| (39) 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, 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) Before 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 department determines that:
(1) the applicant satisfies any applicable special
requirement in this section;
(2) qualifications of the designated 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 department to assist in its review of the
application; and
(C) qualifications of the following:
(i) RSO in accordance with subsection (c)(28) of this
section;
(ii) authorized user(s) in accordance with subsection
(c)(6) of this section as applicable to the use(s) being requested;
(iii) authorized medical physicist in accordance with
subsection (c)(4) of this section, if applicable;
(iv) authorized nuclear pharmacist in accordance with
subsection (c)(5) of this section, if applicable;
(v) ophthalmic physicist in accordance with subsection
(c)(19), if applicable;
(vi) Radiation Safety Committee (RSC), in accordance
with subsection (i) of this section, if applicable; and
(vii) ARSO in accordance with subsection (c)(3) of
this section, if applicable; and
(4) the applicant's permanent facility is located in
Texas.
(g) Authority and responsibilities for the radiation
protection program.
(1) In addition to the radiation protection program
requirements of §289.202(e) of this title, a licensee's management
shall approve in writing:
(A) requests for a license application, renewal, or
amendment before submittal to the department; and
(B) any individual before allowing that individual
to work as an authorized user, authorized nuclear pharmacist, or authorized
medical physicist.
(2) A licensee's management shall appoint an RSO who
agrees, in writing, to be responsible for implementing the radiation
protection program. The licensee, through the RSO, shall ensure that
radiation safety activities are being performed in accordance with
licensee-approved procedures and regulatory requirements. A licensee's
management may appoint, in writing, one or more ARSO to support the
RSO. The RSO, with written agreement of the licensee's management,
must assign the specific duties and tasks to each ARSO. These duties
and tasks are restricted to the types of use for which the ARSO is
listed on a license. The RSO may delegate duties and tasks to the
ARSO but shall not delegate the authority or responsibilities for
implementing the radiation protection program.
(3) 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;
(D) investigate and cause a report to be submitted
to the department 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 department 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 department.
(4) The RSO shall ensure that the duties listed in
paragraph (3)(A) - (N) of this subsection are performed.
(5) The RSO shall be on site periodically commensurate
with the scope of licensed activities to satisfy the requirements
of paragraphs (3) and (4) of this subsection.
(6) 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.
Cont'd... |
