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1 Report of 

2 Proposed Amendments to ACMUI Bylaws 

3 Advisory Committee on Medical Uses of Isotopes (ACMUI) 

4 

5 

6 Subcommittee Members: 

7 Steven Mattmuller, Christopher Palestro, John Suh, 

8 Orhan Suleiman, Laura Weil, and Pat Zanzonico (Chair) 

9 

10 Dates: Original (V 1), March 31, 2014 

 1st 11 Revision (V 2), April 1, 2014 

 2nd 12 Revision (V 3), April 2, 2014 

 3rd 13 Revision (V 4), April 7, 2014 

 4th 14 Revision (V 5), April 9, 2014 

15 Draft Final (V 6), April 11, 2014 

16 Final, May 08, 2014

17 

18 

19 Introduction

20 The Sub-Committee on Proposed Amendments to Bylaws of the Advisory Committee on 

21 Medical Uses of Isotopes (ACMUI) to the Nuclear Regulatory Commission (NRC) was charged 

22 with the following tasks: 

23 1. Discuss, address, review and identify any additional amendments to the amended ACMUI 

24 Bylaws originally proposed in September 2013; 

25 2. Discuss, address, and make a recommendation for the ACMUI reporting structure (MSSA 

26 director versus the Commission); 

27 3. Discuss, address, and make a recommendation for the consideration of budgeting for an 

28 additional face-to-face meeting at Headquarters; and 

29 4. Consider the feasibility of conducting meetings using the Go-To-Meeting or Go-To30 Webinar function. 

31 

32 These tasks are addressed in numerical order below. 

33 

34 

35 1. Discuss, address, review and identify any additional amendments to the ACMUI Bylaws

36 The Bylaws describe the procedures to be used by the ACMUI in carrying out its duties and 

37 the responsibilities of the Committee members. These duties are as follows: “...to provide 

38 objective and independent advice to the NRC staff in the Division of Materials Safety and 

39 State Agreements, Office of Federal and State Materials and Environmental Management 

40 Programs (FSME), with respect to the development of standards and criteria for regulating 

41 and licensing medical uses of byproduct material.” The proposed Bylaws largely duplicate 

42 the previous version of the ACMUI Bylaws, dated October 24, 2006. 

43 

44 

45 General Comments 

46 a. NRC Legal Counsel review 
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47 Some issues that are considered in the Bylaws and, more generally, that may come before 

48 the ACMUI have legal implications and may, as recommended by NRC staff, require input 

49 from Legal Counsel for their ultimate resolution. It would helpful to include an explicit 

50 statement to this effect somewhere in the Bylaws, perhaps in the Preamble. 

51 

52 b. § 1.1.5: Webcasting of public portions of ACMUI meetings 

53 Section § 1.1.5 states that. “Portions of ACMUI meetings that are open to the public will be 

54 webcast...” Should this be generalized to include all electronic-dissemination modalities by, 

55 for example, changing the term, “webcast,” to, “broadcast or otherwise electronically 

56 disseminated (eg webcast)”? More importantly, the use of the word, “will,” implies that an 

57 ACMUI meeting could not proceed even if webcasting or other electronic dissemination 

58 were not possible. A provision should be considered to allow an ACMUI meeting to proceed 

59 even if webcasting or other electronic dissemination were not technically do-able. Perhaps 

60 § 1.1.5 should be revised as follows, “Portions of ACMUI meetings that are open to the 

61 public will be webcast whenever possible, with closed captioning in accordance with the 

62 Americans with Disabilities Act. 

63 

64 c. § 3.1: Term limits of ACMUI members 

65 The immediate past ACMUI Chair, Dr. Leon Malmud, served three terms, so a mechanism 

66 for granting an exemption from the two-term limit is in place. The Sub-Committee therefore 

67 recommends including a statement in Section § 3.1 noting that exemptions to the two-term 

68 limit may be granted. 

