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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PUBLIC MEETING 

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TUESDAY, 

APRIL 14, 2015 

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The Commission met in the 

Commissioners' Conference Room, 1st Floor, 11555 

Rockville Pike, Rockville, Maryland, at 9:30 a.m., 

Stephen G. Burns, Chairman, presiding. 

PRESENT

STEPHEN G. BURNS, Chairman 

KRISTINE L. SVINICKI, Commissioner 

WILLIAM C. OSTENDORFF, Commissioner 

JEFF BARAN, Commissioner 

ALSO PRESENT

BRUCE THOMADSEN, ACMUI Chair 

FRANCIS COSTELLO, ACMUI Member 

VASKEN DILSIZIAN, ACMUI Member 

CHRISTOPHER PALESTRO, ACMUI Member 

LAURA WEIL, ACMUI Member 
 2 

MARGARET M. DOANE, OGC 

ANNETTE L. VIETTI-COOK, SECY 
 3 

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

2 9:35 a.m. 

3 CHAIRMAN BURNS: Okay. I want to welcome 

4 our ACMUI members here today, and we're holding this 

5 meeting with the Advisory Committee on the Medical 

6 Use of Isotopes. This is an opportunity for the 

7 members of the Committee to provide their views on 

8 significant issues that have come before the 

9 Committee. 

10 Before we begin, on behalf of the 

11 Commission I would like to take this opportunity 

12 to congratulate Dr. Bruce Thomadsen, Chairman of 

13 the Advisory Committee, on his recent honor of being 

14 presented with the Ulrich Henschke Award by the 

15 American Brachytherapy Society. I understand this 

16 is the highest honor that the Society can bestow 

17 on a practitioner in the area, and so we're very 

18 fortunate here at the NRC to have someone whose 

19 achievements are well recognized serving as the 

20 Chair of the Committee and providing guidance to 

21 the Staff. 

22 DR. THOMADSEN: Thank you very much. 

23 CHAIRMAN BURNS: You're welcome. You're 

24 welcome. 

25 We're going to be briefed today by 

26 several of the Committee members on various topics. 
 4 

1 Chairman Thomadsen will provide an overview of the 

2 Committee's work since our last meeting, and the 

3 work that remains ahead. Ms. Laura Weil will discuss 

4 Patient Rights issues before the Committee. Dr. 

5 Vasken Dilsizian will discuss the Committee's 

6 comments on the Advance Notice of Proposed 

7 Rulemaking for 10 CFR Part 20. Dr. Christopher 

8 Palestro will discuss molybdenum-99 production and 

9 impacts on the medical community. And Mr. Francis 

10 Costello will discuss the Committee's views on 

11 yttrium-90 microsphere brachytherapy, and I want 

12 to say hi to Frank who I worked with many years on 

13 the Staff when I was an attorney here, an earlier 

14 NRC career. 

15 The presentations will be followed by 

16 a Question and Answer session with the Commission. 

17 Before I begin --- before we begin, would any of 

18 my Commissioner colleagues like to make any remarks? 

19 And is Commissioner Svinicki on the phone pending 

20 her --- 

21 MS. VIETTI-COOK: I don't know. 

22 Commissioner Svinicki, are you still on the phone? 

23 CHAIRMAN BURNS: No, okay. Hopefully, 

24 the traffic will clear. 

25 So again, Chairman Thomadsen, would you 

26 please begin your presentation. 
 5 

1 DR. THOMADSEN: Thank you very much, Mr. 

2 Chairman. It's a pleasure to be able to come and 

3 tell the Commission exactly what we've been up to, 

4 and we've been up to an awful lot lately. 

5 The ACMUI exists to advise the NRC Staff 

6 and that way you, the Commission, on policies of 

7 medical uses of radionuclides. Also, to provide 

8 technical assistance and serve as consultants to 

9 the Commission. Next slide, please. 

10 We have members of the Committee that 

11 represent various stakeholders in the medical 

12 radiation arena, including health care 

13 administrators, nuclear medicine physician and a 

14 physicist, two radiation oncologists, and a medical 

15 physicist, nuclear cardiologist, diagnostic 

16 radiologist, nuclear pharmacist, radiation safety 

17 officer, patient right advocate, Agreement State 

18 Representative, and a U.S. FDA representative 

19 giving a wide range of viewpoints to all of the 

20 issues that we discuss. 

21 Some of the topics --- next slide, 

22 please. Some of the topics addressed by the ACMUI 

23 in the last six months have been refining some of 

24 the aspects of the 10 CFR Part 35 rulemaking, issues 

25 involved with patient release following iodine-131 

26 therapy -- next slide, please --- NRC's Medical 
 6 

1 Policy Statement, the ACMUI bylaws, 

2 inconsistencies in the tables in regulations 

3 leading to problems with decommissioning 

4 germanium-68 gallium generators --- next slide, 

5 please --- medical events for all medical 

6 applications with particular attention to those 

7 involving yttrium-90 labeled microspheres, medical 

8 event databases --- next slide, please --- the 

9 physical presence requirement for gamma 

10 stereotactic radiosurgical units, safety culture 

11 and the relationship between the Nuclear Regulatory 

12 Commission and the medical community, issues 

13 concerning the supply of molybdenum-99 and the 

14 Advance Notice of the Proposed Rulemaking for 10 

15 CFR Part 20. Next slide. 

16 Our current topics, what we're 

17 currently talking about in the Committee include 

18 continuing discussions of patient release, the 

19 germanium-gallium decommissioning funding plan 

20 issue, review of the medical events, compatibility 

21 categories for medical events, continuing 

22 discussions of physical presence requirements for 

23 gamma stereotactic radiosurgery units, Part 35 

24 rulemaking status, abnormal occurrence status, 

25 radioactive seed localization guidance, patient 

26 intervention definition and guidance for handling 
 7 

1 bodies of the deceased containing yttrium-90 

2 microspheres. Also, the possibility of 

3 establishing a periodic stakeholder's topical 

4 meeting on an annual or biannual basis. 

5 The present and future of the Committee 

6 is discussing a number of issues that have come up 

7 very recently, and the number seems to be 

8 increasing. Our workload is remaining quite heavy, 

9 not overwhelming, but the issues are very 

10 interesting, and the possibility that it may be 

11 increasing is very likely, particularly if we do 

12 have stakeholder meetings. 

13 And with that, I will conclude. That's 

14 what the Committee has been doing, and is likely 

15 to be doing. And I will now turn the presentations 

16 over to Ms. Laura Weil, who is our Patient Rights 

17 Advocate. 

18 MS. WEIL: Thank you for the opportunity 

19 to talk about some aspects of patient advocacy in 

20 the context of the ACMUI. 

21 The welfare of patients is the central 

22 component of all ACMUI deliberations, and we are 

23 quite earnest about our professional and ethical 

24 responsibility to protect patients and patient's 

25 rights. 

26 Members of the ACMUI are distinguished 
 8 

1 by particular fields and expertise in medical arenas 

2 that use radiopharmaceuticals, and as the 

3 Designated Patient's Rights Advocate on the 

4 Committee, I have a dedicated responsibility to 

5 represent a constituency comprised only of 

6 patients, and I have no dual accountability to any 

7 other clinical or regulatory sphere. Next slide. 

8 So, I would like to explore briefly three 

9 broad categories of issues that have recently been 

10 discussed and mentioned by Dr. Thomadsen. Each has 

11 a significant patient advocacy component. I'll 

12 illustrate each category with specific examples. 

13 The broad issues include medical event 

14 and abnormal occurrence reporting, public health 

15 implications of regulatory decisions, and 

16 licensing-related access considerations. Each of 

17 these issues has an underlying common thread; the 

18 regulation's potential for unintentional creation 

19 of barriers to care limiting patient's access to 

20 needed medical treatment. Next slide, please. 

21 The ACMUI was asked to participate in 

22 fine tuning the definitions of medical event and 

23 abnormal occurrence. The definitions of these 

24 reportable events have to be carefully crafted so 

25 that they're used as an effective tool for improving 

26 patient safety and licensee accountability. 
 9 

1 Definitions should facilitate capture of those 

2 incidents that represent opportunities for 

3 identifying and correcting problematic issues, or 

4 processes, or individuals that cause preventable 

5 harm. 

6 Microspheres infusions and permanent 

7 implant brachytherapy have a disproportionate 

8 number of reportable events. The challenge is to 

9 develop regulatory language where licensee 

10 failures in proficiency and due diligence can be 

11 identified without unnecessarily censoring 

12 licensees whose patients experience negative 

13 unanticipated outcomes unrelated to preventable 

14 factors. 

15 Unclear regulatory language should not 

16 result in making clinicians shy away from offering 

17 patients useful therapy like microsphere infusions 

18 and permanent implant brachytherapy simply because 

19 each has a disproportionate incidence of 

20 unreasonably defined reportable events. Next 

21 slide, please. 

22 The ACMUI has been asked on several 

23 occasions to comment on the Patient Release Rule 

24 of 1997. At issue has been whether or not patient 

25 release is safe. While all members of the ACMUI 

26 believe that patient release from licensee control 
 10 

1 after administration of iodine-131 can be in the 

2 vast majority of cases a safe and cost-effective 

3 way to manage the post-treatment period. There's 

4 been much discussion, and some concern about how 

5 this is actually being managed in real practice 

6 across a wide range of treatment facilities. 

7 When the 1997 iodine-131 Patient 

8 Release Rule was put into practice, health care 

9 insurers were given solid grounds for refusing to 

10 cover even a short hospital isolation for any 

11 patient treated with iodine-131. The public health 

12 issue is to balance the tension between two 

13 competing realities; the first being the 

14 unnecessary health care resource use in hospital 

15 stays for all patients, and the second being 

16 preserving the right to a hospital stay for those 

17 few patients who are truly unable to appropriately 

18 isolate themselves during the post-treatment 

19 period. 

20 The repercussions of patient release 

21 range from the mundane to the truly sobering. 

22 There's ample anecdotal evidence of households that 

23 have been banned or fined by refuse carting and 

24 disposal services because iodine-131 patients in 

25 those homes were not adequately instructed 

26 regarding trash isolation after their treatment. 
 11 

1 Their household trash sets off radiation detector 

2 alarms when it's collected, and this causes burdens 

3 for the householder, for the carting company, and 

4 for the municipality that has to investigate the 

5 radiation alarm. 

6 This, of course, could be prevented with 

7 proper instruction prior to iodine-131 treatment. 

