RULEMAKING ISSUE

NOTATION VOTE

October 30, 2002 SECY-02-0194

FOR: The Commissioners

FROM: William D. Travers

Executive Director for Operations

SUBJECT: OPTIONS FOR ADDRESSING PART 35 TRAINING AND EXPERIENCE

ISSUES ASSOCIATED WITH RECOGNITION OF SPECIALTY BOARDS

BY NRC

PURPOSE:

To present options for Commission consideration in resolving issues associated with the

training and experience (T&E) requirements in the recently published final rule amending 

10 CFR Part 35, as they apply to the recognition of specialty boards by NRC.

SUMMARY:

On April 12, 2002, the Commission issued a Staff Requirements Memorandum (SRM), in

response to COMSECY-02-0014, that approved a final rule regarding “Medical Use of

Byproduct Material.” The final rule was published in the Federal Register on April 24, 2002 

(67 FR 20250) and will become effective on October 24, 2002. In a supplemental SRM issued

on April 16, 2002, the Commission directed the staff to “develop a SECY paper that discusses

various options for addressing the T&E issue before the revised final rule becomes effective.” 

This Commission paper presents three options for Commission consideration. Option 1 is to 

retain the existing requirements in the final rule. Option 2 is to prepare a proposed rule to

modify T&E requirements based on the recommendations submitted by the Advisory

Committee on the Medical Uses of Isotopes (ACMUI). Option 3 is the same as Option 2 with a

CONTACT: Anthony Tse, NMSS/IMNS

(301) 415-6233
The Commissioners 2

minor modification (i.e., listing all specialty boards recognized by NRC on the website rather

than, as recommended by ACMUI, listing some boards in the regulation and others on the

website). The staff recommends that the Commission adopt Option 3.

BACKGROUND:

The issue in question concerns the new requirements in the final rule governing the recognition

of specialty boards (boards) by NRC. These requirements are in the final rule at 10 CFR 35.50,

35.51, 35.55, 35.190, 35.290, 35.390, 35.392, 35.394, 35.490, 35.590, and 35.690. The boards

represent one of two alternative pathways for certifying authorized individuals (e.g., radiation

safety officers (RSOs), authorized medical physicists (AMPs), authorized nuclear pharmacists

(ANPs), and authorized users (AUs)). The other alternative is through evaluation of individual

training and experience (T&E process). 

During development of the Part 35 proposed and final rules, there was a general belief that the

boards currently recognized by NRC would meet, or could make adjustments to meet, the new

requirements and that they would continue to be recognized by NRC. However, when

applications for recognition were received, the staff determined that, except for one board, the

boards did not meet all the requirements specified in the final rule. Specifically, the boards’

certification programs failed to meet the requirements in the final rule regarding preceptor

certification and work experience. The only board that currently meets the revised 

requirements is the Certification Board of Nuclear Cardiology, because it developed its

certification program based on the final rule. On various occasions, the staff discussed with the

boards as to whether the boards would modify their certifying programs to meet all the

requirements specified in the rule. No board indicated that they plan to change their process.

On February 19, 2002, ACMUI briefed the Commission and expressed a concern that if the

draft final rule became effective 6 months after the publication date, there could be potential

shortages of authorized individuals. Without changes in the draft final rule, the ACMUI was

concerned that the boards would no longer be qualified for recognition by NRC. Thus, a

board’s future diplomats could no longer be granted authorized individual status by NRC or an

Agreement State based on their board certification. The ACMUI argued that this might result in

a shortage of authorized individuals. 

Furthermore, the ACMUI expressed the concern that the boards may become “marginalized.” 

Under the final rule, the pathway to gain authorized status through the board process would

include all the requirements in the T&E process, which would require a specified length of

training and a written certification signed by a preceptor. Because there are extra requirements

for the board certification process, such as board written/oral examinations, potential

candidates seeking authorized status may bypass the board certification pathway and select

the simpler T&E process.

Based on these concerns, ACMUI urged the Commission to implement temporary measures to

address the T&E issue in the draft final rule and to find a permanent solution after publication of

the final rule. Subsequently, the staff changed the final rule by reinserting Subpart J (as

contained in the proposed rule) for a 2-year transition period.
The Commissioners 3

DISCUSSION:

There are three main reasons why the boards listed in Subpart J would no longer be qualified

for recognition under the final rule.

1. T&E Requirements

Under the current Part 35, boards are not required to meet specific didactic/laboratory training

and experience requirements to attain NRC recognition. Before a board was listed in 

Subpart J, ACMUI reviewed its certification program and determined the adequacy of the

program. The T&E provisions of the final rule, however, specifically mandate that an individual

must be certified by a medical specialty board whose certification process requires an individual

to meet all the applicable requirements listed in Part 35 for the alternative pathway of the T&E

process. This resulted in situations where the requirements of the board do not match the

specific criteria of the final rule. A comparison between NRC’s didactic/laboratory and

experience requirements in the final rule and boards’ requirements is presented in

Attachment 1.

2. Preceptor Certification

Under the current rule, preceptor certification is not required for board certification. The final

rule requires preceptor certification including a signature by an authorized individual. This

requirement applies to both board certification and the T&E process. Attachment 1 provides a

comparison between NRC’s preceptor certification in the final rule and boards’ certification or

reference requirements. Some boards require certification by a qualified individual, such as the

program director. However, this qualified individual need not necessarily be an authorized

individual, as required of a preceptor by the final rule. 

During the board certification process, the board makes its judgment that a candidate has

satisfactorily completed the board’s program and that the individual will be able to carry out the

duties of this certification. The questions that could be raised are: (1) whether another

qualified individual (e.g., a program director, a department head, or a professor) could also sign

the certification; and (2) in the case of the board certification process, whether the members of

the board could collectively act as a “preceptor.”

3. New Modalities

The T&E requirements in the final rule were expanded to address two new modalities that were

not considered in the current rule (i.e., remote after loader units and gamma stereotactic

radiosurgery units, as described in 10 CFR 35.690). These requirements were geared to

address unique health and safety issues raised by these modalities. However, the boards’

programs do not specifically include T&E for the new modalities. This raises a concern as to

how existing qualified individuals will obtain and demonstrate competence in radiation safety in

a new modality. 

The problem associated with the T&E requirements for new modalities can be illustrated as

follows. If a medical institution has only a teletherapy unit and its AMP is authorized for

teletherapy only, and the institution plans to add a High Dose Rate Remote After loader unit

(HDR), the questions that could be raised are: (1) what are the T&E requirements for the AMP
The Commissioners 4

to gain authorized status for HDR; (2) does the AMP need to go to another medical institution

for additional training; (3) what is the length of training; (4) how many cases should the AMP

perform independently; and (5) could the AMP receive the training for HDR in a manufacturer’s

facility or in a university setting, instead of another medical institution. 

ACMUI AND OTHER STAKEHOLDERS’ INPUT:

ACMUI formed a Subcommittee to develop recommendations on the T&E issue. A public

Subcommittee meeting was held on June 21, 2002, at NRC. Representatives from more than

13 boards, associations, or societies participated in the meeting. In addition, more than 8

boards or societies provided written comments to ACMUI Subcommittee on its

recommendations. After considering the comments from the meeting and letters, the

Subcommittee developed a final recommendation and submitted it to the full committee for

consideration. The staff noted that these interactions were substantive and that ACMUI

appeared to be responsive to stakeholder concerns while still maintaining a clear focus on the

desired radiation safety outcomes associated with adequate board certification criteria.

The ACMUI full Committee discussed the Subcommittee’s recommendation via a public

teleconference meeting on July 8, 2002. Members of the public and representatives from the

Society of Nuclear Medicine participated in the conference call meeting. The ACMUI’s report

was submitted to NRC on August 1, 2002 (Attachment 2). The Subcommittee’s

recommendations and the ACMUI report were posted on the NRC website. Discussions at the

public meetings primarily focused on the draft regulatory language contained in the

Subcommittee recommendations.

ACMUI RECOMMENDATIONS:

The ACMUI indicates that the reasons why the boards recognized in Subpart J would no longer

be qualified for recognition under the final rule are that the T&E provisions of the final rule: (1)

require that a board’s certification process include all of the T&E requirements in the alternative

pathway; (2) require that the preceptor be an authorized individual who meets the requirements

of the final rule, and (3) include new modalities not considered in the current rule. 

The ACMUI states that, for completeness, its recommendations are written to resemble rule

language. However, the ACMUI states that it is not the intention of the Committee to specify

rule language. 

As detailed in the ACMUI correspondence (Attachment 2), these recommendations are based

on the following assumptions:

(1) Currently accepted boards should be listed explicitly in the regulations,

(2) To facilitate addition of future certification mechanisms to the T&E qualification process

without rulemaking initiatives, criteria should be included in the rule to provide a basis for

recognizing new boards,

(3) It is expected that the currently accepted boards will meet the criteria in (2),
The Commissioners 5

(4) The preceptor concept should be modified to become documentation for completion of a

training program rather than a testament to clinical competence, and

(5) Specific training should be required for certain new devices or modalities. This training is

considered to be a separate requirement that is decoupled from the core training and

supervised experience.

OPTIONS:

Option 1 No change in the final rule. Continue to require a board to meet the T&E

requirements specified in the final rule, including didactic/laboratory training,

work experience, and preceptor certification. 

Option 2 Adoption of ACMUI recommendations. Prepare a proposed rule to modify the

T&E requirements based on ACMUI recommendations and using the ACMUI

suggested rule language as a starting point for the proposed rule and supporting

regulatory analysis.

Option 3 Same as option 2 (i.e., adoption of ACMUI recommendations) except that all

current or new boards that meet the criteria for recognition by NRC will be listed

on the NRC website, not in the regulations. 

COMPARISON OF OPTIONS:

Option 1, which affirms the requirements of the final rule, would require the boards to modify

their certification programs as necessary to comply with the specified requirements. If the

boards chose not to change, they could not continue to certify authorized individuals after the

transition period ends. Candidates who desired to become authorized individuals would have to

be certified through the T&E process. The burden for allowing authorized individuals to work

would be increased because licensees would have to submit amendments and receive NRC

approval before individuals certified through the T&E process could serve as authorized

individuals. However, if boards chose not to modify their programs, the concerns for a potential

shortage of authorized individuals would remain.

