ML20217N280
| ML20217N280 | |
| Person / Time | |
|---|---|
| Issue date: | 10/21/1999 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 9910280166 | |
| Download: ML20217N280 (112) | |
Text
n p : r j u,i t U iil G ilti,L UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
Title:
BRIEFING ON PART 35 RULE ON MEDICAL USE OF BYPRODUCT MATERIAL Location:
Rockville, Maryland k
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Date:
Thursday, October 21,1999 Pages:
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y DISCLAIMER'
.This.is an unofficial-transcript of a meeting of the Unit'ed. States Nuclear Regulatory Commission held on
' October'21, 1999, in the Commission's office at One White Flint North, Rockville, Maryland.
The: meeting was open to.
.public attendance and observation.
ThisLtranscript has not
.been reviewed, corrected or edited, and it may contain inaccuracies.
(The transcript is intended solely for general
.infsrmational purposes. LAsLprovided by 10 CFR 9.103, it is notipart of the' formal.or informal record of decision of the matters' discussed.. Expressions'of opiniontin this
. c.
transcriptfdoLnot necessarily reflect final determination or
- beliefs.
'No:pleadingfor 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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11 UNITED STATES OF AMERICA 2
. NUCLEAR REGULATORY COMMISSION 3
OFFICE OF THE SECRETARY 4'
'5 BRIEFING ON PART '5 6.
RULE ON MEDICAL USE OF BYPRODUCT MATERIAL 7.
t
'8-
'9 Room 1F-16
'10 -
One White Flint North
'll 11555 Rockville Pixe 12-Rockville, Maryland'
,13 ~
)
14-Thursday, October 21, 1999 15 The Commission met in open session, pursuant to 16,
- notice, at 9
- 36 a.m.,
Gret.a J. Dicus, Chairman, presiding.
17 COMMISSION.R'S PRESENT:
18 GRETA J. DICUS, Chairman of the Commission 19, NILS J. DIAZ,' Commissioner (Via Speaker Phone)
.20' EDWARD'McGAFFIGAN, JR., Commissioner 21L JEFFREY'S.'MERRIFIELD, Commissioner l
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' PROCEEDINGS
-2
[9:36 a.m.]
3 CHAIRMAN-DICUS:
Good morning again, ladies and 4
gentlemen.
5:
On-behalf of my fot. low Commissioners, I would like 6
to welcome the staff from the Office of Nuclear Materials 7-
. Safety and Safeguards,'as well as representatives from the t
}
'8 Advisory Committee on the Medical Use of Isotopes.
9 Today's presentation will discuss many of the 10 proposed major revisions to NRC's 10 CFF. Part 35, the 11 medical-use of. byproduct material.
12 The. Commission's last briefing on this subject was 13 on March ~25, 1999, and since that time,.the staff has 14 continued toglisten and work with our stakeholders to modify 11 5 and to revise the draft final rule.
16
~Some of the more important issues that we will
_17 :
hear,about'today is the-training and experience requirements
'18:
for authorized users, reporting thresholds for unintended 19 exposures, and potential notification following a medical
-2CQ event'.
4 21f This draft final rule illustrates the ability by 22 staff,. members of the public, the medical community, 23
' licensees',- and the agreement states to be able to 24
! effectively 1 communicate'and' work together to develop a draft 25 final rule that is both risk-informed and performance-based, ANN RILEY & ASSOCIATES, LTD, Court Reporters 1025 Connecticut-Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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which is a vast improvement over the existing 10 CFR Part 35.
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-3:
More important, however, is the focus that the 4
rule continues to ensure the patient's health and safety, 5
while using'past operating experience from medical 6
facilities across the United States to make risk-informed 7
changes to the. regulations which reduce unnecessary 8
regulatory burden for_very low-risk procedures.
9 The many weekends, week-nights, and holidays that 10 the staff of the Division of Industrial and Medical Nuclear
.11
' Safety has worked have not gone unnoticed.
The staff is to
- 12.
be highly' commended-for these efforts in bringing a-13~
well-balanced and well-written paper to the. Commission.
It 14 is, indeed, a job well done.
15 Since August of 1997, seven facilitated public 16 workshops have been held, for of which were during the
'17 public comment period of the proposed rule.
.18-I note that the staff has made more than 20 formal 19 presentations to professional societies on the particular
-20
-items of interest to them, such as-training and experience, 21
'T&E, requirements.
-22 In addition, both the Organization of Agreement
$23 '
States and the Conference of Radiation Control Program
.A
' Directors were directly involved with the preparation and 25 development of the proposed and draft final' rules.
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-While the information presented today is quite 2
extensive-,Lwe will try~to.let you get through your 3'
_ presentations with minimum interruption and save our. general 4.
questions until the end of each of the two major
-5.
' presentations.
1
- 6 In other_words,-the staff present first and then 7
we.will have'a period of questions,.and_then the advisory I
8 committee-to'present, with'a series of questions, and if
~ ime allows, we might have everybody.at the table toward the 9
t
' 10 -
end.
11' If.there are additional questions, as I mentioned, 4
.12; we will trar t'o have everyone together at the end.
11 3 -
_Do_any of my fellow Commiss'ioners.have.any' opening I
remarks they wish to express?
'14 15 Commissioner-_McGaffigan.
16.
COMMISSIONER'McGAFFIGAN:
I want to echo-your
_17 compliments to the staff.
-I think they've done an 18
' outstanding job here.
'I think this is a major improvement 19' over the existing.Part 35, 20
- I.also want to.thank ACMUI, the members who put in z21
.a large; number of hours plowing through large numbers of
'22 drafts,.and I.think we'have a good product.
Is it a perfect 23-product?'
No.
There will be dissatisfied people.
But it is
-24
'aLvast. improvement over'the previous Part 35, and.I 25 compliment the staff for.the effort.
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1 CHAIRMAN DICUS:
I thank you for those comments.
2>
Commissioner Merrifield?
13' COMMISSIONER'MERRIFIELD:
'I'd.like to join in that 4;
sentiment.
i
- 5~
Cathy Haney, Diane Flack, and the rest of the Part I
26' 35 team' have done an outstanding. job.
I know there are some 7.
areas where some'stakeholders still have concerns.
We'll EL work through those,-but overall, it's a tremendous amount of i
9 effort on the part of the staff, and we do recognize that 10 and thank you.
11 CHAIRMAN DICUS:
We do really, very much, as all
-12 of us have mentioned, appreciate the effort.
We know this 13 has been a major' effort.
I know how long this.has been on 14-the.booksi and I: also appreciate the~ work of ACMUI and what 15 -'
you have.done in giving your time to this effort.
16.
.So, without'any further ado, Dr. Paperiello, if 17L you would introduce the staff, and we will get started.
18 PR. PAPERIELLO:
Thank you, Madam Chairman and 4
19' Commissioners.
i 1
20-As you noted,.the. purpose of-the meeting today is 2 11
.to brief the Commission on the revision of Part 35, medical i
22:
tuse of byproduct material.
23:
Before the staff starts the actual briefing on.the 24-issues associated with rule-making, I'd like to note that l25
' the draft final 1 rule before the Commission is the l_
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- 1 culmination of extensive effort that began in 1993, when the 2
Commission examined the issues surrounding the medical use 3
program.
4 In 1997, the Commission stated that it supported 5
the ongoing medical use regulatory program, with 6
improvement, decreased oversight of low-risk activities, and 7
continued emphasis on high-risk activities.
8 That direccion from the Commission has resulted in 9
a draft final rule that significantly reduces the 10 requirements for medical use licensees, especially for 11 diagnostic uses.
12 In addition to other Commission guidance over the 13 past two years, the staff has also benefitted from extensive 14 interactions with the advisory committee on medical uses of 15 isotopes, medical professional societies, and other 16 stakeholders, and in particular, as we heard from yesterday, 17 the agreement states and the Conference of Radiation Control 18 Program Directors.
19 The staff has kept the Commission apprised of the 20 key issues associated with rule-making through SECY papers 21-and previous briefings.
22 Our presentation today will focus on the issues 23 where the staff has requested Commission guidance, in SECY 24 99-201, in order to finalize the rule-making.
25 However, the staff is prepared to discuss other ANN RILEY & ASSOCIATES, LTD.
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issuesnin the draft final rule, as_well as the public 2
comments on the proposed rule and'the comparison of current l
3-requirements in.Part.35 with the requirements in the draft 4
- final' rule.
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Members of'the Commission's ACMUI will follow 6
their comments -- with their comments on the staff's-l i
'7.
proposed resolutions of the key issues.
i 8
Following~the formal presentations, the staff will 9
be glad to respond to questions.
10.
Seated the table with me are William Kane, 11 LDirector of the' Office of Nuclear Material Safety and
- 12
= Safeguards; Dr. Donald Cool, Director of the Division of
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13 Industrial, Medical, and Nuclear Safety; and-Cathy Haney, 14 Chairperson-of the'Part 35 Working Group.
1 15 Ms. Haney will be presenting the staff's position i
16 on the key' issues.
17 Following the staff's presentation, Dr. Manuel I
18.
Cerqueira, Ms. Nekita Hobson, Ms. Ruth McBurney, and Dr.
19
. Louis Wagner will present~ the ACMUI's position on the key
'20' iissues.
21 Cathy Haney willLnow-begin the staff's briefing on 22 Part 35.
23 MS. HANEY: < Good ~ morning.
Thank you.
24
-If'I.could have view-graph number one, I would j
R2 5 '-
like to first go-through'what I would like to discuss with l
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-the. Commission first.
2 That would be just a brief discussion on the 3
background, some of the extra information that is included 4
in SECY 99-201, identify the key issues for the Commission's 5'
consideration, also look into our implication -- what we 6
consider to be implications of implementing the rule in the 7
licensing, inspection, and enforcement program, and then, 8
finally, to give you our best estimate of the time-table for 9
completion of this project and also the resrurces needed to 10 complete the task before us.
11 Next view-graph, please.
12 With background, as has been indicated, we're 13 really starting back with the March 20, 1997, SRM from the 14 Commission'that asked that we revise Part 35 into a more 15 risk-informed performance based regulation, and again, as 16 indicated previously, we have had continuous interactions 17' with the public, with stakeholders, agreement states, 18 non-agreement states, and the ACMUI, and that's why I 19 believe we were ab.le to really put this package before you 20 with considering all these comments.
21-It was very advantageous to us to have this 22 interaction with the stakeholders.
23 The next view-graph -- I'd like to note just a 24
. couple of things on this.
25 Obviously, the main reason for providing you with ANN RILEY & ASSOCIATES, LTD.
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~SECY 99-201 was to provide.the draft-final rul'e language,to-
-2:
you, but-we alsoEused:this as a mechanism for closing out
.m
.3 previous requests.from the Commission on some of the 4
. outstanding' issues.
5 One'such example would be the need.for a formal 6
risk assessment, which we'll. discuss in a minute.
7-The otherithing was to provide the Commission with 8
our. understanding of'where the draft final rule package 9
differs from that of.the SR-6 committee, the SR-6 committee 10 being a committee.that's.under the Conference of Radiation Control Program Directors.that is developing a suggested
-12 stateLregulation for the medical area.
