[Federal Register Volume 65, Number 213 (Thursday, November 2, 2000)]
[Proposed Rules]
[Pages 65793-65798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27940]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

RIN 3150-AF74


Medical Use of Byproduct Material--Speciality Boards and Medical 
Speciality Boards: Solicitation

AGENCY: Nuclear Regulatory Commission.

ACTION: Solicitation.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is beginning a new 
process to recognize speciality boards and medical speciality boards 
(whose diplomates would fulfill the training and experience 
requirements for an authorized medical physicist, authorized nuclear 
pharmacist, authorized user, and/or a Radiation Safety Officer) by 
listing the boards on an NRC website instead of including the names of 
boards in 10 CFR Part 35, ``Medical Use of Byproduct Material.'' The 
NRC is taking this action in anticipation of a revision to its 
regulations governing the medical use of byproduct material. Any board 
that is interested in being recognized by the NRC should submit a 
letter certifying that its certification process would meet the draft 
final training and experience requirements for an authorized medical 
physicist, authorized nuclear pharmacist, authorized user, and/or a 
Radiation Safety Officer.

DATES: The solicitation process begins November 2, 2000.

ADDRESSES: Documents related to the proposed rule may be examined 
through September 22, 2000, at the NRC Public Document Room and 
electronically at http://ruleforum.llnl.gov. Beginning September 25, 
2000, the NRC Public Document Room will be located at 11555 Rockville 
Pike, Rockville, MD.

FOR FURTHER INFORMATION CONTACT: Sam Jones, Office of Nuclear Material 
Safety

[[Page 65794]]

and Safeguards, Nuclear Regulatory Commission, Washington, DC 20555-
0001, (301) 415-6198, e-mail <a href="/cdn-cgi/l/email-protection#7f2c25353f110d1c51181009"><span class="__cf_email__" data-cfemail="44171e0e042a36276a232b32">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Discussion

    The NRC is in the final stages of revising its medical use 
regulations in 10 CFR Part 35, ``Medical Use of Byproduct Material.'' 
The proposed rule revising Part 35 was published August 13, 1998 (63 FR 
43516). It is anticipated that the Commission will publish the final 
rule in the Federal Register in Spring 2001 with an effective date 6 
months after publication. As part of this revision, the regulatory text 
would not include the names of the specific boards whose diplomates 
automatically fulfill the training and experience requirements for an 
authorized medical physicist, authorized nuclear pharmacist, authorized 
user and a Radiation Safety Officer. Rather, the NRC will recognize 
certification boards that require individuals to complete the training 
and experience requirements specified in the regulatory text. This 
change is being made to eliminate the need for a rulemaking each time a 
board is added or deleted. Once recognized, the board's name will be 
placed on the list of recognized boards to be maintained on the NRC 
website. NRC expects to begin listing the names of boards on an NRC 
website prior to the effective date of the final rule.
    This document serves as notification to all speciality boards of 
NRC's intent to initiate the recognition process immediately. If any 
board is interested in being recognized by the NRC, the board should 
submit a letter to Dr. Donald A. Cool, Director, Office of Nuclear 
Material Safety and Safeguards, Nuclear Regulatory Commission, 
Washington, DC 20555-0001. The letter should list each training and 
experience section of the rule for which the board believes that their 
diplomates should be deemed to have met the requirements. Section II 
and Section III of the SUPPLEMENTARY INFORMATION should assist a board 
in preparing its letter. Section II lists all training requirements for 
which NRC plans to recognize board certification as meeting the 
requirements. Section III is a copy of the draft final regulatory text 
that lists the training and experience criteria for an authorized 
medical physicist, authorized nuclear pharmacist, authorized user and a 
Radiation Safety Officer.
    The board's letter should clearly state that an individual must 
have completed the training and experience required by a particular 
section prior to receiving board certification. For example, if a board 
would like to be recognized under 10 CFR 35.390. ``Training for use of 
unsealed byproduct material for which a written directive is 
required,'' the letter should state: ``(the name of the organization) 
has reviewed 10 CFR 35.390 and has determined that our certification 
process requires an individual to meet all the requirements in 
paragraph (b) of this section prior to being certified by our board.'' 
The letter should be dated and signed by the chief executive of the 
board.

