ML24116A143
| ML24116A143 | |
| Person / Time | |
|---|---|
| Issue date: | 02/07/2024 |
| From: | Brian Zaleski NRC/NSIR/DPCP/RSB |
| To: | |
| References | |
| ML24037A122, NRC-2708 | |
| Download: ML24116A143 (1) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
10 CFR PART 26, FITNESS FOR DUTY PROGRAMS - QUESTION AND ANSWER SESSION ON THE "DRUG AND ALCOHOL TESTING: TECHNICAL ISSUES AND EDITORIAL CHANGES" RULEMAKING Docket Number:
N/A Location:
Videoconference Date:
02-07-2024 Work Order No.:
NRC-2708 Pages 1-114 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1716 14th Street, N.W.
Washington, D.C. 20009 (202) 234-4433
1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com UNITED STATES OF AMERICA 1
NUCLEAR REGULATORY COMMISSION 2
+ + + + +
3 10 CFR PART 26, FITNESS FOR DUTY PROGRAMS - QUESTION 4
AND ANSWER SESSION ON THE "DRUG AND ALCOHOL TESTING:
5 TECHNICAL ISSUES AND EDITORIAL CHANGES" RULEMAKING 6
+ + + + +
7 WEDNESDAY, 8
FEBRUARY 7, 2024 9
+ + + + +
10 The meeting convened via 11 Videoconference, at 1:00 p.m. EST, Brian Zaleski, 12 Specialist - Fitness For Duty, presiding.
13 14 NRC STAFF PRESENT:
15 BRIAN ZALESKI, Office of Nuclear Security and 16 Incident Response 17 STEWART SCHNEIDER, Senior Project Manager, Office 18 of Nuclear Material Safety and Safeguards 19 ANTHONY BOWERS, Chief - Reactor Security Branch, 20 Office of Nuclear Security and Incident Response 21 ALSO PRESENT:
22 TAMMY BOND, Nuclear Energy Institute 23 MATT DEIGNAN, Entergy 24 JOHNNY ROGERS, Nuclear Energy Institute 25
2 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com TABLE OF CONTENTS 1
Page 2
Introductions
3 3
NRC Presentation 11 4
Adjourn 114 5
6 7
8 9
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
3 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com P R O C E E D I N G S 1
1:03 p.m.
2 MR. ZALESKI: All right. My name is 3
Brian Zaleski. I'm a Fitness for Duty / Access 4
Authorization Specialist at the U.S. NRC. Let me 5
just swap that screen out. Today's public meeting 6
is about the Technical Issues and Editorial Changes 7
Rulemaking. It's a question-and-answer session, 8
and I'll go through what that means in a second.
9 I'm still accepting some people to the meeting.
10 On this meeting today is Stewart 11 Schneider, Senior Project Manager in Rulemaking.
12 He and I will be working on this rulemaking 13 activity together. Stew and I worked on the last 14 rulemaking, the 2022 Part 26 final rule and the 15 2019 Part 26 proposed rule.
16 All right. So, the purpose of the 17 meeting today is to engage stakeholders and to have 18 a conversation about a future rulemaking that's 19 been on the books for quite a while but that has 20 been, so to speak, on the back-burner. We were 21 focused on the rulemaking that we just completed.
22 The technical issues rulemaking was a companion 23 rulemaking, but the one the agency was focusing on 24 was the HHS guidelines, aligning with the HHS 25
4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com guidelines panel changes, and that's what we just 1
completed in 2022.
2 Okay. Opening remarks will be a very 3
simple conversation here, just to lay out the 4
ground rules for what this meeting is. Again, this 5
is a
public meeting to engage stakeholders.
6 Anybody that's on this meeting is able to 7
communicate with the NRC and ask questions about 8
this rulemaking activity. The purpose of this 9
meeting is for us to receive questions about and to 10 talk about key topic areas that we're evaluating 11 and considering for the next rulemaking, this tech 12 issues rulemaking.
13 There are categories of meetings that 14 the NRC hosts. This one is called an information 15 meeting -- I'm going to mute everybody again. This 16 is an information meeting with a question-and-17 answer session. So what that means is that the NRC 18 is going to make a presentation, participants of 19 the meeting can ask questions, and we can answer 20 them. The purpose of this meeting is to have a 21 dialogue about this topic. And that's basically 22 the ground rules.
23 I'll show you how to communicate with 24 us real briefly. I'm going to slide the Teams 25
5 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com screen on to my desktop for a second, and at the 1
top of your screen, you should see some icons. If 2
you hit the raise hand icon, that will give us the 3
ability to know that somebody has a question. All 4
right? And we'll be able to either hold for that 5
- question, or we'll engage if we have the 6
opportunity to do that.
7 The other way that you can communicate 8
with us is to add a message into the chatbox. The 9
chatbox is available for communication, but right 10 now, I may or may not see that question come in.
11 We're going to try to get through the 12 presentation materials -- and I should say that, in 13 order for you to ask a question, you're going to 14 have to unmute yourself. I've muted everybody 15 except for myself. There's a mute microphone 16 button here. You'll have to unmute it, or I can 17 unmute it. If you raise your hand, I can unmute 18 you as well.
19 All right, that's the ground rules.
20 We're going to have a conversation. We're going to 21 share information with you. You can ask us 22 questions back by either raising your hand or 23 adding a question into the comment box.
24 And one last
- thing, a
mechanistic 25
6 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com thing: I want to just show everybody how to get to 1
this public meeting and get this slide presentation 2
that's visible to you if you don't have access to 3
it right now. You just go to the main NRC website, 4
www.nrc.gov. There's a public meeting section on 5
the right side of the page, and if you go to 6
today's date on the calendar, February 7th, click 7
on that.
8 It will show you each of the public 9
meetings that are being hosted today at the NRC, 10 and if you scroll down to the third meeting right 11 now, you'll see the fitness for duty meeting, which 12 is the meeting that we're in right now. If you 13 click on the more button there, you'll be able to 14 go to the bottom and pull up the slide deck, the 15 meeting notice.
16 And then, at the conclusion of this 17 meeting, we will provide a summary of the meeting, 18 and we're also providing a transcript of the 19 meeting, so those will be posted within one month 20 of this public meeting. So, this is a good 21 resource for you to find these documents. They're 22 publicly available.
23 All right. Last housekeeping measure.
24 Let me admit a few more folks to the call. Good 25
7 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com morning, good afternoon. We're just starting, just 1
going through some of the ground rules. Welcome.
2 All right. Today's discussion topics, 3
there are a number of them. I just talked about 4
the remarks, opening remarks. I introduced who I 5
am. Stew will talk in a minute. I'll go through 6
the agenda for the meeting today, and then we'll 7
get into the basics of what we want to talk about.
8 We're going to give some background on 9
the rulemaking process -- we're at the very, very 10 start of the rulemaking process right now -- and 11 then I'll go through some key topic areas for 12 discussion. These are some key areas that we 13 believe, as a staff, are driving us to seek 14 permission from the Commission to move forward with 15 a rulemaking.
16 And that's where we are right now.
17 We're in the development stage of the next 18 rulemaking. We're developing a plan that we want 19 to submit to the Commission and receive their 20 approval to move forward with rulemaking. Stew 21 will talk about that more in a minute.
22 Okay. And then we have a question-and-23 answer session. Now, this could go two ways, and I 24 sort of alluded to this before. We can either take 25
8 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com questions as we go through the slides, or we can 1
wait and take some breaks, have people chime in.
2 There's a lot of content in here, so I think maybe 3
we can break after a slide or two, and then see if 4
folks have questions.
5 Of course, we want to try to get 6
through all the material and give folks an 7
opportunity to offer up information that they may 8
have that we're not talking about in our slides.
9 That's -- one of the main purposes of this meeting 10 is to solicit input, right? So, if there are key 11 topic areas that you think are not covered in these 12 slides, please feel free to offer that information 13 to us. That's the exact purpose of this meeting.
14 Okay.
The agenda is to make 15 introductions. Now, of course, we're a couple of 16 minutes behind, but that's because I started the 17 meeting a little late to make sure everybody 18 joined. So, we're going to do the introductions, 19 which we've already done.
20 I want to stop in a second and make 21 sure that I have an introduction from Stew and if 22 anybody else wants to introduce themselves. I'm 23 not going to go through introductions for everybody 24
-- we have 74 people on the call -- but I believe 25
9 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com NEI is on the call. Johnny, if you havent spoken, 1
you probably want to introduce yourself at some 2
point, too. So give me one second, and we can do 3
that.
4 Background information: we're going to 5
talk through the key topics. About an hour, we 6
believe, we'll take for that, but if we're engaging 7
throughout, we can fill up the whole two-hour 8
conversation with that.
9 And the more engagement we have, the 10 better. That's exactly what we want from this.
11 This is the opportunity that the public has, the 12 industry has, to talk to us right now, when we're 13 formulating key topic areas that we want to receive 14 permission to move forward with in rulemaking.
15 And then we'll have the QA session.
16 And we budgeted an hour of this two-hour meeting 17 for that, but that'll depend on the conversations 18 we have through the slides. And then we'll close 19 by 3:00 today.
20 Okay, so, that's the agenda. Let's do 21 some introductions. Stew, can you introduce 22 yourself? And then, Johnny, if you'd like to 23 introduce yourself, that would be great.
24 MR. SCHNEIDER: Yes. I'm Stewart 25
10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Schneider. I'm a Senior Rulemaking Project Manager 1
in the Office of NMSS, Nuclear Materials Safety 2
Safeguards. And I've been at the agency for 32 3
years, and I've worked with Brian for over a decade 4
on fitness for duty drug testing and alcohol 5
requirement rulemakings.
6 MR. ZALESKI: Thanks, Stew. Johnny, 7
would you like to introduce yourself?
8 MR. ROGERS: Good afternoon, everybody.
9 Johnny Rogers, Senior Project Manager with NEI, 10 focusing on, of course, fitness for duty and access 11 issues.
12 Really pleased to be here, and glad to 13 be in a place where we're talking about this 14 important development of rulemaking, and really 15 appreciate Brian putting the meeting together. So, 16 I look forward to a good discussion, and thank you, 17 Brian. Back to you.
18 MR. ZALESKI: And then, finally, I do 19 want to acknowledge -- this is an important 20 acknowledgment for me. Paul Harris, my colleague 21 for many years at the NRC, I think, in total with 22 his military service in the Navy and then also 23 working at NRC, had over 40 years of public 24 service. He retired several weeks ago, and I want 25
11 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com to acknowledge that.
1 He'll be missed. I'll miss him. I 2
know many in the industry will miss him. He's been 3
with us for quite a long time, and I just want to 4
say thank you, Paul. I'm not sure if he's on the 5
call or not, but I wanted to acknowledge my 6
colleague, and I hope he enjoys his retirement.
7 Well-earned, and he's been a great contributor to 8
public health and safety.
9 All right. Did we get everybody on 10 here? Yes, we did. Okay. All right, so, let's 11 go.
12 Stew, you're up. If you could give us 13 some information about the rulemaking process, that 14 would be great.
15 MR. SCHNEIDER: Well, thank you. Good 16 day again. I'm Stewart Schneider, the rulemaking 17 project manager for this rulemaking activity. And 18 as Brian has already mentioned, the title of this 19 rulemaking activity is Drug and Alcohol Testing:
20 Technical Issues and Editorial Changes.
21 There are two tracking numbers 22 associated with this rulemaking activity, as shown 23 on this slide. One of the numbers is the NRC docket 24 number, which is on regulations.gov, which is where 25
12 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com the NRC staff will post the public documents 1
related to this activity. It's also where the 2
public can submit comments on the regulatory basis 3
and proposed rule in the future. Again, the 4
assigned docket number for this rulemaking is 5
6 The second number is the rulemaking 7
identification number, also known as the RIN, which 8
for this activity is 3150-AJ15. The RIN number is 9
displayed on every rulemaking document related to 10 the rulemaking that is published in the Federal 11 Register.
12 So, again, those are the two numbers 13 that the public should use to track this activity, 14 and now I'll briefly explain the process that the 15 NRC staff will follow to conduct this rulemaking 16 activity.
17 The first phase is the rulemaking plan.
18 That's where we are now. We're currently in the 19 process, Brian and I, of developing the rulemaking 20 plan. When completed, the plan will be transmitted 21 to the Commission for review and approval, and the 22 staff expects to transmit that plan to the 23 Commission by late spring of this year.
24 Additionally, the rulemaking plan is a public 25
13 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com document.
1 The second phase is the development of 2
the regulatory basis and its issuance for public 3
comment. Please note that the Commission must 4
approve the rulemaking plan before we can start 5
working to develop the regulatory basis.
6 Together, these two stages, known as 7
the rulemaking plan and regulatory basis, are 8
collectively referred to as the pre-rulemaking 9
phases. The start of the rulemaking occurs at the 10 proposed rule phase, as you see in the third line 11 there.
12 The third phase is initiated with the 13 publication of the regulatory basis. After the 14 staff develops the proposed rule and it's approved 15 by the Commission, it will be issued for public 16 comment.
17 The fourth and final phase is the 18 development and issuance of the final rule. And 19 during that phase, the staff will respond to public 20 comments on the proposed rule and then revise the 21 rule as appropriate. It's important to note that, 22 during each of the four phases, a public meeting is 23 held to inform the development of this rulemaking, 24 and today's meeting is to help inform the 25
14 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com rulemaking plan.
1 Also note that on this slide, we've 2
provided the public with two web links. The first 3
link is to the NRC planned rulemaking activities 4
website where the public can find general 5
information and schedule. With respect to the 6
second link, that will take you to regulations.gov, 7
again, which is where the NRC docket is for all the 8
documents that we put up that are made public.
9 What you will also find there is the 10 comments come in, and we process them on the reg 11 basis on the proposed rule. We will post them to 12 regulations.gov.
13 MR. ZALESKI: And really, Stew, that's 14 a
collective for anything that we generate 15 officially for the rulemaking.
So, public 16
- comments, any documents associated with the 17 rulemaking --
18 MR. SCHNEIDER: Today's meeting slides, 19 the summary, the transcript, all of those documents 20 will be put up there.
21 MR. ZALESKI: Right, in addition to 22 being available on the NRC public website. Just to 23 be clear.
24 MR. SCHNEIDER: Yes. The public 25
15 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com website for ADAMS. If it's in ADAMS, it will be up 1
on regulations.gov.
