This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

33901 

Vol. 74, No. 133 

Tuesday, July 14, 2009 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 35 

[NRC–2009–0098] 

RIN 3150–AI59 

Medical Use of Byproduct Material— 

Authorized User Clarification 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Direct final rule. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) is amending its 

regulations to clarify that individuals 

who do not need to comply with the 

training and experience requirements as 

described in the applicable regulations 

for the medical use of byproduct 

material (i.e., are ‘‘grandfathered’’) may 

serve as preceptors and work experience 

supervisors for individuals seeking 

recognition on NRC licenses for the 

same medical uses of byproduct 

material. The regulations that govern the 

medical use of byproduct material were 

amended in their entirety in 2002 and 

again in 2005. Currently, individuals 

who were identified on an NRC or 

Agreement State license or permit 

before the regulations were amended do 

not need to requalify by meeting the 

training and experience (T&E) 

requirements of the applicable 

regulations. When the regulations were 

revised, the NRC intended that those 

authorized individuals would also be 

able to serve as preceptors and work 

experience supervisors. However, the 

regulations as they are currently written 

do not specifically state that 

grandfathered individuals can be work 

experience supervisors and preceptors. 

This direct final rule amends the 

regulations to clarify that all individuals 

grandfathered under the applicable 

regulations may serve as preceptors and 

work experience supervisors for 

individuals seeking recognition on an 

NRC license for the same uses. 

Additionally, several minor 

administrative changes are included in 

this rulemaking. 

DATES: The final rule is effective 

September 28, 2009, unless a significant 

adverse comment is received by August 

13, 2009. A significant adverse comment 

is a comment where the commenter 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. If the 

rule is withdrawn, timely notice will be 

published in the Federal Register. 

ADDRESSES: Please include the number 

RIN 3150–AI59 in the subject line of 

your comments. Comments on 

rulemakings submitted in writing or in 

electronic form will be made available 

to the public in their entirety on the 

NRC’s Web site in the Agencywide 

Documents Access and Management 

System (ADAMS) and at http:// 

www.regulations.gov. Personal 

information, such as your name, 

address, telephone number, e-mail 

address, etc., will not be removed from 

your submission. You may submit 

comments by any one of the following 

methods: 

Federal e-Rulemaking portal: Go to 

http://www.regulations.gov and search 

for documents filed under Docket ID 

NRC–2009–0098 and follow instructions 

for submitting comments. Address 

questions about NRC dockets to Carol 

Gallagher at 301–492–3668, e-mail 

Carol.Gallagher@nrc.gov. 

Mail comments to: Secretary, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, ATTN: 

Rulemakings and Adjudications Staff. 

E-mail comments to: 

Rulemaking.Comments@nrc.gov. If you 

do not receive a reply e-mail confirming 

that we have received your comments, 

contact us directly at 301–415–1677. 

Hand-deliver comments to: 11555 

Rockville Pike, Rockville, Maryland 

20852, between 7:30 a.m. and 4:15 p.m. 

Federal workdays. (Telephone 301–415– 

1677). 

Fax comments to: Secretary, U.S. 

Nuclear Regulatory Commission at 301– 

415–1101. 

Publicly available documents related 

to this rulemaking may be viewed 

electronically on the public computers 

located at the NRC’s Public Document 

Room (PDR), Room O–1 F21, One White 

Flint North, 11555 Rockville Pike, 

Rockville, Maryland. The PDR 

reproduction contractor will copy 

documents for a fee. Selected 

documents, including any comments, 

may be viewed and downloaded via the 

e-Rulemaking Portal at http:// 

www.regulations.gov. 