8 And more sobering, young children in the household 

9 of an iodine-131 patient can be exposed to radiation 

10 if the patient has not been adequately instructed 

11 about the need for isolation. 

12 These patients are predominantly women 

13 at an age when they could have children at home, 

14 and the cause of the problem, this poor instruction 

15 problem can be complex. It can be housing-related, 

16 a single bathroom in the home for use by everyone, 

17 including the patient. Bathrooms are the most 

18 significantly contaminated room in the environment 

19 of the patient who has received iodine-131. They 

20 can be language-related. The instruction for 

21 isolation was, perhaps, not provided in a language 

22 that the patient and the family easily understand, 

23 or simply that the licensee did not provide adequate 

24 instruction about the post-treatment isolation 

25 period at all, or did not provide instruction in 

26 a way that allowed the patient time to make a 
 12 

1 realistic plan for several days of isolation. 

2 There's ample anecdotal evidence that patients are 

3 not uniformly well informed about the realities of 

4 the post-treatment isolation period. Next slide, 

5 please. 

6 Creating and managing regulations to 

7 promote patient safety and licensee accountability 

8 has to be balanced against compromising a patient's 

9 right to reasonable access to treatment with 

10 radiopharmaceuticals. 

11 The ACMUI was asked to advise the NRC regarding how 

12 users of radium-223 dichloride, which is an 

13 injectable alpha emitting radiopharmaceutical, 

14 should be licensed. This was the first of 

15 potentially many injectable alpha emitters to be 

16 approved for therapeutic use. 

17 The regulatory goal is to provide 

18 licensees with appropriate guidelines for safe 

19 administration of the drug and to allow regulators 

20 to monitor such safe use with clear and enforceable 

21 standards. The ACMUI did not want to recommend 

22 something that would create unreasonable 

23 roadblocks to patient's timely access to this highly 

24 effective palliative therapy. 

25 The ultimate decision to recommend 

26 licensing radium-223 dichloride under 10 CFR Part 
 13 

1 35.300 was made with the above considerations in 

2 mind. We hoped this recommendation would facilitate 

3 safe access for patients without unduly burdensome 

4 licensing requirements for clinicians. 

5 Another recent example of ACMUI 

6 discussion involves the use of the new gallium-68 

7 drugs for diagnostic PET imaging for neuroendocrine 

8 tumors. These new gallium-68 drugs provide many 

9 benefits to patients. They provide vastly superior 

10 diagnostic images, and require only one day versus 

11 two days to image. They have a lower radiation 

12 burden, and are less expensive compared to the 

13 spectra currently in use today. 

14 They have been used for several years 

15 in Europe to manage --- to image this diverse class 

16 of neuroendocrine tumors, and the PET gallium-68 

17 drugs have been granted orphan drug status by the 

18 FDA. Currently, drug sponsors and the FDA are 

19 working together to gain approval for these 

20 important diagnostic radiopharmaceuticals. 

21 However, an NRC regulation has created an almost 

22 insurmountable and likely unintentional roadblock 

23 to broad patient access to these new diagnostic 

24 isotopes. 

25 The gallium-68 has a short half-life of 

26 68 minutes, and is produced via a small 
 14 

1 shoebox-sized generator from its parent isotope, 

2 germanium-68. The short half-life precludes the 

3 possibility of transporting the drug from central 

4 pharmacies for wider distribution and use. 

5 The problem lies in the fact that 

6 currently a decommissioning funding plan is 

7 required for the use of a 50 millicurie gallium-68 

8 generator due to the small regulatory limit of 10 

9 millicuries. The outcome of the small regulatory 

10 limit is that licensees find themselves responsible 

11 for an extremely expensive and time-consuming 

12 decommissioning funding plan requirement, to the 

13 extent that health care institutions will be 

14 reluctant to include the gallium-68 generators in 

15 their radiopharmaceutical arsenal. 

16 Our concern is that patients who suffer 

17 from neuroendocrine disorders, many of whom are 

18 children, will be in danger of being regulated to 

19 inferior and more physically burdensome 

20 alternative treatments all caused by a regulatory 

21 quirk that requires a decommissioning funding plan 

22 for a gallium-68 generator. Next slide, please. 

23 In summary, it would be safe to say that 

24 any given deliberation of the ACMUI has embedded 

25 patient advocacy components. We strive to recommend 

26 balancing regulatory imperatives and patient 
 15 

1 safety without creating unreasonable barriers to 

2 medical care. 

3 Thank you. I'll now introduce Dr. Vasken 

4 Dilsizian. 

5 DR. DILSIZIAN: Thank you, Laura. It's 

6 a pleasure to represent the Committee, and we were 

7 charged to make recommendations in answers to 

8 specific issues and questions that were brought to 

9 us by the NRC on the Advance Notice of Proposed 

10 Rulemaking for 10 CFR Part 20. Next slide, please. 

11 There were six issues that were 

12 identified by the NRC, and we'll address all six 

13 of them briefly. We will be supporting three issues, 

14 one, two, and five, and will not be supporting issues 

15 three, four, and six. Next slide, please. 

16 So briefly, issue number one is 

17 regarding updating the 10 CFR Part 20 to align with 

18 ICRP-103 methodology and terminology. The ACMUI 

19 supports replacing the terminology total effective 

20 dose equivalent with effective dose. Total 

21 effective dose equivalent is an outdated term and 

22 no longer used other than in NRC's regulatory 

23 literature. Total effective dose equivalent while 

24 similar in concept to effective dose differs largely 

25 in technical detail. It uses quality factor rather 

26 than radiation-weighting factor, and different 
 16 

1 tabulations of the tissue-weighing factor which 

2 does not include all the tissues and organs. Next 

3 slide, please. 

4 Issue number two relates to the 

5 occupational dose limit for events of the eye. The 

6 ACMUI supports changing the occupational dose limit 

7 of the lens of the eye from 15 rem to 5 rem. And 

8 this is based on recent human epidemiological 

9 studies which have suggested that reduced 

10 transparency of the lens of the eye may occur at 

11 significantly lower doses of radiation, ionizing 

12 radiation than previously estimated, which is 

13 termed radiation cataract. And this radiation 

14 cataract has actually distinct anatomical location 

15 which is posterior subcapsular region of the lens 

16 of the eye, which differs from age-related nuclear 

17 location of the cataract or in diabetic patients 

18 with cortical location, so we have a thumb print 

19 or a roadmap where there's a specific radiation 

20 cataract. Next slide, please. 

21 And the personnel exposed to byproducts 

22 material include repair or maintenance of 

23 cyclotrons. From the medical perspective, those who 

24 are involved in fluoroscopic x-ray procedures, such 

25 as intervention radiologists performing yttrium-98 

26 microsphere therapies, cardiologist performing 
 17 

1 intravascular brachytherapy, and all the 

2 associated x-ray personnel in the room. 

3 So, in a relatively busy interventional 

4 suite, the estimated annual dose to lens of the eye 

5 ranges from 4 to 8 rem. And, therefore, this is a 

6 reasonable range regarding regulation to request 

7 that the regulatory dose be down to 5 rem. Next 

8 slide, please. 

9 There are three broad categories of 

10 shielding by which this can be accomplished. Number 

11 one, protective leaded eyewear glasses which can 

12 be prescriptive eyeglasses, as well; 

13 portable/moveable transparent scatter-shielding 

14 screen. And the third, which is a more expensive 

15 option but it's very effective, is wearing a 

16 personal protection whole body suit with 1 

17 millimeter lead-equivalent acrylic face shield and 

18 apron. And all of these have been shown to 

19 effectively decrease the dose to the lens. The 

20 leaded eyewear reduces the lens dose by a factor 

21 of 5 to 10. The scatter-shield screen will reduce 

22 the lens dose by a factor of 5 to 25, and if you 

23 use both together it will reduce the dose by 25-folds 

24 or higher. 

25 What are the implications of the change 

26 from 15 rem to 5 rem? Well, this will certainly 
 18 

1 require changes in the fluoroscopic x-ray safety 

2 programs making the use of personal leaded glasses 

3 or eye protective shield, we recommend it to be 

4 mandatory for those physicians and trainees who are 

5 practicing exactly at the table with the patient. 

6 And, of course, the ancillary staff, as long as 

7 they're about 3-feet away from the fluoroscopic 

8 table, it's been shown that the radiation exposure 

9 will be 10-fold reduced to those ancillary staff. 

10 And, therefore, we would recommend that those 

11 ancillary staff be wearing eye shield, but it's not 

12 mandatory. 

13 Now, of course, if there is any procedure 

14 that has significant non-uniformity in the 

15 radiation field in terms of body versus the eye, 

16 those personnel may need to utilize eye-specific 

17 dosimeters which can be worn directly above the 

18 eyebrows with a head strap. 

19 Issue number three, that relates to 

20 limiting the dose of the embryo and fetus of a 

21 declared pregnant occupational worker. The ACMUI 

22 does not support reducing the dose to the embryo, 

23 fetus, or declared pregnant woman from 5 

24 millisieverts to 1 millisievert, or 500 millirem 

25 to 100 millirem. 

26 Unlike the data that I presented to you 
 19 

1 regarding to the dose to lens of the eye where 

2 there's plenty of scientific epidemiological data, 

3 the risk of cancer from in utero radiation exposure 

4 is a controversial subject. While the dose limit 

5 to the embryo or fetus should certainly be kept as 

6 low as reasonable, we all agree with that, there 

7 is no scientific data, however, that there's 

8 increased risk in declared pregnant occupational 

9 women with the current 500 millirem dose limit. Next 

10 slide, please. 

11 The ACMUI does not know of a source of 

12 data other than that gathered by the vendors 

13 providing individual monitoring devices. And based 

14 on our collaborative knowledge, deep effective dose 

15 equivalent measurements from individual monitoring 

16 devices assigned to these declared pregnant women 

17 remain well below 500 millirem over the gestational 

18 period, and the latest NCRP report continues to 

19 recommend dose limit of 50 rem per gestation month, 

20 which would be similar to the recommended dose of 

21 500 millirem per year. 

22 Now, I would like to add at this point 

23 that the additional potential recommendation on 

24 changing the regulatory dose to 100 millirem would 

25 be that it is equivalent to the variability of the 

26 background radiation dose that is currently present 
 20 

1 across the United States among the states. So, if 

2 we're going to have a regulatory rule, it will be 

3 tough to control that and maintain that because it 

4 would be difficult to differentiate the incremental 

5 dose of 100 millirem in a pregnant woman beyond that 

6 is already variable with the background dose. That 

7 would be extremely difficult to regulate. 

