Draft Regulatory Analysis for Proposed Rule - 10 CFR Part 35

Draft Regulatory Analysis for Proposed Rule, 10 CFR Part 35, Medical Use of Byproduct Materials.pdf

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Draft Regulatory Analysis for Proposed Rule - 10 CFR Part 35

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Draft Regulatory Analysis for Proposed Rule:
Amendments to Medical Use of Byproduct Material
Regulations (10 CFR Parts 30, 32, and 35)

U.S. Nuclear Regulatory Commission
Office of Federal and State Materials and Environmental
Management Programs
Division of Intergovernmental Liaison Rulemaking
XXXX 2013

Draft Regulatory Analysis

Page i

Table of Contents
Executive Summary ...................................................................................................................... ii
Acronyms ..................................................................................................................................... iv
1.
Statement of the Problem and Objective of the Rulemaking....................................... 1
2.
Identification and Preliminary Analysis of Alternative Approaches .............................. 2
2.1
Option 1: No Action .................................................................................................... 2
2.2
Option 2: Amend 10 CFR Parts 30, 32, and 35.......................................................... 2
3.
Estimation and Evaluation of Benefits and Costs ........................................................ 8
3.1
Identification of Affected Attributes .............................................................................. 8
3.2
Analytical Methodology ............................................................................................... 9
3.3
Detailed Results ........................................................................................................ 14
4.
Presentation of Results ............................................................................................. 40
4.1
Benefits and Costs .................................................................................................... 40
4.2
Backfitting .................................................................................................................. 41
5.
Decision Rationale .................................................................................................... 41
6.
Implementation .......................................................................................................... 42
7.
References ................................................................................................................ 42
Appendix A: Regulatory Flexibility Analysis ............................................................................... 44
Appendix B: Assumptions by section determining impacted NRC licensees. ............................ 47

Draft Regulatory Analysis

Page ii

Executive Summary
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend Parts 30, 32, and 35 of
Title 10 of the Code of Federal Regulations (10 CFR) related to medical use of byproduct
material. In this action the NRC addresses three ongoing rulemaking projects and several other
related topics. First, this rule proposes amendments to the reporting and notification
requirements for a medical event (ME) for permanent implant brachytherapy. Second, the rule
proposes changes: (1) to the training and experience (T&E) requirements for authorized users
(AUs), medical physicists, Radiation Safety Officers (RSOs), and nuclear pharmacists; (2) to the
requirements for measuring molybdenum contamination and reporting of failed technetium and
rubidium generators, and (3) to allow Associate Radiation Safety Officers (ARSOs) to be named
on a medical license. Third, the rule proposes changes to address a request filed in a petition
for rulemaking (PRM) (PRM-35-20) to exempt certain board-certified individuals from certain
T&E requirements (i.e., “grandfather” these individuals) so that they may be identified on a
license or permit for materials and uses that they performed on or before October 24, 2005, the
expiration date of the former Subpart J of Part 35 which contained the prior T&E requirements.
Currently there are 1,083 NRC and 6,390 Agreement State medical licensees that would be
affected by this proposed rulemaking. Existing guidance documents (NUREG-1556, Volumes 9
and 13) would be revised to reflect these changes.
This regulatory analysis examines the benefits and costs of the proposed changes to these
regulations. The analysis makes the following key findings:
•

Cost to Industry. The proposed rule would result in a total one-time cost to the Industry
of approximately $8.3 million followed by total annual costs of approximately $775,000.
This results in costs of approximately $1,000 per licensee in one-time cost and
approximately $100 per licensee in annual cost.

•

Costs to the NRC. The proposed rule would result in a one-time cost to the NRC of
approximately $400,000 followed by an annual savings of approximately $75,000.

•

Cost to the Agreement States. The proposed rule would result in a one-time cost to the
Agreement States of approximately $5.1 million followed by an annual savings of
approximately $325,000.

•

Decision Rationale. The NRC has determined that the proposed rule is cost-justified
because the proposed regulatory initiatives would potentially reduce unnecessary
radiation exposure to patients. Additionally, the proposed rule would update, clarify, and
strengthen the existing regulatory requirements, and thereby promote public health and
safety. Cost reductions would be realized by removing attestation requirements for
certain board certified individuals, by modifying ME reporting criteria to ensure only
significant events need to be reported, and by other proposed modifications to the
regulations.

•

The NRC evaluated the impact that a small entity would be expected to incur as a result
of the rule. The proposed rule would have an average implementation cost of
approximately $1,000 per licensee and an annual cost impact of an estimated $100 per

Draft Regulatory Analysis

Page iii

licensee. Thus, even though the proposed rule would affect a substantial number of
licensees that are small entities, it would not have a significant economic impact on
these entities.

Draft Regulatory Analysis

Acronyms
ACMUI
ADAMS
AMP
ANP
ARSO
AU
CFR
FR
FTE
ME
Mo-99
NRC
OMB
PRM
Rb-82
RSO
SRM
SSDR
Sr-82
Sr-85
Tc-99m
T&E
WD

Advisory Committee on the Medical Uses of Isotopes
Agencywide Documents Access and Management System
Authorized medical physicist
Authorized nuclear pharmacist
Associate Radiation Safety Officer
Authorized user
Code of Federal Regulations
Federal Register
full-time equivalent
medical event
molybdenum-99
U.S. Nuclear Regulatory Commission
Office of Management and Budget
petition for rulemaking
rubidium-82
Radiation Safety Officer
Staff Requirements Memorandum
Sealed Source and Device Registry
strontium-82
strontium-85
technetium-99m
training and experience
written directive

Page iv

Draft Regulatory Analysis
1.

Page 1

Statement of the Problem and Objective of the Rulemaking

The NRC is proposing to amend Parts 30, 32, and 35 of 10 CFR related to the medical use of
byproduct material. Medical use regulations in 10 CFR Part 35 were revised in their entirety in
April 2002 (67 FR 20250). The T&E requirements in Part 35 were further revised through an
additional rulemaking published in the Federal Register (70 FR 16336) on March 30, 2005.
In implementing the regulations, the NRC staff, stakeholders, and the Advisory Committee on
the Medical Uses of Isotopes (ACMUI) have identified numerous issues that need to be
addressed through the rulemaking process.
In Staff Requirements Memorandum (SRM) dated May 15, 2008, entitled “Meeting with Advisory
Committee on the Medical Uses of Isotopes (ACMUI), 1:30 p.m., Tuesday April 29, 2008,”
(Agencywide Documents Access and Management System (ADAMS) Accession No.
ML081360319), the Commission directed the staff to work with the ACMUI and the Agreement
States to provide recommendations to the Commission with regard to amending the NRC’s
requirements for preceptor attestation for both board certified individuals and for individuals
seeking authorization via an alternate pathway. The staff was also directed to consider
additional methods, such as the attestation being provided by consensus of an authoritative
group.
Additionally, the Commission directed the staff in SRM-SECY-10-0062, dated August 10, 2010
(ADAMS Accession No. ML102220233), to work closely with the ACMUI and the medical
community to develop event definitions for permanent implant brachytherapy that would protect
the interests of patients, and 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 processes, procedures and training.
The amendment would establish separate ME criteria for permanent implant brachytherapy in
terms of the total source strength administered (activity-based) rather than the dose delivered
(dose-based). The ME criteria would also include absorbed doses to normal tissues located
outside of the treatment site and those located within the treatment site. Other changes include
amending preceptor attestation requirements, allowing ARSOs to be named on a medical use
license, changing the requirements for measuring molybdenum contamination and reporting of
failed technetium and rubidium generators, extending the 5-year inspection frequency for a
gamma stereotactic radiosurgery unit to 7 years, and several clarifying amendments.
The proposed rulemaking would also consider issues that were raised in a petition for
rulemaking (PRM-35-20, ADAMS Accession No. ML062620129) filed by E. Russell Ritenour,
Ph.D., on behalf of the American Association of Physicists in Medicine on September 13, 2006.
The petition requested that the training requirements for experienced RSOs and medical
physicists in 10 CFR 35.57 be amended to recognize board certified physicists and RSOs as
“grandfathered” for the modalities that they practiced as of October 24, 2005.
The proposed rule addresses the petition and Commission direction to clarify the current
regulations, provides greater flexibilities to licensees, revises medical event criteria for
permanent implant brachytherapy without compromising patient, worker, and public health and
safety.

Draft Regulatory Analysis

Page 2

This analysis presents background material, rulemaking objectives, alternatives considered,
input assumptions, analysis of the costs and benefits of the proposed rule, and decision
rationale. It describes the consequences of the rule language and alternative approaches
necessary to accomplish the regulatory objectives.
2.

Identification and Preliminary Analysis of Alternative Approaches

The following sections describe the two regulatory options that the NRC is considering to meet
the rulemaking objective identified in section 1.1. Section 3 presents a detailed cost and benefit
analysis.
2.1

Option 1: No Action

Under Option 1, the no-action alternative, the NRC would not amend the current regulations in
10 CFR Parts 30, 32, and 35.
Option 1 would avoid costs and savings that the proposed rule would impose; however, the
benefits from updating, clarifying, and consolidating the current requirements to enhance the
current level of protection for public health and safety would not be realized. Also, there would
be no changes made to improve regulatory efficiency and the resulting benefits to the medical
use of byproduct material. Option 1, which is the no-action alternative, is the baseline for this
regulatory analysis.
2.2

Option 2: Amend 10 CFR Parts 30, 32, and 35

The changes listed below are consistent with Option 2 to revise 10 CFR Parts 30, 32, and 35
and would result in incremental increase or decrease in cost or benefit.
Section 30.34(g). This new requirement would be added to require licensees to report to the
NRC the results of any test of generator elutions for molybdenum-99 (Mo-99) breakthrough or
strontium-82 (Sr-82) and strontium-85 (Sr-85) contamination that exceeds the permissible
concentration listed in § 35.204(a). Reporting would be in accordance with the reporting and
notifications in § 35.3204. While this proposed reporting requirement as well as testing every
elution is new, the requirement for licensees to test the first elution to ensure that it does not
exceed the permissible concentration listed in § 35.204(a), and record the results of these tests,
is already in current regulations. On several occasions in 2006, 2007, and 2008, medical
licensees voluntarily reported to the NRC that generators had failed the Mo-99 breakthrough
tests. In 2011, contamination issues were reported with Sr-82 rubidium-82 (Rb-82) generators.
Because the reporting was voluntary, the NRC had difficultly determining the extent of the
issues and the underlying cause. Breakthrough of Mo-99 and contamination of Sr-85 may lead
to unnecessary exposure to radiation for patients. The proposed change would allow the NRC
to assess the situation quickly and efficiently when issues occur with generators that may cause
unwarranted radiation exposure to patients.
Section 30.50 (b)(5). This new paragraph would be added to require manufacturers or
distributors of medical generators to notify the NRC within 24 hours when they receive a
notification required by § 35.3204(a). Section 35.3204(a) requires licensees to notify the
manufacturer or distributor of the generator when an eluate from a generator exceeds the

Draft Regulatory Analysis

Page 3

permissible concentration listed in § 35.204(a). On several occasions in 2006, 2007 and 2008,
eluates from generators exceeded the permissible concentration listed in § 35.204(a). Current
regulations do not require manufacturers and/or distributors to notify the NRC of these incidents.
This hindered the NRC’s efforts to determine the extent of the issues, which in turn caused a
delay in the NRC’s ability to take action to protect medical patients from receiving unnecessary
exposure to radiation. Reporting the incidents to the NRC within 24 hours would allow for
interim actions to be taken quickly to protect patients while the causes and corrections of the
issues are being determined.
Section 35.12 (b)(1). This paragraph would be amended to remove the requirement to submit
additional copies of NRC Form 313 when applying for a license. The proposed change would
relieve cost to the licensees by requiring less paperwork to be submitted. This paragraph would
also add a requirement to submit information on an individual seeking to be identified on a
license as an ARSO or as an ophthalmic physicist.
Section 35.12 (c)(1). This paragraph would be amended to remove the requirement to submit
an additional copy of NRC Form 313 or a letter containing information required by NRC Form
313 for license amendments or renewals. This change would relieve cost to the licensees by
requiring less paperwork to be submitted.
Section 35.13(d). This new paragraph would require a licensee to apply for and receive a
license amendment prior to permitting an individual to work as an ARSO or before the RSO
assigns different tasks and duties to an ARSO who is authorized on the license. The NRC
determined that allowing ARSOs to be named on a license would increase the number of
individuals who would be available to serve as preceptors for individuals seeking to be
appointed as RSOs or ARSOs. Also, by being named on a license, ARSOs could more easily
become RSOs on other licenses for the types of uses for which they qualify.
Section 35.13(i). This new paragraph would allow licensees who are authorized for manual
brachytherapy to receive certain sealed sources without seeking a license amendment.
Specifically, a licensee would be able to receive sealed sources from a new manufacturer or a
new model number for a sealed source listed in the Sealed Source and Device Registry (SSDR)
used for manual brachytherapy for quantities and isotopes already authorized by its license.
This change is proposed to make it easier for the licensee to obtain the appropriate sealed
sources necessary for patient treatments in a timely manner.
Section 35.14(a). This paragraph would be amended to remove the requirement to obtain a
written attestation for those individuals who are certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State when using the notification
process.
Section 35.14(b)(1). This paragraph would be amended to require a licensee to notify the
Commission within 30 days after an ARSO or ophthalmic physicist has a name change or
discontinues performance of their duties under the license.
Section 35.14(b)(6). This new paragraph would require a licensee to notify the NRC no later
than 30 days after receiving a sealed source from a new manufacturer or a new model number