II. Training Requirements for Which NRC Plans To Recognize Board 
Certification

    The following are the titles of the specific sections in the draft 
final regulations that contain the specific training and experience 
requirements for a Radiation Safety Officer, an authorized medical 
physicist, authorized nuclear pharmacist, and authorized user:

35.50   Training for Radiation Safety Officer.
35.51   Training for an authorized medical physicist.
35.55   Training for an authorized nuclear pharmacist.
35.190   Training for uptake, dilution, and excretion studies.
35.290   Training for imaging and localization studies.
35.390   Training for use of unsealed byproduct material for which a 
written directive is required.
35.392   Training for the oral administration of sodium iodide I-131 
requiring a written directive in quantities less than or equal to 
1.22 Gigabecquerels (33 millicuries).
35.394   Training for the oral administration of sodium iodide I-131 
requiring a written directive in quantities greater than 1.22 
Gigabecquerels (33 millicuries).
35.490   Training for use of manual brachytherapy sources.
35.491   Training for ophthalmic use of strontium-90.
35.590   Training for use of sealed sources for diagnosis.
35.690   Training for use of remote afterloader units, teletherapy 
units, and gamma stereotactic radiosurgery units.

III. Draft Final Regulatory Text--Training and Experience

    This section contains draft final regulatory text for the sections 
listed under section II. This regulatory text is presented here for use 
by boards that are interested in being recognized by NRC.

Section 35.50  Training for Radiation Safety Officer

    Except as provided in Sec. 35.57, the licensee shall require an 
individual fulfilling the responsibilities of the Radiation Safety 
Officer as provided in Sec. 35.24 to be an individual who--
    (a) Is certified by a specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been recognized by the 
Commission or an Agreement State; or
    (b)(1) Has completed a structured educational program consisting 
of both:
    (i) 200 hours of 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) Radiation biology; and
    (E) Radiation dosimetry; and
    (ii) One year of full-time radiation safety experience under the 
supervision of the individual identified as the Radiation Safety 
Officer on a Commission or Agreement State license that authorizes 
similar type(s) of use(s) of byproduct material involving the 
following--
    (A) Shipping, receiving, and performing related radiation 
surveys;
    (B) Using and performing checks for proper operation of 
instruments used to determine the activity of dosages, survey 
meters, and instruments used to measure radionuclides;
    (C) Securing and controlling byproduct material;
    (D) Using administrative controls to avoid mistakes in the 
administration of byproduct material;
    (E) Using procedures to prevent or minimize radioactive 
contamination and using proper decontamination procedures;
    (F) Using emergency procedures to control byproduct material; 
and
    (G) Disposing of byproduct material; and
    (2) Has obtained written certification, signed by a preceptor 
Radiation Safety Officer, that the individual has satisfactorily 
completed the requirements in paragraph (b)(1) of this section and 
has achieved a level of radiation safety knowledge sufficient to 
function independently as a Radiation Safety Officer for a medical 
use licensee; or
    (c) 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.

Section 35.51  Training for an authorized medical physicist

    The licensee shall require the authorized medical physicist to 
be an individual who--
    (a) Is certified by a specialty board whose certification 
process includes all of the training and experience requirements in 
paragraph (b) of this section and whose certification has been 
recognized by the Commission or an Agreement State; or
    (b)(1) Holds a master's or doctor's degree in physics, 
biophysics, radiological physics, medical physics, or health physics 
and has completed 1 year of full-time training in therapeutic 
radiological 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 at a medical 
institution

[[Page 65795]]

that includes the tasks listed in Secs. 35.67, 35.433, 35.632, 
35.633, 35.635, 35.642, 35.643, 35.645, and 35.652, as applicable; 
and
    (2) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraph (b)(1) of 
this section and has achieved a level of competency sufficient to 
function independently as an authorized medical physicist for each 
type of therapeutic medical unit for which the individual is 
requesting authorized medical physicist status. The written 
certification must be signed by a preceptor authorized medical 
physicist who meets the requirements in Sec. 35.51 or equivalent 
Agreement State requirements for an authorized medical physicist for 
each type of therapeutic medical unit for which the individual is 
requesting authorized medical physicist status.