69 

70 

71 Specific Comments 

72 Pg 2, § 1.1.1 There is some concern that, as written, this provision 

73 potentially allows arbitrary cancellation of the annual meeting 

74 between the Commission and the ACMUI. Language 

75 specifying the circumstances under which these meetings can 

76 be cancelled should be included, therefore.

77 

78 Pg 2, § 1.1.1 Line 5 The phrase, “...of the ACMUI...,” should be inserted between 

79 the words, “Chair” and “declines.” 

80 

81 Pg 2, § 1.1.3 Are all ACMUI meetings and all portions of meetings 

82 transcribed/recorded or only those portions of meetings open 

83 to the public? This point should be addressed explicitly in the 

84 Bylaws. 

85 

86 Pg 2, § 1.1.6 Line 1 We suggest changing the phrase, “All meeting handouts will 

87 be electronically transmitted...,” to, “All available meeting 

88 handouts should be electronically transmitted...” 

89 

90 This suggested change would potentially avoid cancellation of 

91 a scheduled ACMUI meeting in the event that not all handouts 

92 were available for distribution two weeks prior to the meeting. 

93 

94 Pg 2, § 1.1.7 Line 1 For the same reason for the suggested revisions to § 1.1.6, we 

95 suggest the word, “will,” be changed to, “should.” 

96 
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97 Pp 2-3, § 1.2 Lines 6 and 7 For the same reason for the suggested revisions to § 1.1.6, 

98 and 1.1.7, we suggest the word, “will,” be changed to, 

99 “should.” 

100 

101 Pg 3, § 1.3.1 Line 1 The phrase, “All ACMUI meetings...,” should be changed to, 

102 ““All ACMUI meetings and ACMUI Sub-Committee 

103 meetings...” 

104 

105 Pg 5, § 4.2 Lines 3-4 This section states that. “The hours shall be transmitted via 

106 email to the time resource inbox at 

107 ACMUI_MedConsultTime.Resource@nrc.gov.” Identification 

108 of a specific hyperlink for submission of work hours seems 

109 unnecessarily restrictive and potentially problematic (eg in the 

110 event the hyperlink is changed). It is suggested, therefore, 

111 that this statement be revised as follows, “The hours shall be 

112 transmitted to the NRC in the manner specified by staff.” 

113 

114 

115 2. Discuss, address, and make a recommendation for the ACMUI reporting structure 

(MSSA director versus the Commission)1 116 

117 At its teleconference of January 12, 2011 and its semi-annual meeting of September 20, 

118 2012, the ACMUI recommended an annual review of its reporting structure. The current 

119 ACMUI reporting structure is summarized in the figure below (provided by Ms. Sophie 

120 Holiday, ACMUI Coordinator, Office of Federal and State Materials and Environmental 

121 Management Programs (FSME)). The key issue remains whether there is a significant 

122 benefit to be derived by the ACMUI reporting directly to the Commission rather than through 

123 the Office of Materials Safety and State Agreements (MSSA), the FSME, and the Executive 

124 Director for Operations (EDO). The consensus opinion of the ACMUI was that there was 

125 perhaps a “theoretical” advantage for reporting of the ACMUI to the Commission (eg 

126 unfiltered transmission of opinions from the ACMUI to the Commission). However, the 

127 working relationship between the NRC and ACMUI remains excellent, the reporting structure 

128 through NRC staff (see figure below) continues to function effectively, and the associated 

129 logistical “overhead” associated with direct reporting to the Commission (eg the need for 

130 more frequent meetings) did not and does not now justify any change in the ACMUI’s 

131 reporting structure. This recommendation is predicated on the annual Commission Briefing 

132 by the ACMUI and the annual review of its reporting structure remaining in place. 

