ML20205B923
| ML20205B923 | |
| Person / Time | |
|---|---|
| Issue date: | 03/25/1999 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 9904010030 | |
| Download: ML20205B923 (102) | |
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C-A DISCLAIMER This is an unofficial transcript ~of a meeting of the United States Nuclear Regulatory Commission held on March 25, 1999, in the Ccemission's office at One White Flint North, Rockville, Maryland.
The meeting was open to public attendance and observation.
This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies.
The transcript is intended solely for general informational purposes.
As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed.
Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs.
No pleading or other paper may be filed with the Commission in any proceeding as the result of, or addressed to, any statement or argument contained herein, except as the Commission may authorize.
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'l UNITED STATES OF AMERICA 2
NUCLEAR REGULATORY COMMISSION 3
4 OFFICE OF THE SECRETARY l
5 6
BRIEFING ON PART 35 RULEMAKING 7
8 PUBLIC MEETING 9
10 One White Flint North 11 F ts - 1F-16 12 11555 Rockville Pike 13 Rockville, Maryland 14 Thursday, March 25, 1999 15 l
16 The Commission met, pursuant to notice, at 1:36 17 p.m.,
the Honorable SHIRLEY A. JACKSON, Chairman of the 18 Commission, presiding.
19 l
20 COMMISSIONER'S PRESENT:
21 SHIRLEY A. JACKSON,. Chairman of the Commission 22 NILS J. DIAZ, Commissioner 23 GRETA J. DICUS, Commissioner 24 EDWARD McGAFFIGAN, JR., Commissioner 25 JEFFREY S. MERRIFIELD, Commissioner l
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STAFF AND PRESENTERS SEATED AT'THE COMMISSION TABLE:
2 MAL KNAPP, EDO 3
CARL PAPERIELLO, NMSS i
4 DONALD COOL, NMSS 5
JUDITH ANNE STITT, M.D.
7 DENNIS SWANSON, MS.,
B.C.N.P.
8 MANUEL D. CERQUEIRA, M.D.
9 RUTH MCBURNEY 10 LOUIS K. WAGNER, PH.D.
.11 12 13 14 15 16 17
'18 19 20 21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD.
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PROCEEDINGS 2
(1:36 p.m.)
3 CHAIRMAN JACKSON:
Today, the NRC staff and the 4
NRC Advisory Committee on the Medical Uses of Isotopes will 5
provide the Commission with a briefing on radiation l
6.
protection issues associated with medical uses of 1
radioactive materials.
The ACMUI, as the advisory committee 7
8 is called, last met with the Commission in June, 1998.
Much 9
has happened in the last year.
10 In June 30, 1997, staff requirements, the l
= 11 Commission approved the staff's plan for revision of both 10 I
l 12 CFR Part 35 and the Commission's medical use policy 13 statement.
The staff has proceeded in an expedited manner 14 to develop the proposed rule over the last two years.
The 15 process to revise Part 35 and the associated guidance
.16 documents have provided additional opportunities for input 17 from interested parties on the Commission's rulemaking.
The 18 staff has held multiple meetings with the public and 19 professional societies and boards, and met extensively with
~
20
-ACMUI and members of its subcommittees.
21 Today, the staff will brief the Commission on the 22 status of these activities, focusing on the most significant 23z issues associated with the proposed revision of 10 CFR Part 24 35 and what it's going to require to come to closure on that 25 and the medical policy statements.
The ACMUI presentation i
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will follow that of the staff.
2 And I'll ask my colleagues if they have anything 3
to add.
Dr. Knapp, would you please proceed.
4 DR. KNAPP:
Thank you, Chairman.
As you said this 5
afternoon, we will be briefing you on the work that's been 6
.done on Part 35.
You have at the table to my right, Dr.
7 Donald-Cool; to my left, Dr. Carl Paperiello; and to his 8
left, Catherine Haney.
Dr. Paperiello and Catherine Haney 9
will be doing the principle part of the briefing for the 10 staff. 'Afterwards, you will be briefed, as you said, by the 11 ACMUI,.who are seated behind us.
To my far right, we have 12 Dennis Swanson; to his left, Dr. Judith Stitt; to her left, 13 Dr. Louis Wagner; to his left,. Ruth McBurney, representing 14 the State of Texas; and to her left, Dr. Manuel Cerqueira.
15 And with that, I would like to turn it over to 16 Carl for the initial part of the briefing.
17 DR. PAPERIELLO:
Good afternoon.
This is in 18 response to a Commission request that the staff brief the 1
19 Commission on the status of the Part 35 rulemaking, and I 20 would note that the staff has not provided th'e Commission 21 with the paper to support this briefing.
22 We did want to discuss -- can I have the first 23 slide?
Next slide.
We did want to discuss a~ handful of
.24 issues associated with the rulemaking for which the 25 Commission may wish to provide further guidance to the i
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staff, and also describe where the staff stands in bringing 2
a final rule to the Commission.
3 Next slide.
I would note that the -- we have as a 4
primary objective of the rulemaking to have a risk informel 5
performance-based rule focused on the management component l
6 of the existing rule on its essential requirements.
Now, I l
7 think the proposed rule represents a significant decrease in 8
the requirements in the quality management rule, and even a l
9 larger decrease in-its prescriptiveness, and to have a rule 10 that explicitly provides for new modalities.
11 Could I have the next slide?
12 CHAIRMAN JACKSON:
When you say patient safety, 13 what do you mean?
l 14 DR. PAPERIELLO:
I mean ensure that the patient
.15 receive the dose that the doctor prescribed or directed, as 16 the case may be.
17 Secondarily, we wanted to-add certain new 18 modalities, such as remoce Brachytherapy, after loaders, and 19
. gamma stereotactic radio surgery.
The latter is commonly 20 known under the brand name of Gammanyte, which is the most 21 widely'known brand.
We would allow inpatient visitors to 22 receive up to 500 millirem.
And this is increased, so that i
23 a 100 millirem public dose limit is in accordance with 24-international standards, which consider this type of 25 exposure a medical exposure.
Licensees will also have to l
l
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determine Brachytherapy's output activity prior use.
We 2
could rely on vendor or manufacturer measurements.
And we 3
believe we've also reduced significantly the record-keeping 4
burden in the proposed Part 35.
5 Next slide.
6 CHAIRMAN JACKSON:
Let me ask you a question here.
7 Is the 500 millirem dose related to grandfathering old 8
facilities?
Or is related to having family and friends 9
provide additional --
10 DR. PAPERIELLO:
It's family and friends.
In the 11 international standard arena, the dose to care givers, 12 including people who provide emotional support to patients, 13 is considered medical exposure.
And for those individuals, 14 the recommendation is a 500 millirem, because it's generally 15 understood this is not a year in and year out occurrence.
16 This is probably occur once or twice in a lifetime.
17 MR. MCGAFFIGAN:
Madam Chairman?
18 CHAIRMAN JACKSON:
Yes.
19 MR. MCGAFFIGAN:
My recollection is that this --
20 the University of Cincinnati had given us a petition in this 21 area that we just folded into this rulemaking.
22 DR. PAPERIELLO:
Yes.
Can I have slide four?
23 Although we believed the staff in the stakeholder's group 24 generally converged on this rule, some individuals continue 25 to assert that we should abolish Part 35 and stop regulating i
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the use of atomic energy act material by medical users or to 2
limit the regulations solely to Part 20 and training and 3
experience requirements.
Some stakeholders want a formal 4
quantitative risk assessment for the rule and want the NRC 5
to grant a general license for diagnostic nuclear medicine.
6 MS. DICUS:
Madam Chairman?
7 CHAIRMAN JACKSON:
Please.
8 MS. DICUS:
Question.
The distinction between 9
risk informed versus a risk-based rule, do you think that 10 among wide range of stakeholders, there's a clear 11 understanding of the difference between those two?
12 DR. PAPERIELLO:
Cathy, could you --
13 MS. DICUS:
I love being greeted with silence.
14
[ Laughter.]
15 MR. MCGAFFIGAN:
Pass the buck to the lowest 16 level.
17 OHAIRMAN JACKSON:
I don't know if Cathy wants to le be called the lowest level.
19.
[ Laughter.)
20 MS. HANEY:
I would say that there is some 21 misunderstanding in the community.
I know it's been a topic 22 at several of the public meetings, and we have exp'lained it 23 very often.
But.to give you an example, it wasn't until the 24 last meeting, which would have been about the eight of a 25.
series of meetings, that someone came up to me and said, f
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well, you know, now for the first time, I understand what 2
the difference is.
So, I think to answer your question, 1
3 yes.
4 CHAIRMAN JACKSON:
So, you've iterated to these 1
5 people to explain --
6 MS. HANEY:
Yes.
7 CHAIRMAN' JACKSON:
-- the difference?
8 MS. HANEY.
We have tried very hard.
9 MS. DICUS:
One other thing, if we could, just l
10 real quick:
this lack of a formal risk assessuent that is 11 bandied about so much, does the staff -- how does the staff 12 propose to respond to the ACNP and the Nuclear Medicine 13 Association on that issue, or do you plan to re. pond?
14 CHAIRMAN JACKSON:
How do you come with these l
15 questions?
16 LR. PAPERIELLO:
I would like to respond to it, 17 and it's -- the question right now is a question of time.
I 18 have convinced my -- in my own mind, I -- in fact, I've done 19 my own informal risk assessment.
And as I would get to --
20 in fact, if I could have the next slide.
Let me -- if you 21 look at the empirical occupational basis of nuclear 22 medicine, the workers, if you look at.the potential public 23 doses, and.if you take-a look at the need to ensure that 24 medical doses are directed by a knowledgeable physician, and 25 I think you could justify the fact that you need a specific ANN RILEY & ASSOCIATES, LTD.
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license.
General -- you would now allow general licensees 2
to have exposures in the order of a rem or two a year, and 3
some nuclear medicine technicians get exposures this high.
4 It's above the point where you need badging.
You need to 5
give people Part 19 training.
6 If the material used would consistently go astray, 7
then you could have public doses in excess of the public 8
dose limit.
An occasional error, either in 9
misadministration or an occasional unit dose going astray, 10 will not create a societal risk that is unacceptable.
I'm 4
11 defining that as 10 to the exposed -- you know, to the 12 potentially exposed population.
You need systematic'-- you 13 need systemic breakdown to have a problem.
And that is the 14 basis, I believe, of risk informed performance-based 15 regulation.
There needs to be a program, but an occasional 16 lapse will not create an unacceptable risk.
17 So, I think that kind of analysis bounds this.
18 Ycu need a specific license.
But, we have got to, and we 19 have -- I believe when you look at the rule and what 20 actually is requi' red in diagnostic medicine, there are very 21
-- relatively few requirements and most of them deal with 22 Part 20, with the exception that the people, who use the 23 material, have -- and this.is an area where we're not going 24 to get any argument, with proper training and experience, 25 and you need to know that you're giving a patient a dose, ANN RILEY & ASSOCIATES, LTD.
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and it just doesn't happen inadvertently.
2 But other than that, there are no -- then there's 3
a handful of requirements, which relate to Part 20, You 4
have to have survey instruments.
You have to keep record of 5
doses.
You have to have a radiation safety officer.
You 6
know, if you have to have a program, we're not going to tie 7
the program down on a license.
They are going to be able to 8
make changes tnat you want to make.
I mean, I think that 9
we've done a good job in abolishing unneeded requirements 10 and having a truly performance-based program.
11 MS. DICUS:
Thank you.
12 DR. PAPERIELLO:
Cathy, I'll turn the rest of the 13 presentation over to you.
14
-[ Laughter.]
15 MS. HANEY:
Okay, thank you, Carl.
Good 16 afternoon.
I would start with slide six.
And, basically, 17 just to recap briefly the actions that the staff has taken 18 since the June briefing, the key notes to note -- the key 19 things to note on this particular slide is that we did hold 20 four facilitated public meatfngs during the comment period.
21 Three of them are meetings that we convened.
The fourth one 22 was during the all agreement state r,eting, where we held a 23 workshop with the agreement states.
So, there was some 24 focus on that meeting with regards to the agreement state j
25 issues.
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The comment period for the rule closed on December 2
16th.
We received approximately 225 comments on the rule of 3
medical policy statement and the guidance, When you take 4
these particular documents and put them all rogether, it 5
comes up with about 900 pages of text tha*. the staff has to 6
respond to, as a result of the rule being published.
7 MR. MCGAFFIGAN:
Could I ask a clarifying -- what 8
do you consider -- I sat in on parts of the Rockville 9
meeting in October, and lots of people s' making comments 10 in the course of the meeting.
And I recall some; I'll come 11 back to them later.
But, are those comments on the rule, if 12 they're spoken at a facilitated public meeting --
13 MS. HANEY:
Yes.
14 MR. MCGAFFIGAN:
-- that you have to analyze?
15 MS. HANEY:
Yes, they are.
16 MR. MCGAFFIGAN:
Gosh, I could have counted more 17 than a handful at Rockville alone.
So, I'm surprised it 18 says a few.
Nine-hundred pages doesn't surprise me.
The 19 200 comments, you must have done some amalgamated --
20 MS. HANEY:
Well, the 200 comments were actually 21 letters.
So within those letters, there were --
22 MR. MCGAFFIGAN:
Oh, okay.
23 MS. HANEY:
-- they could have been, you know, 24 10-15 page letters.
In the case of transcripts, we were 25 looking at probably about four or five inches of paper for ANN RILEY & ASSOCIATES, LTD.
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each transcript.
And that's really what was handed up --
2 MR. MCGAFFIGAN:
That's the 900 pages?
3 MS. HANEY:
-- as being the 900 pages.
4 MR. MCGAFFIGAN:
Okay.
And there's one question I 5
want to ask, if I could, at this point.
Prior to the time 6
period here, we had tried to do some extraordinary things to 7
make this rulemaking go smoothly, once the proposed rule 8
went out.
I think it was June of 1997, we had a briefing 9
here with ACMUI and the staff, and we made some final 10 decisions then about how the structure of the rule might 11 look like, etc., following that meeting.
And then since 12 nobody else was drafting, you guys put something out on the 13 Web page, my recollection is probably September, October of 14
'97.
15 But the complaint we have gotten is that it was a 16 one-way communication during that period between, if I'm 17 right, October, '97 and June,
'98, that people -- it was ouc 18 there, people were commenting on it, that we weren't 19 commenting back.
And it's -- in proximity, we're a learning 20 organization.
In proximity, at the moment,.in the 21 pre-proposed rule period, you're having very active 22 communications.
If you had this to do over, and we don't, 23 would you have used that period between October of '98 and
\\
24 June of -- October, '97 and June of '98, differently?
Would 25 there have been more active meeting and communicating back ANN RILEY & ASSOCIATES, LTD.
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1 to the commenters, as to what'our views were on the comments 2-and all that?
3 DR.-PAPERIELLO:
I could say, yes, which would 4
probably be a popular answer.
I would say we could have f
5 probably done some more.
But the time constraints on all 6
this are a problem.
You know, you just -- there's so much 7
you can do within the time you have.
And if you have more 8
public interactions, you're, obviously, listening and you're 9
.not writing.
So, I mean, there's been -- this is a big rule 10 and it's just so many things -- you have so much time --
11 when you have a time constraint, there's just so much you 12 can do.
13 We probably could have done more.
On the other 14 hand,-you know, this is the first time we actually tried to if write a rule on the Web.
And we were trying -- we expected 16 a lot more feedback than maybe we got.
We've got to learn 17 how to use that interaction.
11 8 CHAIRMAN JACKSON:
So, you're arguing'that, in l
19 fact -- I mean, I remember when the whole construct was laid 20 out and the idea of doing this. expedited rulemaking.
And 21 that by.doing it on the Web, it would allow you to cut down 22 on the time, and that had something to do with the proposed 23 time frame.
And so, the question is, in terms of lessons 24 learned, what happened?
Because, it was presented to the 25 Commission as an expedited rulemaking and that we could ANN RILEY & ASSOCIATES, LTD.
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expedite it by doing this way.
2 Dr. Cool, you were going to make a comment?
3 DR. COOL:
Two observations, I think.
The first 4
is that you always have the conundrum of getting something 5
that people can react to and then feeling like they're j
6 already behind the curve.
In this particular situation, 7
there was already word on the street, there was already a 8
lot of background information.
And I'm not sure to what 9
extent we may have been -- or would have been guilty of 10 that, irrespective.
11 The second, to get to the question which you 12 asked, was in writing this on the Web this first time, 13 particularly with the proposed rule, the staff erred, if you 14 will, in the direction of version control and not having too 15 many iterations going up too close together, to allow people 16
-- or allow, of course, to give people an opportunity to 17 react.to it.
18 In retrospect, we could have put additional 19 versions up and been more interactive.
But, it was one of 20 those learning exercises of attempting to -- how often do 21 you change something, when they just get around to getting.
22 it in?
They start to comment and' suddenly another version 23 pops up.
24 MR. MCGAFFIGAN:
Madam Chairman, I'm not -- I 25 think we have a lot to learn.
The thing that strikes me ANN RILEY & ASSOCIATES, LTD.
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about the staff on medical is we have a relatively modest 2
staff.
And on things like'5059, we can afford --
3 CHAIRMAN JACKSON:
You.have an army.
4 MR. MCGAFFIGAN:
We have an army, right.
We have 5.
an army to send out.
So, I'm not -- I recognize here it's a J
6 limited number of folks.
7 The other point I'd make, one of the troubles in 8
dealing with a rulemaking that's this comprehensive is some 9
things that will not -- we will not talk about today, 10 because they're not major; in a small rulemaking would be 11 major.
And, you know, it's -- there may well be a lot of 12 these 900 pages of comments that, if they had been off by 13 themselves, these fairly profound issues.that we would 14 struggle with, if we were bite size rulemaking.
So, it's --
15 but, we don't -- I know these folks are doing the best they 16 can'in a very complex area with very limited resources, 17 compared to those we throw at reactive rulemakings.
18 MS. HANEY:
Okay.
