearly denote the use of the June of
17· · · ··2021 method as well as I believe statements from
18· · · ··the laboratory themselves stating that they were
19· · · ··using the June of 2021 method.
20· ·Q· ··Okay.··So -- but what I want to be clear on is your
21· · · ··testimony is you had made a determination that
22· · · ··whatever method was being used was not producing
23· · · ··accurate results.··That's your testimony; right?
24· ·A· ··I'm testifying specifically that the laboratory was
25· · · ··not following the administrative rules, and they

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·1· · · ··were acting in direct violation of the
·2· · · ··administrative rules by using an SOP that was not
·3· · · ··validated appropriately nor was approved by the
·4· · · ··Agency.
·5· ·Q· ··Okay.··Let me ask you more direct then.
·6· · · · · · · · ··Was your belief when you signed the
·7· · · ··August 2021 complaint that the results being
·8· · · ··produced by the two Viridis laboratories were
·9· · · ··inaccurate results?
10· ·A· ··Yes.··The method was not validated.
11· ·Q· ··Okay.··I understand that's your contention it was
12· · · ··not validated.
13· · · · · · · · ··Have you made a determination
14· · · ··specifically one way or the other that the method
15· · · ··itself wasn't producing accurate results?··Had you
16· · · ··done anything to make that determination?
17· ·A· ··Based on scientific literature as well as the fact
18· · · ··that the laboratory was operating outside of the
19· · · ··administrative rules, yes, we did make a
20· · · ··determination that it was not providing accurate
21· · · ··results.
22· ·Q· ··And so when you say based on scientific literature,
23· · · ··specifically what are you testifying about?
24· ·A· ··That there are biochemical limitations to the
25· · · ··amount of phytocannabinoids that a plant can

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·1· · · ··produce.
·2· · · · · · · · ··Viridis laboratories in history has
·3· · · ··reported results of upwards of 30 to 35 percent for
·4· · · ··15 percent of the total samples that they actually
·5· · · ··reported on.
·6· · · · · · · · ··So, as we discussed previously, reporting
·7· · · ··above 28 percent is in the 99th percentile, meaning
·8· · · ··if you test 100 samples, one of them will exceed 28
·9· · · ··percent.
10· · · · · · · · ··In the Viridis laboratories, in
11· · · ··particular Viridis North, there was a period of
12· · · ··time after these complaints were issued that the
13· · · ··laboratory was reporting up to 15 out of 100
14· · · ··samples at a total potency of between 30 and 35
15· · · ··percent.··That is an anomaly, and that tells me
16· · · ··that they were not producing accurate results.
17· ·Q· ··I'm going to show you what's been marked as
18· · · ··Exhibit 47 previously.··Can you tell me if you
19· · · ··recognize this email?
20· ·A· ··Yes, sir.
21· ·Q· ··Okay.··And looking at the bottom of page 1, the
22· · · ··email seems to originate from you to an Eric Smith
23· · · ··on October 5th, 2021.··And the subject is
24· · · ··"Questions regarding sample prep."··Is that
25· · · ··correct?

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·1· ·A· ··Yes, sir.
·2· ·Q· ··Okay.··So this email would have been sent
·3· · · ··approximately a little over a month, I guess, after
·4· · · ··you had signed these formal complaints, these four
·5· · · ··formal complaints; correct?
·6· ·A· ··Yes, sir.
·7· ·Q· ··Okay.··And so over a month after you signed these
·8· · · ··formal complaints you're asking questions to
·9· · · ··outside experts to try to make a determination of
10· · · ··whether this was a representative sample; correct?
11· ·A· ··No, sir, I was sending this information, or asking
12· · · ··these questions rather, to outside consultants or
13· · · ··individuals who in this case represent the
14· · · ··Geno/Grinder company to verify what we already knew
15· · · ··internally.
16· · · · · · · · ··And if you go up on this email chain
17· · · ··you'll note that they talk about actually
18· · · ··dissolving the cannabinoids from those grinding
19· · · ··media.··And I believe they talk about reintroducing
20· · · ··it by way of homogenization.
21· ·Q· ··So over a month after you've signed these formal
22· · · ··complaints you're reaching out to try to get some
23· · · ··kind of confirmation for your scientific
24· · · ··conclusion; is that correct?
25· ·A· ··I'm getting additional confirmation from something

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·1· · · ··that I already know without having a laboratory
·2· · · ··space that is accessible to me, yes, sir.
·3· ·Q· ··So going up to the top, I think you referenced the
·4· · · ··email response that you received from Eric Smith,
·5· · · ··and in that -- and that's dated October 5th, 2021.
·6· · · ··It looks like the same day he responds to you.··And
·7· · · ··it says "Some users rinse the balls of the solvent
·8· · · ··to collect residue, then evaporate the solvent."
·9· ·A· ··Uh-huh.
10· ·Q· ··Now, isn't that exactly what the Viridis method was
11· · · ··doing?
12· ·A· ··No, sir, it is not.··What the Viridis method is
13· · · ··doing is actually taking those grinding media and
14· · · ··adding them directly to the solvent as well as some
15· · · ··additional plant material.
16· · · · · · · · ··What this individual here is suggesting
17· · · ··that they do, and quite frankly is something that
18· · · ··would be much less concerning, would be to take
19· · · ··these grinding media, all of them that were used in
20· · · ··the homogenization of the plant material, putting
21· · · ··it in some sort of solution or solvent, evaporating
22· · · ··that solvent out, and then freeing the rest of
23· · · ··those trichomes from that empty vial, and then at
24· · · ··that point in time reintroducing them to the flower
25· · · ··material to ensure a homogeneous sample.··However,

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·1· · · ··that's not what Viridis is doing.
·2· ·Q· ··Well, a clear reading of this email, that doesn't
·3· · · ··seem to be what he's suggesting either.··That seems
·4· · · ··to be your interpretation of this email; correct?
·5· ·A· ··No, sir, it says "Some users rinse the balls with a
·6· · · ··solvent to collect the residue, then evaporate the
·7· · · ··solvent."··The keyword that's missing from
·8· · · ··Viridis's SOP is the evaporate portion.··I don't
·9· · · ··think that's an interpretation.··I think that's a
10· · · ··statement of fact.
11· · · · · · · · ··MR. RUSSELL:··You can take that down,
12· · · ··Lorri.
13· ·Q· ··(MR. RUSSELL) You were aware in October of 2022 the
14· · · ··AOAC certified that method that Viridis uses;
15· · · ··correct?
16· ·A· ··I am aware that the AOAC certified a portion of
17· · · ··this method through their R-Squared Program, yes,
18· · · ··sir.
19· ·Q· ··So it's your testimony here today that the
20· · · ··certification and validation that was provided by
21· · · ··the AOAC is incomplete?
22· ·A· ··Yes, sir.··The R-Squared Program is designed to
23· · · ··evaluate performance claims that are set by the
24· · · ··submitter, in this case Viridis Laboratories, on
25· · · ··application notes in specific.··And application

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·1· · · ··notes are instructions essentially to describe how
·2· · · ··an instrument or a piece of analytical equipment is
·3· · · ··used to detect cannabinoids.
·4· · · · · · · · ··I don't think that anyone at the Agency
·5· · · ··would argue that we're concerned with the fact that
·6· · · ··Viridis had or cannot detect cannabinoids, rather,
·7· · · ··the concern that we have in specific is their
·8· · · ··sample preparation and homogenization portion of
·9· · · ··the method, none of which was reviewed by the AOAC.
10· ·Q· ··So when the AOAC's experts testify to the fact that
11· · · ··they actually did review and validate the sample
12· · · ··preparation and the method itself, and you would --
13· · · ··that would be incorrect testimony on their part?
14· ·A· ··Well, I haven't heard them testify to that at this
15· · · ··point.··And we certainly do have communications
16· · · ··back and forth with the AOAC where they have stated
17· · · ··that this specific method is under review because
18· · · ··it may not be appropriate to have been certified
19· · · ··under this method as it relates specifically to
20· · · ··sample preparation and homogenization claims.
21· · · · · · · · ··Additionally I'd like to state that,
22· · · ··regardless of what the AOAC states, this has not
23· · · ··been approved by the Agency.··And that is a part of
24· · · ··the rule requirements as well.
25· ·Q· ··And that's really what it comes down to, right,

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·1· · · ··Ms. Patterson?··You can never accept the AOAC's
·2· · · ··certification because what the AOAC certification
·3· · · ··does is completely contradicts your scientific
·4· · · ··conclusion that it's somehow inflating potency and
·5· · · ··adding kief back; correct?
·6· ·A· ··No, sir.··If the licensee had actually performed a
·7· · · ··validation to the appropriate level that they
·8· · · ··should have, this method would be on its way to be
·9· · · ··an official method of analysis.
10· · · · · · · · ··I would like to note that there are two
11· · · ··official methods of analysis for the analysis of
12· · · ··cannabinoids in cannabis that have been authored
13· · · ··and issued by the AOAC.
14· · · · · · · · ··So to sit here and state that a program
15· · · ··certification from the R-Squared program somehow
16· · · ··exceeds an official methods of analysis from the
17· · · ··AOAC is -- is an outrageous claim.
18· ·Q· ··So I just want to be clear, then.··So when the
19· · · ··AOAC -- and they will testify to the fact that this
20· · · ··is the only certified marijuana potency method in
21· · · ··the world, that when they testify to that, that
22· · · ··will be false testimony; is that your --
23· ·A· ··Yes.··I would be truly shocked if the AOAC
24· · · ··testified to that, because I know for a fact that
25· · · ··the AOAC has issued 2018.10 and 2018.11 as official

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·1· · · ··methods of analysis for potency in cannabinoids.
·2· · · ··So I would find that very strange, sir.
·3· ·Q· ··So you just testified you had communication --
·4· · · ··you've had communications back and forth from the
·5· · · ··AO -- with the AOAC.··Was that specific to this
·6· · · ··certification?
·7· ·A· ··Yes, sir.
·8· ·Q· ··Okay.··So I recognize that there was an anonymous
·9· · · ··letter that was written to the AOAC asking them to
10· · · ··reconsider the certification by some folks who were
11· · · ··unhappy with it.··Were you part of drafting that
12· · · ··letter?
13· ·A· ··No, sir.
14· ·Q· ··Were you aware of that letter?
15· ·A· ··I was made aware of the letter and the fact that it
16· · · ··was sent to the Agency.
17· ·Q· ··You were?··And who made you aware of that letter?
18· ·A· ··Potentially Brian Hanna?··Maybe it was sent to our
19· · · ··safety compliance facility inbox.
20· ·Q· ··Who specifically from the AOAC did you talk to
21· · · ··about this certification?
22· ·A· ··Katerina, the chief scientific officer, which is
23· · · ··the individual that we asked to sign off on this
24· · · ··during mediation, actually.
25· ·Q· ··Well, I'd love to get into what we discussed at

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·1· · · ··mediation, and if your counsel is willing, I'm more
·2· · · ··than happy to go down that road, but I'm assuming
·3· · · ··that Ms. Huyser is going to state that those are
·4· · · ··inadmissible discussions.
·5· · · · · · · · ··MS. HUYSER:··Absolutely.
·6· · · · · · · · ··MR. RUSSELL:··That's what I thought.
·7· ·Q· ··(MR. RUSSELL)··What's Katerina's last name?
·8· ·A· ··Mastovska I believe.··I'd have to -- I'd have to
·9· · · ··look that up to be able to tell you specifically.
10· · · ··But she's the chief scientific officer at the AOAC.
11· ·Q· ··And so is Ms. Mastovska the only person from the
12· · · ··AOAC that you're willing to take a position or that
13· · · ··you believe can bind the AOAC?
14· ·A· ··Well, her in concert with the president.
15· ·Q· ··So -- okay that's -- so you have to receive from
16· · · ··either the chief science officer or the president
17· · · ··communication for you to believe that it's binding
18· · · ··on the AOAC, is that what I'm hearing you testify
19· · · ··to?
20· ·A· ··Well, you'd have to be more specific, sir.··So,
21· · · ··again, I'm not saying that this didn't receive some
22· · · ··certification through the R-Squared Program.··What
23· · · ··I'm telling you is that it didn't meet the
24· · · ··requirements of the administrative rules by way of
25· · · ··completion of a full validation.··This

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·1· · · ··certification simply stated that it met the
·2· · · ··standard performance requirements which are the
·3· · · ··basic requirements that a method meet.
·4· · · · · · · · ··Additionally, the sample preparation and
·5· · · ··homogenization portions, which are the portions of
·6· · · ··the method that are in question by the Agency, were
·7· · · ··not even remotely addressed in the R-Squared
·8· · · ··certification program.
·9· · · · · · · · ··So yes, sir, I am saying that I would
10· · · ··need signoff by both the president of the AOAC as
11· · · ··well as the chief scientific officer stating that
12· · · ··all of those requirements have been met as required
13· · · ··by the administrative rules.
14· · · · · · · · ··Additionally, we would need to receive
15· · · ··that as well as the formal validation through the
16· · · ··Agency in order to issue approval, which still has
17· · · ··not been issued to this date.
18· ·Q· ··You have received a copy of the validation, the
19· · · ··certification, all of that information that the
20· · · ··AOAC has provided; correct?
21· ·A· ··For this R-Squared Program that reports on the
22· · · ··ability of the instrument to perform its analytical
23· · · ··abilities, yes, I have received that.··However, it
24· · · ··was not submitted to the Agency for approval.··And
25· · · ··that was stated explicitly, I believe, by

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·1· · · ··Greg Michaud.
·2· ·Q· ··I missed what you just said.··It wasn't submitted
·3· · · ··what?
·4· ·A· ··It wasn't submitted to the Agency for approval.
·5· · · ··When that was submitted to us, it was simply a
·6· · · ··notification sent by Greg Michaud, and he noted
·7· · · ··specifically that he was not sending it to us for
·8· · · ··approval.··So I want to reiterate again that this
·9· · · ··method has not been submitted for approval through
10· · · ··the Agency.
11· ·Q· ··You do recognize or you are testifying that you
12· · · ··have received this and apparently you've read this;
13· · · ··correct?
14· ·A· ··Yes, sir.
15· ·Q· ··Okay.··And at some point did you say that it didn't
16· · · ··comply with Appendix K?
17· ·A· ··I'm not entirely sure of that.··Greg Michaud told
18· · · ··us that he wasn't submitting it to the Agency for
19· · · ··approval, he was just making us aware of it.
20· ·Q· ··But you did review it; correct?
21· ·A· ··Yeah.··Absolutely.
22· ·Q· ··And the CRA's technical guidance requires that all
23· · · ··method validations meet the AOAC's Appendix K or
24· · · ··Appendix J; correct?
25· ·A· ··If they are methods that have been essentially,

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·1· · · ··well, done in-house at a laboratory, yes.
·2· ·Q· ··CRA's technical guidance requires all cannabis
·3· · · ··methods to meet the AOAC's SMPRs; correct?
·4· ·A· ··For those that are peer reviewed and published by
·5· · · ··independent third parties, yes.
·6· · · · · · · · ··Additionally, if there is a method that
·7· · · ··is an in-house method, we do require that it meets
·8· · · ··Appendix K in full for the entirety of the method,
·9· · · ··which includes sample preparation as well as
10· · · ··homogenization, and also meets the sample -- or the
11· · · ··standard method performance requirements.
12· ·Q· ··What are the individual performance requirements
13· · · ··you're referring to?
14· ·A· ··Are you asking me specifically what they are for
15· · · ··the cannabinoid potency method or are you asking me
16· · · ··generally what they refer to?
17· ·Q· ··For the cannabinoid potency method.
18· ·A· ··Sir, I cannot list those off the top of my head.··I
19· · · ··would have to refer to the SMPR in order to be able
20· · · ··to recite those back to you.
21· ·Q· ··Be fair to say the CRA relies on the AOAC for
22· · · ··scientific guidance?
23· ·A· ··In some part, certainly; however, we are the
24· · · ··regulatory body.
25· ·Q· ··The AOAC's methods, I mean, they're written right

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·1· · · ··into the rules; is that correct?
·2· ·A· ··I know we do mention the AOAC, absolutely, the
·3· · · ··official methods of analysis.
·4· ·Q· ··Does the CRA require laboratories to use only
·5· · · ··methods that have been certified by the AOAC if
·6· · · ··those are available?
·7· ·A· ··If they are available, I believe that is what the
·8· · · ··rule states, yes.
·9· ·Q· ··Okay.··So if there's a potency method that has been
10· · · ··certified by the AOAC, a scientific -- or a
11· · · ··laboratory in Michigan would have to use that
12· · · ··method; correct?
13· ·A· ··Well, they would have to use that method.··For
14· · · ··example, here in the case of potency there are two
15· · · ··official methods of analysis for potency in the
16· · · ··analysis of cannabinoids.··However, if a laboratory
17· · · ··chose to do their own, you know, in-house method
18· · · ··and their own research, they would be permitted to
19· · · ··do so; however, they would have to validate that
20· · · ··method in its entirety from beginning to end to the
21· · · ··guidelines in AOAC Appendix K or Appendix J
22· · · ··accordingly, as well as meeting the standard method
23· · · ··performance requirements.
24· ·Q· ··What are the elements of the AOAC's Appendix K that
25· · · ··a lab has to fulfill?

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·1· ·A· ··All of them.··It depends on what specific method
·2· · · ··we're looking at.··And I believe that document is
·3· · · ··quite long, so, unfortunately, again, I won't be
·4· · · ··able to tell you all of the details of that.
·5· ·Q· ··What are the AOAC's SMPRs?
·6· ·A· ··Those are the standard method performance
·7· · · ··requirements.
·8· ·Q· ··And are those specified on your method validation
·9· · · ··summary forms?
10· ·A· ··The standard method performance requirements?··Yes,
11· · · ··I believe they are.
12· ·Q· ··So if a lab meets all the individual requirements
13· · · ··and it's so noted on that form, they would be
14· · · ··fulfilling the Appendix K; correct?
15· ·A· ··No, that is not correct.··What I stated was that if
16· · · ··the method has been peer reviewed by an independent
17· · · ··third party, published, and then the laboratory did
18· · · ··a verification of that method, they would also need
19· · · ··to meet the standard method performance
20· · · ··requirements essentially stating that the
21· · · ··laboratory is able to perform that method at the
22· · · ··same accuracy, precision, essentially the same
23· · · ··quality as the method developer.··So those are a
24· · · ··bit different things.
25· ·Q· ··So if there's some requirement that wasn't

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·1· · · ··fulfilled by the lab, that would be listed on the
·2· · · ··form; correct?
·3· ·A· ··If there was some requirement -- what exactly are
·4· · · ··we talking about here, I guess?··Could you clarify?
·5· ·Q· ··So we're talking about the -- if the lab meets all
·6· · · ··requirements, it would be noted on the form.··They
·7· · · ··would be fulfilling the Appendix K, which I believe
·8· · · ··you just testified to.
·9· ·A· ··Is this for a verification, sir, or for a
10· · · ··validation of the laboratory method?
11· ·Q· ··For a validation.
12· ·A· ··So if a laboratory performed a full method
13· · · ··validation, yes, we would note those deficiencies.
14· · · ··But a laboratory would need to go through the work
15· · · ··on their own independently or with a consultant to
16· · · ··be able to meet those requirements.
17· · · · · · · · ··I'm not still quite sure what you're
18· · · ··asking.
19· ·Q· ··So if a method met all the items of Appendix K, the
20· · · ··CRA would approve it; correct?
21· ·A· ··Yes, sir.
22· ·Q· ··Is the SPEX Geno/Grinder part of the AOAC
23· · · ··performance requirements?
24· ·A· ··Is -- no, the AOAC does not put instruments in
25· · · ··their standard method performance requirements.

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·1· · · ··It's simply an instrument that the licensee is
·2· · · ··using as a part of their sample preparation and
·3· · · ··homogenization portion.
·4· ·Q· ··So that wouldn't have anything to do with whether a
·5· · · ··lab fulfilled the Appendix K or not; correct?
·6· ·A· ··An instrument --
·7· ·Q· ··Right.
·8· ·A· ··-- would have nothing to do with whether or not a
·9· · · ··laboratory fulfilled those requirements.··However,
10· · · ··the manner in which a laboratory prepares and
11· · · ··homogenizes, or in this case does not homogenize, a
12· · · ··sample, that absolutely would be required as
13· · · ··something to be validated.
14· ·Q· ··Is using a screw-cap vial part of the AOAC's
15· · · ··performance requirements?
16· ·A· ··No, I don't think anyone is concerned about the use
17· · · ··of a screw-cap vial, sir.
18· ·Q· ··And that also doesn't have anything to do with
19· · · ··Appendix K, does it?
20· ·A· ··An item such as a screw-cap vial?··No.
21· ·Q· ··What are AOAC performance tested methods?
22· ·A· ··AOAC performance tested methods are essentially the
23· · · ··next step up from the R-Squared Program by which
24· · · ··vendors go through a certification process in order
25· · · ··to receive third-party review and oversight of

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·1· · · ··their methods.
·2· ·Q· ··Did the performance tested methods meet the AOAC's
·3· · · ··Appendix J or K?
·4· ·A· ··They are approved by the AOAC under their
·5· · · ··performance tested methods requirements.··I
·6· · · ··anticipate that they do meet the requirements
·7· · · ··specified under Appendix J and K.
·8· ·Q· ··And you're familiar with the R2 program?
·9· ·A· ··I am familiar with the fact that it exists, yes,
10· · · ··and as it relates to this case, absolutely, but
11· · · ··have never, honestly, seen it in any capacity used
12· · · ··outside of technical notes that instrument vendors
13· · · ··use to say essentially our instrument can detect
14· · · ··this thing, whatever the thing may be, in this case
15· · · ··cannabinoids.
16· ·Q· ··You list the R2 certification, that you're an
17· · · ··expert, on your CV as part of that; correct?
18· ·A· ··Say that again?
19· ·Q· ··You list on your CV that you are an expert reviewer
20· · · ··for the R2 program --
21· ·A· ··No, sir.
22· ·Q· ··-- is that correct?
23· ·A· ··I am an expert reviewer for the AOAC.
24· ·Q· ··So it doesn't sound like you know much about the
25· · · ··program.

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·1· · · · · · · · ··Are you aware of what the process is in
·2· · · ··having a method certified under this program?
·3· ·A· ··Well, I'm -- I'm not reviewing methods under the
·4· · · ··R-Squared program.··And, again, the only thing that
·5· · · ··I'm aware of is what the program is used for.
·6· ·Q· ··Going back to the question I asked about your CV,
·7· · · ··I'm looking at it right now, it says "AOAC expert
·8· · · ··reviewer for ERV and R2 programs."··Am I wrong what
·9· · · ··I'm looking at?
10· ·A· ··Oh, the Emergency Response Validation Program.
11· · · ··They're part of --
12· ·Q· ··And --
13· ·A· ··I'm not denying that it says that.··They're a part
14· · · ··of the same program.··However, I've only reviewed
15· · · ··methods for the emergency response validations and
16· · · ··not the R-Squared Program.··It's the same title.
17· ·Q· ··So that's false what's on your CV, that you're an
18· · · ··expert reviewer for the R2 program?
19· ·A· ··No, sir, it's part of the same title.··As I just
20· · · ··stated, I've only reviewed methods for the
21· · · ··emergency response validation portion of the
22· · · ··program.
23· ·Q· ··You've testified about the AOAC methods of
24· · · ··analysis.··I think you cited 2018.10 and 2018.11.
25· · · ··Those aren't methods for marijuana; correct?

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·1· ·A· ··No, they are.
·2· ·Q· ··Isn't it true that they're methods for hemp, not
·3· · · ··marijuana?
·4· ·A· ··No, it's not.
·5· ·Q· ··Now, the validation report that was provided for
·6· · · ··with the AOAC certification was almost 100 pages
·7· · · ··long; correct?
·8· ·A· ··For Viridis's submission?
·9· ·Q· ··Yes.
10· ·A· ··It may be.
11· ·Q· ··Okay.··Did you read all -- all those pages?
12· ·A· ··Yes, sir.
13· ·Q· ··And it covers sample preparation, instrument
14· · · ··parameters, selectivity, interference, recovery,
15· · · ··limits of detection, quantification, accuracy,
16· · · ··precision, robustness, repeatability, measurement
17· · · ··of uncertainty, agreement with SMPRs, and
18· · · ··performance on both proficiency test samples and
19· · · ··commercial samples.··Would you agree?
20· ·A· ··You essentially just reiterated the standard method
21· · · ··performance requirements in long form, but yes.
22· ·Q· ··Okay.··And would you agree that the validation
23· · · ··report that was part of the AOAC certification
24· · · ··included all that?
25· ·A· ··It did.··But, again, it did not address the sample

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·1· · · ··preparation and homogenization portions in full.
·2· · · · · · · · ··And additionally, one piece I'd like to
·3· · · ··add is that what was actually reviewed by the AOAC
·4· · · ··is still not what was submitted in the June of 2021
·5· · · ··method by Viridis.··We saw far more variation from
·6· · · ··sample to sample in how those samples were treated
·7· · · ··by the SOP -- or -- yeah, the SOP that Viridis had
·8· · · ··submitted to us.
·9· ·Q· ··Have you seen a letter from Scott Coates from the
10· · · ··AOAC confirming that the validations of this
11· · · ··Viridis potency method covered all the applicable
12· · · ··sections of AOAC's Appendix K?
13· ·A· ··I believe that what that letter actually states is
14· · · ··that it meets the standard method performance
15· · · ··requirements.··But, yes, I have seen that letter.
16· · · ··And that letter is currently under review by the
17· · · ··AOAC president and chief scientific officer.
18· ·Q· ··So you're saying that the letter from Scott Coates,
19· · · ··the senior director from the AOAC, actually isn't
20· · · ··correct or hasn't been finalized?
21· ·A· ··What -- I didn't say that it wasn't finalized, what
22· · · ··I stated is it doesn't meet our requirements of
23· · · ··rule.··It was simply worded to state that the
24· · · ··method met the standard performance requirements,
25· · · ··which I don't believe anybody and not even myself

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·1· · · ··would argue.··That's exactly what the performance
·2· · · ··claims on the method state, that it meets the
·3· · · ··standard method performance requirements.··However,
·4· · · ··that does not indicate that a validation to AOAC
·5· · · ··Appendix K was completed in full for the entirety
·6· · · ··of the method.
·7· ·Q· ··Because that validation, as has been written and
·8· · · ··has been determined by outside experts, has made a
·9· · · ··determination that the scientific conclusion from
10· · · ··the CRA was, in fact, false and that --
11· · · · · · · · ··MS. HUYSER:··Objection, Your Honor.··Is
12· · · ··this testifying or a question?
13· · · · · · · · ··MR. RUSSELL:··I'm asking if that's
14· · · ··correct or not.
15· ·Q· ··(MR. RUSSELL) Does the validation -- is it contrary
16· · · ··to what the CRA has alleged in all of its
17· · · ··complaints?
18· · · · · · · · ··MS. HUYSER:··Claire, hold on, the Judge
19· · · ··is talking.
20· · · · · · · · ··MR. SCHUMACHER:··I couldn't hear him.
21· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, I've heard
22· · · ··this line of testimony now repeatedly.··Okay?··You
23· · · ··have a difference of opinion as to whether the AOAC
24· · · ··has more credibility than Ms. Patterson and the
25· · · ··Agency.··I understand the position.··So when you go

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·1· · · ··on to these question/testimony episodes of
·2· · · ··questioning her about somebody else having superior
·3· · · ··knowledge than her, we've heard this already.
·4· · · ··You're just repeating the same questions.
·5· · · · · · · · ··The objection is sustained.
·6· ·Q· ··(MR. RUSSELL) I think you testified on direct
·7· · · ··examination that you started -- the CRA started
·8· · · ··investigating aspergillus issues in September 2021.
·9· · · ··Is that correct?
10· ·A· ··I believe it was September of 2021, yes.
11· ·Q· ··Okay.··And I believe your testimony that -- was
12· · · ··that the investigation into aspergillus was a
13· · · ··result of identifying issues from Metrc.··Is that
14· · · ··correct?
15· ·A· ··In part it was from identifying an incredibly low
16· · · ··failure rate and the total number of samples that
17· · · ··were reported into Metrc.··I believe that we had
18· · · ··also received some complaints around that time.
19· · · · · · · · ··Additionally, we had received at least
20· · · ··one Metrc ticket from a cultivator stating that
21· · · ··they had done testing elsewhere, performed no
22· · · ··remediation to get rid of the aspergillus, and then
23· · · ··had passed it without remediation at the Viridis --
24· · · ··one of the Viridis laboratories, I don't recall
25· · · ··which.

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·1· ·Q· ··And I believe that you testified to the Court of
·2· · · ··Claims that that was the reason that the
·3· · · ··investigation began, because you began to identify
·4· · · ··that in Metrc.··Correct?··That there was a fail
·5· · · ··that was later not remediated and passed at one of
·6· · · ··the Viridis laboratories; is that right?
·7· ·A· ··Yes, in part that is correct.
·8· ·Q· ··Okay.··And that -- assuming that's fact, that fact
·9· · · ··in and of itself is not a violation of any rule;
10· · · ··correct?
11· ·A· ··No, that fact is not a violation of the rule.
12· ·Q· ··And is it true that when a processor remediates
13· · · ··product that that gets put on a label?
14· ·A· ··I don't believe so, no.··I don't think there's any
15· · · ··rule requirements requiring a label for
16· · · ··remediation.··And I believe that's actually
17· · · ··currently under discussion as to whether or not
18· · · ··that should be required.··It's a pretty hot-button
19· · · ··issue.
20· ·Q· ··So when a product is remediated, there isn't any
21· · · ··identification on that product when it goes to
22· · · ··market that it's been remediated?··Is that your
23· · · ··testimony?
24· ·A· ··Yes, it is.··I don't believe that there is any
25· · · ··requirement for that.··There may be some processors

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·1· · · ··or cultivators that opt to do that in spirit of
·2· · · ··informed consent, I believe, but it's not a
·3· · · ··requirement from the Agency.
·4· ·Q· ··Do you recall a complaint received from -- do you
·5· · · ··know who Steadfast is?
·6· ·A· ··Yes, sir.
·7· ·Q· ··And is Steadfast a safety compliance facility?
·8· ·A· ··Yes, sir.
·9· ·Q· ··Okay.··And do you recall a complaint from Steadfast
10· · · ··on September 10th, 2021, related to aspergillus?
11· ·A· ··I'm not sure if was related to aspergillus
12· · · ··specifically, but I do recall that there was a
13· · · ··complaint, yes, sir.
14· ·Q· ··Okay.··Do you recall the nature of the complaint?
15· ·A· ··That it was generally a complaint about Viridis,
16· · · ··and it was issued by Steadfast, specifically Avi
17· · · ··Zallen who's their owner.
18· ·Q· ··Do you recall that the Steadfast complaint stated
19· · · ··that it's easily confirmed by looking at how they
20· · · ··failed real microbial testing at Steadfast in the
21· · · ··past at the fraudulent labs.··Some of the products
22· · · ··were not remediated, just sent out to the fraud
23· · · ··labs in the past.
24· · · · · · · · ··Do you recall that?
25· ·A· ··I don't recall that specifically, but that sounds

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·1· · · ··like something that Steadfast would say in a
·2· · · ··complaint.
·3· ·Q· ··Okay.··Let me -- let me show you that email to see
·4· · · ··if it refreshes your recollection.
·5· ·A· ··Sure.··Thank you.
·6· · · · · · · · ··MR. RUSSELL:··Page 3.··That is?··Okay.
·7· · · · · · · · ··THE WITNESS:··Okay.
·8· ·Q· ··(MR. RUSSELL)··Okay.··Do you see that at the
·9· · · ··bottom?
10· ·A· ··The last thing I see, sir, is "I respectfully urge
11· · · ··and beg the MRA to look at the Metrc data and do
12· · · ··the right thing."
13· ·Q· ··And if you look at the start of that paragraph.
14· · · ··That's what I just read to you there.··I'm sorry.
15· ·A· ··Thank you.··Yes, I do see that statement.
16· ·Q· ··Okay.··And is that -- that complaint, the language
17· · · ··in that complaint, when you're talking about being
18· · · ··remediated, is that what you're talking about, that
19· · · ··someone like Steadfast fails a sample, and then
20· · · ··it's sent to another lab, and then it passes
21· · · ··without anything done to the product?··Is that what
22· · · ··your testimony is?
23· ·A· ··Well, my testimony is not based on Steadfast's
24· · · ··complaint but rather what we actually witnessed in
25· · · ··the data and through Metrc at the Agency.··However,

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·1· · · ··there is absolutely alignment between what
·2· · · ··Steadfast is alleging is happening in the market
·3· · · ··and what we actually saw in evidence at the Agency.
·4· · · · · · · · ··MR. RUSSELL:··Can you scroll up?
·5· ·Q· ··(MR. RUSSELL)··And I just want to show you the
·6· · · ··response because it looks like this complaint was
·7· · · ··actually investigated by Allyson Chirio.
·8· · · · · · · · ··MR. RUSSELL:··You can go up farther.
·9· · · ··Right there.··Okay, there you go.
10· ·Q· ··(MR. RUSSELL) It says at the top there "Patrice and
11· · · ··I looked into the allegations, and based on the
12· · · ··limited information, we did not find any evidence
13· · · ··that the allegations are true.··Below is a summary
14· · · ··of the information."
15· · · · · · · · ··Do you recall that?
16· ·A· ··Yes, sir.··So at that time we investigated that
17· · · ··portion of the complaint and did not find direct
18· · · ··evidence of it at that time.
19· ·Q· ··But you continued to investigate at that point?
20· ·A· ··No, sir.··I believe what happened is we
21· · · ··additionally got Metrc tickets from a licensee that
22· · · ··reiterated this exact claim here, and then we did
23· · · ··have to investigate because we actually had
24· · · ··evidence.··It is our duty as an Agency that if we
25· · · ··get evidence or new evidence that we need to

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·1· · · ··investigate those claims.
·2· · · · · · · · ··MR. RUSSELL:··You can take that down.
·3· ·Q· ··(MR. RUSSELL)··Let me show you what's been marked
·4· · · ··as Exhibit 53.··Do you recognize this email?
·5· ·A· ··Yes, sir, I do.
·6· ·Q· ··Okay.··And so it appears on Sunday, October 24th
·7· · · ··you're emailing -- first of all, Keith Klemm, can
·8· · · ··you -- who is Keith Klemm?
·9· ·A· ··Well, so Keith Klemm works for -- is rather high up
10· · · ··in the ANAB which is an internationally recognized
11· · · ··ISO accrediting body.··I believe I also emailed
12· · · ··PJLA, their director, or I'm not sure what her
13· · · ··title is, as well as A2LA at the behest of my
14· · · ··directors.
15· ·Q· ··And it appears from this email that you're reaching
16· · · ··out to outside experts to get some guidance on ISO
17· · · ··requirements.··Is that correct?
18· ·A· ··No, sir, this is not guidance.··I sent this at the
19· · · ··request of my directors to confirm what I had
20· · · ··already stated to them as a requirement as stated
21· · · ··in ISO 17025 2017.
22· ·Q· ··Why would your directors need you to get
23· · · ··confirmation outside of the CRA?
24· ·A· ··That's a question you'd have to ask them.
25· ·Q· ··Did your directors not believe that you had the

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·1· · · ··expertise to make a determination on the ISO
·2· · · ··requirements?
·3· ·A· ··Again, I think that's a question you'd have to ask
·4· · · ··them.··But, no, I do not believe that's the case.
·5· · · ··If I had to estimate, it's probably because they
·6· · · ··wanted to have it in writing to refute any claims
·7· · · ··by the licensee.
·8· ·Q· ··What kind of claims are you referring to?
·9· ·A· ··Well, I would state that the licensee historically
10· · · ··has been a bit adversarial with the Agency, and if
11· · · ··I had to guess -- again, this is not something that
12· · · ··I directed myself to do -- but if I had to guess,
13· · · ··that would probably be why.
14· ·Q· ··And the purpose of the confirmation was because the
15· · · ··CRA was taking the position that Viridis North and
16· · · ··Viridis Laboratories were not complying with ISO
17· · · ··requirements; is that right?
18· ·A· ··Correct.··So Viridis Laboratories and Viridis
19· · · ··North, by way of showing us what they did have for
20· · · ··their microbial tests, indicated that they were out
21· · · ··of compliance for temperature requirements with the
22· · · ··validated methods, and they were unable to provide
23· · · ··records that indicated that they were in compliance
24· · · ··with the time requirements.··So, therefore, we
25· · · ··needed to make a determination as to whether or not

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·1· · · ··the licensee was, again, following the approved and
·2· · · ··validated SOPs.··And the evidence that they
·3· · · ··provided to us, or the lack thereof, indicated that
·4· · · ··they were not.
·5· ·Q· ··And the issue that you're talking about are logs
·6· · · ··related to incubation times in and out; is that
·7· · · ··right?
·8· ·A· ··So both compliance with the temperature
·9· · · ··requirements, the very specific temperature
10· · · ··requirements of microbial methods, as well as the
11· · · ··very specific time incubation period requirements
12· · · ··of the approved validated methods.
13· ·Q· ··And those incubation times that you're referring
14· · · ··to, the in and out of what's required to track
15· · · ··those, there's no requirement in the SOP, the
16· · · ··statute, or any administrative rule; correct?
17· ·A· ··Well, so what the administrative rule actually
18· · · ··states is that a licensee has to comply with the
19· · · ··SOPs.··In this case the SOPs were essentially, you
20· · · ··know, copy/pasted from the vendor.··And the vendor
21· · · ··states that there has to be a very specific, within
22· · · ··a plus or minus 2-degree temperature, requirement
23· · · ··when incubating these microbial samples as well as
24· · · ··a very specific, I think plus or minus two-hour,
25· · · ··time requirement for the length of time that these

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·1· · · ··samples are incubated.
·2· · · · · · · · ··And what the laboratory demonstrated to
·3· · · ··us is that the temperatures for some of these tests
·4· · · ··were out of range.··And what the laboratory was not
·5· · · ··able to demonstrate to us was that they were
·6· · · ··keeping track in any way of the times specified in
·7· · · ··the vendor's SOP.··So --
·8· ·Q· ··Am I -- go ahead.
·9· ·A· ··So they were unable to prove to us in any way that
10· · · ··they were following their SOP.
11· ·Q· ··So my specific question is the SOP itself did not
12· · · ··have a requirement for keeping any type of log;
13· · · ··correct?
14· ·A· ··Well, in a laboratory space and per ISO, you would
15· · · ··need to keep track of those things --
16· ·Q· ··It's a yes-or-no question really.
17· ·A· ··It's not.··It's actually quite nuanced.··Because
18· · · ··ultimately does it state that they need to keep a
19· · · ··log --
20· ·Q· ··That's the question, yes.··And the answer is no;
21· · · ··right?
22· ·A· ··And, as I stated before, they could keep a
23· · · ··collection of Post-It notes.··They could take --
24· ·Q· ··That wasn't my question.
25· · · · · · · · ··MR. RUSSELL:··Judge, would you direct the

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·1· · · ··witness to answer the question?··I get it she wants
·2· · · ··to make an explanation, and they can do it on
·3· · · ··redirect, but it's a simple yes-or-no question
·4· · · ··whether it's in the SOP or not.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··The answer to the
·6· · · ··question is no; is that correct, Ms. Patterson?
·7· · · · · · · · ··THE WITNESS:··Correct, sir.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··That's all
·9· · · ··you need to tell me.
10· · · · · · · · ··Counsel, go ahead, please.
11· · · · · · · · ··MR. RUSSELL:··Thanks, Judge.
12· ·Q· ··(MR. RUSSELL) So in addition to this Keith Klemm
13· · · ··from ANAB you also reached out to Pat Bird in
14· · · ··relation to these ISO requirements; correct?
15· ·A· ··I believe so.
16· ·Q· ··Okay.··And Pat Bird works for the AOAC; is that
17· · · ··correct?
18· ·A· ··As a consultant, yes.
19· ·Q· ··So he was a consultant for the AOAC?
20· ·A· ··Yes.··I just said "yes."
21· ·Q· ··And you were asking for Patrick Bird's confirmation
22· · · ··on ISO requirements; correct?
23· ·A· ··As it related to this method, yes.
24· ·Q· ··And in addition, in October you also reached out to
25· · · ··the A2LA; is that correct?

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·1· ·A· ··Yes, sir.
·2· ·Q· ··Okay.··And again you were looking for some kind of
·3· · · ··confirmation as to the ISO requirements?
·4· ·A· ··Yes, sir.
·5· ·Q· ··Okay.··And the A2LA is the accrediting body that
·6· · · ··accredits both Viridis North and Viridis
·7· · · ··Laboratories; correct?
·8· ·A· ··Yes, sir.
·9· ·Q· ··So at a minimum you emailed at least three outside
10· · · ··experts to make a determination as to something
11· · · ··that I believe you testified on direct was
12· · · ··inherent; is that correct?
13· ·A· ··I still testify that it is inherent.··Again, I
14· · · ··emailed them to receive written confirmation per
15· · · ··the request of my directors.
16· ·Q· ··Let me show you what's been marked as Exhibit 57.
17· · · · · · · · ··First, do you recognize this?
18· ·A· ··Yes, I do.
19· ·Q· ··Okay.··Is this an accurate depiction of the email
20· · · ··back and forth between you and Desmond Mitchell?
21· ·A· ··Yes, it is.
22· · · · · · · · ··MR. RUSSELL:··Okay.··Where are we at?
23· · · · · · · · ··Your Honor, I would like to move to admit
24· · · ··this as Exhibit 17.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Any objection?