Draft Regulatory Analysis

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listed in the SSDR for manual brachytherapy for quantities and isotopes already authorized by
the license.
Section 35.24(b). This paragraph would be modified to allow the licensee’s management to
appoint one or more qualified individuals to serve as ARSOs. These appointed ARSOs would
have to be currently identified on a medical license or permit for the types of use of byproduct
material for which the RSO would assign tasks and duties. Each ARSO would have to agree in
writing to the tasks and duties assigned by the RSO.
Section 35.41(b)(5). This new paragraph would require licensees to add procedures for any
administrations requiring a WD to determine if an ME as defined in § 35.3045 has occurred.
Section 35.41(b)(6). This new paragraph would require licensees to add procedures for
permanent implant brachytherapy that include a procedure for determining dose/activity
parameters within 60 calendar days from the date the implant was performed. If the licensee
cannot make these determinations within the 60 calendar days because of the patient not being
available, then the licensee must justify the reason for not making these determinations in
writing.
Section 35.50(a). For individuals seeking to be named as an RSO or an ARSO, this paragraph
would be amended to remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State.
Section 35.50(c)(3). This new paragraph would allow an individual who is qualified to be an
AU, but is not named as an AU on a medical license or permit, to be named simultaneously as
the RSO and the AU on the same new medical license. Under current § 35.50(c)(2), an AU
identified on a medical license or permit can be named as the RSO for the same byproduct
material for which the AU is authorized. This new provision would expand this principle and
allow an individual who is qualified to be the AU, but is not named on a medical license or
permit, to be named simultaneously as both the AU and the RSO for the same uses on a new
medical license. The provision would make it easier for an individual qualified to be an AU to
open a physician’s office or a clinic and make medical procedures more widely available,
especially in rural areas.
Section 35.51(a). This paragraph would be amended to remove the requirement for individuals
seeking to be named as an authorized medical physicist (AMP) to obtain a written attestation for
those individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State.
Section 35.55(a). This paragraph would be amended to remove the requirement for individuals
seeking to be named as an authorized nuclear pharmacist (ANP) to obtain a written attestation
for those individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State.
Section 35.57(a)(1). This paragraph would be modified to add AMPs and ANPs identified on a
Commission or an Agreement State license or a permit issued by a Commission or an
Agreement State broad scope licensee or master material license permit or by a master material

Draft Regulatory Analysis

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license permittee of broad scope on or before October 24, 2005, as individuals that would not
need to comply with the training requirements of §§ 35.50, 35.51, or 35.55, respectively.
Section 35.57(a)(2). This paragraph would be modified to recognize individuals certified by the
named boards in the now removed subpart J of Part 35 on or before October 24, 2005, who
would not need to comply with the training requirements of § 35.50 to be identified as a RSO on
a Commission or an Agreement State license or Commission master material license permit for
those materials and uses that these individuals performed on or before October 24, 2005.
Removal of subpart J from 10 CFR Part 35 was effective on October 24, 2005. Training
requirements excepted under this paragraph would be limited to those materials and uses these
individuals performed on or before October, 24, 2005. Individuals excepted by this paragraph
would still need to meet the recentness training requirements in § 35.59 and, for new materials
and uses, the training requirements in § 35.50(d).
Section 35.57(a)(3). This paragraph would be modified to recognize individuals certified by the
named boards in the now removed subpart J of 10 CFR Part 35 on or before October 24, 2005,
who would not need to comply with the training requirements of § 35.51 to be identified as an
AMP on a Commission or an Agreement State license or Commission master material license
permit for those materials and uses that these individuals performed on or before October 24,
2005. Removal of subpart J from 10 CFR Part 35 was effective on October 24, 2005. Training
requirements excepted under this paragraph would be limited to those materials and uses these
individuals performed on or before October, 24, 2005. Individuals excepted by this paragraph
would still need to meet the recentness training requirements in § 35.59 and, for new materials
and uses, the training requirements in § 35.51(c).
Section 35.57(b)(1). This paragraph would be amended to change the date from October 24,
2002, to October 24, 2005, for individuals named on a license as AUs because during the
3-year time frame, applicants could have qualified under the old Subpart J or the new T&E
requirements in subparts D through H of 10 CFR Part 35 to qualify as AUs. Additionally, the
paragraph would be amended to clarify that individuals authorized before, rather than just on,
October 24, 2005, would not be required to comply with the T&E requirements in subparts D
through H of 10 CFR Part 35 for those materials and uses that they performed on or before that
date.
Section 35.57(b)(2). This paragraph would be restructured and expanded to recognize
physicians, dentists, or podiatrists who were certified by the named boards in the now-removed
subpart J of Part 35 on or before October 24, 2005, who would not need to comply with the
training requirements of subparts D through H of 10 CFR Part 35 to be identified as an AU on a
Commission or an Agreement State license or Commission master material license permit for
those materials and uses that these individuals performed on or before October 24, 2005.
Section 35.65(b)(2). This new paragraph would prohibit the bundling or aggregating of single
sealed sources to create a sealed source with an activity larger than that authorized by § 35.65.
Sources that consist of multiple single sources greater than authorized by § 35.65 would be
treated as one single source and would have to meet all the regulatory requirements for that
single source including, if appropriate, listing on a specific medical license, leak testing, and
security requirements.

Draft Regulatory Analysis

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Section 35.190(a). This paragraph would be amended to remove the written attestation
requirement for a physician who is certified by a specialty board whose certification process has
been recognized by the NRC or an Agreement State and is seeking to be named as an AU for
byproduct material authorized under § 35.100.
Section 35.204(b). This paragraph has been modified to require licensees to measure the
Mo-99 concentration after each eluate from a Mo-99/Tc-99m generator. Generator
manufacturers recommend testing each elution prior to use in humans. Mo-99 breakthrough
measurements which exceed the permissible concentration listed in § 35.204(a) may cause
unnecessary radiation exposures to patients.
Section 35.204(e). This new paragraph would require licensees to report any measurement
that exceeded the limits specified in § 35.204(a) for Mo-99/Tc-99m and Sr-82 Rb-82 generators.
Although current regulations require licensees to measure Mo-99, Sr-82, and Sr-85
concentrations and record the results, there is no provision to report when a result exceeds the
regulatory limits. The new reporting requirement would provide information that would allow the
NRC to respond to the potential patient safety issue in a timely manner.
Section 35.290(a). This paragraph would be amended to remove the written attestation
requirement for a physician who is certified by a specialty board whose certification process has
been recognized by the NRC or an Agreement State and is seeking to be named as an AU for
byproduct material authorized under § 35.200.
Section 35.390(a). This paragraph would be amended to remove the written attestation
requirement for a physician who is certified by a specialty board whose certification process has
been recognized by the NRC or an Agreement State and is seeking to be named as an AU for
byproduct material authorized under § 35.300.
Section 35.392(a). This paragraph would be amended to remove the written attestation
requirement for a physician who is certified by a specialty board whose certification process has
been recognized by the NRC or an Agreement State and is seeking to be named as an AU for
the oral administration of sodium iodide I-131 requiring a WD in quantities less than or equal to
1.22 gigabecquerels (33 millicuries).
Section 35.394(a). This paragraph would be amended to remove the written attestation
requirement for a physician who is certified by a specialty board whose certification process has
been recognized by the NRC or an Agreement State and is seeking to be named as an AU for
the oral administration of sodium iodide I-131 in quantities greater than 1.22 gigabecquerels (33
millicuries) requiring a WD.
Section 35.433(a)(2). This paragraph would be amended to add the T&E requirements for an
ophthalmic physicist who is not an AMP but who could be involved with ophthalmic treatments
using strontium-90 sealed sources. These requirements are similar to the T&E requirements for
an AMP, but would include only the requirements related to brachytherapy programs. The
ophthalmic physicist would not need an attestation. This change would increase the number of
qualified individuals available to support the use of strontium-90 sources for ophthalmic
treatments. Often, AUs who work in remote areas do not have ready access to an AMP to
perform the necessary calculation to support the ophthalmic treatment. This change would

Draft Regulatory Analysis

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make the procedure involving use of strontium-90 sources for ophthalmic treatments available
to more patients located in remote areas.
Section 35.490(a). This paragraph would be amended to remove the written attestation
requirement for a physician who is certified by a specialty board whose certification process has
been recognized by the NRC or an Agreement State and is seeking to be named as an AU for
byproduct material authorized under § 35.400.
Section 35.610(d)(1). This paragraph would be amended and restructured to add a new
training requirement for use of remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units. This proposed amendment would require all individuals who
would operate these units to receive vendor operational and safety instructions prior to the first
use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that
affects the operation and safety of the unit.
Section 35.655(a). This paragraph would be amended to extend the time interval for fully
inspecting and servicing a gamma stereotactic radiosurgery unit from 5 years to 7 years.
Section 35.690(a). This paragraph would be amended to remove the written attestation
requirement for a physician who is certified by a specialty board whose certification process has
been recognized by the NRC or an Agreement State and is seeking to be named as an AU for
byproduct material authorized under § 35.600.
Section 35.2024(c)(1) and (2). This new paragraph would require the licensee to keep records
of each ARSO assigned under § 35.24(b) for 5 years after the ARSO is removed from the
license. These records would have to include the written document appointing the ARSO
signed by the licensee’s management, and each agreement signed by the ARSO listing the
duties and tasks assigned by the RSO under § 35.24(b).
Section 35.2041. This section is impacted due to the recordkeeping requirements of the added
procedures required in § 35.41(b)(5) and (6).
Section 35.3045(a)(2). In this amended section, separate criteria for reporting an ME for
permanent implant brachytherapy procedures are established. The new criteria are expected to
capture events that are clinically significant and would reduce the number of reportable MEs
related to permanent implant brachytherapy resulting in cost reduction in § 35.3045(c), (d), and
(e) related to event notification and follow-up reports.
Section 35.3045(c). The telephone reporting costs to the Agreement States and the NRC
would be reduced because the requirements for reporting an ME for permanent implant
brachytherapy are changed in § 35.3045(a)(2). The new requirements would not capture
events that are not of significance and would reduce the number of reportable MEs related to
permanent implant brachytherapy.
Section 35.3045(d). The written reporting costs to the Agreement States and the NRC would
be reduced because the requirements for reporting an ME for permanent implant brachytherapy
are changed in § 35.3045(a)(2). The new requirements would not capture events that are not

Draft Regulatory Analysis

Page 8

significant and would reduce the number of reportable MEs related to permanent implant
brachytherapy.
Section 35.3045(e). The licensee reporting costs to the physician and patients would be
reduced because the requirements for reporting an ME for permanent implant brachytherapy
are changed in § 35.3045(a)(2). The new requirements would not capture events that are not
significant and would reduce the number of reportable MEs related to permanent implant
brachytherapy.
The NRC has estimated the benefits and costs of this option, which are described in Sections 3
and 4 of this regulatory analysis, and has pursued Option 2 for the reasons discussed in
Section 5.
3.

Estimation and Evaluation of Benefits and Costs

This section describes the analysis that the NRC conducted to identify and evaluate the benefits
and costs of the two regulatory options. Section 3.1 identifies the attributes that the staff
expects the proposed rulemaking to affect. Section 3.2 describes how the benefits and costs
have been analyzed. Finally, Section 3.3 presents the detailed results of the projected benefits
and costs.
3.1

Identification of Affected Attributes

This section identifies the factors within the public and private sectors that the final rule is
expected to affect, using the list of potential attributes in Chapter 5 of NUREG/BR-0184,
“Regulatory Analysis Technical Evaluation Handbook,” issued January 1997, and in Chapter 4
of NUREG/BR-0058, “Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory
Commission,” Revision 4, issued September 2004. This evaluation considered each attribute
listed in Chapter 5 of NUREG/BR-0184. The basis for selecting those attributes is presented
below.
Affected attributes include the following:
•

Industry Implementation - Under the proposed action, the industry would incur a
one-time cost to implement the proposed rule.

•

NRC Implementation - Under the proposed action, the NRC would develop the proposed
rule package to be published by the Office of the Federal Register and prepare the final
rule package that responds to comments from stakeholders and sets forth the final rule
text for publication by the Office of the Federal Register. The NRC would revise
guidance and inspection procedures to accommodate the requirements that would be
added or modified by the rulemaking process.

•

Industry Operations - The proposed changes to 10 CFR Parts 30, 32, and 35 would
require licensees to meet the new and amended requirements discussed in Section 2.2.

•

NRC Operations - The proposed changes would require the NRC to process and review
submitted licensing amendments and reports.

Draft Regulatory Analysis

Page 9

•

Other Government - The Agreement States would incur an implementation cost to issue
compatible regulatory requirements and guidance. The Agreement States would incur
annual operational cost as well.

•

Regulatory Efficiency - The action would result in enhanced regulatory efficiency through
regulatory and compliance improvements.

•

Public Health (routine) - Several proposed amendments would reduce the potential
radiation exposure to patients.

