33046 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Rules and Regulations 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Parts 30, 32, and 35 

[NRC–2008–0175] 

RIN 3150–AI63 

Medical Use of Byproduct Material— 

Medical Event Definitions, Training and 

Experience, and Clarifying 

Amendments 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Final rule. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) is amending its 

regulations related to the medical use of 

byproduct material. The final rule will 

amend the NRC regulations related to 

the medical use of byproduct material. 

This rule amends the reporting and 

notification requirements for a medical 

event (ME) for permanent implant 

brachytherapy. This rule also amends 

the training and experience (T&E) 

requirements to remove from multiple 

sections the requirement to obtain a 

written attestation for an individual 

who is certified by a specialty board 

whose certification process has been 

recognized by the NRC or an Agreement 

State; and 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). Additionally, this rule 

amends the requirements for measuring 

molybdenum contamination; adds a 

new requirement for the reporting of 

failed technetium and rubidium 

generators; and allows licensees to name 

associate radiation safety officers 

(ARSOs) on a medical license. 

DATES: This final rule is effective on 

January 14, 2019. 

ADDRESSES: Please refer to Docket ID 

NRC–2008–0175 when contacting the 

NRC about the availability of 

information for this action. You may 

obtain publicly-available information 

related to this action by any of the 

following methods: 

• Federal Rulemaking Website: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2008–0175. Address 

questions about NRC dockets to Carol 

Gallagher; telephone: 301–415–3463; 

email: Carol.Gallagher@nrc.gov. For 

technical questions, contact the 

individual listed in the FOR FURTHER

INFORMATION CONTACT section of this 

document. 

• NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): You may obtain publiclyavailable documents online in the 

ADAMS Public Documents collection at 

http://www.nrc.gov/reading-rm/ 

adams.html. To begin the search, select 

‘‘ADAMS Public Documents’’ and then 

select ‘‘Begin Web-based ADAMS 

Search.’’ For problems with ADAMS, 

please contact the NRC’s Public 

Document Room (PDR) reference staff at 

1–800–397–4209, 301–415–4737, or by 

email to pdr.resource@nrc.gov. For the 

convenience of the reader, instructions 

about obtaining materials referenced in 

this document are provided in the 

‘‘Availability of Documents’’ section. 

• NRC’s PDR: You may examine and 

purchase copies of public documents at 

the NRC’s PDR, Room O1–F21, One 

White Flint North, 11555 Rockville 

Pike, Rockville, Maryland 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kimyata Morgan-Butler, Office of 

Nuclear Material Safety and Safeguards, 

U.S. Nuclear Regulatory Commission, 

Washington, DC 20555–0001, telephone: 

301–415–0733, email: Kimyata.MorganButler@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

A. Need for the Regulatory Action and 

Legal Authority 

The NRC is amending its regulations 

related to the medical use of byproduct 

material. These regulations were last 

amended in their entirety in 2002. Over 

the last 14 years, stakeholders and 

members of the medical community 

have identified certain issues in 

implementing these regulations. As a 

result, the NRC is updating its 

regulations to address technological 

advances and changes in medical 

procedures. The amended rule would 

also enhance patient safety. The NRC is 

revising parts 30, 32, and 35 of title 10 

of the Code of Federal Regulations (10 

CFR) under the legal authority granted 

to the NRC by the Atomic Energy Act of 

1954, as amended, and the Energy 

Reorganization Act of 1974, as 

amended. 

B. Major Provisions 

• The final rule establishes separate 

requirements for identifying and 

reporting MEs involving permanent 

implant brachytherapy. These new 

regulations require reporting of an event 

in which there is actual or potential 

harm to a patient resulting from an ME. 

Additionally, licensees are required to 

develop, implement, and maintain 

procedures for determining if an ME has 

occurred, including procedures for 

verifying certain aspects of a permanent 

implant brachytherapy treatment within 

60 days from the date the treatment was 

performed. Note that the terms ‘‘ME,’’ 

‘‘ME definition,’’ ‘‘ME criteria,’’ and 

‘‘ME reporting criteria’’ are used 

interchangeably in the Executive 

Summary and the Discussion sections of 

this document. 

• Training and experience 

requirements are amended in multiple 

sections to remove the requirement to 

obtain a written attestation for an 

individual who is certified by a 

specialty board whose certification 

process has been recognized by the NRC 

or an Agreement State. The NRC has 

determined that certification by a 

specialty board, coupled with meeting 

the recentness of training requirements, 

is sufficient to demonstrate that an 

individual seeking authorization on a 

license has met the T&E requirements 

and has the requisite current knowledge 

and, therefore, additional attestation by 

a preceptor is unnecessary. Individuals 

who are not board certified will still 

need to obtain a written attestation; 

however, the language of the attestation 

is modified. Additionally, residency 

program directors will be allowed to 

provide these written attestations. Note 

that the terms ‘‘written attestation,’’ 

‘‘attestation,’’ ‘‘preceptor statement,’’ 

and ‘‘preceptor attestation’’ are used 

interchangeably in the Executive 

Summary and the Discussion sections of 

this document. 

• The rule addresses the issues raised 

in a petition for rulemaking (PRM–35– 

20) that was submitted to the NRC in 

2006. The petition requested that 

experienced board-certified Radiation 

Safety Officers (RSOs) and medical 

physicists not named on a license who 

had practiced certain modalities prior to 

October 24, 2005, be exempt from the 

specific T&E requirements in §§ 35.50 

and 35.51, respectively. In effect, they 

will be ‘‘grandfathered’’ for these 

training requirements for the modalities 

that they practiced as of October 24, 

2005. This petition is discussed in detail 

in Section II., Petition for Rulemaking, 

PRM–35–20, of this document. 

• The requirements for measuring the 

molybdenum-99 (Mo-99) concentration 

for elutions of Mo-99/Technetium-99m 

(Tc-99m) generators are changed and 

requirements are added for reporting 

and notification of a generator eluate 

exceeding permissible Mo-99, 

strontium-82 (Sr-82), or strontium-85 

(Sr-85) concentrations. The occurrence 

of generator eluate exceeding 

permissible concentrations is also 

referred to as ‘‘breakthrough.’’ The 

current requirement to measure the Mo99 concentration after the first eluate is 

changed to require that the Mo-99 

concentration be measured in each 

eluate. This requirement is changed in 


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response to several breakthrough 

incidents reported to the NRC. 

• Additionally, licensees will be 

allowed to appoint a qualified 

individual with expertise in certain uses 

of byproduct material to be named on a 

license to serve as an ARSO. This will 

make it easier for an individual to 

become an RSO on other medical 

licenses and will increase the number of 

individuals who are available to serve as 

preceptors for individuals seeking to be 

appointed as RSOs or ARSOs. 

C. Costs and Benefits 

The NRC has not established a 

quantitative cutoff for defining an 

economically significant regulatory 

action for the purposes of the 

Congressional Review Act. The NRC 

assumes ‘‘significant’’ impact if the ratio 

of annualized costs to estimated annual 

gross revenues for a licensee exceeds 1 

percent. The final rule will have an 

estimated $7.8 million implementation 

cost for the medical community. This 

cost will be spread over the 7,418 

impacted licensees for an average 

implementation cost of approximately 

$1,100 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 1 percent criterion for 

‘‘significant’’ impacts, and the final rule 

is not considered an economically 

significant regulatory action. It will cost 

the NRC approximately $65,000 to 

implement this rule. 

The benefits of this final rule are 

associated with reducing unnecessary 

radiation exposure to patients, removing 

the requirement to obtain a written 

attestation for an individual who is 

certified by a specialty board whose 

certification process has been 

recognized by the NRC or an Agreement 

State, and affording greater flexibility to 

licensees. This final rule also updates, 

clarifies, and strengthens the existing 

regulatory requirements, and, thereby, 

promotes public health and safety. 

A regulatory analysis has been 

developed for this rulemaking and is 

discussed in Section VIII., Regulatory 

Analysis, of this document. 

Table of Contents 

I. Background 

II. Petition for Rulemaking, PRM–35–20 

III. Discussion 

A. What action is the NRC taking? 

B. When will these actions become 

effective? 

IV. Opportunities for Public Participation 

V. Public Comment Analysis 

VI. Section-by-Section Analysis 

VII. Regulatory Flexibility Certification 

VIII. Regulatory Analysis 

IX. Backfitting and Issue Finality 

X. Cumulative Effects of Regulation 

XI. Plain Writing 

XII. Environmental Impact: Categorical 

Exclusion 

XIII. Environmental Assessment and Final 

Finding of No Significant Environmental 

Impact 

XIV. Paperwork Reduction Act Statement 

XV. Congressional Review Act 

XVI. Criminal Penalties 

XVII. Coordination With NRC Agreement 

States 

XVIII. Agreement State Compatibility 

XIX. Coordination With the Advisory 

Committee on the Medical Uses of 

Isotopes 

XX. Consistency With Medical Policy 

Statement 

XXI. Voluntary Consensus Standards 

XXII. Availability of Guidance 

XXIII. Availability of Documents 

I. Background 

The NRC published a final rule in the 

Federal Register on April 24, 2002 (67 

FR 20250), that revised the medical use 

regulations in 10 CFR part 35 in their 

entirety. The T&E requirements in 10 

CFR part 35 were further revised 

through an additional rulemaking, 

‘‘Medical Use of Byproduct Material— 

Recognition of Specialty Boards,’’ 

published in the Federal Register on 

March 30, 2005 (70 FR 16336). 

In implementing the current 

regulations in 10 CFR part 35, 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. As a result, the NRC is 

amending its regulations in 10 CFR part 

35 to address these issues. This final 

rule modifies the written directive (WD) 

requirements in § 35.40 and the ME 

reporting requirements in § 35.3045 to 

establish separate ME reporting criteria 

for permanent implant brachytherapy. 

This final rule also modifies the 

requirements for procedures for 

administrations requiring a WD in 

§ 35.41 to require licensees to develop 

written procedures for determining if an 

ME has occurred as a result of any 

administrations requiring a WD, 

including permanent implant 

brachytherapy. The NRC’s purpose for 

requiring licensees to report MEs is to 

allow the NRC to follow up on incidents 

and determine if other licensees might 

be making the same or similar mistakes, 

or experiencing the same or similar 

challenges. When the NRC identifies 

similarities in the problems reported 

from multiple facilities, it can provide 

information that may help prevent 

additional incidents. The information 

collected is also valuable in assessing 

trends or patterns, identifying generic 

issues, and recognizing any 

inadequacies or unreliability of specific 

equipment or procedures. 

Currently, the ME criteria for 

brachytherapy implants in § 35.3045, 

‘‘Report and notification of a medical 

event,’’ are based on the dose 

administered to the patient. The ME 

criteria amendments establish separate 

ME criteria for permanent implant 

brachytherapy in terms of the total 

source strength administered (activitybased) rather than the dose delivered 

(dose-based). The ME criteria 

amendments in this final rule are based 

on the NRC staff recommendations 

contained in SECY–12–0053, 

‘‘Recommendations on Regulatory 

Changes for Permanent Implant 

Brachytherapy Programs,’’ and the 

comments received on the proposed 

rule ‘‘Medical Use of Byproduct 

Material—Medical Event Definitions, 

Training and Experience, and Clarifying 

Amendments,’’ published in the Federal 

Register on July 21, 2014 (79 FR 42410). 

The staff has concluded that dose-based 

criteria are problematic for permanent 

implant brachytherapy because 

absorbed dose can be challenging to 

calculate resulting in clinically 

acceptable therapies being reported as 

medical events. In addition, moving to 

activity-based criteria should allow for 

recognition of medical events earlier 

than dose-based criteria, thus allowing 

timelier corrective actions. 

On August 6, 2008, the NRC 

published a proposed rule, ‘‘Medical 

Use of Byproduct Material— 

Amendments/Medical Event 

Definitions,’’ in the Federal Register (73 

FR 45635), for public comment. This 

proposed rule included revised ME 

criteria for permanent implant 

brachytherapy. The majority of 

commenters were in agreement on 

converting the permanent implant 

brachytherapy ME criteria from dosebased to activity-based. However, 

during late summer and early fall of 

2008, a substantial number of MEs 

involving permanent implant 

brachytherapy were reported to the 

NRC. Based on the circumstances 

involving the MEs reported in 2008, the 

NRC staff re-evaluated the proposed rule 

that was published in 2008 and 

developed a draft re-proposed rule. 

In SECY–10–0062, ‘‘Re-proposed 

Rule: Medical Use of Byproduct 

Material—Amendments/Medical Event 

Definitions,’’ dated May 18, 2010, the 

NRC staff requested that the 

Commission approve for publication the 

draft re-proposed rule for public 

comment. Prior to a Commission 

decision on the re-proposed rule, on 

July 8, 2010, a Commission briefing was 

held on the draft re-proposed rule. The 


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presenters included a member of the 

ACMUI, a representative from the 

Organization of Agreement States 

(OAS), a physician from the American 

Brachytherapy Society, the National 

Director of the Radiation Oncology 

Program of the Department of Veterans 

Affairs, a representative from the 

American Association of Physicists in 

Medicine (AAPM), and a representative 

from Us-TOO (a support group for 

prostate cancer patients). The presenters 

urged the Commission not to publish 

the draft re-proposed rule as developed. 

They believed that MEs should be based 

on events of potential clinical 

significance and recommended that the 

NRC seek stakeholder input in revising 

this proposed rule. 

In the Staff Requirements 

Memorandum (SRM) for SECY–10– 

0062, dated August 10, 2010, the 

Commission disapproved the NRC 

staff’s recommendation to publish the 

draft re-proposed rule. The Commission 

directed the staff to work closely with 

the ACMUI and the broader medical and 

stakeholder community to develop ME 

definitions that would protect the 

interests of patients and allow 

physicians the flexibility to take actions 

that they deem medically necessary, 

while continuing to enable the agency to 

detect failures in process, procedure, 

and training, as well as any 

misapplication of byproduct materials 

by authorized users (AUs). The SRM 

also directed the NRC staff to hold a 

series of stakeholder workshops to 

discuss issues associated with the ME 

definition. For more information, 

including public comments submitted 

on the proposed rule published on 

August 6, 2008, (see Docket ID NRC– 

2008–0071 on www.regulations.gov). 

Following Commission direction, the 

NRC conducted two workshops in the 

summer of 2011. These facilitated 

workshops were held in New York, New 

York, in June 2011, and in Houston, 

Texas, in August 2011. The NRC staff 

also requested the ACMUI to prepare a 

report on ME definitions for permanent 

implant brachytherapy. In February 

2012, the ACMUI submitted its final 

revised report to the NRC. The NRC staff 

used the recommendations in the 

ACMUI revised final report, along with 

the substantial input from stakeholders, 

to develop the recommendations in 

SECY–12–0053. The recommendations 

in SECY–12–0053, along with public 

comments received on the proposed 

rule published on July 21, 2014 (79 FR 

42410), provided the regulatory basis for 

the ME reporting criteria in this final 

rule. 

In addition to revising the ME 

definitions for permanent implant 

brachytherapy, the NRC is amending its 

regulations in 10 CFR part 35 to: Revise 

the preceptor attestation requirements; 

require increased frequency of testing 

for measuring Mo-99 concentration in a 

Mo-99/Tc-99m generator; require 

reporting and notification when a 

generator eluate exceeds permissible 

Mo-99, Sr-82, or Sr-85 concentrations; 

allow ARSOs to be named on a medical 

use license; extend the 5-year inspection 

frequency for a gamma stereotactic 

radiosurgery unit to 7 years; and make 

several clarifying amendments. 

Finally, this final rule addresses 

issues that were raised in PRM–35–20 

filed by E. Russell Ritenour, Ph.D., on 

behalf of the AAPM on September 13, 

2006. The petition requested that the 

training requirements for experienced 

RSOs and medical physicists in § 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 petition is 

discussed in detail in Section II., 

Petition for Rulemaking, PRM–35–20, of 

this document. This final rule completes 

action on PRM–35–20. 

II. Petition for Rulemaking, PRM–35–20 

The NRC has incorporated into this 

rulemaking the resolution of PRM–35– 

20 filed by E. Russell Ritenour, Ph.D. 

(the petitioner), dated September 10, 

2006, on behalf of the AAPM (Ritenour 

Petition). A notice of receipt and request 

for public comments on this petition 

was published in the Federal Register 

on November 1, 2006 (71 FR 64168). 

The petitioner requested that § 35.57, 

‘‘Training for experienced Radiation 

Safety Officer, teletherapy or medical 

physicist, authorized medical physicist, 

authorized user, nuclear pharmacist, 

and authorized nuclear pharmacist,’’ be 

revised to: (1) Recognize medical 

physicists certified by either the 

American Board of Radiology or the 

American Board of Medical Physics on 

or before October 24, 2005, as 

‘‘grandfathered’’ for the modalities that 

they practiced as of October 24, 2005, 

regardless of whether a medical 

physicist was named on an NRC or an 

Agreement State license as of October 

24, 2005; and (2) recognize all 

individuals certified by the named 

boards in former subpart J of 10 CFR 

part 35, which was removed from 10 

CFR part 35 in a rulemaking dated 

March 30, 2005 (70 FR 16336), as RSOs 

who have relevant timely work 

experience (even if they have not been 

formally named as an RSO). The 

petitioner requested that experienced 

board-certified RSOs and medical 

physicists not named on a license who 

had practiced certain modalities prior to 

October 24, 2005, be exempted from the 

specific T&E requirements in §§ 35.50 

and 35.51, respectively. In effect, they 

would be ‘‘grandfathered’’ for these 

training requirements for the modalities 

that they practiced on or before October 

24, 2005. The petitioner was concerned 

that as a result of the amendments to the 

T&E regulations in 2005, an individual 

could become authorized on a license 

only if he or she had been certified by 

a specialty board whose certification 

process was recognized under this 

regulation by the NRC or an Agreement 

State or was already identified on an 

existing NRC or Agreement State 

license. If the individual had been 

certified prior to the effective date for 

recognition of the certifying board but 

had not been listed on a license, he or 

she would not be ‘‘grandfathered,’’ and 

would have to obtain training through 

the so-called ‘‘alternate pathway,’’ 

which establishes specific training 

requirements for non-certified 

individuals. The petitioner did not 

believe that it was the intent of the 

Commission to deny recognition to 

individuals currently practicing or to 

minimize the importance of certification 

by a certifying board. The NRC received 

168 comments from professional 

organizations and individuals on the 

petition. The majority of the 

commenters supported the petition. 

The NRC reviewed the petitioner’s 

request and comments received on the 

petition and concluded that revisions 

made to the regulations in 2005 may 

have inadvertently affected a group of 

board-certified individuals. This group 

of board-certified individuals may now 

have to use the alternate pathway option 

to demonstrate that they meet the T&E 

requirements in 10 CFR part 35 rather 

than the certification pathway for 

recognition on an NRC license as an 

RSO or an authorized medical physicist 

(AMP). Therefore, the NRC concluded 

that the issues raised in the petition 

would be considered in the rulemaking 

process if a regulatory basis could be 

developed to support a rulemaking (73 

FR 27773; May 14, 2008). 

In October 2008, the NRC staff sent 

letters to all of the certifying boards 

whose certification processes are 

currently recognized by the NRC and to 

certifying boards previously named in 

the former 10 CFR part 35, subpart J, 

whose certification processes currently 

are not recognized by the NRC. To 

determine the scope of the medical 

community that might be negatively 

impacted by the amendments to the T&E 

regulations in 2005, the NRC asked each 

organization to provide the number and 

percentage of its currently active 

diplomates who are not grandfathered 


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under § 35.57 by virtue of not being 

named on a license or permit. The 

organizations were asked to include 

individuals who are now or may seek to 

be named as an RSO, AMP, AU, or 

authorized nuclear pharmacist (ANP) on 

an NRC or an Agreement State medical 

use license. Based on the responses, the 

NRC estimates that as many as 10,000 

board-certified individuals may have 

been affected by the 2005 T&E 

rulemaking. 

The NRC believes that these 

individuals should be eligible for 

grandfathering for the modalities that 

they practiced on or before October 24, 

2005, because their previouslyacceptable qualifications for authorized 

status should continue to be adequate 

and acceptable from a health and safety 

standpoint and thus they should be 

allowed to continue to practice using 

the same modalities. This final rule, in 

response to the petition, amends § 35.57 

to recognize all individuals who were 

previously certified by boards 

recognized under the previous 10 CFR 

part 35, subpart J, as RSOs, teletherapy 

or medical physicists, AMPs, AUs, 

nuclear pharmacists, and ANPs for the 

modalities that they practiced on or 

before October 24, 2005. 

In his support for grandfathering the 

RSOs who have relevant work 

experience and were not formally 

named on an NRC or an Agreement 

State license or permit as an RSO, the 

petitioner stated that these individuals 

will be required to provide preceptor 

attestations. In this rulemaking, the NRC 

has eliminated the requirement for 

preceptor attestations for individuals 

certified by NRC- or Agreement Staterecognized boards. The NRC believes 

that attestations are not necessary in this 

particular situation because the 

provisions of § 35.59, ‘‘Recentness of 

training,’’ require that the T&E must 

have been obtained within the 7 years 

preceding the date of application, or the 

individual must have had related 

continuing education and experience 

since the required T&E was completed. 

The ‘‘grandfathered’’ individuals will 

fall under the provisions of § 35.59 and 

will need to provide evidence of 

continued education and experience. 

Therefore, the NRC believes that 

preceptor attestations are not necessary 

for these ‘‘grandfathered’’ individuals as 

long as the provisions of § 35.59 are met, 

and the individual only requests 

authorizations for the modalities the 

individual practiced on or before 

October 24, 2005. 

III. Discussion 

A. What action is the NRC taking? 

In implementing the current 

regulations in 10 CFR part 35, the NRC 

staff, stakeholders, and the ACMUI 

identified numerous issues that need to 

be addressed through the rulemaking 

process. The NRC published a proposed 

rule on July 21, 2014 (79 FR 42410), for 

a 120-day public comment period to 

address these issues. The NRC 

developed this final rule based on the 

comments received on the proposed 

rule. The comments are discussed in 

Section V., Public Comment Analysis, of 

this document. 

The final rule clarifies the current 

regulations and provides greater 

flexibility to licensees without 

compromising patient, worker, or public 

health and safety. The amendments in 

this final rule include: 

1. Adding separate ME definitions for 

permanent implant brachytherapy; 

2. amending preceptor attestation 

requirements; 

3. grandfathering certain boardcertified individuals, as discussed in 

Section II., Petition for Rulemaking, 

PRM–35–20, of this document; 

4. requiring increased frequency of 

testing to measure Mo-99 breakthrough; 

5. requiring reporting and notification 

when a generator eluate exceeds 

permissible concentrations of Mo-99, Sr82, Sr-85; 

6. allowing ARSOs to be named on a 

medical use license; and 

7. additional issues and clarifications. 

The major revisions are: 

a. Adding Separate ME Definitions for 

Permanent Implant Brachytherapy 

This final rule establishes separate 

ME definitions and reporting 

requirements for permanent implant 

brachytherapy. The staff has concluded 

that dose-based criteria are problematic 

for permanent implant brachytherapy 

because absorbed dose can be 

challenging to calculate resulting in 

clinically acceptable therapies being 

reported as medical events. In addition, 

moving to activity-based criteria should 

allow for recognition of medical events 

earlier than dose-based criteria, thus 

allowing timelier corrective actions. As 

explained in Section I, Background, of 

this document, these amendments are 

based on the recommendations 

developed in close cooperation with the 

ACMUI, with substantial input from 

various stakeholders, and from public 

comments received on the proposed 

rule. During its meeting in March 2004, 

the ACMUI discussed the inadequacy of 

the definition of MEs as applied to 

permanent implant brachytherapy. The 

ACMUI explained that for these 

implants, the plus or minus 20 percent 

variance from the WD criteria in the 

existing rule was only appropriate if 

both the WD and the variance could be 

expressed in units of activity, rather 

than in units of dose. The ACMUI 

explained that there is no suitable 

clinically used dose metric available for 

judging the occurrence of MEs for 

permanent implant brachytherapy. In 

June 2005, the ACMUI recommended 

that new language be developed to 

define MEs for permanent implant 

brachytherapy. 

Based on the recommendations from 

the ACMUI, the NRC staff submitted a 

paper to the Commission, SECY–05– 

0234, ‘‘Adequacy of Medical Event 

Definitions in § 35.3045, and 

Communicating Associated Risks to the 

Public,’’ dated December 27, 2005. In 

this paper, the NRC staff recommended 

that the Commission approve, for 

permanent implant brachytherapy, the 

NRC staff’s plan to revise the ME 

definitions in § 35.3045 and the 

associated requirements for WDs in 

§ 35.40 to be activity-based, instead of 

dose-based. In the SRM for SECY–05– 

0234, dated February 15, 2006, the 

Commission directed the NRC staff to 

proceed directly with the development 

of a proposed rule to modify both the 

WD requirements in § 35.40(b)(6) and 

the ME reporting requirements in 

§ 35.3045 for permanent implant 

brachytherapy medical use, to convert 

from dose-based to activity-based ME 

criteria. 

As discussed in Section I., 

Background, of this document, a 

proposed rule was published in the 

Federal Register on August 6, 2008 (73 

FR 45635). A substantial number of MEs 

were reported in 2008 that would not 

have met the criteria for reporting under 

the activity-based ME reporting criteria 

as noticed in the proposed rule. 

Therefore, the NRC staff drafted a 

different rule that contained absorbed 

dose-based ME reporting criteria for the 

treatment site. The NRC staff submitted 

recommendations for ME reporting 

criteria to the Commission in SECY–10– 

0062, ‘‘Reproposed Rule: Medical Use of 

Byproduct Material—Amendments/ 

Medical Event Definitions,’’ dated May 

18, 2010. In the SRM for SECY–10– 

0062, dated August 10, 2010, the 

Commission disapproved the NRC 

staff’s recommendations and directed 

the NRC staff to work closely with the 

ACMUI and the broader medical and 

stakeholder community to develop ME 

definitions and to hold a series of 

stakeholder workshops to discuss issues 

associated with the MEs. 


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Subsequently, during the ACMUI 

meeting held on October 20, 2010, the 

ACMUI unanimously approved its 

interim report, ‘‘Advisory Committee on 

Medical Uses of Isotopes Permanent 

Implant Brachytherapy Interim Report,’’ 

dated October 20, 2010. The ACMUI 

meeting held in April 2011 was devoted 

to issues associated with the ME 

definition. The meeting was webcast, 

providing an opportunity for further 

public involvement on this issue. 

The ACMUI submitted its final report 

on permanent implant brachytherapy, 

dated October 18, 2011, to the NRC 

following the ACMUI October 18, 2011, 

public teleconference meeting. The final 

report reflected the principal positions 

and recommendations provided by 

participants during the NRC public 

workshops. In particular, the report 

included the recommendation to change 

from dose-based ME criteria for the 

treatment site to source-strength based 

criteria. The final report included a 

quantitative metric, the ‘‘octant 

approach,’’ for determining that a 

distribution of implanted sources was 

irregular enough (i.e., demonstrating 

‘‘bunching’’) to consider the procedure 

as an ME. The final report also included 

a dose-related ME criterion for the 

treatment site. 

However, in a letter to the Chairman 

of the ACMUI dated November 30, 2011, 

the American Society for Radiation 

Oncology (ASTRO) expressed criticism 

of the ACMUI final report. The ASTRO 

considered the ME definition 

recommended by the ACMUI to be 

complex, difficult to regulate, and likely 

to cause confusion in practice. 

Subsequently, the ACMUI issued a 

revised final report, ‘‘Advisory 

Committee on Medical Use of Isotopes 

(ACMUI) Permanent Implant 

Brachytherapy Revised Final Report,’’ 

dated February 7, 2012. The ACMUI 

simplified the ME criteria for the 

treatment site, removing the ‘‘octant 

approach’’ and direct reference to 

absorbed dose to the treatment site. The 

revised final report was, with minor 

modifications, approved by the ACMUI 

during its public teleconference meeting 

held on February 7, 2012. The ASTRO, 

in a letter to the Chairman of the 

ACMUI, characterized this report as an 

improvement on the earlier report. 

The NRC staff used the 

recommendations in the ACMUI revised 

final report dated February 7, 2012, 

along with the substantial input from 

stakeholders gathered in the two 

facilitated public workshops and the 

three ACMUI public meetings in 2011 

and early 2012 (discussed earlier in this 

section), to develop the 

recommendations submitted to the 

Commission on April 6, 2012, in SECY– 

12–0053, ‘‘Recommendations on 

Regulatory Changes for Permanent 

Implant Brachytherapy Programs.’’ In a 

Commission meeting held April 24, 

2012, participating representatives from 

ACMUI, ASTRO, and the American 

Brachytherapy Society (ABS) endorsed 

the recommendations in SECY–12–0053 

for modification of the requirements in 

§§ 35.40 and 35.3045. The NRC notes 

that ASTRO and ABS representatives 

suggested eliminating the recommended 

criterion for ME reporting that would 

have required reporting of excessive 

dose to normal tissue structures within 

the treatment site. However, this 

ACMUI-recommended ME reporting 

criterion for normal tissue structures 

located within the treatment site was 

retained in SECY–12–0053 because the 

ACMUI and the NRC staff determined 

that there should be some form of ME 

reporting criterion for overdosing of 

normal tissue structures located within 

the treatment site. In the SRM for 

SECY–12–0053, dated August 13, 2012, 

the Commission approved the NRC staff 

recommendations. The 

recommendations are applicable to all 

permanent implant brachytherapy 

procedures using radioactive sources for 

all treatment sites. 

The proposed rule published on July 

21, 2014 (79 FR 42410) also included 

ME criteria in § 35.3045(a)(2)(iii) and 

(iv) as follows: For normal-tissue 

structures, an ME has occurred if: (a) 

For structures located outside of the 

treatment site (for example, the bladder 

or rectum for prostate implant 

treatments), the dose to the maximally 

exposed 5 contiguous cubic centimeters 

of tissue exceeds 150 percent of the 

absorbed dose prescribed to the 

treatment site in the pre-implantation 

portion of the WD; or (b) for intra-target 

normal structures, the maximum 

absorbed dose to any 5 contiguous cubic 

centimeters of tissue exceeds 150 

percent of the dose the tissue would 

have received based on the approved 

pre-implantation dose distribution. The 

size of the normal tissue, 5 cubic 

centimeters, was based on an ACMUI 

recommendation in its October 20, 

2010, report. In its recommendation, the 

ACMUI stated that the 5 contiguous 

cubic centimeters dose-volume 

specification avoids the high variation 

in dose sometimes seen in point doses 

and the ACMUI cited literature to 

support 5 cubic centimeters as being a 

relevant quantity for toxicity. In the 

proposed rule, the NRC specifically 

invited comments on the selection of 

the specified volume of the normal 

tissues located both outside and within 

the treatment site in defining MEs. 

The NRC received numerous 

comments expressing concern about the 

proposed ME criteria related to the 

absorbed dose to normal tissues located 

outside and within the treatment site. 

The commenters expressed concerns 

that they would have technical 

difficulties assessing dose to normal 

tissues located outside and within the 

treatment site. They stated that their 

treatment planning systems are not 

equipped to make such assessments. 

They believed the regulators may not be 

able to inspect such requirements. They 

stated that these requirements may 

cause confusion and result in licensees 

not performing permanent implant 

brachytherapy treatments. The 

comments are discussed in Section V., 

Public Comment Analysis, of this 

document. 

Based on public comments and 

recommendations from the ACMUI, the 

ME criteria in this final rule for 

permanent implant brachytherapy in 

§ 35.3045(a)(2) do not include absorbed 

doses to normal tissues located outside 

of or within the treatment site. Instead, 

the ME criteria in the final rule for 

permanent implant brachytherapy are: 

(1) An ME has occurred if the total 

source strength administered differs by 

20 percent or more from the total source 

strength documented in the postimplantation portion of the WD; 

(2) An ME has occurred if the total 

source strength administered outside of 

the treatment site exceeds 20 percent of 

the total source strength documented in 

the post-implantation portion of the 

WD; or 

(3) An ME has occurred if an 

administration involves: (a) Using the 

wrong radionuclide, (b) delivery to the 

wrong individual or human research 

subject, (c) sealed source(s) implanted 

directly into a location discontiguous 

from the treatment site as documented 

in the post-implantation portion of the 

WD (as discussed in this document, 

discontiguous means a location that is 

not physically adjacent to the treatment 

site), or (d) a leaking sealed source 

resulting in a dose that exceeds 0.5 Sv 

(50 rem) to an organ or tissue. 

In supporting these recommendations, 

the NRC believes that source strength is 

the appropriate measurable metric for 

defining MEs involving permanent 

implant brachytherapy. The 20 percent 

variance threshold is consistent with the 

recommendation of the ACMUI for all 

medical uses of byproduct material as 

described in SECY–05–0234, discussed 

earlier in this section. 

Another ME criterion included in the 

proposed rule published on July 21, 


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2014 (79 FR 42410), was related to 

source(s) implanted directly into the 

wrong site or body part (i.e., not in the 

treatment site identified in the WD). 

This criterion stated that ‘‘even a single 

sealed source directly delivered to the 

wrong treatment site would constitute 

an ME that must be reported.’’ The NRC 

received several comments on this 

issue. The commenters believed a single 

source delivered outside the treatment 

site was an inappropriate criterion for 

ME reporting. They proposed that in 

order to capture instances where a 

source is implanted in a distinctly 

wrong location (for example, left breast 

versus the right breast), the criterion 

should say, ‘‘Even a single sealed source 

directly delivered to a noncontiguous 

wrong treatment site would constitute 

an ME that must be reported.’’ 

In response to these comments and a 

recommendation from the ACMUI in its 

final report on the draft final rule 

(‘‘Advisory Committee on the Medical 

Uses of Isotopes Comments on the Draft 

Final Rule, 10 CFR parts 30, 32, and 35, 

Final Report,’’ dated January 6, 2016), 

the NRC has changed 

§ 35.3045(a)(2)(v)(C) [redesignated as 

§ 35.3045(a)(2)(iii)(C)] to read ‘‘Sealed 

source(s) implanted directly into a 

location discontiguous from the 

treatment site as documented in the 

post-implantation portion of the written 

directive.’’ 

This ‘‘wrong treatment site’’ ME 

criterion will capture cases in which 

total source strength administered 

outside of the treatment site did not 

exceed 20 percent of the total source 

strength documented in the postimplantation portion of the WD, but one 

or more sources were directly implanted 

into a location far from the treatment 

site. For example, in a case in which 

100 sources were implanted, 81 were 

within the treatment site, 18 sources 

were outside and contiguous to the 

treatment site, and one source was 

erroneously implanted directly into a 

site discontiguous from the treatment 

site. This would not be an ME under the 

‘‘exceeds 20 percent of the total source 

strength’’ criterion; but would be an ME 

because one source met the ‘‘wrong 

treatment site’’ criterion. 

The proposed criterion specified in 

§ 35.3045(a)(2)(v)(E), ‘‘a 20 percent or 

more error in calculating the total 

source strength documented in the preimplantation portion of the written 

directive,’’ in the proposed rule 

published on July 21, 2014, was not 

included in the final rule. The decision 

not to include this criterion is based on 

the comments received on the proposed 

rule and is discussed in Section V., 

Public Comment Analysis, of this 

document. 

The new ME criteria for permanent 

implant brachytherapy in § 35.3045 

require amendments to §§ 35.40 and 

35.41. The previous WD requirements 

were primarily associated with 

temporary implant brachytherapy 

medical use. This final rule establishes 

separate WD requirements in § 35.40, 

‘‘Written directives,’’ that are 

appropriate for permanent implant 

brachytherapy. This rule requires that 

the WD for permanent implant 

brachytherapy consist of two portions. 

The first portion of the WD must be 

prepared before the implantation, and 

the second portion of the WD must be 

completed after the procedure but 

before the patient leaves the posttreatment recovery area. For permanent 

implant brachytherapy, this rule 

requires that the WD portion prepared 

before the implantation include 

documentation of the treatment site, the 

radionuclide, and the total source 

strength. This final rule requires that the 

post-implantation portion of the WD 

contain documentation of the treatment 

site, the number of sources implanted, 

the total source strength implanted, and 

the date. 

Based on ACMUI input discussed 

earlier in this section and information 

gained at public workshops, the NRC 

understands that the final WD for these 

permanent implants must allow for 

unanticipated medical situations 

encountered during the procedure. For 

instance, an AU might need to adjust 

the number of sources implanted 

because the volume of the treatment site 

may have decreased since the treatment 

plan was developed. Therefore, in 

defining an ME involving the treatment 

site for permanent implants, the NRC 

based the criterion for an ME on the 

percentage of implanted sources that are 

outside the treatment site as 

documented in the post-implantation 

portion of the WD rather than by 

defining an ME based on a comparison 

of the implanted total source strength to 

the total source strength documented in 

the pre-implantation portion of the WD. 

This definition differs from the ME 

definition for all other brachytherapy 

procedures where dose comparisons are 

made with reference to what was 

prescribed in the WD that was prepared 

before the procedure. 

This final rule also makes changes to 

§ 35.41, ‘‘Procedures for administrations 

requiring a written directive,’’ to 

include permanent implant 

brachytherapy. Although § 35.41(a)(2) 

requires licensees to determine if the 

administration is in accordance with the 

WD, there is no specific requirement 

that a licensee determine that an 

administered dose or dosage met an ME 

criterion as defined in § 35.3045. 

Section 35.41 is amended to require that 

a licensee develop procedures for 

determining if an ME has occurred. For 

all permanent implant brachytherapy, 

§ 35.41 is also amended to require that 

a licensee develop additional 

procedures to include an evaluation of 

the placement of sources as documented 

in the post-implantation portion of the 

WD. The procedures must include a 

provision that these assessments must 

be made within 60 days from the date 

the treatment was performed. Although 

there is no requirement in § 35.41 to use 

imaging to determine the occurrence of 

an ME, imaging is the best (and in some 

circumstances may be the only) method 

to determine source strength outside of 

the treatment site and is routinely 

practiced in most clinical facilities. 

b. Amending Preceptor Attestation 

Requirements 

The current regulations in 10 CFR 

part 35 provide three pathways for 

individuals to satisfy T&E requirements 

to be approved as an RSO, AMP, ANP, 

or AU. These pathways are: (1) 

Approval of an individual who is 

certified by a specialty board whose 

certification process has been 

recognized by the NRC or an Agreement 

State (certification pathway); (2) 

approval based on an evaluation of an 

individual’s T&E (alternate pathway); or 

(3) identification of an individual’s 

approval on an existing NRC or 

Agreement State license. 

Under the certification and the 

alternate pathway, an individual 

seeking authorization for medical 

byproduct material must obtain a 

written attestation signed by a preceptor 

with the same authorization. The 

attestation must state that the individual 

has satisfactorily completed the 

necessary T&E requirements and has 

achieved a level of competency 

sufficient to function independently in 

the position for which authorization is 

sought. 

During a Commission briefing held on 

April 29, 2008, the ACMUI 

recommended that the attestation 

requirements be revised. The ACMUI 

expressed concern that the existing 

requirements have had unintended 

consequences that, if not corrected, 

would impact the availability of 

authorized individuals. In other words, 

there would likely be a shortage of 

authorized individuals to provide 

medical care as a result of the reluctance 

of preceptors to sign attestations. The 

ACMUI recommended that attestations 

be eliminated for the board certification 


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pathway. In the ACMUI’s view, by 

meeting the board requirements, a 

curriculum and a body of knowledge 

can be defined, and progress toward 

meeting defined requirements can be 

measured. Further, the ACMUI asserted 

that a board certification indicates that 

the T&E requirements have been met, 

and the Maintenance of Certification 

provides ongoing evidence of current 

knowledge. Therefore, the ACMUI 

asserted that an additional attestation 

for the board-certified individuals was 

not needed. 

The ACMUI also recommended that 

the attestation requirements associated 

with the alternate pathways be amended 

to delete the requirement to attest to an 

individual’s radiation safety-related 

competency. The reason for the 

recommendation was that the ACMUI 

believed that signing an attestation of 

competence results in a perceived risk 

of personal liability on the part of the 

individual signing the attestation and 

that preceptors are reluctant to accept 

this risk. 

In addition, the ACMUI 

recommended that the attestation 

submitted under the alternate pathway 

be considered acceptable if it is 

provided by a residency program 

director representing a consensus of an 

authoritative group, irrespective of 

whether the program director personally 

met the requirements for AU status. The 

ACMUI advised that training of 

residents is a collective process and 

entails the collective judgment of an 

entire residency program faculty, 

whereas preceptor attestation is an 

individual process, and an individual 

preceptor typically would provide only 

a small portion of the T&E. 

Following the April 29, 2008, 

Commission briefing, in an SRM dated 

May 15, 2008, the Commission directed 

the NRC 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 

the alternate pathway. The Commission 

also directed the NRC staff to consider 

additional methods, such as having the 

attestation provided by consensus of an 

authoritative group. 

Following both consideration of the 

ACMUI’s position, which was 

consistent with its long-held position on 

this issue, and interactions with the 

Agreement States, the NRC staff 

provided its recommendations on this 

issue to the Commission on November 

20, 2008, in SECY–08–0179, 

‘‘Recommendations on Amending 

Preceptor Attestation Requirements in 

10 CFR part 35, Medical Use of 

Byproduct Material.’’ The NRC staff 

recommended that the Commission 

approve development of the following 

amendments to the 10 CFR part 35 

attestation requirements: (1) Eliminate 

the attestation requirement for 

individuals seeking authorized status 

via the board certification pathway; (2) 

retain the attestation requirement for 

individuals seeking authorized status 

via the alternate pathways; however, 

replace the text stating that the 

attestation demonstrates that the 

individual ‘‘has achieved a level of 

competency to function independently’’ 

with alternative text such as ‘‘has 

demonstrated the ability to function 

independently’’ to fulfill the radiation 

safety-related duties required by the 

license; and (3) accept attestations from 

residency program directors, 

representing consensus of residency 

program faculties as long as at least one 

member of the residency program 

faculty is an authorized individual in 

the same category as that requested by 

the applicant seeking authorized status. 

In an SRM dated January 16, 2009, to 

SECY–08–0179, the Commission 

approved these recommendations and 

directed the NRC staff to develop the 

proposed rule language for the 

attestation requirements for the alternate 

pathway in concert with the ACMUI 

and the Agreement States. 

Participants at public workshops held 

in the summer of 2011 broadly 

supported the proposed changes to 

remove the attestation requirement for 

board-certified individuals. The 

workshop panelists (which included 

members of the ACMUI and the 

Agreement States) recommended that 

the NRC remove the requirement for 

attestation for board-certified 

individuals. They believed that board 

certification coupled with the 

recentness of training requirements 

should be sufficient for the regulator’s 

needs. With regard to the language of 

attestation (for the alternate pathway), 

they believed that the preceptors should 

not attest to someone’s competency; 

rather, they should attest that the 

individuals received the T&E that is 

necessary to carry out one’s 

responsibility independently. At the 

April 2011 ACMUI meeting, the ACMUI 

advised that the attestation language 

should be revised to say that the 

individual has received the requisite 

T&E to fulfill the radiation safety-related 

duties required by the license. In the 

final rule, the attestation language is 

revised accordingly. 

The final rule amends T&E 

requirements in multiple sections of 10 

CFR part 35 with regard to the 

attestation requirements in accordance 

with the NRC staff’s recommendations 

in SECY–08–0179. 

c. Extending Grandfathering to Certain 

Certified Individuals (PRM–35–20) 

The petition and its resolution are 

discussed in Section II., Petition for 

Rulemaking, PRM–35–20, of this 

document. 

d. Requiring Increased Frequency of 

Testing To Measure Mo-99 

Breakthrough 

When Tc-99m is eluted from a Mo-99 

generator, Mo-99 could be co-eluted 

along with technetium. This is termed 

‘‘molybdenum breakthrough.’’ Current 

regulations in § 35.204(a) prohibit a 

licensee from administering a 

radiopharmaceutical to humans that 

exceeds 0.15 microcuries of Mo-99 per 

millicurie of Tc-99m. Section 35.204(b) 

requires that a licensee that uses Mo-99/ 

Tc-99m generators for preparing a Tc99m radiopharmaceutical measure the 

Mo-99 concentration of the first eluate 

to demonstrate compliance with the 

specified concentrations. However, a 

generator can be eluted several times to 

obtain Tc-99m for formulating 

radiopharmaceuticals for patient use. 

If Mo-99 breakthrough exceeds the 

permissible concentration listed in 

§ 35.204(a), it may cause unnecessary 

radiation exposures to patients. The 

administration of higher levels of Mo-99 

could potentially affect health and 

safety and have an adverse effect on 

nuclear medicine image quality and 

medical diagnosis. 

Generator manufacturers have always 

recommended testing each elution prior 

to use in humans. Before 2002, § 35.204 

required a licensee to measure the Mo99 concentration of each eluate. 

However, the NRC revised § 35.204 in 

April 2002 because the medical and 

pharmaceutical community considered 

frequency of Mo-99 breakthrough to be 

a rare event. Therefore, the Commission 

decided that measuring only the first 

elution from a generator was necessary 

to detect manufacturing issues or 

generators that may have been damaged 

in transport. 

From October 2006 to February 2007, 

and again in January 2008, medical 

licensees reported to the NRC that 

numerous generators had failed the Mo99 breakthrough tests. Some licensees 

reported the failed tests in the first 

elution, while some reported an 

acceptable first elution but failed 

subsequent elutions. One generator 

manufacturer voluntarily reported 116 

total elution test failures in 2008. Based 

upon the numerous reports of failed Mo99 breakthrough measurements noted in 


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the subsequent elutions, the NRC is 

amending § 35.204 to return to the pre2002 performance standard, which 

required licensees to measure the Mo-99 

concentration for each elution of the 

Mo-99/Tc-99m generator at the time of 

generator elution. 

e. Requiring Reporting and Notification 

of Generator Eluates Exceeding 

Permissible Concentrations of 

Molybdenum-99, Strontium-82, or 

Strontium-85 

The regulations do not currently 

require reporting to the NRC when an 

elution from a Mo-99/Tc-99m or Sr-82/ 

Rb-82 generator exceeds the regulatory 

limit in § 35.204(a). As discussed in this 

section, eluates from Mo-99/Tc-99m 

generators exceeded the permissible 

concentration listed in § 35.204(a) on 

numerous occasions in 2006, 2007, and 

2008. Additionally, in 2011, issues with 

Sr-82/Rb-82 generators were discovered 

when several individuals were 

identified with unexpectedly high levels 

of Sr-82 and Sr-85. These individuals 

had undergone Rb-82 chloride cardiac 

scanning procedures several months 

prior and had received these 

radionuclides in levels greatly in excess 

of the administration levels permitted in 

§ 35.204 for Sr-82/Rb-82 generators. 

Further investigations showed that at 

least 90 individuals at one facility and 

25 at another facility received levels of 

Sr-82 or Sr-85 that exceeded the levels 

permitted in § 35.204. Of these patients, 

at least three had levels of Sr-82 and Sr85 high enough to result in reportable 

MEs as defined in § 35.3045. 

Because the reporting of a generator 

when the eluate exceeded permissible 

concentrations was voluntary, the NRC 

had difficulty determining the extent of 

potential problems. Reporting of results 

in excess of the levels in § 35.204 for the 

Sr-82/Rb-82 generators could have 

alerted users and regulators to issues 

associated with these generators and 

possibly reduced the number of patients 

exposed to excess levels of Sr-82 and Sr85. Breakthrough of Mo-99, or Sr-82 and 

Sr-85 contaminants can lead to 

unnecessary radiation exposure to 

patients. 

This final rule also adds a new 

reporting requirement for a generator 

eluate exceeding permissible 

concentrations of Mo-99 or Sr-82 and 

Sr-85. This new reporting requirement 

in § 35.3204(a) requires a licensee to 

report to the NRC and the manufacturer 

or distributor of medical generators 

within 7 calendar days any 

measurement that exceeds the limits in 

§ 35.204(a), at the time of generator 

elution. 

f. Allowing ARSOs To Be Named on a 

Medical Use License 

Currently, § 35.24(b) requires a 

licensee’s management to appoint an 

RSO who, in writing, agrees to be 

responsible for implementing the 

radiation protection program. Further, 

the regulations in 10 CFR part 35 do not 

allow the naming of more than one 

permanent RSO on a license. 

During an ACMUI meeting in June 

2007, ACMUI members expressed a 

concern that this restriction has 

contributed to a shortage of available 

RSOs to serve as preceptors. The 

ACMUI stated that the restriction has 

created a situation in which an 

individual who is qualified and 

performing the same duties as an RSO 

cannot be recognized or listed as an 

RSO, and that this restriction has 

created a situation in which an 

individual working as a contractor RSO 

at several hospitals or other licensed 

locations is unable to have actual dayto-day oversight at the various facilities. 

The final rule amends the regulations 

in 10 CFR part 35 to allow a licensee to 

appoint a qualified individual with 

expertise in certain uses of byproduct 

material to serve as an ARSO. This 

individual will be required to complete 

the same T&E requirements as the 

named RSO for the individual’s 

assigned sections of the radiation safety 

program. The ARSOs will have 

oversight duties for the radiation safety 

operations of their assigned sections, 

while reporting to the named RSO. The 

regulation will continue to allow a 

licensee to name only one RSO on a 

license. The RSO will continue to be 

responsible for the day-to-day oversight 

of the entire radiation safety program. 

Similarly, a licensee with multiple 

operating locations could appoint a 

qualified ARSO at each location where 

byproduct material is used; however, 

the named RSO will remain responsible 

for the overall licensed program. Under 

the final rule, the ARSO will be named 

on the license for the types of use of 

byproduct material for which this 

individual is qualified and has been 

assigned duties and tasks by the RSO. 

The NRC believes that allowing an 

ARSO to be named on a license will 

increase the number of individuals who 

will be available to serve as preceptors 

for individuals seeking to be appointed 

as RSOs or ARSOs. Also, an ARSO 

named on a license could more easily 

become an RSO on other licenses for the 

types of uses for which the ARSO is 

qualified. 

In addition, the current regulations 

allow AUs, AMPs, and ANPs to serve as 

the RSO only on the license for which 

they are listed. Because AUs, AMPs, and 

ANPs must meet the same requirements 

to serve as the RSO regardless of which 

medical use license they are identified 

on, the NRC believes that it is overly 

restrictive not to allow them to serve as 

an RSO on any medical use license. 

Therefore, a modification is made that 

will allow an AU, AMP, or ANP listed 

on any medical use license or permit to 

serve as an RSO or ARSO. This change 

will increase the number of individuals 

available to serve as RSOs and ARSOs 

on NRC medical licenses. Additionally, 

these ARSOs and RSOs could serve as 

preceptors for an individual seeking to 

be named as the RSO. 

Participants at the public workshops 

held in the summer of 2011 broadly 

supported the proposed change to allow 

an ARSO to be named on a license. The 

T&E requirements for an ARSO were 

discussed, and stakeholders strongly 

supported the NRC’s position that the 

ARSOs must meet the same 

qualifications as the RSO for their 

assigned sections of the radiation safety 

program. 

The final rule amends multiple 

sections of 10 CFR part 35 to 

accommodate the new ARSO position. 

g. Additional Issues and Clarifications 

Additional amendments are discussed 

in Section VI, Section-by-Section 

Analysis, of this document. 

B. When will these actions become 

effective? 

The final rule will become effective 

180 days from its publication in the 

Federal Register. In the proposed rule 

published on July 21, 2014, the NRC 

requested comments on whether a 180- 

day effective date for the final rule is 

sufficient to communicate the changes 

to all practitioners, and for practitioners 

to revise procedures, train on them, and 

implement the changes. The NRC 

received three comments on this 

question. These comments are discussed 

in Section V., Public Comment 

Analysis, of this document. Based on 

the comments received, the NRC has 

determined that a 180-day effective date 

is sufficient to implement the final rule. 