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·1· · · · · · · · ··MS. HUYSER:··All right.··You were
·2· · · ··scrolling pretty quickly.··Can you scroll down for
·3· · · ··me again?··I apologize.
·4· · · · · · · · ··And just permission to ask a question of
·5· · · ··Ms. Patterson, if I may.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Sure.··Go ahead.
·7· · · · · · · · ··MS. HUYSER:··Thank you.
·8· · · · · · · · ··Ms. Patterson, is there -- this starts
·9· · · ··out and it looks like it's a little bit of this
10· · · ··last October 29th at 7:42 response and then another
11· · · ··one.
12· · · · · · · · ··Is this the full complete series of
13· · · ··emails between yourself and Desmond Mitchell, or
14· · · ··did they continue on before or after the snippet
15· · · ··that's in here?
16· · · · · · · · ··THE WITNESS:··I imagine that they would
17· · · ··have continued on before and after.··I would need
18· · · ··to verify that.··But based on what seems to be a
19· · · ··truncated conversation here, that may very well be
20· · · ··the case.
21· · · · · · · · ··MS. HUYSER:··At this point in time I
22· · · ··would object based on this appearing to be a
23· · · ··truncated conversation.··If there's more to this
24· · · ··past that time that seem to actually provide some
25· · · ··type of additional information about this I feel

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·1· · · ··like it would be more complete to admit the entire
·2· · · ··chain.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Well,
·4· · · ··presumably Ms. Patterson has access to her emails,
·5· · · ··so I suppose if there is something more to this
·6· · · ··that is not provided then you can offer that.
·7· · · · · · · · ··Viridis Exhibit 17 is admitted.
·8· · · · · · · · ··MR. RUSSELL:··Thank you, Judge.
10· ·Q· ··(MR. RUSSELL) Ms. Patterson, I just want to ask you
11· · · ··specifically about your response to Mr. Mitchell on
12· · · ··Friday, October 29th, at 7:42 AM.
13· · · · · · · · ··This appears to be a response from you
14· · · ··after receiving responses to your other emails on
15· · · ··the confirmation on the ISO.··It states "The
16· · · ··answers are a little bit more avoidant than the
17· · · ··response from the other two but still supportive of
18· · · ··the case.··It seems as though they allow the labs
19· · · ··to argue with them instead of just following
20· · · ··guidelines as the other third-parties do."
21· ·A· ··Yes, sir.
22· ·Q· ··Okay.··And it's -- in the re line is "Inquiry to
23· · · ··A2LA."
24· · · · · · · · ··So do you know if this is based on your
25· · · ··response from the A2LA?

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·1· ·A· ··This would have been my response, well, clearly to
·2· · · ··Desmond Mitchell likely to an inquiry from him
·3· · · ··related to how A2LA responded, specifically the
·4· · · ··Viridis Laboratories' auditor responded to my
·5· · · ··question about tracking environmental controls in
·6· · · ··the laboratory space.
·7· ·Q· ··So would it be fair to say that you were not in
·8· · · ··agreement with the A2LA's response to you?
·9· ·A· ··No, I simply stated that it seemed a little bit
10· · · ··more avoidant than the direct statement from the
11· · · ··other two.··And I attribute that to the fact that
12· · · ··the responses from the other two accrediting bodies
13· · · ··were, I believe, from presidents or folks that were
14· · · ··more higher up in those accrediting bodies, whereas
15· · · ··this response was elicited from the auditor that
16· · · ··was assigned to Viridis and/or Viridis North.
17· ·Q· ··So the other responses you received were all from
18· · · ··the presidents of the accrediting bodies?
19· ·A· ··I will not state that they were presidents
20· · · ··directly.··I believe they are, but they're
21· · · ··certainly higher up in those accrediting -- those
22· · · ··third-party accrediting bodies.··And those folks
23· · · ··are not involved with, necessarily, the day-to-day
24· · · ··audits, specifically of -- of the situation in
25· · · ··question, if you will.

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·1· ·Q· ··So wouldn't someone that's involved in the
·2· · · ··day-to-day audits have more familiarity with the
·3· · · ··actual workings of a laboratory as opposed to some
·4· · · ··higher-up that was opining on your hypothetical
·5· · · ··question?
·6· ·A· ··Well, no, they should all be equally informed of
·7· · · ··the requirements of ISO 17025.··There should be no
·8· · · ··difference there.··The only thing that would be
·9· · · ··concerning to me would potentially be any bias,
10· · · ··implicit or otherwise, that was potentially present
11· · · ··with someone who was working directly with the
12· · · ··laboratory themselves.
13· ·Q· ··Because as it states here, you wanted to make sure
14· · · ··that they were supportive of your case you were
15· · · ··building; right?
16· ·A· ··I think I said supportive of the case, which I
17· · · ··believe was -- was the question, whether or not
18· · · ··they should be tracking in some form, fashion, that
19· · · ··they are in compliance with the SOPs that they have
20· · · ··approved by the Agency and that have been validated
21· · · ··and peer reviewed.
22· ·Q· ··In October when you were sending out these emails
23· · · ··to these outside experts to confirm your ISO --
24· · · ··your belief on the ISO requirements, you were
25· · · ··building a case against the two Viridis labs for an

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·1· · · ··eventual recall; is that right?
·2· ·A· ··I was collecting information related to what would
·3· · · ··eventually be a recall, yes.
·4· ·Q· ··Okay.··So the plan was to collect information,
·5· · · ··confirm information, build your case, because you
·6· · · ··thought you needed to build your case -- I think
·7· · · ··you testified that you had an adverse relationship
·8· · · ··with the lab, so you thought you had to have some
·9· · · ··kind of backup information; is that right?
10· ·A· ··No, sir.··What I stated is that the lab is
11· · · ··historically adversarial with the Agency, and so
12· · · ··that my directors wanted me to obtain information
13· · · ··in writing from various industry experts.
14· · · · · · · · ··And I apologize, that did seem like a bit
15· · · ··of a compound question.··Would you revisit the
16· · · ··other questions for me?
17· ·Q· ··You answered the question.··I'm fine.··Thank you.
18· ·A· ··Thank you.
19· · · · · · · · ··MR. RUSSELL:··You can take that down.
20· ·Q· ··(MR. RUSSELL) So you testified as part of making a
21· · · ··determination on the microbial issues or the
22· · · ··aspergillus issues specifically you made
23· · · ··determinations as to the fail rates for I believe
24· · · ··all of the laboratories; is that correct?
25· ·A· ··We looked at the data, the aggregate data, from all

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·1· · · ··of the laboratories in Metrc, yes, to assess an
·2· · · ··average fail rate for all laboratories.
·3· ·Q· ··So please tell me how you -- how you went about
·4· · · ··gathering that information.
·5· ·A· ··As in physically collecting it from Metrc?
·6· ·Q· ··Correct.··Yes.··How do you -- how is that done?
·7· ·A· ··So our data analysts write what I anticipate to be
·8· · · ··some kind of code and input that code into Metrc in
·9· · · ··order to pull a specific subset of data down,
10· · · ··essentially from Metrc, so that we can view the
11· · · ··data in -- in its more limited form.
12· · · · · · · · ··MR. RUSSELL:··Judge, can we take a
13· · · ··15-minute break before I introduce my next exhibit?
14· · · · · · · · ··JUDGE GOLDSTEIN:··Sure.··We can go off
15· · · ··for a bit.··We'll go 17 minutes, till 2:30.··Okay?
17· · · · · · · · ··JUDGE GOLDSTEIN:··2:13.··Thank you.
18· · · · · · · · ··(Break taken at 2:13 PM)
19· · · · · · · · ··(Break concluded at 2:32 PM)
20· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··We are back
21· · · ··on the record in the matter of Viridis
22· · · ··Laboratories, LLC, and Viridis North, and the
23· · · ··Cannabis Regulatory Agency, consolidated Docket
24· · · ··Numbers 21-029794, et al.··The time is 2:32 PM.
25· · · · · · · · ··All right.··Ms. Hunt-Scully and

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·1· · · ··Ms. Huyser, did you have a chance to talk about the
·2· · · ··transcript issue during the break?··If not, that's
·3· · · ··okay, we can just keep going.
·4· · · · · · · · ··MS. HUNT-SCULLY:··Yes, we did,
·5· · · ··Your Honor.··And if the tribunal is comfortable
·6· · · ··with that procedure, then we'd leave it to the
·7· · · ··tribunal's discretion.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Well, if
·9· · · ··counsel for Viridis, you're comfortable with it, we
10· · · ··can adopt the one --
12· · · · · · · · ··JUDGE GOLDSTEIN:··-- Ms. Duda's as the
13· · · ··official record.··I'm still going to record the
14· · · ··proceedings as a backup.··I will indicate in the
15· · · ··written decision in this case, if not in an order
16· · · ··prior to that point, the specific administrative
17· · · ··rule that I would rely on in adopting Ms. Duda's
18· · · ··transcript as the official record.··Okay?
19· · · · · · · · ··And please get us copies of that as they
20· · · ··are produced.··Specifically in this case, it's
21· · · ··drawing a lot of attention currently and we're
22· · · ··getting FOIA requests, so we must comply.··Okay?
23· · · · · · · · ··MR. RUSSELL:··Yes, Judge.··We'll get
24· · · ··those out today, the ones that we have in our
25· · · ··possession at this time.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Very good.
·2· · · ··Thank you.
·3· · · · · · · · ··All right.··Counsel, you may continue if
·4· · · ··there's nothing further.··Go ahead.
·5· · · · · · · · ··MR. RUSSELL:··Thanks, Your Honor.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you.
·7· ·Q· ··(MR. RUSSELL) Ms. Patterson, I'm going to show you
·8· · · ··what's been marked as Exhibit 83A.
·9· · · · · · · · ··MR. RUSSELL:··Can you scroll down?
10· ·Q· ··(MR. RUSSELL)··And I don't have a lot of questions
11· · · ··on this.··I believe that this is the data from
12· · · ··Metrc that you used to determine aspergillus fail
13· · · ··rates, but I just wanted you to review this and
14· · · ··tell me if that was correct.
15· ·A· ··Without looking at the entirety of the data in the
16· · · ··documents, I can't be certain.··It does state
17· · · ··aspergillus results all, so this is certainly a
18· · · ··review of aspergillus results reported in Metrc,
19· · · ··absolutely.
20· ·Q· ··And so -- and that's fair.··I understand it's a lot
21· · · ··of data.··I'm not trying to trick you in any way.
22· · · ··But if we scroll over to the right, on the bottom
23· · · ··right there I think we can show dates, and maybe
24· · · ··that would be helpful to you.
25· · · · · · · · ··MR. RUSSELL:··There you go.··Please

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·1· · · ··scroll up then.
·2· ·Q· ··(MR. RUSSELL) If you look at that -- I believe
·3· · · ··it's -- oh, I believe that gives a date range.
·4· ·A· ··Yes, sir, that is -- that is the date that the
·5· · · ··testings occurred.
·6· ·Q· ··Okay.··So to confirm, then, my understanding that
·7· · · ··the date range would have been August 12th, 2021,
·8· · · ··through October 18th, 2021; is that correct?
·9· ·A· ··Is that what's listed under the test dates there?
10· ·Q· ··I believe it is.··And I'm happy to show you any
11· · · ··part of it or make it bigger if it helps.
12· ·A· ··No, I believe that.··So any test date that's
13· · · ··reported there is an accurate test date of whenever
14· · · ··those samples were entered in Metrc.
15· ·Q· ··Okay.
16· · · · · · · · ··MR. RUSSELL:··And so, Judge, I would move
17· · · ··to admit this as Exhibit 18.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Thank you.
20· · · · · · · · ··I'm not finding this initially.··Is this
21· · · ··under one of the dep exhibits by chance?
22· · · · · · · · ··MR. RUSSELL:··No.··No.··It's 83A.
23· · · · · · · · ··JUDGE GOLDSTEIN:··I go from -- the
24· · · ··initial list goes from 74 to 76 which looks to be a
25· · · ··slide.··And then 86 is the next numbered exhibit.

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·1· · · · · · · · ··MR. SCHUMACHER:··Look at the exhibits
·2· · · ··that were sent.
·3· · · · · · · · ··MR. RUSSELL:··Your Honor, I think it was
·4· · · ··probably with the exhibits that were resent
·5· · · ··Batesed.··We can resend this again if it doesn't
·6· · · ··download.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··I'm not seeing it.··I'm
·8· · · ··not seeing an 83?··Is that what you said?··83A?
·9· · · · · · · · ··MR. RUSSELL:··83A, yes.
10· · · · · · · · ··MR. SCHUMACHER:··It was resent this
11· · · ··morning at 11 AM.
12· · · · · · · · ··MR. RUSSELL:··It was resent this morning,
13· · · ··Your Honor, at 11 AM.
14· · · · · · · · ··JUDGE GOLDSTEIN:··And you sent it to the
15· · · ··JA mailbox; correct?
16· · · · · · · · ··MR. SCHUMACHER:··JA -- I can't read that.
17· · · · · · · · ··MR. RUSSELL:··Yes, that's correct.
18· · · · · · · · ··You can take that down.
19· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··I will have
20· · · ··to send an email.
21· · · · · · · · ··This is being marked as -- well, it had
22· · · ··to have come through if you just sent it this
23· · · ··morning.··This is 18; is that correct?
24· · · · · · · · ··MR. RUSSELL:··Correct.

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·3· ·Q· ··(MR. RUSSELL) Now I'm going to show you what's been
·4· · · ··marked as Exhibit 83B.
·5· · · · · · · · ··MR. RUSSELL:··Can you make it a little
·6· · · ··bigger?
·7· ·Q· ··(MR. RUSSELL) Ms. Patterson, do you recognize this
·8· · · ··document?
·9· ·A· ··Yes, sir.
10· ·Q· ··Okay.··And how do you recognize it?
11· ·A· ··This is aspergillus data related to Viridis.
12· ·Q· ··Okay.··And was this a document that you put
13· · · ··together?
14· ·A· ··It may have been me that put it together,
15· · · ··absolutely.
16· ·Q· ··Okay.··And so am I right that you would have taken
17· · · ··data from the first list that we looked at for
18· · · ··Metrc data to arrive at this?··Is that right?
19· ·A· ··I would have to look at the data specifically in
20· · · ··order to tell you what that correlation is.
21· ·Q· ··So you can't testify necessarily that the data I
22· · · ··showed you on the first sheet was what was used for
23· · · ··these calculations; correct?
24· ·A· ··Sir, I'd have to look at the data contained within.
25· · · ··I'd have to look at the -- what was translated over

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·1· · · ··here in order to confirm that information.
·2· ·Q· ··You would have used some kind of supporting data to
·3· · · ··come up with these fail rates; is that right?
·4· ·A· ··Absolutely.
·5· ·Q· ··And that data would have come from Metrc; is that
·6· · · ··right?
·8· ·Q· ··And if I told you that the metadata on this
·9· · · ··document shows it was created on November 16th,
10· · · ··would you have any reason to disagree with that?
11· ·A· ··No.
12· ·Q· ··Okay.··So if I told you that it appears by
13· · · ··comparing Viridis North and Viridis Laboratories'
14· · · ··data that the date range for this compilation is
15· · · ··August 12th, 2021, to November 16th, 2021, would
16· · · ··you have any reason to disagree with that?
17· ·A· ··I can't speak to that without seeing what data was
18· · · ··used to create this.··Just because a document was
19· · · ··created later in time does not necessarily indicate
20· · · ··that it was using any sort of different data set.
21· ·Q· ··So looking at this exhibit, the -- I'm looking at J
22· · · ··which is the far-right column.
23· · · · · · · · ··MS. HUYSER:··Your Honor, at this point in
24· · · ··time I'm going to object to the use of this exhibit
25· · · ··or at this point I know it hasn't been asked for

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·1· · · ··admission, but she has testified that she can't
·2· · · ··verify, is not familiar with being able to say
·3· · · ··where the data came from without originally --
·4· · · ··looking at the original sub -- full categories.··I
·5· · · ··don't think it's fair that we ask her questions
·6· · · ··about something she has said she can't identify.
·7· · · · · · · · ··MR. RUSSELL:··Your Honor, if I may
·8· · · ··respond, she testified that she recognized the data
·9· · · ··and that this was put together as part of the
10· · · ··recall.··Now, she did testify she can't be sure on
11· · · ··the date range of this, but she did recognize this,
12· · · ··this document.··And this was information that's
13· · · ··been provided to us by the CRA.
14· · · · · · · · ··JUDGE GOLDSTEIN:··Further response?
15· · · · · · · · ··MS. HUYSER:··Well, I understand that she
16· · · ··said she recognized the original one.··I didn't
17· · · ··believe that she recognized that this was a subset
18· · · ··or how much was pulled out or where it came from
19· · · ··without comparing the actual data.
20· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Remind the
21· · · ··tribunal what this chart represents again.
22· · · · · · · · ··MR. RUSSELL:··It represents, I believe,
23· · · ··calculated fail rates that were put together by the
24· · · ··CRA prior to the recall.··And this goes right to
25· · · ··aspergillus -- alleged aspergillus fail rates.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··And you
·2· · · ··recognize this document, Ms. Patterson?
·3· · · · · · · · ··THE WITNESS:··I do recognize the data,
·4· · · ··sir, but I do want to clarify that this data was
·5· · · ··not used as the basis of the recall either.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··How do you know that?
·7· · · · · · · · ··THE WITNESS:··Because what was used as
·8· · · ··the basis of the recall is the fact that the
·9· · · ··licensee was not shown to be following their
10· · · ··standard operating procedures as they were approved
11· · · ··by the Agency.
12· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··I'll allow
13· · · ··the document.··This is also given whatever weight
14· · · ··it's worth.
15· · · · · · · · ··I don't think that I have this one
16· · · ··either, Counsel.··You say you resubmitted several
17· · · ··this morning, the ones I said I don't have?
18· · · · · · · · ··MR. RUSSELL:··Correct, Your Honor.
19· · · · · · · · ··MR. SCHUMACHER:··It was in a share file
20· · · ··link.
21· · · · · · · · ··MR. RUSSELL:··It was in a share file
22· · · ··link.
23· · · · · · · · ··So we'll move for this to be Exhibit 19,
24· · · ··then, Your Honor.

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·1· · · ··admitted.··I'm sorry, Viridis Exhibit 19.
·3· ·Q· ··(MR. RUSSELL) Ms. Patterson, I was starting to ask
·4· · · ··you about column J.··And I know you just testified
·5· · · ··that these fail rates weren't the rationale behind
·6· · · ··the recall.··And I don't think I asked that
·7· · · ··question.··My understanding is these were fail
·8· · · ··rates that were calculated prior to the recall,
·9· · · ··though.
10· · · · · · · · ··Am I wrong that you did calculate fail
11· · · ··rates prior to the recall?
12· ·A· ··I believe that is correct, yes, sir.··And given the
13· · · ··date range you specified, that does make sense.
14· ·Q· ··Okay.··So -- and again, I'm not trying to trick
15· · · ··you.··If some of these weights or these percent
16· · · ··rates don't seem accurate, please tell me.
17· ·A· ··Like I said, sir, I can't speak to that without
18· · · ··reviewing the data.
19· ·Q· ··But your testimony is that you --
20· · · · · · · · ··MS. HUNT-SCULLY:··I'm sorry to interrupt,
21· · · ··but I'm going to lodge an objection at this point.
22· · · ··Any evidence or testimony about circumstances of
23· · · ··the recall that's not included in any of the
24· · · ··superseding formal complaints that the CRA has
25· · · ··filed against Viridis, and in the disruption

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·1· · · ··complaint that Viridis filed against the Agency
·2· · · ··there's a specific footnote in it that Viridis
·3· · · ··acknowledges that a recall is not an investigative
·4· · · ··procedure, and so I think it's just getting too far
·5· · · ··afield at this point, especially since any
·6· · · ··allegations or anything about the circumstances of
·7· · · ··the recall that are not contained in the
·8· · · ··superseding formal complaints and there's a
·9· · · ··footnote in Viridis's complaint that it doesn't
10· · · ··apply.
11· · · · · · · · ··MR. RUSSELL:··Judge, may I respond?
12· · · · · · · · ··JUDGE GOLDSTEIN:··Yes, go ahead.
13· · · · · · · · ··MR. RUSSELL:··Judge, this information
14· · · ··isn't offered for the rationale or anything to do
15· · · ··with the recall, I was simply trying to establish a
16· · · ··time frame of when this was put together.
17· · · · · · · · ··Obviously, the court is -- the tribunal
18· · · ··is aware that the -- the superseding complaint
19· · · ··against the two Viridis labs includes not just
20· · · ··potency in foreign matter but also microbial
21· · · ··including aspergillus.··This goes to that
22· · · ··specifically as to the fail rates because, as
23· · · ··Ms. Patterson testified, they're claiming that
24· · · ··there was these anomalies.··And she's also
25· · · ··testified earlier that Viridis, their fail rates

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·1· · · ··were much lower than the other laboratories.··This
·2· · · ··is completely pertinent.
·3· · · · · · · · ··I'm not trying to make a case of whether
·4· · · ··the recall should happen or shouldn't have
·5· · · ··happened.··This goes specifically to the defense on
·6· · · ··the superseding complaint as it relates to that.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··I've heard
·8· · · ··enough.··Thank you.··The superseding complaints do
·9· · · ··allege irregularities in the microbial testing
10· · · ··including aspergillus.··The document is relevant.
11· · · · · · · · ··MR. RUSSELL:··I believe it's already been
12· · · ··admitted as Exhibit 19.
13· · · · · · · · ··JUDGE GOLDSTEIN:··The objection is
14· · · ··overruled.
15· · · · · · · · ··MR. RUSSELL:··Go to sheet 2.··It would be
16· · · ··gray sheet 2.··No, no, no.··Yeah, there you go.
17· · · · · · · · ··Can you make it a little bigger?
18· ·Q· ··(MR. RUSSELL) Ms. Patterson, do you recognize this
19· · · ··document?
20· ·A· ··In that this is clearly data related to Metrc, I
21· · · ··assume that this is part of the same document and
22· · · ··wasn't something that was added later.
23· ·Q· ··Do you recall at some point coming up with an
24· · · ··industry average and a median for aspergillus fail
25· · · ··rates?

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·1· ·A· ··Yes, I believe so.
·2· ·Q· ··Okay.··And do you know -- would you have been the
·3· · · ··person that calculated those averages?
·4· ·A· ··It may have been me.··It may have been the LSS
·5· · · ··team.··It would have certainly been any number of
·6· · · ··us.
·7· ·Q· ··But is it true you testified earlier that one of
·8· · · ··the things you looked at as it relates to whether
·9· · · ··Viridis's testing was an anomaly or there was an
10· · · ··issue was the industry fail rate and where they
11· · · ··fell, where their labs fell as far as their percent
12· · · ··of fails; is that correct?
13· ·A· ··Well, yes.··But I believe that this was more
14· · · ··closely associated with the recall.··And, again,
15· · · ··without looking at the data to figure out what was
16· · · ··attributed where, I'm not able to make that
17· · · ··determination.··However, based on what I'm seeing
18· · · ··in columns I and J, that makes me believe that this
19· · · ··was data that was calculated after the recall was
20· · · ··in effect.
21· · · · · · · · ··MR. RUSSELL:··Can you go so she can see
22· · · ··the top?··Okay.··There you go.
23· ·Q· ··(MR. RUSSELL) So would you agree with me that the
24· · · ··information in column B represents percent of total
25· · · ··samples tested that failed from whatever time frame

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·1· · · ··this is for these laboratories?
·2· ·A· ··Yes.
·3· ·Q· ··Okay.··And would you agree with me that there was a
·4· · · ··determine based on this that the industry average
·5· · · ··of fails was 9.43 percent?
·6· ·A· ··It appears that that relates specifically to
·7· · · ··aspergillus failures.··So that data may have been
·8· · · ··pulled from elsewhere.
·9· · · · · · · · ··As column B states, this says percent of
10· · · ··total samples tested that failed and doesn't
11· · · ··attribute any specificity to aspergillus.··But yes.
12· ·Q· ··Okay.··Just so I'm clear, then, and I think that's
13· · · ··right, that this is related specifically to
14· · · ··aspergillus fails, not any other microbials; is
15· · · ··that right?
16· ·A· ··Where it says aspergillus failures as you
17· · · ··questioned about industry average, yes, sir, that
18· · · ··states 9.4 percent.
19· ·Q· ··Okay.··And you're taking that when you go down B
20· · · ··past the numbers where it says "aspergillus fails"
21· · · ··and then below that are microbial overall failures;
22· · · ··correct?
23· ·A· ··Yes, sir.
24· ·Q· ··Okay.··So if you look at columns -- I guess the
25· · · ··first one says testing facilities, so 2 through 13,

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·1· · · ··those were -- in column A those would represent the
·2· · · ··different safety compliance facilities; correct?
·3· · · ··Or some of them?
·4· ·A· ··Yes, sir.
·5· ·Q· ··Okay.··And then B would represent the percentage of
·6· · · ··fails for each of those; correct?··Their averages?
·7· ·A· ··Yes.··And I can't attribute what those fails are
·8· · · ··necessarily related to as it is unclear.
·9· ·Q· ··Right.··Okay.··So if you take the averages in B, so
10· · · ··if you take 2 through 13 and you add them up and
11· · · ··you divide them by that number, you get an average
12· · · ··of 9.43 is the average.
13· · · · · · · · ··So it appears that the CRA took the
14· · · ··averages from each laboratory and just averaged the
15· · · ··averages; is that correct?
16· ·A· ··In this particular spreadsheet, yes, sir, I would
17· · · ··agree that appears to be correct.
18· ·Q· ··Okay.··So the CRA failed to use any type of
19· · · ··weighted average when determining the average fail
20· · · ··rate for aspergillus fails; is that correct?
21· ·A· ··As it relates to this specific spreadsheet and the
22· · · ··calculations contained therein, yes, that is
23· · · ··correct.
24· ·Q· ··Okay.··And would you agree with me that that
25· · · ··wouldn't be a good way of determining an average

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·1· · · ··fail rate unless you were looking to arrive at a
·2· · · ··certain answer?
·3· ·A· ··No, this is simply the calculation of an average
·4· · · ··and a median.
·5· ·Q· ··Okay.··So, for instance, let's take The Spott.··If
·6· · · ··they had only two tests and they failed one, their
·7· · · ··average would be 50 percent; correct?
·9· ·Q· ··Okay.··And then if you had a laboratory that had a
10· · · ··thousand and they failed one, it would be a lot
11· · · ··lower; correct?
12· ·A· ··Yes, sir, that is correct.
13· ·Q· ··Okay.··So when you just take the averages like
14· · · ··that, that 50 percent for the two tests is given
15· · · ··the same weight as the 1,000 tests from another
16· · · ··laboratory; correct?
17· ·A· ··As it relates to this particular calculations, yes,
18· · · ··that is correct.
19· ·Q· ··Okay.··So this -- this spreadsheet here doesn't
20· · · ··take into account at all the number of tests that a
21· · · ··specific laboratory actually conducted, it's just
22· · · ··the averages averaged; is that right?
23· ·A· ··Yes.··This particular spreadsheet that is the case.
24· · · ··But I do believe the rest of the data that you were
25· · · ··looking at seemed to have some sort of weighted

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·1· · · ··averages on them.··But again, I can't speak to how
·2· · · ··the data all correlates to one another without
·3· · · ··actually looking at the data itself.
·4· ·Q· ··And if I look at -- which are in red, I believe --
·5· · · ··Viridis North and Viridis Laboratories, their two
·6· · · ··averages are actually averaged together in this; is
·7· · · ··that correct?··Is that what this in D is?
·9· ·Q· ··Okay.··So these are two separate laboratories.
10· · · ··One's in Lansing and one's in Bay City; correct?
11· ·A· ··Yes, they're two separate laboratories.··Same
12· · · ··ownership, same standard operating procedures.
13· ·Q· ··Okay.··Regardless if they're the same standard
14· · · ··operating procedures and the same owners, they do
15· · · ··have different customer bases; correct?
16· ·A· ··I assume that they have at least some overlap and
17· · · ··some differing customers, yes, sir.
18· ·Q· ··And would it be fair to say that there are some
19· · · ··customers that have higher fail rates than other
20· · · ··customers based on how their facilities are?
21· ·A· ··Certainly.··But I would also assert that in an
22· · · ··industry like this as large as it is, typically
23· · · ··you're going to see averages that are similar to
24· · · ··one another.··There should be some sort of
25· · · ··normalization in data, particularly when you're

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·1· · · ··comparing two laboratories that are using the same
·2· · · ··SOPs, often share staff, things of that nature.
·3· ·Q· ··In addition to the industry average that you
·4· · · ··calculated just using these averages here on this
·5· · · ··sheet, there's a median, the 7.4 percent.··And that
·6· · · ··median is taken from the averages as well; is that
·7· · · ··correct?
·8· ·A· ··I don't believe -- well, yes, if by averages you're
·9· · · ··referring to the percent of total samples tested
10· · · ··that failed in column B.
11· ·Q· ··Right.··So, again, the -- there was no weighted
12· · · ··average that was used to arrive at the median; is
14· ·A· ··As it relates to this particular spreadsheet, no,
15· · · ··it doesn't appear so.
16· ·Q· ··Okay.··And so then Viridis North which it appears
17· · · ··pursuant to this spreadsheet had an almost
18· · · ··5 percent fail rate and then Viridis Laboratories
19· · · ··had a much lower 0.78 percent, if you look below
20· · · ··the average failures it has them at 2.9 percent,
21· · · ··and that's the number that's used for Viridis as
22· · · ··one single percent; is that right?
23· ·A· ··In that combined portion there, yes, sir, that is
24· · · ··correct.
25· · · · · · · · ··MR. RUSSELL:··Okay.··You can take that

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·1· · · ··down.
·2· ·Q· ··(MR. RUSSELL) Now I'm going to show you what's been
·3· · · ··marked as Exhibit 98A.··Do you recognize this
·4· · · ··document?
·5· ·A· ··Only in the fact that it appears to be Metrc data.
·6· ·Q· ··Okay.··Do you know if you had any part in putting
·7· · · ··this data together, assembling this?
·8· ·A· ··Again, I may have.··It may have been the LSS team.
·9· ·Q· ··Okay.··Do you know what the purpose of this
10· · · ··compilation is or was?
11· ·A· ··No, sir, I do not.
12· ·Q· ··Ms. Patterson, would you agree that this document
13· · · ··looks at total microbial fails?
14· · · · · · · · ··MS. HUYSER:··Your Honor, I'm going to
15· · · ··object at this point in time.··She said that she
16· · · ··believes it looks like Metrc data but she's not
17· · · ··familiar with its content or sure of its purpose.
18· · · · · · · · ··MR. RUSSELL:··Your Honor, she also
19· · · ··testified that she may have put the document
20· · · ··together.··So, I mean, the two aren't really --
21· · · ··that doesn't really make sense.
22· · · · · · · · ··MS. HUYSER:··But she also testified she
23· · · ··may not have.··So, I mean, that goes on both sides
24· · · ··of it.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Ms. Patterson, do you

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·1· · · ··recognize what this document is generally?
·2· · · · · · · · ··THE WITNESS:··I recognize that it is
·3· · · ··Metrc data and the title states Microbial Flower
·4· · · ··Tests.··I do not know what purpose it was used for
·5· · · ··or where it was sourced from in terms of what
·6· · · ··specific data was used other than the fact that it
·7· · · ··is from Metrc.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··That's all
·9· · · ··you know about it?
10· · · · · · · · ··THE WITNESS:··Yes, sir.
11· · · · · · · · ··JUDGE GOLDSTEIN:··Can you draw any
12· · · ··conclusions from it?
13· · · · · · · · ··THE WITNESS:··It appears that there are
14· · · ··passing and failing tests as well as total tests.
15· · · ··Without looking at columns J and K, I can't
16· · · ··necessarily tell what any conclusions were based on
17· · · ··that, though.
19· · · · · · · · ··Counsel, what's the relevance of the
20· · · ··document, given the witness's response?
21· · · · · · · · ··MR. RUSSELL:··Well, the -- the 10 percent
22· · · ··and the 5 percent in column L go back -- are
23· · · ··transposed from the document previously.··This goes
24· · · ··to the microbial fails and how they calculated
25· · · ··these.

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·1· · · · · · · · ··I think this is clearly relevant.··If
·2· · · ··Ms. Patterson is not the person to testify about
·3· · · ··this, which I find -- I don't think that's
·4· · · ··accurate, I guess I'd like to know who that is.
·5· · · · · · · · ··This is, again, information that's
·6· · · ··provided by the CRA.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Ms. Patterson, you say
·8· · · ··this is from Metrc data; correct?··Looks to be
·9· · · ··Metrc data?
11· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So let's go
12· · · ··through the document.
13· · · · · · · · ··On the left side here we have a testing
14· · · ··facility.··It looks like there's a number of
15· · · ··testing facilities named here including Viridis;
16· · · ··correct?
17· · · · · · · · ··THE WITNESS:··Correct.
18· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··And then
19· · · ··the testing -- there's an insert box here that's
20· · · ··kind of in the way of everything.··I'm not sure
21· · · ··what that is doing there, but -- I don't know if it
22· · · ··can be removed or not.
23· · · · · · · · ··MR. RUSSELL:··Can you remove that?
25· · · · · · · · ··Okay.··And the next facility, the license

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·1· · · ··number of the testing lab; right?
·2· · · · · · · · ··THE WITNESS:··Yes, sir.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··And we have a number
·4· · · ··of -- we have some numbers here.··Passing tests.
·5· · · ··The number of passing tests for what, microbial
·6· · · ··flower tests?
·7· · · · · · · · ··THE WITNESS:··Yes, that is what it
·8· · · ··appears to be.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Can you
10· · · ··speak up a little bit, please?
11· · · · · · · · ··THE WITNESS:··Yes, sir, that is what it
12· · · ··appears to be in column C, the number of passing
13· · · ··tests for microbials on flower.
14· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··D is failing
15· · · ··tests?
17· · · · · · · · ··JUDGE GOLDSTEIN:··Flower tests; right?
18· · · · · · · · ··And what does all this mean?
19· · · · · · · · ··THE WITNESS:··So the passing tests would
20· · · ··be related to the total number of microbial flower
21· · · ··tests that passed testing based on our requirements
22· · · ··and rule.··Column D would be the number that failed
23· · · ··testing.··Column E would be the total number of
24· · · ··flower tests that were conducted by each of those
25· · · ··licenses.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··And that looks
·2· · · ··like we have some listed in another.··F, G, H, I,
·3· · · ··J.··What do all those columns mean?
·4· · · · · · · · ··THE WITNESS:··So F, G, and H appear to be
·5· · · ··aggregates.··So based on what is listed in the
·6· · · ··Excel document title, it appears -- let me do the
·7· · · ··math really quickly.··It appears that the values
·8· · · ··from two licenses, if the licensee held more than
·9· · · ··one license, were added together, aggregated into
10· · · ··passing and failing tests as well as the total
11· · · ··flower tests.
12· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Now,
13· · · ··Counsel, given the witness's knowledge of the
14· · · ··document, ask questions about it so I can determine
15· · · ··whether it's relevant and admissible.
16· · · · · · · · ··MR. RUSSELL:··Okay.
17· ·Q· ··(MR. RUSSELL) Ms. Patterson, at some point did the
18· · · ··CRA make a determination on microbial fail rates
19· · · ··for the different laboratories in the state of
20· · · ··Michigan?
21· ·A· ··We -- we did, it appears, used the data to
22· · · ··calculate those values.··I don't know if you are
23· · · ··able to click on J or K, any of those columns, to
24· · · ··confirm that.··So that would be the number of
25· · · ··failing tests divided by the number of total flower

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·1· · · ··tests which would result in the percent failure.
·2· · · ··And then if you go over one --
·3· ·Q· ··To K?
·4· ·A· ··Yes, sir.··Thank you.··Would just be column J then
·5· · · ··multiplied by 100 to get a total percentage.
·6· ·Q· ··So similar to the prior spreadsheet except that was
·7· · · ··for -- specifically for aspergillus, this would be
·8· · · ··for microbials; correct?
·9· ·A· ··Yes, sir, that does appear to be the case based on
10· · · ··the title.
11· ·Q· ··Okay.··And, again, in K there would have been --
12· · · ··those would have been the averages of failures for
13· · · ··the laboratories; correct?
14· ·A· ··Correct, based on total number of tests performed.
15· ·Q· ··Okay.··And then the CRA used that to come up with
16· · · ··an industry average; is that correct?
17· ·A· ··Based on the prior Excel document that you showed
18· · · ··me, yes, sir, that is correct.
19· ·Q· ··Okay.··And so wouldn't it be fair to say that the
20· · · ··total percent or the average of the industry is
21· · · ··used by the CRA to make a determination of whether
22· · · ··a lab falls way below that or way above that?
23· ·A· ··In these particular spreadsheets and in this
24· · · ··limited scope of data analysis, yes, sir, that is
25· · · ··correct.

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·1· · · · · · · · ··MR. RUSSELL:··Okay.··So, Your Honor, I
·2· · · ··think that's -- she just testified exactly what I
·3· · · ··expected her to testify to, and I don't really need
·4· · · ··much more from her than that.··Someone else will
·5· · · ··testify to this too.··But this does show the
·6· · · ··microbial percentages, how they arrived at it.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Ms. Patterson, did CRA
·8· · · ··use this documentation in support of the
·9· · · ··allegations in this complaint?
10· · · · · · · · ··THE WITNESS:··This was used as part of
11· · · ··the complaint in terms of investigation.··However,
12· · · ··the evidence that we found on site further
13· · · ··evidenced our concerns that the licensee was not
14· · · ··following their SOPs.
15· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··That's not my
16· · · ··question.
17· · · · · · · · ··Is this -- is this documentation
18· · · ··something that CRA relied on to support the
19· · · ··complaint?
20· · · · · · · · ··THE WITNESS:··I don't believe so, no.
21· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··You don't
22· · · ··believe so.··And why do you think that?
23· · · · · · · · ··THE WITNESS:··Because in order to support
24· · · ··our complaint, what we witnessed on site, the fact
25· · · ··that the laboratory was out of specification with

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·1· · · ··their temperature and was unable to provide proof
·2· · · ··of timekeeping with these methods and also out of
·3· · · ··alignment with their quality management, that was
·4· · · ··the basis of our complaints.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So this
·6· · · ··information, though, did this -- does this in your
·7· · · ··view confirm or negate the allegations in the
·8· · · ··complaint?
·9· · · · · · · · ··THE WITNESS:··I believe that it confirms
10· · · ··the allegations in the complaint.
11· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So it is
12· · · ··documentation you would rely on to confirm your
13· · · ··suspicions in what you saw or maybe verify what you
14· · · ··saw?
15· · · · · · · · ··THE WITNESS:··I believe that this could
16· · · ··verify what we saw, yes.
17· · · · · · · · ··JUDGE GOLDSTEIN:··Right.··The document is
18· · · ··relevant.
19· · · · · · · · ··Are we offering it, Counsel?
20· · · · · · · · ··MR. RUSSELL:··Yes, Your Honor.··This
21· · · ··would be Exhibit 20, Your Honor.
22· ·Q· ··(MR. RUSSELL) And, Ms. Patterson, I just want to be
23· · · ··clear.··The averages, again, these are not weighted
24· · · ··averages; correct?
25· · · · · · · · ··JUDGE GOLDSTEIN:··One minute, Counsel.··I

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·1· · · ··haven't --
·2· · · · · · · · ··MR. RUSSELL:··Oh, I'm sorry.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··-- reviewed the
·4· · · ··document yet.
·5· · · · · · · · ··This is what, 98A?
·6· · · · · · · · ··MR. RUSSELL:··Yes, Your Honor.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Is this 96 or 98A?
·8· · · · · · · · ··MR. RUSSELL:··98A, Your Honor.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··It was part of a dep
10· · · ··exhibit or part of the initial list?
11· · · · · · · · ··MR. RUSSELL:··Initial list, Your Honor.
12· · · · · · · · ··JUDGE GOLDSTEIN:··Is that something you
13· · · ··sent over today?
15· · · · · · · · ··JUDGE GOLDSTEIN:··And I just got an email
16· · · ··saying they checked the inbox as well as the junk
17· · · ··folder and don't see anything.
18· · · · · · · · ··Are they sending -- are they sending it
19· · · ··to moahr-ga@michigan.gov?
21· · · · · · · · ··JUDGE GOLDSTEIN:··M-O-A-H-R hyphen
22· · · ··G-A@Michigan.gov?
23· · · · · · · · ··MR. RUSSELL:··Yes.
24· · · · · · · · ··MR. SCHUMACHER:··Yes.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah.··They're saying

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·1· · · ··they don't have it.··So we'll have to work on
·2· · · ··getting that.··I'm not certain why it's not
·3· · · ··working.
·4· · · · · · · · ··This has been marked as what?··Twenty?
·5· · · · · · · · ··MR. RUSSELL:··20, Your Honor.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Viridis Exhibit 20 is
·9· ·Q· ··(MR. RUSSELL) Ms. Patterson, I think I was starting
10· · · ··to ask you if you -- if you calculated the averages
11· · · ··again without using a weighted average.··Is that
12· · · ··correct?
13· ·A· ··As we're referring back to the prior document and
14· · · ··this, assuming that those are, in fact, fact
15· · · ··related, yes, those were not calculated using a
16· · · ··weighted average.
17· ·Q· ··Okay.··And does the -- do you know if the 5.06, is
18· · · ··that -- is that the average that was calculated for
19· · · ··the Viridis laboratories?
20· ·A· ··Would you be able to click on that for me to
21· · · ··confirm that information?
22· ·Q· ··(Complying)
23· ·A· ··Yes, sir, that appears to be correct.
24· ·Q· ··Okay.··And then the 10.598, is that what you
25· · · ··calculated as the industry average?