Attributes that the rulemaking options would not affect include the following: occupational health
(routine), occupational health (accidents), public health (accidents), environmental
considerations, general public, safeguards and security considerations, improvements in
knowledge, offsite property, onsite property, antitrust considerations, and other considerations.
3.2

Analytical Methodology

This section describes the methodology used to analyze the benefits and costs associated with
the proposed rule. The benefits include any desirable changes in the affected attributes. The
costs include any undesirable changes in the affected attributes.
As described in Section 3.1, the attributes expected to be affected include the following:
•
•
•
•
•
•
•

Industry Implementation
Industry Operation
NRC Implementation
NRC Operations
Regulatory Efficiency
Other Government
Public Health (routine)

The analysis evaluates several attributes on a quantitative basis. Quantitative analysis requires
a baseline characterization, including factors such as the number of licensees affected, the
nature of activities being conducted, and the types of new activities that licensees would
implement as a result of the rule. The analysis proceeds quantitatively for these attributes by
making general assumptions. Sections 3.2.1 – 3.3 describe the most significant analytical data
and assumptions used in the quantitative analyses of these attributes.
The proposed rule includes changes that affect attributes in a positive but not easily quantifiable
manner. For example, the attribute of Regulatory Efficiency would be enhanced by the
proposed changes made in requirements for submitting an application for a license such as in
§ 35.50. In this section, the regulations would be changed to make it easier for a physician to
open an office by allowing this individual to be the AU and the RSO on the same license
application.
One way public health (routine) would be positively affected is by reducing the potential for
unnecessary radiation exposure to patients with the changes to § 35.204. This section would

Draft Regulatory Analysis

Page 10

require licensees to test each eluate from a generator rather than just the first eluate. In the
past several years, generators have had breakthrough issues that have resulted in unnecessary
radiation exposure to patients.
The NRC’s input assumptions used data and information from NRC workgroups, staff
experience, and the NRC’s databases to estimate the costs associated with implementation,
and the costs associated with annual operations of industry and the NRC.
In accordance with guidance from the Office of Management and Budget (OMB) and
NUREG/BR-0058, Revision 4, this regulatory analysis presents the results of the analysis using
both 3 percent and 7 percent real discount rates. The real discounted rates or present-worth
calculation simply determines how much society would need to invest today to ensure that the
designated dollar amount is available in a given year in the future. By using present-worth,
costs and benefits, regardless of when averted in time, are valued equally. Based on OMB
guidance (OMB Circular No. A-4, September 17, 2003), present-worth calculations are
presented using both 3 percent and 7 percent real discount rates. The 3 percent rate
approximates the real rate of return on long-term government debt which serves as a proxy for
the real rate of return on savings. This rate is appropriate when the primary effect of the
regulation is on private consumption. Alternatively, the 7 percent rate approximates the
marginal pretax real rate of return on an average investment in the private sector, and is the
appropriate discount rate whenever the main effect of a regulation is to displace or alter the use
of capital in the private sector. The NRC seeks public comments on the accuracy of these
regulatory analysis assumptions and on the validity of the proposed rule’s value and impact
estimation methods.
3.2.1

Data and Assumptions

The analysis assumes that one-time implementation cost for Industry, the Agreement States
and NRC-proposed changes to §§ 35.13(d) and 35.65(b)(1) would be incurred in calendar year
2015. The analysis assumes that NRC one-time implementation costs associated with rule
development and guidance documents are incurred in years 2012-2015. The analysis assumes
that ongoing costs related to revised and consolidated requirements in 10 CFR Parts 30, 32,
and 35 would begin in 2015 and would be modeled on an annual cost basis. The analysis
calculated cost and savings over a 10-year time horizon with each year’s costs or savings
discounted back at a 7 percent and 3 percent discount rate in accordance with NUREG/
BR-0058, Revision 4. Costs and savings are expressed in 2013 dollars.
Data/Affected Entities
The analysis assumes that the following entities would be affected by this rule:
•
•
•
•
•
•

NRC
NRC licensees
Agreement States
Agreement State licensees
Manufacturers and/or distribution licensees
Authorized users

Draft Regulatory Analysis
•
•
•
•
•

Page 11

Associate Radiation Safety Officers
Radiation Safety Officers
Authorized medical physicists
Authorized nuclear pharmacists
Medical patients

Number and Type of Licensees
Licensees regulated by the NRC (those licensed by the NRC to use radioactive materials
including NRC Master Material Licensees) and the Agreement States (states who have
assumed regulatory authority over the use of certain radioactive materials in their states) are
equally impacted by the proposed rule. Table 1 provides data from NRC's License Tracking
System on the number of NRC licensees, by category, as of November 2012. The number of
Agreement State licensees is estimated at 5.9 times the number of NRC licensees, based on
historical data obtained from NRC databases. This regulatory analysis is based on the
assumption that all the Agreement States will adopt all of the proposed regulatory changes.

Draft Regulatory Analysis

Page 12

Table 1 Number and Type of Licenses
License Title
Medical Institution –
Broad
Medical Institution –
Written Directive
Required
Medical Institution –
Written Directive Not
Required
Medical Private
Practice – Written
Directive Required
Medical Private
Practice – Written
Directive Not Required
Eye Applicators
Strontium-90
Mobile Medicine
Service – Written
Directive Not Required
High Dose-Rate
Remote Afterloader
Mobile Medical Service
– Written Directive
Required
Medical Therapy –
Other Emerging
Technology
Teletherapy
Gamma Stereotactic
Radiosurgery
Sub totals
TOTAL

Program
codes 1

NRC2

Master
Materials
License3

Total
NRC
Licensees

Agreement
States4

Total
Licensees

2110

395

462

2120

257

338

1994

2332

2121

145

158

932

1090

2200

342

400

2201

286

1687

1973

2210

2220

242

283

2230

502

587

2231

2240

153

179

2300

2310

945

138

1083

6389

NRC Material License Program Codes, November 2012.
Data from NRC License Tracking System (LTS), November 2012.
3
Master Material Licenses (such as Navy and Veterans Affairs)
4
Estimated, based on 1 to 5.9 ratio of NRC licensees to Agreement State licensees
2

7472

Draft Regulatory Analysis

Page 13

The NRC estimates that there are two licensees (program code 2511) who are manufacturers or
distributors of medical generators. These Part 30 licensees are only impacted by the proposed
changes to §§ 30.34(g) and 30.50(b)(5). These licensees are not included in the NRC
estimates for medical licensees affected by this proposed rule.
Assumptions
The analysis makes the following other assumptions:
•

The NRC estimates that, on average, all licensees will have added one ARSO on their
licenses.

•

The NRC estimates that, on average, license amendments will take 0.5 hour of
NRC/Agreement State time to review/process. To review the entire NRC Form
313/Application will take 4 hours.

•

The NRC estimates that, on average, licensee application/NRC Form 313 submitted in its
entirety will take 1 hour of physician time and 3 hours of clerical time to prepare and submit.
To complete the proposed required amendments, portions of NRC Form 313 will need to be
completed. The NRC estimates that it takes 0.5 hour to complete each section of the form.

•

The NRC’s labor rates are determined using the methodology in Abstract 5.2, “NRC Labor
Rates,” of NUREG/CR-4627, "Generic Cost Estimates, Abstracts from Generic Studies for
Use in Preparing Regulatory Impact Analyses." This methodology considers only variable
costs (including salary and benefits) that are directly related to the implementation,
operation, and maintenance of the proposed amendments. Currently, the NRC’s hourly
labor rate is $126. The estimation of costs for rulemaking is based on professional NRC
staff full-time equivalent (FTE). Based on actual data from the NRC’s time and labor
system, the number of hours in 1 year that directly relates to implementation of assigned
duties is 1,375 (1,375 was derived by taking the annual number of hours (2,080) and
accounting for leave, training, and completing administrative tasks). Therefore, an NRC
professional staff FTE hourly rate is based on 1,375 hours.

•

Agreement State labor rates were determined from the National Wage Data available on the
Bureau of Labor Statistics Web site (www.bls.gov). Because exact hourly rates would be
difficult to obtain for each of the 37 Agreement States and may not be sufficiently recent,
nationwide mean hourly rates were used. For all Agreement State labor rates, $60.80/hour
is used, which is from the Bureau of Labor Statistics Employer Costs for Employee
Compensation data set, under the category “Lawyers.” The rate was then increased using a
multiplier of 1.5 to account for benefits (pension, insurance premiums, and legally required
benefits) that resulted in an hourly rate of $91.20.

•

Licensee labor rates were obtained from the National Wage Data available on the Bureau of
Labor Statistics Web site (www.bls.gov). Depending on the industry and the occupation
(e.g., manufacturing, health and safety, etc.), an appropriate mean hourly labor rate was
selected. The rate was then increased using a multiplier of 1.5 to account for benefits
(pension, insurance premiums, and legally required benefits). Because exact hourly rates

Draft Regulatory Analysis

Page 14

would be difficult to obtain and may not be sufficiently recent, nationwide mean hourly rates
were used. The bases for the labor rates are as follows. For licensee labor rates, three
labor rates are used. For clerical recordkeeping labor cost, $29.54/hour is used ($19.69 X
1.5), which is from the Compensation data set “Miscellaneous healthcare practitioner and
technical workers. For physician labor cost, $128.51/hour is used ($85.67 X 1.5), which is
from the data set “Physician.” For nuclear technician labor cost, $72.54/hour is used
($48.36 X 1.5), which is from the data set “Nuclear technician.” As described in the Office of
Management and Budget (OMB) Circular A-76, “Performance of Commercial Activities,” the
number of productive hours in one year is 1,776. As this actual value is likely to vary from
state to state and no specific data was available, the FTE costs for the Agreement States
are based on the number of hours estimated in OMB Circular A-76.
•

Licensee turnover rates were obtained from Job Openings and Labor Turnover Survey Data
available on the Bureau of Labor Statistics Web site (www.bls.gov). Based on this data, the
NRC estimates the licensee turnover rate to be 3.0 percent annually. For the purpose of
this analysis, the NRC estimates the total number of licensees to be constant over the
10-year analysis period.

•

The analysis assumes that the final rule will be published in early 2015 and would be
effective in mid-2015.

•

The NRC estimates that 30 percent of the applicants and AMPs, AUs, and RSOs currently
listed on NRC and Agreement State medical licenses are board certified. For ANPs, this
estimate is 10 percent.

•

For the purpose of this analysis, the NRC assumes a 10-year licensing period and a
10 percent renewal annually.

•

The NRC estimates that 10 percent of licensees will submit an amendment annually to
change tasks/duties of ARSOs on their licenses.

•

The analysis calculated cost over a 10-year timeframe with each year’s costs or savings
discounted back at a 7 percent and 3 percent discount rate, in accordance with
NUREG/BR-0058,, “Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory
Commission,” Revision 4.

•

To the extent practical, quantitative information (e.g., costs and savings) and qualitative
information (e.g., the nature and magnitude of impacts) on attributes affected by the rule
were obtained from, or developed in consultation with, the NRC staff.

3.3

Detailed Results

This section presents a detailed estimate of the impacts by attribute for the proposed
rulemaking (Option 2). Some benefits and costs are addressed qualitatively for reasons
discussed in Section 3.2. Exhibit 4-1 summarizes these results.

Draft Regulatory Analysis

Page 15

Option 1: No Action
By definition, this option does not result in any benefits or costs. The baseline for Option 2 is
the No-Action Alternative. The baseline assumes full compliance with existing NRC
requirements. This baseline is consistent with NUREG/BR-0058, which states that, “in
evaluating a new requirement...the staff should assume that all existing NRC requirements have
been implemented.”
Option 2: Amend Regulations to Revise 10 CFR Parts 30, 32, and 35
For details of how the NRC determined the number of licensees and individuals affected by
Option 2, see Appendix B.
Industry Implementation
Amendment for ARSO
Section 35.13(d) would require a licensee to apply for and receive a license amendment prior to
permitting an individual to work as an ARSO or before the RSO assigns different tasks and
duties to an ARSO currently authorized on the license. The NRC estimates that all 7,473
licensees will add an ARSO. Some of the larger medical licensees will have several ARSOs,
while other smaller licensees will have none, but on average there will be one ARSO per
licensee. The NRC determined that allowing ARSOs to be named on a license would increase
the number of individuals who would be available to serve as preceptors for individuals seeking
to be appointed as RSOs or ARSOs. Also, by being named on a license, ARSOs could more
easily become RSOs on other licenses for the types of uses for which they qualify. This will be
a 0.5 labor hour cost per licensee for processing an amendment.
Recordkeeping
Section 35.24(b) would require the written documentation of the RSO-delegated duties to an
ARSO, management’s appointment of an ARSO, and the ARSO acceptance of the duties and
delegated tasks. This paragraph would be modified to allow the licensee’s management to
appoint one or more qualified individuals to serve as ARSOs. The NRC estimates this to be a
1 labor hour cost for all 7,473 impacted licensees.
Adding requirements to current procedures
Section 35.41(b)(5) would require that affected licensees add procedures for any administration
requiring a WD to include procedures for determining if an ME, as defined in § 35.3045, has
occurred. The NRC estimates that 4,126 licensees would add procedures to include this
requirement and the associated cost would be 8 hours physician labor and 1 hour clerical labor.
Section 35.41(b)(6) would require the affected licensee to add procedures for permanent
implant brachytherapy that include a procedure for determining dose/activity parameters within
60 calendar days from the date the implant was performed. If the licensee cannot make these
determinations within the 60 calendar days because of the patient not being available, then the
licensee would have to justify the reason for not making these determinations in writing. The

Draft Regulatory Analysis

Page 16

NRC estimates that 3,373 licensees will add procedures to include this requirement and the
associated cost will be 8 physician labor hours and 1 clerical labor hour.
Licensee cost to meet additional requirements.
Section 35.65(b)(2) would be modified to require licensees that possess bundled or aggregated
single sealed sources with greater than a specified activity to treat them as one single source.
These sources with activities larger than authorized by § 35.65 would have to meet all the
regulatory requirements for that of a single source including, if appropriate, listing on a specific
medical license, leak testing, and security requirements. This requirement is necessary so the
NRC can ensure that adequate controls for security and radiation safety are applied to these
larger sources. The cost for licensees would encompass recordkeeping of new leak test and
security requirements under regulations, if appropriate. In addition, if bundled source activity is
treated as a single source, an amendment to the license would be required. The NRC
estimates the recordkeeping to be 2 labor hours and 0.5 labor hour for the required amendment.
The NRC estimates this to impact 66 licensees.
Recordkeeping
Section 35.2041 would add a one-time recordkeeping cost for the added procedures now
required in § 35.41(b)(5) and (6). The NRC estimates the cost for this recordkeeping
requirement to be 0.10 labor hour for each of the 7,473 impacted licensees.
Table 1 Summary of Industry Implementation Cost
Description