Under Option 2, the NRC would initiate rulemaking to propose modifying the regulations to

specify separate T&E criteria for recognition of boards. The regulations would continue to

specify T&E requirements for individuals seeking authorized status, specify separate T&E

requirements for new modalities, and modify the preceptor certification to be signed by a

qualified individual. Under this option, the concerns regarding the radiation safety for new

modalities and the preceptor certification would be resolved. Option 2 is expected to increase

stakeholder confidence because of the avoidance of concerns over potential disruption of

medical services due to a shortage of authorized individuals. A disadvantage of this option is

that, if some boards are listed in the rule and others on the NRC website, a licensee would not

have a single location to verify qualified boards. In addition, if a board were to be deleted from

the rule listing, the staff would have to amend the listing through rulemaking.

Option 3 is the same as Option 2 with the exception that all current and new boards that meet

the criteria will be listed on the NRC website, not in regulations. Placing the currently approved

boards and newly approved boards on the website would eliminate an unnecessary division
The Commissioners 6

between the two groups of boards. Individuals would not be required to review two locations for

a listing of approved boards. Additional advantages include eliminating added burden on

licensees and increasing the efficiency and effectiveness of NRC resources.

Adoption of the ACMUI recommendations would eliminate the problems for recognizing the

boards without compromising radiation safety. In addition, listing all boards on the NRC

website rather than listing some boards in the regulation and others on the website is more

effective and efficient. The staff therefore recommends Option 3.

AGREEMENT STATES INPUT:

A draft of this Options Paper was forwarded to Agreement States for comment. Four comment

letters were received: one each from States of Alabama, Illinois, Iowa, and Washington

(Attachment 3). 

Alabama recommended that the NRC adopt Option 1, with certain caveats. Iowa and

Washington stated that the NRC appears to be proposing a lesser T&E standard for boardcertified authorized users as compared to non-certified authorized users. They suggested that

the certifying boards should be held to the same standards as the non-certified alternative (e.g.,

the certifying boards should be held to the same number of hours of T&E as specified in the

final rule, such as 700 hours for imaging and localization studies). Although the requirements

are not identical, the T&E standard for recognizing certifying boards would not be lesser than

the standard for the non-certified alternative. The board certification process requires a

candidate to have an academic degree, complete practical experience or a residency program,

and pass an examination. The examination tests the knowledge and skills required to perform

the activities responsible by the authorized users, including activities to ensure radiation safety. 

The staff considers that the combination of degree, practical experience, and examination in the

criteria for recognizing certifying boards would be equivalent to the number of hours of didactic

and experience specified for the non-certified alternative. 

Washington stated that the preceptor requirement should be modified as recommended by

ACMUI. However, Illinois suggested that NRC retain the preceptor certification in the final rule

(i.e., including certification of competency) for individuals seeking to achieve authorized status

through the alternative (i.e., non-board certification) pathway. For board certified individuals,

Illinois expects that the board certification process contains prerequisites, inherent milestones,

and internal certifications that are predictive of effective performance, and that therefore board

certified individuals typically will be competent in the duties required by a medical use licensee. 

Alabama agreed that the NRC should allow the boards to accept another individual to sign on

behalf of the actual preceptor, as long as the individual is the preceptor’s supervisor, such as a

department head or program director, and submits a list of the preceptors as reference. The

staff will solicit ACMUI’s input on whether the preceptor certification should be retained in the

T&E requirements for the alternative pathway in preparing a proposed rule.

In addition, Illinois suggested adding a training requirement as paragraph (d)(1)(iv) in Section

35.12, "Application for license, amendment, or renewal," for emerging technologies (35.1000). 

The staff believes it is not necessary to add such a training requirement. This issue was

considered during the development of the final rule. As explained in the Supplementary

Information to the final rule, Section 35.1000 does not include any T&E requirements because

there is no way of knowing what training requirements will be necessary for the safe use of
The Commissioners 7

byproduct material in new technologies. Applicants are required by 35.12(b) to provide

information as to the T&E for the AU, ANP, or AMP as appropriate to the NRC, which will be

evaluated on a case-by-case basis. See 67 FR 203321 (April 24, 2002). 

Illinois further stated that the ACMUI should assume an active role in establishing specific

training and experience criteria when future technologies are identified. After the criteria are

established, the NRC should promptly post these criteria on the website. This would make

them quickly available to the regulated community and the Agreement States. The staff is

generally supportive of the recommendation, and it is consistent with our implementation plans

for the new rule. 

Both Illinois and Washington stated that they support ACMUI recommendations (except as

stated above) and NRC's plan to list boards on the website, not in regulations.

AGREEMENT STATE COMPATIBILITY:

For Agreement States, adopting the new T&E requirements by October 24, 2005, would result

in shortening the time frame to develop compatible T&E requirements. During the Organization

of Agreement States (OAS) meeting in October 2002, the Agreement States voiced their

concern regarding the adoption of compatible T&E requirements by October 24, 2005. The

staff indicated at the meeting that it would provide States additional time after the OAS meeting,

to submit any additional concerns regarding the timeline for adoption of the new rule. However,

to date the staff has not received any additional comments. Therefore, the staff intends to

proceed with a proposed rule and will specifically solicit comments from all stakeholders on the

issue of the timing of the adoption of compatible T&E requirements by Agreement States.

COORDINATION:

The Office of the General Counsel has no legal objection to the use of any of the options

presented in this paper. The Office of the Chief Financial Officer has reviewed this Commission

Paper for resource implications and has no objections. 

RESOURCES:

If the Commission adopts Option 3 associated with rulemaking, an initial estimate would be 

0.5 FTE for the proposed rule and 0.4 FTE for the final rule. These resources are currently

identified within the NMSS budget for rulemaking activities. No contractual support is

anticipated. 

SCHEDULE:

If the Commission accepts the staff recommendation, the staff endorses proceeding directly to

develop a proposed rule without generating an additional rulemaking plan. Immediately

developing a proposed rule will allow staff to meet the Commission’s directive in the SRM dated

April 16, 2002. The staff would work closely with the ACMUI and Agreement States for

developing the proposed rule. In accordance with the Commission’s Policy Statement on

Adequacy and Compatibility of Agreement State Programs, the Agreement States have three

years from the effective date of the Part 35 final rule to develop compatible requirements 

(i.e., no later than October 24, 2005). 
The Commissioners 8

It is expected that the proposed rule would be submitted to the Commission for approval

approximately 6 months after Commission decision and direction through an SRM on a

rulemaking, allowing time for Agreement State interaction. The final rule is expected to be

submitted to the Commission for approval approximately 6 months after the closing of the

public comment period for the proposed rule. This schedule will allow the revision to be

effective before the end of the 2-year transaction period for Subpart J on October 24, 2004. 

RECOMMENDATION:

That the Commission adopt Option 3 and direct the staff to proceed with a proposed

rulemaking.

/RA/

William D. Travers

Executive Director 

 for Operations

Attachments:

1. Comparison Between NRC Requirements and Boards Certification Programs

2. ACMUI Recommendations

3. Agreement State Comment Letters 
The Commissioners 8

It is expected that the proposed rule would be submitted to the Commission for approval

approximately 6 months after Commission decision and direction through an SRM on a

rulemaking, allowing time for Agreement State interaction. The final rule is expected to be

submitted to the Commission for approval approximately 6 months after the closing of the

public comment period for the proposed rule. This schedule will allow the revision to be

effective before the end of the 2-year transaction period for Subpart J on October 24, 2004. 

RECOMMENDATION:

That the Commission adopt Option 3 and direct the staff to proceed with a proposed

rulemaking.

/RA/

William D. Travers

Executive Director

 for Operations

Attachments:

1. Comparison Between NRC Requirements and Boards Certification Programs

2. ACMUI Recommendations

3. Agreement State Comment Letters

(g:\tse\Part35.OptionsPaper.wpd) ML022700166 * See previous concurrence

OFFICE: RGB:IMNS RGB:MSIB RGB:IMNS D:IMNS

NAME: TTse* TEssig* CHolden* Dcool*

DATE: 9/ 19 /2002 9/ 20/2002 9/ 19/2002 9/ 20/2002

OFFICE: Tech Editor OGC nlo D:OE OSTP

NAME: EKraus* STreby FCongel* PLohaus*

DATE: 7/ 15/2002 9/ 26/2002 8/ 12/2002 8/ 19/2002

OFFICE: CFO ADM CIO D:NMSS

NAME: JFunches* MLesar* BShelton* MVF for MVirgilio

DATE: 8/ 22 / 2002 8/ 5 /2002 8/ 27/2002 10/14 /2002

OFFICE: DEDMRS EDO

NAME: CPaperiello WTravers

DATE: 10/25/02 10/30/02

OFFICIAL RECORD COPY
ATTACHMENT 1

COMPARISON BETWEEN NRC REQUIREMENTS 

AND

BOARDS CERTIFICATION PROGRAMS

This Attachment contains tables showing comparisons between NRC’s T&E requirements, as

specified in the final rule, and the boards’ certification programs. 

The comparisons include the following authorized individuals:

Table 1 Radiation safety officer (§ 35.50)

Table 2 Authorized medical physicist (§ 35.51)

Table 3 Authorized nuclear pharmacist (§ 35.55)

Table 4 Authorized user in uptake, dilution, and excretion studies (§ 35.190)

Table 5 Authorized user in imaging and localization (§ 35.290)

Table 6 Authorized user in unsealed byproduct material requiring written directive 

(§ 35.390)

Table 7 Authorized user in manual brachytherapy sources (§ 35.490)

Table 8 Authorized user in remote after loader units, teletherapy units, and gamma

stereotactic radiosurgery units (§ 35.690)
Table 1 - Certification Requirements for 

Radiation Safety Officer (RSO) (35.50)

Final rule Certification Through T&E Process Certification

Through Board

(A) Didactic training (B) Experience (C) Certification Process

35.50(b)(1)(i)

200 hours in:

1. Rad phy/instrument

2. Rad protection

3. Math for use/meas

of radioactivity

4. Rad biology

5. Rad dosimetry

35.50(b)(1)(ii)

One year supervised

radiation safety experience in

similar uses in:

1. Shipping/receiving & rad

surveys

2. Performing checks on

instruments

3.Securing/controlling

byproduct material

4. Using controls to avoid

mistakes in administration of

byproduct material 

5. Using procedures to

prevent contamina & proper

decontam

6. Using emergency

procedures to control

byproduct material

7.Disposing byproduct

material

35.50(b)(2)

Signed by a preceptor

RSO that the individual

satisfies

 (A) + (B) + can

function independently 

35.50 (a)

(A) + (B) + (C) +

Additional Board

Requirements

(e.g.

examination)

Example of

Boards Listed in

Subpart J

Training/Education Experience Certification/

References

Additional Board

Requirements 

Am B of Health

Physics In

Comprehensive

Health Physics

BS deg in physical

science, engineering,

or biological science

with minor in physical

science or eng.