IV. Opportunities for Public 

Participation 

The NRC staff submitted a proposed 

rule to the Commission for approval on 

August 8, 2013, SECY–13–0084, 

‘‘Proposed Rule: Medical Use of 

Byproduct Material—Medical Event 

Definitions, Training and Experience, 

and Clarifying Amendments.’’ The 

Commission approved the NRC staff’s 

recommendation to publish the 

proposed rule, with certain changes 


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directed by the Commission, in the SRM 

to SECY–13–0084, dated, January 6, 

2014. The proposed rule (79 FR 42410) 

was published on July 21, 2014, for a 

120-day comment period that ended on 

November 18, 2014. However, the 

proposed rule inadvertently omitted the 

one-time implementation costs from the 

information collection burden estimate. 

Therefore, a correction to the proposed 

rule (79 FR 56524) was published in the 

Federal Register on September 22, 2014, 

correcting the information collection 

burden estimate and allowing the public 

30 days to comment on the information 

collection burden. 

During the comment period, the NRC 

staff held a public meeting on October 

8, 2014, to better inform stakeholders of 

the proposed amendments and the 

various methods by which to provide 

comments on the proposed rule. Also, a 

public meeting was held on February 

10, 2015, to better understand the 

comments made by Spectrum 

Pharmaceuticals. Spectrum 

Pharmaceuticals expressed concern 

about the proposed additional case work 

requirements in § 35.396 for the 

radionuclides used primarily for their 

alpha emissions and requested the NRC 

require 80 hours rather than the 

required 700 hours of specialized 

training for any physician so that an 

oncologist or a hematologist may 

administer parenteral radioactive drugs. 

Early public input on the proposed 

rule was solicited through various 

mechanisms. The proposed 

amendments and preliminary draft rule 

text were discussed at the two 

transcribed facilitated public workshops 

that were conducted in New York City, 

New York, on June 20–21, 2011; and in 

Houston, Texas, on August 11–12, 2011. 

The purpose of the workshops was to 

solicit key stakeholder input on topics 

associated with the definition of an ME, 

including the requirements for reporting 

and notifications of MEs for permanent 

implant brachytherapy, and on other 

medical issues that were being 

considered in the proposed rulemaking. 

These workshops were initiated as a 

result of the Commission’s direction to 

the NRC staff in the SRM to SECY–10– 

0062, which specified that the staff 

should work closely with the ACMUI 

and the medical community to develop 

ME definitions that would protect the 

interests of patients. The Commission 

also directed that these definitions 

should 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 

panelists for the workshops included 

representatives from the ACMUI, 

Agreement States, and professional 

societies, and a patients’ rights 

advocate. 

For certain amendments, the NRC 

posted preliminary draft rule text 

(ADAMS Accession No. ML111390420) 

for a 75-day comment period on 

www.regulations.gov. The availability of 

the draft rule language was noticed in 

the Federal Register on May 20, 2011 

(76 FR 29171). The NRC received 11 

comment letters on this preliminary 

draft rule text. These comment letters 

are also posted on www.regulations.gov 

under Docket ID NRC–2008–0175. The 

NRC staff reviewed the comments and 

considered them in developing the 

proposed rule text. 

V. Public Comment Analysis 

A. Overview of Public Comments 

The NRC received 69 comment letters 

that contained over 100 individual 

comments. The comment letters are 

posted on www.regulations.gov under 

Docket ID NRC–2008–0175. The 

commenters included several 

professional societies including the 

American Brachytherapy Society, 

American College of Radiology, Health 

Physics Society, American Academy of 

Health Physics, American Society for 

Radiation Oncology, American 

Association of Physicists in Medicine, 

Council on Radionuclides and 

Radiopharmaceuticals, the Organization 

of the Agreement States, and the 

Conference of Radiation Control 

Program Directors. Other commenters 

included individual States, practicing 

physicians, medical physicists, RSOs, 

nuclear pharmacists, individual 

members of the public, and a member of 

Congress. The NRC also received several 

comment letters after the public 

comment period closed. The NRC was 

able to consider and respond to several 

of these comments. However, two 

comment letters on the T&E 

requirements for alpha and beta emitters 

were submitted so late in the 

rulemaking process that it was not 

practical for the NRC to consider these 

comments in this rulemaking. 

For the ME criteria for permanent 

implant brachytherapy, the commenters 

generally supported the activity-based 

criteria instead of the current dosebased criteria for the treatment site. The 

commenters did not support the criteria 

related to the dose to normal tissues 

located outside the treatment site, and 

normal tissues located within the 

treatment site. The commenters also 

expressed concern with the proposed 5 

cubic centimeter volume of the normal 

tissue specification for the absorbed 

dose criteria for normal tissues. The 

commenters stated numerous practical 

difficulties in making these dose 

assessments. They stated that the 

volume of a maximally exposed 5 

contiguous cubic centimeters of normal 

tissue appears reasonable in theory. 

However, it will be difficult to 

determine in practice with current 

technology. They expressed concern 

that the treatment planning systems 

typically report dose-volume histograms 

to structures, but they do not identify 

contiguous volumes. Based on these 

concerns, this final rule ME criteria in 

§ 35.3045 does not include dose to 

normal tissues located outside, or 

within the treatment site. 

There were numerous comments on 

the compatibility category for the 

Agreement States for § 35.3045, Report 

and notification of a medical event. 

Members of the medical community 

submitted ten comments in support of 

Compatibility Category B. The OAS, the 

Conference of Radiation Control 

Program Directors (CRCPD), and all 7 of 

the Agreement States that submitted 

comments supported Compatibility 

Category C. This issue is fully discussed 

in Part I, Public Comments on the 

Specific Issues on Which the NRC 

Requested Comments. 

The commenters expressed concern 

about confusion among AUs 

surrounding the definition of ME and 

WDs related to Yttrium-90 (Y-90) 

microspheres. The NRC staff has 

determined that the use of Y-90 would 

continue to be licensed under § 35.1000, 

‘‘Other medical uses of byproduct 

material or radiation from byproduct 

material.’’ 

The commenters were generally 

supportive of the proposed regulation 

that allows for the naming of an ARSO 

on the license. 

The commenters were supportive of 

the proposed removal of attestation 

requirements for the board-certified 

individuals, and other changes to the 

attestation requirements that are 

retained for individuals applying 

through the alternate pathway. 

The commenters were not supportive 

of the proposed additional case work 

requirements for the radionuclides used 

primarily for their alpha emissions. 

They were concerned that the proposed 

regulation has the unintended 

consequence of increasing the burden of 

the work experience requirement for 

those seeking to administer therapeutic 

radiopharmaceuticals such as alpha and 

beta emitters. They indicated that it may 

prove too burdensome for certain 

practitioners, particularly those in areas 

far removed from teaching hospitals and 

urban centers, to participate in three 


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proctored cases in each of these specific 

categories. They stated that the result 

will be to limit patient access to these 

safe and effective pharmaceuticals 

among what is already a disadvantaged 

population. 

With regard to the proposed reporting 

and notification of failed Mo-99/Tc-99m 

and Sr-82/Rb-82 generators in § 35.3204, 

the commenters stated that the 30-day 

deadline to report should be shortened 

to more effectively address patient 

safety concerns. In response to this 

comment, the final rule has been 

changed to require a 7-calendar-day 

reporting and notification time for a 

failed generator. 

B. Public Comments and NRC 

Responses 

The NRC carefully considered the 

public comments in developing the final 

rule. This section summarizes the 

comments that the NRC received on the 

proposed rule and provides responses to 

these comments. Part I discusses the 

specific comments received on the 

issues on which the NRC specifically 

requested comments and discusses the 

NRC’s responses to these comments. 

Part II discusses comments received on 

the specific sections of the 10 CFR part 

35 amendments in the proposed rule 

and the NRC’s responses to these 

comments. 

Part I Public Comments on the 

Specific Issues on Which the NRC 

Requested Comments 

In the proposed rule, the NRC 

requested comments on the following 

specific issues: 

i. Dose-Volume Specification for 

Determining Absorbed Dose to Normal 

Tissue for MEs Under § 35.3045, Report 

and Notification of an ME 

The NRC asked whether, in defining 

MEs, the proposed volume of 5 

contiguous cubic centimeters dosevolume specification for an absorbed 

dose to normal tissue located both 

outside and within the treatment site is 

appropriate. The NRC also asked 

whether the application of the proposed 

ME definition for normal tissue based 

on the absorbed dose to the maximally 

exposed 5 contiguous cubic centimeters 

during permanent implant 

brachytherapy is appropriate for all 

potential treatment modalities, or 

whether it may result in unintended 

consequences for tissues or organs 

adjacent to the treatment site. 

The NRC received numerous 

comments on this issue. The comment 

summaries and NRC responses to 

comments on this issue are discussed in 

Part II, Comments on Specific Sections 

in the Proposed Rule, under §§ 35.41 

and 35.3045. 

ii. Implementation Period 

The NRC asked whether a 180-day 

effective date for the final rule is 

sufficient to communicate the changes 

to all practitioners and for practitioners 

to revise procedures, train on them, and 

implement the changes. Three 

commenters responded to this question. 

One commenter stated that 180 days is 

sufficient to implement the rule. 

However, two commenters stated that 

365 days or more is needed to 

implement significant changes related to 

the dose evaluation requirements 

proposed for the ME criteria portion of 

the rule. Two commenters also 

recommended that the amendments 

related to PRM–35–20 should be 

implemented immediately, or in no 

more than 30 days. Because the ME 

criteria related to the dose evaluations 

to normal tissues are removed in the 

final rule, the NRC determined that 180 

days is sufficient to implement the final 

rule. 

iii. Impact on Clinical Practice 

The NRC asked if any of the changes 

in the proposed rule are likely to 

discourage licensees from using certain 

therapy options or otherwise adversely 

impact clinical practice, and if so, how. 

The NRC received several comments 

on this issue. The comment summaries 

and NRC responses to comments on this 

issue are discussed in Part II, Comments 

on Specific Sections in the Proposed 

Rule, under §§ 35.390 and 35.396. 

iv. Compatibility Category for the 

Agreement States for § 35.3045, Report 

and Notification of a Medical Event 

Currently § 35.3045, Report and 

notification of a medical event, is 

designated as Compatibility Category C 

for the Agreement States. This 

designation means that the essential 

objectives of the requirement should be 

adopted by the State to avoid conflicts, 

duplications, or gaps. The manner in 

which the essential objectives are 

addressed in the Agreement State 

requirements need not be the same as 

NRC requirements, provided the 

essential objectives are met. Under 

Compatibility Category C, Agreement 

States may require the reporting of MEs 

with more restrictive criteria than those 

required by the NRC if they do not 

create a conflict, duplication or gap with 

the essential objectives of the regulation. 

Some medical licensees have multiple 

locations, some of which are NRCregulated and some of which are 

Agreement State-regulated. Many of 

these licensees would prefer a 

Compatibility Category B designation 

for uniformity of practice and 

procedures among their different 

locations. A Compatibility Category B 

designation is for those program 

elements that apply to activities that 

have direct and significant effects in 

multiple jurisdictions. 

During the development of the 

proposed rule, the OAS expressed a 

strong desire to retain a dose-based ME 

reporting criterion for the treatment site 

if NRC regulations are revised to include 

only activity-based criteria for 

determining MEs for permanent implant 

brachytherapy. The OAS had no 

objection to the introduction of the 

activity-based criteria, as long as the 

dose-based criteria could be retained by 

the Agreement States. With a 

Compatibility Category C designation, 

some Agreement States indicated they 

could require both the dose-based 

criterion and source-strength based 

criterion, as long as the Agreement State 

reports to the NRC using the reporting 

criteria that meets the essential 

objectives of the NRC regulatory 

requirements. As discussed in the 

proposed rule published on July 21, 

2014, for some Agreement States, 

Compatibility Category B is difficult to 

achieve because their regulations must 

also meet specific state requirements 

based on the state agencies in which the 

radiation control regulators reside. Also, 

Agreement States may have existing 

laws requiring the collection of 

additional information on medical 

diagnostic and therapy procedures. 

If the level of compatibility for 

§ 35.3045 were to be raised to 

Compatibility Category B, Agreement 

State requirements would need to be 

essentially identical to those of the NRC. 

Compatibility Category B is applied to 

requirements that have significant direct 

transboundary health and safety 

implications. 

The ACMUI in its report to the NRC 

(Enclosure 4 to SECY–13–0084) 

recommended that MEs related to 

permanent implant brachytherapy be 

designated as Compatibility Category B. 

The ACMUI was concerned with the 

proposed designation as Compatibility 

Category C, which would allow the 

Agreement States to retain the dosebased criteria for an ME for permanent 

implant brachytherapy. The ACMUI 

asserted that a Compatibility Category C 

would continue to result in clinically 

insignificant occurrences being 

identified as MEs by Agreement States 

and thereby perpetuate the confusion 

associated with the current dose-based 

criteria. The ACMUI stated that the most 

important component of the rationale 

for conversion from dose-based to 


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activity-based criteria is the failure of 

dose-based criteria to sensitively and 

only specifically capture clinically 

significant MEs in permanent implant 

brachytherapy. 

The Commission, in the SRM to 

SECY–13–0084, directed the NRC staff 

to designate § 35.3045 as Compatibility 

Category B in the proposed rule, which 

was subsequently published on July 21, 

2014 (79 FR 42410). The NRC 

specifically invited comments on the 

appropriate compatibility category for 

ME reporting under § 35.3045. 

The NRC received 19 comments on 

this issue. The medical community 

submitted ten comments in support of 

Compatibility Category B. The 

Organization of the Agreement States 

(OAS), the Conference of Radiation 

Control Program Directors (CRCPD), and 

7 Agreement States submitted 

comments in support of Compatibility 

Category C. The medical community 

commenters stated that some medical 

licensees practice at multiple locations, 

some of which are NRC-regulated and 

some of which are Agreement Stateregulated. These commenters stated that 

a Compatibility Category B designation 

would allow for uniformity of practice 

and procedures across the country. They 

stated that moving § 35.3045 from 

Compatibility Category C to B is 

appropriate and necessary. The 

commenters from the medical 

community also stated that they 

recognize that the Agreement States 

oppose a change in Compatibility 

Category, citing state legislative 

requirements, the difficulty in changing 

state regulations, and the fact that States 

do not perceive a problem with the 

current dose-based definition. While the 

commenters from the medical 

community appreciate these concerns, 

they believed these concerns are 

outweighed by the importance of having 

a consistent definition throughout the 

country to prevent confusion and 

unnecessary reporting of otherwise 

medically acceptable events. They 

expressed concern that a Compatibility 

C designation would allow Agreement 

States to implement unnecessarily more 

expansive criteria that may classify 

medically acceptable procedures as an 

ME. 

The Agreement States, OAS, and 

CRCPD recommended that the 

compatibility designation for ME 

reporting under § 35.3045 be designated 

as Compatibility C. They argued that 

under Compatibility Category C the 

Agreement States would continue to 

have the flexibility to add additional 

reporting terms (for example, shorter 

timelines for reporting, or a requirement 

to report diagnostic MEs). Several 

Agreement States questioned how a 

single medical incident at a single 

facility can have ‘‘direct and significant 

effects in multiple jurisdictions.’’ They 

further added that the Compatibility 

Category C designation has been 

adequate for the reporting requirements 

for radiography, irradiator, and well 

logging licensees who routinely work in 

multiple jurisdictions. One Agreement 

State stated that the proposed activitybased ME reporting criteria should be 

added to the existing dose-based 

criteria, rather than replace it. The 

Agreement State stated that it would 

require licensees to apply both criteria, 

and only those MEs that meet the NRC’s 

proposed activity-based criteria would 

be reported to the NRC. 

Based on these comments, and review 

of the NRC’s Management Directive 5.9 

‘‘Adequacy and Compatibility of 

Agreement State Programs,’’ NRC staff 

determined that ME reporting under 

§ 35.3045 should be designated as 

Compatibility Category C. Under 

Compatibility Category C, the 

Agreement States must adopt the 

essential objective of the requirement to 

avoid conflicts, duplications, or gaps. 

The essential objective of § 35.3045 is to 

maintain a consistent national program 

for reporting MEs. A consistent national 

program for reporting MEs allows the 

NRC to identify trends or patterns, 

identify generic issues or concerns, 

recognize inadequacies or unreliability 

of specific equipment or procedures, 

and determine why an event occurred 

and whether any actions are necessary 

to improve the effectiveness of NRC and 

Agreement State regulatory programs. 

The NRC has determined that 

allowing Agreement States to use the 

dose-based criteria in addition to the 

activity-based criteria for permanent 

implant brachytherapy MEs in 

§ 35.3045(a)(2) would create 

inconsistencies in the national reporting 

program and disrupt the NRC and 

Agreement States’ ability to use the 

national program for reporting MEs for 

the purposes described above. As a 

result, the use of dose-base criteria 

instead of activity-based criteria would 

create a conflict with the NRC’s 

essential objective of this regulatory 

provision, which could impair the 

effective and orderly regulation of 

agreement material on a nationwide 

basis. 

The NRC staff concluded that the 

continued use of a dose-based criteria 

could: (1) Preclude a practice in the 

national interest to have consistent 

reporting and notification standard; (2) 

impair effective communication; and (3) 

preclude an effective review or 

evaluation by the Commission and 

Agreement State programs for agreement 

material with respect to protection of 

public health and safety. Under 

Compatibility Category C for reporting 

permanent implant brachytherapy ME’s, 

the regulatory provision uses activitybased criteria to ensure the consistent 

reporting of significant events as MEs 

across the country. Agreement States’ 

use of dose-based criteria for these 

reporting requirements would not be 

compatible with this provision because 

it conflicts with the essential objective 

of this provision to maintain a 

consistent national program for 

reporting MEs. 

The NRC staff considered 

Compatibility Category B for the ME 

criteria for permanent implant 

brachytherapy in § 35.3045(a)(2), but 

concluded that this designation is not 

justified, because ME reporting, while 

important to the effective and orderly 

regulation of agreement material on a 

nationwide basis, does not have 

significant direct transboundary 

implications. As a Compatibility 

Category C regulatory provision, the 

Agreement States have the flexibility to 

include, for example, a shorter reporting 

time, but the use of dose-based ME 

reporting criteria for permanent implant 

brachytherapy would create conflicts 

and inconsistencies with respect to the 

national reporting program. Therefore, 

the NRC will not accept, under 

Compatibility Category C, Agreement 

State use of dose-based criteria for 

permanent implant brachytherapy ME 

reporting. 

The comment summaries and NRC 

responses on this issue are discussed in 

Part II of this section, under § 35.3045. 

Part II Comments Received on the 

Specific Sections in the Proposed Rule 

Section 30.34(g) Terms and Conditions 

of Licenses 

Comment: One commenter noted that 

Tc-99m decays much faster than Mo-99, 

therefore, every Tc-99m generator eluate 

will eventually exceed the regulatory 

limit. Because of this, the commenter 

stated that the language in the proposed 

rule text would require every eluate to 

be reported. The commenter proposed 

revising the rule text in § 30.34(g) to 

clarify that the licensee would only 

report measurements of a Tc-99m 

generator elution that exceeded the 

regulatory limits at the time of generator 

elution. 

Response: The rule text was modified 

in response to this comment. The NRC 

agrees with the commenter that the 

proposed rule text was not clear in 

§ 35.204(e) and has amended it to clarify 


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that the reporting requirements only 

apply at the time of generator elution. 

Section 35.2 Definitions 

Issue 1: Definition of an Associate 

Radiation Safety Officer 

Comment: One commenter agreed 

with and supported the new definition 

of an Associate Radiation Safety Officer. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter stated that 

some Agreement States are already 

using the term Assistant Radiation 

Safety Officer and suggested the NRC 

allow the use of a term other than 

‘‘Associate,’’ such as ‘‘Assistant.’’ The 

commenter stated that this change 

would alleviate the workload required 

to modify certain Agreement States’ 

medical licenses. Another commenter 

requested that the terms Assistant and 

Associate be used interchangeably. 

Response: No change was made to the 

rule text based on this comment. To 

establish a clear regulatory requirement, 

the term Associate Radiation Safety 

Officer (ARSO) is retained. Although the 

term Assistant RSO is used in some 

Agreement States, each Agreement State 

may require individuals to meet 

different T&E standards to be named as 

an Assistant RSO on a license. 

Therefore, any individual whom an 

Agreement State has designated as an 

Assistant RSO is not recognized by the 

NRC and may not be recognized by 

other Agreement States. The new 

definition will establish clear and 

concise requirements that an individual 

would need to meet in order to be 

recognized as an Associate RSO by the 

NRC and Agreement States. 

Issue 2: Definition of an Ophthalmic 

Physicist 

Comment: One commenter asserted 

that there was not a sufficient need to 

create an ophthalmic physicist 

designation and that by doing so the 

NRC will set a precedent for other 

source-specific designations, rendering 

the AMP obsolete. 

Response: No change was made to the 

rule text based on this comment. The 

designation of an ophthalmic physicist 

is retained. Authorized Users who work 

in remote areas may not have ready 

access to an AMP to perform the 

necessary calculations and other 

activities outlined in the new § 35.433 

to support the ophthalmic treatments. 

This rule change will make the 

procedure involving the use of Sr-90 

sources for ophthalmic treatments 

available to more patients located in 

remote areas. The NRC does not believe 

the addition of the ophthalmic physicist 

will render the AMP obsolete because 

the primary role of the AMP is to 

support the medical uses under § 35.600 

and certain uses under § 35.1000. The 

proposed revision would not prohibit an 

AMP from assisting the ophthalmic AU. 

Issue 3: Definition of a Preceptor 

Comment: One commenter agreed 

with and supported the new definition 

of a Preceptor. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Section 35.24 Authority and 

Responsibilities for the Radiation 

Protection Program 

Comment: One commenter asserted 

that ARSOs should not be named on a 

medical license but licensees should be 

allowed to name ARSOs in their 

radiation programs. The commenter 

disagreed with the NRC’s argument that 

licensees are having a difficult time in 

naming an RSO due to an RSO not being 

able to sign a preceptor form. Further, 

the commenter stated that ‘‘[t]he NRC 

and Agreement States are authorized to 

approve a proposed licensee’s RSO 

based upon their T&E without the 

preceptor attestation.’’ 

Response: No change was made to the 

rule text based on this comment. The 

NRC maintained the provision to name 

ARSOs on medical licenses to avoid 

confusion between individuals named 

on a license as opposed to individuals 

working in a radiation program and to 

establish regulatory requirements for 

training and experience. This will allow 

the individual who is named as an 

ARSO to be recognized by Agreement 

States and the NRC as an RSO or ARSO 

for the same medical uses on another 

license without resubmitting his or her 

T&E documents. 

The ACMUI identified two issues 

with respect to securing an RSO’s 

signature on a preceptor statement: 

There were not enough preceptors and 

some preceptors were not willing to sign 

preceptor statements. Naming the 

ARSOs on a license and permitting 

them to sign preceptor forms will 

increase the number of individuals who 

may sign the preceptor forms. Changes 

to the attestation language will remove 

impediments for individuals who were 

not willing to sign the previous 

preceptor statements. These changes 

will enhance opportunities for RSO 

candidates. 

The NRC disagrees with the comment 

that RSOs are approved based upon 

their T&E without a preceptor 

statement. Under current regulations, an 

individual seeking to be named as an 

RSO on a medical license must submit 

a preceptor statement. The new 

provision in this rulemaking will only 

remove the preceptor attestation 

requirements for individuals who are 

certified by a board recognized by the 

NRC or Agreement States. Individuals 

seeking to be named as an RSO or ARSO 

under the alternate pathway will need 

to submit a preceptor statement. 

Comment: One commenter 

recommended revising the rule text in 

§ 35.24(b) to read, ‘‘These duties and 

tasks are restricted to the types of use 

for which the Associate Radiation Safety 

Officer is listed on the license as an AU, 

AMP or ANP, or has training in the 

radiation safety, regulatory issues and 

emergency procedures.’’ The commenter 

believed that this revision ‘‘would align 

it with 30.50(d).’’ 

Response: The NRC assumes the 

commenter intended to reference 

proposed § 35.50(d) not § 30.50(d). The 

ARSO must be listed on a license before 

being assigned duties and tasks as an 

ARSO. The individual may be assigned 

tasks outside of the agreed upon list of 

ARSO duties and tasks in order to 

obtain additional T&E. 

The commenter’s proposed text 

would imply that the ARSO is listed on 

a license as an AU, AMP, or ANP. This 

is not always the case. Further, as 

written in the proposed rule and in the 

rule text suggested by the commenter, 

the regulations could have permitted the 

RSO to assign duties and tasks to the 

individual as the ARSO for which he or 

she was not fully qualified (i.e., assigned 

duties and tasks for a type of use for 

which he or she was not listed on the 

license). Therefore, for clarification, the 

NRC has revised the rule text in 

§ 35.24(b) to read, ‘‘These duties and 

tasks are restricted to the types of use 

for which the Associate Radiation Safety 

Officer is listed on the license.’’ 

Comment: Two commenters 

expressed concern that there is no clear 

guidance or a policy on the number of 

licenses on which an individual could 

be named as an RSO or an ARSO. One 

commenter requested that the NRC 

develop this policy or guidance. The 

other commenter recommended that the 

NRC, Agreement States, ACMUI, and 

the medical community work together 

to develop guidance or a policy that can 

be consistently applied across all 

regulatory jurisdictions to establish the 

minimum amount of time an RSO or an 

ARSO listed on multiple licenses would 

be required to spend at each licensed 

facility. 

Response: No change was made to the 

rule text based on these comments. 

Current NRC regulations do not limit 

the number of licenses on which an 


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RSO can be listed concurrently. Some 

Agreement States limit the number of 

licenses on which an individual may be 

named as the RSO. The NRC regulations 

do not impose any such limit. Rather, 

the NRC evaluates, on a case-by-case 

basis, whether the proposed RSO would 

have sufficient involvement in the 

program and if necessary, limits the 

number of licenses on which that RSO 

is named. 

Section 35.40 Written Directives 

Comment: One commenter questioned 

the phrase in § 35.40 (b)(6)(i): ‘‘. . . if 

appropriate, the expected absorbed 

doses to normal tissues located within 

the treatment site,’’ and stated that the 

term ‘‘appropriate’’ is very subjective. 

The commenter also asked who decides 

if normal tissues are located within the 

treatment site and if this is a clinical 

decision. The commenter was 

concerned that an inspector might 

determine appropriateness differently 

than the licensee’s AU or AMP, 

resulting in a potential violation based 

on a difference in interpretation. The 

commenter believes that the WD should 

not include expected doses to normal 

tissues located within the treatment site 

because there may be clinical reasons 

for an AU to accept a higher dose to a 

normal structure in close proximity to 

involved tissues. 

Response: The rule text was modified 

based on this and other comments. The 

NRC agrees that, for permanent implant 

brachytherapy, the determination of the 

appropriate dose to normal tissue (if 

any) located within the treatment site is 

a matter of medical judgment. The NRC 

has removed the reference to dose to 

normal tissue located within the 

treatment site. The rule text in 

§ 35.40(b)(6)(i) was modified to remove 

the requirement to include in the preimplantation WD the language ‘‘if 

appropriate, the expected doses to 

normal tissues located within the 

treatment site.’’ 

Comment: One commenter stated that 

the wording of § 35.40(b)(6) refers to 

‘‘permanent implant brachytherapy,’’ 

but the remainder of the rule reads as if 

it was written for brachytherapy seeds. 

The commenter noted that Y-90 

microspheres are sealed brachytherapy 

sources that are permanently implanted. 

The commenter asked if the new rule 

may be used in place of the existing 

guidance for Y-90 microsphere use 

under § 35.1000. 

Response: No change was made to the 

rule text based on this comment. The 

term ‘‘permanent implant 

brachytherapy’’ is used to refer to 

manual brachytherapy procedures 

performed in accordance with § 35.400. 

The NRC considers Y-90 microspheres 

to be manual brachytherapy sources; 

however, they have unique properties 

that prevent them from being regulated 

under all the provisions of § 35.400. 

Therefore, they are regulated under 

§ 35.1000. Consequently, the new rule 

does not apply to the use of Y-90 

microspheres. 

Comment: One commenter supported 

specification of a ‘‘before implantation’’ 

and an ‘‘after implantation’’ assessment 

as an excellent improvement from the 

current regulations. However, the 

commenter stated that defining the 

‘‘treatment site’’ is a concern for prostate 

procedures. The commenter noted that 

an AU may need to change the 

definition of the treatment site and 

intended doses to critical structures 

based on intraoperative imaging results. 

This could result in the evaluation for 

an ME for absorbed dose to normal 

tissue to be based on a condition that 

changed during the implant procedure. 

Response: The rule text was modified 

in response to this comment. The rule 

text in § 35.40(b)(6)(ii) was changed to 

allow the AU to change the description 

of the treatment site in the postimplantation WD. The NRC agrees that 

an AU needs flexibility to change the 

definition of the treatment site based on 

the condition of the patient and imaging 

results obtained during the implant 

procedure. Further, based on other 

comments, the NRC removed the 

requirements to include, in the WD, the 

absorbed dose to normal tissue in 

§ 35.40(b)(6)(i). 

Comment: One commenter stated that 

the after implantation WD requirement 

in § 35.40(b)(6)(ii) is consistent with 

clinically relevant circumstances. 

However, the commenter believes that it 

would be appropriate to list the number 

of seeds purposely implanted outside 

‘‘the prostate plus margin specified in 

the prescription,’’ because this 

information will be needed when 

determining an ME. 

Response: No change was made to the 

rule text based on this comment. The 

AU defines the treatment site in the WD 

in the way he or she believes to be 

medically appropriate, including any 

margin. The AU may define the 

treatment site to include all tissues into 

which sources have been purposely 

implanted. 

Comment: Two commenters 

supported the requirement in 

§ 35.40(b)(6) for a two-part WD for 

permanent implant brachytherapy, with 

one part before implantation and a 

second part after implantation. One 

commenter stated that ‘‘documentation 

of the number of sources and total 

source strength is easily determined 

within 24 hours after implant 

completion.’’ 

Response: The comment supports 

language in the rule; therefore, no 

response is required. However, the NRC 

notes that the post-treatment WD has to 

be completed before the patient leaves 

the post-treatment recovery area. 

Comment: Two commenters 

supported the proposal to allow 

modification of the WD based on the 

medical situation encountered by the 

physician during the permanent implant 

brachytherapy procedure. One of the 

commenters noted that when 

modifications to the WD are medically 

necessary, these modifications should 

not constitute an ME. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Section 35.41 Procedures for 

Administrations Requiring a Written 

Directive 

Comment: One commenter stated that 

the method and timing of the 

comparison in § 35.41(b)(6)(i) is unclear. 

The commenter noted that there is no 

requirement to include in the postimplantation WD the number of sources 

implanted outside the treatment site. 

The commenter believes that comparing 

the total source strength implanted 

outside of the treatment site with the 

total source strength implanted inside 

the treatment site is unreasonable 

because some sources may intentionally 

be implanted outside the treatment site 

as defined in the pre-implantation WD. 

The commenter suggested rewriting this 

section to clearly specify that the 

concern is errors in source placement, 

not sources outside the treatment site. 

Response: No change was made to the 

rule text based on this comment. 

Section 35.41(b)(6)(i) requires a licensee 

to determine, within 60 days from the 

date the permanent brachytherapy 

implant was performed, the total source 

strength administered outside of the 

treatment site compared to the total 

source strength documented in the postimplantation portion of the WD. The AU 

defines the treatment site (as defined in 

§ 35.2) in the WD in any way he or she 

believes to be medically appropriate. 

The AU may define the treatment site to 

include all tissues into which sources 

will be purposely implanted. Therefore, 

the total source strength implanted in 

unintended locations would be 

compared with the total source strength 

documented in the post-implantation 

portion of the WD. 

Comment: One commenter stated that 

it appears reasonable in theory to 

determine absorbed dose to the 

maximally exposed 5 contiguous cubic 


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centimeters of normal tissue. However, 

the commenter believes that it will be 

difficult to make this determination 

using current technology. The 

commenter stated that ‘‘planning 

systems typically report dose-volume 

histograms to structures, but they do not 

identify contiguous volumes.’’ 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.41(b)(6) was modified to remove 

§ 35.41(b)(6)(ii) and (iii). The NRC 

acknowledges that while some 

treatment planning systems can identify 

contiguous volumes, others cannot. In 

response to this concern and concerns 

raised by other commenters, the NRC 

removed subparagraphs (ii) and (iii), 

which would have required the licensee 

to determine the absorbed dose to 

normal tissues located both outside and 

within the treatment site. 

Comment: One commenter 

recommended modifying § 35.41(a) by 

adding: ‘‘(3) After administration, an ME 

as defined in § 35.3045 has not occurred 

. . .’’ 

Response: No change was made to the 

rule text based on this comment. The 

NRC determined that the recommended 

rule change is not necessary because 

§ 35.41(b)(5) requires that at a 

minimum, the procedures required by 

§ 35.41(a) include ‘‘[d]etermining if a 

medical event, as defined in § 35.3045, 

has occurred.’’ 

Comment: Several commenters noted 

that the proposed regulation would 

apply to all permanent brachytherapy 

implants, including lung mesh 

procedures. They stated that licensees 

do not routinely perform dose 

assessments because the mesh is 

visually sewn to the lung in the 

prescribed location and the sources are 

not vulnerable to migration. The 

commenters recommended excluding 

lung mesh treatments from the 

requirements of § 35.41(b)(6). 

Response: The rule text was modified 

based on this and other comments. The 

NRC recognizes the difficulty in 

determining the absorbed dose to 

normal tissues for treatments that use 

mesh material with permanent 

brachytherapy sources incorporated into 

the mesh. In response to this concern 

and those raised by other commenters, 

the NRC removed subparagraphs (ii) and 

(iii) in § 35.41(b)(6), which would have 

required the licensee to determine the 

absorbed dose to normal tissues located 

both outside and within the treatment 

site. The NRC retained § 35.41(b)(6)(i) to 

determine the total source strength 

administered outside of the treatment 

site compared to the total source 

strength documented in the postimplantation WD for all permanent 

brachytherapy, including mesh 

procedures. The NRC retained this 

requirement because it is important to 

ensure that the use of the radionuclide 

is in accordance with the WD. 

Comment: Several commenters stated 

that they support the requirement for 

performing a post-implant dosimetric 

evaluation of each permanent 

brachytherapy implant within 60 days. 

However, there may be other obstacles 

to meeting this 60-day requirement, 

beyond patient unavailability, that 

should be added to the rule text. For 

example, one commenter noted that a 

machine may be broken and the facility 

may not have a backup, or the facility 

may have lost electricity because of a 

storm. The commenters suggested 

modifying the language in § 35.41(b)(6) 

to also allow written justification related 

to other factors ‘‘outside the control’’ of 

the licensee. 

Response: No change was made to the 

rule text based on these comments. A 

60-calendar-day time frame ensures that 

the licensee has ample time to make 

arrangements for the required 

determination in § 35.41(b)(6). If the 

licensee’s imaging device malfunctioned 

or the facility lost electricity, it should 

be possible to refer the patient to 

another facility for the imaging study 

within the 60-day time frame. Further, 

in response to other comments, NRC reevaluated the requirements for postimplant dosimetric evaluation to the 

normal tissue and has removed this 

requirement. 

Comment: One commenter believes 

that the assessment of permanent 

brachytherapy implants described in 

§ 35.41(b)(6) should be part of the 

medical evaluation of the treatment and 

not part of the procedures to provide 

high confidence that the administration 

is in accordance with the WD. The 

commenter also noted the difficulty in 

meeting this requirement, if it is 

retained, for permanent implants of 

certain large tumors. In these cases, a 

surgical procedure to remove part of the 

tumor may be performed shortly after 

the implant and this may result in 

intentional removal of many of the 

seeds. Post-implant removal of sources 

will change the dose to normal tissues. 

The commenter stated that the proposed 

regulation appears to require re-imaging 

to localize the remaining sources to 

perform the required assessment; 

however, it is unlikely that this 

additional assessment was intended. 

Response: The rule text was modified 

in response to other comments. The 

NRC modified the rule text in 

§ 35.41(b)(6) to remove the requirement 

to determine the absorbed dose to 

normal tissues located outside the 

treatment site and within the treatment 

site. The NRC retained the requirement 

to determine the total source strength 

administered outside of the treatment 

site compared to the total source 

strength documented in the postimplantation WD. It is likely that most 

licensees will perform the 

determination of total source strength 

administered outside of the treatment 

site by performing an imaging study 

such as a computed tomography scan. If 

it is necessary to remove part of the 

tumor shortly after the implant, this 

imaging study may be performed before 

the tumor removal. 

Section 35.50 Training for Radiation 

Safety Officer and Associate Radiation 

Safety Officer 

Comment: One commenter agreed 

with the changes in the T&E 

requirements for AUs, medical 

physicists, RSOs, and nuclear 

pharmacists. The commenter also 

supported the establishment of the 

ARSO because they believe it provides 

a pathway for more individuals to be 

RSOs and increases the number of 

preceptors available for future RSOs and 

ARSOs. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter supported 

the inclusion of an ANP in the pathway 

to be identified as an ARSO on a 

medical license. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: Several commenters 

supported the removal of the preceptor 

statement requirement for individuals 

who are certified by a specialty board 

whose certification process has been 

recognized by the NRC or an Agreement 

State and are applying to be named as 

an RSO, ARSO, ANP, AMP, or AU. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter supported 

ARSOs being named on licenses and 

being able to serve as preceptors. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter stated that 

the ARSO position created in the 

proposed rule does not create a new 

pathway for an individual to become an 

RSO. The commenter proposed that the 

NRC create a new pathway for an 

individual to qualify as an RSO by 

relaxing the T&E requirements for an 

ARSO. This new pathway would require 

an individual to meet only the 

education requirements in § 35.50 to be 


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named as an ARSO and then participate 

in a year-long training program. The 

commenter’s expectation was that, at 

the end of the year-long training 

program, the ARSO would have gained 

proficiency in each of the areas listed in 

the regulations and could work 

independently and be qualified to be an 

RSO. The commenter also proposed that 

management would have the ARSO 

agree in writing to be responsible for 

implementing the radiation protection 

program. 

Response: No change was made to the 

rule text based on this comment. The 

ARSO position created in the proposed 

rule does create a new pathway for an 

individual to become an RSO. An ARSO 

can become an RSO for the same types 

of use of byproduct material for which 

he or she was assigned duties and tasks 

as an ARSO on a medical license. This 

new pathway requires the same T&E for 

ARSOs as the current regulations for 

individuals seeking to be an RSO. 

The commenter proposed adding a 

pathway for an individual to qualify as 

an RSO via the ARSO position. This 

proposed pathway is problematic 

because it would create a training 

program for an individual to become an 

ARSO without the individual meeting 

all the required T&E for an ARSO or an 

RSO. The NRC does not intend for this 

rule to create a training program for an 

individual to become an ARSO who is 

not fully qualified to be an RSO. The 

NRC did not include a provision to 

require management to have the ARSO 

agree in writing to be responsible for 

implementing the radiation safety 

program because the RSO is responsible 

for the radiation safety program. The 

RSO may delegate tasks and duties to 

the ARSO but the final rule at § 35.24(b) 

states that the RSO ‘‘shall not delegate 

the authority or responsibilities for 

implementing the radiation protection 

program.’’ 

Comment: Two commenters 

recommended relaxing the 

qualifications for the ARSO to allow onthe-job training while serving in an 

assistant or associate position. 

Response: No change was made to the 

rule text based on these comments. The 

commenters’ proposal would have 

resulted in recognition of an individual 

as an ARSO when the individual had 

not satisfactorily completed all the 

training and experience qualifications to 

perform his or her duties and tasks and 

could be recognized as an RSO at a later 

date. An ARSO may receive additional 

on-the-job training to expand his or her 

training and skills to apply for ARSO 

status for additional types of use. 

Comment: One commenter asserted 

that the changes to the regulations 

would permit AUs to be RSOs. Doing so, 

according to the commenter, would 

weaken the position held by the RSO 

because a physician AU acting as the 

RSO is doing so as an additional duty. 

The commenter asserted that these 

RSOs were neither familiar with the 

regulations nor the recordkeeping 

requirements of a radiation safety 

program. The commenter further stated 

that if they made a mistake as an AU, 

it was often overlooked or corrected by 

simply re-writing a prescription for a 

particular treatment. 

Response: No change was made to the 

rule text based on this comment. 

Current regulations recognize an AU as 

being qualified to be an RSO consistent 

with the AU’s authorization and 

required radiation safety experience. 

This provision was unchanged in this 

rulemaking. The NRC expects that all 

AUs/RSOs take their responsibilities 

and obligations seriously and notes that 

AUs/RSOs should not overlook or 

‘‘correct’’ errors by ‘‘simply re-writing a 

prescription for a particular treatment.’’ 

Comment: Several commenters 

opposed having an ARSO provide a 

preceptor attestation for an individual 

seeking to be named as an RSO. The 

commenters stated that an ARSO is only 

responsible for certain duties or limited 

sections of the program while the RSO 

is responsible for the entire radiation 

safety program. One commenter further 

recommended that an ARSO should 

only be permitted to provide a preceptor 

statement for an individual seeking to 

be named as an ARSO. 

Response: No change was made to the 

rule text based on these comments. For 

each medical use for which an ARSO is 

authorized, the T&E requirements are 

the same as that of an RSO. Further, the 

requirements for the preceptor are the 

same, regardless of whether they are an 

RSO or an ARSO. Therefore, an ARSO 

can be a preceptor for a potential RSO 

or a potential ARSO, but only for those 

uses for which the preceptor ARSO is 

authorized. 

Comment: Two commenters 

recommended that AUs, ANPs, or AMPs 

be allowed to serve as RSOs on 

individual licenses for private practices 

(i.e., non-hospital sites). 

Response: No change was made to the 

rule text based on these comments. The 

current regulations already allow AUs, 

AMPs, and ANPs to serve as RSOs on 

private practice licenses and other nonhospital medical facilities. 

Comment: One commenter requested 

that the rule text in § 35.50(c)(1), (2), 

and (3) be consistent with respect to the 

description of the radiation safety 

experience and types of use to avoid 

confusion. The commenter pointed out 

that the text in paragraphs (c)(1) and (2) 

included ‘‘similar types of use’’ whereas 

paragraph (c)(3) implies the exact same 

types of use. 

Response: The rule text was modified 

based on this comment. The NRC agrees 

with the commenter that there should 

be consistency between the rule text in 

§ 35.50 (c)(1) and (2). The rule text in 

paragraphs (c)(1) and (2) was changed to 

read ‘‘has experience with the radiation 

safety aspects of similar types of use of 

byproduct material for which the 

licensee seeks the approval of the 

individual as the Radiation Safety 

Officer or Associate Radiation Safety 

Officer.’’ However, a similar change was 

not made to the rule text in § 35.50(c)(3). 

The provisions in § 35.50(c)(3) only 

address a new license application where 

the applicant is requesting that a 

qualified individual, who has not 

previously been named on a license, be 

named as both an AU and the RSO on 

the new license. The new license will 

authorize only those types of uses for 

which the proposed AU/RSO has T&E. 

Comment: One commenter sought 

clarification on whether § 35.50(c)(3) 

applied to a new license with just one 

potential AU. The commenter believes 

that license reviewers would use 

paragraph (c)(3), as written in the 

proposed rule, to add the first AU/RSO 

and then process a separate licensing 

action to add other AUs. 

Response: The rule text was modified 

based on this comment. The NRC’s 

intent in the proposed rule was for the 

provision in § 35.50(c)(3) to apply to a 

single physician applicant who was not 

yet authorized to be an AU and has 

requested to be both the AU and RSO. 

Based on the comment, the NRC has 

broadened the provision in § 35.50(c)(3) 

to include an applicant for a new 

medical use license with multiple AUs 

who requests an individual, qualified 

but not yet recognized to be an AU, to 

be both an AU and the RSO on the new 

license. 

Comment: One commenter asserted 

that the provisions in § 35.50(c)(2) were 

all that were needed in a rural setting to 

appoint an individual as both an AU 

and an RSO simultaneously, and 

§ 35.50(c)(3) was not needed, unless 

§ 35.50(c)(3) individuals are not subject 

to the requirements in § 35.50(d). 

Response: The rule text was modified 

based on this comment. For clarity, the 

rule text was revised to add a reference 

to § 35.50(d) in § 35.50(c)(3) based on 

both this and another comment. The 

provisions in § 35.50(c)(3) are distinctly 

different from the provisions of 

§ 35.50(c)(2) and both can be used in 

rural areas. Section 35.50(c)(3) 

addresses only a new license where the 


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physician whom the applicant is 

requesting to be named as an RSO has 

not yet been listed on a license as an 

AU. Section 35.50(c)(2) applies to a new 

application or amendment to an existing 

license where the applicant or licensee 

is requesting to identify an individual 

already identified as an AU, AMP, or 

ANP on a license or permit as the RSO. 

The individuals who meet the 

requirements in § 35.50(c)(2) or (c)(3) 

must also meet the requirements in 

paragraph (d) of this section. 

Comment: One commenter stated that 

the provisions in § 35.50 in the 

proposed rule could be interpreted two 

ways. Due to the word ‘‘and’’ between 

§ 35.50(c)(3) and § 35.50(d), the 

provision in § 35.50(d) could be 

interpreted to apply to § 35.50(c)(3). 

Alternatively, the provision in 

§ 35.50(d) could be interpreted not to 

apply to § 35.50(c)(3). The commenter 

stated that a revision is necessary to 

clarify whether or not paragraph (d) 

applies to (c)(3). The commenter also 

stated that if paragraph (d) does not 

apply to § 35.50(c)(3), this pathway 

would permit a large institution 

applying for a new license to have an 

RSO that did not demonstrate 

compliance with § 35.50(d). 

Response: The rule text was revised 

based on this comment. The rule text 

was revised to add a reference to 

§ 35.50(d) in § 35.50(c)(3). The NRC 

agrees that § 35.50(d) applies to 

§ 35.50(c)(3). Although the NRC 

intended to provide a pathway for a 

single practice physician, if a medical 

institution wants to apply for a Part 35 

medical use license by adding a 

physician (who is qualified but not yet 

authorized as an AU) to be both an AU 

and the RSO, then the institution could 

also use the provisions of § 35.50(c)(3) 

to obtain a medical use license. Note 

that once a hospital has obtained a 

medical use license, the provisions of 

§ 35.50(c)(3) no longer apply because 

they only apply to new licenses. 

Comment: One commenter stated that 

the rule text in § 35.50(c)(3) appeared to 

be ‘‘backward’’ and suggested that the 

paragraph should read ‘‘Is an individual 

who is seeking simultaneous approval 

both as the Radiation Safety Officer and 

the AU on the same new Commission or 

Agreement State license and who has 

experience with the radiation safety 

aspects of the types of use of byproduct 

material for which the individual has 

Radiation Safety Officer 

responsibilities.’’ 

Response: No change was made to the 

rule text based on this comment. 

Starting the paragraph with ‘‘Is an 

individual who . . .’’ would result in 

redundant language because § 35.50 

reads ‘‘Except as provided in 35.57, the 

licensee shall require an individual . . . 

to be an individual who—. . . (c)(3).’’ 

Additionally, because the individual 

has not yet been identified as an AU or 

RSO, the individual does not yet have 

the responsibilities of an RSO. 

Comment: One commenter stated that 

the ARSOs should be fully trained to 

manage the radiation safety program 

issues for all modalities authorized on 

the license. This would simplify the 

license in that specialty areas of use 

would not have to be listed and 

amendments would not be needed for 

changes to ARSO specialty areas. The 

ARSO would be ready to replace the 

RSO with only the delegation of 

authority letter from management 

needed to qualify the ARSO as RSO. 

Response: No change was made to the 

rule text based on this comment. 

Limiting the ARSO designation to only 

those individuals that have T&E in all 

the medical types and uses on the 

license would not permit individuals 

with T&E for some of the medical types 

of use on the license to be recognized 

as ARSOs. The NRC disagrees with the 

commenter’s assertion that the 

individuals should be trained for all 

modalities so that they could be ready 

to replace the RSO. A trained individual 

is not necessarily qualified to be the 

RSO; the individual would also need to 

meet the experience requirements. 

Additionally, the NRC disagrees with 

the commenter’s assertion that only a 

delegation of authority letter is needed 

for the ARSO to become an RSO. Only 

a regulator can name an individual as 

the RSO on a license. 

Comment: One commenter agreed 

with the proposed addition of ARSOs 

but requested a requirement that the 

ARSO’s performance and level of 

activity be reviewed on an annual basis 

by the licensee’s RSO or Radiation 

Safety Committee. The commenter 

believed this would ensure that only the 

active ARSOs with recent experience 

are listed on the license. 

Response: No change was made to the 

rule text based on this comment. The 

requirement in § 35.14(b) for a licensee 

to notify NRC no later than 30 days after 

an ARSO permanently discontinues 

performance of duties as an ARSO is 

adequate without adding a prescriptive 

requirement to annually review the 

performance of the ARSO. 

Comment: One commenter believed 

the T&E of the ARSO should be 

designated as Compatibility Category 

‘‘C.’’ This would give the state program 

the flexibility to more effectively 

monitor the roll out of this new 

provision without adversely affecting 

either the individuals seeking ARSO 

listing/approval or the licensees. 

Response: No change was made to the 

Compatibility Category for the ARSO 

training and experience requirements. 

The NRC has determined that § 35.50 is 

a Compatibility Category B because T&E 

requirements have ‘‘significant direct 

transboundary implications.’’ Assistant 

RSOs might not meet the requirements 

to be an ARSO. Therefore, they may not 

be automatically listed as an ARSO on 

a license. Individuals named as assistant 

RSOs on a state license may continue to 

work as an assistant RSO on that 

license, but will be required to meet the 

requirements in §§ 35.50 and 35.51 if 

they would like to be named as an 

ARSO. 

Comment: Two commenters 

supported the establishment of an 

ARSO, but the commenters believed the 

NRC overemphasized the need to 

provide more preceptors. The 

commenters stated that the more 

important reason for establishing an 

ARSO is to recognize more qualified 

individuals and increase the pool of 

RSOs. One of the commenters further 

stated that many states have had ARSOs 

or similar individuals or multiple RSOs 

on a license for many years and this has 

not caused problems. 

Response: No change was made to the 

rule text based on these comments. The 

NRC recognizes that the increase in the 

number of individuals meeting the 

qualifications in § 35.50 and being 

recognized as ARSOs both increases the 

number of individuals recognized as 

meeting the qualifications for being 

RSOs and the number of available 

preceptors. The NRC continues to 

require under § 35.24(b) that only one 

RSO be listed on each medical use 

license because that is the individual 

responsible for the day-to-day oversight 

of the entire radiation safety program. 

Section 35.55 Training for an 

Authorized Nuclear Pharmacist 

Comment: One commenter asserted 

that specialized residencies in 

pharmacy practice are available and 

more are emerging, including nuclear 

pharmacy practice residency programs. 

The commenter provided a website for 

the American Society of Health-System 

Pharmacists residency directory, which 

contains an online directory of 

pharmacy residency programs, in 

support of this assertion. The 

commenter recommended amending 

§ 35.55(b)(2) to read: 

Has obtained written attestation that the 

individual has satisfactorily completed the 

requirements in paragraph (b)(1) of this 

section and is able to independently fulfill 

the radiation safety-related duties as an 


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authorized nuclear pharmacist. The 

attestation must be obtained from either: (i) 

A preceptor authorized nuclear pharmacist 

who meets the requirements in §§ 35.57 or 

35.55, or equivalent Agreement State 

requirements; or (ii) A residency program 

director who affirms in writing that the 

attestation represents the consensus of the 

residency program faculty where at least one 

faculty member is an authorized nuclear 

pharmacist who meets the requirements in 

§§ 35.57 or 35.55 or equivalent Agreement 

State requirements and concurs with the 

attestation provided by the residency 

program director. The residency training 

program must be approved by the 

Commission on Credentialing of the 

American Society of Health-System 

Pharmacists and must include training and 

experience specified in § 35.55(b)(1). 