# of Licensees

One-time cost

Notes

35.13(d)

7473

$110,376

Amend license to add ARSO

35.24(b)

7473

$220,752

RSO delegates duties to ARSO, ARSO
accepts and management appoints ARSO

35.41(b)(5)

4126

$4,363,740

Add requirements to existing procedures

35.41(b)(6)

3373

$3,567,352

Add new procedures

35.65(b)(2)

$3,899

Recordkeeping for security and leak test
requirements

35.65(b)(2)

$4,241

Amend license for select bundled single
sources

35.2041

7473

$22,075

Recordkeeping cost for § 35.41(b)(5) and (6)

Total

$8,292,435

Draft Regulatory Analysis

Page 17

NRC Implementation
Processing amendment for ARSO
Section 35.13(d) would require the NRC to process the licensee amendment prior to permitting
an individual to work as an ARSO or before the RSO assigns different tasks and duties to an
ARSO currently authorized on the license.
The NRC estimates that on average all 1,083 NRC licensees will add an ARSO. Some of the
larger medical licensees will have several ARSOs while other smaller licensees will have none,
but on average there will be one ARSO per licensee. This will be a 0.5 labor hour cost to the
NRC per licensee for processing an amendment.
Processing amendment for bundled sources
Section 35.65(b)(2) would require licensees that possess bundled or aggregated single sealed
sources with greater than a specified activity to treat them as one single source. These sources
with activities larger than authorized by § 35.65 would have to meet all the regulatory
requirements for that single source including, if appropriate, listing on a specific medical license,
leak testing, and security requirements. This requirement is necessary so the NRC can ensure
adequate controls for security and radiation safety are applied to these larger sources. If
bundled source activity is treated as a single source an amendment to the license is required.
The NRC estimates 0.5 labor hours to process the required amendments, and this will impact
10 licensees.
Develop rule package and revise guidance documents
The NRC would develop the proposed and final rule packages and revise guidance and
inspection procedures to accommodate the requirements that would be added or modified by
the rulemaking process. This effort will require 1.5 of an FTE (2,062.5 hours) for participating in
the rulemaking activities over a 2-year period. To revise and update the guidance documents
will take 0.5 FTE (687.5 hours). This is an approximately $400,000 one-time cost to the NRC.
The analysis assumes that NRC one-time implementation costs associated with rule
development and guidance documents are incurred in years 2013-2016.
The NUREG guidance documents listed below would be updated:
•

NUREG-1556 Volume 9, Program-Specific Guidance About Medical Use Licenses
(Revision 2).

•

NUREG-1556 Volume 13, Program-Specific Guidance About Commercial
Radiopharmacy Licenses (Revision 1).

•

Inspection Procedure 87132.

Draft Regulatory Analysis

Page 18

Table 2 Summary of NRC Implementation Cost

Section

35.13(d)
35.65(b)(2
)

Description
Process
amendment
Process
amendment
Rule
developme
nt

One
time
cost in
year
2013

One
time
cost in
year
2014

One
time
cost in
year
2015

Undiscounte
d cost

Total 3
Yr 3%
NPV

Total 3
Yr 7%
NPV

$68,229

$630

$86,625

$259,875

$245,02
8

$227,33
1

Guidance
documents

$28,875

$86,625

$81,676

$75,777

Total

$115,50
0

$184,35
9

$415,359

$395,56
3

$371,96
7

Other Governments Implementation (Agreement States)
Amendment for ARSO
Section 35.13(d) would require a licensee to apply for and receive a license amendment prior to
permitting an individual to work as an ARSO or before the RSO assigns different tasks and
duties to an ARSO authorized on the license.
The NRC estimates that on average all 6,390 Agreement State licensees will add an ARSO.
Some of the larger medical licensees will have several ARSOs, while other smaller licensees
will have none, but on average there will be one ARSO per licensee. This will be a 0.5 hour
cost per licensee for processing an amendment.
Processing amendment for bundled sources
Section 35.65(b)(2) would require licensees that possess bundled or aggregated single sealed
sources with greater than a specified activity to treat them as one single source. These sources
with activities larger than authorized by § 35.65 would have to meet all the regulatory
requirements for that single source including, if appropriate, listing on a specific medical license,
leak testing, and security requirements. This requirement is necessary so the NRC can ensure
adequate controls for security and radiation safety are applied to these larger sources. If
bundled source activity is treated as a single source an amendment to the license is required.
The NRC estimates 0.5 labor hour to process the required amendments, and this will impact 56
licensees.

Draft Regulatory Analysis

Page 19

Develop rule package and revise guidance documents
The Agreement State staffs would develop the rule packages to accommodate the requirements
that would be added or modified by the rulemaking process. Revised guidance and inspection
procedures may or may not be required depending on each state’s process. Some Agreement
States adopt the NRC’s guidance and inspection procedures without change. The rulemaking
effort will require 0.5 of an FTE (888 hours) on average for each of the 37 Agreement States.
To revise and update the guidance documents and inspection procedures will take 0.25 FTE
(444 hours). This is an estimated $121,500 one-time cost to each of the 37 Agreement States.
Table 3 Summary of Agreement State Implementation Costs
Section

Description

One-time cost

35.13(d)

Process
amendment
Process
amendment
Update
regulations
Guidance
documents

$582,768

$2,996,467

Total

$5,082,576

35.65(b)(2)
N/A
N/A

$5,107

$1,498,234

Industry Operation
Reporting requirement
Section 30.34(g)would require licensees to report to the NRC/Agreement States the results of
any test of generator elutions for Mo-99 breakthrough or Sr-82 and Sr-85 contamination that
exceeds the permissible concentration listed in § 35.204(a). Issues have occurred with
generators that may cause unwarranted radiation exposure to patients.
It is estimated by the NRC that the rule change would impact two licensees. The NRC
estimates each licensee will report nine instances annually with a 0.5 labor hour cost for each
report.
Reporting requirement
Section 30.50(b)(5) would require manufacturers or distributors of medical generators in receipt
of a notification required by § 35.3204(a) to notify the NRC/Agreement States within 24 hours.
Section 35.3204(a) would require licensees to notify the manufacturer or distributor of the
generator when an eluate from a generator exceeds the permissible concentration listed in
§ 35.204(a).
It is estimated by the NRC that this change would impact two licensees. The NRC estimates
each licensee will report nine instances annually with a 0.5 hour cost for each report.

Draft Regulatory Analysis

Page 20

Savings for the licensees for no longer requiring a copy of application
Section 35.12 (b)(1) would be amended to remove the requirement to submit additional copies
of the NRC Form 313 when applying for a license.
The NRC estimates the licensees averaged 0.25 hour to make and submit additional copies of
their application. The NRC estimates that there will be 224 new applications submitted
annually.
Cost for licensees to submit information on an ARSO
Section 35.12(b)(1) also would add a requirement to submit information on an individual seeking
to be identified as an ARSO.
The NRC estimates that there will be 224 new applications submitted annually requiring
applicants to submit information on an ARSO with a 0.5 hour cost per applicant.
Savings on copies of amendments or renewals of applications
Section 35.12(c)(1) would remove the requirement to submit an additional copy of NRC Form
313 or a letter containing information required by NRC Form 313 for license amendments or
renewals.
The NRC estimates the licensees will save 0.25 hours to copy and submit an additional copy of
NRC Form 313 for renewals. The renewal timeframe is 10 years. The NRC estimates that
there will be on average 747 renewals submitted annually.
For copies of amendments which are submitted on NRC Form 313, the NRC estimates there
will be one amendment per licensee for a total of 7,473 submitted annually.
Licensing amendments for new ARSOs
Section 35.13(d) would require a licensee to apply for and receive a license amendment prior to
permitting an individual to work as an ARSO or before the RSO assigns different tasks and
duties to an ARSO authorized on the license. For the purpose of this analysis, the NRC
assumes a 3 percent licensee turnover rate. This would represent 224 total licensees. In
addition, 10 percent of all ARSOs will have their duties and tasks amended annually. This will
be a 0.5 hour cost per licensee.
Allow licensees to receive certain sealed sources without first seeking a license amendment
Section 35.13(i) would be added to this section to allow licensees to receive certain sealed
sources without first seeking a license amendment. This change is proposed to make it easier
for the licensee to obtain the sealed sources necessary for patient treatments in a timely
manner. The NRC assumes that each affected licensee will receive two new sealed sources
annually. This proposed amendment would allow licensees to save on submittals of two
amendments/NRC Form 313s for a 1.0 labor hour savings annually. The NRC estimates this to
affect 3,498 licensees annually.

Draft Regulatory Analysis

Page 21

Cost to licensee to process notification
Section 35.14(b)(1) would require a licensee to notify the NRC/Agreement States within 30 days
after the ARSO or ophthalmic physicist is removed from the list of individuals that the licensee is
required to report when the ARSO or ophthalmic physicist discontinues performance of duties
under the license or has a name change.
The NRC estimates that 224 new ARSOs will be named annually due to turnover and 38 (0.5
percent of total) due to a name change. The NRC estimates this to be a 0.25 labor hour cost.
The number of new ophthalmic physicists is too low to establish an estimated labor cost.
Costs for licensee to process notification
Section 35.14(b)(6) would require the licensee to notify the NRC if it receives certain sealed
sources without first obtaining a license amendment. Specifically, a licensee would have to
notify the NRC no later than 30 days after receiving a sealed source from a new manufacturer
or a new model number for a sealed source listed in the SSDR used for manual brachytherapy
for quantities and isotopes already authorized by the license. The notification is used in lieu of a
license amendment which is being removed under § 35.13(i). This notification is required for
the NRC to have an accurate record of sealed sources possessed by a licensee.
The NRC estimates that 3.498 licensees will be impacted twice annually, and each notification
will take 0.25 hour to process.
Recordkeeping for new ARSOs
Section 35.24(b) would require written documentation for managing appointments of ARSOs,
ARSOs acceptance of the appointment, and the RSO assignment of tasks and duties. This
paragraph would be modified to allow the licensee’s management to appoint one or more
qualified individuals to serve as ARSOs. The NRC estimates this to be a 1 hour cost for the 224
licensees impacted with turnover.
Adding new procedures
Section 35.41(b)(5) would require licensees to add procedures for any administration requiring a
WD to include procedures for determining if an ME, as defined in § 35.3045, has occurred.
The NRC estimates that 124 licensees, due to turnover, will add procedures to meet this
requirement and the associated cost will be 8 physician labor hours and 1 clerical labor hour.
Adding new procedures
Section 35.41(b)(6) would require a licensee to add procedures for permanent implant
brachytherapy that would include a procedure for determining several dose/activity parameters
within 60 calendar days from the date the implant was performed. If the licensee cannot make
these determinations within the 60 calendar days because of the patient not being available,
then the licensee would have to justify the reason for not making these determinations in writing.

Draft Regulatory Analysis

Page 22

The NRC estimates that 101 licensees, due to turnover, will add procedures to include this
requirement and the associated cost will be 8 physician labor hours and 1 clerical labor hour.
Savings for removing attestation requirement for some individuals
Section 35.14(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State when using the notification process. The
number of ophthalmic physicists is too low to establish an estimated labor savings.
Section 35.50(a) would remove the requirement for individuals seeking to be named as an RSO
or ARSO (including medical physicists identified in section 35.50(c)(1)) to obtain a written
attestation for those individuals who are certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State. The NRC estimates that
approximately 224 individuals will seek to become RSOs and ARSOs under Section 35.50
annually. Of these, the NRC estimates that 30 percent, or 67, are individuals who are certified
by a specialty board whose certification process has been recognized by the NRC or an
Agreement State. The NRC estimates a savings of 0.5 labor hour per licensee for no longer
requiring the submittal of an amendment.
Licensee savings for processing only one application
Section 35.50(c)(3) would allow an individual who is qualified to be the AU, but is not named on
a medical license or permit, to be named simultaneously as both the AU and RSO for the same
uses on a new medical license. This new provision saves the applicant from submitting an
amendment to the initial AU application to be named as an RSO. The NRC estimates this to
affect three applicants annually at a savings of 0.5 hour per application.
Savings for removing the attestation requirement for some individuals
Section 35.51(a) would remove the requirement for individuals seeking to be named as an AMP
to obtain a written attestation for those individuals who are certified by a specialty board whose
certification process has been recognized by the NRC or an Agreement State. The NRC
estimates that approximately 37 individuals annually will seek to become AMPs under § 35.51
with a savings of 0.5 labor hour per licensee for no longer requiring the submittal of an
amendment.
Section 35.55(a) would remove the requirement for individuals seeking to be named as an ANP
to obtain a written attestation for those individuals who are certified by a specialty board whose
certification process has been recognized by the NRC or an Agreement State. The NRC
estimates this to impact seven licensees annually with a savings of 0.5 labor hour per licensee
for no longer requiring the submittal of an amendment.
Savings for removing training requirements for certain AMPS and ANPs
Section 35.57(a)(1) would remove the requirement for AMPs and ANPs who are identified on a
Commission or an Agreement State license or a permit issued by a Commission or an
Agreement State broad scope licensee or master material license permit or by a master material