11 3-In. view-grahh four, there are several issues that
.14' we would like to highlight for the Commission's decision.
15 They'are notedLon this slide.
16 There are numerous otherm issues associated with 4..
f17 -
this. project, but knowing that I couldn't have you for eight
.181
. hours to talk to youLabout them, we identified just the key 19 ones that we wanted to put before y$u,.the first one being 20 4
21' CHAIRMAN DICUS:
Do you think you can get all the
- - 2 2 -
' key issues just.in eight' hours?
. 23:
MS. HANEY:
No.
-24t
' COMMISSIONER.MERRIFIELD:
That's reading them.
125E
-MS. HANEY:
It's not telling you the background.
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COMMISSIONER McGAFFIGAN:
Madam Chairman, I just 2'
'mightinote -
.I forget whether we've'said it already.
This 3
-paper-has been available to the public since early August, 4'
and we'veibeen' pouring over it and~getting briefed on it bit 5'
'lzr bit.
6 So, this'is the tip of the iceberg of the 7
' Commission's involvement in this paper and, I think, the L8
'public involvement, as well.
9 COMMISSIONER MERRIFIELD:
I'd actually, just for a 10l
'second,' -like'to jump'in on that.
'11 I think all of the Commissioners, or at least all 12
'the Commissioners present, have also had separate briefings
.13 f rom the staf f cnr this,: and there are a number of questions 14-that I'had that'have~already been answered, and I'll try to 15 give'the flavor of some of those today, but you know,
-16
.normally, I'might have more questions than perhaps I may 17 have today, and that's'not'as a result of not having 18-questions,-it's a result of having answers.
19-CHAIRMAN DICUS:
I'think we're all in the same 20 boat.
I do'have-the questions that I'll ask on behalf of 21' Commissioner Diaz, but we're going to let you go ahead and 22
-get.through.
You're going very well.
l23 MS. HANEY:
Thank you.
L24 All right.
25]
The first topic would be the need for a risk ANN RILEY & ASSOCIATES, LTD.
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assessment, and the issue here is whether we need to perform 2
a formal risk assessment.
3 After the March briefing, the Commission askt: us 4
to provide the pros and cons associated with doing a formal 5
risk assessment at this time.
6 The pros, obviously,,would be that there would be 7
additional information and that it would be responsive to 8
some of the public comments.
9 However, there are several down-sides to doing it 10 at this point, and this has to do with the significant delay 11 in providing a final rule to either the Commission or 12 putting a final rule in the Federal Register.
It also would 13 be significantly resource-intensive.
14 We believe-what we've provided you with is a 15 risk-informed rule and that we have made significant 16 reductions in unnecessary burden associated with the use of 17 byproduct material.
18 Another thing to note, too, is that some of the 19 data that.would be needed to perform a formal risk 20 assessment would be problematic, and this goes back to l
21 information that appeared in the NAS -- the National Academy 22 of Science Institute of Medicine report, when they did look 23 at'NRC's role in regulating in this particular area.
24 As I said earlier, we have made significant 25 reductions in unnecessary burden.
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I 12 1-LJust to give you'an' example of-a few of them for 2
consideration would be as the reduction in.the radiation 3-
-safetyLeommittee, your, diagnostic users.would no longer be 4~
-required to have a-radiation safety committee, some.of the 5
. quality assurance tests that are done on generators.
We 6
have reduced _ requirements'in for surveys in the department, 7
, relying on1Part 20 as the governing regulation,. as compared EF to Part'35,'and also, we've made some' changes in the 9'
requirements forJwhat a licensee would need to -- when they 10 would need to come in for a license amendment.
All of those 11 things considered, we do think that the rule has reduced the
'12-
' burden -- unnecessary burden.
'13-Moving on to the next view-graph on radiation 14' safety committee,-this was a very interesting issue, and 15
'really, the issue is.what is the impact of deleting the 16' radiation safety committee?
Does it reduce the licensee's 17.
-radiation safety program effectiveness?
18-We took into' consideration th'e risks associated 19 with:use of. material at the facilities, as well as public 20-comments.
21-Public comments really were from the standpoint of 221 medical physicist, radiation safety officer, they believe a 23 veryl strong'importance for the safety committee, where 24 others believed that'it was morelimportant to have
-25 flexibility.
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1
-Our rec >mmendation would be that the radiation L2 safety committee.is only required if there are two or more 3
different types'of uses~under the sub-parts E, F,
and H, and 4
what:that translates into is, if you're.using unsealed
- 5-byproduct material for therapy, something such as I-131, 6
remote after-loaders, gamma stereotactic radiosurgery units, 7
teletherapy, or manual brachytherapy.
If you have two or 8
.more of those types of units, then you would need to have a 9
radiation safety committee.
10 Also, in subpart H
- subpart H is really medical 1
11' devices, and we believe that, if you have two or more units
'12 under that particular subpart, that.it was important to have 13 a radiation safety' committee.
14 For example, if you had a remote after-loader, 15 those ' tend tx) be in your oncology department.
If you had a 16 gamma stereotactic radiosurgery. unit,- that tends to be in 17 your neurosurgery units.
118 The. concept of -
the need for a radiation safety 19 committee is to bring departments together so that they can 12 0 ~
speak, and-that.'s why.we believe that this was important 21
-here.
J2 2,
We also believe_this is a very good example of 23
'where we considered risk in reducing requirements.
'24 LNext.. view-graph, seven, has to do with training 25 and' experience requirements,.and this.was probably the
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-1 biggest. issue'that we had to address under this particular 2
rule-making.
It also received the most comments.
i 3
We believe that our regulation should be focused 4
on the safe handling ~of the radioactive material and that 5
it's important to note that being a licensed,-authorized 6.
user under NRC,-in the case of a physician, is~saying the 7.
individual is competent to handle materials safely, it is 8
not assessment of their. clinical proficiency.
~
9 We do have some global recommendations in this 10 particular area, and that is, as:I said, we focus on 11
~ radiation safety, and also, we rely on the preceptor form
.12
'and the hours of - "that are required by the rule to. assure 13 that the individual has safe-handling of the material.
14 Slide seven, please.
Thanks.
15:
If you remember'back in the proposed rule, we had'
~16 proposed that an exam be required, and also, in March, when 17 I spoke with you,.we asked that -- and we were considering 18 NRC getting into a. situation where we would approve training 19 programs,.but when we went back and looked at the 20 implications and the assurance that we would gain from both 21' of.those particular items, we felt that we really didn't 22 need to go to that extreme, that it would be sufficient to 23-just require -- increase the number of hours in some areas 24 of training over that in the proposed rule and also to rely on the p'eceptor form.
25.
r I
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Now if you can move to page eight, the other thing 2'
I would like to point out about changes in the training and
~
3
' experience is that, in the case of the diagnostic users of 4
-material --'that's the 35.200 use'of material -- that we no 5
longer have the breakdown in the number of classroom hours 6
and the number of work experience hours.
We've grouped that 7
together and asked that-the individual have 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of 8-training, total, and we specify in'the rule what we would 9
want the individual-to know.
10 LSo,.this is, again, a step at us becoming less 11 prescriptive and focusing in on performance, telling the 12-licensees what we want them to know.
13 The other particular item that is a change in this 14:
' area is that we have' reinstated the current requirements for 15:
the use of strontium-90 for eye applicators.
16 Again, an example of looking at risk in this 17-particular area,'at the proposed rule we asked that the 18 hours2.083333e-4 days <br />0.005 hours <br />2.97619e-5 weeks <br />6.849e-6 months <br /> be increased to that required for radiation oncology.
19' However, we were concerned about the impact on the
'20 profession by doing this. We were~also aware that there were a significant
- 22-unumber'of misadministrations in this particular area, but we
-23 L
asked ourselves whether increasing the training was really 24' the. solution to the problem, and our suggestion is that, in 25
'this case,-it may not be.
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The cause'of the misadministrations were sources 2-thatLhad not been calibrated. properly and had not been 3.
decayed.
L4' So, we did put a prescriptive requirement into the 5
rule.that the sources would -- the licensee would need to 6.
have.them calibrated.to NIST and also that an authorized 7
medical physicist perform the calculation.
Again, we recognize :Ut is'a prescriptive 8
9
. requirement,.but because-of the risk associated with the use 10 of.this material,. we do 'believe-that it is warranted.
11 Moving on to view-graph nine, this issue has to do 12 with the reporting threshold for unintended exposure to the 13 embryo / fetus and nursing child.
- 14 '
The issue here-is'that we do have a requirement to
-15' report to' Congress when an embryo / fetus or nursing child 16, receives an exposure. greater than 5 rem or if there is a 17
' situation where there's be'en unintended permanent functional 18
' damage-to an organ.
19 As a. result., we proposed at the proposed rule
'20 stage that the threshold be slightly less than the AO 21
' criteria that we come.-- that our rules require reporting at
'22:
500 millirem, rather than 5 rem, so that we would hear about 23 information in advance of having to report it Congress.
24 We'have changed -- based on public comment, staff
-25 is recommending that we increase the level from that ANN RILEY & ASSOCIATES, LTD.
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1 proposed in'the' proposed rule to the 5-rem limit, which
- 2' would put it right.at the limit of the AO criteria.
3 Now, if we go on to view-graph 10,.some of the 14 reasons that we are doing this are because of the impact on 5-the medical profession if the threshold were left at 500 6
millirem.
I 7
We received comments to the point that, even in a 8
diagnostic area, there are a :significant number of-9
. procedures that would trip the 500-millirem level, and as a 10 result,-the practice of' medicine would have to be changed 11 somewhat-to address this, because the question is would it 121 be adequate any longer just to merely ask the patient if 13 they were-pregnant or would we get into a situation where 14
'they.were having to do pregnancy tests all the time?
15 Another concern would'get into the cost of who
)
"1EI would be paying for-this, whether it would be covered for i
insurance or not.
Would the patient be able to'go to the
)
177 i
18 samel facility.to get the blood-work that they~would need to 19 that they would get the nuclear. medicine procedure?
-20 Also, it could actually impact the care of the
]
21
-individual, because the physicians might be leary to do this 22 procedure, and therefore -- because'they might have to i
23:
report to NRC -- and.therefore order tests that would not be
- 24 '
- asfgood'as.the nuclear medicine test' as a diagnostic tool.
'25 We consider.this:in light of the risks associated ANN RILEY & ASSOCIATES, LTD.
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with exposure between 500 millirem and 5,000 millirem, and 2-what was -- you know, was the baby or embryo / fetus going to 3
be negatively impacted?
4 We considered reports put out by the National 5
Council on Radiation Protection and the American Association 6
of Physicists in Medicine, and based on the information in 7
that document, we felt justified in coming back to the 8
Commission'with the request to raise this level to 5 rem, 9
also realizing that this is a reporting requirement and not 10 a dose limit, and that is a very important distinction on 11 this particular item.
12 Lod Wagner, who is on the ACMUI, is prepared to 13 discuss the effects of the -- on the embryo / fetus and the 14 nursing child between these two particular levels.
15 This is one of the areas where I would like to 16 point out that there is a concern -- that there was a 17 concern raised by the SR6 committee in this area, believing 18.
that the dose limit should not be at the 5-rem level, it 19 would be better if it was-at a lower threshold.