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·1· ·A· ··Yes, sir.
·2· ·Q· ··I think we're going to have one more or two more
·3· · · ··documents.
·4· · · · · · · · ··I'm showing you what's been marked as
·5· · · ··Exhibit 98B.
·6· · · · · · · · ··MR. RUSSELL:··Can you scroll down so she
·7· · · ··can see that?
·8· · · · · · · · ··MS. HUYSER:··Can we get the red box off
·9· · · ··again if that's possible, please?
10· · · · · · · · ··MR. RUSSELL:··Sure.··I apologize, we're
11· · · ··having a little technical difficulty.··That
12· · · ··document is frozen.
13· · · · · · · · ··MS. HUYSER:··Oh, no.
14· · · · · · · · ··MR. RUSSELL:··Can we take 10 minutes?··I
15· · · ··have this document and one other document, and then
16· · · ··I think I'll be done with this -- with
17· · · ··Ms. Patterson on cross.
18· · · · · · · · ··JUDGE GOLDSTEIN:··It's 3:10 now.··Let's
19· · · ··break till 3:25, okay?
20· · · · · · · · ··MR. RUSSELL:··Okay.··Thanks, Judge.
21· · · · · · · · ··JUDGE GOLDSTEIN:··The time is 3:10.
22· · · ··Thank you.
23· · · · · · · · ··(Break taken at 3:10 PM)
24· · · · · · · · ··(Break concluded at 3:26 PM)
25· · · · · · · · ··JUDGE GOLDSTEIN:··We're back on the

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·1· · · ··record in the matter of Viridis Laboratories, LLC,
·2· · · ··and Viridis North versus the Cannabis Regulatory
·3· · · ··Agency, consolidated Docket Numbers 21-029794,
·4· · · ··et al.··The time is 3:26 PM.
·5· · · · · · · · ··And, Counsel, you may continue.
·6· ·Q· ··(MR. RUSSELL) Ms. Patterson, I'm showing you what's
·7· · · ··been previously marked as Exhibit 7E.··Can you tell
·8· · · ··me if you recognize this document?
·9· ·A· ··Yes, sir, I do.
10· ·Q· ··Okay.··And what is the document?
11· ·A· ··So this document is essentially a subset of samples
12· · · ··that received testing by Viridis, I believe were
13· · · ··passed, and then these samples were audited to
14· · · ··other safety compliance facilities that are --
15· · · ··well, or were at that time using the same
16· · · ··methodology that Viridis was using and the results
17· · · ··of those retests.
18· ·Q· ··And how were the laboratories that conducted the
19· · · ··retests chosen?
20· ·A· ··They were chosen because they were the laboratories
21· · · ··that were using the same platform that Viridis was
22· · · ··using to conduct these tests.
23· ·Q· ··Were there other laboratories that were using the
24· · · ··same platform?
25· ·A· ··Not that I recall, no.

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·1· ·Q· ··How were these laboratories told to report these
·2· · · ··results?
·3· ·A· ··In what capacity?··Could you please clarify?
·4· ·Q· ··Well, were you sent an email, or was there a report
·5· · · ··in the Metrc?··How did they -- how did they report
·6· · · ··these?
·7· ·A· ··I do not recall exactly.··They may have sent an
·8· · · ··email with a certificate of analysis or they may
·9· · · ··have reported them in Metrc.
10· ·Q· ··Okay.··And then if you look at the far column, the
11· · · ··audit results, were there two tests for each
12· · · ··sample?
13· ·A· ··Yes, sir.
14· ·Q· ··So each -- each lab that did a retest did two
15· · · ··tests?
16· ·A· ··Yes, sir.
17· ·Q· ··Okay.··So just to confirm, for both of the last two
18· · · ··columns there's two tests?··So one states "Audit
19· · · ··results of Viridis retest sample" and one says
20· · · ··"Audit results of source package."
21· ·A· ··I believe that is the case, yes.
22· ·Q· ··Okay.··So when you say you believe that is the
23· · · ··case, so you believe that there were two retests
24· · · ··which would have been of the actual sample that
25· · · ··Viridis tested?

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·1· ·A· ··I -- based on what is here, it appears that these
·2· · · ··are retest samples that were collected by Viridis
·3· · · ··and then subsequently retested by these other
·4· · · ··laboratories.··So they would have done one test of
·5· · · ··one and one test of the other which would be two
·6· · · ··retests.
·7· · · · · · · · ··I apologize if I'm missing the question.
·8· ·Q· ··No, I think you're -- I just want to make sure I'm
·9· · · ··understanding the answer.
10· · · · · · · · ··So you're saying that they would have
11· · · ··just did one test of the Viridis -- the sample that
12· · · ··they received from Viridis and one test from the
13· · · ··source?··Is that what you're saying?
14· ·A· ··These appear to be retest samples, so it appears to
15· · · ··have been a retest of the retest that was collected
16· · · ··by Viridis just based on the sequential number of
17· · · ··the Metrc tags.
18· ·Q· ··Two samples for each, fail, fail?
19· ·A· ··Well, in -- in the far right column, yes, that is
20· · · ··what that says.
21· ·Q· ··Is that what -- do you know if that's what
22· · · ··happened, though?
23· ·A· ··Based on this information here, it does appear that
24· · · ··that is what happened, yes.
25· ·Q· ··Okay.··Do you know that for a fact that that was

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·1· · · ··what happened?
·2· ·A· ··I would have to look at the data to confirm that
·3· · · ··information.
·4· · · · · · · · ··MR. RUSSELL:··I'd like to move to have
·5· · · ··this admitted as Exhibit 21.
·6· · · · · · · · ··MS. HUYSER:··Just permission to voir dire
·7· · · ··quickly.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Sure.··Go ahead.
10· · · · · · · · · ··VOIR DIRE EXAMINATION
11· ·BY MS. HUYSER:
12· ·Q· ··Ms. Patterson, did you consolidate this data or
13· · · ··generate this chart?
14· ·A· ··This chart would have been collected and
15· · · ··consolidated by the LSS team, and all of the data
16· · · ··would have been submitted either by way of Metrc or
17· · · ··certificates of analysis by the laboratories.
18· ·Q· ··And are you familiar with this chart?··Have you
19· · · ··seen it before and familiar with its contents?
20· ·A· ··I have seen this chart before, yes.··The exact
21· · · ··details I would have to refer to the data given
22· · · ··that it's been some period of time, but it is
23· · · ··familiar to me, yes.
24· ·Q· ··Okay.··And do you believe that it's an adequate
25· · · ··representation of what the LSS would have put

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·1· · · ··together?
·2· ·A· ··Yes.
·3· · · · · · · · ··MS. HUYSER:··Okay.··I have no objection.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··This has been
·5· · · ··marked as Viridis 20; correct?
·6· · · · · · · · ··MR. RUSSELL:··21, Your Honor.
·7· · · · · · · · ··You can take it down.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··All right.
·9· · · ··Viridis Exhibit 21 is admitted.
11· · · · · · · · ··MR. RUSSELL:··Your Honor, I have no
12· · · ··further questions for this witness.
13· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Redirect?
14· · · · · · · · ··MS. HUYSER:··Thank you, Your Honor.··Give
15· · · ··me one second here to get back to where we are.
16· · · · · · · · · · ·REDIRECT EXAMINATION
18· ·Q· ··All right.··I am going to circle back and start
19· · · ··back, Ms. Patterson, with a couple things that we
20· · · ··spoke about this morning as far as testimony, or at
21· · · ··least earlier today.
22· · · · · · · · ··You -- there were some questions about
23· · · ··reaching out to multiple different sources or
24· · · ··different individuals in seeking confirmation or to
25· · · ··seek their opinion.

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·1· · · · · · · · ··Why did you do that?
·2· ·A· ··The reason that I did that was because I was
·3· · · ··directed to do so by my directors, operations
·4· · · ··directors, managers and otherwise, but really just
·5· · · ··to receive written confirmation that my analysis
·6· · · ··and my team's analysis was correct.··But also to,
·7· · · ··quite honestly, double-check ourselves and to
·8· · · ··confirm and give the licensee a bit of the benefit
·9· · · ··of the doubt and make sure that we weren't
10· · · ··interpreting something incorrectly.
11· ·Q· ··And after your conversations with them, did you
12· · · ··receive what you felt to be confirmation, or did
13· · · ··you receive information that contradicted what your
14· · · ··opinion was?
15· ·A· ··No, I received confirmation in all of these
16· · · ··instances.
17· ·Q· ··And in particular this confirmation or this
18· · · ··discussion arose out of standard operating
19· · · ··procedure regarding keeping temperature and time
20· · · ··logs; correct?
22· ·Q· ··And in the -- the complaints it is alleged that
23· · · ··they -- because logs or documents were not kept
24· · · ··that that is a violation of a standard operating
25· · · ··procedure; correct?

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·1· ·A· ··That is correct.
·2· ·Q· ··And how is it a violation?
·3· ·A· ··Well, so it's actually kind of a two-part
·4· · · ··violation.··So when a manufacturer validates a
·5· · · ··method, they validate it under very specific
·6· · · ··parameters, as we've discussed before.··You know,
·7· · · ··those temperature requirements are quite tight.··It
·8· · · ··may be plus or minus one or two degrees.··Some of
·9· · · ··them actually require the exact temperature
10· · · ··specification.
11· · · · · · · · ··And the same thing goes for time.··So
12· · · ··there may be an allotment of time range plus or
13· · · ··minus two hours or so.··It depends, based on the
14· · · ··tests, but they're all very limited ranges.
15· · · · · · · · ··And so it's important to note that the
16· · · ··manufacturers themselves actually state that if the
17· · · ··test is performed outside either those time or
18· · · ··temperature parameters, that they do not stand by
19· · · ··the validity of those results and they're not
20· · · ··legally defensible.··And that additionally a
21· · · ··validation would need to be done to confirm that
22· · · ··any tests that fell outside of those parameters
23· · · ··were accurate or precise in any way.
24· · · · · · · · ··But additionally, another portion of the
25· · · ··laboratories' SOPs that they were not following was

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·1· · · ··their own laboratory quality management procedure
·2· · · ··related to facilities and environmental conditions.
·3· · · ··And that specifically stated that the laboratory
·4· · · ··will monitor, control, and record environmental
·5· · · ··conditions as required by the relevant
·6· · · ··specifications, methods, or procedures, or where
·7· · · ··those deviations may impact the quality of the
·8· · · ··results.
·9· ·Q· ··So if the SOP does not say -- is not approved by
10· · · ··you with the actual language that says "You have to
11· · · ··keep time and temperature logs," how do you read
12· · · ··that in there?
13· ·A· ··So it doesn't have to state that there's an actual
14· · · ··time and temperature log, but because the
15· · · ··manufacturer requires that those time and
16· · · ··temperature parameters are adhered to, the commonly
17· · · ··accepted way to prove that, essentially, is by
18· · · ··keeping logs.··Keeping a data tracker that tracks
19· · · ··temperature throughout the course of time to ensure
20· · · ··that there are no deviations and to keep a log that
21· · · ··identifies time to ensure that the laboratory is
22· · · ··and can verify that they're incubating those tests
23· · · ··for the appropriate amount of time.··And so the
24· · · ··absence of that, of course, is concerning.
25· · · · · · · · ··But, additionally, they have their own,

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·1· · · ··as I stated, quality manual that says that they
·2· · · ··will keep those records.··And so that in and of
·3· · · ··itself also indicates the need for a log.
·4· ·Q· ··And is it required as part of the standard
·5· · · ··operating procedure to comply with manufacturer
·6· · · ··requirements?
·7· ·A· ··Yes, it is.
·8· ·Q· ··And is that written into the SOP?
·9· ·A· ··That's not specifically written into the SOP, but
10· · · ··that is the method that was validated.··It was the
11· · · ··method that was approved.··And when a laboratory
12· · · ··submits a method like that directly from the vendor
13· · · ··with their own verification, they're doing so by
14· · · ··saying, you know, "We follow this method as the
15· · · ··manufacturer validated it."
16· ·Q· ··Thank you.··All right.··So I'm going to circle back
17· · · ··to -- I apologize -- last week most likely.··So if
18· · · ··there's any -- if I ask a question that's not
19· · · ··jogging your memory or something, please let me
20· · · ··know.
21· ·A· ··(Moves head up and down)
22· ·Q· ··So when you -- there's been some discussion both
23· · · ··today and previously about the science division and
24· · · ··collectively referred to as LSSs; correct?

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·1· ·Q· ··Now, how does an LSS analyze data?
·2· ·A· ··So an LSS analyzes data that is given to us, as I
·3· · · ··said before, that's been pulled from a data analyst
·4· · · ··typically with the operations support section.
·5· · · ··That data is pulled directly from Metrc, given to
·6· · · ··us in its raw data form, lots of data in there
·7· · · ··typically, and that requires a lot of sorting and
·8· · · ··parsing things out to actually look at the data or
·9· · · ··try and identify what it is that we're looking at.
10· ·Q· ··And what types of checks or are there checks and
11· · · ··balances in place to kind of ensure that this data
12· · · ··is analyzed accurately?
13· ·A· ··Yes.··So within the Agency, of course, we, like I
14· · · ··said, get the data from the data analyst.··That
15· · · ··comes directly to us from Metrc.··Metrc data itself
16· · · ··is not editable, so then this will come over to us.
17· · · ··And then the team will look at it together, you
18· · · ··know.··It may go up and down the chain.··The data
19· · · ··may come to me for review, and then I will send it
20· · · ··to the LSSs to peer review and double-check.··They
21· · · ··may look at the data and then peer review with one
22· · · ··another before they provide that to me.··But
23· · · ··ultimately the data goes up and down the chain
24· · · ··through various forms of peer review before any of
25· · · ··that is reported out to the division director and

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·1· · · ··then the operations director as is warranted.
·2· ·Q· ··Now, I've never worked in a laboratory setting or
·3· · · ··anything along those lines.··Is peer review a
·4· · · ··common method that's done in a laboratory setting?
·5· ·A· ··Yeah.··There -- I mean, it's important to have peer
·6· · · ··review.··And even in our laboratories we typically
·7· · · ··see that they have a laboratory manager as well as,
·8· · · ··like, a quality systems manager just to provide a
·9· · · ··backup or a double check that the data is what it's
10· · · ··supposed to be.··That they're following the SOPs.
11· · · ··And the same thing applies within the Agency.
12· ·Q· ··And at a point early on Allyson Chirio, Dr. Chirio,
13· · · ··was on your LSS team; correct?
15· ·Q· ··And did the same level of oversight or peer review
16· · · ··apply to anything that Allyson may have analyzed?
18· ·Q· ··Did it apply to anything that Dr. Rosenzweig would
19· · · ··have analyzed?
21· ·Q· ··Or Dr. Fields?
23· ·Q· ··And what about yourself?
25· ·Q· ··Even though you're the manager, you still subject

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·1· · · ··yourself to review from your team?
·2· ·A· ··Absolutely.··I'm a scientist at heart, and my team,
·3· · · ··as has been noted, I have a team of doctors, so I
·4· · · ··have them look at the work that I do.··We peer
·5· · · ··review one another in the spirit of scientific
·6· · · ··collaboration and making sure that we're all
·7· · · ··reviewing one another.
·8· ·Q· ··And one of the things you mentioned was, again, you
·9· · · ··said Metrc cannot be changed or edited.··I know
10· · · ··we've talked about Metrc, and it's been thrown out
11· · · ··there, but remind me again, what is Metrc?
12· ·A· ··Metrc is the statewide monitoring system.
13· · · ··Effectively a supply chain management system where
14· · · ··data is input.··Once it gets in there, though, it
15· · · ··lives there forever.··There's no way to edit it or
16· · · ··remove it.··It's there in perpetuity.
17· ·Q· ··Does the CRA have control over Metrc, or is this a
18· · · ··third-party oversight?··How does this work?
19· ·A· ··Well, this is a third-party oversight.··I believe
20· · · ··there's a government contract or something of that
21· · · ··nature with them that contracts the service out to
22· · · ··them.··They house the data itself.··And, granted, I
23· · · ··mean, we have control over the parameters that are
24· · · ··set within there.··For instance, our testing
25· · · ··limits, we set those.··Metrc assists us in -- and

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·1· · · ··forgive me -- creating the programming or whatever
·2· · · ··it is those IT people do to make sure that it
·3· · · ··operates within the confines of our rules.
·4· ·Q· ··Can the CRA delete data out of Metrc?
·5· ·A· ··No.
·6· ·Q· ··Can the CRA edit a number that's in Metrc?
·7· ·A· ··No.
·8· ·Q· ··Can the CRA override something as far as even just
·9· · · ··an authorization or anything like that in the Metrc
10· · · ··program?
11· ·A· ··The only thing that we can do is provide overrides
12· · · ··of, for instance, testing statuses, or if packages
13· · · ··need to be transferred somewhere or another, as the
14· · · ··regulatory body we can provide those overrides.
15· · · ··But as it relates to data, data transformation or
16· · · ··anything like that, no, we do not have that
17· · · ··ability.
18· ·Q· ··When you say "override a testing status," what do
19· · · ··you mean?
20· ·A· ··So Metrc is a data input system.··It's not the
21· · · ··smartest system in the world.··Data comes in.
22· · · ··That's pretty much it.··And so there are instances
23· · · ··where testing will occur, and essentially what will
24· · · ··happen is packages get locked up is what we call
25· · · ··it.

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·1· · · · · · · · ··So, for example, if there is a full
·2· · · ··compliance test done, and then a licensee chooses
·3· · · ··to do research and development testing after that,
·4· · · ··it will bump the status into this no man's land
·5· · · ··where essentially it says it's testing in progress.
·6· · · · · · · · ··And so we go in there, in these instances
·7· · · ··typically a licensee, whether it's a laboratory or
·8· · · ··a cultivator, any other licensee, will request a
·9· · · ··status override.··We go into the system, look at
10· · · ··all the data and all the history, and we say, okay,
11· · · ··there's no concerns about the fact that they did
12· · · ··R&D testing after full compliance testing.··Please
13· · · ··update the status to its appropriate full
14· · · ··compliance test results.
15· · · · · · · · ··So it's really just to help assist the
16· · · ··licensees move their packages through the system.
17· ·Q· ··But once a licensee uploads a particular number or
18· · · ··a certain percentage or anything like that, can a
19· · · ··CRA go in and change that?
20· ·A· ··No.
21· ·Q· ··Can a CRA change it from a pass to a fail?
22· ·A· ··We could if we had the appropriate reason to.··But
23· · · ··that's completely based on what the testing
24· · · ··requirements are.··And those parameters are set up
25· · · ··in the system themselves.

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·1· ·Q· ··And those numbers, would they still exist even if
·2· · · ··you changed it from a pass to a fail?
·3· ·A· ··Yes.
·4· ·Q· ··So someone could always go back and look at those
·5· · · ··numbers?
·7· ·Q· ··What if there's a typo?
·8· ·A· ··If there was a typo on behalf of the laboratory,
·9· · · ··there are instances where that has happened, a
10· · · ··laboratory will contact us, let us know that
11· · · ··there's a typo, and ask us permission to upload
12· · · ··additional results.··So we'll allow them to correct
13· · · ··the upload by adding those additional results, but
14· · · ··the incorrect results don't disappear.··They're
15· · · ··still there.
16· ·Q· ··So I want to go back a little bit to the -- when
17· · · ··A2LA -- there was some conversation about them
18· · · ··performing an audit.··Can you tell me a little bit
19· · · ··about what an A2LA audit is?
20· ·A· ··So A2LA is a third-party accrediting body.··They
21· · · ··accredit to various standards -- excuse me -- but
22· · · ··in this case it would be the ISO 17025 standard.
23· · · ··So when they're auditing for that, essentially they
24· · · ··go into a laboratory space and assess the
25· · · ··laboratory to determine whether or not they have an

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·1· · · ··acceptable quality management system in place.··And
·2· · · ··essentially they're just saying that the system is
·3· · · ··in place and the laboratory has the ability to
·4· · · ··provide testing and calibration results to paying
·5· · · ··clients.
·6· ·Q· ··And do they check the same thing every single time
·7· · · ··they go there for -- like, do they have a checklist
·8· · · ··that they check the same contents every single
·9· · · ··time?
10· ·A· ··They do have a checklist.··It's largely related to
11· · · ··the quality management system.··So there's an
12· · · ··exhausting period of quality management manual
13· · · ··review where they say, you know, "Do you have the
14· · · ··appropriate things in place for your laboratory
15· · · ··that meet the requirements of ISO 17025?"··And that
16· · · ··relates to things like calibration of equipment,
17· · · ··making sure that you're tracking standards
18· · · ··appropriately, essentially making sure that the
19· · · ··infrastructure of the laboratory at its very base
20· · · ··level has the ability to operate correctly.
21· ·Q· ··And to your knowledge was Viridis ever found to be
22· · · ··out of compliance with A2LA?
23· ·A· ··Yes.
24· ·Q· ··Can you tell me about that, please?
25· ·A· ··It's not necessarily uncommon for a laboratory to

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·1· · · ··be found in noncompliance with the ISO 17025
·2· · · ··requirements.
·3· · · · · · · · ··Specifically, one thing that comes to
·4· · · ··mind as it relates to microbials is A2LA did note
·5· · · ··that the laboratory did not have the appropriate
·6· · · ··environmental controls in place to monitor their
·7· · · ··microbial tests.··There were some audits that were
·8· · · ··conducted later on, and I'd have to look at the
·9· · · ··date, but -- that were conducted more recently that
10· · · ··stated that they were not keeping track of scales.
11· · · ··I believe there were not the appropriate
12· · · ··calibrations being used.··Scales were out of
13· · · ··specification and were still being used in the
14· · · ··laboratory space.··Just various things that were
15· · · ··wrong in the quality management system that should
16· · · ··have been in check.
17· ·Q· ··And was there a time in September of 2021 where
18· · · ··they had some issues?
19· ·A· ··Yes.··That's when they noted -- and that was
20· · · ··specifically at the Viridis North location -- that
21· · · ··they were not keeping track or they were unable to
22· · · ··keep track of temperature, specifically as it
23· · · ··relates to their microbial tests.
24· ·Q· ··And was that before you went back in October of
25· · · ··2021, obviously?

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·1· ·A· ··Yes, it was.
·2· ·Q· ··And did you find the same type of defects in
·3· · · ··October that were present when A2LA was there in
·4· · · ··September?
·5· ·A· ··Yes, we did.
·6· ·Q· ··And does that have any significance to you?
·7· ·A· ··Yes, because, you know, as a former manager and
·8· · · ··quality manager of a laboratory, when you find out
·9· · · ··that your laboratory is operating in a way that's
10· · · ··out of alignment with the quality management
11· · · ··requirements, that's something that you want to fix
12· · · ··immediately.··You know, obviously acknowledging
13· · · ··that you may have to order things, you may have to
14· · · ··get various procedures and whatnot in place.··But
15· · · ··that should be a high priority, because ultimately
16· · · ··that impacts the test results that you're providing
17· · · ··to clients, consumers, etc., depending on what it
18· · · ··is that the laboratory reports on.
19· ·Q· ··And if there is ever a conflict between the
20· · · ··accrediting body and the regulatory body, how does
21· · · ··that get resolved?
22· ·A· ··So there are occasionally conflicts between them.
23· · · ··Ultimately a laboratory's activities are required
24· · · ··to be carried out in a way that meets the
25· · · ··requirements of not only ISO 17025 specifications

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·1· · · ··but also in a way that satisfies the laboratory's
·2· · · ··customers as well as regulatory authorities or any
·3· · · ··organizations providing recognition.
·4· · · · · · · · ··So that's all to say that ISO
·5· · · ··accreditation does not trump regulations that a
·6· · · ··laboratory is subject to.··A laboratory will be
·7· · · ··subject to regulations by whomever its regulatory
·8· · · ··body is as well as ISO, and ISO is responsible for
·9· · · ··those quality management systems and oversight.
10· ·Q· ··And throughout the last few days you've had some --
11· · · ··you've talked about the different types of times
12· · · ··that a CRA will observe the practices going on in a
13· · · ··laboratory.··So can you kind of walk me through
14· · · ··what the times -- or what are they -- what type of
15· · · ··process do you use to oversee a lab?··Like what
16· · · ··type of inspections, anything along those lines?
17· ·A· ··So there is a lot of ways that we may oversee their
18· · · ··processes and procedures.··First would be through
19· · · ··inspections.··Inspections are performed, as I said,
20· · · ··in association with a specific checklist, and those
21· · · ··checklists are based on -- essentially generated on
22· · · ··content that is a part of the current
23· · · ··administrative rules, whatever is active at that
24· · · ··point in time.
25· · · · · · · · ··And so in those inspections we go in, we

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·1· · · ··assess the laboratory's compliance with the rules
·2· · · ··as they're written.
·3· · · · · · · · ··Additionally we have investigations, of
·4· · · ··course.··Investigations occur if there is a
·5· · · ··situation that is not in compliance with the
·6· · · ··administrative rules or potentially not in
·7· · · ··compliance with the administrative rules, depending
·8· · · ··on the case.
·9· · · · · · · · ··There are Method Approval Reports and
10· · · ··Method Validation Summaries.··Those particularly
11· · · ··relate to methods that are submitted, SOPs,
12· · · ··verifications, validations.··So I'll break those
13· · · ··into two.
14· · · · · · · · ··So the Method Approval Reports serve as a
15· · · ··running log of the methods that have been submitted
16· · · ··in their complete form and essentially whether or
17· · · ··not there was a subsequent approval or denial.
18· · · ··They're dated.··Just to help the laboratory and the
19· · · ··Agency keep track of what is specifically happening
20· · · ··at that point in time.
21· · · · · · · · ··Additionally -- and these two always go
22· · · ··together.··So Method Approval Reports and then the
23· · · ··Method Validation Summaries always travel together.
24· · · ··So the Method Validation Summaries are far more
25· · · ··detailed than the approval reports.··So the

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·1· · · ··validation summaries accompany a specific SOP that
·2· · · ··was submitted to the Agency, and we return that
·3· · · ··with the Method Approval Report.··But that document
·4· · · ··further details our review of the validation.
·5· · · · · · · · ··So we, essentially, go through it and
·6· · · ··say, you know, "This is our reason for acceptance.
·7· · · ··This is our reason for denial."··You know, if there
·8· · · ··is a denial that's issued, we talk about what's
·9· · · ··missing, whether or not it meets the standard
10· · · ··method performance requirements, additional things
11· · · ··that we would require for submission if there's
12· · · ··some, you know, missing portion of the data or some
13· · · ··incomplete portion of the data that we'd like to
14· · · ··see more of.··There's very, very detailed
15· · · ··documents.
16· · · · · · · · ··We also do audits.··Audits may be done
17· · · ··really at any point in time.··They may be done in
18· · · ··concert with an inspection or just randomly.··They
19· · · ··may be done as followup from an interlaboratory
20· · · ··comparison if we see complaints or as part of an
21· · · ··investigation.··And those are really done just to
22· · · ··ensure that the lab is operating in compliance with
23· · · ··our regulatory standards but also making sure that
24· · · ··they're complying with their own standard operating
25· · · ··procedures.··And that's more of a technical review.

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·1· · · ··It really looks at how the laboratory is operating
·2· · · ··technically on the day-to-day in a particular
·3· · · ··method.
·4· · · · · · · · ··And then -- I'm trying to think what else
·5· · · ··there is.··I guess the last thing that we do -- and
·6· · · ··I wouldn't say that this is necessarily oversight
·7· · · ··of the laboratories themselves -- are the
·8· · · ··interlaboratory comparison events.··And those are
·9· · · ··really more to determine whether or not methods are
10· · · ··performing well or as they are specified.
11· ·Q· ··So you mentioned inspections.··Are those typically
12· · · ··done on a particular timeline twice a year?··Four
13· · · ··times a year?··When are inspections usually done?
14· ·A· ··Inspections are fairly regular.··They're
15· · · ··semi-annual.··They're done twice a year.··To this
16· · · ··point in time we carve out some time at the
17· · · ··beginningish of the year and the endish of the year
18· · · ··to do those inspections for all the laboratories as
19· · · ··a group.··I mean, not a group collectively
20· · · ··together, but they're all done within that period
21· · · ··of time.
22· ·Q· ··Okay.··And can you get a method approved during a
23· · · ··semi-annual inspection?
24· ·A· ··No.
25· ·Q· ··Okay.··And you talked about an investigation.··So

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·1· · · ··an investigation is another form of oversight.
·2· · · · · · · · ··Would you ever appear at a laboratory
·3· · · ··during an investigation?
·5· ·Q· ··And what is your purpose for going there?
·6· ·A· ··Typically the reason that we would go to a
·7· · · ··laboratory during an investigation would be to
·8· · · ··confirm something that we needed to see in person,
·9· · · ··something that was going on on site.··Particularly
10· · · ··as it relates to laboratories, it would be in
11· · · ··association with a method that they were using,
12· · · ··trying to determine if they were in compliance with
13· · · ··their quality manual.··There's definitely a lot --
14· · · ··a lot more things on site at the laboratory that we
15· · · ··would or could need to see in person to actually
16· · · ··visually confirm.
17· ·Q· ··Are there times during an investigation that you
18· · · ··may go on site and determine, oh, look, everything
19· · · ··is good?
21· ·Q· ··And what would you do under those circumstances?
22· ·A· ··If that were the case, if we had a complaint, we
23· · · ··went on site to a laboratory, we determined that
24· · · ··there was no noncompliances with the administrative
25· · · ··rules, we would note that in our notes, our

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·1· · · ··reports.··We would go back, write a very brief
·2· · · ··report likely as there's no evidence or data, say
·3· · · ··that there's nothing to substantiate the claim in
·4· · · ··the complaint and close it out.
·5· ·Q· ··Can you get a method approved during an
·6· · · ··investigation?
·7· ·A· ··No.
·8· ·Q· ··And you talked about audits.··And so an audit, is
·9· · · ··that -- you said that can be done at any point in
10· · · ··time?
11· ·A· ··Yes, audits may be done at any point in time.··And
12· · · ··they may be associated with, you know, an
13· · · ··investigation or something that has our attention
14· · · ··flagged to a laboratory, or they may be done just
15· · · ··to assess methods generally.
16· · · · · · · · ··Potentially if we have a concern with a
17· · · ··method, we may perform an audit on a number of
18· · · ··laboratories just to see how the method itself is
19· · · ··operating.
20· ·Q· ··And when you do audits, do you just look at one
21· · · ··type of method or is it an audit of the entire
22· · · ··laboratory process?
23· ·A· ··Typically we'll only be looking at one type of
24· · · ··method unless there is some reason for us to look
25· · · ··at more than one.··You know, if we had a complaint

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·1· · · ··that warranted us looking at more than one, yes, we
·2· · · ··would look at it.··If we had concerns about the
·3· · · ··laboratory not following procedures, potentially,
·4· · · ··yes, we would look at them, but typically they're
·5· · · ··limited in scope in some capacity.
·6· ·Q· ··And can you get a method approved during an audit?
·7· ·A· ··No.
·8· ·Q· ··And interlaboratory comparisons.
·9· ·A· ··Uh-huh.
10· ·Q· ··That's another form that you mentioned of
11· · · ··oversight.··How often are those done?
12· ·A· ··Those are done quarterly.··Typically, though, I
13· · · ··will admit that during COVID that schedule was very
14· · · ··different.
15· ·Q· ··And when you do an interlaboratory comparison,
16· · · ··again, is it over entire lab practices or is it
17· · · ··focused on just one type of SOP or one type of test
18· · · ··during those comparisons?
19· ·A· ··So neither of those necessarily.
20· ·Q· ··Okay.
21· ·A· ··It really -- so the interlaboratory comparisons, I
22· · · ··think I've said this before, are -- it's a
23· · · ··collection of composite samples that are all put
24· · · ··together, and really it's an overview of typically
25· · · ··how one method is performing or a group of methods

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·1· · · ··are performing potentially.··And, like I said too,
·2· · · ··it's more of an assessment that the method or the
·3· · · ··method vendor, that those things are performing the
·4· · · ··way that they say that they're supposed to, but
·5· · · ··also looking at whether or not they're performing
·6· · · ··similarly.
·7· · · · · · · · ··So, for example, you know, we have three
·8· · · ··vendors let's say that our laboratories use for
·9· · · ··microbial methods.··We would group those and say,
10· · · ··okay, you know, this group has one, this group has
11· · · ··two, this group has three.··Are they performing
12· · · ··similarly to one another?··And then how are those
13· · · ··methods performing against each other as well.
14· ·Q· ··And can you get a method approved during an
15· · · ··interlaboratory comparison?
16· ·A· ··No.
17· ·Q· ··So correct me if I'm wrong.··The only pathway to
18· · · ··get a method approved is to have a Method
19· · · ··Validation Summary -- the entire method validation
20· · · ··approval done; correct?
22· ·Q· ··Okay.··And you've testified at length about that
23· · · ··process, so I'm not going to walk you through it,
24· · · ··but there -- when you get to the end there's the
25· · · ··Method Approval Report which we -- which the ALJ

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·1· · · ··asked you a significant amount of questions on.··Do
·2· · · ··you recall discussing that?
·3· ·A· ··Yes, I do.
·4· ·Q· ··Okay.··And since the January -- or excuse me --
·5· · · ··December of 2020 email exchange with Viridis
·6· · · ··collectively, have there been other methods that
·7· · · ··were approved or modifications to methods that were
·8· · · ··approved by Viridis?··Or for Viridis?
·9· ·A· ··I just wanted to verify.··Thank you.
10· · · · · · · · ··Yes, there have been other methods that
11· · · ··have been approved for Viridis.··I can't recount
12· · · ··exactly how many, but I know that there have been a
13· · · ··number.
14· ·Q· ··And when they submitted those methods for approval,
15· · · ··did they submit the correct paperwork?
16· ·A· ··Yes, they did.
17· ·Q· ··And did they follow the procedure without any
18· · · ··issue?
19· ·A· ··Yes, they did.
20· ·Q· ··Did they have any trouble reaching out and asking
21· · · ··if they had any questions?
22· ·A· ··No, they did not.
23· ·Q· ··And did you either accept or deny those all or
24· · · ··approve or deny those all in writing?
25· ·A· ··Yes, we did.

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·1· ·Q· ··And their -- all of those approvals are kept on
·2· · · ··these Method Approval Report living document that
·3· · · ··you walked through with the ALJ?
·4· ·A· ··Yes.··So the record is kept on there, and then
·5· · · ··they're also sent back with a Method Validation
·6· · · ··Summary detailing the approval or denial, depending
·7· · · ··on the case.
·8· ·Q· ··And when we're talking about the -- about potency,
·9· · · ··if you're looking at the Method Approval Report and
10· · · ··it's talking about aspergillus or microbials, would
11· · · ··you expect to see a change in the section
12· · · ··pertaining to potency?
13· ·A· ··No.
14· ·Q· ··Why not?
15· ·A· ··Because the Method Approval Report or the summary
16· · · ··at that point in time wasn't referring to anything
17· · · ··having to do with potency but rather whatever was
18· · · ··submitted at that time.··So in this example it
19· · · ··would have been aspergillus or microbials.
20· ·Q· ··And, again, why -- when we're talking about June of
21· · · ··2021, and that being a written denial being
22· · · ··provided to Viridis, why did that not happen in
23· · · ··November or December or any of those months in
24· · · ··between?
25· ·A· ··Because during that period of time we were still

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·1· · · ··trying to, honestly, figure out what was going on
·2· · · ··at the laboratory.··To be frank with you, around
·3· · · ··November, you know, we started asking questions
·4· · · ··trying to figure out why there was high potency
·5· · · ··trying to get more information and clarification on
·6· · · ··the SOP that was submitted to us.··The data, as
·7· · · ··I -- I think I stated too, the data didn't
·8· · · ··necessarily align that Michele had submitted with
·9· · · ··the research summary or the method that was
10· · · ··submitted.··There were just inconsistencies there.
11· · · · · · · · ··And it was during the height of COVID
12· · · ··again, an additional wrench into things.··But we
13· · · ··were really trying to figure out and, honestly,
14· · · ··trying to assist the laboratory to bridge that gap
15· · · ··in understanding and say, you know, what's really
16· · · ··going on here?··How -- how can we help you?··How
17· · · ··can you help us get more information about this
18· · · ··method?··And it was really challenging because it
19· · · ··felt like the information was kind of all over the
20· · · ··place, and it was hard to get the information that
21· · · ··we needed and the answers to the questions that we
22· · · ··were asking.
23· ·Q· ··In your relationship with Viridis, I know there's
24· · · ··been some comment that -- commentary or testimony
25· · · ··or statements about it being adversarial.··When

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·1· · · ··you -- when you used that phrase earlier, what did
·2· · · ··you mean?
·3· ·A· ··So it's actually -- that's a great point.··I'd like
·4· · · ··to clarify, because I felt like I personally had a
·5· · · ··good relationship with Viridis for a very long
·6· · · ··time.··I know that they came to me to discuss
·7· · · ··methods, to discuss various things.··We always had
·8· · · ··a very good, jovial relationship in person.··But I
·9· · · ··felt like when we started asking questions and we
10· · · ··started particularly asking questions about this
11· · · ··potency method they started to get adversarial with
12· · · ··us, and it felt like, you know, every question was
13· · · ··met with resistance despite the fact that I really
14· · · ··just wanted to help them and wanted to bridge our
15· · · ··gap in understanding and figure out really what was
16· · · ··going on.
17· ·Q· ··And there was a reference to being an expert
18· · · ··reviewer for AOAC.··What is that?
19· ·A· ··So an expert reviewer for AOAC, an individual can
20· · · ··be brought in as an expert reviewer for, you know,
21· · · ··one method or a number of methods.··And so what
22· · · ··that individual will do and what I did was review
23· · · ··methods that were submitted as part of the
24· · · ··Emergency Response Validation Program.··And so you
25· · · ··review the method, you review the associated data.

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·1· · · ··You're part of the panel of reviewers.··And you'll,
·2· · · ··you know, review the method and provide feedback to
·3· · · ··the vendor or whomever is submitting that data or
·4· · · ··information.
·5· ·Q· ··And how is that connected to the R-Squared Program?
·6· ·A· ··In my experience it was not connected to the
·7· · · ··R-Squared Program.··I believe it's just in title
·8· · · ··only as I think they grab from the same pool of
·9· · · ··individuals who do emergency response validations.
10· · · ··And you may also be asked to review R-Square
11· · · ··methods, though I have never reviewed an R-Square
12· · · ··method.
13· ·Q· ··And at this point in time have you ever approved a
14· · · ··potency method for Viridis after January -- excuse
15· · · ··me -- after May of 2020?
16· ·A· ··No.
17· ·Q· ··And that May of 2020 is connected to the January of
18· · · ··2020 method; correct?
19· ·A· ··That is correct.··The May method clarified the term
20· · · ··"homogenization" or "homogenize."
21· ·Q· ··Were there any other changes other than the
22· · · ··clarification of the term?
23· ·A· ··No.
24· ·Q· ··Is the process that was followed the same outline
25· · · ··in both SOPs?

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·1· ·A· ··Yes.
·2· ·Q· ··And if you were to walk into Viridis Laboratories
·3· · · ··today, what method would you expect them, if they
·4· · · ··were to be in accordance with the rules, to be
·5· · · ··following?
·6· ·A· ··I would expect them to be following the January of
·7· · · ··2020 method as clarified in May of 2020.
·8· ·Q· ··Thank you.
·9· · · · · · · · ··MS. HUYSER:··I have nothing further at
10· · · ··this time.
11· · · · · · · · ··JUDGE GOLDSTEIN:··Any cross?
12· · · · · · · · · · ·RECROSS-EXAMINATION
13· ·BY MR. RUSSELL:
14· ·Q· ··Ms. Patterson, you testified I think again in
15· · · ··relation to what you've deemed are requirements in
16· · · ··the SOPs related to incubation in and out times.
17· · · ··Do you recall that?
18· ·A· ··Yes, sir.
19· ·Q· ··Okay.··And I believe last week you referred to that
20· · · ··as being something that was inherent.··Today you
21· · · ··talked about sending emails out for confirmation to
22· · · ··other experts, and you testified that you didn't
23· · · ··need to do that but you were directed to.
24· · · · · · · · ··Who directed you to send those emails
25· · · ··out?

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·1· ·A· ··It would have been one of my managers.··Either the
·2· · · ··Enforcement Division director or the Operations
·3· · · ··director.
·4· ·Q· ··So would that be Julie Kluytman or
·5· · · ··Desmond Mitchell?
·6· ·A· ··Yes, sir.
·7· ·Q· ··And I -- just to be clear on this point, the
·8· · · ··requirement, as you call it, to keep these -- these
·9· · · ··log times, it's not in the SOP; correct?
10· ·A· ··It is not -- not stated explicitly in the SOP for
11· · · ··microbials, no.
12· ·Q· ··And, if you recall, the Court of Claims judges,
13· · · ··actually two judges, Judge Murray and then
14· · · ··Judge Cameron, both determined that --
15· · · · · · · · ··MS. HUYSER:··Your Honor, I'm going to
16· · · ··object at this point in time.··He is paraphrasing a
17· · · ··judge's opinion or a judicial opinion as though
18· · · ··it's case law at this point in time.··I don't think
19· · · ··that that's appropriate, and it's not relevant to
20· · · ··the procedures that are here.
21· · · · · · · · ··MR. RUSSELL:··It's absolutely relevant,
22· · · ··Your Honor.··This -- this has already been
23· · · ··determined by a judge that it's not required by an
24· · · ··SOP, a rule, or a statute, and, therefore, the
25· · · ··recall that it was based on was overturned on

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·1· · · ··those -- on those insures.··So from a legal
·2· · · ··standpoint it absolutely has been determined.
·3· · · · · · · · ··If this witness has any relevant facts
·4· · · ··that it actually is in an SOP or a statute or a
·5· · · ··rule, I'd like to hear it.
·6· · · · · · · · ··MS. HUYSER:··And she did testify to that,
·7· · · ··Your Honor, about what it's connected to and where
·8· · · ··it is, so she did answer that question.··And
·9· · · ··furthermore the recall is not part of this matter.
10· · · ··So whether there was a determination made on a
11· · · ··recall I don't believe binds this court as to
12· · · ··reviewing and listening to testimony.
13· · · · · · · · ··MR. RUSSELL:··Yeah, I agree with
14· · · ··Ms. Huyser the Court of Claims already determined
15· · · ··that there was a substantive due process violation
16· · · ··that related to the recall, but the actual
17· · · ··determination as to whether there's a violation of
18· · · ··the SOP to testing of microbials is one of the
19· · · ··three prongs of the superseding complaint at issue
20· · · ··brought by the CRA.··I get they want to not have
21· · · ··the ruling by the Court of Claims brought into this
22· · · ··court, but we have collateral estoppel.··They're
23· · · ··estopped from making that argument they
24· · · ··continuously make by the fact that a judge has
25· · · ··already ruled on this specific issue.