Slide number seven, I would 19 just like to tell you a little bit about the continued 20.
interactions that we've had with the stakeholders, since the 21 public comment period closed.
In February -- early 22 February, we had a facilitated public meeting with the 23 medical specialty boards and the purpose of that meeting was 24 to. discuss some of the implementation issues associated with 25 the training and experience requirements, if we were to ANN RILEY & ASSOCIATES, LTD.
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pursue what we had proposed -- what appeared in a proposed 2
- rule, 3
We, also, had two meetings in February with the 4
subcommittees of ACMUI.
The purpose for that was to prepare 5
for the meeting we've just concluded of the full committee 6
and to get some early input from the ACMUI abouc the staff's 7
proposed response to the comments.
l 8
Another interaction we had was last week,'I I
9 attended the conference of Radiation Controlled Program i
10 Directors SR-6 committee meeting.
This is a group that is 11 preparing equivalent medical rules for the suggested state 12 regulations.
And we are attempting to do a sort of parallel 13 rulemaking with the agreed -- with the CRCPD on this.
So, I 14 sat in on that meeting and we looked at the suggested state l
15 regs,.in light of where we were on March 15th with the 16 proposed rule, which is kind of a moving target for us.
17 And as I said, we just completed a full ACMUI 18 meeting at noon today.
And then, we've also continued to 19 have ongoing meetings with -- public meetings with the l
20 public, with Part 35 working group and steering group.
- And, 21 again, I'd just like to note here that on the working group 22 and steering group, we did have members of the agreement 23 states and Organization of Agreement State and CRCPD 21 representation.
So, we have been trying to work very 25
-closely with the states on development of this rule.
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'1 The next view graph, please.
There are a couple 2
of captions that I would like to bring to the Commission's 3
attention:
the training and experience, the reporting 4
requirements.
There are two reporting requirements that 5
we'll discuss in a few minutes.
Also, staff's proposed 6
response and dealing with comments on radiation safety 7
committee and then the calibration of Brachytherapy sources.
8 For the purpose of the presentation, what I'd like 9
to do is to briefly tell you what was in the proposed rule, 10 what the major comments were in this area, and then staf f's 11 proposed response and how we would proceed into the final 12 rulemaking.
13 CHAIRMAN JACKSON:
Now, are these key issues key 14 because of risk significance or because they represent the 15 departures from the proposed rule?
16 MS. HANEY:
They're key because of the risk.
17 Actually, this answer is yes to both of them.
They are 18 risk-based and, in some cases, they are departures from the 19 current Part 35.
But, I would like to point out they are 20 not the only issues that we're dealing with that are high 21 risk for this rulemaking.
As Commiss'ioner McGaffigan said, 22 there are some that I just have not chosen to bring to your 23 attention, at this point.
24 With regard to training and experierce, on view 25 graph number nine, with the proposed rule, the staff did ANN RILEY & ASSOCIATES, LTD.
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depart from the current Part 35, in that we wanted to focus 2
the requirements on radiation safety.
And I'll focus 3
specifically on the alternative path -- training pathways,
]
4 that being the ones that individuals that are not coming to i
5 us being Board certified.
In the case of diagnostic users, 6
we made a significant reduction in the training hours.
7 Currently, to become an authorized user for someone that 8
would be doing imaging and localization studies, they'd have j
9 to have 1,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training.
The proposed rule would 10 have only required 1,200 -- I mean, I'm sorry, 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />.
11 In the case of the therapeutic users, and this specifically 12 the device users, such as the teletherapy, the remote after 13 loaders, or the gamma seratactic reduced surgery units, we 14 maintained a status quo, and that being three years worth of 15 training.
16 With the significant reduction in the training 17 hours1.967593e-4 days <br />0.00472 hours <br />2.810847e-5 weeks <br />6.4685e-6 months <br />, we believe that it was necessary to have an exam that 18 would focus in on radiation safety.
It would be used to 19 assess the individual's knowledge of radiation safety.
We,
20 also --
21 MR. MERRIFELD:
Madam Chairman?
22 CHAIRMAN JACKSON:
Yes.
23 MR. MERRIFELD:
I'm sorry, I have a question for 24 purposes of clarification.
On slide nine, you say training 25 requirements for diagnostic users is significantly reduced.
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-Yet, when you turn forward, you have diagnostic uses -- I'm 2
sorry, slide 11, under the staff response, you have j
i 3
diagnostic users -- uses increase from proposed rule.
So,
'4 I'm just wondering --
5 MS. HANEY:
Sure.
6 MR. MERRIFELD:
-- you're reducing from what we 7
had before, but you're increasing it.from the original 8
proposal?
'It's unclear to me where we're going on that.
9 MS. HANEY:
Okay.
The current Part 35 requires 10 1,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />; the proposed rule would require -- stated 120 11 hours1.273148e-4 days <br />0.00306 hours <br />1.818783e-5 weeks <br />4.1855e-6 months <br />; and we're going to propose that the hours go back up 12 in the final rule to 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.
13 MR. MCGAFFIGAN:
Madam Chairman, can I --
14 CHAIRMAN JACKSON:
Please.
l 15 MR. MCGAFFIGAN:
-I can hear the endocrinologist at 16 the moment.
The training requirements were not reduced 17 significantly for endocrinologist using one isotope iodine j
18 and they complain that the 120 was a significant r tcheting 19
. upward on them, when there was no evidence of any problem.
20 And I hope you're'not going to be proposing you ratchet them 21 up to 700, because --
22 MR. HANEY:
No.
23 MR. MCGAFFIGAN:
Okay.
24 MR.'MERRIFELD:
As a_ follow-up question, one of 25
~ the things that we have said is, you know, we recognize that ANN RILEY & ASSOCIATES, LTD.
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the risks from diagnostic medicine are'less, and that's 2
certainly clearly the message from the users, that they've 3
been telling us.
I'm just wondering -- I'm wondering why 4
you decided to increase, having been at 1,200, you were 5
proposing 120, and now we're back up to 700?
Why the 6
differentiation in the area, which we have recognized as a 7
low risk?
8 MS. HANEY:
I can explain that.
In light of the 9
pub.'.ic comments that we received -- if we move to slide 10 10 and then I can answer your question.
11 CHAIRMAN JACKSON:
Before you go forward, I have a 12 question.
We'd like to fit in two questions.
13 MS. HANEY:
I can answer --
14 MR. MERRIFELD:
I'd like to get that question 15 answered.
I'm willing to defer to use her presentation.
16 CHAIRMAN JACKSON:
Yeah, I just -- which slide 17 were you going to?
18 MS. HANEY:
Well, I can go to-11, but'I can answer 19 it without moving ahead.
And then, I'll skip -- when I get 20 to page 11, I'll skip over it.
21 The short answer is that we received a cignificant 22 number of public comments that we had reduced it too low.
23 The 1,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> was an insufficient length of training --
24 MR. MERRIFELD:
One-hundred-and-twenty hours?
25 MS. HANEY:
One-hundred-and-twenty hours was ANN RILEY & ASSOCIATES, LTD.
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insufficient.
And a lot of the commenters said that we 2
should maybe go as high as a four-month training program.
3 And we even had commenters that said we should stay at 4
1,200; we should not have touched it at all.
And although 5
it's low. risk, what they were saying is that it's low risk 6
because individuals that are handling the material have an 4
7
-extensive amount of training.
It's not just a 40-hour. week 8
training program.
The current users receive 1,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />, 9
and that's one reason why the track record is so. good in the 4
10 diagnostic area.
And the' concern is that if the hours were 11 reduced, that might. impact on safety.
12 So, re're proposing to do up to the 700 hour0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, 13 based on public comment.
And, not just that the hours was insuf'icient, but that you can't learn radiation safety in f
14 15 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> sitting in a classroom.
You really need to be in 16.
a department, seeing how it operates everyday.
- Because, 17 during that 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />, there may not be that spill.on the 18 floor.
But, if you're in the department for four months, at 19 least one day, you're going to see a spill and you're going 20 to see how you. respond to it in a clinical environment.
So, 21 if 's really that training needs to be over a long period, as 22 C Jmpared to just sitting in & Classroom for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> or 120 23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br />.
24 MR..MERRIFELD:
Could you -- you received a number 25 of comments saying that we had overshot the mark with 120 ANN RILEY & ASSOCIATES, LTD.
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hours.
2 MS. HANEY:
Right.
3 MR. MERRIFELD:
Obviously, it must have been 4
people, who were the other direction.
Can you give us some 5
nature of the sort of gross numbers of folks?
Maybe you 6
can't, but if you can --
7 MS. HANEY:
I would say predominantly the nuclear 8
cardiology community endorsed the 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> that we proposed 9
in the proposed rule.
They were really endorsing, saying 10 that the 1,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> is not right; so, therefore, as long as 11 we were coming dr a, this was a good approach.
12 We had a large population, American College of 13 Radiology, which is a very large group'of professionals, 14 saying that we had gone too low and that we really should 15 stay status quo.
Then, there was another very large group 16 of stakeholders, the Society of Nuclear Medicine, that was 17 proposing that we should not even specify hours, that we 18 should just assess competency.
Put in the rule the 19 objectives, what you want people to learn, and'then focus in 20 on the exam and require the exam to test competency.
So, we 21 really had a wide, wide range, and it was split along 22 professional society lines.
23 Maybe I could comment on the endocrinologist for a 24 second.
In the proposed rule, we would have increased the 25 training.for an endocrinology by 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />.
The ANN RILEY & ASSOCIATES, LTD.
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endocrinologist were very concerned about the impact that 2
this would have on their profession, because of the 3
increase, and they believed that they were the right 4
individuals to be involved with treating hypothyroidism and 5
thyroid carcinoma.
We did consider their comments and we 6
would propose going into the final rule ~that there would be 7
no changes in the training and experience requirements for 8
an endocrinologist over that what is in the current' rule.
9 So, in other words, we would. maintain status quo.
10 MR. MCGAFFIGAN:
Madam Chairman?
Is there a 11 danger, especially in light of what you said on the 12 endocrinologist, and as you know, that's where I was in the 13 proposed rule, but the truth in any number that fits -- one 14 size fits all, that there may be other professionals -- the 15 cardiologists, I know, did feel that they deal, again, with 16 the relatively finite set of procedures and they might not 17 need as much training as -- they're making arguments very 18 similar to the endocrinologist.
If somebody needs a full 19 scope exposure to using literally any isotope in any medical 20 procedure, then, obviously, that person needs lots of 21 training.
And are we -- by choosing a number, are we being 22 overly prescriptive or -- that's, I guess, the question I'd 23 be interested in.
24 MR. MERRIFELD:
The way I would phrase the 25 question is:
how did you come about with the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> and, ANN RILEY & ASSOCIATES, LTD.
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you know, what kind of comfort level can we have that that's 2
the right number?
3 MS. HANEY:
Well, I can tell you how we arrived at 4
the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.
I'll answer that question first; it's 5
easier.
For the -- 700 is comprised of two components:
one 6
is 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> of classroom work, and the other 580 is in the.
7 clinical environment.
The 120 came about by looking at 8
residency programs, looking at their class syllabus, and 9
seeing what component -- how many hours were devoted.to 10.
physics, how many were devoted to radiation protection, how 11 many were devoted to chemistry.
And using -- looking at 12.
these programs, we allotted the 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />.
The 580 was 13 arrived at based upon the comments that we received from the 14 stakeholders, that they believed a four-month training 15 program war needed to be able to handle material safely.
' 16
'And I'm ii:. sing in only diagnostic use right now.
i 17 So, we were relying on the comments that we 18 received and from individuals that are in training programs 19
.that are' involved with this work day-to-day._ And that's --
20 and we're really relying on what the commenters --
'21 information that they gave us.
22 As far as the one size fits all approach, in the 23 diagnostic area,. it was very easy to focus in on radiation 24 safety, as compared to the therapeutic uses of medical 25 devices.
If you remember last year, we spoke to you, saying ANN RILEY & ASSOCIATES, LTD.
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that we maintain the status quo with the teletherapy and its 2
remote after loaders, because it was very difficult to 3
separate radiation safety knowledge from clinical 4
competency.
We believed it was a little bit easier to do on 5
the diagnostic area and whether you're using one radial 6
nuclide to image one organ or you're using multiple radial 7
nuclides for multiple organs, there is a core knowledge of 8
basic radiation safety you should have, and we believe right 9
now that that is the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, 10 MR. MCGAFFIGAN:
But, then, you have the 11 endocrinologists, who have long been grandfathered at 80, 12 and you're not -- and you're telling us you're going to --
13 it doesn't all add up perfectly.
I'm certainly not arguing 14 to go above 80.
But, you have said that for one group of 15 people, dealing with one organ, 80 is enough; but for 16 everyone else, who might also be, you know, in the category 17 of dealing with a single organ and a single radio isotope, 18 you're saying 80 -- you need 700.
There's a little bit of a 19 20 CHAIRMAN JACKSON:
Is there a need to prescribe to 21 pass the Board or is-there some methodology for providing it 22 on a professional techniques basis or something?
l 23 MS. HANEY:
I believe if we do not specify hours 24 in the rule, we would need some way of assessing the 25 individual's competency.
And the one route that was offered ANN RILEY & ASSOCIATES, LTD.
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to us was-the exam -- requiring an exam.
And whether NRC 2
.would.have that exam -- would offer the exam, it would be 3
contracted, or NRC would approve it, those were big issues.
4 They were very resource intensive for NRC, whether you took 5
route one,-two, or three.
And there was a lot of 6
controversy about the exam, about what sort of things we 7
would be looking for,.a lot of complicating fac' uns.
And 8
this is what came about from our February meeting with the 9
medical specialty boards.
10 So, just to put into the rule the objectives for d
11 the training, like you must know a, b, and c, I don't 12 believe it would give us added assurance that the 13 individuals were properly trained or properly qualified.
14 MS. DICUS:
One last question about the exam.
The 15 exam'is on radiation safety?
16 MS. HANEY:
The exam that we proposed in the j
17 proposed rule was focused on radiation safety.
But, our 18 proposal right now is not to go forward using the exam and, i
19
-instead, NRC would be involved with approving training 20 programs -- I'm sorry, not approving, recognizing training 21 programs.
22 MR-MERRIFELD:
Based on that question, what kind 23 of staff resources would be required for us to be involved 24 in approving those training programs?
25 MS. HANEY:
Involved with the training programs, ANN RILEY & ASSOCIATES, LTD.
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I'm estimating approximately 1.2 FTE involved with the 2
training programs.
Now, that assumes that we would not 3
spend an excessive-amount of time reviewing training 4
programs that were already approved by what's referred to as 5
ACGME, the Accreditation Counsel on Graduate Medical 6
Education.
-So, if -- so the 1.2 number assumes that we 7
would give some credit to a program that was already ACGME 8
approved.
And the majority of our authorized users are 9
coming to us through approved ACGME programs.
There are a 10 small number of individuals -- applicants that are coming 11 through what we called alternative pathways, meaning private 12 industry training courses.
13 MR. MERRIFELD:
Would that number -- I guess this 14 is directed towards Carl, would that require us to reprogram
-15 or do we need to add additional staff to meet those 16 requirements?
17 DR. COOL:
We are in the process right now of 18 developing the budget for next year under the' planning, 19 budgeting, and performance measures.
And, in fact, what 20 intend to propose to Carl next week will have some 21 reallocations to cover this proposal, and it will be within 22 the resources which I had available.
23 DR. PAPERIELLO:
Please -- I'm sorry, but there is 1
24 an alternative way, is what we used to do, which is deal 25 with it through licensing.
In other words, we did not have ANN RILEY & ASSOCIATES, LTD.
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anything in the regulations prior to 1986.
Between 1975 and 2
about 1986, what we did is we handled everything on a 3
case-by-case basis, which,'in my. view, would be very labor 4
intensive.
Now, granted, we put some guidance out, which 5
actually was what was written into the Part 35 in 1986.
One 6
of my concerns in this whole thing is this whole issue of 7
training was never really re-looked at in almost 20 years, 8
because what we did the last time was merely took what was 9
in a licensing guidance.
10 Now, I would point out right today, we now do, at 11 times, review training programs, to see whether they're 12 qualified.
We have done that.
So, I'm not sure exactly how 13 much we have done up to now, versus what this rule would 14 require brand new.
I don't -- it really depends on whether 15 or not entrepreneurs, people that are outside of the current 16 system would design and setup, you know, separate training 17 programs.
I'm not quite sure we've made a guess about what 18 would happen, what's likely to happen.
19 CHAIRMAN JACKSON:
I think we'd better move on.
20 MS. HANEY:
Okay.
I would move to slide 12, to 21 medical events.
One way or another, we've addressed the 22 issues that are on the two pages.
23 CHAIRMAN JACKSON:
She wants to ask a --
24 MS. HANEY:
Okay.
25 CHAIRMAN JACKSON:
-- question on slide 11.
i 1
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'l MS.'DICUS:
Slide 11; this focus the NRC of 2
approval of a training program.
With regard to the 3
' agreement states, are they~ prepared to do this?
4 MS. HANEY:
I spoke with the agreement states last 5
week at the SR-6 committee meeting, so realize that it's a 6
group of five people that were -- that I was focused in on.
7 There were some that were willing to. approve or recognize-8-
the training programs.
There were some that said they would 9
just rely on NRC.
The issue of reciprocity, obviously, came 10 up about this.
And, again, you know, there is a wide 11 variation of views.
12 CHAIRMAN JACKSON:
Will ACMUI be involved in 13 approving these programs?
14 MS. HANEY:
Yes.
What we anticipate happening is 15 that someone would come to us with an application.
NRC 16 staff would do a baseline review, looking at the instructor 17 qualifications, the environment that the training would be 18 given in.-
We would form an opinion about whether the 19 training program should be recognized or not. ' Subsequent to
~
20 that, we would take it to the ACMUI.
We would ask their 21 opinion.
Based on what their opinion was, we could go back 22 and ask additional questions of the applicant or we would 23 approve it and, at least at this point, we would notice it 24 we would anticipate noticing our recognization in the 25 Federal Register and then putting it up on the Website, so ANN RILEY & ASSOCIATES, LTD.
