Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
1
1 UNITED STATES OF AMERICA
2 NUCLEAR REGULATORY COMMISSION
3 OFFICE OF THE SECRETARY
4 ***
5 BRIEFING ON PART 35
6 RULE ON MEDICAL USE OF BYPRODUCT MATERIAL
7
8
9 Room 1F-16
10 One White Flint North
11 11555 Rockville Pike
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., Greta J. Dicus, Chairman, presiding.
17 COMMISSIONER'S PRESENT:
18 GRETA J. DICUS, Chairman of the Commission
19 NILS J. DIAZ, Commissioner (Via Speaker Phone)
20 EDWARD McGAFFIGAN, JR., Commissioner
21 JEFFREY S. MERRIFIELD, Commissioner
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23
24
25
2
1 P R O C E E D I N G S
2 [9:36 a.m.]
3 CHAIRMAN DICUS: Good morning again, ladies and
4 gentlemen.
5 On behalf of my fellow 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
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 CFR 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 to listen and work with our stakeholders to modify
15 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
20 event.
21 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 communicate and work together to develop a draft
25 final rule that is both risk-informed and performance-based,
3
1 which is a vast improvement over the existing 10 CFR Part
2 35.
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
24 Directors were directly involved with the preparation and
25 development of the proposed and draft final rules.
4
1 While the information presented today is quite
2 extensive, we 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.
6 In other words, the staff present first and then
7 we will have a period of questions, and then the advisory
8 committee to present, with a series of questions, and if
9 time allows, we might have everybody at the table toward the
10 end.
11 If there are additional questions, as I mentioned,
12 we will try to have everyone together at the end.
13 Do any of my fellow Commissioners have any opening
14 remarks they wish to express?
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
21 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 a vast improvement over the previous Part 35, and I
25 compliment the staff for the effort.
5
1 CHAIRMAN DICUS: I thank you for those comments.
2 Commissioner Merrifield?
3 COMMISSIONER MERRIFIELD: I'd like to join in that
4 sentiment.
5 Cathy Haney, Diane Flack, and the rest of the Part
6 35 team have done an outstanding job. I know there are some
7 areas where some stakeholders still have concerns. We'll
8 work through those, but overall, it's a tremendous amount of
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 books, 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
17 you would introduce the staff, and we will get started.
18 DR. PAPERIELLO: Thank you, Madam Chairman and
19 Commissioners.
20 As you noted, the purpose of the meeting today is
21 to brief the Commission on the revision of Part 35, medical
22 use 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
25 the draft final rule before the Commission is the
6
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 direction 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
7
1 issues in the draft final rule, as well as the public
2 comments on the proposed rule and the comparison of current
3 requirements in Part 35 with the requirements in the draft
4 final rule.
5 Members of the Commission's ACMUI will follow
6 their comments -- with their comments on the staff's
7 proposed resolutions of the key issues.
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 Director of the Office of Nuclear Material Safety and
12 Safeguards; Dr. Donald Cool, Director of the Division of
13 Industrial, Medical, and Nuclear Safety; and Cathy Haney,
14 Chairperson of the Part 35 Working Group.
15 Ms. Haney will be presenting the staff's position
16 on the key issues.
17 Following the staff's presentation, Dr. Manuel
18 Cerqueira, Ms. Nekita Hobson, Ms. Ruth McBurney, and Dr.
19 Louis Wagner will present the ACMUI's position on the key
20 issues.
21 Cathy Haney will now 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
25 like to first go through what I would like to discuss with
8
1 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 resources 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 able 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
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1 SECY 99-201 was to provide the draft final rule language to
2 you, but we also used this as a mechanism for closing out
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 other thing 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
11 Control Program Directors that is developing a suggested
12 state regulation for the medical area.
13 In view-graph four, there are several issues that
14 we would like to highlight for the Commission's decision.