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·1· · · · · · · · ··MS. HUYSER:··Just to clarify, I did not
·2· · · ··concede anything about it or even mention a
·3· · · ··substantive due process claim, just to make that
·4· · · ··clear.
·5· · · · · · · · ··MR. RUSSELL:··Well, to be clear, the
·6· · · ··judge ruled there was a substantive due process
·7· · · ··claim.··There was no appeal on that.··And that's
·8· · · ··not a factual question.··That happened.
·9· · · · · · · · ··MS. HUYSER:··I was correcting your
10· · · ··misstatement of what I had said.··That was all I
11· · · ··was doing.··The words "substantive due process
12· · · ··claim" did not come out of my mouth.
13· · · · · · · · ··JUDGE GOLDSTEIN:··One minute.
14· · · · · · · · ··All right.··I recall the superseding
15· · · ··complaints have as one of their primary allegations
16· · · ··the microbial testing claim.··Okay?··And while the
17· · · ··Court of Claims ruling is not something that I have
18· · · ··read or have before me at this point, if, in fact,
19· · · ··the Court of Claims ruling involves some of the
20· · · ··same issues that are alleged in the complaint,
21· · · ··that's relevant.··Okay?··So I will consider it.
22· · · · · · · · ··If the witness knows about the ruling,
23· · · ··fine.··But if she doesn't, then she doesn't.··So
24· · · ··you take your chances that the witness doesn't know
25· · · ··about the ruling.··Maybe she does.

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·1· · · · · · · · ··Go ahead.··Objection overruled.
·2· · · · · · · · ··Do you remember the question,
·3· · · ··Ms. Patterson?
·4· · · · · · · · ··THE WITNESS:··I apologize, I do not.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··You'll have to repeat
·6· · · ··your question, Counsel.··And try to, you know, make
·7· · · ··it a couple questions at a time.
·8· · · · · · · · ··MR. RUSSELL:··Sure.
·9· ·Q· ··(MR. RUSSELL) Ms. Patterson, do you recall that
10· · · ··Judge Murray and Judge Cameron from the Court of
11· · · ··Claims made a determination that these logbooks or
12· · · ··the tracking of the in and out times were not
13· · · ··required by any SOP rule or statute?
14· ·A· ··Yes.
15· ·Q· ··You do recall that?
16· ·A· ··Yes, I do.
17· ·Q· ··And you've testified today -- I just want to be
18· · · ··clear on this -- that there isn't anything
19· · · ··specifically in any statute, rule, or SOP that
20· · · ··would require it?
21· ·A· ··Well, Viridis's own quality management SOP,
22· · · ··facilities and environmental controls, specifically
23· · · ··states that they monitor, control, and record
24· · · ··environmental conditions, which time and
25· · · ··temperature are environmental conditions, as

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·1· · · ··required by relevant specifications, methods,
·2· · · ··processes where those things may influence the
·3· · · ··outcome of results which would speak exactly to
·4· · · ··these microbial tests both by process, by method
·5· · · ··specifications, and the fact that not recording
·6· · · ··those things would influence the outcome of
·7· · · ··results.
·8· · · · · · · · ··That has been further evidenced by the
·9· · · ··vendor claims specifically on those methods that
10· · · ··state if the method is performed outside of the
11· · · ··relevant time and temperature requirements, that
12· · · ··those results are not legally defensible and would
13· · · ··require validation.
14· ·Q· ··Your testimony is that now that the violation isn't
15· · · ··of the approved SOP for the testing of the
16· · · ··microbial aspergillus?
17· ·A· ··It's -- it's a violation of both of those things
18· · · ··together.··Because quality manuals oversee the
19· · · ··quality portion of the laboratory, and that speaks
20· · · ··to directly how those methods and those SOPs are
21· · · ··put into place in the laboratory space.··They work
22· · · ··together in concert.··Just like ISO oversees those
23· · · ··quality management requirements, those things are
24· · · ··necessary to have in place in order for a
25· · · ··laboratory to function, technically.

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·1· ·Q· ··So I'm correct when I -- when I ask or when I state
·2· · · ··that it's your testimony now that Viridis North and
·3· · · ··Viridis Laboratories are in violation of their
·4· · · ··quality management SOP?··Am I hearing you right?
·5· ·A· ··As it relates to the SOPs related to microbial,
·6· · · ··yes, sir.
·7· ·Q· ··Okay.··And so if I recall your testimony as it
·8· · · ··related to the -- I believe it was July 2020
·9· · · ··semi-annual inspection, the December 2020
10· · · ··semi-annual inspection, and the June 2021
11· · · ··semi-annual inspection, you testified to all three
12· · · ··there were no deficiencies as to the quality
13· · · ··assurances?
14· ·A· ··So this was not something that we observed during
15· · · ··any of those semi-annual inspections.
16· ·Q· ··It was a yes-or-no question.
17· · · · · · · · ··JUDGE GOLDSTEIN:··Judge, could you have
18· · · ··her answer the question, please?
19· · · · · · · · ··MS. HUYSER:··She is trying to answer the
20· · · ··question.··I don't know if the multiple portion of
21· · · ··the question makes it yes or no.
22· · · · · · · · ··MR. RUSSELL:··I'm happy to break it down
23· · · ··if that's . . .
24· · · · · · · · ··JUDGE GOLDSTEIN:··Well, Ms. Patterson,
25· · · ··can you answer the question he just posed with a

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·1· · · ··yes or no response?
·2· · · · · · · · ··THE WITNESS:··Would you ask it again,
·3· · · ··please, sir?
·4· · · · · · · · ··MR. RUSSELL:··Ms. Duda, can you read that
·5· · · ··back, please.
·6· · · · · · · · ··COURT REPORTER:··Yes.
·7· · · · · · · · ··(The record was read back by the court
·8· · · · · · · · ··reporter as follows:
·9· · · · · · · · ··"QUESTION:··And so if I recall your
10· · · · · · · · ··testimony as it related to the -- I
11· · · · · · · · ··believe it was July 2020 semi-annual
12· · · · · · · · ··inspection, the December 2020 semi-annual
13· · · · · · · · ··inspection, and the June 2021 semi-annual
14· · · · · · · · ··inspection, you testified to all three
15· · · · · · · · ··there were no deficiencies as to the
16· · · · · · · · ··quality assurances?"
17· · · · · · · · ··"ANSWER:··So this was not something that
18· · · · · · · · ··we observed during any of those
19· · · · · · · · ··semi-annual inspections.")
20· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Can you answer
21· · · ··that with a yes or no response?
22· · · · · · · · ··THE WITNESS:··I don't feel that I can.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, re-ask the
24· · · ··question in smaller portions, Counsel.
25· · · · · · · · ··MR. RUSSELL:··I'm sorry, Judge, you broke

(517) 388-3128
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·1· · · ··up a little bit.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Why don't you re-ask
·3· · · ··the questions in smaller portions if you want a
·4· · · ··yes-or-no answer.
·5· ·Q· ··(MR. RUSSELL) Ms. Patterson, in the July 2020
·6· · · ··Semi-Annual Inspection Report did you note any
·7· · · ··deficiencies as to Viridis North or Viridis
·8· · · ··Laboratories' quality assurance?
·9· ·A· ··No.
10· ·Q· ··In the December 2020 Semi-Annual Inspection Reports
11· · · ··was there any deficiency related to either of the
12· · · ··two Viridis laboratories' quality assurance?
13· ·A· ··No.
14· ·Q· ··In the June 2021 semi-annual inspection was there
15· · · ··any deficiency noted for either of the
16· · · ··laboratories' quality assurance?
17· ·A· ··No.
18· ·Q· ··You talked -- or you testified about the A2LA doing
19· · · ··an audit in 2021; correct?
20· ·A· ··Yes, sir.
21· ·Q· ··Okay.··And that's -- that's a normal procedure by
22· · · ··the accrediting body.··I believe it's biannually
23· · · ··that they do that.··Is that correct?
24· ·A· ··I believe it's annually.··I'm not sure that it's
25· · · ··regular, but I can't really speak to the details of

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·1· · · ··that.
·2· ·Q· ··And so if the accrediting body were to state that
·3· · · ··it is a completely normal occurrence when they come
·4· · · ··on site to find some kind of deficiency, would you
·5· · · ··agree with that?
·6· ·A· ··Yes.
·7· ·Q· ··And when the accrediting body identifies an issue
·8· · · ··and puts, I'm not sure if it's a corrective action
·9· · · ··or what it's called, but puts some type of
10· · · ··corrective action in place, that would also be
11· · · ··normal process; correct?
12· ·A· ··Yes.
13· ·Q· ··Okay.··And so in the instance that you spoke of, I
14· · · ··believe you said there was a -- there was an issue
15· · · ··with a temperature.··Is that right?
17· ·Q· ··Okay.··And the A2LA identified that; correct?
19· ·Q· ··Okay.··The A2LA determined that was an
20· · · ··insignificant deviation but required a correction
21· · · ··by the laboratory; is that correct?
22· ·A· ··I will not state that they noted it as
23· · · ··insignificant.
24· ·Q· ··Okay.··So if the representative from the A2LA
25· · · ··testifies at whatever hearing they testify at that

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·1· · · ··what you described was an insignificant deficiency,
·2· · · ··would you disagree with that?
·3· ·A· ··Not necessarily.
·4· ·Q· ··Okay.··So whether it's significant or
·5· · · ··insignificant, the fact that a deficiency was found
·6· · · ··and that it was asked to be corrected and that the
·7· · · ··A2LA made a determination that it was
·8· · · ··satisfactorily -- satisfactorily corrected would
·9· · · ··mean that the system was actually working
10· · · ··correctly; right?
11· ·A· ··Yes, potentially.··I mean, there should be followup
12· · · ··on the laboratories' part to correct those results
13· · · ··that may have been reported inaccurately.··But
14· · · ··there's a lot to that process there.
15· ·Q· ··Right.··But that's the way the process is meant to
16· · · ··work; correct?
17· ·A· ··Yes.
18· ·Q· ··Would you agree with me that the A2LA is an
19· · · ··accrediting body?··That's what they're meant to do
20· · · ··is to come in, identify if there's an issue, there
21· · · ··may typically be some kind of small issues, get
22· · · ··those corrected, and get the lab moving in a
23· · · ··direction where it's in compliance with all ISO
24· · · ··requirements; is that correct?
25· ·A· ··Yes.

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·1· ·Q· ··Okay.··And that's, in fact, what happened in this
·2· · · ··situation; correct?
·3· ·A· ··I can't speak to that because ISO, whomever the
·4· · · ··auditor was, had issued that noncompliance.··And
·5· · · ··then when we came on site that noncompliance had
·6· · · ··not been corrected yet.
·7· ·Q· ··When you say it hadn't been corrected yet, what
·8· · · ··proof do you have that anything that was noted in
·9· · · ··the noncompliance wasn't actually corrected?··What
10· · · ··specifically wasn't -- was not corrected?
11· ·A· ··I believe it was the input of continuous data
12· · · ··monitoring temperature logs.
13· ·Q· ··Okay.··And so you're stating that the A2LA
14· · · ··accrediting body made a determination that the
15· · · ··Viridis Laboratories and Viridis North were
16· · · ··required to have some kind of logbook?
17· ·A· ··Continuous monitoring data device.··Not necessarily
18· · · ··a logbook, no, sir.··It could be a digital tracker
19· · · ··or something of that nature.
20· ·Q· ··Okay.··And it's your testimony that whatever the
21· · · ··finding was by the accrediting body that Viridis
22· · · ··failed to do that?
23· ·A· ··At that point in time, based on what we witnessed,
24· · · ··yes, sir, that is correct.
25· ·Q· ··And so if the A2LA representative testifies that

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·1· · · ··whatever deficiency was noted was properly
·2· · · ··corrected by the Viridis laboratories, you would
·3· · · ··say that's an incorrect statement?
·4· ·A· ··No, I would hope that they had corrected that
·5· · · ··deficiency eventually, ideally sooner rather than
·6· · · ··later.
·7· ·Q· ··Okay.··So you would agree with me that whatever the
·8· · · ··minor deficiency that was noted, it was properly --
·9· · · ··it was properly fixed by Viridis?
10· ·A· ··I -- I can't specifically speak to whether or not
11· · · ··they fulfilled those requirements with A2LA.
12· ·Q· ··And would you agree with me that -- okay, let's
13· · · ··move -- I'll strike that.
14· · · · · · · · ··The review that you're talking about from
15· · · ··the A2LA, that was at some point in 2021; is that
16· · · ··correct?
17· ·A· ··Yes, sir.
18· ·Q· ··Okay.··Do you know when that was?
19· ·A· ··I believe it was September of 2021.··Early
20· · · ··September of 2021.
21· ·Q· ··Okay.··So you don't need the exact date, but fair
22· · · ··to say it was fairly close to when the CRA came on
23· · · ··site in October to both of the laboratories?
24· ·A· ··I believe, yes, it was within about six weeks.
25· ·Q· ··Right.··So the A2LA comes in, notes the one

(517) 388-3128
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·1· · · ··nonconformance, and there was no other
·2· · · ··nonconformances that were noted; is that correct?
·3· ·A· ··I can't speak to that.
·4· ·Q· ··Okay.··So the A2LA continued the accreditation for
·5· · · ··both the Viridis laboratories; correct?
·6· ·A· ··In what capacity?
·7· ·Q· ··Well, they noted a nonconformance, but they did --
·8· · · ··they are still -- they were still accredited;
·9· · · ··correct?
10· ·A· ··Yes, sir.
11· ·Q· ··They didn't pull their accreditation; correct?
13· ·Q· ··So when you came in, when you -- when the CRA came
14· · · ··in on site in October of 2021, the A2LA had just
15· · · ··been there in September 2021, and the
16· · · ··accreditation -- they remained accredited, both
17· · · ··laboratories, and what that means is they're
18· · · ··accredited, that they're complying with the ISO
19· · · ··requirements; correct?
21· ·Q· ··Okay.··So one of the things that you have -- that
22· · · ··you, the CRA, has made the allegation in the
23· · · ··superseding complaint was that there were these in
24· · · ··and out logs or time books that are required, but
25· · · ··yet when the A2LA came in in September of 2021

(517) 388-3128
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·1· · · ··there was never any deficiency noted for that; is
·2· · · ··that correct?
·3· ·A· ··Not that I am aware of as it relates to logbooks,
·4· · · ··no.
·5· ·Q· ··Okay.··And so, I mean, that is the purpose of the
·6· · · ··A2LA, right, to make sure that the lab is complying
·7· · · ··with the ISO requirements; correct?
·8· ·A· ··That is the purpose of any third-party accrediting
·9· · · ··body, yes.
10· ·Q· ··Okay.··So you would agree, then, that the -- both
11· · · ··the laboratories had proper accreditation and there
12· · · ··were not significant nonconformances with either of
13· · · ··the two laboratories?
14· ·A· ··As it relates to their accreditation, no, but that
15· · · ··doesn't necessarily mean that they were in
16· · · ··compliance with the administrative rules.
17· ·Q· ··The deviations that you have testified to as it
18· · · ··relates to microbial testing all relate to what you
19· · · ··allege or the CRA alleges are deficiencies in the
20· · · ··ISO requirements, comply with ISO; correct?
21· ·A· ··They're related to the inability of the laboratory
22· · · ··to demonstrate or the evidence where the laboratory
23· · · ··did not demonstrate that they were in compliance
24· · · ··with their standard operating procedures both as it
25· · · ··relates to the method itself as well as their own

(517) 388-3128
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·1· · · ··quality management procedures.
·2· ·Q· ··Okay.··Well, I don't want to be redundant, but
·3· · · ··you've testified that there's nothing in the SOP
·4· · · ··that requires any type of logbook, a statute or the
·5· · · ··rule; correct?
·6· ·A· ··So I will reiterate again that the quality manual,
·7· · · ··the specifications that were outlined there, the
·8· · · ··specifications that were outlined by the vendor,
·9· · · ··and the method require that the laboratory stay
10· · · ··within a very small temperature range and a very
11· · · ··small time range.
12· · · · · · · · ··The laboratory, based on the logs that we
13· · · ··saw related to temperature, demonstrated that they
14· · · ··were outside of the approved temperature as it was
15· · · ··validated, and, therefore, were not following the
16· · · ··SOP.··And additionally, they were unable to provide
17· · · ··any evidence that they were maintaining compliance
18· · · ··with the time requirements as it related to the
19· · · ··SOP.
20· ·Q· ··Again, what you're describing are all what you, the
21· · · ··CRA, deems to be ISO deficiencies.··Am I right?
22· ·A· ··They're SOP deficiencies.
23· ·Q· ··But you've testified that these are not
24· · · ··specifically expressly stated in the SOP; correct?
25· ·A· ··They're deficiencies that are inherently related to

(517) 388-3128
Page 635
·1· · · ··the SOP given the strict requirements that are
·2· · · ··outlined by both the method and the vendor and the
·3· · · ··quality manual itself.··And those do, in fact, tie
·4· · · ··back to ISO requirements.
·5· ·Q· ··You testified about what you considered to be an
·6· · · ··adversarial relationship that started at some
·7· · · ··point; is that correct?
·8· ·A· ··What I felt was adversarial interactions in
·9· · · ··relationship to Viridis, yes, sir.
10· ·Q· ··Okay.··I recall from your testimony that in
11· · · ··November 2020 that you were only emailing with
12· · · ··Viridis because you wanted a written record of
13· · · ··that; is that correct?
14· ·A· ··Yes, sir.
15· ·Q· ··Okay.··So in November of 2020 there were no --
16· · · ··there wasn't an investigation at that point related
17· · · ··to potency or microbials or anything like that;
18· · · ··correct?
19· ·A· ··At that point in time we were simply asking
20· · · ··questions back and forth with Viridis, that is
21· · · ··correct.
22· ·Q· ··Okay.··So I'm confused as to why you would have
23· · · ··testified that you needed to put things in writing.
24· · · ··The last semi-annual inspection that you had was
25· · · ··July 2020.··There was no deficiencies noted at all.

(517) 388-3128
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·1· · · ··November 2020, it's my understanding, there's not
·2· · · ··any investigations that are going on, but your
·3· · · ··testimony is that you felt that you had to have
·4· · · ··everything in writing with the Viridis
·5· · · ··laboratories.··Can you explain that to me?
·6· ·A· ··Absolutely.··So in working with Viridis
·7· · · ··laboratories, despite having what I felt was a
·8· · · ··fairly cordial relationship, that was limited to
·9· · · ··when they were receiving approvals or when they
10· · · ··were receiving something that they would deem
11· · · ··potentially favorable from the Agency.
12· · · · · · · · ··However, I believe I noted back in 2019
13· · · ··potentially to my manager at the time, Julie
14· · · ··Kluytman, that any time that we asked for
15· · · ··additional data or we asked a question, we got what
16· · · ··felt like a very adversarial or kind of a pushback
17· · · ··response from the licensee.··And that remains true
18· · · ··until this day.
19· ·Q· ··So in that November 2020 to December 2020 email
20· · · ··chain that we went through, which is a lengthy
21· · · ··chain back and forth, in your opinion was that an
22· · · ··adversarial response from Dr. Michele Glinn to you?
23· ·A· ··Not necessarily adversarial in those instances,
24· · · ··but, as I believe I talked with Ms. Huyser about,
25· · · ··there was a lot of back and forth.··It felt like

(517) 388-3128
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·1· · · ··there were portions of the questions that were not
·2· · · ··being answered.··And it really just -- it felt like
·3· · · ··obfuscation on behalf of the licensee.··And so I
·4· · · ··could take that to mean that they were being
·5· · · ··adversarial.
·6· ·Q· ··So did you take it to mean they were being
·7· · · ··adversarial?
·8· ·A· ··I mean, in some part.··I don't think that that
·9· · · ··changed any of my interactions with them, but it
10· · · ··did require that I get those things in writing so
11· · · ··that there could be a written record so that that
12· · · ··couldn't be altered later on.
13· ·Q· ··Was there anything specifically in the emails back
14· · · ··and forth that you could identify as adversarial?
15· ·A· ··I would have to look at them specifically in order
16· · · ··to go through them all.··But one thing that comes
17· · · ··to mind is the fact that in June of 2021 when we
18· · · ··were on site physically with Dr. Glinn herself I
19· · · ··reached out either later that day or the following
20· · · ··day.··I asked her for the method that they were
21· · · ··using in the laboratory space, and she provided me
22· · · ··a method that was submitted back in November of
23· · · ··2020.··And so that certainly felt very adversarial.
24· · · · · · · · ··And then I had to reach back out to her
25· · · ··and say "Hey, this is not what we witnessed you

(517) 388-3128
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·1· · · ··doing on site.··Please provide me the method that
·2· · · ··you're actually using."··And it wasn't until either
·3· · · ··10 days or two weeks later that she actually
·4· · · ··provided that to me.
·5· · · · · · · · ··So, yes, I would say that that felt
·6· · · ··adversarial.
·7· ·Q· ··You testified on redirect that there is some kind
·8· · · ··of supervision for each of the LSSs and then you
·9· · · ··also have that as well; is that correct?
10· ·A· ··Yes, sir.
11· ·Q· ··Okay.··And so I guess I want to understand that a
12· · · ··little bit better.
13· · · · · · · · ··When one of the LSSs compiles
14· · · ··information, say one of the exhibits that we looked
15· · · ··at with the Excel as it relates to the aspergillus
16· · · ··rates, now, I'm not sure that you knew for certain
17· · · ··who compiled that, but is it your testimony, then,
18· · · ··if someone prepared that information, then someone
19· · · ··else would be tasked with looking at the underlying
20· · · ··Metrc data and making sure that the data that was
21· · · ··in the document itself, that it was correct and
22· · · ··accurate?
23· ·A· ··Yes, sir.··And also to clarify, we would never use
24· · · ··that data as fact and evidence in an investigation
25· · · ··necessarily.··You know, just because there are data

(517) 388-3128
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·1· · · ··anomalies doesn't mean that it warrants further
·2· · · ··followup.
·3· ·Q· ··Well, I may have misunderstood your testimony then.
·4· · · ··I thought both as it related to potency and
·5· · · ··aspergillus that you testified that there were
·6· · · ··anomalies and that you looked at those to make a
·7· · · ··determination of whether an investigation was
·8· · · ··necessary.
·9· ·A· ··Sure.··And -- and also if we were to go on site and
10· · · ··find that the laboratory was complying with their
11· · · ··SOPs and there was no reason to investigate
12· · · ··further, then that would be one of those instances
13· · · ··where we said, you know, we had a complaint, we
14· · · ··found no evidence of violation of the
15· · · ··administrative rules, and we would close it out
16· · · ··accordingly.
17· · · · · · · · ··JUDGE GOLDSTEIN:··It looks like a good
18· · · ··time to break, Counsel.··Did you have further
19· · · ··cross-exam -- or recross?
20· · · · · · · · ··MR. RUSSELL:··No, Your Honor.
21· · · · · · · · ··JUDGE GOLDSTEIN:··Did you have further
22· · · ··redirect, Ms. Huyser?
23· · · · · · · · ··MS. HUYSER:··Just one question.··Excuse
24· · · ··me.··One question.
25· · · · · · · · ··JUDGE GOLDSTEIN:··Go ahead.

(517) 388-3128
Page 640
·2· · · · · · · ·REDIRECT EXAMINATION, CONTINUING
·3· ·BY MS. HUYSER:
·4· ·Q· ··It was asked of you, Ms. Patterson, about the July
·5· · · ··of 2020, December of 2020, and June of 2021, that
·6· · · ··there were no deficiencies for quality assurance
·7· · · ··noted.
·8· ·A· ··Yes.
·9· ·Q· ··Then tell me what it is that you believe that -- or
10· · · ··how you believe that there is quality assurance
11· · · ··issues if there weren't any deficiencies that were
12· · · ··noted.
13· ·A· ··So during that period of time, much like compliance
14· · · ··with SOPs, it simply required that the laboratory
15· · · ··have a -- a quality manual in place that would meet
16· · · ··the requirements of ISO and that would meet the
17· · · ··requirements of the regulatory body.··At that
18· · · ··period in time they did have those quality manuals
19· · · ··in place, but that does not necessarily mean that
20· · · ··we assessed whether or not they were following them
21· · · ··in practice in their daily SOPs or various methods.
22· · · · · · · · ··MS. HUYSER:··Thank you.··I have nothing
23· · · ··further.
24· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··All right.··May
25· · · ··Ms. Patterson be excused as the witness?··Except

(517) 388-3128
Page 641
·1· · · ··for purposes of rebuttal I would guess.
·2· · · · · · · · ··MR. RUSSELL:··Yes, Your Honor, I believe
·3· · · ··so.
·4· · · · · · · · ··MS. HUYSER:··Yes, Your Honor.
·6· · · ··Ms. Patterson, thank you very much --
·7· · · · · · · · ··THE WITNESS:··You're welcome.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··-- for your testimony
·9· · · ··today and the last couple days.
10· · · · · · · · ··(The witness was excused.)
11· · · · · · · · ··JUDGE GOLDSTEIN:··You know, we've been
12· · · ··looking for the exhibits, Counsel, and I'm not
13· · · ··certain if there's a filter block on the -- on our
14· · · ··end, but I'm going to have you try sending them
15· · · ··directly to my secretary.··Dhagar@michigan.gov.
16· · · ··D-h-a-g-a-r.
17· · · · · · · · ··MR. RUSSELL:··D. Hagar,
18· · · ··d-h-a-g-e-r@michigan.gov.
19· · · · · · · · ··We'll do that, Your Honor.··And if it
20· · · ··doesn't go through, I'm happy to have them put on a
21· · · ··thumb drive and have someone take them over to your
22· · · ··office.
23· · · · · · · · ··JUDGE GOLDSTEIN:··It's Hagard,
24· · · ··h-a-g-a-r-d@michigan.gov.
25· · · · · · · · ··MR. SCHUMACHER:··H-a-g-a-r-d@michigan.gov

(517) 388-3128
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·1· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··We will
·2· · · ··adjourn for the day.··We'll see everybody at 9:00
·3· · · ··in the morning.··Okay?
·4· · · · · · · · ··MS. HUYSER:··Thank you, Your Honor.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··You're welcome.··We're
·6· · · ··off the record at 4:34 PM.··Have a good evening.
·7· · · · · · · · ··MR. RUSSELL:··Thank you.
·8· · · · · · · · ··(Record closed at 4:34 PM)
·9· · · · · · · · · ··*· ··*· ··*· ··*· ··*
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(517) 388-3128
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·1· · · · · · · · ·CERTIFICATE OF NOTARY PUBLIC

· ··
·2· ·
· ··
·3· · · ··I certify that this transcript, consisting of pages
· ··
·4· ·428-643, is a complete, true, and correct transcript of the
· ··
·5· ·proceedings and testimony taken in this case on May 23,
· ··
·6· ·2023.
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12· ·June 5, 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
· ··
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(517) 388-3128
·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
·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
18· · · · · Respondents.
· · · · · · · · · · · · · · · · · · · · · Case Type: MMF
19· · · · · · · · · · · · · · · · · · · · Disciplinary Hearings
· · ··
20· · · · · · · · · · · · · · · · · · · · Filing Type: Formal
· · ·· _____________________________/· · ·Complaint
21· ··
· · ··
22· · · · · · · · · · · · · · VOLUME 4
· · ··
23· ·· REMOTE PROCEEDINGS HELD IN THE ABOVE-ENTITLED MATTER
· · ··
24· ·· BEFORE ADMINISTRATIVE LAW JUDGE STEPHEN B. GOLDSTEIN
· · ··
25· · · · · · · ·· WEDNESDAY, MAY 24, 2023, 9:02 AM
Page 645
·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)
· · · · ··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 Michigan CRA
· ··
13· ·
· ··
14· ·ALSO PRESENT:
· ··
15· · · ··Michele Glinn
· · · · ··Erika Marzorati
16· · · ··Greg Michaud
· · · · ··Lorri Rosier
17· ·
· ··
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· ··
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· ··
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· ··
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· ··
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· ··
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· ··
24· ·
· ··
25· ·REPORTED BY: Suzanne Duda, CSR-3199, RPR, CRR

(517) 388-3128
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·1· · · · · · · · · · ··INDEX OF WITNESSES
·2· ·WITNESS:
·3· ·NOAH ROSENZWEIG· · · · · · · · · · · · · · · · · ··PAGE
·4· · · ··Direct Examination by Ms. Huyser· · · · · · · ·650
·5· · · ··Voir Dire Examination by Mr. Schumacher· · · ··658
·6· · · ··Direct Examination, Cont. by Ms. Huyser· · · ··663
·7· ·
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13· ·
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15· ·
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18· ·
19· ·
20· ·
21· ·
22· ·
23· ·
24· ·
25· ·

(517) 388-3128
Page 647
·1· · · · · · · · · · ··INDEX OF EXHIBITS
·2· ·CRA EXHIBITS ADMITTED:· · · · · · · · · · · · · · ·PAGE
·3· · · ··CRA Exhibit 54· · · · · · · · · · · · · · · · ·657
·4· · · ··CRA Exhibit 19· · · · · · · · · · · · · · · · ·700
·5· · · ··CRA Exhibit 15· · · · · · · · · · · · · · · · ·712
·6· · · ··CRA Exhibit 21· · · · · · · · · · · · · · · · ·719
·7· · · ··CRA Exhibit··8· · · · · · · · · · · · · · · · ·730
·8· · · ··CRA Exhibit··9· · · · · · · · · · · · · · · · ·733
·9· · · ··CRA Exhibit 22· · · · · · · · · · · · · · · · ·738
10· · · ··CRA Exhibit 23· · · · · · · · · · · · · · · · ·740
11· · · ··CRA Exhibit 24· · · · · · · · · · · · · · · · ·741
12· · · ··CRA Exhibit 38· · · · · · · · · · · · · · · · ·759
13· · · ··CRA Exhibit 39· · · · · · · · · · · · · · · · ·761
14· · · ··CRA Exhibit 40· · · · · · · · · · · · · · · · ·765
15· · · ··CRA Exhibit 41· · · · · · · · · · · · · · · · ·767
16· · · ··CRA Exhibit 42· · · · · · · · · · · · · · · · ·770
17· · · ··CRA Exhibit 43· · · · · · · · · · · · · · · · ·773
18· · · ··CRA Exhibit 44· · · · · · · · · · · · · · · · ·775
19· · · ··CRA Exhibit 45· · · · · · · · · · · · · · · · ·776
20· · · ··CRA Exhibit 46· · · · · · · · · · · · · · · · ·778
21· · · ··CRA Exhibit 49· · · · · · · · · · · · · · · · ·781
22· · · ··CRA Exhibit 51· · · · · · · · · · · · · · · · ·782
23· · · ··CRA Exhibit 47· · · · · · · · · · · · · · · · ·783
24· ·
25· ·

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

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Any preliminary
·2· · · ··matters before we start this morning?··For the
·3· · · ··Agency?
·4· · · · · · · · ··MS. HUYSER:··None for the Agency, Your
·5· · · ··Honor.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··For Viridis?
·7· · · · · · · · ··MR. RUSSELL:··None, Your Honor.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Very good.
·9· · · · · · · · ··I believe we left off and we had finished
10· · · ··with Ms. Patterson yesterday.··And is
11· · · ··Mr. Rosenzweig your next witness?
12· · · · · · · · ··MS. HUYSER:··Yes, he is, Your Honor.
13· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Good morning,
14· · · ··sir.··Could you raise your right hand for me?
15· · · · · · · · ··Do you solemnly swear or affirm to tell
16· · · ··the truth, the whole truth, and nothing but the
17· · · ··truth?
18· · · · · · · · ··DR. ROSENZWEIG:··I do.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Could you state and
20· · · ··spell your first and last name for me, please.
21· · · · · · · · ··THE WITNESS:··Noah, N-o-a-h, Rosenzweig,
22· · · ··R-o-s-e-n-z-w-e-i-g.
23· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Thank you,
24· · · ··sir.
25· · · · · · · · ··All right, Ms. Huyser, go ahead.

(517) 388-3128
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·2· · · · · · · · ··JUDGE GOLDSTEIN:··You're welcome.
·3· · · · · · · · · · ··DIRECT EXAMINATION
·4· ·BY MS. HUYSER:
·5· ·Q· ··Good morning, Dr. Rosenzweig.··Can you please tell
·6· · · ··me where you're employed?
·7· ·A· ··I'm employed at the CRA as a laboratory scientist
·8· · · ··specialist, Cannabis Regulatory Agency.
·9· ·Q· ··Okay.··And how long have you been employed with the
10· · · ··CRA?
11· ·A· ··Since 6/26/2020 I believe?··So almost three years.
12· ·Q· ··Can you tell me a little bit about what your
13· · · ··educational background is?
14· ·A· ··I received my bachelor's of science from Eastern
15· · · ··Michigan, and my major was biology and my minor was
16· · · ··chemistry.··I also received my master's of science
17· · · ··at Eastern Michigan University in biology, and my
18· · · ··research was in mycology which is the study of
19· · · ··fungi.··And after I received my master's I had
20· · · ··earned my doctorate from the University of
21· · · ··Wisconsin-Madison in plant pathology.
22· ·Q· ··And tell me a little bit about what plant pathology
23· · · ··is.
24· ·A· ··So plant pathology is the study of diseases and the
25· · · ··cause of diseases in plants, and mostly it involves

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·1· · · ··bacteria and fungi and viruses and nematodes that
·2· · · ··cause disease in plants.··And nematodes are small
·3· · · ··worms in the soil.
·4· ·Q· ··Thank you.··So in order to get your doctorate what
·5· · · ··type of things did you have to do to be qualified
·6· · · ··or complete the program?
·7· ·A· ··So I had to take a certain amount of core courses,
·8· · · ··and many of those involved topics that are related
·9· · · ··directly to plant pathology which includes plant
10· · · ··breeding, plant genetics, statistics, experimental
11· · · ··design.··And then each -- training in each one of
12· · · ··the specific microbes that cause bacteria which --
13· · · ··I mean that cause disease which are bacteria,
14· · · ··fungi, viruses, and nematodes.
15· ·Q· ··And after getting your doctorate did you continue
16· · · ··to do research along -- in the field of plant
17· · · ··pathology?
18· ·A· ··Yes.··So subsequent to graduation I went to work at
19· · · ··the University of California at Berkley, and there
20· · · ··I worked in plant pathology but I worked in forest,
21· · · ··crops, trees, forest, and also ornamental and
22· · · ··landscape plants.
23· · · · · · · · ··And from there I moved to the University
24· · · ··of Minnesota, the Twin Cities campus there in the
25· · · ··department of pathology.··Oh, I should mention the

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·1· · · ··department I worked in at Berkley was environmental
·2· · · ··science, policy and management.··And from there I
·3· · · ··went to the department of plant pathology at the
·4· · · ··University of Minnesota where I worked in the
·5· · · ··potato breeding and pathology group.
·6· · · · · · · · ··And subsequent to that I went to -- came
·7· · · ··to work at Michigan State University where I worked
·8· · · ··in mostly potato pathology, so the diseases in
·9· · · ··potato crops.··I was an assistant professor there
10· · · ··but also worked in a number of other crops
11· · · ··including sugar beets and some other minor
12· · · ··vegetable crops that we grow in Michigan like
13· · · ··turnips and rutabaga.
14· ·Q· ··And were you ultimately a professor or teaching
15· · · ··while you were at Michigan State University as
16· · · ··well?
17· ·A· ··Yeah, I taught plant pathology, the plant pathology
18· · · ··course, at Michigan State which is required for
19· · · ··most of the ag disciplines there.··And I also ran a
20· · · ··research program, and that involved getting grant
21· · · ··funding.··I think I received maybe about 12 million
22· · · ··in grant funding at MSU.··And so I ran my own
23· · · ··research lab there.
24· ·Q· ··And that was going to be my next question.··So tell
25· · · ··me about what you -- when you say you ran your own

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·1· · · ··research lab, you have hands-on experience with the
·2· · · ··equipment in the laboratory and testing and
·3· · · ··different procedures that are done in various
·4· · · ··laboratories?
·5· ·A· ··Yes, I do.··So, you know, to maintain a research
·6· · · ··program you must, you know, conduct research,
·7· · · ··publish that research, and also acquire funding to
·8· · · ··support that research, train grad students,
·9· · · ··undergrad students, technicians, and managers.··And
10· · · ··that lab was a BSL2, which is biosafety level 2.
11· · · ··And we were also under the USDA for exotic
12· · · ··pathogens which is pathogens that may not be
13· · · ··endemic or found here and they will come in.··So we
14· · · ··had to have certain control to make sure that we
15· · · ··don't get any of those pathogens to escape into
16· · · ··Michigan.··So . . .
17· ·Q· ··And you went from working at Michigan State
18· · · ··University to working at the CRA; correct?··Or was
19· · · ··there anything in between?
20· ·A· ··No, there was nothing in between, no.
21· ·Q· ··And have you ever -- explain to me a little bit
22· · · ··about how you connect your past job experience to
23· · · ··what you do now.
24· ·A· ··So right -- so when I worked in MSU and all the
25· · · ··other places I mostly worked -- I've worked on

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·1· · · ··other pathogens but mostly worked with fungi, and I
·2· · · ··worked on detection of those fungi, identifying
·3· · · ··those fungi.··And a lot of the same techniques that
·4· · · ··we either used or developed at MSU that they're
·5· · · ··applied in testing for contaminants at -- in the
·6· · · ··regulated cannabis space.
·7· ·Q· ··And have you ever been published?
·8· ·A· ··Yeah.··Yes, I have.
·9· ·Q· ··And just if you were to give me a general -- a
10· · · ··general overview of what you've been published in
11· · · ··and put it into a category, what have you been
12· · · ··published in?
13· ·A· ··So I have been published -- I've published in --
14· · · ··let's see.··It's kind of a long list, so I'll try
15· · · ··to distill this.··But, I guess, prior to coming
16· · · ··here I will say that I was an international expert
17· · · ··in -- and widely published in the area of fungicide
18· · · ··resistance, which is similar to antibiotic
19· · · ··resistance in drugs, so it's the development of --
20· · · ··of specific fungi to the pesticide that it's used
21· · · ··to control that fungi or to manage that fungi.
22· · · · · · · · ··So not only did I conduct tests to, you
23· · · ··know, look at how they respond to different fungi
24· · · ··but also to determine what the genetic mechanism is
25· · · ··that causes that resistance.··I don't think I need

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·1· · · ··to go into those details.
·2· ·Q· ··No.··Thank you though.
·3· · · · · · · · ··Since you've been working with the CRA
·4· · · ··have you been published?
·5· ·A· ··Yes, I have, actually.
·6· ·Q· ··And doing what have you been published?
·7· ·A· ··So I had left some projects, and that was working
·8· · · ··on an exotic pathogen of potato.··It was a bacteria
·9· · · ··and it was causing severe losses in the potato crop
10· · · ··nationally.··And I was on a project with multiple
11· · · ··institutions.··It's called a specialty crop
12· · · ··research initiative.··And those are run through the
13· · · ··USDA, United States Department of Agriculture.
14· · · · · · · · ··MS. HUYSER:··Thank you.··I'm going to
15· · · ··share my screen if I'm able to, Your Honor.
16· · · · · · · · ··JUDGE GOLDSTEIN:··I'll make sure it's set
17· · · ··correctly.
18· · · · · · · · ··Okay, you should be fine now.
19· · · · · · · · ··MS. HUYSER:··Thank you.
20· ·Q· ··(MS. HUYSER) Okay, let me make sure I've got this
21· · · ··here.
22· · · · · · · · ··Okay.··Can you see what is on the screen
23· · · ··here and is marked as proposed Exhibit 54?
24· ·A· ··That's my CV.
25· ·Q· ··Okay.··I am going to scroll through slowly just to

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·1· · · ··make sure.··I know you are very accomplished so
·2· · · ··there is a lot here.··If there's any changes or
·3· · · ··alterations that you notice from in the form in
·4· · · ··which you provided it to me please let me know.
·5· · · ··And if you would like me to slow down, please let
·6· · · ··me know that too.
·7· ·A· ··Sarah, if you can go back up real quick to the top
·8· · · ··of my publication list?
·9· · · · · · · · ··Okay.··Yeah, I just wanted to make sure
10· · · ··it was up to . . .
11· ·Q· ··Okay.··Like I said, if you need me to slow down let
12· · · ··me know, but I know you're, obviously, familiar.
13· · · · · · · · ··And up here is this a current and
14· · · ··up-to-date list of all of the organizations that
15· · · ··you were involved in or professional meetings that
16· · · ··you have spoke at?
17· ·A· ··Yeah.
18· ·Q· ··Are you involved in any organizations pertaining to
19· · · ··marijuana at this point?
20· ·A· ··No, I'm not.··No professional organizations, no.
21· ·Q· ··But you -- are you still involved in those that
22· · · ··pertain to the field of plant pathology?
23· ·A· ··Yep.··Yeah.
24· ·Q· ··And what are those?
25· ·A· ··The American Phytopath Society.