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there would be wide dissemination of the information that we 2
had approved the program.
3 MR. MCGAFFIGAN:
I just want to clarify this.
The 4
institutions -- I assume most graduate medical schools are 5
accredited by ACGME.
Is this a nanosecond process to say 6
that Harvard Medical or Columbia Medical or whatever is --
7 the program is up to snuff?
Or are we talking about you 8
guys actually having to churn paper on something like that?
9 MS. HANEY:
Well, what I -- again, realize, you 10 know, this is a months worth of thinking here, because this 11 is a very quickly moving process here.
What we anticipate 12 is that we would give approval to the ACGME programs.
There 13 are three ACGME programs in this area:
radiology, nuclear 14 medicine, and the therapeutic uses.
And once we gave that 15 approval, that would knock out probably about 90 ptrcent of 16 the programs.
So, for example, the program that is at 17 Harvard is already accredited under the ACGME nuclear
'18 medicine program.
So, we would not look specifically at l
19 Harvard's program, as well as the University of Maryland's.
20 So, that would take out the bulk of staff's work..And I'm-21 estimating, I believe 10-20 hours of NRC time on these sorts 22 of programs, where they already have had an extensive review' 23 by ACGME.
24 In the case where it's a non-ACGME approved 25 program -- and I should also add in those American ANN RILEY & ASSOCIATES, LTD.
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'l Osteopathic Association, AOA, that is -- does an equivalency 2
to ACGME.
In the cases where they do not have the ACGME or 3
AOA approval, that would take additional staff effort.
It 4
may even take an on-site visit, and I would estimate around 5
100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> would be devoted to review that application.
6 Also, you know, you say what number of programs would be --
7 we would be reviewing under that approach, and we're looking 8
at, say, to 10-20, a small number of programs that would not 9
fall under either the ACGME or AOA approval.
10 MR. MCGAFFIGAN:
So, 10 to 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> for all of the 11 90 percent, or is it -- you're still spending 10 to 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> 12 looking at Harvard Medical?
13 MS. HANEY:
No.
14 MR. MCGAFFIGAN:
No.
15 MS. HANEY:
It would be the 10-20 hours on --
16 MR. MCGAFFIGAN:
It' takes care of 90 percent of 17 your problem --
18
.MS. HANEY:
With the information that I have right 19
.now, that's a true statement.
We're continuing to get 20 information, as we're holding'these public meetings, as 21 we've.had the public at the ACMUI meeting, where we attended 22 it.
.So, people are constantly saying -- giving me extra 23 information.
So, if I come back to you in two months, it 24 may be different but it's because I've gotten additional 25 information.
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And the next subject area that I would like to 2
discuss with you is that of medical event on page 12.
3 Medical event -- the term " medical event" has taken the 4
place of the term -cisadministrations."
In the proposed 5
rule, we did make some changes with regards to what needs to 6
be reported to us.
As far as the threshold goes, we did not 7
make significant change, and by the threshold, I'm talking 8
about the 20 percent deviation between the prescribed dose 9
and the administered dosage.
10 We added a definition -- we added a dose threshold 11 as a means of dealing with the wrong treatment site, and we 12 added rule text to exclude cases of direct patient 13 intervention.
We did go forward keeping a requirement in 14 the-rule for notifying the referring physician and the 15 patient and responsible relative, if an event did occur.
16 The next slide gives you a --
17 MR. DIAZ:
Excuse me.
18 CHAIRMAN JACKSON:
Sure.
19 MR. DIAZ:
On your page -- slide 28, when you're 20 talking about these medical events, you know, part A, either 21 A or B, are those -- are the " ands" in A, are those " ands" 22 or " ands and or?"
23 MS. HANEY:
In 28, you would -- between A and B, 24 they're either, either condition.
Okay, within --
25 MR. DIAZ:
In A, those that differs and --
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1 MS. HANEY:
And either one of those.
2 MR. DIAZ:
So, it's or?
3 MS. HANEY:
Yes.
4 MR. DIAZ:
Okay.
5 MS. HANEY:
We received a significant number of 6
public comments in this particular area.
Many of the 7
commenters believe that the threshold should be raised.
8 They went as high as saying that we should allow a deviation 9
up to 100 percent between the prescribed dose and the 10 delivered dose.
Also, they believed that our criteria for 11 the wrong treatment site was too restrictive.
And they 12 believed that any cases involving patient intervention 13 should be deleted from the rule.
They particularly focused
'14 in on the rule language and said that it was a little bit 15 too vague.
And, again, we received the comments that the 16 rule should not require notification in the case of an 17 event.
18 On page 14, you see staff's proposed response.
We 19 are continuing to evaluate where the threshold should be.
20 That was the focus of the meeting yesterday afternoon.
So,
'21 we'll need to go back and evaluate the comments that we 22 received from the ACMUI.
Generally, we believe we'll keep i
23 it very close, if not identical, to the proposed rule.
We 24 will, however, propose a change in the issue of patient 25 intervention, and we've corrected, at least hopefully ANN RILEY & ASSOCIATES, LTD.
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corrected the rule language to make it'a little bit less 2
vague or to make it clearly understandable.
3 But, we do want to hear about patient intervention 4
cases, when the event has resulted in an unintended 5
permanent functional damage to an organ or a physiological 6
system, as it would be determined by the physician.
This is 7
picking up rule language that appears in our abnormal 8
occurrence policy.
So, in other words, the key here is that 9
a lot of the cases that we've been hearing about since the 10 rule -- the misadministration rule went into effect that 11 involved patient intervention, we would not hear about, 12 because they would not trip this threshold.
And, again, we 13 would propose that we continue to require reporting to the 14 referring physician and the patient or responsible relative.
15 MR. MERRIPELD:
Chairman?
26 CHAIRMAN JACKSON:
Yes.
17 MR. MERRIFELD:
On that slide, you first initially 18 said that the direction that you appear to be going is that 19 there would not be a change in reporting threshold from 20 where we are right now.
Now, I know -- I've had my -- I had 21 asked my staff.previously to review some of those reports, 22 and some of them do seem to be relatively, at first blush, 23 insignificant.
Are we comfortable -- are you comfortable 24 that we are, indeed, risk informed, in our determination 25 that we need not change those thresholds?
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MS. HANEY:
Yes, and it's based on information 2
that I have received in comment letters, as well as 3
reviewing the misadministration reports to date and in 4
consultation with our advisory committee.
5 MR. MERRIFELD:
Okay.
Because, some of the 6
comment letters that I know we've received have been 7
somewhat caustic on this matter, from the standpoint of 8
thinking that we really should raise this.
So, maybe you 9
could share just a flavor of some of the other letters that 10 you received that think that we ought to stay with the 11 thresholds that we have now.
12 MS. HANEY:
The commenters that we received that 13 were in support of this felt that we had an adequate 14 threshold, because it was the point where something 15 significant went wrong in the treatment, and by significant, 16 I mean whether it was procedural wise, something didn't. work 17 right in the radiation protection program.
And we had put 18 in a threshold into the rule that was a dose-based -- was a 19 isk-based threshold and by crossing that, it's at the point 20 vaere NRC should hear about it.
21 MR. MERRIFELD:
I'1 adam Chairman, if you'll bear 22 with me for a second, I have a general question.
We are 23 talking about the comments that you've received.
And I've 24 had opportunities to read some of them.
As I mentioned, 25 some of them are, you know, complementary of the things that ANN RILEY & ASSOCIATES, LTD.
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we're doing and some of them are, as I said before, quite 2
caustic, you know, people have some strong feelings about 3
'these issues.
Many of the comments seem to be various 4
groups of medical professionals, who have different 5
opinions, and so that's -- I know where those folks are 6
coming from.
7 But, what I'd like to get is some sense of the 8
nature of non-medical professional comments that we've 9
received.
Do we receive comments from the general public 10 about these matters?
You know, patients rights groups, any 11 of those individuals?
12 MS. HANEY:
No.
13 MR. MERRIFELD:
Have we sought out those groups to i
14 try to get some flavor for where they're coming from?
15 Sitting from where I'm sitting right now, it seems like 16 we're in the middle of different health professionals trying l
17 to tell us which way to go.
And I haven't heard a flavor 18 for what the patients think about all'this, the people who 19 are affected by these rules.
20 MS. HANEY:
You're correct in stating that we 21 really did not get any comment letters from the general 22 public.
I would say 99.9 percent of the comment letters 23 were either from physicians or from medical physicists or 24 from health physicist.
We did seek out the patient rights 25 advocates at the facilitated public meetings.
We invited ANN RILEY & ASSOCIATES, LTD.
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patient rights.
We invited hospital administration to come 2
sit at the table-
-We invited nursing.
3 We did have a member of a patient rights advocate 4
at all of the meetingu.
We, also, have a member on our 5
advisory committee.
And their prime focus was that NRC 6-s h o v.l d - n o t, by any way, limit medical care to patients, that 7
patients should be able to choose where they go, whose going 8
to do the treatment.
We should not have regulet 'ons' such 9
that we would keep modality from coming into general use, 10 because we over regulated it and, therefore, we killed it.
11 The other thing that was very interesting is that 12 all of the patient rights advocates indicated that they were 13 not in favor of having a requirement in the rule for 14 notifying the referring physician or the patient in the case 15 of a misadataistration or medical event.
They believed that 16 the physicians would tell them.
It was -- they were very 17 much in favor of the -- we should not interfere between the
)
18 patient and the physician's relationship..
19 It'was actually kind of surprising.
It wasn't 20 what I expected, to be honest with you.
But, again, back to 21 your statement, we did not have comments on the rule from a 22 member -- general member of the public, and we did try to 23
.get them.
24 MR. MERRIFELD:
Thank you.
25 MR. MCGAFFIGAN:
I think there's a huge silent ANN RILEY & ASSOCIATES, LTD.
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-1 majority out there, a silent group.
I'm not sure what it 2
is, but it's a huge silent group that just doesn't get heard 3
from and that's what the Commission --
4 Could I just -- on the threshold, I had a 5
conversation with one of these folks, who was somewhat 6
caustic, and they were particularly caustic about the 20 7
percent, and I didn't have it in from of me at the time, and 8
that we somehow slipped this in and this was going to affect 9
diagnostic nuclear medicine.
10 And as I read it, you have to -- the place where 11 the 20 percent comes up, a dose to the skin or an organ or 12 tissue, other than the treatment site, that exceeds by 50 13 rem to an organ or tissue and 20 percent of the dose 14 expected.
It has to be more'than 50 rem off to an organ or 15 tissue and 20 percent.
What did they have him do there?
I
'16 mean, the 50 rems doesn't matter to an organ?
- 17 MS. HANEY:
No.
I think the particular commenter 18 that you had the conversation with is focusing in more on a-19
. requirement for another section of the rule, in 3563, that 20 indicates that an individual -- a technologist or whatever 21 c(
d not administer'a dose, if it differs from 20 percent 22 of wh.at the authorized user prescribed.
And that's the 20 23
. percent that I think they're focusing more on, on that.
24 And that actually is a good thing that's in the i
25 rule, because it gives the licensee some flexibility, ANN RILEY & ASSOCIATES, LTD.
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because, as we all know, the material is decaying away.
.If 2
the patient is 15 minutes late, you're still within that 20 3
percent, so the tech can go ahead and administer it without 4
going back to the authorized user and asking him if it's 5
okay to administer it.
The easiest -- the example would be, 6
if the physician says I want 10 millicuries administered for 7
a bone sean and the tech were to administer 10.1, which is a 8
no never mind from a risk standpoint, if that particular 9
phrase was not in the rule language, theoretically, that wo'ld be a violation.
10 u
r 11 MR. MCGAFFIGAN:
Okay.
12 MS. HANEY:
So that's really the 20 percent that 13 they focused more in on.
We did get comments on the 20 14 percent that was in the section on medical event reporting, 15 and that's -- and in that case, the thought was that's too 16 restrictive than diagnostic.
But,-I believe that some of 17 the people didn't realize that you needed to trip thet 18 initial dose threshold first.
They weren't seeing.:
19 together.
And a lot of times once I had conversations with
- M)
- people and said, no, you've got to exceed this dose 21 threshold before you look at the 20 percent, then they were i
22 like, okay, Cathy, it's okay.
23 MR. MCGAFFIGAN:
Okay.
~.
l 24 MS. HANEY:
Okay.
Moving from medical event, I'd l
l 25 like to take you to another reporting requirement, and ANN RILEY & ASSOCIATES, LTD.
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that's for the unintentional exposure to the embryo fetus 2
and a. nursing child.
This requirement came about as a 3
result, again, of the abnormal occurrence criteria that 4
would require that an event such as this be reported to 5
Congress.
In the proposed rule, we included a statement 6
that a facility would need to report to us and we used a 7
dose threshold of five milliceberts or 500 milltrem.
We 8
patterned the text of the proposed rule against that of the 9
medical event text.
10 We received a significant number of comments on 11 this section of the rule and, again, you could say that we 12 were hearing from a select population of individuals.
- But, 13 they were generally opposed to the requirement and they went 14 so far as to say that either the criteria and the abnormal 15 occurrence should be raised or else the abnormal occurrence 16 policy should be revised to delete this requirement.
They 17 believed very strongly that the threshold would impact
~18 medical care, because, at this level, there are some 19 diagnostic procedures that could be in effect.
We were 20 quoted as this is a defacto pregnancy rule.
NRC, why don't 21 you just call it a pregnancy rule.
And, again, well, it's 22 not appropriate to require notification.
23 I know the ACMUI will be spending -- want to talk 24 with you about the particular thresholds and the 25 implications in the medical care -- the medical practice, so ANN RILEY & ASSOCIATES, LTD.
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1 I'm not going to try to speak for them in t. hat particular 2
area.
But, I would like to offer to the Commission two 3
proposals for a resolution in dealing with this.
The first 4
one, which is staff's preferred approach, would be rather 5
than placing this requirement in Part 35, place it in Part l
6 20.
The reason.for that is that the requirement, as it i
7 appears in the AEO policy -- I shouldn't say requirement - -
l 8
but the criteria for reporting, as it appears in AEO applies 9
to all licensees, not just medical.
Now, most of the cases, 10 if we were to hear about them, would probably come out of l
11 medical.
But, it's really more a general requirement.
12 And then if we put it into Part 20, we would be 13 allowed to maintain some consistency with all of our 14 programs, and nct just focusing on our medical.
If we did 15 do it in Part 20, we would have to do a tie between 35 and 16_
20, because Part 20 does kick out any '.nedical exposure.
So, 17 there would be a little thing we'd need to do in 35.
'18 However, the other option, should we decided to 19 proceed with it, in this particular rulemaking, staff would l
20 propose that we raise the threshold to five rem.
Now, this 21 would be putting the threshold at the point where we would 22 have to report anything that we heard to Congress.
We would 23 not be -- as the case with the medical event, we are well 24 below the AEO criteria.
In this case, I would put it right 25 there.
And, again, I would recommend that we maintain l
l l
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consistency with the medical event reporting, as far as any 2
other requirements.
3 CHAIRMAN JACKSON:
So, I mean, is the embryo child 4
considered an extension of the patient or a member of the 5
public?
6 MS. HANEY:
That's a very good question and I'm 7
not sure that we've ever explicitly answered that ques. tion.
8 There are those that would argue on both sides and I've 9
heard both arguments.
10 CHAIRMAN JACKSON:
What do you feel this comports 11 with, your staff preferred approach?
12 MS. HANEY:
With going to the five rem, I believe 13 it doesn't really go with either side, but it's looking at 14 the effects of the radiation on the embryo fetus and looking 15 at NCRP documents, ICRP documents, and feeling comfortable 16 with th'is value and, at the same time, it would allow us to 17 meet our responsibility of notifying Congress and.we would 18 not be negatively impacting medical care.
19 MR. MCGAFFIGAN:
Madam Chairman?
Is option one 20 also five rems or is it 500 millirems?
21 MS. HANEY: -Well, if you want option one, I would 22 like it to be five rem.
However, the benefit of option one, 23 it gives us additional time to investigate the implications 24 of this --
25 MR. MCGAFFIGAN:
The thing that strikes me, Madam ANN RILEY & ASSOCIATES, LTD.
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Chairman, is that we have -- I think it was a year or so 2
ago,'the National Institutes of Health put out the report
~ bout what radiation my generation got from the atomic test, 3
a 4
as we were growing up and drinking --
5 CHAIRMAN JACKSON:
Which is my generation.
~6
[ Laughter.]
l 7
MR. MCGAFFICAN:
But, how we managed to -- h.ow 8
much dose we got to our thyroids, as a result of the atomic 9
test and whether we should all be going off getting our 10 thyroids examined.
And, you know, they predicted many 11 thousands of cancers, as a. result of -- I think 12 Massachusetts, where I grew up, I probably got a couple of 13 rems, and, you know, this is New York Times.
And here, 14 we're saying five rems -- we're not even -- we're not going 15 to worry about it.
So, there isn't a reporting requirement, 16 at least, until you hit'five rems.
I don't know; I don't i
17 know.
It's -- we don't deal with -- we may well go with the 18 Chairman's question:
is this embryo a member of the public 19 or is it an extension of the mother, and society, as a 20 whole, doesn't deal with that question very well.
21 MS. HANEY:
That's really a key to what we're 22 saying.
This is a reporting requirement and not a dose 23 limit.
And that's been very difficult to argue over the 24 last year with the proposed rule being out, because people 25 are seeing it as a dose limit and I'm saying, no, this is i
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merely a reporting requirement, making no further 2
statements.
3 CHAIRMAN JACKSON:
Okay.
1 4
MS. HANEY:
Okay.
The next topic I'd like to 5
discuss is the radiation safety committee.
In the proposed 6
rule, we deleted the requirements for a radiation safety 7
committee.
The-comments that we received from the radiation 8
protection professionals, the health physicists, as well as 9
medical physicists, generally, were opposed to the deletion 10 of the requirement for the radiation safety committee.
They 11 thought it was very key to the performance of their job.
