1 

UNITED STATES OF AMERICA 

NUCLEAR REGULATORY COMMISSION 

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MEETING WITH THE ADVISORY COMMITTEE ON THE MEDICAL 

USES OF ISOTOPES 

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THURSDAY, 

MARCH 17, 2016 

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ROCKVILLE, MARYLAND 

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The Commission met in the Commissioners' Hearing 

Room at the Nuclear Regulatory Commission, One White Flint North, 

11555 Rockville Pike, at 9:30 a.m., Stephen G. Burns, Chairman, 

presiding. 

COMMISSION MEMBERS: 

STEPHEN G. BURNS, Chairman 

KRISTINE L. SVINICKI, Commissioner 

WILLIAM C. OSTENDORFF, Commissioner 

JEFF BARAN, Commissioner 

ALSO PRESENT: 

ANNETTE L. VIETTI-COOK, Secretary of the Commission 

MARGARET M. DOANE, General Counsel 
 2 

ACMUI PANEL: 

PHILIP O. ALDERSON, M.D., ACMUI Chair 

STEVEN R. MATTMULLER, ACMUI Nuclear Pharmacist 

CHRISTOPHER J. PALESTRO, M.D., ACMUI Nuclear 

Medicine Physician 

LAURA M. WEIL, ACMUI Patients' Rights Advocate 

PAT B. ZANZONICO, Ph.D., ACMUI Vice Chair 
 3 

1 P R O C E E D I N G S 

2 9:30 a.m. 

3 CHAIRMAN BURNS: Good morning, everyone. I 

4 want to welcome you to our meeting today with our Advisory Committee 

5 on the Medical Uses of Isotopes. I welcome the members here today. 

6 The Commission will be holding a meeting in order to 

7 hear views of the Committee members to provide on significant issues 

8 that have come before them. 

9 Before we being, on behalf of the Commission, I would 

10 like to take this opportunity to congratulate Dr. Philip Alderson for being 

11 appointed as Chairman of the Advisory Committee and Dr. Pat 

12 Zanzonico for being appointed as Vice Chairman of the Committee in 

13 October of 2015. Dr. Alderson has served on the Committee since 

14 2014, and Dr. Zanzonico has been on the Committee since 2010. We 

15 are very fortunate to have you serve in these roles, and we appreciate 

16 it. 

17 Today we will be briefed by several members of the 

18 Committee on various topics, including an overview of activities of the 

19 Advisory Committee. We will hear, also, comments on the NRC's 

20 Patient Release Project. Ms. Weil, the Patients' Rights Advocate, will 

21 provide comments on that project. 

22 Other members who are here, Dr. Palestro, a nuclear 

23 medicine physician on the Committee, will discuss the Committee's 

24 comments on training and experience requirements for authorized 

25 users of alpha and beta emitters. And Mr. Steven Mattmuller, a 

26 nuclear pharmacist member on the Committee, will discuss 
 4 

1 decommissioning funding plan requirements for the medical use of 

2 germanium-68/gallium-68 generators. I think Chairman Alderson is 

3 also going to provide some comments on enhancing communications. 

4 After the presentations, we will have a 

5 question-and-answer period with the Commission. Before I begin, any 

6 of my colleagues have any comments? 

7 (No response.) 

8 All right. Then, I will turn it over to you, Dr. Alderson. 

9 DR. ALDERSON: Thank you. 

10 Good morning, and thank you, Chairman Burns and 

11 the Commissioners, for meeting with us today. 

12 My name is Dr. Phil Alderson, and I am the ACMUI 

13 Chairman. Today I will give you an overview of the ACMUI's purpose, 

14 of activities that the Committee has performed since the last 

15 Commission meeting, as well as continuing current activities. 

16 The next slide, please. 

17 The ACMUI exists to advise the NRC staff, and, thus, 

18 you, the Commission, on the policy for medical uses of radionuclides 

19 and, also, to provide technical assistance and to serve as consultants. 

20 There are 13 physicians -- next slide, please -- on the 

21 ACMUI, six physicians, two physicists, one radiation safety officer, one 

22 patients' rights advocate, and two governmental representatives. 

23 Next slide, please. 

24 Some topics addressed by the ACMUI in the last year 

25 include refining some aspects of 10 CFR Part 35 rulemaking, including 

26 NUREG-1556, Volume 9; revising the NRC's Abnormal Occurrence 
 5 

1 Criteria as the criteria relate to medical events; medical events 

2 themselves for all medical applications, with particular attention -- next 

3 slide, please -- to those involving yttrium-90-labeled microspheres; the 

4 training and experience requirements for 10 CFR 35.390 AUs, 

5 Authorized Users, of alpha and beta emitters. 

6 Next slide, please. 

7 Revisions to the NRC's Radioactive Seed Localization 

8 Licensing Guidance and the decommissioning funding plan 

9 requirements for the medical uses of germanium-68/gallium-68 

10 generators. 

11 Next slide, please. 

12 A clarification of the term "patient intervention" and 

13 review and consideration of three petitions for rulemaking related to the 

14 LNT Model and standards for protection against radiation. 

15 Next slide, please. 

16 The current ACMUI topics include continuing 

17 discussions that involve patient release, review of medical events, 

18 medical event reporting for all modalities, and training and experience 

19 requirements for Authorized Users of alpha and beta emitters. 

20 Next slide, please. 

21 Additional continuing topics include Radioactive Seed 

22 Localization Licensing Guidance; addressing the decommissioning 

23 funding plan requirements for the medical use of 

24 germanium-68/gallium-68 generators; the Leksell Gamma Knife Icon 

25 Licensing Guidance. 

26 Next slide, please. 
 6 

1 And ways to enhance communications between the 

2 NRC staff, the ACMUI, and the medical community. 

3 Next slide, please. 

4 The ACMUI currently has a number of issues under 

5 discussion. As new issues arise, including emerging technologies, we 

6 will address and provide advice on aspects relevant to the safe 

7 handling of radioactive sources. 

8 At this time, I would like to turn to Vice Chair Pat 

9 Zanzonico to begin more focused discussions. 

10 DR. ZANZONICO: Thank you, Dr. Alderson, and 

11 thank you, Commission, for the opportunity to present. 

12 Could I have the first slide, please? 

13 I would like to emphasize that these comments do not 

14 necessarily reflect a unanimous, or even necessarily majority, opinion 

15 of the ACMUI on the NRC's ongoing Patient Release Project. Further, 

16 the ACMUI has not yet had the opportunity to review the work to date by 

17 the NRC staff on that project. So, this is some tentative or to-date 

18 comments on this project. 

19 The next slide, please. 

20 I first wanted to take the opportunity, as long as we had 

21 it, to re-endorse the use of radiation dose- versus activity-based release 

22 criteria for radionuclide therapy patients. It is important to emphasize 

23 this is strictly within the context of radionuclide therapy and not 

24 necessarily other contexts. 

25 Needless to say, the health benefits of radionuclides in 

26 general and radionuclide therapy, in particular, are widely recognized 
 7 

1 and established. Although there is some difference of opinion, in my 

2 opinion, certainly, the doses to the public which we are discussing are 

3 really of the order of background doses. And so, given these 

4 considerations, I think that there is unanimity of opinion that excessive 

5 regulatory control on radionuclide therapy and related issues should be 

6 avoided. 

7 Next slide, please. 

8 Further, and by way of a prologue, radiation dose is 

9 certainly a more meaningful and direct metric of radiation risk than is 

10 activity. It has been demonstrated in a number of ways the amount of 

11 radioactivity or the activity in a radionuclide therapy patient really is not 

12 a reliable predictor or indicator of radiation dose to other individuals 

13 from a radionuclide-therapy-treated patient. 

14 Next slide, please. 

15 So, again, we would like to take this opportunity to 

16 re-endorse the current regulation which promulgates a dose-based 

17 rather than activity-based release criterion for radionuclide therapy 

18 patients. The ACMUI remains convinced that that is certainly the more 

19 appropriate, the more scientifically-sound approach to formulating 

20 release criteria. 

21 Next slide, please. 

22 So, again, the NRC, through its Patient Release 

23 Project, is developing at patient-directed website and related 

24 documentation, specifically, a brochure providing information on 

25 radionuclide therapy, and specifically, iodine-131 sodium iodide 

26 treatment for thyroid diseases related to patient release and other 
 8 

1 patient safety issues. 

2 Now this is an ongoing project. As I said initially, the 

3 ACMUI has not yet had the opportunity to see the work product to date. 

4 So, this is not specifically a commentary on that work to date, but more 

5 on the general concept, the general principle of an NRC website and 

6 related materials. 

7 Next slide, please. 

8 What I would like to emphasize is that there is wide 

9 variability in the quantity and quality of radiation safety and related 

10 information conveyed from physicians, treating physicians, to their 

11 patients. There is no disputing that. As I said, there is wide variability 

12 in quality and quantity. 

13 Now some of this variability is legitimate in the sense 

14 that it reflects differences among patients in terms of their treatments 

15 and in terms of their living in other circumstances. But certainly there 

16 is a component that is just simply due to a lack of a systematic 

17 dissemination of such information from physicians to patients. 