Draft Regulatory Analysis

Page 23

license permittee of broad scope on or before October 24, 2005, to comply with the training
requirements of §§ 35.50, 35.51, or 35.55, respectively. The NRC estimates that 41 licensees
will be impacted annually, and there will be a savings of 0.5 hour associated with the submittal
of an amendment on NRC Form 313.
Savings for removing training requirement for certain RSOs
Section 35.57(a)(2) would recognize individuals certified by the named boards in the now
removed Subpart J of Part 35 on or before October 24, 2005, who would not need to comply
with the training requirements of § 35.50 to be identified as a RSO on a Commission or an
Agreement State license or Commission master material license permit for those materials and
uses that these individuals performed on or before October 24, 2005. The NRC estimates that
75 licensees will be impacted annually, and there will be a savings of 0.5 hour associated with
the submittal of an amendment on NRC Form 313.
Savings for removing training requirements for certain individuals
Section 35.57(a)(3) would be modified to remove the requirement for individuals certified by the
named boards in the now removed Subpart J of Part 35 on or before October 24, 2005, to
comply with the training requirements of § 35.51 to be identified as a AMP on a Commission or
an Agreement State license or Commission master material license permit for those materials
and uses that these individuals performed on or before October 24, 2005. The NRC estimates
that 41 licensees will be impacted annually, and there will be a savings of 0.5 hour associated
with the submittal of an amendment on NRC Form 313.
Savings for removing T&E requirements for certain individuals
Section 35.57(b)(1) would be amended to clarify that individuals authorized before, rather than
just on, October 24, 2005, would not be required to comply with the T&E requirements in
Subparts D through H of 10 CFR Part 35 for those materials and uses that they performed on or
before that date. The NRC estimates that 2,242 or 30 percent of all licensees, will be impacted
on an annual basis. The 0.5 labor hour savings will be associated with each submittal of
amendment on NRC Form 313.
Section 35.57(b)(2) would be restructured and expanded to recognize physicians, dentists, or
podiatrists who were certified by the named boards in the now removed Subpart J of Part 35 on
or before October 24, 2005, who would not need to comply with the T&E requirements of
Subparts D through H of 10 CFR Part 35 to be identified as an AU on a Commission or an
Agreement State license or Commission master material license permit for those materials and
uses that these individuals performed on or before October 24, 2005. The NRC estimates that
187, or 2.5 percent of all licensees, will be impacted on an annual basis. The 0.5 labor hour
savings will be associated with each submittal of amendment on NRC Form 313.
Cost to possess certain bundled sources
Section 35.65(b)(2) would be modified to require licensees that possess bundled or aggregated
single sealed sources with greater than a specified activity to treat them as one single source.
These sources with activities larger than authorized by § 35.65 will have to meet all the

Draft Regulatory Analysis

Page 24

regulatory requirements for that single source including, if appropriate, listing on a specific
medical license, leak testing, and security requirements. This requirement is necessary so the
NRC can ensure that adequate controls for security and radiation safety are applied to these
larger sources. The cost for licensees will encompass recordkeeping of new leak tests and
security requirements under regulations, if appropriate. In addition, if bundled source activity is
treated as a single source, an amendment to the license is required. The NRC estimates this to
impact 10 licensees annually, for 2 hours of recordkeeping cost and 0.5 hour for submitting an
amendment.
Savings for removing attestation requirement for some individuals
Section 35.190(a) would remove the written attestation requirement for a physician who is
certified by a specialty board whose certification process has been recognized by the NRC or an
Agreement State and is seeking to be named as an AU for byproduct material authorized under
§ 35.100. The NRC estimates that this will impact 59 licensees on an annual basis with a
savings of 0.5 labor hour for no longer requiring the submittal of a written attestation with the
amendment request.
Recordkeeping cost
Section 35.204(b) would be modified to require licensees to measure the Mo-99 concentration
after each eluate from a Mo-99/Tc-99m generator. Generator manufacturers recommended
testing each elution prior to use in humans. Mo-99 breakthrough measurements which exceed
the permissible concentration listed in § 35.204(a) may cause unnecessary radiation exposure
to patients. The NRC assumes that each test will be conducted by a nuclear technician who is
under the supervision of an ANP. The NRC estimates this to impact 419 licensees (2,795
affected licensees of which 15 percent will have an ANP) who have the generators. The new
requirements will require the affected licensees to keep records of their test measurements.
The NRC estimates this to require 25 Medical Technician labor hours annually for each affected
licensee.
Reporting requirement
Section 35.204(e) would require licensees to report any measurement that exceeded the limits
specified in § 35.204(a) for Mo-99/Tc-99m and Sr-82/Rb-82 generators. Generator
manufacturers recommended testing each elution prior to use in humans. Mo-99 breakthrough
measurements which exceed the permissible concentration listed in § 35.204(a) may cause
unnecessary radiation exposure to patients. The NRC estimates the affected licensees to
report seven occurrences on average annually. The reporting requirement includes an initial
phone notification within 1 calendar day from occurrence, followed up with a written report due
in 15 days. The NRC estimates this to be a 2.25 physician labor hour cost (0.25 hour for the
phone call and 2 hours for the written report).
Savings for removing the attestation requirement for some individuals
Section 35.290(a) would remove the requirement for physicians seeking to be named as an AU
of unsealed byproduct material for uses authorized under § 35.200 to obtain a written attestation
for those individuals who are certified by a specialty board whose certification process has been

Draft Regulatory Analysis

Page 25

recognized by the NRC or an Agreement State. The NRC estimates that this will impact 59
licensees on an annual basis with a savings of 0.5 physician labor hour per licensee for no
longer requiring the submittal of a written attestation with the amendment request.
Savings for removing the attestation requirement for some individuals
Section 35.390(a) would remove the requirement for physicians seeking to be named as an AU
of unsealed byproduct material which requires a written directive for uses authorized under
§ 35.300 to obtain a written attestation for those individuals who are certified by a specialty
board whose certification process has been recognized by the NRC or an Agreement State.
The NRC estimates that this will impact 29 licensees on an annual basis with a savings of 0.5
physician labor hour per licensee for no longer requiring the submittal of a written attestation
with the amendment request.
Savings for removing the attestation requirement for some individuals
Section 35.392(a) would remove the requirement for physicians seeking to be named as an AU
for the oral administration of sodium iodide I-131 requiring a written directive in quantities less
than or equal to 1.22 gigabecquerels (33 millicuries) to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State. The NRC estimates that this will impact 29
licensees on an annual basis with a savings of 0.5 physician labor hour per licensee for no
longer requiring the submittal of a written attestation with the amendment request.
Savings for removing attestation requirement for some individuals
Section 35.394(a) would remove the requirement for physicians seeking to be named as an AU
for the oral administration of sodium iodide I-131 requiring a written directive in quantities
greater than 1.22 Gigabecquerels (33 millicuries) to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State. The NRC estimates that this will impact 29
licensees on an annual basis with a savings of 0.5 physician labor hour per licensee for no
longer requiring the submittal of a written attestation with the amendment request.
Flexibility for AMP turnover
Section 35.433 would be amended and expanded to allow certain individuals who are not AMPs
to calculate the activity of strontium-90 sources that is used to determine the treatment times for
ophthalmic treatments. These individuals who are not AMPs would have to meet the T&E
requirements detailed in the new paragraph (a)(2) of this section to perform the specified
activities. These requirements are similar to the T&E requirements for an AMP, but include only
the requirements related to brachytherapy programs. The NRC determined that this will
increase the number of qualified individuals available to support the use of ophthalmic
treatments. This will expand the pool of qualified individuals and provide the licensees greater
flexibility with no associated cost.

Draft Regulatory Analysis

Page 26

Savings for removing attestation requirement for some individuals
Section 35.490(a) would remove the requirement for physicians seeking to be named as an AU
of a manual brachytherapy source for the uses authorized under § 35.400 to obtain a written
attestation for those individuals who are certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State. The NRC estimates that this
will impact 31 licensees on an annual basis with a savings of 0.5 physician labor hour per
licensee for no longer requiring the submittal of a written attestation with the amendment
request.
Cost for training
Section 35.610(d)(1) would be restructured to add a new training requirement for use of remote
afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. This proposed
amendment would require all individuals who would operate these units to receive vendor
operational and safety training prior to the first use for patient treatment of a new unit or an
existing unit with a manufacturer upgrade that affects the operation and safety of the unit. The
NRC assumes this will impact 172 licensees on an annual basis who will add a new unit or
modify an existing unit. The NRC assumes this training to take 1 physician labor hour.
Change to inspections and servicing intervals
Section 35.655(a) would be amended to change the requirement for intervals for full inspection
and servicing for gamma stereotactic radiosurgery units from 5 years to 7 years. The cost to
replace the sources in a gamma stereotactic radiosurgery unit can be exorbitant. Licensees
have routinely requested, and the NRC has granted, extensions for the full inspection service for
these units beyond 5 years. The NRC does not anticipate any savings or cost to the licensees
for this change.
Savings for removing attestation requirement for some individuals
Section 35.690(a) would remove the requirement for physicians seeking to be named as an AU
for sealed sources for uses authorized under § 35.600 to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State. The NRC estimates this to impact 10 licensees
annually with a savings of 0.5 physician labor hour per licensee for no longer requiring the
submittal of a written attestation with the amendment request.
Recordkeeping
Section 35.2024(c)(1) and (2) would require licensees to keep records of each ARSO assigned
under § 35.24(b) for 5 years after the ARSO is removed from the license. These records would
have to include the written document appointing the ARSO signed by the licensee’s
management and each agreement signed by the ARSO listing the duties and tasks assigned by
the RSO under § 35.24(b). The NRC estimates that due to turnover, 224 ARSOs will be
removed from licenses annually with a cost of 1 clerical labor hour.

Draft Regulatory Analysis

Page 27

Savings on phone notifications of MEs
Section 35.3045(c) would reduce telephone reporting costs to the NRC because the
requirements for reporting an ME for permanent implant brachytherapy are changed in
§ 35.3045(a)(2). The new requirements will not capture events that are not of significance and
will reduce the number of reportable MEs related to permanent implant brachytherapy. The
NRC estimates 7 licensees will be impacted annually with a saving of 0.5 medical technician
labor hour on each notification.
Savings on written follow-up reports on MEs
Section 35.3045(d) would reduce written reporting costs to the NRC because the requirements
for reporting an ME for permanent implant brachytherapy are changed in § 35.3045(a)(2). The
new requirements will not capture events that are not of significance and will reduce the number
of reportable MEs related to permanent implant brachytherapy. The NRC estimates 7 licensees
will be impacted annually with a savings of 2 physician labor hours and 6 clerical labor hours on
each report.
Savings for the licensee on reporting MEs
Section 35.3045(e) would reduce licensee reporting costs to the physician, because the
requirements for reporting an ME for permanent implant brachytherapy are changed in
§ 35.3045(a)(2). The new requirements will not capture events that are not of significance and
will reduce the number of reportable MEs related to permanent implant brachytherapy. The
NRC estimates 7 licensees will be impacted annually with a total savings of 5 physician labor
hours for each licensee.
Increased flexibility for AUs for use of sealed sources and devices for manual brachytherapy
Sections 35.400, 35.500, and 35.600 would be amended to allow AUs to use sealed sources
and devices listed in SSDRs for manual brachytherapy for other medical uses that are not
explicitly listed in the SSDR provided that these sources are used in accordance with the
radiation safety conditions and limitations described in the SSDR. This increased flexibility is
not quantifiable.

Draft Regulatory Analysis

Page 28

Table 4 Summary of Industry Annual Costs
Citation

Description

30.34(g)
30.50(b)(5)
35.12(b)(1)
35.12(b)(1)
35.12 (c )(1)
35.12 (c )(1)
35.13(d)

Reporting requirement
Reporting requirement
Savings for no longer requiring copy of application
Cost for licensees to submit information on ARSO
Savings on copy of renewals
Savings on copy of amendments
Licensing amendments for new ARSOs
Licensing amendments for new tasks/duties for existing
ARSO
Savings exemption for need for amendment for sealed
source
Cost for notification for when ARSO or ophthalmic
physicist leaves or changes name
Notification costs for reporting
Recordkeeping for new ARSOs
Adding new procedures
Adding new procedures
Savings for some RSO for attestation
Savings for processing only one application
Savings for removing attestations for some individuals
Savings for removing attestations for some individuals
Savings for individuals who want to be ANPs and AMPs
Savings for individuals certain RSOs
Savings for individuals who want to be identified as
AMPs
Savings for AU on T&E from 10/24/02 to 10/24/05
Savings for individuals who want to be AUs
Recordkeeping requirements for leak tests and security
Cost requiring a licensee to submit an amendment
Savings for removing attestations for some individuals
Cost to check generators for each elution
Reporting requirement (cost in § 35.3204)
Savings for removing attestations for some individuals
Savings for removing attestations for some individuals
Savings for removing attestations for some individuals
Savings for removing attestations for some individuals
No additional cost
Savings for removing attestations for some individuals
Cost for training for operations and safety
Savings for removing attestations for some individuals
Recordkeeping cost (Removing ARSO)

35.13(d)
35.13(i)
35.14(b)(1)
35.14(b)(6)
35.24(b)
35.41(b)(5)
35.41(b)(6)
35.50(a)
35.50(c)(3)
35.51(a)
35.55(a)
35.57(a)(1)
35.57(a)(2)
35.57(a)(3)
35.57(b)(1)
35.57(b)(2)
35.65(b)(2)
35.65(b)(2)
35.190(a)
35.204(b)
35.204(e)
35.290(a)
35.390(a)
35.392(a)
35.394(a)
35.433(a)(2)
35.490(a)
35.610(d)(1)
35.690(a)
35.2024( c)

No. of
Licensees
Affected
2
2
224
224
747
7473
224

$266
$266
-$1,654
$3,308
-$5,517
-$55,188
$3,308

747

$11,033

3498

-$51,665

262

$1,935

3498
224
124
101
67
3
37
7
41
75

$25,833
$6,617
$131,145
$106,820
-$4,305
-$193
-$2,377
-$450
-$2,634
-$4,819

-$2,634

2242
187
10
10
59
419
7
59
29
29
29
0
31
172
10
224

-$144,060
-$12,016
$591
$148
-$3,791
$760,066
$2,024
-$3,791
-$1,863
-$1,863
-$1,863
$0
-$1,992
$22,104
-$643
$2,203