It 12 gave them a direct connection with the management of the 13
- f a'cility.
However, we received a large number of comments 14 in the diagnostic nuclear medicine area, particularly from
.15 physicians that were generally opposed to retention of the 16 requirement.
17 Looking at these two considerations and thinking 18 that we need to have our justification based on a risk 19 informed decision, the staff is proposing that we require i
20 radiation safety committee only on the higher risk
~
21.
modalities, and.also'where a facility has more than one high
-22 risk ~ modality.
So, for example, if a facility had a 23 teletherapy unit and also performed iodine 131, thyroid 24 cancer operations, then they.would have to have a radiation 25 safety committee.
The purpose being here is that once you ANN RILEY & ASSOCIATES, LTD.
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get into these higher risk modhlities,.usually, you're 2
getting outside of the nuclear medicine department or 3
outside of the therapy department.
You're involving 4
housekeeping.
You're involving the nursing staff,-
5 management, and the radiation safety committee provides a 6
mechanism for bringing these groups of individuals together.
7 While we did put it back in the rule, we did not i
8 put all the prescriptiveness back in the rule that the 9
current Part 35 has.
Right now, the rule text only reads 10 that the radiation safety committee would have 11 responsibility for program oversight.
12 CHAIRMAN JACKSON:
Why is it that the issue of j
13 involving housekeeping and the other things that come into 14 play, when you have a high risk modality, not be true, if 15 you had one such, as opposed to two?
16 MS. HANEY:
It does come into play.
And I guess 17 what we're trying to be sensitive to the commenters, to the i
18 stakeholders that are saying that if we have a small 19 program, we only have a remote after loader.
There's only a 20 small number of people that a're interfacing with us from the 21 housekeeping staff or from the nursing staff, and they have 22 appropriate mechanisms in place to deal with this.
23 But when you start getting out of tne one use, 24 into multiple use, there's a whole other group of nursing, a 25 whole other group of housekeeping people that deal with ANN RILEY & ASSOCIATES, LTD.
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S-46
~1 individuals that are getting unsealed therapies.
So, we 2
were.trying to not get a burden on the licensees.
But, yet, 3
you know, there is some truth in the fact that, you know, as 4
soon as you have one of these departmencs, you bring in 5-nursing or housekeeping, why wouldn't you?
But, again, it's 6~
just listening to the public comments.
7 CHAIRMAN JACKSON:
I mean, are you trying to make 8
an argument that having more than one modality, that somehow 9
the risk of accounts of some mishap goes up --
10 MS. RANEY:
Yes.
11 CHAIRMAN JACKSON:
-- you know, in some numerical 12 or algebraic way?
13 MS. RANEY:
Yes.
14 CHAIRMAN JACKSON:
Yes; I see.
Where's the 15 formula?
The'e's not a 16 MS. RANEY:
Where's the formula?
r 17 '
formula,that I can give you.
It's -- again, it's just 18
' listening to the comments that we've heard, being in these 19 facilities, talking with our inspectors, licenser viewers, 20 looking at'what goes wrong.
And the more people that you 21 involve in these modalities, the greater the chance of
=
'22 something going wrong.
And if something goes wrong in these 23
.particular areas, you're dealing with something that could j
24.
increase the-dose to a member of the public or to the 25 patient or to the occupationally exposed individuals.
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CHAIRMAN JACKSON:
Do we have data in some kind of 2
events database that tracks with number of modalities in the-3 high risk modalities, that shows some progression in terms 4
of numbers or severity of events, according to whether you 5
go from one to N?
6 MS. RANEY:
Not that I could tie to a radiation 7
safety committee.
i 8
MR. MCGAFFIGAN:
Madam Chairman?
l 9
CHAIRMAN JACKSON:
Please.
10 MR. MCGAFFIGAN:
The radiation protection 11 professionals, who are generally opposed to the deletion of 1
12 the requirement, how are they reacting to this cut the baby 13 in half approach?
i I
14 MS. RANEY:
They were -- in any of the meetings 15 where we have discussed this approach, they indicated that 16 they were happy with the approach, that they believe that it 17 was real spaced and that this was a much better way of going 18 than deleting the committee requirement completely.
19 Okay.
The last key issue that I'd like to bring 20 to your attention'is that of calibration of. Brachytherapy l
21 sourcec, and this would -- this is outside of the area of i
22 the devices.
These would be just the sources that would be 1
23 used outside of, like a teletherapy and a remote after 24 loader.
The proposed rule contained a requirement to 25 determine the output or activity.
We, also, allowed in che ANN RILEY & ASSOCIATES, LTD.
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rule for the licensee to be able to rely on the 2
manufacturer's calibrations, assuming the calibration was 3
done in accordance with our rule.
4 The comments that we received, there was support 5
and opposition for allowing the reliance on the 6
manufacturer's calibration and there was a limited 7
opposition to the requirement.
But, again, the majority of 8
the professional organizations, as in American Association 9
of Physicists and Medicine and the Health Physics Society, 10 were in support of the requirement.
11 Our proposed response to this is, is that we would 12 continue to require the licensees to determine the output or 13 activity.
In other words, we would not make a change to the 14 requirement in the proposed rule and that we would not 15 grandfather sources.
So, licensees would need to look at 16 their sources that they currently have and assure that they 17 have an output or an activity for the source.
18 MS. DICUS:
Madam --
19 CHAIRMAN JACKSON:
But, this is -- please.
20 MR. MERRIFELD:
When you're done, I've got a 21 question.
22
[ Laughter.]
23 MS. DICUS:
All right.
Which ones would you not 1
24 grandfather?
Fo,r example, what if a source had been -- the
]
25
. manufacturer:s calibration is done according to the rule, ANN RILEY & ASSOCIATES, LTD.
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why wouldn't you grandfather it?
2 MS. HANEY:
Well, in that case, the licensee would i
l 3
have a certificate that said -- so, those -- well, we don't 4
see that as grandfathering.
We'd see them as complying with 5
the rule.
And it's those that would not have that 6
certificate --
7 MS. DICUS:
You would not grandfather?
8 MS. HANEY:
Correct.
9 MS. DICUS:
Any of them?
10 MS. HANEY:
Correct.
1 11 CHAIRMAN JACKSON:
Commissioner?
12 MR. MERRIFELD:
I'm just trying to get some sense 13 of what we're talking about.
What's the impact of not 14 grandfathering from a cost basis?
How many -- what
~
15 percentage or amount of devices are we talking about and how 16 expensive is this additional calibration?
17 MS. HANEY:
If I can remember back a year ago, I 18 think we said that for those licensees that would have to go 19 out and do this, it would cost them around $1,000 per 20 facility, not per source, because once they got the i
21 equipment in, they could do -- use it on any number of 22 sources.
And based on data we received from the medical 23
. physics community, that there~is only a limited number of 24 individuals that would not be in compliance that would 1
25 actually have to go out and get compliance.
And in our ANN RILEY & ASSOCIATES, LTD.
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regulatory analysis, I think we used a number of around 2
$760,000, as far as the impact of this requirement.
3 We solicited comment in the proposed rule on 4
whether our estimates were correct or not.
We did not get 5
any comments that said that we were wrong.
We didn't get 6
any that said we were right, but we didn't get any that said 7
that we were wrong.
8
[ Laughter.]
9 MS. HANEY:
So, we -- and --
10 MR. MCGAFFIGAN:
Before you put up big rule.
11
[ Laughter.]
12 MS. HANEY:
And based on the input that we 13 received from the professional society, saying this was a 14 thing -- a really good thing to do and that we should do it, 15 we would proceed with it.
16 CHAIRMAN JACKSON:
Suppose you had a conanission, 17 who used a Brachytherapy source and had a treatment
~
18 modality, based on a nominal -- a treatment protocol, based 19 on some nominal source activity, what does this do?
20 Remember the Strontium 90-I source?
21 MS. HANEY:
Yes.
This is -- you have the sources 22 where the physicians are treating to effect.
And it really 23 doesn't matter to them whether the source output is 10, 100, 24 or 20u, they're still treating to effect.
This would cause 25 them to go back, get the calibration, get the output of the ANN RILEY & ASSOCIATES, LTD.
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particular source.
It more than likely would not get them 2
to change the fact that, you know, n:w that they know that 3
the half put is -- that the output is half what they thought l
4 it was, they're not going to double the treatment time.
5 They would just adjust any of their calculations and their I
6 written directive based on the new value.
I l
7 Okay.
The last thing that I would like to bring 8
to your attention are the agreement state issues, and these l
9 are the issues that the SR-6. Committee discussed with me l
10 last week, when I was in Alabama with them.
And I bring l
11 them to the attention of the Commission, just.so you are 12 aware of some of the issues that we're dealing with under --
13 trying to attempt to move toward parallel rulemaking.
l 14 NRC is proposing that we not review -- pre-review
'5 licensee procedures prior to issuing the license, especially 16 in the diagnostic area.
The agreement states, most of them l
17 will continue to review the procedures prior to issuing the l
\\
18 license.
They believe that this is very needed to provide 19 assurance that the licensee has adequate knowledge to 20 operate safely.
l
-21 There's also a difference in the goal of the 22 authorized user.
Again, most of the agreement states l
23 believe that the authorized user should be responsible for 24 patient selection, prescribing the dose, and interpreting 25 the study.
NRC believes more that the role of the i
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authorized user is in prescribing the dose and then 2
supervising the use of the material.
3 In the case of training and experience, the states 4
were generally in agreement with the approach that NRC was 5
taking.
The one exception that they had is they believe 6
that the endocrinologist should have more training than what 7
we are proposing.
In fact, they would bring the 8
endocrinologist up from their 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />, up to the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> 9
that we're proposing.
So, they would propose a significant 10 increase.
They, also, believe that it's important to have 11 training and experience requirements for the technologists, 12 since it's the techs that are actually handling the 13 material.
14
.There's a lot of discussion on the patient release 15 criteria.
This is in the requirement in 3575 and has to do 16 with at what point you can release a patient from the 17 hospital after they've been administered radioactive 18 material.
As you can remember a few years ago, we changed 19 the rule to go to a dose-based rule, previously had said you 20 could release if the body had'less than 30 millicuries.
And 21 the agreement states--- some of the agreement states liked 22 the way the rule is right now, dose-based 23 Dut, there is also a large number of stctes that 24 do not like it.
The concern has to do with radioactive 25 material getting into landfills.
If the patient -- if the ANN RILEY & ASSOCIATES, LTD.
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physician does a patient-specific calculation, allows the 2
patient to go home, whether material leaves the hospital, 3
goes to the landfill, sets off the alarm, it's the states 4
that have to respond.
So, they're concerned about that.
I 5
MR. MCGAFFIGAN:
Could I ask --
6 CHAIRMAN JACKSON:
Please.
7 MR. MCGAFFIGAN:
Doesn't the same material go to l
8 the landfill, whether the person is at the hospital or 9
they're at home?
10 MS. HANEY:
In the case if they stay at the 11 hospital, they hold the material for decay.
So it would l
l 12 become -- it would sit in the hospital until it was 13 indistinguishable from background.
14 MR. MCGAFFIGAN:
I see.
i 15 MS. HANEY:
In the case of the --
16 CHAIRMAN JACKSON:
You hold the patient until the 17 patient is indistinguishable?
18 MS. HANEY:
Yeah, basically.
19
[ Laughter.)
20 MS. HANEY:
No, until you're less than 30 21 millicuries.
22 In the case of the embryo fetus in nursing child 23 reporting, the states agreed -- or preferred that we take t
l 24 the Part 20 approach and spend a little bit more time 25 looking at it.
But, if we do not take that approach, they i
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believe the threshold should stay at the 500 millirem level.
2 There are also some concerns about the sections of.
3 the rule where we had assigned an H&S, health and safety 4
designation.
And they noted that this was really the first 5
time that we had used the NRC's new policy on adequacy and 6
capability for agreement states to look at an entire rule 7
during the development -- during the rulemaking process.
8 E
therefore, they were concerned about some of the 9
sections that had been designated H&S designations, because 10 of the implication it would have on the adequacy of their 11 program.
And we talked a little bit about the adequacy of 12 the program versus the adequacy of their regulations.
- But, 13 this was a very sensitive area to them and I just thought 14' that it should be brought to your attention.
15 MS. DICUS:
Before you leave the slide, how would 16 these issues be resolved?
Are you going to try to resolve 1
17 them?
18 MS. HANEY:
Well, some of them we are trying to 19 resolve and 'scxme of them we've agreed to differ.
Of course, 20 where we agree to' differ becomes important is on what the 21 level of adequacy and compatibility is assigned to the 22 particular requirement.
We went through -- they used a 23 process of using the suggested state reg as the basis and 24 then feeding our rule into that.
And I don't believe there 25 were any problems on any issues where they were C or above.
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So, we're okay in agreeing to disagree with them.
l 2
MR. MCGAFFIGAN:
Could I ask a follow-up really on l
3 that?
This is the plan made at the outset.
There are lots 4
of issues in this thing and you've highlighted some.
I, 5
honestly, would like to understand a little better why, for 6
instance, on the. pre-review of procedures, the agreement 7
states do it one way, we do it the other.
And I'm not sure 8
it saves the day, because we have other people, or there's 9
different rules, the authorized user, or whatever.
But, it 10 sounds like they're fairly profound differences, where you 11 guys are used to agreeing to disagree; perhaps you have for.
12 decades.
But, you know, we're sort of blessing the 13 disagreement when we approve the final rule.
And I just 14 want to make sure why I'm on your side and I'm not on their 15 side, at some point.
i 16 MS. DICUS:
And another -- the issue of 17 consistency, which we have in a lot of other areas besides 18 here.
But, you have a particular case where many of the 19 hospitals across the nation are part of health provided 20 corporations and they may have one set -- in one state, they 21 do things a certain way and, yet, that same corporation in 22.
another state, that hospital may do things differently, and 23 to what extent, at some point in time, that becomes a 24 problem.
25 CHAIRMAN JACKSON:
Okay.
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'l MS, HANEY:
All right.
And then I would just like 2
to summarize by saying that I hope I've clearly described 3
our efforts to date, since we have issued the propose.d rule, 4
and hope we have summarized the comments that we've received 5
from the stakeholders for you and given you a clear view on 6
where.the staff is on resolving some of these issues right 7
now.
And I would request any guidance from the Commission 8
on whether we're taking the appropriate response to the 9
comments and on the right path.
10 CHAIRMAN JACKSON:
Thank you.
Let me ask you this 11 question?
How long it do you think it would take you --
12 when you really come to resolution?
I guess it depends on 13 the degree of guidance you get from the Commission.
14 MS. HANEY:
It does.
And, I mean, obviously, the 15 more time, the better, but it comes a point where you have
]
16 to'say enough is enough.
We -- we're working very hard to 17-meet the due date to the Commission, with the goal.of the
.18 original date being the end of May and then with the second 19 S304 that we got that would allow us to go into June.
That 20 will -.if we had an addition'al three months, I' feel that we 211 could do a better job of recponding to the comments.
And 22 pretty much I've focused my staff's efforts on hit' ting the 23-big areas first, knowing that, you know, the more time that i
24 we get, we'll go further down.
And, obviously, because of 25-the Administrative Procedures Act, we'll have to address all i
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comments.
But, the degree to which we.will address is 2
clearly related to the amount of time that we have to do the 3
rule.
4 Once we finish the rule, we still have the 5
guidance document and the guidance document was -- did 6
receive a lot of comments.
And the key thing is that 7
stakeholders are very concerned-about us putting defacto 8
requirements in the guidance documents, and we're being very 9
careful not to do that.
We're making sure that we have a 10 direct tie to a regulation.
And then, we still have the i
11 medical policy statement that sits out there that needs to
]
12 be finalized.
J 13 CHAIRMAN JACKSON:
Okay.
14 MR. MCGAFFIGAN:
When would the guidance documents 15 be ready?
4 16 MS. HANEY:
.It depends on what my due.date is.
If 17 we had to stick with the May, June time frame, the guidance 18 document would not be ready.
I think'if we had an 19 additional three months, you know, maybe four months max, at 20 the same time that we gave you the rule, we could give you 21 the guidance document, and then that would allow you to look 22 at them together, because'of the importance of the 23 stakeholders comments on the guidance documents.
24 MR. MCGAFFIGAN:
Madam Chairman, one other 25 clarification.
This rule does require OMB review, right?
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MS. HANEY:
Yes.
2 MR. MCGAFFICAN:
Not just in OMB concurrence, 3
'really, unless we -- don't we need that guidance document 4
for the OMB concurrence process, given some of the 5
stakeholders that we know who will intervene in the OMB 6
process of I don't like where you are?
Isn't past history 7
that they ask the sort of questions that only the guidance 8
document can answer in the review process?
9 MS. HANEY:
Right.
It is, and I think the 10 preferred route is to have it available when we do go to 11 OMB.
However, we're not putting any requirements in the 12 guidance document that aren't in the rule and we've pulled 13 some things into the rule that previously had been in the 14 guidance document, like submit the form and submit the 15 procedures.
So, we have everything.
So, I would feel, if 1 16 had to, I could go to OMB and say all the record keeping 17 requirements are in the rule.
But the idea would be to have
'18 them together, 19 MR. MCGAFFICAN:
Okay.
20 CHAIRMAN JACKSON:
You know, the Commission 21' actually is considering the time line and looking to see 22 what needs to be done to allow you to have a good rule.
And' 23 so, you're going to be getting that guidance shortly.
24 MS. HANEY:
Okay, thank you.
25 CHAIRMAN JACKSON:
Any other comments?
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'l MR. MERRIFELD:
Yes.
I was going to make a 2
comment, but the Chairman beat me to it.
3 CHAIRMAN JACKSON:
I know all these -- that's all 4
right, I won't make a comment.
Thank you, very much.
Let 5
us hear from the advisory committee on the medical uses of 6
isotopes.
Good afternoon.
7
[ Pause.]
8 CHAIRMAN JACKSON:
You can proceed.
9 DR. STITT:
We've been introduced.
We have our 10 name ta 3 finally correctly placed in front of us.
l 11 CHAIRMAN JACKSON:
Thank you.