15 They are noted on this slide.
16 There are numerous other issues associated with
17 this project, but knowing that I couldn't have you for eight
18 hours to talk to you about them, we identified just the key
19 ones that we wanted to put before you, the first one being
20 --
21 CHAIRMAN DICUS: Do you think you can get all the
22 key issues just in eight hours?
23 MS. HANEY: No.
24 COMMISSIONER MERRIFIELD: That's reading them.
25 MS. HANEY: It's not telling you the background.
10
1 COMMISSIONER McGAFFIGAN: Madam Chairman, I just
2 might note -- I forget whether we've said it already. This
3 paper has been available to the public since early August,
4 and we've been pouring over it and getting briefed on it bit
5 by bit.
6 So, this is the tip of the iceberg of the
7 Commission's involvement in this paper and, I think, the
8 public involvement, as well.
9 COMMISSIONER MERRIFIELD: I'd actually, just for a
10 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 from the staff on 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.
23 MS. HANEY: Thank you.
24 All right.
25 The first topic would be the need for a risk
11
1 assessment, and the issue here is whether we need to perform
2 a formal risk assessment.
3 After the March briefing, the Commission asked 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
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.
12
1 Just to give you an example of a few of them for
2 consideration would be as the reduction in the radiation
3 safety committee, 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 on Part 20 as the governing regulation, as compared
8 to Part 35, and also, we've made some changes in the
9 requirements for what 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 the 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
22 medical physicist, radiation safety officer, they believe a
23 very strong importance for the safety committee, where
24 others believed that it was more important to have
25 flexibility.
13
1 Our recommendation would be that the radiation
2 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
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 to be in your oncology department. If you had a
16 gamma stereotactic radiosurgery unit, that tends to be in
17 your neurosurgery units.
18 The concept of -- the need for a radiation safety
19 committee is to bring departments together so that they can
20 speak, and that's why we believe that this was important
21 here.
22 We also believe this is a very good example of
23 where we considered risk in reducing requirements.
24 Next view-graph, seven, has to do with training
25 and experience requirements, and this was probably the
14
1 biggest issue that we had to address under this particular
2 rule-making. It also received the most comments.
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
25 on the preceptor form.
15
1 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 hours of
8 training, total, and we specify in the rule what we would
9 want the individual to know.
10 So, 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 hours be increased to that required for radiation oncology.
19 However, we were concerned about the impact on the
20 profession by doing this.
21 We were also aware that there were a significant
22 number of misadministrations in this particular area, but we
23 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.
16
1 The cause of the misadministrations were sources
2 that had not been calibrated properly and had not been
3 decayed.
4 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.
8 Again, we recognize it is a prescriptive
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 been 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
17
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
4 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.
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
12 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
16 would be paying for this, whether it would be covered for
17 insurance or not. Would the patient be able to go to the
18 same 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
23 report to NRC -- and therefore order tests that would not be
24 as good as the nuclear medicine test as a diagnostic tool.
25 We consider this in light of the risks associated
18
1 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 Lou 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
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
25 physician, or the authorized user to notify either the
19
1 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 particular area, and that was
14 in response to the SRM that we received after 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
23 report was given; it's merely licensee certify to us that
24 you told them.
25 From the pros associated with this alternative, we
20
1 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 patient -- with other Federal patient
6 notification requirements, that being FDA's, and then it
7 also -- one could argue that it is stepping more into a more
8 risk-informed situation 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 one.
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 excess of the limits.
18 So, as I said, we have -- the draft final rule
19 text has the current requirements in it, but you do have the
20 alternative text, if you would like to consider that.
21 There are two additional concerns raised by the
22 SR6 committee.
23 One has to do with criteria for releasing
24 individuals, slide 14, and that being that there are two
25 cases where -- two items that they would suggest going into
21
1 the suggested state regulations.
2 Under this particular item, the states would have
3 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
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 with 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.
17 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
20 of their treatment. Therefore, we see no reason to preclude
21 that.
22 However, the SR6 committee would so require a
23 private room.