Section 35.55  Training for an authorized nuclear pharmacist

    The licensee shall require the authorized nuclear pharmacist to 
be a pharmacist who--
    (a) Is certified as a nuclear pharmacist by a specialty board 
whose certification process includes all of the requirements in 
paragraph (b) of this section and whose certification has been 
recognized by the Commission or an Agreement State; or
    (b)(1) Has completed 700 hours in a structured educational 
program consisting of both:
    (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 written certification, signed by a preceptor 
authorized nuclear pharmacist, that the individual has 
satisfactorily completed the requirements in paragraph (b)(1) of 
this section and has achieved a level of competency sufficient to 
function independently as an authorized nuclear pharmacist.

Section 35.190  Training for uptake, dilution, and excretion 
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. 35.100 to be a physician who--
    (a) Is certified by a medical specialty board whose 
certification process includes all of the requirements in paragraph 
(c) of this section and whose certification has been recognized by 
the Commission or an Agreement State; or
    (b) Is an authorized user under Secs. 35.290 or 35.390 or 
equivalent Agreement State requirements; or
    (c)(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) Calibrating 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 written certification, signed by a preceptor 
authorized user who meets the requirements in Secs. 35.190, 35.290, 
or 35.390 or equivalent Agreement State requirements, that the 
individual has satisfactorily completed the requirements in 
paragraph (c)(1) of this section and has achieved a level of 
competency sufficient to function independently as an authorized 
user for the medical uses authorized under Sec. 35.100.

Section 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 by a medical specialty board whose 
certification process includes all of the requirements in paragraph 
(c) of this section and whose certification has been recognized by 
the Commission or an Agreement State; or
    (b) Is an authorized user under Sec. 35.390 or equivalent 
Agreement State requirements; 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 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) Calibrating 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
    (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 written certification, signed by a preceptor 
authorized user who meets the requirements in Secs. 35.290 or 35.390 
or equivalent Agreement State requirements, that the individual has 
satisfactorily completed the requirements in paragraph (c)(1) of 
this section and has achieved a level of competency sufficient to 
function independently as an authorized user for the medical uses 
authorized under Secs. 35.100 and 35.200.

Section 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 a medical specialty board whose 
certification process includes all of the requirements in paragraph 
(b) of this section and whose certification has been recognized by 
the Commission or an Agreement State; or
    (b)(1) Has completed 700 hours of training and experience in 
basic radionuclide handling techniques applicable to the medical use 
of unsealed byproduct material

[[Page 65796]]

requiring a written directive; 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. 35.390(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)(ii)(G)(1), (2), (3), or (4)) as 
the individual requesting authorized user status. The work 
experience must involve--
    (A) Ordering, receiving, and unpacking radioactive materials 
safely and performing the related radiation surveys;
    (B) Calibrating 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;
    (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
    (G) 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) of sodium iodide I-131;
    (2) Oral administration of greater than 1.22 Gigabecquerels (33 
millicuries) of sodium iodide I-131 \1\;
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    \1\ Experience with at least 3 cases in Category (G)(2) also 
satisfies the requirement in Category (G)(1).
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    (3) Parenteral administration of any beta emitter or a photon-
emitting radionuclide with a photon energy less than 150 keV; and/or
    (4) Parenteral administration of any other radionuclide; and
    (2) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraph (b)(1) of 
this section and has achieved a level of competency sufficient to 
function independently as an authorized user for the medical uses 
authorized under Sec. 35.300. The written certification 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. 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(b)(1)(ii)(G)(1), (2), (3), or (4)) as the 
individual requesting authorized user status.