18 Next slide, please. 

19 So, given that, there certainly is a pressing need for 

20 formulation and dissemination of systematic data that is clear, 

21 consistent, and scientifically-based related to radiation safety 

22 information that is conveyed to patients. At least myself and a number 

23 of other members of the ACMUI, though not all of them, feel that there is 

24 already adequate such information in the peer-reviewed medical 

25 literature and that the issue is not one of regulation, but, rather, of 

26 professional education. 
 9 

1 Next slide, please. 

2 Just as one example of this -- and in terms of full 

3 disclosure, I was a coauthor of this NCRP Report -- but NCRP Report 

4 No. 155, entitled "Management of Radionuclide Therapy Patients," 

5 dealt in-depth with issues of patient release, not only in the context of 

6 iodine-131 sodium iodide therapy, but for many other isotopes and 

7 many other therapeutic agents, dealt with the issues of patient release 

8 and related radiation safety issues, including post-release precautions, 

9 including disposal of household waste, which I should take the 

10 opportunity to say we certainly endorse that such waste should be 

11 handled in the general waste stream and certainly not sequestered or 

12 returned to the hospital or any such thing as that. 

13 That aside, among the features of this report is an 

14 Excel file which, based on some very simple and limited number of 

15 measured patient values and parameters, will yield a patient's specific 

16 time of release and duration of variation post-release precautions. 

17 This Excel file, then, populates a two-page patient-specific instruction 

18 sheet which can be given to the patient. We have distributed this 

19 Excel file and related documentation to already over 50 centers. 

20 For any of you who are familiar with the NCRP 

21 reporting process, they are very thoroughly and critically vetted by the 

22 scientific community. So, this is just one example of available 

23 resources to professionals that already deal, we feel, rigorously with 

24 this entire issue. 

25 Next slide, please. 

26 And so, the inadequacy and inconsistency in radiation 
 10 

1 safety information, to the extent it exists, is really a matter of 

2 professional education that at least some of us on the ACMUI feel is 

3 most appropriately and most effectively handled not through a 

4 regulatory agency, but, rather, through physician education in terms of, 

5 for example, professional societies' practice guidelines. 

6 Next slide, please. 

7 So, given that at least some of us feel that a 

8 patient-directed website and brochure, however well-intended and 

9 however rigorously vetted, is really inappropriate because it effectively 

10 interposes a regulator, in this instance the NRC, between the patient 

11 and his or her physician. To some extent, it could actually exacerbate 

12 confusion and anxiety among patients and to some extent among the 

13 general public in that it inevitably fails to account for patient-specific 

14 differences in living circumstances and other issues. 

15 Next slide, please. 

16 So, that concludes my comments. I would now like to 

17 introduce the ACMUI Patient Advocate, Ms. Laura Weil. 

18 MS. WEIL: Thank you, Dr. Zanzonico, and thank you 

19 for the opportunity to present some perspective on the Patient Release 

20 Project from the point of view of a patient advocate. 

21 I would like to make one comment on Dr. Zanzonico's 

22 presentation before I go into my own, which is his assertion that 

23 iodine-131 really won't result in public exposures above background. 

24 But I would like to make the point that, unless good patient release 

25 instructions are provided and understood by the patient, indeed, 

26 iodine-131 patients may expose the public to greater-than-background 
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1 levels of radiation. 

2 The Patient Release Project has some significant 

3 benefits as well as some potential shortcomings in its concepts. One 

4 of the major benefits is that it creates an opportunity for professional 

5 organizations, individual clinicians, and patients to review procedures 

6 for release of iodine-131 patients in the context of best clinical 

7 practices. 

8 It also creates a potential for reconciliation of 

9 discrepancies in the instructions patients receive for radiation 

10 protections for family and the public in the post-treatment period, and it 

11 creates opportunity for framing for patients how they can access 

12 additional information, advocate for themselves, and generally be 

13 knowledgeable about their care and how to protect the public. The 

14 website that is proposed is not specifically patient-directed, but, rather, 

15 directed to the entire community of clinicians and organizations and 

16 patients who are involved in iodine-131 therapy. 

17 The potential shortcomings include that the project 

18 may not address issues of access to information and instruction for 

19 patients with limited literacy or limited English proficiency. Given the 

20 passive collection aspect of the project which relies on the medical 

21 community and the public to submit material, the receipt of patient 

22 education information and materials in video or translated formats may 

23 be less than what is needed. In addition, passive data material 

24 collection may not elicit information from small sites that are not 

25 connected to academic sites or the professional organizational 

26 networks. 
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1 Iodine-131 therapy is delivered in a broad array of 

2 venues. Guidance that is appropriate for one kind of medical setting 

3 may not be completely relevant for another kind of setting. The 

4 logistics of delivering care in the community differ from the delivery in 

5 large tertiary care facilities. Resources vary. 

6 For example, not all patients may have access to a 

7 nuclear medicine physician. So, patient education materials that 

8 recommend making an appointment with a nuclear medicine physician 

9 may not be appropriate for all patients. Expectations created on the 

10 web portal for care in larger medical centers may not be realized in the 

11 non-hospital or community setting. 

12 The assertion that regulating the provision of 

13 information to patients on how to protect the public from radiation 

14 exposure after iodine-131 therapy is interfering in the practice of 

15 medicine is misguided, in my opinion. Regulating how patients are 

16 informed about protecting members of the public from radiation 

17 exposure is a matter of public health, well within the purview of 

18 regulation. 

19 The purpose of the Patient Release Project is to assist 

20 in the development of guidance for licensees and information for 

21 patients, but guidance without the teeth of regulation is intrinsically 

22 vague and disjointed and provides poor protection for the public. 

23 Thank you. 

24 I will turn the microphone over to Dr. Palestro. 

25 DR. PALESTRO: Thank you. 

26 May I have the first slide, please? 
 13 

1 My name is Chris Palestro, and I am the nuclear 

2 medicine physician member of the ACMUI. I appreciate the 

3 opportunity to provide some comments on training and experience 

4 requirements for the Authorized Users of alpha and beta emitters. 

5 Next slide, please. 

6 By way of some background, radioimmunotherapy of 

7 lymphoma with beta emitters was approved about 14 years ago. Two 

8 agents were approved at that time, yttrium-90 ibritumomab tiuxetan, 

9 which is known as Zevalin, and iodine-131 tositumomab; the trade 

10 name is Bexxar. 

11 Next slide, please. 

12 The use of both of these agents peaked shortly after 

13 their introduction and has steadily declined since then. Bexxar, in fact, 

14 was withdrawn in 2014 because of a lack of use, when fewer than 75 

15 patients were treated. 

16 Next slide, please. 

17 This slide simply illustrates a decreasing use of Zevalin 

18 over the course of the past nine or ten years. 

19 Next slide, please. 

20 Why has radioimmunotherapy use declined despite 

21 favorable clinical results? Is it, in fact, the direct effect of the change in 

22 Authorized User training and experience requirements that went into 

23 effect in 2006? Well, the ACMUI formed a subcommittee to look into 

24 this matter. 

25 Next slide, please. 

26 Our first charge was to determine if the current 
 14 

1 requirement of 700 hours for training and experience for Authorized 

2 Users of alpha and beta emitters places hardship on the patient 

3 community and to make recommendations for ACMUI action. 

4 Next slide. 

5 Our second charge was to establish a 

6 recommendation for the total number of hours of training and 

7 experience for Authorized Users of such emitters that appropriately 

8 balances safety with reasonable patient access. 

9 Next slide, please. 

10 Well, we sought to examine some of the factors that 

11 could possibly account for decreased radioimmunotherapy use. One 

12 factor is a lack of knowledge. Trainees, residents, fellows in 

13 hemotology/oncology are not exposed to radioimmunotherapy during 

14 their training. It stands to reason that, if they are not exposed to it 

15 during training, they are not going to be familiar with it when they enter 

16 practice and they are going to be less likely to order these therapies, if 

17 they are going to order them at all. However, a lack of knowledge 

18 about these agents really isn't a regulatory issue; it is an educational 

19 issue. 

20 What about competition from other drugs? These 

21 agents, as I just mentioned, were approved more than a decade ago, 

22 and research into treatment of lymphoma has continued since that time. 

23 There have, in fact, been new agents that have become available. 

24 Some of these agents are as efficacious, and in some cases potentially 

25 more efficacious, than radioimmunotherapy. It stands to reason that 

26 these alternatives in certain circumstances will be used rather than 
 15 

1 radioimmunotherapy. That, too, can explain some of the decrease in 

2 use of these agents. 

3 It is important to point out that this is not unique to 

4 radiotherapy, to radiation or radioimmunotherapy, that this, in fact, 

5 occurs with all sorts of therapeutic and even diagnostic procedures. 

6 As newer and more efficacious or equally efficacious, but less 

7 complicated procedures become available, they are going to be used. 

8 Next slide, please. I'm sorry, can we go back one 

9 slide? 

10 What about a shortage of Authorized Users? In his 

11 letter of February 2016 to the ACMUI, Dr. Steven Mace, who is an 

12 Authorized User and an oncologist in Florida, stated that he is unaware 

13 of a single oncologist who has become an Authorized User since the 

14 change in the training and experience requirements went into effect. 

15 Unfortunately, it is difficult to judge the significance of 

16 that statement because we have no knowledge of how many 

17 Authorized Users there were prior to the change in rules and 

18 regulations. In order to determine the effect of any change, be it an 

19 increase or decrease in rules for training and experience, or for 

20 anything else for that matter, we really need to have aggregate data 

21 over time, data which, unfortunately, are not available. 

22 Next slide. 

23 Further undermining the position that a lack of 

24 Authorized Users is responsible for a decrease in the use of these 

25 agents is the fact that, even at large institutions where there is an 

26 abundance of Authorized Users, these agents are used very 
 16 

1 infrequently, as you can see from this slide. These are just some 

2 selected but, nevertheless, quite large institutions where these agents 

3 are used very infrequently. 

4 Next slide, please. 

5 So, the Subcommittee concluded that the explanation 

6 for the decreased use of radioimmunotherapy is likely multifactorial, 

7 that the shortage of Authorized Users is certainly not the only, nor is it 

8 likely to be the primary explanation for this decreased use. Having 

9 said that, however, regardless of that, why not reduce the training and 

10 experience requirements? 