Publicly available documents created 

or received at the NRC after November 

1, 1999, are available electronically at 

the NRC’s Electronic Reading Room at 

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

adams.html. From this site, the public 

can gain entry into ADAMS, which 

provides text and image files of NRC’s 

public documents. If you do not have 

access to ADAMS or if there are 

problems in accessing the documents 

located in ADAMS, contact the PDR 

Reference staff at 1–800–397–4209, 

301–415–4737 or by e-mail to 

pdr.resource@nrc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Edward M. Lohr, Office of Federal and 

State Materials and Environmental 

Management Programs, U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001, telephone 301–415– 

0253, e-mail—Edward.Lohr@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On April 24, 2002 (67 FR 20250), and 

again on March 30, 2005 (70 FR 16336), 

the NRC revised the T&E requirements 

contained in 10 CFR Part 35 for 

individuals seeking recognition on NRC 

medical licenses. Individuals who were 

authorized on a license or permit at the 

time that the 2002 and 2005 regulations 

went into effect were ‘‘grandfathered’’ 

under § 35.57 (i.e., did not need to 

comply with the new training and 

experience requirements). However, 

§ 35.57 does not specifically state that 

those individuals may also provide 

work experience supervision or 

preceptor attestations for individuals 

seeking recognition for the same uses on 

NRC licenses or permits. 

Discussion 

The current language of the T&E 

requirements contained in 10 CFR part 

35 is inconsistent as to whether 

individuals grandfathered under § 35.57 

may serve as preceptors and/or work 

experience supervisors. Under § 35.50, 

Training for Radiation Safety Officer, 

any individual who is identified as the 


hsrobinson on PROD1PC76 with RULES
33902 Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Rules and Regulations 

Radiation Safety Officer on an NRC or 

Agreement State license or permit may 

serve as a preceptor or work experience 

supervisor; however, only those 

physicians who meet the current 

requirements for authorized users (AUs) 

may serve as work experience 

supervisors. Under § 35.51, ‘‘Training 

for an authorized medical physicist,’’ 

work experience may be obtained under 

the supervision of an individual who 

meets the requirements for an 

authorized medical physicist (AMP) for 

the type of use for which the individual 

is seeking authorization; however, 

individuals seeking recognition on an 

NRC license or permit must obtain a 

written attestation that may be signed 

only by a preceptor AMP who meets the 

current requirements. Section 35.55 

does not limit work experience 

supervisors or preceptors to individuals 

meeting the current requirements, as it 

provides that supervised practical 

experience may be in ‘‘a nuclear 

pharmacy,’’ and the written attestation 

may be signed by ‘‘a preceptor 

authorized nuclear pharmacist.’’ With 

regard to AUs, under §§ 35.190, 35.290, 

35.390, 35.392, 35.394, 35.396, 35.490, 

and 35.690, only those AUs who meet 

the current requirements may serve as 

either preceptors or work experience 

supervisors. However, under § 35.491, 

while the preceptor must be an AU who 

meets the current requirements, the 

regulation provides that supervised 

clinical training may be under the 

supervision of ‘‘an authorized user.’’ 

The SUPPLEMENTARY INFORMATION

section of the preamble to the final rule 

amending 10 CFR part 35 in 2005 

indicated that it was the NRC’s intent to 

permit individuals grandfathered under 

§ 35.57 to serve as work experience 

supervisors and preceptors for 

individuals seeking recognition on NRC 

licenses or permits for the same uses. 

Specifically, in the Summary of Public 

Comments and Responses to Comments, 

a comment from the public on the 

proposed rule stated that clarification 

was needed for grandfathering AMPs so 

‘‘there could be an initial pool of AMPs 

to serve as preceptors.’’ In response to 

this comment, the NRC stated: ‘‘These 

individuals, who have been identified 

on a license, would also be able to serve 

as preceptors for individuals to become 

AMPs.’’ However, § 35.51, ‘‘Training for 

an authorized medical physicist,’’ was 

not revised to implement that intent. 

Specifically, § 35.51(b)(2) states that 

individuals seeking recognition on an 

NRC license or permit must have 

obtained a written attestation that ‘‘must 

be signed by a preceptor authorized 

medical physicist who meets the 

requirements in section 35.51, or 

equivalent Agreement State 

requirements for an authorized medical 

physicist * * *.’’ 

