| (ii) a permit issued by an NRC master material licensee
that authorizes the medical or veterinary use of radioactive material.
(26) Sealed source and device registry--The national
registry that contains all the registration certificates, generated
by both the NRC and the agreement states, that summarize the radiation
safety information for sealed sources and devices and describe the
licensing and use conditions approved for the product.
(27) Stereotactic radiosurgery--The use of external
radiation in conjunction with a guidance device to very precisely
deliver a dose to a tissue volume by the use of three-dimensional
coordinates.
(28) Technologist--Technologist is defined as either
of the following:
(A) in nuclear medicine, a person (nuclear medicine
technologist) skilled in the performance of nuclear medicine procedures
under the supervision of a physician; or
(B) in therapy, as described in subsections (rr) and
(ddd) of this section, a person (radiation therapy technologist or
radiation therapist) who delivers treatments of radiation therapy
under the supervision of and as prescribed by an authorized user who
meets the requirements of subsections (zz) or (ttt) of this section.
(29) Teletherapy--Therapeutic irradiation in which
the sealed source is at a distance from the patient or human or animal
research subject.
(30) Therapeutic dosage--The specified activity or
range of activity of radioactive material that is intended to deliver
a radiation dose to a patient or human or animal research subject
for palliative or curative treatment.
(31) Therapeutic dose--A radiation dose delivered from
a sealed source containing radioactive material to a patient or human
or animal research subject for palliative or curative treatment.
(32) Treatment site--The anatomical description of
the tissue intended to receive a radiation dose, as described in a
written directive.
(33) Type of use--Use of radioactive material as specified
under the following subsections:
(A) uptake, and dilution and excretion studies in subsection
(ff) of this section;
(B) imaging and localization studies in subsection
(hh) of this section;
(C) therapy with unsealed radioactive material in subsection
(kk) of this section;
(D) manual brachytherapy with sealed sources in subsection
(rr) of this section;
(E) sealed sources for diagnosis in subsection (bbb)
of this section; and
(F) sealed source in a remote afterloader unit, teletherapy
unit, or gamma stereotactic radiosurgery unit in subsection (ddd)
of this section.
(34) Unit dosage--A dosage prepared for medical use
for administration as a single dosage to a patient or human or animal
research subject without any further modification of the dosage after
it is initially prepared.
(35) Veterinary use--The intentional internal or external
administration of radioactive material, or the radiation from radioactive
material, to patients under the supervision of an authorized user.
(36) Written directive--An authorized user's written
order for the administration of radioactive material or radiation
from radioactive material to a specific patient or human research
subject, as specified in subsection (t) of this section.
(d) Provisions for research involving human subjects.
(1) A licensee may conduct research involving human
subjects only if it uses the radioactive materials specified on its
license for the uses authorized on the license.
(2) The licensee may conduct research specified in
paragraph (1) of this subsection provided that:
(A) the research is conducted, funded, supported, or
regulated by a federal agency that has implemented the Federal Policy
for the Protection of Human Subjects as required by Title 10, Code
of Federal Regulations (CFR), §35.6 (Federal Policy); or
(B) the licensee has applied for and received approval
of a specific amendment to its license before conducting the research.
(3) Prior to conducting research as specified in paragraph
(1) of this subsection, the licensee shall obtain the following:
(A) "informed consent," as defined and described in
the Federal Policy, from the human research subjects; and
(B) review and approval of the research from an IRB
as required by Title 45, CFR, Part 46, and Title 21, CFR, Part 56,
and in accordance with the Federal Policy.
(4) Nothing in this subsection relieves licensees from
complying with the other requirements of this chapter.
(e) Implementation.
(1) If a license condition exempted a licensee from
a provision of this section or §289.252 of this title on the
effective date of this rule, then the license condition continues
to exempt the licensee from the requirements in the corresponding
provision until there is a license amendment or license renewal that
modifies or removes the license condition.
(2) When a requirement in this section differs from
the requirement in an existing license condition, the requirement
in this section shall govern.
(3) Licensees shall continue to comply with any license
condition that requires implementation of procedures required by subsections
(ggg) and (mmm) - (ooo) of this section until there is a license amendment
or renewal that modifies the license condition.
(f) Specific requirements for the issuance of licenses.
In addition to the requirements in §289.252(e) of this title
and subsections (n) - (q) of this section, as applicable, a license
will be issued if the agency determines that:
(1) the applicant satisfies any applicable special
requirement in this section;
(2) qualifications of the designated radiation safety
officer (RSO) as specified in subsection (h) of this section are adequate
for the purpose requested in the application; and
(3) the following information submitted by the applicant
is approved:
(A) an operating, safety, and emergency procedures
manual to include specific information on the following:
(i) radiation safety precautions and instructions;
(ii) methodology for measurement of dosages or doses
to be administered to patients or human or animal research subjects;
(iii) calibration, maintenance, and repair of instruments
and equipment necessary for radiation safety; and
(iv) waste disposal procedures; and
(B) any additional information required by this chapter
that is requested by the agency to assist in its review of the application;
and
(C) qualifications of the following:
(i) RSO in accordance with subsection (h) of this section;
(ii) authorized user(s) in accordance with subsection
(c)(5) of this section as applicable to the use(s) being requested;
(iii) authorized medical physicist in accordance with
subsection (c)(3) of this section;
(iv) authorized nuclear pharmacist in accordance with
subsection (c)(4) of this section, if applicable; and
(v) radiation safety committee (RSC), in accordance
with subsection (i) of this section, if applicable; and
(4) the applicant's permanent facility is located in
Texas; and
(5) the owner of the property is aware that radioactive
material is stored and/or used on the property, if the proposed facility
is not owned by the applicant. The applicant shall provide a written
statement from the owner or the owner's agent indicating such.
(g) Radiation safety officer.
(1) Every licensee shall establish in writing the authority,
duties, and responsibilities of the RSO and ensure that the RSO is
provided sufficient authority, organizational freedom, time, resources,
and management prerogative to perform the following duties:
(A) establish and oversee operating, safety, emergency,
and as low as reasonably achievable (ALARA) procedures, and to review
them at least annually to ensure that the procedures are current and
conform with this chapter;
(B) ensure that required radiation surveys and leak
tests are performed and documented in accordance with this chapter,
including any corrective measures when levels of radiation exceed
established limits;
(C) ensure that individual monitoring devices are used
properly by occupationally-exposed personnel, that records are kept
of the monitoring results, and that timely notifications are made
in accordance with §289.203 of this title;
Cont'd... |