24 The other is that they would like to see some
25 additional survey requirements in their equivalent to Part
22
1 35, where we feel confident that the licensee's radiation
2 safety program under Part 20 would adequately address this.
3 View-graph 15 covers real briefly the implications
4 in the licensing inspection and enforcement program.
5 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
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.
4 Our plan is not to go into reviewing these
5 procedures at all, really, during 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
16 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 be it, because there are -- any changes in the
21 overall enforcement policy are being handled under a
22 separate effort.
23 View-graph number 16 addresses the resources and
24 time-table for completion of the rule. My best guess is
25 that it will take approximately three FTE to complete the
24
1 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 OMB 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.
25
1 The first one is on slide seven, and it's the last
2 sub-bullet, where it says NRC recognition, especially
3 boards, and I simply want to point out we are talking about
4 recognizing, not approving.
5 MS. HANEY: Correct.
6 CHAIRMAN 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 hours of required training for the use of I-131. Would you
24 please explain why 80 hours of training" -- and I realize
25 you may have already done this, but I think, for the record,
26
1 for him -- "is sufficient for the safe administration of
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, in "In your
6 discussion, would you please address health and safety
7 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 hours 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 were specific to the endocrinologist. So, we had
19 recommended an increase.
20 We did have a lot of interactions with the
21 endocrinology community, where 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 whether an increase in this particular area was
27
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
4 could be attributed to an endocrinologist as compared to
5 another type of user, and really, what we've been hearing is
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 made in
19 this area was the greater reliance on the preceptor.
20 Whether you're looking at someone preceptoring for
21 use of I-131 or for a remote after-loader or a radiation
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
28
1 actually saying the individual took the training, but in his
2 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 leave the training requirements at the same level as they
6 are right 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 these 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
20 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, if they do go wrong, they know how to handle it, also
24 recognizing that there are certain -- it's almost a -- well,
25 it is a specialty, that they're only using iodine, majority
29
1 is only used in capsule form and, therefore, cutting down on
2 the problems with potential contamination, and you're only
3 dealing with one organ, and based on all of that, I think
4 it's just a separate category for this particular type of
5 user is warranted.
6 With regards to the question about did we consider
7 the health and safety associated with use of the workers and
8 the public -- and I'm going to assume this is specific to
9 iodine -- yes, we did, and I believe that the regulations
10 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,
13 and it is -- and the release is based on the dose to the
14 maximally exposed individual.
15 So, from that standpoint, I think that that
16 addresses one set of populations, really your public
17 exposures.
18 Part 20 would address your occupational exposures,
19 and again, the licensee still needs to comply with Part 20,
20 so all of those requirements are still in place.
21 So, because of, you know, the combination of Part
22 35 and 25, I think that the public health and safety, as
23 well as occupational health and safety, is protected by the
24 draft final rule.
25 CHAIRMAN DICUS: Okay. Thank you for your
30
1 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 submitted 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
31
1 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, it gives the licensees maximum flexibility
8 in those areas where we think, because of the risk, that
9 it's warranted.
10 Any procedure that we've reviewed, they're tied to
11 in their license. So, they cannot change 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 eliminates that need.
15 So, it has to do with flexibility for the
16 licensee, but yet, at the same time, I don't think we're
17 reducing any of the safety considerations.
18 COMMISSIONER McGAFFIGAN: I would think that OMB,
19 when it did the paperwork reduction review --
20 MS. HANEY: They'll like us.
21 COMMISSIONER McGAFFIGAN: They'll like you on this
22 particular item.
23 Authorized user duties was a slide he had
24 yesterday, and he claimed there's a Catch-22 because there
25 are no duties specified in Part 35 for the authorized user
32
1 unless a written directive is required.
2 It sounds like a technical point that he was
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 employee, 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,
33
1 which he cited in his view-graph, is really needed to make
2 sure that NRC -- that the licensee is clear that they'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 I 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?