Although the response to the 

comment addresses only AMPs, it was 

the NRC’s intent to allow other 

individuals authorized on NRC and 

Agreement State licenses and permits to 

serve as both preceptors and work 

experience supervisors for individuals 

seeking recognition on NRC licenses or 

permits for the same uses. If individuals 

grandfathered under § 35.57 are unable 

to provide attestations and work 

experience supervision for applicants, 

there will not be a sufficient pool of 

professionals to provide attestations or 

work experience supervision for new 

applicants to become authorized 

individuals on NRC medical use 

licenses. This may create a serious 

shortage of authorized individuals in 

the medical community, which may 

result in a negative impact on health 

care. Therefore, the NRC is revising the 

T&E regulations to implement its intent 

that all individuals grandfathered under 

§ 35.57 may serve as preceptors and 

work experience supervisors for 

individuals seeking recognition on NRC 

licenses or permits for the same uses. 

Discussion of Amendments by Section 

1. Section 35.50 Training for 

Radiation Safety Officer. 

This section is amended to clarify that 

radiation safety officers may have 

practical training and/or supervised 

experience in medical physics under the 

direction of physicians who meet the 

requirements for authorized users in 

§ 35.57. 

2. Section 35.51 Training for an 

authorized medical physicist. 

This section is amended to clarify that 

authorized medical physicists may have 

practical training and/or supervised 

experience in medical physics under the 

direction of physicians who meet the 

requirements for authorized users in 

§ 35.57 and that preceptors for medical 

physicists may be medical physicists 

who meet the requirements in § 35.57. 

Additionally, a minor administrative 

change is made for clarification. 

3. Section 35.57 Training for 

experienced Radiation Safety Officer, 

teletherapy or medical physicist, 

authorized medical physicist, 

authorized user, nuclear pharmacist, 

and authorized nuclear pharmacist. 

This section is amended to clarify that 

individuals who need not comply with 

training requirements as described in 

§ 35.57 may serve as preceptors for, and 

supervisors of, applicants seeking 

authorization on NRC licenses for the 

same uses for which these individuals 

are authorized. 

4. Section 35.190 Training for uptake, 

dilution, and excretion studies. 

This section is amended to clarify that 

authorized users may have work 

experience under the supervision of 

authorized users who meet the 

requirements in § 35.57 and may obtain 

written attestations signed by preceptor 

authorized users who meet the 

requirements in § 35.57. 

5. Section 35.290 Training for imaging 

and localization studies. 

This section is amended to clarify that 

authorized users may have work 

experience under the supervision of 

authorized users who meet the 

requirements in § 35.57 and obtain 

written attestations signed by preceptor 

authorized users who meet the 

requirements in § 35.57. Additionally, a 

minor administrative change is made to 

the language to make it consistent 

throughout the section. 

6. Section 35.390 Training for use of 

unsealed byproduct material for which 

a written directive is required. 

This section is amended to clarify that 

authorized users may have work 

experience under the supervision of 

authorized users who meet the 

requirements in § 35.57 and may obtain 

written attestations signed by preceptor 

authorized users who meet the 

requirements in § 35.57. 

7. 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). 

This section is amended to clarify that 

authorized users may have work 

experience under the supervision of 

authorized users who meet the 

requirements in § 35.57 and may obtain 

written attestations signed by preceptor 

authorized users who meet the 

requirements in § 35.57. Additionally, a 

minor administrative change is made for 

clarification. 

8. 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). 

This section is amended to clarify that 

authorized users may have work 

experience under the supervision of 

authorized users who meet the 

requirements in § 35.57 and may obtain 

written attestations signed by preceptor 

authorized users who meet the 

requirements in § 35.57. 

9. Section 35.396 Training for the 

parenteral administration of unsealed 

byproduct material requiring a written 

directive. 


hsrobinson on PROD1PC76 with RULES
Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Rules and Regulations 33903 

This section is amended to clarify that 

authorized users may have work 

experience under the supervision of 

authorized users who meet the 

requirements in § 35.57 and may obtain 

written attestations signed by preceptor 

authorized users who meet the 

requirements in § 35.57. 

10. Section 35.490 Training for use of 

manual brachytherapy sources. 