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·1· ·Q· ··And what does that do?··What's a phytopath?
·2· ·A· ··So that's just a fancy word for plant pathogens.
·3· ·Q· ··So, obviously, I scrolled through pretty quickly,
·4· · · ··but you said you recognized this as your CV.
·5· · · · · · · · ··Have there been any changes or
·6· · · ··alterations to it from the way that you've provided
·7· · · ··it to me?
·8· ·A· ··I don't believe so.
·9· · · · · · · · ··MS. HUYSER:··Okay.··At this point in time
10· · · ··I would ask that CRA proposed Exhibit 54 be
13· · · · · · · · ··MR. SCHUMACHER:··No objection to the CV,
14· · · ··Your Honor, I would just ask to inquire to the
15· · · ··extent he's being qualified as an expert.
16· · · · · · · · ··JUDGE GOLDSTEIN:··I don't think she's
17· · · ··moved for that yet.
18· · · · · · · · ··No objection to the CV though?
19· · · · · · · · ··MR. SCHUMACHER:··No objection to the CV.
20· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··CRA Exhibit
21· · · ··54 is admitted.
22· · · · · · · · ··MS. HUYSER:··Thank you, Your Honor.
23· · · · · · · · ··(CRA Exhibit 54 is admitted.)
24· · · · · · · · ··MS. HUYSER:··Based on the testimony from
25· · · ··Dr. Rosenzweig and the CV that's pretty extensive

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·1· · · ··that's been presented we're asking that this court
·2· · · ··authorize Dr. Rosenzweig as an expert in the field
·3· · · ··of plant pathology.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Any objection, Counsel?
·5· · · · · · · · ··MR. SCHUMACHER:··May I inquire?
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Voir dire?··Sure.··Go
·7· · · ··ahead.
·8· · · · · · · · · ··VOIR DIRE EXAMINATION
·9· ·BY MR. SCHUMACHER:
10· ·Q· ··Can you let me know how to say your last name?··I
11· · · ··don't want to mispronounce it.
12· ·A· ··Rosenzweig.
13· ·Q· ··Rosenzweig?
14· ·A· ··Yep.
15· ·Q· ··All right.··So, again, let's go piece by piece
16· · · ··here.··Let's start with your education.
17· · · · · · · · ··Mr. Rosenzweig, you said you have a
18· · · ··bachelor's degree in biology and a minor in
19· · · ··chemistry; is that correct?
21· ·Q· ··All right.··So you had some formal education in
22· · · ··chemistry, but it wasn't enough to get a major.··Am
23· · · ··I understanding that correctly when you say minor?
24· ·A· ··Yeah.
25· ·Q· ··So --

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·1· ·A· ··Yeah, that's correct.
·2· ·Q· ··So what is the highest level of chemistry you've
·3· · · ··taken?
·4· ·A· ··Senior level chemistry in undergrad.
·5· ·Q· ··All right.··So you've probably taken biochemistry?
·6· ·A· ··Yep.
·7· ·Q· ··How about physical chemistry?
·8· ·A· ··I don't think I took P chem, no.
·9· ·Q· ··All right.··So basic chemistry as well?
10· ·A· ··Yep, regular and organic.
11· ·Q· ··And then when you went into -- while you were in
12· · · ··your undergraduate studies did you have any study
13· · · ··with chemistry dealing with cannabis or hemp or
14· · · ··anything that's cannabinoid related?
15· ·A· ··No.
16· ·Q· ··All right.··So was it in undergrad or in your
17· · · ··graduate programs that you took statistics or had
18· · · ··training in statistics?
19· ·A· ··Graduate.
20· ·Q· ··All right.··So moving into graduate, again, your
21· · · ··master's is in did you say mycology or . . .?
22· ·A· ··Yeah, mycology.··It's the study of fungi.
23· ·Q· ··All right.··Any other specialties?
24· ·A· ··Plant pathology.
25· ·Q· ··Okay.··So in -- your master's is in mycology and

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·1· · · ··plant pathology.··And you said you had statistics?
·2· ·A· ··In my PhD, yep.
·3· ·Q· ··In your PhD.··Okay.··So not in the master's
·4· · · ··program?
·5· ·A· ··No.
·6· ·Q· ··All right.··So I guess same question for your
·7· · · ··master's program.··Did you have any training
·8· · · ··specific to cannabis?
·9· ·A· ··No, I did not.
10· ·Q· ··Have you ever --
11· ·A· ··But I did have training in both plant anatomy,
12· · · ··plant physiology, and some plant breeding.
13· ·Q· ··And so let's go into your PhD program.··Again, it's
14· · · ··in plant pathology, and you know your education
15· · · ··better than I do.
16· · · · · · · · ··Was there any other expertise that you
17· · · ··have from the PhD program?
18· ·A· ··Beyond statistics and plant breeding and
19· · · ··experimental design it's pretty much, but there's a
20· · · ··lot of -- plant pathology is quite
21· · · ··interdisciplinary, so it combines a lot of
22· · · ··different sciences into that discipline.··So it can
23· · · ··be biochem, it can be chemistry, so -- yeah.
24· ·Q· ··And so statistics -- I kind of want to touch base
25· · · ··on this.··Were you trained in statistics that were

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·1· · · ··based on basic mathematic principles or calculus
·2· · · ··based?
·3· ·A· ··I can't recall the details on what that is but it's
·4· · · ··a certain segment that you need to take.··You need
·5· · · ··to take a full year of statistics to get your
·6· · · ··degree in plant pathology at Wisconsin.
·7· ·Q· ··Okay.··So -- and this isn't trying to trick you,
·8· · · ··I'm just trying to understand the bounds of your
·9· · · ··statistical knowledge.
10· · · · · · · · ··So did you take differential equations?
11· ·A· ··That was I took in calculus.
12· ·Q· ··That was part of your calculus or a different
13· · · ··course?
14· ·A· ··That was part of calculus, yes, in my undergrad.
15· ·Q· ··Okay.··So that was in undergrad, it wasn't in your
16· · · ··graduate program?
17· ·A· ··No.
18· ·Q· ··All right.··So I'm not as familiar with EMU's
19· · · ··programs.··How many levels of calculus did you
20· · · ··have?··Did you have Calc 1, Calc 2, Calc 3?··Like
21· · · ··how many dimensions did you get into?··Did you get
22· · · ··into three-dimensional calculations or just stay on
23· · · ··a planar two-dimensional?
24· ·A· ··Probably just Calc 1.
25· ·Q· ··Okay.··So not in -- you didn't get into the Zed

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·1· · · ··Axis, for instance, when you're trying to figure
·2· · · ··out differentiation, anything like that?
·3· ·A· ··I can't recall, it's been a while.
·4· ·Q· ··Okay.··So is it fair to say, then, that your
·5· · · ··statistics probably was calculus based?··It was
·6· · · ··probably just normal arithmetic?
·7· ·A· ··It was related to how to set up proper design
·8· · · ··without bias for field -- field research but mostly
·9· · · ··just in biological studies.··So how do you set up a
10· · · ··study to make sure that your statistics is rigorous
11· · · ··enough to explain whether there's no difference
12· · · ··between your treatments or difference between your
13· · · ··treatments.
14· ·Q· ··And so part of that, for instance, would be
15· · · ··including modeling and possibly curves for data
16· · · ··analysis?
17· ·A· ··Yes, comparison analysis.
18· ·Q· ··All right.··And so as part of that, for instance,
19· · · ··if you were to look at, say, a bell curve and show
20· · · ··that a data fell along a bell curve --
21· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel --
22· ·Q· ··(MR. SCHUMACHER) -- that would be correct?
23· · · · · · · · ··JUDGE GOLDSTEIN:··Counsel, I'm going to
24· · · ··interject.··This is way beyond voir dire.
25· · · · · · · · ··Do you have an objection to this witness

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·1· · · ··being recognized as an expert in plant pathology,
·2· · · ··yes or no.
·3· · · · · · · · ··MR. SCHUMACHER:··In plant pathology,
·4· · · ··generally no.
·6· · · · · · · · ··MR. SCHUMACHER:··In terms of cannabis,
·7· · · ··yes.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··I think he was
·9· · · ··offered as an expert in plant pathology not as an
10· · · ··expert in cannabis.
11· · · · · · · · ··Is that correct, Ms. Huyser?
12· · · · · · · · ··MS. HUYSER:··That is correct, Your Honor.
13· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··The
14· · · ··tribunal will recognize -- Doctor, you have a PhD;
15· · · ··correct?
16· · · · · · · · ··THE WITNESS:··Yes.
17· · · · · · · · ··JUDGE GOLDSTEIN:··Dr. Rosenzweig as an
18· · · ··expert in plant pathology under Rule 702 of the
19· · · ··Michigan Rules of Evidence.
21· · · · · · · · ··JUDGE GOLDSTEIN:··You're welcome.
22· · · · · · · ··DIRECT EXAMINATION, CONTINUING
24· ·Q· ··Dr. Rosenzweig, as you've gone through with, in
25· · · ··general, all of your educational background how

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·1· · · ··many years did you spend working in a laboratory?
·2· ·A· ··I think around 1997?··So I don't know.··Is that
·3· · · ··almost 30 years now?··Gosh.
·4· ·Q· ··Getting there.
·5· ·A· ··Yeah.··So about, what, 26 years in the lab space?
·6· ·Q· ··And in the laboratory what types of things do you
·7· · · ··do -- dumb this down for me.··I'm not a scientist,
·8· · · ··so tell me what we do in a laboratory setting and
·9· · · ··how it involves analytical -- analysts, how it
10· · · ··involves processes.··Tell me, like, generally what
11· · · ··do you do in a lab setting.
12· ·A· ··I think, broadly, we conduct experiments.··We test
13· · · ··hypothesis.··So if we want to see that whatever
14· · · ··we're doing is actually having an effect, let's say
15· · · ··we're testing -- let me go back to what I talked
16· · · ··about.··We want to test a certain pesticide and see
17· · · ··if a certain pathogen responds to that pesticide
18· · · ··then we would set up an experiment.··We would prior
19· · · ··set out our hypothesis.··There's a null hypothesis
20· · · ··which means there's no change or an alternative
21· · · ··hypothesis which means whatever we tested did
22· · · ··affect that.
23· · · · · · · · ··I mean, I -- I think that's broadly what
24· · · ··we do.··And we use the, you know, the scientific
25· · · ··method to perform those tests and those

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·1· · · ··experiments.
·2· ·Q· ··And what type of steps -- do you analyze data?
·3· · · ··You're performing all these tests.··What do you do
·4· · · ··with them?
·5· ·A· ··Well, so we would first gather that data.··Again,
·6· · · ··prior to setting up these experiments we want to
·7· · · ··make sure that we have the proper experimental
·8· · · ··design.··Once we have that, the experiment design,
·9· · · ··then we would run that experiment.··And then yes,
10· · · ··we would typically -- I think almost all of my
11· · · ··published research is based on statistical
12· · · ··analysis.··So then we would analyze that data to
13· · · ··see if there's any differences between, as I said,
14· · · ··the null hypothesis and the alternative hypothesis
15· · · ··which is just does this do anything or does it not
16· · · ··do anything.
17· ·Q· ··And when you're looking at a study or you're
18· · · ··looking at something along those lines, almost
19· · · ··anything scientific, do you keep an open mind, or
20· · · ··do you have your -- or do you have a projected goal
21· · · ··that you're trying to reach?
22· ·A· ··No, there's no goal.··I mean, the goal is to
23· · · ··perform that experiment.··But I think what you're
24· · · ··asking is do we go into it with, you know, an
25· · · ··a priori, which is, you know, before we even go in

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·1· · · ··we know what the result is.··We don't go in like
·2· · · ··that.··So it's nonbiased.··We just -- whatever the
·3· · · ··results say, that's how we interpret it.
·4· ·Q· ··Are you able to carry this education and experience
·5· · · ··that you've had for almost coming up on 26 years or
·6· · · ··up until the CRA into the job as an LSS?
·7· ·A· ··Yeah.··Yep.
·8· ·Q· ··Tell me how they parallel or how you see them
·9· · · ··working together.
10· ·A· ··Well, I think, you know -- you know, I was hired in
11· · · ··because of my area of expertise in plant pathology.
12· · · ··There's a lot of work using methods to detect the
13· · · ··contaminants which are plant pathogens in the
14· · · ··cannabis product, and a lot of those methods and
15· · · ··almost all of -- well, a majority of them are DNA
16· · · ··based.··And so I have a lot of experience in doing
17· · · ··DNA-based detection of microbes as well as
18· · · ··culture-based, which culture base is you look at
19· · · ··how they grow.··Typically it can be either in a
20· · · ··liquid media, a broth, so like a soup with all the
21· · · ··nutrients that the microbe needs to grow.··And then
22· · · ··you plate that out and you can enumerate those.
23· · · · · · · · ··So it's -- so that's pretty much the
24· · · ··primary methods that are used in the cannabis
25· · · ··regulatory space for detecting bacteria, microbes,

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·1· · · ··fungi.··Mostly our target microbes are the bacteria
·2· · · ··and the fungi.
·3· ·Q· ··When you started in June of 2020 with the CRA did
·4· · · ··you -- is there a training process, or did you go
·5· · · ··through any training to be able to take this
·6· · · ··extensive education and background that you have
·7· · · ··and apply it more to your day-to-day activities?
·8· ·A· ··Yeah, there is about a -- I would say it was
·9· · · ··about -- at the time we were just going remote so
10· · · ··it was about a two-month process, six to eight
11· · · ··weeks of just kind of onboarding.··But also I just
12· · · ··want to say that, you know, I think -- my belief is
13· · · ··my skill set and as someone who has a PhD or the
14· · · ··expectation is you need to sort of be able to apply
15· · · ··all of your training in a more holistic,
16· · · ··comprehensive way.··And I will say that I think
17· · · ··from my CV I've done a lot of writing, so that has
18· · · ··helped me too.
19· ·Q· ··So you had a two-month onboard process.··What did
20· · · ··that consist of?
21· ·A· ··A lot of it was just, you know, going through our
22· · · ··procedures, reading the rules, shadowing other
23· · · ··employees to see how things are working day to day.
24· · · ··Yeah, mostly, you know, reading, but also kind of
25· · · ··being there on the spot with other employees and my

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·1· · · ··coworkers as they're going through those -- you
·2· · · ··know, the stuff that I would be ultimately
·3· · · ··responsible for after my onboarding was complete.
·4· ·Q· ··And what are some of your job duties?··What do you
·5· · · ··do as an LSS?
·6· ·A· ··So we -- our overarching charge is to oversee the
·7· · · ··labs.··We do a lot of review of method validations,
·8· · · ··and they submit those, so we help onboard labs.··We
·9· · · ··also do investigations.··We also, you know, have
10· · · ··forums where we discuss with some of our licensees
11· · · ··the science of it.··So I participate in those and,
12· · · ··you know, any sort of training sessions that are
13· · · ··required for the job.
14· ·Q· ··And you said you oversee labs.··Do you have a
15· · · ··particular list of labs that you oversee?
16· ·A· ··Yes, I do have a -- I don't know how many I have
17· · · ··now but probably about ten labs that I oversee.
18· ·Q· ··Okay.··And when you say oversee, what does that
19· · · ··entail?
20· ·A· ··Well, that would just -- making sure that they're
21· · · ··within compliance.··We do semi-annual inspections.
22· · · ··When they request licenses we do a prelicensure
23· · · ··inspection.··We do 90-day inspections.··And then we
24· · · ··also -- as we can we do audits.··We also run
25· · · ··interlab events which is basically, you know, a

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·1· · · ··round-robin testing through all the labs.
·2· ·Q· ··And is Viridis Lansing or Viridis North on your
·3· · · ··oversight list?
·4· ·A· ··Viridis is now, yes.
·5· ·Q· ··And how long have they been on your list?
·6· ·A· ··I believe I started becoming responsible for
·7· · · ··individual labs in December of 2020.
·8· ·Q· ··And did you start right off the bat with Viridis?
·9· ·A· ··Yeah -- well, Viridis and others and Viridis North.
10· ·Q· ··So in the beginning you had both?
11· ·A· ··Yeah.
12· ·Q· ··And how long did you have both Viridis
14· ·A· ··I believe since our third LSS was hired, which was
15· · · ··2021.··And I don't remember exactly the date, the
16· · · ··month or anything when that transition occurred.
17· · · ··Possibly late in 2021.··But, again, I don't recall
18· · · ··the date.
19· ·Q· ··That's fine.··So when you -- tell me about, if you
20· · · ··can recall, what happened when you first said,
21· · · ··okay, you're going to be working with Viridis?··Did
22· · · ··you make contact?··Did you introduce yourself?
23· · · ··What was your first involvement with them?
24· ·A· ··I mean, like -- it's been a while.··It's like
25· · · ··almost three years now almost?··So -- but I believe

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·1· · · ··that maybe there was a quarterly training session
·2· · · ··that we had.
·3· · · · · · · · ··That was another thing that we do, we do
·4· · · ··quarterly training sessions which is sort of an
·5· · · ··educational and informational session for the labs.
·6· · · · · · · · ··And then I probably was introduced at
·7· · · ··that quarterly training session as here's the list
·8· · · ··of who's responsible for what.··And then I began to
·9· · · ··sort of with the other LSS would maybe shadow them
10· · · ··on their inspections, and then I would lead other
11· · · ··inspections.··And I think that was, again,
12· · · ··beginning in December of 2020.
13· ·Q· ··Were you involved in the December of 2020
14· · · ··semi-annual inspections that were done for Viridis
15· · · ··locations?
16· ·A· ··Yes, I was.
17· ·Q· ··And can you describe -- tell me just the formatting
18· · · ··of that?··Was it in person?··Was it on site?··What
19· · · ··was it and what did it look like?
20· ·A· ··That was when still we had COVID restrictions, and
21· · · ··that was virtual, a Teams call.
22· ·Q· ··Okay.··And were you -- who was all on this Teams
23· · · ··call from the CRA?··We'll start there.
24· ·A· ··I believe it was me and -- we only had two LSSs at
25· · · ··the time.··Allyson Chirio was the other LSS at that

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·1· · · ··time.
·2· ·Q· ··Okay.··And did you do Viridis North and Viridis
·3· · · ··separately?··Together?··Explain to me that process,
·4· · · ··please.
·5· ·A· ··If I recall we probably did that on the same day,
·6· · · ··and it was like a morning one for one of the labs
·7· · · ··and an afternoon one for the other lab.
·8· ·Q· ··And walk me through what it looks like when you --
·9· · · ··I know you said it was on Teams, so tell me, do you
10· · · ··have a checklist you work from?··Do you -- you
11· · · ··know -- were you taking lead?··Was Dr. Chirio
12· · · ··taking lead?··Walk me through what this looks like.
13· ·A· ··I believe I was taking lead at that time.··Again,
14· · · ··this was, like, the first -- my first inspections
15· · · ··on my own.··I mean leading them, sorry, not on my
16· · · ··own.··But -- and, sorry, what was the second part
17· · · ··of the question?
18· · · · · · · · ··MS. HUYSER:··Oh, we lost the ALJ again.
19· · · · · · · · ··MR. RUSSELL:··Oh, there he is.
20· · · · · · · · ··MR. SCHUMACHER:··There we go.
21· · · · · · · · ··JUDGE GOLDSTEIN:··Yep, I was booted, but
22· · · ··I'm back in.
23· · · · · · · · ··MS. HUYSER:··Did you want me to go back?
24· · · ··I don't -- I can't remember.··I thought I stopped
25· · · ··when I saw you disappear.

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·1· · · · · · · · ··JUDGE GOLDSTEIN:··Go ahead, go back.··I
·2· · · ··did pause the recording.··I know Ms. Duda is
·3· · · ··transcribing too.··Maybe she would appreciate it.
·4· · · ··We'll start again.··Sorry about that.
·5· · · · · · · · ··MS. HUYSER:··That's okay.
·6· ·Q· ··(MS. HUYSER) All right, Dr. Rosenzweig, I think we
·7· · · ··had just talked about how you were doing the
·8· · · ··September 2021 -- or excuse me . . .
·9· · · · · · · · ··(Video conferencing technical issues;
10· · · · · · · · ··off-the-record discussion.)
11· ·Q· ··(MS. HUYSER) All right.··So I'm going to take
12· · · ··another step back, Noah, and hopefully I can get
13· · · ··through this.
14· · · · · · · · ··So we were talking about the December
15· · · ··2020 semi-annual inspection before the State so
16· · · ··rudely kicked us all off, and you indicated that
17· · · ··that was virtual as well?
18· ·A· ··Yeah.··Did you hear me?··Yes.
19· ·Q· ··Yes.··Okay.··And this -- you took the lead but
20· · · ··Dr. Chirio was with you; correct?
22· ·Q· ··Can you walk me through what it looked like,
23· · · ··meaning what's your process?··Did you have
24· · · ··checklists?··What do you do to prepare?··Kind of
25· · · ··start from the beginning of -- and describe the

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·1· · · ··steps that you took.
·2· ·A· ··So, again, it's been some time, and, obviously, I
·3· · · ··might do it a little differently now than I did
·4· · · ··when I first started.··But the lab is provided a
·5· · · ··checklist.··It has our rules and then evidence of
·6· · · ··compliance on there.··And we run through that, and
·7· · · ··typically we'll ask for do you have this document,
·8· · · ··is this documented somewhere, and the lab will show
·9· · · ··us that.··If they don't have it at that time we
10· · · ··would have given them I think ten days to respond
11· · · ··with sort of whatever we found that might have been
12· · · ··deficient.
13· ·Q· ··So when you say that you're looking at documents,
14· · · ··is that all you're really doing is saying do you
15· · · ··have this, do you have that?
16· ·A· ··Well, I think the limitation of the virtual part
17· · · ··was that was where we were at at that time where it
18· · · ··was, okay, you know, do you have something for
19· · · ··process A and where is it, and is whatever in the
20· · · ··rule that's supposed to be in a process is it there
21· · · ··and documented.
22· ·Q· ··And as you were going through the virtual
23· · · ··semi-annual inspections we'll start with talking
24· · · ··about Viridis Lansing or, you know, regular
25· · · ··Viridis.··But did you note any deficiencies or have

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·1· · · ··any concerns with things you observed or were
·2· · · ··provided during the December 2021 semi-annual
·3· · · ··inspection?
·4· ·A· ··I don't remember all the details on that inspection
·5· · · ··report, I did not commit those to memory, but I
·6· · · ··believe that was one of the times where we had
·7· · · ··asked to audit their procedure on potency and noted
·8· · · ··that we couldn't follow based on the approved
·9· · · ··method that we had at the time.··And I believe
10· · · ··there might have been some other small details that
11· · · ··they might not have documented, but I can't recall
12· · · ··all that and my notes on that.··I'd have to see the
13· · · ··report.
14· ·Q· ··Let's walk back through a little bit.
15· · · · · · · · ··You said you were conducting an audit at
16· · · ··the same time.··What does that mean?
17· ·A· ··So what we wanted to do is determine, hey, here's a
18· · · ··procedure that you have, are you following that
19· · · ··procedure appropriately because we've approved that
20· · · ··procedure based on what was provided prior.
21· ·Q· ··So before you come into an audit slash semi-annual
22· · · ··inspection when you combine them do you review what
23· · · ··procedure you're planning on auditing?
24· ·A· ··Yeah, I would have likely looked at that procedure
25· · · ··and reviewed it, maybe not in full detail but, you

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·1· · · ··know, sort of went over it just to see what -- you
·2· · · ··know, what it looked like.··I didn't -- I can't
·3· · · ··remember how detailed I went into it, but looked at
·4· · · ··that to familiarize myself with their process.
·5· ·Q· ··And did you watch them perform the potency testing?
·6· ·A· ··Well, we watched Viridis Lansing's lab manager
·7· · · ··perform that.
·8· ·Q· ··Okay.··And did it comply or comport with the
·9· · · ··potency standard operating procedure that CRA had
10· · · ··on file?
11· ·A· ··At that time it did not look like what we had on
12· · · ··file.
13· ·Q· ··Do you recall what you had on file, what it
14· · · ··required, or what it -- the process had outlined?
15· ·A· ··So I believe that one was -- and I think we're
16· · · ··really talking about how they would prepare the
17· · · ··sample to do the analysis, and the way they had
18· · · ··outlined how they prepared it was more just they
19· · · ··would homogenize the sample.
20· · · · · · · · ··And so basically these machines the best
21· · · ··I can describe them are like a big coffee grinder.
22· · · ··So you would grind all the material, and you would
23· · · ··make sure that, you know, your -- your -- if it's
24· · · ··coffee that the ground is -- is acceptable for
25· · · ··whatever machine you're putting it in.··In this

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·1· · · ··case it's an analytical chemistry machine.··And we
·2· · · ··noted that, one, there wasn't any mention of, you
·3· · · ··know, materials to use in that.··I think we noted
·4· · · ··that the procedure didn't state anything that they
·5· · · ··were using extraction beads or balls, which is
·6· · · ··basically a way to even macerate the tissue, the
·7· · · ··plant tissue even more.··That was not documented I
·8· · · ··believe in the original one.··And so we noted that
·9· · · ··they were using these in that procedure.··So from
10· · · ··just, you know, a kind of 30,000-foot view of it
11· · · ··that was one thing we did note.
12· ·Q· ··And when you noted anything during the audit and
13· · · ··you found that they weren't compliant did that
14· · · ··cause them to fail their semi-annual inspection?
15· ·A· ··We did tell them that -- that -- I believe it was
16· · · ··documented that the procedure wasn't the same as
17· · · ··what we had on file, and we submitted that in a
18· · · ··report, the report back -- the --
19· · · · · · · · ··MR. SCHUMACHER:··I'm sorry, it looks like
20· · · ··we lost Ms. Huyser.
21· · · · · · · · ··Oh, she's back.
22· · · · · · · · ··MS. HUYSER:··Sorry.
23· · · · · · · · ··THE WITNESS:··She's back.
24· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah, any State of
25· · · ··Michigan employee, it might benefit you to get off

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·1· · · ··the VPN because that seems to be very unstable.
·2· · · · · · · · ··MS. HUYSER:··I'm not on the VPN and I'm
·3· · · ··hardwired straight in the office.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Still
·5· · · ··happening.··Okay.
·6· · · · · · · · ··MS. HUYSER:··Yeah, because I thought
·7· · · ··about that this morning when you had said that
·8· · · ··yesterday.··So yeah, I am straight hardwired
·9· · · ··directly to our system.
10· · · · · · · · ··JUDGE GOLDSTEIN:··Hmm.
11· · · · · · · · ··MS. HUYSER:··I apologize.
12· · · · · · · · ··JUDGE GOLDSTEIN:··You know, there's
13· · · ··nothing you can do about that.··So go ahead,
14· · · ··Ms. Huyser.
15· · · · · · · · ··MS. HUYSER:··Okay.··Let's see.··Let me
16· · · ··get back to where we were.
17· ·Q· ··(MS. HUYSER) So I believe where I had left off with
18· · · ··you with the question was if you noticed that there
19· · · ··were discrepancies from the standard operating
20· · · ··procedure with potency did that cause a failure in
21· · · ··the semi-annual inspection.
22· ·A· ··I believe we noted that they were deficient on
23· · · ··that, and then I think at that time we gave them
24· · · ··ten days to respond to address those deficiencies.
25· · · ··And the response back was that the method had not

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·1· · · ··changed, that they were using their approved method
·2· · · ··or something to that effect.··I don't know exactly
·3· · · ··what the details were in that response but . . .
·4· ·Q· ··So was that a passing inspection for Viridis?
·5· ·A· ··We ultimately, because they said that they, you
·6· · · ··know, they provided the documentation, they said
·7· · · ··that they were using that process, that they were
·8· · · ··still using process A, and I'm just using that as a
·9· · · ··descriptor for it, that ultimately they were I
10· · · ··think it's compliant is what the term is that we
11· · · ··use on those inspections.
12· ·Q· ··Okay.··And was it the same for Viridis North when
13· · · ··you did a semi-annual virtually the same day for
14· · · ··them?
15· ·A· ··Yes, I believe so.
16· ·Q· ··Okay.··So tell me a little bit -- you mentioned
17· · · ··that you have the semi-annual inspections.··And
18· · · ··when you were providing your list of
19· · · ··responsibilities or things that you do you had
20· · · ··indicated that you're also involved with
21· · · ··validations of standard operating procedures;
22· · · ··correct?
23· ·A· ··Yeah.
24· ·Q· ··And when do you --
25· ·A· ··Reviewing those.··Sorry.

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·1· ·Q· ··I'm sorry.
·2· ·A· ··Reviewing those.
·3· ·Q· ··Okay.
·4· ·A· ··Reviewing and approving, yeah.
·5· ·Q· ··Okay.··And when you were in the laboratory setting
·6· · · ··prior to coming to the CRA did you ever have to
·7· · · ··have methods validated?
·8· ·A· ··Not specifically validated, so to speak, but as far
·9· · · ··as being certified by the USDA we had to have
10· · · ··specific methods on if we bring in soil how do we
11· · · ··handle that soil or whatever.··And so it's not
12· · · ··that -- it's sort of different in the academic
13· · · ··sense, but you need to have that documented that
14· · · ··this is the procedure on how you bring in this
15· · · ··quarantine material or whatever and how that's
16· · · ··disposed of properly and all that, yep.
17· · · · · · · · ··And we had to do that for -- at least for
18· · · ··our I think it's health and safety at MSU, we'd
19· · · ··have to have all that documented, and we'd have
20· · · ··inspections on how we do proper handling of
21· · · ··chemicals and that.··So . . .
22· ·Q· ··Do you feel that that experience helped you be able
23· · · ··to validate -- or excuse me -- review and approve
24· · · ··SOPs at the CRA?
25· ·A· ··That and also being an editor and some of the -- in

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·1· · · ··the phytopath journals.··So we have to review, you
·2· · · ··know, methods and also the research to basically,
·3· · · ··you know, recommend it for publication.
·4· ·Q· ··So when do you validate an SOP or a standard
·5· · · ··operating procedure?
·6· ·A· ··Can you rephrase the question a bit, Sarah?
·7· ·Q· ··Yeah, absolutely.··Sorry about that, it was
·8· · · ··probably a crappy question on my end.
·9· · · · · · · · ··When would you -- when would a licensee
10· · · ··have to validate a standard operating procedure?
11· ·A· ··They would have to do that to be approved to do
12· · · ··that compliance test.
13· ·Q· ··So they have initial validations?··Is that fair to
14· · · ··say?
15· ·A· ··So they -- so when a lab is onboarding they will
16· · · ··maybe submit an initial validation and that might
17· · · ··be on a specific type of marijuana project --
18· · · ··product or, as we like to refer to them, a matrix.
19· · · ··So is that matrix raw plant material.··Is it a
20· · · ··processed plant material.
21· · · · · · · · ··So they might come in and they might do
22· · · ··just one of those targets.··And then, you know,
23· · · ··when they want to add those it's called a matrix
24· · · ··expansion.··So they would have to, you know, repeat
25· · · ··the experiment that they did to validate and get

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·1· · · ··approval of their method and do it again for some
·2· · · ··other type of matrix, target matrix.
·3· · · · · · · · ··Does that make sense?
·4· ·Q· ··Yes.··So if you were talking about let's say a
·5· · · ··particular matrix, like you said raw plant material
·6· · · ··or flower, do labs just come up with their own
·7· · · ··process, or is there guidance out there for people
·8· · · ··to look to?
·9· ·A· ··There is guidance on how to validate a method, and
10· · · ··that is by the AOAC is what it's called, and that's
11· · · ··the Association of -- it's -- it's changed so many
12· · · ··names, but it's an association or organization of
13· · · ··research chemists I believe?··I don't know exactly
14· · · ··the -- what the acronym does stand for
15· · · ··specifically.
16· ·Q· ··So are there methods -- let's say if we're talking
17· · · ··about the flower matrix and we're talking about
18· · · ··potency, are there methods that in the industry are
19· · · ··known to be approved or validated methods?
20· ·A· ··For potency like -- so AOAC has a specific --
21· · · ··another thing, it's called an OMA, official method
22· · · ··of analysis.··And I don't know if there is one for
23· · · ··cannabis, in cannabis for potency.
24· ·Q· ··So how does a lab know how to create a standard
25· · · ··operating procedure?

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·1· ·A· ··So typically they will have some references.··These
·2· · · ··methods might be -- these references could be
·3· · · ··something that you find in a scientific journal or
·4· · · ··they could also be what are called an application
·5· · · ··note which -- so you buy a specific machine from a
·6· · · ··manufacturer, and they might have done some
·7· · · ··validation on cannabis in house and they have an
·8· · · ··application method, which is kind of instructions
·9· · · ··on how to do that.
10· ·Q· ··And what if they go through the onboarding and they
11· · · ··have a standard operating procedure that's been
12· · · ··approved, that's what they're using, and they
13· · · ··decide they want to change it?··What happens then?
14· ·A· ··Well, typically they will -- you know, we have --
15· · · ··we request that they notify us that they've changed
16· · · ··the method.··And, you know, if it's substantial
17· · · ··changes to that method that may affect the results
18· · · ··we would require a revalidation or a verification
19· · · ··that that does not affect those changes, does
20· · · ··not -- do not affect the results that are coming
21· · · ··out of their tests.
22· ·Q· ··So when you say substantial change that impacts the
23· · · ··results, what does that mean?··Like if I fix a typo
24· · · ··is that considered a substantial change?
25· ·A· ··No, no.··I typically will tell my licensees that,

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·1· · · ··you know, if it's -- you know, you find a comma
·2· · · ··missing I don't see that as a defect, you know, a
·3· · · ··change to how the process is done.
·4· · · · · · · · ··If it's a change in how the process is
·5· · · ··done and how it's performed, then you would need
·6· · · ··some sort of data validation, a verification that
·7· · · ··that has not changed the outcome of the testing.
·8· ·Q· ··So if I introduce a different grinding medium does
·9· · · ··that require a change in an SOP?
10· ·A· ··I would say yes.
11· ·Q· ··If I were to introduce or modify how I homogenize
12· · · ··the sample does that require a change?
13· ·A· ··Yes, those would be different steps.··And it -- it
14· · · ··would be the same if it was you prepare -- say you
15· · · ··prepare cannabis flower different from gummy
16· · · ··infused with cannabis.··It would probably be a
17· · · ··little different on how you prepare that.
18· ·Q· ··So what do you do -- what does the CRA require for
19· · · ··a change in an SOP?
20· ·A· ··We would request, you know, the licensee submit
21· · · ··that and, again, it -- we would tell them, you
22· · · ··know, if -- if they -- if it's a procedural change
23· · · ··then we would require them to revalidate that
24· · · ··method.
25· ·Q· ··And what -- what does revalidate mean?··How do you

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·1· · · ··do that or how would a licensee do that?
·2· ·A· ··So I think you did mention and I didn't really
·3· · · ··explain as well as I probably should have about the
·4· · · ··guidance that they have, that AOAC puts out
·5· · · ··guidance in Appendix K and J, and that goes through
·6· · · ··all the steps that are required in a validation.
·7· · · ··So each one you have to follow that guidance, which
·8· · · ··I believe, you know, that's stated in our rules.
·9· · · · · · · · ··And then you follow that guidance and
10· · · ··then there's what are called -- and the -- and also
11· · · ··the AOAC publishes what are called standard method
12· · · ··performance requirements.··And so the method would
13· · · ··have to basically meet all those -- meet or exceed
14· · · ··those performance requirements.
15· · · · · · · · ··So you would submit a report, and that
16· · · ··might be, you know, the components that are
17· · · ··required is, you know, how accurate and how precise
18· · · ··that method is.··Those are just two components.
19· ·Q· ··And when a licensee feels that they've met all
20· · · ··these standards and they want the CRA to review a
21· · · ··method change is there a particular form or
22· · · ··document or format that the CRA requires that?
23· ·A· ··Maybe make that a little clearer?··I think --
24· ·Q· ··Yeah, absolutely.
25· ·A· ··I'm not sure about your question, Sarah, I'm sorry.

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·1· ·Q· ··That's all right.··I apologize.
·2· · · · · · · · ··So a licensee is going through the
·3· · · ··process of wanting to change an SOP, and they
·4· · · ··believe that they have all of the requisite
·5· · · ··information; right?··They believe that they're in
·6· · · ··conformance with Appendix J or K, that they've met
·7· · · ··all the standard -- the SMPRs.··So if they want the
·8· · · ··CRA to review that change is there a required
·9· · · ··document or format to submit that?
10· ·A· ··So on the licensee side there's no, hey, here's a
11· · · ··doc, they fill this form out and they want to
12· · · ··submit this, what they will do is they typically --
13· · · ··they'll send us an email to the -- our general docs
14· · · ··and send all the required documents that we use to
15· · · ··review those to assess that method and to approve
16· · · ··that method.
17· · · · · · · · ··Does that make sense?··Does that answer
18· · · ··your question, Sarah?
19· ·Q· ··It does.··Thank you.
20· · · · · · · · ··And when the CRA receives this email
21· · · ··containing -- saying, hey, can you look at our --
22· · · ··review our SOP what does the CRA do from there?
23· ·A· ··So what we typically do is we will -- first we will
24· · · ··review what they've submitted and make sure that
25· · · ··all of the required documentation is submitted to

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·1· · · ··us so that we are able to review that method.··And
·2· · · ··that can be all the data that comes off the machine
·3· · · ··that records that data and how they would, you
·4· · · ··know, use that data to calculate the performance
·5· · · ··criteria, including accuracy and precision.
·6· ·Q· ··And when it comes time to deny or approve a change
·7· · · ··in method what happens at that stage?
·8· ·A· ··So first if they -- if they submit their method for
·9· · · ··review, and typically they will say, you know,
10· · · ··we're submitting X, Y, and Z or X for review and
11· · · ··approval, if there's anything that they did not
12· · · ··include which, you know, we have a checklist, we
13· · · ··will send that back to them.··If not we will review
14· · · ··that and then we will issue them a Method
15· · · ··Validation Review and also will document that on
16· · · ··a -- their method summary report.
17· · · · · · · · ··So that's -- so one document is used to
18· · · ··basically, you know, our rubric on all the
19· · · ··components that we need to assess that process,
20· · · ··that procedure.
21· · · · · · · · ··And then the other one is just -- has
22· · · ··some of that information but mostly just the
23· · · ··general overview on either -- you know, the easiest
24· · · ··is they've done everything and it's been approved,
25· · · ··we'll say it meets all our rules and our

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·1· · · ··requirements in our guidance, and -- or if there is
·2· · · ··something missing we will document that in the
·3· · · ··auditor's notes or in one of the -- you know, the
·4· · · ··different criteria that we use to review that.
·5· · · · · · · · ··And, again, those notes will probably be
·6· · · ··at least -- it's customary for what I do is I will
·7· · · ··put those in -- both in that method validation
·8· · · ··review, the method summary report as well as in the
·9· · · ··body of the email when I respond to that licensee.
10· ·Q· ··So can you get a method approved at a semi-annual
11· · · ··inspection?
12· ·A· ··No.
13· ·Q· ··Can you get a method approved in -- during an
14· · · ··audit?
15· ·A· ··No.··I mean, I guess that's sort of a trick
16· · · ··question.··I mean, in the absence of -- if it's
17· · · ··just, hey, I'm going to watch this, no, you cannot.
18· ·Q· ··If you pass a semi-annual inspection does that mean
19· · · ··that any changes that you made to your process are
20· · · ··approved?
21· ·A· ··I don't believe so, no.
22· ·Q· ··Okay.··So at some point in time did you learn that
23· · · ··there were issues with the potency methods or
24· · · ··potency results from Viridis, from either Viridis
25· · · ··locations?