8 So, based on these findings, the other 

9 potential --- next slide. The other potential 

10 negative impacts of lowering the dose limit would 

11 be that a more restrictive limit could result in 

12 an increase in individuals choosing not to declare 

13 their pregnancy, particularly in the early 

14 gestational period in order to insure their 

15 continued employment. 

16 The other potential possibility would 

17 be that there would be non-compliance of wearing 

18 proper dosimetry in order to keep their occupational 

19 dose within the lower limit to maintain their 

20 employment. And this, of course, would result in 

21 an inappropriate bias in potentially selecting 

22 female applicants for these ionizing 

23 radiation-dependent jobs. 

24 Issue number four relates to individual 

25 protection, ALARA planning. The ACMUI does not 

26 support having specific ALARA planning and 
 21 

1 implementation requirements to 10 CFR Part 20 

2 regulations. The current Part 20 requires ALARA 

3 programs, but does not provide specific ALARA 

4 planning and implementation requirements, and so 

5 allowed licensees to design the ALARA requirement 

6 that are most appropriate for their own activities. 

7 The medical users of radioactive 

8 materials rarely experience situations where 

9 workers' doses approach regulatory limits. Many of 

10 them already utilize administrative control levels 

11 to maintain doses as low as possible. 

12 The risks --- next slide, please. The 

13 risk and safety cultures of different industries 

14 and different licensees within the same industry 

15 differ so much that providing the same 

16 compliance-based requirements on all licensees 

17 will not be effective. And, moreover, defining what 

18 may be reasonably achievable is an inherently 

19 subjective process. So, the best methodology would 

20 be to maintain the status quo and not impose any 

21 further prescriptive requirements. Next slide, 

22 please. 

23 Issue number five relates to 

24 metrication, units of radiation exposure and dose. 

25 The ACMUI does support the change to use 

26 international system of units in radiation 
 22 

1 protection regulations. The use of both 

2 international and traditional units should be used 

3 consistently throughout the regulation with the 

4 emphasis on the international unit first as a 

5 regulatory standard followed by the conventional 

6 unit in parenthesis. This should be done as a means 

7 to effect a transition to the sole use of 

8 international units in the future. This should not 

9 cause undue burden or hardship upon any licensee 

10 or class of licensees as all nations other than the 

11 United States have already accomplished this 

12 transition to the international units. Next slide, 

13 please. 

14 Issue number six relates to reporting 

15 of occupational exposure. The ACMUI does not support 

16 expanding additional categories of licensees that 

17 should be required to submit annual occupational 

18 exposure reports under 10 CFR 20.2206(a). 

19 The ACMUI does not believe that the NRC 

20 should act as the nation's repository for 

21 occupational radiation exposure data, particularly 

22 since NRC does not have regulatory authority over 

23 all ionizing radiation sources. It also does not 

24 make sense to collect national data for only one 

25 area of occupational radiation exposure 

26 considering that the more extensive exposure is from 
 23 

1 x-rays. Next slide, please. 

2 Occupational doses have low averages 

3 for medical use licensees and licensees which 

4 support them. Accordingly, many of these workers 

5 are not even assigned personal dosimetry; thus, 

6 requiring national occupational dose tracking of 

7 those radiation workers who do require 

8 individualized monitoring would lead to 

9 unrealistically high estimates of average 

10 occupational dose for medical licensees. In 

11 essence, the data would be unintentionally biased 

12 towards higher doses since most of the low-dose 

13 individuals will not be even monitoring with 

14 personal dosimetry. 

15 Moreover, occupational dose does not 

16 include doses received from background radiation, 

17 medical administration of diagnostic of 

18 therapeutic doses in these individuals, or some 

19 voluntary participation in medical research 

20 programs which will not be captured in the 

21 dosimetry. Next slide, please. 

22 And NRC does not, of course, regulate 

23 all use of radioactive materials. Most are regulated 

24 by Agreement States. If the purpose of a central 

25 database is to assess total annual occupational 

26 exposure for radiation workers, the NRC's limited 
 24 

1 regulatory authority would not make an ideal federal 

2 entity to manage such a central database. Next 

3 slide. 

4 So, in conclusion, the ACMUI recommends 

5 NRC use a similar implementation plan that was used 

6 for the latest significant change of 10 CFR Part 

7 20, 1991 where the licensee could choose to 

8 implement the regulatory change any time within a 

9 given time frame, and the ACMUI recommends a time 

10 frame of at least three years to allow 

11 implementation of procedure, training, hardware, 

12 and software changes needed to comply with the new 

13 regulatory requirements. 

14 Thank you very much for your attention, 

15 and I would like to present Dr. Palestro to present 

16 his topic on molybdenum-99. 

17 DR. PALESTRO: Thank you. In the next few 

18 minutes, I'm going to address molybdenum-99 

19 production and its impact on the medical community. 

20 Can I have the next slide, please? 

21 Molybdenum-99 is the parent of 

22 technetium-99m, and technetium-99m is the modern 

23 nuclear medicine imaging workhorse. Worldwide, 

24 technetium-99m is used in approximately 80 percent 

25 of the 30 million diagnostic nuclear medicine 

26 procedures that are performed annually. And 
 25 

1 technetium-99m studies in the United States, 

2 approximately 50,000 of these are performed on a 

3 daily basis. Next slide, please. 

4 North America, nearly 50 percent of the 

5 30 million procedures using technetium-99m 

6 annually are performed. In Europe, approximately 

7 20 to 23 percent of these procedures are performed, 

8 and Asia and the Pacific regions account for another 

9 20 to 27 percent. It is estimated that 

10 technetium-99m nuclear medicine procedures 

11 worldwide will increase by about 1 to 2 percent 

12 annually through 2020. Next slide, please. 

13 The European Union produces 

14 approximately 45 percent of the world's 

15 molybdenum-99, and consumes about 22 percent of the 

16 molybdenum-99. Canada produces about 40 percent of 

17 the world's molybdenum-99, and uses about 4 percent 

18 of the total world production. The United States, 

19 which produces no molybdenum-99, consumes nearly 

20 50 percent of the world's molybdenum-99. Next slide, 

21 please. 

22 Now, in getting from molybdenum to 99mTc 

23 and its use in nuclear medicine and for patients, 

24 there's a supply chain. It has several different 

25 components. The first component is a nuclear 

26 reactor. We have neutron bombardment of uranium 
 26 

1 target produces daughter isotopes which include 

2 molybdenum-99. Then the second component is isotope 

3 production which consists of both the extraction 

4 and purification of molybdenum-99. Third is the 

5 manufacture of the molybdenum-99 technetium-99m 

6 generator, and fourth is the distribution of these 

7 generators. And each of these components typically 

8 are organized and controlled by different 

9 organizations, different corporations. Finally, 

10 the distribution of these generators goes in some 

11 cases to hospitals, but in the United States 

12 primarily to radiopharmacies. Next slide, please. 

13 It's important for us to be cognizant 

14 of the fact that the molybdenum-technetium supply 

15 chain is fragile, and there are several reasons why 

16 it is fragile. Number one, the entire worldwide 

17 production of molybdenum-99 takes place at fewer 

18 than 10 sites, none of which are in the United 

19 States. So, the impact of any one of these sites, 

20 particularly the larger ones, going down for a 

21 protracted period of time can be quite significant, 

22 as we learned a few years ago. 

23 Complicating matters is the fact that 

24 many of these reactors, including several that I've 

25 listed here, the NRU in Canada, the HFR, the Osiris 

26 BR2 in Europe, and Safari in South Africa, which 
 27 

1 account for about 95 percent of the total world's 

2 production of molybdenum-99 are more than 45 years 

3 old. Several of these reactors are scheduled or have 

4 been scheduled for decommissioning over the next 

5 several years. And, admittedly, while the 

6 decommissioning dates have continued to be 

7 postponed, and likely will continue to be postponed 

8 for the foreseeable future, their age alone is cause 

9 for concern. They can have extensive down time, as 

10 we learned in 2008 to 2010 when the NRU in Canada, 

11 and the HFR in the Netherlands, which together 

12 account for nearly 70 percent of the world's 

13 molybdenum-99 production, were out of service for 

14 15 and 13 months respectively. 

15 Finally, the United States produces 

16 more than 90 percent of the world's highly enriched 

17 uranium. And the U.S. has decided for security 

18 reasons at some point in the not too distant future 

19 to stop exporting highly enriched uranium. Next 

20 slide, please. 

21 What are the consequences of 

22 interrupting the molybdenum-technetium-99m supply 

23 chain? Well, we had a chance to experience that and 

24 come to understand some of these problems during 

25 those interruptions of 2008 to 2010. And, 

26 ultimately, it potentially can and did wreak havoc 
 28 

1 on patient care. 

2 For example, some of the effects on 

3 diagnostic testing include postponed or cancelled 

4 studies, the use of alternative less desirable 

5 radiopharmaceuticals, the use of alternative more 

6 expensive and not necessarily more accurate 

7 procedures. The effects on patient care? Well, there 

8 were delays in diagnosis, delays in treatment, and 

9 in the United States alone from 2008 to 2012, there 

10 was nearly a 10 percent decrease in the number of 

11 nuclear medicine studies performed. Next slide, 

12 please. 

13 So, how did we cope, or how can we cope 

14 with the molybdenum-technetium supply chain 

15 interruptions? Well, what we developed, what we 

16 learned for that period of 2008 to 2010 was that 

17 the solutions were really short term, or perhaps 

18 better described as stopgap. One solution is 

19 certainly to more frequently elute the generator. 

20 The technetium activity is there, elute it, remove 

21 it from the generator, use it. That works provided 

22 you have a generator, but if the generator is not 

23 available, you can't elute it. Revised examination 

24 schedules, increasing the work day so it could elute 

25 the generator more frequently, scheduling cases on 

26 Saturdays and sometimes Sundays because the 
 29 

1 technetium is available at that time, make use of 

2 it. It certainly provides greater access to the 

3 patients in most need. And we also grouped studies 

4 together, like studies. Instead of doing a bone scan 

5 today, and a bone scan tomorrow, consolidate them 

6 all, or try to, on one day. 

7 Well, that works to some extent, but it 

8 also results in canceled studies. When studies need 

9 to be performed immediately, the referring service 

10 feels that they can't wait, they go to seek 

11 alternative studies. Next slide, please. 