The recommended amendment would 

add provisions that would allow the 

residency program director to provide 

an attestation to the T&E requirements 

for an ANP similar to those provisions 

added for an AU, AMP, and RSO. 

Response: No change was made to the 

rule text based on this comment. The 

NRC reviewed the American Society of 

Health-System Pharmacists residency 

directory at the provided website. The 

residency directory included residency 

programs in the United States and two 

foreign countries. The website lists only 

one nuclear pharmacy residency 

program in the United States. Other 

residency programs included in Part 35 

have been accredited by either the 

Residency Review Committee of the 

Accreditation Council for Graduate 

Medical Education, the Royal College of 

Physicians and Surgeons of Canada, or 

the Council on Postdoctoral Training of 

the American Osteopathic Association. 

The Commission on Credentialing of the 

American Society of Health-System 

Pharmacists has not been evaluated by 

the NRC to determine if this 

accreditation group is equivalent to the 

accreditation groups listed above, and to 

do so would be beyond the scope of this 

rulemaking. Therefore, the nuclear 

pharmacy residency program has not 

been included in this rulemaking. The 

commenter may submit its 

recommendation to the NRC as a 

petition for rulemaking under § 2.802. 

Comment: One commenter 

recommended that the NRC recognize 

structured nuclear pharmacy training 

programs, sometimes referred to as 

certificate programs, by amending 

§ 35.55(b)(2) to provide: 

(iii) A program director of a structured 

nuclear pharmacy training program who 

affirms in in [sic] writing that the attestation 

represents the consensus of the training 

program faculty where at least one faculty 

member is an authorized nuclear pharmacist 

who meets the requirements in §§ 35.57 or 

35.55, or equivalent Agreement State 

requirements and concurs with the 

attestation provided by the program director. 

The nuclear pharmacy training program must 

be part of a College or School of Pharmacy 

that is accredited by the Accreditation 

Council for Pharmacy Education. 

This recommended amendment would 

permit program directors of these 

programs to sign the preceptor 

statement when certain conditions, 

similar to the medical residency criteria, 

are met. The commenter also stated that 

the nuclear pharmacy training program 

must be part of a College or School of 

Pharmacy and accredited by the 

Accreditation Council of Pharmacy 

Education. 

Response: No change was made to the 

rule text based on this comment. The 

regulations permit a pharmacist to be 

recognized as an ANP as long as the 

§ 35.55 T&E requirements are met. 

Therefore, if the pharmacist receives his 

or her training from a nuclear pharmacy 

training program in a college or school 

of pharmacy that meets this criterion, 

the pharmacist can be recognized as an 

ANP. The NRC has not had an 

opportunity to evaluate the 

Accreditation Council of Pharmacy 

Education’s nuclear pharmacy 

educational programs, and to do so 

would be beyond the scope of this 

rulemaking. The commenter may submit 

its recommendation to the NRC as a 

petition for rulemaking under § 2.802. 

Section 35.57 Training for 

Experienced Radiation Safety Officer, 

Teletherapy or Medical Physicist, 

Authorized Medical Physicist, 

Authorized User, Nuclear Pharmacist, 

and Authorized Nuclear Pharmacist 

Comment: Several commenters 

supported the revision of § 35.57 to 

recognize individuals certified by the 

boards named in the previous Subpart J 

of 10 CFR part 35 for the modalities that 

they practiced on or before October 24, 

2005. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter requested 

clarification on the type and extent of 

documentation an individual will need 

to produce to demonstrate that he or she 

was practicing certain modalities prior 

to 2005 in order to meet the 

requirements in § 35.57. 

Response: No change was made to the 

rule text based on this comment. The 

NRC provides T&E guidance in NUREG– 

1556, Vol. 9 ‘‘Consolidated Guidance 

about Materials Licenses: ProgramSpecific Guidance about Medical Use 

Licensees.’’ This NUREG provides 

information for meeting the 

requirements in § 35.57. Because each 

situation is unique, the applicant’s 

submitted documentation will need to 

be evaluated on a case-by-case basis. 

Comment: One commenter stated that 

the proposed additional dosage category 

at § 35.390(b)(1)(ii)(G)(4) for the medical 

use of alpha-emitting radionuclides 

such as Radium-223 dichloride would 

result in an unintended consequence. 

Specifically, an AU currently authorized 

to use Radium-223 dichloride would be 

required to have additional work 

experience to be authorized for 

parenteral use of radiopharmaceuticals 

used primarily for their alpha-emitting 

characteristics under 

§ 35.390(b)(1)(ii)(G)(4). The commenter 

requested that, if the NRC retained the 

additional proposed dosage category, 

that the NRC amend the date in 

§ 35.57(b)(1) and (2) from October 24, 

2005, to December 31, 2014, or a later 

date, to grandfather such individuals. 

Response: The rule text was modified 

based on a recommendation from the 

ACMUI. The effective date of the 

grandfathering provisions in the rule 

text in § 35.57(b)(1) is changed from 

October 24, 2005, to the effective date of 

the rule. The commenter is correct that, 

as proposed, the rule text would not 

permit an AU currently administering 

Radium-223 dichloride to be authorized 

to use it after the effective date of the 

rule, and that was not the intent of the 

NRC. The final rule grandfathers all AUs 

authorized for medical uses, including 

Radium-223 dichloride, on the effective 

date of the rule to continue to be able 

to administer it after the rule becomes 

effective without needing to reapply for 

authorization under the new 

requirements in §§ 35.390 or 35.396. 

However, no change was made to the 

rule text in § 35.57(b)(2) because this 

section pertains only to those 

individuals certified by boards 

recognized in Subpart J. 

Note that § 35.390(b)(1)(ii)(G)(4) was 

deleted and provisions within that 

section have been incorporated within 

§ 35.390(b)(1)(ii)(G)(3) based on other 

comments. Therefore, the category 

‘‘parenteral administration of any 

radioactive drug that contains a 

radionuclide that is primarily used for 

its alpha radiation characteristics, for 

which a written directive is required’’ is 

now included in § 35.390(b)(1)(ii)(G)(3). 

After reviewing the ACMUI final 

recommendations on the revised part 35 

rule, the NRC has determined that an 

additional three cases of administering 

dosages of radioactive drugs for alphaemitting radiopharmaceuticals for 

parenteral administration is not 

necessary. 

Comment: Two commenters support 

the concept of grandfathering the RSO, 


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medical physicist, teletherapy physicist, 

AMP, AU, nuclear pharmacist, and 

ANP. However, the commenters stated 

that the date of certification does not 

have an impact on an individual’s 

qualifications to perform the duties of 

an RSO and they do not agree with 

limiting the grandfathering provisions to 

‘‘those materials and uses that these 

individuals performed on or before 

October 24, 2005.’’ The commenters 

believe the continuing education 

requirements for periodic certification 

renewal assures that the individual 

remains qualified. Thus, all board 

certified individuals, regardless of the 

date of their initial certification, are 

equally qualified to be named as an RSO 

or ARSO and that the initial 

certification date is immaterial to one’s 

present technical expertise. 

Response: No change was made to the 

rule text based on these comments. The 

board certification pathway includes not 

only the requirement to be certified but 

also that the individual has training in 

the radiation safety, regulatory issues, 

and emergency procedures for the types 

of use for which the licensee seeks 

approval. That is why the 

grandfathering provisions for the RSO 

include the phrase ‘‘those materials and 

uses that these individuals performed 

on or before October 24, 2005.’’ The 

NRC retained the date of October 24, 

2005, because that was the expiration 

date of the prior T&E requirements 

(Subpart J). 

Comment: Several commenters 

supported the grandfathering of boardcertified individuals but requested the 

rule text be changed from ‘‘for the 

modalities that they practiced on or 

before October 24, 2005,’’ to the 

ACMUI-recommended language ‘‘for the 

uses [or procedures] covered by their 

board certification on October 24, 

2005.’’ These commenters stated that 

the ACMUI language would eliminate 

any potential uncertainty concerning 

what the term ‘‘practiced’’ means. 

Response: No change was made to the 

rule text based on these comments. In 

the Ritenour Petition, the petitioner 

requested that the NRC grandfather 

individuals certified by boards listed in 

Subpart J for the modalities that they 

practiced as of October 24, 2005. 

Further, the board certification pathway 

includes not only the requirement to be 

certified but also that the individual has 

training in the radiation safety, 

regulatory issues, and emergency 

procedures for the types of use for 

which the licensee seeks approval. 

Therefore, it is necessary to identify the 

modalities that the individual 

performed and not ‘‘the uses [or 

procedures] covered by their board 

certification.’’ 

Comment: Two commenters 

supported the revisions to § 35.57 with 

respect to the Ritenour Petition. 

However, the commenters stated that 

the preceptor statements should not be 

required for those individuals 

requesting to be grandfathered under the 

provisions of § 35.57. 

Response: No change was made to the 

rule text based on these comments. The 

revised rule text in §§ 35.50, 35.51, 

35.55, 35.190, 35.290, 35.390, 35.392, 

35.394, 35.490, 35.590, and 35.690 also 

applies to board-certified individuals 

under § 35.57 and does not require 

preceptor statements for individuals 

who are qualified to be authorized 

under the board certification T&E 

requirements. 

Comment: Two commenters requested 

that individuals meeting the board 

certification requirements in 

§ 35.57(a)(2), (a)(3), and (b)(2) must be 

immediately grandfathered because the 

NRC failed to respond to the Ritenour 

Petition in a timely manner. Further, the 

commenters stated that these 

individuals should not have to fulfill 

the burdensome ‘‘alternate pathway’’ or 

preceptor attestation if they wish to 

become authorized on a license, but 

have not been so named by an NRC or 

Agreement State license. 

Response: No change was made to the 

rule text based on these comments. The 

NRC recognizes that individuals may 

not have been listed on a license but 

were practicing certain modalities on or 

before October 24, 2005. Individuals 

meeting the board certification 

requirements in § 35.57 have to provide 

evidence that they practiced the 

modalities for which they are seeking 

authorized status and may also have to 

provide evidence of continuing 

education and experience if it has been 

more than 7 years since their 

certification. Individuals being 

grandfathered under the provisions of 

§ 35.57(a)(2), (a)(3), and (b)(2) do not 

need preceptor attestations and do not 

need to meet the training requirements 

of the alternate pathway. 

Comment: Two commenters requested 

that the NRC consider removing dates 

from the board certification 

requirements for the currently 

recognized boards, as well as the boards 

affected by the Ritenour Petition. They 

based the request on their assertion that 

there has not been any evidence of an 

ME or regulatory violation before 2005 

or since that has demonstrated, or even 

suggested, that the year of board 

certification has any association with 

better or worse regulatory compliance or 

radiation safety. 

Response: No change was made to the 

rule text based on these comments. The 

NRC is retaining the board certification 

dates for all boards recognized under 

the requirements in 10 CFR part 35. 

This is because the boards change their 

certification processes; no longer certify 

individuals for life; and, in some cases, 

only guarantee the certification status 

for a few years requiring verification of 

the current certification status of its 

diplomates. Further, the NRC does not 

require reporting of the board 

certification status of an individual 

associated with an ME or a violation of 

NRC requirements. 

Section 35.65 Authorization for 

Calibration, Transmission, and 

Reference Sources 

Comment: One commenter noted that 

the explanation for the proposed 

changes for § 35.65 in the Federal 

Register notice stated that there were 

two new paragraphs whereas the text 

contained three new paragraphs. 

Response: The NRC agrees with the 

commenter’s observation. Section VI, 

Section-by-Section Analysis, of this 

document indicates that three new 

paragraphs were added to § 35.65. 

Comment: One commenter stated that 

the transmission sources should be 

removed entirely from §§ 35.65 and 

35.500 and should be placed in 

§ 35.200. Additionally, the commenter 

stated that the use of spot markers/ 

anatomical markers should be added to 

§ 35.200 because they are used on 

patients and are not used for instrument 

calibration purposes. The commenter 

explained that transmission sources, 

unlike sources currently in § 35.500, are 

not used to render a diagnosis and are 

not consistent with that category of use. 

The commenter agreed with the NRC 

that materials authorized by § 35.65 

should be prohibited for human use but 

went further to say that sources 

authorized by § 35.65 should be limited 

to only non-human use including 

calibration and reference sources for 

instrument/equipment calibration and 

testing. The commenter further 

recommended that the text proposed in 

§ 35.500 should be edited and moved to 

§ 35.200. 

Response: No change was made to the 

rule text based on this comment. The 

final rule clarifies that some sealed 

sources authorized under § 35.65 may 

be used under both §§ 35.65 and 35.500. 

Furthermore, sources that meet the 

§ 35.65 criteria are not required to be 

listed on a license when they are used 

under the provisions of § 35.500. The 

NRC considers the use of a transmission 

source to be diagnostic medical use 

when a patient is exposed to its 


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radiation. Additionally, § 35.200, which 

authorizes the medical use of unsealed 

byproduct material, is not the 

appropriate section for sealed sources. 

Comment: Several commenters stated 

that referring to § 35.500 in the 

proposed rule text in § 35.65 was 

confusing. They recommended that the 

phrase ‘‘except in accordance with the 

requirements in § 35.500’’ be removed 

from § 35.65(b)(1). They stated that the 

sources in § 35.65 do not need to be 

listed on a license but the current 

regulation in § 35.500 requires that 

sources and users be listed on a license. 

Furthermore, the commenters stated 

that sources in § 35.65 are to be used for 

reference, transmission, and calibration, 

but sources in § 35.500 are to be used for 

diagnosis. 

Response: No change was made to the 

rule text based on these comments. The 

rule text was not changed because 

removal of the phrase ‘‘except in 

accordance with the requirements in 

§ 35.500’’ would change paragraph (b)(1) 

to read that the byproduct material 

authorized under § 35.65 would not be 

permitted for medical use. For example, 

removing this text would prohibit the 

use of a transmission source when a 

patient is exposed to its radiation, 

which is a diagnostic medical use. 

Comment: One commenter noted that 

it listed transmission sources and 

transmission source devices on medical 

use licenses. It was ‘‘unaware of any 

circumstances in which a licensee 

bundled sources currently authorized by 

35.65 (individual source activity limit) 

in aggregation that are not listed or 

approved in the SS&D registry.’’ The 

commenter stated ‘‘that the proposed 

rule should be modified to clearly 

distinguish authorization for medical 

use and instrument calibration.’’ 

Response: No change was made to the 

rule text based on this comment. The 

commenter noted correctly that 

licensees cannot use sealed sources in a 

manner inconsistent with the sealed 

source and device registry (SSDR). The 

SSDR does not prohibit the ‘‘bundling’’ 

of sealed sources to create a greater 

source activity, but § 35.65 limits the 

activity of each sealed source authorized 

under this section. Some licensees have 

interpreted § 35.65 incorrectly to mean 

that these sealed sources could be 

bundled to create an aggregated source 

with a greater activity than is allowed. 

The rule change makes it clear that the 

maximum activity authorized by § 35.65 

applies to all sealed sources whether 

used singularly or in a bundled 

configuration. 

The NRC reviewed the rule language 

and believes it is clear that when sealed 

sources are used as part of a diagnostic 

medical procedure, these uses are 

authorized under § 35.500. Possession of 

the sources may be authorized under 

§ 35.65, but medical use of the sources 

is only authorized under § 35.500. For 

example, a transmission source may be 

possessed under § 35.65, but can only be 

used as part of a medical diagnostic 

procedure under § 35.500. 

The Following Comments Were 

Common to the Training and Experience 

Requirements in Sections 35.51, 35.190, 

35.290, 35.390, 35.392, 35.394, 35.396, 

35.490 and 35.690 

Comment: Several commenters agreed 

with the NRC’s proposal to remove the 

preceptor attestation requirements for 

individuals seeking authorized status 

via the board certification pathway. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: Several commenters agreed 

with the proposed change to the 

attestation language from ‘‘achieved a 

level of competency to function 

independently’’ to ‘‘verify that the 

individual can independently fulfill the 

radiation safety-related duties’’ for those 

individuals applying through the 

alternate pathway. They further stated 

that the term ‘‘competency’’ has certain 

implications and liabilities in the 

medical domain that should not factor 

into an attestation statement, which is 

meant to assure regulators that the 

individual received an adequate amount 

of radiation safety-specific T&E. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter noted that 

based on the revision to the T&E 

requirements, an individual who is 

board certified will no longer need a 

preceptor attestation to become an AU 

or AMP. Further, the commenter noted 

that the argument for this change is that 

some preceptors have been reluctant to 

attest due to concerns related to 

personal liability based on possible 

future actions of the proposed AU or 

AMP. The commenter stated that if 

someone truly has these reservations, 

there may be a good reason they are not 

willing to sign off on the attestation. 

Response: No change was made to the 

rule text based on this comment. The 

NRC believes that certification by a 

specialty board coupled with the 

recentness of training requirements in 

§ 35.59 and, as appropriate, the 

requirements in §§ 35.50(d), 35.51(c), 

35.390(b)(1)(ii)(G), or 35.690(c) is 

sufficient to demonstrate that the 

individual seeking authorization on a 

license has met the T&E requirements in 

the board certification pathway. The 

NRC concluded that these three 

elements show the individual has the 

requisite knowledge and that an 

additional attestation is not necessary. 

For the non-board certified applicants, 

the attestation requirement is retained 

but the attestation language is revised in 

response to concerns that preceptors are 

reluctant to sign preceptor attestations 

due to personal liability concerns. 

Comment: Two commenters endorsed 

retaining the attestation requirement for 

those individuals pursuing initial board 

certification (but not yet certified) and 

alternate pathways. The commenters 

stated that retaining the preceptor 

attestation helps ensure accountability 

and credibility by clearly identifying an 

AU who can attest that the individual 

has satisfactorily completed the 

required NRC training. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter pointed 

out that the correct terminology for the 

American Osteopathic Association 

residency approval organization is the 

‘‘Council on Postdoctoral Training.’’ 

Response: The rule text was modified 

based on this comment. The rule text is 

changed to replace the ‘‘Committee on 

Post-Graduate Training’’ with the phrase 

‘‘Council on Postdoctoral Training.’’ 

Comment: One commenter supported 

permitting residency program directors 

to provide attestations based on the 

consensus of the residency faculty. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter 

recommended that the NRC recognize 

the Nuclear Medicine Advanced 

Associate (NMAA) position as an AU for 

§ 35.100 and § 35.200 medical uses. The 

commenter described the NMAA as a 

physician extender in Nuclear Medicine 

who has been trained at the master’s 

level, tested, and board certified in 

advanced nuclear medicine practice. 

The commenter stated that: 

[t]he nuclear medicine advanced associate 

prescribes and administers pharmacologic 

and non-pharmacologic interventions under 

the direction of the supervising physician 

and, as indicated by patient profile and 

diagnostic procedure as allowable by state 

and federal statutes, which includes, but is 

not limited to: 

1. Perform pre-procedure requirements and 

interventions as may be required. 

2. Perform intra-procedure requirements as 

may be required. 

3. Perform post-procedure requirements as 

may be required. 

The commenter clarified that, as with 

other physician extenders, i.e., 

physician assistants and nurse 


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practitioners, NMAAs are allowed to 

prescribe substances that are allowed 

under the scope of their practice, such 

as radiopharmaceuticals. The 

commenter believes that this opens the 

pathway for physician extenders in 

nuclear medicine to become authorized 

users, just as physician assistants and 

nurse practitioners are allowed to 

prescribe medications on behalf of their 

supervising physicians. The commenter 

believes that the training and practical 

experience of NMAAs creates ideal 

candidates for AUs and that the NMAA 

has met the qualifications required 

under § 35.200 to become AUs. The 

commenter concluded that the NRC 

should also recognize their board 

certification (Nuclear Medicine 

Technology Certification Board 

(NMTCB)) under §§ 35.190 and 35.290. 

The commenter recommended that 

NMAAs be added to the candidates for 

authorized user for radioactive 

byproduct materials use for uptake, 

dilution, excretion, imaging and 

localization and that their board 

certification be added to NRC 

recognized boards. The commenter 

proposed specific rule text to 

accomplish this. 

Response: No change was made to the 

rule text based on this comment. The 

comment is outside the scope of this 

rulemaking. Currently, an AU under 

§ 35.190, ‘‘Training for uptake, dilution, 

and excretion studies,’’ or § 35.290, 

‘‘Training for imaging and localization 

studies,’’ must be ‘‘a physician.’’ An AU 

is defined at § 35.2 as ‘‘a physician, 

dentist, or podiatrist . . .’’ and a 

physician is defined as ‘‘a medical 

doctor or doctor of osteopathy licensed 

. . . to prescribe drugs in the practice of 

medicine.’’ AU recognition under 

§§ 35.190 and 35.290 is currently 

limited to physicians because these T&E 

requirements and board recognition 

criteria are premised on the high level 

of education and training obtained by 

medical doctors and doctors of 

osteopathy who are licensed to practice 

medicine. These T&E requirements are 

not premised on the level of education 

and training obtained by physician 

extenders or assistants. These T&E 

requirements ensure that AUs use 

byproduct material for medical 

purposes in a way that is radiologically 

safe for workers, patients, and the 

public. The change that the commenter 

requests would require the NRC to 

consider whether it is acceptable, from 

a radiological health and safety 

standpoint, to permit physician 

extenders or assistants such as NMAAs 

to be eligible to become AUs. Such a 

change is outside the scope of this 

rulemaking. Moreover, before making 

any such change, the NRC would need 

to carefully consider the radiological 

health and safety issues attendant to 

such a change and consult with the 

ACMUI. Although the commenter’s 

recommendation is outside the scope of 

this rulemaking, the commenter may 

submit a petition for rulemaking on this 

issue pursuant to § 2.802. 

Section 35.204 Permissible 

Molybdenum-99, Strontium-82, and 

Strontium-85 Concentrations 

Comment: Several commenters agreed 

with the proposed changes to measure 

every elution. One commenter noted 

that the new elution requirements are 

already included in standards of 

practice and manufacturer 

recommendations. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter noted that 

Tc-99m decays much faster than Mo-99; 

therefore, every Tc-99m generator eluate 

will eventually exceed the regulatory 

limit. Because of this, the commenter 

stated that the language in the proposed 

rule text would require every eluate to 

be reported. The commenter proposed 

revising the rule text in § 35.204(e) to 

clarify that the licensee would only 

report measurements of a Tc-99m 

generator elution that exceeded the 

regulatory limits at the time of generator 

elution. 

Response: The rule text was modified 

based on this comment. The NRC agrees 

with the commenter that the proposed 

rule text was not clear in § 35.204(e) and 

has amended it to clarify that the 

reporting requirements only apply at the 

time of generator elution. 

Comment: One commenter stated that 

on two occasions in the last 10 years its 

generator elution measurements 

exceeded the regulatory limit, but on 

subsequent elutions, the measurements 

were below the limit. The Tc-99m from 

these subsequent elutions was used for 

patients. The commenter recommended 

that the reporting requirement of 

§ 35.204 be revised to require a licensee 

to report to the NRC and the 

manufacturer or the distributor of 

medical generators within 30 days when 

‘‘consecutive measurements on the same 

generator’’ exceed the limits specified in 

§ 35.204(a). 

Response: No change was made to the 

rule text based on this comment. The 

commenter suggested changing the 

regulation to require consecutive 

measurements on the same generator to 

exceed the regulatory limits before 

reporting the failure. The ratio of Mo-99 

to Tc-99m measured in any eluate 

intended for patient use must never 

exceed the regulatory limits. Because 

safety of patients is paramount, 

reporting any failure to the NRC and the 

distributor, which may also sometimes 

be the manufacturer, allows for 

determinations to be made and actions 

to be taken to prevent similar 

occurrences. If any eluate measurement 

exceeds the regulatory limit, the 

generator should be removed from 

service until the cause is determined. 

Comment: One commenter suggested 

revising § 35.204(b) to remove the 

phrase ‘‘after receipt’’ in the proposed 

requirements to measure the eluate from 

the generator in order to demonstrate 

compliance with the regulations 

because measuring the eluate after 

receipt of the generator is already 

implied. 

Response: The rule text was modified 

based, in part, on this comment. The 

rule text was changed to delete ‘‘after 

receipt’’ in § 35.204(b). The previously 

proposed language could be subject to 

misinterpretation by the regulated 

community and, as suggested by the 

commenter, measuring the eluate after 

receipt of the generator is already 

implied. Deletion of ‘‘after receipt’’ 

more clearly describes the intent of this 

change to the regulation that each and 

every eluate intended for medical use of 

each generator must be tested for 

breakthrough. 

Section 35.300 Use of Unsealed 

Byproduct Material for Which a Written 

Directive Is Required 

Comment: One commenter questioned 

the statement about § 35.300 in the 

‘‘Discussion of Proposed Amendments 

by Section’’ in the Federal Register 

notice for the proposed rule. The 

statement was that an AU may be 

authorized for one or more of the 

specific categories described in 

§ 35.390(b)(1)(ii)(G), but not for all 

unsealed byproduct material. The 

commenter specifically wanted to know 

what other unsealed therapeutic 

byproduct material is referenced and 

why a trained and experienced AU 

could not be authorized for all unsealed 

therapeutic byproduct material. 

Response: No change was made to the 

rule text based on this comment. Any 

new unsealed byproduct material 

requiring a WD that is not specifically 

addressed in § 35.390(b)(1)(ii)(G) would 

be regulated under the provisions of 

§ 35.1000. This allows the NRC to 

evaluate each new radionuclide for 

possible unsealed byproduct material 

use and determine whether it falls 

within the scope of § 35.390(b)(1)(ii)(G) 

or instead should be regulated under the 

provisions of § 35.1000. 


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Section 35.390 Training for Use of 

Unsealed Byproduct Material for Which 

a Written Directive Is Required 

Comment: One commenter suggested 

the elimination of the attestation 

requirement for physicians meeting the 

‘‘alternate pathway’’ T&E criteria in 

§ 35.390(b) as was done for the ‘‘board 

certification pathway’’ under 

§ 35.390(a). 

Response: No change was made to the 

rule text based on this comment. The 

NRC is retaining the attestation 

statement requirement for individuals 

authorized under the ‘‘alternate 

pathway’’ provisions. This is because it 

is important to know that the individual 

not only successfully completed the 

T&E requirements but is also able to 

independently fulfill the radiation 

safety-related duties of an AU. 

Comment: One commenter believed 

the use of the word 

‘‘radiopharmaceutical’’ in the 

introduction section of 

§ 35.390(b)(1)(ii)(G) and the phrase ‘‘any 

radionuclide’’ in the parenteral 

administration regulations (i.e., 

§ 35.390(b)(1)(ii)(G)(3) or (b)(1)(ii)(G)(4)) 

was confusing and would permit the use 

of a radionuclide that is not a 

component of a radiopharmaceutical. 

The commenter used the example of 

yttrium-90 (Y-90) microspheres 

containing the radionuclide Y-90. The 

commenter recommended revising the 

wording in § 35.390(b)(1)(ii)(G)(3) and 

(b)(1)(ii)(G)(4) to say, ‘‘Parenteral 

administration of any radioactive 

drug. . . .’’ 

Response: The rule text was modified 

based on this and other comments. The 

rule text was changed to include the 

phrase ‘‘radioactive drug that contains 

a’’ in § 35.390(b)(1)(ii)(G)(3). The NRC 

agrees that the proposed language could 

be clearer. Additionally, based on a 

recommendation from the ACMUI, the 

NRC deleted § 35.390(b)(1)(ii)(G)(4) and 

included radioactive drugs primarily 

used for their alpha characteristics in 

§ 35.390(b)(1)(ii)(G)(3). 

Comment: One commenter stated that 

both the current and proposed 

categories in § 35.390(b)(1)(ii)(G)(3) and 

(4) are confusing. The commenter asked 

what the purpose is for specifying the 

150 keV limit in category (3). The 

commenter stated that if there is a new 

use for a photon emission greater than 

150 keV then there is no provision for 

it under the regulations. 

Response: No change was made to the 

rule text based on this comment. The 

NRC believes it is unlikely that there 

will be a radioactive drug requiring a 

WD that will be used primarily for its 

photon energy greater than 150 keV. 

However, as stated in 

§ 35.390(b)(1)(ii)(G), any radioactive 

drugs not specifically addressed in 

paragraph (G) would be regulated under 

the provisions of § 35.1000. 

Comment: One commenter stated that 

§ 35.390(b)(1)(ii)(G)(4) would require an 

AU currently authorized under 

§ 35.390(b)(1)(ii)(G)(3) to administer 

radium-223 dichloride to obtain 

additional work experience, unless 

revisions are made to § 35.57. The 

commenter stated that these physicians 

do not need additional training to use 

materials for which they are already 

authorized. 

Response: The rule text was modified 

based on a recommendation from the 

ACMUI. The NRC revised § 35.57(b)(1) 

to grandfather physicians for those 

medical uses for which they were 

authorized prior to the effective date of 

the rule. Also, the NRC deleted 

§ 35.390(b)(1)(ii)(G)(4) and included 

radioactive drugs primarily used for 

their alpha characteristics in 

§ 35.390(b)(1)(ii)(G)(3). These changes 

ensure that physicians already using Ra223 dichloride at the time the rule 

becomes effective are permitted to 

continue use of the radioactive drug. 

Comment: Several commenters 

questioned the purpose of the proposed 

paragraph (c) in § 35.390 that applied 

only to parenteral administrations. They 

questioned how a physician could be an 

AU under the provisions of § 35.390 

without completing the I–131 cases 

listed in § 35.390(b)(1)(ii)(G). The 

commenters questioned whether 

paragraph (c) should be moved to 

§ 35.396. 

Response: The rule text was modified 

based on these and other comments. 

Section 35.390(c) was removed in the 

final rule because § 35.390(b)(1)(ii)(G)(3) 

and (4) was merged into one category of 

parenteral administrations of 

radioactive drugs in the final rule in 

response to a recommendation from the 

ACMUI. Section 35.390(c) was no longer 

needed with this revision in the final 

rule. Section 35.390(b)(ii)(G) now has 

three separate categories of radioactive 

drugs, and a proposed AU is evaluated 

and authorized for each category 

separately. The NRC recognizes that 

individuals that are board certified or 

have completed the other T&E criteria 

under § 35.390 may not have completed 

their supervised work experience 

administering all the categories of 

radioactive drugs in § 35.390(b)(1)(ii)(G). 

These individuals will be authorized for 

only those categories for which they 

have completed their T&E. 

Comment: Several commenters 

opposed the proposed new dosage 

category for alpha emitters under 

§ 35.390(b)(1)(ii)(G)(4) because it would 

require physicians authorized for the 

parenteral administration of radioactive 

drugs containing radionuclides used 

primarily for their electron emitters or 

for its photon energy of less than 150 

keV to have additional work experience 

involving dosage administrations in a 

minimum of three cases to attain AU 

status. The commenter pointed out that 

under the proposed regulations, those 

seeking to administer both types would 

need work experience in a minimum of 

six cases of administration, three with 

alpha emitters and three with beta 

emitters. The commenter referenced the 

ACMUI recommendation not to separate 

the parenteral administration of beta 

and gamma-emitting 

radiopharmaceuticals from the alphaemitting radiopharmaceuticals. The 

commenter also stated that according to 

the ACMUI, the NRC staff has not 

provided a compelling radiation safety 

justification for emission-specific T&E 

requirements. 

Response: The rule text was modified 

based on a recommendation from the 

ACMUI. Section 35.390(b)(1)(ii)(G)(4) 

was deleted and provisions within that 

section have been incorporated into 

§ 35.390(b)(1)(ii)(G)(3). The category 

‘‘parenteral administration of any 

radioactive drug that contains a 

radionuclide that is primarily used for 

its alpha radiation characteristics, for 

which a written directive is required’’ is 

now included in § 35.390(b)(1)(ii)(G)(3). 

The NRC has determined that an AU 

who is authorized under 

§ 35.390(b)(1)(ii)(G)(3) would not need 

three additional cases to administer 

alpha-emitting radioactive drugs. 

Comment: One commenter believed 

NRC’s separation of categories in 

§ 35.390(b)(ii)(G)(3) and 

35.390(b)(ii)(G)(4) based on the primary 

emission used for medical use was not 

the best approach. The commenter cited 

Lutetium-177 as an example of a 

radionuclide with a significant gamma 

emitting branch with energy exceeding 

150 keV. The commenter proposed the 

distinction be based on the prevalence 

of gamma emissions greater than 150 

keV. The commenter’s proposal was to 

modify § 35.390(b)(ii)(G)(3) to read, 

‘‘Parenteral administration for which a 

written directive is required of any 

radionuclide which emits a photon with 

energy greater than 150 keV in less than 

or equal to 10% of all decays, or of any 

less than 1.0 GBq (27 mCi) of any other 

radionuclide;’’ and modify 

§ 35.390(b)(ii)(G)(4) to read, ‘‘Parenteral 

administration for which a written 

directive is required of 1.0 GBq (27 mCi) 

or more of any radionuclide which 

emits a photon with energy greater than 


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150 keV in more than 10 percent of all 

decays.’’ The commenter concluded that 

most, if not all alpha emitters, would be 

in the newly defined category 3 and be 

consistent with the placement of 

radium-223 dichloride. 

Response: No change was made to the 

rule text based on this comment. The 

commenter provided an alternative 

approach for categorizing various 

radioactive drugs for parenteral 

administration, but the NRC believes 

that the categorization is better 

delineated based upon the most 

clinically effective emissions of the 

radioactive drug requiring a WD. The 

commenter’s proposal would result in 

implementation difficulties without a 

commensurate increase in safety. 

Further, the NRC deleted 

§ 35.390(b)(1)(ii)(G)(4) and included 

radioactive drugs primarily used for 

their alpha characteristics in 

§ 35.390(b)(1)(ii)(G)(3). 

Comment: One commenter 

recommended eliminating the separate 

dosage category used primarily for alpha 

emitters. The commenter suggested that 

if a new radioactive drug became 

available that was more hazardous than 

radium-223 dichloride and warranted 

additional radiation safety regulatory 

requirements, then NRC could license it 

under the provisions of § 35.1000. 

Response: The rule text was modified 

based on a recommendation from the 

ACMUI. The NRC deleted 

§ 35.390(b)(1)(ii)(G)(4) and included 

radioactive drugs primarily used for 

their alpha characteristics in 

§ 35.390(b)(1)(ii)(G)(3). The NRC 

anticipates that all radioactive drugs 

that will be used for their alpha-emitting 

characteristics can be regulated under 

§ 35.390(b)(1)(ii)(G)(3). However, the 

NRC may regulate radionuclides under 

§ 35.1000 as appropriate. 

Comment: One commenter noted that 

NRC regulations are designed to provide 

flexibility for emerging technologies and 

could be adjusted to recognize that 

alpha and beta emitters are a new class 

of therapeutic radiopharmaceutical 

products. The commenter referenced 

Radium-223 dichloride and a potential 

new actinium alpha emitter. The 

commenter suggested that the NRC 

should create a new T&E requirement 

specific to therapeutic 

radiopharmaceuticals based upon their 

unique characteristics, typical setting 

for administration, and safety record 

(such as was done for sodium iodide I131 at §§ 35.392 and 35.394). The NRC 

could give license applicants an option 

to petition NRC for review under 

§ 35.1000 for a drug that technically fits 

within the four categories listed in 

§ 35.390(b)(1)(ii)(G), but is deserving of 

an individualized T&E requirement 

review, due to its administration profile 

and safety characteristics. 

Response: No change was made to the 

rule text based on this comment. The 

NRC’s regulations under § 35.1000 allow 

the NRC to determine when a particular 

medical use of byproduct material or 

radiation from byproduct material 

should be regulated under § 35.1000. In 

accordance with § 35.12(d), the NRC 

will license a new radionuclide under 

§ 35.1000 if it has unique properties that 

prohibit it from meeting existing 

requirements or if additional 

requirements are needed for safety. 

When a radionuclide is licensed under 

§ 35.1000, specific T&E requirements are 

included in the licensing guidance for 

that particular radioactive drug. 

Comment: Several commenters stated 

it would be difficult for AUs to get the 

additional supervised work experience 

associated with three cases using 

radioactive drugs containing 

radionuclides used primarily for their 

alpha emissions. One commenter 

pointed out that there is only one FDAapproved alpha-emitting radioactive 

drug and that it is used in a limited 

population. Several other commenters 

stated that patients who do not live near 

teaching hospitals and urban centers 

may have limited access to radioactive 

drugs in the two parenteral categories. 

Certain practitioners, particularly those 

in areas far removed from teaching 

hospitals and urban centers, may find it 

too burdensome to participate in three 

proctored cases in each of these very 

specific categories. 

Several commenters stated that the 

proposed changes in § 35.390(b)(1)(ii)(G) 

would discourage clinicians from 

seeking authorization to administer 

these radioactive drugs and would make 

an already burdensome regulatory 

scheme more onerous. The commenters 

suggested that the NRC revise the 

proposed work experience requirement 

in categories in § 35.390(b)(1)(ii)(G)(3) or 

35.390(b)(1)(ii)(G)(4) to have three 

proctored cases in either category be 

satisfactory to meet the requirements for 

both categories. 

Several commenters acknowledged 

that the clarifications of the categories of 

parenteral administrations were useful 

and logical. However, they agreed with 

another commenter that there was an 

unintended consequence of increasing 

the work experience burden for those 

seeking administration of 

radiopharmaceuticals with alpha and 

beta emitters. 

Response: The rule text was modified 

based on a recommendation from the 

ACMUI. The NRC deleted 

§ 35.390(b)(1)(ii)(G)(4) and included 

radioactive drugs primarily used for 

their alpha characteristics in 

§ 35.390(b)(1)(ii)(G)(3). 

Section 35.396 Training for the 

Parenteral Administration of Unsealed 

Byproduct Material Requiring a Written 

Directive 

Comment: One commenter supported 

changes in the proposed rulemaking to 

permit physicians who have completed 

the 80 hours of classroom and 

laboratory training specified in 

§ 35.396(d)(1) and who have the 

relevant work experience described in 

§ 35.396(d)(2) to be eligible for AU 

status to administer parenteral 

radioactive drugs. The commenter 

stated that this is an appropriate level of 

T&E for administration by hematologists 

and oncologists of a specific radioactive 

drug, Zevalin®, used primarily for its 

beta emissions. 

Response: No change was made to the 

rule text based on this comment. The 

NRC did not intend to propose any 

change to this T&E requirement in the 

proposed rule, and, therefore has not 

developed the regulatory basis to make 

any change to this requirement in this 

final rule. During the preparation of the 

proposed rule, an administrative error 

resulted in the addition of the word 

‘‘or’’ between the rule text in § 35.396(c) 

and (d). The NRC did not intend to put 

an ‘‘or’’ between paragraphs (c) and (d) 

and is correcting the error by removing 

the word ‘‘or’’ in the final rule text 

between paragraphs (c) and (d). This 

administrative error could have been 

interpreted to require that a physician 

complete only 80 hours of T&E for 

parenteral administration of unsealed 

byproduct material requiring a WD. 

The NRC notes that to obtain 

authorization to use parenteral 

radioactive drugs requiring a WD, the 

physician must either (1) meet the T&E 

requirement or be certified by a medical 

specialty board recognized under 

§ 35.390 and meet the clinical case work 

criteria in § 35.390, or (2) meet the T&E 

requirement or be certified by a medical 

specialty board recognized under 

§§ 35.490 or 35.690 and satisfy the 

additional 80 hours of T&E requirement 

specified in § 35.396(d). 

Comment: Two commenters stated 

that NRC’s regulations create a shortage 

of AUs able to administer certain 

therapeutic radioactive drugs. 

Specifically, under current regulations, 

a radioactive drug requiring a WD that 

is administered parenterally and used 

primarily for its beta radiation 

characteristics can only be administered 

by an AU who has met the T&E 

requirement set forth in § 35.396. This 

requirement involves either board 


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certification or 700 hours of T&E 

specifically in radionuclide handling. 

One of the commenters stated that 

hematologists and oncologists who 

typically prescribe therapeutic 

radiopharmaceuticals outside of the 

hospital setting often do not have the 

T&E required to meet the AU 

requirements and do not work at 

facilities that have such AUs. They have 

extensive T&E, and are frequently board 

certified, but in different specialized 

fields. 

Response: No change was made to the 

rule text based on these comments. The 

NRC believes that the commenters are 

referring to the requirement in § 35.390, 

because the 700 hour criterion is in 

§ 35.390 and not in § 35.396. 

Without compromising radiological 

health and safety, the NRC strives to 

ensure that its regulations do not restrict 

patient access to diagnostic and 

treatment options. The intent of NRC’s 

T&E requirements is to ensure that AUs 

are adequately trained so that their 

handling and administration of 

radioactive drugs is radiologically safe 

for patients, workers, and the public. 

The current T&E requirements are 

protective of radiological health and 

safety. As explained in greater detail in 

a response to another comment on 

parenteral administrations, throughout 

2015 and early 2016 the ACMUI 

assessed the concerns raised in this 

comment. Additionally, the ACMUI 

established a standing subcommittee 

that will periodically assess the T&E 

requirements across all modalities and 

make recommendations for changes as 

warranted. The NRC will also continue 

to consider whether changes to these 

T&E requirements are warranted. 

With respect to the comment that 

hematologists and oncologists ‘‘typically 

prescribe therapeutic 

radiopharmaceuticals . . . ,’’ the NRC 

regulations require that such 

radiopharmaceuticals be administered 

in accordance with a WD. A WD is an 

AU’s—not a hematologist’s or 

oncologist’s—written order for the 

administration of byproduct material or 

radiation from byproduct material to a 

specific patient, as specified in § 35.40. 

Comment: Several commenters 

provided comments after the public 

comment period on whether the NRC 

should amend the T&E requirement for 

the parenteral administration of 

radioactive drugs as part of this final 

rule. 

One commenter stated that amending 

§ 35.396 to reduce the T&E requirement 

to 80 hours in this final rule would be 

a logical outgrowth of the proposed rule 

and thus would satisfy the 

Administrative Procedure Act of 1946 

(APA) requirement to provide notice 

and an opportunity for comment. The 

commenter stated that the NRC 

provided adequate notice of an 

amendment to this T&E requirement 

and that the NRC received substantial 

public input on these T&E requirements. 

Alternatively, according to the 

commenter, the NRC could invoke the 

‘‘good cause’’ exemption from the APA 

notice and comment requirements 

because the 700 hour T&E requirement 

for these parenteral radioactive drugs 

has caused a decrease in the number of 

AUs for these drugs and a 

corresponding decrease in patient 

access to these drugs. The commenter 

also proposed that the NRC could, 

instead of amending T&E requirements 

at § 35.396(d), include in this final rule 

a new section that would require 80 

hours of T&E specifically for the 

parenteral administration of patientready doses of alpha- and beta-emitting 

radioactive drugs. One other commenter 

also supported reducing this T&E 

requirement to 80 hours as part of this 

final rule and provided a proposed 

training program. 

Several other commenters also 

expressed support for reducing this T&E 

requirement in this final rule. The 

commenters asserted that the 700 hour 

T&E requirement has caused a lack of 

AUs available to administer these 

radioactive drugs; administration of 

these drugs presents no greater radiation 

health and safety risk than oral 

administration of I-131; and 80 hours of 

T&E is sufficiently protective of 

radiological health and safety. 

Several commenters opposed 

changing this T&E requirement in the 

final rule. One commenter stated that 

the NRC and ACMUI would need to 

analyze key issues before proposing any 

changes to this T&E requirement, 

including whether a reduction in the 

requirement is advisable from a 

radiation health and safety perspective. 

These commenters stated that an AU 

would need to receive adequate training 

on a broad array of radiation health and 

safety topics and that an 80-hour course 

would not sufficiently cover these 

topics. These commenters also 

described the range of activities, 

considerations, and procedures 

necessary to ensure the safe handling 

and administration of these radioactive 

drugs. 

Response: No change was made to the 

rule text based on these comments. As 

stated in response to another comment 

on § 35.396, the proposed rule text that 

could have been interpreted to require 

only 80 hours of T&E for a physician to 

obtain AU status to administer 

parenteral radioactive drugs was the 

result of an administrative error. The 

NRC did not mention or discuss any 

changes to these T&E requirements in 

any other part of the proposed rule 

Federal Register notice. The NRC did 

not intend to propose any changes to 

this T&E requirement, and therefore the 

NRC has not developed a regulatory 

basis to make any such change in this 

final rule. The NRC agrees with the 

comment that, before proposing any 

changes to this T&E requirement, the 

NRC and ACMUI should analyze 

whether a change in the requirement is 

warranted and advisable from a 

radiation health and safety perspective. 

In response to commenter’s concerns 

about this T&E requirement, the NRC 

and ACMUI began considering whether 

a change in this requirement is 

warranted. Spectrum Pharmaceuticals, 

Inc. requested a meeting with NRC staff 

to explain its comments concerning this 

T&E requirement. The NRC staff agreed 

and held a public meeting on February 

12, 2015, at which Spectrum 

Pharmaceuticals, Inc. and Florida 

Cancer Specialists & Research Institute 

presented their comments and concerns 

that this T&E requirement causes a 

shortage of AUs, and, therefore a barrier 

to patient access. In response to these 

comments and concerns, throughout 

2015 and early 2016 the ACMUI 

assessed whether this T&E requirement 

places a hardship on the patient 

community. In a public teleconference 

held on June 16, 2015, the Florida 

Cancer Specialists & Research Institute 

presented to the ACMUI its concerns 

that this T&E requirement caused a lack 

of AUs and thus a barrier to patient 

access to these radioactive drugs. After 

this teleconference, the ACMUI formed 

a subcommittee to assess whether the 

700 hour T&E requirement for 

parenteral administration of this class of 

radiopharmaceuticals places a hardship 

on the patient community by creating a 

shortage of AUs. In its subcommittee 

report dated September 21, 2015, which 

the ACMUI unanimously approved at its 

Fall 2015 meeting, the ACMUI 

concluded that it was unable to 

substantiate this claim. The ACMUI 

found that the infrequent and steadily 

decreasing use of specific beta-emitting 

radioactive drugs—specifically 

radioactive drugs that are used to treat 

lymphoma, such as Spectrum 

Pharmaceuticals, Inc.’s drug Zevalin®— 

is due to many factors. The ACMUI 

concluded that it could not determine 

whether there is a shortage of AUs and, 

if so, whether the NRC’s T&E 

requirement caused the shortage. The 

subcommittee was then charged with 

continuing to assess this issue and 


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establishing a recommendation for the 

total number of hours of T&E for AUs 

of this class of radioactive drugs that 

appropriately balances safety with 

reasonable patient access to these 

radioactive drugs. 

In its subcommittee report dated 

March 10, 2016, which the ACMUI 

unanimously approved at its meeting on 

this same date, the ACMUI reiterated its 

conclusion that it could not substantiate 

the claim that the T&E requirement 

caused a shortage of AUs and thus a 

hardship on the patient community. For 

this reason, and because the ACMUI 

identified several issues raised by the 

reduction in T&E requirements that 

some commenters recommended, the 

ACMUI recommended against reducing 

the T&E. However, the ACMUI 

recognized the need for a thorough 

review of T&E requirements across all 

modalities because of the introduction 

of new radioactive drugs since the 

requirements were established 15 years 

ago and because the educational 

paradigm has shifted from prescriptive 

curricula to competency-based 

education. The ACMUI established a 

standing subcommittee to assess T&E 

requirements for all modalities and 

provide recommendations to the NRC 

staff. As stated in response to other 

comments, the NRC will continue to 

consider concerns regarding T&E 

requirements to ensure that these 

requirements are sufficient to ensure 

radiological health and safety for 

patients, workers, and the public 

without unnecessarily creating barriers 

to patient access to diagnostic and 

treatment options. 

Section 35.400 Use of Sources for 

Manual Brachytherapy 

Comment: Several commenters did 

not agree with the proposal in § 35.400 

that manual brachytherapy sources may 

be used for medical purposes not listed 

in the SSDR. The commenters believed 

that this change would permit sources 

to be used by medical personnel who 

have not received any radiation safety 

training. As an example, they cited the 

case where brachytherapy sources are 

used in temporary diagnostic 

localization procedures under the 

provisions of § 35.1000. In this case, the 

guidance requires licensees to submit 

their training program for nonmedical 

staff that are not covered under their 

current medical license. The 

commenters believed that by requiring 

these uses under the provisions of 

§ 35.1000, the regulatory agencies can 

ensure that radiation safety for all 

workers is verified before use. 

Response: No change was made to the 

rule text based on these comments. 

Although the statement of 

considerations for the proposed rule 

stated ‘‘manual brachytherapy sources 

can be used for medical uses not listed 

in the SSDR’’, the rule text is more 

limiting and states ‘‘. . . manual 

brachytherapy sources may be used for 

manual brachytherapy uses that are not 

explicitly listed in the SSDR.’’ The 

commenters’ example of using a manual 

brachytherapy source for a temporary 

diagnostic localization procedure is not 

permitted under the provisions of 

§ 35.400 because it is a diagnostic use 

and not a manual brachytherapy use. 

However, such use may be authorized 

under the provisions of § 35.1000. 

Comment: One commenter agreed 

with the NRC that the limitations and 

consideration of use listed in the SSDR 

be followed. The commenter believed 

that the ‘‘SSDR reviewer should identify 

and list requirement [sic] and discuss 

issues on how to license these products 

for safe use.’’ The commenter stated 

that, by doing this, the SSDR reviewer 

helps ensure uniformity in the licensing 

requirements, and saves resources for 

industry and regulatory agencies in not 

having to independently obtain this 

information. 

Response: No change was made to the 

rule text based on this comment. The 

NRC revised § 35.400 because existing 

SSDR sheets do not, nor are they 

expected to, describe all manual 

brachytherapy medical procedures for 

which the manual brachytherapy seeds 

can be used. During the evaluation, the 

reviewer focuses on radiation safety 

conditions and limitations of use. 

Section 35.433 Strontium-90 Sources 

for Ophthalmic Treatments 

Comment: One commenter stated that 

the proposed regulations concerning 

ophthalmic physicists in § 35.433, 

which separate physicists who assist in 

ophthalmic procedures from AMPs who 

are involved in the uses allowed under 

§§ 35.600 and 35.1000, were an 

improvement. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter 

recommended a revision of 

§ 35.433(a)(2) to specifically include the 

term ‘‘ophthalmic physicist.’’ The 

commenter pointed out that although 

the NRC defined the ‘‘ophthalmic 

physicist’’ to be ‘‘an individual who 

meets the requirements of § 35.433(a)(2) 

. . . ,’’ the NRC did not use the term 

‘‘ophthalmic physicist’’ in § 35.433. The 

commenter recommends changing the 

text in § 35.433(a)(2) to read: An 

individual named as an ophthalmic 

physicist who: (i) Holds a masters . . .‘‘ 

Response: The rule text was modified 

based on this comment. The rule text 

was changed to include the term 

ophthalmic physicist in § 35.433(a)(2). 

The NRC agrees that, for clarity, the 

term ophthalmic physicist must be 

included in this section. By including 

the term ‘‘ophthalmic physicist,’’ it is 

clear that the requirements in 

§ 35.433(a)(2) apply to an individual 

who is named as an ophthalmic 

physicist and meets the definition of an 

‘‘ophthalmic physicist’’ in § 35.2. 

