1 

TELECONFERENCE MEETING OF THE 

ADVISORY COMMITTEE ON THE 

MEDICAL USES OF ISOTOPES 

February 7, 2012 

MEETING SUMMARY

PURPOSE

To discuss the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Permanent Implant 

Brachytherapy Subcommittee Report as it relates to the implementation of the medical regulations 

in Title 10, Code of Federal Regulations (CFR) Part 35, “Medical Use of Byproduct Material.” 

OUTCOME 

The ACMUI Permanent Implant Brachytherapy Subcommittee (PIBS) provided a draft report for the 

ACMUI’s consideration. During the meeting, the PIBS made recommendations to revise the report, 

and the revisions were approved by the full committee, as described below. The PIBS draft report 

was endorsed by the full ACMUI with one dissenting opinion. The U.S. Nuclear Regulatory 

Commission (NRC) staff gained a better understanding of the views and opinions of the ACMUI, as 

well as other stakeholders’ views and opinions. The staff will consider these views in its continuing 

effort to make 10 CFR Part 35 more useful, practical, and not overly burdensome on licensees, 

while maintaining public health and safety. 

Full transcripts of the ACMUI meeting can be found on NRC’s public website: 

http://www.nrc.gov/reading-rm/doc-collections/acmui/tr/

Handouts from the ACMUI meeting can be found on NRC’s public website: 

http://www.nrc.gov/reading-rm/doc-collections/acmui/meeting-slides/

Permanent Implant Brachytherapy Rulemaking Final Report (2012) can be found on NRC’s public 

website under “Related Information”: http://www.nrc.gov/about-nrc/regulatory/advisory/acmui.html

ATTENDEES 

ACMUI

Darice G. Bailey Member 

Milton S. Guiberteau, M.D. Member 

Susan M. Langhorst, Ph.D. Member 

Leon S. Malmud, M.D. Chairman 

Steve R. Mattmuller Member 

Christopher J. Palestro, M.D. Member 

John H. Suh, M.D. Member 

Orhan H. Suleiman, Ph.D. Member 

Bruce R. Thomadsen Ph.D. Vice Chairman 

Laura Weil Member 

James S. Welsh, M.D. Member 

Pat Zanzonico, Ph.D Member 
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NRC

Brian McDermott Director, Division of Materials Safety and State 

 Agreements 

Pamela Henderson Acting Deputy Director, Division of Materials Safety and State 

 Agreements 

Michael Fuller Designated Federal Officer 

Ashley Cockerham Alternate Designated Federal Officer and ACMUI Coordinator 

Maria Arribas-Colon NRC staff 

Susan Chidakel NRC staff 

Said Daibes, Ph.D. NRC staff 

Sandra Gabriel, Ph.D. NRC staff Region I 

Latischa Hanson NRC staff Region IV 

Donna-Beth Howe, Ph.D. NRC staff 

Patricia Pelke NRC staff Region III 

Gretchen Rivera-Capella NRC staff 

Lizette Roldan-Otero, Ph.D. NRC staff Region IV 

Ronald Zelac, Ph.D. NRC staff 

MEMBERS OF THE PUBLIC:

Dr. Keith Brown – University of Pennsylvania 

Karen Colucci – Albert Einstein Healthcare Network 

Robert Dansereau – New York State Department of Health 

William Davidson – University of Pennsylvania 

Dr. Ronald Ennis – American Society for Radiation Oncology 

Lynne Fairobent – American Association of Physicist in Medicine 

Peter Goyer – Albert Einstein Healthcare Network 

Dr. Thomas Huston – Veterans Health Administration 

Dennis Kehoe – Jeppensen Radiation Oncology Center 

Ralph Lieto – St. Joseph Mercy Hospital 

Janette Merrill - Society of Nuclear Medicine 

Dr. Subir Nag – Kaiser Permanente 

Michael Peters – American College of Radiology 

Dr. Bradley Prestidge – American Brachytherapy Society 

Joseph Rodgers – Theragenics Corporation 

Gloria Romanelli – American College of Radiology 

Karen Sheehan – Fox Chase Cancer Center 

Michael Sheetz – University of Pittsburgh 

Eric Soltycki – Albert Einstein Healthcare Network 

Cindy Tomlinson – American Society for Radiation Oncology 

AGENDA TOPIC

Permanent Implant Brachytherapy Subcommittee Report 

 
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RECOMMENDATIONS AND ACTIONS 

The subcommittee made the following changes to the draft report show in italics below: 

1. Page 1, “Recommendations” A.2.a. For neighboring structures (such as the bladder or 

rectum in prostate implants as an example), the dose to at least 5 contiguous cm3

(contiguously) exceeds 150% of the dose prescribed to the CTV or PTV. 

2. Page 1, “Recommendations” A.2.b. For intra-target structures (such as the urethra in 

prostate implants as an example), the dose to at least 5 contiguous cm3 (contiguously)

exceeds 150% of that structure’s expected dose based on the approved pre-implant, dose 

distribution. 

3. Page 2, “Recommendations” B. The Authorized User should provide a statement in this 

Written Directive Completion attesting that the permanently implanted sources have been 

placed in accordance with the final planned distribution. 

The first two changes were unanimously approved by the ACMUI. The third change was approved 

by the ACMUI; however, Dr. Thomadsen abstained because he did not support the concept of 

attestations in the Written Directive. 

The Draft ACMUI Permanent Implant Brachytherapy Subcommitee Report modified January 2012, 

(ML12019A196) was approved by the ACMUI with the three changes noted above and one 

opposing vote. Dr. Thomadsen voted against the current report and stated his continued support 

for the October 18, 2011 version (ML11292A139). Dr. Thomadsen’s comments are summarized in 

the “Minority Report” section of the current report dated February 7, 2012 (ML12038A279).