11 Next slide. 

12 The argument in favor of that is that there is an 

13 excellent safety record for radioimmunotherapy and that there is 

14 precedent for an alternative reduced training and experience 

15 requirement with the 80 hours for training and experience for I-131. 

16 But let's look, first, at the excellent safety record for 

17 radioimmunotherapy. It is important to recognize that in the vast 

18 majority of instances these radiopharmaceuticals have been 

19 administered by or in conjunction with Authorized Users who have 

20 undergone the more extensive, rigorous training and experience. By 

21 that, I mean nuclear physicians, radiation oncologists, and nuclear 

22 radiologists. Whether or not it is possible to extrapolate that safety 

23 record to individuals with considerably less training and experience 

24 really is a matter of conjecture. 

25 With respect to iodine-131 therapy, it is important to 

26 note, also, that endocrinology has a long and intimate history of 
 17 

1 involvement with radioactive iodine by virtue of its use for diagnosis and 

2 therapy of a variety of thyroid diseases. The field of nuclear medicine, 

3 in fact, to a very great extent originated in or was really born out of 

4 endocrinology and, again, radioactive iodine and thyroid disease. 

5 What about the consequences of misadministrations? 

6 Or I should say it is getting back to safety in terms of 

7 radioimmunotherapy versus I-131. It has been stated that I-131, in 

8 fact, in some circumstances it may be more hazardous and more 

9 complicated than radioimmunotherapy. 

10 Well, there are a couple of differences that need to be 

11 pointed out. No. 1, iodine-131 is given orally, and in the vast majority 

12 of cases it is given in a capsular form. So that, if it drops out of a 

13 patient's mouth, that capsule, or it drops out of the vial onto the table or 

14 onto the floor, the cleanup is relatively neat and efficacious and safe. 

15 On the other hand, if we are talking about 

16 radioimmunotherapy, it is a liquid. It is clear. It is colorless. It is 

17 odorless. If that vial shatters, if due a mispositioning or an incorrect 

18 arrangement for the injection, it winds up on the floor or on personnel. 

19 It has to be cleaned up and it is more difficult to clean up a liquid than a 

20 solid. Furthermore, it is more difficult to determine activity when we 

21 are dealing with alpha and beta emitters than when we are dealing with 

22 gamma emitters. 

23 Then, finally, another difference between I-131 and 

24 radioimmunotherapy is the fact that, again, I-131 is given orally; 

25 radioimmunotherapy is given intravenously. What are the 

26 consequences from an injection that, instead of being administered 
 18 

1 through a vein, is administered through an artery? What are the 

2 consequences of an infiltration of the radioactivity? By that, I mean 

3 injecting into the soft tissues surrounding the vein where that material 

4 was due to or supposed to be injected. Those are complications. 

5 Those are issues that are unique to injectable materials that are not 

6 issues that have to be dealt with orally-administered materials such as 

7 iodine-131. 

8 Next slide, please. 

9 So, with respect to the Subcommittee's first charge on 

10 training and experience requirements to determine if the current 

11 requirement places hardship on the patient community, after examining 

12 all of the facts, the Subcommittee came to the conclusion that the lack 

13 of use or the infrequent use of these agents is not due exclusively to or 

14 primarily due to a lack of Authorized Users. Given all of the potential 

15 issues raised by changing these requirements, the Subcommittee 

16 recommends no change in training and experience requirements at this 

17 time. 

18 Next slide, please. 

19 With respect to Charge 2, establish recommendation 

20 for the total of hours of training and experience, here the Subcommittee 

21 unanimously agreed that it is time for a thorough review of training and 

22 experience. Why? Because it has been nearly 15 years since the 

23 last review was conducted. There are new radiopharmaceuticals that 

24 are available. 

25 For example, radium dichloride, also known as Xofigo, 

26 the first alpha emitter available for treatment of metastatic prostate 
 19 

1 carcinoma; lutetium-177, DOTATATE, another agent that we anticipate 

2 will be available in the not-too-distant future. So, these agents weren't 

3 available 15 years ago. 

4 Finally, equally important is the new educational 

5 paradigm, the focus on education, certainly medical education, but 

6 education in general is no longer prescriptive based on "X" number of 

7 hours, "X" number of experiences. Rather, it is based on competency. 

8 Next slide. 

9 So, the Subcommittee's recommendation with respect 

10 to Charge 2 was to establish a standing subcommittee of the ACMUI to 

11 periodically review training and experience requirements that are 

12 currently in effect, making recommendations for changes in these 

13 requirements as warranted. In fact, the Subcommittee was 

14 established this past month. 

15 Next slide, please. 

16 The report and its recommendations were 

17 unanimously approved by the full ACMUI Committee on March 10th of 

18 this year. 

19 Thank you. 

20 At this point, I would turn the microphone over to Mr. 

21 Steven Mattmuller, nuclear pharmacist. 

22 MR. MATTMULLER: Good morning. 

23 I'm Steve Mattmuller, the nuclear pharmacist on 

24 ACMUI, and I will be presenting the highlights of our Subcommittee's 

25 Report on the Decommissioning Funding Plan Requirements for the 

26 Medical Use of Germanium-68/Gallium-68 Generators. 
 20 

1 Next slide. 

2 These two images are of the same patient. They 

3 demonstrate why there is such great interest in gallium 

4 radiopharmaceuticals. It is a patient with a neuroendocrine tumor, and 

5 you really don't have to be a physician to see the advantages of imaging 

6 with a Positron Emission Tomography radionuclide, a PET 

7 radionuclide. The image has greater resolution. That leads to 

8 greater specificity, sensitivity, and accuracy. There is the added 

9 advantage of convenience to the patient. The gallium image only 

10 takes one day to image; whereas, the older agent with indium takes two 

11 days. Another plus is that there is a lower radiation exposure to the 

12 patient with the gallium agent. 

13 As a new drug on the very near horizon, the FDA is 

14 also involved. A company called AAA, Advanced Accelerator 

15 Applications, has already submitted a New Drug Application, or NDA, to 

16 the FDA for a gallium agent for NET patients. The FDA, realizing the 

17 importance of these agents for these patients, has given it a priority 

18 review status and is expected to approve this agent within the next few 

19 months. 

20 Next slide, please. 

21 At the tip of the iceberg are the gallium agents for the 

22 NET tumor patients, as they are on the verge of clinical use here in the 

23 U.S. But lurking underneath the surface, there is a gallium agent 

24 under investigation right now for just about every tumor type. 

25 And this interest in gallium is driven by its three 

26 advantages. One, it is a PET radionuclide. Two, it is produced by a 
 21 

1 generator, a simple generator, versus a cyclotron. Three, the relative 

2 ease of converting a gallium diagnostic agent to a therapeutic agent. 

3 Prostate is emphasized here as one we currently do 

4 not have a good widely-available imaging agent for prostate patients. 

5 Two, it affects a large patient population. 

6 In regards to therapy, by replacing the gallium 

7 radionuclide from the diagnostic agent with a beta-emitting 

8 radionuclide, the new agent will retain the specificity for the tumor of the 

9 original diagnostic agent, but now it carries a beta-emitting radionuclide 

10 that can treat the tumor. 

11 This same company, AAA, will soon file an NDA to the 

12 FDA for their lutetium-177 therapy agent for neuroendocrine tumor 

13 patients. They also have in the works a lutetium177 therapy agent for 

14 prostate patients. So, these new therapeutic radiopharmaceuticals 

15 are on the near horizon also. 

16 Next slide, please. 

17 The gallium generator is a simple device that serves as 

18 a source for the gallium radionuclide. It operates in a very similar 

19 manner to those of the technetium and rubidium generators that are in 

20 use today. It has no moving parts. 

21 The parent radionuclide, germanium, is on the column 

22 and it decays to its daughter radionuclide gallium. The gallium is 

23 removed from the generator by diluting it with a dilute HCl solution. Of 

24 the two radionuclides, only the gallium is soluble in the HCl solution. 

25 So, only the gallium is removed from the generator while the 

26 germanium stays on the column. 
 22 

1 So, this is what we are talking about. This is a demo. 

2 (Laughter.) 

3 Not to worry, I am not going to try to convert you all into 

4 radiopharmacists by the end of the day. 

5 This is the first gallium generator manufactured in 

6 accordance with a Drug Master File. DMF is an FDA term. Again, the 

7 FDA has committed to the priority status of these gallium agents, as it 

8 has already inspected the production facility for this generator in 

9 Germany. 

10 And disposal is simple, as, basically, one puts it in a 

11 box and ships it back to the manufacturer. This is the very same 

12 method that is used in the U.S. right now every week for several 

13 hundred expired technetium and rubidium generators. For a licensee, 

14 this is, by far and away, the easiest and simplest way to dispose of a 

15 generator. It is the same method that we use for this generator. It will 

16 be put in a box and shipped back to the manufacturer. 

17 Next slide, please. 

18 Okay. So, this is our regulatory issue. That is, the 

19 DFP is triggered by the derived default value for unlisted radionuclides. 

20 Unfortunately for us, germanium-68 is not listed in Appendix B of Part 

21 30. So, its calculated trigger level is 10 millicuries, and 10 millicuries is 

22 too low for this generator. 

23 To prepare a DFP, it is a very extensive and expensive 

24 project. And this quote comes from John Keklak, the RSO at Thomas 

25 Jefferson University Hospitals in Philadelphia, where at their facility 

26 they tried to prepare a DFP for their facility and in the end decided it was 
 23 

1 going to be too expensive for them. So, they decided not to get a fresh 

2 generator that would allow them to use the agent in patients. They 

3 went for, in essence, an expired generator that is less than 10 

4 millicuries, so they wouldn't need a DFP. But, then, they were only 

5 able to do investigational work in animals. 