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·1· ·A· ··That question again, Sarah?
·2· ·Q· ··Yep.··Sorry.
·3· · · · · · · · ··Did you -- so when you -- you performed
·4· · · ··your December 2020 semi-annual inspection.··When
·5· · · ··you went in there were you aware that -- did you
·6· · · ··have concerns about Viridis's potency, either their
·7· · · ··method or the results that they were providing?
·8· ·A· ··Did I directly know about that?··At that time I
·9· · · ··don't think I was sort of aware of all the parts
10· · · ··and pieces that were going on at the time.··But,
11· · · ··you know, I was told to -- again, this is sort of
12· · · ··really early in my process here -- was to observe
13· · · ··this, that, you know, there may be some concerns.
14· ·Q· ··Okay.
15· ·A· ··But as far as what those details were, at that time
16· · · ··I did not know those.
17· ·Q· ··So you went in and you observed what was going on
18· · · ··to find out what was going on; is that fair to say?
19· ·A· ··Yes, sort of to audit that process to compare what
20· · · ··we had on file with what they were doing.
21· ·Q· ··Give me one second, here.··Sorry, bear with me one
22· · · ··moment here.
23· · · · · · · · ··And after you and Dr. Chirio were there
24· · · ··you said that you mentioned that you did reports
25· · · ··after the semi-annual inspection and after the

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·1· · · ··audit.··And do you remember looking at grinding
·2· · · ··media and looking at how many grinding medias were
·3· · · ··included for different types of tests?
·4· · · · · · · · ··If that's a really horrible question I
·5· · · ··apologize.··I can share my screen, it might be
·6· · · ··easier.
·7· ·A· ··Yeah, you may need to repeat that.
·8· ·Q· ··That's okay.
·9· ·A· ··I'm not entirely clear what you're asking.
10· ·Q· ··All right.··Do you recognize the document that is
11· · · ··on the screen right now?
12· ·A· ··I see my name's on that but I don't remember this
13· · · ··particular piece.
14· ·Q· ··Okay.
15· ·A· ··What's the date on that?
16· ·Q· ··The date on it is January 4th of 2021.
17· ·A· ··Oh, that's the attachment?
18· ·Q· ··Yes.
19· ·A· ··Yeah, I believe I remember this part.··I don't
20· · · ··remember seeing this exact table though.
21· ·Q· ··Okay.··Do you remember at -- during your
22· · · ··semi-annual inspection looking to see the number of
23· · · ··grinding media that were included or used?
24· ·A· ··Well, I will say this, that at the time the
25· · · ··procedure, SOP that was approved on file, again, I

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·1· · · ··don't recall that noting any of these specific --
·2· · · ··the grinding balls in there.··And then when we
·3· · · ··observed it we did notice that in the
·4· · · ··homogenization process.
·5· ·Q· ··And were there a consistent number of grinding
·6· · · ··media being used for every type of client?
·7· ·A· ··I -- I don't have the information -- I can't
·8· · · ··comment on that.
·9· ·Q· ··Okay.··I'm going to stop sharing my screen at this
10· · · ··point.
11· · · · · · · · ··So were you ever after the September --
12· · · · · · · · ··MR. SCHUMACHER:··Sarah, I'm sorry to
13· · · ··interrupt.··Were you admitting that or was
14· · · ··that . . .
15· · · · · · · · ··MS. HUYSER:··No.··If he indicated he
16· · · ··didn't recognize the table --
17· · · · · · · · ··MR. SCHUMACHER:··Okay.
18· · · · · · · · ··MS. HUYSER:··-- I wasn't going to move
19· · · ··through admission with him.··I'll admit it through
20· · · ··another witness.
21· · · · · · · · ··MR. SCHUMACHER:··Okay, I just wanted to
22· · · ··make sure I didn't miss it.··Thank you.··Sorry to
23· · · ··interrupt.
24· · · · · · · · ··MS. HUYSER:··That's okay.
25· ·Q· ··(MS. HUYSER) All right.··So excuse me.··Let me get

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·1· · · ··back to where that was.
·2· · · · · · · · ··All right, Noah, at this point in time
·3· · · ··after the December 2020 semi-annual inspection did
·4· · · ··you learn of any requests or changes in the
·5· · · ··standard operating procedure for potency or did you
·6· · · ··review -- I don't want to say review -- did you
·7· · · ··learn that there was a proposed change?
·8· ·A· ··Did you say post the inspection?
·9· ·Q· ··Yes, after your semi-annual.··Because you said when
10· · · ··you went in you didn't know -- you said in December
11· · · ··when you went in you weren't aware that there were
12· · · ··issues or things that you had to be concerned with.
13· · · ··Did you ultimately learn that there were concerns?
14· ·A· ··Yes, ultimately I did, yeah.
15· ·Q· ··And do you recall when that happened?
16· ·A· ··You know, I can't recall, but the date, you know,
17· · · ··sort of that was late in December, so maybe after
18· · · ··the first of the year or after -- you know, no, I
19· · · ··don't recall the exact dates or anything.
20· ·Q· ··And even if we're not talking an exact date was it
21· · · ··relatively close to your semi-annual or was it
22· · · ··months later?··If you had to go through your memory
23· · · ··and think about it what are you thinking?
24· ·A· ··It was probably, you know, within the next month or
25· · · ··so of -- after the inspection.··Obviously I would

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·1· · · ··have -- you know, we would have discussed that with
·2· · · ··our manager and said that we observed this change.
·3· · · ··And then I -- if there was communication between
·4· · · ··Viridis and the CRA prior to that then maybe I
·5· · · ··would have been informed on that.
·6· ·Q· ··Okay.··So at this point did you do anything between
·7· · · ··the December 2020 semi-annual inspection and the
·8· · · ··June 2021 semi-annual inspection?
·9· ·A· ··Did I do anything?
10· ·Q· ··Meaning were you -- did you have any additional
11· · · ··audits?··Did you create any reports?··Anything
12· · · ··along those lines.··Were you involved in any other
13· · · ··steps with Viridis?
14· ·A· ··Well, I believe we would have probably had an
15· · · ··investigation on that, and I think I did write in
16· · · ··the investigation that they were not following
17· · · ··their approved method.
18· · · · · · · · ··And then I think subsequent to that, and
19· · · ··I can't remember -- it was probably prior to that
20· · · ··inspection we went on site, and at that time we
21· · · ··asked all of our licensees to demo their sample
22· · · ··prep for potency.··So I believe that's what we did
23· · · ··for everyone during their inspections and including
24· · · ··Viridis and Viridis North.
25· ·Q· ··And was that during the June 2021 semi-annual

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·1· · · ··inspection that you reviewed a demo?
·2· ·A· ··Yes.
·3· ·Q· ··Can you hear me?··Okay.··Sorry, I wasn't sure if it
·4· · · ··hesitated.
·5· ·A· ··I can hear you.··We can hear you --
·6· · · · · · · · ··JUDGE GOLDSTEIN:··You appear to be
·7· · · ··frozen --
·8· · · · · · · · ··THE WITNESS:··-- but you're frozen.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··-- but we hear you.
10· ·Q· ··(MS. HUYSER) Okay.··Hopefully it catches up at some
11· · · ··point.··Goodness.
12· · · · · · · · ··Okay.··So at this point in time I'm going
13· · · ··to share my screen again.··You mentioned that you
14· · · ··authored a report after your December 2020
15· · · ··semi-annual inspection?
17· ·Q· ··Okay.··And why did you go -- why was there an
18· · · ··investigation, and why did you author a report?
19· ·A· ··Well, I think at -- one of the reasons that -- can
20· · · ··you still hear me?
21· ·Q· ··I can.
22· ·A· ··One of the reasons was not adhering to their
23· · · ··approved SOP, but also we started to -- we had been
24· · · ··doing potency audits for any -- for any and all
25· · · ··labs that report back a certain potency that was

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·1· · · ··over a threshold.··And so we started to get a lot
·2· · · ··of results coming out of Viridis that were a bit --
·3· · · ··that weren't the same as what they had been
·4· · · ··reporting.··So there had been a lot of those high
·5· · · ··potency audits that were performed.
·6· ·Q· ··And what is the threshold for a requirement for a
·7· · · ··high potency audit?
·8· ·A· ··29 percent.
·9· ·Q· ··And can you tell me where that number comes from?
10· ·A· ··Well, there's a lot of -- there's -- there is a
11· · · ··couple publications out there looking at the
12· · · ··potency and, you know, the -- in cannabis and the
13· · · ··regulated market, and I believe that the
14· · · ··percentile, the 99th percentile, which is one out
15· · · ··of 100, is -- that threshold is 27 percent.··So
16· · · ··assuming that there is some -- a little bit of
17· · · ··variability in, you know, and accuracy of plus and
18· · · ··minus of a threshold that that was stated in our
19· · · ··procedure that I had been following.
20· ·Q· ··So if there is a lab test that's reported to Metrc
21· · · ··or that is above 29 percent what happens?
22· ·A· ··Then that lab will be contacted, and we will ask
23· · · ··that lab to reprocess that sample and test it again
24· · · ··to confirm those results.
25· ·Q· ··And is there a requirement that they come within a

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·1· · · ··certain range if they reproduce the results?
·2· ·A· ··Yeah.··So if -- I believe it's a difference of 15
·3· · · ··percent.··If it's above that that typically is
·4· · · ··outside of the range of what their method
·5· · · ··performance criterias are.··So we would ask them to
·6· · · ··do -- you know, do an audit of that to find out why
·7· · · ··it's above that threshold that they stated their
·8· · · ··method adheres to, and they would have to determine
·9· · · ··why that was.
10· · · · · · · · ··And after that they would -- if they can
11· · · ··find the reason for that they would do a corrective
12· · · ··action and a preventative action.··So that would
13· · · ··just document what they did and how they corrected
14· · · ··it and how they would do that -- how they would
15· · · ··prevent that in the future.
16· ·Q· ··And this policy, does it apply only to Viridis?
17· ·A· ··No.
18· ·Q· ··So any laboratory that was over the threshold?
19· ·A· ··Yep.··And just to add one thing, it's also 29
20· · · ··percent in -- of cannabis flower, but in the
21· · · ··processed concentrate it's a 90 percent threshold.
22· ·Q· ··So --
23· ·A· ··But all those -- all those -- excuse me.··I'm
24· · · ··sorry.
25· ·Q· ··No, go ahead, please.

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·1· ·A· ··So any results that come in that have those
·2· · · ··results, that threshold and above, will get audited
·3· · · ··no matter where they're tested.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··I'm sorry to interject
·5· · · ··but you mentioned something about a 90 percent.··I
·6· · · ··may have missed it.··Is that a different product?
·7· · · · · · · · ··THE WITNESS:··Yeah, that's -- I just
·8· · · ··wanted to couch that, Your Honor, that we have a
·9· · · ··threshold for flower --
10· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.
11· · · · · · · · ··THE WITNESS:··-- and then a threshold for
12· · · ··a concentrated product.
13· · · · · · · · ··JUDGE GOLDSTEIN:··Oh, concentrated THC
14· · · ··you mean?
15· · · · · · · · ··THE WITNESS:··Yeah.··So the plant is
16· · · ··processed into basically an extracted -- extract
17· · · ··everything out of the plant except for a lot of the
18· · · ··plant material and that's a concentrate.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Thank you.
20· ·Q· ··(MS. HUYSER) And the concerns with Viridis's
21· · · ··potency, just to be clear, that related to flower;
22· · · ··correct?
23· ·A· ··Yes.
24· ·Q· ··Okay.··So their potency levels, that was on the
25· · · ··flower matrix, and that was the 29 percent?

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·1· ·A· ··Correct.
·2· ·Q· ··Okay.··I just want to make sure I'm following
·3· · · ··through.
·4· · · · · · · · ··MR. SCHUMACHER:··Would we be able to take
·5· · · ··a break?··I don't want to interrupt your flow, but
·6· · · ··before you get into the exhibit could we take a
·7· · · ··break?
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah, I was going to
·9· · · ··suggest that.··It's 10:15 already.··We'll take a
10· · · ··break till 10:35.··Okay?
11· · · · · · · · ··MR. SCHUMACHER:··Thank you.
12· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··We're off
13· · · ··the record at 10:15.··Thank you.
16· · · · · · · · ··(Break taken at 10:15 AM)
17· · · · · · · · ··(Break concluded at 10:42 AM)
18· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··We're back
20· · · ··Laboratories, LLC, and Viridis North versus
22· · · ··Numbers 21-029794, et al.··The time is 10:42 AM.
23· · · · · · · · ··And, Counsel, you may proceed.
25· ·Q· ··(MS. HUYSER) Okay, Dr. Rosenzweig, can you see what

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·1· · · ··is being shared on my screen?
·2· ·A· ··Yes, I can.
·3· ·Q· ··Okay.··I'm going to have you take a look at it
·4· · · ··slowly.··I'll scroll through at least the first
·5· · · ··couple pages at this point just so you can
·6· · · ··acclimate yourself.
·7· · · · · · · · ··And do you recognize what this document
·8· · · ··is?
·9· ·A· ··Yeah --
10· ·Q· ··And can you tell --
11· ·A· ··-- I can.
12· ·Q· ··Oops.··Sorry.
13· · · · · · · · ··Can you tell me what it is, please?
14· ·A· ··It's an investigation report.
15· ·Q· ··And when was this investigation report drafted?
16· ·A· ··It looks like 3/10/21.
17· ·Q· ··Okay.
18· ·A· ··That was when it was completed but --
19· ·Q· ··And --
20· ·A· ··So . . .
21· ·Q· ··Sorry.··Go ahead.
22· ·A· ··Pardon me.··Sorry, Counsel.
23· · · · · · · · ··Yeah, I mean -- yeah, it was completed,
24· · · ··so it might have been started -- the draft might
25· · · ··have been started prior to that date, but that was

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·1· · · ··I believe when I had submitted it to my manager --
·2· · · ··or nor not my manager but at the time the manager
·3· · · ··who was responsible for reviewing those on 3/10.
·4· ·Q· ··And at that point in time the manager who was doing
·5· · · ··your reviews was Donald Christy; correct?
·6· ·A· ··Yeah --
·7· ·Q· ··And --
·8· ·A· ··-- that's correct.
·9· ·Q· ··Who is your current manager?
10· ·A· ··My current manager is Claire Patterson.
11· ·Q· ··Okay.··I'm going to briefly go through.··I want to
12· · · ··make sure that there hasn't been any changes or
13· · · ··alterations to this -- did we lose -- okay.··There
14· · · ··hasn't been any changes or alterations to this
15· · · ··document since the form that it was provided to us.
16· · · · · · · · ··As we get to the bottom here does this
17· · · ··document, is it a full and accurate representation
18· · · ··of your report that was dated March of 2021?
19· ·A· ··Yes, it is.
20· ·Q· ··Okay.··Any changes or alterations?
21· ·A· ··I don't believe so.
22· · · · · · · · ··MS. HUYSER:··At this point in time, Your
23· · · ··Honor, I would ask that CRA proposed Exhibit 19 be

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·1· · · · · · · · ··MR. SCHUMACHER:··No objection, Your
·2· · · ··Honor.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··CRA Exhibit
·4· · · ··19 is admitted.
·6· · · · · · · · ··(CRA Exhibit 19 is admitted.)
·7· ·Q· ··(MS. HUYSER) Can you tell me, Noah, a little bit
·8· · · ··about why you drafted this report?
·9· ·A· ··I believe I drafted this report of noncompliance of
10· · · ··using an approved method.
11· ·Q· ··Was it based on --
12· ·A· ··Sorry.··Using a nonapproved method.
13· ·Q· ··And did you determine that based on observations
14· · · ··that were made at the semi-annual inspection?
15· ·A· ··Yes, I did.
16· ·Q· ··And at this point in time were there any -- were
17· · · ··there complaints that the CRA was receiving or that
18· · · ··you were investigating regarding potency levels at
19· · · ··Viridis Laboratories?
20· ·A· ··I can't say that I would know definitively at that
21· · · ··time if we -- you know, when those complaints came
22· · · ··in.··So if it states somewhere in there that there
23· · · ··was a complaint outside of the Agency, but I don't
24· · · ··think this has that.··So . . .
25· ·Q· ··Okay.··But you are aware that there were complaints

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·1· · · ··that were coming in; correct?
·2· ·A· ··Yes.··Again, I don't know if it was prior to this
·3· · · ··or during this or -- or, you know, if it happened
·4· · · ··as I was writing this.··I don't know the exact
·5· · · ··timeline.··And, as I said, it's been almost two
·6· · · ··years.··So . . .
·7· ·Q· ··And I just want to go over just for the sake of
·8· · · ··purposes of clarity a couple names that are in
·9· · · ··here.··Okay?
10· · · · · · · · ··We see the name of Michael LaFramboise.
11· · · ··Can you tell me who he is?
12· ·A· ··He's the laboratory manager at Viridis North.
13· ·Q· ··And that's the Bay City location; correct?
15· ·Q· ··And did you observe him performing potency tests?
16· ·A· ··Yes, I did.
17· ·Q· ··And were they in accordance with the approved SOP?
18· ·A· ··They were not.
19· ·Q· ··And when did you observe him performing those
20· · · ··tests?
21· ·A· ··At that -- during the potency prep audit at the
22· · · ··semi-annual.
23· ·Q· ··At the December semi-annual?
24· ·A· ··Yes, that's correct.··It probably states that on
25· · · ··above, did it not?··The opening line?··Or

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·1· · · ··somewhere?··Yeah, on 12/20?··22?··20?
·2· ·Q· ··All right.··I'm going to stop sharing my screen at
·3· · · ··this point in time.··Yeah, thank you.
·4· · · · · · · · ··So the next time that you did a
·5· · · ··semi-annual inspection we talked about briefly was
·6· · · ··in June of 2021; correct?
·7· ·A· ··That's correct.
·8· ·Q· ··And was this routine as far as this is the next
·9· · · ··time that it was set for, it was scheduled to do as
10· · · ··normal course of business?
11· ·A· ··Yes, that's correct, Counselor.··Yep.
12· ·Q· ··Okay.··And was this on site?··Virtual?··What did it
13· · · ··look like?
14· ·A· ··The June?
15· ·Q· ··Yes, sir.
16· ·A· ··I believe the June was a virtual inspection, but we
17· · · ··went on site to perform the -- what was the prep
18· · · ··audit for -- for this inspection.
19· ·Q· ··Okay.··So this -- just to make sure I'm
20· · · ··understanding, I want to make sure I'm
21· · · ··understanding it correctly, this June semi-annual
22· · · ··inspection you did a potency audit once again?
23· ·A· ··I don't know exactly if it was concurrent to the
24· · · ··inspection where we did the inspection and we did
25· · · ··the audit of the prep or was it we did an

(517) 388-3128
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·1· · · ··inspection and maybe we came the next day to do an
·2· · · ··audit prep.··The audit of the sample prep.
·3· ·Q· ··But they were both done in conjunction; is that
·4· · · ··fair to say?
·5· ·A· ··Yes.··I don't know -- as I said, I don't know if it
·6· · · ··happened that same day, but it was in short order
·7· · · ··that we had the inspection and then we went on site
·8· · · ··to do the observation of it.
·9· · · · · · · · ··MS. HUYSER:··Your Honor, I'm sorry, I saw
10· · · ··you flip in and out.··Is everything okay, or would
11· · · ··you like me to stop?
12· · · · · · · · ··JUDGE GOLDSTEIN:··No, keep going.··I keep
13· · · ··flipping in and out.··Ms. Duda as I'm certain has
14· · · ··transcribed it so she heard whatever was discussed.
15· · · ··I'm not going to continue to have you repeat
16· · · ··everything.
17· · · · · · · · ··I don't know what's going on on my end,
18· · · ··it just continues to go in and out, so . . .
19· · · · · · · · ··MS. HUYSER:··Okay.··I just wanted to --
20· · · ··yeah, I understand it's being transcribed, I just
21· · · ··wanted to make sure that you, just in case there's
22· · · ··any evidentiary issues or anything comes up that
23· · · ··you were comfortable with me going forward.
24· · · · · · · · ··JUDGE GOLDSTEIN:··Well, as long as I keep
25· · · ··going in and then -- or out and then coming right

(517) 388-3128
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·1· · · ··back in.
·3· ·Q· ··(MS. HUYSER) So, Doctor -- and you did mention, I
·4· · · ··just want to make sure I understood, that it was on
·5· · · ··site.··So this is one of the first ones that
·6· · · ··probably were done after COVID restrictions --
·7· · · · · · · · ··MR. RUSSELL:··Sarah, I think he's frozen
·8· · · ··again.··Sorry.··Maybe the judge is frozen.
·9· · · · · · · · ··MS. HUYSER:··Okay.··Thanks.··I didn't
10· · · ··notice.
11· · · · · · · · ··MR. RUSSELL:··Sorry, I didn't mean to
12· · · ··interrupt you, but at least on my screen he is.
13· · · · · · · · ··MS. HUYSER:··Yeah, I'm glad you said
14· · · ··something because I didn't notice.··I'm trying to
15· · · ··catch it.
16· · · · · · · · ··(Video conferencing technical issues; off
17· · · · · · · · ··the record from 10:51 AM to 11:03 AM)
19· · · ··the matter of Viridis Laboratories, LLC, and
20· · · ··Viridis North versus Cannabis Regulatory Agency,
21· · · ··consolidated Docket Numbers 21-029794, et al.
22· · · · · · · · ··All right, Ms. Huyser, I'm sorry to
23· · · ··continue to interrupt your questioning here.··You
24· · · ··may continue.
25· · · · · · · · ··MS. HUYSER:··That's okay.··Thank you.

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·1· ·Q· ··(MS. HUYSER) So you were -- I'm trying to remember
·2· · · ··where exactly I left off too now.
·3· · · · · · · · ··Dr. Rosenzweig, you were present for --
·4· · · ··we were talking about a June 2021 semi-annual
·5· · · ··inspection; correct?
·7· ·Q· ··And you said that there was an audit that was done
·8· · · ··simultaneous -- not simultaneously but that they
·9· · · ··were done in junction with one another?
10· ·A· ··That's correct.··Yep.
11· ·Q· ··And that was on site?
12· ·A· ··Yeah, the audit was on site.
13· ·Q· ··So, again, when you walk into the June 2021
14· · · ··semi-annual inspection was that virtually or was
15· · · ··that on site as well?
16· ·A· ··The question?··Sarah?··Can you hear me?
17· ·Q· ··I can hear you.··Can you hear me okay?
18· ·A· ··Yeah.··Can you repeat the question?
19· ·Q· ··Yeah, sorry, I didn't hear that portion.
20· · · · · · · · ··Was the semi-annual inspection on site or
21· · · ··virtual?
22· ·A· ··So the inspection piece I believe was virtual.··It
23· · · ··was -- I think this was a hybrid.··It was virtual
24· · · ··and then the audit of the procedure was on site.
25· ·Q· ··So let's talk about the semi-annual

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·1· · · ··inspection . . .
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Go ahead, Counsel.
·3· ·Q· ··(MS. HUYSER) Let's talk about the semi-annual
·4· · · ··inspection portion of it first.··Okay?
·5· · · · · · · · ··I'm sorry, just -- I just probably should
·6· · · ··have said this earlier.··With Ms. Duda transcribing
·7· · · ··we have to use the yes and no because she can't
·8· · · ··transcribe anything that's not verbal.
·9· ·A· ··Got it.
10· ·Q· ··Thank you.··I'm used to court reporters yelling at
11· · · ··me if I let my witness go by, so I'll stop and
12· · · ··correct you real quick.
13· · · · · · · · ··So at this point when you did the
14· · · ··semi-annual what did you do to prepare for this
15· · · ··June semi-annual inspection?
16· ·A· ··I possibly would have reviewed the previous
17· · · ··inspection and any documentation that was provided
18· · · ··for that.··And then possibly, although I don't know
19· · · ··if I had been doing it at that time, would just
20· · · ··remind the licensee prior to the inspection to fill
21· · · ··out our check list as the best that they can so we
22· · · ··can have that work along while we do the
23· · · ··inspection.
24· ·Q· ··So you send them a checklist to fill out ahead of
25· · · ··time?

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·1· ·A· ··I don't know if I had sent it, but it is available
·2· · · ··on our centralized website for the licensees to
·3· · · ··download.
·4· ·Q· ··Okay.··And is that kind of a template of what you
·5· · · ··follow to help guide you through the semi-annual
·6· · · ··inspection?
·7· ·A· ··Yes, that's correct.
·8· ·Q· ··And as you walk through -- so tell me what you did
·9· · · ··with this semi-annual inspection.
10· ·A· ··So, similarly, there would be a rule stated and
11· · · ··then the item, I think it's item notes or
12· · · ··something, and then evidence of compliance.··And we
13· · · ··might say, you know, what we are looking for to see
14· · · ··there's evidence of compliance.
15· · · · · · · · ··Let's gave an example.··Their sampling,
16· · · ··you're required to take 0.5 percent of the batch.
17· · · ··Is that -- 0.5 of the batch of marijuana that
18· · · ··you're sampling, and is that in their procedure.
19· · · ··Is that documented as evidence of compliance.
20· · · ··That's just one example.
21· ·Q· ··So you make sure they have everything on file, is
22· · · ··that fair to say, that they're not missing any
23· · · ··SOPs?
24· ·A· ··Yes.··Yes.
25· ·Q· ··And then you ask questions if you have questions

(517) 388-3128
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·1· · · ··about them.
·2· · · · · · · · ··Do you watch them perform anything?
·3· ·A· ··As far as the inspection part, the pure inspection
·4· · · ··part, no, we do not.··We don't audit everything
·5· · · ··during an inspection, otherwise the inspection
·6· · · ··would probably go on for days.
·7· ·Q· ··So . . .
·8· · · · · · · · ··MS. HUYSER:··I'm just stopping because
·9· · · ··I'm not sure if the ALJ can hear or not.
10· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah, I'm back.
11· · · ··Continue.··Thank God we have Ms. Duda.··Continue
12· · · ··with your questioning.··For the transcript.
13· · · · · · · · ··Go ahead, Counsel.··I just sent to my
14· · · ··tech department for assistance.
15· · · · · · · · ··MS. HUYSER:··Okay.··And again, Your
16· · · ··Honor, I'm not trying to be difficult, I'm just
17· · · ··trying to make sure that, like I said, even though
18· · · ··Ms. Duda is transcribing, with you presiding over
19· · · ··these proceedings just to make sure that if there
20· · · ··is some type of evidentiary issue or recollection
21· · · ··issue that comes up later something that you can
22· · · ··rule on.··So that's the only reason I'm stopping.
23· · · · · · · · ··JUDGE GOLDSTEIN:··I know.··I understand.
24· · · ··And even that, when you're coming through your
25· · · ··voice is garbled.··So there's clearly something

(517) 388-3128
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·1· · · ··going on.··And I'm not certain -- my internet
·2· · · ··connection is fine.··So I don't know what's
·3· · · ··happening.
·4· · · · · · · · ··MS. HUYSER:··Okay.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··So hopefully I'll have
·6· · · ··some assistance for you.
·7· · · · · · · · ··Go ahead, Counsel.
·8· · · · · · · · ··MS. HUYSER:··Okay.··Thank you.
·9· ·Q· ··(MS. HUYSER) So, Dr. Rosenzweig, sorry.··Stepping
10· · · ··back into where I was.
11· · · · · · · · ··When you were going through you said it
12· · · ··would take days if you audited everything.··So as
13· · · ··you walked through this semi-annual inspection,
14· · · ··just that piece of it, did you find any
15· · · ··deficiencies or have anything of concern as you
16· · · ··were going through with Viridis, either Viridis
17· · · ··laboratory?
18· ·A· ··I -- well, I just want to make it clear that at
19· · · ··that time I was only responsible for Viridis.··So I
20· · · ··did not conduct only the inspection in Viridis
21· · · ··North.··So this would just be for Viridis in the
22· · · ··June.
23· · · · · · · · ··And then I -- I can't recall from memory
24· · · ··exactly what was documented in that inspection
25· · · ··report.··I would have to see it.··But I do feel

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·1· · · ··like at that time there probably was some
·2· · · ··deficiencies, and they had an opportunity to
·3· · · ··respond to that within the ten days.··But, again, I
·4· · · ··would have to see that inspection report to know
·5· · · ··exactly what I noted.
·6· ·Q· ··Are you able to see what's being shared on my
·7· · · ··screen?··And if you need me to make it any bigger
·8· · · ··please let me know as well.
·9· ·A· ··I think I'm good, yes.
10· ·Q· ··Okay.··And do you recognize, if I go slowly through
11· · · ··what this is, do you recognize it?
12· ·A· ··Yeah.··Yes, I do.
13· ·Q· ··And what do you recognize it to be?
14· ·A· ··That's an investigation report.
15· ·Q· ··Okay.··And --
16· ·A· ··But, yeah, I believe that I have that noted.··This
17· · · ··is an attachment to the investigation report.··So
18· · · ··the attachment is actually the inspection report,
19· · · ··Attachment 8.
20· ·Q· ··And is this the inspection report that you're
21· · · ··referring to that you would need to look through to
22· · · ··determine if there has been any deficiencies noted
23· · · ··from the June of 2021 semi-annual inspection?
24· ·A· ··Yes.··And I believe at the top that it does say
25· · · ··deficiencies are noted below.··Right there in that

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·1· · · ··paragraph under the table.
·2· ·Q· ··Okay.··Right in this paragraph?··Okay.
·3· · · · · · · · ··I'm going to briefly scroll through this
·4· · · ··because, again, I just want to make sure that you
·5· · · ··identify this as the inspection report.··And please
·6· · · ··tell me if there are any concerns or changes from
·7· · · ··the way that you have created the report.
·8· ·A· ··Can I comment now?
·9· ·Q· ··Yes, please.
10· ·A· ··The only changes were the highlighted which might
11· · · ··have been documented in the body of this
12· · · ··investigation report and I might have referenced
13· · · ··it.··These are these points in -- that have been
14· · · ··highlighted.··But that's the only changes.··No
15· · · ··change in the text.
16· ·Q· ··No change in the content.
17· · · · · · · · ··So this is an accurate Attachment 8 that
18· · · ··indicates that it's the inspection report from June
19· · · ··7th of 2021 is an accurate depiction of your
20· · · ··inspection report that you generated; correct?
21· ·A· ··That's correct, yes.
22· ·Q· ··And this is a full -- this is the full version;
23· · · ··correct?

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·1· · · · · · · · ··At this time I would ask that CRA
·2· · · ··proposed Exhibit 15 be admitted.
·4· · · ··Honor.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··CRA Exhibit 15 is
·8· · · · · · · · ··JUDGE GOLDSTEIN:··You're welcome.
10· ·Q· ··(MS. HUYSER) Doctor, you stated it does state that
11· · · ··there were deficiencies that were noted.··What
12· · · ··types of deficiencies?··And if you need me to
13· · · ··scroll down so you can direct our attention to them
14· · · ··please let me know.
15· ·A· ··I believe anything that is output onto this is
16· · · ··where there's deficiencies noted.
17· · · · · · · · ··And then, yeah, I see that I've added
18· · · ··that -- and I've added that this particular
19· · · ··procedure was not followed according to the
20· · · ··approved procedure that we had on file.
21· ·Q· ··Okay.··And what procedure are we talking about?
22· ·A· ··That is the 71A that was approved on 5/18 of 2020.
23· ·Q· ··And what type of testing does that pertain to?
24· ·A· ··That's for potency analysis.
25· ·Q· ··Okay.··So can you break that down to me what that

(517) 388-3128
Page 713
·1· · · ··means?··Translate it for me.
·2· ·A· ··Will you rephrase that question, please, Counselor?
·3· ·Q· ··Absolutely.··So you indicated that this -- that
·4· · · ··there was a number associated with an SOP that was
·5· · · ··not being followed and that was the deficiency that
·6· · · ··you -- that you found; correct?
·7· ·A· ··Yes.
·8· ·Q· ··Okay.··So tell me what -- what -- what led you to
·9· · · ··believe that this was -- that the SOP was not being
10· · · ··followed?··What did you observe?
11· ·A· ··I believe this was when we audited them to perform
12· · · ··that approved procedure.··The procedure that we had
13· · · ··approved on file.
14· ·Q· ··Okay.··And what was the procedure that was approved
15· · · ··on file?
16· ·A· ··The name?··The type?··What is -- can you clarify
17· · · ··that question, please?
18· ·Q· ··Sure.··What was the approved potency method for
19· · · ··flower on file?··A name, a date, the process,
20· · · ··whichever is the easiest way for you to describe it
21· · · ··to me.
22· ·A· ··So I believe it's -- the title is their own
23· · · ··LOM-7.1A, and that was the one that we had on file
24· · · ··that was submitted on May of 2020.
25· ·Q· ··Okay.··And how did what you observed in June differ

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·1· · · ··from that approved SOP?
·2· ·A· ··I believe, as I said, that the initial SOP didn't
·3· · · ··mention anything about adding grinding balls and
·4· · · ··how those are -- how those are handled both -- how
·5· · · ··those are handled post-homogenization.
·6· ·Q· ··What does that mean, post-homogenization?
·7· ·A· ··So, you know, it's basically -- as I said, this is
·8· · · ··I would say the analogy of these plans is kind of
·9· · · ··like a coffee grinder.··It will, you know, grind
10· · · ··flower or whatever material into it and pulverize
11· · · ··it into dust and then to kind of help that method
12· · · ··and, you know, make all the particles, you know,
13· · · ··approximately a uniform size for them to -- for one
14· · · ··to extract in methanol, that there had been no
15· · · ··mention of, you know, how they handled that.
16· · · · · · · · ··Again, the -- the -- it was -- most
17· · · ··specifically was there was no mention of -- that
18· · · ··they were adding material into that.··The material
19· · · ··I mean is the balls to homogenize that.
20· ·Q· ··Were you concerned or have any concern about any
21· · · ··type of weighing of the flower or weights that were
22· · · ··used for testing?
23· ·A· ··Well, I can't recall what our notes were, but I
24· · · ··believe maybe we did -- when we observed we
25· · · ··weren't -- they weren't really -- it wasn't laid

(517) 388-3128
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·1· · · ··out specifically what -- how much would they use to
·2· · · ··do the initial homogenization.
·3· ·Q· ··Were -- explain to me why that's a concern.
·4· ·A· ··Well, I mean, I guess if you would add -- if you
·5· · · ··add more material than with the homogenization
·6· · · ··there might be -- you know, that the percentage of
·7· · · ··different parts of the anatomy of the cannabis
·8· · · ··flower might not be truly representative.
·9· ·Q· ··So does that impact the accuracy of test results?
10· ·A· ··Yeah.··I mean, if you were to add more material, if
11· · · ··you added even just, you know, like say you're
12· · · ··adding twice the material that you should be adding
13· · · ··to it, then you would probably get out of that
14· · · ··extraction you would get more of the test analytes
15· · · ··that you're targeting.
16· ·Q· ··So by test analytes do you mean THC quantities
17· · · ··or --
18· ·A· ··Yes.··Yeah.··I mean in this amount but it would
19· · · ··probably be similar in other tests, testing too.
20· ·Q· ··Okay.··So in this -- in your inspection report you
21· · · ··noted the deficiencies.··Did you request any
22· · · ··corrective action?
23· · · · · · · · ··And if you need me to scroll through to
24· · · ··refresh your memory, please let me know.
25· ·A· ··This looks like that I had -- I think I asked them

(517) 388-3128
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·1· · · ··to -- I think both this one and the other one I
·2· · · ··asked them to -- the previous one I asked them to
·3· · · ··submit an updated approval with a validation.
·4· ·Q· ··And so what type of approval with validation for
·5· · · ··what exactly?
·6· ·A· ··For the -- well, they -- they -- they -- their
·7· · · ··contention was their method hadn't changed, but,
·8· · · ··again, it was not the same as what we had on file.
·9· · · ··So we wanted to confirm that this -- whatever
10· · · ··they're doing to change that procedure was not
11· · · ··impacting the results.
12· ·Q· ··So did you tell them this verbally, or did you put
13· · · ··it into this inspection report, or how did you
14· · · ··notify them that that was what needed to be done
15· · · ··for corrective action?
16· ·A· ··I see that there's "Please update sampling SOP to
17· · · ··reflect current testing amount," and then "Perform
18· · · ··an audit, include all -- and all steps shall be
19· · · ··submitted to Agency.··Updates must be submitted to
20· · · ··Agency for approval."
21· ·Q· ··So did that happen?
22· ·A· ··It did not.
23· ·Q· ··So you included it and you provided this inspection
24· · · ··report that we just referenced to Viridis Lansing
25· · · ··because that was what you were involved in, and you

(517) 388-3128
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·1· · · ··never received any type of documents that were
·2· · · ··pursuant to what you requested with a corrective
·3· · · ··action plan?
·4· ·A· ··Not to updates for that -- their procedure potency
·5· · · ··analysis.
·6· ·Q· ··And at any point in time did you -- were you ever
·7· · · ··involved in a Method Validation Review for a
·8· · · ··potency method for Viridis laboratories?
·9· ·A· ··So related to flower?
10· ·Q· ··Yes.
11· ·A· ··No.
12· ·Q· ··Are you aware of any point in time that there was a
13· · · ··denial that was put out of any of the way that they
14· · · ··were operating based on your observations in the
15· · · ··June of 2021 audit?
16· ·A· ··Not for -- as far as the validation -- or the
17· · · ··procedure being not approved?
18· ·Q· ··Yes.
19· ·A· ··Yes.
20· ·Q· ··And tell me what you know about that, please.
21· ·A· ··I was -- I issued a validation review report, you
22· · · ··know.··And I believe that the procedure might have
23· · · ··been presented to us but without the -- any -- the
24· · · ··requisite materials to approve that.
25· ·Q· ··Okay.··And what is a Method Validation Review

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·1· · · ··report?
·2· ·A· ··So I think I already touched on that, but it's just
·3· · · ··documenting all the required components that a
·4· · · ··validation needs based on Appendix K of AOAC and
·5· · · ··based on the published standard method performance
·6· · · ··requirements published by AOAC.
·7· ·Q· ··I'm going to share my screen again with you.··Bear
·8· · · ··with me here.
·9· · · · · · · · ··All right.··And let me know, I can make
10· · · ··this bigger as well, but I wanted to give you an
11· · · ··opportunity to take a look at the top here.
12· · · · · · · · ··Can you see that, Dr. Rosenzweig?
13· ·A· ··Yes, I can.
14· ·Q· ··All right.··And, again, do you recognize what's
15· · · ··contained in this report -- or in this document?
16· ·A· ··Yeah.··That's my Method Validation Review.
17· ·Q· ··And what does it relate to?
18· ·A· ··The cannabinoid analysis method name and SOP number
19· · · ··is documented in that table entry on the right.
20· ·Q· ··Okay.··And I'm going to scroll through slowly.
21· · · · · · · · ··Okay.··This a full, complete
22· · · ··representation of the method approval report that
23· · · ··you have issued and you have testified about?
25· · · · · · · · ··MS. HUYSER:··Okay.··At this point in

(517) 388-3128
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·1· · · ··time, Your Honor, I would ask that CRA proposed
·2· · · ··Exhibit 21 be admitted.
·4· · · ··Honor.
·9· ·Q· ··(MS. HUYSER) Doctor, as you were going through and
10· · · ··you -- you generated and drafted this report;
11· · · ··correct?
13· ·Q· ··And what was the outcome?··Was there an approval or
14· · · ··a not approval?
15· ·A· ··Not approved.··It's -- the status is up there on
16· · · ··the left, the top box.
17· ·Q· ··And can you explain to me why it was not approved?
18· ·A· ··Because there was no addendum to the report on --
19· · · ··for validation of this updated method.
20· ·Q· ··Okay.··So explain to me what you -- what you were
21· · · ··looking or what you needed to see to be able --
22· · · ··what did you want in that addendum?
23· ·A· ··That they -- that they validated this method
24· · · ··according to the AOAC guidelines of Appendix K and
25· · · ··that it met the standard method performance

(517) 388-3128
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·1· · · ··requirements published by the AOAC for cannabinoid
·2· · · ··testing in cannabis products.
·3· ·Q· ··And was this report provided to the Viridis
·4· · · ··laboratories?
·5· ·A· ··Yes.
·6· ·Q· ··And were you the one who provided it?
·7· ·A· ··I believe so, yeah.
·8· ·Q· ··Thank you.··So throughout this process there was
·9· · · ··also interlaboratory comparison tests that you had
10· · · ··mentioned earlier which is one form of oversight or
11· · · ··another form of oversight with laboratories;
12· · · ··correct?
14· ·Q· ··And explain to me a little bit about what those
15· · · ··are, please.
16· ·A· ··So we will -- the CRA will select a lab to host.
17· · · ··We will look through their inventory and make sure
18· · · ··they have product in their inventory that had
19· · · ··previously been tested and make sure that there's
20· · · ··enough product to distribute amongst all labs.
21· · · · · · · · ··We will go on site, we will -- whoever
22· · · ··the host lab is, and we will ask them to prepare
23· · · ··the samples for us and aliquot those into
24· · · ··equal-weight packages to submit to -- or for all
25· · · ··the other labs to come and pick up, and they will

(517) 388-3128
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·1· · · ··submit their testing results.
·2· ·Q· ··Since you've been involved with Viridis, either
·3· · · ··both or Viridis Lansing, have they been -- have
·4· · · ··they participated in interlaboratory comparison?
·5· ·A· ··Yes, they have.
·6· ·Q· ··And was potency one of the areas that were
·7· · · ··addressed in the interlaboratory comparisons?
·8· ·A· ··Potency analysis, yes.··But what was not addressed
·9· · · ··in this interlab is sample prep.
10· ·Q· ··And tell me why sample prep is not addressed.
11· ·A· ··We -- we didn't address sample prep -- I mean, it
12· · · ··is -- we prepped the sample but their -- if a
13· · · ··different lab is using something different they're
14· · · ··not able to do that; right?··So everyone -- it's
15· · · ··the same standard so there's no variable as far as
16· · · ··how the flower is prepped or whatever product is
17· · · ··being tested.
18· ·Q· ··So to make sure I'm understanding that correctly,
19· · · ··so the one lab, the host lab, preps every -- all of
20· · · ··the samples?
21· ·A· ··With us on site.
22· ·Q· ··With you on site.
23· ·A· ··If -- for -- if it was during COVID it might have
24· · · ··been virtual, and we would have observed that.
25· ·Q· ··So the preparation homogenization steps are not

(517) 388-3128
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·1· · · ··done by the individual labs, just the testing
·2· · · ··portion?
·3· ·A· ··No, they already get the homogenized sample.
·4· ·Q· ··So would -- do you recall if Viridis, if their
·5· · · ··results were in line with or within range with the
·6· · · ··other laboratories that were being tested?
·7· ·A· ··I believe so.
·8· ·Q· ··And is that -- was that surprising to you or
·9· · · ··unexpected to you?
10· ·A· ··I don't know if it was unexpected, no.
11· ·Q· ··Did that cause you to think or come to any
12· · · ··conclusions?
13· ·A· ··No, it was just that if it was in the mean or
14· · · ··within the range that, you know, that -- that
15· · · ··their -- that their results for that specific
16· · · ··interlab is consistent with what we see in other
17· · · ··labs.
18· ·Q· ··And at this point in time we have also discussed a
19· · · ··little bit about the potency tests, they're the
20· · · ··high-level thresholds.
21· · · · · · · · ··Why did those come into play with
22· · · ··Viridis?
23· ·A· ··I believe that there are just -- that the
24· · · ··numbers --
25· · · · · · · · ··MS. HUYSER:··Hold on one second.··Sorry.

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·1· · · ··Looks like we lost the Judge.
·2· · · · · · · · ··(Video conferencing technical issues;
·3· · · · · · · · ··off-the-record discussion.)
·4· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··I'm back.
·5· · · ··Sorry.
·6· · · · · · · · ··Now, I just switched up the internet.
·7· · · ··We'll try my hot spot connection for a while.
·8· · · ··Maybe that will be a little better.··I'm getting
·9· · · ··some communications from IT that they're working on
10· · · ··it, but I am sorry about this.
11· · · · · · · · ··You may continue, Counsel.
12· · · · · · · · ··MS. HUYSER:··I don't know if it's just me
13· · · ··so I guess I'll check with everyone else.··You are
14· · · ··already cutting in and out on my end.
15· · · · · · · · ··Could you hear, Mr. Russell and Brandon?
16· · · · · · · · ··MR. RUSSELL:··I think, yeah, he was
17· · · ··cutting and frozen a little bit, but it looks like
18· · · ··he's . . .
19· · · · · · · · ··JUDGE GOLDSTEIN:··Are you hearing me now
20· · · ··okay?
21· · · · · · · · ··MR. SCHUMACHER:··No.
22· · · · · · · · ··MR. RUSSELL:··No.
23· · · · · · · · ··JUDGE GOLDSTEIN:··You're not hearing me.
24· · · · · · · · ··MR. RUSSELL:··Heard that but . . .
25· · · · · · · · ··MS. HUYSER:··It's glitchy giving like

(517) 388-3128
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·1· · · ··that drawn-out . . .
·2· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··I think
·3· · · ··everybody -- you know what?··Everybody just take a
·4· · · ··break at this point.··I'm going to try to get this
·5· · · ··figured out.··I don't know what I'm -- what else I
·6· · · ··need to do.··Maybe I'll just do a hard boot on this
·7· · · ··computer.··But let's just break at this point.
·8· · · ··It's 11:33 AM.··Okay?··Off the record.
·9· · · · · · · · ··MR. SCHUMACHER:··What time --
10· · · · · · · · ··JUDGE GOLDSTEIN:··What?··Did you hear
11· · · ··that?
12· · · · · · · · ··MR. SCHUMACHER:··Yeah.··What time would
13· · · ··you like us back is what we were asking.
14· · · · · · · · ··JUDGE GOLDSTEIN:··Oh, say 11:45.··Okay?
15· · · · · · · · ··MS. HUYSER:··If we -- Your Honor, if you
16· · · ··want a little more time we could take an earlier
17· · · ··lunch break if that makes --
18· · · · · · · · ··JUDGE GOLDSTEIN:··Why don't we just break
19· · · ··for lunch at this point until 1:00.··Okay?
20· · · · · · · · ··MR. SCHUMACHER:··All right.
21· · · · · · · · ··JUDGE GOLDSTEIN:··And work on this for a
22· · · ··while because there is ridiculous.··I feel more
23· · · ··kind of irate about this.··We can reconvene at
24· · · ··1:00.··Thank you.