12 DR. STITT:
I'm going to adopt the process we've 13 used before.
You've seen us here in the past.
And because 14 this is an' interactive group process, rather t.h'n doing all 15 the talking, we have chopped up our comments to be made by j
-16 different members of the group.
17 This has been a long process for the Committee, 18 even longer for the staff, and probably the Commissioners.
19
. Don Cool, when we started our meeting yesterday, used a 20 roller coaster. analogy, as to'some of the ups and downs.
21 There are three of us, who are jumping off of the cart.
So, 22 we're going to be leaving it to the rest of you.
But, it l
23 has,been an interesting process; in general, very 24 educational.
And we have worked with the NRC staff to i
25 address the Commission's direction towards what we feel is a h
1 i
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rule that is risk informed and more performance-based.
2 I'll have slide number one, the ACMUI.
And they 3
feel that the occupational public and safety issues have 4
been maintained in the revisions of Part 35.
We have worked 5
with a very interactive NRC staff.
They've been responsive.
6 They've given us statements.
We've had a lot of give and 7
takes, some knock down, drag outs.
8 The function of the subcommittee has been very 9
useful, particularly when it came to the comments.
We were 10 presented on many occasions with the diagnostic and 11 therapeutic subcommittees, with detailed, detailed comments 12 from the public, and'have been asked to address these.
13 Probably one concern, or just to bring up one issue, if 14 there's any shortcoming is that there were probably many 15 other comments that we could have addressed, but time 16 constraints literally just -- I would have to cut off the 17 discussion, at some point.
Some of those comments have come 18 from the regular community, the users, and the public 19 meetings.
20 We'll move on to specific points that we wanted to 21 bring up with you.
22 MR. MCGAFFIGAN:
Madam Chairman?
23 CHAIRMAN JACKSON:
Yes.
24 MR. MCGAFFIGAN:
I think Dr. Stitt just made a 25 fairly profound. point, and Cathy Haney said earlier, you ANN RILEY & ASSOCIATES, LTD.
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know, we can deal with these secondary comments as we have 2
more time.
Some of the comments that probably regard to the 3
secondary that I witnessed at the Rockville meeting, there 4
-- you know, probably having some advice from you all would i
5 help.
So, I hope -- and under the Administrative Procedures i
6 Act, Cathy is going to deal with the recumbent.
So, if we 7
give the staff a little more time, I hope you guys use it to 8
delve down into these so called minor comments, which, as I 9
said earlier, in a bite size rulemaking, they're probably 10 major comments.
11 DR. STITT:
Well, my response to that is that I 12 think we take that part very seriously, because we know 13 where those comments came from and when reading them, we 14 recognize some of the names and faces that are in the 15 comment section.
And probably the most time consuming part 16 of many of our meetings have been some polarized views, some 17 very strong opinions.
But, if you're really trying to be 18' interactive, we have -- I think we have done a good job, as 19 a committee, and not necessarily come up with a consensus, 20 but it's been a very effective part of how we functioned.
21 View graph number three for the ACMUI, Dr.
22 Cerqueira.
23 DR. CERQUEIRA:
Thank you, very much, Dr. Stitt 24 and Commissioners.
In terms of the training and experience, 25 this, obviously, is one of the more controversial areas.
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But the Committee really made an attempt to focus on the 2
issue of radiation safety and not the practice of medicine.
3 We intentionally tried to look at what were the essential 4
features to go into radiation safety.
And --
5 MR. MERRIFELD:
I'm sorry, excuse me, do you have 6
the right slide up there?
Is that what you intended?
7 DR. CERQUEIRA:
No.
It's the previous slide, on 8
page three.
9 DR. STITT:
The label is training and experience.
10 It would be in our package --
11 DR. CERQUEIRA:
I apologize.
I didn't look up in.
12 time.
13 And as a result of that, we went through all the 14 meetings that Cathy clearly outlined.
And the efforts that L15 the committee really tried'to focus on was to try to 16 identify the specialty boards where radiation safety was 17 being tested, and use that as a means to identify competency 18 in that area.
We, also, felt to try and identify specific 19 training programs, where both the didactic classroom, 20 laboratory training would be a team.
This is essential to 21 be reviewed by.the committee and we've recommended that 22 mechanisms be established for review of the content, as well 23 as the people that would be involved in-these programs, to 24 be certain that they met the standards that were established 25 by the NRC.
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We felt that there were still a lot of people, who 2
would not be able to either take boards or receive their 3
training.
We needed to, basically, provide alternative 4
pathways for training experience that would apply to 5.
authorized users, to medical physicists, the nuclear 6-pharmacists, as.well as the radiation safety officers.
7 We've attempted to clearly outline what we felt would be 8
essential for reviewing this alternative pathway and give 9
people an opportunity to enter through that mechanism.
10 As part of this, it recognizes a fair amount of 11 people that have come into -- become authorized users 12
.through alternative pathways.
We really felt it would be 13 important to try to get a uniform national policy on i
14
. training and experience requirements.
I've had the 15 opportunity to attend the meeting of the SR-6 group and if you rea'ly look at the agreement states, there's a fair 16 l
17 amount of variability that's introduced, in terms of the 18 training requirements.
And somebody who meets all the 19 standards in one state, relocates, has to reapply, and they 20 find themselves without being able to practice, even though
-21'
'they were allowed to practice in another state.
And we felt 22 that it would have be prudent if now that this tra'ining and 23 experience is going major review and revision, that the 24 agreement states try to adopt a uniform policy, similar to 25 what the NRC.
A category C would be an appropriate level,of ANN RILEY & ASSOCIATES, LTD.
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compliance between agreement states and the NRC; that this t
2 would provide a more uniform policy and make it a lot easier 3
for people involved in training programs and especially for 4
people coming in through alternative pathways.
5 These were the major recommendations that we made.
l 6
MR. MERRIFELD:
Before we lave this slide, we
)
7 spent some time talking with Cathy about' diagnostic medicine j
8 and going from 1,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> to 120 and resulting on 700, 9
which is still a significant decrease over the original 10 requirements.
Do you agree with that number?
i 11 DR. CERQUEIRA:
Well, this is a controversial 12 subject.
Even up to two hours ago, it was discussed in one 13 of the discussions.
Since I'm perhaps a minority, I really 4
14 feel that if I'm going to comment, perhaps the other 15 committee members could comment, as well.
16 I think there are some issues related to -- well, 17 again, looking at your risk-based training, they need to
-18 make-it appropriate.
We had some que'stion in terms of 19 determining where the training was gotten. And', again, I'm a 20 nuclear medicine physician, but also a cardiologist.
And we 21 felt it was important to look at the risks, in terms of what 22 was being done, and to try to guarantee that the training 23 was obtained at a good quality program.
24
.And I think in terms of the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, we felt 25 that if you looked at, again, some of the things that Cathy ANN RILEY & ASSOCIATES, LTD.
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said about making sure that the person's environment, that 2
that' clinical experience was a part of regulation safety.
3 And in some ways, it actually improves _he quality of the 4
people that are going to be doing studies, in terms of both 5
the radiation safety aspects and someone who trains people 6
that are going to be out doing this work.
I think there's 7
some good quality clinicians, as well.
So, I think, in 8
general, the committee felt that the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> did provide 9
some assurance, but I think that there were other things in 10 this, as well.
11 CHAIRMAN JACKSON:
Well, let's hear them.
12 DR. STITT:
One of the considerations you have is 13 when you take a look at -- with various areas in training 14 requirements, you're going to have to be able to justify if 15 there's differences in hours from a risk basis, okay.
I 16 think that's an example -- for example, the endocrinology 17 people come in with a therapy procedure, basically, on cell 18 byproduct material and with 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of. training.
Well, how 19 do you justify that vis-a-vis a group of people that are 20 using unsealed byproduct materials, which include iodine 21 131, where we're saying 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of procedure.
So, you 22 know, that's something you can't -- you can't just look at 23 i it solely from the perspective of the regulating rules and 24 what their standard training is, but it also has to make 25 cense from a justification standpoint.
So when you're ANN RILEY & ASSOCIATES, LTD.
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'l taking a look at these,-you need to keep that in your mind.
2 Well, I'm just going to take the back road, only 3
in the sense that my experience in those we've represented 4
would be in the therapy at the high dose levels.
And when 5
you look where the controversies are and where the concerns 6
are, the status quo is basically being maintained at the 7
four and six.
And so, we're sitting around a little more 8
passively in these parts of the discussions.
I think this 9
tends to be more the diagnostic and some of the therapeutic 10 unsealed sources.
11 MR. WAGNER:
Well, I think that on face value, 12 there's always going to be questions raised.
But, I think 13 what we have to consider and understand is that we'll never 14 have complete agreement on these issues.
The 15 recommendations that have come down are really a very 16 measured decision, based upon looking at each of the 17 individual practices, trying to look at the risks and 18 benefits,.and trying to make a very level assessment.
If 19
.you just look at them on faco value, sometimes you'll say, 20 oh, that doesn't make any sense.
But, if you look really 21 deep and behind the arguments and the issues that 22 individuals have placed in the committee and elsewhere, 23 you'll see that there are subtleties in there that really 24 enter into the question.
And how you go one way or the 25 other, based upon those individual subtleties, is always a ANN RILEY & ASSOCIATES, LTD.
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difficult issue.
)
2-For example, if you only do high dose therapy by
]
1 3'
the one modality, etc., how does that differ from a person,
)
4 who uses diagnostic levels all the time?
Well, the facts 5
are the person, who is doing diagnostic levels all the time, 6-that person is treating people, who you don't want to have 7
high doses.
So, you want to make sure that they have really 8
good training across the board in multi-modalities; whereas 9
one' person is giving high doses all the time, is giving them i
10 to sich people, it's very, very well delivered, and it's a 1
1 11 very systematic -- and I'm thinking of the treatment of the i
12 thyroid, for instance -- very systematic and it's vcry 13 direct and it doesn't involve a lot of variation.
So, q
14 there, you've got another issue.
So, in all these issues, 15 there's more to it than just the matter of say, oh, this 16 doesn't make any sense on. face value.
17 CHAIRMAN JACKSON:
Thank you.
18 MS. MCBURNEY:
I came into this advisory committee i
19 with some basic concerns, especially about the use of 20 radionuclide, and my neing an endocrinologist'didn't help.
21 That. differed from other unsealed uses for therapy.
- But, 22 some'of the other members of the committee, as we expressed, 23 you know, studied it -- you know, this is the reason for 24 that. discrepancy.
I do-agree that going to the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> 25
' total for diagnostic is appropriate, because, as Cathy ANN RILEY & ASSOCIATES, LTD.
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mentioned, you do need some time in that clinical setting, 2
in order to see all the different types of things that you 3
'would need to address, as a diagnostic authorized user.
4 CHAIRMAN JACKSON:
Thank you.
5 DR. CERQUEIRA:
I'd like to make one last comment.
6 Some of the questions that the cardiology community has 7
relates to where this training is gotten, in terms of the 8
clinical experience.
We pretty much support the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of 9
adapted classroom and 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of supervised experience.
10 But, we're talking about 580 hours0.00671 days <br />0.161 hours <br />9.589947e-4 weeks <br />2.2069e-4 months <br /> of clinical exposure to 11 procedures.
And as the rule is written, in terms of the 12 ACGME requirements, the cardiology programs currently don't 13 necessarily stipulate all of the hourly requirements, 14 neither do the endocrinology boards or the ACGME, the 15 endocrinologist.
And this would somehow model some people, 16 who are authorized users, but training people within the 17 cardiology program to some preceptor statement for the 1L8 people.
Well, that would introduce a certain amount of 19 difficulty.
And it's true that these programs could be 20 reviewed by the NRC and the ACMUI, but that would add quite 21 a bit of work to the process.
22 MR. MCGAFFIGAN:
Madam Chairman?
I'm just 23 wondering, classroom counting a number of hours, that's 24-straightforward, probably counting the 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> is 25 straightforward.
What do we mean when we say you have to ANN RILEY & ASSOCIATES, LTD.
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have 580 hours0.00671 days <br />0.161 hours <br />9.589947e-4 weeks <br />2.2069e-4 months <br /> of clinical experience?
Does that mean if 2
I'm a cardiologist -- a future cardiologist, that I sort of 3
'have to be in the hospital setting, where somebody might be 4
using radionuclide down the hall during those four months, 5
and if there's a spill there, somebody will pull me in and 6
say, see, this is a spill and this is how we handle it, or and so, you'll just -- I mean, you'll just count four 7
8 months worth of -- you cook up the 580 hours0.00671 days <br />0.161 hours <br />9.589947e-4 weeks <br />2.2069e-4 months <br />?
Or is it 9
real, you know, for 580 hours0.00671 days <br />0.161 hours <br />9.589947e-4 weeks <br />2.2069e-4 months <br /> of your cardiology -- I'm not 10 sure, your internship, whatever it is, four months you'll 11 focus entirely on the use of radionuclides in treatment of 12 heart disease?
13 DR. CERQUEIRA:
As the current guidelines for 14 cardiology training, they recommend that people that do this 15
-- they have four to six months.
And that 580 hours0.00671 days <br />0.161 hours <br />9.589947e-4 weeks <br />2.2069e-4 months <br /> should 16 consist of performing the stress portion of the studies, 17 interpreting the studies, being there when the patient gets 18 subjected with a radioisotope, being involved in some of the 19 quality control with the department.
But, I think the 20 committee, in general, felt that it was important to have 21 people in the clinical environment to see the problems that 22 can occur:
the spill that occurs on the treadmill, the --
23 and some of the other issues that arise.
We felt strongly 24 that to allow people to do as you say, which is basically 25 just to be at a facility, to be in a classroom someplace, ANN RILEY & ASSOCIATES, LTD.
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would not meet the broad exposure, the time element, which 2
is essential to see a variety of cases and a variety of
~
3 problems that may arise.
4 MR. MCGAFFIGAN:
If we pass this rule, people will 5
be able to count those hours honestly and there won't be 6
disputes as to whether the hour was devoted to this or 7
whether the hour was devoted to watching open heart surgery 8
down the hall or whatever?
9 DR. CERQUEIRA:
Well, I think we can establish the 10 rule -- and sort of the professional medical societies are 11 encouraging this, and I think people will be conpliant.
12 But, obviously, there will be, you know, breaks in trust.
13 But, in general, I don't -- I don't see it as going to be as 14 much of an issue.
15 CHAIRMAN JACKSON:
Dr. Stitt.
16 DR. STITT:
One comment that addresses that.
We 17 felt there's an important role of the preceptor, who will be 18 signing off on this particular training.
The precepter is 19 commonly the residency program director, who has a broad 20 view of what that individual trainee has been involved in 21 and is going to be less likely that, you know, an hour here 22 or an hour there can be doctored; whereas, you're going to 23 be looking at a broadened program.
24 CHAIRMAN JACKSON:
Dr. Wagner?
25 DR. WAGNER:
- Yeah, I think also the other fall ANN RILEY & ASSOCIATES, LTD.
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back is the fact that these programs have to be approved --
2 the training programs have to be approved by the NRC.
And 3
if they're, say, an ACGME approved program, they're 4
specifics from that agency to specify what an individual 5
must do in the training program.
The whole idea here is to 6
keep it out of the rule -- keep the prescriptiveness out of 7
the rule space, depend clearly on the professionalism _of the 8
training programs to decide what that is.
And you have some 9
control through your assessment of the programs, the 10 approval of the programs.
There's a preceptorship that has i
11 to be approved.
So, there is guidelines here to make sure 12 that that is maintained at the proper level.
1 13 CHA2RMAN JACKSON:
Okay.
Can we go on?
14 DR. STITT:
Okay.
We're on view graph four, j
l 15 medical event.
The ACMUI agrees that the -- those 16 thresholds currently capture events of concern and that 17 proposed dose thresholds will provide regulatory relief from 18 some of the lower risk events that ha've been numerous, and 19 kind of confounding those of us who do consultations, and
~
20 one of the probably strongest examples of that is wrong 21 treatment site.
22 A large segment of consultation time concerns this 23 third point, that is patient intervention.
And we feel that 24 events occurring as a result of patient intervention should 25 not be reported to the NRC.
There's one big caveat, and we 4
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don't have all the language in front of us, but that, I 2
think, was put in front of you by one of Cathy Haney's view 3
graphs, such that a dose that would provide permanent injury 4
to an organ or tissue wouldn't be captured.
So, one of the 5
examples, in spite of the best that you can do, an 6
individual that's got a source treating the bronchus for 7
lung cancer, they're bed rest, they have drugs written to 8
suppress cough, but the patient can cough and the catheters 9
can change position.
That's a relatively common example.
10 We wanted to, in case you had any question, 11 reaffirm that we don't support regulation that requires 12 notification of the referring physician or patient, es we 13 feel that this continues to be redundant in the existing 14 standards of care.
15 MR. MERRIFELD:
I'd like to -- speaking about 16 redundant, you, also, have that same statement on the bottom 17 of the next slide.
18 DR. STITT:
Right.
19 MR. MERRIFELD:
3xplain to me the redundancy?
And 20 I know -- I think at the end of your statement, I'd like to 21 hear and see whether our staff agrees with you or not.
22 DR. STITT:
Patient care is what I do all day, 23 every day, unless I'm in Washington.
And if there is some 24 modification of a treatment plan, whether -- no matter what 25 created that, the patient and I discuss what's going on.
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So, the redundancy relates to federal regulation; that is 2
taking care of patients in the standards that I hold myr, elf 3
to and ethical standards require that I discuss this matter 4
with the patient.
5 We have had two members of the public, who 6
actually have been committee members of ACMUI, who very 7
expressly stated that they found the reporting requirement 8
frightening to-them, as individuals; that they feel it's 9
disruptive to their communication with the physician,,who is l
10 managing them, and realize that the members of public, who 11 are usually working with us, have been through some intense i
12 medical system.
So, they are speaking from their firsthand l
13 knowledge, and they find that the requirement for reporting, l
14 the federal requirement, is interfering with their 15 relationship with their physician.