12 Another option for coping with these 

13 interruptions, decrease the amount of administered 

14 activity. Give less radioactivity to each patient 

15 so that we can image more patients. And, you know, 

16 on the surface that sounds quite good, and certainly 

17 is viable. The downside is that it requires a longer 

18 imaging time to have a satisfactory or comparable 

19 image quality. And, unfortunately, the vast 

20 majority of the patients that we image are ill. 

21 They're often in pain making it difficult for them 

22 to lie still for longer time periods. 

23 In the case of the children, what is a 

24 20-minute scan turns into a 30-minute scan or a 

25 35-minute scan. And for the 20-minute scan perhaps 

26 they could lie still, for the 35-minute scan maybe 
 30 

1 now we have to go to sedation. So, there are 

2 significant ramifications to decreasing 

3 administered activity. 

4 What about alternative 

5 radiopharmaceuticals? Nuclear cardiology accounts 

6 for about 60 percent of all technetium-based 

7 studies, and during the interruptions of 2008 to 

8 2010, it wasn't uncommon to switch from 

9 technetium-based agents back to thallium-201, 

10 which is really a throwback. Thallium-201 offers 

11 inferior image quality, increased patient 

12 radiation exposure, and in some cases an increased 

13 downstream testing and increased cost. Next slide, 

14 please. 

15 There are other radiopharmaceuticals 

16 for nuclear cardiology, nitrogen-13, rubidium-82, 

17 positron emitters, excellent 

18 radiopharmaceuticals, but here we were confronted 

19 with a relatively limited number of PET imaging 

20 systems versus the conventional gamma camera SPECT 

21 imaging systems. Bone scintigraphy accounts for 

22 about 20 percent of technetium-based studies, and 

23 there certainly is an excellent alternative to the 

24 bone scan, fluorine-18. Unfortunately, again, 

25 fluorine-18 is a positron emitter so we are limited 

26 --- have to deal with limited availability. And 
 31 

1 further complicating matters is fluorine-18 is not 

2 yet reimbursable. Next slide, please. 

3 So, while these measures certainly 

4 enabled us to get by in the short run, they're not 

5 long term solutions. What, in fact, then is needed? 

6 Well, what is needed is a readily available 

7 consistent supply of molybdenum-99m so that we'll 

8 --- molybdenum-99 so the technetium-99m will be 

9 available to facilitate the performance of nuclear 

10 medicine procedures that are necessary for patient 

11 care. Next slide, please. 

12 Long-term solutions, what are they? 

13 Well, certainly, one long-term solution would be 

14 to decentralize molybdenum-99 production. As I said 

15 previously, the entire worldwide production is 

16 accomplished at fewer than 10 sites. If there were 

17 15 sites, if there 20 or 25 sites, then the impact 

18 of one, or two, or three sites going down at any 

19 given time would be of far less magnitude than what 

20 we experienced in 2008 to 2010. For a lot of reasons, 

21 that's probably not likely to happen. 

22 I think a more realistic and probably 

23 a better solution, certainly for the United States, 

24 is to develop a reliable domestic supply of 

25 molybdenum-99. At least under these circumstances 

26 we will be in control of our own destiny. Next slide, 
 32 

1 please. 

2 At the moment, there are two companies 

3 that are seeking or in the process, I should say, 

4 of developing molybdenum-99. One is NorthStar 

5 Medical Technologies which makes use of a neutron 

6 capture technology. They had planned to be 

7 operational in 2015, although, it looks like 2016 

8 is probably a better estimate of when they might 

9 be operational. Initially, they would anticipate 

10 being able to provide about 5 percent of the United 

11 States molybdenum-99 needs. When they are fully 

12 operational at some time in the future they expect 

13 to supply about 50 percent of our country's needs. 

14 Shine Medical Technologies is the other 

15 company. They make use of a low enriched uranium 

16 technology, and they say that when they are fully 

17 operational they will be able to supply perhaps as 

18 much as one-third of the world's molybdenum-99 

19 needs. They originally had hoped to be operational 

20 by the end of 2017, but now it appears that they're 

21 not likely to be operational until sometime in about 

22 mid-2018. 

23 So, in summary, we have made some strides 

24 towards coping with interruptions in the 

25 molybdenum-99 supply, but we still have a way to 

26 go. Thank you, and now I'll turn the session over 
 33 

1 to Mr. Francis Costello. 

2 MR. COSTELLO: Thank you. As Chairman 

3 Burns mentioned, both he and I had a previous NRC 

4 career, and mine was for 30-1/2 years, and during 

5 that time I never had the opportunity to brief the 

6 Commission, so I'm very honored to be able to be 

7 here today. 

8 About a year ago, you know, I work in 

9 Pennsylvania, we had an event involving 

10 microspheres where they were shunting to the GI 

11 tract. And we'd never seen one of those events 

12 before, so I did a little literature research and 

13 looked in EDMED and another Agreement State, Ohio, 

14 had a couple of events like that. And then I looked 

15 further in the literature, which indicate that 

16 actually this was a recognized risk of the 

17 treatment, and might be expected to happen a couple 

18 of percent of the time. 

19 So, I talked to some of the RSOs at our 

20 larger institutions, mostly in Philadelphia, and 

21 they indicated that it may very well be that this 

22 was -- it may be that many of the uses were not 

23 consider to be medical event then -- if they did 

24 everything right themselves. And despite that, the 

25 spheres went to the GI tract. So, having just been 

26 appointed to the ACMUI, I brought it up at the ACMUI 
 34 

1 spring meeting, and they set up a subcommittee to 

2 look into this. So, I'm reporting back to you today 

3 as to what the subcommittee did, and make a few 

4 comments on what the implications are. Next slide, 

5 please. 

6 A little bit about the treatment itself. 

7 For the most part, these treatments are done as a 

8 palliative treatment. There's some evidence it can 

9 improve survival, and it perhaps in fortunate cases 

10 it could enable the patient to become ready for a 

11 transplant. But mostly, this is done as a palliative 

12 treatment. Next slide, please. 

13 The procedure, and there's an image I'll 

14 show you in a second, the microspheres go through 

15 a catheter, go to the hepatic artery, the branches, 

16 and the microspheres themselves are too large to 

17 pass through the capillaries and become permanently 

18 implanted in the tumor, and they then irradiate the 

19 tumor with a therapeutic dose. Next slide, please. 

20 You can see an image of this there, and 

21 if you note, in a couple of places there is 

22 blockages, and those are there to prevent the 

23 microspheres from going to places they shouldn't 

24 go; prevent them to be shunting to the lung, and 

25 prevent shunting to the GI tract. So, there's 

26 mapping that's done in advance of the treatment to 
 35 

1 make --- to do the very best they can to make sure 

2 that these spheres only go to the liver and don't 

3 go to the GI, or go to the lung. Next slide, please. 

4 So, each patient must meet strict 

5 selection criteria. And each procedure is 

6 meticulously individualized for the patient to make 

7 sure that the right dose is given, of course, and 

8 to make sure that the spheres will not go to places 

9 they shouldn't go. And the idea is to eliminate or 

10 minimize the known risk of activity deposit, 

11 non-target tissues, particularly into the lung, and 

12 into the GI tract, which is what we had in 

13 Pennsylvania, and it also happened in Ohio. Next 

14 slide, please. 

15 So, a subcommittee was formed at the 

16 spring ACMUI meeting to determine well, what 

17 conditions should be a reportable medical event, 

18 because it was apparent that there are practitioners 

19 who are doing this, and because they put the spheres 

20 exactly where they wanted them to go and they blocked 

21 the vessels off the best they could, may not have 

22 been reporting these because the procedure had gone 

23 well despite that the spheres wound up, perhaps, 

24 in the GI tract. So, the Committee was looking into 

25 well, what can do about that? What's the right thing, 

26 and what's the right thing for the guidance to be 
 36 

1 done? As I'm sure you know, this treatment is done 

2 under 35.1000, so most of the requirements are found 

3 in the guidance which is on the website which has 

4 been changed quite a few times since the first time 

5 this was placed under 35.1000. Next slide, please. 

6 So, our charge was recommendations for 

7 relevant changes to the guidance. And the guidance, 

8 most recent guidance was in 2012. next slide, 

9 please. 

10 However, we were also given an expanded 

11 charge at the discretion of the subcommittee, we 

12 could determine whether additional medical event 

13 issues related to --- unrelated to GI deposition 

14 also require considerations. And we were to offer 

15 specific recommendations to the Staff on related 

16 regulatory guide changes. Next slide, please. 

17 So, the Committee met on this over 

18 several months over the summer of 2014, and we voted 

19 unanimously that the current guidance needs to be 

20 modified in order to align with the new 

21 characteristics of Y-90 microsphere brachytherapy. 

22 The advances and improvements that have occurred 

23 over time to basically decrease the likelihood of 

24 these spheres winding in non-target areas. And, 

25 actually, to reflect the current medical practice 

26 of authorized users and medical teams across the 
 37 

1 country. Next slide, please. 

2 The conclusion was, basically, that the 

3 most appropriate metric for regulatory purposes is 

4 what was the prescribed activity in the directive, 

5 and what was the actual activity infused into the 

6 patient? The medical event report criteria should 

7 be based on a readily determined difference between 

8 the prescribed activity in a written directive and 

9 the actual activity put into the patient. Next 

10 slide, please. 

11 You may recall, there's some similarity 

12 here between what we did in permanent brachytherapy, 

13 the same issue came up there. Specification of an 

14 acceptable GI tract and lung dose in the written 

15 directive should not be required because, 

16 basically, the goal here is that there not be 

17 shunting. Not that we're trying to set an acceptable 

18 level of shunting, but with proper mapping and 

19 proper blocking of vessels, that there will not be 

20 shunting, or significant shunting to the GI tract, 

21 or to the lung. So, the total treatment activity 

22 to be administered should require compliance 

23 measures for organs and tissues other than the 

24 treatment site. 

25 A written --- a medical event in this 

26 case would be if there's a difference between the 
 38 

1 actual infused activity and the activity written 

2 in the written directive. That would be the goal; 

3 except, there are some cases where stasis occurs, 

4 and it's not possible to safely infuse any more 

5 activity, and that then simply becomes a new 

6 prescribed activity. Except in the case of stasis, 

7 you compare the prescribed activity to the infused 

8 activity, and if it differs by more than 20 percent, 

9 that would be a medical event. 

