Current through Register Vol. 43, No. 52, December 26, 2024
(a) A general
license is hereby issued to any physician, veterinarian in the practice of
veterinary medicine, clinical laboratory or hospital to acquire, possess, use
and transfer in accordance with the provisions of subsections (b), (c), (d),
(e), and (f) of this section, the following radioactive materials in
prepackaged units for use in any of the following stated tests:
(1) Iodine-125, in units not exceeding 10
microcuries each, for use in in vitro clinical or laboratory tests not
involving internal or external administration of radioactive material, or the
radiation therefrom, to human beings or animals.
(2) Iodine-131, in units not exceeding 10
microcuries each, for use in in vitro clinical or laboratory tests not
involving internal or external administration of radioactive material, or the
radiation therefrom, to human beings or animals.
(3) Carbon-14, in units not exceeding 10
microcuries each, for use in in vitro clinical or laboratory tests not
involving internal or external administration of radioactive material, or the
radiation therefrom, to human beings or animals.
(4) Hydrogen-3 (tritium), in units not
exceeding 50 microcuries each, for use in in vitro clinical or laboratory tests
not involving internal or external administration of radioactive material, or
the radiation therefrom, to human beings or animals.
(5) Iron-59, in units not exceeding 20
microcuries each, for use in in vitro clinical or laboratory tests not
involving internal or external administration of radioactive material, or the
radiation therefrom, to human beings or animals.
(6) Selenium-75, in units not exceeding 10
microcuries each, for use in in vitro clinical or laboratory tests not
involving internal or external administration of radioactive material, or the
radiation therefrom, to human beings or animals.
(7) Mock Iodine-125 reference or calibration
sources, in units not exceeding 0.05 microcuries of Iodine-129 and 0.005
microcurie of americium-241 each, for use in in vitro clinical or laboratory
tests not involving internal or external administration of radioactive
material, or the radiation therefrom, to human beings or animals.
(8) Cobalt-57, in units not exceeding 10
microcuries each, for use in in vitro clinical or labratory tests not involving
internal or external administration of radioactive material or the radiation
therefrom, to human beings or animals.
(b)
(1) A
person shall not acquire, possess, use or transfer radioactive material
pursuant to the general license issued in subsection (a) of this section until
the person has filed form RH-31, "Registration Certificate In Vitro Testing
with Radioactive Material Under General License," with the secretary and has
received from the secretary a validated copy of the form, with a registration
number assigned, or until the person has been authorized pursuant to K.A.R.
28-35-181d(d) to use radioactive material under the general license issued in
subsection (a) of this regulation.
(2) Each person who files a form RH-31 shall
provide all the information requested by that form.
(c) Each person who acquires, possesses, or
uses radioactive material pursuant to the general license issued in subsection
(a) of this section:
(1) Shall not possess,
at any one time, at any one location of storage or use, a total amount of
iodine-125, iodine-131, selenium-75, cobalt-57 or iron-59 in excess of 200
microcuries;
(2) shall store the
radioactive material, until used, in the original shipping container or in a
container providing equivalent radiation protection;
(3) shall use the radioactive material only
for the uses authorized in subsection (a) of this section;
(4) shall not transfer the radioactive
material except by transfer to a person authorized to receive it under a
license issued by the secretary, the U.S. nuclear regulatory commission or an
agreement state, and shall not transfer the radioactive material in any manner
other than in the unopened, labeled shipping container as received from a
supplier; and
(5) shall dispose of
mock iodine-125 reference or calibration sources in accordance with the
requirements of K.A.R. 28-35-223a.
(d) Each general licensee shall not receive,
acquire, possess, or use radioactive material pursuant to subsection (a) of
this section:
(1) Except as prepackaged units
which are labeled in accordance with the provisions of a specific license
issued by the secretary, the U.S. nuclear regulatory commission, or an
agreement state; and
(2) Unless
the following statement, or a substantially similar statement which contains
the information called for in the following statement, appears on a label
affixed to each prepackaged unit or appears in a leaflet or brochure which
accompanies the package:
"This radioactive material may be received, acquired,
possessed, and used only by physicians, veterinarians in the practice of
veterinary medicine, clinical laboratories or hospitals and only for in vitro
clinical or laboratory tests not involving internal or external administration
of the material, or the radiation therefrom, to human beings or animals. Its
receipt, acquisition, possession, use, and transfer are subject to the
regulations and a general license of the U.S. nuclear regulatory commission or
of a state with which the commission has entered into an agreement for the
exercise of regulatory authority.
(Name of Manufacturer)"
(e) Each person possessing or using
radioactive materials under the general license issued in subsection (a) of
this section shall file a written report with the secretary of any change in
the information furnished on form RH-31. The report shall be filed within 30
days after the effective date of any change.
(f) Any person using radioactive material
pursuant to the general license issued in paragraph (1) of subsection (a) shall
be exempt from the requirements of parts 4 and 10 of these regulations with
respect to radioactive materials covered by that general license, except that
any person using Mock Iodine-125 shall comply with the provisions of K.A.R.
28-35-223a, 28-35-228a and 28-35-229a.