6 Likewise, for my facility in Kettering, Ohio, we would 

7 have similar issues, because the DFP covers not just the one area that 

8 the generator is used in; it covers all areas of radioactive material use 

9 within the license. At my facility we have 10 areas of use in seven 

10 separate buildings in the Kettering area. So, that is how it sort of 

11 mushrooms into this extensive and expensive proposition. 

12 We are seeing the negative effects of a DFP now, as in 

13 the U.S. there are only seven active sites for neuroendocrine tumor 

14 patients. 

15 Next slide, please. 

16 To further measure the effect of the DFP, the 

17 Subcommittee reached out to commercial nuclear pharmacies, and 

18 Triad Isotopes responded. Our report has their full statement. This is 

19 perhaps the most important, in that every patient in need would not 

20 have equal access to these radiopharmaceuticals, most especially 

21 those in smaller and more rural markets. 

22 This statement from Triad does have added substance 

23 and significance, as they have a DFP in place at four of their facilities 

24 now that operate the cyclotrons. Hence, they have firsthand 

25 knowledge and experience as to how extensive and expensive a DFP 

26 can be. 
 24 

1 Next slide, please. 

2 So, we are quite certain that the cost of a 

3 decommissioning of a medical use gallium generator does not warrant 

4 the need of a DFP. We do know that the current DFP requirements 

5 have already and will continue to limit patient access to gallium's use. 

6 Next slide, please. 

7 From our Subcommittee report, this was our proposal 

8 of creating a labeling value of 10 microcuries in the Appendix. We 

9 have two reasons why we believe we are on solid for this. 

10 First, the 10 microcuries. Dr. Langhorst of our 

11 Committee dug into the Law Library at Washington University and 

12 found all The Federal Register notices referenced in Appendix B. 

13 From those notices, she found the actual methodology that the NRC 

14 used when it first calculated the labeling values for radionuclides in this 

15 Appendix. By using this same methodology, she calculated a value of 

16 10 microcuries. That would, then, correspond to a 1,000-millicurie 

17 trigger limit for a DFP. We have extra confidence in her calculations in 

18 that this is the very same label quantity the NRC calculated for 

19 germanium-68 when it revised Appendix C to Part 20 in 1994. 

20 In addition to this, secondly, if you consider the actual 

21 decommissioning issues for the germanium in the generator -- I mean, 

22 it is practically a sealed source -- I think you have to conclude they are 

23 minimal, as to dispose of the generator, simply you put it in the box and 

24 ship it back to the manufacturer. This proposed relief would allow 

25 licensees to use the gallium generator without the burden of a DFP. 

26 Next slide, please. 
 25 

1 So, yes, the NRC is tasked with ensuring the safe use 

2 of radioactive materials in patients, but we also have a responsibility to 

3 maintain a proper balance and not to be a barrier. 

4 These three neuroendocrine tumor patients are an 

5 important reminder of why our Committee exists and why we are here 

6 today. They are holding placards that state the number of years that it 

7 took them to get an accurate diagnosis for their disease. For these 

8 patients, unfortunately, it takes them three to seven years to get an 

9 accurate diagnosis. This, of course, desperately needs to be 

10 improved, as, sadly, when most of these do finally get their correct 

11 diagnosis, their disease has progressed extensively. 

12 So, yes, these patients deserve our attention. The 

13 FDA is on track. They have given priority review to the gallium 

14 diagnostic agent. They have been to Germany to review the 

15 production of this. You have seen our initial proposal, and we are very 

16 encouraged that staff is working on an exemption and, then, the 

17 procedures for a direct final rule for relief. So, we are very encouraged 

18 and hopeful that the NRC will soon bring these two efforts to fruition for 

19 the benefit of these patients. 

20 Thank you. 

21 DR. ALDERSON: Hello again. 

22 I will close out our presentations today by addressing 

23 the important topic of communications. I will suggest ways by which 

24 the NRC staff could enhance communications with the ACMUI, as well 

25 as how the ACMUI can help enhance the NRC's relationship and 

26 communications with the medical community. Before I begin, I would 
 26 

1 like to state that the ACMUI feels that our current communications with 

2 staff are really quite good, but there is always room for improvement. 

3 Next slide, please. 

4 The ACMUI is a federal advisory committee that 

5 reports directly to the Director of the Division of Material Safety's states, 

6 tribal, and rulemaking programs within the Office of Nuclear Material 

7 Safety and Safeguards. The day-to-day activities of the ACMUI are 

8 supported by the Medical Safety and Events Assessment Branch. 

9 Next slide, please. 

10 Now this is simply a chart, a table of our organization to 

11 display our communication pathways. The dotted lines indicate our 

12 availability to speak with the Office of the Director of NMSS, with the 

13 Executive Director of Operations, and with, of course, the Commission. 

14 Our immediate past ACMUI Chairman was able to meet with all the 

15 individuals in this chain during the last fall ACMUI meeting. 

16 Now we will review current communications. 

17 Next slide, please. 

18 The ACMUI meets at NRC Headquarters twice each 

19 year, holds multiple ad-hoc teleconferences, and meets with the 

20 Commission on an annual basis. The ACMUI Coordinator is the 

21 primary conduit for transmitting and receiving communications. 

22 Next slide, please. 

23 The ACMUI informs the NRC staff about emerging 

24 medical issues, and NRC seeks input from ACMUI on medically-related 

25 topics, including rulemaking and licensing actions. 

26 Next slide, please. 
 27 

1 For various items, through NMSS Policy and 

2 Procedure 2-5, the ACMUI is provided with 60 tp 90 days for review and 

3 comments. 

4 Next slide, please. 

5 So, the ACMUI produces subcommittee reports which 

6 provide recommendations on various topics. The ACMUI's unfettered 

7 opinions are captured in papers to the Commission. But the question 

8 is, then what? 

9 Next slide, please. 

10 Now this slide is relatively brief, but the comments are 

11 relatively extensive. So, I wanted to warn you about that before I 

12 proceeded with these comments. 

13 So, per NMSS Policy and Procedure 2-5, the ACMUI's 

14 opinions in the form of that final Committee report are included in 

15 papers to the Commission for items that are pertinent for the 

16 Commission. At other times, the Committee's reports are reviewed 

17 and evaluated for other non-rulemaking activities such as licensing 

18 guidance documents. 

19 The standard process is that staff transmits a 

20 memorandum to the Committee within 30 days after a meeting to 

21 capture the recommendations that the ACMUI has made. Staff also 

22 recaps recommendations from previous ACMUI meetings during our 

23 spring and fall meetings and notes if any actions or changes have been 

24 taken. 

25 Now comes the suggestion for ways to potentially 

26 improve. A way to improve our communications with the staff would 
 28 

1 be if staff would provide us with additional feedback as to why a 

2 recommendation made by the ACMUI was not accepted or why no 

3 action was being taken. 

4 This particular issue was recognized during the recent 

5 OIG audit of the NRC's Medical Program. As a result of that audit 

6 finding, the staff has committed to transmitting formal feedback to the 

7 ACMUI with detailed explanations and responses to our 

8 recommendations. I think I speak for the whole ACMUI when I say that 

9 I think this is an excellent action from the staff. 

10 Next slide, please. 

11 Now our Committee's main objective is to provide the 

12 staff with advice as it is related to medically-related topics. In order for 

13 us to provide the best recommendations possible, the staff should give 

14 the Committee an overview of the internal processes and regulatory 

15 tools that are available to us. So, as per my conversations with staff 

16 during the fall 2015 ACMUI meeting, counsel from the Office of the 

17 General Counsel will begin giving us such training during tomorrow's 

18 closed sessions. And thank you to Ms. Esther Houseman for 

19 addressing the Committee's needs in this way. 

20 Next slide, please. 

21 All of the members on this Committee are members in 

22 other professional societies and organizations within the medical 

23 community. As NRC seeks to improve their relationships and 

24 outreach with the medical community, the ACMUI can serve as a 

25 conduit of information. Members, along with NRC staff, could speak at 

26 major society meetings. This could also shed light as to the role that 
 29 

1 the ACMUI has with the NRC staff and improve the understanding of 

2 the society members. 

3 Well, thank you for listening to our recommendations. 

4 This concludes the formal part of our report, and we are now available 

5 for questions and answers. 

6 CHAIRMAN BURNS: Thank you, Dr. Alderson, and 

7 thank you all for the presentations. 

8 We will begin questions this morning with 

9 Commissioner Ostendorff. 

10 COMMISSIONER OSTENDORFF: Thank you all for 

11 being here and for your service on the Committee. It is of tremendous 

12 importance to the agency staff and the Commission, because we do not 

13 practice medicine, that we have your upfront experience-based, 

14 professional-based insights into these critical issues. So, thank you. 

15 I am going to start out with your last presentation, Dr. 

16 Alderson. I read between the lines maybe some frustration with the 

17 NRC, but I appreciate the professional way in which you presented your 

18 comments. It was very objective. I wanted to maybe just make a 

19 couple of comments and maybe ask you a few questions. 

20 DR. ALDERSON: Sure. 

21 COMMISSIONER OSTENDORFF: Certainly, the 

22 Committee members, it is always our intent as a Commission that the 

23 Committee understands the decisions by the Commission, 

24 recommendations by the staff, et cetera. So, this agency is extremely 

25 open and transparent, and nobody is trying to play hide the ball. 

26 So, I think what we are sensing from your presentation 
 30 

1 is that perhaps we can improve in that area. Certainly, you deal with 

2 such difficult issues across your communities, within your communities, 

3 that it should not be made more difficult by lack of understanding of how 

4 we regulate. And so, I appreciate your raising the topic. 