6 yrs prof exp - at

least 3 yrs in applied

heath physics (MS,

subst 1 yr exp; PhD

subst 2 yrs)

Certification: Board

Chairperson certifies

met prof standards of

the board

References: The

individual’s supervisor;

2 other professionally

qualified to evaluate

candidates ability in

HP(at least 1 certified)

Written Exam: 

Part I- fundamental HP;

Part II- applied HP;

covering 5 domains:

measurements,

regulation/standards,

facilities/equipment,

operation/procedure,

education/training
Table 2 - Certification Requirements for 

Authorized Medical Physicist (AMP) (35.51)

Final rule Certification Through T&E Process Certification

Through

Board

Process (A) Training & Experience (B) Certification

35.51(b)(1)

1. Master/doctoral deg in physics, biophysics, radiological

physics, or medical physics

2. One year training in therapeutic radiological physics

3. Additional year work experience under an AMP at medical

institution, including the following specific tasks, as applicable:

a. 35.67 Reqs for sealed sources & brachytherapy sources

b. 35.433 Decay of Sr-90 sources

c. 35.632 Full calibration measurements on teletherapy units

d. 35.633 Full calibration meas on remote after loader units

e. 35.635 Full calibration meas on gamma radiosurgery units

f. 35.642 Periodic spot-check for teletherapy units

g. 35.643 Periodic spot-check for remote after loader units

h. 35.645 Periodic spot-check for gamma radiosurgery units

i. 35.652 Radiation surveys

35.51(b)(2)

Signed by a

preceptor AMP

who meets 35.51

that the individual

satisfies (A) + can

function

independently for

each type of

therapeutic

medical unit 

35.51(a)

(A) + (B) +

Additional

Board

Requirements

(e.g.

examination)

Examples of

Boards Listed

in Subpart J:

Training/

Education

Experience Certification/

References

Additional Board

Requirements

A. Am B of

Radiology in:

1.Therapeutic

radiology

physics

2. Roentgen

ray and

gamma ray

physics

3. X-ray and

Radium

physics 

4. Radiology

physics

1.Bachelor deg in

phy, eng, etc. and

2.Master/doc deg in

med phy, phy, eng,

etc. and

3.Formal course

work in biological

sciences

3 yrs exp with

clinical department

(MS subst 6 month,

PhD subst 12

month) under

supervision of cert

physicist or

radiologic physician

One certif physician & one

certif physicist in the same

specialty 

Physicist must directed

the special training

References must have

personal knowledge of the

applicant

1. Written exam:

Part 1 includes

measurements, radiation

protection, clinical aspects of

radiological physics

Part 2 includes 3 subparts:

Therapeutic phy; diagnostic

phy, and medical nuclear phy

(radioactive sources,

calibration, rad protection).

2. Oral exam:

5 parts, including

radiation safety & patient

safety, patient related

measurement, equipment, etc.

B. Am B of

Medical

Physics in

radiation

oncology

physics

Graduate deg in

physics, med phy,

or other related field

1. Clinical residency

training from an

accredited program

or

2. MS-6 yrs, 

MS (med phy)-4 y

MS(med phy,

accredited)-3 y

PhD-4 y

PhD (med phy)-3 y

PhD (m.p. accr)-2 y

2 Ltrs of endorsement to

verify work experience

and professional

qualifications-must be

from a certified medical

physicist and a certified

physician who practice in

the medical specialty and

who has personal

Knowledge

1. Written exam:

Part I: Fundamental medical

physics, including radiation

protection, radiation

measurements

Part II: For specialty areas in:

medical health physics,

radiation oncology phy, etc.

2. Oral exam: include rad

safety/hazards
Table 3 - Certification Requirements for 

Authorized Nuclear Pharmacist (ANP) (35.55)

Final rule Certification Through T&E Process Certification

Through Board

(A) 700 hrs structured educational program (B) Certification Process

35.55(b)(1)(i)

Didactic training in:

1. Rad phy/instrument

2. Rad protection

3. Math for use/meas

of radioactivity

4. Chemistry of

byproduct material for

med use

5. Rad biology

35.55(b)(1)(ii)

Supervised practical experience

in a nuclear pharmacy in:

1. Shipping/receiving & rad

surveys

2. Performing checks on

instruments

3. Calc, assay, & safely

preparing dosages

4. Using controls to avoid

mistakes in administration of

byproduct material

5. Using procedures to prevent

contamina & proper decontam

35.55(b)(2)

Signed by a

preceptor ANP that

the individual satisf

 (A) + can function

independently 

35.55 (a)

(A) + (B) +

Additional Board

Requirements

(e.g.

examination)

Example of

Boards Listed in

Subpart J

Training/

Education

Experience Certification/

References

Additional Board

Requirements 

Board of

Pharmaceutical

Specialties as a

nuclear

pharmacist

1. Graduation from a

pharmacy program

accredited by Am

Council on

pharmaceutical

Education

2. Must have current

license to practice

pharmacy

4000 hours

experience (MS or

PhD in nuclear

pharmacy subst

2000hrs.)

None Written exam in 9

domains, including

health and safety

domain
Table 4 - Certification Requirements for

Authorized User in Uptake, Dilution, and Excretion Studies (35.190)

Final rule Certification Through T&E Process Certification

Through Board

(A) 60 hrs of Training and Experience (B) Certification Process

35.190(c)(1)(i)

Classroom and

laboratory training in:

1. Radiation

phy/instrument

2. Rad protection

3. Math for use/meas

of radioactivity

4. Chemistry of

byproduct material

for med use

5. Rad biology

35.190(c)(1)(ii)

Work experience under AU (who

meets 35.190, 290, or 390) in:

1. Ordering/receiving, unpacking,

rad surveys

2. Calibrate dose instrument &

performing checks on survey meter

3. Calc, measuring, & safely

preparing dosages

4. Using controls to prevent

medical events involving unsealed

byproduct material

5. Using procedures to contain

spills & proper decontam

6. Administering dosages 

35.190(c)(2)

Signed by a

preceptor AU (who

meets 35.190, 290,

or 390) that the

candidate satisfies

(A) + can function

independently 

35.190(a)

(A) + (B) +

Additional Board

Requirements

(e.g.

examination)

Example of

Boards Listed in

Subpart J

Training/

Education

Experience Certification Additional Board

Requirements 

Am B of Nuclear

Medicine in

nuclear medicine 

1.Graduation from a

medical school

approved by the

Liaison Committee

on Medical

Education

2. Valid license to

practice of medicine

1. One or more yrs of

preparatory post-doc

training and

2. Two-yr formal

residency training

Requires residency

program directors to

certify the applicant is

competent in clinical

nuclear medicine. 

Written exam
Table 5 - Certification Requirements

Authorized User in Imaging and Localization Studies (35.290)

Final rule Certification Through T&E Process Certification

Through

Board

Process (A) 700 hrs of Training and Experience (B) Certification

35.290(c)(1)(i)

Classroom and

laboratory training

in:

1. Radiation

phy/instrument

2. Rad protection

3. Math for

use/meas of

radioactivity

4. Chemistry of

byproduct material

for med use

5. Rad biology

35.290(c)(1)(ii)

Supervised work under AU (who

meets 35.290 or 35.390) in:

1. Ordering/receiving, unpacking, rad

surveys

2. Calibrating dose instrument &

performing checks on survey meter

3. Calc, measuring, & safely preparing

dosages

4. Using controls to prevent medical

events involving unsealed byproduct

material

5. Using procedures to contain spills &

proper decontam

6. Administering dosages

7. Eluting generator systems &

preparing radioactive drugs

35.290(c)(2)

Signed by a

preceptor AU who

meets 35.290 or

35.390 that the

candidate

satisfies

 (A) + can function

independently 

35.290(a)

(A) + (B) +

Additional

Board

Requirements

(e.g.

examination)

Example of

Boards Listed in

Subpart J

Training/

Education

Experience Certification Additional Board

Requirements 

Am B of Nuclear

Medicine in

nuclear medicine

1.Graduation from a

medical school

approved by the

Liaison Committee

on Medical

Education

2. Valid license to

practice of medicine

1. One or more yrs of

preparatory post-doc

training and

2. Two-yr formal

residency training

Requires residency

program directors to

certify the applicant is

competent in clinical

nuclear medicine. 

Written exam
Table 6 - Certification Requirements

Authorized User in Unsealed Byproduct Material Req Written Directive (35.390) 

Final rule Certification Through T&E Process Certification

Through

Board

Process (A) 700 hrs of Training and Experience (B) Certification

35.390(b)(1)(i)

Classroom and

laboratory training

in:

1. Radiation

phy/instrument

2. Rad protection

3. Math for

use/meas of

radioactivity

4. Chemistry of

byproduct material

for med use

5. Rad biology

35.390(b)(1)(ii)

Supervised work under AU (who

meets 35.290 or 35.390) in:

1. Ordering/receiving, unpacking, rad

surveys

2. Calibrating dose instrument &

performing checks on survey meter

3. Calc, measuring, & safely preparing

dosages

4. Using controls to prevent medical

events involving unsealed byproduct

material

5. Using procedures to contain spills &

proper decontam

6. Eluting generator systems &

preparing radioactive drugs 

7. Administering dosages (at least 3

cases in each of 4 categories) 

35.390(b)(2)

Signed by a

preceptor AU who

meets 35.390(a)

or (b) and who

has experience in

same dose

categories that

the individual

satisfies

 (A) + can function

independently 

35.390(a)

(A) + (B) +

Additional

Board

Requirements

(e.g.

examination)

Example of

Boards Listed in

Subpart J

Training/

Education

Experience Certification Additional Board

Requirements 

Am B of Nuclear

Medicine 

1.Graduation from a

medical school

approved by the

Liaison Committee

on Medical

Education

2. Valid license to

practice of medicine

1. One or more yrs of

preparatory post-doc

training and

2. Two-yr formal

residency training

Requires residency

program directors to

certify the applicant is

competent in clinical

nuclear medicine. 