16 MS. HANEY: The working group considered having
17 training and experience requirements for technologists back
18 in late '97, on 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
22 if we put a requirement for the training and experience in
23 our rule and it was only focused on radiation safety, that
24 we might actually be negatively impacting the medical
25 practice, the handling of it, because licensees are always
34
1 going to be looking for ways of saving money, and if our
2 rule says you only need 100 hours 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 hours 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
22 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.
35
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 performing a full-blown risk
8 assessment.
9 I was wondering if you could perhaps expand a
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 Our estimate is that, in order to do a formal risk
18 assessment and to carry that into regulations could take
19 approximately 10 FTE to do, and we're looking at five years
20 to complete that project, again, we're looking at a very
21 thorough assessment here. It also could take several
22 million dollars to do that.
23 Our concern is that this rule does provide
24 immediate relief to some of the diagnostic users, and if we
25 were to wait and hold this rule to complete that, we
36
1 actually are 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 comments 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. HANEY: 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
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
5 hear, during the process, at the public meetings -- we had
6 two patients rights advocates come, and they did not believe
7 there should be an NRC requirement for this type of -- for
8 the notification.
9 Their view was this was between the patient and
10 the physician and it was just not needed to have the NRC
11 step in, but they were, you know, two people sitting at the
12 table.
13 COMMISSIONER MERRIFIELD: I'm reminded of
14 experience 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.
20 Whether the greater patient community was aware of
21 what we were doing or not remains to be seen. I leave that
22 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 mention, related to the
38
1 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 millirem 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
39
1 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,
15 harmonize in terms of the rule-making notice and the
16 Commission's ultimate adoption of the alternative, would
17 want to harmonize it with other notification requirements
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
40
1 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
41
1 demonstrated, was to just go through our presentation.
2 You'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.
5 If we could have the briefing outline, we will
6 make some general comments, we will then deal with the
7 radiation safety committee, the training and experience
8 issue, 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 to the patients.
17 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
22 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 that the draft rule is
42
1 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 is appropriately
24 provided at the various facilities.
25 Slide four.
43
1 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 to 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
24 taken traditional programs but who have gotten the
25 appropriate clinical and radiation safety experience to
44
1 become authorized users.
2 There was some concerns expressed by the committee
3 in terms of national standards 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
11 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 with regards to training
16 and experience, would be very important, especially for the
17 people that are coming in through the alternative pathway,
18 through the experience requirements without the boards, that
19 by just allowing the NRC states to have these new
20 modifications, people involved in training programs are
21 going to be very much stretched in order to provide training
22 that will allow people to practice wherever they have the
23 opportunity to do so.
24 We also feel that -- and this was an issue that
25 came up several times in terms of emerging technologies.
45
1 Intravascular brachytherapy for prevention of restonosis was
2 one thing that came up, 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 35.1000, 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
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 to the NRC unless
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
46
1 deal -- there were specific questions related to this.
2 It's the feeling of the committee that the risks
3 are really very low and that the 5-rem reporting limit is
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 and 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
47
1 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,
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,
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
19 public, the users, or the patients, really need to be
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
25 some models, especially those less sophisticated sites.
48
1 This will give them some informed basis upon which to send
2 their applications.
3 We believe, also, that implementation of the rule
4 will continue to require some -- 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 So, this really concludes our presentation in
11 terms of the recommendations of 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 have the new requirements in place within six
20 months of the rule becoming final, and I guess my question
21 is, is six 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?
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 boards that are going to apply, and I think as Cathy pointed
8 out in her overhead, with enough FTEs, we should be able to
9 get this done.
10 I think the interested boards have already met
11 with the NRC, and they have actually initiated within their
12 own organizations steps for applying.
13 So, I think 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
16 would be adequate time.
17 CHAIRMAN DICUS: Okay.
18 Cathy?
19 MS. HANEY: Six months is adequate time for the
20 licensees to adopt the new regulation, recognizing that the
21 majority of what's in the rule is actually a reduction. So,
22 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
24 start over from scratch in developing new procedures.