5 I think you know that we all have open-door policies. 

6 You can come by. I know you have very busy professional schedules, 

7 treating patients, doing your normal day jobs, but I would welcome the 

8 opportunity -- and I think I speak for all my colleagues -- to have 

9 members come by and see individual Commissioners to discuss any 

10 particular issues. 

11 I think you know all of our votes on our website. So, 

12 when we deal with an issue that touches on the Committee's 

13 substantive expertise, the votes we have area all made public. 

14 Hopefully, our staff is giving you some feedback on those votes. Is 

15 that happening? 

16 DR. ALDERSON: Yes. Yes, it is. 

17 COMMISSIONER OSTENDORFF: Good. 

18 DR. ALDERSON: The reason that we are pursuing all 

19 this wide range of communication is because, yes, we bring medical 

20 expertise and advice. We don't necessarily have all the familiarity with 

21 the agency's organization and approaches, and perhaps even the 

22 agency's vocabulary and acronyms that we should have. And so, what 

23 we are really asking Ms. Houseman to do tomorrow is to go through 

24 with us some of the very basics that the people who work here every 

25 day and all of you probably understand quite well that we might not 

26 understand completely. Through learning about that, we can be better 
 31 

1 informed about the recommendations we can make and how we can 

2 pursue them appropriately within the agency. 

3 COMMISSIONER OSTENDORFF: And I applaud the 

4 Committee and OGC for facilitating those discussions. I think they are 

5 very important. 

6 Just are there any particular Commission decisions 

7 that have troubled the Committee or that have created "Well, what the 

8 heck is going on here" kind of reaction? I think we would be interested 

9 in hearing that. 

10 DR. ALDERSON: No, I don't think that is the case. I 

11 think it is more that, as the ACMUI, the experts would discuss a 

12 particular issue, one particular person would say, "Well, we can go do a 

13 guidance" and someone else could say, "We could go here." And it 

14 was clear that different members of the ACMUI didn't fully understand 

15 what was available to them, and that it would be very useful to us to 

16 have some education in that regard. So, that is why we asked for it. 

17 COMMISSIONER OSTENDORFF: Okay. Well, I 

18 really appreciate you in your role as Chairman bringing this up to the 

19 Commission. I think this was very important. 

20 DR. ALDERSON: Thank you. 

21 COMMISSIONER OSTENDORFF: So, thank you. I 

22 know that it is not anyone's intent for there to be anything other than 

23 fully-open and transparent interactions and explanations. I appreciate 

24 Esther's meeting with you all. 

25 I am going to Dr. Zanzonico. Did I pronounce that 

26 correctly? 
 32 

1 DR. ZANZONICO: Correct. 

2 COMMISSIONER OSTENDORFF: Yes, okay. 

3 I have not been here quite as long as my good friend 

4 and colleague Commissioner Svinicki, but I have been here six years. 

5 This is the first time -- and I appreciate the different opinion you 

6 provided us -- the first time I have been to the Commission meeting 

7 where there has been a suggestion that we tailor back or eliminate 

8 some of our website or information provided to the public. So, your 

9 presentation really got my attention. 

10 I think one of the values of having a Commission 

11 meeting is for us to be able to hear different views, even if they disagree 

12 with the direction that we have previously provided to our staff. 

13 So, I guess I wanted to maybe get into some of your 

14 presentation from the standpoint of the original intent, I think, and Laura 

15 has been a key player in this for many years in helping advise us on the 

16 patient advocacy side of the house. I think our original intent of this 

17 website was to provide what we think is our regulatory responsibility to 

18 the public to communicate in those limited areas within the use of 

19 radionuclides, radiopharmaceuticals to the public as to what our 

20 regulatory footprint is. 

21 I believe in the iodine-131 arena, that has been around 

22 ever since I got here in 2010; we have had many meetings on this topic, 

23 whether it be -- well, we have had a lot of meetings. I will just put it that 

24 way. And we have had lots of input, lots of letters to the Commission 

25 from many people across the United States, from Congress, and so 

26 forth. 
 33 

1 So, it really got my attention when you were suggesting 

2 that we should not be communicating in that. I think one of the original 

3 intents of the Commission and the staff was we were not seeing 

4 consistent information being communicated by the medical community 

5 to patients. I realize we are not part of the patient/physician 

6 relationship, but I think the intent was well-intentioned when it was 

7 directed a few years back, which was, hey, we are seeing an uneven 

8 practice by physicians through examples brought to the agency as to 

9 how some of these issues were being communicated. 

10 Now, having said that -- and you may agree or 

11 disagree -- I guess one thing was that some of the information we are 

12 putting out is inaccurate or misleading? 

13 DR. ZANZONICO: No, not at all. I was not 

14 questioning at all the scientific rigor or correctness -- 

15 COMMISSIONER OSTENDORFF: Okay. 

16 DR. ZANZONICO: -- of what the NRC staff is 

17 compiling. We actually haven't seen that in detail at the moment. 

18 But, knowing the people involved and just knowing the quality of work 

19 they produce, I have no doubt that what ultimately will appear will be 

20 scientifically-sound. That is not a concern. 

21 COMMISSIONER OSTENDORFF: I remember six 

22 years ago in a visit I made to the University of Pittsburgh Medical 

23 Center looking at these issues and actually seeing the instructions for 

24 patient release, and talking to our Region I staff in Pennsylvania and 

25 our staff here, I had a very small sample set. So, I am not suggesting I 

26 did a full-scale survey. But there appeared to be some variability in the 
 34 

1 practice of how some of these issues were communicated to patients. 

2 And I think that was probably the main driver for what we are trying to 

3 achieve. 

4 I want to stop right there, just because I appreciate 

5 your raising it because it is a little different from what we typically hear. 

6 And that is a good thing, for us to have differing opinions, even if they 

7 disagree with prior direction that we have provided to our staff. 

8 Laura, do you want to comment any in this area? I 

9 know you made a statement earlier, but -- 

10 MS. WEIL: Again? 

11 COMMISSIONER OSTENDORFF: But I will give you 

12 the opportunity if you want to. I know you have already commented on 

13 it, but -- 

14 MS. WEIL: No, I think the portal is going to be 

15 extremely useful, in that it is going to bring up the discrepancies in 

16 information that patients receive. Also, it will raise the issue because 

17 patients will communicate as well their frustration with a lack of 

18 information that they are receiving, which just shows that there is a lack 

19 of consistency across this issue in the way patient care is provided. 

20 COMMISSIONER OSTENDORFF: Thank you. 

21 DR. ZANZONICO: If I may just follow up? 

22 COMMISSIONER OSTENDORFF: Please. 

23 Absolutely, yes. 

24 DR. ZANZONICO: There is no disputing that there is 

25 inconsistency, lack of uniformity, however you want to characterize it, in 

26 the instructions and information that is conveyed from treating 
 35 

1 physicians to their patients. 

2 The concern I have, and at least some of the members 

3 of the Committee have -- and I think physicians have encountered this 

4 not just in context, but in others where a patient comes in and says, "But 

5 the internet says this." 

6 COMMISSIONER OSTENDORFF: Yes. 

7 DR. ZANZONICO: And, of course, we know 

8 everything on the internet is accurate. 

9 But that is the real concern, that we think that the 

10 appropriate line of communication in the entire scope of patient care is 

11 directly from the physician and allied health professionals -- 

12 COMMISSIONER OSTENDORFF: Yes. 

13 DR. ZANZONICO: -- to the patient. The concern is 

14 that a website with the imprimatur of the NRC may convey information 

15 that is generally accurate, but, for example, may not be appropriate in a 

16 particular patient's case. And now, the patient confronts the 

17 physician -- "confront" is probably not the right word -- saying, "The 

18 NRC recommends or says this. You're telling me this. What's 

19 correct? What's true?" and so forth. 

20 So, that is the concern, that no website, no matter how 

21 credible, no matter how scientifically-sound, can address all of the 

22 vagaries in patient care and really substitute for the physician who has 

23 firsthand knowledge, obviously, of the patient situation. It is this 

24 potential for conflict that, as I said, I feel may exacerbate anxiety and 

25 confusion among patients. 

26 COMMISSIONER OSTENDORFF: Okay. 
 36 

1 DR. ZANZONICO: So, that is my concern. 

2 COMMISSIONER OSTENDORFF: I think I probably 

3 have a different view, but I respect your view. I'm not a physician; you 

4 are. I know that when I have gone through a major surgery procedure 

5 here and have gone through cancer treatment myself, I found a lot of 

6 benefit in being able to go to a website. 

7 I don't know that The New England Journal of 

8 Medicine, which I did go to for several of my research efforts for cancer 

9 treatment for myself -- I struggled a little bit to figure out where the best 

10 information was. 

11 And so, I will leave it at that. I just appreciate your 

12 raising the issue today. Thank you all. 

13 CHAIRMAN BURNS: Thank you, Commissioner. 

14 Commissioner Baran? 

15 COMMISSIONER BARAN: Thanks. Well, thank you 

16 all for being here and for your work and your presentations today. 

17 Dr. Palestro, I want to start with some questions 

18 focused on the alpha and beta emitters question and the training and 

19 education requirements there. 

20 I looked at the Subcommittee report that came up, and 

21 it didn't really discuss the relative risks to patients or to the public of 

22 alpha and beta emitters generally as compared to gamma emitters or 

23 iodine-131. You talked a little bit about that today, actually, in your 

24 presentation, but I was hoping to hear a little bit more about that. 

25 You know, compared to gamma emitters or iodine-131, 

26 are beta emitters generally lower risk to the patients and are they lower 
 37 

1 risk to the public, or is that not the case? 

