ML18099A265
| ML18099A265 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes, Office of Nuclear Material Safety and Safeguards |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18099A265 (4) | |
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2011 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS ACMUI endorsed the draft response to NRC comments, as reflected in the meeting handout (ML110600249). ACMUI agreed if NRC believes the release criteria should be changed from a per release criteria to an annual criteria, this Closed 1 change would require new rulemaking, as stated in Regulatory Issue Summary 1/5/11 Pending 3/7/18 (RIS) 2008-07. ACMUI recommended rulemaking to clarify that the release under 10 CFR 35.75 is per release and not per year ACMUI recommended NRC staff maintain the current reporting structure for the ACMUI Closed 2 Committee; however, the motion was tabled for further discussion at the January 1/5/11 Action 1/12/11 12, 2011 ACMUI Teleconference ACMUI endorsed the draft comments on proposed 10 CFR Part 37, as reflected Closed 3 1/5/11 Accepted in the meeting handout (ML110600261) 1/5/11 Closed 4 ACMUI endorsed the Draft Final Safety Culture Policy Statement 1/5/11 Accepted 1/26/11 ACMUI recommended NRC staff maintain the current reporting structure for the Closed 5 ACMUI with enhancements in communication as described in FSME Policy and 1/12/11 Accepted 4/1/11 Procedure 2-5 and increased technical and administrative support staff.
ACMUI created an action item to reevaluate its satisfaction with the reporting ACMUI Open 6 1/12/11 structure annually. Action indefinitely Dr. Malmud will serve as a reviewer to screen I-131 cases for the ACMUI No NRC 7 4/11/11 Closed Medical Event Subcommittee Action ACMUI recommended to reserve some time at the Fall ACMUI Meeting for ACMUI Did not 8 4/11/11 Public Stakeholders to discuss items for the Part 35 Public Workshops Action pass ACMUI recommended a 3 month (minimum) notice for future Public Stakeholder 9 4/11/11 Accepted Closed Workshop Meetings.
ACMUI recommends NRC Staff hold the second Public Stakeholder Workshop in August in order to accommodate all public stakeholders, with the caveat that Closed 10 4/11/11 Accepted the ACMUI Permanent Implant Brachytherapy Subcommittee Report be finalized 2/7/12 by the Fall ACMUI Meeting.
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2011 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS (1) ACMUI feels ASTRO's approach to Permanent Implant Brachytherapy (handout) is correct approach for patient welfare (2) ACMUI recommends that the NRC require Post-Implant dosimetry following brachytherapy treatment (3) Partially Closed 11 4/11/11 ACMUI believes that prostate brachytherapy is a unique subset of brachytherapy Accepted 3/7/18 and should therefore require a separate set of rules from non-prostate brachytherapy.
ACMUI has planned to hold the Fall 2011 ACMUI Meeting on September 22 -
Closed 12 23, 2011. The back-up date is October 27 - 28, 2011. The alternate back-up 4/11/11 Accepted 9/22/11 date is October 31 -November 1, 2011 ACMUI recommends to eliminate the written attestation for board certification Closed 13 4/12/11 Accepted pathway, regardless of date of certification 3/7/18 ACMUI recommends the attestation to be revised to say has received the Closed 14 requisite training and experience in order to fulfill the radiation safety duties 4/12/11 Accepted 3/7/18 required by the licensee ACMUI supports the statement that residency program directors can sign attestation letters, representing consensus of residency program faculties, if at Closed 15 least one member of the faculty is an AU in the same category as that 4/12/11 Accepted 3/7/18 designated by the applicant seeking authorized status, and that AU did not disagree with the approval.
ACMUI continues to assert that the current regulations are based on a per release limit. ACMUI does not recommend any change to the regulation and Closed 16 does not recommend the NRC consider this topic during the current rulemaking 4/12/11 Pending 3/7/18 process, as there is no clinical advantage or advantage to members of the public for using an annual limit.
17 Dr. Welsh asked NRC Staff if ACRS Members are considered SGE's. If so, NRC given the number of their committee and subcommittee meetings, how many 9/22/11 Closed action days and hours do they work a year?
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2011 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 18 Dr. Welsh asked that NRC Staff provide the ACMUI with the NRC's response to NRC 9/22/11 Closed Congressman Markey regarding patient release. action 19 Steve Mattmuller asked that NRC Staff add ACMUI to the organizational chart 9/22/11 Accepted Closed on the FSME website.
20 Dr. Langhorst requested that NRC staff 1) place historical documents on the ACMUI website that would give everyone a better understanding of the ACMUI 9/22/11 Accepted Closed organization and how it got to where it is today and 2) NRC add past ACMUI membership information on the ACMUI Website.
21 Dr. Malmud created a subcommittee to address electronic signatures for documents licenees are required to retain in accordance with 10 CFR Part 35. ACMUI Closed 9/22/11 Subcommittee members include: Dr. Bruce Thomadsen (chair), Dr. John Suh, Action 4/16/12 Dr. Christopher Palestro, and Dr. James Welsh 22 ACMUI Closed ACMUI recommends to table the discussion on changes to the AO criteria 9/23/11 Action 12/15/11 23 Dr. Leon Malmud added Dr. John Suh to the Permanent Implant Brachytherapy ACMUI Closed Subcommittee. Existing subcommittee members include: Dr. James Welsh 9/23/11 Action 4/16/12 (chair), Dr. Susan Langhorst, Dr. Orhan Suleiman, and Dr. Bruce Thomadsen The Permanent Implant Brachytherapy Subcommittee will revise the ACMUI Closed 24 subcommittee report and distribute to the full committee for review by October 7, 09/23/2011 Action 10/18/11 2011.
The ACMUI planned a teleconference for October 18, 2011, 12:00pm - 2:00pm ACMUI Closed 25 EDT to discuss and finalize the Permanent Implant Brachytherapy Subcommitee 09/23/2011 Action 10/18/11 Report.
NRC staff will provide an advanced copy of the Permanent Implant Closed 26 Brachytherapy Subcommitte report to the Agreement States prior to the ACMUI 09/23/2011 Accepted 10/18/11 teleconference call and will invite the States to participate in the call.
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2011 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 27 ACMUI has planned to hold the Spring 2012 ACMUI Meeting on April 16-17, ACMUI Closed 9/23/11 2012. Back-up dates are April 26-27, 2012. Action 4/16/12 28 ACMUI recommends the language in item A1B of the PIBS Report to read as, "Within a timeframe to be determined by the Authorized User consistent with ACMUI Closed 10/18/11 prevailing practice, but not to exceed 60 days unless accompanied by written Action 10/18/11 justification."
29 ACMUI recomments to insert the following phrase into item 3B of the PIBS ACMUI Closed Report "using the wrong radionuclides or wrong activity or source strength (+/- 10/18/11 Action 10/18/11 20%)" and moving the rest of the items down (from 3B to 3C and so forth) 30 Dr. Zelac suggested to change the verbage in the PIB Report, Section A number 1(a)(i) from, "greater than 20 percent of the sources fall out of the intended ACMUI Closed 10/18/11 locations." to "20 percent or more of the sources as called for in the Written Action 10/18/11 Directive".
31 Dr. Zelac suggested to change "Terminology," and specify the definition of D-90 ACMUI Closed 10/18/11 to read as "the minimum dose to 90 percent of the CTV" in the PIBS Report. Action 10/18/11 32 ACMUI reaffirms the 2008 AO Criteria as stated in the handout with the amendment that (s) be added to the end of physician, to read "consultant 12/15/11 Accepted Closed physician(s)"
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