20 View-graph number 11 gets us into the next topic 21 area, and that is notification following a medical event or 1
22 exposure to the embryo / fetus or nursing child.
23 The issue here is should there be an NRC 24 requirement that would require the licensee, referring 1
25 physician, or the authorized user to notify either the l
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patient,.the responsible relative, or the mother if an event 2
did occur?
3-The public comments that we received were very 4
much against a requirement from the standpoint of NRC having 5
a' requirement,- indicating-that it is the standard of car, 6
' standard of practice to inform the individual when an event 7-
'such as this has occurred.
8 However, we-have chosen, based on previous 9'
Commission positions., I guess is the best way to put it, 10 that we would continue to_ require this notification in the 11-rule.
12 We did, however, provide in the SECY paper some 13 alternative rule text for this parcicular area, and that was L14' in ~ response to the SIU4 that we received af ter the March 15-briefing.
.16 So, what I would like to just run through real 17 briefly_with you are the pros and cons of the alternative 18-text,. recognizing that the alternative text would only 19
-require that the licensee certify to us that the individual 20 would told.
21 We would go no-further.
We would not care whether 22 a' report was given_to the mother nor would we ask if a 12 3 report was given; it's merely licensee certify to us that 24-you told them.
L25 From the pros associated with this alternative, we
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20
'l do believe-that it is more consistent with the medical
'2' policy. goals.
We believe that it does put a greater 3.,
reliance on the patient / physician relationship.
4 We~would like to recognize that it is consistent 5
with the Federal l patient --.with other Federal patient 6'
' notification require.nents, that.being FDA's,.and then it
'7
.also -- one could argue that it is stepping more into a more 8
risk-informed eituation than the. current text is right now.
9
.However, there are cons associated with that, and
< 10 they are that it does not ensure that the patient is 11 notified, is fully informed of the event.
That's probably 12 the biggest 1one',
'13 The other is that it is not consistent with other
-14?
NRC requirements, that being the Part 20 requirements that 15:
require the licensee to notify a member of the public or an 16 occupationally-exposed individual if they receive doses in 17 excessiof the limits.
18
.So,-as I.said,.we have --..the draft final rule text has the current requirements in it,.but you do have the 1
19 20 alternative text, if you would like to consider that.
21 There are two additional concerns raised'by the 22 SR6 committee.
231 One has to do with criteria for releasing 24 individOals, slide-14, and that'leing that there are two
'25:
cases.where -- two. items that they would suggest going into ANN:RILEY--& ASSOCIATES, LTD.
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1 the suggested state regulations.
2 Under this particular item, the states would have
- t
'the authority to'be more restrictive in this because of the 4
compatibility designation associated with it.
5 One is that the authorized user would be required 6
to sign the document that. authorizes the release of the 7.
individual.
8 The other is that they would like to include a 1
9 statement that the' licensees would have' continued
' 10 responsibility.for contaminated' articles even though the 11 patient had been released under the regulations.
12 The other issue.has to do with safety precautions 13 associated wit; brachytherapy treatments-.
The draft final 14 rule you have before you would allow a licensee to quarter
~
15' two patients in the same room that had both received 16 unsealed byproduct material for a therapy situation.
q 1
1~7 We believe that the dose that one would be
'18'
- receiving:from the other.would be inconsequential in light 19
.of the' dose-or exposure.that they-are receiving as a result i
i 2 0 '.
of their treatment.
Therefore, we see no reason to preclude 21 lthat.
22 However, the SR6 committee would so require a j
)
1 23 private room.
24 The'othertis that.they would like to see some
]
s 251
'additionalisurvey' requirements in their equivalent to Part l
1
~
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22 l1 35,-where-we fee 1~ confident that the licensee's radiation 2
safety program under Part 20 would adequately address this.
13
" View-graph 15 covers real briefly.the implications 4
in the licensing inspection and enforcement program.
15 -
We do believe that' medical licensees should 6
continue to receive a specific license because of the risks
~
7-associated'with the use of the material.
8 We have, however, made changes in what
-9 information, what amount of information.must be submitted to 10.
us in order to receive that-license.
~
11 Under the current rule and current policies, 12 licensees need to. submit procedures to us for handling 13)
. material safely,~for their training programs, for how
=14-they're going to calibrate their dose calibrator, very 15 specific procedures, and that becomes part of their license 16'
' application.
' 17 -
What we are proposing is that information'no 18 longer come in to the licensees.
19.
The:only,information that we would need would be 20 their name, _their mailing address, who's going to be the-21 authorized user, the training and experience for the
~22 authorized users, T&E-for their radiation safety. officer, 23 and some information on their equipment, and that is all 24 that we would be looking at, but the comments that I
'25 received were: fine, Cathy, that. sounds' great, but you're 1
l ANN RILEY & ASSOCIATES,:LTD.
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84 - b3
23 1-going to hit us on the inspection,-you're come in and look 2
at that, so all you're doing is shifting your resources from 3
licensing to inspection,'and that.is.not'the case.
j 4
Our plan is-not'to go into' reviewing these
.5 procedures at.all,.really,1during an inspection, unless the 6-situation-warranted it
'for example, we were out 7
investigating a medical event or some contamination getting 8
out'into a unrestricted area.
]
9 In that. case, we would go in and look at these 10 procedures.
11 So, it doesn't relieve'the licensee from having 12 them as part of their safety program, but from the 13 standpoint'of'NRC reviewing them, we would not be doing 14 that.
15 Also, there would be some needed revisions to the a
E16 enforcement policy from a standpoint of there'are some 17 changes in terminology.
18 So, we'would need to make some minor changes in 19 some.of the appendices'for the enforcement policy, and that 20 would really befit, because there are:-- any changes in the 21' overall enforcement policy are being. handled under a
' 2 2' smparate effort.
23 View-graph number 16 addresses'the resources and
-24 time-table'for completion of the' rule.
My bect guess is
- 25 that it-will: take approximately three FTE to complete the l
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rule-making, recognizing that, when we do come back to you, 2
we will be providing you with the medical policy statement 3
in final, the NUREG document, which is the guidance 4
document, a complete Federal register notice, regulatory 5
analysis, and an OMB package.
6 As far as the due date for that, or the timing to 7
do all of that, once we get that back to you and the rule 8
'would get published, we're looking at probably an effective 9
date of early 2001.
10 That is assuming that we really -- we're waiting 11 for direction from the Commission to go forward, and then 12 we'll have about three to four months to do that.
13 Following that, we'll need a maximum of 90 days to 14 get OMD clearance on the package.
The rule would be 15 published mid-next year, with a six-month effective period.
/
16 With that, I've gone through prepared remarks, at 17 least.
18 CHAIRMAN DICUS:
Okay.
19-Let me make a couple of observations.
20 First of all, I want to thank you for a succinct 21 yet thorough review of where we are at the moment.
I really 22
, personally don't have very many questions, because in fact, 23 I think they've been answered in the slides themselves and 24 from a pre-brief that I had.
I will make a couple of 25 observations, though.
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The first one is on slide seven, and it's the last i
2 sub-bullet, where it says NRC recognition, especially l
3 boards, and I simply want to point out we are talking about 4
recognizing, not approving.
5 MS. HANEY:
Correct.
6 CHAIRMA DICUS :
So, there is a difference there.
'7
.And then I would go to slide 15 and the issue in 8
the third bullet of inspections and the issue that you 9
brought up as to whether or not we would be transferring 10 licensing burden to inspection burden.
11 I just want to caution the staff to be sure that 12 we don't do that, to be sure that we don't get inspection 13 creep _in this arena, that we are careful,.that our review of 14 procedures and inspection is related strictly to when it's 15 found to be a reason that we need to go in to review those.
16 So, on behalf of Commissioner Diaz, who_we did 17 have problems having in on this briefing -- and I know he 18 has a great deal of interest in this issue -- I would like 19 to ask a question on his behalf, and it goes to slide eight, 20.
and his question is, "As noted in the SECY paper and as 21 discussed yesterday at the OAS/CRCPD briefing, which we did 22 get into Part 35, there is a concern about the number of 23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br /> of required training for the use of I-131.
Would you 24 please explain why 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of training" -- and I realize 25 you_may have already done this, but I think, for the record, ANN RILEY & ASSOCIATES, LTD.
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for.him -- '"is sufficient'for the safe administration of j
.2
- I-131 ? "
That's question one.
.3 "Should there be different requirements for large
- 4 institutions versus endocrinologists' offices?" question 5
number two, and question number three, fin "In your 4 6 discussion,.would.'you'please address health ~and safety L7
- issues.of. workers.and the public in this regard?"
8' MS. HANEY:.Okay.
Let me address-them in order.
9 I-think I can do that.
10 We did -- if you go back to where we were before
/11 the proposed rule,~we had recommended that the number of 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> for the endocrinologist be increased, and that was 13,
based on looking at hazards associated with the use of I-131 14 and recognizing'that misadministrations have occurred with 15
.use of I-131"and noting that'the way the rule was currently 16 written, there were'some hands-on performance sort of 17
' requirements that.were not included in the requirements that 18-wereLspecific_to the;endocrinol'ogist.
So',-we had-19-
' recommended.an increase.
20 We did have'a lot of interactions with the-21' endocrinology community,1where'they described in detail 22; their training programs and how they handled material and
~23 asked that we look closer at.the records -
the
-24
- misadministration-records associated with use of I-131 and
-25 reconsider whetherf an-increase.in this particular. area was
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1 warranted or not.
2 We did go back and do that, and according to our 3
records, there were two misadministrations of I-131 that i
4 could be attributed to an endocrinologist as compared to 5
another. type of user, and really, what we've been-hearing is j
6 look at the track records.
7 If material -- if things have been working well, 8
why do you need to change them, and with that in mind, we 9
went back and we really didn't feel like we had the basis to 10 change the requirements, to increase the hours for the 11 particular_ users.
12 We did modify the ruling somewhat to make sure 13 that there were requirements in the rule for some of the 14 more performance-oriented -- surveys, things like that -- to 15 explicitly get them into the rule as compared to knowing 16 that it takes place but it was not necessarily required by 17
_the rule change.
18
_The other thing that -- change that we mauc in 19 this area was the greater reliance on the preceptor.
20 Whether you're looking at someone preceptoring fcr 21 use of I-131 or for a remote after-loader or a r'adiation 22 safety officer, for that instance, under the current 23-scenario the preceptor is merely saying yes, the individual 24 took the training period.
That's all that he's signing to.
25-Under our new proposal is the preceptor is ANN RILEY & ASSOCIATES, LTD.
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28 1-actually.sayingL the individual-took the training, but in his 21 or her professional opinion, the individual is competent to
'3.
handle the material safely.
4' So, because of that, we really felt that we could 5
leaventhe: training requirements at the.same level as they
'6 are1right now'and not feel like there was any impact on 7
either.the patient or the occupational workers or the public 8
'as a' result of thete particular hours.