2 So, let's go to the next slide.
3 Basically, what I'm showing you here is this is the 4
overall NRC rulemaking process. Right now, again, 5
we're in the pre-rulemaking stage. We're right 6
between the gray area, gray-blue, on the pre.
7 MR.
ZALESKI:
Yes.
I'm just 8
highlighting it, there's a box around it so people 9
can see on this image where we are. We're right at 10 the very top, 12:00, you know, in the orientation 11 of this.
12 MR. SCHNEIDER: Yes, exactly.
13 MR. ZALESKI: Okay.
14 MR. SCHNEIDER: And then, once we're 15 approved by the Commission to develop the 16 regulatory basis, as I already stated, and complete 17 the regulatory basis and issue it, we then go into 18 the rulemaking
- process, which is the lower 19 diagonal, below the diagonal.
20 MR. ZALESKI: Right down here, right.
21 So, to emphasize again to everybody on 22 this call, we're talking about various stages of 23 rulemaking, and Stew just spoke about that. But 24 where we are right now is in the pre-rulemaking 25
16 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com stage, and we are seeking to initiate rulemaking 1
activities and asking the Commission for approval 2
to do so.
3 We have not received approval from the 4
Commission to move forward with rulemaking, but 5
that is the intent of the staff: to initiate this 6
activity through a plan that we're going to send to 7
the Commission later in the spring, as Stew said.
8 MR. SCHNEIDER: Correct. And that 9
wraps up this portion of the process.
10 MR. ZALESKI: Great. And I should say 11 something about housekeeping measures.
12 The slide deck today, the way we built 13 this slide deck, we tried to make it a resource --
14 like, a general platform for all the information 15 we're going to discuss -- so the links that you saw 16 in the previous page, those links work. You can 17 see -- I don't know if it's visible. You can see 18 that the web address is there. If you click on it, 19 that will pull up the web address. So, all the 20 links work.
21 So, every document in here, if you want 22 to download all the documents for your resources to 23 start going for this rulemaking, everything in this 24 document should work for you to do so.
25
17 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. SCHNEIDER: Yes. The one thing 1
that I just noticed when Brian clicked on that link 2
for the information and schedule website, it brings 3
up our entire suite of rulemakings that we're 4
working on. You would then go down to the one 5
that's specific to this rulemaking, but by clicking 6
on that, you can follow any of the rulemakings that 7
we're currently working on, which, again, the 8
Commission has approved the staff to spend 9
resources on.
10 MR. ZALESKI: Right, and this is a good 11 place to find dates and things like that. Right.
12 MR. SCHNEIDER: Yes.
13 MR. ZALESKI: So, anyway, we want to 14 just provide you with the tools the agency offers 15 up to the public for transparency purposes. There 16 are a variety of ways for you to access material, 17 which is great. I think NRC does -- I'm biased 18 obviously, but I think NRC does a fantastic job of 19 putting out our documents to the public and always 20 has been that way.
21 Okay. Anything else you want to cover, 22 or is it time for me to start moving through?
23 MR. SCHNEIDER: Just simply, again, to 24 understand that when the rulemaking plan is 25
18 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com provided to the Commission, shortly thereafter, it 1
will be made public. And you will be able to see 2
it while the Commission is reviewing it and 3
deciding on this path forward.
4 MR. ZALESKI: Right. So, the inputs of 5
the meeting today. Obviously, the staff is 6
developing this plan. We're seeking input from the 7
- public, members of the public; stakeholders 8
obviously, members that work at power plants, 9
industry stakeholders; anybody calling in from 10 laboratories, substance abuse experts and medical 11 review officers. We have a diverse group of people 12 that support the FFD program, and all of the input 13 is greatly appreciated and welcomed.
14 MR. SCHNEIDER: Thank you.
15 MR. ZALESKI: Thank you, Stew. All 16 right, so, some folks might be scratching their 17 heads
- saying, wow, we just finished with a
18 rulemaking, right? And many of the people that 19 have called in here are practitioners of Part 26, 20 and they just implemented our final rule published 21 in 2022.
22 And it was required -- all licensees be 23 in compliance by November 22nd, 2023, so a one-year 24 compliance period. So, I believe that most of the 25
19 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com industry implemented the rule in the last quarter 1
of the year, in the October and November --
2 obviously by November 22nd, but in October to 3
November time frame. We had one or two utilities 4
implement earlier in the summer.
5 So, that rule is now in place.
6 Congratulations, and I want to take an opportunity 7
to thank you all for all the hard work to get the 8
rule in place and all the feedback and productive 9
communication we had to make that rulemaking, I 10 think, a success. And hopefully, we'll use the 11 same tools and engage in the same way to make sure 12 that this rulemaking effort is also a success.
13 Sorry. I'm just accepting folks to the 14 meeting.
15 A part of the rulemaking process is we 16 communicate. The staff communicates with the 17 Commission through what's called a SECY. It's like 18 a memorandum that we issue or we produce and we 19 provide to the Commission. And there was a SECY 20 developed that we sent with the draft final rule 21 that was just finalized in 2022, and it addressed 22 this next rulemaking, this tech issues rulemaking.
23 And that's what the second bullet on 24 this slide means. It was basically acknowledging 25
20 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com that -- well, the first and the second bullets --
1 that we were going to move forward as a staff with 2
another rulemaking that's been on the books for 3
quite a while, but that we were holding back on 4
until we completed the initial rulemaking, the HHS 5
guidelines rulemaking. And our intention was to do 6
that within one year of implementing the 2022 final 7
rule.
8 We sought a little bit more time, and 9
that was primarily because we were engaged very 10 heavily in implementation activities. We asked for 11 a little bit more time so that everybody could 12 collectively be focused on implementing the rule 13 that we just finished.
14 Part of that memo, we had a statement 15 in there that said we expect to consider utilizing 16 oral fluid testing under additional testing 17 conditions in the future. Okay? That was one key 18 element of the 2022 final rule that was new.
19 Prior to that
- time, we did not 20 authorize the use of oral fluid testing except 21 under very limited medical conditions or 22 circumstances. For example, a person could not 23 produce a urine specimen. Their body did not 24 produce urine. They were in end-stage renal 25
21 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com failure. So if they couldn't produce urine, the 1
rule afforded the medical review officer a
2 methodology to seek testing under another method, 3
oral fluid, whatever.
4 So, this rulemaking in 2022 allowed the 5
use of oral fluid testing for a limited set of 6
circumstances, and that was related to observed 7
collections. And so, this next rulemaking, we 8
would like to explore expanding the use of oral 9
fluid testing, and I'll explain why in a minute.
10 But that's one of the core reasons why we want to 11 move forward with rulemaking at this time. Oral 12 fluid testing: we want to expand the use of that 13 tool. It's going to be very effective, we believe, 14 in reducing the ability to subvert the drug 15 testing, the urine drug testing process.
16 Okay. And the last reference here is 17 just the rulemaking. If you want to pull up the 18 final rule, it's linked right there on this slide.
19 Okay. So, why are we doing this 20 rulemaking? There are really three core reasons 21 why we want to do this rulemaking. One is, and I 22 think it's always the case with rulemaking, we want 23 to improve the effectiveness and efficiency of what 24 we're doing.
25
22 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com So, we want to improve the 1
effectiveness and the efficiency of Part 26, and we 2
do so in a variety of ways. One way is we look at 3
federal partner agencies, and there are two that we 4
primarily look at.
5 Health and Human Services. They are 6
the authors and the scientists behind the 7
guidelines which dictate the certification process 8
for laboratories that we require licensees to use, 9
but they also are the scientists behind identifying 10 how to test for these drugs, how to be sure that 11 the drugs that we're testing for are consistently 12 identified, so the standardization of that process.
13 And they also monitor drug use trends, what 14 substances are prevalently available in society 15 that can challenge regulated testing.
16 And primarily, the individuals that 17 will be subject to testing by the federal 18 government are going to be in safety-or security-19 related positions and federal workers. I'm tested, 20 Stew is tested, because I'm a federal worker. And 21 then, DOT tests people because it's transit, right?
22 Airline pilots, bus drivers, et cetera. And then, 23 in the nuclear industry, we test to ensure that 24 everybody that's working in a nuclear power plant 25
23 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com or a Category 1 fuel fabrication facility, is safe 1
and secure.
2 The second topic area of this 3
rulemaking is to incorporate lessons learned. Now, 4
part of the 2022 rulemaking final rule did include 5
some lessons learned, but they were fairly limited 6
in scope. This is one of the primary reasons we're 7
doing this rulemaking.
8 Part 26, the original
- rule, was 9
effective in 1990. There was one major upgrade to 10 the rule in 2008, and then we had a final rule in 11 2022. There were some minor rulemakings in the 12 interim, but not very significant in terms of 13 process changes.
14 So, we have a lot of lessons learned.
15 We have a lot of runtime on the 2008 rule, 15 to 16 16 years at this point. We don't really have any 17 runtime on the 2022 final rule, but it was a 18 limited scope rulemaking, and it was targeted to 19 changes in the drugs that we're testing for, so 20 we'll have additional positives, we believe. But 21 beyond the scope of that, there weren't many 22 changes in the rule associated with lessons 23 learned.
24 Petitions for rulemaking. So, the 25
24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com public can solicit or ask the agency to consider 1
changes to a rule by submitting a request for a 2
petition for rulemaking. And we've received three 3
over the years, and I'll go into a little bit of 4
detail on each of those, but that's another topic 5
area that will be a part of this rulemaking.
6 So, the objectives are to incorporate 7
effectiveness and efficiency improvements by 8
aligning with federal partner testing programs; 9
lessons learned, and there are many, and most of 10 the practitioners on the call can offer those up; 11 and then we have these petitions.
12 Okay. Next slide. Okay. A federal 13 partner that we look closely at is the Department 14 of Transportation. There's a couple of reasons for 15 that. One of the reasons is that NRC and DOT 16 implemented their rules at the same time, roughly 17 the same time. 1989, we issued final rules, and so 18 we're partners in that process.
19 DOT wants to make sure the public is 20 safe when they're in vehicles, airplanes, et 21 cetera. That protection is similar to what we 22 have, right? We want people to be safe that are 23 operating power plants, safe and secure, so we have 24 a similar scope of responsibility. We want to make 25
25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com sure that individuals are not impaired from 1
substances, and therefore, we watch what other 2
agencies are doing and we learn from what other 3
agencies are doing.
4 The Department of Transportation is a 5
very, very large-scope agency. They test five to 6
six million people a year, so that's a large, 7
regulated workforce. Last year, I think we had 8
110,000 or 115,000 total tests under Part 26. So, 9
in the larger scheme of things, if things are going 10 to happen, you're going to see some more things 11 happening in DOT world because they test six 12 million people. So, they're a great federal 13 partner, and we can learn a lot from what they do.
14 One of the things that I think is going 15 to be helpful to us in consideration as we move 16 forward with rulemaking is to consider some changes 17 that DOT made in 2017. So, the slide that you see 18 in front of you is a reference to one section 19 within a final rule that was issued in 2017 by the 20 U.S. Department of Transportation. It was issued 21 primarily to add semi-synthetic opioids, so that's 22 the addition of certain Schedule II drugs. They 23 expanded their drug-testing panel to include semi-24 synthetic opioids. These are the ones we just 25
26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com added in 2022, so they did that back in 2017.
1 That rule was effective in 2018. One 2
key element that they had in that rule addressed 3
prescription drugs, so I think that's a key area 4
where we really need to add some clarity in our 5
rules and have some structure, too.
6 We do not, for example, define what a 7
legally-valid prescription is. We do not define 8
what a legitimate medical explanation is. And I'll 9
talk more about those later, but this is the 10 statement, and this is a piece of the policy 11 implemented in the final rule back in 2017 by DOT 12 that I think we can benefit from.
13 They talk about what a legally-valid 14 prescription is, and it's consistent with the 15 Controlled Substances Act.
The Controlled 16 Substances Act, that should ring a bell because the 17 Controlled Substances Act is where things are 18 scheduled: Schedule I drugs, Schedule II drugs, et 19 cetera. So, it's tying those substances that are 20 prescribed, legally-valid prescriptions, to the 21 Controlled Substances Act.
22 Why is that important? It's important 23 because people can take medicines that are 24 perfectly legitimate to take, there's a medical 25
27 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com reason for it, and they will test positive -- for 1
example, an ADHD medication. An individual could 2
take an amphetamine. They have a legitimate 3
medical use for that. They're under the care of a 4
physician. They have attention deficit disorder, 5
so they're going to test positive for amphetamines.
6 And the medical review officer is going to talk to 7
them about it, and they're going to ask them about 8
that medicine, and they're going to confirm that 9
they're under the care of a treating professional.
10 They have a legitimate use for that medicine. They 11 have a prescription that's valid. It's not an 12 illicit use of a medication.
13 So, that's one of the pieces. There 14 are others, but what we're trying to do here is 15 highlight key pieces that we think are going to be 16 beneficial to us and why we should move forward 17 with rulemaking now.
18 Okay. Another rulemaking that the 19 Department of Transportation issued was in 2023.
20 They issued this final rule after our November 2022 21 Part 26 final rule. And this is the first time 22 that the Department of Transportation has approved 23 the use of another substance besides urine for drug 24 testing.
25
28 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com So, in May 2023 they issued an Addition 1
of Oral Fluid Specimen Testing for Drugs final 2
rule. It's important. It's a new authorization 3
for the Department of Transportation for their 4
stakeholders, their regulated industries, to 5
collect urine for drug testing or, in fact, collect 6
oral fluid for drug testing.
7 So, both -- the NRC has authorized 8
collecting of oral fluid in limited circumstances.
9 This is a broader-scope rule authorizing the 10 testing of oral fluid in different test conditions, 11 so this is one of the areas we want to move to. We 12 believe that expanding oral fluid testing to 13 different testing conditions, not just under 14 observation conditions, as we authorized in the 15 2022 final rule, is going to be very beneficial to 16 us. So this is a good model for us to look at and 17 to evaluate what they've done.
18 Now, what I will say is that no 19 regulated entity in the United States, either at 20 the federal level, from the federal workplace drug 21 testing program -- you know, federal employees, 22 U.S. NRC or anybody else that works in the 23 government, or the Department of Transportation --
24 is conducting oral fluid testing at this time. And 25
29 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com the reason being is we've yet to have any 1
laboratory certified by HHS to test oral fluid.