Comment: Several commenters 

questioned the need for § 35.433(b)(2) 

and recommended its removal. They 

thought that the actions regarding the 

WD were already required by the 

licensee in § 35.41 and that no other 

modality requires a procedure regarding 

the frequency of involvement by the 

medical physicist. The commenters also 

asked why the other individual 

[identified in § 35.433(b)(2)] could not 

work under the supervision of the AMP 

or request an exemption from the 

requirement. 

Response: No change was made to the 

rule text based on these comments. 

Although the regulations do not prohibit 

a licensee that has an AMP from also 

having an ophthalmic physicist, the 

primary purpose of the ophthalmic 

physicist is to provide physics support 

to the ophthalmic AU when the licensee 

does not have access to an AMP. The 

ophthalmic physicist is an individual 

recognized by the NRC, Agreement 

States, medical licensees of broad scope, 

master material licensees or master 

material medical permittees of broad 

scope by T&E, to perform certain 

functions listed under § 35.433. This 

individual is authorized to work 

independently and is not required to 

work under the supervision of an AMP. 

The purpose of § 35.433(b) is to 

describe the minimum performancebased tasks expected of either the AMP 

or the ophthalmic physicist in assisting 

the licensee and AU with the 

ophthalmic treatment program. The 

requirement that only an AMP shall 

calculate the activity of each Sr-90 

source is an existing requirement in the 

regulations under § 35.433(a) and is not 

a new requirement. The requirement in 

§ 35.433(b)(2) codifies that the AMP, or 

ophthalmic physicist, is to assist the 

licensee and AU in assuring that the 

requirements in § 35.41 are met. 

Ophthalmologists using these devices 

are frequently in small programs with 

limited access to services of an AMP. 

The proposed rule change was made in 

part to ensure that the ophthalmic 

physicist (or AMP) performs a minimum 

number of tasks at the ophthalmology 

office. 


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The NRC did not specify the 

frequency of involvement of the AMP or 

ophthalmic physicist because the 

licensee should determine the best 

frequency for its program. The NRC 

requires AMPs to perform certain tasks 

at specified frequencies for certain 

medical use programs. Specifically, 

AMPs are required to participate 

initially, and at least annually, in drills 

of emergency procedures under 

§ 35.610. They also must be physically 

present during initiation of patient 

treatment, continuation of the treatment, 

or the entire treatment, depending on 

the unit being used under § 35.615. In 

addition, AMPs must perform the full 

calibration measurements and decay 

corrections before first medical use, 

before medical use under certain 

conditions, and at intervals not to 

exceed one year under §§ 35.632, 

35.633, and 35.635. 

Comment: An Agreement State 

pointed out that in its State statutes, an 

individual who practices medical 

physics is required to be licensed by the 

State. Because § 35.422 is designated as 

‘‘Health and Safety’’ (H&S), the 

Agreement State must promulgate its 

rule to require medical physicists to 

comply with its statute. The commenter 

recommended that the rule text be 

changed to ‘‘allow the individual to 

work under the supervision of an AMP 

as authorized by state laws.’’ 

Response: No change was made to the 

rule text based on this comment. The 

NRC believes that the commenter is 

referring to § 35.433, not § 35.422 (as 

there is no § 35.422 in the regulation). 

The revision of the rule does not 

prohibit a State from requiring the 

‘‘ophthalmic physicist’’ to be licensed 

by the State as long as the licensure 

requirements include components 

essentially identical to NRC T&E 

requirements. The purpose of adding 

the ophthalmic physicist was to identify 

an individual who could assist the 

licensee when the licensee does not 

have access to an AMP. In this situation, 

the ophthalmic physicist cannot work 

under the supervision of an AMP 

because the licensee does not have an 

AMP to perform the activities listed in 

§ 35.433(b). Further, the ophthalmic 

physicist is authorized independently 

and is not required to work under the 

supervision of an AMP. The designation 

‘‘H&S’’ in the summary refers to 

program elements that are not required 

for compatibility, but are identified as 

having a particular health and safety 

significance. The State should adopt the 

essential objectives of such program 

elements in order to maintain an 

adequate program. 

Comment: An Agreement State 

pointed out that its licensure 

requirements for ‘‘Medical Physicist’’ 

are currently consistent with NRC’s 

requirement for an AMP in 10 CFR part 

35. The T&E of the ‘‘ophthalmic 

physicist’’ does not meet its licensure 

requirements and it is unclear whether 

the individual would meet the 

accreditation standards set by the 

American College of Radiology (ACR) or 

the American College of Radiation 

Oncology (ACRO) in radiation oncology, 

which the State requires for manual 

brachytherapy. All state licensees that 

are authorized for possession and use of 

a Sr-90 eye applicator have the services 

of an AMP for other brachytherapy and 

external beam therapy uses. The 

commenter also questioned whether it 

would relieve a shortage of physicists in 

rural areas, because the proposed rule 

does not require an AMP or ophthalmic 

physicist to be physically present at the 

licensee’s authorized location of use, 

with the possible exception of the initial 

source calibration that is performed on 

site or to be on site to perform the decay 

correction and treatment times. The 

commenter concluded that the addition 

of this proposed category of physicist 

did not appear to be applicable in its 

state and therefore should not be 

required for state adoption. The 

commenter proposed that the NRC 

assign Compatibility Category ‘‘B’’ to 

those states that will and category ‘‘D’’ 

to those that will not use the 

designation of ophthalmic physicist. 

Response: No change was made to the 

rule text or to the compatibility category 

designation for the T&E requirements 

for an ophthalmic physicist under 

§ 35.433(a) based on this comment. All 

NRC T&E requirements in 10 CFR part 

35 are designated as Compatibility 

Category B, which means they have 

direct and significant transboundary 

effects. The licensee is required to have 

procedures that specify the frequency at 

which the AMP or ophthalmic physicist 

would observe treatments, review the 

treatment methodology, calculate 

treatment time for the prescribed dose, 

and review records to verify that the 

treatment was in accordance with the 

WD. The individual must be physically 

present at the licensee’s authorized 

location of use on a set frequency to 

complete these tasks. The NRC believes 

that having an individual who is not an 

AMP, but is qualified to perform the 

tasks specified and to perform some of 

them on site, will benefit rural 

licensees. 

Section 35.490 Training for Use of 

Manual Brachytherapy Source 

Comment: One commenter stated that 

the requirements for supervised work 

experience under § 35.490(b)(1)(ii) were 

written vaguely, and that it can and has 

been interpreted as 500 hours of work 

related to radiation therapy, not 

specifically to brachytherapy. The 

commenter believed that this 

interpretation is reasonable, but that it 

would be helpful to have some specific 

brachytherapy related guidance on, e.g., 

the number of cases the proposed AU or 

AMP should observe and/or perform 

under supervision, or the length of time 

they should perform these procedures 

under supervision. 

Response: No change was made to the 

rule text based on this comment. It 

appears that the commenter’s statement 

is limited to the rule text in 

§ 35.490(b)(1)(ii). However, 

§ 35.490(b)(1)(ii) should be taken in the 

context of all of the training 

requirements in § 35.490(b)(1), which 

states, ‘‘Has completed a structured 

educational program in basic 

radionuclide handling techniques 

applicable to the use of manual 

brachytherapy sources that includes [(i) 

and (ii)].’’ Further, the tasks that are to 

be performed under § 35.490(b)(1)(ii) 

include § 35.490(b)(1)(ii)(C): Preparing, 

implanting, and removing 

brachytherapy sources. The NRC does 

not require a minimum number of cases 

because the requirement for a total of 

500 hours of supervised work 

experience, including the tasks required 

under § 35.490(b)(1)(ii)(C), is sufficient 

to ensure the safe use of manual 

brachytherapy sources. 

Section 35.500 Use of Sealed Sources 

and Medical Devices for Diagnosis 

Comment: Several commenters noted 

that NRC’s revision to § 35.500(a) and 

(b) states that ‘‘[a] licensee must only 

use sealed sources or diagnostic devices 

that are approved in the Sealed Source 

and Device Registry . . .’’ and also 

states ‘‘may be used for . . . .’’ One 

commenter stated that these revisions 

contradicted each other, because the 

revision states that the licensee ‘‘must’’ 

for some uses but then uses ‘‘may’’ for 

other uses. Several commenters thought 

this provision put a burden on the SSD 

reviewing agency to ensure that proper 

conditions are included in the SSD 

allowing for other uses. They disagreed 

with the revision and recommended 

that any other uses of these sealed 

sources should be approved by the 

licensing regulatory agency. 

Response: The rule text was modified 

based on these comments. The rule text 


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in § 35.500(a) was changed in order to 

make it clear that it is the sealed 

sources, as opposed to the diagnostic 

medical uses, that must be approved in 

the Sealed Source and Device Registry 

(SSDR). The rule text in § 35.500(b) was 

not changed because the NRC believes 

the language in this section is clear. The 

revision in § 35.500(a) now states, ‘‘A 

licensee must use only sealed sources 

that are not in medical devices for 

diagnostic medical uses if the sealed 

sources are approved in the Sealed 

Source and Device Registry for 

diagnostic medicine. The sealed sources 

may be used for diagnostic medical uses 

that are not explicitly listed in the 

Sealed Source and Device Registry but 

must be used in accordance with the 

radiation safety conditions and 

limitations described in the Sealed 

Source and Device Registry.’’ The 

revision in § 35.500(b) continues to 

state: ‘‘A licensee must only use 

diagnostic devices containing sealed 

sources for diagnostic medical uses if 

both the sealed sources and diagnostic 

devices are approved in the Sealed 

Source and Device Registry for 

diagnostic medical uses. The diagnostic 

medical devices may be used for 

diagnostic medical uses that are not 

explicitly listed in the Sealed Source 

and Device Registry but must be used in 

accordance with the radiation safety 

conditions and limitations described in 

the Sealed Source and Device Registry.’’ 

To clarify, the first part of the 

requirement in each paragraph is to 

restrict the licensee to only use sealed 

sources and devices for diagnostic 

purposes if they are approved for 

diagnostic purposes in the SSDR. The 

purpose of the second part of the 

requirement in each paragraph is to 

allow the licensee the flexibility to use 

diagnostic sealed sources and devices 

for medical uses other than those that 

are explicitly included in the SSDR. As 

long as the limitations and conditions 

included in the SSDR address those 

generally needed for diagnostic uses, 

there is no additional burden on the 

SSD reviewer to revise the SSD for a 

new diagnostic use not explicitly stated. 

If the licensee intends to use a 

diagnostic sealed source or device for a 

non-diagnostic use, then the licensing 

regulatory agency will need to 

determine how to license such use. 

Section 35.600 Use of a Sealed Source 

in a Remote Afterloader Unit, 

Teletherapy Unit, or Gamma 

Stereotactic Radiosurgery Unit 

Comment: Several commenters stated 

that the revision splits the section into 

two paragraphs where (a) is used for 

sources and (b) is used for units. They 

recommend either changing the name of 

the section or adding a new section for 

the units. 

Response: No change was made to the 

rule text based on these comments. The 

current title of the section already 

includes the sealed sources and the 

devices in which the sources are used. 

The requirements in paragraphs (a) and 

(b) parallel this structure. 

Comment: Several commenters 

recommended that § 35.600(b) be 

revised to read: ‘‘A licensee must use 

photon emitting remote afterloader 

units, teletherapy units, or gamma 

stereotactic units: 

i. That are approved in the Sealed 

Source and Device Registry; or 

ii. In research . . . .’’ 

Response: No change was made to the 

rule text based on these comments. The 

purpose of the revisions to § 35.600(b) is 

to clarify that the photon-emitting 

remote afterloader units, teletherapy 

units, or gamma stereotactic units must 

be used in accordance with the 

limitations and considerations of use 

listed in the SSDR and to allow the 

licensee to use the units for medical 

uses not explicitly listed in the SSDR. 

The commenters’ proposed change 

would not address these issues. 

Section 35.610 Safety Procedures and 

Instructions for Remote Afterloader 

Units, Teletherapy Units, and Gamma 

Stereotactic Radiosurgery Units 

Comment: One commenter questioned 

why the revisions to § 35.610(d)(1) 

require training on a new unit to be 

provided only by the vendor or 

individuals certified by the vendor. The 

commenter does not believe there is 

clear evidence that vendor training is 

superior to a course the licensee might 

develop and that the quality of vendor 

training is quite variable. The 

commenter was also concerned that if a 

staff member missed the vendor’s 

training, the licensee would be required 

to make special arrangements, probably 

at considerable cost, to have that person 

trained as required. The commenter 

stated that in most cases the licensee 

will choose to have all staff trained by 

the vendor when a new device is 

installed. The commenter believed that 

licensees should be allowed to provide 

training to their personnel in the 

manner they deem the best as is the case 

today and would be the case at existing 

installations under the proposed rule. 

Response: The rule text was modified 

based on this comment. The rule text 

was changed to clarify that the 

individuals certified by the device 

manufacturer to provide vendor training 

must be specifically certified to provide 

this training. The medical device 

manufacturer is the most knowledgeable 

entity when it comes to its new devices 

or upgrades to devices that affect their 

safety and operation. The NRC’s intent 

is that before the device can be used on 

the first patient, each staff member 

involved in the operation of the device 

for that first patient’s treatment must 

receive training on the operational and 

safety features and procedures from the 

vendor or individuals certified by the 

vendor to provide the training. For 

subsequent patient treatments, the 

requirements in § 35.610(d)(2) apply. 

Comment: One commenter agreed 

that, with respect to the revisions to 

§ 35.610(d)(1), after modifications to the 

unit, staff authorized to use the unit 

needs to be trained on the upgrade and 

how the upgrade affects the operation of 

the unit. The commenter wanted 

clarification on whether ‘‘. . . upgrade 

that affects the operation and safety of 

the unit’’ is meant to cover changes to 

the actual device itself or changes to the 

device and any changes to the treatment 

planning system (software/hardware). 

Response: No change was made to the 

rule text based on this comment. The 

rule covers both software and hardware 

changes that affect the operation and 

safety of the remote afterloader unit, 

teletherapy unit, or gamma stereotactic 

radiosurgery unit. 

Comment: One commenter wanted 

clarification on whether the requirement 

‘‘or by an individual certified by the 

device manufacturer . . .’’ included a 

person at the organization (one of the 

authorized operators) who received the 

device upgrade training from the 

manufacturer and would then be able to 

train all other authorized operators at 

the organization. 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.610(d)(1) was revised to clarify that 

the vendor training can only be 

provided by either the device 

manufacturer or by an individual 

certified by the device manufacturer to 

provide the operational and safety 

training. Therefore, an authorized 

operator at the licensee’s facility that is 

certified by the device manufacturer to 

provide the operational and safety 

training may provide initial instruction 

to other authorized operators at the 

facility. 

Section 35.655 Full-Inspection 

Servicing for Teletherapy and Gamma 

Stereotactic Radiosurgery Units 

Comment: One commenter stated that 

a full inspection is only possible when 

the sources in a gamma stereotactic 

radiosurgery unit are replaced. The 

commenter recommended that the full 


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inspection frequency be revised to occur 

upon source exchange. 

Response: No change was made to the 

rule text based on this comment. The 

NRC agrees that the full inspection is 

only possible when the sources in a 

gamma stereotactic radiosurgery unit are 

replaced. Further, the NRC believes that 

the source replacement interval for a 

gamma stereotactic radiosurgery unit 

can be extended to 7 years because of 

the 6-month routine preventive 

maintenance performed on these units. 

Section 35.690 Training for Use of 

Remote Afterloader Units, Teletherapy 

Units, and Gamma Stereotactic 

Radiosurgery Units 

Comment: One commenter stated that 

it was unclear how an individual who 

is board certified but beyond 7 years of 

the required training may seek AU or 

AMP status. The commenter believed 

that, for safety, there should be some 

minimum number of cases the 

individual must observe prior to 

obtaining AU or AMP status especially 

in light of the complexity of interstitial 

procedures such as LDR or HDR 

prostate. 

Response: No change was made to the 

rule text based on this comment. The 

NRC reviews, on a case by-case basis, 

each applicant who received board 

certification more than 7 years ago and 

requests to be authorized as an AU or 

AMP. The licensee must demonstrate 

that the individual has had related 

continuing education and experience 

since the required training was 

completed. Because of the rigorous T&E 

requirements already in place, the NRC 

has not set a minimum number of cases 

a physician or a medical physicist must 

observe prior to obtaining AU or AMP 

status. 

Comment: One commenter stated that 

replacing ‘‘institution’’ in 

§ 35.690(b)(1)(ii) with ‘‘facility that is 

authorized to use byproduct material in 

35.600’’ may cause difficulties without 

any apparent benefit. Under current 

regulations, a residency program at an 

institution that has only linear 

accelerators can provide some of the 

work experience pertinent to the 

requirements at its institution so long as 

it has the appropriate AUs on staff 

(which is common with physician 

faculty practicing at affiliated outpatient 

facilities). While residents need some 

direct work experience with, for 

example, treatment planning for HDR 

after loaders, there are concepts learned 

in a linear accelerator treatment 

planning that apply. This is especially 

true of external beam therapy from 

radioactive sources. Therefore, if a 

preceptor judges it to be appropriate, an 

individual should be allowed to acquire 

a portion of the required 500 hours of 

work experience at a facility that does 

not use byproduct material in § 35.600. 

Response: No change was made to the 

rule text based on this comment. The 

amendment the commenter described 

was made to ensure that the supervised 

work experience was obtained at a 

medical facility (including a stand-alone 

single discipline clinic) where the 

facility is authorized for uses under 

§ 35.600. Section 35.690 also includes a 

requirement that the individual 

complete a 3-year accredited residency 

program in radiation therapy. This 

residency program is not restricted to a 

facility that is authorized for § 35.600 

uses. The NRC recognizes that the 

‘‘concepts learned’’ that the commenter 

referred to may be obtained from such 

a facility but that the individual still 

needs 500 hours of supervised work 

experience with the § 35.600 devices. 

Comment: One commenter expressed 

concern regarding whether a residency 

program approved by the Royal College 

of Physicians and Surgeons of Canada 

can be used to meet the requirements in 

§ 35.690(b)(2) because of the specific 

mention of a medical facility authorized 

to use byproduct material in § 35.600. 

Currently, the NRC’s, ‘‘Procedures for 

Recognition of Foreign Trained 

Physicians and Physicists Applying for 

Authorized User (AU) and Authorized 

Medical Physicist (AMP) Status,’’ states 

that a physician coming out of a 

residency approved by the Royal 

College of Physicians and Surgeons of 

Canada would need to work under a 

physician who also practices in the 

United States. While such physicians 

likely exist, adding the additional 

requirement that the facility is 

authorized to use byproduct material in 

§ 35.600 appears to add an additional 

hurdle to allowing hours from these 

residencies. 

Response: No change was made to the 

rule text based on this comment. The 

commenter is correct that a physician 

completing a residency program 

approved by the Royal College of 

Physicians and Surgeons of Canada may 

have to complete his or her 500 hours 

of supervised work experience at 

another facility that is authorized for 

uses under § 35.600. 

Section 35.3045 Report and 

Notification of a Medical Event 

The NRC received many comments on 

various issues related to the permanent 

brachytherapy event reporting criteria 

under this section. For better 

understanding of the concerned raised, 

the comments are grouped according to 

the distinct issues commenters raised. 

Issue: The Medical Event Reporting 

Criterion Are Based on the Term 

‘‘Potential Harm’’ 

Comment: Several commenters stated 

that they do not agree with the use of 

the term ‘‘potential harm’’ in the 

discussion of MEs in the Federal 

Register notice for the proposed rule. 

The commenters believe that ‘‘potential 

harm’’ is a medical decision and that 

this approach is a significant departure 

from the current definition of an ME. 

The commenters believe that this 

approach will eliminate the opportunity 

for licensees to identify precursor events 

and make process improvements, and 

that it could have the unintended 

consequence of providing additional 

support for malpractice suits. In 

articulating their objection to NRC’s 

position, some commenters stated that 

‘‘[a]s regulators, we are not tasked for 

determining what the ‘potential harm’ 

is, our mission is to ensure licensees 

abide by the required regulations.’’ 

Response: The NRC believes that the 

rule will not discourage licensees from 

identifying precursor events or making 

process improvements. The rule 

continues to reflect the NRC’s position 

that an ME may be indicative of 

potential problems in a medical 

facility’s use of radioactive materials 

and does not necessarily result in harm 

to the patient. This position is based on 

the NRC staff recommendations 

submitted to the Commission in SECY– 

05–0234, ‘‘Adequacy of Medical Event 

Definitions in § 35.3045, and 

Communicating Associated Risks to the 

Public,’’ dated December 27, 2005. The 

NRC staff recommendations were 

approved by the Commission in SRM to 

SECY–05–0234, dated February 15, 

2006. The ME criteria for permanent 

implant brachytherapy are now 

consistent with the criteria for other 

therapeutic modalities by reflecting 

circumstances in which there may be 

harm or potential harm to the patient. 

Issue: The Medical Event Reporting 

Criterion Related to the Absorbed Dose 

to Normal Tissues Located Within the 

Treatment Site 

Comment: One commenter had 

questions and expressed concerns about 

the ME reporting criterion in § 35.3045 

related to ‘‘intra-target’’ normal tissue. 

The commenter stated that for prostate 

implants the urethra is the only such 

structure to consider, and the volume is 

much less than 5 cubic centimeters. The 

commenter wanted to know whether, if 

the dose threshold for reporting an ME 

was exceeded for the urethra, given that 

the volume is less than 5 cubic 

centimeters, if that instance would 


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require reporting. The commenter also 

expressed concern that treatment 

planning systems could not distinguish 

between a 5 cubic centimeters volume 

and a summation of five 1 cubic 

centimeters volumes receiving 150 

percent of the prescribed dose. 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iv), which would have 

required the assessment of the absorbed 

dose to normal tissue within the 

treatment site. The NRC understands 

that the volume of the urethra within 

the treatment site is typically less than 

5 cubic centimeters. In addition, the 

NRC acknowledges the commenter’s 

concern that treatment planning systems 

may not distinguish contiguous volumes 

from non-contiguous, summated 

volumes. In response to this concern 

and those raised by other commenters, 

the NRC removed the absorbed dosebased ME reporting criterion in 

§ 35.3045(a)(2)(iv). 

Comment: One commenter expressed 

concerns about the absorbed dose-based 

criterion for normal tissue within the 

treatment site and stated that it is 

common for 50 percent or more of the 

treatment site to receive a dose that 

exceeds the prescribed dose by greater 

than 50 percent. The commenter was 

concerned that quality implants may be 

categorized as MEs using this criterion. 

The commenter also stated that its 

vendor’s software does not provide a 

method to evaluate dose to contiguous 

volumes of tissue within the treatment 

site. 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iv), which would have 

required the assessment of the absorbed 

dose to normal tissue within the 

treatment site. The NRC agrees that 

quality implants may be categorized as 

MEs if 50 percent or more of the 

treatment site intentionally receives a 

dose that exceeds the prescribed dose by 

greater than 50 percent. The NRC 

understands that some treatment 

planning software may be unable to 

distinguish contiguous volumes of 

tissue. In response to this concern and 

those raised by other commenters, the 

NRC removed the absorbed dose-based 

ME reporting criterion in 

§ 35.3045(a)(2)(iv). 

Comment: One commenter expressed 

concerns about the ME reporting 

criterion in § 35.3045(a)(2)(iv). The 

commenter stated that, using this 

criterion, it would be difficult for 

licensees to determine if an ME had 

occurred and nearly impossible for 

regulators to independently determine if 

a licensee is appropriately classifying 

and reporting MEs. 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iv), which would have 

required the assessment of the absorbed 

dose to normal tissue within the 

treatment site. The NRC understands 

that it may be difficult for licensees and 

regulators to determine if an ME 

occurred under this criterion. In 

response to this concern and those 

raised by other commenters, the NRC 

removed the absorbed dose-based ME 

reporting criterion in § 35.3045(a)(2)(iv). 

Comment: One commenter expressed 

concerns about the ME reporting 

criterion in § 35.3045 related to the 

normal tissue located within the 

treatment site. The commenter stated 

that the normal tissue within the 

treatment site for prostate implants is 

the urethra and it is necessary to place 

a catheter in the urethra to assess dose 

to this tissue. The commenter noted that 

licensees may not routinely catheterize 

the patient during post-implantation 

imaging; therefore, they do not have the 

imaging information necessary to assess 

urethral dose. The commenter further 

stated that pre-implantation images 

performed on catheterized patients 

show that the urethral volume is 

typically 1 cubic centimeter or less. The 

commenter concluded that an ME 

would never be found for normal 

urethral tissue for a prostate implant 

because there is not 5 cubic centimeters 

of contiguous urethral tissue within the 

treatment site. 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iv), which would have 

required the assessment of the absorbed 

dose to the maximally exposed 5 

contiguous cubic centimeters of normal 

tissue within the treatment site. The 

NRC understands that licensees may not 

routinely acquire the imaging 

information necessary to assess postimplantation urethral dose. The NRC 

also understands that the urethral 

volume within the treatment site is 

typically considerably less than 5 cubic 

centimeters, and as a result it is unlikely 

that an ME would occur using the 

proposed criterion. 

Comment: One commenter stated that 

using absorbed dose-based criteria may 

limit the licensee’s ability to determine 

if an ME has occurred when evaluating 

dose to normal structures located within 

the treatment site that are even more 

difficult to contour than the prostate. 

The commenter suggested removing the 

use of absorbed dose-based criterion for 

normal tissue within the treatment site. 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iv), which would have 

required the assessment of the absorbed 

dose to normal tissue within the 

treatment site. The NRC agrees with the 

commenter’s suggestion and in response 

to this concern and those raised by other 

commenters, the NRC removed the use 

of absorbed dose-based criteria for 

reporting MEs in § 35.3045(a)(2)(iv). 

Comment: One commenter expressed 

concern about the ME reporting 

criterion in § 35.3045(a)(2)(iv) related to 

the absorbed dose to normal tissue 

located within the treatment site. The 

commenter stated that ‘‘precise control 

of source location inside the treatment 

site over several half-lives is impossible 

(and not necessary), so absorbed dose to 

intra-target structures is impossible to 

control.’’ The commenter believes this is 

a medical decision, not a suitable ME 

criterion. The commenter stated 

‘‘[m]edicine has to operate in a riskbenefit balance when it comes to normal 

tissues, so the NRC has no role here.’’ 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iv), which would have 

required the assessment of the absorbed 

dose to normal tissue within the 

treatment site. The NRC acknowledges 

the commenter’s concern that absorbed 

dose to intra-target structures is 

impossible to control and is a medical 

decision. In response to this concern 

and those raised by other commenters, 

the NRC removed the dose-based ME 

reporting criterion in § 35.3045(a)(2)(iv). 

Comment: One commenter stated that 

‘‘[i]dentification of normal tissue in the 

treatment volume (urethra) [during a 

prostate implant procedure] is difficult 

if not impossible with a CT scan.’’ The 

commenter also stated that the radiation 

dose is variable across the treatment site 

and therefore the ‘‘determination’’ of the 

dose to the normal tissue within the 

treatment site is ‘‘ambiguous.’’ The 

commenter further stated that ‘‘[t]he 

only way to clearly define the urethra 

during the post Dosimetry CT scan 

would be to catheterize the patient, 

which would cause significant pain to 

the patient, and therefore is not 

performed.’’ 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iv), which would have 

required the assessment of the absorbed 

dose to normal tissue within the 

treatment site. The NRC acknowledges 

the commenter’s concerns related to 

difficulties associated with imaging the 

urethra and estimating the dose to it. In 


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response to these concerns and those 

raised by other commenters, the NRC 

removed the absorbed dose-based ME 

reporting criterion in § 35.3045(a)(2)(iv). 

Comment: One commenter expressed 

difficulty in understanding how clinics 

that use a nomogram-based approach to 

‘‘pre-planning,’’ where there is no preimplant dose distribution, would 

evaluate the ME definition for ‘‘intratarget normal structures’’ in 

§ 35.3045(a)(2)(iv). 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iv), which would have 

required the assessment of the absorbed 

dose to normal tissue within the 

treatment site. The NRC understands the 

commenter’s concern that clinics that 

use a nomogram-based approach to 

‘‘pre-planning,’’ where there is no preimplant dose distribution, may have 

difficulty in evaluating the dose to 

normal tissue within the treatment site 

under the proposed ME definition. In 

response to this concern and those 

raised by other commenters, the NRC 

removed the absorbed dose-based ME 

reporting criterion in § 35.3045(a)(2)(iv). 

Issue: The Medical Event Reporting 

Criterion in § 35.3045 Related to the 

Absorbed Dose to Normal Tissues 

Located Outside the Treatment Site 

Comment: One commenter expressed 

concerns about the ME reporting 

criterion in § 35.3045(a)(2)(iii) related to 

the absorbed dose to normal tissue 

located outside the treatment site. The 

commenter stated that their treatment 

planning software does not have an 

automated method for determining the 

volume of normal tissue that exceeds 

the prescribed dose by 50 percent. They 

stated that a manual method for making 

such a determination would lead to 

different results depending on who 

contours the normal tissue volume 

being assessed. The commenter also 

noted that the definition of ‘‘contiguous 

normal tissue’’ is not clear. 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iii), which would have 

required the assessment of the absorbed 

dose to normal tissue outside the 

treatment site. The NRC acknowledges 

the commenter’s concern that some 

treatment planning software may is not 

capable of automatically determining 

the volume of normal tissue that 

exceeds the prescribed dose by 50 

percent. In response to this concern and 

those raised by other commenters, the 

NRC removed the absorbed dose-based 

ME reporting criterion in 

§ 35.3045(a)(2)(iii). 

Comment: Two commenters 

expressed concerns about the 

requirement to evaluate and determine 

the absorbed dose to the maximally 

exposed 5 contiguous cubic centimeters 

of normal tissue ‘‘around’’ the treatment 

site. The commenters further stated that 

these proposed ME reporting criteria are 

not consistent with current medical 

practice and may discourage licensees 

from performing permanent 

brachytherapy, which would deny 

patients access to this technology. 

Response: The rule text was modified 

based on these comments. The rule text 

in § 35.3045(a)(2) was modified to 

remove § 35.3045(a)(2)(iii) and (iv), 

which would have required the 

assessment of the absorbed dose to the 

maximally exposed 5 contiguous cubic 

centimeters of normal tissue outside and 

within the treatment site. The NRC 

acknowledges the commenters’ concern 

that the proposed rule text is not 

consistent with current medical practice 

and may discourage some licensees 

from performing permanent 

brachytherapy. In response to this 

concern and those raised by other 

commenters, the NRC removed the 

absorbed dose-based ME reporting 

criterion in § 35.3045(a)(2)(iii) and (iv). 

Comment: Two commenters 

expressed concerns about the use of 

absorbed dose to 5 contiguous cubic 

centimeters as a criterion for reporting 

MEs. The commenters noted that the 

absorbed dose to 5 contiguous cubic 

centimeters was proposed as a guideline 

for treating cancer of the cervix in a 

single journal article published 10 years 

ago. The commenters also pointed out 

that these guidelines were proposed ‘‘for 

research purposes,’’ reflected the 

personal opinions of the authors, and 

were not endorsed or adopted by any of 

the radiation oncology professional 

organizations. The commenters 

requested that the NRC provide further 

justification for establishing a 5 

contiguous cubic centimeters regulatory 

standard. 

Response: The rule text was modified 

based on these comments. The rule text 

in § 35.3045(a)(2) was modified to 

remove § 35.3045(a)(2)(iii) and (iv), 

which would have required the 

assessment of the absorbed dose to the 

maximally exposed 5 contiguous cubic 

centimeters of normal tissue outside and 

within the treatment site. The NRC 

included these requirements in the 

proposed rule based on a 

recommendation from the ACMUI. 

However, based on these and other 

comments, the NRC concluded that 

absorbed dose to 5 contiguous cubic 

centimeters is not a suitable criterion for 

reporting MEs. Therefore, the NRC 

removed subparagraphs (iii) and (iv), 

which would have required licensees to 

use absorbed dose criteria to report MEs 

for permanent brachytherapy. 

Comment: One commenter stated that 

the volume for determining an absorbed 

dose to normal tissue for compliance 

with the reporting requirements in 

§ 35.3045 is not clearly defined. The 

commenter noted that it appears 

reasonable in theory to determine 

absorbed dose to the maximally exposed 

5 contiguous centimeters of normal 

tissue. However, the commenter 

believes that it will be difficult to make 

this determination using current 

technology. The commenter stated that 

‘‘planning systems typically report dose 

volume histograms to structures, but 

they do not identify contiguous 

volumes.’’ 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iii) and (iv), which 

would have required the assessment of 

the absorbed dose to normal tissue 

outside and within the treatment site. 

The NRC acknowledges that while some 

treatment planning systems can identify 

contiguous volumes, others cannot. In 

response to this concern and those 

raised by other commenters, the NRC 

removed the absorbed dose-based ME 

reporting criterion in § 35.3045(a)(2)(iii) 

and (iv). 

Comment: One commenter stated that 

the requirement in § 35.3045(a)(2)(iii) 

(absorbed dose to the maximally 

exposed 5 contiguous centimeters of 

normal tissue located outside of the 

treatment site) will be difficult to 

implement. The commenter stated that 

treatment planning systems report dosevolume histograms to structures but do 

not identify contiguous volumes. The 

commenter also stated that the term 

‘‘treatment site’’ is not well defined. The 

commenter used the prostate as an 

example and pointed out that some 

licensees identify the prostate as the 

treatment site and develop the treatment 

plan with a particular margin of normal 

tissue around it, while others include a 

PTV (planning treatment volume) 

around the prostate and plan for that 

volume. The commenter explained that 

seeds may be placed in interstitial tissue 

outside the prostate to ensure adequate 

dose is delivered to the prostate. The 

commenter expressed concern that ‘‘[i]f 

the normal tissue involved interstitial 

tissue, it would not cause a medically 

significant event to the patient.’’ 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iii), which would have 

required the assessment of the absorbed 


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dose to normal tissue outside the 

treatment site. The NRC acknowledges 

the commenter’s concern that some 

treatment planning software may be 

unable to automatically determine the 

volume of normal tissue that exceeds 

the prescribed dose by 50 percent. The 

NRC also acknowledges that AUs 

describe ‘‘treatment site’’ in different 

ways. The NRC expects the AU to 

describe the treatment site (as defined in 

§ 35.2) in the WD in any way he or she 

believes to be medically appropriate. In 

response to these concerns and those 

raised by other commenters, the NRC 

removed the absorbed dose-based ME 

reporting criterion in § 35.3045(a)(2)(iii). 

Issue: Source-Strength-Based Criteria as 

the Metric for Permanent Brachytherapy 

Versus Absorbed Dose-Based Criteria 

Comment: Two commenters stated 

that the use of source-strength based 

criteria as the metric for permanent 

brachytherapy is directly proportional 

to the absorbed dose, and consistent 

with nuclear medicine administrations 

of radiopharmaceutical therapy whose 

purpose is to achieve a prescribed tumor 

dose. The commenters also pointed out 

that dose is not factored into the ME 

definition for radiopharmaceuticals, and 

has been an auditable measure by 

inspectors since the definition of 

‘‘misadministration’’ that was created 

decades ago. 

Response: The rule text was modified 

based on this and other comments. 

While the NRC agrees that source 

strength is a major factor impacting 

absorbed dose for permanent 

brachytherapy, the absorbed dose is 

determined by a combination of source 

strength and spatial positioning. Despite 

this fact, in response to this comment 

and different concerns raised by other 

commenters, the NRC determined that a 

source-strength based criterion is 

appropriate to define MEs for 

permanent implant brachytherapy and 

removed the absorbed dose-based ME 

reporting criterion in § 35.3045(a)(2)(iii) 

and (iv). 

Issue: Require Licensees To Establish 

Certain Documented Criteria for a 

Medically Acceptable Implant Instead of 

the Absorbed Dose to Normal Tissues 

Comment: Two commenters suggested 

the modification of § 35.3045(a)(2) to 

remove both criteria for absorbed dose 

to 5 contiguous centimeters of tissue 

and require instead that licensees 

establish documented criteria such as 

D90 or V100 that provide for a 

medically acceptable permanent 

implant. 

Response: The rule text was modified 

based on other comments. The rule text 

in § 35.3045(a)(2) was modified to 

remove § 35.3045(a)(2)(iii) and (iv), 

which would have required the 

assessment of the absorbed dose to the 

maximally exposed 5 contiguous cubic 

centimeters of normal tissue outside and 

within the treatment site. The NRC 

agrees with removing the proposed 

absorbed dose-based criteria for 

reporting MEs for normal tissue. 

However, the NRC is not changing the 

rule text to require licensees to establish 

documented dose-based criteria such as 

D90 or V100 that would provide for a 

medically acceptable implant, as 

suggested by the commenter. The term 

‘‘D90’’ is the dose reported in Gray or 

as a percentage of the prescribed dose 

that covers 90 percent of the target 

volume. The term ‘‘V100’’ is the 

fractional volume of the target usually 

reported as a percentage that receives 

100 percent of the prescribed dose. The 

effect of making the commenter’s 

proposed change would be a 

requirement to report as an ME under 

§ 35.3045(a)(2) any permanent implant 

that is not deemed medically 

acceptable. The NRC believes that such 

a requirement could risk interfering 

with the practice of medicine. The NRC 

determined, for reasons explained in 

response to other comments, that the 

dose-based criteria should be removed 

and not replaced. 

Issue: Sealed Source(s) Directly 

Delivered to the Wrong Treatment Site 

Comment: Several commenters 

expressed concern with the proposed 

rule text in § 35.3045(a)(2)(v)(C), which 

requires reporting sealed source(s) 

directly delivered to the wrong 

treatment site as an ME. Two 

commenters specifically pointed out 

that § 35.3045(a)(2)(v)(C) is in direct 

conflict with § 35.3045(a)(2)(ii), which 

allows for 20 percent of the implanted 

source activity to be outside of the 

intended treatment site. Further, the 

commenters pointed out that, as 

proposed, this section would require 

that even a single sealed source directly 

delivered to the wrong treatment site be 

reported as an ME. Several commenters 

pointed out that when performing a 

normal implant procedure, sources can 

occasionally be deposited outside the 

treatment site due to various factors 

such as uncertainties in intraoperative 

imaging, patient motion, suction of 

seeds due to needle withdrawal, or seed 

migration. For example, one commenter 

stated that because in a prostate implant 

90 to 100 seeds are routinely implanted, 

‘‘[a] seed could end up in tissue 

surrounding the prostate, in the bladder, 

or in the rectum. The overall impact 

would be numerous MEs of no clinical 

significance reported.’’ Other 

commenters stated that source(s) 

implanted directly into the wrong site or 

body part, e.g., if the right breast was 

implanted when the left breast was 

intended to be implanted, should 

constitute a reportable ME. One 

commenter suggested that the NRC 

establish a reasonable de minimis 

threshold. Several commenters 

suggested revising § 35.3045(a)(2)(v)(C) 

to require that ‘‘sealed source(s) directly 

delivered to a ‘‘non-contiguous’’ wrong 

treatment site’’ be reported as MEs. 

Response: The rule text was modified 

based on these comments and a 

recommendation from the ACMUI. The 

NRC agrees that typical permanent 

implant procedures result in some 

sources being implanted outside the 

treatment site as described in the WD. 

In accordance with § 35.3045(a)(2)(ii), 

an ME has not occurred when less than 

20 percent of the sources are implanted 

outside the treatment site. The NRC also 

agrees that § 35.3045(a)(2)(v)(C), as 

proposed [now § 35.3045(a)(2)(iii)(C)], 

appears to be in conflict with the 

provisions of § 35.3045(a)(2)(ii). To 

ensure that the provisions of 

§ 35.3045(a)(2)(iii)(C) can be 

distinguished from those in 

§ 35.3045(a)(2)(ii), the NRC has changed 

§ 35.3045(a)(2)(iii)(C) to read: ‘‘Sealed 

source(s) implanted directly into a 

location discontiguous from the 

treatment site, as documented in the 

post-implantation portion of the WD.’’ 

Issue: Sources That Were Implanted in 

the Correct Site but Migrated Outside 

the Treatment Site 

Comment: Several commenters noted 

that § 35.3045(a)(3) currently includes 

the phrase, ‘‘excluding, for permanent 

implants, seeds that were implanted in 

the correct site but migrated outside the 

treatment site’’ but that this provision 

was not included in the proposed rule. 

They said that removal of this provision 

‘‘will cause numerous spurious reported 

MEs which will be unnecessarily 

burdensome and time consuming to the 

NRC and the licensee without 

increasing patient safety.’’ One 

commenter stated that migration of 

seeds from a prostate treatment site is a 

potential clinical occurrence. The 

commenters asked the NRC to restore 

the provision for migrated seeds. 

One commenter expressed concern 

that failure to include an exclusion for 

migrated sources would require 

reporting as ME permanent implant 

brachytherapy procedures in which the 

sources were placed correctly then 

migrated. The commenter suggested that 

‘‘. . . images taken 15, or 30, or 60 days 

after an implant cannot unambiguously 


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determine the placement of sources at 

the time of implant. Only placement 

meeting Medical Event criteria in 

§ 35.3045(a)(2) at time of implant should 

constitute a Medical Event.’’ The 

commenter also stated that some 

licensees do not offer permanent 

brachytherapy because of a concern that 

MEs could occur due to circumstances 

beyond their control, and the damage 

that can result from the publicity 

surrounding an ME. 

One commenter noted that in the 

2002 revisions to 10 CFR part 35, the 

term ‘‘recordable event’’ was eliminated 

and the term ‘‘misadministration’’ was 

changed to ‘‘medical event.’’ The 

commenter stated that the definition (of 

an ME) did not change. The definition 

compares the treatment administered to 

what the AU intended to administer. 

The commenter expressed concern that, 

as proposed, a treatment could be 

identified as an ME if the seeds moved 

after they were implanted correctly. The 

commenter stated that the proposed rule 

as written may inhibit a physician from 

helping a patient if migration of seeds 

is not taken into account in defining an 

ME for permanent implant 

brachytherapy implants. 

Response: The rule text was modified 

based on these comments. The rule text 

in § 35.3045(a)(2) was modified to 

restore the provision for sources that 

were implanted in the correct site but 

migrated outside the treatment site. The 

NRC agrees that migration of sources 

that were implanted in the correct site 

should not be considered an ME. 

Comment: One commenter expressed 

concern about the phrase ‘‘outside of the 

treatment site’’ at § 35.3045(a)(2)(ii). 

This is the proposed criterion to define 

as an ME a permanent implant 

brachytherapy administration that 

results in the total source strength 

administered outside of the treatment 

site exceeding 20 percent of the source 

strength documented in the postadministration WD. The commenter 

noted that, for permanent prostate 

implants, most of the seeds are 

purposely implanted in and around the 

periphery of the gland and many can 

drift. The commenter stated that 20 

percent of the sources may drift, even 

when linked together, and asked if the 

NRC has established a cutoff distance 

for drift. The commenter also expressed 

concern about the statement that if even 

one source is apparently ‘‘directly 

implanted . . . into another (distant 

from the treatment site) location,’’ it is 

an ME, and noted that it may be difficult 

to distinguish a seed that drifted a long 

distance from one that was directly 

implanted into a location distant from 

the treatment site. The commenter 

believes that these questions will force 

AUs to define a treatment site ‘‘with 

huge margins for seed drift.’’ 

The commenter also asked what rule 

would apply if all seeds are in the 

treatment site, but ‘‘badly distributed 

around the periphery.’’ The commenter 

stated that this could result in a ‘‘bad 

cold spot’’ in the treatment site dose 

distribution and noted that many 

permanent prostate implants ‘‘show this 

tendency naturally 30 days after 

implant.’’ 

The commenter stated that these 

issues pertain to the practice of 

medicine and should not be regulated 

by the NRC. 

Response: No change was made to the 

rule text based on this comment. The 

NRC has not established a cutoff 

distance for ‘‘drift’’ or source migration. 

The AU defines the treatment site in the 

WD in any way he or she believes to be 

medically appropriate, including any 

margins. The NRC agrees that migration 

of sources that were implanted into the 

correct site should not be considered an 

ME. In response to other comments, the 

rule text at § 35.3045(a)(2) was changed 

to restore the exclusion to ME reporting 

requirements for sources that were 

implanted in the correct site but 

migrated outside the treatment site. In 

response to other comments, the rule 

text at § 35.3045(a)(2)(v)(C) [now 

§ 35.3045(a)(2)(iii)(C)] was also changed 

to replace the phrase ‘‘[s]ealed source(s) 

directly delivered into the wrong 

treatment site’’ with ‘‘[s]ealed source(s) 

implanted directly into a location 

discontiguous from the treatment site, as 

documented in the post-implantation 

portion of the written directive.’’ 

The NRC agrees that the dose 

distribution within the treatment site is 

not a suitable ME criterion because it 

can vary over time and is not fully 

under the control of the AU. In response 

to other comments, the NRC revised the 

permanent implant brachytherapy ME 

criteria at § 35.3045(a)(2) to be based 

only on total source strength, not dose. 

As a result, no ME has occurred if at 

least 80 percent of the sources are in the 

treatment site, regardless of the 

distribution of the sources or the 

existence of a ‘‘cold spot’’ in the dose 

distribution. The NRC agrees, and it is 

the NRC policy, that the NRC should not 

(and does not) regulate the practice of 

medicine. 

Issue: Medical Event Definition Should 

Allow an Exception for Causes Outside 

of the Physician’s Control 

Comment: One commenter suggested 

that the ME definition should allow 

exceptions for patient-related and 

procedure-related causes (other than 

seed migration) that are outside of the 

physician’s control. The commenter 

noted that the exception for MEs 

resulting from patient intervention does 

not address procedure-related causes 

that are outside of the physician’s 

control. The commenter recommended 

that § 35.3045(a)(2) be revised to read: 

‘‘For permanent implant brachytherapy, 

the administration of byproduct 

material or radiation from byproduct 

material (not resulting from patientrelated or procedure-related causes— 

such as edema, source migration after 

placement or imaging uncertainties) that 

results in . . .’’ The commenter 

expressed concern that, without an 

exception for patient-related and 

procedure-related causes, ‘‘many 

medically acceptable procedures will be 

labeled as MEs, contrary to our 

understanding of the NRC’s intent.’’ 

Response: No change was made to the 

rule text based on this comment. The 

NRC did not modify the rule to include 

exceptions for patient-related and 

procedure-related causes (other than 

seed migration) that are outside of the 

physician’s control. Factors outside of 

the physician’s control, such as edema 

and imaging uncertainties, should have 

limited impact under the sourcestrength based ME reporting criteria in 

§ 35.3045(a)(2)(ii). 

Issue: Error in Calculating the Total 

Source Strength 

Comment: One commenter stated that 

it is not clear why the ME criterion in 

§ 35.3045(a)(2)(v)(E), i.e., ‘‘[a] 20 percent 

or more error in calculating the total 

source strength documented in the preimplantation portion of the written 

directive,’’ was proposed. The 

commenter believes that this criterion 

was based on an ‘‘ACMUI proposal of 

using the wrong activity or source 

strength (+ /¥20 percent) as specified in 

the written directive,’’ and noted that 

the ACMUI did not specify whether this 

is ‘‘wrong’’ as compared to the preimplantation or post-implantation 

portion of the WD. The commenter 

stated that the requirement in 

§ 35.3045(a)(2)(v)(E) appears to be a 

duplication of the intent of 

§ 35.3045(a)(2)(i) and recommended 

deleting § 35.3045(a)(2)(v)(E). 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2)(v) was revised to delete 

the ME criterion described in 

§ 35.3045(a)(2)(v)(E), ‘‘[a] 20 percent or 

more error in calculating the total 

source strength documented in the preimplantation portion of the written 

directive.’’ However, the NRC 

determined that § 35.3045(a)(2)(v)(E) 

was not a duplication of 


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§ 35.3045(a)(2)(i), but agrees that the 

provision is not needed. As stated by 

the commenter, this criterion was 

originally recommended by the ACMUI. 

In July 2005, the ACMUI submitted to 

the NRC a set of guiding principles to 

assist the NRC staff in defining a rule to 

capture MEs from permanent implant 

brachytherapy procedures. One of the 

principles recommended a limited dosebased ME criterion: ‘‘[a]n implant is a 

medical event if the dose calculations 

used to determine the total source 

strength documented in the written 

directive are in error by more than 20 

percent in either direction.’’ The 

ACMUI explained that this ‘‘limited’’ 

ME dose pathway would ‘‘focus only on 

preplanning or intraoperative planning, 

not post-implant evaluation.’’ Because 

the revised ME criteria are based on 

post-implant evaluations, the NRC 

agrees that the criterion at 

§ 35.3045(a)(2)(v)(E) is not needed. 

Comment: One commenter stated that 

the criterion in § 35.3045(a)(2)(i) is 

consistent with clinically relevant 

circumstances. The commenter 

expressed concern that this is exactly 

the same as the requirement in 

§ 35.3045(a)(2)(v)(E). The commenter 

noted that the rationale is unclear for 

comparing against the post-implantation 

source strength in § 35.3045(a)(2)(i) and 

comparing against the pre-implantation 

source strength in § 35.3045(a)(2)(v)(E). 

The commenter also stated that current 

practice is ‘‘to assay a portion of the 

seeds to ensure the total source strength 

is as ordered, which would prevent both 

of these medical events from occurring.’’ 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2)(v) was revised to delete 

the ME criterion in § 35.3045(a)(2)(v)(E) 

of the proposed rule: ‘‘[a] 20 percent or 

more error in calculating the total 

source strength documented in the preimplantation portion of the written 

directive.’’ Although these criteria are 

not exactly the same, the NRC agrees 

with the commenter that the criterion at 

§ 35.3045(a)(2)(v)(E) is not needed 

because such situations will almost 

always be captured by the criteria at 

§ 35.3045(a)(2)(i) and (a)(2)(ii). In the 

rare situation where a calculation error 

would not be captured by the criteria at 

(a)(2)(i) or (a)(2)(ii)—for example, 

because the calculation error was later 

corrected—then the NRC would not 

deem it appropriate to report the 

calculation error itself as an ME. 

The NRC considered the commenter’s 

statement that these types of MEs would 

be prevented by assaying a portion of 

the seeds to ensure the total source 

strength is as ordered and concluded 

that this may not be fully correct. For 

example, it is possible for an ME to 

occur if there was an error of 20 percent 

or more in the total source strength 

ordered and administered. 

Issue: Comparison of Source Strength 

Specified in the Pre-Implantation 

Written Directive 

Comment: Several commenters stated 

that ME reporting for permanent 

implant brachytherapy must be based 

on the source strength in the postadministration WD as described in 

§ 35.40(b)(6)(ii). Some of the 

commenters stated that the proposed 

changes to § 35.3045 wrongly specified 

the pre-implantation WD. 

Response: No changes were made in 

response to these comments. The source 

strength comparisons for the ME 

reporting criteria in § 35.3045(a)(2)(i) 

and (ii) are with the source strength 

specified in the post-implantation WD. 

Although § 35.3045(a)(2)(iii) of the 

proposed rule included an absorbed 

dose comparison with information in 

the pre-implantation WD, the NRC 

removed this criterion in response to 

other comments. Also, 

§ 35.3045(a)(2)(v)(E) of the proposed 

rule included a calculated total source 

strength with the pre-implantation WD, 

but NRC removed this criterion in 

response to different comments. As a 

result, § 35.3045(a)(2) no longer requires 

any comparisons with the preimplantation WD. 