Written exam
Table 7 - Certification Requirements for

Authorized User in Manual Brachytherapy Sources (35.490)

Final rule Certification Through T&E Process Certification

Through

Board

Process (A) Didactic (B) Work

Experience

(C) Clinical

Experience

(D) Certification

35.490(b)(1)(i)

200 hours

Classroom and

laboratory training

in:

1. Radiation

phy/instrument

2. Rad protection

3. Math for use/meas

of radioactivity

4. Rad biology

35.490(b)(1)(ii)

500 hours work

experience under AU

(who meets 35.490)

in:

1. Ordering/receiving,

unpacking, rad surveys

2. Checking survey

meters

3. Preparing,

implanting, removing

sources 

4. Maintaining running

inventories

5. Using controls to

prevent medical events

involving byproduct

material

6 Using emergency

procedures to control

byproduct material

35.490(b)(2)

3 years

supervised

clinical

experience

under AU

(who meets

35.490)

35.490(b)(3)

Signed by a

preceptor AU

(who meets

35.490) that the

individual

satisfies (A) + (B)

+ (C) + can

function

independently

35.490(a)

(A) + (B) +

(C)+ (D) +

Additional

Board

Requirements

(e.g.

examination)

Example of

Boards Listed in

Subpart J

Training/

Education

Experience Certification Additional Board

Requirements 

Am B of Radiology 1. Graduation from

a medical school

2. Is a specialist in

Radiation Oncology

3. Have high moral

& ethical standards

in his/her profession

five yrs - 4 yr must be

in Radiation Oncology

A written statement

from current program

director of special

training attesting that

the applicant will have

satisfactorily completed

the required special

training & will have

achieved adequate

professional

qualifications for the

exam in radiation

oncology

1. Written exam

2. Oral exam
Table 8 - Certification Requirements for

Authorized User in Remote Aterloader Units, etc. (35.690)

Final rule Certification Through T&E Process Certification

Through

Board

Process (A) Didactic (B) Work

Experience

(C) Clinical

Experience

(D) Certification

35.690(b)(1)(i)

200 hours

Classroom and

laboratory training

in:

1. Radiation

phy/instrument

2. Rad protection

3. Math for

use/meas of

radioactivity

4. Rad biology

35.690(b)(1)(ii)

500 hours work

experience under AU

(who meets 35.690) in:

1. Reviewing full

calibration & spot check

2. Preparing treatment

plans & calc treatment

dose/time

3. Using adm controls to

prevent med events

4. Implementing

emergency procedures for

abnormal operation

5. Checking/using survey

instruments

6 Selecting proper dose &

how it is to be

administered

35.690(b)(2)

3 years

supervised

clinical

experience

under AU

(who meets

35.690)

35.690(b)(3)

Signed by a

preceptor AU

(who meets

35.690 for each

type relevant

therapeutic unit)

that the

individual

satisfies (A) + (B)

+ (C) + can

function

independently

35.490(a)

(A) + (B) +

(C)+ (D) +

Additional

Board

Requirements

(e.g.

examination)

Example of

Boards Listed in

Subpart J

Training/

Education

Experience Certification Additional Board

Requirements 

Am B of Radiology 1. Graduation

from a medical

school

2. Is a specialist in

Radiation

Oncology

3. Have high

moral & ethical

standards in

his/her profession

five yrs - 4 yr must

be in Radiation

Oncology

A written statement

from current program

director of special

training attesting that

the applicant will have

satisfactorily

completed the

required special

training & will have

achieved adequate

professional

qualifications for the

exam in radiation

oncology.

1. Written exam

2. Oral exam
1

ATTACHMENT 2

ACMUI RECOMMENDATIONS

August 1, 2002

RECOMMENDATIONS OF THE NRC ACMUI SUBCOMMITTEE ON TRAINING AND

EXPERIENCE REQUIREMENTS

INTRODUCTION

A revision of 10 CFR Part 35, Medical Use of Byproduct Material, was published on April 24,

2002 (Federal Register Vol. 67(79) 20371-20397). The revision contains new training and

experience requirements for individuals to become authorized as a radiation safety officer

(RSO), authorized medical physicist (AMP), authorized nuclear pharmacist (ANP), and

authorized user (AU). These new requirements provide several options for individuals to

become authorized. One option is for individuals to be certified by a specialty board whose

certification process includes all the requirements in an alternate pathway. The alternate

pathway includes specified numbers of hours of training and written certification signed by a

preceptor that the individual has satisfactorily completed the training requirements and has

achieved a level of competency sufficient to function independently as an RSO, AMP, ANP, or

AU. Currently, most specialty boards do not require candidates to meet these specific

requirements. 

The Advisory Committee on Medical Uses of Isotopes (ACMUI) appointed a subcommittee on

training and experience requirements to develop recommendations that would restore board

certification as the default pathway for individuals to become authorized as RSO, AMP, or AU. 

The subcommittee held a meeting on June 21 in Rockville, Maryland and a meeting on July 8

by conference call to discuss draft recommendations and to receive public input. The following

recommendations include consideration of discussion from these meetings.

For completeness these recommendations are written to resemble rule language. However, it

is not the intention of the subcommittee to specify rule language.

RATIONALE

These recommendations are based on the following assumptions:

(1) Currently accepted boards should be listed explicitly in the regulations;

(2) To facilitate addition of future certification mechanisms to the T&E qualification

process without rulemaking initiatives, criteria should be included in the rule to

provide a basis for recognizing new boards;

(3) It is expected that the currently accepted boards will meet the criteria in (2);

(4) The preceptor concept should be modified to become documentation for

completion of a training program rather than a testament to clinical competence;

and;

(5) Specific training should be required for certain new devices or modalities. This

training is considered to be a separate requirement that is decoupled from the

core training and supervised experience.

The intent of these recommendations is to provide minimum training and experience

requirements for an individual to become an AMP, ANP, AU, or RSO. The objective of these

requirements is to assure the safe use of byproduct material used in medical practice. 
2

Several pathways are provided to demonstrate adequate knowledge of the safe use of

byproduct material. For AMP, ANP, RSO, and most categories of use for AU, adequate

knowledge may be demonstrated by obtaining certification by a specialty board. The

subcommittee's examination of various specialty board criteria for admission of candidates

revealed that few specialty boards meet the specific requirements of revised Part 35 published

April 24, 2002. However, the subcommittee concluded that individuals who had completed the

certification process by appropriate specialty boards had demonstrated adequate knowledge in

the safe use of byproduct material for their specialty. Thus the subcommittee recommends that

these boards be specifically listed as approved boards. 

Additional specialty boards may be identified in the future. Therefore, the subcommittee

developed specific criteria for recognition of specialty boards. To the best of our knowledge,

those specialty boards that are listed in these recommendations meet these specific criteria. 

As an alternative to board certification, an individual may demonstrate completion of specified

training and experience requirements as provided in revised Part 35. 

In addition to meeting the minimum training and experience requirements, authorized

individuals would be expected to demonstrate training or experience in the use of byproduct

material or specific modalities, as appropriate, which are identified on the licensee's license. 

This would require a licensee to assure that newly hired authorized individuals have appropriate

training and experience and that current authorized individuals receive appropriate training

when a new modality is added to the licensee's program.

§ 35.50 Training for Radiation Safety Officer

Except as provided in § 35.57, the licensee shall require the an individual fulfilling the

responsibilities of the Radiation Safety Officer as provided in § 35.24 to be an individual who –

(a) Is certified by: 

(1) American Board of Health Physics in Comprehensive Health Physics;

(2) American Board of Medical Physics in Medical Health Physics; or

(3) American Board of Science in Nuclear Medicine in Radiation Protection;

or

(b) Is certified by a specialty board whose certification has been recognized by the

Commission and requires all diplomats:

(1) To hold a bachelors 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;

(2) To have five or more years of professional experience in health physics

(graduate training may be substituted for no more than two years of the

required experience) including at least three years in applied health

physics;

(3) To provide a written statement from the supervising physicist or Radiation

Safety Officer attesting that the individual has completed the training and

experience described in paragraph (b)(2) of this section; and

(4) To pass an examination administered by diplomats of the specialty board,

which evaluate knowledge and competence in radiation physics and

instrumentation, radiation protection, mathematics pertaining to the use

and measurement of radioactivity, and radiation biology; or

(c) (1) Has completed a structured educational program consisting of 200 hours

of didactic training in the following areas--

(i) Radiation physics and instrumentation;
3

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of

radioactivity;

(iv) Radiation biology; and

(2) Has one year of full-time radiation safety experience under the

supervision of an individual identified as the Radiation Safety Officer on a

Commission or Agreement State license that authorizes similar types(s)

of use(s) of byproduct material involving the following--

(i) Shipping, receiving, and performing related radiation surveys;

(ii) Using and performing checks for proper operation of instruments

used to determine the activity of dosages, survey meters, and

instruments used to measure radionuclides;

(iii) Securing and controlling byproduct material;

(iv) Using administrative controls to avoid mistakes in the

administration of byproduct materials;

(v) Using procedures to prevent or minimize radioactive

contamination and using proper decontamination procedures;

(vi) Using emergency procedures to control byproduct material; and

(vii) Disposing of byproduct material; and

(3) Has provided a written statement from the supervising physicist(s) or

Radiation Safety Officer(s) attesting that the individual has completed the

training and experience described in paragraph (c)(1) and (c)(2) of this

section; or

(d) Is an authorized user, authorized medical physicist, or authorized nuclear

pharmacist identified on the licensee's license and has experience with the

radiation safety aspects of similar types of use of byproduct material for which

the individual has Radiation Safety Officer responsibilities.

(e) In addition to meeting the requirements of (a), (b), (c), or (d) of this section, the

licensee shall require a Radiation Safety Officer to have training in the radiation

safety, regulatory issues, emergency procedures, and proposed clinical

procedures of any modality for which the licensee seeks authorization. This

training requirement may be satisfied by completing training that is supervised by

an Authorized Medical Physicist, Authorized User, or Radiation Safety Officer as

appropriate, who is authorized for the modality for which the licensee is seeking

authorization.

§ 35.51 Training for an Authorized Medical Physicist.