(517) 388-3128
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·2· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you.
·3· · · · · · · · ··(Lunch break taken at 11:34 AM)
·4· · · · · · · · ··(Lunch break concluded at 1:07 PM)
·5· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Back on the
·6· · · ··record in the matter of Viridis Laboratories, LLC,
·7· · · ··and Viridis North versus Cannabis Regulatory
·8· · · ··Agency, consolidated Dockets 21-029794, et al.··The
·9· · · ··time is 1:07 PM.
10· · · · · · · · ··We left off before lunch, Ms. Huyser, you
11· · · ··were continuing your examination of Dr. Rosenzweig;
12· · · ··is that correct?
13· · · · · · · · ··MS. HUYSER:··Yes, Your Honor.
14· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Go ahead.
15· · · ··My apologies for the technical problems today.
16· · · · · · · · ··MS. HUNT-SCULLY:··Judge, I'm sorry to
17· · · ··interrupt.··I think Ms. Marzorati might be waiting
18· · · ··to be let in.
19· · · · · · · · ··JUDGE GOLDSTEIN:··Thank you.··There she
20· · · ··comes.
21· · · · · · · · ··MS. HUYSER:··Do you mind if I get
22· · · ··started, Your Honor?
23· · · · · · · · ··JUDGE GOLDSTEIN:··Go ahead.··She's in.
24· · · · · · · · ··MS. HUYSER:··Okay, thank you.··Sorry, I
25· · · ··just wanted to make sure.

(517) 388-3128
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·1· ·Q· ··(MS. HUYSER) Okay.··Dr. Rosenzweig, we had
·2· · · ··discussed, and I apologize if there's some overlap
·3· · · ··but I don't want to pick up in an awkward spot,
·4· · · ··there's been some testimony and discussions about
·5· · · ··potency tests that were conducted with Viridis
·6· · · ··laboratories if they were above the high potency
·7· · · ··threshold.··Do you recall starting to discuss that?
·8· ·A· ··Yeah.
·9· ·Q· ··And what is the high potency threshold?··Like if I
10· · · ··were to say that, what is that?
11· ·A· ··29 percent.
12· ·Q· ··And how do you arrive or how did the CRA arrive at
13· · · ··that number?
14· ·A· ··So as I think I had mentioned before, based on
15· · · ··published research, the 99th percentile, which is
16· · · ··every 1 of 100 test samples would be above a
17· · · ··threshold of 27 percent, and then accounting for
18· · · ··any sort of variability in the test 29 percent was
19· · · ··the threshold.··And if it -- if we got test results
20· · · ··that were above that, that and above, then we
21· · · ··requested that the lab would confirm those results.
22· ·Q· ··And by lab, obviously, that's not just the Viridis
23· · · ··laboratories.··Is that applied equally across the
24· · · ··board?
25· ·A· ··Yes.

(517) 388-3128
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·1· ·Q· ··And have other laboratories -- excuse me.··I'll
·2· · · ··move -- scratch that.
·3· · · · · · · · ··Viridis has had to perform potency tests
·4· · · ··consistently between a certain period of time;
·5· · · ··correct?
·7· ·Q· ··Do you recall when the -- when the high potency
·8· · · ··results started and they had to be subject to the
·9· · · ··potency tests?
10· ·A· ··I don't know historically, but I know that -- I
11· · · ··believe in around November or December of 2020 it
12· · · ··became the responsibility of mine to reach out to
13· · · ··any lab that the results were above our threshold.
14· ·Q· ··And how often was that happening with Viridis
16· ·A· ··By often you mean -- what -- the numbers or was it
17· · · ··a weekly occurrence?··Is that what you're --
18· ·Q· ··Like a frequency, yes, please.
19· ·A· ··So typically they were -- all labs were audited
20· · · ··weekly.··And so most labs had some sort of results
21· · · ··that would come in weekly, so they were requested
22· · · ··on a weekly basis.
23· ·Q· ··Okay.··And what type of -- how did you arrive or
24· · · ··how did you come -- what did you use to base this
25· · · ··27 percent or the 29 percent on?··Was it just a

(517) 388-3128
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·1· · · ··number that the CRA picked out of the air?··What
·2· · · ··supports that number?
·3· ·A· ··No, as I said, it was based on some published
·4· · · ··research and peer-reviewed journals.
·5· ·Q· ··And do you recall any of those peer-reviewed
·6· · · ··journals or articles that you had looked at for
·7· · · ··that?
·8· ·A· ··Well, at the time there was one that was out there
·9· · · ··that was published in a similar regulated market in
10· · · ··the state of Washington, and that was published in
11· · · ··Nature Science Reports.
12· ·Q· ··And were there others that you had looked at other
13· · · ··than just the one?
14· ·A· ··There -- the -- there's not a ton of information
15· · · ··out there, but whatever maybe was referenced in
16· · · ··that particular journal article we might have
17· · · ··looked at other -- I might have looked at other
18· · · ··references.··And then there was a subsequent
19· · · ··article published by the same authors I think last
20· · · ··year or the year before.
21· ·Q· ··And are you confident in that number being what the
22· · · ··threshold should be?
23· ·A· ··As far as available research, yes, I'm confident.
24· ·Q· ··All right.··I'm going to show you an exhibit on the
25· · · ··screen if you can bear with me for a moment here.

(517) 388-3128
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·1· · · · · · · · ··MS. HUYSER:··Your Honor, can you allow me
·2· · · ··to share my screen, please?
·3· · · · · · · · ··JUDGE GOLDSTEIN:··You may go now.··Go
·4· · · ··ahead.
·6· ·Q· ··(MS. HUYSER) All right.··Doctor, can you see what
·7· · · ··is on the screen?
·8· ·A· ··Yes.
·9· ·Q· ··And do you recognize what that is?
10· ·A· ··Yes, I do.
11· ·Q· ··Can you please tell me what it is?
12· ·A· ··The document or the figure?
13· ·Q· ··The document first.··What is it?
14· ·A· ··The document is an investigation report.
15· ·Q· ··Okay.··And is this something that you generated?
16· ·A· ··The report itself, yes.
17· ·Q· ··Okay.··And I'm going to -- we have Attachment 6 on
18· · · ··here.··I'm going to just kind of go to the end of
19· · · ··the page.
20· · · · · · · · ··Do you recognize Attachment 6 in these
21· · · ··two tables?
22· ·A· ··Yes.
23· ·Q· ··Have there been any changes or alterations to these
24· · · ··two tables since you created them and provided
25· · · ··them?

(517) 388-3128
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·1· ·A· ··No, there hasn't.
·2· · · · · · · · ··MS. HUYSER:··Your Honor, at this point in
·3· · · ··time I would ask that CRA proposed Exhibit 8 be
·5· · · · · · · · ··JUDGE GOLDSTEIN:··CRA Exhibit 8?
·6· · · · · · · · ··Any objections to that, Counsel?
·7· · · · · · · · ··MR. SCHUMACHER:··No, Your Honor.
12· ·Q· ··(MS. HUYSER) Now, Noah, can you walk me through,
13· · · ··and I can make this a little larger if it helps to
14· · · ··see because I know it's kind of small, we'll start
15· · · ··with this chart.··Can you tell me what this pie
16· · · ··chart represents?
17· ·A· ··That is the percentage of high potency audits total
18· · · ··based on all the labs.
19· ·Q· ··Okay.··So walk me through -- tell me what you did
20· · · ··to arrive at these numbers and how you created this
21· · · ··chart.
22· ·A· ··So I compiled the total numbers of audits that
23· · · ··we've requested through all the labs, and this is
24· · · ··11 at the time, 11 labs.··So that's the -- just the
25· · · ··raw numbers.··How many -- how many were reported

(517) 388-3128
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·1· · · ··back into our statewide monitoring system.
·2· ·Q· ··And did you pick a starting point, or is this over
·3· · · ··a particular period of time?
·4· ·A· ··I believe that was from whenever we -- whenever the
·5· · · ··data, historical data, started in 2020?··I can't
·6· · · ··remember the exact date.··Up until the date at the
·7· · · ··top which is -- oh, on the top of that chart.
·8· ·Q· ··Okay.··Sorry.
·9· ·A· ··So November 26th, 2021.
10· ·Q· ··Okay.··And so tell me how you came up with this --
11· · · ··these numbers for each lab.
12· ·A· ··So there's the total number of values, and that is
13· · · ··the percentage of those total potency audits.··And
14· · · ··each piece of the pie represents what lab is
15· · · ··contributing to those numbers.
16· ·Q· ··And what was the contribution of Viridis North?
17· ·A· ··It looks like they're about 77, 78 percent?
18· ·Q· ··Are you adding the two Viridises together?··Sorry
19· · · ··if I --
20· ·A· ··Yes.··Yeah, I'm sorry.
21· ·Q· ··So combined you would add the total for Viridis
22· · · ··North and the total for Viridis?
23· ·A· ··Yeah, that's the percent that they represent of the
24· · · ··total audits.
25· ·Q· ··And if I go down to this, the second chart on

(517) 388-3128
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·1· · · ··there, what is that?
·2· ·A· ··That's the numbers, the raw numbers, that we used
·3· · · ··to calculate the percentage.
·4· ·Q· ··Okay.··So explain to me how you obtained these raw
·5· · · ··numbers.
·6· ·A· ··It's -- well, again, the same as before, based on
·7· · · ··the total numbers of potency audits requested in
·8· · · ··that time frame.
·9· ·Q· ··I'm going to move to this document over here.··This
10· · · ··has been marked as CRA proposed Exhibit 9.··If I
11· · · ··were to go through this do you recognize what this
12· · · ··is?
13· ·A· ··Yeah.
14· ·Q· ··Okay.··And what is it?
15· ·A· ··So that's looks like a summary of the amount over
16· · · ··28 percent.
17· ·Q· ··Okay.··So, like, the amount of tests that came over
18· · · ··28 percent?
19· ·A· ··I believe so, yeah.
20· ·Q· ··Okay.··And I'm just going to the end of the page to
21· · · ··make sure that there's nothing there.
22· · · · · · · · ··Is this an accurate representation of the
23· · · ··chart that you made from analyzing the data?
24· ·A· ··Yeah.
25· ·Q· ··Okay.··At this --

(517) 388-3128
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·1· ·A· ··It's --
·2· ·Q· ··-- point in time -- I'm sorry.··Go ahead, Doctor.
·3· ·A· ··I wouldn't say this is a data analysis, it's just,
·4· · · ··you know, a statistical number.··So the statistics,
·5· · · ··like raw numbers.
·6· ·Q· ··What's the difference between statistics and a data
·7· · · ··analysis?
·8· ·A· ··So these are just like summary statistics where
·9· · · ··you -- you know, it's not actually you're comparing
10· · · ··this in a statistical test, this is just what those
11· · · ··numbers are.
12· ·Q· ··Okay.··Okay.··And this is -- so I'll rephrase it
13· · · ··then -- this is an accurate statistical analysis --
14· · · ··statistical reference or chart representing those
15· · · ··statistics?
16· ·A· ··Yes.··Correct.
18· · · ··would ask that CRA proposed Exhibit 9 be admitted.
20· · · · · · · · ··MR. SCHUMACHER:··No, Your Honor.
21· · · · · · · · ··JUDGE GOLDSTEIN:··CRA Exhibit 9 is
25· ·Q· ··(MS. HUYSER) And as far as numbers, what does this

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·1· · · ··chart signify to you?
·2· ·A· ··It looks like based on the X and Y axes that it's
·3· · · ··the numbers of greater than 28 percent total THC on
·4· · · ··the Y axis and on the X axis it's the labs.··And we
·5· · · ··combined all other labs together as one.
·6· ·Q· ··All right.··Thank you.
·7· · · · · · · · ··And do you recall when the weekly potency
·8· · · ··tests stopped or were discontinued?
·9· ·A· ··Can you rephrase that question because -- you mean
10· · · ··stopped in general?
11· ·Q· ··No.··Sorry, that was a poor question.··I'll
12· · · ··apologize there.
13· · · · · · · · ··So is Viridis still performing the weekly
14· · · ··potency tests?
15· ·A· ··No, they are not.
16· ·Q· ··And is that because they're not uploading high
17· · · ··potency that's over the 29 percent threshold?
18· ·A· ··No, that's not the case.··That's still being
19· · · ··entered into Metrc.
20· ·Q· ··Okay.··So why are they no longer, if you know, and
21· · · ··if you don't know that's perfectly acceptable, but
22· · · ··why are they no longer performing the weekly high
23· · · ··potency tests?
24· ·A· ··I don't know the reason, I just know that I got
25· · · ··instructions to stop auditing.··I don't know the

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·1· · · ··justification behind it, it was just a request.
·2· ·Q· ··Okay.··And so there's been some reference to the --
·3· · · ··you as an LSS going and doing the semi-annual
·4· · · ··inspections with Dr. Chirio; correct?
·5· ·A· ··Yep.
·6· ·Q· ··And do you -- does an LSS, do you guys work in
·7· · · ··pairs regularly or was that -- what was the reason
·8· · · ··for doing that with her?
·9· ·A· ··Yeah, typically we work in pairs.··And at the time
10· · · ··there was only two of us.
11· ·Q· ··Okay.··So tell me what your roles were.
12· ·A· ··During the inspection?
13· ·Q· ··Yes.
14· ·A· ··So it would just depend on who -- whose lab was --
15· · · ··who -- which lab and which LSS was responsible for
16· · · ··oversight.··So if it was -- I was responsible for a
17· · · ··lab I would lead the inspection and go through the
18· · · ··inspection report with the licensees and Allyson
19· · · ··would just be there to observe.··And then if it was
20· · · ··the reverse then it was the opposite.
21· ·Q· ··And was there anything when you were working side
22· · · ··by side with her that caused you to have any
23· · · ··concern or alarm about her work product?
24· ·A· ··Allyson?
25· ·Q· ··Yes, Dr. Chirio, yes.

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·1· ·A· ··No.
·2· ·Q· ··And were you comfortable working in tandem and
·3· · · ··putting both of your names on the reports?
·4· ·A· ··Yeah.··Yes.
·5· ·Q· ··Thank you.··So we're going back to -- we talked
·6· · · ··about earlier that there was a denial of the June
·7· · · ··2021 submission from the Viridis laboratories
·8· · · ··regarding potency; correct?
10· ·Q· ··Okay.··And let me -- sorry, before I change topics
11· · · ··I want to make sure.
12· · · · · · · · ··All right.··I am going to share my screen
13· · · ··again with what has been marked as CRA proposed
14· · · ··Exhibit 22.··And, Doctor, can you see what that is?
15· ·A· ··Yeah.
16· ·Q· ··Okay.··I'll scroll through a little bit here, just
17· · · ··the first couple of pages.
18· · · · · · · · ··Do you recognize this document?
19· ·A· ··Yeah.
20· ·Q· ··And what is it?
21· ·A· ··It's an investigation report.
22· ·Q· ··And what -- did you author this investigation
23· · · ··report?
24· ·A· ··Uh-huh.··Yes.
25· ·Q· ··Sorry, yes?··Okay.

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·1· · · · · · · · ··And when did you author it?··Or when was
·2· · · ··it approved?··We'll use that date, or submitted
·3· · · ··date.
·4· ·A· ··Looks like in August of 2021?
·5· ·Q· ··Okay.··And if I were to scroll through slowly in
·6· · · ··here let me know if there's been any alterations or
·7· · · ··changes to the document outside of how you provided
·8· · · ··it to us.
·9· · · · · · · · ··Is this a full and complete accurate
10· · · ··representation of your report?
11· ·A· ··Yes, it is.
12· ·Q· ··Okay.··And can you tell me what laboratory this
13· · · ··related to?
14· ·A· ··It looks like Viridis --
15· ·Q· ··Okay.··And this would be the --
16· ·A· ··-- Laboratories.
17· ·Q· ··Okay.··Sorry about that.
18· · · · · · · · ··This would then be the Lansing location?
19· ·A· ··Yeah.··Should be.··If you could scroll to the top
20· · · ··it will tell me for sure.··Yep.
21· ·Q· ··Yes, sorry --
22· ·A· ··Yes.
23· ·Q· ··-- is that what that --
24· ·A· ··Yes.
25· · · · · · · · ··MS. HUYSER:··Okay.··Thank you.··So at

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·1· · · ··this point in time I would ask that proposed
·2· · · ··Exhibit 22 be admitted.
·5· · · · · · · · ··JUDGE GOLDSTEIN:··CRA 22 is admitted.
·7· ·Q· ··(MS. HUYSER) And while you were -- when you
·8· · · ··authored the report for the Lansing laboratory did
·9· · · ··you also author a report for the Viridis North
10· · · ··laboratory?
11· ·A· ··Possibly --
12· ·Q· ··Okay.
13· ·A· ··-- but -- probably, but then again I can't remember
14· · · ··sort of when that transition was between Patrice
15· · · ··and I.
16· ·Q· ··Absolutely.··I have put on the screen what has been
17· · · ··marked as proposed Exhibit 23.··Please go ahead and
18· · · ··take a look.··I'll scroll down a little bit, and
19· · · ··tell me if you recognize this document.
20· · · · · · · · ··Do you recognize it thus far?
21· ·A· ··Yes.
22· ·Q· ··Okay.··And what do you recognize it to be?
23· ·A· ··An investigation report that I authored.
24· ·Q· ··Okay.··And, again, I'll go slowly -- go quickly
25· · · ··through to the bottom.··Tell me if there's anything

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·1· · · ··that's missing, and then I'll go back up to the
·2· · · ··top.
·3· · · · · · · · ··Does this report accurately reflect or
·4· · · ··this document accurately reflect the report that
·5· · · ··you had created?
·6· ·A· ··Yes, it does.
·7· ·Q· ··Any changes, alterations, or anything left out of
·8· · · ··the document?
·9· ·A· ··No, not that I can see.
10· ·Q· ··Okay.··And can you tell me what this report
11· · · ··pertains to?
12· ·A· ··I believe that one is the -- can you show -- can
13· · · ··you show me what the complaint number is real
14· · · ··quick?
15· · · · · · · · ··I believe that is potency.
16· ·Q· ··Okay.··And this is for Viridis North laboratory?
18· ·Q· ··And is it -- is it similar or identical to the
19· · · ··report that you generated for Viridis Lansing that
20· · · ··has been previously admitted?
21· ·A· ··Most likely it's very similar.
22· · · · · · · · ··MS. HUYSER:··Okay.··At this point in time
23· · · ··I would ask that CRA proposed Exhibit 23 be

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·5· · · · · · · · ··JUDGE GOLDSTEIN:··Uh-huh.
·7· ·Q· ··(MS. HUYSER) Okay, let me -- and, Doctor, do you
·8· · · ··recall drafting an additional investigative report
·9· · · ··in December of 2021?
10· ·A· ··I'm sure that I have, yes.
11· ·Q· ··Okay.··I will share my screen and show you this
12· · · ··report.
13· · · · · · · · ··Okay.··Can you see what is on the screen?
14· ·A· ··Uh-huh.··Yes.
15· ·Q· ··Okay.··And I'll go slowly through it, but do you
16· · · ··recognize this document?
17· ·A· ··Yes, I do.
18· ·Q· ··Okay.··And I'm going to just kind of go a little
19· · · ··faster through to the bottom because this one's a
20· · · ··little lengthier.
21· · · · · · · · ··Is this a full and complete and accurate
22· · · ··representation of the report that you had generated
23· · · ··in December of 2021?
24· ·A· ··Yes, it is.
25· ·Q· ··Okay.··Any changes or alterations?··I know I moved

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·1· · · ··quickly, but from anything that jumped out or stood
·2· · · ··out to you?
·3· ·A· ··I don't believe so, no.
·4· · · · · · · · ··MS. HUYSER:··At this point in time I
·5· · · ··would ask that CRA proposed Exhibit 24 be admitted.
11· · · · · · · · ··JUDGE GOLDSTEIN:··Uh-huh.
13· ·Q· ··(MS. HUYSER) Now, Noah, you drafted this in
14· · · ··relation to Viridis North; correct?
15· ·A· ··Yes.
16· ·Q· ··And if I was to show you this list of associated
17· · · ··cases right now does that mean anything to you?
18· ·A· ··I mean, it only means that these are likely cases
19· · · ··that are related to this complaint, but from just
20· · · ··the numbers I wouldn't know exactly what the -- is
21· · · ··in those complaints but . . .
22· ·Q· ··Just something related to Viridis North?
23· ·A· ··Yeah.
24· ·Q· ··Or Viridis Lansing; is that fair?

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·1· ·Q· ··Okay.··At some point in time did it -- was it
·2· · · ··brought to your attention or did you become aware
·3· · · ··of an on-site audit happening in October of 2021?
·4· ·A· ··By the CRA?
·5· ·Q· ··Yes.
·6· ·A· ··Yes.
·7· ·Q· ··Okay.··Do you know why there was an on-site audit
·8· · · ··conducted?
·9· ·A· ··I believe it was triggered by a -- what's called a
10· · · ··Metrc ticket request for a change of test status.
11· ·Q· ··Okay.··And tell me a little bit -- explain that to
12· · · ··me because I'm not familiar with that that means.
13· ·A· ··So if a product is tested in our -- and the results
14· · · ··are entered in our statewide monitoring system and
15· · · ··there's subsequent tests, let's say there is a
16· · · ··failure initially, there may be some retests done
17· · · ··and the -- the licensee will request that that
18· · · ··status be updated, and Metrc, who's the third-party
19· · · ··provider of our statewide monitoring system, will
20· · · ··reach out to us to request an update on that.
21· ·Q· ··And what about that process would make you think
22· · · ··that you have to -- or require or cause the CRA to
23· · · ··want to do an on-site audit?
24· ·A· ··I believe that there was -- the licensee -- we
25· · · ··requested further information from the licensee

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·1· · · ··that we were asking about documenting incubation
·2· · · ··times for a microbial test, because I believe this
·3· · · ··was a microbial test failure that needed test
·4· · · ··update, and that I did not make that request, but
·5· · · ··whoever was in charge of the Metrc tickets
·6· · · ··requested that.··And the response we got back was
·7· · · ··that they don't document the in and out times of
·8· · · ··their incubation process which was -- was of
·9· · · ··concern.
10· ·Q· ··And the response that -- when you said "they," who
11· · · ··are you referring to?
12· ·A· ··Whoever at Viridis, their -- whoever was in charge
13· · · ··of -- of requesting their updates.··I don't --
14· · · ··can't recall the person's name or anything.
15· ·Q· ··But "they" being Viridis?
16· ·A· ··Viridis, yes.
17· ·Q· ··Okay.
18· ·A· ··And what -- sorry.
19· ·Q· ··No, go ahead, please.
20· ·A· ··And I believe what happened was there were -- and I
21· · · ··may be wrong in my recollection, again, this is
22· · · ··almost two years ago, so I believe that this -- the
23· · · ··person who wanted the testing, the licensee who
24· · · ··wanted the testing, sent it out to two different
25· · · ··places and it failed at one place and passed at

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·1· · · ··Viridis.··And we also followed up with those --
·2· · · ··that -- that question about incubation time.
·3· ·Q· ··Okay.··So who all went on site in October of 2021?
·4· ·A· ··I believe that it was me, Patrice Fields, another
·5· · · ··LSS, Allyson Chirio, another LSS at the time, and
·6· · · ··Claire Patterson, scientific section manager.
·7· ·Q· ··Okay.··And you -- what happened when you arrived at
·8· · · ··the facility?··Walk me through -- when you walk in
·9· · · ··the doors what did you do?
10· · · · · · · · ··Hold on just a second.
11· · · · · · · · ··MS. HUYSER:··Judge, can you hear us?
12· · · · · · · · ··JUDGE GOLDSTEIN:··I'm here.··I'm fine.
13· · · · · · · · ··MS. HUYSER:··Okay.··Sorry, I just saw a
14· · · ··change and wanted to make sure.
15· · · · · · · · ··JUDGE GOLDSTEIN:··I'm fine.
16· · · · · · · · ··THE WITNESS:··I believe we sat down and
17· · · ··had a meeting with them and went through some
18· · · ··documentation.··And at the time I think it was
19· · · ··shortly after they had an audit from their
20· · · ··accreditors, and the accreditor, one of the
21· · · ··deficiencies was they were not tracking the
22· · · ··temperature in their incubators.
23· ·Q· ··(MS. HUYSER) And what does that impact?
24· ·A· ··Well, I believe many of these testing methodologies
25· · · ··are developed by a manufacturer, and they state

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·1· · · ··explicitly that any warranty is voided if they're
·2· · · ··not adhering to the specific criteria that was used
·3· · · ··to validate that method.
·4· ·Q· ··So to take a step back, you guys were all there,
·5· · · ··all four of you?
·6· ·A· ··Uh-huh.
·7· ·Q· ··Did you -- were you each assigned a task, or did
·8· · · ··you move together in a group?··What did you do?
·9· ·A· ··Yeah, we were each assigned a task.··So I believe
10· · · ··we first had a meeting, then we asked to, you know,
11· · · ··observe and question some of their analysts about
12· · · ··their processes.··And I was -- my responsibility
13· · · ··was for the microbial testing.
14· ·Q· ··Okay.··So I'm going to start kind of at a very
15· · · ··basic level.
16· · · · · · · · ··What is a microbial?
17· ·A· ··So as I talked about earlier, as far as plant
18· · · ··pathogens go a microbe is a bacteria, a fungi, a
19· · · ··virus.··Also nematodes which are small worms.
20· · · ··Again, those are also considered a microbe.
21· ·Q· ··And do these same type of microbials -- and, you
22· · · ··know, you were talking about them in general for
23· · · ··plants.··Obviously, cannabis is a plant; right?
24· ·A· ··Yep.
25· ·Q· ··And do you --

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·1· ·A· ··Yes.
·2· ·Q· ··-- do you see those same type of microbials as
·3· · · ··something in the cannabis plants?
·4· ·A· ··You mean are there similar pathogens that are
·5· · · ··generalized pathogens as well as specific to
·6· · · ··cannabis?··Is that what you -- is your question?
·7· ·Q· ··I'll even make it even more simple.
·8· · · · · · · · ··Microbials.··Do they affect the cannabis
·9· · · ··plant?
10· ·A· ··Yes.
11· ·Q· ··And what types of microbials do you see -- or do --
12· · · ··are you looking for with the cannabis?
13· ·A· ··So there are I believe five separate tests that are
14· · · ··required for the product.··Two are the total yeast
15· · · ··and mold, so most fungi that will -- can grow on
16· · · ··the plant.··And most of these are what in plant
17· · · ··pathology we call are, like, postharvest diseases.
18· · · · · · · · ··So there's total yeast and mold, so all
19· · · ··of the total yeast and mold that grow in it.
20· · · ··Coliforms, which are bacteria, and they are like
21· · · ··the E. colis, and they can cause foodborne illness.
22· · · · · · · · ··So there's total yeast and mold, total
23· · · ··coliforms.··And those are quantitative methods so
24· · · ··they have to enumerate the number that are on
25· · · ··there.··And there's a threshold for whether the

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·1· · · ··product passes or fails.
·2· · · · · · · · ··And then additionally there are specific
·3· · · ··targeted ones, so not just general total coliforms
·4· · · ··on total yeast but specific fungi, and those are
·5· · · ··the aspergillus.··And then specific bacteria which
·6· · · ··are the E. coli and salmonella.
·7· ·Q· ··And are these things of concern if they are on the
·8· · · ··cannabis product or the flower that's going out
·9· · · ··into the market?
10· ·A· ··Yeah.··Yes.
11· ·Q· ··And why is that?
12· ·A· ··Well, particularly for the coliforms and the
13· · · ··bacteria they can cause, like, foodborne illness,
14· · · ··diarrhea, all that fun stuff when you get food
15· · · ··poisoning.
16· · · · · · · · ··And then for the yeast and mold they
17· · · ··can -- if they're in particularly inhalable
18· · · ··products they can cause -- they can contaminate the
19· · · ··lungs, particularly in immune-compromised patients.
20· · · ··So they -- they affect the lungs mostly.
21· ·Q· ··So when you mentioned that there were -- you
22· · · ··divided up to look at these microbials why was it
23· · · ··you that went to microbials versus looking at
24· · · ··foreign matter or potency?
25· ·A· ··Just because that's my area of training and

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·1· · · ··expertise is in pathogens and the microbes that
·2· · · ··grow on and in plants.
·3· ·Q· ··So did you have -- are you familiar with the
·4· · · ··standard operating procedure that's on file for
·5· · · ··microbials with the Viridis laboratories?
·6· ·A· ··Yes, I am.
·7· ·Q· ··And tell me a little bit about what that is.··What
·8· · · ··are they required to do?
·9· ·A· ··So in general they're required to initially
10· · · ··incubate the sample at a certain temperature for a
11· · · ··certain amount of time.··And for the specific, the
12· · · ··targeted pathogens of name that I mentioned, they
13· · · ··use a DNA-based approach just called PCR,
14· · · ··polymerase chain reaction.··I don't need to go into
15· · · ··the detail but it's, you know, very common
16· · · ··technology that's used in most clinical labs they
17· · · ··use similarly for COVID, to detect COVID.··So . . .
18· · · · · · · · ··And then for the -- similarly for the
19· · · ··quantitative or to enumerate them they will be
20· · · ··incubated again for a certain amount of time.··And
21· · · ··depending on the platform, then you determine how
22· · · ··much growth has occurred in that time frame.
23· ·Q· ··So if the SOPs, do they contain a range of time
24· · · ··that they should be incubated for?··Is it a
25· · · ··specific number?··What does that -- what does it

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·1· · · ··read?
·2· ·A· ··Well, I guess it's dependent on which method and
·3· · · ··which platform they're using, but sometimes the
·4· · · ··tolerance is -- it's usually they have a specific
·5· · · ··temperature, and that can be plus and minus a
·6· · · ··degree or something.··And then they have a specific
·7· · · ··time of incubation.
·8· ·Q· ··And Viridis's -- we'll just refer to them as
·9· · · ··Viridis collectively, which means I'm referring to
10· · · ··both -- their SOP, does it prescribe a particular
11· · · ··range or does it reference a particular platform?
12· · · ··How do you know what they're expected to do or what
13· · · ··they have been approved to do?
14· ·A· ··So, again, these platforms have been developed by a
15· · · ··manufacturer.··And when you get these kits from the
16· · · ··manufacturer they'll come with instructions, and
17· · · ··you need to follow those step by step.
18· · · · · · · · ··So typically what a licensee will do is
19· · · ··just take that and work that into their procedure
20· · · ··exactly how it's stated in the manufacturer's
21· · · ··instructions.
22· ·Q· ··And in the -- for the -- the procedure for Viridis
23· · · ··did it indicate particular types of logs would be
24· · · ··kept or documentation would be kept?
25· ·A· ··I don't believe it explicitly said that.

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·1· ·Q· ··So how -- are they required to do that if it
·2· · · ··doesn't explicitly say that?
·3· ·A· ··I would say that the warranty says that they --
·4· · · ··that the manufacturer will take no responsibility
·5· · · ··if it doesn't follow the instructions for use, the
·6· · · ··IFU.··So one would interpret that is if you cannot
·7· · · ··document that then how would one know if they're
·8· · · ··actually following the procedure.
·9· ·Q· ··And by -- when I use the word logs or keeping
10· · · ··track, is it the expectation that it be a paper
11· · · ··log, or can it be any other format used to track
12· · · ··time in, time out, and temperature?
13· ·A· ··I mean, it could be electronically.··Maybe this is
14· · · ··incubated in a certain vessel or a container or
15· · · ··something and that could be marked on that.··But it
16· · · ··would seem that it might be not really efficient to
17· · · ··be writing it on there because you might have to
18· · · ··keep that waste in case you need that documentation
19· · · ··for later on to prove that you did, indeed, follow
20· · · ··those directions.
21· · · · · · · · ··So, again, it's sort of something that
22· · · ··you learn early on in some of your basic chemistry,
23· · · ··biology classes how to keep a journal and the data.
24· · · ··Data notebook.
25· ·Q· ··Why is it important when you're talking about

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·1· · · ··microbials to keep a temperature or time log?
·2· ·A· ··So many of these organisms have a specific range
·3· · · ··where they grow well at and a certain time when
·4· · · ··they grow.
·5· · · · · · · · ··So let's say you're at a lower
·6· · · ··temperature and at a shorter time you won't get as
·7· · · ··much growth as you might if it was at the
·8· · · ··appropriate time or at a -- or let's say you maybe
·9· · · ··were -- your temperature was too high and you left
10· · · ··it for too long you would probably get more growth.
11· · · ··And that might not, as I said, adhere to the
12· · · ··manufacturer's warranty.
13· ·Q· ··So just to make sure I'm understanding this
14· · · ··correctly, that if you're cooking it too -- if
15· · · ··you're putting it in there too low of a temperature
16· · · ··or too short of a time, it may not grow enough to
17· · · ··be visible but it could still be there?
18· ·A· ··That's correct, although in the DNA-based approach
19· · · ··it's not about observing it visually it's
20· · · ··amplifying the DNA and using that piece of DNA to
21· · · ··identify it.
22· ·Q· ··So is that something done under a microscope if you
23· · · ··can't visually observe it or is it a chemical test?
24· ·A· ··It's done on a machine that's called a thermal
25· · · ··cycler.

(517) 388-3128
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·1· ·Q· ··So it's not like you could pick it up and look at
·2· · · ··it and say, "Hey, look, there's -- there's
·3· · · ··microbials there?"
·4· ·A· ··Well, that depends.··I mean, that depends on your
·5· · · ··level of expertise; right?
·6· · · · · · · · ··So if someone were to show me a bag of
·7· · · ··incubating product that had aspergillus in it I
·8· · · ··would probably be able to identify that based on my
·9· · · ··experience and work with this particular pathogen.
10· ·Q· ··So when you broke off to look at microbials, what
11· · · ··microbial in particular caused you any concern?
12· ·A· ··I don't remember if it was a specific one, it was
13· · · ··more just interviewing their tech on how the
14· · · ··process and how they do that and how they're
15· · · ··documenting time in, time out, and temperature.
16· ·Q· ··And what did you learn about that?
17· ·A· ··I was told that they don't document that.
18· ·Q· ··So how do they know how long something's been in
19· · · ··there?
20· ·A· ··I don't -- I don't know.··They said they typically
21· · · ··put it in the same time each day or whatever.··But,
22· · · ··again, this is -- that doesn't seem like a
23· · · ··customary way of doing that.
24· ·Q· ··Did it cause you alarm or were you concerned about
25· · · ··the accuracy of the testing for microbials if they

(517) 388-3128
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·1· · · ··were not able to show you when it was in and when
·2· · · ··it was out?
·3· ·A· ··Yes.
·4· ·Q· ··And after you were -- you spoke and you went
·5· · · ··through and you're involved with the microbials,
·6· · · ··did you generate a report at that point in time?
·7· ·A· ··An investigation report?
·8· ·Q· ··Yes, sir.
·9· ·A· ··I believe there was one subsequent to the on-site,
10· · · ··yes.
11· ·Q· ··Okay.··All right.··I have shared my screen with you
12· · · ··as what's been marked as CRA proposed Exhibit 38.
13· · · ··Can you see that?
14· ·A· ··Yes.
15· ·Q· ··Okay.··I'm going to go through the first just
16· · · ··couple little ways, and tell me if you recognize
17· · · ··what this is.
18· · · · · · · · ··Do you recognize it at this point?
19· ·A· ··Yes.··Yes, I do.
20· ·Q· ··Okay.··And what do you recognize it to be?
21· ·A· ··An investigation report that I authored.
22· · · · · · · · ··MS. HUYSER:··Was that just me?
23· · · · · · · · ··THE WITNESS:··It was frozen for me.
24· · · · · · · · ··MR. SCHUMACHER:··You disappeared on our
25· · · ··screen too.

(517) 388-3128
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·1· · · · · · · · ··MS. HUYSER:··Is it back now?
·2· · · · · · · · ··MR. SCHUMACHER:··Yes.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Your turn to get kicked
·4· · · ··of.
·5· · · · · · · · ··MS. HUYSER:··Let's hope not.
·6· · · · · · · · ··All right.··So at the point where I --
·7· · · ··let me share this exhibit again.
·8· · · · · · · · ··MR. SCHUMACHER:··I think we just lost
·9· · · ··Noah.··Oh, there he is.
10· · · · · · · · ··MS. HUYSER:··Do we have Noah?
11· · · · · · · · ··THE WITNESS:··Yeah, I'm here.··Can you
12· · · ··hear me?··Can you hear me?
13· · · · · · · · ··JUDGE GOLDSTEIN:··I hear you fine.
14· · · ··Ms. Huyser seems to be frozen.
15· · · · · · · · ··THE WITNESS:··Yeah.
16· · · · · · · · ··JUDGE GOLDSTEIN:··And I think we lost her
17· · · ··and --
18· · · · · · · · ··MR. SCHUMACHER:··It looks like we lost
19· · · ··all of the Attorney Generals.
20· · · · · · · · ··JUDGE GOLDSTEIN:··Yeah.··Okay, you know
21· · · ··what?··Let's just take a break at this point.··We
22· · · ··need to see if I can get my camera to work.··I got
23· · · ··some reading done a little bit suggesting I reboot
24· · · ··my computer.··So I'm going to conclude the meeting
25· · · ··until I can reboot my computer.··Why don't we break

(517) 388-3128
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·1· · · ··until 2:10.
·2· · · · · · · · ··MR. SCHUMACHER:··All right, Your Honor.
·3· · · ··We'll rejoin.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Thank you.
·5· · · ··Off the record at 1:51.
·6· · · · · · · · ··MR. SCHUMACHER:··Thank you, Your Honor.
·7· · · · · · · · ··(Break taken at 1:51 PM)
·8· · · · · · · · ··(Break concluded at 2:13 PM)
·9· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··We're back
11· · · ··Laboratories, LLC, and Viridis North versus
13· · · ··Numbers 21-029794, et al.··The time is 2:13 PM.
14· · · · · · · · ··Okay, Ms. Huyser, you had a comment you
15· · · ··wanted to make?
16· · · · · · · · ··MS. HUYSER:··Just to -- yeah, a brief
17· · · ··inquiry of both Viridis counsel and the Court.
18· · · · · · · · ··Obviously, we're sitting here at 2:15.
19· · · ··Who knows what's going to happen from here.··I
20· · · ··think all of us expected to be through our
21· · · ··witnesses a little quicker than it's going.··But
22· · · ··rather than -- by the time we get through
23· · · ··Dr. Rosenzweig and then -- I'm getting close, but I
24· · · ··still have a little bit longer with cross.
25· · · · · · · · ··Is there any expectation that you would

(517) 388-3128
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·1· · · ··want us to call our third witness or not start a
·2· · · ··witness that we know we won't finish and come back
·3· · · ··to -- have to come back to them in a few months?
·4· · · · · · · · ··JUDGE GOLDSTEIN:··The tribunal's
·5· · · ··expectation that you call a third witness today you
·6· · · ··mean?
·7· · · · · · · · ··MS. HUYSER:··Yes.
·8· · · · · · · · ··JUDGE GOLDSTEIN:··I don't think I had an
·9· · · ··expectation, necessarily.
10· · · · · · · · ··If you start your witness today and you
11· · · ··think you're going to get through Dr. Rosenzweig
12· · · ··early with cross-examination, I don't know how
13· · · ··early we -- you know.··So . . .
14· · · · · · · · ··MR. SCHUMACHER:··I can weigh in, Your
15· · · ··Honor.··We will -- I can almost guarantee we will
16· · · ··not be done with Dr. Rosenzweig today.
17· · · · · · · · ··MS. HUYSER:··Okay.··That helps.··I just
18· · · ··have witnesses asking me how long that they can sit
19· · · ··around and what a projected time frame is.··So
20· · · ··trying to kind of get an impression for that is all
21· · · ··I was trying to do.
22· · · · · · · · ··JUDGE GOLDSTEIN:··Let me suggest this.
23· · · ··Okay?
24· · · · · · · · ··MR. RUSSELL:··Yeah, and I guess -- and
25· · · ··the other thing is too, is there any objection to

(517) 388-3128
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·1· · · ··us concluding at four today?
·2· · · · · · · · ··JUDGE GOLDSTEIN:··I was going to --
·3· · · ··actually, I was going to say I needed to conclude
·4· · · ··at 4:30 today anyway.
·5· · · · · · · · ··What I was going to suggest is that,
·6· · · ··Ms. Huyser, if you think you'll get done with
·7· · · ··Dr. Rosenzweig with your direct today?
·8· · · · · · · · ··MS. HUYSER:··Yes.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··Don't feel that you
10· · · ··have to, but if you do then we can conclude so that
11· · · ··counsel for Viridis, you don't have to start your
12· · · ··cross and then --
13· · · · · · · · ··MR. SCHUMACHER:··I can hold off on the
14· · · ··cross until the next -- that's fine, Your Honor.
15· · · · · · · · ··JUDGE GOLDSTEIN:··I was also going to
16· · · ··talk about a couple of potential hearing dates in
17· · · ··between now and August to clear it on my calendar.
18· · · ··So we can talk about that later.··Okay?
19· · · · · · · · ··MR. SCHUMACHER:··All right.
20· · · · · · · · ··MS. HUYSER:··Thank you.··Sorry to disrupt
21· · · ··at that point, I just felt as though it might be a
22· · · ··good planning . . .
23· · · · · · · · ··JUDGE GOLDSTEIN:··That's fine.··But we
24· · · ··will, at a minimum, try to conclude at 4:00 today
25· · · ··if not earlier.··Okay?