So, that's our personal 16 experience, as a committee with members of the public.
j 17 MR. MERRIFELD:
Starting with the Chairman,- I'd l
18 like to get the staff's view of why we are where we are.
19 Cathy or Carl?
20 MR. DIAZ:
Excuse me, when you say " federal 21 requirement," you mean NRC requirement?
22 DR. STITT:
That's right, through Part 35 rules.
l 23 MR. DIAZ:
Through Part 35.
24 MS HANEY:
This has been an issue that the staff 25 has looked at for several years.
It really came about first i
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'1 with the medical -- the misadministration reporting in the 2
early '80s, and it has elicited a lot of conversation among 3
staff.
By going back and referencing some of the old 4
documents, the Federal Register notices, we are where we are 5
today because of Commission decisions that have said that if 6
-- I guess, basically, we don't want to be in a position 7
where the NRC has information that the patient does not 8
have.
And without this requirement, we can't be assured 9
that the patient would not have that information.
10 We, also, believe that by assuring that this 11 information gets to the patient, that we are putting in 12 position where the physician and the patient together can 13 make an informed decision about their care.
And these are 14 items that have been issued in Federal Register notices and 15 for why -- you know, basically, stating where we are today.
16 But, it hac caused a lot of discussion.
17 MR. MERRIFELD:
Yeah.
Did we -- just to reiterate 18 my question, did'we receive any comments from the public, 19 -
outside of the medical community, asking us to r2 peal, you 20 know, our regulations, as it relates to this particular 21 element?
22 MS. HANEY:
No.
Other than the patients rights 23 advocate that Dr. Stitt said that we have on the committee 24 and the ones that attended the facilitated public meetings 25 and, as she said, they indicated that the requirement was ANN RILEY & ASSOCIATES, LTD.
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not needed.
Now, if you go back to the ACMUI of probably 2
about.two years ago, we did have a patient rights advocate 3
that felt very strongly that this should be in the rule.
I 4
MS. MERRIFELD:
This should be in the rule?
5 MS. HANEY:
That it should be in the rule.
But 6
other than, you know, th',se particular points, we did not 7
receive any comments on it.
8 CHAIRMAN JACKSON:
Okay; thank you.
9 MR. DIAZ:
Excuse me.
Dr. Stitt, the redundancy 10 comes from the fact that you feel that there is an intrinsic 11 obligation for the administering physician to discuss with I
12 the patient any mutual misadministration that is beyond what 13 you would call, you know, variations that exist in clinical 14 settings?
15 DR. STITT:
Right, that is talking to a patient 16.
about some event that happened.
Another example, because 1
17 that's probably easiest for me to talk in a fashion of 18 patient care:
a patient has been treated for cervical 19 carcinoma and the source strength might have been used 20 incorrectly.
You'have to talk to the patient to say the 21 dose that we wanted to give you didn't achieve; we didn't 22 use the right source; amongst five, we had one that wasn't 23 the correct strength.
So when we do your second insertion
]
24 of the plan that we had for two insertions, we're going to 25 make some adjustments.
And part of the discussion would be ANN RILEY & ASSOCIATES, LTD.
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this means LLat we're able to give the dose that we wanted 2
to give.
Se, it would most commonly come up in the course 3
of discussing the patient's care.
4 MR. DIAZ:
For example, in -- and I hate to bring 5
those up, but, you know, we reported last. year abnormal 6
events on some major misadministrations, you know, to the 7
Congress of the United States.
And they're, obviously --
8 you know, they're all related practically to the thyroid, 9
but not coming from endocrinologist office.
And how would 10 you deal with those, you know, real, large single issues 11 that still are out there?
How would you deal-with it?
12 DR. STITT:
Well, I don't deal with any thyroid --
13 MR. DIAZ:
I know.
14 DR. STITT:
Dennis, you want to take a --
15 MR. SWANSON:
Well, I think what we're talking 16 about, those are still being reported to the NRC.
The 17 concern deals with the patient notification aspects of this.
18 And you're making the assumption that that physician is not 19 notifying that patient.
20 MR. DIAZ:
No, I didn't make that assumption.
In 21 fact, I wanted to be reassured of how you would actually 22 deal with the' situation.
i 23' DR. CERQUEIRA:
And I think you said yourself, 24 that instead of the reporting the misadministrations, the 25 reality, in terms of for diagnostic uses, that does tend to ANN RILEY & ASSOCIATES, LTD.
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l 1
create a certain amount of distress in the mind of the l
l 2
patient, because he doesn't -- he or she doesn't fully 3
understand the risk that's involved, which is relatively' l
4 low.
And if you look at all other areas of medicine, when I 5-do cardiac catheterization, I can potentially do lot more 6
harm by making mistakes, but I don't have to report it to'a 7
federal agency.
It's basically controlled by committees and 8
hospital rules, other areas within the hospital, the 9
professional medical societies that control this.
If I give 10 the patient the wrong dose of an antibiotic, I don't have to 11 report to anybody, again, because the risk is relatively 12 low.
And according to the committee, I can give a 13 tremendous dose, which could have lethal. effects, and 14 there's no reporting requirements.
15 MR. MCGAFFIGAN:
Even to the patient?
You need l
16 not tell the patient I just gave you a high dose or l
17 something?
18 DR. CERQUEIRA:
No.
Again, but that's -- it's 19 regulated at the 1 cal level and I don't have to report it 20 to an agency.
.So, yeah, I think it's important to be able i
21 to do it within the hospital structure, the procedures in l
22 place currently that deal with these kind of issues.
And l
23 I'd have to notify the patient.
l 24 We're saying here, notify the NRC.
The risks are 25 relatively low to these patients.
In terms of the ANN RILEY & ASSOCIATES, LTD.
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doctor-patient relationship, it does create a distrust,
.2 which doesn't need to be there.
3 MR. MCGAFFIGAN:
Could.I ask --
4 CHAIRMAN JACKSON:
Yes.
5 MR. MCGAFFIGAN:
The patient notification is 6
actually the referring physician notification.
The 7
referring physician decides whether to tell the fretient,-I 8
guess, it's generally done.
As you say, the practice of 9
medicine woult usually do.
So why is it, if it's going to 10 be done anyways, why can't -- and I think we made an 11
. adjustment in the rule, so that we don't have to -- whatever 12 bureaucratic report you send in to us doesn't have to be the 13 mechanism you use to. talk to the patient, notify the 14 patient.
If you're going to do it anyways, what -- I guess 15 you're saying why have a rule.
But if we give the public 16 some comfort, that if they're dealing with radioactive 17 materials, if a mistake is made, they're going to.know about
-18 it, at least there's a rule that they're suppose to know 19 about it, in addition to whatever the practice'in the 20 community is.
What's the matter with that?
21 DR. STITT:
I think one of the issue t
22 disagreement. about requiring notification and you use the --
23 it's your feeling that it would be comforting to the patient 24 to have a copy of this letter.
And we --
25.
MR. MCGAFFIGAN:
Not the -- I think we even waived ANN RILEY & ASSOCIATES, LTD.
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'79 l-1 the copy of the letter,-at least we talked about it.
2 DR. STITT:
But, you can write it in your own L
3 words.
But, there's a difference as to whether that's 4
comforting or not comforting, depending on who you're 5
talking to.
6 MR. MERRIFELD:
I want to make a comment.
I come 7
from -- I'm a new commissioner.
I came from the Senate l
8 Environmental Committee and one of the issues that we had 9
with the Jurisdiction Subcommittee that I was staff director.
10 for was the Community Right To Know Act, which requires 11 corporations that emit toxic substances to notify the i
12 community surrounding them -- notification of materials that 13 were released to the public.
There are similar reporting 14 requirements under the Safe Drinking Water.Act, and other 15 federal laws that require notification of these materials.
16 The analogous situation is there were some efforts 17 by someone in Congress some years ago of rolling that back,
'18-take away some of the reporting requirements.
And the human l
19 cry, when the average member of the public found out, was 20 exceedingly high.
And while I recognize and appreciate the 21 concern that you're raising about the fact that you already 22 have a doctor-patient relationship, you already feel you 23 have an obligation to provide this information to your 24 patients, the problem is we have a requirement on the books And fer_us to repeal that and take away notification 25-now.
l l
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for your patients that they currently have, in effect, 2
somehow is denying them information that is currently 3
available, is something, I think, although we haven't 4
received a lot of comments on it yet, is something, at 5
least, we certainly potentially could.
6
- Now, I. don't know whether the staff has explored 7
with you all perhaps another option of doing this.
It seems 8
to me one of the other ways one might explore this is if you 9
had a certification, the doctor could say I certify that I 10 have provided this information to my patient. You say you 11 informed your patient of this.
If you're willing to certify 12 to that and send us a letter with your certification, 13 signing on the dotted line, that may be -- there may be no 14 need for us to inform the patient, if you're willing to 15 certify that you've already done it.
I raise that as a 16 suggestion.
I don't know what your reaction is to that.
17 MR. SWANSON:
In fact, if you look at the rule as 18 proposed,.one of the requirements is that as part of the 19 reporting this to the NRC, as part of that reporting 20 requirement, the physician must tell the NRC if they hsve 21 reported this to the patient; and if not, why not, which 22 would seem to address your issue.
What becomes particularly 23 disconcerting is the requirement that you have to provide 24 any other written information back to the patient, as part 25 of the patient notification.
So, what happens is you have a ANN RILEY & ASSOCIATES, LTD.
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relatively minor event from a risk standpoint, you've 2
expl..ned it to the patient, the other things outside of it, 3
_you're going down your merry way in your care, and then all 4
of a sudden they get this piece of paper,.okay, that 5
describes it on paper.
And then it takes a new level of 6
significance for them.
7 MR. MCGAFFIGAN:
Honestly, I thought we had tried j
8 to deal with this issue of different types of notification.
9 And Cathy could remind us, I thought we-had tried to deal 10 with it in the proposed rule and allow for there to be one 11
. method of communication with the patient and another method 12 potentially far more bureaucratic with us, and I'm trying to 13 search for that in the rule language.
14-MS. HANEY:
That's correct, it's in there.
I 15 don't have the rule with me.
It should be near the end of 16
-- it should be 35.3 or 4 or 5 (a) (1).
17 MR. MCGAFFIGAN:
It says, assuming either a copy 18 19 MS. HANEY:
Right.
20 MR. MCGAFFIGAN:
-- of the report that was 21 submitted to the NRC or a brief description of both the 22 event and consequences as they effect the individual.
I'd
'23 assume -- when we put that flexibility in, I assumed most of 24 you guys were going to opt for the brief description of both 25 the event and consequences, as they may affect the ANN RILEY & ASSOCIATES, LTD.
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individual, in your own words and not give them -- if the 2
reporting requirement fills everything from A through D, 3
it's probably a pretty bureaucratic report that you send in 4
to the rest of us.
And I can see -- so, we were sensitive 5
to this notion of trying to allow you to communicate with 6
the patient in plain language and possibly putting the risks 7
into context and have that separate from the report that you 8
send to us for all these other things.
9 CHAIRMAN JACKSON:
I think we've about exhausted 10 this question.
I think we need to move on.
11 DR. STITT:
We have slide number five.
Lou 12 Wagner.
13 DR. WAGNER:
This deals with the unintentional 14 exposure to the embryo fetus and the nursing child.
The 15 ACMUI endorses the proposal to address the reporting in Part 16 20 rulemaking.
But, in our discussions, it was quite clear 17 that if that happens, the ACMUI feels that special 18 consideration must be given to the pregnant patient.
19 I'd like to address why we feel that that's the 20 case.
In Part 20', you're dealing mostly with protection of 21 the public-trying to prevent unnecessary exposures to the 22 public.
But, in medicine, we intentionally expose people to 23 radiation.
That 's our j ob.
That's what we do.
And we may 24 end up intentionally exposing a conceptus that we didn't 25 know existed, okay.
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We cannot, in medicine, ever separate a fetus'or 2
embryo of a woman from the woman we're treating, herself, i
3 And in medicine, we.always have been involved with this risk 4
informed type of procedure, in this situation.
We always 5
have to take into account what are the consequences of our action, not only on the health of the mother, but on that of 6 e 7
the baby.
We do it in our practice.
So, it's an entirely a
different situation in just treating that embryo fetus as a 9
member of the public.
It's not that separate.
It's not 10 that clear.
So, we strongly feel that if this is moved into 11 Part 20, that some special consideration must be given to 12 the pregnant patient.
13 We endorse the 50 milliceberts per five rem, as an 14 an. ropriate reporting level, because that would have minimum 15 impact on the patient-physician relationship and will have 16 minimal impact on the current standard of care and the cost.
17 We feel that the current proposal level of 500 millirem --
18 or that a proposal of 500 ndllirem gets into 'a lot more 19 difficulty with regard to intrusion into the 20 patient-physician relationship, and there's a lot more 21 subtle issues that are involved with women who are pregnant, 22 but can't be detected as pregnant.
And those issues, which 23 we've already addressed in the medical community and in 24 medical care, but cannot be addressed within this kind of 25 rule space.
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We feel that the statements of consideration do 2
emphasize this is a reporting level and not a dose limit.
3-One of the biggest problems we run into across the field,'
4-and it's outside of your recognition, because you don't 5
experience this, but we experience it a lot, and that is 6
when we -- when people look at levels, they look at these 7
-levels of -- for occupational levels or other levels.
And 8
in.the medical community,.they translate them as to being 9
the threshold for these levels.
Or the area -- well, gee, i
10 it's really dangerous if we get above this level, whatever.
11 Well,.in medicine, we don't look at it that way.
'ruc have j
12 to look at the benefit risk issues.
And so, in the 13 statements of consideration, we need to emphasize that this 14 is a reporting level and not a dose limit.
~
15' ACMUI does not support any regulation that 16 requires notification.
Again, we'?s discussed that.
I 17 guess we don't wish to venture into chat issue again.
18 CHAIRMAN JACKSON:
Okay.
19 MR. MERRIFELD:
I have a question about.this.
20 It's just not clear to me, and it wasn't when we had our
.21 staff discussion, what is -- I understand the difficulty of 22 determining whether a patient is pregnant or not, in-cases 23 where you don't know.
But what is the right level to be I
24 concerned about where there is some knowledge that the 25 patient is pregnant?
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DR. WAGNER:
You're asking for a threshold and in 2
medicine, I can't give you that threshold, because 3
'everything we do is a benefit risk relationship.
In some 4
cases, it's higher; in some cases, it's lower.
You can't 5
define a threshold in medical care and saying that's it.
6 You have to look at it, in terms of perspective.
7 These people are sick people.
They are people, 8
who need medical care.
And the judgments and the rules of 9
certain medical practice already establish protocols,.by 10 which we would manage the protection of these patients.
11 Some of the diagnostic examinations that are given would be 12 given on occasion to an individual, who cannot be detected 13 at being pregnant and the dose would exceed the 500 millirem 14 level.
That would affect that kind of procedure and this 15 kind of reporting, because it now puts a regulatory it. pact 16 cn that kind of procedure.
And that tends to interfere with 17 the patient care.
i 18
'There could be individuals, in order to avoid the 19
' reporting, who would instead opt out for an examination 20 that's not regulated.
They could even deliver a higher 21 dose.
So, there's many facets where this can impact what 22 we're doing when we set that level that low.
So, we -- when 23 you analyze this whole data, we did it for the risk benefit.
24 We tried to look at the levels that would be considered to 25 be definitely things that we want to know and we selected ANN RILEY & A.CSOCIATES, LTD.
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the five rem level as being that based upon the risks and 2
looking at the benefit risk, in terms of managing the 3
patient, as a patient.
4 MR. MERRIFELD:
Just my edification, to what 5
extent -- you said the benefit -- to what extent does the 6
determination regarding the fetus figure into it?
7 DR. WAGNER:
Well, in diagnostic examinaticas, 8
there are rules laid down as to what you do to try t'o screen 9
out patients, who might be pregnant, for instance, okay.
10 And so, you implement those rules, as your first line.
- Now, 11 if the doses are going to be higher, in some cases, such as 12 the iodine 131, whatever, in those situations, it actually 13 is required that a pregnancy test be performed, okay.
So, 14 there is a discrimination that goes on.
15 What I'm tryin; to point out is that there are 16 diagnostic examinations, which we presently do today, 17 wherein the fetus would receive more than the 500 millirem.
18 She might be in an early stage of pregnancy, but it's still 19 with the standards of medical practice to go ahead with the 20 study, in light of the fact you don't know about the i
1 21 pregnancy, okay.
So, that's the reason this 500 millirem 22 level really gets to be a controversial and tough level for 23 us.
24 MR. MCGAFFIGAN:
Could I follow up?
Are you 25 saying that what the 500 millirem level would do is drive ANN RILEY & ASSOCIATES, LTD.
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you in more procedures to do what you do in iodine 131, and 2
basically by our reporting requirement, we would change the 3
practice and a pregnancy test would probably br: required 4
among modalities?
5 DR. WAGNER:
Yes, that could happen.
And not only 6
that, it might have another adverse effect, which might be 7
that in some cases, in order to avoid the potential for the 8
reporting, those particular studies, instead of being done 9
in nucl' ear medicine, might be referred to an x-ray study, 10 where the reporting isn't required, in order to atoid j
think not happen.
11 reporting, which we would like to not 12 But, it could require some physicians to order a different 13 kind of examination, that might even deliver a higher dose, 14 such as a CT examination or something of that nature.
15 MR. MCGAFFIGAN:
CT exams typically would --
4 16 people get rems?
17 DR. WAGNER:
Two rem.
18
.MR. MCGAFFIGAN:
Two rems?
19 DR. WAGNER:
Two or four rem.
20 MR. MCGAFFIGAN:
What does the fetus get, if --
21 DR. WAGNER:
If it's an examination of the pelvis, 22 two to four rem.
23 MR. MCGAFFIGAN:
One of the problems that we have, 24 as i said earlier, is the public is adverse, particularly 25 when it comes to children, to apparently something in the ANN RILEY & ASSOCIATES, LTD.