Except as provided in § 35.57, the licensee shall require the authorized medical physicist to be

an individual who –

(a) Is certified by the one of the following specialty boards in radiation oncology

physics (“radiation oncology physics” understood to be that branch of medical or

radiological physics that is applied to clinical practice of radiation oncology) 

(1) American Board of Radiology in therapeutic radiological physics;

(2) American Board of Radiology in roentgen ray and gamma ray physics;

(3) American Board of Radiology in x-ray and radium physics; 

(4) American Board of Radiology in radiological physics; or

(5) American Board of Medical Physics in radiation oncology physics; or 

(b) Is certified by a specialty board in radiation oncology physics whose certification

has been recognized by the Commission and requires all diplomats; 
4

(1) To hold a master's or doctor's degree in physics, medical physics, other

physical science, engineering, or applied mathematics from an institution

accredited by a regional accrediting body;

(2) To have two years of full-time practical training and/or supervised

experience in radiation oncology physics 

(i) Under the supervision of a medical physicist who is certified in

radiation oncology physics by the board in question, a board

specified in paragraph (a) of this section; or a specialty board

recognized by the Commission according to this paragraph (b) of

this section

 (ii) In a clinical radiation oncology facility providing megavoltage

external beam therapy and brachytherapy services under the

direction of physicians who meet the requirements for authorized

users in 35.400 or 35.600;

(3) To obtain a written statement from a medical physicist, certified by a

specialty board listed in paragraph (a) of this section or recognized by the

Commission according to paragraph (b) of this section and who has

personal knowledge of the candidate’s training and experience, attesting

that the individual has satisfactorily completed the training and

experience described in paragraph (b)(2) of this section; and

(4) To pass an examination administered by diplomats of the specialty board,

which assesses knowledge and competence in clinical radiation

oncology, radiation safety, calibration, quality assurance, and treatment

planning for external beam therapy, brachytherapy and stereotactic

radiosurgery; or

 (c) (1) Holds a master's or doctor's degree in physics, medical physics, other

physical science, engineering, or applied mathematics from an institution

accredited by a regional accrediting body;

(2) Has completed 1 year of full-time training in radiation oncology physics

and an additional year of full-time work experience under the supervision

of an individual who meets the requirements for an authorized medical

physicist for the modality in which the individual is seeking authorization

in a clinical radiation oncology facility that provides megavoltage external

beam therapy and brachytherapy services that include 

(i) performing sealed source leak tests and inventories; 

(ii) performing decay corrections; 

(iii) performing full calibration and periodic spot checks of external

beam treatment units, stereotactic radiosurgery units, and remote

afterloading units as applicable; and

(iv) conducting radiation surveys around external beam, remote

afterloading and stereotactic radiosurgery units as applicable; and

(3) Has obtained a written statement from the supervising medical physicist

attesting that the individual has satisfactorily completed the training and

experience described in paragraph (c)(2) of this section and identifies the

byproduct material modalities included.

(d) In addition to meeting the requirements of (a), (b), or (c) of this section, an

authorized medical physicist must have training in the modality for which

authorization is sought that includes “hands on” device operation, safety

procedures, clinical use, and operation of treatment planning system. This

training requirement may be satisfied by satisfactorily completing a training

program provided by the vendor or by training supervised by an AMP authorized

for the modality in which the individual is seeking authorization. 
5

§ 35.55 Training for an authorized nuclear pharmacist.

Except as provided in § 35.57, the licensee shall require the authorized nuclear pharmacist to

be a pharmacist who --

(a) Is certified as a nuclear pharmacist by Board of Pharmaceutical Specialties in

Nuclear Pharmacy; or

(b) Is certified as a Nuclear Pharmacist by a Nuclear Pharmacy specialty board

whose certification process has been recognized by the Commission and

requires that all diplomats:

(1) Have graduated from a pharmacy program accredited by the American

Council On Pharmaceutical Education (ACPE) or have passed the

Foreign Pharmacy Graduate Examination Committee (FPGEC)

examination;

(2) Hold a current, active license to practice pharmacy;

(3) Provide evidence of having acquired at least 4,000 hours of

training/experience in nuclear pharmacy practice. Academic training may

be substituted for no more than 2,000 hours of the required training and

experience.

(4) Pass an examination in nuclear pharmacy administered by diplomats of

the specialty board, which assesses knowledge and competency in

procurement, compounding, quality assurance, dispensing, distribution,

health and safety, provision of information and consultation, monitoring

patient outcomes, research and development; or

(c) (1) Has completed 700 hours in a structured educational program applicable

to consisting of

(i) Didactic training in the following areas 

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of

radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(ii) Supervised practical experience in a nuclear pharmacy involving --

(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, if appropriate, instruments used to

measure alpha or beta-emitting radionuclides;

(C) Calculating, assaying, and safely preparing dosages for

patients or human research subjects;

(D) Using administrative controls to avoid medical events in

the administration of byproduct material; and

(E) Using procedures to prevent or minimize radioactive

contamination and using proper decontamination

procedures; and

(2) Has obtained a written statement signed by a preceptor authorized

nuclear pharmacist (ANP) attesting that the individual has completed the

required training listed in (c)(1)(ii) of this section.

Sec. 35.190 Training for uptake, dilution, and excretion studies.
6

Except as provided in Sec. 35.57, the licensee shall require an authorized user of unsealed

byproduct material for the uses authorized under Sec. 35.100 to be a physician who--

(a) Is certified in--

 (1) Nuclear medicine by the American Board of Nuclear Medicine;

 (2) Diagnostic radiology by the American Board of Radiology;

 (3) Diagnostic radiology by the American Osteopathic Board of Radiology;

 (4) Nuclear medicine by the Royal College of Physicians and Surgeons of

Canada;

 (5) Nuclear medicine by the American Osteopathic Board of Nuclear

Medicine; or

(b) Is certified by a medical specialty board whose certification has been recognized

by the Commission and:

(1) Includes all of the requirements in paragraph (d) of this section; and

(2) Requires diplomats to pass an examination administered by diplomats of

the specialty board, which assesses knowledge and competence in

radiation safety, radionuclide handling, and quality control; or

(c) Is an authorized user under Secs. 35.290 or 35.390 or equivalent Agreement

State requirements; or

(d) (1) Has completed 60 hours of training and experience in basic radionuclide

handling techniques applicable to the medical use of unsealed byproduct

material for uptake, dilution, and excretion studies. The training and

experience must include--

(i) 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) Chemistry of byproduct material for medical use; and

 (E) Radiation biology; and

 (ii) Work experience, under the supervision of an authorized user

who meets the requirements in Sec. 35.190, Sec. 35.290, or Sec.

35.390 or equivalent Agreement State requirements, involving--

(A) Ordering, receiving, and unpacking radioactive materials

safely and performing the related radiation surveys;

 (B) Performing quality control procedures on instruments used

to determine the activity of dosages and performing

checks for proper operation of survey meters;

 (C) Calculating, measuring, and safely preparing patient or

human research subject dosages;

 (D) Using administrative controls to prevent a medical event

involving the use of unsealed byproduct material;

 (E) Using procedures to contain spilled byproduct material

safely and using proper decontamination procedures; and

 (F) Administering dosages of radioactive drugs to patients or

human research subjects; and

(2) Has obtained a written statement, signed by a preceptor authorized user

who meets the requirements in Secs. 35.190, 35.290, or 35.390 or

equivalent Agreement State requirements, or, if the training was received

in conjunction with a residency or fellowship program, a written statement

signed by the training program director, attesting that the individual has
7

satisfactorily completed the requirements in paragraph (d)(1) of this

section.

Sec. 35.290 Training for imaging and localization studies.

Except as provided in Sec. 35.57, the licensee shall require an authorized user of unsealed

byproduct material for the uses authorized under Sec. 35.200 to be a physician who--

(a) Is certified in--

 (1) Nuclear medicine by the American Board of Nuclear Medicine;

 (2) Diagnostic radiology by the American Board of Radiology;

 (3) Diagnostic radiology by the American Osteopathic Board of Radiology;

 (4) Nuclear medicine by the Royal College of Physicians and Surgeons of

Canada;

 (5) Nuclear medicine by the American Osteopathic Board of Nuclear

Medicine;

(6) Nuclear cardiology by the Certification Board of Nuclear Cardiology; or

(b) Is certified by a medical specialty board whose certification process has been

recognized by the Commission and:

(1) Includes all of the requirements in paragraph (d) of this section; and

(2) Requires diplomats to pass an examination administered by diplomats of

the specialty board, which assesses knowledge and competence in

radiation safety, radionuclide handling, and quality control; or

(c) Is an authorized user under Sec. 35.390 or equivalent Agreement State

requirements; or

 (d) (1) Has completed 700 hours of training and experience in basic radionuclide

handling techniques applicable to the medical use of unsealed byproduct

material for imaging and localization studies. The training and

experience must include, at a minimum,--

(i) 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) Chemistry of byproduct material for medical use;

 (E) Radiation biology; and

 (ii) Work experience, under the supervision of an authorized user,

who meets the requirements in Secs. 35.290 or 35.390 or

equivalent Agreement State requirements, involving–

 (A) Ordering, receiving, and unpacking radioactive materials

safely and performing the related radiation surveys;

 (B) Performing quality control procedures on instruments used

to determine the activity of dosages and performing

checks for proper operation of survey meters;

 (C) Calculating, measuring, and safely preparing patient or

human research subject dosages;

 (D) Using administrative controls to prevent a medical event

involving the use of unsealed byproduct material;

 (E) Using procedures to safely contain spilled radioactive

material and using proper decontamination procedures;

 (F) Administering dosages of radioactive drugs to patients or

human research subjects; and
8

 (G) Eluting generator systems appropriate for preparation of

radioactive drugs for imaging and localization studies,

measuring and testing the eluate for radionuclidic purity,

and processing the eluate with reagent kits to prepare

labeled radioactive drugs; and

(2) Has obtained a written statement, signed by a preceptor authorized user

who meets the requirements in Secs. 35.290 or 35.390 or equivalent

Agreement State requirements, or, if the training was received in

conjunction with a residency or fellowship program, a written statement

signed by the training program director, attesting that the individual has

satisfactorily completed the requirements in paragraph (d)(1) of this

section.

Sec. 35.390 Training for use of unsealed byproduct material for which a written directive

is required.