(517) 388-3128
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·2· · · · · · · · ··JUDGE GOLDSTEIN:··Dr. Rosenzweig, you're
·3· · · ··still under oath.··Thank you.
·4· · · · · · · · ··THE WITNESS:··(Moves head up and down)
·5· · · · · · · · ··JUDGE GOLDSTEIN:··You may continue,
·6· · · ··Counsel.··Go ahead.
·7· · · · · · · · ··MS. HUYSER:··Thank you.··Can you allow me
·8· · · ··to share my screen, please?
·9· · · · · · · · ··JUDGE GOLDSTEIN:··Resets every time.
10· · · · · · · · ··Okay, we should be good.
12· ·Q· ··(MS. HUYSER) Doctor, can you see this screen?··I
13· · · ··know, if I recall, we were kind of going through
14· · · ··and looking down through this.
15· ·A· ··Yes, I can.
16· ·Q· ··Okay.··And did you -- you recognize what this
17· · · ··document is; correct?
18· ·A· ··Yes, I do.
19· ·Q· ··And what is this document?
20· ·A· ··I believe that's an investigation report that I
21· · · ··authored.
22· ·Q· ··And when did you author this?
23· ·A· ··It looks like 11/1/2021?··So this was subsequent to
24· · · ··the on-site I believe.
25· ·Q· ··Okay.··And what laboratory does this relate to?

(517) 388-3128
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·1· ·A· ··That relates to Viridis Laboratories Lansing.
·2· ·Q· ··Okay.··And I'm going to briefly go down to the
·3· · · ··bottom.··Obviously, you know, let me know if
·4· · · ··anything -- if this doesn't look like it has
·5· · · ··been -- if it looks like it's been altered or
·6· · · ··changed in any way, shape, or form.··And if I'm
·7· · · ··going too quickly, let me know that, too.
·8· · · · · · · · ··Is this a full and complete, accurate
·9· · · ··representation of the report that you had drafted?
10· ·A· ··Yes, it is.
11· · · · · · · · ··MS. HUYSER:··Okay.··At this point in
12· · · ··time, Your Honor, I would ask that CRA proposed
13· · · ··Exhibit 38 be admitted.
20· ·Q· ··(MS. HUYSER) And as you -- since you're familiar
21· · · ··with this report, you indicated, and I want to make
22· · · ··sure I heard you correctly, that this was authored
23· · · ··and drafted after you did your on-site
24· · · ··investigation?

(517) 388-3128
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·1· ·Q· ··Okay.··Would it help if you -- like, do you need to
·2· · · ··look at anything to assure that?
·3· ·A· ··From my recollection the on-site occurred in
·4· · · ··October.
·5· ·Q· ··Okay.
·6· ·A· ··It might be documented in here.··So yes, this is
·7· · · ··after that on-site.
·8· ·Q· ··Okay.··And I'm going to change over to what has
·9· · · ··been marked as CRA's proposed Exhibit 39.··And I
10· · · ··know that this is an attachment to that report, but
11· · · ··do you recognize what this is?
12· ·A· ··Yes.
13· ·Q· ··Can you take an opportunity to tell me what this is
14· · · ··and how you recognize it?
15· ·A· ··Yeah, that's similar to the potency which is just
16· · · ··the total number of failures -- or the number of
17· · · ··tests -- the top one looks like the number of tests
18· · · ··per -- per laboratory.··So that's the total number
19· · · ··of tests that they performed on aspergillus, and
20· · · ··then the second one is the failures per laboratory.
21· ·Q· ··Okay.··And have there been any alterations or
22· · · ··changes to these charts since you provided it to
23· · · ··our office?
24· ·A· ··Not that I see, no.

(517) 388-3128
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·1· · · ··would ask that Petitioner's -- or excuse me --
·2· · · ··CRA's proposed Exhibit 39 be admitted.
·4· · · · · · · · ··MR. SCHUMACHER:··No objection.
·9· ·Q· ··(MS. HUYSER) Doctor, I'm going to zoom in a little
10· · · ··bit farther into these test charts that you have
11· · · ··done.··We'll start with the top one.··If you need
12· · · ··me to move, please let me know.
13· · · · · · · · ··Where did the data that was, I don't want
14· · · ··to use the word "analyze" but the statistics or the
15· · · ··data come from that you used to generate this
16· · · ··report -- or this chart?
17· ·A· ··So the summary statistics that are represented in
18· · · ··this chart came from data pulled from the statewide
19· · · ··monitoring system, Metrc.
20· ·Q· ··Metrc.··Okay.··And similar to potency, can you
21· · · ··please describe what this chart is and what it
22· · · ··represents in relation to Viridis?
23· ·A· ··So that's just how many total number of tests that
24· · · ··they performed in whatever time frame this data
25· · · ··came from.

(517) 388-3128
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·1· ·Q· ··And what does this -- so this just tells you the
·2· · · ··percentage of all of the tests and the time frame?
·3· ·A· ··Yes.
·4· ·Q· ··Okay.··So to make sure I understand, Viridis North
·5· · · ··would have done 12.77 percent and Viridis Lansing
·6· · · ··would have done 14.69 percent?
·7· ·A· ··Yes, so the total testing.
·8· ·Q· ··Okay.··And all of these that are labeled over here
·9· · · ··are other -- the other licensed labs in the state
10· · · ··of Michigan?
11· ·A· ··Yes, that's correct.
12· ·Q· ··And, again, describe this chart to me, please, and
13· · · ··what it represents.
14· ·A· ··That is the total number of failures per facility
15· · · ··for aspergillus.
16· ·Q· ··And what do these numbers -- do these have any type
17· · · ··of value, or does this cause you to come to any
18· · · ··conclusions?
19· ·A· ··What it -- what I see in -- is that based on the
20· · · ··total numbers, that many of the other labs are
21· · · ··consistent with the percentage of how many failures
22· · · ··with -- related to how many total tests, whereas at
23· · · ··least for Viridis North and Viridis Lansing they
24· · · ··are much -- much less reporting failures than the
25· · · ··total other labs out of the total number of tests.

(517) 388-3128
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·1· ·Q· ··And how many other labs do you oversee including
·2· · · ··Viridis?
·3· ·A· ··At this point I think ten?
·4· ·Q· ··And with these other labs have you conducted
·5· · · ··microbial audits or reviewed their SOPs for
·6· · · ··microbials with these other labs?
·7· ·A· ··Yes.
·8· ·Q· ··And do other labs keep some type of documentation
·9· · · ··for temperature or time in and out?
10· ·A· ··Yes, they do.
11· ·Q· ··Do you know of any other labs that do not?
12· ·A· ··Of the ones that I oversee I don't recall that
13· · · ··there's any that don't record in and out times.
14· ·Q· ··All right.··I'm going to show you what's been
15· · · ··marked as CRA proposed Exhibit 40.··And can you
16· · · ··please take a second to look at this document and
17· · · ··tell me if you recognize what it is?
18· ·A· ··Yes, it's an investigation report that I authored.
19· ·Q· ··Okay.··And the attachment, do you recognize that?
20· ·A· ··Yes.
21· ·Q· ··And can you tell me what that is?
22· ·A· ··That is the third-party accreditor's assessment of
23· · · ··Viridis North and what they were deficient in their
24· · · ··audit.
25· ·Q· ··Okay.··And you included this in your report;

(517) 388-3128
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·1· · · ··correct?
·2· ·A· ··Yes.
·3· ·Q· ··So it's a document that you relied upon for making
·4· · · ··determinations and as you were doing -- going
·5· · · ··through with the on-site audit?
·6· ·A· ··I believe this was given to us or we saw this at
·7· · · ··the on-site audit.··So we were not made aware of
·8· · · ··this when this happened during the assessment dates
·9· · · ··but we were made aware of it subsequent when we
10· · · ··went on site and requested this.
11· ·Q· ··And this was provided from Viridis?
13· ·Q· ··I'm going to scroll to the bottom at this point,
14· · · ··and tell me if there's been any alterations or
15· · · ··changes to this document.
16· · · · · · · · ··Does this accurately represent the report
17· · · ··that you were provided?
18· ·A· ··Yes, it does.
19· · · · · · · · ··MS. HUYSER:··At this point in time I'm
20· · · ··going to ask that CRA Exhibit -- proposed Exhibit
21· · · ··40 be admitted.

(517) 388-3128
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·3· ·Q· ··(MS. HUYSER) And this report indicates that it's a
·4· · · ··deficiency report or deficiency summary.··Please
·5· · · ··explain to me what that is.
·6· ·A· ··So this when their accreditor went to them on
·7· · · ··on-site assessment to recertify them -- I think
·8· · · ··this is recertification -- and they noted what was
·9· · · ··deficient based on their ISO requirements for
10· · · ··17025.
11· ·Q· ··And can you tell me what they noted to be
12· · · ··deficient?··And if you need to scroll to a
13· · · ··particular place --
14· ·A· ··No, I don't.··They just noted that they were
15· · · ··recording their temperatures of their incubator.
16· ·Q· ··And did they put forth any type of corrective
17· · · ··action or any -- request anything be done with
18· · · ··that?
19· ·A· ··Did the assessor?
20· ·Q· ··Yes.
21· ·A· ··I believe, yes, they -- they would require that for
22· · · ··them to recertify them.
23· ·Q· ··And when you were there in October did you still
24· · · ··observe the same deficiencies?
25· ·A· ··No, I believe at that time they were -- they did

(517) 388-3128
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·1· · · ··have a sheet that they were logging temperatures.
·2· ·Q· ··Were they logging times?
·3· ·A· ··They were not on that sheet.··That was just for the
·4· · · ··instrumentation.
·5· ·Q· ··Okay.··I'm going to move to what's been marked as
·6· · · ··CRA proposed Exhibit 41.··And can you -- do you
·7· · · ··recognize what this is?
·8· ·A· ··Yes.
·9· ·Q· ··And can you tell me what it is, please?
10· ·A· ··That's the incubator temperature log for Viridis
11· · · ··Lansing.
12· ·Q· ··Okay.··And was this provided to you from Viridis
13· · · ··Lansing?
15· ·Q· ··So when you review this temperature log tell me,
16· · · ··does it provide any concerns or cause you any
17· · · ··concern or anything that should be noted?
18· ·A· ··I believe that the boxes that are highlighted is
19· · · ··where the instrumentation was not within the
20· · · ··required tolerance that's stated in the
21· · · ··manufacturer's protocol for their microbial testing
22· · · ··platform.
23· ·Q· ··So just to make sure I'm understanding, it was
24· · · ··either too high or too low?
25· ·A· ··Yes.

(517) 388-3128
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·1· ·Q· ··So in this period of time from this looks like it
·2· · · ··would be August 10th of 2021 to October 6th I
·3· · · ··believe it looks like of 2021, all of these
·4· · · ··instances are times that it was outside of the
·5· · · ··range?
·6· ·A· ··I believe so, yes.··I cannot -- I didn't commit
·7· · · ··this to memory, but that's likely what I'm
·8· · · ··highlighting in this.
·9· ·Q· ··And you did those highlights; correct?
10· ·A· ··Yes.
12· · · ··would ask that CRA proposed Exhibit 41 be admitted.
15· · · · · · · · ··JUDGE GOLDSTEIN:··CRA Exhibit 41
18· ·Q· ··(MS. HUYSER) And I'm now showing you what's been
19· · · ··marked as CRA proposed Exhibit 42.··And take a
20· · · ··second -- if you'd like me to enlarge this let me
21· · · ··know because it is kind of small -- and tell me if
22· · · ··you recognize what this attachment is.
23· ·A· ··Yes, that's the what we would refer to as the
24· · · ··package insert or the instructions for the Tempo
25· · · ··platform which is what the facility -- I don't know

(517) 388-3128
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·1· · · ··if they've changed, I don't think they have
·2· · · ··changed -- but that they were using to do
·3· · · ··qualitative -- quantitative microbial testing.
·4· ·Q· ··At the time of your on-site?
·5· ·A· ··Yes.
·6· ·Q· ··So in October of 2021?
·8· ·Q· ··And why is this important?
·9· ·A· ··That I believe I highlighted in there what the
10· · · ··required time and testing -- sorry -- time and
11· · · ··temperature requirements are for testing to adhere
12· · · ··to their instructions for use.
13· ·Q· ··And how does this connect to the standard operating
14· · · ··procedures?
15· ·A· ··So if they are using these platforms, these
16· · · ··microbial platforms, what they would do is they
17· · · ··would perform what's called a verification which is
18· · · ··that they would run this platform and just verify
19· · · ··that it works appropriately at the lab as it
20· · · ··should.
21· ·Q· ··Okay.··So have there been any alterations to these
22· · · ··instructions or this attachment since it was last
23· · · ··provided?
24· ·A· ··By me?
25· ·Q· ··Yes.

(517) 388-3128
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·1· ·A· ··No.
·2· ·Q· ··It's an accurate representation of what should be
·3· · · ··followed per the instructions of the manufacturer?
·4· ·A· ··Yes, that's correct.··It's -- it's basically a
·5· · · ··document from the manufacturer.
·6· · · · · · · · ··MS. HUYSER:··At this point in time, Your
·7· · · ··Honor, I would ask that CRA proposed Exhibit 42 be
10· · · · · · · · ··MR. SCHUMACHER:··I would object to this,
11· · · ··Your Honor, on the grounds of foundation.··I
12· · · ··understand he's testifying this is the
13· · · ··manufacturer's instructions, but there's been no
14· · · ··SOP introduced.··There's been no testimony
15· · · ··connecting it to the SOP.··These are just
16· · · ··manufacturer's instructions.
17· · · · · · · · ··MS. HUYSER:··He has testified that this
18· · · ··was the platform for the instrument that was being
19· · · ··used and that it is part of what has to be done
20· · · ··for -- which he's testified a couple different
21· · · ··times that these instructions have to be followed
22· · · ··and the guidelines have to be followed for the
23· · · ··results to be considered accurate and for the
24· · · ··warranty to be present.··So there has been enough
25· · · ··testimony connecting this manufacturer's insert to

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·1· · · ··the material that is at the laboratory.
·2· · · · · · · · ··JUDGE GOLDSTEIN:··I'll admit the exhibit.
·4· · · · · · · · ··JUDGE GOLDSTEIN:··Uh-huh.
·6· ·Q· ··(MS. HUYSER) And on this last page here I know that
·7· · · ··you have testified about the warranty and you have
·8· · · ··referenced it before.··Is this what you have --
·9· · · ··when you've said that there is a -- if it's not
10· · · ··being performed within these specs then the test
11· · · ··result will not be warrantied by the manufacturer?
13· ·Q· ··And this is Tempo.··It says it relates to coliform
14· · · ··count.··Can you tell me what that means?
15· ·A· ··That's the -- one of the quantitative microbial
16· · · ··methods.··So we want to -- we -- the lab should be
17· · · ··quantifying how many total coliform cells are
18· · · ··growing after a particular incubation time.
19· ·Q· ··I'm going to move to what's --
20· · · · · · · · ··JUDGE GOLDSTEIN:··Dr. Rosenzweig, can I
21· · · ··ask you a question here?
22· · · · · · · · ··THE WITNESS:··Yes, Your Honor.
23· · · · · · · · ··JUDGE GOLDSTEIN:··Incubate the cards for
24· · · ··22 to 28 hours.··What are the cards?
25· · · · · · · · ··THE WITNESS:··So what these cards look

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·1· · · ··like, they have -- they have little -- let me
·2· · · ··see -- like capillary tubes, and those tubes are
·3· · · ··filled with growth media that's conducive to growth
·4· · · ··of the bacteria in this case.··And so they would
·5· · · ··add a suspension of the macerated plant tissue with
·6· · · ··the growth media into these cards.··And so it's
·7· · · ··basically looking at a color change which is -- the
·8· · · ··term is called optical density of those.··So it
·9· · · ··reads the optical density of those, and from that
10· · · ··it will calculate the total number of bacteria in
11· · · ··that sample.
12· · · · · · · · ··Is that clear, Your Honor?
13· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··And so this
14· · · ··relates to your earlier testimony about the
15· · · ··readings that you found out of range because they
16· · · ··were higher or lower than the numbers on these --
17· · · ··in the manufacturer's instructions here?
18· · · · · · · · ··THE WITNESS:··Correct.··The temperature
19· · · ··was out of range.
20· · · · · · · · ··JUDGE GOLDSTEIN:··All right.
21· · · · · · · · ··THE WITNESS:··I'm sorry to interrupt,
22· · · ··Your Honor.
23· · · · · · · · ··JUDGE GOLDSTEIN:··I understand.··The
24· · · ··cards is just a -- the instrument they use to test
25· · · ··the --

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·1· · · · · · · · ··THE WITNESS:··It's the vehicle for which
·2· · · ··the target bacteria grow.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··Thank you.
·4· · · · · · · · ··Go ahead, Counsel.
·6· ·Q· ··(MS. HUYSER) I'm going to show you what's been
·7· · · ··marked as CRA proposed Exhibit 43 and it has
·8· · · ··attachment 8.··And can you tell me what this is,
·9· · · ··please?
10· ·A· ··Can you scroll further?
11· ·Q· ··Absolutely.··And I can make it --
12· ·A· ··Okay.··Okay, this one is the similar platform, the
13· · · ··Tempo platform, but this is for -- I'm looking at
14· · · ··yeast and mold.
15· ·Q· ··So similar to what we admitted as the platform for
16· · · ··42 that -- for coliforms, this is what would be the
17· · · ··same platform that gives the numbers and the
18· · · ··requirements for total yeast and mold?
19· ·A· ··Yes.··So the previous one was to enumerate how many
20· · · ··bacterial cells are growing, and this is similar to
21· · · ··that but it looks at the fungi.··And that -- that
22· · · ··CFU per gram is colony forming units, so how many
23· · · ··colonies you'll see growing.
24· ·Q· ··Okay.··And as I scroll through it puts forth the
25· · · ··time and the plus or minus for the temperature same

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·1· · · ··as the other document; correct?
·2· ·A· ··That's correct, yes.
·3· ·Q· ··Is this an accurate representation of that entire
·4· · · ··platform, instruction sheet?
·5· ·A· ··Yes, it is.··That is the instruction sheet itself.
·6· ·Q· ··Okay.··And once again does that connect back to the
·7· · · ··same manufacturer or same unit that is being used
·8· · · ··in the Viridis laboratories?
·9· ·A· ··Yes, that's the Tempo platform.
10· · · · · · · · ··MS. HUYSER:··Thank you.··At this point in
11· · · ··time I would ask that CRA proposed Exhibit 43 be
14· · · · · · · · ··MR. SCHUMACHER:··Same objection, Your
15· · · ··Honor.··This isn't the SOP itself.··The SOP hasn't
16· · · ··been introduced, and these are just manufacturer's
17· · · ··instructions.··And I understand that the tribunal
18· · · ··will likely let this in, I just want to make sure
19· · · ··that objection is noted.
20· · · · · · · · ··JUDGE GOLDSTEIN:··Okay, Counsel, your
21· · · ··objection is noted.
22· · · · · · · · ··CRA Exhibit 43 is admitted.

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·1· ·Q· ··(MS. HUYSER) And, again, the same thing, Doctor.
·2· · · ··This has been marked as CRA proposed Exhibit 44.
·3· · · ··And can you -- I'll zoom in a little bit more into
·4· · · ··this.··Can you tell me what this is, please?
·5· · · · · · · · ··Perhaps I went too far.
·6· ·A· ··Yeah.··Yes, I can.
·7· ·Q· ··And what is this?
·8· ·A· ··That is the manufacturer's instructions for the
·9· · · ··platform that was in use at the time to detect the
10· · · ··specific genera of fungi, the aspergillus.
11· ·Q· ··So all of these platforms, do they have to have a
12· · · ··different platform for each type of microbial?
13· ·A· ··Could you please restate the question, Sarah?
14· ·Q· ··I'm sorry, the nonscientist in me may have worded
15· · · ··that poorly.
16· · · · · · · · ··We're seeing a bunch of different
17· · · ··platforms.··Why is that?
18· ·A· ··As I mentioned before for the microbial tests that
19· · · ··are required there's five different targets that
20· · · ··they use.··There may be somewhere you can combine
21· · · ··these, which the term is called multiplexing them,
22· · · ··but there's also ones where you can just do them
23· · · ··individually.
24· ·Q· ··And once again this is connected to the same type
25· · · ··of instrument and platform that is being used in

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·1· · · ··Viridis laboratories; correct?
·2· ·A· ··That's correct, at the time.
·3· ·Q· ··At that time, yes.
·4· · · · · · · · ··All right.··As I scroll down please tell
·5· · · ··me if there's been any alterations or changes to
·6· · · ··this platform as it has been provided.
·7· ·A· ··There is not.
·8· ·Q· ··Okay.··And can you look and tell me, again, this
·9· · · ··contains the same temperature requirements and time
10· · · ··requirements; correct?
12· · · · · · · · ··MS. HUYSER:··At this point in time I will
13· · · ··ask that CRA proposed Exhibit 44 be admitted.
16· · · ··Honor.
17· · · · · · · · ··JUDGE GOLDSTEIN:··Okay, objection's
18· · · ··noted.··CRA Exhibit 44 is admitted.
20· ·Q· ··(MS. HUYSER) And I'm going to do the same thing
21· · · ··with Exhibit 45, Doctor.··Do you recognize what is
22· · · ··right here and what has been marked as proposed
23· · · ··Exhibit 45?
24· ·A· ··Yes.
25· ·Q· ··And can you tell me what that is?

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·1· ·A· ··That is the manufacturer instructions for the
·2· · · ··Gene-Up platform that is used to detect E. coli.
·3· ·Q· ··And, once again, that is connected back to the same
·4· · · ··platform that is used in Viridis laboratories?
·5· ·A· ··Yes, that's correct, that was within approved use
·6· · · ··at the time.
·7· ·Q· ··Okay.··Any alterations or changes to this document
·8· · · ··since you have provided it?
·9· ·A· ··No.
11· · · ··time I would ask that proposed Exhibit 45 be
15· · · ··Honor.
16· · · · · · · · ··JUDGE GOLDSTEIN:··CRA 45 is admitted.
19· ·Q· ··(MS. HUYSER) And for the last platform we're going
20· · · ··to move on to -- excuse me, too big -- proposed
21· · · ··Exhibit 46.
22· · · · · · · · ··Can you please tell me what this is?
23· ·A· ··Yes, I can.
24· ·Q· ··And what is it?
25· ·A· ··Similarly to the other four that you've shown me,

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·1· · · ··this is the manufacturer's instructions and is what
·2· · · ··the SOP that Viridis verified and were using at the
·3· · · ··time.
·4· ·Q· ··So this is the platform that's been approved and
·5· · · ··the platform that should have been followed;
·6· · · ··correct?
·8· ·Q· ··Okay.··Any changes or alterations to this document
·9· · · ··since it was last provided?
10· ·A· ··No, there is not.
12· · · ··time I would move for proposed Exhibit 46 to be
13· · · ··admitted, Your Honor.
15· · · · · · · · ··MR. SCHUMACHER:··Yes, Your Honor.··The
16· · · ··witness testified for the SOP that was verified.
17· · · ··There has been no SOP introduced.··This is just the
18· · · ··manufacturer's instructions again.
19· · · · · · · · ··MS. HUYSER:··There has been discussion
20· · · ··throughout the testimony when we started to move on
21· · · ··to microbials that there was an SOP that has been
22· · · ··approved and that that SOP was something that
23· · · ··Dr. Rosenzweig reviewed and he indicated that it
24· · · ··did require compliance with the platforms.
25· · · · · · · · ··JUDGE GOLDSTEIN:··You mean compliance

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·1· · · ··with the platforms listed in the manufacturer's
·2· · · ··warranty information?··Is that what you're talking
·3· · · ··about, Ms. Huyser?
·4· · · · · · · · ··MS. HUYSER:··Yes.··He testified to a
·5· · · ··connection between the requirements as did Claire
·6· · · ··Patterson, Your Honor.
·7· · · · · · · · ··JUDGE GOLDSTEIN:··Do you have a comment,
·8· · · ··Counsel?
·9· · · · · · · · ··MR. SCHUMACHER:··I still just object on
10· · · ··the lack of foundation.··I don't recall that
11· · · ··testimony.
12· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Well, I
13· · · ··will -- the record speaks for itself and will admit
14· · · ··the exhibit.··CRA Exhibit 46 is admitted.
17· ·Q· ··(MS. HUYSER) I'm going to move . . .
18· ·A· ··Before you move on, Counselor, may I just add one
19· · · ··thing to that?
20· · · · · · · · ··I did not clarify that these methods are
21· · · ··what are called PTMs, performance tested methods,
22· · · ··and they have a certificate for that and based on
23· · · ··that certificate these have to be followed
24· · · ··according to both that -- the performance tested
25· · · ··method certificate that's issued for this platform

(517) 388-3128
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·1· · · ··as well as what the manufacturer's instructions
·2· · · ··say.
·3· ·Q· ··So who gets a performance -- a PTM?··Who gets
·4· · · ··issued that certificate?
·5· ·A· ··For these particular methods the vendor would.
·6· ·Q· ··Okay.··So Gene-Up or the ones that said bioMérieux?
·7· ·A· ··Yes.··So Gene-Up is one of bioMérieux's platforms.
·8· ·Q· ··Okay.··So bioMérieux would be what you're referring
·9· · · ··to when you refer to a vendor?
10· ·A· ··And they're -- it does have that little stamp up
11· · · ··there.··You see that?
12· ·Q· ··This one?
13· ·A· ··Performance test method right there.··Yep.
14· ·Q· ··Okay.··Thank you.
15· · · · · · · · ··All right.··I'm moving on to what has
16· · · ··been marked as CRA proposed Exhibit 49, and I'm
17· · · ··going to scroll through slowly.··Please let me know
18· · · ··if you recognize what this is.
19· ·A· ··Yep, I do.
20· ·Q· ··Please tell me what -- please tell me what it is.
21· ·A· ··It looks like that was a summary of the auditor's
22· · · ··findings based on the on-site.
23· ·Q· ··And referring to that, that's the on-site that was
24· · · ··performed in October of 2021; correct?
25· ·A· ··Yep.··Date of audit 10/26/2021.

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·1· ·Q· ··And you assisted and reviewed with the drafting of
·2· · · ··this document; correct?
·3· ·A· ··I don't know if I checked off on the time, but I
·4· · · ··probably included my findings on this document.
·5· ·Q· ··And these -- this accurately reflects this on-site
·6· · · ··audit findings document and it's -- you have seen
·7· · · ··the final form; correct?
·9· ·Q· ··You've reviewed it as a record that is regularly
10· · · ··kept with the CRA any time an on-site audit is
11· · · ··done?
12· ·A· ··Yes, I've reviewed that.··It's been some time but I
13· · · ··have reviewed that.··I haven't probably reviewed it
14· · · ··since it was finalized though.
15· ·Q· ··Okay.··But it is an accurate -- from me scrolling
16· · · ··through this it is an accurate representation of
17· · · ··the on-site audit that was performed; correct?
19· · · · · · · · ··MS. HUYSER:··At this point I would ask
20· · · ··that CRA proposed Exhibit 49 be admitted.

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·2· ·Q· ··(MS. HUYSER) And in addition to that what is 49,
·3· · · ··which is the findings, did you also do a -- sorry,
·4· · · ··bear with me one second.··I think I opened up
·5· · · ··something twice.··No.
·6· · · · · · · · ··This one is for which laboratory?
·7· ·A· ··That one is the on-site audit findings from Viridis
·8· · · ··Laboratories in Lansing.
·9· ·Q· ··Okay.··And let's move to what's been marked as
10· · · ··proposed Exhibit 51.··I'm going to go quickly
11· · · ··through this document, and let me know if you
12· · · ··recognize it.
13· ·A· ··Yes, I do.
14· ·Q· ··Okay.··And what do you recognize this to be?
15· ·A· ··That looks like the companion document for Viridis
16· · · ··North Laboratories of their on-site.
17· ·Q· ··So it's a similar report as what we had as proposed
18· · · ··Exhibit 49 -- or excuse me Exhibit 49 -- but for
19· · · ··Viridis North; correct?
21· ·Q· ··Is it an accurate reflection of a record that was
22· · · ··created regarding the on-site findings that you
23· · · ··have reviewed?
24· ·A· ··Yes, to the best of my recollection this is that.
25· ·Q· ··Okay.

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·1· ·A· ··Represents that.
·2· ·Q· ··Without any changes or alterations from the
·3· · · ··method -- or from when it was provided to you last;
·4· · · ··correct?
·7· · · ··would ask that proposed Exhibit 51 be admitted.
13· ·Q· ··(MS. HUYSER) And, Doctor, I'm going to show you
14· · · ··what's been marked as CRA proposed Exhibit 47.··Can
15· · · ··you take a chance to look at this, an opportunity
16· · · ··to look at this, and tell me if you know what it
17· · · ··is?
18· ·A· ··Yes, I do.
19· ·Q· ··Okay.··And what is it?
20· ·A· ··That is part of Viridis's quality manual, Section
21· · · ··7.10.
22· ·Q· ··And what does it pertain to?
23· ·A· ··That pertains to non-conforming work.
24· ·Q· ··I'm going to scroll through these pages that are
25· · · ··here, and tell me if this is a full, complete

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·1· · · ··representation of the 7.10 non-conforming work
·2· · · ··quality -- quality analysis -- this is going to be
·3· · · ··a long day -- regulation from Viridis.
·4· ·A· ··Yes, that's their three-page document.
·5· ·Q· ··Thank you.··Any changes or alterations?
·6· ·A· ··No.
·8· · · ··would ask that CRA proposed Exhibit 47 be admitted.
15· ·Q· ··(MS. HUYSER) And, Doctor, what is a non-conforming
16· · · ··work?
17· ·A· ··That's when any sort of lab processes are not
18· · · ··conformed to what the requirements are based on
19· · · ··whatever that particular test is.
20· ·Q· ··So if you find these deficiencies or other things
21· · · ··that have been noted, is that fair to say?
22· ·A· ··That looks like their process to identify those and
23· · · ··to document those.
24· ·Q· ··Okay.··And you're familiar with what their process
25· · · ··requires?

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·1· ·A· ··Yes, from -- just from reading this, yes.
·2· ·Q· ··And if there is a non-conforming work that is
·3· · · ··found, what should happen?
·4· ·A· ··Well, they should be able to identify that, and
·5· · · ··then they need to -- I believe they state that they
·6· · · ··have to determine if there's risk involved and what
·7· · · ··sort of corrective actions they need to do to make
·8· · · ··sure that it doesn't happen again, do they need to
·9· · · ··recall the reports, is there some concern that
10· · · ··reporting that the non-conforming work affected the
11· · · ··results of the test.
12· ·Q· ··And why is that important to have this type of
13· · · ··procedure or process in place?
14· ·A· ··Well, I would say that no human is perfect, so
15· · · ··there may be mistakes in the lab or either --
16· · · ··that -- that -- that happen so they need to make
17· · · ··sure they can identify those.
18· · · · · · · · ··MS. HUYSER:··Excuse me for a second while
19· · · ··I stop sharing my screen.
20· · · · · · · · ··At this point in time, Your Honor, I have
21· · · ··no further questions on direct for Dr. Rosenzweig.
22· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··So the plan was
23· · · ··then to adjourn before we start cross-examination,
24· · · ··correct, Counsel for Viridis?
25· · · · · · · · ··MR. SCHUMACHER:··That's fine, Your Honor,

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·1· · · ··yes.··I'm going to have quite a bit with
·2· · · ··Dr. Rosenzweig.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··So let's
·4· · · ··talk about potential openings in my calendar.
·5· · · · · · · · ··MS. HUYSER:··All right.··Your Honor,
·6· · · ··would you like Dr. Rosenzweig to stay on, or does
·7· · · ··he have permission to leave?
·8· · · · · · · · ··JUDGE GOLDSTEIN:··Well, he would be
·9· · · ··continuing; right?
10· · · · · · · · ··MS. HUYSER:··He would be.
11· · · · · · · · ··JUDGE GOLDSTEIN:··So if he wants to stick
12· · · ··around if he's available those days he can check
13· · · ··his calendar, I just want to make sure that we can
14· · · ··do it as efficiently as possible.
15· · · · · · · · ··All right.··So I have June 6 and 7 and
16· · · ··the 8th free now.
17· · · · · · · · ··MR. SCHUMACHER:··Your Honor, I'm actually
18· · · ··walking into a jury trial on the 12th, so if there
19· · · ··are other dates available in June I would
20· · · ··appreciate that.
21· · · · · · · · ··MR. RUSSELL:··I have a nonjury trial in
22· · · ··Jackson County on the 6th.
23· · · · · · · · ··MR. SCHUMACHER:··You have a nonjury trial
24· · · ··on the 6th?
25· · · · · · · · ··MR. RUSSELL:··Yeah.

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·1· · · · · · · · ··MR. SCHUMACHER:··Okay.··And then
·2· · · ··Mr. Russell has a nonjury trial on the 6th.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··But the 7th and
·4· · · ··8th are bad too with your jury trial, Counsel,
·5· · · ··right?
·6· · · · · · · · ··MR. SCHUMACHER:··Yeah, I'll be in prep
·7· · · ··for that.··And it looks as though we have a
·8· · · ··settlement conference with the judge on the 8th.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··I have an isolated day
10· · · ··here on June 28, a Wednesday.··Try to get two in a
11· · · ··row but, you know, they go kind of quick.
12· · · · · · · · ··Anybody available on that date?
13· · · · · · · · ··MS. HUYSER:··We -- I believe that we are.
14· · · · · · · · ··Dr. Rosenzweig, are you?
15· · · · · · · · ··THE WITNESS:··Yes, I'm available.
16· · · · · · · · ··JUDGE GOLDSTEIN:··June 28th?··Is that
17· · · ··okay with everybody?
18· · · · · · · · ··MR. SCHUMACHER:··Your Honor, we're just
19· · · ··verifying the calendar.
20· · · · · · · · ··We tried that date before, Your Honor.
21· · · ··One of the Viridis representatives is going to be
22· · · ··in Norway without internet.
23· · · · · · · · ··JUDGE GOLDSTEIN:··When are they getting
24· · · ··back from Norway?
25· · · · · · · · ··MR. RUSSELL:··When do you come back?

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·1· · · · · · · · ··MR. SCHUMACHER:··July 5th.
·2· · · · · · · · ··MR. RUSSELL:··July 5th.
·3· · · · · · · · ··JUDGE GOLDSTEIN:··How about July 6th?
·4· · · · · · · · ··MR. RUSSELL:··July 6th does not work for
·5· · · ··me, Your Honor.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··Let's see here.··All
·7· · · ··right.··So July 25th possibility.··26th or the 27th
·8· · · ··are both possibilities.··Move around on cases.
·9· · · ··So . . .
10· · · · · · · · ··MR. SCHUMACHER:··The 26th and 27th work
11· · · ··on our end.
12· · · · · · · · ··MS. HUYSER:··I believe they work for us
13· · · ··as well if they work for Dr. Rosenzweig.
14· · · · · · · · ··THE WITNESS:··Yep, they should be okay.
15· · · · · · · · ··JUDGE GOLDSTEIN:··Okay.··All right.··So
16· · · ··you'll need an order for July 26th and 27th.··And
17· · · ··we're also scheduled August 23rd and 24th.··Okay?
18· · · · · · · · ··MS. HUYSER:··Yes, sir.
19· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Very good.
20· · · ··Anything before we conclude?
21· · · · · · · · ··MR. SCHUMACHER:··No, Your Honor, nothing
22· · · ··from Viridis.
23· · · · · · · · ··JUDGE GOLDSTEIN:··From the Agency?
24· · · · · · · · ··MS. HUNT-SCULLY:··I have nothing.
25· · · · · · · · ··MS. HUYSER:··(Moves head from side to

(517) 388-3128
Page 788
·1· · · ··side)
·2· · · · · · · · ··JUDGE GOLDSTEIN:··Did you send documents
·3· · · ··to my secretary, Mr. Hagar?
·4· · · · · · · · ··MR. RUSSELL:··Yes.
·5· · · · · · · · ··MR. SCHUMACHER:··Yes.
·6· · · · · · · · ··JUDGE GOLDSTEIN:··And last night?··This
·7· · · ··morning?
·8· · · · · · · · ··MR. SCHUMACHER:··Yesterday.
10· · · · · · · · ··MR. RUSSELL:··Yesterday.
11· · · · · · · · ··JUDGE GOLDSTEIN:··SharePoint, is that
12· · · ··what you're using?
13· · · · · · · · ··MR. RUSSELL:··ShareFile.
14· · · · · · · · ··JUDGE GOLDSTEIN:··ShareFile?
15· · · · · · · · ··MR. SCHUMACHER:··Your Honor, given that
16· · · ··we have some time, would you like us to just put
17· · · ··them either on a hard drive or a flash drive and
18· · · ··just get them down to your office?
19· · · · · · · · ··JUDGE GOLDSTEIN:··I think if you can put
20· · · ··them on -- a hard drive would be fine or a little
21· · · ··flash drive would be fine as long as it's not
22· · · ··locked and I don't need a code or anything.
23· · · · · · · · ··MR. SCHUMACHER:··Right.
24· · · · · · · · ··JUDGE GOLDSTEIN:··So that would be ideal,
25· · · ··a flash drive.··That would be very helpful because

(517) 388-3128
Page 789
·1· · · ··I've noted some of the exhibits are out of order in
·2· · · ··my list because I'm expecting that it's not in my
·3· · · ··list here, so . . .
·4· · · · · · · · ··All right.··So we'll see everybody then
·5· · · ··on July 26th.··Okay?
·6· · · · · · · · ··MR. SCHUMACHER:··Thank you.
·7· · · · · · · · ··MR. RUSSELL:··Thank you, Your Honor.
·8· · · · · · · · ··MS. HUNT-SCULLY:··Thank you.
·9· · · · · · · · ··JUDGE GOLDSTEIN:··We're concluded.··It is
10· · · ··2:57 PM.··Good afternoon, everyone.··Bye now.
11· · · · · · · · ··MS. HUNT-SCULLY:··Thank you.
13· · · · · · · · ··(Record closed at 2:57 PM)
14· · · · · · · · · ··*· ··*· ··*· ··*· ··*
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(517) 388-3128
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·1· · · · · · · · ·CERTIFICATE OF NOTARY PUBLIC

· ··
·2· ·
· ··
·3· · · ··I certify that this transcript, consisting of pages
· ··
·4· ·644-790, is a complete, true, and correct transcript of the
· ··
·5· ·proceedings and testimony taken in this case on May 24,
· ··
·6· ·2023.
· ··
·7· ·
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·8· ·
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·9· ·
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· ··
12· ·June 7, 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
· ··
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(517) 388-3128

Viridis-CRA Contested Hearing Transcript May 23 and May 24

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Viridis-CRA Contested Hearing Transcript May 23 and May 24

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Viridis v CRA, Vol.

·1· · · · · · · · · · · · STATE OF MICHIGAN

·1· ·REMOTE APPEARANCES:

Suzanne Duda, CSR, RPR, CRR

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

·2· ·WITNESS:· · · · · · · · · · · · · · · · · · · · · ·PAGE

·3· ·CLAIRE PATTERSON

·4· · · ··Cross-Examination, Cont., by Mr. Russell· · · ·442

·5· · · ··Voir Dire Examination by Ms. Huyser· · · · · ··591

·6· · · ··Redirect Examination by Ms. Huyser· · · · · · ·592

·7· · · ··Recross Examination by Mr. Russell· · · · · · ·619

·8· · · ··Redirect Examination, Cont., by Ms. Huyser· · ·640

·9· · · · · · · · · · ··INDEX OF EXHIBITS

10· ·VIRIDIS EXHIBITS ADMITTED:· · · · · · · · · · · · ·PAGE

11· · · ··Viridis Exhibit 14· · · · · · · · · · · · · · ·446

12· · · ··Viridis Exhibit 15· · · · · · · · · · · · · · ·484

13· · · ··Viridis Exhibit 16· · · · · · · · · · · · · · ·513

14· · · ··Viridis Exhibit 17· · · · · · · · · · · · · · ·555

15· · · ··Viridis Exhibit 18· · · · · · · · · · · · · · ·564

16· · · ··Viridis Exhibit 19· · · · · · · · · · · · · · ·568

17· · · ··Viridis Exhibit 20· · · · · · · · · · · · · · ·586

18· · · ··Viridis Exhibit 21· · · · · · · · · · · · · · ·592

Suzanne Duda, CSR, RPR, CRR

·1· · · · · · · · · · · · · · · · ·Tuesday, May 23, 2023

·4· · · · · · · · ··JUDGE GOLDSTEIN:··Good morning.··We're on

·5· · · ··the record in the matter of Viridis Laboratories,

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

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

·8· · · ··22-017866, 22-018127, 22-018128, and then

10· · · · · · · · ··Now, today's date is May 23rd, 2023.

11· · · ··It's the date set for contested -- or continued

12· · · ··hearing in the matter.

13· · · · · · · · ··Let's get some appearances starting with

14· · · ··the Cannabis Regulatory Agency, please.

15· · · · · · · · ··MS. HUNT-SCULLY:··Good morning.

16· · · ··Risa Hunt-Scully appearing on behalf of the

17· · · ··Cannabis Regulatory Agency.

18· · · · · · · · ··JUDGE GOLDSTEIN:··And on behalf of the --

19· · · · · · · · ··MS. HUYSER:··Good morning, Your Honor.

20· · · ··Sarah Huyser on behalf of the Cannabis Regulatory

22· · · · · · · · ··JUDGE GOLDSTEIN:··And on behalf of

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

25· · · ··David Russell on behalf of Viridis North, LLC, and

Suzanne Duda, CSR, RPR, CRR

·1· · · ··Viridis Laboratories, LLC.

·2· · · · · · · · ··MR. SCHUMACHER:··Good morning,

·3· · · ··Your Honor.··Brandon Schumacher on behalf of

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

·5· · · · · · · · ··JUDGE GOLDSTEIN:··All right.··Before we

·6· · · ··get going this morning, I want to bring to the

·7· · · ··parties' attentions -- to the parties' attention

·8· · · ··correspondence that the tribunal received late last

·9· · · ··Friday from an individual named Gus Burns from

10· · · ··MLive, a media outlet, and it was addressed to me,

11· · · ··although I'm not a party to the case, it was still

12· · · ··somewhat of an ex parte communication, regarding

14· · · ··hearing to the public and to the media.··So I am

16· · · ··see it.

17· · · · · · · · ··One minute here.

18· · · · · · · · ··Okay.··So I've set it, by the way, so

19· · · ··everybody can share the screen.··All right.··So I'm

20· · · ··going to share the email at this point.

21· · · · · · · · ··No, that's the wrong one.··Never mind.