This section is amended to clarify that 

authorized users may have work 

experience under the supervision of 

authorized users who meet the 

requirements in § 35.57, may have 

supervised clinical experience in 

radiation oncology under authorized 

users who meet the requirements in 

§ 35.57, and may obtain written 

attestations signed by preceptor 

authorized users who meet the 

requirements in § 35.57. Additionally, a 

minor administrative change is made for 

clarification. 

11. Section 35.491 Training for 

ophthalmic use of strontium-90. 

This section is amended to clarify that 

authorized users may obtain written 

attestations signed by preceptor 

authorized users who meet the 

requirements in § 35.57. Additionally, a 

minor error in the text of § 35.491(b)(3) 

is corrected to clarify that the preceptor 

authorized user does not need to attest 

that the individual has completed the 

requirements in paragraph (a) and (b), 

but only that the individual has 

completed the requirements in 

paragraph (b). 

12. Section 35.690 Training for use of 

remote afterloader units, teletherapy 

units, and gamma stereotactic 

radiosurgery units. 

This section is amended to clarify that 

authorized users may have work 

experience under the supervision of 

authorized users who meet the 

requirements in § 35.57, may have 

supervised clinical experience in 

radiation therapy under authorized 

users who meet the requirements in 

§ 35.57, and may obtain written 

attestations signed by preceptor 

authorized users who meet the 

requirements in § 35.57. Additionally, a 

minor administrative change is made for 

clarification. 

Procedural Background 

The amendments contained in this 

rule will become effective on September 

28, 2009. However, if the NRC receives 

a significant adverse comment by 

August 13, 2009, then the NRC will 

publish a document that withdraws this 

action and will address the comments 

received in a final rule as a response to 

the companion proposed rule published 

elsewhere in this issue of the Federal 

Register. Absent significant 

modifications to the proposed revisions 

requiring republication, the NRC will 

not initiate a second comment period on 

this action. 

A significant adverse comment is a 

comment where the commenter 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. A 

comment is adverse and significant if: 

(1) The comment opposes the rule and 

provides a reason sufficient to require a 

substantive response in a notice-andcomment process. For example, a 

substantive response is required when: 

(a) The comment causes the NRC staff 

to reevaluate (or reconsider) its position 

or conduct additional analysis; 

(b) The comment raises an issue 

serious enough to warrant a substantive 

response to clarify or complete the 

record; or 

(c) The comment raises a relevant 

issue that was not previously addressed 

or considered by the NRC staff. 

(2) The comment proposes a change 

or an addition to the rule, and it is 

apparent that the rule would be 

ineffective or unacceptable without 

incorporation of the change or addition. 

(3) The comment causes the staff to 

make a change (other than editorial) to 

the rule. 

Agreement State Compatibility 

Under the ‘‘Policy Statement on 

Adequacy and Compatibility of 

Agreement State Programs’’ approved by 

the Commission on June 30, 1997 (62 FR 

46517), specific requirements within 

this rule should be adopted by 

Agreement States for purposes of 

compatibility or because of health and 

safety significance. Implementing 

procedures for the Policy Statement 

establish specific categories which have 

been applied to categorize the 

requirements in 10 CFR parts 32 and 35. 

A Compatibility Category ‘‘A’’ 

designation means the requirement is a 

basic radiation protection standard or 

deals with related definitions, signs, 

labels, or terms necessary for a common 

understanding of radiation protection 

principles. Compatibility Category ‘‘A’’ 

designated Agreement State 

requirements should be essentially 

identical to those of the NRC. A 

Compatibility Category ‘‘B’’ designation 

means the requirement has significant 

transboundary implications. 

Compatibility Category ’’B’’ designated 

Agreement State requirements should be 

essentially identical to those of the NRC. 

A Compatibility Category ‘‘C’’ 

designation means 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 

requirement need not be the same as 

NRC provided the essential objectives 

are met. A Compatibility Category ‘‘D’’ 

designation means the requirement does 

not have to be adopted by an Agreement 

State for purposes of compatibility. The 

Compatibility Category Health & Safety 

(H&S) identifies program elements that 

are not required for purposes of 

compatibility, but have particular health 

and safety significance. States should 

adopt the essential objectives of such 

program elements in order to maintain 

an adequate program. 