Annual
Costs

Draft Regulatory Analysis
35.2024(c)(1) Recordkeeping cost (ARSO appointment)
35.2024(c)(2) Recordkeeping cost (ARSO signed agreement)
35.3045(c) Phone notifications reduced
35.3045(d) Written reports reduced
35.3045(e) Physician notifications reduced
Total

Page 29
224
224
7
7
7

$2,203
$2,203
-$254
-$3,040
-$1,799
$773,661

NRC Operation
Processing reports
Section 30.34(g) would require the NRC to process licensee reports of any test that exceeds the
permissible concentration listed in § 35.204(a). The NRC estimates it will receive one report
annually, and 1 labor hour would be needed to process it.
Processing reports
Section 30.50(b)(5) would require the NRC to process reports from manufacturers or distributors
of medical generators in receipt of a notification required by § 35.3204(a). The NRC estimates it
will receive one report annually, and 1 labor hour would be needed to process it.
Processing licensee application due to turnover of ARSOs
Section 35.12(b)(1) would require an applicant to include T&E qualifications for each ARSO as
part of its license application. The NRC estimates it will receive 29 new applications annually,
and that it will take 0.25 hour to process each application.
Amendment processing due to turnover of ARSOs
Section 35.13(d) would require a licensee to apply for and receive a license amendment prior to
permitting an individual to work as an ARSO or before the RSO assigns different tasks and
duties to an ARSO currently authorized on the license. The NRC estimates it will receive
29 amendments annually and each amendment will take 0.5 hour to process.
Savings for processing amendments for sealed sources
Section 35.13(i) would allow licensees who are authorized for brachytherapy sources to receive
certain sealed sources without first seeking a license amendment. This change is proposed to
make it easier for the licensee to obtain the sealed sources necessary for patient treatments in a
timely manner. The NRC will no longer need to review and process the license amendments,
and estimates it will receive 1,014 fewer amendments annually with each amendment saving
0.5 hour to process.
Processing of notifications of ARSOs
Section 35.14(b)(1) would require a licensee to notify the Commission within 30 days of removal
of the ARSO or ophthalmic physicist from the list of individuals that the licensee is required to

Draft Regulatory Analysis

Page 30

report when the ARSO discontinues performance of duties under the license or has a name
change.
The NRC estimates that 38 notifications will be made annually due to turnover or name
changes, and it will take 0.25 hour to process each notification. The number of ophthalmic
physicist is too low to establish an estimated labor cost.
Processing of notifications of sealed sources
Section 35.14(b)(6) would require licensees to notify the NRC if it receives certain sealed
sources without first obtaining a license amendment. Specifically, a licensee would have to
notify the NRC no later than 30 days after receiving a sealed source from a new manufacturer
or a new model number for a sealed source listed in the SSDR used for manual brachytherapy
for quantities and isotopes already authorized by the license. The notification is used in lieu of a
license amendment, which is being removed under § 35.13(i). The NRC estimates this to
impact 507 licensees each year, and each licensee will submit two notifications on average per
year with an associated processing cost of 5 minutes. This cost is offset by the savings from
not requiring an amendment in § 35.13(i).
Savings for processing attestations
Section 35.14(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State when using the notification process. The
number of ophthalmic physicists is too low to establish an estimated labor savings.
Section 35.50(a) would remove the requirement for individuals seeking to be named as an RSO
or ARSO to obtain a written attestation for those individuals who are certified by a specialty
board whose certification process has been recognized by the NRC or an Agreement State.
The NRC estimates that approximately 32 individuals will seek to become RSOs under § 35.50
annually. Of these, the NRC estimates that 30 percent, or 10, are individuals who are certified
by a specialty board whose certification process has been recognized by the NRC or an
Agreement State. The NRC estimates that approximately 0.5 hour of the cost associated with
processing the amendment will be saved for each applicant.
Savings for processing and reviewing applications
Section 35.50(c)(3) would allow an individual who is qualified to be the AU, but is not named on
a medical license or permit, to be named simultaneously as both the AU and RSO for the same
uses on a new medical license. This new provision saves the NRC from processing the license
amendment for adding an RSO. The NRC estimates this to affect one applicant annually at a
savings of 0.5 hour for processing the amendment.
Savings for processing attestations
Section 35.51(a) would remove the requirement to obtain a written attestation, for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State, for individuals seeking to be named as an AMP.

Draft Regulatory Analysis

Page 31

The NRC estimates that approximately five individuals will seek to become AMPs under § 35.51
annually. NRC estimates that approximately 0.5 hour cost associated with reviewing the
amendment will be saved for each applicant.
Section 35.55(a) would remove the requirement to obtain a written attestation, for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State, for individuals seeking to be named as an ANP.
The NRC estimates this to impact one licensee annually with 0.5 hour of the cost associated
with processing a written attestation with the amendment request.
Savings for processing amendments
Section 35.57(a)(1) would remove the requirement for an RSO, an AMP and an ANP identified
on a NRC license or a permit issued by the NRC broad scope licensee or master material
license permit or by a master material license permittee of broad scope on or before October
24, 2005, to comply with the training requirements of §§ 35.50, 35.51, or 35.55, respectively.
The NRC estimates that six licensees will be impacted with a savings of 0.5 hour associated
with the processing of each amendment.
Section 35.57(a)(2) would recognize individuals certified by the named boards in the now
removed Subpart J of Part 35 on or before October 24, 2005, who would not need to comply
with the training requirements of § 35.50 to be identified as an RSO on a Commission or an
Agreement State license or Commission master material license permit for those materials and
uses that these individuals performed on or before October 24, 2005. The NRC estimates that
11 licensees will be impacted with a savings of 0.5 hour associated with the processing of each
amendment.
Section 35.57(a)(3) would be modified to remove the requirement for individuals certified by the
named boards in the now removed Subpart J of Part 35 on or before October 24, 2005, to
comply with the training requirements of § 35.51 to be identified as a AMP on a Commission or
an Agreement State license or Commission master material license permit for those materials
and uses that these individuals performed on or before October 24, 2005. The NRC estimates
that six licensees will be impacted with a savings of 0.5 hour associated with the processing of
each amendment.
Section 35.57(b)(1) would be amended to clarify that individuals authorized before, rather than
just on, October 24, 2005, would not be required to comply with the T&E requirements in
Subparts D through H of 10 CFR Part 35 for those materials and uses that they performed on or
before that date. The NRC estimates that 325 licensees will be impacted on an annual basis
with a savings of 0.5 hour associated with the processing of each amendment.
Section 35.57(b)(2) would be restructured and expanded to recognize physicians, dentists, or
podiatrists who were certified by the named boards in the now removed subpart J of part 35 on
or before October 24, 2005, who would not need to comply with the training requirements of
subparts D through H of 10 CFR part 35 to be identified as an AU on an NRC license or an NRC
master material license permit for those materials and uses that these individuals performed on
or before October 24, 2005. The NRC estimates that 27 licensees will be impacted on an
annual basis with a savings of 0.5 hour associated with the processing of each amendment.

Draft Regulatory Analysis

Page 32

Processing amendments for bundled sources
Section 35.65(b)(2) would be modified to require licensees that possess bundled or aggregated
single sealed sources with greater than a specified activity to treat them as one single source.
These sources with activities larger than authorized by § 35.65 will have to meet all the
regulatory requirements for that single source including, if appropriate, listing on a specific
medical license, leak testing, and security requirements. This requirement is necessary so the
NRC can ensure that adequate controls for security and radiation safety are applied to these
larger sources. The NRC estimates this to impact one licensee annually with the amendment
requiring 0.5 hour to process.
Savings for processing attestations
Section 35.190(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC and for physicians seeking to be named as an AU of unsealed
byproduct material for uses authorized under § 35.100. The NRC estimates that this will impact
eight NRC licensees on an annual basis with a savings of 0.5 labor hour for no longer requiring
the submittal of a written attestation with the amendment request.
Cost to process new reporting requirement
Section 35.204(e) would require licensees to report any measurement that exceeded the limits
specified in § 35.204(a) for Mo-99/Tc-99m and Sr-82/Rb-82 generators. Generator
manufacturers recommended testing each elution prior to use in humans. Mo-99 breakthrough
measurements which exceed the permissible concentration listed in § 35.204(a) may cause
unnecessary radiation exposure to patients. The NRC estimates that this will impact one
licensee to report one occurrence on average annually. The reporting requirement includes an
initial phone notification to NRC within 1 calendar day from occurrence and followed up with a
written report due in 15 days. The NRC estimates this to be a 2.25 labor hour cost (0.25 hour to
process the phone call and 2 hours to review the written report).
Savings for processing attestations
Section 35.290(a) would remove the requirement for physicians seeking to be named as an AU
of unsealed byproduct material for uses authorized under § 35.200 to obtain a written attestation
for those individuals who are certified by a specialty board whose certification process has been
recognized by the NRC. The NRC estimates that this will impact 8 licensees on an annual basis
with a savings of 0.5 labor hour for no longer requiring the submittal of an amendment.
Savings for removing attestation requirement for some individuals
Section 35.390(a) would remove the requirement for physicians seeking to be named as an AU
of unsealed byproduct material which requires a written directive for uses authorized under
§ 35.300 to obtain a written attestation for those individuals who are certified by a specialty
board whose certification process has been recognized by the NRC or an Agreement State.
The NRC estimates that this will impact 4 licensees on an annual basis with a savings of 0.5
labor hour per licensee for no longer requiring the submittal of an amendment.

Draft Regulatory Analysis

Page 33

Savings for processing attestations
Section 35.392(a) would remove the requirement to obtain a written attestation, for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC, for physicians seeking to be named as an AU for the oral administration
of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22
gigabecquerels (33 millicuries). The NRC estimates that this will impact four licensees on an
annual basis with a savings of 0.5 labor hour for no longer requiring the submittal of a written
attestation with the amendment request.
Savings for processing attestation
Section 35.394(a) would remove the requirement to obtain a written attestation, for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC, for physicians seeking to be named as an AU for the oral administration
of sodium iodide I-131 requiring a written directive in quantities greater than 1.22
gigabecquerels (33 millicuries). The NRC estimates that this will impact four licensees on an
annual basis with a savings of 0.5 labor hour for no longer requiring the submittal of an
amendment.
Savings for processing attestation
Section 35.490(a) would remove the requirement to obtain a written attestation, for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC, for physicians seeking to be named as an AU of a manual
brachytherapy source for the uses authorized under § 35.400. The NRC estimates that this will
impact five licensees on an annual basis with a savings of 0.5 labor hour for no longer requiring
the submittal of an amendment.
Savings for processing attestations
Section 35.690(a) would remove the requirement to obtain a written attestation, for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC, for physicians seeking to be named as an AU for sealed sources for
uses authorized under § 35.600. The NRC estimates this to impact two licensees annually with
a savings of 0.5 labor hour for no longer requiring the submittal of a written attestation with the
amendment request.
Savings on phone notifications
Section 35.3045(c) would reduce telephone reporting cost to the NRC because the
requirements for reporting an ME for permanent implant brachytherapy are changed in
§ 35.3045(a)(2). The new requirements will not capture events that are not of significance and
will reduce the number of reportable MEs related to permanent implant brachytherapy. The
NRC estimates this to impact one licensee annually with a savings of 2.5 NRC labor hours to
process the ME notification.

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Savings on written follow-up report to the NRC
Section 35.3045(d) would reduce written reporting costs to the NRC because the requirements
for reporting an ME for permanent implant brachytherapy would be changed in § 35.3045(a)(2).
The new requirements will not capture events that are not of significance and will reduce the
number of reportable MEs related to permanent implant brachytherapy. The NRC estimates
this to impact one licensee annually with a savings of 3 NRC labor hours to process the written
report.
Other Governments’ Operation (Agreement States)
The Agreement States are required to adopt the NRC regulations within 3 years after they go
into effect. Although each state has its own regulations with unique sections and numbering
systems, for the purpose of this regulatory analysis, the NRC section and numbering system is
used.
Processing reports
Section 30.34(g) would require the Agreement States to process licensee reports of any test
that exceeds the permissible concentration listed in § 35.204(a). The NRC estimates the
Agreement States will receive one report annually and 1 labor hour would be needed to process
it.
Section 30.50(b)(5) would require the Agreement States to process reports from manufacturers
or distributors of medical generators in receipt of a notification required by § 35.3204(a). The
NRC estimates the Agreement States will receive one report annually and 1 labor hour would be
needed to process it.
Licensee application request processing
Section 35.12(b)(1) would require a licensee to apply for and receive a license amendment prior
to permitting an individual to work as an ARSO or before the RSO assigns different tasks and
duties to an ARSO currently authorized on the license. The NRC estimates the Agreement
States will receive 195 amendment requests annually and that each will take 0.25 hours to
process.
Licensee amendment processing
Section 35.13(d) would require a licensee to apply for and receive a license amendment prior to
permitting an individual to work as an ARSO or before the RSO assigns different tasks and
duties to an ARSO currently authorized on the license. The NRC estimates the Agreement
States will receive 195 amendments annually and each amendment will take 0.5 hour to
process.
Savings for processing amendments for sealed sources
Section 35.13(i) would allow licensees to receive certain sealed sources without first seeking a
license amendment. This change is proposed to make it easier for the licensee to obtain the

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sealed sources necessary for patient treatments in a timely manner. The Agreement States will
no longer need to review and process the license amendments. The NRC estimates that the
Agreement States will receive 5,982 fewer amendments annually, with each amendment saving
0.5 hour to process.
Processing of notifications
Section 35.14(b)(1) would require a licensee to notify the Agreement States within 30 days of
when the ARSO or the ophthalmic physicist is removed from the list of individuals that the
licensee is required to report or when the ARSO or the ophthalmic physicist discontinues
performance of duties under the license or has a name change.
The NRC estimates that 224 ARSOs will be named annually due to turnover or changing their
names, and it will take 0.25 labor hour for the Agreement States to process each notification.
The number of ophthalmic physicist is too low to establish an estimated labor cost.
Section 35.14(b)(6) would require licensees to notify the Agreement States if they receive
certain sealed sources without first obtaining a license amendment. Specifically, a licensee
would have to notify the Agreement State no later than 30 days after receiving a sealed source
from a new manufacturer or a new model number for a sealed source listed in the SSDR used
for manual brachytherapy for quantities and isotopes already authorized by the license. The
notification is used in lieu of a license amendment which would be removed under § 35.13(i).
This notification is required for the Agreement States to have an accurate record of sealed
sources possessed by a licensee.
The NRC estimates this to impact 2,991 licensees each year; each licensee will submit two
notifications on average per year. The NRC estimates that the associated Agreement State
cost to process each notification is 0.08 labor hours. This cost would be offset by the savings
outlined § 35.13(i).
Savings for processing attestations
Section 35.14(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State when using the notification process. The
number of ophthalmic physicists is too low to establish an estimated labor savings.
Section 35.50(a) would remove the requirement for individuals seeking to be named as an RSO
or ARSO to obtain a written attestation for those individuals who are certified by a specialty
board whose certification process has been recognized by an Agreement State. The NRC
estimates that approximately 192 individuals will seek to become RSOs under § 35.50 annually.
Of these, the NRC estimates that 30 percent, or 57, are individuals who are certified by a
specialty board whose certification process has been recognized by the NRC or an Agreement
State. The NRC estimates that approximately 0.5 labor hour of the cost associated with
processing each amendment will be saved by the Agreement States for each applicant.