9 The second requirement about whether there should 10 be different requirements for the large institutions versus
-11 the -- you know, whether you could have a different 12 requirement for the endocrinologist -- if you asked me this 13'
. question a year-and-a-half ago,.I would have said no -- or I 14
- would have said yes, based on that information, but again, 15
-because.of the benefit of having this level of interaction 16' with the stakeholders, I really do think that there is a 17 need for separate requirements in this particular area.
18..
In the larger institutions, you have individuals 19~
.that:are -- you're supervising larger staff, so they're 12 0
' handling more material,.so more things can go wrong, and
~
21 they need to be able to have a little bit more experience to 22 be able to-make sure that either things don't go wrong or 23-
.that, ifithey do go wrong, they know how to handle it, also l
l-24 recognizing that there are certain -- ic's almost a -- well, L
25 it is a specialty, that they're only using iodine, majority ANN RILEY & ASSOCIATES, LTD.
Court Reporters
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9
+
29 i
-; 1~
Jisfonly used in capsule form and, therefc"e, cutting down on 2
'thel problems with' potential contamination, and you're only~
3' Ldealing with one organ, and based on all of that, I think 4
it's just aLseparate category forJthis particular type of' 1
5 user isJwarranted-.
16 With regards to the question about did we consider 7.
the' health and safety associated with use of the workers and 8
the public --Land I'm going to assume this is specific to
- 9 iodine -,yes, we did,' and I believe that the regulations 1 01 are in place that would provide'for that.
11-Section.35.75, which has to<do with the release-12 criteria for when a patient can be released, is dose-based, j
L13 and it is -.and the release is based on the dose to the maximally'ex'osed individual.
14f p
~15 So, from that' standpoint,- I think that that
'16 addresses.one set of populations, really your public l exposures, j
- 18 Part 20-would address'your occupational exposures,.
j J
19-and'.again, the licensee still needs.to, comply with Part 20, 20' so all'of those requirements are stil? in place.
21
!So, because of,.you know, the-combination of Part 22 35 Land 25, I: think that the; public health and safety, as
-23.
= well as' occupational health and safety, in protected by the 1
24 draft. final rule.
i 25:
CHAIRMAN DICUS-Okay.
Thank you for your 4
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responses.
2 I know that the SR6 committee did have concerns 3
with this and did surface them later.
4 Commissioner McGaffigan.
5 COMMISSIONER McGAFFIGAN:
I'm going to try to go 6
through basically the SR6 concerns.
I think I come down on 7
the staff's side on all of them, but I just want you to have 8
a chance, publicly, to talk about some of them.
9 The first slide he had yesterday -- and I'm 10 talking about Mr. Walter from Alabama -- had to do with 11 written procedures, and he basically, unlike our rule, wants 12 to have all of the procedures submitted as part of the 13 license and, you know, a fairly prescriptive requirement, 14 rather than relying on spot inspections as needed.
Tell me 15 why you came down the way you came down, as opposed to the 16 SR6 committee.
17 MS. HANEY:
From the standpoint of the procedures 18 being svi.dcted at the time of licensing?
19 COMMISSIONER McGAFFIGAN:
Yes.
20 MS. HANEY:
The procedures are really the 21-licensee's responsibility.
We set the regulations, tell 22 them what they need to do.
We have requirements for 23 assuring that they're properly trained, and that sort of 24 information we would review.
-25 So, we're looking at saying that you've got ANN RILEY & ASSOCIATES, LTD.
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properly trained individuals who know what they're supposed 2
to do because it's in the requirements, and we don't need to 3
.look any-further at the time of. licensing.
4:
We would expect the licensees to develop the 5
procedures that are'needed to comply with the regulations,
'6 and our review is not.necessary.
7 Also, i? gives the licensees maximum flexibility 18' in those areas where we think, because of the risk, that
-9 it's warranted.
110 Any procedure that we've reviewed, they're tied to
'11.
in their license.
So, they cannot cha a that procedure
-12 unless they come in for a' license amendment, which is yet 13 another process they have to go through in dealing with NRC 14
.So, this elimina'tes that need.
15 So, it has to Lth flexibility for the l
>16
- licensee, but yet, at the t une time, -I don' t think we ' re 17
~ reducing:any oi the safety considerations.
18.
JCOMMISSIONER McGAFFIGAN:
I would think that OMB,
-191 when it did the paperwork reduction review --
20' MS. HANEY:
They'll like us.
21-
. COMMISSIONER McGAFFIGAN:
They'll like you on this
' 2'2 -
particular' item.
23 Authorized user duties was-a slide he had 24.
yesterday, and he claimed there's a Catch-22 because there 25' Lare no-duties specified in Part 35.for the authorized user ANN RILEY & ASSOCIATES, LTD..
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r 32 1-unless a written directive is required.
2 It sounds like a technical point that he was i
3 making, but have you talked to him about this and can you 4
explain why you are where-you are?
5 MS. HANEY:
Sure.
6 We have tried not to interfere with medical 7
practice,- following the medical policy statement.
So, from 8
the standpoint of selecting the patient, in my view, at 9
least, is crossing that line a little bit too far.
10 I:do believe that the needed duties are in Part 11 35.
There is a requirement for the individuals handling the 12 material, say at the technologist level, to follow the 13 directions of-the authorized user.
14 So, in essence, that is setting up a 15
' responsibility for the authorized user.
I mean maybe it's a 16.
de facto one, but it is there.
17 The reference to whether there was a Catch-22 in 18 the rule between our requirements really has to do with the 19 unique situations that is in hospitals, where we -- the 20 hospital is our licensee.
21 However, the authorized user is usually a contract 22
_erployee, and now you have got a contract employee in a 23 situation where they're directing a member of the licensee's 24 staff.
25 So, the relationship between 35.11 and 35.27, ANN RILEY & ASSOCIATES, LTD.
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33 1
which he cited in'his view-graph,uis really needed to make 2
sure that NRC -- that the licensee is clear that "he,re 3
ultimately responsible for the safe handling of the material 4
but yet making sure that, at the technologist level or the 5
user level, that they are aware that they have to follow 6
what the authorized user says.
7 COMMISSIONER McGAFFIGAN:
Let me just mention --
8 and'I1 don't want to go through them 'all, because you've'gone 9
through several in your presentation.
Technologist T&E --
10 he says the SR6 will include technologist training and 11 experience requirements which we don't have and I don't 12 think at any point in the process we ever had.
So, this is
'13 a new idea.
.14 Why have we not considered training and experience 15 requirements for technologists?
i 16 MS. HANEY:
.The working group considered having 17 training and experience requirements for technologists back 18 in-late '97,Lon one of the first drafts that we issued.
19-
.We' received a-lot of early comments from the 20
. technologists on this particular area, and those comments 21 really went along'the line.of they were.very concerned that 522 if.we put~a requirement.for the training and experience in L23-our rule and it was only focused on radiation safety, that 12 4 '
'we might actually.be negatively impacting the medical practice,'the handling of it', because. licensees are always ANN'RILEY'& ASSOCIATES, LTD.
1 Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036-(202) 842-0034
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going to be looking for ways of saving money, and if our
(
2 rule says you-only need 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> of training to handle the 3
material at a technologist level, they're going to go out 4
and look for individuals that have 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> of training, 5
and the technologists really are doing -- going much further 6
than just the radiation safety handling.
7 There's imaging.
There's positioning.
There's a 8
lot more than just the world of NRC that the technologists 9
have to do.
10 So, the techs are very concerned that that might 11 be an impact of having that'.
12 Also, the Part 35 working group stepped back and 13 said, you know, who's responsible here, and it's the 14 licensees that's responsible for the safe handling of the 15 material, not at the technologist level.
16 There are requirements in the rules for the 17 licensee to make sure that their technologists have -- well',
18 actually, let me take it broader.
19 The licensee is responsible for assuring that 20 their staff is properly trained, and under that particular 21 requirement is we're making sure that the techs get the 122 experience to -- and the training to handle material safely.
23 So, because of that, we don't really think that
.24 it's needed in Part 35.
25 COMMISSIONER McGAFFIGAN:
I'll leave it there.
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- 1:
.There's some_other questions I'll pursue with the ACMUI.
2-CHAIRMAN DICUS:
Okay.
- 3:
Commissioner Merrifield.
4 COMMISSIONER.MERRIFIELD:
Going to slide five, I 5
just' wanted;for you to expand a bit.
'6 You' mentioned'that there were significant costs-7-
and staff impacts related to performin7 a full-blown risk 8-assessment.
9-TI was wondering if you could perhaps expand a j
~
10
-little bit more on-that in terms of detail, because I-think 11 there are some out there who wanted us to do that, who 12 expected.us to go through a risk-based rather than a 13
. risk-informed' process, and I think having a little better 14 understanding of why.we chose the direction we did for those 15 reasons would:be helpful.
'16
'MS. HANEY:
Okay.
17 ur' estimate is'that,.in' order to'do a formal risk 18 assessment and to carry that into regulations could te2e 1
19' approximately 10eFTE,to do, and we're looking at five years
-1 20 to complete that project, again, we're looking at.a very.
-21 thorough' assessment here.
It also could take several 22' million dollars tordo that.
' 2 3
Our concern'is that.this. rule does provide I
24 immediate relief to some of the' diagnostic users, and if we
.25
.were-to wait and hold this rule-to complete that, we ANN RILEY & ASSOCIATES, LTD.
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actuallyLare negatively impacting the stakeholders, because-2.
they_would not be allowed to start-implementing and reducing 3
their requirements right-now, because they'd be waiting for 4
another five. years while we completed this risk assessment.
5-COMMISSIONER MERRIFIELD:.There's nothing about 6
moving forward with this rule that would' preclude-outside 7
stakeholders on their own from obtaining additional 8
information and bringing that'to us later on, after this
.9 rule-making is completed, for us to consider additional 10 changes, is'there?
11 MS. HANEY:
Nothing.
12 COMMISSIONER MERRIFIELD:
Okay.
13 On slide 11, you spoke about the concerns relative 14 to.some of the notification requirements, and you mentioned 15
'something, that there was significant -- we received a 16 significant number of public comments related to this 17 requirement.
18 To what extent.did those public comments include 19-ccomments of persons other than those who would be impacted 20-by the rule change --
i.e..,
individuals not in the medical 21 community?
22
-MS. RANEY:
I don't believe we received any 23 comments from-your' average patient commenting.on whether 24 this'was a good requirement or a bad requirement.
I mean we 25
'didn't get-comments either way.
We didn't hear from that ANN RILEY & ASSOCIATES, LTD.
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i 37
.1 population'at all.
2 We do have a' patients rights-advocate on the ACMUI
- 3:
-that:will be -- when-they.get to this -- when they come up 4'
to:the table, will be discussing it with you, but we did
~
l 5
hear,.during the process, at the public meetings -- we had 6
two patients rights advocates come, and they did not believe 17 there should be an NRC requirement for this type of -
for 4
8' the notification.
-9 lTheir view was.this was between the patient and 10'
.the physician and it was just not needed to have the NRC 11 Jstep in,.bu't-they were, you know, two' people sitting at the
'12
' table.
