POLICY ISSUE 

NOTATION VOTE 

April 5, 2012 SECY-12-0053

FOR: The Commissioners 

FROM: R. W. Borchardt 

 Executive Director for Operations 

SUBJECT: RECOMMENDATIONS ON REGULATORY CHANGES FOR 

 PERMANENT IMPLANT BRACHYTHERAPY PROGRAMS 

PURPOSE: 

This paper provides the staff’s recommendations for modifying the requirements in Title 10 of 

the Code of Federal Regulations (10 CFR) Part 35, “Medical Use of Byproduct Material,” for 

permanent implant brachytherapy programs. This paper does not address any new 

commitments or resource implications. 

SUMMARY: 

The Nuclear Regulatory Commission (NRC) staff is recommending amendments to the 

regulatory requirements for permanent implant brachytherapy programs that appear in 10 CFR 

35.40, “Written Directives,” and in 10 CFR 35.3045, “Medical Event Reporting.” As directed by 

the Commission in SRM-M090625B, “Meeting with Advisory Committee on the Medical Uses of 

Isotopes (ACMUI), 1:30 p.m., Thursday, June 25, 2009,” dated July 1, 2009, the staff worked 

closely with the Advisory Committee on the Medical Uses of Isotopes (ACMUI) and the broader 

medical and stakeholder community in developing these recommendations. The 

recommendations include changing from a dose-based criterion for assessing whether a 

medical event (ME) has occurred, to a hybrid definition using both dose-based and sourcestrength based criteria, which is in accordance with recommendations by the ACMUI and input 

received from most stakeholders. 

CONTACT: Ronald E. Zelac, FSME/MSSA 

 (301) 415-7635 

 
The Commissioners 2 

BACKGROUND: 

In SECY-05-0234, dated December 27, 2005, the staff recommended that the Commission 

approve the staff’s plan to revise the ME definition and the associated requirements for written 

directives (WDs) to be activity-based, instead of dose-based. In SRM-SECY-05-0234, dated 

February 15, 2006, the Commission directed the staff to proceed directly with the development 

of a proposed rule to modify both the WD requirements in 10 CFR 35.40(b)(6) and the ME 

reporting requirements in 10 CFR 35.3045 for permanent implant brachytherapy medical use, to 

convert from dose-based to activity-based ME criteria. In SRM–SECY-08-0080, dated July 25, 

2008, the Commission approved publication of a proposed rule to amend 10 CFR Part 35 

sections involving reporting and notification of MEs and also to clarify requirements for 

permanent implant brachytherapy. 

The proposed rule was published in the Federal Register on August 6, 2008 (73 FR 45635) for 

public comment. The vast majority of commenters offered no objection to conversion from 

dose-based to activity-based ME criteria. During late summer and early fall of 2008, a 

substantial number of MEs involving permanent implant brachytherapy were reported to the 

U.S. Nuclear Regulatory Commission (NRC). Based on its evaluation of this information, the 

staff believed that a number of these MEs would not be categorized as MEs under the proposed 

rule. This would be inconsistent with the original regulatory intent because the staff had 

previously been directed to clarify the requirements for reporting of MEs involving permanent 

implant brachytherapy so that licensees would be able to identify MEs more easily and in a 

more timely manner. The intent was also not to adversely impact the detection of significant 

errors as MEs. Additionally, the evaluation of the circumstances and data from the MEs 

reported in 2008 prompted the staff to reevaluate the regulations related to training 

requirements and time frames for licensees to assess the dose to the treatment site for 

permanent implant brachytherapy. To assist in this effort, the NRC requested that the ACMUI 

reconsider the issue and draft a report to provide recommendations on regulatory changes or 

improvements to the NRC’s processes for permanent implant brachytherapy programs. 