10 We recommended that the Staff 

11 incorporate these considerations into the 

12 guidance, and that they share this with the 

13 Agreement States and the licensees so they can 

14 implement it. Last fall, at the fall meeting, we 

15 provided the recommendations to the Staff, and Staff 

16 currently has them under consideration. I expect 

17 we'll be hearing from them at our next meeting. 

18 A few points I would like to make about 

19 this. As I mentioned before, this modality is 

20 regulated under 35.1000, which gives us the 

21 flexibility of essentially changing the 

22 requirement without a rule change. I would also 

23 point out that the --- it shows how operational 

24 experience coming from Agreement States, Ohio and 

25 Pennsylvania, can be of great benefit to the NRC, 

26 to the Staff. You know, most of the licensees, those 
 39 

1 medical licensees now are regulated by Agreement 

2 States, and getting that operational experience to 

3 the NRC is of great value to them. 

4 In addition, the ACMUI's advice to the 

5 Staff on an issue like this is a frequent and 

6 integral part of the process for developing 

7 guidance, and it provides yet another example of 

8 the value-added by the ACMUI. Thank you. 

9 CHAIRMAN BURNS: Thank you, Mr. 

10 Costello. And with that, I think that's it, and we'll 

11 begin with Commissioners question. Commissioner 

12 Ostendorff. 

13 COMMISSIONER OSTENDORFF: Thank you, 

14 Chairman, and thank you all for being here. 

15 Congratulations. 

16 DR. THOMADSEN: Thank you. 

17 COMMISSIONER OSTENDORFF: And I just 

18 think --- I've been here --- I guess I'm the 

19 second-longest serving Commissioner after 

20 Commissioner Svinicki, but I know that after five 

21 years of being at these meetings, I continue to be 

22 amazed at what I learn and just the highlights of 

23 value that you provide to the NRC when it comes to 

24 the intersection between what we regulate and how 

25 medicine is practiced in this country, so I'm just 

26 very grateful for what all of you do. 
 40 

1 Dr. Thomadsen, let me start off with you, 

2 please. On your Slide 7 you talk about some of the 

3 topics in your overview, and I found that very 

4 helpful. But could you just comment maybe in a little 

5 more detail, the bullet on the relationship between 

6 the NRC and the medical community? Are there any 

7 particular concerns there, or any high-level points 

8 you'd like to make? 

9 DR. THOMADSEN: Yes. We've talked about 

10 that at a previous Commissioner's briefing, that 

11 the relation between the Commission's Staff and the 

12 facilities is very critical to try to improve the 

13 safety at those facilities. The punitive effect of 

14 some of the inspections and the way that the 

15 inspectors may characterize problems that are found 

16 can itself provide a chilling effect on the 

17 reporting of problems from a facility. And sometimes 

18 this may be intentional, and sometimes it may not. 

19 It may be that the facility may understand some 

20 things about problems they have, but they just don't 

21 want to share for fear that they may be punished 

22 in some way. 

23 So, the safety culture that the NRC 

24 suggests for facilities to try to be open and 

25 non-punitive also could be beneficial to apply for 

26 the NRC working with the facilities, the goal being 
 41 

1 to improve safety, not necessarily to punish those 

2 who have accidents and commit errors. 

3 COMMISSIONER OSTENDORFF: In your 

4 communications between the Committee and the NRC 

5 Staff, does our Staff have the benefit of the 

6 knowledge of some of these specific examples where 

7 you believe there's been a chilling effect, or a 

8 punitive approach from the eyes of the inspected 

9 facility? 

10 DR. THOMADSEN: At the briefing last 

11 time, I did use an example that was presented by 

12 an NRC Staff person at the Health Physics Society 

13 meeting last year, not this --- the one that was 

14 in Madison, where the inspect --- or the person 

15 reporting on the inspection was talking about the 

16 chilling effect at the institution of the workers 

17 who did not want to report things that would make 

18 their facility look bad, and made the assumption 

19 that that was due to the managerial policy; 

20 although, that was not clear in the presentation. 

21 What was clear in the presentation was that the NRC's 

22 Staff during the inspection and the report was 

23 definitely making statements about the facility 

24 that possibly could exacerbate any chilling effect 

25 that there might be at the facility. 

26 COMMISSIONER OSTENDORFF: Okay, thank 
 42 

1 you. 

2 DR. THOMADSEN: You're welcome. 

3 COMMISSIONER OSTENDORFF: I'm going to 

4 shift now to Mr. Costello, but I'm kind of looking 

5 at the very last slide you have, and the last bullet 

6 about, you know, the example, the benefit of ACMUI's 

7 input into the Staff. I thought that was really an 

8 effective summary of your presentation. 

9 I guess one thing that I wanted to ask 

10 you about, but others may have an opinion here to 

11 --- and you'll have a chance to provide that. You 

12 know, as a regulatory body we, obviously, deal with 

13 rulemaking under the Administrative Procedures 

14 Act. There's a very somewhat bureaucratic process 

15 we go through to look at regulatory issues, and even 

16 with respect to promulgation of guidance. And I was 

17 just trying to think about the yttrium-90 

18 microsphere piece and the notion of palliative care 

19 is why that's being administered in many of the cases 

20 of treatment. And do you feel like our system is 

21 sufficiently responsive time-wise to incorporate 

22 this type of feedback, and to change the guidance, 

23 or do you have any perspective on that having worked 

24 at the NRC, and being in your current position? I 

25 worry about, you know, because medicine --- I know 

26 the practice of medicine, this as a lay person, 
 43 

1 changes every day. And practices, it's a very 

2 dynamic environment, and so --- but we're not 

3 necessarily set up to be as dynamic as the practice 

4 of medicine is. Do you want to comment on that? 

5 MR. COSTELLO: Absolutely, sir. 

6 Modalities are covered by 35.1000, enables the NRC 

7 to be fairly nimble in changing it as they become 

8 more knowledgeable what's going on out there in the 

9 community. And this is a very good example here. 

10 I mean, the Staff can change the guidance in the 

11 website fairly easily, and I think you'll find all 

12 the Agreement States pretty much follow what's on 

13 the websites. 

14 Changes, however, that require 

15 regulatory changes. We talked about the 

16 germanium-gallium generator, for example, changes 

17 that would seem very simple can take an inordinate 

18 amount of time because the rulemaking process is 

19 what it is. So, I'll say that the -- with regard 

20 to things in 35.1000, I think the NRC should be proud 

21 how quickly it can change the guidance and improve 

22 things. With regard to things that are in black 

23 letter regulation, it's much slower, much more 

24 difficult. 

25 COMMISSIONER OSTENDORFF: Do you see 

26 --- you know, from your experience over your career, 
 44 

1 do you have any suggestions on how we might be able 

2 to be a bit more responsive in this area? Again, 

3 noting that this is the practice of medicine, as 

4 opposed to perhaps some other topical areas we 

5 regulate? 

6 DR. THOMADSEN: Yes. There's a downside 

7 of 35.1000, and the downside, it doesn't have the 

8 public comment, the public input that you have for 

9 regulations. There's a reason why rulemaking takes 

10 as long as it does, because more opportunity for 

11 the public to get involved in the process, and I 

12 understand that. 

13 In addition, things under 35.1000 are 

14 supposedly there temporarily. And the goal of 

15 35.1000 was to --- for new modalities until the 

16 Agency gets experience to regulate them that way, 

17 that perhaps later are incorporated in the 

18 regulations. 

19 In all honesty, I have never understood 

20 why the simplest rulemaking takes as long as it does. 

21 You will know way better than I do. I imagine you 

22 must be as frustrated as many people are that the 

23 simplest rulemaking can take years. 

24 My only advice would be if there's some 

25 way to, you know, make things go through the direct 

26 rulemaking process more simply for things that are 
 45 

1 non-controversial. Again, the example of the 

2 germanium decommissioning requirements, changing 

3 them, there would be no --- no one would complain. 

4 It's an obvious change that one would want to make, 

5 if you knew the situation. But when one talks about 

6 it, it talks well, this could take years. It is 

7 incomprehensible to the outside. States are slow, 

8 but not that slow. 

9 COMMISSIONER OSTENDORFF: Okay. I'm 

10 going to allow our Patient Rights Advocate. Perhaps, 

11 I think you maybe wanted to say something, Laura? 

12 MS. WEIL: I just --- I think Mr. 

13 Costello has said it well. The time lag to be able 

14 to make changes that would benefit patients and 

15 clinicians, it's just such an unwieldy process. And 

16 there must be something that can be done to give 

17 relief in those situations where there's clearly 

18 a need, and no downside. 

19 MR. COSTELLO: Can I make one more 

20 comment on that? 

21 COMMISSIONER OSTENDORFF: Yes. 

22 MR. COSTELLO: In 2005, the Commission 

23 which did not include anyone here, recommended that 

24 the requirements for permanent brachytherapy 

25 change from a dose-based rule to an activity-based 

26 rule. This is in 2005. It is now 2015, and the current 
 46 

1 requirement for permanent brachytherapy is a 

2 dose-based rule. And the Chairman and I discussed 

3 this over breakfast this morning, the U.S. 

4 Constitution was written faster than that. Thank 

5 you. 

6 COMMISSIONER OSTENDORFF: Thank you for 

7 that helpful example. Thank you all. 

8 CHAIRMAN BURNS: Commissioner Baran. 

9 COMMISSIONER BARAN: Well, thanks for 

10 being here, and to all of you for your service on 

11 the Advisory Committee. 

12 Just to follow-up on the yttrium-90 

13 microsphere issue. I wanted to get a better sense 

14 of how common is it that non-targeted organs are 

15 affected, and how avoidable is that? Is it something 

16 that's just unavoidable in certain cases, or are 

17 there practices that can improve the issue? 

18 MR. COSTELLO: The medical practice has 

19 learned a lot over the last seven or eight years, 

20 in terms of doing the mapping in advance to prevent 

21 these spheres from going to the lung, or going to 

22 the GI tract. This is a very personalized treatment, 

23 but sometimes the body can resist what you're trying 

24 to do. And it could create new pathways after you've 

25 blocked the previous pathways. 

26 I don't think we know how common it is. 
 47 

1 It is rarely reported, which is the first thing that 

2 called it to my attention. It happened in 

3 Pennsylvania, it happened in Ohio, looked at the 

4 literature and you look at the package insert on 

5 this and it indicates this is an expected, you know, 

6 risk of this procedure. And it's hardly ever 

7 reported, I think because the practitioners who when 

8 they do everything properly to the best of their 

9 knowledge, don't see this as a medical event. 