SUMMARY OF NRC RULES WITH COMPATIBILITY OR HEALTH AND SAFETY DESIGNATIONS UNDER THE PROPOSED RULE

COVERING 10 CFR PART 35 

Section Section title 

Category B 

§ 35.50 ....................... Training for Radiation Safety Officer. 

§ 35.51 ....................... Training for an authorized medical physicist. 

§ 35.57 ....................... Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 

§ 35.190 ..................... Training for uptake, dilution, and excretion studies. 

§ 35.290 ..................... Training for imaging and localization studies. 

§ 35.390 ..................... Training for use of unsealed byproduct material for which a written directive is required. 

§ 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). 


hsrobinson on PROD1PC76 with RULES
33904 Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Rules and Regulations 

SUMMARY OF NRC RULES WITH COMPATIBILITY OR HEALTH AND SAFETY DESIGNATIONS UNDER THE PROPOSED RULE

COVERING 10 CFR PART 35—Continued 

Section Section title 

§ 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). 

§ 35.396 ..................... Training for the parenteral administration of unsealed byproduct material requiring a written directive. 

§ 35.490 ..................... Training for use of manual brachytherapy sources. 

§ 35.491 ..................... Training for ophthalmic use of strontium-90. 

§ 35.690 ..................... Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. 

Plain Language 

The Presidential Memorandum ‘‘Plain 

Language in Government Writing’’ 

published June 10, 1998 (63 FR 31883), 

directed that the Government’s 

documents be in clear and accessible 

language. The NRC requests comments 

on this direct final rule specifically with 

respect to the clarity and effectiveness 

of the language used. Comments should 

be sent to the address listed under the 

ADDRESSES heading. 

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 direct final rule, the 

NRC is amending its regulations to 

clarify that individuals who do not need 

to comply with the training and 

experience requirements as described in 

§ 35.57 may serve as preceptors and 

work experience supervisors for 

individuals seeking recognition on NRC 

licenses or permits for the same medical 

uses of byproduct material. This action 

does not constitute the establishment of 

a standard that establishes generally 

applicable requirements. 

Environmental Impact: Categorical 

Exclusion 

The NRC has determined that this 

direct final rule is the type of action 

described in categorical exclusion 10 

CFR 51.22(c)(2). Therefore neither an 

environmental impact statement nor an 

environmental assessment has been 

prepared for this direct final rule. 

Paperwork Reduction Act Statement 

This direct final rule does not contain 

a new or amended information 

collection requirement subject to the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). Existing 

information collection requirements 

were approved by the Office of 

Management and Budget, approval 

number 3150–0010. 

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 request unless 

the requesting document displays a 

currently valid OMB control number. 

Regulatory Analysis 

A regulatory analysis has not been 

prepared for this direct final rule 

because this rule is considered a minor 

non-substantive amendment and it has 

no economic impact on NRC licensees 

or the public. This rule does not impose 

any new requirements. It only clarifies 

the rule language in several sections in 

10 CFR part 35. 

Regulatory Flexibility Certification 

In accordance with the Regulatory 

Flexibility Act of 1980 (5 U.S.C. 605(b)), 

the Commission certifies that this rule 

does not have a significant economic 

impact on a substantial number of small 

entities. The majority of companies that 

own these facilities do not fall within 

the scope of the definition of ‘‘small 

entities’’ set forth in the Regulatory 

Flexibility Act or the size standards 

established by the NRC (10 CFR 2.810). 

This rule does not impose any new 

requirements. It only clarifies the rule 

language in several sections in 10 CFR 

part 35. 

Backfit Analysis 

The NRC has determined that the 

backfit rule (§§ 50.109, 70.76, 72.62, or 

76.76) does not apply to this final rule 

because this amendment does not 

involve any provisions that would 

impose backfits as defined in 10 CFR 

Chapter I. Therefore, a backfit analysis 

is not required. 

Congressional Review Act 

In accordance with the Congressional 

Review Act of 1996, the NRC has 

determined that this action is not a 

major rule and has verified this 

determination with the Office of 

Information and Regulatory Affairs of 

OMB. 