Issue: Support Source Strength-Only 

Approach for Medical Event Criteria for 

Permanent Implants 

Comment: One commenter supported 

the shift to use total source strength 

administered (activity-based) ME 

criteria for permanent implants rather 

than dose delivered (dose-based) criteria 

for permanent brachytherapy implants. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter expressed 

several concerns related to the proposed 

dose-based portion of the criteria for 

permanent implant brachytherapy ME 

reporting. The commenter 

recommended that any ME reporting for 

permanent implant brachytherapy be 

based solely on a source-strength based 

definition for the WD as recommended 

originally by the ACMUI and the 

radiological societies rather than the 

proposed hybrid definition based on 

source strength and absorbed dose. The 

commenter’s concerns included: (1) 

That the WD has no absorbed dose 

specification; (2) that regulatory 

inspectors do not possess the expertise 

to assess permanent seed implants and 

determine if any 5 contiguous cubic 

centimeters have exceeded an expected 

absorbed dose by 50 percent; (3) that 

different licensees use different 

absorbed dose metrics to determine a 

successful implant; (4) that the dose to 

5 contiguous cubic centimeters 

introduced by the NRC is arbitrary and 

not based on any clinical data; and (5) 

that the ACMUI in 2008 recommended 

a source strength ME definition for 

permanent implants and explicitly 

stated it should not include absorbed 

dose criteria. 

Response: The rule text was modified 

based on this comment. The rule text in 

§ 35.3045(a)(2) was modified to remove 

§ 35.3045(a)(2)(iii) and (iv), which 

would have required the assessment of 

the absorbed dose to normal tissue 

outside and within the treatment site. 

The rule text, as proposed in 

§ 35.40(b)(6)(i), contains a requirement 

to include the intended absorbed dose 

to the treatment site. However, in 

response to other comments, the NRC 

has decided to remove this requirement 

from the final rule. The commenter is 

correct that in 2008 the ACMUI 

recommended source-strength based 

criteria. However, in 2012, the ACMUI 

recommended the proposed ‘‘hybrid’’ 

criteria for reporting MEs for permanent 

implants, and that recommendation was 

endorsed by the American Association 

for Radiation Oncology. The NRC 

understands the commenter’s concerns 

that regulatory personnel may have 

difficulty assessing permanent implants 

under the proposed rule, and that 

different licensees may use different 

criteria for determining a successful 

implant. The NRC agrees that the 

proposed absorbed dose-based criteria 

are not based upon clinical data. In 

response to these concerns and those 

raised by other commenters, the NRC 

removed the absorbed dose-based ME 

reporting criterion in § 35.3045(a)(2)(iii) 

and (iv). 

Comment: Two commenters stated 

that in 2008, the ACMUI recommended 

source strength ME definition for 

permanent implants. The commenters 

stated that nevertheless, the NRC staff 

added an absorbed dose-based criterion 

to the definition, and the Commission 

rejected it. The NRC held national 

stakeholder workshops in 2011 on this 

issue and the overwhelming consensus 

at each workshop attended by 

professional organizations and 

radiological professionals was to have 

source-strength ME reporting criteria 

rather than absorbed dose-based criteria. 

The commenters also pointed out that 

the ACMUI presentations at these 

workshops stated that source strength 

criteria were preferable. The 

commenters recommended that the NRC 


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provide a more comprehensive 

regulatory basis for deviating from these 

recommendations. One of the 

commenters stated that the NRC needs 

to base the ME definition on source 

strength rather than the proposed hybrid 

definition based on source strength and 

absorbed dose, by removing 

§ 35.41(b)(6)(iii) and (iv) and amending 

§ 35.3045(a)(2). 

Response: The rule text was modified 

based on these comments. The rule text 

in § 35.3045(a)(2) was modified to 

remove § 35.3045(a)(2)(iii) and (iv), 

which would have required the 

assessment of the absorbed dose to 

normal tissue outside and within the 

treatment site. A corresponding change 

was made to the rule text in 

§ 35.41(b)(6) to remove § 35.41(b)(6)(iii) 

and (iv). The NRC agrees with the 

commenters’ stated timeline of events 

regarding ME reporting criteria 

recommendations. However, in 2012, 

the ACMUI recommended the proposed 

‘‘hybrid’’ criteria for reporting MEs for 

permanent implants, and that 

recommendation was endorsed by the 

American Association for Radiation 

Oncology. This recommendation was 

one of the key components of the NRC’s 

regulatory basis for the proposed rule. In 

response to other comments, the NRC 

removed the absorbed dose-based ME 

reporting criterion in § 35.3045(a)(2)(iii) 

and (iv) and the requirements in 

§ 35.41(b)(6)(iii) and (iv) for 

determination of absorbed dose to 

normal tissue outside and within the 

treatment site. 

Issue: Alternate Recommendations for 

ME Definitions for Permanent Implants 

Comment: One commenter suggested 

that the NRC require licensees to 

establish a ‘‘peer review’’ process in 

conjunction with the requirements that 

licensees establish procedures that 

provide ‘‘high confidence’’ that the WD 

is fulfilled. The commenter stated that 

MEs should be rare mistakes because 

the procedures are required to be 

performed by physicians that have the 

required T&E. The commenter also 

stated that the NRC should not try to 

regulate the ‘‘medicine side’’ and that 

the NRC’s determination of ‘‘ ‘actual or 

potential harm to a patient’ and review 

of normal tissue doses are not needed.’’ 

Response: No change was made to the 

rule text based on this comment. The 

NRC agrees that the NRC should not 

regulate the practice of medicine. In 

accordance with the Commission’s 

Medical Use Policy Statement published 

August 3, 2000 (65 FR 47654), the NRC 

does not intrude into medical 

decisionmaking except as necessary to 

provide for the safety of workers and the 

general public and to ensure that 

radionuclides are used in accordance 

with the physician’s directions. The 

NRC disagrees that it should require 

licensees to establish a peer review 

process for assessing MEs. The licensee 

makes the determination of the actual or 

potential harm to patients that might 

result from an ME. However, the NRC’s 

position is that an ME may be indicative 

of a potential problem in a medical 

facility’s use of radioactive materials 

even if it does not actually result in 

harm to the patient. 

In response to the portion of this 

comment concerning dose to normal 

tissue and other comments, the NRC 

removed the absorbed dose-based ME 

reporting criteria for normal tissue in 

§ 35.3045(a)(2)(iii) and (iv). 

Comment: One commenter suggested 

that the reporting criteria for permanent 

implants should be the ‘‘dose coverage 

to the intended target,’’ which is a much 

more meaningful indicator of the quality 

of an implant. The commenter suggested 

the use of ‘‘D90’’ and provided the D90 

definition from the AAPM Task Group 

137: ‘‘the minimum dose to the hottest 

90 percent of the target volume.’’ 

Response: No change was made to the 

rule text based on this comment. This is 

one of the few comments NRC received 

that supported dose-based ME reporting 

criteria for the treatment site. The NRC 

understands that ‘‘D90’’ is one of the 

absorbed dose-based parameters that is 

an accepted professional practice for 

assessing the clinical quality of an 

implant. However, the NRC also 

understands that ‘‘D90’’ is not the only 

dose-based parameter that is accepted 

and used. The NRC also received 

numerous other comments that 

identified technical limitations 

associated with the use of dose-based 

ME reporting criteria for permanent 

implant brachytherapy. Therefore, the 

NRC revised the permanent implant 

brachytherapy ME reporting criteria in 

§ 35.3045(a)(2) to be based only on total 

source strength, not dose. 

Comment: One commenter suggested 

that the reporting criteria for permanent 

implants should be based upon the dose 

to the organs at risk. The commenter 

provided the examples of the bladder 

and the rectum as organs at risk when 

treating the prostate with permanent 

implants. The commenter stated that 

this approach would hold the 

brachytherapist (AU) accountable for 

protecting the organs at risk but not 

penalize the AU for intentionally 

implanting sources in normal tissue for 

treatment purposes. The commenter 

also stated that ‘‘[a]nother benefit of 

both of these suggestions is that current 

brachytherapy software offers a method 

of evaluating the dose coverage to the 

target and organs at risk.’’ 

Response: No change was made to the 

rule text based on this comment. This is 

one of the few comments NRC received 

that supported the dose-based ME 

reporting criteria. The NRC received 

other comments that identified 

technical limitations associated with the 

use of a dose-based ME reporting 

criteria for dose to normal tissue from 

permanent implant brachytherapy. The 

NRC eliminated the dose-based criteria 

in § 35.3045(a)(2)(iii) and (iv) for normal 

tissue for reporting MEs. Therefore, the 

dose to the organs at risk does not need 

to be determined for ME reporting 

purposes. 

Issue: Concerns Regarding Regulators’ 

Training and Ability To Inspect and 

Assess Permanent Implants Under the 

Proposed Criteria 

Comment: Several commenters 

expressed concerns about the ability of 

regulators to assess licensees’ 

implementation of the proposed ME 

reporting criteria in § 35.3045(a)(2)(iii) 

and (iv). One commenter asked if 

inspectors are capable of evaluating the 

methods used by the licensee to 

determine the 5 contiguous cubic 

centimeter volume of normal tissue and 

related dosimetry. Another commenter 

stated that the proposed change will 

require substantial retraining of 

regulatory personnel to make 

determinations based on the new 

criteria. The commenter stated ‘‘[t]his is 

unduly burdensome and serves no real 

value since doses may be clinically off 

by 200 percent and still be viable for 

treatment.’’ Two other commenters 

stated that most regulatory personnel do 

not have the tools or expertise to assess 

a permanent implant and determine if 

any 5 contiguous cubic centimeters have 

exceeded an expected absorbed dose by 

50 percent. The commenters also 

expressed concern that the NRC has 

proposed a dose metric that is not an 

established standard of clinical practice 

and appears to infringe on the practice 

of medicine. 

Response: The rule text was modified 

based on these comments. The rule text 

in § 35.3045(a)(2) was modified to 

remove § 35.3045(a)(2)(iii) and (iv), 

which would have required the 

assessment of the absorbed dose to 

normal tissues outside and within the 

treatment site. The NRC understands the 

commenters’ concerns that regulatory 

personnel may have difficulty assessing 

permanent implants under the proposed 

rule and that the NRC proposed a 5 

contiguous cubic centimeter volume 

dose metric that is not an established 

standard of clinical practice. In response 


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to these concerns and different concerns 

raised by other commenters, the NRC 

removed the absorbed dose-based ME 

reporting criteria in § 35.3045(a)(2)(iii) 

and (iv). 

Issue: Applicability of the Proposed 

Criteria to Y–90 Microspheres 

Comment: Several commenters 

questioned whether the new permanent 

implant brachytherapy requirements at 

§ 35.3045 apply to the use of Y–90 

microspheres under § 35.1000. One 

commenter stated that these new 

requirements cause confusion when 

read in conjunction with the NRC 

licensing guidance for Y–90 

microspheres, which describes them as 

‘‘manual brachytherapy sources used for 

permanent implantation therapy.’’ The 

commenters suggested that the rule 

language be clarified to include a 

definition of the types of sources to 

which the permanent implant 

brachytherapy requirements apply so 

that it is clear whether they apply to 

Y–90 microspheres. 

Response: No change was made to the 

rule text. The term ‘‘permanent implant 

brachytherapy’’ is used to refer to 

manual brachytherapy procedures 

performed in accordance with § 35.400. 

The NRC considers Y–90 microspheres 

to be manual brachytherapy sources; 

however, they have unique properties 

that prevent them from being regulated 

under all the provisions of § 35.400 and 

are regulated under § 35.1000. 

Consequently, the ME reporting 

requirements for permanent implant 

brachytherapy do not apply to the use 

of Y–90 microspheres. 

Issue: Defining the Treatment Site in the 

Written Directive 

Comment: The commenter expressed 

concern that under the proposed rule in 

§ 35.3045(a)(2)(ii), a high quality 

implant with excellent dose statistics, 

where many seeds are implanted 

outside the Planning Target Volume 

(PTV) to ensure adequate dose coverage, 

would be viewed as an ME. The 

commenter stated that its prostate 

implant program allows for the 

implantation of I–125 seeds into normal 

tissues surrounding the prostate so that 

the prescribed dose covers a treatment 

margin (PTV) in addition to the prostate, 

in order to treat extra-capsular extension 

of prostate cancer. The commenter 

provided recommendations from the 

American Association of Physicists in 

Medicine Task Group Report 137 and 

the American Brachytherapy Society 

Prostate Low-Dose Rate Task Group 

Report on treating a margin of tissue 

outside of the prostate. The commenter 

also expressed concern with the 

criterion in § 35.3045(a)(2)(ii) because 

its vendor’s software does not currently 

have a satisfactory method of 

determining whether 20 percent of the 

source strength is outside of the 

treatment site. 

Response: No change was made to the 

rule text based on this comment. The 

NRC understands that AUs may 

intentionally implant sources into 

surrounding normal tissues. The AU 

defines the treatment site in the WD in 

any way he or she believes to be 

medically appropriate, including any 

margin or PTV structure. The NRC 

acknowledges that treatment planning 

software may not have an automated 

method to determine whether 20 

percent of the source strength is outside 

of the treatment site. It may be necessary 

for licensees to perform a manual 

determination of the number of sources 

outside the treatment site in comparison 

with the number of sources within the 

treatment site. 

Comment: One commenter stated that 

the requirement at § 35.3045(a)(2)(ii) 

would have positive impact if the 

definition of treatment site is clarified to 

include implantation of seeds in 

interstitial tissue, and not critical 

structures. The commenter believes that 

this criterion is consistent with 

clinically relevant circumstances when 

several seeds are accidentally placed in 

critical organs to the extent that they 

could cause a medically significant 

event to the patient. 

Response: No change was made to the 

rule text based on this comment. The 

NRC determined that revising the 

definition of the treatment site to 

include implantation of sources in 

interstitial tissue, and not critical 

structures, is not warranted. The AU 

defines the treatment site in the way he 

or she believes to be medically 

appropriate, which in some cases may 

include intentional implantation of 

sources in critical structures. The NRC 

has determined that the criterion in 

§ 35.3045(a)(2)(ii) appropriately 

captures those instances where 

medically significant events may occur. 

The NRC is not aware of cases where 

medically significant events have 

occurred while 20 percent or less of the 

source strength was implanted outside 

the treatment site. 

Comment: One commenter stated that 

compliance with the requirements in 

§ 35.3045 is dependent on how the 

tumor volume is defined by the 

physician. The commenter explained 

that if one AU defines the treatment site 

with ‘‘tight borders’’ the licensee may 

need to report an ME. However, if 

another AU defines the treatment site 

more ‘‘loosely,’’ an ME may not have to 

be reported. 

Response: No change was made to the 

rule text based on this comment. The 

AU defines the treatment site in the WD 

in the way he or she believes to be 

medically appropriate, including any 

margin. The AU may define the 

treatment site to include all tissues into 

which sources have been purposely 

implanted. The NRC has determined 

that the definition of the treatment site 

is a matter of medical judgment. 

Comment: One commenter stated that 

the identification of the ‘‘treatment site’’ 

is not well defined. The commenter 

stated that some facilities identify the 

treatment site as the prostate gland only 

and plan a dose margin around the 

prostate, while other facilities include a 

planning target volume (PTV) structure 

around the prostate as the treatment site 

and target coverage to that structure. 

Response: No change was made to the 

rule text based on this comment. The 

AU defines the treatment site in the WD 

in the way he or she believes to be 

medically appropriate, including any 

margin or PTV structure. 

Issue: The Complexity of the Medical 

Event Reporting Requirements as 

Currently Proposed May Create 

Confusion 

Comment: One commenter stated that 

the proposed ME reporting requirements 

are complex and may create confusion 

for regulators and the regulated 

community when applied to permanent 

prostate implant procedures. 

Response: The rule text was modified 

based on other comments. The NRC 

acknowledges the commenter’s concern 

regarding the complexity of the ME 

reporting requirements. The NRC 

received several comments raising 

concerns about specific portions of the 

proposed rule and changes were made 

in response to these comments. One of 

the major changes was to remove the 

requirements in § 35.3045(a)(2) related 

to absorbed dose to normal tissue. The 

NRC believes that these changes have 

reduced the complexity of the ME 

reporting requirements. 

Issue: NRC Should Create a New Section 

in 10 CFR Part 35 for Permanent 

Implant Brachytherapy Regulations 

Only 

Comment: One commenter 

recommended that the NRC create a 

new section in 10 CFR part 35 for 

permanent brachytherapy implants 

only. This new section should include 

the procedural requirements included in 

§ 35.41(b)(6) and ME reporting criteria 

specific to permanent brachytherapy 

implants included in § 35.3045 of the 


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proposed rule. The commenter stated 

that, if the NRC decides to create this 

new separate section, then the ME 

requirements for permanent 

brachytherapy implants should be 

separated and handled in a rulemaking 

separate from the remainder of the 

proposed amendments, to allow the 

NRC to finalize all other proposed 

amendments without delay. 

Response: No change was made to the 

placement of regulations related to 

permanent implant brachytherapy. The 

requirements for procedures requiring a 

WD, and the requirements for ME 

reporting appear in two different 

subparts of part 35—Subpart B—General 

Administrative requirements, and 

Subpart M—Reports. To separate the 

permanent implant brachytherapy 

requirements from these subparts and 

put them in a separate section would 

disrupt the logical flow of 10 CFR part 

35. 

Issue: The Compatibility Designation for 

Medical Event Reporting Under 

§ 35.3045 

Comment: One commenter stated that 

the WD requirements under 

§ 35.40(b)(6) and the procedures for 

permanent implant brachytherapy 

required under § 35.41(b)(6) should be 

deemed Compatibility Category B 

(rather than Compatibility Category C) 

such that the rules are uniform from one 

state to another to minimize confusion. 

The commenter stated that because over 

90 percent of medical licensees are 

under Agreement State authority, 

anything less than Compatibility 

Category B makes these changes ‘‘an 

over-regulation of the minority.’’ 

Response: The WD requirements 

under § 35.40(b)(6) and the procedures 

for permanent implant brachytherapy 

required under § 35.41(b)(6) are 

designated as Compatibility Category 

Health and Safety (H&S). This 

designation was not changed in the 

proposed rule. The H&S category 

contains program elements that are not 

required for compatibility, but are 

identified as having a particular health 

and safety role (i.e., adequacy) in the 

regulation of agreement material within 

the State. The commenter appears to be 

referring to the compatibility 

designation of ME reporting under 

§ 35.3045, which is designated as 

Compatibility Category C and which the 

final rule continues to designate as 

Compatibility Category C. 

Comment: One commenter stated that 

if the NRC were to revert to a lowerthan-proposed compatibility category 

(i.e., Compatibility Category C instead of 

B), then they recommend, as a last 

resort, that the NRC explicitly state in 

the preamble of the final rule that 

activity-based ME metrics are an 

essential program element, and that 

dose-based metrics are unacceptable for 

use. The commenter stated that the 

absorbed dose-based ME metrics are not 

‘‘more restrictive’’ per se, but are 

unsuitable and confusing when 

misapplied to the specific procedures in 

question. 

Response: The NRC has discussed the 

program element contained in § 35.3045 

and the essential objective of this 

program element in Part I, item 4 of this 

section based on this comment. The 

program element contained in § 35.3045 

is ME reporting, not activity-based ME 

metrics. The essential objective of this 

program element is to maintain a 

consistent national ME reporting 

program. In the final rule, the ME 

criteria for permanent brachytherapy is 

activity-based and not dose-based. Dosebased ME reporting criteria for 

permanent implant brachytherapy 

would conflict with the essential 

objective of maintaining a consistent 

national reporting program because it 

would result in insignificant events 

being reported as MEs. As explained in 

Part I, item 4 of this section, consistency 

in the national reporting program allows 

the NRC to identify trends or patterns, 

identify generic issues or concerns, 

recognize inadequacies or unreliability 

of specific equipment or procedures, 

and determine why an event occurred 

and whether any actions are necessary 

to improve the effectiveness of NRC and 

Agreement State regulatory programs. 

Dose-based ME reporting criteria would 

result in inconsistent reporting of 

permanent implant brachytherapy MEs, 

and thus would disrupt these efforts. 

Comment: One commenter stated that 

they support the Compatibility Category 

B designation for ME reporting, in 

agreement with the opinion of the 

ACMUI and for the reasons provided in 

the proposed rule. The commenter 

stated that, considering the details and 

clinical implications of the prostate 

implant procedures, it only makes sense 

to have activity-based criteria for an ME. 

The commenter believes that there is 

merit in consistent rules for subjects 

that have significant implications, such 

as the criteria for an ME, and 

standardization should remove 

uncertainty and confusion. 

Response: The NRC agrees with the 

commenter that activity-based criteria 

are appropriate for MEs for permanent 

implant brachytherapy procedures, 

including the prostate implant 

procedures. As discussed earlier in this 

section, the NRC has determined that 

Compatibility Category C is the 

appropriate designation for § 35.3045. 

The NRC determined that Compatibility 

Category B is not the appropriate 

designation because the ME reporting 

criteria, while important to the effective 

and orderly regulation of agreement 

material on a nationwide basis, do not 

have significant direct transboundary 

implications. The essential objective of 

§ 35.3045 is to maintain a consistent 

national program for reporting MEs. 

Agreement State use of dose-based 

criteria for permanent implant 

brachytherapy ME reporting would be 

inconsistent with this essential objective 

because the NRC has determined that 

dose-based criteria would result in the 

reporting of insignificant events. 

Therefore, for national reporting, 

Agreement States’ use of dose-based 

reporting criteria either instead of or in 

addition to activity-based reporting 

criteria for permanent implant 

brachytherapy would not be compatible 

with § 35.3045. 

Comment: One commenter expressed 

support of the Compatibility Category B 

designation for § 35.3045 and noted 

that, as discussed by the NRC in the 

proposed rule, some medical licensees 

practice at multiple locations, some of 

which are NRC-regulated and some of 

which are Agreement State-regulated. 

The commenter stated that a 

Compatibility Category B designation 

would allow for uniformity of practice 

and procedures across the country. The 

commenter further suggested that to 

make the move from Compatibility 

Category C to B smooth, the NRC should 

define the ‘‘essential objectives’’ of 

§ 35.3045 such that the Agreement 

States’ adoption of the new definition is 

not met with unnecessary delays. 

Response: The NRC has determined 

that Compatibility Category C is the 

appropriate category for § 35.3045, for 

the reasons explained in response to 

another comment and in Part I, item 4 

of this section. The essential objective of 

§ 35.3045 is to maintain a consistent 

national reporting program, as further 

explained in Part I, item 4 of this 

section. 

Comment: One commenter, in support 

of the Compatibility Category B, stated 

that they recognize that the Agreement 

States oppose a change in Compatibility 

Category, citing state legislative 

requirements, the difficulty in changing 

state regulations, and the fact that 

Agreement States do not perceive a 

problem with the current dose-based 

definition. The commenter believes that 

these concerns are outweighed by the 

importance of having a consistent 

definition throughout the country to 

prevent confusion and unnecessary 

reporting of otherwise medically 

acceptable procedures as MEs. The 


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commenter expressed concern that a 

Compatibility Category C designation 

would allow Agreement States to 

implement unnecessarily more 

restrictive definitions that classify 

medically acceptable procedures as 

MEs. 

Response: The NRC understands the 

importance of having consistent ME 

reporting criteria throughout the 

country to prevent confusion and 

unnecessary reporting of otherwise 

medically acceptable procedures as ME. 

This consistency is necessary to meet 

the essential objective of § 35.3045, 

which is to maintain a consistent 

national reporting program. The NRC 

disagrees that Compatibility Category B 

is the appropriate category for § 35.3045 

and instead has determined that 

Compatibility Category C is the 

appropriate category. Therefore, 

Agreement States are required to adopt 

the essential objectives of this provision, 

but are not required to adopt essentially 

identical ME reporting criteria. The 

Agreement States have the flexibility to 

include, for example, a shorter reporting 

time in their ME reporting criteria, but 

the use of dose-based ME reporting 

criteria for permanent implant 

brachytherapy would create conflicts 

and inconsistencies with respect to the 

national reporting program, because it 

would capture insignificant events as 

MEs. 

Comment: Two commenters in 

support of Compatibility Category B 

stated that because over 90 percent of 

medical licensees are under Agreement 

State authority, anything less than 

Compatibility Category B makes the 

proposed changes an ‘‘over-regulation of 

the minority.’’ The commenters stated 

that it would be counterproductive for 

Agreement States to maintain 

alternative ME criteria not listed in the 

revised § 35.3045. The commenters 

further stated that because certain 

healthcare systems may be providing 

services in both NRC and Agreement 

State jurisdictions, § 35.3045 should be 

designated as Compatibility Category B. 

One commenter said that they strongly 

support the proposed designation of 

Compatibility Category B for § 35.3045, 

thereby requiring Agreement States to 

adopt ME reporting and notification 

program elements essentially identical 

to NRC’s. The commenter also stated 

that it would be counterproductive for 

Agreement States to maintain 

alternative ME criteria not listed in the 

revised § 35.3045. The commenter 

stated that if the dose-based ME 

reporting criteria were interpreted by 

the States as more ‘‘restrictive,’’ and 

States were to continue to have some 

manner of ill-fitting ME methodology, 

this would confuse the regulated 

community and continue to weaken 

confidence in the significance of 

reported permanent brachytherapy MEs. 

Response: As explained in response to 

other comments, the NRC has 

determined that Compatibility Category 

C is the appropriate category for 

§ 35.3045. Under Compatibility Category 

C, Agreement States will not be able to 

maintain alternative ME criteria not 

listed in the revised § 35.3045, if those 

criteria would create conflicts or 

inconsistencies in the national reporting 

program. The NRC understands the 

commenter’s concern that alternative 

ME criteria could weaken the public’s 

confidence in the significance of 

permanent implant brachytherapy MEs. 

Therefore, the NRC has identified dosebased criteria as an example of 

alternative ME reporting criteria that 

would capture insignificant events as 

MEs and create a conflict and 

inconsistency in the national reporting 

program. 

Comment: Several commenters stated 

that their medical practices are affected 

by the compatibility category assigned 

to § 35.3045. They said that they are 

pleased with the Commission’s decision 

to move § 35.3045 from Compatibility 

Category C to Compatibility Category B. 

The commenters stated that it is 

essential that § 35.3045 be defined and 

implemented in a consistent manner 

across the country. The commenters 

stated that, as the NRC noted in the 

proposed rule, some medical licensees 

practice at multiple locations, some of 

which are NRC-regulated and some of 

which are Agreement State-regulated. 

The commenters stated that there are 

many practices that extend beyond one 

particular jurisdiction, usually when the 

main center is near a state border. The 

commenters further stated that they 

expect this situation to increase 

significantly in the coming few years as 

the consolidation of healthcare 

institutions into larger entities 

continues to accelerate. Therefore, a 

Compatibility Category B designation 

would allow for uniformity of practice 

and procedures across the country. 

Response: The NRC understands the 

commenters’ concern that § 35.3045 be 

defined and implemented in a 

consistent manner across the country. 

As noted by the commenter, and as the 

NRC noted in the proposed rule, some 

medical licensees practice at multiple 

locations, some of which are NRCregulated and some of which are 

Agreement State-regulated. 

The NRC disagrees that § 35.3045 

should be designated as Compatibility 

Category B to ensure uniformity of 

practice and procedures across the 

country. The NRC designates regulatory 

program elements as Compatibility 

Category B if they have significant direct 

transboundary implications, not simply 

for the purpose of ensuring uniformity 

across the country with respect to a 

program element. The effect of a 

Compatibility Category B designation is 

essentially uniformity across the 

country with respect to a program 

element, because this designation 

requires Agreement States to adopt 

program elements that are ‘‘essentially 

identical’’ to that of the NRC. This 

uniformity is necessary because a 

program element has significant direct 

transboundary implications. As 

discussed in Part I, item 4 of this 

section, the NRC has determined that 

ME reporting does not rise to the level 

of having significant direct 

transboundary implications. Therefore, 

Compatibility Category B is 

inappropriate. 

The NRC has determined that 

Compatibility Category C is the 

appropriate designation for § 35.3045. 

Under Compatibility Category C 

designation, the essential objectives of 

the regulation should be adopted by the 

State to avoid conflicts, duplications or 

gaps. The essential objective of 

§ 35.3045 is to maintain a consistent 

national ME reporting program. 

Agreement States should ensure that 

their ME reporting criteria do not 

conflict with or create inconsistency 

within this program. 

Comment: One of the Agreement 

States stated that all MEs are local 

events and are not transboundary 

events, regardless of their significance. 

The commenter stated that even 

multiple events with a common root 

cause are considered local events and 

each licensee is required to submit an 

ME report to its licensing authority. The 

commenter also stated that all MEs are 

reported in the Nuclear Materials Event 

Database, so NRC is notified of all 

events that meet the NRC’s ME criteria. 

Response: The NRC acknowledges 

that, from the perspective of a single 

medical facility, MEs appear to be local 

events only. The NRC has determined 

that ME reporting does not rise to the 

level of having significant direct 

transboundary implications and; 

therefore, Compatibility Category B is 

inappropriate. However, to ensure that 

an Agreement State program meets the 

essential objective of § 35.3045 to 

maintain a consistent national ME 

reporting program, the Agreement 

States, for permanent implant 

brachytherapy treatments, should not 

use the dose-based criteria. For the 

reasons explained in response to other 

comments and in Part I, item 4 of this 


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section, the use of dose-based criteria 

would create conflicts and 

inconsistencies in the national ME 

reporting program. 

Comment: Several commenters 

opposing the proposed category B 

designation for ME reporting questioned 

how a single medical incident at a 

single facility can have ‘‘direct and 

significant effects in multiple 

jurisdictions.’’ They further added that 

the Compatibility Category C 

designation has been adequate for the 

reporting requirements for radiography, 

irradiator, and well logging licensees 

who routinely work in multiple 

jurisdictions. 

Response: The NRC agrees that the 

Compatibility Category C designation 

has been adequate for the reporting 

requirements for radiography, irradiator, 

and well logging licensees who work 

routinely in multiple jurisdictions. The 

NRC has determined that Compatibility 

Category C is also the appropriate 

designation for § 35.3045. 

The NRC acknowledges that, from the 

perspective of a single medical facility, 

MEs appear to be local events only. The 

NRC agrees that ME reporting does not 

have direct and significant effects in 

multiple jurisdictions, and therefore 

agrees that Compatibility Category B is 

not the appropriate designation for 

§ 35.3045. Therefore, the ME reporting 

criteria do not have to be essentially 

identical. However, the essential 

objective of § 35.3045 is to maintain a 

consistent national ME reporting 

program, and to adopt this essential 

objective Agreement States should 

adopt ME reporting criteria that do not 

create conflicts or inconsistencies in ME 

reporting. The ME reporting program 

ensures that the NRC and Agreement 

States are able to identify trends or 

patterns, identify generic issues or 

concerns, recognize inadequacies or 

unreliability of specific equipment or 

procedures, and determine why an 

event occurred and whether any actions 

are necessary to improve the 

effectiveness of NRC and Agreement 

State regulatory programs. Inconsistent 

or conflicting ME reporting criteria 

would frustrate these purposes. 

Comment: Several commenters, in 

support of the Compatibility Category C 

designation for ME reporting under 

§ 35.3045, stated that currently the only 

reporting regulations with a 

Compatibility Category B designation 

are related to the security requirements 

and are located in other parts of 10 CFR. 

The commenter also stated that all the 

reporting requirements found in 10 CFR 

part 35 are Compatibility Categories C, 

H&S, or D. Since § 35.3045 is a reporting 

requirement and does not relate to the 

security of Category 1 or Category 2 

sources, the commenter recommended 

that the compatibility category for the 

reporting requirements in § 35.3045 

remain as Compatibility Category C. 

Response: It is true that currently the 

only reporting regulations with 

Compatibility Category B designation 

are related to the security requirements 

and are located in other parts of 10 CFR. 

However, that does not preclude the 

NRC from categorizing reporting 

requirements as Compatibility Category 

B. Compatibility category designations 

do not hinge on whether a regulatory 

requirement pertains to security or any 

other discrete regulatory issue. Rather, 

the NRC assigns the appropriate 

category for each regulatory requirement 

by considering and applying the criteria 

for Agreement State compatibility to 

each particular regulatory requirement. 

For the reasons stated in response to 

other comments and as discussed in 

Section V., Public Comment Analysis, 

the NRC has determined that 

Compatibility Category C is the 

appropriate designation for § 35.3045. 

Comment: One commenter, in support 

of the Compatibility Category C 

designation for ME reporting under 

§ 35.3045, stated that throughout 

§ 35.3045, the term ‘‘treatment site’’ is 

used, that it is specifically defined in 

§ 35.2, and that this definition has been 

designated Compatibility Category C. 

The commenter stated that since the 

definition of ‘‘treatment site’’ is 

remaining a Compatibility Category C, it 

is possible for an Agreement State to 

adopt the essential objective of the 

definition but it may be a slightly 

different definition. If the definition for 

treatment site is slightly different in 

each jurisdiction, even if § 35.3045 is 

changed to a Compatibility Category B, 

the requirement may not be ‘‘essentially 

identical’’ in each jurisdiction. 

Response: It is true that the 

‘‘treatment site’’ is defined in § 35.2 and 

that this definition has been designated 

Compatibility Category C. While the 

NRC may assign a particular 

compatibility category to certain 

definitions, the regulations in which 

these terms are used are not confined to 

this same category. Instead, the NRC 

assigns the appropriate category for each 

regulatory requirement by considering 

and applying the criteria for Agreement 

State compatibility to each particular 

regulatory requirement. 

Comment: One commenter 

recommended that, if the NRC insists on 

changing the Compatibility Category to 

B, then the rule language should be 

changed to only require the 

Compatibility Category B designation 

for permanent prostate implant 

procedures and no other permanent 

brachytherapy procedures. The 

commenter further stated that the main 

impetus for changing the compatibility 

category for ME reporting appears to be 

the multiple prostate implant MEs that 

occurred at the Department of Veterans 

Affairs facilities. 

Response: When drafting the ME 

reporting requirements for permanent 

implant brachytherapy procedures at 

§ 35.3045(a)(2), the NRC developed 

requirements that would apply to 

permanent implant procedures for all 

treatment sites, including prostate 

implants. Although prostate implants 

are more common than other implants, 

the NRC staff in SECY–12–0053 

recommended that the revised ME 

criteria apply to permanent implant 

procedures for all treatment sites, not 

only the prostate. The NRC has 

determined that the prostate implant 

procedure does not warrant a separate 

set of regulations and that including 

them in the ME reporting requirements 

for permanent implant procedures for 

all treatment sites is sufficient to ensure 

that significant events involving 

prostate implants will be reported as 

MEs. As explained in response to other 

comments and in Part I, item 4 of this 

section, the NRC has determined that 

Compatibility Category C is appropriate 

for all of § 35.3045, including 

permanent implant brachytherapy 

procedures, such as prostate implants. 

Comment: One Agreement State 

stated that the proposed activity-based 

ME reporting criteria should be added to 

the existing dose-based criteria, rather 

than replace it. The Agreement State 

stated that it would require licensees to 

apply both criteria, and only those MEs 

that meet the NRC’s proposed activitybased criteria would be reported to the 

NRC. The commenter explained that 

this approach would provide the states 

with the needed flexibility to regulate 

both radioactive materials and machineproduced sources of radiation in a 

consistent manner. The commenter also 

stated that the ME reporting regulations 

should not be categorized as 

Compatibility Category B because that 

would restrict the State’s ability to 

regulate the clinical aspects of the 

practice of medicine and patient 

management. 

Response: The NRC has determined, 

as recommended by the medical 

community, that the activity-based 

criteria are more appropriate for 

permanent implant brachytherapy 

procedures than the dose-based criteria, 

because activity-based criteria 

specifically captures significant events 

for reporting as MEs whereas dose-based 

criteria would capture insignificant 


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events as well. The NRC has determined 

that Compatibility Category C is the 

appropriate designation for § 35.3045. 

However, as explained in response to 

other comments and in Part I, item 4 of 

this section, the NRC has determined 

that Agreement State use of dose-based 

criteria for permanent implant 

brachytherapy ME reporting would 

result in inconsistencies and conflicts 

with the essential objective of § 35.3045, 

which is to maintain a consistent 

national ME reporting program. 

Section 35.3204 Report and 

Notification for an Eluate Exceeding 

Permissible Molybdenum-99, 

Strontium-82, and Strontium-85 

Concentrations 

Comment: Two commenters 

supported the proposed generator 

elution breakthrough reporting 

requirements. 

Response: The comment supports 

language in the rule; therefore, no 

response is required. 

Comment: One commenter noted that 

Tc-99m decays much faster than Mo-99; 

therefore, every Tc-99m generator eluate 

will eventually exceed the regulatory 

limit. Because of this, the commenter 

stated that the language in the proposed 

rule text would require every eluate to 

be reported. The commenter proposed 

revising the rule text in § 35.3204(a) to 

clarify that the licensee would only 

report measurements of a Tc-99m 

generator elution that exceeded the 

regulatory limits at the time of generator 

elution. 

Response: The rule text was modified 

based on this comment. The NRC agrees 

with the commenter that the proposed 

rule text in § 35.3204(a) and (b) was not 

clear and has amended it to clarify that 

the reporting requirements only apply at 

the time of generator elution. 

Comment: One commenter stated that 

the reporting and notification 

requirement for failed Mo-99/Tc-99m 

and Sr-82/Rb-82 generators was 

increased from Compatibility Category C 

to Compatibility Category B. The 

commenter supports adding specific 

reporting criteria for failed generators, 

but wanted to retain the Compatibility 

Category as C. 

Response: No change was made to the 

compatibility category for reporting and 

notification requirement for failed Mo99/Tc-99m and Sr-82/Rb-82 generators 

based on this comment. In the proposed 

rule, the NRC designated the reporting 

requirements in § 35.3204(a) and (b) as 

Compatibility Category C. The final rule 

retains the same compatibility category 

for reporting requirements in 

§ 35.3204(a) and (b). 

Comment: Two commenters agreed 

with the proposed revision but asserted 

that the proposed § 35.3204(a) initial 

requirement to report to the NRC 

Operations Center within 30 days 

should be shortened. One commenter 

stated that a shorter reporting 

requirement was needed to more 

effectively address patient safety 

concerns. The other commenter stated 

that in order to respond in a timely 

manner to potential issues regarding the 

manufacturing and/or use of generators, 

the reporting period should be less than 

30 days. 

Response: The rule text was modified 

based on these comments. The rule text 

in § 35.3204(a) was revised to require 

notification within 7 calendar days. The 

NRC agrees that the time period for 

notification should be shorter than the 

proposed 30 calendar days. With the 

short half-lives of the parent 

radionuclides, the NRC determined that 

a 7 calendar-day notification 

requirement is more appropriate. Seven 

calendar days gives the licensee an 

opportunity to evaluate its procedures, 

measurements, and calculations to 

determine if the generator actually 

failed, i.e., the eluate actually exceeded 

the permissible concentration, or if the 

licensee made an error. The shorter 

reporting requirement would also 

permit the NRC to determine the extent 

of generator failures and take quicker 

action to protect patient safety. 

Comment: Several Agreement States 

disagree that the notification of the 

discovery of an eluate exceeding the 

limits should be made to the NRC 

Operations Center. They recommended 

that a report be submitted to the NRC 

regional offices instead. The 

commenters stated that any 30-day 

notification to the Agreement States 

must only be submitted to the NRC 

using the National Materials Events 

Database (NMED), not the Operations 

Center. One commenter stated that the 

doses received from most generators 

that exceed the eluate breakthrough 

limits would not meet the reporting 

requirement for a diagnostic ME and 

therefore does not meet the urgency for 

reporting to the Operation Center. The 

commenter used the CardioGen® Sr/Rb 

generator recall as an example. Further, 

the commenter stated that the current 

Integrated Materials Performance 

Evaluation Program requirement to 

report such events to the NMED is more 

than sufficient. One commenter stated 

that ‘‘[s]hould a trend of these events be 

found, the Agreement States currently 

report these events to the Regional 

Agreement State Officer.’’ 

Response: No change was made to the 

rule text based on these comments. The 

NRC determined that it is appropriate to 

report generator failures (i.e., when the 

eluate exceeds the permissible 

concentration listed in § 35.204(a)) to 

the NRC Operations Center. Reporting to 

the NRC Operations Center will permit 

the NRC to identify whether this is a 

limited or more widespread failure of 

generators and share that information in 

a timely manner. 

Comment: Several commenters 

recommended that the NRC implement 

the ACMUI recommendation to only 

require licensees to report generator 

elution results with parent breakthrough 

beyond the § 35.204(a) limits to the 

manufacturer/distributor, and not to 

both the manufacturer/distributor and 

the NRC. The commenters stated that 

only the manufacturer/distributor 

should be responsible for reporting ‘‘the 

out-of-tolerance parent breakthroughs to 

the NRC.’’ The commenters also stated 

that requiring the licensee to report to 

both the company and the NRC, while 

the company also reports to NRC, is 

unnecessarily duplicative. 

Response: A clarifying revision was 

made to the rule text. The NRC requires 

that a licensee report to the NRC and the 

generator distributor, which also may 

sometimes be the manufacturer, when it 

identifies a generator with an eluate 

exceeding the permissible concentration 

limits in § 35.204(a). The NRC requires 

this reporting because it is important 

that the NRC and the distributors be 

aware of such events in a timely 

manner. The reporting requirement is 

not duplicative because the NRC does 

not require the distributor to report 

generator failures to the NRC. 

VI. Section-by-Section Analysis 

This section describes the specific 

amendments by section for this final 

rule. 

Section 30.34 Terms and Conditions of 

Licenses 

Paragraph (g). This paragraph adds a 

new requirement for licensees to report 

to the NRC when generator eluates 

exceed the permissible Mo-99 or Sr-82 

and Sr-85 concentration limits listed in 

§ 35.204(a). Reporting must be in 

accordance with the reporting and 

notification requirements in § 35.3204. 

While the reporting requirement as well 

as the requirement to test every Mo-99 

elution is new, the testing by licensees 

of the first elution to ensure that it does 

not exceed the permissible 

concentration listed in § 35.204(a) and 

recording the results of these tests is 

already required by this paragraph. 

This change provides the information 

to allow the NRC to assess a potential 

situation quickly and efficiently when 


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issues occur with generators that may 

cause unwarranted radiation exposure 

to patients. This issue is discussed 

further in Section III., Discussion, of this 

document. 

Section 32.72 Manufacture, 

Preparation, or Transfer for Commercial 

Distribution of Radioactive Drugs 

Containing Byproduct Material for 

Medical Use Under Part 35 

Paragraph (a)(4). This paragraph is 

amended to clarify that the applicant 

‘‘commits to’’ rather than ‘‘satisfies’’ the 

labeling requirements. Committing to 

the prescriptive labeling requirements 

in the regulation in the license 

application would remove ambiguity 

related to what must appear on the 

label. 

Paragraph (b)(5)(i). This paragraph is 

amended to remove the requirement to 

obtain a written attestation for 

individuals seeking to be named as an 

ANP and who are certified by a 

specialty board whose certification 

process has been recognized by the NRC 

or an Agreement State to be an ANP. 

This is a conforming change in support 

of the removal of the attestation 

requirement in § 35.55(a) of this chapter 

for a board-certified ANP. 

Paragraph (d). The existing 

requirements in paragraph (d) are redesignated as (e), and a new paragraph 

(d) is added to clarify that the labeling 

requirements that applicants commit to 

in paragraph (a) of this section are also 

applicable to current licensees. 

Section 35.2 Definitions 

New definitions for Associate 

Radiation Safety Officer and for 

Ophthalmic physicist are added to this 

section and the definition for Preceptor 

is amended. 

The new definition for Associate 

Radiation Safety Officer identifies the 

requirements an individual will need to 

meet to be recognized as an ARSO. 

These requirements include that the 

individual must meet the specified T&E 

criteria and that the individual be 

currently listed as an ARSO on a 

medical use license or permit for the 

types of use of byproduct material for 

which the individual had been assigned 

tasks and duties by the RSO. Additional 

information on ARSOs is located in 

Section III, Discussion, of this 

document. 

The new definition for Ophthalmic 

physicist identifies the requirements an 

individual will need to meet to be 

recognized as an Ophthalmic physicist. 

These requirements include that the 

individual must meet the specified T&E 

criteria in §§ 35.433(a)(2) and 35.59 and 

that the individual must be currently 

listed as an Ophthalmic physicist on a 

(1) specific medical use license issued 

by the Commission or an Agreement 

State; (2) permit issued by a 

Commission or Agreement State broad 

scope medical use licensee; (3) medical 

use permit issued by a Commission 

master material licensee; or (4) permit 

issued by a Commission master material 

licensee broad scope medical use 

permittee. A written attestation will not 

be required for this individual. 

The definition for Preceptor is 

amended to add ARSO to the list of 

individuals whose T&E is provided, 

directed, or verified by a preceptor. This 

is a conforming change in support of the 

new definition for Associate Radiation 

Safety Officer. 

Section 35.8 Information Collection 

Requirements: OMB Approval 

Paragraph (b). This paragraph is 

amended to include § 35.3204 in the list 

of sections in which the approved 

information collection requirements are 

contained. 

Section 35.12 Application for License, 

Amendment, or Renewal 

This section is amended to require 

only the submission of the original NRC 

Form 313, Application for Material 

License, or a letter containing 

information required by NRC Form 313 

when applying for a license, an 

amendment, or renewal. This section 

clarifies what information should be 

submitted and adds a requirement to 

submit information on an individual 

seeking to be identified as an ARSO or 

as an ophthalmic physicist. 

Paragraph (b)(1). As part of the 

application for a medical use license, 

this paragraph is amended to require the 

submittal of only the original NRC Form 

313. This change will relieve the burden 

on the applicant by requiring less 

paperwork to be submitted. It will also 

require the applicant to submit the T&E 

qualifications for one or more ARSOs 

and ophthalmic physicists that are to be 

identified on the license. 

Paragraph (c). For license 

amendments or renewals, this paragraph 

is amended to require the submittal of 

only the original NRC Form 313 or a 

letter containing information required 

by NRC Form 313. This change will 

relieve the burden on the licensee by 

requiring less paperwork to be 

submitted. Additionally, it clarifies that 

the letter submitted in lieu of NRC Form 

313 must contain all the information 

required by NRC Form 313. 

Paragraph (d). This paragraph is 

amended and restructured to clarify 

what information must be included in 

an application for a license or 

amendment for medical use of 

byproduct material as described in 

§ 35.1000. 

Section 35.13 License Amendments 

This section is amended by revising 

paragraph (b), re-designating paragraphs 

(d) through (g) as paragraphs (e) through 

(h), revising re-designated paragraphs 

(g) and (h), and adding new paragraphs 

(d) and (i). 

Paragraph (b). This paragraph is 

amended to allow a licensee to permit 

an individual to work as an ophthalmic 

physicist before applying for a license 

amendment, provided that the 

individual is already identified on a 

medical license or permit provided for 

in § 35.13(b)(4). 

Paragraph (d). This new paragraph 

requires a licensee to apply for and 

receive a license amendment before 

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. 

Paragraph (i). This new paragraph 

allows a licensee to receive sealed 

sources 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 its 

license without first seeking a license 

amendment. This change provides 

manual brachytherapy licensees greater 

flexibility in obtaining the sealed 

sources necessary for patient treatments 

in a timely manner. 

Section 35.14 Notifications 

Paragraph (a). The paragraph is 

restructured to separate the notification 

requirements for an individual who is 

certified by a board that is recognized by 

the NRC or an Agreement State from the 

requirements for an individual who is 

not certified by a board that is 

recognized by the NRC or an Agreement 

State but is listed on a license. 

Additionally, the requirement to 

provide a written attestation is removed 

for an individual who is certified by a 

board that is recognized by the NRC or 

an Agreement State. Further discussion 

on removing the written attestation 

requirement can be found in Section III, 

Discussion, of this document. Licensees 

may not permit an individual who is not 

certified by a board that is recognized by 

the NRC or an Agreement State or does 

not meet the requirements in § 35.13(b) 

to work under their license without first 

obtaining an amendment to their 

license. 

Paragraph (a)(1). This paragraph is 

restructured to more clearly identify the 

verification that a board-certified 

individual will need to provide along 


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with a copy of the individual’s board 

certification. This change does not 

impose any new requirements. 

Paragraph (a)(2). This paragraph 

retains the notification requirements for 

individuals who are authorized to work 

under § 35.13(b) who are not certified by 

a board that is recognized by the NRC 

or an Agreement State but are listed on 

a license. The sentence in the proposed 

rule under § 35.14(a)(2), ‘‘The licensee 

shall only permit the individual to work 

with materials and uses previously 

authorized as an authorized user, an 

authorized medical physicist, 

ophthalmic physicist, or an authorized 

nuclear pharmacist under § 35.13(b)’’ is 

deleted in the final rule. The NRC is 

removing this sentence because it is not 

necessary and the requirements are 

already addressed in § 35.13(b). 

Paragraph (b)(1). This paragraph is 

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 his or her duties under 

the license. 

Paragraph (b)(5). This paragraph is 

revised from the proposed rule 

language. In the proposed rule, the 

structure of § 35.14(b)(5) was changed 

and this resulted in substantive changes 

to the paragraph. The NRC did not 

intend to change the requirements in 

this paragraph. 

Paragraph (b)(6). This new paragraph 

requires 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 listed in the 

SSDR for manual brachytherapy for 

quantities and isotopes already 

authorized by the license. 

Section 35.15 Exemptions Regarding 

Type A Specific Licenses of Broad 

Scope 

This section is amended to make 

corresponding changes based on 

amendments to § 35.13 and to 

§ 35.14(b)(1). 

Paragraph (c). This paragraph is 

amended to update the reference from 

§ 35.13(e) to § 35.13(f) as a result of 

amendments to § 35.13. 

Paragraph (e). This paragraph is 

amended to include ophthalmic 

physicist as a result of amendments to 

§ 35.14(b). 

Section 35.24 Authority and 

Responsibilities for the Radiation 

Protection Program 

This section is amended to allow 

licensees to appoint qualified 

individuals with expertise in certain 

uses of byproduct material to be named 

as ARSOs on a license or permit. 

Paragraph (b). This paragraph is 

modified to specify that a licensee’s 

management may appoint one or more 

ARSOs. These appointed ARSOs must 

be named on a medical license or permit 

for the types of use of byproduct 

material for which the RSO, with the 

written agreement of the licensee’s 

management, would assign tasks and 

duties. 

The licensee’s management is still 

limited to naming one RSO who will 

remain responsible for implementing 

the entire radiation protection program. 

The RSO is prohibited from delegating 

authority and responsibilities for 

implementing the radiation protection 

program. The proposed rule would have 

required each ARSO to agree in writing 

to the tasks and duties assigned by the 

RSO. The NRC staff determined that this 

requirement is not necessary because 

the NRC holds the RSO responsible for 

implementing the radiation protection 

program. Therefore, the proposed 

requirement for each ARSO to agree in 

writing to the tasks and duties assigned 

by the RSO is not included in this final 

rule. 

Paragraph (c). An administrative 

change is made to this paragraph to 

remove the phrase ‘‘an AU or’’ because 

it is redundant with ‘‘an individual 

qualified to be a Radiation Safety Officer 

under §§ 35.50 and 35.59’’ in the same 

sentence. 

The position of an ARSO is discussed 

further in Section III, Discussion, of this 

document. 

Section 35.40 Written Directives 

Paragraph (b). This paragraph is 

restructured and amended to 

accommodate specific requirements for 

a WD for permanent implant 

brachytherapy. Existing paragraph (b)(6) 

is re-designated as paragraph (b)(7) and 

a new paragraph (b)(6) is added to 

specify the information that must be 

included in the pre-implantation (before 

implantation) and post-implantation 

(after implantation) portions of the WD 

for permanent implant brachytherapy. 