2 DR. PALESTRO: Well, I think that is a difficult 

3 question to answer because, as I at least tried to indicate in the slides, 

4 they are really very different. If we talk about misadministration in 

5 terms of amount of administered activity, I think it would be hard to 

6 argue that one is more or less hazardous to the patient. If we gave 

7 twice the amount of radioactive iodine, and let's talk about thyroid 

8 cancer as opposed to hyperthyroidism, certainly, the potential side 

9 effects in terms of myelosuppression, lowering blood counts are 

10 potentially there; equally so with alpha and beta emitters. So, there I 

11 would say that the risks are comparable. 

12 COMMISSIONER BARAN: You talked a little bit 

13 about spill issues. 

14 DR. PALESTRO: Yes. 

15 COMMISSIONER BARAN: What about more broadly 

16 in terms of risks to the public, in terms of folks being released and those 

17 types of issues that come up in iodine -- 

18 DR. PALESTRO: The answer is certainly with I-131, 

19 because of the more energetic photons that are emitted, there is a 

20 greater risk of exposure to the public. We are assuming now that 

21 everything has been administered correctly and we are putting 

22 misadministration aside. 

23 On the other hand, alpha and beta emitters travel a 

24 much shorter distance. So, exposure to the public or risks to the public 

25 are going to be less. 

26 COMMISSIONER BARAN: Okay. But, going back 
 38 

1 to misadministration, what I am hearing is, if the question is 

2 misadministration, alpha and beta emitters have comparable risks to 

3 gamma and iodine? 

4 DR. PALESTRO: In terms of if we are talking about 

5 misadministration, excess amount of activity administered. 

6 COMMISSIONER BARAN: Okay. 

7 DR. PALESTRO: On the other hand, if we are talking 

8 about a misadministration where we have the leakage of the dose into 

9 the surrounding soft tissues or an intra-arterial injection as opposed to 

10 intravenous, that is unique to any injectable radiopharmaceutical. It is 

11 not going to happen with iodine-131 because that is administered only 

12 orally. 

13 COMMISSIONER BARAN: Okay. So, there is no 

14 simple, clear answer to this question about, well, this is lower risk than 

15 this other thing? I mean, if you are looking at categories, alpha, beta, 

16 gamma, iodine, if we break out separately, it is kind of complex? 

17 DR. PALESTRO: I think that is an accurate way to 

18 characterize it, that it is a complex issue, and each of these agents has 

19 their own set of risks that in some circumstances are unique to them. 

20 COMMISSIONER BARAN: Okay. So, right now, of 

21 course, the regulatory construct we have here is there is one training 

22 and experience requirement of 700 hours for using the full spectrum of 

23 nuclear medicine. I think, based on all the letters we are getting and 

24 the conversations that we are hearing, there is this, I guess, policy 

25 question about whether or not, as an agency, we should explore having 

26 more tailored training and education requirements for certain classes of 
 39 

1 radiopharmaceuticals. Is that something that you all have talked about 

2 in the Subcommittee or Committee? What are your thoughts about 

3 that type of approach and how complicated do you think it would be to 

4 do that? 

5 DR. PALESTRO: The answer is the purpose of the 

6 Subcommittee that has been formed, the new Subcommittee, is 

7 specifically to look at that issue. 

8 COMMISSIONER BARAN: Okay. 

9 DR. PALESTRO: Should it be a unified set of training 

10 and experience requirements? Should it be divided by category? In 

11 fact, one of the letters we received from Hilliard, et al., suggested that 

12 the training and experience and authorization for use be limited to 

13 specific radiopharmaceuticals as opposed to classes of 

14 radiopharmaceuticals. 

15 So, the answer is it is a very complex issue. I think it 

16 does need to be looked at extensively, and I think that it is something 

17 that takes time. It is just not something that can be accomplished in a 

18 matter of weeks or months. I think it has to be looked at over time. 

19 Figure out what exactly we mean by competency, and then, work 

20 backwards. Once we have said this is what we expect the Authorized 

21 User to be capable of doing, determine, so to speak, in a retrograde 

22 fashion what sort of training and experience are involved, without 

23 getting into preconceived notions about numbers of hours and numbers 

24 of actual cases that qualify for experience. 

25 COMMISSIONER BARAN: Okay. And 

26 understanding that you all are just starting to look at this, at this stage 
 40 

1 do you have kind of an intuition about, if we were going to take a 

2 category approach, classes of radiopharmaceuticals, do you have a 

3 sense about the number of classes we would be talking about? Is it 

4 going to be alpha, beta, gamma, iodine or is it going to be more 

5 complicated than that likely? 

6 DR. PALESTRO: I think it would be injectable alpha 

7 and beta emitters and, then, orally-administered radiopharmaceuticals, 

8 which in this case is I-131. 

9 COMMISSIONER BARAN: Okay. 

10 DR. PALESTRO: It is difficult to really look that far 

11 into the future -- 

12 COMMISSIONER BARAN: Yes. 

13 DR. PALESTRO: -- because that is what we are 

14 dealing with at the moment. But I would think we would be focusing on 

15 classes. Specific radiopharmaceuticals in one sense is kind of 

16 interesting, but I think it also may become overly-burdensome and 

17 unnecessarily and excessively regulated. But, again, that is just sort of 

18 a preliminary thought of my own. 

19 COMMISSIONER BARAN: Yes. 

20 DR. PALESTRO: And the Subcommittee hasn't 

21 looked at it in-depth. 

22 COMMISSIONER BARAN: What do you think, as you 

23 embark on this, what kind of level of effort is going to be necessary to 

24 develop the safety case for any particular training and education 

25 requirement for any particular potential class of drugs? 

26 DR. PALESTRO: I think the initial development for 
 41 

1 one class -- we will just focus on one class -- 

2 COMMISSIONER BARAN: Yes. 

3 DR. PALESTRO: -- will be fairly difficult and 

4 comprehensive and will take a lot of vetting. I think once it is 

5 established for one class, we will have a template for other classes. 

6 COMMISSIONER BARAN: Okay. And you 

7 mentioned and the Subcommittee report discussed a little bit about this 

8 shift in education to something that is more kind of competence-based 

9 as opposed to precise hours. Again, I know this is something you will 

10 be looking at as part of the new Subcommittee. 

11 But talk to us a little bit about what do you see as the 

12 potential implications for NRC's role of looking at more of a 

13 competence-based approach? What is that going to look like? Are 

14 we talking about a situation now where NRC has exams for doctors on 

15 radiological safety? I mean, it seems at least at a conceptual level in 

16 tension with the idea that we are not going to get involved in the practice 

17 of medicine, to judge whether an individual doctor has the competency 

18 to do something safely. 

19 DR. PALESTRO: That is really looking far into the 

20 future. But, certainly, one of the ways that competency is judged is by 

21 examination. Competency really isn't measured exclusively by "X" 

22 number of experiences; for example, three administrations of a 

23 particular radiopharmaceutical. That may be competent for some 

24 individuals. It may be more than enough for others. It may be 

25 nowhere near enough for still other individuals. 

26 So, there has to be some measure of competency. 
 42 

1 While I am not suggesting, and I don't think the Subcommittee is going 

2 to suggest, that the NRC develop examinations, there is, in fact, a 

3 precedent that was set by the American Board of Endocrinology where 

4 they have the Certification Board in Nuclear Endocrinology, in which 

5 they have developed a program for training and experience, at the end 

6 of which the individuals who must be Board-certified in endocrinology 

7 take an examination. Once they are certified by the Certification Board 

8 in Nuclear Endocrinology, those credentials are accepted by the NRC 

9 for Authorized User status. 

10 So, that might be, ultimately, what I personally -- and I 

11 am not speaking for the Subcommittee or the ACMUI -- personally 

12 might envision, the establishment of some sort of certification board 

13 that would give the NRC confidence that these individuals are, in fact, 

14 qualified to administer these agents. 

15 COMMISSIONER BARAN: Okay. Thank you. 

16 DR. ALDERSON: Dr. Alderson here. I would like to 

17 just comment on that because I have thought about that. I thought Dr. 

18 Palestro's answer was actually quite good. 

19 But I don't personally see -- again, now speaking as 

20 myself and not for the Committee overall -- that we would ever get 

21 involved in testing. But if we had ideas about what defined 

22 competency or the capability to be safe, you could virtually issue an 

23 RFP and go out and try to find people or organizations that would say, 

24 "Well, we could do this for you." We could do it in such a way that we 

25 could establish the qualifications and periodically review those 

26 qualifications in a certain way. Then, that might be sort of a decision 
 43 

1 approach that you could make. 

2 Part of what I think we are dealing with here, I think that 

3 many of the things we have discussed in the last few minutes have to 

4 do with sort of the education-versus-regulation question, which is a 

5 difficult balance. I think they do exist on a continuum. So, we have to 

6 work with you to try to find the right balance for communication, which is 

7 a form of education, down to when does it become regulation and how 

8 do you stay away from getting parts of the community concerned that 

9 there is too much regulation. I think more education will help with 

10 regulation and, ultimately, help with safety. So, it is going to be an 

11 ongoing process, and we are very interested in getting started. 

12 COMMISSIONER BARAN: Thanks. 

13 I wanted to ask Mr. Mattmuller just one quick question 

14 on the germanium/gallium generator issues. So, I take your 

15 comments, your view is that a decommissioning funding plan isn't 

16 necessary because decommissioning is very easy. It just returns to 

17 the manufacturer. 

18 My question on that is just, is the manufacturer 

19 contractually or otherwise legally obligated to take back from the 

20 licensee the generators at the end of their useful life? 