13 COMMISSIONER MERRIFIELD:
I'm reminded of 14 experie'nce that I'had working in the United States Senate 15' dealing with.-- although it's a completely different issue-16-dealing with right-to-know requirements under some of our
.17 environmental laws, and I know: changes'to that which would 18 take away;the'right of individuals to be aware of materials 19 brought with'it significant comments, j
20 Whether the-greater patient community was aware of
'21 what~we were doing or not remains to be seen.
I leave that J22:
for'further comments.
23
.On slide 14, one of the; issues that was raised 24
- yesterday.when we met with'the agreement states, one that 25; Commissioner McGaffigan didn't me'ntion, related to the i
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possibility -- the impacts that this would have on 2
individuals in the medical community or -- I guess the 3
example that was used was nursing homes.
4 If you had multiple patients who were in a nursing 5'
home who were subject to these release criteria, how would 6
that impact a nurse or other nursing home attendant who had 7
to deal with multiple patients and multiple exposures over 8
the course of a year?
9 Did we factor that into our thinking?
10 MS. HANEY:
This was factored into the thinking 11 when we revised the rule back in 1990, the early '90s, when 12 we did go from an activity-based rule to a dose-based rule, 13 and the belief at that time, and as continues on, was that 14 the requirement stating the 500 millirec to the maximally 15 exposed individual was sufficient to protect the public as 16 well as any_ individuals.
17 Now, in the case of, you know, the nursing home 18-situation,'I can't tell you that we actually went back and 19
-- I have not gone back and looked at the reg analysis or 20 the supporting statement for that rule specifically on were 21 releases to a nursing home considered.
22 I would like to believe they were, but I can't 23 tell you that they were definitely.
24 COMMISSIONER MERRIFIELD:
Thank you.
25 CHAIRMAN DICUS:
Let me follow up on slide 11 on ANN RILEY & ASSOCIATES, LTD.
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.the' patient notification, and I'm asking, again, on behalf
- 2 of Commissioner Diaz, and this question'is actually to the 3
General Counsel on his behalf.
It has to do with the 4~
alternatives, verbal. notification of patient as' opposed to 5-written notification.
6
-Does the Office of General Counsel have specific 7
. concerns.with the alternative that would allow verbal 8
' notification?.
9 MR. BURNS: ~ Any one of the alternatives, I think 10 the question really is whether a rationale can be developed 11 for it'and can be supported.
So, from that sense, there's 12' not a' legal bar to: alternative formulations that are under 13 consideration.
14 The alternative here, one would have to, I think, 15c 1 harmonize in terms of the rule-making notice and the E16 Commission's ultimate adoption of the alternative, would i7
-want to harmonize it with other notification requirements t
18 the Commission has,.because~if you look at Part 19 and Part 19-
.20 for both routine exposures, occupational but also public 20 exposures, both routine as well as extreme or accidental 21
. exposures, there are notification requirements that we 22 ;.
routinely require to be made-under those regulations.
23 So, I think the answer:is really that the 24 Commission could adopt alternatives.
It would have to 25=
. articulate the rationale for them, and the special case ANN RILEY &. ASSOCIATES, LTD.
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would probably be you'd have to articulate the rational in 2
the context of other notification requirements the 3
Commission has adopted.
4 The other thing we noted, too, is although it's 5
not -- it doesn't drive us particularly as a' requirement, 6
the Commission can look at -- there are notification 7
requirements in another Federal statute, the Mammography 8
Quality Standards Act, which are comparable or in the same 9
ballpark, let me say, as, I think, what the staff's proposal 10
'is, but alternatives could be considered.
11 CHAIRMAN DICUS:
Okay.
Thank you.
12 I think, in the interest of time, we'll go ahead 13 now and hear from ACMUI.
14 I want to thank the staff again for your 15 presentation, and we may, in fact, have additional questions 16 after the ACMUI presentation.
17 DR. CERQUEIRA:
Good morning, Chairman Dicus.
My 18 name is Manuel Cerquiera, and I'm going to be presenting the 19 presentation for the ACMUI.
20 We have other members of the committee that are 21' currently present:
Dr. Louis Wagner, who is representing 22 the' nuclear medicine and the physicist community; Nicky 23 Hobson, who is the patient rights and care advocate; and 24 Ruth McBurney, who's representing the agreement states.
25 What I'd like to do, as Cathy Haney also ANN RILEY & ASSOCIATES, LTD.
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1 demonstrated, was to.just go through our presentation.
2 1You've had the overhead slides available to you, and at the 3
end of-my' overview, then we'will take specific. questions on
[
'4
.the. specific' issues.
t 5
'If welcould have.the briefing outline, we will
.6~
make'some genera 1Ecomments,.we'will then deal with the 7.
radiation safetyJcommittee, the training'and experience 8
'issuei medical' event, unintentional exposure-to the
~
9 embryo / fetus and a nursing child, patient notification, and 10' then some challenges to implementing the Part 35 revision as 11' we understand'it at present.
12 In terms of my general comments, I"think that all 13' of^us have had an opportunity to share in this effort and 14' feel that it's.been a very thorough process that I think,.in
-15 general, has been.able-to maintain the safety to the users, 16
.to the public, and to1the patients.
171 It is really'taking.a step in the right direction 18 towards decreased the regulatory. burden for the regulated 19
' community, and I think as:a result of this very thorough 20 process, it~will definitely increase the public confidence
'21 in'what we as medical professionals are current doing, and.I T22-
.think, as a result of all these changes, we've also managed 23 to increase the efficiency and the effectiveness of the
~
24 radiation regulations.
25
'Again, it's our belief thatEthe draft rule is 1
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risk-informed, it's more performed-based, and as a result of 2
the process, we've really been able to get the stakeholders 3
involved.
4 The meetings that were held with public input and 5
all the letters and things that were reviewed thoroughly by 6
the staff as well as the_ committee have really taken the 7
public input, both the user community and as much of the 8
public as we could get, and as a result of that, I think 9
it's allowed us to make those four points up front that 10 we've been able to achieve as a result of this.
11 Slide three, please.
12 In terms of the radiation safety committee, I 13 think Cathy has done a very good summary of our feeling son 14 this.
15 The ACMUI endorses the draft rule which basically 16 allows institutions that have higher risk to require some 17 degree of safety oversight from the radiation safety 18 committee'while at the same time allowing the single office 19 practice that's providing diagnostic services to have a more 20 limited overview with the radiation safety officer but
.21 without the need for a radiation safety committee.
22 So, I think that this -- it's a prospective system 23-that will allow the assurance that safety in appropriately 24 provided at the various facilities.
25 Slide four.
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The training and experience has in many ways been
-2.
one.of the more debated issues, and I think the current 3
proposal maintains the safety aspects and deals with some of 4
the issues that have been brought forth by the community 5'
while at the same time allowing the opportunity for emerging 6
technologies to be regulated at a later point in terms of 7
the training and experience requirements.
8 It's the feeling of the committee'as well as the 9
staff that the-training needs to be obtained in a clinical 10 environment; because all of these will be set up in a 11 clinical programs, and it's very important to make certain 12 that the training is going to be obtained in situations
'13 where it's going to be used.
14 We've endorsed the alternative pathway for
-15 training and experience for the AU, AMP, ANP, and the RSO, 16 because the preceptor statement we feel will provide some 17.
assurance.
This is not just a mere signing off.
We really 18 feel that the people that are doing the training assume 19 responsibility t,o make certain that the material is fully 20 mastered.
21 We believe'that the.NRC recognition of the 22
~ specialty boards is going to be a very important process.
23 It sort of. widens.the opportunity for people who have not i
24 taken traditional programs but who have gotten the i
25 appropriate clinical and radiation safety experience to ANN RILEY & ASSOCIATES, LTD.
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il
~become~ authorized users.
[2 LThere was some concerns expressed by the committee 3-Ein terms of nationalLstandards-for training and experience.
- 4'-
I think the agreement" state. meeting yesterday -
some of 5
,these issues may-have been brought up,._but currently there's 6
' 31 agreement states.
7-
- So,.we'are' implementing a national policy that's 8?
going to be, in~effect-in a"much smaller percentage of
.9 states'than'those.'that'are actually going to be regulated, 10; and;if_you look'at.the' current regulations,-they vary 111 considerably from state to state, and even within states, 12 there are some regulations that differ within New York City.
13' versus New York State.
14
.So, it's the feeling of the committee that a 15 uniform national policy, certainly with1regards to training 16'
'and experience,. would be very important,-especially for the 17.
people thatLare coming lin through the' alternative pathway, l181 through the experience requirements without the boards, that
.19 ;
by'just allowing the -NRC states to have these new 120:
modifications, people involved in training programs are 121-.-
1 going to be very much stretched'in. order to provide training
~
22 that will allow people to' practice wherever they have the 123-opportunity to do so.
'24 We also feel that -- and this was an issue that 25.
- came-uplseveralstimes in terms of emerging technologies.
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'l Intravascular brachytherapy for prevention of restonosis was 2'
one thing that camerup, 'and this is a technology where the 3
information as to which of the multiple alternatives will 4
actually be available for clinical use is not known, and it 5
wasn't felt that there was sufficient data at this point to 6-set very definite training requirements.
7-
'3 5. 1 0 0 0, which deals with.the emerging technology, 8
will allow some of these techniques to be evaluated and 9
recommendations made specific for the applications that are 10
' developed.
11 Slide five.
12 The medical events -- the ACMUI endorses the dose 13 thresholds that are in the draft final rule.
We feel that 14 this adequately captures the events of concern and safety.
15' The dose thresholds will help to reduce the i
16 unnecessary regulatory burden for things such as wrong 17-treatment site or patient intervention that are not really 18 within the control of the medical community.
19' Events. occurring as a result of patient 20 intervention should not be reported 1to the NRC unless j
21
_ unintended permanent functional damage to an organ or 22 physiological. system has occurred.
23 Slide'five.
-24 Unintentional exposure to the embryo / fetus or the 25-nursing child -- I think Cathy has gone over in some great ANN RILEY.& ASSOCIATES, LTD.
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deal -- there were specific questions related to this.
q 1
2 It's the feeling of the committee that the risks
)
3 are'really very low and that the 5-rem reporting limit is j
4 probably too high, but given all of the issues and concerns 5
around this, the ACMUI endorses the 5-rem as an appropriate 6
reporting threshold.
7 We feel that, again, it has minimal impact on the 8
patient and physician relationship in this format and has 9
minimal impact on the current standard of car and cost, and 10 some of these issues will be brought up during the 11 discussion.
12 Slide seven, notification following medical event 13 or exposure to embryo / fetus ano nursing child -- and again, 14 this was brought out.
The ACMUI does not support any 15 regulation requiring notification of physicians and 16 patients, as this is redundant to the existing standards of 17 care for medical practice.
18 You know, all of us believe that these types of 19 things are essential for good medical care to be performed, 20 but they're not regulated in other areas, and we feel that 21 certainly diagnostic levels of radiation, that the current 22 practice of medicine standards are effective.
23 The alternative rule language provided by the 24 staff -- it was preferred over the existing requirements.
25 We heard some of the legal counsel issues that were brought ANN RILEY & ASSOCIATES, LTD.
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up related to this.
2 And the final overhead is really the 3
implementation challenges to this -- the revised Part 35.