Paragraph (b)(6). This new paragraph 

provides details of the specific WD 

requirements for permanent implant 

brachytherapy. Specifically, it clarifies 

that the WD is divided into two 

portions, i.e., the pre-implantation 

portion and the post-implantation 

portion. The pre-implantation portion of 

the WD requires documentation of the 

treatment site, the radionuclide, and the 

total source strength. The information 

required by the pre-implantation 

portion of the WD must be documented 

prior to the start of the implantation. 

The post-implantation portion of the 

WD requires the documentation of the 

treatment site, number of sources 

implanted, the total source strength 

implanted, and the date. The 

information required by the postimplantation portion of the WD must be 

documented before the patient leaves 

the post-treatment recovery area. 

Paragraph (c). This paragraph is 

restructured for clarity. 

Section 35.41 Procedures for 

Administrations Requiring a Written 

Directive 

This section is amended by adding 

two new paragraphs with requirements 

that the licensee must address when 

developing, implementing, and 

maintaining written procedures to 

provide high confidence that each 

administration requiring a WD is in 

accordance with the WD. 

Paragraph (b)(5). This new paragraph 

requires that the licensee’s procedures 

for any administration requiring a WD 

include procedures for determining if an 

ME, as defined in § 35.3045 of this part, 

has occurred. 

Paragraph (b)(6). This new paragraph 

requires the licensee to develop specific 

procedures for permanent implant 

brachytherapy programs. At a 

minimum, the procedures will include 

determining post-implant source 

position within 60 calendar days from 

the date the implant was performed. If 

the licensee cannot make these 

determinations within the 60 calendar 

days because the patient is not 

available, then the licensee must 

provide written justification that this 

determination could not be made due to 

patient unavailability. 

The determination that is required 

includes the total source strength 

administered outside of the treatment 

site compared to the total source 

strength documented in the postimplantation portion of the WD. 

A 60-calendar-day time frame ensures 

that the licensee has ample time to make 

arrangements for the required 

determinations. These determinations 

are used to partially assess if an ME, as 

defined in § 35.3045, has occurred. 

Section 35.50 Training for Radiation 

Safety Officer and Associate Radiation 

Safety Officer 

Multiple changes are made to this 

section. They include amending the title 

of this section to add ‘‘and Associate 

Radiation Safety Officer’’ because the 

T&E requirements for this new position 

are also applicable to the ARSO. Other 

changes are: (1) Removing the 

requirement to obtain a written 

attestation for individuals qualified 

under paragraph (a) of this section; (2) 

adding a provision that will allow 


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individuals identified as an AU, AMP, 

or ANP on a medical license to be an 

RSO or an ARSO not only on that 

current license but also on a different 

medical license; (3) adding a provision 

to allow an individual to be named 

simultaneously both as the RSO and AU 

on a new license application; and (4) 

making certain administrative 

clarifications. 

Paragraph (a). The requirement for 

individuals seeking to be named as an 

RSO or ARSO to obtain a written 

attestation is removed for those 

individuals who are certified by a 

specialty board whose certification 

process has been recognized by the NRC 

or an Agreement State. Individuals 

seeking to be named as RSOs or ARSOs 

via the certification pathway still need 

to meet the training requirements in the 

new paragraph (d) of this section. 

Further discussion on removing the 

written attestation requirement can be 

found in Section III, Discussion, of this 

document. 

Paragraph (b)(1)(ii). This paragraph is 

amended to allow an ARSO, in addition 

to the RSO, to provide supervised work 

experience for individuals under the 

alternate pathway. The ARSO is limited 

to providing supervised work 

experience in those areas for which the 

ARSO is authorized on a medical 

license or permit. 

Paragraph (b)(2). Reserved paragraph 

(b)(2) is revised to include the 

requirements for an RSO or ARSO under 

the alternate pathway to obtain a written 

attestation signed by either an RSO or 

ARSO. The language that is required in 

the written attestation is amended to 

state that the individual ‘‘is able to 

independently fulfill the radiation 

safety-related duties as an RSO or 

ARSO,’’ rather than that the individual 

‘‘has achieved a level of radiation safety 

knowledge to function independently’’ 

as an RSO or ARSO. 

Paragraph (c)(1). This paragraph is 

modified to allow medical physicists 

who have been certified by a specialty 

board whose process has been 

recognized by the Commission or an 

Agreement State under § 35.51(a) to be 

named as ARSOs. Additionally, the 

requirement for a written attestation for 

these medical physicists is removed. A 

medical physicist seeking to be named 

as an RSO or an ARSO still must meet 

the training requirements in paragraph 

(d) of this section. 

Paragraph (c)(2). This paragraph is 

modified to allow AUs, AMPs, and 

ANPs identified on a Commission or an 

Agreement State medical license or 

permit to be an RSO or ARSO on any 

Commission or an Agreement State 

license or Commission master material 

license permit provided that the AU, 

AMP, or ANP has experience with the 

radiation safety aspects of similar types 

of use of byproduct material. The 

current regulations limit AUs, AMPs, 

and ANPs to serve as an RSO only on 

the license on which they are listed. 

The AUs, AMPs, and ANPs must meet 

the same requirements to serve as the 

RSO regardless of which Commission 

medical license they are identified on. 

Therefore, not allowing them to serve as 

an RSO on any Commission medical 

license is unnecessarily restrictive. This 

change will increase the number of 

individuals available to serve as RSOs 

and ARSOs on NRC medical licenses. 

Paragraph (c)(3). This new paragraph 

allows an individual who is not named 

as an AU on a medical use license or 

permit, but is qualified to be an AU, to 

be named simultaneously as the RSO 

and the AU on the same new medical 

license. Current regulations, under 

§ 35.50(c)(2), do not permit an 

individual who is not an AU on a 

license, but qualified to be an AU, to be 

an RSO. The individual must have the 

experience with the radiation safety 

aspects of the byproduct material for 

which the authorization is sought. An 

individual may meet the qualifications 

of an AU via the board certification or 

alternate pathway. An individual who 

uses the alternate pathway to be named 

simultaneously as the RSO and the AU 

on the same new medical use license 

must obtain a written attestation. 

The provision will provide flexibility 

for an individual to serve as both an AU 

and as the RSO on a new medical use 

license (a clinic or a medical institution) 

and may help to make medical 

procedures more widely available, 

especially in rural areas. 

Paragraph (d). This paragraph is 

amended to include ARSOs as 

individuals who can provide supervised 

training to an individual seeking 

recognition as an RSO or ARSO. 

Section 35.51 Training for an 

Authorized Medical Physicist 

Paragraph (a). The requirement for 

individuals seeking to be named as an 

AMP to obtain a written attestation is 

removed for those individuals who are 

certified by a specialty board whose 

certification process has been 

recognized by the NRC or an Agreement 

State. Further discussion on removing 

the written attestation requirement can 

be found in Section III, Discussion, of 

this document. 

Paragraph (a)(2)(i). This paragraph is 

amended to clarify that an AMP who 

provides supervision for meeting the 

requirements of this section must be 

certified in medical physics by a 

specialty board whose certification 

process has been recognized under this 

section by the Commission or an 

Agreement State. 

Current regulations allow a medical 

physicist with any board certification in 

diagnostic or therapeutic medical 

physics to serve as a supervising 

medical physicist in therapeutic 

procedures. The NRC believes that the 

supervision for therapeutic procedures 

must be provided by a therapy medical 

physicist who is certified in medical 

physics by a specialty board recognized 

under § 35.51 by the Commission or an 

Agreement State. 

Paragraph (b)(2). The wording in this 

paragraph is revised to remove the 

requirement for a written attestation that 

is required in § 35.51(a). It is also 

amended to incorporate the new 

language that the written attestation 

must verify that the individual is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently as an AMP. 

Section 35.55 Training for an 

Authorized Nuclear Pharmacist 

Paragraph (a). The requirement for 

individuals seeking to be named as an 

ANP to obtain a written attestation is 

removed for those individuals who are 

certified by a specialty board whose 

certification process has been 

recognized by the NRC or an Agreement 

State. 

Paragraph (b)(2). This paragraph is 

revised to conform to the removal of the 

attestation requirement in paragraph (a) 

of this section. It is also amended to 

incorporate the new language that the 

written attestation must verify that the 

individual is able to independently 

fulfill the radiation safety-related duties, 

rather than has achieved a level of 

competency to function independently 

as an ANP. 

Section 35.57 Training for 

Experienced Radiation Safety Officer, 

Teletherapy or Medical Physicist, 

Authorized Medical Physicist, 

Authorized User, Nuclear Pharmacist, 

and Authorized Nuclear Pharmacist 

Multiple changes are made to this 

section. Most of the changes are to the 

T&E requirements in response to the 

requested amendments in PRM–35–20. 

This includes recognizing the board 

certifications of individuals certified by 

boards recognized under subpart J, 

which was removed from 10 CFR part 

35 in a rulemaking dated March 30, 

2005 (70 FR 16336), and making 

administrative clarifications. Additional 

information on PRM–35–20, as it relates 

to this rulemaking, is located in Section 


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II., Petition for Rulemaking, PRM–35– 

20, of this document. 

Paragraph (a)(1). This paragraph is 

modified to add AMPs and ANPs. This 

paragraph is also modified to 

grandfather individuals listed in this 

paragraph who were identified on a 

license or permit on or before January 

14, 2019. These individuals will not 

need to comply with the applicable 

training requirements of §§ 35.50, 35.51, 

or 35.55. 

However, this paragraph is also 

modified such that RSOs and AMPs 

identified by this paragraph must meet 

the training requirements in §§ 35.50(d) 

or 35.51(c), as appropriate, for any 

materials or uses for which they were 

not authorized prior to the effective date 

of this rule. This is not a new training 

requirement. Current regulations require 

individuals qualifying under §§ 35.50 

and 35.51 as RSOs and AMPs to meet 

the training requirements in §§ 35.50(e) 

and 35.51(c). 

Paragraph (a)(2). This paragraph is 

amended 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. These 

individuals do not need to comply with 

the training requirements of § 35.50 to 

be identified as an RSO or as an ARSO 

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. 

Paragraph (a)(3). This paragraph is 

amended 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. These 

individuals do 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. These 

individuals are exempted from these 

training requirements only for those 

materials and uses these individuals 

performed on or before October, 24, 

2005. 

Paragraph (a)(4). This paragraph is 

renumbered from current paragraph 

(a)(3) and is not revised. 

Paragraph (b)(1). This paragraph is 

amended to change the date before 

which an individual is named on a 

license as an AU to be on or before 

January 14, 2019. 

Additionally, this paragraph is 

amended to clarify that an individual 

authorized on or before this date will 

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 the individual performed on or 

before January 14, 2019. 

Paragraph (b)(2). This paragraph is 

restructured and expanded to recognize 

a physician, dentist, or podiatrist who 

was certified by the named boards in the 

now-removed subpart J of 10 CFR part 

35 on or before October 24, 2005. These 

individuals do 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 

the individual performed on or before 

October 24, 2005. 

Section 35.65 Authorization for 

Calibration, Transmission, and 

Reference Sources 

This section is restructured and 

amended to include three new 

paragraphs. 

Paragraph (b)(1). This new paragraph 

requires that medical use of any 

byproduct material in sealed sources 

authorized by this section can only be 

used in accordance with the 

requirements in § 35.500. This is a 

clarification that all of the specified 

byproduct material for medical use must 

be under the supervision of an AU. 

Paragraph (b)(2). This new paragraph 

prohibits the bundling or aggregating of 

single-sealed sources to create a sealed 

source with an activity greater than 

authorized by § 35.65. 

Paragraph (c). This new paragraph 

clarifies that a licensee using 

calibration, transmission, and reference 

sources in accordance with the 

requirements in paragraphs (a) or (b) of 

this section need not list these sources 

on a specific medical use license. 

Section 35.190 Training for Uptake, 

Dilution, and Excretion Studies 

Paragraph (a). For a physician seeking 

to be named as an AU of unsealed 

byproduct material for uses authorized 

under § 35.100, the requirement to 

obtain a written attestation is removed 

for an individual who is certified by a 

specialty board whose certification 

process has been recognized by the NRC 

or an Agreement State. Further 

discussion on removing the written 

attestation requirement can be found in 

Section III., Discussion, of this 

document. 

Paragraph (c)(2). This paragraph is 

restructured and expanded to allow 

certain residency program directors to 

provide written attestations for a 

physician seeking to be named as an AU 

of unsealed byproduct material for uses 

authorized under § 35.100. The 

residency program director must 

represent a residency training program 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education, the 

Royal College of Physicians and 

Surgeons of Canada, or the Council on 

Postdoctoral Training of the American 

Osteopathic Association. The residency 

training program must include T&E 

specified in § 35.190. 

The residency program director who 

provides written attestations does not 

have to be an AU who meets the 

requirements in §§ 35.57, 35.190, 

35.290, or 35.390, or equivalent 

Agreement State requirements. 

However, the director must affirm in 

writing that the attestation represents 

the consensus of the residency program 

faculty where at least one faculty 

member is an AU who meets the 

requirements in §§ 35.57, 35.190, 

35.290, or 35.390, or equivalent 

Agreement State requirements, and that 

the AU concurs with the attestation. 

Additionally, the paragraph is 

amended to incorporate the new 

language that the written attestation 

must verify that the physician is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently as an AU. 

Section 35.204 Permissible 

Molybdenum-99, Strontium-82, and 

Strontium-85 Concentrations 

Paragraph (b). The current 

requirement to measure the Mo-99 

concentration only after the first eluate 

is changed to require that the Mo-99 

concentration be measured after each 

elution. A generator can be eluted 

several times to obtain Tc-99m for 

formulating radiopharmaceuticals for 

human use. Current regulations require 

licensees to measure the Mo-99 

concentration only the first time a 

generator is eluted. 

Paragraph (e). This new paragraph 

adds a requirement that licensees report 

any measurement that exceeds the 

limits specified in § 35.204(a) for Mo99/Tc-99m and Sr-82/Rb-82 generators 

at the time of generator elution. 

Further discussion on this issue can 

be found in Section III., Discussion, of 

this document. 

Section 35.290 Training for Imaging 

and Localization Studies 

Paragraph (a). For physicians seeking 

to be named as an AU of unsealed 

byproduct material for uses authorized 

under § 35.200, the requirement to 

obtain a written attestation is removed 

for those individuals who are certified 

by a specialty board whose certification 


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process has been recognized by the NRC 

or an Agreement State. Further 

discussion on removing the written 

attestation requirement can be found in 

Section III., Discussion, of this 

document. 

Paragraph (c)(1)(ii). This paragraph is 

amended to allow an ANP who meets 

the requirements in §§ 35.55 or 35.57 to 

provide the supervised work experience 

specified in paragraph (c)(1)(ii)(G) of 

this section for individuals seeking to be 

named as an AU of unsealed byproduct 

material for uses authorized under 

§ 35.200. Paragraph (c)(1)(ii)(G) of this 

section requires supervised work 

experience in eluting generator systems. 

Many medical facilities no longer elute 

generators and instead receive unit 

doses from centralized pharmacies; 

therefore, training on eluting generators 

is not available at these facilities. 

Authorized Nuclear Pharmacists have 

the T&E to provide the supervised work 

experience for AUs on the elution of 

generators. 

Paragraph (c)(2). This paragraph is 

restructured and expanded to allow 

certain residency program directors to 

provide written attestations for 

individuals seeking to be named as an 

AU of unsealed byproduct material for 

uses authorized under §§ 35.100 and 

35.200. The residency program director 

must represent a residency training 

program approved by the Residency 

Review Committee of the Accreditation 

Council for Graduate Medical 

Education, the Royal College of 

Physicians and Surgeons of Canada, or 

the Council on Postdoctoral Training of 

the American Osteopathic Association. 

The residency training program must 

include T&E specified in § 35.290. 

The residency program directors who 

provide written attestations do not have 

to be AUs who meet the requirements in 

§§ 35.57, 35.290, or 35.390 and 

35.290(c)(1)(ii)(G), or equivalent 

Agreement State requirements. 

However, they must affirm in writing 

that the attestation represents the 

consensus of the residency program 

faculty where at least one faculty 

member is an AU who meets the 

requirements in §§ 35.57, 35.290, or 

35.390 and 35.290(c)(1)(ii)(G) or 

equivalent Agreement State 

requirements, and that the AU concurs 

with the attestation. 

Additionally, the paragraph is 

amended to incorporate the new 

language that the written attestation 

must verify that the individual is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently as an AU. 

§ 35.300 Use of Unsealed Byproduct 

Material for Which a Written Directive Is 

Required 

The introductory paragraph is 

amended to clarify that a licensee may 

only use unsealed byproduct material 

identified in § 35.390(b)(1)(ii)(G) under 

this section. Currently, § 35.300 states 

that ‘‘A licensee may use any unsealed 

byproduct material. . . .’’ This change 

clarifies that a licensee’s authorization 

of the radiopharmaceuticals requiring a 

WD is only for those types of 

radiopharmaceuticals for which the AU 

has documented T&E. An AU may be 

authorized for one or all of the specific 

categories described in 

§ 35.390(b)(1)(ii)(G), but not for all 

unsealed byproduct material. 

Section 35.390 Training for Use of 

Unsealed Byproduct Material for Which 

a Written Directive Is Required 

Paragraph (a). For physicians seeking 

to be named as AUs of unsealed 

byproduct material for uses authorized 

under § 35.300, the requirement to 

obtain a written attestation is removed 

for those individuals who are certified 

by a specialty board whose certification 

process has been recognized by the NRC 

or an Agreement State. Further 

discussion on removing the written 

attestation requirement can be found in 

Section III., Discussion, of this 

document. 

Paragraph (b)(1)(ii)(G)(3). This 

paragraph is amended to identify a 

single category of parenteral 

administrations of radionuclides in 

which work experience is required for 

an individual seeking to be an AU for 

uses under § 35.300. 

The current regulations include a 

broad category for parenteral 

administrations of ‘‘any other’’ 

radionuclide. This broad category is 

removed, as any new parenteral 

administration of radionuclides not 

listed in this paragraph are regulated 

under § 35.1000. This approach will 

allow the NRC to review each new 

proposed radionuclide for parenteral 

administration and determine the 

appropriate T&E for its use. 

Current regulations require physicians 

requesting AU status for administering 

dosages of radioactive drugs to humans 

(including parenteral administration) to 

have work experience with a minimum 

of three cases in each category for which 

they are requesting AU status. This 

requirement is retained in the final rule 

with regard to all categories in this 

paragraph. 

Paragraph (b)(2). This paragraph is 

restructured and expanded to allow 

certain residency program directors to 

provide written attestations for 

physicians seeking to be named as AUs 

of unsealed byproduct material for uses 

authorized under § 35.300. The 

residency program director must 

represent a residency training program 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education or the 

Royal College of Physicians and 

Surgeons of Canada or the Council on 

Postdoctoral Training of the American 

Osteopathic Association. The residency 

training program must include T&E 

specified in § 35.300. 

The residency program directors who 

provide written attestations do not have 

to be AUs who meet the requirements in 

§§ 35.57, 35.390, or equivalent 

Agreement State requirements, or have 

experience in administering dosages in 

the same dosage category or categories 

as the individual requesting AU status. 

However, they must affirm in writing 

that the attestation represents the 

consensus of the residency program 

faculty where at least one faculty 

member is an AU who meets the 

requirements in §§ 35.57, 35.390, or 

equivalent Agreement State 

requirements, has experience in 

administering dosages in the same 

dosage category or categories as the 

physician requesting AU status, and 

concurs with the attestation. 

Additionally, this paragraph is 

amended to incorporate the new 

language that the written attestation 

must verify that the physician is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently as an AU. 

Section 35.392 Training 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) 

Paragraph (a). For physicians 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), the requirement to obtain a 

written attestation is removed for those 

individuals who are certified by a 

specialty board whose certification 

process has been recognized by the NRC 

or an Agreement State. Further 

discussion on removing the written 

attestation requirement can be found in 

Section III., Discussion, of this 

document. 

Paragraph (c)(3). This paragraph is 

restructured and expanded to allow 

certain residency program directors to 

provide written attestations for 

physicians seeking to be named as an 


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AU of unsealed byproduct material for 

the oral administration of sodium iodide 

I–131 requiring a WD in quantities less 

than or equal to 1.22 gigabecquerels (33 

millicuries) authorized under § 35.300. 

The residency program director must 

represent a residency training program 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education or the 

Royal College of Physicians and 

Surgeons of Canada or the Council on 

Postdoctoral Training of the American 

Osteopathic Association. The residency 

training program must include T&E 

specified in § 35.392. 

The residency program directors who 

provide written attestations do not have 

to be AUs who meet the requirements in 

§§ 35.57, 35.390, 35.392, 35.394, or 

equivalent Agreement State 

requirements, or have experience in 

administering dosages as specified in 

§ 35.390(b)(1)(ii)(G)(1) or 

35.390(b)(1)(ii)(G)(2). However, they 

must affirm in writing that the 

attestation represents the consensus of 

the residency program faculty where at 

least one faculty member is an AU who 

meets the requirements in §§ 35.57, 

35.390, 35.392, 35.394, or equivalent 

Agreement State requirements, has 

experience in administering dosages as 

specified in § 35.390(b)(1)(ii)(G)(1) or 

35.390(b)(1)(ii)(G)(2), and concurs with 

the attestation. 

Additionally, this paragraph is 

amended to incorporate the new 

language that the written attestation 

must verify that the physician is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently, as an AU. 

Section 35.394 Training for the Oral 

Administration of Sodium Iodide I–131 

Requiring a Written Directive in 

Quantities Greater Than 1.22 

Gigabecquerels (33 Millicuries) 

Paragraph (a). For physicians seeking 

to be named as an AU for the oral 

administration of sodium iodide I–131 

requiring a WD in quantities greater 

than 1.22 gigabecquerels (33 

millicuries), the requirement to obtain a 

written attestation is removed for those 

individuals who are certified by a 

specialty board whose certification 

process has been recognized by the NRC 

or an Agreement State. Further 

discussion on removing the written 

attestation requirement can be found in 

Section III., Discussion, of this 

document. 

Paragraph (c)(3). This paragraph is 

restructured and expanded to allow 

certain residency program directors to 

provide written attestations for 

physicians seeking to be named as an 

AU of unsealed byproduct material for 

the oral administration of sodium iodide 

I–131 requiring a WD in quantities 

greater than 1.22 gigabecquerels (33 

millicuries) authorized under § 35.300. 

The residency program director must 

represent a residency training program 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education or the 

Royal College of Physicians and 

Surgeons of Canada or the Council on 

Postdoctoral Training of the American 

Osteopathic Association. The residency 

training program must include T&E 

specified in § 35.394. 

The residency program directors who 

provide written attestations do not have 

to be AUs who meet the requirements in 

§§ 35.57, 35.390, 35.394, or equivalent 

Agreement State requirements, or have 

experience in administering dosages as 

specified in § 35.390(b)(1)(ii)(G)(2). 

However, they must affirm in writing 

that the attestation represents the 

consensus of the residency program 

faculty where at least one faculty 

member is an AU who meets the 

requirements in §§ 35.57, 35.390, 

35.394, or equivalent Agreement State 

requirements, has experience in 

administering dosages as specified in 

§ 35.390(b)(1)(ii)(G)(2), and concurs 

with the attestation. 

Additionally, the paragraph is 

amended to incorporate the new 

language that the written attestation 

must verify that the physician is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently as an AU. 

Section 35.396 Training for the 

Parenteral Administration of Unsealed 

Byproduct Material Requiring a Written 

Directive 

Amendments to this section include 

conforming changes to support the new 

single category for parenteral 

administration in 

§ 35.390(b)(1)(ii)(G)(3), changes to allow 

residency program directors to provide 

written attestations, and a change in the 

attestation language. Additionally, this 

section is restructured and renumbered 

to accommodate the changes. 

Paragraph (a). This paragraph was 

restructured to list the physicians who 

can seek AU status under paragraphs 

(a)(1), (2), and (3) that were previously 

listed as paragraphs (a), (b), and (c). 

Conforming changes are made to 

support the new single category for 

parenteral administration in 

§ 35.390(b)(1)(ii)(G)(3). 

Paragraph (b). This paragraph was 

restructured as paragraphs (b)(1), (2), 

and (3). These paragraphs describe the 

T&E required for physicians specified in 

§ 35.396(a)(2) and (a)(3). The provisions 

within these paragraphs were the 

previous paragraph (d) in the proposed 

rule. Conforming changes are made to 

support the new single category for 

parenteral administration in 

§ 35.390(b)(1)(ii)(G)(3). 

Paragraph (b)(3). This paragraph is 

further restructured and expanded to 

allow certain residency program 

directors to provide written attestations 

for physicians seeking to be named as 

an AU of unsealed byproduct material 

for the parenteral administration 

requiring a WD. The residency program 

director must represent a residency 

training program approved by the 

Residency Review Committee of the 

Accreditation Council for Graduate 

Medical Education or the Royal College 

of Physicians and Surgeons of Canada or 

the Council on Postdoctoral Training of 

the American Osteopathic Association. 

The residency training program must 

include T&E specified in § 35.396. 

The residency program directors who 

provide written attestations do not have 

to be AUs who meet the requirements in 

§§ 35.57, 35.390, 35.396, or equivalent 

Agreement State requirements, or have 

experience in administering dosages in 

the same category as the individual 

requesting AU status. However, they 

must affirm in writing that the 

attestation represents the consensus of 

the residency program faculty where at 

least one faculty member is an AU who 

meets the requirements in §§ 35.57, 

35.390, 35.396, or equivalent Agreement 

State requirements, and concurs with 

the attestation. An AU who meets the 

requirements in §§ 35.390, 35.396, or 

equivalent Agreement State 

requirements, must have experience in 

administering dosages in the same 

category as the individual requesting 

AU user status. 

Additionally, this paragraph is 

amended to incorporate the new 

language that the written attestation 

must verify that the physician is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently as an AU. 

Section 35.400 Use of Sources for 

Manual Brachytherapy 

This section is expanded to allow for 

sources that are listed in the SSDR for 

manual brachytherapy to be used for 

other manual brachytherapy uses that 

are not explicitly listed in the SSDR. 

Paragraph (a). This paragraph is 

amended to allow sources that are listed 

in the SSDR for manual brachytherapy 

medical uses to be used for manual 


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brachytherapy 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. These radiation safety 

conditions and limitations described in 

the SSDR may apply to storage, 

handling, sterilization, conditions of 

use, or leak testing of radiation sources. 

The NRC recognizes that the medical 

uses specified in the SSDR may not be 

all-inclusive. The final rule will permit 

physicians to use manual brachytherapy 

sources to treat sites or diseases not 

listed in the SSDR. For example, the 

SSDR may specify that the sources are 

for interstitial uses, but the final rule 

change allows the physician to use the 

sources for a topical use. The NRC has 

determined this flexibility should be 

afforded to physicians to use their 

discretion in the practice of medicine. 

Section 35.433 Strontium-90 Sources 

for Ophthalmic Treatments 

This section title is modified by 

deleting ‘‘Decay of’’ at the beginning of 

the title. This new title reflects the 

expanded information and requirements 

in this section. 

Paragraph (a). This paragraph is 

amended and expanded to allow certain 

individuals who are not AMPs to 

calculate the activity of strontium-90 

(Sr-90) sources that is used to determine 

the treatment times for ophthalmic 

treatments. These individuals, defined 

in § 35.2 as ophthalmic physicists, must 

meet the T&E requirements detailed in 

the new paragraph (a)(2) of this section 

to perform the specified activities. A 

written attestation will not be required. 

These requirements are similar to the 

T&E requirements for an AMP, but 

include only the requirements related to 

brachytherapy programs. 

Paragraph (b). This new paragraph 

establishes the tasks that individuals 

qualified under paragraph (a) of this 

section are required to perform in 

supporting ophthalmic treatments with 

Sr-90. The first task is based upon the 

requirements in § 35.432 for calculating 

the activity of each Sr-90 source used 

for ophthalmic treatments. This is not a 

new requirement, as it is required in the 

current regulation under § 35.433(a). 

The second task is related to the 

requirements in § 35.41 and is included 

in this final rule to ensure the safe use 

of Sr-90 for ophthalmic treatments. Both 

the AMP and the ophthalmic physicist 

are required to assist the licensee in 

developing, implementing, and 

maintaining written procedures to 

provide high confidence that the dose 

administration is in accordance with the 

WD. Under this paragraph, the licensee 

must modify its procedures required 

under § 35.41 to specify the frequencies 

at which the AMP or the ophthalmic 

physicist will observe treatments, 

review the treatment methodology, 

calculate treatment time for the 

prescribed dose, and review records to 

verify that the treatment was 

administered in accordance with the 

WD. 

Paragraph (c). This paragraph is a 

designation of the recordkeeping 

requirements in the current regulation 

under § 35.433(b). The requirements 

have not changed. 

Section 35.490 Training for Use of 

Manual Brachytherapy Sources 

Paragraph (a). For a physician seeking 

to be named as an AU of a manual 

brachytherapy source for the uses 

authorized under § 35.400, the 

requirement to obtain a written 

attestation is removed for an individual 

who is certified by a specialty board 

whose certification process has been 

recognized by the NRC or an Agreement 

State. Further discussion on removing 

the written attestation requirement can 

be found in Section III., Discussion, of 

this document. 

Paragraph (b)(1)(ii). This paragraph is 

amended to require that the work 

experience required by this section must 

be received at a medical facility 

authorized to use byproduct materials 

under § 35.400 rather than at a medical 

institution. The current term ‘‘medical 

institution’’ in this paragraph is defined 

in § 35.2 as an organization in which 

more than one medical discipline is 

practiced. This definition unnecessarily 

limits where the work experience must 

be obtained. Moreover, the fact that an 

organization practices more than one 

medical discipline does not ensure that 

one of the medical disciplines is related 

to uses authorized under § 35.400. The 

change will allow individuals to receive 

work experience at a stand-alone, 

single-discipline clinic and ensure that 

the work experience is related to the 

uses authorized under § 35.400. 

Paragraph (b)(3). This paragraph is 

restructured and expanded to allow 

certain residency program directors to 

provide written attestations for 

physicians seeking to be named as an 

AU of a manual brachytherapy source 

for the uses authorized under § 35.400. 

The residency program directors must 

represent a residency training program 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education or the 

Royal College of Physicians and 

Surgeons of Canada or the Council on 

Postdoctoral Training of the American 

Osteopathic Association. The residency 

training program must include T&E 

specified in § 35.400. 

The residency program directors who 

provide written attestations do not have 

to be AUs who meet the requirements in 

§§ 35.57, 35.490, or equivalent 

Agreement State requirements. 

However, they must affirm in writing 

that the attestation represents the 

consensus of the residency program 

faculty where at least one faculty 

member is an AU who meets the 

requirements in §§ 35.57, 35.490, or 

equivalent Agreement State 

requirements, and concurs with the 

attestation. 

Additionally, the paragraph is 

amended to incorporate the new 

language that the written attestation 

must verify that the physician is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently as an AU. 

Section 35.491 Training for 

Ophthalmic Use of Strontium-90 

Paragraph (b)(3). This paragraph is 

amended to incorporate the new 

language that the written attestation 

must verify that the physician is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently as an AU. 

Section 35.500 Use of Sealed Sources 

and Medical Devices for Diagnosis 

This section is restructured and 

expanded to include the use of medical 

devices to allow sealed sources and 

medical devices that are listed in the 

SSDR for diagnostic medical uses to be 

used for diagnostic medical uses that are 

not explicitly listed in the SSDR, and to 

allow sealed sources and medical 

devices to be used in research in 

accordance with an active 

Investigational Device Exemption (IDE) 

application accepted by the FDA. This 

section title is modified to add ‘‘and 

medical devices’’ because the use of 

medical devices is added to this section. 

Paragraph (a). This paragraph is 

amended to clarify that sealed sources 

that are not in medical devices for 

diagnostic medical uses and that are 

approved in the SSDR can be used for 

other diagnostic medical uses that are 

not explicitly listed in an SSDR 

provided that the sealed sources are 

used in accordance with radiation safety 

conditions and limitations described in 

the SSDR. These radiation safety 

conditions and limitations described in 

the SSDR may include storage, 

handling, sterilization, conditions of 

use, or leak testing of radiation sources. 


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Paragraph (b). This paragraph is 

added to allow medical devices 

containing sealed sources to be used for 

diagnostic medical uses that are not 

explicitly listed in an SSDR if both the 

sealed sources and the medical devices 

are approved in the SSDR for diagnostic 

medical uses and provided that the 

medical devices are used in accordance 

with radiation safety conditions and 

limitations described in the SSDR. 

These radiation safety conditions and 

limitations described in the SSDR may 

include storage, handling, sterilization, 

conditions of use, and leak testing of 

radiation sources. 

Paragraph (c). This new paragraph 

allows sealed sources and devices for 

diagnostic medical uses to be used in 

research in accordance with an active 

IDE application accepted by the FDA, 

provided the requirements of § 35.49(a) 

are met. 

Section 35.590 Training for Use of 

Sealed Sources and Medical Devices for 

Diagnosis 

This section is restructured and 

expanded to clarify that both diagnostic 

sealed sources and devices authorized 

in § 35.500 are included in the T&E 

requirements of this section. 

Paragraph (a). This paragraph is 

revised to reference the redesignated 

paragraphs (c) and (d). 

Paragraph (b). This new paragraph 

recognizes the individuals who are 

authorized for uses listed in § 35.200, or 

equivalent Agreement State 

requirements, for use of diagnostic 

sealed sources or devices authorized 

under § 35.500. 

Section 35.600 Use of a Sealed Source 

in a Remote Afterloader Unit, 

Teletherapy Unit, or Gamma 

Stereotactic Radiosurgery Unit 

This section is amended to separate 

the uses of photon-emitting remote 

afterloader units, teletherapy units, or 

gamma stereotactic radiosurgery units 

from the uses of the sealed sources 

contained within these units. The 

amended section allows only sealed 

sources approved in the SSDR in 

devices to deliver therapeutic medical 

treatments as provided for in the SSDR. 

However, the units containing these 

sources can be used for therapeutic 

medical treatments that are not 

explicitly provided for in the SSDR, 

provided that they are used in 

accordance with radiation safety 

conditions and limitations described in 

the SSDR. The purpose of this 

amendment is to allow physicians 

flexibility to exercise their medical 

judgment and to use these devices for 

new therapeutic treatments that may not 

have been anticipated when the devices 

were registered. 

Paragraph (a). This paragraph 

requires that a licensee use only sealed 

sources approved in the SSDR for 

therapeutic medical uses in photonemitting remote afterloader units, 

teletherapy units, or gamma stereotactic 

radiosurgery units as provided for in the 

SSDR or for research in accordance with 

an active IDE application accepted by 

the FDA, provided the requirements of 

§ 35.49(a) are met. 

Paragraph (b). This paragraph 

continues to require that a licensee only 

use photon emitting remote afterloader 

units, teletherapy units, or gamma 

stereotactic radiosurgery units approved 

in the SSDR or for research in 

accordance with an active IDE 

application accepted by the FDA 

provided the requirements of § 35.49(a) 

are met. However, this paragraph is 

amended to provide that these units 

may be used for medical uses that are 

not explicitly provided for in the SSDR, 

provided that these units are used in 

accordance with the radiation safety 

conditions and limitations described in 

the SSDR. 

Section 35.610 Safety Procedures and 

Instructions for Remote Afterloader 

Units, Teletherapy Units, and Gamma 

Stereotactic Radiosurgery Units 

Paragraph (d)(1). This paragraph is 

amended and restructured to add a new 

training requirement for the use of 

remote afterloader units, teletherapy 

units, and gamma stereotactic 

radiosurgery units. This amendment 

requires all individuals who 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. This 

training must be provided by the device 

manufacturer or by an individual 

certified by the device manufacturer to 

provide the training. This training is 

also required when software upgrades 

are made by the vendor or the 

manufacturer that affect the operation 

and safety of the unit. 

Currently, § 35.610(d) requires that all 

individuals who operate these units be 

provided safety instructions initially, 

and at least annually; however, there is 

no requirement for these individuals to 

receive instructions when the unit is 

upgraded. The amendment requires 

individuals who operate these new or 

upgraded units to receive training prior 

to first use for patient treatment. These 

individuals include AUs, AMPs, 

operators, and others that need to know 

how the units operate. 

Paragraph (d)(2). This paragraph is 

restructured and amended to clarify that 

the training required by this paragraph 

on the operation and safety of the unit 

applies to any new staff who will 

operate the unit or units at the facility. 

This requirement is added to enhance 

the safety of patients by eliminating 

potential delay in training of new staff 

until the required annual training, 

which could lead to undertrained 

individuals operating the unit. 

Paragraph (g). This paragraph is 

amended to conform with the 

restructuring of paragraph (d)(2) of this 

section. 

Section 35.655 Full-Inspection 

Servicing for Teletherapy and Gamma 

Stereotactic Radiosurgery Units 

This section title is modified to delete 

‘‘5-year inspection’’ and insert ‘‘Fullinspection servicing’’ to more accurately 

reflect the requirements in this section 

for inspection and servicing of 

teletherapy units and gamma 

stereotactic radiosurgery units. 

Paragraph (a). This paragraph is 

amended to extend the full inspection 

and servicing interval between each full 

inspection servicing for gamma 

stereotactic radiosurgery units from 5 

years to 7 years to assure proper 

functioning of the source exposure 

mechanism. The interval between each 

full inspection and servicing of 

teletherapy units remains the same (not 

to exceed 5 years). For gamma 

stereotactic radiosurgery units, the full 

inspection and servicing to assure 

proper functioning of the source 

exposure mechanism is performed when 

the sources are taken out of the unit and 

before the new sources are placed in the 

unit (source replacement). Because the 

cost to replace the decaying sources in 

a gamma stereotactic radiosurgery unit 

can be significant, licensees have 

requested that the intervals between 

each full inspection servicing for these 

units be extended beyond 5 years. In 

support of this extension, the NRC finds 

that the 6-month routine preventive 

maintenance that is performed on these 

units is adequate to ensure the proper 

functioning of the source exposure 

mechanisms and, therefore, this final 

rule extends the full inspection and 

servicing interval for gamma stereotactic 

radiosurgery units from 5 years to 7 

years. 

Additionally, this paragraph requires 

that the full inspection and servicing of 

these units be performed during each 

source replacement regardless of the last 

time the units were inspected and 

serviced. 

The full inspection and servicing 

interval of a teletherapy unit has not 


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been extended from the current interval 

of 5 years. The current interval of 5 

years helps prevent potentially serious 

radiation exposure of teletherapy 

operators and patients in the event that 

the source exposure mechanism fails. 

The radioactive source contained in a 

teletherapy unit produces radiation 

fields on the order of hundreds of rads 

per minute in areas accessible to 

patients and operators. In the event of 

a source exposure mechanism failure, 

the exposed source could result in 

overexposure of a patient or operating 

personnel in a short period of time. 

Section 35.690 Training for Use of 

Remote Afterloader Units, Teletherapy 

Units, and Gamma Stereotactic 

Radiosurgery Units 

Paragraph (a). For a physician seeking 

to be named as an AU for sealed sources 

for uses authorized under § 35.600, the 

requirement to obtain a written 

attestation is removed for an individual 

who is certified by a specialty board 

whose certification process has been 

recognized by the NRC or an Agreement 

State. Further discussion on removing 

the written attestation requirement can 

be found in Section III., Discussion, of 

this document. 

Paragraph (b)(1)(ii). This paragraph is 

amended to require that the work 

experience required by this section be 

received at a medical facility authorized 

to use byproduct materials under 

§ 35.600 rather than at a medical 

institution. The current term ‘‘medical 

institution’’ in this paragraph is defined 

in § 35.2 as an organization in which 

more than one medical discipline is 

practiced. This definition unnecessarily 

limits where the work experience must 

be obtained. Moreover, the fact that an 

organization practices more than one 

medical discipline does not ensure that 

one of the medical disciplines is related 

to uses authorized under § 35.600. The 

change allows the work experience to be 

received at a stand-alone single 

discipline clinic for the uses authorized 

under § 35.600. 

Paragraph (b)(3). This paragraph is 

restructured and expanded to allow 

certain residency program directors to 

provide written attestations for 

physicians seeking to be named as an 

AU for sealed sources for uses 

authorized under § 35.600. The 

residency program directors must 

represent a residency training program 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education, the 

Royal College of Physicians and 

Surgeons of Canada, or the Council on 

Postdoctoral Training of the American 

Osteopathic Association. The residency 

training program must include T&E 

specified in § 35.690. 

The residency program directors who 

provide written attestations do not have 

to be AUs who meet the requirements in 

§§ 35.57, 35.690, or equivalent 

Agreement State requirements, for the 

type(s) of therapeutic medical unit(s) for 

which the individual is requesting AU 

status. However, they must affirm in 

writing that the attestation represents 

the consensus of the residency program 

faculty where at least one faculty 

member is an AU who meets the 

requirements in §§ 35.57, 35.690, or 

equivalent Agreement State 

requirements, for the type(s) of 

therapeutic medical unit(s) for which 

the individual is requesting AU status 

and concurs with the attestation. 

Additionally, this paragraph is 

amended to incorporate the new 

language that the written attestation 

must verify that the physician is able to 

independently fulfill the radiation 

safety-related duties, rather than has 

achieved a level of competency to 

function independently as an AU. 

Section 35.2024 Records of Authority 

and Responsibilities for Radiation 

Protection Programs 

Paragraph (c). This new paragraph 

requires the licensee to keep records of 

each ARSO assigned under § 35.24(b) 

for 5 years after the ARSO is removed 

from the license. This record must 

include the written document 

appointing the ARSO signed by the 

licensee’s management. 

Section 35.2310 Records of Safety 

Instruction 

This section is amended to conform to 

the changes made in § 35.610 by adding 

a requirement to maintain the 

operational and safety instructions 

required by § 35.610. 

Section 35.2655 Records of FullInspection Servicing for Teletherapy 

and Gamma Stereotactic Radiosurgery 

Units 

This section title is modified to delete 

‘‘5-year inspection’’ and insert ‘‘fullinspection servicing’’ to reflect the 

changes to § 35.655 requiring full 

inspection and servicing of teletherapy 

units and gamma stereotactic 

radiosurgery units. 

Section 35.3045 Report and 

Notification of a Medical Event 

Paragraph (a). This paragraph is 

restructured and amended to provide 

separate specific criteria for reporting an 

ME involving permanent implant 

brachytherapy. These new criteria are 

different from the criteria for reporting 

an ME for other administrations. The 

paragraph retains the current 

introductory sentence, ‘‘A licensee shall 

report any event as a medical event, 

except for an event that results from 

patient intervention. . .’’ The 

introductory sentence of § 35.3045(a), 

published in the proposed rule in July 

21, 2014, provided that ‘‘A licensee 

shall report as a medical event, any 

administration requiring a written 

directive, except for an event that 

results from patient intervention. . . .’’ 

The phrase ‘‘requiring a written 

directive’’ is removed from this sentence 

in the final rule. This revision in the 

final rule maintains the current 

requirement that all events that meet the 

ME criteria be reported, not just those 

that require a WD. 

Paragraph (a)(1). This new paragraph 

contains criteria for reporting an ME for 

all administrations other than 

permanent implant brachytherapy 

administrations. Criteria for reporting an 

ME involving permanent implant 

brachytherapy are in the new paragraph 

(a)(2) in this section. The criteria used 

to determine if an ME has occurred for 

all administrations, except permanent 

implant brachytherapy, are unchanged 

except (1) the current paragraph (a)(3) 

related to the dose to the skin or an 

organ or tissue other than the treatment 

site is restructured for clarity as the new 

paragraph (a)(1)(iii); and (2) a criterion 

is added in the new paragraph 

(a)(1)(ii)(A) of this section for reporting 

an administration involving the wrong 

radionuclide for a brachytherapy 

procedure as an ME. 

Paragraph (a)(2). This new paragraph 

is added to establish separate criteria for 

reporting MEs involving permanent 

implant brachytherapy. These new 

criteria are designed to ensure reporting 

of situations where harm or potential 

harm to the patient may occur. The new 

criteria for reporting an ME involving 

permanent implant brachytherapy are: 

(1) The total source strength 

administered differs by 20 percent or 

more from the total source strength 

documented in the post-implantation 

portion of the WD. An example of a 

situation that meets this criterion is a 

situation in which the sealed sources 

that were implanted had a different 

source strength than what was intended. 

This situation could occur because the 

licensee ordered, or the vendor shipped, 

sealed sources with the wrong activity; 

(2) The total source strength 

administered outside of the treatment 

site exceeds 20 percent of the total 

source strength documented in the postimplantation portion of the WD. An 

example of a situation that meets this 

criterion is a situation in which the 


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sealed sources are unintentionally 

implanted outside of the treatment site. 

This situation would be identified by 

the licensee when determinations are 

made pursuant to § 35.41; 

(3) An administration that includes 

the wrong radionuclide; the wrong 

individual or human research subject; 

sealed source, or sources, implanted 

directly into a location discontiguous 

from the treatment site, as documented 

in the post-implantation portion of the 

WD; or a leaking sealed source resulting 

in a dose that exceeds 0.5 Sv (50 rem) 

to an organ or tissue. Only the criteria 

for a leaking sealed source retains the 

dose threshold in current regulations 

because the NRC determined the leaking 

sealed source delivering a dose below 

this threshold does not need to be 

reported as an ME. Several situations 

that will meet this criterion are selfevident, i.e., the wrong patient, the 

wrong treatment site, or a leaking sealed 

source. Three criteria published in the 

proposed rule on July 21, 2014, have 

been deleted in the final rule: (1) The 

criterion related to absorbed dose to the 

maximally exposed 5 contiguous cubic 

centimeters of normal tissue located 

outside the treatment site; (2) the 

criterion related to absorbed dose to the 

maximally exposed 5 contiguous cubic 

centimeters of normal tissue located 

within the treatment site; and (3) the 

criterion related to an error of 20 

percent or more in calculating the total 

source strength. These deletions are 

based on the comments received on the 

proposed rule and is discussed in 

Section V., Public Comment Analysis, of 

this document. 

Section 35.3204 Report and 

Notification for an Eluate Exceeding 

Permissible Molybdenum-99, Strontium82, and Strontium-85 Concentrations 

This new section requires reporting 

and notification of an elution from a 

Mo-99/Tc-99m or Sr-82/Rb-82 generator 

that exceeds the regulatory requirements 

in §§ 30.34 and 35.204(a). Further 

discussion of this requirement can be 

found in Section III., Discussion, of this 

document. 

Paragraph (a). This new paragraph 

requires a licensee to notify both the 

NRC Operations Center and the 

distributor, which also may sometimes 

be the manufacturer, of the generator by 

telephone within 7 calendar days after 

discovery that an eluate exceeds the 

permissible concentration listed in 

§ 35.204(a). This notification must 

include the manufacturer, model 

number, and serial number (or lot 

number) of the generator; the results of 

the measurement; the date of the 

measurement; whether dosages were 

administered to patients or human 

research subjects; when the distributor 

was notified; and the action taken. 

Paragraph (b). This new paragraph 

requires a licensee to submit a written 

report to the appropriate NRC Regional 

Office listed in § 30.6 within 30 

calendar days after discovery of an 

eluate exceeding the permissible 

concentration at the time of generator 

elution. The report must be submitted 

by an appropriate method listed in 

§ 30.6(a). The report must include the 

action taken by the licensee; patient 

dose assessments; the methodology used 

in making the patient dose assessment 

if the eluate was administered to 

patients or human research subjects; 

probable cause and assessment of failure 

in the licensee’s equipment; procedures 

or training that contributed to the 

excessive readings if an error occurred 

in the licensee’s breakthrough 

determination; and the information in 

the telephone report as required by 

paragraph (a) of this section. 

VII. Regulatory Flexibility Certification 

Under the Regulatory Flexibility Act 

(5 U.S.C. 605(b)), the NRC certifies that 

this rule will not, if promulgated, have 

a significant economic impact on a 

substantial number of small entities. 

This final rule affects a number of 

‘‘small entities’’ as defined by the 

Regulatory Flexibility Act or the size 

standards established by the NRC 

(§ 2.810). However, as indicated in the 

regulatory analysis available as 

indicated in Section XXIII, ‘‘Availability 

of Documents’’ section of this 

document, these amendments do not 

have a significant economic impact on 

the affected small entities. The NRC 

requested comment on the proposed 

rule and accompanying draft regulatory 

analysis on the impact of the proposed 

rule on small entities. The NRC received 

no comment submissions from an 

identified small entity. 

VIII. Regulatory Analysis 

The NRC has prepared a final 

regulatory analysis on this regulation. 

The regulatory analysis examines the 

costs and benefits of the alternatives 

considered by the NRC. The regulatory 

analysis is available as indicated in 

Section XXIII., Availability of 

Documents, of this document. 

IX. Backfitting and Issue Finality 

The backfit rule and issue finality 

provisions of 10 CFR part 52 (which are 

found in the regulations at §§ 50.109, 

70.76, 72.62, 76.76, and in 10 CFR part 

52) do not apply to this final rule. Parts 

30, 32, and 35 of 10 CFR do not contain 

a backfitting provision. Therefore, a 

backfitting analysis is not required. 

X. Cumulative Effects of Regulation 

Cumulative effects of regulation (CER) 

describes the challenges that licensees, 

certificate holders, States, or other 

entities may encounter while 

implementing new regulatory 

requirements (e.g., rules, generic letters, 

orders, inspection findings). The CER is 

an organizational effectiveness 

challenge that results from a licensee or 

impacted entity implementing a 

significant number of new and complex 

regulatory actions stemming from 

multiple regulatory actions, within a 

limited implementation period and with 

available resources (which may include 

limited available expertise to address a 

specific issue). The CER can potentially 

distract licensee or entity staff from 

executing other primary duties that 

ensure safety or security. The NRC 

specifically requested comments on the 

cumulative effects of this rulemaking in 

the proposed rule published on July 21, 

2014, and received three comments on 

the CER. Two Agreement States stated 

that with steady accretion of 

regulations, there are always 

unintended consequences, in that the 

additional costs impact decisions on 

functions of the State radiation control 

program. With regard to the NRC’s cost/ 

benefit analysis in the draft Regulatory 

Analysis, these commenters stated that 

the NRC’s cost/benefit analysis 

appeared to support the rule. One of the 

commenters expressed concern that 

there is the potential for applying rules 

in a manner in which they were not 

intended based on the permanent 

implant brachytherapy language in 

§ 35.40(b)(6). The commenter was 

concerned about the specification of 

dose to the normal tissues, located 

within the treatment site, in the 

proposed rule in § 35.40(b)(6)(i). Based 

on these comments and other public 

comments, § 35.40(b)(6)(i) in the final 

rule does not require the AU to specify 

dose to the normal tissues located 

within the treatment site. The comments 

are discussed in Section V., Public 

Comment Analysis, of this document. 

XI. Plain Writing 

The Plain Writing Act of 2010 (Pub. 

L. 111–274) requires Federal agencies to 

write documents in a clear, concise, and 

well-organized manner. The NRC has 

written this document to be consistent 

with the Plain Writing Act as well as the 

Presidential Memorandum, ‘‘Plain 

Language in Government Writing,’’ 

published June 10, 1998 (63 FR 31883). 


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XII. Environmental Impact: Categorical 

Exclusion 

The NRC has determined that the 

following actions in this final rule are 

the types of actions described in 

categorical exclusions in § 51.22(c)(2) 

and (c)(3)(i–v): 

(1) The amendments to the general 

administrative requirements and general 

technical requirements meet the 

categorical exclusion criteria under 

§ 51.22(c)(2). 

(2) The amendments to sealed sources 

usage provide clarifications to the 

current regulations and meet the 

categorical exclusion criteria under 

§ 51.22(c)(2). 