Section 35.392  Training for the oral administration of sodium 
iodide I-131 requiring a written directive in quantities less than 
or equal to 1.22 Gigabecquerels (33 millicuries)

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user for the oral administration of sodium iodide I-131 
requiring a written directive in quantities less than or equal to 
1.22 Gigabecquerels (33 millicuries), to be a physician who--
    (a) Is certified by a medical specialty board whose 
certification process includes all of the requirements in paragraph 
(c) of this section and whose certification has been recognized by 
the Commission or an Agreement State; or
    (b) Is an authorized user under Sec. 35.390(a), Sec. 35.390(b), 
for uses listed in Sec. 35.390(b)(1)(ii)(G)(1) or (2), Sec. 35.394, 
or equivalent Agreement State requirements; or
    (c)(1) Has successfully completed 80 hours of classroom and 
laboratory training, applicable to the medical use of sodium iodide 
I-131 for procedures requiring a written directive; the training 
must include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized 
user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), 
Sec. 35.392, Sec. 35.394, or equivalent Agreement State 
requirements. A supervising authorized user who meets the 
requirements in Sec. 35.390(b), must have experience in 
administering dosages as specified in Sec. 35.390(b)(1)(ii)(G)(1) or 
(2). The work experience must involve--
    (i) Ordering, receiving, and unpacking radioactive materials 
safely and performing the related radiation surveys;
    (ii) Calibrating instruments used to determine the activity of 
dosages and performing checks for proper operation for survey 
meters;
    (iii) Calculating, measuring, and safely preparing patient or 
human research subject dosages;
    (iv) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (v) Using procedures to contain spilled byproduct material 
safely and using proper decontamination procedures; and
    (vi) Administering dosages to patients or human research 
subjects, that includes at least 3 cases involving the oral 
administration of less than or equal to 1.22 Gigabecquerels (33 
millicuries) of sodium iodide I-131; and
    (3) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section and has achieved a level of competency 
sufficient to function independently as an authorized user for 
medical uses authorized under Sec. 35.300. The written certification 
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. A preceptor authorized user, who meets 
the requirement in Sec. 35.390(b), must have experience in 
administering dosages as specified in Sec. 35.390(b)(1)(ii)(G)(1) or 
(2).

Section 35.394  Training for the oral administration of sodium 
iodide I-131 requiring a written directive in quantities greater 
than 1.22 Gigabecquerels (33 millicuries)

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user for the oral administration of sodium iodide I-131 
requiring a written directive in quantities greater than 1.22 
Gigabecquerels (33 millicuries), to be a physician who--
    (a) Is certified by a medical specialty board whose 
certification process includes all of the requirements in paragraph 
(c) of this section and whose certification has been recognized by 
the Commission or an Agreement State; or
    (b) Is an authorized user under Sec. 35.390(a), Sec. 35.390(b), 
for uses listed in Sec. 35.390(b)(1)(ii)(G)(2), or equivalent 
Agreement State requirements; or
    (c)(1) Has successfully completed 80 hours of classroom and 
laboratory training, applicable to the medical use of sodium iodide 
I-131 for procedures requiring a written directive; the training 
must include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2 ) Has work experience, under the supervision of an authorized 
user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), 
Sec. 35.394, or equivalent Agreement State requirements. A 
supervising authorized user, who meets the requirements in 
Sec. 35.390(b), must have experience in administering dosages as 
specified in Sec. 35.390(b)(1)(ii)(G)(2). The work experience must 
involve--
    (i) Ordering, receiving, and unpacking radioactive materials 
safely and performing the related radiation surveys;
    (ii) Calibrating instruments used to determine the activity of 
dosages and performing checks for proper operation for survey 
meters;
    (iii) Calculating, measuring, and safely preparing patient or 
human research subject dosages;
    (iv) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (v) Using procedures to contain spilled byproduct material 
safely and using proper decontamination procedures; and
    (vi) Administering dosages to patients or human research 
subjects, that includes at least 3 cases involving the oral 
administration of greater than 1.22 Gigabecquerels (33 millicuries) 
of sodium iodide I-131; and