10 I really do not know how often this 

11 happens. I know that it's rarely reported in 

12 Pennsylvania. In the eight years we've been an 

13 Agreement State, I think it happened once, but I 

14 think some states have never had it reported. But 

15 you read the literature, it should happen a certain 

16 number of times. 

17 DR. DILSIZIAN: Could I add to that? 

18 COMMISSIONER BARAN: Please. 

19 DR. DILSIZIAN: We do a lot of yttrium-90 

20 therapies at the University of Maryland, and the 

21 two areas is the gastric reflux, which the physician 

22 should be able to coil the artery so that they avoid 

23 the reflux. And it's rare, it's very rare for us. 

24 We do several of these a week, and we're one of the 

25 largest centers that do these therapies. 

26 Regarding the shunt, the lung shunt that 
 48 

1 we're talking about, it can't be prevented by 

2 coiling the arteries. The shunt itself is a 

3 physiological shunt. The tumor itself has AV 

4 malformation so you give the microspheres, it just 

5 goes to the lung, and we can understand that before 

6 the therapy by giving MAAs and you calculate what 

7 the percent shunt is to the lung. And, accordingly, 

8 you give lower dose to prevent subsequent 

9 radiation-induced pulmonary fibrosis, if you will. 

10 And so the two --- I don't want to mix those two 

11 up. 

12 The gastric reflux is something that you 

13 can prevent by coiling. The lung shunt is a 

14 physiological shunt induced by the tumor, which you 

15 can assess ahead of time, and then change your 

16 dosimetry accordingly. Does that help? 

17 COMMISSIONER BARAN: That does help. And 

18 just so that I have a better understanding of this, 

19 so tie that a little bit to the guidance and what 

20 that looks like now. So, walk us through a little 

21 bit what's the essential concern with the current 

22 guidance? Is it unclear, or is it implementation 

23 too difficult, or is there another issue there? 

24 MR. COSTELLO: I think they think that 

25 it's clear but it's not good. 

26 COMMISSIONER BARAN: Okay. 
 49 

1 MR. COSTELLO: The guidance would ask 

2 you to estimate the dose to the GI tract. And, 

3 basically, the medical team is trying to prevent 

4 any dose to the GI tract. It's not a matter of what's 

5 acceptable. The idea is to have none. And as you 

6 indicate, as far as the lung goes, I believe there's 

7 some situations where via the mapping, if they think 

8 the dose to the lung is too high, they reduce the 

9 dose along to the treatment. Okay? I think I've 

10 answered the question. 

11 COMMISSIONER BARAN: Okay. Did you want 

12 to add anything, Dr. Dilsizian? 

13 DR. DILSIZIAN: No, that's fine. 

14 COMMISSIONER BARAN: Okay. And I take it 

15 most of you were on the Subcommittee that looked 

16 at this issue. Ms. Weil, were you on the 

17 Subcommittee, also, or no? Do you have a view on 

18 this? 

19 MS. WEIL: Well, I think, you know, from 

20 a patient's perspective, I think the problem is, 

21 is that this is a therapy which is not I would say 

22 common, but it is of great value, and is a last resort 

23 to folks who have these intractable tumors, and who 

24 perhaps need to just survive while they're on the 

25 transplant list to get something curative. But 

26 institutions become less and less willing to provide 
 50 

1 this particular therapy because they get reported, 

2 because there is a high incidence of reportable 

3 events associated with microsphere infusions. And 

4 that's --- you know, it creates something that is 

5 not beneficial to patients when the reportable 

6 events impede treatment in a way that isn't related 

7 to protecting patients, because it should be patient 

8 protection, it should be to identify preventable 

9 problems, and that's kind of not how it's playing 

10 out. 

11 COMMISSIONER BARAN: So, let me ask you 

12 this, and this is for anyone who wants to weigh into 

13 this. I mean, what's your sense of whether there 

14 would be any controversial about changing the 

15 guidance in this way? Is this something that there 

16 are folks who are going to be really concerned about 

17 this, or is this one of those cases where there's 

18 going to be kind of universal agreement that this 

19 is a good idea? 

20 DR. THOMADSEN: I'll take a stab at that 

21 one. 

22 COMMISSIONER BARAN: Okay. 

23 DR. THOMADSEN: And I don't think so. I 

24 think this is --- this would be a change that would 

25 not be controversial, and particularly the people 

26 who do the procedure understand that this is a 
 51 

1 problem with physiology. It's not a problem with 

2 what they do, and so they would be in favor of it. 

3 The Patient Advocate, as you've just heard, would 

4 not want to see this limit the number of places that 

5 could do this just because of fear of having to 

6 report an event. The number of occasions in which 

7 this is a --- has detriment to the patient is few. 

8 There are some, and it is a known toxicity of the 

9 procedure. Being a known toxicity and one that is 

10 just part of having the procedure done, there seems 

11 little reason to call that an event. 

12 COMMISSIONER BARAN: Talking more about 

13 a side effect. 

14 DR. THOMADSEN: Yes. 

15 COMMISSIONER BARAN: A known side 

16 effect. 

17 DR. THOMADSEN: Yes. I'm sorry. The 

18 terminology that most lay people would have would 

19 be side effect. 

20 COMMISSIONER BARAN: Which I --- 

21 DR. THOMADSEN: Right, we use toxicity. 

22 Sorry. 

23 COMMISSIONER BARAN: Right. No, that's 

24 fine. Anything else on that topic before we turn 

25 to someone else? Yes? 

26 DR. PALESTRO: Yes. We do a fair number 
 52 

1 of these procedures, approximately 100 per year, 

2 and I would just echo Dr. Thomadsen's comments about 

3 a lack of opposition to changing the guidance. 

4 One of the big issues is there's no 

5 reliable way to accurately determine the dose to 

6 the gastrointestinal tract given current 

7 techniques that we have. And while I can't quote 

8 you the frequency with which these side effects 

9 occur, I think there's ample documentation in the 

10 literature, and certainly our own personal 

11 experience that the more of these that are done, 

12 the more experience that one has, the fewer --- the 

13 lower the frequency of these sorts of events. 

14 We had one or two cases early on, and 

15 have not had any cases of GI toxicity over the past 

16 couple of years. So at our institution, at least, 

17 it would be well under 1 percent. 

18 COMMISSIONER BARAN: Okay, thank you. 

19 MR. COSTELLO: Just one thing. 

20 COMMISSIONER BARAN: Yes. 

21 MR. COSTELLO: The one thing I would 

22 remind you, of course, is we have not heard back 

23 from the Staff yet. These are recommendations that 

24 we gave the Staff at the fall meeting, and I'm hoping 

25 to hear the Staff's response to this at next fall's 

26 meeting. 
 53 

1 COMMISSIONER BARAN: Okay. Maybe we 

2 could turn to the proposed changes to Part 20 for 

3 just a minute, or for the last couple of minutes 

4 of my time. Thank you for your comments on that. 

5 Can you talk a little bit more about how 

6 the Advisory Committee weighed the pros and cons 

7 of the proposed change to the occupational dose 

8 limit for the lens of the eye from 15 rem to 5 rem? 

9 DR. DILSIZIAN: Yes. Thanks. The two 

10 major areas is that there was significant 

11 epidemiological scientific data to suggest that 

12 radiation does induce cataract, number one. And that 

13 there was a fingerprint area of the lens of the eye 

14 posterior subcapsular which was related to that. 

15 The next thing we did is to say okay, 

16 now that we do know. Now, unlike other aspects of 

17 radiation, fortunately, cataracts are easily 

18 replaceable with another lens surgically. 

19 Obviously, we need to work on the prevention rather 

20 than the therapy aspect of it. 

21 The next was the data on what is a busy 

22 interventional laboratory, what was the annual 

23 exposure in those individuals? And I provided the 

24 data, it was before 4 and 8 rem. So, that's assuming 

25 that we're not doing all these protective measures. 

26 Now, I would admit that most radiologists and 
 54 

1 cardiologists are wearing lead eyeglasses, but I'm 

2 not sure --- I don't think that they're wearing lead 

3 eyeglasses plus the shield, so you can actually 

4 reduce by 25-folds if you do the two combinations. 

5 So, given that the range was within that 5 rem, it 

6 wasn't too far away, we felt that it would be 

7 important for us to not just recommend but mandate 

8 prevention for cataract at these folks who are at 

9 the table, and make it a recommendation for those 

10 who are in the room, but 3-feet away from the table. 

11 COMMISSIONER BARAN: And it sounds like 

12 the steps you take there are actually pretty 

13 straightforward, if it's just kind of the glasses 

14 and stand behind a screen. 

15 DR. DILSIZIAN: Yes. And, again, some of 

16 these are already in place in that sense. The shield 

17 in the CAT lab, it's there. The glasses some people 

18 use. It's just that it's not used C-it would be nicer 

19 to make the recommendation more firm rather than 

20 voluntarily, if you will. 

21 COMMISSIONER BARAN: Okay, thank you. 

22 Thanks, again. 

23 CHAIRMAN BURNS: Thank you all, again, 

24 for your presentations. Good to get the briefings 

25 on the various aspects of the work of the Committee. 

26 One question I have, maybe start going 
 55 

1 back to this area that Mr. Costello and Ms. Weil 

2 were talking about, and anyone can sort of respond 

3 to this. But, I mean, I remember --- I mean, I 

4 started to work here at the time when we called these 

5 medical events misadministrations. And I forget 

6 and, Frank, you'll have to remind me when that rule 

7 change, I think that may have been in the '90s. And 

8 I understand, and I appreciate that, but --- and 

9 this is maybe in part --- it's not really a 

10 rhetorical question, but the question, what's the 

11 effect --- and maybe those from the medical 

12 --- what's the effect of identifying something as 

13 a reportable event? And when I started saying is 

14 not from the standpoint of the NRC, because I think 

15 I understand from the NRC, but under --- I think 

16 behind your comments there's a question of there's 

17 an impact of labeling something as a reportable 

18 event. So, I'd appreciate actually anyone's 

19 comments or reflections on that. 

20 MS. WEIL: I think even a little further 

21 upstream what's the purpose of collecting this data? 

22 And the purpose of the collection should be to 

23 improve patient safety, to improve clinical 

24 outcomes, but that's not how it works out, 

25 necessarily, because the definitions of these 

26 reportable events does not --- it doesn't 
 56 

1 necessarily relate to something that can be 

2 corrected. And it's those two pots that we have to 

3 reconcile, the preventable stuff, and the 

4 unpreventable stuff. 