The proposed rule language and rationale were modified and in SECY-10-0062, “Reproposed 

Rule: Medical Use of Byproduct Material – Amendments/Medical Event Definitions,” dated 

May 18, 2010, the staff recommended that a revised proposed rule be published for public 

comment. In SRM-SECY-10-0062, dated August 10, 2010, the Commission disapproved the 

staff’s recommendation. Instead, the Commission directed the staff to work closely with the 

ACMUI and the broader medical and stakeholder community to develop event definitions that 

would protect the interests of patients, allow physicians the flexibility to take actions that they 

deem medically necessary, while continuing to enable the agency to detect failures in process, 

procedure, and training, as well as any misapplication of byproduct materials by authorized 

users (AUs). 

Additionally, the SRM directed staff to hold a series of stakeholder workshops to discuss issues 

associated with the ME definition. These facilitated workshops (with webinar capability) were 

held in New York, New York, in June 2011 and in Houston, Texas, in August 2011.1,2 The 

 

1

 Meeting summaries are available in the NRC’s Agencywide Documents Access and Management 

System (ADAMS) at Accession Numbers ML111930470 and ML112510385, respectively. 

2

 Panelists represented the ACMUI, the Agreement States, licensees (specifically, the Veterans 

Administration), professional organizations (specifically, the American Society for Radiation Oncology, 

[ASTRO]), patient rights advocates, and NRC staff.
The Commissioners 3 

nearly unanimous position expressed at both of the meetings was that the ME criterion for the 

treatment site should be source-strength based (i.e., activity-based), rather than dose-based. 

Finally, the SRM directed the staff to provide the Commission with an Integrated Plan (IP), 

denoting schedule and Agreement States participation, for completing this rulemaking, along 

with other activities in the medical area. The requested IP was conveyed to the Commission, 

for information, in March 2011 as Enclosure 1 to SECY-11-0035, “Integrated Plan, Title 10 of 

the Code of Federal Regulations Part 35, ‘Medical Use of Byproduct Material,’ Activities and 

Options for Streamlining the Medical Rulemaking Petition and Rulemaking Processes.” 

The ACMUI Permanent Implant Brachytherapy Subcommittee (PIBS) issued its report, which 

was unanimously approved by the ACMUI at its October 20, 2010, meeting (ML103540385). 

The PIBS report included the caveat that it was to be considered as an interim report that might 

be revised in the future in response to additional input, such as that expected to be received 

from stakeholders at the then-upcoming public workshops. The following ACMUI meeting, in 

April 2011 was devoted to issues associated with the ME definition and was webcast, providing 

opportunity for public involvement on this issue.3

 

 

The ACMUI final report on prostate brachytherapy regulation was provided to the NRC staff 

following the ACMUI October 18, 2011, teleconference public meeting (ML11292A139). The 

final report reflected the principal positions expressed and recommendations provided by 

participants during the NRC public workshops. In particular, the recommendations reflected a 

change from dose-based ME criteria for the treatment site to source-strength based criteria. The 

report significantly revised the earlier interim report. For example, the final report no longer 

included the interim report recommendation to replace the term “treatment site” with different, 

contemporary nomenclature. The final report also does not include two sets of regulations to 

separate procedures that result in significant rearrangement of implant locations during the 

completion of surgical procedures from those procedures that do not generally result in this 

phenomenon. The final report did include a quantitative metric, the “octant approach,” for 

determining that a distribution of implanted seeds was irregular enough (i.e., demonstrating 

“bunching”) to consider the treatment as an ME. The final report also included a dose-related 

ME criterion for the treatment site. 

By letter to the Chairman of the ACMUI dated November 30, 2011,4

 the American Society for 

Radiation Oncology (ASTRO) expressed criticism of the ACMUI final report. ASTRO 

considered the ME definition recommended by the ACMUI to be complex, difficult to regulate, 

and likely to cause confusion in practice. Consequently, a revised final report5

 that simplified 

the ME criteria for the treatment site, removing the “octant approach” and direct reference to 

absorbed dose, was issued by the PIBS. The revised final report was, with minor modification, 

approved by the ACMUI during its February 7, 2012, teleconference public meeting and was 

subsequently, in a letter to the Chairman of the ACMUI,6 characterized by ASTRO as an 

improvement. 