(3) The amendments to the 

requirements for reporting MEs and 

reporting failed generator tests meet the 

categorical exclusion criteria under 

§ 51.22(c)(3)(iii). 

(4) The amendments related to the 

record-keeping requirements meet the 

categorical exclusion criteria under 

§ 51.22(c)(3)(ii). 

(5) The amendments related to the 

T&E requirements meet the categorical 

exclusion criteria under 

§ 51.22(c)(3)(iv). 

There are two amendments that do 

not meet the categorical exclusion 

criteria in § 51.22. Therefore, an 

environmental assessment has been 

prepared for this rule for the two 

amendments that do not meet the 

categorical exclusion criteria in § 51.22. 

The environmental assessment is 

discussed in Section XIII., 

Environmental Assessment and Final 

Finding of No Significant 

Environmental Impact, of this 

document. The amendments that do not 

meet the categorical exclusions in 

§ 51.22 are: (1) The increase in the 

frequency of Mo–99 measurement tests 

required in § 35.204, and (2) the 

increase in the full inspection time 

interval for a gamma stereotactic 

radiosurgery unit from 5 years to 7 years 

in § 35.655. 

XIII. Environmental Assessment and 

Final Finding of No Significant 

Environmental Impact 

The Commission has determined 

under the National Environmental 

Policy Act of 1969, as amended, and the 

NRC’s regulations in Subpart A of 10 

CFR part 51, that this rule, if adopted, 

would not be a major Federal action 

significantly affecting the quality of the 

human environment and; therefore, an 

environmental impact statement is not 

required. The amendments that were the 

subject of the Environmental 

Assessment establish more frequent 

measuring of Mo–99 and increase the 

inspection interval for a gamma 

stereotactic radiosurgery unit from 5 

years to 7 years. The amendments are 

procedural in nature. It is expected that 

this rule will not cause any significant 

increase in radiation exposure to the 

public or radiation release to the 

environment beyond the exposures or 

releases currently resulting from the 

medical use of byproduct material. 

The NRC requested the views of the 

States and State Liaison Officers on the 

environmental assessment for this rule. 

The NRC did not receive any comments 

on the environmental assessment from 

the States or State Liaison Officers. 

The determination of the 

environmental assessment is that this 

rule would have no significant impact 

on the quality of the human 

environment. The environmental 

assessment is available as indicated in 

Section XXIII, Availability of 

Documents, of this document. 

XIV. Paperwork Reduction Act 

Statement 

This final rule contains new or 

amended collections of information 

subject to the Paperwork Reduction Act 

of 1995 (44 U.S.C. 3501 et seq.). The 

collections of information were 

approved by the Office of Management 

and Budget, control number 3150–0010. 

The burden to the public for the 

information collection(s) is estimated to 

average 2.52 hours per response, 

including the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the information collection. 

The information collection is being 

conducted to provide the NRC the 

information it needs to effectively 

evaluate license applications, 

applications for amendments, licensee 

operations, and significant safety events 

for protection of public health and 

safety. The information will be used by 

the NRC in evaluating compliance with 

licensing requirements. The NRC will 

assess the adequacy of an applicant’s or 

licensee’s physical location, equipment, 

organization, training, experience, 

procedures and plans for protection of 

public health and safety. The NRC 

review and the findings derived there 

form the basis of NRC licensing and 

inspection decisions. The NRC uses 

reports of significant safety events in 

evaluating the protective actions 

required to avoid exposures to patients 

and the public that could exceed 

regulatory limits, and therefore impact 

public health and safety and the 

environment. Responses to the 

information collection requirements at 

§§ 32.72 and 35.12 are mandatory or are 

required to obtain or retain a benefit. All 

other information collection 

requirements in this final rule are 

mandatory. Section 161b of the AEA 

authorizes the NRC to impose these 

information collections. 

You may submit comments on any 

aspect of the information collection(s), 

including suggestions for reducing the 

burden, by the following methods: 

• Federal rulemaking Website: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2008–0175. 

• Mail comments to: FOIA, Privacy, 

and Information Collections Branch, 

Office of Information Services, Mail 

Stop: T–5 F53, U.S. Nuclear Regulatory 

Commission, Washington, DC 20555– 

0001 or to Matthew Oreska, Desk 

Officer, Office of Information and 

Regulatory Affairs (3150–0010), NEOB– 

10202, Office of Management and 

Budget, Washington, DC 20503; 

telephone: 202–395–9593, email: oira_

submission@omb.eop.gov. 

Public Protection Notification 

The NRC may not conduct or sponsor, 

and a person is not required to respond 

to, a request for information or an 

information collection requirement 

unless the requesting document 

displays a currently valid OMB control 

number. 

XV. Congressional Review Act 

This final rule is a rule as defined in 

the Congressional Review Act (5. U.S.C. 

801–808). However, the Office of 

Management and Budget has not found 

it to be a major rule as defined in the 

Congressional Review Act. 

XVI. Criminal Penalties 

For the purpose of Section 223 of the 

Atomic Energy Act of 1954, as amended 

(AEA), the NRC is issuing this final rule 

that amends 10 CFR parts 30, 32, and 35 

under one or more of Sections 161b, 

161i, or 161o of the AEA. Willful 

violations of the rule will be subject to 

criminal enforcement. 

XVII. Coordination With NRC 

Agreement States 

The NRC has coordinated with the 

Agreement States throughout the 

development of this final rule. 

Agreement State representatives have 

served on the rulemaking working group 

that developed the proposed and final 

amendments to 10 CFR part 35 and on 

the steering committee for the 

rulemaking. 

Through an All Agreement State 

Letter (FSME–11–044, dated May 20, 

2011), the Agreement States were 

notified of the availability of 

preliminary rule text for comments 


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Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Rules and Regulations 33095 

posted on www.regulations.gov and 

noticed in the Federal Register (76 FR 

29171; May 20, 2011). The Federal 

Register notice also invited the 

Agreement States to participate at the 

two public workshops that were held in 

New York City, New York, and Houston, 

Texas, during the summer of 2011. 

In February 2013, the NRC provided 

the preliminary draft proposed rule to 

the Agreement States for a 30-day 

review. The Agreement States provided 

comments on the preliminary draft 

proposed rule. Several comments 

resulted in revisions to the discussion 

section of the proposed rule to provide 

additional emphasis or clarity. A 

summary of the Agreement States 

comments and the NRC staff responses 

to the comments is contained in 

Enclosure 6 to SECY–13–0084. 

Through an All Agreement State 

Letter (FSME–14–078, dated August 15, 

2014), the Agreement States were 

notified of the availability of the 

proposed rule noticed in the Federal 

Register (79 FR 42410; July 21, 2014). 

The Agreement States also had an 

opportunity to comment on the draft 

final rule. In preparing both the 

proposed rule and the final rule, the 

rulemaking working group considered 

the comments provided by the 

Agreement States. 

XVIII. Agreement State Compatibility 

Under the ‘‘Policy Statement on 

Adequacy and Compatibility of 

Agreement State Programs’’ approved by 

the Commission on June 30, 1997, and 

published in the Federal Register on 

September 3, 1997 (62 FR 46517), NRC 

program elements (including 

regulations) are placed into 

Compatibility Categories A, B, C, D, 

NRC, or adequacy category Health and 

Safety (H&S). Compatibility Category A 

are those program elements that are 

basic radiation protection standards and 

scientific terms and definitions that are 

necessary to understand radiation 

protection concepts. An Agreement 

State should adopt Category A program 

elements in an essentially identical 

manner in order to provide uniformity 

in the regulation of agreement material 

on a nationwide basis. Compatibility 

Category B are those program elements 

that apply to activities that have direct 

and significant effects in multiple 

jurisdictions. An Agreement State 

should adopt Category B program 

elements in an essentially identical 

manner. Compatibility Category C are 

those program elements that do not 

meet the criteria of Category A or B, but 

the essential objectives of which an 

Agreement State should adopt to avoid 

conflict, duplication, gaps, or other 

conditions that would jeopardize an 

orderly pattern in the regulation of 

agreement material on a national basis. 

An Agreement State should adopt the 

essential objectives of the Category C 

program elements. Compatibility 

Category D are those program elements 

that do not meet any of the criteria of 

Category A, B, or C, and, therefore do 

not need to be adopted by Agreement 

States for purposes of compatibility. 

Compatibility Category NRC are those 

program elements that address areas of 

regulation that cannot be relinquished 

to the Agreement States under the AEA 

or NRC rules. These program elements 

should not be adopted by the Agreement 

States. Adequacy Category H&S are 

program elements that are required 

because of a particular health and safety 

role in the regulation of agreement 

material within the State and should be 

adopted in a manner that embodies the 

essential objectives of the NRC program. 

The final rule is a matter of 

compatibility between the NRC and the 

Agreement States, thereby providing 

consistency among Agreement State and 

NRC requirements. Discussion on the 

Compatibility Category for § 35.3045, 

Report and notification of a medical 

event, can be found in Section V., 

Public Comment Analysis, of this 

document. The compatibility categories 

are designated in the following table: 

COMPATIBILITY TABLE

Section Change Subject 

Compatibility 

Existing New 

Part 30 

30.34(g) .............................. Amend ................................ Terms and conditions of licenses .......................................... B B 

Part 32 

32.72(a)(4) .......................... Amend ................................ Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under 10 CFR part 35.B B 

32.72(b)(5)(i) ....................... Amend ................................ Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under 10 CFR part 35.B B 

32.72(d) .............................. New .................................... Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under 10 CFR part 35................. B 

Part 35 

35.2 ..................................... New .................................... Definitions—Associate Radiation Safety Officer ................... ................ B 

35.2 ..................................... New .................................... Definitions—Ophthalmic physicist ......................................... ................ B 

35.2 ..................................... Amend ................................ Definitions—Preceptor ........................................................... D D 

35.12(b)(1) .......................... Amend ................................ Application for license, amendment, or renewal ................... D D 

35.12(c)(1) .......................... Amend ................................ Application for license, amendment, or renewal ................... D D 

35.12(c)(1)(ii) ...................... Amend ................................ Application for license, amendment, or renewal ................... D D 

35.12(d) .............................. Amend ................................ Application for license, amendment, or renewal ................... D D 

35.12(d)(1) .......................... New .................................... Application for license, amendment, or renewal ................... ................ D 

35.12(d)(2) .......................... New .................................... Application for license, amendment, or renewal ................... ................ D 

35.12(d)(3) .......................... New .................................... Application for license, amendment, or renewal ................... ................ D 

35.12(d)(4) .......................... Amend ................................ Application for license, amendment, or renewal ................... D D 

35.13(b) .............................. Amend ................................ License amendments ............................................................ D D 


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COMPATIBILITY TABLE—Continued 

Section Change Subject 

Compatibility 

Existing New 

35.13(d) .............................. New .................................... License amendments ............................................................ ................ D 

35.13(i) ................................ New .................................... License amendments ............................................................ ................ D 

35.14(a) .............................. Amend ................................ Notifications ........................................................................... D D 

35.14(b)(1) .......................... Amend ................................ Notifications ........................................................................... D D 

35.14(b)(2) .......................... Amend ................................ Notifications ........................................................................... D D 

35.14(b)(6) .......................... New .................................... Notifications ........................................................................... ................ D 

35.15(c) and (e) .................. Amend ................................ Exemptions regarding Type A specific licenses of broad 

scope.

D D 

35.24(b) .............................. Amend ................................ Authority and responsibilities for the radiation protection 

program.

H&S H&S 

35.24(c) ............................... Amend ................................ Authority and responsibilities for the radiation protection 

program.

D D 

35.40(b)(6) .......................... Amend ................................ Written directives ................................................................... H&S H&S 

35.40(b)(7) .......................... Amend Redesignated ......... Written directives ................................................................... H&S H&S 

35.41(b)(5) .......................... New .................................... Procedures for administrations requiring a written directive ................ H&S 

35.41(b)(6) .......................... New .................................... Procedures for administrations requiring a written directive ................ H&S 

35.50 ................................... Amend ................................ Training for Radiation Safety Officer and Associate Radiation Safety Officer.B B 

35.50(a) .............................. Amend ................................ Training for Radiation Safety Officer and Associate Radiation Safety Officer.B B 

35.50(a)(2)(ii)(B) ................. Amend ................................ Training for Radiation Safety Officer and Associate Radiation Safety Officer.B B 

35.50(b)(1)(ii) ...................... Amend ................................ Training for Radiation Safety Officer and Associate Radiation Safety Officer.B B 

35.50(b)(2) .......................... New .................................... Training for Radiation Safety Officer and Associate Radiation Safety Officer................. B 

35.50(c)(1) .......................... Amend ................................ Training for Radiation Safety Officer and Associate Radiation Safety Officer.B B 

35.50(c)(2) .......................... Amend ................................ Training for Radiation Safety Officer and Associate Radiation Safety Officer.B B 

35.50(c)(3) .......................... New .................................... Training for Radiation Safety Officer and Associate Radiation Safety Officer................. B 

35.50(d) .............................. Amend ................................ Training for Radiation Safety Officer and Associate Radiation Safety Officer.B B 

35.51(a) .............................. Amend ................................ Training for an authorized medical physicist ......................... B B 

35.51(a)(2)(i) ....................... Amend ................................ Training for an authorized medical physicist ......................... B B 

35.51(b)(2) .......................... Amend ................................ Training for an authorized medical physicist ......................... B B 

35.55(a) .............................. Amend ................................ Training for an authorized nuclear pharmacist ..................... B B 

35.55(b)(2) .......................... Amend ................................ Training for an authorized nuclear pharmacist ..................... B B 

35.57(a)(1) .......................... Amend ................................ Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

B B 

35.57(a)(2) .......................... New .................................... Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

................ B 

35.57(a)(3) .......................... New .................................... Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

................ B 

35.57(a)(4) .......................... Redesignated ..................... Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

D D 

35.57(b)(1) .......................... Amend ................................ Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

B B 

35.57(b)(2) .......................... Amend ................................ Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

B B 

35.57(b)(2)(i) ....................... New .................................... Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

................ B 


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COMPATIBILITY TABLE—Continued 

Section Change Subject 

Compatibility 

Existing New 

35.57(b)(2)(ii) ...................... New .................................... Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

................ B 

35.57(b)(2)(iii) ..................... New .................................... Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

................ B 

35.57(b)(2)(iv) ..................... New .................................... Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized 

nuclear pharmacist.

................ B 

35.65(a)(1)–(5) .................... Redesignated ..................... Authorization for calibration, transmission, and reference 

sources.

D D 

35.65(b) .............................. New .................................... Authorization for calibration, transmission, and reference 

sources.

................ D 

35.65(b)(1) .......................... New .................................... Authorization for calibration, transmission, and reference 

sources.

................ D 

35.65(b)(2) .......................... New .................................... Authorization for calibration, transmission, and reference 

sources.

................ D 

35.65(c) ............................... New .................................... Authorization for calibration, transmission, and reference 

sources.

................ D 

35.190(a) ............................ Amend ................................ Training for uptake, dilution, and excretion studies .............. B B 

35.190(c)(2) ........................ Amend ................................ Training for uptake, dilution, and excretion studies .............. B B 

35.190(c)(2)(i) ..................... New .................................... Training for uptake, dilution, and excretion studies .............. ................ B 

35.190(c)(2)(ii) .................... New .................................... Training for uptake, dilution, and excretion studies .............. ................ B 

35.204(b) ............................ Amend ................................ Permissible molybdenum-99, strontium-82, and strontium85 concentrations.H&S H&S 

35.204(e) ............................ New .................................... Permissible molybdenum-99, strontium-82, and strontium85 concentrations................. H&S 

35.290(a) ............................ Amend ................................ Training for imaging and localization studies ........................ B B 

35.290(c)(1)(ii) .................... Amend ................................ Training for imaging and localization studies ........................ B B 

35.290(c)(2) ........................ Amend ................................ Training for imaging and localization studies ........................ B B 

35.290(c)(2)(i) ..................... New .................................... Training for imaging and localization studies ........................ ................ B 

35.290(c)(2)(ii) .................... New .................................... Training for imaging and localization studies ........................ ................ B 

35.300 ................................. Amend ................................ Use of unsealed byproduct material for which a written directive is required.B B 

35.390(a) ............................ Amend ................................ Training for use of unsealed byproduct material for which a 

written directive is required.

B B 

35.390(b)(1)(ii) (G)(3) ......... Amend ................................ Training for use of unsealed byproduct material for which a 

written directive is required.

B B 

35.390(b)(2) ........................ Amend ................................ Training for use of unsealed byproduct material for which a 

written directive is required.

B B 

35.390(b)(2)(i) ..................... New .................................... Training for use of unsealed byproduct material for which a 

written directive is required.

................ B 

35.390(b)(2)(ii) .................... New .................................... Training for use of unsealed byproduct material for which a 

written directive is required.

................ B 

35.392(a) ............................ Amend ................................ Training 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).

B B 

35.392(c)(3) ........................ Amend ................................ Training 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).

B B 

35.392(c)(3)(i) ..................... New .................................... Training 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).

................ B 

35.392(c)(3)(ii) .................... New .................................... Training 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).

................ B 

35.394(a) ............................ Amend ................................ Training for the oral administration of sodium iodide I–131 

requiring a written directive in quantities greater than 

1.22 gigabecquerels (33 millicuries).

B B 

35.394(c)(3) ........................ Amend ................................ Training for the oral administration of sodium iodide I–131 

requiring a written directive in quantities greater than 

1.22 gigabecquerels (33 millicuries).

B B 

35.394(c)(3)(i) ..................... New .................................... Training for the oral administration of sodium iodide I–131 

requiring a written directive in quantities greater than 

1.22 gigabecquerels (33 millicuries).

................ B 


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COMPATIBILITY TABLE—Continued 

Section Change Subject 

Compatibility 

Existing New 

35.394(c)(3)(ii) .................... New .................................... Training for the oral administration of sodium iodide I–131 

requiring a written directive in quantities greater than 

1.22 gigabecquerels (33 millicuries).

................ B 

35.396(a)(1) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed byproduct material requiring a written directive.B B 

35.396(a)(2) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed byproduct material requiring a written directive.B B 

35.396(a)(3) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed byproduct material requiring a written directive.B B 

35.396(b)(1) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed byproduct material requiring a written directive.B B 

35.396(b)(2) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed byproduct material requiring a written directive.B B 

35.396(b)(2)(vi) ................... Amend Redesignated ......... Training for the parenteral administration of unsealed byproduct material requiring a written directive.B B 

35.396(b)(3) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed byproduct material requiring a written directive.B B 

35.396(b)(3)(i) ..................... New .................................... Training for the parenteral administration of unsealed byproduct material requiring a written directive................. B 

35.396(b)(3)(ii) .................... New .................................... Training for the parenteral administration of unsealed byproduct material requiring a written directive................. B 

35.400(a) ............................ Amend ................................ Use of sources for manual brachytherapy ............................ C C 

35.400(b) ............................ Amend ................................ Use of sources for manual brachytherapy ............................ C C 

35.433(a) ............................ Amend ................................ Strontium-90 sources for ophthalmic treatments .................. H&S B 

35.433(b) ............................ New .................................... Strontium-90 sources for ophthalmic treatments .................. ................ H&S 

35.433(b)(1) ........................ New .................................... Strontium-90 sources for ophthalmic treatments .................. ................ H&S 

35.433(b)(2) ........................ New .................................... Strontium-90 sources for ophthalmic treatments .................. ................ H&S 

35.433(c) ............................. Redesignated ..................... Strontium-90 sources for ophthalmic treatments (Previously 

35.433(b)).

D D 

35.490(a) ............................ Amend ................................ Training for use of manual brachytherapy sources .............. B B 

35.490(b)(1)(ii) .................... Amend ................................ Training for use of manual brachytherapy sources .............. B B 

35.490(b)(3) ........................ Amend ................................ Training for use of manual brachytherapy sources .............. B B 

35.490(b)(3)(i) ..................... New .................................... Training for use of manual brachytherapy sources .............. ................ B 

35.490(b)(3)(ii) .................... New .................................... Training for use of manual brachytherapy sources .............. ................ B 

35.491(b)(3) ........................ Amend ................................ Training for ophthalmic use of strontium-90 ......................... B B 

35.500(a) ............................ Amend ................................ Use of sealed sources and medical devices for diagnosis 

(Previously 35.500).

[C] C 

35.500(b) ............................ New .................................... Use of sealed sources and medical devices for diagnosis ... ................ C 

35.500(c) ............................. New .................................... Use of sealed sources and medical devices for diagnosis ... ................ C 

35.590 (a) ........................... Amend ................................ Training for use of sealed sources for diagnosis .................. B B 

35.590 (b) ........................... New .................................... Training for use of sealed sources for diagnosis .................. ................ B 

35.590 (c) ........................... Redesignated ..................... Training for use of sealed sources for diagnosis (Previously 

35.590(b)).

B B 

35.590 (d) ........................... Redesignated ..................... Training for use of sealed sources for diagnosis (Previously 

35.590(c)).

B B 

35.600(a) ............................ Amend ................................ Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.C C 

35.600(b) ............................ Amend ................................ Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.C C 

35.610(d)(1) ........................ New .................................... Safety procedures and instructions for remote afterloader 

units, teletherapy units, and gamma stereotactic 

radiosurgery units.

................ H&S 

35.610(d)(2) ........................ Amend ................................ Safety procedures and instructions for remote afterloader 

units, teletherapy units, and gamma stereotactic 

radiosurgery units.

H&S H&S 

35.610(g) ............................ Amend ................................ Safety procedures and instructions for remote afterloader 

units, teletherapy units, and gamma stereotactic 

radiosurgery units.

H&S H&S 

35.655(a) ............................ Amend ................................ Full-inspection servicing for teletherapy and gamma 

stereotactic radiosurgery units.

H&S H&S 

35.690(a) ............................ Amend ................................ Training for use of remote afterloader units, teletherapy 

units, and gamma stereotactic radiosurgery units.

B B 

35.690(b)(1)(ii) .................... Amend ................................ Training for use of remote afterloader units, teletherapy 

units, and gamma stereotactic radiosurgery units.

B B 

35.690(b)(3) ........................ Amend ................................ Training for use of remote afterloader units, teletherapy 

units, and gamma stereotactic radiosurgery units.

B B 

35.690(b)(3)(i) ..................... New .................................... Training for use of remote afterloader units, teletherapy 

units, and gamma stereotactic radiosurgery units.

................ B 

35.690(b)(3)(ii) .................... New .................................... Training for use of remote afterloader units, teletherapy 

units, and gamma stereotactic radiosurgery units.

................ B 


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COMPATIBILITY TABLE—Continued 

Section Change Subject 

Compatibility 

Existing New 

35.2024(c) ........................... New .................................... Records of authority and responsibilities for radiation protection programs................. D 

35.2024(c)(1) ...................... New .................................... Records of authority and responsibilities for radiation protection programs................. D 

35.2024(c)(2) ...................... New .................................... Records of authority and responsibilities for radiation protection programs................. D 

35.2310 ............................... Amend ................................ Records of safety instruction ................................................. D D 

35.2655(a) .......................... Amend ................................ Records of full-inspection servicing for teletherapy and 

gamma stereotactic radiosurgery units.

D D 

35.3045(a)(1) ...................... Amend ................................ Report and notification of a medical event ........................... C C 

35.3045(a)(2) ...................... New .................................... Report and notification of a medical event for permanent 

implant brachytherapy.

................ C 

35.3204(a) .......................... New .................................... Report and notification of an eluate exceeding permissible 

molybdenum-99, strontium-82, and strontium-85 concentrations.

................ C 

35.3204(b) .......................... New .................................... Written report of an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations................. C 

XIX. Coordination With the Advisory 

Committee on the Medical Uses of 

Isotopes 

The NRC staff consults with the 

ACMUI whenever it identifies an issue 

with implementation of 10 CFR part 35 

regulations. Accordingly, issues 

addressed by this rule have been 

discussed at ACMUI meetings over the 

last several years. The ACMUI meetings 

are transcribed. Full transcripts of the 

ACMUI meetings can be found online in 

the NRC Library at http://www.nrc.gov/ 

reading-rm/doc-collections/acmui/tr. In 

addition, in the SRM to SECY–10–0062, 

the Commission specifically directed 

the NRC staff to engage the ACMUI in 

developing the ME definition criterion 

for permanent implant brachytherapy. 

Further, the amendments that revise 

T&E requirements to eliminate 

preceptor attestation for board-certified 

individuals, change the language of the 

attestation, and allow a residency 

director to provide preceptor 

attestations were initiated by the 

ACMUI in its briefing to the 

Commission held on April 29, 2008 

(discussed in detail in Item b, Section 

III., Discussion, of this document). 

Similarly, the issue of naming more 

than one RSO was initiated by the 

ACMUI at the June 2007 ACMUI 

meeting (discussed in detail in Item d in 

Section III., Discussion, of this 

document). Finally, the entire ACMUI 

meeting held on April 20–21, 2011, was 

devoted to discussion of the rulemaking 

issues addressed in the proposed rule, 

so that the NRC staff would be better 

able to understand ACMUI’s position 

and views on the issues raised. 

In December 2012, the NRC provided 

the preliminary draft proposed rule to 

the ACMUI for a 90-day review. The 

draft proposed rule was made public to 

facilitate the ACMUI review in a public 

forum. The ACMUI discussed the draft 

proposed rule at two publicly held 

teleconferences on March 5 and March 

12, 2013. The ACMUI provided a final 

report, ‘‘Advisory Committee on the 

Medical Uses of Isotopes SubCommittee on Proposed Rule,’’ dated 

April 5, 2013, to the NRC on April 9, 

2013. 

While the ACMUI was supportive of 

most of the proposed amendments, it 

expressed concerns on some issues and 

provided its recommendations on those 

issues. Several comments resulted in 

revisions to the discussion section of the 

proposed rule to provide additional 

emphasis or clarity. However, the NRC 

did not accept all of the ACMUI 

recommendations. The 

recommendations that the NRC staff did 

not accept were discussed in a 

document entitled, ‘‘NRC Staff 

Responses to the ACMUI Comments on 

the Draft Part 35 Proposed Rule,’’ 

Enclosure 5, to SECY–13–0084. 

In addition, the ACMUI 

recommended that for permanent 

implant brachytherapy procedures, 

licensees be allowed to use total source 

strength as a substitute for total dose for 

determining MEs until the 10 CFR part 

35 rulemaking is completed. In 

response, on July 9, 2013, the 

Commission issued an interim 

enforcement policy (78 FR 41125) that 

addressed this issue. 

On October 6, 2015, the NRC 

provided the preliminary draft final rule 

to the ACMUI for a 90-day review. The 

ACMUI held a public teleconference on 

January 6, 2016, and provided a final 

report, ‘‘Advisory Committee on the 

Medical Uses of Isotopes SubCommittee on Draft Final Rule, 10 CFR 

parts 30, 32, and 35,’’ dated January 6, 

2016, to the NRC on January 6, 2016. 

The NRC prepared a response to the 

ACMUI recommendations and the 

response is listed in the list of available 

documents, in Section XXIII., 

‘‘Availability of Documents.’’ 

XX. Consistency With Medical Policy 

Statement 

The amendments to 10 CFR part 35 

are consistent with the Commission’s 

Medical Use Policy Statement published 

August 3, 2000 (65 FR 47654). This rule 

is consistent with the Commission’s 

statement because it balances the 

interests of the patient with the 

flexibility needed by the AU to take the 

actions that he or she deems medically 

necessary, while continuing to enable 

the NRC to detect deficiencies in 

processes, procedures, and training, as 

well as any misapplication of byproduct 

materials. 

XXI. Voluntary Consensus Standards 

The National Technology Transfer 

and Advancement Act of 1995 (Pub. L. 

104–113) requires that Federal agencies 

use technical standards that are 

developed or adopted by voluntary 

consensus standards bodies unless the 

use of such a standard is inconsistent 

with applicable law or otherwise 

impractical. In this final rule, the NRC 

is amending its medical use regulations 

related to ME definitions for permanent 

implant brachytherapy; T&E 

requirements for AUs, medical 

physicists, RSOs, and nuclear 

pharmacists; completing action on 

PRM–35–20 to ‘‘grandfather’’ certain 

experienced individuals; measuring Mo99 contamination for each elution and 


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33100 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Rules and Regulations 

reporting of failed breakthrough tests; 

naming ARSOs on a medical license; 

and making several minor clarifications. 

This action does not constitute the 

establishment of a standard that 

contains generally applicable 

requirements. 

XXII. Availability of Guidance 

Published elsewhere in this issue of 

the Federal Register, the NRC is issuing 

new guidance, ‘‘Guidance for the Final 

Rule ‘Medical Use of Byproduct 

Material—Medical Events, Definitions, 

Training and Experience, and Clarifying 

Amendments,’’ (NRC–2014–0030), for 

the implementation of the requirements 

in this final rule. 

XXIII. Availability of Documents 

The documents identified in the 

following table are available to 

interested persons through one or more 

of the following methods, as indicated. 

Date Document ADAMS 

accession No. 

03/01/2004 ........ 03/01/2004 Transcript of Advisory Committee on the Medical Uses of Isotopes Meeting in Rockville MD, 

Pages 1–194.

ML040780651 

06/28/2005 ........ Transcript of the Advisory Committee on the Medical Uses of Isotopes Medical Event Subcommittee Meeting.ML052360415 

12/27/2005 ........ SECY–05–0234, ‘‘Adequacy of Medical Event Definitions in 10 CFR 35.3045, and Communicating Associated Risks to the Public’’.ML053180408 

02/15/2006 ........ SRM–SECY–05–0234, ‘‘Adequacy of Medical Event Definitions in 10 CFR 35.3045, and Communicating 

Associated Risks to the Public’’.

ML060460594 

09/10/2006 ........ PRM–35–20, ‘‘AAPM Petition for Rulemaking to Amend 10 CFR 35.57, Training for Experience Radiation 

Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Authorized User, Nuclear 

Pharmacist, and Authorized Nuclear Pharmacist,’’ filed by E. Russell Ritenour.

ML062620129 

06/12/2007 ........ Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, June 12, 2007, 

Pages 1–325.

ML072340094 

04/29/2008 ........ M080429—Commission Meeting with the Advisory Committee on the Medical Uses of Isotopes, Transcript ML081270628 

05/15/2008 ........ SRM–M080429, Meeting with Advisory Committee on the Medical Uses of Isotopes (ACMUI) 1:30 p.m., 

Tuesday, April 29, 2008.

ML081360319 

11/20/2008 ........ SECY–08–0179, ‘‘Recommendations on Amending Preceptor Attestation Requirements in 10 CFR part 

35, Medical Use of Byproduct Material’’.

ML083170176 

01/16/2009 ........ SRM–SECY–08–0179, ‘‘Recommendations on Amending Preceptor Attestation Requirements in 10 CFR 

part 35, Medical Use of Byproduct Material’’.

ML090160275 

05/18/2010 ........ SECY–10–0062, ‘‘Reproposed Rule: Medical Use of Byproduct Material—Amendments/Medical Event 

Definitions’’.

ML100890121 

07/08/2010 ........ M100708B—Commission Briefing on ‘‘Proposed Rule on Part 35 Medical Events Definitions—Permanent 

Implant Brachytherapy,’’ Transcript.

ML101930532 

08/10/2010 ........ SRM–SECY–10–0062, ‘‘Reproposed Rule: Medical Use of Byproduct Material—Amendments/Medical 

Event Definitions (RIN 3150–AI26)’’.

ML102220233 

10/20/2010 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, Open Session, 

October 20, 2010, Pages 1–168.

ML103350657 

10/20/2010 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Permanent Implant Brachytherapy Interim 

Report.

ML103540385 

04/11/2011 ........ Final Transcript of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, April 11, 

2011, Pages 1–226.

ML11174A070 

05/16/2011 ........ Part 35 Preliminary Draft Proposed Rule Language, provided for ACMUI review .......................................... ML111390420 

05/20/2011 ........ FSME–11–044, ‘‘Opportunity to Comment on Preliminary Proposed Rule Language for Medical Use Regulations’’.ML111400231 

06/20/2011 ........ Public Meeting Summary for Part 35 Medical Workshop, June 20–21, 2011 ................................................. ML111930470 

08/11/2011 ........ Transcript of Public Workshop for Discussion of Topics Related to NRC’s Medical Regulations, August 11, 

2011, Pages 1–240.

ML112900103 

08/12/2011 ........ Transcript of Public Workshop for Discussion of Topics Related to NRC’s Medical Regulations, August 12, 

2011, Pages 1–192.

ML112900185 

10/18/2011 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Permanent Implant Brachytherapy Final 

Report.

ML11292A139 

10/18/2011 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference Meeting, October 18, 2011, Pages 1–77.ML12062A275 

11/30/2011 ........ The American Society for Radiation Oncology (ASTRO) letter to the Chairman of the ACMUI ..................... ML11341A051 

02/07/2012 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Permanent Implant Brachytherapy Revised 

Final Report.

ML12038A279 

02/07/2012 ........ Final Transcript of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference 

Meeting, February 7, 2012, Pages 1–85.

ML12242A101 

02/13/2012 ........ ASTRO letter to the Chairman of the ACMUI .................................................................................................. ML12044A358 

04/05/2012 ........ SECY–12–0053, ‘‘Recommendations on Regulatory Changes for Permanent Implant Brachytherapy Programs’’.ML12072A306 

04/24/2012 ........ Transcript of Commission Meeting April 24, 2012, before Commission vote on SECY–12–0053, ‘‘Recommendations on Regulatory Changes for Permanent Implant Brachytherapy Programs’’.ML12116A294 

08/13/2012 ........ SRM–SECY–12–0053, ‘‘Recommendations on Regulatory Changes for Permanent Implant Brachytherapy 

Programs’’.

ML122260211 

01/14/2013 ........ Part 35 Preliminary Draft Proposed Rule Federal Register Notice, provided for ACMUI review .................. ML13014A487 

03/05/2013 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference Meeting, March 5, 2013, Pages 1–111.ML13175A030 

03/12/2013 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference Meeting, March 12, 2013, Pages 1–115.ML13175A028 

03/28/2013 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Comments on the Proposed Rule, 10 CFR 

parts 30, 32 and 35, Final Report.

ML13071A690 


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Date Document ADAMS 

accession No. 

08/08/2013 ........ SECY–13–0084, ‘‘Proposed Rule: Medical Use of Byproduct Material—Medical Event Definitions, Training 

and Experience, and Clarifying Amendments (RIN 3150–AI63)’’.

ML13179A068 

08/08/2013 ........ SECY–13–0085, Enclosure 5, ‘‘NRC Staff Responses to the ACMUI Comments on the Draft Part 35 Proposed Rule’’.ML13179A073 

01/06/2014 ........ SRM–SECY–13–0084, ‘‘Proposed Rule: Medical Use of Byproduct Material—Medical Event Definitions, 

Training and Experience, and Clarifying Amendments (RIN 3150–AI63)’’.

ML14007A044 

07/23/2014 ........ Draft Environmental Assessment: Proposed Rule Amending 10 CFR parts 30, 32, and 35—Medical Use of 

Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments.

ML14184A621 

07/23/2014 ........ Draft Regulatory Analysis: Proposed Rule: Amendments to Medical Use of Byproduct Material Regulations, 10 CFR parts 30, 32, and 35.ML14184A620 

08/15/2014 ........ FSME–14–078, ‘‘Opportunity to Comment on Proposed Amendments to Medical Use of Byproduct Material Regulations, 10 CFR 30, 32, and 35 and Notification of October 8, 2014 Public Meeting’’.ML14226A319 

10/08/2014 ........ Part 35 Proposed Rule Public Meeting Transcript, Pages 1–171, October 8, 2014 ....................................... ML15026A317 

02/12/2015 ........ Meeting Summary: Public Meeting Between Spectrum Pharmaceuticals, Inc., and the Nuclear Regulatory 

Commission (NRC) Regarding Modification of the Training and Experiences Requirements for Beta 

Emitter Products.

ML15054A215 

06/16/2015 ........ Final Transcript of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference 

Meeting, June 16, 2015, Pages 1–109.

ML15285A016 

09/21/2015 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Training and Experience for Authorized 

Users of Alpha and Beta Emitters Draft Subcommittee Report.

ML15271A124 

10/08/2015 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, October 8, 

2015, Open Session, Pages 1–255.

ML15357A551 

10/09/2015 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, October 9, 

2015, Open Session, Pages 1–262.

ML15357A552 

01/06/2016 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Comments on the Draft Final Rule, 10 

CFR parts 30, 32 and 35, Final Report.

ML16007A771 

03/16/2016 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Training and Experience for Authorized 

Users of Alpha and Beta Emitters under 10 CFR 35.390, Final Report.

ML16089A271 

June 2016 ......... Final Environmental Assessment ...................................................................................................................... ML16124B050 

June 2016 ......... Final Regulatory Analysis ................................................................................................................................. ML16124B034 

June 2016 ......... NRC Staff Response to the Advisory Committee on the Medical Uses of Isotopes’ Part 35 Draft Final 

Rule—Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and 

Clarifying Amendments; Final Comments.’’.

ML16124B068 

June 2016 ......... Summary of Specific Agreement State and Organization of Agreement States Comments on the Draft 

Final Rule and Staff Response.

ML16124B069 

December 2016 Final Implementing Guidance ........................................................................................................................... ML16126A441 

List of Subjects 

10 CFR Part 30 

Byproduct material, Criminal 

penalties, Government contracts, 

Intergovernmental relations, Isotopes, 

Nuclear energy, Nuclear materials, 

Penalties, Radiation protection, 

Reporting and recordkeeping 

requirements, Whistleblowing. 

10 CFR Part 32 

Byproduct material, Criminal 

penalties, Labeling, Nuclear energy, 

Nuclear materials, Radiation protection, 

Reporting and recordkeeping 

requirements. 

10 CFR Part 35 

Biologics, Byproduct material, 

Criminal penalties, Drugs, Health 

facilities, Health professions, Labeling, 

Medical devices, Nuclear energy, 

Nuclear materials, Occupational safety 

and health, Penalties, Radiation 

protection, Reporting and recordkeeping 

requirements. 

For the reasons set out in the 

preamble and under the authority of the 

Atomic Energy Act of 1954, as amended; 

the Energy Reorganization Act of 1974, 

as amended; and 5 U.S.C. 552 and 553, 

the NRC is adopting the following 

amendments to 10 CFR parts 30, 32, and 

35: 

PART 30—RULES OF GENERAL 

APPLICABILITY TO DOMESTIC 

LICENSING OF BYPRODUCT 

MATERIAL 

■ 1. The authority citation for part 30 

continues to read as follows: 

Authority: Atomic Energy Act of 1954, 

secs. 11, 81, 161, 181, 182, 183, 184, 186, 

187, 223, 234, 274 (42 U.S.C. 2014, 2111, 

2201, 2231, 2232, 2233, 2234, 2236, 2237, 

2273, 2282, 2021); Energy Reorganization Act 

of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 

5841, 5842, 5846, 5851); 44 U.S.C. 3504 note. 

■ 2. In § 30.34, add a third sentence to 

paragraph (g) to read as follows: 

§ 30.34 Terms and conditions of licenses. 

* * * * * 

(g) * * * The licensee shall report the 

results of any test that exceeds the 

permissible concentration listed in 

§ 35.204(a) of this chapter at the time of 

generator elution, in accordance with 

§ 35.3204 of this chapter. 

* * * * * 

PART 32—SPECIFIC DOMESTIC 

LICENSES TO MANUFACTURE OR 

TRANSFER CERTAIN ITEMS 

CONTAINING BYPRODUCT MATERIAL 

■ 3. The authority citation for part 32 

continues to read as follows: 

Authority: Atomic Energy Act of 1954, 

secs. 81, 161, 181, 182, 183, 223, 234, 274 (42 

U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 

2282, 2021); Energy Reorganization Act of 

1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 

3504 note. 

■ 4. In § 32.72: 

■ a. Revise paragraphs (a)(4) 

introductory text and (b)(5)(i); 

■ b. Redesignate paragraph (d) as 

paragraph (e); and 

■ c. Add new paragraph (d). 

The revisions and addition read as 

follows: 

§ 32.72 Manufacture, preparation, or 

transfer for commercial distribution of 

radioactive drugs containing byproduct 

material for medical use under part 35. 

(a) * * * 

(4) The applicant commits to the 

following labeling requirements: 

* * * * * 

(b) * * * 


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(5) * * * 

(i) A copy of each individual’s 

certification by a specialty board whose 

certification process has been 

recognized by the Commission or an 

Agreement State as specified in 

§ 35.55(a) of this chapter; or 

* * * * * 

(d) A licensee shall satisfy the 

labeling requirements in paragraph 

(a)(4) of this section. 

* * * * * 

PART 35—MEDICAL USE OF 

BYPRODUCT MATERIAL 

■ 5. The authority citation for part 35 

continues to read as follows: 

Authority: Atomic Energy Act of 1954, 

secs. 81, 161, 181, 182, 183, 223, 234, 274 (42 

U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 

2282, 2021); Energy Reorganization Act of 

1974, secs. 201, 206 (42 U.S.C. 5841, 5846); 

44 U.S.C. 3504 note. 

■ 6. In § 35.2, add in alphabetical order 

definitions for Associate Radiation 

Safety Officer and Ophthalmic physicist 

and revise the definition of Preceptor to 

read as follows: 

§ 35.2 Definitions. 

* * * * * 

Associate Radiation Safety Officer 

means an individual who— 

(1) Meets the requirements in §§ 35.50 

and 35.59; and 

(2) Is currently identified as an 

Associate Radiation Safety Officer for 

the types of use of byproduct material 

for which the individual has been 

assigned duties and tasks by the 

Radiation Safety Officer on— 

(i) A specific medical use license 

issued by the Commission or an 

Agreement State; or 

(ii) A medical use permit issued by a 

Commission master material licensee. 

* * * * * 

Ophthalmic physicist means an 

individual who— 

(1) Meets the requirements in 

§§ 35.433(a)(2) and 35.59; and 

(2) Is identified as an ophthalmic 

physicist on a— 

(i) Specific medical use license issued 

by the Commission or an Agreement 

State; 

(ii) Permit issued by a Commission or 

Agreement State broad scope medical 

use licensee; 

(iii) Medical use permit issued by a 

Commission master material licensee; or 

(iv) Permit issued by a Commission 

master material licensee broad scope 

medical use permittee. 

* * * * * 

Preceptor means an individual who 

provides, directs, or verifies training 

and experience required for an 

individual to become an authorized 

user, an authorized medical physicist, 

an authorized nuclear pharmacist, a 

Radiation Safety Officer, or an Associate 

Radiation Safety Officer. 

* * * * * 

■ 7. In § 35.8, revise paragraph (b) to 

read as follows: 

§ 35.8 Information collection 

requirements: OMB approval. 

* * * * * 

(b) The approved information 

collection requirements contained in 

this part appear in §§ 35.6, 35.12, 35.13, 

35.14, 35.19, 35.24, 35.26, 35.27, 35.40, 

35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 

35.63, 35.67, 35.69, 35.70, 35.75, 35.80, 

35.92, 35.190, 35.204, 35.290, 35.310, 

35.315, 35.390, 35.392, 35.394, 35.396, 

35.404, 35.406, 35.410, 35.415, 35.432, 

35.433, 35.490, 35.491, 35.590, 35.604, 

35.605, 35.610, 35.615, 35.630, 35.632, 

35.633, 35.635, 35.642, 35.643, 35.645, 

35.647, 35.652, 35.655, 35.690, 35.1000, 

35.2024, 35.2026, 35.2040, 35.2041, 

35.2060, 35.2061, 35.2063, 35.2067, 

35.2070, 35.2075, 35.2080, 35.2092, 

35.2204, 35.2310, 35.2404, 35.2406, 

35.2432, 35.2433, 35.2605, 35.2610, 

35.2630, 35.2632, 35.2642, 35.2643, 

35.2645, 35.2647, 35.2652, 35.2655, 

35.3045, 35.3047, 35.3067, and 35.3204. 

* * * * * 

■ 8. In § 35.12, revise paragraphs (b)(1), 

(c)(1) introductory text, (c)(1)(ii), and (d) 

to read as follows: 

§ 35.12 Application for license, 

amendment, or renewal. 

* * * * * 

(b) * * * 

(1) Filing an original NRC Form 313, 

‘‘Application for Material License,’’ that 

includes the facility diagram, 

equipment, and training and experience 

qualifications of the Radiation Safety 

Officer, Associate Radiation Safety 

Officer(s), authorized user(s), authorized 

medical physicist(s), ophthalmic 

physicist(s), and authorized nuclear 

pharmacist(s); and 

* * * * * 

(c) * * * 

(1) Submitting an original of either— 

* * * * * 

(ii) A letter containing all information 

required by NRC Form 313; and 

* * * * * 

(d) In addition to the requirements in 

paragraphs (b) and (c) of this section, an 

application for a license or amendment 

for medical use of byproduct material as 

described in § 35.1000 must also 

include: 

(1) Any additional aspects of the 

medical use of the material that are 

applicable to radiation safety that are 

not addressed in, or differ from, 

subparts A through C, L, and M of this 

part; 

(2) Identification of and commitment 

to follow the applicable radiation safety 

program requirements in subparts D 

through H of this part that are 

appropriate for the specific § 35.1000 

medical use; 

(3) Any additional specific 

information on— 

(i) Radiation safety precautions and 

instructions; 

(ii) Methodology for measurement of 

dosages or doses to be administered to 

patients or human research subjects; 

and 

(iii) Calibration, maintenance, and 

repair of instruments and equipment 

necessary for radiation safety; and 

(4) Any other information requested 

by the Commission in its review of the 

application. 

* * * * * 

■ 9. In § 35.13: 

■ a. Revise paragraph (b); 

■ b. Redesignate paragraphs (d) through 

(g) as paragraphs (e) through (h); 

■ c. Add new paragraph (d); 

■ c. Revise newly redesignated 

paragraphs (g) and (h); and 

■ d. Add paragraph (i). 

The revisions and additions read as 

follows: 

§ 35.13 License amendments. 

* * * * * 

(b) Before it permits anyone to work 

as an authorized user, authorized 

medical physicist, ophthalmic physicist, 

or authorized nuclear pharmacist under 

the license, except— 

(1) For an authorized user, an 

individual who meets the requirements 

in §§ 35.59 and 35.190(a), 35.290(a), 

35.390(a), 35.392(a), 35.394(a), 

35.490(a), 35.590(a), and 35.690(a); 

(2) For an authorized nuclear 

pharmacist, an individual who meets 

the requirements in §§ 35.55(a) and 

35.59; 

(3) For an authorized medical 

physicist, an individual who meets the 

requirements in §§ 35.51(a) and 35.59; 

(4) An individual who is identified as 

an authorized user, an authorized 

nuclear pharmacist, authorized medical 

physicist, or an ophthalmic physicist— 

* * * * * 

(d) Before it permits anyone to work 

as an Associate Radiation Safety Officer, 

or before the Radiation Safety Officer 

assigns duties and tasks to an Associate 

Radiation Safety Officer that differ from 

those for which this individual is 

authorized on the license; 

* * * * * 


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(g) Before it changes the address(es) of 

use identified in the application or on 

the license; 

(h) Before it revises procedures 

required by §§ 35.610, 35.642, 35.643, 

and 35.645, as applicable, where such 

revision reduces radiation safety; and 

(i) Before it receives a sealed source 

from a different manufacturer or of a 

different model number than authorized 

by its license unless the sealed source 

is used for manual brachytherapy, is 

listed in the Sealed Source and Device 

Registry, and is in a quantity and for an 

isotope authorized by the license. 

■ 10. In § 35.14, revise paragraphs (a) 

and (b) to read as follows: 

§ 35.14 Notifications. 

(a) A licensee shall provide the 

Commission, no later than 30 days after 

the date that the licensee permits an 

individual to work under the provisions 

of § 35.13(b) as an authorized user, 

authorized medical physicist, 

ophthalmic physicist, or authorized 

nuclear pharmacist— 

(1) A copy of the board certification 

and, as appropriate, verification of 

completion of: 

(i) Training for the authorized medical 

physicist under § 35.51(c); 

(ii) Any additional case experience 

required in § 35.390(b)(1)(ii)(G) for an 

authorized user under § 35.300; or 

(iii) Device specific training in 

§ 35.690(c) for the authorized user under 

§ 35.600; or 

(2) A copy of the Commission or 

Agreement State license, the permit 

issued by a Commission master material 

licensee, the permit issued by a 

Commission or Agreement State 

licensee of broad scope, the permit 

issued by a Commission master material 

license broad scope permittee, or 

documentation that only acceleratorproduced radioactive materials, discrete 

sources of radium-226, or both, were 

used for medical use or in the practice 

of nuclear pharmacy at a Government 

agency or Federally recognized Indian 

Tribe before November 30, 2007, or at 

all other locations of use before August 

8, 2009, or an earlier date as noticed by 

the NRC for each individual whom the 

licensee permits to work under the 

provisions of this section. 

(b) A licensee shall notify the 

Commission no later than 30 days after: 

(1) An authorized user, an authorized 

nuclear pharmacist, a Radiation Safety 

Officer, an Associate Radiation Safety 

Officer, an authorized medical 

physicist, or ophthalmic physicist 

permanently discontinues performance 

of duties under the license or has a 

name change; 

(2) The licensee permits an individual 

qualified to be a Radiation Safety Officer 

under §§ 35.50 and 35.59 to function as 

a temporary Radiation Safety Officer 

and to perform the functions of a 

Radiation Safety Officer in accordance 

with § 35.24(c); 

(3) The licensee’s mailing address 

changes; 

(4) The licensee’s name changes, but 

the name change does not constitute a 

transfer of control of the license as 

described in § 30.34(b) of this chapter; 

(5) The licensee has added to or 

changed the areas of use identified in 

the application or on the license where 

byproduct material is used in 

accordance with either § 35.100 or 

§ 35.200 if the change does not include 

addition or relocation of either an area 

where PET radionuclides are produced 

or a PET radioactive drug delivery line 

from the PET radionuclide/PET 

radioactive drug production area; or 

(6) The licensee obtains a sealed 

source for use in manual brachytherapy 

from a different manufacturer or with a 

different model number than authorized 

by its license for which it did not 

require a license amendment as 

provided in § 35.13(i). The notification 

must include the manufacturer and 

model number of the sealed source, the 

isotope, and the quantity per sealed 

source. 

* * * * * 

■ 11. In § 35.15, revise paragraphs (c) 

and (e) to read as follows: 

§ 35.15 Exemptions regarding Type A 

specific licenses of broad scope. 

* * * * * 

(c) The provisions of § 35.13(f) 

regarding additions to or changes in the 

areas of use at the addresses identified 

in the application or on the license; 

* * * * * 

(e) The provisions of § 35.14(b)(1) for 

an authorized user, an authorized 

nuclear pharmacist, an authorized 

medical physicist, or an ophthalmic 

physicist; 

* * * * * 

■ 12. In § 35.24, revise paragraphs (b) 

and (c) to read as follows: 

§ 35.24 Authority and responsibilities for 

the radiation protection program. 

* * * * * 

(b) A licensee’s management shall 

appoint a Radiation Safety Officer who 

agrees, in writing, to be responsible for 

implementing the radiation protection 

program. The licensee, through the 

Radiation Safety Officer, shall ensure 

that radiation safety activities are being 

performed in accordance with licenseeapproved procedures and regulatory 

requirements. A licensee’s management 

may appoint, in writing, one or more 

Associate Radiation Safety Officers to 

support the Radiation Safety Officer. 

The Radiation Safety Officer, with 

written agreement of the licensee’s 

management, must assign the specific 

duties and tasks to each Associate 

Radiation Safety Officer. These duties 

and tasks are restricted to the types of 

use for which the Associate Radiation 

Safety Officer is listed on a license. The 

Radiation Safety Officer may delegate 

duties and tasks to the Associate 

Radiation Safety Officer but shall not 

delegate the authority or responsibilities 

for implementing the radiation 

protection program. 