5 Certainly, reporting preventable stuff 

6 and fixing the procedures and the processes, the 

7 institutional processes that lead to them would be 

8 a wonderful outcome, but the unpreventable stuff 

9 is different, and those need to be teased apart. 

10 CHAIRMAN BURNS: Yes, Frank? 

11 MR. COSTELLO: I can't tell you how many 

12 times in speaking to licensees either individually 

13 or sometimes as a group, I will say medical events 

14 are not violations. I mean, sometimes we follow-up 

15 on a medical event, it's a clear inspection. And 

16 we actually will praise the licensee for having 

17 identified and take corrective actions for this 

18 medical event. However, I recognize that --- and 

19 they will tell me that sometimes they think that 

20 I'm naive; that these things are public, that their 

21 management is unhappy, patients may hear about it. 

22 You may recall the fellow at the VA a number of years 

23 ago, and they'll tell me stories of other inspectors 

24 or other regulatory agencies other than 

25 Pennsylvania coming down very hard on licensees for 

26 having reported a medical event even though they 
 57 

1 may have done everything right. 

2 It's up to us, speaking now as a 

3 regulator, it's up to us to treat these things as 

4 they're supposed to be treated; that the simple 

5 reporting of them is something as a licensee is a 

6 good thing. They identified it, and reported it, 

7 and took corrective actions. There may be times 

8 where the causes of something is another story, but 

9 yes, I think there are licensees who when told that 

10 a medical event is not a violation think that the 

11 person telling them that is naive. They don't 

12 understand the real environment that these people 

13 work in. 

14 CHAIRMAN BURNS: Okay. Anyone else? Dr. 

15 Dilsizian, I've got a couple of questions on the 

16 proposed Part 20. Actually, I saw the one 

17 recommendation with respect to the conversion to 

18 international units sort of somewhat bemused 

19 because I just came from OECD Nuclear Energy Agency 

20 and my colleagues in radiation protection were very 

21 amused at the Americans and their practices. I said 

22 well, I'm here now. I said I'm here for legal advice, 

23 not for whatever, but anyway, so it's interesting. 

24 Is there perhaps --- is there a 

25 resistance, perhaps, other than it's always 

26 difficult, you know, making --- you know, 
 58 

1 relabeling things or something like that. Where do 

2 you see the potential resistance to that 

3 recommendation? 

4 DR. DILSIZIAN: I suspect it won't 

5 C-there won't be a lot of resistance. It's just, 

6 you know, it's human nature. You're used to certain 

7 terminologies, you're resistant of change. But I 

8 guess in our investigation we found out that a lot 

9 of the --- even in the United States, a lot of these 

10 treating doses have already switched to 

11 international doses. 

12 CHAIRMAN BURNS: Okay. 

13 DR. DILSIZIAN: So, there is already a 

14 large adaptation when it comes to exporting and 

15 importing. And all that we need to do now is within 

16 the United States kind of move that into that 

17 direction. 

18 I just think that it's just a matter of 

19 a few years, a period of time just getting used to 

20 the reporting both, and at some point to just give 

21 up. 

22 CHAIRMAN BURNS: Okay. As I say, I was 

23 constantly sort of poked by colleagues at NEA over 

24 this issue. One other thing to make sure I understand 

25 the question on ALARA, or ALARA programs. I take 

26 it, and I haven't looked at the particular 
 59 

1 recommendations, ANPR, in particular. But I take 

2 it the concern is that the description that would 

3 be --- there are more precise guidelines or criteria 

4 for particular ALARA programs. Is it that the nature 

5 of it? 

6 DR. DILSIZIAN: Yes, because there's 

7 such different applications with this equipment, 

8 machinery versus medical use, to have one 

9 prescription which is relatively subjective to kind 

10 of guide all of them would be difficult. And I also 

11 understand that the ones that we would be concerned 

12 with that would approach the ALARA limit, the large 

13 machines are actually under Agreement States more 

14 than under NRC's, so it seems like we're not --- we 

15 don't have the jurisdiction to even make that 

16 happen, even if we were to prescribe them, 

17 specifically. 

18 MR. COSTELLO: If I may. Most of 

19 occupational dose in medical institutions result 

20 from x-rays. Even the lens of the eye is from x-rays. 

21 The amount of dose from byproduct material at 

22 medical institutions is pretty near ALARA right now. 

23 To me, it's fixing a problem that's not there, at 

24 least in the medical arena, anyway. 

25 CHAIRMAN BURNS: Thanks. Dr. Palestro, 

26 I was interested in the comments in terms of the 
 60 

1 supply of isotopes. I know this is another issue 

2 that's gotten the attention of the international 

3 community, been providing legal support at NEA for 

4 joint declaration on the supply. But as sort of a 

5 bottom line given what you showed, I thought it was 

6 a very interesting chart in terms of production and 

7 use, or production and consumption. Ultimately, it 

8 looks like biggest solution in terms of long term 

9 is some sort of, you know, isotope producer in the 

10 United States, or the ability to do that. Would you 

11 agree? 

12 DR. PALESTRO: No, absolutely, because 

13 as I had said, it would allow us to control our own 

14 destiny, that we're not dependent on outside sources 

15 for the molybdenum. 

16 CHAIRMAN BURNS: Yes. At this point as 

17 you note, that there are significantly older 

18 facilities. And I guess NRU they've extended for 

19 another three years. I think originally it was 

20 supposed to be, they had announced before, shut down 

21 this year and have extended for three years. And 

22 I know they have the same issue in terms of the 

23 reactors in Europe themselves in terms of it. So, 

24 the bottom line, you say there is a lot of work in 

25 terms of sort of international cooperation on 

26 improving the isotope production of --- I think 
 61 

1 it's, in effect, the full cost --- and one of the 

2 issues I think internationally has been this issue 

3 of full cost recovery, and all. 

4 DR. PALESTRO: Yes. 

5 CHAIRMAN BURNS: But, ultimately, it's 

6 about facilities that are able to produce the 

7 isotope. Okay. Well, thank you very much. 

8 Commissioner Svinicki. 

9 COMMISSIONER SVINICKI: Good morning, 

10 and thank you all. I have had the opportunity for 

11 a number of years now to participate in the 

12 Commission's engagement with your Committee, and 

13 I thank all of you and your colleagues who aren't 

14 maybe here in the room today for the work that you 

15 do. 

16 It's curious to me, I look around the 

17 audience today, and I was thinking to myself, I think 

18 it's at the end of this month our Commission will 

19 hold a meeting on our Fukushima activities, which 

20 are very important. I predict that there will be 

21 almost no empty seats in the room and, yet, for 

22 something that affects all of us, and certainly if 

23 you include our close loved ones on a day to day 

24 basis, we do not have as many people present. And 

25 I hope you don't take it as a sign that there isn't 

26 a strong interest, and I'll go beyond that to say 
 62 

1 a very essential quality to having the kind of 

2 medical and patient advocacy and Agreement State 

3 input that the Committee's structure provides to 

4 us. 

5 All matters related to nuclear medicine 

6 with which I've been involved in time as a 

7 Commissioner, I approach as very, very perilous 

8 matters because of the fact that there is a real 

9 life safety patient outcome element here that I 

10 think given the strong defense-in-depth in many 

11 other aspects of our regulatory structure are not 

12 as keenly present as they are in the medical uses 

13 of nuclear technologies. 

14 So, I think that our overall charter to 

15 ourselves as the Nuclear Regulatory Commission not 

16 to unnecessarily impede, and frustrate, and 

17 obstruct the practice of medicine regarding these 

18 modalities, and the diagnostic and therapeutic 

19 techniques is something that over the course of the 

20 years that I've been on the Commission, I think to 

21 a person, all members of our Commission have taken 

22 very, very seriously. And I think I'll just state 

23 that my sense from the NRC Staff is that they have 

24 a similar posture on these issues because very 

25 consciously we do not attempt to replicate the types 

26 of practitioner and patient advocacy expertise that 
 63 

1 the Committee provides. 

2 So, I'll just react to a few things. I 

3 might have a couple of questions, but since this 

4 has been a multi-year dialogue for me, I've 

5 developed some decided views on these issues. 

6 Again, I've been reading the medical 

7 events reports now for a long time. I read the 

8 abnormal occurrence report then that we send forward 

9 to the Congress. It is weighted almost exclusively 

10 with medical events because we simply do not see 

11 the health significant in other aspects of our 

12 regulatory framework. We don't see the same 

13 thresholds, and so it's interesting to me as a lay 

14 person, I read the, you know, one of two paragraph 

15 description of these things that again have met the 

16 triggers and thresholds to be reported. And then 

17 as a lay person I'm reading it, and I say well, it 

18 was maybe a dose to the non-treatment site, or 

19 something else. It seems so significant to me, and 

20 then often I get all the way to the end of the 

21 description and what's stated there is the medical 

22 assessment is that there is not likely to be an 

23 adverse outcome for the patient. And so, if I 

24 struggle with that being this much closer to these 

25 types of --- of reading this type of reporting, I 

26 sometimes think to myself as we forward this on to 
 64 

1 the Congress what must they be thinking about the 

2 quality of the administration of these various 

3 techniques? And I think it's very skewed, and I think 

4 it's not accurate, and I regret that. So, when we 

5 look at the yttrium-90 microspheres, I appreciate 

6 that what we're trying to do there is begin with 

7 the end in mind, and not have a whole body of 

8 reportable events. 

9 You know, the other aspect is, of course, 

10 for a patient. How traumatizing it is for a patient 

11 and family to hear that there's something 

12 reportable. And then I'm sure they do hear the 

13 statement of but we don't assess --- frankly, when 

14 there is an adverse outcome expects, it's more 

15 likely that it's because we didn't get the treatment 

16 to the site where we wanted it, and so I think that's 

17 probably remedied in the care going forward. But 

18 in any event, great anguish, I think, is created, 

19 so there's a real --- there's a global inaccuracy. 

20 There is a patient by patient, family by family 

21 --- you know, I think a negative consequence that 

22 is unneeded, so I think that's something that I 

23 appreciate that we continue to try to look at that, 

24 and approach that in a more informed way. 

25 Also, the presentation on molybdenum-99 

26 and the tech-99m. You know, I'm reaching a point 
 65 

1 where I have been on the fringes of hearing about 

2 the impact of this fragile supply chain for so long 

3 that's developing beyond an awareness into, I'll 

4 confess, a bit of a frustration; particularly, when 

5 we look at from the time of the supply interruption. 