 

3

 Transcript available at www.nrc.gov. 

4

 ML11341A051, “LTR-11-0639 - Ltr. Laura Thevenot re: Definition of Medical Event.” 

5

 ML12038A279, “Advisory Committee on the Medical Uses of Isotopes (ACMUI) Permanent Implant 

Brachytherapy Revised Final Report.” 

6

 ML12044A358, “Ltr frm American Society for Radiation Oncology (ASTRO) to Dr. Leon Malmud dtd 

02/13/12 RE: Reconsideration of Advisory Committee on the Medical Uses of Isotopes (ACMUI) 

Permanent Implant Brachytherapy Subcommittee Recommendations.” 
The Commissioners 4 

The “expanded” rulemaking to amend Part 35 began in July 2010 and is currently ongoing. It is 

anticipated that a regulatory basis for modifying the Part 35 requirements for WDs and reporting 

MEs involving permanent implant brachytherapy will be completed after receipt of an SRM for 

this paper, and these modifications will then be ready for inclusion in the ongoing “expanded” 

Part 35 rulemaking. 

DISCUSSION: 

The staff used the recommendations in the ACMUI revised final report, along with the 

substantial input from stakeholders who participated in the facilitated public workshops and in 

ACMUI public meetings to develop the recommendations in this paper.7

 Based on the input 

received from the medical community and other stakeholders on this issue, the staff believes 

that these recommendations, which include changing from dose-based ME criteria for the 

treatment site to source-strength based criteria, would protect the interests of patients and allow 

physicians the flexibility to take actions that they deem medically necessary, while continuing to 

enable the agency to detect failures in process, procedure, and training, as well as any 

misapplication of byproduct materials by AUs. 

Based on a survey conducted prior to the 2011 public workshops, the Agreement States are 

generally not supportive of the main objective of the rule revision being proposed, i.e., to change 

from a dose-based ME criterion to a source-strength ME criterion for the treatment site for 

permanent implant brachytherapy use. This position of the Organization of Agreement States 

(OAS) was presented during the two facilitated public workshops and was formally conveyed to 

NRC in a letter from the OAS Executive Board (Board) dated February 27, 2012.8

 In its letter, 

the OAS Board did not oppose the introduction of the proposed source-strength based ME 

criterion for the treatment site, but recommended that dose-based criteria also be retained, for 

consistency with ME criteria for other medical uses. This position, however, has been opposed 

by all other stakeholders from whom NRC has received input, who assert that dose-based ME 

criteria for the treatment site limit the physician AU’s ability to provide optimum care and could 

also result in many inappropriately identified MEs. 

Also in its letter, the OAS Board recommended that for the proposed dose-based ME criteria for 

normal tissue structures, the dose thresholds for ME reporting be established by the AU for 

each treatment being provided, rather than through regulation. This is essentially what the 

ACMUI recommended and proposed as the ME reporting criterion for normal tissue structures 

located within the treatment site, for which the AU specifies the expected/intended absorbed 

dose in the pre-implant-approved dose distribution and for which the threshold for reporting an 

ME is a pre-set percentage of this expected/intended absorbed dose (see Enclosure). For 

normal tissue structures located adjacent to the treatment site, the proposed dose-based 

criterion for ME reporting would be indirectly established by the AU through prescribing an 

intended absorbed dose to the treatment site. The threshold for reporting an ME would be a 

pre-set percentage of this intended absorbed dose (see Enclosure). No other stakeholders, 

from which NRC received input on this issue, had objections to the pre-set percentage approach 

nor the values recommended. 