(c) For up to 60 days each year, a 

licensee may permit an individual 

qualified to be a Radiation Safety 

Officer, under §§ 35.50 and 35.59, to 

function as a temporary Radiation 

Safety Officer and to perform the 

functions of a Radiation Safety Officer, 

as provided in paragraph (g) of this 

section, if the licensee takes the actions 

required in paragraphs (b), (e), (g), and 

(h) of this section and notifies the 

Commission in accordance with 

§ 35.14(b). 

* * * * * 

■ 13. In § 35.40: 

■ a. Revise paragraph (b)(5); 

■ b. Redesignate paragraph (b)(6) as 

paragraph (b)(7); 

■ c. Add new paragraph (b)(6); 

■ d. Revise newly redesignated 

paragraph (b)(7); 

■ e. Redesignate paragraph (c) 

introductory text as paragraph (c)(1); 

and 

■ f. Redesignate paragraph (c)(1) as 

paragraph (c)(2). 

The revisions and addition read as 

follows: 

§ 35.40 Written directives. 

* * * * * 

(b) * * * 

(5) For high dose-rate remote 

afterloading brachytherapy: The 

radionuclide, treatment site, dose per 

fraction, number of fractions, and total 

dose; 

(6) For permanent implant 

brachytherapy: 

(i) Before implantation: The treatment 

site, the radionuclide, and the total 

source strength; and 

(ii) After implantation but before the 

patient leaves the post-treatment 

recovery area: The treatment site, the 

number of sources implanted, the total 

source strength implanted, and the date; 

or 

(7) For all other brachytherapy, 

including low, medium, and pulsed 

dose rate remote afterloaders: 


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33104 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Rules and Regulations 

(i) Before implantation: The treatment 

site, radionuclide, and dose; and 

(ii) After implantation but before 

completion of the procedure: The 

radionuclide; treatment site; number of 

sources; total source strength and 

exposure time (or the total dose); and 

date. 

* * * * * 

■ 14. In § 35.41, revise paragraphs (b)(3) 

and (4) and add paragraphs (b)(5) and 

(6) to read as follows: 

§ 35.41 Procedures for administrations 

requiring a written directive. 

* * * * * 

(b) * * * 

(3) Checking both manual and 

computer-generated dose calculations; 

(4) Verifying that any computergenerated dose calculations are correctly 

transferred into the consoles of 

therapeutic medical units authorized by 

§§ 35.600 or 35.1000; 

(5) Determining if a medical event, as 

defined in § 35.3045, has occurred; and 

(6) Determining, for permanent 

implant brachytherapy, within 60 

calendar days from the date the implant 

was performed, the total source strength 

administered outside of the treatment 

site compared to the total source 

strength documented in the postimplantation portion of the written 

directive, unless a written justification 

of patient unavailability is documented. 

* * * * * 

■ 15. Revise § 35.50 to read as follows: 

§ 35.50 Training for Radiation Safety 

Officer and Associate Radiation Safety 

Officer. 

Except as provided in § 35.57, the 

licensee shall require an individual 

fulfilling the responsibilities of the 

Radiation Safety Officer or an 

individual assigned duties and tasks as 

an Associate Radiation Safety Officer as 

provided in § 35.24 to be an individual 

who— 

(a) Is certified by a specialty board 

whose certification process has been 

recognized by the Commission or an 

Agreement State and who meets the 

requirements in paragraph (d) of this 

section. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page. To 

have its certification process recognized, 

a specialty board shall require all 

candidates for certification to: (1)(i) 

Hold a bachelor’s or graduate degree 

from an accredited college or university 

in physical science or engineering or 

biological science with a minimum of 

20 college credits in physical science; 

(ii) Have 5 or more years of 

professional experience in health 

physics (graduate training may be 

substituted for no more than 2 years of 

the required experience) including at 

least 3 years in applied health physics; 

and 

(iii) Pass an examination administered 

by diplomates of the specialty board, 

which evaluates knowledge and 

competence in radiation physics and 

instrumentation, radiation protection, 

mathematics pertaining to the use and 

measurement of radioactivity, radiation 

biology, and radiation dosimetry; or 

(2)(i) Hold a master’s or doctor’s 

degree in physics, medical physics, 

other physical science, engineering, or 

applied mathematics from an accredited 

college or university; 

(ii) Have 2 years of full-time practical 

training and/or supervised experience 

in medical physics— 

(A) Under the supervision of a 

medical physicist who is certified in 

medical physics by a specialty board 

recognized by the Commission or an 

Agreement State; or 

(B) In clinical nuclear medicine 

facilities providing diagnostic or 

therapeutic services under the direction 

of physicians who meet the 

requirements for authorized users in 

§§ 35.57, 35.290, or 35.390; and 

(iii) Pass an examination, 

administered by diplomates of the 

specialty board, that assesses knowledge 

and competence in clinical diagnostic 

radiological or nuclear medicine 

physics and in radiation safety; or 

(b)(1) Has completed a structured 

educational program consisting of both: 

(i) 200 hours of classroom and 

laboratory training in the following 

areas— 

(A) Radiation physics and 

instrumentation; 

(B) Radiation protection; 

(C) Mathematics pertaining to the use 

and measurement of radioactivity; 

(D) Radiation biology; and 

(E) Radiation dosimetry; and 

(ii) One year of full-time radiation 

safety experience under the supervision 

of the individual identified as the 

Radiation Safety Officer on a 

Commission or an Agreement State 

license or permit issued by a 

Commission master material licensee 

that authorizes similar type(s) of use(s) 

of byproduct material. An Associate 

Radiation Safety Officer may provide 

supervision for those areas for which 

the Associate Radiation Safety Officer is 

authorized on a Commission or an 

Agreement State license or permit 

issued by a Commission master material 

licensee. The full-time radiation safety 

experience must involve the following— 

(A) Shipping, receiving, and 

performing related radiation surveys; 

(B) Using and performing checks for 

proper operation of instruments used to 

determine the activity of dosages, 

survey meters, and instruments used to 

measure radionuclides; 

(C) Securing and controlling 

byproduct material; 

(D) Using administrative controls to 

avoid mistakes in the administration of 

byproduct material; 

(E) Using procedures to prevent or 

minimize radioactive contamination 

and using proper decontamination 

procedures; 

(F) Using emergency procedures to 

control byproduct material; and 

(G) Disposing of byproduct material; 

and 

(2) This individual must obtain a 

written attestation, signed by a 

preceptor Radiation Safety Officer or 

Associate Radiation Safety Officer who 

has experience with the radiation safety 

aspects of similar types of use of 

byproduct material for which the 

individual is seeking approval as a 

Radiation Safety Officer or an Associate 

Radiation Safety Officer. The written 

attestation must state that the individual 

has satisfactorily completed the 

requirements in paragraphs (b)(1) and 

(d) of this section, and is able to 

independently fulfill the radiation 

safety-related duties as a Radiation 

Safety Officer or as an Associate 

Radiation Safety Officer for a medical 

use license; or 

(c)(1) Is a medical physicist who has 

been certified by a specialty board 

whose certification process has been 

recognized by the Commission or an 

Agreement State under § 35.51(a), has 

experience with the radiation safety 

aspects of similar types of use of 

byproduct material for which the 

licensee seeks the approval of the 

individual as Radiation Safety Officer or 

an Associate Radiation Safety Officer, 

and meets the requirements in 

paragraph (d) of this section; or 

(2) Is an authorized user, authorized 

medical physicist, or authorized nuclear 

pharmacist identified on a Commission 

or an Agreement State license, a permit 

issued by a Commission master material 

licensee, a permit issued by a 

Commission or an Agreement State 

licensee of broad scope, or a permit 

issued by a Commission master material 

license broad scope permittee, has 

experience with the radiation safety 

aspects of similar types of use of 

byproduct material for which the 

licensee seeks the approval of the 

individual as the Radiation Safety 

Officer or Associate Radiation Safety 


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Officer, and meets the requirements in 

paragraph (d) of this section; or 

(3) Has experience with the radiation 

safety aspects of the types of use of 

byproduct material for which the 

individual is seeking simultaneous 

approval both as the Radiation Safety 

Officer and the authorized user on the 

same new medical use license or new 

medical use permit issued by a 

Commission master material license. 

The individual must also meet the 

requirements in paragraph (d) of this 

section. 

(d) Has training in the radiation 

safety, regulatory issues, and emergency 

procedures for the types of use for 

which a licensee seeks approval. This 

training requirement may be satisfied by 

completing training that is supervised 

by a Radiation Safety Officer, an 

Associate Radiation Safety Officer, 

authorized medical physicist, 

authorized nuclear pharmacist, or 

authorized user, as appropriate, who is 

authorized for the type(s) of use for 

which the licensee is seeking approval. 

■ 16. In § 35.51, revise paragraphs (a) 

introductory text, (a)(2)(i), and (b)(2) to 

read as follows: 

§ 35.51 Training for an authorized medical 

physicist. 

* * * * * 

(a) Is certified by a specialty board 

whose certification process has been 

recognized by the Commission or an 

Agreement State and who meets the 

requirements in paragraph (c) of this 

section. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page. To 

have its certification process recognized, 

a specialty board shall require all 

candidates for certification to: 

* * * * * 

(2) * * * 

(i) Under the supervision of a medical 

physicist who is certified in medical 

physics by a specialty board whose 

certification process has been 

recognized under this section by the 

Commission or an Agreement State; or 

* * * * * 

(b) * * * 

(2) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraphs (b)(1) and (c) of this section, 

and is able to independently fulfill the 

radiation safety-related duties as an 

authorized medical physicist for each 

type of therapeutic medical unit for 

which the individual is requesting 

authorized medical physicist status. The 

written attestation must be signed by a 

preceptor authorized medical physicist 

who meets the requirements in § 35.51, 

§ 35.57, or equivalent Agreement State 

requirements for an authorized medical 

physicist for each type of therapeutic 

medical unit for which the individual is 

requesting authorized medical physicist 

status. 

* * * * * 

■ 17. In § 35.55, revise paragraphs (a) 

introductory text and (b)(2) to read as 

follows: 

§ 35.55 Training for an authorized nuclear 

pharmacist. 

* * * * * 

(a) Is certified by a specialty board 

whose certification process has been 

recognized by the Commission or an 

Agreement State. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page. To 

have its certification process recognized, 

a specialty board shall require all 

candidates for certification to: 

* * * * * 

(b) * * * 

(2) Has obtained written attestation, 

signed by a preceptor authorized 

nuclear pharmacist, that the individual 

has satisfactorily completed the 

requirements in paragraph (b)(1) of this 

section and is able to independently 

fulfill the radiation safety-related duties 

as an authorized nuclear pharmacist. 

■ 18. In § 35.57, revise paragraphs (a) 

and (b) to read as follows: 

§ 35.57 Training for experienced Radiation 

Safety Officer, teletherapy or medical 

physicist, authorized medical physicist, 

authorized user, nuclear pharmacist, and 

authorized nuclear pharmacist. 

(a)(1) An individual 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 

license permittee of broad scope as a 

Radiation Safety Officer, a teletherapy 

or medical physicist, an authorized 

medical physicist, a nuclear pharmacist 

or an authorized nuclear pharmacist on 

or before January 14, 2019 need not 

comply with the training requirements 

of § 35.50, § 35.51, or § 35.55, 

respectively, except the Radiation Safety 

Officers and authorized medical 

physicists identified in this paragraph 

must meet the training requirements in 

§ 35.50(d) or § 35.51(c), as appropriate, 

for any material or uses for which they 

were not authorized prior to this date. 

(2) Any individual certified by the 

American Board of Health Physics in 

Comprehensive Health Physics; 

American Board of Radiology; American 

Board of Nuclear Medicine; American 

Board of Science in Nuclear Medicine; 

Board of Pharmaceutical Specialties in 

Nuclear Pharmacy; American Board of 

Medical Physics in radiation oncology 

physics; Royal College of Physicians 

and Surgeons of Canada in nuclear 

medicine; American Osteopathic Board 

of Radiology; or American Osteopathic 

Board of Nuclear Medicine on or before 

October 24, 2005, need not comply with 

the training requirements of § 35.50 to 

be identified as a Radiation Safety 

Officer or as an Associate Radiation 

Safety Officer 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. 

(3) Any individual certified by the 

American Board of Radiology in 

therapeutic radiological physics, 

Roentgen ray and gamma ray physics, xray and radium physics, or radiological 

physics, or certified by the American 

Board of Medical Physics in radiation 

oncology physics, on or before October 

24, 2005, need not comply with the 

training requirements for an authorized 

medical physicist described in § 35.51, 

for those materials and uses that these 

individuals performed on or before 

October 24, 2005. 

(4) A Radiation Safety Officer, a 

medical physicist, or a nuclear 

pharmacist, who used only acceleratorproduced radioactive materials, discrete 

sources of radium-226, or both, for 

medical uses or in the practice of 

nuclear pharmacy at a Government 

agency or Federally recognized Indian 

Tribe before November 30, 2007, or at 

all other locations of use before August 

8, 2009, or an earlier date as noticed by 

the NRC, need not comply with the 

training requirements of § 35.50, § 35.51 

or § 35.55, respectively, when 

performing the same uses. A nuclear 

pharmacist, who prepared only 

radioactive drugs containing 

accelerator-produced radioactive 

materials, or a medical physicist, who 

used only accelerator-produced 

radioactive materials, at the locations 

and during the time period identified in 

this paragraph, qualifies as an 

authorized nuclear pharmacist or an 

authorized medical physicist, 

respectively, for those materials and 

uses performed before these dates, for 

the purposes of this chapter. 

(b)(1) Physicians, dentists, or 

podiatrists identified as authorized 

users for the medical use of byproduct 

material on a license issued by the 

Commission or an Agreement State, a 

permit issued by a Commission master 


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material licensee, a permit issued by a 

Commission or an Agreement State 

broad scope licensee, or a permit issued 

by a Commission master material 

license broad scope permittee on or 

before January 14, 2019, who perform 

only those medical uses for which they 

were authorized on or before that date 

need not comply with the training 

requirements of subparts D through H of 

this part. 

(2) Physicians, dentists, or podiatrists 

not identified as authorized users for the 

medical use of byproduct material on a 

license issued by the Commission or an 

Agreement State, a permit issued by a 

Commission master material licensee, a 

permit issued by a Commission or an 

Agreement State broad scope licensee, 

or a permit issued by a Commission 

master material license of broad scope 

on or before October 24, 2005, need not 

comply with the training requirements 

of subparts D through H of this part for 

those materials and uses that these 

individuals performed on or before 

October 24, 2005, as follows: 

(i) For uses authorized under § 35.100 

or § 35.200, or oral administration of 

sodium iodide I–131 requiring a written 

directive for imaging and localization 

purposes, a physician who was certified 

on or before October 24, 2005, in 

nuclear medicine by the American 

Board of Nuclear Medicine; diagnostic 

radiology by the American Board of 

Radiology; diagnostic radiology or 

radiology by the American Osteopathic 

Board of Radiology; nuclear medicine 

by the Royal College of Physicians and 

Surgeons of Canada; or American 

Osteopathic Board of Nuclear Medicine 

in nuclear medicine; 

(ii) For uses authorized under 

§ 35.300, a physician who was certified 

on or before October 24, 2005, by the 

American Board of Nuclear Medicine; 

the American Board of Radiology in 

radiology, therapeutic radiology, or 

radiation oncology; nuclear medicine by 

the Royal College of Physicians and 

Surgeons of Canada; or the American 

Osteopathic Board of Radiology after 

1984; 

(iii) For uses authorized under 

§ 35.400 or § 35.600, a physician who 

was certified on or before October 24, 

2005, in radiology, therapeutic 

radiology or radiation oncology by the 

American Board of Radiology; radiation 

oncology by the American Osteopathic 

Board of Radiology; radiology, with 

specialization in radiotherapy, as a 

British ‘‘Fellow of the Faculty of 

Radiology’’ or ‘‘Fellow of the Royal 

College of Radiology’’; or therapeutic 

radiology by the Canadian Royal College 

of Physicians and Surgeons; and 

(iv) For uses authorized under 

§ 35.500, a physician who was certified 

on or before October 24, 2005, in 

radiology, diagnostic radiology, 

therapeutic radiology, or radiation 

oncology by the American Board of 

Radiology; nuclear medicine by the 

American Board of Nuclear Medicine; 

diagnostic radiology or radiology by the 

American Osteopathic Board of 

Radiology; or nuclear medicine by the 

Royal College of Physicians and 

Surgeons of Canada. 

(3) Physicians, dentists, or podiatrists 

who used only accelerator-produced 

radioactive materials, discrete sources of 

radium-226, or both, for medical uses 

performed at a Government agency or 

Federally recognized Indian Tribe 

before November 30, 2007, or at all 

other locations of use before August 8, 

2009, or an earlier date as noticed by the 

NRC, need not comply with the training 

requirements of subparts D through H of 

this part when performing the same 

medical uses. A physician, dentist, or 

podiatrist, who used only acceleratorproduced radioactive materials, discrete 

sources of radium-226, or both, for 

medical uses at the locations and time 

period identified in this paragraph, 

qualifies as an authorized user for those 

materials and uses performed before 

these dates, for the purposes of this 

chapter. 

* * * * * 

■ 19. Revise § 35.65 to read as follows: 

§ 35.65 Authorization for calibration, 

transmission, and reference sources. 

(a) Any person authorized by § 35.11 

for medical use of byproduct material 

may receive, possess, and use any of the 

following byproduct material for check, 

calibration, transmission, and reference 

use: 

(1) Sealed sources, not exceeding 1.11 

GBq (30 mCi) each, manufactured and 

distributed by a person licensed under 

§ 32.74 of this chapter or equivalent 

Agreement State regulations; 

(2) Sealed sources, not exceeding 1.11 

GBq (30 mCi) each, redistributed by a 

licensee authorized to redistribute the 

sealed sources manufactured and 

distributed by a person licensed under 

§ 32.74 of this chapter or equivalent 

Agreement State regulations, providing 

the redistributed sealed sources are in 

the original packaging and shielding 

and are accompanied by the 

manufacturer’s approved instructions; 

(3) Any byproduct material with a 

half-life not longer than 120 days in 

individual amounts not to exceed 0.56 

GBq (15 mCi); 

(4) Any byproduct material with a 

half-life longer than 120 days in 

individual amounts not to exceed the 

smaller of 7.4 MBq (200 mCI) or 1000 

times the quantities in appendix B of 

part 30 of this chapter; or 

(5) Technetium-99m in amounts as 

needed. 

(b) Byproduct material in sealed 

sources authorized by this provision 

shall not be: 

(1) Used for medical use as defined in 

§ 35.2 except in accordance with the 

requirements in § 35.500; or 

(2) Combined (i.e., bundled or 

aggregated) to create an activity greater 

than the maximum activity of any single 

sealed source authorized under this 

section. 

(c) A licensee using calibration, 

transmission, and reference sources in 

accordance with the requirements in 

paragraph (a) or (b) of this section need 

not list these sources on a specific 

medical use license. 

■ 20. In § 35.190, revise paragraphs (a) 

introductory text and (c)(2) to read as 

follows: 

§ 35.190 Training for uptake, dilution, and 

excretion studies. 

* * * * * 

(a) Is certified by a medical specialty 

board whose certification process has 

been recognized by the Commission or 

an Agreement State. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page. To 

have its certification process recognized, 

a specialty board shall require all 

candidates for certification to: 

* * * * * 

(c) * * * 

(2) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraph (c)(1) of this section and is 

able to independently fulfill the 

radiation safety-related duties as an 

authorized user for the medical uses 

authorized under § 35.100. The 

attestation must be obtained from either: 

(i) A preceptor authorized user who 

meets the requirements in § 35.57, 

§ 35.190, § 35.290, or § 35.390, or 

equivalent Agreement State 

requirements; or 

(ii) A residency program director who 

affirms in writing that the attestation 

represents the consensus of the 

residency program faculty where at least 

one faculty member is an authorized 

user who meets the requirements in 

§ 35.57, § 35.190, § 35.290, or § 35.390, 

or equivalent Agreement State 

requirements, and concurs with the 

attestation provided by the residency 

program director. The residency training 

program must be approved by the 

Residency Review Committee of the 


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2Experience with at least three cases in Category 

(G)(2) also satisfies the requirement in Category 

(G)(1). 

Accreditation Council for Graduate 

Medical Education or the Royal College 

of Physicians and Surgeons of Canada or 

the Council on Postdoctoral Training of 

the American Osteopathic Association 

and must include training and 

experience specified in paragraph (c)(1) 

of this section. 

■ 21. In § 35.204, revise paragraph (b) 

and add paragraph (e) to read as follows: 

§ 35.204 Permissible molybdenum-99, 

strontium-82, and strontium-85 

concentrations. 

* * * * * 

(b) A licensee that uses molybdenum99/technetium-99m generators for 

preparing a technetium-99m 

radiopharmaceutical shall measure the 

molybdenum-99 concentration in each 

eluate from a generator to demonstrate 

compliance with paragraph (a) of this 

section. 

* * * * * 

(e) The licensee shall report any 

measurement that exceeds the limits in 

paragraph (a) of this section at the time 

of generator elution, in accordance with 

§ 35.3204. 

■ 22. In § 35.290, revise paragraphs (a) 

introductory text, (c)(1)(ii) introductory 

text, and (c)(2) to read as follows: 

§ 35.290 Training for imaging and 

localization studies. 

* * * * * 

(a) Is certified by a medical specialty 

board whose certification process has 

been recognized by the Commission or 

an Agreement State. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page. To 

have its certification process recognized, 

a specialty board shall require all 

candidates for certification to: 

* * * * * 

(c)(1) * * * 

(ii) Work experience, under the 

supervision of an authorized user who 

meets the requirements in § 35.57, 

§ 35.290, or §§ 35.390 and 

35.290(c)(1)(ii)(G), or equivalent 

Agreement State requirements. An 

authorized nuclear pharmacist who 

meets the requirements in § 35.55 or 

§ 35.57 may provide the supervised 

work experience for paragraph 

(c)(1)(ii)(G) of this section. Work 

experience must involve— 

* * * * * 

(2) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraph (c)(1) of this section and is 

able to independently fulfill the 

radiation safety-related duties as an 

authorized user for the medical uses 

authorized under §§ 35.100 and 35.200. 

The attestation must be obtained from 

either: 

(i) A preceptor authorized user who 

meets the requirements in § 35.57, 

§ 35.290, or §§ 35.390 and 

35.290(c)(1)(ii)(G), or equivalent 

Agreement State requirements; or 

(ii) A residency program director who 

affirms in writing that the attestation 

represents the consensus of the 

residency program faculty where at least 

one faculty member is an authorized 

user who meets the requirements in 

§ 35.57, § 35.290, or §§ 35.390 and 

35.290(c)(1)(ii)(G), or equivalent 

Agreement State requirements, and 

concurs with the attestation provided by 

the residency program director. The 

residency training program must be 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education or the 

Royal College of Physicians and 

Surgeons of Canada or the Council on 

Postdoctoral Training of the American 

Osteopathic Association and must 

include training and experience 

specified in paragraph (c)(1) of this 

section. 

■ 23. In § 35.300, revise the introductory 

text to read as follows: 

§ 35.300 Use of unsealed byproduct 

material for which a written directive is 

required. 

A licensee may use any unsealed 

byproduct material identified in 

§ 35.390(b)(1)(ii)(G) prepared for 

medical use and for which a written 

directive is required that is— 

* * * * * 

■ 24. In § 35.390, revise paragraphs (a) 

introductory text, (b)(1)(ii)(G), and (b)(2) 

to read as follows: 

§ 35.390 Training for use of unsealed 

byproduct material for which a written 

directive is required. 

* * * * * 

(a) Is certified by a medical specialty 

board whose certification process has 

been recognized by the Commission or 

an Agreement State and who meets the 

requirements in paragraphs (b)(1)(ii)(G) 

of this section. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page. To be 

recognized, a specialty board shall 

require all candidates for certification 

to: 

* * * * * 

(b)(1) * * * 

(ii) * * * 

(G) Administering dosages of 

radioactive drugs to patients or human 

research subjects from the three 

categories in this paragraph. Radioactive 

drugs containing radionuclides in 

categories not included in this 

paragraph are regulated under 

§ 35.1000. This work experience must 

involve a minimum of three cases in 

each of the following categories for 

which the individual is requesting 

authorized user status— 

(1) Oral administration of less than or 

equal to 1.22 gigabecquerels (33 

millicuries) of sodium iodide I–131, for 

which a written directive is required; 

(2) Oral administration of greater than 

1.22 gigabecquerels (33 millicuries) of 

sodium iodide I–131; 2

(3) Parenteral administration of any 

radioactive drug that contains a 

radionuclide that is primarily used for 

its electron emission, beta radiation 

characteristics, alpha radiation 

characteristics, or photon energy of less 

than 150 keV, for which a written 

directive is required; and 

(2) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraph (b)(1) of this section and is 

able to independently fulfill the 

radiation safety-related duties as an 

authorized user for the medical uses 

authorized under § 35.300 for which the 

individual is requesting authorized user 

status. The attestation must be obtained 

from either: 

(i) A preceptor authorized user who 

meets the requirements in § 35.57, 

§ 35.390, or equivalent Agreement State 

requirements and has experience in 

administering dosages in the same 

dosage category or categories as the 

individual requesting authorized user 

status; or 

(ii) A residency program director who 

affirms in writing that the attestation 

represents the consensus of the 

residency program faculty where at least 

one faculty member is an authorized 

user who meets the requirements in 

§ 35.57, § 35.390, or equivalent 

Agreement State requirements, has 

experience in administering dosages in 

the same dosage category or categories 

as the individual requesting authorized 

user status, and concurs with the 

attestation provided by the residency 

program director. The residency training 

program must be approved by the 

Residency Review Committee of the 

Accreditation Council for Graduate 

Medical Education or the Royal College 

of Physicians and Surgeons of Canada or 

the Council on Postdoctoral Training of 

the American Osteopathic Association 


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and must include training and 

experience specified in paragraph (b)(1) 

of this section. 

* * * * * 

■ 25. In § 35.392, revise paragraphs (a) 

and (c)(3) to read as follows: 

§ 35.392 Training 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). 

* * * * * 

(a) Is certified by a medical specialty 

board whose certification process 

includes all of the requirements in 

paragraphs (c)(1) and (2) of this section 

and whose certification process has 

been recognized by the Commission or 

an Agreement State. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page; or 

* * * * * 

(c) * * * 

(3) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraphs (c)(1) and (2) of this section, 

and is able to independently fulfill the 

radiation safety-related duties as an 

authorized user for oral administration 

of less than or equal to 1.22 

gigabecquerels (33 millicuries) of 

sodium iodide I–131 for medical uses 

authorized under § 35.300. The 

attestation must be obtained from either: 

(i) A preceptor authorized user who 

meets the requirements in § 35.57, 

§ 35.390, § 35.392, § 35.394, or 

equivalent Agreement State 

requirements and has experience in 

administering dosages as specified in 

§ 35.390(b)(1)(ii)(G)(1) or (2); or 

(ii) A residency program director who 

affirms in writing that the attestation 

represents the consensus of the 

residency program faculty where at least 

one faculty member is an authorized 

user who meets the requirements in 

§ 35.57, § 35.390, § 35.392, § 35.394, or 

equivalent Agreement State 

requirements, has experience in 

administering dosages as specified in 

§ 35.390(b)(1)(ii)(G)(1) or (2), and 

concurs with the attestation provided by 

the residency program director. The 

residency training program must be 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education or the 

Royal College of Physicians and 

Surgeons of Canada or the Council on 

Postdoctoral Training of the American 

Osteopathic Association and must 

include training and experience 

specified in paragraphs (c)(1) and (2) of 

this section. 

■ 26. In § 35.394, revise paragraphs (a) 

and (c)(3) to read as follows: 

§ 35.394 Training for the oral 

administration of sodium iodide I–131 

requiring a written directive in quantities 

greater than 1.22 gigabecquerels (33 

millicuries). 

* * * * * 

(a) Is certified by a medical specialty 

board whose certification process 

includes all of the requirements in 

paragraphs (c)(1) and (2) of this section, 

and whose certification has been 

recognized by the Commission or an 

Agreement State. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page; or 

* * * * * 

(c) * * * 

(3) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraphs (c)(1) and (2) of this section, 

and is able to independently fulfill the 

radiation safety-related duties as an 

authorized user for oral administration 

of greater than 1.22 gigabecquerels (33 

millicuries) of sodium iodide I–131 for 

medical uses authorized under § 35.300. 

The attestation must be obtained from 

either: 

(i) A preceptor authorized user who 

meets the requirements in § 35.57, 

§ 35.390, § 35.394, or equivalent 

Agreement State requirements, and has 

experience in administering dosages as 

specified in § 35.390(b)(1)(ii)(G)(2); or 

(ii) A residency program director who 

affirms in writing that the attestation 

represents the consensus of the 

residency program faculty where at least 

one faculty member is an authorized 

user who meets the requirements in 

§ 35.57, § 35.390, § 35.394, or equivalent 

Agreement State requirements, has 

experience in administering dosages as 

specified in § 35.390(b)(1)(ii)(G)(2), and 

concurs with the attestation provided by 

the residency program director. The 

residency training program must be 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education or the 

Royal College of Physicians and 

Surgeons of Canada or the Council on 

Postdoctoral Training of the American 

Osteopathic Association and must 

include training and experience 

specified in paragraphs (c)(1) and (2) of 

this section. 

■ 27. Revise § 35.396 to read as follows: 

§ 35.396 Training for the parenteral 

administration of unsealed byproduct 

material requiring a written directive. 

(a) Except as provided in § 35.57, the 

licensee shall require an authorized user 

for the parenteral administration 

requiring a written directive, to be a 

physician who— 

(1) Is an authorized user under 

§ 35.390 for uses listed in 

§ 35.390(b)(1)(ii)(G)(3), or equivalent 

Agreement State requirements; or 

(2) Is an authorized user under 

§ 35.490, § 35.690, or equivalent 

Agreement State requirements, and who 

meets the requirements in paragraph (b) 

of this section; or 

(3) Is certified by a medical specialty 

board whose certification process has 

been recognized by the Commission or 

an Agreement State under § 35.490 or 

§ 35.690, and who meets the 

requirements in paragraph (b) of this 

section. 

(b) The physician— 

(1) Has successfully completed 80 

hours of classroom and laboratory 

training, applicable to parenteral 

administrations listed in 

§ 35.390(b)(1)(ii)(G)(3). The training 

must include— 

(i) Radiation physics and 

instrumentation; 

(ii) Radiation protection; 

(iii) Mathematics pertaining to the use 

and measurement of radioactivity; 

(iv) Chemistry of byproduct material 

for medical use; and 

(v) Radiation biology; and 

(2) Has work experience, under the 

supervision of an authorized user who 

meets the requirements in § 35.57, 

§ 35.390, § 35.396, or equivalent 

Agreement State requirements, in the 

parenteral administrations listed in 

§ 35.390(b)(1)(ii)(G)(3). A supervising 

authorized user who meets the 

requirements in § 35.390, § 35.396, or 

equivalent Agreement State 

requirements, must have experience in 

administering dosages in the same 

category or categories as the individual 

requesting authorized user status. The 

work experience must involve— 

(i) Ordering, receiving, and unpacking 

radioactive materials safely, and 

performing the related radiation 

surveys; 

(ii) Performing quality control 

procedures on instruments used to 

determine the activity of dosages, and 

performing checks for proper operation 

of survey meters; 

(iii) Calculating, measuring, and 

safely preparing patient or human 

research subject dosages; 

(iv) Using administrative controls to 

prevent a medical event involving the 

use of unsealed byproduct material; 

(v) Using procedures to contain 

spilled byproduct material safely, and 

using proper decontamination 

procedures; and 

(vi) Administering dosages to patients 

or human research subjects, that include 


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at least three cases of the parenteral 

administrations as specified in 

§ 35.390(b)(1)(ii)(G)(3); and 

(3) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraphs (b)(1) and (2) of this section, 

and is able to independently fulfill the 

radiation safety-related duties as an 

authorized user for the parenteral 

administration of unsealed byproduct 

material requiring a written directive. 

The attestation must be obtained from 

either: 

(i) A preceptor authorized user who 

meets the requirements in § 35.57, 

§ 35.390, § 35.396, or equivalent 

Agreement State requirements. A 

preceptor authorized user who meets 

the requirements in § 35.390, § 35.396, 

or equivalent Agreement State 

requirements, must have experience in 

administering dosages in the same 

category or categories as the individual 

requesting authorized user status; or 

(ii) A residency program director who 

affirms in writing that the attestation 

represents the consensus of the 

residency program faculty where at least 

one faculty member is an authorized 

user who meets the requirements in 

§ 35.57, § 35.390, § 35.396, or equivalent 

Agreement State requirements, has 

experience in administering dosages in 

the same dosage category or categories 

as the individual requesting authorized 

user status, and concurs with the 

attestation provided by the residency 

program director. The residency training 

program must be approved by the 

Residency Review Committee of the 

Accreditation Council for Graduate 

Medical Education or the Royal College 

of Physicians and Surgeons of Canada or 

the Council on Postdoctoral Training of 

the American Osteopathic Association 

and must include training and 

experience specified in paragraphs 

(b)(1) and (2) of this section. 

■ 28. Revise § 35.400 to read as follows: 

§ 35.400 Use of sources for manual 

brachytherapy. 

A licensee must use only 

brachytherapy sources: 

(a) Approved in the Sealed Source 

and Device Registry for manual 

brachytherapy medical use. The manual 

brachytherapy sources may be used for 

manual brachytherapy uses that are not 

explicitly listed in the Sealed Source 

and Device Registry, but must be used 

in accordance with the radiation safety 

conditions and limitations described in 

the Sealed Source and Device Registry; 

or 

(b) In research to deliver therapeutic 

doses for medical use in accordance 

with an active Investigational Device 

Exemption (IDE) application accepted 

by the U.S. Food and Drug 

Administration provided the 

requirements of § 35.49(a) are met. 

■ 29. Revise § 35.433 to read as follows: 

§ 35.433 Strontium-90 sources for 

ophthalmic treatments. 

(a) Licensees who use strontium-90 

for ophthalmic treatments must ensure 

that certain activities as specified in 

paragraph (b) of this section are 

performed by either: 

(1) An authorized medical physicist; 

or 

(2) An individual who: 

(i) is identified as an ophthalmic 

physicist on a specific medical use 

license issued by the Commission or an 

Agreement State; permit issued by a 

Commission or Agreement State broad 

scope medical use licensee; medical use 

permit issued by a Commission master 

material licensee; or permit issued by a 

Commission master material licensee 

broad scope medical use permittee; and 

(ii) holds a master’s or doctor’s degree 

in physics, medical physics, other 

physical sciences, engineering, or 

applied mathematics from an accredited 

college or university; and 

(iii) has successfully completed 1 year 

of full-time training in medical physics 

and an additional year of full-time work 

experience under the supervision of a 

medical physicist; and 

(iv) Has documented training in: 

(A) The creation, modification, and 

completion of written directives; 

(B) Procedures for administrations 

requiring a written directive; and 

(C) Performing the calibration 

measurements of brachytherapy sources 

as detailed in § 35.432. 

(b) The individuals who are identified 

in paragraph (a) of this section must: 

(1) Calculate the activity of each 

strontium-90 source that is used to 

determine the treatment times for 

ophthalmic treatments. The decay must 

be based on the activity determined 

under § 35.432; and 

(2) Assist the licensee in developing, 

implementing, and maintaining written 

procedures to provide high confidence 

that the administration is in accordance 

with the written directive. These 

procedures must include the 

frequencies that the individual meeting 

the requirements in paragraph (a) of this 

section will observe treatments, review 

the treatment methodology, calculate 

treatment time for the prescribed dose, 

and review records to verify that the 

administrations were in accordance 

with the written directives. 

(c) Licensees must retain a record of 

the activity of each strontium-90 source 

in accordance with § 35.2433. 

■ 30. In § 35.490, revise paragraphs (a) 

introductory text, (b)(1)(ii) introductory 

text, and (b)(3) to read as follows: 

§ 35.490 Training for use of manual 

brachytherapy sources. 

* * * * * 

(a) Is certified by a medical specialty 

board whose certification process has 

been recognized by the Commission or 

an Agreement State. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page. To 

have its certification process recognized, 

a specialty board shall require all 

candidates for certification to: 

* * * * * 

(b)(1) * * * 

(ii) 500 hours of work experience, 

under the supervision of an authorized 

user who meets the requirements in 

§ 35.57, § 35.490, or equivalent 

Agreement State requirements, at a 

medical facility authorized to use 

byproduct materials under § 35.400, 

involving— 

* * * * * 

(3) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraphs (b)(1) and (2) of this section 

and is able to independently fulfill the 

radiation safety-related duties as an 

authorized user of manual 

brachytherapy sources for the medical 

uses authorized under § 35.400. The 

attestation must be obtained from either: 

(i) A preceptor authorized user who 

meets the requirements in § 35.57, 

§ 35.490, or equivalent Agreement State 

requirements; or 

(ii) A residency program director who 

affirms in writing that the attestation 

represents the consensus of the 

residency program faculty where at least 

one faculty member is an authorized 

user who meets the requirements in 

§ 35.57, § 35.490, or equivalent 

Agreement State requirements, and 

concurs with the attestation provided by 

the residency program director. The 

residency training program must be 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education or the 

Royal College of Physicians and 

Surgeons of Canada or the Council on 

Postdoctoral Training of the American 

Osteopathic Association and must 

include training and experience 

specified in paragraphs (b)(1) and (2) of 

this section. 

■ 31. In § 35.491, revise paragraph (b)(3) 

to read as follows: 


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§ 35.491 Training for ophthalmic use of 

strontium-90. 

* * * * * 

(b) * * * 

(3) Has obtained written attestation, 

signed by a preceptor authorized user 

who meets the requirements in § 35.57, 

§ 35.490, § 35.491, or equivalent 

Agreement State requirements, that the 

individual has satisfactorily completed 

the requirements in paragraphs (b)(1) 

and (2) of this section and is able to 

independently fulfill the radiation 

safety-related duties as an authorized 

user of strontium-90 for ophthalmic use. 

■ 32. Revise § 35.500 to read as follows: 

§ 35.500 Use of sealed sources and 

medical devices for diagnosis. 

(a) A licensee must use only sealed 

sources that are not in medical devices 

for diagnostic medical uses if the sealed 

sources are approved in the Sealed 

Source and Device Registry for 

diagnostic medicine. The sealed sources 

may be used for diagnostic medical uses 

that are not explicitly listed in the 

Sealed Source and Device Registry but 

must be used in accordance with the 

radiation safety conditions and 

limitations described in the Sealed 

Source and Device Registry. 

(b) A licensee must only use medical 

devices containing sealed sources for 

diagnostic medical uses if both the 

sealed sources and medical devices are 

approved in the Sealed Source and 

Device Registry for diagnostic medical 

uses. The diagnostic medical devices 

may be used for diagnostic medical uses 

that are not explicitly listed in the 

Sealed Source and Device Registry but 

must be used in accordance with the 

radiation safety conditions and 

limitations described in the Sealed 

Source and Device Registry. 

(c) Sealed sources and devices for 

diagnostic medical uses may be used in 

research in accordance with an active 

Investigational Device Exemption (IDE) 

application accepted by the U.S. Food 

and Drug Administration provided the 

requirements of § 35.49(a) are met. 

■ 33. Revise § 35.590 to read as follows: 

§ 35.590 Training for use of sealed 

sources and medical devices for diagnosis. 

Except as provided in § 35.57, the 

licensee shall require the authorized 

user of a diagnostic sealed source or a 

device authorized under § 35.500 to be 

a physician, dentist, or podiatrist who— 

(a) Is certified by a specialty board 

whose certification process includes all 

of the requirements in paragraphs (c) 

and (d) of this section and whose 

certification has been recognized by the 

Commission or an Agreement State. The 

names of board certifications that have 

been recognized by the Commission or 

an Agreement State are posted on the 

NRC’s Medical Uses Licensee Toolkit 

web page; or 

(b) Is an authorized user for uses 

listed in § 35.200 or equivalent 

Agreement State requirements; or 

(c) Has completed 8 hours of 

classroom and laboratory training in 

basic radionuclide handling techniques 

specifically applicable to the use of the 

device. The training must include— 

(1) Radiation physics and 

instrumentation; 

(2) Radiation protection; 

(3) Mathematics pertaining to the use 

and measurement of radioactivity; and 

(4) Radiation biology; and 

(d) Has completed training in the use 

of the device for the uses requested. 

■ 34. Revise § 35.600 to read as follows: 

§ 35.600 Use of a sealed source in a 

remote afterloader unit, teletherapy unit, or 

gamma stereotactic radiosurgery unit. 

(a) A licensee must only use sealed 

sources: 

(1) Approved and as provided for in 

the Sealed Source and Device Registry 

in photon emitting remote afterloader 

units, teletherapy units, or gamma 

stereotactic radiosurgery units to deliver 

therapeutic doses for medical uses: or 

(2) In research involving photonemitting remote afterloader units, 

teletherapy units, or gamma stereotactic 

radiosurgery units in accordance with 

an active Investigational Device 

Exemption (IDE) application accepted 

by the U.S. Food and Drug 

Administration provided the 

requirements of § 35.49(a) are met. 

(b) A licensee must use photonemitting remote afterloader units, 

teletherapy units, or gamma stereotactic 

radiosurgery units: 

(1) Approved in the Sealed Source 

and Device Registry to deliver a 

therapeutic dose for medical use. These 

devices may be used for therapeutic 

medical treatments that are not 

explicitly provided for in the Sealed 

Source and Device Registry, but must be 

used in accordance with radiation safety 

conditions and limitations described in 

the Sealed Source and Device Registry; 

or 

(2) In research in accordance with an 

active Investigational Device Exemption 

(IDE) application accepted by the FDA 

provided the requirements of § 35.49(a) 

are met. 

■ 35. In § 35.610, revise paragraphs (d) 

and (g) to read as follows: 

§ 35.610 Safety procedures and 

instructions for remote afterloader units, 

teletherapy units, and gamma stereotactic 

radiosurgery units. 

* * * * * 

(d)(1) 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, a licensee shall ensure that vendor 

operational and safety training is 

provided to all individuals who will 

operate the unit. The vendor operational 

and safety training must be provided by 

the device manufacturer or by an 

individual certified by the device 

manufacturer to provide the operational 

and safety training. 

(2) A licensee shall provide 

operational and safety instructions 

initially and at least annually to all 

individuals who operate the unit at the 

facility, as appropriate to the 

individual’s assigned duties. The 

instructions shall include instruction 

in— 

(i) The procedures identified in 

paragraph (a)(4) of this section; and 

(ii) The operating procedures for the 

unit. 

* * * * * 

(g) A licensee shall retain a copy of 

the procedures required by paragraphs 

(a)(4) and (d)(2)(ii) of this section in 

accordance with § 35.2610. 

■ 36. In § 35.655, revise the section 

heading and paragraph (a) to read as 

follows: 

§ 35.655 Full-inspection servicing for 

teletherapy and gamma stereotactic 

radiosurgery units. 

(a) A licensee shall have each 

teletherapy unit and gamma stereotactic 

radiosurgery unit fully inspected and 

serviced during each source 

replacement to assure proper 

functioning of the source exposure 

mechanism and other safety 

components. The interval between each 

full-inspection servicing shall not 

exceed 5 years for each teletherapy unit 

and shall not exceed 7 years for each 

gamma stereotactic radiosurgery unit. 

* * * * * 

■ 37. In § 35.690, revise paragraphs (a) 

introductory text, (b)(1)(ii) introductory 

text, and (b)(3) to read as follows: 

§ 35.690 Training for use of remote 

afterloader units, teletherapy units, and 

gamma stereotactic radiosurgery units. 

* * * * * 

(a) Is certified by a medical specialty 

board whose certification process has 

been recognized by the Commission or 

an Agreement State and who meets the 

requirements in paragraph (c) of this 

section. The names of board 

certifications that have been recognized 

by the Commission or an Agreement 

State are posted on the NRC’s Medical 

Uses Licensee Toolkit web page. To 

have its certification process recognized, 


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a specialty board shall require all 

candidates for certification to: 

* * * * * 

(b)(1) * * * 

(ii) 500 hours of work experience, 

under the supervision of an authorized 

user who meets the requirements in 

§ 35.57, § 35.690, or equivalent 

Agreement State requirements, at a 

medical facility that is authorized to use 

byproduct materials in § 35.600, 

involving— 

* * * * * 

(3) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraphs (b)(1) and (2) and (c) of this 

section; and is able to independently 

fulfill the radiation safety-related duties 

as an authorized user of each type of 

therapeutic medical unit for which the 

individual is requesting authorized user 

status. The attestation must be obtained 

from either: 

(i) A preceptor authorized user who 

meets the requirements in § 35.57, 

§ 35.690, or equivalent Agreement State 

requirements for the type(s) of 

therapeutic medical unit for which the 

individual is requesting authorized user 

status; or 

(ii) A residency program director who 

affirms in writing that the attestation 

represents the consensus of the 

residency program faculty where at least 

one faculty member is an authorized 

user who meets the requirements in 

§ 35.57, § 35.690, or equivalent 

Agreement State requirements, for the 

type(s) of therapeutic medical unit for 

which the individual is requesting 

authorized user status, and concurs with 

the attestation provided by the 

residency program director. The 

residency training program must be 

approved by the Residency Review 

Committee of the Accreditation Council 

for Graduate Medical Education or the 

Royal College of Physicians and 

Surgeons of Canada or the Council on 

Postdoctoral Training of the American 

Osteopathic Association and must 

include training and experience 

specified in paragraphs (b)(1) and (2) of 

this section. 

* * * * * 

■ 38. In § 35.2024, add paragraph (c) to 

read as follows: 

§ 35.2024 Records of authority and 

responsibilities for radiation protection 

programs. 

* * * * * 

(c) For each Associate Radiation 

Safety Officer appointed under 

§ 35.24(b), the licensee shall retain, for 

5 years after the Associate Radiation 

Safety Officer is removed from the 

license, a copy of the written document 

appointing the Associate Radiation 

Safety Officer signed by the licensee’s 

management. 

■ 39. Revise § 35.2310 to read as 

follows: 

§ 35.2310 Records of safety instruction. 

A licensee shall maintain a record of 

safety instructions required by §§ 35.310 

and 35.410 and the operational and 

safety instructions required by § 35.610 

for 3 years. The record must include a 

list of the topics covered, the date of the 

instruction, the name(s) of the 

attendee(s), and the name(s) of the 

individual(s) who provided the 

instruction. 

■ 40. In § 35.2655, revise the section 

heading and paragraph (a) to read as 

follows: 

§ 35.2655 Records of full-inspection 

servicing for teletherapy and gamma 

stereotactic radiosurgery units. 

(a) A licensee shall maintain a record 

of the full-inspection servicing for 

teletherapy and gamma stereotactic 

radiosurgery units required by § 35.655 

for the duration of the use of the unit. 

* * * * * 

■ 41. In § 35.3045, revise paragraph (a) 

to read as follows: 

§ 35.3045 Report and notification of a 

medical event. 

(a) A licensee shall report any event 

as a medical event, except for an event 

that results from patient intervention, in 

which— 

(1) The administration of byproduct 

material or radiation from byproduct 

material, except permanent implant 

brachytherapy, results in— 

(i) A dose that differs from the 

prescribed dose or dose that would have 

resulted from the prescribed dosage by 

more than 0.05 Sv (5 rem) effective dose 

equivalent, 0.5 Sv (50 rem) to an organ 

or tissue, or 0.5 Sv (50 rem) shallow 

dose equivalent to the skin; and 

(A) The total dose delivered differs 

from the prescribed dose by 20 percent 

or more; 

(B) The total dosage delivered differs 

from the prescribed dosage by 20 

percent or more or falls outside the 

prescribed dosage range; or 

(C) The fractionated dose delivered 

differs from the prescribed dose for a 

single fraction, by 50 percent or more. 

(ii) A dose that exceeds 0.05 Sv (5 

rem) effective dose equivalent, 0.5 Sv 

(50 rem) to an organ or tissue, or 0.5 Sv 

(50 rem) shallow dose equivalent to the 

skin from any of the following— 

(A) An administration of a wrong 

radioactive drug containing byproduct 

material or the wrong radionuclide for 

a brachytherapy procedure; 

(B) An administration of a radioactive 

drug containing byproduct material by 

the wrong route of administration; 

(C) An administration of a dose or 

dosage to the wrong individual or 

human research subject; 

(D) An administration of a dose or 

dosage delivered by the wrong mode of 

treatment; or 

(E) A leaking sealed source. 

(iii) A dose to the skin or an organ or 

tissue other than the treatment site that 

exceeds by: 

(A) 0.5 Sv (50 rem) or more the 

expected dose to that site from the 

procedure if the administration had 

been given in accordance with the 

written directive prepared or revised 

before administration; and 

(B) 50 percent or more the expected 

dose to that site from the procedure if 

the administration had been given in 

accordance with the written directive 

prepared or revised before 

administration. 

(2) For permanent implant 

brachytherapy, the administration of 

byproduct material or radiation from 

byproduct material (excluding sources 

that were implanted in the correct site 

but migrated outside the treatment site) 

that results in— 

(i) The total source strength 

administered differing by 20 percent or 

more from the total source strength 

documented in the post-implantation 

portion of the written directive; 

(ii) The total source strength 

administered outside of the treatment 

site exceeding 20 percent of the total 

source strength documented in the postimplantation portion of the written 

directive; or 

(iii) An administration that includes 

any of the following: 

(A) The wrong radionuclide; 

(B) The wrong individual or human 

research subject; 

(C) Sealed source(s) implanted 

directly into a location discontiguous 

from the treatment site, as documented 

in the post-implantation portion of the 

written directive; or 

(D) A leaking sealed source resulting 

in a dose that exceeds 0.5 Sv (50 rem) 

to an organ or tissue. 

* * * * * 

■ 42. Add § 35.3204 to subpart M to 

read as follows: 

§ 35.3204 Report and notification for an 

eluate exceeding permissible molybdenum99, strontium-82, and strontium-85 

concentrations. 

(a) The licensee shall notify by 

telephone the NRC Operations Center 

and the distributor of the generator 


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within 7 calendar days after discovery 

that an eluate exceeded the permissible 

concentration listed in § 35.204(a) at the 

time of generator elution. The telephone 

report to the NRC must include the 

manufacturer, model number, and serial 

number (or lot number) of the generator; 

the results of the measurement; the date 

of the measurement; whether dosages 

were administered to patients or human 

research subjects, when the distributor 

was notified, and the action taken. 

(b) By an appropriate method listed in 

§ 30.6(a) of this chapter, the licensee 

shall submit a written report to the 

appropriate NRC Regional Office listed 

in § 30.6 of this chapter within 30 

calendar days after discovery of an 

eluate exceeding the permissible 

concentration at the time of generator 

elution. The written report must include 

the action taken by the licensee; the 

patient dose assessment; the 

methodology used to make this dose 

assessment if the eluate was 

administered to patients or human 

research subjects; and the probable 

cause and an assessment of failure in 

the licensee’s equipment, procedures or 

training that contributed to the 

excessive readings if an error occurred 

in the licensee’s breakthrough 

determination; and the information in 

the telephone report as required by 

paragraph (a) of this section. 

Dated at Rockville, Maryland, this 6th day 

of July 2018. 

For the Nuclear Regulatory Commission. 

Russell E. Chazell, 

Acting Secretary of the Commission. 

[FR Doc. 2018–14852 Filed 7–13–18; 8:45 am] 

BILLING CODE 7590–01–P 


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