4 We feel that it is very important that the NRC and 5
the staff begin the process of recognizing the medical 6
specialty boards that have sufficient requirements and 7
assess competence in radiation safety and knowledge of 8
radiation for approval for becoming~an authorized user.
9 If we wait until this rule is fully implemented, a 10 lot of the regulated community and people coming out of 11 training will have some difficulty in getting appropriately 12 licensed.
13 We also believe that, as Part 35 is being revised, l
14 there's going to have to be a considerable mind-set within 15 the NRC reviewers and inspectors on how they perform their 16 evaluation, and you know, we're really, at this point, i
17 trying to make it risk-based, and areas that are very 18 low-risk, that-really don't contribute to the safety of the 11 9 public, the users, or the patients, really need to be i
20 recognized as such.
21 We also feel that it's very important to develop 22 the guidance document.
23 We don't see this as de facto regulation but, 24 rather, provides the user the opportunity to see -- look at 12 5 some models, especially those less sophisticated sites.
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'l This.willLgive themLsome informed basis upon which to send
~ 2..
their. applications.
3 We believe, also, that implementation of the rule 4
will continue'to require s.)me -- quite a bit of oversight 5
- from the ACMUI committee.
6
- We.were joking' yesterday that we think we've gone 7
through the hard part, but once these rules become 8
implemented,~there will obviously be quite a bit of 9
contention into the actual implementation.
10 LSo, this really concludes our presentation in 11
" terms of the recommendations 1of the ACMUI, and at this time,
~
12 I'd like to open it for questions from the Commissioners.
-13.
CHAIRMAN DICUS:
Okay.
Thank you very much.
14 Let me begin with a question on implementation.
15
.It's on, behalf of Commissioner Diaz, but I think it would be 16 my. question, as well.
17 The' intent _is to try to have these new rules --
18 when and if, but I think I can say when this becomes a final 19 rule, to hEve the new-requirements in place within six 20 months of the rule becoming final, and I guess my question 21-
.is,-isLsix months sufficient time.for the specialty boards
- 22
and the NRC'itself -- and the NRC may: Want to come to the 23
. table ~on.this one, as well -- to process the necessary
.24
= certifications and:actually' meet the requirements of the 25-
' rule?
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49 1-Can we:do this in six months?
From your 2
perspective, can it be done in six months?
And then I might 3-ask.the staff:if they think'they can be prepared to do this 4
in six months.
5'
.DR.- CERQUEIRA:
Again, in terms of reviewing the 6
. boards, I think that there's probably a limited number of
,7
.boardsfthat are going.to apply, and I think as Cathy pointed 8
out in her overhead, with~enough FTEs, we should be able to 9s get thisidone; L10 I think the interested. boards have already mer l
11 e with ~ the: NRC, and they have_actually initiated within'their L12 own organizations steps for applying.
13
- So, I1think that six months is adequate.
14 You'know,'this rule has been evolving over several 15 years, so it's not completely novel.
So, I'think six months 116-would be-adequate time.
17 CHAIRMAN DICUS:
- Okay, i
18 Cathy?
i l
- 19:
MS. HANEY:
Six months is adequate time for the j
i 20 licensees _.to' adopt.the new regulation, recognizing that the' 21 majority;of what's in the rule is actually a reduction.
So, L22 they're not going to -
they'll have to go back and just 23
~ review.some procedures,'but they're not going to have to
-2 4 -
start over from scratch"in developing new procedures.
25i I would say that the one key, though, is the early l
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recognition of the boards.
2 I do not think six months is effective, is going 3
to give us enough time to actually get the boards approved, 4
and then there's still an issue of whether ve would need to 5
notice in the Federal Register and things like that that we 6
need to consider.
So, that's why we're asking for this 7
permission to start the recognition process early rather 8
than later.
9 CHAIRMAN DICUS:
What about getting the guidance 10 documentation together?
11 MS. HANEY:
Well, our plan right now is that, when 12 the package comes back to you, that we would have the 13 guidance document with it, and we have to make changes to 14 it, but it matched the proposed rule.
15 But we will need to update it to match the final 16 rule and then just to go through and double-check and make 17 sure everything is in there and what shouldn't be is not in 18 there.
-19 So, I think we have adequate time for that, also.
20 CHAIRMAN DICUS:
Okay.
21 I want to ask one more question on behalf of 22 Commissioner Diaz, and we're in very good shape time-wise, 23 so I think there will be sufficient time for some 24 discussion, but this has to go with this kind of ticklish 25
. issue of the unintended dose to an embryo / fetus in excess of ANN RILEY & ASSOCIATES, LTD.
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the 500 millirem, and the question is to both the staff as 2
well as ACMUI, again on behalf of Commissioner Diaz, and 3
this was brought up, of course, yesterday, as we know, by 4
Mr. Walter of the SR6 committee at the briefing we had.
5 His question is that, in the case of this -- of 6
unintended dose, how would requiring that licensees report i
7 unintended doses in excess of 500 millirem hinder the 8
practice of medicine?
There was some indication that 9
perhaps it would.
10 DR. CERQUEIRA:
Lou, do you care to comment on
'11 this?
12 DR. WAGNER:
Sure.
I think there are several 13 issues with regard to this.
14 First of all, as the rule currently stands, it is l
l my understanding that, if there.is a report to the NRC, 15.
16 there obviously has to be a written report to the patient.
17 Now, in terms of medical practice, what is a 18 physician going to do in terms of medical decisions with 19 regard to a dose like that?
Okay.
20 Likely what he's going to do is go tell the 21 patient, look, we reviewed everything, we don't have any 22 real concerns here or any real risk, we're not going to do L23 anything, we're not going to take any intervention, we're 24 going to go on, but there's got to be a written report to 25 the' patient.
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~
)
-1
-Then patient's going to'get this report and say, j
l 2
okay, the NRC says I got to tell;you all this.
That's going
)
3 to.really tear down the confidence of the patient with their 4
' physician.
That is a problem.
5 That.is:one-essentially area.where'there would be 6
a' lot of. difficulty with regart to the patient-physician f7 relationship.
8'
.In: addition,;if you have this reporting rule, the 9
NRC carries a lot of weight, and it can impact medicine by
' 10 -
making some examinations not available to patients merely 11 for the intention of. avoiding this potential.
12
.The question is what's unintentional, and the only 13' place where'it's really going to become a big. issue is the 14 early pregnancy, when they're,not going to do that the 15 patient'sfpregnant, patient comes back later and says, oh, I 16 happened t.o be.about four days past conception-the day I got 17 that examination, okay?'
18 So, that's going to cause them a problem in regard E19 to now I've got;to report this to the NRC.
Well, maybe I 20l don't want to report that-to the NRC.
Maybe what I ought to 21' do is'just notido these examinations.
f22
'That will have an influence.
It will change the
~
- 2 3 -
way people' practice medicine.
So, there is a difficulty 24 Ewithuragard to'that.
25 Furthermore,-what is going to happen with regard' ANN RILEY'& ASSOCIATES, LTD.
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~ to pregnancy testing?
Are we going to require more and more L
J2 pregnancy testing'for women when they come in because they
)
t 3
.might be pregnant?
'4 We-might catch a few more, but pregnancy testing
}
l L
5
-in itself is not foolproc
-l we still might not be able to
~6
~ catch'all of.them.
What att se going to do now?
Instigate li f
7 a 10-day rule?
)
l 8
Are we going to say you have to have had your 9
menstrual-period within-the past two weeks before we're 10 going to do this exam on you?
Now we're going to delay it.
11 Okay, we delay it.
L 12 We find out later on, after.we delay to find out 13-if she.is pre oant, that'indeed she is pregnant.
Then we u
l 14:
'so,-oh, my gosh, I wish-I'd done the study early, because 15
.now she's pregnant and she's at a certain stage which had
?16
. advanced her risk-time.
17
.So, there's lots of areas now where this is going
.to have an impact on medical care as we currently practice 18.
l 19 Lit.
i l
-20.
-Now, if weilook at the essence as to how medicine 21
.is practiced now with regard to standards of screening and 22 how'we take actions on things, they're in conflict with this 23 rule and this reporting-at 500-millirem, and it will have
]
24 those1 kinds ofichanges on medicine, and I think that we have 12 5 to come'to an agreement on a reporting mechanism that ANN'RILEY &' ASSOCIATES, LTD.
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applies across the board for all the stages of pregnancy 2
that is not going to impact the current standards of 3
practice in medicine but will at the same time satisfy the 4
need for the reporting requirement.
5 CHAIRMAN DICUS:
Okay.
6 DR. CERQUEIRA:
As, I guess, the only practicing 7
physician on this group, as a practicing cardiologist and 8
nuclear medicine physician, I feel it incumbent.upon myself 9
to notify patients when things happen that are not planned 10 or are potentially dangerous, and as a cardiologist I can 11 give medications that are 10 times more harmful than any 12
. radiation risks that could be given, even at therapeutic 13 doses, and there's no regulation for my reporting 14 misadministration of medications -- beta blockers, 15 intravenous, or so on.
16 But I think within the practice of medicine, we 17 basically regulate our own reporting of these things, so 18 that this reporting mechanism is really beyond anything else 19 that exists within the practice of medicine.
20 The risks that are involved, I think we've all 21 agreed, certainly for diagnostic, are very low.
So, I don't 22 think it really adds to the safety of the patient.
23 It does create some difficulty in the 24 patient-doctor relationship, and I think, you know, 25
. physicians are currently doing this as part of the standard ANN RILEY & ASSOCIATES, LTD.
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l 1
of care for medical practice, and to have it regulated like
)
1 2
this doesn't really further the patient benefits.
3.
CHAIRMAN DICUS:
I know Commissioner Merrifield 4
wants to weigh in.
I've got another part of the question.
5 COMMISSIONER MERRIFIELD:
It's very short.
It's 6
actually in the' form of a statement in response.
7 CHAIRMAN DICUS:
Okay.
8 COMMISSIONER MERRIFIELD:
I've heard this argument 9
before, and I'm sympathetic to it, but the response I would 10 give is this:
11 If we. sat around the room and we had a group of 12 medical professionals and a group of scientists and experts 13 in the NRC, I think we would recognize that, indeed, in a 14 comparative manner, the risks associated with the uses of 15 some of these radiological materials and the risks 16 associated with some of the use of the other chemicals that
.17 you utilize is vastly different, but that's the issue that 18 we have to deal with with all of the regulatory areas that 19 we deal with as an agency.
20 When you compare some of the risks associated with 21 some of the areas we do with chemical facilities out in the 22 United States, there are some far greater risks in the 23 safeguards, the security area, far great risks relative to 24 thoca facilities than the reactors that we regulate, and we 25 get the same complaint from our reactor operators, gee, you ANN RILEY & ASSOCIATES, LTD.
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'1 have all these' security requirements on us, and I got a 12 chemical facility.two blocks down the road that has nothing, 3:
and-that's a:far greater danger,-and the fact is it's true,
.and the reasonit'sitrue is because there is a.much greater 4L n
'5
.public sensitivity to the~ areas in which you practice and we 6
regulate than therelis with chemicals, and I think that's a 71
- factiof? life-that we all have to recognize.