2 And, in fact -- and this is the last 3
element within this slide -- DOT is requiring that 4
two HHS-certified laboratories be available for 5
testing prior to any of the regulated entities 6
being able to use oral fluid. And why is that?
7 Because you need a second laboratory to do re-8 testing, right?
9 It's a donor protection. You have an 10 initial laboratory. It can verify a positive 11 result. The donor has the ability to request a re-12 test. If there is not a second laboratory 13 available to do that testing, there's no ability to 14 validate that test result. There's no donor 15 protection in place. Therefore, we can't move 16 forward. And so, that's where DOT is right now.
17 Okay. And there's no order to these in 18 terms of the federal agencies. They're equally 19 important for a variety of reasons. So, HHS, as I 20 spoke about a little bit ago, they're, by statute, 21 in the United States, mandated with developing the 22 testing panel, researching the drugs, establishing 23 the criteria to certify HHS laboratories to conduct 24 testing for the federal workplace, and also 25
30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com inspecting those laboratories. So, there's a 1
reason why we rely upon HHS at the NRC and at the 2
DOT.
3 So, mechanistically, the Department of 4
Transportation is required -- under law, under a 5
congressional act, to implement the HHS drug 6
testing panel changes. When HHS issues them, DOT 7
must. The NRC does not have a tie to changes to 8
the HHS guidelines, and that's an important thing 9
to keep mindful of.
10 We don't have a trigger law, per se, 11 that says, okay, NRC, if HHS changes their testing 12 panel or changes the cutoff levels, you must move 13 forward. The DOT has that. And so, that's one 14 difference between the NRC and DOT and why we may 15 not move forward with rulemaking as quickly as the 16 DOT. DOT is required to do that.
17 In
- 2023, HHS came out with two 18 guideline revisions. In 2019, they issued oral 19 fluid testing guidelines for the first time. Prior 20 to that, urine was the only specimen that was 21 authorized for testing in the federal workplace 22 and, as I said, DOT as well, and the NRC world as 23 well, except under very, very limited medical 24 circumstances.
25
31 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com In 2019, HHS issued final oral fluid 1
guidelines. We relied on those guidelines to 2
enable our licensees to use oral fluid testing 3
under the circumstances of observed collections, 4
and that is the trigger to enable DOT to move 5
forward as well -- the HHS-issued guidelines. HHS 6
will certify laboratories. DOT entities can, 7
therefore, use oral fluid.
8 DOT is not requiring their licensees --
9 I'm sorry. DOT is not requiring the use of oral 10 fluid. It's an option, and that should be clear.
11 In the federal workplace, HHS is not mandating 12 federal agencies use oral fluid. I think it's 13 optional.
14 So, why is 2023 important? The 2023 15 guidelines are important for two reasons. One, the 16 main reason that they're important is they changed 17 the process to update their testing panels.
18 So, in the past, HHS would issue 19 guideline changes maybe every five to six years 20 with tweaks to the testing panel. However, drug 21 use trends change in the United States, and they 22 may change much quicker than five or six or seven 23 years.
And that's not the most protective 24 environment for public health and safety, to be 25
32 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com chasing a drug use trend in society and being late 1
to the party, per se.
2 The opioid crisis is a primary example 3
of that. That's been going on for quite a long 4
time before the federal agencies were able to 5
establish changes in the programs to test for these 6
substances.
7 In the 2023 guidelines, HHS established 8
an annual review process to look at their panel, to 9
look at their cutoff levels, and change it if drug 10 use trends support that change. So, this is a 11 major paradigm shift for the federal workplace drug 12 testing. This did not exist prior to 2023. These 13 guidelines were issued in October of 2023, so 14 recently. We'll talk about this later.
15 Of course, as a federal agency, we want 16 to make sure that we are maintaining reasonable 17 assurance that individuals that are working at 18 licensed facilities are safe and secure, they're 19 able to do their job safely and securely. If we 20 have drug use trends that are changing rapidly and 21 HHS is changing their testing panel rapidly, we're 22 going to have to try to evaluate a different 23 approach to keep up with those changes.
24 The gray box here says the tech issues 25
33 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com rulemaking is not intended to address those 1
frequent HHS panel changes, and I'll talk more 2
about that later. We need to go back and we need 3
to look at how we are modifying our rules 4
consistent with this new anticipated more frequent 5
changing of the HHS guidelines, so I wanted to 6
acknowledge that. I wanted to let everybody know 7
about this change, and then we'll circle back at 8
the end of this conversation.
9 Petitions for rulemaking. So, in terms 10 of the schematic or the diagram that Stew had shown 11 us earlier, there are several ways you can move 12 into rulemaking space. One is staff-initiated. We 13 identify issues that we believe are appropriate for 14 rulemaking, and we convince the Commission that 15 it's appropriate to move forward.
16 So, there's clearly going to be a part 17 of this rulemaking that is staff initiated, but the 18 agency also has received input from three different 19 stakeholders requesting changes to our rule. The 20 first is the California Association of Marriage and 21 Family Therapists, and they requested the addition 22 of their organization to the list of acceptable 23 credentials to serve as a substance abuse expert.
24 So, in 26.187, we list the credentials 25
34 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com that you must have to be able to serve as a 1
substance abuse expert.
There's many other 2
elements that are requirements to be a substance 3
abuse expert. One is that you have a particular 4
credential, so this petition seeks to add these 5
family therapists to that list.
6 The second petition is from a
7 certifying organization of substance abuse experts.
8 The American Academy of Health Care Providers in 9
the Addictive Disorders submitted a
petition 10 requesting that they be approved as an acceptable 11 certification organization for substance abuse 12 experts. And you'll notice links to the relevant 13 sections within our rule. I'm going to click on 14 one so you can see what's pulled up. It should 15 come up here in a second.
16 All these links go to the eCFR, the 17 Electronic Code of Federal Regulations, which is a 18 really nice tool. It's formatted well, it's easy 19 to use, and it's timely. The NRC has its own 20 website, but I would offer that this eCFR website 21 is formatted better and it's easier to use. So, 22 all these links work, so you can go back and take a 23 look later.
24 The third petition for rulemaking is 25
35 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com titled Additional Synthetic Drug Testing under FFD 1
Programs. An individual requested that the agency 2
expand the panel of drugs to include additional 3
substances. Some of them actually we addressed in 4
the 2022 final rule. We added four semi-synthetic 5
opioids -- hydromorphone, hydrocodone, oxycodone, 6
oxymorphone -- but that petition was broader. You 7
know, it said, look, there's all these synthetic 8
drugs out there folks are using.
They're 9
impairing. You need to really broaden your scope.
10 So, of course, we're going to evaluate 11 that petition because we're a fitness for duty 12 rule, and it's part of this request to the 13 Commission in our rulemaking plan.
14 The link at the bottom of this slide is 15 where you can identify these petitions if you want 16 to read them. Actually, the link in the Federal 17 Register is the NRC acceptance of this petition for 18 rulemaking. All of these petitions, the actual 19 letters from these individuals or these 20 organizations, are also on the docket at 21 regulations.gov, and that's how you can track them 22 down if you want to read about them. They're all 23 pretty short statements.
24 Let me stop for a second. So, we've 25
36 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com talked about a
couple of federal partner 1
regulations or guidelines that we want to take into 2
consideration, a couple of nuggets that we believe 3
are compelling and worth incorporating in our plan 4
-- although, clearly, there are others in the HHS 5
guidelines and in the DOT's 2017 to 2023 6
rulemakings and then the petitions for 7
rulemaking.
8 Any questions on that, before we move 9
forward with the lessons learned element of the 10 meeting? Okay. Thanks for the breather.
11 All right. So, what are lessons 12 learned? Lessons learned are really anything that 13 we have learned in implementing this rule, and the 14 NRC has had Part 26 on the books since 1990. I'm 15 not sure there's anybody on the call that's still 16 involved since the beginning of 1990, when the 17 program became effective. Maybe there are a few.
18 I know I've been involved in the NRC 19 regulations, both -- as a consultant, before I came 20 to the NRC, I supported the 2005 proposed and the 21 2008 final Part 26 rules. I was actively involved 22 as a technical expert to the agency, and then, I've 23 been with the NRC since 2015. But I bring to the 24 table -- I supported the U.S. Department of 25
37 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Transportations Federal Transit Administration 1
drug testing program, as a consultant way back in 2
2000. So, I bring to the table 24 years of 3
experience, and I know that many of the people on 4
this call bring a large background of knowledge and 5
experience that is beneficial to our program.
6 And also, welcome to a lot of new folks 7
that have joined in the last couple of years.
8 You're experts on your testing program at your 9
site. You just implemented a final rule, and you 10 have valuable feedback to provide to us.
11 So, lessons learned topics, what are we 12 looking at? Questions received from Part 26 13 regulated entities, right? We get questions all 14 the time -- conferences, phone calls, emails. I 15 can think of no time where I received a question 16 where it wasn't valuable to me to understand an 17 issue that was out there that wasn't on my radar, 18 or that a requirement wasn't clear, or just help 19 educate me how a licensee implements. So, all 20 questions are good questions, and I encourage you 21 to do that. I think we all benefit from that, and 22 clearly, this rulemaking is going to greatly 23 benefit from that.
24 Second is site-specific FFD program 25
38 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com performance information.
So, that's been a
1 requirement since the Part 26 rule has been in 2
place. From 1990 to 2008, licensees submitted drug 3
and alcohol testing reports -- summary reports on 4
drug and alcohol testing information to the NRC.
5 From 1990 to 2008, it was every six months. From 6
2008 to the present, it's once a year.
7 And we collect key information about 8
the effectiveness of your program. The types of 9
drugs you're testing, that you're identifying in 10 the population that's either seeking employment or 11 is employed at your sites. Trends -- you know, 12 what types of drugs? Is alcohol the most prevalent 13 substance used? Who is using, so the labor 14 category of an individual. You know, are they a 15 licensed operator? Are they site security? Are 16 they a general maintenance worker?
17 We collect a
lot of different 18 information to help us understand, is our program 19 working? Where are there threats? And when I say 20 "threats," I mean somebody is impaired. Somebody 21 is using a substance that's impairing, and clearly, 22 that's not a good thing. We want to mitigate that 23 risk as best we can with our program.
24 The third item that we consider is NRC 25
39 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com inspection. Every FFD program is inspected once 1
every three years. We have trained regional 2
inspectors that inspect each FFD program in the 3
United States, and that's the front line. They're 4
evaluating compliance every three years. We 5
evaluate effectiveness of your program every year 6
by collecting data. We also get other information, 7
24-hour event reports and 30-day event reports.
8 We'll talk about those
- later, but that's 9
information we use to understand what's going on 10 with the program.
11 NRC fitness for duty technical staff-12 identified issues. So, that was, until a couple of 13 weeks ago, Paul Harris and me, and now it's me.
14 And before that, we've had other staff members.
15 So, all the input that we received from 16 regulated
- entities, and inspections, and our 17 practice of regulating and implementing the rule, 18 we developed items that we thought were appropriate 19 for consideration. And that comes from us engaging 20 other federal workplace drug testing programs, our 21 own technical expertise, and engaging with the 22 public and NRC inspectors.
23 And
- then, finally, some additional 24 input. We received a lot of great input on the 25
40 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com last Part 26 rulemaking. In 2019, we had the 1
proposed rule issued. We solicited input from the 2
public on our proposed changes to the requirements.
3 We received a number of comments that were out of 4
scope.
5 What does out of scope mean? It means 6
that people were commenting on things that we did 7
not propose a change to. So, by law, we can't 8
incorporate changes into our rule unless they're 9
within scope. But we did receive a number of 10 really good comments that we believe are 11 appropriate for consideration. So that's another 12 piece of this, and we'll talk about that later.
13 All those comments were addressed in a 14 comment response document. And it's linked, and 15 you can read all the comments, you know, a summary 16 of the comments, and you can read our responses.
17 So, that's really valuable information, and it's 18 timely information, which is important.
19 So, we have timely information from our 20 last rulemaking. We have a lot of people that have 21 been digging into our rule and modifying policies 22 and procedures recently, so I think this is a great 23 opportunity for us to move forward now and make our 24 rule even better.
25
41 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Oral fluid drug testing. This is the 1
first lesson learned. What's driving oral fluid 2
testing?
3 So, until recently, we didn't have a 4
way of testing oral fluid uniformly.
The 5
government is very, very protective of individuals, 6
right? We want to make sure that if we get a test 7
result, it's an accurate test result and it's 8
consistent over time. And so, that's why we use 9
HHS-certified laboratories who have measured the 10
- science, you
- know, evaluated the science; 11 established the standards; ensured that a test 12 result is valid and repeatable;
- and, if an 13 individual tests positive for a drug, they, in 14 fact, had that in their body. Right? So, that's 15 extremely important.
16 Until 2019, we didn't have another tool 17 that was certified by HHS to proceed. But we did, 18 in the 2022 final rule, get the opportunity to add 19 oral fluid testing for the limited circumstances I 20 already talked about, observed collections. And 21 the reason why we were able to do that was in that 22 rule, we asked, are there any other alternative 23 methods to collecting a urine specimen under direct 24 observation?
25
42 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com So, there are limited circumstances 1
where an individual is asked -- everything we do is 2
voluntary. You can refuse the test, and there are 3
consequences of that. But if there's a reason to 4
believe an individual is attempting to subvert a 5
drug test, cheat, there are conditions where we 6
would ask an individual to remove their clothing 7
from their waist to the knees and provide a urine 8
specimen directly into the cup, and the collector 9
would observe that. And in the 2022 final rule, we 10 allowed oral fluid collections for most of those 11 conditions. Optional; licensees don't have to 12 change anything. They can continue to use urine, 13 but they have the option.
14 We have the same issue that DOT has.
15 There are no HHS-certified laboratories, and that's 16 a requirement. If you're going to conduct oral 17 fluid testing, you need to have an HHS-certified 18 lab to do the testing, and you also need to have 19 the ability to do a re-test of that specimen at 20 another lab. So, we're in the same boat as DOT 21 right now. Even though our rule is in place, it's 22 effective, and licensees may have already adjusted 23 their policies and procedures to accommodate oral 24 fluid testing under those conditions, they still 25
43 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com can't do it. Hopefully, soon enough.