List of Subjects in 10 CFR Part 35 

Byproduct material, Criminal 

penalties, Drugs, Health facilities, 

Health professions, Medical devices, 

Nuclear materials, Occupational safety 

and health, 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 part 35. 

PART 35—MEDICAL USE OF 

BYPRODUCT MATERIAL 

■ 1. The authority citation for Part 35 

continues to read as follows: 

Authority: Secs. 81, 161, 182, 183, 68 Stat. 

935, 948, 953, 954, as amended (42 U.S.C. 

2111, 2201, 2232, 2233); sec. 201, 88 Stat. 

1242, as amended (42 U.S.C. 5841); sec. 1704, 

112 Stat. 2750 (44 U.S.C. 3504 note); sec. 

651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 

U.S.C. 2014, 2021, 2021b, 2111). 

■ 2. In § 35.50, paragraph (a)(2)(ii)(B) is 

revised to read as follows: 

§ 35.50 Training for Radiation Safety 

Officer. 

* * * * * 

(a) * * * 

(2) * * * 

(ii) * * * 

(B) In clinical nuclear medicine 

facilities providing diagnostic and/or 

therapeutic services under the direction 

of physicians who meet the 

requirements for authorized users in 

§§ 35.57, 35.290, or 35.390; 

* * * * * 

■ 3. In § 35.51, paragraphs (a)(2)(ii) and 

(b)(2) are revised to read as follows: 

§ 35.51 Training for an authorized medical 

physicist. 

* * * * * 

(a) * * * 

(2) * * * 

(ii) In clinical radiation facilities 

providing high-energy, external beam 

therapy (photons and electrons with 

energies greater than or equal to 1 


hsrobinson on PROD1PC76 with RULES
Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Rules and Regulations 33905 

million electron volts) and 

brachytherapy services under the 

direction of physicians who meet the 

requirements in § 35.57, 35.490, or 

35.690; and 

* * * * * 

(b) * * * 

(2) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraphs (c) and (a)(1) and (a)(2), or 

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

achieved a level of competency 

sufficient to function independently 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; and 

* * * * * 

■ 4. In § 35.57, a new paragraph (c) is 

added 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. 

* * * * * 

(c) Individuals who need not comply 

with training requirements as described 

in this section may serve as preceptors 

for, and supervisors of, applicants 

seeking authorization on NRC licenses 

for the same uses for which these 

individuals are authorized. 

■ 5. In § 35.190, the introductory text of 

paragraph (c)(1)(ii) and paragraph (c)(2) 

are revised to read as follows: 

§ 35.190 Training for uptake, dilution, and 

excretion studies. 

* * * * * 

(c)(1) * * * 

(ii) Work experience, under the 

supervision of an authorized user who 

meets the requirements in §§ 35.57, 

35.190, 35.290, 35.390, or equivalent 

Agreement State requirements, 

involving— 

* * * * * 

(2) Has obtained written attestation, 

signed by a preceptor authorized user 

who meets the requirements in §§ 35.57, 

35.190, 35.290, or 35.390, or equivalent 

Agreement State requirements, that the 

individual has satisfactorily completed 

the requirements in paragraph (a)(1) or 

(c)(1) of this section and has achieved a 

level of competency sufficient to 

function independently as an 

authorized user for the medical uses 

authorized under § 35.100. 

■ 6. In § 35.290, the introductory text of 

paragraph (c)(1)(ii) and paragraph (c)(2) 

are revised to read as follows: 

§ 35.290 Training for imaging and 

localization studies. 

* * * * * 

(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, involving— 

* * * * * 

(2) Has obtained written attestation, 

signed by 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, that the individual has 

satisfactorily completed the 

requirements in paragraph (a)(1) or 

(c)(1) of this section and has achieved a 

level of competency sufficient to 

function independently as an 

authorized user for the medical uses 

authorized under §§ 35.100 and 35.200. 

■ 7. In § 35.390, the introductory text of 

paragraph (b)(1)(ii) and paragraph (b)(2) 

are revised to read as follows: 

§ 35.390 Training for use of unsealed 

byproduct material for which a written 

directive is required. 