6 You know, the statistics are compelling in the 

7 abstract, and when you think about real patients 

8 and real families, and the fact that, you know, maybe 

9 --- we had to prioritize, and I'll use this word, 

10 ration the delivery of certain things in our country 

11 when we are so innovative, so prosperous, have the 

12 quality of medical care that we have. I just am 

13 frustrated with our national tolerance to be so 

14 vulnerable to that kind of supply chain. It is 

15 unnecessary. We should view it as intolerable. I 

16 know there are financial and other reasons, but I 

17 have sat here year by year as I've watched the plans 

18 to have U.S. capacity come. 

19 I'm actually not bothered by a foreign 

20 dependency, frankly, across our economy, the U.S. 

21 You know, we can tolerate being dependent on foreign 

22 suppliers, it's true, of rare isotope, you know, 

23 the elements and things. And I think as hopefully 

24 someday we continue as a nation to explore the 

25 promise of radiopharmaceuticals even much more 

26 broadly than we have them now, and need to produce 
 66 

1 kind of boutique quantities of things, I think 

2 having a good global supply chain is perfectly 

3 supportable. The problem is that it isn't robust 

4 globally, and so I --- you know, at some point you 

5 just want to take a deep breath and say I can't 

6 believe that we keep allowing this to be this way. 

7 And moly-99, and the tech-99m, and I've 

8 had a chance to visit manufacturer, distributors, 

9 and so I know about the elution, and I have some 

10 very rudimentary understanding of how you milk them, 

11 you know, for what you need. Again, we are 

12 innovative, in that time of shortfall, I appreciate 

13 the slide about all of the innovative ways we came 

14 up, but I still don't think it's something that we 

15 need to have going on. 

16 I mean, I appreciate that we were 

17 innovative about it, but if even one patient was 

18 affected by that, my personal view, it's one too 

19 many. So, appreciate that someday, some future 

20 Commission, some future ACMUI members are going to 

21 sit here and be able to talk about this as something 

22 that we conquered and put to rest. And I really look 

23 forward to that day. I'll be --- if I'm not in the 

24 room, I'll be somewhere tuning in cheering that 

25 quietly because we need to get on with that. 

26 And then on the input that you provided, 
 67 

1 and you I read your written comments on Part 20, 

2 which were even more detailed than what was 

3 discussed here today, there's a lot of competing 

4 things that need to be balanced there. And on the 

5 whole, I want to compliment the Committee. I felt 

6 that you balanced competing concerns and interests 

7 there. 

8 I know that ACMUI, it's difficult to our 

9 regulated practitioners of this, and so one could 

10 view your input on regulatory changes as being maybe 

11 too heavily weighted towards your day to day routine 

12 as practitioners. I don't view it that way because 

13 of this uniqueness about the delivery of medicine. 

14 We heard about recently, it was either in the 

15 Washington Post or the New York Times, a long profile 

16 critical of FDA, and I have sympathy as fellow 

17 regulators for --- I think it was about ALS and some 

18 new --- you know, where do they make --- when people 

19 are just wanting to kind of manage their illness 

20 and prolong their life. How do you balance risk, 

21 and making things available? You know, you don't 

22 want it to be snake oil about which there's just 

23 no good science at all, but on the other hand, if 

24 you're a patient or the loved one of a patient your 

25 view is I want to weight it towards riskier --- or 

26 why can't I make that decision, and why does FDA 
 68 

1 get to be the one deciding that? If my loved one 

2 could get one more month, he or she wants that, so 

3 I appreciate, you know, your sensitivity, because 

4 I view your comments as trying to balance that risk, 

5 which is different than the power reactor side. And 

6 we need to keep our sensitivity tuned very high on 

7 that. 

8 I also appreciate your sensitivity to 

9 the needs of women working in this field when it 

10 came to the embryo and fetus. I think you have a 

11 euphemistic statement in there of it's an area of 

12 controversy. It's difficult, but there are a lot 

13 of competing things to try to balance there. And 

14 in instances where we could be more prescriptive 

15 or intrusive, I took your comment document to state 

16 that what you're trying to do is say what is the 

17 benefit to be gained from this? And you're balancing 

18 that burden and these other downsides with that. 

19 So, I appreciate that. 

20 So, maybe stepping back really 

21 generally, one thing that I would be interested in 

22 understanding from the Committee, we had an 

23 editorial in some trade press a few weeks ago about 

24 NRC speaking of the media being critical. In this 

25 instance in Energy Daily, there was an opinion piece 

26 that NRC's very, very complex regulatory framework 
 69 

1 is likely impeding the rollout of new nuclear 

2 power-related technologies. 

3 Your Committee provides input to us on 

4 I think it's every year or every other year about 

5 the effectiveness of the Committee structure, the 

6 composition, and things like that. One of the things 

7 that you provide feedback on is whether or not you 

8 feel the Commission, and I don't know if in answering 

9 that question you mean the individual members of 

10 the Commission, or the Agency as a whole, has a good 

11 understanding of what --- of the practice of nuclear 

12 medicine and what it means to deliver that every 

13 day, again, through the prism of, you know, patient 

14 care and patient outcomes, which is really what's 

15 driving you. 

16 If there was something that we could 

17 understand better in the --- you know, we can't 

18 become you, and we have a lot of other things we're 

19 working on, but what would be --- if we had an extra 

20 hour each week to get smarter on these issues, if 

21 any of you just want to chime in. I'm a little over 

22 my time, but I'd like to know since I'm doing wrap-up 

23 on the Q&A. What do you think is the keenest gap 

24 in terms of what --- the ways you've engaged with 

25 NRC or this Commission over the years? 

26 DR. THOMADSEN: I would look at two 
 70 

1 issues, and I'm not sure that you can deal with one 

2 of them, and that is the issue that came up dealing 

3 with the ability to adapt regulations as quickly 

4 as needed to deal with the issues that are raised 

5 in the community. The changes in regulations have 

6 to be transparent, and certainly the NRC works very 

7 hard at doing that. You have to get the input from 

8 all of the stakeholders, and the NRC works very hard 

9 at doing that. I think you do a commendable job at 

10 trying to bring in all of the various viewpoints. 

11 The problem is it still takes an awfully 

12 long time. The rules for changing regulations do 

13 not provide for rapid changes. They probably should 

14 not allow changes too rapidly, but there should be 

15 some way to address the issues more quickly than 

16 what they are now. 

17 The other one, I think in general for 

18 the --- from our point of view, our interactions 

19 with the NRC Staff have actually been stellar. The 

20 NRC Staff that we work with are incredibly sensitive 

21 to the issues that we're dealing with, and are trying 

22 to deal with them as expeditiously and effectively 

23 as possible. That is not always true for all of the 

24 people in the field, as we've mentioned. And I think 

25 the issue that we were discussing earlier of trying 

26 to establish a way to help facilities improve what 
 71 

1 they do, particularly when they have the opportunity 

2 to see their weaknesses through an event, could 

3 certainly be improved and make life less 

4 adversarial. That does not usually help the facility 

5 in trying to grapple with the issues. They need 

6 people who can help them, and they aren't afraid 

7 to deal with. 

8 Those would be my two takes on what might 

9 be issues that the NRC should consider thinking 

10 about. 

11 COMMISSIONER SVINICKI: Thank you. 

12 Would anyone else like to offer anything? 

13 MR. COSTELLO: On the rulemaking, have 

14 to bring that up again and the germanium. I just 

15 call to your attention why I think that should be 

16 a simple change. There's a table in Part 20 which 

17 gives the quantities of material requiring 

18 labeling. There's a table in Part 30 which provides 

19 the quantities of material requiring labeling. 

20 They're titled exactly the same. 

21 The requirement for decommissioning in 

22 Part 30 refers to the table at Part 30. 

23 Unfortunately, the table in Part 30 was really not 

24 changed after the 2005 Atomic Energy Act revisions, 

25 so it doesn't have a quantity for germanium-68. So, 

26 you have to use the default quantity. In Part 20, 
 72 

1 there is a quantity for germanium-68, and if you 

2 could use that quantity there would be no problem 

3 with decommissioning. So, you have two regulations, 

4 Part 20 and Part 30, with identical tables with 

5 different values. One would think that would be a 

6 regulatory change that would be easy to make. It 

7 almost could be well, we made a mistake. They should 

8 be the same. But I don't believe that that, like 

9 any regulatory change, can be made inside a year. 

10 COMMISSIONER SVINICKI: Well, I'm over 

11 my time, but I'll just close with this. I didn't 

12 speak to rulemaking, specifically. Just so you know, 

13 this is not unique to the nuclear medicine parts 

14 of our regulation. We have over the course of decades 

15 now been attempting to embed in our regulations a 

16 risk-informed performance-based standard, and what 

17 that allows you to do is to have in guidance 

18 appropriate, you know, procedures, methodologies, 

19 compliance pathways so that the regulations 

20 themselves can be robust. But as I sometimes tell 

21 the NRC Staff, in my view, the easiest regulation 

22 or regulation change to draft is the most 

23 prescriptive. To make things robust enough to just 

24 be a performance-based or a risk-informed outcome, 

25 that's I think the nuanced work. And it's harder 

26 to do. We do try to do it. It's a principle espoused, 
 73 

1 again, of long standing for NRC, but that allows 

2 us as modalities, you know, changes, as techniques 

3 evolve, you can simply have it accommodated and not 

4 need to make a rule change. We do try on the reactor 

5 side, we've been trying to have a technology-neutral 

6 framework for a long time, but it's just --- it's 

7 hard work. But that's why we embrace that principle, 

8 but thank you all, again. 

9 CHAIRMAN BURNS: Thank you, 

10 Commissioner. Before we close, anything else? 

11 I want to, again, thank members of the 

12 Committee for appearing today and providing very 

13 interesting briefing on the various topics related 

14 to medical uses of isotopes. I think it's important 

15 to hear these views as we look at our regulatory 

16 program to hear areas where we may need to focus, 

17 and to not have unintended effects in terms of the 

18 safe use of radiomedicine. And I, again, also 

19 appreciate the participation of all of you, and Ms. 

20 Weil in terms of as a Patient Advocate, because it's 

21 also important to hear those views and that side 

22 of the story, as well. 

23 So, again, thank you, and with that we're 

24 adjourned. 

25 (Whereupon, the above-entitled matter 

26 went off the record at 11:14 a.m.)