-8
.I mean,.like I said, I think, sitting around a 9
room,.we could all recognize that perhaps there ought to be 10 more' balance, but I think;there are-external factors both to 11
-thefregulated community'as well-as the regulators that 12 affect the manner in which we havefto go.
13 CHAIRMAN DICUS:
Cathy -- oh, do you want to 14.
respond?
15 DR. CERQUEIRAi Well,.again,-I think we've had 16 this. discussion, you know,-at our previous briefing in 17-March, and you.know, we're very sensitive to the public 1
18 perception that surrounds radiation'and, certainly, the
~19
- failure to' report,'given~all the public' scrutiny that has 20 gone.on, but if we really try to make this, you know, 21 risk-based,xthe risks are really very low.
22' It does. interfere'in the patient-physician
- 23 interaction,Tand you're right, if'we as' physicians and 24 scientists.can come to an agreement, that sort of sets the 25J Llevelsof risk, but'then the public. perception and the s
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57 1l regulation and all the other things are something that, you 2-know, you have to make.the decision on as Commissioners.
3
.The ACMUI has'given you our' recommendation on it, and we're
'4
.awarefof all theLother things that need to be considered in 5
the rule-making'
)
)
6 CHAIRMAN DICUS:
Cathy, do you want to add 7:
.anything?
8 HANEY:
No, I think Lou really addressed MS.
9 everything.that we've heard so far.
~
10 CHAIRMAN ~DICUS:
Okay.
11-DR. WAGNER:
I'd like to make one comment'with 12 regard to that.
13 In the example that you.just gave, you're talking 11 4 about risks' associated with the general public for which J15
.they are'not seeking any. benefit.
16 Here we're talking about patients who;are sick.
~
17=
It's an entirely:different situation.
We're not talking l
-18 about chemical risks versus radiat. ion risks.
We're talking 19' about medical health' care for patients.
That's a totally 1
20
.different perspective, because we are going to intentionally
,1!
expose lthis; patient to radiation, j
2 22; That ~is not'something that was unintended.
It is 23-not:something that's accidental.
~24' It's'a' fact that.that patient came to us because i
25-Lthey'had a medical need and we-acted on that medical'need, 1
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and the: conceptus of that patient has a similar stake in the
'2 benefits _to the mother, and.every time we-irradiate a 3
patient,_weLalways have to take into consideration that they 4
may or may-not be_ pregnant, and we take that into full 5
consideration every time when we do the screening. properly.
6~
So, this is not the same kind of analogy,
~7 Chemical ~versus x-ray-versus others isn't the same.
We're 8
talking about risk-benefit.
That's what we always talk 9.
.about in medicine, and that's always what we have'to look L10 at, 'and in this caso, you're interfering with that 11
. risk-benefit relationship-between.the physician and his 12-patient or her patient.
13
' COMMISSIONER MERRIFIELD:
Well, I appreciate that
.14 comment; Again,~. I'would. argue, you're looking at it through 15
.the' lens of a very well; trained professional who understands 16 the risk.
17 What I'm trying to do is recognize that, relative 18 to untrained individuals in Congress and public policy _
19 individuals in Washington,'we've got to make decisions,'and 20 the general public, unfortunately, doesn't have the same 21 level of understanding on these issues that either.you or, 22
.to a lesser ex' tent, I have, and so, what we've got to do is 23 be reflective.of the individuals who don't have that level 24 of' understanding'and who have a higher sensitivity to the
' 25-
' areas in,which we regulate.
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11 DR.. WAGNER:
I think your stakeholders in terms of 2-members of.the' consumer rights advocates have given you some 3.
answers with regard to.that, and I think'you should listen 4'
to that.
)
5-CHAIRMAN DICUS:
I want to go back to pursuing the
'6 '
issue of reporting,'500 millirem to15 rem,-and part of the 7-basis,' as I understand it, for.-- and it's in,one of.your 8-
.back-up:clides from staff -- for a comfort level with-the
'9
.5-rem reporting -'- again, it is not a standard, it's not a 10-dose that's allowable, it's a reporting' requirement.-- is 11' based upon NCRP commentary number nine, I think, which 12 indicates that,1at 5-rem, there is not expected to be any 13 deterministic effects and perhaps-only a 1-percent.
14-stochastic effect to a fetus or conceptus at that rem.
15 Are you. comfortable -- and I'd ask this,.really, 16 of~both groups.-- are you comfortable _with'the criteria that 17 was-used to come up with that conclusion in NCRP commentary 21 8
.nine?
19' MS. HANEY:
From staff's standpoint, we.were 20 comfortable with that level, recognizing that there'is a j
21
. perceived. difference between these reporting levels and that 22 in Part 20, but because of these extenuating factors'that 23' Lou 1 mentioned and the impact'on' medical care, we' felt that 124 =
itLwas warranted.
25 DR.~ CERQUEIRA:
Lou', would you ' care to make a ANN RILEY & ASSOCIATES, LTD.
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comment on the selection of the level?
2 DR. WAGNER:
Well, one of the important factors 3
for the. selection of this level is the fact that that is 4-basically the level in medicine where if we have a situation 5
where a woman has been exposed to radiation and either we 6
find out that she's pregnant or we knew she was pregnant in 7
the first place or whatever, that level is the level where 8
we start considering the potential for medical intervention.
9 Below that level, there are no. recommendations for any 10 medical intervention other than discussing with the patient, 11 okay?
12 So, reporting in this level throws in -- reporting 13 below that level throws in a level of uncertainty that 14 erodes the patient-physician confidence again, by putting 15 that reporting level in lower than that, and that's what 16 we're trying to avoid here.
17 MS. McBURNEY:
As a health phy9icist, I'm 18 comfortable with the level of the 5-rem in accordance with 19 the recommendations in NCRP number nine as a reporting level 20 not as a dose limit.
21 CHAIRMAN DICUS:
Commissioner Merrifield.
22 COMMISSIONER MERRIFIELD:
I don't have any 23 additional questions.
24 CHAIRMAN DICUS:
Commissioner McG'ffigan.
-25 COMMISSIONER McGAFFIGAN:
Well, let me just follow ANN RILEY & ASSOCIATES, LTD.
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up on this'same line of questioning.
2
.The SR6 committee -- this may go to Ms. McBurney 3-as well as Mr. Wagner, but -- is basically saying that we 4
should be treating the embryo / fetus and nursing child as a 5
member-of the public, and their recommendation is 6
essentially going to'be that not to include anything here 7
but<to force you to treat these people elsewhere in the 8
model-state regulations as a member'of the public, so 100 9
millirem would be the limit, and I'm not advocating that at 10' all, but'I assume that your answer would be that that -- if 11 the SR6 view takes hold in any of the 31 agreement states, 12 that.that would be even more impacting on the practice of
'13 medicine, because you -- as I understand it, the medical 14 community believes that you treat-a-unit, you treat the 15 mother and child, the mother and embryo as a unit, and 16 you've just' articulated what the action levels are, but how
'17 Lis the SR6 view, which is so far afield from any of the 18 views'that we've irard here today, going to move forward, 19 and what is the -- how do stakeholders interact with the SR6 20-proces s, : I'mighc ask?
)
21.
You could answer the'first question.
I mean, you 22 know, I assume the answer is, if it was 100 millirems, there
~
23 would be even more of an impact.
)
"24 DR. WAGNER:
I'll be happy to address that issue.
i 25 I'll give!you an example.
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I 62
]
.J' fl A. woman comes'into the' emergency room.
She's been T2;
. in an automobile accident A :She's - a -young woman.
She might 3
- be' pregnant L LWe' don' t know.
She needs-immediate medical 4
care.
5
. We're going to order a CT scan,.because we lE
~~ consider'thatithere may be some injury to her pelvis.
We're
- going'to do:a'CT scan of the whole abdomen.
We need to have s7:
4 LB
-itidone; LWe;do-it. 'Okay.
Baby got about 4 rem from that 9
~ exam. 'She turned.out to be pregnant at'the time.
10-
'Now, if that'were a member of:the general public,
' 11' we'd have'to' report that' asian, overdose te a member of the 12 ;.
. general publiclfrom'that radiation.
. COMMISSIONER McGAFFIGAN:
Even though CT scans 13-
~14L aren't covered by-us, the state regulations would cover it.
11 5 DR. WAGNER:
Yeah.
.That's to give you the idea
'16; that.we'd have to. report it because it violates the member 17 of the'public being_ exposed to a 1evel like that.
~
18' Now, how absurd is that?
Clearly that baby is not
-19 ;
a member of.the general public.
L20:
Now,-you can-go_on down to any other situation 21
-that-you've.got.
L 2 2.-
.A woman presents herself in the doctor's office 23-cand'says I'm sick',aI'm feeling bad, here are my symptoms,
/24:
. etcetera.
257 The doctor works.up the patient and_ continues to ANN RILEY & ASSOCIATES, LTD.
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63 1
work the patient up and finally decides, well, we're going 2
to need this other study here, we're going to need this 3
nuclear medicine study, okay?
This is a sick patient.
4 If she is pregnant, that consideration is going to 5
have be taken into account by the doctor in what he 6
administers, what he prescriben, what he does, and the baby 7
is going to be part of that.
It's going to be in the baby's 8
interest that this mother is going to be around for the 9
baby.
It's going to be in the baby's interest that the 10 mother is healthy.
11 There is no way in the world anyone can argue that 12 this baby, who's going to be intentionally exposed to 13 radiation because the mother is sick, is rationally 14 considered a member of the general public and should be 15 restricted in terms of the dose that the baby is allowed *:o 16 receive.
17 We don't do that, and ri.,tfully so we don't do 18 that.
If we did that, we wouldn't be able to do any 19 diagnostic exams on young women or women of childbearing 20 potential.
21 COMMISSIONER McGAFFIGAN:
I'm very proud of the 22 process that we've gone through the last several years here, 23 with your involvement, with the wider public's involvement, 24 with massive public comments received and, I think, address 25 honorably and well.
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Tho SR6 process -- how does that work in the 2
states?
3 70 you get a model of regulation and do a five. day 4
notice and it's suddenly the rule, or how -- if the SR6 is, 5
as_ eloquently as Mr. Wagner is talking, making a major 6
mistake in its recommandation, how does that get resolved?
7-Is it a state-by-statv battle in 31 states?
8 MS. McBURNEY:
Yes, sir.
A short answer.
9 What the suggested state regulations provide is a 10 model that the states can use in their rule-making process,
.11 but each state has to undergo the same -- well, a similar 12 type of rule-making process that the Nuclear Regulatory 13 Commission does.
14 We have to publish notice of the rule.
In Texas, 15 what we would do is take the suggested state regulations and 16 the NRC regulations and pull from those, and there may be 17 instances where we may add or subtract, and then, looking at 18 the level of compatability, we take all those things into 19 account in our rule-making.
20 Then it would go out to the public for comment.
21 We have to address those comments the same way.
As a 22 regulator, we have to be sensitive, as Commissioner 23 Merrifield mentioned, to the perceptions of radiation risk 24 in our policy-making and the right tt know, and from a 25 regulatory standpoint, I feel that there snould be some ANN RILEY & ASSOCIATES, LTD.
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notification at-those medical event levels and that dose to
'2 the' embryo / fetus.