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order of two rems to the thyroid, as a result of nuclear 2
testing or -- and the National Cancer Institute says there 3
will be 10- or 20,000 extra doses of thyroid cancers, as'a 4
result-of the nuclear testing program, in getting into our 5
milk and all that.
So, you know, we deal with these -- you 6
know, how do we --
7 DR. WAGNER:
Well, I think the issue is, again, 8
you have to look at this issue, in terms of whether or not
]
9 you're talking about members of the public, where you're
'. 0 basing risks on something that -- you know, everybody knows 11 that risks exist.
12 MR. MCGAFFICAN:
Right.
13 DR. WAGNER:
All those risk estimates that are 14 made for those low doses are made upon extrapolated numbers, 15 not on numbers that-are really known or well defined, okay.
16 Now, you're going to start applying those to patients and to 17 fetuses.
This is a different story.
You can't do that.
18 We're dealing with sick people.
We're dealing with people 19 that need medical care and we.are going to intentionally 20 expose these people to this radiation.
That 's our j ob, i
21 okay.
22 MR. MCGAFFICAN:
Right.
23 DR. WAGNER:
So, you can't separate the fetus from 24 that.
And medicine has recognized that for quite some time 25 and has drawn up its rules and its guidelines, that are ANN RILEY & ASSOCIATES, LTD.
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based upon a risk informed decision, in terms of medical' 2
care for patients, separating out diagnostic examinations 3
from other particular type of examinations that may deliver 4
higher and higher doses.
5 MR. MCGAFFICAN:
Can we just I'm sorry -- would 6
you -- if one of these modalities, say, would result in 7
three rems to the fetus, that you don't currently require a 8
medical -- a pregnancy test before you administer, and after 9
the fact, if I note that the fetus did get three rems, what 10 is standard medical practice, with regard to watching that 11 child after it's born and see whether any damage was done to 12 whatever organ it was --
13 DR. WAGNER:
Well, I have done, personally --
14 standard medical practice does not systematically follow all 15 these patients, and it depends upon the situation.
For 16 example, if the patient was exposed prior to two weeks past 17 conception, thrat falls within the realm of medical guidance.
18 Many organizations, RCRP, for instance, the guidance is i
19 quite clear that the risks in this range, if anything 20 happened, assuming the risk compared to the benefit, that 21 there is no need to pursue any follow up or anything of that l
22 nature.
I have personally followed them up, to find out l
23 what the heck happens.
And I've looked at these records l
24 later on and done studies myself.
But, it's not a matter of 25 medical -- of standard medical practice.
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Now, if the exposure occurred later and you didn't 2
-- you did all your screening and everything is right, but 3
it turns out, unfortunately, the patient was pregnant and at 4'
a later stage and whatever, then we have to assess the 5
situation for the patient, look at the risks, benefits, and 6
counsel the patient appropriately, with regard to what may 7
have occurred, okay.
That patient slips through our 8
screening processes, etc., okay.
So, that's the way we 9
handle it medically, and it's a matter of a one-to-one basis 10 with the patient, at the time.
11 Quite frequently, we'll get calls from an 12 obstetrician, who will say, look, last month, it turned out 13 that she was pregnant, at that time.
I'll go back and look 14 at the records and find out that based upon all the records, 15 she could have not been more.than one week past conception, 16 at that time.
That falls within the standard of practice.
17 I informed the obstetrician, at that time, this is what 18 occurred.
There's no conceivable risks that anyone knows 19 about this dose level, at this time.
No action is 20 recommended.
21 CHAIRMAN JACKSON:
Okay.
I think we've exhausted 22 this one.
23
[
DR. STITT:
All right.
Let's~go on to Rnth 24 McBurney, who is going to discuss our view graph number six, 25 radiation safety committee.
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MS. MCBURNEY:
Thank you.
On this issue, the 2
ACMUI does endorse the staff recommendations on the draft 3
final rule, to require the radiation safety committee for 4
licensees that have multiple types of uses under the high 5
risk categories, those being unsealed radioactive material 6
that require a medical directive, annual Brachytherapy, and 7;
then Subpart H, which is the teletherapy, remote after 8
loaders, and gamma stereotactic units.
9 We, also, added a comment that if there were 10 multiple units used under Subpart H, for example, if you had 11_
a teletherapy unit:and remote after loading and 12 Brachytherapy, that that also would kick in the need for a 13 radiation. safety committee.
We feel that this 14 recommendation, after seeing all the comments, is consistent 15 with the risk-based approach that the Commission is taking 16 toward these.
These are the types of facilities that would 17 be.more likely to-involve multiple areas of the licensed 18 facilities, such as the nursing and housekeeping and so 19 forth.
12 0 But, in setting up the -- also setting up the 21 radiation safety committee and not putting in all the 22 positions that would be needed on that committee,'but just 23 limiting those positions in the rule to those that must be 24 included allows the licensee more flexibility in determining L
25 what other types of positions would be needed on that l
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committee.
So, we feel that the rule does provide that 2
flexibility.
3 DR. STITT:
View graph number seven, Louis is 4
going to talk about calibration of Brachytherapy sources.
5 MR. WAGNER:
Okay.
This one can be kept 6
relatively short.
One of the important points that the 7
ACMUI -- we had promised that licensees can rely on 8
manufacturers' calibrations, as long as that calibration is 9
a current ca'libration.
And we did not support the use of 10 sources that lacked an appropriate calibration, and that is 11 grandfathering those types of sources in.
And I think that i
12 the intent here is that all sources have an appropriate 13 calibration that's either traceable to NIST or traceable to 14 a secondary standard from NIST.
15 We did not that there were multiple commenters in 16 the APM, who supported verification of the manufacturer's
]
17 calibrations, but the ACMUI did not feel that it is 18 necessary to place this into rule spa'ce, although it does 19 not inhibit any of the members to satisfy for themselves the 20 verification on their own.
21 CHAIRMAN JACKSON:
Okay.
22 DR. STITT:
All right.
We're going into our final 23 topic.
Dennis Swanson, who is also rotating off the 24 committee, has been given the tesk o'i pulling this all 25 together.
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}
1 MR. SWANSON:
.I'm not sure about pulling it 2
together.
Actually, the committee sees a finalizction of 3
the risk informed performance-based rulemaking proce..,
as a 4
requirement for several additional considerations and 5
changes that the NRC must take, in order for~the rule to 6
function as intended.
7 For example, with the licensing program, Cathy 8
mentioned earlier that one of the areas where the agreement 9
states are not in total agreement with the proposed rule j
10 deals with, for example, the agreement states want to have 1
11 the licensee's procedures submitted and reviewed, which 12 implies approval of those procedures, as part of t
-e i
13 licensing function.
The ACMUI does not endorse the practice 14 of requiring pre-review -- NRC pre-review and approval of 15 the licensee's procedures.
The reason being is because what 16 you basically do there is you require the licensee to submit 17 a very specific set of procedures.
The NRC reviews and 18 approvec or makes changes in those specific procedures, ties 19 the licensees to those procedures, and what you have 20 fundamentally done is taken a performance-based rule and now 21 made it very dascriptive again.
So, it really goes against 22 the philosophy of performance-based rulemaking.
23 MR. MCGAFFIGAN:
Madam Chairman?
S'o, you all 24 support the staff in wanting to deregulate in this area, 25 compared to past practice, but you're worried about the ANN RILEY & ASGOCIATES, LTD.
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'1 agreement states continuing the past practice of reviewing 2
procedures?
3 MR. SWANSON-Well, we have a concern there, yes.
4 We definitely do support the staff in not requiring the 5
submission of procedures and review of procer?ures, as part 6
of the licensing condition.
Now, it doesn't mean -- to 7
address your concern, is when the inspectors go out, I mean, 8
obviously, they're going to have access to people's 9
procedures to review.
So, it's just not -- what we're not 10 doing is tying the people to a specific.
It gives the 11 flexibility to the licensee, again.
It's very important.
12 With regard to the inspection program, I believe I 13 said at the last ACMUI meeting, you're going to a very 14 different approach here.
You're going to a performance-based set of regulations that mandates thIat your 15
.16 inspection process also has'to be performance-based, which 17 is very different from the way inspections are done now, 18 where you have a very prescriptive set of regulations and an 19
. inspector goes in to see if you're following or not 20 following those regulations. 'Now, when an inspector has to 21 go in and make an evaluation of the overall performance of 22 the protocol, I think Dr. Paperiello hit it in his 23 discussion, you go in and you find one of two things.
The 24 inspector needs to be able to. judge is this still c 25 well-performing program, even though there may be these ANN RILEY & ASSOCIATES, LTD.
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noise level of problems.
2l CHAIRMAN JACKSON:
I have another appointment.
3 Commissioner Dicus is going to take over for me.
I would 4
like to thank the two of you for your services.
5.
MR. SWANSON:
Lastly, an interesting issue, I'm 6
not quite -- I'm not sure the committee is quite sure how to 7-address this or the staff, but it deals with the issue of 8
guidance documents and model procedures.
I think it's 9
important -- I think even the regulated community would 10 welcome and needs guidance documents and model procedures.
11 Where the problem comes in is, as we've seen in the past, 12
.you have a -- NRC publishes a guidance document or a model l
13-procedure and then that becomes a defacto regulation.
This 114 is the way -- this is our guidance' document; this is our I
l 15 model procedures; this should be the way you should be doing 16 this, which then turns into this.must be the way you're 17_
doing this.
And then all of a sudden, you take the 18 performance-based approach and made it very prescriptive 19 again.
And that's difficult.
And probably the best advice 20-we can give is for the NRC not to even get into guidance 21' documents or model' procedures, because you want to stay out i
22-of that pitfall, i-23 On the other side of the coin, again, on the other i
24 side, I think the regulated community probably needs some l
l 25' guidance and model procedures, and where are those going to i
1 i
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come from.
So, it's a problem.
2 MR. MCGAFFIGAN:
Madam Chairman?
3 MS. DICUS:
Go ahead.
4 MR. MCGAFFICAN:
The problem I see-there are 5
probably some very sophisticated folks out that there don't 6
need this and there's probably the smaller folks, who 7
actually benefit -- they would just assume not have to 8
invent procedures on their own'and they'd like to go to the 9
cookbook, although we shouldn't turn the cookbook into 10 handcuffs.
11 MR. SWANSON:
Yeah, exactly the point.
The 12 community is actually cheering for performance-base 13 regulations.
I think what we're going to hear, and I hear 14 from the community already is, yeah, but they don't give me i
15 enough information, okay.
S s, that's the problem you're 16 facing here, in going to this approach.
17 I'll just conclude by saying 1 t..tik there is some 18
-- ready to assist in all of these future dilemmas that 19 you're going to have.
It's easy for me to say it, because 20 I'm going off the committee.
21
[ Laughter.)
22 MR. MCGAFFICAN:
When do you all rotate off?
End 23 of June?
24 MR. SWANSON:
I believe in September.
25 MS. DICUS:
Who is the -- I thought you said there ANN RILEY & ASSOCIATES, LTD.
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was a third person rotating off?
2 DR. STITT:
Dr. Mel Pools, represents the research 3
community.
j 4
MR. MCGAFFIGAN:
But if you don't get off until 5
September, you're going to get to work on this for a few 6
more months.
7 DR. SWANSON:
I'm going on vacation from now until 8
September.
9 (Laughter.)
10 DR. WAGNER:
May I excuse myself?
I have to -
.I 11-have an appointment back home.
12 ~
MS. DICUS:
Okay; certainly.
Thank you, very 13 much.
Commissioner Diaz, did you --
14 MR. DIAZ:
Yes.
A couple of questions.
I think 15 we all realize that, you know, this is not the end of the 16 process; that, you know, just started really trying to use 17 risk aformation in this area, in a better and more
~18 efficient. matter.
The first question is:
these rules are, 19 in itself, I want to call them batch processes.
You know, j
20 you start them, you go, and then you got to stop sometime.
21 Does the committee feels that at the present time, with this 22 batch set, that the Part 35 is sufficiently risk informed to 23 serve this nation for the next five years?
Is that --
24 DR. STITT:
Well, certainly, in my practice side, 25 I've been living with the current standard for 20 years and ANN RILEY & ASSOCIATES, LTD.
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I like it a lot what we've been coming up with.
I think 2
it's very exciting.
3 MR. DIAZ:
Okay.
So, you think that it will 4
happen in a certain lifetime.
It won't decay very quickly.
5
.MR.
SWANSON:
Which is, in fact, one of the 6
advantages, I think, of going to a more performance-based 7
set of regulations, in that you start getting very specific 8
in the regulations.
Then, as new technologies evolve, 9
you're always butting up against your regulations.
And if 10 you can come up with a performance-based regulations, it 11 really allows again more flexibility at the licensee's 12 level; to start introducing and taking a look at these new 13 types of things or new approaches or better ways to do 14 things.
15 MW. MCBURNEY:
I'd like to add that as the 16
. representative of the state regulatory agency on this 17 committee, that we've been looking forward to this. rule 18
' coming out, so'that we can institute similar regulations in 19 our state.
20 MR. DIAZ:
Good.
That's a very satisfactory 21 answer.
And then,, a very simple question after that --
22 brace yourself.
23 MS. MCBURNEY:
Brace yourself?
24
[ Laughter.)
25 MR. DIAZ:
Having gone through the process, and 1
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I'd like your answer very much, and I think this is a good 1
2 effort that it gets us someplace in a certain life time, in 3
all of these areas that we look at, is there a particular 4
area that needs additional research or really, you know, a
5 deeper look, so that it can become more risk informed and 6
serve this nation better, for the next batch, when -- you 7
know, the next five years or six years, is there any 8
particular area that you believe that requires a deeper look 9
for the next go round?
10 (Pause.]
l 11 DR. STITT:
I think right now we're all sitting j
12 here thinking in our.own little worlds that we work most 13 deeply in.
My response to that would be it depends on how 14 we find that this actually works.
But, my impression is 15 it's going to be more further than what we've been with 16 before.
17 MS. MCBURNEY:
I think some of the emerging 18 technologies are going to be real challenging to how we 19 address the radiation safety aspects of those,'such as the 20 intervascular Brachytherapy.
21 MR. DIAZ:
Will the committee take note for maybe 22 not in the next few months that you're going to be so busy 23 dealing with this, but, you know, in the future, this is a 24 particular area that I think looks -- a further look, as you 25 go beyond.
Thank you.
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MS. DICUS:
Commissioner McGaffigan?
2
[No response.)
3 MS. DICUS:
Commissioner Merrifeld?
4 MR. MERRIFELD:
I don't nave any questions, but I 5
have some comments I'd like to make.
Is this the right 6
time?
7 MS. DICUS:
This is your last chance.
8
[ Laughter.]
9 MR. MERRIFELD:
This is my last shot; okay, today, 10 at least.
11
'I guess a couple of things I'd like to say.
You 12 know, I'm not a doctor and I'm not a physicist, but I'm a 13 lawyer, which is a profession.
And I know the difficulties 14 that lawyers have when we sit around and try to 15 self-regulate ourselves and decide how many hours of 16 continuing legal education that we want and how much we want I
17 to req 2 ire of ourselves.
And it's always a difficult issue.
18 And as we work through Part 35, it reminds me of that.
We, 19 as a commission, are doing things that have a significant 20 impact on doctors and how they interreact with their 21 patients.
And.we want need to be sensitive.
Obviously, you 22 have great concerns for your patients and we have 23 obligations of the law that we're supposed to do, as well.
~
24 I guess, as it relates to the person notification 25 area, I know that the community felt very strongly that this ANN RILEY & ASSOCIATES, LTD.
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'l is not an areas you feel needs involvement by us.
But, it 2
is an area, in which we have been involved with.
As was 3
related by Catherine, 99 percent of the comments received 4
was from medical professionals, not from the public.
And it 5
troubles me a bit, that we don't have a better understanding 6'
about where the patients really are on this.
And I think 7
that's something we're going to need to continue to work 8
through.
Because, it's easy for us to look at all the 9
comments on our plate.
But, ultimately, from our standpoint 10 as the NRC, we've got to be concerned about the health and 11 safety of the public, and that's something we need to j
12 continue to wrestle with.
13 A final comment I would make is -- and the 14 Chairman alluded to it, no, I've been very concerned that we 15 provide our staff with additional time to make sure that we i
i
' 16 wrestle through all of what were some excellent comments, 17 and making sure that we come up with a rule that makes 18 sense.
And though w= have ncthing to share today, I think 19
.there is -- we are grappling with timing issues and making 20 sure we deal with those comments appropriately.
And I just' 21 want to put on the record that -- I felt that was very 22 important for us to do.
23 MS. DICUS:
Thank you, very much.
Well, I'd like 24 to thank the staff, of course, and then very much thank each 25
'of the_ members of the advisory committee on medical uses of ANN RILEY & ASSOCIATES, LTD.
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isotope for our briefing today.
I know it will take -- it 2
takes time for you to come in.
It takes time to review the 3
large number of papers that you have to review.
And it's 4
truly appreciated that you're willing to give this time to 5
us, because it's very helpful, as we go forward.
And 6
particularly, we would like to thank the three members, who 7
are rotating off the committee for their service.
8 As Commission Mayfield and the Chairman indicated, 9
the Commission is currently considering the time line in 10 process for the development of the rule, and I suspect that 11 we should have a decision on that very shortly.
12 The Commission members always give serious 13 consideration to the views expressed here today and 14 providing guidance to the staff, in resolving these very key 15 iscues that remain to the revision of 10 CFR Part 35.
16 If there's nothing more from fellow commissioners, 17 then this meeting is adjourned.
18
[Whereupon, at 3:56 p.m.,
the briefing was 19 concluded.)
20 21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD.