21 MR. MATTMULLER: This generator is manufactured 

22 by Eckert & Ziegler, a German company. I believe there is a second 

23 generator company called ITG that is on the verge of also having their 

24 DMF approved by the FDA. Both of those companies are in Germany. 

25 By German law, they are required to take back any gallium generators 

26 that they produce. 
 44 

1 COMMISSIONER BARAN: Okay. Thank you. 

2 Thanks again. 

3 CHAIRMAN BURNS: Thank you, and thank you all 

4 for your presentations. 

5 I want to come back to the germanium generators. 

6 But just to reflect on some of the discussion we have been having on 

7 this education requirement, I think Dr. Alderson's comment is very 

8 interesting, this intersection between regulation and education. In fact, 

9 what we have now is regulation that says education must be 700 hours. 

10 And so, the question, and I think what we are getting on this side, is a lot 

11 of letters saying, "Is that really the case? Is that the necessity of 

12 education in terms of safe use, safe administration of 

13 radiopharmaceuticals?" So, I think we will all be very interested as this 

14 goes on in terms of the Subcommittee about where that balance is and 

15 where the interplay finally comes. 

16 Dr. Palestro, what do you foresee in terms of sort of a 

17 course of work for the Subcommittee on this question, on the 

18 educational requirements? What sort of planning? I realize you can't 

19 plot out perhaps a particular endpoint, but just sort of give me some 

20 flavor of where you see them, where you see you all going as to this. 

21 DR. PALESTRO: Well, I think the first thing we need 

22 to do is determine the various boards that have the so-called deemed 

23 status by the NRC, figure out and determine where those Authorized 

24 Users are coming from, just so you have some sort of baseline. I think 

25 that is important. 

26 Then, I think we need to look at what we deem as the 
 45 

1 requirements for an individual to be competent as an Authorized User. 

2 What do they need to be familiar with, handling the 

3 radiopharmaceuticals administration of radiopharmaceuticals, radiation 

4 safety, items like that? 

5 And then, finally, we also need to try to determine what 

6 constitutes competency in those areas. From that point, I would think 

7 we would work backward to hours and experience. In other words, 

8 start out with competency and, then, try to determine -- and I don't think 

9 it is an easy task -- but try to determine what amount of hours and 

10 experience is required, because there is always going to be some 

11 minimum that is required. 

12 I think -- and again, I am going to speak for myself and 

13 not for the Subcommittee or the entire ACMUI -- given the excellent 

14 track record in terms of safety that the current requirements of 700 

15 hours have for training and experience, we are not going to recommend 

16 an increase in those hours at all. But whether or not we recommend a 

17 decrease I don't know yet. 

18 CHAIRMAN BURNS: Okay. And help me out, just to 

19 refresh my recollection. The current 700, it is a mixture of classroom 

20 and, then, doing the medical -- 

21 DR. PALESTRO: Yes, it is, I believe, 200 hours of 

22 didactic experience -- 

23 CHAIRMAN BURNS: Okay. 

24 DR. PALESTRO: -- with 500 hours of, quote/unquote, 

25 "clinical experience". 

26 CHAIRMAN BURNS: Okay. 
 46 

1 DR. PALESTRO: Eluting generators, preparing 

2 radiopharmaceuticals, so forth. 

3 CHAIRMAN BURNS: Yes. Okay. I think I have an 

4 hour in. I visited Inova Fairfax, and they had me doing a couple of 

5 things. It was actually very interesting a couple of weeks ago. I have 

6 a greater respect for those who actually have qualified and are doing it, 

7 demonstrating, for example, a seed implant for prostate cancer and one 

8 of the others. But I am nowhere near qualified. 

9 I want to talk, Mr. Mattmuller, about -- and you may 

10 have answered my question in response to Commissioner Baran -- but, 

11 with respect to the generators, I think what you said is, currently, 

12 basically, the manufacturer -- or these generators are coming from 

13 Germany. It is an import from Germany. I think what you said is, 

14 under German law, basically, they have the responsibility -- because 

15 one of my questions was, how does Germany treat the disposition of 

16 these? I think what I heard you say was, basically, under the German 

17 law, that the manufacturers are required to take back. So, they are 

18 responsible for the ultimate decommissioning and disposal, et cetera. 

19 I take it in a way, because, for all I know, at some point 

20 there might be an American company, a Canadian company, or others 

21 who might be interested, it seems to me that I think what you are saying 

22 is that, if you have -- again, with licensed material, whether it is in the 

23 medical area, whether it is reactor fuel, whether it is radiography device, 

24 or whatever, the whole question is responsibility for possession, while 

25 in possession, responsible for the appropriate use, licensed use, and 

26 control, and ultimate disposition. 
 47 

1 So, what I think I hear you saying, if there is an 

2 assurance in the system -- and that might be demonstration through 

3 contract or some other means -- that, basically, the hospital or the user 

4 has a right to return, and the manufacturer or the supplier has an 

5 obligation to return. That seems to be almost the linchpin or the key 

6 piece that would help, from your standpoint, this notion of either an 

7 exemption or an exception in the rule. Do I have that right? And then, 

8 please elaborate. 

9 MR. MATTMULLER: Yes, sure. You said "the right 

10 to return". Actually, for this generator, and just to back up, and maybe 

11 I can bore you a little bit more about the other generators, in regards to 

12 technetium generators, especially the large ones that have the depleted 

13 uranium shield, if you use that generator, you are required to send it 

14 back to the manufacturer, primarily because of the expense of the 

15 shield. 

16 For a rubidium generator, because of the long half-life 

17 of the parent radionuclide strontium-82, it is impractical for a site/a 

18 licensee to dispose of that onsite by decay in storage. So, that is 

19 recognized by the current manufacturer, Bracco. So, they, too, require 

20 those generators to be sent back to them for proper disposal. 

21 So, this really fits into that same pattern. It is not that 

22 we -- I guess you can say we do have a right, but it is almost like we are 

23 required to send it back to the manufacturer for disposal. In this day 

24 and age purchase agreements, and they used to be this big when I first 

25 started, and now they are several pages. But, of course, for this 

26 generator, there is a full page -- or I shouldn't say a "full page" -- but 
 48 

1 there is a specific clause on the return of the generator when it is 

2 expired back to the manufacturer. 

3 CHAIRMAN BURNS: Okay. So, it does seem to me 

4 that, as I say, you indicated an interesting sort of developmental history 

5 here between the last revision, Part 20, in the early nineties; also, Part 

6 30 in terms of how some of the exemptions and quantities are stated. 

7 Sort of an interesting development. 

8 But, again, it does seem to me that seems to be the 

9 linchpin or the strongest argument perhaps or a strong argument for 

10 allowance of an exemption or some similar regulatory device that Ms. 

11 Houseman will explain more about tomorrow, apparently. That might 

12 provide the basis for such an exemption. 

13 Okay. I wanted to follow up on some comments 

14 Commissioner Ostendorff made with respect to I think the staff's 

15 initiative in terms of looking sort of at this website communication. I 

16 think it is recognized that we are in a day and age where you are going 

17 to have information out there. 

18 To the extent that we provide information out there, we 

19 have to make sure, I think, it is accurate. When I took a look at what I 

20 think is this sort of experimental, if you will, site now, perhaps some of 

21 what might be more useful on it is if it does address some of the 

22 concern that you have in terms of the question of practice of medicine, 

23 that you need consultation with the physician, consultation with the 

24 expert is something that may need to be emphasized. 

25 On the other hand, what I see is references to various 

26 societies, other expert panels where other information is. And maybe 
 49 

1 it is the contexting that could be improved. 

2 Either Ms. Weil or Dr. Zanzonico can comment on that. 

3 DR. ZANZONICO: Well, I would hope that, at the very 

4 least, there would be a very emphatic statement on any such website 

5 that, as with other educational materials created generally, that it does 

6 not substitute for information, advice, recommendations, and so forth, 

7 by the patient's physician. I think that is a minimum standard for any 

8 informational mechanism. 

9 Beyond that, until there is a draft site, and so forth, 

10 available for review, it is difficult to comment on the specifics. 

11 CHAIRMAN BURNS: Okay. 

12 DR. ZANZONICO: My comments were really more 

13 philosophical -- 

14 CHAIRMAN BURNS: Okay. 

15 DR. ZANZONICO: -- than any detailed assessment of 

16 what might or might not be on a site, but certainly a disclaimer 

17 emphasizing the primary role of the physician/patient relationship I think 

18 would be a minimum requirement. 

19 CHAIRMAN BURNS: Okay. Thanks. 

20 Ms. Weil? 

21 MS. WEIL: I think something that the site has already 

22 demonstrated is that there is a surprising unknown percentage of 

23 patients who get very little to no information about release instructions 

24 from their physicians. This is a method of promoting from the patient 

25 side a conversation with the physician to get the information that they 

26 need, which will be of benefit to everyone. 
 50 

1 CHAIRMAN BURNS: Okay. Thank you. 

2 My time is up. Commissioner Svinicki? 

3 COMMISSIONER SVINICKI: Thank you all again. 

4 Let me begin by expressing in the most heartfelt way that I can my 

5 gratitude for the work of the Committee, not just the members who 

6 presented at the table today. I know a number of other Committee 

7 members are here sitting in the audience. 

8 It is my observation that the NRC's regulation of some 

9 of these medical issues is not always the most comfortable fit with the 

10 remainder of our regulatory framework, partly because the issues are 

11 different in many ways than what we regulate in other areas of our 

12 regulatory framework. 

