| (D) investigate and cause a report to be submitted
to the agency for each known or suspected case of radiation exposure
to an individual or radiation level detected in excess of limits established
by this chapter and each theft or loss of source(s) of radiation,
to determine the cause(s), and to take steps to prevent a recurrence;
(E) investigate and cause a report to be submitted
to the agency for each known or suspected case of release of radioactive
material to the environment in excess of limits established by this
chapter;
(F) have a thorough knowledge of management policies
and administrative procedures of the licensee;
(G) identify radiation safety problems;
(H) assume control and initiate, recommend, or provide
corrective actions, including shutdown of operations when necessary,
in emergency situations or unsafe conditions;
(I) verify implementation of corrective actions;
(J) ensure that records are maintained as required
by this chapter;
(K) ensure the proper storing, labeling, transport,
use, and disposal of sources of radiation, storage, and/or transport
containers;
(L) ensure that inventories are performed in accordance
with the activities for which the license application is submitted;
(M) ensure that personnel are complying with this chapter,
the conditions of the license, and the operating, safety, and emergency
procedures of the licensee; and
(N) serve as the primary contact with the agency.
(2) The RSO shall ensure that the duties listed in
paragraph (1)(A) - (N) of this subsection are performed.
(3) The RSO shall be on site periodically commensurate
with the scope of licensed activities to satisfy the requirements
of paragraphs (1) and (2) of this subsection.
(4) The RSO, or staff designated by the RSO, shall
be capable of physically arriving at the licensee's authorized use
site(s) within a reasonable time of being notified of an emergency
situation or unsafe condition.
(5) For up to 60 days each calendar year, a licensee
may permit an authorized user or an individual qualified to be an
RSO to function as a temporary RSO and to perform the duties of an
RSO in accordance with paragraph (1) of this subsection, provided
the licensee takes the actions required in paragraph (1) of this subsection,
and the RSO meets the qualifications in subsection (h) of this section.
Records of qualifications and dates of service shall be maintained
in accordance with subsection (www) of this section for inspection
by the agency.
(h) Training for radiation safety officer. Except as
provided in subsection (l) of this section, the licensee shall require
the individual fulfilling the responsibilities of an RSO in accordance
with subsection (g) of this section for licenses for medical or veterinary
use of radioactive material to be an individual who:
(1) is certified by a specialty board whose certification
process has been recognized by the agency, the NRC, or an agreement
state and who meets the requirements in paragraphs (5) and (6) of
this subsection. (The names of board certifications that have been
recognized by the agency, the NRC, or an agreement state appear on
the NRC's web page at https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html).
(A) To have its certification process recognized, a
specialty board shall require all candidates for certification to:
(i) 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;
(ii) 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
(iii) 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
(B) To have its certification process recognized, a
specialty board shall require all candidates for certification to:
(i) 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;
(ii) have two years of full-time practical training
and/or supervised experience in medical physics as follows:
(I) under the supervision of a medical physicist who
is certified in medical physics by a specialty board recognized by
the agency, the NRC, or an agreement state; or
(II) in clinical nuclear medicine facilities providing
diagnostic and/or therapeutic services under the direction of physicians
who meet the requirements for authorized users in subsections (l),
(jj), or (nn) of this section; and
(iii) 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
(2) meets the requirements of paragraphs (5) and (6)
of this subsection and has completed a structured educational program
consisting of the following:
(A) 200 hours of classroom and laboratory training
in the following areas:
(i) radiation physics and instrumentation;
(ii) radiation protection;
(iii) mathematics pertaining to the use and measurement
of radioactivity;
(iv) radiation biology; and
(v) radiation dosimetry; and
(B) one year of full-time radiation safety experience
under the supervision of the individual identified as the RSO on an
agency, NRC, or agreement state license or on a permit issued by an
NRC master material licensee that authorizes similar type(s) of use(s)
of radioactive material involving the following:
(i) shipping, receiving, and performing related radiation
surveys;
(ii) using and performing checks for proper operation
of dose calibrators, survey meters, and instruments used to measure
radionuclides;
(iii) securing and controlling radioactive material;
(iv) using administrative controls to avoid mistakes
in the administration of radioactive material;
(v) using procedures to prevent or minimize radioactive
contamination and using proper decontamination procedures;
(vi) using emergency procedures to control radioactive
material; and
(vii) disposing of radioactive material; or
(3) is a medical physicist who has been certified by
a specialty board whose certification process has been recognized
by the agency, the NRC, or an agreement state in accordance with subsection
(j)(1) of this section and has experience in radiation safety for
similar types of use of radioactive material for which the licensee
is seeking the approval of the individual as RSO and who meets the
requirements in paragraphs (5) and (6) of this subsection; or
(4) 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 radioactive material for which the individual has RSO responsibilities;
and
(5) has obtained written attestation, signed by a preceptor
RSO, that the individual has satisfactorily completed the requirements
in paragraph (6) of this subsection and in paragraphs (1)(A)(i) and
(ii) or (1)(B)(i) and (ii), or (2), (3), or (4) of this subsection,
and has achieved a level of radiation safety knowledge sufficient
to function independently as an RSO for a medical use licensee; and
(6) 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 RSO, 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.
(i) Radiation safety committee (RSC). Licensees with
broad scope authorization and licensees who are authorized for two
or more different types of uses of radioactive material in accordance
with subsections (kk), (rr), and (ddd) of this section, or two or
more types of units under subsection (ddd) of this section shall establish
an RSC to oversee all uses of radioactive material permitted by the
license.
(1) The RSC for licenses for medical use with broad
scope authorization shall be composed of the following individuals
as approved by the agency:
Cont'd... |