1 What's the big driver for this? You 2
know, there's a variety of reasons where collecting 3
oral fluid is beneficial, just from a collection 4
perspective. But independent of that, the most 5
significant trend, in my mind, that we have and 6
we've continued to have for quite some time, is 7
subversion attempts.
8 So, that's willful misconduct. That's 9
an individual who is attempting to beat the drug 10 testing program. They're trying to either offer up 11 the specimen that is not theirs, it's synthetic 12 urine, or they're trying to impact the ability of 13 the tests to work effectively and disguise the use 14 of drugs.
15 So, when somebody is successful in 16 subverting the drug testing process, that means 17 that an individual who is using an impairing 18 substance that's prohibited for use in our 19 workforce is now employed and working for a nuclear 20 utility in a nuclear power plant. That just is not 21 a good situation for us.
22 Of course, we have defense-in-depth to 23 identify events if someone does get granted 24 unescorted access. But where we want to be is we 25
44 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com want to be able to have a system that's so 1
effective that people don't have the ability to 2
cheat, right? They know that they're going to get 3
caught, and they're not even going to try. That's 4
the most effective system out there.
5 We know that because of the amount of 6
subversions that we identify every year. And this 7
is a key one: 30 percent of the drug testing 8
violations annually -- and this is since, I don't 9
know, 2010, '11, '12 time frame, roughly -- that 10 percentage of the drug testing violations each year 11 under the Part 26 program have been cheating 12 events. Very substantial. It was one of the 13 drivers of our last rule as well. So, oral fluid 14 testing, where you're collecting a swab in front of 15 the collector, and not going into a restroom and 16 closing the door and providing your urine specimen, 17 it could be very, very beneficial in being able to 18 defeat or deter people from subverting.
19 So, that's one of the key reasons why 20 we would want to consider that, but there are other 21 reasons. In some ways, it's easier to collect an 22 oral fluid specimen. The process is simpler, the 23 training is less, it's observed, and that may also 24 be beneficial in what's called a shy bladder.
25
45 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Many people are unable to produce a 1
specimen immediately on being called into the 2
collection site. Maybe they just went to the 3
bathroom or they didn't drink enough, they didn't 4
hydrate enough, so right now, under any of the 5
federal programs, you have up to three hours to 6
produce a urine specimen.
7 Well, three hours is a lot of time. If 8
we could use oral fluid, an oral fluid collection, 9
in lieu of a urine specimen in that circumstance, 10 you get that person back to work a lot quicker. So 11 there's efficiencies that we may benefit, right, 12 from using oral fluid in that way.
13 So, those are the reasons why we think 14 oral fluid is important, and it's really a
15 cornerstone of this rulemaking. One, subversion 16 attempts.
We think it's going to be very 17 beneficial in deterring subversion of the testing 18 process. But we also think it could improve the 19 collection process, right? Get people back to work 20 quicker, process people in a more timely manner, 21 and utilize time in a better way.
22 All right. Subversion. So, we talked 23 about subversions being significant, 30 percent.
24 And there are slides I present, and I'm just going 25
46 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com to show it real fast so we can have a -- I think 1
every presentation I've made in the last seven or 2
eight years, I provide a slide on subversions. And 3
so, just to provide a little background, so I was 4
talking about every year we see about 30 percent of 5
drug testing violations are coming from subversion 6
attempts.
7 So this is the slide, the last I 8
presented. I think this slide, I presented at the 9
NEI conference in July. All the slides are 10 available publicly.
11 The second line item is the percentage 12 of drug testing violations, right? So, between 30 13 and 35
- percent, roughly, were drug testing 14 violations over the last six years. Not only is 15 that important, but if you look at the numbers, 16 right, 305 individuals were identified subverting 17 in 2017, 268 in 2022. So, that's significant.
18 It's a lot of people.
19 Most of these individual events are 20 identified at pre-access testing, and why is that?
21 Because it's predictable. Everybody knows you're 22 going to get drug tested before they're getting 23 unescorted access to a power plant or to a Cat 1 24 facility. It's predictable. You can plan for it, 25
47 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com and that's why, you know, between 67 and 79 percent 1
of the subversion attempts identified each year are 2
at the pre-access testing phase, testing category.
3 Who is doing it? Almost all the 4
individuals that we identify cheating every year 5
are contractor/vendors.
You
- know, 6
contractor/vendors and licensee employees are two 7
worker populations that we closely monitor, and 8
there are very distinct differences between those 9
worker populations.
10 A lot of the contractor/vendors are 11 short duration individuals. You know, they're 12 providing functions under a limited duration. A 13 lot of them are going to be in outages. We're 14 moving to outage season again. You know, you're 15 going to have an outage for four weeks. You're 16 going to have a lot of contractor/vendors on that 17 site.
18 So, a lot of that is being driven by 19 outages for contractor/vendors, but not always.
20 But most of the people that cheat are contractors 21 or vendors, and probably a very, very important 22 reason why: if you get identified as cheating under 23 Part 26, you have a permanent denial of unescorted 24 access.
25
48 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com So, the deterrent provided is very 1
significant in that sanction. If you're caught 2
cheating, you're permanently denied, right, so I 3
think that's why we see contractor vendors 4
primarily being the ones that are attempting to 5
subvert the process. They're a short duration, 6
they have other jobs they can do, and this is just 7
one job in a slew of jobs they might be able to do.
8 And the last piece, not to belabor the 9
point more, is not only are the subversions 10 significant, right -- the number is high, the 11 percentage is consistent and high year over year --
12 but the last one is that most of the sites are 13 reporting subversion attempts, between 64 and 75 14 percent of the sites each year that report fitness 15 for duty data, and that's all of them, report at 16 least one subversion attempt.
17 So, people are trying to use products 18 across the board. It's been consistent over time.
19 We have to continue to improve our ability to 20 identify use and, preferably, to deter it -- our 21 tools are so good that you're not even going to 22 seek employment, right?
23 So, that's the data there. I just 24 wanted to offer that up. And let's get back to the 25
49 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com slides.
1
- Okay, so, subversion attempts.
I 2
provided you with the training information. What 3
are other things that we think could be beneficial 4
to us? Well, the first one is -- and there's no 5
real order to these either, but they all have 6
priority. Anything in this presentation, we 7
believe, has priority. The first one would be, if 8
you're in possession of subversion paraphernalia 9
and you're on a site, we need to prohibit that.
10 Right now, the products, the subversion 11 process -- or the procedures and requirements are 12 tied to the collection process. So, if you 13 identify somebody that has a heating element, you 14 know, a squeeze bottle with a temperature strip on 15 it and a heating element on it, and it's deemed 16 paraphernalia, and it's in their desk, well, you're 17 going to probably do a for-cause test. I imagine 18 you'd all do a for-cause test, because you have a 19 reason to believe they may be attempting to 20 disguise drug use, right?
21 That's not prohibited. We want to put 22 that in place that it's prohibited. If you're in 23 possession of that product, it's clear what that 24 product is used for.
That's a
prohibited 25
50 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com possession. That's not acceptable to have on you 1
in any shape or form.
2 Why would we want that? There's no 3
legitimate reason for possession of these products, 4
and most importantly, they're illegal in some 5
states. Some states have laws in place that 6
prohibit you from having those products, right?
7 So, not only is -- and our rule is human 8
performance-based, but we also have the trustworthy 9
and reliability elements. If you commit a crime by 10 being in possession of those products, that's a 11 trustworthy and reliability issue.
12 Subversions are willful misconduct.
13 There's no legitimate reason to have these 14 products. We should consider adding a prohibition 15 in our requirements.
16 The second piece: we should institute a 17 permanent denial if you're in possession of the 18 paraphernalia. We have a permanent denial if 19 you're identified subverting the drug testing 20 process during the collection process. We don't 21 have a denial in place if you're in possession of 22 these products independent of the collection 23 process. So, this is an area where we should 24 tighten.
25
51 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Most of the subversion attempts that we 1
identify are in the collection process -- and this 2
is the third bullet -- is from a urine specimen 3
that's out of temperature range. So, we monitor 4
the temperature of a specimen, and if it's out of 5
90 to 100 degrees Fahrenheit, that's reason to 6
believe an individual has done something to their 7
specimen or it's not their specimen. They diluted 8
it. They could add water into their specimen to 9
dilute the concentration of the drug in that 10 specimen below the cutoff level of that drug test 11 or, more times than not, from what we see in our 12 identified subversions, it's a synthetic urine 13 that's out of temperature range.
14 Can we benefit from tightening up that 15 temperature range from 90 to 100? Do we have the 16 ability to do that? I think we do. Most of the 17 licensees or many of the licensees -- I don't have 18 data to say all, but I believe many of our 19 licensees measure temperature independent of the 20 cup.
21 So, the collection container has a 22 temperature strip on the outside of the container, 23 and it lights up. Most of our licensees also use 24 an external measurement device, which is enabled by 25
52 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com our regulation, and they use that to measure 1
temperature. Either it's a thermometer with a 2
sterile sheath that they pull out a piece of paper, 3
you know, like you would a needle, you put it in 4
the specimen and get a reading, and that gives you 5
precise information about that specimen; or they're 6
using an infrared temperature device, so they shoot 7
the cup and they get a temperature reading.
8 Why am I talking about this? Well, 90 9
to 100 degrees, all human beings can produce a 10 specimen in that range, although the lower range, I 11 think, you'd be in pretty dire straits. Certainly, 12 you can get over 100 degrees, and as a father of 13 two young children, I know that fact that you can 14 get a fever of well over 100 degrees.
15 Those temperature measurement devices, 16 if you have a specimen that's 80 degrees or 115 17 degrees? Not humanly possible. An individual 18 cannot function at that temperature, so that's 19 definitive proof of a cheating event. Right?
20 Well, in the case of these urine 21 specimens, we tighten that range a bit and move 22 somebody to an observed collection. And if we have 23 oral fluid in place instead of a urine or you have 24 options, that may be appropriate, and we should 25
53 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com consider that.
1 And then, the last piece that I think 2
is really important. When the 2008 final rule came 3
into being -- and this is where we added the 4
permanent denial for a subversion attempt -- that 5
rulemaking, in part, was incorporating, you know, 6
the threat environment from 9/11, right? And we 7
focused on trustworthy and reliability.
8 Radiological sabotage is as serious as it gets at 9
the NRC, and we focus on people that could do bad 10 things. That's the trustworthiness part of it.
11 And the reliability piece is twofold, right, so we 12 look at the drugs.
13
- Anyhow, so, in 2008 we implement 14 permanent denial of unescorted access for 15 subversion attempts. At that time, the NRC did not 16 understand, or maybe the trend has changed over 17 time, that many people were subverting the process.
18 We collect really precise information, and we know 19 how people are doing it and we know how many people 20 are doing it every year. But back in 2008, either 21 it wasn't occurring very often or we didn't have a 22 good measurement tool to identify it. But now we 23 do, and so, our regulations need to improve to 24 benefit from all our lessons learned in the area of 25
54 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MRO overviews of test results.
1 So the MROs, the front line, they're a 2
donor protector. They're a medical doctor. They 3
review the test result, they evaluate the test 4
result, and they make the determination if someone 5
has violated the FFD policy with a confirmed drug 6
positive or adulterated or substituted validity 7
test result. And so, they're the front line in 8
terms of evaluating those results.
9 So, there's a couple of conditions 10 where MROs have reviewed results, and our rule may 11 not have enough clarity in there to make that 12 review as simple as possible. But what we know 13 from so many events each year is there are a couple 14 of kinds of categories of events where we could 15 improve our MRO review information.
16 One is the initial specimen is out of 17 temperature, but there's a laboratory test that is 18 negative. The second specimen that's collected 19 under direct observation at the same event, the 20 same time, you know, within that period of time 21 when that individual is still at the collection 22 site, is returned positive. So it's impossible, 23 humanly impossible to produce a negative on the 24 initial if the second is positive.
25
55 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com And, oh, by the way, there's generally 1
other information that's consistent with a cheating 2
event, right, independent of the positive/negative.
3 The temperature of the first specimen is 80 4
degrees, and the one that's observed is 95 degrees.
5 You can't do that as a human being, right?
6 So, that's one event. That's the 7
primary way that we identify cheaters -- the 8
temperature is out of range and whether they 9
provide another specimen is the second piece.
10 They'll either refuse the collection, or they'll 11 provide the specimen.
12 Second one is a first specimen that's 13 invalid. So, individuals can put things into their 14 specimen to interfere with the test and get an 15 invalid result.
16 There are legitimate reasons why you 17 can have an invalid result, but the drug testing 18 that's performed on a specimen, it's an immunoassay 19 using antibodies. You can interfere with those 20 antibodies. And so, if we get an invalid result, 21 the MRO is going to look at that result and they're 22 going to evaluate if you're taking a particular 23 medicine that may cause that to interfere with that 24 assay. And if there's no medical explanation, you 25
56 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com have to come back in and you're going to be under 1
direct observation, because that's information that 2
suggests you may have cheated. And the second 3
specimen collected tends to be positive. It's 4
positive, or they refuse it.
5 That's how we see those. Those are not 6
a large number of subversions each year, but we do 7
see these each year. That's another circumstance 8
the MRO is going to review two results. They're 9
going to review a specimen that was collected on 10 Monday, and they're going to bring that person in 11 seven or ten days later for a second collection.
12 And then the last one, and we've seen 13 this more over time, is you're going to get two 14 specimens. The first one is out of temperature.
15 MRO is going to request a donor to provide a 16 specimen under direct observation. They're going 17 to agree to it, and you get two specimens. Both of 18 them come back negative.
19 So, we don't test for every known 20 substance out there that could be impairing. And 21 maybe the person cheated, and they used drugs three 22 weeks ago and it's out of their system, but they 23 got caught cheating. Now, the key piece on that 24 one is, even though it's not positive, there's a 25
57 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com lot of information that's collected at those two 1
collection events that can tell you whether that 2
individual, that specimen was from that individual.
3 So, this is an important one where you 4
need to be looking at the specimens, you know: the 5
specimen's temperature, the pH of the specimens 6
collected.
You can't get great levels of 7
variability from an individual in a short period of 8
time. So if someone, again, has 110 degree 9
temperature on the initial specimen, and when you 10 hit that cup with an infrared gun on the second 11 specimen and it's 95 degrees, it's impossible for 12 somebody to produce variations of temperature that 13 way.