25 I would say that the one key, though, is the early
50
1 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 we 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
51
1 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
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
15 my understanding that, if there is a report to the NRC,
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
23 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.
52
1 Then patient's going to get this report and say,
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 regard to the patient-physician
7 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's pregnant, patient comes back later and says, oh, I
16 happened to 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
19 to now I've got to report this to the NRC. Well, maybe I
20 don't want to report that to the NRC. Maybe what I ought to
21 do is just not do these examinations.
22 That will have an influence. It will change the
23 way people practice medicine. So, there is a difficulty
24 with regard to that.
25 Furthermore, what is going to happen with regard
53
1 to pregnancy testing? Are we going to require more and more
2 pregnancy testing for women when they come in because they
3 might be pregnant?
4 We might catch a few more, but pregnancy testing
5 in itself is not foolproof and we still might not be able to
6 catch all of them. What are we going to do now? Instigate
7 a 10-day rule?
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.
12 We find out later on, after we delay to find out
13 if she is pregnant, that indeed she is pregnant. Then we
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
18 to have an impact on medical care as we currently practice
19 it.
20 Now, if we look 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 those kinds of changes on medicine, and I think that we have
25 to come to an agreement on a reporting mechanism that
54
1 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
55
1 of care for medical practice, and to have it regulated like
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 those facilities than the reactors that we regulate, and we
25 get the same complaint from our reactor operators, gee, you
56
1 have all these security requirements on us, and I got a
2 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,
4 and the reason it's true is because there is a much greater
5 public sensitivity to the areas in which you practice and we
6 regulate than there is with chemicals, and I think that's a
7 fact of 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 the regulated community as well as the regulators that
12 affect the manner in which we have to go.
13 CHAIRMAN DICUS: Cathy -- oh, do you want to
14 respond?
15 DR. CERQUEIRA: 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
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, the risks are really very low.
22 It does interfere in the patient-physician
23 interaction, and you're right, if we as physicians and
24 scientists can come to an agreement, that sort of sets the
25 level of risk, but then the public perception and the
57
1 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 aware of all the other things that need to be considered in
5 the rule-making.
6 CHAIRMAN DICUS: Cathy, do you want to add
7 anything?
8 MS. HANEY: No, I think Lou really addressed
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
14 about risks associated with the general public for which
15 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
18 about chemical risks versus radiation risks. We're talking
19 about medical health care for patients. That's a totally
20 different perspective, because we are going to intentionally
21 expose this patient to radiation.
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
25 they had a medical need and we acted on that medical need,
58
1 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, we always 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
10 at, and in this case, 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 extent, 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.
59
1 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 to 5 rem, and part of the
7 basis, as I understand it, for -- and it's in one of your
8 back-up slides 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, at 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
18 nine?
19 MS. HANEY: From staff's standpoint, we were
20 comfortable with that level, recognizing that there is a
21 perceived difference between these reporting levels and that
22 in Part 20, but because of these extenuating factors that
23 Lou mentioned and the impact on medical care, we felt that
24 it was warranted.
25 DR. CERQUEIRA: Lou, would you care to make a
60
1 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 physicist, 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 McGaffigan.
25 COMMISSIONER McGAFFIGAN: Well, let me just follow
61
1 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 is the SR6 view, which is so far afield from any of the
18 views that we've heard here today, going to move forward,
19 and what is the -- how do stakeholders interact with the SR6
20 process, I might 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.
25 I'll give you an example.
62
1 A woman comes into the emergency room. She's been
2 in an automobile accident. She's a young woman. She might
3 be pregnant. We don't know. She needs immediate medical
4 care.
5 We're going to order a CT scan, because we
6 consider that there may be some injury to her pelvis. We're
7 going to do a CT scan of the whole abdomen. We need to have
8 it done. We 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 as an overdose to a member of the
12 general public from that radiation.
13 COMMISSIONER McGAFFIGAN: Even though CT scans
14 aren't covered by us, the state regulations would cover it.