13 My confidence would be lessened, I think, quite a bit in 

14 the appropriateness and correctness of our regulatory outcomes, but 

15 for the existence of your Committee. Your Committee does report to 

16 the NRC staff. I consider that is just one of the vagaries of advisory 

17 committee law and regulation, unlike our Advisory Committee on 

18 Reactor Safeguards, which is in the Atomic Energy Act. 

19 I view it also as a strength because it is a little bit of a 

20 workaround, but I think the strength of the ACMUI is it is absolutely 

21 essential that we have current practitioners who are out in the field, 

22 again, working directly on these issues. It is a very dynamic area of 

23 medical technology. I think that if we had to have retired individuals 

24 and others, so that they would have maybe less direct interest in the 

25 regulatory outcomes, I think that we would suffer from having 

26 individuals who were not as contemporary on these issues in medical 
 51 

1 settings. 

2 And so, I view the fact that the ACMUI does not advise 

3 the Commission directly or its recommendations do not flow directly to 

4 the Commission, it certainly in no way is reflective in my observation of 

5 the significance of the Committee's work product. Every member of 

6 this Commission I have ever served with, including the present 

7 company, gives very heavy weight to the Committee's input and 

8 recommendations. 

9 We may occasionally arrive at a decision that is a 

10 modification or a departure from what you recommend. At our level as 

11 Commissioners, we have broad other public policy and regulatory and 

12 legal considerations. So, sometimes we have a balancing of factors 

13 and that may modify the Committee's input. I appreciate your 

14 recognition of that here today. I feel that in a number of your 

15 responses there was recognition of that. 

16 And certainly, the reporting which was in one of the 

17 early charts, the reporting scheme is not in any way reflective, in my 

18 view, of the degree of importance of your work very directly to the lives 

19 of American people every day, which is a very, very direct connection 

20 between your expertise and advice to our regulatory processes. 

21 So, I just wanted to take a moment to express that to 

22 each of you. I am sure it is very difficult to balance your other work with 

23 your service on this Committee. I appreciate that you all do that. In 

24 my experience over, yes, Commissioner Ostendorff, a very long 

25 number of years, all members of the Committee serving and previous 

26 members do that very well. And I am very grateful for it, as a member. 
 52 

1 As a decisionmaker, these are tough decisions for us. 

2 Again, I reside a lot of confidence in the existence of the ACMUI, and 

3 they are playing a role in these decisions, not always the decider, but 

4 playing a very important role in the decisions. 

5 So, I will turn to communications. I have talked about 

6 the reporting chain. I think I don't want to beat the Patient Release 

7 Project website to death because we have talked a lot about it. 

8 Dr. Zanzonico, your comments were not at all 

9 surprising to me. I just need to take a moment to remind us all of how 

10 the Commission came to direct the NRC staff to develop that website. 

11 It was not the NRC staff's recommendation to us, and the ACMUI 

12 broadly had expressed a number of concerns about what is a 

13 potential -- and I say just "a potential" -- intrusion or insertion of NRC 

14 between a doctor and a patient. 

15 Two members of the Commission, including its 

16 Chairman at that time, took up a personal advocacy on this issue. And 

17 the staff was engaged in a longer-term project of assessing the 

18 circumstance and coming back to us. The Commission as a whole 

19 truncated that process by its own choosing and moved forward. 

20 I was the sole vote disapproving moving forward at that 

21 time. I thought it was premature at best, and in the absence of full 

22 vetting by the staff and a recommendation, my concern was we might 

23 inadvertently, contrary to the adage that something is better than 

24 nothing, in the case of a bad website, I thought -- and I took the 

25 concerns to heart -- that a bad website would be worse than nothing. 

26 So, it was not the staff's recommendation. It was not the ACMUI's 
 53 

1 recommendation. 

2 And so, I really respect the concerns that you have 

3 expressed. Now our very capable patient advocate has also reminded 

4 us of a number of sensitivities, and I weight those heavily and those are 

5 very valid as well. 

6 But I do think we arrived at this through something that 

7 originated with the Commission itself. I worried about this potential 

8 insertion of something. 

9 Again, I am going to go out to the website or many 

10 websites and look for information if I am a patient. But the person who 

11 knows my case best is my medical care provider. 

12 And so, I hope we will do it well. The staff, I don't have 

13 any doubt, even though this wasn't their idea, they are extremely 

14 professional. 

15 What I would urge you to do is please continue to raise 

16 any issues or concerns about information we are putting out. I am not 

17 going to beat up on you about it. I think it is important. 

18 I didn't share the view that necessarily we should do 

19 this or do this without a little more work by the staff. That decision is 

20 made. I am not relitigating that. But the most important thing now, if it 

21 is out there, is that it be something that is constructive as opposed to 

22 something that just increases patient's and loved one's anxiety about 

23 why is the NRC saying this and your doctor said something else. So, I 

24 don't want to beat up on that anymore. 

25 I will say a lot of my colleagues have asked about the 

26 training and experience requirements. I don't know what the answers 
 54 

1 are there, but the one thing that resonates with me is your 

2 recommendation for a broad relook, that it is time. It has been 15 

3 years. That sounds about right. 

4 I think I have one question there, though, for anyone 

5 who would like to answer it. What is your confidence about our ability 

6 to put in place something enduring if it takes the form of a stratified 

7 injectables versus things delivered orally or if it is based on the modality 

8 or the therapy? 

9 The one thing I took from Dr. Palestro's presentation 

10 was how dynamic the treatment or development of therapies, 

11 diagnostics, the various modalities, that is dynamic. We don't change 

12 our regulations terribly frequently. So, do you think that we can get to 

13 something that is informed in an enduring way, that we won't have to 

14 change 500 hours to 100 hours or do that? What is your view on our 

15 prospect there? 

16 DR. PALESTRO: You know, it is always difficult to 

17 look far into the future because we don't know everything that is 

18 developing. I would hope that the final product will be one that is both 

19 comprehensive and flexible and can encompass degrees of change. I 

20 think there are going to be changes that may be beyond what we could 

21 have envisioned, and we will deal with it when it comes. So, again, it 

22 should be comprehensive, but flexible to the extent that we can make it. 

23 COMMISSIONER SVINICKI: And I appreciate that. 

24 Maybe the answer was a little bit unanswerable because it was asking 

25 for a crystal ball. I think more truly new things, it is hard to encompass 

26 in any regulatory proposal. But maybe what I am suggesting is, as you 
 55 

1 approach your recommendations in this area, you are getting a sense 

2 or you will hear more tomorrow about how long our rulemaking process 

3 is. Maybe standard timeframes will be presented to you. 

4 If you could maybe recommend with that at least a 

5 consideration. You said, you know, enduring things that encompass at 

6 least what we foresee. As far as I am concerned, that is the right 

7 mindset to move forward. 

8 And I will just close with a comment -- I don't know if I 

9 have a question -- on the germanium/gallium generator issue. I do 

10 appreciate that presentation. I view this as ACMUI helping NRC look 

11 over the horizon or get on top of something before it becomes a big 

12 issue. 

13 Speaking only for myself, I at this point assess that the 

14 staff is looking at the issue and perhaps drafting some sort of direct final 

15 rule or exemption. I don't know what final form that would take and 

16 what ultimately will be decided, but that work to move in that direction 

17 clearly seems appropriate to me, as an individual member of the 

18 Commission, because I think at bottom that patient image that you, Mr. 

19 Mattmuller, began your presentation with, you could just begin and end 

20 with that. 

21 For me or my loved ones, if we could have the benefit 

22 of the imaging, that is, the difference between those two, the difference 

23 that could make in the treatment, the care of a patient to me is so telling. 

24 And I am not medically expert in anything, but, clearly, we don't want 

25 our regulatory framework to stand as an arbitrary non-safety, 

26 non-risk-related obstacle to people having broader access to that kind 
 56 

1 of imaging. 

2 So, I have talked a lot, but, just quickly, did anyone 

3 have anything they felt they really needed to add? If not, I will yield 

4 back, Mr. Chairman. 

5 MR. MATTMULLER: Actually, I had a thought in 

6 regards to your comments, Chairman Burns. In regards to the 

7 contractual requirements for sending it back, I was thinking, well, what 

8 is the alternative? As you might suspect, I am old enough to 

9 remember for technetium generators we used to store them in decay for 

10 storage to dispose of them. But that required holding onto the 

11 generator, dismantling it, pulling the column out that had the parent 

12 radionuclide on it. And then, for technetium, it is a 2.8-day half-life. 

13 So, it is at least two months, and then, storing that, but, then, going back 

14 and verifying with your survey meter that, yes, indeed, the column has 

15 decayed to background. And then, you can dispose of it. 

16 Fortunately, the manufacturers developed programs 

17 where you can either do all that extra work or it can be simpler and just 

18 send it back to us. And so, the field has evolved, especially in the case 

19 of the more expensive shields, or the rubidium generator it is a much 

20 longer half-life, or it is not practical to store the columns in your closet. 

21 It is routine, I guess, is the word I want to put out there. It is just 

22 routine. That is what we do now, yes. 

23 CHAIRMAN BURNS: Yes. Thanks for that. 

24 Thanks for the explanation. It does tell you in terms of how, you know, 

25 the use, the technology, the market has developed in terms of how, and 

26 is developing in terms of how the devices are used and the practicalities 
 57 

1 of how they are handled, stored, and disposed of. So, thanks for that 

2 additional thing. 

3 Again, we appreciate the presentations by the 

4 Committee members who are at the table, but, as my colleague has 

5 said, we appreciate the service of those others who are sitting in the 

6 background there. I recognize a number of you who also serve on the 

7 Committee. We appreciate the work. As we have all indicated, I think 

8 it is extraordinarily useful in terms of informing us in terms of our 

9 general safety mission, but particularly in the area of the intersection 

10 with medical applications of radioactive material. So, again, thank 

11 you. 

12 With that, we are adjourned. 

13 (Whereupon, at 11:05 a.m., the meeting was 

14 adjourned.) 

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