* * * * * 

(b)(1) * * * 

(ii) Work experience, under the 

supervision of an authorized user who 

meets the requirements in §§ 35.57, 

35.390, or equivalent Agreement State 

requirements. A supervising authorized 

user, who meets the requirements in 

§ 35.390(b), must also have experience 

in administering dosages in the same 

dosage category or categories (i.e., 

§ 35.390(b)(1)(ii)(G)) as the individual 

requesting authorized user status. The 

work experience must involve— 

* * * * * 

(2) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraphs (a)(1) and (b)(1)(ii)(G) or 

(b)(1) of this section, and has achieved 

a level of competency sufficient to 

function independently as an 

authorized user for the medical uses 

authorized under § 35.300. The written 

attestation must be signed by a 

preceptor authorized user who meets 

the requirements in §§ 35.57, 35.390, or 

equivalent Agreement State 

requirements. The preceptor authorized 

user, who meets the requirements in 

§ 35.390(b) must have experience in 

administering dosages in the same 

dosage category or categories (i.e., 

§ 35.390(b)(1)(ii)(G)) as the individual 

requesting authorized user status. 

■ 8. In § 35.392, the introductory text of 

paragraph (c)(2) and paragraph (c)(3) are 

revised 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). 

* * * * * 

(c) * * * 

(2) Has work experience, under the 

supervision of an authorized user who 

meets the requirements in §§ 35.57, 

35.390, 35.392, 35.394, or equivalent 

Agreement State requirements. A 

supervising authorized user who meets 

the requirements in § 35.390(b) must 

also have experience in administering 

dosages as specified in 

§§ 35.390(b)(1)(ii)(G)(1) or 

35.390(b)(1)(ii)(G)(2). The work 

experience must involve— 

* * * * * 

(3) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

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

section, and has achieved a level of 

competency sufficient to function 

independently as an authorized user for 

medical uses authorized under § 35.300. 

The written attestation must be signed 

by a preceptor authorized user who 

meets the requirements in §§ 35.57, 

35.390, 35.392, 35.394, or equivalent 

Agreement State requirements. A 

preceptor authorized user, who meets 

the requirement in § 35.390(b), must 

also have experience in administering 

dosages as specified in 

§§ 35.390(b)(1)(ii)(G)(1) or 

35.390(b)(1)(ii)(G)(2). 

■ 9. In § 35.394, the introductory text of 

paragraph (c)(2) and paragraph (c)(3) are 

revised 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). 

* * * * * 

(c) * * * 

(2) Has work experience, under the 

supervision of an authorized user who 

meets the requirements in §§ 35.57, 

35.390, 35.394, or equivalent Agreement 

State requirements. A supervising 

authorized user, who meets the 

requirements in § 35.390(b), must also 

have experience in administering 

dosages as specified in 

§ 35.390(b)(1)(ii)(G)(2). The work 

experience must involve— 

* * * * * 


hsrobinson on PROD1PC76 with RULES
33906 Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Rules and Regulations 

(3) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

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

section, and has achieved a level of 

competency sufficient to function 

independently as an authorized user for 

medical uses authorized under § 35.300. 

The written attestation must be signed 

by a preceptor authorized user who 

meets the requirements in §§ 35.57, 

35.390, 35.394, or equivalent Agreement 

State requirements. A preceptor 

authorized user, who meets the 

requirements in § 35.390(b), must also 

have experience in administering 

dosages as specified in 

§ 35.390(b)(1)(ii)(G)(2). 

■ 10. In § 35.396, the introductory text 

of paragraph (d)(2) and paragraph (d)(3) 

are revised to read as follows: 

§ 35.396 Training for the parenteral 

administration of unsealed byproduct 

material requiring a written directive. 

* * * * * 

(d) * * * 

(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 

administration, for which a written 

directive is required, of any beta emitter, 

or any photon-emitting radionuclide 

with a photon energy less than 150 keV, 

and/or parenteral administration of any 

other radionuclide for which a written 

directive is required. A supervising 

authorized user who meets the 

requirements in § 35.390 must have 

experience in administering dosages as 

specified in §§ 35.390(b)(1)(ii)(G)(3) 

and/or 35.390(b)(1)(ii)(G)(4). The work 

experience must involve— 

* * * * * 

(3) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraph (b) or (c) of this section, and 

has achieved a level of competency 

sufficient to function independently as 

an authorized user for the parenteral 

administration of unsealed byproduct 

material requiring a written directive. 