14
- And, seemingly, creatinine is a
15 measure. It's a biological substance produced by 16 your bodys muscle metabolism. There's a standard 17 range in your urine specimen, and you can't get a 18 great level of variability in those from specimen 19 to specimen. So if you use a synthetic urine, it's 20 going to have a particular creatinine that's added, 21 but your body is going to have a much different 22 level or could have a different level. Same thing 23 with pH. The pH can be different from the 24 specimens, and that's other information. And then 25
58 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com specific gravity.
That's the density of a
1 substance.
2 So, those are elements that are very 3
important, but our rule does not articulate in much 4
clarity. Its a responsibility of the MRO to look 5
at all the information about a subversion attempt.
6 But we can inform our process better now from years 7
of experience in seeing these types of events.
8 So, that's subversions. Those are the 9
areas, some of the areas that we think are 10 important areas that are compelling to move forward 11 with rulemaking and to improve in our regulations.
12 Let's stop for a second. Anybody have 13 any questions about that one? I know we're at 14 2:00. Johnny? Yes. Okay, Johnny.
15 MR. ROGERS: Brian, thank you for this 16 information. It's very thorough and exactly what 17 we've talked about for years.
18 I want to go back to shy bladder for 19 just a second and ask you about consideration for 20 the use of oral fluid in circumstances where 21 someone's unable to produce. You know about the 22 verbiage of the shy bladder section how, you know, 23 to get an evaluation done within a five-day period 24 and how arduous that can be and how we sort of 25
59 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com tripped over ourselves over the years not being 1
able to meet that requirement --
2 MR. ZALESKI: Right.
3 MR. ROGERS: -- and trying to meet the 4
rule at the same time. Would there be any 5
consideration
- for, when oral fluid becomes 6
available, to use oral fluid in lieu of that 7
medical evaluation piece to satisfy the 8
requirements of the drug screen?
9 MR. ZALESKI: Yes, that's a great 10 question. So, let's just provide a tiny bit of 11 information there.
12 So, you're talking about a limited 13 period of time. So, if an individual cannot 14 produce a urine specimen within three hours and 15 after being provided with 40 ounces of fluid water, 16 they need to get a medical evaluation within five 17 days of that event, right? And if they can't do 18 that, that would be considered a refusal to test.
19 So, there are reasons why people don't 20 provide specimens. One, they know they're going to 21 test positive and they don't provide a specimen.
22 But somebody could have a medical condition.
23 As you know, and I think most people on 24 this phone
- know, it's difficult to get an 25
60 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com appointment with a doctor. And in this case, it's 1
a specialist, right? You need to see somebody who 2
really knows, is trained in urology or some other 3
area that's maybe impacting your ability to produce 4
a urine specimen.
5 So,
- yes, I
think DOT has some 6
information in their rule about that. I think the 7
HHS Guidelines may also have some information on 8
that. I think it should be a part of it.
9 And also, while I may not have that on 10 the slides, Johnny, I think that it is something 11 that we should be looking at. You know, why a 12 five-day turnaround time? Is there another way 13 that we can get a medical evaluation to ensure that 14 we protect the donor and we have regulations that 15 comport with what in society is existing to 16 evaluate a medical condition, right? How do we do 17 that?
18 So, yes, I think absolutely that should 19 be within consideration, that we have more tools to 20 improve our ability to collect a specimen from an 21 individual in a timely manner, yes, and make our 22 rule more effective and efficient. So, yes, I 23 think that's a great point, and it's certainly on 24 my radar for sure.
25
61 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. ROGERS: Thank you.
1 MR. ZALESKI: Okay. Blind specimens.
2 This is an important one. It's a critical one. We 3
have received public comment on this in the 2019 4
proposed rule. These were out-of-scope comments 5
because we were not proposing any changes to the 6
submission requirement.
7 So, what are blind specimens? Every 8
quarter we require our licensees to submit known 9
specimens that are formulated specifically to 10 challenge that laboratory. The blind specimens are 11 sent to the laboratory like they're a donor 12 specimen. They're prepared in the same way. They 13 have a name on the paperwork. They appear normal.
14 And what we expect to get back from the laboratory 15 is the same result as what that specimen was 16 formulated.
17 So, that's a quarterly requirement.
18 You have to submit blinds for everything that we 19 test for, as well as any validity testing issues.
20 So, that's the adulterated specimen. I added 21 something to my specimen like soap or an oxidant to 22 interfere with the test. "Substituted" means, 23 again, you're putting a colored fluid that looks 24 like urine, but it doesn't have creatinine and its 25
62 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com density is off, to suggest that it's not urine.
1 So, we have specific formulation 2
requirements on a quarterly basis that challenge 3
each laboratory that a licensee utilizes under 4
contract. Okay. So, we have these requirements.
5 Why do we have them?
6 We have them to verify that the 7
laboratories, in fact, can identify everything that 8
we're required to have them identify and they're 9
going to consistently do it. So, it's a challenge 10 to the laboratory, and that's an important one.
11 And it's also like building muscle at 12 the programmatic level from a fitness-for-duty 13 program perspective. So, let's think about this.
14 One percent, I think, overall, the 15 industry positive rate is about 1 percent. That's 16 all the different tests that you could collect for 17 any reason. It's about 1 percent, maybe a little 18 bit higher, maybe a little bit lower. So, that's 1 19 out of 100 individuals tested will test positive.
20 So, a single reactor unit maybe has 800 21 to 1,000 people. So, you're not going to have a 22 ton of positive results in a year. So, one way of 23 exercising to ensure that every element of the 24 testing process is in place from the specimen 25
63 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com collection to the testing of it; to the result 1
review from the licensee; the reporting of that 2
paperwork, and the testing of all the different 3
substances from the laboratory is challenged by the 4
blind specimen program. So, that's blinds.
5 You have specific requirements about 6
minimum numbers that need to be submitted on a 7
quarterly basis. And the first line item talks 8
about a new contract. So, if you have a new 9
contract with a laboratory, you have to send in a 10 lot more blinds in that first 90-day quarter.
11 Why do I put that there? You know, it 12 might not be necessary to submit as many new 13 blinds, right? And one of my thoughts on this one 14 is, if you're submitting a specimen to a laboratory 15 that's already performing NRC testing for another 16
- licensee, why?
We already know that that 17 laboratory can do the testing for the NRC for a 18 licensee that's consistent with the same drug-19 testing panel, et cetera. We may not need to have 20 so many blinds in that first quarter.
21 And also, that's a barrier to change 22 your laboratory, right? If you're unhappy with 23 your laboratory and you want to switch to a new 24 laboratory, you're going to have to spend money and 25
64 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com submit a lot more blinds in that first quarter, 1
based on a rule requirement. So, that may not be 2
necessary.
3 And why am I bringing this up in terms 4
of changing labs? Well, you just implemented a 5
final rule, right? And I know a number of the 6
sites wanted to implement changes more quickly, but 7
they couldn't because their laboratory wasn't able 8
to change their approach and be able to test for 9
the NRC panel in a timely manner.
10 You may want to switch laboratories.
11 So, if you have the ability to do that because you 12 don't have as many blinds, that may be beneficial, 13 right? It provides flexibility, but it also gives 14 you the ability without any loss in assurance.
15 I should have said at the start of 16 this, too, you know, talk about risk-informed. All 17 of these are risk-informed, right? This one is 18 risk-informed. If we've already challenging that 19 laboratory and other licensees are using them, 20 there's really no reason why you have to submit so 21 many extra blinds in the first quarter. So, that's 22 the first one.
23 Quarterly submittal requirements. I'm 24 going to drag another table onto the screen here.
25
65 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Give me one second.
1 All right. So, this is a table that we 2
created. It's in our inspection procedure. We put 3
it in three or four years ago. Everybody should 4
have seen this slide. Anybody that went to any 5
public meeting that we had on the Part 26 final 6
rule would have seen this.
7 And this slide demonstrates the 8
complexity of what we ask of our licensees to 9
submit, right? So, I wanted to just briefly share 10 this with you and present it to you as one way we 11 maybe can think about simplifying things.
12 So, each quarter you have to submit all 13 the drugs -- one specimen or you could have one 14 specimen that has multiple drugs, but there's only 15 one blind specimen provider that the entire 16 industry uses. So, we know what kind of blind 17 specimens you can get from that provider. So, this 18 table is kind of based on that.
19 So, every quarter you have to submit 20 one specimen for each drug. So, there's some 21 additional requirements that we have. Each quarter 22 you have to submit, actually, two blind specimens 23 for marijuana. And in two quarters, you have to 24 swap out a PCP for another cocaine. There's 25
66 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com complexity that I'm not sure provides any value.
1 I could tell you that the thinking 2
behind that, back in the day, marijuana and cocaine 3
were the two most detected substances. And 4
marijuana still is the most detected substance in 5
our program by a long shot. So, maybe we need to 6
challenge that laboratory more. That's why we're 7
pushing two blinds through - the marijuana blinds 8
through.
9 But we're also having a lot of people 10 test positive for marijuana. And I don't think 11 I've seen much information out there to support 12 that having additional blinds in the marijuana 13 category per se is necessarily beneficial.
14 So, what would be simpler, in my mind, 15 is just to say that you have to cover all the 16 substances in the testing panel each quarter, 17 period -- not two marijuanas in a quarter and 18 switch out PCP for cocaine. That's a complexity 19 that I don't think has much value.
20 So, that's the nugget here in terms of 21 complexity. Let's try to make this simpler if we 22 can. Everybody submits these quarterly and I'm 23 sure everybody has an opinion about them.
24 The third one is industry uses a 25
67 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com limited number of HHS-certified laboratories. And 1
I think there's a variety of reasons on that one, 2
right? We have an annual auditing requirement to 3
look at the laboratory. You can share those audit 4
results. There's value in using a laboratory that 5
has more than one location. So, there aren't that 6
many laboratories that have multiple locations, you 7
know, under the same umbrella company.
8 So, industry, as of 2022's data, there 9
were nine HHS-certified laboratories that supported 10 the entire industry. And really, there's like four 11 or five that do the vast majority of the testing.
12 So, we have a lot of blinds that are 13 coming from each of our sites going to the same 14 laboratories, right? You see what I'm getting at.
15 We're sending a lot of blinds. We're challenging 16 those laboratories.
We're getting assurance 17 they're doing things well.
18 So, we might be able to take advantage 19 of that
- efficacy, right, by using those 20 laboratories, the numbers. We might be able to 21 look at the percentages that were submitting.
22 And then, finally, I'm not sure there's 23 great clarity in our rule on this one. Some sites 24 manage their blind program based on a fleet level 25
68 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com and some on a site-specific level. There are 1
minimum blind specimen requirements that apply each 2
quarter, and most of the sites will never get 3
beyond the minimum, which is 1 percent, or 10.
4 And without getting into too much 5
detail, you're not going to really be thinking 6
about percentages for blinds that you submit to the 7
laboratory if you test less than 1,000 specimens.
8 Most sites are not going to test more than 1,000 9
specimens in a given quarter. Maybe if you're in 10 outage, maybe a three-unit reactor site might get 11 to that point. Certainly, if you're using a fleet, 12 you're getting to the percentage range.
13 We should be clear about what the blind 14 specimen requirements mean. Is it site-specific?
15 Is it at the fleet level? Are there advantages to 16 either of those? That's that nugget.
17 Now, we did get comments saying, hey, 18 NRC, we want you to eliminate the blind program 19 because the DOT did that in 2017. They eliminated 20 their blind program. That's the same rulemaking 21 that I referenced earlier, but I didn't highlight 22 that element of it.
But I
certainly will 23 acknowledge that they did eliminate their blind 24 program. And I encourage you to read that rule, 25
69 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com and it's linked on that slide.
1 And the basis they had for eliminating 2
it is they said, well, we use HHS-certified labs; 3
we require our licensees to test the same panel 4
that the federal program is using. And by the way, 5
the certification process, they challenge these 6
laboratories as well.
7 So, HHS sends what's called performance 8
testing samples to these labs every quarter and 9
checks them as well. True. That is true, but what 10 was the basis for the DOT saying, "We don't need to 11 do blinds anymore," they didn't have any false 12 negatives or false positives. They didn't have any 13 performance issues at those laboratories, and that 14 was the basis for the change.
15 We get reportable events every year 16 that demonstrate that there is unsatisfactory 17 performance at the HHS-certified laboratories used 18 by our licensees. It doesn't happen all that 19 often, maybe five or six times a year, but we get 20 26.719(c)
- reports, and they indicate the 21 performance deficiencies at that laboratory or 22 laboratories. And we see them every year.
23 So, we have data that demonstrate that 24 the blinds program is identifying issues that we 25
70 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com want to make sure we're identifying and we're 1
correcting them, so that we don't have a deficiency 2
in our program. Because if the laboratory can't 3
test the drugs that we require them to test, then 4
the program that we have is really not functioning 5
as it's required to function.
6 So, we challenge laboratories every 7
quarter. We get results coming back that indicate 8
issues of unsatisfactory performance. And I can 9
offer lots of details to demonstrate why I think 10 that's important.
11 Another reason, unlike other federal 12 agencies, we have mandatory minimum sanctions for 13 violations of our program, right? So, that's a 14 consequence to that individual. And so, we want to 15 make sure that that laboratory's test is accurate, 16 highly accurate.
17 Now, of course, donors have the ability 18 to do a retest at another laboratory, right? And 19 that was one of the bases that DOT said, well, you 20 know, an individual can request a retest at another 21 laboratory. So, if the first laboratory errs, you 22 send that specimen to another laboratory.
23 That is true, but the piece of it that 24 you don't get with the donor protection piece is 25
71 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com the false negatives, right? So, there's something 1
going on in the laboratory and we send a formulated 2
specimen that's positive for marijuana, and the 3
laboratory reports it as negative. So, you had a 4
negative result and we just granted access to an 5
individual that, in fact, had drugs in their body.
6 That's a bad day for all of us and we can't have 7
that.
8 And the blind program challenges the 9
laboratories in that way, and we've identified a 10 number of false negatives. That doesnt happen all 11 that often, and there are reasons for it, but we 12 want to make sure that we challenge the laboratory; 13 get those issues corrected.