3-
,However, I do-recognize-that --
4 COMMISSIONER McGAFFIGAN:
At the 5-rem dose.
5 MS. McBURNEY:
Right, at 5.
j
- 6 In medicine, there is a unique physician-patient i
7-relationship, and'so, that'would be in the medical records.
j
}
8
.That's why I think maybe the alternative language route 9
might be an appropriate way to go.where you're talking about 10 the unique sit uation of a medical event, where it's not a q
- 11.
general member of.the public but in the unique situation --
12.
and that1could justify, then, the different. language that's 13 in Part 20.
14 MS. HANEY:
Two points is that, with the suggested 15
~ state regs, I believe 'some states are required to adopt them 16 verbatim by their legislation.
So, that's one thing that mas a suggested' state's'regs very important.
ke 17 18-The other is that I believe the next step from 19 where Dave is is'that'it does.go out to all the states for 20
- comment and for:their review, and.while it's not something 21 that's published in the Federal Register, it's something
]
22
_that Dave.would come.back and get based on the comments that 23;
- he receives from the state and possibly make some changes in i
24 the suggested state regs.
.25I MS. McBURNEY:
Yeah, that was the other point I ANN'RILEY & ASSOCIATES,.LTD.
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66 4
1-was goingito make,' is that-these suggested state:regs, in 2
draft form, have not-gone out to the_other states for peer 3'
freview, only;the: states that have'been involved or only the 4.
representatives involved on that' working' group-have actually
-5.
been involved.
j 6;
COMMISSIONER McGAFFIGAN:
In all honesty, I am 7
' sympathetic =to the' staff-proposal and what you're endorsing 8
in'this-area, in T&E, in whatever, and I believe that the 9
model state regulation as it exists at the moment clearly 10 impacts medical-practice in.a variety of areas more than
~
11
-what our staff is; proposing.
12
- Yet, I am worried about either'this. battleground' 13 in 21 states or some of the-31 having to, you know, just 14 automatically,-by.their legislation, adopt standards.
In 15 T&E, 1.see Georgetown here.
'I mean, you know, you're going
' 16.
- toitrain-somebody who's going to be able to practice in the 17 District and Virginia but not necessarily in Maryland, 18
. depending on if they decide'they're' going to do something 19 more.
20-Yet~, I think.there's a reluctance, given the 21-history of, you know,-we're a Federal system, as my 12 2 ~
-colleague 1from New' Hampshire is quite apt to point out, and
'23 I' fully acknowledge,.and the states have, in, whether it's 24T the practice of law or practice of medicine, they set the
-: 25 standards.
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67 1
So, there is a chance for 32 different outcomes, 2
Lyou know, for 19' states ours, and for 31 others quite 3
different outcomes on several of these issues.
4.
Yet, I hope that the states will give some real J
5 weight to the process that we went through, in the openness 6
and' transparency and whatever.
7 Does the medical community have a chance to
'8 involve itself in SR6?
l 9
DR. CERQUEIRA:
No, not really.
It.would have to 10-be at-the state level,'and Ild sort of like to endorse your 11 1 statements, as well, because this process has been very 12 open, you've really sought input, not just from the medical 13 community ut from the public.
14 Ju've taken, you know, four major meetings, and l'5 '
so, I think this rule is very'much -- has input from all of' 16-the'stakeholders, and as such, the state process, even does involve a certain amount of though it, you-know,.
~18' review, especially with T&E, it's going to make it very 19
' difficult,.and I think, right now, the NRC agreement state 20 concordances is category C.
21 I think, for training and experience, making it a 22 category B would really simplify the. effort on the training 23' fprograms and just physicians, because you really can't tell 24:
. where you're going to be practicing.
25 So, you could be practicing, authorized in one ANN RILEY & ASSOCIATES, LTD.
' Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C, 20036 (202) 842-0034 i
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p 68 11 state, either by training or experience or boards, and go to GL another statetand just not be able'to do it, and so, this 3
has been a very'well-developed, thought-out process with a 4-lot of; input, and I really.think'that, in some form, it 5-
-should be'more of a Federal overall policy, and they've had 6
three years in which.to review the recommendations and take 7
theirtown' actions.
8-So, we're not going to have an instant resolution 9
on the training and' experience.
10-COMMISSIONER McGAFFIGAN:
On patient release 11-
. criteria, as I understood-Mr.. Walter yesterday -- and I
'12 haven't seen his draft regulation, but he wasn't necessarily 113'
'against the 500-millirem patient release criterion, but he 14' was' stressing the. requirement for ALARA training, ALARA 15 training is' critical-in order to meet some of the concerns J16' that he saw,.but I think that was the thrust of hiss remarks 17 yesterday.
18 Is there any need for something to be in the rule
~
i 19 with regard.to ALARA training for the patient, you know, 20 adequate instruction?
Or is there already something in the
- 21~-
rule?
)
22 MS. HANEY:
There is a requirement in the rule
- 23 that', if you exceed 100-millirem, the authorized user needs 24.
Lto; provide the patient with: instructions, and it says 25
- explicitly instructions-on how'to minimize exposure.
So, i.
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that is going with the patient.
2 COMMISSIONER-McGAFFIGAN:
That goes with the 3
patient.
It goes with the loved ones of the patient, or the 4
nursing home, for that matter, who will receive the patient.
EF There's probably some written instructions that go with the 6
l patient.
7 HMS. HANEY:
Right.
The rule says that the 8
instructions would be provided to the patient.
9
'Now, I believe what Dave is trying to bring out 10 is, well, those instructions could get trashed on_the way
-11 home, there's no requirement for the patient to follow what 12 they're given, but even at~that, the idea is that, if the 13 instructions are'not followed, you're still not going to 14 exceed the 500 millirem.
15 COMMISSIONER McGAFFIGAN:
Right.
16; CHAIRMAN DICUS:
Commissioner Merrifield, 17 comments?-
'18 COMMISSIONER MERRIFIELD:
Yes, closing comments.
19 I do want to add my thanks to the other 20 Commissioners'.for this committee coming up and the amount 21 of time that you've spent in going over.these issues and 22 providing your input.
23 It is very helpful and useful and certainly will
$24-weighLin my determination about how to move forward on this
?25 rule.
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70 1-This.is;obviously?an area'where.I think we've all.
2.
spentiaLlot,of time:and effort in really trying to get 3
ourselves:uptto apeed so that we'can make an informed 4
decision-aboutc here we ought to go.
'5
.We-had an enormous number of comments on this
- 6; proposed rule,;over 500 pages of material put together to
- 7, Lanswerisome-ofnthosei I think is a recognition of the-time 8-
- we-spent in;considering those.
l9
.I think,, for'the vast' majority, those are very
'10 l thoughtful. comments,;and I think-the staff has attempted to-
- 11.
address'.those as. much as: possib1'e.
12'
-I;do have to note. since the time I'have been L
-13 here,:this has'been a rule-making which has had some 14 enormous personal-directed comments that I have seen.
~
- 15 I think it would be -- I don't think I can let.
16" slide - :some of the comments that were made, which, 17c frankly, coming.from members of the medical community, I
' 18,
felt were quite unprofessional, and personal attacks on this
.19 '
Commission, our: staff as well as the individual 202 Commissioners.
21t Unfortunately, that's the case.
That's why we 22 take these positions, and we are what.we are, but I was 23; disappointed by some members.of the medical community in the 724:
_ attacks that they made on us, in particular.
125 CHAIRMAN DICUS:
. Commissioner McGaffigan?
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71 1-COMMISSIONER McGAFFIGAN:
No further comment, 2
except'there's one member of the medical community, Carol 3
.Marcus, who'is, I think, the main person you have in mind 4-when'you make'that comment, and many of her comments are
'5' just1so.far off the mark that it's hard to read them.
'6 CHAIRMAN DICUS:
Anything else?
7
.I'm going to refrain from making any comments.
I 8
think-it's appropriate at the moment.
9 So, on behalf of my fellow Commissioners,'I would I
10 certainly'like to thank the staff from-the Division.of 11-Industrial and Medical Nuclear Safety and certainly members 11 2 of the Advisory Committee on the Medical Uses of Isotopes 13 for-thisivery informative briefing and for the good exchange
- 14 that1I'think we have'had.
15 It's very clear that all of you have worked 16 extremely hard over the past couple of years and-even beyond 17 that on this rule-making, and you've made greatEprogress in l
-18 addressing.the' numerous stakeholder concerns-with respect to 119-training land exp.erience requirementw, the reporting i
20 thresholds, which.we are still debating,'obviously, the 21 medicalievent notific'ation, and unintended, exposures, and 22 Trevised radiation safety committee requirements, while-
.23' taking into account, certainly, the implementation i
24 challenges that are going to face us as we put.this rule j
.25 into effect.
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L 72 1"
- Part of this ongoing interaction includes a new 2.
direction and' exchange of ideas for including more 3-performance-based,' risk-informed decision-making processes 4'
fin?our routine interactions with our stakeholders, as well 5.
as inclusion of these ideas into' revised regulations, since 6 '-
Lthe public's health and safety is paramount to all of our 17 endeavors.
8 I think we obviously share that in common.
9
'But we must take it upon ourselves to change the 10 old:way of developing regulatory strategies and instead use 11 our' technical competence, along with the insights drawn from 12-
.past operating history, to better' focus licensee and 13
. regulatory; attention'on design or operational issues
.14
. commensurate with their importance'to health and safety.
-15
'I believe it is paramount that the regulatory.
16 agencies ~in this country responsible for ensuring the 17) public's health and safety for medical.uses of ionizing
~18 radiation continue toLfocus all of our concerns on 19 higher-risk' activities to-ensure that any revisions in the 20 regulations,are technically sound and are risk-based.
21 If:we continue to work together in this manner, we 22 will: not only have-a solid materials regulatory program that
.23 provides reassurance to our stakeholders but a sound uniform 24-
' approach 11n! regulating the safe use if ionizing radiation
.25-for. medical' purposes.
l 1004 RILEY & ASSOCIATES, LTD.
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Do any of my fellow Commissioners have any other 2
closing. comments?
3
[No' response.]-
4-CHAIRMAN DICUS:
Therefore, we stand adjourned.
5-Thank you very much.
6-
- [Whereupon, at 11
- 12 a.m.,
the briefing was 7
. concluded.]
8 9
10 11-i 12'
-13 l
14-
)
- 15.
i 16 17 18.
.19-20
-21 i
22 i
' 2 3' 24 25 i
. ANN RILE'Y~& ASSOCIATES, LTD.
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F
.-e?
e 1
i CERTIFICATE
!This isLto' certify.'that the attached. description of a meeting
{
of-the:U.S.; Nuclear Regulatory Commission' entitled:
TITLE OF MEETING:
BRIEFING ON~PART 35 RULE ON MEDICAL'USE OF d
BYPRODUCT MATERIr4L i
PLACE OFEMEETING:
Rockville, Maryland DATE OF MEETING:
~ Thursday, October 21, 1999
]
1 was1 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-t'pewriting by me or under.the dire tion of the court y
. reporting company Transcriber:_Iamara Shion Reporter:
Mark Mahonev j
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