Except as provided in Sec. 35.57, the licensee shall require an authorized user of unsealed

byproduct material for the uses authorized under Sec. 35.300 to be a physician who 

(a) is certified by 

(1) The American Board of Nuclear Medicine;

(2) The American Board of Radiology in radiation oncology;

 (3) The Royal College of Physicians and Surgeons of Canada in nuclear

medicine or radiation oncology; 

 (4) The British Royal College of Radiology in radiation oncology; or

(5) The American Osteopathic Board of Radiology in radiation oncology; or

 (b) Is certified by a medical specialty board whose certification has been recognized

by the Commission and requires all diplomats

(1) To successfully complete a minimum of three years of residency training

in a radiation oncology or nuclear medicine training program or a program

in a related medical specialty that includes 700 hours of training and

experience as described in paragraphs (c)(1) of this section. Eligible

training programs must be approved by the Residency Review

Committee of the Accreditation Council for Graduate Medical Education

or Royal College of Physicians and Surgeons of Canada or the

Committee on Post-Graduate Training of the American Osteopathic

Association; 

(2) To provide a written statement from the residency program director

attesting to successful completion of the training requirement in

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

(3) To pass an examination administered by diplomats of the specialty board,

which tests knowledge and competence in radiation safety, radionuclide

handling, quality assurance, and clinical use of unsealed byproduct

material; or

 (c) (1) Has completed 700 hours of training and experience in basic radionuclide

handling techniques applicable to the medical use of unsealed byproduct

material requiring a written directive. This training and experience must

include--

 (i) 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; 
9

(D) Chemistry of byproduct material for medical use; and 

 (E) Radiation biology; and

 (ii) Work experience, under the supervision of an authorized user

who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), or

equivalent Agreement State requirements. A supervising

authorized user, who meets the requirements in Sec. 35.390(b),

must have experience in administering dosages in the same

dosage category or categories (i.e., Sec. 35.390(b)(1)(G)(1), (2),

(3), or (4)) as the individual requesting authorized user status. 

This work experience must involve-- 

(A) Ordering, receiving, and unpacking radioactive materials

safely and performing the related radiation surveys;

(B) Performing quality control procedures on instruments used

to determined the activity of dosages, and performing

checks for proper operation of survey meters; 

(C) Calculating, measuring, and safely preparing patient or

human research subject dosages; 

(D) Using administrative controls to prevent a medical event

involving the use of unsealed byproduct material; 

(E) Using procedures to contain spilled byproduct material

safely and using proper decontamination procedures;

(F) Eluting generator systems, measuring and testing the

eluate for radionuclidic purity, and processing the eluate

with reagent kits to prepare labeled radioactive drugs; and

(2) Has obtained written statement attesting that the individual has

satisfactorily completed the requirements in paragraph (b)(1) of this

section. The written statement must be signed by a preceptor authorized

user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), or

equivalent Agreement State requirements, or, if the training was received

in conjunction with a residency or fellowship program, the written

statement must be signed by the training program director. The

preceptor authorized user, who meets the requirements in Sec.

35.390(b), must have experience in administering dosages in the same

dosage category or categories (i.e., Sec. 35.390(d)(1), (2), (3), or (4)) as

the individual requesting authorized user status. 

(d) In addition to meeting the requirements of (a), (b), or (c) of this section, an

authorized user of byproduct material authorized under 35.300 must have

experience, under the supervision of an authorized user, administering dosages

of radioactive drugs to patients or human research subjects involving 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) or sodium iodide I-131; 

(2) Oral administration of greater than 1.22 Gigabecquerels (33 millicuries)

or sodium iodide I-131. Experience with at least three cases in Category

(d)(2) also satisfies the requirement in Category (d)(1); 

(3) Parenteral administration of therapeutic quantities of any beta emitter or

a photon-emitting radionuclide with a photon energy less than 150 keV; 

(4) Parenteral administration of any other radionuclide in therapeutic

quantities.
10

Sec. 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) (3) Has obtained written statement attesting that the individual has

satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2)

of this section. [competency statement removed]. The written

certification must be signed by [....remainder of paragraph unchanged] 

Sec. 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) (3) Has obtained written statement attesting that the individual has

satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2)

of this section. [competency statement removed]. The written

certification must be signed by [....remainder of paragraph unchanged] 

Sec. 35.490 Training for use of manual brachytherapy sources.

Except as provided in Sec. 35.57, the licensee shall require an authorized user of a manual

brachytherapy for the uses authorized under Sec. 35.400 to be a physician who—

(a) Is certified by 

(1) The American Board of Radiology in radiation oncology;

(2) The Royal College of Physicians and Surgeons of Canada in radiation

oncology;

 (3) The British Royal College of Radiology in radiation oncology; or

(4) The American Osteopathic Board of Radiology in radiation oncology; or

(b) Is certified by a medical specialty board whose certification has been recognized 

by the Commission and requires all diplomats

(1) To successfully complete a minimum of three years of residency training

in a radiation oncology program approved by the Residency Review

Committee of the Accreditation Council for Graduate Medical Education

or Royal College of Physicians and Surgeons of Canada or the

Committee on Post-Graduate Training of the American Osteopathic

Association; 

(2) To obtain a written statement from the residency program director 

attesting to successful completion of the training requirement in

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

(3) To pass an examination administered by diplomats of the specialty board,

which tests knowledge and competence in radiation safety, radionuclide

handling, treatment planning, quality assurance, and clinical use of high

and low dose-rate brachytherapy; or

(c) (1) Has completed a structured educational program in basic radionuclide

techniques applicable to the use of manual brachytherapy sources that

includes--

 (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; and

 (D) Radiation biology; and
11

 (ii) 500 hours of work experience, under the supervision of an

authorized user who meets the requirements in Sec. 35.490 or

equivalent Agreement State requirements at a medical institution,

involving--

(A) Ordering, receiving, and unpacking radioactive materials

safely and performing the related radiation surveys:

(B) Checking survey meters for proper operation;

 (C) Preparing, implanting, and removing brachytherapy 

sources; 

(D) Maintaining inventories of material on hand; 

(E) Using administrative controls to prevent a medical event

involving the use of byproduct material;

(F) Using emergency procedures to control byproduct

material; and

(2) Has completed 3 years of supervised clinical experience in radiation

oncology, under an authorized user who meets the requirements in Sec.

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 (c)(1) of this section;

and

(3) Has obtained a written statement attesting that the individual has

satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2)

of this section. The written certification must be signed by the

supervising authorized user or if the training was obtained in a residency

training program, by the program director. 

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

(b) (3) Has obtained a written statement signed by a preceptor authorized user 

who meets the requirements in Sec. 35.490, Sec. 35.491, or equivalent

Agreement State requirements, attesting that the individual has

satisfactorily completed the requirements in paragraphs (a) and (b) of this

section. [competency statement removed].

Sec. 35.590 Training for use of sealed sources for diagnosis.

Except as provided in Sec. 35.57, the licensee shall require the authorized user of a diagnostic

sealed source for use in a device authorized under Sec. 35.500 to be a physician, dentist, or

podiatrist who–

(a) Is certified in–

(1) Diagnostic radiology, or radiation oncology by the American Board of

Radiology;

 (2) Nuclear medicine by the American Board of Nuclear Medicine;

 (3) Diagnostic radiology by the American Osteopathic Board of Radiology; or

 (4) Nuclear medicine by the Royal College of Physicians and Surgeons of

Canada; or
12

 (b) Is certified by a specialty board whose certification has been recognized by the

Commission and includes all of the requirements in paragraph (c) of this section;

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.

(d) In addition to meeting the requirements of paragraph (a), (b), or (c) of this

section, an authorized user under this section must have training in the use of

the device for the uses requested.

Sec. 35.690 Training for use of remote afterloader units, teletherapy units, and gamma

stereotactic radiosurgery units.

Except as provided in Sec. 35.57, the licensee shall require an authorized user of a sealed

source for a use authorized under Sec. 35.600 to be a physician who—

(a) Is certified by 

(1) The American Board of Radiology in radiation oncology;

(2) The Royal College of Physicians and Surgeons of Canada in radiation

oncology; 

(3) The British Royal College of Radiology in radiation oncology; or

(4) The American Osteopathic Board of Radiology in radiation oncology; or

(b) Is certified by a specialty board whose certification has been recognized by the

Commission and requires all diplomats

(1) To successfully complete a minimum of three years of residency training

in a radiation oncology program approved by the Residency Review

Committee of the Accreditation Council for Graduate Medical Education

or Royal College of Physicians and Surgeons of Canada or the

Committee on Post-Graduate Training of the American Osteopathic

Association;

 (2) To obtain a written statement from the residency program director 

attesting to successful completion of the training requirement in

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

(3) To pass an examination administered by diplomats of the specialty board,

which tests knowledge and competence in radiation safety, radionuclide

handling, treatment planning, quality assurance, and clinical use of

stereotactic radiosurgery, high and low dose-rate brachytherapy, and

external beam therapy; or

(c) (1) Has completed a structured educational program in basic radionuclide

techniques applicable to the use of a sealed source in a therapeutic

medical unit that includes--

 (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; and

 (D) Radiation biology; and
13

 (ii) 500 hours of work experience, under the supervision of an

authorized user who meets the requirements in Sec. 35.690 or

equivalent Agreement State requirements at a medical institution,

involving--

(A) Reviewing full calibration measurements and periodic 

spot-checks;

(B) Preparing treatment plans and calculating treatment doses

and times;

 (C) Using administrative controls to prevent a medical event

involving the use of byproduct material;

(D) Implementing emergency procedures to be followed in the

event of the abnormal operation of the medical unit or

console;

 (E) Checking and using survey meters; and

(F) Selecting the proper dose and how it is to be administered;

and

 (2) Has completed 3 years of supervised clinical experience in radiation

oncology, under an authorized user who meets the requirements in Sec.

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 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 (c)(1) of this section;

and

(3) Has obtained a written statement attesting that the individual has

satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2)

of this. The written statement must be signed by the supervising

authorized user or if the training was obtained in a residency training

program, by the program director. 

(d) In addition to meeting the requirements of paragraphs (a), (b), or (c) of this 

section, an authorized user of a sealed source authorized under 35.600 must

have training in the modality for which authorization is sought. This includes

training in device operation, safety procedures, and clinical use. This training

requirement may be satisfied by satisfactorily completing the training program

provided by the vendor for new users or by receiving training supervised by an

authorized user or authorized medical physicist, as appropriate, who is

authorized for the modality in which the individual is seeking authorization.
1

ATTACHMENT 3

AGREEMENT STATES COMMENT LETTERS 

From: "Johns, George" <GJOHNS@health.state.ia.us>

To: "'lmp1@nrc.gov'" <lmp1@nrc.gov>

Date: 8/8/02 12:29PM

Subject: Iowa's response to Draft Options Paper on Part 35 Training and Experience

The Chief of Iowa's Bureau of Radiological Health has reviewed the following

and requested that it be forwarded to you.

The current rule requires 200 hours of classroom training, 500 hours of

supervised clinical experience and 500 hours of supervised work experience

for use of radiopharmaceuticals in imaging and localization studies. The

new rule states that a physician must only have 750 hours and is

non-specific. Based on the Draft Options Paper, it would appear that the

board certifications do not even meet the reduced standards, which take

effect October 24, 2002. In other words, despite a 500-hour reduction in

the training and experience requirements, only the Certification Board of

Nuclear Cardiology meets the new NRC standards.