133 

 

1 Relevant information is provided in Federal and State Materials and Environmental Management 

Programs (FSME) Policy and Procedures (P&P) 2-5, Revision 0 (January 12, 2011), entitled, “FSME 

Procedure for Interacting with the Advisory Committee on the Medical Uses of Isotopes During 

Development of Major Medical Issues.” This P&P defines and documents FSME staff guidance and 

procedures for interfacing with the ACMUI during the development of major medical policy issues 

including medical rulemakings that will be reviewed by the Commission. 
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134 

135 

136 

137 3. Discuss, address, and make a recommendation for the consideration of budgeting for 

138 an additional face-to-face meeting at Headquarters

139 At the present time, the ACMUI holds two face-to-face meetings annually at NRC 

140 Headquarters, one in the spring and one in the fall. This schedule provides ample 

141 opportunity for timely and in-depth discussion of issues within the purview of the ACMUI. 

142 Additional face-to-face meetings (ie more than two meetings annually) are therefore 

143 probably unnecessary. On the other hand, the two-day Agendas of the ACMUI face-to-face 

144 meetings are typically full, so eliminating one such meeting per year would be 

145 counterproductive and impractical (especially considering recurring administrative tasks 

146 such as annual ethics and security training required of the Committee membership). 

147 Further, holding regularly scheduled meetings at 6-month intervals serves to maintain the 

148 timeliness of ACMUI deliberations; less frequent meetings (ie once a year) would likely 

149 result in new and pressing issues remaining unaddressed for a considerable period of time. 

150 (An example of just such an issue was the CardioGen-82 rubidium-82 generator 

151 breakthrough issue in 2011.) Another option, of course, is to replace one or both face-to152 face meetings at Headquarters with web-based conferences (through Webex or Go-to153 Meeting, for example). This, too, would undermine the effectiveness of the Committee. 

154 The ACMUI membership consists of individuals with many time-critical day-to-day 

155 responsibilities at their respective institutions. It is difficult, if not impossible, to completely 

156 divest one’s self of those responsibilities for several days at a time when physically present 

157 at one’s home institution. Inevitably, participants in such a web-based conference would be 

158 diverted from the meeting at some point to attend to some pressing local issue. 

159 Furthermore, in contrast to face-to-face meetings, it is difficult in a web-based scenario to 

160 promote the spirit of collegiality and camaraderie among the participants that, in turn, 

161 promotes frank, constructive discussion. This is especially important for newer ACMUI 

162 members. It is logistically difficult as well to promote such discussion, since the Chair may 
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163 not be able to recognize Committee members wishing to speak in a timely manner, for 

164 example. The Sub-Committee therefore recommends maintaining the current ACMUI 

165 schedule of two face-to-face meetings annually at NRC Headquarters. 

166 

167 

168 4. Consider the feasibility of conducting meetings using the Go-To-Meeting or Go-To169 Webinar function

170 Web-based conferencing (through Webex or Go-to-Meeting, for example) is now a 

171 mature, reliable, universally available, inexpensive, and easy-to-use technology. It is 

172 adaptable not only to desk and laptop PCs but also all mobile devices. Web-based 

173 conferencing provides the obvious advantages of direct, real-time audio and video 

174 communication among multiple individuals throughout the world, dramatic savings in time 

175 and money with respect to travel, convenience, and flexible scheduling. It not only allows 

176 display of any one of the attendee’s computer screen to all other attendees of a conference 

177 but also remote control by any one of the attendees of another attendee’s computer and its 

178 display. It is therefore far superior to conventional teleconferencing, which is restricted, of 

179 course, to audio communication, and is especially useful for real-time editing of documents 

180 through its common-display functionality. Web-based conferencing is therefore a potentially 

181 important complement to face-to-face meetings. As discussed above, however, it is not a 

182 viable replacement altogether for face-to face meetings. Inevitably, prolonged, dedicated (ie 

183 interrupted) discussion is required to address the complex issues which often confront the 

184 ACMUI, and such discussion is not realistically achievable via web-based conferencing. 

185 The Sub-Committee therefore endorses the use of web-based conferences as needed as a 

186 supplement to, but not as a replacement for, face-to-face meetings.