15 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 level like that.
18 Now, how absurd is that? Clearly that baby is not
19 a member of the general public.
20 Now, you can go on down to any other situation
21 that you've got.
22 A woman presents herself in the doctor's office
23 and says I'm sick, I'm feeling bad, here are my symptoms,
24 etcetera.
25 The doctor works up the patient and continues to
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 prescribes, 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 to
16 receive.
17 We don't do that, and rightfully 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.
64
1 The SR6 process -- how does that work in the
2 states?
3 Do 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 recommendation, how does that get resolved?
7 Is it a state-by-state 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 to know, and from a
25 regulatory standpoint, I feel that there should be some
65
1 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.
6 In medicine, there is a unique physician-patient
7 relationship, and so, that would be in the medical records.
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 situation of a medical event, where it's not a
11 general member of the public but in the unique situation --
12 and that could 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
17 makes a suggested state's regs very important.
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
24 the suggested state regs.
25 MS. McBURNEY: Yeah, that was the other point I
66
1 was going to make, is that these suggested state regs, in
2 draft form, have not gone out to the other states for peer
3 review, only the states that have been involved or only the
4 representatives involved on that working group have actually
5 been involved.
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 31 states or some of the 31 having to, you know, just
14 automatically, by their legislation, adopt standards. In
15 T&E;, I see Georgetown here. I mean, you know, you're going
16 to train 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
22 colleague from New Hampshire is quite apt to point out, and
23 I fully acknowledge, and the states have, in, whether it's
24 the practice of law or practice of medicine, they set the
25 standards.
67
1 So, there is a chance for 32 different outcomes,
2 you 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
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?
9 DR. CERQUEIRA: No, not really. It would have to
10 be at the state level, and I'd sort of like to endorse your
11 statements, as well, because this process has been very
12 open, you've really sought input, not just from the medical
13 community but from the public.
14 You've taken, you know, four major meetings, and
15 so, I think this rule is very much -- has input from all of
16 the stakeholders, and as such, the state process, even
17 though it, you know, does involve a certain amount of
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 programs 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
68
1 state, either by training or experience or boards, and go to
2 another state and 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 their own 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
13 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
16 that he saw, but I think that was the thrust of his remarks
17 yesterday.
18 Is there any need for something to be in the rule
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 to provide the patient with instructions, and it says
25 explicitly instructions on how to minimize exposure. So,
69
1 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.
5 There's probably some written instructions that go with the
6 patient.
7 MS. 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 weigh in my determination about how to move forward on this
25 rule.
70
1 This is obviously an area where I think we've all
2 spent a lot of time and effort in really trying to get
3 ourselves up to speed so that we can make an informed
4 decision about where 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 answer some of those, I think is a recognition of the time
8 we spent in considering those.
9 I think, for the vast majority, those are very
10 thoughtful comments, and I think the staff has attempted to
11 address those as much as possible.
12 I do have to note, since the time I have been
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,
17 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
20 Commissioners.
21 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
24 attacks that they made on us, in particular.
25 CHAIRMAN DICUS: Commissioner McGaffigan?
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 just so 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
10 certainly like to thank the staff from the Division of
11 Industrial and Medical Nuclear Safety and certainly members
12 of the Advisory Committee on the Medical Uses of Isotopes
13 for this very informative briefing and for the good exchange
14 that I 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 great progress in
18 addressing the numerous stakeholder concerns with respect to
19 training and experience requirements, the reporting
20 thresholds, which we are still debating, obviously, the
21 medical event notification, and unintended exposures, and
22 revised radiation safety committee requirements, while
23 taking into account, certainly, the implementation
24 challenges that are going to face us as we put this rule
25 into effect.
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 in our routine interactions with our stakeholders, as well
5 as inclusion of these ideas into revised regulations, since
6 the public's health and safety is paramount to all of our
7 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 to focus 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 in regulating the safe use if ionizing radiation
25 for medical purposes.
73
1 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.]
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