 

7

 Note that the staff recommendations for modifying the WD requirements and ME criteria, which follow, 

reflect the widely-based stakeholder position that MEs should only reflect circumstances in which there is 

actual or potential harm to patients being treated. 

8

 ML12072A330, “OAS Board Position on Pre-Decisional Draft of Recommendations on Regulatory 

Changes for Permanent Implant Brachytherapy Programs.” 
The Commissioners 5 

A recommendation from ASTRO, incorporated into the ACMUI revised final report but not 

incorporated into staff’s recommended ME criteria, involves possible “bunching” of implanted 

radioactive seeds in the treatment site, instead of being distributed as the AU had planned 

before the start of the procedure. ASTRO recommended that the AU affirm in writing on the 

WD, after the implant is completed, that the distribution of the sources within the treatment site 

was as intended per the pre-implant WD.1

 The staff believes that appropriate regulation for 

patient protection from undeclared or unrecognized “bunching” exists through two current 

requirements, and the AU affirmation would be unnecessary.9

 

Specifically, 10 CFR 35.40(b)(6) requires completion of the written directive after the 

implantation. This affords the AU an opportunity to acknowledge any seed “bunching” that may 

have been done intentionally or that may have been unavoidable10. In either case, the 

physician now has the opportunity to initiate follow up medical remediation, if deemed 

appropriate. 

Additionally, 10 CFR 35.41, “Procedures for Administrations Requiring a Written Directive,” 

requires licensees to develop, implement, and maintain written procedures to provide high 

confidence that, among other things, each administration is in accordance with the written 

directive and, if applicable, with the treatment plan. To accomplish this objective, these written 

procedures must include conducting post-implant assessment of each implant procedure. 

“Bunching” that is not declared and explained in the completed WD10 would become apparent 

through this assessment, and follow up medical remediation could be considered. 

Moreover, as noted above, this paper includes a recommended ME criterion involving absorbed 

doses to normal tissue structures. In order to evaluate the doses to normal tissues and 

structures, or at least to assess whether variances from expected results (including absorbed 

doses) are significant, imaging to determine the positions/locations of the implanted sources 

would be essential. “Bunching” that is not declared and explained in the WD would become 

apparent, and follow up medical remediation could be considered. Therefore, the staff believes 

that an ME criterion for the treatment site that is based on the ASTRO recommendation for an 

AU attestation as to the acceptability of the distribution of sources within the treatment site is 

unnecessary for patient protection from unintentional and unrecognized seed “bunching.” 

The regulatory basis to be developed for rulemaking will be based on the staff 

recommendations contained in this paper, as directed by the Commission. A Commission 

meeting is being scheduled to hear and discuss these staff recommendations, as well as 

medical community views of these recommendations. Consequently, the staff recommends that 

this notation vote paper be released for public review prior to the Commission meeting. 

RECOMMENDATIONS: 

The staff recommends that the Commission approve the following recommendations for 

modifying the regulatory requirements that appear in 10 CFR 35.3045 for permanent implant 

brachytherapy ME reporting, as discussed in the Enclosure. 

 

9

 See the minority report in the ACMUI revised final recommendations at ML12019A196. 

10 As specified in the WD a) by design for preservation of normal tissue or, b) for intentional dose 

escalation to a particular region or c) for cases in which patient anatomy or technical limitations preclude 

physically reaching certain areas. 
The Commissioners 6 

• Define separate ME criteria exclusively for permanent implant brachytherapy utilizing 

radioactive seeds, for all treatment sites. 

• For the treatment site, an ME will have occurred1110if 20 percent or more of the implanted 

seeds are located outside of the intended implant location. 

• For normal-tissue structures, an ME will have occurred11 if: a) for neighboring structures 

(such as the bladder or rectum in prostate implants as an example), the dose to at least 

5 contiguous cm3

 exceeds 150 percent of the absorbed dose prescribed to the treatment 

site; or b) for intra-target normal structures (such as the urethra in prostate implants as 

an example), the absorbed dose to at least 5 contiguous cm3

 exceeds 150 percent of 

that structure’s expected absorbed dose based on the approved pre-implant dose 

distribution. These dose determinations are to be made within a time frame to be 

determined by the AU consistent with prevailing medical practice, but not to exceed 60 

days unless accompanied by written justification. 