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Savings for processing and reviewing applications
Section 35.50(c)(3) would allow an individual who is qualified to be the AU, but is not named on
a medical license or permit, to be named simultaneously as both the AU and RSO for the same
uses on a new medical license. This new provision saves the Agreement States from
processing the license amendment. The NRC estimates this to affect two applicants annually at
a savings of 0.5 labor hour per application.
Savings for processing the attestations
Section 35.51(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State, for individuals seeking to be named as an AMP.
The NRC estimates that approximately 32 individuals will seek to become AMPs annually and
that 0.5 hour associated with reviewing the amendment will be saved for each applicant.
Savings for processing attestations
Section 35.55(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State, for individuals seeking to be named as an ANP.
The NRC estimates this to impact six licensees annually, and 0.5 hour of the labor cost
associated with processing a written attestation with the amendment request amendment would
be saved.
Section 35.57(a)(1) would remove the requirement for an RSO, an AMP, and an ANP identified
on an Agreement State license or a permit issued by an Agreement State broad scope licensee
or master material license permit or by a master material license permittee of broad scope on or
before October 24, 2005, to comply with the training requirements of §§ 35.50, 35.51, or 35.55,
respectively. The NRC estimates that 35 licensees will be impacted with a savings of 0.5 hour
associated with the processing of a written attestation with the amendment request.
Savings for processing amendments
Section 35.57(a)(2) would recognize individuals certified by the named boards in the now
removed Subpart J of Part 35 on or before October 24, 2005, who would not need to comply
with the training requirements of § 35.50 to be identified as a RSO on a Commission or an
Agreement State license or Commission master material license permit for those materials and
uses that these individuals performed on or before October 24, 2005. The NRC estimates that
64 licensees will be impacted with a savings of 0.5 hour associated with the processing of each
amendment.
Section 35.57(a)(3) would be modified to remove the requirement for individuals certified by the
named boards in the now removed Subpart J of Part 35 on or before October 24, 2005, to
comply with the training requirements of § 35.51 to be identified as a AMP on a Commission or
an Agreement State license or Commission master material license permit for those materials
and uses that these individuals performed on or before October 24, 2005. The NRC estimates
that 35 licensees will be impacted with a savings of 0.5 hour associated with the processing of
each amendment.

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Section 35.57(b)(1) would be amended to clarify that individuals authorized before, rather than
just on, October 24, 2005, would not be required to comply with the T&E requirements in
Subparts D through H of 10 CFR Part 35 for those materials and uses that they performed on or
before that date. The NRC estimates that 1,917 licensees will be impacted on an annual basis
with a savings of 0.5 hour associated with the processing of each amendment.
Section 35.57(b)(2) would be restructured and expanded to recognize physicians, dentists, or
podiatrists who were certified by the named boards in the now removed Subpart J of Part 35 on
or before October 24, 2005, who would not need to comply with the training requirements of
Subparts D through H of 10 CFR Part 35 to be identified as an AU on an NRC license or an
NRC master material license permit for those materials and uses that these individuals
performed on or before October 24, 2005. The NRC estimates that 160 licensees will be
impacted on an annual basis with a savings of 0.5 hour associated with the processing of each
amendment.
Cost for processing amendments
Section 35.65(b)(2) would be modified to require licensees that possess bundled or aggregated
single sealed sources with greater than a specified activity to treat them as one single source.
These sources with activities larger than authorized by § 35.65 would have to meet all the
regulatory requirements for that single source including, if appropriate, listing on a specific
medical license, leak testing, and security requirements. This requirement is necessary so the
Agreement States can ensure that adequate controls for security and radiation safety are
applied to these larger sources. The NRC estimates this to impact nine licensees annually with
the amendment requiring 0.5 hour to process.
Savings for processing attestations
Section 35.190(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State, for physicians seeking to be named as an AU of
unsealed byproduct material for uses authorized under § 35.100. The NRC estimates that this
will impact 51 Agreement State licensees on an annual basis with a savings of 0.5 labor hour for
no longer requiring the submittal of a written attestation with the amendment request.
Cost for processing new reporting requirement
Section 35.204(e) would require licensees to report any measurement that exceeded the limits
specified in § 35.204(a) for Mo-99/Tc-99m and Sr-82/Rb-82 generators. Generator
manufacturers recommended testing each elution prior to use in humans. Mo-99 breakthrough
measurements which exceed the permissible concentration listed in § 35.204(a) may cause
unnecessary radiation exposure to patients. The NRC estimates the affected licensees to
report six occurrences on average annually. The reporting requirement includes an initial phone
notification to the Agreement State within 1 calendar day from occurrence and followed up with
a written report due in 15 days. The NRC estimates this to be a 2.25 labor hour cost (0.25
hours to process the phone call and 2 hours to review the written report).

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Savings for processing attestations
Section 35.290(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State, for physicians seeking to be named as an AU of
unsealed byproduct material. The NRC estimates that this will impact 51 licensees on an
annual basis with a savings of 0.5 labor hour for no longer requiring the submittal of a written
attestation with the amendment request.
Savings for removing attestation requirement for some individuals
Section 35.390(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State, for physicians seeking to be named as an AU of
unsealed byproduct material which requires a written directive for uses authorized under
§ 35.300. The NRC estimates that this will impact 25 licensees on an annual basis with a
savings of 0.5 labor hour per licensee for no longer requiring the submittal of a written
attestation with the amendment request.
Savings for processing attestations
Section 35.392(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State, for physicians seeking to be named as an AU
for the oral administration of sodium iodide I-131 requiring a written directive in quantities less
than or equal to 1.22 gigabecquerels (33 millicuries). The NRC estimates that this will impact
25 licensees on an annual basis with a savings of 0.5 labor hour for no longer requiring the
submittal of a written attestation with the amendment request.
Section 35.394(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the Agreement State, for physicians seeking to be named as an AU for the oral
administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22
Gigabecquerels (33 millicuries). The NRC estimates that this will impact 25 licensees on an
annual basis with a savings of 0.5 labor hour for no longer requiring the submittal of a written
attestation with the amendment request.
Section 35.490(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by an Agreement State, for physicians seeking to be named as an AU of a manual
brachytherapy source for the uses authorized under § 35.400. The NRC estimates that this will
impact 26 licensees on an annual basis, with a savings of 0.5 labor hour for no longer requiring
the submittal of a written attestation with the amendment request.
Section 35.690(a) would remove the requirement to obtain a written attestation for those
individuals who are certified by a specialty board whose certification process has been
recognized by the Agreement State, for physicians seeking to be named as an AU for sealed
sources for uses authorized. The NRC estimates this to impact eight licensees annually with a

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savings of 0.5 labor hour for no longer requiring the submittal of a written attestation with the
amendment request.
Saving on phone notifications
Section 35.3045(c) would reduce telephone reporting cost to the Agreement State because the
requirements for reporting an ME for permanent implant brachytherapy would be changed in
§ 35.3045(a)(2). The new requirements will not capture events that are not of significance and
will reduce the number of reportable MEs related to permanent implant brachytherapy. The
NRC estimates this to impact six licensees annually with a savings of 2.5 labor hours to process
the ME notification.
Saving on written follow-up report to the Agreement State
Section 35.3045(d) would reduce written reporting costs to the Agreement State because the
requirements for reporting an ME for permanent implant brachytherapy would be changed in
§ 35.3045(a)(2). The new requirements will not capture events that are not of significance and
will reduce the number of reportable MEs related to permanent implant brachytherapy. The
NRC estimates this to impact six licensees annually with a savings of 3 hours to process the
written report.
Regulatory Efficiency
The proposed rule includes changes that would affect regulatory efficiency in a positive, but not
easily quantifiable, manner. For example, regulatory efficiency would be enhanced by the
proposed changes made in requirements for submitting an application for a license, such as in
§ 35.50. In this section, the regulations would be changed to make it easier for a physician to
open an office by allowing the physician to be the AU and RSO on the same license application.
Additionally, the proposed rule would update, clarify, and strengthen the existing regulatory
requirements. Cost reductions would be realized by removing attestation requirements for
certain board certified individuals, modifying ME reporting criteria to insure that only significant
events would be reported, and by other proposed modifications to the regulations.
Public Health (routine)
Several proposed amendments would result in reducing the potential for radiation exposure to
patients, but it is difficult to quantify the actual number in rems reduced. An example is the
proposed change to § 35.204(b) and (e) which would require licensees to measure the Mo-99
concentration after each eluate from a Mo-99/Tc-99m generator and to report any measurement
to the NRC that exceeds the limits specified in § 35.204(a). During October 2006 through
February 2007, and again in January 2008, medical licensees reported to the NRC that
numerous generators had failed the Mo-99 breakthrough tests. One generator manufacturer
voluntarily reported 116 total elution test failures in 2008. The administration of higher levels of
Mo-99 provides no benefit and could increase the radiation exposure to the patient, as well as
have an adverse effect on nuclear medicine image quality and medical diagnosis.
Another example is the proposed requirement in § 35.41(b)(5) for licenses to have procedures
for any administration requiring a WD to include procedures for determining if an ME, as defined
in § 35.3045, has occurred. An ME could have occurred because the patient received more or

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less radiation dose than was planned, with possible detrimental effect to the patient. The timely
review and identification of an ME may result in prompt corrective actions.
4.

Presentation of Results

4.1

Benefits and Costs

This section summarizes the benefits and costs estimated for these regulatory options. To the
extent that the affected attributes could be analyzed quantitatively, the net effect of each option
has been calculated and is presented below. However, some benefits and costs could be
evaluated only on a qualitative basis.
The benefits of this proposed rule are associated with the potential reduction in unnecessary
radiation exposure to patients. Additionally, the proposed rule would update, clarify, and
strengthen the existing regulatory requirements, and thereby promote public health and safety.
Cost reductions would be realized by removing attestation requirements for certain board
certified individuals, modifying ME reporting criteria to insure that only significant events would
be reported, and by other proposed modifications to the regulations.
Exhibit 4-1 summarizes the results of the analysis by attribute. Relative to the no-action
alternative (Option 1), Option 2 would result in a net quantitative impact estimation over the
10-year analysis period of approximately $17 million at a 3 percent discount rate and $16 million
at a 7 percent discount rate.

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Exhibit 4-1
Summary Results by Attribute
at Discount Rates of 3 Percent and 10 Percent for a 10-Year Period
Total combined
Implementation
and Annual Cost
for 10-year
period at 7%
discount rate

Quantitative Attribute

One-time
Implementation
Costs

Annual
Operating
Costs

Total combined
Implementation
and Annual Cost
for 10-year
period at 3%
discount rate

Industry Costs Option 1

Industry Costs Option 2

$8,292,436

$773,661

$14,891,921

$13,726,307

$5,082,576

-$325,105

$2,309,368

$2,799,177

NRC Costs Option 1

NRC Costs Option 2

$415,359

-$76,336

-$235,799

-$120,790

Total Option 1

Total Option 2

$13,790,371

$372,220

$16,965,490

$16,404,694

Agreement States Option
1
Agreement States Option
2

4.2

Backfitting

The backfit rule (which is found in the regulations at §§ 50.109, 70.76, 72.62, 76.76, and in 10
CFR Part 52) does not apply to this final rule. Parts 30, 32, and 35 of Title 10 of CFR do not
contain a backfit requirement. Therefore, a backfit analysis is not required.
5.