The written attestation must be signed 

by 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, must have 

experience in administering dosages as 

specified in §§ 35.390(b)(1)(ii)(G)(3) 

and/or 35.390(b)(1)(ii)(G)(4). 

■ 11. In § 35.490, the introductory text 

of paragraph (b)(1)(ii) and paragraphs 

(b)(2) and (b)(3) are revised to read as 

follows: 

§ 35.490 Training for use of manual 

brachytherapy sources. 

* * * * * 

(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 institution, involving— 

* * * * * 

(2) Has completed 3 years of 

supervised clinical experience in 

radiation oncology, under an authorized 

user who meets the requirements in 

§§ 35.57, 35.490, or equivalent 

Agreement State requirements, as part of 

a formal training program approved by 

the Residency Review Committee for 

Radiation Oncology of the Accreditation 

Council for Graduate Medical Education 

or the Royal College of Physicians and 

Surgeons of Canada or the Committee 

on Postdoctoral Training of the 

American Osteopathic Association. This 

experience may be obtained 

concurrently with the supervised work 

experience required by paragraph 

(b)(1)(ii) of this section; and 

(3) Has obtained written attestation, 

signed by a preceptor authorized user 

who meets the requirements in §§ 35.57, 

35.490, or equivalent Agreement State 

requirements, that the individual has 

satisfactorily completed the 

requirements in paragraph (a)(1), or 

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

section and has achieved a level of 

competency sufficient to function 

independently as an authorized user of 

manual brachytherapy sources for the 

medical uses authorized under § 35.400. 

■ 12. In § 35.491, paragraph (b)(3) is 

revised to read as follows: 

§ 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 paragraph (b) of this 

section and has achieved a level of 

competency sufficient to function 

independently as an authorized user of 

strontium-90 for ophthalmic use. 

■ 13. In § 35.690, the introductory text 

of paragraph (b)(1)(ii) and paragraphs 

(b)(2) and (b)(3) are revised to read as 

follows: 

§ 35.690 Training for use of remote 

afterloader units, teletherapy units, and 

gamma stereotactic radiosurgery units. 

* * * * * 

(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 institution, involving— 

* * * * * 

(2) Has completed 3 years of 

supervised clinical experience in 

radiation therapy, under an authorized 

user who meets the requirements in 

§§ 35.57, 35.690, or equivalent 

Agreement State requirements, as part of 

a formal training program approved by 

the Residency Review Committee for 

Radiation Oncology of the Accreditation 

Council for Graduate Medical Education 

or the Royal College of Physicians and 

Surgeons of Canada or the Committee 

on Postdoctoral Training of the 

American Osteopathic Association. This 

experience may be obtained 

concurrently with the supervised work 

experience required by paragraph 

(b)(1)(ii) of this section; and 

(3) Has obtained written attestation 

that the individual has satisfactorily 

completed the requirements in 

paragraph (a)(1) or paragraphs (b)(1) and 

(b)(2), and paragraph (c), of this section, 

and has achieved a level of competency 

sufficient to function independently as 

an authorized user of each type of 

therapeutic medical unit for which the 

individual is requesting authorized user 

status. The written attestation must be 

signed by a preceptor authorized user 

who meets the requirements in §§ 35.57, 

35.690, or equivalent Agreement State 

requirements for an authorized user for 

each type of therapeutic medical unit 

for which the individual is requesting 

authorized user status; and 

* * * * * 

Dated at Rockville, Maryland, this 26th day 

of June 2009. 

For the Nuclear Regulatory Commission. 

R.W. Borchardt, 

Executive Director for Operations. 

[FR Doc. E9–16658 Filed 7–13–09; 8:45 am] 

BILLING CODE 7590–01–P 


hsrobinson on PROD1PC76 with RULES