14 A lot of times, it's the certifying 15 scientist that's checking the wrong box or they're 16 not following standard operating procedure. And 17 again, NRC is not the driver of testing in the 18 United States.
It's the Department of 19 Transportation. Six million tests a year versus 20 110,000 tests a year. So, we have to exercise the 21 laboratory muscle with the blinds. So, that's 22 another reason why I believe it's appropriate and 23 necessary to continue with our blinds.
24 Special analysis testing. That's where 25
72 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com we drop the cutoff levels lower if we believe 1
someone is cheating or -- primarily, if we believe 2
someone is cheating. And we strengthened those 3
requirements in the 2022 final rule, but that's 4
unique. No other federal agency uses that tool.
5 Subversion attempts are a very, very fundamental 6
issue for us because it's untrustworthy and 7
unreliable, and we permanently deny it. So again, 8
we want to make sure that that laboratory is doing 9
things correctly under those circumstances.
10 And
- then, lastly, we provide 11 flexibility to licensees to test for any controlled 12 substance in the United States. Anything that's 13 controlled, Schedules I to V, a licensee can test 14 for, and they can also test for the panel of drugs 15 that we have at lower cutoff levels.
16 That doesn't occur in the HHS federal 17 workplace drug testing world and it doesn't happen 18 in the DOT testing world, but we enable our 19 licensees to use lower cutoff levels and we allow 20 them to test for additional substances. And there 21 are not many, but there are sites that do use lower 22 cutoff levels and do test for more substances.
23 So, because of the uniqueness of that, 24 the HHS certification process wouldn't validate 25
73 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com that, and therefore, those are the fundamental four 1
reasons why we really do need the blind program in 2
place, but I believe that we can take advantage of 3
a lot of lessons learned, and also, how the 4
industry works; which laboratories we use.
5 And the end result is we can maintain 6
the assurance that we need, but we can also save 7
money because you don't have to submit as many 8
blinds, right? That's a benefit for everybody who 9
spends the time to formulate them. As long as we 10 have the same assurance, which I do believe we can 11 get by improving the numbers and the simplicity of 12 our requirements, I think we can have a win/win 13 there.
14 All right. Alcohol. Alcohol is an 15 important topic. It's come up in a variety of --
16 oops, Johnny, you have a comment or question?
17 Sure. Go ahead.
18 MR. ROGERS: Yes, Brian, I just wanted 19 to come alongside your comment on blind specimens.
20 I think the issue here, as I think you've already 21 stated, is the perceived burden and the cost of 22 doing repetitive testing. And you've already made 23 a point of that.
24 So, I just want to clarify. Did I hear 25
74 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com you correctly when you said there is something we 1
can do about that, and we can evaluate the 2
efficiency and effectiveness of our program by 3
considering lowering the blind specimen standards, 4
such that maybe it's a shared responsibility among 5
the
- sites, as opposed to everybody sending 6
specimens in every quarter and testing on that 7
level? Might there be some consideration for a 8
shared responsibility?
9 And
- then, maybe even another 10 reevaluation. I just find it curious that DOT 11 tests 6 million specimens a year, and yet, has had 12 no significant issues with the lab. And we test a 13 fraction of that, and we see issues. I'd like to 14 look at that comparative data. So, if we're open 15 to looking at that in consideration, I'll put that 16 out there. But, at a minimum, I think the industry 17 would like to see some relief and consideration for 18 the level we are testing.
19 As you know, blinds are very expensive, 20 and if we're not getting the juice for the squeeze 21 or the bang for the buck, or however we want to 22 phrase that, I think we ought to consider a shared 23 responsibility as a minimum.
24 MR. ZALESKI: Yes, and I think there 25
75 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com are a lot of different ways that we can approach 1
that where we can meet the performance objective, 2
which is to ensure the laboratories can identify 3
all the different things that we require them to 4
test for, and make sure that we're not submitting 5
more than we need to do that, right? And there's a 6
variety of ways to do that.
7 And in terms of the DOT, I can't tell 8
you if there's a reporting requirement for them for 9
the licensee to report unsatisfactory performance, 10 and we'd have to look into that more. But I can 11 tell you that they did not see false positives, 12 false negatives. And I'd have to see if they have 13 any information or how they capture that 14 information.
15 I can tell you that, when we get a 30-16 day event report, our rule requires us to notify 17 HHS, and we send it to the Division of Workplace 18 Programs, the head of the Division of Workplace 19 Programs, and then, NLCP is going to look at that.
20 They're going to look at that event and they're 21 going to make sure that it's investigated.
22 And so, we know that there's been 23 unsatisfactory performance. That's a challenge to 24 our program. So, it's important to challenge the 25
76 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com laboratories and ensure that we have consistency 1
there.
2 But, yes, not to belabor the point, I 3
think everything is on the table. How can we 4
maximize the efficiency of the program; make sure 5
the laboratories can identify everything that we're 6
testing, and there are a variety of ways to do 7
that. And I'm open-minded about how we can come 8
about doing that for sure.
9 Okay. I was going to talk about 10 alcohol, right?
11 MR. ROGERS: But no, no, no. No, I 12 wanted to go back to what you were just saying.
13 So, we're open to considering all 14 options, including eliminating blinds, if it can be 15 warranted and justified that we can meet 16 programmatic standards. We would at least look at 17 it and consider it, to be fair?
18 MR. ZALESKI: Regulated entities have 19 the opportunity to provide any information they 20 want, you know, on rulemaking, whether it's right 21 now or if we get to the proposed and final rule 22 stages, to demonstrate why they believe their 23 position is appropriate, right? Any information 24 you have, you could provide that in rulemaking 25
77 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com space to demonstrate why you think the agency's 1
process/requirement is appropriate or not 2
appropriate.
3 So, all those tools are on the table.
4 What I'm telling you from my perspective in looking 5
at the data that we
- have, we've identified 6
unsatisfactory events every year from the testing 7
of blinds, I believe, and that demonstrates we have 8
a need to continue. So, that's all I'm saying.
9 So, all of these things are on the 10 table. Obviously, any piece of Part 26 is on the 11 table for review and for public comment during 12 rulemakings, and I look forward to having further 13 discussion.
14 In the interest of time, I want to make 15 sure I move forward --
16 MR. SCHNEIDER: I just want to make one 17 comment, Brian, for Johnny to understand that, as 18 we develop the regulatory
- basis, that the 19 regulatory basis will include the staff's 20 recommendations on how to proceed and the preferred 21 option. And that's where this would be vetted out 22 on the staff side, and then, you could comment on 23 that. And that would help us to inform the 24 proposed rule.
25
78 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com So, you will see what the staff 1
believes to be the recommended option that they 2
would use in the proposed rule, and you would have 3
two times the opportunity to comment on that.
4 MR. ZALESKI: And I will say one last 5
thing on blinds. The Federal Workplace Drug 6
Testing Program, the HHS guidelines, they have a 7
blind specimen program and they require federal 8
agencies to send those to their own laboratories 9
that are certified. So, we still have that in 10 place at the federal level.
11 So, there is, clearly, a difference 12 with DOT and HHS and NRC. So, we can evaluate 13 those differences and move on.
14 MR. SCHNEIDER: But what I'm trying to 15 say here is you will, from the regulatory basis, 16 glean the approach that the staff has provided to 17 the Commission on the way to go forward --
18 MR. ZALESKI: Right.
19 MR. SCHNEIDER: -- which you can then 20 comment on, whether you agree or disagree in whole 21 or in part.
22 MR. ZALESKI: Right.
23 MR. SCHNEIDER: Thank you.
24 MR. ROGERS: Very good. Thank you.
25
79 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. ZALESKI: Yes, and I think all I 1
was trying to accomplish is to demonstrate that 2
there are areas we believe need additional work, 3
right, to improve the effectiveness, efficiency, et 4
cetera. And the blind program is, clearly, one of 5
them.
6 Okay. Alcohol. So, we're at 228. I'm 7
on slide 17 of 26. I think it's really 23 or 24.
8 So, I'm going to move a little bit quicker, but not 9
too much quicker. I think we'll be able to get 10 through these things.
11 So, there's a couple of things with 12 alcohol. Part 26 does not define what alcohol is.
13 We have a variety of requirements that treat 14 alcohol very seriously, for obvious reasons. It's 15 impairing; it's readily available. Many, many 16 people in the population use it and it's legal to 17 use alcohol if you are of age. So, there are 18 reasons why we have a lot of defense-in-depth with 19 respect to alcohol.
20 We have reportability requirements.
21 So, if you consume alcohol in the protected area or 22 you identify alcohol in the protected area, you 23 need to report that to the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. If 24 you're identified consuming alcohol within the 25
80 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com protected area or while you're performing duties, 1
that's a minimum five-year denial. That's a 2
minimum sanction. That's a serious sanction.
3 We prohibit consumption at least five 4
hours before you arrive onsite. That's in the FFD 5
policy. Everybody is subject to the FFD program is 6
initially trained, and then, annually retrained.
7 They're trained on this. They're prohibited from 8
consuming alcohol at least five hours in advance of 9
coming to work. And even then, it might not be 10 sufficient. And they're prohibited from using 11 alcohol on duty.
12 In addition, if they're not planned for 13 coming into work, and, for example, there's an 14 emergency and they need to come into work, we even 15 have a provision in place for an individual to 16 disclose that, in fact, they were drinking alcohol 17 because they didn't plan to come to work. And 18 there's provisions in place in the rule to mitigate 19 the risk: test the person, et cetera.
20 So, there's a lot of defense-in-depth 21 about alcohol, including time-dependent alcohol 22 levels. How long you've been onsite and what's the 23 level of alcohol. Because alcohol, unlike drugs, 24 it's very standard in terms of the amount of 25
81 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com alcohol that dissipates in your body over time, and 1
that's why we have time-dependent alcohol testing 2
violation levels. And they've proven to be very 3
effective in identifying alcohol use.
4 Since
- 2008, we've had these; we 5
implemented time-dependent alcohol levels. Over 30 6
percent of the alcohol testing violations are the 7
result of time-dependent alcohol levels, meaning 8
they're less than.04, but you were in work status 9
long enough that, when you arrived on shift, you 10 had a.04 in your body.
11 So, we have a lot of requirements in 12 place, but what we don't do in our rule well, and 13 what we've become aware of over the years, is there 14 are products out there that contain alcohol at 15 various levels. They may or may not be impairing, 16 right?
17 So, one of the examples is kombucha.
18 Fifteen years ago or 10 years ago, there werent 19 grocery stores in the United States selling 20 kombucha. Kombucha is a fermented product with a 21 very, very low level of alcohol. You could drink 5 22 gallons of it and it would not impair you. You 23 would get sick, right? You would throw up. But 24 there's not enough alcohol in that product to get 25
82 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com you impaired, right? But it has alcohol on the 1
label.
2 So, we've had some guidance out there.
3 We need to improve our rule to address alcohol, to 4
be clear that our focus in Part 26 is impairment, 5
mitigating impairment, making sure an individual 6
safely and competently performs their assigned 7
duties.
8 So, we've gotten a number of questions 9
on it. We've had some uncertainty from licensees 10 in terms of when they need to report something.
11 And so, clearly, we need to do a better job, right?
12 So, this is the space to do it and we can correct 13 some of these through rulemaking. And I want to 14 acknowledge that and it's an important item for the 15 agency.
16 Substance abuse experts. And I think 17 you'll notice a trend in terms of the topic areas.
18 Sure, Johnny. Yes?
19 MR. ROGERS: I'll be brief, Brian, 20 because I know we're pressed for time.
21 With respect to the five-hour rule, 22 we're not considering or addressing impairing 23 substances, you
- know, that may impair an 24 individual's ability to perform safely and 25
83 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com competently. And the classic example is inhalants 1
and other substances.
2 So, rather than just focus on alcohol, 3
would we consider other impairing substances that 4
could impair, do impair, with respect to the five-5 hour rule? Because it's only specific to alcohol.
6 And I'm, of course, citing a classic 7
case where we had inhalant use inside the protected 8
area.
9 MR. ZALESKI: Right.
10 MR. ROGERS: Would we consider examples 11 for that for rulemaking?
12 MR. ZALESKI: Yes, and I will move to 13 the end of the slide deck and just touch on that 14 real briefly, and I'll come back, right?
15 So, at the end, we have a number of 16 out-of-scope comments that were out-of-scope only 17 because they didn't pertain to the proposals for 18 change in the 2019 Part 26 rule.
19 But one of them, I believe, in here 20
-- one of the comments that we have is a public 21 comment related to use of impairing substances that 22 are not tested for, right? So, we're a fitness-23 for-duty program. Our performance objective is any 24 substance that's impairing, right? So, yes, I 25
84 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com think we do need to look at that, and if there's a 1
way that we can effectively manage that in 2
regulatory space, that would be appropriate to take 3
a look at.
4 I mean, you know, for example, the FAA 5
has -- what is it? -- the 5 half-life rule, right?
6 And that's for any -- I think if you take a 7
medicine and it says you are to use it every four 8
hours, you have to wait 5 half-lives. So, usually 9
the labeling requirement, if it says four hours, 10 that means in four hours you'll get 1 half-life.
11 So, 50 percent of that substance will be out of 12 your body. And FAA requires 5 half-lives, right?
13 And that's for medicine, over-the-counter or not.
14 So, there are a variety of federal 15 agencies that do look at over-the-counter 16 medicines. And you're talking about a computer 17 cleaning solvent, and I know that, in fact, for 18 that reportable event where somebody is huffing a 19 solvent, so that's not even an over-the-counter 20 substance. That's another impairing product out 21 there, right?
22 Yes, we need people to be safe and be 23 able to do their job with all of their faculties.
24 So, yes, we need to look at that, right? We 25
85 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com definitely do.
1 MR. ROGERS: So, expanding the five-2 hour rule for other substances?
3 MR. ZALESKI: Maybe that's the way to 4
do it. Maybe there are other ways to do it. But 5
it's something that we definitely have to consider, 6
that I think we need to consider, sure.
7 MR. ROGERS: Understand. Thank you.
8 MR. ZALESKI: Yes. Okay. Substance 9
abuse experts. I talked before a bit about medical 10 review officers with respect to subversion 11 attempts, right? But broader than that, medical 12 review officers are looking at test results.
