Meeting Summary: Medical Rulemaking Workshop for Discussion of Topics Related to 

Medical Part 35 Regulations 

The second of two facilitated public medical rulemaking workshops was held on August 11-12, 

2011, in Houston, TX. The purpose of the workshop was to solicit key stakeholder input on 

topics associated with the medical event (ME) definition, including sections involving reporting 

and notifications of MEs for permanent implant brachytherapy, and other medical issues that are 

currently being considered for rulemaking. These workshops were initiated as a result of the 

Commission’s direction to staff to work closely with the Nuclear Regulatory Commission’s 

(NRC’s) Advisory Committee on the Medical Uses of Isotopes (ACMUI) and the medical 

community to develop event definitions that would protect the interests of patients. The 

Commission also directed that these definitions should also allow physicians the flexibility to 

take actions that they deem medically necessary, while preserving the NRC’s ability to detect 

misapplications of radioactive material and failures in process, procedure and training. 

The workshop began with opening remarks from Michael Weber, NRC’s Deputy Executive 

Director for Materials, Waste, Research, State, Tribal and Compliance Programs. He welcomed 

the distinguished panelists and explained the purpose of the meeting. He also encouraged 

active participation and highlighted the NRC staff and Commission’s interest in better 

understanding the views and perspectives of the medical and broader stakeholder community 

on the issues that are under consideration for medical rulemaking. 

The workshop featured two separate panels of participants representing the diversity of 

stakeholders for these issues and was dedicated to panel presentations and discussions. The 

panelists included representation from the NRC’s ACMUI, the Organization of Agreement States 

(OAS), professional societies, and a patients’ rights advocate. Following Mr. Weber’s opening 

remarks, each panelist gave a presentation on their perspectives on the following topics 

delineated in the May 20, 2011, Federal Register Notice (76 FR 29171): ME definition 

association with permanent implant brachytherapy, amending preceptor attestation requirements, 

extending grandfathering to certified individuals, naming associate/assistant radiation safety 

officers (RSOs) on an NRC medical-use license, additional molybdenum breakthrough testing and 

reporting requirements, and additional 10 CFR 35 items under consideration for rulemaking. The 

presentations were followed by discussions of the topics amongst the panelists, after which, 

audience members including those present via webinar/teleconference, were given the 

opportunity to make comments, offer input on each topic item, and ask questions of the 

panelists. 

The first day of the workshop was devoted to panel presentations and a panel discussion on the 

medical event definition as it relates to permanent implant brachytherapy. A wide variety of 

perspectives and views were expressed. The following key messages or themes were 

conveyed during the discussions: 

 Among the States, there are fairly consistent regulations, but there can be wide variance 

among a few States in the interpretation and implementation of those regulations. This 

may warrant the need for training of licensees as well as regulators. Also, it was noted 

that none of the States that had recently responded to an OAS questionnaire advocated 

for a ME definition based upon total source strength (or activity). 

 All of the panelists, except for the OAS representative, recommended that the definition 

of medical events as it relates to permanent implant brachytherapy needs to be revised, 
and it should be based upon total source strength (activity) and not absorbed dose. If 

the definition is based upon total source strength, then a tolerance of + 20% is 

reasonable. Contrary to the comments received at the New York workshop, participants 

were not in support of an absorbed dose criterion being appropriate for defining a ME for 

unintended organs and tissue. In fact some of the participants stated that the dose to 

unintended organs and tissue should not be under the purview of the regulators, and 

that the related section in 10 CFR Part 35.3045 should be eliminated. 

 Several of the panelists stated that, for prostate implants in particular, absorbed dose is 

very difficult to quantify and is a very subjective value. 

 Many of the panelists agreed that the “D-90” value poorly predicts clinical outcomes, 

lacks precision, and should not be used for regulatory purposes. 