If the board certification process includes testing, which effectively

evaluates a physician's didactic and clinical knowledge, IDPH would normally

have little problem accepting that certification. However, because the

regulatory community is tasked with promulgating rules to protect the health

and safety of the patient, the staff, and the physician, the question that

arises is: How much training can be avoided without compromising health and

safety? 

It seems odd that a certifying body would not be interested in establishing

consistent training and experience standards. IDPH does not agree that the

standards should be altered to accommodate the boards.

The certification process, if properly designed, can be used to determine

competency. However, when considering training for non-board certified

physicians, the difficulty that arises is determining how much training and

experience should be required in lieu of a board certification. I believe

that the primary objection expressed by many other Agreement States is that

the NRC appears to be proposing a lesser training and experience standard

for physicians with a board certification. Again, the standard has already

been diminished. At what point does the NRC wish to say that the level of

training is too little? It would appear that the NRC believes that the

certification boards are capable of making that decision. It is Iowa's

opinion that the NRC should not abdicate its responsibility. 

In summary, the NRC has determined that regulations pertaining to training

and experience are a Compatibility B. The final rule has already reduced
2

the training and experience requirements to a level that many believe to be

compromising health and safety. The standard should not be further

compromised. Therefore, the certifying boards, which have inconsistent

standards among themselves, should be held to the new standards. Board

certified and non-certified physicians should meet those same standards.

Finally, if Agreement States are required to be consistent with the NRC,

IDPH believes that the training and experience for physicians should be also

consistent.
3

From: "Frazee, Terry" <Terry.Frazee@DOH.WA.GOV>

To: "'LMP1@nrc.gov'" <LMP1@nrc.gov>

Date: 8/27/02 1:28PM

Subject: STP-02-061 -- Comments on Part 35 T&E

I have reviewed the Draft Options Paper presented on the Technical

Conference Forum and have the following comments:

The ACMUI request is proof of what the Agreement States have known for a

long time -- "Authorized Users" are clinicians (or "authorized prescribers",

if you will) and, for the most part, NOT "users" or "handlers" of

radioactive material; and obviously the Board process reflects that. The

new T&E regulations (Option 1) are written as minimum requirements for the

"use" or handling of radioactive material, i.e., with radiation safety in

mind, and should be maintained "as is". An eleventh hour realization that

the "clinical practice" Boards are "just that" does not negate the value of

the T&E requirements geared to radiation safety!

Bottom line: The training and experience requirements represent the MINIMUM

radiation safety requirements applicable to ALL "users" (even Board

certified individuals) and should be kept for ALL. We don't "buy" the

shortage argument. The Boards have two years to show how they meet (or will

meet) or exceed the minimum requirements. Even if the ACMUI (rather than

NRC staff) is used to "approve" Boards, the standard should be the same.

Professional judgment can be used, BUT the STANDARD remains the same. The

concern that "candidates seeking authorized user status may bypass the board

certification pathway and select the simpler T&E process" is more reflective

of Board concern for losing its candidates than for diminution of radiation

safety. Our concern as regulators should be that the individuals we approve

as "authorized users" are adequately trained with sufficient experience to

handle the radioactive materials safely. Our first responsibility is to "do

it right", not just pick the "easy way". 

Therefore:

1. Leave the basic T&E alone. A lot of time and effort has been expended

getting the "minimum" radiation safety standard to this point. "Last

minute" changes are suspect.

2. Modify the certification (preceptor) requirement as recommended by ACMUI.

This makes sense for Board certifications and further makes it clear that

radiation safety rather than clinical skills are the focus of the regulatory

requirement.

3. Set specific training requirements for new devices or modalities that can

build upon the basic requirements for existing modalities. Existing

authorized users should already have the basic radiation safety training and

experience and need only specific training for the new device or modality.
4

4. Publish "Approved Boards" on the web site (and not in regulation) for

ease and convenience of all concerned.

If there are any lessons to be learned here, one is: "license the techs" and

leave the physicians to their Boards (with ACMUI setting the bar for

"authorized prescribers"); and the other is: last minute jockeying to change

the "standard" means the rule may not be "perfect" and therefore "casting it

in concrete" (compatibility B) may be premature!

Note to Agreement States: comments are due by August 30!

***********************************

"The Department of Health works to protect and improve the health of people

in Washington State"

***********************************

This message from Terry C. Frazee

e-mail terry.frazee@doh.wa.gov

Quick ways to reach me:

Voice = 360-236-3221

FAX = 360-236-2255

Also, visit our Home Page at

http://www.doh.wa.gov/ehp/rp

CC: "NRC-Lloyd (E-mail)" <lab@nrc.gov>, "AL-KirkseyWhatley (E-mail)"

<kwhatley@adph.state.al.us>, "AR-JaredThompson (E-mail)"

<jwthompson@healthyarkansas.com>, "AZ-AubreyGodwin (E-mail)"

<agodwin@arra.state.az.us>, "CA-EdBailey (E-mail)" <EBailey@dhs.ca.gov>,

"CA-KentPrendergast (E-mail)" <KPrender@dhs.ca.gov>, "CO-JakeJacobi (E-mail)"

<jake.jacobi@state.co.us>, "FL-BillPassetti (E-mail)" <bill_passetti@doh.state.fl.us>,

"GA-TomHill (E-mail)" <thill@dnr-gwia2.dnr.state.ga.us>, "IA-Flater (E-mail)"

<dflater@idph.state.ia.us>, "IL-Collins (E-mail)" <collins@idns.state.il.us>, "KS-TomConley

(E-mail)" <tconley@kdhe.state.ks.us>, "LA-MikeHenry (E-mail)" <m_henry@ldeq.org>,

"MD-RolandFletcher (E-mail)" <rfletcher@mde.state.md.us>, "MA-Hallisey (E-mail)"

<bob.hallisey@state.ma.us>, "MS-RobertGoff (E-mail)" <rgoff@msdh.state.ms.us>,

"NC-BevHall (E-mail)" <beverly.hall@ncmail.net>, "ND-KenWangler (E-mail)"

<kwangler@state.nd.us>, "ND-TerryOclair (E-mail)" <toclair@state.nd.us>, "NE-JuliaSchmitt

(E-mail)" <julia.schmitt@hhss.state.ne.us>, "NH-WayneJohnston (E-mail)"

<wjohnsto@dhhs.state.nh.us>, "NM-BillFloyd (E-mail)" <william_floyd@nmenv.state.nm.us>,

"NV-StanMarshall (E-mail)" <smarshall@bhps.state.nv.us>, "NYCH-GeneMiskin (E-mail)"

<gmiskin@health.nyc.gov>, "NYDEC-Merges (E-mail 2)" <pjmerges@gw.dec.state.ny.us>,

"NYDOL-Brandt (E-mail)" <usccjb@labor.state.ny.us>, "NYSH-Salame-Aflie (E-mail)"

<asa01@health.state.ny.us>, "OH-Suppes (E-mail)" <rsuppes@gw.odh.state.oh.us>,

"OK-MikeBroderick (E-mail)" <mike.broderick@deq.state.ok.us>, "OR-TerryLindsey (E-mail)"

<terry.d.lindsey@state.or.us>, "RI-MarieStoeckel (E-mail)" <maries@doh.state.ri.us>,
5

"SC-HenryPorter (E-mail)" <porterhj@dhec.state.sc.us>, "SC-PearceO'Kelley (E-mail)"

<okelletp@dhec.state.sc.us>, "TN-EddieNanney (E-mail)" <enanney@mail.state.tn.us>,

"TX-McBurney (E-mail)" <ruth.mcburney@tdh.state.tx.us>, "TX-Ratliff (E-mail)"

<richard.ratliff@tdh.state.tx.us>, "UT-Sinclair (E-mail)" <bsinclair@utah.gov>, "Demaris, Curt"

<Curt.Demaris@DOH.WA.GOV>, "Robertson, Gary" <Gary.Robertson@DOH.WA.GOV>
6

STATE OF ILLINOIS

DEPARTMENT OF NUCLEAR SAFETY

1035 OUTER PARK DRIVE • SPRINGFIELD, ILLINOIS 62704

217-785-9900 • 217-782-6133 (TDD)

 George H. Ryan Thomas W. Ortciger

 Governor Director

September 11, 2002

 

U.S. Nuclear Regulatory Commission

ATTN: Linda M. Psyk, NMSS

Mail Stop TWFN 8-F-5

Washington, D.C. 20555

Re: Draft Options Paper, Part 35 - Training and Experience Requirements

 (STP-02-061)

 

Dear Ms. Psyk:

The Illinois Department of Nuclear Safety hereby submits the following comments

on the above-identified draft options paper. The paper describes a recommendation by

the NRC's Advisory Committee for Medical Use of Isotopes (ACMUI). The

recommendation suggests a basis for the NRC to recognize training approved by

professional specialty boards and provides an alternative training and experience pathway 

for individuals without board certification. It also proposes training and experience

requirements for those working with remote afterloaders and gamma stereotactic

radiosurgery units. The options paper concludes that the NRC should accept the advisory

committee's recommendation.

Except for misgivings about the ACMUI’s idea for the preceptor concept, the 

Department of Nuclear Safety does not object to either the advisory committee's

recommendation or the NRC's plan to list recognized specialty boards on its website

instead of in Part 35. We believe that with one additional change, the ACMUI's

recommendation would provide effective training and experience requirements. We also

have suggestions that would clarify the NRC's expectations for training of individuals

working with future technologies.

The Preceptor Concept. We strongly oppose the idea of reducing the amount of

assurance required of a preceptor when vouching for an individual seeking authorized

status on a medical use license. The revision of Part 35 that will go into effect on

October 24, 2002, requires a preceptor to verify that the individual is competent to
7

U.S. Nucler Regulatory Commission

September 11, 2002

Page 2

perform independently the duties required by a medical use license. The Department of

Nuclear Safety believes that this principle must be preserved if the revision is to be

effective over time.

The ACMUI recommends two traming and experience pathways leading to

authorized status on a license. The more common track is certification by a professional

specialty board. The Department of Nuclear Safety supports the ACMUI's vision of how

this should be done. We believe that the board certification process contains

prerequisites, inherent milestones, and internal certifications that are predictive of

effective performance by board-certified individuals. We expect these individuals 

typically to be competent in the duties required by a medical use license.

The alternative training and experience pathway provides a method other than

board certification for an individual to achieve authorized status on a medical use license.