13 So, substance abuse experts can act 14 when an individual has violated the testing policy, 15 okay, and we're going to evaluate this individual 16 if the licensee chooses to continue to want to 17 employ that individual. So, the individual is not 18 working right now because they had a violation.
19 They're going to evaluate them. They're going to 20 identify
- what, if
- any, treatment they need.
21 They're going to develop a program for them and a 22 followup testing program if they do believe that 23 they are appropriate to return to duty, and then, 24 they'll be tested for a long period of time.
25
86 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com So, a substance abuse expert is a 1
highly trained, skilled professional in the area of 2
substance use disorders. They're going to be the 3
individual that evaluates somebody with a testing 4
violation or, you know, there's a legal event, a 5
legal action. Somebody reports a DUI and you get a 6
fitness determination. That's the process that's 7
initiated if you get information like that.
8 So, it's a very important function 9
that's served by these professionals. Under Part 10 26, the substance abuse expert role did not exist 11 prior to 2008. Prior to 2008, the medical review 12 officer was doing that. But, in 2008, we created 13 this role for the substance abuse experts because 14 not all MROs had the necessary experience and 15 skills to meet that requirements under the role.
16 And that's based on a public comment we received, 17 right?
18 So, this is relatively new in terms of 19 Part 26, you know, having substance abuse experts 20 in the role that they play in the program. One or 21 two pieces that I want to mention. Then, I'll move 22 on.
23 So, substance abuse experts, there are 24 functions that are served by people that may not 25
87 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com have access to a plant. So, most of the people 1
that are subject to a Part 26 drug and alcohol 2
testing program have what's called unescorted 3
access. It means you walk through the gate, and if 4
you get through security, no one's with you and 5
you're by yourself. That's unescorted access and 6
that's a privilege, and we bestow that privilege 7
upon people. And there's a lot of things that we 8
do to make sure they're safe to do that.
9 Other people support the program, but 10 they may not have any reason to be on that site. A 11 medical review officer is an example; substance 12 abuse expert is also an example. They could be 13 working in another state. They could work in a 14 doctor's office, and a lot of the work they're 15 doing doesn't require them to be onsite.
16 They're looking at a laboratory test 17 result, which is a printout. They're talking to a 18 human being on the phone. They're saying, "Can you 19 explain to me why you tested positive for this?"
20 "Yes, I have a valid prescription." "No, I don't 21 have a valid prescription."
22 So, they're evaluating. It's a donor 23 protection. So, SAEs can also be serving in that 24 function where they're not onsite. They don't have 25
88 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com unescorted access.
1 And we have received questions 2
associated with whether they should be subject to a 3
fitness-for-duty program, and that ties into the 4
first bullet, which is FFD program personnel.
5 So, there's a category of people that 6
may not have unescorted access, but because of the 7
function they perform for a program, they would be 8
subject to a fitness-for-duty program. And that 9
FFD program personnel definition is in 26.4(g), and 10 it talks about activities performed, generally, by 11 the MRO or a specimen collector or a person who's 12 administering the FFD program.
13 What's lacking in that is some clarity 14 and some terminology. One is, it says, you know, 15 FFD program personnel are involved in the day-to-16 day operations of the program. We don't define 17 what "day-to-day" is. And by the way, most people 18 that do FFD program functions don't do the job day 19 to day. So, we need to get some more clarity with 20 what "day-to-day" means. We need to get some more 21 clarity on what FFD program personnel means. And 22 that does impact substance abuse experts.
23 So, I'll leave it there, but we can 24 improve the clarity of our requirements associated 25
89 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com with fitness-for-duty program personnel, and we 1
have learned a lot about that piece through 2
substance abuse experts and sort of the changing 3
work environment and people working remotely and 4
having access to technology, right? You know, lots 5
of change. Lots of changes occurred in society 6
since the COVID pandemic, and even before then.
7 Behavior observation.
That's a
8 fundamental part of our program. It's defense-in-9 depth. When someone's granted unescorted access, 10 there's really two ways we continue to ensure that 11 they're safe and secure, right, in what they do.
12 One is we test them on random, and the other one is 13 they're subject to a behavior observation program.
14 So, if an individual is demonstrating 15 aberrant behavior or they're saying to somebody 16 else, "Hey, I beat my drug test" or, "I smoked 17 marijuana last weekend," you know, that individual 18 that receives that information is obligated to 19 report it to the fitness-for-duty program and the 20 licensee is obligated, under Part 26 -- and Part 21 73, depending on the kind of information -- to 22 disposition that information, evaluate it.
23 If it's credible information, then you 24 take action. Generally, that's a test, but it 25
90 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com could be other things.
1 So, if someone's not working on the 2
site, are they subject to behavior observation, and 3
what does that mean? If I can't put eyes on that 4
person because they're not working in front of me, 5
what does that mean? So, the behavior observation 6
component, it's an important question, something 7
that we should look into further.
8 And one other one, and then, I'll move 9
on, is the face-to-face.
There's only one 10 requirement in the rule that says you have to do 11 this face-to-face, the determination of fitness, 12 and it's for cause.
So, if someone is 13 demonstrating signs of impairment, aberrant 14 behavior, it needs to be performed in person.
15 Does it have to happen? Can we do that 16 evaluation either with a virtual element to it or 17 does it have to be in person? You know, technology 18 has changed over time. We should be looking at 19 that and seeing if we can improve on that element.
20 And by the way, the topics that have 21 been presented here have come up, again, from 22 questions we received and inspections that have 23 been performed, and dialogue that we've had on 24 questions where we don't have a simple answer in 25
91 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com some cases, right? Our rule is not clear enough.
1 We need to do something. We can sometimes issue 2
guidance. Sometimes we have to go back and we have 3
to improve the rule, right?
4 So, that's the frame for all the things 5
that are on this slide, I think.
6 MROs. This is going to tie back to 7
prior slides that I've spoken about in two key 8
areas. MROs serve an extremely important function 9
for our programs. They are protecting the donor 10 and making sure that the test result that is 11 received from a laboratory is a legitimate test 12 result; that the individual is not being sanctioned 13 because they have a prescription. That is, they're 14 taking a medicine appropriately and there's no 15 safety implications. So the MRO is the trained 16 expert the licensee employs to do that evaluation.
17 However, we do not have great tools in 18 place in Part 26 to assist the MROs in doing their 19 jobs effectively. And one area, which I'd argue 20 that, you know, it wasn't as much of a challenge 21 back in 1990, but it has become a significant 22 challenge today and over the last 10 years, is 23 medicines.
24 People can take medicines that are 25
92 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com impairing that we test for, but there's difficulty 1
in evaluating whether it's legitimate. "Legitimate 2
use," what does that mean? And there's a lot of 3
back-and-forth in the federal agencies about that.
4 But what is a legal prescription?
5 We don't have any information about 6
what is a valid prescription. What Part 26 does do 7
is it defines what an illegal drug is. And I just 8
want to read this real fast, and then, we'll move 9
on.
10 An illegal drug is "any drug that is 11 included in Schedules I to V of section 202 of the 12 Controlled Substances Act
[21 U.S.C. 812]"
13 that's the CSA that was referred to previously --
14 "but not when used pursuant to a
valid 15 prescription" -- I underlined that for emphasis --
16 "or when used as otherwise authorized by law."
17 So, the valid prescription is really 18 important, but we don't define what that is. DOT, 19 as I highlighted before, has come up with some 20 information to enable their MROs to understand what 21 that means.
HHS has some really valuable 22 information in their MRO manual that came out in 23 their 2020 manual.
24 That provides information for MROs 25
93 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com about what's a valid prescription; how do you 1
validate a prescription? Is a picture of the 2
bottle okay that the donor provides to you? Do you 3
need to talk to the prescribing physician? What 4
kind of record from a pharmacy might be beneficial, 5
right?
6 So, there are a variety of ways you can 7
validate that a prescription is legitimate; that an 8
individual is using it correctly. Is it an expired 9
prescription? Are they taking too much of a 10 prescription? So, it's a complex topic.
11 Part 26 has zero information in there, 12 and we really need to improve that. And we have 13 some really good sources to look at and to, 14 hopefully, benefit the program in that area.
15 The other piece that I
think is 16 important is subversions. We were talking about 17 that. I already talked about that in a great level 18 of detail; that there are a couple of different 19 result reviews that the MRO is front and center, 20 and they're making subversion determinations. And 21 we do not have information in our rule that is 22 supportive right now of those decisions, or at 23 least uniformly supporting those decisions. So, 24 those are the two pieces there.
25
94 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Random testing. There's a couple of 1
areas that have come up over time where I think we 2
might be able to benefit from clarifications to the 3
existing requirements.
4 Reporting to the collection site. You 5
know, if you get notified to report for a test, how 6
much time is appropriate? You have to test on 7
weekends, backshifts, and holidays. Well, how many 8
weekends do you have to test at that's appropriate?
9 Our rule doesn't say. If you test one time in a 10 year, is that appropriate? We've had questions 11 like that come up in inspections.
12 Random testing is the other piece.
13 Once someone is granted unescorted access, that's 14 defense-in-depth.
We're verifying that that 15 individual is not using substances that we 16 prohibit, and we need to be effective in making 17 sure that folks don't know when we're testing them 18 and they have the reason to believe they're going 19 to get tested anytime they're at work.
20 And then, the last piece is about 21 random testing pools and rates, and whether it's 22 appropriate to manage that at a site-specific level 23
- a reactor level, or at a fleet level. There's 24 been a bit of variability there. I think it's an 25
95 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com area that we should be a little clearer on in the 1
rule.
2 Laboratories. HHS labs, required to 3
use them. Last rulemaking, we took a couple of 4
requirements off the table because the 5
certification process and the inspection process 6
from HHS reviewed those. No reason for us to look 7
at something that's already being reviewed by HHS.
8 We took them off the table. Are there other areas 9
that we can take a look at?
10 We had a question come in about sharing 11 of auditing records and access to auditing records, 12 and we put that in there. We could probably 13 benefit from improving that one particular element 14 of it.
15 Licensee testing facilities.
No 16 utility uses a licensee testing facility anymore, 17 as of 2023. Back in 1990, many of the utilities 18 used them. And why was that? Basically, it was 19 they were testing specimens onsite using testing 20 equipment, and it was beneficial at that time 21 because they could turn around negative results 22 quickly and grant unescorted access. And that 23 savings is money for outages.
24
- Nowadays, HHS-certified laboratories 25
96 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com turn around results, negative results, in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, 1
Express Mail, and all that good stuff. And all the 2
sites have moved away from using licensee testing 3
facilities.
4 And also, there's complexity to what we 5
do. Back in the day, in 1990, it was a little bit 6
simpler. Now, we're looking at other specimens to 7
test. We're looking at expanded panels.
8 And the cost involved. You know, what 9
we've heard is that there was a cost savings in 10 using the HHS-certified labs versus an LTF.
11 So, there is some consideration.
12 Should we eliminate LTF use from our requirements?
13 Reporting. I talked about this earlier 14 as well. At the front of the presentation, we 15 talked about how we get information and evaluate 16 performance. One way is, annually, we collect 17 information. Another way is we get more timely 18 reports if it's a significant type of an event. We 19 get 24-hour event reports. That's the first bullet 20 here, 26.719, 24-hour reports.
21 There's required reports for -- say, 22 for instance, a licensed reactor operator violates 23 the FFD policy. We get a 24-hour event report.
24 Information is provided by the licensee. This 25
97 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com information is publicly available under the event 1
reports, the agency event reports. So, the public 2
is aware of these events. We take action on these 3
events if we believe it's appropriate.
4 What we've seen is there's variable 5
levels of information being provided that may not 6
be sufficient for us to understand what the event 7
was. And so, the information here is just, 8
basically, suggesting we may need to clarify a bit 9
of what we need to get in these reports to be sure 10 we have enough information to determine whether we 11 need to take action or not.
12 The annual reporting reports.
We 13 collect information on an annual basis. There are 14 a couple of pieces of information that would be 15 beneficial to the program. They're risk-informed.
16 Two of them I call out.
17 One is pre-access testing reason. The 18 reason why that's a helpful piece of information is 19 because some people we grant unescorted access to 20 before we get a negative result. And those are 21 individuals that have been in the program recently.
22 We'd like to know that piece of information. If 23 someone's testing positive and we've granted them 24 unescorted access, it's a little bit different than 25
98 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com if somebody never had unescorted access until we 1
get a negative result.
2 So, many sites already provide it.
3 It's optional in the forms. These two fields are 4
optional at this point. Maybe we need to make sure 5
that we get that information uniformly, so we can 6
do better risk-informing of a few policy positions.
7 Out-of-scope comments.
I briefly 8
talked about that. We have a number of them. We 9
highlighted some of them here:
10 Gender identity.
So, we've had 11 questions in terms of an individual's gender 12 identity and where does this play out in terms of 13 Part 26. The gender of the individual is important 14 when we talk about an observed collection. We've 15 had questions related to that topic.
16 Other
- topics, other questions or 17 comments we received were related to post-event 18 testing criteria. So, you're required to do a test 19 under certain circumstances.
20 Behavior observation program elements.
21 I already talked about behavior observation. It's 22 one of the defense-in-depth measures that we employ 23 when someone is granted unescorted access and we're 24 looking for aberrant behavior. A comment on that.
25
99 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Performing medical evaluations.
I 1
think that one ties to shy bladders, and if 2
somebody can't produce urine in a timely manner, 3
how do we go about getting a medical evaluation 4
when we have a very limited clock?
5 Alternative specimens.
That one 6
comment was saying, hey, can you use oral fluid in 7
other circumstances such as a shy bladder.
8 Tony?
9 MR. BOWERS: Yes, Brian I was just 10 going to -- we only have 10 minutes left.
11 MR. ZALESKI: Right.
12 MR. BOWERS: Can we open this up for 13 any public comments?
14 MR. ZALESKI: Yes, that's the last 15 slide. That was the last slide. We can move on.
16 Go ahead.
17 If anybody would like to offer a 18 question or a comment, I'm going to look at the 19 comment box. I don't know if -- Johnny, go ahead.
20 MR. ROGERS: Brian, I have a list here.
21 We don't have to spend a lot of time debating. I 22 just want to make sure that we get the topics 23 listed, so that we can consider them.
