Current through Register 1531, September 27, 2024
Except as provided in
105
CMR 120.528, the licensee shall require an
individual fulfilling the responsibilities of the Radiation Safety Officer
(RSO) or an individual assigned duties and tasks as an Associate Radiation
Safety Officer as provided in
105
CMR 120.515 to be an individual who:
(A) Is certified by a speciality board whose
certification process has been recognized by the Agency, Nuclear Regulatory
Commission or an Agreement State and who meets the requirements in 105 CMR
120.524(D). The names of board certifications that have been recognized by the
Agency, Nuclear Regulatory Commission or an Agreement State are posted on the
NRC's Medical Uses Licensee Toolkit Web page. To have its certification process
recognized, a specialty board shall require all candidates for certification
to:
(1)
(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, which
evaluates knowledge and competence in radiation physics and instrumentation,
radiation protection, mathematics pertaining to the use and measurement of
radioactivity, radiation biology, and radiation dosimetry; or
(2)
(a) Hold a master's or doctor's degree in
physics, medical physics, other physical science, engineering, or applied
mathematics from an accredited college or university;
(b) Have two years of full-time practical
training and/or supervised experience in medical physics.
1. Under the supervision of a medical
physicist who is certified in medical physics by a specialty board recognized
by the Agency, Nuclear Regulatory Commission or an Agreement State;
or
2. In clinical nuclear medicine
facilities providing diagnostic or therapeutic services under the direction of
physicians who meet the requirements for authorized users in
105
CMR 120.528,
120.551
or
120.556;
and
3. Pass an examination,
administered by diplomates of the specialty board, that assesses knowledge and
competence in clinical diagnostic radiological or nuclear medicine physics and
in radiation safety; or
(B)
(1) Has
completed a structured educational program consisting of both:
(a) 200 hours of classroom and laboratory
training in the following areas:
1. Radiation
physics and instrumentation;
2.
Radiation protection;
3.
Mathematics pertaining to the use and measurement of radioactivity;
4. Radiation biology; and
5. Radiation dosimetry; and
(b) One year of full time
radiation safety experience under the supervision of the individual identified
as the Radiation Safety Officer on an Agency, Agreement State, or Nuclear
Regulatory Commission license or permit issued by a Nuclear Regulatory
Commission master material licensee that authorizes similar type(s) of use(s)
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, Nuclear Regulatory Commission or an Agreement State
license or permit issued by a Nuclear Regulatory Commission master material
licensee. The full time radiation safety experience must involve the following:
1. Shipping, receiving and performing related
radiation surveys;
2. Using and
performing checks for proper operation of instruments used to determine the
activity of dosages, survey meters, and instruments used to measure
radionuclides;
3. Securing and
controlling radioactive material;
4. Using administrative controls to avoid
mistakes in the administration of radioactive material;
5. Using procedures to prevent or minimize
radioactive contamination and using proper decontamination
procedures;
6. Using emergency
procedures to control radioactive material; and
7. Disposing of radioactive material;
and
(2) Must
obtain a written attestation, signed by a preceptor Radiation Safety Officer or
Associate Radiation Safety Officer who has experience with the radiation safety
aspects of similar types of use of byproduct material for which the individual
is seeking approval as a Radiation Safety Officer or an Associate Radiation
Safety Officer. The written attestation must state that the individual has
satisfactorily completed the requirements in 105 CMR 120.524(B)(1) and
120.524(D), and is able to independently fulfill the radiation safety-related
duties as a Radiation Safety Officer or as an Associate Radiation Safety
Officer for a medical use license; or
(C)
(1) Is
a medical physicist who has been certified by a specialty board whose
certification process has been recognized by the Agency, Nuclear Regulatory
Commission or an Agreement State under
105 CMR
120.525(A), has experience
with the radiation safety aspects of similar types of use of byproduct material
for which the licensee seeks the approval of the individual as Radiation Safety
Officer or an Associate Radiation Safety Officer, and who meets the
requirements in 105 CMR 120.524(D); or
(2) Is an authorized user, authorized medical
physicist, or authorized nuclear pharmacist identified on an Agency, Nuclear
Regulatory Commission or an Agreement State license, a permit issued by a
Nuclear Regulatory Commission master material licensee, a permit issued by an
Agency, Nuclear Regulatory Commission or an Agreement State licensee of broad
scope, or a permit issued by a Nuclear Regulatory Commission master material
license broad scope permittee, has experience with the radiation safety aspects
of similar types of use of byproduct material for which the licensee seeks the
approval of the individual as the Radiation Safety Officer or Associate
Radiation Safety Officer, and meets the requirements in 105 CMR 120.524(D);
or
(3) Has experience with the
radiation safety aspects of the types of use of byproduct material for which
the individual is seeking simultaneous approval both as the Radiation Safety
Officer and the authorized user on the same new medical use license. The
individual must also meet the requirements in 105 CMR 120.524(D).
(D) Has training in the radiation
safety, regulatory issues, and emergency procedures for the types of use for
which a licensee seeks approval. This training requirement may be satisfied by
completing training that is supervised by a Radiation Safety Officer, an
Associate Radiation Safety Officer, authorized medical physicist, authorized
nuclear pharmacist, or authorized user, as appropriate, who is authorized for
the type(s) of use for which the licensee is seeking approval.