• An ME will have occurred if a treatment is administered: a) using the wrong 

radionuclide; b) using the wrong activity or source strength (+/-20%) as specified in the 

WD; c) with delivery to the wrong patient; d) with seeds implanted directly into the wrong 

site or body part, i.e. into other (distant from the treatment site) locations; e) with delivery 

using the wrong modality; or f) using leaking sources. 

The staff notes that the current WD requirements for brachytherapy in 10 CFR 35.40(b)(6) 

would require only minor modification to conform with the recommended modifications to 10 

CFR 35.3045, listed above, for permanent implant brachytherapy. These modifications, as 

discussed in the Enclosure, are summarized as follows: 

• Define separate WD criteria exclusively for permanent implant brachytherapy utilizing 

radioactive seeds, for all treatment sites. 

• Delete “total dose” as an option for completion of the WD, leaving the other option, “total 

source strength and exposure time,” as the required entry field (along with entry fields for 

radionuclide, treatment site, and number of sources). 

• Replace “before completion of the procedure” with “before the patient is released from 

the AU’s control and leaves the post-procedure recovery area.” (As recommended by 

the ACMUI in its final and revised final reports12, to remove uncertainty that has been 

encountered in interpretation of the existing requirement.) 

 

11 With exceptions for seed migration, edema and other patient-related factors, or source displacement 

following placement, as long as the criterion is not violated. 

12 ML11292A139 and ML12038A279, respectively. 
The Commissioners 7 

COORDINATION: 

The Office of the General Counsel has reviewed this paper, and has no legal objection. 

In accordance with Policy & Procedure 2-5, “FSME Procedure for Interacting with the Advisory 

Committee on the Medical Uses of Isotopes during Development of Major Medical Policy 

Issues,” the staff has engaged the ACMUI on the recommendations in this paper for modifying 

the Part 35 requirements for WDs and reporting MEs involving permanent implant 

brachytherapy. The ACMUI had an opportunity to review this paper, and its views are reflected 

in this paper. 

 /RA Michael F. Weber for/ 

R. W. Borchardt 

Executive Director 

 for Operations 

Enclosure: 

Recommended Changes, Permanent Implant 

 Brachytherapy Regulatory Program 
The Commissioners 7 

COORDINATION: 

The Office of the General Counsel has reviewed this paper, and has no legal objection. 

In accordance with Policy & Procedure 2-5, “FSME Procedure for Interacting with the Advisory 

Committee on the Medical Uses of Isotopes during Development of Major Medical Policy 

Issues,” the staff has engaged the ACMUI on the recommendations in this paper for modifying 

the Part 35 requirements for WDs and reporting MEs involving permanent implant 

brachytherapy. The ACMUI had an opportunity to review this paper, and its views are reflected 

in this paper. 

 /RA Michael F. Weber for/

R. W. Borchardt 

Executive Director 

 for Operations 

Enclosure: 

Recommended Changes, Permanent Implant 

 Brachytherapy Regulatory Program 

ADAMS Accession No.: ML12072A306 WITS200900138 /EDATS: SECY-2009-0334

OFC RMSB/MSSA RMSB/MSSA RMSB/MSSA DD: MSSA D: MSSA 

NAME RZelac MFuller CEinberg PHenderson BMcDermott 

DATE 02/28/12 03/6/12 03/6/12 03/21/12 03/22/12 

OFC OGC TechEd D: FSME EDO 

NAME BJones CPoland MSatorius RWBorchardt 

(MWeber for) 

DATE 03/19/12 03/28/12 03/30/12 04/5/12 

OFFICIAL RECORD COPY