Except as provided in Section
335.9160, the licensee shall
require an individual fulfilling the responsibilities of the Radiation Safety
Officer or an individual assigned duties and tasks as an Associate Radiation
Safety Officer under the requirement in subsection
335.1040(b) to
be an individual who:
a) Is certified
by a specialty board whose certification process has been recognized by the
Agency, the U.S. Nuclear Regulatory Commission or an Agreement State and who
meets the requirements described in subsection (f). To have its certification
process recognized, a specialty board shall require all candidates for
certification to meet the following requirements:
1) The candidate shall:
A) Hold a bachelor's or graduate degree from
an accredited college or university in physical science or engineering or
biological science with a minimum of 20 college credits in physical
science;
B) 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; and
C) Pass an examination administered by
diplomates of the specialty board that evaluates knowledge and competence in
radiation physics and instrumentation, radiation protection, mathematics
pertaining to the use and measurement of radioactivity, radiation biology and
radiation dosimetry; or
2) The candidate shall:
A) Hold a master's or doctorate degree in
physics, medical physics, other physical science, engineering, or applied
mathematics from an accredited college or university;
B) Have two years of full-time practical
training or supervised experience in medical physics:
i) Under the supervision of a medical
physicist who is certified in medical physics by a specialty board recognized
by the Commission or an Agreement State; or
ii) In clinical nuclear medicine facilities
providing diagnostic or therapeutic services under the direction of physicians
who meet the requirements for authorized users in Sections
335.9040,
335.9050 or 335.9160;
and
iii) Pass an examination
administered by diplomates of the specialty board that evaluates knowledge and
competence in clinical diagnostic radiological or nuclear medicine physics and
in radiation safety; or
b) Has successfully completed a structured
educational program consisting of both subsections (b)(1) and (b)(2):
1) 200 hours of classroom and laboratory
training in the following areas:
A) Radiation
physics and instrumentation;
B)
Radiation protection;
C)
Mathematics pertaining to the use and measurement of radioactivity;
D) Radiation biology; and
E) Radiation dosimetry; and
2) One year of full-time radiation
safety experience under the supervision of the individual identified as the
Radiation Safety Officer on an Agency, U.S. Nuclear Regulatory Commission, or
Agreement State license or permit issued by a U.S. Nuclear Regulatory
Commission master material licensee that authorizes similar types and uses of
radioactive material. An Associate Radiation Safety Officer may provide
supervision for those areas for which the Associate Radiation Safety Officer is
authorized on an Agency, U.S. Nuclear Regulatory Commission, or Agreement State
license or permit issued by a master material licensee. The full-time radiation
safety experience shall involve the following:
A) Shipping, receiving and performing related
radiation monitoring;
B) Using and
performing checks for proper operation of instruments used to determine the
activity of dosages, instruments used to measure radionuclides and survey
meters;
C) Securing and controlling
radioactive material;
D) Using
administrative controls to avoid mistakes in the administration of radioactive
material;
E) Using procedures to
prevent or minimize radioactive contamination and using proper decontamination
procedures;
F) Using emergency
procedures to control radioactive material;
G) Disposing of radioactive material;
and
3) This individual
must obtain a written attestation, signed by a preceptor Radiation Safety
Officer or Associate Radiation Safety Officer who has experience with the
radiation safety aspects of similar types of use of radioactive material for
which the individual is seeking approval as a Radiation Safety Officer or an
Associate Radiation Safety Officer, that the individual has satisfactorily
completed the requirements in subsections (b)(1), (b)(2) and (f) and is able to
independently fulfill the radiation safety-related duties as a Radiation Safety
Officer or as an Associate Radiation Safety Officer for a medical use license;
or
c) Is a medical
physicist who has been certified by a specialty board whose certification
process has been recognized by the Agency under subsection
335.9150(a) or
the U.S. Nuclear Regulatory Commission or an Agreement State and has experience
with the radiation safety aspects of similar types of use of radioactive
material for which approval of the individual as Radiation Safety Officer or
Associate Radiation Safety Officer is sought and meets the requirements in
subsection (f); or
d) Is an
authorized user, authorized medical physicist, or authorized nuclear pharmacist
identified on an Agency, U.S. Nuclear Regulatory Commission, or Agreement State
license, a permit issued by a U.S. Nuclear Regulatory Commission master
material licensee, a permit issued by an Agency, U.S. Nuclear Regulatory
Commission, or an Agreement State licensee of broad scope, or a permit issued
by a U.S. Nuclear Regulatory Commission master material license broad scope
permittee; has experience with the radiation safety aspects of similar types of
use of radioactive material for which the licensee seeks the approval of the
individual as Radiation Safety Officer or an Associate Radiation Safety
Officer; and meets the requirements in subsection (f); or
e) Has experience with the radiation safety
aspects of the types of use of radioactive material for which the individual is
seeking simultaneous approval both as the Radiation Safety Officer and the
authorized user on the same new medical use license or new medical use permit
issued by a U.S. Nuclear Regulatory Commission master material licensee. The
individual must also meet the requirements in paragraph (f) of this
Section.
f) Has received training
in radiation safety, regulatory issues and emergency procedures for the types
of use for which approval is sought. This training requirement may be satisfied
by completing training that is supervised by a Radiation Safety Officer,
Associate Radiation Safety Officer, authorized medical physicist, authorized
nuclear pharmacist, or authorized user, as appropriate, who is authorized for
the types of use for which the licensee is seeking approval.