[[Page 65797]]

    (3) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section and has achieved a level of competency 
sufficient to function independently as an authorized user for 
medical uses authorized under Sec. 35.300. The written certification 
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. A preceptor authorized user, who meets 
the requirements in Sec. 35.390(b), must have experience in 
administering dosages as specified in Sec. 35.390(b)(1)(ii)(G)(2).

Section 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 source for the uses 
authorized under Sec. 35.400 to be a physician who--
    (a) Is certified by a medical specialty board whose 
certification process includes all of the requirements in paragraph 
(b) of this section and whose certification has been recognized by 
the Commission or an Agreement State; or
    (b)(1) Has completed a structured educational program in basic 
radionuclide handling 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
    (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 running 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 obtained 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 
Committee on Postdoctoral Training of the American Osteopathic 
Association. This experience may be obtained concurrently with the 
supervised work experience required by paragraph (b)(1)(ii) of this 
section; and
    (3) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec. 35.490 or 
equivalent Agreement State requirements, that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and 
(b)(2) of this section and has achieved a level of competency 
sufficient to function independently as an authorized user of manual 
brachytherapy sources for the medical uses authorized under 
Sec. 35.400.

Section 35.491  Training for ophthalmic use of strontium-90

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of strontium-90 for ophthalmic radiotherapy to be a 
physician who--
    (a) Is an authorized user under Sec. 35.490 or equivalent 
Agreement State requirements; or
    (b)(1) Has completed 24 hours of classroom and laboratory 
training applicable to the medical use of strontium-90 for 
ophthalmic radiotherapy; the training must include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (iv) Radiation biology; and
    (2) Supervised clinical training in ophthalmic radiotherapy 
under the supervision of an authorized user at a medical institution 
that includes the use of strontium-90 for the ophthalmic treatment 
of five individuals. This supervised clinical training must 
involve--
    (i) Examination of each individual to be treated;
    (ii) Calculation of the dose to be administered;
    (iii) Administration of the dose; and
    (iv) Follow up and review of each individual's case history; and
    (3) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec. 35.490, 
Sec. 35.491, or equivalent Agreement State requirements, that the 
individual has satisfactorily completed the requirements in 
paragraphs (a) and (b) of this section and has achieved a level of 
competency sufficient to function independently as an authorized 
user of strontium-90 for ophthalmic use.

Section 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 by a specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been recognized by the 
Commission or an Agreement State; or
    (b) Has had 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;
    (4) Radiation biology; and
    (5) Training in the use of the device for the uses requested.

Section 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 a medical specialty board whose 
certification process includes all of the requirements in paragraph 
(b) of this section and whose certification has been recognized by 
the Commission or an Agreement State; or
    (b)(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
    (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 the 
Committee on Postdoctoral Training of the American Osteopathic 
Association. This experience may be obtained concurrently with the 
supervised work experience required by paragraph (b)(1)(ii) of this 
section; and
    (3) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and 
(b)(2) of this section and has achieved a level of competency 
sufficient to function independently as an authorized user of each 
type of therapeutic medical unit for which the individual is 
requesting authorized user status. The written certification must be 
signed by a preceptor authorized user who meets the requirements in 
Sec. 35.690 or equivalent Agreement State requirements for an 
authorized user for each type of therapeutic medical unit for which 
the individual is requesting authorized user status.

    Dated at Rockville, Maryland this 20th day of October, 2000.


[[Page 65798]]


    For the Nuclear Regulatory Commission.
Josephine M. Piccone,
Acting Director, Division of Industrial and Medical Nuclear Safety, 
NMSS.
[FR Doc. 00-27940 Filed 11-1-00; 8:45 am]
BILLING CODE 7590-01-P


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