 The term “Medical Event” should be reserved for those instances where there is real 

harm to the patient or a potential for same (clinically significant). If the regulators need 

to capture less serious events, then there should be more than one category so that 

serious events can be distinguished from “near misses.” 

 Licensee staff should be trained in the policies and procedures for identifying MEs. 

 The patients’ rights advocate panelist stated that the patient/doctor relationship is changing, 

and that many patients today view themselves as “medical service consumers.” This 

change in attitudes suggests that more and more individuals wish to share in the decisionmaking process when their personal medical care is being discussed and considered. 

Therefore, more information, not less, should be shared. 

 The Authorized User (AU) should be required to attest in writing that the distribution of 

seeds within the target volume was implanted as intended. Participants were in support 

of requiring post implant imaging. 

The second day of the workshop was devoted to panel presentations and a panel discussion on 

preceptor attestation requirements and extending grandfathering to certified individuals, as well as 

NRC staff presentations on other medical rulemaking topics including – naming 

associate/assistant RSOs, and molybdenum breakthrough requirements. Additionally, the 10 CFR 

35 preliminary draft proposed rule language that was made publicly available at the beginning of 

the workshop was discussed. The following key messages or themes were conveyed during the 

discussions: 

 NRC should remove the requirement for attestation for board certified AUs, Authorized 

Medical Physicists, RSOs, and Authorized Nuclear Pharmacists (ANPs). Board 

Certification coupled with the “recentness of training” requirement should be sufficient for 

the regulator’s needs. Also, the elimination of attestation for Board certified individuals 

does not eliminate the issues surrounding the need to extend grandfathering to certain 

certified individuals. 

 There should be no requirement for attesting to someone’s competency, but rather 

preceptors should be attesting to someone’s training and experience necessary to carry 

out one’s responsibilities independently. The general consensus was that maintenance 
of board certification is important for all medical professionals as it covers activity of the 

licensee, training, and recentness in the field, and it demonstrates competency. 

 NRC should allow for the naming of associate/assistant RSOs on an NRC medical-use 

license. There should be no arbitrary limit placed on the number that can be so named. 

Also, what the additional individuals are called matters because certain terms have 

particular meaning, so some care needs to be exercised here. 

 There should be a new requirement for testing each Mo-99/Tc-99m generator elution 

(not just the first elution), but there should not be a requirement for NRC licensees to be 

required to report failures to NRC. Also, the rules in this area should be generic, and not 

reference particular radiopharmaceuticals. 

During the final session on the second day, an NRC staff person from the Division of 

Intergovernmental Liaison and Rulemaking (DILR), led the participants through a review of the 

10 CFR Part 35 preliminary draft proposed rule language. The following were key points of 

discussion for the language in specific sections: 

• 35.13(h) regarding access to the sealed source and device (SS&D) registry; 

• 35.14(b)(6) regarding the need to identify the activity of each source or maximum activity 

that is not to be exceeded; 

• 35.65 regarding the removal of transmission sources and including it in 35.500; 

• 35.65 regarding the need for bundling and aggregation of single sources defined with 

respect to risk; 

• In 35.290, consider the removal of training requirements that AUs must be required to 

elute generators; 

• In 35.390, consider a separate category for parenteral administrations, but not specify a 

separate provision for alpha emitters; 

The NRC staff considers the workshop to have been very successful in soliciting key stakeholder input 

on a variety of Part 35 topics. NRC staff received substantive and useful comments and suggestions 

from key stakeholders representing the broad range of medical licensees, the ACMUI, the States, and 

other stakeholders. 

For further information contact: 

Michael Fuller, telephone (301) 415-0520, e-mail Michael.Fuller@nrc.gov, or 

Gretchen Rivera-Capella, telephone (301) 415-5944, e-mail Gretchen.Rivera-Capella@nrc.gov. 

Documents relevant to the workshop, including transcripts, are posted on the following web-site: 

http://www.blsmeetings.net/NRCMedicalRulemakingWorkshop/.