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l
- s CERTIFICATE This is co certify that'the attached description of a meeting 4
of the U.S. Nuclear Regulatory Commission entitled:
i 1
d TITLE OF MEETING:
BRIEFING ON PART 35 RULEMAKING i
PUBLIC MEETING PLACE OF MEETING:
Rockville, Maryland i
DATE OF MEETING:
Thursday, March 25, 1999 was held as herein appears, is a true and accurate record of
'the meeting, and that this is.the original transcript thereof taken stenographically by me, thereafter reduced to typewriting by me or under the direction of the court reporting company i
Transcriber:
Natalie Renner Reporter:
Doua Swift 4
6
-l i
l i
l l
ACMUI ANNUAL COMMISSION BRIEFING i
l Judith Stitt, M.D., Chair Manuel D. Cerqueira, M.D.
Dennis Swanson, M.S., BCNP Ruth McBurney, M.S., CHP Louis Wagner, Ph.D.
i i
March 25,1999 i
l l
l
General Comments Part 35 Revision
= Rule is risk-informed, more performance based
- Occupational, public, and patient safety maintained
= NRC staff interactive and responsive
- ACMUI, subcommittees
- Regulated community
- Public meetings
l l
Training and Experience Part 35 Revision i
= NRC focus is on radiation safety i
- Training should be obtained in a clinical environment
= NRC recognizes training programs and speciality boards
= ACMUI endorses alternative pathway for j
training and experience requirements for AU, AMP, ANP, and RSO
- Encourages uniform national standards for training and experience i
i
l j
Medical Event (930.3045)
Part 35 Revision
= Proposed dose thresholds adequately capture
-events of concern
= Proposed dose thresholds will provide regulatory relief for low-risk events j
- Example: wrong treatment site
= Events occurring as result of patient intervention should not be reported to NRC
= ACMUI does not support any regulation requinng notification of physicians and patients as this is redundant to existing standards of care l
- k
Unintentional Exposure to Embryo / Fetus and Nursing Child l
(935.3047)
Part 35 Revision a Endorse staff proposal to address reporting in Part 20 rulemaking
~
- Special consideration mustbe given to the pregnant patient a Endorse 50 mSv (5 rem) as an ~ appropriate reporting level
- Will have minimal impact on the patient / physician relationship
- Will have minimal impact on current standard of care and cost
~
l a Statements of Consideration need to emphasize this is a reporting level, NOT dose limit L
e ACMUI does not support any regulation requiring notification of physicians and patients as this is redundant to existing standards of. care l
Radiation Safety Committee
($35.24) i Part 35 Revision 1
~
ACMUI endorses the proposed regulation to
~
=
require RSC for. licensees who have multiple types of uses under subparts E, F, and H
- Consistent with risk-based approach j
- Provides the licensee flexibility in program management i
i 9
Calibration of ail Brachytherapy Sources ($35.432)
Part 35 Revision j
i i
= ACMUI agrees that the licensee can rely on j
manufacturers' calibrations I
AAPM and multiple commenters supported i
verification of manufacturers' calibrations
= ACMUI does not support using sources that lack appropriate calibrations (grandfathering}
i j
W Implementation Challenges Part 35 Revision
= NRC's licensing program NRC's review and-approval of procedures Training of license reviewers NRC's inspection program
=
- Training of inspectors for performance-based inspections Role of guidance documents (model
=
procedures}
l l
e 4
l 1
i Revision of 10 CFR Part 35
" Medical Use of Byproduct Material" i
~. _ _ _. _.. _ _
i ggR REG 9 O
j q
E,
)
4 4
4*5 l
March 25,1999 Carl J. Paperiello Cathy Haney i
Briefing Outline Purpose of rulemaking l
i i
Global issues as identified by stakeholders l
Staff efforts since June 1998 briefing Key issues as identified by Commission and staff i
t Agreement State issues i
l i
I Purpose of Rulemaking
._z.._
' Primary Objectives:
i
{
Risk-informed, more performance based i
l i
Focus Quality Management on requirements that are essential for patient safety I
i Allow for timely incorporation of new modalities.
i l
2
Purpose of Rulemaking Continued Secondary Objectives:
Codify requirements for gamma stereotactic radiosurgery units and remote afterloader units (updated requirements)
Allow inpatient visitors to receive 5 mSv (500 mrem) on case-by-case basis
~
Require licensee to determine brachytherapy source output or activity prior to use Reduce recordkeeping burden 3
1 i
L Global Issues as Highlighted by Stakeholders i
f l
Role of NRC in Regulation of Medical Use of Byproduct Material:
- Adoption of recommendations in NAS/IOM Report
- Regulation of medical use of byproduct material limited to Part 20 and T&E requirements t
-Risk-Informed vs. Risk-Based Rule:
- Lack of formal risk ~ assessment
- General license for diagnostic nuclear medicine 4
t i
~
Global Issues as Highlighted by Stakeholders t
I Continued 4
Licensing, Inspection, Enforcement Philosophy:
- Performance-based vs. Prescriptive-regulation l
- Use of guidance document (model procedures) i
- Submittal and review of procedures i
- L"se of third party accreditation programs l
~
i 5
Actions Since June 1998 Commission Briefing i
July 21,1998 SRM issued to approve publication of proposed rul'e, medical poHey statement, and guidance document I
August 13,1998 Proposed MPS, rule, and associated guidance published Ibr 90-day comment period l
l'acilitated Public Meetings:
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August San Francisco, CA l
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September Kansas City. MO October Rockville, MD October lledibrd, NII f
i November 13,1998 SRM issued to approve extension of public comment period to 120 days i
December 16,1998 Comment period closed i
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Continued Interactions with Stakeholders and Advisory Committees-t February 17-18,1999 Facilitated pub.lic meeting with specially boards i
February 23-24,1999 ACMUI -Diagnostic Subcommittee Meeting l
t (ss35.100,35.200,35.300, and 35.500 uses)
February 25-26,1999 ACMUI Therapeutic Subcommittec Meeting
~(ss35.400 and 35.600 uses) f
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March 15-18,1999 CRCPD SR-6 Committee Meetmg March 24-25,1999 Full ACMUI Meeting Ongoing Part 35 WG & SG Public Meetings I
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l Key Issues l
i Training and experience i
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Reporting requirements
- Medical events
- Embryo / fetus and nursing child
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t Radiation Safety Cornmittee 1
Calibration of brachytherapy sources i
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- Training and Experience Proposed Rule:
i Focus on radiation safety
- Trainir.g requirements for diagnostic users significantly reduced
- Training requirements for therapeutic users maintained status quo
- NRC approved examination required to assess knowledge of radiation safety 1
--Preceptor required to affirm individual's: competency 4
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Training and Experience Continued i
Comments:
- Agree that NRC focus should be on radiation safety and not clinical proficiency 1
- Radiation safety training must be obtained in a clinical environment
- Variation in duration of training for authorized users in the diagnostic area j
- Training duration should be maintained status quo for therapeutic users (sealed l
sotece) and for endocrinologists
- Support and opposition for the requirement for an NRC approved exam l
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- Training requirements should be consistent between NRC and Agreement States
- Authorized users should not automatically be allowed to be RSO f
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i Training and Experience
..z Continued Staff Proposed Response:
- Wintain focus on radiation safsty
--Diagnostic uses - increased from proposed rule t
- Therapeutic uses - status quo
- FocusNRC or Agreement State approval of training rarogram l
- Practical radiation safety training should be obtained in a
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clinical environment t
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Medical Event ( 30.3045) j Proposed Rule:
- No significant changes in reporting threshold from current rule
- Added a dose threshokl for wrong treatment site
- Rule text added to exclude cases of direct patient l
l intervention
- No changes in time period for written report
- No changes in notifi~ cation requirements for referring physician and patient / responsible relative i
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Medical Event ( 35.3045)
(Continued) l Comments:
- Threshold should be raised
- Criteria for reporting wrong treatment site too restrictive r
- Patient intervention should be excluded from reporting; however, proposed rule language was too vague
- Reporting period (written) should be consistent with Part 20 (30 days)
- Rule should not require notification of referring physician and patient / responsible relative 1
13
Medical Event ( 35~.3045) -
Continued i
Staff Proposed Response:
- Staff continues to evaluate reporting threshold
- Reporting of events involving patient intervention l
required only.when the event results in unintended j
permanent functional damage to an organ or i
physiological system (as determined by.a physician) 4
- Revise reporting period to match Part 20 1
- Continue to require notification of reierring physician and patient / responsible relative t
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Unintentional Exposure to Embryo / Fetus and Nursing Child ( 35.3047)
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Proposed Rule:
Report unintentional dose to embryo / fetus that exceeds 5 mSv (500 mrem) absorbed dose Report any dose to nursing child that exceeds 5 mSv (500 mrem) TEDE that is result of an administration of j
f byproduct material to breast feeding individual Notify referring physician, pregnant individual or mother i
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f Unintentional Exposure to Embryo / Fetus and Nursing Child ( 35.3047)
. - - =
Continued i
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Comments:
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- Generally opposed to requirement
- 5. mSv (500 mrem) threshold will impact medical care
- Recognize standard of practice (reference MPS) l
- Not appropriate to require notification of referring physician, patient / responsible relative l
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L nintentional Exposure to Embryo / Fetus and Nursing Child ( 35.3047) 1 Continued Staff Proposed Response:
Option 1: Staff preferred approach Revise Part 20 to include requirement for reporting and modify Part 35 to i
include a requirement for licensees to comply with the Part 20 reporting
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requirement Maintain consistency within all NRC program areas l
Option 2:
Establish 50 mSv(5 rem) threshold for reporting--clarify that requirement is not a dose limit i
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- Maintain consistency with notification requirements in 35.3045
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Radiation Safety Committee ( 35.24) i Proposed Rule:
Deleted requirement for RSC j
Comments:
i
- Radiation protection professionals generally opposed j
to deletion of requirement for an RSC
- Diagnostic nuclear medicine physicians opposed to retention of requirement for RSC Staff Proposed Response:
f
- Retain RSC for medical institution where material is i
used for more than one therapeutic type of use
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Calibration of All. Brachytherapy Sources
( 35.432)
Proposed llule:
- Require licensee to. determine output or activity and source positionmg accuracy within applicators-Calibration measurements made by manufacturer i
acceptable if performed in accordance with rule
.l Comments.
Support and opposition for the requirement as well as reliance on manufacturer calibration l
I Staff Proposed Response-
- No change to proposed rule Do not grandfather all sources currently in use i
19
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Agreement State Issues Pre-review of procedures Role of authorized user Training and experience (AU, technologist)
Patient release Embryo / fetus and nursing child reporting H8cS Designations 20_ _ _ _ ____
O i
l Summary Summarized staff's efforts since proposed rule was issued for comment i
Summarized comments provided by stakeholders.on key issues i
Pro ~vided staff proposed position concerning the.
resolution of key issues i
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Request Commission guidance on staff 4
proposals 21
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t Training and Experience
. Proposed Rule:
Structured Educational Program Other Didactic (hrs)
Practical (hrs) l 35.100, Unsealed - uptake, dilution. excretion a
20 Physician, pecepton, e sam 35.200, Unsealed - imaging and locatin: ion 14 10 Physician, peceptos csam 35.300, Unsealed '- written directive required Hil
-10 Physician. peceptoe. es.un. 5 cases 35.400, Manual brachytherapy 200 5(M)
Physician, preceptoi, e s am.
lyr ACGMli pogram 2 yrs clinical cuuience 35.500, Scaled sources for diagnosis N
Ph,. sician,1)cntist. Paliatisse p
35.600 Therapeutic medical devices 2tM) 5(Ms Physician, peceptos, esam.
I yr ACGMI! piopiam.
2 yrs dinical esperiente I
PSO 2tM)
Piecepior. exam, I p or All AMP Piereptor, esam MS 2 ps ANP 7tM)
Preceptor ex.im 23
Stakeholder ~ Comments on T&E For Authorized User i
Society of Nuclear Medicine Hours not specified, exam only i
i American College of Nuclear Physicians 6 months /1200 hours, ACGME, no exam i
American Board of Radiology 4 months, ACGME, no exam Ameiican College of Cardiology /
American Society of Nuclear. Cardiology 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />, exam American Association of Clinical Endocrinology 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />, clinical, exam
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TRAINING AND EXPERIENCE REQUIREMENTS - Altemative Pathway Requirements *
$ 35.2v0 - Training for uptake. dilution, arut excretion studies
- 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> classroom and laboratory (Whtten Directive is not required - 35 100)
- 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> supervised pract. cal l 35.292 - Training for rmagi.eg and localization studies
- 80 Murs classroom and laboratory (Whtten Drective os not required ~5 35 200)
- 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> supervised practreat
- 580 hours0.00671 days <br />0.161 hours <br />9.589947e-4 weeks <br />2.2069e-4 months <br /> supervised experierice in a clinical environment 5 35 390 - Training for use of unseated byproduct matenal
- 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> classeoom and sahorato,y (Whiten driective is required - 35 300)
- 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> supervised practicat
- 580 hours0.00671 days <br />0.161 hours <br />9.589947e-4 weeks <br />2.2069e-4 months <br /> supervised experience in a clerucat envuonment
- 3 cases each use category requested 5 35.392 - Training for use of sodium iodide I-131 for which a wntten directrve is
- 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> classroom, laboratory and supervised practical required 3 cases each use category requested 5 35.490 - Training for use of manual brachytherapy sources (9 35 400)
- 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> didactic
- 500 b nuts practical
- 3 years ACGME program
$ 35.590 - Training for use of sealed sources for diagnoses (9 35 500)
- 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> classroom and laboratosy
$ 35.690 - Training for usc of remote afterloader units, teletherapy units, and garr:ma
- 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> didactic stereotactic radiosurgery units (9 35 600)
- 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> practical
- 3 years ACGME program 5 35.50 - Radiation Safety Officer
- OPTION 1
- 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> didactic 1 year supervised experience
- OPTION 2
- Authorized user for type of use g 35.51 - Authorized Medical Physicist
- MS
- 2 years experrence
$ 35.55 - Authorized Nuclear Pharmacist
- 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> structured educational program
- Training must be in NRC or A/S approved program. An AU under $$ 35.290. 35.292. 35.390. 35.392. 35 490. 35 690 nmst t>e a physician An AU under $ 35.590 may be a physician, dentist. or podiatrist. An AU. AMP, and ANP must also have a preceptor statement 25
4 Training. Program and Board Approval
- Applicat. ion submitted
.NRC baseline review 4
--Training Program 4
--- instructor qualification i
--- program content
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--- skills mastered
--Isoard
--- training program j
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.--- required casework I'
--- preceptor statement
- ACMUI review of staff recommendation
- Approval noticed in Federal Reaister and listed on NRC Website
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Resource Implications of Staff Proposal i
Initial Review: Four Tier Approach r
ABMS/AOA Board Approval-Ollice review 10 Boards x 20 hrs 200 hrs Non ABMS/AOA 130ard Approval-oilice review 10 Boards x 20 hrs 200 Component of ACGME/AOA Approved Programs - ofTice review 10 Programs x 20 hrs 200 Non-ACGME/AOA Approved Program
- office & onsite 10 Programs x 100 hrs 1000 Total 1600 hrs 1.2 lTli i
3 yr follow up 20 Boards x 10 hrs 200 20 Training Programs x 10 hrs 299 l
100 hrs 0.31 Tli I
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Medical Event ( 35.3045)
Proposed Rule:
Either A or B A.
Dose that differs from prescribed dose by more than 0.05 Sv (5 rem) EDE, O.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) SDE to skin AND Dose or dosage differs from' prescribed dose by more than 20%
Fractioned dose differs from prescribed dose by more than 50%
t B.
Dose that exceeds 0.05 Sv (5 rem) EDE,0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) SDE to skin
'FROM
~ Administration of wrong radiopharmaceutical, wrong route ol' administration, wrong individual or human research subject, wrong ticatment mode or leaking source l
28
f i
Part 35 requirements that impose 1
a burden on hcensee Written Directive Not Required - Unsealed
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t Basis Part 35 Requirement j
Medica!
35.6 Provisions for research involving human subjects Part 30 35.12 Application for license, amendment, or renewal Part 20 35.24 Authority and responsibilities for the radiation protection program Parts 19/20 35.27 Supervision j
Part 20 35.50 Training for Radiation Safety Officer Medical 35.55 Training for authorized nuclear pharmacist Part 20 35.60 Possession, use, calibration, and check of instruments to measure the activity of unsealed byproduct material Part 20 35.61 Calibration of survey instruments j
Medical 35.63 Determination of dosages of unsealed byproduct material for medical use Medical 35.69 Labeling Part 20 35.92 Decay-in-storage Medical 25.204 Permissible molybdenum-99 concentrations Medicai 35.290 ' Training for uptake, dilution, and excretion studies f
Meuical 35.390 Training for imaging and localization studies ~
- Bold items DO NOT apply to licensees using unit dosages _only 29
Part 35 Requirements that Reduce Regulatory Burdeu r
l Written Directive Not Required -Unsealed i
Basis Part 35 Requirement i~
Part 30 35.14 Notifications i
l Part 20 35.26 Radiation protection program changes Medical 35.63 Determination of dosages of unsealed byproduct material l
for medical use l
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l Part 30 35.65'
. Authorization for calibration and reference sources l
Part 20 35.75 Release ofindividuals containing radiopharmaceuticals or l
implants
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Part 20 35.92 Decay-in-storage 1
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Part 35 Sections Whers Requirements Have Been Reduced l
Written Directive Not Required -Unsealed t
Current Proposed Requirement 35.13 35.13
- Amendment not required for change in areas of use 35.22 35.24 RSC deleted l
I 35.27 35.27 Periodic reviews not required 35.50 35.60 Detailed calibratien requirements deleted 35.51 35.61 Daily check of survey meter deleted l
35.63 35.63 Unit dosage not required to be reassayed 35.67 35.67 laventory scaled source semi-annual rather than quarterly I
35.204 35.204 Moly breakthrough first clution rather than every clution 35.910 35.290 Training hours reduced 35.920 35.292 Training hours reduced j
General recordkeeping Recordkeeping requirements reduced 5
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j-Information Required for NRC License J
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L~nsealed Byproduct Material - Written Directive N ot Required j
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- NRC Form 313 i
- RSO name and qualifications j
- Description of facility and equipment
- Letter from management appointing RSO where RSO has agreed to appointment t
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