It allows the individual to acquire training and experience and then furnish a preceptor

statement asserting that he or she is prepared to effectively perform the duties required by

a license. Although this is a valid process overall, we strongly oppose the ACMUI's idea

of reducing the assurance that would be required of a preceptor. Instead of an attestation

of competency, the ACMUI wants the NRC to require only verification that training was

completed. Thus, the NRC is asked to accept less assurance of competency from the

alternative pathway than through board certification.

The NRC removed many prescriptive requirements from the revision of Part 35, in

part because of assurances that the regulated community would assume increased

responsibility for the performance of its members. Indeed, when the revision was being

drafted, the ACMUI was not opposed to preceptors appraising the competence of

individuals seeking authorized status on medical use licenses. We believe that the

ACMUI recognized the need for increased self-regulation if Part 35 were to become more

performance-based.

In the interim, however, it appears that a misunderstanding has arisen between the

ACMUI and the NRC. We believe that the wording of the revision of Part 35 has led the

ACMUI to conclude that the NRC is seeking a guarantee of clinical competency. Instead

of such a broad guarantee, we believe that the NRC actually requires only an opinion

about the ability of an individual to independently perform the duties required by a

license. This opinion would not require the preceptor to vouch for the individual's

overall clinical competency.
8

U.S. Nuclear Regulatory Commission

September 11, 2002

Page 3

We believe that the positions of both the NRC and the regulated community would

be served if this nuance were clarified. Here is a suggestion to modify the several

requirements for preceptor statements in Part 35:

Has obtained a written statement attesting that the individual has satisfactorily

completed the requirements in paragraph of this section. The written

statement shall be signed by a preceptor who meets the requirements in

 or equivalent Agreement State requirements, and shall include verification

that, to the preceptor's best knowledge, the individual is competent to function

independently as an for-the medical uses authorized under .

Future Technologies. The ACMUI's recommendation includes a training

requirement for remote afterloaders and gamma stereotactic radiosurgery units. The

recommendation would require modality-specific training in device operation, safety

procedures, and clinical use. The Department of Nuclear Safety supports this

recommendation.

Besides the training requirements for the above modalities, however, we suggest

that the NRC also identify its training expectations for future technologies. Here is a

clarification to subsection 35.12(d) of Part 35 that we believe would accomplish this:

35.12(d)(1)(iv) Specialized training beyond that described in paragraph (b)(l) of

this section. A radiation safety officer, authorized user, authorized medical

physicist, or authorized nuclear pharmacist for a use authorized under section

35.1000 shall have training in the use for which authorization is sought. This

includes training in device operation, safety procedures, and clinical use. This

training requirement may be satisfied by satisfactorily completing the training

program provided by the vendor for the appropriate position. It may also be

satisfied by receiving training supervised by a radiation safety officer, authorized 

user, authorized medical physicist, or authorized nuclear pharmacist, as

appropriate, who is authorized for the use for which authorization is sought.

A Role for the ACMUI. The Department of Nuclear Safety believes that the

ACMUI should assume an active role in establishing specific training and experience

criteria for future technologies. We suggest that the NRC ask the advisory committee to

recommend training specifics for each new use under section 35.1000. This

recommendation should describe the training and experience qualifications necessary

under paragraph (b)(l) of section 35.12. It should also specify the number of hours or

cases required to satisfy the specialized training requirement suggested above [new

paragraph (d)(1)(iv)]. This practice would capitalize on the advisory committee's 

familiarity and expertise in new technologies.
9

U.S. Nuclear Regulatory Commission

September 11, 2002

Page 4

After evaluating the ACMUI's recommendation, the NRC should promptly post

new training and experience requirements on its website. This would make them quickly

available to the regulated community and the Agreement States, thereby standardizing

requirements for new technologies as they emerge.

Thank you for the opportunity to comment on this draft options paper. My

telephone number is 217-785-9930 if you have questions or comments.

Sincerely,

Joseph G. Klinger, Chief

Division of Radioactive Materials

JGK:kjg

cc: Jim Lynch

NRC Region III
10

Linda M. Psyk, NMSS

U.S. Nuclear Regulatory Commission

Mail Stop TWFN 8-F-5

Washington, DC 20555 

 Re: STP-02-061 - Part 35 - Training and Experience Requirements

Dear Ms Psyk:

This letter serves as my comment on the above referenced document. I have

submitted comments to you earlier, via e-mail, regarding the ACMUI

Subcommittee recommendation dated July 17, 2002.

In reading the above document, I find some inaccurate statements. The following

is my response to each of these items.

1) If the draft final rule became effective 6 months after the

publication date, there could be potential shortages of authorized

individuals. 

Response: This appears to be a key item of concern to the ACMUI. However,

I fail to see the problem. During the last few years, nuclear

cardiologists have not had a board certification available to them,

yet there has been no shortage of nuclear cardiologists applying for,

and receiving, authorized user status. 

2) The ACMUI expressed concern that the boards may become

“marginalized”, because potential candidates seeking authorized

user status may bypass the board certification pathway and select

the simpler T&E process.

Response: When the NRC revised Part 35 in the 1980's, the various boards

were queried as to their radiation safety requirements for board

eligibility. These requirements became the basis for the optional

training and experience requirements. Therefore, an individual

who was not board certified, was required to be board eligible (in

regards to radiation safety) in order to be approved as an authorized

user. If any changes were made to the radiation safety training and

experience required to sit for a board listed in Part 35, the NRC

should have been made aware so they could review the possible

impacts on radiation safety.

During the rule revision process, the Part 35 Working Group (of

which I was a member) spent many hours with the ACMUI as well
11

as their subcommittees for diagnostic and therapeutic uses. Many

changes were made in the training and experience requirements

based on the discussions and recommendations of the members. It

was made very clear that only those boards that showed they

required that a board candidate meet the optional training and

experience requirements would be "recognized" by the NRC, and

placed on the on the NRC website list. Over and over again,

between 1998 and 2000, the ACMUI membership expressed

understanding and approval of the Working Group's revisions to

the training and experience requirements.

Board certification should represent the best the respective field

has to offer! Certification isn’t for everyone. Certification should

indicate that an individual has “gone the extra mile”, not only to be

the best they can be in their field, but to continue to strive to

maintain that high level of overall competence in their chosen

profession. Surely being board certified is worth more than just

the ability to easily become an authorized user on a radioactive

material license!

I perceive the currently listed boards did not pay attention to the

revised training and experience requirements, so they are not

prepared for the implementation of the new rule. I do not see this

as a reason for changing the rule. I commend the Certification

Board of Nuclear Cardiology for being attentive to the revised rule,

and preparing for its implementation.

The following are my responses to the discussion topics.

1) Under the current Part 35, boards are not required to meet specific

didactic/laboratory training and experience requirements to attain

NRC recognition.

Response: As I stated above, when the training and experience requirements

were revised during the 1980's, the intent was that the boards

would meet the specified didactic/laboratory training and

experience requirements to attain NRC recognition. However, this

intent seems to have been forgotten over the years. The revised

rule only reaffirms the old intent, leaving no doubt to a perspective

board as to what radiation safety training and experience

requirements they must have to attain NRC recognition.

2) Under the current rule, preceptor certification is not required for

board certification. During the board certification process, the
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board makes its judgement that a candidate has satisfactorily

completed the board’s program and that the individual will be able

to carry out the duties of this certification. Could another qualified

individual (e.g. a program director, a department head, or a

professor) also sign the certification? In the case of the board

certification process, can the members of the board collectively act

as a “preceptor”?

Response: I again state that the intent of the current rule was that the boards

require preceptor certification. I do not have a 1980's NRC

definition for “preceptor”, so I cannot say that the definition has

not changed. In the revised rule, Preceptor is defined as “...an

individual who provides or directs the training and experience

required for an individual to become an authorized user, an

authorized medical physicist, an authorized nuclear pharmacist, or

a Radiation Safety Officer”. Using this definition would not allow

the boards to accept certification from a “qualified individual”.

I believe that another individual can be allowed to sign on behalf of

the actual preceptors. However, such an individual should be the

preceptor’s supervisor, such as a department head or program

director, and a list of the preceptors should be included as

reference.

I do not believe that members of the board, who have no personal

knowledge of the “qualified individual”, should be able to

collectively act as a preceptor. I believe the “qualified individual”

should be able to submit signatures of preceptors, or the

preceptor’s supervisor as specified in the previous paragraph, as

part of their qualifications. The members of the board could decide

to allow an individual to participate in any examination process

without the individual submitting the necessary preceptor

signatures. However, final certification should be withheld until

the required preceptor signatures are submitted.

3) Board programs do not specifically include training and experience

requirements for new modalities.

Response: It was the intent of the working group, in conjunction with

recommendations from the ACMUI, that the training and

experience requirements for other medical uses of byproduct

material (emerging technologies) be handled on a case-by-case

basis. No one can currently state what isotopes, chemical forms,

physical forms, or routes of administration will fall into this area in
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the years to come. That is the reason the rule seems so vague. The

intent is to make clear to the licensee what will be required of them

to request licensed use of a new medical use not covered by the

current rules. The example of a medical physicist with no

experience in the use of an HDR does not fall under this rule. 

Rather, it falls under 35.51. To try and tie down 35.1000 to

something we are currently aware of has been pointed out as

improper in public meetings. Specifically, the working group was

using intravascular brachytherapy as an example of an emerging

technology covered under this rule. Cardiologists and physicists

pointed out that they do not consider intravascular brachytherapy

an emerging technology. They consider it a current technology.

Existing qualified individuals wishing to use emerging

technologies will have to submit information regarding the

radiation safety hazards of the use to the NRC, and the NRC will

then determine the necessary radiation safety training and

experience requirements to become an authorized user, authorized

medical physicist, etc.

Regarding the two options, my recommendation is as follows:

I believe the NRC should adopt Option 1, with two caveats. The ability of the

Certification Board of Nuclear Cardiology to meet the revised requirements has

proven that it can be done. However, the NRC could consider extending the old

Subpart J training and experience requirements, as they are currently, until

October 24, 2004. This gives the current boards another two years to meet the

new requirements. 

I also believe the NRC should allow the boards to accept another individual to

sign on behalf of the actual preceptor, as long as the individual is the preceptor’s

supervisor, such as a department head or program director, and they submit a list

of the preceptors as a reference.
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Thank you for the opportunity to comment on this options paper. Should you

have any questions, please feel free to contact me at 334-206-5391, or by e-mail at

dwalter@adph.state.al.us.

Sincerely,

David Walter, Director

Radioactive Materials Licensing

Alabama Office of Radiation Control