Decision Rationale

Several proposed amendments would reduce the potential radiation exposure to patients; for
example, the proposed change to § 35.204(b) and (e) which would require licensees to measure
the Mo-99 concentration after each eluate from a Mo-99/Tc-99m generator and to report any
measurement that exceeds the limits specified in § 35.204(a). During October 2006 through
February 2007, and again in January 2008, medical licensees reported to the NRC that
numerous generators had failed the Mo-99 breakthrough tests. One generator manufacturer
voluntarily reported 116 total elution test failures in 2008. The administration of higher levels of
Mo-99 provides no benefit and could increase the radiation exposure to the patient as well as
have an adverse effect on nuclear medicine image quality and medical diagnosis.
Another example is the proposed requirement in § 35.41(b)(5) for licensees to have procedures
for determining if an ME, as defined in § 35.3045, has occurred. An ME could have occurred

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because the patient received more or less radiation dose than was planned for, with possible
detrimental effect to the patient.
Additional benefits of the proposed rule include allowing ARSOs to be named on a license,
which would increase the number of individuals who would be available to serve as preceptors
for individuals seeking to be appointed as RSOs or ARSOs. Also, by being named on a license,
ARSOs could more easily become RSOs on other licenses for the types of uses for which they
qualify. Another benefit is the increased flexibility for AUs to use sealed sources and devices for
manual brachytherapy for other medical uses that are not explicitly listed in the SSDR, provided
that these sources are used in accordance with the radiation safety conditions and limitations
described in the SSDR. Providing this flexibility will allow AUs to use medical judgment in
determining the medical uses of these sealed sources and devices.
The decision rationale is based on how the benefits and costs have been analyzed. Relative to
the no-action alternative, Option 2 would result in a one-time implementation cost to the industry
of approximately $8.3 million and a net annual cost to the industry of approximately $775,000.
Offsetting the net cost, the NRC determined that Option 2 would result in substantial
non-quantifiable benefits related to regulatory efficiency and public health (routine). Although
costs would be incurred as a result of the rule, the qualitative benefits associated with the rule
would outweigh its cost. The NRC determined that the rule is cost-justified because the
proposed regulatory initiatives would promote public health and safety.
6.

Implementation

Generally, the NRC allows an adequate time for a final rule to become effective. The time
would depend on the scope of the rulemaking, the availability of the conforming guidance, and
the complexity of the final rule. The NRC proposes that the final rule become effective 180 days
from its publication in the Federal Register. For this analysis, the final rule effective date is late
2015.
7.

References

•

NUREG/BR-0184, “Regulatory Analysis Technical Evaluation Handbook, Final Report,”
U.S. Nuclear Regulatory Commission, Washington, DC, January 1997.

•

NUREG/BR-0058, “Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory
Commission,” Revision 4, U.S. Nuclear Regulatory Commission, Washington, DC,
September 2004.

•

NUREG/CR-4627, "Generic Cost Estimates, Abstracts from Generic Studies for Use in
Preparing Regulatory Impact Analyses."

•

OMB Circular No. A-4, September, 17, 2003.

•

Department of Labor (U.S.), Bureau of Labor Statistics. Occupational Employment
Statistics, Occupational Employment and Wages.

Draft Regulatory Analysis
•

2011-2012 Information Digest, NUREG-1350, Volume 24.

•

NUREG-1556, Vol. 20, Appendix G: LTS Program Code Descriptions.

Page 43

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Appendix A: Regulatory Flexibility Analysis
1. Steps Taken to Mitigate Economic Impacts on Small Entities
The NRC is required by the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) as amended
by the Small Business Regulatory Enforcement Fairness Act, to consider the impact of its
rulemakings on small entities and evaluate alternatives that would accomplish regulatory
objectives without unduly burdening small entities or erecting barriers to competition. This
section describes the assessment of the small entity impacts expected to be incurred by 10
CFR Parts 30, 32, and 35 licensees as a result of the proposed rule. This analysis describes
(1) the NRC's definition of “small entities,” including "small businesses," "small governmental
jurisdictions," ”small educational institutions,” and "small organizations"; (2) what number
constitutes a "substantial number" of these entities; (3) whether "significant impacts" will be
incurred by licensees under the rule; and (4) the measures that NRC has adopted in the rule to
mitigate impacts on small entities.
1.1 Defining "Small Entities" Affected by the Rule
The NRC established its size standards for small entities on December 9, 1985 (50 FR 50241).
On November 6, 1991 (56 FR 56671), the NRC conformed its format for size standards to mirror
the definitions of small entities in the Regulatory Flexibility Act of 1980, as amended. In a direct
final rule published in the Federal Register on August 10, 2007 (72 FR 44951), the NRC
adjusted its receipts-based small business size standard to conform to the Small Business Act
(SBA) size standard for nonmanufacturing industries. This size standard reflects the most
commonly used SBA size standard for nonmanufacturing industries. On July 3, 2012, the NRC
increased its receipts-based, small business size standard from $6.5 million to $7 million to
conform to the standard set by the SBA.
The NRC uses the size standards contained in 10 CFR 2.810 to determine whether a licensee
qualifies as a small entity in its regulatory programs.
The size standards pertinent to Parts 30, 32, and 35 licensees impacted by this proposed rule
under 10 CFR 2.810 are:
A small business is a for-profit concern and is a:
(1) Concern that provides a service or a concern not engaged in manufacturing with
average gross receipts of $7 million or less over its last 3 completed fiscal years; or
(2) Manufacturing concern with an average number of 500 or fewer employees based
upon employment during each pay period for the preceding 12 calendar months.
A small organization is a not-for-profit organization which is independently owned and operated
and has annual gross receipts of $7 million or less.
A small governmental jurisdiction is a government of a city, county, town, township, village,
school district, or special district with a population of less than 50,000.

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A small educational institution is one that is supported by a qualifying small governmental
jurisdiction or is not state or publicly supported and has 500 or fewer employees.
The proposed rule will affect 7,473 NRC/Agreement State licensees. The licenses are issued
principally to medical institutions and individual private medical practitioners.
Because NRC licensees with annual gross receipts below $7 million pay reduced fees, the NRC
has data on the number of affected licensees who certified that they qualified as small entities
for reduced fee purposes. Based on data from the NRC Financial Accounting and Integrated
Management Information System in December 2012, 294 affected licensees reported that their
annual gross receipts were below $7 million. Using the ratio explained in section 3.2.1 of this
document, the NRC estimates that 1,735 NRC/Agreement State licensees are classified as
small entities.
In total, therefore, the proportion of impacted licensees that are small entities is estimated to be
23 percent.
1.2 Determining What Number Constitutes a Substantial Number
The NRC has not established a quantitative definition of the number or proportion of licensees
that constitutes a substantial number. However, for the purpose of this rulemaking, the NRC
assumes that 23 percent of all licensees constitutes a "substantial number" of small entities
likely to be impacted by this rule. A substantial number of both of the two categories of
licensees considered, medical institutions and individual private medical practitioners, would be
impacted by the rule.
1.3 Measuring "Significant Impacts"
To evaluate the impact that a small entity would be expected to incur as a result of the rule, the
ratio of annualized costs was calculated as a percentage of estimated gross receipts. The NRC
has not established a quantitative cutoff for "significant impact." For the purpose of this
rulemaking, the NRC assumes "significant" impact if the ratio of annualized costs to estimated
annual gross receipts for a licensee exceeds one percent.
The proposed rule would have an estimated $8.3 million implementation cost impact on the
industry. This cost would be spread over the 7,473 impacted licensees or an average
implementation cost of approximately $1,100 per licensee. The proposed rule would have an
annual cost impact on the industry as well of an estimated $750,000 or an average cost of an
estimated $100 per licensee.
The NRC assumes that all affected licensees have annual revenues greater than $110,000;
therefore the estimated cost impacts do not exceed the one percent criterion for "significant
impacts." Thus, even though the proposed rule would affect a substantial number of licensees
that are small entities it would not have a significant economic impact on these entities.

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1.4 Steps Taken to Mitigate Economic Impacts on Small Entities
The NRC has taken a number of actions in this rule to ensure that the selected alternative is the
least costly alternative that adequately protects workers and patients from radiation exposure.
As the Regulatory Analysis prepared for this rule demonstrates, many of the proposed
amendments eliminate existing costs, and the remaining proposed amendments which would
add cost would not place a significant economic impact on small entities.

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Appendix B: Assumptions by section determining impacted NRC licensees.
The below table outlines by section the assumptions which determined the number of impacted
NRC licensees. To obtain the number of licensees impacted in the Agreement States, use a
multiplier of 5.9, which is the ratio of NRC licensees to Agreement State licensees from Table
1 - Number and Type of Licenses.
Section
30.34(g)
30.50(b)
35.12(b) Add ARSOs
35.12(b) Remove copy
35.12(c)(1) Renewals
35.12(c)(1)
Amendments
35.13(d) (Turnover)
35.13(d)
(Amendments)
35.13(i)
35.14(b)(1)
35.14(b)(6)
35.24(b)
35.41(a)
35.41(b)(5)
35.41(b)(6)
35.50(a)
35.50(c)(1)
35.50(c)(3)
35.51(a)
35.55(a)
35.57(a)(1)
35.57(a)(2)
35.57(a)(3)
35.57(b)(1)
35.57(b)(2)

Annual Totals
(program code 2511) responses from the sole licensee = 9
(program code 2511) responses from the sole licensee = 9
3% of all licensees (1083) = 32
3% of all licensees (1083) = 32
10% of all licensees (1083) = 108
1 response from all licensees = 1083
3% of all licensees (1083 X 3%) = 32
10 % of all licensees (1083 X 10%) = 108
2 responses from each licensee in 2120, 2200, 2230, 2240 (507 X 2) =
1014
Turnover – 3% of all licensees (1083 X 3% = 32) + Name changes 0.5% of all licensees (1083 X 0.5% = 6) = 38 for ARSOs The number
of ophthalmic physicists is estimated to be low to calculate.
2 responses from 2120, 2200, 2230, 2240 (507 X 2) = 1014
Cost covered in 35.2024(c)
Cost covered in 35.2041 35.41(b)(5) and 35.41(b)(6) = 33
Turnover – 3% of 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310
(598 X 3% = 18
Turnover – 3% of 2110, 2120, 2200, 2240 (489 X 3% = 15)
30% of all applicants will be board certified. Turnover - 3% of all
licensees (1083) =32 X 30% = 10 (rounded)
Subset of 35.50(a)
1 responded from 2201 (286) = 1
30% of all applicants will be board certified. Turnover – 3% of 2110,
2120, 2200, 2210, 2230, 2231, 2240, 2310 (598) =18 X 30% = 5
(rounded)
10% of all applicants are board certified. 15% of 2110 and 2120 have
ANP (405 X 10% = 41 X 15%) = 6 Turnover – 3% X 6 = 1
1% of 2210, 2120, 2200, 2210, 2230, 2231, 2240, 2310 (598) = 6
1% of all licensees (1083) = 11
1% of 2210, 2120, 2200, 2210, 2230, 2231, 2240, 2310 (598) = 6
30% of all licensees (1083) = 325
2.5% of all licensees (1083) = 27

Draft Regulatory Analysis

35.65(b((2)
35.190(a)
35.204(b)
35.204(e)
35.290(a)
35.390(a)
35.392(a)
35.394(a)
35.433
35.490(a)
35.610(d)
35.655(a)
35.690(a)
35.2024(c)
35.2041
35.2204
35.2310
35.3045(a)(2)
35.3045(c)
35.3045(d)
35.3045(e)
35.3204(a)
35.3204(b)

Page 48

One time cost -1% of 2110, 2120, 2121, 2200, 2201, 2220, 2231 (950)
= 10
Annual cost - 0.15% of 2110, 2120, 2121, 2200, 2201, 2220, 2231
(950) = 1.5
30% of all applicants will be board certified. Turnover – 3% of 2110,
2120, 2121, 2200, 2201, 2220 (948) = 28 X 30% = 8 (rounded)
Covered under 35.2204 for 2110, 2120 = 405 X 15% = 61 Related to
the number of ANP [see 35.55(a)]
10% of 2110, 2120, 2121,2200, 2201, 2220, 2231 (950) have
generators = 95 X 1% estimated to report = 1
30% of all applicants will be board certified. Turnover – 3% of 2110,
2120, 2121, 2200, 2201, 2220 (948) = 28 X 30% = 8 (rounded)
30% of all applicants will be board certified. Turnover – 3% of 2110,
2120, 2200, 2231 (465) = 14 X 30% = 4 (rounded)
30% of all applicants will be board certified. Turnover – 3% of 2110,
2120, 2200, 2231 (465) = 14 X 30% = 4
30% of all applicants will be board certified. Turnover – 3% of 2110,
2120, 2200, 2231 (465) = 14 X 30% = 4
No Additional Cost
30% of all applicants will be board certified. Turnover - 3% of 2110,
2120, 2200, 2210, 2240 (503) = 15 X 30% = 5
Cost in 35.2310 for 2110, 2120, 2230, 2300, 2310 = 498
No change in cost
30% of all applicants will be board certified. Turnover - 3% of 2110,
2230, 2300, 2310 (160) = 5 X 30% = 2 (rounded)
Turnover – 3% of all licensees = 32
From 35.41(a) = 33
From 35.204(b) = 61
From 35.610(d) = 498 X 5% = 25
Cost in 35.3045(c), (d) and (e)
Avg number of ME’s each year for permanent implant brachytherapy
= 14 X 50% reduction from new criterion = 7 (1 NRC and 6 Agreement
States)
Avg number of ME’s each year for permanent implant brachytherapy
= 14 X 50% reduction from new criterion = 7 (1 NRC and 6 Agreement
States)
Avg number of ME’s each year reported to patients = 48 X 35%
reduction from new criterion = 18 (3 NRC and 15 Agreement States)
10% of 2110, 2120, 2121,2200, 2201, 2220, 2231 (950) have
generators = 95 X 1% estimated to report = 1
10% of 2110, 2120, 2121,2200, 2201, 2220, 2231 (950) have
generators = 95 X 1% estimated to report = 1

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File Created	2013-08-23