24 MR. ZALESKI: Yes.
25
100 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. ROGERS: Face-to-face evaluations, 1
you mentioned those and DOFs. I think better 2
clarity in the definition of "for cause" there; it 3
doesn't match other sections of the rule. So, we 4
want to make sure we're looking at that.
5 SAEs, you mentioned them. We know that 6
there are individuals with advanced substance abuse 7
counseling and training and diagnosis and 8
treatment, or what have
- you, that are 9
administrators of programs.
We think it's 10 appropriate to consider those in our program as 11 well. So, that's a consideration for SAEs.
12 26.41, "Consideration for Audits," for 13 a two-year frequency for vendor programs, as 14 opposed to one. We think that has merit. We'd 15 like to take a look at that.
16 MR. ZALESKI: And when you say, "vendor 17 programs," can you explain what that means a little 18 bit more?
19 MR. ROGERS: Well, as defined in 26.41.
20 So, any program that vendors are serving that are 21 brought into the FFD program, and anybody under 22 that category, you know, we are required to audit 23 every two years -- or every year. We want to look 24 at a two-year frequency. We do that for our own 25
101 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com programs. We want to include the vendors.
1 MR. ZALESKI: Okay.
2 MR. ROGERS: 26.719, "Supervisors in a 3
Non-Safety Position," under reporting for 26.719, 4
we would -- and I know you're aware of that because 5
we've talked about it before.
6 MR. ZALESKI: Now, that one I had. You 7
have it on the slide, and that one, I just want to 8
say that is within scope of another rulemaking that 9
is with the Commission right now. There's a 10 rulemaking plan with the Commission. It's called 11 the RROAR effort.
12 MR. ROGERS: Right.
13 MR. ZALESKI: -- I can't remember.
14 MR. ROGERS: Yes.
15 MR. ZALESKI: And that one is with the 16 Commission. The rulemaking plan is with the 17 Commission. That is already on the docket for that 18 rulemaking to look at the supervisor category for 19 reportability and to tie it to safety-and 20 security-related oversight functions versus just 21 supervisor of the maintenance crew that's cutting 22 grass, right?
23 MR. ROGERS: Very good.
24 MR. ZALESKI: So, that one's already --
25
102 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. ROGERS: Yes, that's the one.
1 MR. ZALESKI: That's already in play 2
and already in process independent of what we're 3
doing here. Okay?
4 MR. ROGERS: Okay. 26.719, "Confusion 5
on Significant Program Violations,"
the word 6
"significant program violation" is sort ambiguous.
7 We'd like to take a look at that, if we could.
8 MR. ZALESKI: Yes.
9 MR. ROGERS: Additionally, you already 10 talked about gender.
11 26.69, "Greater Flexibility in 12 Assigning Follow-up Recommendations for SAEs," we'd 13 like to think about that and talk about that a 14 little bit.
15 MR. ZALESKI: Can you say a little bit 16 more about that at a high level? I mean, I don't 17 want to rush you.
18 MR. ROGERS: Well --
19 MR.
ZALESKI:
We can have a
20 conversation for a few more minutes.
21 MR.
ROGERS:
The Code is really 22 nondescript here with respect to assigning follow-23 up recommendations. You know, if an SAE wants to 24 assign monitoring for a week or for 30 days or for 25
103 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com 10 days, the rule is kind of nondescript. And 1
maybe it's designed that way. Maybe that's okay.
2 But we sort of get into problems with 3
PADs when we only have one designation for a 4
program violation. So, not to get too far into the 5
weeds here, but some SAEs are recommending three 6
years, 15 tests, you know, for a single DUI.
7 That's not the intent of the --
8 MR. ZALESKI: Right. You're talking 9
about, yes, you're talking about individuals that 10 are in follow-up testing not because of a violation 11 under Part 26, but because of an external event or 12 an external issue, right, that they are subject to 13 follow-up testing?
14 MR. ROGERS: And to be fair, you know, 15 there's a little ambiguity in the rule. So, maybe 16 a little bit more guidance with respect to follow-17 up, is all I'm saying.
18 MR. ZALESKI: Yes. No, that's helpful.
19 MR. ROGERS: Good.
20 26.89, Collector Instructions, asking 21 versus instructing -- it's just a verbiage issue, 22 but it's not clear and we're running into audit 23 issues there.
24 MR. ZALESKI: Yes.
25
104 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. ROGERS: 26.93, provide greater 1
clarification for written and oral instructions.
2 Again, a verbiage issue, but, again, spelling out 3
4 MR. ZALESKI: So, you're talking about 5
mandated statements that we have to ask the donor 6
and to affirm that they received the information, 7
et cetera, during the collection process? Is that 8
sort of the areas we're talking about?
9 MR. ROGERS: Yeah, that's sort of the 10 area I'm talking about.
11 MR. ZALESKI: Right. Yes. Got you.
12 MR. ROGERS: 26.109, Acceptability of 13 Urine Specimens. We've got some verbiage issues 14 there we'd like to clean up.
15 MR. ZALESKI: Okay.
16 MR. ROGERS: 26.117, Preparing Drug and 17 Alcohol Specimens for Storage and Shipping.
18 Greater clarity when the specimen is sealed versus 19 out of view of the collector. So, a little work 20 there. We're seeing some audit issues there we 21 would like to clean up.
22 26.163, Flexibility in Drug Panel 23 Expansion. I think we've covered that one already.
24 26.205, Fatigue. We'd like to talk 25
105 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com about fatigue on a general basis, and I think the 1
fatigue folks, I'm going to be engaging them with 2
more dialogue. But we want to get that on the 3
docket for consideration.
4 26.713, Recordkeeping.
Review of 5
language for consistency and clarity. There's some 6
language in 26.713 I think we can do a little 7
better job with.
8 MR. ZALESKI: Okay.
9 MR. ROGERS: And that's the end of my 10 list.
11 Thank you for listening.
12 MR. ZALESKI: You have at least four 13 minutes, or other people have at least four 14 minutes, but I'm happy to entertain additional time 15 to make sure people can ask questions. There was a 16 lot. There was a lot to talk about.
17 I
appreciate all that information, 18 Johnny. That's very helpful.
19 Let me double-check the comment box, if 20 there's anything in here.
21 I don't know if anybody has seen 22 anything. Stew, have you seen anything in here?
23 Okay, let's see.
24 MR. SCHNEIDER: No, I did not, Brian.
25
106 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. ZALESKI: Okay.
1 MR. ROGERS: Brian, this is Johnny. I 2
do see one comment I think from Larry Sweeney.
3 MR. ZALESKI: Yeah, and I see Matt.
4 Matt has just raised his hand. Okay.
5 Extending periodicity on audit 6
requirements for labs due to HHS cert, DOT, et 7
cetera.
8 I don't know, Larry, if you're on and 9
you want to elaborate more about that comment or 10 not. It's okay if you don't. You provided it.
11 Matt, why don't you go ahead? And 12 then, Larry, if Larry's on, he can circle back 13 after Matt.
14 MS. BOND: Brian, this is Tammy Bond.
15 MR. ZALESKI: Oh, okay.
16 MS. BOND: I think Larry's comment is 17 tied to what Johnny had already indicated about 18 audit frequency.
19 MR. ZALESKI: Okay, right, two years 20 versus --
21 MS. BOND: Yes.
22 MR. ZALESKI: Yeah, I got you. Okay.
23 MS. BOND: Yeah.
24 MR.
ZALESKI:
- Thanks, Tammy.
25
107 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Appreciate that.
1 Okay. You're on, Matt.
2 MR. DEIGNAN: Hey, Brian, this is Matt 3
Deignan from Entergy.
4 I've got two. I know you briefly 5
mentioned it, but one of them is going to be, like, 6
the 26.185(j)(1). It's really for the MRO, like to 7
distinguish between abuse and misuse.
8 MR. ZALESKI: Yes.
9 MR. DEIGNAN: And then, 26.185(j)(1),
10 that we have an (i.e., morphine and/or codeine).
11 And that i.e. was supposed to be examples, but that 12 clarification, as we discussed in the past, is 13 really only tied to those two drugs. So, just to 14 try to get a clarification on that.
15 MR. ZALESKI: Yeah, you're talking 16 about clinical evaluations of abuse and we're 17 talking about medicines and misuse provisions of 18 the rule for 26.185, right? Yes?
19 MR. DEIGNAN: That is correct.
20 MR. ZALESKI: Right. And, yes, that 21 was one topic I didn't drill into, but, clearly, a 22 lot of that ties to legitimate medical use, a valid 23 prescription, and then, the misuse topic, right?
24 Yes, that's front and center, and thank 25
108 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com you for that feedback for sure.
1 MR. DEIGNAN: All right. And then, my 2
second one, again, it would be on 26.165(f) on 3
management sanctions. Actually, the sanctions.
4 When we have an individual that's 5
denied, and then, the individual will ask for a 6
retest, the rule says to administratively withdraw 7
that access.
8 MR. ZALESKI: Right.
9 MR. DEIGNAN: I guess I'm just trying 10 to get a
clarification.
Why would we 11 administratively withdraw them when we've already 12 denied them? And then, obviously, if the results 13 came back from the MRO negative, we would take that 14 process to remove that denial. Is there a way, 15 just for clarification, of removing that wording of 16 administratively withdrawing?
17 MR. ZALESKI: Right. So, we require, 18 if somebody has a confirmed positive, adulterated, 19 or substituted test result, the MRO gives that 20 individual the opportunity to have that specimen 21 sent to another laboratory to independently verify 22 the result.
23 So, if that happens, the first result 24 is confirmed. So, that's a testing violation.
25
109 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com But, at a minimum, you need to administratively 1
pull the access for that individual, because it's a 2
legitimate result until we know otherwise, and 3
verify by a second laboratory.
4 So, the requirement is, basically, to 5
ensure that somebody's not maintaining access when 6
they already have a valid result from an initial 7
laboratory, right? That's what the basis for that.
8 If we can improve the language in there 9
to make sure it's clear enough, then -- and I 10 understand what you're saying. You know, we 11 already terminated that individual, or denied 12 access or terminated their access, because they 13 have a violation, right? That's what you're 14 saying?
15 MR. DEIGNAN: Correct, Brian, that's 16 what I'm saying, yes.
17 MR. ZALESKI: Yeah, I got you.
18 MR. DEIGNAN: Okay.
19 MR. ZALESKI: Okay? Yes, sure, I want 20 to make sure folks have an opportunity.
21 Is there anybody else that would like 22 to offer a comment? I'm happy to give you another 23 minute or two to think about it, because I started 24 the meeting three or four minutes late to give 25
110 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com people an opportunity to call in. So, I'm happy to 1
extend the meeting by two or three minutes, or four 2
minutes, to make sure we can accommodate anybody 3
else's question.
4 (Pause.)
5 MR. ZALESKI: So, I will say I do 6
appreciate everybody's time. You know, there are a 7
lot of people that called in and they have very 8
busy schedules. And I know that this is an 9
important topic for a lot of people and there are a 10 lot of ideas out there, and we only covered some of 11 them in this conversation.
12 This is the first conversation. This 13 is the start of this process. What we're trying 14 to do is make sure we have the key reasons why we 15 think it's appropriate to move forward with 16 rulemaking, and make sure that, if there are areas 17 that industry or the public believes is appropriate 18 for consideration, and that we should provide to 19 the Commission when we develop our plan, you know, 20 that's what this meeting is about. But this is the 21 first conversation amongst many of them. So, I 22 hope everybody understands that.
23 I just want to emphasize again that we 24 will offer a summary of this meeting, you know, a 25
111 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com high-level summary, but we will also have a 1
transcript of this meeting, so you can read through 2
all of the conversation that we had, if you missed 3
a particular topic.
4
- Finally, I
want to make sure I
5 emphasize that, again, these slides are publicly 6
available right now on the public meeting website.
7 Almost all the links in there are interactive, so 8
that you can select the link. Anything that is 9
blue and is underlined, you can get the document or 10 you can go to the specific requirement. And if 11 that helps you take a look at what we're talking 12 about -- I just wanted to make sure you're aware of 13 that. They're all active in that document.
14 And then, again, you also know how to 15 find out more information about this rulemaking 16 from the NRC resources that we provided at the 17 start.
18 So, I want to thank you all for your 19 participation today. And thank you again for the 20 successful implementation of the 2022 final rule.
21 You know, we're now in new regulating space in 22 terms of that rule being in place, and I look 23 forward to additional opportunities in the future 24 to engage on how we can make this rulemaking or 25
112 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com rule better.
1 Tony, do you have anything you want to 2
offer up?
3 MR. BOWERS: No, Brian. Thank you.
4 MR. ZALESKI: Okay. Stew, is there 5
anything? Stew, is there anything we need to offer 6
up?
7 Oh, contact information, just in case 8
you want to call us or email us. But, again, this 9
conversation today was targeted to this particular 10 aspect. We're not asking for feedback outside of 11 this meeting.
12 Members of the public can always engage 13 with us under any circumstance. And we provide our 14 information here or resources to talk to about the 15 program. And so, that's what we have here, our 16 contact information.
17 And we thank you --
18 MR. SCHNEIDER: And also, there should 19 be a link on the announcement that permits the 20 public to provide feedback on the conduct of 21 today's meeting.
22 MR. ZALESKI: Yes.
23 MR.
SCHNEIDER:
This is Stewart 24 Schneider, Rulemaking Project Manager.
25
113 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. ZALESKI: Yes, let me pull that up 1
real fast. So, on the public meeting website --
2 this would be great if folks want to provide 3
feedback -- always a good thing.
4 So, again, on the main NRC website, you 5
scroll down to Public Meetings. If you click on 6
today's date, which is February the 7th, and you 7
select Fitness for Duty Meeting, and there's a 8
little bracketed -- oh, no, actually, you don't 9
even have to go that far.
10 It says Meeting Feedback Form. If you 11 click that link it will provide you the opportunity 12 to rate this meeting and provide feedback about 13 things that were beneficial to you or maybe we can 14 improve in the future. Any feedback is welcomed.
15 I certainly want to improve my job if 16 there are things that I need to improve on, and I 17 appreciate any feedback that you provide that what 18 we provided today is beneficial, so that we can 19 continue to do it in the future.
20 And with that, I will conclude the 21 meeting and thank everybody for their 22 participation, and wish you all a good rest of your 23 week. Thank you.
24 (Whereupon, the above-entitled matter went off the 25
114 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com record at 3:05 p.m.)
1